The burden of adverse drug reactions reported by patients in the Dutch ADR monitor: A proof of concept

Background: We aimed to describe the burden of adverse drug reactions (ADRs) reported by patients participating in the Dutch ADR Monitor using a multifactorial burden measurement instrument.

Methods: The Dutch ADR Monitor is a cohort event monitoring system that collects information on ADR experiences, including burden. This study includes the initial data (November 2022 until May 2023). Patients were asked if experienced ADRs impacted seven domains of burden: appearance, medical treatment, daily life, fatigue, physical consequences, mental consequences, and the course of ADRs. Burden was scored from 0 to 10 on impacted domains. The distributions of these burden scores were demonstrated in Likert plots. The burden between persistent and recurrent ADRs was compared.

Results: Ninety-two patients reported 199 ADRs. Impacts on the domain fatigue and daily life were experienced most frequently, except for skin and subcutaneous tissue ADRs, where impacts on appearance and mental consequences were experienced most frequently. Fatigue was considered the most burdensome domain. No difference in burden was found between persistent (median = 7, IQR = 4) and recurrent ADRs (median = 6, IQR = 4, p = 0.59).

Conclusions: This is the first study investigating burden of ADRs on seven domains in patients with chronic diseases. Impact on the domain fatigue was considered most burdensome.