Bassat Quique, Tanner Marcel, Guerin Philippe J, Stricker Kirstin, Hamed Kamal
Centro de Investigação Em Saúde Da Manhiça (CISM), Maputo, Mozambique.
ISGlobal, Barcelona Centre for International Health Research (CRESIB), Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.
Malar J. 2016 Jun 1;15:302. doi: 10.1186/s12936-016-1357-8.
The circulation of poor-quality medicines continues to undermine the fight against many life-threatening diseases. Anti-malarial medicines appear to have been particularly compromised and present a major public health threat in malaria-endemic countries, negatively affecting individuals and their communities. Concerted collaborative efforts are required from global, regional and national organizations, involving the public and private sectors, to address the problem. While many initiatives are underway, a number of unmet needs deserve urgent and increased multisector attention. At the global level, there is a need for an international public health legal framework or treaty on poor-quality medicines, with statutes suitable for integration into national laws. In addition, increased international efforts are required to strengthen the governance of global supply chains and enhance cooperation between national medicine regulation authorities and law enforcement bodies. Increased investment is needed in innovative technologies that will enable healthcare teams to detect poor-quality medicines at all levels of the supply chain. At the regional level, a number of initiatives would be beneficial-key areas are standardization, simplification, and reciprocal recognition of registration processes and development of quality control capacity in regional centres of excellence that are better aligned with public health needs; improved surveillance methods and creation of a framework for compulsory and transparent reporting of poor-quality medicines; additional support for national medicine regulation authorities and other national partner authorities; and an increase in support for regional laboratories to boost their capabilities in detecting poor-quality medicines. It is vital that all stakeholders involved in efforts against poor-quality anti-malarial medicines extend and strengthen their actions in these critical areas and thus effectively support global health development and malaria elimination programmes.
劣质药品的流通继续破坏对许多危及生命疾病的防治工作。抗疟药品似乎受到了特别严重的影响,在疟疾流行国家构成了重大公共卫生威胁,对个人及其社区产生了负面影响。全球、区域和国家组织需要开展协同合作,包括公共部门和私营部门,以解决这一问题。虽然许多举措正在进行,但一些未得到满足的需求值得多部门紧急给予更多关注。在全球层面,需要制定一项关于劣质药品的国际公共卫生法律框架或条约,其法规应适合纳入国家法律。此外,需要加大国际努力,以加强全球供应链治理,增进国家药品监管当局与执法机构之间的合作。需要加大对创新技术的投资,使医疗团队能够在供应链的各个层面检测出劣质药品。在区域层面,一些举措将大有裨益——关键领域包括标准化、简化以及相互认可注册程序,在更符合公共卫生需求的区域卓越中心发展质量控制能力;改进监测方法,建立劣质药品强制和透明报告框架;为国家药品监管当局和其他国家伙伴当局提供更多支持;增加对区域实验室的支持,以提高其检测劣质药品的能力。参与抗击劣质抗疟药品工作的所有利益攸关方必须在这些关键领域扩大并加强行动,从而有效支持全球卫生发展和疟疾消除计划。