Addressing the Smallpox Threat

Transcript of Web-assisted Audioconference

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This Web-Assisted Audioconference, broadcast on March 3, 2003, was the first in a series on bioterrorism conducted throughout 2003 via the World Wide Web and telephone. This Web conference was designed to address the issues and activities related to preparing our Nation to respond to the potential threat of a smallpox outbreak. The User Liaison Program (ULP) of the Agency for Healthcare Research and Quality (AHRQ) developed and sponsored the program.

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Jeffrey Levine: Welcome to Addressing the Smallpox Threat: Issues, Strategies and Tools. This is the first event in a series of Web-Assisted Audioconferences on bioterrorism and health systems preparedness designed for State and local health policymakers and health systems decision-makers. This series is sponsored by the U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, often referred to by the acronym AHRQ.

My name is Jeffrey Levine and I will be your moderator for today's session. The context for these calls is clear and compelling. Bioterrorism represents a significant public health threat to the United States. Addressing this threat requires the rapid development of Federal, State and local capacity to respond to potential bioterrorism events. To be as effective as possible, these efforts must be directed toward improving the abilities of both our public health system and our health care delivery system, including the individual systems of care, facilities and clinicians that comprise the latter to detect and respond to such threats.

In addition, these efforts must ensure that all of these components communicate and coordinate effectively with one another and with other related systems such as emergency preparedness and law enforcement. The State and local health policymakers, program administrators and health system decision-makers, the intended audiences for these calls, all play an essential role in these efforts. Within their own jurisdictions, regions or delivery systems they must develop capacity and coordinate efforts across public health, health care, law enforcement and related systems. It is therefore extremely important that they have information about emerging health services research, promising approaches and available tools that assist in the development of readiness plans.

In addition to today's event, four other calls will be conducted as part of this series. The next call, scheduled for April 15, will examine issues, experiences and tools related to disaster planning drills and readiness assessment. The third call on June 17 will focus on surge capacity assessments and regionalization issues. The topics for the fourth and fifth calls will be selected at a later date. I will tell you more about these calls later in the broadcast, but right now let's turn to today's discussion of important activities, health services research and newly-developed tools that can help our health care system be prepared to address the threat of a bioterrorist-caused outbreak of smallpox.

Let me begin by introducing today's panelists. In the studio with me I have William Raub, Deputy Assistant Secretary in the Office of Public Health Emergency Preparedness at the Department of Health and Human Services; Nancy Ridley, Assistant Commissioner of the Massachusetts Department of Public Health; Eddie Gabriel, Deputy Commissioner for Preparedness in the New York City Office of Emergency Management; Nathaniel Hupert, Assistant Professor of Public Health and Medicine at the Weill Medical College of Cornell University; and Thomas Terndrup, Director of the Center for Disaster Preparedness and Professor and Chair of the Department of Emergency Medicine at the University of Alabama at Birmingham.

Welcome everyone and thank you for joining us. Before we begin our discussion I would like to tell you a bit about the format of this audio conference. Discussions with our five panelists will be followed by a question and answer session in which we will open the lines to take your questions. We will provide you with instructions on how to send us your questions later on in the program. In the meantime, if you experience any Web-related technical difficulties at any time during this event, please click on the "Help" button in your window to troubleshoot your Web connection. If it appears that the slides are not advancing, you may need to restart your browser and log on again. If you are on the phone, dial "*0" to be connected to technical assistance. Also, if you have any difficulty with the audio stream or if there is an uncomfortable lag time between the streamed audio and slide presentation, we encourage you to access the audio via your phone. The number is 1-888-496-6261 and give the password "bioterrorism" to be connected to the call.

Now I think we are ready to be ready to discuss today's topic, Improving Health Systems Preparedness to Address the Potential Threat of Smallpox Outbreak. Let me begin with Bill Raub, Deputy Assistant Secretary in the Department of Health and Human Services' Office of Public Health and Emergency Preparedness. Bill, why is smallpox the number one bio-threat agent?

