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Volumn 30, Issue 8, 2007, Pages 681-695

A modified prescription-event monitoring study to assess the introduction of Seretide Evohaler™ in England: An example of studying risk monitoring in pharmacovigilance

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; FLUTICASONE PROPIONATE PLUS SALMETEROL; NORFLURANE; SERETIDE EVOHALER; UNCLASSIFIED DRUG;

EID: 34548060344     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730080-00005     Document Type: Article
Times cited : (10)

References (42)
  • 1
    • 34548099021 scopus 로고    scopus 로고
    • The Montreal protocol on substances that deplete the ozone layer. 2000 [online]. Available from URL: http://www.une-p.org/ozone/Montreal-Protocol/ Montreal-Protocol2000.shtml [Accessed 2006 Aug 23]
    • The Montreal protocol on substances that deplete the ozone layer. 2000 [online]. Available from URL: http://www.une-p.org/ozone/Montreal-Protocol/ Montreal-Protocol2000.shtml [Accessed 2006 Aug 23]
  • 2
    • 28744449669 scopus 로고    scopus 로고
    • Hydrofluoroalkane as a propellant for pressurized metered-dose inhalers: History, pulmonary deposition, pharmacokinetics, efficacy and safety [in Portuguese]
    • Ibiapina CC, Cruz AA, Camargos PA. Hydrofluoroalkane as a propellant for pressurized metered-dose inhalers: history, pulmonary deposition, pharmacokinetics, efficacy and safety [in Portuguese]. J Pediatr (Rio J) 2004; 80 (6): 441-6
    • (2004) J Pediatr (Rio J) , vol.80 , Issue.6 , pp. 441-446
    • Ibiapina, C.C.1    Cruz, A.A.2    Camargos, P.A.3
  • 3
    • 33644621503 scopus 로고    scopus 로고
    • The CFC to HFA transition and its impact on pulmonary drug development
    • Leach CL. The CFC to HFA transition and its impact on pulmonary drug development. Respir Care 2005; 50 (9): 1201-8
    • (2005) Respir Care , vol.50 , Issue.9 , pp. 1201-1208
    • Leach, C.L.1
  • 4
    • 20444375060 scopus 로고    scopus 로고
    • Gates BJ, Neumiller JJ. CFC Phaseout and Adances in Oral Inhalers. Advances in Pharmacy 2005; 3 (2): 131-142, 155
    • Gates BJ, Neumiller JJ. CFC Phaseout and Adances in Oral Inhalers. Advances in Pharmacy 2005; 3 (2): 131-142, 155
  • 5
    • 1842608807 scopus 로고    scopus 로고
    • Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma
    • Zeidler M, Corren J. Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma. Treat Respir Med 2004; 3 (1): 35-44
    • (2004) Treat Respir Med , vol.3 , Issue.1 , pp. 35-44
    • Zeidler, M.1    Corren, J.2
  • 6
    • 34548094702 scopus 로고    scopus 로고
    • European Commission. European Community strategy for the phaseout of CFCs in metered dose inhalers, 1998 [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:51998DC0603:EN:HTML [Accessed 2006 Aug 23]
    • European Commission. European Community strategy for the phaseout of CFCs in metered dose inhalers, 1998 [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:51998DC0603:EN:HTML [Accessed 2006 Aug 23]
  • 7
    • 34548103372 scopus 로고    scopus 로고
    • European Agency for the Evaluation of Medicinal Products. Guideline for PMS studies for metered dose inhalers with new propellants. CPMP/180/95. 1995 [online]. Available from URL: http://www.emea.eu.int/pdfs/human/qwp/018095en.pdf [Accessed 2006 Sep 1]
    • European Agency for the Evaluation of Medicinal Products. Guideline for PMS studies for metered dose inhalers with new propellants. CPMP/180/95. 1995 [online]. Available from URL: http://www.emea.eu.int/pdfs/human/qwp/018095en.pdf [Accessed 2006 Sep 1]
  • 8
    • 34548095490 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Medicinal Products for Human Use. Pharmacovigilance planning E2E. 2004 [online, Available from URL:, Accessed 2006 Aug 23
