If detected quickly, an uncomplicated malaria infection can almost always be treated successfully with highly effective oral medicines artemisinin-based combination therapy (ACT); however, if left untreated it can quickly progress to severe malaria, a life-threatening condition that can kill a patient within a few hours. The first point-of-care for many patients with severe malaria is a community-level health-care worker or primary care facility. Patients presenting with severe malaria should be treated as quickly as possible with injectable artesunate (Inj AS); however, most local health posts do not have the drug or personnel trained in its administration, and so patients need to be referred to higher-level facilities. In such cases, WHO recommends the use of RAS as a pre-referral intervention. RAS buys time before Inj AS can be administered – and can mean the difference between life and death.1
With funding from UNITAID, MMV has been working with two Indian pharmaceutical companies, Cipla and Strides Arcolab to obtain WHO prequalification for their RAS products. Reaching a significant milestone in 2015, both companies submitted dossiers for review.
In February 2016, MMV, the US President’s Malaria Initiative, UNICEF, and Médecins Sans Frontières convened a meeting in Nairobi, Kenya, inviting RAS stakeholders from 13 countries to discuss experiences and challenges relating to implementation of this intervention. The recommendations and key findings from the meeting will help countries implement RAS at the community level and save lives. MMV has also begun working with implementing partners and potential host countries to design pilot introduction programmes for RAS.
Dr Jimmy Opigo explains the potential benefits and drawbacks of RAS and the importance of WHO prequalification.
1. How could rectal artesunate improve management of severe malaria in Uganda?
Today, RAS has only been used in a few operational research projects in Uganda, but studies show it leads to better patient outcomes. We still get a large number of children with severe malaria and the first point of contact for care is a Community Health Worker for around 60% of cases. These health workers are voluntary and trained to deliver basic medical care only, so Inj AS would not be possible while RAS would be. As such, in my view, this intervention could have a big impact – it could help to save lots of lives from severe malaria at the community level.
2. What are the advantages of using RAS as a pre-referral intervention?
It’s really a groundbreaking intervention – referral can take a long time with our roads and transport system – we don’t have ambulances. The mother is usually the caregiver and often has other children at home. It can take time to figure out care of the remaining children and how to transport the sick child to hospital. RAS can hold the ground and delay severe disease until children can get recommended treatment
3. Do you have any concerns about the implementation of RAS?
There have been some concerns that RAS could be misused; it is not intended as curative treatment for malaria, and administration of RAS must be followed up with a full recommended course of treatment (such as injectable artesunate and/or ACT). And at the community level, given the challenge of patient transport, a framework will need to be put in place to ensure that referral to higher level facilities does happen.
All medicines can be abused. Good training in ethical conduct and supervision is always a must with a new intervention.
4. What are the advantages of WHO prequalification from your perspective?
It provides reassurance that there is a good manufacturing process and the product has good efficacy. Also, most sources of funding can’t be assigned to a product which is not prequalified and so without it, access to finances and therefore to the medicines, is limited.