OBJECTIVE: To describe the use of medicines and to determine the frequency of off-label use in emergency room paediatric patients. PATIENTS AND METHODS: A prospective, observational and descriptive study was carried out in the setting of the paediatric emergency room of a Spanish general hospital. Medicines used by children <14 years prior to their emergency room visit were analysed based on information collected from parents/guardians and relatives for each drug prescription. Off-label use was defined as the utilization of a drug at an indication, dosage, frequency or route of administration that differed from the specifications in the Summary of Product Characteristics or by children outside the authorized age group. RESULTS: The patient cohort comprised 462 children, among whom 336 children had been prescribed 667 prescriptions. Of the medicines prescribed, 90% fell into only five 5 Anatomical Therapeutic Chemical Classification System groups. The most frequent active principles were ibuprofen and paracetamol. Of a total of 152 different formulations recorded, no paediatric information was provided for 40 formulations, and one formulation was contraindicated in children. Based on the established criteria, 338 prescriptions were off-label: no paediatric information or contraindication in children were available (82 prescriptions); the drug was used for an indication different from the authorized one (111 prescriptions); drug use was inconsistent with age recommendations (16 prescriptions); drug use was inconsistent with dose/frequency (129 prescriptions). Of the 152 formulations, 107 were occasionally used in an off-label manner. CONCLUSIONS: Although the mean number of drugs used in children is small, off-label use is frequent. Research efforts should target paediatric studies that allow a rational drug use in children.
OBJECTIVE: To describe the use of medicines and to determine the frequency of off-label use in emergency room paediatric patients. PATIENTS AND METHODS: A prospective, observational and descriptive study was carried out in the setting of the paediatric emergency room of a Spanish general hospital. Medicines used by children <14 years prior to their emergency room visit were analysed based on information collected from parents/guardians and relatives for each drug prescription. Off-label use was defined as the utilization of a drug at an indication, dosage, frequency or route of administration that differed from the specifications in the Summary of Product Characteristics or by children outside the authorized age group. RESULTS: The patient cohort comprised 462 children, among whom 336 children had been prescribed 667 prescriptions. Of the medicines prescribed, 90% fell into only five 5 Anatomical Therapeutic Chemical Classification System groups. The most frequent active principles were ibuprofen and paracetamol. Of a total of 152 different formulations recorded, no paediatric information was provided for 40 formulations, and one formulation was contraindicated in children. Based on the established criteria, 338 prescriptions were off-label: no paediatric information or contraindication in children were available (82 prescriptions); the drug was used for an indication different from the authorized one (111 prescriptions); drug use was inconsistent with age recommendations (16 prescriptions); drug use was inconsistent with dose/frequency (129 prescriptions). Of the 152 formulations, 107 were occasionally used in an off-label manner. CONCLUSIONS: Although the mean number of drugs used in children is small, off-label use is frequent. Research efforts should target paediatric studies that allow a rational drug use in children.
Authors: Antje Neubert; Ian C K Wong; Alessandro Bonifazi; Mariana Catapano; Mariagrazia Felisi; Paola Baiardi; Carlo Giaquinto; Catherijne A J Knibbe; Miriam C J M Sturkenboom; Maisoon A Ghaleb; Adriana Ceci Journal: Pharmacol Res Date: 2008-09-18 Impact factor: 7.658
Authors: C Morales-Carpi; L Estañ Yago; I Torró Doménech; E Lurbe Ferrer; F J Morales-Olivas Journal: An Pediatr (Barc) Date: 2006-02 Impact factor: 1.500
Authors: Rob McCarney; James Warner; Steve Iliffe; Robbert van Haselen; Mark Griffin; Peter Fisher Journal: BMC Med Res Methodol Date: 2007-07-03 Impact factor: 4.615