Prescribing methadone and buprenorphine to treat opioid dependence.
Prescribing methadone and buprenorphine under the
PBS section 100 Opioid Dependence Treatment Program has additional requirements to other
Schedule 8 Drugs of Addiction (S8).
- Prescribers must obtain an
Authority to prescribe methadone or buprenorphine from Pharmaceutical Regulatory Unit (PRU) prior to writing the first prescription for a patient.
Prescribers must apply for an NSW authority from PRU before prescribing any other S8 drug of addiction to a patient already on the Opioid Treatment Program (OTP) (for example alprazolam, oxycodone). This is independent of a Medicare/PBS authority.
- Prescribers are required to notify PRU of locum arrangements if they go on leave and if there has been a change in dosing point for a patient.
Ensure the prescription is valid for dispensing by community pharmacist
Prescriptions for Schedule 8 drugs of addiction must be compliant with
clause 80 of the Poisons and Therapeutic Goods Regulation 2008
and methadone and buprenorphine prescribed for the treatment of opioid addiction are not an exception:
- Microsoft Word documents and templates are not valid prescriptions – only use approved prescribing software.
- Ensure adequate dosing instructions including total daily dose and any variations applicable.
- "continue with usual dose" is not an adequate instruction.
- Clearly specify directions for dilution with approved diluent, if applicable.
- Giving directions to use a non-approved diluent (e.g. apple juice).
- Provide clear instructions for the provision of any unsupervised doses (confirm the days the pharmacy is open to ensure dosing availability).
- Giving unclear unsupervised dose frequency instruction (e.g.
- Include a date range for dosing if the total quantity prescribed is difficult to determine.
- Allowing prescriptions to expire without planned reviews or during extended leave without nominating a locum prescriber.
Forward the prescription directly to the pharmacy
Never give a patient a physical (original or copy) OTP prescription. Instead, forward the prescription directly to the dosing pharmacy to avoid loss or misplacement of prescription, presentation by the patient at another pharmacy, or alteration of the prescription by the patient.
Prescriptions ordered by phone, email or fax must be sent immediately to the pharmacy. Pharmacists are obliged to report non-receipt of prescriptions within seven (7) days to PRU.
Prescribers must confirm in writing any verbal orders to change the number of takeaway days or the prescribed dose of medicine. Any changes to the takeaway schedule or changes to dosage must be confirmed with a signed and dated order by the prescriber on the prescriber's official letterhead or new prescription sent to the pharmacy.
Examples of valid prescriptions
Prescribers must keep medical records of the prescription and directions for a minimum of seven (7) years. Pharmacists are must keep drug register records, prescription records, and dispensary records at the pharmacy premises for two (2) years.
Communicate and collaborate with pharmacists
Pharmacists have a duty to only dispense medicines from a valid prescription and are advised to contact prescribers when there are concerns about prescription validity or where there are concerns about patient safety.
Patients depend on collaborative clinical relationships between prescribers and pharmacists to ensure that clinical issues that arise with the patient can be discussed and resolved. Prescribers should proactively contact the pharmacist to facilitate more complete clinical review.
It is important that prescribers are responsive to pharmacist enquiries about treatment of their OTP patients. Examples include general patient health, missed doses, presenting for dosing intoxicated, other substance use, and sedating medicines or S8s prescribed by other doctors treating the patient.
Depot buprenorphine must never be handled by patients
Depot buprenorphine prefilled syringes must never be supplied or given to a patient. Arrangements must be made with the pharmacy to deliver the depot buprenorphine on prescription for each individual patient to the medical practice. Medical and nurse practitioners can also arrange wholesaler direct delivery. Serious harms can result from patients attempting to self-administer depot buprenorphine.
Information about prescribing depot buprenorphine.
Opioid Treatment Program enquiries
Applications, transfers or exits for the NSW Opioid Treatment Program:
Telephone: (02) 9424 5921 or 9391 9944 (Select option 3) Fax: (02) 9424 5885