    • International Conference on Harmonisation of Technical Requirements for Registration of Medicinal Products for Human Use. Pharmacovigilance planning E2E. 2004 [online]. Available from URL: http://www.ich.org [Accessed 2006 Aug 23]
  • 9
    • 84889411524 scopus 로고    scopus 로고
    • Prescription-event monitoring
    • Strom BL, editor, 4th ed. Chichester, UK: John Wiley & Sons Ltd
    • Shakir SAW. Prescription-event monitoring. In: Strom BL, editor. Pharmacoepidemiology. 4th ed. Chichester, UK: John Wiley & Sons Ltd, 2005: 203-16
    • (2005) Pharmacoepidemiology , pp. 203-216
    • Shakir, S.A.W.1
  • 14
    • 23844483910 scopus 로고    scopus 로고
    • Inhaled salmeterol/fluticasone propionate: A review of its use in asthma
    • Reynolds NA, Lyseng-Williamson KA, Wiseman LR. Inhaled salmeterol/fluticasone propionate: a review of its use in asthma. Drugs 2005; 65 (12): 1715-34
    • (2005) Drugs , vol.65 , Issue.12 , pp. 1715-1734
    • Reynolds, N.A.1    Lyseng-Williamson, K.A.2    Wiseman, L.R.3
  • 15
    • 0345700702 scopus 로고    scopus 로고
    • Adrenal crises in children treated with high-dose inhaled corticosteroids for asthma
    • Macdessi JS, Randell TL, Donaghue KC, et al. Adrenal crises in children treated with high-dose inhaled corticosteroids for asthma. Med J Aust 2003; 178 (5): 214-6
    • (2003) Med J Aust , vol.178 , Issue.5 , pp. 214-216
    • Macdessi, J.S.1    Randell, T.L.2    Donaghue, K.C.3
  • 16
    • 0036899187 scopus 로고    scopus 로고
    • Survey of adrenal crisis associated with inhaled corticosteroids in the United Kingdom
    • Todd GR, Acerini CL, Ross-Russell R, et al. Survey of adrenal crisis associated with inhaled corticosteroids in the United Kingdom. Arch Dis Child 2002; 87 (6): 457-61
    • (2002) Arch Dis Child , vol.87 , Issue.6 , pp. 457-461
    • Todd, G.R.1    Acerini, C.L.2    Ross-Russell, R.3
  • 17
    • 33144476873 scopus 로고    scopus 로고
    • The Salmeterol Multicenter Asthma Research Trial: A comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol
    • Nelson HS, Weiss ST, Bleecker ER, et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest 2006; 129 (1): 15-26
    • (2006) Chest , vol.129 , Issue.1 , pp. 15-26
    • Nelson, H.S.1    Weiss, S.T.2    Bleecker, E.R.3
  • 19
    • 0034940142 scopus 로고    scopus 로고
    • Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 microg twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma
    • Bateman ED, Silins V, Bogolubov M. Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 microg twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma. Respir Med 2001; 95 (2): 136-46
    • (2001) Respir Med , vol.95 , Issue.2 , pp. 136-146
    • Bateman, E.D.1    Silins, V.2    Bogolubov, M.3
  • 20
    • 0035060063 scopus 로고    scopus 로고
    • Clinical equivalence of a salmeterol/fluticasone proprionate combination product (50/500ug) delivered via a chlorofluorocarbon-free metered- dose inhaler with the Diskus™ in patients with moderate to severe asthma
    • van Noord JA, Lill T, Carillo Diaz T, et al. Clinical equivalence of a salmeterol/fluticasone proprionate combination product (50/500ug) delivered via a chlorofluorocarbon-free metered- dose inhaler with the Diskus™ in patients with moderate to severe asthma. Clin Drug Invest 2001; 21 (4): 243-56
    • (2001) Clin Drug Invest , vol.21 , Issue.4 , pp. 243-256
    • van Noord, J.A.1    Lill, T.2    Carillo Diaz, T.3
  • 21
    • 5344234072 scopus 로고    scopus 로고
    • Causality and correlation in pharmacovigilance
    • Talbot J, Waller P, editors, 5th ed. Chichester: John Wiley & Sons Ltd
    • Shakir SAW. Causality and correlation in pharmacovigilance. In: Talbot J, Waller P, editors. Stephens' detection of new adverse drug reactions. 5th ed. Chichester: John Wiley & Sons Ltd, 2003: 329-43
