Insights in Public Health Eliminating Tuberculosis in Hawai‘i: Yesterday, Today, and Tomorrow Richard Brostrom MD-MSPH and Glenn Wasserman MD, MPH Insights in Public Health is a monthly solicited column from the public health community and is coordinated by HJMPH Contributing Editors Tetine L. Sentell PhD from the Office of Public Health Studies at the University of Hawai‘i at Manoa and Donald Hayes MD, MPH from the Hawai‘i Department of Health in collaboration with HJMPH Associate Editors Ranjani R. Starr MPH and Lance K. Ching PhD, MPH from the Hawai‘i Department of Health.
Introduction The Hawai‘i Department of Health has actively engaged in tuberculosis (TB) control for more than 100 years. During that time, Hawai‘i has witnessed a remarkable decline in TB morbidity and mortality. New diagnostic tests and changing TB epidemiology warrant a change in our current approach to TB control. Currently, TB is a reportable condition under Hawai‘i Administrative Rules (HAR), Title 11, Chapter 156. Updated HAR for TB screening are nearly complete and reflect best practices and priorities for TB control. These changes include use of a TB Risk Assessment Screening Questionnaire, a new State TB Clearance Form, and inclusion of interferon gamma release assay (IGRA) blood tests to identify individuals with TB infection.1 These improvements will affect the medical community and others who partner with the State of Hawai‘i Department of Health to provide quality TB screening. What is TB? TB is a disease caused by a bacterium called Mycobacterium tuberculosis. The bacteria often attack the lungs, but TB bacteria can attack any part of the body. TB disease is curable, but treatment is difficult, and requires a minimum of six months of adherence to achieve remission. TB is spread through the air from one person to another, and exists in two major forms, latent TB infection and TB disease. People with latent TB infection are not symptomatic nor infectious, but they represent an unfortunate reservoir of future TB disease. Nearly one-third of the world’s population (over 2 billion people) have latent TB infection. Many people in the United States and around the world still suffer from TB disease. With over 9 million new TB cases in 2014, and 1.5 million TB deaths, TB is the leading infectious disease killer worldwide.2 TB in Hawai‘i: Yesterday With 136 new TB cases in 2014, Hawai‘i has the highest state TB rate in the United States (9.6 cases per 100,000 residents).1 Despite this distinction, the State of Hawai‘i Department of Health has achieved remarkable success controlling TB disease in our community. By the early 1900s, despite outbreaks of cholera and the “specter of leprosy,” it was actually TB that constituted
the number one public health problem in the new territory.3 In 1900, one out of every 200 people living in Honolulu died from TB (486 deaths per 100,000 population), a rate that was 2,500 times higher than in 2015 (0.2/100,000).4 Beginning with Leahi Hospital in 1901, special tuberculosis hospitals were constructed to manage the overwhelming number of TB patients on O‘ahu, Maui, Hawai‘i Island, and Kaua‘i. Only crude surgical treatment for pulmonary tuberculosis was available. The dramatic reduction in cases and deaths was mostly due to isolation of TB patients and removal of infectious individuals from their households and the general community. By the 1930s, the rate of TB in Hawai‘i had fallen to less than half its prior levels.4 Still, in 1935, with improved reporting and a growing number of hospital beds for TB cases, 2,995 active tuberculosis cases were officially recorded by the Territorial Health Board.4 Hundreds more outpatient TB cases were never officially reported, and hundreds more died of TB without autopsy or a diagnosis. Effective medical treatment for TB began in Hawai‘i in 1948, when physicians began to use streptomycin alone, and then in combination with para-amino salicylic acid. By 1950, the Health Department listed more than 1,200 tuberculosis beds in the Hawaiian Islands.6 It was not enough. Despite the relatively large inpatient capacity for TB patients, many patients had to wait years before they could be hospitalized and treated with TB medications. Despite the lack of an effective vaccine, rates of active TB were reduced in Hawai‘i by a remarkable 99% between 1935 and 2014. The change in local TB rates brought equally remarkable shifts in TB clinical presentation and epidemiology. In the 1930s, TB was predominantly a disease of Native Hawaiians and Japanese people, while today TB affects mostly Filipinos and neighboring Pacific Islanders. Figure 1 depicts the changing pattern of ethnicity for the Hawai‘i TB Control Program. TB in Hawai‘i: Today The Lanakila TB Clinic manages approximately 90% of Hawai‘i’s TB cases, providing quality direct patient care from diagnosis to cure. TB treatment is still far from routine, however. Newer cases are often more complex and difficult to
