Controlled Medicines

Controlled Medicines

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 Poisons Standard. The ACT adopts the Poisons Standard under the Medicines, Poisons and Therapeutic Goods Act 2008. Examples of controlled medicines include morphine, oxycodone, dexamfetamine 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.

The 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 for approval to prescribe a controlled medicine must be submitted to the Health Protection Service (HPS) for processing. This may take between one to 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 corner of the application form 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 ACT 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 (Category Approval) or they may seek approval to prescribe by drug, form and strength (Approval by Drug).

Links

Opioid Maintenance Treatment

Prescribers

In the ACT, a prescriber may prescribe a controlled medicine (methadone or buprenorphine**) for treatment of drug dependency. A prescriber needs to obtain an approval from the Chief Health Officer prior to prescribing these medicines using an Application for Approval to Prescribe a Controlled Medicine.

Category 3 of the ACT Controlled Medicines Prescribing Standards describes conditions and criteria to prescribe methadone or buprenorphine** under an approval. In addition, prescribers are required to prescribe methadone or buprenorphine** in accordance with the National Guidelines for Medication Assisted Treatment of Opioid Dependence (2014). Prescribers should also endeavour to comply with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.

Only endorsed prescribers may commence a patient on opioid maintenance treatment and/or prescribe for more than five stable patients concurrently. Non endorsed prescribers may only be approved to prescribe methadone or buprenorphine** where they are prescribing continuing treatment for up to five drug dependent patients at a time.

Prescribers seeking to become an endorsed prescriber to treat drug dependency in the ACT must undertake training provided by ACT Health. Training requirements are outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval 2018 (No 1). Prescribers may apply to the Health Protection Service to become an endorsed prescriber using an Application for Endorsement to Treat Drug Dependency.

Apply Online

Pharmacies

In the ACT, community pharmacies need to be licensed to dispense methadone or buprenorphine** for treatment of drug dependency. Pharmacists may apply to the Health Protection Service, to obtain an Opioid Dependency Treatment Centre Licence using an Application for Opioid Dependency Treatment Centre Licence (Pharmacist).

Pharmacists are also required to dispense methadone or buprenorphine** in accordance with the National Guidelines for Medication Assisted Treatment of Opioid Dependence (2014). Pharmacists should also endeavour to comply with the Opioid Maintenance Treatment in the ACT: Local Policies and Procedures wherever possible.

A pharmacist that holds an Opioid Dependency Treatment Centre Licence at a community pharmacy must ensure that all pharmacists dispensing treatment have successfully completed a training program to allow the safe administration and/or dispensing of opioid maintenance treatment. Training requirements are outlined in the Medicines, Poisons and Therapeutic Goods (Guidelines for treatment of opioid dependency) Approval 2018 (No 1).

**buprenorphine is taken to include buprenorphine or buprenorphine/naloxone

Local contacts and program related information can be accessed from the Alcohol and Drug Services webpage.

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 for approval to prescribe a controlled medicine is still required for any controlled medicines to which a VU contract relates.

MPTG Regulation

*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.