The Security of America's Medical Product Supply Chain Considerations for Critical Drugs and Devices: Proceedings of a Workshop—in Brief (2021) / Chapter Skim
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The Security of America's Medical Product Supply Chain: Considerations for Critical Drugs and Devices: Proceedings of a Workshop - in Brief
The Security of America's Medical Product Supply Chain: Considerations for Critical Drugs and Devices: Proceedings of a Workshop - in Brief
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dependence on critical drugs and devices sourced or manufactured outside of the United States and provide recommendations to improve the resilience and address the vulnerabilities of the medical supply chain. On December 1 and 2, 2020, the Committee on Security of America's Medical Product Supply Chain held a 2-day virtual public workshop focused on assessing lists of critical and essential medical products.2 The committee sought to conceptually explore how critical and essential medical product lists are developed and used in practice.
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Schondelmeyer, co-principal investigator of the Resilient Drug Supply Project at the Center for Infectious Disease Research and Policy (CIDRAP) , University of Minnesota, stated that this project aims to establish a drug supply, shortage, and tracking framework and build a real-time platform to monitor, predict, and prevent critical supply failures.3 Since 2018, CIDRAP has been compiling lists of critical acute and chronic drugs (described in the next section)
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; and Pernette Bourdillion Esteve, team lead, Incidents and Substandard/Falsified Medical Products, WHO. The lists presented by the panelists prioritized critical and essential medical products and involved identifying the acute and chronic drugs that would have the most severe impact on patients if unavailable.
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acute medical centers and that are used to stabilize patients with those medical conditions rather than to manage longer-term chronic conditions. Throckmorton added that the essential medicines list is focused on those medical needs that are most likely to occur in a public health emergency.
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Given that most medical conditions are chronic, the project is now developing a Critical Chronic Drug List, which is expected to include around 500 molecules that "when medically needed in chronic care, must be available and used within a few days or weeks of the need, and on a regular basis, or the patient will suffer serious outcomes which may include debilitating disease progression and worsening health status resulting in emergency care, hospitalization, or death."10 For example, insulin would qualify. Hedman explained that WHO's Interagency Emergency Health Kit11 is a product list and packed-ready inventory, shared across United Nations agencies and implementing partners, that contains supplies to treat 10,000 people for 3 months during large-scale emergencies.
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Panelists included Heather Wall, chief commercial officer, Civica; Dan Kistner, group senior vice president of pharmacy service, Vizient; Craig Kennedy, senior vice president, Global Supply Chain Management, Merck; Bill Murray, medical device specialist executive, Deloitte Consulting; and Nicole Lurie, strategic advisor to the CEO and response lead, Coalition for Epidemic Preparedness Innovations; senior lecturer, Harvard Medical School; and former Assistant Secretary for Preparedness and Response, HHS. The panelists noted that the concept of resiliency can be defined and operationalized in different ways (e.g., manufacturing redundancy; product quality; ability to make up for shortages whenever some part of a supply chain is disrupted while continuing to provide safe, quality care even under crisis standards)
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and maintains a several-month safety stock of essential medications for use by their partners if demand or supply fluctuates, with a high degree of transparency around its manufacturing supply chain. Kistner explained how Vizient, a health care performance improvement company supporting more than half of the nation's hospitals, responded to the unprecedented demand for certain products -- and potential embargos on pharmaceuticals or starting products -- during the COVID-19 pandemic.
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At the outset of the COVID-19 pandemic, the finished goods supply chain for critical medical products faced major challenges in handling demand surges, minimizing supply disruption, and sustaining operations while preserving workforce safety. He highlighted several strategies to mitigate disruptions and promote resilience in the medical device supply chain: avoiding single sourcing, managing supply risk, ensuring end-to-end transparency, segmenting inventory by critical need, and using a patient-centric approach to assess need and demand.
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Identifying critical medical products for pediatric care is complex, he said. It is challenging to define "child" for emergency management purposes, and lists of critical products for pediatric needs are context dependent across emergency scenarios and settings.
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CLOSING REMARKS In closing the workshop, Wallace Hopp, chair of the Committee on Security of America's Medical Product Supply Chain, thanked all of the speakers, noting that the presentations and discussions on critical drugs and devices generated a great deal of thought and dialogue and will be invaluable as the committee works to develop recommendations to enhance the resiliency of the medical supply chain going forward. He concluded that to develop a more resilient medical supply chain for times of crisis and beyond, lessons learned from the COVID-19 pandemic should be woven into the fabric of health care supply chains -- from manufacturing and distribution to clinical and operational practice -- because future events could create even more profound shortages of medical products.
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2021. The security of America's medical product supply chain: Considerations for critical drugs and devices: Proceedings of a workshop -- in brief.
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