The role of constraints and information gaps in driving risky medicine purchasing practices in four African countries.

Substandard and falsified (SF) medical products pose a major threat to public health and socioeconomic development, particularly in low- and middle-income countries. In response, public education campaigns have been developed to alert consumers about the risks of SF medicines and provide guidance on 'safer' practices, along with other demand- and supply-side measures. However, little is currently known about the potential effectiveness of such campaigns while structural constraints to accessing quality-assured medicines persist. This paper analyses survey data on medicine purchasing practices, information and constraints from four African countries (Ghana, Nigeria, Sierra Leone and Uganda; n > 1000 per country). Using multivariate regression and structural equation modelling, we present what we believe to be the first attempt to tease apart, statistically, the effects of an information gap vs structural constraints in driving potential public exposure to SF medicines. The analysis confirms that less privileged groups (including, variously, those in rural settlements, with low levels of formal education, not in paid employment, often women and households with a disability or long-term sickness) are disproportionately potentially exposed to SF medicines; these same demographic groups also tend to have lower levels of awareness and experience greater levels of constraint. Despite the constraints, our models suggest that public health education may have an important role to play in modifying some (but not all) risky practices. Appropriately targeted public messaging can thus be a useful part of the toolbox in the fight against SF medicines, but it can only work effectively in combination with wider-reaching reforms to address higher-level vulnerabilities in pharmaceutical supply chains in Africa and expand access to quality-assured public-sector health services.

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.

Can a Smartphone Application Help Address Barriers to Reporting Substandard/Falsified Medical Products? A Pilot Study in Tanzania and Indonesia.

INTRODUCTION: Reporting is an essential component of efforts to combat the distribution and circulation of substandard and falsified (SF) medical products worldwide. However, little is known about why health care professionals (HCPs) do not report suspect products to the national medicine regulatory authority (NMRA) and what measures might address this. This pilot study aimed to assess the utility of a smartphone application for reporting SF medical products in Tanzania and Indonesia. METHODS: At baseline, in 2017, HCPs completed a survey describing perceived barriers to reporting and received training in the identification of SF products and received use of the smartphone reporting application (N=309). The application reporting system was piloted for 6 months. Evaluations took place with HCPs and NMRA staff at the midpoint and endline of the pilot study (2018). RESULTS: At baseline, HCPs surveyed (n=254) identified the following key barriers to reporting: difficulties identifying SF products, frustrations with existing reporting systems, and fears that reporting may have personal or reputational repercussions. During the pilot period, HCPs submitted a total of 36 reports of 27 products to the NMRAs in their respective countries; of these, 8 products were determined to be SF and 2 were unregistered. In all 10 cases, appropriate regulatory action was taken. Feedback from HCPs and NMRA staff was positive in both countries, suggesting that the application addressed several barriers to reporting as it was convenient and, importantly, opened a line of communication between HCPs and the NMRA. However, the application did not address all barriers to reporting, such as concerns of repercussions. CONCLUSION: The findings suggest that this smartphone application may be useful for improving HCPs' reporting of suspected SF products. Developing and piloting similar reporting applications in other countries and contexts is required.

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.

Community health workers and health equity in low- and middle-income countries: systematic review and recommendations for policy and practice.

BACKGROUND: The deployment of Community Health Workers (CHWs) is widely promoted as a strategy for reducing health inequities in low- and middle-income countries (LMIC). Yet there is limited evidence on whether and how CHW programmes achieve this. This systematic review aimed to synthesise research findings on the following questions: (1) How effective are CHW interventions at reaching the most disadvantaged groups in LMIC contexts? and (2) What evidence exists on whether and how these programmes reduce health inequities in the populations they serve? METHODS: We searched six academic databases for recent (2014-2020) studies reporting on CHW programme access, utilisation, quality, and effects on health outcomes/behaviours in relation to potential stratifiers of health opportunities and outcomes (e.g., gender, socioeconomic status, place of residence). Quantitative data were extracted, tabulated, and subjected to meta-analysis where appropriate. Qualitative findings were synthesised using thematic analysis. RESULTS: One hundred sixty-seven studies met the search criteria, reporting on CHW interventions in 33 LMIC. Quantitative synthesis showed that CHW programmes successfully reach many (although not all) marginalized groups, but that health inequalities often persist in the populations they serve. Qualitative findings suggest that disadvantaged groups experienced barriers to taking up CHW health advice and referrals and point to a range of strategies for improving the reach and impact of CHW programmes in these groups. Ensuring fair working conditions for CHWs and expanding opportunities for advocacy were also revealed as being important for bridging health equity gaps. CONCLUSION: In order to optimise the equity impacts of CHW programmes, we need to move beyond seeing CHWs as a temporary sticking plaster, and instead build meaningful partnerships between CHWs, communities and policy-makers to confront and address the underlying structures of inequity. TRIAL REGISTRATION: PROSPERO registration number CRD42020177333 .

