Evolving assessment pathways for precision oncology medicines to improve patient access: a tumor-agnostic lens.

BACKGROUND: Genomic and molecular alterations are increasingly important in cancer diagnosis, and scientific advances are opening new treatment avenues. Precision oncology (PO) uses a patient's genomic profile to determine optimal treatment, promising fewer side effects and higher success rates. Within PO, tumor-agnostic (TA) therapies target genomic alterations irrespective of tumor location. However, traditional value frameworks and approval pathways pose challenges which may limit patient access to PO therapies. OBJECTIVES: This study describes challenges in assessing PO and TA medicines, explores possible solutions, and provides actionable recommendations to facilitate an iterative life-cycle assessment of these medicines. METHODS: After reviewing the published literature, we obtained insights from key stakeholders and European experts across a range of disciplines, through individual interviews and an industry workshop. The research was guided and refined by an international expert committee through 2 sounding board meetings. RESULTS: The current challenges faced by PO and TA medicines are multiple and can be demonstrated through real-world examples of the current barriers and opportunities. A life-cycle approach to assessment should be taken, including key actions at the early stages of evidence generation, regulatory and reimbursement stage, as well as payment and adoption solutions that make use of the evolving evidence base. Working toward these solutions to maximize PO medicine value is a shared responsibility and stands to benefit all stakeholders. CONCLUSIONS: Our call to action is to expand access to comprehensive genomic testing, foster a learning health care system, enable fast and equitable access to cost-effective treatments, and ultimately improve health outcomes.

[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain.

OBJECTIVE: To analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. METHODS: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. RESULTS: During the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. CONCLUSIONS: Drugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them.

Access to essential medicines for diabetes care: availability, price, and affordability in central Ethiopia.

BACKGROUND: Diabetes is a major global public health burden. Effective diabetes management is highly dependent on the availability of affordable and quality-assured essential medicines (EMs) which is a challenge especially in low-and-middle-income countries such as Ethiopia. This study aimed to assess the accessibility of EMs used for diabetes care in central Ethiopia's public and private medicine outlets with respect to availability and affordability parameters. METHODS: A cross-sectional study was conducted in 60 selected public and private medicine outlets in central Ethiopia from January to February 2022 using the World Health Organization/Health Action International (WHO/HAI) standard tool to assess access to EMs. We included EMs that lower glucose, blood pressure, and cholesterol as these are all critical for diabetes care. Availability was determined as the percentage of surveyed outlets per sector in which the selected lowest-priced generic (LPG) and originator brand (OB) products were found. The number of days' wages required by the lowest paid government worker (LPGW) to purchase a one month's supply of medicines was used to measure affordability while median price was determined to assess patient price and price markup difference between public procurement and retail prices. RESULTS: Across all facilities, availability of LPG and OB medicines were 34.6% and 2.5% respectively. Only two glucose-lowering (glibenclamide 5 mg and metformin 500 mg) and two blood pressure-lowering medications (nifedipine 20 mg and hydrochlorothiazide 25 mg) surpassed the WHO's target of 80% availability. The median price based on the least measurable unit of LPG diabetes EMs was 1.6 ETB (0.033 USD) in public and 4.65 ETB (0.095 USD) in private outlets. The cost of one month's supply of diabetes EMs was equivalent to 0.3 to 3.1 days wages in public and 1.0 to 11.0 days wages in private outlets, respectively, for a typical LPGW. Thus, 58.8% and 84.6% of LPG diabetes EMs included in the price analysis were unaffordable in private and public outlets, respectively. CONCLUSIONS: There are big gaps in availability and affordability of EMs used for diabetes in central Ethiopia. Policy makers should work to improve access to diabetes EMs. It is recommended to increase government attention to availing affordable EMs for diabetes care including at the primary healthcare levels which are more accessible to the majority of the population. Similar studies are also recommended to be conducted in different parts of Ethiopia.

