With the coronavirus disease 2019 (COVID-19) pandemic projected to be the largest mass casualty event in U.S. history, large-scale efforts are under way to contain the spread through social distancing and to divert resources to acute care. Before the first COVID-19 case in the United States, a different epidemic—the opioid crisis—was taking the lives of 130 Americans per day (1). Given that infection epidemics disproportionately affect socially marginalized persons with medical and psychiatric comorbid conditions—characteristics of those with opioid use disorder (OUD)—we are gravely concerned that COVID-19 will increase already catastrophic opioid overdose rates. Besides the threat of infection to persons with OUD, there is serious risk that system-level gains in expanding access to medication for OUD, conducting critical research, and exacting legal reparations against opioid manufacturers will all reverse. We call for urgent action to counteract these risks.

Treatment systems need to facilitate uninterrupted access to the most effective medications for OUD treatment: methadone and buprenorphine (2). Regarding methadone, federal agencies relaxed requirements for physical examinations and allowed extended medication supply for stable patients (3). We need to rapidly expand methadone delivery via mobile teams (for example, repurposed syringe service programs) for quarantined patients. Opioid treatment programs—federally regulated facilities that primarily dispense methadone—should increase use of buprenorphine because of its safer pharmacologic properties and formulations that can be dosed thrice weekly and monthly. Federal agencies should leverage funds from a recent settlement about misuse of regulatory procedures by a buprenorphine manufacturer (4) to address financial barriers to buprenorphine provided through opioid treatment programs.

Buprenorphine prescribers should be allowed and encouraged to engage in all phases of care—evaluation, initiation of therapy, and monitoring—via telemedicine when appropriate. The Drug Enforcement Administration recently took a significant step by permitting teleprescribing of buprenorphine if 2-way audiovisual communication between the prescriber and the patient is in place, allowing for telephone-only communication when needed (5). Given that patients may not have adequate data access plans, we recommend that funding be allocated to support data plans for teleprescribing visits for patients initiating or continuing buprenorphine (and methadone) treatment.. In-home initiation of buprenorphine is feasible and safe and is supported by new dose titration protocols that eliminate the need for opioid withdrawal (6).

We recommend several additional steps to ensure access to buprenorphine in preparation for shifts in prescribers' work duties or sick leave due to COVID-19 and potential treatment disruptions as patients move in and out of hospitals. The federal government should temporarily remove limits on the number of patients an individual prescriber may treat concurrently. At present, clinicians are limited in the number of patients for whom they can treat concurrently in their first year. For the near future, these limits should be removed. In addition, we recommend that federal, state, and local governments be funded to form and support networks of experienced buprenorphine prescribers to address the needs of local patients and providers. For instance, the mentors from the federally funded Prescriber Clinical Support System, and those identified through primary care, addiction medicine, and addiction psychiatry societies, could be rapidly expanded and authorized to temporarily support clinicians and potentially prescribe for patients in their region if usual prescribers are unavailable. As more patients with OUD are admitted to hospitals, these networks would be available to provide remote consultative services to help reduce length of stay. To help reduce emergency department and hospital crowding, federal training requirements for buprenorphine should be eliminated to allow emergency medicine and hospitalist clinicians without waivers to write buprenorphine prescriptions at discharge to provide enough medication for patients to become engaged in outpatient treatment. Federal and state agencies should ensure that skilled nursing facilities do not refuse patients receiving methadone or buprenorphine.

Beyond day-to-day OUD treatment, COVID-19 threatens to grind essential clinical research to a halt unless proactive steps are taken. During the past 2 years, Congress authorized approximately $1 billion in the HEAL (Helping to End Addiction Long-term) initiative. Much of this work is just starting. In 2019, HEAL funded approximately 375 projects in 41 states, including 4 states as part of the HEALing Communities Study testing a “community-engaged intervention designed to increase the adoption of an integrated set of evidence-based practices delivered across health care, behavioral health, justice, and other community-based settings” (7). With virtually all research involving face-to-face contact stopping, these results will be delayed and study viability will be threatened. The effect of the COVID-19 pandemic on scientific validity will also need to be considered as the crisis profoundly changes patients and treatment systems. At a minimum, the federal government will need to devise a mechanism to provide ongoing funding for all persons supported to conduct laboratory and clinical research, including those working on opioid-related projects, while projects' safety and scientific validity are considered.

