S8s for compounding stored on open shelf


Two recent panel hearings have demonstrated the importance of correct management of S8 poisons, as well as who accesses the premises and when

In its latest circular, the Victorian Pharmacy Authority outlines two cases where it was alleged that licensees had failed to meet their responsibilities to comply with the Pharmacy Regulation Act and/or good pharmacy practice at registered premises.

The hearings took place between May and July 2020.

In one case, it was found that there was a failure of good pharmacy practice at a store around how S8s were managed there.

S8 poisons used to compound medicines were found stored on an open shelf in the compounding area, rather than in a lockable drug safe.

Meanwhile S8s for opioid replacement therapy were stored in a drug safe – but tis safe did not meet legislated minimum requirements.

At this pharmacy, S8 poisons records were not being made as soon as practicable after a transaction was completed – and the records did not show the true and accurate balance of each S8 poison remaining after each transaction.

There were 18 discrepancies between the calculated drug register balance and the actual S8 poison balance.

The S8 poisons record for ORT was not recorded in the drug register at least daily.

The licensee was cautioned, bearing in mind that they had already implemented remedial actions.

“Pharmacists are reminded that they must verify that the drug register shows the true and accurate balance of Schedule 8 poisons remaining after each transaction – a legal obligation that is often hindered by the pharmacist’s decision to delay the task of making a record in the drug register,” the VPA noted.

It highlighted that the Medicines and Poisons Branch (MPR) guidance document Managing Schedule 8 poisons – requirements for pharmacists says that delaying the task of making a record in the drug register until it is more convenient is “unlikely to satisfy the requirement to record transactions as soon as practicable unless the record is made on the same day as the transaction occurred”.

“The practice of delaying this task for days, weeks or months is unacceptable and is being increasingly dealt with by the Authority, in some cases, prosecution by MPR,” warned the VPA.

 

Controlling the keys

Meanwhile at another pharmacy, it was found that a person who was not a pharmacist had access the premises with a colleague before it opened for business – without a registered pharmacist present.

“The licensee maintained that this was the first occurrence because the regular morning pharmacist was unexpectedly unavailable to work,” the VPA noted.

It was determined that the licensee failed to restrict the control of keys to the pharmacy premises to registered pharmacists in accordance with the Act; and allowed a person to have access to the pharmacy when it was not open for business and when a registered pharmacist was not present in contravention of the Act.

“The licensee also failed to comply with the Victorian Pharmacy Authority Guidelines, regarding the storage and/or possession of keys to the controlled drug safe,” the VPA said.

“There was also inadequate dose administration aid records, no procedure for temperature monitoring of the drug refrigerator using a temperature data logger and an inadequate reference library.

“The licensee was reprimanded, and a condition was imposed on the licence requiring the licensee to conduct a review of relevant legislation and guidelines and prepare for submission to the Authority a report detailing their responsibilities as a proprietor and ongoing commitment to meeting those responsibilities.

“Access to a closed pharmacy or pharmacy department by a person in the absence of a registered pharmacist is an offence under the Act for which licensees and pharmacists in charge may be liable.”

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