Saturday, August 25, 2012

Canada's leaders slammed over drug shortages

Canada needs a national approach to managing its supply of medicines, starting with a mandatory reporting system for drug shortages, two leading professional journals have urged.

Compared with the more decisive action taken by other nations, Canada has demonstrated a lack of preparedness for - and ability to cope with - the recent "unprecedented" levels of shortages, particularly of antiepileptic, chemotherapy, antibiotic and anaesthetic agents, says an editorial published jointly in the Canadian Medical Association Journal (CMAJ) and the Canadian Pharmacists Journal (CPJ).

These shortages result in poorer health, with consequences such as worsening of medical conditions, negative reactions to substitute drugs, cancellation of surgeries and procedures, and increased costs to patients and the health care system, say authors Dr Matthew Standbrook, deputy editor of the CMAJ, and Rosemary Killeen, editor-in-chief of the CPJ.


"This situation will not improve in the foreseeable future without major changes in how Canadian governments - federal, provincial and territorial - respond to it," they warn, and go on to ask: "if governments do not start showing leadership on this issue, who will act in the interest of Canadian patients?"

While Europe and the US require drugmakers to inform governments in advance of possible drug shortages, Canada is relying on industry to establish a voluntary reporting system. But a mandatory reporting system for impending shortages should be created and maintained, so that healthcare stakeholders at all levels have adequate and timely information with which to make decisions, the authors urge.

"Canada cannot cope adequately with a problem of this scope with 14 regional health systems operating independently - federal involvement in this issue is unavailable," they say, and suggest that, with national leadership to manage the issue, Canada could take other steps to minimise the effects of shortages, including:

- expanding the national pharmaceutical stockpile;

- mandating that there must be at least two or more suppliers for essential drugs; and?

- establishing a system to share supplies across the country and to restock quickly from international supplies if there is a shortage.

They also point out that while regulatory authority for drugs belongs to Health Canada, the agency has "only belatedly" started to inform the public about drug shortages and to expedite approval of alternate suppliers of products that have been in short supply.

Moreover, the authors suggest, delays at Health Canada in approving new drugs and production process improvements for existing drugs have likely exacerbated the shortages.

"The people of Canada deserve greater responsiveness and action from their elected officials to safeguard the supply of some of the most critical components of health care delivery," write Dr Standbrook and Ms Killeen.

"It is ridiculous and intolerable that a wealthy, developed nation like Canada cannot reliably provide medicines to its people," they add.

- The "unnecessary" length of Canada's review and approval process for new cancer drugs was strongly criticised last month in a report by the Fraser Institute, a Canadian free-market policy think tank.

Of the 33 oncology drugs slated for market approval between 2003 and 2011, 30 were approved in the US, 26 in the European Union (EU) and just 24 in Canada, it says. And Health Canada took longer to approve every new cancer drug (apart from one) than the US Food and Drug Administration (FDA), where the median review time was 182 days compared to 356 days in Canada.

Moreover, by the end of March 2012, almost 60% of these 24 approved drugs were not covered under public drug plans in any Canadian province, says the Institute.

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Source: http://www.pharmatimes.com/Article/12-08-24/Canada_s_leaders_slammed_over_drug_shortages.aspx

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