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

ABSTRACT

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 7 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

92 patients reported 199 ADRs. Impact on the domains fatigue and daily life were experienced most frequently, except for skin and subcutaneous tissue ADRs, where impact 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 7 domains in patients with chronic diseases. Impact on the domain fatigue was considered most burdensome.

Summary

• Patients with skin and subcutaneous ADRs experienced impact on appearance and mental consequences most often, but found impact on fatigue most burdensome.

• For most reported ADRs, patients scored the highest burden on the domain fatigue and thus found impact on this domain to be the most burdensome.

• Patients with skin and subcutaneous ADRs experienced impact on appearance and mental consequences most often, but found impact on fatigue most burdensome.

KEYWORDS:

• Adverse drug reactions
• Burden
• Likert plots
• Pharmacovigilance

Disclaimer

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Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

Ethical approval was waived for the Dutch Medical Research Involving Human Subjects Act (WMO) by the Medical Research Ethical Committee of Brabant, the Netherlands (file number: NW2022-76). The Dutch ADR Monitor was approved by the medical ethics committees of the participating hospitals. All participants received information about the Dutch ADR Monitor prior to participation and signed a digital informed consent form.

Author contribution statement

Conception and design by J.M. Quik and N.T. Jessurun. Data analysis was executed by J.M. Quik. J.M. Quik, N.T. Jessurun, J.A. van Lint, H.R. Gosselt and L.J. Kosse worked on writing the original draft. Reviewing and editing was done by J.M. Quik, N.T. Jessurun, J.A. van Lint, H.R. Gosselt, L.J. Kosse, P.M. ten Klooster, H.E. Vonkeman and B.J.F. van den Bemt.

Data availability

The dataset analyzed during the current study is available from the corresponding author on reasonable request.

Acknowledgements

This research was presented as a poster at the 2024 European Association for Clinical Pharmacology and Therapeutics congress on 11^th June 2024.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2383707

Additional information

Funding

This paper was not funded.