The Medicines and Poisons Bill 2019 and related draft regulations were introduced to the Legislative Assembly on 14 May 2019. The Medicines and Poisons Act 2019 (Act) together with the Therapeutic Goods Act 2019 were passed by the Queensland Parliament on 17 September 2019 and will start on proclamation.
The purpose of the Act is to establish a new regulatory framework to modernise and streamline the regulation of medicines and poisons in Queensland.
The primary objective of the new framework is to ensure that any activity performed with a substance must be performed in an authorised manner. The Act regulates all substances listed as medicines and poisons in the Commonwealth Standards for the Uniform Scheduling Medicines and Poisons (SUMP). This standard classifies substances into “schedules” from schedule 2 to schedule 10 based on risk and the level of regulatory control required. The Act adopts the SUMP classification which promotes national consistency.
Introduction of Real-Time Prescribing
One of the big-ticket items of the Act is that it provides a head of power for the establishment of a real-time prescribing monitoring scheme. The purpose is to align with other jurisdictions and meet Queensland’s obligations under a national agreement to manage the use of dependence forming medicines.
The new framework requires that before prescribing or supplying a “monitored medicine”, prescribers will be required to check the monitored medicines database to establish if the person has previously been prescribed or supplied with the monitored medicine. Further, before dispensing or giving a treatment dose of a monitored medicine, dispensers will be required to check the database to see if the person has previously been prescribed or supplied a monitored medicine.
Monitored medicines are defined in the new Medicines and Poisons (Medicines) Regulation 2019 (Regulation) as follows:
- An S8 medicine; and
- The following S4 medicines:
- all benzodiazepines;
- gabapentin (Neurontin);
- pregabalin (Lyrica);
- quetiapine (Seroquel);
- zolpidem (Stilnox); and
A failure by a prescriber or dispenser to check the database before prescribing or dispensing a monitored medicine is an offence with a maximum penalty of 20 penalty units (currently $2,669).
Currently it is anticipated that the real-time prescription monitoring system will be available for use by Queensland prescribers and pharmacist in the second half of 2020.
Self-Prescribing of certain medicines will now be an offence
The Act also provides that it is an offence to self-prescribe or administer “high-risk medicines” without a reasonable excuse. The maximum penalty is 100 penalty units (currently $13,345).
The definition of “high-risk medicines” set out in the Regulation mirrors that of monitored medicines set out above.
Section 40 gives two examples of a reasonable excuse as follows:
- If a person authorised to prescribe a high-risk medicine is injured in an accident and asks someone else to urgently administer a high-risk medicine that is an analgesia to the injured person; and
- If a person authorised to prescribe a high-risk medicine self-prescribes the medicine because the person urgently needs it to avoid a break in the person’s regular treatment for a seizure disorder.
Other offences include:
The offence of administering a medicine unless it is administered in the authorised way (as set out in the Act) without a reasonable excuse. Maximum penalty = 200 penalty units (currently $26,690)
The offence of dealing with a prohibited substance (and S9 or S10 substance) unless the person deals with that substance in an authorised way (as set out in the Act) without a reasonable excuse. Maximum penalty 750 penalty units (currently $100,087.50)
The offence of disposing of waste from an S8 medicine unless the disposal is done by giving it to an authorised person or is disposed of in the authorised way (as set out in the Act). Maximum penalty 200 penalty units (currently $26,690)
While a new framework is being introduced the intention is to modernise and streamline the regulation of medicines to ensure that the requirements are easier for industry and the community to understand and apply in practice.
You should seek advice on any specific issues or questions about how the new framework may affect you or your practice.
This article was written by Katharine Philp, Partner.