Opioid replacement therapy – regulations and adherence

*Disclaimer: This article was published in 2019 and reflects the information available at that time.

Pharmacists breaching regulations involving opioid replacement therapy (ORT) are quickly referred to the regulators. A recent blitz from NSW Health against pharmacies that 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.

Inspections may occur without notice at any time. Pharmacy inspectors may check the inventory of ORT products, check the prescriptions for ORT clients, observe the dosing of ORT and take photographs of the premises and any other component of ORT dispensing that is deemed necessary.

From recent reports, the following discrepancies were noted:

• Poor record keeping – recording of ORT supply must be completed daily following the State-specific legislation. This includes hard copies 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 e.g. missing prescriber details or script number.
• Methadone and Biodone present on the same page.
• Large discrepancies in quantities of opioids used in ORT – any discrepancies must be reported to the relevant section of the State Health Department.
• Safes don’t comply with respect to securing to building or dimensions, i.e. 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• Superseded prescriptions are not being marked as cancelled and stored separately.
• Quantities of medications not reconciled at compulsory stock checks, whether compulsory as per State legislation, e.g. March and September in NSW, or per pharmacy protocol.
• Missed dose protocol not being followed and no evidence of communication with the 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.  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.

The following practices are recommended 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, prescription or 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.

Relevant references

OTP Pharmacy Self Audit

ACT:  Opioid maintenance treatment (Opioid Maintenance Treatment in the ACT: Local Policies and Procedures)

NSW: OTP protocol for pharmacists

NT: Code of practice: Schedule 8 substances Volume 1: Issuing prescriptions and supplying schedule 8 substances Part 4B: Dispensing of restricted S8 substances – methadone, buprenorphine, and buprenorphine/naloxone (opioid substitution treatment)

Qld: Qld medication assisted treatment of opioid dependence guidelines

SA: Guidelines for South Australian Pharmacists Dispensing Medication Assisted Treatment for Opioid Dependence (MATOD) 

Tas: Tasmanian Opioid Pharmacotherapy Program Policy and Clinical Practice Standards

Vic: Policy for maintenance pharmacotherapy for opioid dependence

WA: Community Program for Opioid Pharmacotherapy (CPOP)

Call 1300 854 838 if this topic raises any concerns for you, PDL membership includes 24/7 access to speak with a Professional Officer for immediate advice and incident support, Australia wide. Please leave a comment or question for our Professional Officers via the blog below.

Pharmacists’ Support Service (PSS) provides emotional support for pharmacists and are available every day of the year, between 8am and 11pm AEST by calling 1300 244 910.