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Introduction1

When—not if—the next influenza pandemic occurs, robust planning will be essential to ensure a successful response in the face of a health care system overwhelmed by thousands or hundreds of thousands of sick people, and those worried they may be sick. Influenza pandemics, such as the 2009 H1N1 pandemic that swept the globe, illustrate the need to plan ahead. One of the challenges public health officials may face is the need to distribute antiviral medications that can decrease the severity and duration of disease to large numbers of people. Distribution and dispensing will need to occur within the potentially limited time frame in which the medication is effective, and persist over a period of time to treat multiple waves of a pandemic.

In response to a request from the Centers for Disease Control and Prevention (CDC), the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events (Preparedness Forum) designed and convened a series of workshops (“community conversations”) that explored the public’s perception of potential alternative strategies for facilitating access to antiviral medications and treatment advice during an influenza pandemic. Based on its statement of task (Box 1) the workshop planning committee convened members of the general public in three locations—Fort Benton, Montana (MT), Chattanooga,

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1The workshops were organized by an independent planning committee. The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Forum, the IOM, or the National Research Council, and they should not be construed as reflecting any group consensus.



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Introduction1 When—not if—the next influenza pandemic occurs, robust planning will be essential to ensure a successful response in the face of a health care system overwhelmed by thousands or hundreds of thousands of sick people, and those worried they may be sick. Influenza pandemics, such as the 2009 H1N1 pandemic that swept the globe, illustrate the need to plan ahead. One of the challenges public health officials may face is the need to distribute antiviral medications that can decrease the severity and duration of disease to large numbers of people. Distribution and dispens- ing will need to occur within the potentially limited time frame in which the medication is effective, and persist over a period of time to treat mul- tiple waves of a pandemic. In response to a request from the Centers for Disease Control and Prevention (CDC), the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events (Preparedness Forum) designed and convened a series of workshops (“community con- versations”) that explored the public’s perception of potential alternative strategies for facilitating access to antiviral medications and treatment advice during an influenza pandemic. Based on its statement of task (Box 1) the workshop planning committee convened members of the general pub- lic in three locations—Fort Benton, Montana (MT), Chattanooga,                                                              1 The workshops were organized by an independent planning committee. The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Forum, the IOM, or the National Research Council, and they should not be construed as reflecting any group consensus.  1

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2 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION BOX 1 Statement of Task In response to a request from the Centers for Disease Control and Prevention, the Institute of Medicine’s Forum on Medical and Public Health Preparedness for Catastrophic Events will organize and convene a series of public engagement activities. These activities will explore the public's perception of the safety, feasibility, and acceptability of potential alternative strategies for distribution and dispensing of antiviral medi- cations to the public during an influenza pandemic. Participants will consider the need for, acceptability of, and advantages and disad- vantages of  receiving a prescription over the phone for antivirals from a medical professional other than a patient’s usual provider;  receiving antivirals or other medical countermeasures (MCMs) from a licensed pharmacist;  obtaining antivirals from a pharmacy during a severe pandemic; and  increased partnerships among state and local governments, the private sector, and other entities to dispense antivirals or other MCMs. A single individually authored summary of the public engagement activities will be prepared based on the information gathered and the discussions held. Tennessee (TN), and Los Angeles, California (CA)—during February and March 2012 to consider the acceptability of several alternative strat- egies of delivering antiviral medication to the public during a pandemic. These discussions will help to inform potential strategies still in the development stages at the CDC. The public was asked to consider, if an influenza pandemic were to strike, how the normal systems for prescribing and dispensing antiviral medications could be adjusted to ensure that the public has quick, safe, and equitable access to these potentially life- saving drugs and to information about the pandemic and treatment options.

