Study protocol for a cluster-randomized controlled trial of an NCD access to medicines initative: Evaluation of Novartis Access in Kenya

INTRODUCTION: Novartis recently launched Novartis Access, an initiative to provide a basket of reduced price medicines for non-communicable diseases (NCDs) to be sold through the public and private nonprofit sectors in programme countries. This study will evaluate the impact of Novartis Access on the availability and price of NCD medicines at health facilities and households in Kenya, the first country to receive the programme. METHODS: This study will be a cluster randomised controlled trial. 8 counties in Kenya will be randomly assigned to the intervention or control group using a covariate constrained randomisation method to maximise balance on demographic and health characteristics. In intervention counties, public and private non-profit health facilities will be able to order Novartis Access NCD medicines from the Mission for Essential Drugs and Supplies (MEDS). Data will be collected from a random sample of 384 health facilities and 800 households at baseline, midline after 1-year of intervention, and end-line after 2 years. Quarterly surveillance data will also be collected from health facilities and a subsample of households through phone-based interviews. Households will be eligible if at least one resident has been previously diagnosed and prescribed a medicine for an NCD addressed by Novartis Access, including hypertension and diabetes. The primary outcomes will be availability and price of NCD medicines at health facilities, and availability, price, and expenditures on NCD medicines at households. Impacts will be estimated using intention-to-treat analysis. ETHICS AND DISSEMINATION: This protocol was approved by the Institutional Review Boards at Strathmore University and at Boston University. Informed consent will be obtained from all participants at the start of the trial. The findings of the trial will be disseminated through peer-reviewed journals, international conferences, and meetings and events organised with local stakeholders

Access to medicines from a health system perspective

Most health system strengthening interventions ignore interconnections between systems components. In particular, complex relationships between medicines and health financing, human resources, health information and service delivery are not given sufficient consideration. As a consequence, populations' access to medicines (ATM) is addressed mainly through fragmented, often vertical approaches usually focusing on supply, unrelated to the wider issue of access to health services and interventions. The objective of this article is to embed ATM in a health system perspective. For this purpose, we perform a structured literature review: we examine existing ATM frameworks, review determinants of ATM and define at which level of the health system they are likely to occur; we analyse to which extent existing ATM frameworks take into account access constraints at different levels of the health system. Our findings suggest that ATM barriers are complex and interconnected as they occur at multiple levels of the health system. Existing ATM frameworks only partially address the full range of ATM barriers. We propose three essential paradigm shifts that take into account complex and dynamic relationships between medicines and other components of the health system. A holistic view of demand-side constraints in tandem with consideration of multiple and dynamic relationships between medicines and other health system resources should be applied; it should be recognized that determinants of ATM are rooted in national, regional and international contexts. These are schematized in a new framework proposing a health system perspective on AT

Comparative assessment of medicine procurement prices in the United Nations Relief and Works Agency for Palestine Refugees in the Near East (UNRWA)

Objectives: The United Nations Relief and Works Agency for Palestine Refugees in the Near East (UNRWA), the main primary healthcare provider for 4.9 million Palestinian refugees, spent USD18.3 million on essential medicines dispensed free-of-charge through clinics in five areas of operation (‘fields’): Gaza, Jordan, Lebanon, Syria, and the West Bank (2010). Faced with budget contraints and an increasing demand for medicines to treat chronic conditions, the objective of our study was to assess UNRWA’s medicine procurement prices to see if savings could be possible. Methods: In July 2011, data was collected from UNRWA headquarters in Jordan. Price analyses focused on the top 80 medicines by value, accounting for 93% of pharmaceutical expenditure from the General Fund, with comparisons to international, regional and national references. Prices were also compared for the few medicines procured both through UNRWA’s central tender (centrally) and by the fields directly (locally). Results: Central procurement prices did not differ markedly from reference prices: median ratios of UNRWA prices to Management Sciences for Health’s International Drug Price Indicator Guide, Jordan’s Joint Procurement Department, Gulf Cooperation Council, and IDA Foundation bulk packs were 0.99, 1.00, 0.98 and 1.12 respectively. Applying the lowest comparator price to five comparatively higher priced medicines would yield savings of USD1.4 million. Local procurements were generally less cost-effective than central tender procurement, with notable differences across fields and medicines. Conclusions: Overall, UNRWA’s procurement prices were competitive despite the relatively small quantities procured. Regular monitoring of procurement prices and quantities is needed in order to make informed decisions. Our evaluation also underscores the heavy burden of antidiabetic medicines and antimicrobials on UNRWA procurement expenditure

Built heritage modelling and visualisation: the potential to engage with issues of heritage value and wider participation.

Modelling and visualisation of the built heritage is an area where the use of digital tools and techniques have become pervasive. This extends across all stages and aspects of heritage projects, and has come to include the culture of data pertaining to physical objects and environments, the subsequent uses to which that data may be put, and the manner in which stakeholder groups engage in debate, discussion and participatory decision-making. This paper provides a critical discussion of the implications of these developments and the associated technologies, and argues that what might appear to be ‘stages’ of a project should be regarded as a cycle, which embeds social and qualitative aspects of the built heritage as key components. The paper aims to contribute to the debate regarding how we can embrace developing technologies within heritage study, and how application of the technology can help to foster deeper engagement in heritage, and across society

How to save a theatre: The Orpheum, Vancouver.

