Background: Many drugs are prescribed outside the terms of the marketing authorization ("off-label"). Several studies have shown that this is a common practice in various European healthcare settings.
Objective: This study aimed to quantify and characterize off-label drug prescribing in children admitted to a Portuguese Paediatric Unit (PEU).
Setting: This study was conducted in the Paediatric Unit of the university teaching hospital of Cova da Beira Hospital Centre (CHCB), Covilhã, located in the Eastern Central Region of Portugal.
Method: A descriptive study was conducted, including a sample of 700 children, randomly selected from those admitted between January to October 2010. Drug prescription was assessed by retrospective review of clinical files.
Main Outcome Measure: Off-label prescribing was defined as the utilization of a drug at an indication, age, dosage, frequency or route of administration different from those recommended in the Summary of Product Characteristics (SPC). For purposes of this study only the medicines prescribed to be used after discharge from the hospital were studied.
Results: 364 boys and 336 girls, aged from 4 days to 18 years, were included in this study. Of the 724 medicines prescribed, 32.2 % were off-label. At least one drug was used off-label in 28.1 % of the studied population, corresponding to 46.1 % of the 427 children that received prescriptions. "Alteration in dosage" was the commonest reason for off-label prescribing (28.2 %). The off-label prescriptions comprised mainly drugs acting on the "Respiratory System" and "Anti-infectious agents for systemic use". Amoxicillin/clavulanic acid, paracetamol, amoxicillin, ibuprofen and salbutamol were the five active principles most frequently prescribed off-label.
Conclusion: The prevalence of off-label drug prescribing in the Portuguese PEU of CHCB is high, the use in a dose or for an age group not approved in the SPC being the most common reasons for off-label prescription.
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