Off label and unlicensed drug use among French office based paediatricians
AIMS To determine the extent of off label and unlicensed drug use in French office based paediatric practice. METHODS A prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome meas...
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| Veröffentlicht in: | Archives of disease in childhood 2000-12, Vol.83 (6), p.502-505 |
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| creator | Chalumeau, M Tréluyer, J M Salanave, B Assathiany, R Chéron, G Crocheton, N Rougeron, C Mares, M Bréart, G Pons, G |
| description | AIMS To determine the extent of off label and unlicensed drug use in French office based paediatric practice. METHODS A prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration. RESULTS A total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions. CONCLUSIONS Off label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group. |
| doi_str_mv | 10.1136/adc.83.6.502 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_1718582</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4009012721</sourcerecordid><originalsourceid>FETCH-LOGICAL-b506t-4dfe6c1e244898d750c5aab1886683cfad6664852b939620032cc4b9dbc700513</originalsourceid><addsrcrecordid>eNp9kU2P0zAQhi0EYsvCjTOKhAQXUvwVZ3JZCRWWDy0sQgscrYntdF0Sp9gJgn-Pq1Zl4cBpDvPonXf0EPKQ0SVjQj1Ha5YglmpZUX6LLJhUUHIq5W2yoJSKsgGAE3IvpQ2ljAOIu-SEMQo1B7Ug7y67ruixdX2BwRZz6L1xITlb2Divizm5AocxrIvz6IK5Lsauy0DR4g7ZorMep-iNx5Dukzsd9sk9OMxT8vn81dXqTXlx-frt6sVF2VZUTaW0nVOGOS4lNGDripoKsWUASoEwHVqllISKt41oFM8vcGNk29jW1JRWTJySs33udm4HZ3PdKWKvt9EPGH_pEb3-exP8tV6PPzSrGVTAc8CTQ0Acv88uTXrwybi-x-DGOemaSy4qRTP4-B9wM84x5OdyVg20ltlApp7tKRPHlKLrjlUY1TtFOivSILTSWVHGH92s_wc-OLlxFZPBvosYjE9HDjhnrMpUuad8mtzP4xbjN61qUVf6w5eV_vTxZUO_vr_Su7NP93w7bP5f8Df-2bPh</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1778074113</pqid></control><display><type>article</type><title>Off label and unlicensed drug use among French office based paediatricians</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Chalumeau, M ; Tréluyer, J M ; Salanave, B ; Assathiany, R ; Chéron, G ; Crocheton, N ; Rougeron, C ; Mares, M ; Bréart, G ; Pons, G</creator><creatorcontrib>Chalumeau, M ; Tréluyer, J M ; Salanave, B ; Assathiany, R ; Chéron, G ; Crocheton, N ; Rougeron, C ; Mares, M ; Bréart, G ; Pons, G</creatorcontrib><description>AIMS To determine the extent of off label and unlicensed drug use in French office based paediatric practice. METHODS A prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration. RESULTS A total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions. CONCLUSIONS Off label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group.</description><identifier>ISSN: 0003-9888</identifier><identifier>EISSN: 1468-2044</identifier><identifier>DOI: 10.1136/adc.83.6.502</identifier><identifier>PMID: 11087286</identifier><identifier>CODEN: ADCHAK</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</publisher><subject>Adolescent ; Adolescents ; approval ; Biological and medical sciences ; Child ; Child, Preschool ; drug ; Drug Approval ; Drug Labeling ; Drug Prescriptions - statistics & numerical data ; Drug Therapy - statistics & numerical data ; Drug use ; Drug Utilization ; France ; General and Specialist Paediatrics ; Hospitals ; Humans ; Infant ; Infant, Newborn ; Medical Education ; Medical sciences ; Metropolitan areas ; Miscellaneous ; Narcotics ; Neonates ; office visit ; Office Visits ; Patients ; Pharmaceutical industry ; Physicians ; Prescription drugs ; Prevention and actions ; Primary Health Care - statistics & numerical data ; prospective ; Prospective Studies ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; study ; utilisation ; Worksheets ; Young Children</subject><ispartof>Archives of disease in childhood, 2000-12, Vol.83 (6), p.502-505</ispartof><rights>Royal College of Paediatrics and Child Health</rights><rights>2001 INIST-CNRS</rights><rights>Copyright: 2000 Royal College of Paediatrics and Child Health</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b506t-4dfe6c1e244898d750c5aab1886683cfad6664852b939620032cc4b9dbc700513</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1718582/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1718582/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=822115$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11087286$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chalumeau, M</creatorcontrib><creatorcontrib>Tréluyer, J M</creatorcontrib><creatorcontrib>Salanave, B</creatorcontrib><creatorcontrib>Assathiany, R</creatorcontrib><creatorcontrib>Chéron, G</creatorcontrib><creatorcontrib>Crocheton, N</creatorcontrib><creatorcontrib>Rougeron, C</creatorcontrib><creatorcontrib>Mares, M</creatorcontrib><creatorcontrib>Bréart, G</creatorcontrib><creatorcontrib>Pons, G</creatorcontrib><title>Off label and unlicensed drug use among French office based paediatricians</title><title>Archives of disease in childhood</title><addtitle>Arch Dis Child</addtitle><description>AIMS To determine the extent of off label and unlicensed drug use in French office based paediatric practice. METHODS A prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration. RESULTS A total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions. CONCLUSIONS Off label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group.</description><subject>Adolescent</subject><subject>Adolescents</subject><subject>approval</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>drug</subject><subject>Drug Approval</subject><subject>Drug Labeling</subject><subject>Drug Prescriptions - statistics & numerical data</subject><subject>Drug Therapy - statistics & numerical data</subject><subject>Drug use</subject><subject>Drug Utilization</subject><subject>France</subject><subject>General and Specialist Paediatrics</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Medical Education</subject><subject>Medical sciences</subject><subject>Metropolitan areas</subject><subject>Miscellaneous</subject><subject>Narcotics</subject><subject>Neonates</subject><subject>office visit</subject><subject>Office Visits</subject><subject>Patients</subject><subject>Pharmaceutical industry</subject><subject>Physicians</subject><subject>Prescription drugs</subject><subject>Prevention and actions</subject><subject>Primary Health Care - statistics & numerical data</subject><subject>prospective</subject><subject>Prospective Studies</subject><subject>Public health. 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METHODS A prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration. RESULTS A total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions. CONCLUSIONS Off label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health</pub><pmid>11087286</pmid><doi>10.1136/adc.83.6.502</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adolescents approval Biological and medical sciences Child Child, Preschool drug Drug Approval Drug Labeling Drug Prescriptions - statistics & numerical data Drug Therapy - statistics & numerical data Drug use Drug Utilization France General and Specialist Paediatrics Hospitals Humans Infant Infant, Newborn Medical Education Medical sciences Metropolitan areas Miscellaneous Narcotics Neonates office visit Office Visits Patients Pharmaceutical industry Physicians Prescription drugs Prevention and actions Primary Health Care - statistics & numerical data prospective Prospective Studies Public health. Hygiene Public health. Hygiene-occupational medicine study utilisation Worksheets Young Children |
| title | Off label and unlicensed drug use among French office based paediatricians |
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