title: Adverse events in the treatment of MDR-TB patients within and outside the NTP in Pham Ngoc Thach hospital, Ho Chi Minh City, Vietnam.
abstract: BACKGROUND
  Treatment outcomes of a high proportion of inpatients with multi-drug resistant tuberculosis (MDR-TB) were not reported to the Vietnamese National Tuberculosis Program because they received treatment outside of the green light committee (GLC) program. The study aimed (1) to describe the strengths and weaknesses of treatment of GLC and non-GLC MDR-TB patients as well as the factors influencing treatment completion and (2) to determine the incidence of adverse drug reactions.
  
  
  RESULTS
  This cross-sectional study comprised two elements: (1) in-depth interviews with clinical doctors, hospital pharmacists; and focus group discussions with MDR-TB patients; and (2) a review of the charts of all GLC and non-GLC MDR-TB patients in 2010. A total of 282 MDR-TB patients were recruited, including 79(28%) MDR-TB patients treated through the GLC program and 203(72%) MDR-TB patients treated outside of the GLC program. The main strengths of GLC treatment were the supply of quality assured second line TB drugs, routine monitoring and clinical evaluation, free diagnostic tests and close clinical monitoring. The greatest barriers to patients treated outside of the GLC program was difficulty paying for second line TB drugs and other treatment costs. There was no significant difference between the incidence of adverse events among GLC (46.8%) and non-GLC treated patients (52.2%; p = 0.417). Among 143 patients who reported 226 adverse reaction events, arthralgia/joint pain (35.8%), gastrointestinal (14.2%), ototoxicity (8.4%), cutaneous (6.6%), and giddiness (5.8%) were the most common.
  
  
  CONCLUSIONS
  The non-GLC MDR-TB patients face substantial barriers to treatment, and require greater support if they are to complete treatment and improve disease outcomes. Staff training about the management of adverse drug reactions is needed.
authors.affiliation: National Tuberculosis Programme Vietnam, Hanoi, Vietnam. nguyenbinhhoatb@yahoo.com.|Centre for Operational Research, International Union against Tuberculosis and Lung Disease, Paris, France. nguyenbinhhoatb@yahoo.com.
authors.forename: Nguyen Binh
authors.initials: NB
authors.lastname: Hoa
authors.affiliation: National Tuberculosis Programme Vietnam, Hanoi, Vietnam. vietnhung@yahoo.com.|Vietnam Association for Tuberculosis and Lung Disease, Hanoi, Vietnam. vietnhung@yahoo.com.
authors.forename: Nguyen Viet
authors.initials: NV
authors.lastname: Nhung
authors.affiliation: World Health Organization (WHO), Vietnam Country Office, Hanoi, Vietnam. phamh@wpro.who.int.
authors.forename: Pham Huyen
authors.initials: PH
authors.lastname: Khanh
authors.affiliation: Hanoi Medical University, Hanoi, Vietnam. nguyenviethai.hmu@gmail.com.
authors.forename: Nguyen Viet
authors.initials: NV
authors.lastname: Hai
authors.affiliation: Department of Epidemiology and Biostatistics, The Hanoi School of Public Health, Hanoi, Vietnam. btq@hsph.edu.vn.
authors.forename: Bui Thi Tu
authors.initials: BT
authors.lastname: Quyen
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006786:Hospitals, Urban / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy* / Q000453:epidemiology; D014744:Vietnam / Q000453:epidemiology
chemical_list: D000995:Antitubercular Agents