Journal of Pharmacovigilance

Abstract

Position and Processing of Adverse Drug Reactions Directly Submitted by Patients to National Regulatory Authorities in Europe

Jindrich Srba and Jiri Vlcek

Introduction: Adverse drug reaction (ADR) reports submitted by patients to national regulatory authorities should be directly accepted since July 2012 when new pharmacovigilance legislation was implemented. This questionnaire based analysis and review was conducted to evaluate the position of ADR reports submitted by patients and to compare ADR reporting by patients and healthcare professionals (HPs).

Materials and Methods: Questionnaires were provided to national regulatory authorities in 2011 to evaluate their attitudes toward the ADR reports submitted directly by patients. In addition, electronic databases (2003–2011) were searched, including MEDLINE and EMBASE, and reference lists of included studies were reviewed, to compare data from ADR reports sent by patients and HPs.

Results: Of the 30 questionnaires distributed to national regulatory authorities, 17 were received back and included in this analysis. Patients were allowed to directly submit ADR reports in 12 countries. ADR reports from patients were used for signal detection in 10 countries. Medical confirmation was performed in four countries. Four comparative studies were included in systematic review. Varying outcomes were observed across the studies based on qualitative analysis.

Conclusions: Different approach in the processing of ADR reports submitted by patients among national regulatory authorities was observed. Comparison of reports submitted by patients and HPs resulted in various outcomes. Position of patient reporting was not uniform and varies from country to country. Further investigation of the processing of ADR reports would be beneficial to better understand the potential or reports submitted by patients.