In many low- and middle-income countries, providers without formal training are an important source of antibiotics, but may provide these inappropriately, contributing to the rising burden of drug resistant infections. Informal providers (IPs) who practise allopathic medicine are part of India's pluralistic health system legacy. They outnumber formal providers but operate in a policy environment of unclear legitimacy, creating unique challenges for antibiotic stewardship. Using a systems approach we analysed the multiple intrinsic (provider specific) and extrinsic (community, health and regulatory system and pharmaceutical industry) drivers of antibiotic provision by IPs in rural West Bengal, to inform the design of community stewardship interventions. We surveyed 291 IPs in randomly selected village clusters in two contrasting districts and conducted in-depth interviews with 30 IPs and 17 key informants including pharmaceutical sales representatives, managers and wholesalers/retailers; medically qualified private and public doctors and health and regulatory officials. Eight focus group discussions were conducted with community members. We found a mosaic or bricolage of informal practices conducted by IPs, qualified doctors and industry stakeholders that sustained private enterprise and supplemented the weak public health sector. IPs' intrinsic drivers included misconceptions about the therapeutic necessity of antibiotics, and direct and indirect economic benefits, though antibiotics were not the most profitable category of drug sales. Private doctors were a key source of IPs' learning, often in exchange for referrals. IPs constituted a substantial market for local and global pharmaceutical companies that adopted aggressive business strategies to exploit less-saturated rural markets. Paradoxically, the top-down nature of regulations produced a regulatory impasse wherein regulators were reluctant to enforce heavy sanctions for illegal sales, fearing an adverse impact on rural healthcare, but could not implement enabling strategies to improve antibiotic provision due to legal barriers. We discuss the implications for a multi-stakeholder antibiotic stewardship strategy in this setting.

Antibiotic use in animal agriculture contributes significantly to antibiotic use globally and is a key driver of the rising threat of antibiotic resistance. It is becoming increasingly important to better understand antibiotic use in livestock in low-and-middle income countries where antibiotic use is predicted to increase considerably as a consequence of the growing demand for animal-derived products. Antibiotic crossover-use refers to the practice of using antibiotic formulations licensed for humans in animals and vice versa. This practice has the potential to cause adverse drug reactions and contribute to the development and spread of antibiotic resistance between humans and animals. We performed secondary data analysis of in-depth interview and focus-group discussion transcripts from independent studies investigating antibiotic use in agricultural communities in Uganda, Tanzania and India to understand the practice of antibiotic crossover-use by medicine-providers and livestock-keepers in these settings. Thematic analysis was conducted to explore driving factors of reported antibiotic crossover-use in the three countries. Similarities were found between countries regarding both the accounts of antibiotic crossover-use and its drivers. In all three countries, chickens and goats were treated with human antibiotics, and among the total range of human antibiotics reported, amoxicillin, tetracycline and penicillin were stated as used in animals in all three countries. The key themes identified to be driving crossover-use were: (1) medicine-providers’ and livestock-keepers’ perceptions of the effectiveness and safety of antibiotics, (2) livestock-keepers’ sources of information, (3) differences in availability of human and veterinary services and antibiotics, (4) economic incentives and pressures. Antibiotic crossover-use occurs in low-intensity production agricultural settings in geographically distinct low-and-middle income countries, influenced by a similar set of interconnected contextual drivers. Improving accessibility and affordability of veterinary medicines to both livestock-keepers and medicine-providers is required alongside interventions to address understanding of the differences between human and animal antibiotics, and potential dangers of antibiotic crossover-use in order to reduce the practice. A One Health approach to studying antibiotic use is necessary to understand the implications of antibiotic accessibility and use in one sector upon antibiotic use in other sectors.

Donors often fund projects that develop innovative practices in low and middle-income countries, hoping recipient governments will adopt and scale them within existing systems and programmes. Such innovations frequently end when project funding ends, limiting longer term potential in countries with weak health systems and pressing health needs. This paper aims to identify critical actions for externally funded project implementers to enable scale-up of maternal and newborn child health innovations originally funded by the Bill & Melinda Gates Foundation (‘the foundation’), or influenced by innovations that were originally funded by the foundation in three low-income settings: Ethiopia, the state of Uttar Pradesh in India and northeast Nigeria. We define scale-up as the adoption of donor-funded innovations beyond their original project settings and time periods. We conducted 71 in-depth, semi-structured interviews with representatives from government, donors and other development partner agencies, donor-funded implementers including frontline providers, research organisations and professional associations. We explored three case study maternal and newborn innovations. Selection criteria were: a) innovations originally funded by the Bill & Melinda Gates Foundation (‘the foundation’), or influenced by innovations that were originally funded by the foundation; b) innovations for which a decision to scale-up had been made, allowing us to reflect on the factors influencing those decisions; c) innovations with increased geographical reach, benefitting a greater number of people, beyond districts where foundation-funded implementers were active. Our data were analysed based on a common analytic framework to aid cross-country comparisons. Based on study respondents’ accounts, we identified six critical steps that donor-funded implementers had taken to enable the adoption of maternal and newborn health innovations at scale: designing innovations for scale; generating evidence to influence and inform scale-up; harnessing the support of powerful individuals; being prepared for scale-up and responsive to change; ensuring continuity by being part of the transition to scale; and embracing the aid effectiveness principles of country ownership, alignment and harmonisation. Six critical actions identified in this study were associated with adopting and scaling maternal and newborn health innovations. However, scale-up is unpredictable and depends on factors outside implementers’ control.

