NOACs Added to WHO's Essential Medicines List: Recommendations for Future Policy Actions.

The introduction of non-vitamin K antagonists oral anticoagulants, a class of medicines which includes dabigatran, apixaban, edoxaban and rivaroxaban, has resulted in improvements in the safety and efficacy of non valvular atrial fibrillation treatment for stroke prevention, with significant reductions in stroke, intracranial haemorrhage, and mortality. For these reasons, a team of World Heart Federation Emerging Leaders led efforts to add non-vitamin K antagonists oral anticoagulants to the World Health Organization's Model List of Essential Medicines in 2019. Following the inclusion of this class of medicines in the Essential Medicines List, this editorial proposes several recommendations to improve the accessibility, affordability and acceptability of non-vitamin K oral anticoagulants, especially in low- and middle-income settings, in order to successfully manage non-valvular atrial fibrillation and to lower the risk of stroke.

Acceptability and feasibility of a national essential medicines list in Canada: a qualitative study of perceptions of decision-makers and policy stakeholders.

BACKGROUND: Policy approaches have been considered to address inconsistent and inequitable prescription drug coverage in Canada, including a national essential medicines list. We sought to explore key factors influencing the acceptability and feasibility of an essential medicines list in Canada. METHODS: We conducted semi-structured interviews with decision-makers and other key stakeholders from government or pan-Canadian institutions, civil society and the private sector across Canada. We analyzed data using inductive thematic analysis and by applying Kingdon's Multiple Streams Framework to analyze the emergent themes deductively. RESULTS: We conducted 21 interviews before thematic saturation was achieved. We categorized emergent themes to describe the problem, the essential medicines list policy (including content and process), and politics. There was consensus among participants that prescription drug coverage was an important problem to address. Participants differed in their views on how to define essential medicines and concerns about what would be excluded from an essential medicines list. There was consensus on important features for a process to develop an essential medicines list: an independent decision-making body, use of defined selection criteria based on quality evidence, and clear communication of the purpose of the essential medicines list. Federal government financing and the broader pharmacare model, engagement of various interest groups and changing political agendas emerged as core political factors to consider if developing a Canadian essential medicines list. INTERPRETATION: Although stakeholders' views on the content of a Canadian essential medicines list varied, there was consensus on the process to formulate and implement an essential medicines list or common national formulary, including choosing medicines based on best evidence. Greater understanding is now needed on how patients, clinicians and the public perceive the concept of an essential medicines list.

Selection of WHO-recommended essential medicines for non-communicable diseases on National Essential Medicines Lists.

BACKGROUND: Non-communicable diseases (NCDs) are the leading cause of death worldwide. Inadequate and inequitable access to essential NCD medicines is a major concern, particularly in low- and middle-income countries. National Essential Medicines Lists (EMLs) are important policy tools that indicate which medicines are prioritized as essential within a country's health system. This study sought to analyze a wide range of national essential medicines lists (EMLs) for their inclusion of priority non communicable disease (NCD) interventions recommended by the World Health Organization (WHO). METHODS: Three lists of WHO endorsed priority NCD interventions were included. A database with 137 national EMLs and the WHO EML was created from the WHO Repository and these EMLs were compared for listing of priority NCD interventions. RESULTS: Across 137 countries with national EMLs, the median percentage of 20 Best Buys interventions listed was 90% (IQR 80-95) and 31 Package of essential noncommunicable disease interventions (PEN) interventions listed was 94% (IQR 90-97), of 9 HEARTS interventions was 100% (IQR 89-100), and of the 43 unique interventions across the three priority lists was 88% (IQR 84-93). Less than 80% of the 43 interventions were listed by 22 (16%) countries and less than half of the interventions were listed by 2 countries: Angola (35%) and Cambodia (23%). Interventions listed on the fewest number of national EMLs were: influenza vaccine, HPV vaccine, hepatitis B vaccine, cervical cancer chemotherapy, codeine, promethazine, senna, and oxygen. CONCLUSION: Most NCD interventions have been prioritized in national policy in most cases. The majority of priority medicines for NCDs described within key WHO NCD technical packages are listed on nearly all national EMLs across 137 countries of all income levels. Most NCD interventions have been prioritized in national policy in most cases, but in some countries and for select interventions such as the HPV vaccine, prioritization may be reviewed.

