Chapter 3 – Health Care Operations

Policy

• California Correctional Health Care Services (CCHCS) shall provide pharmaceutical services, including prescribed medications accurately and timely, to patients within the California Department of Corrections and Rehabilitation (CDCR).

• All CCHCS pharmacies shall be licensed as correctional pharmacies by the California State Board of Pharmacy (BOP). Pharmacy services within a correctional pharmacy shall be under the direct supervision of a licensed pharmacist.

• CCHCS shall maintain a centralized pharmacy operation to provide advantages of scale and efficiencies related to medication purchasing, inventory control, volume production, drug distribution, workforce utilization, and increased patient safety.

• The Systemwide Pharmacy and Therapeutics Committee shall govern the CCHCS Drug Formulary; govern the cost-effective use of medications; and establish, review, monitor, and approve policies and procedures pertaining to pharmacy and medication services.

Purpose

• To provide guidelines for ordering, processing, documenting, and administering medication to CDCR patients by licensed health care staff and to ensure that all CCHCS pharmacy services comply with federal and state laws, regulations, and standards of practice.

Responsibility

• Statewide

  • CCHCS and CDCR departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available so that licensed health care staff can successfully operationalize this procedure.

  • Oversight of pharmacy services shall be the responsibility of the Statewide Chief of Pharmacy Services, who must be a pharmacist licensed by the BOP.

• Regional

  • Regional Health Care Executives and Regional Pharmacy Services Managers are responsible for operationalizing this procedure at the subset of institutions within an assigned region.

• Institutional

  • The Chief Executive Officer, or designee, is responsible for the operation, monitoring, and evaluation of this policy and associated procedures.

Policy

• Each Correctional Pharmacy shall have a valid, current pharmacy permit issued by the California State Board of Pharmacy (BOP).  Pharmacies preparing intravenous admixtures shall have an additional valid Sterile Compounding Permit issued by the BOP.

Procedure

• Pharmacy

  • California State Board of Pharmacy

    • The institution’s Chief Executive Officer (CEO) shall be designated as the Administrator or Corporate Officer on the pharmacy permit.

    • The Pharmacist II shall be designated as the Pharmacist-in-Charge (PIC) on the permit in accordance with California statutory and regulatory requirements.

    • When a CEO vacancy occurs, the PIC, in coordination with Central Pharmacy Services, is responsible for updating the licenses by submitting the applicable Change of Permit applications within 30 days of the last effective date served as the CEO.

    • In the case of a PIC vacancy, the outgoing PIC shall notify the BOP of their departure within 30 days of the date of that change in status.  The CEO as the hiring authority, in coordination with Central Pharmacy Services, shall submit a Change of PIC application to place a new PIC or acting PIC on the license within 30 days of the last effective date served as the PIC.

      • Prior to assuming the PIC role, the incoming PIC shall have completed the BOP-provided Pharmacist-in-Charge Overview and Responsibility training course, available on the BOP’s website, within two years prior to the date of application and an attestation statement in compliance with California Code of Regulations, Title 16, Section 1709.1, Designation of Pharmacist-In-Charge.

      • Once the incoming PIC has completed the BOP-provided training course, the incoming PIC is responsible for completing an application to replace the previous PIC pursuant to Business and Professions Code, Section 4113, Pharmacist-in-Charge: Notification to Board; Responsibilities.

    • The Regional Health Care Executives and Regional Pharmacy Services Managers shall facilitate the timely notifications and renewals of each pharmacy permit to ensure that vacancies and license expirations do not compromise the validity of a pharmacy permit.

    • The current permit shall be posted in the pharmacy in conspicuous view.

    • The Statewide Chief of Pharmacy Services, as the liaison to the BOP and as the deciding authority on behalf of CCHCS, holds the authority to decide and to take any action regarding BOP licenses, including applying for, renewing, or deactivating any license. Any change to the individual holding the position of the Statewide Chief of Pharmacy Services shall be communicated to the BOP.

    • All licenses issued by the BOP are aligned to expire on November 1 of each year for the Central Pharmacy Services to pay any renewal fees collectively.

    • All changes in CCHCS licensing permits issued by the BOP shall be coordinated through Central Pharmacy Services, who shall coordinate the processing of all fees.

  • National Council for Prescription Drug Programs (NCPDP)

    • The Statewide Chief of Pharmacy Services, or designee, shall be designated as the Authorized Official on the NCPDP provider identification number, who shall ensure the organization’s compliance with Medicare statutes, regulations, and instructions.

  • Drug Enforcement Administration (DEA)

    • For information on DEA registrations, refer to the Health Care Department Operations Manual (HCDOM), Section 3.5.9, DEA Schedule II-V Controlled Substances.

• For information on licensing automated drug delivery systems, see the HCDOM, Section 3.5.4, Automated Drug Delivery System.

• For information on licensing correctional clinics, see the HCDOM, Section 3.5.3, Furnishing or Dispensing Medication to Legally Authorized Persons or Entities: Licensed Correctional Clinics.

Procedure Overview

• This procedure describes the process for furnishing or dispensing medications by the institution’s correctional pharmacy or California Department of Corrections and Rehabilitation (CDCR) Central Fill Pharmacy (CFP) to persons or entities as authorized by law.

Purpose

• To ensure the furnishing or dispensing of medication is in compliance with federal and state requirements and community standards of practice and to establish a procedure for the furnishing of medications to licensed correctional clinics (LCC).

Responsibility

• Statewide

  • CDCR and California Correctional Health Care Services (CCHCS) departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative and clinical systems are in place and appropriate tools, training, technical assistance, and resources are available to ensure the:

  • Furnishing or dispensing of medication from the correctional pharmacy and the CFP are in compliance with federal and state requirements and community standards of practice.

  • Availability of medication or devices to authorized personnel and health care treatment areas when necessary for the treatment of CDCR patients in compliance with federal and state requirements.

• The Systemwide Pharmacy and Therapeutics (P&T) Committee

  • The Systemwide P&T Committee is responsible for:

  • Developing and maintaining policies and procedures pertaining to the provision of medication management.

  • Identifying medications permitted at an LCC for the purpose of performing a diagnostic or treatment procedure whose access shall be restricted to providers only.

• Institutional

  • The Chief Executive Officer (CEO) shall be responsible for ensuring the:

    • Furnishing or dispensing of medication is in compliance with federal and state requirements and community standards of practice within all institutional health care areas.

    • Identification and licensing of all health care treatment areas as LCCs where the provision of medication or devices are necessary for the treatment of CDCR patients, and medications or devices are not being furnished to a licensed unit pursuant to licensure by California Department of Public Health (CDPH) under California Code of Regulations (CCR), Title 22.

  • The Pharmacist-in-Charge (PIC) shall serve as the consultant pharmacist for each of the correctional clinic licenses for that institution to ensure implementation of the policies and procedures developed and approved by the Systemwide P&T Committee and Health Care Department Operations Manual (HCDOM).

  • The CEO, Chief Medical Executive (CME), Chief Physician and Surgeon (CP&S), Supervising Dentist (SD), and Chief Nurse Executive (CNE), shall be responsible for limiting the use of furnished dangerous drugs or dangerous devices to those locations in compliance with federal and state requirements within applicable health care areas.

Procedure

• Furnishing or Dispensing by the Correctional Pharmacy or CFP

  • All correctional pharmacies and the CFP shall comply with the following requirements:

    • California Business and Professions Code (BPC), Division 2, Chapter 9, Articles 1-24.

    • CCR, Title 16, Division 17, Articles 1-11.

    • California Health and Safety Code (HSC), Division 10, Chapters 1-5.

    • All requirements of the Federal Food and Drug Administration and the Drug Enforcement Administration (DEA) as deemed applicable.

  • All correctional pharmacies shall furnish or dispense medications as follows:

    • A pharmacist shall review any medications furnished to a licensed location prior to it leaving the pharmacy.

    • Nonprescription medications shall be furnished as packaged by the manufacturer or distributer with appropriate labeling in accordance with applicable federal and state medication labeling requirements.  Repackaged nonprescription medications shall be labeled with a prescription label for the patient and shall be handled as prescription medication.

    • Prescription medications shall be dispensed to a patient pursuant to a prescriber’s order or prescription and shall be labeled pursuant to BPC, Division 2, Chapter 9, Article 2, Section 4076.  Exceptions to this requirement include the furnishing of medication to:

      • A physician, dentist, podiatrist, or optometrist for use in diagnosing or treating patients.

      • A Correctional Treatment Center, Skilled Nursing Facility, or other facility currently licensed under Division 2 of the HSC.

      • An LCC currently licensed under BPC, Division 2, Chapter 9, Article 13.5, Sections 4187-4187.5.

• Licensed Correctional Clinics

  • The CEO in coordination with the CME, CNE, SD, Senior or Chief Psychiatrist, and PIC shall determine the locations within the institution, codified in a local operating procedure (LOP), that require the availability of medications or devices for the treatment of CDCR patients.

  • Licensing of Correctional Clinics

    • Where the identified locations are not presently operated pursuant to a license issued by the CDPH under HSC, Title 22, correctional clinic licenses shall be obtained from the California State Board of Pharmacy (BOP) pursuant to BPC, Division 2, Chapter 9, Article 13.5 Sections 4187-4187.5.

    • The CEO shall be the administrator on all correctional clinic licenses for that institution.

    • All changes in CCHCS licensing permits issued by the BOP shall be coordinated through Central Pharmacy Services, who shall coordinate the processing of all fees. 

    • When the CEO or PIC positions are vacant, the institution has 30 calendar days to determine a replacement and submit license changes to the BOP.

    • Licenses issued to a correctional clinic by the BOP shall be displayed at the clinic location and are to be renewed annually by Central Pharmacy Services.

  • Pharmacy Policies and Procedures and LOPs Pertaining to an LCC

    • Pharmacy policies and procedures shall be developed and approved by the Systemwide P&T Committee as defined in the HCDOM, Section 1.2.11, CCHCS Systemwide Pharmacy and Therapeutics Committee.

    • All institution LCCs shall adhere to the Systemwide P&T Committee policies and procedures. Pharmacy procedures required while awaiting Systemwide P&T Committee passage of statewide policy and procedures may be implemented via LOP with acknowledgement and approval by the Statewide Chief of Pharmacy Services or designee.  An LOP shall neither contradict nor be inconsistent with statewide policies and procedures.

    • Approvals of pharmacy policies and procedures and LOPs shall be memorialized by designated institution staff on the Correctional Clinic Acknowledgment Affidavit (17A-108), which forms part of the original LCC license application.

    • All policies and procedures shall be available in paper copy or electronic form at each LCC location.

  • Once licensed, an LCC may obtain medications from a correctional pharmacy, the CFP, or from another LCC within the same institution for administration or dispensing to patients eligible for care at the correctional facility.

  • All medication storage within an LCC shall comply with the HCDOM, Section 3.5.16, Medication Inventory Management, Labeling, and Storage.

  • LCC Stock

    • Medications provided to an LCC for administration shall include:

      • Patient-specific medications.

      • CFP-repackaged medications in stock cards or unit doses.

      • Correctional pharmacy-repackaged medications pursuant to the HCDOM, 3.5.18, Repackaging and Compounding of Non-Sterile Medications.

      • Unit-of-use, unit dose, or bulk packaging supplied by the manufacturer.

      • Sterile intravenous compounds prepared pursuant to BPC, Division 2, Chapter 9, Article 7.5, Compounded Sterile Drug Products.

      • Non-sterile compounds prepared pursuant to BPC, Division 2, Chapter 9, Article 7.7, Outsourcing Facilities.

    • All medications shall be labeled pursuant to applicable federal and state laws and applicable US Pharmacopeia chapters pertaining to the type of medication provided.

    • Any medications provided to an LCC shall be labeled with a barcode to permit validating against the Electronic Health Record System (EHRS) order for accuracy prior to administration.

    • Institutions shall stock, at minimum, medications on the Standardized LCC Inventory list in each of its medical LCCs.

    • A pharmacist shall regularly evaluate medications in the LCC for appropriate inventory levels.

  • Medications shall be dispensed or administered from an LCC pursuant to:

    • An order or valid prescription, or

    • A statewide-approved protocol.

  • Stock Medications Restricted to a Provider

    • Stock levels shall be determined by the CEO, CME, CNE, Senior or Chief Psychiatrist, SD, and PIC based upon standards of practice and patient need.

    • A limited number of medications stocked at an LCC may be restricted for use by a provider to perform a diagnostic or treatment procedure conducted within the clinic.

    • Medications for this purpose shall be restricted to those identified by the Systemwide P&T Committee.  Use of these medications within the LCC shall be recorded in the treatment records of the EHRS or Electronic Dental Record System.  Medications include, but are not limited to:

      • Local and topical anesthetics.

      • Ophthalmic mydriatic drops.

      • Fluorescein drops.

      • Hydrogen Peroxide or Betadine for surgical preparation or wound care.

      • Topical antibiotic ointment for wound dressing application.

  • Dispensing of Medications to a Patient

    • The dispensing of medications shall only be performed by a physician and surgeon, a dentist, a pharmacist, or other person lawfully authorized to dispense medications in a clinic setting.  Notwithstanding any other provision of law, a registered nurse (RN) may dispense drugs or devices upon an order by a licensed physician and surgeon or an order by a certified nurse-midwife or an advanced practice provider if the RN is functioning within an LCC pursuant to BPC, Division 2, Chapter 6, Article 2, Section 2725.1.

    • When medications are given to patients for Keep-on-Person (KOP) use, they shall be labeled in accordance with the requirements of the HCDOM, 3.5.8, Prescription/Order Requirements and Medication Availability, and BPC, Division 2, Chapter 9, Article 4, Sections 4076-4076.6. Protocol medications for KOP use must be given to the patient in the manufacturer-supplied, over-the-counter package to include all boxes and materials that include FDA-approved labeling.

  • LCC Records

    • The CEO, in coordination with the CNE and SD, as applicable, shall ensure that records of acquisition, transfer, administration, and dispensing are kept at each LCC location for all medications.

    • All records pertaining to the acquisition, transfer, administration, and dispensing of medications shall be maintained for a minimum of three years and shall be available for inspection by authorized personnel and the institution PIC or designee.  Records of acquisition, transfer, administration, and dispensing for an LCC shall be as follows:

      • Records of acquisition and transfer shall be by electronic requisition and distribution.

        • The LCC requesting the medication shall determine the appropriate location from which the required medication will be obtained. The primary location for obtaining medication shall be the correctional pharmacy.

        • In the event that the medications are needed before the correctional pharmacy can provide them to the LCC, the LCC may requisition medications from another LCC within the same institution.

          • The LCC requesting the medication shall complete a requisition directed to the correctional pharmacy or to the LCC within the same institution providing the medication. 

          • The correctional pharmacy or the LCC within the same institution providing the medication shall confirm the amount of medication being provided and complete the distribution. 

          • No medications shall be moved until this requisition and distribution process is completed. 

          • The LCC receiving the medication shall complete the in-transit review which will close the requisition.

        • When the electronic requisition process is unavailable, approved downtime procedures shall be followed.  Copies of paper records generated shall be stored at both providing and requesting LCC or correctional pharmacy.

      • All LCC records of administration and dispensing shall be kept by the EHRS electronic Medication Administration Record (eMAR) for medications provided by the LCC to the patient pursuant to a prescriber’s order or statewide-approved protocol.  Reports shall be available to track use of medications from the LCC stock based upon the eMAR.

      • When the eMAR is not available for recording administration and dispensing, a paper MAR shall be used.  The resulting paper MAR shall be scanned into the EHRS for the identified patient.

    • Use of correctional clinic stock medications by health care providers for diagnostic or treatment procedures conducted within the LCC, as described in section (d)(2)(H) above, shall be recorded using the treatment records of the EHRS.  No other tracking records shall be required.

  • Automated Drug Dispensing System Within an LCC

    • Medications for an LCC may be stored within an automated drug dispensing system (ADDS).  Medications stored within an ADDS are considered inventory of the correctional pharmacy until removed for dispensing or for administering to a patient pursuant to a prescriber’s order or statewide-approved protocol.

    • The CEO, in coordination with the CME, CP&S, CNE, SD, Senior or Chief Psychiatrist, and PIC, shall determine the quantities and contents of the ADDS.

    • Refer to the HCDOM, Section 3.5.4, Automated Drug Delivery System, for information regarding proper use of an ADDS.

  • DEA Controlled Substances

    • LCCs are NOT permitted to have stock DEA controlled substances without possessing a DEA registration.

    • DEA controlled substances for use by the LCC shall be maintained within the LCC ADDS or shall be dispensed for the patient by the correctional pharmacy as a patient-specific order bearing a label restricting its use to the identified patient.  All DEA controlled substances within an ADDS are considered as a part of the correctional pharmacy and fall under its DEA registration.

    • Refer to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, for information regarding proper handling of controlled substances.

Procedure Overview

• The California Department of Corrections and Rehabilitation (CDCR) and California Correctional Health Care Services (CCHCS) shall ensure each correctional pharmacy maintains a supply of medications with controlled access limited to designated licensed health care staff for timely medication administration in the absence of a patient-specific supply.  The automated drug delivery system (ADDS), also known as an automated dispensing cabinet, shall be an adjunct to medications delivered from the correctional pharmacy or Central Fill Pharmacy (CFP).  The ADDS shall be used to provide drug security and tracking for controlled substances to meet all federal and state requirements.

Purpose

• To provide guidelines for the use of ADDS machines which meet the United States Drug Enforcement Administration (DEA) and the California State Board of Pharmacy (BOP) standards while optimizing secure medication storage and minimizing drug waste.

Responsibilities

• Statewide

  • CDCR and CCHCS departmental leadership at all levels of the organization, within the scope of their authority, shall:

  • Ensure administrative and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available so that licensed health care staff can successfully apply this procedure.

  • Maintain requirements and restrictions for issuance of a chart order pursuant to a protocol.

  • Define circumstances in which chart orders generated pursuant to a protocol shall include auto-verification within the health record.

• The Systemwide Pharmacy and Therapeutics Committee

  • The Systemwide Pharmacy and Therapeutics (P&T) Committee shall:

  • Have overall responsibility for issuing restrictions and limitations on medication inventory for an ADDS.

  • Maintain authorized lists of medications available for Registered Nurse (RN) dispensing from an ADDS or licensed correctional clinic (LCC) stock as authorized by California Business and Professions Code (BPC), Division 2, Chapter 6, Article 2 – Scope of Regulation, Section 2725.1.

  • Issue standardized medication administration instructions for pre-printed labels to be used for RN dispensing when medications are to be administered as Keep-on-Person (KOP).

• The Systemwide Medication Management Subcommittee

  • The Systemwide Medication Management Subcommittee shall have overall responsibility for:

  • Issuing restrictions and limitations on staff access rights for an ADDS.

  • Allocation or re-allocation of the ADDS to optimize use of equipment related to medication management.

• The Statewide Chief of Pharmacy Services

  • The Statewide Chief of Pharmacy Services shall have:

  • Overall responsibility for ADDS server and database oversight including user and drug databases.

  • Overall responsibility for maintenance of ADDS settings including warnings.

  • Oversight of ADDS purchases or lease contracts and service agreements.

• Institutional

  • The Chief Executive Officer (CEO) has overall responsibility for ensuring compliance with this procedure including, but not limited to:

    • Providing plant requirements to support the placement of an ADDS.

    • Continuing compliance with state regulatory requirements, in collaboration with the Pharmacist-in-Charge (PIC), for location and registration of an ADDS.

    • Purchasing of labels and consumables required for using an ADDS.

    • Retaining a service contract in collaboration with the Statewide Chief of Pharmacy Services.

  • The institutional health care leadership team as part of the quality management process has overall responsibility to review:

    • Overall quality of ADDS processes.

    • Compliance with federal and state regulations.

    • Compliance with this procedure.

    • Assignment of consistent and adequate resources.

    • Licensed health care staff training.

  • The Chief Nurse Executive (CNE) shall be responsible for:

    • Maintaining nursing procedures to provide control and accountability for medications after removal from an ADDS.

    • Designating the Supervising RN (SRN) IIs or IIIs or Unit Supervisors responsible for emergency key possession, accessing of an ADDS, and recordkeeping during ADDS downtime procedures.

    • Ensuring adequate training of all licensed health care staff in the proper routine use of an ADDS and ADDS downtime procedures.

    • Ensuring completion of the CDCR 7543, Controlled Substance Reconciliation Mismatch Form.

  • The PIC shall be responsible for:

    • Maintenance, accountability, and accuracy of ADDS inventory.

    • Reviewing of storage locations and inventory organization within an ADDS on a monthly basis.

    • Working in conjunction with the Statewide Chief of Pharmacy Services, or designee, to provide information needed for the maintenance of ADDS databases.

    • Licensing ADDS with the BOP.

    • Preparing and reviewing of ADDS reports.

    • Communicating with the CEO regarding service and quality issues.

    • Assisting in the annual training of all staff in regard to proper ADDS use and ADDS downtime procedures.

    • At minimum, conducting cycle counts as follows:

      • Weekly inventory of all DEA controlled substances within the pharmacy.

      • Monthly inventory of all DEA controlled substances within an ADDS.

      • Monthly inventory of all non-DEA controlled medications within an ADDS.

    • Maintaining records of medication reconciliation within the pharmacy for at least one year and a total of three years.

    • Identifying any trends of medication mismatch and reporting to the institution Medication Management Subcommittee.

    • Ensuring compliance with DEA controlled substances reconciliation requirements pursuant to California Code of Regulations (CCR), Title 16, Division 17, Article 2, Section 1715.65, Inventory Activities and Inventory Reconciliation Reports of Controlled Substances.

    • Ensuring pharmacy staff training and pharmacy implementation of the current DEA Controlled Substances Accountability Training Manual.

  • Licensed health care staff shall comply with this procedure including, but not limited to:

    • Proper use of an ADDS.

    • Proper disposition, storage, labeling, and return of medications after removal from an ADDS.

    • Completion of ADDS training prior to initial use and at least annually thereafter.

    • Compliance with statewide information technology security requirements and restrictions pursuant to the Annual Information Security Awareness Training located on the Information Technology webpage at: https://cdcr.sharepoint.com/sites/cchcs_lifeline_it/SitePages/Information-Security.aspx.

      • All passwords shall be protected from use by persons other than to whom they belong. 

      • All equipment shall be secured when not in use.

Local Operating Procedure Requirements

• Each institution shall be required to maintain a local operating procedure (LOP) which permits continuity of care while using an ADDS.  The LOP shall include, but is not limited to:

• Tracking of items located outside of an ADDS.

• Handling of unit-of-use medication for patient-specific KOP administration after removal from an ADDS while awaiting pharmacy labeling.

• Providing ADDS downtime procedures.

  • Institutional process for management and possession of ADDS keys.

  • During regular business hours of the correctional pharmacy.

  • During hours when the correctional pharmacy is closed.

Procedure

• Preliminary Requirements for an Automated Drug Delivery System

  • Legal Requirements

    • Pursuant to BPC, Division 2, Chapter 9, Article 25, Section 4427.3, ADDS placement in a CDCR institution is limited to licensed units pursuant to both CCR, Title 22, Division 5 and BPC, Division 2, Chapter 9, Article 13.5, Section 4187.

    • An ADDS shall be operated by a correctional pharmacy with a current and valid pharmacy license.  Any drugs within an ADDS are considered owned by the correctional pharmacy until they are dispensed or furnished from the ADDS.

    • An ADDS installed, leased, owned, or operated in California shall be licensed by the BOP. All changes in CCHCS licensing permits issued by the BOP shall be coordinated through Central Pharmacy Services, who shall also process all fees. This license shall be renewed with applicable fees annually by Central Pharmacy Services. The renewal date is the same as for the correctional pharmacy license.

    • Prior to issuance of an ADDS license, the BOP shall conduct a pre-licensure inspection, within 30 calendar days of a completed application for an ADDS license, at the proposed location of the ADDS.  Relocation of an ADDS shall require a new application for licensure.  Replacement of an ADDS requires notification to the BOP within 30 calendar days.

    • Policies and procedures related to an ADDS shall include appropriate security measures and the monitoring of the inventory to prevent theft and diversion.  All policies and procedures shall be maintained in either electronic form or paper form at the location where an ADDS is being used.

    • Pursuant to BPC, Division 2, Chapter 9, Article 25, Section 4427.7, the PIC shall complete a self-assessment for each ADDS evaluating the pharmacy’s compliance with pharmacy laws relating to the use of ADDS annually before July 1 of each odd-numbered year and within 30 days of a newly installed PIC, a newly issued ADDS license, or a change in address of a licensed ADDS location.  All information regarding operation, maintenance, compliance, errors, omissions, or complaints pertaining to an ADDS shall be included in the self-assessment. For any deficiencies identified through the self-assessment, the PIC shall provide a written corrective action plan and timeframe to correct the issues. Completed self-assessments shall be retained for a minimum of three years from the date performed.

    • Should a correctional pharmacy discontinue operation of an ADDS, the PIC shall advise the BOP in writing within 30 calendar days.

  • Physical Requirements and Installation

    • The CEO, in coordination with the Chief Medical Executive (CME), Chief Physician & Surgeon (CP&S), CNE, Supervising Dentist, Chief or Senior Psychiatrist, and PIC, shall determine licensed locations requiring an ADDS.

    • The CEO shall ensure the security, adequate spacing, emergency power (battery backup), and computer connections required for proper functioning of an ADDS.

    • An ADDS shall be located in a licensed unit within a secured medication storage area, free from clutter, distractions, and interruptions. The medication storage area shall remain closed and locked, except for brief authorized staff entrance and exit.

• Administrative Requirements

  • Only licensed health care staff lawfully authorized to administer or dispense a drug may use their own unique identification to utilize an ADDS for completing this task. Each user shall maintain only one permanent user profile.

  • The PIC, or designee, is considered the legal administrator of the ADDS.  The PIC shall be responsible for providing information to the Statewide Chief of Pharmacy Services, or designee, for maintenance of ADDS databases.

  • The PIC in conjunction with the Statewide Chief of Pharmacy Services, or designee, shall maintain the permanent staff access file within an ADDS.  Access to an ADDS shall occur as follows:

    • A new employee shall complete information system requirements for access and use of computers to include required access to an ADDS.

    • The employee’s supervisor, or designee, shall submit a completed Application Access Request via the CCHCS Service Portal for the PIC to approve.  Once approved, the form shall be routed to the Statewide Chief of Pharmacy Services, or designee, to enter the employee into the ADDS staff access database.

    • The Statewide Chief of Pharmacy Services, or designee, shall designate the access parameters for each licensed health care staff granted access to an ADDS.

    • The CNE, or designee, shall provide at least quarterly personnel updates of designated licensed health care staff to the PIC, who shall provide it to the Statewide Chief of Pharmacy Services or designee.

    • The CNE, or designee, shall notify the PIC when access needs to be revoked.  The PIC shall provide it to the Statewide Chief of Pharmacy Services, or designee, who shall remove access of that staff by close of business the next business day.

  • The PIC and CNE, or respective designees, shall be responsible for training their staff in the use of an ADDS and in LOP downtime procedures, including use of the emergency keys. 

  • The PIC and CNE shall review training records of all licensed pharmacy and nursing staff at least quarterly.

    • The PIC and CNE shall receive quarterly reports on expiring training to ensure compliance with due dates.

    • Staff who do not complete their training by their due date shall have their ADDS access revoked until training is completed.

  • The CNE, SRN II or III, or Unit Supervisor may grant temporary access that will expire in three days.  If access is granted over a weekend or holiday, the CNE, SRN II or III, or Unit Supervisor shall grant temporary access every three days until the correctional pharmacy reopens.  Where continuing access is required, refer to Section (e)(2)(C) above.

  • Information security practices shall apply and be enforced for ADDS use and access pursuant to the Annual Information Security Awareness Training located on the Information Technology webpage at: https://cdcr.sharepoint.com/sites/cchcs_lifeline_it/SitePages/Information-Security.aspx.

• Contents of the Automated Drug Delivery System

  • General guidelines for ADDS contents include:

    • Medications stored in an ADDS shall conform to federal and state laws and regulations. 

    • Medication labels shall include: medication name, strength, expiration date, and  quantity (if not apparent from the container).

    • The preferred method for delivery of DEA controlled substances shall be non-patient-specific from an ADDS.  All non-patient-specific DEA controlled substances shall be stored in an ADDS. Where the product characteristics do not permit storage in an ADDS, the medication shall be issued as patient-specific.

    • Over-the-counter RN standardized procedure medications shall not be stored in an ADDS.

    • Inventory within an ADDS shall conform to the requirements, restrictions, and limitations issued by the Systemwide P&T Committee and Systemwide Medication Management Subcommittee.

    • Pharmacy labels pre-printed for RN Dispense medications shall conform to the standard administration instructions as specified by the Systemwide P&T Committee.

    • When stocking DEA controlled substances, high alert medications, and look-alike/sound-alike medications within an ADDS, each medication shall be properly identified and stored in a compartment limited to a single medication with a locking lid.

    • Pharmacy shall identify the locking lid bins containing DEA controlled substances for easy recognition during ADDS downtime (e.g., colored labels, dots, or other distinct markings on the locking lid).

    • Recalled medications shall be removed from the ADDS by the pharmacy for disposition in accordance with the Health Care Department Operations Manual (HCDOM), Section 3.5.16, Medication Inventory Management, Labeling, and Storage.

  • The PIC and the institution Medication Management Subcommittee, in consultation with the CME, CP&S, CEO, CNE, Chief Psychiatrist or Senior Psychiatrist, and Supervising Dentist, or their respective designees, shall prepare, update, and approve the types, dosages, and quantities of drugs stocked in an ADDS to meet the reasonable needs of the institution.

  • The contents of an ADDS shall be reviewed by the PIC in collaboration with the staff listed in Section (e)(3)(B) above for appropriateness on a regular basis but not less than annually.

  • The PIC, or designee, shall restock an ADDS up to the established par level at intervals determined by the electronic prompting of an ADDS.  The stocking and restocking of an ADDS shall be performed by a pharmacist or by a pharmacy technician or intern pharmacist under the supervision of a pharmacist.

  • When stocking an ADDS, the pharmacist or pharmacy technician shall:

    • Select the medication being restocked from an ADDS inventory list.

    • Follow the ADDS prompts to locate the correct medication compartment.

      • For matrix drawer compartments, scan the barcode on the medication and the barcode within the compartment to ensure the medication is being restocked into the correct compartment.

      • For locking lid compartments, follow the ADDS prompts to ultimately open the correct compartment and barcode scan the medication.

  • Where the correctional pharmacy has the Omnicell Controlled Substances Manager® (CSM), the PIC, or designee, shall review the “CSM Exception Report” by the end of the business day pursuant to the HCDOM, Section 3.5.9, DEA Scheduled II-V Controlled Substances.  Where exception transactions exist on the report, the PIC, or designee, shall resolve the exception by the end of the business day.  Where exception transactions cannot be resolved, the transaction shall be handled pursuant to the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

  • Specialized service providers including, but not limited to dentists, optometrists, and respiratory therapists, shall be restricted to only accessing medications consistent with their scope of practice by:

    • Identifying a single drawer or compartment of an ADDS, which the specialized service provider shall access;

    • Specifying the access level for the provider such that the drug can identify whether this provider is to have access; or

    • Licensing the office(s) for the specialized service as an LCC, where medications will be stocked consistent with their specialized scope of practice.  The pharmacy shall monitor requisitions to ensure compliance with the specialized scope of practice.

• Issuing Medications from an Automated Drug Delivery System

  • Medications on the Acceptable Override Medications List (found on the Pharmacy Lifeline at https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Forms-&-Medication-Lists/AcceptableOverrides.pdf) when used as part of a medical procedure, as a diluent, or in an emergent situation may be removed from an ADDS before a pharmacist has verified the order.  This removal will flag as an override in the system and will require a succinct explanation.

  • Any other medications shall be removed from an ADDS only after a pharmacist has verified the order except when pharmacy services are unavailable as described below.

    • If pharmacy services are unavailable and an order has not been verified by a pharmacist and if, in the prescriber’s professional judgment, delay in therapy may cause potential harm, a medication may be removed from an ADDS and administered to a patient under the direction of the prescriber.

      • Pharmacy services shall be considered unavailable when the correctional pharmacy is closed and the after-hours Central Pharmacy Services has not responded.  A lack of response by the after-hours Central Pharmacy Services shall occur when:

        • A message has been sent within the Cerner Message Center to CFP Pharmacy Transfer Message Pool with a subject line that includes: “[facility name] – ADDS removal,” and

        • A phone call has been placed to the after-hours Central Pharmacy Services number, without response, as posted on the Pharmacy Lifeline at: https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Forms-&-Medication-Lists/After-Hours-Pharmacy-Services.pdf

      • For orders placed when pharmacy services are unavailable as indicated in Section (e)(4)(B)1:

        • For computerized provider order entry, the placement of the order with the inclusion of the start time shall be considered the exercising of the provider’s professional judgment that delay in therapy may cause potential harm to the patient.

        • For verbal orders given to a licensed health care staff, a part of the verbal read-back to the provider shall include the start time in addition to the complete order and alerts as needed.  The provider’s authorization to complete the medication order with inclusion of the start time shall be considered the exercising of the provider’s professional judgment that delay in therapy may cause potential harm to the patient.

    • The administration of medications removed from an ADDS by licensed health care staff shall be documented in the electronic health records system (EHRS) Medication Administration Wizard or electronic Medication Administration Record (MAR).  During downtime procedures, administration of medications removed from an ADDS shall be documented on a paper MAR.

  • Withdrawal of medications from an ADDS by licensed health care staff shall occur as follows:

    • Medications shall be withdrawn from an ADDS for one patient at a time and only after entering all required patient-specific information.  Licensed health care staff shall select the medication from the patient-specific profile screen.  If the medication order is not presently listed, licensed health care staff shall enter the required order information into the system, and a medication order override will be generated.

    • Licensed health care staff shall complete all information requested by an ADDS over the course of a medication withdrawal.  Failure to do so may result in a null transaction. 

    • The ADDS may track a limited number of medications which are stored outside of the ADDS cabinet.  These medications shall be taken for administration only upon direction from the ADDS after completing all required information. An institution’s LOP shall identify storage locations for ADDS-tracked medications located outside of the cabinet when implemented.

