The Future of Occupational and Environmental Medicine.

ABSTRACT: Occupational and environmental medicine (OEM) is an ACGME-accredited preventive medicine specialty focused on work as a social determinant of health and population health. OEM providers recognize and mitigate workplace and environmental hazards, treat resultant injuries and illnesses, and promote the health, wellness and resiliency of workers and communities. Multidisciplinary residency training in clinical medicine, epidemiology, public and population health, toxicology, exposure and risk assessment, and emergency preparedness equips them with the skill set needed for leadership roles in diverse settings. These include clinical practice, academia, corporate settings, and governmental agencies. Despite robust job opportunities, a shortage of formally trained OEM physicians remains and is expected to worsen given a declining number of training programs. We examine root causes of the system-level issues impacting the supply of OEM physicians and potential solutions.

Occupational safety and health in shared workplaces according to workplace inspection reports.

The aim of this study was to create a holistic view of shared workplaces and the ways in which these 'special situations' for organizing work take place in practice. The characteristics of shared workplaces and the associated phenomena and challenges were also points of interest. Occupational safety and health inspection reports (N = 200) from the Regional State Administrative Agency of Finland were analysed to obtain information on the deficiencies observed in shared workplaces. The observations were categorized, and the categories were linked to the elements in the work system model. Thus, observation profiles for shared workplaces in the construction, manufacturing and mining and quarrying industries were created. In the observation profiles, significant differences were identified between two or more industries in terms of deficiencies related to organization, employee, task, tools and technology as well as work environment, i.e., the elements comprising the work system model.

The Current State of Opioid Prescribing and Drug Enforcement Agency (DEA) Action Against Physicians: An Analysis of DEA Database 2004-2017.

BACKGROUND: Prescribing opioids has become a challenge. The US Drug Enforcement Agency (DEA) and Centers for Disease Control and Prevention (CDC) have become more involved, culminating in the March 2016 release of the CDC's "Guidelines for Prescribing Opioids for Chronic Pain." OBJECTIVES: Given the new guidelines, we wanted to see if there have been any changes in the numbers, demographics, physician risk factors, charges, and sanctions involving the DEA against physicians who prescribe opioids, when compared to a previous DEA database review from 1998 to 2006. STUDY DESIGN: This study involved an analysis of the DEA database from 2004 to 2017. SETTING: The review was conducted at the Henry Ford Health System Division of Pain Medicine. METHOD: After institutional review board approval at Henry Ford Health System, an analysis of the DEA database of criminal prosecutions of physician registrants from 2004-2017 was performed. The database was reviewed for demographic information such as age, gender, type of degree (doctor of medicine [MD] or doctor of osteopathic medicine [DO]), years of practice, state, charges, and outcome of prosecution (probation, sentencing, and length of sentencing). An internet-based search was performed on each registrant to obtain demographic data on specialty, years of practice, type of medical school (US vs foreign), board certification, and type of employment (private vs employed). RESULTS: Between 2004 and 2017, Pain Medicine (PM) had the highest percentage of in-specialty action at 0.11% (n = 5). There was an average of 18 prosecutions per year vs 14 in the previous review. Demographic risk factors for prosecution demonstrated the significance of the type of degree (MD vs. DO), gender, type of employment (private vs. employed), and board certification status for rates of prosecution. Having a DO degree and being male were associated with significantly higher risk as well as being in private practice and not having board certification (P < .001). In terms of type of criminal charges as a percent of cases, possession with intent to distribute (n = 90) was most prevalent, representing 52.3% of charges, with new charges being prescribing without medical purpose outside the usual course of practice (n = 71) representing 41.3% of charges. Comparison of US graduates (MD/DO) vs. foreign graduates showed higher rates of DEA action for foreign graduates but this was of borderline significance (P = .072). LIMITATIONS: State-by-state comparisons could not be made. Specialty type was sometimes self-reported, and information on all opioid prosecutions could not be obtained. The previous study by Goldenbaum et al included data beyond DEA prosecution, so direct comparisons may be limited. CONCLUSION: The overall risk of DEA action as a percentage of total physicians is small but not insignificant. The overall rates of DEA prosecution have increased. New risk factors include type of degree (DO vs. MD) and being in private practice with a subtle trend toward foreign graduates at higher risk. With the trend toward less prescribing by previously high-risk specialties such as Family Medicine, there has been an increase in the relative risk of DEA action for specialties treating patients with pain such as PM, Physical Medicine and Rehabilitation, neurology, and neurosurgery bearing the brunt of prosecutions. New, more subtle charges have been added involving interpretation of the medical purpose of opioids and standard of care for their use. KEY WORDS: Certification, CDC, criminal, DEA, opioid, prescribing, prosecution, sanctions.

