Banca de DEFESA: HALINE TEREZA MATIAS DE LIMA COSTA

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
DISCENTE : HALINE TEREZA MATIAS DE LIMA COSTA
DATA : 03/07/2017
HORA: 09:00
LOCAL: SALA DE AULA II DO PPGCF
TÍTULO:

UTILIZATION  OF  OFF-LABEL  AND  UNLICENSED  MEDICINES  IN  NEONATAL  INTENSIVE  CARE  UNIT.

PALAVRAS-CHAVES:

Drug utilization. Drug-drug interaction. Intensive care unit. Off-label use. Neonate.

PÁGINAS: 128
GRANDE ÁREA: Ciências da Saúde
ÁREA: Farmácia
RESUMO:

INTRODUCTION: Several studies have shown that a significant number of drugs prescribed to pediatric patients are off-label or unlicensed, but there is little information about the use of these drugs in neonatal intensive care units (NICUs), as well as studies about risk factors for drug-drug interactions (DDI). PURPOSE: To evaluate the use of off-label and unlicensed drugs in a Brazilian NICU of a teaching maternity hospital specialized in high risk pregnancy, and the frequency of DDI and associated risk factors. METHODS: A descriptive, observational, prospective cohort study was conducted between august 2015 and august 2016. All newborns admitted consecutively in the NICU of the Maternity School Januário Cicco for over 24 hours and who had at least one medication prescribed were included. Demographic and clinical data were collected, as well as all medications prescribed during hospitalization. The classification of off-label and unlicensed drugs for the neonatal population according to the Food and Drug Administration criteria was done based on the DrugDex-Micromedex® database, which was also used for the classification of DDI. Logistic regression was used for the analysis of risk factors. RESULTS: A total of 17421 prescriptions items were analyzed in 3935 prescriptions of 220 newborns, of whom 96.4% were exposed to off-label medications and 66.8% to unlicensed drugs. More than 70% of premature and neonates with birth weight less than 2000g were submitted to off-label medicines and more than 50% to unlicensed. The anti-infectives for systemic use were the most prescribed off-label pharmacological group and the drugs most frequently classified as off-label for newborn were Fentanil (n= 1358) and gentamicin (n= 1197). Caffeine (n = 1226) was the most prescribed unlicensed drug, followed by cardiovascular agents (n= 648) modified by nursing. DDIs were found in 42,3% (n= 1665) of prescriptions , with number of drugs (OR 1.60, p<0,001), cesarean delivery (OR 2.68, p = 0,06) and gestational age (OR 1.03, p = 0,002) as risk factors for major DDI. CONCLUSION: Neonates in intensive care units have a high rate of prescriptions and exposure to off-label and unlicensed drugs, with antimicrobials for systemic use and drugs action on nervous system as the most frequently prescribed, as well as a high incidence of DDI, with number of medicines, cesarean delivery and gestational age being risk factors for major DDI.

MEMBROS DA BANCA:
Presidente - 1048067 - ANTONIO MANUEL GOUVEIA DE OLIVEIRA
Externo à Instituição - DJANILSON BARBOSA DOS SANTOS - UFRB
Externo ao Programa - 2149416 - MARIA DA CONCEICAO DE MESQUITA CORNETTA