Hospital-Based Planning

The Department of Health and Human Services has recommended that hospitals and health care providers develop a plan for a moderately severe influenza pandemic, such as the ones that occurred in 1957 and 1968, and a second plan for a more severe experience, such as the one that occurred in the 1918–1919 pandemic. However, the US health care system is not currently able to respond to a pandemic effectively [11, 12], for the following reasons:

1. It consists of an uncoordinated, fragmented, and largely private system. It is broke or nearly broke, with one-third of hospitals operating at a deficit.

2. There are severe manpower shortages, especially in nursing, with an estimated current need for ∼100,000 nurses (representing ∼8% of the nursing workforce).

3. Approximately 48% of emergency departments operate at capacity or over capacity.

4. The number of hospitals, emergency departments, and intensive care unit beds is decreasing.

5. Essential health care supplies might not be available during a pandemic, because health care systems maintain their supply chains with “just-in-time” operations, and ∼80% of supplies, including drugs, come from offshore suppliers, which themselves might not be functioning during a pandemic.

The Center for Biosecurity of the University of Pittsburg Medical Center used FluSurge 2.0 (a modeling tool from the Centers for Disease Control and Prevention [CDC]), with input variables as recommended by Department of Health and Human Services planning scenarios, with the assumption of a 25% attack rate and a pandemic lasting 8 weeks [11, 15, 16], to calculate bed and ventilator demands (tables 2 and 3) [11]. Table 2 shows the estimated demand (as percentage of current capacity) for 90 million infected persons, including 45 million who would seek care over an 8-week period. Table 3 provides calculations that include a “multiplier,” indicating the increase in demand, compared with that of the 2005–2006 seasonal influenza. The results show daunting requirements for a system that is shrinking and already operating at capacity. The Center for Biosecurity of University of Pittsburg Medical Center further concludes that hospital preparedness is seriously underfunded, because the projected need is nearly $1 million per hospital (table 4).

The Center for Biosecurity of University of Pittsburg Medical Center recommends that hospitals undertake the following actions [12]:

1. Form a pandemic preparedness committee, with a full-time, dedicated disaster coordinator, to undertake comprehensive and realistic planning in coordination with regional hospitals and public health officials. FluSurge 2.0 can be used to guide planning [6]. Hospitals should aim to make 30% of beds available within 1 week, double the licensed bed capacity within 2 weeks, and anticipate supply needs (including medications).

2. Focus on methods to limit nosocomial spread: (1) stockpile a 3-week supply of surgical masks, with anticipated use by everyone in the facility, and N95 respirators for use by health care workers; (2) prevent infected staff from working; (3) limit exposures by cohorting patients; and (4) improve hospital surveillance.

3. Maintain and augment the health care workforce: (1) make rapid influenza testing readily available; (2) treat with antiviral agents within 6 h of symptom onset, (3) organize in-home child care in the event of school closures, (3) maintain open and honest communication, (4) expand occupational health services, (5) provide training to staff, (6) develop plans to augment clinical staff, and (7) coordinate activities with other region hospitals.

4. Allocate resources efficiently: (1) prioritize services; (2) establish clinical care guidelines; (3) address legal and ethical issues, such as rationing care and prioritization for antiviral agents, vaccine, ventilators, and beds; (4) develop a framework for the fair and efficient allocation of antiviral agents and vaccine; and (5) provide credible communication to health care personnel and the public.

