ACCJ–EBC Health Policy White Paper 2013

The American Chamber of Commerce in Japan

ACCJ–EBC Health Policy White Paper 2013 Lengthening Healthy Lifespans to Boost Economic Growth

May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 1

Welcome Message

The American Chamber of Commerce in Japan (ACCJ) was established in 1948 by representatives of 40 American companies and has grown into one of the most influential business organizations in Japan. Consisting mainly of executives from American companies, currently the ACCJ has 2,700 members representing 1,000 companies with offices in Tokyo, Nagoya, and Osaka.

The European Business Council in Japan (EBC) is the trade policy arm of 17 European National Chamber of Commerce and Business Associations in Japan and has been working to improve the trade and investment environment for European companies in Japan since 1972. The EBC currently works for around 3,000 local European corporate and individual members with some 400 companies participating directly.

Working closely with the government of Japan, business organizations and others, the ACCJ and EBC strive to promote activities that help develop opportunities and commerce while promoting the interests of their companies and members, and improving the international business environment in Japan.

The information and analysis in this white paper were jointly developed based on the work of representatives of a wide variety of ACCJ and EBC corporate members who provided information and analysis, as well as invested substantial amounts of time and other resources. To the extent possible, we sought to include all views, so that the final product would reflect a balanced, consensus-based set of recommendations. The common bond among the members of our respective associations is the desire to improve the quality of healthcare in Japan and the wellbeing of the Japanese people.

Sincerely, Laurence W. Bates, ACCJ President

Duco B. Delgorge, EBC Chairman

Published May 2013 by: The American Chamber of Commerce in Japan Masonic 39 Mori Bldg. 10F 2-4-5 Azabudai Minato-ku, Tokyo 106-0041 Japan Tel: 81 3 3433 5381 Fax: 81 3 3433 8454 info@accj.or.jp www.accj.or.jp

The European Business Council in Japan Sanbancho POULA Bldg. 2F 6-7 Sanbancho Chiyoda-ku, Tokyo 102-0075 Japan Tel: 81 3 3263 6224 Fax: 81 3 3263 6223 ebc@gol.com www.ebc-jp.com

Š 2013 The American Chamber of Commerce in Japan All rights reserved Design: Custom Media KK

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Background: Linking Health to Economic Competitiveness

The high productivity level of the Japanese labor force is a primary source of international competitiveness for the Japanese manufacturing and services sectors, and a key reason that many foreign companies choose to invest in Japan. Faced with an aging population, more and more attention is shifting to the question of how to invest in health in a way that increases labor productivity and economic competitiveness. It is now more important than ever for the government, healthcare practitioners and private corporations in Japan to focus on promoting wellness and the prevention and early detection of chronic and infectious disease.

The policy recommendations outlined in the joint ACCJ–EBC Health Policy White Paper 2013 were compiled and based on the belief that investing in the health of the Japanese people would not only result in a higher quality of life, but could also boost economic competitiveness by reducing worker absenteeism and disability while increasing labor productivity. Further, we believe these policies could boost the efficiency of healthcare spending and prevent excessive increases in healthcare costs. Healthcare is a strategic investment in the single most vital resource of the nation—its people—helping them live longer, healthier, and more productive lives.

Healthcare providers, governments and company executives around the world are increasingly aware of the potential benefits of wellness and prevention for improving patients’ quality of life, for increasing workforce productivity, and for achieving cost efficiency gains. The policy recommendations in the 36 sections of this white paper are not meant to represent a comprehensive overview, but rather meant as examples of the kinds of policies likely to yield significant positive potential impact. We wish to express our deep appreciation to everyone who contributed to the development of this policy white paper.

Sincerely, William Bishop Danny Risberg Chair Chair ACCJ Healthcare Committee EBC Medical Equipment Committee Bruce Ellsworth Board Liaison ACCJ Healthcare Committee

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A Special Thank You to Our Sponsors

No project of this scope could be accomplished without the combined efforts of many dedicated people. More than 200 people, representing several dozen companies, are registered as members of the ACCJ Healthcare and EBC Medical Equipment committees.

We would like to thank everyone who contributed time and expertise to the development of these policy proposals. In particular, we would like to extend a special thank you to our sponsors who provided funding for the translation and printing, and our in-kind sponsors who provided valuable expertise and time to edit, design, and publicize this document.

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IN-KIND SPONSORS IN-KIND SPONSORS through provision of services

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Table of Contents

General Health Themes 1. Addressing the Growing Economic Burden of Disease............................................ 6 2. Easing the Burden of Noncommunicable Disease.................................................. 15 3. Increase Prevention Through a Centralized, Updated Vaccination Policy................... 21 4. Leverage the Full Value of Advanced In Vitro Diagnostic Tests................................ 26 5. Boost Collaboration Through Greater Use of Healthcare IT..................................... 30 6. Improving Home Medical Care for an Aging Society.............................................. 34 7. Promote Health Through Food with Health Benefits............................................... 37 8. Improve the Public Health Response to Influenza Pandemics and Other Biological Disasters........................................................................... 40 Noncommunicable Disease Topics 9. Prevent Chronic Diseases Through Tobacco Control............................................... 44 10. Increase Early Detection Through Comprehensive Eye Exams................................ 49 11. Promote Oral Care to Prevent Periodontal Disease and Dental Caries....................... 53 12. Increase Sleep Apnea Syndrome Screening......................................................... 57 13. Prevention and Management of Risk Factors for Diabetes....................................... 60 14. Prevent Stroke and Provide Coordinated Care...................................................... 65 15. Increase Early Detection of Peripheral Arterial Disease.......................................... 69 16. Early Intervention in Musculo-Skeletal Disorders to Improve Health and Work Output.................................................................... 74 17. Increase Wellness Through Treatment of Chronic Pain........................................... 78 18. Prevention and Early Detection of Mental Illness................................................... 84 19. Promote Treatment of iNPH to Reduce Gait Impairment and Dementia in the Elderly. 90 20. Early Detection of Abdominal Aortic Aneurysm..................................................... 97 21. Reduce the Risk of Cerebral Infarction by Early Detection of Carotid Plaque........... 101 Women’s Health Topics 22. Prevent Fractures Due to Osteoporosis.............................................................. 105 23. Increase Breast Cancer Screening Levels........................................................... 109 24. Increase Cervical Cancer Screening Levels......................................................... 113 Key Infectious Disease Topics 25. Increase Hepatitis B Screening and Vaccinations................................................ 116 26. Increase Hepatitis C Virus Screening and Treatment........................................... 121 27. Reduce the Spread of Tuberculosis................................................................... 127 28. Establish an HIV Examination System in General Medical Institutions.................... 131 29. Reduce the Spread of Sexually Transmitted Infections......................................... 135 Importance of Enhanced Safety & Infection Control Introduction to the Importance of Enhanced Safety & Infection Control....................... 139 30. Enhance Prevention of Healthcare-associated Infections...................................... 144 31. Improve Infection Control: Closed vs. Open Systems.......................................... 149 32. Skin Antisepsis.............................................................................................. 153 33. Prevent Bloodstream Infections by Using Appropriate Devices.............................. 158 34. Avoid Reuse of Single-Use Devices................................................................... 163 Special Focus Needed on Healthcare Worker Safety Introduction to the Need for a Special Focus on Healthcare Worker Safety................... 165 35. Prevent Needle Stick and Sharp Object Injuries.................................................. 168 36. Safe Handling of Hazardous Drugs to Protect Healthcare Workers......................... 173

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1.

Addressing the Growing Economic Burden of Disease

Current Situation Lifestyle choices in Japan and around the world have resulted in an increase of preventable chronic diseases and conditions that is driving a rise in healthcare costs and a reduction in economic output.1, 2, 3 Healthcare system participants, including governments, employers, practitioners, workers, health insurance providers, and patients are seeking new solutions to promote health while more effectively managing the increasing costs of care.

The good news is that health insurance providers, governments and corporate leaders around the world are increasingly aware of the benefits of wellness and prevention for improving quality of life, increasing workforce productivity, and achieving cost efficiency gains in the healthcare system.

One promising approach is to focus a larger portion of healthcare resources on keeping people well and disease-free. The World Health Organization (WHO) estimates that 80 percent of heart disease and strokes, 80 percent of type 2 diabetes, and 40 percent of cancer could be prevented if people would do three things: eat a healthy diet, exercise, and avoid smoking.4 Additional benefits can be generated through the use of vaccines to prevent diseases, and through early intervention to prevent the onset of diseases or ameliorate the effects of diseases. Early intervention requires screening of high-risk populations to improve the chances of early detection.

Advances in technology enable healthcare practitioners to detect problems and commence preventive treatment sooner and, in many cases, before diseases can take their toll. Although excessive screening can increase costs and result in false positive test results, the appropriate screening of high-risk groups can help people lead longer, healthier, and more productive lives. Once a disease has been detected, early intervention can help prevent serious, costly complications, so that the patient’s condition can be treated and improve, or at least not worsen. For example, controlling high blood pressure with a combination of lifestyle changes and medications can reduce hospitalization from stroke and heart attack and lower the overall human and financial burden. As another example, the screening of bone mass density for women aged 65 years and over can help detect osteoporosis early. Bone mass density screening can help patients understand the need for a better diet and more exercise as a way to reduce the risk of related bone fractures, which are not only painful, but can severely limit a person’s mobility and independence.

The Impact of Health on Economic Productivity Improved health could contribute to an increase in economic output and productivity in Japan in many ways. Such an increase would potentially come from decreased worker disability, as fewer workers take extended periods of time off from work and more choose to delay retirement. An increase would also come from workers taking fewer sick days off from work (less absenteeism) and being more able to perform their best while at work (less presenteeism). A further increase could come indirectly by decreasing the burden of care on family members and by avoiding an increase in the burden of healthcare costs.

According to U.S. data from the Institute for Health and Productivity Management (IHPM), the cost of presenteeism, or low productivity on the job because of health problems such as allergies, arthritis, asthma, back and neck pain, depression, diabetes, and migraines 6 | Lengthening Healthy Lifespans to Boost Economic Growth

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is often more than double the cost of worker absenteeism and medical care.5 A variety of research studies based on U.S. corporate employee wellness programs demonstrate that investments in company programs to promote employees’ physical and mental health can result in sustainable productivity gains as well as improved quality of life.6 Most studies suggest that every one dollar spent on wellness and prevention results in a return on investment (ROI) of roughly three dollars in terms of improved health outcomes, higher productivity, and healthcare savings.7, 8, 9 Investments in physical and mental health promotion programs can become a new source of global competitive advantage in today’s knowledge-based economy.

Japan is well known for having one of the lowest infant mortality rates and the longest life expectancy in the world. Although life expectancy in Japan continues to rise, the oftendiminished quality of life during the later years places a burden on patients, families, healthcare practitioners, healthcare systems, society, and the economy. These burdens can be relieved through programs to promote prevention, early detection, and wellness.

However, as in many other developed countries, the healthcare systems and health policies in place in Japan have traditionally focused on the treatment of medical conditions after they occur, rather than on their prevention.

The Economic Burden of Disease in Japan Health problems experienced by the Japanese population are a significant drag on economic competitiveness and growth in Japan’s aging society. A nationwide survey of 5,000 Japanese adults conducted by the ACCJ Healthcare Committee in November 2011 shows that health problems cost the Japanese economy at least ¥3.3 trillion a year by causing greater absenteeism, greater disability, and lower worker productivity.10 Of this, ¥2 trillion is due to health problems that workers experience themselves, and ¥1.3 trillion is due to health problems of workers’ family members.10 The survey also shows that the two leading causes of economic burden in Japan are mental illness and pain, each of which cause greater economic burdens than physical injury, non-infectious chronic disease, and infectious disease.10 Over 15 percent of the respondents to the ACCJ survey said that they work, but that their ability to work during the previous one month had been undermined by health problems they experienced themselves.10 Ten percent said that they work, but their ability to work during the previous one month had been undermined by health problems of family members.10 This suggests that each month an estimated 16 million Japanese workers’ ability to work is undermined by their own health problems and 10 million workers’ ability to work is undermined by health problems of their family members.10 The good news is that increasing investment in prevention and early detection of disease has the potential to increase the productivity and healthy life span of Japanese workers and support the overall growth of the Japanese economy.

The ACCJ survey findings are consistent with other studies of the economic burden of disease. The Milken Institute estimates that the combined treatment costs, lost productivity, and lost workdays due to chronic disease has cost the U.S. economy $1.3 trillion annually, including $1.1 trillion in lost productivity and $277 billion in medical treatment costs.6 Similarly, data from the American Productivity Audit shows that healthrelated lost productive time for personal and family health reasons cost employers $225.8 billion per year ($1,685 per employee per year) in 2002, of which 71 percent May 2013

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was explained by reduced employee performance at work. Both studies show that mental illness and chronic pain are the leading causes of worker disability and decreased worker productivity.11 The core economic analysis of the ACCJ’s Growth Strategy Task Force white paper, released in 2010, highlights the insufficient growth in labor productivity in Japan and its significantly deleterious impact.12 As outlined in that document and the economic analysis on which it was based, raising productivity is the key to maintaining economic growth in Japan because the nation already has ample capital resources, but faces a shrinking population. Hence, the only input factor it has left to utilize is productivity. However, Japan faces several daunting challenges in this regard: (a) labor productivity is still at less than 60 percent of the U.S. level; (b) labor productivity is even lower, and is growing more slowly, in the services sector. However, services now account for 80 percent of Japan’s GDP, a percentage that is still growing. Hence, increasing labor productivity, especially in the services sector, is tremendously important for Japan’s economic vitality. Improving the health of workers and, thus, boosting labor productivity is essential to expanding the Japanese economy and increasing its international competitiveness.

Increased Global Focus on the Economic Burden of Disease Global attention is focusing more than ever before on the rising incidence and economic burden of noncommunicable diseases such as cancer, diabetes, Alzheimer’s, and cardiovascular disease. The Global Status Report on Noncommunicable Diseases 2010 issued by the World Health Organization WHO, estimates that each 10 percent rise in noncommunicable diseases is associated with a 0.5 percent lower rate of annual global economic growth.13 The implications are inescapable: as the global population ages, the risk of noncommunicable diseases skyrockets, and associated costs could be crippling. Due to rising healthcare costs and lower economic output, societies that are both old and unhealthy are at risk of fiscal unsustainability. The good news is that the WHO report also estimated that every one year increase in life expectancy is linked to a 4.3 percent increase in GDP.13 In September 2011, the General Assembly of the United Nations convened a special session devoted to noncommunicable diseases and adopted a resolution on their prevention, early detection and early treatment.14 Economically healthy societies need populations who can remain productive and active well into their senior years, and that requires keeping people healthy as long as possible.

The World Economic Forum (WEF) rates noncommunicable diseases as one of the top three risks to the global economy and forecasts that rising prevalence of noncommunicable diseases will cost the global economy a total of $47 trillion over the next 20 years.15 To reduce this risk, the WEF launched the Workplace Wellness Alliance and in January 2013 published a report, Making the Right Investment: Employee Health and the Power of Metrics, that presents fresh research on workplace wellness program implementation and evaluation, as well as results and lessons learned from data collection from 25 global companies covering almost 2 million employees.16 Although Japan has lower obesity levels and higher life expectancies than many other developed nations, many of the trends are the same. Japanese political leaders should underscore that future economic prosperity will increasingly be tied to the ability to promote healthy aging. To catalyze action, an annual healthy aging scorecard could assess 8 | Lengthening Healthy Lifespans to Boost Economic Growth

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progress in Japan by tracking engagement in the workforce; healthy eating and exercise; the availability and use of preventive care; and progress on obesity, blood sugar, high blood pressure, and cholesterol.

One encouraging development is that health ministers and other senior health officials from the 21 member economies of the Asia-Pacific Economic Cooperation (APEC) forum are now talking about ways to collaborate on reducing the economic burden of disease and changing health into a competitive advantage for economic growth.17 APEC has a strong track record of capacity building for regulators and sharing best practices, which over time results in regulatory and legislative reform in each of its 21 member economies.18 APEC is a perfect forum for building the capacity of public health officials in the region on ways to set public health goals related to patient and healthcare worker safety, infection control, prevention, early detection, and early treatment of disease, to track progress over time by monitoring key health indicators, and to successfully measure the return on investments in public health. Japan has the potential to be a leader in this APEC initiative and to learn many practical lessons from its APEC neighbors.

Current Policy The Japanese government recognizes that preventive care is important to the health and welfare of Japanese citizens. The goals of Healthy Japan 21—a campaign organized by the Ministry of Health, Labour and Welfare (MHLW) for health in the 21st century—focus on the prevention of lifestyle-related diseases. Japan’s annual special health screening (tokutei kenshin) system, in which all people aged 40 and over undergo an annual health checkup and those at risk of metabolic syndrome receive guidance on how to reduce health risks, was introduced in April 2008. It is one of the first such programs implemented on a national basis in the world. Further, the Basic Plan to Promote Cancer Control includes important provisions for the prevention and early detection of cancer.

Finally, in April 2008 all of Japan’s prefectural governments were required to develop and adopt a set of policies on preventive care.

According to the second phase goals of Healthy Japan 21—which was renewed in June 2012—prevention of chronic disease progression such as diabetes has for the first time been added as one of the project objectives. Now starting in April 2013 each prefecture in Japan is planning to implement practical actions to achieve primary, secondary and tertiary prevention to increase the healthy longevity of people.

While Japan’s government has in place a variety of prevention, early detection, and wellness policies, more could be done that would result in significant gains in quality of life, workforce productivity, and cost efficiency. Although Article 1.2 of the Health Promotion Law of Japan clearly states that healthcare must go beyond treatment to include prevention and rehabilitation, this broader concept of prevention has not been fully integrated into Japan’s public health policies. Currently, Japan’s national health insurance system is based on the philosophy of only paying for screening when a patient is sick or exhibits clear symptoms of being sick. Therefore, the screening of healthy people for many diseases and chronic conditions is often not covered by the national health insurance system, even for those in high-risk groups. Some Japanese companies’ health insurance associations pay for screening of a few non-required screening items at annual employee checkups, but these are a small minority.

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It is important to create financial incentives in the health insurance system to motivate more people to undergo health risk assessments, as well as to adopt healthier lifestyles and behaviors long before the onset of illness, and while the risk of disease can be reduced. In parallel, it is important to shift the health insurance reimbursement model to one according to which healthcare practitioners earn more by keeping patients healthy and out of doctors’ offices and hospitals than by treating patients after they develop chronic diseases. One way to accomplish this is to provide general practitioners with higher reimbursements to promote prevention and early detection in their clinics, because this would help keep more patients out of expensive acute-care hospitals.

Through the implementation of a comprehensive set of new national policies and programs focused on prevention, early detection, prevention of disease progression, the government of Japan can facilitate improvements in health outcomes and patients’ quality of life.

This can help optimize long-term healthcare cost efficiency and boost the productivity of the workforce.

Recommendations • Set health policy priorities based more on areas that will lead to an increase in labor productivity (such as reducing absenteeism and disability), not only based on diseases with the highest mortality rates and healthcare costs.

• Make strategic investments in lengthening the healthy lifespan of the people, which is the most important resource that Japan has.

• Create financial incentives in the health insurance system to motivate more people to undergo health risk assessments, as well as to adopt healthier lifestyles and behaviors long before the onset of illness.

• Shift the health insurance reimbursement model to one according to which healthcare practitioners earn more by keeping patients healthy and out of doctors’ offices and hospitals than by treating patients after they develop chronic diseases.

• Promote efforts to reduce the economic burden of disease through international collaboration among government, academia and the private sector based on the 2011 NCD Action Plan and the 2012 HAI Action Plan adopted by the APEC Life Sciences Innovation Forum.

References

1. According to Organization of Economic Cooperation and Development (OECD) Health Data 2012, total health spending as a percentage of GDP increased from 7.8 percent of GDP in 2000 to 9.5 percent of GDP in 2010 among OECD countries. Also, overweight/obesity rates exceeded 20 percent in 12 OECD member countries and smoking rates averaged 21.1 percent as of 2010. http://www.oecd.org/health/health-systems/oecdhealthdata2012-frequentlyrequesteddata.htm.

2. According to a California Health Care Foundation study in 2008, in the United States employerpaid health insurance premiums increased 97 percent from 1996­–2005 while wages and salaries increased only 39 percent. The study also showed that employer-paid health insurance premiums reached nearly $2,000 per employee and equaled 4.5 percent of total compensation for employees, an increase of more than 40 percent over 10 years.

3. Chronic diseases in Japan are responsible for over half of healthcare costs and lifestyle-related chronic diseases are responsible for roughly one third of healthcare costs. Japan Ministry of Health, Labour and Welfare (MHLW) 2010 Social and Medical Study of Health Care Costs Based on Types of Medical Conditions.

4. World Health Organization, “Preventing Chronic Disease: A Vital Investment.” World Health Organization Global Report, Geneva, 2005.

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5. Presentation to the ACCJ by Sean Sullivan, President and CEO, Institute for Health and Productivity Management, November 2009 and based on various articles in the Journal of Health & Productivity. www.ihpm.org/.

6. Milken Institute analysis based on MEPS, NHIS, etc. presented in its October 2007 report “An Unhealthy America: The Economic Burden of Chronic Disease” by Ross DeVol and Armen Dedroussian. www.milikeninstitute.org or www.chronicdiseaseimpact.com.

7. American Institute for Preventive Medicine website section on corporate wellness programs (www. healthylife.com). Documented cases of ROI of as high as 15 times investment have been seen.

8. For example, benchmarking against companies in similar industries shows that Johnson & Johnson’s Health & Wellness program had a projected ROI of $3.71 for every $1.00 spent (Calculated using the Thomson Reuters ROI Modeling Tool). Johnson & Johnson in the United States had an average rate of growth in employee medical and pharmaceutical costs that was 3.7 percent lower than that of similar companies in similar industries. Leonard L. Berry, Ann M. Mirabito, William B. Baun. “The Pillars of an Effective Workplace Wellness Program.” Harvard Business Review. December 1, 2010.

9. “Workplace Wellness Programs Can Generate Savings,” Katherine Baicker, David Cutler, & Zirui Song, Health Affairs, February 2010, volume 29, no. 2, pp 304–311, http://content.healthaffairs.org/content/29/2/304.abstract.

10. “National Survey of the Economic Burden of Disease” based on an internet survey of 5,000 adults.

Conducted in November 2011 by the Healthcare Committee of the American Chamber of Commerce in Japan. www.accj.or.jp.

11. “Lost Productive Work Time Costs From Health Conditions in the United States: Results from the American Productivity Audit,” Walter F. Stewart, PhD, MPH, Judith A. Ricci, ScD, MS, Elsbeth Chee, ScD, David Morganstein, MS, Journal of Occupational and Environmental Medicine, Volume 45, Number 12, December 2003.

12. Growth Strategy Task Force White Paper, by the American Chamber of Commerce in Japan, 2010. www.accj.or.jp.

13. World Health Organization, “Global Status Report on Noncommunicable Disease.” 2010. www.who.int/nmh/publications/ncd_report2010/en/. The WHO report cites “Population Causes and Consequences of Leading Chronic Diseases: A Comparative Analysis of Prevailing Explanations,” by Stuckler D. from Milbank Quarterly, 2008, 86: 273–326.

14. Resolution A/66/L1 titled “Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Noncommunicable Diseases” adopted by the United National General Assembly in New York, September 19–20, 2011. www.un.org/en/ga/ncdmeeting2011/.

15. “The Global Economic Burden of Noncommunicable Diseases,” a report by the World Economic Forum and the Harvard School of Public Health, September 2011. www.weforum.org/docs/WEF_Harvard_ HE_GlobalEconomicBurdenNonCommunicableDiseases_2011.pdf. For supporting background data, also see “Working Towards Wellness: The Business Rationale.” Geneva, World Economic Forum, 2008.

16. “Making the Right Investment: Employee Health and the Power of Metrics,” Workplace Wellness Alliance, World Economic Forum, Davis, January 2013.

17. Statement by the APEC High-Level Meeting on Health & the Economy, St. Petersburg, June 28, 2012. http://aimp.apec.org/Documents/2012/HWG/HWG-LSIF/12_hwg-lsif_019.pdf.

18. APEC Business Advisory Council letter to APEC health ministers, May 12, 2012 included in annex of the ABAC Report to APEC Economic Leaders. www.abaconline.org/v4/download.php?ContentID=2609958.

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1. The Rise in NCDs Is a Leading Threat to Global Economic Growth WHO report: each 10% rise in NCDs is linked to a 0.5% dip in annual economic growth; recent global rise in NCDs is “economically unsustainable.”

The World Economic Forum forecasts that NCDs will cost the global economy $47 trillion over the next 20 years.

Sources: Stuckler D. “Population causes & consequences of leading chronic diseases: a comparative analysis of prevailing explanations.” Milbank Quarterly, 2008, 86:273–326. Reported in Global Status Report on Noncommunicable Diseases 2010, WHO, http://www.who.int/nmh/publications/ncd_report2010/ en/.

• Working Towards Wellness: The Business Rationale. World Economic Forum, Geneva, 2008. Bloom, et al., 2011.

1. Economic Burden of Disease in Japan Is about ¥3.36 Trillion per Year Cost Type

Loss Due to Absenteeism (¥)

Loss Due to Presenteeism (¥)

Loss Due to Partial Disability (¥)

Loss Due to Full Disability (¥)

Total Economic Loss (¥)

Due to own health problem

360,902,760

281,746,880

893,861,040

466,162,160

2,002,672,840

Due to family health problem

154,775,080

190,952,840

396,201,720

618,093,560

1,360,023,200

Health Issues Undermine Work Ability of 16 Million Japanese Every Year Family Member Health Issues Undermine Work of 10 Million Every Year Cost Type

Estimated Absenteeism (People)

Estimated Presenteeism (People)

Estimated Partial Disability (People)

Estimated Full Disability (People)

Total Economic Loss (People)

Due to own health problem

7,970,576

3,880,412

1,887,768

3,670,66

16,192,854

Due to family health problem

3,880,412

3,251,156

943,884

2,936,52

10,445,650

Source: “National Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan,” American Chamber of Commerce in Japan, 2011.

Estimates based on Projected Population from Japan’s Ministry of Internal Affairs and Communications (104,876,000 adults as of November 2011). Some respondents were impacted by both their own health problems and family member health problems.

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1. Own, Family Health Problems Affect Work Q: Do you or a family member have a health issue (physical injury or disability, infectious disease, non-infectious disease, mental illness, or pain) and has it affected your ability to work or be productive in the past one month? (Multiple choice if yes.) (n=185) (n=380) (n=154) (n=18 )

Due to own health issue Due to family member’s health issue

(n=46) (n=91) (n=139) (n=176) (n = 4502) (n = 4228)

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

1. Mental Illness and Pain Have the Greatest Economic Burdens in Japan Absenteeism (¥)

Presenteeism (¥)

Partial Disability (¥)

Full Disability (¥)

Total Economic Loss (¥)

Physical injury, disability

29 billion

32 Billion

66 billion

28 billion

155 billion

Infectious diseases, viral infection

26 billion

29 billion

47 billion

56 billion

159 billion

Pain

88 billion

53 billion

197 billion

35 billion

372 billion

Non-infectious chronic disease

17 billion

67 billion

74 billion

136 billion

294 billion

Mental illnesses

202 billion

101 billion

510 billion

211 billion

1.023 trillion

Total due to own health problem

361 billion

282 billion

894 billion

466 billion

2.003 trillion

Type of Loss

Source: “National Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan,” ACCJ, 2011. Estimates based on projected population from Japan’s Ministry of Internal Affairs and Communications (104,876,000 adults as of November 2011). The chart is based on people whose ability to work was undermined by their health problems. Excludes people whose ability to work was affected by the health problems of family members.

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1. Health Issues Hurt People’s Ability to Work; Pain Affects the Most People Type of Own Health Problems

Estimated Absenteeism (People)

Estimated Presenteeism (People)

Estimated Partial Disability (People)

Physical injury, disability

2,160,026

935,179

830,618

Infectious disease, viral infection

1,171,675

911,897

353,013

458,833

2,789,702

Pain

4,407,729

1,474,557

726,791

895,641

7,131,568

Non-infectious chronic disease

1,219,498

1,078,755

415,309

1,104,869

3,691,635

Mental illness

2,518,702

1,245,612

851,383

1,607,749

5,495,502

Total

7,970,576

3,880,412

1,887,768

3,670,660

16,192,854

Estimated Full Disability (People) 1,082,845

Total (People)

4,866,246

Source: “National Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan,” ACCJ, 2011. Estimates based on projected population from Japan’s Ministry of Internal Affairs and Communications (104,876,000 adults as of November 2011). This chart is based on people whose ability to work was undermined by their health problems. Excludes people whose ability to work was affected by family health issues.

1. Spending to Promote Health Is a Very Good Economic Investment l The World Health Organization says that every 1 year increase in life expectancy is linked to a 4.3% increase in global GDP. l A recent Harvard-led analysis of 36 studies found that medical costs fall about $3.27 and that absenteeism costs fall about $2.73 for every $1 companies spend on employee wellness programs.

Sources: Stuckler D. “Population causes & consequences of leading chronic diseases: a comparative analysis of prevailing explanations.”

Milbank Quarterly, 2008, 86:273–326. Reported in Global Status Report on Noncommunicable Diseases 2010, WHO, http://www.who.int/ nmh/publications/ncd_report2010/en/.

Harvard-led analysis: Katherine Baicker, David Cutler, & Zirui Song, Health Affairs, February 2010, vol. 29 no. 2 304–311, http:// content.healthaffairs.org/content/29/2/304.abstract.

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2.

Easing the Burden of Noncommunicable Disease

Situation According to the World Health Organization (WHO), of 57 million global deaths in 2008, 36 million, or 63 percent, were due to noncommunicable diseases (NCDs).1 Specific NCDs cited by the WHO include diabetes; chronic respiratory disease, such as chronic obstructive lung disease (COLD); stroke; chronic heart disease; and cancer. However, Alzheimer’s disease, glaucoma, osteoporosis, rheumatoid arthritis, Parkinson’s disease, hypertension, and hyperlipidemia are also NCDs. There are a number of reasons that NCDs were slated as a key policy issue by countries worldwide at the United Nations (UN) Health Summit in September 2011. While NCDs are not communicated from person to person, they are generally difficult to treat because their causes are not easily eliminated. Moreover, unless appropriate medical treatments are continued, these diseases may progress to the point of creating a high risk of unexpected life-threatening events while a person is still middle-aged.

NCDs are fundamentally different from infectious diseases and so cannot be controlled through the same traditional public health policies, programs and strategies. Unless there are commitments by the individuals affected, accompanied by active and aggressive treatments, NCDs can be regarded as a disease group in which the increasing severity of conditions cannot be halted.

Current State of NCDs, Future Predictions The prevalence of NCDs is increasing sharply worldwide among middle-aged individuals and senior citizens.1 The WHO forecasts that the number of global deaths due to NCDs each year could reach 55 million by 2030. The NCD with the highest mortality rate is heart disease (48 percent), followed by cancers (21 percent) and chronic respiratory diseases (12 percent). The number of annual deaths worldwide due to heart disease is predicted to increase from 17 million in 2008, to 25 million in 2030. Cancer-related deaths are expected to jump from 7.6 million to 13 million during the same period.

NCDs are an important health policy issue in the United States. They are regarded not only as a public health issue, but also as a disease group that limits the daily lifestyle of 10 million U.S. citizens, and for which the government spends billions of dollars annually.

The diseases are also regarded as a large factor in the increase in U.S. healthcare expenditure and lower productivity. The U.S. Centers for Disease Control and Prevention (CDC) has been at the forefront of implementing NCD countermeasures over the past 20 years, but impact of those measures has been limited.2 According to the 2010 WHO report on NCDs, 87 percent of the deaths in the United States were due to NCDs.2 Current Status, Issues in Japan According to statistics released by the Ministry of Health, Labour and Welfare (MHLW), the number of deaths due to malignant neoplasms, heart disease, stroke, diabetes, and hypertension in FY2009 accounted for 60 percent of all deaths.3 Even in a nation with advanced healthcare such as Japan, the death rate from NCDs does not differ greatly from the global average.

As Japan’s population ages, there is an increasing possibility that the gap between the average life expectancy and the average healthy life expectancy may grow.4 The gap for men is 9.22 years and for women 12.77 years, which indicates that approximately the last May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 15

ten years of life are spent in a condition possible that, due to treatment of NCDs this final stage of life will not be lived in high medical and nursing care costs are

that cannot be considered as healthy. Thus it is that could have been prevented with proper care, a comfortable manner and it will be a time when incurred.

Closing the gap between life expectancy and healthy life expectancy is a policy issue that is not only a question of finances, but also a fundamental question of how people will live out the final years of their lives.

Despite the fact that the importance of dealing with NCDs has been recognized in global medical and health policy debates for some time, awareness of NCDs remains very low in Japan. According to a 2012 NCD survey (1,791 respondents) conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA), the level of awareness of NCDs among the general public is 8.9 percent.5 This reflects a low level of understanding regarding not only which diseases are NCDs, but also the seriousness of their impact on society and our future.

If the essence of the problems associated with NCDs were properly understood, there would be a correspondingly higher appreciation of the importance of active prevention, early disease discovery through early examination, as well as the need for subsequent regular clinic visits and the start of active treatment. If people had an accurate understanding of NCDs, then opinion survey results would show a higher level of understanding about the importance of active prevention, early detection of disease, and active treatment. The survey results also suggest that if people had a more accurate understanding of NCDs, then one could expect to see more positive behavioral changes, including greater likelihood to have regular health checkups and, in case a disease is found, to voluntarily commence and continue treatment.

In many cases, NCDs are progressive, chronic diseases for which there are no cures and which are likely to lead to a lower quality of life (QOL) or even death if proper treatment is not continued. But even after an NCD has been contracted, there are instances when a certain level of QOL can be maintained over the course of a lifetime, through continuous, active disease management. With advances in medicine, it has become possible to effectively manage many NCDs through active and early treatment. Thus, efforts to promote accurate public awareness and understanding are expected to become increasingly important.

Current Policy In September 2011, a UN Summit declared that NCDs are a “key policy issue that must be addressed by nations worldwide.” This declaration reflects the high level of importance attached to addressing NCDs in global and national medical and healthcare policies and indicates that governments worldwide are taking the initiative to promote active policy discussions about how to respond to the challenge of NCDs.6 In 2012 in Japan, a revised set of “Healthy Japan 21” health policy goals were published. In addition to including goals for primary prevention of chronic lifestyle diseases such as metabolism screening rates, it also mirrors measures used globally to address the four major NCD-related risk factors—smoking, overeating, excessive alcohol consumption, and lack of regular exercise. It also lists numerical targets 16 | Lengthening Healthy Lifespans to Boost Economic Growth

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designed to prevent NCDs, particularly diabetes, from becoming more serious and leading to complications.

For this plan to be implemented successfully and for Japan to achieve its health vision, it is essential for the Japanese government to create an effective plan and to provide financial resources. It is also essential that an effective framework is created in cooperation with local governments that will implement this plan at the prefectural, city, and town levels.

Recommendations Education and Spread of NCD-related Countermeasures • If NCDs are to be understood and NCD-related illnesses are to be prevented from progressing, it is vital that members of the public, patients and their family members have accurate knowledge about and take steps to treat NCDs. NCD-related education and the dissemination of information about how to counter NCDs are extremely important. Public awareness and understanding of ways to counter NCDs should improve as the government, members of the public, and the private sector cooperate to address NCDs and involve the members of the general public and the media to communicate the importance of measures to curb NCDs. Ideally, this would trigger behavioral changes among patients and members of the public, including voluntary and active prevention, early detection, and treatment, and in turn lead to lengthened healthy life spans and improved control of healthcare expenditures.

Family Doctors as Primary Care Specialists • There is an urgent need for greater numbers of more qualified family doctors in Japan.

Rooted as they are in local communities, family doctors are the gatekeepers who provide guidance regarding effective treatment of NCDs. Because NCD patients often have multiple diseases, an environment must be created in which there are more general practitioners who treat and provide guidance for a broad range of diseases, rather than only specialists who treat only one narrow disease area. In addition, a plan is needed to create medical reimbursement incentives that strengthen community medical care by elevating the status of family doctors and sparking desire among more physicians to become family doctors.

Multi-faceted Education System • There is an urgent need for new and expanded university-level courses to develop family doctors. Also medical school and continuing education curricula need to stress the importance of NCD prevention and treatment. The actual medical care system needs to rapidly transition to a community- and home-based system focusing on the family. This calls for appropriate medical staff education and training on NCD prevention and treatment, so that even people as young as elementary school students may live a healthier life.

Collaboration, Responsibilities, Duties • The prevention and treatment of NCDs calls for the involvement of various governmental agencies. For example, the Ministry of Education, Culture, Sports, Science and Technology (MEXT) is responsible for updating university medical courses and the health-education curriculum at primary and secondary schools. Further, only the Ministry of Health, Labour and Welfare can modify healthcare reimbursement and incentive schemes. The Ministry of Internal Affairs and Communications and the May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 17

Ministry of Economy, Trade and Industry set up healthcare networks using advanced health information technology. Given the complex requirements of tackling NCDs, cooperation and collaboration among governmental agencies is essential to promote family-based medical treatment, improve community-based healthcare systems, and resolve the regional gaps in healthcare provision frameworks.

•

In addition, industry, government, academia, and members of the public must work together to implement and execute any plans to increase awareness of NCDs at the community level nationwide. This will require that the central government, prefectures and municipalities cooperate to introduce integrated health policy reforms.

Meanwhile, it will be necessary to clarify where the responsibility lies for implementing and evaluating the necessary healthcare plans. In addition to maintaining proper coordination at governmental level and assigning functional responsibility, numerical target indices should be used to evaluate the effectiveness of these activities and their results, while adjusting policies based on a plan–do–check–act (PDCA) cycle.

References 1.

2.

3.

4.

5.

6.

World Health Organization. Global Status Report on Noncommunicable Diseases 2010. www.who.int.

Centers for Disease Control and Prevention. Global health—noncommunicable diseases. www.cdc.gov/globalhealth/ncd/.

Ministry of Health, Labour and Welfare. Public healthcare costs, FY2009.

Ministry of Health, Labour and Welfare. Healthy Japan 21 (stage two).

PhRMA symposium. 2012. Importance of NCD (noncommunicable disease) measures in the aging nation of Japan, November 26.

United Nations. 2011. Political declaration of the high-level meeting of the General Assembly on the prevention and control of noncommunicable diseases, September 19, 2011.

