Reacciones adversas a medicamentos en niños hospitalizados: Un problema de salud pública

Noelia Speranza; Liriana Lucas; Héctor Telechea; Adriana Santurio; Gustavo Giachetto; Luciana Nanni

Authors

Noelia Speranza Universidad de la República. Facultad de Medicina. Farmacología y Terapéutica, Asistente. Clínica Pediátrica, Residente
Liriana Lucas Universidad de la República, Facultad de Medicina, Farmacología y Terapéutica, Ayudante. Clínica Pediátrica, Residente
Héctor Telechea Universidad de la República, Facultad de Medicina, Asistente de Farmacología y Terapéutica. Clínica Pediátrica, Residente
Adriana Santurio Química Farmacéutica
Gustavo Giachetto Universidad de la República, Facultad de Medicina, Farmacología y Terapéutica, Profesor Agregado. Clínica Pediátrica, Profesor Agregado. Codirector del CIEM
Luciana Nanni Uruguay, Centro Hospitalario Pereira Rossell, Directora de Farmacia. Ministerio de Salud Pública, Codirectora del CIEM. Dra. Q.F

Keywords:

PHARMACEUTICAL PREPARATIONS, ADVERSE EFFECTS, HOSPITALIZED CHILD

Abstract

Introduction: globally, drug-caused diseases are a public health issue. In Uruguay, the importance of this topic is unknown.
Objective: to describe the characteristics and to estimate the frequency of adverse drug reaction (ADR) through intensive pharmacovigilance (PV) of hospitalized children in the Pediatric Hospital at the Pereira Rossell Hospital.
Methods: technical staff from the Drug Information and Evaluation Center performed a thorough pharmacological anamnesis in children hospitalized on the 1st, 2nd and 3rd floors of the the Pediatric Hospital at the Pereira Rossell Hospital between 28 June and 4 July, 2007. All children suspected of ADR were included in the study. We analyzed age, sex, drugs implied, diseases caused, severity and evolution.
Results: 24 cases of suspect ADR were identified in 173 hospitalized children.
Average age was 3 years old. Frequency of ADR was 13.9% (confidence interval was 95%, 8.9-18.9). ADR was the primary cause for hospitalization in three children out of 24. Systemic antiinfectious (n=10) and antiepileptics (n=4) were the most frequent drugs causing ADR. The following ADR were identified: digestive (n=9), metabolic (n=5), cutaneous (n=3), cardiovascular (n=3), neurological (n=2), congenital malformation (n=1) and hematological (n=1). In seven cases, ADR was severe and in five of them it was mild or moderate. No patient required intensive care hospitalization, and none of them died. In 7 patients the RAM was severe, and in 5 of them, moderate. None of the patients required intensive care nor were there deaths.
Conclusions: ADR constituted a frequent health problem. Thus, in order to confront it, we need to include identification and prevention practices in clinical services.

References

(1) Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA 1998; 279: 1200-5.
(2) Mitchell AA, Lacouture PG, Sheedan JE, Kauffman RE, Shapiro S. Adverse drug reactions leading to hospital admission. Pediatrics 1988; 82: 24-9.
(3) Pirmohamed M, James S, Meakin S, Green C, Scott A, Walley T, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18.820 patiens. BMJ 2004; 329: 15-9.
(4) 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: 77-83.
(5) Giachetto G, Danza A, Lucas L, Cristiani F, Cuñetti L,Vázquez X, et al. Admissions to a University Hospital for adverse drug reactions and patient’s interruption of treatment. Drug Saf 2007; 30(10): 919-90.
(6) Gutiérrez S, Repetto M. Episodios adversos a medicamentos, detectados en dos servicios de internación pediátrica del Centro Hospitalario Pereira Rossell. Arch Pediatr Urug 2004; 75(4): 307-15.
(7) Valsecia M, Malgor L. Farmacocinética y farmacodinamia en pediatría. In: Valsecia M, Malgor L. Farmacología médica. 2000: 77-87. v. 4. Obtenido de: https://med.unne.edu.ar/catedras/farmacologia/temas_farma/volumen4/cap4_pediatric.pdf (Consulta: 10 dic. 2007).
(8) Leary P. Adverse reactions in children. Specials considerations in prevention and management. Drug Saf 1991; 6: 171-82.
(9) de Abajo Iglesias FJ, Madurga Sanz M, Montero Corominas D, Martín-Serrano García G. La farmacovigilancia en una agencia de regulación de medicamentos: fines y estrategias. Rev Pediatr Aten Primaria 2003; 5: 683-706.
(10) Raffaeli P, Rocchi F, Bonati M, Jong G, Rane M, Knoeppel C, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000; 329; 79-82.
(11) Choonara I, Conroy S. Unlicensed and off-label drug use in children. Implications for safety. Drug Saf 2002; 25(1): 1-5.
(12) Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000; 320(8): 79-82.
(13) Danés Carreras I, Fuentes Camps I, Arnau de Bolós JM, Pandolfi C, Bonati M, Sammons H, et al. Un registro europeo de ensayos clínicos en niños. An Pediatr (Barc) 2004; 60(3): 212-4.
(14) van den Bemt PM, Egberts AC, Lenderink AW, Verzijl JM, Simons KA, van der Pol WS, et al. Risk factors for the development of adverse drug events in hospitalized patiens. Pharm World Sci 2000; 22(2): 62-6.
(15) Dos Santos DB, Coelho HL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiol Drug Saf 2006; 15(9): 635-40.
(16) Organización Mundial de la Salud. La farmacovigilancia: garantía de seguridad en el uso de los medicamentos. Ginebra: OMS, 2004. WHO/EDM/2004.8 (Perspectivas políticas de la OMS sobre medicamentos, 9).
(17) Laporte J. Farmacovigilancia en el hospital. In: Laporte J, Tognoni G. Principios de epidemiología del medicamento. 2 ed. Barcelona: Masson, 1993: 219-29.
(18) Laporte J, Capellà D. Mecanismo de producción y diagnóstico clínico de los efectos indeseables producidos por medicamentos. In: Laporte J, Tognoni G. Principios de epidemiología del medicamento. 2 ed. Barcelona: Masson, 1993: 95-109.
(19) Uppsala Monitoring Centre. Vigilancia de la seguridad de los medicamentos. Guía para la instalación y puesta en funcionamiento de un Centro de Farmacovigilancia. Uppsala: UMC-HWO, 2001. Obtenido de: http://www.who-umc.org/graphics/4808.pdf (Consulta: 18 dic. 2007).
(20) Thürmann PA. Methods and systems to detect adverse drug reactions in hospitals. Drug Saf 2001; 24(13): 961-8.
(21) Le J, Nguyen T, Law A, Hodding J. Adverse drug reactions among children over a 10-year period. Pediatrics 2006; 118: 555-62.
(22) Rylance G, Woods C, Cullen R, Rylance M. Use of drugs by children. BMJ 1988; 297: 445-7.
(23) Pilzer J, Burke T, Mutnick A. Drug allergy assessment at a university hospital and clinic. Am J Health Syst Pharm 1996; 53: 2970-5.
(24) Morales-Olivas F, Martínez-Mir I, Ferrer J, Rubio E, Palop V. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol 2000; 53: 1076-80.
(25) Segal A, Doherty K, Leggott J, Zlotoff B. Cutaneous reactions to drugs in children. Pediatrics 2007; 120: e1082-96.
(26) Vargas F, Schuler-Faccini L, Brunoni D, Kim C, Meloni V, Sugayama S, et al. Prenatal exposure to misoprostol and vascular disruption defects: a case-control study. Am J Med Genet 2000; 95(4): 302-6.