    • The Systemwide P&T Committee shall authorize a limited number of medications which an RN is authorized to dispense directly to the patient to KOP from an ADDS or LCC stock.  An RN working at an LCC may dispense pursuant to BPC, Division 2, Chapter 6, Article 2 – Scope of Regulation, Section 2725.1.

    • Additionally, DEA controlled substances shall be withdrawn as follows:

      • Licensed health care staff shall follow the prompt provided for locating and opening the compartment that contains the required medication.  The ADDS shall request the countback for all unit doses in the compartment prior to removing the dose. When the countback does not match the ADDS anticipated count, a discrepancy will be created.

      • Should a licensed health care staff waste a dose of DEA controlled substances, staff shall record the waste with a witness at the ADDS cabinet as defined in the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances.  For instructions on the proper disposal of the medication, refer to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

    • Licensed health care staff shall withdraw a medication from an ADDS in the following quantity:

      • When the pharmacy is closed and the medication is packaged as a unit-of-use item (e.g., eye drops, creams), a single unit-of-use package shall be removed from an ADDS for the specific patient and retained for future medication passes.  For RN Dispense exceptions, refer to Section (e)(4)(D)2.

        • If the medication order shall continue after the correctional pharmacy reopens and is desired to be given KOP, two orders are required.  The first order shall be Nurse Administered/Directly Observed Therapy (NA/DOT) administration to cover the interim period, and the second order shall be KOP to continue until therapy is completed.  A pharmacist shall place this label upon the medication which is stored at the LCC.  Once labeled, the unit-of-use medication can be given to the patient for KOP administration. The medication shall not be given to the patient for self-administration until the correctional pharmacy has properly labeled it.

        • If the medication order shall discontinue prior to the correctional pharmacy reopening or if the order is intended to be NA/DOT for the entire duration, the medication shall be ordered as a single NA/DOT order and the medication shall not be given to the patient for self-administration.

      • When multi-dose vials are withdrawn from an ADDS, the beyond-use date shall be written on the vial pursuant to the HCDOM, Section 3.5.16, Medication Inventory Management, Labeling and Storage.  The remainder of the vial shall be kept at a licensed unit for future administrations.

      • All other medications shall be removed in the quantity required for a single administration of the medication with nursing staff returning to the ADDS for each medication pass.

  • Medications removed from an ADDS shall be administered as follows:

    • With the exception of medications authorized by the Systemwide P&T Committee for RN dispensing, medications removed from an ADDS shall have an administration type of NA or DOT.

      • When the correctional pharmacy is closed and a valid order exists as KOP but the licensed health care staff must remove a medication from an ADDS to administer it NA/DOT, a new order of short duration by a provider is required within the health record to permit the recording of medication administration.

      • The after-hours Central Pharmacy Services shall assist in generating the bridging orders to allow for temporary NA/DOT administration.  The following process shall be used to obtain assistance from the after-hours Central Pharmacy Services:

        • A message shall be sent within the Cerner Message Center to CFP Pharmacy Transfer Message Pool with a subject line that includes: “[facility name] – Bridging order needed,” and

        • A phone call shall be placed to the after-hours Central Pharmacy Services number, as posted on the Pharmacy Lifeline at: https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Forms-&-Medication-Lists/After-Hours-Pharmacy-Services.pdf

        • Refer to Section (e)(4)(B)1.a. for CFP after-hours lack of response.

    • For RN dispensing of unit-of-use packages, medications shall be KOP using the following procedures:

      • The correctional pharmacy shall affix labels onto eligible RN Dispense medications. The labels must be approved by the Systemwide P&T Committee.

      • The RN shall:

        • Handwrite the patient’s name and other required information on the label so that it completes all requirements specified in the BPC, Division 2, Chapter 9, Article 4, Sections 4076 and 4076.5.

        • Ensure that the instructions on the medication label correspond to the instructions within the medication order.

          • If the instructions do not match, the medication shall not be furnished to the patient without obtaining a consistent medication order.

          • In the absence of a medication order consistent with the administration directions as printed on the prescription label, medications shall be administered pursuant to Section (e)(4)(D)1 and not dispensed as KOP.

        • Complete the EHRS medication administration process to record the dispensing of the KOP medication to the patient.

  • Medications that have been removed from the packaging issued by pharmacy; appear tampered with; are outdated, contaminated, mislabeled, altered (e.g., crushed), or recalled; or otherwise becomes unsuitable for use shall be disposed of pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff; Section 3.5.16, Medication Inventory Management, Labeling and Storage; and Section 3.5.9, DEA Schedule II-V Controlled Substances. Licensed health care staff shall then record wasted doses at the ADDS.

  • Pharmaceutical Returns

    • Each ADDS cabinet shall be equipped with a return bin.  Any medication removed from an ADDS which remains usable shall be returned to an ADDS return bin.

    • Nursing staff shall identify the patient and the medication and then choose the medication return button.  This will then instruct the nurse to place the doses in the medication return bin.

    • The PIC, or designee, shall refer instances of pharmaceutical waste being placed in the ADDS return bin to the CNE, or designee, for appropriate training.

• Overrides

  • Each business day, the PIC, or designee, shall review medication order overrides from an ADDS for the appropriateness and completeness of an order as specified in the HCDOM, Section 3.5.8, Prescription/Order Requirements and Medication Availability, and for the appropriateness of bypassing the pharmacist’s review.

  • At least quarterly, the PIC, or designated pharmacist, shall review override reports to identify and address barriers to the pharmacist’s review of the medication order prior to medication administration or to refer any identified training issues to the CNE or designee.

• Discrepancies

  • Discrepancy Resolution and Daily Guided Cycle Counts

    • Any discrepancies shall be resolved by licensed health care staff within the same shift.  If unable to resolve, the issue shall be referred to the SRN II or III or Unit Supervisor immediately for resolution within the same shift.

    • At least once every day for each ADDS in use that day, nursing staff shall perform a DEA controlled substances guided cycle count of all locked bins that have been opened since the last guided cycle count.

    • For discrepancies unable to be resolved by the SRN II or III, Unit Supervisor, or line staff, notify the CNE and PIC, and refer to the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

  • The Pharmacy Administrator shall schedule the ADDS Discrepancy Report and the Cycle Count Non-Compliance Report to be generated at least daily and e-mailed to the health care executive team and the PIC or their respective designees.

  • Each business day, the PIC, or designee, shall review discrepancy transactions from an ADDS.

    • If CDC 7221, Physician’s Orders, has been used during downtime of EHRS, the pharmacist shall review the orders for medications withdrawn from an ADDS no later than the next business day.

    • If an ADDS has been manually opened during downtime procedures, pharmacy staff shall perform a complete inventory of the ADDS, correlating the last known inventory for ADDS contents against the present inventory of ADDS contents.  Differences in inventory shall be accounted for by using a paper Inventory Control Method (ICM) process as specified in the institution’s ADDS LOP.  All discrepancies shall be identified and reviewed.

  • Discrepancy reports shall be reviewed at least daily by an SRN II or III or Unit Supervisor for nursing staff issues and the PIC for pharmacy staff issues.  A copy of the resolved discrepancy report shall be submitted to the CNE and the PIC or their respective designees.

  • Unresolved discrepancies or missing medications from an ADDS shall be handled as a theft/loss and immediately reported by the discovering nursing or pharmacy staff or SRN II or III or Unit Supervisor to the CNE and PIC pursuant to the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

• Reconciliation of DEA Controlled Substances

  • DEA Controlled Substances Inventory Managed in an ADDS CSM

    • Whenever possible, DEA controlled substances stored in a pharmacy shall have the inventory managed in an ADDS CSM.

    • Upon procurement of new DEA controlled substances from the wholesaler, a physical inventory count shall be performed. The physical count shall be reconciled against the invoice; and all discrepancies are immediately documented on the invoice, reported to the PIC, and corrected with the pharmaceutical wholesaler. Only medication that has been physically counted shall be entered as received into the CSM.

    • Each business day, the PIC, or designee, shall reconcile all medication quantities entered into the CSM against the invoice to ensure all DEA controlled substances purchased have been properly added to inventory. Any unresolved reconciliations shall be immediately resolved before the close of the business day.

    • Unresolved reconciliations or missing medications from a CSM shall be handled as a theft/loss and immediately reported by the discovering staff to the PIC pursuant to the HCDOM, Section 3.5.26, Break In, Theft/Loss from Pharmacy or Medication Storage Areas.

  • DEA Controlled Substance Removed from ADDS for Administration

    • All actions performed on an ADDS generate a transaction record (e.g., issuance, return, waste) and shall be reconciled daily.

    • At least once daily, an SRN II or III or Unit Supervisor shall review a report of the previous day that reflects the ADDS transaction of DEA controlled substances versus all administrations as recorded on the MAR in EHRS.

    • The SRN II or III or Unit Supervisor shall report on the CDCR 7543 each occurrence of a mismatch between the total units of a DEA controlled substance withdrawn from the ADDS and the total units documented as administered on the MAR.  The CDCR 7543 shall be forwarded to the pharmacy once completed.  The SRN II or III or Unit Supervisor shall work with the medication line staff to resolve the incident and prevent future incidents.

    • The SRN II or III or Unit Supervisor shall compile and review the CDCR 7543 data to identify trends that may indicate process deficiencies. The institution Nursing Subcommittee shall provide oversight, review reported deficiencies, and implement corrective action plans as necessary.

    • The PIC, or designee, shall maintain all CDCR 7543 forms in a readily retrievable format.  The PIC shall report any concerns about controlled substance medication reconciliation to the institution Medication Management Subcommittee.

    • If upon review of the CDCR 7543, a DEA controlled substance reconciliation mismatch cannot be resolved, it shall be considered a true loss.  For all true losses, a corrective action plan shall be implemented to prevent future losses.

    • All true losses shall be handled as a theft/loss and immediately be reported to the CNE and PIC pursuant to the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

• Troubleshooting

  • Reporting ADDS Failure

    • Any issues with the function or contents of an ADDS shall be reported to the PIC and the SRN II or III or Unit Supervisor on duty upon discovery.

    • In the event the correctional pharmacy is unavailable, the SRN II or III on duty shall be notified immediately, and the SRN II or III or Unit Supervisor on duty shall send notification to the PIC, or designee, for follow-up the next pharmacy business day.

  • ADDS Downtime Procedures

    • In the event that a single ADDS malfunctions, the SRN II or III or Unit Supervisor shall post a sign on the cabinet indicating “out of order” and direct licensed health care staff to an alternate ADDS.

      • The inoperable ADDS shall remain secured until repaired without accessing the emergency ADDS keys whenever there is a working ADDS within the same or nearby licensed unit.

      • As the last resort, the institution shall activate the Total ADDS Downtime Procedures in the LOP.

      • When it is necessary to access an ADDS using the ADDS keys, it is the SRN II or III or Unit Supervisor’s responsibility to notify the PIC of emergency access to the ADDS so that the PIC can address the issue the next pharmacy business day.

    • For mechanical issues unrelated to institutional events (e.g., flood, fire, riot, power failure), the SRN II or III or Unit Supervisor on duty shall notify the 24-Hour Omnicell Help Desk at 1-800-910-2220 and provide the serial number located inside the top cabinet of the ADDS.  CCHCS maintains a service and repair contract that requires rapid repairs to malfunctioning ADDS machines.

    • In the event of ADDS failure across the entire institution, the institution shall access after-hours pharmacy services pursuant to the HCDOM, Section 3.5.24, After-Hours Pharmacy Services.

      • Whenever there is a working ADDS within the same or nearby licensed unit, the inoperable ADDS shall remain secured until repaired without accessing the emergency ADDS keys.

      • For rare instances when medications are not available without accessing an inoperable ADDS, the LOP shall include the process for accessing emergency ADDS keys.  As an ADDS is legally considered part of the correctional pharmacy, these keys must be maintained with the strictest of control.

      • Emergency key access to the ADDS

        • The SRN II or III or Unit Supervisor on duty shall be notified of the need for emergency access to the ADDS using the ADDS keys.  All SRN IIs or IIIs or Unit Supervisors shall be trained in the use of keys to access an ADDS during downtime procedures.

        • The CNE, or designee, shall designate the SRN IIs or IIIs or Unit Supervisors responsible for operation and security of an ADDS opened during downtime procedures.  The designated SRN IIs or IIIs or Unit Supervisors shall maintain and retain all records of transactions during the ADDS downtime until:

          • Relieved of their post by another designated SRN II or III or Unit Supervisor; or

          • The ADDS unit has been reassembled and secured.

        • Emergency access keys shall be maintained within a tamper-evident, limited-access key box.  This key box may be kept by Central Key Control or kept in a location occupied by the CNE or designee.

          • If Central Key Control maintains the tamper-evident key box, then routine key control processes shall be followed for checking both the key box and maintenance of the key checkout log.

          • If the CNE, or designee, maintains the tamper-evident key box, then it shall be secured with a tamper-evident numbered seal.  It is the PIC, or designee, who retains unused tamper-evident numbered seals and who shall seal key boxes whenever the tamper-evident seal has been broken.  The PIC, or designee, shall track the seal number used on the tamper-evident key box at all times.  The CNE, or designee, shall check the seal on the tamper-evident key box each shift to confirm its integrity and record the checking of the tamper-evident seal in a key log.  Pharmacy shall be notified when the tamper-evident seal has been broken.  When the tamper-evident seal has been broken, the log shall include:

            • The date and time of issue

            • Printed name and signature of the staff signing out the key

            • Date and time the keys are passed

            • Printed name and signature of the SRN IIs or IIIs or Unit Supervisors giving and receiving keys upon issue and upon passing until Pharmacy takes possession.

          • The SRN II or III or Unit Supervisor on duty shall be the only authorized person to access the keys from a tamper-evident, limited-access key box.

      • Once the emergency has resolved and the emergency ADDS keys are no longer necessary, the SRN IIs or IIIs or Unit Supervisors on duty shall pass the keys to the next oncoming SRN II or III or Unit Supervisor until the PIC or designee takes possession.  The keys shall be returned to a key control location once the tamper-evident key box has been repaired or pharmacy has replaced the tamper-evident seal.

      • Audit Procedures during ADDS Downtime

        • The SRN II or III or Unit Supervisor using the emergency ADDS keys to access an ADDS shall conduct an initial DEA controlled substance inventory with any available licensed health care staff.  This inventory shall be the initial quantity entered into the paper ICM.

        • Should the SRN II or III or Unit Supervisor secure the ADDS, they shall conduct a final DEA controlled substance inventory with any available licensed health care staff.  This inventory shall be the final quantity entered into the paper ICM.

        • The paper ICM shall be reviewed by the PIC or designee on the next pharmacy business day.

• Inspections

  • At least weekly, the correctional pharmacy staff shall:

    • Audit, review, inspect, and restock medications from the “return bin” of an ADDS.  Pharmaceutical returns shall be handled as follows:

      • After auditing the quantity of each medication against the expected returns, medications shall be inspected to ensure that they remain usable for their intended purpose.

        • If the returned medications are no longer usable (e.g., crushed or outdated), a transaction history shall be obtained and the issue referred to the CNE or designee for training.  The medication shall be disposed of pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

        • Pharmacy staff shall run a transaction history and reconcile the quantity identified as returned against the quantity present in the return bin.  Any count discrepancies shall be referred to the PIC and SRN II or III, Unit Supervisor, or designees on duty for resolution.  Any count discrepancies that cannot be resolved shall be handled pursuant to the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

        • Medications issued by pharmacy as patient-specific shall not be returned to an ADDS return bin. If found, any patient-identifying information shall first be removed.  Unusable medications shall be disposed of by pharmacy staff pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.  A transaction history shall be generated and the specific entry referred to the CNE or designee for training.

        • RN Dispense medications issued patient-specific from an ADDS may be returned to the ADDS external return bin if licensed health care staff documents on the label that the medication has not been in the hands of the patient. If found, any patient-identifying information shall first be removed before reissuing.

    • Review null transactions from an ADDS for suspicious behavior.

      • The PIC, or designee, shall provide the SRN II or III or Unit Supervisor with a copy of each report of null transactions involving nursing staff.

      • The PIC, or designee, shall review each null transaction report to assess procedural causes on the part of pharmacy staff and to identify needs for additional training.

  • At least monthly, or more frequently as necessary, a pharmacist at the correctional pharmacy shall:

    • Review transaction records to verify the security and accountability of the system. 

    • Conduct a cycle count of DEA controlled substances in each ADDS.

    • Conduct a cycle count of the non-DEA controlled medications in each ADDS, or if the non-DEA controlled medication cycle counts are performed by a pharmacy technician, complete a random sampling as described in Section (e)(9)(C) prior to signing the CDCR 7477-C, Automated Drug Delivery System Medication Storage Inspection Checklist.

    • Conduct a physical inspection of the drugs to ensure that medications in an ADDS continue to meet drug dating, labeling, and storage requirements (including proper location).

    • Inspect an ADDS for cleanliness.

    • Review the Omnicell PAR vs. Usage Report to look for par levels that may need to be increased or decreased.  When a maximum par level is significantly above the monthly usage (or seven-day maximum dosing for urgent/emergent medications not presently being used), the par level and on-hand quantity shall be reduced.  Failure to review the Omnicell PAR vs Usage Report and adjust par levels and on-hand inventory increases the likelihood that medications expire within the ADDS.  Medications shall be restocked to ensure that adequate supplies are available for continuity of care and for urgent/emergent patient needs.

      • When on-hand quantities have fallen below the minimum par level set, the pharmacy shall restock to bring inventory close to maximum par level.

      • When on-hand quantities are significantly more than usage, the PIC shall consider reduction of inventory and par levels within the ADDS.

    • Review the report of expiring medications in each ADDS.

    • Complete an inspection report pursuant to the HCDOM, Section 3.5.25, Inspecting Medication Storage Areas.

    • Check the seal to the tamper-evident, limited-access key box to ensure that the ADDS emergency keys have not been accessed.  If the seal has been broken:

      • Review the log to identify the date and time that access occurred.

      • Check all inventory at the ADDS to ensure that medications are accounted for.

      • Report the access to the CNE, or designee, to ensure adequate training in maintenance of the tamper-evident key box.

      • Missing medications shall be handled pursuant to the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

  • At least monthly, the pharmacist or pharmacy technician shall:

    • Conduct a cycle count non-DEA-controlled medications in each ADDS.

    • Review expiration dates of medications in each ADDS.

    • If the cycle count or review of expiration dates is performed by a pharmacy technician, a pharmacist shall complete a random sampling to review for accuracy prior to signing the monthly CDCR 7477-C.

  • At least quarterly, the PIC, or designated pharmacist, shall:

    • Review items that have not been used recently to determine whether the aging inventory should still occupy a space in the ADDS.

    • Complete DEA controlled substance recordkeeping, inventory, and reconciliation pursuant to CCR, Title 16, Division 17, Article 2, Section 1715.65, Inventory Activities and Inventory Reconciliation Reports of Controlled Substances and the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances.  Any inconsistencies identified in the reconciliation process shall be handled according to Sections (e)(6)(C) and (e)(6)(D).

  • Upon notification from the PIC, or designee, an SRN II or III or Unit Supervisor shall review ADDS reports for appropriate ADDS use and medication use on the part of nursing staff and to identify needs for additional training.  Reports shall include, but are not limited to:

    • Null transaction reports.

    • Discrepancy reports, refer to Section (e)(6).

    • Overrides, refer to Section (e)(5).

  • All reports shall be retained for a minimum of three years.

Procedure Overview

• The California Correctional Health Care Services (CCHCS) Systemwide Pharmacy and Therapeutics (P&T) Committee shall maintain the systemwide drug formulary. The development of the correctional formulary is based upon evaluations of efficacy, safety, and cost-effectiveness.

Purpose

• To promote rational, safe, clinically appropriate and cost-effective medication therapy within CCHCS and for adding and deleting medications from the formulary. To ensure appropriate use of nonformulary medications.  Prescribing in accordance with the formulary also helps improve continuity of care.

Procedure

• Procedure Overview

  • The Chief of Pharmacy Services shall ensure that the current formulary is readily available in electronic format. 

  • Formulary medication usage is required.  Exceptions are outlined below.

  • Pharmacy shall dispense the most cost-effective, generic equivalent.

  • Providers shall include strong clinical justification for any requests for the use of “brand name only.”

  • Pharmacy shall dispense dosage forms, strengths, and package sizes (if applicable) as listed in the formulary.

• Justification for Nonformulary Drug

  • Justification for prescribing a nonformulary medication shall be included as part of the Computerized Provider Order Entry (CPOE) process.  If CPOE is unavailable, the provider shall provide both the CDC 7221, Physician’s Orders and CDCR 7374, Nonformulary Drug Request, to the pharmacy.

  • Justification for prescribing a nonformulary medication may include, but is not limited to:

    • Patient is a new arrival to a reception center from a non-California Department of Corrections and Rehabilitation (CDCR) facility.

    • Documented treatment failures with medications listed in the formulary.

    • Documented allergy, side effect, or adverse reaction that prevents the use of a formulary medication.

    • Medications recommended by a specialist.

    • Medications having the potential to prevent mortality and morbidity when formulary options do not exist. The requesting clinician may be asked to supply supporting scientific literature.

• Formulary Change Requests

  • The Systemwide P&T Committee has exclusive authority to:

    • Add or delete medications from the formulary.

    • Add or remove use criteria or restrictions from formulary medications.

  • Requests to add, delete, or change restrictions for formulary medications must follow the following process:

    • The provider shall submit a CDCR 7373, Formulary Change Request, and supporting scientific literature to the appropriate discipline as follows:

      • For medical indications, to the institution Chief Medical Executive (CME) or Regional Deputy Medical Executive (DME).

      • For dental indications, to the Regional Dental Director or designee.

      • For mental health indications, to the Chief Psychiatrist, Senior Psychiatrist, or designee. For institutions without psychiatry leadership, requests shall be submitted to the headquarters Chief Psychiatrist or designee.

    • If the above leadership determines that the request should be considered further, the request and supporting documentation shall be forwarded to the Systemwide P&T Committee.

  • Denied formulary addition requests may be reconsidered again 12 months after the initial review or if new practice standards are published indicating a different role for the medication.

  • Pharmacy Services, by delegated authority from the Systemwide P&T Committee, may make non-substantive changes to the CCHCS Drug Formulary in response to market availability.

• Monitoring of Nonformulary Use

  • On a monthly basis, the institution Medication Management Subcommittee shall review nonformulary utilization to ensure that resources are used efficiently, effectively, and safely.

  • On a quarterly basis, the Systemwide P&T Committee shall review nonformulary utilization to ensure that resources are used efficiently, effectively, and safely.

  • On an annual basis, the Systemwide P&T Committee shall review nonformulary use criteria to ensure criteria are up to date and consistent with current practice.

  • For issues related to the misuse or abuse of nonformulary medications, depending on the breadth of the noncompliance, the Systemwide P&T Committee may:

    • Refer concerns over misuse to the institution Medication Management Subcommittee.

    • Refer provider(s) to the institution CME, Regional DME, Chief Psychiatrist, Senior Psychiatrist, or Regional Dental Director for further review.

    • Require prior authorization for the medication.

• Prior Authorization

  • Medications intended to follow this process are those deemed by the Systemwide P&T or Clinical Documentation and Decision Committees to be rarely appropriate or overused.  At least annually, the Systemwide P&T Committee shall review the list of medications that require prior authorization along with use criteria.

  • Within three business days of receiving the prior authorization request, Pharmacy Services at the headquarters level shall review the order for its appropriateness and respond with one of the following actions:

    • Authorize the request, and the provider will enter the order for the correctional pharmacy at the institution to dispense it.

    • Refer to a medical or psychiatry reviewer with a recommendation to reject.

    • Recommend a formulary or nonformulary alternative.

    • Request further information or defer to a medical or psychiatry reviewer for further review.

  • If the prior authorization request is urgent, the prescriber shall contact Pharmacy Services by phone to expedite the request.

  • Prior authorization is valid for one year from the approval date.  Renewed or transferred orders do not need to go through the prior authorization process during this period unless otherwise stated as part of its use criteria.

  • At least every six months, Pharmacy Services at the headquarters level shall review procurement and utilization data and shall report any issues to the Systemwide P&T Committee including, but not limited to:

    • High-cost pharmaceuticals.

    • Potential overutilization concerns.

    • Nonformulary utilization.

Procedure Overview

• This procedure outlines the process for reviewing and approving medications for use in Therapeutic Interchange and Automatic Substitution.  The California Correctional Health Care Services (CCHCS) Drug Formulary creates potential for significant cost savings through Therapeutic Interchange and Automatic Substitution due to the increasing number of medications within therapeutic categories and the wide variation in price among those medications. Authorization to change medications of therapeutic equivalence during national supply shortages may alleviate distribution delays and improve continuity of patient care.  Therapeutic Interchange and Automatic Substitution programs also have the potential to ensure quality of care and improve outcomes for patients.

• The Systemwide Pharmacy & Therapeutics (P&T) Committee shall continually and objectively evaluate and select medications for the Therapeutic Interchange or Automatic Substitution that are most appropriate for the needs of the patient population based on safety, effectiveness, availability, and cost.  The Systemwide P&T Committee is responsible for Therapeutic Interchange or Automatic Substitution product selection, program monitoring and maintenance, and policy and procedure development.  Therapeutic Interchange programs shall be guided by evidence-based prescribing guidelines. The programs shall work in conjunction with other approved CCHCS tools including Care Guides to promote quality medical care.

Procedure

• Therapeutic Interchange or Automatic Substitution Approval Process

  • Proposals for particular Therapeutic Interchange or Automatic Substitution programs shall be submitted to the Statewide Chief of Pharmacy Services or designee for research and development.  Based on the findings, the Statewide Chief of Pharmacy Services, or designee, shall make a recommendation to the Systemwide P&T Committee.

  • Medications chosen for Therapeutic Interchange or Automatic Substitution shall first be evaluated with regard to clinical efficacy and safety using scientific and clinical evidence found in medical literature.  A statement of financial impact shall also be prepared.

  • The Systemwide P&T Committee shall review the evidence and provide final approval or denial for each Therapeutic Interchange or Automatic Substitution proposal.

  • The Systemwide P&T Committee Chairperson shall communicate Therapeutic Interchange or Automatic Substitution approvals to CCHCS clinical leadership, including Chief Executive Officers and the Pharmacists-in-Charge (PIC).

  • Following implementation, the Systemwide P&T Committee shall monitor, measure, and review economic, clinical, or humanistic outcomes for patients treated under the Therapeutic Interchange or Automatic Substitution programs.

• Therapeutic Interchange Procedure

  • Therapeutic interchanges shall only be implemented at the patient level after their provider has signed an approved Therapeutic Interchange Physician Authorization Form, which is on file in the pharmacy.

  • The Therapeutic Interchange Physician Authorization Forms shall be used by each institution’s PIC to obtain provider authorization to generate a new prescription and convert selected patients from the original medication to the designated therapeutic equivalent.

  • The Therapeutic Interchange Physician Authorization Forms shall be used by CCHCS pharmacists to dispense the currently preferred product upon presentation of an order for a patient for one of the interchangeable products.

  • Each prescribing practitioner who has signed a Therapeutic Interchange Physician Authorization Form may revoke such authorization in writing at any time. Such revocation shall be promptly communicated to the PIC.

  • If the ordering provider chooses not to have a particular patient participate in a specific therapeutic interchange, the prescriber shall include “Do not substitute” on the order.

    • The pharmacist shall incorporate the words “Do not substitute” into the medication directions (sig) for inclusion on the medication label and electronic Medication Administration Record (eMAR).

  • If the pharmacist determines that the interchange should not be implemented for a patient because of potential adverse clinical consequences, the pharmacist may dispense the originally prescribed product and document in the health record.

    • If the pharmacist decides not to implement the therapeutic interchange, they shall communicate this decision to the ordering provider.

    • “Do not substitute” designations shall be included in the medication directions (sig) for inclusion on the medication label and eMAR.

  • The pharmacist shall modify the order or enter a new order in the health record.  The new order does not require a co-signature by a provider.  The order shall include the following:

    • A note referencing the therapeutic interchange that includes the original medication, dose, and route ordered.

    • Name of the provider authorizing the therapeutic interchange as the ordering provider.

    • Required order details including dose, route, and duration.

  • The patient shall be informed when a therapeutic interchange has occurred.

  • Signed Therapeutic Interchange Physician Authorization Forms shall be retained by the pharmacy as long as the program is active.

• Automatic Substitution Procedure

  • For medications which are available in different formulations or salts, where the Systemwide P&T Committee deems these to be clinically equivalent, therapeutic substitution at the pharmacy level may be performed by the pharmacist and shall not require the Therapeutic Interchange Physician Authorization Form.

  • The pharmacist shall modify the order or enter a new order in the health record.  The new order does not require a co-signature by a provider.  The order shall include the following:

    • A note referencing the automatic substitution per policy that includes the original medication, dose, and route ordered.

    • Name of ordering provider.

    • Required order details including dose, route, and duration.

Procedure Overview

• An exception can be made to the prohibition against biomedical research pursuant to Penal Code (PC) Section 3502.5 for the case wherein a physician providing care to California Department of Corrections and Rehabilitation (CDCR) patients identifies a medically necessary drug available only through an investigational treatment protocol defined by Code of Federal Regulations, Title 21, Section 312, and obtains informed consent from the patient under PC Section 3521.  Investigational medications shall:

  • Be part of the treatment arm of the investigational protocol only (active drug, not placebo);

  • Not be used unless drug information about the investigational drug is acquired by the physician and distributed to the pharmacy and nursing staff;

  • Follow the nonformulary medication policy and procedures;

  • Be administered as a Directly Observed Therapy medication;

  • Comply with the Health Care Department Operations Manual, Section 3.5.8, Prescription/Order Requirements and Medication Availability.

  • Be included in the patient medication profile.

• The pharmacy shall coordinate with the Principal Investigator (PI) to ensure acquisition, storage, distribution, and disposition of investigational medications.

Purpose

• To define processes for CDCR patients authorized to receive investigational medications.

Procedure

• Investigational medications shall be available in conformance with an investigational treatment protocol approved initially by the Statewide Chief Medical Executive (CME) and reviewed by the California Correctional Health Care Services Systemwide Pharmacy and Therapeutics Committee.

• The facility CME shall request copies of:

  • Approved protocol from the PI;

  • Institutional Review Board approval form;

  • Safety Data Sheet (SDS);

  • Signed informed consent form; and

  • All other documents necessary for the safe administration of the investigational medication.

  • These documents must be readily available to the pharmacy and nursing staff.

• The pharmacy shall utilize the drug information and documentation logs provided by the PI.  The information shall include:

  • Drug designation and common synonyms;

  • Dosage form(s) and strength(s);

  • Usual dosage range, dosing schedule, and route of administration;

  • Indications;

  • Expected therapeutic effect;

  • Potential side effects and adverse effects, including symptoms of toxicity and their treatment;

  • Contraindications;

  • Instructions for dosage preparation and administration, including stability and handling guidelines;

  • Storage requirements;

  • Instructions for disposition of unused doses;

  • Drug interactions, if known; and

  • Names and telephone numbers of the PI and authorized co-investigators

• Copies of the approved protocol and the SDS shall be kept in the pharmacy and shall be distributed to all patient care areas where the medication will be used.

• The prescribing physician is responsible for obtaining an informed consent from the patient prior to prescribing the medication.  The consent shall include the information from the SDS.  A copy of the consent form shall be provided to the institution pharmacy.

• The pharmacy shall retain the files for three years of all investigational medications used. Information to be retained shall include SDS, protocols, inventory records, and dispensing records.

• The nurse shall dispose of, or the pharmacy shall return or transfer, all unused medications according to the specific instructions of the PI upon the conclusion of therapy.

• Investigational product(s) provided by the PI explicitly for an approved protocol shall be logged and inventoried in the pharmacy separately from regular inventory.

• Investigational materials requiring intravenous compounding shall follow United States Pharmacopeia (USP) 797 guidelines for compounding of sterile products.

• Investigational materials involving hazardous materials shall follow USP 800 guidelines for safe handling.

• If the investigational drug is administered parenterally, the patient must be transferred to a facility that has a sterile products preparation license.

Policy

• California Correctional Health Care Services (CCHCS) shall provide prescribed medications accurately and timely to patients within California Department of Corrections and Rehabilitation (CDCR).  The general principles of medication administration in this policy and corresponding sections apply to all medication administration settings, both inpatient and outpatient.

Procedure Overview

• Medication prescriptions/orders shall be prescribed/ordered by licensed health care providers who are credentialed by CCHCS and are authorized to prescribe or issue medication prescriptions/orders within their scope of practice.  To the extent permitted by law, all valid unexpired prescriptions/orders written by CCHCS providers shall be honored by CCHCS health care staff, including health care staff in CDCR institutions other than where the prescription/order originated.  Providers authorized by law to prescribe/order medications shall evaluate current prescriptions/orders of patients prior to the expiration date of the prescriptions/orders.

Purpose

• To ensure medications prescribed/ordered by appropriately licensed and credentialed health care providers are dispensed and administered in accordance with all applicable laws and regulations.

• To ensure continuity of care when patients are transferred between CDCR institutions.

• To standardize the values, units of measurements, computations, abbreviations, and chemical symbols used in the prescribing/ordering and labeling of medications and prescriptions/orders within CCHCS.

Responsibility

• Statewide

  • CCHCS and CDCR departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available so that licensed health care staff can successfully apply this procedure.

• Regional

  • Regional Health Care Executives are responsible for ensuring adherence to this policy at the subset of institutions within their assigned region.

• Institution

  • The Chief Executive Officer, or designee, is responsible for the application, monitoring, evaluation of and compliance with this procedure.

  • The institutional Chief Medical Executive, Chief Psychiatrist, Supervising Dentist, Chief Nurse Executive, and Pharmacist-in-Charge shall maintain a multidisciplinary approach to ensure compliance with this procedure.

Procedure

• Prescription/Order Requirements

  • Medications shall be dispensed/furnished pursuant to prescriptions/orders or system-wide approved protocols and standing orders where health care staff are authorized by the scope of their practice and the staff has been credentialed by CCHCS.

