Procuring supplies for children
Zinc Supplementation
Evidence for the safety and efficacy of zinc supplementation in the management of diarrhoea
A document prepared by the Department of Child and Adolescent Health and Development of the World Health Organization (WHO) and by the Supply Division of the United Nations Children's Fund (UNICEF)
Following the publication in 2004 of the WHO/UNICEF joint statement on the clinical management of acute diarrhoea (1), recommending the use of zinc in the clinical management of acute diarrhoea, efforts to ensure the availability and use of suitable zinc products in countries were conducted by WHO, UNICEF, USAID and Johns Hopkins University. In 2005, a collaborative effort with the United States Pharmacopoeia (USP) helped establish monographs and reference standards for tablets and oral solutions, and led to the development of a document entitled Production of zinc tablets and zinc oral solutions: guidelines for programme managers and pharmaceutical manufacturers (2). In addition, evidence on the efficacy and safety of zinc in the management of acute diarrhoea was collated and presented to the WHO Expert Committee on the Use of Essential Medicines in March 2005 to support the inclusion of zinc in the 14th revised edition of the WHO Model List of Essential Medicines in March 2005 (3). At the same time, UNICEF Supply Division identified international suppliers of zinc products that met the established quality criteria of the USP monograph and fulfilled the WHO criteria of good manufacturing practice. In May 2006, an international competitive tender was issued, to which seven zinc product manufacturers from four countries responded. Following thorough technical evaluation, including laboratory analysis of samples at the USP Laboratories in Washington, DC, one supplier based in France (Nutriset), under manufacturing contract with Laboratoires Pharmaceutiques Rodael, was approved to supply zinc dispersible tablets (20 mg) to UNICEF. Efforts are now continuing to approve the products of other manufacturers.
Over the last two years, with zinc treatment for the management of acute diarrhoea being included in the policies of more and more countries, some practical issues concerning the supply chain have emerged, including difficulties with product registration in countries.
A document jointly prepared by WHO and UNICEF will soon be released, collating a summary of current scientific evidence demonstrating the safety and efficacy of zinc treatment in the management of acute diarrhoea, in order to support applications for the registration of zinc in countries for that purpose.
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