The Centers for Disease Control and Prevention (CDC) established the Strategic National Stockpile (SNS)—at the time known as the National Pharmaceutical Stockpile—in 1999, with a focus on procuring and managing medical countermeasures (MCMs) designed to address chemical, biological, radiological, and nuclear (CBRN) events and attacks by weapons of mass destruction (WMDs). The stockpile is a repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel organized to respond to a spectrum of public health threats. Over time, the mission of the SNS has informally evolved to address other large-scale catastrophes, such as hurricanes or outbreaks of pandemic disease, and rare acute events, such as earthquakes or terror attacks. All of these events threaten to overwhelm local capacities to provide life-saving medications and medical supplies. When disaster strikes, states can request deployment of SNS assets to augment resources available to state, local, tribal, or territorial public health agencies. CDC works with federal, state, and local health officials to identify and address their specific needs and, according to the stated mission of the SNS, ensure that the right resources reach the right place at the right time (CDC, 2017).
The stockpile’s multibillion-dollar inventory is managed within CDC’s
1 The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.
Office of Public Health Preparedness and Response (OPHPR) by the Division of Strategic National Stockpile (DSNS), which includes approximately 200 federal and contract employees. CDC collaborates with several other federal agencies engaged in the provision of MCMs for public health emergencies through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).2
In 2015, the National Academies of Sciences, Engineering, and Medicine established a standing committee to help inform decision making by DSNS by providing a venue for the exchange of ideas among federal, state, and local governmental agencies, the private sector, and the academic community, as well as other relevant stakeholders involved in emergency preparedness and emergency response services. SNS Standing Committee members have included state and local public health officials, representatives of medical manufacturing and distribution companies, logistics managers, representatives of emergency medical services and emergency medicine practitioners, and experts in relevant fields, such as risk modeling and Food and Drug Administration (FDA) regulatory issues.
The Standing Committee for CDC’s Division of Strategic National Stockpile met seven times and conducted two public workshops between June 2015 and August 2017.3 The first workshop, held in February 2016, encompassed three broad areas of interest: increasing SNS efficiency and ensuring adequate distribution of its assets during crises; developing a risk-based approach to the SNS inventory; and evaluating the mission of the SNS, which has expanded from its initial focus on CBRN attacks to addressing naturally occurring emerging infections (e.g., Zika and Ebola) and disasters (e.g., earthquakes and floods) (NASEM, 2016). Workshop
2 As noted in the summary of the SNS Standing Committee’s previous workshop (NASEM, 2016), PHEMCE, led by the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), “was created to coordinate the efforts of the numerous federal agencies that have roles in optimizing public health emergency preparedness with respect to the creation, stockpiling, and use of medical countermeasures (MCMs). PHEMCE’s primary responsibilities are three-fold: defining and prioritizing requirements for public health emergency MCMs; focusing research, development, and procurement activities on the identified requirements; and establishing deployment and use strategies for the MCMs in the SNS. Key players among PHEMCE’s interagency efforts include the ASPR (which leads PHEMCE), The Biomedical Advanced Research and Development Authority (BARDA, a component of ASPR), CDC (which houses the SNS), the National Institutes of Health, the Food and Drug Administration (FDA), the Department of Defense (DoD), and the Department of Homeland Security (DHS).”
3 See http://nationalacademies.org/hmd/Activities/PublicHealth/Stockpile.aspx (accessed December 8, 2017).
presentations and discussion revealed the critical role of the global medical supply chain in addressing all three challenges, as well as its complexity and vulnerability. These discussions continued in subsequent meetings of the Standing Committee, who concluded that the global medical supply chain merited additional attention at their second public workshop.
The Standing Committee has also supported efforts by DSNS to define and implement a comprehensive communications strategy encompassing the broad spectrum of stakeholders in SNS operations, including policy makers, private-sector partners, public health officials, clinicians, and the general public. Thus, their second public workshop, convened on August 28, 2017, at the National Academy of Sciences building in Washington, DC, explored the current state of the global medical supply chain as it relates to SNS assets, and the role of communications in mitigating supply chain risks and in enhancing the resilience of MCM distribution efforts (see Box 1-1, Workshop Statement of Task). This workshop concluded the SNS Standing Committee’s activities and is summarized in this publication.
