Drug Safety

, Volume 37, Issue 6, pp 409–419 | Cite as

Adverse Drug Reaction Reporting by Patients: An Overview of Fifty Countries

  • Florence Margraff
  • Delphine BertramEmail author
Original Research Article



The modalities and contributions to drug safety of patient adverse drug reaction reporting systems in 50 countries have been reviewed and analysed.


The means made available by National Health Competent Authorities (NCAs) for patients to report drug side effects were compared through literature review and questionnaire.


Among the 50 countries included in this study, we found that direct patient reporting systems exist in 44 countries and represent 9 % of total reports, the rest coming from healthcare professionals. Australia was the first, in 1964, and the United States has the system in which patients are the most involved. A total of 27 countries have a patient-specific reporting form, and 31 countries provide a form to complete online. In order to help patients, four countries constrain the description of the reaction and 12 constrain the choice of drug on the reporting form. Most of the surveyed countries request the patient’s medical history (30 countries) and concomitant therapies (41 countries). The total number of fields per form ranges from 6 to 59, with a mean of 36 items.


Most of the surveyed countries have implemented a patient adverse drug reaction reporting system. From this study, it seems that an online reporting form increases the rate of reporting. Currently, many different forms exist worldwide; these should be harmonized by considering the strengths and weaknesses of all existing forms. But above all, to increase the number of reports, each country should promote NCA-initiated adverse drug reactions reporting systems.


Healthcare Professional Adverse Drug Reaction Varenicline Adverse Drug Reaction Reporting International Drug Monitoring 
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.


Funding and conflicts of interest

No sources of funding were used to assist in the preparation of this study. Florence Margraff and Delphine Bertram have no conflicts of interest that are directly relevant to the content of this study.

Supplementary material

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Supplementary material 1 (DOC 26 kb)
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Supplementary material 2 (XLS 38 kb)
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Supplementary material 3 (XLS 39 kb)
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Supplementary material 4 (XLS 38 kb)


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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  1. 1.Délégation à la Recherche Clinique et à l’InnovationHospices Civils de LyonLyon Cedex 02France

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