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The occurrence of adverse drug reactions is an important issue due to the lack of drug safety data in children.


To describe the Adverse Drug Reactions in inpatient children under 6 years of age in two general pediatrics wards located in Barranquilla, Colombia.


A prospective cohort study based on intensive pharmacovigilance was conducted during six months in order to monitor the emergence of Adverse Drug Reactions in inpatients children under 6 years of age with at least one medication prescribed. The study was conducted in two pediatric wards of two hospitals located in Barranquilla, Colombia. Naranjo´s Algorithm was used to evaluate imputability, the modified Hartwig and Siegel assessment scale to establish severity and the Schumock and Thornton criteria to determine preventability.


Of a total of 772 monitored patients, 156 Adverse Drug Reactions were detected on 147 children. The cumulative incidence of Adverse Drug Reactions was 19.0% (147/772); the incidence density was 37.6 Adverse Drug Reactions per 1,000 patients-days (147/3,913). The frequency was higher in children under 2 years of age (12.7%). Emergence of Adverse Drug Reactions was higher in male patients (RR= 1.66; 95% CI= 1.22 to 2.22, p= 0.001) and in those who used systemic antibiotics (RR= 1.82; 95% CI= 1.17 to 2.82, p= 0.005).


Adverse Drug Reactions are common among hospitalized children and represent an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics.

Roxana De las salas, Department of Nursing Universidad del Norte

Assistant professor

Department of Nursing

Daniela Díaz-Agudelo, Department of Nursing Nursing Research Group Universidad del Norte

Department of Nursing

Francisco Javier Burgos-Flórez, Biomimetics Laboratory, Instituto de Biotecnología Universidad Nacional de Colombia

Biomimetics Laboratory

Claudia Vaca, Department of Pharmacy Universidad Nacional de Colombia

Departmen of Pharmacy

Dolores Vanessa Serrano-Meriño, Department of Nursing Nursing Research Group

Department of Nursing
De las salas, R., Díaz-Agudelo, D., Burgos-Flórez, F. J., Vaca, C., & Serrano-Meriño, D. V. (2016). Adverse drug reactions in hospitalized colombian children. Colombia Medica, 47(3), 142–47.

Walsh J, Mills S. Conference report: formulating better medicines for children: 4th European Paediatric Formulation Initiative conference. Ther Deliv. 2013;4(1):21–25

Schirm E, Tobi H, de Vries TW, Choonara I, De Jong-van den Berg LT. Lack of appropriate formulations of medicines for children in the community. Acta Paediatr. 2003;92(12):1486–1489

Hennessy S, Strom BL. PDUFA reauthorization--drug safety's golden moment of opportunity. N Engl J Med. 2007;356:1703–1704

Thiesen S, Conroy EJ, Bellis JR, Bracken LE, Mannix HL, Bird KA, et al. Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children - a prospective observational cohort study of 6,601 admissions. BMC Medicine. 2013;11(1):1–10

Temple ME, Robinson RF, Miller JC, Hayes JR, Nahata MC. Frequency and preventability of adverse drug reactions in paediatric patients. Drug Saf. 2004;27(11):819–829

Bermúdez IB, Real N, Acosta JR, Rodríguez A. Farmacovigilancia intensiva en pacientes adultos y pediátricos. Revista Cubana de Farmacia. 1999;33(2):111–115

OPS. Buenas prácticas de Farmacovigilancia de las Américas. Documento Técnico No. 5. Washintong D.C.: Red Panamericana de Armonización de la Reglamentación Farmacéutica; 2011. Available from: . 1 April 2016.

