Overview of Pharmaceutical Strategy for Europe (2020) and enlightenment to China's pharmaceutical field.

Under the background of major innovations and changes in international pharmaceutical technology, the continuous development of informatization and digitalization of drug R & D, technology, and the COVID-19 pandemic, the European Commission (EC) issued the pharmaceutical Strategy for Europe (PSE) at the end of 2020 in order to meet the unfinished clinical needs, stimulate industry innovation, enhance the adaptability of the regulatory system, and consolidate the international status of the EC drug regulatory system. PSE is regarded as the "cornerstone" of European health policy in the next five years, which has important guiding significance for the development and management of European pharmaceutical industry. This paper combs and analyzes the background, development strategic objectives and specific measures of PSE, and puts forward policy suggestions in combination with the actual work of China's epidemic prevention and control and industry development, pharmaceutical scientific supervision and encouraging innovation.Copyright © 2022 by the Author(s).

Current Healthcare Policy and Environmental Status of Digital Health Medical Devices in South Korea

Objectives: COVID 19 and increasing unmet needs of health technology had accelerated an adoption of digital health globally and the major categories are mobile-health, health information technology, telemedicine. Digital health interventions have various benefit on clinical efficacy, quality of care and reducing healthcare costs. The objective of the study is to identify new reimbursement policy trend of digital health medical devices in South Korea. Method(s): Official announcements published in national bodies and supplementary secondary research were used to capture policies, frameworks and currently approved products since 2019. Result(s): With policy development, several digital health devices and AI software have been introduced as non-reimbursement by utilizing new Health Technology Assessment (nHTA) pathway including grace period of nHTA and innovative medical devices integrated assessment pathway. AI based cardiac arrest risk management software (DeepCARS) and electroceutical device for major depressive disorders (MINDD STIM) have been approved as non-reimbursement use for about 3 years. Two digital therapeutics for insomnia and AI software for diagnosis of cerebral infarction were approved as the first innovative medical devices under new integrated assessment system, and they could be treated in the market. In addition, there is remote patient monitoring (RPM) reimbursement service fee. Continuous glucose monitoring devices have been reimbursed for type 1 diabetes patients by the National Health Insurance Service (NHIS) since January 2019. Homecare RPM service for peritoneal dialysis patients with cloud platform (Sharesource) has been reimbursed since December 2019, and long-term continuous ECG monitoring service fee for wearable ECG monitoring devices (ATpatch, MEMO) became reimbursement since January 2022. Conclusion(s): Although Korean government has been developed guidelines for digital health actively, only few products had been reimbursed. To introduce new technologies for improved patient centric treatment, novel value-based assessment and new pricing guideline of digital health medical devices are quite required.Copyright © 2023

Pandemic vulnerability knowledge visualisation for strategic decision-making: A COVID-19 index for government response in Australia

Purpose: First, the key vulnerability factors from the literature are identified. Second, using the vulnerability factors as indicators, a composite index is developed. Last, from the index values, a set of vulnerability knowledge maps, showing the vulnerability hotspots, are prepared. Design/methodology/approach: This study aims to develop a pandemic vulnerability knowledge visualisation index to support the strategic decision-making efforts of authorities. Findings: Ten indicators are identified as vulnerability factors that could significantly impact the virus spread risks. Verifying the identified hotspots against the recorded infected cases and deaths has evidenced the usefulness of the index. Determining and visualising the high-vulnerability locations and communities could help in informed strategic decision-making and responses of the authorities to the pandemic. Originality/value: The study demonstrates that the developed pandemic vulnerability knowledge visualisation index is particularly appropriate in the context of Australia. Nonetheless, by replicating the methodologic steps of the study, customised versions can be developed for other country contexts. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Impact of the COVID-19 Pandemic on Cervical Cancer Screening Rates in Colombia: An Interrupted Time Series Analysis, Stratified By Region

