Medical Countermeasures Dispensing Emergency Use Authorization and the Postal Model: Workshop Summary (2010) / Chapter Skim
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Workshop Summary
Workshop Summary
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, when a public health emergency occurs, the best 1 The workshop series was organized by an independent planning committee whose role was limited to the identification of topics and speakers. This workshop summary was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshops.
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Forum on Medical and Public Health Preparedness for Catastrophic Events convened a meeting to discuss recent progress made in the nation's ability to rapidly and effectively deploy medical countermeasures in response to public health threats, along with remaining challenges and vulnerabilities, and strategies to address these challenges in future work. About the Preparedness Forum The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events was established to foster dialogue among a broad range of stakeholders -- practitioners, policy makers, community members, academics, and others -- and provide ongoing opportunities to confront issues of mutual interest and concern.
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. At the workshop, participants discussed lessons learned and opportunities for enhancing future medical countermeasures dispensing efforts based on their experiences during the response to 2009 H1N1.
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Since the workshop, President Barack Obama has issued an Executive Order that, among other provisions, orders the federal government to pursue a national U.S. Postal Service medical countermeasures dispensing model to respond to a large-scale biological attack (The White House, 2009)
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Any opinions, conclusions, or recommendations discussed in this workshop summary are solely those of the individual participants and should not be construed as reflecting consensus or endorsement by the workshop, the Forum on Medical and Public Health Preparedness for Catastrophic Events, or The National Academies. BOX 1 Glossary of Key Terms Cities Readiness Initiative (CRI)
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These include the Cities Readiness Initiative (CRI) , Project BioShield, the Public Readiness and Emergency Preparedness Act (PREP Act)
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Following that, it highlights two innovative public–private partnerships that were formed during the response: the Commercial Supply Chain Dashboard and the unprecedented level of involvement of pharmacies and pharmacists in countermeasures dispensing. Finally, the section mentions remaining issues to be addressed in order to enhance public–private partnerships, and outlines efforts recently made to provide liability protection for those involved in medical countermeasures dispensing.
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For example, in the case of an anthrax release, the time for response is extremely short, but the affected geographic area may be more restricted than other threats. In response to these particular challenges, the CRI and the Postal Model, discussed in detail later in this summary, focus on dispensing antibiotics to the entire population of the nation's largest cities and metropolitan statistical areas within 48 hours, using mechanisms such as PODs and delivery by postal carriers.
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This subsection outlines the time line and logistical considerations of the SNS's response to 2009 H1N1, describes the development of a new public–private partnership designed to improve situational awareness of the commercial supply chain in order to enhance decision making and streamline information sharing, and highlights some areas that participants identified for additional work to enhance future responses. Time Line and Logistics In early spring, the CDC confirmed two cases of H1N1 in humans in California, the same virus determined to be circulating in Mexico (Box 2)
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Fall Timeline • August 25, 2009: Commercial Supply Chain Dashboard initial meeting with commercial partners. • October 1, 2009: Deployment of 300,000 Tamiflu oral suspension regimens.
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In October and November, an additional 540,000 Tamiflu oral suspension regimens were deployed from the SNS as public health officials geared up for the reappearance of 2009 H1N1 during the traditional flu season. In addition, 59.5 million N95 respirators -- personal protective equipment that protects against the transmission of virus -- were distributed to state and local health departments.
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The dashboard also represented an important step toward coordinated communications among stakeholders, and real-time situational awareness to help federal agencies and state public health departments make decisions. Several participants noted that bringing this kind of public–private partnership to other areas of public health preparedness and response could significantly enhance future efforts.
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," he said. It is not only federal officials that benefit from situational awareness about the private-sector supply chain; this is also critical information for state and local public health authorities' planning and response efforts.
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Jack Herrmann, senior advisor for public health preparedness at the National Association of County and City Health Officials (NACCHO) , noted that this is a shortcoming that "is on our list of things to improve." Finally, some participants noted problems with communication from DSNS to state public health authorities about the timing and content of upcoming shipments.
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. Challenges Facing Public Health Departments State and local public health agencies are where medical countermeasures dispensing is implemented.
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As mentioned above, this made it more difficult for state public health officials to develop effective response plans. Implementation Challenges in the 2009 H1N1 Vaccination Program Although the CDC and other federal entities provided guidance during the response to 2009 H1N1, state and local public health departments were responsible for developing plans to administer the vaccine.
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3 In many cases this caused logistical problems, such as forcing public health departments to cancel previously advertised plans for mass vaccinations because vaccine was unavailable. These issues were discussed in much greater depth in the Preparedness Forum's regional workshop series examining the 2009 H1N1 vaccination campaign.
