Results from the EMEA's survey in to the extent of medicinal product use in children in Europe show that off-label use of prescription drugs and unauthorised medicinal products is "widespread".
The Paediatric Committee of the EMEA conducted a retrospective survey with the aim of collecting "all existing uses of medicinal products in the paediatric population". They wanted off-label and unauthorised use to be included, in order to get a fair representation of the data. The report lists all the data that was submitted by the different member states and includes information on the extent and quality of the data.
The researchers found that a variety of medications* are being used off-label or without marketing authorisation in the paediatric community. They say that the widespread use of off-label drugs is due to the "lack of age-appropriate formulations" and identified that further clinical trials in a number of therapeutic areas are needed, particularly in preterm and full-term neonates.
The data provided by many countries were scarce, say the researchers. They also identified a number of limitations with the data such as a "lack of common terminology in the different European Countries" for the different drug uses. Overall, they say that they have provided an overview of the unmet medical needs and have shed "further light on the still unsatisfactory situation of the treatment of European children".
* drug classes included antiarrhythmics, antihypertensives, proton pump inhibitors and H2-receptor antagonists, antiasthmatics, antidepressants, contraceptives and antibiotics
[Reference]
1. European Medicines Agency.Report on the survey of all paediatric uses of medicinal products in Europe: executive summary. Internet Document: [2 pages], 6 Jan 2011. Available from: URL: http://www.ema.europa.eu. .
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