Disease Prevention and Control / Communicable Diseases / Malaria
Specifications for Prepackaging Antimalarial Medicines:
Report of a WHO Technical Consultation
Full Text (28 pp, PDF)
Held in Geneva, Switzerland, from 2 to 4 September 2003.
Establishing minimum standards for prepackaging antimalarial medicines, as follows:
Early diagnosis and prompt treatment with effective antimalarial medicines is the only lifesaving intervention for people afflicted with malaria. The effectiveness of treatment with antimalarial medicines is, however, threatened by the growing resistance of falciparum malaria to chloroquine and sulfadoxine-pyrimethamine, which were once effective against the disease.
As part of a global strategy to delay the rapid development of the parasite's resistance to antimalarial medicines and to enhance the efficacy of treatment with antimalarial medicines, the World Health Organization (WHO) recommends that antimalarial medicines should always be used in combination, preferably with an artemisinin partner—a treatment known as artemisinin-based combination therapy (ACT). The Roll Back Malaria (RBM) global initiative has set a target of reducing malaria mortality by 50% by 2010, and the early diagnosis and prompt treatment of the disease with effective antimalarial medicines are fundamental components of this strategy.
Even in settings where effective treatment policies are in place, patients' non-adherence to the prescribed therapeutic dose and to treatment schedules poses a serious challenge to effective disease management. The prepackaging of treatment courses that are stratified into age or weight groups has greatly contributed towards enhancing the rational use of medicines1.
Prepackaged treatment courses are of particular importance in the treatment of malaria, as the disease is commonly managed without contact with a health worker. The strategy of prepackaging treatment courses has even greater relevance to combination therapy for the treatment of malaria, which requires that the individual medicines are co-packaged in a user-friendly way to optimize their use2.
Antimalarial combination medicines are relatively new products with which many manufacturers, regulatory authorities and health-care professionals have limited experience. It is expected that, as the demand for artemisinin-based combination therapies increases, there will be a corresponding increase in the generic sources of these medicines. An overview of existing combination therapies shows that an array of products is already on the market in Africa and Asia, although such products conform to varying standards with regard to their packaging and the patient information provided.
These changes have made it essential to establish minimum required standards for the prepackaging of antimalarial medicines. The main objective of these guidelines is to assist ministries of health and malaria control programmes in their assessment of different prepackaged antimalarial products. The guidelines will, however, also provide guidance to manufacturers in meeting the basic requirements for prepackaging antimalarial medicines. They are not intended to replace the standard guidelines on packaging for pharmaceutical products, published as an annex to the thirty-sixth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations3.
The technical consultation took the form of presentations of prepared papers, followed by plenary and group discussions, on the basis of which specific conclusions were reached and recommendations were made. The proceedings of the meeting and working papers form the basis of this report.
1 Ansah EK et al. Improving adherence to malaria treatment for children: the use of prepacked chloroquine tablets vs. chloroquine syrup. Tropical Medicine and International Health, 2001, 6 (7): 496–504.