Purpose: The purpose of this paper is to concern the Orpheum Theatre in Vancouver, which survived the threat of major internal demolition and rebuilding during the 1960s and early 1970s. The building has subsequently undergone significant restoration and conservation work, including the incorporation of modern acoustic improvements and the construction of a new entrance area. Understanding the mechanisms through which the building was restored and brought back into use formed a central strand of the work. Design/methodology/approach: The paper employed a single case study approach, and used the Orpheum Theatre to simultaneously study and consider the practical and heritage implications of the restoration project. The methods employed included archival study, on site recording and a study of the social and architectural history of the building. Findings: The manner in which the building was restored was unusual and rooted in the community, and holds resonance for many similarly at risk theatres and cinemas, in both Canada and elsewhere. Practical implications: The paper is interesting both from the perspective of that refurbishment, and also from the fact that it was designed by a prominent Scottish architect, B. Marcus Priteca, who designed a large number of early movie palaces in Canada and the USA. Originality/value: Through exploration of the processes involved in saving the building, the paper draws conclusions regarding its importance to the continued vibrancy of the city. The incorporation of social as well as technical information within building conservation also holds resonance within building conservation practice and planning. © Emerald Group Publishing Limited

National medicines policies – a review of the evolution and development processes

OBJECTIVES: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs. METHODS: The number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa. RESULTS: The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5–10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring. CONCLUSIONS: To date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved

Quantitative Proteomics of Cerebrospinal Fluid in Paediatric Pneumococcal Meningitis

Streptococcus pneumoniae is responsible for diseases causing major global public health problems, including meningitis, pneumonia and septicaemia. Despite recent advances in antimicrobial therapy, pneumococcal meningitis remains a life-threatening disease. Furthermore, long-term sequelae are a major concern for survivors. Hence, a better understanding of the processes occurring in the central nervous system is crucial to the development of more effective management strategies. We used mass spectrometry based quantitative proteomics to identify protein changes in cerebrospinal fluid from children with Streptococcus pneumoniae infection, compared with children admitted to hospital with bacterial meningitis symptoms but negative diagnosis. Samples were analysed, by label free proteomics, in two independent cohorts (cohort 1: cases (n = 8) and hospital controls (n = 4); cohort 2: cases (n = 8), hospital controls (n = 8)). Over 200 human proteins were differentially expressed in each cohort, of which 65% were common to both. Proteins involved in the immune response and exosome signalling were significantly enriched in the infected samples. For a subset of proteins derived from the proteome analysis, we corroborated the proteomics data in a third cohort (hospital controls (n = 15), healthy controls (n = 5), cases (n = 20)) by automated quantitative western blotting, with excellent agreement with our proteomics findings. Proteomics data are available via ProteomeXchange with identifier PXD004219

Racial Differences in Cortical Bone Mass, Size and Estimated Strength at the Tibial Diaphysis in Early Pubertal Children

poster abstractOsteoporotic fracture rates differ according to race, with blacks having up to half the rate of whites. The reduced fracture rate in blacks has been suggested to be due to their superior bone mass; however, mass is not the sole determinant of bone strength. Bone strength, and consequent fracture risk, is also influenced by how bone material is distributed or structured. It is likely bone structure also contributes to the lower incidence of fractures in blacks and that racial differences in bone structure have roots in childhood. The aim of this study was to assess the influence of race on pQCT-derived cortical bone mass, size and estimated strength at the tibial diaphysis in early pubertal children. 160 children were recruited, with equal subjects according to race (black, n=80; white, n=80) and sex (female, n=80; male, n=80). Subjects were at sexual maturation stages 2 or 3. Tomographic slices of the tibial diaphysis at 66% proximal from the medial malleolus were acquired using pQCT. Slices were assessed for cortical volumetric BMD (Ct.vBMD), cortical BMC (Ct.BMC), total (Tt.Ar) and cortical (Ct.Ar) area, density weighted maximum (IMAX) and minimum (IMIN) second moments of area, density-weighted polar strength-strain index (SSIP), and muscle cross-sectional area (mCSA). Group differences were assessed by two-way analysis of covariance, with race (black vs. white) and sex (female vs. male) as independent variables. Covariates included predicted years from peak height velocity (maturity offset), tibial length and mCSA. There were no interactions between race and sex (all P=0.50-0.98) or main effect for sex (all P=0.08-0.45). Blacks had 15.7% more Ct.BMC, and 10.8-11.8% larger Tt.Ar and Ct.Ar than whites (all P<0.001). The greater enhancement of Ct.BMC relative to Ct.Ar resulted in blacks having 3.6% greater Ct.vBMD than whites (P<0.001). The combination of increased cortical bone mass, size and density in blacks contributed to enhanced estimated bone strength, with IMAX, IMIN and SSIP being 20.0%, 34.5% and 25.2% greater in blacks than whites, respectively (all P<0.001). These data indicate that early pubertal black children have enhanced bone mass, size and estimated bone strength at the tibial diaphysis versus whites, independent of tibial length and mCSA. They suggest bone structural differences may contribute to observed racial differences in fracture rates and that structural divergence between races develops during childhood