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Volumn 70, Issue 4, 2014, Pages 445-452

The impact of legislation on drug substances used off-label in paediatric wards - A nationwide study

Author keywords

Children; Off label; Paediatric investigation plan; Paediatric regulation; Standard assortments

Indexed keywords

AMPHOTERICIN B; ANTIDEPRESSANT AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BETA LACTAM ANTIBIOTIC; CARBAPENEM DERIVATIVE; COLCHICINE; CONTRACEPTIVE AGENT; CORTICOSTEROID; CYCLOSPORIN A; ESOMEPRAZOLE; ESTRADIOL; GOLIMUMAB; HISTAMINE H2 RECEPTOR ANTAGONIST; HYDROCORTISONE; INFLIXIMAB; LEUPRORELIN; MACROLIDE; MELATONIN; MEROPENEM; METHYLPREDNISOLONE; METOPIMAZINE; OMEPRAZOLE; ORAL CONTRACEPTIVE AGENT; PARACETAMOL; PHENYLEPHRINE; POSACONAZOLE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TESTOSTERONE; TINZAPARIN;

EID: 84896489191     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-013-1626-1     Document Type: Article
Times cited : (14)

References (36)
  • 1
    • 84861808998 scopus 로고    scopus 로고
    • Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - A nationwide study
    • doi:10.1111/j.1651-2227.2012.02656.x
    • Kimland E, Nydert P, Odlind Vet al (2012) Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study. Acta Paediatr 101:772-778. doi:10.1111/j.1651-2227.2012.02656.x
    • (2012) Acta Paediatr , vol.101 , pp. 772-778
    • Kimland, E.1    Nydert, P.2    Odlind, V.3
  • 2
    • 33747495601 scopus 로고    scopus 로고
    • Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety
    • DOI 10.1517/14740338.5.5.703
    • Cuzzolin L, Atzei A, Fanos V (2006) Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf 5:703-718. doi:10.1517/14740338.5.5.703 (Pubitemid 44322888)
    • (2006) Expert Opinion on Drug Safety , vol.5 , Issue.5 , pp. 703-718
    • Cuzzolin, L.1    Atzei, A.2    Fanos, V.3
  • 3
    • 0036020410 scopus 로고    scopus 로고
    • Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands
    • doi:10.1007/s00228-002-0479-9
    • 't Jong GW, van der Linden PD, Bakker EM et al (2002) Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol 58:293 - 297. doi:10.1007/s00228-002-0479-9
    • (2002) Eur J Clin Pharmacol , vol.58 , pp. 293-297
    • 'T Jong, G.W.1    Van Der Linden, P.D.2    Bakker, E.M.3
  • 4
    • 65549126411 scopus 로고    scopus 로고
    • Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature
    • Lindell-Osuagwu L, KorhonenMJ, Saano S et al (2009) Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther 34:277-287
    • (2009) J Clin Pharm Ther , vol.34 , pp. 277-287
    • Lindell-Osuagwu, L.1    Korhonen, M.J.2    Saano, S.3
  • 6
    • 33845988069 scopus 로고    scopus 로고
    • An absence of pediatric randomized controlled trials in general medical journals, 1985-2004
    • DOI 10.1016/j.jclinepi.2006.03.015, PII S0895435606002885
    • Cohen E, Uleryk E, Jasuja M, Parkin PC (2007) An absence of pediatric randomized controlled trials in general medical journals, 1985-2004. J Clin Epidemiol 60:118-123. doi:10.1016/j.jclinepi.2006.03.015 (Pubitemid 46039874)
    • (2007) Journal of Clinical Epidemiology , vol.60 , Issue.2 , pp. 118-123
    • Cohen, E.1    Uleryk, E.2    Jasuja, M.3    Parkin, P.C.4
  • 7
    • 84896495311 scopus 로고    scopus 로고
    • EMA document Paediatric Regulation (EC) No 1901/2006. Accessed 4 Mar 2013
