Patients’ experiences on adverse drug reactions reporting: a qualitative study

Abstract

Spontaneous reporting of adverse drug reactions (ADRs) is an important source of information for post-marketing drug safety evaluation. Most countries have public access to reporting systems, but patients report only 3% of all ADRs. Little is known about factors affecting patient reporting. Our aim was to explore patients’ experiences reporting ADRs and their views on the usability of the Canadian Vigilance reporting forms on MedEffect. An interpretive description qualitative study was used. Adults in Canada, who experienced an ADR, were invited to participate through social media (Kijiji, Facebook, Twitter) and by associations (e.g., Patients Canada or Canadian Arthritis Society). Participants were interviewed in English and French using structured interview guides. Inductive content analysis was used. Fifteen interviews were conducted from October 2014 to May 2015. Two participants reported ADRs to MedEffect, and others to physicians and/or pharmacists. Motives for reporting were intolerable side effect impacting daily activities and encouragement from others to report (e.g., family, colleagues). Factors that interfered with reporting were physicians normalized or minimized the side effect, confusion on what to report, no feedback after report submission to MedEffect, and previous experience with side effects. MedEffect forms were described as comprehensive and important, but its usability was affected by the number of questions and complexity of some questions. Most participants were unaware of MedEffect and reported ADRs to physicians and pharmacists. Several barriers and motives affected patients’ reporting of ADRs. MedEffect form could be simplified for use by patients.