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This online archive of the CDC Prevention Guidelines Database is being maintained for historical purposes, and has had no new entries since October 1998. To find more recent guidelines, please visit the following:

National Action Plan to Combat Multidrug-Resistant Tuberculosis

U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Center for Prevention Services, Division of TB Elimination. From MMWR VOL.41(RR-11).

Publication date: 06/19/1992

Table of Contents




TB Control Programs
Increase in TB Cases
Drug-Resistant TB

Problem 1
Problem 2
Problem 3
Problem 4

Problem 5
Problem 6
Problem 7

Problem 8
Problem 9
Problem 10
Problem 11
Problem 12
Problem 13
Problem 14
Problem 15
Problem 16
Problem 17
Problem 18

Problem 19
Problem 20

Problem 21
Problem 22

Problem 23

Problem 24
Problem 25

Problem 26
Problem 27
Problem 28
Problem 29
Problem 30

Problem 31
Problem 32
Problem 33
Problem 34
Problem 35
Problem 36
Problem 37
Problem 38






Alan R. Hinman, M.D., M.P.H.
National Center for Prevention Services

James M. Hughes, M.D.
National Center for Infectious Diseases

CDC Representatives

Donald A. Berreth
Office of Public Affairs

Claire V. Broome, M.D.
Assistant Director for Science

James W. Curran, M.D., M.P.H.
Acting Deputy Director (HIV)

George E. Hardy, Jr., M.D., M.P.H.
Assistant Director
CDC Washington

Martha F. Katz
Office of Program Planning and Evaluation

Gene W. Matthews, J.D.
Legal Advisor to CDC and ATSDR
Office of General Counsel

J. Donald Millar, M.D., D.T.P.H.
National Institute for Occupational Safety and Health

Ray M. (Bud) Nicola, M.D.
Associate Director
Public Health Practice Program Office

E. Kenneth Powell, M.D., M.P.H.
Medical Epidemiologist
National Center for Environmental Health and Injury Control

Dixie E. Snider, Jr., M.D., M.P.H.
Division of Tuberculosis Elimination
National Center for Prevention Services

Rueben C. Warren, D.D.S., Dr.P.H.
Associate Director for Minority Health

Brian M. Willis, J.D.
Office of General Counsel

Agency Representatives

James R. Allen, M.D., M.P.H.
National AIDS Program Office

David W. Feigal, M.D., M.P.H.
Division of Anti-Viral Drug Products
Food and Drug Administration

Mark J. Goldberger, M.D,, M.P.H.
Supervisory Medical Officer
Division of Anti-Viral Drug Products
Food and Drug Administration

Harry W. Haverkos, M.D.
Acting Director
Division of Clinical Research
National Institute on Drug Abuse

James C. Hill, Ph.D.
Deputy Director
National Institute of Allergy and Infectious Diseases National Institutes of Health

Joseph P. Iser, M.D.
Associate Bureau Director for Clinical Affairs Bureau of Health Care Delivery and Assistance, Health Resources and Services Administration

Melissa A. McDiarmid, M.D., M.P.H.
Office of Occupational Medicine
Occupational Safety and Health Administration

Kenneth McDonald
Infectious Disease Coordinator
Federal Bureau of Prisons

Kenneth P. Moritsugu, M.D., M.P.H.
Medical Director
Federal Bureau of Prisons

Zeda F. Rosenberg, Sc.D.
Assistant to the Director
National Institute of Allergy and Infectious Diseases National Institutes of Health

Alex Ross, M.S.
Senior Health Policy Analyst
Office of Health Planning and Evaluation
Public Health Service

Sam S. Shekar, M.D., M.P.H.
Executive Medical Officer
Health Care Financing Administration

Bruce D. Tempest, M.D.
Indian Health Service

Alan I. Trachtenberg, M.D., M.P.H.
National Institute on Drug Abuse

Jerry Zellinger, M.D.
Medical Advisor
Health Care Financing Administration

John B. Bass, Jr., M.D.
Advisory Council for the Elimination of Tuberculosis

William J. Callan, Ph.D.
Association of State and Territorial Public Health Laboratory Directors

James L. Hadler, M.D., M.P.H.
Council of State and Territorial Epidemiologists

Lloyd F. Novick, M.D., M.P.H.
Association of State and Territorial Health Officials

Diane Sharma, Ph.D.
United States Conference of Local Health Officers

Arthur G. Thacher, M.P.H.
National Association of County Health Officials


AAP     American Academy of Pediatrics
ACET    Advisory Council for the Elimination of Tuberculosis
ADAMHA  Alcohol, Drug Abuse, and Mental Health Administration
AHCPR   Agency for Health Care Policy and Research
AIDS    Acquired immunodeficiency syndrome
ALA     American Lung Association
AMA     American Medical Association
ASD     Adult/Adolescent spectrum of disease surveillance system
ASTHO   Association of State and Territorial Health Officials
ASTPHLD Association of State and Territorial Public Health Laboratory Directors
ATS     American Thoracic Society
BCG     Bacille Calmette-Guerin
BHCDA   Bureau of Health Care Delivery and Assistance, HRSA
BOP     Bureau of Prisons
CBO     Community-based organization
CDC     Centers for Disease Control
CDER    Center for Drug Evaluation and Research, FDA
CDRH    Center for Devices and Radiological Health, FDA
CPCRA   Community Program for Clinical Research on AIDS
CSTE    Council of State and Territorial Epidemiologists
DATC    Drug abuse treatment centers
DAVDP   Division of Anti-Viral Drug Products, FDA
DOT     Directly observed therapy
EPO     Epidemiology Program Office, CDC
FDA     Food and Drug Administration
HCFA    Health Care Financing Administration
HEPA    High-efficiency particulate air (filter)
HICPAC  Hospital Infection Control Practices Advisory Committee
HIV     Human immunodeficiency virus
HRSA    Health Resources and Services Administration
HUD     Housing and Urban Development
IDSA    Infectious Disease Society of America
IND     Investigational New Drug
IRMO    Information Resources Management Office, CDC
LHD     Local health department
MDR-TB  Multidrug-resistant tuberculosis
NACHO   National Association of County Health Officials
NASADAD National Association of State Alcohol and Drug Abuse Directors
NCET    National Coalition for the Elimination of Tuberculosis
NCHS    National Center for Health Statistics, CDC
NCID    National Center for Infectious Diseases, CDC
NCPS    National Center for Prevention Services, CDC
NETSS   National Electronic Telecommunication Surveillance System
NIAID   National Institute for Allergy and Infectious Diseases, NIH
NIDA    National Institute on Drug Abuse, ADAMHA
NIH     National Institutes of Health
NIOSH   National Institute for Occupational Safety and Health, CDC
NJCIRD  National Jewish Center for Immunology and Respiratory Diseases
NPHHI   National Public Health and Hospital Institutes
OGC     Office of General Counsel, CDC and HCFA
OGD     Office of Generic Drugs, FDA
OHA     Office of Health Affairs, FDA
OOC     Office of the Commissioner, FDA
OOP     Office of Orphan Products, FDA
OPPE    Office of Program Planning and Evaluation, CDC
ORA     Office of Regulatory Affairs
OSHA    Occupational Safety and Health Administration, U.S. Department of Labor
OTI     Office for Treatment Improvement, ADAMHA
PAS     Para-aminosalicylic acid, an antituberculosis drug
PHLIS   Public Health Laboratory Information System
PHPPO   Public Health Practice Program Office, CDC
POE     Port of entry
PSD     Pediatric spectrum of disease surveillance system
RFA     Request for assistance
RVCT    Report of verified case of tuberculosis
SBIR    Small Business Innovation Research program
TBDS    Tuberculosis Database System
TIPS    Treatment Improvement Protocol Statements
USCLHO  United States Conference of Local Health Officers
USPHS   United States Public Health Service
UVGI    Ultraviolet germicidal irradiation


At no time in recent history has tuberculosis (TB) been as great a concern as it is today. TB cases are on the increase, and the most serious aspect of the problem is the recent occurrence of outbreaks of multidrug-resistant (MDR) TB, which pose an urgent public health problem and require rapid intervention. A Task Force composed of representatives of many federal agencies has developed a National Action Plan for addressing this problem. The Task Force identified a number of objectives to be met if MDR-TB is to be successfully combatted. These objectives fail under the categories of a) surveillance and epidemiology -- determining the magnitude and nature of the problem; b) laboratory diagnosis -- improving the rapidity, sensitivity, and reliability of diagnostic methods for MDR-TB; c) patient management -- effectively managing patients who have MDR-TB and preventing patients with drug-susceptible TB from developing drug-resistant disease; d) screening and preventive therapy -- identifying persons who are infected with or at risk of developing MDR-TB and preventing them from developing clinically active TB; e) infection control -- minimizing the risk of transmission of MDR-TB to patients, workers, and others in institutional settings; f) outbreak control; g) program evaluation -- ensuring that TB programs are effective in managing patients and preventing MDR-TB; h) information dissemination/ training and education; and i) research to provide new, more effective tools with which to combat MDR-TB.

