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在《药物辅助治疗法案》实施背景下解决丁丙诺啡瓶颈问题:一项共同责任。

Addressing buprenorphine bottlenecks in the context of MAT Act implementation: A shared responsibility.

作者信息

Ostrach Bayla, Hill Lucas, Carpenter Delesha, Pollini Robin

出版信息

J Am Pharm Assoc (2003). 2023 Jul-Aug;63(4):1044-1048. doi: 10.1016/j.japh.2023.04.029. Epub 2023 May 4.

DOI:10.1016/j.japh.2023.04.029
PMID:37149144
Abstract

Medications for opioid use disorder (OUD) such as buprenorphine reduce overdose mortality and other opioid related acute health events but have historically been highly regulated. The recent Mainstreaming Addiction Treatment (MAT) Act ended the requirement clinicians complete a specified training and apply for a DATA 2000 ("X") waiver on their Drug Enforcement Administration (DEA) number, to prescribe buprenorphine. With the MAT Act, any practitioner with Schedule III prescribing authority (a regular DEA number) can now prescribe buprenorphine for OUD. While this has potential to improve OUD treatment access, the impact will depend on implementation. Though the MAT Act may facilitate increased buprenorphine prescribing, ensuring adequate buprenorphine dispensing is also critical to improving Medications for opioid use disorder. Recognized buprenorphine bottlenecks arise from a complex convergence of factors in community pharmacies, threatening to undercut the benefits of the MAT Act. If prescribing increases but is not matched by increased dispensing, bottlenecks may worsen. Any worsening of buprenorphine bottlenecks could have a disproportionate impact in rural areas where residents may rely on fewer pharmacies to fill prescriptions for people in larger geographic area and where larger prescribing-dispensing gaps already exist such as in Southern states. Rigorous research will be needed to document the overall impact of the MAT Act on community pharmacists and their patients. At the federal level, pharmacists and their professional organizations should lobby the DEA to de-schedule or re-schedule buprenorphine. The DEA should announce a moratorium on enforcement actions against wholesalers and pharmacies related to buprenorphine distribution and dispensing. More supports should be offered to community pharmacies by state pharmacy boards and associations including continuing pharmacy education and technical assistance for advocating with wholesalers to increase buprenorphine order sizes, and to more effectively communicate with prescribers. Pharmacies should not have to face these challenges alone. Regulators, wholesalers, and researchers must join together with community pharmacies to further reduce regulatory barriers to dispensing, provide evidence-based interventions where needed to support pharmacy dispensing efforts, conduct rigorous implementation research, and be constantly vigilant in identifying and addressing multi-level buprenorphine bottlenecks in the wake of the MAT Act.

摘要

用于治疗阿片类药物使用障碍(OUD)的药物,如丁丙诺啡,可降低过量用药死亡率及其他与阿片类药物相关的急性健康事件,但在历史上一直受到严格监管。最近的《成瘾治疗主流化(MAT)法案》取消了临床医生完成特定培训并申请以其药品执法管理局(DEA)编号的DATA 2000(“X”)豁免才能开具丁丙诺啡的要求。根据《MAT法案》,任何拥有III类处方权(普通DEA编号)的从业者现在都可以为阿片类药物使用障碍开具丁丙诺啡。虽然这有可能改善阿片类药物使用障碍的治疗可及性,但其影响将取决于实施情况。尽管《MAT法案》可能有助于增加丁丙诺啡的处方量,但确保足够的丁丙诺啡配药对于改善阿片类药物使用障碍的治疗也至关重要。社区药房中多种因素复杂交汇导致了公认的丁丙诺啡供应瓶颈,这可能会削弱《MAT法案》带来的益处。如果处方量增加但配药量没有相应增加,瓶颈可能会恶化。丁丙诺啡瓶颈的任何恶化对农村地区可能产生不成比例的影响,在这些地区,居民可能依赖较少的药房为更大地理区域内的人配药,而且已经存在较大的处方 - 配药差距,比如在南部各州。需要进行严谨的研究来记录《MAT法案》对社区药剂师及其患者的总体影响。在联邦层面,药剂师及其专业组织应游说药品执法管理局对丁丙诺啡进行重新分类或调整分类。药品执法管理局应宣布暂停对与丁丙诺啡分销和配药相关的批发商和药房采取执法行动。州药房委员会和协会应向社区药房提供更多支持,包括持续药学教育以及为倡导批发商增加丁丙诺啡订单量并更有效地与开处方者沟通提供技术援助。药房不应独自面对这些挑战。监管机构、批发商和研究人员必须与社区药房携手合作,进一步减少配药的监管障碍,在需要时提供基于证据的干预措施以支持药房配药工作,开展严谨的实施研究,并在《MAT法案》实施后持续警惕地识别和解决多层次的丁丙诺啡瓶颈问题。

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