  • Prescriptions/orders shall be limited to the medications listed in the CCHCS Drug Formulary, as clinically appropriate as most of these medications will be readily available.

    • Nonformulary medication orders shall be processed in accordance with the Health Care Department Operations Manual (HCDOM), Section 3.5.5, CCHCS Drug Formulary.

  • Appropriate efforts shall be made to utilize drug regimens approved by the Food and Drug Administration for the prescribed indication and the prescribed dosage before prescribing a medication off-label. Medications for off-label use may be prescribed based on sound scientific evidence, expert medical judgment, or peer reviewed published literature.

    • The provider who prescribes an off-label medication shall exercise clinical judgment based on scientific literature.  The provider is responsible for deciding which medication to use, the medication dosing regimen, and the indication for use for each patient.

    • When requested by the pharmacist, the prescriber shall provide supporting literature and clinical reasoning to the pharmacist prior to dispensing the prescription.

  • All prescriptions/orders for medication shall be entered via computerized provider order entry (CPOE). In addition, all prescriptions/orders for Drug Enforcement Administration (DEA) controlled substances shall be signed utilizing the approved DEA-certified electronic prescription application.

    • If CPOE is unavailable:

      • The prescription/order shall be legibly typed or handwritten on a CDC 7221, Physician’s Orders, signed by the prescribing/ordering provider, and shall also include the prescriber’s printed name and title, or personal rubber stamp identifying their name and title.

      • The prescription/order may be faxed to the pharmacy.  Faxed orders shall be marked “Faxed” on the copy sent to the pharmacy.  The notation should include the time and date faxed.

      • Follow downtime recovery procedures to enter orders into the Electronic Health Record System (EHRS) as soon as functionality returns.

      • DEA-permitted verbal and written prescriptions, as described in HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, shall only be used when the provider lacks electronic access.

  • CCHCS may utilize standing orders approved by the Systemwide Pharmacy and Therapeutics (P&T) Committee.  Standing orders include, but are not limited to:

    • Routine vaccination and preventative health.

    • Medications deemed necessary across the patient population with specified criteria.

  • All medications shall be ordered Keep-on-Person (KOP) unless the prescriber determines that they cannot be safely or properly self-administered or unless the medications are required by policy to be Nurse Administered (NA) or Directly Observed Therapy (DOT).

    • The prescriber’s decision that medication be administered NA or DOT, due to safety reasons, may be informed by notifications from Mental Health or through consultation with Mental Health. 

    • For patients in outpatient housing units and Restricted Housing Units, all rescue inhalers, nitroglycerin, and oral glucose shall be prescribed and dispensed as KOP, unless the prescriber specifically orders NA due to strong clinical justification to do so (e.g., physical or mental inability to self-administer or danger to self).  The clinical justification shall be documented in the health record and shall be based upon information contained in the health record or upon results from the formal mental health consultation addressing mental health barriers to self-administration of medication.  

    • Medications prescribed for mental health indications shall not be prescribed KOP with the exceptions specified on the KOP-Permitted Mental Health Medication List. 

    • All oral DEA controlled substances, except those used in the treatment of substance use disorder and approved for KOP by the Systemwide P&T Committee, shall be prescribed DOT; refer to the HCDOM, Section 3.5.29, Medication Administration, for rules and exceptions.

    • Other recommendations on selecting an administration type are available on Lifeline: https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Best-Practices/kopnadot-recommendations.pdf

  • When initiating a new medication, if clinically appropriate, the prescriber should include a start date two days into the future to allow time for the pharmacy to process the order and the Central Fill Pharmacy to fill the order. 

  • When prescribing medications, the prescriber shall explain to the patient how to take the medication (prescription instructions) and when medications are permitted to be kept on their person at all times including during transportation as specified on the Rescue Medications list.  The prescriber shall ensure that effective communication is provided and appropriately documented.

  • Prescriptions/orders shall include:

    • Generic name of medication.

    • Dosage.

    • Specific directions for use.

    • Route of administration.

    • Frequency of administration.

    • Time and date of prescription/order.

    • Duration of therapy in days, doses, hours, minutes, or weeks.

    • Patient’s name, CDCR number, date of birth, and housing location (as applicable).

    • Drug allergies.

    • Administration status (e.g., KOP, NA, DOT).

    • Number of days supply of KOP medications per dispense, if other than 30 days.

    • Language required (if other than English).

    • Indication for use when medication is ordered as needed (PRN) or where formulary restrictions require the indication to be provided on the order.

    • Prescriber’s signature and either the prescriber’s printed name or personal rubber stamp.

  • Prescriptions/orders missing elements shall be returned to the prescriber for completion before verification by the pharmacist pursuant to EHRS Clinical Leadership Advisory Committee Approved Workflows, Workflow 700-210, Pharmacy, Incomplete and Clarification Workflow. 

  • In the event that EHRS is not available, health care staff shall screen prescriptions/orders to the extent possible for inclusion of the required elements of a prescription/order before transmitting the prescription/order to the pharmacy.

  • Prescriptions/orders for PRN medications shall be written as explicitly as possible and shall include the following:

    • Indication for use.

    • One specific dose and dosing criteria per prescription/order.  If more than one dose is necessary (e.g., take one tablet for moderate pain and two tablets for severe pain), then multiple prescriptions/orders are required.

  • Specific frequency (e.g., every eight hours); range frequency shall not be used (e.g., every four to six hours). 

  • Medication prescribed with PRN directions for which there is clear pharmacologic rationale requiring it to be administered on a scheduled basis shall be clarified by the pharmacist with the prescriber.  It is unacceptable to inappropriately prescribe for PRN administration a medication which requires regularly scheduled administration for efficacy simply to avoid noncompliance notifications.

  • Over-the-Counter (OTC) Medications:

    • An OTC Canteen is available to ensure all incarcerated persons have equal access to OTC products without cost or the need for nurse protocol or a prescription, pursuant to the HCDOM, Section 2.1.3, Over-the-Counter Products.

  • For policies and procedures regarding prescribing DEA controlled substances, criteria relevant to the prescribing/ordering of DEA controlled substances including those used for substance use disorder treatments, refer to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances.  All pharmacists have the responsibility to ensure that DEA controlled substances prescriptions/orders have been issued by appropriately authorized providers.

• Additional Requirements for Mental Health Medications

  • Mental health medications, which only include those written by a psychiatrist or a psychiatric nurse practitioner (working under the supervision of a psychiatrist) for a mental health indication, are to be prescribed/ordered as NA or DOT with the exceptions specified on the KOP-Permitted Mental Health Medication List.

  • KOP may be permissible for some medications used for symptomatic relief or as part of a prophylactic regimen (e.g., laxatives for clozapine) when written by a psychiatrist.  These medications are specified in the CCHCS Drug Formulary or the Systemwide P&T Committee communications.

• Use of Abbreviations

  • The use of abbreviations in prescriptions/orders increases the risk of medication errors and should be limited to the extent possible.

  • Abbreviations that may be used include:

    • KOP, DOT, and NA

    • Standardized Latin such as PR (rectally), PRN (as needed), OU (each eye), BID (twice a day), and TID (three times a day)

  • A list of nationally recognized, high-risk abbreviations which should not be used is located on Lifeline’s Pharmacy page: https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/FormsMedLists/Do-Not-Use-List-of-Abbreviations.pdf

  • Chemical symbols shall not be used in prescriptions/orders except where authorized by the Systemwide P&T Committee.

• Use of Metric System

  • Prescriptions/orders and prescription labels shall contain the dose in metric units.

  • Prescriptions/orders with a decimal shall include a leading zero (e.g., 0.2 mg not .2 mg) but shall not include a trailing zero (e.g., 2 mg not 2.0 mg).

• Tablet-Splitting

  • To the extent possible if clinically appropriate, prescriptions/orders shall be written to refrain from splitting tablets.  When appropriate, pharmacists shall select products, suggest alternative medications to providers, and recommend dosing changes to minimize splitting tablets. 

  • Where a half tablet is necessary, the pharmacist shall select a scored product for easier and more consistent administration.

  • If a pill cutter is required for the dose, the medication shall be administered as an NA or DOT, and a patient-specific pill cutter shall be issued by the pharmacy to the nursing staff.  A pill cutter shall not be allowed in the possession of patients.

• Telephone/Verbal Prescriptions/Orders Excluding DEA Controlled Substances

  • Telephone/verbal prescriptions/orders shall be kept to a minimum and shall be received only by licensed nursing staff, and other licensed staff consistent with the scope of their practice. 

  • The staff receiving the telephone/verbal prescription/order shall enter the prescription/order via CPOE or write down the prescription/order on the CDC 7221.  The staff shall then read back the prescription/order, allowing the provider to validate the correct transcription.  The staff transcribing an order to the CDC 7221 shall indicate “phone with read back” or “verbal with read back” and shall sign the transcribed prescription/order with date, time, name, and title. 

  • For either CPOE or CDC 7221, the individual transcribing the telephone/verbal prescription/order shall be indicated.

  • Telephone/verbal prescriptions/orders shall be signed or electronically authorized via CPOE by the provider or another primary care provider (advanced practice provider, dentist, physician, or psychiatrist) as designated by the prescriber or Chief Medical Executive (CME)/Chief or Senior Psychiatrist/Supervising Dentist, or designee, within 48 hours or no later than the next business day following a weekend or holiday.

• Telephone/Verbal Prescriptions/Orders for DEA CIII-V Controlled Substances

  • For telephone/verbal prescriptions/orders given to licensed nursing staff, the provider who initiated the prescription/order is required to sign the prescription/order in the DEA-certified electronic prescription application or make telephone contact with the pharmacist for generating the DEA-compliant verbal prescription/order.

  • Telephone/verbal prescriptions/orders for DEA CIII-V controlled substances shall be signed prior to a dispense from pharmacy, or within 48 hours or no later than the next business day following a weekend or holiday for medications administered from an automated drug dispensing system (ADDS).

• Duration of Prescriptions/Orders for Outpatients

  • Duration for medication prescriptions/orders shall be specified in days, doses, hours, minutes, or weeks. 

  • Mental health medications, which only include those with a mental health indication written by a psychiatrist, or a psychiatric nurse practitioner (working under the supervision of a psychiatrist), may be prescribed/ordered for a maximum duration of 180 days.  The Mental Health Services Delivery System Program Guide requirements for minimum frequency of patient appointments are not impacted by this procedure. 

  • Maximum duration for prescriptions/orders for DEA CII-V controlled substances shall comply with the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, Section (d)(4)(B), Duration of Controlled Substances Orders.

  • All other medications may be prescribed/ordered for a maximum of 360 days, except where otherwise restricted by the formulary, regulation, or policy.  When clinically appropriate, the duration of prescription orders shall be written in increments of 30 days and shall not exceed 360 days.

• Scheduling of Non-Daily Medications

  • Medications prescribed/ordered twice weekly (e.g., isoniazid and vitamin B6) shall preferably occur on Tuesdays and Fridays unless otherwise specified by the prescriber.  

  • Excluding one-time doses and vaccines, medications prescribed/ordered weekly, every two weeks, three weeks or four weeks (e.g., long-acting depot mental health injections) shall preferably occur on Tuesdays unless otherwise specified by the prescriber.

  • The scheduled days of administration shall be included in the directions for administration on the Medication Administration Record (MAR) either via CPOE or by pharmacy entry.

• Mandatory Crush/Open Medications List

  • The Systemwide P&T Committee mandates that certain medications be administered “Crush/Open and Float” as appropriate per the formulation.

  • Medications on the Systemwide P&T Committee’s Mandatory Crush/Open Medications List shall include the words “Crush/Open and Float” in the directions on the label for inclusion in the medication profile and MAR.

    • This labeling shall be automatically applied to all eligible medications regardless of whether the provider’s prescription/order included “Crush/Open and Float” directions.

    • Any prescription/order from a provider to request an exception from “Crush/Open and Float” administration for an eligible medication requires approval from the institution’s CME, or designee, or Chief/Senior Psychiatrist or designee.

• Monitoring and Prescription/Order Related Problems

  • A pharmacist shall be responsible for screening all prescriptions/orders for potential problems including, but not limited to, drug-drug interactions, drug-food interactions, drug-condition interactions, contraindications, allergies, unclear rationale of therapy or polypharmacy, duplicate therapy, and legibility (where applicable). 

  • A pharmacist, as part of the interdisciplinary patient care team, shall be involved in the ongoing assessment of a patient’s drug therapy within the legal limits of their scope of practice.

  • Organization-approved point-of-care immunizations and protocols as well as prescriber-ordered medications for emergent care where in the prescriber’s professional judgment, a delay in therapy may cause patient harm, a medication may be removed from an ADDS or from licensed correctional clinic (LCC) stock and administered to a patient prior to screening by a pharmacist. Any removal of medication from an ADDS or LCC stock shall be documented and provided to the correctional pharmacy for review. 

  • A pharmacist shall contact the prescriber directly for clarification.  If the prescriber cannot be reached, pharmacy staff shall follow EHRS Clinical Leadership Advisory Committee Approved Workflows, Workflow 700-210, Pharmacy, Incomplete Clarification Workflow. 

  • Prescription/order changes, clarification, or cancellations shall be received from the provider via CPOE or through a telephone or written prescription/order.

  • Problems shall be resolved ensuring that applicable turnaround times are met.

• Discontinued, Suspended, or Hold Prescriptions/Orders

  • An order shall be obtained from a provider before any prescribed medication is withheld from a patient, unless administration is clinically contraindicated.  Blanket orders to withhold medications from groups of patients are not permissible.

  • When a KOP medication is to be discontinued due to clinical reasons (e.g., drug-drug interaction, pending surgery), the primary care or mental health team shall notify the patient.

  • Within EHRS, when a medication is to be held, the provider shall discontinue the current prescription/order and generate a new prescription/order with a start date/time for the intended resumption.  When a “hold” prescription/order is written on a CDC 7221, it shall be interpreted to mean “discontinue.”  If the specific time or date to resume medications is not clear on the CDC 7221, the pharmacy shall immediately contact the prescriber for clarification.  If the provider is unavailable, clarification shall be sought via the process outlined in EHRS Clinical Leadership Advisory Committee Approved Workflows, Workflow 700-210, Pharmacy, Incomplete and Clarification Workflow.

• Product Substitutions

  • Generic equivalent medications shall be automatically substituted by the correctional pharmacy in place of brand name medications if available. 

  • Specific requests for the use of a brand name medication shall be regarded as formulary exceptions and shall follow the nonformulary approval process with strong clinical justification for why a generic or an alternative generic medication is inappropriate. 

  • The correctional pharmacy shall substitute alternate strengths of the generic equivalent medication to equal the dose prescribed as necessary to maintain continuity of care.

  • For medications which are available in different formulations or salts, when the Systemwide P&T Committee deems these medications to be clinically equivalent, therapeutic substitution may be performed by the pharmacist in accordance with the HCDOM, Section 3.5.6, Therapeutic Interchange and Automatic Substitution.

• Medication Availability

  • Most formulary NA or DOT medications shall be readily available through the licensed correctional clinic (LCC) or automated drug delivery system (ADDS) supplies for administration following a pharmacist’s authorization.

  • During business hours, if the medication is unavailable through the LCC, pharmacy staff shall provide the ordered medications.

    • Non-urgent new medication orders received by pharmacy on any business day shall be available to the patient no later than three business days unless otherwise ordered (e.g., order specifies medication to start today).

    • Non-urgent renewed medication orders received by pharmacy on any business day shall be available to the patient prior to exhaustion of previous medication supply unless otherwise ordered (e.g., order specifies medication to start today).

  • If the correctional pharmacy is closed, licensed health care staff shall contact the after-hours Central Pharmacy Services to authorize the order.  Licensed nursing staff shall then obtain the ordered medication from the LCC or ADDS.  This medication shall be administered NA or DOT (or may be KOP if available for a Registered Nurse (RN) to dispense) and shall be documented on the MAR.

    • Instructions to contact the after-hours Central Pharmacy Services are available on Lifeline at: https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Forms-&-Medication-Lists/After-Hours-Pharmacy-Services.pdf

    • If the medication is available in another LCC within the same institution, licensed health care staff in an LCC shall transfer a limited medication supply and document the transaction as specified in the HCDOM, Section 3.5.3, Furnishing or Dispensing Medication to Legally Authorized Persons or Entities: Licensed Correctional Clinics.

    • If the after-hours Central Pharmacy Services has not responded to the request (attempted through both the Cerner Message Center and by phone) and if, in the prescriber’s professional judgment, delay in therapy may cause harm, a medication may be removed from an ADDS and administered to a patient under the direction of the prescriber.  This medication shall be administered NA or DOT (or may be KOP if available for an RN to dispense in accordance with the HCDOM, Section 3.5.4, Automated Drug Delivery System) and shall be documented on the MAR.

  • Medications for New Arrivals

    • Patients arriving in the institution from a site other than a CDCR institution who are on prescription medications shall be seen by a health care provider or have their prescription medications ordered within eight hours of arrival to prevent any interruption in medication delivery.  The medication shall be administered at the next dosing time and no later than the next calendar day.

    • Patients arriving from CDCR institutions shall be provided medications for which they have active orders; orders that are at or near expiration shall be renewed by a health care provider within eight hours of arrival, as indicated.

  • Start Time of Medication Orders

    • Medications may not be ordered “STAT” in the outpatient clinic setting in CDCR. STAT orders are appropriate only in the Triage and Treatment Area, urgent/emergent treatment areas, or Licensed Inpatient areas. 

    • If a medication should be started on the same day, the provider shall adjust the start date and time during order entry and may need to verbally notify the medication administration staff of the same-day order.

    • If any STAT/same-day order medication is unavailable, the prescriber or on-call provider shall immediately be notified for treatment recommendations.

  • Medications Not Available

    • Patient Out of Medication – When licensed nursing staff become aware that a patient with a valid routine medication order has run out of their medication supply (KOP, NA, or DOT), licensed nursing staff shall make every effort to promptly obtain the medication as appropriate.

    • In situations where medications are not available locally, the prescriber or on-call provider shall be contacted for appropriate orders depending on clinical need until the pharmacy can procure the required medications per routine process.

• Medication Refills

  • Medications may be refilled automatically in the pharmacy dispensing database in accordance with policy.  Providers should consider discontinuing auto-refill for those patients who repeatedly miss doses despite appropriate patient counseling. 

  • CDCR 7362, Health Care Services Request Form, Refill Request

    • KOP medications that are not included in the auto-refill process shall include the words “Request Refill” on the medication label.  Patients must request refills of these medications using the CDCR 7362 or other approved processes.

    • The completed CDCR 7362 shall be submitted pursuant to the established CDCR 7362 process.  Licensed nursing staff shall process refill requests according to Local Operating Procedures (LOP).

  • NA or DOT medications that are not included in the auto-refill process shall include the words “Request Refill” on the medication label.  Licensed nursing staff shall process refill requests for these medications according to the LOP.

• Medication Renewals

  • Patients may request medication renewals by submitting a CDCR 7362 indicating their medication needs. 

  • The prescriber is responsible for renewing medication orders with appropriately timed follow-up visits to facilitate medication continuity. 

  • Licensed nursing staff shall request a new order from a prescriber when it is determined that an order for a medication for an ongoing health condition has expired.

  • Patients shall be scheduled to be seen by the prescriber prior to expiration of their medication when required by institution policy or when indicated.

Procedure Overview

• The correctional pharmacy shall maintain a system of accountability for Drug Enforcement Administration (DEA) Schedule II, III, IV, and V (CII-V) controlled substances.  This includes, but is not limited to, documenting purchases, receipt, storage, chart orders, prescriptions, dispensing, administration, return, and destruction for security and audit purposes.  The correctional pharmacy shall complete a quarterly reconciliation of all CII controlled substances.  All pertinent records and documentation shall be accurately completed and maintained.

• CII-V controlled substances shall be stored in automated drug delivery systems (ADDS), whenever possible to maximize security and control.  All staff shall follow procedures defined in the Health Care Department Operations Manual (HCDOM), Section 3.5.4, Automated Drug Delivery System, for use of an ADDS.  All CII-V controlled substances stored within an ADDS are considered correctional pharmacy inventory until they are issued for patient administration.

• The theft, loss, and waste of controlled substances shall be reported and documented to comply with federal and state regulations; the HCDOM, Section 3.5.26, Break-In, Theft/Loss From Pharmacy or Medication Storage Areas; and HCDOM, Section 5.1.4, Reporting of Actual or Suspected Incidents of Fraud, Errors, and Improper Governmental Activities.

Purpose

• To ensure that CII-V controlled substances are managed and accounted for in compliance with federal and state regulations and are not lost or diverted for misuse or abuse, and breaches of security or losses due to theft or another cause are addressed promptly.

Responsibility

• Statewide

  • California Department of Corrections and Rehabilitation (CDCR) and California Correctional Health Care Services (CCHCS) departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available so that licensed health care staff can successfully implement this procedure.

• The Systemwide Pharmacy and Therapeutics (P&T) Committee

  • The Systemwide P&T Committee shall have overall responsibility for issuing restrictions and limitations on medication inventory and develop guidelines to which controlled substances may be dispensed as Keep-on-Person (KOP).

• Institutional

  • The Chief Executive Officer (CEO) has overall responsibility for ensuring the implementation and enforcement of this procedure.

  • The Chief Medical Executive shall be responsible for ordering, storage, and provider access to California-approved tamper-resistant prescription blanks.

  • The Chief Nurse Executive (CNE) shall be responsible for the establishment and maintenance of nursing procedures to provide control and accountability for CII-V controlled substances issued as a patient-specific supply, removed from an ADDS, or obtained during ADDS downtime procedures.

  • The Pharmacist-in-Charge (PIC) shall be responsible for:

    • Establishing and maintaining accountability for and accuracy of CII-V controlled substances within the correctional pharmacy and all ADDS.

    • Compliance with all federal and state laws pertaining to pharmacy and the ordering, storage, management, handling, dispensing, wasting and accountability for controlled substances.

    • Conducting a daily count of all DEA controlled substances which were accessed, received, wasted, dispensed, or removed from usable inventory on that business day.

    • Conducting a weekly count of all DEA controlled substances in the correctional pharmacy.

    • Conducting a monthly count of DEA controlled substances in each ADDS which shall be maintained in the Inventory Control Method (ICM).

    • Compliance with controlled substances reconciliation requirements pursuant to California Code of Regulations (CCR), Title 16, Division 17, Article 2, Section 1715.65, Inventory Reconciliation Report of Controlled Substances.

    • Confirming prescriptions for CII-V controlled substances dispensed to released patients have been reported to the Controlled Substance Utilization Review and Evaluation System (CURES) in compliance with California Health and Safety Code (HSC), Division 10, Chapter 4, Article 1, Section 11165, Controlled Substance Utilization Review and Evaluation System: Establishment; Operation; Funding; Reporting to Department of Justice.

    • Compliance with the DEA Controlled Substances Accountability Training Manual

  • Providers authorized to prescribe controlled substances shall:

    • Obtain and maintain a current DEA registration for all controlled substance schedules within their scope of practice to prescribe.

    • Obtain and maintain access to CURES.

  • Licensed nursing staff shall comply with this procedure including:

    • Proper use of an ADDS.

    • Proper disposition, storage, waste and return of CII-V controlled substances.

    • Proper use of a paper ICM as needed for CII-V controlled substances tracked outside of an ADDS and during ADDS downtime procedures.

    • Proper storage under double lock of patient-specific labeled prescriptions of CII-V controlled substances.

Procedure

• Institution DEA Registration

  • Required Registration

    • The PIC and CEO of each institution and the Regional Pharmacy Services Manager are responsible for keeping the correctional pharmacy’s DEA registration current and accurate.

      • CCHCS pharmacies must register with the DEA.  The registration must be maintained at the registered location and be available for inspection.

      • The CEO, or designee, shall be the certifying official, and the PIC shall be the registrant on the DEA registration certificate.  A separate DEA registration is required for each correctional pharmacy license.

      • Scanned copies of all DEA registrations and renewals shall be provided to the Statewide Chief of Pharmacy Services via e-mail at pharmacyreports@cdcr.ca.gov.

      • The PIC shall list their email address with the DEA as the institution contact.

      • The PIC and CEO are responsible for the timely renewal of the DEA registration which shall be completed online.

    • Where non-patient-specific CII-V controlled substances are to be stored at a licensed unit outside of an ADDS, the location shall possess its own DEA registration.  The CEO, in collaboration with the PIC, shall be responsible for keeping a licensed unit’s DEA registration current and accurate.

    • Renewal of the DEA registration is required every three years.  CDCR institutions are exempt from payment of the registration fees.  The registrant shall receive a renewal notice approximately 60 calendar days before the expiration date.

  • Additional Registrations for Substance Abuse Treatment and Detoxification

    • A clinic engaged in Schedule II substance abuse treatment and detoxification must obtain:

      • A separate DEA registration as a Narcotic Treatment Program (NTP) via a DEA Form 363 which may be completed online at the following link:  http://www.deadiversion.usdoj.gov/.

      • A completed Narcotic Treatment Program Initial Application (DHCS 5014) with the Department of Health Care Services.

      • Approval and certification by the Center for Substance Abuse Treatment within the SAMHSA (https://www.samhsa.gov/) of the U.S. Department of Health and Human Services as well as the applicable state methadone authority.

    • As of the date of this policy revision, CCHCS does not independently operate any NTPs.  All methadone treatment is provided by contractors, which must comply with NTP registration and certification requirements outlined in paragraph (d)(1)(B)1.  Should CCHCS elect to operate a NTP at some point in the future, it shall comply with these NTP registration and certification requirements.

• Training

  • All pharmacy staff shall complete the Controlled Substance Learning Management System Training upon hire and annually.

• Authority to Prescribe/Order Controlled Substances

  • Each provider must have their own DEA registration to prescribe/order controlled substances.

  • Only those providers registered with the DEA and authorized by their respective State of California licensing board shall prescribe/order controlled substances.  It is the provider’s responsibility to notify the CCHCS Credentials Verification Unit of any changes to their DEA registration.

  • For advanced practice providers to have authority to prescribe/order controlled substances, they must have a DEA registration, have met applicable State of California licensing board requirements, and prescribe/order within their scope of licensure.

  • All pharmacists have the responsibility to ensure that controlled substance prescriptions/orders have been issued by appropriately authorized providers. Additionally, pharmacists have a corresponding responsibility to ensure that controlled substance prescriptions/orders are issued for a legitimate medical purpose and dispensed in quantities that are consistent with the dose and frequency as ordered by the provider. Pharmacists are unable to dispense controlled substances without the provider bearing the prerequisite valid credentials.

• Prescription/Order Requirements for Controlled Substances

  • CII-V controlled substances, except those used in the treatment of substance use disorder and approved for KOP by the Systemwide P&T Committee, shall always be administered under Directly Therapy (DOT), following the techniques outlined in the HCDOM, Section 3.5.29, Medication Administration.

  • Duration of Controlled Substance Orders

    • Prescription orders that exceed the maximum duration may be changed by the pharmacist to be filled at the maximum allowable duration.  The pharmacist shall notify the ordering provider of any change to the prescription order.

    • All initial (new start) orders for CII-V controlled substances shall have a maximum duration of seven calendar days from the date written.

    • The patient shall be evaluated by the primary care team for any change in condition prior to placing an order for additional CII-V controlled substances.

    • Orders for stable CII controlled substances shall have a maximum duration of 30 calendar days and may be written or renewed up to seven calendar days in advance.

    • Taper orders for CII-V controlled substances may be written in their entirety up to and including discontinuation.

    • Hospice or palliative care orders for CII controlled substances shall have a maximum duration of 60 calendar days and may be written or renewed up to seven calendar days in advance.

    • Orders for stable CIII-V controlled substances shall have a maximum duration of 90 calendar days and may be written or renewed up to seven calendar days in advance.

  • Selection of Controlled Substance Medication

    • Orders for extended-release opioids must be preceded by a trial of an immediate-release formulation unless explicit rationale is given and documented in the health record for departure from this protocol.

  • Controlled Substance Prescriptions

    • For all controlled substances, the provider shall first enter the order via computerized provider order entry (CPOE) as soon as feasible, in addition to fulfilling the legal requirements established in federal and state laws.

    • All prescriptions/orders for controlled substances shall be signed utilizing the approved DEA-certified electronic prescription application unless electronic access is unavailable.

    • When electronic access is unavailable, DEA-permitted verbal and written prescriptions may be used. Pharmacists shall affirmatively opt out of the DEA-certified electronic prescription application at the time of verification of the order in the Electronic Health Record System (EHRS). DEA verbal and written prescriptions shall meet the following requirements:

      • DEA CII controlled substances

        • Pursuant to Code of Federal Regulations (CFR), Title 21, Part 1306, Section 1306.11(a), when a patient is given medication which is a DEA CII controlled substance for administration outside of the institution, it is incumbent on the pharmacist to procure from the prescriber a California-approved tamper-resistant prescription blank pursuant to HSC, Section 11162.1 of the California Uniform Controlled Substances Act before dispensing.

      • DEA CIII-V controlled substances

        • Pursuant to CFR, Title 21, Part 1306, Section 1306.21(a), a pharmacist may only directly dispense a CIII-V controlled substance pursuant to a paper prescription signed by a practitioner on a California-approved tamper-resistant prescription blank or a verbal prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec. 1306.05, except for the signature of the practitioner.

        • For verbal prescriptions, the provider shall subsequently call the pharmacy.  If the provider has yet to call a pharmacist to deliver the verbal prescription, it is incumbent on the pharmacist to contact the provider to obtain the verbal prescription with readback to ensure a timely dispense.

        • When accepting a verbal prescription, the pharmacist shall ensure that a verbal order with readback is obtained and reduced to writing. Documentation must include all elements as required by the DEA Controlled Substances Accountability Training Manual. The hard copy of this prescription shall be retained for at least three years.

    • The Chief Medical Executive at each institution shall be responsible for ensuring that California-approved tamper-resistant prescription blanks are procured and secured within the institution and available during correctional pharmacy business hours.

• Continuity of Controlled Substance Prescriptions/Orders

  • Continuity of CII Controlled Substance Prescriptions/Orders

    • Federal law does not permit the transfer of CII controlled substances prescriptions/orders between institutions; therefore, a new prescription/order is required for CII controlled substances prior to administration when a patient transfers from one institution to another.

    • When a patient transfers between CDCR institutions and has a current order for a CII controlled substance, the pharmacist conducting the transfer shall notify the provider or on-call provider for a controlled substance review.  The provider at the receiving institution shall be responsible for performing the controlled substance review.  If medication continuation is appropriate, the provider must enter a new order.

    • If the pharmacist cannot reach the provider, the pharmacist shall notify the receiving facility’s Receiving and Release (R&R) nursing staff via Message Center.

    • The R&R nurse shall contact the provider or on-call provider to complete the controlled substance review. If medication continuation is appropriate, the provider must enter a new order or provide the order to the nurse (telephone with readback for a maximum of 72 hours).

  • Continuity of CIII-V Controlled Substance Prescriptions/Orders

    • Prescriptions/orders for CIII-V controlled substances may only be transferred once as permitted by law and the prescriber’s authorization pursuant to CFR, Title 21, Chapter II, Part 1306, Section 1306.25, Transfer between Pharmacies of Prescription Information for Schedules III, IV, and V Controlled Substances for Refill Purposes.

• Emergency Telephone Orders for CII Controlled Substances

  • Pursuant to CFR, Title 21, Chapter II, Part 1306, Section 1306.11, Requirement of Prescription, telephone orders are only permitted in emergency situations as follows:

    • The immediate administration of the medication is necessary for proper treatment of the intended patient.

    • No alternative treatment is available (including medication which is not a CII controlled substance).

    • It is not possible for the prescribing provider to provide a written order for the medication at that time, because a provider is not on site.

  • Emergency telephone orders for CII controlled substances shall not be permitted if there is a provider on site at the institution with DEA CII controlled substance prescribing privileges.  When a provider is not on site, an emergency CII controlled substance telephone order may be given to a licensed nurse.

  • Emergency telephone CII controlled substance orders shall not exceed 72 hours in duration, and all orders must be signed or electronically authorized via CPOE by the provider within 48 hours or no later than the next business day following a weekend or holiday.

  • When the provider arrives onsite to sign an order or electronically authorize a CPOE order, a new order for continued therapy shall be written and signed or entered via CPOE when appropriate.

• Pharmacy Procurement, Accountability, and Disposal of Controlled Substances

  • Procurement

    • The PIC shall ensure that a pharmacist, who has the ability to order controlled substances to meet the needs of the institution, is on duty during correctional pharmacy hours.

    • All CII-V controlled substance purchases shall be made through contracted vendors.

    • The PIC, as the registrant, shall appoint pharmacists with Power of Attorney in sufficient number to ensure that the institution can order controlled substances needed for patient care. A sample Power of Attorney form is located in the CFR, Title 21, Chapter II, Drug Enforcement Administration, Department of Justice, Section 1305.05 (https://www.deaecom.gov/poa.html).

    • The PIC shall maintain current Power of Attorney forms in the correctional pharmacy’s Board of Pharmacy Compliance binder at all times.

    • Controlled substance invoices must be kept separately from other invoices and additionally split into a file for CII controlled substances and a file for CIII-V controlled substances.  Purchase records shall be retained for three years in accordance with federal and state regulations.

    • All CII controlled substances shall be procured from the vendor using preferably Controlled Substance Ordering System (CSOS) or, if unavailable, a DEA Form 222.

      • Procurement Using CSOS

        • Pharmacists who sign electronic orders to procure CII controlled substances shall enroll with the DEA to acquire their own personal CSOS certificate.

        • Each pharmacist with a CSOS certificate may procure CII controlled substances for the institution electronically via the CSOS program.

        • Each pharmacist shall be responsible for utilizing the CSOS program appropriately. 

        • When the “CII order” is received, a copy of the invoice shall be kept in the institution’s CII controlled substances procurement file.

      • Procurement Using DEA Form 222 (obtained by contacting the DEA)

        • When completing the single-sheet DEA Form 222 for procurement of CII controlled substances, the following shall be included:

          • The vendor’s name and address.

