Ross-Degnan D, Soumerai S B, Fortess E E, Gurwitz J H
Department of Social Medicine, Harvard Medical School, Boston, MA 02215.
JAMA. 1993 Oct 27;270(16):1937-42.
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.
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.
Study physicians provided outpatient pharmaceutical care to patients enrolled in the New Jersey Medicaid program.
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.
Monthly rates of prescribing for zomepirac and several categories of substitute analgesics among Medicaid patients seen by study physicians.
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 -2.8% of total analgesic prescribing, respectively; P < .001). After the product's withdrawal from the market, zomepirac prescribers showed significant increases in relative prescribing of other NSAIDs (+6.8%; P < .001), propoxyphene (+2.1%; P < .05), and analgesics containing barbiturates (+2.7%; P < .001).
The sudden withdrawal of zomepirac from the market resulted in substitutions not only of other NSAIDs, but also of alternative analgesics that carry risks of habituation and adverse effects. Apparent gains in patient safety resulting from market withdrawal of medications must be evaluated in comparison with risks of medications likely to be substituted.
在反复有与佐美酸相关的死亡报告后，研究非甾体抗炎药（NSAID）佐美酸纳进入市场及随后撤出市场后镇痛药处方的变化。
为评估这个自然准实验，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情况。
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名在研究期间为佐美酸开具10张或更多处方的初级保健医生（佐美酸处方医生），以及308名在医疗补助计划中为除佐美酸之外的其他NSAID开具10张或更多处方的医生（其他NSAID处方医生）。
研究医生诊治的医疗补助计划患者中，佐美酸及几类替代镇痛药的月处方率。
在佐美酸处方医生队列中，佐美酸占镇痛药处方的比例稳定在11.0%；在产品撤出市场前11个月的标签更改和制造商产品风险警告对其使用没有影响。进入市场后，与其他NSAID处方医生相比，佐美酸处方医生减少了其他NSAID和丙氧芬（盐酸盐或萘磺酸盐）的使用（分别占总镇痛药处方的-8.1%和-2.8%；P<.001）。产品撤出市场后，佐美酸处方医生在其他NSAID（+6.8%；P<.001）、丙氧芬（+2.1%；P<.05）和含巴比妥类药物的镇痛药（+2.7%；P<.001）的相对处方量上有显著增加。
佐美酸突然撤出市场不仅导致了其他NSAID的替代，还导致了有成瘾和不良反应风险的替代镇痛药的替代。药物撤出市场带来的患者安全性的明显提高，必须与可能被替代药物的风险相比较来评估。
