We performed a qualitative study of the social determinants of antibiotic use among community members in Haryana, India, to investigate how healthcare access, health knowledge, and income impacts patients’ antibiotic use practices. The study included semi-structured interviews and a cross-sectional survey. Interview and survey data from twenty participants were collected in July and August 2015. This study was nested within a larger mixed-methods study of antibiotic misuse and dispensing among community members and healthcare professionals.
Study population
Twenty participants were recruited in villages in the northern state of Haryana, India. Haryana borders the National Capital Territory of Delhi and has experienced rapid population growth over the past two decades due to high rates of immigration from other parts of India. The state’s poverty rate (12.50%), literacy rate (75.55%), and proportion of the population with a graduate education (12.39%) are improved compared to India as a whole (21.80, 72.98, and 9.51% respectively), while the under-eighteen percentage is similar (Haryana, 35.97%; India, 36.68%), and the level of homelessness is worse than the national average (0.20 vs. 0.15%) [22, 23].
The Indian village designation is based on population, not urbanicity, and ranges in size from less than 500 to over 10,000 people. Mid-sized villages, of population 2000–5000, account for nearly one-quarter of India’s overall population (23.8%) [24]. Three rural villages, Sikandarpur Badha, Bhirawati, and Silani, and two urban villages, Kadipur and Pratap Nagar, were selected for this study by convenience sampling. A pre-identified advocate in each village was utilized to increase support for the project within the communities.
A sample size of twenty interviews was finalized based on theoretical saturation. Theoretical saturation is a standard method for determining sample size in qualitative studies [26–28]. Using this method, saturation was reached and interviewing was stopped when interview responses became repetitive, such that little new material or analytic themes were gleaned from additional interviews. Fifteen community members were recruited by convenience sampling at local pharmacies, with the approval of the pharmacist or shop owner. To reach theoretical saturation, five additional people were recruited from nearby locations and roadside food stalls.
All English or Hindi speaking adults living in the state of Haryana who had purchased medicine from a pharmacy in the past three months were eligible to participate in the study. Exclusion criteria included being younger than eighteen, although ultimately no children sought enrollment in our study. Community members with formal degree-granting medical, pharmacy, or allied-health training, (e.g., Bachelor of Medicine and Surgery degree [MBBS] or Diploma in Pharmacy [D. Pharm]) were also excluded, because this group is not expected to be representative of the typical villager in terms of antibiotic knowledge and use practices.
Study definitions
In this study we used the terms antibiotic misuse and inappropriate use interchangeably. These terms were used to describe the following practices: 1) purchasing an incomplete dose of medication that is less than what was prescribed by an allopathic doctor, 2) stopping antibiotic treatment before all the doses are completed, 3) taking old antibiotics that were previously purchased to treat another illness, or 4) purchasing and taking any antibiotic without a prescription from an allopathic doctor. We categorized the first two practices as shortened antibiotic courses and the second two as antibiotic overuse (Fig. 1).
There are several potential meanings for the term “doctor” in India. To mitigate ambiguity, we refer to medical practitioners throughout this paper using designations based on the provider’s type and level of training. Allopathic medicine is a 5.5-years undergraduate program in India, leading to an MBBS. Doctors with an MBBS degree are the only providers who can legally prescribe antibiotics. Alternative medicine programs also require 5.5 years of undergraduate training, resulting in Bachelors degrees in Ayurvedic Medicine and Surgery (BAMS), Homoeopathic Medicine and Surgery (BHMS), Unani Medicine and Surgery (BUMS), etc. BAMS, BHMS, and BUMS doctors are fully trained in their respective alternative medical fields, but receive no allopathic medical training and are not licensed to prescribe or dispense antibiotics. Unlicensed rural medical practitioners (RMPs) are a third group that provides healthcare. These practitioners do not have formal medical training and cannot legally provide medical care, write antibiotic prescriptions, or dispense medications. Many RMPs worked previously as an assistant in the clinic of a qualified allopathic or alternative medicine doctor and their medical knowledge is gained by experience. In the absence of qualified MBBS practitioners, RMPs act as a primary source of healthcare in villages [29].
Pharmacies, called medical stores locally, are another first point of healthcare access. Pharmacist training is highly variable in India and dispensing of medications by employees with no formal pharmacy training is common (i.e. without a Diploma in Pharmacy or a Bachelors in Pharmacy) [30]. Throughout this paper we use the term pharmacist to refer to anyone dispensing medications at a medical store unsupervised, regardless of their clinical training.
