A case study explores how one pharmacy racked up so many issues it might seem “extreme, or even unbelievable”, according to the NSW Pharmacy Council
While the ability of community pharmacy to offer the Opioid Treatment Program (OTP) is very valuable, this comes with the responsibility of maintaining strict compliance with all legal requirements, says the Pharmacy Council of NSW in a recent missive.
“The consequences of failing to do so can be severe,” it says.
According to NSW protocols, legislative requirements for receipt, storage, and supply of methadone and buprenorphine under the OTP are, at a minimum, the same as for any other Schedule 8 medication. However, specific monitoring and supervisory requirements of the OTP imposes additional obligations.
The Council shared one case study, in which the Pharmaceutical Regulatory Unit (PRU) – which inspects pharmacies for compliance with the OTP – found several infractions within a pharmacy. These included:
- “appalling and indecipherable” OTP records;
- large discrepancies in their Schedule 8 records which had not been reported to the PRU;
- not being able to locate drug registers at the time of the inspection;
- an electronic drug register which was not up to date;
- dispensed opioids and benzodiazepines for OTP patients on prescriptions from multiple doctors;
- supplied more take-away doses of methadone than were prescribed;
- dispensed Schedule 8 medicines from illegal and non-compliant prescriptions.
“This scenario may seem extreme, or even unbelievable, however, it is by no means rare,” says the Council, adding that when it receives a report like this, “it must and will take action.”
In the above scenario, the pharmacist owner was required to appear before the Council. As a result, they had conditions placed on their registration, including that they were unable to work as a pharmacist in charge and not permitted to handle any Schedule 8 drugs.
“Council firstly seeks to understand WHY the scenario had progressed to the state found by the PRU. In some cases, pharmacists are found to be ignorant of the law, but in other cases, they have chosen to disregard it or interpret the law as a guideline only, and have justified their reasons for not complying,” it says.
Any short-cuts and sloppy practices can easily become a habit and infect the culture of the pharmacy.
The Council says it has heard justifications such as:
- “I will write that up later’ or “we write up our drug register on Fridays for the whole week”;
- “I am too busy to do a stock check”;
- “I won’t report to PRU now. I will find the error”;
- “Another person is responsible for reconciling the Schedule 8 drugs”;
- “I trust the pharmacist in charge to do that”;
- “I’ve known this patient for many years. It is OK to dispense an extra takeaway, or give an extra dose until I receive the new script, because I trust them”;
- “The doctor hasn’t written the script properly, but I know what he means”;
- “The doctor may be angry if I ask for the script to be rewritten”.
The Pharmacy Council of NSW says: “Unfortunately, even when the pharmacist does not deliberately set out to ignore the protocols, guidelines and legislation, any short-cuts and sloppy practices can easily become a habit and infect the culture of the pharmacy.
“Council then seeks to ensure that sloppy practices are stopped and the pharmacy returns to full compliance with the law.”
In this case study, the Council eventually removed the conditions after the pharmacist was able to demonstrate that they had undertaken appropriate education in revising the legal requirements around S8 drugs and the OTP in particular, and made changes to practices in the pharmacy.
The Council urges any NSW pharmacy providing an OTP service, including all pharmacist staff including locums, to follow the NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol at all times.
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