          • The vendor’s description of the drug being requested.

          • The number of packages and package size being requested for each drug.

          • The name and strength of each item being requested.

          • The total number of line items entered on DEA Form 222.

          • The registrant’s or agent’s printed name, signature, and date of DEA Form 222 completion.

        • The purchaser shall make and retain a copy of the DEA Form 222 and send the original to the supplier.

        • The purchaser should expect a two to three calendar day turnaround to receive the drug when using the paper process. The supplier shall record its DEA registration number and the number of packages shipped and report the transaction to the DEA.

        • When the order is received, the purchaser shall record the number of packages received for each item and the date the shipment was received on their copy of the DEA Form 222.

        • The DEA Form 222 and the corresponding invoice shall be stapled together and filed separately from other invoices in a CII controlled substances procurement file for auditing purposes.

      • The PIC, or pharmacist designee, is responsible for the receipt of the CII controlled substances.

        • When receiving the “CII order,” a pharmacist shall inspect the “CII order” to ensure the containers are sealed.  If the seal is broken, the PIC, or pharmacist designee, shall be notified immediately.  The PIC or pharmacist designee shall notify the vendor of the broken seal.

        • The pharmacist receiving the “CII order” shall check the “CII order” against the invoice and sign the invoice indicating the receipt and the date received.

  • Correctional Pharmacy Controlled Substances Inventory and Reconciliation

    • The PIC is responsible for maintaining all records pertaining to the acquisition and disposition of controlled substances.

    • A Perpetual Inventory Record (PIR) for each controlled substance shall be maintained in either paper or electronic form.

    • The PIC, or pharmacist designee, shall conduct periodic controlled substances inventory and reconciliation functions pursuant to federal and state laws, the HCDOM, Section 3.5.25, Inspecting Medication Storage Areas, and the DEA Controlled Substances Accountability Training Manual.

      • The PIC, or pharmacist designee, shall ensure that a pharmacist conducts a weekly physical count of all controlled substances that are located within the correctional pharmacy and a monthly inventory of all controlled substances contained within an ADDS operated by the correctional pharmacy. 

      • The PIC, or pharmacist designee, shall also conduct a monthly physical inventory of controlled substances in all medication storage areas of the institution where controlled substances are stored outside of an ADDS. 

      • The correctional pharmacy medication storage area inspection and the ADDS medication storage inspection shall include a count of all controlled substances and shall be documented on the appropriate CDCR 7477-A, Licensed Correctional Pharmacy Inspection Checklist, or CDCR 7477-C, Automated Drug Delivery System Medication Storage Inspection Checklist.

    • Inventory Reconciliation

      • Pursuant to CCR, Title 16, Division 17, Article 2, Section 1715.65, Inventory Activities and Inventory Reconciliation Reports of Controlled Substances, each correctional pharmacy and every licensed correctional clinic shall perform inventory activities and prepare inventory reconciliation reports to detect and prevent the loss of federal controlled substances at least once per quarter.

      • The PIC, or pharmacist designee, shall review all inventory activities performed and inventory reconciliation reports prepared, and shall establish and maintain secure methods to prevent losses of federal controlled substances.  For more information, refer to the frequently asked questions, which can be found at the following link: http://www.pharmacy.ca.gov/laws_regs/1715_65_inv_rec_rpt_faq.pdf.

      • Each inventory reconciliation report shall include all of the following:

        • A physical count, not an estimate, of all quantities of each federal controlled substance covered by the report that the pharmacy or clinic has in inventory. Where a physical count of an ADDS has been performed pursuant to the HCDOM Section 3.5.25, Inspecting Medication Storage Areas, less than 35 days prior to the inventory reconciliation, the PIC, or pharmacist designee, may utilize the count reported by the ADDS rather than a physical count for the reconciliation being performed. 

        • A review of all acquisitions and dispositions for each federal controlled substance covered by the report since the last inventory reconciliation report covering that controlled substance.

        • A calculation of expected count on hand which takes the end count from the prior report, adds all acquisitions and subtracts all dispositions.

        • A comparison between the actual count on hand and the expected count on hand to determine whether discrepancies exist.  Records for resolved discrepancies shall be maintained with the inventory reconciliation report.  Any remaining discrepancies shall be reported as a loss pursuant to CCR, Title 16, Division 17, Article 2, Section 1715.6, Reporting Drug Loss; the HCDOM Section 3.5.26, Break-In, Theft/Loss From Pharmacy or Medication Storage Areas; and the DEA Controlled Substances Accountability Training Manual.

        • This report and all  records used to compile the report shall be maintained in the pharmacy for three years in a readily retrievable form.

        • Identification of each individual involved in preparing the report.

        • Possible causes of overages.

      • In addition to the pharmacist conducting the reconciliation, the inventory reconciliation report shall be dated and signed by the PIC. Where the PIC conducted the reconciliation, the PIC shall sign indicating that they performed the reconciliation and that they reviewed the report.  An individual may use a digital or electronic signature or biometric identifier in lieu of a physical signature under this section if, in addition, the individual physically signs a printed statement confirming the accuracy of the inventory or report. The statement shall be dated and signed and retained on file for three years.

      • A new PIC of a correctional pharmacy shall complete an inventory reconciliation report for all federal controlled substances described within 30 calendar days of becoming the PIC; and whenever possible, an outgoing PIC shall complete an inventory reconciliation report for those controlled substances prior to their departure.

      • For each physical location which stores controlled substances, the PIC shall complete a separate inventory reconciliation report therefore maintaining separate reports for the correctional pharmacy as well as individual reports for each of the ADDS.

    • Annual Inventory

      • On the first business day of August each year, the PIC, or pharmacist designee, shall conduct an annual physical inventory of all controlled substances that are part of the correctional pharmacy inventory.  This includes controlled substances located within the correctional pharmacy and controlled substances contained within an ADDS operated by the correctional pharmacy.

      • The inventory for the correctional pharmacy shall be conducted at the beginning or end of the business day with the date and time noted on the inventory sheet.  The inventory for an ADDS shall likewise be noted with the date and time.

      • The inventory record shall be organized as follows:

        • Location (correctional pharmacy vs. each ADDS)

          • CII medications

          • CIII-V medications

        • Details for the controlled substances reconciliation by location

      • The annual inventory shall be conducted in August of each year, and the controlled substances reconciliation shall be considered the reconciliation for the quarter that contains August of each year.

      • If operational barriers exist to performing the annual physical inventory on the first business day of August, written permission from the Statewide Chief of Pharmacy Services, or designee, and regional pharmacy services manager, or designee, shall be obtained.  Written permission shall include a specified date by which the inventory shall be performed.

      • The most recent annual inventory conducted shall be used for the biennial inventory required by the DEA pursuant to the CFR, Title 21, Chapter II, Part 1304, Section 1304.11 Inventory Requirements. 

      • The inventory record must be signed and dated by the pharmacist conducting the inventory and by the PIC or pharmacist designee.

      • One copy of the physical inventory shall be maintained within the correctional pharmacy for audit purposes, and one copy shall be submitted via e-mail to pharmacyreports@cdcr.ca.gov.

    • Reporting Discrepancies

      • Any discrepancies shall be investigated by the PIC or pharmacist designee, and discrepancies that cannot be resolved shall be reported as detailed in the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

  • Tracking Movement of Controlled Substances

    • When a licensed unit has an ADDS supplied by the correctional pharmacy, controlled substances shall be stored in the ADDS to the extent possible.  Controlled substances not stored in the ADDS shall be provided with patient-specific labeling for individual patient administration.

    • A correctional pharmacy shall use electronic tools as directed by the Statewide Chief of Pharmacy Services, when available, to track all controlled substance transactions relating to the correctional pharmacy controlled substance supply.  Transactions tracked include, but are not limited to, the following:

      • Purchases received from wholesaler.

      • Returns sent to wholesaler or reverse distributor.

      • Stock transactions sent to ADDS.

      • Return transactions from ADDS.

      • Patient-specific dispenses or returns by the correctional pharmacy.

      • Patient-specific dispenses from a non-CDCR facility and its immediate destruction within the correctional pharmacy.

    • During downtime procedures, transactions shall be kept on a paper ICM.

    • Controlled substances which have become waste shall be disposed of pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff, and recorded electronically with a witness.

  • Disposal of Controlled Substances from the Correctional Pharmacy

    • Controlled substances removed from an ADDS that require disposal due to expiration date, spoilage, or contamination shall be returned to the correctional pharmacy.  These controlled substances shall be added to the controlled substances already stored in the correctional pharmacy for disposal.

    • The correctional pharmacy shall send expired medications to the contracted return vendor for potential credit and/or disposal pursuant to the contracted return vendor’s procedures.

      • The quantity of controlled substances to be sent to the contracted return vendor shall be deducted from the PIR and, when applicable, the pharmacy database.

      • Controlled substances for disposal that can no longer be used shall be segregated from active stock and inventory for this stock shall be maintained as part of the pharmacy’s destruction/return (PIR.  This inventory shall be inventoried at least weekly until they are sent to the contracted return vendor.  The PIC, or pharmacist designee, shall keep a destruction/return PIR for CII controlled substances and a separate destruction/return PIR for CIII-V controlled substances.  The PIC, or pharmacist designee, shall indicate on the destruction/return PIR the date the shipments were sent to the contracted return vendor and, if the shipment is a CII, the number on the DEA Form 222 provided by the contracted return vendor.

      • For CII controlled substances, the contracted return vendor shall provide the pharmacy with a DEA Form 222.  A pharmacist shall include the national drug codes, the quantity for each line item returned, and the date the shipment is physically sent to the contracted return vendor.  The pharmacy shall submit the DEA Form 222 to the DEA either by mail to the Registration Section or by email to DEA.Orderforms@usdoj.gov by the close of the month and retain the original copy in its CII file.

  • For guidance on the DEA process for movement of CII controlled substance inventory between CCHCS pharmacies, refer to the DEA Pharmacist’s Manual at the following link: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist’s_Manual_DEA.pdf

• Licensed Units Ordering, Receiving, and Administering Controlled Substances

  • Pursuant to the HCDOM, Section 3.5.3, Furnishing or Dispensing Medication to Legally Authorized Persons or Entities: Licensed Correctional Clinics, controlled substances within licensed units shall be handled as follows:

  • Licensed units are NOT permitted to have stock controlled substances without possessing a DEA registration.

  • In the absence of a DEA registration, controlled substances for use by the licensed units shall be:

    • Dispensed as patient specific by the correctional pharmacy pursuant to an order and shall bear a label restricting its use to the identified patient; or

    • Maintained within the licensed unit ADDS.  All controlled substances within an ADDS are considered a part of the correctional pharmacy and fall under its DEA registration.  Furnishing of controlled substances from an ADDS shall occur pursuant to the HCDOM, Section 3.5.4, Automated Drug Delivery System.

• Controlled Substances in an ADDS

  • Controlled substances shall only be stored in locking bins within an ADDS and shall be replenished by the correctional pharmacy during pharmacy business hours based upon electronic prompting.

  • The ICM shall be updated with the data input required prior to removal of controlled substances from the ADDS.

  • When controlled substances, for any reason, have not been administered to the patient for whom they were withdrawn and the medication remains usable for its intended purpose without being opened or crushed, the medication shall be returned to the ADDS electronic return bin.

  • When a dose of controlled substance removed from an ADDS is no longer usable for its intended purposes, the waste transaction shall be recorded at an ADDS.   The medication shall be disposed of pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.  Following which, the disposal shall be recorded by the nurse wasting the controlled substance and the witness at the ADDS.

  • At the beginning of every controlled substance withdrawal, the licensed nursing staff shall verify the count within the compartment of the ADDS.

    • If the count entered matches the ADDS expectation, then the withdrawal from the compartment occurs and the transaction is complete.

    • If the count entered does not match the ADDS expectation, then a discrepancy is created.  A discrepancy message shall be sent via e-mail to designated supervisory staff determined by the institution PIC and CNE.  The withdrawal transaction shall be permitted to occur; however, the discrepancy must be addressed as outlined below.

    • All discrepancies shall be addressed and either resolved or verbally reported to the SRN II or Unit Supervisor on duty on the shift in which they were created or found.  When the SRN II  or Unit Supervisor is unable to resolve a discrepancy, the discrepancy shall be handled in accordance with the HCDOM, Section 3.5.26, Break-in, Theft/Loss from Pharmacy or Medication Storage Areas.

  • Pharmacy staff shall conduct a physical inventory of all controlled substances in each ADDS no less than once every month.  When a discrepancy is discovered, a transaction history and a discrepancy report shall be generated.  Any discrepancies discovered during the physical inventory shall be reported to the SRN II or Unit Supervisor on duty.  When the pharmacy staff and SRN II or Unit Supervisor are unable to resolve a discrepancy, the discrepancy shall be handled pursuant to the HCDOM, Section 3.5.26, Break-in, Theft/Loss from Pharmacy or Medication Storage Areas.

• Controlled Substances Utilization, Review and Evaluation System

  • Pharmacy responsibilities under CURES

    • Pursuant to HSC, Division 10, Chapter 4, Article 1, Section 11165, Controlled Substance Utilization Review and Evaluation System: Establishment; Operation; Funding; Reporting to Department of Justice.

      • For each prescription for a CII-V controlled substance, unless legislatively exempt, the dispensing pharmacy shall report the specified information to the Department of Justice CURES Program as soon as reasonably possible but not more than one business day after the date a controlled substance is dispensed.  Orders written for patients admitted to CDCR institutions are exempt from this requirement until prescriptions are written for a patient leaving the institution such as for release.

      • It is a misdemeanor crime for any person not authorized by law to access the CURES database.

      • It is a misdemeanor crime for any person authorized by law to access the CURES database to knowingly furnish information from the CURES database to a person who is not authorized to receive that information.

    • A maximum of a 30-day supply of controlled substances is permitted pursuant to a valid prescription for the purposes of release or when used in the treatment of substance use disorder and approved for KOP by the Systemwide P&T Committee to be given directly to the patient.  Controlled substances shall be dispensed pursuant to a valid prescription under federal and state laws in accordance with the HCDOM, Section 3.5.20, Medication Continuity with Patient Movement: Transfer/Parole/Discharge/Re-Entry Program and reported to CURES within one business day.

    • CURES reporting occurs electronically.  Information regarding CURES reporting is available on the State of California Board of Pharmacy website

  • Prescriber responsibility under CURES

    • All providers authorized to prescribe controlled substances are required to have access to CURES and consult CURES pursuant to HSC, Division 10, Chapter 4, Article 1, Section 11165.4, CURES: Prescribers’ Duty Required to Consult CURES.

    • If the first time a provider prescribes a controlled substance to a patient occurs within 12 months of their incarceration, the provider shall consult CURES to review the patient’s history of controlled substances.

    • When prescribing a controlled substance for a patient upon release, the provider shall consult CURES.

    • More information regarding mandatory use of CURES for prescribers can be found at the following link: https://www.mbc.ca.gov/Resources/Medical-Resources/CURES/Mandatory-Use.aspx.

Policy

• California Correctional Health Care Services shall ensure that pharmacy policies and procedures (P&Ps) are reviewed and approved by all stakeholders and published in the Health Care Department Operations Manual (HCDOM).  Pharmacy P&Ps shall be implemented as written within California Department of Corrections and Rehabilitation (CDCR) and made readily available to health care staff.

Purpose

• To ensure that the pharmacy operates in accordance with the HCDOM; and that revisions and additions to the HCDOM, Chapter 3, Article 5, Pharmacy are made and approved, as needed.

Procedure

• Chapter 3, Article 5, Pharmacy and Medication Services and pharmacy-related sections of the HCDOM shall be reviewed and revised as follows:

  • The Statewide Chief of Pharmacy Services, or designee, shall initiate the biennial review to ensure the P&Ps reflect current federal and state laws and regulations, applicable accreditation requirements, and standards of pharmacy practice.  The review process shall be initiated at least six months, prior to the biennial due date.

  • The Statewide Chief of Pharmacy Services, or designee, shall initiate interim revisions and additions, as needed to update or improve pharmacy services.

  • Health care staff shall forward suggested changes via email to Pharmacyreports@cdcr.ca.gov for consideration by the Statewide Chief of Pharmacy Services or designee.

  • P&Ps involving therapeutics or relevant to other disciplines shall be presented to the Systemwide Pharmacy and Therapeutics Committee, and to the Systemwide Medication Management Subcommittee as appropriate.  Members of both committees shall obtain input from their corresponding disciplines (e.g., medical, dental, mental health, nursing, and pharmacy) on proposed changes to ensure they are not in conflict with any corresponding disciplines’ P&Ps.  Input shall also include operational perspective from frontline staff, which shall be shared with the rest of the committee members for consideration.

  • Once approved by the necessary committee(s), the Statewide Chief of Pharmacy Services, or designee, shall submit the P&Ps to the CCHCS Health Care Regulation and Policy Section, HCDOM Team, to route the P&Ps through the Clinical Policy and Procedure Review and Approval Process located on Lifeline at:
    RPS Clinical HCDOM Approval Process.pdf (sharepoint.com)

• Pharmacy P&Ps in the HCDOM, Chapter 3, Article 5 apply to all CDCR institutions and shall be implemented as published.  Institutions may establish local operating procedures (LOPs) to specify how they will implement statewide P&Ps.

• The Pharmacist-in-Charge (PIC) is responsible for ensuring that pharmacy staff have knowledge of and access to pharmacy P&Ps in the HCDOM and LOPs. The Statewide Chief of Pharmacy Services, or designee, is responsible for ensuring all headquarters and regional pharmacy staff have knowledge and access to pharmacy P&Ps in the HCDOM.

• If an institution has a licensed health care facility, the PIC shall ensure that a complete set of pharmacy P&Ps is reviewed and accepted through the institution Medication Management Subcommittee annually.

• Central Fill Pharmacy shall establish and maintain a set of LOPs relating to the repackaging process and central fill functions.

Procedure Overview

• Each pharmacy shall maintain a quality assurance program to document and assess pharmacy-related medication errors and shall adhere to the Health Care Department Operations Manual (HCDOM), Sections 1.2.6 and 1.2.7, Patient Safety Program; and Section 3.5.12, High Alert Medications.

Purpose

• To assess errors that occur in the pharmacy in dispensing or furnishing medications so the pharmacy may take appropriate action to prevent a recurrence.

Responsibility

• The Pharmacist-in-Charge (PIC) shall be responsible for maintaining a quality assurance program within the pharmacy to ensure that medication errors which are potentially attributable, in whole or in part, to the pharmacy or its personnel are assessed and addressed.

• The Statewide Patient Safety Program is responsible for providing the PIC with access to all medication errors reported through the electronic Health Care Incident Reporting system.

Procedure

• Pharmacy Medication Error Reporting

  • When a pharmacist determines that a medication error has occurred within the pharmacy which resulted in incorrect administration to the patient or self-administration by the patient or a clinically significant delay in therapy, the pharmacist shall do the following as soon as possible:

    • Ensure appropriate communication to the patient regarding the error that has occurred and the steps required to avoid injury or mitigate the error were provided.

    • Communicate to the prescriber and the appropriate nursing supervisor that a medication error has occurred.

  • Upon discovering any medication error, pharmacy staff shall report it as described in the HCDOM, Section 1.2.7, Institution Patient Safety Program.

• Pharmacy Process Improvement Activities

  • The PIC, or pharmacist designee, shall review any medication error(s) that have been determined to potentially have occurred due, in whole or in part, to pharmacy staff and commence the investigation using the CDCR Pharmacy Error Follow-up form on the electronic Health Care Incident Report (eHCIR) system as soon as reasonably possible but no later than  two business days of pharmacy staff discovering the medication error. 

  • The Statewide Chief of Pharmacy Services shall be notified of issues identified during error review that may affect statewide processes.

  • The PIC shall use findings from the pharmacy’s quality assurance program to develop and/or improve pharmacy systems and workflow processes to prevent future errors.

  • All errors reviewed by the pharmacy quality assurance program shall be shared with the appropriate institution quality committee (e.g., Medication Management Subcommittee, Patient Safety Committee, Quality Management Committee).

• Pharmacy Quality Assurance

  • Medication error reports are generated and maintained as a component of the pharmacy’s ongoing quality assurance program and are considered peer review documents not subject to discovery in any arbitration, civil, or other proceeding as provided under the California Business and Professions Code, Section 4125, and are therefore not part of the health record.

  • Pharmacy quality assurance review records shall be immediately retrievable in the pharmacy for a period of at least one year and shall be stored within the institution for at least three years from the date the record was created.

  • All quality assurance records, including medication error reports, involving an automated drug delivery system (ADDS) shall be filed separately from all other records pursuant to the timeframes in Section (d)(3)(B).  Any quality assurance record with an error attributable to an ADDS must also be submitted to the Board of Pharmacy within 30 days of completion of the quality assurance review.

Policy

• California Correctional Health Care Services (CCHCS) Systemwide Pharmacy and Therapeutics (P&T) Committee shall maintain a list of High Alert Medications and mitigation strategies to prevent patient harm when using High Alert Medications. The High Alert Medication List and mitigation strategies shall be disseminated to all health care staff, implemented when clinically appropriate at applicable institutions, and reviewed and updated at least annually.

Purpose

• To ensure the safe and effective use of High Alert Medications and the communication of the High Alert Medication List and mitigation strategies to all health care staff.

Responsibility

• Statewide

  • The Systemwide P&T Committee Chairperson shall ensure a High Alert Medication List and mitigation strategies are maintained and that appropriate tools, training, and technical assistance are available to all health care staff to support clinically appropriate use of the list.

• Regional

  • Regional Health Care Executives are responsible for implementation of this policy at the subset of institutions within an assigned region and shall ensure that the High Alert Medications policy, mitigation strategies, and other relevant decision support tools are disseminated and accessible for all health care staff.

• Institutional

  • The Chief Executive Officer is responsible for implementation of this policy at the institution level.  Program Leads shall ensure that the institution uses existing forums such as local quality committees to disseminate the High Alert Medications policy and procedure, mitigation strategies, and other relevant decision support tools to all institution health care staff.

Procedure

• The High Alert Medication List and mitigation strategies shall be reviewed and updated annually to provide guidance to health care staff about medications considered High Alert Medications and the appropriate handling of High Alert Medications to prevent patient harm.

• The High Alert Medication List and mitigation strategies shall be posted and available on the CCHCS Lifeline Patient Safety page.

• Data shall be drawn from the electronic Health Care Incident Reporting System including, but not limited to, medication related health care incidents, current medication usage across the health care system, industry best practices, and community standards and be reported to the Systemwide P&T Committee for consideration for addition to the High Alert Medication List.

• Decision support tools shall be revised or new tools developed to assist care teams and other health care staff in identifying and mitigating risks to patients associated with use of medications on the High Alert Medication List (e.g., High Alert Medication mitigation strategies, Patient Summary, Patient Registries, Patient Medication Profile, or Patient Risk Profile).

• Institution staff shall not alter the High Alert Medication List.

• Recommendation to add or remove a medication from the High Alert Medication List shall be submitted to PharmacyandTherapeuticsCommunications@cdcr.ca.gov.

Policy

• California Correctional Health Care Services (CCHCS) Systemwide Pharmacy and Therapeutics (P&T) Committee shall maintain a list of Heat Alert Medications to prevent patient harm when using Heat Alert Medications.  The Heat Alert Medication List shall be reviewed and updated annually and disseminated to all health care staff.

Purpose

• To ensure the safe and effective use of Heat Alert Medications and the communication and dissemination of the Heat Alert Medication List to all health care staff.

Responsibility

• Statewide

  • The Systemwide P&T Committee Chairperson shall ensure a Heat Alert Medication List is maintained, and that appropriate tools, training, and technical assistance are available to all health care staff to support clinically appropriate use of the list.

• Regional

  • Regional Health Care Executives are responsible for implementation of this policy at the subset of institutions within an assigned region and shall ensure that the Heat Alert Medications policy and other relevant decision support tools are disseminated and accessible to all health care staff.

• Institutional

  • The Chief Executive Officer and Warden are responsible for implementation of this policy at the institution level.  Program Leads shall ensure that the institution uses existing forums such as local quality committees to disseminate the Heat Alert Medications policy, procedure, and other relevant decision support tools to all institution health care staff.

Procedure Overview

• CCHCS and CDCR shall maintain a Heat Alert Medication List and take special precautions to prevent heat-related illness in patients prescribed medications that have the potential to impair thermoregulation.  These precautions are documented in a CDCR Heat Plan enforced from May 1 through October 31 each year and whenever temperatures warrant.

Procedure

• The Heat Alert Medication List shall be reviewed and updated annually to provide guidance to health care staff about medications considered Heat Alert Medications and the appropriate handling of Heat Alert Medications to prevent patient harm.

• The Heat Alert Medication List shall be posted and available on the CCHCS Lifeline Patient Safety.

• Data shall be drawn from the electronic Health Care Incident Reporting System including, but not limited to, Heat Alert Medication related health care incidents, current medication usage across the health care system, community standards, and be reported to the P&T Committee for consideration for addition to the High Alert Medication List.

• Heat Alert Medications are identifiable in existing CCHCS patient care tools, which may include the Electronic Health Record System.

• Decision support tools shall be revised, or new tools developed to help health care and custody staff identify patients who may be at risk of heat related illness (e.g., Heat Meds Custody Report, Heat Medications Registry, Patient Summary, Patient Medication Profile or Patient Risk Profile).

• Institution staff shall not alter the Heat Alert Medication List.

• Recommendations to add or remove a medication from the Heat Alert Medication List shall be submitted to PharmacyandTherapeuticsCommunications@cdcr.ca.gov.

• Heat Medication Reports

  • Designated health care and custody staff shall obtain a Heat Medication Report of all patients currently prescribed a Heat Alert Medication on a daily basis between May 1 and October 31 and whenever temperatures warrant.

    • The Heat Medication Report shall identify all patients on heat medications while their medication order is active and for a period of time after discontinuation.

    • The period of time that heat medication alerts continue after a medication has been discontinued shall be determined at the time of review of the Heat Alert Medication List. Any additions or deletions shall be made as appropriate based on available data including, but not limited to, clinical evidence and pharmaceutical parameters.

  • Care Teams and other appropriate health care staff shall monitor patients listed on the Heat Medications Registry to identify those who may require follow-up health care services or a change in drug therapy due to a heat alert.  This registry is available on the Quality Management Portal at the following link: https://qmtools.accounts.cdcr.ca.gov/Reports/report/QM/Tools/HeatMedications

  • Custody staff shall identify and locate all patients who are on the Heat Meds Custody Report during Heat Plan activation.  This report is available on the Quality Management Portal at the following link: https://qmtools.accounts.cdcr.ca.gov/Reports/report/QM/NonClinical/HeatMedicationsCustody

Procedure Overview

• This procedure applies to licensed inpatient beds only.  Beds licensed under California Code of Regulations, Title 22, have additional regulatory requirements that must be met which may include, but are not limited to the following:

• Automatic medication stop order dates (applies to all licensed beds).

• Drug Regimen Reviews (applies to Skilled Nursing Facilities [SNF] or where otherwise required by licensing or accreditation).

• Bedside medications (applies to all licensed beds).

Purpose

• To promote patient safety and comply with federal and state requirements for licensed inpatient beds.

Procedure

• Automatic Medication Stop Order Dates:

  • Medication orders for patients in licensed inpatient beds shall be automatically stopped after 48 hours if the duration is not specified in the order.

  • If the automatic stop date falls on a weekend or a holiday, this date shall be extended to the next regular business day unless otherwise specified by the prescriber in the original medication order.

  • Licensed health care staff shall ensure that all telephone orders for patients in licensed inpatient beds contain the required prescription elements including the duration of the order (Refer to the Health Care Department Operations Manual, Section 3.5.8, Prescription/Order Requirements and Medication Availability).

  • When pharmacy receives an order without a duration specified, the pharmacy staff shall contact the prescriber for clarification.

  • Pharmacy shall inform medical leadership of any concerns where medications have been automatically stopped due to a lack of clarification of the order duration.

• Drug Regimen Reviews

  • The Pharmacist-in-Charge shall ensure that drug regimen reviews are completed at the appropriate interval for patients admitted to licensed SNF beds or where otherwise required by licensing or accreditation.

  • A pharmacist shall review the drug regimen of each patient at least monthly and prepare appropriate reports.  The review shall include:

    • All medications currently ordered,

    • Information concerning the patient’s condition relating to drug therapy,

    • Medication administration records, and where appropriate,

    • Physician’s progress notes, nurse’s notes, and laboratory test results.

  • The pharmacist shall be responsible for reporting, in writing, irregularities in the dispensing and administration of medications and other matters relating to the review of the drug regimen to the administrator and Chief Nurse Executive (CNE).  A pharmacist shall evaluate:

    • Appropriateness of therapy (indication, route, frequency, dose, and duration).

    • Potential drug interactions.

    • Contraindications.

    • Therapeutic duplication and/or polypharmacy.

    • Unnecessary medications.

    • Documented allergy and adverse drug reactions.

    • Relevant lab results for abnormalities as required for drug monitoring.

    • Any other common parameters requiring adjustment in dose or regimen.

  • The pharmacist shall communicate the findings of the review in writing to the prescriber and the CNE or designee (e.g., the supervising nurse in charge of a licensed SNF).

  • The pharmacist shall make an entry in the progress notes indicating that the patient drug regimen has been reviewed, document any issues when identified, and sign and date the entry.

• Bedside Medications

  • Prescribed medications permitted to be allowed for bedside shall be limited to sublingual or inhalation forms as specified on the Rescue Medications list, which has been approved by the Systemwide Pharmacy and Therapeutics Committee.

  • Prior to prescribing any medication to be allowed at bedside, providers shall evaluate the patient’s mental and physical capacity to self-administer medication.

    • If the provider has any doubt about the patient’s mental capacity to self-administer medication, bedside medication shall not be ordered until mental health services has been consulted and rendered a recommendation.

    • If a patient is deemed unable to self-administer medication, bedside medication shall not be ordered. The barriers to self-administration shall be documented in the health record.

  • Nursing staff shall:

    • Instruct the patient on the proper use and storage of the medication and document in the health record.

    • Document the frequency of use since the last registered nurse assessment and the treatment response if the patient used the medication.

    • Ascertain the reason if the medication is used more or less than prescribed and, if appropriate, discuss with the patient the importance of adherence with prescribed use and document the variance in the health record.

    • Notify the provider if the patient has not used the medication according to the instructions or is not getting expected results.

    • Document in the electronic Medication Administration Record whenever a new supply of bedside medication is provided.

Procedure Overview

• The pharmacy shall be responsible for procuring, compounding (if authorized), receiving, dispensing, distributing, and storing pharmaceuticals used for treatment of patients in the institution.

Purpose

• To ensure a standardized method of procuring medications.

Procedure

• Medication Procuring and Receiving from Pharmaceutical Wholesalers or Manufacturers

  • All medications shall be ordered from the Central Fill Pharmacy, pharmaceutical prime vendor, or other state-contracted vendors when available. Exceptions to this policy must be pre-approved by the Chief of Pharmacy Services. All vendors shall be licensed with the California State Board of Pharmacy.

  • If medications are unavailable from the Central Fill Pharmacy or the pharmaceutical prime vendor, they may be purchased from another state-contracted vendor in accordance with applicable California Correctional Health Care Services procurement processes.  In this case, the Pharmacist-in-Charge (PIC) shall obtain a drug pedigree for medications ordered in accordance with federal and state regulations.

  • The PIC, or designee, shall maintain adequate stock of medications as follows:

    • By transmitting the order to the Central Fill Pharmacy, pharmaceutical prime vendor, or other state-contracted vendor.

    • Documenting ordered quantities.

    • Ensuring pharmacy staff inventories items received against the invoices upon order arrival and immediately resolves any discrepancies (e.g. missing or incorrect items).

    • Ensuring pharmacy staff notify the Food and Drug Administration using Form FDA 3911 and other trading partners within 24 hours if medication received was an illegitimate product or respond to a request for information within two business days in the event of a recall or to investigate a suspected or illegitimate product.

  • All medications shall be received by a pharmacist or other methods (e.g., the warehouse handles over-the-counter medications) acceptable by federal and state regulations.

  • A process shall be in place to ensure that responsible parties (e.g., analyst and support staff in other departments or institutions) mark goods received for timely payment to vendors.

  • Drug Enforcement Administration (DEA) controlled stock shall be received pursuant to the Health Care Department Operations Manual, Section 3.5.9, DEA Schedule II-V Controlled Substances.

• Medications Received from Contracted Pharmacies

  • Pedigrees for drugs dispensed patient-specific by CCHCS-contracted pharmacies are the responsibility of the dispensing pharmacy and need not be maintained at the CCHCS pharmacy location.

• Maintenance of Records

  • All invoices must be stored and maintained in accordance with federal and state regulations for three years.

• Pharmaceutical Supply & Inventory Control

  • The PIC, or designee, shall be responsible for the establishment and maintenance of a system for monitoring medication stock used in the facility.

  • A pharmacy inventory shall be performed annually in the last quarter of the fiscal year.

    • The inventory may be performed by the pharmaceutical prime vendor in accordance with the pharmaceutical prime vendor contract.

    • The annual inventory report shall be provided to the institution Medication Management Committee and the Chief of Pharmacy Services.

  • Inventories of controlled substances shall be performed pursuant to the Health Care Department Operations Manual, Section 3.5.9, DEA Schedule II-V Controlled Substances and the DEA Controlled Substances Accountability Training Manual.

• Use of Incarcerated Person Labor

  • Incarcerated persons shall not be allowed to handle or move any dangerous drugs as defined by Business and Professions Code, Division 2, Chapter 9, Article 2, Section 4022, or participate in any aspect of the pharmacy operation.

Procedure Overview

• Medications within California Correctional Health Care Services (CCHCS) and California Department of Corrections and Rehabilitation (CDCR) institutions shall be managed, labeled, packaged, and stored in compliance with applicable federal and state laws and regulations. Unusable medications shall not be stocked.

Purpose

• To ensure that medications within an institution are in compliance with applicable federal and state laws and regulations while being available, identifiable, and safe for use with proper labeling, packaging, and storage.

