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Drug Safety
Erschienen in: Drug Safety 6/2012

01.06.2012 | Original Research Article

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

A Multicentre Cohort Study

verfasst von: 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, Dr Antje Neubert

Erschienen in: Drug Safety | Ausgabe 6/2012

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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.
Literatur
1.
Lazarous J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200–5CrossRef
2.
Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality. JAMA 1997; 277: 301–6PubMedCrossRef
3.
Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004; 329: 15–9PubMedCrossRef
4.
Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52: 77–83PubMedCrossRef
5.
Kearns GL, Abdel-Rahman DM, Alander SW, et al. Developmental pharmacology: drug disposition, action, and therapy in infants and children. N Engl J Med 2003; 349(12): 1157–67PubMedCrossRef
6.
Neubert A, Dormann H, Weiss J, et al. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf 2004; 27: 1059–67PubMedCrossRef
7.
Turner S, Nunn AJ, Fielding K, et al. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 1999; 88: 965–8PubMedCrossRef
8.
Clavenna A, Bonati M. Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child 2009; 94: 724–8PubMedCrossRef
9.
Haffner S, von Laue N, Wirth S, et al. Detecting adverse drug reactions on paediatric wards: intensified surveillance versus computerised screening of laboratory values. Drug Saf 2005; 28: 453–64PubMedCrossRef
10.
Thurmann PA. Methods and systems to detect adverse drug reactions in hospitals. Drug Saf 2001; 24: 961–8PubMedCrossRef
11.
Choonara IA, Harris F. Adverse drug reactions in medical inpatients. Arch Dis Child 1984; 59: 578–80PubMedCrossRef
12.
Gill AM, Leach HJ, Hughes J, et al. Adverse drug reactions in a paediatric intensive care unit. Acta Paediatr 1995; 84: 438–41PubMedCrossRef
13.
Martinez-Mir I, Garcia-Lopez M, Palop V, et al. A prospective study of adverse drug reactions in hospitalized children. Br J Clin Pharmacol 1999; 47: 681–8PubMedCrossRef
14.
Neubert A, Dormann H, Weiss J, et al. Are computerised monitoring systems of value to improve pharmacovigilance in paediatric patients? Eur J Clin Pharmacol 2006; 62: 959–65PubMedCrossRef
15.
Gonzalez-Martin G, Caroca CM, Paris E. Adverse drug reactions (ADRs) in hospitalized pediatric patients: a prospective study. Int J Clin Pharmacol Ther 1998; 36: 530–3PubMed
16.
ADVISE (Adverse Drug Reactions in Children — International Surveillance and Evaluation) [online]. Available from URL: www.​paediatric-adr.​com [Accessed 2012 Mar 12]
17.
18.
19.
20.
Weiss J, Krebs S, Hoffmann C, et al. Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection. Pediatrics 2002; 110: 254–7PubMedCrossRef
21.
Murff HJ, Patel VL, Hripcsak G, et al. Detecting adverse events for patient safety research: a review of current methodologies. J Biomed Inform 2003; 36: 131–43PubMedCrossRef
22.
Neubert A, Rascher W. Adverse drug reactions in children: identification and evaluation. Monatsschr Kinderheilkd 2007; 155: 700–8CrossRef
23.
24.
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239–45PubMedCrossRef
25.
Dormann H, Muth-Selbach U, Kerbs S, et al. Incidence and costs of adverse drug reactions during hospitalisation: computerised monitoring versus stimulated spontaneous reporting. Drug Saf 2000; 22(2): 161–8PubMedCrossRef
26.
27.
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions [letter]. Hosp Pharm 1992; 27: 538PubMed
28.
Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33: 159–74PubMedCrossRef
29.
Neubert A, Verhamme K, Murray ML, et al. The prescribing of analgesics and non-steroidal anti-inflammatory drugs in paediatric primary care in the UK, Italy and the Netherlands. Pharmacol Res 2010; 62: 243–8PubMedCrossRef
30.
Lasky T, Ernst FR, Greenspan J, et al. Estimating pediatric inpatient medication use in the United States. Pharma-coepidemiol Drug Saf 2011; 20: 76–82CrossRef
31.
Temple ME, Robinson RF, Miller JC, et al. Frequency and preventability of adverse drug reactions in paediatric patients. Drug Saf 2004; 27: 819–29PubMedCrossRef
32.
McDonnell C. Opioid medication errors in pediatric practice: four years’ experience of voluntary safety reporting. Pain Res Manag 2011; 16(2): 93–8
33.
Jarernsiripornkul N, Krska J, Capps PA, et al. Patient reporting of potential adverse drug reactions: a methodological study. Br J Clin Pharmacol 2002; 53: 318–25PubMedCrossRef
34.
Easton KL, Parsons BJ, Starr M, et al. The incidence of drug-related problems as a cause of hospital admissions in children. Med J Aust 1998; 169: 356–9PubMed
35.
Dunn KL, Reddy P, Moulden A, et al. Medical record review of deaths, unexpected intensive care unit admissions, and clinician referrals: detection of adverse events and insight into the system. Arch Dis Child 2006; 91: 169–72PubMedCrossRef
36.
Runciman WB, Roughead EE, Semple SJ, et al. Adverse drug events and medication errors in Australia. Int J Qual Health Care 2003; 15 Suppl. 1: i49–59PubMedCrossRef
37.
Fattahi F, Pourpak Z, Moin M, et al. Adverse drug reactions in hospitalized children in a department of infectious diseases. J Clin Pharmacol 2005; 45: 1313–8PubMedCrossRef
38.
Davies EC, Green CF, Mottram DR, et al. Adverse drug reactions in hospital in-patients: a pilot study. J Clin Phar Ther 2006; 31: 335–41CrossRef
39.
Davies EC, Green CF, Taylor S, et al. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS One 2009; 4: e4439PubMedCrossRef
40.
Sanchez Munoz-Torrero JF, Barguilla P, Velasco R, et al. Adverse drug reactions in internal medicine units and associated risk factors. Eur J Clin Pharmacol 2010; 66: 1257–64PubMedCrossRef
41.
Zopf Z, Rabe C, Neubert A, et al. Women encounter ADRs more often than do men. Eur J Clin Pharmacol 2008; 64: 999–1004PubMedCrossRef
42.
Dormann H, Criegee-Rieck M, Neubert A, et al. Lack of awareness of community-acquired adverse drug reactions upon hospital admission: dimensions and consequences of a dilemma. Drug Saf 2003; 26: 353–62PubMedCrossRef
43.
van der Hooft CS, Sturkenboom MC, van Grootheest K, et al. Adverse drug reaction-related hospitalisations: a nationwide study in The Netherlands. Drug Saf 2006; 29: 161–8PubMedCrossRef
44.
Buajordet I, Wesenberg F, Brors O, et al. Adverse drug events in children during hospitalization and after discharge in a Norwegian university hospital. Acta Paediatr 2002; 91: 88–94PubMedCrossRef
45.
Clarkson A, Choonara I. Surveillance for fatal suspected adverse drug reactions in the UK. Arch Dis Child 2002; 87: 462–6PubMedCrossRef
Metadaten
Titel
Adverse Drug Reactions in Children — International Surveillance and Evaluation (ADVISE)
A Multicentre Cohort Study
verfasst von
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
Dr Antje Neubert
Publikationsdatum
01.06.2012
Verlag
Springer International Publishing
Erschienen in
Drug Safety / Ausgabe 6/2012
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI
https://doi.org/10.2165/11597920-000000000-00000

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