the Better Medicines for Children Project, which is undertaken by the World Health Organization (WHO) Department of Pharmaceutical Policy and Essential Medicines. WHO has had an Essential Medicines List (EML) since 1977, but in 2002 the list became much more rigorously evidenced-based. Medicines get on the list based on health care need and data on their efficacy and safety. The list is used by many countries to help them procure medicines at favorable prices and then launch an essential medicines program.
The Better Medicines for Children Program was launched in 2007. The program raises many of the issues discussed at the workshop thus far. There is a persistent need for more research on medicines for children, since many of the top causes of death among children under five can be cured or ameliorated by medicine. Wider availability of essential medicines would help make a big dent in childhood mortality. The WHO launched the first Essential Medicines List for Children in 2007. Even with the existence of the list, there can still be problems with regard to the supply chain and misuse. In addition, many medicines actually prescribed to children are not effective at all.
According to Dr. Bero, zinc sulfate, which is used to treat diarrhea, illustrates some of the barriers to getting medicines to children in developing countries. In addition to having an EML that includes zinc sulfate, the appropriate dosage form must be available. For low income settings, this would need to be a dissolvable tablet. At this time there is only one manufacturer of this form of the medicine. The medicine has to be registered in the country, which may involve local research (not necessarily local clinical trials). It must be procurable at a reasonable cost. There must be clinical guidelines and an implementation strategy. Parents must be willing to use the medicine and children must be willing to take it. Zinc does not taste good, and taste formulation can be culture specific.
From the above, it is clear that there is a real need for research in developing countries related to medicines for children. The EML for Children Committee’s recommendations put a high priority on pharmacokinetics studies (research on what the body does to the drug), particularly in neonates (newborn infants). Examples include research on the effects of malnutrition on pharmacokinetics, dosage, and the timing of drug administration in relation to food intake. According to Dr Bero, there is not a good research base in these areas today.
One of the projects within the WHO Better Medicines for Children Program is to develop reporting standards for clinical trials in children and regulatory standards for new drugs and formulations. Part of this involved