2.4.1 Antibiotic value chain mapping.

In the first part of the analysis we applied the heuristic principles of value chain analysis to map the chains and describe the value chain structure. Following the process indicated in Alarcon et al. [32], we identified nodes and node-interactions. These data were combined with the antibiotic flow diagrams created during each interview to generate three detailed value chain maps that capture the overall system and the diversity of antibiotic providers. The first map presented captures the manufacturing and initial distribution flows of the chains that are common to both study sites while the subsequent two maps capture the locally specific flow of antibiotics in each site. Those nodes reported to be similar were grouped together and key differences noted. The magnitudes of the antibiotic flows were presented qualitatively, based on the participant estimation, using thin to wide arrows.

2.4.2 Value chain power dynamics.

Power analysis is critical in understanding how health-related policies lead to inequal access to health care and identify entry points to improve health outcomes particularly by marginalised populations [46]. In our study, we focus on analysing power dynamics in value chains, following the framework developed by Dallas et al. [47]. The framework describes power through two facets. In the first, power is described in terms of the type of nodes involved, being either dyadic—occurring between two nodes—or collective—occurring between a group of nodes. In the second, power is described through the way it exerts influence and is either direct—being focused and having an obvious source and target—or indirect–occurring within a group of nodes due to changes in social structure and collective actions. The result of these variables suggests four types of power (Table 3); 1) bargaining, 2) institutional, 3) demonstrative, and 4) constitutive, though Dallas et al. [47] note the four are not mutually exclusive and some power dynamics may share multiple aspects.

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Table 3. A typology of power in value chains.

https://doi.org/10.1371/journal.pone.0281188.t003

Investigation of power relationships in the value chain provides an opportunity to consider the way actors interact with unintended consequences–or externalities–resulting from chain activities, an area largely absent from early value chain governance literature–e.g., Gereffi et al. [48], Kaplinsky and Morris [30] and Humphrey and Schmitz [49]. This phenomenon is well documented in research on, for instance, labour standards and working conditions where international NGOs, consumer groups, media and labour rights agencies influence value chain actors to adhere to sound working conditions along apparel global value chains [47]. Such evidence indicates that to understand value chain actors’ behaviours and rationales behind them, research needs to address the multiple kinds of influence and power, and the way these affect value chain actors activities [50]. An example of the way value chain work has been used to address sectors with negative health externalities is the tobacco industry. Goger et al.’s [51] examination of changing global tobacco value chains raises concerns over the potential negative impact of decreasing demand on small producers in tobacco dependent countries [51]. Historically, interventions to protect tobacco producers’ interests have primarily focused on crop substitution, but these have not always been successful. The authors argue that governance structures, institutional capacity building, and regulatory initiatives–i.e., the institutional power in the value chain–need to be considered to improve the success of tobacco alternatives for small producers.

Manifest content analysis was used to apply the power dynamic framework [47] to our interview data to identify factors contributing to antibiotic misuse and potential entry points for antibiotic stewardship. This type of qualitative analysis describes a structured, and detailed, approach towards descriptive accounts of interview data [52, 53] through a process of familiarisation, coding, and code restructuring to categorise data into groups and topics. Here, elements within participants responses are taken at having meaning at face value [52], i.e., a manifest approach, and are organised according to our study objectives and the power dynamic framework. Consequently, the interpretation of these descriptive findings occurs during our discussion. This is in contrast to other qualitative data analysis techniques, such as thematic analysis, which seek to provide explanation and interpretation through the act of generating themes [54] and is more applicable when datasets are derived from groups of similar individuals.

The primary author became familiar with the data by listening to and transcribing those interviews conducted in English, and by carefully reading all interview transcripts. Data coding began deductively based on topics from the interview guide (Table 2 & S1–S3 Files) and the power dynamics framework, after which codes were discussed with other co-authors experienced in qualitative analysis (PA, MG, AE). An initial codebook was developed and applied to transcripts, with additional codes being developed iteratively and inductively, i.e., a blended approach of deductive and inductive coding was utilised. Topic summaries were generated by combining individual codes and discussed between the research team during numerous group meetings. During analysis we took a critical realist experiential position to interpret the data [54]. Here, participants’ reported experiences of the antibiotic value chain are seen as containing ‘truth’ i.e., an experiential epistemological position.

3.2.1 Institutional power (direct, collective).

Dallas et al. [47] describe institutional power as being most clearly exercised by the public sector via national regulation and legislation–i.e., for our study this includes the laws governing antibiotic production, distribution, and prescription. As ABR is a public health issue–an example of negative externality [57, 58]—governments and regulatory bodies are responsible in controlling value chain actors’ behaviours to minimise ABR. We therefore begin our analysis by understanding the extent to which sectoral regulations, guidelines, and access to infrastructure influence stakeholder behaviours.

