Managing Threats and Ensuring Healthy Communities: Health of the Public

Public health is fundamental to every individual’s health. An Institute of Medicine (IOM) committee in 1988 described the mission of public health as fulfilling society’s interest in assuring conditions in which people can be healthy. Yet each individual’s health and well-being are shaped by the interactions of genetic endowment, environmental exposures, lifestyle and food choices, social conditions, income, and medical care. Collectively, these factors shape health at the population level—the domain of public health.

As a reflection of its broad spectrum, public health is perhaps the most diverse area the IOM investigates.

As a reflection of its broad spectrum, public health is perhaps the most diverse area the IOM investigates. The studies deal with important—and sometimes contentious—challenges that affect people from every walk of life, in every part of the country.

Preventing disease, early detection, and effective treatment

Since its founding, the IOM has consistently stressed the value of prevention of disease, a core tenet of public health. In studies ranging from core principles and needs in the field to specific issues such as health disparities, vaccine safety, smoking cessation, and reducing environmental hazards, the IOM continues to advance the best ways to ensure the public’s health.



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Managing Threats and ensuring Healthy Communities: Health of the Public Public health is fundamental to every individual’s health. An Institute of Medicine (IOM) committee in 1988 described the mission of public health as fulfilling society’s interest in assuring conditions in which people can be healthy. Yet each individual’s health and well-being are shaped by the interactions of genetic endowment, environmental exposures, lifestyle and food choices, social conditions, income, and medical care. Collectively, these factors As a reflection of its broad shape health at the population level—the spectrum, public health is perhaps the most dierse domain of public health. As a reflection of its broad spectrum, area the IoM inestigates. public health is perhaps the most diverse area the IOM investigates. The studies deal with important—and some- times contentious—challenges that affect people from every walk of life, in every part of the country. Preenting disease, early detection, and effectie treatment Since its founding, the IOM has consistently stressed the value of preven- tion of disease, a core tenet of public health. In studies ranging from core principles and needs in the field to specific issues such as health disparities, vaccine safety, smoking cessation, and reducing environmental hazards, the IOM continues to advance the best ways to ensure the public’s health. 

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 INforMINg THe fuTure: Critical Issues in Health Improing accines In the United States and worldwide, vaccines have proved to be the most potent and cost-effective means of controlling infectious diseases. How- ever, vaccines have yet to achieve their full potential. In 1994, the U.S. government implemented a National Vaccine Plan that charted a route to more fully capture the promise of vaccines. Admin- istered by the National Vaccine Program Office (NVPO) of the Department of Health and Human Services, the plan had four main goals: to develop new and improved vaccines; to ensure the optimal safety and effectiveness of vaccines and immunization; to better educate the public and members of the health professions on the benefits and risks of immunizations; and to achieve better use of existing vaccines to prevent disease, disability, and death. The plan, which offered more than 70 strategies for achieving its objectives, has recorded numerous successes since its implementation. But recent years also have kindled awareness that the plan needs to be modified to meet new challenges and opportunities. Working in coordination with a number of federal agencies, the NVPO now is in the preliminary stages of updating the plan, and the part- ners turned to the IOM for assistance. Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office (2008) examines the goals, objectives, strategies, and anticipated outcomes of the original plan; explores how it was developed; and cri- tiques the initial draft update that was proposed. Based on this analysis, the report identifies six specific “content” areas in which technical aspects of the 1994 plan might be improved and four “methodology” areas that might be strengthened in the process of updating the plan. The report urges the inclusion of stakeholders beyond federal agencies in framing the plan’s scope, goals, and objectives. Additional con- tributors should include the pharmaceutical industry, insurers, health care providers and other purchasers of health care services, researchers across a range of basic and applied sciences, state and local public health agencies responsible for vaccine delivery, schools and day care centers, foundations and other not-for-profit organizations, the mass media, and, importantly, the public (including people with varying perspectives on the value of immunization), among others. Following the release of this initial guidance, the committee began its review of the draft update of the vaccine plan, which will be released late in 2009. It convened meetings of stake- holders in medicine, public health, and vaccinology to discuss the five goals laid out in the draft plan.

