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Medication Shortages: A Matter of National Security—Time for Action

      To the Editor:
      As noted by Choo and Rajkumar
      • Choo E.K.
      • Rajkumar S.V.
      Medication shortages during the COVID-19 crisis: what we must do.
      in the June 2020 issue of Mayo Clinic Proceedings, the COVID-19 (coronavirus disease 19) pandemic has exposed extreme vulnerabilities in our nation’s drug supply chain. The fragility of the drug supply chain was not created overnight and has been brewing for over a decade. Frequent generic drug shortages and quality deficiencies are compromising standard of care, producing waste, and increasing costs. For example, antibiotic shortages contribute to resistance, when clinicians are forced to use broad-spectrum agents. Today, 80% of active product ingredient (API) manufacturers are located overseas,
      FDA at a glance, April 2017. US Food and Drug Administration website.
      with the majority being obtained from India and China. India, a large manufacturer of finished products, obtains 70% of APIs from China.
      • Chatterjee P.
      Indian pharma threatened by COVID-19 shutdowns in China.
      China has a virtual monopoly on the APIs required to make critical drugs such as antibiotics, antihypertensives, and many others. Although the United States remains a global leader in drug discovery, we have almost completely transitioned manufacturing abilities to overseas because of lower production and labor costs. The United States’ overreliance on importing APIs from overseas has created a devastating impact on our public health with a potential for catastrophic events in the event of a war, trade conflict, or pandemic such as COVID-19 and impacting our national security. As expected, the United States is waiting in line with every other country for essential drugs during the current pandemic.
      Although there are no easy or fast solutions to this problem, we must act now. In addition to Choo and Rajkumar’s recommendations, the following steps may be considered with the ultimate goal of domestic manufacturing of most of the essential lifesaving drugs to protect our patients from harm.
      • Designate the pharmaceutical industry as a high-priority infrastructure critical to national security (like the aviation and energy sectors) to allow the federal government to coordinate efforts during shortages or national crises.
      • Develop an essential national security drug supply list that includes medications for which a supply interruption could cause an immediate risk to public health.
      • Create a national agency to monitor, plan, and identify potential manufacturers in the event of a shortage.
      • Manufacture products in multiple locations to protect the supply chain in the event of a natural disaster or other threats.
      • Strengthen federal oversight of manufacturers to ensure the highest product integrity and require manufacturers to provide transparency related to source of APIs and quality issues.
      • Develop a partnership between the private and public sectors acting as a united cohort to uncover incentives to drive actions to ensure domestic production of essential drugs.
      • Require manufacturers to report to the US Food and Drug Administration (FDA) immediately on discovery of an interruption, disclosing the reason and the expected time to resolution.
      • Create a national database for tracking of essential drug supplies and use predictive analytics to identify surge, production problems, and future shortages.
      • Allow outsourced 503B compounders to prepare drugs in short supply.
      • Allow the FDA to prioritize and expedite generic drug approvals.
      • Provide adequate FDA resources to allow frequent inspection of overseas facilities to ensure product integrity and quality.

      Appendix

      Editor’s Note: When publishing a letter that comments on an article published previously in Mayo Clinic Proceedings, it is the journal’s policy to invite the author(s) of the referenced article to publish a response. Drs Choo and Rajkumar were fully supportive of the letter by Guharoy and did not feel any response from them was necessary.

      References

        • Choo E.K.
        • Rajkumar S.V.
        Medication shortages during the COVID-19 crisis: what we must do.
        Mayo Clin Proc. 2020; 95: 1112-1115
      1. FDA at a glance, April 2017. US Food and Drug Administration website.
        https://www.fda.gov/media/104402/download
        Date accessed: April 17, 2020
        • Chatterjee P.
        Indian pharma threatened by COVID-19 shutdowns in China.
        Lancet. 2020; 395: 675

      Linked Article

      • Medication Shortages During the COVID-19 Crisis: What We Must Do
        Mayo Clinic ProceedingsVol. 95Issue 6
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          As of April 12, 2020, the Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome (SARS)–CoV-2 virus has affected more than 550,000 Americans, and claimed more than 21,000 lives.1,2 In just 2 months, the number of deaths is projected to reach over 60,000 — despite current levels of social distancing and other preventive measures.3,4 Health care workers are placing their lives at risk, and are facing enormous physical and emotional stress. The shortage of testing, masks, other personal protective equipment, and ventilators threatens to make our predicament worse.
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