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Health Canada Statement on Change in Federal Prescription Status of Naloxone

By Calliope, Jan 15, 2016 | Updated: Jan 16, 2016 | |
  1. Calliope
    Health Canada today proposed a change to make naloxone more widely available to Canadians in support of efforts to address the growing number of opioid overdoses. After taking the unprecedented step of initiating a review of the drug’s prescription status, Health Canada has put forward an amendment to the prescription drug list to allow non-prescription use of naloxone specifically for emergency use for opioid overdose outside hospital settings. The product labelling would be revised and training would be required for those potentially administering the drug. A consultation seeking views on this proposal has been launched.

    Naloxone is a drug administered by injection that reverses the effects of opioid medications and can be used to temporarily counteract opioid overdoses. Some provinces have already expanded the availability of naloxone through community-based take-home programs, and others have undertaken regulatory changes to allow use by first responders.

    Health Canada’s goal in considering whether to change the prescription status of any drug is to determine whether it can be used safely outside the direct supervision of a health-care practitioner. Working closely with the provinces and territories the Department requested, collected and assessed: the health and safety data, such as the record of adverse reactions associated with naloxone use; the need for immediate follow-up treatment (since the effects of naloxone are temporary); and the requirements for administering the drug.

    Health Canada undertakes a public consultation whenever a change is proposed to the prescription status of any drug. Canadians are encouraged to provide comments on the proposal until March 19, 2016. If the change in status continues to be supported by the evidence and input received during the consultation, the change will be finalized. Health Canada 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.

    Health Canada remains concerned about the growing number of opioid overdoses and deaths occurring across Canada, and will continue working with the provinces and territories and other stakeholders to address this important issue.


    And in keeping with the Canadian way of doing these things...encore une fois, en français:

    Déclaration de Santé Canada sur un changement du statut fédéral de vente sur ordonnance de la naloxone
    Santé Canada a proposé aujourd'hui un changement pour augmenter l'accessibilité de la naloxone aux Canadiens, pour soutenir des efforts visant à traiter le nombre croissant d'overdoses aux opioïdes. Après avoir pris la mesure sans précédent d'entreprendre un examen du statut de vente sur ordonnance du médicament, Santé Canada a proposé une modification de la Liste des drogues sur ordonnance afin de permettre l'utilisation de la naloxone sans prescription, en particulier pour une utilisation d'urgence en cas d'overdose aux opioïdes à l'extérieur des hôpitaux. L'étiquetage de produits sera revu et les personnes qui pourraient administrer la drogue auront besoin d'une formation. Une consultation pour obtenir des avis sur cette proposition a été lancée.

    La naloxone est une drogue administrée par injection qui arrête les effets de médicaments opioïdes et qui peut être utilisée pour contrer temporairement des overdoses d'opioïdes. Certaines provinces ont déjà augmenté la disponibilité de la naloxone par des programmes communautaires de produits à emporter à domicile et d'autres ont entrepris des modifications législatives pour qu'elle puisse être utilisée par les premiers intervenants.

    L'objectif de Santé Canada lorsqu'elle étudie si le statut de vente sur ordonnance d'une drogue doit être modifié est de déterminer si elle peut être sécuritairement utilisée en dehors de la supervision directe d'un professionnel de la santé. En travaillant étroitement avec les provinces et les territoires, le Ministère a demandé, recueilli et évalué : les données de santé et sécurité, dont les réactions indésirables notées, associées à l'utilisation de naloxone; le besoin de traitement de suivi immédiat (puisque les effets du naloxone sont temporaires); et les exigences pour administrer la drogue.

    Santé Canada entreprend une consultation publique lorsqu'un changement est proposé au statut de vente sur ordonnance de n'importe quelle drogue. Nous encourageons les Canadiens à fournir des commentaires sur la proposition jusqu'au 19 mars 2016. Si le changement de statut est toujours soutenu par la preuve et les avis reçus durant la consultation, le changement sera finalisé. Santé Canada a l'intention de renoncer à la période de mise en œuvre habituelle de six mois qui suit de telles décisions pour que le changement de statut puisse être effectué dès que possible.

    Santé Canada continue d'être préoccupé par le nombre croissant d'overdoses et de décès causés par des opioïdes partout au Canada et continuera de travailler avec les provinces et les territoires et les autres intervenants afin de traiter cette question importante.

    Given the legitimacy of the following opinion piece only 4 days ago this announcement is extremely welcome!!

