{"id":1187,"date":"2023-11-28T13:28:28","date_gmt":"2023-11-28T21:28:28","guid":{"rendered":"https:\/\/www.cdcr.ca.gov\/hcdom\/?post_type=dom&#038;p=1187"},"modified":"2025-02-24T14:11:45","modified_gmt":"2025-02-24T22:11:45","slug":"3-5-26-break-in-theft-loss-from-pharmacy-or-medication-storage-areas","status":"publish","type":"dom","link":"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-26-break-in-theft-loss-from-pharmacy-or-medication-storage-areas\/","title":{"rendered":"3.5.26 Break&#8209;In, Theft\/Loss from Pharmacy or Medication Storage Areas"},"content":{"rendered":"\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Procedure Overview<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Purpose<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p><strong>Procedure<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>This procedure applies to:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Discovery of a theft or other loss of medications at the pharmacy or any licensed areas where medications are stored.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The Pharmacist-in-Charge (PIC), or designee, shall be notified immediately by the person discovering the break-in, theft or loss.\u00a0<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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 <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-1-general-administration\/5-1-4-reporting-of-actual-or-suspected-incidents-of-fraud-errors-and-improper-governmental-activities\/\" data-type=\"link\" data-id=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-1-general-administration\/5-1-4-reporting-of-actual-or-suspected-incidents-of-fraud-errors-and-improper-governmental-activities\/\">5.1.4, Reporting of Actual or Suspected Incidents of Fraud, Errors, and Improper Governmental Activities<\/a>.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Drug Enforcement Administration (DEA) controlled substances destroyed as waste requires a witness.  Unwitnessed waste shall be treated as loss.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.\u00a0 Refer to the HCDOM, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-9-dea-schedule-ii-v-controlled-substances\/\">3.5.9, DEA Schedule II-V Controlled Substances<\/a>, for the requirement of an inventory reconciliation of DEA controlled substances.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Notifications<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>California Department of Corrections and Rehabilitation Institutions<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Investigative Services Unit<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Warden<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Chief Executive Officer<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Chief Nurse Executive<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Central Fill Pharmacy (Food and Drug Administration-Licensed Area)<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>California Highway Patrol<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Chief of Pharmacy Services<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Deputy Director, Medical Services<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Business Services, California Correctional Health Care Services (CCHCS), pursuant to HCDOM, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-5-business-services\/5-5-2-building-security-and-access\/\" data-type=\"link\" data-id=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-5-business-services\/5-5-2-building-security-and-access\/\">5.5.2, Building Security and Access<\/a><\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>After pharmacy business hours, the alarm company shall notify the Central Fill Pharmacy\u2019s property management, Business Services, CCHCS, and California Highway Patrol. \u00a0If a break-in is confirmed, Business Services, CCHCS, shall notify the PIC or a pharmacy supervisor at the Central Fill Pharmacy. \u00a0The 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).<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>California State Board of Pharmacy<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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:<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>For tablets, capsules, or other oral medications, 99 dosage units.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>For single-dose injectable medications, lozenges, film (such as oral, buccal, and sublingual), suppositories, or patches, 10 dosage units.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.\u00a0<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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. \u00a0Refer to the Business and Professions Code, Chapter 9, Division 2, Article 6, Section 4104, Licensed Employee, Theft or Impairment: Pharmacy Procedures, for reporting details.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>Drug Enforcement Administration<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>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.\u00a0 The registrant shall also complete and submit an electronic DEA Form 106 within 45 days after discovery of the theft or loss.\u00a0 Electronic DEA Form 106 is available at the following link: <ins><a href=\"https:\/\/apps.deadiversion.usdoj.gov\/TLR\/\">https:\/\/apps.deadiversion.usdoj.gov\/TLR\/<\/a><\/ins>.\u00a0 (Refer to the HCDOM, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-9-dea-schedule-ii-v-controlled-substances\/\">3.5.9, DEA Schedule II-V Controlled Substances<\/a>.)<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.\u00a0 The PIC, or designee, shall make a final written report within 72 hours of the conclusion of the investigation.<\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>The Chief of Pharmacy Services shall request and determine the frequency of supplemental reports if the investigation becomes lengthy.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block\">\n\t\t\t\t\t<p>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.<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p><strong>References<\/strong><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Code of Federal Regulations, Title 21, Chapter II, Part 1301, Section 1301.76, Other Security Controls for Practitioners<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Drug Enforcement Administration Pharmacists Manual, Section IX, Security Requirements<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Business and Professions Code, Division 2, Chapter 9, Article 6, Section 4104, Licensed Employee, Theft or Impairment: Pharmacy Procedures<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Code of Regulations, Title 16, Division 17, Article 2, Section 1715.6, Reporting Drug Loss<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>California Code of Regulations, Title 16, Division 17, Article 2, Section 1715.65, Inventory Activities and Inventory Reconciliation Reports of Controlled Substances<\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Health Care Department Operations Manual, Chapter 3, Article 5, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-9-dea-schedule-ii-v-controlled-substances\/\" data-type=\"link\" data-id=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-3-health-care-operations\/article-5-pharmacy\/3-5-9-dea-schedule-ii-v-controlled-substances\/\">3.5.9, DEA Schedule II-V Controlled Substances<\/a><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Health Care Department Operations Manual, Chapter 5, Article 1, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-1-general-administration\/5-1-4-reporting-of-actual-or-suspected-incidents-of-fraud-errors-and-improper-governmental-activities\/\" data-type=\"link\" data-id=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-1-general-administration\/5-1-4-reporting-of-actual-or-suspected-incidents-of-fraud-errors-and-improper-governmental-activities\/\">5.1.4, Reporting of Actual or Suspected Incidents of Fraud, Errors, and Improper Governmental Activities<\/a><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-bullet\">\n\t\t\t\t\t<p>Health Care Department Operations Manual, Chapter 5, Article 5, Section <a href=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-5-business-services\/5-5-2-building-security-and-access\/\" data-type=\"link\" data-id=\"https:\/\/www.cdcr.ca.gov\/hcdom\/dom\/chapter-5-administrative\/article-5-business-services\/5-5-2-building-security-and-access\/\">5.5.2, Building Security and Access<\/a><\/p>\n\t\t\t\t\t<\/li>\n\t\n\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p><strong>Revision History<\/strong><\/p>\n\t\t\t\t\n\t<ul class=\"cdcr-dom-group-block\">\n\t\t\n\t<li class=\"cdcr-dom-item-block is-style-no-marker\">\n\t\t\t\t\t<p>Effective: 05\/2008<br>Revised: 02\/24\/2025<\/p>\n\t\t\t\t\t<\/li>\n\t\n\t<\/ul>\n\t\n\t<\/li>\n\t\n\t<\/ul>\n\t","protected":false},"parent":547,"template":"","class_list":["post-1187","dom","type-dom","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>3.5.26 Break-In, 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