The Impact of a Drug Safety Warning on Discussions between Doctors and Their Patients; the Case of Rosiglitazone
Author(s)
Jim Nuovo
ABSTRACT
The goal of this study was to track the influence of a highly publicized report on discussions between doctors and their patients and prescribing decisions made in response to concerns about potential medication adverse side effects. This was a retrospective analysis of a primary care network’s electronic medical record database. From a diabetes registry of 12, 246 patients, 329 were identified as taking rosiglitazone prior to the June 14, 2007 release of an article in the New England Journal of Medicine; the article suggesting an increased risk of myocardial events. The entire content of all office visits, telephone messages, and medication lists for each patient were reviewed over a 2-year period subsequent to the article’s publication. Doctor/patient discussions regarding concerns for rosiglitazone were catalogued including the physician’s treatment recommendations. There were documented discussions on rosiglitazone’s potential adverse side effects for 64 patients; 19.5 percent of this population. All of the discussions occurred between June 15 and October 30, 2007. Of the entire group, 59.3 percent (N = 195) remained on rosiglitazone. For those advised to continue rosiglitazone, the provider indicated that he/she wanted more data before determining if the drug was not safe or discounted the validity of the safety concerns. For those advised to discontinue rosiglitazone, 112 (83.6 percent) were placed on pioglitazone. An article suggesting potential adverse effects of rosiglitazone resulted in a documented discussion in 19.5 percent of patients on this medication. These findings suggest an awareness of this publication by patients, presumably derived from media reports. However, an awareness of this concern did not result in a substantial change in practice.The majority of patients remained on rosiglitazone. The content of these discussions suggest that most physicians’ recommended waiting for more published data before considering a change. While many factors influence physician’s prescribing behavior, this study demonstrates how a highly publicized report influences the doctor/ patient dialogue.
The goal of this study was to track the influence of a highly publicized report on discussions between doctors and their patients and prescribing decisions made in response to concerns about potential medication adverse side effects. This was a retrospective analysis of a primary care network’s electronic medical record database. From a diabetes registry of 12, 246 patients, 329 were identified as taking rosiglitazone prior to the June 14, 2007 release of an article in the New England Journal of Medicine; the article suggesting an increased risk of myocardial events. The entire content of all office visits, telephone messages, and medication lists for each patient were reviewed over a 2-year period subsequent to the article’s publication. Doctor/patient discussions regarding concerns for rosiglitazone were catalogued including the physician’s treatment recommendations. There were documented discussions on rosiglitazone’s potential adverse side effects for 64 patients; 19.5 percent of this population. All of the discussions occurred between June 15 and October 30, 2007. Of the entire group, 59.3 percent (N = 195) remained on rosiglitazone. For those advised to continue rosiglitazone, the provider indicated that he/she wanted more data before determining if the drug was not safe or discounted the validity of the safety concerns. For those advised to discontinue rosiglitazone, 112 (83.6 percent) were placed on pioglitazone. An article suggesting potential adverse effects of rosiglitazone resulted in a documented discussion in 19.5 percent of patients on this medication. These findings suggest an awareness of this publication by patients, presumably derived from media reports. However, an awareness of this concern did not result in a substantial change in practice.The majority of patients remained on rosiglitazone. The content of these discussions suggest that most physicians’ recommended waiting for more published data before considering a change. While many factors influence physician’s prescribing behavior, this study demonstrates how a highly publicized report influences the doctor/ patient dialogue.
Cite this paper
nullJ. Nuovo, "The Impact of a Drug Safety Warning on Discussions between Doctors and Their Patients; the Case of Rosiglitazone," Pharmacology & Pharmacy, Vol. 2 No. 3, 2011, pp. 168-172. doi: 10.4236/pp.2011.23024.
nullJ. Nuovo, "The Impact of a Drug Safety Warning on Discussions between Doctors and Their Patients; the Case of Rosiglitazone," Pharmacology & Pharmacy, Vol. 2 No. 3, 2011, pp. 168-172. doi: 10.4236/pp.2011.23024.
References
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[1] Yki-Jarvinen H, Thiazolidinediones. N Engl J Med 2004; 351:1106-18. [2] Nissen SE, Wolski K. Effect of rosiglita-zone on the risk of myocardial infarction and death from car-diovascular causes. N Engl J Med 2007; 356:2457-71. [3] Hersh AL, Ste MJ, Stafford RS. National use of posmenopausal hormone thrapy. Annual trends and re-sponse to recent evidence. JAMA 2004; 291:47-53. [4] Majumdar SR, Almasi EA, Stafford RS. Pro-motion and prescribing of hormone therapy after report of harm by the women’s health initiative. JAMA 2004; 292:1983-88. [5] Hsiao F-Y, Tsai Y-W, Huang W-F. Changes in physician’s practice of prescribing cyclooxy-genase-2 inhibitor after market withdrawal of rofecoxib: a ret-rospective study of physician-patient pairs in Taiwan. Clin Ther +2009; 31:2618-27. [6] Geraghty EM, Balsbaugh T, Nuovo J, Tandon S. Using geographic information systems (GIS) to assess outcome disparities in patients with type 2 diabetes and hyperlipidemia. J Am Board Fam Med 2010; 23:88-96. [7] Majumdar SR, Inui TS, Gurwitz JH, et al. In-fluence of physician specialty on adoption and relinquishment of calcium channel blockers and other treatments for myocar-dial infarction. J Gen Intern Med 2001; 16:351-59. [8] Cohen A, Rabbani A, Shah N, Alexander GC. Changes in glitazone use among office-based physicians in the U.S., 2003-2009. Diabetes Care 2010; 33:823-5. [9] Faber A, Bouvy ML, Loskamp L, et al. Dramatic change in prescribing of hormone replacement therapy in the Netherlands after publication of the Million Women Study: a follow-up study. Br J Clin Pharmacol 2005; 60: 641-7. [10] Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patient’s requests for direct-to-consumer advertised antidepressants. A randomized controlled trial. JAMA 2005; 293:1995-2002. [11] Garfield E. The history and meaning of the journal impact factor. JAMA 2006; 295:90-3. [12] Greene JA, Kesselheim AS. Pharmaceutical marketing and the new social media. N Engl J Med 2010; 363:2087- 9. [13] Shah ND, Montori VM, Krumholz HM, et al. Responding to an FDA warning-Geographic variation in the use of rosiglitazone. N Engl J Med 2010;363:2081-4.