In his opening remarks to the workshop, DSNS director Greg Burel described how consultation with the Standing Committee had influenced his staff to build useful partnerships with the private sector and various organizations representing SNS stakeholders. He made particular note of DSNS’s work with the Healthcare Industry Distributors Association (HIDA), including tabletop exercises that brought his staff together with HIDA members. Those experiences offered insights into the role of the private sector in the supply chain on which DSNS relies to procure and distribute MCMs, and highlighted critical weaknesses and potential gaps in that chain. DSNS and HIDA are developing a playbook to ensure supply chain security for assets critical to a broad spectrum of emergency responses, he stated.
Burel anticipated that the current workshop would extend such discussions by identifying additional threats to the medical supply chain relevant to the SNS, as well as ways to ensure supply chain security. These objectives—as well as improving the overall effectiveness of the emergency response—can be furthered by increasing understanding and awareness of the SNS among its many stakeholders, he observed—thus the workshop’s two-fold emphasis on supply chain and strategic communications. As the Standing Committee’s formal activities reached their conclusion, Burel expressed hope that conversation between DSNS and committee members would continue. “We’ve got to figure out a way to keep talking to each other, and we’ll do that,” he declared.
As described in the Statement of Task (see Box 1-1), this workshop was intended to present a broad overview of vulnerabilities across the global medical supply chain—ranging from the provision of raw materials to the distribution of life-saving medicines to patients—and to highlight oppor-
tunities to address these risks. Participants also considered such relevant issues as the impact of supply and demand expectations on the availability of SNS assets during an emergency event, ways to facilitate altered standards of care necessary during an emergency, and the role of communications in managing reaction to and improving compliance with emergency health care measures.
The workshop took place in the shadow of Hurricane Harvey, which 3 days before had made landfall along the South Texas coast. The storm then stalled for several days, producing catastrophic flooding of record-setting proportions (NWS, 2017). “Harvey is bringing home the reality of the kind of issues that we’ve been discussing for 2 years,” noted SNS Standing Committee chair Tara O’Toole, senior fellow and executive vice president, In-Q-Tel.
Burel reported that DSNS was deeply engaged in the response to Harvey, with resources staged for deployment on request by the state for federal assistance and members of his staff assisting response teams from the Department of Health and Human Services (HHS). As predictions for the storm’s impact became increasingly dire, Burel said he had received emails and calls from HIDA-associated partners assuring him that they were prepared to move materiel as needed to support the SNS emergency response.
Setting the immediate context for the workshop, O’Toole reviewed observations from 2 years of discussion among members of the Standing Committee—personal views, she acknowledged, but which she believes are widely shared. She noted that the SNS has been exhaustively reviewed, audited, and reported on, reflecting its high value and numerous stakeholders.
“It turns out that the stockpile is actually fairly well managed,” O’Toole observed. Several reviews have made limited recommendations, such as increased funding for live drills and information technology, she noted. However, she added, few have accurately characterized the role of the SNS within a complex system of systems by which medical supplies—nearly all of which are manufactured overseas—are distributed along the competitive, for-profit, global medical supply chain. In the case of SNS assets, this chain extends to the delivery of MCMs from state health departments to people who need them, the so-called last mile. That final step, she said, “involves an equally complex concatenation of [nearly] 3,000 state and local health departments in this country (ASTHO, 2018), more than 5,000 hospitals (AHA, 2018), [and] hundreds of thousands of individual providers.”
This system’s breadth and complexity makes it—and by association, the SNS—vulnerable to disruption. Workshop presentations and discussion explored gaps in the supply chain from two points of view: first, from the
perspective of players in the commercial medical supply chain, and second, from the perspective of public health practitioners and clinicians involved in emergency response.
Public health officials and health care providers at the state and local levels “have a humongous job trying to dispense the SNS products once they come,” O’Toole stated, including location-specific challenges that cannot be resolved with generalized solutions. Because it is widely acknowledged that state health departments lack the resources needed to conduct drills to prepare for emergency events, she said, CDC “has been struggling to come up with some way of measuring capability and keep the state and local health departments moving forward without unduly burdening them or asking for the impossible.” With Hurricane Harvey acting as a testament to the variety of events for which the SNS and its state and local partners must be prepared to fulfill its mission—partners including but not limited to health departments, hospitals, clinicians, and caregivers—she urged workshop participants to discuss gaps in the medical supply chain.