    • EMA document (2006) Official Journal of the European Union. Paediatric Regulation (EC) No 1901/2006. http://ec.europa.eu/health/files/eudralex/vol-1/ reg-2006-1901/reg-2006-1901-en.pdf. Accessed 4 Mar 2013
    • (2006) Official Journal of the European Union
  • 8
    • 79954447502 scopus 로고    scopus 로고
    • Three years of paediatric regulation in the European Union
    • doi:10.1007/s00228-011-0997-4
    • Olski TM, Lampus SF, Gherarducci G, Saint Raymond A (2011) Three years of paediatric regulation in the European Union. Eur J Clin Pharmacol 67:245 - 252. doi:10.1007/s00228-011-0997-4
    • (2011) Eur J Clin Pharmacol , vol.67 , pp. 245-252
    • Olski, T.M.1    Lampus, S.F.2    Gherarducci, G.3    Saint Raymond, A.4
  • 9
    • 79960950924 scopus 로고    scopus 로고
    • Framework conditions facilitating paediatric clinical research
    • doi:10.1186/1824-7288-37-12
    • Knellwolf A-L, Bauzon S, Alberighi ODC et al (2011) Framework conditions facilitating paediatric clinical research. Ital J Pediatr 37:12. doi:10.1186/1824-7288-37-12
    • (2011) Ital J Pediatr , vol.37 , pp. 12
    • Knellwolf, A.-L.1    Bauzon, S.2    Alberighi, O.D.C.3
  • 11
    • 84896490357 scopus 로고    scopus 로고
    • Data base Accessed 20 Nov 2012
    • Data base (2012) BIWeb. http://bihost.dk/amgros/login.aspx?ReturnUrl= %2famgros%2fdefault.aspx. Accessed 20 Nov 2012
    • (2012)
  • 12
    • 84896494972 scopus 로고    scopus 로고
    • Accessed 8 Mar 2013
    • WHOCC - ATC/DDD Index. http://www.whocc.no/atc-ddd-index/. Accessed 8 Mar 2013
    • WHOCC - ATC/DDD Index
  • 14
    • 4644224760 scopus 로고    scopus 로고
    • Danish Health and Medicine Authority Accessed Dec 2012
    • Danish Health and Medicine Authority (2012) Summary of product characteristics. http://www.produktresume.dk/docushare/dsweb/View/Collection-96. Accessed Dec 2012
    • (2012) Summary of Product Characteristics
  • 15
    • 84859930662 scopus 로고    scopus 로고
    • Off-label drug use in pediatric patients
    • doi:10.1038/clpt.2012.26
    • Kimland E, Odlind V (2012) Off-label drug use in pediatric patients. Clin Pharmacol Ther 91:796-801. doi:10.1038/clpt.2012.26
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 796-801
    • Kimland, E.1    Odlind, V.2
  • 16
    • 84896488263 scopus 로고    scopus 로고
    • WHO document Accessed 22 Feb 2013
    • WHO document (2013) WHOCC - Use of ATC/DDD. http://www.whocc.no/use-of- atc-ddd/. Accessed 22 Feb 2013
    • (2013) WHOCC - Use of ATC/DDD
  • 17
    • 84896491886 scopus 로고    scopus 로고
    • European Commission document Accessed 14 Oct 2013
    • European Commission document (2013) Better medicines for children from concept to reality. http://ec.europa.eu/health/files/paediatrics/2013-com443/ paediatric-report-com(2013)443-en.pdf. Accessed 14 Oct 2013
    • (2013) Better Medicines for Children from Concept to Reality
  • 18
    • 84857583598 scopus 로고    scopus 로고
    • Leuprolide acetate: Pharmaceutical use and delivery potentials
    • doi:10.1517/17425247.2012.662484
    • Teutonico D, Montanari S, Ponchel G (2012) Leuprolide acetate: pharmaceutical use and delivery potentials. Expert Opin Drug Deliv 9:343-354. doi:10.1517/17425247.2012.662484
    • (2012) Expert Opin Drug Deliv , vol.9 , pp. 343-354
    • Teutonico, D.1    Montanari, S.2    Ponchel, G.3
  • 19
    • 84878483008 scopus 로고    scopus 로고
    • Treatment and outcomes of precocious puberty: An update
    • doi:10.1210/jc.2013-1024
