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Protocolo De Estudio Sobre Las Características De La Prescripción, Disponibilidad Y Expendio De Antimicrobianos En Establecimi

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Protocolo De Estudio Sobre Las Características De La Prescripción, Disponibilidad Y Expendio De Antimicrobianos En Establecimi PROTOCOLO DE ESTUDIO SOBRE LAS CARACTERÍSTICAS DE LA PRESCRIPCIÓN, DISPONIBILIDAD Y EXPENDIO DE ANTIMICROBIANOS EN ESTABLECIMIENTOS DE SALUD DEL PRIMER NIVEL DE ATENCIÓN DIGEMID Protocolo de Estudio sobre las Características de la Prescripción, Disponibilidad y Expendio de Antimicrobianos en Establecimientos de Salud del Primer Nivel de Atención Ministerio de Salud Dr. Alvaro Vidal Rivadeneyra Ministro de Salud Dr. Ismael Muñoz Saenz Viceministro de Salud Dr. Juan Villacorta Santamato Director General de la Dirección General de Medicamentos, Insumos y Drogas Dra. Amelia Villar López Directora Ejecutiva de la Dirección Ejecutiva de Acceso y Uso de Medicamentos Dra. Luz Esther Vasquez Vasquez Directora Nacional del Proyecto Vigía Esta publicación fue realizada con el apoyo técnico y financiero del Proyecto VIGIA “Enfrentando a las amenazas de las enfermedades emergentes” (convenio de Cooperación entre el Ministerio de Salud del Perú y la Agencia de los Estados Unidos para el Desarrollo Internacional, USAID). RECONOCIMIENTOS ENTIDAD TITULAR Ministerio de Salud MINSA Dirección General de Medicamentos, Insumos y Drogas DIGEMID ENTIDAD AUSPICIADORA Proyecto VIGÍA MINSA/USAID RESPONSABLES DE LA INVESTIGACIÓN EQUIPO COORDINADOR + Dra. Q.F. Amelia Villar López (DIGEMID) + Dra. Q.F. Sofía Salas Pumacayo (DIGEMID) + Dr. Q.F. Jan Karlo Zavalaga Minaya (DIGEMID) + Dra. Q.F. María del Rosario Lázaro Bedia (DIGEMID) + Dra. Q.F. Janeth Bouby Cerna (Proyecto VIGÍA) EQUIPO CONSULTOR Acción Internacional para la Salud + Dr. Q.F. Germán Rojas Caro + Dr. César Sangay Callirgos + Dr. Miguel Campos Sánchez + Dr. Rubén Espinoza Carrillo EQUIPO DE COLABORADORES + Dr. Alejandro Midzuaray Midzuaray (OPS/OMS Perú) + Dra. Q.F. Lidia Castillo Solórzano (DIGEMID) + Dr. Gelberth Revilla Stamp (DISA Lima Este) + Dr. Q.F. Gustavo Granados Cairampoma (DISA Lima Este) EQUIPO DE PROFESIONALES PARA LA VALIDACIÓN + Dra. Q.F. Patricia Respicio López - Coordinadora (DISA Lima Este) + Dra. Q.F. Magali Chanca Antonio (DISA Lima Este) + Dra. Q.F. Nancy Hernández Atúncar (DISA Lima Este) + Dra. Q.F. Haydee Lapa Barzola (DISA Lima Este) + Dra. Q.F. Fanny Mesías Flores (DISA Lima Este) + Dr. Q.F. César Pavón Fabián (DISA Lima Este) + Dra. Q.F. Clorinda Silva Jaimes (DISA Lima Este) + Dra. Q.F. Olivia Chiroque Sotelo (+) (DISA Lima Este) + Dr. Q.F. Pedro Lacho Quispe (DISA Lima Este) + Dra. Q.F. Eliana Leyva Puente (DISA Lima Este) + Dra. Q.F. Magali Llatas Gonzáles (DISA Lima Este) + Dra. Q.F. Ely Olivares Medina (DISA Lima Este) + Dra. Q.F. Jenny Oré Ybala (DISA Lima Este) + Dra. Q.F. Janette Rojas Rueda (DISA Lima Este) Agradecemos a la DISA Lima Este por el apoyo y las facilidades brindadas en representación de su Director de Salud Dr. Danty León Guarniz y al equipo de profesionales que colaboraron en el estudio piloto quienes aportaron al protocolo de estudio. (+) Falleció. Protocolo de estudio sobre las características de la prescripción, disponibilidad y expendio de