State-Based Planning

The US federal government has led substantial efforts to develop a pandemic influenza plan but made it clear that the ultimate responsibility for health care and pandemic influenza planning and implementation is largely state based [7]. Planning should be based on the following assumptions: an attack rate of 30%, use of outpatient facilities for care for 50% of patients with influenza, an incubation period of 2 days, a basic reproductive number (R₀, defined as the average number of secondary infections generated by 1 patient) of 2.0, duration of local outbreak of 6–8 weeks, and a severity of illness and mortality that will depend on the influenza strain [5]. Holmberg et al. [10] reviewed the plans for 49 states [9] in late 2005 and early 2006, with several conclusions. All states were basing the prioritization of pandemic influenza vaccine in accordance with recommendations issued by the Advisory Committee on Immunization Practices for seasonal influenza. Although all states planned to rely on the National Sentinel Physician Surveillance System, which records mortality for pneumonia and influenza-related deaths for 122 cities, only 12 states were planning real-time syndromic surveillance of influenza-like illness, and only 8 planned screening of incoming international travelers. For containment measures, most states had no specific plans for nonpharmacological community mitigation measures, and those states that did have a plan showed remarkable heterogeneity of considered interventions, such as voluntary personal isolation in 17 states (35%); possible closures of schools, businesses, and institutions in 18 states (37%); and institutional or household quarantine in 15 states (31%). Twelve states (25%) planned for vaccination or antiviral prophylaxis of contacts. Holmberg et al. [10, p. 1417] concluded that the plans at the time of the review in early 2006 resulted in a “patchwork of plans that will not adequately detect or control this or other respiratory disease pandemics.” Specific concerns were the lack of a vaccination strategy to limit the pandemic spread, surveillance plans that are unlikely to detect a local outbreak within 2 weeks of its onset, and confusion about the use and practicality of implementing community containment measures, such as social distancing. The authors emphasized the need for further guidance by federal authorities, which was subsequently addressed by the February 2007 issuance of the CDC's Guidance on Community Mitigation, reviewed below.

CDC Interim Prepandemic Planning Guidance: Community Strategy for Epidemic Influenza Mitigation in the United States [8]

This CDC document addresses the use of nonpharmacological containment interventions for pandemic influenza, with the intention of broadening the epidemic curve, decompressing the intensity of demands on the health care system, and, ultimately, reducing mortality [8]. The recommended strategies are focused largely on social distancing, to achieve a reduction in transmission rates, and are supported by data derived from mathematical modeling [19–21] and analysis of the 1918–1919 pandemic [22–25]. The document states that the proposed mitigation strategies should be implemented on the basis of the severity (table 5) and on the World Health Organization stage of the pandemic (tables 6 and 7), which are summarized in table 8. Specific recommendations include the following:

1. Isolation at home or in the health care setting, depending on the severity of illness and the capacity of the health care system.

2. Voluntary home quarantine of uninfected contacts, combined with prophylactic antiviral agents if there is a sufficient supply, an adequate distribution system, and activity against the pandemic influenza strain.

3. Closure of schools, including colleges, universities, public and private schools, child care programs, and other places of community mixing.

4. Closure of businesses and cancellation of public gatherings to the extent possible without disrupting essential services.

5. Education about and implementation of infection-control measures, such as cough etiquette, hand hygiene, and use of surgical masks or N95 respirators.

The Center for Biosecurity of University of Pittsburg Medical Center raised questions about the CDC guidance [14]:

1. Are predictions by mathematical models sufficiently accurate to render policy recommendations of this magnitude? The data available to parameterize the models are limited, and the models may not accurately predict public response or capture the indirect consequences of interventions.

2. Are these interventions feasible? The experience in Toronto, Canada, with severe acute respiratory syndrome is cited as an example. The implementation of home quarantine was prodigious, in terms of informing, convincing, and feeding a population that was told to stay home [26].

3. What are the potential unintended consequences? For example, school closure to achieve social distancing would require closing cinemas, malls, and other places of community gathering, to prevent the population from mixing in alternative venues. School closure would sacrifice some vital services, such as the school lunch program, which feeds ∼30 million children, and would result in substantial losses in wages for working parents.

4. Large-scale quarantine may be impossible to enforce and has not been used effectively to control any disease for the past 50 years. The World Health Organization states that “if such measures are to be effective, they must be very severe” (cited in [27]).

