临床试验中误用、滥用和相关事件的分类和定义：ACTTION 系统评价和建议。
Classification and definition of misuse, abuse, and related events in clinical trials: ACTTION systematic review and recommendations.
机构信息
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA University of Colorado School of Medicine and Rocky Mountain Poison & Drug Center, Denver Health, Denver, CO, USA Analgesic Solutions, Natick, MA, USA Tufts University, Boston, MA, USA Focus Biocom, Durango, CO, USA Covance Market Access, Gaithersburg, MD, USA Columbia University, New York State Psychiatric Institute, New York, NY, USA Astellas Pharma, Inc., Northbrook, IL, USA Brigham & Women's Hospital, Boston, MA, USA Purdue Pharma LP, Stamford, CT, USA University of Maryland School of Medicine, Baltimore, MD, USA Centers for Disease Control and Prevention, Atlanta, GA, USA Collegium Pharmaceutical, Inc., Canton, MA, USA Department of Neurosurgery, University of Rochester, Rochester, NY, USA National Institute on Drug Abuse, Bethesda, MD, USA University of Pennsylvania, Philadelphia, PA, USA Pfizer Inc., Cary, NC, USA Horizon Pharma, Inc., Deerfield, IL, USA Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA Janssen Scientific Affairs, LLC, Raritan, NJ, USA Harvard Medical School, Chestnut Hill, MA, USA Harvard Medical School, Boston, MA, USA Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Department of Neurology and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
出版信息
Pain. 2013 Nov;154(11):2287-2296. doi: 10.1016/j.pain.2013.05.053. Epub 2013 Jun 20.
As the nontherapeutic use of prescription medications escalates, serious associated consequences have also increased. This makes it essential to estimate misuse, abuse, and related events (MAREs) in the development and postmarketing adverse event surveillance and monitoring of prescription drugs accurately. However, classifications and definitions to describe prescription drug MAREs differ depending on the purpose of the classification system, may apply to single events or ongoing patterns of inappropriate use, and are not standardized or systematically employed, thereby complicating the ability to assess MARE occurrence adequately. In a systematic review of existing prescription drug MARE terminology and definitions from consensus efforts, review articles, and major institutions and agencies, MARE terms were often defined inconsistently or idiosyncratically, or had definitions that overlapped with other MARE terms. The Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership convened an expert panel to develop mutually exclusive and exhaustive consensus classifications and definitions of MAREs occurring in clinical trials of analgesic medications to increase accuracy and consistency in characterizing their occurrence and prevalence in clinical trials. The proposed ACTTION classifications and definitions are designed as a first step in a system to adjudicate MAREs that occur in analgesic clinical trials and postmarketing adverse event surveillance and monitoring, which can be used in conjunction with other methods of assessing a treatment's abuse potential.
随着处方药物的非治疗性使用不断升级，与之相关的严重后果也有所增加。因此，准确评估处方药在研发和上市后不良事件监测中的误用、滥用和相关事件（MARE）至关重要。然而，用于描述处方药物 MARE 的分类和定义因分类系统的目的而异，可能适用于单一事件或持续的不当使用模式，且未标准化或系统地使用，从而使充分评估 MARE 发生的能力变得复杂。在对现有共识性努力、综述文章以及主要机构和代理机构的处方药物 MARE 术语和定义进行系统审查后发现，MARE 术语的定义常常不一致或因人而异，或者与其他 MARE 术语的定义重叠。Analgesic、Anesthetic、and Addiction Clinical Trials、Translations、Innovations、Opportunities、and Networks（ACTTION）公私合作伙伴关系召集了一个专家小组，以制定相互排斥和详尽的共识性分类和定义，用于描述发生在镇痛药物临床试验中的 MARE，以提高临床试验中对其发生和流行的描述的准确性和一致性。拟议的 ACTION 分类和定义旨在作为裁决发生在镇痛临床试验和上市后不良事件监测中的 MARE 的系统的第一步，可与评估治疗药物滥用潜力的其他方法结合使用。
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