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Guidelines to aid fight against fake drugs

24 March 2009

Drugs
Trust-funded researchers have developed a set of guidelines to help assess the quality of medicines and combat counterfeit drugs.

Writing in PLoS Medicine, the international panel of drug quality experts outlines recommendations to help research groups study and report the prevalence of fake and poor quality drugs, and indicates where such drugs are commonly available.

A significant proportion of medicines used in the developing world is of poor quality, with many actually counterfeit. These threaten public health programmes against major diseases such as malaria, and raise the risk of drug resistance. Yet little is known about the extent to which fake or substandard drugs have penetrated international markets.

The authors, from Kenya, Laos, Thailand, the UK and the USA, surveyed the limited number of published studies available and reviewed their strategies, techniques and experiences.

Based on this analysis, they produced recommendations on the best sampling strategies, ways of standardising reports on the sampling of drugs and issues that should be addressed in future studies.

"The health of people living in developing countries is critically dependent upon the availability of medicines, and poor-quality medicines are a major impediment to improvements in public health. Despite this there are few reliable data describing their epidemiology, or their effects on health and drug resistance," said Dr Paul Newton, from the Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration in Laos, and lead author on the study.

"Ensuring that essential medicines are of good quality is as important as ensuring that they are available. We hope that this field will attract the interest and support it deserves, and that the recommendations made here will evolve substantially."

Image credit: Worden Sports College, Wellcome Images

Reference

Newton PN et al. Guidelines for field surveys of the quality of medicines: a proposal. PLoS Medicine, 24 March 2009.

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