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 Hearings: Testimony this is an invisible spacer image
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 STATEMENT OF
LAWRENCE R. DEYTON, MSPH, MD
CHIEF CONSULTANT, PUBLIC HEALTH
DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE
HOUSE VETERANS’ AFFAIRS COMMITTEE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
DECEMBER 15, 2005

Mr. Chairman and Members of the Committee, thank you for the opportunity to be here today to discuss the activities taken by the Department of Veterans Affairs (VA) health care system related to seasonal and pandemic influenza preparedness. As you know, Mr. Chairman, VA runs the largest integrated health care system in the Nation and provides health services to over 7 million enrolled veterans. The Centers for Disease Control and Prevention (CDC) estimates that seasonal influenza leads annually to 200,000 excess hospitalizations and 36,000 deaths in this country. The elderly and individuals with chronic medical conditions are especially vulnerable to influenza related diseases and death. This is significant because veterans using VA health care services are older and have more chronic medical conditions than the average American. Influenza vaccination is therefore one of our highest public health priorities and important preventive health programs. To that end, VA has established a seasonal influenza vaccination program that, frankly, Mr. Chairman, is unequalled in effectiveness by any public or private integrated health care system.

On November 1, 2005, President Bush announced the National Strategy for Pandemic Influenza. This strategy highlights the importance of the Nation preventing, recognizing, and preparing for, such a possible major public health problem, which could have far more serious consequences than seasonal influenza. Pandemic influenza is currently an uncertain threat – we do not know where it will strike, we do not know when. But based on the history of influenza, we believe it will. And because veterans and VA health care facilities are located in nearly every community in the Nation, we liken VA to a fine-meshed sieve when it comes to infectious diseases and public health threats – if it happens anywhere in our Nation, veterans will be affected, and VA facilities will respond.

I am pleased to report to you on the VA seasonal flu vaccination program and its effectiveness as well as on VA’s efforts to prepare for a possible influenza pandemic.

VA’s Seasonal Influenza Vaccination Program

Mr. Chairman, the annual VA seasonal influenza vaccination campaign is composed of five interrelated system-wide activities, which I will discuss in brief.

• Annual Under Secretary for Health Influenza Vaccination Directive

Each fall, the Under Secretary for Health issues a national Influenza Vaccination Directive that articulates VA’s vaccination policy for staff and patients. Under the Directive, each VA health care facility Director is required to implement a local vaccination program consistent with the guidance set out in the Directive, including special target groups. (In 2004-2005, the focus was to increase vaccination rates in racial and ethnic minorities. In 2005-2006 it is vaccination of all health care facility staff, along with veteran vaccination.) As part of their local programs, Directors conduct active and energetic flu vaccination programs, naming flu coordinators, setting local goals, and acting on that year’s national strategies. I have provided your staff with a copy of the 2005-2006 Under Secretary for Health Influenza Vaccination Directive.

• Annual national high-profile flu vaccine campaign and toolkit

Each year, VA launches a system-wide annual flu vaccine campaign that provides VA health facilities with the resources needed to organize, promote, publicize and carry out local flu vaccine programs throughout the flu vaccine season. As part of the campaign, VA Flu Vaccine Toolkits are developed and distributed to every VA health facility in the country. These tool kits are evaluated by staff surveys for effectiveness and improved, as needed, to help VA vaccinate as many enrolled veterans and health care facility staff as possible. I have also provided a copy of the toolkit to your staff.

• Timely purchase and distribution of flu vaccine supplies

Every January, VA solicits bids from vaccine manufacturers for the provision of influenza vaccines for the VA health care system in the upcoming flu vaccine season (October thru March). These contracts are signed each spring. Each October distribution of the vaccine begins to VA facilities, with rolling deliveries continuing through the fall and early winter, usually ending in December.

Over the last 8 years VA has steadily increased the amount of influenza vaccines it has purchased, based on past and anticipated needs and allowing for a small surplus. For the 1998-99 flu season VA bought less than 1 million doses; for the 2005-2006 flu season VA bought 2.24 million doses at a cost of $18.4 million.

• Provision of ongoing guidance during each flu vaccination season, as needed, to provide new information

Every flu season has its own unique issues and problems. For example, the year before last, increases in influenza cases occurring early in the season coupled with highly publicized deaths drove demand for influenza vaccines beyond capacity in many areas of the country. Last year, there was a national shortage of influenza vaccine because the vaccine supply expected from one major manufacturer was contaminated and could not be used.

