Chronic pain is a common condition thought to affect at least one in five Australians. While opioids have been increasingly used in this population, there is a lack of evidence to support their long-term efficacy.
A recent meta-analysis of 96 randomised clinical trials on opioid use in chronic non-cancer pain demonstrated no clinically important improvements in pain or function. Compared to placebo, opioid use was associated with a statistically significant improvement of pain (-0.69cm on a 10cm visual analogue scale) and improved physical functioning (2.04 of 100 points). However, these improvements were marginal and did not meet the minimally important differences (i.e. the smallest amount of improvement that a patient would recognise as being significant).
While the evidence for long-term efficacy is limited, there is substantial evidence to demonstrate a dose-dependent risk of serious harms. These harms may include overdose, abuse, and an increased risk of fractures, myocardial infarction, cognitive impairment, and problems affecting the endocrine and digestive systems. These opioid-related risks translate into an average of almost 150 hospitalisations and three deaths in Australia each day.
In an effort to reduce the harms associated with prescription opioids, the Therapeutic Goods Administration (TGA) has announced the following measures:
- Immediate-release opioids will be available in smaller size packets. This will facilitate the dispensing of appropriate quantities to patients and avoid concerns related to the storage of leftover opioids. This change is particularly important when opioids are prescribed for the treatment of minor, self-limiting pain states. OxyNorm® is already available in packets of 10 capsules in addition to the larger packs containing 20 and 60 capsules;
- The product information (PI) documents for all prescription opioids will be updated to include a boxed warning and class statements regarding their potential for harmful and hazardous use;
- Consumer medicines information (CMI) leaflets will be updated for all prescription opioids to include prominent and consistent safety information and warnings for consumers;
- The indications listed in the PI will reinforce the requirement to reserve opioids for when other analgesics have proven ineffective;
- The indication for fentanyl patches will be updated to state that they should only be used to treat patients with cancer, in palliative care, or under exceptional circumstances. Fentanyl is a high potency opioid, and the misuse of fentanyl patches has been identified as a potential emerging issue in Australia. An increasing number of fentanyl-associated deaths have been reported, most of which involved the extraction and injection of the contents of fentanyl patches; and
- An educational campaign will run to communicate these changes to consumers and healthcare professionals.
Smaller pack sizes and updated fentanyl indications are expected in the first half of 2020; the other changes will be phased in. These measures add to other recent changes such as the upscheduling of codeine and the progression of real-time prescription monitoring.
All of these actions are intended to support the objectives of the National Strategic Action Plan for Pain Management. As the overarching goal of this plan is to improve the quality of life for people living with pain, regulatory changes are not intended to limit appropriate access to opioids for patients in need. Instead, the national action plan advocates for the safe and effective use of pain medication in conjunction with non-pharmacological measures where appropriate.
- Analgesic Expert Group. Therapeutic Guidelines: Analgesic. Version 6. Melbourne: Therapeutic Guidelines; 2019.
- Busse JW, Wang L, Kamaleldin M, Craigie S, Riva JJ, Montoya L, et al. Opioids for chronic noncancer pain: a systematic review and meta-analysis. JAMA. 2018; 320(23): 2448-60.
- Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health pathways to prevention workshop. Ann Intern Med. 2015; 162(4): 276-86.
- Department of Health. National Strategic Action Plan for Pain Management. Canberra: Australian Government; 2019.
- Department of Health. Prescription opioids hub: upcoming changes to reduce harm. Woden: Therapeutic Goods Administration; 2019.
- National Coronial Information System. NCIS Fact Sheet: Deaths related to fentanyl misuse. Southbank: NCIS; 2013.