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 Managing Threats and ensuring Healthy Communities Academic MIDRC research NVPO enterprise (HHS) State governments Microbiology and Infectious Diseases Research Committee state, tribal, and local public health agencies NVAC NIH Vaccine National Vaccine Advisory (HHS) Industry Committee COPR CDC NIH Director’s Council of ACIP Public Representatives (HHS) Advisory Committee on Immunization Practices FDA VRBPAC Public (HHS) Vaccines & Related Biological Products Advisory Committee Primary care delivery system private and public ACCV HRSA Advisory Commission on CMS Childhood Vaccines (HHS) (HHS) Payers and Plans Figure 1 This figure is intended to illustrate some aspects of the immunization system’s complexity, not to be a complete description of the system. A number of federal advisory committees exist to provide advice and guidance to agencies in6-1 Federal advisory committees and Department of Health and Human Services (HHS) FIGURE the Department of Health and Human Services (DHHS). Several of these committees are associated with vaccine- or immunization-specific programor Four such committees, as well as two additional relevant committees are agencies associated with vaccine- s. immunization-specific programs. depicted in the figure. Legend: This figurerepresent federal agencies in the Department of Health and Human Services (DHHS) (other NOTE: Gray boxes is intended to illustrate some aspects of the immunization system’s complexity, dnot to be asuch as the Departments of Defense, Veteransnumber of Homeland Security,committees exist roles epartments, complete description of the system. A Affairs, and federal advisory also play important to in the immunizationand guidanceboxes represent federal advisory committees associated withas two agencies, and provide advice system); white to agencies in HHS. Four such committees, as well DHHS additional grelevant represent other are depictedAcronyms: CDC = Centers for Disease Control and Prevention; CMS = ray ovals committees, stakeholders. in the figure. Centers for Medicare & Medicaid Services; FDA = Food and Drug Administration; HRSA = Health Resources and Services Administration; NIH = National Institutes of Health; HHS (other departments, such Office. NDepart- Legend: Gray boxes represent federal agencies in NVPO = National Vaccine Program as the otes about the federal advisory committeesAffairs, ACCV includes attorneys for also play important roles in the ments of Defense, Veterans above: and Homeland Security, injured children and for industry; NVAC Includes public, industry, state public health, and healthfederal advisory committees associated with HHS and immunization system); white boxes represent care (AHIP) representation; ACIP includes public and state local public health representation and liaisons to the vaccine industry and professional associations; COPR includes agencies, and gray ovals represent other stakeholders. patients, family members of patients, health care and education professionals and members of the general public who advise the Director of the NIH onfor Disease Control andoutreach and participation in NIH’s research-related Acronyms: CDC = Centers “matters of public interest, Prevention; CMS = Centers for Medicare & activities”; VRBPAC includes public and nonvoting industry representation. Medicaid Services; FDA = Food and Drug Administration; HRSA = Health Resources and Services Administration; NIH = National Institutes of Health; NVPO = National Vaccine Program Office. ACCV includes attorneys for injured children and for industry; NVAC Includes public, industry, state public health, and health care (AHIP) representation; ACIP includes public and state and local public health representation and liaisons to the vaccine industry and professional associa- tions; COPR includes patients, family members of patients, health care and education profession- als and members of the general public who advise the Director of the NIH on “matters of public interest, outreach and participation in NIH’s research-related activities;” VRBPAC includes public and nonvoting industry representation. SOURCE: Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office, p. 9. For many years the IOM has been involved in evaluating evidence concerning adverse health effects that may be associated with specific vac- cines covered by the Vaccine Injury Compensation Program. In 2009, the IOM began a new study to review the epidemiological, clinical, and bio- logical evidence relating to the health effects of varicella zoster vaccine,

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 INforMINg THe fuTure: Critical Issues in Health influenza vaccines, hepatitis B vaccine, human papillomavirus vaccine, and possibly others. The upcoming reports will consider whether a specific vaccine is related to a specific adverse event. Helping to improe medication safety Each year, people taking medications as outpatients experience more than a million harmful consequences that result in a trip to a physician’s office or an emergency room. Sometimes, such adverse reactions lead to hospi- talization or even death. A patient’s first . . . research shows that nearly line of defense against medication hazards half of all patients hae is the label on the drug’s container that trouble understanding label provides information about the drug and instructions, either because how it should be taken. Yet research shows that nearly half of all patients have trouble of some type of literacy understanding label instructions, either limitation or because the because of some type of literacy limitation labels are poorly presented. or because the labels are poorly presented. The IOM’s Roundtable on Health Literacy examined this safety issue in a workshop that brought together a diverse array of participants, includ- ing representatives from government, the pharmacy field, the health care community, the research enterprise, and the pub- lic, among others. Standardizing Medication Labels: Confusing Patients Less: Workshop Summary (2008) surveys what is known about how medication con- tainer labeling affects patient safety and describes participants’ various suggestions for fixing the problem. Many patients do not understand current drug labels, but the best way to improve comprehension of medication instructions is unclear. Experts dif- fer in their judgments about exactly what informa- tion should be included on a drug label and how that information should be presented. Although there have been some tests of various types of labels, workshop participants concluded that more research is needed to find answers that are both broader and more pre- cise. There is also disagreement about whether regulation or a voluntary approach will best achieve label standardization, with some participants

