Between October 2000 and October 2007, 79 patients receiving treatment for Latent TB Infection (LTBI) were reported to the Division of Tuberculosis Elimination (DTBE), Centers for Disease Control and Prevention (CDC) with severe adverse events to their medications (s). A severe adverse event is defined as a drug-related reaction resulting in hospitalization or death of a person receiving treatment for LTBI. Deaths reported among persons with LTBI included, 2 of 50 persons who were on the recommended two-month regimen of rifampin and pyrazinamide (RZ); 9 of 22 treated with isoniazid alone, and 2 of 3 patients on other regimens (e.g., pyrazinamide and ethambutol). Severe adverse events such as hospitalizations, liver transplants, and death related to treatment of LTBI continue to be reported to DTBE.
In order to determine risk factors and to monitor trends of severe adverse events related to the treatment of LTBI, CDC requests approval for information collection through the National Surveillance for Severe Adverse Events Associated with Treatment of LTBI. These reports are from healthcare providers and health departments (local/state/territorial) from any of the 60 reporting areas for the National TB Surveillance System (NTSS). CDC currently conducts and maintains NTSS pursuant to the provisions of Section 301 (a) of the Public Service Act [42 U.S.C. 241] and Section 306 of the Public Service Act [42 U.S.C. 241 (a)] which also authorizes this proposed information collection (Attachment 1).
In compliance with the recommendations of the Institute of Medicine (IOM), Ending Neglect: The Elimination of Tuberculosis in the United States towards reaching the Healthy People (HP) 2010 objective, CDC is detecting and treating latent TB infection (LTBI) through targeted testing and administration of LTBI treatment to prevent transmission. Persons with LTBI are at highest risk for progression from latent infection to TB disease. However, with the increased number of persons with LTBI who will be treated with the recommended regimen of antibiotics, we anticipate that severe adverse events will occur more frequently.
The purpose of this information collection request is to determine the annual number and trends of severe adverse events associated with treatment of LTBI and identify common characteristics of patients with severe adverse events during treatment of LTBI. The data will also guide the revision of the TB treatment protocols in order to prevent severe adverse events associated with treatment of LTBI. CDC will use the information to monitor trends in LTBI detection and compile the nature of severe adverse events to treatment regimens associating patient characteristics, clinical events and the treatment regimens that the patient has been required to take. Most importantly, the presence of HIV infections or HIV-related treatment regimens will be evaluated closely. The data will be used to generate trends and analyze associations of the severe reactions with patient characteristics or concurrent medications. CDC will use the cumulated data on LTBI treatment and severe adverse events to convene stakeholders and recommend revisions of current LTBI treatment regimens based on patient's medical history and the perceived risk of severe adverse events.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
A7_ConsentForm.doc
A1.Legislation.pdf
Adverse Events to LTBI Treatment (AELT) - Clerk