3

Studies and Reports Related to the Strategic National Stockpile

ANTICIPATED RESPONSIBILITIES OF THE SNS IN THE YEAR 2020

John Parker, former chair, National Biodefense Science Board (NBSB)¹ and report co-chair for Anticipated Responsibilities of the SNS in the Year 2020: An Examination with Recommendations, A Joint Report of the National Biodefense Science Board and the Office of Public Health Preparedness and Response Board of Scientific Counselors,² outlined the three tasks that the NBSB and Office of Public Health Preparedness and Response Board of Scientific Counselors (OPHPR BSC) were charged with by the Office of the Assistant Secretary of Preparedness and Response (ASPR) and the Centers for Disease Control and Prevention (CDC) director of the OPHPR:

1. To identify anticipated responsibilities of the Strategic National Stockpile (SNS) in the year 2020,
2. To recommend approaches for meeting those responsibilities as efficiently as possible, and
3. To propose metrics for reporting program capability and informing improvement.

___________________

¹ The National Biodefense Science Board was renamed in April 2014 to the National Preparedness and Response Science Board.

² See http://www.phe.gov/Preparedness/legal/boards/nprsb/recommendations/Documents/nbsb-bsc-sns-2020-final.pdf (accessed June 3, 2016).

The Joint SNS 2020 Working Group comprised members of the NBSB, the OPHPR BSC, and industry representatives.

Responses to Task 1, Parker reported, included the need to secure the public health of the United States and to augment the U.S. security posture. He commented that if “we don’t have a good secure public health policy, we can’t have any other type of security posture.” The next response is to maintain a cache of medical countermeasures (MCMs) and materiel necessary to support a robust response to the widest possible spectrum of public health emergencies. Next, because of the mutual and critical dependence existing between the SNS and state and local public health agencies, the SNS should be increasingly enhanced to meet public health responsibilities. The NBSB and the OPHPR BSC agreed that they did not foresee either a reduction in SNS responsibilities or a reduction in the cost of fulfilling these responsibilities because of continuing needs.

Parker explained that the response to the second task, recommending approaches for meeting responsibilities as efficiently as possible, called for an increased reliance on state-of-the-art risk management and applied science. Metrics proposed for reporting program capability and informing improvement in response to Task 3 include deriving program capability metrics from actual performance data (where such information exists), results of exercises, and computational modeling and simulations. The latter component was emphasized due to the expense of full-blown exercises. The program capability assessment metrics should identify not only gaps and strengths in distribution of MCMs, but also delivery to the public. The report stated that the SNS should carry out rigorous exercises of their current capabilities as part of a wholly integrated national response system (despite the expense, these are still necessary, particularly when dealing with staff on retainers). Finally, Parker noted that the report said performance assessments should be expanded to include the desired outcome: rapid delivery of critical countermeasures to the public. The report’s recommendations are listed in Box 3-1.

A NATIONAL BLUEPRINT FOR BIODEFENSE: LEADERSHIP AND MAJOR REFORM NEEDED TO OPTIMIZE EFFORTS

Ellen Carlin, co-director, Blue Ribbon Study Panel on Biodefense, and principal, Carlin Communications, presented on the report A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts.³ She explained that the self-prescribed mandate was broad, covering the four pillars of biodefense as outlined in Homeland Security

___________________

³ See http://www.biodefensestudy.org/SiteAssets/1425-2139_BRSP_Report_100815b[1][6].pdf (accessed June 3, 2016).

Presidential Directive 10, and the panel found that the federal government is carrying out many important activities in a siloed and uncoordinated manner in the absence of a single point of responsible leadership for biodefense or a national strategy that coheres all of the activities of its different departments and agencies.

Carlin described how the report is structured into three thematic areas of deficiency: interagency coordination, collaboration with stakeholders and innovation (particularly in areas of biodetection and biosurveillance), and MCM development. It contains 33 recommendations, of which she focused on the two primarily related to management of the SNS.

Carlin explained that Chapter 2 of the report focused on the need to elevate collaboration with the many SNS stakeholders across the country, with Section IV devoted to advancing planning for MCM distribution and dispensing. Carlin noted that while preparedness for distribution and dispensing has improved greatly over the past 10 years, there are still populations that will not be reached within the 48-hour window within the current system. She said that further challenges that persist within the MCM response architecture include lack of clear centralized leadership; lack of clear and consistent directives for coordination of state, local, territorial, and tribal plans; lack of clear goals and objectives for response; and insufficient funding for health departments.

The panel analyzed various modalities of distribution, such as the postal approach; Carlin contended that an optimal national mass prophylaxis capability would have to reach far beyond what the U.S. Postal Service could provide and into private delivery companies, pharmaceutical chains, and volunteer health care worker coalitions. Similarly, she suggested that dependence on the static open-point of dispensing (POD) model will not meet the need in a mass event. The panel ultimately concluded that national mass prophylaxis must depend on nonfederal input planning and implementation, with a national stakeholder-driven MCM response framework providing structure and guidance for local planning efforts.

Carlin commented that these deliberations led to Recommendation 22 (see Box 3-2), which calls for the development and implementation of an MCM response framework, coordinated by CDC, the ASPR, and the Federal Emergency Management Agency (FEMA) alongside nonfederal partners from states, localities, industries, and nongovernmental organizations.

Carlin highlighted the conclusion that national mass prophylaxis must depend on nonfederal input, planning, and implementation, with the recommended framework addressing parameters for federal commitments such as expectations at the state and local levels, the important issue of clinical utilization guidance (she noted that there are MCMs that were in the stockpile for years before they had clinical guidance published), and essential information sharing with nonfederal partners. Carlin also

emphasized the importance of Recommendation 23 (see Box 3-3), which calls for select forward deployment of SNS assets to localities that have a demonstrated ability to handle them appropriately.

PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE REVIEW: A STRATEGIC REPORT

Robert L. Burhans, senior executive, Tetra Tech, Emergency Management and Community Resilience, served as a special project advisor to the Association of State and Territorial Health Officials (ASTHO) report Public Health Emergency Medical Countermeasures Enterprise Review: A Strategic Report,⁴ completed in November 2013. The report was commissioned by ASTHO to better inform its membership about issues surrounding the country’s medical countermeasures enterprise. Burhans described three areas of focus that informed the review. The first focus area centered on actions to better integrate and involve the public health enterprise in the

___________________

⁴ A summary of the report’s findings are available at http://www.astho.org/Preparedness/DPHP-Materials-2013/PHEMCE (accessed June 3, 2016).

Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and specifically to engage in priority activities identified in the 2012 HHS PHEMCE Implementation Plan. The second centered on actions to further the implementation of Executive Order 13527, “Establishing Federal Capability for the Timely Provision of Medical Countermeasures Following a Biological Attack.” The third focus was on actions to enhance the effectiveness of MCM and Public Health Preparedness Program activities within ASTHO.

The review methodology included the identification, cataloging, and review of relevant documents and websites; individual interviews with federal officials, state and city directors of public health preparedness, ASTHO Preparedness Policy Committee members, and other key informants; review of source documents describing ASTHO’s current MCM portfolio; and the participation in meetings and conference calls conducted by ASTHO’s Directors of Public Health Preparedness Executive Committee and Emergency Medical Countermeasures Steering Committee.

Employing the methodology, according to Burhans, generated sig-

nificant evidence that the PHEMCE Strategy and Implementation Plan, particularly the federal inter- and intraagency organizational structure, had been successful in increasing collaboration and alignment among the federal agencies engaged in PHEMCE. Examples he cited included the Medical Countermeasures Initiative (MCMi), FDA’s initiative to organize around MCM development, approval, and use. This initiative demonstrates multilayered collaboration with internal FDA partners, external PHEMCE partners, and drug manufacturers to advance FDA’s PHEMCE activities. CDC and ASPR/Biomedical Advanced Research and Development Authority (BARDA) aligned their efforts to accomplish a stockpile of new botulinum and anthrax antitoxins identified by the implementation plan as top priorities.

Burhans summarized the review’s recommendations concerning PHEMCE’s organizational structure, noting that the report was directed to ASTHO, not to the PHEMCE agencies, and focused on what ASTHO should do to become more fully engaged in the PHEMCE organizational structure. The first recommendation was to work with ASPR to identify a point person to manage the public health emergency preparedness (PHEP) relationship with PHEMCE. To date, he noted, the strongest relationship that the public health enterprise has is with CDC because of relationships established over the years, grant activities through PHEP, and the fact that the public health enterprise relies on the SNS to provide its MCMs. Further recommendations were to discuss the optimal structure to engage the public health enterprise with the PHEMCE Enterprise Executive Committee at a strategic level, identify PHEMCE priority activities that require public health enterprise input, and meet with ASPR and the Department of Homeland Security (DHS) to address issues with the PHEMCE requirement-setting process.

Burhans emphasized that the public health enterprise (see Box 3-4), which has the responsibility for dispensing MCMs, needs to be engaged in the requirement-setting process because decisions on the formulary and the attributes of the MCMs absolutely dictate dispensing strategies. If the public health enterprise is not fully engaged in the requirement-setting process, then there is the potential for decisions to be made that may not fully reflect the concerns of those doing the dispensing.

The next set of recommendations from the ASTHO report relates to strategic issues identified in Executive Order 13527, which Burhans described as high-level objectives. The first recommendation is to work to communicate the U.S. Postal Service dispensing model to the public health enterprise and find ways to support law enforcement participation in the execution of that model, because having sufficient law enforcement capacity was determined to be a limiting factor in the actual use of that plan by many local and state health departments. The second, understanding and

communicating the federal rapid response plan to the public health enterprise, he described as essentially developing a concept of operations about how federal resources would be brought to bear to enhance local dispensing efforts. This also includes a federal continuity-of-operations plan, whereby essential personnel in federal agencies would be identified and provided with MCMs. The third is to identify and advance lessons learned from the first round of “big city” reviews, and the fourth is to engage FEMA in the routine assessment of state SNS planning.

Burhans outlined a final set of recommendations that were provided for ASTHO regarding how they could better organize their internal structures to be more effective:

• Identify an ASTHO staff member to be the primary PHEMCE liaison.

• Develop clear protocols for gaining the Directors of Public Health Preparedness (DPHP) endorsement of federal guidance.
• Assign the DPHP Executive Committee to vet emergency medical countermeasures (eMCMs) projects.
• Assign DPHP Executive Committee members as liaisons to the eMCM Planning Group.
• Include a National Association of County and City Health Officials (NACCHO) representative on the Preparedness Policy Committee.
• Increase collaboration between ASTHO and NACCHO on PHEMCE issues.

In helping wrap up the discussions, Burel reflected that during his 8-year tenure as director of the CDC Division of Strategic National Stockpile, the division has been the recipient of more than 120 reviews and audits that have benefited the program in numerous ways. It has developed increasingly stronger partnerships with other federal and nonfederal agencies that have been parlayed into better ability to respond to events such as Ebola. Burel has been invited to be part of the DoD Medical Logistics Senior Steering Council, for example, which he referred to as a forum for sharing topics of discussion that the SNS has with PHEMCE, as well as how the agencies can mutually support each other in health emergencies.

This page intentionally left blank.