‘Serious deficiencies’—four panel hearings


Expired compounding starting materials, storing S8s outside a drug safe and using open baskets which could pose a risk to privacy were all subjects raised at recent Panel Hearings

The Victorian Pharmacy Authority has given details of four recent Panel Hearings – several of 15 it held between May and July 2019 into allegations that licensees had failed to meet their responsibilities.

In the first case, the licensee failed to maintain true and accurate balances of Schedule 8 poisons in their possession, the VPA says – and some S8s were not stored in a drug safe.

“The identity of dispensed medicines was not kept private in that open baskets were used for transfer between the dispensary and cash and wrap counter, the matter having been raised in a previous inspection,” the VPA notes.

“Barcode scanning was not routinely undertaken during dispensing in accordance with Pharmacy Board of Australia Guidelines.

“The licensee was cautioned and required to develop and submit a procedure to assure the privacy of dispensed medicines in the pharmacy on an ongoing basis.”

The VPA reminded pharmacists that the Pharmacy Regulation Act 2010 outlines the need for privacy procedures to be in place.

The Act requires that, “Adequate arrangements are in place to ensure that the identity of a medicine being supplied or dispensed to a client of the pharmacy or pharmacy department cannot be known by another person present in the pharmacy or pharmacy department who is not a person carrying on the pharmacy business or pharmacy department or a member of the staff of the business or department”.

The VPA reminded pharmacists about a recent case, which received coverage in the mainstream media, about a patient being robbed at knifepoint after leaving a pharmacy in Western Australia.

In this case, the patient had just had a script for alprazolam tablets filled – which the attacker demanded, along with the patient’s wallet.

“It is not clear whether or not the dispensed medicines were identified by the attacker in the pharmacy.

“However, when informing staff and consumers about the legislative requirement to maintain the privacy of dispensed medicines in the pharmacy, licensees are also encouraged to highlight the potential public safety risks that could result from consumers’ medicines being identifiable after dispensing,” the VPA observed.

Compounding deficiencies

The second hearing involved a case where complex compounding, including compounding involving the handling of hazardous substances, was undertaken at the pharmacy premises without a dedicated compounding laboratory, contrary to the requirements of VPA Guidelines.

In this case, expiry dates for compounded medicines were not assigned in accordance with good pharmacy practice in that creams and ointments were labelled to be discarded a number of days after opening.

“The premises were not maintained in a clean and hygienic manner with respect to the compounding activities,” the VPA says.

“There was inadequate barcode scanning, no procedure for temperature monitoring of the drug refrigerator using a temperature data logger and deficiencies in required references.

“Some S8 poisons were not stored in a drug safe. These included a raw material for compounding, the matter having also been noted at a previous inspection.

“The licensee was reprimanded and a condition imposed on the premises registration that complex compounding is not to be undertaken at the registered premises.”

The third case also related to complex compounding, and featured “serious deficiencies,” the VPA says.

These deficiencies included the use of some starting materials that had expired, as well as failure to maintain accurate compounding documentation including compounding worksheets.

This pharmacy also failed to ensure that staff work appropriate protective clothing; failed to maintain records of transactions in S8s, including starting materials for compounded medicines, and failed to routinely undertake barcode scanning during dispensing.

The VPA said that this licensee was reprimanded and a re-inspection of the registered premises to be carried out at the licensee’s cost.

As for the fourth case highlighted by VPA, the licensee in question had certified that matters had been addressed following a previous inspection.

However, the licensee failed to implement a procedure for temperature monitoring of the drug refrigerator, to maintain current editions of mandatory references, and to routinely undertake barcode scanning during dispensing.

“Accurate records were not maintained for some Schedule 8 poisons and daily transaction records were not being made for pharmacotherapy medicines as required by the legislation,” said the VPA.

“The licensee was reprimanded. A re-inspection of the registered premises will be carried out at the licensee’s cost.

“The Panel also requested copies of procedures for drug refrigerator temperature monitoring, pharmacotherapy storage and recording, and pharmacist-administered vaccinations at the pharmacy.”

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