The TGA has opened a consultation on options for a regulatory response to the potential misuse of S8 opioids
Australia is heading down a “similar” path to other countries which are experiencing crises in the widespread misuse of prescribed opioids, the TGA notes in the paper.
The paper examines the issues around prescription opioid use and misuse in Australia and explores options for a regulatory response to any issues identified.
Interested parties are invited to respond to the paper by Friday, 2 March 2018.
The consultation focuses on the higher-risk S8 opioids, though some S4 opioids may also be considered.
“Acknowledging that strong opioids play a critical role in managing severe acute pain following trauma and major surgery, as well as pain experienced in many forms of cancer and some other conditions, any regulatory response must not unduly restrict informed, rational prescribing of these products,” the TGA says.
“It is noted that use, and misuse, of opioids is affected by a wider range of factors beyond regulation, but regulation as it relates to demand from patients and supply from prescribers can play an important role in underpinning appropriate use and minimising misuse.”
The TGA points out that levels of prescription opioid overdose, including accidental overdose, are at “record” levels in Australia and internationally. These now exceed heroin deaths by two to two and a half times.
Between 2011 and 2015 there were 2145 deaths associated with oxycodone, morphine, codeine, fentanyl, tramadol and/or pethidine compared with 985 due to heroin.
The TGA says that “indication creep” – their use in a range of types of chronic non-cancer pain, despite limited evidence of efficacy or safety for opioids in many of those patients – is part of the problem.
“Use in chronic pain is also driven by the inconsistent efficacy of alternative medicines in chronic pain such as non-steroidal anti-inflammatory drugs (NSAIDs), gabapentoids, antidepressants and muscle relaxants; opioid analgesics are often used when pain is refractory to these other treatments. “Judicious prescribing for some patients with chronic non-cancer pain has been described as an appropriate option.”
Australia currently ranks eighth internationally on the numbers of defined daily doses of prescription opioids per million population – about 40% of the level of the USA, where opioid analgesics are now the most commonly prescribed class of medicines.
Possible options outlined in the paper (which the TGA highlights are not mutually exclusive) include:
- Option 1: Consider the pack sizes for strong (S8) opioids
- Option 2: Consider a review of the indications for strong (S8) opioids
- Option 3: Consider whether the highest dose products should remain on the market, or be restricted to specialist/ authority prescribing
- Option 4: Strengthening of the Risk Management Plans for opioid products
- Option 5: Review of label warnings and revision to Consumer Medicines Information
- Option 6: Consider incentives for expedited TGA review of improved products for pain relief and opioid antidotes
- Option 7: Potential changes to use of appendices in the Poisons Standard to provide additional regulatory controls for strong S8 opioids (this could potentially include controls of prescribing for particular populations or classes of medical practitioners, additional safety directions or label warning statements, specific dispensing labels).
- Option 8: Increase health professional awareness of alternatives to opioids (both S4 and S8 opioids) in the management of chronic pain.
Access the consultation paper here.