Medicine Policy Research Articles

Availability of essential medicines, progress and regional distribution in China: a systematic review and meta-analysis.

Essential medicines are the backbone of healthcare and meet the priority healthcare needs of the population. However, approximately one-third of the global population does not have access to essential medicines. Although China formulated essential medicine policies in 2009, the progress of availability of essential medicines and regional variations remains unknown. Therefore, this study was conducted to evaluate the availability of essential medicines, their progress, and regional distribution in China in the last decade. We searched eight databases from their inception to February 2022, relevant websites, and reference lists of included studies. Two reviewers selected studies, extracted data, and evaluated the risk of bias independently. Meta-analyses were performed to quantify the availability of essential medicines, their progress, and regional distribution. Overall 36 cross-sectional studies conducted from 2009 to 2019 were included, with regional data for 14 provinces. The availability of essential medicines in 2015-2019 [28.1%, 95% confidence interval (CI): 26.4-29.9%] was similar to that in 2009-2014 (29.4%, 95% CI: 27.5-31.3%); lower in the Western region (19.8%, 95% CI: 18.1-21.5%) than Eastern (33.8%, 95% CI: 31.6-36.1%) and Central region (34.5%, 95% CI: 30.6-38.5%); very low for 8 Anatomical Therapeutic Chemical (ATC) categories (57.1%), and low for 5 categories (35.7%) among all ATC groups. The availability of essential medicines in China is low compared with the World Health Organization goal, has not changed much in the last decade, is unequal across regions, and lacks data for half of provinces. For policy-making, the monitoring system of the availability of essential medicines is to be strengthened to enable long-term surveillance, especially in provinces where the data has been missing. Meanwhile, Joint efforts from all stakeholders are warranted to improve the availability of essential medicines in China toward the universal health coverage target. https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=315267, identifier: PROSPERO CRD42022315267.

Revitalization of Community Pharmacists: a Review of Regulation and Implementation

Community pharmacists have implemented standard pharmaceutical practices particularly in procurement and clinical pharmacy. The purposes of this review were describing the role of community pharmacists in safety use of medicine and responses to COVID-19 outbreak urgency. Review of published literature. Practice of Community Pharmacist in Indonesia based on Ministry of Health Regulation. In medicine use, Indonesia has National Medicine Policy since 2006. National Medicine policy will ensure the availability, equality and affordability of medicine including the essential. It guarantees that available medicine will meet standard of safety, efficacy and has good quality. Also, goal of this policy is to enhance rational use of medicine and preventing misuse/ abuse. Indicator of good pharmaceutical services is patient received good quality of medicine, proper information, and prevention of adverse drug reactions (ADRs). Hospital and community pharmacists have implemented Standard of Pharmaceutical Services. Documentation of medicine information and counselling has been reported to Ministry of Health regularly. Many programmes, activities have been conducted to ensure quality of care, including prevention of adverse drug reactions.

Effects of cannabis regulation in Switzerland: Study protocol of a randomized controlled trial.

Cannabis is the most widely used illicit substance. Various countries have legalized cannabis for recreational use. Evidence on the health effects of cannabis regulation remains unclear and is mainly based on observational studies. To date, there is no randomized controlled study evaluating the impact of cannabis regulation for recreational use compared to the illicit market on relevant health indicators. The present study ("Weed Care") is the first to evaluate the impact of regulated cannabis access in pharmacies versus a waiting list control group representing the illicit market on problematic cannabis use as well as on mental and physical health. The study is divided into two parts-a randomized controlled study of 6 months followed by an observational study of 2 years. Participants (N = 374) are randomly assigned to either the experimental group with access to legal cannabis in pharmacies or to the waiting list control group representing the current legal framework in Switzerland, namely the illicit market. After 6 months, all participants will have access to legal cannabis for the following 2 years (observational study). The primary outcome is problematic cannabis use as measured with the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Secondary outcomes are cannabis use patterns, mental disorders (e.g., depression, anxiety, and psychosis) and physical health (e.g., respiratory symptoms). Primary and secondary outcomes will be assessed online every 6 months. The study is approved by the responsible ethics committee as well as by the Swiss Federal Office of Public Health. Findings from this study may provide a scientific basis for future discussions about addiction medicine and cannabis policy in Switzerland. ClinicalTrials.gov (NCT05522205). https://clinicaltrials.gov/ct2/show/NCT05522205.

