Pediatric drugs: management in Primary Care

E Blanco1, MA Vega2, I Bellido1, J De Pablo2, EI Márquez1. 1University of Málaga, Pharmacology, School of Medicine, Spain, 2Primary Care District of Málaga, La Victoria Health Centre, Spain

New regulatory initiatives have been designed to ensure that new drugs and biologicals include adequate pediatric labeling for the claimed indications at the time of, or soon after, approval (Regulation EC No 1901/2006 of the European Parliament 2006 on medicinal products for paediatric use). However, because such labeling may not immediately be available, off-label use of therapeutic agents is likely to remain common in the practice of pediatrics. Hospitalised children receive up to 90 % of their drug prescriptions without ("unlicensed use") or outside ("off-label use") the terms of their product license.

Objective: As there are very few studies conducted for pediatric outpatients, we decided to determine the frequency of these practices and to describe the drugs prescription pattern used among these children.

Methods: A cross-sectional study including 283 children. Setting: pediatric visits of two urban primary care centres. To avoid bias data were collected in two different seasons, winter and summer. Sociodemographics, clinics and information about drugs prescriptions were recorded. The SPC (Summary of Product Characteristics) was used as the primary reference source. The licence status of each drug was determined according to the SPC.

Results: We analysed 292 prescriptions of 61 different drugs that correspond to
78 medicinal products, plus 5 dietary products. The average age was 4.6 (±3.0) years (range: 22 days to 13 years). The most frequent reasons for consultation were respiratory causes (mainly in winter), followed by dermatologic (mainly in summer) and otitis. Average drugs/patient was 1.5 (±1,1), and the level of exposure to drugs was lower in summer. The most commonly prescribed classes of drug were (% of children): R group (62%), M group (32%), J group (15%), D (15%) and N group (12%). The most frequently used agent was ibuprofen, followed by acetaminophen, budesonide and amoxicillin-clavulanic. Only two children received at least one UL prescription (diclofenac eye drops and ciprofloxacin in a child under 7 years). 33% of children (27% prescriptions) received at least one OL prescription (no significant differences between the two centres). Reasons for off label use were: age (57%; e.g. fluticasone+salmeterol in children under 4 years, or budesonide in children under 2 years), doses (30%; e.g. underdosing by weight of azitromicine and ibuprofen), indication (8%; e.g budesonide and salbutamol for bronchiolitis) and route (5%). On the other hand 30% of drugs were not available the SPC (about one fourth of the prescriptions), wich corresponds to the oldest drugs (e.g. prednisolone drops, carbocisteine-promethazine, cloperastine syrup, clotrimazol pomade, and other).

Conclusions: "Off-label" prescribing in outpatient children is less frequent than in pediatric inpatients. However, it can have a significant impact given the far greater number of children treated at this level. Efforts to improve pediatric labeling are important. However, off-label use is often medically appropriate and in some cases may even represent the standard of care in the treament of a given condition. It is important to analyze the evidence-based practices in Pediatrics.