Massachusetts College of Pharmacy and Health Sciences University, Boston, MA 02115, USA.
J Am Pharm Assoc (2003). 2013 Jan-Feb;53(1):e1-7. doi: 10.1331/JAPhA.2013.12025.
To provide an update on the recently approved class-wide risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids and to discuss the potential impact on pharmacy practice.
In mid-2011, the Food and Drug Administration notified drug manufacturers that a single, class-wide REMS would be required for ER and LA opioids. This regulation was the result of a multiyear process that incorporated input from government, drug manufacturers, medical associations, and other stakeholders.
The goal of the class-wide REMS for ER/LA opioids is to reduce addiction, unintentional overdose, and death resulting from inappropriate prescribing, misuse, and abuse. To accomplish these goals, this REMS focuses on physician education on safe and appropriate prescribing and patient counseling on the risks of opioids. Although voluntary, a movement to require physician education to obtain or renew Drug Enforcement Administration licensing is occurring. Pharmacists are not included in the class-wide REMS per se. Pharmacists play an important role in overall risk reduction and are critical to the success of the class-wide REMS.
Although the changing requirements for prescribing ER/LA opioids will not have a direct effect on pharmacist workflow, the pharmacist-patient interaction remains critical for overall risk reduction with this class of medication.
介绍最近批准的延长释放（ER）和长效（LA）阿片类药物的全类风险评估和缓解策略（REMS）的最新情况，并讨论其对药学实践的潜在影响。
2011 年年中，美国食品和药物管理局（FDA）通知药品制造商，ER 和 LA 类阿片类药物将需要单一的全类 REMS。这一规定是多年来整合政府、药品制造商、医学协会和其他利益相关者意见的结果。
ER/LA 类阿片类药物的全类 REMS 的目标是减少因不当处方、误用和滥用而导致的成瘾、意外过量和死亡。为了实现这些目标，该 REMS 侧重于医生的安全和适当处方教育以及患者对阿片类药物风险的咨询。虽然是自愿的，但正在出现一种要求医生接受教育以获得或更新美国缉毒局（DEA）许可证的趋势。药剂师本身并不包括在全类 REMS 中。药剂师在总体风险降低方面发挥着重要作用，对全类 REMS 的成功至关重要。
尽管 ER/LA 类阿片类药物的处方要求不断变化，不会直接影响药剂师的工作流程，但药剂师与患者的互动对于降低这类药物的总体风险仍然至关重要。
