Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Tipo de documento: | Trabalho de conclusão de curso |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRN |
Texto Completo: | https://repositorio.ufrn.br/handle/123456789/35818 |
Resumo: | Introduction: Regulatory agencies are responsible for order the use of off-label (OL) and unlicensed drugs (UL) prescriptions in neonatal intensive care (NICU). However, these criteria may differ between 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 American Food and Drug Administration (FDA) and Brazilian National Health Surveillance Agency (Anvisa) and analyzing the divergences between the results. Methods: Prospective cohort study developed between August 2017 and July 2018 with neonates admitted for more than 24 hours in a teaching maternity hospital. The drugs were investigated for prescription OL and UL through DrugDexMicromedex® and the official Brazilian drug information. The kappa correlation coefficient was used to assess the agreement between the FDA and Anvisa criteria. Kappa values <0.200 were considered non-concordant. Results: During the study period, 220 neonates and 17421 prescribed items were evaluated. The proportion of neonates with at least one medication prescribed as OL does not differ between the agencies FDA and Anvisa (96.4% vs 98.6%). The FDA and Anvisa differ as to the OL classification in the ages approved for use and indications, mainly in antimicrobials for systemic use and cardiovascular drugs. When comparing drug information between the FDA and Anvisa, we highlight that the Brazilian agency is less accurate. Conclusion: The use of OL and UL drugs in neonatal intensive care is high when assessed by both regulatory agencies; however, the FDA is more accurate in describing the ages and indications approved for use. |
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Florencio, Arlan PeresMartins, Rand RandallAraújo, Sérgio Ricardo Fernandes deDiniz, Rodrigo dos SantosMartins, Rand Randall2020-07-09T14:23:25Z2021-09-20T17:52:23Z2020-07-09T14:23:25Z20202016081845FLORENCIO, Arlan Peres. Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines. 2020. 26f. Trabalho de Conclusão de Curso (Graduação em Farmácia) - Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Natal, 2020.https://repositorio.ufrn.br/handle/123456789/35818Introduction: Regulatory agencies are responsible for order the use of off-label (OL) and unlicensed drugs (UL) prescriptions in neonatal intensive care (NICU). However, these criteria may differ between 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 American Food and Drug Administration (FDA) and Brazilian National Health Surveillance Agency (Anvisa) and analyzing the divergences between the results. Methods: Prospective cohort study developed between August 2017 and July 2018 with neonates admitted for more than 24 hours in a teaching maternity hospital. The drugs were investigated for prescription OL and UL through DrugDexMicromedex® and the official Brazilian drug information. The kappa correlation coefficient was used to assess the agreement between the FDA and Anvisa criteria. Kappa values <0.200 were considered non-concordant. Results: During the study period, 220 neonates and 17421 prescribed items were evaluated. The proportion of neonates with at least one medication prescribed as OL does not differ between the agencies FDA and Anvisa (96.4% vs 98.6%). The FDA and Anvisa differ as to the OL classification in the ages approved for use and indications, mainly in antimicrobials for systemic use and cardiovascular drugs. When comparing drug information between the FDA and Anvisa, we highlight that the Brazilian agency is less accurate. Conclusion: The use of OL and UL drugs in neonatal intensive care is high when assessed by both regulatory agencies; however, the FDA is more accurate in describing the ages and indications approved for use.Introduction: Regulatory agencies are responsible for order the use of off-label (OL) and unlicensed drugs (UL) prescriptions in neonatal intensive care (NICU). However, these criteria may differ between 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 American Food and Drug Administration (FDA) and Brazilian National Health Surveillance Agency (Anvisa) and analyzing the divergences between the results. Methods: Prospective cohort study developed between August 2017 and July 2018 with neonates admitted for more than 24 hours in a teaching maternity hospital. The drugs were investigated for prescription OL and UL through DrugDexMicromedex® and the official Brazilian drug information. The kappa correlation coefficient was used to assess the agreement between the FDA and Anvisa criteria. Kappa values <0.200 were considered non-concordant. Results: During the study period, 220 neonates and 17421 prescribed items were evaluated. The proportion of neonates with at least one medication prescribed as OL does not differ between the agencies FDA and Anvisa (96.4% vs 98.6%). The FDA and Anvisa differ as to the OL classification in the ages approved for use and indications, mainly in antimicrobials for systemic use and cardiovascular drugs. When comparing drug information between the FDA and Anvisa, we highlight that the Brazilian agency is less accurate. Conclusion: The use of OL and UL drugs in neonatal intensive care is high when assessed by both regulatory agencies; however, the FDA is more accurate in describing the ages and indications approved for use.2023-07-08Universidade Federal do Rio Grande do NorteUFRNBrasilFarmáciaoff labeloff labelindicações não aprovadasUnapproved indicationsnão licenciadasUnlicensedunidade de terapia intensiva neonatalNeonatal intensive care unitComparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelinesinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/bachelorThesisengreponame:Repositório Institucional