Medicines and poisons legislation

Mr Neil Keen

In WA, the Poisons Sale Act of 1879 sought to restrict the sale of a small number of dangerous poisons, covering 15 substances including arsenic, strychnine, cyanide, chloroform, belladonna and opium. In 1910, it was superseded by the Pharmacy and Poisons Act, which not only expanded the list of substances but also registered pharmacies. In 1964, an updated Poisons Act classified poisons according to broad risk categories and started to shape the contemporary prescriber and dispenser relationship.

On 30 January this year, the Medicines and Poisons Act 2014 and the Medicines and Poisons Regulations 2016 came into effect, replacing the ageing Poisons Act. It continues to regulate the manufacture, sale and use of medicines and poisons. In practice, it provides the legal framework that underpins the medicines supply chain and the basis for prescribing and dispensing of medicines.

The modernised legislation is simpler, easier to understand and more flexible. Key concerns addressed are those of national consistency and less red tape. For most practitioners, there will be limited day-to-day impact, however it provides for greater flexibility in handling medicines, designed to make the most of the current and future health workforce.

Major changes to the Act include an overhaul of licences and permits. The Act extends powers to collect and share information on Schedule 8 medicines, important for plans to introduce real-time reporting. The Act permits the notification of doctor shoppers and provides the ability to restrict supply to these persons.

The most obvious changes are within the Regulations. One major difference is the addition of health practitioner groups to permit them to work with medicines, including paramedics and Aboriginal health practitioners.

For the most part, the requirements for writing a prescription have not changed. A key reform has been to remove the requirement to handwrite details on computer generated prescriptions for Schedule 8 medicines, although pharmacists may be required to confirm authenticity in some cases. The Regulations also pave the way for secure electronic prescriptions and permit more choice in medication chart use in aged care facilities.

Under the previous legislation, the long-term prescribing of Schedule 8 medicines required authorisation by the Department of Health. In many cases, this is no longer required, so long as practitioners comply with a published Code. Authorisation will still be necessary for anyone notified as drug dependent and for certain high risk drugs, doses or formulations. The Department will continue to monitor these prescriptions and engage with prescribers on matters of concern.

An important initiative has been to codify a framework for Structured Administration and Supply Arrangements. These are colloquially referred to as “standing orders”, but until now were not legally recognised in Western Australia.

The Department of Health’s guidance documents will assist health practitioners on all aspects of the new legislation and can be accessed at www.health.wa.gov.au/pharmacy.

 

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