We therefore provide ongoing guidance to the field and to veterans concerning any significant change in, or new information affecting, the influenza vaccine program. This guidance is in the form of timely Under Secretary for Health Flu Vaccine Advisories. Indeed, seven advisories were provided last year (between October and February) on a wide array of pertinent topics, such as updates on supply status, definitions of vaccination priority groups, recommendations on the use of antiviral medications and late vaccination. Already this year, we have distributed three advisories. Our front-line staffers inform us that these targeted advisories provide valuable and timely information.

• Establishment of VA-wide flu vaccine performance measures to which regional and local facility directors are held accountable.

VA’s commitment to the national influenza vaccination program is reflected in the fact that rates of influenza vaccination are included as VA-wide performance measures for health facility directors and network directors. Specifically, the performance measure requires influenza vaccination for veterans over the age of 50 and for veterans at high risk of complications from influenza regardless of age. Acceptable levels of performance are based on levels achieved in the previous year, and are set to drive facilities to achieve ever higher performances.

The results of our influenza vaccination program are impressive, and, as I will demonstrate, are better than all other government and private sector results for which there is data. The VA-wide rate of influenza vaccination (documented through abstraction of medical charts) for the 2003-2004 influenza season was 75% and 75% again in the 2004-2005 flu season despite problems with vaccine shortages. By another measure, self-reporting by veterans, the VA rate for vaccination of patients over the age of 50 was 71% in 2004-2005.

In contrast, the non-VA self-report rates by a CDC phone survey of adults over 65—a high risk group much more likely to be vaccinated than those over 50—showed only 68% for 2003-2004 and 63% for 2004-2005, the year of the shortage. A survey of the Medicare population (also over 65 and with the added advantage of flu vaccine coverage) showed rates nearly identical to the VA rates for those over 50. VA also outperformed other groups as seen in data from the CDC that showed commercial insurance plan flu vaccination rates for ages 50-64 to be only 52% in 2003-2004, dropping to 28% in 2004-2005.

We are extremely proud of the success VA has had in seasonal influenza vaccination. Nonetheless, there are areas where improvement is needed. VA is working hard to promote optimal vaccination rates among our health care facility staff. They are both at risk of exposure and at risk of transmission of influenza to other employees or their patients. Particularly in times of vaccine shortage, we have found some employees will forego their own vaccination in order to assure adequate supply for our patients. We have therefore put an emphasis on increasing health care staff vaccination rates, while maintaining or increasing our excellent rate of vaccination of patients.

Most importantly, assuring adequate supply of seasonal influenza vaccine itself requires stabilization of the national influenza vaccine manufacturing capacity. Thus, VA strongly supports the President’s proposal, as articulated in the National Strategy for Pandemic Influenza, to create capacity for annual influenza vaccination for every man, women and child in America.

VA Pandemic Influenza Preparedness

VA leadership has been concerned about how to minimize the impact pandemic influenza might have on the veterans we serve, on VA staff, and on vital VA systems that enable us to provide our services. Consequently, VA began to take specific steps in the summer of 2004 to protect veterans and the VA health care system from pandemic influenza.

VA’s pandemic influenza planning efforts are supported by VA leadership at all levels and are being carried out by engaged and empowered VA staff. VA’s pandemic influenza preparedness program is comprised of eight distinct and interrelated activities that I will describe.

• Use of the annual seasonal influenza vaccination campaign, both to prevent seasonal flu and to serve as a foundation for our pandemic flu efforts

The VA’s well-established proactive seasonal influenza vaccination program, just described, is essential to prevent unnecessary illnesses in our patients and staff and is also the foundation of leadership, cooperation, communications, policies, procedures, and systems upon which we are building our pandemic preparedness. This annual program is accomplished from the top down as well as from the bottom up. We actively communicate with eight categories of front-line staff--at every VA medical center nationwide about influenza and vaccination. These categories are flu coordinators, occupational health clinicians, prevention coordinators, infection control professionals, public affairs officers, patient educators, patient safety officers, and staff education contacts.

