Impact of COVID-19 on Drug Shortages

一半的美国人使用至少一种处方药; 24%使用3种或更多。然而，美国的一些药物- 作为预防和治疗疾病基石的罐头都是国产的，大部分的药品， 在美国消费的产品是在外国工厂生产的。因此，药物供应链是全球性的，而且持续不断。 易受意外事件（如2019年冠状病毒大流行（COVID-19））影响而中断。Unantic 突发事件可能导致药物短缺和治疗中断。治疗中断一直伴随着- 病情恶化，住院时间增加，死亡。然而，对频率知之甚少 药物短缺导致治疗中断，随后对不良临床结果产生影响。这是 在长期护理和门诊环境中尤其如此，大多数药物短缺都发生在这些环境中。美国 和加拿大都面临供应链中断的风险，导致全球紧急情况下的药物短缺。Dur- 在这一流行病期间，两国都实施了政策，试图减轻药品短缺的影响。 然而，加拿大的政策通常更严格，实施得更早。这些政策可能会影响 药物供应链的不同之处在于可以比较政策的有效性。虽然毒品问题 短缺是众所周知的，在全球范围内，我们对药物短缺的影响的认识存在差距。 紧急情况这一差距很大，因为药物短缺的发生频率越来越高，而且流行- 需要开展基于结果的研究，为今后的药品短缺战略提供信息（例如，国内药品生产）。 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物短缺的药物供应链; [2]评估导致 美国和加拿大的治疗中断;]和3）确定药物短缺与 严重不良临床结局。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;医疗保健实践的改进），食品和药物管理局，以及美国立法， 是的。我们还将评估药品短缺对AHRQ优先群体（少数民族、无保险、农村、 市中心、老年人、妇女、患有多种慢性病的人）。我们建议进行人口普查- 基于研究，评估药品短缺的影响并确定患者、社区、供应链和 与药物短缺相关的药物特征。[The这项研究的预期成果包括及时 关于大流行期间药物短缺影响的证据，包括负面健康结果，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。由主要利益攸关方组成的专家小组 将有助于传播，并根据我们的结果确定有效短缺政策的建议。 长期目标是为未来的全球紧急情况和药品短缺制定计划，并向各国提供信息， 和国际政策，以减少药物短缺对患者结果的影响。

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.]