Interviews
We conducted twenty semi-structured interviews to investigate antibiotic misuse among village community members. Figure 1 provided the rationale for the initial interview guide. This guide was refined twice during the study based on participant responses. Interview questions focused on two domains: typical antibiotic use and the motivation behind these practices. The term antibiotic was defined and common examples of this medication class were provided to all participants. To investigate typical antibiotic use we assessed participants’ preferred sources of healthcare in mild and serious illnesses, prescription usage when purchasing antibiotics, sharing of unused medication, and typical antibiotic course durations. To examine underlying motivations for these practices, we asked participants to discuss their economic situation, any prior education or training in health, and why they prefer certain types of healthcare. Sample questions include: What are your first and second preferred options for obtaining healthcare when you have a mild illness and why? and How important to you is the cost of a medication, when deciding to take less antibiotics than a doctor recommends?
All interviews were conducted by English-Hindi bilingual members of the study team in the language that the participant preferred. English and Hindi are the two official national languages of India. Hindi is the only official local language in Haryana and English fluency among village populations on specialized health topics was rare. Thus, most interviews were conducted in Hindi, with real-time translation into English. Interviews were audio recorded and most lasted ten to fifteen minutes. Transcription of the interviews for data analysis was conducted first in Hindi, with subsequent translation into English.
Analysis
Data analysis began during fieldwork, in order to identify reoccurring themes across participant responses. These initial findings motivated iterative re-workings of the interview guide, to delve deeper into the themes deemed most important or novel. Once data collection was complete, interview transcripts and open-ended survey data were analyzed with Nvivo software (Version 10.2, QSR International). Responses were coded for themes focusing on two domains: typical antibiotic use and the motivation behind these practices. Codes reflected the questions outlined in the interview guide. Two investigators independently coded the data and reviewed these analyses together.
Questionnaire
A Knowledge, Attitude, and Practices questionnaire was developed to assess health literacy, typical antibiotic use, and antibiotic knowledge. This questionnaire includes both open- and closed-ended questions and was adapted from other Knowledge, Attitude, and Practices surveys of antibiotic use in low resources settings [31–34]. The questionnaire has three sections: demographic information (occupation, education, income, etc.), antibiotic consumption (for the participant and their dependents), and antibiotic knowledge. It was finalized after review by an international (United States/India) study team, including two pharmacists, two infection control specialists, and an epidemiologist, and is available on request from the corresponding author.
The goal of the survey component of this study was to pilot test the questionnaire in our group of interview participants. Thus, the sample size was driven by the number of people interviewed (20) and the study was not powered for analytic statistical analysis. This paper presents descriptive statistics based on demographic information collected and responses to the open-ended survey question: Give your best definition of antibiotics.
Data quality
In designing our study, we were cognizant of the fact that our study population could have low health literacy and that the very term “antibiotic” might be poorly understood. Therefore, we proactively employed several techniques to facilitate the collection of high quality data. Prior to asking any questions including the word “antibiotic,” we asked participants if they had heard of the term, and if they had, we asked them to define it so that we could assess the accuracy of their understanding. All participants were then provided a definition for antibiotics and given several examples of common antibiotic commercial names used locally. Interview responses to key questions were also cross-checked with responses to six related questions in the structured questionnaire. In the case of discrepancy, the relevant parts of interview transcripts were reanalyzed and categorized based on confidence with the interview response.
Another potential data quality issue was ambiguity regarding colloquial use of the term “doctor.” Participants had a clear understanding of the differences between MBBS doctors and RMPs, and could easily identify providers of each type. However, because in India “doctor” can refer to a wide range of medical professions and expertise, we took particular care to have participants specify what they meant when using this word. The terms MBBS and RMP are used colloquially in these communities, so in times of ambiguity we asked the clarifying question “When you say doctor, do you mean MBBS, RMP, or someone else?”
Ethical approvals
The Institutional Review Board (IRB) at Medanta the Medicity Hospital, Haryana, India approved this study. An additional independent Ethics Committee at Medanta the Medicity Hospital also granted the study ethics approval. As with all human studies approved by the Institutional Review Board and Ethics Committee at Medanta the Medicity Hospital, a rigorous review and approval process was undertaken with particular consideration for the informed consent process. Our protocol specified that oral consent be obtained instead of written consent. This was because we expected that many participants would have low levels of literacy and we wanted to ensure protection of the rights of all study participants. All participants provided oral consent before any data were collected. A waiver of full review was requested from the Health Sciences IRB at the University of Wisconsin, because the risks for participants in this study were minimal. The Health Sciences IRB granted this study exemption from review. Participants were given 350 Indian Rupees, approximately $5.50 United States Dollars (USD), as compensation for their time. This was deemed an appropriate amount by members of the research team in Haryana.
