E Blanco-Reina1, A F Medina-Claros2, M A Vega-Jiménez3, R Ocaña-Riola4, E I Márquez-Romero5, Á Ruiz-Extremera6. 1. Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España. Electronic address: eblanco@uma.es. 2. UGC de Pediatría, Hospital Axarquía, Vélez-Málaga, Málaga, España. 3. Medicina de Familia, Centro de Salud La Victoria, Distrito Sanitario de Málaga, Málaga, España. 4. Departamento de Matemáticas, Escuela Andaluza de Salud Pública, Granada, España. 5. Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España; Dispositivo de Cuidados Críticos y Urgencias, Distrito Sanitario Málaga, Málaga, España. 6. Departamento de Pediatría, Universidad de Granada, Granada, España; Unidad de Apoyo a la Investigación, Hospital Universitario San Cecilio, CIBERehd, Granada, España.
Abstract
OBJECTIVE: This study aims to assess the prescription profile and license status of drugs used in a neonatal and pediatric intensive care unit (NPICU). METHODS: A prospective observational study was conducted on a dynamic cohort of children admitted to an NPICU (N=81) in a tertiary hospital (Granada, Spain). All prescriptions were classified as off-label or unlicensed based on the summary of product characteristics (SPC). RESULTS: Of a total of 601 prescriptions, the patients received a mean of 7.4 ± 6 drugs each. The most commonly prescribed drugs corresponded to classes J (anti-infectious, systemic use) N (nervous system) and C (cardiovascular). A little over one-half of the prescriptions were off-label (52%), usually due to dosages differing from the SPC recommendations (79%), followed by different indications (13.5%), age (5%) and administration route (2.5%). In this NPICU, unlicensed usage represented only 5% of all prescriptions. CONCLUSIONS: This study contributes data on prescription of this kind in a Spanish NPICU, revealing at least one off-label prescription in 89% of the children and at least one unlicensed use in 22.3%. These are high figures, but are to be expected given the inclusion of newborn infants and the critical care setting. Even though such usage follows clinical protocols, we underscore the dual need to base treatment on the best available evidence, and to upgrade the SPC accordingly.
OBJECTIVE: This study aims to assess the prescription profile and license status of drugs used in a neonatal and pediatric intensive care unit (NPICU). METHODS: A prospective observational study was conducted on a dynamic cohort of children admitted to an NPICU (N=81) in a tertiary hospital (Granada, Spain). All prescriptions were classified as off-label or unlicensed based on the summary of product characteristics (SPC). RESULTS: Of a total of 601 prescriptions, the patients received a mean of 7.4 ± 6 drugs each. The most commonly prescribed drugs corresponded to classes J (anti-infectious, systemic use) N (nervous system) and C (cardiovascular). A little over one-half of the prescriptions were off-label (52%), usually due to dosages differing from the SPC recommendations (79%), followed by different indications (13.5%), age (5%) and administration route (2.5%). In this NPICU, unlicensed usage represented only 5% of all prescriptions. CONCLUSIONS: This study contributes data on prescription of this kind in a Spanish NPICU, revealing at least one off-label prescription in 89% of the children and at least one unlicensed use in 22.3%. These are high figures, but are to be expected given the inclusion of newborn infants and the critical care setting. Even though such usage follows clinical protocols, we underscore the dual need to base treatment on the best available evidence, and to upgrade the SPC accordingly.
Authors: Lucas Louro Greenhalgh; Márcia Maria Barros Dos Passos; Arthur Lopes Agrizzi; Mariana Sato de Souza Bustamante Monteiro Journal: Rev Paul Pediatr Date: 2022-09-09
Authors: H Christine Allen; M Connor Garbe; Julie Lees; Naila Aziz; Hala Chaaban; Jamie L Miller; Peter Johnson; Stephanie DeLeon Journal: J Okla State Med Assoc Date: 2018-10