The Action Plan lays out a series of activities to be undertaken at the national level. For each category, the Plan presents statements of problems to be overcome, followed by a summary of the objective to be achieved and steps to be carried out. For each implementation step, responsibility is assigned to the appropriate organization and startup dates are listed.


Tuberculosis (TB) is an infectious disease caused by the bacterium Mycobacterium tuberculosis, which is spread almost exclusively by airborne transmission. Although the disease can affect any site in the body, it most often affects the lungs. When persons with pulmonary TB cough, they produce tiny droplet nuclei that contain TB bacteria, which can remain suspended in the air for prolonged periods of time. Anyone who breathes air that contains these droplet nuclei can become infected with TB.

A person who becomes infected with the TB bacillus remains infected for years. Usually a person with a healthy immune system does not become ill, but is usually not able to eliminate the infection without taking an antituberculosis drug. This condition is referred to as "latent tuberculous infection." Persons with latent tuberculous infection are asymptomatic and cannot spread TB to others. Generally, a positive TB skin test is the only evidence of infection. About 10-15 million persons in this country are infected with M. tuberculosis. About 10% of otherwise healthy persons who have latent tuberculous infection will become ill with active TB at some time during their lives.

TB Control Programs

Our programs for controlling TB have two major arms. The first and highest priority is to detect persons with active TB and treat them with effective antituberculosis drugs. Effective treatment keeps the patients from dying of TB and stops the transmission of infection to other persons in the household, at the work site, or in the community. Treatment of active TB involves taking multiple antituberculosis drugs daily (or two or three times weekly) for at least 6 months. If the patient does not take the medications for the full treatment period, the disease may not be cured and may recur. If medications are not prescribed properly or taken regularly, the TB organisms can become resistant to the drugs, and drug-resistant TB may then be transmitted to other persons. Drug-resistant disease is difficult and expensive to treat. Thus, the most important step to prevent drug-resistant disease is to ensure that patients take all their medication. Directly observed therapy is the best way of ensuring patient compliance.

The second major control intervention is to detect and preventively treat persons who do not have active TB, but who have latent tuberculous infection and may be at high risk of developing active TB. With drug-susceptible TB, preventive therapy with isoniazid greatly reduces the risk of developing active TB. Preventive therapy requires treatment daily or twice weekly for a minimum of 6 months, and many patients do not complete a full course of therapy without direct observation.

Increase in TB Cases

The United States had a significant decline in the number of TB cases over the past several decades -- from >84,000 cases in 1953 to a nadir of approximately 22,000 cases in 1984. In 1987, the Department of Health and Human Services established an Advisory Committee (now Council) for the Elimination of Tuberculosis (ACET). In 1989, the ACET published the Strategic Plan for the Elimination of Tuberculosis in the United States. The Plan established a national goal of TB elimination (i.e., an incidence of <1 case per 1 million population) by the year 2010. An interim goal for the year 2000 is an incidence of 3.5 cases per 100,000 population.

Since the Strategic Plan was published, dramatic changes in the incidence and epidemiology of TB have jeopardized the goal of TB elimination. In 1984, the long-standing annual decline in TB cases abruptly ended, and from 1985 through 1991, approximately 39,000 more cases were reported than would have been expected had the previous downward trend continued.

Much of the recent increase in cases is believed to be due to TB among persons infected with human immunodeficiency virus (HIV). For HIV-infected persons who have latent tuberculous infection, the risk of developing active TB is 7%-10% per year. Even more dramatic is the effect seen when persons who are already infected with HIV become newly infected with M. tuberculosis. In two outbreaks in which HIV-infected persons were exposed to cases of infectious TB, 40% of the exposed persons developed active TB within a few months; thus, among such persons, active TB develops soon after infection and progresses rapidly, often resulting in death. Other groups at high risk for TB include persons in group or institutional settings, such as correctional facilities, shelters for the homeless, residential care facilities, nursing homes, and hospitals, where the environments may be conducive to airborne transmission of TB.

Drug-Resistant TB

Recently, drug-resistant TB has become a serious concern. In a recent survey in New York City, 33% of cases had organisms resistant to at least one drug, and 19% had organisms resistant to both isoniazid and rifampin, the two most effective drugs available for treating TB. When organisms are resistant to both isoniazid and rifampin, the course of treatment increases from 6 months to 18-24 months, and the cure rate decreases from nearly 100% to less than or equal to 60%.

Drug-resistant TB is not limited to New York. CDC recently conducted a nationwide survey of drug resistance among all TB cases provisionally reported during the first 3 months of 1991. Overall, 14.4% of these cases tested had organisms resistant to at least one antituberculosis drug, and 3.3% had organisms resistant to both isoniazid and rifampin. Furthermore, the drug resistance problem appears to be worsening. For example, from 1982 to 1986, only 0.5% of new cases were resistant to both isoniazid and rifampin; by 1991, this proportion had increased to about 3.1%. Among recurrent cases, 3.0% were resistant to both drugs during 1982-1986, but in 1991 this proportion had more than doubled, to 6.9%.

Against this background of increasing numbers of TB cases and increasing numbers of drug-resistant cases, a serious new phenomenon has appeared: out-breaks of multidrug-resistant (MDR) TB in institutional settings. From 1990 through early 1992, CDC, in collaboration with state and local health departments, investigated seven outbreaks of MDR-TB in hospitals and correctional facilities in Florida and New York. To date, these outbreaks have included >200 MDR cases. Virtually all these cases had organisms resistant to both isoniazid and rifampin, and some had organisms resistant to seven antituberculosis drugs. Most of the patients in these outbreaks were infected with HIV. Mortality among patients with MDR-TB in these outbreaks was high, ranging from 72% to 89%, and the median interval between TB diagnosis and death was short, from 4 to 16 weeks. In addition to hospitalized patients and inmates, transmission of MDR-TB to health-care workers and prison guards has also been documented; at least nine of these workers have developed active MDR-TB, and five of them have died.

The rise in drug-resistant TB and the outbreaks of MDR-TB are a manifestation of serious underlying problems in the health-care infrastructure in the United States. An increasing proportion of TB cases is occurring among persons who were born in another country or who are homeless, who have substance abuse problems or mental illness, or who have other socioeconomic or medical problems, such as HIV infection, that make compliance with therapy difficult. Yet, at the same time that the number and complexity of TB cases have been increasing, fiscal constraints in government at all levels have led to cutbacks in many TB control programs. As a result, health departments have not had adequate resources to place all potentially noncompliant patients on directly observed therapy or to bring outbreaks under control. There have been shortages of antituberculosis drugs and significant increases in their costs. Screening and preventive therapy have not been offered consistently to many groups at high risk of TB (e.g., HIV-infected persons) because of limited resources.

Several other factors have contributed to the outbreaks. The increasing incidence of TB in many areas is bringing more persons with active, infectious TB into institutional settings, such as health-care and correctional facilities, many of which serve populations in which there is also a high proportion of HIV-infected persons. This convergence creates an opportunity for transmission of TB, and many areas lack adequate facilities and practices for controlling the transmission of airborne disease or for adequately treating and managing TB patients. In addition, recognition of drug-resistant TB has often been delayed because current methods for diagnosing TB and performing drug susceptibility tests require weeks to months to complete. Furthermore, the selection of drugs available for treating TB is limited, which makes the treatment of drug-resistant cases particularly difficult.

In response to the emergence of MDR-TB, a federal Task Force was convened in December 1991 to develop a national plan to combat the problem. This document summarizes that plan by identifying the problems that need to be addressed, outlining the objectives for addressing each problem, and listing the implementation steps needed to attain each objective. Attached to each implementation step is a time frame for initiating the step. Many activities that are indicated as beginning in 1992 and 1993 will continue in subsequent years.

The National Action Plan does not replace the Strategic Plan for Elimination of Tuberculosis; rather, it identifies steps that need to be taken quickly to address the MDR-TB problem specifically. This plan is a blueprint for action by federal agencies. However, many of the implementation steps will depend on the cooperation of many sectors of society.


Determine the magnitude and nature of the problem.

To combat MDR-TB, it is first necessary to determine the magnitude of the problem and the factors that are associated with its spread. Surveillance involves collecting information about a condition, such as TB, that allows us to see trends in the disease over time and in specific geographic areas and provides an estimate of morbidity and mortality and a basis for allocation of resources. Although surveillance for TB has been ongoing for decades, it should be expanded to capture information necessary to track the emergence of multidrug resistance. Epidemiology includes studies that define the factors that promote or retard the development of a given disease, such as MDR-TB. Epidemiologic studies will help identify where MDR-TB is being spread, what activities are associated with increases or decreases in transmission, and which preventive strategies are effective.

