Controlled Substances Pharmacy Learning Objectives Upon completion of

Controlled Substances Pharmacy

Learning Objectives • Upon completion of this module, you will – Understand your responsibilities when handling controlled substances – Identify the proper procedure for receiving controlled substances in the pharmacy – Understand the record-keeping requirements for controlled substances – Identify the steps for proper dispensing of controlled substances – Understand how controlled substances are wasted/returned. – Understand how to document/report a controlled substance discrepancy 2

Controlled Substance Policy The Department of Pharmacy will maintain a perpetual inventory system for all scheduled drugs. The Department of Pharmacy will maintain all controlled substances in accordance with all applicable state and federal laws. These records will be available for inspection by all state and federal regulators All employees must strictly adhere to all laws, regulations and hospital policies and procedures with regard to procurement, distribution, storage, administration, documentation and destruction of prescription drugs and controlled substances. 3

Receipt • Upon receipt of controlled substances, the package is opened and the count, condition, and identification of the drugs are verified by a pharmacist. • For each invoice, the pharmacist will: – Sign – Date – Circle or place a check mark next to each item listed to confirm receipt of the quantity of product • All invoices will be filed chronologically by calendar month. – CII invoices will be filed separately from CIII – CV invoices • Controlled substances will be immediately stored in the locked narcotics vault or in the Secure Vault. • Upon stocking of the controlled substances into the Secure Vault, a stocking receipt will be printed to later be reconciled and attached to the signed and dated invoices. 4

Storage • Within the Department of Pharmacy, controlled substances will be stored in a securely locked, area (Secure Vault). • Access to this area is available only to hospital-employed, California registered pharmacists. – A pharmacy technician assisting in the preparation and dispensing of controlled substances may be granted access to this area. • Controlled Substances kept at the nursing station will be secured in the Omnicell. – The Pharmacy will perform monthly inspections to ensure security of controlled substances. 5

Inventory • A perpetual inventory of all controlled substances will be maintained through the Omnicell CSM. • Each time scheduled drugs are received, dispensed, returned to the pharmacy, or otherwise removed from or added to the inventory, the transaction will be recorded on the perpetual inventory through the ADM, including: • • • Name an strength of the drug Date Amount Area dispensed to or received from Balance on hand will be verified through the CSM • A physical inventory of controlled substances in the pharmacy will be performed monthly by 2 staff members. 6

Dispensing • Controlled substances will be dispensed from the pharmacy to the nursing units through the ADM. – In the event that a controlled substance cannot be stocked in an ADM, such items will be supplied to the nursing station as individual patient doses and must be secured. • Controlled substances will be delivered by pharmacy personnel to the nursing unit and stocked in the Omnicell. • The amount being added to the stock will be verified by a witness who has access to the Omnicell. – Personnel authorized to witness include: pharmacy technicians, pharmacists, physicians, anesthesiologists and licensed nurses. • Individual doses of controlled substances dispensed by the pharmacy will be delivered by authorized pharmacy personnel to the patient care unit. The licensed nurse receiving the dose will sign the delivery form. 7

Expired Controlled Substances A pharmacist will routinely check all ADMs and the ADM narcotic vault for the presence of expired medications. Controlled substances require a witness to remove the expired medication. Expired medication will be removed from the ADM using the “expired/recall” function. Expired controlled substances will be returned to Secure Vault designated expired area and will be recorded through the CSM. • • – Expired CII medications will be stored separately from CIII – CV medications. Expired controlled substances will be transferred to a DEA registered reverse distributor who handles the disposal of controlled substances. • – The pharmacy will compare the controlled substances listed on the DEA Form 222 to the expected list of schedule 2 controlled substances to be transferred. Any discrepancies will be reconciled. – The pharmacy will compare the report of schedule 3 -5 controlled substances on the vendor return report to the expected list of controlled substances to be transferred. Any discrepancies will be reconciled. 8

Monitoring • The Pharmacy Director or designee will monitor, review and evaluate controlled substance usage patterns, individual activity reports, statistical usage reports and discrepancies. • A monthly report of all purchases of controlled substances from all vendors will be compared to the report of the controlled substances stocked in the pharmacy vault. Any discrepancies will be reconciled. 9

Diversion • No prescription drug or controlled substance may be sold, transferred, or otherwise distributed, except as allowed by law, and as authorized by written policy or by the appropriate individual charged with such responsibility. • All employees must strictly adhere to all laws, regulations, and hospital policies & procedures with regard to procurement, distribution, storage, administration, documentation and destruction of prescription drugs and controlled substances. • The hospital has a responsibility to investigate and intervene when there is a report and/or suspicion of drug diversion. The hospital has a multidisciplinary process to respond to reported or suspected diversions. • All employees are expected to report knowledge/suspicion of drug diversion. Employees should report any known or suspected drug diversion incidents to their manager/director. Department Managers/ Directors will notify the Director of Pharmacy or designee for further follow up. • An employee suspected of drug diversion may be placed on administrative suspension while the investigation is in process. 10

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