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3 WORKSHOP SERIES SUMMARY Background Significant progress has been made in public health and medical pre- paredness since September 11, 2001. State and local public health au- thorities are currently responsible for the majority of medication distribution and dispensing activities within their jurisdictions during public health emergencies. During both a pandemic and in routine sea- sonal influenza, antiviral medications are used to lessen the duration and severity of a patient’s symptoms, not to be confused with a vaccine, which is administered to the well to prevent them from getting sick. Vac- cines take months to manufacture, in part because they must be specific to the influenza type. Antivirals, on the other hand, can work against many different strains of influenza. Because antivirals are more effective if taken within 48 hours of symptom presentation, many public health agencies have developed preparedness plans to facilitate the rapid dis- pensing of antiviral medications to large numbers of people during influ- enza pandemics.2 However, the feasibility and timeline of these plans remain significant concerns given projections that during a severe pan- demic, approximately 30 percent of the population could become ill over a 12- to 18-month period.3 In such circumstances, the normal channels through which antiviral medications are prescribed, dispensed, and dis- tributed could easily become overwhelmed. Indeed, the 2009 H1N1 in- fluenza pandemic brought to light several related challenges that need to be addressed during future preparedness planning initiatives. In response, the CDC is exploring alternate delivery systems for anti- viral medications during severe influenza pandemics. Potential prescrib- ing, dispensing, and distribution strategies include a variety of non- traditional mechanisms to ensure that people sick with flu receive antiviral medicines in a timely manner. These include  Nurse Triage Lines (NTLs): Phone hotlines that people with flu-like symptoms could call for advice, discuss whether an anti-                                                              2 For more information, see CDC, Antiviral agents for the treatment and chemo- prophylaxis of influenza: Recommendations of the advisory committee on immunization practices (ACIP) (Atlanta, GA: CDC, 2011). Available at http://www.cdc.gov/mmwr/ preview/mmwrhtml/rr6001a1.htm (accessed May 2, 2012). 3 Department of Health and Human Services (HHS), HHS pandemic influenza plan (Washington, DC: HHS, 2005). Available at http://www.flu.gov/planning-preparedness/ federal/hhspandemicinfluenzaplan.pdf (accessed April 18, 2012). Further clarification provided by personal communication with Lisa Koonin, senior advisor, Influenza Pandemic Unit, CDC, February 14, 2012.

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4 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION viral medication is indicated and, if so, possibly receive a pre- scription that the NTL would transmit to callers’ local pharma- cies for dispensing (if feasible). NTLs would be staffed by nurses who would be trained to follow a specific protocol and work under the direction of a physician. In addition to prescrib- ing antivirals, NTL nurses could provide guidance to the caller about whether to seek urgent care, as well as information about how to care for someone with flu. NTLs may be built onto an ex- isting regional hotline infrastructure (e.g., poison control centers) and may leverage other medical hotlines currently operated by health plans, hospitals, and health agencies.  Antiviral Pick-Up and Delivery by Community Contacts: A strategy to encourage family, friends, neighbors, and other com- munity contacts to pick up prescribed antiviral medications from pharmacies and deliver them to people with flu at home. Public health agencies would encourage people who have been pre- scribed antiviral drugs to ask others to pick up and deliver their prescriptions. They also would educate the public about the ben- efits of encouraging sick people to stay home to prevent the spread of the virus, and encourage their active support in helping friends and neighbors. More coordinated programs might be set up through local community organizations whose staff or volun- teers could provide this service.  Pharmacist Prescribing Under Collaborative Practice Agreements: A system through which a person sick with flu could visit certain pharmacists who would be authorized to pre- scribe and dispense antiviral medications according to approved protocols developed by influenza experts. Such pharmacists would work under formal “Collaborative Practice Agreements” with physicians who would provide supervision and consultation. The CDC also is exploring new strategies to communicate clear, ac- curate information about pandemic influenza and treatment to the public, including  Web-Based Tool: A web site launched during a pandemic for the purpose of helping people sick with flu-like symptoms and their caregivers to decide whether to seek medical care and to advise them when to seek treatment options, including antiviral medications.

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5 WORKSHOP SERIES SUMMARY  Text-Messaging Tool: An opt-in system through which people prescribed antiviral medications could receive text messages containing information about their flu treatment, potential side effects of antivirals, reminders to take their medicine, and other relevant advice. These strategies are not yet government policy and are still under ex- ploration. Determining the feasibility and acceptability for these alterna- tives is ongoing with public health officials and private-sector entities. Before moving ahead, however, the CDC recognized the importance of also exploring the public’s perception of the safety, feasibility, and ac- ceptability of these strategies. Therefore, it asked the IOM to design and convene community conversations in three locations across the country to engage the public on the five strategies outlined above. About This Summary This document is intended to summarize the discussions and key takeaway points at the three community conversations. Unique ideas pre- sented at the workshops are not attributed to individual participants, in keeping with the workshop design that intentionally excluded the record- ing of personally identifiable viewpoints in order to protect participant confidentiality and create an environment in which these topics could be discussed openly. Situations where several participants made similar points at all three community conversation locations are identified as “common themes.” Throughout the summary, themes identified at a spe- cific community conversation are followed by the appropriate two-letter state abbreviation of that location in parentheses. It is important to note that there is inherent variation in the specific discussions that took place at each community conversation, which is attributable to the individuali- ty and diversity of each participant group. Therefore, the absence of dis- cussion on any one specific idea in a particular location does not suggest that those participants were in favor or against that idea. Any opinions, conclusions, or recommendations discussed in this workshop summary are solely those of the individual participants and should not be con- strued as reflecting consensus or endorsement by the workshop, the Pre- paredness Forum, or the IOM.

