Communicating drug risk to physicians: Challenges and opportunities

International Journal of Risk and Safety in Medicine

Volumn 20, Issue 3, 2008, Pages 143-154

  Morrato, Elaine H ^a,d   Curbow, Barbara ^b   Crum, Rosa M ^c   Nowels, Carolyn ^a   Feinleib, Manning ^c  

^a UNIVERSITY OF COLORADO   (United States)

^b UNIVERSITY OF FLORIDA   (United States)

^c JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^d Mail Stop F443   (United States)

Author keywords

Drug risk communication; Physicians; United States

Indexed keywords

ARTICLE; DRUG INFORMATION; DRUG MANUFACTURE; DRUG RESEARCH; DRUG SAFETY; MEDICAL EDUCATION; PHYSICIAN; RISK FACTOR;

EID: 50249182747     PISSN: 09246479     EISSN: None     Source Type: Journal    
DOI: 10.3233/JRS-2008-0437     Document Type: Article

References (38)

1. Australian Government and Department of Health and Ageing, The therapeutic goods administration's risk management approach to the regulation of therapeutic goods (Version 1 of July 2004), 2004.
2. J. Avorn, M. Chen and R. Hartley, Scientific versus commercial sources of influence on the prescribing behavior of physicians, Am. J. Med. 73 (1982), 4-8.
3. R.A. Bauer and L.H. Wortzel, Doctor's choice: The physician and his sources of information about drugs, J. Marketing Res. 3(1) (1966), 40-47.
4. M.H. Becker et al., Correlates of physician's prescribing behavior, Inquiry 3 (1972), 30-42.
5. N.L. Bennett et al., Family physicians' information seeking behaviors: A survey comparison with other specialties, BMC Med. Inf. Decision Making 5(9) (2005), doi: 10.1186/1472-6947-5-9.
6. P.F. Buckley et al., Clinicians' recognition of the metabolic adverse effects of antipsychotic medications, Schizophrenia Res. 79 (2005), 281-288.
7. M.D. Cabana et al., Why don't physicians follow clinical practice guidelines?: A framework for improvement, JAMA 282(15) (1999), 1458-1465.
8. W.H. Campbell and R.M. Califf, Improving communication of drug risks to prevent patient injury: proceedings of a workshop, Pharmacoepidemiol. Drug Saf. 12 (2003), 183-194.
9. European Medicines Agency, Guideline on risk management systems for medicinal products for human use, 2005 (cited April 30, 2007); available from: www.emea.eu.int/pdfs/human/euleg/96268053en.pdf.
10. A. Fontana and J.H. Frey, The interview: from structured questions to negotiated text, in: Handbook of Qualitative Research, N.K. Denzin and Y.S. Lincoln, eds, Sage Publications, Thousand Oaks, CA, 2000, pp. 645-672.
11. C.A. Gaither et al., Factors related to physicians' attitudes and beliefs toward drug information sources, Drug Information J. 28 (1994), 817-827.
12. M.K. Giacomini and D.J. Cook, Users' Guides to the Medical Literature. XXIII. Qualitative research in health care. A. Are the results of the study valid?, JAMA 284(3) (2000), 357-362.
13. D.J. Graham et al., Liver enzyme monitoring in patients treated with troglitazone, JAMA 286(7) (2001), 831-833.
14. G. Harris, FDA responds to criticism with new caution, The New York Times, 2005, New York.
15. Health Canada, A framework for strategic risk communications within the context of health Canada and the PHAC's integrated risk management, 2006.
16. Institute of Medicine, Committee on the Assessment of the US Drug Safety, System Board on Population Health and Public Health Practice, The Future of Drug Safety: Promoting and Protecting the Health of the Public, The National Academies Press, Washington, DC, 2006.
17. N.M.A. LaPointe et al., Practitioner acceptance of the dofetilide risk-management program, Pharmacotherapy 22(8) (2002), 1041-1046.
18. N. Mays and C. Pope, Qualitative research: rigour and qualitative research, BMJ 311 (1995), 109-112.
19. P. McGettigan et al., Prescribers prefer people: The sources of information use by doctors for prescribing suggest that the medium is more important than the message, Br. J. Clin. Phamacol. 51 (2001), 184-189.
20. F.E. Mebane, The importance of news media in pharmaceutical risk communication: proceedings of a workshop, Pharmacoepidemiol. Drug Saf. 14 (2004), 297-306; doi: 10.1002/pds.993.
21. E.H. Morrato, Impact of nefazodone (Serzone) hepatic risk minimization recommendations: A case study evaluation of an FDA boxed warning, in: Epidemiology, Johns Hopkins University, Baltimore, 2006.
22. E.H. Morrato and J.A. Staffa, Effectiveness of risk management plans: a case study of pemoline using pharmacy claims data, Pharmacoepidemiol. Drug Saf. 16(1) (2007), 104-112.
23. R. Moynihan et al., Coverage by the news media of the benefits and risks of medication, N. Engl. J. Med. 342 (2000), 1645-1650.
24. D.E. Nelson et al. (eds), Communicating Public Health Information Effectively: A Guide for Practitioners, American Public Health Association, Washington, DC, 2002.
25. S. Okie, What ails the FDA?, N. Engl. J. Med. 352(11) (2005), 1063-1066.
26. C. Pfeffer, The FDA pediatric advisories and changes in diagnosis and treatment of pediatric depression, Am. J. Psych. 164(6) (2007), 843-846.
27. Public Citizen, Lessons learned from Vioxx, the ninth drug pulled off the market long after Public Citizen warned consumers not to use, 2004 (cited November 2, 2005); available from: www.citizen.org/pressroom.
28. E.M. Rogers, Diffusion of Innovations, 5th edn, E.M. Rogers, ed., Free Press, New York, 2003.
29. J.M. Rothschild et al., Clinican use of a palmtop drug reference guide, J. Am. Med. Inform. Assoc. 9 (2002), 223-229.
30. G. Ryan and H. Bernard, Data management and analysis methods, in: Handbook of Qualitative Research, N.K. Denzin and Y.S. Lincoln, eds, Sage Publications, Thousand Oaks, CA, 2000, pp. 769-802.
31. P.J. Seligman, 'Dear Doctor. . . ' - Evaluating the impact of risk communication efforts, Pharmacoepidemiol. Drug Saf. 12 (2003), 291-293.
32. W. Smalley et al., Contraindicated use of cisapride: impact of food and drug administration regulatory action, JAMA 284(23) (2000), 3036-3039.
33. R. Stewart and P.N. Shamdasani, Analyzing focus group data, in: Focus Groups: Theory and Practice, Sage Publications, Newbury Park, 1990, pp. 102-121.
34. US Food and Drug Administration, Guidance for industry: Development and use of risk minimization action plans, March 2005 (cited April 7, 2005); available from: http://www.fda.gov/cber/guidelines.htm#minim.
35. US Food and Drug Administration, Draft Guidance: FDA's "Drug Watch" for Emerging Drug Safety Information, 2005 (cited September 30, 2005); available from: www.fda.gov/cder/drugSafety.htm.
36. US Food and Drug Administration, FDA's new drug safety initiative, 2005 (cited December 7, 2005); available from: http://www.fda.gov/cder/drugSafety. htm.
37. US Food and Drug Administration, Prescription drug user fees, 2007 (cited November 12, 2007); available from: http://www.fda.gov/oc/pdufa/default.htm.
38. US Food and Drug Administration, FDA Selects Members for Risk Communication Advisory Committee, 2007 (cited November 14, 2007); available from: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01739.html.