The Canadian Government has made it mandatory for drug companies to report actual and anticipated drug shortages. A voluntary system that had been in place was not working well enough, said the country’s Health Minister, Rona Ambrose.
Canada clamps down on companies failing to post drug shortage information
Home/Pharma News | Posted 27/02/2015 0 Post your comment
Pharmaceutical companies that fail to post public notices when drugs are not available will be fined. Companies in the US are already required to notify the Food and Drug Administration (FDA) about shortages, including the reasons and expected duration [1]. This action by FDA came after a study showed that the number of drug shortages in the US had tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care [2].
‘When drug shortages occur, patients and those who care for them need timely and accurate information,’ said Ms Ambrose.
Several pharmaceutical companies based in Canada, including Merck Canada and Bristol-Myers Squibb Canada, have openly supported the move, adding that generics companies are connected with most drug shortages. In response, Mr Jeff Connell, Vice President of Corporate Affairs for the Canadian Generic Pharmaceutical Association, noted that for some brand-name drugs there may be up to 12 generic versions.
‘Simple mathematics dictates that if, for example, there is a shortage of an active ingredient used to make a drug, this will impact one brand-name drug manufacturer but several generic drugs manufacturers,’ said Connell.
Canada’s struggles with drug shortages have been ongoing for some time. Health Canada announced in 2013 plans to address drug shortage problems, including a national protocol for the public notification of drug shortages and a toolkit that identifies steps that can be taken to prevent and reduce the impact of drug shortages [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA announces two actions to combat drug shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Pharma-News/FDA-announces-two-actions-to-combat-drug-shortages
2. Perks B. Drug shortages hit US oncologists hard. Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(1):6-7. doi:10.5639/gabij.2014.0301.002
3. GaBI Online - Generics and Biosimilars Initiative. Health Canada announces plans to tackle drug shortages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 27]. Available from: www.gabionline.net/Policies-Legislation/Health-Canada-announces-plans-to-tackle-drug-shortages
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Source: Government of Canada, Reuters
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