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Harper Government Announces Requirement for Reporting of Drug Shortages
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Providing clear and concise information on drug shortages to help ensure the health and safety of Canadians
February 10, 2015 – Vancouver, BC – Health Canada
Today, the Honourable Rona Ambrose, Federal Minister of Health was joined by Wai Young, Member of Parliament for Vancouver South to announce that the Government of Canada is advancing regulations that will require manufacturers to publicly report drug shortages in order for Canadians to better plan for their health and safety. By providing advanced warning of upcoming shortages, Canadians will be able to better proactively work with their healthcare professionals to find alternative options.
Unfortunately, drug shortages negatively impact the health of many Canadians and their families every year. As a result, the Government of Canada is moving towards a mandatory reporting system which requires all manufacturers to publicly report drug shortages in order to help Canadians better plan for the health and safety of themselves and their families. Requiring manufacturers to report drug shortages will allow Canadians to better plan for the health and safety of their families by working with their healthcare professionals to find appropriate alternatives in advance of an anticipated shortage.
Timely, comprehensive and reliable information on actual and anticipated drug shortages will be made publicly available by manufacturers on a new, independent third-party website. While this new website and the regulations are being developed, manufacturers are expected to voluntarily post information on all shortages on the industry-run website, www.drugshortages.ca.
To reflect and encourage industry accountability, a Public Notification Register has been launched on Health Canada's website that lists all the manufacturers that fail to voluntarily post their shortages. Once the reporting of drug shortages becomes mandatory, companies will face fines and penalties for failing to comply.
All stakeholders across the healthcare system have important roles to play in addressing drug shortages. Manufacturers, purchasers, provincial and territorial governments and healthcare institutions continue to have an important role in mitigating drug shortages and responding quickly to reduce the impact on patients. The Government of Canada is listening to Canadians and doing its part, and is calling on all stakeholders across the drug supply chain to do theirs.
Minister Ambrose was also joined by The Honourable Terry Lake, Minister of Health for British Columbia, Dr. Douglas DuVal, Vice President, Canadian Anesthesiologists' Society, Suzanne Nurse, Chair of the Drug Shortages Committee for the Canadian Epilepsy Alliance and Mary Ackenhusen, President and Chief Executive Officer of Vancouver Coastal Health.
www.drugshortages.ca is a voluntary industry-led website launched in March 2012 in response to calls from the then Minister of Health for manufacturers to make information about drug shortages readily available to Canadians and the health care system.
Manufacturers have been expected to post all anticipated and actual drug shortages and discontinuances on www.drugshortages.ca as early as possible, to allow maximum time for patients and the healthcare system to react to the shortage.
In September, 2013, Minister Ambrose announced a Protocol and Toolkit to help to prevent and mitigate the impacts of drug shortages.
The current voluntary approach to drug shortage notification, the new Public Register, and the proposed approach to mandatory reporting do not apply to shortages of veterinary drugs natural health products, personal-care products, cosmetic-like drugs, toiletries or disinfectants.
"When drug shortages occur, patients and those who care for them need timely, reliable and comprehensive information to help minimize the impact on their health. Moving to a mandatory system for reporting drug shortages will give doctors, pharmacists, healthcare practitioners and all stakeholders clear and concise information on drug shortages, so they can make the best decisions for their patients. Our Government will continue to take the necessary steps to help ensure the health and safety of Canadians and their families."
Federal Minister of Health
"Drug shortages are a complex global problem with impacts that are felt across the country and the world, but, nobody feels these impacts more than patients and their families. That is why we are taking steps to move to a mandatory system. In the meantime, a Public Register will be hosted on Health Canada's website to name and shame manufacturers who fail to provide voluntary notice making industry commitments, and more importantly, industry actions, clear for all to see."
"British Columbia fully supports this direction toward a more open and transparent prescription drug industry in Canada. "We believe accurate, reliable information about available medications is necessary to improve patient care and avoid poor outcomes for patients."
Terry Lake
Minister of Health for British Columbia
"Drug shortages can have devastating consequences for people living with epilepsy. Ideally there should never be an interruption in the supply of these important medications. What we've been dealing with though have been many shortages, often with no warning, resulting in tremendous fear and in some cases life-threatening complications. Mandatory notification is a key component in improving management of drug shortages."
Suzanne Nurse
Chair of the Canadian Epilepsy Alliance Drug Shortages Committee
Health Canada Seeks Input on Notification of Drug Shortages
Michael Bolkenius
Office of the Honourable Rona Ambrose
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