The Victorian Pharmacy Authority has reported on three recent panel hearings, one of which featured “extensive” S8 records discrepancies
In one case, “discrepancies in records for S8 poisons were so extensive that the S8 poisons register bore no resemblance to the actual stock on hand,” the VPA observed.
“The key to the S8 poisons safe was not stored securely overnight and methadone working stock was not stored in a clearly labelled bottle.
“There was an incomplete perimeter wall leading to another part of the tenancy. Dispensed medicines were transferred from the dispensary to the cash and wrap counter in open baskets. Current editions of several mandatory references were not maintained.
“The licensees were reprimanded and a condition imposed on their licences requiring submission of quarterly pharmacy self-audits to the Authority.
“The panel also required the licensees to submit a procedure for the management of S8 poisons at the pharmacy and a completed pharmacotherapy self-assessment using the Pharmacotherapy self-assessment form issued by [the Department of Health and Human Services, Medicines and Poisons Regulation].”
A second hearing looked at a case where there were discrepancies in records for S8 poisons, and where dispensed medicines were transferred from the dispensary to the cash and wrap counter in open baskets in breach of the Act, which requires arrangements to ensure clients of the pharmacy cannot identify other clients’ medicines.
“Current editions of several mandatory references were not maintained. The S8 poisons safe was not covered by an alarm sensor in accordance with the Guidelines,” the VPA says.
“The corporate licensee was cautioned and the panel required a copy of a written procedure for the management of S8 poisons at the pharmacy.”
A third hearing concerned inadequate air conditioning, among other issues – again, including discrepancies in records for S8 poisons.
“The pharmacy was not fitted with air-conditioning sufficient to maintain temperatures at or below 25°C at all times in accordance with VPA Guidelines,” says the VPA.
“There were discrepancies in records for S8 poisons and records were maintained in loose-leaf pages rather than in a bound book.
“There was widespread non-compliance with the Victorian Policy for maintenance pharmacotherapy for opioid dependence. A S8 register was not maintained for pharmacotherapy medicines.
“Dose administration aid filling records were not maintained in accordance with Pharmacy Board of Australia Guidelines.”
The drug refrigerator data logger was not functioning, barcode scanning was not routinely undertaken during dispensing and current editions of several mandatory references were not maintained.
In this case, the licensee was cautioned, and the panel also required the licensee to research Victorian legislation and guidelines relevant to the management of S8 poisons and opioid replacement therapy and develop a written procedure for the management of S8 poisons at the pharmacy and a pharmacotherapy procedure manual detailing the systems in place at the pharmacy.
The VPA expressed disappointment that serious deficiencies in S8 recording and handling continue to feature regularly in its inspections.
The VPA has to “routinely” refer licensees over these issues, it says.
“Licensees should ensure that all pharmacists, including locums, are made aware of procedures for the management of S8 poisons at the pharmacy or pharmacy department,” it warns.
“Written policies and procedures are highly recommended and should address key requirements highlighted in guidance documents issued by MPR particularly Managing Schedule 8 poisons – summary of requirements for pharmacists.”
It urged licensees to ensure the correct handling of S8 poisons in several ways:
- Transactions in S8 poisons must be recorded as soon as practicable.
- A true and accurate balanceof each S8 poison remaining after each transaction must be recorded (this is every pharmacist’s responsibility). Discrepancies must be investigatedwithout delay and any unresolved discrepancies reported to MPR. It is not acceptable to merely correct the recorded balance without identifying the cause of a discrepancy.
- Licensees and Pharmacists in Charge should ensure that procedures are in place to confirm the accuracy of calculated balances regularly.
- Accurate counting of S8 balances is facilitated by appropriate storage. Overcrowded safes orthe storage of a S8 poison in multiple safes can be a barrier to checking and recording the actual balance at the time of dispensing.
- The Authority recommends licensees conduct regular independent audits of S8 transactions (including stock received) on an ongoing basis to ensure accuracy of the register. Lack of adequate supervision or inventory control and non-compliance with regulations have been contributing factors in cases where pharmacists or other staff have misappropriated S8 poisons.
- S8 poisons (including returned and unwanted medicines, RUM) must be stored in a locked facility, fixed to the floor or wall, which provides not less security than a (10 mm thick) mild steel drug cabinet. Attachment requirements for safes are detailed in the MPR document.
- All destructions of S8 poisons must be recorded in the S8 register. Pharmacists should take reasonable steps to ensure any S8 poison returned for disposal is recorded and destroyed in accordance with regulations, including rendered them unidentifiable and unrecoverable to prevent them being retrieved from the RUM bin.
- S8 poisons must not be stored with any other items other than other drugs of dependence.