The burden of adverse drug reactions reported by patients participating in the ADR Monitor

Abstract

Background: Information on the burden experienced from adverse drug reactions (ADRs) is scarce. Insight in the burden patients experience from ADRs could lead to better interventions and increase the quality of life of patients. Objective: To describe the experienced burden of ADRs reported by patients participating in the ADR Monitor. Methods: The ADR Monitor is a prospective cohort event monitoring system, initiated by the Netherlands Pharmacovigilance Centre Lareb, that collects information on the experience patients with chronic disease have with ADRs. Data collected from November 2022 until May 2023 was used. Patients were sent bimonthly questionnaires on experienced ADRs and were asked to assign a score from 0 to 10 on 7 domains regarding the burden of ADRs (impact on appearance, impact on medical treatment, impact on daily activities, fatigue, physical consequences, mental consequences and course). Distributions of the scores assigned to the different domains were made through Likert plots and the burden of ADRs with a constant and recurrent course is compared. Results: Between November 2022 and May 2023 149 patients participated in the ADR Monitor and completed 300 questionnaires. A total of 199 ADRs was reported by 92 patients. Fatigue and impact on daily activities were experienced most often. A clear exception are skin and subcutaneous tissue ADRs, where an impact on appearance and mental consequence were experienced most often. Fatigue was considered the most burdensome. No statistically significant difference between the burden of ADRs with a constant course and ADRs with a recurrent course was found. Conclusions: This is the first study investigating the burden of ADRs on 7 different domains. Patients participating in the ADR Monitor most often experienced fatigue and impact on daily activities as a burden of ADRs. For most ADRs fatigue was considered to be most burdensome.