Healthcare professionals’ pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates

Abstract

Background: Spontaneous adverse drug reaction (ADR) reports prepared by healthcare professionals (HCPs) are the backbone of collecting post-marketing safety data. However, underreporting is a global problem creating health, economic, and ethical burden.Objectives: To determine the factors limiting ADR reporting rates from the HCPs’ point of view.Methods: A questionnaire containing 43 questions evaluating sociodemographic characteristics, pharmacovigilance knowledge and activities, and prescription behaviors was prepared on “surveymonkey.com.” The link was distributed mainly by professional organizations.Results: Although this survey aimed to reach all HCPs, most of the respondents were physicians and nurses. Of the 259 (69.6%) participants who encountered ADR at least once, only 105 (40.5%) reported ADR. The term “pharmacovigilance” was heard for the first time in this survey by 35.5% (n = 132) of the participants. Only 34.7% (n = 129) of the participants knew where to find the ADR reporting form, and 25.5% (n = 95) had previously filled the form and/or read it. Only 28.5% (n = 106) of the participants were aware of the ADR reporting and monitoring system of their institutions and related professionals. Almost all the participants agreed that pharmacovigilance and ADR reporting training are necessary.Conclusion: The main reason for underreporting is limited pharmacovigilance knowledge of HCPs. Training activities based on the needs and preferences of HCPs and close follow-up by authorities are the main steps to improve pharmacovigilance activities.