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 117
Figure 1: Reported Primary Ethnicity for TB Patients in Hawai‘i (1920 – 2009) *Data taken from a sample of 250 historical records
Figure 2. Countries of Birth for all Persons with Reported with TB, Hawai‘i, 2014 *Other countries include: American Samoa (1), Indonesia (1), Kiribata (1), Korea (2), Malaysia (1), Ukraine (1)
treat. Recent drug resistant TB strains require longer treatment times with complex medical regimens. These regimens have serious side effects affecting compliance and tolerability, and the course of treatment often reaches two years. TB Disease in Hawai‘i: For more than 90% of TB cases in Hawai‘i, TB disease stems from previous exposures in other countries where TB is endemic (Figure 2). In 2014, nearly 60% of Hawai‘i TB cases were among people born in the Philippines, and the majority of those cases occurred in people who emigrated from the Philippines and developed TB disease many years after coming to Hawai‘i. Between 10 to 20% of cases in Hawai‘i each year occur among Pacific Islanders who travel to Hawai‘i under the Compact of Free Association. TB has always been a disease that is closely associated with social determinants of health. Social determinants of health are life-enhancing resources, such as food supply, housing, economic and social relationships, transportation, education, and health care, whose unequal distribution across populations effectively determines length and quality of life. In most of our patients with active TB, cultural differences, educational attainment, access to health care, housing, mental health, substance use, and occasionally homelessness can be major factors in identifying and managing cases. Managing significant cultural and economic gaps has always been an essential element of TB control in Hawai‘i. Co-prevalent Diseases: Additionally, as the average age of TB cases continues to increase, the program manages more TB cases with concurrent chronic diseases, polypharmacy, and complex medication interactions. In 2014, for example, 40% of Hawai‘i’s adult TB cases had concurrent diabetes. Hawai‘i
has been spared the epidemic of TB co-infection with human immunodeficiency virus (HIV) seen nationally and worldwide, having one or two cases annually. TB Treatment: Most TB patients begin to improve within a week of treatment, but to achieve a cure and prevent TB recurrence, medications are required for a minimum of 6 months. To combat the long treatment periods, the State TB Control Program uses “directly observed therapy—short course” (DOT). Hawai‘i TB Control Program staff visits each patient daily to deliver treatment in-person. At the same time, the healthcare worker assesses each patient for symptoms of TB recurrence, discusses and observes each patient for the presence of medication side effects, and helps to identify others in the household who may have been exposed. To some, this system may seem resource intensive, but DOTs remains the national and global standard for successfully treating TB in any community. Contact Investigation: Rapid identification and treatment of infectious TB cases remains the most ideal way for TB programs to reduce exposure in the community. In addition to treating patients, the TB Control Program provides “contact tracing” to identify exposed family and community members and offer medications to prevent development of TB disease. For households and workplaces of contagious TB patients, Hawai‘i’s public health nurses evaluate more than 600 exposed individuals each year. Routine TB Screening: Hawai‘i Administrative Rules currently mandate one-time screening for school children, college students, food handlers, immigrants, annual screening for healthcare workers, and people living in long term care facilities licensed
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 118
Table 1. Results of TB Screening in Hawai‘i 2010 to 2014: Foreign Born and US Born Foreign Born 2010-2014 HAR Category
US Born 2010-2014
TST’s Placed and Read
Active TB Cases
TB Cases per 100,000
TST’s Placed and Read
Active TB Cases
TB Cases per 100,000
Care home operator
1485
3
202
2638
0
0
Care home resident
1436
0
0
7241
0
0
Food handler
4985
6
120
12042
1
8
School employee
1631
2
123
9588
0
0
Student
7989
14
175
24440
0
0
Health care worker
5815
2
34
18439
0
0
Total
23341
27
116
74388
1
1
HAR = Hawai‘i Administrative Rules; TST = tuberculin skin test; TB = tuberculosis
