naltrexone implants alert
last updated 5 September 2011
Practitioners who prescribe, insert or are otherwise involved in managing patients with naltrexone implants should be aware of the recently advised National Health and Medical Research Council (NHMRC) position* that considers these to remain an experimental product and should only be used within a research setting. The NHMRC position is that further research on adverse effects is required before a statement on safety can be confidently made. The position taken by the NHMRC is likely to make any claim arising from an adverse event involving a naltarexone implant administered outside a research setting difficult to defend.
As a result MIPS announced on its website on 9 June 2011 that:
Until a final position has been reached by the NHMRC regarding product safety, MIPS gives all members 14 days notice pursuant to Section 6.2 of the MIPS Members Insurance Policy that they must stop providing or carrying out any treatment, procedures or practices relating to naltrexone implants unless undertaken completely within an accredited research setting.
The NHRMC states that naltrexone is available in oral, depot injection or implant preparations, however only the oral form of naltrexone has been approved by the TGA.
MIPS now extends the above notice to include depot injections of naltrexone.
* see NHMRC website “Naltrexone implant treatment for opioid dependence – literature review”
www.nhmrc.gov.au/media/notices/2011/naltrexone-implant-treatment-opioid-dependence-literature-review
MIPS is continuing to monitor the situation and will keep members apprised of developments. Any specific queries from members can be directed to the MIPS Membership Acceptance, Advisory and Assessment Committee via Member Services.