Journal
BMC PEDIATRICS
Volume 16, Issue -, Pages -Publisher
BMC
DOI: 10.1186/s12887-016-0551-8
Keywords
Off-label use; Unlicensed medicines; Harmful excipients; High-alert medications; Neonate; Drug
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Funding
- Institute of Health Science Research and Teaching Foundation (FEPECS)
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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 < 31 weeks (p < 0.05). Anti-infectives for systemic use, blood, alimentary tract and metabolism drug groups were more frequent, varying according to the GA. Neonates (99.5 %) were exposed to unlicensed drugs (UL) and off label use (OL), more frequently in GA < 28 weeks (p < 0.05). Most OL drugs used were indicated for newborns. 15 potentially harmful drugs were used in more than 70 % of the neonates, and most were OL; exposure to harmful excipients occurred in 91.6 % of the neonates, a percentage even higher when considering immature neonates. Conclusions: Immature neonates in a Brazilian NICU are exposed to a variety of OL, UL and potentially harmful drugs and excipients.
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