Atukunda Esther Cathyln, Brhlikova Petra, Agaba Amon Ganafa, Pollock Allyson M
Mbarara University of Science and Technology, Uganda.
Queen Mary University of London, United Kingdom.
Soc Sci Med. 2015 Apr;130:242-9. doi: 10.1016/j.socscimed.2015.02.022. Epub 2015 Feb 18.
Misoprostol use for postpartum haemorrhage (PPH) has been promoted by Civil Society Organizations (CSOs) since the early 2000s. Yet, CSOs' role in improving access to misoprostol and shaping health policy at global and national levels is not well understood. We document the introduction of misoprostol in Uganda in 2008 from its registration, addition to treatment guidelines and national Essential Medicines List (EML), to its distribution and use. We then analyse the contribution of CSOs to this health policy change and service provision. Policy documents, procurement data and 82 key informant interviews with government officials, healthcare providers, and CSOs in four Ugandan districts of Kampala, Mbarara, Apac, Bundibugyo were collected between 2010 and 2013. Five key CSOs promoted and accelerated the rollout of misoprostol in Uganda. They supported the registration of misoprostol with the National Drug Authority, the development of clinical guidelines, and the piloting and training of health care providers. CSOs and National Medical Stores were procuring and distributing misoprostol country-wide to health centres two years before it was added to the clinical guidelines and EML of Uganda and in the absence of good evidence. The evidence suggests an increasing trend of misoprostol procurement and availability over the medicine of choice, oxytocin. This shift in national priorities has serious ramifications for maternal health care that need urgent evaluation. The absence of clinical guidelines in health centres and the lack of training preclude rational use of misoprostol. CSOs shifted their focus from the public to the private sector, where some of them continue to promote its use for off-label indications including induction of labour and abortion. There is an urgent need to build capacity to improve the robustness of the national and local institutions in assessing the safety and effectiveness of all medicines and their indications in Uganda.
自21世纪初以来，民间社会组织（CSO）一直在推动米索前列醇用于产后出血（PPH）。然而，民间社会组织在改善米索前列醇的可及性以及在全球和国家层面塑造卫生政策方面所发挥的作用尚未得到充分理解。我们记录了2008年米索前列醇在乌干达的引入过程，从其注册、被纳入治疗指南和国家基本药物清单（EML），到其分发和使用情况。然后，我们分析了民间社会组织对这一卫生政策变化和服务提供的贡献。在2010年至2013年期间，收集了政策文件、采购数据，并对坎帕拉、姆巴拉拉、阿帕克、本迪布焦四个乌干达地区的政府官员（GO）、医疗服务提供者（HCP）和民间社会组织进行了82次关键信息人访谈。五个主要的民间社会组织推动并加速了米索前列醇在乌干达的推广。他们支持米索前列醇在国家药品管理局的注册、临床指南的制定以及对医疗服务提供者的试点和培训。在米索前列醇被纳入乌干达的临床指南和基本药物清单之前两年，且缺乏充分证据的情况下，民间社会组织和国家医疗用品商店就在全国范围内向卫生中心采购和分发米索前列醇。有证据表明，米索前列醇的采购量和可及性相对于首选药物缩宫素呈上升趋势。国家优先事项的这种转变对孕产妇保健产生了严重影响，需要紧急评估。卫生中心缺乏临床指南以及缺乏培训妨碍了米索前列醇的合理使用。民间社会组织将其重点从公共部门转移到了私营部门，其中一些组织继续推动米索前列醇用于包括引产和堕胎在内的非标签适应症。迫切需要建设能力，以提高国家和地方机构在评估乌干达所有药物及其适应症的安全性和有效性方面的稳健性。