by the state. The Hawai‘i TB Control Branch, working with the Public Health Nursing Branch, places tuberculin skin tests (TSTs) for nearly 50,000 individuals every year to provide screening for TB. Many thousands more are screened by the private sector. Additional TB screening is performed at Lanakila Health Clinic for people seeking temporary placement in homeless and crisis shelters, as well as for people entering prison in Hawai‘i. State-mandated TB testing has been an effective way to find active TB cases among Hawai‘i’s foreign-born populations. However, the majority of TB testing among US-born individuals is significantly less effective in finding cases of TB disease. Table 1 lists the results of TB screening activities in the five-year period between 2010 and 2014. The table shows an approximately one hundred-fold greater risk of TB disease identified by TB screening among individuals who are born outside the United States, and highlights the importance of screening based upon country of birth. Instead of mandated TB testing for low risk individuals, TB control efforts will have a greater impact if these resources are focused on treating individuals with latent TB infection who are at greatest risk for developing active disease. In Hawai‘i, that target population includes people with recent prolonged exposure to someone with infectious TB, individuals arriving from high-risk countries with a positive TB test, or individuals with medical problems that increase the risk of progression from TB infection to TB disease. TB in Hawai‘i: Tomorrow The State of Hawai‘i TB Control Branch has proposed new rules to effectively target individuals at the highest risk for latent TB infection. The proposed rules are based on screening recommendations by the American Academy of Pediatrics,5 the American Thoracic Society, and the US Centers for Disease Control and Prevention.7 These rules allow clinicians to more effectively test individuals based on TB risk status, in turn enabling the TB Control Program to more efficiently focus TB preventive treatment on high-risk individuals with latent TB infection. TB screening will remain an important part of TB Control in Hawai‘i.
State of Hawai‘i TB Risk Assessment: With the proposed new TB rules, nearly all of the individuals who required TB screening in the past will still require TB screening. However, the mechanics of TB screening will be adapted to reflect the changing epidemiology of TB in the state. Currently, Hawai‘i Administrative Rules require placing a TST on clients as a requirement for work or school without regard to the pre-test risk of latent TB infection. In the 1960s, the TST replaced the chest X-ray as the primary method for TB screening. With greater understanding of the epidemiological basis for TB transmission, the TB risk assessment process will no longer use the TST as the preferred method for initial screening for TB infection and disease. Under the proposed changes, residents seeking a TB clearance (including school children and food handlers) will be directed to take the State of Hawai‘i TB Risk Assessment. The State of Hawai‘i TB Risk Assessment is a standardized list of peerreviewed questions designed to provide a rapid assessment for the risk of TB exposure or TB disease among individuals. The State of Hawai‘i TB Risk Assessment is not a clinical test, but helps to increase the likelihood for a true positive TST or other test for TB infection. In this way, the TB Program will reduce the number of low-risk individuals being tested who are also at risk for false-positive TB test results, minimize the risk for significant side-effects of preventive treatment, and focus on completing preventive treatment for our high-risk populations. If the State of Hawai‘i TB Risk Assessment responses are negative (indicating low risk for TB exposure or TB disease progression), then asymptomatic individuals will not be required to undergo an actual test for TB infection. Instead, the provider may issue a TB clearance without administering a TST or other test for TB infection. For individuals meeting any of the high-risk criteria, and for all healthcare workers, an actual test for TB infection will still be required. With the new rules, any person born in a high-risk country where TB is poorly controlled will still require testing for TB infection. Other major risk factors for TB infection included in the State of Hawai‘i TB Risk Assessment include identifying children with foreign-born parents, individuals with a known exposure to active TB, or individuals with a prior history of a positive TB test. A copy of the draft State of Hawai‘i TB Risk
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 119
