A multi-stakeholder approach towards operationalising antibiotic stewardship in India's pluralistic rural health system.

In this study we seek to develop a stewardship intervention that addresses two major interrelated challenges that India faces: increasing antimicrobial resistance (AMR) and a pluralistic health system with a large and unregulated informal health sector. AMR is high on India's policy agenda as it has one of the highest burdens of bacterial infections in the world and is also one of the world's biggest consumers of antibiotics (ABs) for human health. One of the major causes of increasing AMR is the excessive use of ABs in humans, animals and the environment.
A majority of healthcare providers in rural India, where 68% of the population lives, do not have a formal medical qualification but they fulfil a need for proximate healthcare that the formal health sector has not been able to fill. They are the first contact providers for a variety of illnesses, who frequently and inappropriately treat with ABs. Some states in India, including West Bengal, Bihar and Andhra Pradesh are implementing programmes of training and integrating informal providers (IPs) but evaluations suggest that providers' use of antibiotics has proven difficult to change. We conducted a study in 2016-17 (funded by HSRI Call 3) in rural West Bengal to understand the social, economic and behavioural drivers of antibiotic use (ABU) by IPs in order to address the root causes and develop tailored solutions. We found that the key drivers lay beyond IPs' individual economic needs and knowledge gaps. There was a strong influence of the pharmaceutical industry's aggressive marketing of antibiotics, and the regulatory and health systems had limited resources and capacity to provide stewardship in this health market. Although IPs' integration had initially been opposed by the Indian Medical Association at present there were mutually supportive relationships between informal providers and formal doctors (both public and private) on an individual level. IPs learned from formal doctors who have also been found to prescribe inappropriately. Other drivers were communities' low awareness about the long term dangers of inappropriate antibiotic use, and low purchasing power for full courses. We found that about a quarter of the IPs also treated animals, typically with the same antibiotics as humans. To contain antimicrobial resistance (AMR), we need to work collectively with these diverse stakeholders to arrive at solutions through deliberations and consensus. In this study we propose to co-design an intervention with multiple stakeholders to serve as an effective model of antibiotic stewardship and health systems strengthening at this level.
We will start with formative research in two rural locations in district South 24 Parganas in West Bengal (where our previous study was located) to supplement the data that we have collected in our earlier study. During this phase we will explore antibiotic use with animals in more detail, map the pharmaceutical supply and value chains for human and animal ABU, conduct a stakeholder analysis, map community platforms for behavioural communication and conduct a secondary data review of local AMR prevalence.
This will be followed by an intervention development phase where we will work with key stakeholders identified through the stakeholder analysis using 'Deliberative Mapping', a participatory methodology used with multiple stakeholders for democratic decision making. The intervention options that arise from this process will be further developed and piloted with a small group of providers, about 20 in each site. Evaluation will consist of a feasibility analysis of what worked and did not work, any changes in antibiotic use by IPs (IP and patient exit interviews), and analysis of the actions and reactions of stakeholders during the co-design phase to provide systematic learning to support the design of strategies for strengthening stewardship at scale in future, both in India as well as in similar settings in South Asia and Africa.

Antimicrobial Resistance (AMR) is high on India's health policy agenda as the country has one of the highest burdens of bacterial infections in the world. This disease burden is potentially a risk factor for high antibiotic consumption leading to the emergence and spread of AMR. One of the greatest challenges for containing AMR in Low and Middle-Income Countries (LMICs) like India is the complex and pluralistic health system. Over 70% of the population seeks healthcare from private providers; of these, more than 70% do not have a formal medical qualification. These informal providers (IPs) use a variety of antibiotics and in an earlier study we found that the drivers of high antibiotic use included the pharmaceutical industry's aggressive promotion of antibiotics, the weak capacity and ethical dilemmas of the regulatory system to restrict 'excess' without ensuring 'access', the influence of formal doctors' often inappropriate prescribing practices and patchy public perceptions of antibiotics intertwined with providers' perceptions that favoured short term patient outcomes over long term risks. A quarter of IPs also treated animals. Solutions to this situation will necessarily need to engage with multiple stakeholders in building consensus and compromise to move beyond individual gains towards the greater common good.

In this study we propose to co-design and pilot a multi-stakeholder antibiotic stewardship intervention to reduce and improve IPs antibiotic use in two rural sites in district South 24 Parganas in West Bengal. We will use a participatory methodology called Deliberative Mapping. The resulting intervention will be evaluated for its feasibility and acceptability, provider level outcomes, and for its effect on the stakeholders, individually and collectively. The evidence generated by this study will inform strategies for improving the performance of informal providers at scale in West Bengal and other Indian states and stimulate international debates.

India is demonstrating increasing commitment to universal health coverage by adopting task shifting of human resources, and promoting public private engagements in the health sector. Several states including West Bengal, Andhra Pradesh and Bihar are training and integrating informal providers (IPs) into the health system as they present a huge opportunity for expanding public health services to rural and remote populations. The Indian government has also articulated its commitment to addressing the challenge of AMR using a systems approach through a National Action Plan for Anti-Microbial Resistance drafted in 2017.
Our study will contribute to both these in-country developments by creating a model of stewardship that will (a) lead to improving quality of care in the rural primary healthcare market by creating suitable public-private and informal-formal linkages, that can advance the country's universal healthcare agenda, and (b) lead to more effective containment of antibiotic resistance in the pluralistic health system for humans and animals at the grass roots. We will work closely with key stakeholders including health policymakers, regulators, formal doctors and veterinarians, members of medical associations, pharmaceutical leaders, providers and communities, to strengthen participatory governance, accountability and regulation, and plug existing information asymmetries. Working with multiple stakeholders is the best way we can address this double-edged situation in which IPs are the backbone of the rural health service delivery system but also contributors to AMR through overuse of antibiotics due to multiple driving forces.
These stakeholders, present and potential ones (when study findings are brought to scale) will be the immediate beneficiaries of our work. Pharmaceutical and health and regulatory system actors will develop an enhanced understanding of their accountability and role in addressing AMR, and increase their capacity for harnessing the plurality of India's rural health market for greater public health gains. Providers and communities will benefit from enhanced knowledge leading to long term behaviour change in antibiotic use in humans and animals.
Our intervention can be integrated into ongoing informal provider training programmes in India, starting with West Bengal, and also in other countries. We will hold a final dissemination in India (budgeted) and a regional one for representatives from neighbouring countries engaged in similar work. We will also write blogs and newspaper articles. All team members will be involved in authoring high quality journal articles and participating in conferences.
When scaled up, our work will contribute to the reduction of antibiotic resistance and to the burden of antibiotic resistant infections which place a substantial strain on the country's healthcare system. Purchasing antibiotics for animal and human health needs can represent a high proportion of out-of-pocket household expenditure and can increase poverty in already poor households. Treating more resistant infections also adds to households' economic burden as more intensive and expensive antibiotics must be used. Arresting antibiotic resistance at the grass roots will economically benefit individual households and the country as a whole, and contribute to lowering antibiotic resistance globally. Increasing the effectiveness of public health services and health policy in India will lead to fostering its social and economic competitiveness on the global stage.
While we recognise that there may be resistance to IP interventions from some quarters of the formal medical sector, and that reaching a consensus across diverse stakeholders will be challenging, we would argue that the process itself will encourage stakeholders to understand and negotiate their own and others' interests, and to actively consider the greater common good of improved antibiotic use.