Abstract：
OBJECTIVES:To determine the incidence, pattern, causality, preventability, severity and predictors of adverse drug reactions (ADRs) in pediatric population. METHODS:It was a prospective, observational study that included patients of either sex, of any age treated in the pediatric wards of a tertiary care hospital. Study patients were followed throughout their hospital stay. Whenever an ADR was detected, all the required data was collected and analyzed. Data was analyzed for incidence, causality (by using WHO Probability scale and Naranjo's algorithm), preventability (by using Modified Shumock and Thornton scale), severity (by using Modified Hartwig and Siegel scale) and predictors of ADRs. RESULTS:Of the 1775 children admitted in the pediatrics ward, 1082 patients met study criteria and were enrolled into the study. A total of 64 ADRs were identified from 54 patients. The incidence of ADRs was 4.99 %. Male patients experienced majority (68.52 %) of ADRs. Drugs most commonly implicated in ADRs were amoxicillin + clavulanate (21.87 %) followed by ceftriaxone (20.31 %). Most (51.56 %) of the ADRs reported belonged to the system organ class, gastrointestinal system disorders. Among the ADRs reported, 82.85 % of ADRs were mild. Majority (87.5 %) of the ADRs were of 'probable' causality category and 96.9 % were not preventable. There was a significant association between occurrence of ADRs and the use of ≥4 number of medications, age (infants) and gender (male). CONCLUSIONS:Among the pediatric population, infants, male gender and those receiving ≥4 number of medications are at risk of developing ADRs. Constant monitoring is required to address the safety issue in pediatric population especially in infants and patients receiving ≥4 drugs.
journal_name
Indian J Pediatrjournal_title
Indian journal of pediatricsauthors
Kurian J,Mathew J,Sowjanya K,Chaitanya KR,Ramesh M,Sebastian J,Narayanappa Ddoi
10.1007/s12098-015-2002-1subject
Has Abstractpub_date
2016-05-01 00:00:00pages
414-9issue
5eissn
0019-5456issn
0973-7693pii
10.1007/s12098-015-2002-1journal_volume
83pub_type
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章,评审
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journal_title：Indian journal of pediatrics
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journal_title：Indian journal of pediatrics
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journal_title：Indian journal of pediatrics
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doi：10.1007/s12098-014-1536-y
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章,meta分析
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journal_title：Indian journal of pediatrics
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章
doi：10.1007/BF02722298
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章
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更新日期：2000-02-01 00:00:00
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journal_title：Indian journal of pediatrics
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章,评审
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pub_type： 杂志文章,评审
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章,评审
doi：
更新日期：2000-01-01 00:00:00
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章
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pub_type： 杂志文章
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章,评审
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journal_title：Indian journal of pediatrics
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更新日期：2000-06-01 00:00:00
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journal_title：Indian journal of pediatrics
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doi：10.1007/s12098-011-0557-z
更新日期：2012-04-01 00:00:00
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doi：10.1007/s12098-014-1602-5
更新日期：2014-12-01 00:00:00
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journal_title：Indian journal of pediatrics
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doi：10.1007/s12098-007-0060-8
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章
doi：10.1007/s12098-007-0179-7
更新日期：2007-10-01 00:00:00
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journal_title：Indian journal of pediatrics
pub_type： 杂志文章
doi：10.1007/s12098-009-0020-6
更新日期：2009-03-01 00:00:00
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更新日期：2009-10-01 00:00:00
