Specific strategies for monitored and high-risk medicine offences

Monitored medicines and high-risk medicines are specified in Schedule 2, Part 4 and Schedule 2, Part 2 of the Medicines and Poisons (Medicines) Regulation 2021 (MPMR), respectively. Currently, the lists of monitored medicines and high-risk medicines are identical, comprising:

Queensland Health has implemented a range of regulatory strategies relevant to particular monitored and high-risk medicine offences, summarised below.

Please note, this is not an exhaustive list of all regulatory activities undertaken by Department of Health and Hospital and Health Services regulatory officers. The strategies are indicative only and may be modified at any time without notice.

Download the Regulatory framework for medicines offences (PDF 542 kB) for more information about these strategies.

Not look-up (NLU) Strategy

Section 41 of the Medicines and Poisons Act 2019 (MPA) requires that before prescribing, dispensing or giving a treatment dose of a monitored medicine for a person, relevant practitioners must check the monitored medicines database (QScript) to see whether information recorded in the database shows that the person has previously been prescribed, dispensed or given any monitored medicine, unless:

• an exemption (specified in regulation) applies; or
• the relevant practitioner has a reasonable excuse.

The NLU Strategy aims to promote and support compliance with the requirement for relevant practitioners to check QScript. It involves both proactive and reactive compliance monitoring:

• Reminder to register: This approach focuses on relevant practitioners who are identified as prescribing or dispensing monitored medicines who are not registered for QScript.
• Reactive approach: Queensland Health may undertake a reactive review of a relevant practitioner’s QScript usage in response to triggers such as a complaint or a coronial information request.
• Proactive, ‘top-down’ approach: Proactive monitoring of compliance with QScript look-up requirements is focused on the highest risk prescribers and dispensers who frequently fail to check QScript.

Monitored Medicines Standard (MMS) Strategy

Under Section 93 and Section 126 of the MPMR, health practitioners must comply with the departmental standard called ‘Monitored medicines’ (the Monitored Medicines Standard (PDF 320 kB)):

• when prescribing a monitored medicine to be dispensed or given as a treatment dose for a patient; or
• when dispensing a monitored medicine for a patient.

The MMS Strategy aims to promote and support compliance with the requirement for prescribers and dispensers to comply with the MMS.

• Reactive reviews of a practitioner’s MMS compliance may be undertaken e.g. in response to a complaint.
• A proactive compliance monitoring strategy for version 2 of the MMS (in effect from 1 July 2024) is currently being developed.

Self-prescribe (SP) Strategy

Section 40 of the MPA includes a specific offence for self-prescribing and self-administering high-risk medicines.

The SP Strategy focuses on health practitioners identified as self-prescribing a high-risk medicine. It involves both proactive and reactive compliance monitoring.

Amfetamines and Methylphenidate (AM) Strategy

The prescribing of amfetamines and methylphenidate (collectively referred to here as psychostimulants) is subject to range of controls specified in the MPA and MPMR.

While some health practitioners have as-of-right authority to prescribe psychostimulants in certain circumstances, in most cases, a practitioner seeking to prescribe these medicines is required to hold a prescribing approval, issued under Section 67 of the MPA, authorising this. View the Prescribing psychostimulants (PDF 195 kB) fact sheet for more information.

The AM Strategy aims to ensure psychostimulants are only prescribed by authorised persons in authorised circumstances.

Proactive monitoring is regularly undertaken using a risk-based approach, with a focus on general practitioners identified as having prescribed psychostimulants without a prescribing approval on a specified number of occasions (i.e. above a specified threshold) during a specified monitoring period.

Reactive monitoring (e.g. in response to a complaint) is also undertaken where appropriate.

Managing reports and notifications

Chapter 8, Part 5 of the MPMR requires persons dealing with medicines to report particular matters to the chief executive in a range of circumstances (e.g. when the loss or theft of a Schedule 8 medicine is suspected or when prescriptions or purchase orders are suspected to be unlawful e.g. false or fraudulent).

All reports and notifications of this nature are recorded, assessed and—if necessary—investigated and managed by authorised officers.

Individuals can use online approved forms on the Reporting medicines matters to the chief executive page to meet their reporting and notification requirements under the MPA and MPMR.

The management of reports and notifications is a reactive regulatory activity, and no structured proactive monitoring of compliance with notification requirements is undertaken. However, Queensland Health may undertake a reactive review of a person’s compliance with notification requirements in response to triggers such as a complaint or a coronial information request.