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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program 3 Ethics, Decision Making, and Communication This chapter discusses three interrelated issues: ethics, decision making, and communication. In a severe pandemic, questions about the allocation of scarce medical resources will be inevitable. Depending on communities’ levels of preparedness, responding to an influenza pandemic could be an overwhelming challenge for individuals, organizations, and government leaders. Preparing for the pandemic will require considering and communicating about contingencies in advance, developing an ethical compass to guide allocation decisions, and establishing mechanisms to ensure that antiviral use (like all other aspects of pandemic response) is rapidly adaptable to changing circumstances and new information. ETHICS A severe influenza pandemic poses different and far more challenging ethical dilemmas than a mild or moderate one. Chief among them is what proportions of the antiviral stockpile to commit to treatment and to prophylaxis and which groups to prioritize to receive those resources when demand exceeds supply. If medications are scarce, what ethical principles and goals should inform their allocation? For health-related resources in scarce supply, prior agreement on the ethical principles and goals that will guide strategic decisions and ground communications with the public is essential for a collaborative, coordinated response. Judgments about the optimal allocation of scarce resources are value
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program judgments. Although they must be informed by science and best available evidence, they are not the responsibility of scientists or other experts alone. Ethically informed plans to allocate antivirals on grounds other than individual medical need or the principle of “first come, first served” require the considered judgment of persons with diverse experience and expertise, including the public. In this chapter, the committee indicates ethical commitments, principles, and goals to be considered in developing an ethical framework to guide decisions concerning the allocation and dispensing of antivirals in a severe pandemic. Ethical frameworks have been offered from several sources, including the World Health Organization (WHO), the Department of Health and Human Services, several countries, and some states. A review of state pandemic influenza plans found that although most state plans acknowledged the importance of ethical considerations, they included little explanation of steps to take to ensure ethical decision making (Thomas et al., 2007). There is reason for concern that ethics may be viewed as important but secondary to programmatic activities such as planning dispensing sites and conducting exercises, rather than as the foundation for sound decision making. The proposed federal guidance on antiviral use strategies includes four ethical principles: fairness (all equally eligible have equal access to antivirals), utility (minimize harms of the pandemic), reciprocity (minimize risks to those occupationally at risk to benefit society broadly), and flexibility (adaptability to emerging information). The federal guidance also acknowledges the importance of procedural ethics, transparency, public inclusiveness, and reasonableness (i.e., rational choices consistent with societal values, especially when science is lacking). The committee considers this a good start on an ethical framework for resource allocation in a severe pandemic, and provides some distinctions, principles, and goals to consider, and a recommendation to build on this foundation. Many of the ethical frameworks that have been promulgated so far include ethical principles and goals, some include strategies and sample allocation plans based on detailed assumptions about the pandemic being planned for, and all of them include what might be described as “integrity factors” or ethical commitments based on respect for persons and the public (Kass, 2005, 2008). The committee finds it helpful to distinguish these three components of the ethical framework needed: (1) integrity factors/ commitments, (2) ethical principles, and (3) ethical goals. It is on the basis of the ethical framework that strategies for allocating scarce resources will be determined in an actual pandemic. The committee here offers a starting point for a broadly based effort to build a national ethical framework for use of scarce health resource, and specifically antiviral, allocation in a severe pandemic. What follows is an example of a set of ethical commit-