Objectives: The objective of this study is to measure the national impact of COVID-19 on cervical cancer screening rates in Colombia in five of its geographic regions to inform future health policy decision making. Method(s): This study utilized a quasi-experimental interrupted time-series design to examine changes in trends for the number of cervical cancer screenings performed in five geographic regions of Colombia. Result(s): In the rural region of Vichada, we found the lowest incidence of cervical cancer screenings, totaling at 3,771 screenings. In Cundinamarca, the region which hosts the capital city, a total of 1,213,048 cervical cancer screenings were performed. The researcher measured the impact on cervical cancer screenings in December 2021 against the counterfactual. This impact was ~269 cases that were not performed in December 2021 as a result of the COVID-19 pandemic compared to the counterfactual. In Cundinamarca, unlike other regions, we observed a stagnant pre-pandemic trend, a sharp drop in screenings in March 2020, and an immediate upward trend starting in April 2020. In the month of April 2020, compared to the counterfactual, there were 27,359 screenings missed, and by the month of December 2021, there were only 5,633 cervical cancer screenings missed. Conclusion(s): The region of Cundinamarca's sharp climb back to pre-pandemic screening levels could signal the relatively stronger communication system in the region, and especially in the capital district of Bogota, in re-activating the economy. This can serve as an example of what should be implemented in other regions to improve cervical cancer screening rates. Areas for further research include the examination of social determinants of health, such as the breakdown of the type of insurance screened patients hold (public versus private), zone (urban versus rural), insurance providers of those screened, ethnicities of the patients screened, and percentage of screenings that resulted in early detection of cervical cancer.Copyright © 2023

The Impact of Stay-at-Home Orders on Binge Drinking Patterns in the US

Objectives: This study aims to evaluate the impact of the stay-at-home orders, especially closing and reopening bars and other drinking establishments, on binge drinking patterns in US populations in Metropolitan Statistical Areas (MSAs). Method(s): Data on binge drinking and heavy binge drinking for this study was extracted from the 2018-2021 Behavioral Risk Factor Surveillance System (BRFSS). Data on regulations were collected by National Academy for State Health Policy. We used two staggered differences-in-differences strategies to account for monthly variations in bar regulations. We implemented a strategy that used never treated states as controls via the Stata package CSDID and a strategy that directly imputed counterfactuals for treated states via the Stata package FECT. The outcomes were measured by the number of binge drinkers or heavy binge drinkers per 1000 population. The treatment effect was estimated while controlling for age, income level, race, chronic conditions, gender, MSA fixed effects, and month fixed effects. Stay-at-home orders were coded as 1 in the first full month of implementation and were assumed to impact the entire state equally. Bars were assumed to reopen if the indoor service has been reactivated at any capacity. Result(s): For heavy binge drinking, the average treatment effect on the treated group was 4.86 per 1000 population (p=0.027) using FECT package and 6.74 per 1000 population (p = 0.025) using CSDID package. No significant effect was found for binge drinking. Conclusion(s): We provide suggestive evidence that stay-at-home orders may have increased heavy binge drinking in metropolitan areas. We estimated this led to a 3.38% (FECT) or 4.68% (CSDID) increase in heavy binge drinking during the pandemic. Future work will assess the characteristics of areas that saw the greatest increase in heavy binge drinking, and explore why heavy binge drinkers were more vulnerable than binge drinkers during the Covid.Copyright © 2023

A critique of clinical economy: reassessing value and care during covid-19—an essay by Eric Reinhart and Daniel Brauner

For decades, American medical practice has been organised around billing codes, with severe consequences for patient care and physician morale. The interruption of routine clinic visits owing to covid-19 presents an opportunity to reconsider the guiding principles of clinical care, write Eric Reinhart and Daniel Brauner

How to read a paper about inequality in respiratory disease: Basic epidemiological principles and how inequalities are measured

Health inequalities in respiratory disease are widespread, and monitoring them is important for advocacy, the design and delivery of health services, and informing wider health policy. In this chapter, we introduce the different ways in which health inequalities can be quantified, including measures that quantify absolute and relative inequalities, and those that measure gaps between groups or differences across the entire social gradient. We consider the strengths and limitations of these different approaches and highlight things to look out for when reading a paper on health inequalities in respiratory health. These include how common the outcome is and whether other factors have been adjusted for, as both can have a crucial impact on interpretation and can lead to misleading conclusions.Copyright © ERS 2023.

