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Mar 28, 2012

http://www.fiercepharmamanufacturing.com/story/fire-sandoz-plant-complicates-drug-shortages/2012-03-13

 

A shortage of injectable cancer drugs in Canada has been exacerbated by a fire at a Sandoz plant that had already reduced production to fix GMP issues.

The complications caused some Canadian hospitals to delay procedures and has prompted the office of Health Minister Leona Aglukkaq to complain about how Sandoz, a unit of Novartis ($NVS), is keeping authorities apprised.

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"We're really concerned about how Sandoz has handled this situation, and if a voluntary approach isn't what ultimately gets this information into the hands that need it, we are open to other solutions, including regulation," explains Steve Outhouse, a spokesman for the health ministry, according to The Globe and Mail.

The fire broke out in a boiler room ceiling of the Boucherville, Quebec, Canada, plant March 4. A statement on the Sandoz website says the company has restarted production in the portion of the plant not directly affected by the incident. "Production at the site is prioritized around essential products to help ensure continued supply of critical drugs to patients," it adds.

The fire came after the company had already cut production of some products--including non-medically necessary injectable drugs--so it could ramp up remediation efforts. In a letter to customers last month, Sandoz said the company "has been working diligently to improve quality operations across all manufacturing sites," but because of  "issues raised by the FDA, Sandoz Canada has expanded the remediation actions already [under way] and has opted to discontinue certain products and temporarily suspend the production of other injectable products."

The company warned of shortages, but it said the suspension would allow it to focus on sterile injectable production and the supply of critical injectable medicines. The fire changed that. Now medical providers are getting very concerned about having enough drugs to treat patients.

"In regards to medication issues, this is one of the most significant challenges we've faced in recent memory," said Michael Cohen, VP of clinical services at the Queensway Carleton Hospital in Ottawa, according to The Globe and Mail. "The scope and potential impact are significant."

 

- see The Globe and Mail story




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Posted: Mar 28, 2012 8:21pm

 

 
 
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