Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications

Abstract Purpose Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emer...

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Veröffentlicht in:Clinical therapeutics 2015-09, Vol.37 (9), p.1924-1932
Hauptverfasser: Rowe, Stevie, MD, Siegel, David, MD, Benjamin, Daniel K., MD, PhD, MPH
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container_end_page 1932
container_issue 9
container_start_page 1924
container_title Clinical therapeutics
container_volume 37
creator Rowe, Stevie, MD
Siegel, David, MD
Benjamin, Daniel K., MD, PhD, MPH
description Abstract Purpose Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emergency setting can limit therapeutic efficacy and increase drug-related toxic effects for obese children. Few systematic reviews examining PK properties and drug dosing in obese children have been performed. Methods We identified 25 emergency care drugs from the Strategic National Stockpile and Acute Care Supportive Drugs List and performed a systematic review for each drug in 3 study populations: obese children (2–18 years of age), normal weight children, and obese adults (aged >18 years). For each study population, we first reviewed a drug’s Food and Drug Administration label and then performed a systematic literature review. From the literature, we extracted drug PK data, biochemical properties, and dosing information. We then reviewed data in 3 age subpopulations (2–7 years, 8–12 years, and 13–18 years) for obese and normal weight children and by route of drug administration (intramuscular, intravenous, oral, and inhaled). If sufficient PK data were not available by age and route of administration, a data gap was identified. Findings Only 2 of 25 emergency care drugs (8%) contained dosing information on the Food and Drug Administration label for obese children and adults compared with 22 of 25 (88%) for normal weight children. We found no sufficient PK data in the literature for any of the emergency care drugs in obese children. Sufficient PK data were found for 7 of 25 emergency care drugs (28%) in normal weight children and 3 of 25 (12%) in obese adults. Implications Insufficient information exists to guide dosing in obese children for any of the emergency care drugs reviewed. This knowledge gap is alarming, given the known PK changes that occur in the setting of obesity. Future clinical trials examining the PK properties of emergency care medications in obese children should be prioritized.
doi_str_mv 10.1016/j.clinthera.2015.08.006
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This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emergency setting can limit therapeutic efficacy and increase drug-related toxic effects for obese children. Few systematic reviews examining PK properties and drug dosing in obese children have been performed. Methods We identified 25 emergency care drugs from the Strategic National Stockpile and Acute Care Supportive Drugs List and performed a systematic review for each drug in 3 study populations: obese children (2–18 years of age), normal weight children, and obese adults (aged &gt;18 years). For each study population, we first reviewed a drug’s Food and Drug Administration label and then performed a systematic literature review. From the literature, we extracted drug PK data, biochemical properties, and dosing information. We then reviewed data in 3 age subpopulations (2–7 years, 8–12 years, and 13–18 years) for obese and normal weight children and by route of drug administration (intramuscular, intravenous, oral, and inhaled). If sufficient PK data were not available by age and route of administration, a data gap was identified. Findings Only 2 of 25 emergency care drugs (8%) contained dosing information on the Food and Drug Administration label for obese children and adults compared with 22 of 25 (88%) for normal weight children. We found no sufficient PK data in the literature for any of the emergency care drugs in obese children. Sufficient PK data were found for 7 of 25 emergency care drugs (28%) in normal weight children and 3 of 25 (12%) in obese adults. Implications Insufficient information exists to guide dosing in obese children for any of the emergency care drugs reviewed. This knowledge gap is alarming, given the known PK changes that occur in the setting of obesity. Future clinical trials examining the PK properties of emergency care medications in obese children should be prioritized.