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

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.

KEYWORDS:

• Drug safety
• pharmacovigilance
• side effect
• spontaneous reporting system
• underreporting

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Author contributions

MG designed and conceptualized the study, interpreted the data, and wrote the manuscript.

BJC designed and conceptualized the study, interpreted the data, and corrected the manuscript.

RZ performed data analysis and wrote and corrected the manuscript.

CSL designed and conceptualized the study, interpreted the data, and corrected the manuscript.

JD designed the questionnaire, performed the statistics and biometric analyses, and wrote and corrected the manuscript.

CL designed and conceptualized the study, created the first draft of the questionnaire, conducted the interviews, and analyzed the data.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Data availability

The data is available on request. Please contact the corresponding author.

Additional information

Funding

This paper was not funded.