What it does
The Medicines and Poisons Regulations 2016 (WA) is the principal subordinate legislation under the Medicines and Poisons Act 2014. It establishes the detailed operational framework for the classification, handling, prescribing, supply, storage, and record-keeping of scheduled medicines and poisons in Western Australia. The regulations prescribe which substances fall into each Schedule (Schedule 2 through Schedule 9) by cross-referencing the current Poisons Standard under the Commonwealth Therapeutic Goods Act 1989, and by adding specific substances such as the extensive list of synthetic cannabinoids and other psychoactive substances in Schedule 2 to the regulations. They also classify strictly controlled substances by referencing Schedule 10 of the Poisons Standard.
The regulations set out the requirements for a document to qualify as a prescription, including mandatory content such as prescriber name, address and telephone number, patient name and address, date of birth for Schedule 4 and Schedule 8 poisons (with an exception where the supplier otherwise verifies the patient’s date of birth for Schedule 4), quantity, dose, strength, form, precise directions for use, and repeat information. Prescriptions may be issued in paper form (handwritten or computer-generated and signed in ink) or as electronic documents through an approved electronic prescribing system. Regulations also establish medication charts for hospital inpatients, hospital discharge, and residential care as valid forms of prescription in those settings.
The regulations authorise a wide range of health professionals to administer, possess, prescribe, supply or dispense scheduled medicines, with each profession’s scope defined in Part 7. They create a structured administration and supply arrangement (SASA) mechanism, allowing the CEO, health organisations, or medical practitioners to issue documents that specify when and by whom certain medicines may be administered or supplied, particularly for acute care or public health programmes. The regulations also govern licensing and permitting for manufacturers, wholesalers, retailers and users of poisons, including detailed storage, transport and disposal requirements, especially for Schedule 8 and Schedule 9 poisons where safes, strongrooms, detection devices and locked cabinets are mandated based on dose thresholds. Record-keeping and reporting obligations are extensive, including a requirement to register with and use a real-time prescription monitoring system before dispensing or prescribing a Schedule 4 reportable poison or Schedule 8 poison. Enforcement provisions include infringement notices for certain offences, such as the supply of Schedule 6 nitrous oxide.