</description><identifier>ISSN: 0149-2918</identifier><identifier>ISSN: 1879-114X</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2015.08.006</identifier><identifier>PMID: 26323523</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Child ; children ; Drug Administration Schedule ; Drug Dosage Calculations ; emergency care ; Emergency Medical Services - methods ; Humans ; Internal Medicine ; Medical Education ; obesity ; Pediatric Obesity - metabolism ; Pharmaceutical Preparations - administration &amp; dosage ; Pharmacokinetics ; United States ; United States Food and Drug Administration</subject><ispartof>Clinical therapeutics, 2015-09, Vol.37 (9), p.1924-1932</ispartof><rights>Elsevier HS Journals, Inc.</rights><rights>2015 Elsevier HS Journals, Inc.</rights><rights>Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c545t-c57f6c9a8c8e6872363e8fbd8bed7b169cd8f7e7a35049438ee8a6f356f471b93</citedby><cites>FETCH-LOGICAL-c545t-c57f6c9a8c8e6872363e8fbd8bed7b169cd8f7e7a35049438ee8a6f356f471b93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.clinthera.2015.08.006$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64387</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26323523$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rowe, Stevie, MD</creatorcontrib><creatorcontrib>Siegel, David, MD</creatorcontrib><creatorcontrib>Benjamin, Daniel K., MD, PhD, MPH</creatorcontrib><creatorcontrib>on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee</creatorcontrib><creatorcontrib>Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee</creatorcontrib><title>Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Abstract Purpose Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emergency setting can limit therapeutic efficacy and increase drug-related toxic effects for obese children. Few systematic reviews examining PK properties and drug dosing in obese children have been performed. Methods We identified 25 emergency care drugs from the Strategic National Stockpile and Acute Care Supportive Drugs List and performed a systematic review for each drug in 3 study populations: obese children (2–18 years of age), normal weight children, and obese adults (aged &gt;18 years). For each study population, we first reviewed a drug’s Food and Drug Administration label and then performed a systematic literature review. From the literature, we extracted drug PK data, biochemical properties, and dosing information. We then reviewed data in 3 age subpopulations (2–7 years, 8–12 years, and 13–18 years) for obese and normal weight children and by route of drug administration (intramuscular, intravenous, oral, and inhaled). If sufficient PK data were not available by age and route of administration, a data gap was identified. Findings Only 2 of 25 emergency care drugs (8%) contained dosing information on the Food and Drug Administration label for obese children and adults compared with 22 of 25 (88%) for normal weight children. We found no sufficient PK data in the literature for any of the emergency care drugs in obese children. Sufficient PK data were found for 7 of 25 emergency care drugs (28%) in normal weight children and 3 of 25 (12%) in obese adults. Implications Insufficient information exists to guide dosing in obese children for any of the emergency care drugs reviewed. This knowledge gap is alarming, given the known PK changes that occur in the setting of obesity. Future clinical trials examining the PK properties of emergency care medications in obese children should be prioritized.</description><subject>Child</subject><subject>children</subject><subject>Drug Administration Schedule</subject><subject>Drug Dosage Calculations</subject><subject>emergency care</subject><subject>Emergency Medical Services - methods</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Medical Education</subject><subject>obesity</subject><subject>Pediatric Obesity - metabolism</subject><subject>Pharmaceutical Preparations - administration &amp; dosage</subject><subject>Pharmacokinetics</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>0149-2918</issn><issn>1879-114X</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkcFu1DAQhi0EokvhFcBHLhs8cew4HJBWaSlIRUUUJG6W40y2XpJ4sRNQ3h5HW3rgxMVz-f5_5G8IeQUsAwbyzSGzvRunOwwmyxmIjKmMMfmIbECV1Rag-P6YbBgU1TavQJ2RZzEeGGO8EvlTcpZLnnOR8w0ZrswxUjfSizDv6YWPbtzTzgd602BEWt-5vg04vqU7ervECQczOUu_4C-Hv6nvaO2HwY_9Qj8HjDa4Blt6OWDY42gXWpuA9BO2zqaYH-Nz8qQzfcQX9_OcfHt_-bX-sL2-ufpY7663VhRiSm_ZSVsZZRVKVeZcclRd06rUXjYgK9uqrsTScMGKquAKURnZcSG7ooSm4ufk9an3GPzPGeOkBxct9r0Z0c9RQwkgiqSgSGh5Qm3wMQbs9DG4wYRFA9Ora33QD6716lozpZPrlHx5v2RuBmwfcn_lJmB3AjB9NQkLOlqXvCQfAe2kW-_-Y8m7fzpWLvnsf-CC8eDnMCaTGnTMNdO368nXi4NgwHIO_A_-n6mQ</recordid><startdate>20150901</startdate><enddate>20150901</enddate><creator>Rowe, Stevie, MD</creator><creator>Siegel, David, MD</creator><creator>Benjamin, Daniel