Dr. William Raub: Several considerations come together to put smallpox right at the top of the list in terms of threat agents. First off, it is highly lethal. Thirty percent of people exposed can expect to die and of those who survive there can be lifelong serious morbidities of various types.

Second, the disease is readily communicable from person to person. Respiratory droplets are sufficient to carry the virus and therefore ordinary day-to-day contact can be a sufficient exposure to move along the disease.

Third, few people have effective immunity. One of the great triumphs in the history of public health was the eradication of smallpox from the world, so declared in 1980 by the World Health Organization. The United States stopped vaccinating in the 70's and individuals born since that time have no immunity and those of us who were vaccinated earlier have little or none, depending on the length of time involved.

Fourth, we have no established treatment. The vaccine itself is protective within a few days of exposure but once the symptoms present, we have no drugs or other means to treat much less to cure this disease.

Last but not least, enemies of the United States are going to have the variola virus, the virus that causes smallpox. We know that the former Soviet Union produced huge quantities of the virus for its biological weapons program. With the break up of the former Soviet Union, as scientists and engineers left that country, we fear that they left with more than their know-how. They may indeed have left with samples of the virus involved.

Jeffrey Levine: What is the scope, Dr. Raub, of the current smallpox vaccination campaign?

Dr. Raub: First I would stress that the program is entirely voluntary. Smallpox does not exist in the world right now; therefore we believe it would be inappropriate to have any mandatory vaccination campaign for a disease that does not exist. But because of the bioterrorist threats some preparation seems important. So we have identified three stages. The first stage is a focus on epidemiological response teams, that is, the individuals who would be called upon to investigate the first suspected or actual cases of smallpox and therefore would likely be the first individuals exposed.

Second would be other health care workers. Public safety personnel, others who once there were an outbreak of smallpox would be among the very first to be exposed to cases and who would want to be protected to be able to carry out their basic responsibilities.

Stage three, as declared by the President, would open this eventually to private citizens, as he put it, "those who insist upon being vaccinated."

Jeffrey Levine: Why is the program limited in this way?

Dr. Raub: We placed the limits as a trade-off between the fact of the absence of smallpox at the moment and the fact that the vaccine, while highly effective, can nevertheless provoke serious adverse effects. The approach therefore is to offer the opportunity for vaccination to those at the highest occupational risk but not to require it, to leave it to the best judgment of those individuals and their employers as to whether they should be vaccinated now.

The United States is prepared, thanks to extensive planning by each of our States, to do large-scale vaccinations should there be an actual outbreak, but we are recommending that those in the first line of exposure, the epidemiological response team and other health care workers and traditional first responders in fire and public safety personnel, seriously consider being vaccinated now.

Jeffrey Levine: Now, what are the current major issues associated with the vaccination program? Of course, there are several.

Dr. Raub: The States and the Department of Health and Human Services have encountered two major issues. First off, the logistics and cost of stage two. Most of the States seem comfortable with the numbers and the logistics associated with the first stage and are finding the funds to do that. But as they look ahead to the second stage with potentially up to ten million people involved, working out the type of distribution system, the types of clinics or other arrangements, access that would be required plus the costs of that are not trivial. So a number of the States are struggling with that right now.

Also many people have expressed concern about the absence of guaranteed compensation for vaccine-related injuries. That is in many States, workman's compensation is covering the compensation needed for vaccine injuries but not in all States. Many health insurance programs provide coverage for the health care costs associated with adverse events, but not all of it. In any case, none of them covered the costs associated with lost work. So a number of our State officials and hospitals and others are moving very cautiously with the view of hoping there will be a solution to the compensation problem.

