PhD defence C.E. (Christel) Hoeve

Dissertation in short:

The focus of this thesis is on medication errors and how regulators deal with them. The research shows how the European adverse event database EudraVigilance can be used to identify signals of medication errors. one signal was investigated further: reports of fatal outcomes in combination with vaccination errors. a systematic case-series analysis showed that in only a few cases the fatal outcome was in fact related to the vaccination error. The research then focused on measures that regulators and medication companies can take to prevent medication errors. It was found that many risk minimization plans of companies described a risk of medication errors but in only few cases additional risk minimization measures were required to
minimize the risk of medication errors. The absolute number of warnings from the European medicines agency (EMA) concerning medication errors was low and reassuring. We
identified a few factors that could be relevant during a new drug application process to minimize the risk of medication errors in the future. We studied further to what extend prescribers adhere to recommendations to reduce mediation related hospital admissions. We identified areas for improvement: electrolyte monitoring, gastric protection for high-risk NSAID/ASA users, more adequate prescription to prevent fractures in elderly due to falls as a consequence of benzodiazepine use or fractures associated with use of glucocorticosteroid patients and digoxin/sotalol prescriptions in elderly. Our research also showed that LAMA monotherapy increases the risk of severe asthma exacerbations compared to treatment with LAMA in combination with ICS as per the guidelines.