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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.

Cover of Medical Countermeasures Dispensing

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

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The Postal Model

The Cities Readiness Initiative (CRI) is a federally funded effort to help major U.S. cities and metropolitan areas respond effectively to large-scale bioterrorist events such as an anthrax attack (CDC, 2010a). Through the CRI program, state and large metropolitan public health departments develop plans to dispense antibiotics to the entire population of the metropolitan area within 48 hours. This is generally assumed to be the time window following an attack during which people must receive prophylactic antibiotics in order to prevent deadly inhalational anthrax. The CRI project began in 2004, and 72 cities and metropolitan areas are currently funded under the program, with at least one in each state.

The U.S. Postal Service (USPS) is working with select CRI cities to develop dispensing plans in which postal carriers who volunteer to participate in the program will deliver antibiotics to residences in certain zip codes. This model builds on the existing capability of the USPS to service every residential address in the country. 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 at points of dispensing (PODs) while they are being set up. The current intent of the model is not to replace the need for PODs. Ten million dollars were appropriated to HHS in the 2010 fiscal year to support the delivery of medical countermeasures; of this, up to 8 million dollars could be transferred to USPS. The funding was to remain available over a two-year period.

In 2006 and 2007, operational drills were conducted in Seattle, Philadelphia, and Boston. Results from these drills led to the development of a comprehensive pilot of this model in Minneapolis–St. Paul. Through extensive analysis, the Minnesota Department of Health discovered that they could not meet the 48-hour requirement by relying on more traditional mechanisms of medical countermeasures dispensing such as PODs that require the public to attend the POD to receive the countermeasure. Instead, their analysis showed that a push mechanism was required, that is, a process of actively pushing medication out to the population.

The development of the pilot program in Minneapolis–St. Paul involved collaboration among many stakeholders, including the state department of health, local public health, local and state law enforcement in Minnesota, the National Guard, HHS, the CDC, USPS, and the FDA. This section describes some of the challenges faced in developing the pilot, lessons learned, and solutions developed to address these challenges. It also highlights several areas for future work. First, however, the section briefly highlights recent developments related to the postal model.

Recent Developments

On December 30, 2009, President Obama signed an Executive Order concerning medical countermeasures following a biological attack (The White House, 2009). The order outlines what needs to be done to establish the federal government’s ability to provide medical countermeasures, in a timely fashion, after a biological attack such as anthrax. 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 necessary, local law enforcement personnel serving as security escorts with local federal law enforcement.

The expansion of the Postal Model for dispensing medical countermeasures has also been included in legislative proposals. In September 2009, Senator Joseph Lieberman introduced Senate bill 1649, the WMD Prevention and Preparedness Act of 2009, “a bill to prevent the proliferation of weapons of mass destruction, to prepare for attacks using weapons of mass destruction, and for other purposes.” If passed, it would direct the HHS Secretary to expand the Postal Model pilot program. This language also appeared in a House bill, H.R. 5057, The WMD Prevention and Preparedness Act of 2010. However, as of the writing of this report, neither of these legislative proposals had been taken up by the Senate or House, respectively, as a whole.

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. Paul area, there are 205,000 residences with an estimated 2.8 persons per home. That equals 575,000 persons who need to be covered within 20 zip codes. Within those zip codes, there are nine consolidated delivery units (also known as post offices or carrier annexes). The Minneapolis Postal Service determined that, by having each postal carrier who volunteers cover two normal postal routes, 179 volunteers can deliver medication to the entire 575,000 people within 8 to 9 hours. For security, one security officer would be assigned to each carrier, plus additional security for the consolidated delivery units that have been activated.

“The postal plan is not mandated for our employees; it is a volunteer program response to a wide-scale anthrax attack. From the start—from the very origin of this plan—it was recognized these had to be volunteers,” said Jude Plessas, manager of the CRI Postal Plan Program. The project currently has 385 qualified volunteers in Minneapolis–St. Paul—311 carriers and 74 from management. This is 80 percent more than what is needed in terms of carriers to cover the project area.