Jeffrey Levine: Thank you very much, Bill. I would like to turn now to Nancy Ridley, Assistant Commissioner of the Massachusetts Department of Public Health and take a look at her State's efforts to address smallpox-related issues in the context of its overall bioterrorism preparedness plan. Nancy, we know that all State plans are not the same. However, it would be helpful to look at your State as an example. Can you describe for us some of the core elements of the Massachusetts plan?

Nancy Ridley: Certainly. Massachusetts is a fairly small State, small in geography but very high density. We have about 6.5 million residents in the Commonwealth. One thing that differs from many other States is that we don't operate on a county health system. We have 351 cities and towns. Our 76 acute care hospitals with emergency rooms make up the core of our acute care system. We have divided the State recently into seven emergency response-planning regions. The map shows the seven emergency response planning areas. What we have done is to base this on our emergency medical services (EMS) system break out of the State with some further breakout in the eastern part of the State so that we have an equal number of hospitals and population in each of the sections.

Jeffrey Levine: Did you want to go through some of the details now?

Ms. Ridley: Yeah. The details of the plan itself, we had a statewide smallpox workgroup as I think every State has had, that included about 40 or 50 very active constituents, representatives of many, many different segments.

The pre-event plan itself is based on Phase 1, what we call Phase 1, which is the first phase that Bill was referring to. We have two components to it. The first is the hospitals. We are going to be vaccinating about 7,600 hospital staff, averaging about 100 per hospital. In the second part of Phase 1, we are going to be doing 2,400 community response team personnel. In each of those 7 regions we are going to have 16-member response teams that are capable going out. In order to be able to ensure that we have 16-member response teams we are going to have to do probably about 150 individuals per region. From there we have set some very basic criteria for those 10,000 individuals that will make up either the hospital or the community response team.

The basic criteria for getting a vaccination, number one you must have been previously vaccinated. Second of all, there will be very careful screening of the individuals as well as household contact for contraindications. Third, there will be extensive follow-up required for adverse reactions. The fourth component, this is very, very critical, is that we are not advocating or recommending or proposing to do furloughs.

In terms of what process we are going to use for an orderly progression, first we start and we did start with our own State health department professionals. The second phase of this will be to proceed to vaccinating multidisciplinary teams at the 76 hospitals. Third, once we have completed the hospital teams, we will be proceeding to doing the seven regional response teams. We are trying to build capacity in particular to include public health nurses, school nurses and visiting nurse associations in this process.

From a timeline perspective, we began our process in Massachusetts on February 12 with our initial vaccinations. This again was with the first 15 of the State's health department personnel. We then will be carrying out Phase 1A, which is the hospitals, for approximately the next three months. Then we will be proceeding after the hospitals are completed to vaccinating the community-based response teams. All in all, this is probably going to take up to six months to get through both the first and second parts of what we call Phase 1.

The vaccination process itself for hospital response teams, as I said the DPH did start the process on February 12 and we did vaccinate the first actually 15 public health employees about two and a half weeks ago. I am happy to report we have had no adverse effects. No lost time at all from any of our vaccinees. The only slight reactions we have had were some tape hypersensitivity reactions to the bandage and we found if you leave the bandage on for 3-5 days as opposed to changing it daily that even that slight reaction is one that we no longer have.

So basically what we have done is we have started with our State public health employees. We have actually also as of last week we added Cambridge Health Department and Boston Health Department employees who work with the hospitals in both Cambridge and Boston. Those individuals, now we are up to about 26 individuals who have been vaccinated in terms of this process.

Jeffrey Levine: Let's talk a little bit about the vaccination process and the pre-event phase. Who is actually going to give the vaccinations to the hospital and community response teams?

Ms. Ridley: Right. It actually, it appears to start with DPH vaccinating the core State public health staff. Then we will be vaccinating individuals in each of the hospitals. Then they will individually be carrying out the vaccination within their own hospital or networks of hospitals.

In the community-based system, we are actually going to be hiring a vendor to actually do the community-based response team. They include some of your emergency first responders, fire, police and other community-based responders. So we are actually going to have vendor-operated clinics for those individuals.

