Fan Hui Wen, Monteiro Wuelton Marcelo
Divisão Bioindustrial, Instituto Butantan, São Paulo, Brazil.
Escola Superior de Ciências da Saúde, Universidade do Estado do Amazonas, Manaus, Brazil; Instituto de Pesquisa Clínica Carlos Borborema, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil; Pró-Reitoria de Pós-Graduação e Pesquisa, Universidade Nilton Lins, Manaus, Brazil.
Toxicon. 2018 Sep 1;151:15-23. doi: 10.1016/j.toxicon.2018.06.070. Epub 2018 Jun 13.
A plan to achieve self-sufficiency in manufacturing biologicals for public health has been structured for the last 40 years in Brazil, in the context of a reform in the health system. Industrial plants of the national public laboratories have been modernized, and a program for reducing morbidity and mortality of venomous snakebite has been created, as part of the National Epidemiological Surveillance System. The epidemiological data are essential to plan for the antivenom production of 400,000 vials of snake antivenoms per year, and the acquisition by the Ministry of Health, which is the exclusive purchaser in the country. Distribution is decentralized to reach hospitals in almost 3000 municipalities, and to provide free of charge antivenom treatment. The National Sanitary Surveillance Agency organized the regulatory environment to implement rules and supervise compliance of GMP procedures, elevating the quality of the biologicals that are produced, as well as reducing the costs in production. Despite all the advances in the health system, antivenom availability and accessibility is not uniform in regards to the most vulnerable parts of the populations, which inhabit remote areas in the Brazilian Amazon region. Better logistics and transportation of liquid form antivenoms is an issue to be addressed and realistic and comprehensive health programs for indigenous groups should be effectively structured, in order to reduce the high morbidity and mortality rates associated with snakebite envenoming.
在卫生系统改革的背景下,巴西在过去40年里制定了一项实现公共卫生生物制品制造自给自足的计划。国家公共实验室的工业厂房已实现现代化,并且作为国家流行病学监测系统的一部分,制定了一项降低毒蛇咬伤发病率和死亡率的计划。流行病学数据对于规划每年生产40万瓶蛇毒抗血清以及卫生部(该国唯一的采购方)的采购至关重要。分发工作实行去中心化,以覆盖近3000个市镇的医院,并提供免费的抗血清治疗。国家卫生监督局构建了监管环境,以实施相关规则并监督药品生产质量管理规范程序的合规情况,提高了所生产生物制品的质量,同时降低了生产成本。尽管卫生系统取得了所有这些进展,但对于居住在巴西亚马逊地区偏远地区的最弱势群体而言,抗血清的可获得性和可及性并不统一。改善液体形式抗血清的物流和运输是一个需要解决的问题,并且应该有效地构建针对原住民群体的切实可行且全面的卫生项目,以降低与蛇咬伤中毒相关的高发病率和死亡率。