18 | Lengthening Healthy Lifespans to Boost Economic Growth

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2. Global Status of Noncommunicable Disease l The diseases are aggravated if patients are not aware of their condition and do not undergo treatment l In 2008, 57 million deaths occurred worldwide, 36 million (63%) due to NCDs l NCDs are difficult to cure and are likely to cause unexpected, life-threatening events if adequate treatment is not received l Some 44% of all NCD-related deaths occurred before the age of 70

2008 Global NCD-related Deaths of Persons under 70 Digestive diseases

Other NCDs

Cardiovascular diseases 39% Cancers

Cancers 27%

Diabetes Chronic respiratory diseases

Chronic respiratory diseases + digestive diseases + other NCDs = 30%

Cardiovascular diseases

Diabetes 4%

Source: Global status report on noncommunicable diseases 2010, WHO

2. Japan: NCDs Boost Death, Physical Burden, Healthcare Expenditure NCDs: account for about 30% of national healthcare expenditure, about 60% of total deaths

Mortality

Healthcare Expenditure

Cancers 11.1% Hypertension-related diseases 7.1 Others 68.3%

Cerebral vascular diseases 6.3 Diabetes 4.4% Cardiovascular diseases 2.9%

Cancers 29.5%

Others 42.6%

Cardiovascular diseases 15.8%

Hypertension-related diseases 0.6 Diabetes 1.2%

Cerebral vascular diseases 10.3%

Source: Healthy Japan 21 (stage two)_

May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 19

2. Importance of Healthier Life Expectancy = l Gaps between average life expectancy and healthy life expectancy represent an unhealthy period with daily life constraints l There may be medical and nursing expenses during this period Year 1960 Male

Female

1965

1970

1975

1980

1985

1990

79.64 70.42

9.22 years 86.39

73.62

12.77 years

] Average life expectancy__]Healthy life expectancy_(No daily life constraints) Gap between average and healthy life expectancy Source: Healthy Japan 21 (stage two)_

2. NCD-related Health Policy Recommendations Importance of NCD measures

l Enhance people’s awareness to produce behavioral changes l Government should take initiative; public, private sectors should cooperate l Extend healthy life span through preventive care, early detection, rapid cure

Make family doctor the primary care specialist

l =Set up education system for family doctors to boost numbers, quality

l Promote status of family doctors, better incentives (medical service fees) l Have family doctor-run, community medical services, near patients’ homes

Set up multifaceted education systems

l Implement training, postgraduate programs at medical schools l Educate medical staff who support doctors l At school, teach children about NCDs, preventive care, adequate treatment

Collaboration, clarification of responsibilities

l Government ministries, offices, academia and people must cooperate l Define role/responsibility of government/municipalities in healthcare plan l Have performance index, milestones to set up PDCA cycle

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3. Increase Prevention Through a Centralized, Updated Vaccination Policy

Situation Vaccines offer the opportunity to significantly reduce disease burden, improve quality of life and, in many cases, provide economic benefits. As noted in the government of Japan’s Vision for the Vaccine Industry report, vaccines are recognized worldwide as a costeffective form of healthcare.

Although many of the latest vaccines are now also used in Japan, most are not covered by the national vaccination program. Either no public funding is available, or funding is only available for a limited period of time and with different levels of funding available in different regions. As a result, many individuals and their families must bear the financial costs involved.

This situation a major factor behind the emergence of an alarming access gap in Japan.

It is increasingly the case that financially secure individuals and families can afford to protect themselves from vaccine-preventable diseases, while less fortunate individuals and families living in certain regions cannot gain the benefit of important vaccines used widely around the world.

There is a high probability that public health action far exceeding the cost of vaccination would be required should there be an outbreak of infectious disease in Japan, since prevalence and transmission rates increase dramatically in under-protected populations.

Current Policy An immunization program based on the Preventive Vaccination Law exists in Japan, but no official national vaccination plan has been adopted by the Ministry of Health, Labour and Welfare (MHLW). Category I vaccines are provided almost free of charge and Category II vaccines receive partial public funding. However, no public funding is available for optional vaccines. Meanwhile, in an alarming trend, recently approved new vaccines are being placed in the optional vaccines category, which has no clear timeline or pathway for obtaining public funding.

Policy Changes in the Past Year: Improvements Seen, More Expected The MHLW Vaccination Committee has engaged in a comprehensive debate since 2009 on how vaccination should be implemented in Japan. In May 2012 the Vaccination Committee issued are report entitled “Reform of the Vaccination System (Second Proposal)” about the introduction of routine vaccination for seven optional vaccines. Part of the report was reflected in the revised Preventive Vaccination Law that was implemented on April 1, 2013.

The “Reform of the Vaccination System (Second Proposal)” report covered the following topics: 1. Purpose of reform.

2. Plan to comprehensively promote vaccination.

3. Adding new diseases and vaccines to the Preventive Vaccination Law. 4. Disease classifications in the Preventive Vaccination Law Requirement for classification and plan for the seven currently recommended vaccines: • Class 1 diseases: 1) to generate group immunity (Hib, pediatric pneumococcus, chickenpox, mumps); 2) to prevent significant social loss resulting from high fatality rates (HPV infection, hepatitis B.) May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 21

• Class 2 diseases: Focus on individual prevention (adult pneumococcus).

Responsibility for covering vaccination expenses.

Vaccine prices and other expenses.

Organization to evaluate and study vaccinations.

Various roles and responsibilities.

Systems for reporting adverse reactions and providing relief for recipients with reactogenicity.

10. Vaccination methods and records; providing of information.

11. Surveillance of infectious disease.

12. Promoting vaccine R&D; ensuring a supply infrastructure.

5.

6.

7.

8.

9.

The outline of the revised Preventive Vaccination Law is as follows: 1. Development of the plan to comprehensively promote vaccination 2. Adding new diseases and vaccines to the routine vaccination program (Hib infection, pediatric pneumococcal infection, HPV infection) 3. Legislation of the systems for reporting adverse reactions 4. Issues which are taken to the body to evaluate and study vaccinations While the ACCJ and EBC applaud the efforts to improve and increase access to vaccines, we remain concerned about the following points: • Of the seven vaccines recommended by the Vaccination Committee, it is not clear when routine vaccination for the remaining four vaccines (chickenpox, mumps, adult pneumococcal infection and hepatitis B) of the seven recommended vaccines will be able to start because of insufficient financial resources to pay for their use on a routine basis.

• In addition, no road map has been established to show how other Vaccination Committee proposals will be evaluated and implemented in the medical system.

• The cost of routine vaccinations have been generally borne by the local governments that conduct them. It is not clear how local governments will be able to secure sufficient funding to pay for the additional types of vaccination on an ongoing basis. Despite the potential public health benefits of the Vaccination Committee recommendations, local governments may not be able to pay for an increase in the types of vaccinations offered.

Recommendations • Access should be greatly improved to targeted vaccines—including those recommended by the World Health Organization—which should be provided for all vaccine-preventable diseases. To this end, a national mid- to long-term comprehensive vaccination plan should be formulated and a system should be established to evaluate its implementation.

• Full central government funding should be provided for all vaccines and a system should be put in place to secure the necessary funding.

• A clear pathway and timeline should be developed for assessing new vaccines for inclusion in the national vaccination plan immediately after their approval.

• Japan should harmonize its vaccine-related regulations and standards with globally accepted norms in order to facilitate the timely approval of vaccines used elsewhere around the world.

• Epidemiological research on the financial and social burden caused by infectious diseases should be increased and improved so that the burden can be better 22 | Lengthening Healthy Lifespans to Boost Economic Growth

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understood, the effectiveness of vaccines can be measured, and adverse events can be accurately assessed in a scientific manner.

Case Study: U.S. National Vaccination Plan In the United States, National Vaccination Plans have been formulated as 10-year vaccine and vaccination projects. The first plan was formulated in 1994 and it led to various successful outcomes based on strategies including vaccine research and development, safety, information provision, vaccination rates and supply, and promotion of global prevention. A plan for the next 10 years was formulated in 2010, built around five broad goals and 10 priorities.

Goals of the U.S. National Vaccination Plan 1. Develop new and improved vaccines.

2. Enhance the vaccine safety system.

3. Support communications to enhance informed vaccine decision-making.

4. Ensure a stable supply of, access to, and better use of recommended vaccines in the United States.

5. Increase global prevention of death and disease through safe and effective vaccination.

Priorities of the U.S. National Vaccination Plan 1. Develop a catalogue of priority vaccine targets of domestic and global health importance. (Goal 1) 2. Strengthen the science base for the development and licensure of new vaccines.

(Goals 1 and 2) 3. Enhance timely detection and verification of vaccine safety signals and develop a vaccine safety scientific agenda. (Goal 2) 4. Increase awareness of vaccines, vaccine-preventable diseases, and the benefits and risks of immunization among the public, providers, and other stakeholders. (Goal 3) 5. Use evidence-based science to enhance vaccine-preventable disease surveillance, measurement of vaccine coverage, and measurement of vaccine effectiveness. (Goal 4) 6. Eliminate financial barriers for providers and consumers to facilitate access to routinely recommended vaccines. (Goal 4) 7. Create an adequate and stable supply of routinely recommended vaccines and vaccines for public health preparedness. (Goal 4) 8. Increase and improve the use of interoperable health information technology and electronic health records. (Goal 4) 9. Improve global surveillance for vaccine-preventable diseases and strengthen global health information systems to monitor vaccine coverage, effectiveness, and safety.

(Goal 5) 10. Support global introduction and availability of new and under-utilized vaccines to prevent diseases of public health importance. (Goal 5)

References 1.

2.

MHLW Vaccination Committee report entitled “Reform of the Vaccination System (Second Proposal),” May 23, 2012. http://www.mhlw.go.jp/stf/shingi/2r9852000002b6r0.html.

U.S. Department of Health & Human Services website page on the National Vaccine Plan, accessed May 1, 2013. http://www.hhs.gov/nvpo/vacc_plan/.

May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 23

3. Japan’s Routine Immunization Vaccines WHO-recommended Vaccines for All Regions

Vaccines Routinely Given in Japan (✓)

BCG

✓

DTP (diphtheria, tetanus, pertussis)

✓

Polio

✓

Measles

✓

Rubella

✓

Haemophilus influenzae type b

=✓?

Pneumococcal (conjugate)

=✓?

HPV (human papilloma virus)

=✓?

Hepatitis B

×

Rotavirus

×

?=Implemented in April 2013

Source: Preventive Vaccination Law, Japan.

3. Vaccination System Reform: Recommended Implementation-evaluation System Is Not Established The MHLW Vaccination Committee’s “Reform of the Vaccination System (Second Proposal),” of May 23, 2012, considers: 1. Purpose of reform 2. Plan to comprehensively promote vaccination (provisional name) 3. Adding new diseases, vaccines to the Preventive Vaccination Law 4. Disease classifications in the Preventive Vaccination Law 5. Responsibility for covering vaccination expenses 6. Vaccine prices and other expenses 7. Body to evaluate and study vaccinations 8. Various roles and responsibilities 9. Systems for reporting adverse reactions to, and providing relief for recipients with reactogenicity 10. Vaccination methods and records; providing of information 11. Surveillance of infectious diseases 12. Promoting vaccine R&D; ensuring a supply infrastructure Source: Presentation material, 22nd MHLW Vaccination Committee, May 23, 2012.

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3. U.S. National Vaccine Plan: Goals n Vaccine and immunization program for a decade n First National Vaccine Plan released in 1994 n Second plan released in 2010 n Five broad goals, 10 priorities: Goal 1: Develop new and improved vaccines Goal 2: Enhance the vaccine safety system Goal 3: Support communications to enhance informed vaccine decision-making Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the United States Goal 5: Increase global prevention of death and disease through safe and effective vaccination Source: http://www.hhs.gov/nvpo/vacc_plan/

3. U.S. National Vaccination Plan: Priorities A. Develop a catalogue of priority vaccine targets of domestic and global health importance. (Goal 1) B. Strengthen the science base for the development and licensure of new vaccines. (Goals 1 and 2) Enhance timely detection and verification of vaccine safety signals and develop a vaccine safety scientific

C. agenda. (Goal 2)

Increase awareness of vaccines, vaccine-preventable diseases, and the benefits/risks of immunization

D. among the public, providers, and other stakeholders. (Goal 3)

Use evidence-based science to enhance vaccine-preventable disease surveillance, measurement of

E. vaccine coverage, and measurement of vaccine effectiveness. (Goal 4)

Eliminate financial barriers for providers and consumers to facilitate access to routinely recommended

F. vaccines. (Goal 4)

Create an adequate and stable supply of routinely recommended vaccines and vaccines for public health

G. preparedness. (Goal 4)

Increase and improve the use of interoperable health information technology and electronic health

H. records. (Goal 4) I.

Improve global surveillance for vaccine-preventable diseases and strengthen global health information systems to monitor vaccine coverage, effectiveness, and safety. (Goal 5) Support global introduction and availability of new and under-utilized vaccines to prevent diseases of

J. public health importance. (Goal 5)

Source: http://www.hhs.gov/nvpo/vacc_plan/

May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 25

4. Leverage the Full Value of Advanced In Vitro Diagnostic Tests

Situation Since the 1960s, advances in research and medical technology have led to the development of new diagnostic devices and measuring techniques that enable faster and more accurate diagnostic test results and provide healthcare practitioners with more useful information. Some of these new devices and techniques may cost more to perform than older tests, but they have become recognized around the world as essential in modern medical care because they contribute to improved treatment, faster recovery and greater peace of mind for patients. They can also lead to lower total healthcare costs because they can contribute to more successful treatment, faster patient recovery times, and shorter hospital stays.

Nevertheless, over the past 20 years, the full value of in vitro diagnostics (IVD) has not always been fully recognized in the Japanese healthcare system, particularly in the levels of medical reimbursement fees. As a result, Japanese patients have not always had timely access to the world’s most advanced diagnostic testing.1 In some cases, patients have undergone older diagnostic tests that are less expensive to conduct, but that may not be as accurate and speedy, or provide as much information as newer, more technologically advanced tests.

The advantages of laboratory testing, including genetic testing, for accurate diagnosis and preventive medicine have been increasingly recognized by healthcare practitioners. In the 2008, 2010 and 2012 medical fee revisions, some fees were increased in recognition of the value provided by laboratory testing. However, there is still room for improvement.

Current Policy In recent years, national medical care expenditure has grown, due to the increased health consciousness of the population, economic growth, the aging of society, and innovations in medical care technology. Since 1990, medical service fees for diagnostic testing have been steadily reduced, despite significant advances in medical technology, including automation that reduces labor costs while increasing speed and accuracy.

Completely new diagnostic testing methodologies that are more sensitive, more accurate, and provide more useful information have been developed. As one example, the fee for HIV testing has been steadily reduced, despite the introduction of increasingly advanced testing products that provide greater value. On the other hand, it can be very expensive to develop a new diagnostic testing agent, secure product approval, introduce it to the market, and maintain a system to ensure an uninterrupted supply and consistent high quality. As a result of not reflecting the value of improvements in diagnostic testing technology, Japan’s low reimbursement fees for diagnostic testing can undermine research and development of new, effective diagnostic testing technology. There are no incentives for innovation. Low reimbursement rates for diagnostic testing can also result in a “diagnostic lag” that can delay Japanese patient access to new diagnostic tests for several years after they are available in other developed countries.1 Among the IVD systems currently available in Japan, there remain differences in basic product performance, such as in the sensitivity and accuracy of reagents.

However, there are cases in which products with higher performance levels, in terms of accuracy and speed, receive the same medical service fees (number of National Health Insurance points) as products with lower performance levels. National Health Insurance 26 | Lengthening Healthy Lifespans to Boost Economic Growth

May 2013

reimbursement should be set in a way that reflects the true value of each diagnostic test and reagent, so that more effective (sensitive, accurate, speedy) ones are rewarded with higher fees.

One example can be found in the case of HIV/AIDS testing in Japan. Among advanced countries, the number of HIV/AIDS patients is rising only in Japan. Deficiencies in the existing testing system are a contributing factor in this rise. The testing system should be improved to allow testing of blood, tissue, and DNA samples at the appropriate time and in the most appropriate location. This means that some tests should be conducted quickly on site at the hospital or clinic, while other tests that are less urgent or require more sophisticated examination can be sent off-site to a testing laboratory. Such testing system reform should be conducted as a consistent national policy, rather than in different ways by different local governments.

Recommendations • Reduce the diagnostic lag through faster IVD product reviews. The period from submission until approval of innovative IVD technology in Japan is unnecessarily long. This increases development costs and slows patient access to the world’s most advanced (more sensitive, speedy, and accurate) IVD technology. The Pharmaceuticals and Medical Devices Agency (PMDA) should develop an action program to accelerate the review of new IVD products, similar to the five-year action program already in place for medical devices.

• Establish a medical reimbursement pricing system that better reflects the clinical value and quality of IVD tests. Laboratory tests should be conducted at medical institutions when speedy diagnosis helps improve medical treatment or shorten hospital stays.

An expert committee should be set up within the Central Social Insurance Medical Council that is capable of evaluating IVDs, similar to the existing expert committees for evaluating drugs and devices.

• Improve the overall quality of IVD tests available and commonly used in Japan. The medical reimbursement system should be revised to reflect differences in the clinical value of various IVD tests, so that healthcare practitioners have an incentive to use more advanced (sensitive, speedy and accurate) tests and so that manufacturers have an incentive to invest in research and development of new testing technology.

A system for regular reviews (reevaluation) by a third-party IVD expert organization should be introduced to assess these differences.

• Establish a consistent national medical screening system to promote screening and follow up for key diseases like HIV/AIDS, cervical cancer, hepatitis B and hepatitis C in a way that enables early detection and treatment of disease. The system should be consistent nationwide, rather than leaving it up to each local government to implement independently. The system should also recognize that, although some newer, more accurate and speedy IVD tests may cost more than older generations of the same test, they can often help to improve cost efficiency by increasing the success rate of treatment and by shortening hospital stays.

Reference 1.

L.E.K. Consulting LLC. 2010, 2011. IVD review time clock surveys conducted for the Japan Association of Clinical Reagents Industries and the American Medical Devices and Diagnostics Manufacturers Association’s In Vitro Diagnostics Committee www.jacr.or.jp and www.amdd.jp.

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4. Only 47% of IVD Products Approved Within 180-day Target Review Time Max: 1245 Days 900

Reviewer Time in Days

Max: 740 Days

800 700 600 500

Avg: 364

400

Avg: 247

300 200

Min. 238

100

Min:77

0

With (16 cases) Without (61 cases) Special Consultation Special No. of Consultation Cases With Without

PMDA Review Time

Within 180 Day Target

Minimum Days

Average Days

Maximum Days

No. of Cases

Achievement rate

238 77

364 247

740 1245

0 36

0 59

16 61

An action program to accelerate new in vitro diagnostic product reviews, similar to the program established for medical devices, should be established to provide more effective in vitro diagnostic products to clinical practitioners in a more timely manner.

Source: American Medical Device & Diagnostic Manufacturer Association “IVD Approval Cycle Time Clock Survey 2012”

4. Positioning of Laboratory Tests in the Healthcare Insurance System Total Medical Expenditures and In Vitro Diagnostic Testing Fees Total Medical Spending

IVD Testing Fee Level

• From 1990 to 2010, IVD testing fees were steadily cut to reduce costs.

• IVD testing fees increased 0.4% in 2012.

• The true value of the contribution of IVD testing to healthcare has not been reflected.

28 | Lengthening Healthy Lifespans to Boost Economic Growth

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4. 2010 Reimbursement Revision: Full Value of Improved HIV Tests Not Reflected RU[\XYV= MUU

EGC EEC ECC

D[\=NUYA OPS@D EYT=NUYA

OPS@DB OPSE

DJC DIC

FZT=NUYA

OPS=PVQ

DGC G\W=NUYA

OPS=LV

DEC DCC

DKKC DKKE DKKG DKKI DKKJ ECCC ECCE ECCG ECCI ECCJ ECDC

Although the quality has improved in each new generation of test, the value of the most advanced tests has not been reflected in insurance reimbursement points.

Test Kit Type

HIV-1

HIV-1, HIV-2

HIV-1, HIV-2 Group O

HIV-1, HIV-2 Group O, AntiCore Antigen Antibody

Antibody / Antigen Tested

Immunoglobulin G (IgG)

Immunoglobulin G (IgG)

Immunoglobulin G, M and A

Immunoglobulin G, M and A / Core Antigen

4. IVD Example: HIV Test Reimbursement Pricing Does Not Reward Innovation 1st Gen.

2nd Gen.

3rd Gen.

4th Gen.

Year

1986

1992

2002

2006

Detected Ab/Ag

IgG

IgG

IgG IgM IgA

IgG IgM IgA Core Ag

Target of diagnosis

HIV-1

HIV-1 HIV-2

HIV-1 HIV-2 Group O

HIV-1 HIV-2 Group O

Window Period

50 days

50 days

32 days

28 days

NHI points

220

220→190

160

120→130**

*HIV 1 Group O

**130 from 2008

New generations of HIV tests provide more information in a shorter time frame. However, old and new HIV Ab in vitro testing products with different performance receive the same reimbursement points.

May 2013

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5. Boost Collaboration Through Greater Use of Healthcare IT

Situation With the massive growth of the elderly population, coupled with the shortage and uneven distribution of physicians and other healthcare practitioners, Japan must consider a fundamental change in how healthcare services are delivered to its citizens. Healthcare information technology (IT) will be at the core of this change, producing improved efficiency, better outcomes, and higher quality of life. Many governments of other countries are investing heavily in healthcare IT, and are already gaining tangible benefits.

During the aftermath of the 2011 Tohoku triple disaster, many believe that it would have been much easier for doctors to provide, and patients to receive, emergency medical care if an efficient electronic healthcare record (EHR) system had been in place (instead of paper-based records that could be washed away). Based on this experience, and as the world’s leading IT economy, Japan has the potential to innovate and to become the global leader in healthcare IT. Since the introduction of the IT Basic Law in 2000, healthcare IT has been a priority for the government of Japan. As a result, 97 percent of large hospitals have implemented the so-called receipt-online system, a nationwide electronic billing system. However, the current process still requires some manual operations between organizations, and does not provide the full benefits of electronic throughput. Meanwhile, only 12.5 percent of hospitals nationwide have implemented the EHR system. Despite various governmentsponsored pilot projects for telemedicine, implementation has been relatively slow due to the lack of appropriate inventive models.

For that purpose, healthcare IT systems should not be designed only for individual hospitals, but with the idea of connecting hospitals (i.e. as a secondary “medical region”), to function as a component of the broader social infrastructure. Additionally, such infrastructure will not be sustainable if supplementary funding is limited to initial costs and do not cover running costs for maintenance, if productivity is not improved and if incentives are not provided through reimbursement. Both the installation and sustainable management of systems should be achieved. Furthermore, the government should proactively promote standardization of Japan’s healthcare IT based on global standards, with an eye to the continued introduction of global best practices into Japan. The need for efficiency and flexibility of large-scale systems that can be supported by many players in regional collaboration should also be taken into consideration. The government should introduce a comprehensive and holistic policy for the implementation and management of sustainable IT infrastructure that promotes adoption of global standards and incorporation of best practices from many players in an independent and prompt manner.

In September 2012, MHLW released a report entitled “Approach to an Adequate Framework for the Utilization and Protection of Medical Information”, that will be a framework for consideration of future regulations. METI also established the “Study Group on Medical Software Regulation” in October 2012 in order to discuss adequate rules that will promote industry growth.

According to a national survey of 5,000 Japanese people, 71.5 percent support and 2.9 percent oppose the introduction of electronic health records at hospitals and clinics in Japan.1 Among those who support the introduction, 75.6 percent said electronic health records would improve efficiency and reduce the cost of medical services while 60.6 percent said electronic health records could increase health safety by ensuring doctors 30 | Lengthening Healthy Lifespans to Boost Economic Growth

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are aware of allergies and other medicines a patient might be taking.1 The survey results also showed that 61 percent of Japanese believe that the Japanese government should promote telemedicine as a way to improve efficiency and access to medical services while only 8.3 percent said they are concerned about the accuracy and safety of telemedicine.1 Current Policy In 2009, the Japanese government introduced the Regional Health Revitalization Fund.

It is worth ¥235 billion, or an average of ¥2.5 billion across 94 regions, and is designed to be spent over the next five years to improve regional healthcare. Following the 2011 disasters, the government renewed its plan to increase to ¥12 billion funding for Miyagi, Iwate, and Fukushima prefectures.

On March 31, 2011, the Ministry of Health, Labour and Welfare issued an ordinance that eased restrictions and allowed telemedicine to be provided for use in nine chronic disease areas, including diabetes, cancer, and cerebrovascular disease. While the EHR system, together with regional healthcare collaboration, will form the fundamental infrastructure, accumulated data will open the path to improving emergency care, early detection and management of chronic disease, clinical decision support, research, and evidencebased medicine.

Recommendations • Develop a national healthcare IT plan.

• Make strategic investment plans for EHR and regional healthcare collaboration.

• Build incentive models to facilitate IT investment through reimbursement and funding.

• Ensure interoperability based on global standards to facilitate regional healthcare collaboration.

• Promote telemedicine.

• Implement special pilot projects in Tohoku for healthcare IT. • Promote external storage of healthcare information based on cloud computing, with adequate rules for privacy and security.

• Develop a national database to be used for evidence-based medicine.

• Encourage data mining and secondary use of healthcare data.

• Raise awareness, among healthcare providers and the members of the general public, regarding the benefits of using healthcare IT. • Develop new rules on medical software that promote the healthcare industry as well as the health of people.

• Introduce a legal framework for medical information, and Medical IDs based on global standards that take into account the balance between adequate protection and effective utilization of medical information.

Reference 1.

Health IT questions from the ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, November 2011.

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5. 71.5% of Japanese Back Introduction of Electronic Health Records at Hospitals, Clinics Q: Do you support or oppose the introduction of electronic health records at hospitals and clinics in Japan?

Support Oppose 71.5%

2.9%

73.7%

2.9%

69.4%

2.9%

65.9%

5.0%

69.3%

3.7%

68.5%

2.9%

70.6%

1.8%

76.6%

1.8%

76.2%

2.7%

73.6%

1.9%

]=Support/Agree ]=Slightly Support/Agree =]=Neither ]=Don’t know ]=Slightly Oppose/Disagree ]=Oppose/Disagree Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov, 2011.

5. Supporters of EHR System Expect More Efficiency, Safer Medical Service Q: Why do you support the introduction of an electronic health record (EHR) system at hospitals and clinics in Japan? (multiple answers)

(n=3,574)

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

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5. 50%+ of Japanese Support Telemedicine for More Efficient, Accessible Medical Service Q: Which of the following most closely corresponds to your views on telemedicine? (n=5,000)

]=I am slightly

concerned about the accuracy and safety of telemedicine

]=I am very concerned about the accuracy and safety of telemedicine

]=Do not know/have never heard of it

]=I strongly believe the government should promote telemedicine for better efficiency, access to medical services

]=I slightly believe the

government should promote telemedicine for better efficiency, access to medical services

]=I neither support nor

oppose the promotion of telemedicine

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

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6. Improving Home Medical Care for an Aging Society

Situation Promotion of home care will be one of the key healthcare policy issues in Japan for the next 10–15 years, given Japan’s rapidly aging society.1 According to a population forecast conducted by the Japanese government in 2012, the ratio of persons aged 65 and older as a percentage of the overall population will increase from 23 percent in 2010 to 30 percent and 40 percent by 2025 and 2060, respectively.2 Given elderly people’s increased need for medical services, this rise in their number could result in a shortage of beds in clinical centers and hospitals, and place considerable strain on the financial stability of the healthcare system in the absence of reforms. Given the pressing need to address this looming crisis, it is imperative that the Ministry of Health, Labour and Welfare (MHLW) now begins to formulate an appropriate policy response.

In a survey conducted in 2008 by the MHLW regarding terminal care in Japan, more than 63 percent of respondents expressed a desire to be taken care of in the home,3 an increase from 58 percent in 1998. In addition, a survey conducted in 2007 of elderly people by the Japanese Cabinet Office showed that more than 41 percent hoped to have nursing care at home.4 A key challenge for the Japanese government is in devising effective policies to address the above needs within the current structure of Japan’s health insurance system of 1) universal coverage, 2) benefit in kind, and 3) unrestricted access to medical facilities, even for low-income populations.

With the above in mind, the MHLW issued its Home Healthcare/Nursing Relief 2012 (Zaitaku Iryo/Kaigo Anshin 2012) plan.5 In response, the Japanese Nursing Association, the Japan Pharmaceutical Manufacturers Association, and other relevant healthcare associations have begun discussions on what respective actions and policies they need to take to expand home care in Japan. These deliberations have identified three high-level issues: 1) having home care medical treatment covered under Japan’s health insurance system; 2) expansion of approved medical interventions targeting home care and establishing the necessary infrastructure to access patient data from the home setting; and 3) developing a system to track the medical condition of patients in a timely fashion.

Under the new plan, the Japanese government has established the goal of transforming Japan’s healthcare system from one centered on providing health and nursing care through medical centers and hospitals, to one increasingly focused on providing in-home care to a rapidly aging population. To support this policy shift, the MHLW has stated that it will 1) implement cross-division budgeting within MHLW in order to leverage complementary activities; 2) clearly position home care under the Pharmaceutical Affairs Law; and 3) revise the reimbursement system to promote achievement of the plan.

The MHLW budgeted ¥3.5 billion (about $44 million) in FY2012 to support the implementation of the Home Health Care/Nursing Relief 2012 plan.5 Specifically, the MHLW has initiated in 2012 a project to promote home care and home nursing care that includes: 1) training of personnel in home care (¥109 million/about $1.3 million), 2) establishing a base of home care support sites (¥2.3 billion/about $29 million), and 3) improving and supporting medical care-related services based on the patient’s needs (¥1.1 billion/about $13.7 million). The American Chamber of Commerce in Japan (ACCJ) and the 34 | Lengthening Healthy Lifespans to Boost Economic Growth

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European Business Council in Japan (EBC) applaud these efforts by the MHLW to promote home care.

Current Policy While the ACCJ and EBC welcome Japan’s increased focus on improving home care, we believe the scope of the debate which, to date, has focused almost exclusively on the terminally ill should be significantly broadened. While it is critical to reform Japan’s healthcare system to improve treatment at home for the terminally ill, the ACCJ and EBC urge Japan to take this opportunity to include in its policy discussions the full range of treatments that can now be delivered safely in the home.

In short, the MHLW should move from a focus primarily on home care for the terminally ill to a definition that includes home care for the employed. In particular, the definition of home care in Japan should be expanded to include treatments that allow patients with non-terminal illnesses to continue to be productive workers by receiving treatment in their homes rather than in hospitals or clinics. By promoting increased use of home treatments across a range of healthcare needs, we believe that Japan can improve patient outcomes and quality of life, while addressing the financial sustainability of the healthcare system through more efficient allocation of tax revenues.

As leaders in developing and supplying innovative, life-saving pharmaceuticals and medical devices, ACCJ and EBC companies understand the particular challenges of creating products for home use. In particular, drugs and devices developed and designed for use in hospitals often require modification and testing to ensure ease and safe use by patients and caregivers. The modification of medical devices for home care use is neither evaluated nor reimbursed under Japan’s national health insurance pricing rules. Because of this, the health insurance reimbursement system does not provide incentives for manufacturers to develop products with functionality specific for home care use in Japan.

In addition, manufacturers often must establish infrastructure that allows data sharing among patients, physicians, nurses, pharmacists, and caregivers. The cost of developing such infrastructure is often not reimbursed at all or the reimbursement level is often below development costs. Separately, given the shortage of physicians, particularly in rural areas, and the need to ensure home devices are promptly and safely serviced, the MHLW will need to implement a system that expands the services that nurses and clinical engineers can provide in the home setting.

Recommendations In order to more efficiently and effectively meet the needs of Japan’s aging population, the ACCJ and EBC urge the MHLW to adopt the following recommendations to improve and expand access to home care in Japan: • Expand the scope and focus of home care from the terminally ill to include patients with chronic illnesses so as to support their continued participation in the work force.

• Incentivize manufacturers to invest in modifying medical devices for home care use by reimbursing these investments within the pricing rules and physicians’ fee system.

• Expand the range of medical interventions that nurses and clinical engineers can perform in the home.

• Include the maintenance fees for home care-related devices under the physicians’ fee system.

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References 1.

2.

3.

4.

5.

Ministry of Health, Labour and Welfare. Vital Statistics Data.

National Institute of Population and Social Security Research. January 2012. Future Population in Japan.

Ministry of Health, Labour and Welfare. Survey of Terminal Care.

Cabinet Office. 2007. Attitude Survey for Elderly Persons.

Home Healthcare/Nursing Relief 2012 Plan, Ministry of Health, Labour and Welfare, Home Healthcare Promotion Office, www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iryou/zaitaku/dl/anshin2012. pdf and www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iryou/zaitaku/index.html.

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7. Promote Health Through Food with Health Benefits

Situation As the Japanese population ages, public interest in the promotion and maintenance of good health has increased. Over the past decade, various food components have been demonstrated to have certain health benefits. These components come in various forms, including commodity foods and dietary supplements. Food for Specific Health Uses (FOSHU) and Foods with Nutrient Function Claims (FNFC) are categories of foods for which the Japanese government has approved claims of “health functions.”

From 2007 to 2011, the number of FOSHU products approved annually dropped 60 percent. The majority of approvals issued were for products of Japanese companies and few foreign companies have had their products FOSHU-certified. The FOSHU category, which is unique to Japan, may require an initial investment of up to $2.5 million. The high cost is often a major impediment for both foreign and small-to-medium-sized companies.

More than three quarters of companies with FOSHU approval are capitalized in excess of $12.5 million.

A food product that satisfies the FNFC standard for each vitamin and mineral is allowed to carry functional labeling corresponding to the relevant vitamins and minerals. Unlike the system of FOSHU product approval, FNFC standards are based on a system of ingredientsbased health claims, with health benefits that are transparent to the consumer.

There is also a substantial market for so-called health foods, which neither have FOSHU approval nor carry FNFC claims. It is estimated that the market share of so-called health foods is $14.27 billion, more than double that of the FOSHU category. Since these health foods make marketing claims based on health benefits that have not been proved, they often become the target of regulatory oversight and cause confusion among consumers.

As the so-called health food category grows, so does the need for transparency and consumer education. Ingredient-based health claims should be supported with scientific evidence that helps consumers make informed decisions.

Recommendations • Ingredients should support a healthy lifestyle based on scientific evidence. Ensure a process that is transparent, flexible, harmonized and inclusive.

• Use ingredients with functional claims. Ensure a process that is transparent, flexible, harmonized and inclusive.

• Ensure consumer safety, while using a transparent, flexible, harmonized and inclusive process.

• Transparent - consumers can make informed decisions.

• Flexible - manufacturers can cost-effectively meet consumer needs.

• Harmonized - non-tariff barriers do not hamper sales by overseas enterprises.

• Inclusive - companies of any size, in any location can participate.

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7. FOSHU and So-called Health Foods FOSHU: Foods for Specified Health Use Food category allowed to claim health functions of foods with approval from the government of Japan.

By 2011, 983 foods had been approved (figure 1).

The market size reached $6.42 billion in 2011 (figure 2).

• These foods often have become a target of regulatory oversight, since health foods carry copy claims that may imply health functions of foods without FOSHU approval.

• The market size was $14.27 billion in 2011 (figure 2).

Figure 1. Number of FOSHU Approvals Since 1993 1200 953983 883 827 755

1000 800 600 400 200 0

^_Total

627 569 475 398 329 289 222 171 58 100126 69 77 128 58 78 94 72 56 70 13 23 10 35 20 22 26 45 51 67 40 13 30

]_Each Year

93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 Source Japan Health Food & Nutrition Food Association. http://www.jhnfa.org/news-018.html

7. Difficult for Small- and Medium-sized Enterprises to Obtain F Approvals F approvals require more than $2.5 million initial investment, which is difficult for most SMEs billion 30.00

21%

FOSHU so-called “Health Foods”

20.00 5.11 10.00

1.63 8.19

0.00

7.03

2.82 9.31

12.25 13.65

7.82

15.94

8.43

6.82

6.42

21% 21%

79%

14.64 14.27 13.81

1997 1999 2001 2003 2005 2007 2009 2011 year

79% 79%

Fig.2 Market Sizes of FOSHU and so called Health Foods Reference UBM Media Co., Ltd. Kenkou Sangyou Shinbun 1/5, 2011, Research by Japan Health Food & Nutrition Food Association

Enterprises Capitalized 12.5 millions Enterprises Capitalized 12.5 millions

Enterprises Capitalized 12.5 millions Enterprises Capitalized 12.5 millions

Fig.3 Percentage of FOSHU Approvals vs.

Size of Enterprises as of 2011

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7. Current MHLW Policy for Food Health Claims

_

=

Need approval from Consumer Affairs Agency Self-declarations based on scientific If it satisfies FNFC evidence standard, applicable to For food factors other any food) For the 12 vitamins and than the 12 vitamins and 5 minerals 5 minerals

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8. Improve the Public Health Response to Influenza Pandemics and Other Biological Disasters

Situation As the World Health Organization (WHO) has warned, disease outbreaks are inevitable and often unpredictable events which offer special challenges considered to be “unique in all of public health.”1 Biological disasters, by their very nature, require a different kind of response than earthquakes or tsunamis.

Biological disasters can be natural (pandemic influenza) or man-made (terrorist attacks using biological agents such as anthrax or sarin). Many countries have extensive policies and guidelines in place to govern official behavior and communication needs in such events. Yet, time after time, when an outbreak occurs or is threatening to occur, even the most well thought out policies are not always sufficient. Many countries have found that there are significant shortfalls in the implementation of policies that looked good on paper.

The United States has conducted a series of “citywide response” exercises, known as “Top Officials” (or TOPOFF), throughout the last decade. For example, an outbreak of Yersinia pestis, the bacteria that causes plague, was simulated in Denver in 2000. A smallpox outbreak was simulated in Oklahoma City in 2002, and other simulations involving a range of diseases or biological agents have been held more recently in Chicago, New York and elsewhere. While these exercises have largely been considered successful, they have raised a number of questions about public health readiness. The ability to gain sufficiently rapid access to usable drugs and supplies from manufacturers or national stockpiles and the inability of some key players to communicate effectively with one another have been a particular concern.2 Effective communication has proven to be essential in safeguarding public health and limiting the impact of influenza pandemics and other biological disasters. The very nature of public communication in an outbreak is complex and fraught with both psychosocial and public health implications. The WHO communication guidelines3 focus on early announcement, transparency and trust building.

However, even countries that follow these guidelines find that confusion can quickly set in during an actual crisis, detracting from the effectiveness of the public health response.

This is especially true if different messages are delivered and received between different levels of government, among healthcare workers, by the media and community officials, and by the population itself.4 Such confusion can lead to inadequate healthcare for victims of a pandemic or other biological outbreak, as well as inadequate measures to protect the population that may as yet be unaffected.

Current Policy It is widely accepted that Japan is a world leader in many aspects of disaster preparedness.5 However, much of Japan’s preparedness efforts—by both governmental and non-governmental organizations—have been focused on natural disasters, such as earthquakes, tsunamis, typhoons, floods, and volcanic eruptions. This focus on natural disasters is both appropriate and necessary, as evidenced by the devastating 2011 Tohoku earthquake and tsunami. However, while Japan has in place policies and guidelines to protect public health in biological disasters, recent emergencies have indicated that there is considerable room for improvement in the implementation of those policies.

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Japan has experienced both natural and man-made biological disasters in recent decades—including a terrorist sarin attack on a Tokyo subway in 1994, outbreaks of avian influenza in 2005 and 2009, and an outbreak of swine flu in 2009.

Japan has a national policy in place for potential pandemic influenza outbreaks6 and Japanese infectious disease laws cover a range of public health situations, such as the need for quarantine and the notification of public health officials.