Problem 1

National surveillance systems are inadequate to accurately determine the frequency and patterns of drug-resistant TB. Objective:

Develop nationwide surveillance systems for determining the drug susceptibility patterns of persons with active TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop a resolution to promote            CDC             1992
    routine drug-susceptibility            CSTE/ASTPHLD
    testing of M. tuberculosis
 2. Add reporting of drug-suscepti-            CDC             1993
    bility results to the CDC Report           CSTE
    of Verified Case of TB (RVCT)       TB control programs
    System, which collects data on
    persons with TB.
 3. Increase CDC support to states             CDC            1992-93
    for expansion of the RVCT surveil-
    lance system to collect additional
    information, such as results of
    drug-susceptibility testing.
 4. Develop the capacity to transmit           CDC            1992-93
    RVCT data electronically between
    state health departments and CDC
    to enable more rapid collection
    and dissemination of data on drug
 5. Develop a module to facilitate             CDC           Under way
    reporting of M. tuberculosis drug-       ASTPHLD
    susceptibility patterns by using
    the Public Health Laboratory Infor-
    mation System (PHLIS), which
    collects nationwide data on M.
    tuberculosis isolates processed in
    state public health laboratories.
 6. Develop a software package that            CDC            1992-93
    links TB management and surveil-           CSTE
    lance systems, including the Tuber-      ASTPHLD
    culosis Database System (TBDS),
    RVCT, National Electronic Telecom-
    munication Surveillance System
    (NETSS), and PHLIS datasets at the
    state level.
 7. Provide on-site support in computer        CDC            1992-93
    programming and use as needed to
    support TB data collection and

Problem 2

Hospitals, correctional facilities, and other institutional settings have been the focus of outbreaks of MDR-TB. The extent of MDR-TB transmission in the community has not been well studied. Epidemiologic studies and surveillance data are needed to assess the risk of infection and disease and factors promoting TB transmission in institutional settings, as well as the extent of community transmission.

Conduct epidemiologic investigations and studies to better define the scope and magnitude of the problem, to identify risk factors for transmission of TB in special settings, and to define the extent of MDR-TB transmission in the community.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Draft a coordinated approach to            CDC           Under way
    outbreak investigation, and define
    specific issues to be addressed in
    outbreak investigations (e.g.,
    quantitate disease attack rates
    among exposed persons).
 2. Investigate MDR-TB outbreaks in            CDC            Ongoing
    hospitals, other health-care        TB control programs
    facilities, prisons, other insti-
    tutional settings, and the
    community, as indicated.
 3. Enhance MDR-TB-related health              CDC            Ongoing
    hazard investigations and technical
 4. Consider collecting additional             CDC            1992-93
    information to identify exposures   TB control programs
    in high-risk settings (e.g.,
    correctional facilities).
 5. Conduct epidemiologic studies to           CDC            Ongoing
    identify risk factors for transmis-        BOP
    sion of MDR-TB in health-care faci-
    lities, correctional facilities,
    and other settings where there is
    risk of TB transmission.
 6. Collect information on contacts of         CDC            1992-93
    reported MDR-TB patients who have
    been identified, examined, and
    found infected, so that the inci-
    dence of MDR-TB infection can be
 7. Conduct epidemiologic studies to           CDC             1993
    define the extent of MDR-TB trans-
    mission in communities affected by
    MDR-TB outbreaks.
 8. Develop a model to forecast the            CDC            1992-93
    effect of MDR-TB on trends in TB
 9. Create a subcommittee of the Task          CDC            1992-93
    Force to assess and forecast the           HCFA
    economic impact of TB and MDR-TB          AHCPR
    and the costs of implementing this         OSHA
    Action Plan.

Problem 3

Certain subgroups of the population, including workers and clients of some service occupations, are at increased risk of TB. Data are needed to assess the risks and patterns of M. tuberculosis infection and active TB (both MDR-TB and drug-sensitive TB) among workers and others in settings where there is a risk of TB transmission. Objective:

Determine the patterns of TB disease and infection among workers and others in settings where there is a risk of TB transmission, and characterize current programs for TB infection screening and infection control in these settings.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Explore the feasibility of                 CDC            1992-93
    collecting and coding data on
    personal risk factors, including
    occupation, to allow determination
    of high-risk settings for MDR-TB.
 2. Perform a survey of hospital-based         CDC             1992
    TB-related activities, including
    skin-testing programs for workers,
    infection control standards, and
    laboratory capabilities.
 3. Develop a sentinel surveillance            CDC             1992
    program for TB infection among
    health-care workers to assess their
    risk of TB infection and the risk
    of active TB for those whose skin
    tests convert to positive.
 4. Perform a survey of TB-related acti-       CDC             1992
    vities (worker skin-testing programs,      BOP
    infection control standards, and          ADAMHA
    laboratory capabilities) in other
    high-risk occupational settings,
    including correctional facilities
    and drug-abuse treatment centers.
 5. Develop a TB infection sentinel sur-       CDC             1993
    veillance program to assess the risk       BOP
    of TB infection and active TB among       ADAMHA
    workers in other high-risk occupa-
    tional settings, including correc-
    tional facilities and drug-abuse
    treatment centers.
 6. Perform studies on risk factors for        CDC            1993-95
    TB infection among workers in             ADAMHA
    settings where surveillance programs
    document an excess risk of TB
    infection and active TB.

Problem 4

Persons with HIV infection have been the focus of recent MDR-TB outbreaks; however, the impact of HIV infection on TB trends has not been well characterized. Information is needed to assess the impact of HIV infection on recent trends in TB disease and infection, including MDR-TB, in the United States.
Objective A:

Characterize the HIV infection status of persons with TB and forecast the effect of HIV on future TB trends.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Obtain assurance of confidentiality        CDC             1992
    protection under Section 308(d) and
    301(d) of the Public Health Service
    Act for CDC surveillance activities
    that include information on the HIV
    status of persons with TB.
 2. Work with state and local health           CDC            1992-93
    departments to assure confiden-        State TB and
    tiality of TB/HIV information at    HIV control programs
    all levels. Such measures would
    include providing training to state
    and local health department staff
    on maintenance of confidentiality.
 3. Collect data on the HIV infection          CDC            1992-93
    status of TB patients reported         State TB and
    through the RVCT, in accordance     HIV control programs
    with state laws.                     HIV/AIDS surveil-
                                        lance coordinators
 4. Continue HIV serosurveys in sen-           CDC            Ongoing
    tinel TB clinics.
 5. Collect data on the HIV infection          CDC             1993
    status of TB patients through
    unlinked seroprevalence surveys
    in TB clinics.
 6. Collect data on TB exposure and            CDC             1993
    disease in cohorts of women and
    children in ongoing perinatal HIV
    transmission studies.
 7. Develop a model of TB/HIV co-infec-        CDC             1992
    tion to forecast the effect of HIV
    on TB morbidity trends.
Objective B:

Study drug-susceptibility patterns, treatment, and risk factors for TB among HIV-infected persons and perform surveillance of skin-test reactivity, anergy testing, and use of preventive therapy for persons with HIV infection.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Perform surveillance of TB testing         CDC            1992-93
    practices, TB disease, drug suscep-        NIH
    tibility, and use of preventive
    therapy among HIV-infected persons
    through modification of the existing
    Adult/Adolescent Spectrum of Disease
    (ASD) and Pediatric Spectrum of
    Disease (PSD) surveillance systems,
    and the Community Program for Clin-
    ical Research on AIDS (CPCRA) and
    its Observational Data Base. These
    systems monitor diseases occurring
    among persons with HIV infection.
 2. Expand cooperative agreement with the      CDC             1993
    National Public Health and Hospital       NPHHI
    Institutes (NPHHI).
 3. Enhance the HIV and AIDS reporting         CDC            1992-93
    system to collect supplemental TB     State HIV and
    data, including the drug-suscep-       TB programs
    tibility patterns of persons        HIV/AIDS surveillance
    reported to have TB.                   coordinators
 4. Add TB skin testing to the battery         NIH            1992-93
    of routine tests carried out in            CDC
    existing national and international
    AIDS epidemiology cohort studies to
    determine the relationship between
    diminished reactivity to the TB skin
    test and immunologic status and to
    analyze the incidence and prevalence
    of TB among HIV-infected women.


Make the laboratory diagnosis of MDR-TB more rapid, sensitive, and reliable.

Many laboratory techniques for the diagnosis of TB and for identification of drug resistance were developed in the 1950s and 1960s. Although more accurate, rapid, and sophisticated methods are now available, these techniques have not been widely implemented, as TB was thought to be a declining disease and resources were shifted away from mycobacteriology laboratories. Now that both TB and drug resistance are increasing, the most current technologies need to be applied to their fullest capacity.

Problem 5

The most rapid currently available laboratory technologies to identify MDR-TB are not in widespread use in state and local health department laboratories.

