Bioethical Issues in Pharmacoepidemiologic Research

Because the bioethical issues involved in pharmacoepidemiologic research are closely related to changing patterns of drug usage and changing technologies of surveillance and data analysis, it is impossible to understand them without attention to historical and sociological perspectives. The field of pharmacoepidemiology emerged as a result of broader recent developments in medical therapeutics, concomitant with 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 briefly introduces historical and sociological dimensions of pharmacoepidemiology from an international perspective, with an eye to commonalities and differences in national variations in ethical approaches to the field.