Jeffrey Levine: This is all getting a little complicated here but you mentioned something about a Phase 2 in the pre-event plan. Does Massachusetts have a Phase 2 plan and if so what is it?

Ms. Ridley: It is probably one of the most controversial questions we have had to face. We don't have the specifics on paper for the Phase 2 plan. However, there are general concepts. If we move to Phase 2 of broader vaccinations, it will involve approximately 120,000 health care workers and first responders in Massachusetts. One of the things that is very important to stress is that moving to the next phase, the Phase 2, is very dependent upon the lessons learned in Phase 1. We were very pleased to see the report that came out last Friday from MMWR that shows that the program so far has been very successful with very, very small numbers of even minor adverse reactions. We think that is what is necessary to proceed to Phase 2.

Jeffrey Levine: As we were discussing a little bit before with Dr. Raub, there have been some controversies that have come up surrounding the pre-event vaccination plans. Can you tell us a bit more about what these controversies are and how they are being addressed in your State, Massachusetts?

Ms. Ridley: Very quickly I think the next two slides will summarize the issues everyone is facing. Liability has been pretty much taken care of by the Federal law, by Section 304. Worker's compensation, because worker's compensation in our State does not kick in until about the fifth day, the issue has been who is going to cover the first five days? Many of the larger employers, we are finding in the Commonwealth, have been coming forward and have said that rather than having the individual take their own time that they will be covering those first few days. Malpractice coverage has been an issue on the table. Health insurance coverage, which Bill mentioned, for side effects. Every insurer, health insurer we have talked to, managed care plans, indemnity plans, have said no problem. They will be covering side effects for both vaccinees as well as any contacts. The issue of furloughs we have talked about. Unions have come forward and are playing a big role. It is essential to keep them in the loop and communicate with them.

The next slide shows some of the other issues. Vaccine safety, we got a lot of comments about is this the strain that is being used here in the U.S. as safe as or more safe or less safe than the strain in Israel? Actually the strain we are using here in the United States is safer, it is less reactogenic, and it doesn't cause as many reactions as the strain that was used in Israel, which is good. The safety of the bifurcated needle. That has been an issue too because obviously in this country we have tried to go toward safety needles. The bifurcated needle is not exactly that type of a needle that we are used to in health care today. However, it is the needle for which the vaccine has been standardized and we feel it is critical that we use the standardized product. We understand there are products under development.

There are additional issues. The difference between municipally-based versus private first responders, the ambulance companies, dissemination of training materials was delayed in the beginning and was repeatedly being revised and that was causing confusion and we are very concerned about the sustainability of State bioterrorism initiatives. It is a costly process and even in the hospitals this is not a one-time shot. The initial vaccinations will have to be maintained on a long-term basis so we have sustainability that is an issue.

Jeffrey Levine: Now switching from your pre-event plan to the post-event plan, how do your two plans differ and are the controversies surrounding them the same?

Ms. Ridley: If the pulse of that plan is triggered, it is a very different issue. The world as we know it would change. A lot of the questions have comments as to what is going to trigger a post-event? Is it one case in the world? Is it one case in the United States? That I think is still a very valid question. It is essential, this is the one thing we know, it is essential that we have the 10,000 individuals vaccinated should we need to proceed to a post-event plan. We are going to need every single one of those individuals to be able to vaccinate 6.5 billion residents within the 3-5 day time period. So it is absolutely essential that we move through Phase 1 and potentially also Phase 2 as quickly as possible.

Jeffrey Levine: Let's hope there is never a Phase 2. Thank you, Nancy.

I would like to ask Eddie Gabriel, Deputy Commissioner for Preparedness of the New York City Office of Emergency Management to discuss any issues that arise at the local level in addressing preparedness.