Finally, before the COVID-19 pandemic, important strides had been made in compensating victims of opioid manufacturers' malfeasance. For example, in August 2019, the state of Oklahoma won a $572 million lawsuit against Johnson & Johnson, with the judge ruling that the company overstated the benefits and understated the risks of opioid products, thus violating the state's public nuisance laws (8). These monies will go to victims' families and help bolster Oklahoma's addiction treatment resources. Delays in court hearings could backlog 2000 similar lawsuits and significantly delay remuneration, which is especially damaging given the looming economic crisis in the United States. To provide much-needed funding in the midst of these 2 crises, we urge acceleration of cases nearing resolution, a prominent one being Purdue Pharma's bankruptcy case, resolution of which could mean more than $10 billion to families and addiction treatment agencies (9).

Persons with OUD are especially vulnerable to not only COVID-19 but also interruptions in life-saving treatment. The response to COVID-19 and the speed with which regulatory barriers are being reconsidered and removed should be translated to opioid-related clinical, research, and legal policy. Bold efforts are needed to reduce the adverse effect that COVID-19 will have on progress in addressing opioid-related morbidity and mortality. In the absence of such efforts, we risk more catastrophic effects from these colliding epidemics.

References

• 1. Centers for Disease Control and Prevention. America's drug overdose epidemic: data to action. Accessed at www.cdc.gov/injury/features/prescription-drug-overdose/index.html on 20 March 2020. Google Scholar
• 2. National Academies of Sciences, Engineering, and Medicine. Medications for Opioid Use Disorder Save Lives. National Academies Pr; 2019. doi:10.17226/25310 Google Scholar
• 3. Substance Abuse and Mental Health Services Administration. Opioid treatment program (OTP) guidance. Accessed at www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf on 22 March 2020. Google Scholar
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• 5. Drug Enforcement Administration. COVID-19 information page. Accessed at www.deadiversion.usdoj.gov/coronavirus.html on 22 March 2020. Google Scholar
• 6. Becker WC, Frank JW, Edens EL. Switching from high-dose, long-term opioids to buprenorphine: a case series. Ann Intern Med. 7 April 2020. [Epub ahead of print]. doi:10.7326/L19-0725 Google Scholar
• 7. National Institutes of Health. NIH funds $945 million in research to tackle the national opioid crisis through the NIH HEAL Initiative. Accessed at www.nih.gov/news-events/news-releases/nih-funds-945-million-research-tackle-national-opioid-crisis-through-nih-heal-initiative on 21 March 2020. Google Scholar
• 8. Hoffman J. Johnson & Johnson ordered to pay $572 million in landmark opioid trial. The New York Times. 26 August 2019. Accessed at www.nytimes.com/2019/08/26/health/oklahoma-opioids-johnson-and-johnson.html on 21 March 2020. Google Scholar
• 9. Hals T. U.S. bankruptcy judge warns states not to threaten potential Purdue Pharma settlement. Reuters. 18 March 2020. Accessed at www.reuters.com/article/purdue-pharma-bankruptcy/us-bankruptcy-judge-warns-states-not-to-threaten-potential-purdue-pharma-settlement-idUSL1N2BB3A9 on 21 March 2020. Google Scholar

This article was published at Annals.org on 2 April 2020.

中文翻译：

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当流行病发生冲突时：2019 年冠状病毒病 (COVID-19) 和阿片类药物危机。

由于 2019 年冠状病毒病 (COVID-19) 大流行预计将成为美国历史上最大的大规模伤亡事件，因此正在进行大规模的努力，以通过社会疏远来遏制传播并将资源转移到急症护理上。在美国出现首例 COVID-19 病例之前，另一种流行病——阿片类药物危机——每天夺走 130 名美国人的生命 (1)。鉴于感染流行不成比例地影响患有医疗和精神疾病的社会边缘人群——阿片类药物使用障碍 (OUD) 患者的特征——我们严重担心 COVID-19 会增加已经是灾难性的阿片类药物过量使用率。除了感染 OUD 患者的威胁之外，在扩大 OUD 药物的获取、开展关键研究、对阿片类药物制造商的严格法律赔偿将全部逆转。我们呼吁采取紧急行动来应对这些风险。

治疗系统需要促进不间断地获得最有效的 OUD 治疗药物：美沙酮和丁丙诺啡 (2)。关于美沙酮，联邦机构放宽了体检要求，并允许为病情稳定的患者提供更多的药物供应 (3)。我们需要通过流动团队（例如，重新调整用途的注射器服务计划）为被隔离的患者迅速扩大美沙酮的交付。阿片类药物治疗计划——主要分配美沙酮的联邦监管机构——应该增加丁丙诺啡的使用，因为丁丙诺啡更安全的药理特性和配方可以每周和每月给药三次。