The Uppsala Monitoring Centre. Glossary of terms used in Pharmacovigilance. Uppsala; 2011. Available from: . 1 April 2016

Star K, Noren GN, Nordin K, Edwards IR. Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase. Drug Saf. 2011;34(5):415–428

dos Santos DB, Coelho HL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiol Drug Saf. 2006;15(9):635–640

Belén Rivas A, Arruza L, Pacheco E, Portoles A, Diz J, Vargas E. Adverse drug reactions in neonates: a prospective study. Arch Dis Child. 2016;101:371–376

International Conference on Harmonisation (ICH). Post-approval safety data management: definitions and standards for expedited reporting E2D - 2003. Available from: . 1 April 2016

Naranjo C, Busto U, Sellers E, Sandor P, Ruiz I, Roberts E, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–245

Naranjo CA, Shear NH, Lanctot KL. Advances in the diagnosis of adverse drug reactions. J Clin Pharmacol. 1992;32(10):897–904

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229–2232

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27(6):538

Ceci A, Giaquinto C, Aboulker JP, Baiardi P, Bonifazi F, Della Pasqua O, et al. The Task-force in Europe for Drug Development for the Young (TEDDY) Network of Excellence. Paediatr Drugs. 2009;11(1):18–21

WHO. ATC/DDD Index. WHO Collaborating Centre for Drug Statistics Methodology; 2013. Available from: uri . 1 April 2016

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(9):965–968

Jimenez R, Smith A, Carleton B. New Ways of Detecting ADRs in Neonates and Children. Curr Pharm Des. 2015;21(39):5643–5649

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(6):681–688

Alomar MJ. Factors affecting the development of adverse drug reactions. Saudi Pharm J. 2014;22(2):83–94

Speranza N, Lucas L, Telechea H, Santurio A, Giachetto G, Nanni L. Reacciones adversas a medicamentos en niños hospitalizados: un problema de salud pública. Rev Méd Uruguay. 2008;24(3):161–166

Aagaard L, Weber CB, Hansen EH. Adverse drug reactions in the paediatric population in Denmark: a retrospective analysis of reports made to the Danish Medicines Agency from 1998 to 2007. Drug Saf. 2010;33(4):327–339

Furones Mourelle JA, Cruz Barrios MA, López Aguilera ÁF, Martínez Núñez D, Alfonso Orta I. Reacciones adversas por antimicrobianos en niños de Cuba. Rev Cubana Med Gen Integral. 2015;31(2):205–216

Li H, Guo X-J, Ye X-F, Jiang H, Du W-M, Xu J-F, et al. Adverse Drug Reactions of Spontaneous Reports in Shanghai Pediatric Population. PLoS One. 2014;9(2):e89829

Rashed A, Wong IK, Cranswick N, Tomlin S, Rascher W, Neubert A. Risk factors associated with adverse drug reactions in hospitalised children: international multicentre study. European J Clin Pharmacol. 2012;68(5):801–810

Oshikoya KA, Chukwura H, Njokanma OF, Senbanjo IO, Ojo I. Incidence and cost estimate of treating pediatric adverse drug reactions in Lagos, Nigeria. Sao Paulo Med J. 2011;129(3):153–164

Sepahi M, Movahed Z, Heydari H, Shirkhodai M, Shokrollahi M. Surveillance of Adverse Drug Reaction in Hospitalized Children, A Cross Sectional Study from Qom Province, Iran. Life Sci J. 2013;10(12s):122–125

Star K, Edwards IR. Pharmacovigilance for Children's Sake. Drug Safety. 2014;37(2):91–98

Shamna M, Dilip C, Ajmal M, Linu Mohan P, Shinu C, Jafer CP, et al. A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Pharmaceutical Journal: SPJ. 2014;22(4):303–308

Vallejos A. Reacciones Adversas por antibióticos en una Unidad de Cuidado Intensivo Pediátrico y Neonatal de Bogotá. Biomédica. 2007;27:66–75

Pinheiro LF, Franca CN, Izar MC, Barbosa SP, Bianco HT, Kasmas SH, et al. Pharmacokinetic interactions between clopidogrel and rosuvastatin: Effects on vascular protection in subjects with coronary heart disease. Int J Cardiol. 2012;158(1):125–129


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Received 2016-01-11
Accepted 2016-07-17
Published 2016-09-21