Lack of compliance with existing regulation. To ensure appropriate antibiotic use by citizens, regulations exist in India governing how antibiotics move from pharmaceutical companies to end users. Wholesaler licencing stipulates antibiotics are only sold to businesses with a retail licence. Retail licence legislation states pharmacies employ a registered pharmacist to be present during business hours. Prescribing legislation limits the prescribing of antibiotics to veterinarians. In other words, regulations aim to ensure antibiotic delivery is overseen by experts with medical knowledge. However, these regulations were poorly enforced in our study sites and illegal distribution and prescription of antibiotics occurs. Medical representatives acting for pharmaceutical companies sometimes supplied antibiotics directly to livestock healthcare providers and livestock keepers, some livestock healthcare providers who did not hold retail licences obtained antibiotics directly from wholesalers, and qualified pharmacists were rarely present in pharmacies:

“The reality is that hardly any time you will find them [pharmacists]. They will rather put their certificate on loan. So, if some moneyed man in village wants to start a chemist shop, he has to find a pharmacist in his locality, ‘why don’t you help me open my shop? I will give you 10,000 Rs or 20,000 Rs a month [approx. £100–200]’.” Pharmacology academics, Kolkata (KI-2-240919)

Pharmacy and drug shop owners, not pharmacists, often dispensed antibiotics either over the counter or via an informal prescription written by livestock healthcare providers who lacked the legal mandate to do so, such as Pranibandhu and para-vets.

The Drugs Control Office in the Gram Panchayats, who were responsible for enforcing medicine governance, including regulating the area’s 3,000 to 4,000 pharmacies, employed just five staff to conduct inspections. This lack of public sector enforcement capacity was coupled with concerns of corruption that further limited the effectiveness of inspections:

“If there is a raid and the drug inspector asks, ‘where is your pharmacist?’ and the pharmacist is not there, which most of the time they are not, then the inspector can close the pharmacy. But the inspector will not, as immediately the inspector will be bribed. There is hardly any punishment in the public system. You can call it a kind of dishonesty or corruption.” Pharmacology academics, Kolkata (KI-2-240919)

Consequently, commercially motivated actors were not obliged to conform to legislation designed to regulate, and potentially limit, their value chain activities.

Lack of guidance regarding responsible and prudent antibiotic usage. We also consider the role of professional associations such as veterinary statutory bodies and training centres in ensuring responsible and prudent antibiotic use. Here, another example of limited institutional power was the lack of antibiotic usage guidelines. We did not observe any government-based antibiotic usage guidelines and the only guidelines noted were those created and supplied by the veterinarians in Site 2 working for the NGO and in the government centres concerning production of small-scale commercial poultry systems. These written guidelines advised poultry producers to use antibiotics prophylactically to prevent respiratory and diarrhoeal diseases, including fluoroquinolones which are classified as highest priority critically important antibiotics for human health:

“From our institution one chart has been prepared from day one to day 35 [of poultry production]. Say from zero to four days tetracycline is used and from 22 to25 days another antibiotic, say enrofloxacin, is used for all the [birds] […] If any problem arises in that period then they use other antibiotics, say tylosin for respiratory tract infection.” Veterinarian, Site 2 (KI-1-130120)

The evidence from these findings suggests that existing regulations to ensure biomedical expertise regarding rational antibiotic use are not implemented and enforced. Moreover, the only antibiotic use guideline available was commercially motivated. Therefore, users lacked information that enabled them to use antibiotic appropriately. In fact, the converse was true, the information available to them and which they followed was sometimes inappropriate.

The ‘veterinary service lacuna’ creates opportunity for informal providers. In both study sites, livestock keepers only had access to a small number of veterinary medicine outlets–most of the pharmacies stocking veterinary medicines were in nearby towns rather than in the study sites. Furthermore, there was limited access to public veterinary services, with veterinary officers being stationed in local towns. This presented difficulties in accessing public livestock services, with livestock keepers citing the time and cost of getting to the block veterinary office as a barrier to access. Consequently, in both sites, livestock keepers received antibiotics through various livestock healthcare providers who lacked mandates to supply antibiotics to livestock, including human healthcare providers:

“The [veterinary] doctor isn’t always available. But the people at the pharmacy are also doctors. We tell them I have a cow and it looks sick, give us some medicine.” Livestock keeper, Site 1 (LK-5-010719)

