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

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

Mechanisms of action and outcomes for students in Recovery Colleges

Objective\ud Recovery Colleges are widespread, with little empirical research on how they work and outcomes they produce. This study aimed to co-produce a change model characterising mechanisms of action and outcomes for mental health service users attending as students at a Recovery College.\ud Methods\ud A systematised review identified all Recovery College publications. Inductive collaborative data analysis by academic researchers and co-researchers with lived experience of ten key papers informed a theoretical framework for mechanisms and outcome for students, which was refined through deductive analysis of 34 further publications. A change model was co-produced and then refined through stakeholder interviews (n=33).\ud Results\ud Three mechanisms of action for Recovery College students were identified: empowering environment (safety, respect, supporting choices), enabling different relationships (power, peers, working together) and facilitating personal growth (e.g. co-produced learning, strengths, celebrating success). Outcomes were change in the student (e.g. self-understanding, self-confidence) and changes in the student’s life (e.g. occupational, social, service use). A co-produced change model mapping mechanisms of action to outcomes was created.\ud Conclusions\ud The key features identified as differentiating Recovery Colleges from traditional services are an empowering environment, enabling relationships and growth orientation. Recovery Colleges may benefit most attenders, but mental health service users to particularly encourage to enrol may include those who lack confidence, those who services struggle to engage with, those who will benefit from exposure to peer role models, and those lacking social capital. The change model provides the first testable characterisation of mechanisms and outcomes, allowing formal evaluation of Recovery Colleges

Enhancing Digital Capacity in Teaching and Learning in Irish Universities

The IUA-led project, Enhancing Digital Capacity in Teaching and Learning in Irish Universities, is a 3-year project involving all seven Irish universities. The aim is to enhance the digital attributes and educational experiences of Irish university students through enabling the mainstreamed and integrated use of digital technologies across the teaching and learning process. To achieve this, the project focuses on the professional development of all staff who teach or support learning. The project started in January 2019 and will run until the end of 2021. This paper describes the organisation of the project, which brings together academic leaders in each of the universities to provide oversight, as well as a project team with members embedded in each university context. The project activities in the first year are described, including the collection of data related to CPD opportunities to provide a baseline, and the launch of seven pilots across the university sector

Mechanisms of action and outcomes for students in Recovery Colleges

Objective Recovery Colleges are widespread, with little empirical research on how they work and outcomes they produce. This study aimed to co-produce a change model characterising mechanisms of action and outcomes for mental health service users attending as students at a Recovery College. Methods A systematised review identified all Recovery College publications. Inductive collaborative data analysis by academic researchers and co-researchers with lived experience of ten key papers informed a theoretical framework for mechanisms and outcome for students, which was refined through deductive analysis of 34 further publications. A change model was co-produced and then refined through stakeholder interviews (n=33). Results Three mechanisms of action for Recovery College students were identified: empowering environment (safety, respect, supporting choices), enabling different relationships (power, peers, working together) and facilitating personal growth (e.g. co-produced learning, strengths, celebrating success). Outcomes were change in the student (e.g. self-understanding, self-confidence) and changes in the student’s life (e.g. occupational, social, service use). A co-produced change model mapping mechanisms of action to outcomes was created. Conclusions The key features identified as differentiating Recovery Colleges from traditional services are an empowering environment, enabling relationships and growth orientation. Recovery Colleges may benefit most attenders, but mental health service users to particularly encourage to enrol may include those who lack confidence, those who services struggle to engage with, those who will benefit from exposure to peer role models, and those lacking social capital. The change model provides the first testable characterisation of mechanisms and outcomes, allowing formal evaluation of Recovery Colleges

Mechanisms of action and outcomes for students in Recovery Colleges

Objective Recovery Colleges are widespread, with little empirical research on how they work and outcomes they produce. This study aimed to co-produce a change model characterising mechanisms of action and outcomes for mental health service users attending as students at a Recovery College. Methods A systematised review identified all Recovery College publications. Inductive collaborative data analysis by academic researchers and co-researchers with lived experience of ten key papers informed a theoretical framework for mechanisms and outcome for students, which was refined through deductive analysis of 34 further publications. A change model was co-produced and then refined through stakeholder interviews (n=33). Results Three mechanisms of action for Recovery College students were identified: empowering environment (safety, respect, supporting choices), enabling different relationships (power, peers, working together) and facilitating personal growth (e.g. co-produced learning, strengths, celebrating success). Outcomes were change in the student (e.g. self-understanding, self-confidence) and changes in the student’s life (e.g. occupational, social, service use). A co-produced change model mapping mechanisms of action to outcomes was created. Conclusions The key features identified as differentiating Recovery Colleges from traditional services are an empowering environment, enabling relationships and growth orientation. Recovery Colleges may benefit most attenders, but mental health service users to particularly encourage to enrol may include those who lack confidence, those who services struggle to engage with, those who will benefit from exposure to peer role models, and those lacking social capital. The change model provides the first testable characterisation of mechanisms and outcomes, allowing formal evaluation of Recovery Colleges

The Transient Receptor Potential Ion Channel TRPV6 Is Expressed at Low Levels in Osteoblasts and Has Little Role in Osteoblast Calcium Uptake

Background: TRPV6 ion channels are key mediators of regulated transepithelial absorption of Ca2+ within the small intestine. Trpv6-/- mice were reported to have lower bone density than wild-type littermates and significant disturbances in calcium homeostasis that suggested a role for TRPV6 in osteoblasts during bone formation and mineralization. TRPV6 and molecules related to transepithelial Ca2+ transport have been reported to be expressed at high levels in human and mouse osteoblasts. Results: Transmembrane ion currents in whole cell patch clamped SaOS-2 osteoblasts did not show sensitivity to ruthenium red, an inhibitor of TRPV5/6 ion channels, and 45Ca uptake was not significantly affected by ruthenium red in either SaOS-2 (P = 0.77) or TE-85 (P = 0.69) osteoblastic cells. In contrast, ion currents and 45Ca uptake were both significantly affected in a human bronchial epithelial cell line known to express TRPV6. TRPV6 was expressed at lower levels in osteoblastic cells than has been reported in some literature. In SaOS-2 TRPV6 mRNA was below the assay detection limit; in TE-85 TRPV6 mRNA was detected at 6.90±1.9 × 10−5 relative to B2M. In contrast, TRPV6 was detected at 7.7±3.0 × 10−2 and 2.38±0.28 × 10−4 the level of B2M in human carcinoma-derived cell lines LNCaP and CaCO-2 respectively. In murine primary calvarial osteoblasts TRPV6 was detected at 3.80±0.24 × 10−5 relative to GAPDH, in contrast with 4.3±1.5 × 10−2 relative to GAPDH in murine duodenum. By immunohistochemistry, TRPV6 was expressed mainly in myleocytic cells of the murine bone marrow and was observed only at low levels in murine osteoblasts, osteocytes or growth plate cartilage. Conclusions: TRPV6 is expressed only at low levels in osteoblasts and plays little functional role in osteoblastic calcium uptake