Research on medication use in the neonatal intensive care unit

References

• Allegaert K, van Den Anker J. Neonatal drug therapy: the first frontier of therapeutics for children. Clin Pharmacol Ther. 2015;98:288–297.
   PubMed Web of Science ®Google Scholar
• Ward RM, Benjamin D, Barrett JS, et al. Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates. Pediatr Res. 2017;81:692–711.
   PubMed Web of Science ®Google Scholar
• Allegaert K, Simons SHP, Tibboel D, et al. Non-maturational covariates for dynamic systems pharmacology models in neonates, infants, and children: filling the gaps beyond developmental pharmacology. Eur J Pharm Sci. 2017;109S:S27–S31.
   PubMedGoogle Scholar
• Coppini R, Simons SHP, Mugelli A, et al. Clinical research in neonates and infants: challenges and perspectives. Pharmacol Res. 2016;108:80–87.
   PubMed Web of Science ®Google Scholar
• Magalhaes J, Rodrigues AT, Roque F, et al. Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review. Eur J Clin Pharmacol. 2015;71:1–13.
   PubMed Web of Science ®Google Scholar
• Turner MA. Neonatal drug development. Early Hum Dev. 2011;87:763–768.
   PubMed Web of Science ®Google Scholar
• Allegaert K, Smits A, van den Anker JN. Drug evaluation studies in neonates: how to overcome the current limitations. Expert Rev Clin Pharmacol. 2018;11:387–396.
   PubMed Web of Science ®Google Scholar
• Rosli R, Dali AF, Abd Aziz N, et al. Drug utilization on neonatal wards: a systematic review of observational studies. Front Pharmacol. 2017;8:27.
   PubMed Web of Science ®Google Scholar
• Avorn J. The psychology of clinical decision making - implications for medication use. N Engl J Med. 2018;378:689–691.
   PubMed Web of Science ®Google Scholar
• Krzyzaniak N, Pawlowska I, Bajorek B. Review of drug utilization patterns in NICUs worldwide. J Clin Pharm Ther. 2016;41:612–620.
   PubMed Web of Science ®Google Scholar
• Laine N, Kaukonen AM, Hoppu K, et al. Off-label use of antimicrobials in neonates in a tertiary children’s hospital. Eur J Clin Pharmacol. 2017;73:609–614.
   PubMed Web of Science ®Google Scholar
• Liem TB, Heerdink ER, Egberts AC, et al. Quantifying antibiotic use in paediatrics: a proposal for neonatal DDDs. Eur J Clin Microbiol Infect Dis. 2010;29:1301–1303.
   PubMed Web of Science ®Google Scholar
• Wilbaux M, Fuch S, Samardzic J, et al. Pharmacometric approaches to personalize use of primarily renally eliminated antibiotics in preterm and term neonates. J Clin Pharmacol. 2016;56:909–935.
   PubMed Web of Science ®Google Scholar
• Sequi M, Campi R, Clavenna A, et al. Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies. Eur J Clin Pharmacol. 2013;69:599–604.
   PubMed Web of Science ®Google Scholar
• Nellis G, Lutsar I, Varendi H, et al. Comparison of two alternative study designs in assessment of medicines utilisation in neonates. BMC Med Res Methodol. 2014;14:89.
   PubMed Web of Science ®Google Scholar
• Metsvaht T, Nellis G, Varendi H, et al. High prevalence in the dosing of commonly used antibiotics revealed by a Europe-wide point prevalence study: implications for research and dissemination. BMC Pediatr. 2015;15:41.
   PubMed Web of Science ®Google Scholar
• Gonçalves AC, Reis AM, Gusmao AC, et al. Drug utilisation profile in the neonatal unit of a university hospital: a prospective observational study in Brazil. Int J Clin Pharm. 2015;37:645–655.
   PubMed Web of Science ®Google Scholar
• Sharanappa M, Vishwanath Y, Lakshminarayana K, et al. Pattern of drug utilisation in neonatal intensive care unit in a tertiary care hospital. Int J Biomed Res. 2015;5:582–584.