However, following the 2009 influenza outbreak, the Ministry of Health, Labour and Welfare convened a committee of 40 experts to review the nation’s response. That committee’s report (released in June 2010) identified dozens of deficiencies with current public health policies and the ways such policies are implemented.7 While the entire report merits careful reading, the most important recommendations might be overlooked in the large number of problems identified. In particular, many of the concerns expressed by the panel of experts are grounded in just a few major deficiencies. These include the failure to provide prompt and effective access to vaccines and anti-viral drugs, insufficient training of healthcare and community workers to address the medical and public health needs of both the sick and the healthy, and ineffective communications between and among the many governmental and non-governmental parties that are the key players in any outbreak.

Recommendations • Provide more comprehensive training for community and local public health officials and primary care physicians to recognize the initial characteristics of a pandemic or biological emergency.

• Develop clear guidelines for communicating with both patients and governmental organizations.

• Improve coordination and communication between the national government and prefectural and municipal government public health officials.

• Carefully assess the surge capacity of local healthcare providers (hospitals, physicians, nurses, pharmacists) to accept and care for substantially increased numbers of patients, and develop an appropriate plan for areas where such capacity must be expanded.

• Improve access to needed vaccines, anti-viral drugs and other necessary drugs, pharmaceuticals, equipment and supplies, including the development of strategic regional stockpiles as needed, and expedite clearance of foreign vaccines and antiviral drugs.

• Improve coordination with international bodies to adapt to reductions in the severity of virus strains.

• Update the government’s pandemic preparedness action plan to incorporate additional elements of the World Health Organization Outbreak Communications Guidelines and the U.S. Centers for Disease Control Crisis and Emergency Risk Communications Guidelines.8

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References

1. “Outbreak Communication Guidelines,” World Health Organization. 2005. www.who.int/infectious-disease-news/IDdocs/whocds200528/whocds200528en.pdf.

2. Gage, Larry, “Public Health and Bioterrorism”, Book chapter in Homeland Security Law Handbook, Government Institutes, 2003; see also Clarke, David, “Amid Terror Attack Warnings, Hospitals Say They Are Ready”, Congressional Quarterly Homeland Security—Local Response, 13 March 2003.

3. World Health Organization Outbreak Communication Guidelines, supra.

4. Abraham, Thomas, “Risk and Outbreak Communication: Lessons from Alternative Paradigms”, Bulletin of the World Health Organization, 2009; 87:604­–607; see also Fidler, David P., “Negotiating Equitable Access to Influenza Vaccines: Global Health Diplomacy and the Controversies Surrounding Avian Influenza H5N1 and Pandemic Influenza H1N1,” Public Library of Science Medicine Global Health Diplomacy Series, 4 May, 2010.

5. Rauhala, Emily, “How Japan Became a Leader in Disaster Preparation”, Time Magazine, 11 March, 2011.

6. “Pandemic Influenza Preparedness Action Plan of the Japanese Government”, Japanese Ministry of Health, Labour and Welfare, 2005, updated 2009. http://mhlw.go.jp/english/topics/influenza/pandemic01.html.

7. “Report of the Review Meeting on Measures Against Pandemic Influenza (A/H1N1),” 10 June, 2010. www.mhlw.go.jp/english/topics/influenza/dl/influenza.pdf. See also Fukuda, K, “2009 Influenza (H1N1) Pandemic: Lessons For Going Forward.” Presentation at the Forum of National Threats Workshop…, Global Challenges, Global Solutions”, 15 September, 2009.

8. World Health Organization Outbreak Communication Guidelines, supra; “Crisis and Emergency Risk Communication,” U.S. Centers for Disease Control and Prevention. www.bt.cdc.gov/cerc/overview.asp.

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8. Public Health Response to Influenza Pandemics and Other Biological Disasters “Pandemic flus -- like the 1918 flu and outbreaks in 1957 and 1968 -- often strike young, healthy people the hardest. This flu strain [H1N1] appears to infect an unusually high percentage of young people. The median age of patients is 17.”

- The New York Times, “Swine Flu (H1N1 Virus)” 4 January 2010

“It is necessary to further strengthen countermeasures at the onset of an outbreak, and to develop a system to collect/ provide /communicate/disclose information in the pre-pandemic phase. For this purpose, it is essential to strengthen the institutional capacity and human resources of the Ministry and the National Institute of Infectious Diseases (NIID;…Particularly, the NIID should be better organized and staffed by reference to the US Centers for Disease Control (US-CDC) and other international organizations in charge of infectious diseases.”

—Report of the [Japan] Review Meeting on Measures Against Pandemic Influenza (June 10, 2010)

8. WHO Response to Influenza Pandemics and Other Biological Disasters

The WHO Outbreak Communications Guidelines describe seven steps for National Public Health Authorities: • Assessment • Coordination • Transparency • Listening during Outbreaks • Communication Evaluation • Constructing an Emergency Communication Plan • Training

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9. Prevent Chronic Diseases Through Tobacco Control

Situation It has been scientifically proven that tobacco smoking increases the risk of many diseases—such as cancer (including lung cancer), myocardial infarction, stroke, and chronic obstructive pulmonary disease—and that abstinence from tobacco can decrease these risks and lead to health improvement. The World Health Organization (WHO) states that tobacco smoking is the single largest preventable cause of disease.1 Tobacco smoking is classified in the category of “mental and behavioral disorders due to psychoactive substance use” according to the ICD-10,2 because it is difficult for most smokers to stop smoking by themselves and many require support in overcoming the addiction.

Tobacco smoking is now recognized as an addiction in Japan and, since 2006, medical service fees for smoking cessation treatment have been classed as “nicotine addiction management” fees.3 The integrated results of three large-scale cohort studies in Japan show that, among 1,084,000 deaths in 2005, the number of men, women and the total population who died of any disease related to smoking is estimated to be 112,000, 19,000, and 131,000, respectively.4 Furthermore, it has been scientifically verified that second-hand smoke increases the risk of various diseases and disorders, as well as death from serious diseases. One effective method of reducing the health risks is banning indoor smoking to prevent exposure to second-hand smoke. The WHO recommends that every indoor workplace and all public spaces be made smoke-free. A non-smoking environment in indoor areas is also useful for smokers who want to stop smoking. It has been reported that a policy of smoke-free air in every workplace could reduce the absolute prevalence of smoking.5 The 2011 National Health and Nutrition Survey reported that the overall prevalence of smoking among Japanese adults is 19.5 percent. Meanwhile, the rate of smoking among men decreased from 46.8 percent in 2003 to 32.2 percent in 2011, and the rate of smoking among women has remained somewhat steady, at 8.4 percent in 2011. However, the prevalence of smoking among men below the age of 50 still exceeds 40 percent and the rate among women below 40 is in the range of 13–14 percent.6 According to one survey, the economic loss per year due to tobacco smoking is estimated at ¥1.62 trillion in terms of excess medical costs for smokers, ¥0.14 trillion in excess medical costs for passive smokers, ¥0.48 trillion in excess nursing care costs, ¥3.93 trillion in losses related to the labor force, and ¥0.19 trillion due to fires or extra cleaning in facilities/interiors. This adds up to a total annual loss of ¥6.36 trillion.7 A national public opinion survey on passive smoking in the workplace conducted among 8,000 indoor workers in Japan in 2012 showed that 64 percent would support a legally mandated smoking ban for indoor worksites and that only 16 percent say that passage of such laws would have a negative impact on their business. Some 58 percent of workers say they are worried about the impact of passive smoking on their health, while 81 percent of workers say they want a worksite that is either smoke-free or completely segregated so that smoke does not leak out of smoking rooms.8 Current Policy In May 2003, the government of Japan implemented Article 25 of the Health Promotion Act to eliminate second-hand smoking in public spaces. The law does not stipulate any 44 | Lengthening Healthy Lifespans to Boost Economic Growth

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penalties, specifying only good faith efforts, but it has gradually promoted a voluntary non-smoking movement. Further, with Japan’s June 2004 ratification of the WHO Framework Convention on Tobacco Control, which came into force internationally in 2005, efforts to adhere to the treaty—including the introduction of the Taspo system to prevent purchases of tobacco by minors—have been implemented in Japan.

National health insurance coverage for the treatment of nicotine addiction through smoking cessation programs has been approved since 2006. The coverage requirements are set according to the following formula: daily number of cigarettes smoked × the number of years of smoking. However, because coverage includes only persons for whom this formula totals more than 200, most young smokers are excluded.

In December 2009, a large package of tax revisions stipulated that the tobacco tax rates should be increased in the future to inhibit tobacco consumption in order to improve public health. Consequently, the tobacco tax was raised on October 1, 2010. As a result, in 2011 the number of cigarettes sold decreased 11 percent year on year, while their value increased 16 percent year on year to ¥4.06 trillion.9 Policy Changes in the Past Year: Slight Improvement In the Basic Plan to Promote Cancer Control approved by the Cabinet in June 2012, the first numerical targets adopted were aimed at reducing the national smoking rate to 12 percent by 2022. Further, in stage two of the Healthy Japan 21 health promotion goals that were announced in 2012, the following targets were set to limit second-hand smoke inhalation by reducing smoking in:10 • Government buildings, from 16.9 percent in 2008 to 0 percent by 2022 • Medical institutions, from 13 percent in 2008 to 0 percent by 2022 • The workplace, from 64 percent in 2011 to 0 percent by 2020 • In restaurants and bars, from 50.1 percent in 2010 to 15 percent by 2022 In December 2011, the Japanese Cabinet approved a draft amendment to the Industrial Safety and Health Act that would have required business owners to either adopt an indoor smoking ban for their workplaces, or protect workers from passive smoking by separating smoking areas from places where non-smokers work. In August 2012, the language in the draft amendment was weakened to require employers only to make efforts to protect workers from second-hand smoke, but even the weakened draft did not pass before the close of the parliamentary session in November 2012.

Recommendations • To protect workers from the health risks of second hand smoke, parliament should revise the Industrial Safety and Health Act to require employers to make efforts to protect workers from second-hand smoke either by enacting an indoor workplace smoking ban or by separating smoking and non-smoking spaces by creating smoking rooms from which smoke does not leak.

• An additional tobacco tax increase should be considered as a way to protect people’s health, while also taking into account the potential impact of the expected consumption tax increases in 2014 and 2015.

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References

1. World Health Organization report on the global tobacco epidemic, 2011.

2. World Health Organization. International Statistical Classification of Diseases and Related Health Problems, 10th edition (ICD-10).

3. Ministry of Health, Labour and Welfare, the latest information on tobacco at www.health-net.or.jp/tobacco/front.html.

4. Katanoda K, et al. “Population attributable fraction of mortality associated with tobacco smoking in Japan: a pooled analysis of three large-scale cohort studies,” J Epidemiol. 188:251–264, 2008.

5. Fichtenberg CM, Glantz SA. “Effect of smoke-free workplaces on smoking behavior: Systematic review,” BMJ 325:188–191, 2002.

6. Ministry of Health, Labour and Welfare. 2009. National Health and Nutrition Survey.

7. Institute for Health Economics and Policy. “Study of anti-smoking measures: Estimate of costs resulting from smoking,” March 2010.

8. Japan-wide survey of 8,000 indoor workers on passive smoking in the workplace, conducted

by Johnson & Johnson K.K. Consumer Company, released July 19, 2012. www.jnj.co.jp/group/ press/2012/0719/index.html; www.jnj.co.jp/group/press/2012/0719/pdf/20120719.pdf.

9. Tobacco Institute of Japan, materials released on January 27, 2012.

10. Reference material for the promotion of Healthy Japan 21 (stage two) by the Regional Public Health Promotion Nutrition Subcommittee, Health Sciences Council, July 2012.

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9. 61.7% of Japanese Adults Support October 2010 Tobacco Tax Increase Q: What do you think about the October 2010 tobacco tax increase?

Overall (n=5000)

48.2

13.5

Male (n=2401)

48.9

12.2

Female (n=2599)

47.5

14.7

0%

20%

40%

16.9

15.1 2.8 6 18.7

60%

]=Support/Agree ]=Slightly Support/Agree ]=Neither ]=Don’t Know ]=Slightly Oppose/Disagree ]=Oppose/Disagree

3.9 5.8

5

11.7 15

5.6 8.6

80%

Gender Both

Support 61.7%

100%

Oppose 17.5%

Male

61.2%

21%

Female

62.2%

14.2%

Source: “ACCJ Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan.” Nov. 2011 survey sent to 5,000 members of the Japanese public, covering a cross-section of men and women across all regions and age cohorts.

9. 69% of Adults Backing Hike in Tobacco Tax Cite Health Impact of Passive Smoking Q: Why do you support/agree with, or slightly support/agree with, the October 2010 tobacco tax increase? (Asked of respondents who supported or agreed with the previous question.)

Source: “ACCJ Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan.” Nov. 2011 Survey of 5,000 members of the Japanese public.

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Lengthening Healthy Lifespans to Boost Economic Growth | 47

9. 64% Would Support, 16% Oppose a Legally Mandated Indoor Worksite Smoking Ban Q: What would you think if the national or local governments legally required a complete smoking ban in all indoor workplaces and public spaces, including restaurants, bars and taxis, to protect the health of non-smoking workers?

Source: Japan national survey on passive smoking in the workplace of 8,000 indoor workers by Johnson & Johnson K.K. Consumer Company, released on July 19th, 2012.

9. 70% of Indoor Workers: Legal Smoking Ban Would Not Negatively Impact Business Q: How would your business be impacted if national or local governments legally required a total smoking ban in all indoor workplaces and public spaces, including restaurants, bars and taxis, to protect the health of non-smoking workers?

Source: Japan national survey on passive smoking in the workplace of 8,000 indoor workers by Johnson & Johnson K.K. Consumer Company, July 2012.

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10. Increase Early Detection Through Comprehensive Eye Exams

Situation In Japan, based on Japanese medical standards, 1.64 million people are visually impaired and 188,000 are blind. Of the total, 72 percent are aged 60 or over. According to a September 2009 study released by the Japan Ophthalmologists Association (JOA), vision problems result in estimated social costs and labor productivity losses of ¥8.8 trillion per year.1 The JOA estimates that by 2030, the number of people with vision problems and the resulting social costs will have increased roughly 25 percent from the 2009 level.1 Comprehensive eye exams by ophthalmologists are important for far more than just determining the prescription for vision correction. They are also important for the detection and diagnosis of eye diseases, including glaucoma, diabetic retinopathy, macular degeneration, and eye coordination problems that can cause a range of conditions from blurry vision to blindness.

Early detection and timely treatment are crucial to prevent visual impairment and progression of conditions leading to blindness, especially for children under the age of six and adults aged 40 and over. Comprehensive eye exams by ophthalmologists are also valuable for detecting signs of systemic health problems that show early warning signs in the tiny blood vessels and optic nerves in the eyes, including hypertension, diabetes, high cholesterol, stroke, and heart disease.

A recent national survey of 5,000 adults in Japan showed that more than half had received an eye exam in the previous year, when buying glasses or contact lenses, at an annual health check, or when renewing their driver’s license. However, 33 percent of adults in Japan had not had any type of eye exam in the previous year. Only 17.7 percent of people in the 70–79 age group had received a fundoscopic eye examination using pupil-dilating drops, with the percentage dropping to only 6.5 percent for people in the 40–49 age group. Some 16.6 percent of parents with children aged four and up said their children had not received an eye exam before entering elementary school.2 In Japan, the School Health and Safety Act requires the boards of education of local governments to conduct health checkups at the time children begin elementary school, while related regulations prescribe that the vision strength of both eyes be checked, using a vision chart based on international standards, and that checks be conducted for potential abnormalities. A survey of local boards of education conducted by the JOA, indicated that while 172 of 190 boards (90.5 percent) were conducting the required eye exams, 17 cities and towns in Osaka, Kanagawa and Fukuoka prefectures were not. Only 46.8 percent of municipal governments were conducting the checkups by eye doctors.3 Although many countries around the world legally require patients purchasing contact lenses to have a prescription showing that they have had their eyes checked by a doctor, in Japan no such legal requirement exists. Thus, there are reports of serious eye damage, caused by inflammation of the cornea and corneal ulcers, resulting from improper care of contact lenses, the use of contact lenses for excessively long periods, and insufficient explanation of such risks to patients at the time of purchase.4 Current Policy The Japanese government’s Healthy Japan 21 policy goals do not include any goals specifically related to eyes or vision health.5 By contrast, the U.S. Department of Health May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 49

and Human Services program, Healthy People 2020, comprising 10-year goals and objectives for health promotion and disease prevention, includes eight categories related to eyes and vision.6 Although more than 60 percent of adults in Japan undergo an annual health checkup and many of them receive some kind of eye exam, comprehensive eye exams including dilation by ophthalmologists are not currently mandatory in the annual special health screenings (tokutei kenshin).

Recommendations As a way to promote public health, the following goals for vision health should be included in the Japanese government’s health policy: • Increase the proportion of preschool children aged five years and under who receive vision screening to 100 percent.

• Ensure that contact lenses are sold based on the guidance of an eye doctor. Reduce potential eye health problems related to contact lenses by ensuring that users have periodic eye exams and are provided information about the risk of eye health problems resulting from improper use.

• Create a government program to promote adult eye health. Reduce visual impairment due to diabetic retinopathy, glaucoma, macular degeneration, refractive error, and cataracts by increasing the proportion of adults who have a comprehensive eye examination—including with dilation of the pupil—conducted by an eye doctor every two years. In particular, make the provision of comprehensive eye exams mandatory for people aged 40 and over as a way to promote early detection of eye health problems related to diabetes, for which early warning signs can be detected in the tiny blood vessels and nerves visible in the eye.

References

1. “¥8.8 Trillion of Social Loss Induced by Vision Disorders,” report published by the Japan Ophthalmologist Association (Shadan Hojin Nihon Ganka Ikai), September 2009.

2. “National Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan,” published by the American Chamber of Commerce in Japan, November 2011. www.accj.or.jp.

3. “2008 Survey on the State of Health Checkups Conducted by Preschools and at the Time of Entering Elementary School,” Ophthalmology Japan, edition 80, issue 9, Japan Ophthalmologist Association School Health Section.

4. “Notice on Improving the Provision of Information about Proper Usage of Contact Lenses,” Japan Ministry of Health, Labour and Welfare, Pharmaceutical and Food Division, July 18, 2012 (Yakushoku Hatsu 0718 Dai 15 Go).

5. Healthy Japan 21. www.kenkounippon21.gr.jp/.

6. U.S. Healthy People 2020. http://healthypeople.gov/2020/topicsobjectives2020/.

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10. Value of Eye Exams for Health Many diseases can be detected in a comprehensive eye exam by a doctor, even when patients cannot notice symptoms themselves.

Early detection and timely treatment is crucial to prevent visual impairment and progression of conditions leading to blindness.

Diseases of the Eye

l Early signs of eye coordination and focus problems need to be detected when children are 3–5 years old in order to treat them and prevent vision loss. l Early detection of glaucoma, diabetic retinopathy and infection is key to prevent vision loss. l Cataract surgery is effective in restoring vision.

Cataract

General Health Problems

l Early signs of diseases like hypertension, diabetes, high cholesterol, stroke, and heart disease show in tiny blood vessels and optic nerves at the back of the eye before patients can notice symptoms. l Early detection gives the patient a chance to reduce risk factors through medication, exercise, or diet.

Leaking blood vessels in patient with diabetic eye disease

10. Growing Economic Cost of Vision Problems Could Be Reduced l 1.64 million people are visually impaired or blind, resulting in estimated social costs of ¥8.8 trillion per year. l By 2030, the number of people with vision problems and the resulting social costs are expected to increase by roughly 25%. ¥1.58 Tril.

Lower Productivity, Extra Care Costs

¥5.86 Tril.

Lower Quality of Life

¥1.34 Tril.

Direct Economic Cost

Source: Shadan Hojin Nihon Ganka Ikai, Sept. 2009.

Note: 1.44 million people have “low vision” and 188,000 are blind. Of the total, 72% are 60 or over.

May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 51

10. Low Eye Exam Rates for Children Q: Did your children have an eye exam before entering elementary school? (2,934 respondents with children aged 4 or older)

1.3%

l 16.6% of parents said their child did not have an eye exam before entering elementary school. l 53.7% of parents were not sure if their child had an eye exam before entering elementary school.

] Yes, my child did have an eye exam ] No, my child did not have an eye exam ] I am not sure whether my child had an eye exam ] Other

28.4% 53.7% 16.6%

Source: ACCJ National Opinion Survey on Prevention and Wellness in Japan, November 2011.

10. Eye Tests Received By People Aged 40+

Q: Which of the following types of eye exams have you had in the past year? (Multiple answer)

Source: ACCJ National Opinion Survey on Prevention and Wellness in Japan, November 2011.

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11. Promote Oral Care to Prevent Periodontal Disease and Dental Caries

Situation Dental health is important not only for chewing food, but also for maintaining a good quality of life through such activities as enjoying pleasant meals or conversation.

Recent scientific evidence suggests that oral health abnormalities also play a role in the deterioration of general health.1 Reflecting the public’s increasing oral health consciousness, the results of the dental disease investigation—conducted once every six years by the Ministry of Health, Labour and Welfare (MHLW)—indicate that the number of persons brushing their teeth two or three times a day has been increasing yearly.2 But despite oral hygiene awareness and the improved tooth-brushing habits of the Japanese, more than 70 percent of the population aged 20 or over have periodontal disease. Moreover, the 2011 rates for young adults and elderly populations was higher than in 2005.2 In the United States, as a result of a recommendation by the American Dental Association (ADA) on interdental cleaning and the use of mouthwash as adjuncts to tooth brushing, the usage rate of interdental cleaning tools and mouthwash is higher than that in Japan.

The difference in daily dental self-care is considered to be one reason for the apparent differences between the United States and Japan in terms of the number of natural teeth remaining in the elderly.3, 4 Current Policy The Japanese government’s Healthy Japan 21 policy goals set dental policy objectives for the prevention of dental loss and the prevention of dental caries and periodontal disease, which can cause dental loss. In October 2011, the MHLW summarized its final evaluation. It states that, of the 13 items evaluated with indicators, five items reached their goals: there were more persons in their sixties with at least 24 natural teeth, and in their eighties with 20 natural teeth; there was an increase in the ratio of persons who had received regular dental checkups at least once in the previous year; there were seven items showing a trend toward improvement; and one item had remained unchanged.5,6 This improvement is thought to be due, in part, to the benefits of fluoride and health promotion campaigns that resulted in positive behavioral changes (such as greater usage of floss and mouthwash).

In response to these results, the MHLW reviewed the basic policy of Healthy Japan 21 (stage two), fully revising it in July 2012 to promote a general improvement in public health, and setting up new target values for dental and oral health to 2022. In addition, in August 2011 the Dental and Oral Health Promotion Law was promulgated, which includes the recommendation that regular dental checkups be conducted.

Rather than simply treating dental caries or areas affected by periodontal disease, many dentists have begun to focus on oral checkups, evaluating the presence of dental caries and periodontal disease, and to perform regular cleaning to maintain oral health. However, according to the current health insurance reimbursement system, the compensation for early intervention and patient education is lower than that for treatment.

In 2010, based on a proposal from the National Dental Conference for Support of Motivation in Life, together with the aggressive use of the mass media, progress was made in promoting public awareness regarding preventive dentistry. The public has been May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 53

broadly and thoroughly informed of the significance of the 80/20 Healthy Long-Lived Society campaign.

Progress in the Past Year: Slight Improvement The updated version of Healthy Japan 21 shows that the MHLW announced 10 new oral care-related goals in July 2012.7 Recommendations • To encourage the prevention of periodontal disease, promote instruction in interdental cleaning (interdental brushing and dental flossing), based on the individual’s oral condition, the use of chemical plaque control agents (mouthwash), and the provision of conventional coaching in tooth brushing by dentists and dental hygienists.

• To promote the prevention of gingivitis, which is frequently observed in the young population, add to the coaching in tooth brushing, that is part of school children’s oral hygiene education, instruction in interdental cleaning (interdental brushing and dental flossing).

• Under the health insurance reimbursement system, provide higher compensation incentives for dentists to educate their patients in the prevention of dental caries and periodontal disease.

• The use of fluoride should be promoted by using it in more oral care products (such as quasi-drug mouthwash) in addition to toothpaste.

References

1. Japan Dental Hygienists’ Association. 2009. Guideline for periodontal disease and general health— physical health begins with prevention of periodontal disease. pp. 14–27.

2. Ministry of Health, Labour and Welfare. Investigation of the actual status of dental disease in 2011.

3. American Chamber of Commerce in Japan. 2011. National survey on prevention, early detection and the economic burden of disease in Japan; and American Chamber of Commerce in Japan. 2012.

Questions concerning oral health, nationwide (n=5,000).

4. 8020 Promotion Foundation. International oral health data bank (international comparison of substantial investigations of dental diseases of Japan and other countries).

5. 8020 Promotion Foundation www.8020zaidan.or.jp. Healthy Japan 21 www.kenkounippon21.gr.jp.

6. Ministry of Health, Labour and Welfare, Office for Life-Style Related Diseases Control, General Affairs Division, Health Service Bureau. 2011. Healthy Japan 21. Final evaluation (October 13).

7. Health Sciences Council, Regional Public Health Promotion Nutrition Subcommittee. 2012. Reference material for the promotion of Healthy Japan 21 (stage two).

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11. Brushing Frequency Has Risen, but Use of Mouthwash, Interdental Cleaning Are Low Frequency of Teeth Brushing in 日本人の歯磨き回数 Japanese Population

60 50 40

33

30

45

48 49 48

1993 29

26

22 16

20 10 0

1

1

1

4

1

+hzltc Not brushing teeth

19

21

1999

25

2005 2011

3

3

2

a+i Occasionally brushing teeth

Country

a day Once

Two times a day

times a day Three

Source: Investigation of Actual Status of Dental Disease 2011, MHLW

Teeth Brushing (twice a day)

Interdental Cleaning Tool

７３％１

７６％４

Mouthwash

４３％２

３３％３

７４％４

６３％４

1. Results of investigation of actual status of dental disease in 2011 (MHLW; n=4253) 2. The frequency of using interdental cleaning device is at least 2 times every week and regular checkup is at least once every year . From “ACCJ Survey concerning Prevention, Early Detection, and Economic Burden of Disease” (2011, n=5000) 3. Investigated by Johnson & Johnson in 2009. Nationwide (n=1881). Having used once or more in the past 1 month (%).

4. WHO International Collaborative Study II in 1997.

11. Further Measures Required for Periodontal Diseases Centering on Middle-aged and Elderly People More than 70% of people aged 20 or over still affected by periodontal disease; ratio of the affected elderly is rising.

100 90 80 70 60 50 40 30 20 10 0

80 77

75 72

86

86 83

82

82 84 67

57 60

47

5-9

20 15

2005 2011

10-19

20-29

18.1 14.5

30-39

17.7 12.7

10

40-49

50-59

60-69

70-79

16.8

17.2

15.1

10.1

80-

Investigation of actual status of dental disease 2011 conducted by MHLW

9.8

12.8

5 0 U.S. | ~

May 2013

56

35 36

Remaining number of teeth in the elderly in the U.S. is apparently higher than that in Japan.

Number

of teeth

73

65-­‐69

Japan

70-­‐74

75-­‐79

8080 or over

Total

Source: International oral health data bank, 8020 Promotion Foundation

Lengthening Healthy Lifespans to Boost Economic Growth | 55

11. Many Oral Care Goals of the Healthy Japan 21 Campaign Were Achieved Goals

Subject

Baseline

Interim Result

Goal

Final Grade

Increase in infants without dental caries (aged 3)

National average

59.5%

77.1%

JC =or higher

Increase in infants receiving fluoride application on teeth surface (aged 3)

National average

39.6%

64.6%

HC =or higher

Decrease in infants having habit of frequently eating or National average drinking sweetened food/beverage as snacks (aged 1.5)

29.9%

19.5%

DH =or lower

Decrease in average dental caries per person (aged 12) National average

2.9 teeth

1.3 teeth 1 tooth or less

Increase in use of fluoride-containing dentifrice among school children Increase in school children who receive individual interdental cleaning training (in the past 1 year) Decrease in advanced periodontitis (incidence) Increase in use of interdental cleaning tools (rate of users) Increase in people who have their own teeth Increase in people who receive regular dental scaling or cleaning of dental surface (in the past year) Increase in people who receive regular dental examination (in the past year)

National average

45.6%

86.3%

KC =or higher

National average

12.8%

20.0%

FC =or higher

Age 40

32.0%

18.3%

EE =or lower

Age 50

46.9%

27.6%

FF =or lower

Age 40_

19.3%

44.6%

HC =or higher

Age 50

17.8%

45.7%

HC =or higher

11.5%

26.8%

20 =or higher

44.1%

56.2%

HC =or higher

Age 60

15.9%

43.0%

FC =or higher

Age 60

16.4%

36.8%

FC =or higher

20+ teeth at age 80 24+ teeth at age 60

Source: Final Evaluation of "Healthy Japan 21" by Office for Life-Style Related Diseases Control, MHLW, October 2011.

11. New Oral Care Policy Goals in the Revised Healthy Japan 21 (Targeting 2022) Goals Increase in people in their 60's with good chewing ability

Subject

Baseline 2022 Target

60s

73.4%

80%

Increase in 80-year-old people with 20+ natural teeth

Age 80

25.0%

50%

Increase in 60-year-old people with 20+ natural teeth

Age 60

60.2%

70%

Increase in the ratio of people with no missing tooth

Age 40

54.1%

75%

20s

31.7%

25%

40s

37.3%

25%

60s

54.7%

45%

Age 3

6

23

Age 12

7

28

Age 20+

34.1%

65%

Decrease in people in their 20s with observations of inflammation in the gum Decrease in people in their 40s with observations of inflammation in the gum Decrease in people in their 60s with observations of inflammation in the gum Ratio of prefectures (states) where the ratio of 3-year-old infants without dental caries Increase in prefectures (states) where average number of dental caries per 12-year old child is less than 1 Increase in the number of people who received dental checkup in the last year (20 year old or older)

Source: Healthy Japan 21 (Second stage), Regional Public Health Promotion Nutrition Subcommittee, Health Sciences Council, July 2012.

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12. Increase Sleep Apnea Syndrome Screening

Situation Early detection is crucial to the health and wellbeing of patients suffering from sleep apnea syndrome (SAS). In FY2012, the number of patients with SAS in Japan was more than three million (a prevalence of 2–4 percent of adults), of whom only 250,000 (about 8 percent) were undergoing treatment.1 That means there is a large pool of latent patients, who are unaware of their condition and do not recognize the symptoms. SAS not only disrupts a person’s sleep, causing daily drowsiness, but also contributes to serious cardiovascular disease, such as hypertension, heart failure, stroke, and heart arrhythmia.

Several studies have demonstrated that the cumulative survival rate of SAS patients who do not receive proper treatment is significantly lower than that of those who do.2 While the treatment offered to patients diagnosed with SAS in Japan is in line with that of other developed nations, efforts to bring latent patients to sleep labs for detection are insufficient. Undetected and untreated SAS takes a heavy toll on society. It is estimated that untreated SAS patients cause seven times more traffic accidents than persons who are not suffering from the syndrome.3 In Japan, a major incident attributed to SAS occurred in 2003, when a bullet train driver dozed off at the controls.

The number of patients with SAS who are undergoing continuous positive airway pressure (CPAP) treatment in the United States currently stands at between three and five million, or about 20 to 30 times more than in Japan.4 This greater number in the United States is due to the more frequent diagnosis of sleep disorders in that country. It is estimated that there is about one sleep lab bed for every 10,000 persons in Japan, while there are five to 10 sleep lab beds for every 10,000 persons in the United States. Also, physicians in the United States have a greater incentive for conducting SAS detection tests where the reimbursement is typically in the range of $1,000 to $1,500. Given the severity of the comorbidities of SAS, preventing and treating it is an investment in public health.

Current Policy At present, the Ministry of Health, Labour and Welfare (MHLW) provides reimbursement for SAS testing via full polysomnography (PSG) and simplified portable PSG (without electroencephalography). However, the national health insurance reimbursement amount for full PSG is only ¥33,000 per test (requiring one night in hospital) and does not cover the room charge and the staffing cost of sleep laboratory technicians. This low level of reimbursement does not provide an adequate incentive to physicians. Meanwhile, the significant out-of-pocket costs for patients means that affordability reduces access to SAS testing.

In terms of national insurance coverage, CPAP treatment can be prescribed in the United States and major countries in Europe for patients with an apnea-hypopnea index (AHI) of more than five. By contrast, the treatment can be prescribed in Japan only when the AHI is more than 20. Therefore, CPAP treatment cannot be offered to many patients in Japan who would be able to receive it in other countries.

Annual health screenings provide an important opportunity to detect lifestyle diseases while they are in their early stages. Untreated, SAS can lead to many lifestyle diseases.

To date, in Japan there has been only one official government statement in support of SAS screening. Issued in 2003 by the Ministry of Land, Infrastructure, Transport and Tourism, it recommends the screening for professional drivers. There has been no statement or May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 57

recommendation for other workers. Many medical practitioners consider SAS screening to be necessary for adult males, of whom 20 percent have the syndrome.5 In addition, the decrease in female hormone levels causes the incidence of sleep apnea among postmenopausal women to be between two and four times higher than that among premenopausal women.6 Because SAS in women only rarely produces snoring or sleepiness during the day, it is likely that women may not recognize the possibility that they have the syndrome. Increased efforts for SAS screening are needed because if left untreated, SAS can contribute to various forms of chronic diseases and increase patient’s health risk.

Recommendations • Raise the level of national health insurance reimbursement for SAS testing by physicians.

• Revise the criteria for prescribing CPAP treatment to match that of other developed nations where SAS testing is more common.

• Introduce SAS screening for adult males and postmenopausal women in annual health screenings.

References

1. Japanese Association of Pharmaceutical Medicine’s SAS Committee industry survey. www.japhmed.org.

2. American Sleep Apnea Association www.sleepapnea.org; American Academy of Sleep Medicine www.aasmnet.org.

3. Findley, L. 1988. American Review of Respiratory Diseases 138:337.

4. Young, T., Palta, M., Dempsey, J., Skatrud, J., Weber, S., Badr, S. 1993. The occurrence of sleepdisordered breathing among middle-aged adults. The New England Journal of Medicine (April) 328(17):1230–5 (Wisconsin Sleep Cohort Study).

5. Sleep-disordered breathing in the usual lifestyle setting as detected with home monitoring in a population of working men in Japan. Sleep 2008, 31:419–425.

6. Yukawa, K., Inoue, Y., Yagyu, H., et al. Gender differences in the clinical characteristics among Japanese patients with obstructive sleep apnea syndrome. Chest 2009, 135:337–343.

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May 2013

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13. Prevention and Management of Risk Factors for Diabetes

Situation Diabetes is a disease in which preventive medicine plays an important role. According to a 2007 survey, over 90 percent of the cases of the disease in Japan were type 2 diabetes, in which patients develop chronic hyperglycemia (high blood glucose) because of insufficient insulin secretion or a lack of insulin activity. As of 2007, 8.9 million people in Japan are strongly suspected of having diabetes, and another 13.2 million have the potential for developing diabetes. Thus, in addition to the patients already confirmed as having the disease, an estimated 22.1 million people in Japan may become diabetes patients.

Significant lifestyle changes in recent years are believed to be behind the dramatic increase in the number of people who suffer from diabetes.1 If a chronic hyperglycemic state persists, it can cause serious complications, such as coronary artery disease, diabetic retinopathy and nephropathy, resulting in a significant decline in quality of life. In serious cases, diabetes may result in loss of sight or the need for limbs to be amputated. Currently, it is estimated that about 40 percent of those who are strongly suspected of having diabetes have received almost no treatment.1 As many as 14,000 people in Japan die each year as a result of having diabetes.2 This situation caused diabetes-related medical spending in Japan to grow to approximately 짜1.15 trillion in 2007.3 In the United States, in 2006, diabetes accounted for $116 billion in direct medical costs and $58 billion in indirect economic costs, which included worker disability, work loss and premature mortality.4 Similar economic cost data is not available for Japan, but the economic burden is high and rising.

Diabetes can be prevented by improving lifestyle habits in areas such as nutrition and physical exercise. These improvements not only help prevent the development of diabetes but also help delay the onset of complications in patients who already have diabetes. Since there are few or no subjective initial symptoms, early detection of diabetes is difficult.

Consequently, regular health checkups, including blood sugar level tests and examination of the tiny blood vessels in the back of the eye, are important for the early detection of diabetes. Moreover, if the practice of home-based self-monitoring of blood sugar levels were to become more widespread, this could help prevent the onset of diabetes and assist people in maintaining even healthier lifestyles.5 Current Policy The government of Japan has launched policy goals designed to reduce the number of patients with diabetes by 25 percent, and increase the rate of special health screening (tokutei kenshin) to 80 percent by 2015. The special health screening rate in 2008 was 38.9 percent.6 As a method of early detection, a specific medical checkup and health education for metabolic syndrome were introduced in 2008. As a result, Japan is believed to be leading the global fight against diabetes. Until 2008, national health insurance reimbursement for medical treatment relating to the self-monitoring of blood sugar levels was limited to those patients with advanced diabetes requiring insulin injections. However, in April 2008, the national health insurance reimbursement plan was expanded at hospitals with less than 200 beds to provide 짜5,000 per year to cover the self-monitoring of blood sugar levels for diabetic patients not requiring insulin injections.

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Policy Change in the Past Year: Slight Improvement Diabetes related goals, including those in the updated Healthy Japan 21 program that began in April 2013, have been revised.

1. Reduction of complications. Goal: Reduce the number of patients requiring dialysis due to diabetic nephropathy from 16,247 (2010) to 15,000 (2022).

2. Increase the proportion of patients who continue treatment. Goal: Increase the ratio from 63.7 percent (2010) to 75 percent (2022).

3. Reduce proportion of patients unable to control blood sugar to within the JDS HbA1c value of 8.0 percent. Goal: Reduce the ratio from 1.2 percent (2010) to 1 percent (2022).

4. Curb the increase in the number of diabetes patients. Goal: Reduce the number of patients from 8.9 million (2007) to 10 million (2022)—rather than the projected 14.1 million.

Recommendations • To delay the progress of diabetes in patients who do not require insulin administration, expand health insurance reimbursements to cover self-monitoring of blood sugar levels at home.

• Since persons who are at risk of developing diabetes tend to have normal blood glucose levels when fasting, but higher postprandial (after eating) levels, they should measure not only fasting blood glucose levels, which is common practice in Japan, but also postprandial levels when conducting home-based blood sugar self-monitoring.

• Japan’s pharmaceutical regulations governing blood sugar level-related self-monitoring should be eased, while there should be an expansion of over-the-counter sales of selftesting products, which are approved in many countries.

• Comprehensive eye screening of persons aged 40 and over should be conducted to detect early warning signs of diabetes-related eye disease in the fine blood vessels and nerves at the back of the eye.8 • Bariatric surgery should be considered as an effective and safe treatment option for the non-severely obese (BMI <35 kg/m2) type 2 diabetes patients. Recent research shows that the metabolic benefits acquired from the procedures can be sustained long after surgery.9

May 2013

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References

1. Ministry of Health, Labour and Welfare. 2007. National Health and Nutrition Survey. www.mhlw.go.jp/houdou/2008/12/dl/h1225-5d.pdf.

