Experiences with Adverse Drug Reaction Reporting by Patients
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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.
KeywordsPatient Reporting Adverse Drug Reaction Report Reporting Scheme Suspected Adverse Drug Reaction Therapeutic Good Administration
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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