• Establishment of a stockpile of the antiviral drug oseltamivir (Tamiflu ®) and a distribution policy

Oseltamivir is an antiviral drug licensed for treatment or prevention of certain common types of influenza. It may be effective in treating or, in some cases, preventing the current strain of avian influenza (H5N1) now causing disease in birds and other animals and sporadically in humans in Asia. An influenza pandemic could result either from mutation of this H5N1 strain or from the genetic reassortment of the H5N1 strain and a human strain of influenza virus; or from mutation or reassortment of another strain of influenza. Therefore, in the fall of 2004, VA purchased 5.5 million capsules (550,000 treatment courses) to establish a VA stockpile of oseltamivir. This quantity is based on the supply needed for treatment of a total of 550 patients and staff and prophylaxis of a total of 5,000 patients and staff at approximately 25% (about 40) of our medical centers. The VA oseltamivir stockpile will be made available via seven geographically diverse distribution centers and is held for use for response to pandemic influenza in accordance with a plan approved by the Under Secretary for Health and carried out in concert with the national planning efforts.

• Initiation of a research study to extend the effective supply of oseltamivir

Oseltamivir is a drug for which there is a world-wide shortage. To make the best use of VA’s limited stockpile of this drug, VA public health leaders and researchers have initiated a study to see if the supply of oseltamivir can be extended by co-administration with probenicid. Probenicid is a drug already used in several medical situations to slow elimination of other drugs in order to achieve an improved therapeutic profile. This study has been approved for conduct by the FDA and has just been approved by VA’s Office of Research and Development. If the co-administration of oseltamivir and probenicid is found to be safe and effective, then the results of this study could have a significant impact on the Nation’s ability to use oseltamivir.

• Development of a Respiratory Infectious Disease Emergency Plan for VA facilities

In the last 4 years, VA has mounted responses to respiratory infectious disease challenges, such as anthrax events in 2001, smallpox vaccination, SARS, seasonal influenza vaccine shortages, and now pandemic influenza. Many of the preparations and responses needed to manage those challenges are relatively similar regardless of the pathogen causing the emergency. Thus, VA has developed a Respiratory Infectious Disease Emergency Plan for Facilities that is an appendix to the VA Emergency Management Guidebook. This plan is a compendium of information, guidance, and resources for VA facility directors and chiefs of staff. It articulates the preparations, planning, responses, and follow-up actions needed to manage a pandemic from a variety of perspectives, i.e. communications, education, staffing and human resources, environment/facility/equipment, and patient care management. This Plan, and other VA pandemic flu information, is posted at www.publichealth.va.gov/flu/pandemicflu.htm.

• Active participation in White House, national and HHS planning activities and development of a VA-specific pandemic influenza plan of operations

The Department has been a full participant in the U.S. Government-wide planning and response activities led by the White House and the Department of Health and Human Services (HHS). These discussions have been conducted under the auspices of various Federal leaders in HHS in the National Vaccine Program Office, CDC, and a Policy Coordinating Committee sponsored by the White House Homeland Security Council. Through this interagency effort, VA with other Federal agencies has sought to better understand the threat of pandemic influenza and the specific potential problems/challenges that would be posed by such a pandemic, particularly in the areas of public health, surveillance, medical response, vaccine development and antiviral drug supply, communications, and continuity of operations. These efforts culminated in the President’s National Strategy for Pandemic Influenza mentioned previously.

The President has also charged a group of agency representatives to develop a draft national pandemic influenza plan that will provide guidance for implementation of the President’s National Strategy and elaborate the roles and responsibilities of Federal agencies as well as that of state and local agencies, the private sector, and individuals. VA’s clinical and management expertise is heavily involved in assisting with the development of this national plan, which is due to be completed by January 1, 2006.

In addition, the President has directed each Federal agency to develop an agency-specific pandemic influenza plan using the national plan as a template. The VA plan is due by February 1, 2006, and I am pleased to report that VA’s plan is well along in development.

• Necessary improvement in timely reporting of VA patients seeking medical treatment with illnesses suggestive of influenza, with the goal of providing real-time clinical data to CDC surveillance for US influenza-like disease.