Gender distribution of editorial board members in critical care journals: Assessment of gender parity

PurposeTo reveal factors related to gender parity on editorial boards of critical care journals indexing in SCI-E. MethodsThe genders were defined according to data obtained from journals' websites between 01—30 September 2022. Publisher properties and journal metrics were analyzed by using Chi-square, Fisher exact, Mann–Whitney U tests, and Spearman's correlation coefficient. Logistic regression analysis was used to reveal independent factors. ResultsWomen's representation on editorial boards was 23.6%. The USA (OR, 0.04, 95% CI, 0.01–0.15, p < 0.001) and Netherlands (OR, 0.04, 95% CI, 0.01–0.16, p < 0.001) as publisher's countries, an IF >5 (OR, 0.25, 95% CI, 0.17–0.38, p < 0.001), publication duration <30 years (OR, 0.09, 95% CI, 0.06–0.12, p < 0.001), multidisciplinary perspective of editorial policy (OR, 0.46, 95% CI, 0.32–0.65, p < 0.001), journals categorized also in nursing (OR, 0.38, 95% CI, 0.22–0.66, p < 0.001), and being a section editor (OR, 0.49, 95% CI, 0.32–0.74, p = 0.001) were associated with gender parity. Europe as a journal continent (OR, 36.71, 95% CI, 8.39–160.53, p < 0.001) was related to gender disparity. ConclusionsFurther efforts are needed to expand diversity policies in critical care medicine.

Semen reproductive potential

Reproductive behavior is a complex related to a system of actions and attitudes taken by a man and a woman regarding the process of conception, bearing and giving birth to children, including planning practices, as well as methods of control. Currently, there is a downward trend in the birth rate, with the percentage of infertile couples being increased, despite the development of reproductive medicine and demographic policy. National programs are aimed at increasing the spread of family planning methods and reducing the number of child marriages. In addition to deep behavioral changes predetermined by the historical, social, economic, cultural and moral situation of an individual and society as a whole, the changes in the birth rate are based on adaptive mechanisms during sexual selection. In particular, a substantial research has focused on identifying additional biomarkers of male fertility in seminal plasma. There have been proven to exist differences in their absolute and relative levels between fertile men and men classified as infertile, based on sperm parameters of the World Health Organization. Studies dating back to the 1920s suggested a multifaceted role for seminal fluid in the reproductive process. It has been established that the paternal biological contribution to pregnancy and related ability to influence the reproductive outcome goes beyond simple provision of male gametes at conception. A new paradigm is emerging detailing an importance of communication between father and mother during gestation as it is associated with maternal tolerance to fetal antigens and, ultimately, pregnancy success.

Sickening: who is protecting pharma consumers?

In 2022, John Abramson published Sickening: How Big Pharma Broke American Healthcare and How We Can Repair It. The book illustrates how large pharmaceutical companies have become misinformation machines that have corrupted peer-reviewed journals, systematic review authors, and guideline committees. Industry influence includes selective reporting of clinical trial results and selection of control groups likely to enhance benefits and disguise side effects. Other documented forms of influence include clear conflicts of interest for members of guideline committees and even direct intimidation. The book concludes with a series of implementable reforms, such as ensuring the accuracy and completeness of evidence, developing an independent National Health Board, designing clinical research to optimize health outcomes, requiring the posting of research data so that independent scholars can replicate analyses, and ensuring the accuracy of direct consumer advertising. Abramson's book is a must read for students of medicine, public health, and public policy.

Please wear a mask: a systematic case for mask wearing mandates

This paper combines considerations from ethics, medicine and public health policy to articulate and defend a systematic case for mask wearing mandates (MWM). The paper argues for two main claims...

Nicotine pouches: a summary of regulatory approaches across 67 countries

IntroductionNicotine pouches are small, permeable pouches containing nicotine. The nicotine may either be derived from tobacco plants or synthetically produced. Nicotine pouches are available worldwide, but little is known as...

