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.