Appendix A
Summary of Lessons Learned from Other Mass Distribution Events

Public health agencies at the federal, state, and local levels, along with their community partners, have experienced events that involved distributing medications or administering vaccines on a large scale in the context of an actual or potential public health threat (e.g., an anticipated swine flu pandemic, an anthrax attack, fear of bioterrorism with smallpox, shortage of seasonal influenza vaccine). The committee heard presentations about these events and reviewed some of pertinent literature to determine if some lessons learned could be applied to pandemic influenza. However, the distribution and dispensing of antivirals may be significantly different from some of these events because of the nature of the disease, the scarcity of the resources involved, and the characteristics of the antiviral medications.

VACCINE SHORTAGE

Before the 2004–2005 influenza season, the Food and Drug Administration was notified by vaccine manufacturer Chiron that the British regulatory agency had suspended its manufacturing license, leading to a shortfall in vaccine production and a severe shortage of influenza vaccine (FDA, 2008). Production and distribution of vaccine are normally private-sector processes, but the creation of a public health emergency (i.e., inadequate ability to protect vulnerable groups) led public health agencies to play a larger role than usual (ASTHO, 2006). Similarly, in preparing for and responding to an influenza pandemic, the production and



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Appendix A Summary of Lessons Learned from Other Mass Distribution Events P ublic health agencies at the federal, state, and local levels, along with their community partners, have experienced events that involved distributing medications or administering vaccines on a large scale in the context of an actual or potential public health threat (e.g., an antici- pated swine flu pandemic, an anthrax attack, fear of bioterrorism with smallpox, shortage of seasonal influenza vaccine). The committee heard presentations about these events and reviewed some of pertinent litera- ture to determine if some lessons learned could be applied to pandemic influenza. However, the distribution and dispensing of antivirals may be significantly different from some of these events because of the nature of the disease, the scarcity of the resources involved, and the characteristics of the antiviral medications. VACCINE SHORTAGE Before the 2004–2005 influenza season, the Food and Drug Admin- istration was notified by vaccine manufacturer Chiron that the British regulatory agency had suspended its manufacturing license, leading to a shortfall in vaccine production and a severe shortage of influenza vac- cine (FDA, 2008). Production and distribution of vaccine are normally private-sector processes, but the creation of a public health emergency (i.e., inadequate ability to protect vulnerable groups) led public health agencies to play a larger role than usual (ASTHO, 2006). Similarly, in pre- paring for and responding to an influenza pandemic, the production and 

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 ANTIVIRALS FOR PANDEMIC INFLUENZA distribution of antiviral medications will require not only considerable public health agency involvement, but also leadership. Several aspects of the vaccine shortage are noteworthy, and some are especially relevant to antiviral distribution and dispensing. • Vaccine delivery systems vary from state to state. • Differences among health departments in prioritization and implementation created public confusion. • There was a need to prioritize initially, but the range of priority groups broadened with time as successful coverage of high-need groups allowed some flexibility in the use of remaining vaccine. However, the change in priority groups was hard to implement and communicate, and in the end, some vaccine went unused. • Some states invoked an emergency order to restrict vaccine dis- tribution to specified groups. Some states held mass vaccination clinics for target groups; others directed the existing provider infrastructure to administer vaccine only to priority groups. One state held a lottery. • The Health Alert Network was used in communication between the Centers for Disease Control and Prevention (CDC) and the states. States also used existing communication plans. • The Health Alert Network was a helpful mechanism for dis- seminating secure information, and it would likely play a similar role in a pandemic, assuming no drastic changes in technologic capacity and availability of electrical power (Hannan, 2008). • State public health agencies played an unusual role as facilitators of vaccine reallocation. Given some concerns about the Strate- gic National Stockpile scheme for allocating to states (e.g., not accounting for seasonal displacement) and some differences in states’ ability to purchase and stockpile antivirals, it is conceiv- able that a limited process of reallocation may become necessary in a pandemic. • A centralized CDC-based ordering system developed a few weeks after the emergency began, and there were some difficulties that having a system already in place would have prevented. This reflects the challenge of having needed information systems in place at the time of a pandemic. • Daily CDC partner calls were a helpful component of the response to the public health emergency. This may speak to the need for such close collaboration in a pandemic, although it cannot be overstated that a pandemic could place vastly greater burdens on public health partners’ time and ability to confer.