antimicrobianos en establecimientos de salud del primer nivel de atención. ÍNDICE INTRODUCCIÓN 7 JUSTIFICACIÓN Y PROPÓSITO 11 OBJETIVOS 13 + Objetivo General 13 + Objetivo Específico 13 METODOLOGÍA 15 1. Variables del estudio 15 2. Definición operacional de las variables del estudio 15 3. Sujetos de estudio 15 4. Diseño muestral 16 5. Ventajas del diseño 17 6. Desventajas del diseño 18 7. Procedimientos: etapa de preparación, recopilación de datos, procesamiento, análisis y culminación 18 7.1 Organización del estudio 18 7.1.1 Conformación del equipo de la DISA 18 7.1.2 Funciones y responsabilidades 18 7.1.3 Preparación del material para la ejecución del estudio 19 7.1.4 Capacitación de los encuestadores 20 7.2 Aplicación de los formularios 20 7.3 Procesamiento y Análisis 20 7.4 Culminación del estudio 20 5 Protocolo de estudio sobre las características de la prescripción, disponibilidad y expendio de antimicrobianos en establecimientos de salud del primer nivel de atención. ANEXOS 21 ANEXOA: INDICADORES SOBRE PRESCRIPCIÓN, DISPONIBILIDAD Y EXPENDIO DE ANTIMICROBIANOS EN ESTABLE- CIMIENTOS DE SALUD DEL PRIMER NIVEL DE ATENCIÓN 23 ANEXO B: FORMULARIOS DE ATENCIONES 28 ANEXO C: FORMULARIO DE EXPENDIO 30 ANEXO B1: INSTRUCTIVO PARA EL FORMULARIO SOBRE ATENCIONES ANEXO C1: INSTRUCTIVO PARA EL FORMULARIO SOBRE EXPENDIO 32 ANEXO D: GUIA PARA EL CAPACITADOR 35 ANEXO E: PRESENTACIÓN PROTOCOLO 37 ANEXO F: ESTRUCTURAY MODELO DE INFORME 39 ANEXOG: LISTADO DE ANTIMICROBIANOS DEL PETITORIO 42 NACIONAL DE MEDICAMENTOS ESENCIALES DEL PERÚ 2002 - MINISTERIO DE SALUD - DIRECCIÓN GENERAL DE MEDICAMENTOS, INSUMOS Y DROGAS ANEXO H: LISTADO DE ANTIMICROBIANOS DE USO RESTRINGIDO 49 DEL PETITORIO NACIONAL DE MEDICAMENTOS ESENCIALES DEL PERÚ 2002 - MINISTERIO DE SALUD DIRECCIÓN GENERAL DE MEDICAMENTOS, INSUMOS Y DROGAS ANEXO I: INSTRUCTIVO DEL SOFTWARE 52 ANEXO J: LISTA DE ANTIMICROBIANOS SEGÚN CLASIFICACIÓN ATC 54 (Agosto del 2003) 68 GLOSARIO 78 BIBLIOGRAFÍA 80 6 Protocolo de estudio sobre las características de la prescripción, disponibilidad y expendio de antimicrobianos en establecimientos de salud del primer nivel de atención. INTRODUCCIÓN Los antimicrobianosa juegan un rol fundamental en el tratamiento de las enfermedades infecciosas, contribuyendo a una dramática reducción en la morbilidad y mortalidad dependientes de estas patologías1,2,3 . Los beneficios que brindan los antimicrobianos deben sopesarse frente a las consecuencias que puede ocasionar su uso inapropiadob . Las razones por las cuales se debe preservar a los antimicrobianos como herramientas terapéuticas son diversas, entre ellas: a) la creciente resistencia bacteriana; b) la ocurrencia de reacciones adversas y c) la repercusión económica para los sistemas de salud y las familias.4,5,6,7,8,9,10,11,12 El incremento de la resistencia a los antimicrobianos, sobre todo en enfermedades prevalentes, está relacionado con su uso inapropiado. Los antimicrobianos son algunos de los agentes más citados por errores de medicación y ocupan los primeros lugares en los gastos de farmacia.13,14,15,16,17 El incremento de resistencia bacteriana da lugar también al uso de medicamentos nuevos y a menudo más caros, ocasionando gastos innecesarios y exagerados. Aproximadamente el 30% de los pacientes hospitalizados se exponen a los antimicrobianos, estimándose entre el 31 al 65% su uso inadecuado. Otros gastos se derivan del incremento de la morbilidad y la mortalidad, ocasionadas por la epidemia de organismos multirresistentes. 