Controlled Medicines

Pharmaceutical Services has a critical role in promoting the safe and effective use of controlled medicines in the ACT. Pharmaceutical Services 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 prescription medicines that are associated with an increased risk of misuse, abuse, dependency or diversion. These medicines are subject to greater regulatory control to minimise their potential harms to individuals and public health.

Controlled medicines are listed under Schedule 8 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Common types of controlled medicines include potent opioids such as morphine, psychostimulants such as dexamphetamine and some benzodiazepines such as alprazolam.  The ACT adopts the SUSMP and regulates the supply of controlled medicines under the Medicines, Poisons and Therapeutic Goods Act 2008.

Regulatory Requirements for controlled medicines

Prescribing controlled medicines

In order to minimise the public health risks associated with controlled medicines, prescribers need to hold a valid approval to prescribe a controlled medicine for each patient in the ACT.

Prescribers may apply to the Chief Health Officer for approval to prescribe a controlled medicine. 

Applications for approval to prescribe a controlled medicine are generally processed within 1-2 business days. Approved applications are assigned an identifying approval number which must be annotated on prescriptions. Pharmacists cannot dispense controlled medicines in the ACT without citing a prescription’s relevant approval details.

Applications for approval to prescribe a controlled medicine should be forwarded to Pharmaceutical Services using the below form:

A prescriber may also prescribe a controlled medicine under a standing controlled medicines approval for either hospital in-patients or for short-term therapy.

A short-term standing approval is in place to facilitate a patient’s short-term treatment with a controlled medicine. A short-term standing approval can only be used to initially prescribe a controlled medicine for a maximum of two months for patients that are not considered drug-dependent.

The prescribing of controlled medicines for on-going therapy, or for patients that have been prescribed a controlled medicine in the previous two months or considered drug-dependent, requires approval from the Chief Health Officer. 

Prescriptions for controlled medicines issued under a short-term standing approval must also be annotated with relevant approval details.

Further information for prescribers on the prescribing of controlled medicines in the ACT may be found in the information sheets below.

Prescribing controlled medicines for the treatment of drug-dependency

Prescribing controlled medicines for patients that are commencing or continuing opioid maintenance therapy is a complex matter that warrants careful consideration.

Due to the complexities of prescribing controlled medicines for the treatment of drug-dependency, prescribers cannot prescribe controlled medicines for drug-dependent persons, or for the treatment of drug-dependency under a short-term standing approval. 

Prescribers may apply to the Chief Health Officer for approval to prescribe a controlled medicine for use in an opioid dependency treatment program.

Applications for approval to prescribe a controlled medicine to commence treatment of drug-dependency will only be approved for prescribers that hold an endorsement to treat drug-dependency.

A non-endorsed prescriber will only be approved to prescribe a controlled medicine for the treatment of drug-dependency for up to five stable patients if the patient has already completed two weeks of continuous therapy under an endorsed prescriber.

The treatment of opioid dependency should occur in accordance with the Opioid Maintenance Treatment Guidelines

Applications for approval to prescribe a controlled medicine for the treatment of drug-dependency should be forwarded to Pharmaceutical Services using the below form:

A prescriber may apply to the Chief Health Officer for endorsement to treat drug-dependency by submitting the below form to Pharmaceutical Services:

Dispensing controlled medicines

A prescription for a controlled medicine must include relevant approval particulars before it can be legally dispensed by a pharmacist in the ACT (other than for hospital inpatients).  Pharmacists should not dispense a controlled medicine without citing evidence of the prescription’s authority e.g. a CHO approval number or standing approval annotation. 

Pharmacies are required to keep a controlled medicines register which must record the type and amount of controlled medicines stocked and dispensed at their pharmacy. Any discrepancy in a pharmacy’s controlled medicines register due to product loss or theft should be immediately reported to Pharmaceutical Services. Any instances of suspected theft should also be reported to the police.

Information on controlled medicines dispensed by pharmacies must be reported each month to the Chief Health Officer. Pharmacy dispensing reports can be submitted electronically. This information is used by the Chief Health Officer to monitor and regulate the public health risks of controlled medicines supply in the ACT.

Further information on the dispensing and storing of controlled medicines in the ACT may be found in the information sheet below.

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