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PJ Online homeThe Pharmaceutical Journal
Vol 279 No 7459 p7
7 July 2007

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New MHRA strategy to address counterfeits

Patient safety is the top priority of an investigation into the distribution of counterfeit Casodex, Zyprexa and Plavix, the then health minister Caroline Flint told MPs last month.

She said that the number of patients affected will not be known until the probe by the Medicines and Healthcare products Regulatory Agency is completed, although there have been several class 1 recalls.

Ms Flint added that a new strategy is to be be published later this year by the MHRA to address the risks to patient safety from counterfeit medicines. The aim will be to minimise the risk of bogus products reaching patients through both the regulated and unregulated supply chains.

“This strategy is being reviewed to take into account the recent incidents and subsequent intelligence gathered from industry and our international counterparts,” she said. “The European Commission has recognised that counterfeiting is a growing problem within the EU and has undertaken a study to identify any legislative and regulatory weaknesses with a view to exploring policy options.”

Counterfeits recovery Figures released by the MHRA this week show that only a small proportion of the counterfeit medicines that recently reached the legitimate supply chain were recovered when recalls were issued.

The 2004 recall of Reductil (sibutramine) recovered 61 of the 1,000 packs known to have been sold. In 2005, a recall of Lipitor (atorvastatin) led to 359 of 2,523 counterfeit packs being recovered, while the 2006 recall of the same product led to seven out of 1,867 counterfeit packs being recovered.

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