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A Drug that Reverses Opioid Overdoses Is About to Be Sold Over-the-Counter in Australia

Easier access to naloxone could lead to a sizable decrease in opioid-related deaths.

by Paul Gregoire
Oct 16 2015, 6:20pm

Opioid overdoses occur when the receptors in the brain become overwhelmed by the drug. Naloxone knocks opioids off these receptors, allowing normal functions—such as breathing—to resume. Image courtesy of the Canberra Alliance of Harm Minimisation and Advocacy

This article originally appeared on VICE Australia

Lorraine is a homeless woman living in Sydney's Redfern neighborhood who's injected opioids for the last 15 years. On Tuesday night, she was with a group of friends under a bridge. They'd taken some coke and were about to shoot up some gear. She told a male friend, who had just gotten out of jail, to be careful and only take half. A few minutes later, she heard another woman calling out that something was wrong.

"He wouldn't blink and I just started screaming, 'He's dead, he's dead.' Because I didn't see him breathing," Lorraine recounted. "I didn't have a phone, so I said, 'Someone call an ambulance.'"

Another woman, who'd been trained in CPR, began to try and resuscitate him. It took between 20 minutes and half an hour for the ambulance to turn up, but fortunately the man's life was saved.

Read on Motherboard: Meet the Fake Heroin Behind the Next Overdose Epidemic

In the midst of the commotion and arguments about how to keep his heart beating, another man who was there named Terry Terry turned to Lorraine and said, "Have you got any naloxone?"

Naloxone is an opioid antagonist, meaning it counters the effects of opioids like heroin and oxycodone. A user overdoses when the receptors in the brain become overwhelmed by the drugs. Naloxone knocks opioids off these receptors, allowing normal functions—such as breathing—to resume.

Lorraine didn't have any of the lifesaving drug on her that night, nor did anyone else who was there. But from early next year, when it becomes readily available at Australian pharmacies, it will be more likely that someone does. (Naloxone is currently available over-the-counter in a number of US states.)

On October 1, the Therapeutic Goods Administration (TGA) announced its interim decision to down-schedule naloxone in single-use pre-filled syringes. It will go from being a Schedule 4 prescription-only substance to Schedule 3, making it an over-the-counter (OTC) medicine. The TGA's final decision will be announced in late November, but according to Angelo Pricolo, the pharmacist who submitted the application to reschedule the drug, the interim decision is a "virtual rubber stamp," which means naloxone will be available without a script as of February 1 next year.

The latest figures from the National Drug and Alcohol Research Centre outline that in 2011 there were 683 accidental opioid overdoses in Australia, with an additional 162 intentional cases and 114 undetermined.

Angelo saw the need to make naloxone easier to access. In his 25 years of practice, the Brunswick pharmacist—who currently runs a 100 client opioid replacement treatment program—has never filled a prescription for naloxone. "A concerned third party can now go to the pharmacy and buy naloxone and that's the big difference," explained Pricolo.

Of the 96 submissions made in support of OTC naloxone, 57 of them were submitted via the Sydney Medically Supervised Injecting Centre (MSIC). Dr. Marianne Jauncey, medical director of the center, told VICE that it was important to provide their clients with information about the decision and the capacity to make submissions. "It was trying to give a voice to people who are most directly affected," she said. "They may be receiving the dose or they might be giving the dose to a friend or loved one."

Marianne stressed naloxone has no potential for abuse and it should have a dual listing, making it available over-the-counter and via prescription at a subsidized price. She also says that people who obtain it will need access to training in how to recognize an overdose and when to use it.

RELATED: How Not to Die of an Overdose

James was watching the third State of Origin game at home in Sydney with a friend last year. They'd taken some prescription painkillers, which they'd mixed with benzodiazepines. It was after his friend shot up some heroin that he noticed something was off. "She was slumped over," he recalled. "When I pulled her back, her face was all blue."

But luckily the 31-year-old, who's been using himself for 17 years, has been prescribed and trained in the use of naloxone at the MSIC. After administering a second dose, his friend began breathing. "It was the fact that I could access naloxone that saved my friend's life."

A problem with the current system in Australia is that a doctor prescribes naloxone to a drug user, who is unlikely to be able to administer it to him or herself after overdosing. In Italy, naloxone has been available over-the-counter since 1995, making it available for peer administration, with no adverse effects. A 2010 report outlined that since 1996 in the United States, programs had distributed 53,032 naloxone kits and 10,171 overdose reversals had occurred. A 2014 World Health Organization report recommended that countries expand naloxone accessibility.

"It's been very successful. We've had 58 overdose reversals that we know of."—Dave Baxter, coordinator of the Canberra Alliance of Harm Minimisation and Advocacy

Of late, Australia's first take-home naloxone program, trialled in the Australian Capital Territory, has made some breakthroughs. Along with naloxone's potential to save lives and minimal side effects, the TGA listed the results of this program as one of the reasons for making their decision.

Established in April 2012 and run by the Canberra Alliance of Harm Minimisation and Advocacy, the trial has seen the distribution of naloxone to 200 participants, along with training in the use of the drug and overdose management. "It's been very successful. We've had 58 overdose reversals that we know of," said Dave Baxter, coordinator of the program. "It's quite likely there's been more that haven't been reported."

The Centre for Research Excellence into Injecting Drug Use was another institution that made a submission in support of OTC naloxone. Professor Paul Dietze, one of the chief investigators at the center, said the decision to make naloxone a Schedule 3 substance is an important one in the global context. "There isn't enough training out in the community about how to access and use it," Dietze explained. "Hopefully the down-scheduling will change that situation."

Yesterday, Lorraine was back at the MSIC in Kings Cross, still a little shaken. She was given a free naloxone kit and undertook the training on how to administer it. "That would have made a whole hell of a difference, if we had it then and there," she said, referring to the events of the night before. "He would have been sitting up two minutes into it."

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