The World Health Organization (WHO) defines "Health" as a state of complete physical, mental and social wellbeing and not merely absence of disease. In 1975, the World Health Assembly introduced the concept of "essential drugs" (renamed as essential medicines in 2002) and it became part of the popular public health vocabulary. Essential medicines, according to WHO, are those that satisfy the priority health care needs of the population. The WHO expert committee on the selection and use of essential medicines then developed criteria for selecting medicines for essential category and published first model list of essential medicines in 1977. The publication of the WHO first model list of medicines (EML) in 1977, helped to establish the fact that some medicines were more essential than others. Since 1977 the WHO model EML, the essential medicines concept has become a popular tool among many countries. Currently, the EML forms an integral part of national medicines policies in 156 countries, guiding the selection of medicines on the basis of public health relevance, efficacy, safety and cost. The WHO revises the model list once in two years and in the past thirty years, fifteen times revisions in the list has been carried out. The current list is the WHO 15th model EML, published on March 2007.
Essential medicines
According to UNICEF and WHO, the majority of medications worldwide are not formulated for easy or accurate administration to children. The WHO EML is predominantly for adults. It includes some dosage forms for children, but in most cases paediatric formulations do not exist. Once it is available for adults it can be used in children in an off-label way. The use of unlicensed and off-label medicines for children have become common practice for decades.
In October 2007, World Health Organization published the first model list of essential medicines for children that specifies proper dosages and formulations for their smaller, constantly-changing bodies. It becomes the first list to address the diseases of children in the developing countries. The birth of first essential medicine list for children (EMLc) 2007 has reaffirmed the principle that children cannot be considered as little adults in relation to medicines.
Some facts on children and medicines
(Source: UNICEF and WHO)
1 Children differ in the way they ingest, absorb, metabolize and excrete drugs, and behavioural and developmental issues complicate their treatment.
2 As an unsafe alternative to missing paediatric formulations, 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.
3 An estimated 10 million children die every year, many from diarrhoea, malaria, respiratory tract infection, pneumonia or HIV/AIDS. Medicines for these illnesses exist, but paediatric formulations and knowledge on how best to use them in children are often lacking.
4 There is little knowledge about the effects certain medicines can have on children. This is partly due to the fact that fewer clinical trials are conducted in children than in adults.
5 Certain diseases are common in childhood, such as meningitis, pneumonia, ear and respiratory infections, and gastrointestinal infections.
WHO first model EMLc:
The first model list for children is based on the 15th WHO model EML. The format, category, section and numbering of the 15th WHO EML have been retained. Some categories (sections) and subsections have been deleted. Some individual medicines in the particular section are also deleted. The number of medicines selected for the EMLc is 257 in contrast to 340 in the 15th model EML. The EMLc is intended for use for children up to 12 years of age. The first EMLc, as in parent EML, is composed of a core list and complimentary list. The core list is a "list of minimum medicine requirements for a basic healthcare system". The complimentary list contains "essential medicines for priority diseases, for which specialized facilities / or training are needed". The square box symbol is used on 36 medicines in the EMLc. In addition two additional symbols are used. One is an age restriction symbol (letter 'a' in a box) and the other one is a review symbol (letter 'R' in a box). The age restriction symbol before a medicine indicates that there is an age restriction on use of that medicine. For example, doxycycline should be used for children of more than 8 years age and diloxanide more than 25 kg weight. The review symbol before a medicine or a category of medicines indicates that a review is needed to confirm the efficacy and safety, or to expand its use to additional age groups. There are 21 medicines in age restriction category and 36 individual medicines along with 27 categories of medicines are under review category.
Medicines for children have received a great deal of attention in recent years. Although a few developed countries have already their own medicines list for children, the first model EMLc would be the first for the children of the developing countries. The experts in various developed countries have been advocating development of medicines for children based on paediatric experience. In January 2007, legislation came into force in the European Union with respect to medicinal products for paediatric use. UNICEF has proposed a comprehensive plan to promote the development of paediatric medicines. The objectives are straightforward that the paediatric medicines are affordable, child size, palatable and safe. The publication of first EMLc is the first step toward providing right medicines to the children in the third world countries.
(The author is Reader in Pharmacy, Annamalai University, Annamalainagar 608 002 (TN)