TY - JOUR T1 - Comparative assessment of off-label and unlicensed drug prescription in neonatal intensive care: FDA versus Brazilian guidelines JO - Anales de Pediatría (English Edition) T2 - AU - Lima Costa,Haline Tereza Matias AU - Peres Florencio,Arlan AU - do Vale Bezerra,Priscilla Karilline AU - Chaves Cavalcanti,Jéssica Escorel AU - Xavier Costa,Tatiana AU - Medeiros Fernandes,Flavia Evelyn AU - Rand Randall,Martins SN - 23412879 M3 - 10.1016/j.anpede.2020.07.007 DO - 10.1016/j.anpede.2020.07.007 UR - https://www.analesdepediatria.org/en-comparative-assessment-off-label-unlicensed-drug-articulo-S2341287920302581 AB - IntroductionRegulatory agencies are responsible for defining the use of off-label (OL) and unlicensed (UL) drug prescription in neonatal intensive care. However, these regulatory criteria may differ between agencies in different countries. The aim of this study was to establish the frequency of OL and UL drug prescription in a sample of patients in a neonatal intensive care unit applying the criteria of the Food and Drug Administration (FDA) of the United States and the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil, analysing the differences observed in the results based on the applied criteria. MethodsProspective cohort study in neonates admitted for more than 24h to the NICU of a teaching maternity hospital between August 2017 and July 2018. We obtained information concerning the drugs included in the analysis of OL and UL prescriptions from the DrugDex-Micromedex® and official information on pharmaceutical products in Brazil. We used the kappa correlation coefficient to assess the agreement between the FDA and ANVISA criteria. We defined disagreement as a kappa value of less than 0.200. ResultsWe evaluated 220 neonates admitted to the NICU and 17,421 items prescribed during the study period. We did not find a difference in the proportion of neonates in which at least 1 drug was prescribed under OL conditions applying the FDA versus the ANVISA criteria (96.4% vs. 98.6%). We found differences between the FDA and ANVISA in the OL classification based on the authorized age of use and indications for prescription, mainly in systemic antimicrobials and cardiovascular drugs. When we compared the prescribing information provided by the FDA and the ANVISA, we found that the criteria of the ANVISA were less specific. ConclusionOff-label and unlicensed drug prescription are frequent in neonatal intensive care applying the criteria of either agency, although the FDA has established more detailed criteria in terms of the ages and indications for which prescription is authorized. ER -