Authority looks into allegations of ‘serious deficiencies’ including use of expired materials, and warns of recurring non-compliance related to compounding and S8s
In June and July this year, the Victorian Pharmacy Authority held 10 panel hearings into allegations that licensees had failed to comply with legislation and regulations for good pharmacy practice at registered premises.
One licensee was reprimanded over “serious deficiencies” in relation to complex compounding.
These included the use of expired starting materials, failure to maintain accurate compounding documentation including compounding worksheets, and failure to ensure staff were wearing appropriate protective clothing.
The licensee also failed to maintain records of transactions for Schedule 8 poisons, including starting materials for compounded medicines, or to routinely undertake barcode scanning during dispensing.
Another licensee was reprimanded for failing to implement a procedure for temperature monitoring of the drug refrigerator or maintain current editions of mandatory references.
They also failed to routinely undertake barcode scanning during dispensing or maintain accurate records for some S8 poisons.
There is recurring non-compliance in relation to complex compounding and S8 poisons in pharmacies across the state, said the Authority.
It strongly encouraged all pharmacy licensees to develop and implement policies and procedures to ensure ongoing compliance in key areas including:
- Management of Schedule 8 poisons (including storage, records and disposal)
- Maintenance of the cold chain, including the use of temperature data loggers
- Dose administration aid packing and records
- Maintenance of current editions of mandatory reference texts
- Compounding of medicines, including required risk assessments
“Panel hearings and meetings with licensees continue to highlight that many pharmacies do not have written policies and procedures addressing key areas, or that staff – including locums – are not aware of them,” it said.
“Licensees and pharmacists in charge should not rely on routine inspections by Authority officers to identify areas of non-compliance.”
Two further licensees were also cautioned in the past few months.
In the first case complex compounding, including compounding involving the handling of hazardous substances, was undertaken at the pharmacy premises despite there being no dedicated compounding laboratory, and no powder containment cabinet for operator and environment protection.
In the second case, the licensee had failed to store S8 poisons in a drug safe in accordance with the legislation, with methadone and buprenorphine being stored in a cupboard.
Barcode scanning was not routinely undertaken during dispensing and accurate records were not maintained for some Schedule 8 poisons.
Altogether the Authority found there was “widespread non-compliance” with relevant policies.