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TB Notes 2, 2001

International Activities Update

DOTS-Plus for MDR TB and the Green Light Committee

Drug-resistant TB arises from improper chemotherapy of drug-susceptible TB patients. This includes administration of improper treatment regimens by health care workers and lack of direct observation of patients. Essentially, drug resistance arises in areas with poor TB control programs (often a reflection of the lack of DOTS in such areas). Multidrug-resistant TB (MDR TB) is a specific form of drug-resistant TB caused by bacilli resistant to at least isoniazid and rifampicin, the two most powerful anti-TB drugs.

In areas of minimal or no drug-resistance, DOTS achieves cure rates of up to 95%, rates high enough to dramatically reduce the TB burden while preventing the emergence of drug-resistant TB. However, unlike drug-susceptible TB, which has a solid, effective management strategy, the management of drug-resistant TB is not codified. While drug-susceptible TB can be cured within 6 months, forms of drug-resistant TB such as MDR TB require extensive chemotherapy (which is also more toxic to patients) for up to 2 years.

Presently, TB is the leading infectious disease cause of death among persons 5 years of age and older (including at least 500,000 persons with TB and HIV), and is responsible for over 2 million deaths a year worldwide. The World Health Organization (WHO) estimates that one third of the world's population is infected with M. tuberculosis. The WHO/IUATLD Global Project on Drug Resistance Surveillance has found MDR TB (prevalence > 4% among new TB cases) in Eastern Europe, Latin America, Africa, and Asia. Mathematical modeling suggests that MDR TB needs to be aggressively managed, since the WHO DOTS strategy for control of drug-susceptible TB is not sufficient to control this deadly variant of TB. Given the increasing trend toward globalization, transnational migration, and tourism, all countries are potential targets for outbreaks. Outbreaks of MDR TB in the United States and Western Europe have been partially linked to sources in developing countries.

In 1998, in response to the growing threat of MDR TB, WHO and several partners around the world developed the concept of DOTS-Plus, a strategy currently under development and testing for the management of MDR TB. In 1999, WHO established "The Working Group on DOTS-Plus for MDR TB" to provide direction and coordination to WHO and its partners. The Working Group includes representatives of many organizations involved in the prevention and control of MDR TB, including CDC. The aims of the Working Group are to approve, conduct, and coordinate pilot projects based on the Guidelines for Establishing DOTS-Plus Pilot Projects for the Management of MDR TB, a document prepared by the Scientific Panel of the Working Group. In addition, the Working Group aims to improve access to second-line anti-TB drugs for DOTS-Plus pilot projects via mechanisms such as the Green Light Committee. The Green Light Committee was created as a subcommittee of the Working Group to ensure that the concessionally-priced second-line drugs were offered only to projects that were consistent with the above Guidelines.

DOTS-Plus is based on the foundation of the five tenets of the DOTS strategy. It takes into account specific issues (such as the use of second-line anti-TB drugs) that need to be addressed in areas where there is a high prevalence of MDR TB. Thus, DOTS-Plus works as a supplement to the standard DOTS strategy, to address multidrug-resistant TB in areas with significant levels of MDR TB. By definition, it is impossible to conduct DOTS-Plus in an area without having an effective DOTS-based TB control program in place. DOTS-Plus is not intended as a universal strategy. DOTS-Plus should be implemented in selected areas with moderate to high levels of MDR TB in order to combat an emerging epidemic.

"The Working Group on DOTS-Plus for MDR TB" identified the lack of access to second-line anti-TB drugs as one of the major obstacles to the implementation of DOTS-Plus pilot projects. The Working Group has made arrangements with the pharmaceutical industry to provide concessionally-priced second-line anti-TB drugs to DOTS-Plus pilot projects meeting the standards outlined in the Guidelines. Therefore, project teams can gain access to these discounted second-line drugs by applying to the GLC.

It is the task of the Green Light Committee to review applications from potential DOTS-Plus pilot projects and determine whether or not they comply with the Guidelines. Project managers interested in having their projects reviewed by the Green Light Committee should review the document Instructions for Applying to the Green Light Committee for Access to Second-line Anti-Tuberculosis Drugs, available from the WHO Web site: http://www.who.int. WHO and others have posted the meeting dates and application deadlines for 2001.