6,9,16,17,18,19,20,21,22,23,24,25 aAntimicrobiano (ATM), es la sustancia o agente que destruye microorganismos o que inhibe su crecimiento o su replicación. Para el estudio se consideran los ATM del Anexo J según clasificación ATC. bUso inapropiado: selección incorrecta, uso innecesario, dosis, duración y frecuencia que no corresponden a los requerimientos individuales del paciente o de la enfermedad. 7 Protocolo de estudio sobre las características de la prescripción, disponibilidad y expendio de antimicrobianos en establecimientos de salud del primer nivel de atención. Las infecciones agudas en pacientes ambulatorios son generalmente tratadas por médicos de atención primaria, en visitas de corta duración; existiendo, en este contexto, evidencias que el uso inapropiado de antimicrobianos es la principal causa para la resistencia de patógenos respiratorios de la comunidad. Otros estudios revelan también los graves problemas de salud pública por resistencia a los antimicrobianos, debido a su uso inapropiado en infecciones de vías respiratorias altas.26,27,28,29 Van Buchem y colaboradores han estudiado prospectivamente 214 pacientes con sinusitis aguda, 108 tratadas con amoxicilina, 750 mg cada 8 horas, y 106 con placebo cada 8 horas. El resultado clínico y radiológico a la semana fue similar, con un 83% y un 77% respectivamente de curación; a los 15 días todos estaban curados. La recaída posterior fue idéntica en ambos grupos. En cambio los efectos adversos se observaron en 28% en el grupo con tratamiento antimicrobiano y en 9% en el grupo tratado con placebo. Los autores concluyen que, en esta condición, no hay argumento a favor del tratamiento antimicrobiano.30 En España, en el 2001, al evaluar la sensibilidad del neumococo frente a los antimicrobianos más utilizados en Atención Primaria de Salud, se reportó que es resistente a la penicilina, los macrólidos y las cefalosporinas en un 47.5%, 35.1% y 16.4%, respectivamente; también empezó a detectarse resistencia a las nuevas quinolonas (2,6%). Un estudio desarrollado por el Instituto Nacional de Salud de Perú, para determinar el grado de resistencia bacteriana a medicamentos antituberculosos, evidenció el incremento de resistencia primaria y adquirida a drogas únicas y asociadas, entre el periodo 1995 y 1999.31 Estudios en América Latina muestran resultados variables de prescripción de antimicrobianos en el ámbito ambulatorio, en el orden del 60%, con tendencia a prescribir entidades de reciente introducción - ß-betalactámicos junto a inhibidores de ß-lactamasa, macrólidos y quinolonas - para infecciones agudas de vías respiratorias altas, desplazando a los antimicrobianos tradicionales y sin mediar estudios de resistencia bacteriana.15 Igualmente, en América Latina, el uso inadecuado de antimicrobianos ha provocado el incremento de resistencia bacteriana; algunos estudios revelan que el 27% de las cepas de Haemophylus influenzae son resistentes a aminopenicilinas y cloranfenicol, y del 10% al 50% de uropatógenos son resistentes a las aminopenicilinas. Asimismo, se observa una epidemia de multirresistencia
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