Italian Medicines Agency Agenzia Italiana del Farmaco

Medicines and pediatrics (2014)

AIFA communication campaign 'Medicines and pediatrics'

The Italian Medicines Agency, in compliance with its institutional mandate, intends to carry out a communication campaign on the use of medicines in the pediatric age. It is a large-scale scientific and social project that aims to disseminate certified and correct information on the use of drugs and to guide prescribing choices in the name of appropriateness.

The need to raise awareness of the responsible and informed use of medicines in pediatrics is particularly felt by the dedicated learned societies which have also highlighted the importance of promoting clinical trials in the pediatric field.

The pediatric population is, in fact, scarcely investigated as regards a rational use of the drugs intended for it. It follows that very often, in the absence of data from specific clinical studies, medicines that are actually authorized for adults are used in children, but at lower doses. In practice, the child is considered as a small adult. But this exposes you to risks, because not all drugs used in the pediatric field have the same identical response in infants, children and adolescents, due to the differences in their metabolization and absorption and the different growth processes. Therefore, upon administration, the choice of medicines and their respective dosages should be carefully considered and evaluated according to the age of the young patients.


The campaign aims to:

  • Promote the correct use of drugs in the pediatric age by raising awareness of both the general population and healthcare professionals on the possible risks arising from the administration to children and adolescents of drugs authorized for use in adults;
  • Make parents and doctors aware that the use of medicines not specifically approved for pediatric age is "off-label" (i.e., outside the approved therapeutic indications) and that it can potentially generate problems in young patients;
  • Inform and make the general population aware of the different ways of absorbing and metabolizing drugs in different periods of growth;
  • Inform and make doctors and citizens aware of the importance of reporting the effects of drugs administered in children;
  • Disseminate more information to doctors and families about the added value of clinical studies conducted in the pediatric population to improve the quality and ensure the safety of pediatric medicines.


The communication campaign is aimed at both the general population, with particular regard to young families and women, recognized as the main persons responsible for administering drugs within the family unit, and healthcare professionals.


The communication campaign aims to define three main messages:

1 - The child is not a small adult

An important concept to spread, able to highlight the specificity of the pediatric subject compared to the adult in the response to drug treatment. The communicative content in question will try to raise higher awareness of the mistakes made when administering medicines to children such as, for example, the reduction of the doses of a medicine commonly used for adults, arbitrarily adjusted according to the body weight and age of the child.

The message will underline how do-it-yourself, word of mouth or the use of web sources are absolutely to be avoided, since each medicine must be administered after appropriate consultation and control of the doctor. Moreover, it is necessary to draw attention to a correct reading of the package leaflet and to compliance with the doses and indications provided, in order to avoid any mistakes in therapy such as the risk of overdose.

Both parents and doctors need to be aware that administering a drug with dosages, indications and formulations not specifically approved for the pediatric age involves an off-label use of the medicine.

2 - Infants and adolescents: different ages, different drugs and doses

Infants and adolescents have very different drug absorption capacities from each other: the former, due to an accelerated growth process, have much faster metabolization times, while the others require careful and measured dosages in relation to the metabolic processes related to pubertal development. It is therefore essential to take these characteristics into account when choosing medicines and the relative doses of administration, which shall be carefully evaluated according to different ages.

3 - Pediatric drug studies: the value of research for the benefit of young patients

Despite the progress made in the last forty years by research in clinical pharmacology applied to pediatrics, the problem of the availability of drugs suitable for children has not yet been solved.

Overall, the percentage of pediatric drugs on which trials have been carried out is still lower than 50%: this means off-label use in children, i.e., with dosages, indications and formulations not specifically tested for the pediatric age.

It is necessary to make it clear that the voluntary participation of children and adolescents in clinical trials contributes to filling the lack of data, thus guaranteeing greater quality, safety and efficacy of the drugs intended for the pediatric age.


The messages described above will be conveyed through both television and radio broadcasting channels and by resorting to press campaigns, billboards, dynamic urban advertising and awareness-raising actions on social media.

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