Background Information: WHO, UNICEF tackle critical lack of "child size" medicines
Existing paediatric dosage forms for priority diseases
Current dosage forms for the treatment of high burden diseases are often inappropriate for use in children, particularly in resource poor settings (e.g. liquid dosage forms, unpalatable dosage forms, age-inappropriate dosage forms, or dosage forms that are unstable in different environments or temperatures). This results in children being frequently prescribed medicines that are off-label, unlicensed, or that have been manipulated prior to administration. Progress is beginning to be made in this area with some manufacturers developing innovative dosage forms such as flavored dispersible tablets.
The project funded by the Bill & Melinda Gates Foundation will:
Promote research on essential medicines for children by:
- reviewing existing evidence for priority treatments for some diseases in children;
- developing a Model Formulary for children's medicines; and
- developing appropriate standards and capacity for the conduct of clinical trials in children in resource poor settings.
Fill knowledge gaps for priority medicines for children and encourage development of appropriate dosage forms of medicines for children.
Advance access to essential medicines for children by:
- promoting their inclusion in national essential medicines lists, treatment guidelines and procurement schemes;
- working with drug regulatory authorities to expedite regulatory assessment of essential medicines for children; and
- developing measures to monitor and manage their prices; and
Promote improved use of medicines for children by applying established interventions that result in better use of medicines in children.
Beneficiaries of the project
Governments and Regulators will receive clear guidelines, Essential Medicines List for Children, and regulatory recommendations.
Health care practitioners will have guidelines recommending how best to use medicines in children
Manufacturers will have access to clinical trial guidelines, recommended formulations, and Invitations for Expressions of Interest listed by the WHO Prequalification of Medicines Programme.
Families of patients will have improved access to suitable, effective paediatric medicines that are easier to administer.
Children who suffer from illness and disease will receive the medicines they need in an appropriate dosage and formulation, which will aid in adherence and overall health benefits.
Length of the project
The $9.7 million project will be carried out over three years. The project's country level work will focus on Africa and India.
Accomplishments in the area so far
Burden of disease
It is estimated that 36% of the total global disease and injury burden involves children under 15. This disease burden is almost entirely in low and middle income countries. Of the top 20 leading causes of burden of disease in all age groups (according to Disability Life Adjusted Years), at least eight of these relate directly to children, including lower respiratory infections (94.5 million), diarrhoeal diseases (72.8 million), HIV/AIDS (58.5 million), prematurity and low birth weight (44.3 million), birth asphyxia/birth trauma (41.7 million), neonatal infections (40.4 million), tuberculosis (34.2 million), malaria (34.0 million), and congenital anomalies (25.2 million). (Source: World Health Organization. The global burden of disease: 2004 update. 2008. Geneva, World Health Organization. ISBN 978 92 4 156371 0)
Globally, 1000 children under five die every single hour. Over 50% of under-five deaths are due to: acute respiratory infections - pneumonia (17%); diarrhoeal diseases (17%); neonatal severe infections (9%); malaria (7%); and HIV/AIDS (2%). The remaining 50% include measles (4%), non-communicable diseases (4%), injuries (4%), other infectious and parasitic diseases (9%) and other neonatal deaths (27% - including prematurity, birth asphyxia, congenital anomalies).
Millennium Development Goals 4 and 6
Millennium Development Goals 4 and 6 aim to reduce childhood mortality and combat HIV/AIDs, malaria and other diseases. By improving the global access of suitable medicines for children, this project will have a significant impact in the reduction of childhood mortality and morbidity.
The role of WHO
The WHO Department of Essential Medicines and Pharmaceutical Policies (EMP) and a Project Implementation Team involving three other WHO departments will be responsible for project implementation and monitoring. WHO will collaborate with researchers, industry, civil society and UNICEF in delivering essential research of formulations and dosages for children and the development of guidelines for testing, treatment and use of medicines in children.
The role of UNICEF
WHO has worked closely with UNICEF to develop the Model List of Essential Medicines for children and a report on sources and prices of medicines for children. In the project funded by the Bill & Melinda Gates Foundation, UNICEF will participate in the Implementation Team providing guidance and support to ensure effective delivery of project goals.