# \[e-drug\] Children need better medicines **URL:** \ **Category:** e-drug\ **Created:** [January 14, 2009, 8:55pm UTC](https://talk.edrugplus.org/t/e-drug-children-need-better-medicines/31120 "2009-01-14T20:55:30Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![edp](https://avatars.discourse-cdn.com/v4/letter/e/ea5d25/32.png) [@edp](https://talk.edrugplus.org/u/edp)\ **Post date:** [January 14, 2009, 8:55pm UTC](https://talk.edrugplus.org/t/e-drug-children-need-better-medicines/31120/1 "2009-01-14T20:55:30Z")
E-DRUG: Children need better medicines -------------------------------- [This message was written by Philippa as a briefing document for civil society and NGOs. WB] Children need better medicines This briefing identifies gaps that exist in the provision of medicines for children and outlines key challenges and solutions. What are the problems? Medicines for children are frequently unavailable, impractical to administer or difficult to use well, and unsafe and unaffordable. Action is needed to ensure children's medicines meet the standards expected for medicines available to adults. All children are affected, but the impact is most acute and the needs most urgent in poor countries, where the proportion of children in the population is highest and health services are weakest. Four challenges require attention in the short-term: absence of scientific data; lack of products that are practical to administer; lack of usable information about existing medicines; and market failure for paediatric medicines. Absence of scientific data Scientific evidence is essential to ensure appropriate use and access to medicines for children. Fewer than half the products used to treat children have been properly developed. Pharmacokinetic studies defining optimal doses for children in relation to age or weight are often not done. Much of the treatment offered to children lacks a scientific basis, i.e. is 'off-label', and estimation of doses and treatment effects are based on studies in adults. This wrongly assumes that children metabolise medicines in the same way as adults without taking account of maturity of the liver, kidneys and enzyme systems. The result can be under- or over-dosing, leading to inefficacy or toxicity. Insufficient appropriate dosage forms Medicines are needed in forms that are appropriate for use in household and clinical settings. In addition to being available and affordable, paediatric medicines must be palatable and acceptable to the child, stable and practical to use in difficult conditions, packaged appropriately, and accompanied by information that parents can understand and use. Many are now unpleasant to taste, difficult to administer, and costly. In some diseases several drugs have to be taken, making fixed-dose combinations a practical solution. Impractical dosage forms result in inefficiencies in busy clinical settings, waste money and have poor health outcomes. Weak pharmaceutical markets for paediatric products Without scientific data, the registration of products in countries is inhibited. Weak competition among available products leads to high prices. In the absence of suitable products, there is no real demand and new manufacturers are reluctant to enter the market. Why has this situation arisen? The difference in standards for children's and adults' medicines stems partly from the perceived risks of conducting studies in children. There has been lack of demand for appropriate medicines and information. Higher expectations have resulted from recent developments including: the new paediatric medicines' legislation in the European Union (2007) ; identification of essential medicines for children - the WHO Essential Medicines List for Children (EMLc 2007); and pressure from AIDS, tuberculosis and malaria public health programmes. What are the priorities for better products? For better products, more research and development of medicines is needed. Globally 1000 children under five die every hour. HIV/AIDS, TB, malaria, neonatal sepsis, pneumonia and diarrhoea cause most of these deaths and serious illness. Products appropriate for children in all age-groups are needed to treat these diseases, including: . appropriately packaged antibiotics to treat pneumonia and neonatal sepsis; . a palatable and easily used formulation of zinc in combination with Oral Rehydration Salts for treating diarrhoea; . effective pain relief; in many countries access to simple oral morphine is denied; . new fixed-dose combination medicines for tuberculosis in children; . better dosage forms of existing products, including fixed-dose combinations for malaria and HIV/AIDS; and . more easily administered dosage forms - such as sprinkles, small or scored tablets, drops etc. Support is needed Progress on WHO's World Health Assembly Resolution 60.20 "Better Medicines for Children" will be reported to the 2009 WHO Executive Board in January 2009. WHO has developed and updated the Essential medicines List for Children, commissioned work to identify ideal fixed-dose combination products for tuberculosis, undertaken preliminary surveys of availability of key medicines for children in Africa, and begun to define the optimal dosage forms of medicines suitable for children of all ages. This work provides a framework for global support for better research into children's medicines, which if implemented will enable progress toward MDG targets. It is now necessary for the entire public health community - governments, donor agencies, academic research units, regulators, the industry and all who have a duty to care for children - to recognize the need for safe and appropriate medicines for this population. A start has been made, but without sustained commitment by all concerned during 2009 (the year of the Rights of the Child) and beyond children will continue to be disenfranchised: their rights to adequate healthcare, as well as the global agenda for health, will be undermined. It is time for action. Regards Philippa Saunders Independent consultant UK EDP@GN.APC.ORG