While dual public-private practitioners—the Pranibandhu and Pranimitra- received no formal training on antibiotic use, para-vets working in site 2 received basic information on antibiotic use from the NGO. However, none of these stakeholders were legally allowed to prescribe antibiotics (Table 4). After training, Pranibandhu do not become officially employed by the government, working instead on a consultancy basis, being paid for the number of animals they artificially inseminate, a situation causing conflict among a group of Pranibandhu:

“We appeal in the high court. We are here for so long, we must be given some permanent post. An order was given once [by the government] that we should be permanent. But final order is yet to be released, the dates are pending. We Pranibandhu, are under the government but we don’t get any salary from them.” Pranibandhu, Site 1 (SH-5-191119)

Para-vets too, while retaining an association with the NGO training centre, receive no benefits from the government. The lack of legitimacy for these actors represents two problems. Firstly, livestock healthcare providers primarily generate income through medicine sales- including antibiotics- as described by this Pranibandhu:

“The training we received as Pranibandhu has been on artificial insemination. We weren’t asked to prescribe medication. But if we did just that we won’t make enough money, so we, on our own, have learnt how to use antibiotics from other veterinary doctors.” Pranibandhu, Site 1 (SH-5-110719)

Secondly, a void in prescribing control exists. The full gamut of prescribing habits cannot be monitored if the state refuses to acknowledge the role of informal providers in safeguarding animal health.

In summary, the lack of public and formal veterinarians encouraged informal livestock healthcare providers to emerge, most of whom prescribe antibiotics without the mandate to do so. As they are not recognised as formal antibiotic prescribers, they are unable to access formal training on appropriate antibiotic use and operate in a context where prescribing antibiotics is a tool to earn income and remains unmonitored by the state.

3.2.2 Bargaining power (direct, dyadic).

Bargaining power is described as a coercive type of power, occurring when a dominant actor or firm can coerce others into doing something that they may otherwise not do [47].

Pharmaceutical and wholesalers use incentives to promote antibiotic use. Medical representatives working for pharmaceutical and wholesale companies can be considered to exercise bargaining power for their companies over other value chain stakeholders. Here, representatives use incentives, providing stockists and retailers with access to credit, discounts and gifts for bulk purchase, promotional and educational schemes, and their ability to be highly mobile within the physical space of the value chain, to influence purchasers to buy certain types and volumes of antibiotics. Furthermore, some medical representatives interact with livestock healthcare providers and livestock keepers directly to promote antibiotic use. One para-vet discussed his frequent interaction with medical representatives:

“[I] have the phone number of medical representatives also, they sometimes come and tell [me] that this new medicine works better in this condition. And I used that [antibiotic] in the field, if it works I use it afterwards.” Para-vet, Site 2 (SH-1-130120)

This again highlights the commercial incentives for antibiotic use. Medical representatives have opportunity to generate additional profit for their companies by promoting antibiotic use.

3.2.3 Demonstrative power (indirect, dyadic).

When considering the type of demonstrative power operating in the value chain, we look to actors who are influencing others by establishing standards.

Livestock healthcare providers mimic others prescribing habits. We observed evidence of less experienced healthcare providers mimicking prescribing behaviour of more experienced providers–such as veterinarians–who exert demonstrative power by sharing their antibiotic practices within a local context:

“We have learnt how to use antibiotics from other veterinary doctors. For example, we would accompany them during their visits and learn which antibiotics are used when. This is how we learnt it.” Pranibandhu, Site 1 (SH-5-110719)

Some of these experienced veterinarians operating in the study sites were seen to be promoting antibiotic stewardship practices, and attempting to influence other livestock healthcare providers:

“We are trying to make the para-vets aware in a refresher training programme that you have to wait for three days. After [this], if it is not getting better then you can consult [us] and use antibiotics.” Veterinarian, Site 2 (KI-1-130120)

Similarly, one pharmaceutical representative discussed how they use their interactions with healthcare providers to disseminate information on medicine usage:

“We are doing a lot of para-vet conferences and company visits. We are trying to educate [them] in our own way. Some protocols are there, E. coli mastitis, different types of mastitis. We are giving information; which types of drugs are most effective.” Pharmaceutical representative, Kolkata (KI-%-200120)

However, as reported earlier (Section 3.2.1), we observed evidence of veterinarians developing and using antibiotic guidelines which contain practices deemed inappropriate–namely the prophylactic use of fluoroquinolones in poultry. Consequently, transfer of antibiotic use experience from more to less experienced, and formal to informal, healthcare providers may not always align with ideal antibiotic stewardship goals.

