Civil Society Organizations and medicines policy change: A case study of registration, procurement, distribution and use of misoprostol in Uganda

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.