   Google Scholar
• Patel Brijal S, Kubavatamita AR, Sondarva Divyesh B, et al. Drug utilization study in neonatal intensive care unit at tertiary care hospital, Rajkot, Gujarat: a prospective study. World J Pharm Pharm Sci. 2015;4:2034–2042.
   Google Scholar
• Lass J, Käär R, Jõgi K, et al. Drug utilisation pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol. 2011;67:1263–1271.
   PubMed Web of Science ®Google Scholar
• Neubert A, Lukas K, Leis T, et al. 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.
   PubMed Web of Science ®Google Scholar
• Chatterjee S, Mandal A, Lyle N, et al. Drug utilization study in a neonatology unit of a tertiary care hospital in eastern India. Pharmacoepidemiol Drug Saf. 2007;16:1141–1145.
   PubMed Web of Science ®Google Scholar
• Suryawanshi S, Suryawanshi P, Pandit V. Drug utilization study in a neonatology unit of a tertiary care hospital in Pune City. World J Pharm Pharm Sci. 2016;5:1236–1246.
   Google Scholar
• Hsieh EM, Hornik CP, Clark RH, et al. Medication use in the neonatal intensive care unit. Am J Perinatol. 2014;31:811–821.
   PubMed Web of Science ®Google Scholar
• Kumar P, Walker JK, Hurt KM, et al. Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications. J Pediatr. 2008;152:412–415.
   PubMed Web of Science ®Google Scholar
• Du W, Warrier I, Tutag Lehr V, et al. Changing patterns of drug utilization in a neonatal intensive care population. Am J Perinatol. 2006;23:279–285.
   PubMed Web of Science ®Google Scholar
• Clark RH, Bloom BT, Spitzer AR, et al. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006;117:1979–1987.
   PubMed Web of Science ®Google Scholar
• Warrier I, Du W, Natarajan G, et al. Patterns of drug utilization in a neonatal intensive care unit. J Clin Pharmacol. 2006;46:449–455.
   PubMed Web of Science ®Google Scholar
• Subash KR, Shanmugapriyan S. A study on prescription of antibiotics utilization in neonatal intensive care at a tertiary center. Int J Med Res Heal Sci. 2015;4:265–268.
   Web of Science ®Google Scholar
• Zingg W, Pfister R, Posfay-Barbe KM, et al. Secular trends in antibiotic use among neonates: 2001–2008. Pediatr Infect Dis J. 2011;30:365–370.
   PubMed Web of Science ®Google Scholar
• Porta A, Hsia Y, Doerholt K, et al. Comparing neonatal and paediatric antibiotic prescribing between hospitals: a new algorithm to help international benchmarking. J Antimicrob Chemother. 2012;67:1278–1286.
   PubMed Web of Science ®Google Scholar
• Salehifar E, Nasehi M, Eslami G, et al. Determination of antibiotics consumption in Buali-Sina Pediatric Hospital, Sari 2010–2011. Iran J Pharm Res. 2014;13:995–1001.
   PubMed Web of Science ®Google Scholar
• Nitsch-Osuch A, Kurpas D, Kuchar E, et al. Antibiotic consumption pattern in the neonatal special care unit before and after implementation of the hospital’s antibiotic policy. In: Pokorsi M, editor. Respiratory Infections. Advances in Experimental Medicine and Biology, Vol. 835. Springer, Cham; 2014. p. 45–51.
   Google Scholar
• Liem TB, Krediet TG, Fleer A, et al. Variation in antibiotic use in neonatal intensive care units in the Netherlands. J Antimicrob Chemother. 2010;65:1270–1275.
   PubMed Web of Science ®Google Scholar
• Nitsch-Osuch A, Marciniak A, Katarzyna Z, et al. Antibiotic consumption pattern in a single neonatal care unit. Family Med Primary Care Rev. 2013;15:552–555.
   Google Scholar
• Grohskopf LA, Huskins WC, Sinkowitz-Cochran RL, et al. Use of antimicrobial agents in United States neonatal and pediatric intensive care patients. Pediatr Infect Dis J. 2005;24:766–773.
