Notice to Interested Parties - Mandatory Notification of Drug Shortages
Drug shortages are a complex and pressing global issue with serious implications for the health and well-being of Canadians. Sudden or prolonged disruptions in the availability of a product can have serious and/or life-threatening consequences for patients. It is only through the availability of timely, comprehensive, and reliable information that stakeholders across the healthcare system can make the decisions necessary to help mitigate and prevent the impacts of shortages. This is why the federal government called upon drug manufacturers and importers to voluntarily provide public notification of all drug shortages and discontinuances on the industry funded and administered Canadian Drug Shortage Website (www.drugshortages.ca).
From its inception, the goal of Canadian Drug Shortage Website (www.drugshortages.ca) was to establish a one-stop public information site providing Canadians, and those who care for them, with necessary information on anticipated or actual drug shortages and discontinuances. To determine whether this approach was providing Canadians with the information they require, Health Canada conducted extensive consultations with Canadians, patients, key stakeholders, and international counterparts, from May to July 2014.
While improvements have been made to Canadian Drug Shortage Website (www.drugshortages.ca) over the past two years, Canadian patients, healthcare providers and other key stakeholders stated clearly that the current, voluntary approach to drug shortage notification is not providing the timely, comprehensive and reliable information they require to mitigate and prevent the potentially serious and/or life-threatening consequences of shortages. In light of this, the majority of respondents indicated that mandatory drug shortage notification overseen by Health Canada was required.
Health Canada is therefore providing this notice to interested parties, signaling its intention to regulate the notification of drug shortages, to provide healthcare providers with useful information with which to make informed decisions, as proposed here:
- Industry will be obligated to report discontinuations to Health Canada in advance of discontinuing the product;
- For planned or anticipated shortages, advance notification will be required within a reasonable timeframe;
- For unforeseen shortages, regulations will require notification within a reasonable timeframe;
- Shortage notification requirements will apply to human drugs and will not apply to veterinary drugs, the majority of non-prescription drugs, consumer health or personal care products, cosmetics, toiletries or disinfectants.
Going forward, Canadians will be invited to comment on this regulatory proposal through a future Canada Gazette process.
Furthermore, as an interim measure to ensure greater industry transparency and accountability while regulations are advanced, Health Canada has launched a Public Notification Register for Drug Shortages, available on Health Canada's website. The Public Notification Register provides a list of human pharmaceutical or biologic drug suppliers who have committed to voluntary public notification on Canadian Drug Shortage Website (www.drugshortages.ca). Health Canada will also publicly post letters to those drug suppliers who fail to provide notification of shortages under this interim measure.
Health Canada contact:
Director, Strategic Horizontal Policy Division and Office of Paediatric Initiatives
Health Products and Food Branch
Health Canada / Government of Canada
250 Lanark Ave. K1A0K9
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