Medicine Policy Research Articles

A Conceptual Model for Health Impact Assessment of Personalized Prevention Policies

Abstract Background Personalized prevention and pharmacogenomics are emerging fields in global health, promoting tailored approaches to disease prevention and individualized drug therapy, based on the individuals’ genetic profile. However, adoption of these technologies in public health is challenged by the possibility of health disparities. Health Impact Assessment (HIA) is a useful tool to address this issue, by examining how policies differentially impact population groups, guiding stakeholders to more equitable and inclusive outcomes. Solid frameworks for assessing health impacts are needed to avoid heterogeneity when accounting for equity outcomes in HIA. This study tested a conceptual model for HIA in personalized medicine, using a case study in pharmacogenetics to map potential impacts and outcomes, with a focus on health equity. Methods A conceptual model for a HIA was developed to map expected impacts and outcomes of a health policy, aimed at enforcing DPYD genotype-guided dosing to prevent fluoropyrimidine toxicity in colorectal cancer patients. The conceptual model was developed based on literature reviews and consultation with stakeholders. Identification of relevant impacts guided selection of indicators and quantitative impact assessment using a Markov chain model. Results Impact pathways were identified using a three-tiered reference framework encompassing individual and population perspectives, organizational factors, and overarching health system considerations. The final diagram outlined key outcomes in four categories: health, organizational, economic and equity. HIA projections using this model were obtained for the DPYD testing policy. Conclusions In the rise of personalized medicine and pharmacogenomics, health inequalities challenges need to be addressed before implementation in healthcare. This study provided a novel HIA conceptual model for personalized prevention policies based on genomic information, with an emphasis on equity. Key messages • HIA is an adequate tool to evaluate potential health inequalities resulting from personalized medicine policies in healthcare. • This study provides a validated framework for HIA of personalized prevention policies grounded in genomic data.

Challenges and applications in generative AI for clinical tabular data in physiology.

Recent advancements in generative approaches in AI have opened up the prospect of synthetic tabular clinical data generation. From filling in missing values in real-world data, these approaches have now advanced to creating complex multi-tables. This review explores the development of techniques capable of synthesizing patient data and modeling multiple tables. We highlight the challenges and opportunities of these methods for analyzing patient data in physiology. Additionally, it discusses the challenges and potential of these approaches in improving clinical research, personalized medicine, and healthcare policy. The integration of these generative models into physiological settings may represent both a theoretical advancement and a practical tool that has the potential to improve mechanistic understanding and patient care. By providing a reliable source of synthetic data, these models can also help mitigate privacy concerns and facilitate large-scale data sharing.

Population aging management from the perspective of the health field of Iran and other countries: A scoping review

Population aging is one of the challenging phenomena where due to health changes and the importance of different levels of prevention, the country’s health system is most responsible for it. Therefore, it is responsible for providing responsible service and dealing with challenges and obstacles to successfully face the aging phenomenon. In this regard, the study was conducted aiming to identify inefficiencies and solutions to face the phenomenon of population aging from the perspective of the health field in Iran and other countries. The study is a domain review that was conducted by searching for specialized words in Web of Science, Scopus, PubMed, Cochrane, Mbase, and ProQuest databases and the Persian databases of the National Journals Information Bank, the Islamic Jihad Scientific Database, Irandoc, and the World of Islam Citation Database. The findings were analyzed based on 57 articles. In order to validate the findings, the opinions of five experts in the fields of health care management, social medicine, psychology, and health policy were used in the classification and completion of data. According to the findings, the challenges of the health system in facing the aging phenomenon were “inefficiencies of the health system”, “medication and treatment problems”, “costs and financing of the health system”, “inefficiencies related to health system employees”, “information and technology challenges”, “service challenges”, “health literacy and unfavorable lifestyle”, and “individual and social obstacles”, and the solutions to successfully face the aging phenomenon include “formulating laws and executive policies”, “prevention and treatment”, “supplying and developing resources”, “development of knowledge and technological performance”, “development of stakeholders’ participation”, “elderly centered”, and “social determinants of health”. The breadth and diversity of the findings indicate that the health system should be updated and strengthened in various social, economic, political, legislative, and executive dimensions in order to successfully tackle the aging phenomenon, and it should consider empowerment and attitude improvement programs of managers and health staff as well as the elderly.

