1. Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study
- Author
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Marina dos Santos Garruti de Medeiros, Alcidésio Sales de Souza, Luís C. Rey, Helena Lutescia Luna Coelho, Marta Gonçalves Vieira, and Djanilson Barbosa dos Santos
- Subjects
Male ,Drug ,Drug Utilization ,medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,health care facilities, manpower, and services ,media_common.quotation_subject ,education ,Off-label use ,Risk Assessment ,03 medical and health sciences ,Neonate ,0302 clinical medicine ,Intensive Care Units, Neonatal ,030225 pediatrics ,Intensive care ,Humans ,Medicine ,Pediatrics, Perinatology, and Child Health ,030212 general & internal medicine ,Practice Patterns, Physicians' ,Intensive care medicine ,Retrospective Studies ,media_common ,Unlicensed medicines ,Practice patterns ,business.industry ,Infant, Newborn ,Retrospective cohort study ,Off-Label Use ,Harmful excipients ,High-alert medications ,Pediatrics, Perinatology and Child Health ,Intensive care neonatal ,Intensive Care, Neonatal ,Female ,Risk assessment ,business ,Brazil ,Infant, Premature ,Research Article - Abstract
Background Neonates admitted to neonatal intensive care units (NICU) are exposed to a wide variety of drugs, most without any data on safety and efficacy. Objective: To describe the drugs prescribed to different groups of neonates hospitalized in a NICU, and to analyze off-label use and harmful potential of drugs, in terms of the potential risks. Methods This was a six-month retrospective cohort study of drug use in a NICU, with neonates who were inpatients for a period of over 24 hours, and using prescription data from electronic medical records. Drug information found in the package leaflets, in the British National Formulary for Children 2012–2013, and in the Thomson Micromedex database were compared. Drugs and excipients considered potentially harmful were evaluated according to the literature. Results One hundred ninety-two neonates were included in the study, with a mean gestational age (GA) of 33.3 weeks (SD ± 4.3), 75.0 % were preterm, with an average of 18.8 days of hospitalization (SD ± 18.1), and a total of 3617 neonates-day. 3290 prescriptions were registered, on average 17.1 prescriptions/neonate (SD ± 17.9) and 8.8 drugs/neonate (SD ± 5.9). The number of prescriptions and drugs was higher in neonates with GA
- Published
- 2016
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