Résumé
Introduction: Pharmacoepidemiology is defined as "the science that investigates the use and action of drugs on a large population scale” according to the World Health Organization. The aim of this review is to highlight the important role of pharmacoepidemiology and its research standing in Greece. Methodology: For this literature review, articles and relative information was extracted using the academic search engines and databases Google Scholar, PubMed, Scopus and Science Direct. The review includes literature content from 1972 to 2021 and the keywords that were used for the literature search are "Pharmacoepidemiology”, "clinical research”, "clinical studies”, and "Pharmacovigilance”. Results-Discussion: Fundamental aims of Pharmacoepidemiology are: a) the enhancement of clinical research with the collection and analysis of Real-World Data, b) the detection of potential side effects of pharmaceutical products and c) the study/investigation of new therapeutic actions of pharmaceutical products for their beneficial use beyond their main known action. Additional reasons that make it crucial to conduct pharmacoepidemiologic studies nowadays are related to regulatory, legal, marketing, and clinical research evolvement factors. The main tools of Pharmacoepidemiology are: (i) advanced epidemiological methods which are applied to clinical research data and (ii) databases that have been developed significantly in recent years due to the progress of computer science and big data analytics. Some of the main resources of real-world data used in pharmacoepidemiologic science are drug prescription-cost related data, health insurance databases, and government related resources. The types of the studies that are used to conduct a pharmacoepidemiologic research are: i) descriptive studies (reports/case series and ecological or cross-sectional studies) aiming to enhance drug safety and pharmaceutical risk assessment and ii) analytical studies (case control and cohort studies) aiming to highlight the cause-effect relationships and detect risk-disease factors. However, despite the excellent design of a pharmacoepidemiologic research study, there are limitations related to the quality of data (primary/secondary) obtained and analyzed but also the population group size studied. There are also further limitations such as bias and recall bias, confounding factors, lack of organized valid large databases for research purposes that may pose an important burden to the proper design of a study. Finally, the reliability of a pharmacoepidemiologic study is very crucial based on its statistical power as defined by the confidence intervals and the large and well-defined/represented population sample. It is worth mentioning that the contribution of pharmacoepidemiology was highlighted significantly during the Covid-19 pandemic as a key pharmacovigilance tool that has identified and recorded serious and rare side effects of the new, innovative vaccines against the coronavirus disease. Conclusion: Pharmacoepidemiology studies are truly valuable since they can also act as a complementary assessment tool to the formation and updates of clinical guidelines. In Greece, the scientific field of pharmacoepidemiology is still in very early foundation stage, although there are groups of Greek scientists-researchers in recent decades that they have been trying through their work to develop and evolve this fascinating scientific field. © 2023, Zita Medical Managent. All rights reserved.