Department of Clinical Pharmacy, School of Pharmacy, Taipei Medical University, Taipei, Taiwan.
College of Pharmacy, California Health Sciences University, Clovis, CA.
Pain Physician. 2017 Nov;20(7):E1003-E1023.
Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse.
We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice.
Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations.
Increasing trends of opioid abuse and misuse have been reported globally. There are 5 types of abuse-deterrent opioid products: physical chemical barrier, combined agonist/antagonist, sequestered aversive agent, prodrug, and novel delivery system. The advantages and disadvantages of the 5 options are discussed in this review. A total of 9 products with abuse-deterrent labels have been approved by the Food and Drug Administration (FDA). The rates of abuse, diversion, and overdose deaths of these new products are also discussed. A framework for collecting in-time data on the efficacy, benefit and risk ratio, and cost-effectiveness of these new products is suggested to facilitate their optimal use.
The present review did not utilize systematic review standards or meta-analytic techniques, given the large heterogeneity of data and outcomes reviewed.
ADFs provide an option for inhibiting the abuse or misuse of oral opioid products by hindering extraction of the active ingredient, preventing alternative routes of administration, or causing aversion. Their relatively high costs, uncertain insurance policies, and limited data on pharmacoeconomics warrant collaborative monitoring and assessment by government agencies, pharmaceutical manufacturers, and data analysis services to define their therapeutic role in the future.
Opioid abuse, abuse-deterrent formulations, ADF, post-marketing, FDA guidance, cost impact, abuse liking, physician attitude, generic abuse-deterrent formulation, clinical application.
滥用防御制剂（ADFs）代表了一种遏制阿片类药物滥用潜力的新策略。
我们旨在比较和对比当前临床实践中滥用防御阿片类药物产品的特点和应用。
在数据库（Pubmed Medline、国际药学文摘、Google Scholar）和官方报告中进行文献检索。筛选相关数据并组织成：1）阿片类药物滥用的流行病学，2）减少阿片类药物滥用的缓解策略，3）ADFs 的发展，和 4）这些制剂的临床经验。
全球范围内报告了阿片类药物滥用和误用的上升趋势。有 5 种滥用防御阿片类药物产品：物理化学屏障、联合激动剂/拮抗剂、隔离厌恶剂、前药和新型给药系统。本综述讨论了这 5 种选择的优缺点。共有 9 种具有滥用防御标签的产品已获得食品和药物管理局（FDA）的批准。还讨论了这些新产品的滥用、转移和过量死亡的比率。建议建立一个框架，及时收集这些新产品的疗效、效益和风险比以及成本效益的数据，以促进其最佳使用。
鉴于所审查的数据和结果存在很大的异质性，本综述未采用系统评价标准或荟萃分析技术。
ADFs 通过阻碍活性成分的提取、防止替代给药途径或引起厌恶，为抑制口服阿片类药物产品的滥用或误用提供了一种选择。它们相对较高的成本、不确定的保险政策以及关于药物经济学的数据有限，需要政府机构、制药制造商和数据分析服务进行协作监测和评估，以确定它们在未来的治疗作用。
阿片类药物滥用、滥用防御制剂、ADF、上市后、FDA 指南、成本影响、滥用喜好、医生态度、通用滥用防御制剂、临床应用。