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.

The role of support groups in the management of Parkinson's disease in Kenya: Sociality, information and legitimacy.

Parkinson's disease (PD) is the second most common neurodegenerative disease globally. It is a progressive neurological disorder which can lead to a decline in wellbeing and quality of life for people living with PD (PwP) and their families/caregivers. However, little is known about the experience of PwP in low- and middle-income countries. In high-income countries, the benefits of support groups in providing social support, preventing social isolation and normalising the PD experience have been established. As part of a wider ethnographic study over 10 months, we explored the role of support groups in the management of PD in Kenya, sub-Saharan Africa. Fifty-five PwP and 23 informal family caregivers took part, and observations took place over ten support group meetings. Both positives and drawbacks were identified. The groups played a role in filling in gaps in information and services that the healing landscape in Kenya was unable to provide, while acting as an important source of care and support for PwP and caregivers, enabling 'sociality' and legitimacy. Drawbacks included limited reach and accessibility, 'social comparisons', and seeing the severity of progressed PD in others. Findings suggest PD support groups could become important components within resource-constrained healthcare settings.

Formalising 'informal' mHealth in Ghana: Opportunities and challenges for Universal Health Coverage (UHC).

While mobile phones promise to be an important tool for bridging the healthcare gaps in resource-poor areas in developing countries, scalability and sustainability of mobile phones for health (mhealth) interventions still remain a major challenge. Meanwhile, health workers are already using their own mobile phones (referred to as 'informal mhealth') to facilitate healthcare delivery in diverse ways. Therefore, this paper explores some strategies for integrating 'informal mHealth' in the healthcare delivery of Ghana, by highlighting some opportunities and challenges. The study mainly employed a combination of literature review, focus group discussions and key informant interviews with community health nurses (CHNs) and other stakeholders, who were purposively selected from the three ecological zones in Ghana. The study found that, while scale-up of 'formal mhealth' remains challenging in Ghana, almost all CHNs in our study are using their personal mobile phones 'informally' to bridge healthcare gaps, thereby promoting universal health coverage. This provides opportunities for promoting (or formalising) 'informal' mhealth in Ghana, in spite of some practical challenges in the use of personal mobile phones that need to be addressed to ensure sustainable healthcare delivery in the country.

Mobile phone use and the welfare of community health nurses in Ghana: An analysis of unintended costs.

The use of mobile phones is fast transforming the healthcare delivery landscape in Ghana. A substantial number of health facilities are now dependent on mobile phones to facilitate their work. Evidence of the use of mobile phones in Ghana's healthcare is however limited. In order to contribute to the evidence of the value of using mobile phones to promote healthcare, we interrogated and highlighted unexpected costs imposed on community health nurses who use their personal mobile phones for healthcare delivery in the country. Data for the study were derived from 598 completed questionnaires and extracts from focus group discussions with community health nurses who were sampled from three regions across the three main ecological zones of Ghana. The results show that over 90% of nurses bear the cost of paying for airtime, bundles and chargers used for work-related activities, yet less than 10% of them receive direct compensation. This costly burden has the potential to demotivate the nurses and threaten the country's progress towards the achievement of universal health coverage. More significantly, the data strongly suggest that physical distance, regional location and gender are the main factors triggering extra costs incurred by the nurses. We conclude that the use of personal mobile phones for healthcare delivery imposed huge financial burden on community health workers in Ghana. A suggested intervention to forestall negative consequences on performance is to offer incentive packages to nurses as a compensation for the financial and non-physical costs of using personal mobile phones for work-related activities.

