Pharmacists have been warned of the consequences of failing to correctly manage, record and dispense opioid replacement therapy medicines
PDL warned its NSW members in a practice alert that action is swift when pharmacies are found not to have complied with regulations around these medicines.
“Pharmacists breaching regulations involving opioid replacement therapy are quickly referred to the regulators,” says PDL.
“A recent blitz from NSW Health against pharmacies who provide opioid-replacement services is resulting in members of PDL seeking support in handling regulator inquiries.
“Penalties such as restrictions on practice for pharmacy owners and employed pharmacists may be involved.
“These incidents highlight the importance of adhering to current State-based legislation when dealing with all S8 medications, including ORT products such as methadone syrup, Subutex and Suboxone.”
PDL reminds pharmacists that inspections can occur at any time without notice – and will include a check of the inventory of ORT products, as well as the scripts for ORT clients.
These inspections also observe the dosing of ORT and include having photographs taken of the premises and any other component of ORT dispensing that is deemed necessary.
PDL lists a number of recent discrepancies noticed at such inspections. These include:
- Poor record-keeping. “Both subsidiary registers and daily registers must be filled out each day,” says PDL. “This includes hard copy and electronic registers.”
- DD register not available on the premises for inspection.
- DD register filled out by non-pharmacist staff members.
- Entries in the DD register crossed out, obliterated, missing or incomplete, such as missing prescriber details or script number.
- Methadone and Biodone present on the same page.
- Large discrepancies in quantities of opioids used in ORT – PDL reminds pharmacists that any discrepancies must be reported to the Pharmacy Regulation Unit.
- Safes which do not comply with respect to securing to building or dimensions, such as thickness.
- Non-compliant storage of S8 medications – for example in a locked cupboard or unsecured in the dispensary or stockroom.
- Dispensing from invalid prescriptions that are not written correctly.
- Patient records, including a photograph and current contact details, missing.
- Non-pharmacy staff having “unfettered access” to the dispensary or S8s.
- Evidence of methadone takeaway bottles being reused.
- Superseded prescriptions not being marked as cancelled and stored separately.
- Quantities of medications not reconciled at compulsory stock checks, required every March and September.
- Missed dose protocol not being followed and no evidence of communication with prescriber.
- Undocumented maintenance and calibration checks of the methadone measuring apparatus.
“Performing regular self-audits and training will ensure that, should an inspection occur, the pharmacy can display compliance in the area of ORT,” PDL warns.
“There are several State-based reference documents available. Members are encouraged to have these readily available in the pharmacy either in hard copy or in an electronic form.
PDL also recommended a number of strategies to reduce incidents and non-compliance with ORT:
- Access and familiarisation with the current ORT State-based legislation and guidelines.
- Accurate and frequent (daily) entries to the subsidiary register and DD register, which is to be kept on the premises at all times.
- Frequent stock counts and reconciliation of all ORT products.
- Correct and valid documentation of prescriptions.
- Clear and documented communication with both clients and prescribers.
- Consistency by all pharmacists involved in ORT services and use of self-audit tools to maintain compliance.
The alert comes shortly after the publication of an article by 10 Daily which criticised pharmacists for their handling of ORT—including not giving a patient a second dose when she spilled the first—and the strict regulations which apply to it.