martes, 31 de marzo de 2009

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.

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