The Impact of a Drug Safety Warning on Discussions between Doctors and Their Patients; the Case of Rosiglitazone

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

Breaking away from dopamine deficiency: an essential new direction for Parkinson’s disease

“…Overdosing, inhibitory effects of DART, and events related to impaired circadian function (Boulamery et al , 2010 ) could well determine the severity of the disorder and advancement of the disease as it is linked to drug-induced phenomena (Barbeau , 1974 ;Lesser et al , 1979 ;Eriksson et al , 1984 ;Ogawa , 1994 ). The production of Parkinsonian symptoms by the administration of DART itself is a vital area that needs reinforcement in the clinic where there is evidence of a general resistance to changing established dosing practices (Nuovo , 2011 ). Until this occurs, research into key areas such as early diagnosis (Meara et al , 1999 ;Berg , 2008 ) are futile in that we would be increasing risk of developing debilitating side effects earlier as we insist on maintaining the current narrow focus on DART.…”