    • Fuqua JS (2013) Treatment and outcomes of precocious puberty: an update. J Clin Endocrinol Metab 98:2198-2207. doi:10.1210/jc.2013-1024
    • (2013) J Clin Endocrinol Metab , vol.98 , pp. 2198-2207
    • Fuqua, J.S.1
  • 20
    • 73849111592 scopus 로고    scopus 로고
    • Optimizing emetic control in children receiving antineoplastic therapy: Beyond the guidelines
    • doi:10.2165/11316190-000000000-00000
    • Dupuis LL, Nathan PC (2010) Optimizing emetic control in children receiving antineoplastic therapy: beyond the guidelines. Paediatr Drugs 12:51-61. doi:10.2165/11316190-000000000-00000
    • (2010) Paediatr Drugs , vol.12 , pp. 51-61
    • Dupuis, L.L.1    Nathan, P.C.2
  • 21
    • 32644479001 scopus 로고    scopus 로고
    • A pilot study of ondansetron plus metopimazine vs. ondansetron monotherapy in children receiving highly emetogenic chemotherapy: A Bayesian randomized serial N-of-1 trials design
    • DOI 10.1007/s00520-005-0875-7
    • Nathan PC, Tomlinson G, Dupuis LL et al (2006) A pilot study of ondansetron plus metopimazine vs. ondansetron monotherapy in children receiving highly emetogenic chemotherapy: a Bayesian randomized serial N-of-1 trials design. Support Care Cancer 14: 268-276. doi:10.1007/s00520-005-0875-7 (Pubitemid 43247931)
    • (2006) Supportive Care in Cancer , vol.14 , Issue.3 , pp. 268-276
    • Nathan, P.C.1    Tomlinson, G.2    Dupuis, L.L.3    Greenberg, M.L.4    Ota, S.5    Bartels, U.6    Feldman, B.M.7
  • 22
    • 84896495227 scopus 로고    scopus 로고
    • Accessed 15 Oct 2013
    • EuropeanMedicines Agency - EMEA-000265-PIP02-11 - Golimumab. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/pip-search. jsp&mid=WC0b01ac058001d129&source=homeMedSearch&keyword= golimumab&isNewQuery=true. Accessed 15 Oct 2013
    • EuropeanMedicines Agency - EMEA-000265-PIP02-11 - Golimumab
  • 23
    • 84896495534 scopus 로고    scopus 로고
    • Accessed 15 Oct 2013
    • European Medicines Agency - EMEA-000265-PIP01-08-M02 - Golimumab. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/pip-search. jsp&mid=WC0b01ac058001d129&source=homeMedSearch&keyword= golimumab&isNewQuery=true. Accessed 15 Oct 2013
    • European Medicines Agency - EMEA-000265-PIP01-08-M02 - Golimumab
  • 24
    • 84896490467 scopus 로고    scopus 로고
    • Off-label use and adverse events of biologic agents in paediatric patients with juvenile idiopathic arthritis
    • Broe J, Platz MA, Nielsen S et al (2013) Off-label use and adverse events of biologic agents in paediatric patients with juvenile idiopathic arthritis. Clin Ther 35:1-2 suppl
    • (2013) Clin Ther , vol.35 , Issue.SUPPL. , pp. 1-2
    • Broe, J.1    Platz, M.A.2    Nielsen, S.3
  • 25
    • 84880262056 scopus 로고    scopus 로고
    • New antibiotics for paediatric use: A review of a decade of regulatory trials submitted to the European Medicines Agency from 2000-why aren't we doing better?
    • doi:10.1016/j.ijantimicag.2013.05.001
    • Garazzino S, Lutsar I, Bertaina C et al (2013) New antibiotics for paediatric use: a review of a decade of regulatory trials submitted to the European Medicines Agency from 2000-why aren't we doing better? Int J Antimicrob Agents 42:99 - 118. doi:10.1016/j.ijantimicag.2013.05.001
    • (2013) Int J Antimicrob Agents , vol.42 , pp. 99-118
    • Garazzino, S.1    Lutsar, I.2    Bertaina, C.3
  • 26
    • 79951610193 scopus 로고    scopus 로고
    • Towards evidence-based pharmacotherapy in children