Increase the awareness and understanding of MDR-TB in the laboratory community, and upgrade the mycobacteriology capacity of state and local public health laboratories.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Conduct a survey of current labora-        CDC           Completed
    tory practices and capabilities in       ASTPHLD
    state and territorial mycobacteri-
    ology laboratories.
 2. Develop cooperative agreements with        CDC             1992
    state and local health departments
    to provide equipment and personnel
    to upgrade mycobacteriology labora-
 3. Develop state and regional laboratory      CDC             1993
    centers that can rapidly identify and
    determine drug susceptibilities of M.
    tuberculosis isolates.
 4. Develop a national specimen bank of        CDC           Ongoing
    MDR-TB isolates for use in profi-         ASTPHLD
    ciency testing and research.
 5. Explore upgrading the drug-                CDC             1993
    susceptibility proficiency testing
    program, in collaboration with the
    College of American Pathologists.
 6. Develop self-assessment tools for          CDC             1993
    laboratories to evaluate their
 7. Develop a proficiency testing module       CDC             1993
    to evaluate ability to use new tech-
 8. Expand Laboratory Performance Infor-       CDC            1993-98
    mation Exchange Systems for labora-
    tories to share information on new

Problem 6

As the outbreak spreads to more geographic areas, current laboratory capacity to track and characterize the epidemic of MDR-TB may not be adequate.

Enhance laboratory capacity to support outbreak investigations and special studies of MDR-TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Continue to support outbreak inves-        CDC            Ongoing
    tions through subtype characteriza-
    tion of isolates via DNA finger-
    printing and enhanced drug-suscepti-
    bility testing.
 2. Promulgate the use and transfer of         CDC            Ongoing
    proven, developed rapid diagnostic
    tests to clinical laboratories (e.g.,
    radiometric culture and suscepti-
    bility testing, high-performance
    liquid chromatography, nucleic acid
 3. Develop strategies to transfer tech-       CDC            Ongoing
    nologies for subtype characterization
    of isolates via DNA fingerprinting to
    state and city health departments, as

Problem 7

Approximately 700,000 aliens * apply for permanent resident status annually in the United States. Under provisions of the Immigration and Nationality Act, each of these persons must receive a medical examination that includes an examination for TB. The quality of laboratories used by examining physicians abroad may not be adequate to perform sputum smear examinations to identify infectious TB or to perform drug-susceptibility tests.

Evaluate the ability of these overseas screening laboratories to detect acid-fast bacilli, identify M. tuberculosis, and carry out drug-susceptibility tests; enhance their capability as needed.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Identify the top 20 immigrant visa-        CDC             1992
    processing posts abroad (in terms of
    the number of visas issued) with a
    high incidence of TB in the indi-
    genous population.
 2. Evaluate the TB diagnostic capabilities    CDC             1992
    of laboratories used by examining
    physicians and identify those that
    require upgrading.
 3. Provide any training necessary to          CDC             1993
    upgrade laboratory proficiency in
    collecting sputum, identifying
    positive sputum smears, identifying
    the TB bacillus, and performing
    drug-susceptibility tests.
 4. Provide oversight, proficiency             CDC            Ongoing
    testing, and consultation to ensure
    adequate TB diagnostic and drug-
    susceptibility testing capability.


Prevent patients with drug-susceptible TB from developing drug-resistant disease. Effectively manage patients who have developed drug-resistant disease.

A generation ago, TB was a common problem that most physicians had experience in treating. With the decline of TB, this expertise was lost. In addition, the lack of health-care coverage for a large segment of our society has led to inadequate resources for treatment of many patients with TB, including MDR-TB. Moreover, drug resistance has made treatment much more complicated and expensive. Thus, we need to upgrade our national ability to provide optimal treatment for all patients.

Problem 8

TB treatment must be given for a minimum of 6-9 months. If TB patients do not complete therapy, they may not be cured, and if they take medications incorrectly, the organisms may become drug resistant. Therefore, TB patients need some degree of supervision to ensure compliance with and completion of therapy.

Provide guidance regarding a step-wise approach to assure completion of therapy for all TB patients, with particular emphasis on implementation of directly observed therapy (DOT).

                                           Responsible         Start
Implementation steps                       organization        date
 1. Increase CDC grant-supported DOT.          CDC            1992-95
 2. Encourage state- and locally               CDC            1992-95
    supported DOT.
 3. Expand use of the CDC Outreach             CDC            Ongoing
    Training Course that promotes
    enhanced compliance/DOT.
 4. Recommend DOT policies for TB              ACET           1992-95
    programs, with emphasis on areas
    with a high prevalence of drug-
    resistant disease.
 5. Foster Medicaid and other third-           HCFA            1993
    party funding for DOT. Encourage DOT       HRSA
    in primary care facilities, drug          ADAMHA
    treatment centers, HIV/AIDS residen-
    tial facilities, HIV clinics, migrant
    clinics, and shelters.
 6. Promote the use of DOT by health-care      NCET           Ongoing
    providers.                                 CDC
 7. Issue new CDC/American Thoracic            ATS             1992
    Society/Infectious Disease Society of      CDC
    America/American Academy of Pediat-        IDSA
    rics Treatment Statement emphasizing       AAP
    extensive use of DOT.
 8. Provide ongoing technical assistance,      CDC            Ongoing
    both on-site and telephone, to
    promote expanded use of DOT in the
    field, as well as in clinics and
    other sites, by health departments
    and other health-care providers, e.g.,
    community-based organizations (CBOs),
    Visiting Nurse Association, and
    correctional facilities.
 9. Include DOT workshop at National TB        CDC             1992
    Conference.                               ADAMHA
10. Perform a survey of state and local        CDC             1993
    health departments to identify addi-      ADAMHA
    tional approaches being used to en-
    hance patient compliance (including
    use of incentives and treatment in
    special settings, e.g., shelters for
    the homeless, long-term hospitali-
    zation, drug-abuse treatment sites,
    court-ordered DOT, and quarantine).
11. Contract to study effectiveness and        CDC             1993
    cost-effectiveness of various TB          ADAMHA
    treatment strategies, including DOT
    in the field, DOT in clinics, DOT in
    special settings such as drug-abuse
    treatment sites, and use of incentives.

Problem 9

Approximately 700,000 aliens apply for immigrant visas abroad annually. Many of these applicants live in countries that have a high incidence of MDR-TB because of inadequate programs for managing and treating persons with TB.

To decrease the likelihood of introduction of MDR-TB to the United States, evaluate the feasibility of establishing DOT programs in four or five of the countries from which a high volume of immigration originates and which have a high incidence of TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Study feasibility of establishing DOT      CDC             1993
    programs in four or five countries
    with high incidence of TB from which
    a high volume of immigrants originate.
 2. Work with the Departments of State and     CDC             1993
    Justice to develop and implement DOT
    programs overseas.
 3. Work with clinics and physicians who       CDC             1994
    examine a high volume of immigrants
    to implement pilot DOT programs for
    visa applicants.
 4. Evaluate the efficacy of pilot DOT         CDC             1994
 5. Continue providing oversight, consul-      CDC            Ongoing
    tation, and evaluation for successful
    DOT programs overseas.

Problem 10

Few inpatient facilities are available for long-term treatment of patients with complicated TB cases, particularly those with MDR-TB, and many areas do not have a method of paying for these services. Objective:

Explore varying options for long-term institutionalization of TB patients, including patients with MDR-TB, and assist health departments in securing Medicare, Medicaid, and other funds for financing institutional care.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Respond to requests from states for        CDC            Ongoing
    possible solutions when problem cases
 2. Prepare an options paper for handling      CDC             1992
    persons in need of long-term hospi-        HCFA
    talization, addressing cost issues.       ADAMHA
 3. Survey state health departments for        CDC             1992
    information on available facilities        HCFA
    and current state practices regarding     ASTHO
    Medicare or Medicaid payment for TB
 4. Review findings of the survey and          CDC             1992
    examine possibility of expanding           HCFA
    Medicare or Medicaid coverage to          ADAMHA
    include all TB or MDR-TB patients in       HRSA
    need of institutionalization.
 5. Determine need for revised rules,          CDC             1993
    regulations, and policy for paying         HCFA
    for long-term treatment of patients
    with complicated TB cases. Develop
    and implement a strategy.
 6. Disseminate findings from the survey,      CDC             1993
    recommend options for long-term            HCFA
    institutionalization, and provide
    information to states on how to secure
 7. Review HCFA policies relevant to           HCFA          Under way
    inpatient treatment of patients with       CDC
    TB. Identify need for modifications.

Problem 11

Many TB patients do not have health insurance. Local health department budgets have difficulty providing adequate services to all who need them. Resultant breaks in the continuity of care may lead to the development of drug-resistant disease.

Find means to pay for outpatient services to persons who do not have third-party coverage.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Identify types of patients who could       HCFA            1992
    qualify for Medicaid/Medicare coverage
    for preventive or curative services.
 2. Identify types of curative or preven-      HCFA            1992
    tive services that could qualify for
    Medicaid/Medicare coverage.
 3. Distribute memorandum to regional and      HCFA            1992
    state Medicaid/Medicare offices outlin-
    ing HCFA policy concerning payment of
    claims for TB preventive or curative
 4. Explore means for reimbursement of TB      CDC             1993
    preventive services that are not           HRSA
    currently covered by Medicaid/Medicare.    HCFA
 5. Notify regions, states, large cities,      CDC             1992
    and territories about federal policy
    concerning Medicaid and Medicare
    coverage for preventive and curative
    TB services.
 6. Seek advice from the Social Security       CDC             1992
    Administration on the possibility of       HCFA
    modifying the Disability Definitions
    to include TB.
 7. Initiate discussions with private          CDC             1992
    insurers to explore options for
    funding TB treatment and prevention.

