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

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.