Adverse drug events in hospitalized children at Ethiopian University Hospital: a prospective observational study

BMC Pediatrics

Tsinuel Girma¹  Alemayehu Berhane Mekonnen²  Getahun Paulos³  Negussu Mekonnen⁵  Bisrat Hailemeskel⁴  Tesfahun Chanie Eshetie³ 

[1]Department of Pediatrics and Child Health, College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia

[2]School of Pharmacy, Clinical Pharmacy Unit, University of Gondar, Gondar, Ethiopia

[3]School of Pharmacy, College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia

[4]College of Pharmacy, Howard University, 2300 4th Street, N.W, Washington 20059, DC, USA

[5]Management Sciences for Health - Ethiopia, Addis Ababa, Code 1250, Ethiopia

关键词: Risk factors;    Incidence;    Hospitalized children;    Ethiopia;    Adverse drug events;   

Others  :  1219307
DOI  :  10.1186/s12887-015-0401-0

 received in 2015-01-14, accepted in 2015-07-06,  发布年份 2015

【 摘 要 】

Background

The nature and magnitude of adverse drug events (ADEs) among hospitalized children in low-income countries is not well described. The aim of this study was thus, to assess the incidence and nature of ADEs in hospitalized children at a teaching hospital in Ethiopia.

Methods

We used prospective observational method to study children that were hospitalized to Jimma University Specialized Hospital between 1 February and 1 May 2011. ADEs were identified using review of treatment charts, interview of patient and care-giver, attendance at ward rounds and/or meetings and voluntary staff reports. Two senior pediatric residents evaluated the severity and preventability of ADEs using preset criteria. Logistic regression analysis was employed to determine predictors of ADEs.

Results

There were 634 admissions with 6182 patient-days of hospital stay. There were 2072 written medication orders accounting for 35,117 medication doses. Fifty eight ADEs were identified with an incidence of 9.2 per 100 admissions, 1.7 per 1000 medication doses and 9.4 per 1000 patient-days. One-third of ADEs were preventable; 47 % of these were due to errors in the administration stage of medication use process. Regarding the severity of ADEs, 91 % caused temporary harms and 9 % resulted in permanent harm/death. Anti-infective drugs were the most common medications associated with ADEs. The occurrence of ADEs increased with age, length of hospital stay, and use of CNS, endocrine and antihistamine medicines.

Conclusion

ADEs are common in hospitalized children in low-income settings; however, one-third deemed preventable. A strategy to prevent the occurrence and consequences of ADEs including education of nurses/physicians is of paramount importance.

【 授权许可】

   
2015 Eshetie et al.

【 图 表 】

Fig. 1.