    No excuse for Canadian government’s slow response to fentanyl crisis
    Special to The Globe and Mail
    Published Sunday, Jan. 10, 2016

    When gang violence erupted in British Columbia in 2009, the federal government acted at light speed to implement measures to contain the violence. That rapid response stands in stark contrast to the feds’ lethargy in dealing with the very things the gangs were fighting over: drugs.

    Drug overdoses are nothing new, of course, especially in Western Canada. But at the onset of the gang war, something new did appear: fentanyl, a synthetic opioid about 100 times more potent than morphine.

    According to the Canadian Community Epidemiology Network on Drug Use, fentanyl was detected in more than 1,000 drug-poisoning deaths in Canada from 2009 to 2014. Furthermore, fentanyl-detected deaths increased by nearly 700 per cent from 2012 to 2014 in B.C., and by more than 2,000 per cent from 2011 to 2014 in Alberta. The trend continued unabated last year, with record numbers of fentanyl-detected deaths in both provinces.

    Clearly this is a crisis situation. And when you’re faced with such a situation, you have to act fast, particularly when you have the means to avert the crisis.

    We have the means. It’s called naloxone, a drug that blocks opioids in the brain, thereby preventing or reversing an overdose. Naloxone has been used in Canadian emergency rooms for more than 40 years, and many provinces have recently started providing Take Home Naloxone kits to people who use drugs, along with training in recognizing and reversing overdoses.

    Because of federal law, however, some people don’t have the means. Since naloxone is provided to drug users by prescription, friends and family members – the people in the best position to administer the drug – are unable to obtain it. Even firefighters, often the first responders at the scene of an emergency, don’t have access to naloxone.

    In contrast, over-the-counter naloxone is available in many jurisdictions, including many in the United States, the country often vilified for its unenlightened approach to illicit drugs. Given this, and given the abundant evidence of the life-saving effectiveness of the drug – it’s credited with saving tens of thousands of lives in the United States – you would think that the Canadian government would approve over-the-counter naloxone post-haste.

    But you would be wrong. When fentanyl overdoses made headlines last summer, Health Canada announced that it was reviewing the status of the drug. Six months later, the review, and overdose deaths, continue. During those six months, fentanyl probably claimed the lives of more people than B.C.’s entire gang war.

    In a self-congratulatory e-mail, Health Canada states that it “is very concerned about the growing number of fentanyl overdoses and deaths” and notes that it took “the unprecedented step of initiating a review of the prescription status of naloxone.” Yet it is unable to indicate when the review will be completed, saying only that a decision is expected early this year.

    That’s not good enough. While the change of governments no doubt slowed the process, the failure to provide sufficient access to naloxone amounts to nothing less than withholding proven, lifesaving treatment. As I wrote five months ago, we need better access to naloxone, and we need it now.

    Now, with that said, naloxone will not prevent all drug overdoses. While an essential element of any rational and humane drug strategy, it is, if you will, a quick fix for a bad fix. Many other measures, both short- and long-term, must accompany increased access to naloxone.

    In the short term, enhanced surveillance would allow public-health authorities to quickly identify and communicate to users the presence of contaminated drugs on the street. And drug users, their friends and families would benefit from improved training in preventing, recognizing and treating overdoses.

    Many of the provinces have been working on these measures, and physician-epidemiologist Jane Buxton, harm reduction lead at the B.C. Centre for Disease Control, notes that B.C.’s Drug Overdose and Alert Partnership will be releasing a strategy to address these issues in the next week or so.

    In the long term, the provinces ought to consider opening supervised injection facilities, like Vancouver’s Insite, which provide a space for users to inject drugs under the supervision of health-care professionals. Numerous studies have confirmed that Insite has helped to prevent overdose deaths while improving the physical, mental and social health of its clients. The facility also helps to introduce many disenfranchised drug users to the health-care system, some of whom proceed to rehab (Onsite) to cease using drugs.

    Unfortunately, the previous federal government led by Stephen Harper, with its medieval attitude toward drugs, erected numerous barriers to the establishment of supervised injection sites through the Orwellian Respect for Communities Act. But Prime Minister Justin Trudeau, who has expressed support for injection sites, can easily dismantle those barriers by repealing the act.

    Finally, increased access to opioid-substitution therapy would allow opioid users across Canada to obtain drugs from a doctor rather than a dealer, thereby avoiding potentially contaminated street drugs. Clinical trials around the world, including in Vancouver, have found that this treatment also improves patients’ physical, mental and social health.

    Such measures are, of course, not without controversy. But if we are ever to divorce drugs from death, we must not be afraid to implement them. And we must implement them now.



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