Unapproved prescription practices in primary pediatric clinics in Israel: A prospective analysis

Background: Many medications have not been approved for children because of a lack of data that can ensure acceptable standards of safety, efficacy, and optimal dose. Objective: The purpose of this study was to determine the extent of unlicensed and off-label medications used in primary pediatric clinics in Israel. Methods: This study was a prospective analysis of medications prescribed during consecutive clinic visits to children from different ethnic communities and different regions of Israel, during different seasons of the year. Pediatricians completed forms with patient and medication data for each patient visit included in the study. The product licenses for age, dose, indication, and route of administration of medications prescribed to children aged <18 years were compared. Results: The study was carried out in the clinical practices of 6 board-certified pediatricians treating a total of ∼9300 children in 2000-2001. A total of 1925 prescriptions for 160 different medications were given to 1802 children (959 boys, 843 girls, mean [SD] age, 4.8 [3.9] years). Of the 298 (15.5%) of unapproved prescriptions given, 1 (0.3%) was for an unlicensed medication, and 297 (99.7%) were given in an off-label manner to 280 children (15.5%). Antibiotic and antiasthmatic agents were the most frequently prescribed off-label medications. Infants received more unapproved medications than did children (P < 0.001), and children, more than did adolescents (P < 0.001). Statistical analysis did not reveal significant ethnic or seasonal differences in off-label prescribing practices. Conclusions: Based on the results of the present survey, many medications prescribed to children have not passed the licensing process as exists for adults. A large number of children in primary pediatric clinics in Israel as well as in other countries receive a myriad of unapproved medication prescriptions.