Abstract
Background: Adverse drug events (ADEs) are an important problem in all hospitalized patients as these events represent medication-related patient harm. Few epidemiologic data exist regarding ADEs in the pediatric inpatient setting and, in particular, the economic impact of such ADEs upon the healthcare sector.
Objective: To evaluate the incidence, preventability, and seriousness of ADEs and potential ADEs occurring in hospitalized children and to examine the cost implications of these ADEs.
Methods: This was a prospective observational cohort study conducted in the pediatric, neonatal intensive care unit (NICU), and postnatal wards of a university-affiliated urban general hospital in Dunedin, New Zealand (NZ). The study population was all patients admitted to these wards for >24 hours over a 12-week period from 18 March 2002 to 9 June 2002. Medication-related events were identified by chart review, attendance at multidisciplinary clinical meetings, parent/carer/child interviews, and voluntary and verbally solicited reports from staff. All suspected medication-related events were reviewed by a panel of three health professionals who independently categorized the events and rated them for seriousness, preventability, and causality, using a standardized reviewer form. Costs attributable to ADEs were calculated using both the average cost of a bed day, and specific costs for diagnostic groupings. The main outcome measures of the study were ADEs and potential ADEs.
Results: There were 495 eligible study patients, who had a total of 520 admissions and 3037 patient-days of admission, during which 3160 prescription episodes were written. There were 67 ADEs, of which 38 (56.7%) were classified as preventable, and 77 potential ADEs. ADEs occurred at a rate of 2.1 per 100 prescription episodes, 12.9 per 100 admissions, and 22.1 per 1000 patient-days. Potential ADEs occurred at a rate of 2.4 per 100 prescription episodes, 14.6 per 100 admissions, and 25 per 1000 patient-days. Although the greatest number (and rate per 100 admissions) of ADEs occurred in NICU patients, surgical pediatric ward patients had the greatest rate of ADEs per 1000 patient-days. Few events occurred in postnatal patients. Forty-six percent of ADEs were classified as being serious; 15% were deemed to result in persistent disability or were classified as life threatening. Potential ADEs were deemed more likely to be serious with 82% classified as potentially serious events; 33% were deemed as having the potential to result in persistent disability, or the potential to cause a life-threatening event. Fifteen ADEs were judged to have caused the hospital admission or to have prolonged hospital stay. The total number of days attributed to ADEs was 92 (range 1–26 days); of these, 58 were deemed preventable days and 34 non-preventable days. This extrapolates to a total annual cost of $NZ235 214 (2002 values) to the pediatric service, subdivided into $NZ148 287 for preventable ADEs and $NZ86927 for non-preventable ADEs.
Conclusion: ADEs and potential ADEs represent a considerable hazard for the pediatric inpatient population and ADEs represent a large cost imposition upon the healthcare sector. Over half of the ADEs were deemed preventable. This highlights the importance of developing strategies to prevent and ameliorate ADEs both to improve the quality of patient care and to reduce healthcare costs.
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References
Ghaleb MA, Barber N, Franklin BD, et al. Systematic review of medication errors in pediatric patients. Ann Pharmacother 2006 Oct; 40(10): 1766–76
Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001; 285(16): 2114–20
Holdsworth MT, Fichtl RE, Behta M, et al. Incidence and impact of adverse drug events in pediatric inpatients. Arch Pediatr Adolesc Med 2003 Jan; 157(1): 60–5
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(1): 88–94
Takata GS, Mason W, Tazetomo C, et al. Development, testing and findings of a pediatric focused trigger tool to identify medication-related harm in US children’s hospitals. Pediatrics 2008; 121(4): e927–35
Morimoto T, Gandhi TK, Seger AC, et al. Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care 2004 Aug; 13(4): 306–14
Kaushal R, Jaggi T, Walsh K, et al. Pediatric medication errors: what do we know? What gaps remain? Ambul Pediatr 2004 Jan–Feb; 4(1): 73–81
Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients: Adverse Drug Events Prevention Study Group. JAMA 1997; 277(4): 307–11
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 Jan 22–29; 277(4): 301–6
Senst BL, Achusim LE, Genest RP, et al. Practical approach to determining costs and frequency of adverse drug events in a health care network. Am J Health Syst Pharm 2001 Jun 15; 58(12): 1126–32
Kaushal R. Using chart review to screen for medication errors and adverse drug events. Am J Health Syst Pharm 2002; 59(23): 2323–5
Kunac DL, Reith DM, Kennedy J, et al. Inter- and intra-rater reliability for classification of medication related events in paediatric inpatients. Qual Saf Health Care 2006 Jun; 15(3): 196–201
Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med 1993; 8(6): 289–94
ICH Steering Committee, ICH Harmonised Tripartite Guideline. Clinical safety data management: definitions and standards for expedited reporting [online]. Available from URL: http://www.ich.org/LOB/media/MEDIA436.pdf. [Accessed 2008 Dec 2]
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992; 27(6): 538
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239–45
Fontan JE, Maneglier V, Nguyen VX, et al. Medication errors in hospitals: computerized unit dose drug dispensing system versus ward stock distribution system. Pharm World Sci 2003 Jun; 25(3): 112–7
Fortescue EB, Kaushal R, Landrigan CP, et al. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients. Pediatrics 2003 Apr; 111 (4 Pt 1): 722–9
King WJ, Paice N, Rangrej J, et al. The effect of computerized physician order entry on medication errors and adverse drug events in pediatric inpatients. Pediatrics 2003 Sep; 112 (3 Pt 1): 506–9
Potts AL, Barr FE, Gregory DF, et al. Computerized physician order entry and medication errors in a pediatric critical care unit. Pediatrics 2004 Jan; 113 (1 Pt 1): 59–63
Stucky ER. Prevention of medication errors in the pediatric inpatient setting. Pediatrics 2003 Aug; 112(2): 431–6
Institute for Safe Medication Practices. ISMP’s list of high-alert medications: ISMP USA [online]. Available from URL: http://www.ismp.org/Tools/highalertmedications.pdf. [Accessed 2008 Dec 2]
Holdsworth MT, Fichtl RE, Raisch DW, et al. Impact of computerized prescriber order entry on the incidence of adverse drug events in pediatric inpatients. Pediatrics 2007 Nov; 120(5): 1058–66
Classen DC, Pestotnik SL, Evans RS, et al. Computerized surveillance of adverse drug events in hospital patients. JAMA 1991; 266(20): 2847–51
Kunac DL, Reith DM. Identification of priorities for medication safety in neonatal intensive care. Drug Saf 2005; 28(3): 251–61
Acknowledgements
The authors acknowledge the contribution of the children and parents who participated in the study, the staff of the pediatric wards and pharmacy department involved in the study, Alison Davies for pharmacoeconomic advice, and the Child Health Research Foundation (CHRF) of New Zealand for financial support by way of a research fellowship awarded to Desireé Kunac.
This work was undertaken independent of the funding provided by CHRF. The CHRF had no involvement in the study design; in the collection, analysis, or interpretation of data; in the writing of the report; or in the decision to submit the paper for publication. The authors have no conflicts of interest that are directly relevant to the content of this study.
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Kunac, D.L., Kennedy, J., Austin, N. et al. Incidence, Preventability, and Impact of Adverse Drug Events (ADEs) and Potential ADEs in Hospitalized Children in New Zealand. Pediatr-Drugs 11, 153–160 (2009). https://doi.org/10.2165/00148581-200911020-00005
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DOI: https://doi.org/10.2165/00148581-200911020-00005