Assessment (with instructions and guidance for interpreting results) will soon be distributed to providers and institutions performing TB testing across the state. Some medical conditions may impart a smaller impact on the incidence of TB infection, but have been shown to dramatically increase the risk of progression to active TB, and therefore warrant a TB test. These risk factors include immunosuppression from various diseases (eg, HIV, end-stage renal disease) or medications (eg, prolonged use of corticosteroids, anti-tumor necrosis factor alpha medications, or immunosuppressive drugs used for organ transplantation). These conditions are included in the State of Hawai‘i TB Risk Assessment to aid the clinician in a decision to test for TB infection. After many years of routine TST testing in Hawai‘i, incorporating a risk-based approach to TB testing is a significant paradigm change that will be challenging to implement. The TB Control Branch estimates that 30% - 40% of all TB tests currently administered in Hawai‘i will no longer be required with the proposed TB screening rules. Clinicians can still obtain a TB test at their own discretion despite a negative initial TB screen, but the TB test will no longer be required by the State of Hawai‘i. New State TB Clearance Forms: In the past, if the TB screening test was negative, a TB clearance was provided to the individual who was tested. As required by the Hawai‘i Administrative Rules, the forms included TB test results. These TB test results were provided to the school registrar or the employer, who would often verify that an individual was properly cleared by the clinician. In order to provide greater protection of personal medical information, a new standardized State TB Clearance form has been created to be used by clinicians in the State. The new form will not include TB test results. Employers and school registrars will no longer be required to verify the TB screening results. New State TB Blood Tests: For individuals who require statemandated TB screening, current Hawai‘i Administrative Rules only allow for the TST as a test for TB screening. Other tests were not developed and sufficiently tested when these rules were developed. With its first use in 1918, the TST is often referred to as the oldest medical test still performed today. The TST is relatively inexpensive to administer (approximately $5 per test),
but requires a second visit 48 to 72 hours later and may have false positive results in younger foreign-born individuals who received Bacille Calmette–Guèrin (BCG) vaccine. Newer IGRA blood tests (QFT-gold®, T-Spot®) measure TB infection with greater specificity than the TST. With the proposed new rules, all CDC-approved, FDA-certified tests for TB infection will be accepted by the TB Program. Until the high cost of IGRA tests are significantly reduced, the TST will likely continue to be the primary testing methodology for many programs. At the present time, IGRA tests for TB infection are not recommended for children under age 5.7 Summary Working with Hawai‘i’s medical community, the State of Hawai‘i Department of Health TB Control Branch has reduced the rate of TB disease by 99% in the past 80 years. Despite this remarkable achievement, Hawai‘i TB rates continue to be among the highest in the United States, and TB control remains a public health priority for the State. In keeping with more recent screening recommendations, the TB Control Branch is changing our focus to test and prevent TB among individuals with the highest TB risk. Although the proposed new rules may require a significant adjustment for the Hawai‘i TB Control Branch and our partners in the medical community, these changes are needed to help us move forward in our shared goal to further reduce the morbidity and mortality of TB in our State. Authors’ Affiliations: - Communicable Disease and Public Health Nursing Division, State of Hawai‘i Department of Health, Honolulu, HI; and Centers for Disease Control and Prevention, Division of TB Elimination, Atlanta, GA (RB) - Communicable Disease and Public Health Nursing Division, State of Hawai‘i Department of Health, Honolulu, HI (GW) References
1. CDC. Reported tuberculosis in the United States, 2013. Atlanta, GA: US Department of Health and Human Services, CDC; 2014. 2. WHO Global TB Report 2015, accessed at http://www.who.int/tb/publications/global_report/ gtbr2015_executive_summary.pdf?ua=1. 3. CDC. Updated guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection—United States, 2010. MMWR. 2010;59(No. RR-5). 4. Annual Report of the Governor of Hawaii to the Secretary of the Interior for the Fiscal Year ended June 30, 1935. US Govt Printing Office, Washington DC, 1935. 5. American Academy of Pediatrics, Committee on Infectious Diseases (1994) Screening for tuberculosis in infants and children. Pediatrics. 93:131–134. 6. Miles JA. Public Health Progress in the Pacific: Geographical Background and Regional Development, Kluwer Academic Publishers Group, 1964. 7. CDC. Treatment of tuberculosis. MMWR. 2003;52(No. RR-11). 4. CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR. 2000;49(No. RR-6).
