What is pharmacoepidemiology? Definition, methods, interest and clinical applications

Therapie. 2019 Apr;74(2):169-174. doi: 10.1016/j.therap.2018.08.001. Epub 2018 Oct 10.


Clinical evaluation of drugs before approval is based on the experimental design of clinical trial with randomization of drug exposure. Unfortunately, conclusions of clinical trials are necessarily limited to patients included into the trials. It is thus necessary to compare these experimental data coming from clinical trials with the real use of drugs in clinical practice. Pharmacoepidemiology is the study of interactions between drugs and human populations, investigating, in real conditions of life, benefits, risks and use of drugs. Pharmacoepidemiology applies to drugs the methods and/or reasoning of both pharmacology and epidemiology. The development of pharmacoepidemiology should improve the "rational drug use".

Keywords: Adverse drug reactions; Clinical evaluation; Drug risk; Drugs; Effectiveness; Efficacy; Pharmacoepidemiology.

MeSH terms

  • Drug Approval
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Humans
  • Pharmacoepidemiology / methods*
  • Product Surveillance, Postmarketing / methods*
  • Randomized Controlled Trials as Topic / methods
  • Research Design