Long-COVID Prevalence and Its Association with Health Outcomes in the Post-Vaccine and Antiviral-Availability Era.

Background and Objectives: After recovering from COVID-19, patients may experience persistent symptoms, known as post-COVID-19 syndrome or long COVID, which include a range of continuing health problems. This research explores the prevalence, associated factors, and overall health outcomes of long COVID during a period of extensive vaccination and antiviral treatment availability in Thailand. Materials and Methods: This observational study involved 390 adult patients with COVID-19 between January and March 2022. Beginning three months after their diagnosis, these patients were interviewed via telephone every three months for a period of one year. The data collection process included gathering demographic information and administering a standardized questionnaire that addressed the patients' physical condition following COVID-19, their mental health, sleep disturbances, and overall quality of life. Results: The cohort consisted of 390 participants, with an average age of 31.8 ± 13.6. Among them, 96.7% (n = 377) were vaccinated, and 98.2% (n = 383) underwent antiviral treatment. Long-COVID prevalence was observed at 77.7%, with the most frequently reported symptoms being fatigue (64.1%) and cough (43.9%). Regarding mental health, depression was reported by 8.2% of the participants, anxiety by 4.1%, and poor sleep quality by 33.3%. Advanced statistical analysis using multivariable logistic regression showed significant links between long-COVID symptoms and patients aged below 60 (p = 0.042), as well as the initial symptom of cough (p = 0.045). In the subset of long-COVID sufferers, there was a notable correlation in females with symptoms such as headaches (p = 0.001), dizziness (p = 0.007), and brain fog (p = 0.013). Conclusions: Despite the extensive distribution of vaccines and antiviral therapies, the prevalence of long COVID remains high, being associated particularly with individuals under 60 and those exhibiting a cough as an early symptom. The study further reveals that mental health issues related to long COVID are profound, going beyond the scope of physical symptomatology.

A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication.

BACKGROUND: Although statins reduce adverse cardiovascular outcomes, less than half of eligible patients receive treatment. A nonprescription statin has the potential to improve access to statins. OBJECTIVES: To assess concordance between clinician and consumer assessment of eligibility for nonprescription statin treatment using a Technology Assisted Self-Selection (TASS) Web Application (Web App) and evaluate effect on low-density lipoprotein cholesterol (LDL-C) levels. METHODS: A prospective actual use 6-month study to evaluate use of a Web App to qualify participants without a medical background for a moderate intensity statin based on current guidelines. Participants entered demographic information, cholesterol values, blood pressure and concomitant medications into the Web App, resulting in three possible outcomes- "Do Not Use," "Ask a Doctor" or "OK to Use". RESULTS: The study included 1196 participants, median age 63 (IQR, 57-68), 39.6% women, 79.3% White, 11.7% Black, and 4.1% with limited literacy. Mean LDL-C was 139.6 mg/dL (SD, 28.3) and median calculated 10-year risk of atherosclerotic cardiovascular disease was 10.1% (IQR, 7.3-14.0). Initial Web App self-selection resulted in an outcome concordant with clinician assessment in 90.7% (95% CI, 88.9-92.3) of participants and 98.1% (95% CI, 97.1-98.8) had a concordant final use outcome during treatment. Mean percent change in LDL-C was -35.5% (95% CI, -36.6 to -34.3). Serious adverse events occurred in 27 (2.3%) participants, none related to study drug. CONCLUSIONS: In this actual use study, a technology assisted Web App allowed >90% of consumers to correctly self-select for statin use and achieve clinically important LDL-C reductions.

Progress in Access and Oral Polio Vaccine Coverage Among Children Aged <5 Years in Polio Campaigns After the Political Change in Afghanistan.

