Drug shortage feared after generics maker Sandoz suspends production

A major generic drug company in Quebec has been forced to suspend production of many of its pharmaceutical products and to discontinue the production of other medicines, raising concerns of a possible drug shortage in the province. 

Sandoz Inc., which employs 800 people at its Boucherville plant, manufactures several hundred medicines, including injectable cancer drugs, antibiotics and morphine for gravely ill people. Some of their formulations cannot be easily obtained elsewhere, according to Quebec pharmacists. 

Sandoz said in a statement Saturday that ``there will be a significant reduction in output from our Boucherville plant.'' 

It added that ``our objective is to restore normal levels of supply as soon as possible.'' 

Sandoz was forced to reduce production and begin upgrading its facilities after the U.S. Food and Drug Administration (FDA) cited it for various deficiencies relating to the safety and reliability of its production methods. 

In a letter dated Feb. 15, Sandoz informed hospitals and pharmacists in Quebec that it has decided to stop the production of certain drugs and injectable products as it works to improve its production methods. 

Sandoz states that this work will affect all aspects of production and will ``substantially reduce the sale of products from our plant.'' 

Sandoz said it has shut down production of ointments, eye medicines and suppositories. The company said that it will continue to produce essential medicines for people who are gravely ill. But it added that, in some cases, it will be forced to reduce the number of formulations of these drugs, forcing patients and doctors to modify their treatments. 

Diane Lamarre, president of the Quebec Order of Pharmacists, said Saturday that Sandoz's problems could lead to shortages of many important drugs in Quebec. 

She complained that Sandoz has not revealed the seriousness of the situation. 

``What we know is that many products will be involved in this kind of drug shortage,'' she said. 

She said occasionally there are shortages of one or two products in Canada, but ``this kind of shortage with Sandoz will involve a lot of medications.'' 

``If they decrease their production to 50 or 75 per cent, there will certainly be some patients who will suffer,'' she said. ``So we would like (Sandoz) to answer these questions, to explain what they plan to do.'' 

Lamarre said part of the problem is the merging of pharmaceutical companies, which can create serious problems of shortages when a company has to reduce or suspend production. 

``It means that we don't have that many choices any more,'' she said. ``Because Sandoz is a major producer of injectable drugs, I think we will have to deal with real shortages.''

Lamarre called on governments and industry to come together with backup plans in cases of shortages. 

``Drugs are not just another product,'' she said. ``Medications are essential for many patients. We cannot be in a situation where we are not sure if these medicines will be available.'' 

Jean-FranCois Bussieres, chief of the pharmacy department at Ste. Justine Hospital in Montreal, said that it is not yet clear if Sandoz's production problems will affect the availability of critical medicines in Quebec. 

``There have been supply disruptions over the last few years for a few drugs, so it is not a new situation,'' he said. ``But what is serious here is that they make several injectable medicines such as intravenous drugs where there are no alternatives; there are no other manufacturers.'' 

He said the FDA is essentially requiring Sandoz to upgrade its production methods, which means a universal slowdown in all its production. 

According to an FDA letter sent to the company on Nov. 18, 2011, investigators found ``significant violations of the Current Good Manufacturing Practice (CGMP) regulations for finished Pharmaceuticals'' during three visits to the plant in 2011. 

The letter goes on to state that ``these violations cause your drug products to be adulterated.'' 

The letter also charges that an August 2011 inspection of the plant revealed that Sandoz Canada had failed to report contamination or deterioration in some drug products. 

The FDA also stated that the company had failed to take ``sufficient corrective action'' after the FDA warned it about the problems.

``Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile,'' the FDA letter states. 

The FDA threatened to bar the company's products from the U.S. market unless it meets FDA standards. 

Sandoz is owned by Sandoz International GmbH, the second-largest generics manufacturer worldwide, with sales of $8.5 billion. It is a subsidiary of the Swiss multinational company Novartis. 

In addition to its current problems, Sandoz had to recall drugs in 2008 and 2010, according to FDA filings.

Source: Canada.com