Antimalarial procurement in private-sector pharmaceutical outlets: decision-making complexities and implications for medicine quality in Tanzania.

Poor-quality medicines are a major threat to healthcare provision in low-income countries. The problem exacerbates disease vulnerabilities of already disadvantaged populations including children, women, and the elderly. However, while the higher-level structural drivers of this problem are well established, little is known about decision-making lower down pharmaceutical supply chains, and whether this might produce vulnerabilities for medicine quality. We conducted a mixed-methods study to explore retailer-supplier interactions and decision-making dynamics for antimalarial medicines in three regions of Tanzania: Tabora, Dodoma and Mbeya. A survey questionnaire was administered to 118 small scale-and mid-range retailers in urban and rural districts of the regions. We then conducted 12 in-depth interviews with staff and owners of medicine outlets in 2 districts of Tabora region to explore further the decision-making dynamics. Results show that private-sector retailers are driven first and foremost by business and economic practicalities when choosing a medicine supplier, prioritising low purchase price, free delivery, and availability of credit. Many also rely on suppliers with whom they have personal connections, developed either within or outside the business context. Medicine quality comes far lower down the list of priorities. These findings are perhaps not surprising in a context where businesses serving low-income customers are operating on very small margins. However, when price and personal connection eclipse any other considerations, there is a risk that poor-quality medicines may find their way into supply chains, especially in countries where regulatory capacity is limited, and pharmaceutical supply chains are complex and opaque.

Antimalarial stocking decisions among medicine retailers in Ghana: implications for quality management and control of malaria.

Global health efforts such as malarial control require efficient pharmaceutical supply chains to ensure effective delivery of quality-assured medicines to those who need them. However, very little is currently known about decision-making processes within antimalarial supply chains and potential vulnerabilities to substandard and falsified medicines. Addressing this gap, we report on a study that investigated decision-making around the stocking of antimalarial products among private-sector medicine retailers in Ghana. Licensed retail pharmacies and over-the-counter (OTC) medicine retail outlets were sampled across six regions of Ghana using a two-stage stratified sampling procedure, with antimalarial medicines categorised as 'expensive,' 'mid-range,' and 'cheaper,' relative to other products in the shop. Retailers were asked about their motivations for choosing to stock particular products over others. The reasons were grouped into three categories: financial, reputation/experience and professional recommendation. Reputation/experience (76%, 95% CI 72.0% to 80.7%) were the drivers of antimalarial stocking decisions, followed by financial reasons (53.2%, 95% CI 48.1% to 58.3%) and recommendation by certified health professionals (24.7%, 95% CI 20.3% to 29.1%). Financial considerations were particularly influential in stocking decisions of cheaper medicines. Moreover, pharmacies and OTCs without a qualified pharmacist were significantly more likely to indicate financial reasons as a motivation for stocking decisions. No significant differences in stocking decisions were found by geographical location (zone and urban/rural) or outlet (pharmacy/OTC). These findings have implications for the management of antimalarial quality across supply chains in Ghana, with potentially important consequences for malaria control, particularly in lower-income areas where people rely on low-cost medication.

Insights from a qualitative study of the procurement and manufacture of active pharmaceutical ingredients in India.

Medicine supply systems are a crucial part of health systems and access to effective essential medicines is a key pillar of Universal Health Coverage. However, efforts to expand access are compromised by the proliferation of substandard and falsified medicines. The vast majority of research to date on medicine supply chains has focused on the formulation and distribution of the finished product, overlooking the crucial steps of Active Pharmaceutical Ingredient production that precede this. In this paper, we draw on qualitative interviews with manufacturers and regulators in India to take a 'deep dive' into these understudied parts of medicine supply chains.

"It is very difficult in this business if you want to have a good conscience": pharmaceutical governance and on-the-ground ethical labour in Ghana.

