Opioid pack size review

THE Therapeutic Goods Administration (TGA) has commenced a review of opioids commonly used to treat acute pain in the home setting, to consider whether registered pack sizes align with the requirements for their intended short-term use.

The plan is one of the outcomes of the TGA’s consultation on opioids (PD 23 Jan 2018) which saw almost 100 submissions received from government bodies, industry suppliers, health professionals and other organisations.

The TGA said there was “strong and consistent support” for four of the proposed options in the consultation paper, including the pack size review, looking at indications for opioid products used to treat pain, reviewing label warnings and Consumer Medicines Information, as well as working to raise health professional and consumer awareness about pain management guidelines and nonopioid alternatives for chronic pain.

If suitable pack sizes for postsurgical or injury acute pain treatment are not available, the TGA said it would work with sponsors to support them in registering smaller pack sizes of these products.

“Importantly, this review is not considering restriction of larger pack sizes for products that are registered to treat chronic pain, including cancer pain,” the TGA said.

A review of the Product Information for opioid products is also under way, with a focus on the currently approved indications taking into consideration current clinical guidelines, responses to the public consultation and warnings provided in comparable overseas medicines information documents - particularly relating to Fentanyl which has been identified as an opioid of particular concern for abuse and misuse.

Consumer Medicines Information documents for opioids are also under review, focusing on how clearly the risks of addiction and overdose are conveyed, while the TGA has also flagged the creation of a plan to raise awareness and educate health professionals about pain management guidelines.