Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction’s medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the state and local jurisdictions’ resources.
The Centers for Disease Control and Prevention’s (CDC’s) Strategic National Stockpile (SNS) is the nation’s repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel designed to supplement and resupply state and local public health agencies in the event of an emergency. The materiel is intended to support national health security and is managed by the Office of Public Health Preparedness and Response’s (OPHPR’s) Division of Strategic National Stockpile (DSNS). The stated mission of the SNS is to prepare and support partners and provide the right resources at the right time to secure the nation’s health.2
The SNS includes a multi-billion-dollar inventory that is managed to ensure that these supplies can be rapidly deployed as needed to support
1 The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs 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.
the response to a public health emergency. States may request federal assistance from CDC to deploy SNS assets, and CDC works with federal, state, and local health officials to determine what assets are needed during an emergency.
The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE),3 established by the Department of Health and Human Services (HHS) and led by 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 threefold: 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). The collaborative effort by these agencies provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
BARDA’s specific mission4 is to develop and procure MCMs that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Through its programmatic initiatives, BARDA supports the SNS by leading the advanced development and procurement of drugs, vaccines, and other products considered to be priorities for national health security.
The National Academies of Sciences, Engineering, and Medicine established a standing committee of experts to help inform decision making by CDC DSNS, including experts in state and local public health, MCM production, warehouse and product distribution, logistics management, emergency medical services, emergency medicine, risk communications, and FDA regulatory issues. The standing committee was established to provide a venue for the exchange of ideas among federal, state, and local
3 See https://www.medicalcountermeasures.gov/phemce.aspx (accessed April 15, 2016).
governmental agencies, the private sector, and the academic community, as well as other relevant stakeholders involved in emergency preparedness and emergency response services.
Tara O’Toole, chair of the SNS Standing Committee, and Senior Fellow and Executive Vice President, In-Q-Tel, explained that the SNS Standing Committee was asked by Stephen Redd, Director of CDC’s OPHPR, to investigate three areas of interest with respect to the complex enterprise of the SNS. The first area of focus concerned how to increase the efficiency of the SNS and ensure adequate distribution to the people in need during crises; this area is to be informed by lessons learned from past experiences and geared toward generating specific strategies for effective partnerships with the private sector and other federal agencies. The second request was to help CDC develop a risk-based approach to the inventory of the SNS, which currently holds approximately $7 billion5 in products across more than 900 separate line items, which are distributed across 6 large facilities in different locations (undisclosed for security reasons) throughout the United States. The third request was to reevaluate the focus of the SNS; since its inception in 1999, the emphasis has been on MCMs designed for potential CBRN attacks on the United States.
To best explore those ideas in the context of the workshop, O’Toole introduced a set of key questions to guide the discussions during the workshop in addition to the stated workshop objectives listed in the workshop statement of task (see Box 1-1):
- Should the SNS be used to treat diseases that are emerging naturally, such as the Zika virus?
- Should SNS contents be deployed internationally upon request?
- Should the SNS be used to shore up routine drug shortages that occur in the course of medical practice?
Each of these questions gives rise to further complex issues, noted O’Toole. For example, the use of the SNS to address routine drug shortages could jeopardize the central purpose of the stockpile, which is to be stocked and ready to be activated immediately when needed. She commented that the stockpile itself gives rise to its own set of questions and management complexities. PHEMCE is host to complicated DHS and HHS processes regarding how to decide what to put in the stockpile inventory. The back end, often referred to as the “last mile,” involves the actual dispensing of MCMs to the public after DSNS has delivered them to state- and local-level public health authorities, O’Toole noted. She commented that the declining federal budget is constraining front-end decisions about inventory, even
5 According to Greg Burel, director of DSNS, CDC.
as the threats are becoming very dynamic and impacting what should be included in the stockpile. Furthermore, O’Toole said budget constraints have had a devastating impact on state public health services, with CDC reporting that the number of state and local health officials has decreased by 50,000 since 2008.
Greg Burel, director of DSNS, commented that the stockpile has continued to expand its inventory even in the face of shrinking federal budgets. He pointed to the key concerns about the disposal and replacement of expiring pharmaceuticals as well as a formulary that is constantly evolving to adapt to new threats and new requirements. He also emphasized the importance of strengthening the dispensing system in the last mile by providing support and guidance to state and local public health officials. Burel explained that the SNS operates in as commercial a manner as possible in the sense that during large-scale events, it essentially becomes a very large distributor of particular products for a limited period of time. SNS is the distributor for emergency MCMs because it is optimized for emergency events outside of daily supply-chain operations. He characterized the SNS as acting on a day-to-day basis like a specialty distributor of products that are not available anywhere else; for instance, in certain circumstances the SNS can deploy an MCM on a one-off basis to an individual in need.
Ali Khan, dean of the College of Public Health, University of Nebraska Medical Center and former director, OPHPR, CDC, explained that the creation of the National Pharmaceutical Stockpile (later renamed the Strategic National Stockpile) at CDC was one of the critical components of the Chemical, Biological, Radiological and Nuclear Defense Program established in 1999, when a convergence of many factors led to an emergency appropriation to create a program to protect the nation’s health security. During his tenure as the director of OPHPR between 2010 and 2014, the value of the SNS inventory at that point increased by about 50 percent, from $4 billion to approximately $6 billion.