Key Points

  • DOTS prevents the emergence of drug-resistant TB and MDR TB by ensuring that patients adhere to the full course of treatment.
  • DOTS-Plus is designed to cure MDR TB using second-line anti-TB drugs.
  • DOTS-Plus is needed in areas where MDR TB has emerged due to previous inadequate TB control programs.
  • DOTS-Plus pilot projects are only recommended in settings where the DOTS strategy is fully in place to protect against the creation of further drug resistance.
  • It is vital for DOTS-Plus pilot projects to be implemented following the recommendations of the WHO Working Group on DOTS-Plus for MDR TB, to minimize the risk of creating drug resistance to second-line anti-TB drugs.
  • Before launching DOTS-Plus pilot projects, applicants are strongly recommended to consult WHO, and to apply to the Green Light Committee for specially-priced second-line anti-TB drugs.
  • With the coordination of "The Working Group on DOTS-Plus for MDR TB" and a partnership with industry, the prices of second-line anti-TB drugs have fallen considerably, making these drugs more accessible to patients in resource-poor countries.
—Reported by Peter Cegielski, MD, MPH
Division of TB Elimination
CDC Representative to the Green Light Committee

Update on the Electronic TB Class A/B Notification Project

Introduction

As indicated in the recent Institute of Medicine (IOM) report on TB, "the elimination of tuberculosis (TB) in the United States will increasingly depend on the elimination of TB among foreign-born individuals."1 To this end, the CDC Division of Global Migration and Quarantine (DQ) is moving forward with the development of an Internet-based information system for notifications regarding the arrival of persons with Class A/B TB. (Persons whose x-rays are compatible with TB and whose AFB smears are positive are designated as Class A, infectious TB; persons whose x-rays are compatible with TB but whose AFB smears are negative are designated Class B, noninfectious TB.) The goals of this new system are to increase the timeliness of these notifications to state and local health departments and to improve the data collection tool in order to provide meaningful data for evaluation of follow-up of Class A/B cases at the national, state, and local levels.

To accomplish these goals, DQ has established a working group, the Electronic Migration Notification System Working Group (Table 1), in collaboration with the Division of TB Elimination (DTBE), the National TB Controllers Association (NTCA), and representatives from several state and big city TB and Refugee Health Programs. DQ convened an initial working group meeting in June 2000 with a follow-up meeting in September 2000. As a result of these meetings, the working group provided input that helped DQ formulate a project plan for calendar year 2001. In addition, sub-working groups (SWGs) were convened to address specific issues affecting surveillance activities for persons with Class A/B TB conditions. One SWG focuses on the challenges of movement (subsequent migration) and is chaired by Shameer Poonja from Massachusetts. The second SWG, chaired by Subroto Banerji of California, is developing recommendations for revision of the current data collection tools, CDC Form 75.17 (Notice of Arrival of Alien with Tuberculosis & Report on Alien with Tuberculosis, for Class B aliens) and CDC Form 75.18 (Notice of Arrival of Alien with Tuberculosis Waiver & Report on Alien with Tuberculosis Waiver, for Class A aliens).

On April 19-20, 2001, DQ convened the third meeting of the Electronic Migration Notification System (EMNS) working group. Mr. Tony Perez, Director, DQ, and Dr. Ken Castro, Director, DTBE, opened the meeting. Mr. Perez commented that the success of the EMNS is a top priority for DQ; that the IOM TB report is timely; that timing is important for addressing TB among newly arrived foreign-born persons; and that success can be achieved only by communication with and commitment from all partners. Dr. Castro commented that although TB rates are at an all-time low among the general population, this is not the situation among foreign-born persons. He also stated that the IOM TB report is clear in its challenge to eliminate TB by focusing attention on these persons. Dr. Castro said that he sees the electronic notification system as a tool to use in achieving the elimination of TB; however, he believes that important questions are, "What will each partner do with the information?" and "How will it be used?" Dr. Castro feels this system is long overdue and DTBE’s commitment to it mirrors that of DQ.

