The Commonwealth Department of Health’s Therapeutic Goods Administration (“TGA”) is in the process of conducting a review into a possible regulatory response to the potential misuse of prescribed Schedule 8 opioids in Australia. Australia is ranked eighth internationally for daily doses of prescription opioids per million population.
The TGA acknowledges that strong opioids play a critical role in managing severe acute pain as well as pain experienced in many forms of cancer or other conditions, and therefore the response must not unduly restrict prescribing of these products.
Potential regulatory responses include changing pack sizing, restricting accessibility to the highest dose products, strengthening Risk Management Plans, reviewing label warnings and further education for health professionals.
Submissions for this review closed on 2 March 2018. The TGA will now consider the submissions and make recommendations.
Read more about the review here