Abstract
ABSTRACTObjective: 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.
Highlights
According to the World Health Organization (WHO), unsafe practices and medication errors are two of the main causes of preventable damage to health systems worldwide.[1]
In 2017, the Brazilian Ministry of Health published a document on pharmaceutical assistance in Pediatrics, which showed the little participation of children in research, with only 8% of the total number of studies related to medicines, both in the global scenario and in Brazil.[7]
The results of the present study show that a large part of the sample was exposed to OL medications, both by Agência Nacional de Vigilância Sanitária (ANVISA) and the Food and Drugs Administration (FDA), (98.1% versus 78.5%), corroborating a series of research throughout the world that reveal figures as large as those evidenced in our prescriptions
Summary
According to the World Health Organization (WHO), unsafe practices and medication errors are two of the main causes of preventable damage to health systems worldwide.[1]. Therapy with off-label (OL) medications is included in this scenario and occurs when a drug is prescribed under conditions different from those recommended in the drug prescription leaflet, regarding therapeutic indication, route and frequency of administration, dosage, patient’s age, and presentation.[3] Despite this, the use of OL can be considered legal unless it violates ethical guidelines or national security regulations,[4] and is often performed by doctors focused on the individual benefit of patients, especially in populations that are not well represented in clinical trials, such as children and pregnant women.[5]. The insufficiency of scientific basis for pharmacokinetics and pharmacodynamics of drugs is evident for this group of people, facilitating the emergence of serious and unpredictable adverse reactions,[8] especially in view of the vulnerability in which NBs are in NICU
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