The research on Fama-French 5-factor model in the medicine industry during COVID-19

During COVID-19, the diease has changed various aspects on the stock market so dramatically that the stock prices in different industry fields. While Fama-French 5-factor model is one of the most effective stock prices assessment models, the worldwide change during these several years could have the unexpected influence on this professional method. In this research, attempting to find the relationship between medicine policy and the stock price, in order to explain the huge change on the economics progress with this model, the linear regression is adopted to cope with this issue. Results indicate that most of the regression coefficients of the explanatory variables under the five factors have the same significance, with only the difference in the size of the coefficient values. Besides, the larger the value of the policy, the higher the risk premiums of pharmaceutical companies will be, additionally, small minus big, high minus low, robust minus weak, and conservative minus aggressive average returns will decrease, and vice versa. In summary, this paper investigates the effectiveness of Fama-French 5-factor model with the new variable, the medicine policy, based on linear regression and other mathematics methods. In the future, it is of great importance to investigate stock prices under such situation and take other factors into seriously account while doing research. Overall, these results shed light on guiding future policy making and different perspective on medicine industry development.

A Strategic Research Framework for Defeating Diabetes in India: A 21st-Century Agenda.

Indian people are at high risk for type 2 diabetes (T2DM) even at younger ages and lower body weights. Already 74 million people in India have the disease, and the proportion of those with T2DM is increasing across all strata of society. Unique aspects, related to lower insulin secretion or function, and higher hepatic fat deposition, accompanied by the rise in overweight (related to lifestyle changes) may all be responsible for this unrelenting epidemic of T2DM. Yet, research to understand the causes, pathophysiology, phenotypes, prevention, treatment, and healthcare delivery of T2DM in India seriously lags behind. There are major opportunities for scientific discovery and technological innovation, which if tapped can generate solutions for T2DM relevant to the country's context and make leading contributions to global science. We analyze the situation of T2DM in India, and present a four-pillar (etiology, precision medicine, implementation research, and health policy) strategic research framework to tackle the challenge. We offer key research questions for each pillar, and identify infrastructure needs. India offers a fertile environment for shifting the paradigm from imprecise late-stage diabetes treatment toward early-stage precision prevention and care. Investing in and leveraging academic and technological infrastructures, across the disciplines of science, engineering, and medicine, can accelerate progress toward a diabetes-free nation.

Transversal Survey of Emergency Medicine Policy and Quality Metrics in Japan's Regional Health Care Plans.

It is essential to establish appropriate medical quality metrics and make improvements to safely and efficiently deliver optimum emergency medical services. The Ministry of Health, Labor and Welfare (MHLW) recommends prefectures to establish numerical quality metrics in their regional healthcare plans (RHCP). The 7th RHCP was issued by the MHLW in 2017 along with a notice of planning in covering the six-year period from 2018 to 2023. In this descriptive study, the emergency medicine policies in the 7th RHCP of each prefecture were analyzed from a quality improvement perspective. The authors examined the chapters on emergency medicine in the RHCPs of 47 prefectural governments for the overall structure, cost-benefits, and connection to community-based integrated care systems. The type and number of clinical measures listed as numerical metrics and their classification methods were emphasized. Regarding the overall plan structure, 40 prefectural governments began their description with an analysis of current surroundings. In total, 24 prefectural governments mentioned community-based integrated care systems but none mentioned cost-benefit analysis. Altogether, only 43 of 47 prefectural governments (91%) indicated numerical metrics. The maximum number of numerical targets for quality measures by prefecture was 19, the minimum was 0, and the median was 4 (IQR: 3-6.5); there were 220 metrics in total, with 82 structural, 96 process, and 42 outcome measures. Additionally, 13 prefectures (28%) classified quality measures according to the MHLW's guidance, 6 (13%) used their own classification manner, while the others did not classify their measures. There were significant differences in emergency medicine policies and quality metrics among the prefectural governments. Further research is needed to develop and establish more comprehensive and appropriate metrics based on a common methodology to improve the quality of emergency medicine.

