A Feasibility Study of Drug-Drug Interaction Signal Detection in Regular Pharmacovigilance.

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Sara HultG Niklas Norén

Abstract

Adverse drug reactions related to drug-drug interactions cause harm to patients. There is a body of research on signal detection for drug interactions in collections of individual case reports, but limited use in regular pharmacovigilance. The aim of this study was to evaluate the feasibility of signal detection of drug-drug interactions in collections of individual case reports of suspected adverse drug reactions. This study was conducted in VigiBase, the WHO global database of individual case safety reports. The data lock point was 31 August 2016, which provided 13.6 million reports for analysis after deduplication. Statistical signal detection was performed using a previously developed predictive model for possible drug interactions. The model accounts for an interaction disproportionality measure, expressed suspicion of an interaction by the reporter, potential for interaction through cytochrome P450 activity of drugs, and reported information indicative of unexpected therapeutic response or altered therapeutic effect. Triage filters focused the preliminary signal assessment on combinations relating to serious adverse events with case series of no more than 30 reports from at least two countries, with at least one report du...Continue Reading

References

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Software Mentioned

vigiRank
DailyMed
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