Sunday, September 21, 2014

Drug plan had sparked concerns by bureaucrats

TORONTO—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 Canada’s drug supply at risk, documents show.
Records obtained by The Canadian Press indicate civil servants at Health Canada warned in February of last year a voluntary-notice system was “susceptible to bad company behaviour” 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, which leave health practitioners scrambling to get drugs to their patients.
Three weeks later, Health minister Leona Aglukkaq wrote to drug industry associations requesting they voluntarily release information on the increasingly common problem of medication shortages.
The letter to the Canadian Generic Pharmaceutical Association, Rx&D, and BIOTECanada said that “regulatory alternatives” forcing notification would be considered only if it was not possible for the industry to develop a voluntary plan.
Health Canada threw its support behind the resulting system—drawn up with input from health groups—in which drug-makers pledged to post shortage information on a central 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’ 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 Canada to bring forward regulations mandating companies disclose production gaps.
“The website that tracks drug shortages is up and running now because of adopting a voluntary approach,” Outhouse said in an e-mail.
“Regulations can take years to pass, and would mean delays in getting this information to Canadians.”
He added a mandatory system will be considered if manufacturers do not voluntarily comply.
The issue of drug shortages came to the forefront in February when a Sandoz Canada plant providing 90 percent of generic injectable anesthetics and other medications commonly used by hospitals cut production due to a facility upgrade and subsequent fire.
Cancer Society senior analyst Lauren Dobson-Hughes said the advocacy group regularly hears from patients struggling to hunt down therapeutic medications that do not pop up on the drug-shortage website.
“When cancer patients call they say, ‘I cannot get my hands on this drug for love nor money.’ And yet it is not listed [as] short,” she noted.
“We know that drug shortages are increasing but because nobody’s tracking them systemically on a mandatory basis, we still don’t know where or how they’re impacting patients,” Dobson-Hughes added.
The Canadian Press obtained the internal Health Canada 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 Canada—one of several times the department has probed the issue of shortage notices.
The July, 2011 report by Secor Group advised that Health Canada give manufacturers no choice but to provide an immediate alert on outages of drugs produced by one or a small number of manufacturers.
The report came months before Aglukkaq gave final approval to the industry’s voluntary-reporting plan.
Documents show recommendations in favour of a mandatory system date back to late 2010.
During talks with industry and health groups, Health Canada floated a proposal for “a requirement for manufacturers to notify Health Canada of anticipated or occurring drug shortages when it has a public health impact.”
The idea was generally supported by participants, who ruled out a voluntary system, a subsequent memo indicated.
The document stated that one of the “consistent themes” in feedback was that “notification of drug shortages should be mandatory [not in guidance or voluntary] and Health Canada must ensure timely communication of the information.”

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