The Nation's Medical Countermeasure Stockpile Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary (2016) / Chapter Skim
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4 Potential Opportunities for Restructuring Strategic National Stockpile Scope, Governance, and Decision Making
4 Potential Opportunities for Restructuring Strategic National Stockpile Scope, Governance, and Decision Making
Pages 41-54
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From page 41... ...
is improving, commending its financial accountability mechanisms, inventory control, security systems, low administrative costs, business practices, number of products developed through the Biomedical Advanced Research and Development Authority (BARDA) , its decision and review processes, and its regulatory interactions.
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From page 42... ...
Carlin cautioned about a nearterm funding issue as products transition from Project BioShield to the SNS, noting that Congress has been informed but will likely still be surprised with the cost of the SNS moving forward. However, because the standing committee mandate came from Congress, it provides a platform to speak to Congress directly and make realistic budget requests.
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From page 43... ...
Given that most shortages result from decisions made at the supplier and marketing levels, SNS involvement could actually extend the length of the shortage, when prices are suppressed by the additional supplies and the financial incentives for resolving the shortages in the field are removed. Michael Poole, SNS coordinator, Texas Department of State Health Services, noted that CDC is almost already doing this, for example, with CHEMPAK and the nursing home shortages of Tamiflu.
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She noted that the Public Health Emer gency Medical Countermeasures Enterprise (PHEMCE) probably considers this privately in the context of consequence modeling and dosages, distribution, and dispensing.
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Burhans suggested an integrated, unified budgeting process among all agencies participating in PHEMCE, the SNS itself, and those responsible for the last mile so that there are discrete appropriations for each activity that does not compete or conflict with each other, causing difficult decisions for directors about budgeting (e.g., lab equipment versus SNS drill)
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From page 46... ...
Sosin responded that public health consequences are risk as defined in the intelligence community context, imperfect though that may be. Qualitative input from the intelligence community contributes to understanding and modeling the intentions and plans of groups intending to do harm and how those agents might be disseminated in populations.
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From page 47... ...
Khan suggested that the SNS should also redefine its antibiotic holdings based on a portfolio that covers more microbes with fewer broad-spectrum drugs. He suggested that there are also things around margins that can help to deal with resource constraints; for instance, an effective solution to the problem of unsustainability could be for BARDA to assume a more powerful role, for example, by developing pathogen- or agent-independent therapeutics that target sepsis independent of bacterial or viral etiology.
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From page 48... ...
Rocco Casagrande, Managing Director, Gryphon Scientific Casagrande explained that the DHS Integrated CBRN Terrorism Risk Assess ment (ITRA) is a probabilistic risk assessment that incorporates intelligence data from the broader intelligence community on terrorists' preferences for targets and roots of acquisitions for various agents.
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From page 49... ...
Casagrande explained that the study methodology first employed the ITRA to generate several hundred biological and radiological attack scenarios that represent the risk of terrorism with these agents. The second phase also looked at chemical and nuclear attack scenarios, before looking at the CBRN space in total.
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From page 50... ...
The investigators made sure to capture that variety of uncertainty in what the terrorists might do or how luck or fortune might play in their favor or against them. Uncertainty in public health response was accounted for using three response capabilities: optimistic, average, and pessimistic (see Figure 4-2)
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scaled for landscape below As with the risk assessment sampling, the investigators took the most optimistic case and the most pessimistic case to bracket the uncertainty in the public health response. This approach provided an understanding of the upper and lower bounds of current, possible response capabilities, demonstrated which responses had the most impact, and the best possible reduction of risk with MCMs.
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Jacobson contended that the investigators' risk analysis has a fundamental flaw in that terrorists can choose the most optimistic setting for an attack, thus rendering the balance invalid. Casagrande explained that although terrorists would indeed like to have unlimited resources, in reality they do not have that choice.
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From page 53... ...
This information generates the exposure data for each of the different scenarios that are chosen for each of the different threats. From that point, modelers working in BARDA's A nalytical Decision Support area can assess the unmitigated to the mitigated benefit, forming the basis for the public health consequence assessments that are used for requirements setting -- which, although not directly related to the formulary study, is part of the overall process.
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