Off-label drug use in neonates and infants in Spain: A five-year observational study

Abstract

Objectives: To provide information about the off-label rate of all drug prescriptions in</p><p>neonates and infants up to 1 year in Spain. Also, to analyse the off-label prescription of</p><p>medicines under current practice in this age group according to different evidence</p><p>sources.</p><p>Study design: A five-year (2015–2019) exploratory observational study about off-label</p><p>prescription in neonates and infants (0 to 1 year) at primary health care in Spain. All drug</p><p>prescriptions in this age group were analysed and classified according to their labelling in</p><p>off-label or on-label. The drugs prescribed off-label were subsequently reviewed in</p><p>national formularies and other databases to assess its evidence of use beyond what is</p><p>recommended in the Summary of Product Characteristics (SmPC).</p><p>Results: On average 34.50% of total prescriptions were prescribed off-label</p><p>according to the SmPC. 17.93% of total prescriptions in neonates and infants up to</p><p>1 year old were not based on clinical evidence from SmPC, Pediamécum, BNF or</p><p>DailyMed. In more than 88% of cases, off-label use was related to the posology</p><p>section of the SmPC, followed by the therapeutic indications and contraindications</p><p>sections, in 35.20% and 24.10% of cases, respectively. Almost 13% of off-label drugs</p><p>were over-the-counter. Salbutamol followed by topical tobramycin and colecalciferol</p><p>were the drugs most prescribed off-label.</p><p>Conclusions: Off-label use of drugs remains as an important public health concern, especially</p><p>for neonates and infants up to 1 year, who receive the greatest proportion of offlabel</p><p>prescriptions. The evidence-based off-label prescription is a widespread practice</p><p>that has shown a stable trend during the 5-year study period providing also a certain</p><p>extent of flexibility to paediatricians in some therapeutic decisions.