The Evolution of the Normative Regulation in Hospital Safety and Security

The aim of the law is to ensure personal, material and organisational conditions for safe work without endangering human health, to prevent work accidents and occupational diseases by defining the rights and obligations of the state, employers and employees. Since 2003, the concept of occupational safety and health commissioning has been included in the law, which plays a prominent role in the commissioning of dangerous technology or work equipment in health care. [...]of the epidemic, not only the so-called back office area, but also in patient care, the concept of remote work appeared in the field of telemedicine, and some other areas, such as in the case of finding analysis. According to the legislation, the employer must register and Investigate all accidents at work. [...]of this, a wave of insourcing started and in several health institutions they started to employ their own doormen again, wh ich raises further problems.

Building Research Capacity in Primary Care Practices That Serve Predominantly Racial and Ethnic Minority Populations

In this commentary, we report on lessons learned over 2 years (2020-2022) from conducting primary care research through a novel alliance of an ACO consisting of independent practices, a health plan, and several academic researchers, with the support of a private foundation. Am J Manag Care. 2023;29(6):In Press _____ Takeaway Points The process of collaborating on research was mutually beneficial for a network of independent practices and a group of academic researchers. * The process benefited the practices by facilitating more precise thinking about quality improvement, motivating the staff, and enabling readiness for health system change. * The process benefited the researchers by illuminating nuances of clinical and organizational workflow and revealing the practices' in-depth understanding of the communities they serve. * If practices have more federally funded opportunities to consistently participate in research, it could help speed greater adoption of payment reform models to promote health equity at the state and national levels. _____ A 2021 National Academies of Sciences, Engineering, and Medicine report, Implementing High-Quality Primary Care, has called out the persistent "neglect of basic primary care research" in the United States.1 A 2020 study by the RAND Corporation found that primary care research represents only 1% of all federally funded projects (including projects funded by the National Institutes of Health, the Agency for Healthcare Research and Quality [AHRQ], and the Veterans Health Administration).2 However, innovation in primary care is central to advancing health care delivery. Leaders in health care innovation recently called for CMS to test a proposal for primary care payment reform in accountable care organizations (ACOs) composed of independent practices (ie, practices not owned by hospitals).3 By innovating in independent practices, these leaders argued that CMS would provide incentives for those practices to stay independent, thereby potentially decreasing the vertical market consolidation that contributes to rising health care costs.3 Yet these same practices may have less experience with the kind of systematic innovation that leads to generalizable insights, because what little funding is available for primary care research is mostly awarded to large academic medical centers.1 AHRQ's practice-based research networks have not fully addressed this gap, as they have struggled to find infrastructure and maintain funding.1 In this commentary, we report on the lessons we learned over 2 years (2020-2022) from conducting primary care research through a novel alliance of an ACO consisting of independent practices, a health plan, and several academic researchers, with the support of a private foundation. [...]ACPNY found that experience with research facilitates innovation and readiness for health system change (lesson 1C).

Current status of telemedicine in Japan: implications for Korea. TT -:.

Background: Since the coronavirus disease 2019 outbreak, telemedicine has become an important means of providing medical care worldwide. This study aims to highlight the implications of establishing telemedicine policies in Korea. Japan's telemedicine policies were reviewed from the time of the first trial to the present official allowance. Current Concepts: Since telemedicine demonstration work began in 1971, telemedicine in Japan has advanced in four stages. The first stage was the operation of a remote regional comprehensive medical information system from 1971 to 1997. The second stage was when telemedicine was officially institutionalized from 1997 to 2018. The third stage was the time of expansion of telemedicine, from the announcement of the "Guidelines for the Implementation of Proper Online Care" in 2018 to when online first-time examinations were temporarily allowed in 2020. The fourth stage began in 2021 when the "Permanent Establishment of Special Cases for Online Care" was announced, and telemedicine has been officially allowed to supplement face-to-face care. Telemedicine usage was estimated to be about 53.65 million in 2021, and the total number of treatments in Japan in 2021 was estimated to be about 1.32 billion, accounting for about 4.1% of medical care. Discussion and Conclusion(s): For the Korean government to establish telemedicine, it needs to be promoted step by step through discussions with the medical community. Also, an appropriate medical remuneration system needs to be prepared along with guidelines reflecting the opinions of the medical community to secure the safety of telemedicine.Copyright © Korean Medical Association.