应允许并鼓励丁丙诺啡处方者在适当时通过远程医疗参与护理的所有阶段——评估、开始治疗和监测。缉毒局最近迈出了重要的一步，如果开药者和患者之间进行了 2 向视听通信，则允许远程开处方丁丙诺啡，允许在需要时仅通过电话进行通信 (5)。鉴于患者可能没有足够的数据访问计划，我们建议分配资金以支持开始或继续丁丙诺啡（和美沙酮）治疗的患者远程处方访问的数据计划。通过消除阿片类药物戒断需要的新剂量滴定方案 (6)。

我们建议采取几个额外的步骤来确保获得丁丙诺啡，以准备因 COVID-19 而改变处方者的工作职责或病假，以及患者进出医院时可能出现的治疗中断。联邦政府应暂时取消对个人开药者可同时治疗的患者人数的限制。目前，临床医生在第一年可以同时治疗的患者数量有限。在不久的将来，这些限制应该被取消。此外，我们建议为联邦、州和地方政府提供资金，以形成和支持经验丰富的丁丙诺啡处方者网络，以满足当地患者和提供者的需求。例如，来自联邦政府资助的 Prescriber 临床支持系统的导师，那些通过初级保健、成瘾医学和成瘾精神病学协会确定的人，可以迅速扩大和授权，以临时支持临床医生，并可能在无法找到常用处方者的情况下为他们所在地区的患者开处方。随着越来越多的 OUD 患者入院，这些网络将可用于提供远程咨询服务，以帮助缩短住院时间。为帮助减少急诊科和医院的拥挤情况，应取消对丁丙诺啡的联邦培训要求，以允许急诊医学和住院临床医生无需豁免即可在出院时开具丁丙诺啡处方，为患者提供足够的药物以进行门诊治疗。

除了日常的 OUD 治疗之外，除非采取积极措施，否则 COVID-19 还可能使重要的临床研究陷入停顿。在过去的两年中，国会批准了大约 10 亿美元的 HEAL（帮助长期戒毒）倡议。大部分工作才刚刚开始。2019 年，HEAL 资助了 41 个州的大约 375 个项目，其中 4 个州作为 HEALing 社区研究的一部分，测试了“社区参与的干预措施，旨在增加在医疗保健、行为健康领域提供的一套综合循证实践的采用” 、正义和其他基于社区的环境”（7）。随着几乎所有涉及面对面接触的研究都停止，这些结果将被推迟，研究的可行性将受到威胁。随着危机深刻改变患者和治疗系统，还需要考虑 COVID-19 大流行对科学有效性的影响。联邦政府至少需要制定一种机制，为所有支持开展实验室和临床研究的人员提供持续资金，包括从事阿片类药物相关项目的人员，同时考虑项目的安全性和科学有效性。

最后，在 COVID-19 大流行之前，在对阿片类药物制造商的渎职行为的受害者进行赔偿方面取得了重要进展。例如，2019 年 8 月，俄克拉荷马州赢得了对强生公司 5.72 亿美元的诉讼，法官裁定该公司夸大了阿片类产品的好处并低估了阿片类药物的风险，从而违反了该州的公害法 (8)。这些款项将捐给受害者家属，并帮助增加俄克拉荷马州的戒毒治疗资源。法庭听证会的延迟可能会积压 2000 起类似的诉讼，并显着延迟支付报酬，鉴于美国迫在眉睫的经济危机，这尤其具有破坏性。为了在这两场危机中提供急需的资金，我们敦促加速接近解决的案件，其中一个突出的例子是普渡制药公司

患有 OUD 的人特别容易受到 COVID-19 和挽救生命治疗中断的影响。应对 COVID-19 以及重新考虑和消除监管障碍的速度应转化为与阿片类药物相关的临床、研究和法律政策。需要大胆努力减少 COVID-19 对解决阿片类药物相关发病率和死亡率进展的不利影响。如果没有这样的努力，我们将面临这些相互碰撞的流行病带来更多灾难性影响的风险。

参考

• 1. 疾病控制和预防中心。美国的药物过量流行：数据到行动。2020 年 3 月 20 日在 www.cdc.gov/injury/features/prescription-drug-overdose/index.html 上访问。Google Scholar
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本文于 2020 年 4 月 2 日在 Annals.org 上发表。