2. Ministry of Health, Labour and Welfare. 2006 Vital Statistics of Japan. www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei06/hyo7.html.

3. Ministry of Health, Labour and Welfare. 2007. National Medical Care Expenditure. www.mhlw.go.jp/toukei/saikin/hw/k-iryohi/07/dl/data.pdf.

4. American Diabetes Association. 2007. National Diabetes Fact Sheet. www.diabetes.org/diabetes-statistics.jsp.

5. World Health Organization. 2009. Fact Sheet 312 (November). www.who.int/mediacentre/factsheets/fs312/en/.

6. Ministry of Health, Labour and Welfare. Healthy People 21 assessment team, 2nd meeting materials. www.mhlw.go.jp/stf/shingi/2r9852000001e9zs-att/2r9852000001ea3f.pdf.

7. Ministry of Health, Labour and Welfare, Health Science Council, Regional Health & Nutrition Promotion Committee, Special Expert Committee on the New National Health Promotion Plan. 2011.

Reference materials for the promotion of Healthy Japan 21 (stage two), (July). www.mhlw.go.jp/bunya/kenkou/dl/kenkounippon21_02.pdf www.kenkounippon21.gr.jp/ kenkounippon21/about/index.html.

8. International Diabetes Federation. Fact sheet. Diabetes and eye disease www.idf.org/fact-sheets/diabetes-eye-disease.

9. Blackwell Publishing Ltd. 2011. Diabetes, obesity and metabolism 14: 262â&#x20AC;&#x201C;270; 2012. Metabolic effects of bariatric surgery in type 2 diabetic patients with BMI <35kg/m2.

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13. Sharp Rise in People with, and at Risk of, Diabetes in Japan (10,000) 2500

2210

+61%

2000

1500

+29% 1000

1320

+94%

690 740

890

680

1620

1997

1370

2002

880

2007

500

0

(1)

(2)

(1) + (2) = (3)

lď Źâ&#x20AC;Ż 8.9 million persons highly likely to have diabetes lď Źâ&#x20AC;Ż 13.2 million may have diabetes lď Źâ&#x20AC;Ż 22.1 million persons at high risk of developing diabetes Source: MHLW, 2007, â&#x20AC;&#x153;National Health and Nutrition Survey.â&#x20AC;?

13. 40% of People Likely to Have Diabetes Receive Almost No Treatment Diabetes Treatment in Japan 100% 90% 80%

37.7 41.2

31.3 51.6

70%

5.4

60%

30.8 31.5

12.5

4.4

70

4 9.7

40%

56.9 54.1

20%

56.3

64.8 38.7

1.6

4

0 30

10%

40.6 43.5

8.2

4.7

50%

30%

52

60.3

44

55.4 54.8

xr{s!(z Untreated jnkrtl

Previously treated !(z jnkr (not gbyg$ j currently) qctc Undergoing $ !( treatment

0%

Male % Female=

Total= /

Male % Female=

Male%Female=

Male % Female=

50â&#x20AC;&#x201C;59= 60-69 60â&#x20AC;&#x201C;69 40â&#x20AC;&#x201C;49= 50-59 50-59 40-49

Male%Female=

70 Over 70

Source: MHLW, 2007, National Health and Nutrition Survey.

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Lengthening Healthy Lifespans to Boost Economic Growth | 63

13. New Diabetes Policy Goals in Japan’s Revised Healthy Japan 21 Diabetes-related goals in updated Healthy Japan 21 program began in April 2013.

1. Reduction of complications.

Goal: Reduce new annual dialysis patients due to diabetic nephropathy from 16,247 (2010) to 15,000 (2022).

2. Increase ratio of patients continuing treatment.

Goal: Raise from 63.7% (2010) to 75% (2022).

3. Reduce ratio of patients unable to control blood sugar to within JDS HbA1c value of 8.0%.

Goal: Reduce from 1.2% (2010) to 1% (2022).

4. Reduce increase in diabetes patients.

Goal: Limit number of patients (8.9 million in 2007) to 10 million in 2022, compared with the projected 14.1 million.

Source: MHLW, Reference Materials for the Promotion of Healthy Japan 21 (Stage Two), July 2011. http://www.mhlw.go.jp/bunya/kenkou/dl/ kenkounippon21_02.pdf.

13. Diabetes Policy Recommendations l Expand health insurance reimbursements to cover self-monitoring of blood sugar levels at home. l Home-based blood sugar self-monitoring should measure not only fasting blood glucose levels (common practice in Japan), but also postprandial (after eating) blood glucose level. l Ease pharmaceutical regulations to allow over-the-counter sale of blood sugar self-testing products, as in many countries. l Require comprehensive eye screening for people aged 40 or over to detect early warning signs of diabetic eye disease in fine blood vessels and nerves at the back of the eye. l Consider bariatric surgery as effective and safe for treating non-severely obese (BMI < 35 kg/m2) type 2 diabetes patients.

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14. Prevent Stroke and Provide Coordinated Care

Situation The most common causes of death in Japan are cancer, stroke, and heart disease.

Stroke alone accounts for 10 percent of total medical costs, and the number of patients is expected to grow from 1.5 million to 3 million by 2020. The average hospital stay for a stroke patient in Japan is 119 days. If there can be strong government leadership and adequate investments, Japan has the potential to establish a world-class program for stroke prevention.

Stroke patients must receive thrombolytic therapy (“clot busting”) with a tissue plasminogen activator (tPA) within three hours of having had a stroke for it to be effective, but the rate of usage in Japan is less than 2 percent. The shortage and uneven distribution of physicians, coupled with inadequate utilization of information technology (IT), often result in uncoordinated emergency care. If not afforded access to expert care, stroke victims can be left immobile, incontinent, and unable to speak. As a result, stroke patients account for 40 percent of bedridden care in Japan. Challenges also exist in sharing information between physicians and caregivers on rehabilitation needs, which can have a significant impact on a patient’s quality of life after suffering a stroke. Stroke care creates a significant economic burden and lost productivity for the supporting families and their communities as a whole.

According to a national public opinion survey conducted in 2011, 80.3 percent of Japanese would like more information about stroke and the prevention of stroke. The survey also showed that only 8 percent of Japanese are satisfied with the stroke emergency network in their region while 22.9 percent are dissatisfied and 44.1 percent say they do not have enough information about the stroke emergency network in their region.2 Current Policy The 2006 reimbursement revisions gave an additional 570 points (¥5,700) to medical institutions that implemented a Stroke Care Unit (SCU). SCUs must have round-the-clock emergency care capabilities in order to provide tPA intervention within three hours of the onset of stroke, as well as meet additional requirements for rehabilitation.

Despite efforts to encourage regional healthcare collaboration, much needs to be done to promote greater utilization of IT in order to support more effective prevention and earlier diagnosis of stroke, as well as better rehabilitation services. Investment in preventive strategies aimed at better cardiovascular health will provide a longer-term and more sustainable approach to improving outcomes in this patient group. Especially in the areas of Tohoku that have been affected by the 2011 earthquake and tsunami, many elderly people with deteriorating health conditions continue to live in difficult conditions. These people are at very high risk for stroke, which requires immediate attention when it occurs.

Recommendations • Develop a national health plan for stroke prevention and care.

• Establish a basic law for stroke prevention and care.

• Raise societal awareness of the need to adopt monitoring, early diagnosis, and intervention for stroke.

• Encourage patients at high risk for cardiovascular disease to seek medical care and intervention on a regular basis.

• Promote a regional stroke network.

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Lengthening Healthy Lifespans to Boost Economic Growth | 65

• •

Have better collaboration between hospitals and home care services for longterm care.

Publicize the location of SCUs to members of high-risk groups, primary care physicians, and both ambulance and taxi drivers.

Case Study: Ontario Stroke Network1 Ontario is the second-largest province of Canada. With a population of 13 million, Ontario accounts for one-third of Canada’s total population. The number of stroke patients is approximately 25,000 per year, of whom 15,300 remain hospitalized. In total, more than 90,000 patients suffer some kind of disability. Stroke care accounts for over 3 percent of the total healthcare cost in Canada. The Ontario Stroke Network (OSN) is an innovative, collaborative organization committed to enhancing stroke prevention and care for all Ontarians. The OSN is the credible advisor for the Ontario Stroke System and leads provincial initiatives and programs. The network is a responsive partner in integrated strategies aimed at improving patient outcomes, system efficiency, and access to care. It comprises nine Regional Stroke Centers that are connected to 16 District Stroke Centers, spread across other regional primary care centers. The annual age- and sex-adjusted in-hospital mortality rates due to stroke decreased 6 percent between April 2003 and August 2007.

Reference

1. Ontario Stroke Network. www.ontariostrokenetwork.ca/index.php.

2. ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

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14. Many Respondents—Especially Women—Want More Information about Stroke and its Prevention Q: How much information on stroke or on prevention of stroke do you have?

Overall (n=5000)

Males (n=2401)

Females (n=2599)

]=I have more than enough information ]=I have some information, but would like more ]=I do not have any information, but would like some ]=I do not have any information and do not need any Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

14. Older Japanese Want More Information about Stroke and its Prevention Q: How much information on stroke or on prevention of stroke do you have?

20–29 Yrs Old (n=678)

60–69 Yrs Old (n=882)

30–39 Yrs Old (n=863)

40–49 Yrs Old (n=800)

70–79 Yrs Old (n=790)

80+ Yrs Old (n=208)

50–59 Yrs Old (n=779)

]=I have more than

enough information ]=I have some information, but would like more ]=I have no information, but would like some ]=I have no information and do not need any

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

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14. 44% of Japanese Lack Information About Regional Stroke Emergency Networks Q: How satisfied are you with the stroke emergency network in your region?

Satisfied Dissatisfied

8.0%

22.9%

9.2%

22.5%

6.8%

23.1%

5.2%

14.9%

5.0%

17.1%

5.9%

19.8%

7.3%

25.5%

8.7%

26.8%

13.4% 29.9% 15.9% 30.3% ]=Satisfied ]=Neither ]=Slightly Dissatisfied

]=Slightly Satisfied ]=Do not have enough information ]=Dissatisfied Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

14. Ontario Stroke Network Helps Reduce Mortality Ontario Adjusted In-hospital Mortality Rate (%) 16

15.5

15

14.5

14

13.5

2003 to 04

2006 to 07

2008 to 09

Sources: Canadian Institute for Health Information, Discharge Abstract Database (CIHI-DAD); National Ambulatory Care Reporting System (CIHI-NACRS); 2003/94â&#x20AC;&#x201C;2008/09.

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15. Increase Early Detection of Peripheral Arterial Disease

Situation Peripheral arterial disease (PAD) is a type of atherosclerosis. The condition occurs when fat, cholesterol, and other substances build up on artery walls and form plaques. Over time, these plaques can block the arteries and cause problems throughout the body.1 Lower extremity PAD is characterized by a build-up of plaque in the arteries of the legs that obstructs blood flow, resulting in numbness of the legs, pain, or difficulty in walking. Worsening PAD can be associated with leg ulcers or necrosis. If untreated, amputation may be required. PAD complications often result in myocardial or cerebral infarction.

The Japan Atherosclerosis Society (JAS) guidelines, published in 2012, classify PAD, non-cardioembolic stroke, diabetes, and chronic kidney disease (CKD) as high-risk pathologies of arteriosclerotic diseases.2 Unfortunately, most patients are assumed to be asymptomatic or have atypical symptoms, and PAD goes undetected. Furthermore, there is no screening system to detect PAD in the general population. PAD patients’ poor life prognosis is unrelated to the presence or absence of symptoms.3 The prevalence of PAD in Japanese populations is between 1.7 percent and 4.3 percent.4 There are an estimated three million PAD patients in Japan, of whom three-quarters, or 2.3 million, have no symptoms. The five-year survival rate for patients with PAD is about 70 percent. The rate is similar to that for those with colorectal cancer, and worse than that observed in those with breast cancer.5, 6 When PAD is detected, healthcare providers are able to identify and optimally manage atherosclerotic risk factors, thus reducing the risk of grave outcomes. Drug therapy can reduce stroke and myocardial infarction (MI), and reduce mortality for PAD patients by up to 65 percent.7 However, many people are not aware of PAD risk factors, symptoms, and the fact that PAD itself is a major risk factor for cardiovascular events, such as stroke or MI, despite the fact it is often fatal.

Medical and nursing care costs are high—and expected to rise—for elderly people suffering cardiovascular diseases (CVDs). Medical expenditure for Japanese persons over the age of 65 are approximately ¥15 trillion.8 The number-one component of that expenditure is CVD (¥4.2 trillion), far ahead of the number two component, which is cancer (¥1.9 trillion). Stroke and MI alone amount to ¥1.9 trillion, comparable to expenditures for cancer.8 Moreover, stroke is the number-one reason for patients being care receivers or kaigo (21.5 percent), while approximately 1 million post-stroke patients are in need of longterm nursing care.9 The cost of this nursing care is estimated to be ¥1.9 trillion, which is greater than the annual cost of dialysis (¥1.4 trillion). In FY2012, long-term nursing care costs totaled ¥8.9 trillion. Thus, if the aging of the population advances at the current pace, by 2025, long-term nursing care costs are expected to be between ¥19 trillion and ¥24 trillion.10 Routine ankle brachial index (ABI) screening to detect PAD could have a substantial impact on medical expenditures in Japan, both in terms of morbidity and mortality, particularly in older individuals. In particular, screening high-risk populations (>65 years old; those over May 2013

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50 years of age with a history of smoking or with diabetes) could have a major impact on both incidence and prevalence of CVD. The ABI is a simple, accurate, and practical measurement used to screen for PAD. ABI is the ratio of the blood pressure in the lower leg to the blood pressure in the arm.11 Using ABI to screen for PAD, clinicians can detect up to three times as many PAD patients compared with screening that relies on symptoms alone. ABI clearly has been shown to be a predictor of cardiovascular morbidity and mortality.12 Moreover, ABI values correlate with impaired functional capacity, including slower walking, less walking, and lower knee extension force.11 Assessing the ABI takes five minutes or less of a healthcare provider’s time using inexpensive equipment. It is a painless procedure, in which the subjects lie down on a bed and have the blood pressure of the ankle and arm measured simultaneously. Healthcare providers can be trained in ABI measurement in 15 minutes or less. Thus, experts have recommended rapid and widespread implementation of ABI as a screening tool in the clinics of general practitioners in order to identify high-risk patients. Guidelines for the management of PAD, published by the American College of Cardiology/American Heart Association,13 state that resting ABI should be used to establish PAD diagnosis in patients with suspected lower extremity PAD, including those individuals who are aged 65 years or over, and those aged 50 years or over with a history of smoking or diabetes.

Since more than 40 percent of PAD patients have complications arising from cardiovascular events, such as MI and cerebral stroke14 and the risk of death is increased by such events,15 early detection of PAD is considered to have a great influence not only on PAD treatment but also on patient prognosis. It has also been reported that drug therapy decreases the death rate by 65 percent.7 Current Policy Under Japan’s ongoing health promotion program, the Standard Health Checkup and Counseling Guidance Program that began in April 2008 targets all people between the ages of 40 and 74 who are enrolled in public health insurance systems. However, ABI screening is not included in the checkup. In the Healthy Japan 21 campaign, specific goals have been set to improve lifestyles and, through early discovery, to prevent CVD. Reducing age-adjusted mortality due to CVD was recognized as an important issue in Healthy Japan 21, since the aftereffects of the disease are significant factors in lowering patients’ quality of life (QOL).16, 17 Policy Changes in the Past Year: No Change We believe that introducing ABI screening into the Standard Health Checkup and Counseling Guidance Program should be a priority, since the index allows the detection of PAD and the early identification of patients at high risk of cardiovascular events. Through the evaluation of high-risk individuals (e.g. people aged 65 or over; people aged 50 or over with diabetes or a history of smoking), it would be possible to prevent not only the aggravation of PAD, but also the onset of stroke and MI. By conducting the ABI screening of high-risk populations, as defined in the ACCF/AHA guidelines13 and TASC II guidelines,18 during regular community health examinations in Japan, it would be possible to detect a considerably higher number of potential PAD 70 | Lengthening Healthy Lifespans to Boost Economic Growth

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patients. This could reduce the incidence and prevalence of CVDs such as stroke and MI, as well as reduce medical and nursing care expenditure.

Recommendations Implement measures to increase screening levels among high-risk individuals in Japan in order to reduce the incidence and prevalence of CVDs. • Include ABI screening in the Standard Health Checkup and Counseling Guidance Program.

• Set nationwide and prefecture-wide numeric goals for ABI screening.

• Establish ABI as a screening tool in the clinics of general practitioners in order to identify high-risk patients.

References 1.

A.D.A.M. Medical Encyclopedia. U.S. National Library of Medicine. www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001224/.

2. Teramoto T, Sasaki J, Ueshima H, et al. 2007. Executive summary of Japan Atherosclerosis Society guidelines for diagnosis and prevention of atherosclerotic cardiovascular diseases. J Atheroscler Thromb. 14(2):45–50. (In Japanese.)

3. Diehm C, Allenberg JR, Pittrow D, et al. Mortality and vascular morbidity in older adults with asymptomatic versus symptomatic peripheral artery disease. Circulation. 2009;120:2053-2061.

4. Ohnishi H, Sawayama Y, Furusho N, et al. Risk factors for and the prevalence of peripheral arterial disease and its relationship to carotid atherosclerosis: the Kyushu and Okinawa Population Study (KOPS). J Atheroscler Thromb. 2010;17:751-8.

5. Kumakura H, Kanai H, Araki Y, et al: Survival rate and long-term results of treatment in patients with peripheral artery disease—Endovascular treatment, bypass surgery and medical treatment.

Angiology 46(5): 2006; 565-570.

6. National Cancer Center Research Institute. Study on enhancing and utilizing the regional cancer registration system. FY2004 report.

7. Pande RL, Perlstein TS, Beckman JA, et al: Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004.Circulation. 2011;124:17-23.

8. Ministry of Health, Labour and Welfare. Overview of the FY2009 national medical care expenditure.

9. Survey of long-term care benefit expenditure, Ministry of Health, Labour and Welfare, 2010.

10. Ministry of Health, Labour and Welfare. White paper, 2012.

11. Mohler E.R. 2003. Peripheral arterial disease: identification and implications. Arch Intern Med. 163:2306–14.

12. Diehm C, Lange S, Darius H, et al: Association of low ankle brachial index with high mortality in primary care. Eur Heart J 2006;27(14):11743-9.

13. Beckman JA, Findeiss LK, Golzarian J, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline). Vasc Med. 2011;16(6):452-76.

14. Yamazaki T, Goto S, Shigematsu H, et al. Prevalence, awareness and treatment of cardiovascular risk factors in patients at high risk of atherothrombosis in Japan. Circ. J. 2007; 71: 995-1003.

15. Kumakura H, Kanai H, Araki Y, et al. Evidence-based therapeutic strategy against arteriosclerosis obliterans – Distant-time results of and prognoses after various therapeutic regimens against arteriosclerosis obliterans: comparison of intravascular therapy, bypass surgery and drug therapy.

NovaAngiologicae 2006; 46: 565-70.

16. Health Service Bureau, Ministry of Health, Labour and Welfare. Kenkonippon21 Practical Guidebook,1999. www.kenkounippon21.gr.jp/kenkounippon21/jissen/index.html.

17. Ministry of Health, Labour and Welfare, Annual Report 2007–2008. http://www.mhlw.go.jp/english/wp/wp-hw2/part2/p2c1s3.pdf 18. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007. 45:S5–S67.

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15. Over 3 of 4 Persons with PAD in Japan Lack Symptoms, Go Undiagnosed Early detection, treatment of 2.3 million PAD patients with no symptoms could prevent 92,000 cardiovascular events and 33,000 cardiovascular deaths each year.

Source: Cardiovascular events and vascular deaths (one-year period) in a case of detection by ABI test followed by treatment and a case of no detection in asymptomatic patients with peripheral arterial disease (2.3 million patients) – Estimation from CAPRIE Study (CAPRIE Steering Committee: Lancet, 1996; 348: 1329–39) and Framingham Study.

15. Survival Rate for PAD and Colon Cancer Patients Is Similar: about Five Years

PAD2

PAD3

PAD4

Sources: 1. MHLW-funded cancer research, “Study on Improvement and Utilization of Regional Cancer Registration System”, report in fiscal 2004.

2. Tsushima N, et al. Progress in Circulatory Diseases, “Research,” 12 (1): 26–36, 1991.

3. Kobayashi M, et al. Jpn Circ J 64 (12): 925–927, 2000.

4. Kumakura H, et al. NovaAngiologicae 46

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15. Health Spending on Those Aged 65 and Over are Mostly for CVDs, including PAD

l Stroke and myocardial infarction alone amount to ¥1.9 trillion, comparable to cancer expenditures.1 (Prevalence of PAD in Japan is 1.7–4.3%.3) l Stroke is the number one reason to needing home nursing care (21.5%) and 1.0 million post-stroke patients are in need of long-term nursing care.2 l The estimated cost of this nursing care is estimated at ¥1.9 trillion, or even higher than the annual cost of dialysis (¥1.4 trillion).

Sources: 1. MHLW: Overview of 2009 National Medical Care Expenditure.

2. MHLW, Survey of Long-Term Care Benefit Expenditure.

3. Ohnishi et al, Journal of Atherosclerosis and Thrombosis. 2010;17:751-8.

15. ABI Screening Is Simple, Exact, Efficient Q: What is an ankle brachial index (ABI) test? l A simple, exact and efficient method for detecting PAD. l Effective in diagnosing asymptomatic patients. l May reduce cardiovascular events, such as MI and stroke. l Not accompanied by pain. l Requires only five minutes. l Calculates the ankle/brachial systolic blood pressure ratio. l A value lower than 0.9 may indicate PAD.

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16. Early Intervention in Musculo-Skeletal Disorders to Improve Health and Work Output

Situation While Japan faces the challenge of an older—and less healthy—working-age population, the growing number of unemployed, due to old age or disability, is placing additional physical and emotional strain on working individuals. It is estimated that, by 2035, slightly over 30 percent of the population will account for 70 percent of total medical expenses.

Thus Japan must prioritize prolonging individuals’ ability to continue working and contributing to society. Although much is being done in the areas of cardiovascular disease and cancer and in the area of mental health issues, a vast burden of chronic diseases with low mortality rates receives relatively little attention. In Japan, the long-term impact of musculoskeletal disorders (MSDs) is one of the areas that receive insufficient attention.

MSDs have a significant impact on people’s ability to work, on an individual and aggregate basis, affecting the productivity and labor-market participation of thousands of Japanese workers. Evidence suggests that: • In 2005, among a total of 87.9 million Japanese people aged 30 or over, lower back, hip, and knee pain was experienced by 21.4 million (24.3 percent), 3.2 million (3.7 percent), and 9.1 million (10.4 percent), respectively. By 2055, the rate of pain in these areas is expected to reach 26.5 percent, 4.4 percent, and 12.9 percent, respectively.1 • In terms of direct medical expenses alone, MSDs cost the Japanese economy and society up to ¥2 trillion a year (7.5 percent of national medical expenditure).2 • Each year, about ¥231.2 billion is lost due to work incapacity resulting from pain.3 The effects of incapacity and pain related to this and MSDs can impact several aspects of an individual’s work performance, including stamina, cognitive capacity or concentration, rationality/mood, mobility, and agility. It is becoming increasingly clear that people with MSDs are also likely to have depression or anxiety problems related to their conditions.

This, in turn, can affect the severity of the condition, the ability of the individual to remain in work, the length of time they spend away from work, and the ease with which they can be rehabilitated.

A delay in diagnosis or treatment of MSDs can make recovery, job retention and rehabilitation much more difficult. Only rarely do clinicians and occupational physicians work closely to ensure that clinical treatment is complemented by appropriate workplace interventions and vocational rehabilitation.

The growing incidence and effects of MSDs are expected to affect the quality of the working life of many Japanese, given the prospects of an aging workforce, as well as the increasing obesity, and decreasing exercise, physical activity, and fitness of the general population. This will adversely affect the productive capacity of the Japanese workforce just when it should be in top form.

Current Policy In the case of MSDs, patients have a range of treatment options. Of those seeking treatment for chronic pain (mostly caused by MSDs), 45 percent consulted an orthopaedic surgeon, 21.3 percent a general clinician, 15.1 percent a massage therapist or chiropractor, 12.4 percent an osteopath, and only 0.8 percent a specialized pain clinic. A 2010 survey of patients suffering chronic musculoskeletal pain shows that less than half (42 percent) of those with symptoms sought medical treatment. Of those, only 19 percent 74 | Lengthening Healthy Lifespans to Boost Economic Growth

May 2013

visited a hospital or clinic, while 20 percent sought complementary therapy (massage, folk remedies).4 The apparent reluctance to seek treatment suggests a lack of awareness of treatment options for MSDs in the early stages, or a failure to recognize the serious impact of MSDs on everyday life and workplace productivity.

The Ministry of Health, Labour and Welfare committee investigating chronic pain found that, although there is little communication among physicians on the subject, it has been recognized that there is a need to develop a multifaceted team approach to the treatment of MSDs. This should involve specialists, nurses, psychologists and others. A survey by the Rheumatoid Arthritis Friendship Association found that, in the interests of receiving improved medical care, patients most want links to be better between physicians and institutions.5 Recommendations • Facilitate early diagnosis and intervention, which are essential to curbing costs associated with temporary and permanent work incapacity. With occupational physicians ideally placed to identify the early presentation of many MSDs, effective routes should be found to make possible referrals and return to work.

• Collect reliable, standardized data on the prevalence of MSDs in Japan, and standardize data collection methods.

• Coordinate the actions of individuals, employers, occupational physicians, clinicians, and policymakers. Involve individuals in designing and maintaining good workplace practices.

References

1. Suka, M, Yoshida, K. 2009. The national burden of musculoskeletal pain in Japan: Projections to the year 2055. The Clinical Journal of Pain, 25(4):313–319.

2. Ministry of Health, Labour and Welfare. 2009. Estimates of national medical care expenditure.

3. American Chamber of Commerce in Japan. 2011. Survey on prevention, early detection and the economic burden of disease in Japan. www.accj.or.jp/doclib/advocacy/Healthcare_Survey_E.pdf 4. Nakamura, M, Nishiwaki, Y, Ushida, T, Toyama, Y. 2011. Prevalence and characteristics of chronic musculoskeletal pain in Japan. Journal of Orthopaedic Science 16:424–432.

5. Japan Rheumatoid Arthritis Friendship Association. 2010. Rheumatoid arthritis white paper: Actual conditions of rheumatoid arthritis patients. Tokyo: Shougaisha dantai teikikankoubutsu kyoukai.

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16. MSD in Japan: Impact of Rheumatoid Arthritis in the Workplace n Rheumatoid arthritis white paper: 41% of respondents report impact on work. n Most answers use ”suspension,” “shutting down,” or “retirement,” suggesting persons with RA want to work but have difficulties. Most common replies are: “Want to work but gave up due to RA”; “Unable to find employment.” n Those continuing to work have physical pain, lack understanding of colleagues.

Impact on Work (N=3,430, multiple answers)

Survey of rheumatoid arthritis patients; 41 =of 8,307 respondents said their work is impacted to a degree.

Suspension, shutting down, or retirement of business due to rheumatoid arthritis Continued (continues) to work but suffers from physical pain and lack of understanding by colleagues

GHAF> EFAI>

Wanted to work but gave up due to rheumatoid arthritis

DEAK>

Employer understood situation and gave me different job to do that is easier Symptoms were mitigated and found work again

JAI>

EAI> EAC> DAJ>

No answer Other CAC>

FAE>

Symptoms have been mitigated but have been unable to find employment Was able to continue working through designation as a worker with a physical disorder

Source: Japanese Rheumatoid Arthritis Society, Rheumatoid Arthritis White Paper, 2010.

HAJ>

DCAC>

ECAC>

FCAC>

GCAC>

HCAC>

16. Choice of Treatment by Persons Suffering Chronic Pain, Including MSD (in Japan) Treatment Choice for Chronic Pain (N=1,770) Ratio of patients with chronic pain (15.4%) among those aged over 18 (N=118,507)

No Answer 3%

HP/ GP 19% None 55%

Folk Remedy 20%

Hospital or General Practitioner Folk Remedy

n Over half those with chronic pain (including MSD) don’t get treatment n Ratio of HP/GP vs. folk remedies is similar among those being treated

Both Above None

Both Above 3% Source: Toyama, Y., et al. Prevalence and characteristics of chronic musculoskeletal pain in Japan. MHLW Research, 2010.

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16. How Does Japan’s Situation Make It Difficult for MSD Patients to Work? l Lifelong employment model complicates reentry into labor market. l Principal role of occupational physicians in managing employee health. l Occupational health still focused on ergonomics, less on psychosocial aspects of work environment. l Considerable disconnect between occupational health and clinical systems. l Culture of non-disclosure greater than in Western Europe; tendency to self-medicate (alternative medicines). l Recognition of the societal cost of pain—opportunity to update practices for managing chronic pain.

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17. Increase Wellness Through Treatment of Chronic Pain

Situation Pain can be divided into two types, acute pain and chronic pain. The International Association for the Study of Pain (IASP) defines chronic pain as “pain that extends beyond the expected period of healing.” Most frequently responsible for chronic pain are lower back pain, osteoarthritis, rheumatoid arthritis, spinal compression fractures, and cancer.

Over the past few decades, there have been significant advances in research and medical knowledge around the world about the causes of, and effective treatment for, chronic pain.

Nevertheless, patients in many countries, including Japan, remain dissatisfied with the current treatment of chronic pain.

According to scientific studies conducted in many countries, including investigations by members of IASP and the U.S. National Academy of Sciences, the impact of inadequately treated chronic pain is remarkably similar worldwide.

• Roughly one-third of those with severe chronic pain (6.7 percent of the world population) have a suboptimal ability to perform wage-earning work, including persons who can no longer work.1 • Persons with chronic pain that is not treated occasionally have difficulty caring for their children, sleeping adequately, and working normally. Untreated chronic pain can even give rise to such problems as depression, social seclusion and the contemplation of suicide.2 • In extreme cases, chronic pain causes individuals to become bedridden and places an increased burden on their families and on society in general. When the cause of chronic pain is difficult to ascertain, it can cause significant frustration for healthcare professionals who provide the patient with care and support. Inadequately treated pain can lead to adverse physiological, psychological, economic, and social effects on patients, their family members, and society.

• Fewer than 50 percent of patients with cancer-related pain receive effective relief.

Fewer than 50 percent of patients with acute pain receive effective relief. Fewer than 10 percent of patients with chronic non-cancer-related pain have access to effective pain management.2 • In terms of economic impact, large-scale surveys in many countries have shown that chronic non-cancer-related pain ranks as the third-most costly healthcare problem after cancer and cardiovascular disease.3 In the United States, the economic costs of pain amount to between $560 billion and $635 billion (¥4.5–¥5.1 trillion), which is higher than the costs of cardiac disease, cancer, or diabetes mellitus.4 International recognition of the extent of the social and economic burden of chronic pain has produced a growing trend toward increased emphasis on the development of national pain strategies to expand access to pain relief and treatment. The IASP held the first International Pain Summit on pain control policy during its 2010 global conference, at which a model national pain control strategy was proposed, and an evaluation of the national pain policies of 18 countries was announced. At the end of the summit, the Montreal Declaration was issued, which states that it is a basic human right to receive pain management.

In 2010, the U.S. Congress and President Barack Obama worked together to pass a law designed to promote the protection of patients’ rights and research/treatment on pain control across the country. In 2011, under the direction of the U.S. Congress, the National Academy of Sciences published a white paper entitled Relieving Pain in America—A 78 | Lengthening Healthy Lifespans to Boost Economic Growth

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Blueprint for Transforming Prevention, Care, Education and Research.4 In 2011, the World Health Organization issued its Guidelines on Availability of and Access to Controlled Substances, proposing more balance in national strategies regarding access to controlled substances for medical use, including drugs for pain control.5 The research conducted by the IASP on pain control strategies adopted by individual countries evaluates each country’s strategy based on the following four factors: (1) research on pain (epidemiology and basic research); (2) education about pain (courses at universities/medical schools, post-graduate training for general practitioners, postgraduate training for specialists, continuing training for physicians and other healthcare professionals, and education of the population in general); (3) access by patients and coordination of treatment (treatment, drugs, information, referral to specialists, multifaceted approach beyond the borders of specialties, self-control of pain); and (4) monitoring and quality improvement (time until treatment, quality of services, quality of life, economic burden, special needs [people with disabilities]). Although many countries have been increasing their efforts relative to pain control policies, there is still room for improvement.1 Chronic pain causes a social burden in Japan comparable to that found in other countries. However, despite the fact that low-cost solutions may be available, there is a tendency in society to view chronic pain as something to be endured, as well as a lack of understanding of the magnitude of the problems arising from unresolved chronic pain.

These factors cause the level of awareness and amount of attention given to chronic pain to remain low.

According to a national public opinion survey, 11.3 percent of all Japanese adults aged 20 or over experienced level 5 or greater chronic pain that continues or reoccurs for at least three months.6 The estimated annual economic burden of pain in Japan is ¥370 billion per year, with an estimated 7.1 million adults having their ability to work undermined by pain.6 Some 42.5 percent of working adults who had chronic pain say that their pain diminished their ability to work, including 25.2 percent who said they could not achieve their full potential (productivity declined) and 13.7 percent who said they had to reduce their working hours. In terms of social burden, 46.7 percent of those with chronic pain said that they had “felt depressed” during the previous month, 40.3 percent said that they could not walk or climb stairs, and 28.4 percent said they could not perform household chores such as cooking or cleaning.6 The increased adoption of multidisciplinary approaches to treatment and the approval of new medicines have expanded the options for pain control in Japan, making it possible for patients to reduce their pain and return to their daily lives. Globally, the recent introduction of new treatment guidelines and new treatment methods has contributed to more effective treatment of chronic pain than in the past. In terms of government policies, the Ministry of Health, Labour and Welfare (MHLW) began new initiatives in 2009, including the launch of a government panel on chronic pain. These efforts are expected to contribute to freeing patients from the constraints of their chronic pain.

Current Policy At present, measures for the control of cancer-related pain are conducted within the framework of palliative care under the Basic Law on Anti-Cancer Measures. In December May 2013

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2009, the MHLW organized the Panel on Chronic Pain which, in September 2010, proposed that the following be implemented: (1) medical system-related measures; (2) education and public awareness; (3) information and consultation; and (4) pain surveys and research. The MHLW included funding for chronic pain research in the 2011 budget to support the implementation of the panel’s proposals.

Policy Changes in the Past Year: No Change In 2012, the MHLW provided ¥120 million in funding for seven research projects in the areas of diagnosis and treatment of chronic pain.7 Recommendations • Implement the 2010 proposals of the MHLW Panel on Chronic Pain as soon as possible.

• Conduct research on, and assess the social and economic impact of, pain in Japan.

• Raise social awareness about chronic pain.

• Based on the latest methods of diagnosis and treatment, promote education for physicians and nurses (undergraduate, postgraduate, and specialist education), as well as for patients (in the areas of pain treatment and self-control of pain). In particular, require education on the proper medical use of controlled substances that are used to manage chronic pain.

• Consider ways to optimize the healthcare system for pain control, including by revising the national health insurance reimbursement system (additional reimbursements for chronic pain control and modification of the current reimbursement schedule). One option is to divide chronic pain control into three categories: primary care (general practitioners and general hospitals); secondary care (multidisciplinary pain care teams, including nurses at core hospitals); and tertiary care (specialized pain centers).

References

1. IASP International Pain Summit. 2010. Montreal, Canada (September 3).

2. In September 2010, the MHLW reported the combined impact of suicide and depression on the Japanese economy. Due to death-caused loss of income and the need for pension payments to be made to emotionally unstable individuals, the impact had amounted to ¥2.7 trillion in 2009.

3. Abu-Saad Huijer, H. Chronic pain: a review. 2010. J Med Liban 58:21–27; and Tsang, A, Von Korff, M, Lee, S, et al. 2008. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain. 9:883–891.

Both texts cited in IASP International Pain Summit, Montreal, Canada. Desirable characteristics of national pain strategies: Recommendations by the International Association for the Study of Pain (September 3, 2010).

4. Institute of Medicine of the National Academy of Sciences. 2011. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research.

5. World Health Organization. 2011. Guidelines on Availability of and Access to Controlled Substances.

World Health Organization Press, Geneva, Switzerland. www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html.

6. American Chamber of Commerce in Japan. 2011. National internet survey on prevention, early detection and the economic burden of disease in Japan. (October 31–November 2). Covered 5,000 adult respondents, from Rakuten Research’s registry, representative of the Japanese population in regard to regional, age, and male-female distribution.

7. Japanese Ministry of Health, Labour and Welfare. Overview of national government funding for chronic pain research. www.mhlw.go.jp/seisakunitsuite/bunya/hokabunya/kenkyujigyou/hojokin-koubo-h24/gaiyo/15.html.

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17. 11.3% of Adult Japanese Have Chronic Pain (Level 5 or More, 3 Months or More) Q: How long has your worst pain (including strong tingling sensation) persisted or recurred? (Asked of those with pain of level 5 or more. Single answer.)

] Pain of Level 4 or Lower, or No Pain. (n=3,990 out of 5,000 respondents) May 2013

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

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17. 46.7% with Chronic Pain Are Depressed; 40.3% Find Climbing Stairs, Walking Hard Q: How has the pain affected your personal daily life? Asked of 563 persons with pain of level 5 or more for 3 months or longer. (Multiple answers)

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

17. 42.5% of Chronic Pain-afflicted Workers Claim Ability to Work Reduced Question: How has pain (including strong tingling) affected your work? Asked of 383 persons working with pain of level 5 or more for 3 months or longer. (Multiple choice.)

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

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17. Mental Illness and Pain Place the Greatest Economic Burdens in Japan Type of Loss

Absenteeism (¥)

Presenteeism (¥)

Partial Disability (¥)

Full Disability (¥)

Total Economic Loss (¥)

Physical injury or disability

29 billion

32 billion

66 billion

28 billion

155 billion

Infectious diseases or viral infections

26 billion

29 billion

47 billion

56 billion

159 billion

Pain

88 billion

53 billion

197 billion

35 billion

372 billion

Non-infectious chronic disease

17 billion

67 billion

74 billion

136 billion

294 billion

Mental illnesses

202 billion

101 billion

510 billion

211 billion

1.023 trillion

Total due to own health problem

361 billion

282 billion

894 billion

466 billion

2.003 trillion

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

17. Health Issues Afflict 16mn Persons in Japan; Pain Most Affects Ability to Work Estimated Absentees (Persons)

Estimated Presenteeism (Persons)

Estimated Partial Disability (Persons)

Estimated Full Disability (Persons)

Total with Economic Loss (Persons)

Physical injury, disability

2,160,026

935,179

830,618

1,082,845

4,866,246

Infectious disease, viral infection

1,171,675

911,897

353,013

458,833

2,789,702

Pain

4,407,729

1,474,557

726,791

895,641

7,131,568

Non-infectious chronic disease

1,219,498

1,078,755

415,309

1,104,869

3,691,635

Mental illness

2,518,702

1,245,612

851,383

1,607,749

5,495,502

Total

7,970,576

3,880,412

1,887,768

3,670,660

16,192,854

Health Problem

Source: ACCJ National Survey on Prevention, Early Detection & the Burden of Disease in Japan, Nov. 2011.

