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Minister rejected drug-shortage concerns

The Canadian Press TORONTO 鈥 The federal health minister opted to let drug makers voluntarily alert doctors and pharmacists of medication shortages despite concerns from her own department that the approach could put sa国际传媒鈥檚 drug supply at risk, doc
The Canadian Press

TORONTO 鈥 The federal health minister opted to let drug makers voluntarily alert doctors and pharmacists of medication shortages despite concerns from her own department that the approach could put sa国际传媒鈥檚 drug supply at risk, documents show.

Records obtained by the Canadian Press indicate civil servants at Health sa国际传媒 warned in February of last year a voluntary-notice system was 鈥渟usceptible to bad company behaviour鈥 that could see firms neglect to report every shortage. An outline comparing voluntary versus mandatory approaches cautioned there would be no way to punish manufacturers who fail to report production gaps that leave health practitioners scrambling to get drugs to their patients.

Three weeks later, Health Minister Leona Aglukkaq wrote to drug industry associations requesting that they voluntarily release information on the increasingly common problem of medication shortages.

The letter to the Canadian Generic Pharmaceutical Association, Rx&D and BIOTEsa国际传媒 said that 鈥渞egulatory alternatives鈥 forcing notification would be considered only if it was not possible for the industry to develop a voluntary plan.

Health sa国际传媒 threw its support behind the resulting system 鈥 drawn up with input from health groups 鈥 in which drug- makers pledged to post shortage information on a website aimed at health professionals and patients. The site, drugshortages.ca, went live in April.

Voluntary reporting has been strongly opposed by the Canadian Cancer Society, the Canadian Anesthesiologists鈥 Society and other health and patient groups. They insist the best way to ensure Canadians reliably get medications such as chemotherapy drugs and antibiotics is for Ottawa to require full disclosure from drug manufacturers on planned or unexpected gaps in production.

Aglukkaq spokesman Steve Outhouse said a voluntary system was chosen because it would take too long for Health sa国际传媒 to bring forward regulations mandating companies disclose production gaps. 鈥淭he website that tracks drug shortages is up and running now because of adopting a voluntary approach. Regulations can take years to pass, and would mean delays in getting this information to Canadians,鈥 Outhouse said in an email.

He added that a mandatory system will be considered by the government if manufacturers do not voluntarily comply.

The issue of drug shortages came to the forefront in February when a Sandoz sa国际传媒 plant providing 90 per cent of generic injectable anesthetics and other medications commonly used by hospitals cut production due to a facility upgrade and subsequent fire.

The Canadian Press obtained the internal Health sa国际传媒 documents on drug shortages through the Access to Information Act.

Other records show a limited form of mandatory reporting was recommended in an exhaustive $25,000 report on drug shortages commissioned by Health sa国际传媒 鈥 one of several times the department has probed the issue of shortage notices.

The July 2011 report by Secor Group came months before Aglukkaq approved the industry鈥檚 voluntary-reporting plan.