From guidance to practice: Promoting risk communication and community engagement for prevention and control of coronavirus disease (COVID-19) outbreak in China.

Integrating risk communication and community engagement into the national public health emergency response is crucial. Considering the difficulties and challenges faced by China in the prevention and control of coronavirus disease (COVID-19) and based on interim guidelines from the World Health Organization, this article makes several recommendations addressing the outbreak in China. These include improvements in the internal governmental risk communication systems, enhancing the coordination between internal and partner governmental emergency management, and promoting public communication in response to societal concerns. Regarding these recommendations, we emphasize community engagement in joint prevention and control, confronting uncertainty and countering rumors effectively, and strengthening international cooperation and evidence-based decision making for prevention and control measures.

Integrating Data To Advance Research, Operations, And Client-Centered Services In California.

The value of using administrative records for operational and evaluation purposes has been well established in health and human services. However, these records typically reflect the reach of a single government agency or program and fail to capture the experiences of individuals as they engage with different agencies or programs over time. Thus, the potential for these data to improve everyday operations, coordinate services, develop targeted interventions, and advance the science behind broader social policies has yet to be fully realized. A first step toward realizing that potential is to transition from an agency-centered to a client- or person-centered organization of data. We systematically linked tens of millions of records across California's largest health and human services programs. Our results underscore how the integration of records can help shift discussions from the programs that administer services to the people who are served.

Regulatory perspectives on next-generation sequencing and complementary diagnostics in Japan.

INTRODUCTION: The 'one biomarker/one drug' scenario is unsustainable because cancer is a complex disorder that involves a number of molecular defects. In the past decade, major technological advances have lowered the overall cost and increased the efficiency of next-generation sequencing (NGS). AREAS COVERED: We review recent regulations on NGS and complementary diagnostics in Japan, mainly focusing on high-quality studies that utilized these new diagnostic modalities and were published within the last 5 years. We highlight significant changes in regulation, and explain the direction of efforts to translate the results of NGS and complementary diagnostics into clinical practice. EXPERT OPINION: NGS holds a number of advantages over conventional companion and complementary diagnostics that enable simultaneous analyzes of multiple cancer genes to detect actionable mutations. Parallel technological developments and regulatory changes have led to the rapid adoption of NGS into clinical practice. NGS-based genomic data have been leveraged to better understand the characteristics of a disease that affects its patient's response to a given therapy. As NGS-based tests become more widespread, however, Japanese authorities will face significant challenges particularly with respect to the complexity of genomic data, which will have to be managed if NGS is to benefit patients.

From patent to patient: analysing access to innovative cancer drugs.

Analysis of cancer drugs licensed through the European Medicines Agency (EMA) in 2000-2016 shows that the number of authorisations increased over that timeframe. The median number of licensed drugs each year rose from six for 2000-2008 to 13.5 for 2009-2016. Over 2000-2016, there were 64 drug authorisations for haematological, 15 for breast, and 12 for skin cancer, but none for oesophageal, brain, bladder, or uterine cancer. Only 6% of authorisations included a paediatric indication. The average time for a drug to progress from patent priority date to availability on the National Health Service (NHS) increased from 12.8 years for drugs first licensed in 2000-2008 to 14.0 years for those licensed in 2009-2016. There was evidence that the most innovative drugs were not being prioritised for EMA licensing and NICE approval.

Regulatory Issues of Voluntary Certification of Food Supplements in Russia.