MedKits

To successfully complete a mission of this magnitude, volunteers themselves need to have rapid access to antimicrobials and personal protective equipment so they are protected as they deliver medication to the community. Families of the volunteers should have access to antimicrobials as well so that the volunteers would know that their families were protected. “They would not have to worry about seeing those family members into a POD or clinic and then get in to effect the mission,” Plessas said. In fact, the union leadership of the postal carriers and management at the USPS required, as a condition of participation in the program, that their members be provided with antibiotics in advance of an incident. “They felt they wouldn’t be able to respond minuteman-like if they didn’t have that stuff already in hand. The challenge then fell to the federal government to try and help in making that happen,” said Minson of HHS.

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. In this case, the kits contain doxycycline hyclate tablets. The kits are also known as Household Antibiotic Kits (HAKs). Qualified healthcare providers, under the auspices of the public health authorities, screened and cleared the postal carriers to receive the Med-Kits. Postal carriers who had a contraindication for doxycycline were not permitted to volunteer to participate in the postal program.

The use of MedKits has been controversial because of concerns regarding the ability of households to properly store and maintain the kits and to reserve them for emergency use, as well as safety concerns about the self-administration of prescription medications without medical supervision. A pilot study was conducted in St. Louis to evaluate the use of MedKits in households (CDC, 2007). They were provided to approximately 4,000 households. The study looked at the ability of households to maintain MedKits in the home as directed and reserve them for emergency use, and attitudes and perceptions regarding the MedKits. Participants included corporation employees, first responders, and clients and staff of a community health clinic. At the workshop, Laura Eiklenborg, formerly deputy director of emergency preparedness for the City of Minneapolis and now director of public-sector solutions at OptumHealth, pointed to this study as an example of what has worked in the pre-event placement of post-exposure prophylaxis. At the end of the study, 97 percent of participants were able to return their MedKits intact.

However, despite the promising results of the pilot study, others have noted that additional studies should be conducted to ensure safety and prevent misuse before the MedKit program is implemented on a wide scale (IOM, 2008). In particular, the pilot study was not able to test whether participants were able to accurately and safely prepare and use the medication by following the enclosed instructions during an actual emergency. Nor did the study test the effects of the conditions under which the MedKits were stored in participants’ households. At the workshop, Erin Mullen of PhRMA’s Rx Response noted that the bathroom medicine cabinet is one of the worst places to keep medications because it tends to be warm and humid.

Before MedKits could be provided to the postal carriers, however, the planners had to overcome a legal restriction. Specifically, given the materials and instructions in the volunteer kits, the FDA deemed the MedKit to constitute an off-label use, thus requiring an EUA. Following standard emergency protocol, the individual MedKits contain a 10-day regimen of doxycycline instead of the usual 60-day treatment regimen for anthrax exposure. The household kits included doxycycline and instructions for use to cover anyone in that household for 10 days—adults and children of all ages, including people with medical conditions, pregnant women; they even have preparation instructions for dysphagic adults. 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. This complicated the effort to obtain an EUA to cover the MedKits because an EUA can only be issued following the determination of a threat and declaration of an emergency, as discussed earlier. For all other EUAs that have been issued, the threat determination and declaration of an emergency were made after the emergency had been detected. In the case of the MedKits for the postal model, however, the Secretary of the Department of Homeland Security made the threat determination in advance of an actual event. He stated that there is a significant potential for a domestic emergency involving a heightened risk of attack with Bacillus anthracis (DHS, 2008). On the basis of this threat determination, the Secretary of HHS declared an emergency justifying an EUA for the MedKit. Based on the threat determination and the emergency declaration, the FDA was able to review the request and issue the EUA. Additional details, including the conditions of authorization, can be found in the letter of authorization (FDA, 2008).

Because the EUA is dependent on the emergency declaration, the EUA is valid until the emergency is declared over. The emergency declaration justifying the EUA was renewed in 2009, and continued to be effective as of the date of the workshop.

With the EUA in place, home MedKits were packaged and provisioned to the volunteers. Supplies for the delivery units were prepositioned and fit tests for N95 masks have been completed. In addition to the 10-day MedKits for placement in their households, Plessas said that individual-dose MedKits will be provided to the volunteers so they can be activated on the day of the emergency. These have also been called individual Household Antibiotic Kits (iHAKs). “Literally, if [the postal carriers] are there in the morning, or if they are coming off the street, we can send them back out,” Plessas said.