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program ments, principles, and goals, as well as (in Chapter 4) a list of clinical and non-clinical characteristics potentially relevant to prioritizing groups for antiviral treatment and prophylaxis (Kass, 2008; Vawter et al., 2008). Integrity Factors or Commitments A number of plans have included integrity commitments for government decision makers. These might also include citizen integrity factors such as individual responsibility (e.g., neighborliness) (New Zealand National Ethics Advisory Committee, 2007). Such integrity factors can be thought of as the glue of a truly communal response rather than divisive group or individual responses in a pandemic. The committee believes a clear statement of integrity commitments is needed to accompany the ethical principles and goals that will guide allocation decisions in the United States. Integrity factors to consider include commitments to trustworthiness, accountability, transparency, public engagement in determining ethically acceptable tradeoffs, and promoting a sense of shared purpose and individual responsibility through open processes of information, consultation, and communication. Ethical Principles Ethical principles, the second element in an ethical framework to guide resource allocation might include safeguarding population health, protecting public safety, preserving social order, promoting fairness on the basis of morally relevant characteristics (substantive fairness), and following fair procedures (procedural fairness). Ethical Goals The third element of an ethical framework consists of ethical goals. The goals associated with the principles above might include (1) protect population health by minimizing mortality and morbidity; (2) protect public safety by containing disruption to health, public safety, and other critical infrastructures; (3) preserve social order by informing, involving, and practicing open communication with the public (to promote understanding and cooperation); and (4) promote fairness by protecting groups taking risks (i.e., high exposure to influenza) for the sake of others and the population as a whole (reciprocity), by giving special attention to groups with excessive mortality risks, or by removing access barriers to care, and following procedures for equitable access to a resource when supply is insufficient for all who are eligible. It is important to understand how an ethical framework is to be
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program used in actual decision making. As with any ethical dilemma, allocation and prioritization decisions will require analyzing and determining the optimal way of giving balanced attention to all of the agreed-upon ethical principles and their associated goals simultaneously, not choosing among them and setting the others aside. Because information emerging in a pandemic is critical to making determinations of strategy, strategies and prioritizations can only be hypothetically chosen in advance. That is, based on detailed assumptions about how a severe, 1918-type pandemic would manifest itself today, resource allocation prioritization groups and strategies could be delineated in advance. There is the risk, however, that the public and priority groups would interpret such advance prioritization as more than the sample plan that it is, in need of adjustment to the characteristics of the real pandemic as it unfolds. For this reason, the committee does not suggest the composition of specific priority groups and only recommends a first level of prioritization (see Chapter 4 for the recommendation and additional discussion). A broadly based effort is needed to construct an ethical framework useful to a wide range of decision makers, beginning with the consideration of the candidate integrity factors, principles, and goals indicated in this report. All resource allocation decisions involve the balancing of a number of ethically compelling objectives (e.g., population health and fairness). A broadly agreed-upon framework is needed to provide a critical grounding for decision making, justification, and communication. The proactive development of an ethical framework to guide allocation can support consistent decisions across sectors and serve as a rationale and basis of communication across the United States. Such principles and goals will provide a needed basis for flexibility in response to local circumstances and accountability in assessing and adjusting scarce resource allocation strategies as the epidemiological characteristics of the pandemic become known. Such characteristics include attack rate, case fatality rates, high-risk groups, susceptibility to antivirals of a certain dose and duration for treatment and prophylaxis, resistance, and drug safety. The issue of resource allocation is understandably troubling to most people given the need to prioritize population rather than perceived individual interests. It is important for all levels of government to undertake efforts to engage and communicate with a diverse public about these sensitive issues and provide the public with a role in the decision-making process. Many jurisdictions, including the federal government, have worked to begin and sustain some major structured efforts of public engagement.. In 2006, a process of public deliberation sponsored by the Association of State and Territorial Health Officials and the Keystone Center, the Public Engagement Project on Community Control Measures for Pandemic
