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Article: Adverse drug reactions in children international surveillance and evaluation (ADVISE): A multicentre cohort study

TitleAdverse drug reactions in children international surveillance and evaluation (ADVISE): A multicentre cohort study
Authors
Issue Date2012
PublisherAdis International Ltd. The Journal's web site is located at http://drugsafety.adisonline.com/
Citation
Drug Safety, 2012, v. 35 n. 6, p. 481-494 How to Cite?
AbstractBackground: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied. Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries. Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia,Germany,Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs. Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and theUK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) andmedian length of hospital staywas 4 days (IQR 3-7).Atotal of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95%CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed inMalaysia and the UK. 65.3%(n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal. Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied. Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries. Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia,Germany,Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs. Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and theUK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) andmedian length of hospital staywas 4 days (IQR 3-7).Atotal of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95%CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed inMalaysia and the UK. 65.3%(n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal.Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied. Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries. Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia,Germany,Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs. Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and theUK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) andmedian length of hospital staywas 4 days (IQR 3-7).Atotal of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95%CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed inMalaysia and the UK. 65.3%(n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal. Conclusions: By comparing data from five countries in Europe, Asia and Australia we have shown that the incidence of ADRs in hospitalized children is at least as high as incidences published in adults. However, the variation between countries was mainly due to different populations and treatment strategies. Particular attention should be given to opioid use in hospitalized children. © 2012 Springer International Publishing AG. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/171441
ISSN
2015 Impact Factor: 3.206
2015 SCImago Journal Rankings: 1.359
References

 

DC FieldValueLanguage
dc.contributor.authorRashed, ANen_US
dc.contributor.authorWong, ICKen_US
dc.contributor.authorCranswick, Nen_US
dc.contributor.authorHefele, Ben_US
dc.contributor.authorTomlin, Sen_US
dc.contributor.authorJackman, Jen_US
dc.contributor.authorLee, Ken_US
dc.contributor.authorHon, KLEen_US
dc.contributor.authorOng, Jen_US
dc.contributor.authorGhaleb, Men_US
dc.contributor.authorChua, SSen_US
dc.contributor.authorHui, TMen_US
dc.contributor.authorRascher, Wen_US
dc.contributor.authorNeubert, Aen_US
dc.date.accessioned2012-10-30T06:14:15Z-
dc.date.available2012-10-30T06:14:15Z-
dc.date.issued2012en_US
dc.identifier.citationDrug Safety, 2012, v. 35 n. 6, p. 481-494en_US
dc.identifier.issn0114-5916en_US
dc.identifier.urihttp://hdl.handle.net/10722/171441-
dc.description.abstractBackground: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied. Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries. Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia,Germany,Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs. Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and theUK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) andmedian length of hospital staywas 4 days (IQR 3-7).Atotal of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95%CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed inMalaysia and the UK. 65.3%(n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal. Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied. Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries. Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia,Germany,Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs. Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and theUK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) andmedian length of hospital staywas 4 days (IQR 3-7).Atotal of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95%CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed inMalaysia and the UK. 65.3%(n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal.Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied. Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries. Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia,Germany,Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs. Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and theUK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) andmedian length of hospital staywas 4 days (IQR 3-7).Atotal of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95%CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed inMalaysia and the UK. 65.3%(n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal. Conclusions: By comparing data from five countries in Europe, Asia and Australia we have shown that the incidence of ADRs in hospitalized children is at least as high as incidences published in adults. However, the variation between countries was mainly due to different populations and treatment strategies. Particular attention should be given to opioid use in hospitalized children. © 2012 Springer International Publishing AG. All rights reserved.en_US
dc.languageengen_US
dc.publisherAdis International Ltd. The Journal's web site is located at http://drugsafety.adisonline.com/en_US
dc.relation.ispartofDrug Safetyen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdverse Drug Reaction Reporting Systems - Statistics & Numerical Dataen_US
dc.subject.meshAsiaen_US
dc.subject.meshAustraliaen_US
dc.subject.meshChilden_US
dc.subject.meshChild, Preschoolen_US
dc.subject.meshCohort Studiesen_US
dc.subject.meshEuropeen_US
dc.subject.meshFemaleen_US
dc.subject.meshHospitalization - Statistics & Numerical Dataen_US
dc.subject.meshHumansen_US
dc.subject.meshIncidenceen_US
dc.subject.meshInfanten_US
dc.subject.meshLength Of Stayen_US
dc.subject.meshMaleen_US
dc.subject.meshPharmaceutical Preparations - Adverse Effectsen_US
dc.subject.meshProspective Studiesen_US
dc.titleAdverse drug reactions in children international surveillance and evaluation (ADVISE): A multicentre cohort studyen_US
dc.typeArticleen_US
dc.identifier.emailWong, ICK:wongick@hku.hken_US
dc.identifier.authorityWong, ICK=rp01480en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.2165/11597920-000000000-00000en_US
dc.identifier.pmid22612852-
dc.identifier.scopuseid_2-s2.0-84861361709en_US
dc.identifier.hkuros207157-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84861361709&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume35en_US
dc.identifier.issue6en_US
dc.identifier.spage481en_US
dc.identifier.epage494en_US
dc.publisher.placeNew Zealanden_US
dc.identifier.scopusauthoridRashed, AN=54584268300en_US
dc.identifier.scopusauthoridWong, ICK=7102513915en_US
dc.identifier.scopusauthoridCranswick, N=6601977827en_US
dc.identifier.scopusauthoridHefele, B=6507477180en_US
dc.identifier.scopusauthoridTomlin, S=7003861490en_US
dc.identifier.scopusauthoridJackman, J=55226709400en_US
dc.identifier.scopusauthoridLee, K=55226715700en_US
dc.identifier.scopusauthoridHon, KLE=55077057100en_US
dc.identifier.scopusauthoridOng, J=55226063100en_US
dc.identifier.scopusauthoridGhaleb, M=8903103000en_US
dc.identifier.scopusauthoridChua, SS=9841352700en_US
dc.identifier.scopusauthoridHui, TM=55226624500en_US
dc.identifier.scopusauthoridRascher, W=7102158639en_US
dc.identifier.scopusauthoridNeubert, A=7003774960en_US

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