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Over-The-Counter Antibiotic Dispensing by Pharmacies Research BMJ Glob Health: first published as 10.1136/bmjgh-2019-001869 on 1 November 2019. Downloaded from Over- the- counter antibiotic dispensing by pharmacies: a standardised patient study in Udupi district, India Vaidehi Nafade,1,2 Sophie Huddart,1,2 Giorgia Sulis,1,2 Amrita Daftary,3 4,5 5,6 1,2,5 Sonal Sekhar Miraj, Kavitha Saravu , Madhukar Pai To cite: Nafade V, Huddart S, ABSTRACT Key questions Sulis G, et al. Over- the- counter Background Antimicrobial resistance is a global health antibiotic dispensing by emergency, and one of the contributing factors is overuse What is already known? pharmacies: a standardised and misuse of antibiotics. India is one of the world’s patient study in Udupi district, The overuse and misuse of antibiotics is a contribut- largest consumers of antibiotics, and inappropriate ► India. BMJ Global Health ing factor to antimicrobial resistance, and India con- use is potentially widespread. This study aimed to use 2019;4:e001869. doi:10.1136/ sumes the most antibiotics of any country. standardised patients (SPs) to measure over- the- counter bmjgh-2019-001869 Standardised patients (SPs) have been used to as- antibiotic dispensing in one region. ► sess quality of care in India and other low-income Methods Three adults from the local community in Udupi, Handling editor Seye Abimbola and middle-income countries, and have shown that India, were recruited and trained as SPs. Three conditions, in India, private retail pharmacies are a source of ► Additional material is in both adults and children, were considered: diarrhoea, non- prescription antibiotics. published online only. To view upper respiratory tract infection and acute fever. Adult SPs please visit the journal online These studies have reported that up to 40% of phar- were used as proxies for the paediatric cases. ► (http:// dx. doi. org/ 10. 1136/ macies provide non-prescription antibiotics, but Results A total of 1522 SP interactions were successfully bmjgh- 2019- 001869). the most studies are limited to one or two medical completed from 279 pharmacies. The proportion of SP conditions. interactions resulting in the provision of an antibiotic was Received 26 July 2019 4.34% (95% CI 3.04% to 6.08%) for adult SPs and 2.89% What are the new findings? Revised 28 September 2019 (95% CI 1.8% to 4.4%) for child SPs. In the model, referral ► In the district of Udupi, Karnataka, we completed Accepted 5 October 2019 to another provider was associated with an OR 0.38 (95% 1522 pharmacy–SP interactions including three CI 0.18 to 0.79), the number of questions asked was conditions in both adults and children— upper re- associated with an OR 1.54 (95% CI 1.30 to 1.84) and spiratory tract infection, diarrhoea and fever—and an SP–pharmacist interaction lasting longer than 3 min found that only 4% of pharmacies provided non- http://gh.bmj.com/ was associated with an OR 3.03 (95% CI 1.11 to 8.27) as prescription antibiotics. compared with an interaction lasting less than 1 min. ► Antibiotic dispensing was highest when pharmacies Conclusion Over- the- counter antibiotic dispensing rate asked more questions or spent more time with the was low in Udupi district and substantially lower than SP, and lowest when they referred the SP to another previously published SP studies in other regions of India. provider. Dispensing was lowest when pharmacies referred to a ► Despite the low rate of antibiotic dispensing, case doctor, and higher when pharmacies asked more questions management by pharmacies was still poor as eval- on September 30, 2021 by guest. Protected copyright. or spent more time with clients. uated by adherence to international guidelines, and varied greatly according to the condition presented and whether the SP was an adult or paediatric case. INTRODUCTION What do the new findings imply? Antimicrobial resistance is a global health ► In some areas of India, non-prescription antibiotic emergency, and poor antimicrobial steward- dispensing by pharmacies may not be as prevalent ship, which includes both overuse and misuse as previously thought, although overall quality of © Author(s) (or their of these drugs, is a contributing factor.1 Esti- care remains a problem. In addition to provider-level variation in antibiotic employer(s)) 2019. Re- use mates suggest that 20%–50% of global antibi- ► permitted under CC BY-NC. No 2 dispensing, geographical and demographic factors commercial re- use. See rights otic use is inappropriate, but it is difficult to may be relevant, though further research is required. and permissions. Published by measure this in resource-constrained settings BMJ. where surveillance is a challenge. For numbered affiliations see India is a leading consumer of antibiotics India also has a high infectious disease end of article. globally. Between 2000 and 2015, antibi- burden,4 and a high burden of mortality 5 Correspondence to otic consumption in India doubled, making due to drug- resistant pathogens. India has a Dr Kavitha Saravu; India