"Old people problems", uncertainty and legitimacy: Challenges with diagnosing Parkinson's disease in Kenya.

Very little is known about the experience of people living with Parkinson's disease (PD) in low- and middle-income countries, such as those in sub-Saharan Africa. The number of specialists in the region is low and awareness is limited among the population and healthcare professionals. Drawing on ten months of ethnographic fieldwork in urban and rural Kenya with 55 people living with PD (PwP), 23 family members and 22 healthcare professionals from public and private clinics, we set out to understand the experience of diagnosis among PwP in Kenya. The diagnostic journeys of our study participants were typically long, convoluted and confusing. Lack of relevant information, combined with comorbidities and expectations about 'normal' ageing, often conspired to delay interactions with health services for many. There often followed an extended period of diagnostic uncertainty, misdiagnosis and even 'undiagnosis', where a diagnostic decision was reversed. Following diagnosis, patients continued to lack information about their condition and prognosis, making it difficult for friends, family members and others to understand what was happening to them. We suggest that awareness of PD and its symptoms needs to improve among the general population and healthcare professionals. However, diagnosis is only the first step, and needs to be accompanied by better access to information, affordable treatment and support.

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.

Informal mhealth at scale in Africa: Opportunities and challenges.

The extraordinary global growth of digital connectivity has generated optimism that mobile technologies can help overcome infrastructural barriers to development, with 'mobile health' (mhealth) being a key component of this. However, while 'formal' (top-down) mhealth programmes continue to face challenges of scalability and sustainability, we know relatively little about how health-workers are using their own mobile phones informally in their work. Using data from Ghana, Ethiopia and Malawi, we document the reach, nature and perceived impacts of community health-workers' (CHWs') 'informal mhealth' practices, and ask how equitably these are distributed. We implemented a mixed-methods study, combining surveys of CHWs across the three countries, using multi-stage proportional-to-size sampling (N = 2197 total), with qualitative research (interviews and focus groups with CHWs, clients and higher-level stake-holders). Survey data were weighted to produce nationally- or regionally-representative samples for multivariate analysis; comparative thematic analysis was used for qualitative data. Our findings confirm the limited reach of 'formal' compared with 'informal' mhealth: while only 15% of CHWs surveyed were using formal mhealth applications, over 97% reported regularly using a personal mobile phone for work-related purposes in a range of innovative ways. CHWs and clients expressed unequivocally enthusiastic views about the perceived impacts of this 'informal health' usage. However, they also identified very real practical challenges, financial burdens and other threats to personal wellbeing; these appear to be borne disproportionately by the lowest-paid cadre of health-workers, especially those serving rural areas. Unlike previous small-scale, qualitative studies, our work has shown that informal mhealth is already happening at scale, far outstripping its formal equivalent. Policy-makers need to engage seriously with this emergent health system, and to work closely with those on the ground to address sources of inequity, without undermining existing good practice.

"I'm not a freshi": Culture shock, puberty and growing up as British-Bangladeshi girls.

