ATODA understands that Canberrans (including those in detention) continue to be referred to (or supported to access) interstate services that provide sustained release naltrexone (e.g. implants) for the treatment of opioid dependence.
ATODA wishes to re-iterate that sustained release naltrexone products are not registered with the Therapeutic Goods Administration
ATODA has recently updated its advice to members and stakeholders that sustained release naltrexone (e.g. implants) are not recommended for treating opioid dependence.
According to the National Health and Medical Research Council (NHMRC):
“Evidence is currently at an early stage and as such, naltrexone implants remain an experimental product and should only be used within a research setting. Until the relevant data are available and validated, the efficacy of the treatment, alone or in comparison to best practice, cannot be determined. NHMRC’s position on naltrexone implants is that further research on adverse effects is required before a statement on safety can be confidently made.”
The Australian National Council on Drugs (ANCD) is an expert advisory council to the Australian Government and appointed by the Prime Minister. Its members include some of the country’s leading experts in their respective fields related to alcohol, tobacco and other drugs. The ANCD recently released a position statement on Naltrexone Sustained Release Preparations (Injectable & Implants). Their position statement agrees with the conclusion of the NHMRC review that further clinical trials are necessary to ensure the efficacy and safety of naltrexone.
The findings from the NSW State Coroner regarding the deaths of three people have continued to raise concerns about the use of naltrexone. The Coroner’s recommendations include strongly endorsing the statements and recommendations of the ANCD that naltrexone is not recommended for the treatment of opioid dependence.
ATODA calls on its members and stakeholders to raise awareness of this advice with consumers, families, support people and the broader community; the alcohol, tobacco and other drug sector; and allied sectors (including mental health, legal services, the courts and corrective services) to ensure that Canberrans are not referred for treatment for opioid dependence with sustained release naltrexone until there is sufficient evidence to ensure its safety and efficacy.
National Health and Medical Research Council (2011). Naltrexone Implant Treatment for Opioid Dependence: Literature Review – 2010. Canberra: NHMRC.
Lobmaier P, Kornor H, Kunoe N, Bjørndal A. Cochrane: Sustained-Release Naltrexone for Opioid Dependence.
Gowing L, Ali R, Dunlop A, Farrell M, Lintzeris N (2014) National Guidelines for medication-assisted treatment of opioid dependence. Canberra: Commonwealth of Australia.
Note: the above national guidelines are the updated version of these guidelines these are the Intergovernmental Committee on Drugs. (2007) National Phamacotherapy Policy for People Dependent on Opioids. Canberra: Australian Government.
ACT Health. (2010) ACT Opioid Maintenance Treatment Guidelines. Canberra: ACT Government.
Note: The ACT guidelines are currently being reviewed, for further information contact the Opioid Treatment Advisory Committee Secretariat through ACT Health on firstname.lastname@example.org
Australian National Council on Drugs
Their position statement agrees with the conclusion of the NHMRC review that further clinical trials are necessary to ensure the efficacy and safety of naltrexone.
Australian National Council on Drugs (2012). Naltrexone Sustained Release Preparation (Injectable & Implants). ANCD Position Statement – March 2012. Canberra: ANCD.
The Royal Australasian College of Physicians (RACP) recognises that long-acting naltrexone products may ultimately prove to be a safe and effective treatment approach for opioid dependence. Accordingly, it is appropriate to support the development of registered products that safely and effectively deliver this treatment. However, until suitable product(s) have undergone normal regulatory assessment procedures and are licensed with the Therapeutics Goods Administration (TGA), unregistered products should not be used on a routine basis and a range of safeguards are required to protect patients, their families, and health professionals.
The Royal Australian College of Physicians (2013). The Use of Sustained Release Formulations of Naltrexone in Opioid Dependence Position Statement. Sydney: RACP.
In 2012, ATODA developed a position, consistent with the NHMRC and ANDC, against the use of sustained release naltrexone for the treatment of opioid dependence in 2012. ATODA has updated this position to reflect further developments in the field. The most recent
Sustained release naltrexone (e.g. implants) is not recommended for treating opioid dependence in Australia (2012, Updated October 2014)
Following requests from ATODA, we are pleased that the Opioid Treatment Advisory Committee developed a formal statement in 2013 (see below).
ACT Opioid Treatment Advisory Committee
The Opioid Treatment Advisory Committee, as the advisory body on matters relating to opioid maintenance treatment in the ACT, supports the Royal Australasian College of Physicians (RACP) Position Statement, developed by RACP’s Australasian Chapter of Addiction Medicine.
Opioid Treatment Advisory Committee (OTAC)
OTAC, as the advisory body on matters relating to opioid maintenance treatment in the ACT, supports the Royal Australasian College of Physicians (RACP) Position Statement, developed by RACP’s Australasian Chapter of Addiction Medicine (attached).
As no long-acting naltrexone product is registered currently for use in Australia by the Therapeutic Goods Association (TGA), until one or more suitable products have undergone normal regulatory assessment and are registered by the TGA, they should not be used on a routine basis.
It is essential that individuals who are opioid dependant and their families are informed regarding the lack of sound scientific evidence on the efficacy and safety of naltrexone sustained release implants. Their use may put the individual at risk of harm or death.
OTAC looks forward to receiving news on the research developments in this area.
The Australian Injecting & Illicit Drug Users League (AIVL) has welcomed a recent coronial inquest into the deaths of three people in NSW associated with naltrexone implants and the media coverage earlier this week and today that has followed the report’s release. Unfortunately however, we also believe the recommendations of the inquiry do not go anywhere near far enough in addressing the seriousness of the apparent medical negligence issues and fundamental human rights abuses at the heart of these 3 cases.
Injecting drug users are a marginalised group in Australia. It is particularly important that medical research and the provision of health services to marginalised groups is handled with even greater care than usual. Cutting corners in research and clinical treatment undermines the processes adopted over the years to minimise the chances of errors of judgment, both in research and in treatment.
If you are thinking about having naltrexone treatment (including a naltrexone implant), make sure that you do your homework first. Find out all you can about the benefits and risks. Get information from more than one source, and certainly from more than just the clinic providing the implant.
Warning over addicts’ implant (Canberra Times, 06 May 2013)
Drug addiction treatment divides opinions (ABC’s 7:30 Report, 23 October 2012)
Detox clinic reignites implant debate (The Brisbane Times, 20 October 2012)
Patient deaths don’t deter detox clinic (Australian Doctor, 15 October 2012)
Nile wants funding for heroin ‘cure’ (Sydney Morning Herald, 19 October 2012)
A dangerous method with tragic consequences (The Canberra Times, 16 October 2012)
Coroner slams clinic’s treatment of addicts (ABC News, 28 September 2012)
Coroner blames poor treatment for detox deaths (ABC’s Lateline, 27 September 2012)
Alcohol Tobacco and Other Drug Association ACT
(02) 6249 6358
Last updated 23 October 2014