Bioethical Issues in Pharmacoepidemiologic Research

The field of pharmacoepidemiology emerged as a result of broader recent developments in medical therapeutics, concomitant to the expansion and refinement of the field of bioethics. Some key bioethical principles relevant to pharmacoepidemiologic research have remained significant over time; others have only gained attention in recent years. This chapter explores the emergence and conduct of pharmacoepidemiologic research in global settings in which the field developed and some of the key challenges, tensions, and trends in historic and current international ethical policies toward pharmacoepidemiology. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance was established in 2006 and is coordinated by the European Medicines Agency. Numerous critical ethical concepts took hold early in pharmacoepidemiology and have remained significant over time. The International Society for Pharmacoepidemiology has created Guidelines for Good Pharmacoepidemiology Practice, which provides a model for key pharmacoepidemiology research ethics policies. Transparency has been stressed as a key element for ensuring ethical pharmacoepidemiologic practices.