The Victoria Pharmacy Authority (VPA) has revealed that …a disturbing number of pharmacists continue to ignore requirements for secure storage and maintenance of accurate records for Schedule 8 poisons.
At its August meeting the Authority reaffirmed its prior decision to convene Panel Hearings following cases of alleged serious breaches of Schedule 8 poisons legislation (VPA Communique, 21 August 2015).
Pharmacists who are not complying with the record keeping and storage requirements set out in the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) can expect the VPA to take administrative disciplinary action if such non-compliance is identified during a VPA inspection. The Department of Health and Human Services, Drugs and Poisons Unit (DPU) can also commence criminal proceedings for a breach of these obligations.
Meridian Lawyers has assisted a number of practitioners subjected to such administrative or criminal proceedings. This alert outlines the three main regulations of the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) that are commonly misunderstood/not complied with.
- Regulation 36 – Schedule 8 poisons in a pharmacist’s possession must be stored in a lockable room or a lockable storage facility that is firmly fixed to a floor or wall. Further, pharmacists must take reasonable steps to ensure Schedule 8 poisons remain locked and secured to prevent access by an unauthorised person at all times, except when it is necessary to open them to carry out an essential operation in connection with the poisons stored in them. This means that pharmacists must not only have an appropriate room or safe, but also ensure the keys to that room or safe are kept secure.
- Regulation 41(1)(b) – A pharmacist must ensure the records of all Schedule 8 transactions (which includes manufacture, preparation, use, transfer within and between premises, administration, sale, supply, disposal or destruction) show the true and accurate balance of each Schedule 8 poison remaining in that pharmacy’s possession after each transaction. That is to say, the records must always reflect the physical balance in the pharmacy’s Schedule 8 room/safe. It is not sufficient for the records to reflect what the balance should be. Records of transaction must be made as soon as practicable after each transaction. The DPU and VPA expect pharmacists to regularly reconcile their Schedule 8 records with the stock on hand (this includes regularly checking stock on hand and outgoing stock against the records of incoming stock).
- Regulation 43 – A pharmacist must investigate without delay any discrepancies in the transaction records kept by that person; and after that investigation, notify the Secretary (DPU) without delay of any discrepancy that remains. As records must be made as soon as practicable after each transaction and reflect the physical balance, discrepancies should be identified at the earliest possible time. The investigation of a discrepancy must occur immediately and any notification must similarly occur immediately. If the discrepancy is resolved, a record of what caused the discrepancy should be kept for future reference (and audit purposes).
Pharmacists are reminded that these obligations apply equally to returned Schedule 8 medications and Opioid Replacement Therapy medications.
We urge pharmacists to review:
- the Drugs, Poisons and Controlled Substances Act 1981 (Vic)
- the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic)
- the Department of Health and Human Services publication “Management and storage of Schedule 8 poisons”, which can be accessed at: http://www.health.vic.gov.au/dpcs/reqhealth.htm
- section 4.5 of the VPA Guidelines 2015, which can be accessed at: http://www.pharmacy.vic.gov.au/index.php?view=guidelines&item=0
Please contact Principal Kellie Dell’Oro for more information.
This information is current as of September 2015. This article does not constitute legal advice. It does not give rise to any solicitor/client relationship between Meridian Lawyers and the reader. Professional legal advice should be sought before acting or relying upon the content of this article.