Pharmacoepidemiology: regulatory basis, methodological approaches and scope

ABSTRACT

Pharmacoepidemiology is a discipline that studies the use of drugs and evaluation of their beneficial or adverse effects on large populations. It requires compliance with laws and maintaining a regulatory approach in order to ensure confidentiality and protection of personal data. It also requires good knowledge of drugs and diseases and the use of the different available data sources. Pharmacoepidemiology incorporates epidemiological methods [cohort, case-control and cross-sectional studies] where the exposure is drug intake. These methods must be applied at the conception of the pharmacoepidemiological study in order to minimize the effect of bias hich can lead to false conclusions. This paper reviews the regulatory basis, methodological approaches and scope of pharmacoepidemiology