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 6 publications

(10 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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“…Considering the Anatomic Therapeutic Chemical (ATC) classification for drugs, where medications are divided into different groups based on the organ or system they act on and their chemical, pharmacological, and therapeutic properties, the group of systemic anti-infective drugs and the group of drugs acting on the nervous system were the most commonly used in these studies. Additionally, the studies also mentioned the considerable use of drug groups that act on the digestive system and the cardiovascular system 4,32,33 .…”

Section: Off-label Drug Usementioning

confidence: 99%

“…and the Food and Drug Administration (FDA) 4,32 , but one study only considered the FDA criteria 33 . Regarding the use of off-label and unlicensed drugs, it is noteworthy that clinical research in the field of pediatrics is significantly hindered by bioethical issues, leading to limited reliable evidence regarding pharmacological treatments.…”

Section: Off-label Drug Usementioning

confidence: 99%

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Neonatal ICU therapy: a literature review on pharmacotherapies

Brandão,

Pinheiro,

Maia

et al. 2023

Braz. J. Develop.

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INTRODUCTION: The neonatal period is an age group of vulnerability, which is subject to adverse effects related to conventional drug treatments and therapies, many drugs are empirically applied in the neonatal ICU (NICU), in off-label or non-licensed ways, currently the scientific basis on pediatric pharmacological assistance is scarce, constituting an unpredictable scenario of adverse and severe drug reactions. OBJECTIVE: To analyze the main pharmacological practices in the neonatal ICU, observing the possible effects on the newborn patient. METHODOLOGY: literature review that used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. The search for articles was carried out in PubMed, SciELO and LILACS databases, applying descriptors from Descritores em Ciências da Saúde (DeCS) and Medical Subject Headings (MeSH). RESULTS: 415 articles were found and 26 were included in the study. It was noted that there is a high prevalence of overdoses and unnecessary prolongation of antibiotic therapy, adverse effects linked to bacterial resistance and alteration of the newborn’s (NB) microbiota may occur, generally these drugs were used in the scenario of neonatal sepsis and in an off-label way, vancomycin stood out as the most widely used antibiotic among the studies. The NB’s respiratory problems were pharmacologically treated with exogenous surfactant, propofol, hydrocortisone and milrinone, the clinical situations of use include Respiratory Distress Syndrome in Neonates and sedation for intubation. Painful procedures are common in the NICU, requiring pharmacological measures such as the use of analgesics and sedatives, including fentanyl, morphine, dipyrone, non-steroidal anti-inflammatory drugs and benzodiazepines, the safe application is also difficulty with these medications. Local anesthetics, such as lidocaine, are the most used for surgical pain, epidural anesthesia helps to reduce surgical stress, and topical anesthetics are useful for pain caused by skin barrier rupture. The group of drugs most used in an off-label way, according to the Anatomic Therapeutic Chemical (ATC) classification, were the group of anti-infectives for systemic use and drugs that act on the nervous system. CONCLUSION: the need for more scientific depth in the context of pharmacology at the NICU became extremely explicit during the study’s development, the lack of consensus for appropriate medical prescriptions leads to the need for greater care when prescribing for neonates, considering the inherent characteristics of the organism of these patients that alter the pharmacokinetics and pharmacodynamics of medications.

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

Cited by 6 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

Neonatal ICU therapy: a literature review on pharmacotherapies

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