Rates of abuse of tramadol remain unchanged with the introduction of new branded and generic products:: results of an abuse monitoring system, 1994-2004
Rates of abuse of tramadol remain unchanged with the introduction of new branded and generic products:: results of an abuse monitoring system, 1994-2004
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DOI：
10.1002/pds.1113
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发表时间：
2005-12-01
影响因子：
2.6
通讯作者：
Mu単oz, A
中科院分区：
文献类型：
--
作者：
Cicero, TJ;Inciardi, JA;Mu単oz, A
目的止痛药盐酸曲马多(Ultram(TM))于1994年被批准为CSA的非附表药物，条件是独立指导委员会(ISC)将制定一项新的风险管理计划。FISK管理计划始于1995年推出Ultram，并在过去十年中进行了修改，以适应2001年的Ultraet(Ultram和对乙酰氨基酚)和2002年的非专利曲马多。这为研究滥用的潜在变化提供了一个独特的机会。方法为了积极主动地发现滥用和转移的案例，ISC开发了一份全面的问卷，由广泛的药物滥用专家网络(n=309)和警察机构(n=100)每季度完成，他们被要求指出在过去3个月中发现了多少涉及Ultram、Ultraet和非专利曲马多的转移案例，以及在此期间他们的集水区内最常被转移的10种药物是什么。结果和结论产生的数据表明，尽管有新的品牌和仿制药，曲马多的滥用仍然非常低。与廉价的仿制药会导致更高的滥用比率的假设相反，我们发现，随着仿制药曲马多的引入，滥用没有增加。与其他广泛使用的氢可酮和羟考酮组合产品不同的是，Ultraet的滥用比率甚至低于曲马多的观察结果。由于FDA现在要求对新药实施积极的FISK管理计划，曲马多风险管理计划可能是有用的原型模型，可以修改以适应其他具有滥用潜力的药物。版权所有(C)2005 John Wiley&Sons，Ltd.
Purpose The analgesic Tramadol HCI (Ultram (TM)) was approved in 1994 as a non-scheduled drug under the CSA provided that a novel risk-management program would be developed by an Independent Steering Committee (ISC). The fisk-management program began in 1995 with the launch of Ultram, and has been modified over the past decade to accommodate Ultracet (Ultram and acetaminophen) in 2001 and generic tramadol in 2002. This provided a unique opportunity to study the potential changes in abuse as the generic and combination products became available.Methods To proactively detect cases of abuse and diversion, the ISC developed a comprehensive questionnaire which was completed quarterly by an extensive network of drug abuse experts (n = 309) and police agencies (n = 100) who were asked to indicate how many diversion cases involving Ultram, Ultracet, and generic tramadol were identified during the preceding 3 months and what were the ten most commonly diverted drugs in their catchment area during that period.Results and Conclusions The data generated demonstrate that the abuse of tramadol remained very low despite new branded and generic formulations. Contrary to the hypothesis that cheaper generic drugs would lead to higher rates of abuse, we found no increase in abuse with the introduction of generic tramadol. Ultracet abuse rates, unlike those found with other widely used hydrocodone and oxycodone combination products, have been even lower than that observed for tramadol. Since the FDA has now mandated that proactive fisk-management plans be implemented for new drugs, the tramadol risk-management plan may be useful as a prototypic model which can be modified to accommodate other drugs with abuse potential. Copyright (c) 2005 John Wiley & Sons, Ltd.