The key challenges Khan faced as director were insufficient resources to not only sustain the growth of the SNS, but also maintain the existing inventory. Resources were also needed to enable the necessary risk-informed decisions regarding the holdings and other management practices in order to ensure better CDC engagement, reinvigorate the PHEMCE process, and align the SNS efforts with the Public Health Emergency Preparedness Grant Program. CDC subject-matter experts were engaged with the PHEMCE process and managed by a medical officer; health care preparedness activities were moved to the SNS Division to better support health care and public health integration. An SNS 2020 Review was commissioned to institute a risk-based approach to make purchase decisions in conjunction with DHS in a way that integrated the best available intelligence information.
Khan offered three observations concerning the SNS based on his experiences. First, he emphasized that now is the time to revise the SNS mission and statute. The National Health Security Program (within which the SNS is situated) has evolved from a CBRN program to an all-hazards
program, meaning that natural disasters and pandemics are already part of its statute. He argued that the SNS needs to be more than a stockpiling program by focusing more on the last mile. That is, the SNS should not only deliver MCMs to local public health authorities, but also support local-level dispensation efforts, provide clinical guidance about the use of MCMs, and implement the appropriate systems to monitor treatment compliance during adverse events. He suggested that the SNS is ideally placed within CDC to perform these additional functions, which should be made explicit in authorizing language and should be budgeted separately by the SNS. He maintained that this authorization should also include a designation for international use of MCMs as well as the authority to sell or give away MCMs as appropriate for the program.
Khan’s second observation was that the SNS needs to continue to innovate. The Cities Readiness Initiative, the shelf-life extension program, and the use of vendor-managed inventory are examples of past successes in this regard, but there is still ample opportunity to increase engagement with industry. Khan’s final observation was that the current SNS model is not sustainable: the SNS cannot continue to buy MCMs for an ever-expanding list of material threats; it needs to integrate across these threats in conjunction with the PHEMCE and make critical decisions about what to buy and what not to buy given its resource constraints.
Daniel Sosin, deputy director and chief medical officer, OPHPR, CDC, reflected that as a capability designed for catastrophic events, the SNS has had no actual experience to draw upon over the past 17 years to inform how its future should look, yet the SNS has been engaged in everyday events over its entire history. CDC has successfully guided it through those missions and built a broader constituency of interest that has expanded the expectations of what the stockpile mission and role should be, but he noted that with a broader spectrum of partnerships come varied and increasing demands. The bottom line and key challenge he identified is that “the resources that American people are willing to commit to a Strategic National Stockpile are not sufficient to meet all of the expectations.” Without better focus, he contended, the SNS will not be able to fulfill the greatest amount of life-saving potential.
Sosin noted that the mission of the SNS has expanded over time to include, for example, response to natural disasters and operation of federal medical stations for displaced populations. During the responses to Hurricane Katrina, the H1N1 pandemic flu, and Ebola, the DSNS helped to guide the existing medical supply chain in the provision of medications and equipment. He suggested that this role has the potential to help leverage existing supply-chain infrastructure to bring efficiencies to the work of the stockpile.
The “last mile” issue has come to prominence over the past 5 years, commented Sosin, as evidenced by the spotlight of attention on state- and local-level public health response capacity for mass dispensing of oral MCMs. Sosin also pointed to the SNS’s critical role in sustaining upstream investment in research, development, and production of MCMs for non-routine conditions that thus lack enabling market forces: “That commitment to sustaining the investments in producing these medical countermeasures strains and constrains the ability of the Strategic National Stockpile to address the areas of greatest risk.” Over the past 17 years, Sosin reported, fiscal and performance audits of the SNS have demonstrated good fiscal responsibility and stewardship of resources, but this is impeded by the constraints of insufficient resources and the expanding SNS mission.
Sosin called for the urgent need “to bring a scientific perspective, going beyond a performance audit and helping us match the resources that are realistic to expect for an SNS and put that against the potential to reduce the greatest amount of risk.” Building a sustainable SNS to achieve these important roles will require prudent selection of targets, ensuring that the material and the capability built at the national level will be able to deliver effectively to the individual at the local level.
Sally Phillips, deputy assistant secretary for policy, ASPR, HHS, reflected on the sustainability of the SNS and how investments are being made, noting that sustainability requires taking into consideration not only the amount of resources that go into procuring a stockpile, but also the costs involved in developing, procuring, storing, and deploying the stockpile, which are only a small fraction of the network of the stockpile’s contributions. Challenges layered on top of the stockpile’s demands are ensuring that MCMs can be received by a sufficient number of trained providers ready to accept and dispense those MCMs at the point of dispensing (POD) level. She advised that tails on the stockpile—including clinical guidance, diagnostics, treatment modalities, and the health care system’s response capacity—must feed into modeling and considerations of cost. Reaching the last mile is a critical concern: “the operational challenges of the stockpile are as intense as the early upfront investments in procuring.”
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