Impact of COVID-19 on Drug Shortages

一半的美国人使用至少一种处方药；24%的人使用三种或更多处方药。然而，美国的药物很少- 作为预防和治疗疾病的基石的罐头是国内生产的；大多数本草- 在美国消费的饮料是在外国工厂生产的。因此，药品供应链是全球性的，而且是持续的。 易因意外事件造成中断，例如2019年冠状病毒大流行(新冠肺炎)。无厘头的- 假冒事件可能会导致药物短缺和治疗中断。治疗中断是相关联的- 病情恶化，住院人数增加，甚至死亡。然而，人们对这种频率知之甚少。 药物短缺造成治疗中断以及随后对不良临床结果的影响。这是 在长期护理和门诊环境中尤其如此，因为大多数药物短缺都发生在这些地方。美国 在全球紧急情况下，加拿大和加拿大都面临供应链中断导致药品短缺的风险。杜尔- 在大流行期间，两国都实施了政策，试图减轻药品短缺的影响。 然而，加拿大的政策总体上更严格，实施得更早。这些政策可能会影响 不同的药品供应链允许比较政策的有效性。虽然毒品问题 短缺是众所周知的，我们对全球药品短缺的影响的认识存在差距 紧急情况。这一差距是显著的，因为药品短缺正在以越来越频繁和流行的方式发生- 需要基于规则的研究来为未来的药物短缺战略(例如，国内药物生产)提供信息。 在初步数据的指导下，我们将追求3个具体目标：1)确定大流行如何影响 导致美国和加拿大药品短缺的药品供应链；[2]评估导致药品短缺的原因 美国和加拿大的治疗中断；]和3)确定药物短缺和 严重的不良临床后果。拟议的研究与AHRQ的研究优先领域保持一致 (更安全的医疗保健；改善医疗保健实践)，食品和药物管理局，以及美国立法机构- 提顿。我们还将评估药品短缺对AHRQ优先群体(少数民族、未参保、农村、 市中心、老年人、妇女、患有多种慢性病的人)。我们建议进行一次人口普查- 评估药品短缺的影响并确定患者、社区、供应链和 药品--与药品短缺有关的特征。[这项研究的预期结果包括及时 关于大流行期间药品短缺影响的证据，包括负面健康后果，特别是 在最脆弱的人群中。通过比较美国和加拿大的短缺情况，我们将确定 美国新立法和加拿大紧急政策的有效性。由主要利益相关者组成的专家小组 将帮助传播，并根据我们的结果确定关于有效短缺政策的建议。 长期目标是为未来的全球紧急情况、普遍的药品短缺制定计划，并向国家- 以及减少药品短缺对患者预后影响的国际政策。]

Half of all US persons use at least 1 prescription drug; 24% use 3 or more. However, few of the drugs Ameri- cans take as a cornerstone to prevent and treat disease are produced domestically; the majority of medica- tions consumed in the US are produced in foreign facilities. Thus, the drug supply chain is global and suscep- tible to disruption due to unanticipated events, such as the 2019 Coronavirus pandemic (COVID-19). Unantic- ipated events may lead to drug shortages and treatment disruption. Treatment disruption has been associ- ated with worsening illness, increased hospitalization, and death. However, little is known on the frequency of drug shortages causing treatment disruption and subsequent impact on adverse clinical outcomes. This is especially true in long-term care and outpatient settings, where the majority of drug shortages occur. The US and Canada are both at risk for supply chain disruption leading to drug shortages in a global emergency. Dur- ing the pandemic, both countries implemented policies in an attempt to lessen the impact of drug shortages. However, Canadian policy was generally more stringent and implemented earlier. These policies may impact the drug supply chain differently allowing for comparison of policy effectiveness. Although the problem of drug shortages is well known, there is a gap in our knowledge of the impact of drug shortages during a global emergency. This gap is significant because drug shortages are occurring with increasing frequency and pop- ulation-based research is needed to inform future drug shortage strategy (e.g, domestic drug production). Guided by preliminary data, we will be pursuing 3 specific aims: 1) Determine how the pandemic impacted the drug supply chain leading to drug shortages in the US and Canada; [2) Assess drug shortages leading to treatment disruption in the US and Canada;] and 3) Determine the association between drug shortages and serious adverse clinical outcomes. The proposed study is aligned with the research priority areas of AHRQ (safer health care; improvements in health care practice), the Food and Drug Administration, and US legisla- tion. We will also assess the impact of drug shortages in AHRQ priority groups (minorities, uninsured, rural, inner-city, elderly, women, persons with multiple chronic conditions). We propose to conduct a population- based study to assess the impact of drug shortages and identify patient-, community-, supply chain- and drug-characteristics associated with drug shortages. [The expected outcomes of this study include timely evidence on the impact of drug shortages during a pandemic, including negative health outcomes, particularly among the most vulnerable populations. By comparing shortages in the US and Canada, we will identify the effectiveness of new U.S. legislation and emergency Canadian policy. An expert panel of key stakeholders will aid in dissemination and identify recommendations on effective shortage policies based on our results. The long-term goal is to plan for future global emergencies, drug shortages at large, and inform national- and international-policy to decrease the impact of drug shortages on patient outcomes.]