Shifting from Theoretical Best Evidence to Practical Best Evidence: an Approach to Overcome Structural Conservatism of Evidence-Based Medicine and Health Policy.

There is disparity in the healthcare sector between the extent of innovation in medical products (e. g., drugs) and healthcare structures. The reason is not a lack of ideas, concepts, or (quasi-) experimental studies on structural innovations. Instead, we argue that the slow implementation of structural innovations has created this disparity partly because evidence-based medicine (EBM) instruments are well suited to evaluate product innovations but less suited to evaluate structural innovations. This article argues that the unintentional interplay between EBM, which has changed significantly over time to become primarily theoretical, on the one hand, and caution and inertia in health policy, on the other, has resulted in structural conservatism. Structural conservatism is present when healthcare structures persistently and essentially resist innovation. We interpret this phenomenon as an unintended consequence of deliberate EBM action. Therefore, we propose a new assessment framework to respond to structural innovations in healthcare, centered on the differentiation between the theoretical best (possible) evidence, the practical best (possible) evidence, and the best available evidence.

Price Control Policies for Medicines: How Far the Accessibility Is Achieved by Patients?

Price Control Policies for Medicines: How Far the Accessibility Is Achieved by Patients?

Factors affecting the essential medicine prescribing behavior among general practitioners in Beijing, China: a cross-sectional study with structural equation model

BackgroundThe aim of this study is to explore the influence of GPs’information, motivation and behavior skills on EM prescribing behavior in urban and suburban districts.MethodA cross-sectional study was conducted from June to November 2022 cross 3 urban districts and 4 suburban districts in Beijing. The structural equation model was used to analyze the factors influencing the essential medicine prescription behavior among general practitioners in urban and suburban districts.ResultsA total of 511 valid questionnaires were collected. There was a statistically significant difference in mean scores for personal motivation and behavioral skills between urban GPs and suburban GPs. For urban GPs, the path analysis revealed that the social motivation had a direct effect on the essential medicine prescribing behavior (β = 0.225, p < 0.05). In contrast, for suburban GPs, both social motivation and personal motivation had a direct effect on the essential medicine prescribing behavior, respectively (β = 0.175, p < 0.05; β = 0.193, p < 0.01).ConclusionSocial motivation of urban GPs were positively and significantly associated with essential medicine prescribing behavior. Social motivation and personal motivation of suburban GPs were positively and significantly associated with essential medicine prescribing behavior. Therefore, various corresponding policies and measures should be developed to promote the National Essential Medicines Policy in China.

Enhancing Taiwan's healthcare sustainability: A Delphi study on national medicines policy reforms

Background/purposeThe National Medicines Policy (NMP) is crucial as it sets the framework for ensuring access to affordable, high-quality medicines and promoting their rational use, which is essential for public health and the efficiency of the healthcare system. This study aims to evaluate the current state of Taiwan's NMP, identify pressing issues for improvement, and establish actionable suggestions through expert consensus to ensure the sustainable provision and use of medications. MethodsA modified two-round Delphi technique was employed. The first-round survey identified key issues and suggestions for policy improvement, while the second-round survey evaluated the feasibility and effectiveness of these suggestions. The expert panel, consisting of 50 specialists from pharmacy, medicine, public health, and the pharmaceutical industry, evaluated key issues related to the NMP's efficacy using a 4-point Likert scale. ResultsThe first-round survey identified 13 key issues in Taiwan's NMP, primarily focusing on the rational use and accessibility of medications. The second-round survey proposed 54 policy improvement suggestions for these issues, of which 20 were considered strong suggestions and 23 were moderate suggestions. The policy recommendations cover medication reimbursement, pharmacy professional services, administration, legislation, and education. ConclusionThe study highlights the urgent need for reforms in Taiwan's NMP, providing specific policy improvement suggestions to ensure high-quality medications and pharmaceutical services while supporting the sustainable operation of Taiwan's NHI system. The study underscores the significance of proactive measures to fortify healthcare sustainability in the face of evolving healthcare landscapes.

