Rectal artesunate listed as essential medicine

16 Jun 2017

On the International Day of African Child on 16 June 2017 in Geneva, artesunate rectal suppositories (100mg) for the pre-referral management of severe malaria in young children was included on the World Health Organization’s Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc).

WHO’s Model EML[1] identifies medicines that “satisfy the priority health care needs of the population.” In practical terms, the WHO Model EML can help countries consider revisions to their national EMLs, which in turn inform the procurement decisions of central medical stores and the prioritization of medicines for use in-country.

With concerted global effort, malaria incidence and deaths fell dramatically between 2001 and 2015: it is estimated that of the 6.2 million lives saved from malaria over that period, 5.9 million (95%) were those of children under the age of 5 years. Despite this significant gain, in 2016 malaria took an estimated 429,000 lives, 306,000 of whom were young children. Inclusion of rectal artesunate (RAS) 100mg into the EML helps ensure that this child-friendly severe malaria intervention may be more accessible for those who need it most.

Information on Rectal Artesunate Suppositories

Rectal artesunate suppositories for the pre-referral management of severe malaria are intended for infants and children who are critically ill and unable to take oral medicines. Untreated severe malaria can be fatal, especially in the first 24 hours; but this risk can fall to 10-20% with prompt treatment and care.[2] In many malaria-endemic countries, treatment delays due to distance from health facilities can result in fatal outcomes. The WHO recommends pre-referral administration of RAS in young children[3] to reduce the risk of death or permanent disability,[4] based on a study completed by WHO TDR that showed a 50% reduction in disability and death in children < 6 years, living 6 hours from a referral centre who were given artesunate suppositories as a pre-referral treatment.[5]

WHO's EML has listed 50 mg and 200 mg strength RAS since 2007. MMV and its partner Cipla have now developed a 100mg RAS and this product has been approved for purchase with donor funds (via Global Fund’s Expert Review Panel (ERP) product list, while WHO prequalification review is ongoing). In addition, Strides Shasun’s 100 mg RAS product is currently undergoing review by the WHO prequalification programme.

Information on the Essential Medicine’s List

WHO reviews EML dossier applications and evaluates medicines based on their relevance for public health needs, while also considering evidence on efficacy, safety and cost-effectiveness. Revised every 2 years, the EML (now in its 20th edition) and the Essential Medicines List for Children (EMLc – in its 6th edition) is intended to help countries decide which medicines should be “available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.”[6]