Note: Figures are calculated based on population data released by the Ministry of Internal Affairs and Communications (November 2011: 104,876,000; 20 years old or over). Excludes costs associated with caring for family members with health problems.

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18. Prevention and Early Detection of Mental Illness

Current Status In recent years, the number of patients receiving treatment for mental illnesses, such as depression, schizophrenia, dementia, and anxiety disorder, has been increasing in Japan and is expected to continue doing so.1 While 2.18 million patients with mental illnesses were consulting medical institutions in 1996, the number reached 3.23 million in 2008, a drastic increase of approximately 1.5 fold. Schizophrenia, dementia in elderly people, depression among the working-age population, and developmental disorders are becoming diseases that are familiar in the daily lives of the general population. These diseases require solutions and measures not only for the patients themselves, but also for their family members and people in the surrounding environment. Data shows the number of patients with “mental and behavioral disorders” now significantly surpasses the numbers for other common health problems, such as diabetes mellitus, malignant neoplasm (cancer tumors), cerebral vascular disease (which can lead to strokes) and ischemic heart disease (which can lead to heart attacks). Furthermore, mental illnesses such as depression are widely seen as one of the causes of suicide, the number of which exceeded 30,000 per year in Japan for 12 consecutive years from 1998.

On July 6, 2011, the Ministry of Health, Labour and Welfare announced that mental illness would be designated the fifth major disease for which Japan’s prefectural governments are required to implement measures associated with both the regional medical treatment cooperation system and other measures to be specified, based on the Medical Service Law. Previously, the scheme only covered four major diseases, namely, cancer, cerebral stroke, acute myocardial infarction, and diabetes mellitus. The inclusion of mental illness as one of the five major diseases will greatly increase the priority it receives in health policy.

Now, each prefectural government is required to specify measures for mental illness in its medical scheme, which will have a significant impact on society. In addition, the new designation of mental illness as one of the major diseases covered under the Medical Service Law means that it should be emphasized more in discussion on how to amend the Industrial Safety and Health Law, how to enhance medical services and related insurance and welfare services, and how to improve healthcare quality in general.

On September 28, 2011, the Board of Directors of the Japanese Society of Psychiatry and Neurology presented the following recommendations on important issues concerning the environment surrounding mental illness:2 • Set up functions whereby initiatives and decisions concerning medical services for mental illness are discussed among psychiatrists and related healthcare professionals, parties involved in related health and welfare services, residents, patients, and other parties concerned.

• In order to prepare a new scheme for mental illness care, it is vital to grasp the current situation and provide an appropriate analysis. For this, the parties concerned should investigate, understand, and analyze the current state of psychiatric care in each region in conjunction with government bodies, and disclose information about the conclusions of their analysis as appropriate.

• Set up numerical policy targets for verifying the level of achievement of various medical functions specified in the plan (the data for the numerical targets must be verifiable in terms of the progress and the level of achievement through continuous data capturing and analysis).

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In addition, a proposed draft amendment of the Industrial Safety and Health Law would mandate private companies to provide a doctor or public health nurse to perform testing to assess the mental health of employees in annual health checkups and take the initiatives to enhance various measures concerning mental health.3 According to the proposed draft amendment: • The mental health test results would be directly reported to each employee by the testing doctor or public health nurse, and in no event would they be disclosed to the employer without the employee’s consent.

• If an employee who has received the mental health test results then requests consultation with a doctor, the employer must facilitate such a consultation, provided that in no event would employees be treated unfairly by the employer for requesting a consultation.

• Should the employer receive the doctor’s recommendation after the consultation, it will reassign responsibilities, shorten work hours, and/or take other necessary measures as appropriate.

According to an ACCJ national survey on the economic burden of disease, each year Japan experiences economic losses worth at least ¥3.3 trillion, due to health problems that cause absenteeism, disability, and lower productivity while at work.4 Of this amount, ¥2 trillion was due to people’s own health problems and ¥1.3 trillion to the health problems of family members. Of five major types of health problems (physical injury or disability, infectious disease, non-infectious chronic disease, pain, and mental illness), mental illness had the largest annual economic burden, totaling approximately ¥1 trillion. Furthermore, based on the responses of those surveyed, the following is evident concerning mental care: • Some 16.3 percent of Japanese have consulted a doctor or healthcare professional about their mental health.

• Of those who have consulted a doctor or healthcare professional, 55 percent cited depression, 45.9 percent cited anxiety, and 43 percent cited stress as symptoms.

• Of the economic burden of mental health, 50 percent was due to partial disability, 20.6 percent to full disability, 19.7 percent to absenteeism, and 9.9 percent to lower productivity while at work.

According to the World Health Organization, 24 million mental illness patients worldwide suffer from schizophrenia, which is considered to be treatable with medication, psychotherapy, rehabilitation, and other therapies.5 Although treatment is more effective the sooner it is provided, more than half the patients worldwide are not receiving appropriate treatment at all. For patients to successfully return to a normal daily lifestyle, it is often necessary to have a community-based approach and the active cooperation of family and acquaintances.

In order to help reduce the stigma, discrimination, and misunderstanding that schizophrenia patients and their families experienced in the past, in 2002 the Japanese term seishin bunretsubyou (split mind) was changed to togo shitchosho (integration disorder), a term that more accurately describes the symptoms of patients with schizophrenia. In 2012, a nationwide public awareness survey on schizophrenia conducted among 500 men and women between 20 and 69 years of age shows that the recognition of the former term seishin bunretubyou was higher (64.6 percent) than that of the new term togo shitchosho (55.6 percent).6 On the other hand, the survey showed that patients diagnosed with schizophrenia tended to “actively receive treatment” while in the past they May 2013

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tended to “hide” their disease. The change, in part, may be attributable to the change in terminology.6 Key results of the public awareness survey on schizophrenia are: • Recognition of terms: 55.6 percent of respondents recognized the new term, togo shitchosho, while 64.6 percent recognized the former term, seishin bunretsubyou.

The higher the age of the respondent, the higher the recognition of the new term, with 88 percent recognition among subjects aged 60–69.

• Perception of the term: 93 percent responded that they would feel comfortable using the new term, even if they or somebody they know developed the condition.

• Perception of treatment: 45.4 percent responded that they “would want to receive treatment right away if they were diagnosed” with schizophrenia and 83.6 percent responded that they “would recommend treatment if a family member were diagnosed” with schizophrenia. Only a small minority of respondents said they would be ashamed, would be unable to accept, or would conceal the condition.

• Perception of cause: 57.6 percent thought that the disease was attributed to “problems in interpersonal relationships,” (the most common response). Less than half of the respondents (43.6 percent) understood that schizophrenia is “a disorder of the brain and nervous system.”

• Perception of patients: When asked how they would respond “if an acquaintance or neighbor has schizophrenia,” 76 percent answered that they would “treat them just like any other person” or “help them.”

Schizophrenia commonly occurs in patients of a young age when they are establishing themselves independent of their parents. The mean age of onset is 18 in men and 25 in women. Unfamiliarity with the symptoms often makes early diagnosis difficult, and in many cases it takes many years between the time that the symptoms first appear and when the actual treatment is given. Furthermore, when medication is not used appropriately, symptoms recur within one year of diagnosis for 70–80 percent of patients.

The long-term prognosis varies from patient to patient, but generally one-third of patients experience a remarkable and persistent improvement, one-third experience some improvement but with periodic recurrence and residual disability, and one-third have severe and permanent disability. Even if the symptoms improve, patients may not be able to fully return to school or work, causing various social issues including discrimination, poverty, and homelessness. About 10 percent commit suicide. Considering the impact on patients’ lives and the economic burden, it is vital to provide comprehensive and long-term community-based support, including in the areas of medical care, welfare, daily life support, and employment support. In particular, community-based support for employment is of the greatest importance for rehabilitation into society, because it facilitates both the mental and financial stability of patients.7, 8, 9, 10 Recommendations • Improve the medical system and healthcare environment for mental illnesses in ways that promote early diagnosis and early treatment, with the goal of improving patients’ quality of life and reducing the economic burden.

• Provide rehabilitation intended to facilitate patients’ early return to society, including support for home medical care and employment opportunities.

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â&#x20AC;˘

Revise the Industrial Safety and Health Law to require employers to provide their employees with the opportunity for a mental health checkup by a medical doctor or public health nurse as part of their annual health checkup.

Case Study: Reform of the Mental Health Care System and Early Intervention for Mental Illness in the UK In the 2000 version of the National Health Service Plan that the U.K. Department of Health releases every three years, the priority of mental illnesses was raised to the highest level, namely, the same as that of coronary heart disease and cancer.11, 12 Specifically, 50 early intervention teams (1 team per 1 million people) were set up within three years in order to facilitate active community support for the treatment and care of young people with mental illnesses and their families. This enabled all young patients experiencing initial episodes of mental illness, including schizophrenia, to receive intensive and early treatment. Every year, 7,500 young patients are enrolled in this project and given continuous support for three years, in order to shorten the duration of untreated psychosis to an average of three months. The budget for this program has been increased every year so as to fully support mental health treatment services (the budget exceeded ÂŁ2 billion in the first 10 years).

Case Study: Bethel House in the Town of Urakawa, Hokkaido Founded in 1984 in Urakawa-cho, Hokkaido, Bethel House is a community-based facility with various activities for patients with mental illnesses, including schizophrenia.13 It includes the Urakawa Bethel House Social Welfare Corporation, the Bethel Welfare Shop Ltd., and a partnership with the Urakawa Red Cross Hospital to provide three pillars of community support that integrate medical treatment, daily life support, employment support, a common living space that includes rehabilitation, a common place of employment, and a common locus of community care. Currently, more than 100 patients reside and spend their days in the area. In addition, as part of ongoing patient-initiated research, current and past patients, together with volunteers, meet to discuss, share, and research ways of coping with and overcoming the various challenges of living with mental illness. Recently, Bethel House has been getting the attention of specialists as a successful example of patients supporting patients, patients being entrepreneurs, and the supportive engagement of businesses and employers in the community. The activities now are attracting the attention of experts in Japan and overseas, and the facility has about 2,000 visitors every year.

References

1. www.mhlw.go.jp/kokoro/.

2. Japanese Society of Psychiatry and Neurology. www.jspn.or.jp/ktj/index.html.

3. Mental Health Welfare Task Force. 2004. Vision for the reform of mental health treatment and welfare (September).

4. American Chamber of Commerce in Japan. 2011. Press release (November 25).

5. www.who.int/mental_health/management/schizophrenia/en/.

6. Janssen Pharmaceutical K.K. 2011. Press release (June 15).

7. Merck Manual. Ver. 18 (in Japanese).

8. Japanese Journal of Clinical Psychopharmacology. 2009;12(3).

9. Japanese Journal of Clinical Psychopharmacology. 2010;13(7).

10. SEISHIN ZASSHI 2009;111:3.

11. Journal of Japanese Association of Psychiatric Hospitals, March 2010;31(3):171.

12. U.K. Department of Health. www.dh.gov.uk/.

13. http://urakawa-bethel.or.jp/.

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18. Mental Illness Patients Have Rapidly Increased to 3.23 Million People. Depression Can be a Factor in Suicide.

350 Â

2.18

2.04

Million

Million

2.58

Million

300 Â

27.3 6.0 12.4

250 Â

200 Â

150 Â

100 Â

3.03

Million

25.8 5.6 10.3 31.7 6.1

7.5

23.5 5.0 8.4

46.6 Â Â

42.4 Â Â

43.3 Â Â

44.1 Â Â

50 Â

72.1 Â Â

66.6 Â Â

0 Â

2.0 Â Â 9.1 Â Â

2.9 Â Â 12.1 Â Â

3.23

Million 21.9 6.6 16.4

Types of Mental Illness of Patients Going to Medical Institutions

58.9 Â Â

q{f{ Â

Epilepsy Drug/Alcohol Abuse mv  Other Mental Illness : ts  Anxiety Disorder dp&ts  Depression . 5'ts  Schizophrenia Dementia (Alzheimer) 4*'Â?|Â&#x160;Â&#x201E;Â&#x2020;}Â&#x2021;Â?&Â&#x2018;  Dementia (VD) 4*'Â?1- tsÂ&#x2018; Â

58.5 Â Â

0#Â&#x152;|Â&#x160;Â Â?Â&#x160; 'ts Â

50.0 Â Â 92.4 Â Â

104.1 Â Â

71.1 Â Â

73.4 Â Â 8.9 Â Â 13.8 Â Â

75.7 Â Â 17.6 Â Â 14.5 Â Â

8 Â Â Â Â Â Â 11 Â 1996 Â 1999 Â Â Â Â Â Â Â Â Â 14 Â 2002 Â Â Â Â Â Â Â Â Â Â 17 Â Â Â 2005

79.5 Â Â

24.0 Â Â 14.3 Â Â 20 Â Â Â Â 2008 Source: http://www.mhlw.go.jp/kokoro/speciality/data.html

18. 16.3% of Japanese Have Consulted a Doctor or Counseling about Mental Health; Depression Most Common Reason Q: Have you consulted a doctor or a healthcare professional about your mental health? (Single answer) Overall (n=5000)

14.5 % Â

Q: What types of symptoms did you suffer when you thought you had mental health problems and consulted a healthcare professional? (Multiple answers)

55%  Depression  Feeling  of  anxiety/Feel  more  anxious  compared  to  before Â

1.8% Â

83.7 % Â ]=Yes, went to clinic/hospital (723 respondents) ]=wc` Â&#x2030;Â&#x2026;Â&#x192; /&9u2onÂ?723 Â&#x2018; ]=Yes, did not go to clinic/hospital but ]=wc`Â&#x2C6;Â&#x2039;Â&#x201A;Â&#x160;Â&#x20AC;|v, telephoned a mental care consultation center __)6tsu;3zlnÂ?90 Â&#x2018; (90 respondents) ]=cceÂ?4,187 Â&#x2018; (4,184 respondents) ]=No

45.9% Â

Stressed/Feel  more  stressed  compared  to  before Â

43.5% Â

Lack  of  moQvaQon/Lack  moQvaQon  compared  to Â

32% Â

PalpitaQon Â

24.1% Â

Suddenly  feel  sad  and  burst  into  tears/feel  sadder Â

22.8% Â

Dizziness Â

22.3% Â

Easily  angered/Get  irritated  more  oMen  compared  to Â

(n=813)

20.4% Â

Other Â

12.2% Â 0 Â

10 Â 20 Â 30 Â 40 Â 50 Â 60 Â

Source: National Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan by ACCJ , November 2011

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18. Economic Burden of Disease in Japan Is About ¥2 Trillion Annually; Over Half Due to Mental Illness Two major causes of the economic losses are mental illness and chronic pain, (excluding economic loss affecting family members). Prevention and early detection of mental illness is urgently needed to reduce the burden.

Causes of ¥2 Trillion in Annual Economic Losses Due to Health Problems Infectious Physical Diseases or Injury or Disability Viral 155 Infections 159

NonInfectious Chronic Disease 294

Pain 372

Breakdown of ¥1.023 Billion in Annual Economic Losses Due to Mental Illness

9.9%

Presenteeism

Mental Illness 1,023

19.7%

Absenteesm

20.6%

50%

Partial Disability

Full Disability

Source: National Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan by ACCJ , November 2011

18. Policy Recommendations l Improve the medical system and healthcare environment for mental illnesses in ways that promote early diagnosis and early treatment, with the goal of improving patient’s quality of life and reducing the economic burden. l Provide rehabilitation intended to facilitate patients' early return to society, including support for home medical care and employment opportunities. l Revise the Industrial Safety and Health Law to require employers to provide their employees with the opportunity for a mental health checkup by a medical doctor or public health nurse as part of their annual health checkup.

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19. Promote Treatment of iNPH to Reduce Gait Impairment and Dementia in the Elderly

Situation A dramatic increase in life expectancy coupled with a falling birth rate has caused an increase in the proportion of the elderly in the population of Japan. In 2005, the percentage of people aged 65 years or over in Japan became higher than that in other major industrialized countries, and reached 23 percent in 2010.1 This places Japan in the category of a super-aging society, as defined by the World Health Organization. Along with the growing elderly population, Japan is facing various problems that are difficult to solve, such as the increasing costs of long-term care and medical expenses.

Amid these challenges, patients with one particular disease are expected to benefit from recent medical advances. The disease is idiopathic normal pressure hydrocephalus (iNPH), which is characterized by dementia and gait impairment. iNPH is a major cause of falls in the elderly. The importance of the diagnosis and treatment of the disease has been advocated mainly by societies of specialists (neurosurgeons and neurologists) against the background of the super-aging society. iNPH is not yet fully understood by healthcare professionals other than specialists. It is often overlooked or confused with other diseases, because its major symptoms—dementia, gait impairment, and urinary incontinence— overlap with symptoms commonly found in the elderly. The Guidelines for Management of iNPH, issued in 2004, brought about the current diagnostic consensus among specialists. A basic cerebrospinal fluid (CSF) shunting technique, feasible in any standard neurosurgical facility, is now employed for treatment of iNPH. Recent investigations by the study groups of the Rare/Intractable Disease Project, supported by the Ministry of Health, Labour and Welfare (MHLW), have revealed the prevalence of this disease and the degree of improvement in patients after diagnosis and treatment, clearly indicating the benefits of accurately diagnosing and treating iNPH. In patients for whom a proper diagnosis of iNPH is made, 80 percent show improvement after treatment, while 13 percent of all patients diagnosed with iNPH go on to lead independent lives.2 A recent meta-analysis of iNPH studies has suggested that 1.1 percent of elderly persons may have iNPH.3 Considering the large elderly population, the number of patients with iNPH in Japan may exceed 310,000. This number is double the number of patients with Parkinson’s disease, and one-fourth the number of those with Alzheimer’s disease. It has also been stated that patients with iNPH account for 10 percent of all patients with dementia,4 indicating that detection of iNPH at an early stage of the disease and treatment (via CSF shunting) can prevent this proportion of patients from developing a need for the most intensive category of home nursing care. A clinical study of 100 patients showed that improvement of the symptoms of iNPH enabled a 47.3 percent reduction in home nursing care insurance expenditures.2 This reduction yielded a reduction of ¥53 million in total healthcare costs (including home nursing care and medical treatment costs) over two years.5 Moreover it is estimated that, over five years, there could be a reduction of approximately ¥30 billion—including nursing care insurance and medical treatment costs— were this treatment provided to all of the estimated 310,000 patients.

It goes without saying that treatment of iNPH brings improvement in the quality of life of both patients and caregivers. In particular, the greatest improvement can be achieved in the area of gait impairment, a risk factor for falling and fractures in the elderly.

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the survival rate, physicians tend to focus on the treatment of fractures and osteoporosis, paying less attention to the underlying disease that serves as a risk factor for falling.6 Most cases of falling in hospitals or accidents in nursing care facilities that result in a broken or fractured bone involve falls by elderly persons.7, 8 Treatment of fractures leads to great economic cost. Medically related civil suits are common, with more than 1,000 such suits filed every year in Japan.9 In summary, it is presumed that treatment of iNPH can cause improvement in dementia, gait impairment, and urinary incontinence, leading to the prevention of falls/fractures and bedridden status and, ultimately, enabling containment and optimization of care insurance costs and medical expenses.

Even though the diagnosis and treatment of iNPH are considered to be very beneficial in terms of both primary and secondary effects, only about 3,000 patients have been treated, despite the fact that an estimated 310,000 persons suffer from iNPH. The current low recognition of the disease may be responsible for this situation. A survey to determine the actual awareness of iNPH has shown that the rate is 58 percent among care managers10 and 11.9 percent among the general population.11 This suggests that many patients do not receive appropriate medical attention because their conditions are attributed to senility. The diagnostic yield of iNPH by specialists is high, i.e., 58 percent and 48 percent for neurosurgeons and neurologists, respectively, whereas the corresponding rate is 7 percent for psychiatrists and 7 percent for primary care physicians.12 In a survey, 57 percent of Japanese aged 60 and over responded that they would first visit their regular doctor (kakaritsukei) rather than specialists if they thought they might have signs of dementia. Thus, it is probable that many cases of iNPH are overlooked.11 The disease is commonly undetected among institutionalized elderly persons in geriatric health services facilities and special nursing homes. Therefore, it is necessary to increase the awareness of iNPH among care managers, helpers, and personnel in clinics and other primary care facilities. Early detection of iNPH and early initiation of treatment may improve the independence and quality of life of the patients, while decreasing the burden of nursing care and greatly contributing to a reduction in social and economic costs.

Current Policy Multicenter studies of the symptoms and treatment of iNPH have been conducted by the Rare/Intractable Disease Project of the MHLW and the Japan Society of Normal Pressure Hydrocephalus. Methods for determining the surgical indications and procedures for iNPH have already been established. Social systems have been established to provide support and care for dementia patients. One example is the Pharmaceuticals and Medical Devices Agencyâ&#x20AC;&#x2122;s establishment of 150 dementia care centers nationwide. Dementia support training programs are being prepared by local governments to create a support system for iNPH in the private sector. There are currently no noteworthy changes in policies concerning gait impairment and urinary incontinence; these conditions are managed within the framework of currently available services, such as those covered by long-term care insurance.

Policy Changes in the Past Year: No Change In response to the general inquiry at the plenary meeting of the metropolitan assembly regarding how to address iNPH, the Tokyo metropolitan government delegated to the medical institutions the tasks of increasing awareness of iNPH and improving the ways this type of dementia is treated. Other than this, there has been almost no change in May 2013

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administrative efforts concerning iNPH. No effective policies have been established for the creation of procedures for preventing falls/fractures and bedridden status through the diagnosis and treatment of iNPH. Recommendations • Rather than a broad reimbursement category for cerebrospinal fluid shunting technique, reimbursement should be specific for iNPH in order to make the number of procedures clear and promote appropriate treatment. Specifically, increasing reimbursement for cerebrospinal fluid shunting of iNPH would effectively promote treatment while generating the benefits of increased patient and family quality of life and decreased spending on home nursing care.

• Although medical efforts to diagnose and treat iNPH are being promoted, less than 1 percent of patients with the disease receive appropriate medical care. The low degree of awareness concerning iNPH either causes patients’ symptoms to be mistakenly attributed to senility, or leads to the possibility of iNPH being overlooked or misdiagnosed by healthcare providers. Prior to raising general public awareness about iNPH, heightened awareness must be encouraged among medical and social sciences professionals who care for the elderly.

• Establish a system to promote cooperation between institutions and local communities, so that local administrative authorities participate in the promotion of iNPH diagnosis and treatment.

• Carry out diagnostic imaging with head CT/MRI for elderly patients who have qualified to receive home nursing care under Japan’s national home nursing care system and, in addition, conduct procedures to certify the need for long-term care and obtain the written opinion of the physician in charge.

• Document the need for diagnostic imaging in cases of iNPH and provide guidance to local medical associations in order to raise awareness among medical professionals who care for the elderly.

• With respect to coordinating the certification of long-term care when needed by patients, provide clear instructions to comprehensive support centers and dementia care centers to ensure a better understanding of iNPH care.

• Subsidize the cost of head CT/MRI for persons certified to be in need of long-term care.

• For elderly persons who have fallen and suffered a fracture, make a special effort to prevent additional falls and bedridden status, and to increase the survival rate by remedying gait impairment via proper diagnosis and treatment of iNPH. • Add the cost of head CT/MRI in elderly persons who have fallen and suffered a fracture to the Diagnosis Procedure Combination (DPC) payment system, to allow reimbursement of the cost.

• Require national and local administrative authorities to aggressively conduct an iNPH public relations campaign targeting the general public.

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References

1. National Institute of Population & Social Security Research. 2009 Population information material; United Nations. 2008 UN estimates.

2. Masaaki Hashimoto, Masatsune Ishikawa, Etsuro Mori, and Nobumasa Kuwana. Diagnosis of idiopathic normal pressure hydrocephalus is supported by MRI-based scheme: a prospective cohort study.

Cerebrospinal Fluid Research. 2010; 7:18.

3. Guidelines for management of idiopathic normal pressure hydrocephalus. 2011. Ver. 2.

4. Arai, H. Brain 21.2011 14(2) (in Japanese).

5. Ishikawa, M. Evaluation of the medico economic effect of the treatment of iNPH. Brain 21. 2011.

14(2).

6. Tsuboi, M., et al. 2007. J Bone Joint Surg Br 89(4):461.

7. Japan National Council of Social Welfare 2000 Longevity Social Welfare Fund Project. Case examples of welfare services (in Japanese).

8. National Consumer Affairs Center of Japan. 2000. Consumer consultation regarding nursing care services and commercial products (in Japanese).

9. Fukushima, M. 2011. Medical mishaps case file. Nanzando Co., Ltd. (in Japanese).

10. Care Management Online. 2011. Consciousness survey regarding iNPH (in Japanese).

11. GF senior database telephone survey. Consciousness survey regarding iNPH (in Japanese).

12. Survey of clinical practices for iNPH. m3, 2010 (in Japanese).

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19. Aging Society: 300,000 Persons May Have iNPH l Japan is a super-aging society. In 25 years (125 years in France) the elderly increased from 7% to 14% of the population. l There are potentially 319,000 (1.1% of the population aged 65 and over) iNPH patients in Japan

% Changes (Past and Estimated) in the 65-and-over Population France Germany UK Italy Sweden Korea USA Japan

Japan

France

Sources: IPSS, “2009 Population Information Material”; UN, “2008 UN Estimates.”

19. Curable Cause of Dementia, Gait Impairment, Incontinence l iNPH is caused by a disorder in cerebrospinal fluid circulation that results in ventricular enlargement in the absence of elevated cerebrospinal fluid (CSF) pressure.

Symptoms of iNPH

Estimated iNPH Patients Parkinson’s disease

150,000

iNPH

310,000

Alzheimer’s disease

Difficulty walking Symptoms Gait Impairment, cognitive decline, urinary incontinence

Stronger dementia symptoms Diagnosis by Head CT/MRI

Frequent need to go to the bathroom Examination

1,000,000 0.2

0.4

0.6

0.8

1 m

Source: Mori E, Tohoku Univ., 2009.

Shunting Surgery Showed 80 = improvement, 13% became independent

Cerebrospinal fluid tap test

Treatment of iNPH with Cerebrospinal Fluid Shunting Technique: 3,000 Cases Annually

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20. Early Detection of Abdominal Aortic Aneurysm

Situation One disease area for which early detection has the potential to reduce the mortality rate in Japan’s aging society is Abdominal Aortic Aneurysm (AAA). AAA is a disease whereby localized dilatation (ballooning) of the abdominal aorta exceeds the normal diameter.

In many cases, the dilation occurs gradually. The risk is highest for male smokers over the age of 65 who have hypertension.1, 2 The most effective means of AAA prevention is reduction of risk factors: smoking cessation, and control of high blood pressure and high cholesterol.2 AAA patients rarely experience symptoms besides pain in the abdomen or lower back.

The risk of rupture depends on extent of dilation of the patient’s abdominal aorta. The normal diameter of an abdominal aorta is 1.5 to 2 centimeters. However, if the diameter exceeds 3 centimeters (150 percent of normal), it is defined as an aneurysm with risk of rupture.1, 2 In general, any AAA over 5 centimeters diameter is a candidate for surgery.

If the abdominal aorta ruptures, the risk of death is up to 90 percent.3 AAA can be diagnosed with noninvasive imaging tests including ultrasound and computed tomography (CT) scan.2 Results of the Multicentre Aneurysm Screening Study undertaken in the U.K. over a four-year period provide reliable evidence of benefit from screening for AAA in terms of National Health Service criteria for quality of life and mortality.4 Japan is believed to have more than 1.2 million AAA patients but incidence is still unknown because most cases in Japan are discovered as a result of ruptures or unexpected detection through abdominal ultrasound screenings.6 Research on AAA is currently underway in Japan targeting hypertension patients over the age of 60.

Recommendations • Promote better understanding of AAA among citizens and health professionals in order to increase the rate of early detection of AAA among the high-risk population and provide adequate disease management.

• Provide incentives for AAA screening.

• Support the development of clinical guidelines for screening and diagnosis of AAA. Case Study: U.S. SAAAVE Act The U.S. Preventive Services Task Force recommends screening for AAA using ultrasound imaging one-time for men aged 65–75 years that have ever smoked, even if they have no symptoms.5 Since January 2007, the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act passed by the U.S. Congress entitles all new Medicare enrollees with a history of smoking to a free, one-time ultrasound screening for AAA as part of the Welcome to Medicare Physical.7

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References 1.

2.

3.

4.

5.

6.

7.

Abdominal aortic aneurysm, by Mayo Clinic staff. http://www.mayoclinic.com/health/abdominal-aortic-aneurysm/DS01194.

Aortic Aneurysm Fact Sheet, Centers for Disease Control and Prevention. http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/docs/fs_aortic_aneurysm.pdf.

Clouse WD, Hallett JW, Jr., Schaff HV, Gayari MM, Ilstrup DM, Melton LJ, 3rd. Improved prognosis of thoracic aortic aneurysms: a population-based study. JAMA. 1998;280(22):1926–1929.

Lancet. 2002. Nov. 16;360(9345):1531–9. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA, Thompson SG, Walker NM; Multicentre Aneurysm Screening Study Group.

Guirguis-Blake J, Wolff TA. Screening for abdominal aortic aneurism. Am Fam Physician.

2005;71(11):2154–2155.

Impact of the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act on Abdominal Ultrasonography Use Among Medicare Beneficiaries, Jacqueline Baras Shreibati, MD; Laurence C. Baker, PhD; Mark A. Hlatky, MD; Matthew W. Mell, MD. Arch Intern Med. Published online September 17, 2012. doi:10.1001/archinternmed.2012.4268 Japanese language website about AAA. aortic aneurysm.com. www.mdtendovascular.com/index.html.

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20. What is An Abdominal Aortic Aneurysm?

An abdominal aortic aneurysm located below the arteries that supply blood to the kidneys.

Sources: http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_aortic_aneurysm.htm and http://www.nhlbi.nih.gov/

20. Smoking Is Associated with a 3- to 5-fold Increase in the Prevalence of AAA Prevalence of AAAs Greater Than 3 cm by Age and Smoking History

Source: Fleming C, Whitlock EP, Bell TL, Lederle FA. Screening for abdominal aortic aneurysm. AHRQ Pub. No. 05-0569-B. 2005. Cited in U.S. CDC AAA Fact Sheet at www.cdc.gov

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20. An Estimated 1,229,480 AAA Patients In Japan Risk of Rupture Increases If Untreated 80 70 60

Risk of Rupture for Untreated AAA After 5 Years

75%

50 40 30

35%

25%

20 10 0

5-5.9cm

6-7cm

Size of AAA

>7cm

• AAA rupture leads to death in 82% of cases.

• 50% of patients with an untreated AAA over 5.5 centimeters die within five years due to rupture.

• A one-time screening can identify AAA most clinically appropriate for treatment and decrease the risk of death by 70%.

• Less than 50% of AAA rupture patients are still alive by the time they arrive at the emergency room. Of these, only 50% survive based on current treatment standards.

Source: Estimate based on March 2013 Population Estimates from Japan’s Ministry of Internal Affairs and Communications.

20. AAA Screening Saves Lives Deaths of Men Aged 64 to 81 Screened for AAA Compared to Control Group

Source:_R. A. P. Scott, et al. European Journal of Vascular and Endovascular Surgery 2001; 21:535-40

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21. Reduce the Risk of Cerebral Infarction by Early Detection of Carotid Plaque

Situation Cerebrovascular disease had been ranked as the main cause of death in Japan during the three decades following World War II. Since the 1970s, however, there has been a decline in the number of deaths resulting from cerebrovascular disease. This is the result of activities conducted by both the government and local entities to disseminate information regarding the dangers of high blood pressure, and is also a consequence of the expanded use of innovative technologies for diagnostic imaging and minimally invasive treatment and the availability of new medicines. According to the Ministry of Health, Labour and Welfare (MHLW), over the past 16 years, deaths from cerebrovascular disease have declined 12 percent, while over the past 13 years, there has been a 23 percent drop in the number of cerebrovascular disease patients.

Nevertheless, there has been a gradual increase in the incidence of cerebral infarction.

While in 1960, cerebral infarction affected 10 percent of those with cerebrovascular disease, the ratio has now risen to 60 percent. This is generally recognized as being the result of an increase in the consumption of Western food, as well as in the number of patients with diabetes and hyperlipemia. Given that patients with cerebral infarction are more likely to require hospitalization for treatment, while those with other types of cerebrovascular disease may not, the government recognizes that, in order to curb spiraling medical expenses, cerebral infarction is one of the diseases that must be tackled.

According to a survey conducted by the MHLW, patients and care givers stated that cerebrovascular disease was the main reason that nursing care was required (accounting for 24 percent of all care given in 2010). Thus, cerebral infarction is a key factor in the transfer of patients from care in hospital to nursing care at home.

The main causes of cerebral infarction are stenosis (the occlusion of vascular lumen by atherosclerotic plaque) and arterial embolism, caused by vulnerable plaque.

Atherosclerosis frequently occurs in the carotid arteries, which can be effectively examined using MRI and ultrasound systems to determine the condition of the plaque and even its vulnerability. These forms of screening enable doctors to diagnose conditions and to make decisions regarding surgical treatment, and they are increasingly being used for minimally invasive examinations, as well as to detect causes of cerebral infarction at the early stages. Working groups organized by medical specialists of the Japan Brain Dock Society and the Japan Academy of Neurosonology are working both to improve the precision of examinations and to popularize the use of MRI and ultrasound in hospitals and clinics.

Current Policy The government continues to take steps designed to prevent, and for the early detection of, cerebral infarction. Some local governments even subsidize medical examinations of the brain, while in the private sector, companies and health insurance associations have prepared programs whereby financial support is extended to persons wanting examinations for cerebral infarction. Moreover, in Japan, every effort is made to ensure that the opportunity to undergo such examinations is available to all, irrespective of domicile or means. In light of the governmentâ&#x20AC;&#x2122;s track record in promoting screening for other disease areas, there is potential to do more nationwide to increase the accessibility of, and to standardize, screening procedures for carotid plaque.

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Recommendations â&#x20AC;˘ In order to increase the possibility that carotid plaque will be detected early, and to maximize the quality of life for all citizens, the government needs to increase public awareness concerning the importance of examination for carotid plaque. â&#x20AC;˘ Financial support programs should be developed throughout the country, to expand the opportunities for individuals to undergo examination for carotid plaque.

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21. Deaths and Patients Caused by Cerebrovascular Diseases # of Patients (1,000 ppl)

# of death (1,000 ppl)

2,000

200

1,750 1,500

175 # of Patients

1,250 1,000

150 # of Death

750 500

125

250 0

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

100

Source: Ministry of Health, Labor, and Welfare. (Trend of Medical Institutions.

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21. Vessel Wall Imaging MRI

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22. Prevent Fractures Due to Osteoporosis

Situation Osteoporosis is a disease in which the bones become fragile, leading to a higher incidence of fractures of the vertebrae, hip, and other bones. According to the Japan Osteoporosis Society and the Japan Osteoporosis Foundation, it is estimated that, in Japan, there are approximately 11 million patients with osteoporosis, among whom about 8 million are women. The incidence of osteoporosis dramatically increases in women during the first half of their fifties, after menopause, and in men during the latter half of their sixties.

In order to remain strong, bones are constantly rebuilding through a cycle of breaking down old bone (bone resorption) and building new bone (bone formation). However, for a variety of reasonsâ&#x20AC;&#x201D;including aging, menopause, poor diet, and lack of exerciseâ&#x20AC;&#x201D;the bone turnover balance can become disrupted, causing bone resorption to outpace bone formation, resulting in an overall decrease in bone mass.

In most cases, osteoporosis progresses without obviously visible symptoms. However, with the progression of bone mass decrease and micro-cracks, subtle symptoms, such as a slight loss of height and lower back pain, begin to appear. Decreased bone mass and microcracks increase the risk of fractures, even from relatively small impacts, such as from falls.

Fractures due to osteoporosis mainly occur in the vertebrae, femoral neck of the hip, and radius of the arm. Recently, there has been an increase in the number of people who experience a hip fracture, which causes a severe decline in quality of life. Furthermore, it has become evident that fractures and falls among the elderly are the main reason that people require nursing care or become bedridden. Thus, fractures and falls have become serious issues in aging societies.

The belief that osteoporosis is strictly a problem in the West has been revealed to be a myth. Among the large elderly population in Asia, osteoporosis and osteoporotic fractures are increasing. According to The Asian Audit, published in 2009 by the International Osteoporosis Foundation (IOF), the incidence of hip fractures had increased two- to threefold in most Asian countries during the previous 30 years. In Japan, between 1986 and 1998, the incidence of hip fractures increased 1.6-fold in men and 1.5-fold in women.1 The IOF believes that osteoporosis is under-diagnosed and under-recognized due to a lack of structured government-sponsored awareness programs for both physicians and the public, despite the serious consequences and social burden of the disease. Among the 14 Asian countries that participated in The Asian Audit, four (Singapore, Indonesia, Taiwan, and Vietnam) have government policies that recognize osteoporosis as a major health concern. Japan, however, does not yet recognize the disease as such.

Life expectancy is markedly reduced and the chance of spending the rest of oneâ&#x20AC;&#x2122;s life bedridden is significantly higher for elderly patients who suffer hip fractures.2, 3 Moreover, research shows that once a vertebral fracture occurs due to osteoporosis, it is highly likely that subsequent fractures will occur. This makes it extremely important to prevent fractures and to educate both patients and medical professionals about the significance of early diagnosis and the early start of treatment.4, 5, 6, 7 According to the November 2011 National Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan, osteoporosis has attracted the interest of 64.7 percent of Japanese adults, of whom only 60 percent have taken any action to prevent it.8 May 2013

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Current Policy The Ministry of Health, Labour and Welfare considers osteoporosis checkups to be one of the pillars of its health-promotion projects for people over the age of 40. Currently, osteoporosis checkups are being conducted nationwide at five-year intervals for women between the ages of 40 and 70. However, the rate of those who participate in the checkups is relatively low.

Recommendations • Educate both the public and medical professionals about the significance of early diagnosis and the earlier start of treatment. Once there is a vertebral fracture due to osteoporosis, it is highly likely that subsequent fractures will occur. Therefore, it is extremely important to prevent the first fracture.

• Encourage more people to participate in osteoporosis checkups by conducting related educational activities, such as providing information about the serious consequences of fractures resulting from osteoporosis.

• Carry out osteoporosis prevention campaigns focusing on enhancing the public’s awareness of osteoporosis, and increasing the rate of participation in checkups at the national and local-government levels.

• Establish a referral system between the facilities conducting osteoporosis screening and larger medical institutions that could provide treatment for those who have been identified through the screening checkups as having problems. This would allow earlier diagnosis and treatment of the disease, and improve individuals’ chances of maintaining a better quality of life for longer.

