PLoS: Guidelines Quality of medicines...

March 24, 2009

Summary Points

• Despite evidence suggesting that substandard, counterfeit, or degraded medicines are major problems of global importance, there are few reliable data describing their epidemiology.
• Poor-quality medicines particularly affect lower-income countries, where information and drug regulation enforcement is scant, but inadequate infrastructure, non-regulated drug outlets, and black market operations make drug quality surveys difficult.
• We reviewed previous work on the quality of medicines and how medicine quality studies have been reported. We discuss best sampling strategies and suggest a draft checklist of appropriate items to be addressed in future studies.
• More research on medicine quality monitoring methodologies is needed, together with a standardisation of medicine collection protocols. The objective of the guidelines presented here is to guide surveys of medicine quality and how they are reported, and to provide a template for further development.