Drugs In Neonatal Intensive Care Units Research Articles

A LC–MS/MS method for the quantification of caffeine, betamethasone, clonidine and furosemide in cerebrospinal fluid of preterm infants

BackgroundNewborns, admitted to the Neonatal Intensive Care Unit (NICU), are exposed to a large number of medications, the majority of which are not labeled for use in infants, especially in preterm newborns, because clinical trials on their benefits and harms are lacking. There is a huge gap in knowledge on pharmacokinetic (PK) data in sick preterm infants, including that of drug penetration to cerebrospinal fluid (CSF). One of the issues is related to the lack of reliable analytical methods for the measurement of drugs in CSF. MethodsIn this paper we describe a specific and sensitive LC–MS/MS method for the simultaneous quantification in CSF of four commonly prescribed drugs in NICUs: caffeine, betamethasone, clonidine and furosemide. ResultsThe method was validated following EMA guidelines and applied to several CSF samples of preterm infants with post-hemorrhagic ventricular dilatation in which a ventricular access device was applied. The range of the concentrations of the four drugs measured in the CSF was wide. ConclusionsOur method can be considered useful for further clinical studies to describe the PK aspects of these drugs in neonatal medicine.

Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran

BackgroundMany newborns may need to be hospitalized and receive drugs during the first days of their lives. These drugs are fundamentally prescribed as off-label and unlicensed. This study aimed to investigate the amount of these kinds of drugs administered in the Neonatal Intensive Care Units (NICUs) of Abuzar and Imam Khomeini Teaching Hospitals in Ahvaz, Iran.MethodsThis was a 3-month descriptive, cross-sectional study with retrospective nature in which 193 hospitalized newborns were studied. Demographic data were extracted from the patients’ files. The drugs were classified as off-label, unlicensed or licensed according to the Pediatric & Neonatal Dosage Handbook (Lexicomp®, 22nd Edition).ResultsIn total, 1049 prescriptions were registered for the 193 hospitalized newborns (term and preterm). For each newborn, the mean numbers of prescriptions and drugs received were 5.4 and 4.5, respectively. The mean numbers of prescriptions and drugs were greater for preterm newborns.Of the total 1049 prescriptions, 38.1% were off-label and 1.9% were unlicensed. Of the 193 newborns, 85% received at least one off-label or unlicensed prescription. Off-label prescriptions were mostly related to dose (44.8%) and dosing interval (36.5%). Most off-label drugs were antibiotics (mainly Gentamicin). Albuterol was used off-label in 100% of the cases.ConclusionsThe results of the present study show that the prescription of off-label and unlicensed drugs in NICUs is as high in Iran as in other countries. This suggests that it is necessary to provide information to neonatologists to decrease the prescription of off-label and unlicensed drugs.

Use of off-label and unlicensed medicines in neonatal intensive care.

PurposeTo evaluate the use of off-label and unlicensed medicines in a neonatal intensive care unit (NICU) of a teaching maternity hospital specialized in high risk pregnancy.MethodsA prospective cohort study was conducted between August 2015 and July 2016. All newborns admitted to the NICU who had at least one medication prescribed and a hospital stay longer than 24 hours were included. The classification of off-label and unlicensed drugs for the neonatal population was done according to the information of Food and Drug Administration.ResultsA total of 17421 medication items were analyzed in 3935 prescriptions of 220 newborns. The proportion of newborns exposed to off-label drugs was 96.4%, and to unlicensed medicines was 66.8%. About one-half (49.3%) of the medication items were off-label and 24.6% were unlicensed. The main reason for off-label and unlicensed classification was, respectively, frequency of administration and the administration of adaptations of pharmaceutical forms.ConclusionsAlthough there are actions to encourage the development of pharmacological studies with neonates, this study observed a high rate of prescription and exposure of newborns to off-label and unlicensed drugs in NICUs and pointed out areas of neonatal therapy that require scientific investment.

O-103 Sedation And Analgesia For Neonates In Nicus Across Europe: The Europain Survey

<h3>Background</h3> Pain and stress induced by mechanical ventilation, invasive procedures, or painful diseases supports the use of sedation/analgesia (S/A) in newborns admitted to Neonatal Intensive Care Units (NICUs). To date, these practices have not been studied at a large scale. <h3>Objective</h3> To determine current clinical practices regarding the use of S/A drugs in NICUs across Europe. <h3>Methods</h3> This epidemiological observational study on bedside clinical practices regarding S/A collected data for all neonates in participating NICUs until the infant left the unit (discharge, death, transfer) or for up to 28 days. Data collection occurred via an online database for 1 month at each NICU. All neonates up to 44 weeks gestation were included. <h3>Results</h3> From October 2012 to June 2013, 243 NICUs from 18 European countries collected data on 6680 eligible neonates. Of these, 2142 received tracheal ventilation (TV), 1496 non-invasive ventilation (NIV) and 3042 only spontaneous ventilation (SV). The median (IQR) gestational age of TV, NIV and SV neonates were 32.1 (28.1–37.4), 33.6 (31.0–36.6) and 37.9 (35.0–39.9), respectively (p &lt; 0.001). Overall, more TV neonates [81.5% (n = 1746)] received S/A drugs than NIV neonates [17.8% (n = 266)] and SV neonates [9.3% (n = 282)]; p &lt; 0.001. Fig. shows the rate of S/A use by country; table shows S/A drugs used. <h3>Conclusions</h3> Most ventilated but few non-ventilated neonates (NIV and SV) receive S/A therapy in European NICUs. Wide variations in S/A use, drugs used, and mode of administration (continuous, bolus, or both) exist among countries.