pharmacoepidemiologie

Pharmacoepidemiologie is the study of the use and effects of medicines in large populations. It aims to describe how drugs are prescribed and taken in real-world settings, to identify safety signals, and to evaluate the real-world benefits and risks of medications beyond what is observed in controlled trials. The field supports clinical decision making, regulatory assessment, and health policy by linking drug exposure to health outcomes across diverse patient groups.

Methodologically, pharmacoepidemiologie relies on observational study designs such as cohort studies, case-control studies, nested case-control studies, and self-controlled designs. Data sources include administrative claims databases, electronic health records, patient registries, and spontaneous adverse-event reporting systems. Outcomes analyzed range from adverse drug events to measures of effectiveness and patterns of drug use.

Effect estimates typically involve risk ratios, odds ratios, and hazard ratios to quantify associations between drug exposure and outcomes. Analysts address confounding and bias with methods such as propensity score adjustment, active-comparator and new-user designs, instrumental-variable analyses, and comprehensive sensitivity analyses. Ethical considerations include patient privacy, data security, and careful interpretation of results given the observational nature of most evidence.

Applications of pharmacoepidemiologie include post-marketing surveillance, comparative effectiveness research, drug utilization studies, and the ongoing evaluation of labeling, dosing, and formulary decisions. The field faces challenges related to data quality, misclassification, residual confounding, and generalizability across different health systems and populations. Historically, it emerged in the mid-to-late 20th century in response to safety concerns about medications and to support evidence-based regulation, and it now intersects with pharmacovigilance, epidemiology, and health services research to promote safer and more effective drug use.