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Investigation report – Undoing the knots constraining medicine regulation in Queensland

This report details the investigation undertaken by the Health Ombudsman into the appropriateness and effectiveness of the Queensland regulatory system for scheduled medicines as it applies to health services, in particular the prescribing and dispensing of schedule 8 medicines. The investigation commenced after a number of complaints displaying common trends were received by the Office of the Health Ombudsman relating to prescribing and dispensing of scheduled medicines.

During these investigations, concerns were raised about the timing and adequacy of regulatory actions and of the dissemination of information to other relevant regulatory bodies. In particular, the Health Ombudsman was concerned about what appeared to be significant delays in taking appropriate action. As a result, the Health Ombudsman commenced an own-motion systemic investigation under section 80(c) of the Health Ombudsman Act 2013 to review the system and its apparent inadequate, timely regulatory responses to prescribing and dispensing of schedule 8 medicines that posed a risk to the health and safety of the public.

During the systemic investigation, the Health Ombudsman sought input from a range of stakeholders including Medicines Regulation and Quality in the Department of Health, Australian Health Practitioner Regulation Agency, Queensland Police Service, Office of the State Coroner, Pharmacy Guild of Australia, Pharmaceutical Society of Australia, Society of Hospital Pharmacists of Australia, and the 16 Hospital and Health Services in Queensland.

The investigation identified that the regulatory framework for managing safe and appropriate access to schedule 8 medicines is complex, with responsibility shared across national and state levels and across multiple agencies. In Queensland, prescribing and dispensing is primarily regulated by Medicines Regulation and Quality, which has legislative responsibility under the Health Act 1937 and its subordinate legislation for monitoring the prescribing, dispensing and use of schedule 8 medicines in Queensland.

The Health Ombudsman’s examination of the framework for regulating schedule 8 medicines in Queensland highlighted a number of areas of actual or potential risk. Of particular note, the investigation identified deficiencies in the coordinated inter-government department approach—in particular, the coordination of roles and responsibilities between relevant agencies involved in regulating and responding to emerging prescribing and dispensing concerns with schedule 8 medicines.

The Health Ombudsman has made 16 specific recommendations which propose suggested solutions and risk mitigation strategies. These recommendations are primarily focused on areas of legislative complexity, roles and responsibilities, policies and procedures, communication and collaboration, and real time prescription monitoring.

Area of concern Health Ombudsman’s recommendations
1. Legislative complexity The Health Ombudsman recommends that the Director-General of the Department of Health:

1. Continues to actively consult with stakeholders on the proposed new framework for the regulation of medicines, poisons and therapeutic goods in Queensland, in particular in relation to the prescribing and dispensing of schedule 8 medicines.

2. Takes into account the issues identified in this report in his consideration of the proposed new legislation.

3. Following the introduction of the new Medicines, Poisons and Therapeutic Goods Act, ensures that Queensland Health works closely with stakeholders—including national health practitioner boards, QPS, professional associations and organisations such as the Private Hospitals Association of Queensland—to implement a tailored education program aimed at each stakeholder group to ensure all are aware of their obligations under the new legislation.

4. Ensures MRQ continues and strengthens its work with the QPS to ensure adequate guidance is provided to QPS officers about the misuse of scheduled medicines and the availability of various charges, as well as the practical consequences of bringing charges under a particular Act.

5. Considers recommending to the Queensland Minister for Health to propose at the next Australian Health Ministers’ Conference that amendments are made to the National Law to require practitioners disclose to their national board if the practitioner has been charged or convicted of an offence under drugs and poison legislation, whether in a participating jurisdiction or elsewhere.

2. Roles and responsibilities The Health Ombudsman recommends that the Director-General of the Department of Health:

6. Establishes a committee to undertake a review of the roles and responsibilities of MRQ in light of the roles and responsibilities of the other agencies involved in regulating schedule 8 medicines. The review committee should include representatives from all key stakeholder groups including MRQ, my office, AHPRA, QPS, the Office of the State Coroner and Hospital and Health Service public health units. This review should consider:

a. whether MRQ maintain each of its administrative, educative, therapeutic, and monitoring and enforcement functions
b. which agency within the regulatory environment is best equipped to take on the lead role in relation to each function
c. the identification of shared performance indicators, reporting arrangements and outcomes, where possible
d. the creation of appropriate governance arrangements to support decision-making and performance monitoring.

Subject to the outcome of the review, the Health Ombudsman recommends that the Director-General of the Department of Health:

7. Considers the development and documenting of a formal agreement setting out a clear statement of shared purpose and agreed roles and responsibilities of each of the agencies.

8. Ensures that MRQ, my office, AHPRA, QPS, the Office of the State Coroner, and Hospital and Health Services public health units communicates the agreed roles and responsibilities of each of their respective agencies clearly and regularly to all agency staff.

9. Reviews current resourcing levels and determines the resources required for MRQ to appropriately perform its functions.

10. Identifies trigger points for information sharing and referral between agencies in consultation with key agencies including MRQ, my office, AHPRA, QPS, the Office of the State Coroner and Hospital and Health Services public health units.

11. Directs MRQ to review its compliance and enforcement framework and to undertake a current risk assessment of work practices, including surveillance thresholds and criteria, at regular, prescribed intervals.

3. Policies and procedures The Health Ombudsman recommends that the Director-General of the Department of Health:

12. Directs MRQ to review its existing documentation and develop a consolidated and current authoritative version of all policies and procedures.

4. Communication and collaboration The Health Ombudsman recommends that the Director-General of the Department of Health:

13. Coordinates a consultation process to develop formal written multi-agency agreements that outline mechanisms for the exchange of information about schedule 8 medicine matters, and that these agreements include are requirement for regular review.

14. Coordinates regular formal liaison meetings between key stakeholders including my office, AHPRA, MRQ, the QPS and the Office of the State Coroner (at least every two months initially).

15. Explores changes to legislation to improve the ability of agencies involved in schedule 8 medicine management to share relevant and confidential information to improve the timeliness of risk mitigation strategies to ensure health and safety of the public.

5. Real time prescription monitoring The Health Ombudsman recommends that the Director-General of the Department of Health:

16. Directs an expeditious review of Queensland Health’s options for the introduction of a RTPM system in Queensland and the subsequent development of a business plan to progress the implementation of a RTPM system.

Download the full report

For media: download media statement