Responsibility

• Statewide

  • CCHCS and CDCR departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative, custodial, and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available so that licensed health care staff can successfully comply with this procedure.

• Regional

  • Regional Health Care Executives are responsible for compliance with this procedure at the subset of institutions within an assigned region.

• Institutional

  • The Chief Executive Officer (CEO) shall be responsible for the overall management and storage of medications within all health care service areas.

  • The Chief Support Executive (CSE) shall be responsible for ensuring the availability and proper maintenance (including, but not limited to, temperature monitoring) of medication storage areas and equipment in accordance with manufacturer recommendations and policy in all health care service areas.

  • The Pharmacist-in-Charge (PIC) shall be responsible for:

    • The management of medication inventory within the pharmacy and automated drug delivery system (ADDS).

    • The work completed by licensed pharmacy staff, assisting with medication inventory control and appropriate inventory storage in licensed non-pharmacy storage areas, e.g., licensed correctional clinic (LCC), Correctional Treatment Center (CTC), or Skilled Nursing Facility.

    • Fulfilling the role of Primary Vaccine Coordinator for the institution and managing vaccine inventory.

    • The dispensing or furnishing of medications in compliance with applicable federal and state laws and regulations inclusive of product labeling and patient prescription labeling.

    • Processing of shipments to the state-contracted reverse distributor.

    • Monthly inspections of medication storage areas.

  • The Chief Nurse Executive (CNE) shall be responsible for the management, accountability, administration, and issuance of medications in LCCs or other nursing patient-care areas.

  • The Supervising Dentist (SD) shall be responsible for the management, accountability, administration, and issuance of medications in dental LCCs.

  • The CEO, CSE, PIC, CNE, or SD, or their designees, are responsible for correcting identified medication management deficiencies within their respective health care service areas.

Procedure

• General Labeling Requirements

  • Prescription labels shall comply with the requirements in applicable federal and state laws, including California Code of Regulations (CCR), Title 16, Section 1707.5 and Business and Professions Code, Sections 4076, 4076.5 and 4076.6.

    • Chemical symbols shall not be used.

    • Latin abbreviations are not acceptable on Keep-on-Person (KOP) labels.

  • Patient-specific labels shall include the information listed below:

    • Name and address of the pharmacy dispensing the medication.

    • The date the prescription/order was issued (e.g., order transmission issue date).

    • The name of the patient (including the CDCR number).

    • The name of the provider.

    • Clear directions for use of the medication.

    • The name and the strength or dosage of the medication dispensed.

    • Liquid dosage forms shall include concentration as well as dosage.

    • The quantity of the medication dispensed.

    • The medication expiration date, not to exceed the pharmaceutical manufacturer’s expiration date in accordance with Section (d)(6), Beyond-Use Dates.

    • Administration type (e.g., KOP, NA, DOT, PAROLE).

    • Auxiliary labels as needed (e.g., precautionary labels).

    • Prescription number.

    • Pharmaceutical manufacturer.

    • Physical description of the product (e.g., tablet, capsule).

    • Medication prescription/order stop date.

    • The patient’s housing and bed location.

    • The condition or purpose for which the medication was prescribed if the condition or purpose is indicated on the prescription/order.

  • Non-legend (over-the-counter [OTC]) medications shall be labeled in conformance with federal and state laws, such as consumer-ready packaging, and do not require a prescription label from the pharmacy unless ordered as a prescription by a provider and dispensed by the pharmacy.

  • Only persons licensed to dispense medications may apply or modify a prescription label.  Persons licensed to dispense include, but are not limited to:

    • Providers authorized within the scope of their practice.

    • Pharmacists.

    • Registered Nurses working in an LCC pursuant to California Business and Professions Code, Division 2, Chapter 6, Article 2, Scope of Regulation, Section 2725.1.

  • It shall be the responsibility of the authorized prescriber to identify patients that require labeling or counseling in a language other than English and to identify the language required.

  • Where usable medications have been returned to stock, the pharmacy shall ensure any confidential patient information has been completely removed before a new label is placed.

• General Packaging Requirements

  • Medication Packaging

    • Medication containers must be provided that are consistent with CDCR Department Operations Manual, Section 54030.1, which specifies types of materials incarcerated persons may possess.  Medication containers that are acceptable for use when dispensing/furnishing medications include, but are not limited to:

    • Amber pharmacy vials with snap-on lids.

    • Plastic zip lock bags (amber or clear) with medications in unit-dose packaging.

    • Unit-of-use drug cards (blister pack and bubble pack).

    • Unit-dose.

    • Medication vials with child-proof packaging dispensed to patients for family visits, the Community Prisoner Mother Program, or release.

  • Central Fill Packaging

    • When feasible and if the medication is available through the Central Fill Pharmacy, filling should be processed through the Central Fill Pharmacy’s automated, high-volume dispensing equipment to ensure efficiency and to reduce waste.  Solid oral dosage forms provided by Central Fill Pharmacy shall be packaged in either blister cards containing quantities in increments of 30 or in unit-dose packaging.

  • Patient-specific Medication Quantity

    • Medication shall be issued in the quantity necessary to complete prescriptions/orders except as noted below:

    • Routinely administered medications limited to a 30-day supply per dispense.  Exceptions may be permitted as determined by the Systemwide Medication Management Committee.

    • Unit-of-use medications in multiples of package size may be dispensed utilizing the nearest manufacturer package size subject to the pharmacist’s judgment.

    • PRN (as needed) medications limited to a 30-day supply per dispense in multiples of 30 tablets or capsules (for oral dosage forms) shall be provided unless indicated otherwise in the prescription/order.

    • Prescriptions/orders for patients housed in CTCs or other inpatient areas, or in temporary locations may be dispensed in quantities less than a 30-day supply.

    • During downtime procedures, when prescriptions/orders are recorded on a CDC 7221, automatic stop prescriptions/orders applies to licensed inpatient beds only in accordance with the HCDOM, Section 3.5.14, Additional Requirements Pertaining to Licensed Inpatient Facilities.

• Storage Requirements and Inventory Management

  • General Requirements

    • Medications shall not be left exposed to the environment (i.e., out of containers or in containers with lids left off overnight) or left unsecured.

    • Breaches of security or losses shall be handled pursuant to HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

    • Containers shall be clean, intact, and closed securely.

    • Medication for internal use in liquid, tablet, capsule, or powder form shall be stored separately from medication for external use.

    • Test agents, germicides, disinfectants, and other household substances shall be stored separately from medication.

    • Each patient’s medications shall remain in the original package and with the labeling originally received from the pharmacy until the time of administration.

    • Floor stock medication, or non-patient specific medication excluding OTC medication in consumer-ready packaging used for nursing protocols and medication provided via an ADDS, shall only be maintained in licensed units (e.g., CTCs, skilled nursing facilities, hospices, and correctional clinics).

    • No outdated medications shall be stored with usable medications.

    • Every effort shall be made to keep the quantity and variety of medications maintained in inventory at a level to ensure appropriate availability but also to prevent waste and unsafe storage conditions.

    • The electronic health record system (EHRS) shall be used to order floor stock from a correctional pharmacy.  When EHRS is unavailable, all floor stock medications and supplies shall be ordered from the correctional pharmacy on a CDCR 7244, Drug Order.

    • Storing or consuming food and drink, chewing gum or tobacco, and applying cosmetics are prohibited in areas where medications are prepared or administered.

    • Food, drink, and laboratory specimens shall not be stored in the medication refrigerator/freezer.

  • Unusable Medications

    • Medications that no longer meet federal and state requirements are unusable and shall be removed from stock that is available for use.  Staff removing the medication from active inventory shall remove any confidential patient information from the packaging.  The medication shall be handled as follows:

      • Controlled substances waste shall be witnessed and documented and limited to contaminated and partial doses only. Complete doses dispensed from a CCHCS pharmacy and no longer necessary shall be returned to the pharmacy for appropriate re-dispensing. Patient-specific complete doses dispensed from a contracted pharmacy shall be wasted and documented at the clinic location. Expired medications shall be returned to the pharmacy for reverse distribution as defined in the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances.

      • All medication that has become outdated within the pharmacy shall be quarantined and disposed of as waste or shipped to the state-contracted reverse distributor pursuant to Section (d)(7) below.  All medication that has become outdated within a health care location shall be disposed of pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

      • All medications that are not Drug Enforcement Administration (DEA) scheduled controlled substances and are unusable shall be placed in the appropriate disposal container pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

      • Health care staff receiving medications returned by patients shall remove confidential patient information and immediately place in the appropriate disposal container pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

    • Medications dispensed in error including, but not limited to, the following reasons, shall be returned to the pharmacy:

      • The medication container has been filled with the wrong medication, dose, or quantity.

      • The container has been mislabeled (e.g., wrong administration method).

      • The medication is a duplicate order/issue.

    • Medications that are overstocked or considered of a quantity not needed for use in the health care setting shall be handled as follows:

      • DEA scheduled controlled substances dispensed from a CCHCS pharmacy shall be returned to the pharmacy for inspection, destruction, or redistribution as appropriate.

      • All other prescription or OTC medication may be returned to the pharmacy for redistribution or moved from one LCC to another LCC within the same institution pursuant to Business and Professions Code, Section 4187.

      • Health care staff shall make every effort to minimize the loss of medications due to outdating by attempting to locate other health care settings that may utilize this medication prior to becoming outdated.

      • Every medication storage area shall have a return bin for returning medications to the pharmacy.  Where a storage area has a medication refrigerator or freezer, there shall be a separate return bin for the refrigerator, the freezer, and room temperature medications.  Each return bin shall be clearly labeled “Pharmacy returns only; medication waste prohibited.”

  • Temperature Requirements

    • Medications that do not require refrigerated or frozen storage shall be stored at controlled room temperature.

      • Controlled room temperature is between 20°C and 25°C (68°-77°F); excursions permitted between 15° and 30° C (59°–86°F) (refer to United States Pharmacopeia [USP] Controlled Room Temperature).

    • Medications that require refrigerated, frozen or ultra-cold storage shall be stored as follows:

      • Refrigeration temperature shall be maintained between 2°C and 8°C (36°-46°F).

      • Freezer temperature shall be maintained between -50°C and -15°C (-58°-5°F).

      • Ultra-cold temperature shall be maintained at -90°C and -60°C (-130°-76°F).

    • The medication manufacturer recommendation for storage temperature shall be adhered to when different from above.

  • Temperature Monitoring

    • Room Temperature

      • All licensed medication storage locations shall have a thermometer to monitor room temperature.

      • Logging procedures shall be performed daily in all licensed areas where medications are stored (with or without an ADDS.  Additionally, any interruption in the functioning of an air-conditioned area or any area identified as possibly exceeding acceptable medication storage conditions shall require immediate corrective action (see Temperature Excursions, Section (d)(2)(E) below).

      • The room temperature shall be recorded at the beginning of the shift on the CDCR 7217, Medication Storage Temperature Log for each medication storage area staffed for third watch.  The room temperature shall be recorded at the end of the second watch shift for medication storage areas closed for third watch but open for second watch. The temperature log shall indicate the area as being “closed” for medication storage areas not staffed for either shift.

      • The room temperature shall be recorded on the CDCR 7217 at the time of the pharmacy closing (or in the early evening) to reflect the hottest temperature of the day for each pharmacy.  If closed for the day, the temperature log shall indicate the area as being “closed.”

      • Each completed temperature log shall remain in a designated location for pharmacy staff to review monthly. Once reviewed, pharmacy staff shall file the temperature logs in the designated location. Each institution shall determine a location for storing completed room temperature logs which shall be maintained for three years.

    • Refrigerator and Freezer

      • Temperatures shall be monitored with accurate thermometers twice daily during hours of operation.  In areas that are not open every day, the use of a DDL or the use of minimum/maximum thermometers shall be utilized.  The thermometer shall be checked as soon as the area re-opens. The temperature excursion process shall be followed if any out-of-range temperatures are shown to have occurred.

      • All refrigerated or freezer medication storage shall utilize a DDL or the CDCR 7217.  Each institution shall establish the following:

        • A process for storing completed logs which shall be maintained for three years.

        • A process to maintain and monitor equipment performance.

      • A DDL shall be used for any refrigerator or freezer storing vaccines. DDL are the preferred temperature recording method for all refrigerated, freezer, and ultra-cold medication storage.

      • When a DDL is used, CDCR 7217 is not required if the recorded temperature data is auditable electronically.

        • At a minimum, the data logger must be audited once daily and the minimum/maximum temperature shall be reviewed.

        • Data loggers with notification capability shall be pre-programmed to notify the area supervisor, or designee, in the event of a temperature excursion. The temperature excursion process shall be followed if any out-of-range temperatures are shown to have occurred.

        • At least once monthly during the medication room inspection, the monthly temperature log shall be reviewed for appropriate medication storage and temperature excursions.

  • Temperature Excursions

    • Room Temperature Excursions

      • Record the out-of-range temperature on the CDCR 7217.

      • Notify the supervisor and the PIC or onsite designee.

      • Document initial actions taken to correct temperature variance on the Temperature Excursion Action Record.  For example:

        • Alert the supervisor, PIC or onsite designee, of the out-of-range temperature.

        • Adjust the thermostat.

        • Notify Plant Operations that the medication storage area requires immediate attention.

      • If the temperature excursion is expected to exceed 24 hours, portable air conditioning units shall be made available.

      • In the event that portable air conditioning units are not available, a plan shall be immediately implemented to move medications to a secured air conditioned area during non-medication pass times.

      • Room temperature logging shall continue at least twice a day until the temperature excursion is resolved.

    • Refrigerator or Freezer Temperature Excursions

      • Record the out-of-range temperature on the CDCR 7217 or on the data logger software.

      • Alert the supervisor, PIC, or onsite designee, of the out-of-range temperature.

      • Take immediate actions to correct medication storage. These may include:

        • Temperature adjustment of the refrigeration unit.

        • Moving all medications to a functional refrigerator/freezer.

        • If vaccines are present, immediately implement emergency vaccine storage and handling process.

      • Notify CSE and Plant Operations as appropriate.

    • Emergency Vaccine Storage and Handling

      • Quarantine any vaccines in a separate container in the refrigerator or freezer with a “do not use vaccines” notice until pharmacy staff can retrieve or manufacturer guidance can be obtained, if:

        • The refrigerator temperature is warmer than 8°C (46°F).

        • The freezer temperature is warmer than -15°C (5°F).

        • The ultra-cold temperature is warmer than -60°C (-76°F).

• Pharmacy Security

  • Possession of a key or electronic access to the pharmacy where dangerous drugs and controlled substances are stored shall be restricted to a pharmacist.  Access to one additional pharmacy key for emergency purposes shall be maintained in a tamper evident manner pursuant to CCR, Title 16, Section 1714(e).

  • Each pharmacist, while on duty, shall be responsible for the security of the pharmacy including provisions for effective control against theft or diversion of medications.

  • A pharmacist shall be responsible for any individual who enters the pharmacy for the purposes of performing clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the pharmacy. The pharmacist shall remain present in the pharmacy during all times the authorized individual is present.  Temporary absences of the pharmacist are only permitted in accordance with the HCDOM, Section 3.5.27, Temporary Absence of the Pharmacist.

  • Institution locksmiths shall not access pharmacy locations without the presence and direct supervision of a pharmacist.

• Non-Pharmacy Medication Area Security

  • The CEO and CNE, or designee, shall ensure that medications stored in the nursing units, LCCs, or other nursing patient care areas are properly secured.  The CEO and SD, or designee, shall ensure that medications stored in the dental clinics are properly secured.

  • Doors to medication areas shall remain locked.

  • Medications shall be stored in locked rooms, cabinets, drawers, or carts of sufficient size in an orderly manner to prevent crowding.  Locked mobile medication storage (e.g., carts) shall be secured in a locked room when unattended.

  • Keys to the medication rooms, cabinets, drawers, or carts shall be restricted to licensed nursing, dental, and pharmacy staff who shall be personally accountable for them.

  • Keys shall not be left in drawers, hung on walls, given to patients, or given to non-medical personnel.

  • Institution locksmiths shall not access medication storage areas without the presence and direct supervision of health care staff.

  • Each institution shall establish a process for the transfer of keys (medication cabinets, drawers, carts, or medication rooms) among licensed nursing, dental, and pharmacy staff that precludes involvement of non-health care personnel.

  • Non-patient specific controlled substances shall be securely stored in an ADDS and must be under double lock in the medication areas at all times until withdrawn for administration.  The CNE shall be responsible for ensuring limited access, key control, and medication accountability for all controlled substances.

  • Patient-specific controlled substances (e.g., release medications or long-acting buprenorphine injectable) shall be stored under double lock.

  • Any unlicensed individuals in the medication area (e.g., housekeeping staff, patients being treated) shall be under the direct observation of licensed nursing, dental, or pharmacy staff.

  • Pharmacists shall conduct monthly inspections of medication storage areas in collaboration with licensed nursing or dental staff. A report of identified deficiencies shall be provided to the CEO and the CNE, SD, or Health Program Manager III as applicable.

• Beyond-Use Dates

  • Medications supplied in the manufacturer’s original packaging and stored appropriately shall be usable until the expiration date (considered to be midnight of the last day of the month indicated, unless otherwise stated) on the package unless otherwise stated in the Storage and Handling section of the Prescribing Information or the CCHCS Guideline for Calculating Beyond-Use Date.

  • Repackaged and dispensed medications shall comply with the Food and Drug Administration requirements and USP guidelines for determining beyond-use dates.

    • For non-sterile solid and liquid dosage forms that have been repackaged into single-unit and unit-dose containers, the beyond-use date shall be one year or less unless stability data or the manufacturer’s labeling indicates otherwise.

    • For all other types of non-sterile dosage forms, the beyond-use date is one year or the time remaining of the expiration date, whichever date arrives first unless otherwise stated in the CCHCS Guideline for Calculating Beyond-Use Date.

  • Any medication whose beyond-use date varies from the manufacturer’s expiration date shall be handled as follows:

    • A beyond-use date label shall be affixed on non-patient specific multi-dose and bulk medications.

    • Pharmacy shall communicate the beyond-use date to the appropriate staff.

    • The health care staff member that initially opens the container shall calculate the beyond-use date.  This date and the staff’s initials shall be written on the medication label or container.  No medication shall be used once it has reached the beyond-use date.

    • The health care staff that opens or needle-punctures a multi-dose vial shall identify the date 28 days from the present (or sooner if the manufacturer specifies differently) and write this beyond-use date and their initials on the label or vial.

    • All single dose injectables shall be discarded after their first opening, including sterile water for injection, regardless of remaining solution.

• Use of Master Contracts by Pharmacy for the Return of Medications

  • The PIC, or designee, shall supervise the disposition of outdated, discontinued, or overstocked medications within the pharmacy.

  • The pharmacy shall store outdated medications separate from active medication stock until disposition. The outdated medication storage area shall be clearly labeled.

  • The pharmacy shall utilize vendors contracted through master contracts for the destruction/credit of controlled and non-controlled substances and for the return/credit or destruction of medications that are unusable.

  • The pharmacy shall retain records of return, credit, and certificates of destruction documents for a period of three years.

• Medication Recalls

  • Recalled medications in licensed units (including, but not limited to, CTC, LCC, and ADDS) shall be returned to the pharmacy for disposition.

  • The pharmacy shall ensure that the recalled medication is unavailable for use and is either sent back to the manufacturer or destroyed per the recommendation of the manufacturer.

  • When a medication is recalled by the manufacturer, the PIC shall determine whether the recall has been extended to the pharmacy level or to the patient level.

    • Pharmacy Level:

      • If the recall is limited to the pharmacy level, the PIC, or designee, shall inspect all pharmacy and all patient care areas, including ADDS.  Medications affected by the recall shall be returned to the pharmacy for disposition.

      • The pharmacy shall maintain a record of pharmacy-level recalls.  This record shall be kept for a period of three years from the date of the recall.

    • Patient Level:

      • If the recall extends to the patient level, the PIC shall identify all patients who may be in possession of the recalled medication(s).

      • The PIC shall notify the CME, the CNE, prescriber, and nursing staff in patient care areas where medication may have been administered or distributed to patients.

      • Most medications stored in an ADDS were dispensed dose-by-dose and would have already been fully consumed.  For affected unit-of-use medications, the PIC shall notify the Chief CME, the CNE, prescriber, and nursing staff in patient care areas where medication may have been administered or distributed to patients.

      • The pharmacy shall coordinate with Nursing for retrieval and replacement of all medications affected by the recall.

      • The pharmacy shall maintain a record of patient-level recalls including a list of potentially affected patients and disposition.  This record shall be kept for a period of three years from the date of the recall.

Procedure Overview

• Hazardous drugs specified in the National Institute for Occupational Safety and Health List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (NIOSH List) shall be received, stored, prepared, dispensed, administered, and disposed of according to recommended practices to protect staff, patients, and the environment.  Parenteral hazardous drugs shall be administered only by persons trained in the safe use of such agents.  Sterile hazardous drugs shall only be compounded by pharmacies with appropriate licensure from the California State Board of Pharmacy.

Purpose

• To promote safety in handling of hazardous drugs, to reduce the risk of environmental or personal exposure, and to prevent exposure to hazardous drug waste.

Procedure

• Systemwide Handling of Hazardous Drugs

  • List of Hazardous Drugs

    • At least once every 12 months, California Correctional Health Care Services (CCHCS) shall review utilization within the organization and maintain a list of hazardous drugs that are used.  Hazardous drugs include medications specifically identified on the NIOSH List, medications that entered the market after the most recent version of the NIOSH List and likely meet its criteria for hazardous, and investigational drugs that would also meet the same criteria for hazardous.

  • Assessment of Risk

    • The United States Pharmacopeia (USP) General Chapter <800> standards shall be followed except where CCHCS determines that the exposure risk is minimal and a different containment strategy or work practice may be applicable, in which case, CCHCS shall complete an assessment of risk for the drug before deviating from the USP General Chapter <800> standards.  The assessment of risk includes, but is not limited to, consideration of the:

      • Type of hazardous drug (e.g., antineoplastic, non-antineoplastic, reproductive risk only)

      • Dosage form

      • Risk of exposure

      • Packaging

      • Manipulation

    • The assessment of risk includes alternative containment strategies or work practices proportional to the risk imposed on health care workers, patients, and the environment.
      

    • At least once every 12 months, the Systemwide Medication Management Subcommittee shall review and document the review of the assessment of risk.

  • Hazardous Drug Handling Areas

    • The Chief Executive Officer (CEO) at each institution shall ensure that signs are prominently displayed designating the hazard before entrances to any areas that may potentially handle hazardous drugs.  The pharmacist-in-charge (PIC) shall advise the CEO of areas where hazardous drugs may potentially be handled.

    • Only authorized personnel may access areas where hazardous drugs are handled.

    • Storing or consuming food, drink, chewing gum, or tobacco and applying cosmetics are prohibited in areas where hazardous drugs are prepared or administered.

  • All individuals handling hazardous drugs are responsible for understanding the fundamental practices and precautions and for continually evaluating these procedures and the quality of final hazardous drugs to prevent harm to patients, minimize exposure to personnel, and minimize contamination of the work and patient-care environment.

• Training

  • Health care staff shall complete training on handling hazardous drugs before independently handling the hazardous drugs and annually thereafter.  The breadth of the course may be limited to their job functions and shall conclude with an assessment to demonstrate and document competence.

• Personal Protective Equipment

  • Health care staff shall, at minimum, don personal protective equipment (PPE) according to procedures outlined in the sections below depending on the activity.  Each area supervisor shall make available chemotherapy gloves, gowns, eye/faceshields for any splash potential, and respirators for inhalation potential.

  • Health care staff shall not reuse disposable PPEs.  Reusable PPE shall be decontaminated and cleaned after use.

  • Chemotherapy gloves shall meet American Society for Testing and Materials standard D6978 or its successor and be powder-free.  Health care staff shall change gloves every 30 minutes (unless otherwise recommended by the manufacturer) or when the gloves are torn, punctured, or contaminated.

  • Gowns shall be disposable, be shown to resist permeability by hazardous drugs (e.g., polyethylene-coated polypropylene, other laminate materials), close in the back, be long-sleeved, have closed cuffs that are elastic or knit, and not have seams or closures that could allow hazardous drugs to pass through.  Health care staff shall change gowns every two to three hours (unless permeation information is specified otherwise by the manufacturer) or immediately after a spill or splash.

  • Goggles and faceshields shall be worn when there is a risk for spills or splashes.  Eye glasses or safety glasses with side shields alone are insufficient eye protection.

  • A fit-tested, NIOSH-certified N95 or more protective respirator shall be used for activities that require respiratory protection.  A full-facepiece, chemical cartridge-type respirator or powered air-purifying respirator  shall be used when there is a high risk of respiratory exposure (e.g., cleaning up a hazardous drug spill larger than what can be contained with a spill kit).

• Receiving and Storing Hazardous Drugs

  • A spill kit shall be available in areas receiving hazardous drugs.

  • A pair of chemotherapy gloves shall be readily available for use when unpacking hazardous drugs.

  • When receiving a shipment of hazardous drugs, the health care staff shall perform a visual examination of the shipping container for signs of damage or breakage before unpacking.

  • If a shipping container appears damaged, seal the container without opening it, and contact the supplier.

    • If it is to be returned to the supplier, enclose the package in an impervious container and label the outer container “hazardous.”

    • If it cannot be returned to the supplier, dispose of it as hazardous waste.

    • If the damaged shipping container must be opened, transport the shipping container in an impervious container to a Containment Primary Engineering Control and place it on a plastic-backed preparation mat.  Then, open the package to remove undamaged items to wipe with a disposable wipe.  Leave the damaged items in an impervious container, and label it “hazardous” to return to the supplier or to dispose of as hazardous waste.

    • A damaged shipping container shall be treated as a spill.  See section (c)(8) for reporting procedures.

• Preparing and Dispensing Hazardous Drugs

  • Manipulation of a hazardous drug or its active pharmaceutical ingredient within CCHCS for preparation purposes is prohibited.  CCHCS pharmacies are not equipped for sterile and non-sterile compounding of hazardous drugs.

  • Use of disposable/cleanable equipment (e.g., mortar, pestles, spatulas) shall be dedicated for use with hazardous drugs.

  • When possible, the pharmacy shall procure hazardous drugs in its final dosage form and in commercially packaged unit doses.

  • The pharmacy shall furnish all hazardous drugs of a topical, ophthalmic, or injectable dosage form in its original container to licensed units and to patients.  Hazardous drugs in oral solution or suspension formulations shall be furnished or dispensed in unit-dose packaging for Nurse Administered (NA) or Directly Observed Therapy (DOT) administration when feasible.

  • The pharmacy shall adhere a label (“Hazardous Drug” or “Hazardous”) identifying any NIOSH hazardous drug that is NA and DOT, or clinic stock.

  • Table 1 NIOSH drugs shall not be placed in automated counting or packaging machines.

  • When necessary, pharmacy staff shall count or repackage hazardous drugs donning the following PPE:

    • For a hazardous drug on the Table 1 NIOSH List, the pharmacy staff counting or repackaging shall wear at least two pairs of chemotherapy gloves and utilize a spatula to minimize contact.

      • If counting or repackaging an uncoated tablet, the pharmacy staff shall wear a gown and respirator in addition to the two pairs of chemotherapy gloves.

      • If pouring an oral solution or suspension into a smaller container, the pharmacy staff shall wear a gown and eye/faceshield in addition to the two pairs of chemotherapy gloves.

    • For a hazardous drug on the Table 2 NIOSH List, the pharmacy staff shall wear at least a single pair of chemotherapy gloves and utilize a spatula to minimize contact.

      • If counting or repackaging an uncoated tablet, the pharmacy staff shall wear an additional pair of chemotherapy gloves and a gown.

      • If pouring an oral solution or suspension into a smaller container, the pharmacy staff shall wear a gown and eye/faceshield in addition to a pair of chemotherapy gloves.

  • Any equipment that may have come into contact with the hazardous drug during the preparation or dispensing phase shall be decontaminated and cleaned after every use.

• Administering Hazardous Drugs

  • When administering hazardous drugs, licensed health care staff shall minimize exposure to the medication as much as feasible, assess the patient for risk of increased exposure (e.g., potential for spitting, vomiting), and don the PPE as specified at: https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Forms-%26-Medication-Lists/CCHCS-Hazardous-Drugs-PPE-Requirements.xlsx?web=1.

  • Unless clinically justified, hazardous drugs shall not be manipulated during the administration phase.

    • When a “crush/open and float” order is received by pharmacy, the pharmacist shall refer to both the CCHCS Statewide Pharmacy and Therapeutics Committee’s Mandatory Crush/Open List and the NIOSH List before authorizing such an order.

    • Where a “crush/open and float” order is received for a drug considered hazardous, the prescriber shall be contacted to determine whether the medication can be given intact.  If a “crush/open and float” instruction is considered essential, the nurse shall don additional PPE.

• Compounding Hazardous Drugs

  • Drugs shall only be drawn or compounded by a pharmacist or a pharmacy technician if the pharmacy has an active sterile compounding license with the California State Board of Pharmacy and meets the requirements of USP 797 and USP 800.
    

  • The PIC shall ensure that pharmacy staff engaged in the handling of parenteral hazardous drugs are properly trained and equipped to perform their duties.

• Accidental Contact and Spill Control

  • Any personnel who may be required to clean up a spill of hazardous drugs shall receive proper training in spill management and the use of PPE and NIOSH-certified respirators.  Spills shall be contained and cleaned immediately only by qualified personnel with appropriate PPE.  Qualified personnel shall be available at all times while hazardous drugs are being handled.

  • Spill kits and signs restricting access shall be readily available when hazardous drugs are administered.  All spill materials shall be disposed of as hazardous waste.

  • Personnel and non-pharmacy staff who are exposed during the spill or spill cleanup require immediate evaluation.  A health care incident report shall be completed, including the circumstances and management of the spill.  A copy of the incident report shall be forwarded to the institution’s Health and Safety Committee.

  • In the event of skin or eye contact with hazardous drugs, staff shall:

    • Wash any area of the skin that comes into contact with the medication thoroughly with soap and water.

    • Flush the eye(s) with copious amounts of water for at least 15 minutes while holding the eye lid(s) open.

    • Seek evaluation by a physician.

• NIOSH Hazardous Waste Disposal

  • Disposal of NIOSH hazardous drug waste, residual hazardous drugs, and supplies shall be consistent with waste container pursuant to the Health Care Department Operations Manual, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

• Hazardous Products Excluded from Use in the California Department of Corrections and Rehabilitation (CDCR)/CCHCS

  • Biohazardous drugs which are biologically active and potentially infectious to patients and staff will not be purchased or administered in CDCR/CCHCS (e.g., TICE® BCG for intra-vesicular injection [urinary bladder instillation]).  This exclusion does not apply to use of FDA-approved live attenuated vaccines (e.g., oral polio vaccine [OPV], varicella [chicken pox], measles, mumps and rubella [MMR combined vaccine], influenza [nasal spray], zoster [shingles], rotavirus, yellow fever [YF]).

Procedure Overview

• Repackaging and compounding of medications shall comply with applicable federal and state regulations.  All non-injectable compounded medications shall be considered nonformulary.  If compounded medications are needed, California Correctional Health Care Services (CCHCS) shall procure from a licensed compounding pharmacy whenever possible.  The Pharmacist-in-Charge is responsible for ensuring compliance with this policy and procedure.

Purpose

• To define methods for repackaging, labeling, and compounding medications.

Procedure

• Repackaging

  • Repackaging is governed by the Food, Drug, and Cosmetic Act and the United States Pharmacopeia (USP).

    • Central Pharmacy Services shall register and maintain licensure as a repackager under the Food and Drug Administration (FDA).  Central Pharmacy Services shall maintain a complete set of standard operating procedures consistent with current Good Manufacturing Practices.

    • Correctional pharmacies within the institution may conduct limited repackaging to service the licensed correctional clinics or licensed inpatient units within the institution without registering as a licensed repackager.  Refer to Section (c)(1)(C) below.

  • Repackaging by Central Pharmacy Services

    • Beyond-use dating from the Central Pharmacy Services repackager shall be (whichever is shorter):

    • Up to one year from the date packaged as determined by the repackaging materials utilized,

    • The manufacturer’s expiration date, or

    • The beyond-use date specified by the manufacturer once the product is opened.

  • Repackaging by a Correctional Pharmacy

    • Pharmacies shall comply with FDA guidance, which states that pharmacies may repackage drugs under the following conditions:

      • The facility is licensed by the state as a pharmacy.

      • The repackaging is done by or under the supervision of a licensed pharmacist.

      • The product is repackaged in a way that does not conflict with drug product labeling.

      • The repackaged drug product conforms to specific beyond-use dating.

      • The repackaged product is not sold or transferred by a pharmacy other than the one that repackaged the product.

    • Prior to starting the repackaging process, a pharmacist must check a sample label, verify the drug product, the beyond-use date, and review the batch control entry in the repackaging log.

    • Pharmacies shall comply with beyond-use dating requirements as set by the USP, which permits repackaged products to bear the shorter of the following dates:

      • Six months from the date packaged,

      • The manufacturer’s expiration date, or

      • The beyond-use date specified by the manufacturer once the product is opened.

  • Repackaging Logs

    • The repackaging logs for each repackaged medication shall include the following information:

      • Generic medication name

      • Trade medication name (if any)

      • Strength

      • Manufacturer

      • Manufacturer’s lot number

      • Manufacturer’s expiration date

      • Control or batch number (facility assigned)

      • Number of units repackaged (total doses repackaged and total packages created)

      • Date repackaged

      • Initials of the pharmacy staff repackaging

      • Initials of the pharmacist completing final check

    • The pharmacist shall check the repackaging logs for completeness and repackaged medications for expiration and beyond-use dates during monthly medication quality assurance rounds.

    • The repackaging logs must be retained for three years.

  • Labeling Repackaged Medications

    • Each label of the repackaged medication shall include:

    • Generic medication name

    • Most common trade medication name (if any)

    • Strength

    • Quantity in the package

    • Manufacturer

    • Control or batch number (facility assigned and unique for each batch of repackaged drug)

    • Date repackaged

    • Beyond-use date as outlined above in Section (c)(1)(C)2

    • Initials of the person repackaging

• Compounded Medications

  • CCHCS pharmacies are not currently equipped and licensed for compounding.  If compounded medications are needed, alternative methods of obtaining the product shall be sought.

