The Department of Health has announced the establishment of a Therapeutic Goods Administration (TGA) regulatory group to tackle the growing problem of pharmaceutical opioid abuse, which now claims more lives than heroin in Australia each year.
In a statement, the Department said there were three deaths, nearly 150 hospitalisations and 14 emergency department admissions involving opioid harm every day in Australia.
“These figures are too high, and the Australian Government has asked the TGA to play a role in tackling the problem,” the Department said.
“To help reduce the harm, we conducted a public consultation on prescription opioids in 2018.”
“A total of 98 submissions were received with feedback indicating strong and consistent support from all stakeholders for a regulatory response,” the Department said.
The Department said that following the initial consultation, the TGA established the Opioid Regulatory Advisory Group (ORAG), which included representatives from a range of health professional and consumer organisations.
“Throughout the process, it has been recognised that opioids play an important role in providing pain relief for many people and there has been a focus on ensuring appropriate and safe access is maintained,” the Department said.
As a result of the consultation, smaller pack sizes will be available for immediate-release prescription opioid products and sponsors will be required to include boxed warnings and class statements in the Product Information (PI) documents for all prescription opioids.
The Department said that these and other measures would align with broader Government initiatives to improve appropriate pain management, particularly the National Strategic Action Plan for Pain Management.