da UFRNinstname:Universidade Federal do Rio Grande do Norte (UFRN)instacron:UFRNinfo:eu-repo/semantics/openAccessLICENSElicense.txttext/plain714https://repositorio.ufrn.br/bitstream/123456789/35818/1/license.txt7278bab9c5c886812fa7d225dc807888MD51ORIGINALComparativeassessmentofoff-label_Florencio_2020Texto Completoapplication/octet-stream648573https://repositorio.ufrn.br/bitstream/123456789/35818/2/Comparativeassessmentofoff-label_Florencio_202018a15f332cdb6b86d509c02b0b983674MD52TEXTComparativeassessmentofoff-label_Florencio_2020.txtExtracted texttext/plain55826https://repositorio.ufrn.br/bitstream/123456789/35818/3/Comparativeassessmentofoff-label_Florencio_2020.txt44901231d41a1218977446f86751aadeMD53123456789/358182024-03-19 01:03:00.552oai:https://repositorio.ufrn.br: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ório de PublicaçõesPUBhttp://repositorio.ufrn.br/oai/opendoar:2024-03-19T04:03Repositório Institucional da UFRN - Universidade Federal do Rio Grande do Norte (UFRN)false |
dc.title.pt_BR.fl_str_mv |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines |
title |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines |
spellingShingle |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines Florencio, Arlan Peres off label off label indicações não aprovadas Unapproved indications não licenciadas Unlicensed unidade de terapia intensiva neonatal Neonatal intensive care unit |
title_short |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines |
title_full |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines |
title_fullStr |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines |
title_full_unstemmed |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines |
title_sort |
Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines |
author |
Florencio, Arlan Peres |
author_facet |
Florencio, Arlan Peres |
author_role |
author |
dc.contributor.referees1.none.fl_str_mv |
Martins, Rand Randall |
dc.contributor.referees2.none.fl_str_mv |
Araújo, Sérgio Ricardo Fernandes de |
dc.contributor.referees3.none.fl_str_mv |
Diniz, Rodrigo dos Santos |
dc.contributor.author.fl_str_mv |
Florencio, Arlan Peres |
dc.contributor.advisor1.fl_str_mv |
Martins, Rand Randall |
contributor_str_mv |
Martins, Rand Randall |
dc.subject.por.fl_str_mv |
off label off label indicações não aprovadas Unapproved indications não licenciadas Unlicensed unidade de terapia intensiva neonatal Neonatal intensive care unit |
topic |
off label off label indicações não aprovadas Unapproved indications não licenciadas Unlicensed unidade de terapia intensiva neonatal Neonatal intensive care unit |
description |
Introduction: Regulatory agencies are responsible for order the use of off-label (OL) and unlicensed drugs (UL) prescriptions in neonatal intensive care (NICU). However, these criteria may differ between 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 American Food and Drug Administration (FDA) and Brazilian National Health Surveillance Agency (Anvisa) and analyzing the divergences between the results. Methods: Prospective cohort study developed between August 2017 and July 2018 with neonates admitted for more than 24 hours in a teaching maternity hospital. The drugs were investigated for prescription OL and UL through DrugDexMicromedex® and the official Brazilian drug information. The kappa correlation coefficient was used to assess the agreement between the FDA and Anvisa criteria. Kappa values <0.200 were considered non-concordant. Results: During the study period, 220 neonates and 17421 prescribed items were evaluated. The proportion of neonates with at least one medication prescribed as OL does not differ between the agencies FDA and Anvisa (96.4% vs 98.6%). The FDA and Anvisa differ as to the OL classification in the ages approved for use and indications, mainly in antimicrobials for systemic use and cardiovascular drugs. When comparing drug information between the FDA and Anvisa, we highlight that the Brazilian agency is less accurate. Conclusion: The use of OL and UL drugs in neonatal intensive care is high when assessed by both regulatory agencies; however, the FDA is more accurate in describing the ages and indications approved for use. |
publishDate |
2020 |
dc.date.accessioned.fl_str_mv |
2020-07-09T14:23:25Z 2021-09-20T17:52:23Z |
dc.date.available.fl_str_mv |
2020-07-09T14:23:25Z |
dc.date.issued.fl_str_mv |
2020 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/bachelorThesis |
format |
bachelorThesis |
status_str |
publishedVersion |
dc.identifier.pt_BR.fl_str_mv |
2016081845 |
dc.identifier.citation.fl_str_mv |
FLORENCIO, Arlan Peres. Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines. 2020. 26f. Trabalho de Conclusão de Curso (Graduação em Farmácia) - Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Natal, 2020. |
dc.identifier.uri.fl_str_mv |
https://repositorio.ufrn.br/handle/123456789/35818 |
identifier_str_mv |
2016081845 FLORENCIO, Arlan Peres. Comparative assessment of off-label and unlicensed drug prescription in neonates: FDA vs brazilian guidelines. 2020. 26f. Trabalho de Conclusão de Curso (Graduação em Farmácia) - Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Natal, 2020. |
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https://repositorio.ufrn.br/handle/123456789/35818 |
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eng |
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eng |
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openAccess |
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Universidade Federal do Rio Grande do Norte |
dc.publisher.initials.fl_str_mv |
UFRN |
dc.publisher.country.fl_str_mv |
Brasil |
dc.publisher.department.fl_str_mv |
Farmácia |
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Universidade Federal do Rio Grande do Norte |
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