Problem 12

TB patients, particularly those with MDR-TB, often require specialized services that are difficult to provide in all acute-care hospitals and outpatient clinics.

Evaluate the feasibility of developing specialized inpatient and outpatient TB treatment units and regional inpatient treatment centers.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Work with selected health depart-          CDC             1993
    ments to explore the advantages and
    disadvantages of specialized TB
    treatment units.
 2. Work with selected health depart-          CDC            1992-93
    ments to explore third-party reim-         HCFA
    bursement mechanisms for care in
    specialized TB treatment units.
 3. Work with selected health depart-          CDC            1993-95
    ments, acute-care institutions, and
    medical schools to establish a number
    of regional centers of excellence
    for treating difficult-to-manage TB
    cases, especially patients with MDR-TB.

Problem 13

Drugs needed to treat TB, particularly MDR-TB, are often unavailable, and some of them are expensive, which may be an obstacle to effective treatment.

CDC, Food and Drug Administration (FDA), pharmaceutical manufacturers, and others will work together to assure an ongoing supply of currently licensed antituberculosis drugs at an acceptable cost.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop and maintain a list of all         FDA            Ongoing
    current manufacturers of bulk and
    finished TB drugs.
 2. Contact manufacturers to inform them       FDA            Ongoing
    of the increase in TB and MDR-TB and
    ask them to notify FDA if they anti-
    cipate manufacturing and/or supply
    problems or if they contemplate
    leaving the market.
 3. Develop active surveillance of             FDA            Ongoing
    pharmaceutical manufacturers to anti-
    cipate manufacturing and/or supply
    problems or if they contemplate
    leaving the market.
 4. Restore stable supplies of isoniazid,      FDA            October
    streptomycin, and para-aminosalicylic                      1992
    acid (PAS) on a long-term basis.
 5. In the interim, assure adequate            FDA            Ongoing
    supplies and distribution of strepto-      CDC
    mycin and PAS through an Investiga-
    tional New Drug mechanism until
    relicensing occurs.
 6. Provide information to the FDA Task        CDC            Ongoing
    Force on antituberculosis drug needs,
    trends in TB morbidity, and other
    related matters.
 7. Establish surveillance of existing         CDC            Ongoing
    antituberculosis drug supplies, needs,
    and costs in a representative sample
    of state and local health departments.
 8. Explore feasibility of a federal           CDC            1992-95
    contract to provide antituberculosis
    drugs to state and local health

Problem 14

Laws, regulations, and/or procedures for the quarantine, detention, reporting, and treatment of patients may be out of date or inadequate as the epidemiology of TB continues to evolve. Objective:

Develop guidelines and recommendations that address the legal issues of TB control.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Review current federal and state laws      CDC             1992
    and regulations on quarantine,             FDA
    reporting, treatment, and court-          ADAMHA
    ordered DOT of TB patients.
 2. Develop draft recommendations or           ACET            1992
    guidelines for when and how to             CDC
    report, treat, and obtain court           ADAMHA
    orders for DOT and quarantine of
    noncompliant patients.
 3. Seek comments on recommendations           CDC             1992
    and guidelines from state and local
    TB control officials, health depart-
    ment legal offices, ASTHO, ACET, and
    others as appropriate.
 4. Publish recommendations and guide-         ACET            1993
    lines.                                     CDC

Problem 15

Homeless TB patients are often not able to complete TB therapy because of lack of stable housing and need for other social services; as a result, drug-resistant disease may develop.

TB patients who are homeless, have unstable living arrangements, or lack essential social services will have access to housing for the duration of their TB treatment and will receive assistance with social services.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Alert Housing and Urban Development        CDC             1992
    (HUD) and others who provide social        HRSA
    services to the homeless about the
 2. Arrange a meeting involving represen-      CDC             1992
    tatives of CDC, HUD, HRSA, and
    consortia authorized under the
    Comprehensive AIDS Resources Emer-
    gency Act of 1990 (also called the
    Ryan White Act) to explore this issue.
 3. Assist state and local TB control          CDC            Ongoing
    programs in identifying local solutions
    to lack of housing for TB patients.
    Collect and disseminate information
    on successful strategies used in
    different areas.

Problem 16

TB among migrant and seasonal farm workers may be undiagnosed and inadequately treated because of lack of stable housing, the unique work situation, and geographic mobility; as a result, drug-resistant disease may develop.

Coordinate public health systems so that migrant and seasonal farmworkers have access to diagnosis and treatment.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Publish recommendations for                ACET            1992
    prevention and control of TB
    among migrant workers.
 2. Assist state and local governments,        HRSA           1992-93
    along with constituency groups, to        ASTHO
    develop better tracking systems     Migrant Clinicians
    for migrant and seasonal workers.        Network
 3. Coordinate services and                   ASTHO           1993-95
    reimbursement -- statewide and      Migrant Clinicians
    interstate -- among state health         Network
    offices, local health offices, and    USPHS Regional
    migrant health centers.                  Offices

Problem 17

TB patients who have substance abuse problems are likely to be noncompliant with TB therapy and may develop drug-resistant disease as a result.
Objective A:

Improve patient compliance with antituberculosis regimens among substance abusers in drug-abuse treatment centers.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Alert ADAMHA grantees and others          ADAMHA          Ongoing
    who receive ADAMHA publications
    about the emerging MDR-TB problem.
 2. Provide guidelines to drug-abuse          ADAMHA         September
    treatment providers on how to detect,      HRSA            1992
    prevent, treat, and report TB among
    their clients (Treatment Improvement
    Protocol Statements {TIPS} program).
 3. Provide training to substance abuse        CDC           September
    treatment staff on TB detection and       ADAMHA           1992
    management.                                HRSA
 4. Encourage cooperation between drug-       ADAMHA           ASAP
    abuse treatment centers (DATC) and         CDC
    local health departments for timely        HRSA
    notification when persons with active
    TB in drug-abuse treatment are lost
    to follow-up.
 5. Develop a system to track patients        ADAMHA           1993
    who receive services at different          LHD
    DATC sites to ensure that there is         DATC
    no break in their TB treatment
 6. Strongly encourage all ADAMHA grant-      ADAMHA          Ongoing
    ees to include TB screening and            HRSA
    preventive services in grant appli-
 7. Develop a Request for Assistance          ADAMHA           1993
    (RFA) to assess the extent of TB
    infection and disease among substance
    abusers both in and out of DATC,
    assess the rates of compliance with
    antituberculosis medications, and
    study innovative methods to enhance
    compliance among substance abusers.
Objective B:

Improve patient compliance with antituberculosis regimens among substance abusers not in drug-abuse treatment programs.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop a system that encourages           CDC             1993
    persons at high risk (including sub-       LHD
    stance abusers not in DATC) to come       ADAMHA
    for TB prevention and treatment ser-       DATC
    vices, provides such services, and
    ensures patient compliance.

Problem 18

Approximately 700,000 aliens apply for permanent resident status annually. A large percentage of these applicants come from countries where TB (including MDR-TB) is common. Under provisions of the Immigration and Nationality Act, many aliens with active TB are admitted to the United States with a waiver of excludability. When such persons arrive at a U.S. port of entry (POE), CDC staff notifies state and local health authorities at the final destination. However, CDC does not have staff at all major POEs and must rely on the Immigration and Naturalization Service staff to provide copies of the aliens' medical documentation so that health authorities can be notified. Consequently, notification on some aliens arriving with TB is missed, with resultant breaks in continuity of care and possible development of drug-resistant disease.

Improve the process of notifying state and local health departments about aliens arriving with TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Identify the top 10 immigrant-             CDC             1992
    processing POEs not currently staffed
    by CDC.
 2. Assign part-time staff to the top 10       CDC             1993
    POEs to coordinate TB medical docu-
    mentation and notification.


Identify persons who are infected with or at risk of developing MDR-TB and prevent them from developing clinically active TB.

In addition to treating patients with active TB, patients who are infected with the TB organism but are not yet sick must be treated. Because many persons remain in this latent stage for years and then develop active disease, treatment of such persons will prevent many future cases of TB. In the treatment of active TB, noncompliance with therapy leads to the development of drug-resistant disease; however, this problem can be reduced by preventing active disease from developing. In addition, the development of active disease among persons infected with MDR-TB can be reduced if a standard approach to the evaluation and management of persons exposed to MDR-TB can be developed.

Problem 19

A standard approach to the evaluation and management of persons exposed to MDR-TB is lacking.

Develop and publish an approach to the evaluation and management of persons exposed to MDR-TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop and disseminate guidelines         CDC             1992
    for evaluating and managing persons
    exposed to MDR-TB.

