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The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015
Author(s) -
Hunsel Florence,
Waal Susan,
Härmark Linda
Publication year - 2017
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.4236
Subject(s) - pharmacovigilance , medicine , seriousness , drug , family medicine , meddra , patient safety , pharmacoepidemiology , adverse drug reaction , marketing authorization , drug class , authorization , adverse drug event , biosimilar , postmarketing surveillance , health care , medical emergency , adverse effect , pharmacology , bioinformatics , computer security , political science , medical prescription , computer science , law , economics , biology , economic growth
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.