BACKGROUND: Warfare has long impeded vaccination programs in polio-endemic Afghanistan. We aimed to describe progress in access to children under 5, oral polio vaccine (OPV) coverage among children under 5 in nationwide polio campaigns, and polio surveillance performance indicators after the Islamic Republic of Afghanistan collapsed to Taliban forces in August 2021. METHODS: Trends in the number of wild poliovirus type 1 (WPV1) and circulating vaccine-derived poliovirus type 2 (cVDPV2) cases and surveillance indicators from 2015 to 2023, and trends in the OPV coverage in the November 2020-June 2022 polio campaigns, were described. RESULTS: From 2015 to mid-July 2020, 74 of 126 (58.7%) WPV1 cases were reported from inaccessible areas. In November 2020, 34.1% of target children under 5 were inaccessible; in November 2021 (the first postchange polio campaign), all were accessible. From November 2020, under-5 OPV coverage of 69.9% rose steadily to 99.9% in the May 2022 campaign. The number of cVDPV cases fell from 308 (2020) to zero (2022). June 2022's house-to-house OPV coverage was 34.2% higher than non-house-to-house modalities. Nonpolio acute flaccid paralysis and stool adequacy rates rose from 18.5/100 000 and 92.6% in 2020 to 24.3/100 000 and 94.4% in 2022, respectively. CONCLUSIONS: Children's inaccessibility no longer vitiates polio eradication; polio surveillance systems are less likely to miss any poliovirus circulation.

Society for Maternal-Fetal Medicine Position Statement: Access to abortion care.

The Society for Maternal-Fetal Medicine (SMFM) supports the right of all individuals to access the full spectrum of reproductive health services, including abortion care. Reproductive health decisions are best made by each individual with guidance and support from their healthcare providers.

Vaccine Elicited Antibodies Restrict Glucose Availability to Control Brucella Infection.

The impact of vaccine-induced immune responses on host metabolite availability has not been well studied. Here we show prior vaccination alters the metabolic profile of mice challenged with Brucella melitensis. In particular, glucose levels were reduced in vaccinated mice in an antibody-dependent manner. We also found the glucose transporter gene, gluP, plays a lesser role in B. melitensis virulence in vaccinated wild-type mice relative to vaccinated mice unable to secrete antibodies. These data indicate vaccine-elicited antibodies protect the host in part by restricting glucose availability. Moreover, Brucella and other pathogens may need to employ different metabolic strategies in vaccinated hosts.

Expanding access to healthcare for people who use drugs and sex workers: hepatitis C elimination implications from a qualitative study of healthcare experiences in British Columbia, Canada.

BACKGROUND: Hepatitis C virus (HCV) is a major health threat in Canada. In British Columbia (BC) province, 1.6% of the population had been exposed to HCV by 2012. Prevalence and incidence of HCV are very high in populations of people who use drugs (PWUD) and sex workers (SW), who may experience unique barriers to healthcare. Consequently, they are less likely to be treated for HCV. Overcoming these barriers is critical for HCV elimination. This research sought to explore the healthcare experiences of PWUD and SW and how these experiences impact their willingness to engage in healthcare in the future, including HCV care. METHODS: Interpretive Description guided this qualitative study of healthcare experiences in BC, underpinned by the Health Stigma and Discrimination framework. The study team included people with living/lived experience of drug use, sex work, and HCV. Twenty-five participants completed in-depth semi-structured interviews on their previous healthcare and HCV-related experiences. Thematic analysis was used to identify common themes. RESULTS: Three major themes were identified in our analysis. First, participants reported common experiences of delay and refusal of care by healthcare providers, with many negative healthcare encounters perceived as rooted in institutional culture reflecting societal stigma. Second, participants discussed their choice to engage in or avoid healthcare. Many avoided all but emergency care following negative experiences in any kind of healthcare. Third, participants described the roles of respect, stigma, dignity, fear, and trust in communication in healthcare relationships. CONCLUSIONS: Healthcare experiences shared by participants pointed to ways that better understanding and communication by healthcare providers could support positive change in healthcare encounters of PWUD and SW, who are at high risk of HCV infection. More positive healthcare encounters could lead to increased healthcare engagement which is essential for HCV elimination.