The National Medicines Policy 2018-22 in Poland. From Creation to Implementation

The National Medicines Policy 2018-22 in Poland. From Creation to Implementation

Abstract IA008: How to move a preventative agent from design into approval

Abstract Cancer prevention is a global public health challenge that requires a multidisciplinary approach including biology, epidemiology, medicine, nutrition, education, clinical trials and public policy. An intent-to-treat analysis of a randomized controlled trial differs from that in the observational setting, therefore, it is important to understand the underlying disease process and aspects of the intervention through research. The genetic heterogeneity of some cancers strongly support an enhanced focus on prevention as a strategy in high-risk individuals. Important factors when developing preventative cancer agents include the time course of the intervention, dose and duration of exposure needed to effect risk reduction, trial endpoints, durability of the impact of intervention, and methodological problems in implementing and interpreting randomized trials to evaluate prevention strategies. The clinical development of cancer prevention therapeutics has many challenges, including the long duration necessary to conduct trials, the lack of adherence to therapy, and unanswered questions on the best endpoint remain. The government, whether it be local, state or national, plays a vital role in regulation and education. The history of chemoprevention regulatory approvals has taught us that these programs are important in the fight against cancer. The Food and Drug Administration has identified barriers to clinical trial participation and challenges in surrogate endpoints, although with a multidisciplinary approach including communication with industry, are extremely positive about the future direction of chemoprevention research. Citation Format: Danielle Krol. How to move a preventative agent from design into approval [abstract]. In: Proceedings of the Second Biennial NCI Meeting: Translational Advances in Cancer Prevention Agent Development (TACPAD); 2022 Sep 7-9. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_2): Abstract nr IA008.

Cancer Prevention in Brazil

This article discusses possible dialogues between medical history and the history of concepts, suggesting that a “socio-conceptual-moral” history of medicine offers insightful elements for the historical analysis of conceptual change. Drawing mainly from Reinhart Koselleck’s Begriffsgeschichte and Ludwik Fleck’s theory of knowledge, I focus on three points of the “socio-conceptual-moral” perspective: the approach to medical statements as part of a semantic field, the interaction between a formulated concept and its practice, and negotiations about the meanings of medical concepts between different social arenas. I take the history of cancer prevention in Brazil as a case study to discuss these three aspects and emphasize the situated character of conceptual change. The article analyzes the period between the 1960s and the 1990s when substantial changes in the conceptual framework of cancer prevention confronted continuities in public health and medicine practices, policies, and institutions.

Implementation of medicines pricing policies in sub-Saharan Africa: systematic review

BackgroundHigh medicine prices contribute to increasing cost of healthcare worldwide. Many patients with limited resources in sub-Saharan Africa (SSA) are confronted with out-of-pocket charges, constraining their access to medicines. Different medicine pricing policies are implemented to improve affordability and availability; however, evidence on the experiences of implementations of these policies in SSA settings appears limited. Therefore, to bridge this knowledge gap, we reviewed published evidence and answered the question: what are the key determinants of implementation of medicines pricing policies in SSA countries?MethodsWe identified policies and examined implementation processes, key actors involved, contextual influences on and impact of these policies. We searched five databases and grey literature; screening was done in two stages following clear inclusion criteria. A structured template guided the data extraction, and data analysis followed thematic narrative synthesis. The review followed best practices and reported using PRISMA guidelines.ResultsOf the 5595 studies identified, 31 met the inclusion criteria. The results showed thirteen pricing policies were implemented across SSA between 2003 and 2020. These were in four domains: targeted public subsides, regulatory frameworks and direct price control, generic medicine policies and purchasing policies. Main actors involved were government, wholesalers, manufacturers, retailers, professional bodies, community members and private and public health facilities. Key contextual barriers to implementation were limited awareness about policies, lack of regulatory capacity and lack of price transparency in external reference pricing process. Key facilitators were favourable policy environment on essential medicines, strong political will and international support. Evidence on effectiveness of these policies on reducing prices of, and improving access to, medicines was mixed. Reductions in prices were reported occasionally, and implementation of medicine pricing policy sometimes led to improved availability and affordability to essential medicines.ConclusionsImplementation of medicine pricing policies in SSA shows some mixed evidence of improved availability and affordability to essential medicines. It is important to understand country-specific experiences, diversity of policy actors and contextual barriers and facilitators to policy implementation. Our study suggests three policy implications, for SSA and potentially other low-resource settings: avoiding a ‘one-size-fits-all’ approach, engaging both private and public sector policy actors in policy implementation and continuously monitoring implementation and effects of policies.Systematic review registrationPROSPERO CRD42020178166

Long-Awaited AAP Hyperbilirubinemia Guidelines Have Arrived.

Long-Awaited AAP Hyperbilirubinemia Guidelines Have Arrived.

An overview of Personalized Medicine landscape and policies in the European Union.

