Meer, D.S.van der (2020) Methods of mapping adverse events of medicine use during pregnancy. Master's Thesis / Essay, Medical Pharmaceutical Sciences.
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Abstract
The current system of verifying and quantifying adverse reactions to drug use during pregnancy is disparate. Pharmacovigilance methods play an important part in protecting pregnant women from the possible harmful effects of the use of drugs during their pregnancies. The main aim of this study was to identify methods used for assessment of the relationship between drug use and adverse events during pregnancy. A secondary aim was to determine the quality of the methods for which this is useful. In MEDLINE (Pubmed) articles about methods for assessment of the relation between drug use during pregnancy and adverse events were selected and studied following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) guidelines. Advantages and disadvantages were retrieved from the included articles. The found methods for mapping adverse events of medicine use during pregnancy were case-control studies, cohort studies, case reports and case series, data-linkage, the use of real-world data and prescription event monitoring. The methods used for mapping adverse events of medicine use during pregnancy found in this study have their own advantages and disadvantages. The best method to use depends on the settings and circumstances of the pharmacovigilance method. The use of real-world evidence generation seems to become a valuable method for evidence generation of the association between adverse events and medicine use during pregnancy in pregnancy pharmacovigilance.
| Item Type: | Thesis (Master's Thesis / Essay) |
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| Supervisor name: | Puijenbroek, E.P. van |
| Degree programme: | Medical Pharmaceutical Sciences |
| Thesis type: | Master's Thesis / Essay |
| Language: | English |
| Date Deposited: | 16 Dec 2020 10:29 |
| Last Modified: | 16 Dec 2020 10:29 |
| URI: | https://fse.studenttheses.ub.rug.nl/id/eprint/23710 |
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