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American Public Health Association
133rd Annual Meeting & Exposition
December 10-14, 2005
Philadelphia, PA
APHA 2005
 
5104.0: Wednesday, December 14, 2005 - 1:15 PM

Abstract #114371

Patient reporting of adverse events during isoniazid treatment of latent tuberculosis infection

R. Margaret Whelan1, Julie Franks, PhD2, Nancy Holson, MPH3, Sharon B. Mannheimer, MD4, Yael Hirsch-Moverman, MPH5, and Wafaa El-Sadr, MD4. (1) Infectious Diseases Division, Columbia University/Harlem Hospital, 506 Lenox Ave, Room 3101A, New York, NY 10037, (2) Harlem Hospital Center, Columbia University/Harlem Hospital, 506 Lenox Ave, Room 3101A, New York, NY 10037, 212-939-2447, jf642@columbia.edu, (3) Division of Infectious Diseases, Harlem Hospital/Columbia University, 506 Lenox Ave, Room 3101A, New York, NY 10037, (4) Harlem Hospital Center, Columbia University College of Physicians and Surgeons, 506 Lenox Ave, Room 3101A, New York, NY 10037, (5) Kountz Pavillon, Columbia University/Harlem Hospital, 506 Lenox Ave, Room 3101A, new york, NY 10035

Background: Patients (pts) with adverse events (AEs) may become non-adherent or interrupt treatment (tx). We assessed AEs in pts prescribed 9 months of isoniazid (INH) for tx of Latent Tuberculosis Infection (LTBI).

Methods: Medical charts were reviewed in a sample of pts prescribed self-administered INH at an inner-city clinic. During the 9 months of INH tx, pts were scheduled for monthly follow-up visits, and providers asked a series of standard questions including: AEs experienced, whether they were taking tx and reasons for tx interruptions.

Results: Of 203 patients who returned for at least one follow-up visit, 70% were male; 34% African-American, 19% Latino, 38% African; and 68% foreign born; mean age was 39 years (range: 18-90). 51 AEs were reported by 43 pts in 1,285 visits (incidence rate: 4.0 AEs per pt-month). AEs included: fatigue (20.3%), abdominal pain (18.9%), peripheral neuropathy (16.2%), rash (10.8%), nausea (9.4%), anorexia (6.8%), fever (5.4%), and dark urine (5.4%). When asked directly if they experienced AEs, 36 pts reported AEs on 44 separate visits (86.3% of total AEs reported). 7 pts on 7 separate visits (13.7%) reported AEs only when asked why they had interrupted tx. In all cases, pts had already interrupted tx before AEs were reported.

Conclusions: AEs cause pt-initiated interruption of tx. Pts will not always report AEs when asked directly, leading to underreporting and varying AE incidence rates. Better methods for educating pts on and assessing for AEs may identify more AEs, reducing complications and non-adherence.

Learning Objectives:

Keywords: Tuberculosis, Treatment Adherence

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.

Tuberculosis Epidemiology

The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA