Background Doses for children used to be derived by scaling from adult dosages using bodyweight as a reference. Administering a drug at a dose or a frequency, or by a route other than those approved, renders it an off-label use. Clinical trials usually focus on the adult population, so consequently there are limited or no paediatric documentation with respect to many approved drugs. Use of off-label drugs is a transversal problem in health systems and studies in LATAM related to the prevalence of the prescription of drugs with no approved indication are developing.

Some studies show inconclusive developing results of prevalence (17% to 60%) of off-label use of drugs in paediatric populations.

Purpose The purpose of this study was to determine trends in prescription and use of off-label drugs in children at a high complexity hospital.

Material and methods A descriptive observational study with retrospective data was developed. A sample of 299 inpatient paediatric clinical records were analysed during 2015 and the drugs were divided into two categories according to coverage or not coverage of the health care system. The study focused on those drugs with off-label use that are not included in the health care system’s basic coverage.

Results A sample of 299 clinical records found that the proportion of use of off-label drugs in children was 20.9%, paediatric intensivists (47.2%) and paediatricians (41.6%). The major prescribers, the drugs and their pharmacological category with off-label use were characterised and the cost of these treatments were determined. In 125 treatments, physicians used off-label drugs

Cefuroxime (73.6%) and dexmedetomidine (17%) were the most off-label prescribed drugs. Costs of the off-label drugs used were €24.907.

Conclusion Prescription of off-label drugs represents an ethical and legal implication for physicians. Clinical practice guidelines in some cases included off-label uses for some drugs. This situation should be evaluated. Children are not ‘small adults’ and only a few drugs are licensed for this population. This is a daily challenge for physicians.

This study should be the first of more in LATAM related to this topic.

References and/or Acknowledgements I am very grateful to Javeriana University.

No conflict of interest