This alert applies to organisations that store, supply and prescribe medicines, poisons and therapeutic goods and will likely amend the QLD – Drugs topic.
Medicines and Poisons Bill 2019 (Qld)
Please be advised that the Medicines and Poisons Bill 2019 (Qld) (the Bill) passed its Third Reading on 17 September 2019 and received Royal Assent on 26 September 2019. The Bill is due to commence on 27 September 2020 unless proclaimed earlier.
Currently, medicines and poisons in Queensland are regulated by the Health Act 1937 (Qld) (the Act) and the Health (Drugs and Poisons) Regulation 1996 (Qld) (Drugs and Poisons Regulation) and the Health Regulation 1996 (Qld). The Act is one of the oldest Acts currently in force in Queensland and the regulatory framework that it supports is similarly outdated and hampered by its piecemeal construction and unnecessary complexity.
The Bill proposes to repeal the existing framework and replace it with a suite of contemporary legislation intended to ensure that medicines and poisons regulations are accessible and that the requirements can be understood and applied in practice by the individuals working in the area (e.g. nurses and doctors).
Subscribers should note that much of the detail of the new framework will be included in regulations that will come into operation after the Bill commences. The proposed Medicines and Poisons (Medicines) Regulation 2019 (Qld) deals with medicines and will support the Bill by prescribing requirements for the lawful use, supply, storage and disposal of medicines.
Currently, the Drugs and Poisons Regulation grants authority to a number of classes of persons to perform certain activities with drugs and poisons. These as-of-right authorities are granted by reference to registration status (e.g. medical practitioner), position (e.g. person in charge of a nursing home), or qualification (e.g. qualified ambulance officer). These authorities are scattered throughout the Drugs and Poisons Regulation and it can be difficult to discern the nature and scope of each authority.
This Bill and the associated regulations will retain the as-of-right authority model, but it will be significantly streamlined by logically 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 scope of practice.
Real-Time Prescription Monitoring
Part 3 of the Bill will establish a real-time prescription monitoring database (monitored medicines database) that will enable prescribers and dispensers of certain dependence-forming medicines to review prescription and dispensing records in real-time when making clinical decisions.
The substances that will be monitored medicines will be defined by regulation and will include substances that are considered to carry a high risk of abuse and dependence, such as pharmaceutical opioids and other prescription-only medicines that are associated with abuse (e.g. certain sedatives).
To ensure that the monitored medicines database fulfils its harm reduction objective effectively, section 41 of the Bill 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 (currently $2,669).
Additonally, the monitored medicines database will be supported by section 226 of the Bill, which requires prescribed persons to provide the information required for the purpose of the database to the Chief Executive of Queensland Health within the prescribed time. Note that relevant persons and information will be prescribed by regulation after the passage of the Bill. Failure to comply with the obligation to supply information carries a penalty of 100 penalty units (currently $13,345).
Substance Management Plans
Certain prescriptive requirements currently imposed under the Drugs and Poisons Regulation will be repealed and replaced by a new requirement for certain authority holders to develop a ‘substance management plan’.
Section 92 of the Bill provides that a ‘substance management plan’ for a regulated place means ‘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 regulated activities are dynamic and proportionate to the risk at the regulated place.
The offences associated with the development of, and compliance with, a substance management plan are severe. Section 93 of the Bill provides that a failure to develop a substance management plan before dealing with a regulated substance at a regulated place carries a penalty of 250 penalty units (currently $33,362.50). Similarly, failure to make the plan available to staff or review the plan also carries a penalty of 250 penalty units. Further, all staff that are bound by the plan must comply with the plan and a failure to do so carries a penalty of 200 penalty units (currently $26,690).
Significantly, section 280 of the Bill provides that organisations will have 1 year after the Bill commences to comply with the substance management plan requirements.
Please click here to access the full Bill.
For further information please contact the Law Compliance team:
Phone: 1300 862 667