The Health Protection Service (HPS) has a critical role in promoting the safe and effective use of controlled medicines in the ACT. The HPS actively provides advice and services to doctors, pharmacists and other health professionals to ensure that controlled medicines are prescribed, dispensed and stored safely and in accordance with local legislation.
What are controlled medicines?
Controlled medicines are medicines listed under Schedule 8 of the Commonwealth Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). The ACT adopts the SUSMP under the Medicines, Poisons and Therapeutic Goods Act 2008. Examples of controlled medicines include morphine, oxycodone, dexamphetamine and alprazolam.
The Medicines, Poisons and Therapeutic Goods Regulation 2008 (MPTG Regulation) establishes the regulatory framework for the prescribing and supply of controlled medicines in the ACT.
This regulatory framework that exists for controlled medicines and the capacity to monitor controlled medicines supply via the Drugs and Poisons Information System (DAPIS) database gives the ACT a unique opportunity to be a leader in reducing the harms associated with the abuse, misuse and diversion of these medicines.
Applying for Chief Health Officer Approval
In the ACT all prescribers must have approval from the Chief Health Officer (CHO) (or delegate) to prescribe a controlled medicine for a drug-dependent patient or for ongoing therapy of longer than two months.
An Application to Prescribe Controlled Medicines must be submitted to the Health Protection Service (HPS) for processing. This may take between one – two working days provided that further information is not required in support of the application.
For urgent approval applications, please tick the URGENT box in the top right comer of the application form in so that these can be considered within one working day.
Controlled Medicines Prescribing Standards
To support a flexible approach to the prescription of controlled medicines, the Controlled Medicines Prescribing Standards have been developed.
Under the Controlled Medicines Prescribing Standards Prescribers can seek approval to prescribe a therapeutic class of controlled medicine(s) for a patient through a category approval system or they may seek approval to prescribe by drug, form and strength.
Drug-dependency treatment framework
In the ACT, only endorsed prescribers may commence a patient on methadone or buprenorphine** for treatment of drug dependency. To apply for prescriber endorsement in the ACT, please submit an Application for Endorsement to Treat Drug Dependency to the HPS.
A non-endorsed prescriber may only prescribe methadone or buprenorphine** for treatment of drug dependency for up to five stable patients. These patients must have undergone at least two weeks of continuous therapy under an endorsed prescriber prior to application.
Endorsed and non-endorsed prescribers must apply for either a Category 3 approval or approval by drug form and strength.
CHO approvals will be granted subject to compliance with the ACT Opioid Maintenance Treatment Guidelines.
While not a legislative requirement, it may be of value for prescribers who prescribe methadone or buprenorphine** for treatment of drug-dependency to consider whether a Voluntary Undertaking may be appropriate for some of their patients.
Voluntary undertakings – one doctor and one pharmacy
The Voluntary Undertaking (VU) scheme is a non-legislated, voluntary scheme unique to the ACT. This scheme enables prescribers and pharmacists to support patients whom they suspect may be drug-dependent or are accessing medicines for which there is a market for diversion e.g. benzodiazepines, controlled medicines (including fentanyl patches).
Under the VU scheme (which is valid for six months), a patient and prescriber agree to and sign a VU contract (with an independent person witnessing the signing) so that a patient accesses his/her prescriptions from one doctor and medicines dispensed from one pharmacy.
All VU contract information is maintained by the HPS and regular correspondence regarding VU contract updates is provided to all pharmacies and medical practices in the ACT and Queanbeyan area. Please contact the HPS if you believe that your workplace may not be receiving VU correspondence relating to daily, monthly or quarterly updates.
Seeking CHO approval via Application to Prescribe Controlled Medicines is still required for any controlled medicines to which a VU contract relates to.
*The MPTG Regulation defines a drug dependent person, in relation to a controlled medicine as being a person with a condition:
(a) who, as a result of the administration of the medicine or substance, demonstrates, in relation to the person’s use of the medicine or substance—
(i) impaired control; or
(ii) drug-seeking behaviour that suggests impaired control; and
(b) who, as a result of the cessation of the administration of the medicine or substance, is likely to experience symptoms of mental or physical distress or disorder.
**buprenorphine is taken to include buprenorphine or buprenorphine/naloxone