Health Canada

Health Canada

October 11, 2013 16:40 ET

Government of Canada Takes Action to Protect Canadians

Health Canada accepts recommendations from independent review of Alysena drug recall and commits to improve communication with Canadians

OTTAWA, ONTARIO--(Marketwired - Oct. 11, 2013) - The Government of Canada today outlined actions it will take to communicate more effectively on recall-related risks to the public following an independent report into the recall of Alysena 28 birth control pills.

"Protecting the health and safety of Canadians is a priority for our Government," said Rona Ambrose, Minister of Health. "The independent review has provided timely and practical recommendations to further strengthen the Canadian drug recall system. We are committed to ensuring Canadians get the information they need, as quickly as possible."

The independent review was requested in April 2013 by the Government following the Alysena 28 recall. Ottawa-based Risk Sciences International (RSI) was asked by Health Canada to examine the recall and Health Canada's actions.

The report found that Health Canada followed all recall procedures it had in place to protect Canadians. However, it did outline areas where Health Canada could improve and strengthen communication:

  • Strengthen Health Canada's authority in responding to hazards of drug products;
  • Improve clarity and communication of roles and responsibilities concerning a drug recall - Provide more accessible information on the responsibilities of Health Canada and industry parties in managing risks of drugs in Canada and their roles in drug recalls;
  • Include consideration of level of social concern - Improve guidance on the timely provision of public information on issues of social concern associated with drug recalls, regardless of risk type; and
  • Improve capacity to respond in a more timely fashion - Improve awareness of the 24-7 news and information-sharing environment, and revise procedures to enable and support a prompt, inclusive and appropriate response to an emerging drug recall or risk issue.

Our Government has accepted the report's recommendations, and outlined several actions in response:

  • Health Canada will explore expanded recall powers;
  • Health Canada will work with industry to ensure they provide early notification of drug recalls to the government;
  • Health Canada will commit to doing an additional assessment to consider the impact a drug recall could have on Canadians, in addition to the current health risk assessments presently done according to internationally recognized scientific standards. This approach will mean that recalls such as the one for Alysena 28 will receive the highest possible priority.
  • Health Canada's capacity for a 24/7 response in cases of Type I risks (the most serious) or Type II risks for vulnerable populations will be strengthened.
  • The roles and responsibilities of the various parties in a recall situation will be clarified and communicated to industry, health professionals, the public and the media.
  • Health Canada's risk communication procedures will be made more efficient, and the language used to describe and communicate recalls made more user-friendly.

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Contact Information

  • Media Inquiries:
    Michael Bolkenius
    Office of the Honourable Rona Ambrose
    Federal Minister of Health
    (613) 957-0200

    Health Canada
    Media Relations
    (613) 957-2983

    Public Inquiries:
    (613) 957-2991
    1-866 225-0709