Therapeutic Goods Administration (TGA) announces that pharmaceutical opioids are now responsible for far more deaths and poisoning hospitalisations in Australia than illegal opioids such as heroin.
To help reduce the harm, TGA conducted a public consultation on prescription opioids in 2018. Throughout the process, it has been recognised that opioids play an important role in providing pain relief for many people and there has been a focus on ensuring appropriate and safe access is maintained. Several reviews and activities arose from the consultation. As a result:
- Smaller pack sizes will be available for immediate-release prescription opioid products.
- TGA will require that sponsors include 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.
- TGA will work with sponsors to ensure that safety information, including the relevant warnings, is prominently displayed in the Consumer Medicines Information (CMI) to ensure consistency of language and information across all classes of prescription opioids.
- The indications in the PI documents for prescription opioids will reinforce that opioids should only be used when other analgesics have proven not to be effective.
- Fentanyl is one of the strongest opioids available in Australia. In recognition of the increased potential for harmful and hazardous use, the indication for fentanyl patches will be updated to state they should only be prescribed to treat pain in patients with cancer, patients in palliative care and those with exceptional circumstances.
- TGA will be communicating the changes to both prescribers and consumers using a range of channels to ensure health professionals follow best prescribing practice and consumers are fully informed how best to use opioids. TGA has already begun to encourage consumers to return unwanted opioids to pharmacies for destruction by distributing prescription covers with relevant messaging to every pharmacy in Australia as well as via various social media activities.
The products affected are prescription opioids such as fentanyl, codeine, hydromorphone, oxycodone, morphine, tramadol, tapentadol, buprenorphine and methadone.
The measures have been carefully considered to ensure that they support and maintain the safe and clinically appropriate use of opioids without restricting prescribers from accessing them for their patients when needed. These actions are also similar to activities that have been undertaken in other countries, for example the United States and Canada.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/prescription-opioids
In Hong Kong, there are registered pharmaceutical products containing fentanyl (13 products), codeine (358 products), oxycodone (23 products), morphine (22 products), tramadol (50 products), tapentadol (8 products), buprenorphine (8 products) and methadone (4 products). There is no registered pharmaceutical product containing hydromorphone. So far, the Department of Health (DH) has received adverse drug reaction related to codeine (4 cases), oxycodone (2 cases), morphine (8 cases, of which one case is related to drug abuse), tramadol (2 cases) and methadone (4 cases).
News related to the safe and appropriate use of opioid analgesics was previously issued by the US Food and Drug Administration and Health Canada, and was posted on the Drug Office website on 11 Sep 2013 and 19 Aug 2014 respectively. Letters to inform local healthcare professionals were issued by the DH on 11 Sep 2013. The Registration Committee of the Pharmacy and Poisons Board discussed the matter in Feb 2015. Currently, pharmaceutical products which are controlled-release, extended-release or long-acting opioid analgesics (containing hydromorphone, morphine, oxycodone, tapentadol, fentanyl, buprenorphine and methadone) should include safety information about the risks of addiction, abuse, misuse, overdose and death, and limitations of use in patients with severe pain for which alternative treatment options are inadequate. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, Aug 23, 2019
Issued at HKT 16:00
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