When registering food supplements in Russia, restrictions on the labeling and consumer leaflet contents are tightly controlled by the regulatory agencies. Thus, misleading advertising is the most difficult problem with the turnover of these products if information in the commercials does not correspond to the information on indications for use that were agreed upon during state registration (or sanitary and epidemiologic control). An established procedure of voluntary certification enables additional health claims, thus expanding the information in the label and user leaflet. Voluntary certification is the evidence base for the specific characteristics of the products with regard to their efficacy represented by an independent party. This process allows the manufacturer to inform the consumer about the beneficial properties and efficacy of food supplements and enables the buyer to make an informed choice and to avoid buying counterfeit products by purchasing high-quality safe products with proven efficacy; therefore, the buyer can receive a product that is the best match for his needs and expectations. However, since the mid-2000s, several voluntary certification systems have been developed, approved, and included in the Unified Register of Voluntary Certification Systems maintained by the Federal Agency for Technical Regulation and Metrology, Rosstandart. Thus, manufacturers can choose an authority. In addition to the conventional approach to certification requirements and schemes, various outcomes of approved claims and subsequent certification maintenance are possible. The present article analyzes universal principles of voluntary certification, its legal basis, and authority-specific outcomes of the process.

A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways.

BACKGROUND: As regulatory agencies come under increased pressure to review medicines of critical importance through efficient regulatory systems to provide equitable access, the benefits of using expedited review pathways are being explored. These facilitated regulatory pathways (FRPs) provide a variety of review strategies that can also expedite assessments. Stringent regulatory authorities (SRAs) use primary FRPs to accelerate development or to shorten review time. Some emerging national regulatory authorities can implement primary FRPs but are more likely to use secondary FRPs that rely on or recognize an SRA or reference agency decision, the World Health Organization Collaborative Prequalification of Medicines Programme, "altruistic" reviews, or collaborative work sharing. Despite their availability, there are no formal guidelines or consensus for the definition, basic elements, or best practices for FRPs. METHODS: Herein, we present a 4-step pragmatic approach to a framework designed to help agencies determine how best to use FRPs. Each step is based on characteristics identified through research, surveys, literature assessments, regulatory capacity categorization analyses, and practical experience. RESULTS: Step 1 assesses 4 domains of the environment preparedness, step 2 offers process criteria that should be in place to effectively use an FRP, step 3 tiers agencies through a self-assessment of readiness and capacity, and step 4 provides a pathway for agencies to determine the most relevant FRP for their use. Target timelines are proposed for FRPs. CONCLUSIONS: This framework represents the first endeavor to holistically address the multifaceted aspects that should be considered for the effective use of an FRP.

[Conducting Assured Nonclinical Studies in the Pharmaceutical Industry: Good Laboratory Practice (GLP) Study, GLP Inspection, and Standards for Assurance].

Many nonclinical and clinical studies are conducted to submit new drug applications for chemical entities. Nonclinical studies cover pharmacology, pharmacokinetic, and toxicology aspects and provide pharmacologic evidence as well as kinetic and toxicologic profiles of the compounds. The risks and benefits of compounds are evaluated based on these nonclinical studies, especially before initiation of the first human trials. Therefore, using adequate procedures, highly controlled, quality nonclinical data should be obtained. This section shares and discusses items required of good laboratory practice (GLP)-compliant organizations and management systems in GLP facilities in the pharmaceutical industry as well as those required for GLP inspections by the Japanese Pharmaceuticals and Medical Devices Agency. In addition, it explains standard operating procedures for conducting quality, non-GLP, pharmacology, and pharmacokinetic studies.

Scaling Up Misoprostol to Prevent Postpartum Hemorrhage at Home Births in Mozambique: A Case Study Applying the ExpandNet/WHO Framework.