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program Influenza, gathered the input of organized stakeholders from various sectors and citizens-at-large (from four different areas of the United States) on five community control measures. The process led to the development of 13 priority recommendations, 1 of which related specifically to ethical decision making: Develop clear and practically useful guidance for making ethical decisions around the use of scarce resources and other difficult choices in a severe pandemic. Stakeholders shared concerns about decision making in regard to the distribution of scarce resources such as antivirals and “suggested creating ethical decision making guidance through a detailed process that begins with the federal funding of community-level conversations and deliberations on these topics. A work group would take the findings of the conversations and develop ethical guidelines to determine how scarce community resources would be dispensed” (The Keystone Center, 2007). The committee is optimistic that these kinds of efforts will help to create a sense of shared purpose around an emerging plan and later the implementation of antiviral distribution and dispensing.. Recommendation 3-1: The committee recommends that the federal government in collaboration with state, tribal, and local governments support the development of a national ethical framework to guide the allocation of antivirals (and other scarce health resources) during a severe influenza pandemic. Developing the framework should incorporate processes to obtain input from the public and a wide array of stakeholders. MAKING DECISIONS, CHANGING COURSE As noted earlier in this report, preparing for an influenza pandemic requires facing uncertainty, for example, about the timing of a pandemic, its point of origin, the speed of spread, its level of virulence, its epidemiologic profile and extent of resistance, and the causative strain of influenza. In the course of responding to the pandemic, more information will become available that may require changing aspects of plans that were made with unknowns in mind, and changes will need to be made rapidly, with input from relevant experts and communication to the public. The committee asserts that an entity and mechanism will be needed to support making national-level decisions in the course of implementing pandemic response, including the use of antivirals. There are several relevant federal advisory committees, including the Advisory Committee on Immunization Practices (ACIP); two committees that advise the Food and Drug Administration (FDA) on antiviral drug issues and drug safety issues, respectively; the National Vaccine Advisory Committee (NVAC);
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program and others. However, none is ideally suited, and indeed none has been constituted, to advise the government and its partners in responding to an influenza pandemic. ACIP is a federal advisory committee that advises the federal government on all dimensions of its immunization policies. Its advice is widely regarded as the definitive expert voice on immunization issues. During the smallpox vaccination implementation program in 2003 and 2004, ACIP played an important role in making recommendations regarding the risk–benefit profile of the vaccine, and provided other guidance in the course of the program, most notably at crucial points in its implementation, such as when serious adverse events were identified. ACIP also defined priority groups during the 2004–2005 seasonal influenza vaccine shortage. FDA advisory committees such as those on antiviral drugs and on drug safety and risk management are charged with considering a wider range of drugs from a regulatory perspective, and NVAC has the role of advising the National Vaccine Program Office on policy issues related to vaccine safety and effectiveness. There is no advisory body similar to ACIP constituted to advise the federal government and the medical and public health communities on the use of antivirals and other dimensions of a public health response during an influenza pandemic. The Infectious Disease Society of America also has called for such an entity to be established (IDSA and Poretz, 2007a). A pre-formed and on-call expert advisory body to the government is needed to address issues that arise in the course of implementation. This body could be constituted as a federal advisory committee, with meetings open to the public and to public comment, and with the charge to make recommendations to the Department of Health and Human Services and its partners at all levels of government. Recommendation 3-2: The committee recommends that as soon as possible a federal advisory body be formed to advise the federal government and its partners on the planning and implementation of public health and medical responses to an influenza pandemic, including antiviral use. Options for establishing an advisory body include creating a subcommittee under the National Biodefense Science Board or creating a new federal advisory committee to the Department of Health and Human Services. Scope of Work of the Advisory Body The pandemic influenza advisory body could meet as frequently as is deemed necessary in a pandemic, but would have the mandate of convening in real-time to respond to pressing questions within 24 hours. In