Problem 20

Many persons in populations at high risk for TB may also be at risk for noncompliance with therapy if active TB develops; as a result, drug-resistant TB may develop.

Implement screening and preventive therapy programs, including supervised preventive therapy, among populations at high risk for both TB and noncompliance.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Expand existing demonstration projects     CDC             1993
    for promoting skin testing and preven-     BOP
    tive therapy for clients in drug          ADAMHA
    treatment programs and inmates in
    correctional facilities.
 2. Expand screening for TB and tubercu-       CDC             1993
    lous infection to include all immi-
    grants and refugees. Consider adding
    tuberculin skin testing to the medical
    evaluation of aliens.
 3. Develop recommendations for each local     CDC             1993
    area to maximize participation of         ADAMHA
    drug abusers in drug-abuse treatment      NASADAD
    services and TB diagnostic, preven-
    tive, and treatment services.
 4. Initiate an RFA for TB outreach demon-    ADAMHA           1993
    stration projects to screen and place
    drug abusers on preventive therapy in
    several areas of the country.
 5. Develop a uniform database and track-      CDC             1992
    ing system for screening and preven-      ADAMHA
    tive therapy in DATC and correctional       BOP


Minimize the risk of transmission of MDR-TB to patients, workers, and others in institutional settings.

TB is spread by an airborne route, and anyone who breathes air containing tubercle bacilli is at risk for acquiring infection. Because persons caring for and persons exposed to TB patients are at high risk of acquiring TB from their infectious patients, special precautions must be taken to prevent such spread while the best possible care for the patient is maintained.

Problem 21

Various infection control strategies are available to prevent TB transmission in institutional settings. These strategies are not consistently implemented, and their effectiveness and feasibility are not well characterized.

Assess the effectiveness and feasibility of various infection control strategies in institutional settings (e.g., health-care facilities, substance abuse clinics, residential treatment centers, shelters for the homeless, correctional facilities) and ensure that appropriate procedures are implemented through educational and regulatory approaches.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Review the efficacy and cost-              CDC            1992-93
    effectiveness of isolation strategies.
 2. Identify and prioritize TB infection       CDC            1992-93
    control procedures appropriate for
    hospitals and outpatient settings
    providing care to patients who are
    at high risk for TB or who are known
    or suspected to have active TB.
 3. Update and revise the December 7,          CDC             1993
    1990, CDC infection control guide-        HICPAC
    lines with new information and clari-
    fication as needed, including the
    roles of ventilation, ultraviolet
    germicidal irradiation (UVGI), and
    respiratory protection.
 4. Develop a statement on issues related      CDC             1992
    to HIV-infected health-care workers       HICPAC
    and TB.
 5. Update statement on the role of BCG        CDC             1992
    vaccination in the control of TB,          ACIP
    with focus on health-care workers.         ACET
 6. Develop guidelines for selection and       CDC             1992
    use of respiratory protective devices     HICPAC
    for protection against infection with
    M. tuberculosis.
 7. Develop recommendations for design,        CDC             1993
    application, installation, monitoring,    HICPAC
    and maintenance of UVGI fixtures.
 8. Develop guidelines for effective envi-     CDC             1993
    ronmental TB prevention measures for       BOP
    use in correctional facilities and        ADAMHA
    drug-abuse treatment settings.
 9. Inspect substance-abuse centers, shel-    State            1993
    ters for the homeless, and health-care     and
    facilities on request to determine the    local
    adequacy of ventilation, so that the       HDs
    probability of TB transmission can be      CDC
    minimized.                                 OSHA
10. Perform cost analysis of modifying         OSHA            1993
    existing health-care, correctional,        CDC
    and other high-risk institutional          BOP
    facilities (including drug-abuse          ADAMHA
    treatment settings) to achieve com-
    pliance with infection control
11. Review OSHA requirements for TB in-        OSHA            1992
    fection control in health-care facil-      CDC
    ities, including drug-abuse treatment
    facilities, and other institutional
    settings, and suggest modifications
    and/or additions to the requirements.
12. Develop a Joint Advisory Notice be-        OSHA            1992
    tween the Department of Health and         CDC
    Human Services and the Department
    of Labor on protection of workers
    against occupational TB transmission.
13. Develop a guidance document for            OSHA            1992
    OSHA compliance officers.                  CDC
14. Enforce compliance with the General        OSHA           Ongoing
    Duty Clause for worker protection
    against TB transmission.

Problem 22

Tuberculin skin testing of workers in settings where there is a risk of TB transmission is very important. Skin testing identifies workers who are infected with M. tuberculosis and need to be evaluated for active TB and for preventive therapy. It also serves as an indicator of the effectiveness of infection control practices. However, tuberculin skin-testing programs are not consistently implemented.

Ensure that adequate tuberculin skin-testing programs for workers are in place in settings where there is a substantial risk of TB transmission.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Propose to the Joint Committee on          CDC             1992
    Accreditation for Health Organiza-
    tions the use of TB skin-test conver-
    sion rates among health-care workers
    as an outcome measure of the effec-
    tiveness of TB infection control
    programs in health-care facilities.
 2. Develop recommendations for state          CDC             1992
    regulations requiring periodic TB
    skin testing of health-care workers
    (excepting only those with documented
    positive TB skin tests or histories of
    previous treatment for TB).
 3. Develop recommendations for state          CDC             1992
    regulations requiring annual TB skin
    testing for corrections officers and
    other workers in high-risk institu-
    tional settings other than health
    care (e.g., shelters for the homeless).
 4. Review state regulations regarding         CDC             1992
    certification for persons providing        BOP
    TB screening at health-care or correc-
    tional facilities. Develop recommen-
    dations for state regulations.
 5. Support health departments in              CDC             1993
    recruitment and assisting hospi-    TB control programs
    tals, correctional facilities, and        ADAMHA
    drug-abuse treatment settings to          NASADAD
    develop, institute, and demonstrate
    the effectiveness of programs for
    systematic serial tuberculin skin
    testing of workers.


Control outbreaks of MDR-TB.

Because transmission of TB may not be immediately recognized, common-source outbreaks can occur. Such outbreaks represent a challenge to public health efforts to control TB. Strategies for control of outbreaks include rapid identification, isolation, and treatment of infectious TB patients, evaluation of exposed persons for subclinical or latent disease, and preventive therapy for persons at high risk for infection. Such public health strategies have been complicated by the emergence of drug resistance, and some existing strategies may need to be modified.

Problem 23

The control of MDR-TB outbreaks is costly and complex, requiring close collaboration among local, state, and federal health officials and others (e.g., hospital officials, correctional facility officials, technical consultants).

Facilitate collaboration of various officials and organizations in controlling MDR-TB outbreaks.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop more sensitive mechanisms to       CDC            Ongoing
    identify outbreaks (see page 10).
 2. When MDR-TB outbreaks occur, estab-        CDC            Ongoing
    lish an outbreak control team to
    facilitate collaboration among various
    health officials, agencies, and tech-
    nical consultants.
 3. Provide consultation to health depart-     CDC            Ongoing
    ments and institutions to facilitate
    control of outbreaks.


Evaluate TB control programs to be sure they are effective in managing patients and preventing the development of MDR-TB.

An important part of the TB control effort is continuous evaluation of the effectiveness of existing control programs. Thus, methods to identify and correct problems in control programs must be developed before such problems result in the spread of disease, especially MDR-TB.

Problem 24

Some TB control programs may not be effective in managing TB patients, which may allow drug-resistant disease to develop. There is a need for assessing the quality of TB control (including health department infrastructure, facilities, and priorities). Objective:

CDC, in conjunction with other agencies (e.g., the American Lung Association {ALA}, other members of the National Coalition for Elimination of TB), will assist state and local health departments in assessing the adequacy of their TB control programs.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Enlist as many other organizations  National TB Coalition  1993
    (e.g., AMA, local or state medical
    societies, public health associa-
    tions, nursing associations,
    laboratory groups) as possible to
    encourage senior government
    officials (e.g., mayors, governors,
    legislators, health department
    directors) to request program
    reviews to assess the efficacy of
    TB control programs.
 2. Encourage state TB control programs        CDC             1993
    work with ALA affiliates to arrange        ALA
    and support these reviews.
 3. Develop criteria for a model TB            ACET           1992-93
    control program.                           CDC
 4. Develop an evaluation instrument,          ACET           1992-93
    based on the criteria for a model TB       CDC
    control program, to be used as a
    framework for conducting program
 5. Conduct TB program reviews on 15-20        CDC            1993-94
    TB control programs in areas with          ALA
    the highest incidence of TB.               ATS
 6. Ensure that the results of these    State and local       Ongoing
    reviews are shared with senior         TB control
    government officials (e.g., health      programs
    department directors, mayors,           State TB
    governors, legislators).               elimination
 7. Assure that all state and large            CDC            Ongoing
    metropolitan TB control programs
    prepare and submit program management
    reports to CDC. (These reports
    measure the efficacy of control
 8. Evaluate TB control programs (five         CDC             1993
    with the highest indices and five
    with the lowest indices of completion
    of curative therapy) to develop a
    composite of the elements included in
    a successful TB control program, and
    share this composite nationally.

