Pharmaceutical opioids will be restricted to smaller pack sizes from next year as part of a TGA initiative to reduce overdose harms.
Products such as fentanyl, oxycodone, morphine, tramadol as well as codeine, hydromorphone, tapentadol, buprenorphine and methadone will be affected by a raft of changes recommended by TGA’s Opioid Regulatory Advisory Group (ORAG).
The changes, to be introduced from January 2020 include:
- Smaller pack sizes for immediate-release prescription opioid products to minimise risk of unused doses being diverted for illicit use.
- Tightening of the indication for fentanyl patches to avoid use in opioid naïve patients and to restrict their use to people with cancer, in palliative care and patients with exceptional circumstances.
- Boxed warnings and class statements in the Product Information (PI) documents for all prescription opioids in relation to their potential for harmful and hazardous use.
- Indications in the PI documents to reinforce that opioids should only be used when other analgesics have proven not to be effective.
- Safety information, including the relevant warnings prominently displayed in the Consumer Medicines Information (CMI)
However the regulator emphasised that the restrictions are aimed at inappropriate use of opioids in non-cancer pain, and people with cancer or in palliative care will still be able access the same opioid medications they need in the same way, with the same pack sizes as they do now.
Meanwhile, Australian drug and alcohol specialists have urged prescribers of pharmaceutical opioids for patients to also prescribe take home naloxone as an antidote for overdose.
They say that take home naloxone interventions are currently offered mostly to illicit opioid users even though pharmaceutical opioids are now responsible for far more deaths and poisoning hospitalisations in Australia.
Writing in Internal Medicine Journal they said clinicians should consider offering take home naloxone when prescribing opioids to patients at increased risk for overdose, including patients with a history of overdose, patients with a history of substance use disorder (eg alcohol), patients taking benzodiazepines with opioids (or) patients taking higher dosages of opioids (≥50mg daily oral morphine equivalents)
They noted that a recent Australian study involving 1514 chronic non-cancer pain (CNCP) patients prescribed S8 opioids that three-quarters had one risk factor and two-fifths had two risk factors for opioid overdose.
Naloxone is now available as an S3 over-the-counter medication and is more affordable when prescription, noted Dr Nick Lintzeris and colleagues from the National Drug and Alcohol Centre at the University of NSW.
“Doctors and pharmacists involved in providing opioid medications should become equipped in knowing how to educate their patients regarding preventing and responding to opioid overdoses, including the safer use of opioid and other sedative medications, and in the use of THN,” they concluded.