BACKGROUND: Mozambique has a high maternal mortality ratio, and postpartum hemorrhage (PPH) is a leading cause of maternal deaths. In 2015, the Mozambican Ministry of Health (MOH) commenced a program to distribute misoprostol at the community level in selected districts as a strategy to reduce PPH. This case study uses the ExpandNet/World Health Organization (WHO) scale-up framework to examine the planning, management, and outcomes of the early expansion phase of the scale-up of misoprostol for the prevention of PPH in 2 provinces in Mozambique. METHODS: Qualitative semistructured interviews were conducted between February and October 2017 in 5 participating districts in 2 provinces. Participants included program stakeholders, health staff, community health workers (CHWs), and traditional birth attendants (TBAs). Interviews were analyzed using the ExpandNet/WHO framework alongside national policy and planning documents and notes from a 2017 national Ministry of Health maternal, newborn, and child health workshop. Outcomes were estimated using misoprostol coverage and access in 2017 for both provinces. RESULTS: The study revealed a number of barriers and facilitators to scale-up. Facilitators included a supportive political and legal environment; a clear, credible, and relevant innovation; early expansion into some Ministry of Health systems and a strong network of CHWs and TBAs. Barriers included a reduction in reach due to a shift from universal distribution to application of eligibility criteria; fear of misdirecting misoprostol for abortion or labor induction; limited communication and understanding of the national PPH prevention strategy; inadequate monitoring and evaluation; challenges with logistics systems; and the inability to engage remote TBAs. Lower coverage was found in Inhambane province than Nampula province, possibly due to NGO support and political champions. CONCLUSION: This study identified the need for a formal review of the misoprostol program to identify adaptations and to develop a systematic scale-up strategy to guide national scale-up.

How effective is food industry self-substantiation of food-health relationships underpinning health claims on food labels in Australia?

OBJECTIVE: The Food Standards Code regulates health claims on Australian food labels. General-level health claims highlight food-health relationships, e.g. 'contains calcium for strong bones'. Food companies making claims must notify Food Standards Australia New Zealand (FSANZ) and certify that a systematic literature review (SLR) substantiating the food-health relationship has been conducted. There is no pre- or post-notification assessment of the SLR, potentially enabling the food industry to make claims based on poor-quality research. The present study assessed the rigour of self-substantiation. DESIGN: Food-health relationships notified to FSANZ were monitored monthly between 2013 and 2017. These relationships were assessed by scoping published literature. Where evidence was equivocal/insufficient, the relevant government food regulatory agency was asked to investigate. If not investigated, or the response was unsatisfactory, the project team conducted an independent SLR which was provided to the government agency. SETTING: Australia.ParticipantsSelf-substantiated food-health relationships. RESULTS: There were sixty-seven relationships notified by thirty-eight food companies. Of these, thirty-three relationships (52 %) from twenty companies were deemed to have sufficient published evidence. Four were excluded as they originated in New Zealand. Three relationships were removed before investigations were initiated. The project initiated twenty-seven food-health relationship investigations. Another six relationships were withdrawn, and three relationships were awaiting government assessment. CONCLUSIONS: To ensure that SLR underpinning food-health relationships are rigorous and reduce regulatory enforcement burden, pre-market approval of food-health relationships should be introduced. This will increase consumer and public health confidence in the regulatory process and prevent potentially misleading general-level health claims on food labels.

"History, Tradition, and Progress": The ceremony of 150th Anniversary of the National Center for Global Health and Medicine held in Tokyo, Japan.

"History, Tradition, and Progress", a grand ceremony in celebration of the 150th Anniversary of the National Center for Global Health and Medicine (NCGM) was held in Tokyo, Japan on December 3, 2018. Hundreds of distinguished guests from home and abroad attended the grand ceremony. The NCGM is a national research and development agency, which is a type of independent administrative entity. The NCGM originated from a temporary army hospital that was established in Tokyo in October 1868. After several rounds of restructuring and reorganization, the facility became the NCGM in April 2015. The NCGM has various departments, including the Center Hospital, Kohnodai Hospital, the Research Institute, the Center for Clinical Sciences, the Bureau of International Health Cooperation, and the National College of Nursing. The NCGM conducts research in various fields such as infectious diseases, immune disorders, diabetes, and metabolic disorders and it provides advanced and comprehensive medical care. The NCGM also comprehensively provides training for personnel in international cooperation and medicine. "As a research and development entity, the NCGM will continue to fulfil those tasks in accordance with Japan's national policies", Dr. Norihiro Kokudo, the president of NCGM, said in his speech of anniversary opening greeting.

The Opioid Epidemic: Moving Toward an Integrated, Holistic Analytical Response.

