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Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA (2013)

  • Authors:
  • USP affiliated authors: CAMPOS, MARILIA SILVEIRA DE ALMEIDA - FCFRP ; PEREIRA, LEONARDO RÉGIS LEIRA - FCFRP
  • USP Schools: FCFRP; FCFRP
  • DOI: 10.1007/s11096-013-9755-2
  • Subjects: SAÚDE; VIGILÂNCIA (FARMACOLOGIA); CRIANÇAS; ALIMENTOS; MEDICAMENTO (ADMINISTRAÇÃO)
  • Language: Inglês
  • Imprenta:
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    Informações sobre o DOI: 10.1007/s11096-013-9755-2 (Fonte: oaDOI API)
    • Este periódico é de assinatura
    • Este artigo NÃO é de acesso aberto
    • Cor do Acesso Aberto: closed
    Informações sobre o Citescore
  • Título: International Journal of Clinical Pharmacy

    ISSN: 2210-7703

    Citescore - 2017: 1.58

    SJR - 2017: 0.702

    SNIP - 2017: 0.857


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    • ABNT

      BORGES, Anna Paula de Sá; CAMPOS, Marília Silveira de Almeida; PEREIRA, Leonardo Régis Leira. Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA. International Journal of Clinical Pharmacy, Dordrecht, v. 35, n. 3, p. 425-431, 2013. Disponível em: < http://dx.doi.org/10.1007/s11096-013-9755-2 > DOI: 10.1007/s11096-013-9755-2.
    • APA

      Borges, A. P. de S., Campos, M. S. de A., & Pereira, L. R. L. (2013). Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA. International Journal of Clinical Pharmacy, 35( 3), 425-431. doi:10.1007/s11096-013-9755-2
    • NLM

      Borges AP de S, Campos MS de A, Pereira LRL. Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA [Internet]. International Journal of Clinical Pharmacy. 2013 ; 35( 3): 425-431.Available from: http://dx.doi.org/10.1007/s11096-013-9755-2
    • Vancouver

      Borges AP de S, Campos MS de A, Pereira LRL. Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA [Internet]. International Journal of Clinical Pharmacy. 2013 ; 35( 3): 425-431.Available from: http://dx.doi.org/10.1007/s11096-013-9755-2