Although the overall rate of caesarean deliveries in India remains low, rates are higher in private than in public facilities. In a household survey in Delhi, for instance, more than half of women delivering in private facilities reported a caesarean section. Evidence suggests that not all caesarean sections are clinically necessary and may even increase morbidity. We present providers’ perspectives of the reasons behind the high rates of caesarean births in private facilities, and possible solutions to counter the trend. Fourteen in-depth interviews were conducted with high-end private sector obstetricians and other allied providers in Delhi and its neighbouring cities, Gurgaon and Ghaziabad. Respondents were of the common view that private sector caesarean rates were unreasonably high and perceived time and doctors’ convenience as the foremost reasons. Financial incentives had an indirect effect on decision-making. Obstetricians felt that they must maintain high patient loads to be commercially successful. Many alluded to their busy working lives, which made it challenging for them to monitor every delivery individually. Besides fearing for patient safety in these situations, they were fearful of legal action if anything went wrong. A lack of context specific guidelines and inadequate support from junior staff and nurses exacerbated these problems. Maternal demand also played a role, as the consumer-provider relationship in private healthcare incentivised obstetricians to fulfil patient demands for caesarean section. Suggested solutions included more support, from either well-trained midwives and junior staff or using a ‘shared practice’ model; guidelines introduced by an Indian body; increased regulation within the sector and public disclosure of providers’ caesarean rates. Commercial interests contribute indirectly to high caesarean rates, as solo obstetricians juggle the need to maintain high patient loads with inadequate support staff. Perceptions amongst providers and consumers of caesarean section as the ‘safe’ option have re-defined caesareans as the new ‘normal’, even for low-risk deliveries. At the policy level, guidelines and public disclosures, strong initiatives to develop professional midwifery, and increasing public awareness, could bring about a sustainable reduction in the present high rates.

Donors commonly fund innovative interventions to improve health in the hope that governments of low and middle-income countries will scale-up those that are shown to be effective. Yet innovations can be slow to be adopted by country governments and implemented at scale. Our study explores this problem by identifying key contextual factors influencing scale-up of maternal and newborn health innovations in three low-income settings: Ethiopia, the six states of northeast Nigeria and Uttar Pradesh state in India. We conducted 150 semi-structured interviews in 2012/13 with stakeholders from government, development partner agencies, externally funded implementers including civil society organisations, academic institutions and professional associations to understand scale-up of innovations to improve the health of mothers and newborns these study settings. We analysed interview data with the aid of a common analytic framework to enable cross-country comparison, with Nvivo to code themes. We found that multiple contextual factors enabled and undermined attempts to catalyse scale-up of donor-funded maternal and newborn health innovations. Factors influencing government decisions to accept innovations at scale included: how health policy decisions are made; prioritising and funding maternal and newborn health; and development partner harmonisation. Factors influencing the implementation of innovations at scale included: health systems capacity in the three settings; and security in northeast Nigeria. Contextual factors influencing beneficiary communities’ uptake of innovations at scale included: sociocultural contexts; and access to healthcare. We conclude that context is critical: externally funded implementers need to assess and adapt for contexts if they are to successfully position an innovation for scale-up.

Providers without formal training deliver healthcare and antibiotics across rural India, but little is known about the antibiotics that they stock. We conducted a cross-sectional survey of such informal providers (IPs) in two districts of West Bengal, and assessed the availability of the antibiotics, as well as their sales volumes, retail prices, percentage markups for IPs and affordability. Of the 196 IPs that stocked antibiotics, 85% stocked tablets, 74% stocked syrups/suspensions/drops and 18% stocked injections. Across all the IPs, 42 antibiotic active ingredients were stocked, which comprised 278 branded generics from 74 manufacturers. The top five active ingredients that were stocked were amoxicillin potassium clavulanate (52% of the IPs), cefixime (39%), amoxicillin (33%), azithromycin (25%) and ciprofloxacin (21%). By the WHO’s AWaRe classification, 71% of the IPs stocked an ACCESS antibiotic and 84% stocked a WATCH antibiotic. The median prices were in line with the government ceiling prices, but with substantial variation between the lowest and highest priced brands. The most affordable among the top five tablets were ciprofloxacin, azithromycin, cefixime and amoxicillin (US$ 0.8, 0.9, 1.9 and 1.9 per course), and the most affordable among the syrups/suspensions/drops were azithromycin and ofloxacin (US$ 1.7 and 4.5 per course, respectively), which are mostly WATCH antibiotics. IPs are a key source of healthcare and antibiotics in rural communities; practical interventions that target IPs need to balance restricting WATCH antibiotics and expanding the basket of affordable ACCESS antibiotics.