Eddie Gabriel: Well good afternoon. We can tell you that the incident management system that we have in place to prepare for this is a language. I think that one of the issues we need to think about both from a local perspective is that we get people into a room and begin to talk to each other. Incident management is really just a way by which local emergency authorities sit and talk to each other, whether it be emergency response personnel such as fire and police and ambulance personnel, emergency medical services along with the hospitals that are now using the incident management systems to coordinate their activities and response as well as the local public departments of health in our community talking together. It is a way to bring everybody to the table and get them to speak the same language. We think in a post-event that we really need to talk the same language. Otherwise you won't be able to manage the issue appropriately.

Second of all, the way by which these particular bridges, incident management is used as a bridge to bring those people to the table so people get to know each other. It is important that people know each other at the local level on a first-name basis, face to face. We think incident management is the way to go to get that to happen.

Jeffrey Levine: Now, in your opinion, should the traditional field emergency response communities such as the emergency medical system, the fire department and others be considered for vaccination during Phase 1 of the smallpox vaccination program?

Mr. Gabriel: Well I think that many of the emergency services systems across the country are asking exactly that question. I think that many of the emergency medical services systems are saying why aren't we included in Phase 1? Why aren't we being considered? I think some of that is knowledge and some of that is education. There are parts of the country where they are being included in the initial Phase 1 of the program. That is important. Again that goes back to the premise by which that agencies such as emergency field response people were traditionally not considered in the hospital and the public health community as a team. In this particular case I think it is vital to get them all to consider each other as part of the same emergency response team.

So to be more direct with that answer, I think it is important at the very least to educate those people and bring them into the fold now. On a broader perspective consider them for vaccination in the initial phase.

Jeffrey Levine: In the event a smallpox case is confirmed, how do we prevent all areas of the local government and the health care system from breaking down during a crisis? Are we protected? Human resource components, including emergency medical technicians, paramedics, nurses, doctors, police, firefighters, etc.?

Mr. Gabriel: Well, I think that when you look at the system at a local perspective, the thing that needs to be thought about is that health care systems by themselves are not islands by themselves. That they in fact count on sanitation to pick up their garbage and they count on security from the local law enforcement and they count on emergency medical services to bring resources to their institutions. They count on having their own personal staff, their physicians, their nurses, their technicians, any of the hospital personnel coming to work so you need transportation and all those things to sort of operate during this particular crisis. Especially in a post-event scenario.

So when we talk about managing these cases, we need to not look at health care specifically, a one patient-one contact scenario. You need to say to yourself, "How do I make the whole system operate? How do I make sure that essential services operate during a crisis?" The way to do that is to make sure that local government includes all those agencies together when they do their planning for this. That they are not exclusionary, that they are inclusionary.

Jeffrey Levine: Now, in the event that something like that should occur, what are the multi-agency coordination issues that need to be considered for effective local response?

Mr. Gabriel: Clearly it is a public health decision-making circumstance. The local public health, as well as the State and Federal partners, but primarily local public health will work on managing the cases and make those decisions that need to be made relative to how patients are cared for. However, the rest of city government or the rest of local government needs to go on. To do that we can open an emergency command post or command center to bring those agencies together, to sit them in a room to help make those decisions. You can make sure that if you have got a failure or a weakness in one part of the system that some way in this coordinated effort using agencies from all different city, State and Federal resources in one room can make you answer the call when it has to happen. For example, the moving of supplies of vaccine when it gets into a location to be distributed to a location is going to require transportation resources. How do you make that happen? Well you can't do that without having mechanisms in place to do that. You can't do that if the roadways aren't clear. You can't do that without security to transport those resources from one place to the other. So it is up to the localities to build those approaches into their plans to make the system work effectively.

Jeffrey Levine: If mass vaccinations are considered in response to such an event, obviously informing the public is crucial. What are the key components of a coordinated response there at a State, Federal and local level?