A crucial component for an optimal nationwide response to a pandemic influenza is rapid and accurate surveillance that will alert our public health authorities as soon as possible of an outbreak. VA’s national health care system, existing in every state and territory in the Nation and utilizing a fully deployed electronic medical record and reporting system, can provide important surveillance information. Thus, VA has requested resources to support application of commercially acquired software to allow the agency to do real-time reporting of influenza syndromic activity directly to the Centers for Disease Control and Prevention. This software will be part of a system already being built to improve VA’s surveillance of health care-associated infections that will also be reporting directly to the CDC. These resources are part of the President’s pandemic flu preparedness budget request currently pending in Congress.

• Development and ongoing promotion of “Infection: Don’t Pass It On,” a VA campaign to engage staff, patients, and visitors in preventing transmission of infection

Even in the absence of an effective vaccine against pandemic flu or sufficient supplies of antiviral drugs, there exist public health strategies that will lessen the risk of a respiratory infectious disease like pandemic influenza. Essentially, the common sense approaches that our parents taught us really work: wash your hands, cover your mouth when you cough, and stay home if you are sick.

VA is very proud of a public health campaign that we developed as a result of our work on SARS in the spring of 2003. Improving hand and respiratory hygiene in VA became an educational priority (launched, along with VA education materials, in fall 2004) with other themes added over time, and an overall call to action – “Infection: Don’t Pass It On.” Flu prevention was incorporated into the campaign in spring 2005.

The purpose of this public health campaign is to educate all staff, patients, and visitors throughout the VA health care system, about basic, common sense steps they need to take to prevent infection. We believe this is an essential aspect of preventing “regular” infectious diseases, such as seasonal flu and health care-acquired infection, as well as infectious disease emergencies, particularly pandemic flu. Indeed, widespread use of such effective public health measures may buy us the time we need to deal effectively with a pandemic.

To date, about 100 educational posters and other materials have been developed, including some in Spanish. The majority of them address hand-washing and respiratory hygiene, but we have also prepared materials, particularly posters in English and Spanish, to show the correct use of personal protective equipment. Please see our Web site at www.publichealth.va.gov/InfectionDontPassItOn/ for a lot of colorful information about our campaign.

The materials on hand-washing and respiratory hygiene have been widely disseminated to VA health care and long-term care facilities. These four-color posters range from serious to humorous, are targeted to clinical or all audiences, and are designed to be rotated and used repeatedly. Articles on the campaign have appeared in national and local VA publications and information about the campaign has also been presented at local and national medical conferences. Not only has the material has been distributed across the VA system, it has been used by local and state private health care providers, Department of Defense health care providers, and other countries, including Wales and Australia. Importantly, we continually solicit feedback on how we can improve our messages, materials, and approaches. Thus far, results of a national VA Web survey have shown that staff throughout the VA health care system have heeded our message to improve their hand hygiene.

• Planning of an operational tabletop exercise on pandemic flu conducted with several VA sites and in concert with Federal, state, and local agencies to focus on patient flow, employee needs, and system functionality designed to improve our national plan.

We all have learned that even excellent plans need to be tested. Once the VA-specific pandemic influenza plan is completed, VA will conduct a series of simulation exercises to test how it may be implemented to protect the veterans for whom we care and our employees as well as to ensure continuing of healthcare operations. Because VA facilities are located across the Nation, the VA simulation exercises will involve both state and local health officials with whom VA would need to coordinate in the event of a real pandemic influenza. It will also involve other Federal agencies, such as the Departments of Homeland Security, Health and Human Services and Defense.

In summary, VA has an active and successful approach to seasonal influenza and has begun to apply that approach to the possibility of pandemic influenza. Large health care organizations, like VA, have special responsibilities to have plans in place that will afford patients and employees the best possible protections against disease and its consequences and continue health care operations. We are pleased with the actions VA has taken to date that have started us down the path of preparedness for pandemic influenza. It is a long and not always easy path. Nonetheless, I assure you VA will continue to take whatever actions are needed to protect our veterans and employees and the VA health care system against seasonal influenza by continuing our annual program as I outlined and learning how to continue to improve it. We will also continue strong efforts to prepare VA for pandemic influenza as we fully implement the National Strategy outlined by the President. VA will be there for the veterans who rely on us for their health care.

More information on VA, flu, and pandemic flu--and the tools we are using to fight these diseases--is available at www.publichealth.va.gov/flu.

This concludes my statement. I will be pleased to answer any questions. Thank you.
 

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