Symposium on Pandemic Influenza - October 2007
By Zakir Hussain A. Shaikh, MD, MPH, and Mike Schwartz, PharmD
Much has been written on pandemic influenza, avian influenza, and bioterrorism, and their potentially devastating impact on the U.S. health care system. However, few articles have systematically addressed the realistic challenges facing hospitals and other health care facilities today as they attempt to develop and implement practical, workable plans for pandemic preparedness. A thorough assessment and understanding of these challenges would help channelize the planning efforts in a positive and constructive manner.
Agencies at all levels of the government have been involved in pandemic influenza preparedness planning 1,2 and have issued plans that theoretically encompass the entire gamut of organizational and community preparedness activities, including those in the hospital setting. Various other publications spell out the logistical details to be followed by hospitals and health care facilities to ensure that they are able to attain a high level of preparedness for pandemic influenza, avian influenza, and other bioterrorism threats. One such publication outlines the steps involved in the practical aspects of implementing a bioterrorism preparedness program in a hospital setting. 3 The current gap between the will to be prepared and the actual preparedness status can be explained by several challenges faced by our hospitals and health care organizations.
Lack of Financial Resources
Lack of financial resources is perhaps the biggest challenge limiting our ability to be prepared for pandemic influenza. Many U.S. hospitals today are in their greatest financial jeopardy in history, with declining total margins from increasing pressures to cut costs, indigent care, and cross-subsidies for other money-losing services. 4
More lurking threats are due to hit our health care system by 2020, when about twice as many elderly patients will be seeking health care. How can we then blame our hospital administrators for not embracing the recommendation of Margaret Chan, MD, director general of the World Health Organization, that "investing in pandemic preparedness is essentially like investing in an insurance policy. … Hope we will never have to make a claim"? 5 How can we spend six-figure sums for buying reserve stocks of mechanical ventilators, isolation supplies, and prophylactic antiviral medications when that same money can be directly used to meet our current patient care needs? Other capital improvement projects, such as overhauling our facilities, updating operating room instruments, or investing in electronic medical record (EMR) implementation, may assume higher priorities as well.
Lack of human resources would be another significant impediment to providing care in the hospital during an influenza pandemic. Besides doctors, nurses, and allied health professionals, all levels of employee staffing would be threatened. Absence from work may be caused by various reasons, including fear for individual health and safety, personal illness, voluntary or involuntary confinement following exposure (quarantine), tending to sick family members, caring for children dismissed as a result of school closures, or simply nonavailability of transportation. Forecasts predict that up to 40 percent of staff may be absent during the two-week period when the pandemic would be at its peak. 6
Hospital preparedness strategies should include the implementation of disaster credentialing and the enlistment of voluntary staff as potential workers. However, plans to use such volunteers will undoubtedly fall short of filling all of the staffing needs. Currently across the United States, 689 Medical Reserve Corps Units have 124,353 volunteers; 7 however, many of these volunteers would have job responsibilities with their primary employers during a pandemic or would not have the necessary training to fill staff positions in such areas as intensive care units.
Current lack of infrastructure and health care capacity is often highlighted during peak times of seasonal influenza or, for that matter, during busy weekend night shifts. 8 Preparedness strategies should include methods to enhance bed capacity by creating memoranda of understanding with other institutions such as nursing homes, surgery centers, long-term care facilities, and rehabilitation facilities. This strategy relies on the assumption that the alternate health care sites would be prepared in terms of supplies, equipment, staff, and training, and would be able to manage the influx of patients with higher acuity than normal for that facility. Such an implementation strategy may prove difficult, as such institutions traditionally do not maintain such capabilities. 9
Hospitals simply do not maintain the physical space to store the additional ventilators required during a flu surge. 10 Further, if the epidemic is widespread across the United States, such additional resources would not likely be available elsewhere. 11 Clearly, without such contingency capabilities, hospitals are going to be challenged with difficult decisions regarding allocation of these scarce medical resources. Operational decisions involving allocation at this level will not be made by the government, but will remain the responsibility of the individual hospital. This makes pre-event planning essential, 12 especially because recommendations now clearly state that hospitals need to prepare, keeping in mind that they will need to remain self-sufficient for up to seven days. Thorough guidance for hospital planners is available on the U.S. Centers for Disease Control and Prevention (CDC) Web site, 13 as well as from the robust reference library of the Greater New York Hospital Association. 14
Issues With Implementing a Preparedness Plan
Lessons learned from the unanticipated events during the Spanish flu, the swine flu, the severe acute respiratory syndrome (SARS) outbreak, and smallpox vaccination programs emphasize the need to plan for the unexpected. Ideally, a comprehensive plan should be developed, and all staff members involved in the implementation should be properly trained.