A conceptual framework to build effective medicine pricing policies for low and middle-income countries (LMICs)

Building effective medicine pricing policies is a challenging task in all high-, middle- and low-income countries. In high-income countries have stable health systems in place, trained workforce, as well as specialised agencies to evaluate innovative drugs for reimbursement. However, in low- and middle-income countries (LMICs) the challenges are manifold. A large majority of low- and middle-income countries lack technical expertise either to evaluate new medicines or to set efficient medicine prices. The countries also lack comparator reference pricing data to set prices. Also, there are significant out-of-pocket expenditures as people pay for medicines by themselves. An effective medicine pricing policy is vital in the context that it can be used as a tool to improve access and affordability among the masses. This discussion paper presents a conceptual framework to build effective medicine pricing policies for low and middle-income countries (LMICs). The enablers to build effective medicine pricing policies are also discussed. This includes (a) data and statistics on the pharmaceutical situation of the country (b) Having a national medicine policy in the country (c) The availability of the medicine pricing data and (d) Human resources and technical capacity. WHO has recommended several strategies including External Price Referencing (EPR), Internal Reference pricing, Value-based pricing, Cost-plus pricing, and Generic medicine policies to build a pricing policy. However, this information is generic and it's a complex task for countries to tailor to their needs, hence a critical analysis is provided on these policies. The concepts related to fair medicine pricing, providing information to consumers and price transparency are also discussed.

Flourishing and the scope of medicine and public health

A framework is put forward for the proper scope of considerations concerning flourishing within medicine, psychiatry, clinical counselling, public health and public policy. Each of these disciplines and associated institutional...

Analysis of the Application of the "14th Five-Year Plan" for the Development of Traditional Chinese Medicine in Grassroots Hospitals in the Post-Epidemic Era

The application of TCM treatment methods provided important support for the prevention and treatment of COVID-19 and also brought opportunities for the development of TCM. In the post-pandemic era, the good effects of traditional Chinese medicine have enabled its promotion and application in primary healthcare, laying the foundation for the development of traditional Chinese medicine policies. With the promulgation and application of plans such as the "14th Five Year Plan" for the development of traditional Chinese medicine, this article studies the existing problems and provides corresponding suggestions based on the specific content and application overview of the policy. The problem is that there are discrepancies between the formulation of plans and the actual situation in the region and insufficient specific management efforts in the implementation of plans during the policy implementation process. Based on this, this article proposes the following suggestions. Improvements need to be made from three aspects: establishing an effective management system that is lacking, strengthening education and publicity efforts, and coordinating and planning various development matters.

The American Journal of Emergency Medicine's policy on large language model usage in manuscript preparation: Balancing innovation and responsibility

Large Language Models (LLMs) represent a transformative advancement in the preparation of medical scientific manuscripts, offering significant benefits such as reducing drafting time, enhancing linguistic precision, and aiding non-native English speakers. These models, which generate text by learning from extensive datasets, can streamline the publication process and maintain consistency across collaborative projects. However, their limitations, including the risk of generating plausible yet incorrect text and the potential for biases, necessitate careful oversight. Ethical concerns about accuracy, authorship, and transparency need to be carefully considered. The American Journal of Emergency Medicine has adopted a policy permitting LLM use with full disclosure and author responsibility, emphasizing the need for ongoing policy evolution in response to technological advancements.

