EXAMINING PRODUCT RISK IN CONTEXT - MARKET WITHDRAWAL OF ZOMEPIRAC AS A CASE-STUDY
EXAMINING PRODUCT RISK IN CONTEXT - MARKET WITHDRAWAL OF ZOMEPIRAC AS A CASE-STUDY
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DOI：
10.1001/jama.270.16.1937
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发表时间：
1993-10-27
影响因子：
120.7
通讯作者：
GURWITZ, JH
中科院分区：
文献类型：
--
作者：
ROSSDEGNAN, D;SOUMERAI, SB;GURWITZ, JH
客观。-为了检查在进入市场后镇痛药处方的变化和随后的撤药佐美拉克钠，一种非甾体抗炎药（NSAID），反复报告佐美拉克相关死亡。为了评估这个自然的准实验，我们进行了时间序列分析，以比较1980年7月至1983年9月两组初级保健医生的处方。研究医生为参加新泽西医疗补助计划的患者提供门诊药物治疗。我们确定了260名初级保健医生谁提供了10个或更多的处方佐美拉克（佐美拉克处方者）和308谁提供了10个或更多的处方非甾体抗炎药以外的佐美拉克（其他非甾体抗炎药处方者）在研究期间的医疗补助。研究医生观察到的医疗补助患者中佐美拉克和几种替代镇痛药的每月处方率。在佐美匹拉克处方者队列中，佐美匹拉克占镇痛药处方的11.0%;产品退出市场前11个月的标签变更和制造商产品风险警告对使用没有影响。进入市场后，与其他NSAID处方者相比，佐美酸处方者减少了其他NSAID和丙氧芬（盐酸盐或萘磺酸盐）的使用（分别占镇痛药处方总量的-8.1%和-2.80%; P
Objective.-To examine changes in the prescribing of analgesics after the market entry and subsequent withdrawal of zomepirac sodium, a nonsteroidal anti-inflammatory drug (NSAID), following repeated reports of zomepirac-related deaths.Design.-To evaluate this natural quasi experiment, we conducted time-series analyses to compare prescribing in two cohorts of primary care physicians from July 1980 through September 1983.Setting.-Study physicians provided outpatient pharmaceutical care to patients enrolled in the New Jersey Medicaid program.Participants.-We identified 260 primary care physicians who provided 10 or more prescriptions for zomepirac (zomepirac prescribers) and 308 who provided 10 or more prescriptions for NSAIDs other than zomepirac (other-NSAID prescribers) in Medicaid during the study period.Main Outcome Measures.-Monthly rates of prescribing for zomepirac and several categories of substitute analgesics among Medicaid patients seen by study physicians.Main Results.-Zomepirac accounted for a stable 11.0% of analgesic prescribing among the zomepirac-prescriber cohort; label changes and manufacturer product-risk warnings 11 months before the product's withdrawal from the market had no impact on use. After market entry, zomepirac prescribers reduced use of other NSAIDs and propoxyphene (hydrochloride or napsylate) in comparison with other-NSAID prescribers (-8.1% and -2.80% of total analgesic prescribing, respectively; P