Furthermore, such a plan must be practiced thoroughly by drills to ensure that it will work smoothly. However, despite designing inherent and redundant fail-safe measures, the possibility of failure remains at numerous points in such a plan. Additionally, because a patient with a novel strain of influenza virus may not be easily detected, 15,16 disease transmission in the hospital is possible before detection, as evidenced in the SARS outbreak in Canada.
Limited Supply of Medications
During the 2005-06 influenza season, CDC and the Advisory Committee on Immunization Practices (ACIP) recommended against using amantadine or rimantidine for chemoprophylaxis or treatment of influenza A, 18 leaving the more expensive neuraminidase inhibitors, oseltamivir and zanamivir, as the only pharmacologic options. This recommendation remains in effect, as the seasonal influenza strains continue to demonstrate high levels of resistance to amantadine and rimantidine.
Although the Strategic National Stockpile contains 3.3 million courses of oseltamivir earmarked for the treatment of Texas residents in an influenza pandemic, and the state has stocked 144,622 courses of antivirals to be used for outbreak control, prophylaxis, and treatment of a limited number of first responders and health care workers (personal communication, John Carlo, MD, 2006), individual hospitals are expected to stockpile antiviral medicines for their staff and patients. Despite the recognition that providing antiviral prophylaxis medications is a major component of any influenza-control plan, efforts at such stockpiling have formulary, contract, and logistical, as well as significant financial, implications. Furthermore, if each institution does decide to stockpile supplies of antiviral medications, current production may not meet such demand and may likely impact availability of treatment for seasonal influenza cases. 19
Uncoordinated Vaccination Efforts
The significant shortage of influenza vaccine in the United States in October 2004 prompted CDC to recommend limiting vaccinations to groups at highest risk in a tiered manner. 20 During the past few years, vaccine distribution practices have continually resulted in vaccine shortages early in the influenza season, followed by subsequent extensive surplus of vaccines at the end of season. 21 Under the current manufacturing and distribution practices, vaccine availability for a novel strain of influenza virus would be further hampered by an increased demand, as well as a production delay of up to six months. 22
Of more concern is not knowing the exact strain of the novel virus until it becomes a pandemic, resulting in the likely possibility of the current federal funding of $1.2 billion earmarked for the purchase of H5N1 vaccines to be wasted in the event of a mismatch between the vaccine and the pandemic influenza strain. 23
Controversies of Infection-Control Strategies
The current scientific knowledge of influenza transmission and control remains controversial. Preventing the spread of influenza in health care settings would involve attempting to stop all transmission possibilities by perhaps using the most stringent mechanisms proposed for infection control for influenza, including the widespread use of respirators. 24
However, the question remains as to how practical, acceptable, and cost-effective this p recautionary approach is, especially because respirators are hard to use properly and make it cumbersome to provide routine care. A more practical and pragmatic approach would be to accept the use of surgical masks when dealing with patients with seasonal or pandemic influenza and to emphasize the use of respirators in high-risk settings of highly pathogenic avian influenza. This approach may allow continued efforts to focus on the very basic tenets of infection-control practices, i.e., hand hygiene and standard precautions.
Ethical Issues in Pandemic Planning
Pandemic influenza planning has spotlighted the ethical debate involved in the public health preparedness initiatives. 25 Innumerable principles of medical ethics are being challenged, including the need to respect individual autonomy versus proportionality to protect the larger public health interests; health care workers' duty to provide care during a pandemic versus an obligation to self, family, and friends; and equitable access versus stewardship in the rationing of supplies, medications, vaccines, and hospital beds.
