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- W3040895939 abstract "Introduction: Regulatory agencies are responsible for order the use of off-label (OL) and unlicenseddrugs (UL) prescriptions in neonatal intensive care (NICU). However, these criteria may differbetween agencies in different countries. The aim of this study were defining the incidence of off-label(OL) and unlicensed drugs (UL) prescriptions in a sample of NICU patients according to AmericanFood and Drug Administration (FDA) and Brazilian National Health Surveillance Agency (Anvisa)and analyzing the divergences between the results. Methods: Prospective cohort study developedbetween August 2017 and July 2018 with neonates admitted for more than 24 hours in a teachingmaternity hospital. The drugs were investigated for prescription OL and UL through DrugDexMicromedex® and the official Brazilian drug information. The kappa correlation coefficient was usedto assess the agreement between the FDA and Anvisa criteria. Kappa values <0.200 were considerednon-concordant. Results: During the study period, 220 neonates and 17421 prescribed items wereevaluated. The proportion of neonates with at least one medication prescribed as OL does not differbetween the agencies FDA and Anvisa (96.4% vs 98.6%). The FDA and Anvisa differ as to the OLclassification in the ages approved for use and indications, mainly in antimicrobials for systemic useand cardiovascular drugs. When comparing drug information between the FDA and Anvisa, wehighlight that the Brazilian agency is less accurate. Conclusion: The use of OL and UL drugs inneonatal intensive care is high when assessed by both regulatory agencies; however, the FDA is moreaccurate in describing the ages and indications approved for use." @default.
- W3040895939 created "2020-07-16" @default.
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- W3040895939 date "2020-01-01" @default.
- W3040895939 modified "2023-09-28" @default.
- W3040895939 title "Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines" @default.
- W3040895939 hasPublicationYear "2020" @default.
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