Drug Safety

, Volume 27, Issue 8, pp 519–534

Communication of Medical Product Risk

How Effective is Effective Enough?
Leading Article

Abstract

Ever-increasing attention is being paid worldwide to the safety of medical products, and the risks associated with their use. The integral role of risk communication in overall risk management is demonstrated by several recent market withdrawals of drugs, in which a perceived incapability of healthcare systems to manage well-characterised, avoidable risks was a significant factor.

With advances in clinical pharmacology, pharmacogenomics and pharmacoepidemiology expanding our knowledge of medical products, effective delivery of the latest safety-related information to health professionals and consumers becomes even more imperative. In this regard, it is important to evaluate whether current modes of risk communication lead to desired changes in relevant behaviours such as prescribing or drug monitoring, particularly in context with which achieved level of effectiveness is deemed acceptable. This is crucial, as there have been product-specific risk communication efforts that achieved a fair degree of success, yet were not seen as effective enough to prevent market withdrawal of the medical product in question.

In the service of improving public health through enhanced risk communication, it is essential to critically assess current methods, both as to results achieved (or not), and whether each method is applicable to the various types of risks associated with medical product use. Furthermore, just as combining methods may well improve overall risk communication, there are societal and psychological factors that must be considered in attempting to maximise effectiveness. However, in assessing risk communication effectiveness, the particular benefit-risk relationship of any individual medical product must also be part of the evaluative process.