    Referências citadas na obra
    Hoppu K. Paediatric clinical pharmacology—at the beginning of a new era. Eur J Clin Pharmacol. 2008;64:201–5.
    World Health Organization. Promoting safety of medicines for children. Geneva: WHO; 2007. ISBN 978-92-4-156343-7.
    Wilson JT. An update on the therapeutic orphan. Pediatrics. 1999;104:585–90.
    Choonara I, Conroy S. Unlicensed and off-label drug use in children—implications for safety. Drug Saf. 2002;25:1–5.
    Conroy S. Unlicensed and off-label drug use—issues and recommendations. Paediatr Drugs. 2002;4:353–9.
    Hanssens Y, Deleu D, Al Balushi K, Al Hashar A, Al-Zakwani I. Drug utilization pattern of anti-epileptic drugs: a pharmacoepidemiologic study in Oman. J Clin Pharm Ther. 2002;27:357–64.
    Koshy S. Role of pharmacists in the management of patients with epilepsy. Int J Pharm Pract. 2012;20:65–8.
    Kimland E, Nydert P, Odlind V, Böttiger Y, Lindemalm S. Pediatric drug use with focus on off-label prescriptions at Swedish hospital—a nationwide study. Acta Paediatr. 2012;101:1–7.
    Morales-Carpi C, Estañ L, Rubio E, Lurbe E, Morales-Olivas FJ. Drug utilization and off-label drug use among Spanish emergency room pediatric patients. Eur J Clin Pharmacol. 2010;66:315–20.
    Clarkson A, Choonara I. Surveillance for fatal suspected adverse drug reaction in the UK. Arch Dis Child. 2002;87:462–7.
    Friedman DOMJ, Sharieff MDGQ. Seizures in children. Pediatr Clin N Am. 2006;53:257–77.
    Chen LC, Chen YF, Yang LL, Chou MH, Lin MF. Drug utilization pattern of antiepileptic drugs and traditional Chinese medicines in a general hospital in Taiwan—a pharmaco-epidemiologic study. J Clin Pharm Ther. 2000;25:125–9.
    Food and Drug Administration. Guidance for industry: E11 clinical investigation of medicinal products in the pediatric population. Rockille, Md. 2000. Available: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129477.pdf . Accessed 30 Aug 2012.
    Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off label drug use in paediatric wards: prospective study. BMJ. 1998;316:343–5.
    Abasolo-Osinaga E, Abecia-Inchaurregui LC, Etxeandia-Ikobaltzeta I, Burgos-Alonso N, Pozo JG. Estudio farmacoepidemiológico del consumo de fármacos antiepilépticos (1992–2004). Rev Neurol. 2008;46:449–53.
    Chen AH. Update on pediatric epilepsy. Adv Pediatr. 2011;58:259–76.
    Hasan SS, Bahari MB, Bazar ZU, Ganesan V. Antiepileptic drug utilization and seizure outcome among pediatric patients in a Malaysian public hospital. Singap Med J. 2010;51:21–7.
    Deckers CLP, Hekstert YA, Keyser A, Meinardi H, Reiner WO. Pharmacotherapy of epilepsy: state of the art and developments. J Clin Pharm Ther. 1997;22:309–22.
    Ministério da Saúde (Brazil). PORTARIA SAS/MS No 492, de 23 de setembro de 2010. Protocolo Clínico e Diretrizes Terapêuticas—Epilepsia. [Brazilian Therapeutic Guideline—Epilepsy]. Available: http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_epilepsia_.pdf . Accessed 05 April 2012.
    Glauser T, Ben-Menachem E, Borgeous B, Cnaan A, Chadwick D, Guerreiro C, et al. ILAE treatment guidelines: evidence-based analysis of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2006;47:1094–120.
    Abend NS, Gutierrez-Colina AM, Dlugos DJ. Medical treatment of pediatric status epileptics. Semin Pediatr Neurol. 2010;17:169–75.
    Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342(5):314–9.
    Nicholas JM, Ridsdale L, Richardson MP, Ashworth M, Gulliford MC. Trends in antiepileptic drug utilisation in UK primary care 1993–2008: cohort study using the general practice research database. Seizure. 2012;21(6):466–70.
    Perucca E. Clinically relevant drug interaction with antiepileptic drugs. Br J Clin Pharmacol. 2005;61:246–55.
    Johannessen SI, Landmark CJ. Antiepileptic drug interactions—principles and clinical implications. Curr Neuropharmacol. 2010;8:254–67.
    Yi ZM, Zhai SD, Huang S, Wang TS, Liu F. Off-label prescriptions for adult neurological patients: a pilot survey in China. Int J Clin Pharm. 2012;34(1):81–7.
    Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off-label drug use in paediatric wards in European countries. BMJ. 2000;7227(320):79–82.
    Shah SS, Goodman D, Feur P, Sharma V, Fargason C Jr, Hyman D, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007;161:282–90.
    Dell’Aera M, Gasbarro AR, Padovano M, Laforgia N, Capodiferro D, Solarino B, et al. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci. 2007;29(4):361–7.
    Di Paolo ER, Stoetter H, Cotting J, Frey P, Gehri M, Beck-Popovic M, et al. Unlicensed and off-label drug use in a Swiss pediatric university hospital. Swiss Med Wkly. 2006;136:218–22.
    ‘t Jong GW, van der Linden PD, Bakker EM, van der Lely N, Eland IA, Stricker BH, van den Anker JN. Unlicensed and off-label use in a pediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol. 2002;58:293–7.
    Schirm E, Tobi H, Berg LTWJ. Risk factor for unlicensed and off-label drug use in children outside the hospital. Pediatrics. 2003;111:291–5.
    Agência Nacional de Vigilância Sanitária (Brazil). Medicamentos. [Brazilian National Health Surveillance Agency. Drugs]. Available: http://portal.anvisa.gov.br/wps/content/Anvisa+Portal/Anvisa/Inicio/Medicamentos . Accessed 20 Feb 2011.