   PubMed Web of Science ®Google Scholar
• Ahmad KA, Desai SJ, Bennett MM, et al. Changing antiepileptic drug use for seizures in US neonatal intensive care units from 2005 to 2014. J Perinatol. 2017;37:296–300.
   PubMed Web of Science ®Google Scholar
• Anitha P, Pundarikaksha HP. A prospective study of the pattern of antimicrobial use in neonatal intensive care unit of a tertiary care hospital. Natl J Physiol Pharm Pharmacol. 2018;8:376–380.
   Google Scholar
• Borenstein-Levin L, Synnes A, Grunau RE, et al. Narcotics and sedative use in preterm neonates. J Pediatr. 2017;180:92–98.e1.
   PubMed Web of Science ®Google Scholar
• Burns ML, Stensvold HJ, Risnes K, et al. Inotropic therapy in newborns, a population-based national registry study. Pediatr Crit Care Med. 2016;17:948–956.
   PubMed Web of Science ®Google Scholar
• Arocas Casan V, Cabezuelo Escribano B, Garrido-Corro B, de la Rubia Nieto MA. Off-label and unlicensed drug use in a Spanish neonatal intensive care unit. Farm Hosp. 2017;41:371–381.
   PubMedGoogle Scholar
• Chauthankar SA, Marathe PA, Potey AV, et al. Drug utilization in neonatal intensive care unit of a tertiary-care hospital in Mumbai, India. Indian Pediatr. 2017;54:931–934.
   PubMed Web of Science ®Google Scholar
• Choure MK, Jadhav RR, Padwal SL. Drug utilization study in neonatal intensive care unit at rural tertiary care hospital. Asian J Pharm Clin Res. 2017;10:102–104.
   Google Scholar
• Cuzzolin L, Agostino R. Off-label and unlicensed drug treatments in neonatal intensive care units: an Italian multicentre study. Eur J Clin Pharmacol. 2016;72:117–123.
   PubMed Web of Science ®Google Scholar
• de Souza AS Jr, Dos Santos DB, Rey LC, et al. Off-label use and harmful potential of drugs in a NICU in Brazil: a descriptive study. BMC Pediatr. 2016;16:13.
   PubMed Web of Science ®Google Scholar
• Elmekkawi A, More K, Shea J, et al. Impact of stewardship on inhaled nitric oxide utilization in a neonatal ICU. Hosp Pediatr. 2016;6:607–615.
   PubMedGoogle Scholar
• Flint RB, van Beek F, Andriessen P, et al. Large differences in neonatal drug use between NICUs are common practice: time for consensus? Br J Clin Pharmacol. 2018;84:1313–1323.
   PubMed Web of Science ®Google Scholar
• Girardi A, Galletti S, Raschi E, et al. Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unit. Ital J Pediatr. 2017;43:37.
   PubMed Web of Science ®Google Scholar
• Gonçalves AC, Reis AM, Marçal AC, et al. Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital. Braz J Pharm Sci. 2017;53(3):e00252.
   Web of Science ®Google Scholar
• Hauge C, Stalsby Lungborg C, Mandaliya J, et al. Up to 89% of neonates received antibioitics in cross-sectional Indian study including those with no infections and unclear diagnoses. Acta Paediatr. 2017;106(10):1674–1683.
   PubMed Web of Science ®Google Scholar
• Holzmann-Pazgal G, Khan AM, Northrup TF, et al. Decreasing vancomycin utilization in a neonatal intensive care unit. Am J Infect Control. 2015;43:1255–1257.
   PubMed Web of Science ®Google Scholar
• Jayaram KB, Usha D, Divya VJ. Usage of off-label drugs among preterm babies admitted in a level III neonatal intensive care unit attached to a medical college in Southern Karnataka. J Evol Med Dent Sci. 2017;6:6664–6667.
   Web of Science ®Google Scholar
• Lista G, Fabbri L, Polackova R, et al. The real-world routine use of caffeine citrate in preterm infants: a European postauthorization safety study. Neonatology. 2016;109:221–227.