In many jurisdictions, public safety and public health entities are working together to enhance the timeliness and accuracy of the analytical characterization and toxicology testing of novel synthetic opioids. The improved sharing and early detection of these analytical data are intended to inform surveillance, interdiction efforts, patient intervention and treatment, all of which are critical to curbing the opioid epidemic. Forensic practitioners working to identify novel synthetic opioids struggle to provide timely results when encountering new or unknown substances, such as the fentanyl analogs. These compounds, which mimic heroin in pharmacologic effect but can be far more potent, are inconsistently present in chemical identification libraries, and are currently largely unavailable as reference materials for analytical comparison. Additionally, federal, state and local governments as well as nongovernmental organizations require potency, toxicity and potential-for-abuse data to evaluate the potential health risks of emerging drug threats. Subsequent scheduling efforts and criminal prosecutions also require these thorough drug characterization studies. Pilot programs have demonstrated that early communication of real-time drug toxicity and analytical data significantly impacts the successful response to emerging opioids. High-quality, real-time, national-level data on chemical composition, toxicological test data, drug toxicity and overdoses, and analysis of seized materials by law enforcement are needed to track drug trends. However, the USA still lacks a national system to coordinate and communicate toxicology, medical and medical examiner and coroner data with the broader medical and law enforcement communities. Opportunities to address these gaps as well as recent advancements collected through interagency efforts and technical workshops in the toxicology and analytical chemistry communities are presented here. Opportunities for partnership, increased communication and expanding best practices to move toward an integrated, holistic analytical response are also explored.

State Hygiene School as a Department of Education in the National Institute of Hygiene in Warsaw

The article presents the history of the establishment of the State School of Hygiene (PSH) in Poland after the First World War. The difficulties faced by the public health service in a country destroyed by war and created after the reunification of the lands, which for over 150 years remained under the control of three powers, were pointed out. It discusses how the foundations of modern teaching in the field of public health were created in the National Institute of Hygiene (PZH) in Warsaw, an institution to which the Ministry of Public Health entrusted tasks related to health education in the country. The State School of Hygiene was built by the Polish Government with a significant financial contribution from the John Davison Rockefeller Foundation. The official opening ceremony took place on 20 April 1926. The State School of Hygiene in Warsaw was the first such school in Europe. It educated professional staff for the health service in Poland, especially sanitary physicians, sanitary inspectors, nurses and staff to work in health offices. The importance and scope of influence of the State School of Hygiene as the Department of Education in the National Institute of Hygiene was constantly increasing, as evidenced by the number of students (about 800 per year) participating in courses, especially in the first years after its establishment. By the end of 1935, 6,389 students had completed the courses, including 1,900 physicians. Apart from the teaching activities, the State School of Hygiene also carried out research work. The State School of Hygiene was supported by the Rockefeller Foundation, which funded scholarships for the employees of the National Institute of Hygiene at university centers in the USA

Clinical Research from a Health Insurance Database: Practice and Perspective / 대한내과학회지

Health insurance big data not only provide real-world evidence of unmet needs in actual clinical practice but also of breakthroughs in the medical industry which will shape the future of health care. Big data are also expected to transform the existing medical paradigm and provide a truly personalized medical age. However, questions about research through the collection and utilization of various big data in various fields have also been raised because quality limitations cannot be overlooked. Therefore, many challenges remain to be overcome in the use of big data research as a basis for changing medical practice. Intervention and interpretation by clinical medical experts are required in judging the scientific trustworthiness of the big data analysis process and the validity of the results. Therefore, healthcare big data research cannot achieve its goal by the efforts of researchers alone. Teams of data analysis scientists, epidemiologists, statistics experts, and clinical researchers are required to collaborate closely with team members, from the design phase to expert consultation, through regular meetings. In addition, it is necessary, in the creation of a healthier community, to cooperate with government agencies that provide data based on the whole nation or the world's population, as well as interest groups representing the people, and policy-making organizations. In this paper, we describe the knowledge, practical clinical applications, and future research directions and prospects for the next phase of health care, from the design of clinical research using health insurance big data to report writing.

[Problems with Advertisements for Health Foods].

We have been studying the way advertisements for medicines have been monitored by the Health, Labour and Welfare Sciences Research Grants. In the last fiscal year, we identified products that were being advertised to general consumers, such as OTC drugs and designated quasi-drugs, and made recommendations to the Ministry of Health, Labour and Welfare on the methods of advertisement. Members of our research group, including physicians, pharmacists, and consumers, pointed out that advertisements for so-called health foods and foods with functional claims were much more unregulated than those for drugs, including OTC drugs. Thus, this fiscal year, we decided to focus on health foods. Advertisements for health foods are regulated by the Health Promotion Act and the Act against Unjustifiable Premiums and Misleading Representations; moreover, in many cases, cautions are issued by the Consumer Affairs Agency or prefectures. Several studies also reported health damage in patients who, because of their belief in advertisements, intentionally discontinued treatment or missed the opportunity to receive appropriate medical treatment. Here, we report inappropriate advertisements for health foods that may cause health hazards.

