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Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events. Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model, Workshop Summary. Washington (DC): National Academies Press (US); 2010.

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Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model, Workshop Summary.

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Conclusion

Since the anthrax attack in 2001, many new plans, programs, and tools have been developed to enable rapid and effective medical countermeasures dispensing, including EUA, the PREP Act, Project BioShield, the Cities Readiness Initiative, and a pilot of the Postal Model. These activities have been directed toward countermeasures distribution and dispensing for public health emergencies such as a rapidly emerging anthrax attack or widespread influenza pandemic.

The response to 2009 H1N1 provided many workshop participants and their respective organizations with extensive practical experience; insight into how tools, legislation, and plans function during an actual response; and the opportunity to refine procedures and develop stronger partnerships among stakeholders. In particular, participants described two public–private partnerships that significantly enhanced the effectiveness and efficiency of the countermeasures dispensing system: one project improved situational awareness of the supply chain and the other enabled pharmacies and pharmacists to administer 2009 H1N1 vaccine. At the same time, participants noted several areas where additional discussions and work could further enhance these partnerships, including issues related to payment, communication, documentation and data collection, working with multiple jurisdictions, and liability.

Among the developments that occurred during the 2009 H1N1 response was the issuance of an unprecedented number of EUAs that allowed the use of approved countermeasures for unapproved uses, and in one case, the use of a medication that has not yet been approved by the FDA for any use. Workshop participants discussed how this provided stakeholders with much greater experience and understanding of the process involved in issuing EUAs, and also resulted in improvements to these processes. Nevertheless, participants identified a number of areas in which further work would be beneficial, including education and communication about EUAs, fact sheets and documentation, SLEP, labeling, EUAs and state dispensing laws, data collection, and streamlining and standardizing the EUA process. Several participants emphasized that although EUA is an important tool for disaster response, it is not always the ideal end solution, particularly for high-risk scenarios in which countermeasures already exist and the response needs can be anticipated. They said that the end goal for these kinds of countermeasures should be an approved product. Over the course of the workshop, participants also discussed other potential solutions that could help move beyond reliance on large numbers of EUAs during disaster responses.

Despite the progress made during the 2009 H1N1 response, many workshop participants noted that the next public health threat may be even more challenging. The next threat could be more lethal and fast moving; there may not be any approved medications to treat or contain the problem; legal concerns could prevent healthcare provider and private-sector organizations from fully supporting response efforts; and communication gaps could lead to public confusion and suppress acceptance of the medical countermeasure.

The Cities Readiness Initiative, including the recent pilot of the Postal Model, is designed to specifically address a fast-moving threat that requires countermeasures dispensing within a short period of time. Workshop participants involved in the pilot in Minneapolis–St. Paul described the features of this program, outlined the challenges they had faced in developing and implementing it, and shared the solutions they had found to address these challenges. These insights should be particularly useful as the pilot is extended into a national model, as required by President Obama’s Executive Order. Participants also mentioned several areas for future work, including an EUA to allow first responders to have MedKits in their homes and issues about expiration and the annual renewal process.

Overall, a recurring theme of the workshop was that much progress has been made in the area of medical countermeasures dispensing, but much work remains to protect the health of the public in the face of biological, chemical, radiological, and nuclear threats.

Copyright © 2010, National Academy of Sciences.
Bookshelf ID: NBK53128

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