   PubMed Web of Science ®Google Scholar
• Mazhar F, Akram S, Haider N, et al. Off-label and unlicensed drug use in hospitalized newborns in a Saudi tertiary care hospital: a cohort study. Int J Clin Pharm. 2018;40:700–703.
   PubMed Web of Science ®Google Scholar
• Nir-Neuman H, Abu-Kishk I, Toledano M, et al. Unlicensed and off-label medication use in pediatric and neonatal intensive care units: no change over a decade. Adv Ther. 2018;35:1122–1132.
   PubMed Web of Science ®Google Scholar
• Nzegwu NI, Rychalsky MR, Nallu LA, et al. Implementation of an antimicrobial stewardship program in a neonatal intensive care unit. Infect Control Hosp Epidemiol. 2017;38:1137–1143.
   PubMed Web of Science ®Google Scholar
• Oliver EA, Reagan PB, Slaughter JL, et al. Patterns of empiric antibiotic administration for presumed early-onset neonatal sepsis in neonatal intensive care units in the United States. Am J Perinatol. 2017;34:640–647.
   PubMed Web of Science ®Google Scholar
• Raghuram K, Mukerji A, Young J, et al. Surfactant utilization and short-term outcomes in an era of non-invasive respiratory support in Canadian neonatal intensive care units. J Perinatol. 2017;37:1017–1023.
   PubMed Web of Science ®Google Scholar
• Rana D, Bellflower B, Sahni J, et al. Reduced narcotic and sedative utilization in a NICU after implementation of pain management guidelines. J Perinatol. 2017;37:1038–1042.
   PubMed Web of Science ®Google Scholar
• Schweigertova J, Durisova A, Dolnikova D, et al. Off-label and unlicensed use of medicinal products in the neonatal setting in the Slovak Republic. Pediatr Int. 2016;58:126–131.
   PubMed Web of Science ®Google Scholar
• Shinde AR, Mohite RV, Shinde RV. Pattern of antibiotics utilization in neonatal septicemia: a cross-sectional study from rural tertiary care hospital Western Maharashtra, India. Int J Pharm Pharm Sci. 2017;9:60–63.
   Google Scholar
• Silva J, Flor-de-Lima F, Soares H, et al. Off-label and unlicensed drug use in neonatology: reality in a Portuguese university hospital. Acta Med Port. 2015;28:297–306.
   PubMed Web of Science ®Google Scholar
• Slaughter JL, Stenger MR, Reagan PB, et al. Neonatal histamine-2 receptor antagonist and proton pump inhibitor treatment at United States children’s hospitals. J Pediatr. 2016;174:63–70.e3.
   PubMed Web of Science ®Google Scholar
• Gulati R, Elabiad MT, Talati AJ, et al. Trends in medication use in very low-birth-weight infants in a level 3 NICU over 2 decades. Am J Perinatol. 2016;33:370–377.
   PubMed Web of Science ®Google Scholar
• Zimmerman KO, Smith PB, Benjamin DK, et al. Sedation, analgesia, and paralysis during mechanical ventilation of premature infants. J Pediatr. 2017;180:99–104.
   PubMed Web of Science ®Google Scholar
• Bellu R, de Waal K, Zanini R. Opioids for neonates receiving mechanical ventilation: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2010;95:F241–F251.
   PubMed Web of Science ®Google Scholar
• Allegaert K, Tibboel D, Naulaers G, et al. Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed. Eur J Clin Pharmacol. 2003;59:87–90.
   PubMed Web of Science ®Google Scholar
• Carbajal R, Eriksson M, Courtois E, et al. Sedation and analgesia practices in neonatal intensive care units (EUROPAIN): results from a prospective cohort study. Lancet Respir Med. 2015;3(10):796–812.
   PubMed Web of Science ®Google Scholar
• Schiller RM, Allegaert K, Hunfeld M, et al. Analgesics and sedatives in critically ill newborns and infants: the impact on long-term neurodevelopment. J Clin Pharmacol. 2018;58(Suppl 10):S140–S150.