References

1. International Osteoporosis Foundation. 2009. The Asian Audit: Epidemiology, Costs and Burden of Osteoporosis in Asia 2009.

2. Cooper, C., et al. 1993. Am J Epidemiol 137(3):1001.

3. www.ncbi.nlm.nih.gov/pubmed/15086646.

4. Ettinger, B., et al. 1999. JAMA 282(7):637–645.

5. Black, D.M., et al. 1999. Journal Bone Miner Res 14(5):821–828.

6. Ross, P.D., et al. 1993. Osteoporosis Int 3(3):120–126.

7. Lindsay, R. 2001. JAMA vol. 285.

8. ACCJ. 2011. National survey on prevention, early detection and the economic burden of disease in Japan.

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22. Osteoporosis Patients in Japan The onset of osteoporosis dramatically increases in women in the first half of their 50s, after menopause, and in men in the latter half of their 60s.

Source: Osteoporosis in Women and Men, Yamamoto, Osteoporosis Jpn 7:10-11, 1999.

22. Rising Incidence of Hip Fractures Incidence of Hip Fractures in Japan

Male Female

Source: Fourth National Survey of Femoral Neck Fracture Incidence, Reported in Weekly Japan Medical News, 2004, Issue 4180, pp 25-30.

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22. 60%+ of Adults Interested in Osteoporosis; Top Ratio for Females, Older Persons Q: How interested in osteoporosis are you? (Single answer) Interested 64.7%

Not Interested 16.8%

51.9%

25.4%

76.6%

8.9%

46.3%

27.8%

50.9%

23.2%

58.6%

18.3%

69.2%

14.9%

75.1%

12.4%

82.7%

7.8%

76.9%

9.1%

\OInterested \OSlightly interested \ONeither nor \ODo not know \ONot very interested \ONot interested Source: ACCJ National Survey on Prevention, Early Detection & the Economic Burden of Disease in Japan, November 2011.

22. No Preventive Steps by 40% Interested Adults; 30% Take More Calcium, Want Family to Do So Q: What actions have you taken since becoming interested in osteoporosis?

(Multiple answers) (Asked of those interested, slightly interested in osteoporosis.)

(n=3236)

Source: ACCJ National Survey on Prevention, Early Detection & the Economic Burden of Disease in Japan, November 2011.

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23. Increase Breast Cancer Screening Levels

Situation According to Japan’s National Cancer Center, breast cancer is the leading killer among Japanese women between the ages of 30 and 64.1 Increasing the mammography breast cancer-screening rate would facilitate early intervention that could improve patient quality of life and bring cost savings. Breast cancer patients diagnosed in the early stages have a 96 percent survival rate over five years, and treatment costs of around ¥760,000 per patient. A patient with breast cancer that is not detected until the later stages (when it has metastasized) has only a 28 percent survival rate over five years. Such a case can cost ¥4 million or more per patient for surgery, chemotherapy, and radiation treatment.2 Although incidence and mortality rates are both rising in Japan, the two-year mammography screening rate in the country is only 24.3 percent, compared with an OECD average of 62.2 percent.2, 3, 4, 5 Based on the results of a 2011 national opinion survey of 921 women that had not had a mammogram screening in the past two years, 31.4 percent said they would be likely to be screening if they found lumps and 27.9 percent said they would be screening if it were conveniently included free as part of their annual health checkup.6 Of 374 women that did have a mammogram screening in the past two years, 78.3 percent said they were screened because of their own decision while only 11 percent said they were screened because of a local government recommendation, only 8.6 percent said they were screened because they received a free screening coupon from their local government, and only 8.3 percent said they were screened because of an employer requirement or recommendation.6 Current Policy The government of Japan has set an admirable national goal of increasing to 50 percent the percentage of women over the age of 40 who have undergone breast cancer screening during the previous two years. In 2009, the Japanese government made progress by announcing a new five-year program to send coupons for free screening to women aged 40, 45, 50, 55 and 60. So far, only a small fraction of the target group actually receives the free screening because of low public awareness levels and the fact that the free screening cannot be conveniently received during annual checkups provided by private health insurance associations.

Recommendations • Amend the National Health Insurance Law of Japan to require that breast cancer screening be included among the mandatory items for women over the age of 40 in the annual special health screening (tokutei kenshin) system.

• Send coupons for free screening to women over the age of 40 or cover breast cancer screening in the national health insurance system.

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References

1. National Cancer Center, Center for Cancer Control and Information Services. Population Trend Statistics (Ministry of Health, Labour and Welfare Statistical Information Department). World Health Organization Mortality Database.

2. Japan Ministry of Health Labour and Welfare. 2010. National basic life survey results, announced July 12, 2011 www.mhlw.go.jp/stf/houdou/2r9852000001igt0.html.

3. OECD. www.oecdtokyo.org/pub/statistics_japan.html.

4. U.S. National Cancer Institute. Surveillance epidemiology and end results, breast cancer fact sheet. http://seer.cancer.gov/statfacts/html/breast.html/.

5. Ministry of Health, Labour and Welfare. 2007. Regional area and aged persons health report. Key findings for Japan. www.oecd.org.

6. ACCJ “National Survey on Prevention, Early Detection & the Burden of Disease in Japan,” November 2011.

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23. Breast Cancer Screening Rates Lower Than OECD Average Free National Breast Cancer Screening Launched in 2009

Scope: Women aged 40, 45, 50, 55, and 60 Funding: 100% by central government Japan Goal: 50% screening rate by 2011 Recruitment: Send coupons to eligible women XRP

24Q3P

XVP 62.2P

Mammography screening rates in Japan rising, but still low

Sources: http://www.mhlw.go.jp/stf/houdou/2r9852000001igt0.html, http://www.oecdtokyo.org/pub/ statistics_japan.html.

23. Most Women Screened for Breast Cancer in Past Two Years Did So on Own Initiative Q: Why did you have a mammogram in the past two years? (Multiple answers)

(n=374) Source: ACCJ National Survey on Prevention, Early Detection & the Economic Burden of Disease in Japan, November 2011.

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23. 27.9% of Women with No Mammogram in 2 Years Say Key Is Inclusion in Annual Health Checkup Q: What would make you more likely to have a mammogram in the next two years? (multiple answers) (Women who had not had a mammogram in the previous two years were asked.)

(n=921) Source: ACCJ National Survey on Prevention, Early Detection & the Economic Burden of Disease in Japan, November 2011.

23. Breast Cancer Screening: Cost Effective; Saves Lives

Breast cancer diagnosed in early stages l Has 96% survival rate over five years l Costs about ¥760,000 to treat

Top three reasons women do not have a mammogram

Breast cancer diagnosed after it has metastasized l Has a 28% survival rate over five years l Costs up to ¥4 million to treat

l Sense no need, as have no lump l Lack of opportunity l High fees

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24. Increase Cervical Cancer Screening Levels

Situation Early detection and early intervention are critical for the prevention of cervical cancer. In Japan, out of the 8,000 cases of cervical cancer diagnosed annually, roughly 2,500 women will die. Japan has seen a sharp rise in the number of patients with cervical cancer in their twenties and thirties, and a growing mortality rate. Cervical cancer is the only type of cancer whose incidence can be reduced with a vaccine, which is already in use in more than 100 countries and has recently become available in Japan. Because the human papilloma virus (HPV) is the dominant cause of cervical cancer, regular Pap testing, early HPV testing when recommended, and early vaccination can work together effectively to prevent cervical cancer. In the United States, regular Pap testing has been successfully adopted and recognized as one of the most effective cancer screening tests. In 2010, the cervical cancer screening rate in Japan was 24.3 percent, less than half the 64 percent average for Organization for Economic Co-operation and Development (OECD) member countries.1 Current Policy In 2009, the government of Japan made progress in improving cervical cancer screening by announcing a new five-year program to send coupons for free screening to women aged 20, 25, 30, 35, and 40. To date, only a small fraction of the target group has been receiving free screening due to low public awareness and the fact that the free screening cannot be received as part of the annual screenings provided by private health insurance associations. In 2011, the Japanese government took a further step by funding the implementation of a National Cancer Initiative, targeting breast, colon, and cervical cancer. To further enhance cervical cancer prevention, HPV vaccination for girls between 10 and 14 years of age was also funded. Widespread public confusion remains, however, concerning how vaccination and cervical cancer testing combine to prevent cervical cancer.

Recommendations • Amend the National Health Insurance Law of Japan to fund and include cervical cancer testing in health exams for all women between the ages of 20 and 40.

• Increase funding for raising cervical cancer awareness to meet Japan’s goal of a 50 percent cervical cancer screening rate by 2017.

• Increase funding to better educate women on how the three latest technologies to fight cervical cancer—HPV vaccination, HPV testing, and Pap testing based on liquidbased cytology (LBC), all currently available in Japan—can work together to achieve comprehensive cervical cancer prevention.

• Promote use of the latest cervical cancer-fighting technologies, including HPV vaccination, HPV testing and, most critically, LBC cancer cell screening, to increase accuracy and reduce the amount of retesting for cervical cancer. In particular, the combined use of HPV testing and cytology has become a trend in recent years and, therefore, it is recommended that the conventional cytology method be converted to liquid-based cytology as soon as possible as a first step toward more universal adoption.

• Promote the use of automated screening systems, which are commonly used in the United States and Europe to ensure accuracy control; and promote streamlined operations for the increased manpower expected in labs as a result of an increased screening rate in the future.

Reference 1.

Ministry of Health, Labour and Welfare. 2010. National lifestyle basic research report (July 12). www.mhlw.go.jp/stf/houdou/2r9852000001igt0.html.

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Per 100,000

24. Incidence Rate of Cervical Cancer (including intraepithelial carcinoma)

1978

1998

1988

Age Source:

(1998 )

24. Cervical Cancer Screening Rate in Developed Countries Japanâ&#x20AC;&#x2122;s Cervical Cancer Prevention Problem is the Low Screening Rate Note: Taiwan (a non-OECD country) has reached a 70% Screening(%) Rate (%) A/ screening rate and a reduction in the mortality rate 82.6

74.9 72.8 72.5 72 69.8 69.6 69.4

60.5

55.9

49

40.6

36.7

Japan

Italy

South Korea

Poland

Germany

Australia

Denmark

Netherlands

UK

Sweden

Norway

Canada

France

23.7

US

90 80 70 60 50 40 30 20 10 0

Source: Â&#x152;OECD Health Working Paper No. 29, 2007Â?

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Percentage of Women

24. Comprehensive Cervical Cancer Prevention Three Technologies Work Together

Starting at 20 every 1-2 years for all women

for all 11-14, 15 – 45 yrs. where possible

10

When recommended

Woman’s Age

24. Comprehensive Cervical Cancer Prevention After Age 10: Get HPV Vaccination!

After Age 20: Get Periodic Screening!

Woman’s Age May 2013

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25. Increase Hepatitis B Screening and Vaccinations

Situation Viral hepatitis is considered to be the most common contagious disease in Japan. Of the estimated three million patients and carriers of viral hepatitis B (HBV) and hepatitis C (HCV) in Japan, between 1.2 million and 1.5 million (approximately one percent of the population) are thought to be infected with HBV.1, 2 Furthermore, HBV and HCV are thought to cause approximately 90 percent of cases of liver cancer, the third most common type of cancer in Japan.3 Since the cause is clear, liver cancer can be considered a preventable type of cancer.

However, the lack of obvious symptoms means that it is difficult for patients to notice that they have the disease, enabling the condition to advance. Between 70 percent and 80 percent of patients (approximately 1 million people) do not know that they are infected with HBV or HCV.4 If a patient realizes that he or she is infected and receives appropriate treatment with regular testing, the patient’s chances of developing liver cancer can be significantly reduced.

HBV is transmitted via blood and bodily fluids. Many people have been infected without realizing it, since there have been various transmission routes, including mother-to-child transmission, mass vaccinations conducted in the past, and sexual transmission. The main reason for the low awareness is that people do not have comprehensive information about the risks and transmission routes, or which hospitals provide diagnosis and treatment.

In 1986, a Mother-to-Child Transmission Prevention Program was started as an HBV infection control measure, whereby newborn babies of mothers carrying the virus were vaccinated. Following introduction of the program, the HBV carrier rate declined to 0.04 percent. However, there remains the issue of infection due to other routes, such as father-to-child vertical transmission and child-to-child horizontal transmission at childcare centers. Further, in recent years, an acute viral inflammation—in the form of a sexually transmitted disease brought from other countries—due to the hepatitis B virus of genotype A has been rapidly spreading. It is a new concern that acute infection with hepatitis B virus genotype A, which has a higher rate of persistent infection than other genotypes, is spreading in Japan. Furthermore, it has been reported that when some patients with a history of hepatitis B virus received chemotherapy and immunosuppressive therapy, the hepatitis B virus was reactivated.5 The World Health Organization (WHO) recommends that universal immunization with the hepatitis B vaccine should be conducted in all nations. While most countries have introduced universal vaccination programs for children (newborn babies and school children), in Japan vaccinations are given only to infants born to mothers infected with HBV.6 Current Policy In January 1986, the government of Japan started a vaccination program to prevent mother-to-infant infection with HBV in the case of infants whose mothers are infected with the virus. The program has been effective in preventing the vertical transmission of HBV from mothers to infants, but vaccination for the rest of the population is not included in the program. Therefore, horizontal HBV transmission remains an issue. Unless tested, it is very difficult for patients to recognize that they have HBV.

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On November 19, 2009, the Hepatitis Basic Law was enacted because hepatitis diseases are considered to be the most contagious diseases in Japan, and specific measures were considered necessary nationwide. According to this law, hepatitis control measures are a task of national importance in order to respect the human rights of infected patients.

The law defines the basic principles of hepatitis control and clarifies the responsibilities of Japanese national and local governments in terms of ensuring comprehensive execution of measures for hepatitis prevention and early detection. The law also defines policies for the provision of economic support for treatment.

During the five years between 2002 and 2007, the Ministry of Health, Labour and Welfare (MHLW) encouraged Japanese people to be tested for both HBV and HCV on a regular basis (at the ages of 40, 45, 50, 55, 60, 65 and 70). However, data from 2005 revealed that the actual participation rate in HBV testing was only 24.9 percent (of the 4,848,053 people in the target age group, only 1,205,423 were tested). In 2007, data from the MHLW also showed that, during the same five-year period, out of 8,704,587 persons tested for hepatitis, 100,983 (1.16 percent) tested positive. Yet, it is estimated that only 30 percent of those who tested positive had a follow-up visit with physicians, although they were required, in principle, to undergo a second thorough examination.

Currently, patients across Japan can receive screening free of charge at health centers and designated medical institutions.7 Blood tests can reveal whether a patient is infected with the hepatitis virus. Testing can be done quickly and the results are produced within a few weeks. In addition, in May 2011, the MHLW revised the basic guidelines for hepatitis testing to enable hepatitis screening tests to be included in employees’ annual medical checkups.

In May 2011, the MHLW issued fundamental guidelines for the promotion of hepatitis virus screening that state “all Japanese should receive the screening test at least once” and “a system to provide broad screening services, and urge people to use the services, needs to be established.” Free screening is still not available for employees who receive health insurance through the health insurance associations of private employers. There is also concern about the potential of discrimination or bias against employees who are found to be infected with the hepatitis virus. Therefore, only a limited increase in the screening rate is expected.

Recommendations In addition to those who have never been tested for the hepatitis virus, it is strongly recommended that the following persons undergo an HBV test: • Anyone who has had a health check at which tests of liver function revealed abnormal AST or ALT values, but who has not since been examined by a doctor or undergone a hepatitis test.8 • Anyone born before 1985 (during that period there were no measures in place to prevent mother-to-child transmission).

• Anyone who has an HBV carrier in his or her family (especially the mother or siblings).

Measures should be implemented to further increase screening levels among the general public in Japan, which may result in a decrease in the prevalence of HBV in the country: • Introduce effective hepatitis education programs across Japan for adults and students, based on public- and private-sector collaboration.

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•

• • •

Implement hepatitis screening tests as standard in employees’ annual medical checkups. Currently, hepatitis screening tests are only recommended for employees’ medical checkups, but they should become standard requirements. Public funds should be provided so that there is no need for co-payment or fees.

National and local numeric goals should be set for hepatitis screening rates.

Private companies, health insurance payers, and health advisors should cooperate to recommend appropriate treatment without discrimination if employees test positive for the hepatitis virus.

As a preventive measure, the Japanese government should introduce a universal hepatitis B vaccination program for all children. Vaccination is an important means of infection control, and the risk of horizontal transmission remains high in Japan.

References 1.

2.

3.

4.

5.

6.

7.

8.

Ministry of Health Labour and Welfare. www.mhlw.go.jp/seisaku/2009/03/03.html.

Izumi, Namiki. 2007. Golden Handbook of Hepatology. Tokyo: Nankodou Publishing Co., Ltd. National Cancer Center. 2009. Cancer Information Service. http://ganjoho.jp/public/statistics/pub/statistics01.html.

Japan Medical Journal. 2009. (May 30) 4440:43–55.

Ministry of Health, Labour and Welfare Hepatitis B Vaccine Task Force. www.mhlw.go.jp/stf/shingi/2r98520000014wdd-att/2r98520000016rr1.pdf.

Japan National Institute of Infectious Diseases. 2010. Hepatitis V Vaccine Fact Sheet (July 7). www.mhlw.go.jp/stf/shingi/2r9852000000bx23-att/2r9852000000bxqf.pdf and www.kanen.ncgm.go.jp/forpatient_hbv.html.

Free testing available as of May 2011. A portion of the cost has to be paid by some patients, including those who have had an HBV test in the past.

AST/ALT values: the standard values used vary by institution, but an individual with absolutely no abnormality of liver function will display a value of 30 IU/L.

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25. Only Half the Adults in Japan Have Been Screened lď Źâ&#x20AC;Ż Japanese government has provided free hepatitis screening since 2002 at the time of regular health checkup services by municipal governments. Free screening was first provided at public health centers and later also at hospitals and clinics. lď Źâ&#x20AC;Ż Need to further increase screening rate, especially for people aged 40 and over.

HCB Screening Rate: Est. 57%

HCV Screening Rate: Est. 48% Yes, I have had test (selfreported) 18%

Yes, I have had test (selfreported) 18% No, I have not or do not know 42%

No, I have not or do not know 52% Tested at time of surgery, pregnancy, blood donation 40%

Tested at time of surgery, pregnancy, blood donation 30%

ij79.)

Source: National Survey on Getting-tested Status of Hepatitis Screening, MHLW, 2011. (Interviewed 74,000 Japanese people aged 20 through

25. Japanâ&#x20AC;&#x2122;s Free Screening Program Has Helped, But A Significant 2 ch 9j Bvtqh$#F/ LPGK Further Increase gUa_ Cannot Be Expected in the Current System.

6 h$#~ ~ * h$#T 7 KQGK A$# fehD$#]n_ MI& p :d^_ 9>1Y ,!X JQGJ rate is not Reason why a significant further increase in the screening k=knbZ_ expected <h)5r}s c)5^_ T$#] ď Źâ&#x20AC;Ż People n_ do not get tested because thereQGO is no hepatitis screening test provided as part of the annual NGO health checkups they take.

8 j1l Vg3'gXXa_ YV_

ď Źâ&#x20AC;Ż Even if people know free hepatitis screening program is available,

@? 0H hx}y|tujRSc they do not get tested because theyNGN do not think they are infected. ~ -%Cch( $#p1a_

Reason Not Screened for Hepatitis

(%)

No good reasonZaX\YfXa_Xk or chance

LQGJ

in.g \bVm$9zw{ gfV Not menu of annual check up

LOGL

Donâ&#x20AC;&#x2122;t think I am infected 4 i "^bVfVd WXk

KPGK

$#%Cj YoXkfVXk Donâ&#x20AC;&#x2122;t know where to get tested

It costs money

KKGO

;+YXXmXk

JLGP

It is inconvenient to get tested $#gV[hYE `Xk I am too busy

^VXk

JJGO PGQ

2011 MHLWâ&#x20AC;&#x2122; National Survey on Getting-tested status of Hepatitis Screening (Interviewed 74,000 Japanese people aged 20 thru 79 years old) J

May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 119

25. Providing Hepatitis Screening as Part of Annual Health Checkups is Most Effective ď Źâ&#x20AC;ŻMany people who have had hepatitis virus screening explained that the reason they were screened was that it was part of their annual health checkup. Â&#x20AC;38.2%Â . But most annual health checkups in Japan do not include hepatitis screening. ď Źâ&#x20AC;ŻThe best way to increase screening rate is to include free screening annual health check ups for people aged 40s or over nationwide for the specific period of time (five years for example), while protecting personal information protection.

Reason Screened for Hepatitis

(%)

It was in 9j Bvtqh$#F/gUa the menu of my regular health 2 ch check up _ Tested at time of surgery, pregnancy or 6 h$#~ ~ * h$#T 7A$# endoscopic test fehD$#]n_ MI& p :d^_ 9>1Y ,!Xk=k Received a notice from my local government nbZ_ health office

LPGK KQGK JQGJ

Tested when gave blood <h)5r}s c)5^_ T$#]n_ Because friend or family member had 8 j1l Vg3'gXXa_ YV_ hepatitis Learned of free screening program from @? 0H hx}y|tujRSc ~

municipal -%Cch( $#p1a_ government pamphlet or web site

QGO NGO NGN

Few people tested in current free screening program

2011 MHLWâ&#x20AC;&#x2122; National Survey on Getting-tested status of Hepatitis Screening (Interviewed 74,000 Japanese people aged 20 thru 79 years old)

K

25. Japan Is One of 16 Countries Without Universal Hepatitis B Vaccination

Above 80% rate of 3-dose vaccination (138 countries) Under 80% rate of 3-dose vaccination (36 countries) Has universal vaccination but rate unknown (3 countries) Not yet introduced universal vaccination (16 countries) SourceÂ&#x2018;Hepatitis B Vaccine Factsheet by National Institute of Infectious Diseases (July 7, 2010). http://www.mhlw.go.jp/stf/shingi/2r9852000000bx23att/2r9852000000bxqf.pdf.

SW

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26. Increase Hepatitis C Virus Screening and Treatment

Situation Since 1975, the number of deaths due to liver cancer has been rapidly increasing in Japan. Currently, nearly 30,000 people die of liver cancer annually, with about 80 percent of the fatal cases attributable to hepatitis C virus (HCV) infection.1 An estimated 1.9–2.3 million people aged 40 and over are HCV carriers. Many of them are thought to have been infected through medical procedures undergone prior to 1980, when the use of disposable instruments was not yet common, or from blood transfusions received prior to 1989, before mandatory HCV screening was initiated. The initially asymptomatic course of HCV infection can cause the condition to progress to chronic hepatitis, cirrhosis, or liver cancer before a person becomes aware that they are ill.2 Various effective new drugs are now available for the treatment of HCV infection. In 70– 80 percent of infected patients, administration of interferon-antiviral combinations for a certain period of time can enable the elimination of HCV from the body, thus preventing the progression to liver cancer.3 HCV infection can be easily detected through laboratory blood tests. Proper screening is crucial for determining a person’s HCV status in order to prevent the development of hepatitis, cirrhosis (hepatocellular damage) and liver cancer, and ensure that treatment is started in a timely manner.

In 2002, as part of a five-year plan, the government of Japan initiated a hepatitis virus-screening program as part of the health checkup services provided by municipal governments under the Health and Medical Service Act for the Aged. More than 9 million persons underwent screening, among whom 100,000 were infected with HCV.4 The health checkup services and free screening programs at health centers and medical institutions have continued to increase the convenience of getting tested. Although the five-year plan produced certain positive outcomes, there has been no dramatic increase in the screening rate.

According to national survey results announced by the Ministry of Health, Labour and Welfare (MHLW) in 2012, approximately half of those polled had not been screened. The main reasons given were that they had had no reason or chance to be tested, that testing was not offered as part of the regular health checkup, and that they believed they were not infected.5 Therefore it is unrealistic to focus on improving the convenience of HCV testing by increasing the number of locations where free tests are given, and to expect that people will voluntarily visit medical institutions to be screened. Over 800,000 infected people are still unaware that they are infected and continue to be at risk for serious liver disease.

Now, more effective hepatitis C treatments are being developed. When they are launched, it is expected that the treatment rate will increase, the duration of treatment will become shorter, and the severity of adverse reactions will decrease. However, advances in medical technology and the fight against liver cancer will not bear fruit unless screening is carried out to identify those infected with HCV. Thus, free HCV screening should be part of the general or annual special health screening programs (tokutei kenshin) that most Japanese people receive, rather than for the screening to require a separate trip to a medical institution. Hepatitis virus screening is only included in about 50 percent of the annual health screening programs offered to employees of large private companies by healthcare insurance associations. For others, even when screening is available, the entire cost must be paid by healthcare insurance associations or individuals, since hepatitis screening May 2013

Lengthening Healthy Lifespans to Boost Economic Growth | 121

for employees of most private companies is not part of the government’s national free screening program. As a result, the screening rate among employees of private companies is particularly low.

Current Policy The government of Japan has continued the hepatitis virus screening services as part of the health checkup program for local residents. In 2008, local general practitioners began to offer free screening services, which had previously been available only at local health centers. In 2009, the government also began paying part of the cost for one- to two-year interferon/antiviral combination therapy. As of April 2011, the patient’s out-of-pocket expenses for the treatment averages ¥10,000 per month. In May 2011, the MHLW issued basic guidelines for the promotion of control measures for hepatitis.6 According to these, all persons must undergo hepatitis testing at least once, and a system must be developed according to which anyone wanting to undergo hepatitis testing may do so.

Policy Changes in the Past Year: Slight Improvement In 2012 the central government renewed its matching budgets to subsidize local government that planned to provide mobile screening centers and individualized screening recommendations for people aged 40, 45, 50, 55, and 60. In the same year, the MHLW also started a three-year, nationwide campaign to promote hepatitis virus screening and treatment, including a very successful Japan Hepatitis Day on July 28. However, in a status report presented to the 9th Hepatitis C Control Measures Promotion Committee in February 2013, it was noted that only 12 out of 139 cities and prefectures with health centers had introduced mobile screening centers.7 Moreover, only 1,014 out of 1,648 local governments had plans to provide individualized hepatitis virus screening recommendations to individuals slated to undergo annual health checkups.7 Further, 13 of the 47 prefectural governments still had not adopted formal hepatitis control policies.

Recommendations • For a certain period (such as five years), screening should be offered to everyone aged 40 and over as part of the annual health checkups that most Japanese people receive, while ensuring that personal information is protected.

• Ideally, the National Health Insurance Act should be revised to include hepatitis screening in the standard special health screening received by people aged 40 and over. At a minimum, the MHLW should recommend more strongly that hepatitis screening be included in all health checkups.

• The 13 prefectures that still have not adopted formal hepatitis control policies should develop and adopt them as soon as possible.

• Based on the Basic Act on Hepatitis Measures, local government hepatitis control measures should be implemented consistently prefecture- and municipality-wide. In particular, hepatitis education for public health officials should be made a priority, so that they can recommend appropriate treatment.

Case Study: National Hepatitis C Strategy in the United States The U.S. policy regarding the hepatitis virus has been the subject of much debate and has seen significant progress since 2010. According to the Centers for Disease Control, up to 5.3 million people—2 percent of the population—are living with chronic hepatitis B or hepatitis C in the United States, where hepatitis is more common than HIV/AIDS, and more Americans have died from hepatitis than from HIV/AIDS.8 Yet, because hepatitis 122 | Lengthening Healthy Lifespans to Boost Economic Growth

May 2013

B and hepatitis C often present no symptoms, most people who have them are unaware until they develop liver cancer or liver disease many years later. In 2010, the publication of Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C by the Institute of Medicine led to the House Committee on Oversight and Government Reform holding a hearing titled, â&#x20AC;&#x153;Viral Hepatitis: The Silent Epidemic,â&#x20AC;? and to a U.S. Congress request for a Viral Hepatitis Professional Judgment Budget to assess what policy and programs are needed.9 In 2011, the U.S. Department of Health and Human Services followed up by issuing a national Action Plan for the Prevention, Care and Treatment of Viral Hepatitis, which called for increased education of health providers and communities, stronger surveillance, and improvements in testing, care, and treatment to prevent liver disease and cancer.10 Finally in 2012, a national Know More Hepatitis education campaign was launched by the White House, in combination with an official U.S. Centers for Disease Control recommendation that all baby boomers (people born between 1945 and 1965) be tested for the hepatitis C virus.11

References

1. National Cancer Center, Center for Cancer Control and Information Services. http://ganjoho.jp/public/cancer/liver/index.htm.

2. Ministry of Health, Labour and Welfare. 2010. Excerpt from reference material number eight, distributed at first session of Hepatitis Strategy Promotion Council.

3. Ibid. Excerpt from reference material number four.

4. Ibid. Annual reports. Op. cit. reference material number eight.

5. Ministry of Health, Labour and Welfare. National survey on getting-tested status of hepatitis screening conducted from December 2010 to January 2011. Results announced August 2012. www.mhlw.go.jp/stf/houdou/2r9852000002gd4j.html.

6. Ministry of Health, Labour and Welfare. 2011. Basic guideline to counter hepatitis (May 16). www.mhlw.go.jp/bunya/kenkou/kekkaku-kansenshou09/pdf/hourei-17.pdf.

7. Ninth Hepatitis Policy Promotion Council. 2011. Materials no. (February 2). www.mhlw.go.jp/stf/shingi/2r9852000002uhts-att/2r9852000002uhz4.pdf.

8. Centers for Disease Control. 2012. The ABCs of hepatitis fact sheet (August). www.cdc.gov/hepatitis/Resources/Professionals/PDFs/ABCTable.pdf.

9. Institute of Medicine. 2010. Hepatitis and liver cancer: A national strategy for prevention and control of hepatitis B and C, consensus report (January). www.iom.edu/Reports/2010/Hepatitis-and-LiverCancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx.

10. U.S. Department of Health and Human Services. 2011. Combating the silent epidemic of viral hepatitis: Action plan for the prevention, care and treatment of viral hepatitis, report (May). www.hhs.gov/ash/initiatives/hepatitis/actionplan_viralhepatitis2011.pdf.

11. CDC Know More Hepatitis campaign. www.cdc.gov/knowmorehepatitis/index.htm and

CDC. 2012. Hepatitis C: Expansion of testing recommendations, fact sheet (August). www.cdc.gov/nchhstp/newsroom/docs/2012/HCV-TestingRecsFactSheet_508.pdf.

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26. Liver Cancer Kills >30,000 People Every Year, >80% of Deaths Are Due to Hepatitis lď Źâ&#x20AC;Ż MHLW indicates1.9â&#x20AC;&#x201C;2.3 million people are infected with hepatitis C virus and 1.1â&#x20AC;&#x201C;1.4 million with hepatitis B virus* lď Źâ&#x20AC;Ż Yet most people infected with viral hepatitis have no symptoms and are unaware until they develop liver cancer or liver disease many years later Cause of Deaths Due to Liver Cancer

;c{+ 9r 8]]]]]]]]]]]]]]]]]]]]+ Others about 17%

Deaths Due to Liver Cancer

Female

Male

HCB about 15%

HCV about 68%

Source: The 18th Follow-up Survey on Primary Liver Cancer in 2005.

Source: MHLW Population Survey Report.

* MHLW Home page http://www.mhlw.go.jp/bunya/kenkou/kekkaku-kansenshou09/hepatitis_about.html

26. Hepatitis Control Measures Should Be Fully Implemented by All Local Governments Progress in Local Government Measures Based on Basic Guidelines for National Hepatitis Control

Status of 47 Prefectures Created plan only focused on hepatitis control ]13 Created plan as part of public healthcare or cancer measures 21 Plan or under consideration 13

Policy of Local Governments (As of January, 2013)

Number with Plans

Creation, distribution of treatment record books to patients/ infected people

23 out of 47 prefectures

Hepatitis training for public health officers of local governments to train them as coordinators for hepatitis treatment support

25]out of 47 prefectures

Implement mobile screening centers under the special infection screening program

12 out of 139]prefectures and major cities

Hepatitis screening recommended individually for people aged 40, 45, 50, 55, 60, and 65

1,014 out of 1,648 local governments

Source: 9th MHLW Hepatitis Strategy Promotion Council on Feb. 1, 2013.

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26. Important to Increase Treatment Rate of Infected Persons l Even if people know they are infected, it is estimated that less than 60% visit a hospital and 50% continue therapy l Of an estimated 1.9–2.3 million people infected with the hepatitis C virus, only 20% receive treatment Number of Patients Who Visit Hospitals for Treatment 1.9 - 2.3 Million

Estimated number of patient with HCV infection Patients with chronic hepatitis or liver disease

370

Thousand

Untreated

Source: MHLW patient survey 2008.

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26. Policy Recommendations Raise Hepatitis Virus Screening Rate

l For a certain period of time (such as five years), screening should be offered to everyone aged 40 and over as part of the annual health checkups that most Japanese people already receive, while protecting personal information. l Ideally, the National Health Insurance Act should be revised so that hepatitis screening is included as part of the standard Special Health Screening received by people aged 40 and over. At a minimum, the MHLW should strengthen its recommendation for hepatitis screening to be included as part of all health checkups.

Raise the Treatment Rate

l The 13 prefectures that still have not adopted formal hepatitis control policies should develop and adopt them as soon as possible. l Based on the Basic Act on Hepatitis Measures, hepatitis control measures should be consistently implemented by prefectural and municipal governments nationwide. In particular, hepatitis education for public health officials should be made a priority, so that they can recommend appropriate treatment.

26. U.S. Case Study: “Know More Hepatitis” National Education Campaign May 2012:

May is National Hepatitis Awareness Month; May 19 is National Hepatitis Testing Day July 2012: Official U.S. government awareness promotion campaign announced at the White House August 2012: Promotion of new CDC recommendation for all baby boomers (persons born between 1945 and 1965) to be tested for hepatitis C

Sources: http://www.cdc.gov/knowmorehepatitis/index.htm, http://www.cdc.gov/nchhstp/newsroom/docs/2012/HCV-TestingRecsFactSheet_508.pdf.

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27. Reduce the Spread of Tuberculosis

Situation One third of the worldâ&#x20AC;&#x2122;s population is thought to be infected with Mycobacterium tuberculosis, and new infections occur at the rate of about one per second.1, 2 Worldwide, the proportion of people who become sick with tuberculosis (TB) each year is stable or falling, but because of population growth, the absolute number of new cases is still increasing.1 In 2007, there were an estimated 13.7 million chronic active cases, 9.3 million new cases, and 1.8 million deaths, mostly in developing countries.3 In addition, it is more likely that people in the developed world who contract tuberculosis do so because their immune systems have been compromised due to higher exposure to immunosuppressive drugs, substance abuse, or acquired immunodeficiency syndrome (AIDS). The distribution of TB is not uniform across the globe. About 80 percent of the population in many Asian and African countries test positive in tuberculin tests, while only 5â&#x20AC;&#x201C;10 percent of the U.S. population test positive.4 In 2007, the country with the highest estimated incidence of TB was Swaziland, with 1,200 cases per 100,000 people. India had the largest total incidence, with an estimated two million new cases.2, 3 In developed countries, tuberculosis is less common and is mainly an urban disease. In the U.K., the national average was 15 per 100,000 in 2007, and the highest incidence rate in Western Europe was 30 per 100,000 in Portugal and Spain. These rates compared with 98 per 100,000 in China and 48 per 100,000 in Brazil.

In the United States, the overall tuberculosis case rate was four per 100,000 persons in 2007.5, 6 In Canada, tuberculosis outbreaks are still seen in some rural areas.7 TB used to be rampant in Japan; however, the number of persons with TB was significantly reduced after World War II, due to the national commitment to implement such countermeasures as the enforcement of the Tuberculosis Prevention Act. However, the awareness of TB among the general public, as well as among medical professionals, has been decreasing in recent years. In fact, the decreasing trend in the number of new cases of TB decelerated after the 1980s. As a result, approximately 23,000 patients are newly diagnosed with TB every year in Japan. Japan remains a country with a moderate risk for TB infection, having higher rates of morbidity and mortality than other developed countries. For example, Japan has an infection rate 4.5 times that of Canada, 4.4 times that of the United States, and 3.7 times that of Sweden. With the number of reported TB infections still high, in order to eradicate TB in Japan there is an urgent need for both rapid diagnosis and aggressive treatment.

Current Policy The Tuberculosis Prevention Law was integrated into the Infectious Disease Law in 2006, and the new law was enacted in 2007. Under the new law, TB is classified as a Category II disease, and all cases must be reported immediately. In the diagnosis of TB, rapid reporting of test results is necessary. Based on the advice of the U.S. Centers for Disease Control and Prevention (CDC), a new TB diagnosis guideline was completed in 2007 by the Japanese Society for Tuberculosis. According to this guideline, liquid testing media are recommended to meet the need for rapid reporting. However, under the Japanese medical system, use of liquid media is not mandated. The lack of rapid and accurate TB diagnoses leads to an unacceptable burden on patients and a waste of precious healthcare resources. Rapid and accurate diagnosis is at the core of the international effort to halt the spread of TB.

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Recommendations Encourage rapid diagnosis to prevent the spread of TB by: • Mandating the use of liquid testing media under the existing Japanese Society for Tuberculosis diagnosis guideline, in order to enhance the speed and accuracy of TB diagnosis in Japan.

• Cultivating initial culture samples on liquid media—which are more rapid and sensitive than other media and have a higher detection rate—in order to reduce the rate of delayed diagnosis and treatment and ultimately to help reduce the length of hospitalization.

References

1. World Health Organization. 2010. Tuberculosis fact sheet. No. 104 (November). www.who.int/mediacentre/factsheets/fs104/en/index.html.

2. Jasmer, R.M., Nahid, P., Hopewell, P.C. 2002. Clinical practice. Latent tuberculosis infection. N Engl J Med 347(23): 1860–6. doi:10.1056/NEJMcp021045. PMID 12466511. http://jasoncartermd.com/resources/pdf/Latent percent20TB percent20Infection.pdf., which cites Dolin, P.J., Raviglione, M.C., Kochi, A. 1994. Global tuberculosis incidence and mortality during 1990– 2000. Bull World Health Organ 72(2):213–20 PMC 2486541, PMID 8205640.

3. World Health Organization. 2009. Global tuberculosis control: epidemiology, strategy, financing.

Epidemiology pp. 6–33. ISBN 9789241563802. http://who.int/entity/tb/publications/global_report/2009/pdf/chapter1.pdf.

4. Kumar, V., Abbas, A.K., Fausto, N., Mitchell, R.N. 2007. Robbins Basic Pathology (8th ed.). Saunders Elsevier. pp. 516–522. ISBN 978-1-4160-2973-1.

5. Konstantinos, A. 2010. Testing for tuberculosis. Australian Prescriber 33(1):12–18. www.australianprescriber.com/magazine/33/1/12/18/.

6. World Health Organization. 2009. Op. cit. pp. 187–300. http://who.int/tb/publications/global_report/2009/annex_3/en/index.html.

7. Rural outbreaks of mycobacterium tuberculosis in a Canadian province. 1998. Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother 38: 555. Abstract no. L-27. http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102188560.html.

