The TGA has commenced reviews into pack sizes, indications and label warnings for S8 opioids

In response to rising numbers of opioid prescriptions and levels of overdose reaching “record levels”, the TGA launched a consultation into prescription opioid use and misuse early this year.

Its aim was to develop options for a regulatory response in this area, with a particular focus on strong (Schedule 8) opioids.

The TGA released a consultation paper that received 98 submissions including from the PSA, Pharmacy Guild, SHPA, AMA, CHF, Medicines Australia and ScriptWise among others.

After conducting additional targeted workshops to consult with stakeholders across the country, the TGA has now outlined its next steps.

Among responses to the consultation paper, the TGA says there was “strong and consistent” support for four of the proposed options:

Review of pack sizes

The TGA reports that it has commenced a review of opioids commonly used to treat acute pain in the home setting.

It will consider whether registered pack sizes align with the requirements for their intended short-term use, and if these products are available in Australia.

If suitable pack sizes are not available, the TGA says it will 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,” says the TGA.

Review of indications

The TGA has also commenced a review of the product information (PI) for opioid products indicated for use in treating pain, with a focus on the currently approved indications.

It will also consider whether appropriate warnings are included in the PI.

This review will initially focus on the appropriateness of the indications for very potent opioids such as fentanyl, which the TGA says has been identified “as an opioid of particular concern for abuse and misuse”.

Review of label warnings and CMI

The TGA has commenced a review of how the risks of opioids are communicated to consumers through the Consumer Medicines Information (CMI) document.

“The focus will be on how clearly the risks of addiction and overdose are conveyed to consumers, as well as determining whether information on safe disposal is accurate,” it explains.

Education for health professionals and consumers

The TGA aims to build on existing relationships with external stakeholders who provide education to health professionals and consumers.

“Together with these stakeholders we will develop a plan to raise awareness and educate health professionals about pain management guidelines, including the use of opioid alternatives,” says the TGA.

The organisation says that some respondents expressed concern that any regulatory action should not impair clinically appropriate access to opioid medications for treatment of chronic pain, including cancer-related pain.

“It is recognised that opioids are essential medicines that play a critical role in pain management,” says the TGA.

“In implementing the above options, Australian patients will be able to continue to access opioids appropriately and safely.”