HPR33 Short- and Long-Term Impacts of the National Essential Medicines Policy on Drug in Rural China

HPR33 Short- and Long-Term Impacts of the National Essential Medicines Policy on Drug in Rural China

Drawing up the public national Rational Pharmacotherapy Action Plan as part of social and health services reform in Finland: a bottom-up approach involving stakeholders

BackgroundEnsuring equal access to medicines and their appropriate and safe use at reasonable costs are core functions of health systems. Despite that, few descriptions of national medicines policies' development processes and implementation strategies have been published. This study aimed to describe the government program-based development of the Rational Pharmacotherapy Action Plan in Finland as a part of the undergoing major health and social service system reform, also covering the implementation of rational pharmacotherapy in the reformed system and processes.MethodsThe data of this qualitative study consisted of public reports and Steering Group meeting memos related to the development of the national Rational Pharmacotherapy Action Plan that the Ministry of Social Affairs and Health coordinated. Qualitative content analysis applying systems theory and the conceptual framework of integrated services as theoretical frameworks was used as an analysis method.ResultsThe national Rational Pharmacotherapy Action Plan covering 2018–2022 was created in a bottom-up development process involving a wide range of stakeholders. Rational pharmacotherapy was redefined by adding equality as the fifth pillar to complement the previously defined pillars of being effective, safe, high-quality, and cost-effective. The Action Plan formed a normative framework for long-term development, with a vision and principles focusing on people-centeredness, better coordination and management of the medication use processes, the continuity of treatment paths and the flow of patient and medicines information through partnerships, and evidence-informed policies and practices.ConclusionThrough intensive stakeholder participation, the bottom-up approach created a national vision and principles of rational pharmacotherapy along with strong commitment to implementing the goals and measures. The concern lies in ensuring the continuity of the Action Plan implementation and achieving a balanced long-term development aligned with the integrated and reformed national social and health services system. The development of the pharmaceutical system has several national and EU-level dependencies requiring political long-term commitment. While the Action Plan differs from the national medicines policy, it forms a good basis for long-term development covering important parts of medicine policy at the micro, meso, and macro levels of the service system.

Bioethicists Today: Results of the Views in Bioethics Survey

Bioethicists influence practices and policies in medicine, science, and public health. However, little is known about bioethicists’ views. We recently surveyed 824 U.S. bioethicists on a wide range of ethical issues, including topics related to abortion, medical aid in dying, and resource allocation, among others. We also asked bioethicists about their demographic, religious, academic, and professional backgrounds. We find that bioethicists’ normative commitments predict their views on bioethical issues. We also find that, in important ways, bioethicists’ views do not align with those of the U.S. public: for instance, bioethicists are more likely than members of the public to think abortion is ethically permissible but are less likely to believe compensating organ donors is. Our demographic results indicate the field of bioethics is far less diverse than the U.S. population—less diverse even than other academic disciplines—suggesting far more work needs to be done to build an inclusive field.

Self-administration of medicines in secondary schools and colleges by students living with medical conditions: content analysis of school medicine policies in England

