New formats needed 
Clinical trial data released this year in a study of cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth showed that using lenacapavir results in a 96% 
‘In my view, it’s analogous to dispensing a new drug that you haven’t come across before. You understand the relevant information related to the drug from a safety and effectiveness point of view, you communicate with the patient regarding relevant counselling points, and you document relevant information.’
In line with Therapeutic Goods Administration (TGA) regulatory changes to enhance medicine safety, PSA has developed a cautionary advisory label (CAL) that warns consumers about the risk of opioid overdose and dependence.
The CAL (Label 24, at right) can be applied to opioid medicines at the time of dispensing as an aid to counselling patients about the safe and effective use of opioids. An Opioid medicines patient information handout has been developed as a counselling aid.
The CAL is recommended for opioid medicines, including buprenorphine, codeine, dihydrocodeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, tapentadol, and tramadol.
Pharmacists are advised to provide the Opioid medicines patient information handout to any patient receiving opioid medicine that carries Label 24.
Two rolls of Label 24, a copy of the patient handout and a letter to pharmacists were posted this month to all community and hospital pharmacies.
PSA General Manager Knowledge Development Stefanie Johnston MPS said the CAL could help pharmacists speak to their patients about medicine safety.
‘Label 24 provides a new opportunity to have open conversations with your patients about the safe use of opioids,’ she said.
‘I encourage all pharmacists to incorporate it into their practice.’
CPD material about Label 24, the patient handout, TGA opioid regulatory reforms and safe and effective use of opioids has been developed by both PSA and the Society of Hospital Pharmacists of Australia and is expected to be available from next month.
Emeritus Professor Lloyd Sansom AO FPS, chair of the Australian Pharmaceutical Formulary and Handbook (APF) editorial board, chaired the stakeholder roundtable meeting that led to the development of the CAL and patient handout.
As chair of the editorial board as well as the APF’s New Drugs Advisory Group (NDAG), Professor Sansom has approved publication of both documents in the APF.
The CAL and patient handout were reviewed by the 10 pharmacist members of the APF NDAG as well as the Professor of Medicines Use Optimisation at the University of Sydney School of Pharmacy Parisa Aslani FPS.
Professor Aslani has expertise in patient counselling and education, including consumer medicines information (CMI).
The new TGA regulations require opioid sponsors to update prescribing indications for opioids to ensure patients are prescribed opioids only where the benefits outweigh the risks.
They also require sponsors to add additional warning statements to Product Information and CMI for all opioids. This is so prescribers and consumers are reminded of the appropriate circumstances for opioid prescribing and potential adverse effects.
Sponsors must also now register smaller pack sizes for immediate-release opioids that provide a more appropriate option for short-term pain relief.
Exisiting larger pack sizes will remain available for patients who need them.
For more information, visit www.tga.gov.au/alert/prescription-opioids.
