PhD defence V. (Victor) Pera

Below is a brief summary of the dissertation:

Various approaches were applied to create an epidemiological overview of medication errors (MEs) and to study select adverse drug events (ADEs). Unstandardized datasets from spontaneous reporting systems (SRSs) were standardized with in-house developed and validated software to facilitate analyses. Utilized SRSs consisted of the European Medicines Agency’s EudraVigilance and the Food and Drug Administration’s Adverse Event Reporting System. Standardized observational data was also obtained from electronic health records forthcoming from the Dutch Integrated Primary Care Information (IPCI) database and the Spanish Information System for Research in Primary Care (SIDIAP). Several insights were obtained. Most ME reports represented females, adults, and elderly, while safety signals were proportionately higher in children. At least one-third of reported MEs were associated with a serious outcome, and most often only one drug was co-reported. Furthermore, reports on parasitic infections associated with the use of biologicals were more frequently reported than expected. The use of long-term macrolide antibiotics has increased in the past years among people with chronic lung diseases while heart monitoring measures were rarely identified in the data of general practices. We showed how our software facilitated ME and ADE research on unstandardized databases and the added value of utilizing available standardized databases. Improvements can still be made in the area of standardization of drug names, drug code assignment, and maintaining self-developed software, while opportunities may be found in resolving data missingness, improving data registration, and analysis on unstructured clinical text data with novel methodologies such as large language models.