Medicines, Poisons and Therapeutic Goods Bill 2013

The Medicines, Poisons and Therapeutic Goods Bill 2013 is the proposed successor legislation to the Poisons Act 1964.  The Bill is in advanced stages of progression to becoming new law.

 

The AMA (WA) has prepared a submission to the Bill, focussing on concerns with the definition of a drug dependent person and the obligations of doctors to report the drug dependent status of a patient.

 

The current Act is supported by subsidiary legislation, the Poisons Regulations 1965, which sets out controls over poisons in more detail.  The Bill will require similar regulations and the WA Department of Health Pharmaceutical Services Branch has invited the AMA (WA) to consult into the development of the Regulations.

 

Regulations set out the detailed controls to protect the public from harms associated with medicines and poisons.  Some of the existing Regulations may be retained or amended to reflect different aspects of the Bill and, where appropriate, new regulations may be required.

 

The Regulations are intended to protect the public from harms associated with certain toxic substances.  Types of controls in current Regulations include:

• Only trained persons can obtain, supply or use a poison
• Safe or secure storage to prevent public access
• Safe disposal
• Packaging requirements to prevent poisoning (e.g. in children)
• Labelling requirements to alert consumers
• Record keeping for supply
• Reporting requirements
• Advertising restrictions

 

Review of the Schedule 8 (S8) regulatory framework in WA (the Schedule 8 Medicines Prescribing Code) is also under discussion with the aim being to reduce the potential for diversion and abuse of S8 medicines without impeding access to S8 medicines for patients with genuine pain.

 

The AMA (WA) recently attended a forum with key stakeholders including Pain and Palliative Care specialists, Addiction Medicine specialists, General Practitioners, Geriatricians and Department of Health staff, to ensure the framework is in line with the Bill and best practice guidelines.

 

The Pharmaceutical Services Branch of the Department of Health is consulting over the development of new subsidiary legislation and asking the AMA (WA) for its views about the Regulations.

 

The following documents provide more information:

Current Regulations

Discussion Paper for the Regulations

Schedule 8 Medicines Prescribing Code

The Bill

The Act

 

If you have any questions, phone or email Chris Kane, Executive Officer, AMA (WA) on 9273 3060 or chris.kane@amawa.com.au

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