title: Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban India: a cross-sectional study.
abstract: BACKGROUND
  India's total antibiotic use is the highest of any country. Patients often receive prescription-only drugs directly from pharmacies. Here we aimed to assess the medical advice and drug dispensing practices of pharmacies for standardised patients with presumed and confirmed tuberculosis in India.
  
  
  METHODS
  In this cross-sectional study in the three Indian cities Delhi, Mumbai, and Patna, we developed two standardised patient cases: first, a patient presenting with 2-3 weeks of pulmonary tuberculosis symptoms (Case 1); and second, a patient with microbiologically confirmed pulmonary tuberculosis (Case 2). Standardised patients were scheduled to present each case once to sampled pharmacies. We defined ideal management for both cases a priori as referral to a health-care provider without dispensing antibiotics or steroids or both.
  
  
  RESULTS
  Between April 1, 2014, and Nov 29, 2015, we sampled 622 pharmacies in Delhi, Mumbai, and Patna. Standardised patients completed 1200 (96%) of 1244 interactions. We recorded ideal management (defined as referrals without the use of antibiotics or steroids) in 80 (13%) of 599 Case 1 interactions (95% CI 11-16) and 372 (62%) of 601 Case 2 interactions (95% CI 58-66). Antibiotic use was significantly lower in Case 2 interactions (98 [16%] of 601, 95% CI 13-19) than in Case 1 (221 [37%] of 599, 95% CI 33-41). First-line anti-tuberculosis drugs were not dispensed in any city. The differences in antibiotic or steroid use and number of medicines dispensed between Case 1 and Case 2 were almost entirely attributable to the difference in referral behaviour.
  
  
  CONCLUSIONS
  Only some urban Indian pharmacies correctly managed patients with presumed tuberculosis, but most correctly managed a case of confirmed tuberculosis. No pharmacy dispensed anti-tuberculosis drugs for either case. Absence of a confirmed diagnosis is a key driver of antibiotic misuse and could inform antimicrobial stewardship interventions.
  
  
  BACKGROUND
  Grand Challenges Canada, Bill & Melinda Gates Foundation, Knowledge for Change Program, and World Bank Development Research Group.
authors: McGill International Tuberculosis Centre & Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
authors: Srinath
authors: S
authors: Satyanarayana
authors: Development Research Group, The World Bank, Washington, DC, USA.
authors: Ada
authors: A
authors: Kwan
authors: Development Research Group, The World Bank, Washington, DC, USA.
authors: Benjamin
authors: B
authors: Daniels
authors: Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors: Ramnath
authors: R
authors: Subbaraman
authors: McGill International Tuberculosis Centre & Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
authors: Andrew
authors: A
authors: McDowell
authors: ACCESS Health International, Hyderabad, India.
authors: Sofi
authors: S
authors: Bergkvist
authors: Institute for Social and Economic Research on Development and Democracy, Delhi, India.
authors: Ranendra K
authors: RK
authors: Das
authors: Department of Anthropology, Johns Hopkins University, Baltimore, MD, USA.
authors: Veena
authors: V
authors: Das
authors: Development Research Group, The World Bank, Washington, DC, USA; Center for Policy Research, New Delhi, India.
authors: Jishnu
authors: J
authors: Das
authors: McGill International Tuberculosis Centre & Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada; Manipal McGill Center for Infectious Diseases, Manipal University, Manipal, India. Electronic address: madhukar.pai@mcgill.ca.
authors: Madhukar
authors: M
authors: Pai
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D003376:Counseling; D003430:Cross-Sectional Studies; D006801:Humans; D007194:India; D010594:Pharmacies / Q000600:supply & distribution*; D063487:Prescription Drug Misuse; D011795:Surveys and Questionnaires; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents