Australia reschedules naloxone for opioid overdose

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Australia reschedules naloxone for opioid overdose

10 March 2016
Simon Lenton

On 24 November 2015, the Therapeutic Goods Administration (TGA) announced its final decision to place “naloxone when used for the treatment of opioid overdose” on Schedule 3, thereby allowing over-the-counter (OTC) purchase. This measure came into effect on 1 February 2016, making Australia the second country, after Italy (in 1995), to have naloxone formally available OTC.

With much recent media focus on problems due to crystalline methamphetamine use in Australia, few may be aware that deaths from opioid overdose have been increasing over recent years.Following the “heroin drought” of late 2000, accidental deaths from heroin and other opioids among Australians aged 15–54 years dropped from 1116 deaths in 1999 (10.19 deaths per 100 000 population) to 386 deaths in 2001 (3.46 deaths per 100 000 population). However, opioid-related deaths have been rising steadily since 2007 — the most recent confirmed data indicate that 617 Australians aged 15–54 years died in 2011 (4.95 deaths per 100 000 population). Estimates for 2012 and 2013 suggest that this trend continues.

Take-home naloxone (THN) programs are designed to help manage opioid overdose events in the pre-hospital setting.These programs involve training potential overdose witnesses (typically opioid users, and their friends and families) in overdose response (including naloxone administration) and then prescribing and distributing naloxone to potential overdose victims for later use in an overdose situation. Training typically includes education on risk factors for opioid overdose, signs of opioid overdose, basic life support and overdose response, including resuscitation techniques, calling for an ambulance, administration of naloxone, and post-naloxone management. Training addresses the possibility of rebound opioid toxicity due to the relatively short half-life of naloxone (mean, 60 min; range, 30–80 min)compared with many opioids and the need to monitor the person and administer another dose of naloxone if required. However, the evidence indicates that rebound toxicity is rare. To date, naloxone kits provided to trainees in Australian THN programs have typically comprised between 2 and 5 minijets of naloxone 400 μg/mL plus intramuscular needles, swabs, gloves and instructional materials.

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