Foundations of Emergency Medicine: Impact of a Standardized, Open-access, Core Content Curriculum on In-Training Exam Scores.

Introduction: Learners frequently benefit from modalities such as small-group, case-based teaching and interactive didactic experiences rather than passive learning methods. These contemporary techniques are features of Foundations of Emergency Medicine (FoEM) curricula, and particularly the Foundations I (F1) course, which targets first-year resident (PGY-1) learners. The American Board of Emergency Medicine administers the in-training exam (ITE) that provides an annual assessment of EM-specific medical knowledge. We sought to assess the effect of F1 implementation on ITE scores. Methods: We retrospectively analyzed data from interns at four EM residency programs accredited by the Accreditation Council for Graduate Medical Education. We collected data in 2021. Participating sites were geographically diverse and included three- and four-year training formats. We collected data from interns two years before (control group) and two years after (intervention group) implementation of F1 at each site. Year of F1 implementation ranged from 2015-2018 at participating sites. We abstracted data using a standard form including program, ITE raw score, year of ITE administration, US Medical Licensing Exam Step 1 score, Step 2 Clinical Knowledge (CK) score, and gender. We performed univariable and multivariable linear regression to explore differences between intervention and control groups. Results: We collected data for 180 PGY-1s. Step 1 and Step 2 CK scores were significant predictors of ITE in univariable analyses (both with P < 0.001). After accounting for Step 1 and Step 2 CK scores, we did not find F1 implementation to be a significant predictor of ITE score, P = 0.83. Conclusion: Implementation of F1 curricula did not show significant changes in performance on the ITE after controlling for important variables.

Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

Cambodia has experienced exponential economic growth in recent years and is expected to graduate from least developed country (LDC) status within the next decade. Membership of the World Trade Organization (WTO) will require Cambodia to grant product and process patents for pharmaceuticals upon LDC graduation. This study aims to measure the impact of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the price of HIV and hepatitis C medicine in Cambodia once it graduates from LDC status and is obliged to make patents available for pharmaceutical products and processes. Using scenarios based on likely outcomes of accession to the TRIPS Agreement, it measures the impact on the price of the HIV treatment program and compares that impact with the hepatitis C treatment program. Graduation from LDC status would be expected to result in a modest increase in the cost of the antiretroviral (ARV) treatment program and very large increases in the cost of the direct acting antivirals (DAA) treatment program. If annual treatment budgets remain constant, patent protection could see 1,515 fewer people living with HIV able to access ARV treatment and 2,577 fewer people able to access DAA treatment (a drop in treatment coverage of 93%).

Mapping a Way to Displaced Persons' Access to Quality Medicines.

Reliable, adequate supply of essential items, including quality-assured medicines, is hard to maintain in refugee camps in low- and middle-income countries. Disruption of medicine supply chains delays treatment for displaced persons and drives procurement of poor-quality products, often from unauthorized or unlicensed sellers. This article explains how current strategies and policies disrupt reliable flow of safe medicines to refugee camps and calls on stakeholders to rigorously map medicine supply chains to refugee camps, which would help identify strategies to improve displaced persons' access to quality-assured medicines.

Factors Influencing Compliance With Social Distancing as a Nonpharmaceutical Intervention Before Vaccine Availability During the COVID-19 Pandemic: A Cross-Sectional Study in South Korea.

This study aimed to identify factors influencing compliance with social distancing, a key nonpharmaceutical intervention during the early stages of the coronavirus disease (COVID-19) pandemic. The study population comprised 182 758 Koreans who participated in the 2020 Community Health Survey. Personal characteristics were classified into sociodemographic, health behavioral, and psychosocial factors, and factors associated with social distancing compliance were identified. Health behaviors and psychosocial factors were highly related to compliance with social distancing. Approximately 13% of smokers were less likely to practice physical distancing and 50% of high-risk drinkers were less likely to limit going out or attending gatherings and events. Higher concern about COVID-19 and a more positive perception of the government's response policy were associated with a higher compliance with social distancing. Strategic public health policies considering the characteristics of the public are needed to enhance compliance with nonpharmaceutical interventions during disease outbreaks lacking effective treatments and vaccines.

