Changing Pattern of Drug Utilization in a Neonatal Intensive Care Unit

Aranda, Jacob V.; Clarkson, Susanna; Collinge, Judith M.

doi:10.1055/s-2007-1000047

Cited by 14 publications

(15 citation statements)

References 4 publications

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“…The basic urine-forming unit of the kidney is the nephron, which consists of a filtering apparatus, the glomerulus, connected to a long tubular portion that reabsorbs and conditions the glomerular ultrafiltration. Furosemide increases the delivery of solutes out of the loop of Henle, is a sulphonamide derivative, and is the most commonly used diuretic in the newborn period [1,2]. Given in excessive amounts, furosemide can lead to dehydration and electrolytic depletion [3].…”

Section: Introductionmentioning

confidence: 99%

Clinical Pharmacology of Furosemide in Neonates: A Review

Pacifici

2013

Pharmaceuticals

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Furosemide is the diuretic most used in newborn infants. It blocks the Na+-K+-2Cl− symporter in the thick ascending limb of the loop of Henle increasing urinary excretion of Na+ and Cl−. This article aimed to review the published data on the clinical pharmacology of furosemide in neonates to provide a critical, comprehensive, authoritative and, updated survey on the metabolism, pharmacokinetics, pharmacodynamics and side-effects of furosemide in neonates. The bibliographic search was performed using PubMed and EMBASE databases as search engines; January 2013 was the cutoff point. Furosemide half-life (t1/2) is 6 to 20-fold longer, clearance (Cl) is 1.2 to 14-fold smaller and volume of distribution (Vd) is 1.3 to 6-fold larger than the adult values. t1/2 shortens and Cl increases as the neonatal maturation proceeds. Continuous intravenous infusion of furosemide yields more controlled diuresis than the intermittent intravenous infusion. Furosemide may be administered by inhalation to infants with chronic lung disease to improve pulmonary mechanics. Furosemide stimulates prostaglandin E2 synthesis, a potent dilator of the patent ductus arteriosus, and the administration of furosemide to any preterm infants should be carefully weighed against the risk of precipitation of a symptomatic patent ductus arteriosus. Infants with low birthweight treated with chronic furosemide are at risk for the development of intra-renal calcifications.

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Section: Introductionmentioning

confidence: 99%

Clinical Pharmacology of Furosemide in Neonates: A Review

Pacifici

2013

Pharmaceuticals

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“…In contrast to descriptions of more singular intensive care unit (ICU) therapies, such as mechanical ventilation and extracorporeal membrane oxygenator therapy, for which large-scale epidemiologic studies have been performed, [4][5][6][7] descriptions of the extent of pharmacotherapy in critical illness are limited. [8][9][10][11][12] Critically ill children receive more medications than other hospitalized children, [13][14][15][16] but there is little information quantifying drug orders written, numbers of different medications ordered, and drug administration. In order to better understand the nature of pharmacotherapy in pediatric critical illness, we prospectively evaluated pharmacotherapy in a cohort of critically ill children admitted to a university-affiliated pediatric ICU.…”

Section: Introductionmentioning

confidence: 99%

Pharmacotherapy in Pediatric Critical Illness

et al. 2009

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Pharmacotherapy is an active component in the practice of pediatric critical care medicine. We demonstrated that increasing numbers of ordered medications, drug orders, and drug administrations were associated with increasing duration of ICU therapies and the length of ICU stay. These data underscore the potential importance of improved safety and efficacy of medicines used to treat critically ill children.

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“…1 Despite neonatal medicine’s history of catastrophic adverse events resulting from inadequate study of drugs prior to their widespread use, 2–5 the majority of drugs used in neonates have not undergone sufficient study to receive Food and Drug Administration (FDA) labeling that is safe and effective when applied to this population. 6–10 …”

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Drug Labeling and Exposure in Neonates

et al. 2014

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Importance Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. Neonatal information in labeling is even scarcer because neonates comprise a vulnerable subpopulation for which end point development is lagging and studies are more challenging. Objective To quantify progress made in neonatal studies and neonatal information in product labeling as result of recent legislation. Design 1. Cohort of neonatal drug studies; and 2. Cohort of infants exposed to these drugs.. Setting 1. Neonatal drug studies: FDA website; 2. National review: infants admitted to a neonatal intensive care unit (NICU) Participants 1) We identified drug studies between 1997 and 2010 that included neonates as a result of pediatric legislation using information available on the FDA website. We determined what studies were published in the medical literature, the legislation responsible for the studies, and the resulting neonatal labeling changes. 2) We then examined the use of these drugs in neonates admitted to 290 NICUs (the Pediatrix Data Warehouse) in the United States from 2005–2010. Exposures Infants exposed to a drug studied in neonates as identified by the FDA website Main outcome measures Number of drug studies with neonates and rate of exposure per 1000 admission among infants admitted to a NICU Results In a review of the FDA databases, we identified 28 drugs studied in neonates and 24 related labeling changes. Forty-one studies encompassed the 28 drugs, and 31 (76%) of these were published. Eleven (46%) of the 24 neonatal labeling changes established safety and effectiveness. In a review of a cohort of 446,335 hospitalized infants, we identified 399 drugs used and 1,525,739 drug exposures in the first 28 postnatal days. Thirteen (46%) of the 28 drugs studied in neonates were not used in NICUs; 8 (29%) were used in fewer than 60 neonates. Of the drugs studied, ranitidine was used most often (15,627 neonates, 35 exposures per 1000 admissions). Conclusions and Relevance Few drug labeling changes made under pediatric legislation include neonates. Most drugs studied are either not used or rarely used in U.S. NICUs. Strategies to increase the study of safe and effective drugs for neonates are needed.

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Changing Pattern of Drug Utilization in a Neonatal Intensive Care Unit

Cited by 14 publications

References 4 publications

Clinical Pharmacology of Furosemide in Neonates: A Review

Clinical Pharmacology of Furosemide in Neonates: A Review

Pharmacotherapy in Pediatric Critical Illness

Drug Labeling and Exposure in Neonates

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