Duensing Kathryn, Twillman Robert, Ziegler Stephen, Cepeda M Soledad, Kern David, Salas Maribel, Wedin Gregory
RKT Consulting, LLC, Lenexa, KS, USA.
Behavioral Health Section, Saint Luke's Health System, Kansas City, MO, USA.
J Pain Res. 2020 Oct 1;13:2431-2442. doi: 10.2147/JPR.S267448. eCollection 2020.
Opioid overdose deaths in the United States have climbed sharply over the past two decades. Simultaneously, increased awareness of inadequately treated chronic pain has resulted in increased opioid analgesic prescribing. The correlation between these two phenomena has led policymakers to posit that they are causally linked, and to implement policy changes supporting safe opioid prescribing.
To evaluate the impact of its Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program, the US Food and Drug Administration (FDA) requested the opioid manufacturers responsible for implementing that program provide information regarding opioid policy changes from 2016 to 2018. FDA also requested a survey of state requirements for pain and opioid prescribing continuing education (CE), the number of prescribers affected by those requirements, the extent to which a REMS-compliant CE program would meet each state's requirements, and the number of relevant CE programs available.
Results indicate that 527 federal and state opioid-related policies (statutes, rules/regulations, and guidelines) were approved during the 2016-2018 study period. While the largest number of these policies focused on prescription drug monitoring programs, 170 specifically imposed limits on opioid prescribing and an additional 35 specifically referred to, or incorporated, the Centers for Disease Control and Prevention opioid prescribing guideline. We also found that 46 states and the District of Columbia mandated some amount of pain or opioid prescribing CE for prescribers renewing their licenses. These mandates potentially affected as many as 1.7 million prescribers. In 69% of cases, a REMS-compliant CE program would fully meet the state mandates for various types of prescribers.
The severity and complexity of the problems of pain management and opioid overdose have led to large-scale intervention by policymakers. Assessing the impact of these changes is difficult, at best, but will be necessary if interventions are to be refined to increase their effectiveness.
在过去二十年中,美国阿片类药物过量致死人数急剧攀升。与此同时,人们对慢性疼痛治疗不足的认识不断提高,导致阿片类镇痛药的处方量增加。这两种现象之间的关联促使政策制定者认为它们存在因果关系,并实施支持安全阿片类药物处方的政策变革。
为评估其阿片类镇痛药风险评估与缓解策略(REMS)计划的影响,美国食品药品监督管理局(FDA)要求负责实施该计划的阿片类药物制造商提供2016年至2018年阿片类药物政策变化的相关信息。FDA还要求对各州疼痛和阿片类药物处方继续教育(CE)要求、受这些要求影响的开处方者数量、符合REMS要求的CE计划满足各州要求的程度以及可用的相关CE计划数量进行调查。
结果表明,在2016 - 2018年研究期间,共批准了527项联邦和州与阿片类药物相关的政策(法规、规则/条例和指南)。虽然这些政策中数量最多的集中在处方药监测计划上,但有170项专门对阿片类药物处方进行了限制,另有35项特别提及或纳入了疾病控制与预防中心的阿片类药物处方指南。我们还发现,46个州和哥伦比亚特区要求为更新执照的开处方者提供一定量的疼痛或阿片类药物处方CE。这些要求可能影响多达170万开处方者。在69%的情况下,符合REMS要求的CE计划将完全满足各州对各类开处方者的要求。
疼痛管理和阿片类药物过量问题的严重性和复杂性导致了政策制定者的大规模干预。评估这些变化的影响即便不是极其困难,至少也是颇具挑战的,但如果要优化干预措施以提高其有效性,则有必要进行评估。