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London (pte028/19.04.2005/12:30) - Substandard medications are available in countries across the world, researchers have warned. As the BBC http://www.bbc.co.uk reports, heart experts looked at samples of a clot-busting drug sold in countries outside the European Union. Testing found only three out of 16 samples tested met minimum EU requirements. Writing in the European Heart Journal, the researchers warned that more global awareness of the problem of substandard drugs was needed. According to the UK's Medicines and Healthcare Products Regulatory Authority (MHRA), a strict system of checks ensure that drugs marketed to the NHS met certain standards. Although counterfeit drugs do occasionally come to light, they tend to be of more saleable products such as Viagra.
The warning over the availability of substandard drugs around the world came following tests carried out by German researchers. A team from ZLB Behring GmbH http://www.zlbbehring.com in Marburg tested 16 versions of streptokinase - a clot-busting drug used in the emergency treatment of heart attacks to see if they contained enough streptokinase to be effective. If it is administered within an hour of a heart attack, an effective dose of streptokinase can cut the risk of dying by over a quarter. The drugs had been on the market in several non-EU countries, Brazil, India, Jordan, China and Pakistan. They found only three, including one made by ZLB Behring GmbH matched European requirements for the quality and safety of medicines. The activity of the remainder varied from 86 per cent of the claim on the label right down to just a fifth. The European regulator, the European Pharmacopaeia requires activity of between 90 to 111 per cent. The analysis also found differences in composition and purity.
"The discrepancy between claimed and actual activity of many streptokinase preparations could cause life-threatening situations in severely ill patients," said Peter Hermentin, who carried out the tests. "It's essential that we acknowledge the problem of counterfeit and substandard drugs and recognise it without embarrassment," added Felicita Andreotti of the Institute of Cardiology at the Catholic University Medical School in Rome. "It is a serious problem, particularly in the case of life-saving medications used to treat common diseases. Regardless of whereabouts, it would be a pity if emergency treatment were useless. Getting this right is a global responsibility."
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