    • (2003) Stephens' detection of new adverse drug reactions , pp. 329-343
    • Shakir, S.A.W.1
  • 24
    • 0003542782 scopus 로고    scopus 로고
    • Confidentiality: Protecting and providing information
    • General Medical Council, London: General Medical Council
    • General Medical Council. Confidentiality: protecting and providing information. Frequently asked questions Q7. London: General Medical Council, 2004: 9
    • (2004) Frequently asked questions Q7 , pp. 9
  • 25
    • 0035651985 scopus 로고    scopus 로고
    • Prescription-event monitoring and reporting of adverse drug reactions
    • Heeley E, Riley J, Layton D, et al. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358: 1872-3
    • (2001) Lancet , vol.358 , pp. 1872-1873
    • Heeley, E.1    Riley, J.2    Layton, D.3
  • 26
    • 0032508249 scopus 로고    scopus 로고
    • Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice: Observational study
    • Martin RM, Kapoor KV, Wilton LV, et al. Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice: observational study. BMJ 1998; 317 (7151): 119-20
    • (1998) BMJ , vol.317 , Issue.7151 , pp. 119-120
    • Martin, R.M.1    Kapoor, K.V.2    Wilton, L.V.3
  • 27
    • 0031016668 scopus 로고    scopus 로고
    • Surveying general practitioners: Does a low response rate matter?
    • Templeton L, Deehan A, Taylor C, et al. Surveying general practitioners: does a low response rate matter? Br J General Pract 1997; 47: 91-4
    • (1997) Br J General Pract , vol.47 , pp. 91-94
    • Templeton, L.1    Deehan, A.2    Taylor, C.3
  • 28
    • 0033941220 scopus 로고    scopus 로고
    • Comparison of the seasonal patterns of asthma identified in general practitioner episodes, hospital admissions, and deaths
    • Fleming DM, Cross KW, Sunderland R, et al. Comparison of the seasonal patterns of asthma identified in general practitioner episodes, hospital admissions, and deaths. Thorax 2000; 55: 662-5
    • (2000) Thorax , vol.55 , pp. 662-665
    • Fleming, D.M.1    Cross, K.W.2    Sunderland, R.3
  • 29
    • 0036175787 scopus 로고    scopus 로고
    • Growth and adrenal suppression in asthmatic children on moderate to high doses of fluticasone propionate
    • Wong JY, Zacharin MR, Hocking N, et al. Growth and adrenal suppression in asthmatic children on moderate to high doses of fluticasone propionate. J Paediatr Child Health 2002; 38 (1): 59-62
    • (2002) J Paediatr Child Health , vol.38 , Issue.1 , pp. 59-62
    • Wong, J.Y.1    Zacharin, M.R.2    Hocking, N.3
  • 30
    • 0037383953 scopus 로고    scopus 로고
    • Adrenal suppression from high-dose inhaled fluticasone propionate in children with asthma
    • Sim D, Griffiths A, Armstrong D, et al. Adrenal suppression from high-dose inhaled fluticasone propionate in children with asthma. Eur Respir J 2003; 21 (4): 633-6
    • (2003) Eur Respir J , vol.21 , Issue.4 , pp. 633-636
    • Sim, D.1    Griffiths, A.2    Armstrong, D.3
  • 31
    • 4544353475 scopus 로고    scopus 로고
    • Visser MJ, van der Veer E, ma DS, et al. Side-effects of fluticasone in asthmatic children: no effects after dose reduction. Eur Respir J 2004; 24 (3): 420-5
    • Visser MJ, van der Veer E, ma DS, et al. Side-effects of fluticasone in asthmatic children: no effects after dose reduction. Eur Respir J 2004; 24 (3): 420-5
  • 33
    • 33644644745 scopus 로고    scopus 로고
    • Dry powder inhalers an overview
    • Atkins PJ. Dry powder inhalers an overview. Respir Care 2005; 50 (10): 1304-12
    • (2005) Respir Care , vol.50 , Issue.10 , pp. 1304-1312
    • Atkins, P.J.1
  • 34
    • 32844457856 scopus 로고    scopus 로고