the highest- consuming low-income and highly privatised medical system with a large kavithasaravu@ gmail. com middle- income country (LMIC).3 However, informal sector, and many patients access Nafade V, et al. BMJ Global Health 2019;4:e001869. doi:10.1136/bmjgh-2019-001869 1 BMJ Global Health BMJ Glob Health: first published as 10.1136/bmjgh-2019-001869 on 1 November 2019. Downloaded from antibiotics over the counter (OTC) via over 750 000 of visit, whether the SP was referred to another provider, retail pharmacies across the country,6 and it has been approximate time spent at the pharmacy and pharmacy documented that these pharmacies dispense antibiotics location (urban or rural)—were associated with antibi- without a prescription.7 otic dispensing. According to the Drugs and Cosmetics Rules Act from 8 the Indian government, all antibiotics are designated Standardised patients as Schedule H, which means that pharmacies cannot SPs are individuals recruited locally, trained to make iden- dispense them without a prescription. In 2013, in an tically scripted clinical presentations, deployed incog- effort to regulate use of certain antibiotics such as newer nito to visit healthcare providers and debriefed using cephalosporins and fluoroquinolones, carbapenems a structured reporting instrument. Table 1 summarises and antituberculosis drugs, the Indian government the three SP case scenarios. Treatment for each condi- introduced a second schedule, H1. Pharmacies must tion was benchmarked against available guidelines from maintain a register of all Schedule H1 drugs dispensed, WHO on the management of the common cold,19 diar- recording the name and quantity of the drug as well as 20 21 9 rhoea and suspected malaria ; antibiotics are not indi- patient details. A further schedule of drugs, schedule X, cated in any case. The appendix includes a description requires pharmacists to also keep the original prescrip- of all guidelines referenced to determine ideal manage- tion on hand for 2 years; this schedule includes restricted ment for each case. drugs such as narcotics and sedatives. Three adults were recruited from the local community Thus, OTC antibiotic dispensing is technically illegal, as SPs. For the paediatric scenarios, adults were used as but enforcement of these regulations is challenging. This proxy SPs—no children were recruited. The SPs were is concerning as overall antibiotic consumption in coun- instructed to visit the pharmacy and first request medica- tries has been linked to a higher prevalence of antibiotic tion for a sick 2- year- old child at home and then request resistance,10 and the use of antibiotics in the individual medication for their own illness. Thus, two cases were is linked with the subsequent emergence of resistant presented in a visit; each was considered a separate SP– bacteria in the body.11 Thus, the practice providing anti- pharmacy interaction. biotics without a diagnosis may unnecessarily promote resistance. Where prescription audits are not possible, stan- Selection of pharmacies and SP visits dardised (or simulated) patients (SPs) have been used The district of Udupi has a population of approximately to study pharmacy practices in India and other LMICs.12 1.2 million people, and, according to a list from the local The SP methodology is considered as the gold- standard pharmacists association, 350 private pharmacies were method to assess provider practice.13 14 Specifically in active at the time of the study. Ultimately, 279 pharma- India, this methodology has been successfully applied cies were included in our sample. Pharmacies were cate- to provide insight on how pharmacists manage cases of gorised as ‘urban’ or ‘rural’ according to census guide- 22 http://gh.bmj.com/ tuberculosis15 16 or respiratory tract infection17 for adult lines ; the sample included 155 rural pharmacies and patients and paediatric diarrhoea.16 18 These SP studies 124 urban pharmacies. Between 23 July 18 and 6 October have found that 15% to upwards of 40% of SP visits 2018, each SP was instructed to visit each pharmacy involved the provision of a non- prescription antibiotic. and present their respective adult and paediatric cases. We report here the results of a cross- sectional SP study Further information on sample size calculation and phar- assessing OTC antibiotic dispensing in private pharma- macy selection is available in online supplementary table cies in the district of Udupi, located in Karnataka state, S1 in the online supplementary appendix. on September 30, 2021 by guest. Protected copyright. India. This study builds on previous SP studies by our SPs were instructed to purchase any medications team14 15 by extending the number of case scenarios to provided and place them in labelled envelopes. SPs filled three common conditions: upper respiratory tract infec- out a structured questionnaire describing the visit using tion (URI), diarrhoea and fever suggestive of malaria. the EpiCollect 5 software on their mobile phones within half an hour of the interaction.
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