   PubMed Web of Science ®Google Scholar
• Baarslag MA, Ista E, de Leeuw T, et al. Clinically effective implementation of intravenous paracetamol as primary analgesia after major surgery in neonates and young infants. Arch Dis Child. 2018;103:1168–1169.
   PubMed Web of Science ®Google Scholar
• El-Dib M, Soul JS. The use of phenobarbital and other anti-seizure drugs in newborns. Semin Fetal Neonatal Med. 2017;22(5):321–327.
   PubMed Web of Science ®Google Scholar
• Maitre NL, Smolinsky C, Slaughter JC, et al. Adverse neurodevelopmental outcomes after exposure to phenobarbital and levetiracetam for the treatment of neonatal seizures. J Perinatol. 2013;33(11):841–846.
   PubMed Web of Science ®Google Scholar
• Bashir RA, Espinoza L, Vayalthrikkovil S, et al. Implementation of a neurocritical care program: improved seizure detection and decreased antiseizure medication at discharge in neonates with hypoxic-ischemic encephalopathy. Pediatr Neurol. 2016;64:38–43.
   PubMed Web of Science ®Google Scholar
• Cornet MC, Sands TT, Cilio MR. Neonatal epilepsies: clinical management. Semin Fetal Neonatal Med. 2018;23(3):204–212.
   PubMed Web of Science ®Google Scholar
• Eichenwald EC. Committee on fetus and newborn. Diagnosis and management of gastroesophageal reflux in preterm infants. Pediatrics. 2018;142(1):e20181061.
   PubMed Web of Science ®Google Scholar
• Dermyshi E, Mackie C, Kigozi P, et al. Antacid therapy for gastroesophageal reflux in preterm infants: a systematic review. BMJ Pediatr Open. 2018;2:e000287.
   PubMedGoogle Scholar
• Angelidou A, Bell K, Gupta M, et al. Implementation of a guideline to decrease use of acid-suppressing medications in the NICU. Pediatrics. 2017;140:e20171715.
   PubMed Web of Science ®Google Scholar
• Schmidt B, Roberts RS, Davis P, et al. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006;354:2112–2121.
   PubMed Web of Science ®Google Scholar
• Henderson-Smart DJ, Steer PA. Caffeine versus theophylline for apnea in preterm infants. Cochrane Database Syst Rev. 2010;1:CD000273.
   Google Scholar
• Morton SU, Smith VC. Treatment options for apnoea of prematurity. Arch Dis Child Fetal Neonatal Ed. 2016;101:F352–F356.
   PubMed Web of Science ®Google Scholar
• Hartley C, Goksan S, Poorun R, et al. The relationship between nociceptive brain activity, spinal reflex withdrawal and behaviour in newborn infants. Sci Rep. 2015;5:12519.
   PubMed Web of Science ®Google Scholar
• Lefevere J, Allegaert K. Question: is breastfeeding useful in the management of neonatal abstinence syndrome. Arch Dis Child. 2015;100:414–415.
   PubMed Web of Science ®Google Scholar
• Meador KJ, Baker GA, Browning N, et al. Breastfeeding in children of women taking antiepileptic drugs: cognitive outcomes at age 6 years. JAMA Pediatr. 2014;168:729–736.
   PubMed Web of Science ®Google Scholar
• Smits A, Kulo A, van Den Anker J, et al. The amikacin research program: a stepwise approach to validate dosing regimens in neonates. Expert Opin Drug Metab Toxicol. 2017;13:157–166.
   PubMed Web of Science ®Google Scholar
• Mian P, Flint RB, Tibboel D, et al. Therapeutic drug monitoring in neonates: what makes them unique? Curr Pharm Des. 2017;23:5790–5800.
   PubMed Web of Science ®Google Scholar
• de Man P, Verhoeven BA, Verbrugh HA, et al. van den Anker JN. An antibiotic policy to prevent emergence of resistant bacilli. Lancet. 2000;355:973–978.
   PubMed Web of Science ®Google Scholar
• National Institute for Health, National Library of Medicine. [cited 2018 Sept 11]. Available from: https://clinicaltrials.gov/ct2/show/NCT03247920
   Google Scholar