References

  1. 1.
    Task Force on Risk Management. Report to the FDA Commissioner: managing the risks from medical product use: creating a risk management framework. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1999 MayGoogle Scholar
  2. 2.
    International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline E2A: clinical safety data management: definitions and standards for expedited reporting [online]. Available from URL: http://www.ich.org/UrlGrpServer.jser?.@_ID=276&@_TEMPLATE=254 [Accessed 2004 Jan 25]Google Scholar
  3. 3.
    CIOMS IV Working Group. Benefit-risk balance for marketed drugs: evaluating safety signals. Geneva: Council For International Organizations Of Medical Sciences, 1998Google Scholar
  4. 4.
    Presidential/Congressional Commission on Risk Assessment and Risk Management. Framework for environmental health risk management: final report, vol. 1. 1997Google Scholar
  5. 5.
    Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med 1993; 8: 289–94PubMedCrossRefGoogle Scholar
  6. 6.
    US Department of Health and Human Services, Food and Drug Administration. Notice of public workshop, request for comments. Fed Regist 2003 Mar 7; 68 (45): 11120–1Google Scholar
  7. 7.
    CDER/CBER Risk Assessment Working Group. Rockville, MD. US Department of Health and Human Services, Food and Drug Administration. 3 Mar 2003. Available from URL: http://www.fda.gov/cder/meeting/riskmanagement.htm [Accessed 2004 Jan 25]Google Scholar
  8. 8.
    Honig P, Phillips J, Woodcock J. How many deaths are due to medical errors? [letter]. JAMA 2000 Nov 1; 284(17): 2187–8PubMedCrossRefGoogle Scholar
  9. 9.
    van Grootheest ACK, Edwards IR. Labelling and ‘Dear Doctor’ letters: are they noncommittal? Drug Saf 2002; 25(15): 1051–5PubMedCrossRefGoogle Scholar
  10. 10.
    Seligman PJ. ‘Dear Doctor…’- evaluating the impact of risk communication efforts. Pharmacoepidemiol Drug Saf 2003 Jun; 12(4): 291–3PubMedCrossRefGoogle Scholar
  11. 11.
    Honig PK, Woosley RL, Zamani K, et al. Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin. Clin Pharmacol Ther 1992 Sep; 52(3): 231–8PubMedCrossRefGoogle Scholar
  12. 12.
    Honig PK, Wortham DC, Zamani K, et al. Terfenadine-ketoconazole interaction: pharmacokinetic and electrocardiographic consequences. JAMA 1993 Mar 24/31; 269(12): 1513–8PubMedCrossRefGoogle Scholar
  13. 13.
    Woosley RL, Chen Y, Freiman JP, et al. Mechanism of the cardiotoxic actions of terfenadine. JAMA 1993 Mar 24/31; 269(12): 1532–6PubMedCrossRefGoogle Scholar
  14. 14.
    Burkhart GA, Sevka MJ, Temple R, et al. Temporal decline in filling prescriptions for terfenadine closely in time with those for either ketoconazole or erythromycin. Clin Pharmacol Ther 1997 Jan; 61(1): 93–6PubMedCrossRefGoogle Scholar
  15. 15.
    Thompson D, Oster G. Use of terfenadine and contraindicated drugs. JAMA 1996 May 1; 275(17): 1339–41PubMedCrossRefGoogle Scholar
  16. 16.
    Carlson AM, Morris LS. Coprescription of terfenadine and erythromycin or ketoconazole: an assessment of potential harm. J Am Pharm Assoc (Wash) 1996 Apr; NS36(4): 263–9Google Scholar
  17. 17.
    Cavuto NJ, Woosley RL, Sale M. Pharmacies and prevention of potentially fatal drug interactions [letter]. JAMA 1996 Apr 10; 275(14): 1086PubMedCrossRefGoogle Scholar
  18. 18.
    US Food and Drug Administration. FDA proposes to withdraw Seldane approval [Talk Paper]. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1997 Jan 13Google Scholar
  19. 19.
    Klausner MA. Dear doctor letter. Titusville (NJ): Janssen Pharmaceutica Research Foundation, 1998 Jun 26Google Scholar
  20. 20.
    US Food and Drug Administration. FDA strengthens warning label for Propulsid [Talk Paper]. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1998 Jun 29Google Scholar
  21. 21.
    Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cispapride: impact of Food and Drug Administration regulatory action. JAMA 2000 Dec 20; 284(23): 3036–9PubMedCrossRefGoogle Scholar
  22. 22.
    Weatherby LB, Walker AM, Fife D, et al. Contraindicated medications dispensed with cispapride: temporal trends in relation to the sending of ‘Dear Doctor’ letters. Pharmacoepidemiol Drug Saf 2001 May; 10(3): 211–8PubMedCrossRefGoogle Scholar
  23. 23.
    Jones JK, Fife D, Curkendall S, et al. Coprescribing and codispensing of cispapride and contraindicated drugs. JAMA 2001 Oct 3; 286(13): 1607–9PubMedCrossRefGoogle Scholar
  24. 24.
    De Bruin ML, Panneman MJM, Leufkens HGM, et al. Use of cispapride with contraindicated drugs in The Netherlands. Ann Pharmacother 2002 Feb; 36: 338–43PubMedCrossRefGoogle Scholar
  25. 25.
    Centrale Medisch Pharmaceutische Commissie. Farmacotherapeutisch Kompas 1999. Amstelveen, Netherlands: Ziekenfondsraad, 1999Google Scholar
  26. 26.
