Use of Off-Label Medications in a Neonatal Intensive Care Unit

Koszma, Erica Inez Alves; Bispo, Ana Jovina Barreto; Santana, Isabelle Araujo de Oliveira; Santos, C

doi:10.1590/1984-0462/2021/39/2020063

Cited by 3 publications

(2 citation statements)

References 15 publications

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“…In Brazil, newborns admitted to the neonatal care unit (NCU) also receive compound preparations [ 26 ]. According to Koszma et al, 98.1% of newborns hospitalized received at least one off-label drug [ 27 ]. In Estonia, 97% of hospitalized newborns receive two extemporaneous preparation products on average [ 28 ].…”

Section: Resultsmentioning

confidence: 99%

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

et al. 2023

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Extemporaneous preparations are still widely prescribed for pediatric patients with special treatments of certain doses and/or combinations of drugs. Several problems related to extemporaneous preparations have been linked to the incidence of adverse events or a lack of therapeutic effectiveness. Developing nations are facing the challenges of compounding practices. The prevalence of compounded medication in developing nations must be explored to determine the urgency of compounding practices. Furthermore, the risks and challenges are described and explained through investigation and collection of numerous scientific articles from reputable databases, including Web of Science, Scopus, and PubMed. Pediatric patients need compounded medication related to the appropriate dosage form and dosage adjustment. Notably, it is important to observe extemporaneous preparations in order to provide patient-oriented medication.

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Section: Resultsmentioning

confidence: 99%

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

et al. 2023

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“…Nir 6,20,35 . Os medicamentos não licenciados, por sua vez, são menos prescritos, visto que 23,9% desses pacientes receberam ao menos um medicamento não licenciado 6 .…”

Section: Prevalência Do Uso De Medicamentos Off-label E Não Licenciadosunclassified

Medicamentos off-label e não licenciados no âmbito pediátrico: uma revisão descritiva dos últimos dez anos

Balsan

Gobetti

Garcia

2023

CBR

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A falta de medicamentos contendo bulas prevendo o tratamento de pacientes pediátricos representa um problema frequentemente observado em hospitais, principalmente nos setores de unidade de terapia intensiva (UTI) pediátrica e neonatais. Sabe-se que, para que um tratamento seja considerado seguro e eficaz, uma série de estudos clínicos são necessários, no entanto, relata-se um baixo número dessas pesquisas envolvendo crianças, principalmente devido a questões éticas que dificultam a condução das mesmas. Assim, poucos são os medicamentos que provam ser adequados para o tratamento desses pacientes, tornando necessário recorrer ao uso de medicamentos off-label e não licenciados. Os medicamentos são classificados como off-label quando seu uso se dá de maneira que difere de suas especificações aprovadas, por sua vez, produtos não licenciados são classificados desta forma por não possuírem aprovação para sua comercialização no país ou não possuírem comprovação de segurança e eficácia. O preparo de protocolos de estudo organizados, relato de informações aos pais e à criança de maneira clara e objetiva, aproximação entre pesquisadores e pais para o estabelecimento de uma relação de confiança e a condução das pesquisas em momentos de disponibilidade da família demonstram-se estratégias importantes para facilitar a realização dos ensaios clínicos.

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Prescription of off-label and unlicensed medication for newborns hospitalized in the Intensive Care Unit

Santos,

Iser

et al. 2024

Rev. paul. pediatr.

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Objective: To analyze the prevalence of off-label and unlicensed prescriptions for a population of neonates admitted to the Neonatal Intensive Care Unit in a hospital in southern Santa Catarina. Methods: Observational study with a cross-sectional design. All neonates admitted to the Intensive Care Unit during the period from March 2020 to March 2021 were included. Data collection was performed through a questionnaire made by the authors and the classification of drugs based on the Electronic Drug Description (Bulário Eletrônico) of the Brazilian Health Regulatory Agency and Drug Dex-Micromedex. Results: Data from 296 neonates were evaluated. The prevalence was 50,7% for prescribing off-label medications and 37,2% for unlicensed medications. The use of drugs was higher in preterm neonates, with low birth weight, 1st minute Apgar between 6–8, 5th minute Apgar between 7–8, and in need of invasive procedures. The most used off-label drugs were ampicillin, gentamicin and fentanyl (92.6, 92.0 and 26.6%, respectively), whereas the most used unlicensed drugs were caffeine, phenobarbital and bromopride (78.1, 16.3 and 10.9%, respectively). Conclusions: This study showed a large percentage of prescriptions made in the off-label (50.7%) and unlicensed (37.2%) form in the Neonatal Intensive Care Unit, corroborating the worrying world scenario. The most exposed neonates were precisely the most vulnerable ones and, among the most commonly prescribed medications, ampicillin and gentamicin stood out in off-label form and caffeine in unlicensed form.

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Use of Off-Label Medications in a Neonatal Intensive Care Unit

Cited by 3 publications

References 15 publications

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

Medicamentos off-label e não licenciados no âmbito pediátrico: uma revisão descritiva dos últimos dez anos

Prescription of off-label and unlicensed medication for newborns hospitalized in the Intensive Care Unit

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