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They see it as an opportunity to challenge their systems and identify where those gaps are." Public–Private Partnerships Public–private partnerships are a critical component to successful medical countermeasures distribution and dispensing, according to many workshop participants. As Blumenstock said, "It is a requirement to really create a hybrid environment of both public and private assets, because certainly governmental entities can't do it alone, recognizing the amount of material, the time limits, and the challenges of distribution and administration." The Commercial Supply Chain Dashboard, discussed earlier, is a good example of how public and private entities can work together to tackle critical issues in dispensing medical countermeasures, such as im
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Payment Who pays for medical countermeasures dispensing? The government provides the product, but providers, such as pharmacists, are responsible for compounding the medication.
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Although guidelines are given from the national level, each state and local public health department may have the flexibility to decide the best way to serve its population. This means the private sector can be faced with a broad range of plans, which can be inconsistent and difficult to administer.
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Liability Protection and the PREP Act Various legal provisions have been implemented to provide protection from liability and to support healthcare providers, other workers, and private-sector entities' involvement in public health responses. Brooke Courtney from the Center for Biosecurity of UPMC noted: "It has been well established that during public health emergencies, the legal landscape can dramatically [change]
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. Issuing a PREP Act Declaration A PREP Act declaration is distinct from an HHS declaration of a public health emergency and requires no additional emergency declarations.
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Covered persons may include • United States; • Manufacturers and distributors of countermeasures; • Program planners (e.g., those involved with planning and admin istering programs for countermeasures distribution) ; • Qualified persons (e.g., licensed health professionals)
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They suggested that some people may not understand the extent of the protections provided by the PREP Act, and therefore may be more hesitant to become involved in dispensing medical countermeasures. Workshop participants also discussed a question that many said could benefit from further consideration and perhaps further action to address the situation: What is the legal situation for multiple pieces of the same equipment used in a single hospital during a disaster response, when some of those pieces of equipment came from the SNS and other pieces were already owned by the private hospital?
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However, ventilators owned by private hospitals might not be covered under the PREP Act, unless the local public health authority states that everyone needs a ventilator. Workshop participants said this situation could cause a great deal of confusion and would require additional documentation and detailed tracking of equipment provenance, which would likely not be feasible in an emergency situation.
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The Role of EUA Within the FDA's Mission EUAs are issued by the FDA and, therefore, reflect the FDA's mission to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation. The FDA is responsible for the following areas related to counterterrorism and emerging threats: • Facilitating the development and availability of medical coun termeasures; • Protecting the safety and security of regulated medical products; • Enhancing emergency preparedness and response capabilities;
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The emergency can be a military, domestic, or public health emergency that affects, or has a significant potential to affect, national security. Agents involved include chemical, biological, radiological, or nuclear agents.
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Pre-EUA Although the law does not allow the FDA to preauthorize an EUA before the determination and declaration of an emergency, the process can begin before the actual emergency occurs. Specifically, a request can be submitted to the FDA regarding situations that may happen, such as potential anthrax attacks or smallpox outbreaks.
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EUAs may waive a number of regulatory requirements to allow unapproved products or approved products to be used in unapproved situations as emergency medical countermeasures. Typically, for instance, when an unapproved product is used in a clinical setting, it requires either informed consent or review and approval by an institutional review board.
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This is where roles are clarified, and specific conditions are laid out for different parties, such as public health authorities, manufacturers, healthcare facilities and providers, and others who dispense or distribute the products. Examples of what can be addressed within the conditions of authorization include the following: • Specific information for healthcare practitioners and authorized dispensers; • Specific information for recipients; • Adverse event reporting and monitoring; • Recordkeeping/access; • Restrictions on distributing and administration; • Restrictions on advertising; • Data collection and analysis; and • Compliance with good manufacturing practice.
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"If we can't be sure that the product is covered by one of those FDA mechanisms, we can't necessarily guarantee that the PREP Act for liability coverage would remain in place." Successes in the Response to 2009 H1N1 The response to H1N1 was made possible largely because of the use of multiple EUAs, which allowed use of a yet-unapproved antiviral medication, deemed to be critical in caring for severely ill patients, and extended the use of other antiviral medications and countermeasures to larger populations than would otherwise be allowed. EUAs also assisted public health authorities with addressing challenges such as labeling restrictions and changes in the information provided to recipients of the countermeasures.
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• Permits distribution or dispensing without complying with certain prescription label requirements • Allows for use in patients who are symptomatic for >2 days or sick enough to be hospitalized • Authorizes distribution of SNS SLEP Tamiflu • Notes that persons may distribute to recipients in accordance with applicable state and local law and/or in accordance with the pub lic health and medical emergency response of the authority having jurisdiction Relenza® (zanamivir) • Permits distribution or dispensing April 27, 2009 without complying with certain (amended April 27, prescription label requirements 2009)
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The first part of this document described several aspects of medical countermeasures dispensing in response to the 2009 H1N1 pandemic, including distribution from the SNS, challenges faced by public health departments, public–private partnerships, and liability protection. This second look at the response to the 2009 H1N1 influenza pandemic focuses on the use of EUA during the response, improvements to the EUA process based on this experience, and areas that should be addressed when moving forward.
