Reporting, handling, and subjective importance of adverse drug reactions among general practitioners: an exploratory cross-sectional survey

Abstract

ABSTRACT Background: Interventions for improving reporting and management of adverse drug reactions (ADRs) need regular evaluations of attitude and knowledge of health care professionals regarding pharmacovigilance. Research design and methods: An exploratory survey among general practitioners in Germany was conducted. Results: We interviewed 302 individuals (participation rate 34.3%; mean age 54 yrs; 37.1% female). Underreporting was prevalent in the sample (only 16.6% had reported an ADR in 2015; average total number of ADR-reports was 5). We found awareness of the importance of pharmacovigilance and ADRs, information deficits (43% were not aware of the obligation to report ADRs), and several uncertainties regarding the detection and reporting of ADRs. The participants rated the German ADR reporting system as satisfactory (mean grade 3.7 ± 1.2) and criticized the expenditure of time (63.6%) and the overall complexity (47.4%). To increase the motivation to report ADRs, the majority requested the possibility to report by telephone (61.3%), feedback after reporting (49.3%), telephone consultations (47.4%), and more education and training in pharmacovigilance (31.1%), also during medical school (25.8%). Conclusions: We found evidence of objective and subjective need for further (mandatory) education and training in pharmacovigilance, already during medical school. Our results point to some shortcomings of the German pharmacovigilance system.