Drug Safety

, Volume 35, Issue 1, pp 45–60 | Cite as

Experiences with Adverse Drug Reaction Reporting by Patients

An 11-Country Survey
  • Florence van HunselEmail author
  • Linda Härmark
  • Shanthi Pal
  • Sten Olsson
  • Kees van Grootheest
Original Research Article


Background: Patients are important stakeholders in pharmacovigilance; however, little formal evaluation has been undertaken of existing patient reporting schemes within and outside Europe. If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted.

Objective: This study aims to review the methods of patient reporting of adverse drug reactions (ADRs) in 11 countries worldwide and to compare different aspects of their experiences.

Methods: A survey based on telephone interviews, e-mail discussions and field visits of existing practices in consumer and patient reporting of ADRs was performed in the second half of 2010.

Results: The start dates of the patient reporting schemes vary from 1964 (Australia) to 2010 (Norway). The number of patient reports per country varies widely. Most countries would ideally spend more resources on making the public aware of the possibility that patients can report ADRs.


Patient Reporting Adverse Drug Reaction Report Reporting Scheme Suspected Adverse Drug Reaction Therapeutic Good Administration 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors are indebted to all the National Pharmacovigilance Centre representatives and the AME Line who participated in this study.

This study was performed as part of the ‘Monitoring Medicines’ project, which is funded by the Seventh Framework Programme (FP-7) of the Research Directorate of the European Commission [grant 223566].


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Copyright information

© Adis Data Information BV 2012

Authors and Affiliations

  • Florence van Hunsel
    • 1
    • 2
    Email author
  • Linda Härmark
    • 1
    • 2
  • Shanthi Pal
    • 3
  • Sten Olsson
    • 4
  • Kees van Grootheest
    • 1
    • 2
  1. 1.Netherlands Pharmacovigilance Centre Lareb’s-Hertogenboschthe Netherlands
  2. 2.Department of Pharmacy, Pharmacotherapy and Pharmaceutical CareUniversity of GroningenGroningenthe Netherlands
  3. 3.Quality Assurance and Safety of Medicines, World Health OrganizationGenevaSwitzerland
  4. 4.World Health Organization Collaborating Centre for International Drug MonitoringUppsalaSweden

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