Unapproved and Off-Label Use of Drugs in a Children's Hospital
To the Editor: Treatment of children may be difficult because of a shortage of properly formulated or approved drugs. 1 In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). W...
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Veröffentlicht in: | The New England journal of medicine 2000-10, Vol.343 (15), p.1125-1125 |
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container_title | The New England journal of medicine |
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creator | `t Jong, Geert W Vulto, Arnold G de Hoog, Matthijs Schimmel, Kirsten J.M Tibboel, Dick van den Anker, John N |
description | To the Editor:
Treatment of children may be difficult because of a shortage of properly formulated or approved drugs.
1
In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). We studied the unapproved and off-label use of drugs in a children's hospital in which the hospital pharmacy, unlike pharmacies in many other European countries, is allowed to prepare “homemade” formulations and to modify commercial preparations in order to suit the needs of children.
During a five-week period, we classified the use . . . |
doi_str_mv | 10.1056/NEJM200010123431515 |
format | Article |
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Treatment of children may be difficult because of a shortage of properly formulated or approved drugs.
1
In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). We studied the unapproved and off-label use of drugs in a children's hospital in which the hospital pharmacy, unlike pharmacies in many other European countries, is allowed to prepare “homemade” formulations and to modify commercial preparations in order to suit the needs of children.
During a five-week period, we classified the use . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJM200010123431515</identifier><identifier>PMID: 11032528</identifier><identifier>CODEN: NEJMAG</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>Adolescent ; Child ; Child, Preschool ; Drug Approval ; Drug Labeling ; Drug Prescriptions - statistics & numerical data ; Drug Utilization Review ; Formularies, Hospital ; Hospitals, Pediatric - statistics & numerical data ; Humans ; Infant ; Infant, Newborn ; Netherlands</subject><ispartof>The New England journal of medicine, 2000-10, Vol.343 (15), p.1125-1125</ispartof><rights>Copyright © 2000 Massachusetts Medical Society. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-5cb55105f1bbc1282445d9ec283a90a33a7b6e459d0b755ad2def5872482e4183</citedby><cites>FETCH-LOGICAL-c448t-5cb55105f1bbc1282445d9ec283a90a33a7b6e459d0b755ad2def5872482e4183</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.nejm.org/doi/pdf/10.1056/NEJM200010123431515$$EPDF$$P50$$Gmms$$H</linktopdf><linktohtml>$$Uhttps://www.nejm.org/doi/full/10.1056/NEJM200010123431515$$EHTML$$P50$$Gmms$$H</linktohtml><link.rule.ids>314,776,780,2746,2747,26080,27901,27902,52357,54039</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11032528$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>`t Jong, Geert W</creatorcontrib><creatorcontrib>Vulto, Arnold G</creatorcontrib><creatorcontrib>de Hoog, Matthijs</creatorcontrib><creatorcontrib>Schimmel, Kirsten J.M</creatorcontrib><creatorcontrib>Tibboel, Dick</creatorcontrib><creatorcontrib>van den Anker, John N</creatorcontrib><title>Unapproved and Off-Label Use of Drugs in a Children's Hospital</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>To the Editor:
Treatment of children may be difficult because of a shortage of properly formulated or approved drugs.
1
In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). We studied the unapproved and off-label use of drugs in a children's hospital in which the hospital pharmacy, unlike pharmacies in many other European countries, is allowed to prepare “homemade” formulations and to modify commercial preparations in order to suit the needs of children.
During a five-week period, we classified the use . . .</description><subject>Adolescent</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Drug Approval</subject><subject>Drug Labeling</subject><subject>Drug Prescriptions - statistics & numerical data</subject><subject>Drug Utilization Review</subject><subject>Formularies, Hospital</subject><subject>Hospitals, Pediatric - statistics & numerical data</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Netherlands</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2000</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kEtLAzEYRYMotlZ_gSDBhS5kNPmSzCQbQWp9Ue3GrkNmktEp86hJR_Dfm9KCIOLqbs69HC5Cx5RcUiLSq5fJ0zMQQiihwDijgoodNKSCsYRzku6iISEgE54pNkAHISzIGuZqHw0oJQwEyCG6nrdmufTdp7PYtBbPyjKZmtzVeB4c7kp86_u3gKsWGzx-r2rrXXse8EMXltXK1IdorzR1cEfbHKH53eR1_JBMZ_eP45tpUnAuV4kociGidEnzvKAggXNhlStAMqOIYcxkeeq4UJbkmRDGgnWlkBlwCY5TyUbobLMbVT96F1a6qULh6tq0ruuDzgBUqoBE8PQXuOh630Y3DcBUtGBZhNgGKnwXgnelXvqqMf5LU6LX3-o_vo2tk-10nzfO_nS2Z0bgYgM0TdCtWzT_zn0Ddud8yA</recordid><startdate>20001012</startdate><enddate>20001012</enddate><creator>`t Jong, Geert W</creator><creator>Vulto, Arnold G</creator><creator>de Hoog, Matthijs</creator><creator>Schimmel, Kirsten J.M</creator><creator>Tibboel, Dick</creator><creator>van den Anker, John N</creator><general>Massachusetts Medical Society</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>0TZ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K0Y</scope><scope>LK8</scope><scope>M0R</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20001012</creationdate><title>Unapproved and Off-Label Use of Drugs in a Children's Hospital</title><author>`t Jong, Geert W ; 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Treatment of children may be difficult because of a shortage of properly formulated or approved drugs.
1
In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). We studied the unapproved and off-label use of drugs in a children's hospital in which the hospital pharmacy, unlike pharmacies in many other European countries, is allowed to prepare “homemade” formulations and to modify commercial preparations in order to suit the needs of children.
During a five-week period, we classified the use . . .</abstract><cop>United States</cop><pub>Massachusetts Medical Society</pub><pmid>11032528</pmid><doi>10.1056/NEJM200010123431515</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine |
subjects | Adolescent Child Child, Preschool Drug Approval Drug Labeling Drug Prescriptions - statistics & numerical data Drug Utilization Review Formularies, Hospital Hospitals, Pediatric - statistics & numerical data Humans Infant Infant, Newborn Netherlands |
title | Unapproved and Off-Label Use of Drugs in a Children's Hospital |
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