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6 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION DESCRIPTION OF THE “COMMUNITY CONVERSATIONS” The purpose of the “community conversations” was to obtain input from a diverse cross-section of the public about the acceptability of pos- sible strategies to facilitate access to antiviral medications during a flu pandemic. The community conversations were designed to  inform participants about antiviral medications, the challenges of getting them to the public during a flu pandemic, and current planning efforts to address these challenges;  gather input about the acceptability and feasibility of possible al- ternative strategies for the quick, safe, and fair prescribing and dispensing of antivirals in a pandemic, and about strategies for informing the public about pandemic influenza and treatment; and  encourage broad participation that includes members of typically vulnerable and hard-to-reach populations. The goal of the community conversations was not to promote or reach consensus or agreement. Similarly, the themes generated by partic- ipants’ discussion during these three workshops cannot be generalized to other populations or communities. Rather, their purpose was to elicit a variety of opinions, concerns, and the participants’ own ideas for the CDC to consider in its subsequent policy deliberations. The use of this type of public engagement is ultimately advisory. It can help policy mak- ers understand an array of priorities and values that might be important to individuals and to the public at large, and on what issues people differ and why. It also can alert policy makers to areas of potential misunder- standing or distrust, where greater awareness will have to be fostered to promote public acceptance and cooperation when plans are implemented in an actual public health crisis. Planning and Participant Recruitment The IOM was charged with organizing community conversations in three geographically and demographically diverse locations. These ses- sions were to convene a total of 200 individuals representing a diverse cross-section of the local populations, including people who might need additional assistance in a crisis (e.g., elders, people with disabilities, oth-

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7 WORKSHOP SERIES SUMMARY ers who routinely face barriers to accessing care). However, these activi- ties are not meant to be a statistical representation of the locations or of the nation. Therefore, any themes identified reflect only the participants and not necessarily the larger community. The IOM partnered with local public health and community organi- zations in each location. The role of the local partners was to spearhead community outreach and recruitment of participants and key personnel and to assist in the planning and execution of the sessions. The three ses- sions were scheduled as follows: 1. Fort Benton, MT: Rural frontier; February 9, 2012; local part- ners: Montana State University, Choteau County Extension, and Chouteau County Public Health. 2. Chattanooga, TN: Midsize urban; February 16, 2012; local part- ner: Chattanooga-Hamilton County Health Department. 3. Los Angeles, CA: Large metropolitan; March 2, 2012; local partner: Healthy African American Families II, Department of Public Health–Los Angeles County. The target attendance were 50 participants in Fort Benton and in Chattanooga and 100 in Los Angeles. The Fort Benton and Los Angeles sessions were oversubscribed (75 and 108 respectively), while the Chat- tanooga session included 49 participants, bringing the total number of participants to 232. Local partners were provided with demographic re- cruitment targets for age, sex, race/ethnicity, and education level based on U.S. Census data for their counties. While there was no formal requirement to meet those targets, only Los Angeles did not.4 The Los Angeles session had approximately 15 monolingual Spanish-speaking participants.5 Local partners also were provided with standard communications tools to use in their participant recruitment efforts. The program name used on materials targeted to the general public was In a Flu Pandemic: Getting Life-Saving Medicines to the Public. The IOM and the local                                                              4 The Los Angeles session was intended to draw participants from throughout Los Angeles County. Most of the actual participants, however, were from South Los Angeles and reflected the demographics of that predominantly African American and Hispanic/Latino community.  5 In Los Angeles, simultaneous interpretation was conducted for the large-group activities. At two tables, small-group discussions were facilitated in Spanish and reported out in English by bilingual table facilitators. Notes were recorded in English by bilingual note takers. Participants received Spanish-language translations of all printed materials, as well as printed copies of the translated Audience Response System and Introductory Slides, described below. 

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8 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION partner organization were identified on materials as program sponsors. An example of the key recruitment messages used can be found in the appendix. Participants were offered $50 stipends as compensation for their time and to help cover any out-of-pocket costs of attending the session. Sti- pends also likely facilitated the recruitment process by providing a small incentive to attend.6 Agenda and Tools The IOM planning committee developed a set of program materials to run 4-hour sessions at all three venues.7 These materials were designed to provide participants with the background and tools they would need to engage in informed discussions about alternative strategies for facilitat- ing access to antivirals in a flu pandemic. The main elements of the agenda can be found in Box 2. BOX 2 Major Structural Elements of Each Public Engagement Workshop Introductory Exercise: Small-group table discussions to break the ice, establish ground rules, and introduce participants to the facilitated discussion and report- out method. All participants were invited to state briefly why they decided to at- tend the community conversation and to identify their greatest hope and greatest fear should a flu pandemic strike. Audience Response System (ARS) Presurvey: A series of questions about participant demographics and other relevant characteristics, followed by a series of opinion statements related to the proposed alternative strategies for delivering antivirals during a severe pandemic. Participants used electronic response de- vices (handheld keypads) to respond to questions and statements that were both projected as slides and read aloud to accommodate participants with low vision                                                              6 In Fort Benton, stipends were not mentioned in the recruitment process; participants first learned of the stipends in the confirmation materials they received after registration. In Los Angeles, stipends were offered during recruitment, but participants were informed at the start of the session that their receipt of the stipend did not require them to stay or participate in the entire session.   7 The agenda and tools are based on the IOM’s model and method for engaging the public on “crisis standards of care” guidelines for prioritizing the allocation of scarce medical resources in pandemics and other major disasters (Institute of Medicine, Crisis standards of care: A systems framework for catastrophic disaster response [Washington, DC: The National Academies Press, 2012]). 