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 Managing Threats and ensuring Healthy Communities Patient Misunderstanding of Medication Instructions Dosage Instruction Patient Interpretation Take one teaspoonful by Take three teaspoons daily mouth three times daily Take three tablespoons every day Drink it three times a day Take one tablet by mouth Take two pills a day twice daily for 7 days Take it for 7 days Take one every day for a week I’d take a pill every day for a week Take two tablets by mouth twice daily Take it every 8 hours Take it every day Take one every 12 hours SOURCE: Standardizing Medication Labels: Confusing Patients Less: Workshop Summary, p. 15. favoring each approach and arguing that the other has not been proven successful. In providing a possible way forward, the report offers a list of ques- tions for an expanded research program. What are the mechanisms by which standardization can be achieved? What would the process look like? What are the costs of standardizing? What level of evidence is needed to introduce a best practice? At the same time, care must be taken to ensure that steps to promote label standards do not detract from other efforts, such as education of both patients and physicians in matters of drug safety, that are needed to reduce medication errors. reducing enironmental and foodborne threats Many public health concerns stem from some type of agent that humans release into the environment. This release may result from the activities of society—for example, from industries that emit chemical pollutants—or from the actions of individuals, as in the instance of cigarette smoking. In either case, the public has an interest in better understanding and eliminat- ing all such hazards. reiewing great Lakes pollution studies The Great Lakes are magnificent—and environmentally critical—resources for both the United States and Canada. But many sections of the lakes are

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0 INforMINg THe fuTure: Critical Issues in Health contaminated with a variety of potentially hazardous pollutants. In 1972, the two nations signed the Great Lakes Water Quality Agreement to restore and maintain the lakes’ chemical, physical, and biological integrity. Under the agreement, the International Joint Commission monitors and assesses the nations’ activities, including efforts to protect human health from con- taminants. In 2001, the commission asked the Agency for Toxic Substances and Disease Registry (ATSDR), part of the U.S. Centers for Disease Control and Prevention (CDC), to evaluate the public health implications of hazard- ous materials present in U.S. portions of the lakes. (The commission also has worked with Health Canada to document conditions in Canadian waters.) After a first unsuccessful attempt, the ATSDR produced a draft report in 2007. Even then, registry officials had concerns about the meth- ods used and the conclusions drawn in the draft, and the registry released a revised draft report in 2008. This further revision attracted criticism of its scientific integrity, however, and the CDC asked the IOM to conduct an independent study. Review of the ATSDR’s Great Lakes Report Drafts: Letter Report (2008) concludes that both drafts have shortcomings that diminish U.S. and Binational Great Lakes Areas of Concern. NOTE: AOCs = Areas of Concern. SOURCE: Review of the ATSDR’s Great Lakes Report Drafts: Letter Report, p. 33.

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 Managing Threats and ensuring Healthy Communities their scientific quality and limit their usefulness in determining whether health risks might be associated with living near the lakes. The report item- izes a number of faults—often involving data selection—and explains their adverse consequences. Many of the problems appear to stem from the lack of a clear statement of objectives and an approach to reach those aims. The report suggests ways to approach similar tasks in the future. Such projects should begin by identifying the research questions to be answered or the tasks to be undertaken, and then should develop and document a detailed approach to answering those research questions. The group under- taking the project also should seek out other entities for partnering, such as federal agencies or state governments, as early in the process as possible. Improing food safety In support of strengthening the U.S. food safety system, IOM worked with the Division of Earth and Life Studies to help the U.S. Department of Agri- culture to improve its risk-based inspection system. Additionally, a con- gressionally mandated review of the Food and Drug Administration’s role in ensuring safe food is underway and will be completed by summer 2010. Improing emergency preparedness In today’s world, the United States must be prepared to respond to a vari- ety of hazards, both natural events and deliberate actions taken by other nations or terrorist groups. Ensuring a high degree of preparedness remains a never-ending concern. The IOM recognizes that preparing for emergen- cies and disasters is crucial to protecting the public’s health. The organiza- tion has devoted many resources to helping federal agencies prepare for national emergencies that may arise, with particular focus during the past few years on emerging diseases. In 2008–2009, the IOM held a workshop on the capacity of the health care system to treat an affected population in the case of a nuclear event; published a report discussing how the global health community can strengthen surveillance and response to emerging zoonotic diseases; and will release late in the year another report that evaluates the Department of Homeland Security’s BioWatch program, which is intended to detect airborne biological threats. Three previous IOM reports provide insights into how government might respond to an outbreak of pandemic influenza

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 INforMINg THe fuTure: Critical Issues in Health Key elements of Preparedness A prepared community is one that develops, maintains, and uses a realistic preparedness plan that is integrated with routine practices and has the following components: Preplanned and coordinated rapid-response capability 1. Health risk assessment. Identify the hazards and vulnerabili- ties (e.g., community health assessment, populations at risk, high-hazard industries, physical structures of importance) that will form the basis of planning. 2. Legal climate. Identify and address issues concerning legal authority and liability barriers to effectively monitor, pre- vent, or respond to a public health emergency. 3. Roles and responsibilities. Clearly define, assign, and test responsibilities in all sectors, at all levels of government, and with all individuals, and ensure each group’s integration. 4. Incident Command System (ICS). Develop, test, and improve decision making and response capability using an integrat- ed ICS at all response levels. 5. Public engagement. Educate, engage, and mobilize the pub- lic to be full and active participants in public health emer- gency preparedness. 6. Epidemiology functions. Maintain and improve the systems to monitor, detect, and investigate potential hazards, particularly those that are environmental, radiological, toxic, or infectious. 7. Laboratory functions. Maintain and improve the systems to test for potential hazards, particularly those that are envi- ronmental, radiological, toxic, or infectious. 8. Countermeasures and mitigation strategies. Develop, test, and improve community mitigation strategies (e.g., isola- tion and quarantine, social distancing) and countermeasure distribution strategies when appropriate.

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 Managing Threats and ensuring Healthy Communities 9. Mass health care. Develop, test, and improve the capability to provide mass health-care services. 10. Public information and communication. Develop, practice, and improve the capability to rapidly provide accurate and credible information to the public in culturally appropriate ways. 11. Robust supply chain. Identify critical resources for public health emergency response and practice and improve the ability to deliver these resources throughout the supply chain. Expert and fully staffed workforce 1. Operations-ready workers and volunteers. Develop and maintain a public health and health-care workforce that has the skills and capabilities to perform optimally in a public health emergency. 2. Leadership. Train, recruit, and develop public health leaders (e.g., to mobilize resources, engage the community, develop interagency relationships, and communicate with the public). Accountability and quality improvement 1. Testing operational capabilities. Practice, review, report on, and improve public health emergency preparedness by regularly using real public health events, supplemented with drills and exercises when appropriate. 2. Performance management. Implement a performance man- agement and accountability system. 3. Financial tracking. Develop, test, and improve charge capture,a accounting, and other financial systems to track resources and ensure adequate and timely reimbursement. Charge capture systems collect and analyze charges for medical care. a SOURCE: Research Priorities in Emergency Preparedness and Response for Public Health Systems: A Letter Report, p. 11.

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4 INforMINg THe fuTure: Critical Issues in Health or other infectious disease threats. These reports speak to the use of face masks and other personal protective equipment in health care settings. All emphasize the vital importance of meeting the needs of the health care workers and other front-line personnel who provide care for others during an influenza pandemic. As part of a national effort to ensure security, Congress in 2006 enacted the Pandemic and All Hazards Preparedness Act, which called for refocusing the research priorities of the network of Centers for Pub- lic Health Preparedness now operating at 27 accredited schools of pub- lic health nationwide. The federal government had created the centers in 1999 to provide expanded expertise to strengthen the nation’s emer- gency response systems, and the new law both refined and expanded that charge. To help with this restructuring, the agency that oversees the cen- ters, the Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER), which is part of the CDC, asked the IOM to develop a research agenda that can be carried out over the next 3 to 5 years. Research Priorities in Emergency Preparedness and Response for Public Health Sys- tems: A Letter Report (2008) proposes that the centers give priority to four general areas. These include research (1) to design and implement emer- gency preparedness training and for translating the results into public use, (2) to communicate accurate information in a timely manner to diverse audiences, (3) to create sustainable community-based preparedness sys- tems, and (4) to generate improved criteria and metrics for evaluating the performance of public health emergency response systems. Less than a month after the IOM released its report, COTPER issued a request for applications for research grants that incorporated almost verbatim the report’s findings and recommendations. COTPER expects to award nearly $9 million to projects that “investigate the structure, capabili- ties, and performance of public health systems for preparedness and emer- gency response activities.”