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Medicines: medicines for children

Fact sheet N°341
June 2010

Key facts

  • Nearly nine million children under five years old die every year, many of them from conditions that could be treated with safe, effective medicines.
  • Children are not small adults, their bodies respond to medicines differently. They need medicines tailored to their age, body weight and physiological condition.
  • Few medicines exist in formulations developed specifically for children.
  • Worldwide many medicines for children are used "off-label", that is their effects on children have not been studied and they are not licensed for use in children.
  • Flexible solid oral dosage forms of medicines are ideal for children.

The ideal children's medicine is one that suits the age, physiological condition and body weight of the child taking them and is available in a flexible solid oral dosage form that can be taken whole, dissolved in a variety of liquids, or sprinkled on foods, making it easier for children to take.

Global situation and challenges

Nearly nine million children under the age of five die every year, many of them from conditions that could be treated with safe, effective medicines. Access to appropriate medicines for children is essential for achieving the child health goals including Millennium Development Goals (MDG) 4 (Reduce child mortality by two thirds) and MDG 6 (Combat HIV/AIDS, malaria, and other major diseases).

Lack of medicines for children is a global problem, which most acutely affects developing countries. Worldwide many medicines for children are used "off-label", that is their effects on children have not been studied and they are not licensed for use in children.

Very few medicines exist in formulations developed specifically for children and those that do often do not reach the children that need them most. For example, nearly three million children under five die each year from diarrhoea and pneumonia. In the case of diarrhoea, reliable treatment exists in the form of oral rehydration salts and zinc. Yet, studies show that this treatment is frequently unavailable in pharmacies and clinics in countries where these diseases are most common. Improved access to this medicine could save millions of lives.

When child specific medicines are not available, healthcare workers and parents often use fractions of adult dosage forms or prepare doses of medicines for children by crushing tablets or dissolving portions of capsules in water. This practice is difficult for the parent or care-giver, can be hard for the child to take and can result in inaccurate administration of the medicine with either under or over dosing the child, leading to possible adverse reactions or unsuccessful treatment.

Children with chronic conditions, such as HIV/AIDS, may have to take several medicines daily. For them, fixed-dose combination products–several medicines in one pill–are best. However, very few fixed-dose combinations for children exist.

Some regional and national regulatory authorities including the European Medicines Agency and the United States' Food and Drug Administration have undertaken initiatives to improve the availability, safety and efficacy of medicines for children. Ongoing global effort is needed to improve the situation.

Areas where more work is needed


Many essential medicines do not exist in child-size dosage forms. As well, for many medicines there is not enough information about their efficacy and safety to allow them to be licensed for use in children. In order to address the research needs for children's medicines, strengthening the quality and quantity of paediatric clinical trials research is essential. Clinical trials involving children require careful ethical review and approval.


Promoting the need for flexible solid oral dosage forms and fixed-dose combinations for children is required. Pharmaceutical companies interested in manufacturing of children's dosage forms need to be identified and encouraged to produce medicines for priority conditions e.g. fixed dose combinations for malaria, HIV/AIDS and tuberculosis, as well as antibiotics for neonatal infections. Health care workers and carers of children need to expect 'preferred dosage forms'.

A first step in promoting access is to assess the current situation concerning the availability and costs of essential medicines for children. Once an assessment has been made it will be possible to advocate for changes that will benefit children and their families and lead to measurable improvements in health outcomes.

WHO response

  • Launching the 'Make medicines child size' initiative in December 2007 raised awareness and stimulated action to improve the availability of safe, effective, quality medicines for children including regulatory measures, government policy, procurement agency purchasing decisions, research from academia and private sector, and production from the pharmaceutical industry.
  • Providing the healthcare, procurement and pharmaceutical communities with information on dosage and treatment guidelines through the development of the WHO Model Formulary for Children containing independent prescriber information on over 240 medicines based on the WHO Model List of Essential Medicines for Children, first developed in 2007 and reviewed and updated every two years.
  • Advising countries on issues of quality, safety, efficacy, supply management and promoting access to essential medicines for children in countries. This is done by encouraging the inclusion of medicines for children in national essential medicines lists, treatment guidelines and procurement schemes and working with national drug regulatory authorities to expedite regulatory assessment of essential medicines for children.
  • Creating an online clinical trial registry for clinical trials involving children and developing guidelines for conducting clinical trials in children in resource-limited settings.
  • Establishing the Paediatric medicines Regulatory Network (PmRN), a network of regulatory authorities to work on how best to license medicines for children.
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