Problem 25

Poor compliance with prescribed treatment promotes the development of drug-resistant strains of M. tuberculosis, which may lead to outbreaks of MDR-TB. Programs do not currently collect and analyze data on treatment outcomes that would identify populations at high risk for treatment failure.

Assess program performance by collecting information on treatment outcomes of TB patients on an individual case basis, which will allow more effective targeting of resources.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Expand RVCT to collect information on      CDC             1993
    treatment outcome (e.g., continuity
    and completion of therapy).


Effectively disseminate information about MDR-TB and its prevention and control.

Because the incidence of TB had been declining before its recent increase, many groups do not have adequate information on prevention, treatment, control, or laboratory procedures related to the disease. Information and communication systems need to be developed to deliver expanded training and education to health-care workers and laboratorians, and methods for disseminating educational information to populations most heavily affected and to the general public need to be developed or improved.

Problem 26

Expertise regarding treatment of TB, especially MDR-TB, is lacking in many parts of the United States.

Develop a cadre of health-care professionals with expertise in the management of TB, including MDR-TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Increase knowledge about TB among          NCET           Ongoing
    health-care providers. Direct efforts      CDC
    at all levels of training, including       HRSA
    undergraduate and postgraduate levels.    NJCIRD
    Address content of textbooks, medical
    and nursing school curricula, residency
    and fellowship training, and continuing
    medical education.
 2. Provide supplemental training for          CDC             1993
    health-care providers in special           HRSA
    settings (e.g., drug treatment             ACET
    programs, migrant clinics, HIV treat-     ADAMHA
    ment and prevention centers) regarding
    treatment and prevention of TB, with
    special emphasis on compliance and
    adverse reactions to therapy.
 3. Work with medical schools and other        CDC             1993
    organizations to develop a cadre of        NCET
    health professionals with expertise       NJCIRD
    in management of MDR-TB to staff
    specialized TB units and regional
    centers of excellence.

Problem 27

Nosocomial transmission of TB to health-care workers and patients is occurring. Such transmission is preventable if recommended infection control practices are implemented.

Disseminate information on the prevention of TB transmission to individuals and in facilities that provide services to persons who already have TB or who are at high risk for it.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Identify populations most heavily          CDC            1992-93
    affected for educational intervention      HRSA
    (e.g., infection control practi-           NCET
    tioners, infectious disease physicians,
    primary care practitioners, hospital
    epidemiologists, and TB nurse consul-
    tants and program managers in state
    and metropolitan health departments).
 2. Develop curricula and materials on TB      CDC            1992-93
    infection control, principles of TB
    transmission, and techniques for
    improving communication between health
    departments and infection control prac-
    titioners in hospitals and correctional
    health settings.
 3. Work with other professional and aca-      CDC            1993-95
    demic groups to provide TB infection
    control training.
 4. Establish infection control training       CDC            1993-95
 5. Develop educational materials for          CDC            1993-95
    engineers and safety and health
    specialists about TB infection control
 6. Conduct regional workshops for training    CDC            1993-96
    consultants in infection control
    technology, design, installation, and

Problem 28

A critical need exists for trained researchers to develop new diagnostic assays, therapeutic agents, and vaccines to meet present and future TB public health needs.

Train adequate numbers of researchers to respond effectively to TB research needs.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Establish TB research training programs    NIH             1993
    for new investigators (postdoctoral
    fellowships and career development
    awards) and for senior investigators
    (senior fellowships and visiting
    fellowships at the National Institutes
    of Health {NIH}).

Problem 29

Mycobacteriology laboratory personnel may not be familiar with state-of-the-art TB diagnostic technologies and reporting practices. Objective:

Provide training and evaluation of clinical mycobacteriology laboratory personnel in new diagnostic techniques for TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Utilize the National Laboratory            CDC            Ongoing
    Training Network to train mycobacter-
    iology laboratory personnel in new
    diagnostic techniques.
 2. Develop appropriate training materials     CDC            Ongoing
    on TB for use in the laboratory
    setting, including new and emerging

Problem 30

Strategies for training and delivering TB information and education to health professionals and others have been inadequate. Objective:

Develop an integrated system for professional information and communication on TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Educate policymakers, CBOs, and the        NCET           Ongoing
    public about MDR-TB.
 2. Develop and pilot electronic "one-stop     CDC             1992
    shopping" for TB information and
 3. Develop and pilot a responsive infor-      CDC             1993
    mation network for public health
    officials that provides timely elec-
    tronic data and information for action.
 4. Develop a communication strategy for       CDC             1993
    TB information that will reach the         NCET
    public, health-care providers, and
    high-risk populations.
 5. Develop templates and models for           CDC              1993
    health departments to develop             ASTHO
    relevant media-based information          USCLHO
    campaigns.                                NACHO
 6. Consider creating a CDC TB hotline.        CDC             1992
 7. Evaluate effectiveness of training         CDC             1993
    and education efforts.                     NCET


Perform research to identify better methods for combatting MDR-TB.

Many important questions about the biology of TB remain unanswered. However, for many years, research efforts and funding have not been focused on TB, and few researchers pursued careers in this area. As a result, such areas as the microbiology of the organism, vaccines, and treatment methods warrant immediate and extensive research. This need is highlighted by the concurrence of TB with HIV infection and the drug resistance of the organism.

Problem 31

Research on TB needs to be conducted and promoted by a variety of agencies, including CDC, NIH, FDA, and others. Coordination of research efforts among these agencies will be important in ensuring that critical knowledge gaps are addressed effectively. Objective:

Develop a mechanism for coordinating TB research activities among the various agencies involved.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Form a research subcommittee to       National MDR-TB    Under way
    ensure interagency coordination of      Task Force
    research programs.

Problem 32

There is a critical lack of knowledge about the basic characteristics of M. tuberculosis (e.g., growth, physiology, biochemistry, genetics, and molecular biology). This knowledge gap is a barrier to the development of new treatment and control modalities. Objective:

Provide increased support for basic research on the biology of M. tuberculosis and the host responses to infection.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Determine the basic mechanisms of          NIH            Ongoing
    acquisition of drug resistance in M.       CDC
    tuberculosis infection.
 2. Expand basic research on the physiol-      NIH            Ongoing
    ogy, biochemistry, and structural          CDC
    biology of M. tuberculosis virulence
    factors and pathogenic mechanisms.
 3. Determine the mechanisms of immuno-        NIH            Ongoing
    pathogenesis of M. tuberculosis            CDC
    infection, with special emphasis on
    the role of cytokines in disease
 4. Determine the immunologic and bio-         NIH            Ongoing
    logic factors associated with or           CDC
    responsible for latency and reacti-
    vation of M. tuberculosis infection.
 5. Develop animal model systems to sup-       NIH            Ongoing
    port basic and applied research on         CDC
    M. tuberculosis.
 6. Provide purified preparations of TB        NIH             1992
    bacilli, purified antigens, and other      CDC
    purified components from M. tuber-
    culosis to facilitate research.

Problem 33

Existing diagnostic methods to identify persons with drug-resistant TB are very slow, impeding treatment and control efforts.

Develop and evaluate new technology to rapidly and reliably diagnose cases of TB and identify patterns of drug susceptibility.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop and evaluate rapid and simple      CDC            1992-93
    methods for subtyping M. tuberculosis      NIH
    and identifying drug-resistant strains.
 2. Facilitate the development of improved     NIH             1992
    diagnostic kits by systematically          CDC
    characterizing existing monoclonal         FDA
    antibodies against M. tuberculosis to
    determine the specificity and cross-
    reactivity of mycobacterial antigens.
 3. Develop and assess new methods for         CDC            Ongoing
    rapidly evaluating the susceptibility      FDA
    of tubercle bacilli in clinical            NIH
    isolates to antituberculosis drugs.
 4. Develop and evaluate antigen detection     NIH            Ongoing
    assays and indirect serologic assays       CDC
    for rapid diagnosis of active TB that      FDA
    can be used in populations with either
    compromised or intact immune systems.
 5. Evaluate the specificity and sensitivity   CDC             1993
    of candidate direct and indirect assays    NIH
    for rapid diagnosis and identification
    of resistant strains in field situations.
 6. Redirect a portion of the existing Small   NIH             1992
    Business Innovation Research (SBIR)
    program to encourage development of
    better tests.
 7. Publish program announcements to en-       NIH             1993
    courage investigator-initiated (RO1)
    grant applications through NIH.
 8. Implement an extramural research pro-      CDC             1993
    gram targeted toward development of        HRSA
    diagnostic tests, rapid detection of
    drug resistance, and evaluation of
    candidate drugs.

Problem 34

Existing methods for identifying latent TB infection, especially among persons who are immunosuppressed, lack sensitivity and specificity.