  • For sterile compounded medications:

    • Whenever possible, closed systems (e.g., ADD-Vantage, Mini-Bag Plus) and commercially available products shall be dispensed by pharmacy to allow licensed health care staff to prepare at bedside as close to the administration time as possible.

    • If unavailable, the compounded medication may be ordered and prepared by a state-contracted sterile compounding vendor.

    • Refer to Health Care Department Operations Manual, Section 3.5.29, Medication Administration, for more details on administering intravenous therapy.

  • For non-sterile compounded medications:

    • Whenever possible, providers shall prescribe/order and pharmacies shall procure commercially available products that do not require combining ingredients or drugs.

    • If unavailable and with strong clinical justification provided, the compounded medication may be ordered and prepared by a state-contracted compounding vendor.

Procedure Overview

• California Correctional Health Care Services shall maintain a system to ensure that prescribers and other health care professionals are informed when prescribed medications cannot be provided in a timely manner because of inventory shortages, supply system shortages, or backorders.  The system shall include a process to allow prescribers to change therapy when appropriate and to notify health care professionals and patients of the change.

Purpose

• To ensure that prescribers have the opportunity to assess the impact on patient therapy and adjust the care plan in a timely fashion when medications are unavailable due to supply system interruptions.

Procedure

• When it is determined that a prescribed medication is unavailable from the supplier because of an inventory shortage, manufacturer shortage, backorder, or other reasons, the Pharmacist-in-Charge, or pharmacist designee, shall assess the anticipated duration of delay.

• The pharmacist shall communicate to the prescriber, or designee, and nursing staff when medication cannot be provided in the expected timeframe due to supply system interruptions.

  • The communication shall include an anticipated timeframe for obtaining the medication.

  • The prescriber shall determine the appropriate response and inform the pharmacist.  The provider shall prescribe an alternative medication or authorize a delay in medication delivery if the timeframe is safe and appropriate. The prescriber shall document the decision to prescribe an alternative medication or authorize a delay in the health record.

  • The pharmacist shall communicate the decision to nursing staff.

  • Nursing staff shall communicate the decision to the patient.

• The pharmacy shall keep a log of medications affected by the supplier interruption. Every business day, until the shortage resolves, the pharmacy shall reassess the availability of the prescribed medication and alternatives. A resolution for unavailable medications that are needed immediately or urgently shall be completed before the close of that business day.

• If medication becomes unavailable from the manufacturer for an indeterminate period of time, the Pharmacist-In-Charge shall notify the prescribers, nurses, institution Medication Management Subcommittee, and headquarters Pharmacy Services at cdcrcchcsrxsupplychain@cdcr.ca.gov.

• If the shortage is significant, the Statewide Chief of Pharmacy Services shall communicate the shortage to the Systemwide Pharmacy and Therapeutics (P&T) Committee.

  • The Systemwide P&T Committee shall determine if an alternative product can be established as a therapeutic substitute for the unavailable item(s) pursuant to Health Care Department Operations Manual, Section 3.5.6, Therapeutic Interchange and Automatic Substitution.

  • The recommendation for alternatives identified by the Systemwide P&T Committee shall be communicated to all facilities.

• Once the shortage resolves, the pharmacists shall communicate the availability of the medication to the prescriber to make changes as appropriate.

Procedure Overview

• This procedure provides guidelines for maintaining medication continuity with patient movement. This includes intrafacility transfers, interfacility transfers, transfers to outside facilities, and release.

Purpose

• To ensure continuity of drug therapy as patients transfer between California Department of Corrections and Rehabilitation (CDCR) facilities, to other law enforcement entities, or out-of-state correctional facilities and upon release from the jurisdiction of CDCR.

Responsibility

• The Chief Executive Officer and Warden of each institution have overall responsibility for adherence to this procedure while specific functional responsibilities are outlined below.

Procedure

• Transfer Procedure

  • Transfer Medication(s)

    • When a patient is cleared for transfer, continuity of medications shall be maintained.  

    • Pharmacy and Nursing shall provide all medications necessary to safely transport the patient. In the event that there is a medication missing that may compromise patient safety, staff shall coordinate with the Primary Care Team prior to transport. Best practice guidance on transfer medications shall be maintained and reviewed annually by the Systemwide Medication Management Committee and is available on Lifeline at: BestPractice_TransferMeds.pdf (sharepoint.com).

    • Medications which shall not be packaged for transfer include:

      • Non-patient-specific medications from a licensed correctional clinic (LCC) to a different institution which are included on the Standardized LCC Inventory list.

      • Non-patient-specific medications from an automated drug delivery system (ADDS).

      • Drug Enforcement Administration (DEA) controlled substances. If a transfer supply of a DEA controlled substance is needed:

        • For the pharmacy to dispense a DEA Schedule II controlled substance, the provider is required to enter an order in the Electronic Health Record System (EHRS) which will be automatically routed to the DEA-certified electronic prescription application for approval and signature. Alternatively, the provider may write an order on a California-approved, tamper-resistant prescription blank.

        • For the pharmacy to dispense DEA Schedule III-V controlled substances, the provider is required to enter an order in the EHRS which will be automatically routed to the DEA-certified electronic prescription application. Alternatively, the provider may write an order on a California-approved, tamper-resistant prescription blank or deliver a verbal order for the pharmacist to reduce to writing as pursuant to the Health Care Department Operations Manual (HCDOM), Section 3.5.9, DEA Schedule II-V Controlled Substances.

    • Medications packaged for transfer shall include:

      • Medications that have been issued for a specific patient. These medications may be ordered as Nurse Administered (NA), Directly Observed Therapy (DOT), or Keep-on-Person (KOP).  KOP medications shall be packed separate from the patient’s property prior to transfer.

      • Prescribed rescue medications as specified on the Rescue Medications list shall be kept on the patient’s person during transport. Prescribed naloxone or naloxone kept as personal property may be kept on the patient’s person during transport.  For patients who pose a security risk if allowed to carry medications during transportation, alternate methods may be used to transport the medication while allowing the patient access to it.

      • Medications unlikely to be available (e.g., specialty medications) at the receiving institution. The pharmacy shall dispense a patient-specific supply of such medications for transfer as needed to ensure at least a five-day supply is available for continuity of care.

      • A verbal and/or written report provided by the sending care team for patients needing high-risk medications, complex care, or special handling (e.g., narcotic treatment program [NTP] clinic availability for patients on methadone for substance use disorder [SUD], anti-hemophilia factors) pursuant to the HCDOM, Section 3.1.9, Health Care Transfer.

    • The Chief Medical Executive and the Pharmacist-in-Charge (PIC), or designees, at the receiving institution shall ensure that all active medication orders and medications are available for arriving patients. If the PIC at the receiving institution requires prescription or administration information beyond that which is provided by the sending institution, the PIC shall take action to make medications available including, but not limited to, the following:

      • Clarification from the health record.

      • Obtaining a new medication order.

    • In situations where medications are not available locally, the prescriber or on-call provider shall be contacted for orders to address clinical needs until the pharmacy can provide the required medications pursuant to the HCDOM, Section 3.5.8, Prescription/Order Requirements and Medication Availability.

  • Intra-facility Transfer of Medication (Patient Movement within the Institution)

    • Should a change in a patient’s bed assignment cause the patient to receive medications from a different medication administration location, the following procedure shall be followed:

    • Custody staff shall print out the Pending Bed Assignments (IPTR149) report from the Strategic Offender Management System prior to moving the patient and provide a copy of the report to licensed nursing staff. 

    • Licensed nursing staff shall check the patient on the report against the current Medication Administration Record to determine the need to have patient-specific medications relocated with the patient.

      • Licensed nursing staff shall note the number of KOP medications the patient should carry to the new housing assignment and sign the front of the report to indicate it has been reviewed.

      • Licensed nursing staff shall release the medications and the signed report in a labeled, sealed container to the custody officer to deliver to licensed nursing staff at the receiving medication administration location. The transporting custody officer shall ensure the patient’s KOP medications are documented for the bed assignment change. Under no circumstances shall KOP medications be packed with a patient’s property.

    • The custody officer shall transport the signed report and all medications provided by licensed nursing staff to the receiving medication administration location.

      • The licensed nursing staff at the receiving medication administration location shall check their LCC stock to ensure that non-patient-specific NA or DOT medications are available. If not available, Pharmacy staff shall be notified during business hours to stock the LCC (e.g., medication line). If it is after business hours, refer to the HCDOM, Section 3.5.24, After-Hours Pharmacy Services.

      • The custody officer shall notify a nursing supervisor and custody sergeant of barriers to following this procedure.

  • Inter-facility Transfer of Medication (Patient Movement between Institutions)

    • The Classification and Parole Representative (C&PR), or designee, shall provide a transfer list to designated institution health care staff at the sending institution no later than Thursday regarding any patients scheduled for transfer the following week. Any modifications to the transfer list shall be properly communicated by the C&PR office to the designated institution health care staff at the sending institution.

    • Pharmacy staff at the sending institution shall review the transfer list for patients who are on specialty medications or medications not generally stocked by all CDCR pharmacies.

      • The PIC, or designee, at the sending institution shall:

        • Contact the pharmacy at the receiving institution when a transferring patient is identified as receiving specialty or medications not generally stocked.

        • Inform the receiving institution what medications these patients require, how that medication shall be ordered/provided, and determine whether medication(s) need to be shipped to the receiving pharmacy by the sending pharmacy.

      • When medications need to be shipped to the receiving pharmacy, the sending pharmacy shall send the medication via the contracted overnight package vendor with tracking information shared with the receiving pharmacy.

    • In the event that a patient-specific NA or DOT medication order is expiring within five days of transfer, a pharmacist shall notify the provider to renew the order to ensure medication continuity. Medication shall be provided according to established dispensing procedures.

    • The Receiving and Release (R&R)/Transfer Registered Nurse (RN) shall complete the Interfacility Transfer PowerForm pending the anticipated transfer.

    • The custody officer shall ensure that transferring patients do not pack KOP medications in their property prior to transport. Once the custody officer has verified that the patient has all KOP medications outside of the property, the patient shall bring those medications to R&R.

    • Prior to transport, nursing staff shall:

      • Gather any patient-specific NA or DOT medications and place into the transfer envelope. If there is less than a five-day supply remaining, or if the medication is not on the Standardized LCC Inventory list, the pharmacy shall dispense a five-day transfer supply to deliver to R&R nurses.

      • Verify availability of an NTP clinic at the scheduled receiving institution for patients on methadone for SUD.

      • Document their actions in the Pre-Boarding Transfer Screening PowerForm.

      • In the event that the pharmacy is closed and a patient must transfer without a five-day supply of medications (e.g., to a higher level of care), coordinate with the receiving institution to ensure no lapse in medication administration occurs.

    • On the day of transport, the first watch Triage and Treatment Area RN/Transfer RN or R&R RN shall:

      • Administer all medications due to be given after the patient is moved from housing to R&R from the transfer envelope.

      • Administer the next scheduled dose of any unavailable patient-specific NA or DOT medication with clinic or ADDS stock as necessary and provide a verbal and/or written report to the receiving institution regarding missing medications. Refer to the HCDOM, Section 3.1.9, Health Care Transfer.

      • Contact the Primary Care Provider or on-call provider for direction if any high-risk medications (e.g., medications for transplant, chemotherapy, etc.) are missing on the day of transfer, and may place a temporary medical hold. Under no circumstance shall non-patient-specific stock from the clinic or ADDS be placed in the transfer envelope.

      • Ensure patients have self-administered KOP medications prior to placing the KOP medications in the transfer envelope.

        • In the event that KOP medications are not accounted for (i.e., a patient did not bring their KOPs), custody shall search the patient’s housing unit or property for KOPs.

        • If none are found, the nurse shall provide a verbal and/or written report to the receiving institution regarding the missing medications. Refer to the HCDOM, Section 3.1.9, Health Care Transfer.

      • Document the above actions in the Pre-Boarding Transfer Screening PowerForm.

      • Seal the transfer envelopes once all scheduled medication doses are administered to the transferring patients.

      • Give the envelopes to the R&R custody staff to seal the transfer envelopes within the transport container. Medications shall be packed and transported in the same vehicle as the patient and shall be made immediately available to the nurse at the layover or receiving institution(s) upon the patient’s arrival.

    • At the receiving institution, licensed nursing staff shall:

      • Return prescribed KOP medication to the patient for self-administration.

      • Document the medication administration in the KOP section of the Initial Health Care Screening PowerForm.

      • Request refill any KOP medications that did not arrive in the patient’s envelope following the usual pharmacy medication request process. 

      • Confiscate and appropriately dispose of any medication no longer in the original container, which cannot be identified, pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

      • Check the EHRS for an open patient encounter at the receiving institution, and follow the transfer process in the EHRS Workflow 500-40 Integrated Medication History, to ensure that medication orders are reconciled into the open encounter to allow for timely administration of NA or DOT orders and pharmacy dispensing of KOP medications where needed.

      • Administer any medications necessary from the transfer supply provided by the sending institution or from an ADDS or LCC within the institution. Refer to the HCDOM, Section 3.5.8, Prescription/Order Requirements and Medication Availability, Section (e)(13) for more information.

      • Contact a provider for medications with additional prescribing requirements, when necessary.  The provider shall issue a bridge order to ensure continuity of care. Patients requiring NTP services shall have a medical hold and an order for consult at an NTP within four calendar days.

  • Transfers to Non-CDCR Facilities including Hospital Visits

    • Licensed nursing staff from the sending institution shall collect the patient-specific NA or DOT medications and return them to the pharmacy.

    • When the patient is admitted to an outside facility and custody staff has retrieved KOP medications from a patient’s assigned housing unit, custody staff shall ensure delivery to health care staff for appropriate pharmaceutical waste disposal pursuant to HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

    • Under no circumstances shall KOP medications be packed with a patient’s property.

    • A verbal and/or written report with any specific high-risk medication information shall be provided to the outside facility pursuant to HCDOM, Section 3.1.9, Health Care Transfer. This shall include the licensed health care staff coordinating continuity of care for medications that cannot be dispensed to the patient (e.g., Medication Assisted Treatment [MAT], oncology infusions, long-acting injectable antipsychotics).

    • On rare occasions when the outside facility cannot provide specific medications, refer to the established best practice guidance available on Lifeline at:  CCHCS-Admitted-to-Non-CDCR-Facilities.pdf (sharepoint.com).

  • Transfers to Non-CDCR Facilities including Out-to-Court

    • CDCR shall provide medications for continuity of care if requested by the receiving law enforcement jurisdiction.

• Release: Parole/Probation/Discharge/Re-Entry Program

  • Pre-Release Planning

    • To assist the patient with continuity of medications after release (e.g., MAT, infusions, long-acting injectable antipsychotics), the licensed nursing staff shall connect the patient with external clinics based on the patient’s medical needs and expected relocation.

  • Release Medications

    • Prescription medications shall be prescribed and dispensed at the time of release to patients leaving directly from a CDCR institution or community correctional facility to a re-entry program or to the community through parole, probation, or discharge. 

    • Providers shall prescribe a 60-day supply of authorized medications for the purpose of continuity of care; refer to Section (d)(2)(C) for details.

    • The patient shall also be provided with a list of the medications and be advised to retain the copy for their provider in the community to reference. A pharmacist can also be reached at the toll-free number listed in the consultation flyer for a replacement copy or for questions related to their medication record; refer to Section (d)(2)(F).

    • The pharmacy shall:

      • Prepare a supply of prescribed legend medication(s), prescribed as needed (PRN) medications which pharmacy has dispensed in the last 30 days, and medications necessary to protect life, prevent significant illness or disability, alleviate severe pain, or mitigate side effects of other essential medications, unless clinically contraindicated, pursuant to an appropriately licensed provider’s order. Each institution shall ensure that the patient receives their medication(s) at the time of release with a list of the medication(s) provided.

      • Provide CDCR patients up to a 60-day supply of authorized medications (if within the confines of legal, clinical, and safe practices) when released from a CDCR institution or community correctional facility.

      • Provide PRN medications, not to exceed 50 percent of a 60-day supply.

      • Furnish an opioid reversal agent at the time of release.

      • Furnish condoms at the time of release.

      • Provide the medications to the receiving institution in cases of courtesy parole, where the patient transfers to an institution more convenient to their community.   

      • Be limited to the same rules set forth in policies and procedures, guidelines, and laws regarding medications with dispensing restrictions (e.g., DEA controlled substances, medications under a Risk Evaluation and Mitigation Strategy program).

    • Patients to be released to an inpatient facility outside of CDCR’s administrative authority (e.g., those under authority of the Department of State Hospitals) shall not be provided a supply of medications authorized by CDCR upon transfer. The sending institution shall provide a list of the patient’s currently prescribed medications for the receiving inpatient facility to order, fill, and dispense as appropriate.

    • Methadone for SUD treatment shall be administered within an NTP clinic. Prior to release, nursing shall provide a warm handoff of the patient to the NTP clinic, which the patient will be consulting upon release to mitigate any disruption in continuity of care upon release.

    • Health care and pharmacy staff shall be notified by the C&PR office at least seven days prior to a patient scheduled release date when possible. 

    • C&PR and/or staff shall promptly communicate to the pharmacy any additions or deletions made to the release list after it is sent to health care and pharmacy staff.

  • Authorized Medications

    • Authorized medications are those necessary to protect life, prevent significant illness or disability, alleviate severe pain, or mitigate side effects of other essential medications. This includes medications prescribed to treat chronic or acute illness which are scheduled to be taken on a routine or PRN basis and may occasionally include prescribed over-the-counter (OTC) medications.

    • Examples of prescribed OTC medications which may be provided include, but are not limited to:

      • Aspirin 81 mg

      • Proton pump inhibitors

      • Histamine-2 receptor antagonists

    • Medications that shall NOT be provided include:

      • OTC medications for minor ailments such as seasonal allergies, dandruff, and acne.

      • Items such as shampoos, moisturizing lotions, antacids, and sunscreen.

    • Exceptions to a full 60-day supply of medications are available on Lifeline and the CCHCS/CDCR publicly-accessible website.

  • Prescription Requirements

    • Release medications shall be prescribed via computerized provider order entry or, if unavailable, utilizing the CDC 7221, Physician’s Orders.  Refer to the HCDOM, Section 3.5.8, Prescription/Order Requirements and Medication Availability, for the required elements of a prescription.

    • An electronic prescription from the DEA-certified electronic prescription application or a completed and signed California approved tamper-resistant prescription shall accompany any order for a DEA Schedule II controlled substance as required by state law. Refer to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, for additional requirements for DEA Schedule II, III, IV, or V controlled substances.

      • All prescriptions for DEA controlled substances for patients being released are considered outpatient prescriptions and require the individual DEA number of the prescribing provider. 

      • Reporting to the Controlled Substance Utilization, Review and Evaluation System shall be completed electronically as required by the State of California Department of Justice.

    • Syringes and needles necessary for prescribed chronic subcutaneous medications shall be prescribed and dispensed in the same manner as medications. A licensed health care staff member performing within their scope of practice shall instruct the patient on the use of syringes.

    • Intramuscular injections, with the exception of auto-injectors and where patients have been trained to self-administer, shall not be dispensed.

    • Long-acting injectable psychotropic medications shall not be dispensed. The patient shall receive an injection just prior to release if deemed appropriate by the prescribing psychiatrist.

    • Intravenous medications shall not be dispensed.

  • Packaging and Labeling

    • All parole and discharge prescriptions for oral medications shall be dispensed in containers with secure child-resistant closures that protect medication from contamination, moisture, and light (e.g., plastic amber medication vials), with the exceptions of those exempted from Code of Federal Regulations, Chapter II, Subchapter E, Part 1700, Section 1700.14(a)(10) (e.g., birth control, sublingual nitroglycerin).

    • Medication shall be dispensed and placed in a stapled or sealed opaque bag by pharmacy staff with the patient’s name affixed. Medication shall be delivered to the nursing supervisor, or designee, prior to the day of release.

    • During the processing of release medications, three extra prescription labels for each medication shall be printed:

      • A label shall be affixed to each of the three copies of the CDCR 7533, Patient Release Medication Receipt.

      • The three copies of the CDCR 7533 shall be attached to the package containing the medication.

    • When a patient reports to R&R for release, all medication in their possession shall be confiscated and disposed of in accordance with the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff. Medications packaged for use within CDCR are not packaged in child resistant containers and therefore do not meet federal and state regulations for use outside of a CDCR facility.

    • At the time of release, health care staff shall scan the medication delivered to the patient in the health care record and have the patient sign two of the three copies of the CDCR 7533 to acknowledge receipt or refusal of the medication.

      • One signed copy of the CDCR 7533 shall be returned to the Health Records Department to be scanned to the health record.

      • The second signed copy of the CDCR 7533 shall be returned to Pharmacy to be saved for pharmacy records.

      • The third copy is given to the patient at the time of release.

    • If release medications are refused or not delivered to the patient for any reason, the medication shall be returned to the pharmacy before the end of the pharmacy’s business day with the CDCR 7533 indicating refusal or the reason for its return (e.g., release date changed).

      • If the patient’s release date is postponed to a time within five calendar days of the original planned release date, the pharmacist shall update its release list and re-issue the same medications to R&R.

      • If the patient’s release date is postponed beyond five calendar days of the original planned release date, the pharmacist shall void-cancel-credit the dispense and, if a DEA controlled substance, return the medication to the Controlled Substances Manager using the “return to stock of patient-specific dispense” function.

    • Missing or non-delivered medication shall be immediately reported (and documented) to the PIC and Supervising RN on duty for resolution prior to the patient’s release from the institution.

    • If release medications are not delivered to the patient at the time of discharge for any reason, all efforts shall be made by nursing, pharmacy, and custody staff to ensure delivery of medication to the patient.

      • To ensure continuity of care if medications are not sent with the patient upon release, staff shall follow best practice guidance available on Lifeline at: BestPractice_PBM.pdf (sharepoint.com).

  • Consultation

    • Patient consultation shall be made available in accordance with federal and state statutory and regulatory requirements. Included with each bag containing patient medication for release, the pharmacy shall include:

      • A patient drug information leaflet (also known as discharge information) for each medication supplied. Note: discharge information can be found in all required languages using the state-supplied drug information service.

      • A patient consultation flyer which shall contain:

        • Notification that drug information has been included.

        • Instructions to the patient specifying the phone number where a pharmacist can be reached during regular business hours and a list of the business hours the pharmacist is available. Central Pharmacy Services shall be available six days a week and no less than 40 hours per week.

    • The pharmacist checking the release packet shall document that the discharge information has been provided to the patient on the CDCR 7533.

Procedure Overview

• Emergency medications necessary for life support shall be available in emergency medication storage units (treatment carts, drawers, or cabinets). Only emergency medications as approved by the California Correctional Health Care Services Systemwide Pharmacy and Therapeutics (P&T) Committee shall be stocked in treatment carts.  Treatment carts shall be secured in Triage and Treatment Areas (TTAs) or, if permitted by the institution Emergency Medical Response Review Committee (EMRRC), designated licensed units. Pharmacists shall inspect the emergency medication storage units during monthly medication area inspection rounds.

Purpose

• To ensure the availability of approved life support medications required for emergency care.  This procedure applies to emergency medication storage and maintenance only and does not apply to medical equipment or supplies.

Procedure

• Maintenance of Emergency Life Support Medication Supply

  • The Pharmacist-in-Charge (PIC) and the Chief Nurse Executive (CNE), or their designees, shall ensure that approved emergency medications are available, secure, and accessible at all times in treatment carts.

  • Only approved emergency medications for life support (Appendix 1) shall be stocked in treatment carts in designated locations as determined by the institution EMRRC, except as specified in Section (c)(2)(D).

    • The institution EMRRC may, in coordination with the PIC, establish treatment cart medication quantities greater than the statewide requirements to meet local institution needs.

    • If the institution EMRRC, in coordination with the PIC, determines that other medications (e.g., intranasal naloxone, epipens) are necessary for emergency response specific to their patient population, these medications shall be stored outside the treatment carts in secured locations to ensure appropriate health care access only.  The institution EMRRC in coordination with the PIC shall establish the appropriate quantity of emergency medications based upon approved statewide emergency protocols.

  • Treatment carts shall be secured and sealed with a red tamper-resistant, numbered seal which must be broken to gain access to the medications.

  • Medications stored in treatment carts used for Advanced Cardiac Life Support shall be independently secured and accessed only by licensed nursing staff or by a Licensed Independent Practitioner. Refer to Lifeline on the Pharmacy Resources page for Emergency Medical Response Program (EMRP): Treatment Cart Lockable Tray to Secure Advanced Cardiac Life Support Medications at: Treatment Cart Lockable Tray to Secure Advanced Cardiac Life Support Medications.

  • A CDCR 7529, Treatment Cart Medication Inventory Log, of the medication contents of each treatment cart shall be attached to the outside of the cart in a readily visible place.  The log shall include the number from the red seal, date affixed, and the initials of the pharmacist affixing the seal.  The inventory log shall include the following information for each medication contained in the cart:

    • Generic name

    • Dosage form

    • Strength

    • Quantity (as determined by institution EMRRC and statewide minimums)

    • Shortest expiration date

  • The CNE, or designee, is responsible for ensuring the integrity of the red seal.  Nursing staff shall record the treatment cart red seal number(s) and verify refrigerated medication after daily inspection on the CDCR 7544, Treatment Cart Daily Check Sheet.

• Managing Treatment Cart Medications During Drug Shortages

  • The PIC, or designee, shall document a drug shortage by placing an order for the drug and receiving a zero ship quantity confirmation from the prime vendor.  The PIC, or designee, shall attempt to purchase the drug through a state-contracted pharmaceutical vendor by contacting headquarters Pharmacy Services at: m_CCHCSRxSupplyChain@cdcr.ca.gov.

  • The PIC, or designee, shall order unavailable approved treatment cart medications on a monthly basis as stated in Section (c)(2)(A).

  • The PIC, or designee, shall maintain the existing medication on the cart up to the business day prior to its expiration date but continue all efforts to obtain replacement during this time.  The PIC shall ensure removal of the expiring medication.

  • Alternatives to the approved treatment cart inventory shall be permitted when procurement is not possible due to drug shortages.  Alternatives shall be permitted for variations in salt, strength and packaging.  When using a salt variation, the PIC, or designee pharmacist,  shall confirm that the medication is approved by the Food and Drug Administration  for the intended indication prior to placement in the treatment cart. For off-label use, approval by the Systemwide P&T Committee shall be obtained prior to placement in the treatment cart.

  • Alternative medications in the treatment cart shall be marked with “high alert” auxiliary labels, precautions, and dose/administration directions.

  • The CDCR 7529, Treatment Cart Medication Inventory Log, affixed to the outside of the treatment cart shall be updated to reflect the alternative medication.

  • Alternative medications shall be replaced when approved treatment cart medications are received.

• Re-sealing the Treatment Cart After Opening

  • A yellow seal indicates the treatment cart was opened and is awaiting replenishment and verification of medications by a pharmacist.  A red, numbered seal indicates the treatment cart medications have been verified by a pharmacist and that the treatment cart is ready for use.  Only pharmacy staff shall have access to red, numbered seals.

  • Whenever the red seal has been broken, a licensed health care staff member shall secure the treatment cart with a yellow seal stocked in the treatment cart.  The CNE, or designee, shall notify pharmacy immediately after the red seal has been broken or by the start of the next pharmacy business day.  Nursing staff and a pharmacist shall coordinate replacement of medications and supplies before sealing with a red, numbered seal by the end of the pharmacy business day.

  • When medications are used, the CNE, or designee, shall provide pharmacy with the associated patient name and CDCR number.

  • A pharmacist shall thoroughly inventory the contents of the opened or unsealed treatment cart, replace any medication used, and document any medication replenished on the CDCR 7545, Pharmacy Treatment Cart Replenishment Log. 

  • The institution EMRRC and the PIC shall develop a process to address the possibility of insufficient treatment cart stock after pharmacy business hours.

  • The pharmacist shall re-seal the treatment cart with a red seal and replace the CDCR 7529, Treatment Cart Medication Inventory Log.

• Pharmacy Inspections

  • Once a month during medication storage area inspections, a pharmacist shall evaluate and inspect emergency treatment carts for integrity of the red seal and expiring medications.  Except in the case of drug shortages as in Section (c)(2)(C), medications expiring within the next 30 calendar days shall be replaced at the time of inspection.

  • Problems noted during the monthly inspection of treatment carts shall be documented consistent with the Health Care Department Operations Manual, Section 3.5.25, Inspecting Medication Storage Areas.

Procedure Overview

• Medications provided for patients of a California Department of Corrections and Rehabilitation (CDCR) facility by a correctional pharmacy or California Correctional Health Care Services (CCHCS)-contracted pharmacy may be used as long as the medications have been reviewed by a physician or pharmacist employed by or contracted with CDCR, CCHCS or a CDCR, CCHCS-contracted vendor.

Purpose

• To provide continuity of care, while ensuring that all medications administered to patients are correct and appropriate.

Procedure

• Orders for Continuing Medications Dispensed from a Non-CDCR Facility

  • When a patient is brought from a non-CDCR facility (e.g., community hospital, clinic, provider’s office) to a CDCR facility, the provider shall review the appropriateness of all recommended medication orders, determine the availability of formulary alternatives where indicated, and write medication orders when indicated.

  • When a patient has arrived with a supply of the ordered medication in their possession and the ordered medication is unavailable from the CDCR correctional pharmacy during business hours, licensed correctional clinic, or automated drug delivery system at the time of arrival and the provider determines that there is not an alternative available that is suitable for this patient, the medication may be ordered to be continued after the contents of the containers have been examined and positively identified by the patient’s physician or a pharmacist retained by CDCR, CCHCS or a CCHCS-contracted vendor.

  • The medications brought from a non-CDCR facility shall be administered as nurse administered (NA) or direct observed therapy (DOT) until such time as the medication labeling has been reviewed to be compliant as described in (c)(3).

  • For medications prescribed and dispensed from a narcotic treatment program (NTP), the provider shall document in the health record that the patient is receiving the medication from an NTP.

• Identifying the Medications

  • When medications have been provided by a CDCR, CCHCS-contracted pharmacy and the medications have not been in the  possession of the patient, medications bearing the label of the contracted pharmacy is indication that the medication has been identified and approved by a pharmacist and may be used within the CDCR facility.

  • When medications have been in the possession of the patient and the medications do not bear a CDCR label and the patient is admitted to a CDCR facility, the medication shall not be used unless the contents of the containers have been examined and positively identified by the patient’s physician or a pharmacist retained by CDCR, CCHCS or a CCHCS-contracted vendor  and after a Primary Care Provider, psychiatrist (if it is a psychotropic medication) or dentist (when the medication has been ordered for a dental condition) has approved and ordered their use.

    • During Pharmacy Hours

      • Nursing and pharmacy staff shall coordinate to allow a pharmacist to examine and verify medications brought from non-CDCR sources if the provider orders to continue the medication.

    • After Pharmacy Hours

      • If the medication is ordered to be administered after pharmacy business hours, the provider shall inspect the medication, and when necessary, positively identify and approve the medication, prior to releasing it for administration.

      • If the provider is not available for inspection of the medication, licensed health care staff shall contact the provider on-call for further guidance.

      • When the pharmacy reopens and if the medication is still needed, the pharmacist shall verify the order and, if possible, re-dispense the medication with CDCR stock.

• Labeling Medications from a Non-CDCR Pharmacy

  • When medications have been provided by a CDCR, CCHCS-contracted pharmacy and comply with labeling requirements pursuant to Health Care Department Operations Manual, Section 3.5.16, Medication Inventory Management, Labeling, and Storage, the institution pharmacy is not required to place an additional label upon the product. If any information is missing, then the medication shall be labeled with a CDCR label and administered NA or DOT until the medication can be provided with an appropriate label.

  • Pharmacy, once available, shall affix a CDCR medication label to all medications dispensed from a non-CDCR-contracted pharmacy to facilitate documentation of administration. Where the medication is to be self-administered by the patient, the CDCR label shall indicate KOP administration. If possible, the original label from the non-CDCR pharmacy shall remain visible for all medications dispensed by a non-CDCR pharmacy but administered within the CDCR facility, including medications for KOP administration.

• Onsite Administrations of Narcotic Treatment Program Medications during Modified Programming

  • In the event of modified programming or other special circumstance in which an NTP needs to deliver a supply of controlled substances used for substance abuse treatment and detoxification for a patient, a pharmacist shall verify the contents and quantities delivered. The handoff between the NTP and pharmacist shall be documented on the CDCR 7457, Pharmacy Chain of Custody Log – Patient’s Methadone Supply (Delivered by NTP).

  • The patient-specific medications shall be kept locked and separate from the pharmacy’s inventory until the medications can be delivered to a licensed correctional clinic.

  • The medication handoff between pharmacy and nursing staff shall be documented on the CDCR 7457.

  • Nursing staff shall secure the controlled substances in a locked cart, cabinet, or drawer and document the security of the medications in their possession on the CDCR 7456, Nursing Chain of Custody Log – Methadone Supply (Delivered by NTP).

Procedure Overview

• After-hours pharmacy services shall be available whenever the local pharmacy is closed and shall be consistent with options approved by the Systemwide Pharmacy and Therapeutics Committee or the Systemwide Medication Management Subcommittee.  The most cost-effective option shall be prioritized, provided it is conducive to the needs of the patient.  Proper stocking and inventory control, as required in the Health Care Department Operations Manual (HCDOM), Section 3.5.4, Automated Drug Delivery System, will provide more timely access and mitigate the need for other, more costly processes to be utilized to meet the immediate needs of the patient. For purposes of this policy, pharmacy services shall be deemed available when California Department of Corrections and Rehabilitation (CDCR) processes, with respect to after-hours services, have been followed or a CDCR pharmacist was consulted for clinical or after-hours assistance.

Purpose

• To ensure that pharmacy services are available for consultation and medication needs on a 24-hour basis.