One such controversy is highlighted by issues related to the pandemic influenza vaccine allocation strategy. In its pandemic influenza plan issued in November 2005, the U.S. Department of Health and Human Services (HHS) guided by the ACIP made recommendations about which age and occupational groups should have a higher priority for vaccination. The ACIP recommendations have been guided by the principle of "saving-the-most-lives" so that each person has an opportunity to live a full life. However, this has been challenged by other group of bioethicists, who suggest an alternative viewpoint of giving priority to the young and middle aged on the basis of the amount that people have "invested" in their lives balanced by the likely time left to live, as well as the need to maintain public order by emphasizing the value of ensuring safety and protecting the availability of life's necessities. 26
Another controversial issue involves the ethics of quarantine in an attempt to limit the spread of pandemic influenza and to gain time to launch our domestic pandemic response efforts.
The Next Steps
"The pandemic influenza clock is ticking; we just don't know what time it is." These words of Ed Marcuse, the former chair of the U.S. National Vaccine Advisory Committee, should serve as a reminder for us to continue our efforts for pandemic influenza preparedness despite all these challenges.
Hospital preparedness should remain the essential cornerstone for a community's planning for pandemic influenza. The decision on the extent of an individual hospital's commitment for pandemic preparedness needs to be made by top-level management and the board, taking into account the current limitations of the hospital's capabilities and resources. Each hospital should then designate a single accountable official for the pandemic preparedness initiative and incorporate mechanisms for regular reports on progress and pitfalls.
The key elements of the hospital's pandemic preparedness plan should be incorporated into the day-to-day activities to the fullest extent possible. This will require the simple, common-sense prevention practices, including hand hygiene, cough etiquette, and syndrome-based triage strategies, to be ingrained as "second nature." The framework for increasing compliance with the seasonal influenza vaccination should be emphasized at the highest level, so as to lay grounds for future vaccination efforts. The logistics of selecting, purchasing, and stocking vaccines and antiviral drugs should be integrated into the pandemic preparedness plan, so that aggressive rotation of additional reserve stock by product expiration dates prevents financial loss. Criteria should be formulated for rationing the limited resources in the event of a pandemic to include strategies for use of vaccines, medications, ventilators, and hospital beds. Pre-establishing an allocation algorithm would promote discussion in an ethical framework that would be acceptable in times of need.
Hospital employees and staff need to be seen and treated as partners in this effort, especially because they are likely to be called on to go above and beyond their normal scope of duties and responsibilities. Getting their buy-in during the planning phase will prevent confusion and distrust when dealing with difficult scenarios like rationing of the limited supply of vaccines or being asked to take care of patients who need to be cohorted for isolation or quarantine purposes.
Public forums should be held to outline the hospital's pandemic preparedness initiatives to allow an opportunity to integrate with the community and business preparedness efforts at large. Recognition is critical of the grim reality facing our health care institutions already near capacity or beyond and that a pandemic, even of a relatively low severity, will overrun the system quickly. While an easy fix to this dilemma does not seem evident, progress can be made through collaborative work among the hospitals, local health departments, civic and philanthropic organizations, business coalitions, and the community. Local health departments need to be regarded as leaders of this strategic initiative of gathering all the players to the table and for providing oversight and integration for the pandemic influenza preparedness activities.
Dr. Shaikh is the chief of infectious diseases at Methodist Dallas Medical Center and hospital epidemiologist and medical director in Infection Control for the Methodist Health System in Dallas. Mike Schwartz is associate professor at the South University School of Pharmacy and Department of Physician Assistant Studies, and practices within the Department of Primary Care Medicine at Winn Army Community Hospital in Fort Stewart, Ga.
- HHS pandemic influenza plan. Washington, D.C.: U.S. Department of Health and Human Services; November 2005. http://www.hhs.gov/pandemicflu/plan/pdf/HHSPandemicInfluenzaPlan.pdf . Accessed July 15, 2007.
- Holmberg SD, Layton CM, Ghneim GS, Wagener DK. State plans for containment of pandemic influenza. Emerg Infect Dis . 2006;12(9):1414-1417. http://www.cdc.gov/ncidod/EID/vol12no09/pdfs/06-0369.pdf . Accessed July 15, 2007.
- Shaikh ZH. Practical aspects of implementation of a bioterrorism preparedness program in a hospital setting. Infect Dis Clin North Am. 2006;20(2):443-453.
- Altman, SH, Shactman, D, Eilat E. Could U.S. hospitals go the way of U.S. airlines? Health Affairs (Millwood) . 2006;25(1):11-21.
- Pandemic flu: communicating the risks. Interview with Margaret Chan, MD, director general, World Health Organization. Bulletin of the World Health Organization. 2006;84(1):1-80. http://www.who.int/bulletin/volumes/84/1/interview0106/en . Accessed July 15, 2007.
