UEMO Recommendation on Medecines’ use in Children and Young People

07/06/2008 Policy2 2106 Views

The advances in paediatric knowledge and young people’s awareness of health issues, the amelioration of diagnostic tools and the increasing number and quality of diagnostic technologies in children and young people has lead to the growing use of medicines in these age groups. Following the aspiration to well- being promoted by the World Health Organization, doctors have an ever growing need to use medicines.

Only recently, has testing of medicines in children and young adults been subject to specific rules (1).

In this Situation many medicines have been used off label (2) or on the assumption that simply making a proportionate reduction in the adult dose is feasible. This is not necessarily either safe or appropriate. Off label prescribing for children leaves children exposed to potential danger and prescribers to potential liability. There is a clear need for more research evaluation of the use of medicines in children (3).

Children’s medicines are often not licensed particularly in smaller countries because of bureaucratic disincentives and lack of relevant research. To overcome this problem, UEMO proposes pan-European licensing for children’s medicines.

At present the use of medicines in children and young people is not yet guided by sufficient knowledge of efficacy and safety (1, 2). In fact, much of the information on safety is based on industry’s periodic reports anecdotal papers and pharmacovigilance notifications. The assumption that clinical indications are similar to those for adults must be carefully considered and weighted. In future pharmacovigilance should include direct notification of possible adverse effects by prescribers, parents and, when appropriate, children themselves.

In the light of these facts, the practical knowledge of doctors working in general practice/family medicine in these matters should be driven from officially published information so that legal and ethical problems can be minimised. Such information should be made more widely available and all countries should provide a recommended children’s formulary.

In particular UEMO wishes to state the importance of programs like those of the European Medicines Evaluation Agency EMEA, which can be seen at http://www.emea.europa.eu/htms/human/pediatrics/pips.htm  and exhorts all general practitioners/family doctors to participate in these and also to maximize their role in local pharmacovigilance programs.

1 – Steinbrock R, Health Policy Report – Testing Medications in Children; N Engl J Med 2002; 347(18):1462-1470).

2-Evidence-based prescribing – BMA Board of science 2007, London ; 8-9)

3 – Wood AJJ Developmental Pharmacology – drug disposition, action, and therapy in infants and children; N Engl J Med 2003; 349(12):1157-1165)

Bergen, 7 June 2008

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