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 APPENDIX A SWINE FLU In early 1976, a respiratory disease outbreak at Fort Dix in New Jer- sey raised concern about an impending influenza pandemic like that of 1918. In a context of great uncertainty, government decision makers at the state and federal levels, including Army officials, notified state health departments and vaccine manufacturers about the information that was emerging. Aspects of the swine flu immunization campaign of 1976 may be particularly instructive because they involved taking action—mass vaccination—to prepare for what was thought to be an imminent pan- demic. There was uncertainty about whether what was being observed was indeed the beginning of a pandemic, and even the Advisory Commit- tee on Immunization Practices was unable to make a definitive statement. It is important to note that there were barriers to the implementation of the program. The most formidable was the insurance industry’s claim that it would be unable to provide liability coverage for the vaccination program. This led to passing of a tort claims bill (see Box A-1 for the con- temporary successor to that early law). BOX A-1 Liability Protection Provided by the Public Health Service Act (PHSA) The PHSA (Section 319F-3) immunizes manufacturers, distributors, program planners, “qualified persons,” and their employees for claims for loss concerning the administration or use of any “covered countermeasure” that is the subject of a declaration made by the Secretary of Health and Human Services. A covered countermeasure is a drug, device, or biological that is (1) subject to an emergency use authorization under the Federal Food, Drug and Cosmetic Act (Section 564), (2) used against an epidemic or pandemic and either approved or subject to an IND (investigational new drug), or (3) a security countermeasure as defined under the Project BioShield Act. “Claims” must be causally related to the administration or use by an individual of a covered countermeasure, including claims related to design, development, clinical testing, investigation, manufacture, labeling distri- bution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, or use of such countermeasure. This li- ability protection does not include liability protection for “willful misconduct” causing death or serious physical injury. “Section 319F-4 also allows the Secretary to, by declaration, establish an emergency fund in the Treasury which will be used to provide compensation for injuries directly caused by administration of a covered countermeasure.”

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 ANTIVIRALS FOR PANDEMIC INFLUENZA Many months passed between the initial isolation of swine flu virus from hundreds of samples and the implementation of the program, with no additional evidence of a pandemic emerging anywhere around the world. The vaccination program began 7.5 months after the first isolate of swine flu, and 45 million doses were administered in 10 weeks, a public health program on an unprecedented scale. The level of implementation of the program varied significantly, rang- ing from 10 to 80 percent of the population vaccinated across various jurisdictions. Approximately 85 percent of vaccine was administered in the public sector. There were communication problems, including rumors that required timely response with accurate information. Also, the commitment to vaccinate every person was not tempered by a similar commitment to re- evaluate the course of action on the basis of emerging information. In effect, there was no going back—a lesson, perhaps, about the perils of announcing a strategy that will require reconsideration due to change in circumstances (e.g., in the case of pandemic influenza, real-time data about the disease’s epidemiologic profile). One of the most important lessons to be learned from the swine flu immunization program may be that all interventions pose risk (Dowdle, 2008). Even in the face of a pandemic that could cause a high rate of deaths and severe illness, countermeasures, such as antivirals and vac- cines, are not risk free. It is essential to communicate to the public that antivirals have the potential for unknown risks, to provide clear risk– benefit statements, and to ascertain and address changes in the level of public perception of risk. ANTHRAX The public health response to the anthrax attacks in 2001 occurred in an environment of limited preparedness. Most public health agency preparedness for bioterrorism was in the early stages, so little existed in the way of ready-to-use dispensing mechanisms (staffing schemes, clinic set-up and flow, usable information systems, and so on). The experience of providing antibiotics to postal workers may pro- vide some potentially helpful information as jurisdictions prepare for pandemic influenza. For example, the labor unions questioned decisions to provide medication to some workers and not others, even if some of the latter were not exposed. There may be lessons to be learned about communication with stakeholders such as labor groups and about the imperative to fully protect workers who will be at risk. Furthermore, the distribution of antibiotics after anthrax contamination illustrates, in a lim- ited way, some issues that will arise in an influenza pandemic. The com- mittee learned about the emergence of a black market to sell medication

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 APPENDIX A obtained at dispensing sites. The dispensing sites provided some early experience with triage. There were lessons from communication activities, in the context of media attention, rumors, and mixed or unclear messages from government and community leaders. There was a shift in the type of medication and the required regimen (7 days of ciprofloxacin changed to 60 days of doxycycline), illustrating a mid-course adjustment that could be needed in a pandemic. Dispensing to postal workers occurred at two types of sites: hospital and postal processing center. Although the hospital setting facilitated refer- ral after triage (e.g., for acute condition), it was not necessarily convenient for affected individuals. The workplace (postal facility) was convenient for some and a familiar setting, but there were disadvantages because it was not a health care facility and so was not ideally suited to the functions of triage, education, and dispensing. The dispensing effort encountered groups with special needs, such as postal employees with hearing and visual impairments, as well as considerable proportions of workers need- ing mental health support, including the worried well (Bresnitz, 2008; Mahoney, 2008). Public health workers and their partners in the response to the anthrax attack also recognized adherence to treatment/prophylaxis regimens as a major challenge, requiring considerable education, as well as a high level of cultural competence. REFERENCES ASTHO (Association of State and Territorial Health Officials). 2006. The 00/00 influenza vaccine shortage: Implications for public health emergency preparedness. http://www.astho. org/pubs/InfluenzaVaccineShortage.pdf (accessed April 8, 2008). Bresnitz, E. 2008. Lessons learned from New Jersey’s post-exposure prophylaxis program following the anthrax attacks of 00: Applications to strategies for use of antivirals during an influenza pandemic. Presentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Wash- ington, DC. Dowdle, W. 2008. Lessons from . Presentation at Meeting Two of the Institute of Medi- cine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. FDA (Food and Drug Administration). 2008. Biological product shortages. http://www.fda. gov/cber/shortage/shortage.htm (accessed April 8, 2008). Hannan, C. 2008. 00–00 influenza vaccine shortage: Immunization program lessons learned. Presentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Mahoney, M. 2008. Presentation at Meeting Two of the Institute of Medicine Committee on Imple- mentation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC.

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