Responsibilities

• Statewide

  • The CDCR and California Correctional Health Care Services departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative and clinical systems are in place and appropriate tools, training, technical assistance, and resources are available to:

  • Ensure the furnishing or dispensing of medication from the Correctional Pharmacy and the CDCR-Central Fill Pharmacy comply with federal and state requirements and community standards of practice.

  • Provide the availability of specific medication to authorized personnel and health care treatment areas when necessary to address the most common medication needs when providing after-hours treatment for CDCR patients in compliance with federal and state requirements.

• Regional

  • Regional Health Care Executives and Regional Pharmacy Services Managers are responsible for operationalizing this policy and compliance with federal and state requirements at the subset of institutions within an assigned region.

• Institutional

  • The Chief Executive Officer (CEO) has overall responsibility for ensuring the implementation and enforcement of this procedure, compliance with federal and state requirements, and maintaining a local operating procedure (LOP).

  • The Pharmacist-in-Charge (PIC) shall be responsible for:

    • Compliance with federal and state requirements concerning medication provision.

    • Maintaining adequate quantities of essential and commonly used medications in a licensed correctional clinic (LCC) or automated drug delivery system (ADDS).

    • Providing a list of pharmacists to contact in a specified order to respond when the PIC is unavailable as described in Section (e)(1)(A)5.

    • Reviewing after-hours medication needs and optimizing medication availability to meet clinical needs.

  • Each institution shall maintain an LOP to be reviewed and approved by the institution Medication Management Subcommittee annually.

  • The medications available in the ADDS and LCC shall be determined as described in HCDOM, Section 3.5.4, Automated Drug Delivery System, and Section 3.5.3, Furnishing or Dispensing Medication to Legally Authorized Persons or Entities: Licensed Correctional Clinics, respectively.

Local Operating Procedure Addendum

• When an institution has pharmacists who volunteer for callback, an addendum to the LOP is required to outline:

• Implementation and processes related to the maintenance of a voluntary list.

• Steps that shall be followed before an SRN can contact the voluntary callback pharmacist to dispense a medication if the medication is available within the institution’s pharmacy.

Procedure

• Access to After-Hours Pharmacy Services

  • The institution shall complete the following steps to access after-hours pharmacy services:

    • Implement the procedures indicated in the HCDOM, Section 3.5.4, Automated Drug Delivery System and HCDOM, Section 3.5.3, Furnishing or Dispensing Medication to Legally Authorized Persons or Entities: Licensed Correctional Clinics, to properly manage and monitor medication use and needs. These procedures include, but are not limited to:

      • Establishing and maintaining:

        • A floor stock medication supply for each health care location licensed pursuant to California Health and Safety Code, Title 22.

        • A floor stock medication supply for each LCC pursuant to California Business and Professions Code (BPC), Division 2, Chapter 9, Article 13.5, Section 4187.

        • Medication par levels within each ADDS pursuant to BPC, Division 2, Chapter 9, Article 13.5, Section 4187.5.

      • Following the procedure in Section (e)(1)(A)2., when the institution demonstrates an inability to meet patient needs following full implementation and adherence with the above.

    • Local institution staff shall follow the procedures outlined in their LOP to locate required medications in other medication storage areas when a single location is unable to meet the needs of a patient. Staff shall have access to medications located at any LCC using the following process:

      • Use personal access to remove medications from an ADDS, or

      • Complete an electronic requisition to move a medication between two LCCs within the same institution.

      • Follow the procedure in Section (e)(1)(A)3. if the institution demonstrates an inability to meet patient needs following full implementation and adherence with the above.

    • The Supervising Registered Nurse (SRN) on duty shall contact the on-call provider if it is determined that the medication is not readily available and may be held until obtained or an order for an available alternative is provided. If necessary, the SRN shall notify the PIC, or designee, that a medication is needed. If the institution cannot reach the PIC, follow the procedure in Section (e)(1)(A)4.

    • When an institution has access to a contracted pharmacy vendor (e.g., retail pharmacy, hospital discharge pharmacy) that can supply patient-specific prescription coverage, a prescription shall be provided for a quantity not to exceed a one-week supply. Institution staff shall be responsible for transporting the prescription from the contracted vendor to the institution.  The patient-specific prescription shall be administered as Nurse Administered (NA) or under Directly Observed Therapy (DOT). Pharmacy shall dispense an appropriate medication supply on the next business day pursuant to HCDOM, Section 3.5.23, Medications Brought from a Non-CDCR Facility.  If the institution demonstrates an inability to meet the patient needs following attempts to obtain a supply from a contracted pharmacy vendor, follow the procedure in Section (e)(1)(A)5. 

    • Voluntary callback of a pharmacist may be attempted if the procedure in Section (e)(1)(A)4. has failed to meet patient needs.

      • The institution shall develop an LOP to determine how voluntary callback shall be authorized, if available, to meet patient needs.

      • Voluntary callback is a request for staff to report to the institution during off-duty hours that do not run contiguously with a scheduled shift or meal break. Pharmacists are not required to participate in voluntary callback.

        • The PIC shall generate a voluntary callback list following written requests from the pharmacists for inclusion as defined by the LOP. If no pharmacist wishes to be included, then this option shall not be utilized.

        • The PIC shall place the names of all pharmacists requesting inclusion onto this list based on seniority with the most senior pharmacist first and provide to all locations as specified within the LOP.

        • The institution staff utilizing the voluntary callback list shall be instructed to start with the first name on the list at each occurrence and work their way down.

      • Compensation for voluntary callback is pursuant to the current Bargaining Unit 19, Memorandum of Understanding.

    • If all the steps above have failed to meet patient needs and in the on-call provider’s professional judgment, a delay in therapy may cause potential harm, consider transitioning the patient to a higher level of care.

• Callback Reporting

  • Each month, the PIC shall submit the CDCR 7531, After-hours Medication Call Log, to the institution management team and the Statewide Chief of Pharmacy Services.

  • The PIC shall also analyze the CDCR 7531 for the purpose of adjusting the after-hours inventory to better meet patient needs, institution and statewide process improvement changes, and practitioner education.

Procedure Overview

• The Pharmacist-in-Charge (PIC), or designee, shall regularly inspect all licensed medication storage areas for compliance with licensing requirements, federal and state laws, statewide policies and procedures, and local operating procedures (LOPs).  United States Drug Enforcement Administration (DEA) and the California State Board of Pharmacy-identified controlled substances shall be accurately maintained, documented, inventoried, and reconciled.  All medications shall have current dates, be in useable condition, and be properly labeled.  Storage areas shall be clean, uncluttered, well-lit, secured, and contain only properly authorized medications.

Purpose

• To ensure that unusable medications are not available for patient use and that medications are stored safely and under the proper conditions pursuant to national and state medication storage standards (e.g., United States Pharmacopeia, Centers for Disease Control and Prevention, California Code of Regulations Title 22, California Business and Professions Code Division 2, Chapter 9, Article 13.5).

Procedure

• Medication Quality Assurance Rounds

  • The PIC, or designated pharmacist, shall make Medication Quality Assurance Rounds to inspect all licensed medication storage areas inside and outside of the pharmacy at least monthly, or as often as needed as determined by the local Medication Management Subcommittee and the PIC to comply with California Correctional Health Care Services policy and applicable federal and state requirements.

  • The pharmacist completing the licensed correctional pharmacy inspection shall complete the CDCR 7477-A, Licensed Correctional Pharmacy Inspection Checklist, print their name, and sign and date the form. For institutions with more than one licensed pharmacy, a separate CDCR 7477-A shall be completed for each licensed pharmacy.

  • The pharmacist completing the non-pharmacy licensed medication storage area inspection shall complete the CDCR 7477-B, Non-Pharmacy Licensed Medication Storage Area Inspection Checklist, print their name, and sign and date the form.

    • The Registered Nurse (RN), Licensed Vocational Nurse (LVN), or Psychiatric Technician (PT) present at the completion of the medication storage area inspection for health care treatment areas and licensed units shall acknowledge receipt of the CDCR 7477-B by printing their name, and signing and dating the form.  The pharmacist shall provide a copy of the CDCR 7477-B to the RN, LVN, or PT who signed the form. The copy shall be processed pursuant to the LOP.

    • For dental clinics, the dentist present at the specific clinic shall acknowledge receipt of the CDCR 7477-B by printing their name, and signing and dating the form.  The pharmacist shall provide a copy of the CDCR 7477-B to the dentist who signed the form.  The copy shall be processed pursuant to the LOP.

  • The pharmacist completing the automated drug delivery system (ADDS) medication storage inspection shall complete the CDCR 7477-C, Automated Drug Delivery System Medication Storage Inspection Checklist, print their name, and sign and date the form.

  • The PIC shall review all completed CDCR 7477-As, 7477-Bs, and 7477-Cs for all licensed medication storage areas, the correctional pharmacy, and all ADDS, print their name, and sign and date the forms.  A copy of all completed CDCR 7477-As, 7477-Bs, and 7477-Cs shall be provided to the Chief Executive Officer (CEO) or designee.

• Inspection Requirements

  • A DEA controlled substances audit shall be completed at least monthly or more often if needed.  This audit shall include the following:

    • A DEA Schedule III-V medication audit which shall include:

      • A physical inventory performed and compared against the balance shown in the Inventory Control Method.

      • Verify that:

        • Each dose of the controlled substance is properly documented.

        • Damaged or refused medications already issued for patients are disposed of properly in accordance with the Health Care Department Operations Manual (HCDOM), Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff, and Section 3.5.9, DEA Schedule II-V Controlled Substances.

    • A DEA Schedule II medication audit which shall include:

      • Using the reconciled on-hand inventory from the prior month’s count, which shall become the starting inventory for the present audit.

      • Verifications of additions to stock-on-hand which shall include, but is not limited to:

        • Pharmacy stock received from vendors (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • DEA-registered licensed unit stock received from pharmacy (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • Licensed-unit stock received from DEA-registered licensed units within the same institution (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • Pharmacy stock received from DEA-registered licensed units (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • Stock transfers between the Correctional Pharmacy and any ADDS which it registers and operates (Note: in this case, all movement is considered to occur within the same DEA-registered pharmacy, therefore a DEA 222 Form is not required for drug movement).

      • Verification of deductions to stock-on-hand which shall include, but is not limited to:

        • Pharmacy stock transferred to an ADDS (Note: in this case, all movement is considered to occur within the same DEA-registered pharmacy, therefore a DEA 222 Form is not required for drug movement).

        • Pharmacy stock sent to a reverse distributor (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • Pharmacy stock transferred to a DEA-registered licensed unit (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • Pharmacy dispenses to a patient pursuant to a valid prescription or computerized physician order entry (CPOE) (Note: CPOE only valid with two-factor authentication).

        • Pharmacy stock transferred to another licensed pharmacy (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • ADDS inventory dispensed for patient administration.

        • DEA-registered licensed unit stock being transferred to a different DEA-registered licensed unit within the same institution (Note: DEA controlled substances schedule II can only be moved from one registered location to another registered location via a DEA 222 Form).

        • DEA-registered licensed unit stock administered to patients.

        • DEA controlled substances dispensed for patient administration of which drug is wasted.

        • DEA-registered licensed unit stock being transferred to pharmacy.

      • Using the starting inventory plus additions to stock, minus deductions from stock which shall be the expected inventory on-hand.

      • A physical inventory of stock on-hand shall be conducted and compared with the expected inventory on-hand for each medication.

    • All discrepancies shall be identified and resolved.  Any discrepancy which cannot be resolved shall be handled pursuant to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, and Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

  • All medication storage areas shall be inspected for unusable medications and the storage of unauthorized floor stock items, all of which shall be removed and disposed of pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff, and Section 3.5.16, Medication Inventory Management, Labeling, and Storage.

  • All look-alike/sound-alike medications, high-alert medications, and hazardous medications shall be properly identified and stored.

  • Heat, light, and moisture requirements shall be appropriate for the medications stored.

    • Health care staff shall record room, refrigerator, and freezer (where applicable) temperatures pursuant to the HCDOM, Section 3.5.16, Medication Inventory Management, Labeling, and Storage.

    • The Chief Support Executive (CSE) shall be responsible for ensuring the availability and proper maintenance (including, but not limited to, temperature monitoring) of licensed medication storage areas and equipment, in accordance with manufacturer recommendations and policy in all health care service areas.  If a temperature problem arises outside of the pharmacy, health care staff shall notify the pharmacy immediately for oversight to ensure that medications are maintained in good condition or replaced.

    • Evidence of excess moisture in the refrigerator shall be noted and reported to the CSE during normal business hours (or to the Supervising Registered Nurse II if after hours) if this will affect the condition or safety of stored medications.

  • Medication areas shall be clean and free of vermin.

  • Medications shall not be stored on the floor.

  • All shelves, cabinets, drawers, dressing carts, and medication carts shall be opened for inspection to ensure proper labeling and storage of medications.  Medications shall be stored only in authorized areas, and only authorized floor stock items or patients’ medications that are properly labeled shall be stored in these areas. Dangerous drugs as defined by Business and Professions Code, Division 2, Chapter 9, Article 2, Section 4022 shall only be stored in licensed areas which include the pharmacy, licensed correctional clinics, ADDS, and licensed inpatient units licensed by the California Department of Public Health.

  • In accordance with California Health and Safety Code, Title 22, no medications may be left at bedside within licensed inpatient units with the exception of sublingual or inhalation forms of emergency drugs specifically ordered for “bedside use” by an authorized provider pursuant to the HCDOM, Section  3.5.21, Rescue Medications.

  • For licensed units with an emergency medication storage unit, the drawer, cabinet, or cart shall be reviewed monthly and the review shall be documented on the CDCR 7477-B.

• Reporting Requirements

  • Medication inspection reports shall be completed with inspection dates and observations.  Additional notes concerning any problems or suggestions shall be listed.  The report shall be sent to the CEO, or designee, and other supervisory staff or committees as appropriate and kept on file by the pharmacy for three years.

  • Performance Improvement Plans shall be developed by the CEO, or designee, with the assistance of the supervisor responsible for the medication area where a deficiency was found.  Performance Improvement Plans shall include how the problem will be resolved, implementation date, monitoring mechanism, and target resolution date.  Progress shall be monitored by the ongoing monthly inspections.

Procedure Overview

• Any suspected breach of security or known medication theft or loss from the pharmacy or other medication storage areas due to break-in, theft, or unexplained inventory shortages shall be promptly reported and investigated.

Purpose

• To ensure breaches of security or losses due to theft or another cause are addressed promptly, medications are not diverted for misuse or abuse, and inventory shrinkage does not impact patient access to medications.

Procedure

• This procedure applies to:

  • Discovery of a break-in to the pharmacy or to any other licensed areas where medications are stored (including, but not limited to, a Correctional Treatment Center, licensed correctional clinic, or automated drug delivery system) whether or not a loss of medication is detected; or

  • Discovery of a theft or other loss of medications at the pharmacy or any licensed areas where medications are stored.

• The Pharmacist-in-Charge (PIC), or designee, shall be notified immediately by the person discovering the break-in, theft or loss. 

• The PIC, or designee, shall perform an immediate assessment and report the breach in security or medication loss in the pharmacy or non-pharmacy medication storage area pursuant to the Health Care Department Operations Manual (HCDOM), Section 5.1.4, Reporting of Actual or Suspected Incidents of Fraud, Errors, and Improper Governmental Activities.

• Drug Enforcement Administration (DEA) controlled substances destroyed as waste requires a witness. Unwitnessed waste shall be treated as loss.

• When a pharmacy reports a DEA controlled substance loss to the California State Board of Pharmacy (BOP) or to the DEA, an inventory reconciliation report shall be prepared for the identified DEA controlled substances lost.  Refer to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, for the requirement of an inventory reconciliation of DEA controlled substances.

• Notifications

  • California Department of Corrections and Rehabilitation Institutions

    • During pharmacy business hours, the PIC, or designee if the PIC is unavailable during the required reporting period, shall notify in writing the Chief of Pharmacy Services, the Regional Pharmacy Services Manager, and the following stakeholders at the institution as soon as possible after discovery and prior to the end of the shift:

      • Investigative Services Unit

      • Warden

      • Chief Executive Officer

      • Chief Nurse Executive

    • After pharmacy business hours, the Supervising Registered Nurse II on duty shall notify the stakeholders listed in Section (c)(6)(A)(1) and the PIC, or designee if the PIC is unavailable during the required reporting period.

    • For a theft or loss in the dental area or a provider treatment area, the PIC, or designee if the PIC is unavailable during the required reporting period, shall notify the Supervising Dentist or the Chief Medical Executive, respectively, as soon as possible and no later than the next business day.

  • Central Fill Pharmacy (Food and Drug Administration-Licensed Area)

    • During pharmacy business hours, the PIC, or designee if the PIC is unavailable during the required reporting period, shall notify in writing the following as soon as possible after discovery and prior to the end of the shift:

      • California Highway Patrol

      • Chief of Pharmacy Services

      • Deputy Director, Medical Services

      • Business Services, California Correctional Health Care Services (CCHCS), pursuant to HCDOM, Section 5.5.2, Building Security and Access

    • After pharmacy business hours, the alarm company shall notify the Central Fill Pharmacy’s property management, Business Services, CCHCS, and California Highway Patrol.  If a break-in is confirmed, Business Services, CCHCS, shall notify the PIC or a pharmacy supervisor at the Central Fill Pharmacy.  The PIC, or designee if the PIC is unavailable during the required reporting period, shall then notify the stakeholders listed in Section (c)(6)(B)(1).

• After notifying the Chief of Pharmacy Services, the PIC, or designee if the PIC is unavailable during the required reporting period, shall notify the following agencies as required:

  • California State Board of Pharmacy

    • The pharmacy or clinic shall report to the BOP any drug loss, including amounts and strengths of each drug, the date of discovery of the loss, and the identified causes for the loss within 30 days of discovery of the following:

      • Any loss of DEA controlled substances in one of the following categories that causes the aggregate amount of unreported losses discovered in that category, on or after the same day of the previous year, to equal or exceed:

        • For tablets, capsules, or other oral medications, 99 dosage units.

        • For single-dose injectable medications, lozenges, film (such as oral, buccal, and sublingual), suppositories, or patches, 10 dosage units.

        • For injectable multi-dose medications, medications administered by continuous infusion, or any other multi-dose unit not described above, two or more multi-dose vials, infusion bags, or other containers.

      • Any other significant loss as determined by the PIC, or designee if the PIC is unavailable during the required reporting period, including, but not limited to, losses deemed significant relative to the dispensing volume of the pharmacy.

    • If the pharmacy or clinic is unable to identify the cause of the loss, further investigation shall be undertaken to identify the cause and actions necessary to prevent additional losses of DEA controlled substances. 

    • Every pharmacy shall report to the BOP within 14 days of discovery any loss (DEA controlled substance or non-DEA controlled substance) involving theft, diversion, or self-use by licensed individuals employed within the pharmacy.  Refer to the Business and Professions Code, Chapter 9, Division 2, Article 6, Section 4104, Licensed Employee, Theft or Impairment: Pharmacy Procedures, for reporting details.

  • Drug Enforcement Administration

    • Pursuant to Code of Federal Regulations, Title 21, Chapter II, Part 1301, Section 1301.76, Other Security Controls for Practitioners, a registrant shall notify the administration in writing of the theft, significant loss or pattern of loss of any DEA controlled substances within one business day of discovery of such theft or loss.  The registrant shall also complete and submit an electronic DEA Form 106 within 45 days after discovery of the theft or loss.  Electronic DEA Form 106 is available at the following link: https://apps.deadiversion.usdoj.gov/TLR/.  (Refer to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances.)

• The PIC, or designee if the PIC is unavailable during the required reporting period, shall document the date and times of notification of each of the stakeholders listed in Section (c)(6) and federal and state agencies as applicable.  The PIC, or designee, shall make a final written report within 72 hours of the conclusion of the investigation.

  • The report shall contain circumstances surrounding the breach of medication security and/or loss of medication, including the amount and type of medication losses if applicable, and the resolution of any investigation whenever possible.

  • The Chief of Pharmacy Services shall request and determine the frequency of supplemental reports if the investigation becomes lengthy.

  • All reports shall be sent to the stakeholders listed in Section (c)(6), the institution Medication Management Committee, and federal and state agencies as applicable.

Policy

• This policy provides for the continued legal operation of the pharmacy during a temporary absence of the pharmacist as permitted by federal and state law.

Purpose

• To ensure that pharmacy operations may continue during the temporary absence of a pharmacist as permitted by federal and state law.

Procedure

• The Chief Executive Officer and the Pharmacist in Charge (PIC) are responsible for providing pharmacist coverage for the pharmacy during the facilities hours of operation.

• It is permissible for the pharmacist to be temporarily absent from the licensed pharmacy for the performance of authorized duties within the institution, breaks, and meal periods.

• During temporary absences, the pharmacist on duty and the PIC remain responsible for all work.  No work performed during a temporary absence of a pharmacist shall leave the pharmacy without being checked by a pharmacist.

• During temporary absences, the pharmacist on duty and the PIC remain responsible for the security of the pharmacy. Any issues with pharmacy security shall be addressed by the Health Care Department Operations Manual, Section 3.5.26, Break-in, Theft/Loss From Pharmacy or Medication Storage Areas.

Procedure Overview

• The California Department of Corrections and Rehabilitation (CDCR) and California Correctional Health Care Services (CCHCS) shall maintain a contingency plan for correctional institutions in the event of a disruption of local institution pharmacy services.

Purpose

• To identify the facility level procedures, including a post-disruption recovery plan, that shall be followed in the event of a disaster or network degradation causing an interruption to local institution pharmacy services.

Responsibilities

• CDCR and CCHCS departmental leadership, at all levels of the organization, within the scope of their authority, shall ensure administrative, custodial and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available.

• In the event of any network slowdown or outage, lack of electrical power, significant reduction in workforce, or other immediate negative impact to pharmacy operations, the institution’s pharmacist-in-charge (PIC) or designee shall:

  • Report the situation to the CCHCS Information Technology Services Division via the CCHCS Service Portal.

  • Notify their Regional Pharmacy Services Manager and the Statewide Chief, Pharmacy Services, or designees.

  • Be the local liaison between the Central Pharmacy Services and institutional pharmacy staff to assist with the continued function and recovery of pharmacy operations.

Procedure

• Pharmacy Emergency Team

  • The Pharmacy Emergency Team shall include the following staff:

  • Statewide Chief, Pharmacy Services or designee

  • Any Regional or Central Pharmacy Services Managers or designees

  • Local PIC or designee

• Emergency Preparedness

  • The pharmacy shall have the CCHCS Electronic Health Record System (EHRS) Interdisciplinary Downtime Procedures & Downtime Viewer Guide available and a sufficient number of blank forms to account for a week of downtime, including:

    • Downtime Medication Administration Records (MAR) form

    • Downtime prescription labels

    • Downtime Filled Medications Log

  • The pharmacy shall maintain a 96-hour reserve of medications, especially essential medications including, but not limited to, analgesics, antibiotics, anti-emetics, anti-psychotics, and insulins, for use in the event of a disaster that constrains the institution’s ability to contact or access external resources.

• Network Slowdown

  • A network slowdown occurs when pharmacy software is impacted, causing pharmacy operations to be reduced or available at limited capacity.

  • When a network slowdown is identified, the institution pharmacy staff shall complete an Information Technology (IT) ticket online via the CCHCS Service Portal, by calling 1-888-735-3470, or by calling the extension to the local IT department. 

  • The pharmacy staff shall notify the PIC or designee.

  • The PIC, or designee, shall:

    • Send an email with system issues to CDCRPharmacyEmergencyTeam@cdcr.ca.gov.

    • Notify local health care staff, including the Chief Executive Officer (CEO), Chief Medical Executive, Chief Nurse Executive, and Chief Psychiatrist, of the system slowdown and potential impact on patient care.

  • Upon notification of a network slowdown, members of the Pharmacy Emergency Team shall:

    • Coordinate with the pharmacy software vendor and CCHCS IT to determine the nature and extent of the network issue and a proposed course of action.

    • Determine a frequency for contact between relevant parties for updates regarding the network issue, operational impact, and course of action.  Relevant parties may include the following:

      • Pharmacy Emergency Team

      • Local clinical leadership

      • Institution CEO(s)

      • Institution Health Care IT (HCIT) staff

    • Determine a course of action consistent with the function of the institution and nature of the issue. Remediation may include, but is not limited to:

      • Prioritizing STAT (immediate) and same-day prescriptions for local fill.

      • Employing and recording verification and fill functions using paper methods and forms.

      • Moving verification functions to an alternate site (e.g., central pharmacy) with fill function performed by the local institution.

      • Moving all essential pharmacy functions to an alternate site with an arrangement for delivery to the impacted institution.

• Network Outage, Lack of Electrical Power, or Other Immediate Negative Impact To Pharmacy Operations

  • In the event local institution pharmacy operations are impacted by an inability to access pharmacy software or meet the immediate pharmaceutical needs of the institution, the following shall occur:

  • The local PIC shall determine operational status and notify the Pharmacy Emergency Team.

  • When necessary to obtain further details of the network issue and operational impacts and to determine a course of action, the Pharmacy Emergency Team shall conduct a conference call with all relevant parties, which may include:

    • Local clinical leadership

    • Institution CEO(s)

    • Institution HCIT staff

    • Regional HCIT manager(s)

  • Remediation shall be individualized with consideration of the following:

    • The institution(s) impacted

    • Projected outage duration

    • Volume of prescriptions

    • Nearest facility with operational pharmacy software

    • Emergent needs

  • The course of action may include, but is not limited to:

    • Dispensing medications from a nearby facility.

    • Printing labels from a nearby facility.

    • Delivering medications, labels, or MAR from a nearby facility.

    • Moving verification and all essential functions to an alternate site (e.g., central pharmacy) to reduce recovery time.

    • Accessing information from a system attached to an unaffected network (e.g., CDCR Enterprise Information Services Network, CCHCS Health Care Network).

  • Refer to the Health Care Department Operations Manual, Section 3.5.4, Automated Drug Delivery System, for automated drug delivery system downtime procedures, if applicable.

• Recovery

  • A recovery plan shall be developed by the Pharmacy Emergency Team based upon the nature of the failure and the time involved to reestablish normal operations. The Pharmacy Emergency Team shall communicate this plan to interested parties, which may include, but is not limited to:

    • File maintenance.

    • Notification to institutions once recovery is complete.

Policy

• This policy promotes the health and safety of patients by ensuring the safe administration or delivery and thorough documentation of medications by licensed health care staff.

Responsibility

• Statewide

  • The Deputy Director (DD), Medical Services; DD, Mental Health; DD, Dental Services; DD, Nursing Services; DD, Institution Operations; and Statewide Chief of Pharmacy Services are responsible for the statewide planning, implementation, and evaluation of the Medication Administration policy.

• Regional

  • The regional leadership team is responsible for ensuring adherence to this policy at the subset of institutions within an assigned region.

• Institution

  • The Chief Executive Officer (CEO) is responsible for partnering with all stakeholders to operationalize this policy.

Procedure

• Medication and Patient Verification Procedures

  • Licensed health care staff shall issue, administer, monitor, and document administration or delivery of all medications ordered by authorized prescribers (e.g., physician, nurse practitioner, physician’s assistant, dentist, psychiatrist, podiatrist) within their scope of licensure under California law.

  • Prior to administering medications, licensed health care staff shall:

    • Check each patient’s Electronic Health Record System (EHRS) Medication Administration Wizard or electronic Medication Administration Record (MAW or MAR) for potential allergies.

    • Verify the medication order has not expired.

    • Verify the medication has not expired.

  • Medications shall be prepared by licensed health care staff when the patient presents for their medications at the medication line or window.

  • Prepared medications shall be administered by licensed health care staff on the shift they are prepared.

  • The same licensed health care staff who prepares and administers the unit dose package medication shall document the administration of the medication during the same shift that they are prepared or packaged.

  • At the time of medication administration, licensed health care staff shall ensure that the “Six Rights” are followed (refer to the EHRS Workflow 500-90, Nursing_Care Admin BCMA – Med Line):

    • Right Patient – Medication administration staff shall verify the correct patient by checking the patient’s California Department of Corrections and Rehabilitation (CDCR) picture identification (ID) card and one other patient identifier.  In restricted housing units, the patient’s picture ID or bed card with picture should be posted next to the cell door. Custody staff shall be consulted if there is any concern regarding the accurate ID of the patient or need for ID card replacement pursuant to California Code of Regulations, Title 15, Section 3019, Identification. 

    • Right Medication – Compare the medication label to the MAW or MAR to verify medication. Barcode scanning shall be employed to verify the medication before administration (including for KOP [Keep-on-Person] and for release medications) unless not possible (e.g., during downtime).

    • Right Dose – Compare the medication label to the MAW or MAR to verify dose.

    • Right Route – Compare the medication label to the MAW or MAR to verify route.

    • Right Time – Compare the medication label to the MAW or MAR to verify time.

    • Right Documentation – Licensed health care staff administering medication shall record the medication administered on the patient’s MAW or MAR directly after administration.  The route of administration and injection site shall also be recorded on the MAW or MAR if a medication is administered by injection.  Additional information pertinent to the medication administration shall be documented in the health record following statewide-approved workflows, policies, and procedures.

  • Medications ordered on an “AM and PM” or twice daily basis shall be administered with at least eight hours between the two dosing times unless otherwise indicated on the medication order or on the CDC 7221, Physician’s Orders.

  • Hour of Sleep (HS) Medications – When clinically indicated, medications may be ordered at bedtime, or HS.  Medications ordered at bedtime, or hour of sleep, shall be administered after 2000 hours.

  • Every effort shall be made to ensure that unit dose medications are not opened until the time of administration.

  • At no time shall medication of any type be slid or placed under the door or between the door and doorjamb of a patient’s cell.

  • If unable to access the EHRS, follow downtime procedures and the EHRS Workflow 500-100, Integrated_Medication Administration Non-Scanning and submit paper MAW or MARs and pertinent documentation to Health Information Management (HIM).

• Medication Administration Times

  • Outpatient (Non-Licensed Units)

    • Medication shall be administered up to four times daily in medication lines with the exception of Fire Camps. A sample administration schedule may include:

      • Morning (AM)

      • Noon

      • Evening (PM)

      • Bedtime, or HS (after 2000 hours)

    • Medications may be administered outside of the time frames identified above at the discretion of the provider.

  • Inpatient (Licensed Bed Units)

    • Inpatient includes beds licensed by the California Department of Public Health, e.g., Correctional Treatment Center (CTC), Mental Health Crisis Bed, Psychiatric Inpatient Program, Skilled Nursing Facility (SNF), and Hospice.

    • Dosages shall be administered within one hour of the prescribed administration time.

    • Drugs ordered “STAT” shall be administered immediately in the nursing unit or within one hour if the medication needs to be obtained from the pharmacy during regular pharmacy business hours.

    • Drugs ordered “STAT” shall be administered immediately in the nursing unit or within two hours if the pharmacy is closed.

    • In the event the medication is not available within the specified time periods, refer to Health Care Department Operations Manual (HCDOM), Section 3.5.24, After-Hours Pharmacy Services, for additional directions.

• Medication Administration Lines – General Population

  • All general population (GP) patients, including those housed in Level IV 180 design units, shall receive all medications at a medication window as a routine function of regular programming.  Cell front medication delivery shall not occur in a GP setting unless there is no other reasonable alternative available as determined by the CEO, or designee, in consultation with the Warden or designee.

  • Custody staff shall be present at the designated medication distribution points to directly observe the medication process, maintain order, and provide assistance if necessary.

  • Patients shall bring a cup of water to the designated medication distribution point unless Local Operating Procedures (LOPs) direct otherwise and remove any mask or face covering.

  • Medication lines shall continue until the last patient in line has received their prescribed medication. For all patients who have not received their medications, refer to HCDOM, Section 3.5.30, Medication Adherence.

  • At the conclusion of the medication line, the licensed health care staff who administered the medications shall review the post-medication report, and print as necessary, to identify patients who did not present to the designated medication distribution point to receive their routine medications. The licensed health care staff shall coordinate with custody staff to attempt to locate the patient for:

    • Medication administration.

    • Documentation of refusal of medication and the reason for refusal on the MAW/MAR.

    • Documentation of barriers that prevented the patient from presenting to the medication line.

• Medication Administration at Cell Front – Restricted Housing Units

  • Custody staff shall accompany licensed health care staff on medication administration rounds to facilitate opening of the food port or the cell door, if necessary, for administration of medications.

  • The patient shall be instructed to turn on the light, bring a cup of water, remove any mask or face covering, and come to the cell front to be clearly visible.

  • Licensed health care staff shall provide the patient’s oral medication through the opened cell door, food port, or bars of the cell door.  At the request of licensed nursing staff, custody staff shall open cell doors during medication administration to permit reasonable visualization of the patient’s ingestion of medication.

  • At no time shall medication of any type be slid or placed under the door or between the door and doorjamb of a patient’s cell.

  • Medication administration shall continue until all patients in the unit with prescribed medications have received or refused the prescribed medication.

• Medication Administration During Lockdown or Modified Program

  • When the state of the lockdown or modified program is such that no movement is permitted, medication administration may occur at the cell front or podium pass until restrictions on movement are adjusted to the extent that once again permit patient access to the medication window.

  • If GP patients on lockdown or modified program are provided any yard access, programming, or receive their meals in the dining facility, they also have access to the medication window to receive their medication.  Health care shall confer with custody management to determine the safest way to distribute medication.

  • The institution shall work towards routine medication delivery promptly, and this shall be discussed at the daily Program Status Report meetings between health care and custody managers. When the lockdown or modified program is more than 14 days, the institution shall notify the Regional Health Care Executive and Associate Director, Division of Adult Institutions, and any medication delivery concerns not resolved at the institutional level shall be addressed at this meeting.

  • The method of medication delivery for the above concerns shall be determined or approved by the CEO, or designee, in agreement with the Warden, or designee.

• Methods of Medication Administration or Delivery

  • Recommendations on selecting a medication administration or delivery type is available on Lifeline at https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Best-Practices/kopnadot-recommendations.pdf

  • Directly Observed Therapy (DOT)

    • Required for patients:

      • Receiving medications with Penal Code (PC) 2602 or PC 2604 court orders or other court-ordered process.