    McMullin ST, Reichley RM, Watson LA, et al. Impact of a Web-based clinical information system on cisapride drug interactions and patient safety. Arch Intern Med 1999 Sep 27; 159: 2077–82PubMedCrossRefGoogle Scholar
  27. 27.
    Cahill JA. Responsibilities of physicians and pharmacists in preventing drug interactions [letter]. JAMA 2002 Feb 6; 287(5): 586PubMedCrossRefGoogle Scholar
  28. 28.
    US Food and Drug Administration. Janssen Pharmaceutica stops marketing cisapride in the US [Talk Paper]. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 2000 Mar 23Google Scholar
  29. 29.
    de Vane PJ. Dear health care professional letter. Bronx (NY): Wyeth-Ayerst Laboratories, 1998 FebGoogle Scholar
  30. 30.
    US Food and Drug Administration. Warning label changes for pain reliever Duract [Talk Paper]. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1998 Feb 10Google Scholar
  31. 31.
    US Food and Drug Administration. Wyeth-Ayerst Laboratories announces the withdrawal of Duract from the market [Talk Paper]. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1998 Jun 22Google Scholar
  32. 32.
    Friedman MA, Woodcock J, Lumpkin MM, et al. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999 May 12; 281(18): 1728–34PubMedCrossRefGoogle Scholar
  33. 33.
    US Food and Drug Administration, Center for Drug Evaluation and Research. Drug Approvals for January 1997. Available from URL: http://www.fda.gov/cder/da/da0197.htm [Accessed 2004 Feb 20]Google Scholar
  34. 34.
    US Department of Health and Human Services. HHS News: Rezulin to be withdrawn from the market. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 2000 Mar 21Google Scholar
  35. 35.
    Sigmund II WR. Dear healthcare professional letter. Morris Plains (NJ): Parke-Davis, 1997 Oct 28Google Scholar
  36. 36.
    Sigmund II WR. Dear healthcare professional letter. Morris Plains (NJ): Parke-Davis, 1997 Dec 1Google Scholar
  37. 37.
    Sigmund II WR. Dear healthcare professional letter. Morris Plains (NJ): Parke-Davis, 1998 Jul 28Google Scholar
  38. 38.
    Sigmund II WR. Dear healthcare professional letter. Morris Plains (NJ): Parke-Davis, 1999 Jun 16Google Scholar
  39. 39.
    Graham DJ, Drinkard CR, Shatin D, et al. Liver enzyme monitoring in patients treated with troglitazone. JAMA 2001 Aug 15; 286(7): 831–3PubMedCrossRefGoogle Scholar
  40. 40.
    Pierce M. Presentation at Endocrinologic and Metabolic Drugs Advisory Committee, 1999 Mar 26. Available from URL: http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3499t1c.pdf [Accessed 2004 Apr 13]
  41. 41.
    Sturkenboom MCJM, de Jong-van den Berg LTW, Cornel MC, et al. Communicating a drug alert: a case study on acitretin in The Netherlands. Eur J Clin Pharmacol 1994; 47: 125–32PubMedCrossRefGoogle Scholar
  42. 42.
    Howard WB, Willhite CC. Toxicology of retinoids in humans and animals. J Toxicol Toxin Rev 1986; 5: 55–96Google Scholar
  43. 43.
    DiGiovanna JJ, Zech LA, Ruddel ME, et al. Etretinate: persistent serum levels after long-term therapy. Arch Dermatol 1989 Feb; 125(2): 246–51PubMedCrossRefGoogle Scholar
  44. 44.
    Lumpkin MM. FDA Public Health Advisory. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1997 Dec 15Google Scholar
  45. 45.
    US Food and Drug Administration. Q & A’s: low molecular weight heparins/ heparinoids and spinal/epidural anesthesia. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1998 May 6Google Scholar
  46. 46.
    US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Promoting and protecting the public health: annual report fiscal year 1999. Available from URL: http://www.fda.gov/cdrh/annual/annualreport99.html [Accessed 2004 Feb 15]Google Scholar
  47. 47.
    Jacobson ED. Potential cross-contamination linked to hemodialysis treatment [Safety Alert]. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 1999 MayGoogle Scholar
  48. 48.
    Feigal Jr DW, Woodcock J. Potential for injury from medical gas misconnections of cryogenic vessels [Public Health Advisory]. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, 2001 Jul 20Google Scholar
  49. 49.
    US Food and Drug Administration, Center for Devices and Radiological Health. Safety Alerts, Public Health Advisories and notices from CDRH. Available at URL: http://www.fda.gov/cdrh/safety.html [Accessed 2004 Jan 5]Google Scholar
  50. 50.
    Weatherby LB, Nordstrom BL, Fife D, et al. The impact of wording in “Dear doctor” letters and in black box labels. Clin Pharmacol Ther 2002 Dec; 72(6): 735–42PubMedCrossRefGoogle Scholar
  51. 51.
    Guo JJ, Curkendall S, Jones JK, et al. Impact of cispapride label changes on codispensing of contraindicated medications. Pharmacoepidemiol Drug Saf 2003 Jun; 12(4): 295–301PubMedCrossRefGoogle Scholar
  52. 52.