Abstract Introduction Every school in England is required to have a policy to support students with a medical condition under statutory guidance issued by the Department for Education.[1] The guidance promotes self-administration of medicines where possible, supervised by an adult. Transition from paediatric to adult healthcare during adolescence should be a process of gradually transferring control and responsibility from parents and other responsible adults to the young person taking the medicine. There are several barriers that might prevent autonomy, but effective self-management of long-term conditions at school is essential for wellbeing and learning.[2] Aim To explore secondary school/college medicine policies displayed online for content regarding the self-administration of medicines by students. Methods This was a group project involving six MPharm students. Each student was assigned one or two of the nine regions of England to explore, covering all regions, and they used search engines to find school websites with accessible health/medicine policies. The group employed purposive sampling within their Region to achieve a diverse sample of schools (e.g. nursery age to college; urban and suburban; public and private/fee-paying). An online data collection form was developed by the group to facilitate consistent, directed content analysis of school health/medicine policies (quantitative and qualitative). The topics reflected issues of interest from their literature review e.g. which medicines were mentioned by name in the policy, and arrangements for bringing long-term medicines to school. One topic within the form was to search for content relating to self-administration of medicines. For this abstract, within the wider study, the policies were subjected to directed content analysis to find any statements relating to self-administration. Results The students analysed 50 school policies across England (3 East Midlands; 1 East of England; 8 London; 7 North East; 8 North West; 10 South East; 4 South West; 4 West Midlands; 5 Yorkshire &amp; Humber). Eighteen of the 25 secondary school/college policies included statements about self-administration of medicines. Many (n=13) were comprehensive, stating that young people with medical conditions should assume complete responsibility under parental supervision. Others (n=4) specified partial self-administration for diabetes, asthma or severe allergies. The remaining school, however, specified that their students could not keep or carry any essential medicines, apart from salbutamol inhalers. Conclusion Most schools have adopted a positive approach to self-administration of medicines consistent with the recommendations of statutory guidance. There is, however, some variation in this approach and a minority of schools that do not promote self-medication and thus still prefer to keep medication stored away from the student. This study highlights a context not commonly studied in pharmacy practice, which is a strength, but has a limitation of a small sample that might not reflect the whole situation in England. Another limitation is possible omission of information by the student researchers, where independent validation by another person would be ideal but not practical in the scope of the short-term study. Pharmacists are well-placed to offer support to schools, and to be a resource for teachers, students and families, and this topic merits further exploration.

BIBLIOMETRIC ANALYSIS OF THE GREATEST NUCLEAR DISASTERS: WHAT IS KNOWN SO FAR AND WHAT ARE THE PROSPECTS?

Abstract. The high potential of nuclear power to combat climate change and support sustainable development plays a critical role in achieving the goal of the Paris Agreement. Moreover, with the ever-increasing demand for electricity, it is essential to consider nuclear power as a reliable source of energy. However, it should be noted that although the risk of a radiological accident is small, it always exists, and therefore it is crucial to have a complete understanding of the management of nuclear power. Herein, we present a statistical review of nuclear accident research at Chernobyl and Fukushima Nuclear Power Plants using bibliometric analysis to identify key patterns in scientific results and current issues in accident research. More than 10,000 articles have been collected from the SCOPUS database covering the periods 1986–2022 and 2011–2022 on Chernobyl and Fukushima, respectively. The results were obtained from two perspectives: first, we identified stages through which pre- and post-accident researches have evolved, and then we analysed the spatial correlation between energy-economic performance and scientific literature for the leading productive countries. From the analysis of research trends, it was found that the number of articles increased sharply immediately after the accident and slightly decreased over time. Among the most attractive subject categories in terms of the largest number of publications and received citations were environmental sciences, medicine and energy policy. The productive country ranking was mostly topped by the country in which the accident occurred. Spatial statistical analysis revealed a strong correlation between the scientific productivity and energy-economic performance of the leading countries.

Citizens' views on prices of medicines reimbursed by the National Health Service: Findings from Italian online focus groups.

Access to medicines is one of the biggest challenges to health systems, affecting society and individuals. This study aims to explore citizens' opinions, perceptionsand attitudes on the model of medicines' research and development (R&D) and price setting of medicines reimbursed by the Italian National Health Service. We run four online focus groups, analysed through thematic analysis. people aged 30-70 years, who had completed at least compulsory schooling (8-10 years), with no specialised knowledge about the subject. healthcare workers, pharmaceutical and device industry employees, researchersand medicine policy board members. We aimed to include a purposive sample of 20 participants, variable in terms of age, educational leveland place of residence. Eleven women and six men participated. The mean age was 53 years (range: 28-73). Most (n = 15) had a university degree or attended secondary schools. Eight had a job, five were not employed,and four were retired. In general, participants supported the role of the public health service. Almost all had limited knowledge of medicines' R&D and price setting. Most asked for transparency on medicine prices and negotiation criteria. Participants considered revenues of pharmaceutical companies disproportionateand most called for containment measures of profits. Most were in favour of a stronger public intervention in R&D and prices' negotiations. Few were sceptical of the public sector's ability to play this role. Medicines' prices were discussed as a health matter. Increasing citizens' awareness ofthese topics is needed by providing spaces and conditions to participate in the discussion, including different perspectives and interests. Members ofBEUC-the European consumer organisation-proposed the project. Altroconsumo, an independent consumer organisation and OCU, a Spanish consumer organisation, participated in developing the project and the main topics to discuss. The Mario Negri Institute and Aplica cooperative-the Spanish methodological team-were involved by BEUC and their national organisations to define the methodology, organisational aspectsand contentsand conducted the focus groups.