Lessons from severe acute respiratory syndrome and perceived risk of influenza pandemic. The experience with severe acute respiratory syndrome may provide insight into the consequences of a global pandemic. Even though severe acute respiratory syndrome was limited geographically and <10,000 people were infected, the economic losses were estimated to be $30–$100 billion, and the impact on nonhealth sectors greatly exceeded the direct health effects [28]. A recent survey of public health professionals in the United States indicated that approximately one-half would avoid work as well [29]. This could have severe detrimental effects on the economy and on the availability of goods and health care personnel.

The Pandemic and All-Hazards Preparedness Act. Some of the issues regarding resources and organizational planning were addressed in the Pandemic and All-Hazards Preparedness Act (S.3678), signed by President Bush on 19 December 2006 [5, 6]. The Act promotes a more coordinated and streamlined federal public health response while keeping states accountable. Components of the Act include provisions to improve national surveillance structure, surge capacity, manpower, medical countermeasures, and ethics and equity in distribution of resources. Specific components of interest are:

1. The Department of Health and Human Services is established as the federal agency responsible for coordinating response to public health and medical emergencies.

2. Grants are given to state governments to strengthen health care systems in their ability to respond to public health emergencies but require accountability with “evidence-based benchmarks” and require modest nonfederal funding supplements. Awards may be made to hospitals, clinical laboratories, and universities for improved diagnostics.

3. Surveillance is to be improved by expanded use of information technology for disease detection.

4. Workforce enhancements include expansion of (1) the National Health Service Corps of Health Resources and Services Administration (with incentives through loan forgiveness); (2) the National Disaster Medical System, which deploys teams of health care professionals and supplies to disaster areas; (3) the Medical Reserve Corps, which is a community-based program of volunteers; and (4) the CDC Epidemic Intelligence Service.

5. Grants are available for hospitals and health care facilities, to improve surge capacity and enhance community and hospital preparedness.

6. The Biomedical Advanced Research and Development Authority is established to facilitate the development of new products, such as antiviral agents, diagnostics, and vaccines. This includes authority (but, unfortunately, no funds yet) for Department of Health and Human Services to support the development of products across “the valley of death”—the gap in funding that occurs between National Institutes of Health funding and BioShield procurement contracts.

7. A National Biodefense Science Board is established to provide expert advice to the Secretary of Department of Health and Human Services on preparedness-related issues. Participants include US government officials and members of industry and academia.

Several concerns regarding The Pandemic and All-Hazards Preparedness Act were recently provided by Hodge et al. [30]:

1. The funding requires recipients to be “accountable” and meet benchmarks, but the criteria for determining noncompliance are not clear.

2. The effort to improve surveillance to facilitate rapid response may jeopardize privacy laws and standards.

3. The use of volunteers does not address the highly sensitive liability issue.

4. Biomedical Advanced Research and Development Authority funding is considered to be an inadequate incentive for participation by the private sector, and the issue of indemnification is not addressed.

5. The Act mandates responsibility for distribution for supplies, but the ethics of allocating limited resources is not addressed.

The Infectious Disease Society of America Pandemic Influenza Task Force plans. [18] This Task Force published the following new recommendations for pandemic influenza in January 2007:

1. Strengthen pandemic vaccine efforts by establishing a multinational pandemic influenza vaccine master program.The current US Strategic National Stockpile has sufficient H5N1 vaccine for 6 million people, or 2% of the US population [7]. What is needed is increased production capacity, better antigens or adjuvants, and capacity to produce an adequate supply within 6 months of detecting a new antigentic variant. The highest priority in the Infectious Disease Society of America plan is for an influenza vaccine program on the scale of the Apollo space project (that was funded at $73 billion during 1960–1973). The United States would serve as a catalyst, with a minimum US investment of $2.8 billion in FY07, and would work with the World Health Organization and the private sector, with priorities for international partnerships, equitable global distribution, and transparency of data, to foster better and faster science. At present, the global capacity for influenza vaccine production is estimated to be 500 million doses per year, or enough for ∼8% of the global population, with production limited to 9 countries (Australia, Canada, France, Germany, Italy, the United Kingdom, The Netherlands, Switzerland, and the United States), which would give priority to treatment of populations of those countries. The sensitivity of inequitable global distribution has been highlighted by the claim of property rights by the Indonesian government for their influenza strains [31], in defiance of the World Health Organization plan for global access to avian influenza strains that could be used for vaccine and antiviral development. Indonesia and other developing countries want to be included in the plans for distribution of vaccines, an appeal that is well respected in the Infectious Disease Society of America recommendations.