This EUA is the only EUA to have been issued before an actual event, and it was only the second EUA of any kind issued by the FDA. Therefore, those involved gained much experience and insight into the process. The lessons learned, as reported by the workshop participants, are detailed below.

Lessons Learned During the EUA Process

Negotiations and discussions about the EUA request were drawn out because, as Plessas explained, “The urgency of [an] attack already suffered didn’t exist.” Throughout the process, several issues came to light:

  1. 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. For example, the plan needed to address what happens if someone has the day off. Everything needs to be properly understood for the EUA to effectively and efficiently support the end-users in their mission. Plessas noted that direct dialog with the FDA might have helped smooth things along during the process.
  2. Forms: There was a huge disconnect between state and federal authorities about what basic forms, such as anthrax screening forms and patient information sheets, needed to look like. “Keep in mind that by this time in history, the states had spent at least 6 years developing their own screening form for things like anthrax; we already had those tools in place,” said Sell of the Minnesota Department of Health. “And then I was given a federal form that didn’t jibe with, for instance, our state epidemiologist, who has to sign off on these kinds of things.” Negotiating these types of differences was time consuming and difficult, especially because there was little clarity on what could be changed and what could not. The people who needed to be at the table discussing these issues weren’t present at the beginning, meaning that these issues had to be worked out late in the process.
  3. Roles and responsibilities: Roles and responsibilities need to be explicitly articulated in the EUA request, or amendments may be necessary after the EUA is released, Plessas said. This occurred with the postal EUA. After the EUA was released in October 2008, amendments were made that went into effect in February 2009. Two additional minor changes were being pursued as of the date of the workshop.
  4. Communication: Specific to the postal EUA, an HHS press release went out to the general public about the program before the volunteers had received the final word from postal management. This resulted in some internal consternation. The take-home lesson is that internal partners and stakeholders should be kept up to date before anything is released to the public.
  5. Medication expiration dates and annual renewal requirements: As currently stated in the EUA, MedKits have an annual expiration date, with an annual renewal process in place. Eiklenborg noted that it requires significant effort from both USPS and public health authorities to manage the logistics related to the expiration of drugs, redispensing medications, and rescreening volunteers.

Security and Workforce Protection

The Postal Model relies heavily on law enforcement to protect the USPS workers and the stockpile. The postal carriers who volunteer need to feel safe to complete their mission, and the delivery units (post offices and delivery annexes) need to be secure areas for the medications to be processed for delivery.

In developing the pilot, the Minneapolis Department of Health determined what was needed to complete the plan, and then presented the findings and the mission to the local and state law enforcement agencies in the area to seek their collaboration. They began by determining what the law enforcement requirements would be for the postal model, compared with what would be needed to provide security for a plan that was based solely on PODs. It became clear quickly that, while the demand on local law enforcement in the first 12–24 hours of the postal model is slightly higher, demand remained much more intensive with the PODs, requiring multiple shifts over multiple days. “It became readily apparent to the law enforcement partners that the postal model actually provides the best opportunity for the optimization of law enforcement use in getting meds into people’s mouths,” Plessas said. Nevertheless, the law enforcement requirement—one law enforcement officer to accompany each postal carrier—continues to be considered one of the more challenging aspects of the postal model.

Despite these concerns, by taking advantage of existing memorandums of understanding among the Minneapolis Police Department, the St. Paul Police Department, and the Minnesota State Patrol, there are now commitments well in excess of what is actually needed to execute the postal model as it currently stands.

It is important to note that the postal EUA is specific to postal employees, so it does not cover the law enforcement partners. Therefore, these partners are not able to have MedKits pre-positioned in their homes. 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. He mentioned an example of a hospital emergency department being overrun in Memphis when 2009 H1N1 vaccine was first available. “Security is definitely still an issue and [it] needs to be resolved and talked about a lot more,” he said.

Areas for Future Work

Workshop participants discussed areas for future work arising from the issues seen in the Minneapolis–St. Paul pilot of the Postal Model for dispensing medical countermeasures. The key areas were an EUA to cover first responders, as well as issues surrounding expiration dates and which medications are included in the model.

