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Estado de situación y regulación de laboratorios bioanalíticos que cuantifican inmunosupresores para trasplantes en Argentina

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Date
2016-03
Author
Schaiquevich, Paula
Taich, Paula
Riva, Natalia
Leone, Francisco
Paternoster, Nora
Mato, Gabriel
Cáceres Guido, Paulo
Type of paper
Original research
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Abstract
Objetivo. Establecer el estado de situación de los laboratorios analíticos que cuantifican inmunosupresores en pacientes con trasplantes que se encuentran bajo monitoreo terapéutico de drogas (TDM) de estos fármacos en Argentina, para establecer potenciales áreas de actuación perfectibles. Métodos. Se realizó una encuesta en centros clínicos y analíticos de TDM de Argentina, coordinada por la Unidad de Farmacocinética Clínica del Hospital Garrahan y el Instituto Nacional Central Único Coordinador de Ablación e Implante, desde setiembre de 2013 hasta noviembre de 2014. Resultados. Se incluyeron 27 centros clínicos y analíticos (muestra representativa nacional). El 45% fueron hospitales públicos. La mayoría (95%) monitorizan ciclosporina y tacrolimús; en menor medida, sirolimús y everolimús, y muy pocos el ácido micofenólico. La cantidad (mediana, rango) de muestras analizadas por mes para estos cinco fármacos fue de 251 (10 - 2024). Casi 60% de las muestras se analizaron en instituciones privadas. Solo cuatro (17%) de los encuestados informan valores del margen terapéutico. El 92% usa inmunoensayos como metodología analítica. El 68% de los encuestados que contaban con instalaciones bioanalíticas propias informaron poseer algún programa de garantía de calidad. Conclusiones. El TDM de inmunosupresores es una práctica recomendada para pacientes con trasplante en Argentina. Se requiere generar iniciativas nacionales que desarrollen guías armonizadas para laboratorios analíticos que incluyan procesos de garantía de calidad con alcance regulatorio relacionados con el TDM. Por otra parte, también es necesario capacitar al personal técnico y profesional, e invitar a participar a organizaciones públicas y privadas del ámbito regulatorio, sanitario y de la investigación.
 
Objective. Determine the status of analytical laboratories that quantify immunosuppressants in transplant patients who are under therapeutic drug monitoring (TDM) for these drugs in Argentina in order to identify potential perfectible areas for action. Methods. A survey of the clinical and analytical TDM centers in Argentina was conducted between September 2013 and November 2014 under the direction of the Garrahan Hospital Clinical Pharmacokinetics Unit and the National Unified Central Institute for Ablation and Implant Coordination. Results. A nationally representative sample of 27 clinical and analytical centers was identified, of which 45% were public hospitals. Most of these centers (95%) monitor ciclosporin and tacrolimus, and to a lesser extent, sirolimus and everolimus; a small number of them also monitor mycophenolic acid. The median number of samples of these five drugs analyzed per month was 251 (range: 10-2024). Nearly 60% of the samples were analyzed in private institutions. Only four of the respondents (17%) reported values within the therapeutic margin. Of all the centers, 92% use immunoassay as the analytical methodology. Of the bioanalytical installations that have their own facilities, 68% reported that they also have their own quality assurance program. Conclusions. TDM of immunosuppressants is a recommended practice for transplant patients in Argentina. Initiatives need to be taken at the national level to develop uniform guidelines for analytical laboratories that include TDM-related quality assurance processes with regulatory force. There is also a need to train technical and professional personnel and to invite the participation of public and private organizations in the regulatory, public health, and research areas.
 
Translated title
Current status and regulation of bioanalytical laboratories engaged in quantifying immunosuppressants for transplant patients in Argentina
Series
Rev Panam Salud Publica;39(3),mar. 2016
Subject
Farmacocinética; Laboratorios; Inmunosupresores; Control de Calidad; Trasplante; Argentina; Pharmacokinetics; Laboratories; Immunosuppressive Agents; Quality Control; Transplantation
URI
https://iris.paho.org/handle/10665.2/28307
Citation
Schaiquevich P, Taich P, Riva N, Leone F, Paternoster N, Mato G, Cáceres Guido P. Estado de situación y regulación de laboratorios bioanalíticos que cuantifican inmunosupresores para trasplantes en Argentina. Rev Panam Salud Publica. 2016;39(3):142–48.
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  • Pan American Journal of Public Health

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