Report of an Informal Consultation on Missing Priority Medicines for Children. 14‐15 July 2011, WHO HQ, Geneva, Switzerland
(2011; 22 pages)

On 14-15 July 2011, an informal consultation was convened to discuss strategies for advancing the availability of a fixed-dose combination (FDC) medicine for treatment of paediatric tuberculosis (TB). While the primary focus was first-line therapies, second-line treatments were also discussed. The meeting was held at the World Health Organization (WHO) headquarters in Geneva, coordinated by the Medicines Access and Rational Use (MAR) unit. Participants included representatives from WHO, academic institutions, nongovernmental organizations, pharmaceutical industry associations, procurement organizations, regulatory agencies, and funder agencies.

While FDCs exist for treating paediatric TB, the available products are based on outdated dosing guidelines. Because these existing formulations are significantly different from current dosing recommendations, it is too complicated to use the products as a long-term solution. Specifically, the ratios of individual medicine components in the existing FDCs do not correspond to those in the revised dosing recommendations. It is overly complicated, and in some cases impossible, to use them and achieve correct dosing. Other options, such as splitting or crushing adult strength tablets as a means of delivering correct doses, are also unrealistic as long term solutions, particularly because of poor compliance and risk of dosing errors. Policies and scientific evidence of the need for a revised FDC are clear, yet progress towards a revised product has been slow...

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