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. Several workshop participants noted that these law enforcement officers would have the same safety concerns for themselves and their families as the postal carriers who have been provided with MedKits. Providing MedKits only to the postal carrier could raise questions of equity. Furthermore, because the model calls for each postal carrier to be accompanied by a law enforcement officer, these first responders must be available to begin the dispensing route as quickly as possible. However, there are a number of challenges associated with developing such as EUA, including lack of familiarity with EUAs and the complexity of the first-responder community.

Tim Conley, director of preparedness and planning for the Village of Western Springs Department of Fire/EMS Services and Emergency Management in Illinois noted that most first responders have never heard of EUAs. “In general there is a huge lack of understanding and training in the first responder community when it comes to public health. They do not know what they are facing,” he said. “We would run into a fire, point, go. They will go. They will chase the bad guys down the street, getting shot at. They will run at them, they will go. [But] they do not understand a biological event.”

The second, more difficult challenge is that the first responder community has a very complex structure that varies across jurisdictions. Even within one metropolitan area, there are multiple law enforcement agencies operating. By contrast, the USPS is one federal entity—a postal carrier in one city has the same paycheck, reporting structure, mandate, job responsibilities, and even uniform as a postal carrier in another city. In fact, the postal model and its associated EUA are not specific to Minneapolis–St. 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.

As Minson explained, “EUA requires [that] you have some element of medical direction, an accountable measure, a reporting structure and ultimately the ability to recoup the kits if the EUA comes to determine this. When you start to talk about the very complex interplay with emergency service districts and EMS and fire departments and shared personnel . . . it begins to look like you really want to get . . . not so much an EUA, but an approved kit if that is where you are going to go.”

Although EUAs are extremely helpful, Plessas said, “EUA is not the desired end-state. It exists to bridge to some kind of FDA-endorsed Med-Kit. At some point we need them move out what’s an emergency use—recognize that this threat continues to exist and move toward being able to have a MedKit available.” He suggested that a future MedKit could go beyond just treating for anthrax, perhaps expanding to include materials that could be deployed for multiple threats.

Mullen of PhRMA and Rothholz of the American Pharmacists Association also noted that restricting MedKits to first responders (as well as postal carriers) may raise issues of equity. They noted that many other people may be considered “essential personnel” and provide critical services during an emergency. Rothholz noted that if pharmacists are not available to handle their regular patient needs, then the healthcare system may become overloaded. Mullen said many companies had told her that all of their personnel are essential to their operations, and they were not willing to categorize their employees in this way. When asked whether she advocated that everyone receive a MedKit, Mullen replied that it should at least be considered.

Expiration and Annual Renewal Process

Workshop participants discussed various issues surrounding drug expiration and the annual renewal process, in order to avoid having to collect MedKits annually from each household and reissue new ones. Suggestions ranged from stocking medications with longer expiration dates to including more shelf-life potency testing and data collection in the drug development process. 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.

Choice of Medication

Workshop participants brought up the fact that the Postal EUA only covers the placement of doxycycline, while Ciprofloxacin is also indicated in the clinical guidelines for the prophylaxis and treatment of inhalational anthrax. The SNS and local caches include both drugs. Eiklenborg noted, “First responders and mission-critical personnel outside of the postal workers will actually have access to either indicated antibiotic, Cipro or doxy.” She noted that while 98 percent of the population is indicated for doxycycline, “The discrepancy between the available types of antibiotics for postal really is inconsistent and it is confusing.”

Workshop participants noted that, during the anthrax attacks in 2001, people in certain areas were given doxycycline, and people in other areas were given Ciprofloxacin. Even though both are indicated for the treatment of anthrax, Ciprofloxacin costs more than doxycycline, and was therefore perceived as better. Regarding the postal model, there has been no pushback on the use of the cheaper doxycycline because the postal workers are volunteers who were told at the onset that doxycycline would be used, and to qualify for the program, they could not be contra-indicated for doxycycline.

Copyright © 2010, National Academy of Sciences.
Bookshelf ID: NBK53124
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