Community Access to Rectal Artesunate for Malaria

Background

Rectal artesunate is a pre-referral intervention for children under 6 years of age, and reduces the risk of death or permanent disability by up to 50% In situations where patients with severe malaria do not have immediate access to injectable artesunate/a referral center, the World Health Organization (WHO) recommends giving children a single rectal dose of artesunate and referring immediately to an appropriate facility where the full management of severe malaria can be provided. Until recently, the lack of a quality assured product and limited operational guidance meant few countries had introduced this pre-referral intervention. Recent work by Medicines for Malaria Venture (MMV) that has been funded by Unitaid has enabled two rectal artesunate products to be submitted for WHO prequalification and both of those have received Global Fund ERP approval, paving the way for this project.

Grant Overview

Unitaid approved three grants to help to prevent malaria deaths among pregnant women and children under 6 year of age, both considered high-risk groups for the disease. Of these three grants, one has been developed to provide quality assured rectal artesunate suppositories (RAS) as a pre-referral intervention for suspected cases of severe malaria in children under 6 and to demonstrate how lives can be saved by managing children with severe malaria before they are able to reach a referral center.

The three-year RAS project, implemented by the Clinton Health Access Initiative (CHAI), will provide pre-referral intervention for more than 5,000 cases of severe malaria per year. UNICEF is responsible for the introduction of RAS as part of their co-funded integrated community case management (iCCM) programs and the Swiss Tropical and Public Health Institute (Swiss TPH) is responsible for evidence generation and dissemination.

Supply Grant

This project is being supported by Medicines for Malaria Venture (MMV) through a Unitaid supply grant that will increase the registration and availability of RAS and evaluate the effectiveness of training material for community health care workers and the community.

Intervention

The project will consist of operational research in select districts in three highly endemic countries (DRC, Nigeria and Uganda). This research will generate evidence on the feasibility of achieving mortality reductions by delivering quality assured RAS through established iCCM platforms using only minimal additional supportive interventions such as improvements to referral systems and networks. The research will also investigate any unintended consequences of the intervention such as inappropriate use of an artemisinin monotherapy without appropriate transition to injectable artesunate followed by ACTs, that could potentially lead to drug resistance. The evidence generated will be used to develop operational guidance for countries looking to scale-up this intervention, and support the planning for scale-up in DRC, Nigeria and Uganda. If the pre-referral intervention is scaled up, Unitaid estimates that RAS could benefit up to a million children and save up to 20,000 lives per year.

Outputs

• • Generate additional evidence on maximizing operational feasibility of pre-referral QA rectal artesunate on suspected severe malaria case fatality rate
  • Identify the minimal requirements of a community case management system to ensure that rectal artesunate is an effective part of a continuum of care from community to a referral facility
  • Identify interventions, if necessary, to avoid the inappropriate use of rectal artesunate as a monotherapy intervention against uncomplicated falciparum malaria
  • Understand and mitigate against potential unintended consequences of scaled implementation, such as adverse drug reactions, unforeseen costs, or unforeseen issues in treatment of malaria at all levels of care.