In an editorial [1], Drs Felicita Andreotti and Filippo Crea said that raising awareness that poor quality drugs exist may cause patients excessive worry, but lack of vigilance could generate distrust by consumers and professionals.

"It is essential to bring the issue to public attention as a first step in reinforcing surveillance," said Dr Andreotti of the Institute of Cardiology at the Catholic University Medical School in Rome, Italy.

The editorial was prompted by the findings of a German research team [2] testing the quality of batches of streptokinase [3] a clot-busting (fibrinolytic) drug widely used in the emergency treatment of heart attacks.

Dr Peter Hermentin and his team from ZLB Behring GmbH in Marburg one of the companies manufacturing streptokinase tested 16 streptokinase preparations (21 samples) for the streptokinase activity, using a validated assay, and found that only three (including their own) matched the minimum fibrinolytic requirements of the European Pharmacopaeia, the European authority on quality and safety of medicines. The activity of the remainder varied from 86% of the claim on the label right down to just a fifth. European Pharmacopaeia demands activity of 90111%. There were also differences in composition and purity.

Said Dr Hermentin: "The dose of fibrinolytic agents such as streptokinase must be carefully controlled to maximise therapeutic activity while avoiding adverse effects. Too low a dose won't restore blood flow in the artery and too high a dose could cause a bleed in the brain.

"While we analysed only one sample from most of the batches albeit testing more than one vial and using two assays i
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Contact: Josie Bate
josiebate@blueyonder.co.uk
44-208-255-1988
European Society of Cardiology
18-Apr-2005