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Pharmacists to add warning labels to opioids


Matt Woodley


28/07/2020 4:13:50 PM

The labels will advise patients of the risk of overdose and dependence associated with the potentially dangerous medications.

Pharmacy shelf with opioid medication.
Opioids are being overused for chronic non-cancer pain in Australia.

The new cautionary advisory labels (CALs) will be applied by pharmacists at the time of dispensing, and are intended to help counsel patients about the safe and effective use of medicines.
 
An opioid medicines patient information handout has also been developed as an additional counselling aid.
 
Both initiatives stem from a 2018 Therapeutic Goods Administration (TGA) consultation paper that investigated regulatory options to prevent opioid misuse in Australia.
 
Associate Professor Mark Morgan, Chair of the RACGP Expert Committee – Quality Care (REC–QC), told newsGP that opioids are being overused for chronic non-cancer pain in Australia, and said prescribing should be ‘wrapped up’ with a plan for de-prescribing.
 
‘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.
 
‘Before starting, and at each review of opioid prescriptions, there should be a careful weighing up of pros and cons. This should include a discussion with the patient about the potential harms and risks, and realistic expectations from using the medication.
 
‘Prescribing for acute nociceptive pain – for example, after an injury or surgery – should be for just a few days with close review. Smaller pack sizes will help this shift.’
 
In a letter to the RACGP, Pharmaceutical Society of Australia (PSA) President Associate Professor Christopher Freeman said the use of opioid CALs and the patient information handout have been endorsed by the TGA Opioid Regulatory Advisory Group (ORAG).
 
‘The opioid CAL and opioid medicines patient information handout will be published in the Australian Pharmaceutical Formulary and Handbook [APF],’ he wrote.
 
‘The APF 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.’
 
While noting there is the potential for conflicting advice between the prescribing doctor and the warnings passed on by pharmacists in the form of the leaflet, Associate Professor Morgan said this mismatch should be avoided by a careful and comprehensive approach to prescribing opioids.
 
He added that it ‘makes sense’ to explore non-opioid options for pain relief in all patients, with an emphasis on non-drug treatments, and the RACGP’s Handbook of Non-Drug Interventions (HANDI) is a valuable resource to assist with this approach.
 
‘If opioids are used then it is vital the patient and any carers understand how to recognise early signs of overdose,’ he said.
 
‘It is also very important for patients to understand the cumulative effect of different sedating medications and alcohol.
 
‘Naloxone availability and instruction is still missing as a component of safer opioid prescribing.’
 
The RACGP’s Drugs of dependence: Responding to requests provides more GP-specific information.
 
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Dr Franziska Levin   29/07/2020 9:15:27 AM

This would be useful for benzodiazepines too.