These instances are examples of how livestock healthcare providers maintain a close relationship with other value chain actors within which information on antibiotic use is shared. While the relationships are not formalised, formal veterinarians and medical representatives express demonstrative power regarding common practices of antibiotic provision over other less experienced livestock healthcare providers.

3.2.4 Constitutive power (indirect, collective).

Here we look to the social norms and understandings which surround antibiotic use and resistance in the study, to–as Dallas et al. [47] describe–“operate as a transmission mechanism for institutional reform”.

We observed varying levels of knowledge among our study participants concerning antibiotic use and resistance. Veterinarians and some medical representatives and livestock healthcare providers discussed concepts aligned with allopathic antibiotic stewardship such as spectrum of activity, diagnostic testing, and the negative consequences of antibiotic use such as side effects and resistance.

The responses of several livestock healthcare providers indicated that they had learned about antibiotics through many years of experience. Both the positive and negative effects of antibiotic usage were discussed, including possible side effects in livestock such as poor growth or abortion:

“Once I used sulpha drugs [such as the antibiotic sulfadiazine] for diarrhoea but then abortion happened. So, I stopped using sulpha drug in diarrhoea cases.” Para-vet, Site 2 (SH-1-130120)

Among pharmacy and drug shop owners and attendants, knowledge of antibiotics was variable, with some being unable to correctly identify antibiotics, reflecting the lack of formal training these stakeholders had received, as most are not pharmacists. Similarly, livestock keepers’ knowledge was also varied; while some were able to name certain antibiotics and demonstrate understanding of how antibiotics should be used properly—for example by following advice to complete a course of treatment—others thought that antibiotics could be used to treat viruses or were unfamiliar with the word ‘antibiotic’. Of those unfamiliar with the term antibiotic, further questioning revealed that many livestock keepers referred to the pharmaceutical treatments given to their livestock in broad terms such as ‘medicines’, ‘tablets’, or ‘injections’.

Antibiotics are considered essential for treating a range of conditions. What pervaded those stakeholders familiar with antibiotics was the close association antibiotics have with ‘modern’ medicine, with people talking about how antibiotics alleviate fear of bad outcomes and create confidence, and are therefore an integral part of healthcare:

“If I am not using antibiotics in cows and goats, there is no confidence whether it will be cured or not. If I use antibiotic I am confident that the animal must get well. If I don’t use [antibiotics], it would feel bad in my mind.” Para-vet, Site 2 (SH-1-130120)

“If a cow has a fever and I don’t use oxytetracycline, will that fever go down? I have to save [the cow]. Is there any way that without giving antibiotic the fever can be reduced? Is there any way the government of India [can] circulate [advice] among us?” Veterinary drug shop owner, Site 1 (SH-2-191119)

In addition, both livestock healthcare providers and livestock keepers have experienced that antibiotics are effective healthcare tools to prevent and treat illness in animals. These personal experiences have reinforced the notion that antibiotics are powerful, and therefore desirable, in treating disease and boosting farm productivity:

“In poultry it is very much necessary to use antibiotics, in case of animal [livestock] it is ok [not to], but in poultry, without antibiotic it is very hard to stop mortality. It is like that antibiotic has to be used every day.” Para-vet, Site 2 (SH-2-130120)

“When symptoms like fever occur, and two or three days [have] passed but it does not go down, if you give antibiotics it is cured quickly.” Pranimitra, Site 2 (SH-3-150120)

Consequently, social demand for antibiotics, whether appropriate or inappropriate, continues to be generated at the end of the value chain.

While some value chain actors demonstrated knowledge of antibiotic use in line with allopathic ideas of stewardship, many had limited knowledge, and commercial incentives to generate profit and obligational incentives to satisfy desires for positive clinical outcomes, may thus override opportunities to limit antibiotic use.

In summary, our power dynamic analysis demonstrates that the government currently lacks institutional power to influence value chain actors’ behaviours to use antibiotics appropriately. Pharmaceutical companies, wholesalers, and retailers motivated by profit generation face little interference from the state.

Because of the limited public sector capacity to provide adequate number of veterinarians for rural livestock keepers, for-profit actors have emerged at the end of the value chain to meet the demand for livestock healthcare, yet currently lack legitimacy and access to training opportunities to improve antibiotic use practices. Furthermore, a lack of guidelines for responsible and prudent use compounds the influence of for-profit actors and prevents deviation from strong social norms which continue to associate antibiotics as the most efficacious and safe therapeutic option for many diseases. As such, commercial interests and pressure to prescribe may incentivise stakeholders to deviate from appropriate use.