Develop and evaluate new technologies to rapidly and reliably identify latent tuberculous infection among both immunocompetent and immunosuppressed persons.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop and evaluate antigen detection     CDC            1993-95
    assays and indirect serologic assays       NIH
    for rapid diagnosis of latent TB
    infection that can be used in popula-
    tions with either compromised or intact
    immune systems.
 2. Determine sensitivity of different         CDC            1993-95
    diagnostic tests for TB for HIV-           NIH
    infected patients at different levels
    of immune function.
 3. Redirect a portion of the existing         NIH             1992
    SBIR program to encourage development
    of better tests.
 4. Publish program announcements to en-       NIH             1993
    courage RO1 grant applications.

Problem 35

Currently available drugs are not sufficiently effective in treating MDR-TB. The duration of therapy required to treat TB with currently available drugs leads to noncompliance with therapy and development of drug-resistant disease.

Encourage the development and evaluation of new drugs and modalities to treat and prevent MDR-TB, as well as to reduce the duration of therapy required to cure drug-susceptible TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Implement a protocol for a human trial     CDC            Ongoing
    of preventive therapy of MDR-TB with
 2. Initiate in vivo evaluation of quino-      CDC             1992
    lones.                                     NIH
 3. Evaluate depot preparations for            CDC             1992
    antituberculous chemotherapy.              NIH
 4. Establish clinical trials to evaluate      NIH             1992
    the potential antituberculosis effects     CDC
    of drugs that have already been            FDA
    approved for other indications.
 5. Continue cooperative agreements with       CDC            Ongoing
    pharmaceutical manufacturers to
    screen compounds for antituberculosis
 6. Encourage pharmaceutical manufac-          FDA            Ongoing
    turers and academic researchers to         NIH
    develop and screen new compounds for       CDC
    antituberculosis activity.                 HRSA
 7. Adapt new procedures for rapid, large-     CDC            Ongoing
    scale in vitro screening of potential      HRSA
    antituberculous drugs.
 8. Develop ability to test the in vivo        CDC            Ongoing
    antituberculosis activity in animal        NIH
    models of experimental compounds found     HRSA
    to be active in the rapid in vitro
 9. Design and evaluate clinical trials        CDC            Ongoing
    of TB treatment regimens by using new      NIH
    compounds and modalities (including        FDA
    depot preparations).                       HRSA
10. Design and evaluate clinical trials        CDC            Ongoing
    of TB preventive therapy regimens          NIH
    that involve new compounds.                FDA
11. Expand existing National Cooperative       NIH            Ongoing
    Drug Discovery Group-Opportunistic         HRSA
    Infections Program.
12. Initiate new research to establish         NIH            Ongoing
    drug screening capability and develop      CDC
    animal models.                             HRSA
13. Expand existing AIDS clinical research     NIH             1993
    efforts, including the AIDS Clinical
    Trials Group, CPCRA, and the Division
    of AIDS Treatment Research Initiative.
14. Fund meritorious grant proposals           NIH            1992-93
    received in response to RFAs for the
    development of new antituberculosis
15. Evaluate the effect of therapy on the      NIH             1993
    infectiousness of TB patients to           CDC
    determine the interval between the
    initiation of treatment and loss of

Problem 36

Currently available vaccines against TB are not reliably effective in preventing acquisition of TB.

Develop and evaluate new and improved vaccines to prevent infection and disease with M. tuberculosis.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Issue an RFA to address the following      NIH             1992
    objectives: identify and characterize
    immunogenic components of M. tuber-
    culosis; determine which immunogens
    elicit protective responses; charac-
    terize protective host responses;
    and develop animal models.
 2. Evaluate candidate vaccines in phase       NIH            1994-98
    I, II, and III clinical trials.            CDC

Problem 37

The efficacy of various technologies for preventing TB transmission (e.g., general and local ventilation, UVGI, and personal protective equipment) has not been adequately evaluated.

Conduct basic and applied research on the efficacy and role of various control methods for preventing transmission of TB.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Conduct research to develop and evalu-     CDC             1993
    ate the efficacy of various elements
    of ventilation (e.g., negative
    pressure, high-efficiency particulate
    air {HEPA} filters, laminar flow,
    UVGI, in-room HEPA filtration units)
    and to identify air disinfection
    techniques that do not require major
    facility modifications.
 2. Design sampling and analytic methods       CDC             1993
    for measuring environmental contami-
    nation with TB bacilli.
 3. Evaluate the efficacy of respiratory       CDC             1993
    protective devices against bioaer-
    osols, including particulate filter
    penetration, size characterization of
    droplet nuclei, and determination of
    respirator performance characteristics.
 4. Fund extramural research to evaluate       CDC             1992
    the efficacy of UVGI, mycobacterial
    killing kinetics (including consider-
    ations of in-room aerosol distribution,
    effects of room air circulation, and
    interactions with ventilation and
 5. Study the efficacy of the enclosed         CDC             1993
    floor model UVGI-fan unit.

Problem 38

Poor patient compliance leads to development of MDR-TB. Compliance is influenced by patient characteristics; characteristics of the health-care environment, including operational factors and compliance-enhancing intervention; and communication between patient and providers, including the quality of interpersonal communication and use of educational materials for transfer of information about the nature of the disease and treatment.

Identify ways to improve compliance with therapy through behavioral research.

                                           Responsible         Start
Implementation steps                       organization        date
 1. Develop and test a predictor instru-       CDC            1992-95
    ment to identify the patient factors      ADAMHA
    associated with poor compliance and
    development of MDR-TB, including
    personal, social, and cultural factors.
 2. Expand research on cultural influences     CDC            1992-96
    on health-care utilization and adher-     ADAMHA
    ence among foreign-born persons and
    minority groups at risk for MDR-TB.
 3. Design and conduct operational             CDC            1993-98
    research on characteristics of TB         ADAMHA
    health services, including case
    management, data management, staff
    selection and training, staff incen-
    tives, physician training, management
    and organizational structure, rela-
    tionships with community, community
    perceptions of services, community
    resistance to public health services,
    and clinic policies and practices.
 4. Evaluate effectiveness of various          CDC            1993-97
    adherence interventions, including        ADAMHA
    incentives, supports (enablers), and
    provision of social and additional
    health-care services to patients
    through TB programs.
 5. Conduct a study of communication           CDC            1993-96
    styles of TB health-care providers;       ADAMHA
    identify strengths and weaknesses and
    calculate the relationship between
    various styles and treatment outcomes.
 6. By using research outcomes, develop        CDC            1996-99
    and evaluate innovative methods for       ADAMHA
    training health-care providers in
    effective communication styles with
 7. Survey TB treatment practices of           CDC            1993-94
    health-care providers to determine        ADAMHA
    discrepancies in practices that may
    lead to poor compliance and develop-
    ment of MDR-TB.
 8. Utilize data from the survey of TB         CDC            1992-95
    treatment practices of health-care        ADAMHA
    providers to design an in-depth
    study of barriers among providers
    most likely to treat patients at risk
    for MDR-TB.
 9. Conduct formative communications           CDC            1994-97
    research to identify innovative and       ADAMHA
    effective strategies to use persuasive
    educational messages to reach popula-
    tions with high disease prevalence.
10. Evaluate educational strategies for        CDC            1995-97
    targeting the health-care providers       ADAMHA
    of patients at risk for MDR-TB.


This National Action Plan to Combat Multidrug-Resistant Tuberculosis lays out a series of activities that need to be undertaken at the national level. Priorities will vary from agency to agency, and activities should be undertaken within the time frames indicated, as resources permit. Many activities that are indicated as starting in 1992 and 1993 will continue in subsequent years. For state and local health agencies, the highest priority remains the detection and effective treatment of active cases. The Plan is a blueprint for action by federal agencies. However, many of the implementation steps will depend on the cooperation of many sectors of society. Indeed, the success of the plan will depend on a concerted effort and commitment at all levels and will involve collaboration between public health and other government agencies, professional societies, voluntary agencies, health-care providers, and many others.

Today the United States is at a critical point in history with respect to TB. Although a number of factors, including MDR-TB, are having an adverse effect on the TB problem, TB can be controlled and eventually eliminated if aggressive action is taken immediately. If such action is not taken, the TB problem will continue to grow in size and in complexity, and the costs of containing it will escalate.

* The term "alien" is defined in the U.S. Immigration and Nationality Act as any person not a citizen or national of the United States.


  1. CDC. Nosocomial transmission of multidrug-resistant TB to health-care workers and HIV-infected patients in an urban hospital -- Florida. MMWR 1990;39:718-22.
  2. CDC. Nosocomial transmission of multidrug-resistant tuberculosis among HIV-infected persons -- Florida and New York, 1988-1991. MMWR 1991;40:585-91.
  3. Dooley SW, Castro KG, Hutton MD, Mullan RJ, Polder JA, Snider DE Jr. Guidelines for preventing the transmission of tuberculosis in health-care settings, with special focus on HIV-related issues. MMWR 1990;39(No. RR-17).
  4. CDC. Purified protein derivative (PPD)-tuberculin anergy and HIV infection: guidelines for anergy testing and management of anergic persons at risk of tuberculosis. MMWR 1991;40(No. RR-5):27-33.


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