Availability and Affordability of Essential Palliative Care Medicines in Nepal: A cross-sectional study.

CONTEXT: The government of Nepal adopted 2017 Nepalese National Strategy for Palliative Care (NSPC), which proposed that Essential Palliative Care Medicines (EPCMs) listed by International Association for Hospice and Palliative Care (IAHPC) should be available at each healthcare institution. In 2017 after the issuing of NSPC, the Lancet Commission developed an EPCM list. OBJECTIVE: To evaluate the inclusion of EPCMs recommended by both IAHPC and Lancet in national medicinal programmes, their availability and affordability in Nepal. METHOD: A cross-sectional descriptive study of availability of EPCMs in Nepal, their inclusion in National Essential Medicines List (NEML), Government Health Insurance Medicines List (GHIML), Government Fixed Rate Medicines List (GFRML) and free medicines list. Affordability was assessed using the WHO Daily-Define-Dose and the Nepal Government-defined minimum daily wage. RESULT: 27/33(82%) of the IAHPC-EPCMs and 41/60(68%) of the recommended formulations were available in Nepal. All the Lancet Commission recommended EPCMs were available in Nepal. Morphine was available in all formulations used in palliative care. 22%, 18% and 10% of IAHPC-EPCMs were available cost free via district hospitals, primary health centres and health posts, respectively. Government had not included opioids on both free and fixed price list. 24/33(73%) of IAHPC-EPCMs were available on the GHIML. 19/41(46%) available EPCMs were affordable. CONCLUSION: Many EPCM formulations included in NSPC of Nepal are not available, and most available EPCMs are unaffordable if purchased out-of-pocket. While the availability is better with government health insurance scheme, many people are not registered for this. Further improvements should follow the development of a Nepalese palliative care formulary.

Pandemics, intellectual property and 'our economy': A worldview analysis of Canada's role in compromising global access to COVID-19 vaccines.

Despite self-congratulatory rhetoric, Canada compromised COVID-19 vaccine equity with policies impeding a proposed global waiver of vaccine intellectual property (IP) rules. To learn from Canada's vaccine nationalism we explore the worldview - a coherent textual picture of the world - in a sample of Government of Canada communications regarding global COVID-19 vaccine sharing. Analysed documents portray risks and disparities as unrelated to the dynamics and power relations of the Canadian and international economies. Against this depoliticised backdrop, economic growth fueled by strict IP rules and free trade is advanced as the solution to inequities. Global vaccine access and distribution are pursued via a charity-focused public-private-partnership approach, with proposals to relax international IP rules dismissed as unhelpful. Rather than a puzzling lapse by a good faith 'middle power', Canada's obstruction of global COVID-19 vaccine equity is a logical and deliberate extension of dominant neoliberal economic policy models. Health sector challenges to such models must prioritise equity in global pandemic governance via politically assertive and less conciliatory stances towards national governments and multilateral organisations. Mobilisation for health equity should transform the overall health-damaging macroeconomic model, complementing efforts based on specific individual health determinants or medical technologies.

Servicios farmacéuticos basados en la atención primaria de salud: Herramienta para la evaluación de la calidad de la prestación de los servicios farmacéuticos en países de la Región de las Américas / Pharmaceutical services based on primary health care: Tool for evaluating the quality of the provision of pharmaceutical services in countries of the Region of the Americas