K., MD, PhD, MPH</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20150901</creationdate><title>Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications</title><author>Rowe, Stevie, MD ; Siegel, David, MD ; Benjamin, Daniel K., MD, PhD, MPH</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c545t-c57f6c9a8c8e6872363e8fbd8bed7b169cd8f7e7a35049438ee8a6f356f471b93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Child</topic><topic>children</topic><topic>Drug Administration Schedule</topic><topic>Drug Dosage Calculations</topic><topic>emergency care</topic><topic>Emergency Medical Services - methods</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Medical Education</topic><topic>obesity</topic><topic>Pediatric Obesity - metabolism</topic><topic>Pharmaceutical Preparations - administration &amp; dosage</topic><topic>Pharmacokinetics</topic><topic>United States</topic><topic>United States Food and Drug Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rowe, Stevie, MD</creatorcontrib><creatorcontrib>Siegel, David, MD</creatorcontrib><creatorcontrib>Benjamin, Daniel K., MD, PhD, MPH</creatorcontrib><creatorcontrib>on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee</creatorcontrib><creatorcontrib>Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rowe, Stevie, MD</au><au>Siegel, David, MD</au><au>Benjamin, Daniel K., MD, PhD, MPH</au><aucorp>on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee</aucorp><aucorp>Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2015-09-01</date><risdate>2015</risdate><volume>37</volume><issue>9</issue><spage>1924</spage><epage>1932</epage><pages>1924-1932</pages><issn>0149-2918</issn><issn>1879-114X</issn><eissn>1879-114X</eissn><abstract>Abstract Purpose Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emergency setting can limit therapeutic efficacy and increase drug-related toxic effects for obese children. Few systematic reviews examining PK properties and drug dosing in obese children have been performed. Methods We identified 25 emergency care drugs from the Strategic National Stockpile and Acute Care Supportive Drugs List and performed a systematic review for each drug in 3 study populations: obese children (2–18 years of age), normal weight children, and obese adults (aged &gt;18 years). For each study population, we first reviewed a drug’s Food and Drug Administration label and then performed a systematic literature review. From the literature, we extracted drug PK data, biochemical properties, and dosing information. We then reviewed data in 3 age subpopulations (2–7 years, 8–12 years, and 13–18 years) for obese and normal weight children and by route of drug administration (intramuscular, intravenous, oral, and inhaled). If sufficient PK data were not available by age and route of administration, a data gap was identified. Findings Only 2 of 25 emergency care drugs (8%) contained dosing information on the Food and Drug Administration label for obese children and adults compared with 22 of 25 (88%) for normal weight children. We found no sufficient PK data in the literature for any of the emergency care drugs in obese children. Sufficient PK data were found for 7 of 25 emergency care drugs (28%) in normal weight children and 3 of 25 (12%) in obese adults. Implications Insufficient information exists to guide dosing in obese children for any of the emergency care drugs reviewed. This knowledge gap is alarming, given the known PK changes that occur in the setting of obesity. Future clinical trials examining the PK properties of emergency care medications in obese children should be prioritized.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26323523</pmid><doi>10.1016/j.clinthera.2015.08.006</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects Child
children
Drug Administration Schedule
Drug Dosage Calculations
emergency care
Emergency Medical Services - methods
Humans
Internal Medicine
Medical Education
obesity
Pediatric Obesity - metabolism
Pharmaceutical Preparations - administration & dosage
Pharmacokinetics
United States
United States Food and Drug Administration
title Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications
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