A modified prescription-event monitoring study to assess the introduction of Flixotide Evohaler™ into general practice in England: An example of pharmacovigilance planning and risk monitoring

Pharmacoepidemiology and Drug Safety

Volumn 16, Issue 9, 2007, Pages 969-978

  Perrio, Michael J ^a   Wilton, Lynda V ^a,b  

^a DRUG SAFETY RESEARCH UNIT   (United Kingdom)

^b UNIVERSITY OF PORTSMOUTH   (United Kingdom)

Author keywords

Asthma; Chronic obstructive pulmonary disease; Fluticasone; Modified PEM; Pharmacovigilance; Pregnancy; Prescription event monitoring; Risk management

Indexed keywords

FLUTICASONE PROPIONATE; STEROID;

ADOLESCENT; ADULT; AGED; ALLERGIC REACTION; ANGIONEUROTIC EDEMA; ARTICLE; ASTHMA; BACKACHE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; DISEASE EXACERBATION; DISEASE SEVERITY; DISORIENTATION; DRUG ERUPTION; DRUG MONITORING; DRUG SUBSTITUTION; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; ECZEMA; FACE EDEMA; FEMALE; FLUSHING; GENERAL PRACTICE; HALLUCINATION; HEART ATRIUM FIBRILLATION; HEART FAILURE; HEART PALPITATION; HOARSENESS; HUMAN; HYPERACTIVITY; LARYNGITIS; LIVER FUNCTION TEST; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; MOUTH PAIN; MYALGIA; NAUSEA AND VOMITING; OFF LABEL DRUG USE; OSTEOARTHRITIS; OTITIS MEDIA; PHARYNGITIS; PREGNANCY; PRENATAL DRUG EXPOSURE; PRESCRIPTION; PRIORITY JOURNAL; QUESTIONNAIRE; RISK MANAGEMENT; SIDE EFFECT; UNITED KINGDOM; UPPER RESPIRATORY TRACT INFECTION; VOICE CHANGE; VOMITING; WHEEZING;

ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; ANDROSTADIENES; ASTHMA; BRONCHODILATOR AGENTS; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; ENGLAND; FAMILY PRACTICE; FEMALE; HUMANS; INFANT, NEWBORN; MALE; METERED DOSE INHALERS; MIDDLE AGED; PREGNANCY; QUESTIONNAIRES; RISK FACTORS; TIME FACTORS;

EID: 34548751268     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1411     Document Type: Article

References (37)

