WHO, UNICEF tackle critical
lack of 'child size' medicines
by the World Health Organization

The World Health Organization (WHO) has received a $9.7 million grant from the Bill & Melinda Gates Foundation to work with UNICEF to conduct crucial research in children’s medicines, with the aim of increasing the number of 'child size' medicines designed and formulated specifically for children.

Currently, many medicines are only designed for adults. More than 50 percent of medicines prescribed for children have either not been developed specifically for children or have not been proven to be effective and safe for their use. Therefore many children lack access to essential treatment because no suitable pediatric dosage or formulation of the necessary medicine exists, or those that do exist are not available or are too expensive.

"We must take the guess work out of medicines for children," said Carissa Etienne, Assistant Director-General, WHO. "Children are suffering and dying from diseases we can treat, and yet we lack the critical evidence needed to deliver appropriate, effective, affordable medicines that might save them.”

As an unsafe alternative to missing pediatric medicines, healthcare workers and parents often use fractions of adult dosage forms or prepare makeshift prescriptions of medicines by crushing tablets or dissolving portions of capsules in water. Other challenges include the need for more clinical trials and research to be carried out on pediatric medicines.

"Some progress has been made on children's medicines but too many medicines are still given to children that have never been properly tested for them," said Dr. Hans Hogerzeil, Director of Essential Medicines and Pharmaceutical Policies, WHO. "This work is an excellent example of coordination of United Nations agencies and key experts in the world to address this urgent problem."

The grant provides support for essential research to: determine the optimum dosage forms for pediatric medicines (e.g. small tablets, dispersible tablets, powders); develop dosing guides (e.g. a review of existing priority medicines and the identification of the appropriate doses for new medicines for children); and develop guidelines for testing, treatment and use of medicines in children, including guidelines on conducting clinical trials in children.

Globally, 1000 children under the age of five die every hour. Diarrheal diseases account for 17 percent of these deaths. The optimal treatment for diarrhea is zinc with oral rehydration salts. Yet, in a recent study of health facilities zinc was the least available of all pediatric medicines. And when zinc is available, it is not licensed as a treatment to reduce diarrhea --- leaving pharmacists to concoct doses --- and it is both unpleasant tasting and difficult to administer. To reduce child mortality in this area, easy to use, palatable and appropriate dosages are needed.

"The Bill & Melinda Gates Foundation grant will contribute to accelerating work on investigating, clarifying and communicating to partners, including industry, what the needs of children are in terms of medicines and dosages to more effectively fight child morbidity and mortality,” Hanne Bak Pedersen, Deputy-Director UNICEF Supply Division, said. “UNICEF is very pleased to be working with WHO on this project and appreciates the support from the Gates Foundation.”

Another major cause of under-five mortality is pneumonia, leading to 17 percent of deaths each year. Effective treatment of pneumonia requires 50mg of amoxicillin per kilogram of child's weight per day for three to five days. An easy to use package of oral amoxicillin providing the appropriate dose would ensure the right course of medicine is taken, and thus help reduce child mortality.

"Improving essential medicines for children is a critical global health issue,” added Jaime Sepulveda, Director of Integrated Health Solutions Development, Bill & Melinda Gates Foundation. "This program will help provide effective health interventions to children and improve child survival, particularly in the world’s poorest countries.

This work follows the WHO-led "make medicines child size" initiative launched in December 2007, which focuses on improving access to better medicines for children. The topic of children’s medicines will be discussed at the WHO Executive Board meeting in January 2009.