Recent panel hearings have looked into allegations that licensees had failed to meet their responsibilities to comply with good pharmacy practice at registered premises
Three panel hearings were held in May by the Victorian Pharmacy Authority into allegations that pharmacy licensees had failed to meet their responsibilities to comply with the Pharmacy Regulation Act 2010.
In the first case, the directors of a newly established pharmacy 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; and incomplete signs identifying the proprietor, pharmacist-in-charge and duty pharmacist. There were also deficiencies in the labelling and handling of dose administration containers.
The Panel was “extremely disappointed with the level of non-compliance” 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”.
The second case involved multiple deficiencies in the recording and storage of Schedule 8 poisons (including pharmacotherapy drugs); inadequate staffing; incomplete works of reference; and unsatisfactory temperature control.
And the third case involved what the Panel found to be failure to maintain appropriate security in that the intrusion detector alarm was not functional; unsatisfactory temperature control; privacy deficiencies; poor record keeping of medicines used in dose administration containers; and inadequacy of mandatory signs.
The Panel also found that the pharmacy had poor recording of transactions of Schedule 8 poisons (including methadone and Suboxone), and unauthorised supply of a Schedule 8 poison.
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 all three cases, the licensees were reprimanded, and a condition inserted into the licences that quarterly self-assessments be conducted.
The completed audit form must be returned to the Authority, accompanied by a statutory declaration. The premises are to be reinspected at the licensees’ cost.
As well as the general determination, the licensee in the third case had to submit additional information to support that the deficiencies had been rectified.