Therapeutic challenges in neonates

Zisovska, Elizabeta and Slaveska-Raicki, Renata (2019) Therapeutic challenges in neonates. In: VI kongres udruzenja za preventivnu pedijatriju Srbije, 12-14 Apr 2019, Belgrade, Serbia.

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There is no other age as challenging as neonatal, due to the immaturity of
organs and the unpredictable pharmacokinetics, like the mode of
application, biotransformation, distribution and elimination. The reasons
for this challenge are specific receptor reactions, narrow therapeutic
window, and burden of diseases specific only for this age, therefore lack of
evidence for drug efficacy. The prescription of medicines in neonate is in
direct relation of the gestational age, postnatal age, birth weight,
associated morbidity. Many of the drugs are used as off-label, or even
unlicensed, thus creating higher risk of medical errors, especially in NICU.
These medicines can be used out of age, regimen, indication, or route of
Cilj rada:
The aim of this paper is to present the extent to which off-label and/or
unlicensed medicines are used in neonatal unit within
Obstetric&Gynecology Clinic in Skopje.
Materijal i
This was an observational, cohort study, including 200 healthy newborns,
term or near-term, (control group) and 100 newborns, receiving therapy,
and non-dependent of intensive care. Intravenous replacement solutions
and blood products were not included.
Results: there were 176 prescriptions in total in the investigated group;
148/176 (or 84,1%) of them were according to the prescribed drug
guidelines, and 15,9% were off-label. In the control group, there were 110
prescriptions and only 3,6% were off-label. The difference had high
statistical significance. Majority of the off-label reasons were use out of
dose, indication, and age. The mostly prescribed off-label medicines were
Gentamicin, Cefotaxime, Amikacin, Furosemide, Dexamethasone.
Zaključak: It is worth mentioning that this is a part of a broader study, including
newborns with more severe diseases, where much more prescriptions aregiven, and the risk of toxicity is manifold increased. These data show only
the iceberg of the problem of neonatal pharmacotherapy. More detailed
analysis will highlight this issue and give more information in terms of
efficient neonatal treatment.
Ključne reči: newborn, off-label medicine, therapy

Item Type: Conference or Workshop Item (Poster)
Subjects: Medical and Health Sciences > Clinical medicine
Divisions: Faculty of Medical Science
Depositing User: Elizabeta Zisovska
Date Deposited: 25 Oct 2019 08:27
Last Modified: 25 Oct 2019 08:27

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