- National Strategy for Pandemic Influenza: Implementation Plan. Washington, D.C.: Homeland Security Council; May 2006. http://www.whitehouse.gov/homeland/nspi_implementation.pdf. Accessed July 15, 2007.
- Medical Reserve Corps Web site. http://www.medicalreservecorps.gov/HomePage . Sponsored by the Office of the U.S. Surgeon General. Accessed July 15, 2007.
- Derlet RW, Richards JR, Kravitz R. Frequent overcrowding in U.S. emergency departments. Acad Emerg Med . 2001;8(2):151-155.
- Bloem K. Treating the sick: capacity of the U.S. health care system to respond to an epidemic. Public Health Rep . 2001;116(suppl 2):34-35.
- FluSurge 2.0. http://www.cdc.gov/flu/tools/flusurge . Accessed July 15, 2007.
- Hick JL, O'Laughlin DT. Concept of Operations for triage of mechanical ventilation in an epidemic. Acad Emerg Med . 2006;13(2):223-229.
- Phillips SJ, Knebel A, eds. Mass medical care with scarce resources: a community planning guide. Rockville, Md.: Agency for Healthcare Research and Quality, 2007. AHRQ Publication No. 07-0001. http://www.ahrq.gov/research/mce/mceguide.pdf .
- Hospital pandemic influenza planning checklist. http://www.pandemicflu.gov/plan/healthcare/hospitalchecklist.html. Accessed July 15, 2007.
- General emergency preparedness for providers: guidelines/protocols/checklists. http://www.gnyha.org/31/Default.aspx . Accessed Aug. 9, 2007.
- Gerberding JL, Morgan JG, Shepard JA, Kradin RL. Case records of the Massachusetts Generatl Hospital. Weekly clinicopathological exercises. Case 9-2004: an 18-year-old man with respiratory symptoms and shock. N Engl J Med . 2004:350(12):1236-1247.
- de Jong MD, Bach VC, Phan TQ, et al. Fatal avian influenza A (H5N1) in a child presenting with diarrhea followed by coma. N Engl J Med . 2005;352(7):686-691.
- Advisory Committee on Immunization Practices. Smith NM, Bresee JS, Shay DK, Uyeki TM, Cox NJ, Strikas RA. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep . 2006;55(RR-10):1-42.
- F iore AE, Shay DK, Haber P, et al. Prevention and control of influenza. Recommendations of the advisory committee on immunization practices (ACIP), 2007. MMWR Recomm Rep . June 29, 2007;56(early release):1-54.
- Joint position statement of the Infectious Diseases Society of America and Society for Healthcare Epidemiology of American on antiviral stockpiling for influenza preparedness. October 2005. http://www.idsociety.org/template.cfm?ction=home&template=/contentmanagement/contentdisplay.cfm&contentid=14970 . Accessed July 15, 2007.
- Centers for Disease Control and Prevention. Notice to Readers: Supplemental recommendations about the timing of influenza vaccination, 2004-05 season. MMWR Morb Mortal Wkly Rep . 2004;53(37):878-879.
- Elliott VS. Flu vaccine shortage now a surplus in some areas. AMNews. Health and Science. Feb. 7, 2005. http://www.ama-assn.org/amednews/2005/02/07/hlsd0207.htm .
- U.S. Department of Health and Human Services. Pandemic planning update IV. http://www.pandemicflu.gov/plan/panflureport4.html .
- President outlines pandemic influenza preparations and response. William Natcher Center, National Institutes of Health, Bethesda, Md. Nov. 1, 2005. http://www.whitehouse.gov/news/releases/2005/11/20051101-1.html . Accessed July 15, 2007.
- Centers for Disease Control and Prevention. Interim guidance for the use of masks to control influenza transmission, Aug. 8, 2005. http://www.cdc.gov/flu/professionals/infectioncontrol/maskguidance.htm . Accessed July 15, 2007.
- University of Toronto Joint Centre for Bioethics Pandemic Influenza Working Group. Stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza. http://www.utoronto.ca/jcb/home/documents/pandemic.pdf . Accessed July 15, 2007.
- Emanuel EJ, Wertheimer A. Public health: who should get influenza vaccine when not all can? Science. 2006;312(5775):854-855.
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