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27. Japan TB Infection Rates Remain High Japan is Still a Country with Moderate Risk of Tuberculosis

High

Moderate

Low

SourceÂ&#x2018;2011 Research Institute of Tuberculosis/JATA

Incidence rate per 100,000

27. Current Situation of TB in Japan

Reported Incidence Rateâ&#x20AC;&#x201C; Japan vs. Other Countries

down after the 1980s.

May 2013

USA

) $ Canada ,.

Sweden

( %

Germany /

$ 0 " Netherlands '. "

0 Austria & /

*

â&#x20AC;˘â&#x20AC;Ż The rate of decrease slowed

Denmark

-/ UK " France #.

& / Italy + 0 !

Japan

â&#x20AC;˘â&#x20AC;Ż In Japan, 23,000 new patients are

reported annuallyâ&#x20AC;&#x201D;more than in other developed countries.

Lengthening Healthy Lifespans to Boost Economic Growth | 129

27. Usefulness of Liquid Media

• Liquid media are recommended in the initial culture, where the detection rate is superior in rapidity and sensitivity.

• Liquid media are recommended due to the possibility of shortening expensive hospital stays.

Solid Solid Liquid

# of days

• Current liquid media detection technology is 10 to 14 days faster than solid media.

Number of days required to detect smear (+) vs. smear (-)

Liquid

Smear (+)

Smear (-)

Source: Examination Guideline on Mycobacterium Tuberculosis, 2007 (edited by the Japanese Society for Tuberculosis, Exploratory Committee for Acid-Fast Bacillus Examination Method, 2007). Acid-fast Bacillus Examination Inspected by BACTEC MGIT960 (Kayako Shimizu, 2001).

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28. Establish an HIV Examination System in General Medical Institutions

Situation The number of HIV carriers in Japan is steadily increasing. The total number of new HIV carriers has exceeded 1,000 per year since 2004, and reached 1,503 in 2010. The proportion of patients with the sudden onset of AIDS, discovered after HIV infection has already progressed to AIDS, remains at about 30 percent of new HIV carriers and shows no sign of declining. This is considered to be attributable to the failure of patients to undergo testing for early discovery. The incidence of sudden AIDS is higher in areas where both healthcare professionals and examination subjects are poorly informed and are less cautious concerning HIV infection.

For persons who are aware of the infection risk and strive to undergo HIV testing voluntarily, a network has been established nationwide to offer free/anonymous examinations conducted at public health centers. In recent years, however, the number of persons undergoing such examinations has been in decline. This calls into question the effectiveness of the examination system itself and the methods for encouraging its use.

Although some new HIV carriers have been detected through the free/anonymous examinations conducted at public health centers, these new carriers are more frequently discovered through close investigation of disease and testing conducted as part of nosocomial infection measures at general medical institutions. According to a survey of social medical care, however, HIV antibody tests are included in only around 10 percent of examinations using the HBs antigen and the serologic test for syphilis (STS). It is assumed that 70 percent of HIV carriers in Japan go about their lives unaware of their infection. Determining how to discover infected people who are themselves unaware of their infection is a key to inhibiting the spread of HIV infection. Although HIV infection has become a disease that can be controlled as a chronic disorder, provided appropriate treatment is administered at an early stage, the prognosis for patients with sudden AIDS remains poor. Early identification of HIV carriers contributes significantly to preventing the spread of HIV and boosting the quality of life of carriers. Steps must be taken to widen the base for testing, identifying, and treating people who have been unaware of their infection risk.

Current Policy To date, free and anonymous HIV examinations have been conducted at public health centers and testing rooms within medical institutions as part of a testing/consulting system with user convenience in mind. However, the total number of new patients with HIV discovered at such public health centers represents only 30 percent of all new patients. Between fiscal years 2006 and 2010, the “Strategic Study for the Prevention of AIDS,” based on a Health and Labour Sciences Research Grant (project for AIDS-related issues) strove to double the number of HIV examination applicants, and reduce the number of patients with AIDS by 25 percent over a five-year period (ending at the close of 2010). However, these goals were not achieved. This case shows the limits of a policy that is dependent on the voluntary action of people who are not aware of their risk of infection and who must voluntarily undergo examinations. It also shows that healthcare professionals or other people need to help promote awareness among people at risk and persuade them to take HIV examinations.

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Recommendations • Promote HIV examinations and enhance the examination system so that people become aware that they are at risk and take an HIV examination.

• Lower barriers for HIV testing at general medical institutions and make HIV examinations more accepted, so that the infection of persons who would never otherwise consider their own potential to be infected can be discovered early.

• Introduce a system to test for HIV those patients with an unidentified fever (a significant feature of HIV infection) or who have an STI (closely related to HIV infection).

• Educate general healthcare professionals about the sudden onset of AIDS and the early diagnosis of AIDS. • Concurrent with the path to diagnosis of HIV infection, verify the patient’s past medical history, since those with a medical history of STI are more likely to have HIV and testing should be covered by health insurance.

• For early discovery of those who have never considered their own potential for infection, establish a system of compulsory HIV screening for all in certain age groups (except those who opt out) as in the United States, and as a service covered by health insurance in regions with high infection rates (urban areas) and where the rate is increasing rapidly.

• Ensure that healthcare professionals know the procedures for the consent, handling of results, and counseling of patients with HIV, to avoid HIV infection being perceived as special and to ensure it is handled like other nosocomial infections (HBsAg, HCV antibody, syphilis tests) by revising the Kenikan Notification No. 78 so that HIV examinations can be done in a similar manner to other checks in terms of consent and handling of results.1

Reference 1.

Ministry of Health, Labour and Welfare, Health Service Bureau, AIDS, Tuberculosis and Infectious Disease Control Division. 1993. Notice issued July 13.

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28. Japan Is the Only Developed Country with a Steady Increase in HIV Patients New HIV Infections

HIV Patients •

Current testing insufficient

• System needs consolidation so people get the right tests • Consolidation should be national (not local) policy

l HIV carriers increasing in Japan, with more than 1,000 new carriers per year since 2004, and 1,503 new carriers in 2010. l About 30% of new carriers have sudden symptoms after the onset of AIDS, with no decline in sight.

28. HIV Testing Is Insufficient Increase in HIV Testing

Only 1% increase in number of tests December 2010: 4,986m tests

June 2011: 5,020m tests

l There is a nationwide network for persons aware of the risk of infection and wanting free, anonymous testing at public health centers. l But the current system is not achieving early-detection goals because the number of persons being tested is declining.

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28. HIV Testing System Has Been Set Up in General Medical Institutions l Free, anonymous HIV testing is available at public health centers. But only 30% of those newly diagnosed with HIV were tested at these centers. l The government failed to double the number of persons tested for HIV and reduce the number of AIDS patients by 25% over five years (by the end of 2010). l It must be made easier to receive and provide HIV testing at general medical institutions to increase the screening rate.

28. Recommendations for HIV Testing System at General Medical Institutions l Increase awareness about early diagnosis among general healthcare professionals. l For early discovery among those not aware they may be at risk of infection, set up a system of compulsory HIV screening for all except those who opt out based on age, region, and other criteria. l HIV infections should not be considered special among healthcare professionals, and should be handled like other nosocomial infections (HBsAg, HCV antibody, and syphilis tests), so government HIV notices should be reviewed and reissued.

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29. Reduce the Spread of Sexually Transmitted Infections

Situation The incidence of sexually transmitted infections (STIs) remains high in most of the world, despite diagnostic and therapeutic advances that can rapidly render patients with many STIs noninfectious and cure most STIs. In many cultures, changing sexual morals and use of oral contraceptives have eliminated traditional sexual restraints, especially for women, and both physicians and patients have difficulty dealing openly and candidly with sexual issues. Additionally, the development and spread of drug-resistant bacteria (e.g., penicillin-resistant gonococci) is making some STIs harder to cure.

In 1996, the World Health Organization estimated that more than one million people were being infected daily. About 60 percent of the infections occur in young people under 25 years of age and, of these, 30 percent are under 20 years old. Between the ages of 14 and 19, STIs occur more frequently in girls than boys by a ratio of nearly two to one, although the ratio equalizes by age 20. An estimated 340 million new cases of syphilis, gonorrhoea, Chlamydia, and trichomoniasis occurred throughout the world in 1999 alone.1 The commonly reported prevalence of STIs among sexually active adolescent girls, both with and without lower genital tract symptoms, include Chlamydia (10–25 percent), gonorrhoea (3–18 percent), syphilis (0–3 percent), trichomoniasis, (8–16 percent), and herpes simplex virus infection (2–12 percent). Among adolescent boys with no symptoms of urethritis, isolation rates include Chlamydia (9–11 percent) and gonorrhoea (2–3 percent). A study by the U.S. Centers for Disease Control and Prevention (CDC) found that at least one in four U.S. teenage girls has a sexually transmitted disease.2, 3 Among girls who disclosed they had had sex at least once, the rate was 40 percent.4 Among STIs, the reported number of genital Chlamydia infections in Japan is extremely high, especially among young men and women.5 In many cases, Chlamydia is asymptomatic. Of Japanese high school girls who have participated in sexual intercourse, 13 percent have asymptomatic Chlamydia.6 Untreated Chlamydia in women can cause pelvic peritonitis in 20–40 percent of cases. It also can lead to infertility or ectopic pregnancy in a woman who becomes pregnant. Some women with untreated Chlamydia may have difficulty becoming pregnant.7, 8, 9, 10 Chlamydia is associated with a five-fold risk for contracting the human immunodeficiency virus (HIV) and a five-fold risk for human papillomavirus (HPV) infection, which can cause cervical cancer.11 Furthermore, Chlamydia infection during pregnancy can cause chorioamnionitis, premature delivery and abortion, as well as Chlamydia pneumonia and Chlamydia conjunctivitis in the newborn through fetomaternal infection.12, 13, 14, 15 By detecting Chlamydia infections at an early stage, treatment is possible with regular antibiotics. Delay in detection, however, can lengthen the course of treatment and raise the cost. Women who have been infected with Chlamydia for a long time may require expensive fertility treatment to conceive. This can entail a high cost for the patient or for those local governments that subsidize these treatments. Women of child-bearing age should receive regular Chlamydia screening. It is important to note that Chlamydia remains contagious as long as it remains untreated. It has been reported that the total cost resulting from Chlamydia can be reduced by conducting annual screening tests for women between the ages of 15 and 29.15 An additional outcome of screening may be an increase in the extremely low birth rate in Japan.

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The CDC recommends annual Chlamydia screening for women under the age of 25, and for those women over 25 who have recently changed sexual partners. In addition to the annual Chlamydia screening as recommended by the CDC, the screening is advised by many other organizations, including the American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists (ACOG), American College of Preventive Medicine (ACPM), Canadian Task Force on Preventive Health Care, European Centre for Disease Prevention and Control (ECDC), and the Health Technology Assessment Programme in the U.K. Based on these recommendations, free screening tests are provided in many countries, including the United States, the U.K., Sweden, and Australia.

Current Policy In Japan, many local governments provide free Chlamydia tests. However, the percentage of people who take the tests remains very low. In addition, the tests are conducted using blood samples, making it difficult to judge whether a positive result shows a past infection or a current infection. Additionally, the blood screening test suffers from low sensitivity and false negative results.

Recommendations • Subsidize Chlamydia screening tests for women of childbearing age (roughly 20–35 years of age). In order to realize a high rate of testing and to reduce the cost burden to women, conduct Chlamydia screening at the same time as screening for cervical cancer for women in their twenties and thirties.

• Use a test based on nucleic acid amplification technology, instead of blood screening for the antibody.

• Detect Chlamydia and start treatment at an early stage to increase quality of life for women and reduce the total cost to the public health insurance system of infertility treatment.

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References

1. STD statistics worldwide. Avert.org www.avert.org/stdstatisticsworldwide.htm.

2. Science Daily. 2008. One in four teenage girls in United States has sexually transmitted disease, CDC Study shows (March 12).

3. The New York Times. 2008. Sex infections found in quarter of teenage girls (March 12).

4. The Oklahoma. 2008. CDC study says at least 1 in 4 teen girls has a sexually transmitted disease; HPV most common (March 11).

5. Okabe, N., Tada, Y. 2008. STD trend in Japan suggested by the investigation of infectious disease trends, and the study of the promotion of specific infectious diseases prevention guidelines, pp. 29–43.

6. Obstetrics and gynecology medicine guidelines. 2011. Gynecology outpatients (chapter).

7. Kohl, K.S., Markowitz, L.E., Koumans, E.H. 2003. Developments in the screening for chlamydia trachomatis: a review. Obstet Gynecol Clin North Am 30:637–658.

8. Eschenbach, D. Acute pelvic inflammatory disease. 2008. Glob Libr Women’s Med (ISSN: 1756– 2228) doi 10.3843/GLOWM 10029.

9. Weström, L., Joesoef, R., Reynolds, G., Hagdu, A., Thompson, S.E. 1992. Pelvic inflammatory disease and fertility: a cohort study of 1,844 women with laparoscopically verified disease and 657 control women with normal laparoscopic results. Sex Transm Dis 19:185–192.

10. Røttingen, J.A., Cameron, D.W., Garnett, G.P. 2001. A systematic review of the epidemiologic interactions between classic sexually transmitted diseases and HIV. Sex Transm Dis 28:579–597.

11. Campbell, K.P., Lentine, D. 2006. Sexually transmitted infections (STIs) evidence-statement: screening and counseling. In Campbell, K.P., Lanza, A., Dixon, R., Chattopadhyay, S., Molinari, N., Finch, R.A., eds. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage.

Washington, DC: National Business Group on Health.

12. Di Bartolomeo, S., Mirta, D.H., Janer, M., Fermepin, M.R., Sauka, D., Magarinos, F., de Torres, R.A. 2001. Incidence of chlamydia trachomatis and other potential pathogens in neonatal conjunctivitis.

Int J Infect Dis 5:139–143.

13. Frommell, G.T., Rothenberg, R., Wang, S.P., McIntosh, K. 1979. Chlamydial infection of mothers and their infants. J Pediatr 95:28–32.

14. Schachter, J., Grossman, M., Sweet, R.L., Holt, J., Jordan, C., Bishop, E. 1986. Prospective study of perinatal transmission of Chlamydia trachomatis. JAMA 255:3374–3377.

15. Hu, D., Hook, E.W., Goldie, S.J. 2004. Screening for Chlamydia trachomatis in women 15 to 29 years of age: a cost-effectiveness analysis. Ann Intern Med 141:501–513.

May 2013

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29. Why Screen for Chlamydia?

It Is Spreading among Young Japanese

Annual morbidity rate per 100,000

Epidemiological surveillance of genital Chlamydia infectious in Japan

MEN WOMEN Source: Yoshiaki Kumamoto, JJSTI 15:17-45, 2004.

Chlamydia is the most common sexually transmitted disease.

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Introduction to the Importance of Enhanced Safety & Infection Control

Healthcare-associated infections (HAIs) are infections that patients contract in a healthcare facility from bacteria, viruses, and other pathogens that are frequently resistant to antimicrobial treatment. They result in serious clinical, public health, and economic costs, including prolonged hospital stays, long-term disability, preventable deaths, increased antimicrobial resistance, excess financial costs to healthcare systems, and high costs for patients and their families. Annually, they affect hundreds of millions of patients worldwide.1, 2 Fortunately, many HAIs can be prevented when public policy requires and incentivizes healthcare facilities to implement comprehensive infection prevention and control practices.

The World Health Organization (WHO) reports that HAIs affect hundreds of millions of patients worldwide each year, and estimates that their prevalence in hospitals is 5–12 percent in developed countries and 5–19 percent in developing countries.3 Moreover, HAIs result in massive avoidable healthcare costs. In the United States, the overall direct medical costs associated with treating HAIs ranges from $28.4 billion to $33.8 billion each year.4 Similarly, an Organisation for Economic Co-operation and Development (OECD) study of three countries reveals that HAIs added $7–8 billion annually to healthcare costs in the countries surveyed.5 It is important to note that these figures do not account for lost healthcare worker productivity or opportunity costs due to resources being directed away from other healthcare initiatives. Because HAIs often cause significantly longer hospital stays for patients—three to five times as long, according to some studies6, 7—they can lead to additional financial and emotional costs to patients and their families.

HAIs can be controlled with effective policies and appropriate actions. For example, a comprehensive approach in Western Australia that included active surveillance and screening of high-risk patients has been credited with significant reductions in the rates of MRSA HAIs in that region.8 Similarly, in the United States, the Michigan Keystone Project—a partnership between a major hospital association and a university—achieved a 66 percent reduction in catheter-related bloodstream infections in ICUs, saving an estimated 1,500 lives and $200 million in the first 18 months. While hand hygiene was a component of the Michigan program and is an essential element of success, comprehensive programs cannot rely on hand hygiene alone. Worldwide, studies have shown that compliance with hand hygiene policy is poor, often ranging from 20–50 percent.9, 10 Importantly, the Michigan effort focused on driving changes in culture and practice along with incentives for cooperation.11 HAIs are a serious problem for healthcare systems worldwide that must be addressed through comprehensive policies that include the implementation of the essential elements of infection prevention and control, healthcare facility oversight, investment in infrastructure including technology, as well as incentives to drive change. As the WHO concluded in its report, we must “alert policy and decision makers to the fact that healthcare-associated infection represents a hidden and serious burden for systems and patients alike—and that action is now required.”12

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References

1. Allegranzi, B. et al. 2011. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet (Jan 15) 377(9761):228–41 doi:10.1016/ S0140–6736(10)61458–4.

2. Ibid.

3. Ibid.

4. United States Department of Health and Human Services. Healthcare-associated infections. www.hhs.gov/ash/initiatives/hai/index.html (accessed December 13, 2010).

5. World Health Organization (WHO). WHO launches global patient safety challenge; issues guidelines on hand hygiene in health care. www.who.int/mediacentre/news/releases/2005/pr50/en/index.html (accessed January 17, 2011).

6. Pennsylvania Health Care Cost Containment Council. Healthcare-acquired infections in Pennsylvania—2005 key findings. www.phc4.org/reports/hai/05/keyfindings.htm.

7. Vincent, J.L. et al. International study of the prevalence and outcomes of infection in intensive care units.

8. Gilbert, G. et al. 2009. Infection control, ethics and accountability, MJA 190: 696–698.

9. Allegranzi. Op cit.

10. Ibid.

11. Herzer, Kurt. United States Department of Health and Human Services, Office of Health Reform. A success story in American health care: Eliminating infections & saving lives in Michigan. www.healthreform.gov/reports/success/michigan.html.

12. Allegranzi. Op. cit.

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52.6% of General Public in Japan are Concerned About the Risk of Becoming Infected with HAIs Q: How concerned are you about the risk of becoming infected with a disease while at a hospital, clinic, or other healthcare provider either as a patient or healthcare professionals? (%, single answer)

Overall (n=5000)

12.1

Male (n=2401)

40.4

9.6

Female (n=2599)

22.9

38.1

14.4

6.6

22.9

7.7

42.6

20-­‐29 (n=678)

12.2

30-­‐39 (n=863)

12.2

40.1

40-­‐49 (n=800)

12.0

41.0

50-­‐59 (n=779)

11.7

42.1

25.2

60-­‐69 (n=882)

11.5

42.7

23.1

40.0

24.3

70-­‐79 (n=790)

13.5

80+ (n=208)

11.1

6.6

22.8

21.2

20%

\OSlightly concerned

5.5

22.1

35.1

0% \OConcerned

20.4

40%

\ONeither nor

\ODo not know

5.7

12.1

15.9

2.5 7.4

7.3

13.2

7

14

6

5.1 3.3

12.1

3

6

14.1

2.6

5.7

13.4

3

9.6

60%

4

15.9

22.9

37.5

13.9

17.8

5.3

80%

100%

\ONot very concerned

\ONot concerned

Source: Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan (2011) by The American Chamber of Commerce in Japan.

Internet survey conducted October 31–November 2, 2011. 5,000 respondents that represent the Japanese population.

65% of Japanese Say it is Important to Select Hospitals that Take Measures to Prevent HAIs Q: How important is a hospital or clinic’s measures to prevent healthcare associated infections when choosing a facility? (%, single answer) Is Important

Overall (n=5000)

27.9

Male (n=2401)

26.2

Female (n=2599)

37.7 36.9

29.4

20-­‐29 (n=678)

20.4

30-­‐39 (n=863)

20.7

40-­‐49 (n=800)

26.0

39.4 38.3

24.3

40.3

34.1

37.4

70-­‐79 (n=790)

33.5

37.1

38.9 0%

20%

\OImportant \OSlightly important

20.8 20.1 19.9

30.8 40% \ONeither nor

7.8

26.5

60-­‐69 (n=882)

80+ (n=208)

7.4 4.7

22.2

34.8

29.4

6.8 3.8

22.9

38.4

25.0

50-­‐59 (n=779)

22.6

15.9 60%

\ODo not know

65.5% 63.0%

6.2 2.9

67.8%

8.3

55.2%

8.1 3.7

60.1%

6.8 3.8

63.3%

5.9 2.6

69.7%

5.42.4

71.5%

5.7 3

70.6%

10.6 2.9

69.7%

80% \ONot very important

100% \ONot important

Source: Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan (2011) by The American Chamber of Commerce in Japan.

Internet survey conducted October 31–November 2, 2011. 5,000 respondents that represent the Japanese population.

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80% of General Public in Japan Think it is Important for Hospitals to Publicly Disclose Measures to Prevent HAIs Q: Hospitals and clinics implement many measures to prevent healthcare associated infections.

How important is it to disclose these measures to the public? (%, single answer) Is Important

Overall (n=5000)

44.2

Male (n=2401)

43.0

Female (n=2599)

35.7 34.2

45.4

20-­‐29 (n=678)

36.3

30-­‐39 (n=863)

36.3

40-­‐49 (n=800)

16.2

39.3

47.9

60-­‐69 (n=882)

50.7

70-­‐79 (n=790)

49.0

80+ (n=208) 0%

20%

33.8

75.6%

6.4

79.6%

4.6

84.2%

9.0 3.9

85.8%

10.3 5.2

26.4

\ONeither nor

7.1

9.6

35.1

40%

\OImportant \OSlightly important

11.4

11.1

60%

82.8% 76.0%

10.6

80%

\ODo not know

82.5% 71.4%

7.2

36.3

49.5

5.2

15.4

36.8

77.2%

6.6

10.9

35.1

80.0%

5.9

12.9

37.1

42.9

50-­‐59 (n=779)

11.8

100%

\ONot very important

\ONot important

Source: Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan (2011) by The American Chamber of Commerce in Japan.

Internet survey conducted October 31–November 2, 2011. 5,000 respondents that represent the Japanese population.

75.7% of General Public in Japan Think it is Important to Have a National Program to Reduce the Risk of HAIs Q: How important do you think it is for the government to have a national program to reduce the risk of infections associated with hospitals, clinics or other healthcare facilities? (%, single answer)

Overall (n=5000)

40.5

35.2

Male (n=2401)

40.2

34.4

Female (n=2599)

40.8

20-­‐29 (n=678)

18.6

39.2

37.3

50-­‐59 (n=779)

14.4

38.1

31.4

40-­‐49 (n=800)

14.2

35.9

29.4

30-­‐39 (n=863)

14.3

36.4

43.0

15.9

36.2

60-­‐69 (n=882)

48.5

32.9

70-­‐79 (n=790)

48.9

30.6

80+ (n=208)

52.4 0%

12.1 11.2 12.9

27.4

20%

40%

\OImportant \OSlightly important

\ONeither nor

60% \ODo not know

6.8 2.1

75.7%

7.2 2.2

74.6%

6.3 2

76.6% 67.4%

7.4 6.6

17.6

7.7

Is Important

7.9 2.5

70.6%

7.4 1.8

73.6%

5.92.1

79.2%

5.61.2

81.4%

5.61.4

79.5%

10.6 1.9

80% \ONot very important

79.8%

100% \ONot important

Source: Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan (2011) by The American Chamber of Commerce in Japan.

Internet survey conducted October 31–November 2, 2011. 5,000 respondents that represent the Japanese population.

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3% of Japan Have Contracted an HAI 11.5% Know Someone Who Has Contracted an HAI Q: Have you ever become infected with a disease while at the hospital/clinic or other healthcare facili:es, either as a pa:ent or a healthcare professional?

1.9

Q: Do you know anyone who has become infected with a disease while at the hospital, clinic, or other healthcare facili:es either as a pa:ent or healthcare professional?

7.0

(N=5,000, %)

12.0 4.5

11.0 1.0

77.2

86.2

\OAware of someone who was infected as a pa(ent \OAware of someone who was infected as a healthcare professional \ODo not know anyone who was infected \ONot sure

\OYes, as a pa(ent \OYes, as a healthcare professional \ONo, never \ONot sure

Source: Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan (2011) by The American Chamber of Commerce in Japan.

Internet survey conducted October 31– November 2, 2011; 5,000 respondents from Rakuten Research’s registry that represent the Japanese population.

5.7% of Japanese Take Steps to Control HAI; 45.3% Would Like to Learn More Q: Do you know what you can do as a pa:ent or visitor to reduce healthcare associated infec:ons?

(N=5,000, %, single answer)

19.6

5.7

14.9

2.9 11.5

17.6 27.7

\OI know and perform several \OI know several but do not fully perform them \OI do not know how, but would like to learn and perform them \OI do not know how, but would like to learn

\OI am not very interested \OI am not interested at all \ODo not know

Source: Survey on Prevention, Early Detection and the Economic Burden of Disease in Japan (2011) by The American Chamber of Commerce in Japan.

Internet survey conducted October 31– November 2, 2011; 5,000 respondents from Rakuten Research’s registry that represent the Japanese population.

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30. Enhance Prevention of Healthcare-associated Infections

Situation A healthcare-associated infection (HAI), also known as a nosocomial infection, is an infection that a patient contracts while receiving treatment for another condition in a healthcare facility.1 Patients who are hospitalized, especially patients in critical care units, are constantly at risk of developing nosocomial infections. Patients who incur these infections are hospitalized longer as a result of the infection, and require treatment, leading to higher overall costs for hospitals and payers.2, 3 A recent study of stroke patients in 36 Japanese hospitals showed a HAI incidence rate of 16.4 percent. Patients who contracted HAIs paid on average the equivalent of an additional $3,067 in medical fees and remained hospitalized for an additional 16.3 days.4 HAIs are preventable. A study evaluating 30 reports on HAIs concluded that “great potential exists to decrease nosocomial infection rates, from a minimum reduction effect of 10 percent to a maximum reduction effect of 70 percent”.5 It is well documented that the adoption and implementation of infection control guidelines and programs by hospitals reduces the HAI infection rate, thereby reducing the attributed length of stay and associated costs.6 According to the Agency for Healthcare Research and Quality (AHRQ), a research agency within the U.S. Department of Health and Human Services (HHS), “serious HAIs that lead to extended hospital stays, and ultimately increased cost and risk of mortality, include bloodstream infections (BSIs), catheter-associated urinary tract infections (CAUTIs), surgical site infections (SSIs), and ventilator-associated pneumonia (VAP). These four infections account for more than 80 percent of all HAIs.”7 Many of these infections are resistant to treatment with antibiotics, leading to serious illnesses, debilitating post-treatment effects, and in some cases death. Some bacteria that cause HAIs can survive in the healthcare environment, including on medical devices, surgical tools, unwashed hands, and the clothing of hospital personnel, and are easily transmitted from patient to patient when healthcare professionals do not observe good infection control practices.

Active surveillance and “bundled” infection control practices are the solution for preventing HAIs. By knowing in advance that a patient is a carrier of an infectious pathogen, healthcare workers and facilities are better able to take appropriate actions to control and prevent the spread of infection. Special infection prevention programs, such as decontamination before surgery, can help protect patients. Active surveillance is most effective when all hospital in-patients are screened at the time of admission.

Active surveillance is most important for patients in intensive care units and emergency rooms and for all high-risk patients, such as those who are immunocompromised or undergoing long-term hospitalization. Active surveillance is not intended to serve as a substitute for the diagnosis of infection. Rather, active surveillance has been found to be an effective tool that healthcare facilities can use for the detection and control of infectious pathogens such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), the human immunodeficiency virus (HIV), and hepatitis viruses.

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institutions in Japan to take measures to secure safety in operation with regard to HAIs. The enforcement ordinance for this amendment includes four core mandates: 1. Execute hospital infection prevention guidelines.

2. Hold hospital infection prevention committee meetings.

3. Implement infection prevention training for employees.

4. Report infectious disease incidence status.

Healthcare institutions not implementing these infection prevention methods may be inspected. In addition, the Ministry of Health, Labour and Welfare (MHLW) Ministerial Ordinance Official Notice for Infection Prevention in Healthcare Facilities was issued on June 17, 2011. The notice contains guidance regarding the following: 1. Establishing an infection control team and its role.

2. Collaboration between institutions for cases that individual institutions cannot handle, including outbreaks caused by multidrug-resistant bacteria.

3. Criteria on suspected outbreaks and requirements for reporting to health centers.

4. However, the problem remains that, should there be an outbreak of infection at a noncompliant hospital, there is no penalty other than a reprimand for not upholding social responsibility. Stronger infectious disease control mandates are needed.

In the 2012 medical fee revision, the hospital fee for infection control efforts was considerably raised. Although the requirements include activities such as holding regular conferences, they do not include specific activities to recognize the actual status of, and countermeasure for, HAIs. Recent government statements support stronger mandated infection control. The American Chamber of Commerce in Japan (ACCJ) and the European Business Council in Japan (EBC) welcome the statement made on June 21, 2010, by Assistant Minister for Global Health Mr. Masato Mugitani, on behalf of the MHLW, pledging support to address healthcare associated infection.7 One of the objectives of this pledge is “to promote the highest standards of practice and behavior to reduce the risks of healthcare-associated infection.” We commend the measures taken by the MHLW to meet this objective, in particular the steps taken to establish a national infectious disease surveillance system and the instructions to hospitals on infection control reporting.

Recommendations • Develop a comprehensive HAI prevention strategy, including “bundling” of proven infection control practices, education, and cultural change. Such a strategy should consider the impact that enabling technologies, such as rapid molecular diagnostic testing and novel medical devices, have in improving patient safety and reducing HAIs. Information technology should also be utilized to enhance implementation of HAI surveillance and prevention.

• Clearly define reasonable HAI prevention targets for healthcare institutions and measure progress over time. Wherever possible, establish baseline HAI incidence rates, using standardized metrics to allow measurement of hospital-specific progress in achieving prevention targets.

• Provide incentives, including rewards and penalties, to promote compliance with HAI prevention targets. Every healthcare facility should develop and maintain a comprehensive HAI control and reduction plan that is consistent with current standards of care and best practices. Facilities that fail to develop, implement, and maintain a current HAI control and reduction plan should face sanctions until they are compliant.

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•

• •

• •

Coordinate efforts at government and institutional levels with stakeholder support.

Prevention and reduction of HAIs will require a concerted effort by all healthcare institutions, with engagement and leadership from policy-setting bodies at different levels of government and with the support of stakeholder organizations.

Provide the Japanese government with adequate resources, in addition to international, local, and institutional efforts. This also includes identifying and prioritizing gaps in HAI research.

Implement active surveillance, early screening, detection, and monitoring in the healthcare setting of infectious pathogens, such as multidrug-resistant organisms and bacteria, as well as the well-known pathogens, MRSA, VRE, Clostridium difficile, HIV, and hepatitis viruses.

Develop reimbursement incentives for facilities that implement active surveillance and periodic environmental monitoring for microbial contaminants such as MRSA. On a broader scale, the ACCJ and the EBC commend the government of Japan’s acknowledgement of the work by the World Health Organization World Alliance for Patient Safety. The ACCJ and EBC recommend optimizing international cooperation to exchange best practices and encourage Japan and all 21 Asia­–Pacific Economic Cooperation (APEC) member economies to support the current effort by the APEC Life Sciences Innovation Forum to fight HAIs through enhanced infection prevention and control region wide.

References

1. U.S. HHS. Agency for Healthcare Research and Quality, www.ahrq.gov/qual/haiflyer.htm.

2. Lee, J., Imanaka, Y., Sekimoto, M., Ikai, H., Otsubo, T. 2011. Healthcare-associated infections in acute ischaemic stroke patients from 36 Japanese hospitals: risk-adjusted economic and clinical outcomes. Int J Stroke 6:16–24.

3. Chen, Y., et al. 2009. Incidence rate and variable cost of nosocomial infections in different types of intensive care units, Infect Control Hosp Epidemiol 30:39–46.

4. Lee, J., et al. Op. cit.

5. Harbarth, S. 2003. The preventable proportion of nosocomial infections: an overview of published reports, Journal of hospital infection 54:258–266.

6. Rosenthal, V., et al. 2010. International nosocomial infection control consortium (INICC) report, data summary for 2000–2008 issued June 2009, American Journal of Infection Control 38:95–106.

7. www.who.int/gpsc/statements/countries/cah_japan_pledge_2010_en.pdf.

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30. Healthcare Associated Infections: A Global Healthcare Issue • Nearly 6 million HAIs/annum in U.S., Europe and Japan.

Millions of Infections 8

5.6

6

5.9

6.3

6.4

• 1.7 million cases and 99,000 deaths annually in the U.S.

6.9

4

2

Japan Europe

0

U.S. 2002

2005

2009

2010

2015

• In some developing countries, more than 25% of patients admitted to hospitals acquire HAIs. • Hundreds of millions of patients impacted worldwide each year.

Source: Inhibitex

30. Summary Report: 2008 MRSA HAI Surveillance Medical expense with and without MRSA infection (n =) Ave days in Hosp Medical expense - Patient/day

w/o MRSA 60,558 15.78 51,779

Total medical expense for MRSA infection

1. Total number of in patient per day 2. rate of inpatient become MRSA 3. Total MRSA infection (incident/day) 4. From above, medical expense

w MRSA: 55.843 X 96.07 w/o MRSA: 51,779 X 15.78 5. Difference 5,364,837 - 817,072.6 6. Total = difference X incident/day X 365 day 4,547,764.4 X 160 X 365

w MRSA 167 96.07 55,843

39,953 (2008) 0.4 % 160/day = 5,364,837 = 817,072.6 = 4,547,764.4 = ¥265,589,440,960

Total of more than ¥265 Billion is spent for MRSA HAI. Patient stays more than 80 days longer in Hospital w/HAI. Source: Kobayashi H., et al Journal of Japanese Environmental Infection Vol. 26, No.2, 2011.

Note: Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium that has developed resistance to standard types of antibiotics, which makes infections more difficult to treat and thus more dangerous.

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30. “Bundles” of Best Practices Comprehensive “Bundles” of best practices include: • • • • • •

Screening patients for multi-resistant organisms Hand hygiene Isolation and contact precautions Improved environmental cleaning Antibiotic stewardship Optimal management of safety-engineered vascular access devices

There are various guidelines for preventing HAIs such as: • • • •

SHEA Guideline (2003 CDC/HICPAC Guideline Nov. 2006 Best practice guide for preventing MRSA infection by APIC March 2007 Guidelines for the control and prevention of MRSA in healthcare facilities by HIS, U.K. (2006)

30. Must Improve Japanese System for Preventing HAIs l No HAI prevention strategy l No HAI data l No HAI prevention target l No incentive to prevent HAI

l HAI prevention strategy, including “bundles” of proven infection control practices l Require regular reports as a way to grasp actual situation l Define reasonable HAI prevention targets l Provide incentives, including rewards and penalties, to promote compliance with HAI prevention targets

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31. Improve Infection Control: Closed vs. Open Systems

Situation Many nosocomial infections occur when medication/fluids are administered via an intravascular device.1 A common example of infections caused by exposure to air and contamination via intravenous (IV) systems are bloodstream infections (BSIs). BSIs have a significant influence on patient outcomes because these infections can either be the patient’s primary cause of death, or exacerbate the patient’s primary condition, which could lead to death. A surveillance study by the International Nosocomial Infection Control Consortium (INICC), conducted in intensive care units (ICUs) in Latin America, Asia, Africa, and Europe, demonstrated that the mortality rate of patients with BSIs was 29.6 percent.2 Most bloodstream infections and their associated risks can be prevented. The use of innovative medical products can play an effective role in BSI prevention. For example, closed intravenous systems have a proven record of reducing BSIs, thereby potentially improving patient safety and reducing costs of associated longer hospital stays and treatment. In a closed IV system, the fluid is not exposed to the outside air, which significantly reduces the risk of contamination and infections. Studies have shown that BSI rates were reduced when changing from an open to a closed system. In Mexico, the BSI rate was reduced by more than 80 percent,3 in Argentina by 64 percent,4 in Italy by 61 percent5 and in Brazil by 55 percent.6 The results of a clinical study conducted in Argentina demonstrate that the mortality rate associated with BSIs can be reduced by 91 percent if patients receive fluids via a closed IV system.7 The reduction of BSI rates lowers costs by shortening ICU length of stay and reducing the use of antibiotics and other medications required to treat BSIs. Studies conducted in Mexico and Brazil have shown that reducing BSI rates may lead to significant cost savings.8, 9 Recognition of closed system safety innovation through higher reimbursement would also encourage the use of newer closed system devices over existing older open system devices that sacrifice safety for a lower unit cost.

Current Policy In Japan, the medical fees set for many types of cases do not assume use of closed systems; indeed, there is no distinction between open and closed systems in medical fee reimbursement schedules. As a result, medical institutions must bear the additional associated costs of purchasing and using advanced closed system medical devices.

The pricing rules for Special Treatment Materials also lack incentives for using closed systems: the distinction between open and closed systems is not established in existing reimbursement categories. This results in the pricing of closed system devices that are designed for enhanced safety and infection control being set at the same level as the older, less innovative, and less safe open systems.

Recommendations • The Japanese government should encourage hospitals to make the use of innovative medical products, such as closed intravenous systems, an integral part of hospital infection control policy.

• Revise medical fees to reflect the cost and use of closed system medical devices in both inpatient and outpatient settings.

• To further enhance safety and the practice of infection control, establish a clear distinction between open and closed systems through the creation of new functional categories.

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References

1. Maki, D., et al. 2006. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies, Mayo Clin Proc 81:1159–1171.

2. Rosenthal, V., et al. 2008. International nosocomial infection control consortium (INICC) report, data summary for 2002–2007, American Journal of Infection Control 36:627–637.

3. Frausto, S.R., et al. 2005. Blue Ribbon Abstract Award: Cost effectiveness of switching from an open IV infusion system on rates of central venous catheter-associated bloodstream infection in three Mexican hospitals. Am J Infect Control 33:e54–e55.

4. Rosenthal, V.D., et al. 2004. Am J Infect Control.

5. Franzetti, F., et al. 2009. Effectiveness of switching from open to closed infusion system for reducing central vascular associated bloodstream infections in an Italian hospital. American Journal of Infection Control 35(5):e67-e68.

6. Salomao, R., et al. 2007. Probability of developing a central vascular catheter-associated bloodstream infection when comparing open and closed infusion systems in Brazil. Proceedings and abstracts of the 47th annual scientific meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. Chicago, United States (September 17–20).

7. Rosenthal, V.D., et al. 2004. Am J Infect Control.

8. Higuera, F., et al. 2007. Attributable cost and length of stay for patients with central venous catheter-associated bloodstream infection in Mexico City intensive care units. Inf Control Hosp Epidemiology 28:31–35.

