Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise (2021) / Chapter Skim
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3 Ensuring That PHEMCE Decisions and Recommendations Are Defensible
3 Ensuring That PHEMCE Decisions and Recommendations Are Defensible
Pages 41-50
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From page 41... ...
were described as not fully scientific, justifiable, transparent, adaptive, or accountable. Political transitions were described as limiting PHEMCE's effectiveness, with changes in the presidency leading to inappropriate neglect of estab lished practices and mandates, often without repercussions.1 SOUND BUSINESS PRACTICES Formal and Informal Processes Organizations depend on both formal and informal management processes for their success.
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-- a recommendation that could be readily operationalized within a mission-appropriate QMS. A QMS creates stable and predictable business practices, structures change control and documentation practices, and supports a culture of continuous learning.
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published the Q10 Pharmaceutical Quality System,4 which is considered guidance in the United States but a rule elsewhere. The International Society for Pharmaceutical Engineering published its Baseline Guide 55 on Commissioning and Qualification of pharmaceutical manufacturing facilities and Good Automation Manufacturing Practices6 for ensuring quality management in manufacturing facilities.
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Faced with a related priority-setting dilemma, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus adopted a process that might guide PHEMCE priority setting (NASEM, 2020) : • adopting widely acceptable ethical principles (maximize benefits, equal regard, mitigate health inequities, fairness, evidence based, transparent)
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. When applied comprehensively, it considers the entire MCM life cycle, including threats to supply chains, storage and maintenance, deployment, and usability, given recipients' training, legal constraints, and competing duties.
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KPIs should provide the information needed by external stakeholders (e.g., companies stockpiling product, entities administering it) ; address the whole of PHEMCE and the life cycle of its MCM, reflect its overall goals, and inform its budgetary process; and be as stable as possible, to allow comparisons across time, while being flexible enough to reflect changes in PHEMCE and the world, and both backward looking (asking
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Another form of joint evaluations that could address PHEMCE operational assumptions is preparedness "sprints"9: rapid simulation exercises, involving the people and organizations that will use MCM systems, in realistic scenarios, at appropriate scales. They are designed to test processes and systems for specific scenarios, to reveal gaps and challenges, and should simulate both likely and emerging threat scenarios, which range in size but should also dovetail with real-life need and deliver a public good, including progress toward an MCM for public health.
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While classification concerns pose challenges for cross-agency data systems, too much classification limits sharing of and access to information that encourages innovation and participation. CONCLUDING REMARKS The committee heard many reports of failures in PHEMCE's operations.
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2019. Disruption risk mitigation in supply chains: The risk exposure index revisited.
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2017a. Building communication capacity to counter infectious disease threats: Pro ceedings of a workshop.
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