Identifying institutional barriers when implementing new technologies in the healthcare industry

PurposeVirtual and augmented reality solutions in medicine are generally applied in communication, training, simulation and therapy. However, like most new digital developments, these technologies face a large number of institutional barriers that are inherent to the medical sector.Design/methodology/approachFollowing Richard Scott's view on institutions and organizations, a multiple case study is used to analyze regulatory, normative and cultural-cognitive institutional pillars in the medical industry.FindingsThe results of the study demonstrate that (1) the regulatory pillar inhibits the advancement of new technologies in the approach to treatment, regulation of patient data, educational processes for medical staff, and information and financial flows;(2) the number of barriers increases based on the solution's level of disruption and the number of variable conventional procedures;(3) trust between participants in the medical industry plays an important role in introducing new technologies;(4) new participants need to address certain pillars depending on the area of application.Originality/valueThe authors discuss top-down and bottom-up approaches for overcoming institutional barriers when implementing augmented and virtual reality solutions for companies focusing on the medical market.

Societal drivers of antimicrobial resistance

Antimicrobial resistance is caused by and exacerbates social and health inequalities. Human and animal antimicrobial use is contributing as much as societal failures to dispose of and manage our waste and respect our environment. A multisector, multidisciplinary approach is required to resolve these issues.Copyright © ERS 2023.

Public health decisions in the COVID-19 pandemic require more than 'follow the science'

Although empirical evidence may provide a much desired sense of certainty amidst a pandemic characterised by uncertainty, the vast gamut of available COVID-19 data, including misinformation, has instead increased confusion and distrust in authorities' decisions. One key lesson we have been gradually learning from the COVID-19 pandemic is that the availability of empirical data and scientific evidence alone do not automatically lead to good decisions. Good decision-making in public health policy, this paper argues, does depend on the availability of reliable data and rigorous analyses, but depends above all on sound ethical reasoning that ascribes value and normative judgement to empirical facts. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Ethical considerations for protecting the options of subjects in primary epidemic vaccine trials

Comments on an article by J. T. Monrad (see record 2020-61038-012). Monrad presented several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I-III and is being deployed. Subsequently, consideration is being given to conducting 'trials for another vaccine for the pathogen'. Monrad stated: 'In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.' Monrad discusses several factors meriting careful consideration about the need for developing and testing more than one vaccine: relative efficacy, length of immunity, adverse reactions (reactogenicity), ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID- 19. Ethically, a subject is allowed to quit a trial at any time. But how might this work in a vaccine trial with multiple candidates? If someone has received an experimental vaccine, they need to be informed of what to do should they wish to subsequently try an approved vaccine. But will companies and researchers with financial stakes in one vaccine readily disclose other options either initially or mid-trial? If a subject got experimental vaccine, there may be more of a chance of having an adverse immune reaction to an additional vaccine that is approved. So they may not wish to do anything. Thus, as part of all informed consents for phase three trials, participants need to be told that at the time some vaccine is approved, they will be told whether or not they received the test vaccine or the placebo so as to help participants make their decision as to whether to get another approved vaccine or not. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Vulnerability and antimicrobial resistance

It is now well-recognised that antimicrobial resistance (AMR), or the ability of organisms to resist currently available antibiotics and other antimicrobial drugs, represents one of the greatest dangers to human health in the 21st Century. As of 2022, AMR is a top-10 global public health threat. Various national and transnational initiatives have been implemented to address accelerating AMR, and the pressure to find local and global solutions is increasing. Despite this urgency, surprisingly limited progress is being made in rolling back or even slowing resistance. A multitude of perspectives exist regarding why this is the case. Key concerns include an enduring dependency on market-driven drug development, the lacklustre governance and habitual over-prescribing of remaining antimicrobial resources, and rampant short-termism across societies. While rarely presented in such terms, these disparate issues all speak to the social production of vulnerability. Yet vulnerability is rarely discussed in the AMR literature, except in terms of 'disproportionate effects' of AMR. In this paper, we offer a reconceptualisation of vulnerability as manifest in the AMR scene, showing that vulnerability is both a predictable consequence of AMR and, critically, productive of AMR to begin with. We underline why comprehending vulnerability as embodied, assembled, multivalent and reproduced through surveillance matters for international efforts to combat resistance.Copyright © 2022 Informa UK Limited, trading as Taylor & Francis Group.

