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State-based legal requirement for Schedule 8 prescriptions: why so complicated?

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Inconsistent prescription requirements between Australian states and territories create unnecessary complexity for health professionals

In Australia, medicines defined as Schedule 8 (S8) under the Standard for the Uniform Scheduling of Medicines and Poisons are strictly regulated because of the high risk of misuse and/or physical and psychological dependence associated with them.1 They have to be prescribed, dispensed, documented and destroyed in specific ways that are in compliance with each state and territory’s different drug regulations. S8 medicines are under stricter control than Schedule 4 (S4) medicines (other prescription-only drugs), for which requirements have been standardised between states and territories.2,3

Australia has no central body to regulate the handling of S8 drugs. Although the Therapeutic Goods Administration (TGA) is the national body for the regulation of medicines, each state and territory self-regulates under the general principles established by the TGA and has its own interpretation and legislation regarding S8 drugs, resulting in varied prescribing requirements. The legal requirements for obtaining authority and writing prescriptions for S8 medicines are listed in Box 1 and Box 2: they are often difficult to…