Harper Government Moves to Implement Mandatory Drug Shortage Reporting

Early, comprehensive Supply Information Will Help Healthcare Providers Coordinate Treatment Plans

OTTAWA, June 23, 2015 /CNW/ - The Honourable Minister of Health, Rona Ambrose, announced today that the Government is taking the next step towards implementing mandatory reporting of drug shortages by companies. The amendments being proposed to the Food and Drugs Regulations would require manufacturers to:

• provide six-months advance notice of anticipated shortages or discontinuations on a public website, and if the situation is unanticipated, within two days of knowing of a shortage or deciding to discontinue a drug; and
• provide information about the implicated drug

Earlier, more comprehensive and reliable information on drug supply disruptions will give healthcare providers more time and confidence to make alternate treatment plans. Proposed new regulations were posted for consultation in the Canada Gazette on June 20 for a 75-day comment period.

Health Canada will also soon issue a request for proposals for a third party to create and administer the new independent reporting website.

Quick Facts

• This announcement followed extensive consultations with Canadians, medical professionals, and other key stakeholders in which there was strong support for mandatory shortage reporting on a non-industry system to ensure Canadians have access timely, reliable and comprehensive drug shortage information.
• The new third-party website, independent from manufacturers, will be established to provide timely, comprehensive and reliable information to Canadians on anticipated and actual drug shortages and discontinuations.
• Canadians will be able to find important information on shortages and discontinuations, as well as details on the actions taken from various players across the supply chain to address shortages and discontinuations,
• While the regulations are being finalized and the public website created, manufacturers are expected to continue voluntarily posting information on all shortages and discontinuances on the industry-run website, www.drugshortages.ca.
• www.drugshortages.ca is an industry-funded, industry-led website launched in March 2012 in response to calls from the then Minister of Health, for manufacturers to make essential information about drug shortages readily available to Canadians and the health care system.
• To reflect and encourage industry accountability, a Public Notification Register has been launched on Health Canada's website that lists all the manufacturers that have committed to voluntarily post their shortages, as well as letters to manufacturers that fail to publicly notify.

Quotes

"By implementing mandatory drug shortage reporting, our Government is further strengthening patient safety in Canada.  Patients and those who care for them need timely and accurate information on the availability of drugs in order to provide proper care. Better, more timely and reliable information will allow the healthcare system to respond more quickly and to minimize the impact of potential drug supply disruptions."
Rona Ambrose
Minister of Health

Associated Links

Harper Government Announces Requirement for Reporting of Drug Shortages

Drug Shortages Public Notification Register

Drugshortages.ca

Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media

SOURCE Health Canada

Michael Bolkenius, Office of the Honourable Rona Ambrose, Federal Minister of Health, [phone]; Health Canada, Media Relations: [phone]; Public Inquiries: [phone], 1-866 225-0709