Reducing opioid harm through regulatory changes

Information for consumers, patients and carers

The Australian Government, through the Therapeutic Goods Administration (TGA) within the Department of Health, is implementing a number of regulatory changes in order to minimise the harms caused by opioid prescription medicines to Australians each year. The changes will ensure the safe and effective prescribing and use of opioids while maintaining access for patients who need them.

Why the changes are being made

Over the past decade, Australians have experienced a significant increase in the level of harm and deaths arising from the use of pharmaceutical opioids. Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve issues relating to opioid use, and three people die from the harm that results.

Opioids can be an effective component of the management of short-term and cancer-related pain. However, the evidence shows that for most people with long-term non-cancer pain, opioids do not provide clinically important improvement in pain or function compared with other treatments. Instead, they carry significant risk of harm, even when used as directed.

The regulatory changes aim to reduce the harms from opioids by reducing the number of people who start opioid treatment for short-term pain, for example following injury or surgery, and then continue to use the medicine long-term where the risk of harm outweighs benefit. The changes will also allow doctors (and other health professionals who prescribe opioids, such as nurse practitioners) to implement best-practice opioid prescribing for people living with pain while ensuring adequate pain management.

For people who are gaining little benefit from opioids or who are experiencing harm, doctors will be encouraged to work in partnership with their patients to safely reduce their opioid treatment over time to either stop the opioid medicine or ensure the best dose is found that effectively treats their pain while minimising the risk of side effects.

Many people who reduce or stop their use of opioids find that their lives improve. They can think more clearly and are more alert. Some people find their mobility is better and they are steadier on their feet. Less reliance on medication reduces trips to the pharmacy and may save money. 

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