The governance of pharmaceutical medicines entails complex ethical decisions that should, in theory, be the responsibility of democratically accountable government agencies. However, in many Low- and Middle-Income Countries (LMICs), regulatory and health systems constraints mean that many people still lack access to safe, appropriate and affordable medication, posing significant ethical challenges for those working on the "front line". Drawing on 18 months of fieldwork in Ghana, we present three detailed case studies of individuals in this position: an urban retail pharmacist, a rural over-the-counter medicine retailer, and a local inspector. Through these case studies, we consider the significant burden of "ethical labour" borne by those operating "on the ground", who navigate complex moral, legal and business imperatives in real time and with very real consequences for those they serve. The paper ends with a reflection on the tensions between abstract, generalised ethical frameworks based on high-level principles, and a pragmatic, contingent ethics-in-practice that foregrounds immediate individual needs - a tension rooted in the gap between the theory and the reality of pharmaceutical governance that shifts the burden of ethical labour downwards and perpetuates long-term public health risks.

Out of the boxes, out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain.

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.

Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania.

In 2012, the WHO launched its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, with the aim of improving the quality of reporting and using the data to inform post-market surveillance and build regulatory capacity. However, from a regulatory governance perspective, its effectiveness depends on the willingness and ability of actors 'on the ground' to identify, report and investigate possible infringements and to enforce penalties. This paper presents findings from 27 interviews with representatives of agencies charged with regulating pharmaceutical markets and 4 interviews with pharmaceutical industry representatives in Tanzania. Their experiences provide important insights into how the theorised mechanism between reporting and a reduction in undesirable behaviours can play out in a low-income context, revealing hidden assumptions about regulator behaviour and motivations. A combination of chronic under-resourcing, information gaps and enforcement challenges conspires to limit the efforts of local regulators to achieve the GSMS goals, shedding new light on the relationship between apparent 'misconduct' and structural constraints.

Managing uncertainty in medicine quality in Ghana: The cognitive and affective basis of trust in a high-risk, low-regulation context.

Where regulation is weak, medicine transactions can be characterised by uncertainty over the drug quality and efficacy, with buyers shouldering the greater burden of risk in exchanges that are typically asymmetric. Drawing on in-depth interviews (N = 220) and observations of medicine transactions, plus interviews with regulators (N = 20), we explore how people in Ghana negotiate this uncertainty and come to trust a medicine enough to purchase or ingest it. We identify two mechanisms - attempts to mitigate uncertainty through seeking observable signs of quality and attempts to reduce informational asymmetry - that underpin cognitive assessments of a medicine's trustworthiness. However, these 'cognitive' forms of trust assessment have limited traction where uncertainty is high and trustworthiness remains unknowable, so a third mechanism comes into play: one based on affective relationships within which transactions are socially embedded. Even these, however, cannot eliminate uncertainty, because of the dispersed and under-regulated nature of wider supply chains. In conclusion, we reflect on the need for careful research on actors' practices and decision-making across supply chains to inform more effective policy and regulation.

The application of Signalling Theory to health-related trust problems: The example of herbal clinics in Ghana and Tanzania.

In contexts where healthcare regulation is weak and levels of uncertainty high, how do patients decide whom and what to trust? In this paper, we explore the potential for using Signalling Theory (ST, a form of Behavioural Game Theory) to investigate health-related trust problems under conditions of uncertainty, using the empirical example of 'herbal clinics' in Ghana and Tanzania. Qualitative, ethnographic fieldwork was conducted over an eight-month period (2015-2016) in eight herbal clinics in Ghana and ten in Tanzania, including semi-structured interviews with herbalists (N = 18) and patients (N = 68), plus detailed ethnographic observations and twenty additional key informant interviews. The data were used to explore four ST-derived predictions, relating to herbalists' strategic communication ('signalling') of their trustworthiness to patients, and patients' interpretation of those signals. Signalling Theory is shown to provide a useful analytical framework, allowing us to go beyond the primary trust problem addressed by other researchers - cataloguing observable indicators of trustworthiness - and providing tools for tackling the trickier secondary trust problem, where the trustworthiness of those indicators must be ascertained. Signalling Theory also enables a basis for comparative work between different empirical contexts that share the underlying condition of uncertainty.