Overview of Class B1/B2 TB Data

The DQ Information for Migrating Populations (IMP) database indicates that the number of Class A notifications was extremely low for fiscal year 1999 (FY99). For Class B notifications, California received the highest number (34% of the FY99 national total). The other EMNS working group states accounted for an additional 30% (Figure 1); New York State led these states with 8%. Nationally, almost two thirds of all Class B notifications were for persons classified as B2. Among the EMNS working group states, the proportion of Class B notifications for persons classified as B1 ranged from 20% to 43%; for persons classified as B2, the range was 57% to 77% (Figure 2). Both interesting and a bit concerning was the low return rate of the CDC Forms 75.17 and 75.18 from states to CDC/DQ. Overall, 64% of notifications in FY99 were returned to CDC/DQ; however, the return rate probably does not accurately reflect the percentage of people with TB classifications evaluated in each state.

Addressing the Challenges of Movement

As with active cases of TB, movement of persons with TB Class A/B presents challenges to the public health system with respect to timely notification, completion of the U.S. medical exam, and initiation and completion of an appropriate treatment regimen. The SWG on migration identified types of subsequent migration among persons with TB Class A/B notifications:

  • Known movement from jurisdiction to jurisdiction: the new contact or locating information is known;
  • Unknown movement from jurisdiction to jurisdiction: the initial health department is unaware that the migrant has relocated;
  • Temporary migration: the migrant indicates that he or she is temporarily traveling to another state and will return to the original state of residence;
  • Return to country of prior residence.

The migration SWG recommended the following definition for subsequent migration: Any movement of a newly arrived refugee or immigrant with an identified Class A or B TB condition who initiates or completes an evaluation in a jurisdiction other than his or her intended jurisdiction of residence.

The goal of the electronic system will be to alleviate the confusion and delays associated with subsequent migration. In the meantime, the migration SWG, in collaboration with DQ, will be proposing guidelines for state TB programs that will outline recommended steps for transferring current A/B notification paperwork between states.

Improving the Data Collection Tool

DQ has long recognized that CDC Forms 75.17 and 75.18 are inadequate to provide meaningful outcome analyses. To this end, a second SWG is addressing the much-needed revision of this data collection tool. The goal of the form-revision SWG is to create questions that-

  • Provide meaningful outcome analysis for program evaluation at the local, state, and national levels;
  • Use established variables from the RVCT (Report of Verified Case of Tuberculosis); and
  • Create data elements that will support the NEDSS/HISSB (National Electronic Data Surveillance System/Health Information Surveillance System Board) requirements.

Table 1: Electronic Migration Notification System Working Group Members

State/City Refugee Health Programs Subgroup Affiliations
CA Laura Hardcastle Migration
FL Laura Smith Migration
GA Alice Long  
IL Ho Tran  
MA Jennifer Cochran  
NY City Geevarghese Abraham Migration, Form Revision
NY City Burt Roberts  
TX Sam Householder Migration
VA Anna Davis Form Revision
     
State/City TB Control Programs  
CA Subroto Banerji Form Rev (Chair), Migr (Co-Chair)
Chicago Dennis Minnice  
Chicago Jason Nehal  
GA Beverly Devoe  
GA Rose Sales  
GA Carolyn Martin  
IL Michael Arbise  
MA Shameer Poonja Migration (Chair), Form Rev
NY City Errol Robinson Form Revision, Migration
NY State Noelle Howland  
TX Phyllis Cruise Migration
VA David Phillips  
     
NTCA Stefan Goldberg Form Revision
  Kathleen Moser Form Revision
CDC/DTBE    
Surv & Epi Branch Eileen Schneider Form Revision
Intl Activities Kayla Laserson Migration
Intl Activities Peter Cegielski  
Field Svcs Branch Paul Tribble  
     
CDC/DQ    
Data Mgmt Section Gary Armstrong Form Revision, Migration
  Wanda Hall Form Revision, Migration
  Roochi Sharma Form Revision, Migration
     
Migration and Health
Assessment Section
Susan Cookson Form Revision, Migration

Figure 1. Percentage of TB Class B Notifications by Select States, FY 1999

Pie Chart: Percentage of TB Class B Notifications by Select States
California received 34% of all Class B notifications in 1999. The other working group states received 30% of the notifications, and the remaining states received 36% of the Class B notifications.
Other Working Group states include: New York State (includes New York City), Illinois (includes City of Chicago), Texas, Florida, Georgia, Virginia, Massachusetts.
Source: CDC/Division of Global Migration & Quarantine, Information for Migrating Populations database, fiscal year 1999.

