title: Pharmacy-based dispensing of antimicrobial agents without prescription in India: appropriateness and cost burden in the private sector.
abstract: BACKGROUND
  Inappropriate antibiotic use for treatment of common self-limiting infections is a major problem worldwide. We conducted this study to determine prevalence of non-prescription sale of antimicrobial drugs by pharmacies in Bangalore, India, and to assess their associated avoidable cost within the Indian private healthcare sector.
  
  
  METHODS
  Between 2013 and 2014, two researchers visited 261 pharmacies with simulated clinical scenarios; upper respiratory tract infection in an adult and acute gastroenteritis in a child. Using a pre-defined algorithm, the researchers recorded questions asked by the pharmacist, details of medicines dispensed, and instructions regarding drug allergies, dose and side effects.
  
  
  RESULTS
  Antimicrobial drugs were obtained without prescription from 174 of 261 (66.7 %) pharmacies visited. Instructions regarding dose of these drugs were given by only 58.0 % pharmacies. Only 18.4 % (16/87) of non-antimicrobial-dispensing pharmacies cited the need for a prescription by a medical practitioner. None gave advice on potential side effects or possible drug allergies. In the upper respiratory infection simulation, 82 (71.3 %) of the 115 pharmacies approached dispensed antimicrobials without a prescription. The most common antimicrobial drug prescribed was amoxicillin (51.2 %), followed by azithromycin and ciprofloxacin (12.2 % each). Among 146 pharmacies where acute gastroenteritis was simulated, 92 (63.0 %) dispensed antimicrobials. Common ones were fluoroquinolones (66.3 %), particularly norfloxacin in combination with metronidazole. Standard treatment for diarrhea such as oral rehydration solution and zinc was prescribed by only 18 of 146 (12.3 %) pharmacies. Assuming the average cost of a 5-day course of common antimicrobials in India is $1.93, with 2.5 and 2.1 annual episodes of adult upper respiratory and childhood gastrointestinal infections respectively, and with 30-45 % of the population of 1.3 billion visiting pharmacies, the estimated cost of unnecessary antimicrobial drugs dispensed by pharmacies in India would range from $1.1 to 1.7 billion.
  
  
  CONCLUSIONS
  The study shows that dispensing of antimicrobial drugs without prescription by pharmacies in the private sector in India within an urban setting was unacceptably high, thus placing a high burden on healthcare expenditure. There is an urgent need to institute measures to curb unnecessary antimicrobial usage in India, address market incentives and involve pharmacists as partners for creating awareness among communities.
authors.affiliation: Department of Pediatrics, St. John's Medical College Hospital, Bangalore, India ; Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden ; Department of Pediatrics, Division of Infectious Diseases, St. John's Research Institute, Sarjapur Road, Bangalore, 560034 India.
authors.forename: Anita
authors.identifier: 0000-0002-7204-8164
authors.initials: A
authors.lastname: Shet
authors.affiliation: Department of Pediatrics, St. John's Medical College Hospital, Bangalore, India.
authors.forename: Suba
authors.initials: S
authors.lastname: Sundaresan
authors.affiliation: Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Birger C
authors.initials: BC
authors.lastname: Forsberg
keywords: Antimicrobial resistance; Antimicrobial use; Non-prescription dispensing; Pharmacy practice