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9 WORKSHOP SERIES SUMMARY or literacy. The main purpose of the presurvey opinion statements was to quickly immerse participants in the topic and to focus their attention on the issues that would be considered during the session. Expert Presentation: A slide presentation providing background on pandemic influenza, antiviral medications, anticipated challenges in delivery of antivirals during a pandemic, and proposed alternative strategies for discussion during the session. The information was targeted to general public audiences. The issues were framed as follows:  In a severe pandemic, people seeking antiviral drugs could meet many roadblocks: o Many people sick at the same time. o Crowded hospitals, medical offices, and clinics. o Long waits to see a health care provider for a prescription. o Sick, contagious people occupying waiting rooms and other public spaces. o People not sure where to turn for information.  In response, possible new strategies are now being developed: o To provide quick, safe, fair access to antiviral drugs (nurse triage lines, pick-up and delivery by community contacts, pharmacist pre- scribing). o To offer advice to sick people and the worried well (pandemic flu web site, text-messaging tool).  We want to hear your views on these potential strategies, and other ideas you might have. Small-Group Scenario Discussions: Two 30-minute scenario discussions, led by table facilitators, at the core of the agenda. Participants were asked to consid- er specific questions about the acceptability and feasibility of possible alternate strategies for delivering medications under two sets of circumstances, described in the scenarios as:  A severe flu pandemic that has led to long delays to see health care providers who can write prescriptions for antiviral medications.  A point in time during the pandemic when there are no longer enough antiviral medications for everyone in need. Report-Outs to the Large Group: Following each small-group discussion, brief presentations by table representatives of three key points that table members elected to share with the full group. Local Partner Presentation: Short presentations by local partners or their de- signees on public health preparedness planning and resources available to the local community, and an opportunity for participants to receive answers to ques- tions about local preparedness initiatives. Continued

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10 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION ARS Postsurvey: After the last group activity, a repeat of the same opinion statements to which participants responded in the presurvey, immediately follow- ed by display of the comparative responses from the pre- and postsurveys for participant reaction and discussion. Evaluation: A series of statements delivered by ARS to elicit participants’ opin- ions about their experiences and perceived value of the community conversa- tions, followed by written responses to several open-ended questions. Personnel Many individuals played key roles in orchestrating and leading the community conversations. Table facilitators and note takers were provid- ed with background and program materials in advance of the community conversations, including a “Guide for Table Facilitators and Note Tak- ers” and a briefing memorandum with additional subject-matter back- ground and suggested answers to anticipated participant questions about pandemics and antiviral medications. The day prior to their sessions, they attended 2-hour trainings where they received further introduction to the topic, agenda, and tools, and participated in a simulation of one of the discussion scenarios. Immediately following the community conversa- tion, they participated in a debriefing. Table facilitators and note takers were paid stipends to compensate them for their time preparing for and attending the community conversations. Process for Small-Group Discussions Throughout each community conversation, participants engaged in small-group discussions at their tables about the various questions and issues presented to them, and also reported out and engaged in further discussion with the large groups. Their comments were documented in several ways. For the small-group introductory and scenario discussions, trained note takers at each table recorded key points by writing them on highly structured templates designed for this purpose. For the report-outs on the two discussion scenarios, each table was asked to complete a form on which they wrote the three main points they planned to share with the full group. These forms were collected, and additional note takers recorded the ideas presented by the table representatives in their report-outs and during the ensuing large-group discussions. Finally, most participants completed short written evaluation forms at the end of the session.

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11 WORKSHOP SERIES SUMMARY In addition to engaging in small- and large-group discussions, partic- ipants responded to audience response system (ARS) questions about themselves (e.g., demographic and other personal characteristics such as health insurance status), pre- and postsurvey statements related to access- ing antiviral medications in a pandemic, and an evaluation of the com- munity conversation. During these ARS surveys, electronic viewpoints were collected automatically and anonymously by means of participants’ handheld response devices. To preserve participant confidentiality, note takers and the partici- pants themselves were instructed not to record participant names or any other potentially identifiable viewpoints on the note-taker templates or elsewhere. Because the ARS response devices were distributed randomly to participants, the electronic viewpoints cannot be connected to particu- lar individuals. The information recorded on the note-taker templates from the 27 ta- bles were robust in all but a few instances. Most of the notes were de- tailed, legible, unambiguous in meaning, and relevant to the topic. Note takers occasionally recorded direct quotes but, as instructed, they primar- ily summarized and synthesized participant ideas and themes. They ap- pear to have captured predominant themes similarly recorded by other attendees taking general notes during each session (e.g., planning com- mittee members and IOM staff in attendance, local partners’ staff). Notes from the report-out sessions were also of high quality. This summary makes general reference to the ARS pre- and postsurvey viewpoints where appropriate. The primary purpose of these surveys was not to collect data, but rather to engage participants, helping them to focus on the issues at hand. The viewpoints are not detailed in this summary to avoid any possibility that the results could be miscon- strued as generalizable to populations beyond the three participant groups. However, changes in the trends of participant responses between the pre- and post-ARS exercises may indicate the potentially positive effects of informing participants about as well as engaging them in the issues. SESSION SUMMARIES This section summarizes the characteristics of each community con- versation, and describes common themes among the three sites and with- in each session. Neither the session characteristics nor the identified

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30 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION Not only did participants discuss the content of the web site, but they were asked to discuss whether the sponsor of a pandemic flu web site would matter to them and, if so, whether a government or private sponsor would be preferable. Many participants at all three sessions indicated that the sponsor would be important, and that the sponsor—whoever it is— must be a reliable broker of accurate information. On the question of whether such a web site should be sponsored by a government or private entity, responses were mixed, with many participants expressing neutrali- ty on the issue. Individual participants who favored a government spon- sor cited the following reasons: (1) commercial web sites tend to be promotional and, thus, less trustworthy; (2) government has the requisite expertise and access to information; and (3) government has a duty to protect the public’s health, including the role of information dissemina- tor. Several participants who favored a private sponsor noted a general distrust of government. Finally, notwithstanding the possible barriers and other concerns cit- ed by some, many participants at all three sites thought that, if they had flu-like symptoms, they “would like to be able to go to a trusted web site for advice on whether to seek treatment.” Text-Messaging System The second information strategy consists of a text-messaging system that would issue a series of messages to people who already have been prescribed antivirals. This strategy was presented in general terms as a way for people to opt in to receive text messages from “the experts” that could help them manage their antiviral treatment. Participants were asked to consider “a system that would send text messages to cell phones of people who have been prescribed antiviral drugs—at their request—to remind them to take their drugs, to advise them of possible side effects, or to provide other information about their flu treatment.” Individual participants who favored this strategy listed the following advantages in favor of it:  Text messaging would be a convenient source of additional information.  Such a service would be particularly popular among younger people.  Cell coverage is stronger and more complete for texting than it is for calling.

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31 WORKSHOP SERIES SUMMARY  Text messages would provide a record of information to which recipients could refer back.  Reminders to take the antivirals were perceived by many as a good idea. However, other participants expressed some concerns, such as:  Text messaging is not accessible to all. o The elderly tend not to text. o Some people do not own cell phones.  Frequent text messages cause people to disregard them.  A high volume of text messages could overload the phone system.  Cell coverage is poor in certain locations and in bad weather (MT).  Text messaging would be unaffordable to some, unless the ser- vice is provided free of charge (CA). Several participants offered other suggestions for maximizing the value of phone-based tools. One example is the importance of ensuring that the sender of the text messages is a reliable, neutral source. Another suggestion is to offer e-mails as well. Other participant ideas included (1) weaving in positive, reinforcing messages to support sick people’s emo- tional well-being; (2) providing an option to “stop” receiving text mes- sages; and (3) offering text messaging as a free service. The positive response of many participants at each site to the concept of an opt-in text-messaging system is reinforced by the ARS survey re- sponses, in which many participants indicated they would like the option to receive text messages about the flu and the antiviral medications they were prescribed. When Antiviral Medications Are in Short Supply The second scenario added the complicating factor of scarcity: now, participants were told, not only are the normal channels for getting pre- scriptions for and acquiring antiviral medications congested, but there is not enough antiviral medication for everyone. Participants were asked to consider four questions related to scarcity:

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32 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION 1. If there is a shortage, do you agree with the policy to limit antivi- ral drugs to people at highest risk for serious problems or death?  Are there other preferred policies for allocating scarce antivirals? 2. Should all health care providers follow the same rules when de- ciding who should receive this limited supply of drugs?  If so, are there some circumstances when individual health care providers should be allowed to make decisions that go against the rules? 3. When there are not enough antivirals to go around, would you trust NTLs to get these drugs to the people who should receive them? 4. When there is a shortage of antiviral drugs, what are the most important values and goals? Policies for Allocating Scarce Antiviral Medications Participants discussed whether, if antiviral medications are in short supply, the policy should be to limit distribution to members of groups identified as at high risk for complications or death. Participants also were asked to consider whether they would prefer an alternative alloca- tion scheme such as “first come, first served” or a lottery. No additional information was presented to participants about how these different strat- egies could be implemented or about the trade-offs that each would entail. Many participants at all three sites strongly supported the concept of directing scarce resources to people in greatest need who would benefit the most. Most of the reservations about this approach were expressed as a desire to create exemptions or exceptions to the rule for certain groups or under certain circumstances rather than a wholesale rejection of the idea. Several themes of the discussion across the three locations included that:  Allocating scarce antivirals to people in high-risk groups: o Will save the most lives o Is equitable if applied consistently o Otherwise, people of means will have an unfair advantage in accessing treatment  Trust in judgment of medical experts about high-risk designa- tions is necessary and warranted

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33 WORKSHOP SERIES SUMMARY  Some groups—in addition to the high risk—should always re- ceive priority: o Ideas varied ideas about which groups should qualify for this priority status (e.g., children, pregnant women, medical re- sponders, elders)  Anyone who is truly sick should be eligible to receive antivirals (CA, TN) Some discussion in at least one location considered on other aspects of the issue of how to dispense antiviral medication in an atmosphere of scarcity, citing the idea that:  People in high-risk groups should only receive scarce antivirals if they are likely to benefit (CA, TN).  Determinations as to which populations are at high risk must be reliable (CA, MT).  Local authorities should have a say in determining antiviral allo- cation, after taking into account CDC or state guidelines (CA, MT).  Exceptions should be made for people with special medical con- ditions who are not within the identified high-risk groups (e.g., immunosuppressed, asthmatic) (CA).  Incarcerated and institutionalized populations should not be ex- cluded or disadvantaged by any allocation strategy (CA). Several small-group discussions at all three community conversa- tions recognized the merit of “first come, first served” and lotteries, but generally disfavored both of these allocation strategies. Lotteries were regarded by some as fair given their relative randomness and lower risk of discrimination against the powerless. But more participants saw lotter- ies as logistically difficult, potentially chaotic, and subject to gaming. Some also noted that, because randomizing distribution ignores potential risks and benefits, lotteries also are likely to waste scarce resources on people who do not need them. “First come, first served” was even less well regarded as an allocation strategy by many. Although some partici- pants asserted that “first come, first served” might be fair in the sense that it removes third parties from the decision-making process, many par- ticipants were concerned that it would put certain populations at an un- fair disadvantage while favoring those with the circumstances or means to access the system quickly and to their benefit.

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34 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION Despite the general disapproval of “first come, first served” and lot- teries, some participants suggested that these allocation approaches could be useful for distributing any remaining supply of medications once the high-risk groups have been treated or for allocating within a high-risk group if the supply of antivirals is so limited that it will not cover even that entire group. The ARS survey responses for each session indicated a trend of sup- port for allocating scarce antivirals to “people who need them the most,” consistent with the relative weight of individual participant views report- ed from the scenario discussions. Provider Uniformity or Flexibility When Prescribing Scarce Antiviral Medications The final question addressed by participants was whether all health care providers should follow the same rules when deciding who should receive scarce antiviral medications. Individual participants who agreed with this proposition also were asked to consider whether there are some circumstances under which individual health care providers should be allowed to make prescribing decisions that deviate from the rules. On the preliminary question, several strong themes emerged, including  Consistency in decision making is essential for reasons of equity and promoting trust in the system.  Provider adherence to guidelines is likely to result in more anti- viral medications going to people who need them the most.  Use of uniform prescribing guidelines is the most fair approach because the guidelines help prevent: o Discrimination o Favoritism by providers who have established patient relationships o Certain wealthy, powerful individuals from buying access  The CDC and other health agencies can be trusted to use their expertise to set appropriate guidelines. The question of whether it would ever be acceptable for providers to “go against the rules” elicited mixed reactions. Many participants assert- ed that allowing any flexibility would lead to too many exceptions and, in turn, unfair allocation decisions. Others believed that some flexibility in providers’ exercise of their professional judgment would be advanta-

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35 WORKSHOP SERIES SUMMARY geous. Those in favor of flexibility recommended instituting controls such as guidelines that define when such flexibility would be warranted. Such guidelines should also clarify that exceptions to the rules are rare and must be based on reliable information about a patient’s condition rather than bias for or against certain individuals or groups. Other com- mon suggestions were that providers should have the discretion to pre- scribe antivirals to people who are truly in need, or on the margins of a high-priority category (e.g., a 59-year-old if the cut-off were age 60 and above). Several participants conveyed unsolicited thoughts about enforce- ment of prescribing guidelines during times of scarcity. Suggestions in- cluded creating a hotline or other system through which providers and the general public could report noncompliance, and establishing and en- forcing sanctions against providers who break the rules. Individual Participants’ Ideas for Prescribing and Dispensing Antiviral Medications in a Flu Pandemic At various points throughout the community conversations, partici- pants were encouraged to contribute their own ideas about other strate- gies for getting antivirals to the public quickly, safely, and fairly. Individual participants offered numerous suggestions that fell roughly into three categories—dispensing, communications and outreach, and preparedness planning. Dispensing Common themes discussed by several participants at each location related to expanding human resource capacity by recruiting workers and community members who normally would not play roles in the delivery of antiviral medications; using a variety of community settings as alter- native distribution centers; and repurposing mobile resources to deliver antivirals to people in the community. Themes included  using schools, libraries, post offices, senior centers, and places of worship as dispensing centers to increase convenience and re- lieve pressure on pharmacies;  setting up drive-throughs at pharmacies to provide face-to-face contact with pharmacists while facilitating social distancing to prevent the spread of disease;

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36 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION  setting up points of dispensing in key locations; and  tapping into existing networks of community and government organizations to deliver antivirals to people who are sick at home. Several participants in Fort Benton indicated that they would trust veterinarians to prescribe antiviral medications in order to expand pre- scribing capacity. Two minor themes raised at the Los Angeles session were (1) the need to regulate the distribution of antivirals to pharmacies so that every local community receives its fair share; and (2) the creation of a system through which people could return unused antiviral medica- tions for distribution during times of shortages. Communications and Outreach Many participants at each location identified the importance of em- ploying a wide assortment of communications tools—traditional media (e.g., television, radio, direct mail, billboards), new media (e.g., Twitter, Facebook), and Public Alert Networks (e.g., Reverse 9-1-1)—to push information about the pandemic and antiviral treatments out to the pub- lic. The use of varied communications tools was considered by many to be the most effective at reaching diverse audiences. Other participants suggested deploying EMTs (emergency medical technicians) and other health care professionals to conduct information sessions in local neighborhood settings, and ensuring that communica- tions will be accessible to people who are deaf or hard of hearing or have impaired vision. An idea from the Los Angeles session was to recruit celebrities to star in public service announcements, while many partici- pants in Fort Benton recommended the promotion of word-of-mouth information-sharing strategies like phone trees. A Los Angeles partici- pant also suggested developing a community support network to check on senior citizens to make sure they know how and when to take the an- tiviral medications that have been prescribed for them. Preparedness Planning Numerous participants at each site frequently noted the general need for public education and awareness prior to the onset of a flu pandemic; individual participants in Chattanooga recommended engaging the public in preparedness drills. Several in Los Angeles suggested previewing and

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37 WORKSHOP SERIES SUMMARY getting buy-in from the community on any proposed dispensing plan through neighborhood councils. Another suggestion was to encourage prior credentialing and training of volunteers who could be deployed to respond to a pandemic. Additional Participant Comments At each of the community conversations, ideas emerged that either represented overarching themes for that session or were not directly within the scope of inquiry, but are relevant and worthy of acknowledg- ment nevertheless. In Fort Benton, some participants raised the question of why the Food and Drug Administration or other federal agency could not simply approve the over-the-counter sale of antiviral medications during a flu pandemic as a way of resolving the prescribing bottleneck, considering the drugs to be relatively safe. Consistent with repeatedly voiced con- cerns that rural areas are at a disadvantage to the “big cities” when it comes to prompt allocation of critical resources like antivirals, several participants also questioned why rural public health agencies could not simply stockpile locally. But perhaps the most frequently repeated theme at this session was the high level of trust and cooperation that permeates rural communities, and the sense that Fort Benton would be among the best places to be during a major pandemic. This theme of trust was also evident in Chattanooga, where the em- phasis was on participants’ trust in the knowledge and character of health care professionals “to do the right thing” when prescribing and dispens- ing antivirals during a pandemic. However, some Chattanooga partici- pants did voice worries about the sufficiency of medical stockpiles and concerns about access to treatment by the uninsured. Many of the Los Angeles participants’ references to “trust” were cast differently than at the other two sessions. A general distrust was fre- quently expressed at this venue, attributed to minority communities’ in- teractions with the health care system. Beyond specific concerns about how and where critical resources would flow during a crisis, several participants—citing the neglect of patient consent in the 1932 Tuskegee syphilis study—shared their belief that minority groups would be used as “human guinea pigs” to test antivirals and vaccines, but would be the last to receive the benefit of these treatments. A few Los Angeles participants also voiced worries about the safety and components of antiviral medica- tions themselves (the risk of “contamination”), and a desire both for al-

