NUTRITIONAL SUPPORT AND CARDIOPROTECTION WITH L-CARNITINE: PRESCRIPTION APPROPRIATENESS AND SAFETY CONCERNS IN MEXICAN NEONATES
Main Article Content
Keywords
Drug use evaluation, levocarnitine, L-carnitine, neonate, adverse drug reaction
Abstract
Medication errors are probably more common in neonates than is generally appreciated. In Mexican pediatric hospitals, L-carnitine is mainly used for nutritional support and to treat cardiomyopathy secondary to neonatal asphyxia. Using a longitudinal-retrospective approach we assessed the appropriateness of all L-carnitine prescriptions written during a 12-month period at a NICU of a secondlevel hospital located in Toluca, Mexico. Reports of adverse reactions possibly related to L-carnitine therapy were collected and characterized. Overall, administration of L-carnitine was considered justified and appropriate only in 18% of patients. 60.7% of L-carnitine prescriptions were rated as inappropriate because the prescribed doses fell outside the recommendations. The overall rate of ADRs calculated from the patient population was 18.03%. All of them were of gastrointestinal type: abdominal cramps (8 cases, 61.54%) and vomiting (5 cases, 38.46%). Our results supported the establishment of an L-carnitine rational use policy at the NICU of the hospital under study.
References
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33. Gómez-Oliván LM, Márquez-Rodríguez S, Pontigo-Loyola P, Téllez-López A, Amaya- Chávez A, Galar-Martínez M. The prescription of drugs in a dental clinic in a Mexican university hospital. Farm Hosp 2007;31: 169- 172.
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2. Giacoia GP, Birenbaum DL, Sachs HC, Mattison DR. The newborn drug development initiative. Pediatrics 2006;117: S1-S8.
3. American Academy of Pediatrics Policy. Committee on Drugs and Committee on Hospital Care. Prevention of Medication Errors in the Pediatric Inpatient Setting. Pediatrics 2003;112(2):431-436.
4. Crill CM, Helms RA. The use of Carnitine in pediatric nutrition. Nutr Clin Pract 2007; 22(2):204-213.
5. Evangeliou A, Vlassopoulos D. Carnitine metabolism and deficit: when supplementation is necessary? Curr Pharm Biotechno 2003; 4: 211-219.
6. Gomis-Muñoz P, Fernández-Shaw C, Moreno- Villares JM. Encuesta sobre protocolos de elaboración de nutrición parenteral pediátrica y revisión de la idoneidad de sus componentes. Farm Hosp 2002; 26 (3): 163-170.
7. O´Donnell J, Finer NN, Rich W, Barshop BA, Barrington KJ. Role of L-Carnitine in apnea of prematurity: a randomized, controlled trial. Pediatrics 2002; 109(4): 622-626.
8. DRUGDEX® System [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Available from: http://www.thomsonhc.com/ Accessed January 10, 2011.
9. Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics 2006; 117(6): 1979-1987.
10. Figueiras AF, Caamaño F, Gestal-Otero JJ. Metodología de los estudios de utilización de medicamentos en atención primaria. Gac Sanit 2000; 14(suppl.3): 7-19.
11. McEvoy, GK. (2001) AHFS Drug information 2001. American Society of Health-System Pharmacists: Washington. 44th edition.
12. Lacy FC, Armstrong LL, Goldman MP & Lance LL. (2001-2002) Drug Information Handbook. Lexi-Comp, Inc.: Ohio. 9th edition.
13. Dipiro JT. (2002) Pharmacist´s Drug Handbook. American Society of Health-System Pharmacists: Bethesda. 2nd edition.
14. Taketomo CK, Hooding JH, & Krauss DM. (2000-2001). Pediatric Dosage Handbook. Lexi- Comp, Inc.: Ohio. 7th edition.
15. USP DI (2000). Drug Information for the Health Care Professional. USP: Massachusetts. 19th edition.
16. Gossel EA, & Bricker JD. (1990) Principles of Clinical Toxicology. Raven Press: New York. 3rd edition.
17. Tatro DS, ed. Drug Interaction Facts. St. Louis, MO: Wolters Kluwer Health, Inc.; 2000.
18. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30(2): 239-245.
19. Debesa F, Llovet S. La farmacovigilancia, una reflexión 23 años después. Resumed 2000; 13(5): 216-24.
20. Secretaría de Salud (2003) Instalación y operación de la farmacovigilancia. NOM-220- SSA1-2002. Diario Oficial de la Federación: México D.F.
21. Asociación Mexicana de Farmacovigilancia (2006) Guía de Farmacovigilancia para el Reporte de Reacciones/Eventos Adversos Espontáneos. AMFV: México D.F.
22. Rosas-Barrientos JV, Gutiérrez-Muñoz VH, Gutiérrez-Muñoz J. Factores de riesgo en sepsis neonatal en un hospital de tercer nivel en la ciudad de México. Rev Esp Med Quir 2005; 10(2): 21-24.
23. Rígido M, & Sola A. (2001) Cuidados Especiales del Feto y el Recién Nacido: Fisiopatología y Terapéutica T1. Editorial Científica Interamericana: Buenos Aires.
24. Behrman R, Avroy F, Richard M, Merkart I. (1985) Enfermedades del feto y del Recién Nacido. Editorial Científico-Técnica: La Habana.
25. Instituto Nacional de Estadística y Geografía (2010) Estadísticas a propósito del día del niño. INEGI: México D.F.
26. Fontana L, Sáez M, Santisteban R, Gil A. Nitrogenous compounds of interest in clinical nutrition. Nutr Hosp 2006; 21: 15-29.
27. Klein C. Nutrient requirements for preterm infant formulas. J Nutr 2002; 132:1395S-1577S.
28. Towbin J, Lipshultz S. Genetics of neonatal cardiomyopathy. Curr Opin Cardiol 1999; 14(3): 250-62.
29. Jasso L. (2002) Neonatología práctica. El Manual Moderno: México D.F. 5ª edición.
30. Rodríguez-Weber M, Udaeta-Mora E, eds. (2003) Neonatología clínica. McGraw Hill: México D.F. 1st edition.
31. Kelly DP, Strauss AW. Mechanisms of disease: inherited cardiomyopathies. N Engl J Med 1994; 330(13): 913-919.
32. Helton E, Darragh R, Francis P, Fricker J, Jue K, Koch G, et al. Metabolic aspects of myocardial disease and a role for L-Carnitine in the treatment of childhood cardiomyopathy. Pediatrics 2000; 105: 1260-1270.
33. Gómez-Oliván LM, Márquez-Rodríguez S, Pontigo-Loyola P, Téllez-López A, Amaya- Chávez A, Galar-Martínez M. The prescription of drugs in a dental clinic in a Mexican university hospital. Farm Hosp 2007;31: 169- 172.
34. Wirtz VJ, Reich MR, Leyva-Flores R, Dreser A. Medicines in Mexico 1990-2004: systematic review of research on access and use. Salud Pub Mex 2008; 50 (suppl. 4): S470-S479.