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

Title
Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting
Type
Another Publication in an International Scientific Journal
Year
2013
Authors
Miguel, A
(Author)
Other
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Azevedo L
(Author)
FMUP
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Lopes, F
(Author)
Other
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Freitas A
(Author)
FMUP
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Journal
Vol. 22 No. 1
Pages: 98-102
ISSN: 1053-8569
Publisher: Wiley-Blackwell
Other information
Authenticus ID: P-002-1HW
Abstract (EN): 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 (C) 2012 John Wiley & Sons, Ltd.
Language: English
Type (Professor's evaluation): Scientific
No. of pages: 5
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