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Much of medical research is devoted to improving the diagnosis and determining the optimum medical therapy and dose regimens for diverse diseases. This evidence is crucial in allowing evidence-based decisions for the treatment of individual patients and for determining public health policy. However, a key aspect of translation of such evidence into patient care, the quality of medicines that patients actually take, has been neglected.  There has been little research and there are no reliable data on the frequency of poor quality medicines, of the two main types "“ counterfeit (fake) and substandard, anywhere for any group of medicines. 

However, there are numerous tragic examples, such as paracetamol syrup containing renal toxins, antimalarials containing no active ingredients and oral contraceptive pills containing flour. Many of these are clearly counterfeit, sophisticated copies made by criminals, that are very hard to distinguish from the genuine but with no therapeutic benefit.

Most of the surveys have involved 'convenience' sampling with little or no attempt made to provide an unbiased estimate - making it impossible to reliably estimate the extent of the problem and to follow changes through time. Reporting has been haphazard making it very difficult to understand what was done. A group of those involved in such work have therefore collaborated on a first attempt to discuss the problems of sampling and reporting of medicine quality surveys. They have drafted Medicine Quality Assessment Reporting Guidelines (MEQARD), which are included in the paper posted here.

We would be very grateful for any comments and criticisms of this "“ we are anxious to engage as many people as possible with an interest in the subject and to develop a consensus document which can be improved as more data and experience becomes available. We hope to submit the paper in mid-September 2008.

Please send your comments to Paul Newton, email: paul@tropmedres.ac


Posted by:

Paul Newton
Wellcome Trust-Mahosot Hospital-Oxford University Tropical
Medicine Research Collaboration, Mahosot Hospital, Vientiane, Lao PDR
& CCVTM, Churchill Hospital, University of Oxford, England, UK OX3 7LJ