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 120
Introduction The Hawai‘i Department of Health has actively engaged in tuberculosis (TB) control for more than 100 years. During that time, Hawai‘i has witnessed a remarkable decline in TB morbidity and mortality. New diagnostic tests and changing TB epidemiology warrant a change in our current approach to TB control. Currently, TB is a reportable condition under Hawai‘i Administrative Rules (HAR), Title 11, Chapter 156. Updated HAR for TB screening are nearly complete and reflect best practices and priorities for TB control. These changes include use of a TB Risk Assessment Screening Questionnaire, a new State TB Clearance Form, and inclusion of interferon gamma release assay (IGRA) blood tests to identify individuals with TB infection.1 These improvements will affect the medical community and others who partner with the State of Hawai‘i Department of Health to provide quality TB screening. What is TB? TB is a disease caused by a bacterium called Mycobacterium tuberculosis. The bacteria often attack the lungs, but TB bacteria can attack any part of the body. TB disease is curable, but treatment is difficult, and requires a minimum of six months of adherence to achieve remission. TB is spread through the air from one person to another, and exists in two major forms, latent TB infection and TB disease. People with latent TB infection are not symptomatic nor infectious, but they represent an unfortunate reservoir of future TB disease. Nearly one-third of the world’s population (over 2 billion people) have latent TB infection. Many people in the United States and around the world still suffer from TB disease. With over 9 million new TB cases in 2014, and 1.5 million TB deaths, TB is the leading infectious disease killer worldwide.2 TB in Hawai‘i: Yesterday With 136 new TB cases in 2014, Hawai‘i has the highest state TB rate in the United States (9.6 cases per 100,000 residents).1 Despite this distinction, the State of Hawai‘i Department of Health has achieved remarkable success controlling TB disease in our community. By the early 1900s, despite outbreaks of cholera and the “specter of leprosy,” it was actually TB that constituted
the number one public health problem in the new territory.3 In 1900, one out of every 200 people living in Honolulu died from TB (486 deaths per 100,000 population), a rate that was 2,500 times higher than in 2015 (0.2/100,000).4 Beginning with Leahi Hospital in 1901, special tuberculosis hospitals were constructed to manage the overwhelming number of TB patients on O‘ahu, Maui, Hawai‘i Island, and Kaua‘i. Only crude surgical treatment for pulmonary tuberculosis was available. The dramatic reduction in cases and deaths was mostly due to isolation of TB patients and removal of infectious individuals from their households and the general community. By the 1930s, the rate of TB in Hawai‘i had fallen to less than half its prior levels.4 Still, in 1935, with improved reporting and a growing number of hospital beds for TB cases, 2,995 active tuberculosis cases were officially recorded by the Territorial Health Board.4 Hundreds more outpatient TB cases were never officially reported, and hundreds more died of TB without autopsy or a diagnosis. Effective medical treatment for TB began in Hawai‘i in 1948, when physicians began to use streptomycin alone, and then in combination with para-amino salicylic acid. By 1950, the Health Department listed more than 1,200 tuberculosis beds in the Hawaiian Islands.6 It was not enough. Despite the relatively large inpatient capacity for TB patients, many patients had to wait years before they could be hospitalized and treated with TB medications. Despite the lack of an effective vaccine, rates of active TB were reduced in Hawai‘i by a remarkable 99% between 1935 and 2014. The change in local TB rates brought equally remarkable shifts in TB clinical presentation and epidemiology. In the 1930s, TB was predominantly a disease of Native Hawaiians and Japanese people, while today TB affects mostly Filipinos and neighboring Pacific Islanders. Figure 1 depicts the changing pattern of ethnicity for the Hawai‘i TB Control Program. TB in Hawai‘i: Today The Lanakila TB Clinic manages approximately 90% of Hawai‘i’s TB cases, providing quality direct patient care from diagnosis to cure. TB treatment is still far from routine, however. Newer cases are often more complex and difficult to
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 117
Figure 1: Reported Primary Ethnicity for TB Patients in Hawai‘i (1920 – 2009) *Data taken from a sample of 250 historical records
