Pharmacy licensees warned that cases of suspected serious breaches of drugs and poisons legislation will be referred to the Department of Health and could result in a prosecution
Between August and October 2019, there were 15 panel hearings into allegations that licensees had failed to meet their responsibilities to comply with legislation at registered premises, reports the Victorian Pharmacy Authority (VPA).
Fourteen of the hearings involved at least one of the following issues:
- Failing to ensure records of Schedule 8 poisons showed the true and accurate balance;
- Failing to ensure records of methadone or buprenorphine (for the purposes of opioid replacement) were made at least daily;
- Failing to store S8 poisons in accordance with legislation;
- Failing to investigate discrepancies in S8 poisons and notifying the department of discrepancies that could not be resolved.
Eight hearings resulted in licensees being cautioned and six hearings resulted in reprimands.
Two cases involved serious failures in relation to the storage of S8 poisons.
In one of these, significant quantities of returned and unwanted S8 poisons were kept in a drawer in the dispensary.
This is not the first time the pharmacy had been warned—the Department of Health and Human Services, Medicines and Poisons Regulation (MPR) had previously issued an infringement notice to the pharmacy in relation to the storage of S8 poisons in a drawer, following an inspection in 2018.
Further deficiencies relating to S8 poisons in this pharmacy included poor record management and the use of a S8 safe that was not fixed to the floor or wall.
Licensees are reminded that such breaches present a serious risk to public safety and could result in a prosecution.
According to the Drugs, Poisons and Controlled Substances Regulations 2017 (Victoria), all S8 poisons are required to be stored in a lockable storage facility of a certain construction, that is securely attached to a wall or floor.
Pharmacy licensees must take all reasonable steps to ensure that the storage facility remains locked and secured at all times, except when it is necessary to open it to carry out an essential operation in connection with the poisons stored in it.
Following the VPA inspection, the MPR invited the licensees to show cause why they should not be prosecuted for “repeated contraventions”.
“The Authority continues to refer cases of suspected serious breaches of drugs and poisons legislation to MPR for consideration of further action,” says VPA Chair David McConville.
“Licensees are reminded that such breaches present a serious risk to public safety and could result in a prosecution.”
In a second case, large quantities of S8 poisons held for the purpose of filling dose administration aids were stored in a cupboard.
Additionally the dose administration aid filling area was not maintained in a hygienic manner.
The licensee was reprimanded and must submit to a pharmacy self-audit.