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Italian Journal of Pediatrics
Published in: Italian Journal of Pediatrics 1/2017

Open Access 01-12-2017 | Research

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

Authors: A. Girardi, S. Galletti, E. Raschi, A. Koci, E. Poluzzi, G. Faldella, F. De Ponti

Published in: Italian Journal of Pediatrics | Issue 1/2017

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Abstract

Background

Drug 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.

Methods

Medical 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.

Results

A 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.

Conclusions

ELBW 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.
Literature
1.
2.
Girardi A, Raschi E, Galletti S, Poluzzi E, Faldella G, Allegaert K, De Ponti F. Drug-induced renal damage in preterm neonates: state of the art and methods for early detection. Drug Saf. 2015;38:535–51.CrossRefPubMedPubMedCentral
3.
Cuzzolin L, Agostino R. Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study. Eur J Clin Pharmacol. 2016;72(1):117–23.CrossRefPubMed
4.
Conroy S, McIntyre J. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med. 2005;10:115–22.CrossRefPubMed
5.
Krzyzaniak N, Pawlowska I, Bajorek B. Review of drug utilization patterns in NICUs worldwide. J Clin. Pharm. Ther. 2016;41(6):612–20.CrossRefPubMed
6.
7.
8.
Manzoni P, Rizzollo S, Decembrino L, Ruffinazzi G, Rossi RA, Gallo E, Stolfi I, Mostert M, Stronati M, Farina D. Recent advances in prevention of sepsis in the premature neonates in NICU. Early Hum Dev. 2011;87 Suppl 1:S31–3.CrossRefPubMed
9.
Mitha A, Foix-L’Helias L, Arnaud C, Marret S, Vieux R, Aujard Y, Thiriez G, Larroque B, Cambonie G, Burguet A, Boileau P, Roze JC, Kaminski M, Truffert P, Ancel PY. Neonatal infection and 5-year neurodevelopmental outcome of very preterm infants. Pediatrics. 2013;132:e372–80.CrossRefPubMed
10.
Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006;117:1979–87.CrossRefPubMed
11.
Neubert A, Lukas K, Leis T, Dormann H, Brune K, Rascher W. Drug utilisation on a preterm and neonatal intensive care unit in Germany: a prospective, cohort-based analysis. Eur J Clin Pharmacol. 2010;66:87–95.CrossRefPubMed
12.
Goncalves AC, Reis AM, Gusmao AC, Bouzada MC. Drug utilisation profile in the neonatal unit of a university hospital: a prospective observational study in Brazil. Int J Clin. Pharm. 2015;37(4):645–55.CrossRefPubMed
13.
Laforgia N, Nuccio MM, Schettini F, Dell’aera M, Gasbarro AR, Dell’erba A, Solarino B. Off-label and unlicensed drug use among neonatal intensive care units in Southern Italy. Pediatr Int. 2014;56:57–9.CrossRefPubMed
14.
Haslund-Krog S, Mathiasen R, Christensen HR, Holst H. The impact of legislation on drug substances used off-label in paediatric wards--a nationwide study. Eur J Clin Pharmacol. 2014;70:445–52.CrossRefPubMed
15.
Kieran EA, O’Callaghan N, O’Donnell CP. Unlicensed and off-label drug use in an Irish neonatal intensive care unit: a prospective cohort study. Acta Paediatr. 2014;103:e139–42.CrossRefPubMed
16.
Leroux S, Zhao W, Betremieux P, Pladys P, Saliba E, Jacqz-Aigrain E. Therapeutic guidelines for prescribing antibiotics in neonates should be evidence-based: a French national survey. Arch Dis Child. 2015;100:394–8.CrossRefPubMed
17.
Schulman J, Dimand RJ, Lee HC, Duenas GV, Bennett MV, Gould JB. Neonatal intensive care unit antibiotic use. Pediatrics. 2015;135:826–33.CrossRefPubMed