      • Receiving any Drug Enforcement Administration (DEA) controlled substances except those used in the treatment of substance use disorder and approved for KOP by the Systemwide Pharmacy and Therapeutics (P&T) Committee.

      • Receiving medications on the Systemwide P&T Committee Mandatory Crush/Open List.

      • Receiving medications for active tuberculosis (TB) or suspected TB disease.

      • Receiving medications for latent TB infection.

      • Whenever specified by the prescriber.

    • DOT Procedure

      • The patient shall present to the medication line (GP) or the cell front (restricted housing units) with a cup of water and remove any mask or face covering.

      • Licensed health care staff administering medication shall verify the patient’s identity and use the “Six Rights” of medication administration by following the steps outlined in Section (c)(1)(F).

      • Licensed health care staff shall provide the prescribed oral medication to the patient and observe the patient take the oral medications into their mouth and swallow all pills followed by an adequate amount of water.  The patient shall remain clearly visible to health care staff.

      • Licensed health care staff, with assistance from custody staff as needed, shall verify that the patient swallowed the medications by completing a visual mouth check, viewing the empty cup, and other checks as indicated.

      • If staff cannot verify that the patient swallowed the medication and followed all steps of the above procedure, licensed health care staff shall request that custody staff escort the patient to an area with clear visibility where medication administration can be verified.

    • Orders for DOT administration of medications that are not required per pharmacy policy to be DOT shall have clinical justification for DOT documented in the health record.  Before determining the means of administration, the provider shall consider the following:

      • Potential for self-harm.

      • Potential for diversion.

      • History of non-compliance or overdosing.

      • Problems with medication adherence.

      • Recent history (within the past year) of suicidal ideation, threats, or attempts.

    • “Crush/Open and Float” Requirements

      • It is the policy of California Correctional Health Care Services to administer oral medications with significant potential for diversion as “crush/open and float” when product formulation permits. The Systemwide P&T Committee shall maintain the current list of such medications.

      • Strict adherence to this policy is required from all licensed health care staff administering “crush/open and float” medications.

    • DOT Procedure for Sublingual DEA Controlled Substances

      • The patient shall present to the medication line (GP) or the cell front (restricted housing units) with a cup of water and remove any mask or face covering.

      • Licensed health care staff administering medication shall verify the patient’s identity and use the “Six Rights” of medication administration by following the steps outlined in Section (c)(1)(F).

      • Licensed health care staff shall administer the sublingual DEA controlled substance after all other prescribed medications have been taken.

      • Licensed health care staff administering medication shall have the patient wet their mouth with a small drink of water before administration.

      • Licensed health care staff shall observe the patient take the sublingual DEA controlled substance into their mouth, and the patient shall be instructed not to chew, swallow, talk, or open their mouth while the medication is dissolving. The patient shall remain clearly visible to health care staff.

      • Once the medication is administered, licensed health care staff shall provide face-to-face patient education or instruction to ensure initiation of the dissolution process over the recommended observation time.

      • Observation of the sublingual medication (e.g., buprenorphine-naloxone sublingual film) entering the mouth and completion of the face-to-face education or instruction to initiate dissolution as outlined shall satisfy the verification of administration as required by the DOT procedure in Section (c)(5)(A)2.

  • Nurse Administered (NA)

    • NA is required for patients:

      • Who cannot safely or properly self-administer medications.

      • Who are receiving medications required by policy to be NA.

      • Whenever specified by the prescriber.

    • NA Procedure

      • The patient shall present to the medication line (GP) or the cell front (restricted housing units) with a cup of water and remove any mask or face covering.

      • Licensed health care staff administering the medication shall verify the patient’s identity and use the “Six Rights” of medication administration by following the steps outlined in Section (c)(1)(F).

      • The licensed health care staff shall give the medication to the patient, observe the patient take the oral medications into their mouth followed by an adequate amount of water and swallow all pills. The patient shall remain clearly visible to health care staff.

      • If staff cannot verify that the patient swallowed the medication and followed all steps of the above procedure, licensed health care staff shall request that custody staff escort the patient to an area with clear visibility where medication administration can be verified.

  • KOP: Self-Administered

    • Patients receiving prescribed KOP medications shall be able to produce a valid current label for each medication.

    • All inhalers shall be refilled on a one-to-one exchange basis. If the patient does not return their inhaler, a new inhaler shall be issued and custody shall be notified for assistance in locating the missing inhaler.

    • Patients shall be notified that their KOP medications are available for pick up at the medication window. Notification methods may include:

      • Posting the KOP Ready List at the clinic for patients whose KOP medications are available for pick up.

      • A verbal notification to the patient.

      • Contacting the housing officer to announce that the patient should report to the medication line.

      • Providing a KOP Ready List to the program offices for distribution to the housing units.

      • KOP medications for patients in restricted housing units shall be delivered during medication administration rounds in accordance with their LOP.

    • In the event a patient does not pick up the KOP medications within four business days of the medication becoming available, the licensed health care staff shall utilize the institution’s established process in accordance with their LOP to ensure the patient reports to the medication line to accept or refuse the medication. These processes may include:

      • Ducating the patient to the medication line.

      • Notifying custody staff to have the patient escorted to the medication line.

    • Documentation on the MAW or MAR shall indicate patient receipt or refusal of the KOP medication.

      • Medication administration.

      • Documentation of barriers that prevented the patient from presenting to the medication line.

    • Patients who refuse KOP medications shall be referred to the prescribing provider for appropriate management.

  • Parenteral Medications

    • Licensed health care staff shall record the route of administration and injection site on the MAW or MAR. The MAW or MAR shall include the following:

      • Patient name

      • CDCR number

      • Prescription number

      • Date, time, and signature of the licensed health care staff administering the medication

      • Injection site

    • Parenteral medications shall not be administered through the food port or cell bars.  If a patient requires medication to be administered by injection and self-administered injection as referenced in (c)(6)(D)(4) below has not been approved, custody staff shall have the patient escorted to an injection room or clinical space in the housing unit (if available) or to the clinic where the licensed health care staff can safely administer the medication. If these options are not available, custody staff shall escort the patient from the cell to a safe and appropriate location as designated by the CEO and Warden.

    • Injections shall be drawn at the time of administration.  In the case of mass vaccination campaigns, a small quantity of the injections may be pre-drawn no more than one hour prior to administration.  Each licensed health care staff may draw a small quantity of vaccine to meet the initial needs of the clinic, but no more than can be administered in one hour.

    • Self-Administered Injections

      • After demonstrating self-injection skills, patients on insulin may self-inject while under close observation by a licensed nurse. Nursing staff shall prepare the insulin for administration, observe the injection, and record on the MAW or MAR.

      • After administration, custody staff shall observe the patient placing any needles and syringes directly into the sharps container.

      • Patients shall never self-inject DEA controlled substances.

    • Injectable DEA Controlled Substances

      • Consider using when medication adherence or misuse concerns exist (e.g., cheeking, diversion).

      • Prior to considering injectable DEA controlled substances for a patient, health care staff shall:

        • Conduct an investigation to understand the facts of the suspicion,

        • Meet with the patient,

        • Seek case consultation through use of Care Team Education Conferences,

        • Consider alternative medication types via existing procedures, and

        • Document the outcome of the above steps in a progress note in the health record.

    • Infusions

      • Infusions shall occur in specialized beds (e.g., CTC, SNF, Outpatient Housing Unit, Triage and Treatment Area, Hospice) or other areas with approval by the Systemwide Medication Management Subcommittee.

      • Intravenous therapy shall only be conducted by authorized staff in accordance with licensure and scope of practice.

      • Whenever possible, closed systems (e.g., ADD-Vantage, Mini-Bag plus) should be used. Intravenous medication prepared at bedside shall be administered according to manufacturer’s recommendations as close to the administration time as possible within the standards from USP General Chapter <797>, federal and state regulations, etc.

      • If unavailable, the intravenous medication may be ordered and prepared by a state-contracted sterile compounding vendor.

  • Administration of medications by a contracted narcotic treatment program (NTP)

    • The contracted NTP shall:

      • Supply patient-specific medications.

      • Administer patient-specific medications.

      • Record the administration and submit the medication administration record to the designated health care staff.

    • The health care staff member shall forward the record to HIM to scan into the health record.

• Involuntary Medication Administration

  • Emergency medication may be administered to a patient who cannot or does not consent, without obtaining a court order, in response to a life-threatening medical or psychiatric emergency. Emergency medications shall only be ordered per episode and for only as long as the emergency exists. In such cases, immediate intervention may be necessary for the safety of the patient or others.

  • Involuntary psychiatric medications may be continued beyond 72 hours by filing a petition for involuntary treatment. This requires an ex-parte order that allows that medications be continued beyond 72 hours.

  • In most cases, patients comply with the court order and take medications without incident. Such administration is expected to be completed with the least reliance on force.

    • PC 2602

      • Certain patients are under court order to receive involuntary administration of mental health medications.

      • Medications ordered under PC 2602 are administered NA (for injectable medications) or DOT (for oral medications).

      • The PC 2602 Coordinator shall forward a list of all patients under PC 2602 orders to designated personnel.

    • The provider shall denote PC 2602 on the medication order such that the licensed health care staff administering medications is aware of those patients under court order for involuntary medication administration.

    • PC 2604

      • In rare circumstances, there may be a patient for whom a court order has been issued for involuntary medical treatment which may include medications.

      • Medications ordered under PC 2604 are administered NA (for injectable medications) or DOT (for oral medications).

      • Institution medical management shall inform designated personnel of patients with PC 2604 orders.

  • In situations where a patient refuses their court-ordered regularly scheduled medication (under PC 2602 or PC 2604), backup medications may need to be administered. This may, after clinical supervisory review, require a controlled use of force team to enter the cell, physically restrain the patient while medications or treatment are administered, and exit the cell with the least reliance on force. In these cases, all of the requirements of controlled use of force pursuant to the CDCR, Department Operations Manual, Sections 51020.12 Controlled Use of Force General Requirements and 51020.12.4 Controlled Use of Force in Health Care Facilities, and efforts by clinical and custody staff to talk the individual into complying with the medication order remain in effect.

Procedure Overview

• This procedure provides guidelines for the monitoring and reporting of patient medication adherence issues. Parameters vary by administration type (Keep-On-Person [KOP], Nurse Administered [NA], and Directly Observed Therapy [DOT]) and by its reporting status (immediate or over time).

Responsibility

• Statewide

  • California Correctional Health Care Services (CCHCS) and California Department of Corrections and Rehabilitation (CDCR) departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available so that licensed health care staff can successfully implement this procedure.

• Regional

  • Regional Health Care Executives are responsible for implementation of this procedure at the subset of institutions within an assigned region.

• Institutional

  • The Chief Executive Officer, or designee, is responsible for the administration, monitoring, and evaluation of the compliance with this procedure at the institution level.

Procedure

• Auto-refill Process

  • When feasible and clinically appropriate, regularly scheduled doses of KOP medications shall be automatically refilled to encourage patient adherence and to maintain continuity of care.

  • At any time, a patient may request the discontinuation of the auto-refill process for one or more medications by submitting a CDCR 7362, Health Care Services Request Form, or by discussing with their provider.

• Critical Adherence Medication List

  • Each year, the Systemwide Pharmacy and Therapeutics Committee, in collaboration with the Statewide Patient Safety Committee, shall release a Critical Adherence Medication List with corresponding interventions. While adherence is important for all medications, missing a single dose for one of the selected critical medications carries a higher risk.

  • Medications that are part of involuntary treatment court orders (i.e., Penal Code [PC] 2602 and PC 2604) shall be included in the Critical Adherence Medication List.

  • Medications on the Critical Adherence Medication List shall be programmed in the Electronic Health Record System (EHRS) to alert the prescriber and the patient’s Primary Care Team (PCT) for timely intervention.

  • The Critical Adherence Medication List is available on Lifeline and the CCHCS and CDCR publicly accessible websites.

• Medication Administration Record

  • An automated flag to the Huddle Report shall notify all members of the patient’s PCT if the patient misses:

    • Three consecutive days of a scheduled NA or DOT medication;

    • 50 percent or more of scheduled doses over seven consecutive days of an NA or DOT order; or

    • A single dose of a medication on the Critical Adherence Medication List.

  • If an alert generated in Section (c)(3)(A) is due to a medication ordered by a dentist, the PCT shall notify the prescribing dentist and assigned dentist via the EHRS Message Center.

  • In addition, an automated flag to the Huddle Report and a message sent via the EHRS Message Center by the PCT shall notify the mental health prescriber (defined as a psychiatrist or psychiatric nurse practitioner acting under the supervision of a psychiatrist) if the patient misses:

    • Three consecutive days of a non-critical psychiatric medication;

    • 50 percent or more of scheduled doses of a psychiatric medication over seven consecutive days; or

    • A single dose of a medication on the Critical Adherence Medication List.

  • A designated nursing supervisor shall review the compliance of medication administration utilizing dashboards, master registries, patient summaries, and decision support tools to address or elevate issues concerning medication adherence as necessary.

• Medication No-Shows for Medication Lines (Medication Administration)

  • At the conclusion of each medication line, licensed nursing staff shall access the Post Medline Report located in PowerChart to identify patients who did not present to the medication line to receive their scheduled medications (no-shows) or other medication administration problems.  The only exception to this will be those patients with PRN (as needed) medications.

  • If the patient is a no-show for an NA or DOT medication, licensed nursing staff shall coordinate with the nursing supervisor, Facility Captain, Lieutenant, Sergeant, or Associate Warden, Health Care Services, to locate the patient and to assist with resolving any identified barriers to medication administration as appropriate, and make every effort to bring the patient to the medication line for:

    • Medication administration; and

    • Documentation of barriers that prevented the patient from presenting to the medication line (e.g., lockdowns or transfers to another area or institution); or

    • Documentation of their refusal and reason for refusal of the medication.

• Medication Refusals

  • Licensed nursing staff shall document each refusal of an NA or DOT medication in the EHRS Medication Administration Wizard or electronic Medication Administration Record and document the reason for each medication refused, as stated by the patient.

    • If a patient refuses methadone administration by the Narcotic Treatment Program, licensed nursing staff shall have the patient sign a CDCR 7225, Refusal of Examination and/or Treatment.  The Addiction Medicine Central Team and the patient’s PCT shall be notified via the EHRS Message Pool.

  • Licensed nursing staff shall notify the prescriber when the patient refuses to pick up KOP medication, provide medication adherence counseling as determined by the prescriber, and document in the health record.

  • Prescribers shall consider changing prescriptions, discontinuing medications, or discontinuing auto-refill for medication refusals and document the rationale for the action in the health record.

• Medication Non-Adherence Counseling

  • Any prescribers and other licensed health care staff conducting patient interviews or education shall ensure that effective communication is provided and documented in the health record.

  • Medication adherence issues shall also be documented on the problem list.

  • Clinical health care staff shall review medication adherence by way of the Automated Huddle Report or EHRS Message Pool for licensed health care staff to perform medication counseling.

  • Patients prescribed medications by a medical prescriber:

    • For critical medications on the Critical Adherence Medications List, the prescriber, or designated backup, shall be notified verbally and in writing when a patient misses a critical medication by the end of the medication pass.  Patients shall be seen by licensed health care staff within 24 hours when referred for missing or refusing a dose of a critical medication.

    • For non-critical medications, licensed health care staff shall provide medication adherence counseling as determined by the PCT and document in the health record.  When indicated, licensed health care staff shall contact the prescriber for guidance.

  • Patients prescribed psychiatric medications by a mental health prescriber:

    • For medications on the Critical Adherence Medication List, the patient shall be seen by a mental health prescriber, or designated backup, for an urgent mental health referral within 24 hours from receipt of the notification of medication non-adherence.

    • For non-critical medications, a mental health prescriber shall review the health record and document in the health record the plan of action within seven calendar days from receipt of the notification of medication non-adherence.

      • The documented plan of action should take into account anticipated future medication non-adherence.

      • A mental health prescriber shall follow up with a face-to-face session addressing the medication non-adherence as soon as clinically indicated, but no longer than 30 calendar days from the first day the mental health prescriber is notified of non-adherence.

    • Any medication adherence counseling session with a mental health prescriber shall be documented in a detailed note, and shall take place in a confidential setting, unless the patient refuses to attend.

  • If the patient refuses life-sustaining medications, the prescriber shall assess the patient’s decision-making capacity and document in the health record.

    • If the patient has significant mental illness, it may be necessary to seek assistance from a psychiatric physician regarding the patient’s decision-making capacity.

    • If a mental health referral is needed, the Primary Care Provider shall make a referral to the psychiatric physician for a determination of capacity to refuse treatment and inform the patient of the reason for the referral.

  • The prescriber may discontinue the medication and have the patient sign a CDCR 7225 when a patient who has decision-making capacity continues to refuse medication.

    • For adherence issues with Medication Assisted Treatment medications, prior to discontinuing the medication licensed health care staff shall:

      • Meet with the patient to discuss the concerns;

      • Seek case consultation from the CCHCS Complex Care Team at CCHCSComplexCare@cdcr.ca.gov;

      • Consider alternative medication types (including injectable medications) via existing procedures; and

      • Document the outcome of the above steps in a progress note in EHRS.

  • All refusals shall be signed by the patient and co-signed by licensed health care staff.  If the patient refuses to sign the CDCR 7225, two licensed health care staff shall sign.  In unusual circumstances (e.g., Administrative Segregation Unit, Mental Health Crisis Bed), the CDCR 7225 may be signed by two staff members, one of whom shall be a licensed health care staff.

  • When a refusal is signed, the original refusal form shall be forwarded to Health Information Management to be scanned to the health record.

• Hoarding, Cheeking, or Medication Misuse

  • Medication issues that involve a security or safety issue (e.g., hoarding or diverting of medications) shall be referred to the prescriber via the EHRS Message Center and the appropriate Facility Lieutenant, or designee, shall be notified.

  • Upon notification, the prescriber shall evaluate the need for a modification to the medication regimen (such as discontinuing medication, requiring “crush and float,” changing to NA or DOT) and schedule an appointment with the patient as clinically appropriate.

    • For suspected misuse of medications, prior to modifying or discontinuing the medication, licensed health care staff shall:

      • Conduct an assessment to understand the facts;

      • Meet with the patient to discuss the importance of taking medications as prescribed;

      • Seek case consultation, as needed, based on patient need and circumstances;

      • Consider alternative medication types (e.g., injectable medications) via existing procedures; and

      • Document the outcome of the above steps in a progress note in EHRS.

  • Prescribers shall take necessary action regarding the patient’s prescribed medication based on information provided and subsequent patient evaluation.

  • Prescribers shall notify the Pharmacist-In-Charge of medication misuse.

Procedure Overview

• Incarcerated persons are not authorized to possess any medications that meet the criteria identified in this policy.  Unauthorized medications shall be confiscated and returned to health care staff unless there is a possibility of a disciplinary charge.  The confiscated medications shall be disposed of or sent to the pharmacy for identification if needed.

Purpose

• To provide guidance to custody and health care staff regarding confiscation of medications.

Procedure

• The following medications shall be confiscated:

  • Prescription medications found outside of an approved medication container (e.g., unlabeled container).  Approved medication containers shall bear a California Correctional Health Care Services pharmacy label which lists:

    • Patient name.

    • California Department of Corrections and Rehabilitation number.

    • Name of the medication as well as strength, dosing instructions, and quantity supplied.

    • Order expiration date of the medication.

  • Medications for which the prescription is past the order expiration date on the label.

  • A mixture of medications in any labeled or unlabeled container.

  • Prescription medications which are not prescribed to the incarcerated person.

  • Unauthorized medications from an outside source.

  • Over-the-counter medications not in consumer-ready packaging or otherwise properly labeled by pharmacy.

  • Any medications which are expired and/or adulterated.

  • Medications not used as prescribed, for example:

    • Medications passed to other incarcerated persons.

    • Alterations of an inhaler or other medication container.

    • Hoarded.

    • Crushed or altered.

• Chain of Custody for Confiscated Medications

  • When medications are confiscated, except as described below in Section (c)(2)(A)1., custody staff shall place the medication in an unsealed envelope containing cell search receipts, label the envelope as “confiscated medication,” and deliver to nursing staff.  Nursing staff shall examine the contents, notify the prescriber of the incident within the same shift, and dispose of the medication. If identification of the medication is necessary, nursing staff shall seal the contents in the envelope under custody observation to send to the pharmacy for identification and disposition.

    • When there is a possibility of a disciplinary charge (including referrals for criminal prosecution), custody staff shall maintain possession of medications to preserve the chain of evidence only allowing for examination of the substance by pharmacy staff to the degree necessary for positive identification.

    • Upon request, pharmacists shall assist in the identification of intact medications for the purposes of internal investigations.

  • Follow-up physician orders shall be documented in the health record.

  • The on-duty nursing supervisor shall be contacted for further direction if there are any immediate concerns regarding confiscated medications.

  • Nursing staff may return confiscated medications to the patient if all of the following criteria are met:

    • The medication was found in an approved container as outlined in the Section (c)(1)(A).

    • The contents of the container were verified by a pharmacist to be accurate according to the label on the container.

    • The medication is neither expired nor adulterated.

    • There is an active order in the health record for the medication.

    • There is no evidence of hoarding.

• Disposition of Medications

  • Confiscated medications shall be disposed of in compliance with the Health Care Department Operations Manual, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

  • Illegal drugs shall not be taken to medical or pharmacy for disposal but shall remain within custody control.  The internal investigation authority shall direct disposition of illegal drugs pursuant to the Department Operations Manual, Sections 52010.24, 52010.25, and 52010.26.

Policy

• California Correctional Health Care Services (CCHCS) shall comply with all requirements and restrictions of Section 340B of the Public Health Service Act and any accompanying regulations or guidelines including, but not limited to, the prohibition against duplicate discounts or rebates under Medicaid and the prohibition against transferring drugs purchased under 340B to anyone other than an eligible patient of the entity. In accordance with the program’s intent, the savings generated from participation in the 340B Program shall be used to expand health care services for the incarcerated population including linkage to care upon release.  CCHCS shall maintain written policies and procedures that outline the 340B Program operations and systems, mechanisms, and internal controls demonstrating compliance with the 340B Program, and the Systemwide Pharmacy and Therapeutics (P&T) Committee shall review these reports at least quarterly as part of its 340B oversight and compliance program.

Purpose

• To outline and to operate a compliant 340B program.

Responsibility

• The Deputy Director, Medical Services shall:

  • Act as the Authorizing Official for each institution.

  • Oversee the compliance and administration of the program within each institution.

  • Attest to the compliance of the program through annual recertification.

  • Administer the 340B Program to fully implement and optimize appropriate savings.

  • Ensure that current policy statements and procedures are in place to maintain program compliance.

  • Maintain knowledge of the policy changes that affect the 340B Program including, but not limited to, Health Resources and Services Administration (HRSA) rules and Medicaid changes.

  • Monitor any changes in each institution’s eligibility or other pertinent information.

• The Statewide Chief of Pharmacy Services shall:

  • Act as the Primary Contact to receive communications from the HRSA regarding the covered entity’s status.

  • Assist the Authorizing Official with attesting to the compliance of the 340B Program through recertification.

  • In collaboration with CCHCS Fiscal Management Section, account for total savings from the use of the 340B Program and communicate savings to extend health care services for the incarcerated population to the California Department of Public Health (CDPH) Sexually Transmitted Diseases (STD) Control Branch corrections liaison.

  • Review and refine a 340B cost-savings report that details purchasing, replacement practices, and dispensing patterns.

  • Oversee daily operations of the 340B Program, as performed by the 340B Central Team, by:

    • Maintaining and testing of tracking software.

    • Drafting policies and procedures.

    • Maintaining system databases to reflect changes in the drug formulary or product specifications.

    • Managing purchasing, receiving, and inventory control processes.

    • Continually balancing product availability and cost-efficient inventory control within 340B purchases.

    • Ensuring appropriate safeguards and system integrity.

    • Ensuring compliance with 340B Program requirements for eligible patients, drugs, providers, vendors, payers, and locations.

    • Monitoring ordering processes, integrating most current pricing from wholesaler, analyzing invoices, shipping, and inventory processes.

• The 340B Central Team shall perform the day-to-day processes to operate the 340B Program including, but not limited to:

  • Validating patient eligibility for the 340B Program.

  • Reordering a replenishment supply of medications through the pharmacy’s 340B account based on its dispense and administration records for eligible patients.

• The Systemwide P&T Committee shall:

  • Have oversight of the 340B Program and shall serve or appoint a subcommittee known as the 340B Oversight Subcommittee.

  • Review 340B rules, regulations, and guidelines to ensure consistent participation in accordance with 340B requirements.

  • Conduct necessary reviews for 340B Program compliance at least quarterly and:

    • Ensure that the organization meets compliance requirements related to program eligibility, patient definitions, 340B drug diversion, and duplicate discounts via ongoing multidisciplinary teamwork.

    • Integrate departments such as information technology, legal, pharmacy, compliance, and fiscal services to develop standard processes for contract and data review to ensure program compliance.

  • Oversee the review process of compliance activities, as well as take corrective actions based on findings.

  • Approve which therapeutic categories and National Drug Codes (NDCs) shall be part of CCHCS’ 340B replenishment program.

  • Be notified of a material breach.

  • Review and approve recommendations, including process changes, self-monitoring outcomes, and resolutions.

  • Review and approve new programs and initiatives funded through savings from the 340B Program.

Procedure

• Eligibility for the 340B Program

  • Each covered entity is a subgrantee via in-kind support from the CDPH STD Control Branch.

  • CCHCS shall maintain auditable records, policies, and procedures related to the definition of covered outpatient drug that is consistent with the 340B statute and Social Security Act.

  • Each covered entity shall annually recertify their eligibility to remain in the 340B Drug Pricing Program and update information as needed on the 340B Office of Pharmacy Affairs Information System (OPAIS).

  • For an individual to receive a 340B medication, the covered entity must meet the following requirements for the definition of an eligible patient by the HRSA:

    • The covered entity must maintain records of the individual’s health care.

    • The individual must be under the care of a physician or other health care professional who is employed by, under contract with, or in a referral relationship to the covered entity such that responsibility for the individual’s care remains with the covered entity.

    • The individual must receive health care services that are consistent with the services for which in-kind or grant funding has been provided to the covered entity.

• Registration in the 340B Program

  • The Authorizing Official shall:

  • Enroll each covered entity in 340B OPAIS to participate in the 340B Program.

  • Monitor registration dates and deadlines.

  • Update in 340B OPAIS with Authorizing Official and Primary Contact information.

  • Annually recertify each covered entity’s information on 340B OPAIS.

• Changes to CCHCS Information in 340B OPAIS

  • The Authorizing Official shall notify the HRSA promptly of any changes to CCHCS’ information in 340B OPAIS.

  • The Authorizing Official shall notify the HRSA promptly of changes to any covered entity’s grant status.

    • Pharmacies shall stop the purchase of 340B medications as soon as the covered entity loses 340B Program eligibility.

    • The Authorizing Official shall complete the online change request as soon as a change in eligibility is identified.

• Requirements of the Covered Entity

  • Each covered entity must have a copy of the 340B Operations Manual readily retrievable.

  • The CDPH STD Control Branch shall provide in-kind support to each covered entity through:

    • Condoms for patients.

    • Specialized education for providers regarding public health subjects.

  • Each covered entity shall provide health care services to the eligible patients. These services may include, but are not limited to:

    • Opt-out screenings for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), gonorrhea, chlamydia, and syphilis as recommended.

    • Serum pregnancy test for all females under 60 years old.

    • Comprehensive sexual health screening and follow-up counseling and services, where indicated.

    • Substance use disorder counseling and treatment, where indicated.

    • Treatment of any diagnosed sexually transmitted diseases.

    • Human papillomavirus vaccine, where indicated.

    • Access to contraceptives pursuant to the Health Care Department Operations Manual, Section 3.1.15, Access to Contraceptive and Family Planning Services.

    • Condoms upon release.

• Prevention of Duplicate Discounts

  • Institutions shall not seek reimbursement from Medi-Cal for the cost of medications obtained under the 340B Program. Medi-Cal shall not pay for the drug cost of medication prescribed to an incarcerated individual when the medication is obtained under the 340B Program.

• 340B Co-payment and Reimbursement Procedures

  • Initial prescriptions, changes, or renewals of 340B medications shall be exempt from co-payment charges to patients.

  • 340B purchased medications shall only be eligible for return to the 340B account.

• 340B Inventory Procedures

  • The 340B Central Team shall maintain a virtual mixed-use replenishment system for inventory across CCHCS, in which an institution will dispense from non-340B inventory, then the 340B Central Team will purchase from a 340B primary vendor a replenishment supply only upon verification of patients’ 340B eligibility.

  • Pharmacy inventory shall be replenished at the 11-digit NDC level as standard practice. In exceptional circumstances, when 11-digit replenishment is not possible, the inventory may be replenished at the 9-digit NDC level with auditable records demonstrating that the appropriate amounts are replenished from the same manufacturer, regardless of the package size.

  • The 340B Central Team shall identify and oversee separate 340B accounts for each institution used for purchasing drugs.

  • The 340B Central Team shall perform routine replenishment based on reports generated from administrations and dispenses for 340B eligible patients at each institution.

  • Inventory replenishment with 340B medications shall not occur for patients in an inpatient setting. Medications needed in a licensed unit (e.g., Correctional Treatment Center, Mental Health Crisis Bed) shall come from non-340B inventory.

  • 340B replenishment products shall be directly shipped from the vendor to the pharmacy at the institution or the contract pharmacy in which the enrolled patient utilized the medication.

  • The pharmacy at the institution shall verify quantity received with quantity ordered. The pharmacy shall identify, resolve, and document resolution of any inaccuracies.

  • The covered entity shall maintain records of 340B-related transactions for three years in a readily retrievable and auditable format.

• Diversion Prevention Procedures for 340B-Priced Medications

  • Each covered entity shall maintain a separate wholesaler ordering account for 340B-priced medications.

  • The Systemwide P&T Committee, through the 340B Oversight Subcommittee, will approve which medication therapeutic categories are covered in the 340B Program.

  • Patients eligible for the 340B Program shall have documented at least one of the following criteria:

    • The patient has a diagnosis of HIV.

    • The patient has a diagnosis or history of HBV or HCV.

    • The patient has a diagnosis or history that includes an STD.

    • The patient has self-reported or has been discovered to partake in high-risk activities (e.g., recent or active substance use disorder, men who have sex with men [MSM], or recent history of multiple sexual partners).

  • The treating provider shall  be employed or contracted by the covered entity.

  • Records demonstrating eligibility for 340B-priced medication shall be stored in the health record of the patients receiving a qualifying medication and available to query in the event of an audit.

  • The pharmacy at the institution shall maintain records of 340B-priced product orders, inventory, and return of unused supply.

  • The 340B Central Team shall validate eligibility before replenishing any 340B medication by verifying the receipt of STD screening, prevention, counseling, or treatment in the health record in alignment with federal STD guidelines.

  • Data regarding the eligible purchasing and dispensing of 340B medications shall be maintained in the pharmacy medication database.

  • Pharmacists shall receive 340B replenishment medications at the institution pursuant to Section (d)(7), 340B inventory procedures.

  • Pharmacies shall report significant discrepancies (excessive quantities based on utilization or product shortages) to the 340B Central Team within 24 hours of identification of the discrepancy.

  • Quarterly reports relating to the 340B program including updates, audits, and overages, shall be reviewed by the 340B Oversight Subcommittee as part of the Systemwide P&T Committee oversight and compliance program.

• Wasted 340B Medication

  • The 340B Central Team shall review:

  • Previous dispenses or administrations to ensure replenishment is not made for wasted or lost medications by health care staff before ordering a replenishment supply.

  • Documentation and previous dispenses before ordering a replenishment supply of medications that had been lost by a patient and required an early refill.

• 340B Noncompliance and Material Breach

  • CCHCS has defined an established threshold of what constitutes a material breach of the 340B Program as non-compliance greater than five percent of 340B purchases.

  • CCHCS shall ensure that identification of any threshold variation occurs among all its facilities.

  • The Systemwide P&T Committee shall assess the materiality of the dispensing and replenishment records of 340B-priced medications on at least a quarterly basis.

  • The pharmacy at each institution and the 340B Central Team shall maintain records of inventory and ensure 340B-priced medications are only replenished for eligible patients.

  • In the event that a material breach occurs, upon discovery, the Authorizing Official, or designee, shall:

    • Notify the HRSA and follow their instructions regarding the Self-Disclosure Process.

    • Contact Apexus Answers for any additional guidance.

    • Notify the manufacturer(s) involved.

    • Coordinate repayment to the manufacturer by:

      • Requesting preferred method or repayment with receipt requested mail.

      • Sending a second notice if there is not a response in 90 days.

      • Repaying the negotiated repayment amount to the manufacturer.

      • Retaining a copy of all communications and a signed and dated overview of all relevant conversations related to the material breach.

  • The Authorizing Official, or designee, shall maintain records of material breach violations, including manufacturer resolution correspondence.

  • In the event that a finding does not meet the requirements of a material breach, but could lead to a material breach if not corrected, a corrective action plan (CAP) shall be created and filed with the Systemwide P&T Committee. If the CAP requires a policy change, that must also be reported to the Statewide Chief of Pharmacy Services. The CAP should be implemented as soon as possible to prevent future potential material breaches.

• 340B Program Compliance Monitoring and Reporting

  • The Systemwide P&T Committee shall review the results of an internal audit, conducted at least annually by an audit team approved by the Committee, to ensure the integrity of the 340B Program.

  • The covered entity’s 340B Authorizing Official shall review 340B OPAIS to ensure the accuracy of the information for each covered entity.

  • The 340B Central Team shall reconcile purchasing and dispensing records to ensure that covered outpatient drugs purchased through the 340B Program are replenished only for patients eligible to receive 340B medications and that variances are not the result of diversion.

  • The Authorizing Official shall ensure quarterly that each facility audit consists of five percent of the qualified 340B prescriptions administered or dispensed or up to five prescriptions, whichever is greater.

  • The monitoring process shall review that three years of 340B-related transaction records are readily retrievable and auditable.