1. The Montreal protocol on substances that deplete the ozone layer, 2000. http://www.unep.org/ozone/Montreal-Protocol/ Montreal-Protocol2000.shtml [last accessed 23/08/2006].
2. Ibiapina CC, Cruz AA, Camargos PA. Hydrofluoroalkane as a propellant for pressurized metered-dose inhalers: history, pulmonary deposition, pharmacokinetics, efficacy and safety. J Pediatr (Rio J) 2004; 80(6): 441-446.
3. Leach CL. The CFC to HFA transition and its impact on pulmonary drug development. Respir Care 2005; 50(9): 1201-1208.
4. Gates BJ, Neumiller JJ. CFC phaseout and advances in oral inhalers. Advances in Pharmacy 2005; 3(2): 131-142, 155.
5. Zeidler M, Corren J. Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma. Treat Respir Med 2004; 3(1): 35-44.
6. European Commission. European Community Strategy for the Phaseout of CFCs in Metered Dose Inhalers, 1998. http://eurlex.europa.eu/ LexUriServ/LexUriServ.do?.uri=CELEX:51998DC0603:EN:HTML [last accessed 23/08/2006].
7. European Agency for the Evaluation of Medicinal Products. Guideline for PMS studies for metered dose inhalers with new propellants. CPMP/180/ 95, 1995. www.emea.eu.int/pdfs/human/qwp/018095en.pdf [last accessed 01/09/2006].
8. Allen & Hanburys. Flixotide Evohaler, Summary of product characteristics, 2000.
9. Macdessi JS, Randell TL, Donaghue KC, Ambler GR, van Asperen PP, Mellis CM. Adrenal crises in children treated with high-dose inhaled corticosteroids for asthma. Med J Aust 2003; 178(5): 214-216.
10. Todd GR, Acerini CL, Ross-Russell R, Zahra S, Warner JT, McCance D. Survey of adrenal crisis associated with inhaled corticosteroids in the United Kingdom. Arch Dis Child 2002; 87(6): 457-461.
11. Ayres JG, Millar AB, Sykes AP. Clinical efficacy and safety of fluticasone propionate 1 mg twice daily administered via a HFA 134a pressurized metered dose inhaler to patients with severe asthma. U.K. study group. Respir Med 2000; 94(Suppl B): S42-S50.
12. Kunka R, Andrews S, Pimazzoni M, et al. From hydrofluoroalkane pressurized metered dose inhalers (pMDIs) and comparability with chlorofluorocarbon pMDIs. Respir Med 2000; 94(Suppl B): S10-S16.
13. Perruchoud AP, Lundback B, Yigla M, Sykes AP. Clinical efficacy and safety of fluticasone propionate 1 mg per day administered via a HFA 134a pressurized metered dose inhaler to patients with moderate to severe asthma. International study group. Respir Med 2000; 94(Suppl B): S35-S41.
14. Stone DWG, Mairs MA, Willits L, Sharma RK. A comparison of fluticasone propionate, 100 mg twice daily, administered via a CFC and non-CFC propellant, HFA 134a, in adult patients with asthma. Clin Drug Invest 2001; 21(10): 695-703.
15. Tonnel AB, Bons J, Legendre M, et al. Clinical efficacy and safety of fluticasone propionate 250 microg twice daily administered via a HFA 134a pressurized metered dose inhaler to patients with mild to moderate asthma. French study group. Respir Med 2000; 94(Suppl B): S29-S34.
16. Shakir SAW. Prescription-event monitoring. In Pharmacoepidemiology (4th edn), Strom BL (ed.). John Wiley & Sons Ltd: Chichester, UK, 2005; 203-216.
17. Shakir SAW. Causality and correlation in pharmacovigilance. In Stephens' Detection Of New Adverse Drug Reactions (5th edn), Talbot J, Waller P (eds). John Wiley & Sons Ltd: Chichester, UK, 2003: 329-343.
18. CIOMS/WHO. International ethical guidelines for biomedical research involving human subjects, Geneva, 2002.
19. Royal College of Physicians of London. Guidelines on the practice of ethical research involving human subjects, 1996.
20. Multi-centre research ethics committees guidance notes, 2000. Appendix C-page 19. http://www.corec.org.uk/wordDocs/guideNotes.doc.
21. General Medical Council. Confidentiality: protecting and providing information. Frequently Asked Questions Q7, p 9. 2004.
22. Allen & Hanburys. Flixotide Evohaler, Summary of product characteristics, 2006.
23. Heeley E, Riley J, Layton D, Wilton LV, Shakir SA. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358: 1872-1873.
24. Martin RM, Kapoor KV, Wilton LV, Mann RD. Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice: observational study. Br Med J 1998; 317(7151): 119-120.
25. Templeton L, Deehan A, Taylor C, Drummond C, Strang J. Surveying general practitioners: does a low response rate matter? Br J General Pract 1997; 47: 91-94.
26. Fleming DM, Cross KW, Sunderland R, Ross AM. Comparison of the seasonal patterns of asthma identified in general practitioner episodes, hospital admissions, and deaths. Thorax 2000; 55: 662-665.
27. Wong JY, Zacharin MR, Hocking N, Robinson PJ, Growth and, adrenal suppression in asthmatic children on moderate to high doses of fluticasone propionate. J Paediatr Child Health 2002; 38(1): 59-62.
28. Sim D, Giiffiths A, Armstrong D, Clarke C, Rodda C, Freezer N. Adrenal suppression from high-dose inhaled fluticasone propionate in children with asthma. Eur Respir J 2003; 21(4): 633-636.
29. Visser MJ, van der Veer E, Postma DS, et al. Side-effects of fluticasone in asthmatic children: no effects after dose reduction. Eur Respir J 2004; 24(3): 420-425.
30. National Institute of Clinical Excellence. Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in primary and secondary care. Clinical Guideline 12, 2004.
31. Bonay M, Bancal C, Crestani B. Benefits and risks of inhaled corticosteroids in chronic obstructive pulmonary disease. Drug Saf 2002; 25(1): 57-71.
32. Man SFP, Sin DD. Inhaled corticosteroids in chronic obstructive pulmonary disease. Drug Saf 2005; 65(5): 579-591.
33. Lyttle B, Gilles J, Panov M, Emeryk A, Wixon C. Fluticasone propionate 100 microg bid using a non-CFC propellant, HFA 134a, in asthmatic children. Can Respir J 2003; 10(2): 103-109.
34. International Conference on Harmonisation of Technical Requirements for Registration of Medicinal Products for Human Use. Pharmacovigilance Planning E2E, 2004; www.ich.org [last accessed 23/08/ 2006].
35. European Medicines Agency. Guideline on Risk Management Systems for Medicinal Products for Human Use. CHMP/96268 November 2005 http://www.emea.europa.eu/pdfs/human/euleg/9626805en.pdf [last accessed 04/12/2006].
36. Bahri P, Tsintis P. Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH). Pharmacoepidemiol Drug Saf 2005; 14(6): 377-387.
37. Tsintis P, La ME. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications. Drug Saf 2004; 27(8): 509-517.