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program addition to the scientific expertise of members and emerging pandemic data and information, the work of the group also would be informed by the national ethical framework described earlier in this chapter. The role of the advisory body would include reviewing a variety of information and data and making recommendations about the following: Determinations regarding priority groups for treatment, for outbreak prophylaxis of groups with occupational exposure, and for post-exposure prophylaxis of groups with occupational exposure and household contacts of cases (on the basis of pre-identified parameters vetted and expanded in public dialogue about priorities) and changes in those priorities on the basis of new information The nature of and systems to capture antiviral adverse events, and implications of drug safety issues for the program course of action Surveillance of antiviral resistance in the pandemic strain of influenza and implications for antiviral use New, unapproved antiviral products or use of drugs in combination for treatment or prophylaxis Standard protocols (including algorithms for diagnosis) Mobilization of private-sector stockpiles Professional licensure issues Triggers for midstream changes in algorithms and guidelines Meetings of the advisory body also would serve as a forum for the public discussion of the issues identified above and others. The advisory body would take a comprehensive, transdisciplinary approach that cuts across all dimensions of antiviral use (in the context of pandemic response in its entirety). Among many difficult considerations, the group would likely need to assess changing legal norms (e.g., prescribing and dispensing authority) in declared states of emergency arising during pandemic influenza. Although many emergency legal issues may be addressed in advance, legal and other actors would be working in real-time to assess potential legal barriers and implement solutions conducive to protecting the public’s health during the emergency. These efforts, comprehensively referred to as “legal triage” (Hodge, 2006b) present the potential for divergent legal standards across all levels of government during the pandemic influenza emergency, which may affect the role and guidance of the advisory body. Legal triage describes “the efforts of legal actors and others to construct a favorable legal environment during emergencies through a prioritization of issues and solutions that facilitate legitimate public health responses” (Hodge, 2007).
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program Composition of the Advisory Body Membership in the advisory body would be broadly constituted through a nomination process involving posting in the Federal Register. The advisory body would include relevant scientific expertise in disciplines including, but not limited to, virology, immunology, medicine, and epidemiology. Supplementary expertise in ethics and law may be needed at some points. Mechanisms for obtaining additional expertise would be available to the group. In order to use expertise and established lines of communication, this advisory body would ideally include members with appropriate expertise from ACIP, NVAC, the FDA Vaccine Research and Biologics Advisory Committee, and the National Biodefense Science Board (NBSB).1 Additional members may be needed, including ex officio senior representatives from CDC, FDA, the National Vaccine Program Office, and the National Institutes of Health, as well as other relevant departments (such as the Departments of Homeland Security, Defense, and Veterans’ Affairs). COMMUNICATION Although the health care and public health communities have been engaging in dialogue and pandemic planning for several years, preparing the public sometimes has been an afterthought (Lanard and Sandman, 2005). A well-prepared public—in all its diversity—is crucial to support the efficient and effective use of antivirals. On the pages that follow, the committee offers some overarching principles for communication about antivirals, then a communication topic relevant to providers, and finally, four areas for public communication: antiviral risk and benefit, urgency of treatment, supply and priorities for antiviral use, and the need to implement a program of antiviral use in a manner that is flexible and responsive to emerging information. Planning the communication activities needed to support an antiviral drug program will first require initiating a dialogue with the public about antiviral medications and key issues in determining how to distribute a limited supply to achieve results that promote the greatest public good while minimizing the likelihood that individuals will be treated unjustly. 1 “The NBSB was created under the authority of the Pandemic and All-Hazards Preparedness Act, signed into law on December 19, 2006 … to provide expert advice and guidance to the Secretary of the U.S. Department of Health and Human Services (HHS) on scientific, technical, and other matters of special interest to HHS regarding activities to prevent, prepare for, and respond to adverse health effects of public health emergencies…” (Source: http://www.hhs.gov/aspr/omsph/nbsb).