A Brief Review on Essential Medicine

The World Health Organization (WHO) initially released its list in 1977, marking the beginning of the Essential Medicine Concept, a significant advancement in medical treatment. One of the most cost-effective aspects of modern healthcare is the appropriate use of vital medications. From expert judgement to evidence-based selection, the selection process has developed. In 1996, the first Indian list was published. Particularly in the public sector and in low- and lower middle-income countries, Essential Medicine Policies (EMLs) have had an impact on the provision of medications and led to a higher availability of essential vs non-essential medicines. Even yet, fair access is not guaranteed by the accessibility of necessary medications, particularly in the public sector.

Identifying policy alternatives to enable the virtual establishment of a veterinarian-client-patient relationship.

This research seeks to identify an existing policy stream around the establishment of a veterinarian-client-patient relationship (VCPR) through telemedicine to provide evidence of, and advance policy alternatives for, states and countries looking to allow this practice responsibly. This is seen as an important step for access to veterinary care, particularly for cats. The multiple streams policy framework requires identification of a centering event, problem stream, policy stream and politics stream in order to have the necessary conditions for policy change to occur. This research identifies that policy stream through thematic content analysis. State-level policies from across the entire USA that address the virtual establishment of a physician-patient relationship were analyzed to provide themes that could be applied to similar policies in veterinary medicine. Ten key themes were identified and further organized into four high-order concepts through the thematic content analysis. Detailed accounting of the specific policy alternatives is provided in the supplementary materials. The themes and concepts presented provide evidence of a robust policy stream. This content analysis, and the supporting supplementary details, provide many options to guide states in the development of sound policies for the virtual establishment of a VCPR by drawing from the more matured field of human medicine.

Medicines policy, access and use in Mexico: a systematic literature review 2000-2022.

Research on medicines access and use is heterogeneous and can be challenging for decision-makers to interpret. Pharmaceutical policy is an additional component for study and is the foundation for the promotion of access and use of medicines. This systematic review summarizes findings from the literature on medicines policy, access and use over the past two decades in Mexico and identifies research gaps that should be addressed. A systematic review of the literature published between 2000 and 2022 was conducted to identify publications on medicines policy, access and use in Mexico. The study followed PRISMA Statement guidelines 2020. A narrative review including content analysis was conducted. A total of 5057 articles were reviewed, of which 77 fit the inclusion criteria. Studies described the lack of an explicit national policy, a misalignment between the legal framework and reinforcement incentives, deficient policy documentation at the national level, and the absence of necessary medicines regulation and transparency. In terms of access to medicines, challenges related to supply, selection, acquisition, distribution and expenditure were noted. Regarding medicine use, key study findings included a lack of adherence to standard treatment guidelines, dispensing, lack of reliable information on medicines, lack of treatment adherence and harmful self-medication. The appropriate use of medicines and adequate access to them are priority topics for the formulation of Mexican pharmaceutical policy. It is critical that further research includes longitudinal studies of medicine access and use, and the consideration of studying the private sector as well as new methodological approaches. Many reported challenges related to access to and use of medicines have persisted across decades, suggesting a lack of effective research-to-practice knowledge transfer and policy implementation.This article is part of the Hospital pharmacy, rational use of medicines and patient safety in Latin America Special Issue: https://www.drugsincontext.com/special_issues/hospital-pharmacy-rational-use-of-medicines-and-patient-safety-in-latin-america/.