【 参考文献 】

• [1]Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG et al.. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. NEJM. 1991; 324:370-376.
• [2]Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA et al.. The nature of adverse events in hospitalized patients: Results of the Harvard Medical Practice Study II. NEJM. 1991; 324:377-384.
• [3]To Err Is Human: Building A Safer Health System. National Academies Press, Washington, DC; 1999.
• [4]Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F et al.. Medication errors and adverse drug events in pediatric inpatients. JAM. 2001; 285(16):2114-2120.
• [5]Buck ML. Adverse drug events in children: Recent cases from the medical literature. Pediatr Pharm. 2010;16(9).
• [6]Ghaleb MA, Barber N, Franklin BD, Wong IC. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Arch Dis Child. 2010; 95:113-118.
• [7]Takata GS, Mason W, Taketomo C, Logsdon T, Sharek PJ. Development, testing, and findings of a pediatric-focused trigger tool to identify medication-related harm in US children’s hospitals. Pediatrics. 2008; 121(4):e297-35.
• [8]Long AL, Horvath MM, Cozart H, Eckstrand J, Whitehurst J, Ferranti J. Tailoring adverse drug event surveillance to the paediatric inpatient. Qual Saf Health Care. 2010; 19:1-5.
• [9]Kunac DL, Kennedy J, Austin N, Reith D. Incidence, preventability, and impact of adverse drug events (ADEs) and potential ADEs in hospitalized children in New Zealand. Pediatr Drugs. 2009; 11(2):153-160.
• [10]Buajordet I, Wesenberg F, Brørs O, Langslet A. Adverse drug events in children during hospitalization and after discharge in a Norwegian University Hospital. Acta Paediatr. 2002; 91:88-94.
• [11]Rodriguez-Monguio R, Otero M, Rovira J. Assessing the economic impact of adverse drug effects. Pharmacoeconomics. 2003; 21(9):623-650.
• [12]Clavenna A, Bonati M. Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child. 2009; 94:724-728.
• [13]Dos Santos DB, Coelho HL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiol Drug Saf. 2006; 15:635-640.
• [14]Martinez-Mir I, Garcia-Lopez M, Palop V, Ferrer JM, Rubio E, Morales-Olivas FJ. A prospective study of adverse drug reactions in hospitalized children. Br J Clin Pharmacol. 1999; 47:681-688.
• [15]Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. 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(1):77-83.
• [16]Silas R, Tibballs J. Adverse events and comparison of systematic and voluntary reporting from a paediatric intensive care unit. Qual Saf Health Care. 2010; 19:568-571.
• [17]Ferranti JM, Horvath MM, Cozart H. Reevaluating the safety profile of pediatrics: a comparison of computerized adverse drug event surveillance and voluntary reporting in the pediatric environment. Pediatrics. 2008; 121(5):1201-1207.
• [18]Weiss J, Krebs S, Hoffmann C, Werner U, Neubert A, Brune K et al.. Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection. Pediatrics. 2002; 110:254-257.
• [19]Sharek PJ, Horbar JD, Mason W. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-Focused Trigger Tool to identify harm in North American Nicus. Pediatrics. 2006; 118:1332-1340.
• [20]Kilbridge PM, Noirot LA, Reichley RM, Berchelmann KM, Schneider C, Heard KM et al.. Computerized surveillance for adverse drug events in a pediatric hospital. J Am Med Inform Assoc. 2009; 16(5):607-612.
• [21]Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA. 1991; 266:2847-2851.
• [22]Cohen MM, Kimmel NL, Benage MK, Cox MJ, Sanders N, Spence D et al.. Medication safety program reduces adverse drug events in a community hospital. Qual Saf Health Care. 2005; 14:169-174.
• [23]Field TS, Gurwitz JH, Harrold LR, Rothschild JM, Debellis K, Seger AC et al.. Strategies for detecting adverse drug events among older persons in the ambulatory setting. J Am Med Inform Assoc. 2004; 11:492-498.
• [24]Gardner RM, Evans RS. Using computer technology to detect, measure, and prevent adverse drug events. J Am Med Inform Assoc. 2004; 11:535-536.
• [25]Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality. JAMA. 1997; 277(4):301-306.
• [26]Evans RS, Classen DC, Stevens LE, Pestotnik SL, Gardner RM, Lloyd JF, et al. Using a hospital information system to assess the effects of adverse drug events. Proc Annu Symp Comput Appl Med Care. 1993;161–165.
• [27]Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA et al.. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA. 1997; 277(4):307-311.
• [28]Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics. 2002; 110(5): Article ID e53
• [29]Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Bates DW. Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care. 2004; 13:306-314.
• [30]Suh DC, Woodall BS, Shin SK, Hermes-De Santis ER. Clinical and economic impact of adverse drug reactions in hospitalized patients. Anna Pharmacother. 2000; 34(12):1373-379.
• [31]Jonville-Bera AP, Giraudeau B, Blanc P, Salinas FB, Autret-Leca E. Frequency of adverse drug reaction in children: a prospective study. Br J Clin Pharmacol. 2002; 53(2):207-210.
• [32]Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr. 1999; 88:965-968.
• [33]Zed PJ, Black KJ, Fitzpatrick EA, Ackroyd-Stolarz S, Murphy NG, Curran JA et al.. Medication-related emergency department visits in pediatrics: a prospective observational study. Pediatrics. 2015; 135(3):435-443.
• [34]Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D et al.. Incidence of adverse drug events and potential adverse drug events: Implications for Prevention. JAMA. 1995; 274(1):29-34.
• [35]Institute for Health Care Improvement. Trigger tool for measuring adverse drug events. Available at: http://www.ihi.org/IHI/Topics/PatientSafety/MedicationSystems/Tools/Pediatric+ADE+Patient+Record+Review+Sheet+(IHI + Tool).htm. Accessed: 30/12/2013.
• [36]Child Health Corporation of America. Pediatric trigger toolkit: Measuring adverse drug events in the Children’s Hospital. May 2007. Available at: http://www.chca.com/triggers/docs/ADE%20Trigger%20Toolkit%202007.pdf. Accessed 30/12/2013
• [37]Food, Medicine and Health care administration and control authority. List of medicines for Ethiopia, 6th edition, Sept 2010, Addis Ababa. Available at: http://www.fmhaca.gov.et/documents/MedicineForEthiopia_NDL.pdf. Accessed 25/03/2015.
• [38]The use of the WHO–UMC system for standardized case causality assessment. Available at: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf (Accessed: 30/12/2014).
• [39]National Coordinating Council for Medication Error Reporting and Prevention. Taxonomy and index category of medication errors. Available At: www.nccmerp.org. Accessed: 30/12/2013
• [40]Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992; 27:538-539.
• [41]Holdsworth MT, Fichtl RE, Behta M, Raisch DW, Mendez-Rico E, Adams A et al.. Incidence and impact of adverse drug events in pediatric inpatients. Arch Pediatr Adolesc Med. 2003; 157:60-65.
• [42]Bates DW, Miller EB, Cullen DJ, Burdick L, Williams L, Laird N et al.. Patient risk factors for adverse drug events in hospitalized patients. Arch Intern Med. 1999; 159:2553-2560.