Regulatory Focus™ > News Articles > Medical Journal Calls for National Approach to Canadian Drug Shortage Crisis

Medical Journal Calls for National Approach to Canadian Drug Shortage Crisis

Posted 21 August 2012 | By Alexander Gaffney, RAC 

Pharmacists and patients in Canada are experiencing frequent drug shortages as the result of numerous and complex factors, leading the Canadian Medical Association Journal (CMAJ) to call for a national approach to managing the crisis.

Writing in the 20 August edition of CMAJ, Dr. Matthew Stanbrook, deputy editor of CMAJ and Rosemary Killeen, editor-in-chief of the Canadian Pharmacists Journal, explained the shortages are increasing in severity and scope, resulting in an "unprecedented" problem.

"This situation will not improve in the foreseeable future without major changes in how Canadian governments, federal provincial and territorial, respond to it," Stanbrook and Killeen wrote. "It is ridiculous and intolerable that a wealthy, developed nation like Canada cannot reliably provide medicines to its people."

As in the US, many of the shortages affect older generic medications, and in particular sterile injectable medications, many of which are single-source and subject to severe supply disruptions if even one manufacturing  facility closes down. Though the authors acknowledge the reasons for the shortages are legion, they argue the response by Canadian health regulators thus far is characterized by a, "Lack of preparedness for and ability to cope with this problem."

"Despite warnings from a variety of stakeholders in 2010 and 2011, the federal government's response to this alarming problem has, to date, been inadequate," the authors wrote. Legislators only began to pay attention to the issue, they said, when a fire at a manufacturing facility owned by Sandoz interrupted the supply of many generic injectable drugs, causing widespread shortages.

Regulators Respond

The problem led to Health Canada announcing it would expedite the review of 23 new drug applications to ease the growing shortages, announcing it would take just one month to make a regulatory decision instead of the usual six. Stanbrook and Killeen noted in their editorial that the lengthy approval of some drugs had "likely exacerbated" the shortages of some drugs.

Regulators would later borrow a tactic from the US Food and Drug Administration (FDA) and allow closely monitored but unapproved drug analogues into the country on a short-term, controlled basis. The drugs would need to originate from countries where Canada has a relationship with a "trusted regulator," officials said.

CMAJ Recommendations

Stanbrook and Killeen said regulators should do more to borrow from the tactics of other countries, including requiring companies to inform Health Canada if they are experiencing or anticipate a shortage situation. The move was credited by the authors as leading to a six-fold increase in the number of shortages reported and a two-fold increase in the number of shortages averted with the help of regulatory assistance.

Stanbrook and Killeen chided Canadian health officials for instead insisting on a voluntary system rather than a compulsory one. They wrote, "If governments do not start showing leadership on this issue, who will act in the interest of Canadian patients?" The authors also called for greater coordination between regional governments, saying the crisis could not be adequately addressed without cooperation, and the formation of a more robust pharmaceutical national stockpile to include drugs likely to experience shortages.


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