OTCs in Action Ep 55: Overdoses spur fast-track naloxone switch

OTCinActionheader

Peter McKnight, of the School of Criminology at Simon Fraser University, wrote about the rising rates of fentanyl overdoses in the 13 August 2015 Toronto Globe & Mail, and observed:

So, 45 years after US president Richard Nixon first declared what has become a worldwide war on drugs, opiates remain as easy as ever obtain.

But what if opiates aren’t your drug of choice? What if you’re looking instead for a drug that can reverse the deadly effects of opiates? Well – and here’s more irony – that drug is a lot harder to get. It’s called naloxone, a drug that blocks the effects of opioids in the brain, thereby reversing an overdose and preventing the loss of consciousness and cessation of breathing that often follow. A non-addictive, non-intoxicating, low-risk drug, naloxone has been used in Canadian emergency rooms for more than 40 years.

The trouble, of course, is that most people don’t shoot up in hospitals. People commonly use drugs – and overdose – at home, in a washroom or in an alleyway. And if we are to reduce the risk of death or brain damage, naloxone must be available wherever and whenever an overdose occurs.”

This week OTCs are in Action in Canada, where Health Canada announced its intention to make naloxone available for emergency use for opioid overdose without a prescription so that families can have emergency treatment kits at home and readily available, according to Nicholas Hall’s OTC.NewDirections. The agency is reviewing safety and efficacy data during a consultation period ending on 19th March, after which it intends to waive the usual six-month implementation period that follows such decisions so that the change in status can occur as quickly as possible.

To review a prior OTCs in Action on naloxone availability, click here:

nicholashallcompany.wordpress.com/2015/08/03/otcs-in-action-episode-36-naloxone-to-the-rescue/

To learn more about Nicholas Hall’s OTC.NewDirections, click here:

http://www.nicholashall.com/otc-newdirections

To read Mr. McKnight’s original editorial, click here:

http://www.theglobeandmail.com/opinion/why-is-an-opiate-antidoteharder-to-obtain-than-the-drug/article25959264/

OTCs in Action Episode 36: Naloxone to the rescue

OTCinActionheaderAccording to the World Health Organization, around 69,000 people die from opioid overdose each year. Timely administration of the Rx drug, naloxone, can counteract the effects of overdose – although tragically, most overdoses occur far from a medical setting. Last week, Health Canada announced that it is working with local governments in provinces and territories to assess the rescue drug’s Rx-to-OTC switch, while Adapt Pharma Limited submitted a New Drug Application to the US FDA for Narcan (naloxone) Nasal Spray. An FDA workshop earlier this summer focused on expanding access to naloxone and the injectable delivery of the drug – was seen as a barrier to switch.

site of overdose

Source: CDC, Adapt Pharma, LLC

The overdose crisis and the generic availability of naloxone is creating the bottom-up model of switch. Traditional Rx-to-OTC switches are manufacturer-driven, with clinical and actual use studies conducted by drug owners and submitted to regulatory bodies. In the case of naloxone, expanded access is already being expedited at local government level in the US and Canada. In the beginning of 2015, California joined New Mexico, Washington, New York, Rhode Island, and Vermont in making naloxone available from pharmacists without a prescription. In many states / provinces and cities in the US and Canada, programmes equipping emergency first responders, including police officers, with naloxone, have been highly successful. Addiction clinics also provide opioid users with take-home naloxone kits and training for their families and friends in how to inject it in case of an opioid overdose. Data collected at local level should provide Health Canada and the FDA with compelling evidence in favour of an Rx-to-OTC switch of naloxone.