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program Communication during pandemic influenza will be as important to outbreak control as are other public health tools. To ensure that plans for antiviral dispensing, as directed by national guidance and shaped by state and local capabilities and needs are effective, communication needs to be timely, accurate, and conducted in a linguistically and culturally appropriate manner. Attention to the very low health literacy of many U.S. adults also should inform plans for obtaining informed consent if needed (for example, if non-approved medications are used), medication distribution and dispensing, compliance with prescription, early detection and reporting of influenza symptoms, safety reporting, and so on. Timely communication implies (1) advance preparation of the public with information that is relevant to them before a pandemic begins, and (2) advance preparation of just-in-time messages and channels for delivery in a pandemic, identification of key spokespersons, and plans for ensuring consistent communication that is based on the best available information, does not overstate what is known, or does not hide or minimize what is unknown (Janssen et al., 2006). The committee finds it important to highlight several aspects of communication related to the antiviral distribution and dispensing component of pandemic influenza preparedness. These include the following: Communicating About the Goals of the Antiviral Use Program and Priority Groups to Receive Antivirals (for treatment, and, if applicable, prophylaxis) Whether or not the decision is made to identify priority groups in advance of a pandemic, the public needs to be informed about the ethical goals and other factors that will influence the decision-making process (ideally, this will be done in conjunction with a process of public engagement on the subject of prioritization for antiviral prophylaxis—see Recommendation 3-1). Antiviral drug stockpiles currently are not sufficient either to treat or to provide prophylaxis to the entire population of the United States, so dialogue is needed in advance to develop principles that will guide prioritization during the pandemic, once more is known about the disease’s epidemiologic profile. This area of communication is particularly important because the issue of scarcity raises the specter of panic. Some commentators on pandemic influenza planning express concern about the potential of widespread public panic to motivate a “run” on limited supplies and create a major problem for securing antiviral stockpiles (and maintaining order). A body of research in the social sciences indicates that the public reacts to disasters and emergencies in ways that are generally adaptive and constructive (Glass and Schoch-Spana, 2002; Auf der Heide,
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program 2004). Although the bulk of the findings are drawn from experience with major natural or man-made disasters, there is little data to support the hypothesis of a public out-of-control. Communication to Both Patients and Health Care Professionals About the Importance of Early Prophylaxis Public and patient education is needed on the subject of taking antiviral drugs for treatment or prophylaxis in a way that supports peak effectiveness (e.g., taking antivirals during the 48-hour window after onset of symptoms for optimal effectiveness, compliance with prescribed instructions). Such messages could perhaps be communicated in conjunction with messages encouraging isolation to limit transmission. Communication About Drug Risks and Benefits; Dispensing Site Instructions It is well understood that antivirals may have considerable benefits in an influenza pandemic, but they are pharmaceutical products, and like all such products, they present risks. Also, it is important to understand that the risk–benefit profile of antivirals may change during the pandemic, if serious and unexpected adverse events emerge or if resistance develops rapidly, thus modifying the drug’s effectiveness. If the pandemic strain is not as susceptible to antivirals as the seasonal strain(s), this would have implications for preparedness, and the risks posed by the drugs may outweigh the potential, but diminished, benefit. Assuming that antivirals are reasonably effective against the pandemic strain, compliance with the regimen of treatment and prophylaxis will probably be important in helping to slow the development of resistance. Dispensing sites will need communication materials on this subject that are clear, concise, and culturally competent. Experience with some past mass distribution events indicates that patients receiving medication at a dispensing site will not necessarily retain the instructions conveyed to them in writing and verbally, and they may think of other questions after leaving the site of dispensing (Mahoney, 2008). Additional means for communicating this information may be useful to explore, including call centers for the general public (for example, the state of New York is planning a provider helpline) and perhaps some of the range of communication technologies that currently connect a large proportion of the population, such as text messaging. Experience from previous outbreaks and influenza pandemics has shown that there is a potential for a high level of mistrust of governmental agencies and policies, as well as pharmaceutical manufacturers,