Figure 2. Countries of Birth for all Persons with Reported with TB, Hawai‘i, 2014 *Other countries include: American Samoa (1), Indonesia (1), Kiribata (1), Korea (2), Malaysia (1), Ukraine (1)
treat. Recent drug resistant TB strains require longer treatment times with complex medical regimens. These regimens have serious side effects affecting compliance and tolerability, and the course of treatment often reaches two years. TB Disease in Hawai‘i: For more than 90% of TB cases in Hawai‘i, TB disease stems from previous exposures in other countries where TB is endemic (Figure 2). In 2014, nearly 60% of Hawai‘i TB cases were among people born in the Philippines, and the majority of those cases occurred in people who emigrated from the Philippines and developed TB disease many years after coming to Hawai‘i. Between 10 to 20% of cases in Hawai‘i each year occur among Pacific Islanders who travel to Hawai‘i under the Compact of Free Association. TB has always been a disease that is closely associated with social determinants of health. Social determinants of health are life-enhancing resources, such as food supply, housing, economic and social relationships, transportation, education, and health care, whose unequal distribution across populations effectively determines length and quality of life. In most of our patients with active TB, cultural differences, educational attainment, access to health care, housing, mental health, substance use, and occasionally homelessness can be major factors in identifying and managing cases. Managing significant cultural and economic gaps has always been an essential element of TB control in Hawai‘i. Co-prevalent Diseases: Additionally, as the average age of TB cases continues to increase, the program manages more TB cases with concurrent chronic diseases, polypharmacy, and complex medication interactions. In 2014, for example, 40% of Hawai‘i’s adult TB cases had concurrent diabetes. Hawai‘i
has been spared the epidemic of TB co-infection with human immunodeficiency virus (HIV) seen nationally and worldwide, having one or two cases annually. TB Treatment: Most TB patients begin to improve within a week of treatment, but to achieve a cure and prevent TB recurrence, medications are required for a minimum of 6 months. To combat the long treatment periods, the State TB Control Program uses “directly observed therapy—short course” (DOT). Hawai‘i TB Control Program staff visits each patient daily to deliver treatment in-person. At the same time, the healthcare worker assesses each patient for symptoms of TB recurrence, discusses and observes each patient for the presence of medication side effects, and helps to identify others in the household who may have been exposed. To some, this system may seem resource intensive, but DOTs remains the national and global standard for successfully treating TB in any community. Contact Investigation: Rapid identification and treatment of infectious TB cases remains the most ideal way for TB programs to reduce exposure in the community. In addition to treating patients, the TB Control Program provides “contact tracing” to identify exposed family and community members and offer medications to prevent development of TB disease. For households and workplaces of contagious TB patients, Hawai‘i’s public health nurses evaluate more than 600 exposed individuals each year. Routine TB Screening: Hawai‘i Administrative Rules currently mandate one-time screening for school children, college students, food handlers, immigrants, annual screening for healthcare workers, and people living in long term care facilities licensed
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 118
Table 1. Results of TB Screening in Hawai‘i 2010 to 2014: Foreign Born and US Born Foreign Born 2010-2014 HAR Category
US Born 2010-2014
TST’s Placed and Read
Active TB Cases
TB Cases per 100,000
TST’s Placed and Read
Active TB Cases
TB Cases per 100,000
Care home operator
1485
3
202
2638
0
0
Care home resident
1436
0
0
7241
0
0
Food handler
4985
6
120
12042
1
8
School employee
1631
2
123
9588
0
0
Student
7989
14
175
24440
0
0
Health care worker
5815
2
34
18439
0
0
Total
23341
27
116
74388
1
1
HAR = Hawai‘i Administrative Rules; TST = tuberculin skin test; TB = tuberculosis