    • doi:10.1111/j.1460-9592.2010.03493.x
    • Kemper EM, Merkus M, Wierenga PC et al (2011) Towards evidence-based pharmacotherapy in children. Paediatr Anaesth 21: 183-189. doi:10.1111/j.1460- 9592.2010.03493.x
    • (2011) Paediatr Anaesth , vol.21 , pp. 183-189
    • Kemper, E.M.1    Merkus, M.2    Wierenga, P.C.3
  • 27
    • 34147193118 scopus 로고    scopus 로고
    • Infliximab and etanercept in the treatment of chronic uveitis associated with refractory juvenile idiopathic arthritis
    • DOI 10.1136/ard.2006.058248
    • Tynjälä P, Lindahl P, Honkanen V et al (2007) Infliximab and etanercept in the treatment of chronic uveitis associated with refractory juvenile idiopathic arthritis. Ann Rheum Dis 66:548-550. doi:10.1136/ard.2006. 058248 (Pubitemid 46580481)
    • (2007) Annals of the Rheumatic Diseases , vol.66 , Issue.4 , pp. 548-550
    • Tynjala, P.1    Lindahl, P.2    Honkanen, V.3    Lahdenne, P.4    Kotaniemi, K.5
  • 29
    • 84879297441 scopus 로고    scopus 로고
    • EuropeanMedicines Agency with its Paediatric Committee Accessed 19 Feb 2013
    • EuropeanMedicines Agency with its Paediatric Committee (2012) 5-year Report to the European Commission. http://ec.europa.eu/health/files/paediatrics/ 2012-09-pediatric-report-annex1-2-en.pdf. Accessed 19 Feb 2013
    • (2012) 5-year Report to the European Commission
  • 30
    • 84896490835 scopus 로고    scopus 로고
    • Accessed 19 Jun 2013
    • EMA document (2013) Successes of the paediatric regulation after 5 years. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2013/06/ news-detail-001823.jsp&mid=WC0b01ac058004d5c1. Accessed 19 Jun 2013
    • (2013) Successes of the Paediatric Regulation after 5 Years
  • 32
    • 84952672761 scopus 로고    scopus 로고
    • EMA document Paediatric Medicines Section Accessed 2 Oct 2013
    • EMA document Paediatric Medicines Section (2013) Report to the European Commission. http://ec.europa.eu/health/human-use/paediatric-medicines/ developments/. Accessed 2 Oct 2013
    • (2013) Report to the European Commission
  • 33
  • 34
    • 79956308263 scopus 로고    scopus 로고
    • The pharmacokinetics of intravenous paracetamol in neonates: Size matters most
    • doi:10.1136/adc.2010.204552
    • Allegaert K, Palmer GM, Anderson BJ (2011) The pharmacokinetics of intravenous paracetamol in neonates: size matters most. Arch Dis Child 96:575 - 580. doi:10.1136/adc.2010.204552
    • (2011) Arch Dis Child , vol.96 , pp. 575-580
    • Allegaert, K.1    Palmer, G.M.2    Anderson, B.J.3
  • 35
    • 84896490337 scopus 로고    scopus 로고
    • Accessed 11 Oct 2013
    • European Medicines Agency - EMEA-000898-PIP01-10 -Meropenem. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/pips/ EMEA-000898-PIP01-10/pip-000668.jsp&mid=WC0b01ac058001d129&source= homeMedSearch. Accessed 11 Oct 2013
    • European Medicines Agency - EMEA-000898-PIP01-10 -Meropenem.
  • 36
    • 77955741814 scopus 로고    scopus 로고
    • Pain management in the paediatric population: The regulatory situation in Europe
    • doi:10.1136/adc.2009.179549
    • Fortinguerra F, Maschi S, Clavenna A, Bonati M (2010) Pain management in the paediatric population: the regulatory situation in Europe. Arch Dis Child 95:749 -753. doi:10.1136/adc.2009.179549
    • (2010) Arch Dis Child , vol.95 , pp. 749-753
    • Fortinguerra, F.1    Maschi, S.2    Clavenna, A.3    Bonati, M.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.