18.
19.
Kaufman D, Boyle R, Hazen KC, Patrie JT, Robinson M, Donowitz LG. Fluconazole prophylaxis against fungal colonization and infection in preterm infants. N Engl J Med. 2001;345:1660–6.CrossRefPubMed
20.
Manzoni P, Stolfi I, Pugni L, Decembrino L, Magnani C, Vetrano G, Tridapalli E, Corona G, Giovannozzi C, Farina D, Arisio R, Merletti F, Maule M, Mosca F, Pedicino R, Stronati M, Mostert M, Gomirato G. A multicenter, randomized trial of prophylactic fluconazole in preterm neonates. N Engl J Med. 2007;356:2483–95.CrossRefPubMed
21.
Kaguelidou F, Pandolfini C, Manzoni P, Choonara I, Bonati M, Jacqz-Aigrain E. European survey on the use of prophylactic fluconazole in neonatal intensive care units. Eur J Pediatr. 2012;171:439–45.CrossRefPubMed
22.
Pandolfini C, Marco S, Paolo M, Maurizio B. The use of ciprofloxacin and fluconazole in Italian neonatal intensive care units: a nationwide survey. BMC Pediatr. 2013;13:5.CrossRefPubMedPubMedCentral
23.
Askenazi DJ, Koralkar R, Hundley HE, Montesanti A, Patil N, Ambalavanan N. Fluid overload and mortality are associated with acute kidney injury in sick near-term/term neonate. Pediatr Nephrol. 2013;28:661–6.CrossRefPubMed
24.
Koralkar R, Ambalavanan N, Levitan EB, McGwin G, Goldstein S, Askenazi D. Acute kidney injury reduces survival in very low birth weight infants. Pediatr Res. 2011;69:354–8.CrossRefPubMed
25.
Taber SS, Pasko DA. The epidemiology of drug-induced disorders: the kidney. Expert Opin Drug Saf. 2008;7:679–90.CrossRefPubMed
26.
Pacifici GM. Clinical pharmacology of furosemide in neonates: a review. Pharmaceuticals (Basel). 2013;6:1094–129.CrossRef
27.
Vieux R, Fresson J, Guillemin F, Hascoet JM. Perinatal drug exposure and renal function in very preterm infants. Arch Dis Child Fetal Neonatal Ed. 2011;96:F290–5.CrossRefPubMed
28.
Safina AI, Daminova MA, Abdullina GA. Acute kidney injury in neonatal intensive care: Medicines involved. Int J Risk Saf Med. 2015;27 Suppl 1:S9–S10.CrossRefPubMed
29.
Elmas AT, Tabel Y, Elmas ON. Serum cystatin C predicts acute kidney injury in preterm neonates with respiratory distress syndrome. Pediatr Nephrol. 2013;28:477–84.CrossRefPubMed
30.
Kandasamy Y, Smith R, Wright IM. Measuring cystatin C to determine renal function in neonates. Pediatr Crit Care Med. 2013;14:318–22.CrossRefPubMed
31.
Sarafidis K, Tsepkentzi E, Agakidou E, Diamanti E, Taparkou A, Soubasi V, Papachristou F, Drossou V. Serum and urine acute kidney injury biomarkers in asphyxiated neonates. Pediatr Nephrol. 2012;27:1575–82.CrossRefPubMed
32.
Walker MW, Clark RH, Spitzer AR. Elevation in plasma creatinine and renal failure in premature neonates without major anomalies: terminology, occurrence and factors associated with increased risk. J Perinatol. 2011;31:199–205.CrossRefPubMed
33.
Stoltz SE, Ohlund I, Ahlsson F, Engstrom E, Fellman V, Hellstrom A, Kallen K, Norman M, Olhager E, Serenius F, Domellof M. Nutrient intakes independently affect growth in extremely preterm infants: results from a population-based study. Acta Paediatr. 2013;102:1067–74.
Metadata
Title
Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unit
Authors
A. Girardi
S. Galletti
E. Raschi
A. Koci
E. Poluzzi
G. Faldella
F. De Ponti
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Italian Journal of Pediatrics / Issue 1/2017
Electronic ISSN: 1824-7288
DOI
https://doi.org/10.1186/s13052-017-0354-z

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