New warning labels for opioids


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Pharmacists are being encouraged to use the newly available labels for opioid products, which have been designed to spark conversations with patients about risks

PSA has worked with the TGA over recent months to develop a cautionary advisory label (Label 24) which it says supports the Australian Government’s strategy to reduce the harm of opioids.

The label is recommended for opioid medicines including buprenorphine, codeine, dihydrocodeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, tapentadol, and tramadol.

An opioid medicines patient information handout has also been developed as an additional counselling aid.

Emeritus Professor Lloyd Sansom AO FPS led the Australian Pharmaceutical Formulary and Handbook (APF) editorial board, which oversaw the development of the cautionary advisory label and patient handouts.

Two rolls of Label 24, a copy of the patient handout and a letter to pharmacists have been sent to community pharmacies and hospital pharmacies around Australia.

“Label 24 should be used for all opioid medicines including codeine, morphine and fentanyl,” PSA national president Chris Freeman told AJP.

“Label 24 aims to better inform patients about the risks of their medicines and promote open and honest conversations with their pharmacist.”

“As Australia’s most accessible health professionals, pharmacists have a crucial role in guiding their patients’ safer use of medicines.”

A/Prof Freeman said PSA is committed to supporting more informed and transparent conversations between pharmacists and their patients.

“I encourage all pharmacists to incorporate Label 24 and the associated resources in the digital APF and the pain models developed in collaboration with SHPA into their daily practice,” he said.

Associate Professor Mark Morgan, Chair of the RACGP Expert Committee – Quality Care, told newsGP that opioids are being overused for chronic non-cancer pain in Australia.

“There needs to be a cultural shift away from the use of opioids for most chronic non-cancer pain because there are enormous personal risks, identifiable harms and societal costs from having such high levels of use,” he said.

In a letter to the RACGP, A/Prof Freeman said the Australian Pharmaceutical Formulary and Handbook advises pharmacists to use their knowledge and professional judgement in deciding whether to use the opioid CAL, and whether to provide the opioid medicines patient information handout for a specific patient or circumstance.

“Please advise your members that pharmacists may apply the opioid CAL to opioid medicines at the time of dispensing, and may provide patients with the opioid medicines information handout,” he said.

Various measures have been recently taken by the government to reduce opioid harm, including new TGA regulations from 1 June that saw changes to opioids pack sizes and availability.

Regulatory changes have also required opioid sponsors to add additional warning statements to the approved Product Information and CMI for all opioids; and update prescribing indications for opioids to ensure patients are prescribed an opioid only where the benefits outweigh the risks.

For more information see the pain models PSA has developed in collaboration with SHPA  https://www.psa.org.au/talking-pain/

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