Impact of COVID-19 on Drug Shortages

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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.]