The VPA has given details of several panel hearings – three of which related to significant alterations to the pharmacy premises
Eight panel hearings into alleged failures to meet responsibilities to comply with the Pharmacy Regulation Act and/or good pharmacy practice were held in March and April 2020, says the Victorian Pharmacy Authority.
In one case, there was deemed to have been a failure of good pharmacy practice at the registered premises for several reasons.
“S8 poisons records were not being made as soon as practicable after completing a transaction,” the VPA noted.
“There were 20 transactions for S8 poisons supplied and seven invoices for S8 poisons received that were not recorded in the drug register.
“S8 poisons records did not show the true and accurate balance of each S8 poisons remaining after each transaction.
“There were 22 discrepancies between the calculated drug register balance and the actual S8 poison balance having accounted for.
“Drug safes must be dedicated to the storage of drugs of dependence. In this instance, cash was found to be stored in the drug safe.”
This premises was found to have “numerous” other issues of concern, relating to the mandatory reference library, drug refrigerator temperature monitoring, pharmacotherapy and vaccination.
In the vaccination area, the anaphylaxis kit was insufficient and not easily accessible; the vaccination emergency response protocol was not displayed, and there was no available first aid couch.
Copies of the pharmacist immuniser’s certificate of training, first aid and CPR certificates were not displayed.
This licensee was reprimanded with conditions imposed on the licence requiring quarterly audits of the pharmacy and a pharmacotherapy self-assessment.
The licensee was also required to submit written procedures on management of S8 poisons, temperature monitoring of the drug refrigerator and pharmacotherapy, including on segregation of non-current pharmacotherapy prescriptions from current pharmacotherapy prescriptions at the pharmacy.
The VPA points out that “delaying the task of making a S8 poison 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 the transaction occurred”.
In another case, the licensee had significantly altered the premises without VPA approval.
These unapproved alterations included the addition of a compounding room located outside the dispensary, the relocation of the staff room and changes to the area dedicated to the filling of dose administration aids.
There were several other failures to comply with legislation, practice standards and guidelines for good pharmacy practice.
This licensee was cautioned, and the Panel also requested written procedures for the management of S8 poisons, drug refrigerator temperature monitoring and complex compounding at the pharmacy.
The VPA reminded licensees that they must have the Authority’s prior approval before making significant alterations to a pharmacy or pharmacy department.
Significant alterations include (but are not limited to):
- alterations to the perimeter or perimeter security of the premises;
- alterations affecting public access to the premises;
- alterations to the dispensary including changes to the perimeter and access to the dispensary;
- addition of a compounding room or DAA filling room separate to the dispensary; and
- alterations to counselling areas.
In a third case, several failures of good pharmacy practice included the packing of hazardous medicines into DAAs not being undertaken in a suitable environment using suitable equipment, systems and techniques to minimise direct exposure of the operator to these medicines.
There was also a problem with non-adherence to the cleaning and maintenance protocol for the automated dose packing system, and no records of the pharmacist who checked the DAAs were made and kept.
In this case, the premises had also undergone a significant alteration without the VPA’s approval.
The licensee was reprimanded and a reinspection of the pharmacy ordered.
A fourth licensee was reprimanded after they distributed the profit of the pharmacy business to non-pharmacist family members via a trust associated with the pharmacy business.
“Where an applicant or licensee decides to establish a trust in association with a pharmacy business, advice should be sought from their legal and financial advisors to ensure the trust complies with the Act,” says the VPA, referring pharmacists to its commercial arrangement guidance document on trusts.