Document Detail

Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting.
MedLine Citation:
PMID:  23027707     Owner:  NLM     Status:  Publisher    
PURPOSE: To evaluate a methodology for adverse drug reactions (ADRs) detection through hospital databases. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. Copyright © 2012 John Wiley & Sons, Ltd.
Ana Miguel; Luís Filipe Azevedo; Fernando Lopes; Alberto Freitas; Altamiro Costa Pereira
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-1
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  -     ISSN:  1099-1557     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 John Wiley & Sons, Ltd.
Centre for Research in Health Technologies and Information Systems (CINTESIS), Faculty of Medicine, Oporto University, Oporto, Portugal; Department of Ophthalmology, Hospital University Centre of Coimbra, Coimbra, Portugal.
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