Pharmacoepidemiology: An Overview

Overview

Journal J Clin Med

Specialty General Medicine

Date 2023 Nov 25

PMID 38002647

Authors

Monica Sabate

Eva Montane

Affiliations

Soon will be listed here.

Abstract

The aims of this review are to provide a comprehensive overview of the definition and scope of pharmacoepidemiology, to summarize the study designs and methodologies used in the field, to discuss the future trends in the field and new methodologies to address bias and confounding, and finally to give some recommendations to clinicians interested in pharmacoepidemiologic research. Because drug efficacy and safety from randomized clinical trials do not reflect the real-world situation, pharmacoepidemiological studies on drug safety monitoring and drug effectiveness in large numbers of people are needed by healthcare professionals and regulatory institutions. We aim to highlight the importance of pharmacoepidemiologic research in informing evidence-based medicine and public health policy. The development of new designs and methodologies for the generation of valid evidence, as well as new initiatives to provide guidance and recommendations on how to incorporate real-world evidence into the drug development process, are reported on. In addition, we have touched on the implication of artificial intelligence in the management of real-world data. This overview aims to summarize all important aspects to consider when conducting or interpreting a pharmacoepidemiologic study.

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References

Bothwell L, Greene J, Podolsky S, Jones D . Assessing the Gold Standard--Lessons from the History of RCTs. N Engl J Med. 2016; 374(22):2175-81. DOI: 10.1056/NEJMms1604593. View

Spitzer E, Cannon C, Serruys P . Should real-world evidence be incorporated into regulatory approvals?. Expert Opin Drug Saf. 2018; 17(12):1155-1159. DOI: 10.1080/14740338.2018.1546842. View

Linden A . Using group-based trajectory modelling to enhance causal inference in interrupted time series analysis. J Eval Clin Pract. 2018; 24(3):502-507. DOI: 10.1111/jep.12934. View

Delaney J, Suissa S . The case-crossover study design in pharmacoepidemiology. Stat Methods Med Res. 2008; 18(1):53-65. DOI: 10.1177/0962280208092346. View

Bakker E, Plueschke K, Jonker C, Kurz X, Starokozhko V, Mol P . Contribution of Real-World Evidence in European Medicines Agency's Regulatory Decision Making. Clin Pharmacol Ther. 2022; 113(1):135-151. PMC: 10099093. DOI: 10.1002/cpt.2766. View

Franklin J, Shrank W, Pakes J, Sanfelix-Gimeno G, Matlin O, Brennan T . Group-based trajectory models: a new approach to classifying and predicting long-term medication adherence. Med Care. 2013; 51(9):789-96. DOI: 10.1097/MLR.0b013e3182984c1f. View

Evans S . Pharmacoepidemiology. Br J Clin Pharmacol. 2012; 73(6):973-8. PMC: 3391530. DOI: 10.1111/j.1365-2125.2012.04248.x. View

Kurz X, Perez-Gutthann S . Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Pharmacoepidemiol Drug Saf. 2018; 27(3):245-252. PMC: 5873428. DOI: 10.1002/pds.4381. View

Moher D, Liberati A, Tetzlaff J, Altman D . Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009; 6(7):e1000097. PMC: 2707599. DOI: 10.1371/journal.pmed.1000097. View

10.

Wertheimer A, Andrews K . An overview of pharmacoepidemiology. Pharm World Sci. 1995; 17(3):61-6. DOI: 10.1007/BF01875433. View

11.

Vrijens B, de Geest S, Hughes D, Przemyslaw K, Demonceau J, Ruppar T . A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012; 73(5):691-705. PMC: 3403197. DOI: 10.1111/j.1365-2125.2012.04167.x. View

12.

Acton E, Willis A, Hennessy S . Core concepts in pharmacoepidemiology: Key biases arising in pharmacoepidemiologic studies. Pharmacoepidemiol Drug Saf. 2022; 32(1):9-18. PMC: 10204604. DOI: 10.1002/pds.5547. View

13.

Montastruc J, Benevent J, Montastruc F, Bagheri H, Despas F, Lapeyre-Mestre M . What is pharmacoepidemiology? Definition, methods, interest and clinical applications. Therapie. 2018; 74(2):169-174. DOI: 10.1016/j.therap.2018.08.001. View

14.

Fujinaga J, Fukuoka T . A Review of Research Studies Using Data from the Administrative Claims Databases in Japan. Drugs Real World Outcomes. 2022; 9(4):543-550. PMC: 9712845. DOI: 10.1007/s40801-022-00331-5. View

15.

Crescioli G, Bonaiuti R, Corradetti R, Mannaioni G, Vannacci A, Lombardi N . Pharmacovigilance and Pharmacoepidemiology as a Guarantee of Patient Safety: The Role of the Clinical Pharmacologist. J Clin Med. 2022; 11(12). PMC: 9225198. DOI: 10.3390/jcm11123552. View

16.

Liu F, Panagiotakos D . Real-world data: a brief review of the methods, applications, challenges and opportunities. BMC Med Res Methodol. 2022; 22(1):287. PMC: 9636688. DOI: 10.1186/s12874-022-01768-6. View

17.

Bates D, Evans R, Murff H, Stetson P, Pizziferri L, Hripcsak G . Detecting adverse events using information technology. J Am Med Inform Assoc. 2003; 10(2):115-28. PMC: 150365. DOI: 10.1197/jamia.m1074. View

18.

Onakpoya I, Heneghan C, Aronson J . Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC Med. 2016; 14:10. PMC: 4740994. DOI: 10.1186/s12916-016-0553-2. View

19.

Barnett M, Khosraviani V, Doroudgar S, Ip E . A narrative review of using prescription drug databases for comorbidity adjustment: A less effective remedy or a prescription for improved model fit?. Res Social Adm Pharm. 2021; 18(2):2283-2300. DOI: 10.1016/j.sapharm.2021.06.016. View

20.

Lipsitch M, Tchetgen Tchetgen E, Cohen T . Negative controls: a tool for detecting confounding and bias in observational studies. Epidemiology. 2010; 21(3):383-8. PMC: 3053408. DOI: 10.1097/EDE.0b013e3181d61eeb. View