FARMACOVIGILANCIA Y PRODUCTOS FALSIFICADOS
Entre las actividades relacionadas a la farmacovigilancia, se considera las referidas a cualquier otro problema relacionado con los medicamentos, dentro del cual se incluye los efectos adversos relacionados al uso de productos falsificados. La falsificación de medicamentos y otras formas de comercio ilegal, son un problema a nivel mundial, lo cual requiere un trabajo multisectorial debido al riesgo que representan para la salud de la población.
La OMS y la Organización Internacional de Policía Criminal (conocida mundialmente como Interpol), señalan que la falsificación de medicamentos (conocida localmente como “medicina bamba”) y otras formas de comercio ilegal aumentó de forma continua durante de la pandemia, observándose que el 50% de estos medicamentos son vendidos a través de internet1. En el Perú se han desarrollado intervenciones para la prevención y reducción del riesgo asociado al uso, comercialización y promoción de productos farmacéuticos, mediante actividades de control y vigilancia de la seguridad, calidad, uso racional y del comercio ilegal de estos productos. Para el control de calidad de los medicamentos incautados en el comercio ilegal se realizan ensayos fisicoquímicos y microbiológicos, para establecer si el producto cumple con las especificaciones técnicas declaradas por el titular del registro sanitario; dichos análisis se realizan en el Centro Nacional de Control de Calidad del Instituto Nacional de Salud.
El control y vigilancia del mercado farmacéutico contribuye a la erradicación del comercio ilegal, adulteración, falsificación y contrabando de los medicamentos a nivel nacional, promoviendo la participación multisectorial. El uso de estos productos ilegales constituye un riesgo grave para la salud en la población, ya que pueden afectar la salud de las personas, al disminuir el efecto terapéutico, provocar una sospecha de reacción adversa a medicamento (SRAM) u otros efectos nocivos para la salud2. La OMS puntualiza a los productos médicos falsificados como “productos médicos que tergiversan deliberada o fraudulentamente su identidad, composición u origen”
El Minsa, en el marco de la Política Nacional de Medicamentos, contribuye a garantizar la seguridad, eficacia y calidad de todos los productos farmacéuticos que se comercializan en el mercado nacional y, en lo que corresponde a la erradicación del contrabando, el comercio informal y falsificación de productos, establece entre sus lineamientos la participación multisectorial para luchar contra estos problemas, aplicando mecanismos administrativos y penales. En ese sentido, se aprobó la conformación del “Grupo técnico multisectorial de prevención y combate al contrabando, comercio ilegal y falsificación de productos farmacéuticos y afines”, mediante la Resolución Ministerial N.º 047-2006-PCM, conocido como GTM/CONTRAFALME (contra la falsificación de medicamentos).
En el Perú, en el 2020 y 2021, se emitieron 90 y 74 alertas de productos falsificados, respectivamente, como parte de las acciones que realiza la Digemid para velar por la salud pública de la población (https://www.digemid.minsa.gob.pe/category/productos-falsificados).
Un estudio analizó 799 alertas que Digemid emitió entre 1997 y 2016, de las cuales el 45.18% (361) fueron sobre medicamentos y se asociaron a 1921 casos de falsificaciones4. Otro estudio reciente, que analizó las alertas emitidas por la Digemid en el periodo 2017-2020, determinó las características de los medicamentos falsificados en el Perú, encontrando que los porcentajes de productos farmacéuticos falsificados incautados en las acciones de control y vigilancia sanitaria en los años 2017, 2018, 2019 y 2020 fueron de 16.1 %, 33.2 %, 35.3 % y 15.5 %, respectivamente. Los mayores porcentajes de productos falsificados correspondían, según el Sistema de Clasificación Anatómica, Terapéutica, Química (ATC, por sus siglas en inglés), al sistema musculo esquelético (18.9%), al sistema respiratorio (18.7%) y al antiinfeccioso para uso sistémico (16.6%); según su forma farmacéutica correspondían a tabletas y comprimidos (41.6% y 16.6%, respectivamente); y según la condición de venta, el 59.7 % correspondían a productos farmacéuticos de venta sin receta médica. Asimismo, la mayor cantidad de productos falsificados se incautó en el departamento de Lima (81.3%) y en establecimientos no farmacéuticos (70%)5.
Los integrantes del SPFT, como parte de sus acciones de farmacovigilancia, deben notificar al Cenafyt cualquier SRAM que se haya presentado con el uso de sus productos farmacéuticos, debiendo codificarla utilizando MedDRA. En la base de datos de farmacovigilancia se realizó la búsqueda utilizando el término de alto nivel (HLT, por sus siglas en inglés) de MedDRA, “Productos falsificados, falsos y subestándares” encontrándose 8 casos que, de acuerdo a su clasificación por término preferido (PT, por sus siglas en inglés), incluían 9 SRAM relacionadas a productos falsificados (07 como “administración de producto falsificado” y 02 como “sospecha de producto falsificado”) y 21 SRAM co-reportadas (malestar, prurito, urticaria, etc.). La tabla 1 muestra a los principios activos de productos farmacéuticos presuntamente falsificados, mientras que la tabla 2 detalla las SRAM, por PT de MedDRA, co-reportadas en los casos relacionados a productos falsificados.
La Digemid, como autoridad reguladora de productos farmacéuticos, dispositivos médicos y productos sanitarios, a través de los equipos contra el comercio ilegal y del Cenafyt, viene trabajando de manera coordinada para advertir a la población sobre los riesgos que implica la adquisición y consumo de medicamentos procedentes de las diversas modalidades del comercio ilegal. El Equipo contra el Comercio Ilegal, mediante las inspecciones y operativos que realiza de rutina, ha detectado diversos productos farmacéuticos falsificados (figura 1), los cuales han sido comunicados a la población. Asimismo, el Cenafyt, complementando las acciones anteriores, organiza campañas nacionales sobre la seguridad de uso de los productos farmacéuticos y participa en la campaña nacional “La medicina bamba mata.
La Digemid hace de conocimiento a la población en general que, cualquier consulta o denuncia de un producto farmacéutico presuntamente falsificado o ilegal puede realizarla de manera anónima en el enlace: http://farmacia-responsable.digemid.minsa.gob.pe/denunciasWeb/DefaultCI. En el caso haya consumido un producto presuntamente falsificado y presente algún efecto adverso, puede notificarlo a través del correo farmacovigilancia@minsa.gob.pe o por el enlace: https://primaryreporting.who-umc.org/PE
Fuente : Boletín de Farmacovigilancia y Tecnovigilancia N°21
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