A Multicenter Microcosting Study for COVID-19 in Brazil

Objectives: This study aims to evaluate COVID-19 in-hospital costs and identify predictors at a patient-level in Brazil. Method(s): This is multicenter, prospective cohort study that applied time-driven activity-based costing (TDABC) method in five Brazilian reference centers for COVID-19 treatment. Patients hospitalized between March and August 2020 (first wave of the disease) and had their COVID-19 status confirmed by reverse transcription-polymerase chain reaction (RT-PCR) at arrival were included in our sample. The cost information was calculated at the patient level and multivariable analyses were applied to identify clinical predictors of cost variability, considering ICU admissions and patient's comorbidities. Result(s): 830 patients were included into the analysis. The median cost per patient was I$4,428 (IQR 2,019;11,464), and patients hospitalized in ICU demonstrated significative higher costs (p<0.001). Patients hospitalized in ICU the median was I$11,596 (IQR 6,016;23,374), while for those who were hospitalized in ward was 1,895 (IQR 1,050;3,317). Median cost per day was I$ 455 (IQR 308;711) for the total sample, I$690 (IQR I,528;1,046) for ICU patients and I$350 (IQR 255;449) for non-ICU. Gender (p<0.001), Obesity (p = 0.005) and Chronic pulmonary diseases (p = 0.044) were identified as clinical predictors for hospital costs. Conclusion(s): By developing a multicenter microcosting study for COVID-19 this study allowed to measure the variability in resource consumption per patients' according their clinical characteristics. These findings can sustain the development of financially sustainable health policies in middle-income countries such as Brazil.Copyright © 2023

Crise sanitária e atenção primária: a atuação de assistentes sociais nos territórios

Este artigo focaliza a atuação de assistentes sociais na atenção primária em saúde (APS), na pandemia do Covid-19. Discute a crise sanitária, problematizando a ofensiva ultraneoliberal e suas implicações na atenção primária em saúde cuja potencialidade assistencial foi esvaziada por meio de várias medidas tomadas pelo Governo Federal, como mudanças na Política Nacional de Atenção Básica e o Previne Brasil. Foi realizada pesquisa nos Anais do IX Congresso Nacional de Serviço Social em Saúde, destacando trabalhos sobre APS. Foi desenvolvida análise com base no materialismo-histórico-dialético, considerando a historicidade, mediações e contradições. Foram identificados desafios à atuação profissional, como o uso de Tecnologias de Informação e Comunicação (TIC), o teletrabalho, a precarização da política de saúde. Entre as estratégias de ação utilizadas destacam-se: ações educativas, articulação com a rede socioassistencial, entre outras. Considera-se que a negação de direitos como método governamental distancia o horizonte emancipatório do projeto ético-político da profissão.Alternate :The article focuses on the role of social workers in primary health care (PHC) during the covid-19 pandemic. It discusses the health crisis, questioning the ultra-neoliberal offensive and its implications for primary health care, which its care potential has been emptied, through various measures taken by the Federal Government, such as changes in the National Primary Care Policy and Previne Brasil. Research was carried out in the Annals of the IX National Congress of Social Service in Health, highlighting works on PHC. An analysis was developed based on dialectical-historical-materialism, considering historicity, mediations and contradictions. Challenges to professional performance were identified, such as the use of Information and Communication Technologies (ICT), teleworking, and the precariousness of health policy. Among the action strategies used, the following stand out: educational actions, articulation with the social assistance network, among others. It is considered that the denial of rights as a governmental method distances the emancipatory horizon from the ethical-political project of the profession.