Malaria

Selection of safe and effective quality antimalarial medicines

The importance of high-quality antimalarial medicines cannot be overstated; they are the cornerstone of malaria treatment and their availability must be ensured. Poor quality medicines not only adversely affect the health and lives of patients, but also damage the credibility of health-care programmes, and increase the burden on health systems.

WHO recommendations

Antimalarial medicines should be selected for procurement based on the WHO guidelines for the treatment of malaria, or the WHO model list of essential medicines. Fixed-dose combination formulations are strongly preferred and recommended over co-blistered, co-packaged or loose tablet combinations, since they facilitate adherence to treatment and reduce the risk of taking the medicines as monotherapy, which contributes to the development of drug resistance.

Quality assurance of ACTs

Quality assurance of artemisinin-based combination therapies (ACTs) is particularly important. Artemisinin-based medicines are difficult to manufacture and co-formulate with other compounds, and they are susceptible to degradation by high temperatures and humidity. Ensuring adequate quality of manufacturing, transport and storage is therefore critical.

The WHO Prequalification Programme (WHO/PQP) evaluates the quality of specific medicinal products based on the review of product dossiers submitted by the manufacturing company and inspection of the manufacturing facilities. The latest list of WHO-prequalified antimalarial medicines is publicly available on the WHO/PQP’s website.

Recommended procurement practices

In 2010, WHO published the WHO good procurement practices for artemisinin-based antimalarial medicines, a practical manual providing guidance on the selection and procurement of safe and effective artemisinin-based antimalarial medicines that meet international quality standards. Through a concise 16-step checklist, the manual covers all aspects of the procurement cycle, putting special emphasis on model product specifications and the evaluation of product quality.

The model specifications include technical requirements based on stringent norms and standards of safety, efficacy, quality, packaging and labelling among others, and can be used as a general technical guide for procurement officers in the preparation of tenders for procurement. Procurement entities should request manufacturers to supply documentation demonstrating that their products comply with the standards of the WHO/PQP or another stringent regulatory authority.

Compliance with Good Manufacturing Practice is also an important consideration for procurement agencies in the procurement of antimalarial medicines, but not all Good Manufacturing Practice certificates reflect the same standards of control of manufacturing processes.

Procurement entities play a key role in ensuring the selection of safe, effective, quality products by monitoring and evaluating quality at each step of the procurement cycle, including through pre-shipment or post-shipment quality control. Given that a significant proportion of medicines are being supplied through private sector providers of health care, working closely with the private sector is critical to improving the availability of quality-assured antimalarials and their rational use.

Last updated: 25 March 2014

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