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

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

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Data availability

All data generated or analyzed during this study are included in the published article.

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Author information

Authors and Affiliations

  1. Department of Public Health, College of Health Science, Abu Dhabi University, Abu Dhabi, United Arab Emirates

    Rania Al Dweik

  2. Interdisciplinary School of Health Sciences, Faculty of Health Sciences, Director, Series on Health and Society, University of Ottawa, Ottawa, ON, Canada

    Sanni Yaya

  3. Ottawa Hospital Research Institute, Clinical Epidemiology Program, School of Nursing, Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada

    Dawn Stacey

  4. School of Epidemiology, Public Health, and Preventive Medicine, University of Ottawa, Ottawa, ON, Canada

    Dafna Kohen

Authors
  1. Rania Al Dweik
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  2. Sanni Yaya
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  3. Dawn Stacey
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  4. Dafna Kohen
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Corresponding author

Correspondence to Rania Al Dweik.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study was approved by the University of Ottawa Research Ethics Board in July 2014 (file no. H05-14-18). To ensure confidentiality, all personal identifiers were removed from transcripts and numbers were used to identify participants (e.g., P1, P2…P15). Written informed consent was obtained from all participants prior to their interview.

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Al Dweik, R., Yaya, S., Stacey, D. et al. Patients’ experiences on adverse drug reactions reporting: a qualitative study. Eur J Clin Pharmacol 76, 1723–1730 (2020). https://doi.org/10.1007/s00228-020-02958-1

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  • DOI: https://doi.org/10.1007/s00228-020-02958-1

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