by the state. The Hawai‘i TB Control Branch, working with the Public Health Nursing Branch, places tuberculin skin tests (TSTs) for nearly 50,000 individuals every year to provide screening for TB. Many thousands more are screened by the private sector. Additional TB screening is performed at Lanakila Health Clinic for people seeking temporary placement in homeless and crisis shelters, as well as for people entering prison in Hawai‘i. State-mandated TB testing has been an effective way to find active TB cases among Hawai‘i’s foreign-born populations. However, the majority of TB testing among US-born individuals is significantly less effective in finding cases of TB disease. Table 1 lists the results of TB screening activities in the five-year period between 2010 and 2014. The table shows an approximately one hundred-fold greater risk of TB disease identified by TB screening among individuals who are born outside the United States, and highlights the importance of screening based upon country of birth. Instead of mandated TB testing for low risk individuals, TB control efforts will have a greater impact if these resources are focused on treating individuals with latent TB infection who are at greatest risk for developing active disease. In Hawai‘i, that target population includes people with recent prolonged exposure to someone with infectious TB, individuals arriving from high-risk countries with a positive TB test, or individuals with medical problems that increase the risk of progression from TB infection to TB disease. TB in Hawai‘i: Tomorrow The State of Hawai‘i TB Control Branch has proposed new rules to effectively target individuals at the highest risk for latent TB infection. The proposed rules are based on screening recommendations by the American Academy of Pediatrics,5 the American Thoracic Society, and the US Centers for Disease Control and Prevention.7 These rules allow clinicians to more effectively test individuals based on TB risk status, in turn enabling the TB Control Program to more efficiently focus TB preventive treatment on high-risk individuals with latent TB infection. TB screening will remain an important part of TB Control in Hawai‘i.
State of Hawai‘i TB Risk Assessment: With the proposed new TB rules, nearly all of the individuals who required TB screening in the past will still require TB screening. However, the mechanics of TB screening will be adapted to reflect the changing epidemiology of TB in the state. Currently, Hawai‘i Administrative Rules require placing a TST on clients as a requirement for work or school without regard to the pre-test risk of latent TB infection. In the 1960s, the TST replaced the chest X-ray as the primary method for TB screening. With greater understanding of the epidemiological basis for TB transmission, the TB risk assessment process will no longer use the TST as the preferred method for initial screening for TB infection and disease. Under the proposed changes, residents seeking a TB clearance (including school children and food handlers) will be directed to take the State of Hawai‘i TB Risk Assessment. The State of Hawai‘i TB Risk Assessment is a standardized list of peerreviewed questions designed to provide a rapid assessment for the risk of TB exposure or TB disease among individuals. The State of Hawai‘i TB Risk Assessment is not a clinical test, but helps to increase the likelihood for a true positive TST or other test for TB infection. In this way, the TB Program will reduce the number of low-risk individuals being tested who are also at risk for false-positive TB test results, minimize the risk for significant side-effects of preventive treatment, and focus on completing preventive treatment for our high-risk populations. If the State of Hawai‘i TB Risk Assessment responses are negative (indicating low risk for TB exposure or TB disease progression), then asymptomatic individuals will not be required to undergo an actual test for TB infection. Instead, the provider may issue a TB clearance without administering a TST or other test for TB infection. For individuals meeting any of the high-risk criteria, and for all healthcare workers, an actual test for TB infection will still be required. With the new rules, any person born in a high-risk country where TB is poorly controlled will still require testing for TB infection. Other major risk factors for TB infection included in the State of Hawai‘i TB Risk Assessment include identifying children with foreign-born parents, individuals with a known exposure to active TB, or individuals with a prior history of a positive TB test. A copy of the draft State of Hawai‘i TB Risk
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 119