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program in response to this type of public health crisis. There also has been some degree of misinformation disseminated throughout the population via the mass media and rumor at these times. All of these factors can have a considerable effect on the public’s willingness to use antivirals and to use them effectively. In the event of a pandemic influenza outbreak, several strategies may help to overcome these barriers to an effective response. The involvement of trusted community leaders and agencies in communicating and educating the public about the dispersal of antivirals, along with pandemic influenza public health services that are delivered by culturally and linguistically competent providers, should help to bring about greater public compliance and improved efficacy in the distribution and appropriate usage of antivirals. Flexibility for Strategy Adjustment Policy decisions and public communication will be closely linked in a pandemic and will ideally be thought of jointly in the planning process as well. During the pandemic, the public will need to be informed about emerging information on the course of the pandemic, data that is being collected, and decisions being considered and made. For example, epidemiologic information may emerge that indicates that a different age segment or occupational group is at higher risk than originally understood, and that could lead to changing the priority groups to receive antivirals. Information could emerge about drug effectiveness or resistance that demonstrates the need to increase the dose and/or duration of antiviral treatment or prophylaxis. This could have a dramatic effect on antiviral supplies, and the rationale for the change and likely outcomes with and without the change will need to be communicated. Timeliness of communication by public health authorities will be of the essence, especially given the vast array of information sources that likely will be available to comment on various aspects of the pandemic—this may be one of the more striking differences between the social context of the 1918 pandemic and the contemporary context. The federal advisory body recommended above would play a central role in providing the best scientific guidance to address all dimensions of the pandemic response, including the use of antiviral drugs to contain and mitigate the pandemic. Other Public Communication Issues Communication About Where and How Antivirals Will Be Distributed In the event that some level of household post-exposure prophylaxis is needed, many or most jurisdictions intend to use their Strategic
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program National Stockpile (SNS) points of dispensing as the sites for giving out prophylaxis. Whether these or alternate sites or mechanisms will be used, targeted populations will need clear information about where to present and the process used to dispense, including screening for contraindications and dosage, and informed consent (if applicable). Additional consideration may be needed for messages about infection control at dispensing sites. Removing Barriers to Access Through Communication In planning the communication channels and messages related to antiviral dispensing, public health authorities and their partners should consider the needs of linguistically and culturally diverse communities and engage them in advance to identify the best ways to communicate. It is important to consider the broad spectrum of cultural variation within the United States and the impact that differing beliefs and values will have on the behaviors of the public during a modern day influenza pandemic. The overall linguistic and cultural diversity of the nation, coupled with documented gaps in overall health literacy and knowledge of public response from previous influenza pandemics, suggest that these factors should be considered when designing optimal delivery systems for antiviral distribution and conveying relevant information and education. Noting that the most important asset in any large-scale public health emergency is the public, the committee recommends the following: Recommendation 3-3: The committee recommends that state, tribal, and local public health officials preparing for an influenza pandemic develop partnerships with (1) the media, including ethnic media; (2) leaders of local faith communities; (3) community-based clinics; and (4) other trusted organizations and community leaders to convey vital public health information clearly, simply, and in a manner that respects and reflects cultural and linguistic differences. Communication with Health Care Providers In the response to a pandemic, health care providers will need ongoing support from public health authorities and from the Centers for Disease Control and Prevention (CDC). CDC-provider communication was especially poor during the response to the 2001 anthrax attack (see Appendix A). The 2004–2005 influenza vaccine shortage experience presents a good example of optimal communication between CDC and some of its partners. States were involved in daily calls with CDC to discuss their strategies and share information. In a pandemic, health care providers would
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Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program benefit from daily web-based (including delivery to hand-held devices) numeric and other information about the antiviral dispensing effort. Closing Observations In addition to logistic and scientific considerations such as establishing and testing dispensing sites and conducting surveillance of antiviral resistance, planning antiviral dispensing for pandemic influenza requires the following: Obtain public input, within a framework of agreed-on ethical principles and goals, on what is to be done Create an entity with relevant scientific expertise that can be trusted to give good and timely advice to government and its partners in implementing antiviral dispensing (and other aspects of pandemic response) Communicate to and with the public about how their input was included, what will inform mid-course corrections in the implementation of pandemic response, and what the public can and ought to know and do with respect to antivirals
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