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38 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION ternative holistic remedies and for safeguards to prevent pharmaceutical companies from rushing to market dangerous drugs. A comment that arose in all three locations was that preparedness planning for pandemic influenza—and other public health emergencies requiring the large availability of medications—should be sufficiently robust that scarcity should never be an issue. Each session included one or more participants who were adamant about this point, some of whom took the time to record comments on index cards or their written evalua- tion forms. Several participants in Fort Benton and Chattanooga favored a strategy of allowing or encouraging the stockpiling of antivirals at home. A few examples of written comments from the Chattanooga ses- sion include  “Most important—we should not run out!!! Make sure there are enough meds for everyone.”  “If gov’t handed out a bottle per family right now, most of these scenarios would never happen.”  “If you distribute [the stockpile] now, there’s not a possibility of rushing or overcrowding, and no chance of contamination during delivery.” Participant Evaluations Finally, participants were asked to share their perceptions about the quality and value of the public engagement process through a series of ARS statements and a brief written form that provided the chance for them to identify the most valuable parts of the session, whether anything was missing, and add any other comments they might have. Participant ARS responses for all three community conversations reflected several common themes:  The information presented was trustworthy and helped them un- derstand the challenges of getting antivirals to the public in a pandemic.  The scenario discussions were productive and allowed them to express their views.  Hearing other participants’ opinions was useful.  By the time they took the postsurvey, they had a better under- standing of the issues.

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39 WORKSHOP SERIES SUMMARY  They would recommend that family and friends participate in a similar session if offered the chance. On their written evaluations, many participants in all three work- shops reported that they felt well informed about the issues which they were asked to discuss, and that the agenda and materials gave them ade- quate opportunity to have meaningful discussion and express their ideas. DISCUSSION Few significant regional differences emerged across the community conversations. Individual participant commentary from all three sessions indicated widespread support for the overarching concept that public health authorities should develop alternative strategies to help people gain access to antiviral medications during an influenza pandemic. As noted above, many participants also expressed broad acceptance of all of the specific prescribing and dispensing strategies presented, as well as for the web site and text-messaging tools aimed at enhancing public ac- cess to information and advice about pandemic flu and treatment with antiviral medications. Many participants also acknowledged the advantage of a “layered” approach to facilitating access to antivirals (i.e., the need to employ mul- tiple strategies to reach different groups and respond to different circum- stances). Qualitative information from several small-group discussions underlined the understanding that no single strategy could satisfy all needs at once; even when some participants voiced criticism of individu- al strategies on the basis of identified limitations, they still regarded them as generally acceptable. Several participants across the three sites did express reservations about the application of certain proposed strategies in the context of children (i.e., perceived safety issues), and when antivi- rals are in short supply (i.e., concerns about dishonesty and unpreventa- ble “gaming” of the system). Alternative prescribing and delivery strategies will have to account for these concerns in order to receive the public’s trust and acceptance when implemented in a pandemic. Finally, public trust and acceptance also will depend on continued education to

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40 FACILITATING ACCESS TO ANTIVIRAL MEDICATIONS AND INFORMATION build public awareness and understanding of these or other alternative strategies.11 FINAL REMARKS These community conversations on alternative strategies for facilitat- ing access to antiviral medications during an influenza pandemic repre- sent a novel initiative by the IOM to engage the public in public health preparedness planning at the national level. As intended, the three ses- sions convened members of diverse regions and populations for vigorous discussion of the acceptability of alternative delivery and informational strategies for antivirals presently under development at the CDC. Although the outputs generated by these public engagements do not rep- resent a consensus and are not generalizable to wider populations, they do describe a variety of attitudes, concerns, and potential areas of misun- derstanding that the CDC could expect to encounter in its future planning activities or when implementing any of these strategies during a pandem- ic. Similarly, they include potentially useful suggestions for improving or building on the current proposed strategies. Finally, the purpose of these community conversations was not to test the general value of public engagement in the development of public health strategies. However, the depth, breadth, and quality of the infor- mation yielded by the discussions, the apparent increase in participant understanding and acceptance of the proposed strategies, and the positive responses reflected in evaluations all suggest that these types of forums offer reciprocal benefits to participants and policy makers and have a great potential to positively impact the development of public health policy.                                                              11 One observation, common throughout the community conversations, was the tendency of many participants to refer to antiviral medications and vaccines interchangeably. Whether misunderstandings relate to differences between medications and vaccines or differences among antivirals (i.e., to treat people with influenza or HIV), policy makers should not assume that everyone is knowledgeable about the distinctions.