Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unit

Abstract

BackgroundDrug use in preterm neonates admitted to Neonatal Intensive Care Unit (NICU) has been investigated, so far, in terms of unauthorized or off-label use; very little is known on the use of combinations of different active substances, which is frequently required in this population (prophylaxis of infections, treatment of concomitant diseases). The aim of this study was to describe the most common patterns of drug use in an Italian NICU, focusing on those with nephrotoxic potential.MethodsMedical records of preterm neonates (<37 weeks of gestational age) weighing less than 1,500 g at birth and admitted to an Italian NICU were scrutinized in a 3-year retrospective investigation. Analysis included drug exposure, duration of therapies, co-administration of drugs with potential renal side effects; also daily protein supplement was calculated from parenteral nutrition.ResultsA cohort of 159 preterm neonates was selected; 68 were born weighing less than 1,000 g (extremely low birth weight infants, ELBW, Group A), 91 weighed between 1,000 and 1,500 g at birth (Group B). Compared to Group B, neonates of Group A were more likely to receive pharmacological treatments: the most used drugs were antibiotics (especially ampicillin and amikacin, p = .07 and p < .001, respectively), antifungals (especially fluconazole, p < .001), and diuretics (especially furosemide, p < .001). Analysis of co-administration of drugs with potential nephrotoxicity showed ampicillin and amikacin as the most reported combination (94.1% of Group A and 31.9% of Group B), the combination of furosemide with antibacterials (ampicillin or amikacin) was also frequently reported, with average period of combination shorter than 2 days.ConclusionsELBW infants were exposed to a higher number of drugs compared to other neonates and were more likely to receive associations of drugs with nephrotoxic potential (e.g. furosemide and amikacin), though only for short cycles. Further studies should evaluate the safety profile (especially potential renal side effects) related to most commonly used combinations.

Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit

“…In the present study, antibiotics were the most commonly used off-label medicines compared to the other classes of medicines. This was similar finding with that of study reports from Iran and Italy [3,24]. However, it was different from a study conducted in Netherlands which reported that blood products were the top class of medicines used in an off-label manner [20].…”

“…The use of off-label and unlicensed medicines was found to differ by the gestational age of the neonates. Many studies elsewhere in the world reported high rate of off-label [11,12,22,24] and unlicensed [11] medicine use among pre-term neonates. Despite the number of post-term neonate were very small in our study, off-label prescriptions were relatively higher for post-term and preterm neonates where (8/8) and (43/45) of the postterm and pre-term neonates were exposed to at least one off-label medicines respectively.…”

Review of Drug Utilization Studies in Neonatal Units: A Global Perspective

“…Europe (24 studies) [7,13,20,25,26,29,31,35,37,[42][43][44]50,59,62,63,65,67,68,71,[74][75][76]79] caffeine (18 studies), gentamicin (17 studies), ampicillin (11 studies), furosemide (9 studies), multivitamins (9 studies), vitamin K (11 studies), benzylpenicillin (8 studies), amikacin (6 studies), morphine (5 studies), paracetamol (6 studies)…”

Advances in pediatrics in 2017: current practices and challenges in allergy, endocrinology, gastroenterology, genetics, immunology, infectious diseases, neonatology, nephrology, neurology, pulmonology from the perspective of Italian Journal of Pediatrics

“…Thus, antibiotics are the most frequently prescribed medicines, followed by drugs for respiratory and nervous diseases in neonates, especially if with a gestational age below 32 weeks and/or birth weight < 2500 g. Almost 90% of the drugs used in neonatal intensive care units (NICUs) are off-label or unlicensed [ 101 ] and they are administered intravenously [ 102 ]. Girardi et al have recently evaluated the drug use in neonates with low and extremely low birth weight at an Italian NICU [ 103 ]. They found that, compared to neonates with low birth weight, babies with very low birth weight were exposed to a higher number of drugs, mainly antibiotics, antifungals, and diuretics, and received more frequently associations of potentially nephrotoxic drugs.…”