USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT
ABSTRACT Objective: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. Methods: A cross-sectional study was carried out, using a convenience sample o...
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| Format: | Article |
| Language: | English |
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Sociedade de Pediatria de São Paulo
2021-01-01
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| Series: | Revista Paulista de Pediatria |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0103-05822021000100454&tlng=en |
| _version_ | 1818568008734343168 |
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| author | Erica Inez Alves Koszma Ana Jovina Barreto Bispo Isabelle Araujo de Oliveira Santana Catharine Natielle Oliveira Dias Belarmino dos Santos |
| author_facet | Erica Inez Alves Koszma Ana Jovina Barreto Bispo Isabelle Araujo de Oliveira Santana Catharine Natielle Oliveira Dias Belarmino dos Santos |
| author_sort | Erica Inez Alves Koszma |
| collection | DOAJ |
| description | ABSTRACT Objective: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. Methods: A cross-sectional study was carried out, using a convenience sample of newborns that used mechanical ventilation at the Intensive Care Unit. As a reference, OL medications were considered for those without an approval for newborn usage by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) and by the Food and Drugs Administration (FDA). Results: The sample consisted of 158 newborns, 58.3% male, 87.7% premature, and 70.2% of low or very low birth weight. According to ANVISA, 440 out of the 1,167 prescriptions analyzed were OL, with 98.1% of newborns exposed to at least one of these drugs. According to the FDA, 484 prescriptions were OL, with 75.8% of newborns exposed to at least one of them. Anti-infectives were the most prescribed OL medications. Neonates who presented respiratory failure and pneumonia used these drugs more often; and there was no relation between their use and the number of deaths. Conclusions: Nearly all newborns at the Intensive Care Units, mainly preterm infants, are exposed to at least one off-label (OL) medication during hospital stay, according to the national and international regulatory agencies. No association was found between off-label prescriptions and the frequency of complications or neonatal deaths. |
| first_indexed | 2024-12-14T06:30:38Z |
| format | Article |
| id | doaj.art-9006dede57dd4fe29ef01dcdcabad68c |
| institution | Directory Open Access Journal |
| issn | 1984-0462 |
| language | English |
| last_indexed | 2024-12-14T06:30:38Z |
| publishDate | 2021-01-01 |
| publisher | Sociedade de Pediatria de São Paulo |
| record_format | Article |
| series | Revista Paulista de Pediatria |
| spelling | doaj.art-9006dede57dd4fe29ef01dcdcabad68c2022-12-21T23:13:32ZengSociedade de Pediatria de São PauloRevista Paulista de Pediatria1984-04622021-01-013910.1590/1984-0462/2021/39/2020063USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNITErica Inez Alves Koszmahttps://orcid.org/0000-0001-6464-9851Ana Jovina Barreto Bispohttps://orcid.org/0000-0002-6228-768XIsabelle Araujo de Oliveira Santanahttps://orcid.org/0000-0001-8493-9864Catharine Natielle Oliveira Dias Belarmino dos Santoshttps://orcid.org/0000-0002-7125-9349ABSTRACT Objective: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. Methods: A cross-sectional study was carried out, using a convenience sample of newborns that used mechanical ventilation at the Intensive Care Unit. As a reference, OL medications were considered for those without an approval for newborn usage by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) and by the Food and Drugs Administration (FDA). Results: The sample consisted of 158 newborns, 58.3% male, 87.7% premature, and 70.2% of low or very low birth weight. According to ANVISA, 440 out of the 1,167 prescriptions analyzed were OL, with 98.1% of newborns exposed to at least one of these drugs. According to the FDA, 484 prescriptions were OL, with 75.8% of newborns exposed to at least one of them. Anti-infectives were the most prescribed OL medications. Neonates who presented respiratory failure and pneumonia used these drugs more often; and there was no relation between their use and the number of deaths. Conclusions: Nearly all newborns at the Intensive Care Units, mainly preterm infants, are exposed to at least one off-label (OL) medication during hospital stay, according to the national and international regulatory agencies. No association was found between off-label prescriptions and the frequency of complications or neonatal deaths.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0103-05822021000100454&tlng=enInfant, newbornDrug utilizationOff-label useIntensive Care Units, Neonatal |
| spellingShingle | Erica Inez Alves Koszma Ana Jovina Barreto Bispo Isabelle Araujo de Oliveira Santana Catharine Natielle Oliveira Dias Belarmino dos Santos USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT Revista Paulista de Pediatria Infant, newborn Drug utilization Off-label use Intensive Care Units, Neonatal |
| title | USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT |
| title_full | USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT |
| title_fullStr | USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT |
| title_full_unstemmed | USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT |
| title_short | USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT |
| title_sort | use of off label medications in a neonatal intensive care unit |
| topic | Infant, newborn Drug utilization Off-label use Intensive Care Units, Neonatal |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0103-05822021000100454&tlng=en |
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