Assessment (with instructions and guidance for interpreting results) will soon be distributed to providers and institutions performing TB testing across the state. Some medical conditions may impart a smaller impact on the incidence of TB infection, but have been shown to dramatically increase the risk of progression to active TB, and therefore warrant a TB test. These risk factors include immunosuppression from various diseases (eg, HIV, end-stage renal disease) or medications (eg, prolonged use of corticosteroids, anti-tumor necrosis factor alpha medications, or immunosuppressive drugs used for organ transplantation). These conditions are included in the State of Hawai‘i TB Risk Assessment to aid the clinician in a decision to test for TB infection. After many years of routine TST testing in Hawai‘i, incorporating a risk-based approach to TB testing is a significant paradigm change that will be challenging to implement. The TB Control Branch estimates that 30% - 40% of all TB tests currently administered in Hawai‘i will no longer be required with the proposed TB screening rules. Clinicians can still obtain a TB test at their own discretion despite a negative initial TB screen, but the TB test will no longer be required by the State of Hawai‘i. New State TB Clearance Forms: In the past, if the TB screening test was negative, a TB clearance was provided to the individual who was tested. As required by the Hawai‘i Administrative Rules, the forms included TB test results. These TB test results were provided to the school registrar or the employer, who would often verify that an individual was properly cleared by the clinician. In order to provide greater protection of personal medical information, a new standardized State TB Clearance form has been created to be used by clinicians in the State. The new form will not include TB test results. Employers and school registrars will no longer be required to verify the TB screening results. New State TB Blood Tests: For individuals who require statemandated TB screening, current Hawai‘i Administrative Rules only allow for the TST as a test for TB screening. Other tests were not developed and sufficiently tested when these rules were developed. With its first use in 1918, the TST is often referred to as the oldest medical test still performed today. The TST is relatively inexpensive to administer (approximately $5 per test),
but requires a second visit 48 to 72 hours later and may have false positive results in younger foreign-born individuals who received Bacille Calmette–Guèrin (BCG) vaccine. Newer IGRA blood tests (QFT-gold®, T-Spot®) measure TB infection with greater specificity than the TST. With the proposed new rules, all CDC-approved, FDA-certified tests for TB infection will be accepted by the TB Program. Until the high cost of IGRA tests are significantly reduced, the TST will likely continue to be the primary testing methodology for many programs. At the present time, IGRA tests for TB infection are not recommended for children under age 5.7 Summary Working with Hawai‘i’s medical community, the State of Hawai‘i Department of Health TB Control Branch has reduced the rate of TB disease by 99% in the past 80 years. Despite this remarkable achievement, Hawai‘i TB rates continue to be among the highest in the United States, and TB control remains a public health priority for the State. In keeping with more recent screening recommendations, the TB Control Branch is changing our focus to test and prevent TB among individuals with the highest TB risk. Although the proposed new rules may require a significant adjustment for the Hawai‘i TB Control Branch and our partners in the medical community, these changes are needed to help us move forward in our shared goal to further reduce the morbidity and mortality of TB in our State. Authors’ Affiliations: - Communicable Disease and Public Health Nursing Division, State of Hawai‘i Department of Health, Honolulu, HI; and Centers for Disease Control and Prevention, Division of TB Elimination, Atlanta, GA (RB) - Communicable Disease and Public Health Nursing Division, State of Hawai‘i Department of Health, Honolulu, HI (GW) References
1. CDC. Reported tuberculosis in the United States, 2013. Atlanta, GA: US Department of Health and Human Services, CDC; 2014. 2. WHO Global TB Report 2015, accessed at http://www.who.int/tb/publications/global_report/ gtbr2015_executive_summary.pdf?ua=1. 3. CDC. Updated guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection—United States, 2010. MMWR. 2010;59(No. RR-5). 4. Annual Report of the Governor of Hawaii to the Secretary of the Interior for the Fiscal Year ended June 30, 1935. US Govt Printing Office, Washington DC, 1935. 5. American Academy of Pediatrics, Committee on Infectious Diseases (1994) Screening for tuberculosis in infants and children. Pediatrics. 93:131–134. 6. Miles JA. Public Health Progress in the Pacific: Geographical Background and Regional Development, Kluwer Academic Publishers Group, 1964. 7. CDC. Treatment of tuberculosis. MMWR. 2003;52(No. RR-11). 4. CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR. 2000;49(No. RR-6).
HAWAI‘I JOURNAL OF MEDICINE & PUBLIC HEALTH, APRIL 2016, VOL 75, NO 4 120
