Naloxone to be Made Available Over the Counter in Australia

A recent ruling in Australia could result in naloxone, the life-saving drug that reverses opioid overdoses, being available without prescription from February 2016.

The interim ruling, made by the Therapeutic Goods Administration (TGA), moves naloxone from Schedule 4 to Schedule 3, removing physical and legal barriers for those most in need of access to the life-saving medication, while also making it possible for families and friends of drug users to obtain naloxone to keep on hand. One of the reasons provided for the decision is the following:

"Benefits of rescheduling naloxone for reversal of opioid overdose to Schedule 3 include that products would be supplied labelled with full and clear instructions for use, understandable by consumers. People who need naloxone would be able to obtain it more easily, which is likely to decrease the proportion of (deliberate or accidental, usually illicitly obtained) opioid overdoses that result in death. Increased accessibility would also potentially reduce morbidity due to opioid overdose, such as hypoxic brain damage."

As it currently stands, those who seek access to naloxone need to visit a doctor and admit to using opioids in order to receive a prescription.

When it comes to opioids, heroin has historically been the most misused in Australia, though there has been concern about an uptick in the rate of overdoses related to prescription painkillers in recent years

In 2011 the National Drug and Alcohol Research Centre (NDARC) reported 683 opioid-related deaths and the rate of fatal opioid overdose in Australia to be 30.5 deaths per million, highlighting the need for unrestricted access to naloxone. In 2012, the amount of drug overdose deaths outnumbered the amount of deaths from road accidents (1,427 and 1,338 respectively). Opioids are estimated to account for around 650 overdose deaths on an annual basis.

Local initiatives to expand naloxone provision -- led predominantly by service providers -- have been undertaken in recent years, aimed at getting naloxone directly into the hands of drug users in Canberra, Sydney and Adelaide. Kits containing a syringe, gloves, and a disposal container were distributed and training sessions given on proper use. Areas that haven't benefited from such initiatives have suffered; for example, in the state of Victoria where 384 overdose deaths were recorded in 2014, with almost 50 percent involving opioid prescription drugs.

Pharmacist Angelo Pricolo who submitted the proposal to the TGA to make naloxone available over the counter decried the current prescription-based system in an interview with the Australian Journal of Pharmacy, saying, "In 25 years as a practicing pharmacist I have never dispensed a naloxone minijet -- and that means I’ve never received a prescription for it. The mechanism was there, but it just wasn’t happening in reality."

Pricolo added, "The realisation is growing that naloxone should be made more available, and what better way to do that than take the already-established network of pharmacies in Australia – with over 5,000 possibilities for it to be sold or made available?”