Health Canada Backs Drug Shortages Reporting System

Shortages of prescription drugs -- the same issue that prompted a Dec. 15 interim final rule from HHS to require manufacturers of some critical drugs to report manufacturing interruptions to FDA –- also is prompting Canadian action.

Health Canada has announced it wants industry and health care professional associations to establish a national system for monitoring and reporting drug shortages next year and also encourages manufacturers to work cooperatively to prevent drug shortages by addressing their root causes.

In America, HHS took a different route to the same end by issuing an interim final rule Dec. 15 requiring manufacturers of certain critical drugs to report manufacturing interruptions to FDA. This followed an Oct. 31 executive order from President Obama telling FDA and the Justice Department to take action on drug shortages.

"Shortages delay or deny needed care for patients and FDA is committed to making sure that patients and health professionals have the drugs they need when they need them," said FDA Commissioner Dr. Margaret Hamburg. "We will continue to take steps such as issuing this interim final rule to prevent and reduce current and future disruptions in the supply of lifesaving medicines."

Health Canada asked drug industry associations, the health care industry, and pharmacy interests in March 2011 to find solutions to the problem. This request produced a plan at the end of September 2011 in which the industry committed to posting drug shortage information on two existing public websites: the University of Saskatchewan’s Saskatchewan Drug Information Services and Ruptures d'approvisionnement en médicaments au Canada.

Health Canada says drug shortages are a global challenge. They are temporary supply interruptions that may be caused by a manufacturer's removal of a product from the market; a mishap such as a mass product loss in shipping; a pause in production as the company makes manufacturing improvements to meet quality standards; or worldwide shortages of raw materials needed to make a certain product.

Health Canada said it has consulted with FDA, among others, to assess the problem and responses to it in other countries.

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