Mr. Gabriel: I think our experiences from September 11 have taught us a lot about this. I think the issue of one voice, one message, getting the public information community together to sort of review that message so that everyone speaks the same language. Whether or not that direction on what needs to be said comes from the Federal level or whether or not it comes from the local level, you need to make sure that the answers are coordinated; that you don't have one local authority saying one thing and a State authority saying another thing and a Federal authority saying another thing. You can do that a lot of different ways. You can get the localities, the State and the Feds together now to put together a public information sort of strategy in case that unfortunately does occur and we get a smallpox case someplace.

The other way to do it is to make sure that you reel in, if you will, some of the local people that are responsible for getting the messages out to make sure that they have their ducks in a row so that the message they send out is consistent from agency to agency to agency, all at the local level, the State level and the Federal levels. If we don't do that you will have an expert on television saying this is what is going to happen. This is how it is going to happen. And you have no control over that expert if your own locality or your own State level or you are a Federal-person who is doing the talking, give different messages.

Jeffrey Levine: Eddie, thank you very much. Now we turn to Nathaniel Hupert, Assistant Professor of Public Health and Medicine at Weill Medical College at Cornell University to discuss his work on the development of some interesting guidelines and interactive tools that State and local planners can use to design and staff vaccination campaigns.

Nathaniel, I understand you have been working on a project funded by the Agency for Healthcare Research and Quality to develop guidelines and tools that are designed to help State and local planners develop smallpox vaccination plans. Can you tell us more about this project and describe what you have been working on? I know it is very elaborate. I have seen it.

Nathaniel Hupert: Thanks, Jeff. We have been working with the Agency for Healthcare Research and Quality since 2000 on some of these projects, but specifically I will talk to you about one that we started in September 2002. Over the course of the previous year, a number of studies have come out suggesting that in certain cases, for example, if a large smallpox attack were to occur, we would need very large-scale vaccination. This really is one of the most logistically difficult tasks that a public health authority could be faced with. What we tried to do was come up with some guiding questions, some written guidelines and then some models to help the planners do this.

Really, there are three guiding questions. The first is what are the critical components of a mass vaccination campaign? I say mass vaccination to distinguish it from for example the Phase 1 campaign that Nancy talked about. Second, what role can spreadsheet models play in forecasting some of the resource requirements for mass vaccination campaigns? Finally, what are some of the limitations of these computer models in developing the actual mass vaccination plans?

The diagram that we can show you on the Internet is one of the products that we have got in these guidelines. Really the key, if you just look at the pink boxes, is that what we have tried to come up with is a straightforward way of representing the complexity of this process. For example, to suggest that there are people, that is under the "who". There are things that need to be developed, that is under the "what". There are places where this has to occur, under the "where". There are triggers for mass vaccination to occur. That is under the "when". Finally there is the question of how do you bring this all together in an operationally realistic plan?

The operations are really what I will go into in terms of some of the modeling that we have done. So over a year ago we, at Cornell University, provided some modeling expertise to New York City, to the Office of Emergency Management and to Eddie and also to the Department of Health at New York to help model what would happen at an antibiotic distribution site. You will see a cartoon of this distribution site. It is very straightforward to come up with a plan of how people would walk through a vaccine clinic.

Now what you can do once you come up with an idea of how people would walk through something like this, you can make a schematic diagram of what the actual patient flow would be through each of the different stations. For example, a triage station is an evaluation station and then a dispensing or a vaccination station. Once you have a view of what the schematic is, there are actually a couple of techniques that have been developed over the last twenty years in operations research, to turn that into a computer model. One of the most straightforward ways of conceiving this is that if you have a clinic, one of the ideas is that it doesn't continuously back up. If you start vaccinating on day one, by day ten you wouldn't like the lines in the vaccination clinic to keep backing up. You can actually come up with a formula that tells you how many staff you have to have at a given station, say at the vaccination station in your clinic, to handle a given amount of patient flow in a certain amount of time. With that formula, which is now put up on the screen, you can simply make a calculation and then do that calculation over and over again for all the different stations in your clinic.

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