Schedule 4 Monitored Medicines

Storage and recording requirements

There is no specific requirement under the Medicines and Poisons legislation for storage or record the movement of S4 monitored medicines. 

Prescribing S4 reportable medicines

All prescribing must conform to the criteria and conditions outlined in Part 1 and the Risk management approach to treatment with S4 reportable medicines outlined in Part 8 of the Code.

Authorisation from the CEO is not required to prescribe S4 reportable medicines.

Risk management approach to treatment with S4 reportable medicines

Prescribers are required to confirm in ScriptCheckWA that they are the only prescriber of these medicines prior to prescribing and the patient has no current prescriptions.

To mitigate potential harms associated with these medicines, a documented plan to mitigate potential harms must be included in the medical records for patients in the following cases:

• patient is recorded as a Drug Dependent person or Oversupplied person
• patient is currently on OST through CPOP
• patient is taking concurrent opioids with benzodiazepine medicines
• patient is being prescribed monitored medicines by multiple prescribers
• the condition being treated is not a ARTG indication for the product
• the dose taken by the patient is above the recommended dose in the product information for the condition being treated.

Mitigation strategies may include:

• reviewing history in ScriptCheckWA prior to prescribing or dispensing
• staged supply or limited quantities
• treatment contract
• no early prescriptions
• ensuring the dose is clear including a maximum daily dose on prn prescriptions
• limiting supply from a single pharmacy
• referring to drug and alcohol services for management of dependence.

S4 restricted medicines

S4 restricted medicines included in the Western Australian Department of Health Medicines Handling Policy  are only applicable to public hospitals and the list is about risk of diversion (by staff) not risk to patients when treated with these medicines. The additional controls are through policy documents that are mandatory for WA Health sites and the restrictions are about storage and record keeping. Some private hospitals have policies that reflect the requirements of the WA Health policy. The list is in the Risk based requirements for medicines handling (Section 3).

More information

Medicines and Poisons Regulation Branch
Mailing address: PO Box 8172, Perth Business Centre, WA 6849
Phone: 9222 4424 (Monitored Medicines Prescriber Advisory Line)
Email: MPRB@health.wa.gov.au