Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting

Pharmacoepidemiology and Drug Safety
Ana MiguelAltamiro Costa Pereira

Abstract

To evaluate a methodology for adverse drug reactions (ADRs) detection through hospital databases. A retrospective analysis was conducted to identify ADRs using diagnostic codes from databases, later validated by chart review. An independent chart review was performed for comparison, as well as assessment of spontaneous reports. 325 ADRs were identified (prevalence of 2.41%, positive predictive value of 87.6%). Independent chart review identified 9% of ADRs at a cost of 35 person-hours (versus two person-hours in databases). There were seven spontaneous reports of ADRs. Although not frequently used, the detection of ADRs through databases is a relatively less expensive, fast and effective methodology that can improve current pharmacovigilance systems.

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Citations

Oct 12, 2014·European Journal of Clinical Pharmacology·G DurrieuJ L Montastruc
Sep 16, 2015·The Journal of Allergy and Clinical Immunology. in Practice·Rebecca R SaffAleena Banerji
Jun 14, 2013·Pharmacoepidemiology and Drug Safety·Ana MiguelAltamiro Costa Pereira
Mar 24, 2016·Journal of the American Geriatrics Society·Karen L PellegrinR Scott Holuby
Jan 26, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Tim SchutteMichiel van Agtmael
Jan 28, 2018·Journal of Medical Systems·Bernardo Sousa-PintoAlberto Freitas

Related Concepts

Hospitals
Retrospective Studies
Adverse Drug Reaction Reporting Systems
Pharmacoepidemiology
Retrospective Studies
Adverse Reaction to Drug
Evaluation

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