A neo-institutional analysis of the hidden interaction between the Israeli Supreme Court and the Ministry of Finance: the right to healthcare services.

BACKGROUND: Under structural conditions of non-governability, most players in the policy arena in Israel turn to two main channels that have proven effective in promoting the policies they seek: the submission of petitions to the High Court of Justice and making legislative amendments through the Economic Arrangements Law initiated by the Ministry of Finance. Nevertheless, an analysis of the principal trends emerging from the High Court of Justice rulings and legislative amendments through the Economic Arrangements Law indicates that these channels are open to influence, primarily by forces that are essentially neo-liberal. Little is known about the effects of these trends on the right to healthcare services, which in Israel has not been legislated as an independent constitutional law in Basic Laws. METHODS: We use four major legal cases decided by the Supreme Court of Israel in the past 10 years where the Court reviewed new legislative initiatives proposed by the Economic Arrangements Law in the area of healthcare. We utilize an institutional approach in our analysis. RESULTS: A neo-institutional analysis of the legal cases demonstrates that petitions against the Economic Arrangements Law in the area of healthcare services have been denied, even though the Court uses strong rhetoric against that law and the government more generally in addressing issues that concern access to healthcare services and reforms in the healthcare system. This move strengthens the trend toward a neo-liberal public policy and significantly weakens the legal protection of the right to healthcare services. CONCLUSION: In deciding petitions against the Economic Arrangements Law in the area of healthcare, the Supreme Court allows the Ministry of Finance to be a dominant player in the formation of public policy. In doing so, it may be promoting a goal of strengthening its position as a political institution that aspires to increase the public's trust in the judiciary and especially in the Supreme Court itself, in addition to exercising judicial restraint and allowing more leeway to the executive and legislative branches more generally.

Development of a techno-humanist model for e-health adoption of innovative technology.

BACKGROUND AND PURPOSE: After investing billions of dollars in an integrated Electronic Medical Records (physicians) and Personal Health Records (patients) system to allow both parties to manage and communicate through e-health innovative technologies, Canada is still making slow adoption progress. In an attempt to bridge the human and technological perspectives by developing and testing a holistic model, this study purports to predict patients' behavioral intentions to use e-health applications. METHODS: An interdisciplinary approach labelled as a techno-humanism model (THM) is testing twelve constructs identified from the technological, sociological, psychological, and organizational research literature and deemed to have a significant effect upon and positive relationship with patients' e-health applications adoption. Subjects were Canadians recruited in a mall-intercept mode from a region representing a demographically diverse population, including rural and urban residents. The SmartPLS measurement tool was used to evaluate the reliability and validity of study constructs. The twelve constructs were separately tested with quantitative data such as factor analysis, single, multiple, and hierarchical multiple regression. RESULTS: The hierarchical multiple regression analysis process led us to formulate four models, each hinged on a combination of interdisciplinary variables. Model 1 consisted of the technological predictors and explained 62.3% (p < .001) of variance in the behavioral intention to use e-health. Model 2 added the sociological predictors to the equation and explained 72.3% (p < .001) of variance. Model 3 added the psychological predictors to Model 2 and explained 72.8% (p < .001). Finally, Model 4 included all twelve predictors and explained 73% (p < .001) of variance in the behavioral intention to use e-health applications. CONCLUSIONS: One of the greatest barriers to applying e-health records in Canada resides in the lack of coordination among stakeholders. The present study implies that healthcare policy makers must consider the twelve variables with their findings and implications as a whole. The techno-humanist model (THM) we are proposing is a more holistic and continuous approach. It pushes back to a breakdown of the various technological, sociological, psychological, and managerial factors and stakeholders that are at the root cause of behavioral intentions to use e-health, as opposed to merely observing behavioral outcomes at the end of the "assembly line". Active participation and coordination of all stakeholders is a key feature.