El presente documento ofrece una herramienta robusta que consta de 79 indicadores, basados en los principios de una atención primaria de salud renovada, y diseñados para ser implementados en los servicios farmacéuticos de la Región. En estas páginas se resume el proceso de desarrollo de estos indicadores, iniciado en el 2019 bajo la dirección y coordinación de la Organización Panamericana de la Salud, con aportes del grupo expertos en el tema, talleres regionales y una prueba piloto en Argentina y Perú en el 2022. Asimismo, se describe el enfoque simplificado de niveles de implementación, que facilita la compresión de los resultados de los indicadores y la toma de decisiones, y además, se incluyen algunos elementos clave para que los países los tengan en cuenta en el momento de implementar esta herramienta. Cada indicador se presenta en su correspondiente ficha técnica, que incluye los elementos configurativos, la clasificación según el grado de complejidad y el ámbito de los servicios farmacéuticos. Esto destaca la importancia de redefinir y evaluar la calidad de los servicios farmacéuticos en todos los niveles de atención de salud.

The availability of essential medicines in primary health centres in Indonesia: achievements and challenges across the archipelago.

Background: Indonesia is making significant strides toward achieving universal health coverage, which involves providing free access to essential medicines. This study examines the availability of essential medicine in primary health centres (PHCs) across Indonesia, the reasons why medicines are unavailable, and the extent to which communities have access to alternative dispensing points. Methods: Enumerators visited each of the 9831 PHCs in all 514 districts to assess the availability of 60 essential medicines and identify reasons for any absent medicines. We correlated the results with the national village census to assess the relationship between availability, poverty, and access to alternative dispensing points. Findings: Medicine availability varied greatly. The median availability for 17 priority medicines was 82%, while 58% of the broader selection of 60 essential medicines was present. The availability of maternal and childcare medicines was highest (73%) and lowest for mental health (42%). The main reasons for absence were that medicines were deemed unnecessary (46%) or not supplied (38%). The Java/Bali region had the highest medicines availability, and rural areas in Eastern Indonesia had the lowest. In these districts, the population is financially struggling, most dependent on free medicines from public providers, and had the least access to alternative dispensing points. Interpretation: The availability of priority medicines in PHCs is relatively high, while public-paid prices are low by international standards. To improve availability of all essential medicines, the government should prioritize areas with the highest need, increase funding for PHCs in remote areas, and implement transparent monitoring of medicines availability. Funding: Indonesian Government.

Improving Contraceptive Service Quality and Accessibility for Adolescents and Youth Through Proprietary Patent Medicine Vendors in Four Nigerian States.

INTRODUCTION: In Nigeria, health care services and commodities have increasingly been accessed through private sector entities, including retail pharmacies and drug shops (also called proprietary patent medicine vendors [PPMVs]). However, PPMVs cannot provide long-acting or permanent methods, and concerns have been raised about their quality of services and their need to better comply with government regulations. This article describes how The Challenge Initiative's (TCI) family planning program supported 4 state governments in Nigeria to develop a model to strengthen public-private partnerships between PPMVs and primary health centers (PHCs) to leverage PPMVs to provide adolescents and youth with high-quality contraceptive information, services, and referrals to PHCs. PROGRAM DESCRIPTION: The intervention implemented a hub-spoke model by strengthening the linkages between neighboring PPMVs and large PHCs for delivering contraceptive services to adolescents and youth. The steps in the implementation process included: (1) introducing the intervention to state governments, (2) selecting PPMVs as spokes and high-volume PHCs as hubs, (3) conducting whole-site orientations jointly with PPMV and PHC staff, (4) strengthening referral links between PPMVs and PHCs, (5) implementing supportive supervision and coaching, and (6) strengthening client data management. TCI worked with the state and local ministry of health to improve PPMV operators' knowledge, attitudes, and skills to deliver adolescent- and youth-friendly services. LESSONS LEARNED AND RECOMMENDATIONS: Implementing the PPMV intervention with state governments and PHCs strengthened the public-private partnership. A functional referral system in Plateau State demonstrated significant success, enabling increased contraceptive choice and adherence to regulations for adolescents and youth. We recommend that the government strengthen the working relationship between PPMVs and PHCs, incorporate PPMVs into the routine supportive supervision of the state health system, and incorporate a referral linkage with PHCs into the design and implementation of PPMV programs.