    • Efficacy and tolerability of fluticasone propionate/salmeterol administered twice daily via hydrofluoroalkane 134a metered-dose inhaler in adolescent and adult patients with persistent asthma: A randomized, double-blind, placebo-controlled, 12-week study
    • Nathan RA, Rooklin A, Schoaf L, et al. Efficacy and tolerability of fluticasone propionate/salmeterol administered twice daily via hydrofluoroalkane 134a metered-dose inhaler in adolescent and adult patients with persistent asthma: a randomized, double-blind, placebo-controlled, 12-week study. Clin Ther 2006; 28 (1): 73-85
    • (2006) Clin Ther , vol.28 , Issue.1 , pp. 73-85
    • Nathan, R.A.1    Rooklin, A.2    Schoaf, L.3
  • 35
    • 0141656344 scopus 로고    scopus 로고
    • Efficacy and safety of fluticasone propionate 44 microg/salmeterol 21 microg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment
    • Nelson HS, Wolfe JD, Gross G, et al. Efficacy and safety of fluticasone propionate 44 microg/salmeterol 21 microg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment. Ann Allergy Asthma Immunol 2003; 91 (3): 263-9
    • (2003) Ann Allergy Asthma Immunol , vol.91 , Issue.3 , pp. 263-269
    • Nelson, H.S.1    Wolfe, J.D.2    Gross, G.3
  • 36
    • 19944394210 scopus 로고    scopus 로고
    • Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma
    • Pearlman DS, Peden D, Condemi JJ, et al. Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma. J Asthma 2004; 41 (8): 797-806
    • (2004) J Asthma , vol.41 , Issue.8 , pp. 797-806
    • Pearlman, D.S.1    Peden, D.2    Condemi, J.J.3
  • 37
    • 25444492853 scopus 로고    scopus 로고
    • Efficacy and safety of salmeterol/fluticasone propionate delivered via a hydrofluoroalkane metered dose inhaler in Chinese patients with moderate asthma poorly controlled with inhaled corticosteroids
    • You-Ning L, Humphries M, Du X, et al. Efficacy and safety of salmeterol/fluticasone propionate delivered via a hydrofluoroalkane metered dose inhaler in Chinese patients with moderate asthma poorly controlled with inhaled corticosteroids. Int J Clin Pract 2005; 59 (7): 754-9
    • (2005) Int J Clin Pract , vol.59 , Issue.7 , pp. 754-759
    • You-Ning, L.1    Humphries, M.2    Du, X.3
  • 38
    • 0032950216 scopus 로고    scopus 로고
    • The use of newly marketed drugs in children and adolescents prescribed in general practice
    • Wilton LV, Pearce G, Mann RD. The use of newly marketed drugs in children and adolescents prescribed in general practice. Pharmacoepidemiol Drug Saf 1999; 8 Suppl. 1: S37-45
    • (1999) Pharmacoepidemiol Drug Saf , vol.8 , Issue.SUPPL. 1
    • Wilton, L.V.1    Pearce, G.2    Mann, R.D.3
  • 39
    • 4544223810 scopus 로고    scopus 로고
    • The National Women's Health Study: Assembly and description of a population-based reproductive cohort
    • Maconochie N, Doyle P, Prior S. The National Women's Health Study: assembly and description of a population-based reproductive cohort. BMC Public Health 2004; 4: 35
    • (2004) BMC Public Health , vol.4 , pp. 35
    • Maconochie, N.1    Doyle, P.2    Prior, S.3
  • 41
    • 3042653098 scopus 로고    scopus 로고
    • CIOMS and ICH initiatives in pharmacovigilance and risk management: Overview and implications
    • Tsintis P, La ME. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications. Drug Saf 2004; 27 (8): 509-17
    • (2004) Drug Saf , vol.27 , Issue.8 , pp. 509-517
    • Tsintis, P.1    ME, L.2
  • 42
    • 0037275431 scopus 로고    scopus 로고
    • A model for the future conduct of pharmacovigilance
    • Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003; 12 (1): 17-29
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , Issue.1 , pp. 17-29
    • Waller, P.C.1    Evans, S.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.