Florence van Hunsel1, Susan de Waal1,2, Linda Härmark1. 1. Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre For Pharmacovigilance In Education And Patient Reporting, 's-Hertogenbosch, The Netherlands. 2. Pharmaceutical Business Administration, Institute for Allied Healthcare, Utrecht University of Applied Sciences, Utrecht, the Netherlands.
Abstract
PURPOSE: The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. METHOD: All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports. In addition to source, the analysis included ATC code of the drug, MedDRA® system organ class and preferred term for the adverse drug reaction (ADR), seriousness of the ADR, and 7 other factors like reports on over-the-counter medication, and how often an ADR listed in the important medical event terms list was present. Secondly, we determined the proportion of reports submitted by the individual groups to signals, in a cross-sectional manner. RESULTS: A total of 150 signals were included, including 1691 ADR reports. Our results show that 26.3% of all ADR reports in Dutch drug safety signals were reported by patients, and 30.5% of the patient reports in the signals contained one or more terms listed as important medical events. The proportion of reports by patients which were included the signals was 2% and 3.9% for health care professional reports and 0.2% for marketing authorization holders reports. CONCLUSION: Patients had an important contribution to signals overall, but especially for ADRs related to generic drug substitution and psychiatric ADRs.
PURPOSE: The purpose of this study was to investigate the contribution of patient reports to signals sent by the Netherlands Pharmacovigilance Centre Lareb to the Dutch Medicines Evaluation Board and to determine if there are certain types of signals where patient report add a distinct contribution. METHOD: All signals from 2010 until 2015 were included. First, we investigated how many patient reports were present in the signals and the characteristics of these reports compared to the health care professional and marketing authorization holders' reports. In addition to source, the analysis included ATC code of the drug, MedDRA® system organ class and preferred term for the adverse drug reaction (ADR), seriousness of the ADR, and 7 other factors like reports on over-the-counter medication, and how often an ADR listed in the important medical event terms list was present. Secondly, we determined the proportion of reports submitted by the individual groups to signals, in a cross-sectional manner. RESULTS: A total of 150 signals were included, including 1691 ADR reports. Our results show that 26.3% of all ADR reports in Dutch drug safety signals were reported by patients, and 30.5% of the patient reports in the signals contained one or more terms listed as important medical events. The proportion of reports by patients which were included the signals was 2% and 3.9% for health care professional reports and 0.2% for marketing authorization holders reports. CONCLUSION:Patients had an important contribution to signals overall, but especially for ADRs related to generic drug substitution and psychiatric ADRs.
Authors: Joep H G Scholl; Florence P A M van Hunsel; Eelko Hak; Eugène P van Puijenbroek Journal: Pharmacoepidemiol Drug Saf Date: 2017-12-21 Impact factor: 2.890
Authors: Sarah Watson; Rebecca E Chandler; Henric Taavola; Linda Härmark; Birgitta Grundmark; Alem Zekarias; Kristina Star; Florence van Hunsel Journal: Drug Saf Date: 2018-02 Impact factor: 5.606
Authors: Kamila Sienkiewicz; Monika Burzyńska; Izabela Rydlewska-Liszkowska; Jacek Sienkiewicz; Ewelina Gaszyńska Journal: Int J Environ Res Public Health Date: 2021-12-31 Impact factor: 3.390