No room in the safe for pharmacotherapy poisons


Methadone stored in open disposable cups, a “gross failure” to comply with S8 recording and a refit that helped lead to a reprimand were all highlighted at recent panel hearings

In its latest communique, the Authority notes that between January and February 2020 there were 13 panel hearings – seven of which resulted in cautions, and six in reprimands.

It said that out of the 13 hearings, 12 involved failures in timely and accurate recording of S8 poisons transactions, regular reconciliation of S8 poisons stocks and records, and appropriate storage of all S8 poisons

In one case, all the pharmacotherapy poisons were being stored outside of a controlled drug safe.

Instead, they were kept in an unlocked cupboard in the dispensary, reportedly because there was not enough room in the safe to store them.

“In relation to the pharmacy’s pharmacotherapy program, pre-measured doses of methadone were being stored in a refrigerator in the dispensary in open disposable cups, not being sealed and with no means to ensure the accuracy of the dose was maintained until the time of administration of the dose,” the Authority noted.

“The pre-measured cups for methadone were not labelled with the full name of the client and the dose of the methadone.”

This licensee was also reprimanded and a condition imposed on the license requiring submission of quarterly pharmacy self-audits to the Authority.

The Authority noted that, “The Victorian Policy for maintenance pharmacotherapy for opioid dependence recommends that supervised doses are prepared at the time of a patient’s attendance”.

“Some pharmacies have adopted a practice of preparing doses in advance for patients expected to attend during the day,” it said, pointing out that this is not recommended unless several requirements are met.

These include that doses must be placed in clearly labelled containers with secure closures (for example, clearly labelled dispensing bottles), and must be stored securely; the pharmacy must ensure transaction records clearly identify the person responsible for each transaction and ensure transaction records clearly indicate how uncollected doses are disposed of or handled; and aim not to dilute the doses until the time of administration, to enable the pharmacist administering the dose an opportunity to verify the accuracy of the dose.

Another case involved an adjacent Medical Centre, which had a set of keys to the pharmacy.

These keys were collected by locum pharmacists, and returned to the clinic after they had finished their shifts.

However, the keys to the controlled drugs safe were left unsecured in a drawer so that locums could access them during their shifts.

“The Authority reminds all licensees of the need to restrict the control of pharmacy keys to registered pharmacists. This is a requirement of the Pharmacy Regulation Act 2010,” the Authority noted.

“Keys to controlled drug safes should be kept on the person of a pharmacist or be otherwise secured in a manner that provides security equivalent to a controlled drug safe as outlined in the VPA Guidelines.

“These measures help prevent unauthorised access to controlled drugs during or outside of trading hours.”

It observed that this pharmacy also had other problems, including that S8 records did not reflect a true and accurate balance, there was no evidence of any fridge monitoring, and that the pharmacy was missing many of the mandatory references. Some of those it did have were old editions.

This licensee was reprimanded, and required to submit a copy of a written procedure for managing access to keys to the controlled drugs safe and temperature monitoring of the drug refrigerator.

In another case, out of 89 S8 items audited, 34 were found to have inaccurate balances in what the Authority called a “gross failure” to comply with S8 recording requirements.

“Transactions involving Schedule 8 poisons were not recorded as soon as practicable after completing transactions with seventy-two entries outstanding.

“Keys to the Schedule 8 safe were not stored securely overnight.”

In this case, the pharmacy had altered the entire dispensary to accommodate the installation of a robotic dispensing machine – but the licensee had failed to apply to the Authority for the approval of these significant alterations to the premises.

“Licensees are reminded that an application must be made to the Authority and approved prior to undertaking significant alterations to registered premises,” the Authority noted.

“Failure to do so has resulted in panel hearings. Licensees run the risk of having to make changes to premises post-construction where the arrangements do not comply with the VPA guidelines which may have financial consequences for licensees.”

This pharmacy also produced failures relating to barcode scanning, refrigerator temperature monitoring, privacy and display of pseudoephedrine containing products.

The licensee was reprimanded and a condition imposed on the licence; the premises is to be re-inspected at the licensee’s expense, and the Panel also required them to submit a more comprehensive procedure for managing S8s, a revised procedure for managing access to keys to the controlled drugs safe, and a written procedure for temperature monitoring of the drug fridge.

Another panel hearing about a fourth pharmacy heard that boxes and clutter unrelated to dispensing were kept in the dispensary, as was a point of sale data entry station and associated work area, from which clerical activities unrelated to dispensing were being conducted by non-qualified staff.

This pharmacy also had problems with the S8 records not reflecting a true and accurate balance, and with dispensed S8 poisons held for staged supply to clients and those not collected by clients prior to the end of the day’s trade stored in open shelves in the dispensary.

The Authority pointed out that the dispensary should not be accessible to non-qualified staff or used for unrelated activities. The licensee was cautioned.

The fifth case concerned a pharmacy which was undertaking complex compounding – yet did not have a room dedicated to compounding which was separated according to requirements from the rest of the premises.

“By engaging in bulk compounding, the licensee failed to ensure that medicines are only compounded for a particular person for therapeutic application to that person in accordance with the Therapeutic Goods Regulations and Pharmacy Board of Australia (PBA) Guidelines on compounding of medicines,” the Authority said.

It noted that it continues to identify cases where complex compounding is undertaken in inappropriate circumstances.

In this instance – in which the pharmacy also demonstrated other failures to comply with legislation, practice standards and guidelines for good pharmacy practice – the licensee was reprimanded and the pharmacy will be re-inspected at their expense.

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