What not to do: Three pharmacy owners have been reprimanded and two cautioned in recent panel hearings into their pharmacy practice
In the first quarter of 2018 alone, the Victorian Pharmacy Authority held five panel hearings into allegations that licensees had failed to meet their responsibilities to comply with the Pharmacy Regulation Act 2010 and/or good pharmacy practice at registered premises.
The first case involved the directors of a newly-established pharmacy, who appeared before a Panel to answer charges alleging:
- failures of physical security at the premises;
- lack of confidentiality in disposing of records and containers;
- inadequate temperature monitoring;
- incomplete equipping including works of reference;
- incomplete signs identifying the proprietor, pharmacist-in-charge and duty pharmacist; and
- deficiencies in the labelling and handling of dose administration containers.
The Panel was “extremely disappointed with the level of non-compliance” at this pharmacy, and “dismayed that in order to gain premises registration [the licensee] had submitted a notification of completion declaring that the premises had been completed according to the approved plans…when they had not”.
In the second case, authorities found multiple deficiencies in the recording and storage of Schedule 8 poisons (including pharmacotherapy drugs).
They also noted inadequate staffing; incomplete works of reference; and unsatisfactory temperature control.
A proprietor involved in a third case was found to have failed to maintain appropriate security in that the intrusion detector alarm was not functional, and they had unsatisfactory temperature control.
The pharmacy had poor recording of transactions of Schedule 8 poisons (including methadone and Suboxone), unauthorised supply of a Schedule 8 poison and privacy deficiencies.
Poor record keeping of medicines used in dose administration containers and inadequacy of mandatory signs formed additional charges in this case.
A previous inspection had drawn a number of these matters to the pharmacist’s attention and despite having certified that they had been rectified, the follow-up inspection had shown that they had not.
In a fourth case, the licensee had failed to ensure that the records of all transactions in Schedule 8 poisons show the true and accurate balance of each Schedule 8 poison remaining after each transaction.
Additionally authorities found they had failed to ensure that the records of all transactions in respect of methadone or buprenorphine were made at least daily.
And in a fifth case, the owner failed to ensure that medicines are not re-used after dispensing and after they have left the pharmacy. In this instance, patients’ dispensed medicines were being used to fill dose administration aids for other patients.
Calculated and actual balances of opioid replacement therapies were not reconciled regularly by this fifth pharmacist owner.
The mandatory sedation warning label was not routinely applied to dose administration aids where indicated, and there were not adequate arrangements to ensure that client information could not be obtained from discarded documents.
In the first three cases the licensees were reprimanded, and a condition inserted into the licences that quarterly self-assessments be conducted, and the completed audit form be returned to the Authority, accompanied by a statutory declaration. The premises are to be reinspected at the licensees’ cost.
Meanwhile in a fourth and fifth case, the licensees were cautioned.