Early puberty is a risk factor for adult diseases and biomedical and psychosocial research implicate growth (in height and weight) and stress as modifiable drivers of early puberty. Seldom have studies examined these drivers simultaneously or concurrently using quantitative and qualitative methods. Within the context of migration, we used mixed-methods to compare growth, stress and puberty in a study of 488 girls, aged 5-16, who were either Bangladeshi, first-generation migrant to the UK, second-generation migrant, or white British (conducted between 2009 and 2011). Using a biocultural framework, we asked the questions: 1) Does migration accelerate pubertal processes? 2) What biocultural markers are associated with migration? 3) What biocultural markers are associated with puberty? Girls self-reported pubertal stage, recalled 24-h dietary intake, and answered questions relating to dress, food, and ethnic identity. We collected anthropometrics and assayed saliva specimens for dehydroepiandrosterone-sulfate (DHEA-S) to assess adrenarcheal status. Our findings demonstrate that first-generation migrants had earlier puberty than second-generation migrants and Bangladeshi girls. British style of dress did not increase with migration, while dietary choices did, which were reflected in increasing body mass index. However, the widely-used phrase, "I'm proud of my religion, but not my culture" demonstrated that ethnic identity was aligned more with Islamic religion than 'Bangladeshi culture.' This was epitomized by wearing the hijab, but denial of eating rice. The social correlates of puberty, such as 'practicing' wearing the hijab and becoming 'dedicated to the scarf,' occurred at the same ages as adrenarche and menarche, respectively, among first-generation girls. We suggest that the rejection of 'Bangladeshi culture' might be a source of psychosocial stress for first-generation girls, and this may explain elevated DHEA-S levels and early puberty compared to their second-generation counterparts. Our results support a biocultural model of adolescence, a period for biological embedding of culture, when biological and psychosocial factors adjust developmental timing with potential positive and negative implications for long-term health.

Power, danger, and secrecy-A socio-cultural examination of menstrual waste management in urban Malawi.

Menstrual blood is not just a physical substance; it is laden with symbolism and often powerfully stigmatised. It is important to understand local perceptions and attitudes towards menstrual blood, as well as the preferred practices of menstruating women, in order to design appropriate sanitation and solid waste systems to support menstruation. Failure to take account of socio-cultural factors can jeopardise the effectiveness of such infrastructure. This study, conducted in Blantyre, Malawi, is a qualitative socio-cultural examination of how women manage and view menstruation. Thirty nine interviews, conducted with individuals and with small groups of friends, were carried out with thirty one women using pit latrines, flush toilets, and urine-diverting dry toilets in early 2019. Menstruation in Blantyre was found to be shrouded in secrecy because it was viewed as 'dirty', and therefore remained concealed. There was widespread anxiety about menstrual blood being used in ufiti (witchcraft), which affected how women used and disposed of their menstrual absorbents. At the same time, menstrual blood was also viewed as a powerful healing substance with uses in traditional medicine. The type of infrastructure required by women to support their menstruation depended on the type of menstrual absorbent used. Those using reusable cloth generally preferred a private bathroom with discreet drainage, whilst those using disposable pads needed a discreet and convenient disposal system. Increased preference for disposable pads over reusable cloth (particularly for younger women in education or employment) suggested that menstrual waste profiles of urban areas may be changing. Understanding these changing needs will be crucial for planning effective, sustainable waste disposal and sanitation infrastructure.

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.

SNIFF AND TELL: THE FEASIBILITY OF USING BIO-DETECTION DOGS AS A MOBILE DIAGNOSTIC INTERVENTION FOR ASYMPTOMATIC MALARIA IN SUB-SAHARAN AFRICA.

Bio-Detection Dogs (BDDs) are used in some high-income countries as a diagnostic intervention, yet little is known about their potential in low/middle-income countries with limited diagnostic resources. This exploratory study investigated the opportunities and implications of deploying BDDs as a mobile diagnostic intervention to identify people with asymptomatic malaria, particularly at ports of entry, as an important step to malaria elimination in a population. A qualitative study design consisting of participant observation, five focus group discussions and informal conversations was employed in The Gambia in April-May 2017. A disciplined German Shepherd companion dog (not trained as a BDD) was introduced to research participants and their perceptions recorded. Field-notes and discussions were transcribed, translated and analysed thematically. Most research participants viewed positively the possibility of using BDDs to detect malaria, with the major advantage of being non-invasive. Some concerns, however, were raised regarding safety and efficacy, as well as cultural issues around the place of dogs within human society. The Gambia is a rabies-endemic country, and unfamiliar dogs are not usually approached, with implications for how research participants perceived BDDs. Understanding such concerns and working with local people to address such issues must be part of any successful strategy to deploy BDDs in new settings. Bio-Detection Dogs represent a potentially non-invasive diagnostic tool for the detection of asymptomatic or chronic malaria infections, particularly in areas with very low parasite rates. However, it is important to understand local concerns and work closely with communities to address those concerns. Wider deployment of BDDs will also require careful planning and sustained financial support.

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.