Overcoming Obstacles To Enable Access To Medicines For Noncommunicable Diseases In Poor Countries.

The modern access-to-medicines movement grew largely out of the civil-society reaction to the HIV/AIDS pandemic three decades ago. While the movement was successful with regard to HIV/AIDS medications, the increasingly urgent challenge to address access to medicines for noncommunicable diseases has lagged behind-and, in some cases, has been forgotten. In this article we first ask what causes the access gap with respect to lifesaving essential noncommunicable disease medicines and then what can be done to close the gap. Using the example of the push for access to antiretrovirals for HIV/AIDS patients for comparison, we highlight the problems of inadequate global financing and procurement for noncommunicable disease medications, intellectual property barriers and concerns raised by the pharmaceutical industry, and challenges to building stronger civil-society organizations and a patient and humanitarian response from the bottom up to demand treatment. We provide targeted policy recommendations, specific to the public sector, the private sector, and civil society, with the goal of improving access to noncommunicable disease medications globally.

Acceptance of a malaria vaccine by caregivers of sick children in Kenya.

BACKGROUND: Several malaria vaccines are currently in clinical trials and are expected to provide an improved strategy for malaria control. Prior to introduction of a new vaccine, policymakers must consider the socio cultural environment of the region to ensure widespread community approval. This study investigated the acceptance of a malaria vaccine by child caregivers and analysed factors that influence these. METHODS: Interviews from a standard questionnaire were conducted with 2,003 caregivers at 695 randomly selected health facilities across Kenya during the Kenya Service Provision Assessment Survey 2010. Multinomial regression of quantitative data was conducted using STATA to analyse determinants of caregivers accepting malaria vaccination of their child. RESULTS: Mothers represented 90% of caregivers interviewed who brought their child to the health facility, and 77% of caregivers were 20-34 years old. Overall, 88% of respondents indicated that they would accept a malaria vaccine, both for a child in their community and their own child. Approval for a vaccine was highest in malaria-endemic Nyanza Province at 98.9%, and lowest in the seasonal transmission area of North Eastern Province at 23%. Although 94% of respondents who had attended at least some school reported they would accept the vaccine for a child, only 56% of those who had never attended school would do so. The likelihood of accepting one's own child to be immunized was correlated with province, satisfaction with health care services in the facility attended, age of the caregiver, and level of education. CONCLUSIONS: Results from this study indicate a need for targeted messages and education on a malaria vaccine, particularly for residents of regions where acceptance is low, older caregivers, and those with low literacy and school-attendance levels. This study provides critical evidence to inform policy for a new malaria vaccine that will support its timely and comprehensive uptake in Kenya.

Tyrosine kinase chromosomal translocations mediate distinct and overlapping gene regulation events.

BACKGROUND: Leukemia is a heterogeneous disease commonly associated with recurrent chromosomal translocations that involve tyrosine kinases including BCR-ABL, TEL-PDGFRB and TEL-JAK2. Most studies on the activated tyrosine kinases have focused on proximal signaling events, but little is known about gene transcription regulated by these fusions. METHODS: Oligonucleotide microarray was performed to compare mRNA changes attributable to BCR-ABL, TEL-PDGFRB and TEL-JAK2 after 1 week of activation of each fusion in Ba/F3 cell lines. Imatinib was used to control the activation of BCR-ABL and TEL-PDGFRB, and TEL-JAK2-mediated gene expression was examined 1 week after Ba/F3-TEL-JAK2 cells were switched to factor-independent conditions. RESULTS: Microarray analysis revealed between 800 to 2000 genes induced or suppressed by two-fold or greater by each tyrosine kinase, with a subset of these genes commonly induced or suppressed among the three fusions. Validation by Quantitative PCR confirmed that eight genes (Dok2, Mrvi1, Isg20, Id1, gp49b, Cxcl10, Scinderin, and collagen Vα1(Col5a1)) displayed an overlapping regulation among the three tested fusion proteins. Stat1 and Gbp1 were induced uniquely by TEL-PDGFRB. CONCLUSIONS: Our results suggest that BCR-ABL, TEL-PDGFRB and TEL-JAK2 regulate distinct and overlapping gene transcription profiles. Many of the genes identified are known to be involved in processes associated with leukemogenesis, including cell migration, proliferation and differentiation. This study offers the basis for further work that could lead to an understanding of the specificity of diseases caused by these three chromosomal translocations.