Pharmacovigilance practice among pediatric neurologists from Poland and Germany

Abstract

Abstract Objectives To compare the pediatric neurologists’ knowledge, practice, and barriers to the pharmacovigilance (PV) process in Poland and Germany. Methods The research tool was an online anonymous questionnaire on Google Forms e-mailed to pediatric neurologists from Poland and Germany. Results The questionnaires were handed out to 830 pediatric neurologists and 371 expressed their consent to participate in the study. Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs). Only 34.10% of pediatric neurologists from Poland, and 38.88% from Germany believe that many ADRs are preventable and almost most of them believe it is necessary to report ADRs from children with epilepsy. Unfortunately, in opposite to this knowledge, only 37.79% of respondents from Poland and 40.32% from Germany felt co-responsible for reporting ADRs. The main reason for the neurologists not to report ADRs was a conviction that reporting ADRs would be an additional burden generating extra work. Conclusion There is no big difference between the practice of PV by pediatric neurologists in Poland and Germany. System-regulated PV stabilization in the country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the curricula of academic neurologics courses.

Keywords

• Pharmacovigilance
• Epilepsy
• Children with epilepsy
• Adverse drug reactions
• Drug safety
• Neurologists’ knowledge