New guidelines will help detect and study counterfeit medicines

March 24, 2009

New guidelines proposed by a group of international experts will help better study the prevalence and geography of counterfeit and other poor quality medicines that threaten public health across the world. The guidelines—called MEDQUARG, which stands for Medicine Quality Assessment Reporting Guidelines—are published in this week's open access journal PLoS Medicine.

A significant proportion of drugs consumed in the developing world are of poor quality, many of which are counterfeit, say the authors, all experts on drug quality working in Kenya, Laos, Thailand, the UK, and the US. This begs the question—how can we translate evidence on best drug treatment outcomes into treatment policy if the medicines actually used have substantially inferior effectiveness compared with the medicines originally evaluated? There are no existing guidelines about the most appropriate sampling and reporting strategies for medicine quality surveys.

Paul Newton and colleagues reviewed previous work on the quality of medicines and discuss the advantages and disadvantages of different study methods, including how to sample medicines for testing. They also reviewed how medicine quality studies have been reported and suggest a checklist of items to be addressed in future studies

The authors invite comment on their guideline proposals, saying that "The objective of the consensus guidelines presented here is to guide surveys of medicine quality and how they are reported, and to provide a template for further development."

More information: Newton PN, Lee SJ, Goodman C, Fernández FM, Yeung S, et al. (2009) Guidelines for field surveys of the quality of medicines: A proposal. PLoS Med 6(3): e1000052. doi:10.1371/journal.pmed.1000052 http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.1000052

Source: Public Library of Science (news : web)