New Medicines and Poisons Regulatory Framework in Queensland


This article applies to organisations in Queensland that store, supply and prescribe medicines, poisons and therapeutic goods.

Medicines and Poisons Act 2019 (Qld)

The Medicines and Poisons Act 2019 (Qld) (the Act) will commence on 27 September 2021 as part of an effort to modernise and streamline the regulation of medicines, poisons, prohibited substances, pesticides and fumigants in Queensland.

As a result of the commencement of the Act, the Health Act 1937 (Qld) and Pest Management Act 2001 (Qld) will be repealed. The Health (Drugs and Poisons) Regulation 1996 (Qld), Health Regulation 1996 (Qld) and Pest Management Regulation 2003 (Qld) will also be repealed and replaced.

Organisations should note that this article only covers the Act. It is expected that following the commencement of the Act, Regulations will be introduced. The new Regulations will support the Act by prescribing requirements for the lawful use, supply, storage and disposal of medicines. Once the Regulations commence, an interim update will be provided to incorporate the Regulations and to remove any topics that are being repealed in their entirety.

General Obligations

Organisations should ensure that staff are aware of new obligations imposed because of the Act. These include:

  • Section 32 (Offence to deal with prohibited substances), under which a person commits an offence if they deal with a prohibited substance in an unauthorised way or do not have a reasonable excuse. The maximum fine for violating this section of the Act is 750 penalty points ($103,387.50).
  • Sections 33 (Offence to manufacture medicines or hazardous poisons) and 35 (Offence to supply medicines or hazardous poisons), under these provisions, a person must not supply or manufacture a medicine or hazardous poison unless the person lawfully possesses the medicine or poison and supplies or manufacturers the medicine or poison in an authorised way. The maximum penalty for contravening section 33 of the Act is 750 penalty points ($103,387.50) and for section 35 is 500 penalty points ($68,925.00).
  • Section 34 (Offence to buy or possess S4 or S8 medicines or hazardous poisons) stipulates that if a person buys or possesses an S4 or S8 medicine or hazardous poison in an unauthorised way and without a reasonable excuse, then that person commits an offence. The maximum punishment for breaching this provision is 200 penalty units ($27,570.00).

As-of-Right Authorities

Organisations should note that the Act retains the as-of-right authority model through which authority is granted to a number of classes of persons to perform certain activities with drugs and poisons, (for example, to possess, supply or administer a medicine). However, the Act streamlines the model by grouping authority-holders by class and clarifying the scope of each authority. In this way, most of the existing authorities will be preserved. However, they will be translated into the new classification system with minor changes to reflect established shifts in the scope of practice.

Real-Time Prescription Monitoring

Chapter 7 (General) of Part 3 (Databases and registers) of the Act establishes a real-time prescription monitoring database (monitored medicines database). This database will enable prescribers and dispensers of certain dependence-forming medicines to review prescription and dispense records in real-time.

The purpose of the monitored medicine database is to promote safe practices concerning the therapeutic use of monitored medicines and reduce community harm caused by monitored medicines.

Organisations should note that the term monitored medicines is defined as any medicine prescribed by regulation to be a monitored medicine. However, we note that at the date of publication, no regulations have been introduced to define any medicines as monitored medicines.

Impact on Individuals

Organisations should ensure that their staff are aware that section 41 of the Act (Restrictions for monitored medicines) will impose an obligation on prescribers and dispensers to check the monitored medicines database before prescribing, supplying or dispensing a monitored medicine. Failure to check the database carries a penalty of 20 penalty units ($2,757).

Additionally, the monitored medicines database will be supported by section 226 of the Act. Under this section, information providers must provide information necessary for the database to the Chief Executive of Queensland Health within a prescribed time. Failure to comply carries a penalty of 100 penalty units ($13,785).

At present it is unclear what entities fall under the term information providers or what information they will be required to provide. These matters are expected to be covered in the new Regulations.

Substance Management Plans

Under the Act, certain authority holders are required to develop a substance management plan, being, ‘a document setting out how known and foreseeable risks associated with any dealing with a regulated substance are to be managed at the regulated place’.

The new substance management plan scheme recognises that there is no ‘one size fits all’ approach to risk management and is intended to ensure that risk-management systems for regulated substances and activities are dynamic and proportionate to the risk at the regulated place.

Organisations should be aware that under section 93 of the Act (Requirements for substance management plan), failure to develop a substance management plan before dealing with a regulated substance at a regulated place carries a maximum penalty of 250 penalty units ($34,462.50). Similarly, failure to make the plan available to staff or review the plan also carries the same penalty. Further, all staff that are bound by the plan must comply with the plan. Failure to do so carries a maximum penalty of 200 penalty units ($27,570).

However, organisations will have one year after the Act commences to comply with the substance management plan requirements in accordance with section 280 (Substance management plans) of the Act.

Conclusion

Organisations should ensure that their clinical and pharmacy staff are made aware of the new changes discussed above.


Contact

For further information please contact the Law Compliance team:

Phone: 1300 862 667

Email: info@lawcompliance.com.au