2. Strengthen anti-infective pharmaceutical research and development and stockpiling efforts. The stockpile now contains enough oseltamivir and zanamivir for ∼25% of the US population, and $103 million has been allocated for new drug development [7]. A supply sufficient for the extended prophylaxis of selected populations, such as health care workers, is needed, in addition to greater support for the development of new products in this category. Funding for this effort should be facilitated by the newly established Biomedical Advanced Research and Development Authority.

3. Improved quality and availability of diagnostic tools for influenza.There is a need for improved diagnostic testing to be able to detect avian influenza at the point of care. Such a test should be simple to use, rapid, inexpensive, and globally available. A promising example is the MChip, which is low priced, easy to use at the point of care, and has acceptable sensitivity [32].

4. Update US plans for countermeasure distribution and prioritization of use.The request is for appropriate experts in ethics, technical issues, and stake holders to facilitate national guidelines on antiviral and vaccine distribution that will facilitate such planning by states. The Task Force acknowledges the prerogatives of state-based decisions but also notes that it makes little sense for 50 states to individually develop plans.

5. Protect the health care workforce during a pandemic.Health care workers are a critical component of the pandemic response but would be at substantial personal risk, both themselves and their household contacts [29]. This emphasizes the need to make health care workers a priority for protective devices, vaccine, and antiviral prophylaxis.

6. Develop and test community mitigation.There is a paucity of credible data on the merits of social distancing, such as school closures, business closures, and ring prophylaxis. The concern is the need for the 1918–1919 data to be interpreted more in light of modern conditions.

Discussion

The true risk of pandemic influenza is unknown, but there is consensus that the United States needs to be better prepared to respond to a catastrophic medical crisis. The experiences with anthrax in 2001 and Hurricane Katrina in 2006 are examples of either minor or geographically limited US events in the recent past that clearly revealed huge deficits in our ability to orchestrate a well-coordinated and efficient response, despite pre-event warnings. The major issues raised in this review are as follows:

1. The US health care system is completely uncoordinated and nearly broke; it has sharply limited bed capacity, resources, and personnel; and it has almost complete dependence on offshore suppliers.

2. Surge capacity is a substantial concern and a priority. The data reviewed (tables 2 and 3) indicate that pandemic influenza on a scale of the 1918–1919 pandemic would greatly exceed our ability to provide medical care with current standards.

3. Resource allocation to date has been ∼$7 billion, with the largest allocations for vaccine development. The amount seems spartan for ensuring a global supply of pandemic vaccine. There is consensus that a very high priority needs to be accorded to vaccine development, in terms of production capacity, nondependence on offshore production, a more “nimble” system (ability to produce adequate supplies of a vaccine to a new antigen within 6 months), and a great need for international collaboration and cooperation in both the development process and distribution. The science capacity and potential production capacity seem adequate, but we are not even close to Apollo-scale funding.

4. “Community mitigation” has brought great focus to an embarrassing paucity of basic knowledge of how influenza is transmitted and how to control it. We simply do not know the potential value or harm of “sneezing into your sleeve,” surgical versus N95 masks, or closure of schools, malls, and subways for weeks. This makes planning predictably controversial, especially when it carries substantial “second- and third-order consequences” that are so unpredictable.

5. The response of the health care system (i.e., care providers, supply chains, and emergency response issues) is critical to this effort, and there needs to be better understanding of needs and expectations.