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The lots would have needed to be sent to a relabeler, then back to the SNS for redistribution to the states. "If the public health authority wanted to [relabel]
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While by no means a comprehensive review, some of the more pressing concerns and needs are described below. Communication About EUAs Workshop participants noted that despite efforts by the FDA and the CDC to post EUAs and associated information on their websites, many providers, public health officials, their legal counsels, and members of the public continued to have questions about EUAs in general, and about the specific EUAs issued in response to 2009 H1N1.
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Gloria Addo-Ayensu, health director of the Fairfax County Health Department in Virginia, suggested that information given to providers be put into simple bullet points, so that when patients ask about the risk associated with the medication that is being prescribed, the physician has a quick and easy reference. She noted, "Patients often ask their providers what the risk of using the drugs are and so on, and many practitioners don't have any idea, which in itself is a liability issue." Fact Sheets and Documentation The need to create millions of fact sheets that explain to patients what medication they are taking, how to take it, and what side effects may occur, along with documentation tracking medical countermeasures dispensing, is a major challenge for emergency planners and responders.
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I can't magically generate 5 million forms for a small state." Many states have already spent significant time, money, and staff resources working on documentation such as screening forms for their emergency preparedness and response plans. But those forms may not be exactly what are required under an EUA.
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That is something that we are working to address." Labeling According to Gorman, current legal interpretation of the PREP Act coverage requires EUAs for reasons that have nothing to do with whether a drug is FDA approved for the emergency at hand, but often for simple labeling issues. For example, many medications stored in the SNS have "for SNS use only" on the label.
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" Streamlining and Standardizing the EUA Process Workshop participants acknowledged that, as people have gained more experience with EUAs, the process has become smoother. It is known now what information needs to be provided to the FDA, and the lines of communication are more open.
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more uniformity with respect to it." Beyond EUAs Several workshop participants emphasized that although EUAs facilitate getting appropriate materials where they are needed in a timely fashion, they are not the ideal end solution. As Minson said, "The idea here is not to have an interminable number of EUAs that are being kicked out, but ultimately to say at some point that this is a ‘patch.' This gets us to where we might want to be on a permanent footing." Many workshop participants questioned whether EUAs are currently required for too wide a range of medical countermeasures dispensing situations.
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The postal model is intended to increase the speed of medical countermeasures dispensing, and to supplement local capacity and as well as reduce the population surge
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To do this, it mandates the establishment of a national USPS medical countermeasures dispensing model within 180 days of the date of the Executive Order. Also included are the directives to establish what needs to be done for a federal rapid response and a corresponding concept of operations, with the development of an accompanying plan to supplement, as neces
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These efforts to expand the postal pilot to a national scale make the logistical plans, lessons learned, and areas for future work identified by workshop participants even more important and relevant to national medical countermeasures dispensing efforts. Logistics In the Minneapolis–St.
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In response to this concern, postal carriers who volunteer have received MedKits to keep in their homes. MedKits are medical kits containing supplies of needed prescription pharmaceuticals for use by members of the household only as directed during a declared public health emergency.
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Because of both the 10-day regimen and the written information that would accompany the medication, the kits were identified as involving the unapproved use of an approved product, thus requiring an EUA. Postal Model EUA As noted above, a key feature of the postal model is that the postal carriers who volunteer are provided with MedKits to keep in their homes before an emergency occurs.
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End-user needs: Targeted end-users should brief the FDA directly on issues such as operational response requirements, Plessas said. In the case of the postal model, many operational considerations needed to be addressed because volunteers were going to act as medical countermeasures responders.
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5. Medication expiration dates and annual renewal requirements: As currently stated in the EUA, MedKits have an annual expira tion date, with an annual renewal process in place.
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Instead, Plessas explained, "They have a cache program for prophylaxis whereby there is a cache dedicated for emergency responders within the Twin City areas." Programs to supply emergency responders with protective equipment such as N95 respirators are also in place within the different departments. Although much of the workshop discussion focused on the security requirements of the postal model, FedEx's Mugno also emphasized that security is a concern throughout the countermeasures dispensing system.
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EUA for First Responders Workshop participants discussed the idea of creating an EUA for first responders that would be similar to the one for the USPS postal carriers who volunteered to participate in the countermeasures delivery plan. This would enable the law enforcement officers who accompany the postal carriers on their routes to also have MedKits in their homes.
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Paul, but can be applied to any CRI location where the participating public health authority is willing to take on the roles and responsibilities spelled out in the postal model and the EUA. In order to have an EUA for first responders, there would need to be some type of umbrella structure that can create the ability for the fragmented community of first responders to act together.
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In fact, Gorman stated that stability and potency testing for a 10-year period has already been added to some of the new contracts for products that are not yet FDA approved, in order to avoid going through the Shelf-Life Extension Program. Mullen reminded participants that regardless of the conditions of the EUA, many state dispensing laws are stricter than federal laws, and most limit prescriptions to one year, thus necessitating annual renewal.
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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.
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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.
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