Américo Brasiliense State Hospital, Américo Brasiliense, Brazil.
Department of Drugs and Medicines, School of Pharmaceutical Sciences, São Paulo State University, Araraquara, Brazil.
Clin Ther. 2019 Mar;41(3):598-603. doi: 10.1016/j.clinthera.2019.01.013. Epub 2019 Feb 18.
Brazilian pharmacovigilance regulations involve 3 spheres: health services, Marketing Authorization Holders (MAHs), and sanitary agency. Drug tolerability began to be effectively assessed in Brazil after the founding of the National Agency of Sanitary Surveillance, which developed the Sentinel Network Project. The objective of the Sentinel Network Project is to increase the adverse drug reaction (ADR) reporting rate by health care professionals in the hospital setting. Pharmacovigilance practices became mandatory for MAHs, and patient tolerability issues were considered in drug policy in Brazil only as recently as 2000. However, despite recent events, the regulatory advancements in pharmacovigilance in Brazil are only equivalent to international practices (ie, those of the European Union). The pharmacovigilance system in the European Union integrates the national authorities, the European Commission, and the European Medicines Agency, which is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the European Union. Furthermore, ADR patient reporting is included in the new EU pharmacovigilance regulations. Numerous possible ways are available to improve the Brazilian pharmacovigilance system, mainly through regulations of biosimilar, nanotechnology, and veterinary medicines or by training health care professionals and patients to report nonserious cases and quality deviations. It is necessary to encourage and develop strategies for decentralizing pharmacovigilance actions in the whole country, as is common practice in several EU countries. Motivating and considering ADR reports by patients and improving feedback and audit practices in health care services and MAHs are also necessary measures. With the inclusion of Brazil as a member of the International Conference of Harmonization, significant changes in pharmacovigilance regulation are expected; these updates, which will consider international standards, will improve signal detection and risk communication.
卫生服务机构、上市许可持有人（MAH）和卫生机构。国家卫生监督局成立后，巴西开始有效评估药物耐受性，该机构开发了哨点网络项目。哨点网络项目的目的是提高医疗机构中医疗保健专业人员报告药物不良反应（ADR）的比率。药物警戒实践对 MAH 成为强制性要求，直到 2000 年巴西的药物政策才开始考虑患者的耐受性问题。然而，尽管最近发生了这些事件，但巴西药物警戒法规的进展仅相当于国际惯例（即欧盟的惯例）。欧盟的药物警戒系统整合了国家主管部门、欧盟委员会和欧洲药品管理局，后者负责对欧盟范围内用于人类和兽医用途的药品进行科学评估、监督和安全性监测。此外，ADR 患者报告也被纳入欧盟新的药物警戒法规。有许多可能的方法可以改进巴西的药物警戒系统，主要通过对生物类似药、纳米技术和兽用药品的监管、培训医疗保健专业人员和患者报告非严重病例和质量偏差来实现。有必要鼓励并制定策略，在全国范围内分散药物警戒行动，这是欧盟几个国家的常见做法。激励并考虑患者的 ADR 报告，并改进医疗保健服务和 MAH 的反馈和审核实践，也是必要的措施。随着巴西加入国际协调会议，预计药物警戒法规将发生重大变化；这些更新将考虑国际标准，将提高信号检测和风险沟通的效率。