    Soumerai SB, Avorn J. Principles of educational outreach (‘academic detailing’) to improve clinical decision making. JAMA 1990 Jan 26; 263(4): 549–56PubMedCrossRefGoogle Scholar
  53. 53.
    Manning PR, Lee PV, Clintworth WA, et al. Changing prescribing practices through individual continuing education. JAMA 1986 Jul 11; 256(2): 230–2PubMedCrossRefGoogle Scholar
  54. 54.
    Anderson GM, Lexchin J. Strategies for improving prescribing practice. CMAJ 1996 Apr 1; 154(7): 1013–7PubMedGoogle Scholar
  55. 55.
    Grimshaw JM, Shirran L, Thomas R, et al. Changing provider behavior: an overview of systematic reviews of interventions. Med Care 2001 Aug; 39(8 Suppl. 2): II2–45PubMedGoogle Scholar
  56. 56.
    May FW, Rowett DS, Gilbert AL, et al. Outcomes of an educational-outreach service for community medical practitioners: non-steroidal anti-inflammatory drugs. Med J Aust 1999 May; 170(10): 471–4PubMedGoogle Scholar
  57. 57.
    Roughead EE, Gilbert AL, Primrose JG. Improving drug use: a case study of events which led to changes in use of flucloxacillin in Australia. Soc Sci Med 1999; 48: 845–53PubMedCrossRefGoogle Scholar
  58. 58.
    Derby LE, Jick H, Henry DA, et al. Cholestatic hepatitis associated with flucloxacillin. Med J Aust 1993 May 3; 158(9): 596–600PubMedGoogle Scholar
  59. 59.
    Jick H, Derby LE, Dean AD, et al. Flucloxacillin and cholestatic hepatitis [letter]. Med J Aust 1994 Apr 18; 160(8): 525PubMedGoogle Scholar
  60. 60.
    Fairley CK, McNeil JJ, Desmond P, et al. Risk factors for development of flucloxacillin associated jaundice. BMJ 1993 Jan 23; 306(6872): 233–5PubMedCrossRefGoogle Scholar
  61. 61.
    Department of Human Services and Health. Schedule of pharmaceutical benefits for approved pharmacists and medical practitioners, August 1993. Canberra: Australian Government Publishing Service, 1993Google Scholar
  62. 62.
    Department of Human Services and Health. Schedule of pharmaceutical benefits for approved pharmacists and medical practitioners, August 1994. Canberra: Australian Government Publishing Service, 1994Google Scholar
  63. 63.
    Edwards IR, Hugman B. The challenge of effectively communicating risk-benefit information. Drug Saf 1997 Oct; 17(4): 216–27PubMedCrossRefGoogle Scholar
  64. 64.
    Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions: results of the Rhode Island Adverse Drug Reaction Reporting Project. JAMA 1990 Apr 4; 263(13): 1785–8PubMedCrossRefGoogle Scholar
  65. 65.
    Schlienger RG, Luscher TF, Schoenenberger RA, et al. Academic detailing improves identification and reporting of adverse drug events. Pharm World Sci 1999; 21(3): 110–5PubMedCrossRefGoogle Scholar
  66. 66.
    Juergens JP, Szeinbach SL, Janssen MJ, et al. An evaluation of interventions designed to stimulate physician reporting of adverse drug events. Top Hosp Pharm Manage 1992 Jul; 12(2): 12–8PubMedGoogle Scholar
  67. 67.
    Goldman SA, Lieberman R, Kausal DJ. Teaching healthcare professionals about drug-induced disease: an innovative clinical therapeutic approach. J Clin Pharmacol 1996 May; 36(5): 386–96PubMedGoogle Scholar
  68. 68.
    Goldman SA, Kennedy DL, Lieberman R, editors. Clinical therapeutics and the recognition of drug-induced disease [MedWatch Continuing Education Article]. Rockville (MD): Food and Drug Administration, 1995 Jun. Available from URL: http://www.fda.gov/medwatch/articles.htm [Accessed 2004 May 10]Google Scholar
  69. 69.
    Goldman SA. Use of a mail-out continuing education article to teach health professionals about drug-induced disease. J Clin Pharmacol 1999 Nov; 39(11): 1126–35PubMedGoogle Scholar
  70. 70.
    Goldman SA. The clinical impact of adverse event reporting [MedWatch Continuing Education Article]. Rockville (MD): Food and Drug Administration, 1996 Oct. Available from URL: http://www.fda.gov/medwatch/articles.htm [Accessed 2004 May 10]Google Scholar
  71. 71.
    White GG, Weick-Brady MD. Improving patient care by reporting problems with medical devices [MedWatch Continuing Education Article]. Rockville (MD): Food and Drug Administration, 1997 Sep. Available from URL: http://www.fda.gov/medwatch/articles.htm [Accessed 2004 May 10]Google Scholar
  72. 72.
    Alaszewski A, Horlick-Jones T. How can doctors communicate information about risk more effectively? BMJ 2003 Sep 27; 327(7417): 728–31PubMedCrossRefGoogle Scholar
  73. 73.
    Gigerenzer G, Edwards A. Simple tools for understanding risks: from innumeracy to insight. BMJ 2003 Sep 27; 327(7417): 741–4PubMedCrossRefGoogle Scholar
  74. 74.
    Aronson JK, Derry S, Loke YK. Adverse drug reactions: keeping up to date. Fundam Clin Pharmacol 2002 Feb; 16(1): 49–56PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2004

Authors and Affiliations

  1. 1.Stephen A. Goldman Consulting Services L.L.C.Morris PlainsUSA

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