Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a multicentre cohort study

Asia N Rashed; Ian C K Wong; Noel Cranswick; Barbara Hefele; Stephen Tomlin; John Jackman; Kenneth Lee; Kam-Lun E Hon; Jeffrey Ong; Maisoon Ghaleb; Siew Siang Chua; Tea Ming Hui; Wolfgang Rascher; Antje Neubert

doi:10.2165/11597920-000000000-00000

Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a multicentre cohort study

Asia N Rashed, Ian C K Wong, Noel Cranswick, Barbara Hefele, Stephen Tomlin, John Jackman, Kenneth Lee, Kam-Lun E Hon, Jeffrey Ong, Maisoon Ghaleb, Siew Siang Chua, Tea Ming Hui, Wolfgang Rascher, Antje Neubert^*

^*Corresponding author for this work

Institute of Pharmaceutical Science

Research output: Contribution to journal › Article › peer-review

40 Citations (Scopus)

Abstract

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 the UK 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) and median length of hospital stay was 4 days (IQR 3-7). A total 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 in Malaysia 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.

Original language	English
Pages (from-to)	481-94
Number of pages	14
Journal	Drug Safety
Volume	35
Issue number	6
DOIs	https://doi.org/10.2165/11597920-000000000-00000
Publication status	Published - 1 Jun 2012

Keywords

Adolescent
Adverse Drug Reaction Reporting Systems
Asia
Australia
Child
Child, Preschool
Cohort Studies
Drug-Related Side Effects and Adverse Reactions
Europe
Female
Hospitalization
Humans
Incidence
Infant
Length of Stay
Male
Prospective Studies

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10.2165/11597920-000000000-00000

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Rashed, A. N., Wong, I. C. K., Cranswick, N., Hefele, B., Tomlin, S., Jackman, J., Lee, K., Hon, K.-L. E., Ong, J., Ghaleb, M., Chua, S. S., Hui, T. M., Rascher, W., & Neubert, A. (2012). Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a multicentre cohort study. Drug Safety, 35(6), 481-94. https://doi.org/10.2165/11597920-000000000-00000

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abstract = "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 the UK 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) and median length of hospital stay was 4 days (IQR 3-7). A total 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 in Malaysia 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.",

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author = "Rashed, {Asia N} and Wong, {Ian C K} and Noel Cranswick and Barbara Hefele and Stephen Tomlin and John Jackman and Kenneth Lee and Hon, {Kam-Lun E} and Jeffrey Ong and Maisoon Ghaleb and Chua, {Siew Siang} and Hui, {Tea Ming} and Wolfgang Rascher and Antje Neubert",

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doi = "10.2165/11597920-000000000-00000",

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pages = "481--94",

journal = "Drug Safety",

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T1 - Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE)

T2 - a multicentre cohort study

AU - Rashed, Asia N

AU - Wong, Ian C K

AU - Cranswick, Noel

AU - Hefele, Barbara

AU - Tomlin, Stephen

AU - Jackman, John

AU - Lee, Kenneth

AU - Hon, Kam-Lun E

AU - Ong, Jeffrey

AU - Ghaleb, Maisoon

AU - Chua, Siew Siang

AU - Hui, Tea Ming

AU - Rascher, Wolfgang

AU - Neubert, Antje

PY - 2012/6/1

Y1 - 2012/6/1

N2 - 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 the UK 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) and median length of hospital stay was 4 days (IQR 3-7). A total 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 in Malaysia 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.

AB - 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 the UK 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) and median length of hospital stay was 4 days (IQR 3-7). A total 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 in Malaysia 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.

KW - Adolescent

KW - Adverse Drug Reaction Reporting Systems

KW - Asia

KW - Australia

KW - Child

KW - Child, Preschool

KW - Cohort Studies

KW - Drug-Related Side Effects and Adverse Reactions

KW - Europe

KW - Female

KW - Hospitalization

KW - Humans

KW - Incidence

KW - Infant

KW - Length of Stay

KW - Male

KW - Prospective Studies

U2 - 10.2165/11597920-000000000-00000

DO - 10.2165/11597920-000000000-00000

M3 - Article

C2 - 22612852

SN - 0114-5916

VL - 35

SP - 481

EP - 494

JO - Drug Safety

JF - Drug Safety

IS - 6

ER -

Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a multicentre cohort study

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Keywords

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