The spread of Personalized Medicine (PM) over the last decade defined a revolution in healthcare systems. PM is among the priorities of the European Commission's research agenda, which funded the IC2PerMed international project aiming to integrate China into the International Consortium of PM (ICPerMed). In the context of this project, we mapped the existing policies related to PM in the European Union (EU) and at the EU Member States (EU-MS) level. PubMed, Google Scholar, Google, Microsoft and national and international institutions' official repositories were searched in order to identify documents on PM-related policies, programmes and action plans at the EU and EU-MS level, published up to December 2020. We identified 28 policies in the EU aimed at improving public health promoting and fostering PM implementation, through some actions including the standardization of good medical practice, use of big data and digital innovation, data sharing and cross-border interoperability, healthcare sustainability, disease prevention and patients'/citizens' engagement. We identified 23 policies at EU-MS level which, notwithstanding national differences, have a common focus, such as patient-tailored treatment and targeted prevention, education of healthcare workers, research and innovation, big data harmonization and healthcare system sustainability. The definition of an integrated regulatory framework is essential to turn PM into an opportunity for citizens and patients with the involvement of all the stakeholders. This work can provide a valuable tool for decision-makers to define common approaches, priorities for research, development and increase international collaboration, which could overcome the fragmented European scenario and align the future direction on PM.

Family Physician Racial Identity: An Analysis of "Other" Race Selection and Implications for Future Data Collection.

Family physicians who report their race as "Other" in a single best option question find the existing categories and forced choice of one category to be problematic. Our analysis of open-text responses in the "Other" race category supports a modification in the way these data are collected to provide more accurate and meaningful ways to understand the workforce and move toward more diverse, equitable, and inclusive policies in family medicine.

An analysis of the essential medicines policy in primary care: Findings from MedMinas project.

Background: Essential Medicines Policy (EMP) has been adopted in Brazil to improve the provision and use of pharmaceuticals. This mixed methods study aims to bring evidence of the EMP implemented in municipalities in the context of primary care in Minas Gerais (20,997,560 inhabitants), Southeast Brazil. Methods: We analysed the core output of the EMP, i.e., the municipal essential medicines lists (MEML) and the effects of the policy on the procurement and availability of medicines. Data sources included a sample of 1,019 individuals (patients, health managers and health professionals), 995 prescriptions, 2,365 dispensed medicines and policy documents from 26 municipalities. Data were collected between April and October 2019. Document analysis and thematic content analysis were performed, and four availability indexes were estimated. Results: The findings suggest an overall lack of standardised and methodologically sound procedures to elaborate the MEML. Funding and public purchasing processes were found to be the major obstacles to medicine procurement. Only 63% of medicines were available at public community pharmacies and just 46.2% of patients had full access to their pharmaceutical treatment. Conclusion: This study reveals weaknesses in the implementation of EMP and a clear disconnection between medicines selection, procurement, and availability, the three core elements of the supply system. These findings contribute to informing future policy improvement actions to strengthen this system. Other countries aiming to advance towards universal health coverage may learn from the challenges that primary care in Brazil still needs to address.

A Survey of Kenya’s Policies, Institutional Arrangements and Legislation on Traditional Medicine

Traditional medicine (also called ethno-medicine) is indigenous medicine based on traditional medicinal knowledge systems and passed down by word of mouth from generation to generation within the particular indigenous community, especially along familial lines as well as through informal apprenticeships; and which is largely undocumented. For a long time Kenya lacked policies, institutional arrangements and legislation on traditional medicine. Years later that scenario has changed, as the country now has an extensive policy framework and institutional arrangements on traditional medicine, comprising an avalanche of policies and institutional arrangements on the subject. It also has an extensive corresponding legislative framework comprising several pieces of legislation that are scattered over several sectors and line ministries and touching on one or other aspect of traditional medicine. New policies have been made, new legislation promulgated, and some of the then existing legislation amended. The earlier situation, and which has as already stated changed, was perhaps attributable to the nascent stage of traditional medicine policy and legislation at the time. With the effluxion of time, there have been marked developments in Kenya’s policies , institutional arrangements, and legislation on the subject. Notably however, although the effective operation of these institutional arrangements together with that of these scattered pieces of legislation can to some extent promote or impact positively on traditional medicine, they are bedeviled by lack of coordination and harmonization. This paper makes recommendations that if implemented can provide the much-needed coordination and harmonization in Kenya’s policies, institutional arrangements and legislation to ensure effective management and development of traditional medicine.