Monitored Medicines

The Monitored Medicines Prescribing Code and amended Medicines and Poisons Regulations 2016 came into effect on 12 December 2024. View a summary of the key changes.

The Monitored Medicines Prescribing Code (PDF 2MB) (formerly titled the Schedule 8 medicines prescribing code) governs the prescribing of Monitored Medicines in Western Australia (WA). The Monitored Medicines Prescribing Code (the Code) is published under the authority of the Medicines and Poisons Regulations 2016 (the Regulations), which are subsidiary legislation under the Medicines and Poisons Act 2014. The aim of the legislation is to protect public health through regulation of the supply of medicines and poisons.

The Code outlines situations where prescribers do not require prior authorisation of the CEO to prescribe S8 medicines to a patient. In all other situations, authorisation is required. The Code also outlines when prescribers who are prescribing Monitored Medicines are required to document a plan to mitigate potential harms associated with these medicines.

The Code and updated Regulations commenced on 12 December 2024.

Monitored Medicines

S8 medicines (controlled drugs)

  • Defined as “substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.”
  • Listed in Schedule 8 (S8) of the Poisons Standard (external site).

S4 Monitored Medicines (S4 Reportable Poisons)

Reporting requirements in relation to Drug Dependent and Oversupplied persons

Authorised health professionals have an obligation to report to the CEO when they have reason to believe that a patient is Oversupplied or Drug Dependent.

Written authorisation of the CEO is always required prior to prescribing an S8 medicine to a person who is recorded as drug dependent or oversupplied. 

Prescribing Monitored Medicines

Prescribers should recognise and work within the limits of their competence and scope of practice.

The prescribing of Monitored Medicines is limited to lawful practice of the health practitioner, any inherent professional scope or limitations imposed by the respective National Board, and the specific limitations of the Code (PDF 2MB). To be eligible to prescribe a Monitored Medicine, a prescriber’s professional registration must not have conditions or undertakings relevant to the prescribing of medicines.

The Code takes a risk-based approach to the regulation of Monitored Medicine prescribing. In certain circumstances, prescribing may:

  • not require interaction with the Department of Health (the Department);
  • require prescribers to carefully document a plan to mitigate harms associated with these medicines;
  • require authorised prescribers to notify to the Department that they are treating a particular patient;
  • require written authorisation from the Chief Executive Officer (CEO) before prescribing can commence.

Outlining important general conditions and recommendations, Part 1 of the Code is applicable to the prescribing and dispensing of all Monitored Medicines.

Before commencing treatment with Monitored Medicines

Prior to prescribing a Monitored Medicine, in line with Good Medical Practice: a code of conduct for doctors in Australia, it is recommended that the prescriber:

  • assesses the patient, taking an accurate medical history (including medication and substance history) and undertaking clinical examination and investigations as appropriate.
  • makes responsible and effective use of available resources, such as ScriptCheckWA (or the Monitored Medicines Prescriber Information Line) in combination with product information, recommendations, and best-practice guidelines that are current, approved, and published.
  • considers the balance of benefit and harm in management decisions.
  • has a clear diagnosis and indication for treatment. and
  • formulates, implements, and documents an appropriate management plan, which considers all available treatment options including non-pharmacological strategies, regular review, mitigation strategies where there is a risk of overdose, diversion, or substance use disorders, and the need for a Treatment Contract (Word 415KB)

Notifications of stimulant induced psychosis

A psychiatrist who makes a diagnosis of stimulant induced psychosis in respect of a patient must notify the CEO. The notification must be in writing, in the approved form, and must be forwarded to the Department within 72 hours of making the diagnosis.

Written authorisation from the CEO is required to prescribe an S8 stimulant medicine or medicinal cannabis product for a person with a current, or prior, history of psychosis. The treatment must be medically indicated.

Monitoring

Records of Monitored Medicines prescribed and dispensed in Western Australia are collected and maintained by the WA Department of Health. These records are available in the ScriptCheckWA. The records are routinely reviewed for compliance with the Regulations and the Code. Further detail is available in Section 1.8 of the Code.

In particular, the records are scrutinised to identify instances of problematic patient use and bring these to the attention of prescribers. The department will contact prescribers in any case where:

  • prescribing is not consistent with the Code
  • authorisation is required but not obtained
  • prescribing is not consistent with the authority issued
  • multiple prescribers (at different practices) are involved
  • the prescriber is supplying prescriptions in excess of the dose prescribed.

More information

Medicines and Poisons Regulation Branch
Mailing address: PO Box 8172, Perth Business Centre, WA 6849
Phone: 9222 4424

Email: MPRB@health.wa.gov.au