Clinical Development and Medical Science, Endo Pharmaceuticals Inc., 1400 Atwater Drive, Malvern, PA 19355, USA.
Clin Drug Investig. 2013 Jul;33(7):459-68. doi: 10.1007/s40261-013-0087-8.
Opioids are an established therapy for cancer pain and have become an accepted therapy for chronic noncancer pain. However, increased prescribing of opioids in recent years has been accompanied by an increase in prescription opioid abuse. All opioids have inherent potential for abuse, but gaps in healthcare provider understanding of or adherence to best prescribing practices may facilitate the misdirection of opioids for abuse. To address these concerns, the US Food and Drug Administration has required pharmaceutical manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for prescribers of extended-release/long-acting (ER/LA) opioids and has encouraged research to develop opioid formulations that are less easily abused or less attractive for abuse. The ER/LA opioid REMS require a partnership between the pharmaceutical industry, regulators, and healthcare providers to develop educational materials for physicians and patients that are not promotional. This article addresses challenges associated with improving the quality of pain care through support of prescriber education, developing formulations that combine efficacy with tamper-resistant properties, and encouraging collaborative efforts by regulatory bodies, legislators, healthcare providers, and patient advocacy groups to achieve these ends.
阿片类药物是癌症疼痛治疗的既定方法，也已成为慢性非癌症疼痛的公认治疗方法。然而，近年来阿片类药物的处方量增加，同时也出现了阿片类药物滥用的增加。所有阿片类药物都具有滥用的固有潜力，但医疗保健提供者对最佳处方实践的理解或遵守方面存在差距，可能会导致阿片类药物被滥用。为了解决这些问题，美国食品和药物管理局已要求制药商为延长释放/长效（ER/LA）阿片类药物的处方者制定风险评估和缓解策略（REMS），并鼓励研究开发不易滥用或对滥用吸引力较低的阿片类药物制剂。ER/LA 阿片类药物 REMS 需要制药业、监管机构和医疗保健提供者之间的合作，为医生和患者开发非促销性的教育材料。本文讨论了通过支持处方者教育、开发将疗效与防篡改特性相结合的制剂以及鼓励监管机构、立法者、医疗保健提供者和患者权益组织之间的合作来提高疼痛治疗质量的挑战，以实现这些目标。