Figure 2. Percentage of TB Class B1/B2 Notifications, USA and States, FY 1999

Graph: Percentage of TB Class B1/B2 Notifications
In FY1999, about two thirds of all Class B notifications in the U.S. were Class B2. Among the working group states, 20% to 43% of Class B notifications were Class B1, and 57% to 77% were Class B2.
Source: CDC/Division of Global Migration & Quarantine, Information for Migrating Populations database, fiscal year 1999.

The form-revision SWG developed a series of research questions that were shared with the larger working group for input and discussion. There was a high level of agreement with regard to the research questions. In the coming months, the form-revision SWG will use the questions to identify the data elements, identify the subsequent migration variables, adapt the data elements to NEDSS requirements, and define the data elements. Once this has been accomplished, the form will be revised to accommodate the new or revised data elements. Future steps will be to pilot-test the form, submit the revised form to the Office of Management and Budget (OMB) for approval, develop instructions, and modify the DQ IMP database.

In addition, the form-revision SWG will work with DQ to develop policies and procedures for states to use to facilitate rapid reporting to DQ when a newly arrived migrant is found to have infectious (sputum smear–positive) TB. A questionnaire and procedure will be developed for reporting jurisdictions to use to provide information for those persons who are found to have infectious TB so that staff from the DQ Migrant and Health Assessment Section can initiate an overseas trace-back.

Information System Development

Eight states are pilot-testing the Internet-based notification system for Class A/B TB notifications, using the CDC Secured Data Network (SDN). The SDN is a secure Internet system developed and implemented by CDC based on industry standards and confidentiality guidelines. The SDN creates an information gateway by which CDC can securely exchange confidential and sensitive data with CDC field staff, researchers, and public health partners, such as state and local health departments. CDC has implemented the SDN to ensure that data transferred between health departments and CDC are encrypted, and therefore not accessible to unauthorized users during transmission over the Internet. The immediate plan is to make improvements to the current Class A/B information system so as to increase functionality and add the capacity for states to download their own data. Future plans are to revise the system to accommodate new variables for the forms 75.17 and 75.18, address movement, and include more information from the overseas screening.

Next Steps

DQ staff currently notify health departments by U.S. mail of immigrant and refugee arrivals. This involves forwarding copies of the overseas visa medical examination results, one element of which is the screening for infectious TB. Electronic notification will assist states in promoting early access to health services and appropriate evaluation for conditions identified during the overseas exam. While TB control programs view the development of an electronic notification system as a much-needed method to improve Class A/B TB notification, refugee health programs view the development of EMNS as the first step of a more comprehensive information system for the approximately 80,000 refugees arriving in the United States each year. DQ plans to address these competing needs by focusing on TB notification and using the success of this prototype system to support ongoing development of a more comprehensive electronic migrant notification system. The success of the third EMNS working group meeting could not have occurred without the strong level of commitment from our partners in the field and within CDC. The outcomes from the two SWGs have allowed us to address the challenges of subsequent migration as well as make progress in the redesign of the current data collection tool. A continued collaborative effort is the key to ensuring the implementation of a well-designed and functional electronic notification system for TB Class A/B notifications. With this system, the recommendation identified in the IOM TB report can be achieved and the elimination of TB within this population can come closer to reality.

Reference

  1. Institute of Medicine. Ending Neglect: The Elimination of Tuberculosis in the United States. Washington, DC: National Academy Press; 2000.

—Submitted by Subroto Banerji, MPH
PHA, DTBE, and California TB Control Branch,
Jennifer Cochran, MPH, Director,
Immigrant and Refugee Health Program,
Massachusetts Dept. of Public Health,
and Susan Cookson, MD, Chief,
Migration and Health Assessment Section, DQ

 


Released October 2008
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