9. Salomao, R., et al. 2006. The attributable cost, and length of hospital stay of patients with central line-associated blood stream infection in intensive care units in Brazil. Am J Infect Control 34:e22.

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31. Closed System in Infusion Line Use of all-in-one system with IV catheter, extension tube, and fixed plate and closed IV system allows reduction of blood stream infections.

Closed system devices

Closed IV catheter system

31. Development of Closed Cap Main line

Piggyback line

(With open three-way stopcock)

Need to release the end cap when connecting -> possibility of bacterial infections

CV Catheter

Main line

Piggyback line

(With closed three-way stopcock) By closing the connectors, infection risk is reduced

CV Catheter

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31. History of Infusion System Devices

Mechanical valve

Cannula access split septum

Split septum

Luer access split septum

Closed system

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32. Skin Antisepsis

Situation According to the Report on the Burden of Endemic Health Care-Associated Infection Worldwide, issued by the World Health Organization (WHO) in May 2011, healthcareassociated infections (HAIs) continue to be the most frequent adverse event in healthcare delivery worldwide.1 The study also reports that, for every 100 of the world’s hospitalized patients, somewhere between seven and 10 will acquire at least one HAI.1 The findings of this WHO report are a reminder that access to care does not necessarily imply safe care.1 HAIs represent a major patient-safety issue worldwide. They are the most frequent adverse events during healthcare delivery and potentially result in prolonged hospital stays, long-term disability, increased antimicrobial resistance, high additional costs for the healthcare system, financial and human-suffering burdens for patients and their families, and excess deaths.1 The WHO report estimates the prevalence for HAIs occurring among patients in developed countries to be 7.6 per 100 patients.1 Estimates of HAIs for developing countries, defined as lower- and middle-income countries, vary widely with two-thirds (66 percent) of 147 developing countries having no published data and only 23 of 147 developing countries (15.6 percent) having an operational national surveillance system for HAIs.2 As of 2010, only a fragmented picture of the endemic burden of HAIs is available from published data for developing countries.2 The prevention and control of infections represent one of the most significant safety initiatives for a healthcare organization. Infections can be acquired in any healthcare setting, transferred between healthcare institutions, or brought in from the community.

Because infections are a significant safety risk for patients and healthcare workers (HCWs), infection prevention and control must be high on every organization’s list of priorities. Hand in hand with robust hand hygiene and environmental disinfection, skin antisepsis is fundamental to the prevention of healthcare-associated infection and is a critical component of an effective infection prevention and control program. While many antiseptics have been used over the years, clorhexidine gluconate (CHG) is increasingly becoming the standard of care for skin antisepsis for the prevention of HAIs on a global basis.

CHG is a broad-spectrum skin antisepsis compound that, when used in appropriate concentrations, has rapid and long-term antiseptic properties. A large and growing base of scientific evidence supports the efficacy of CHG in reducing both gram-positive and gramnegative bacteria. As a result, CHG is increasingly considered the standard of care for skin antisepsis in countries with developed infection control practices. The overwhelming body of clinical evidence supporting the safety and efficacy of CHG has led to growing awareness and adoption globally. CHG is recommended in HAI guidelines in a growing number of countries and is a compulsory component of the patient care “bundles” or interventions for prevention of the most costly and deadly device-related HAIs—catheterrelated bloodstream infections (CRBSIs), surgical site infections (SSIs), and ventilatorassociated pneumonia (VAP). While allergic reactions can occur, according to the WHO, the U.S. Centers for Disease Control and Prevention (CDC) and other influential health organizations, CHG is considered to be both safe and effective. Many key Japanese opinion leaders favor use of CHG to prevent all device-related infections.

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Current Policy In Japan, although there are some guidelines recommending that using 0.5 percent chlorhexidine solution has the same efficacy as a 10 percent povidone iodine or 70 percent alcohol solution for skin antisepsis, there is no specific national guideline to recommend the specific use of applications of more than 0.5 percent chlorhexidine.

Those healthcare practitioners leading infection prevention in Japan recognize the CDC guidelines and are aware of the Institute for Healthcare Improvement (IHI) care bundles, while some health institutions are following these recommended practices. Actual practice is often inconsistent with these recommendations, however, because of the fear of allergy and the perceived relatively high cost of single-dose applicators. To better ensure infection prevention in Japan, evidence-based general skin antisepsis protocols should include, at a minimum, those globally recognized best practices being employed worldwide to reduce and prevent HAIs. Recommendations In line with global best practices, basic skin antisepsis guidelines should include, at a minimum, the following protocols: • Skin antisepsis for the insertion and maintenance (dressing changes) of central venous catheters, peripherally inserted central catheters (PICCs) and peripheral catheters (arterial or venous).

• Preparation of clean skin with a >0.5 percent chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter insertion, and during dressing changes. If there is a contraindication to chlorhexidine, tincture of iodine, an iodophor, or 70 percent alcohol can be used as alternatives.3, 4, 5 • Preparation of clean skin with an antiseptic (70 percent alcohol, tincture of iodine, an iodophor, or CHG) before peripheral venous catheter insertion.3, 4 CHG may be more effective in preserving the IV site, increasing its longevity, decreasing sample (blood) contaminant, and preserving sample integrity.

• Skin antisepsis for patient presurgical bathing and presurgical skin prep.

• Use 2 percent chlorhexidine wash for daily skin cleansing to reduce the chance of SSI.3, 6, 7, 8 • Skin antisepsis for surgical skin prepping (pre-operating room, and can be inclusive of cut-down procedures for the placement of central venous catheters [CVCs], such as tunneled dialysis catheters, and subcutaneous ports).

• Use 2–4 percent chlorhexidine as an antimicrobial agent for surgical skin prepping (not for use on eyes, ears, mucous membranes).9 • Single-dose applicators for skin antisepsis: • They eliminate contamination of multi-use bulk solution bottles • Increases compliance with skin antisepsis guidelines • Reduce the need for skin antisepsis solution, durable materials, and sterile reprocessing • Reduce procedure time • Lower both the direct cost of skin antisepsis practices and indirect costs (labor and time).

Avoidance of bulk solutions for skin antisepsis, due to the risk of contamination. While single-dose applicators are not specifically called for in the CDC guidelines, they have the earlier-mentioned benefits.

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References

1. World Health Organization. 2011. Report on the burden of endemic health care-associated infection worldwide. http://whqlibdoc.who.int/publications/2011/9789241501507_eng.pdf.

2. Allegranzi, B., et al. 2011. Burden of endemic health-care associated infection in developing countries: Systematic review and meta-analysis. Lancet. (Jan 15) 377(9761):228–241.

3. Centers for Disease Control and Prevention. April 1, 2011 Guidelines for the Prevention of Intravascular Catheter-Related Infections. http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011.html.

4. Maki, D.G., Ringer, M., Alvarado, C.J. 1991. Prospective randomized trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters.

Lancet 338:339−43.

5. Mimoz, O., Pieroni, L., Lawrence, C., et al. 1996. Prospective, randomized trial of two antiseptic solutions for prevention of central venous or arterial catheter colonization and infection in intensive care unit patients. Crit Care Med 24:1818−23.

6. Bleasdale, S.C., Trick, W.E., Gonzalez, I.M., Lyles, R.D., Hayden, M.K., Weinstein, R.A. 2007.

Effectiveness of chlorhexidine bathing to reduce catheter associated bloodstream infections in medical intensive care unit patients. Arch Intern Med 167:2073−9.

7. Munoz-Price, L.S., Hota, B., Stemer, A., Weinstein, R.A. 2009. Prevention of bloodstream infections by use of daily chlorhexidine baths for patients at a long-term acute care hospital. Infect Control Hosp Epidemiol 30:1031−5.

8. Popovich, K.J., Hota, B., Hayes, R., Weinstein, R.A., Hayden, M.K. 2009. Effectiveness of routine patient cleansing with chlorhexidine gluconate for infection prevention in the medical intensive care unit. Infect Control Hosp Epidemiol 30:959−63.

9. WHO. Guidelines for safe surgery 2009: Safe surgery saves lives. ISBN 978 92 4 159855 2.

Additional References

a. Resar, R., Griffin, F.A., Haraden, C., Nolan, T.W. 2012. Using care bundles to improve health care quality. IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement. www.IHI.org. b. Anderson, D.J., Kaye, K.S., et al. 2008. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol 29 Suppl 1:S51–61. c. Al-Tawfiq, J.A. and Abed, M.S. 2010. Decreasing ventilator-associated pneumonia in adult intensive care units using the Institute for Healthcare Improvement bundle. Am J Infect Control. d. Flanders, S.A., Collard, H.R., Saint, S. 2006. Nosocomial pneumonia: state of the science. Am J Infect Control 34:84–93. e. Rosenthal, V.D., Guzman, S., Crnich, C. 2006. Impact of an infection control program on rates of ventilator-associated pneumonia in intensive care units in 2 Argentinean hospitals. Am J Infect Control 34:58–63. f. Siempos, I.I., Vardakas, K.Z., Falagas, M.E. 2008. Closed tracheal suction systems for prevention of ventilator-associated pneumonia. Br J Anaesth, 100(3):299–306. g. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. 2005. Am J Respir Crit Care Med 171:388–416. h. Institute for Healthcare Improvement. Sepsis Resuscitation Bundle. www.ihi.org/knowledge/Pages/Changes/ImplementtheSepsisResuscitationBundle.aspx.

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32. Antiseptic Solution Recommended in HAI Guidelines in a Growing Number of Countries • CDC. 2011. Guidelines for the prevention of intravascular catheter-related infections • Prepare clean skin with a >0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter insertion and during dressing changes. If there is a contraindication to chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol can be used as alternatives.

• Use a 2% chlorhexidine wash for daily skin cleansing to reduce CRBSI.

• WHO. Guidelines for safe surgery 2009: Safe surgery saves lives.

• Use of 2–4% chlorhexidine as an antimicrobial agent for surgical skin prepping (not for use on eyes, ears, mucous membranes).

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32. Antiseptic Solutions Currently Used Main antiseptic solutions used by type of procedure, 2012 (% of procedures)

Legend Other (sterile water, soap) Alcohol Iodine CHG 1% CHG <1%

• CHG is becoming more common for catheter-related procedures, while adoption for surgical skin prep appears to be emerging • 1% CHG is new in Japan, KOLs anticipate it will become the next standard Source: Advention BP.

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33. Prevent Bloodstream Infections by Using Appropriate Devices

Situation Potential Factors in Catheter Infection Catheter-associated infections include exit, tunnel, pocket and bloodstream infections.4 In the United States, these kinds of infections extend the length of hospital stays by an average of 12 days and result in an additional cost of some $18,432 per patient. As reported by the U.S. Centers for Disease Control (CDC), some 250,000 bloodstream infections (BSIs) resulting from central vascular catheter (CVCs) have been estimated to occur annually,1 with an estimated death rate of some 12–25 percent (30,000–62,500) as a result of catheter-related bloodstream infections (CRBSIs). The prevention of CRBSIs is important for improving patient outcomes, and depends on having appropriate medical care, product guidelines, and infection control.

Examples of the potential factor related to the catheter infection risk include: 1. The length of time catheters remains inserted.

2. The frequency with which catheters are inserted and removed.

3. The use of multiple-lumen catheters.

4. Immunosuppression.2 Local infection often arises in such areas as the catheter insertion site, or the tunnel for, or pocket of, an implanted port, and can occur concurrently with a BSI. The indications include local oppressive pain, the sensation of heat, sweating, hardened areas, and pus discharge. These can be identified by visual examination and by lightly tapping the dressing over an insertion site, tunnel, or port pocket. Should any abnormality be detected, the dressing should be removed and the site carefully inspected.3 Evaluating Catheter-related BSIs • Regularly check catheter insertion sites.3 • Observe a patient’s general condition (including for fever, chills, sweating, malaise, lassitude, muscular pain, weakening, tachycardia, changes in consciousness, and sharp pain).3 • Pay attention to immunosuppressed patients, because symptoms of infection are not readily apparent.3 • When infection is suspected, promptly start treatment (with blood culture, antibiotics) as instructed by the doctor. It has been estimated that fatalities exceed 50 percent for patients not treated within 24 hours of the onset of infection.3 Reduce CRBSIs with Needleless Systems Use of needleless systems is included in the 2011 CDC guidelines for preventing intravascular catheter-related infections: “a split septum valve may be preferred over a mechanical valve due to increased risk of infection with some mechanical valves.”5 The recommendation was added because the CDC found evidence that the structure of needleless systems affects the incidence of CRBSIs.6 A study provides strong evidence that both positive- and negative-pressure mechanical valves are linked to increases in CRBSIs, in conditions where the CRBSIs, surveillance methods, and infection prevention measure are the same.7 When switching from a split septum to a positive- or negativepressure mechanical valve, an increase in CRBSIs was observed in all ICUs and wards. In addition, switching the valves back to a split septum resulted in a significant decrease in CRBSIs in 14 ICU rooms. When planning the introduction of a closed type IV needleless 158 | Lengthening Healthy Lifespans to Boost Economic Growth

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system, hospital staff should keep an eye on CRBSIs to ascertain whether they result from use of mechanical valves.7 Efficacy of PICCs in Reducing CLABSIs The peripherally inserted central catheter (PICC) is a central vascular catheter (CVC) that is inserted through elbow, forearm, or upper arm veins and places the catheter tip into the central vein. According to Morikane et al. (2009), it has been reported that PICC procedures reduce the rate of central line-associated bloodstream infection (CLABSI) by approximately 45 percent compared with that of CVC procedures through the subclavian vein or internal jugular vein. In addition, the total cost of treatment per hospitalization decreases, given that the CLABSI-related cost of antibiotics (some ¥410,000 per infection) and additional hospitalization (about 22 days per infection) can be avoided.

Further, use of PICCs not only reduces the incidence of infection on insertion, but can ensure safety. The anti-reflux PICC reportedly decreases the risk of catheter occlusion caused by the anti-reflux valve, which is designed to resist backflow when the catheter is not being used.8-18 Current Policy In Japan, medical fees are set without taking into account the possible use of medical devices to prevent CRBSI, and the pricing rules for Special Treatment Materials also lacks incentives for developing such devices.

Moreover, according to Japan’s Special Treatment Materials system, PICCs are classified as central venous catheters, which are further divided into subcategories, such as standard type and antithrombotic type. In April 2010, when the anti-reflux valve PICC was introduced, the reimbursement that was set for the standard type catheter (single lumen: ¥1,740; multilumen ¥2,870) was revised to ¥13,800. Following the 2012 revision, however, the reimbursement is now set at ¥12,900. As a result of the revisions that have taken place, the gap has closed between the price of a single lumen anti-reflux PICC (basic kit: ¥16,000; microintroducer kit: ¥24,000) and the reimbursement. This, in turn, has reduced the incentive for hospitals to purchase PICCs, since hospitals where the DPC/PPS system has been introduced, avoid using expensive products, even if they help prevent infection.

In the case of double lumen anti-reflux PICCs (basic kit: ¥32,000; microintroducer kit: ¥40,000), the gap between the hospital purchasing price and the reimbursement is significant. Therefore, for financial reasons, hospitals may avoid using these catheters, setting aside necessity and high clinical efficacy. Although the material costs may rise with the use of PICCs, overall, use of these catheters will put downward pressure on the cost of both medical insurance and medical care, given the fees derived from medical treatment and the management of complications, while patient safety is ensured.

Recommendations • The Japanese government should encourage medical institutions to use innovative medical products as an integral part of their infection control policies.

• Medical fees should reflect the cost and use of medical devices and materials, in both inpatient and outpatient settings.

• Reimbursements for PICCs should be revised upward, considering the clinical efficacy and economic efficiency of PICCs from a healthcare perspective.

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References

1. Yokoe, D.S., Classen, D. 2008. Improving patient safety through infection control: A new healthcare imperative. Infection Control Hospital Epidemiology 29:S3–S11.

2. Policies and procedures for infusion nursing, 3rd ed. Infusion Nurses Society.

3. Infusion nursing standards of practice. 2006. Journal of Infusion Nursing 29(1S):35–36.

4. Centers for Disease Control and Prevention. August 2002. Guideline for Prevention of Intravascular Catheter-Related Infections. (Subsequently replaced by updated guidelines on April 1, 2011.)

5. Centers for Disease Control and Prevention. April 1, 2011. Guidelines for the Prevention of.

Intravascular Catheter-Related Infections. http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011.html 6. Jarvis, W.R., Murphy, C., Hall, K.K., et al. 2009, Health care-associated bloodstream infections associated with negative- or positive-pressure or displacement mechanical valve needleless connectors. Clin Infect Dis 49:1821–7.

7. Centers for Disease Control and Prevention. April 1, 2011. Guidelines for the Prevention of.

Intravascular Catheter-Related Infections. http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011.html 8. Centers for Disease Control and Prevention. April 1, 2011. Guidelines for the Prevention of.

Intravascular Catheter-Related Infections. http://www.cdc.gov/hicpac/BSI/BSI-guidelines-2011.html 9. Crnich, Christopher J., Dennis, Maki G. 2002. The promise of novel technology for the prevention of intravascular device-related bloodstream infection. II. Long-term devices. Clinical Infectious Disease (May 15) 34:1362–1368.

10. Morikane, Keita, et al. 2009. Multifaceted comparison of peripherally inserted central catheters (PICCs) with conventional central venous catheters (CVCs). Japanese Journal of Environmental Infections 24:325–331.

11. McGee, David C., et al. 2003. Preventing complications of central venous catheterization. New England Journal of Medicine (Mar 23) pp. 1123–1133.

12. National Institute for Clinical Excellence Technology Appraisal. 2002. Guidance on the use of ultrasound locating devices for placing central venous catheters no. 49.

13. Japanese Society for Quality and Safety in Healthcare Committee. Pursuing safety for procedures with serious risk—creating and complying with a safety policy of CVC procedures. 2008. How to Guide, ver. 2. Joint Commission on Medical Safety and Collective Action Plans in Japan.

14. Hinson, Edith Kathryn, Blough, Lauren D. 1996. Skilled IV therapy clinicians’ product evaluation of open-ended versus closed-ended valve PICC lines—a cost savings clinical report. Journal of Intravenous Nursing (July/Aug ) 19(4):198–210.

15. Low infection rate from PICCs (evidence Level I). In the Guidelines for the prevention of intravascular catheter-related infections (2002), use of PICCs was reported to have caused fewer instances of CRBSI than conventional CVCs. In the meta-analysis by Crnich et al. (2002), it was reported that, when catheter insertion exceeds 1,000 days, PICCs had a statistically lower rate of CRBSI occurrence (0.4) than non-tunnel CVCs without coating (2.3).

16. Lower infection rate for anti-reflux valve PICCs (domestic, evidence Level II). According to Morikane et al. (2009), the number of CRBSIs occurring when catheter placement exceeds 1,000 days is 5.6 for anti-reflux valve PICCs and 7.0 for non-tunnel CVCs. When a logistic regression analysis was conducted on CRBSI factors, it was reported that anti-reflux valve PICCs were a factor (odds ratio 0.55, p = 0.019) that significantly reduced the risks of CRBSI occurrence. (The infection rate with 100 units can be translated into 17.8 percent for CVCs and 9.8 percent for PICCs.) 17. Safety of PICC insertion (evidence Level I–III). According to McGee et al. (2003), it is said there is roughly a 10 percent possibility of mechanical complications (including arterial puncture, hematoma, pneumothorax, and hemothorax) occurring for each CVC placement inserted through subclavian, internal jugular, and femoral veins (evidence Level I). Furthermore, the British National Health Service (2002) reported one fatality from among 3,000 CVC procedures as a result of a procedureinduced pneumothorax. Based on these findings, in 2008 the Japanese joint commission on medical safety and collective action plans published the second version of a how-to guide, in order to “prevent fatalities attributable to mechanical complications.” The book recommends that insertion through the subclavian or internal jugular vein should be avoided, and that the procedure should, instead, be from the upper arm, where safety can be assured, with mechanical complications reduced 10 percent, safety ensured, medical costs resulting from complications reduced, adverse

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physicianâ&#x20AC;&#x201C;patient relations avoided, and the overall quality of healthcare improved. PICCs are considered extremely safe, both theoretically and clinically, and can be inserted without serious complications. In fact, Morikaneâ&#x20AC;&#x2122;s multicentre trials reported no serious complications following insertion of anti-reflux valve PICCs. 18. Low occlusion rate and simple care and maintenance with anti-reflux valve PICCs (evidence Level III). According to a cost savings clinical report (evidence Level III) by Hinson et al., (1996), antireflux valve PICCs have a lower catheter occlusion rate compared with standard PICCs. In addition, with the lower frequency of medication use to prevent occlusions and fewer catheter replacements, cost relative to care and maintenance reportedly can be reduced. Furthermore, since a heparin lock is not necessary, anti-reflux valve PICCs are suitable for intermittent chemotherapy and infusion therapy by homecare workers.

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33. Prevention of Catheter- Related Blood Stream Infections: Guidelines 2008] SHEA,IDSA “Strategies to prevent central line-associated bloodstream infections (CLABSI) in acute care” Do not routinely use positive-pressure needleless connectors with mechanical valves before a thorough assessment of risks, benefits, and education regarding proper use (B-II) (Maragakis et al., 2006; Field et al., 2007; Salgado et al., 2007; Rupp et al., 2007).

Routine use of the currently marketed devices that are associated with an increased risk of CLABSI is not recommended.

2011 CDC - Guidelines for the prevention of intravascular catheter-related infections

When needleless systems are used, a split septum valve may be preferred over some mechanical valves due to increased risk of infection with the mechanical valves [197–200]. Category II ] From the above, increases of BSI is thought to be caused by inappropriate infection prevention, device design, or both, and it is necessary to understand the features of each device when selecting and using the device. It is necessary to reconfirm the management of infusion both in terms of software and hardware, e.g. whether or not CRBSI can be achieved, the appropriate use of the device, and whether other measures for infection prevention have been fully considered.

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34. Avoid Reuse of Single-use Devices

Situation Single-use medical devices (SUDs) are designed to be discarded after one use and should not be reused under any circumstances. The one-time use of a SUD ensures function and sterility, while preventing cross-contamination and infection. Only SUDs that have gone through appropriate reprocessing, including cleaning, functional testing, repackaging, relabeling, disinfection and sterilization, should ever be reused. However, some healthcare personnel are unaware of, do not understand, or do not adhere to, the guidelines for the appropriate use of SUDs.1–10 Inappropriate reuse of SUDs poses a serious health risk to patients, while reuse and reprocessing of SUDs raises legal and ethical questions. The small number of studies that have considered the clinical outcomes associated with the use of reprocessed SUDs are of variable quality and provide insufficient evidence to establish the safety and efficacy of their use. Use of several types of reprocessed SUDs is cost-saving only if it is assumed that there are no adverse effects. However, there is insufficient data to establish the costeffectiveness of re-using SUDs. Those who fund and use SUDs should consider relevant legal, ethical, and psychosocial issues. In hospital settings in Japan, infection control personnel are employed to conduct surveillance, monitor practices, and provide education and training on appropriate infection control practices. However, specific infection control resources have traditionally been lacking in outpatient settings.11–16 Current Policy In December 2007, the Ministry of Health, Labour and Welfare issued an official notice, Incidence of nosocomial infections related by medical treatment and the importance of thorough safety management structure.17 The notice was a follow-up to one issued in 2004, intended to highlight the problem of SUD reuse, and to enhance healthcare facility prevention measures from a medical safety and infection prevention perspective.18 Since 2001, the Japanese government has directed the drive for the specification of single use in SUD package inserts.

Recommendations • Enforce compliance with best practice infection control guidelines. National regulations should be developed to ensure that outpatient facilities adhere to standard infection control precautions and aseptic techniques regarding the transmission of infectious disease in healthcare settings.

• Increase oversight of healthcare facilities to ensure implementation of best practices.

National standards for oversight should be developed and enforced to enhance inspection and regulation of healthcare facilities.

• Enhance education and training of healthcare workers on infection prevention techniques. In order to address the inconsistencies in adherence to infection control guidelines, infection prevention education and training programs should be developed that include the proper use and handling of SUDs and are targeted to healthcare workers in outpatient settings.

• Encourage adoption of technologies to prevent SUD reuse. Efforts should be made to enhance uptake of existing technologies designed to prevent reuse and support development of new technologies to address this problem.

• Conduct outreach efforts to enhance patient awareness of appropriate use of SUDs. Public outreach initiatives should be developed to educate patients about the appropriate use of needles, syringes, and other-use devices.

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References

1. Yamaguchi University Medical Association. 2009. The current state of re-sterilization of single-use equipment in the operating room. Yamaguchi Medical Journal 58(5):224–225.

2. 2009–10. The risk of re-sterilization and the safe use of disposable products. Yamaguchi Medical Journal 58(5):228–230.

3. Japanese Society of Medical Instrumentation. 2004. Survey on the use of re-sterilized single-use equipment. The Japanese Journal of Medical Instrumentation 74(6):324–331.

4. 2004. The current state of re-sterilization of single-use medical equipment. The Japanese Journal of Medical Instrumentation 74(4):159.

5. Japan Society of Gynecologic and Obstetric Endoscopy and Minimally Invasive Therapy. 2005.

Japanese Journal of Gynecologic and Obstetric Endoscopy 21(1):160.

6. Japanese Association for Operative Medicine. 2004. Journal of Japanese Association for Operating Room Technology 25(2):111–114.

7. Japanese Society of Medical Instrumentation. 2002. The issue of reusing single-use equipment. The Japanese Journal of Medical Instrumentation 72(4):154.

8. 2003. The Japanese Journal of Medical Instrumentation 73(4):215.

9. Akita Association of Rural Medicine. 2003. Akita Journal of Rural Medicine 48(2):44.

10. Medtronic Japan Co., Ltd. 2010. Risk of use of worn tool bar for craniotomy.

11. Thompson, N.D., Perz, J.F., Moorman, A.C., Holmberg, S.D. 2009. Nonhospital health care-associated hepatitis B and C virus transmission: United States, 1998–2008. Annals of Internal Medicine 150:33– 39. www.annals.org.

12. U.S. Food and Drug Administration, Center for Devices and Radiological Health. 2000. Guidance for industry and for FDA staff: Enforcement priorities for single-use devices reprocessed by third parties and hospitals. Appendix B: Definition of terms. Rockville, MD: U.S. Food and Drug Administration. www.fda.gov/cdrh/reprocessing/1168.html#_Toc492780057.

13. Miller, M.A., et al. 2001. Canada communicable disease report 27(23):193–9.

14. Canadian Healthcare Association. 1996. The reuse of single-use medical devices: Guidelines for healthcare facilities. Ottawa: CHA Press.

15. Ontario Hospital Association. 2004. Executive summary. Reuse of single-use medical devices (Jan 12). www.oha.com/oha/reports.nsf/($Att)/pspr5w8qex/$FILE/ReuseofSingleUse_Medical_Devices_ Executive_Summary.pdf.

16. Day, P. 2004. What is the evidence on the safety and effectiveness of the reuse of medical devices labeled as single use only? NZHTA Tech Brief Series 3(2). Christchurch, N.Z.: New Zealand Health Technology Assessment. http://nzhta.chmeds.ac.nz/publications/medical_devices.pdf.

17. Ministry of Health, Labour and Welfare. 2007. Iseishihatsu #1228001 (December 28).

18. 2004. Iseishihatsu #0209003 (February 9).

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Introduction to the Need for a Special Focus on Healthcare Worker Safety

There is still room for improvement in the area of safety and infection control for patients and healthcare workers by lowering the risk of foreseeable accidents, injuries, preventable infection and preventable exposure to hazardous chemical agents.

The toll of healthcare workplace injuries and illnesses is also a significant problem that needs to be addressed through national policies. For workers in every industry and every sector of the economy, the prevention of avoidable and foreseeable accidents, injuries and exposure to hazardous biological and chemical risks is taken for granted as a matter of occupational health and safety under applicable law.

Implementing comprehensive guidelines and mandates to enhance safety for patients and healthcare workers would yield three positive outcomes: raising the quality of care; reducing avoidable accidents and injuries; and acting as an effective control on healthcare costs.

Occupational exposure to dangerous biological agents, such as blood-borne pathogens, including hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV), poses a serious health and safety risk to healthcare workers worldwide.

Even the smallest skin puncture caused by a needle or other sharp device can expose healthcare workers or healthcare facility employees to more than 30 blood-borne pathogens,1 which can cause serious and potentially life-threatening infections. In addition, only the slightest amount of infected plasma is required for HBV transmission.2 Nurses are subject to the largest number of blood exposures because these events occur most often in patient rooms and the operating theatre. However, doctors and ancillary medical staff—including lab professionals and housekeepers—are also vulnerable to blood exposures before, during and after use if contaminated products are not properly handled and disposed.

With the use of safety-engineered devices and the application of best practices for infection control, however, the majority of these exposures are preventable.3 The World Health Organization (WHO) has identified healthcare-associated infections (HAIs) as a leading cause of preventable morbidity and mortality.4 The cost of treating avoidable HAIs is substantial and could be reduced significantly with enhanced safety and infection control.

The safety of healthcare workers is invaluable not only for the workers themselves, but also for their families, workplaces, communities, industrial sectors and the nation as a whole. For the prevention of foreseeable accidents, it is necessary for the government, employers, workers and all parties concerned to comprehensively and systematically implement preventive measures in an integrated manner.

Healthcare workers who transport, prepare, administer and dispose of hazardous drugs can be exposed to these toxic chemical agents in the air or on work surfaces, clothing, medical equipment and other surfaces. As a result, both clinical and nonclinical workers are at risk for exposure when they create aerosols, mix liquids, generate dust, or touch contaminated surfaces if safe handling precautions are not followed.

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Frequent exposures to even very small concentrations of powerful drugs used for cancer chemotherapy, antiviral treatments, hormone regimens and other therapies have serious health consequences for workers who come in contact with them.5 National guidelines in the United States have been established for handling hazardous drugs, but compliance with these guidelines is not required and adherence has been reported to be sporadic.6â&#x20AC;&#x201C;9 In 2004, the U.S. National Institute for Occupational Safety and Health warned the public that working with or near hazardous drugs in healthcare settings may cause skin rashes, infertility, miscarriage, birth defects, and possibly leukemia or other cancers that can be irreversible even after low-level exposures.10 The lack of adherence to existing voluntary guidelines is a safety risk for healthcare personnel and comprehensive standards must be developed and enforced to ensure the safe handling of hazardous drugs.

Employers have a responsibility to eliminate or control foreseeable workplace risk. For healthcare workers, sharp object injuries are a foreseeable workplace risk and have been identified internationally as being a significant problem, particularly needle stick injuries and the exposure to hazardous drugs. The greatest risk from needle stick injuries is transmission of blood-borne viruses such as HBV, HCV, and HIV. As a result of the increase in the handling of hazardous chemical agents, the WHO predicts a 50 percent increase of cancer cases over the next 20 years as the population ages.11 The increasing number of cancer cases will also require more potent chemotherapy drugs and will elevate the risk for exposure by healthcare workers to such drugs.

In many circumstances, investigational and experimental drugs are considered hazardous until proven otherwise. In addition, chemotherapy drugs and other hazardous drugs are reportedly used to treat non-malignant diseases like arthritis and multiple sclerosis. Uses for them have also expanded into the veterinary field.

In sum, in the shift to a prevention-oriented paradigm, policies specifically directed at the enhancement of patient and healthcare worker safety and the prevention of the exposure to hazardous biological and chemical risks have been insufficient.

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References 1.

Tarantola A, Abiteboul D, Rachline A. Infection risks following accidental exposure to blood or body fluids in health care workers: A review of pathogens transmitted in published cases. Am J Infect Control, 2006; 34:367–75.

2. Strauss K, Onia R, Van Zundert A A J, ACTA Anesthesiologica Scandinavica (2008) 52, 798–804, Peripheral intravenous catheter use in Europe: towards the use of safety devices.

3. Jagger J, et al., “The Impact of U.S. Policies to Protect Healthcare Workers from Bloodborne Pathogens: the Critical Role of Safety-Engineered Devices,” Journal of Infection and Public Health, Vol. 1, Issue 2, pp. 62–71, 2008.

4. World Health Organization, “Global Status Report on Noncommunicable Disease” (2010).

5. National Institute for Occupational Safety and Health. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. 2004; 1­–4.

6. Valinis B, McNeil V, Driscoll K. Staff members’ compliance with their facility’s antineoplastic drug handling policy. Onc Nurs Forum. 1991 ; 18 (3): 571–576. Nieweg et al. 1994.

7. Valinis B, Vollmer WM, Labuhn K, Glass A, Corelle C. Antineoplstic drug handling protection after OSHA guidelines: comparison by profession, handling activity, and work site. J Occup Med. 1992; 34: 149−155.

8. Mahon SM,Casperson DS, Yackzan S, Goodner S, Hasses B, Hawkins J, Parham J, Rimkus C, Schlomer M, Witcher V. Safe handling practices of cytotoxic drugs: the results of a chapter survey.

Oncol Nurs Forum, 1994; 21 (7): 1157−1165.

9. Newberg RMB, de Boer M, Dubbleman RC, Gall HE, Hesselman GM, Lenssen PCHP, Van Maanen LWGM, Majoor PWFM, Ouwerkerk J, Slegt JH. Safe Handling of Antineoplastic drugs. Cancer Nurs, 1994; 17:501−511.

10. National Institute for Occupational Safety and Health. NIOSH alert: preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. 2004; 1 11. World Health Organization, Genetics in Prevention Treatment of Cancer. www.who.int/genomics/about/Cancer.pdf (accessed April 28, 2012).

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35. Prevent Needle Stick and Sharp Object Injuries

Situation Needle stick and sharp object injuries pose a serious occupational risk to healthcare workers. The provision of a safe and healthy working environment is a fundamental right of every employee in Japan. Duty of care provisions within occupational health and safety legislation aim to protect people from all types of hazards and risks arising from work activities. Therefore, it is reasonable to expect that healthcare workers should be protected from exposure to dangerous blood-borne viruses, including hepatitis B and C viruses and HIV. Even the smallest puncture of the skin can expose a healthcare worker to more than 30 blood-borne pathogens,1 bacteria, and parasites, any of which can cause serious and potentially life-threatening infections. The majority of these injuries are suffered by nurses and doctors and occur in patient rooms and operating rooms. However, other medical staff can also become victims. Ancillary staff such as hospital orderlies, cleaners and laundry staff, and other downstream workers also suffer needle stick injuries.

In Japan, it is estimated that between 450,000 and 600,000 sharp object injuries occur every year, which means one in two doctors or nurses experience sharp object injuries every year. According to the Research Group of Occupational Infection Control and Prevention, in Japan in 2012, 52 percent of nurses and 35 percent of doctors experienced sharp object injuries, with the percentage increasing for doctors.2 Categorized by profession, incident rates were 9.7 for residents, 4.1 for doctors, 3.5 for nurses, and 3.0 for clinical technologists, with the degree of risk being higher for doctors calculated s (number of needle stick injuries per year for profession A) / (number of staff in profession A) x (100).

In terms of the number of reported cases, in 2010 the incidence of needle stick injuries was 6.4 per 100 occupied beds, with a significantly higher (p<0.01) rate of 7.9 at university hospitals compared with 5.3 at other hospitals. There has been a notable increase in the number of sharp object injuries caused by suture needles and pre-filled cartridge needles (insulin injection pen needles). The delay in the universal utilization of safety-engineered devices was pointed out in a 2011 report as a persistent problem in Japan.3 Current Policy In June 2011, a ministerial ordinance official notice was issued by the Ministry of Health, Labour and Welfare, regarding infection prevention in healthcare facilities. It made specific recommendations for occupational safety regarding the prevention of sharp object injuries, which include prohibiting the recapping of needles; requiring puncture-resistant sharp object collectors at bedsides; and recommending the use of safety devices.4 This is the same as the recommendation issued in February 2005, which was the first time that the recommended use of safety devices was incorporated into an official health ministry notification.

Policy Changes in the Past Year Despite repeated efforts to enhance safety and infection control, there are no mandated public policies or legislation requiring the use of safety-engineered devices or enforcement of the health ministry’s notification to prevent sharp object injuries in Japan.

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Recommendations • Educate and train healthcare workers in infection control techniques. In order to encourage compliance with infection control guidelines, infection prevention education and training programs must be developed that target healthcare workers and address sharp object injury prevention and proper disposal programs.

• Mandate safer working practices. Employers must develop and implement an exposure control plan to eliminate or minimize worker exposure to blood-borne pathogens if workers are required to handle, use, or produce an infectious material or organisms, or if they are likely to be exposed to such a material or organisms at a place of employment.

• Require the use and assessment of appropriate medical devices that incorporate safety engineered technology to prevent sharp object injury. The use of devices incorporating such technology can greatly reduce the incidence of needle stick injuries and exposure to blood-borne pathogens. Healthcare facilities should be required to adopt and regularly evaluate engineering controls designed to prevent percutaneous injuries.

• Promote the use of blunt suture needles to prevent needle stick injuries in operating rooms.

• Promote the use of safety engineered insulin pen needle devices to prevent needle stick injuries during in-patient care of diabetic patients. Provide additional medical fees to cover the cost of enhanced safety.

• Eliminate the use of needles where safe and effective alternatives are available.

Whenever possible, encourage the use of devices that eliminate the need for needles in order to reduce the potential for occupational exposure to blood-borne pathogens due to percutaneous injuries from contaminated sharp objects.

• The United States, the 26 countries of the EU, as well as Canada and Taiwan have all enacted laws that provide a safer workplace for healthcare workers by reducing the risk of deadly blood-borne infection transmissions. Many other countries around the world are now considering similar healthcare work occupational health and safety legislation. There is an urgent need for Japan to enact and enforce occupational health and safety legislation that mandates the use of safety-engineered devices whenever possible.

References

1. Tarantola, A., Abiteboul, D., Rachline, A. 2006. Infection risks following accidental exposure to blood or body fluids in healthcare workers: A review of pathogens transmitted in published cases. American Journal of Infection Control. 34:367–75.

2. Kimura, S. 2003. Research of the status of needlestick injuries and prevention among healthcare workers. Japan Ministry of Health, Labour, and Welfare science research grant project (March):3–7.

3. Japan-EPINet Survey Working Group. 2011. Summary of the survey published by the Research Group of Occupational Infection Control and Prevention in Japan. http://jrgoicp.umin.ac.jp/.

4. Ministry of Health, Labour and Welfare. Iseishihatsu-0617.

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35. Comprehensive Guidelines and Mandates to Enhance Safety for Healthcare Workers

Medical Care Act 2012 Taiwan, first country in Asia to pass mandatory use of safety needles legislation

35. Sharps Injuries from Suture Needles, Pre-filled Cartridge Needles Increasing

Devices used for Insulin injection

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Source: Japan EPINet data (FY1996-2011) http://jrgoicp.umin.ac.jp

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35. Low Dissemination of Safety-engineered Devices Is an Issue ÂŁ

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35. Many Needlestick Injuries Caused by Safety Devices for Winged Steel Needles 2009â&#x20AC;&#x201C;2010 EPINet DATA

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Source: Japan EPINet data (FY2009-2010) http://jrgoicp.umin.ac.jp/

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35. Reducing Risks for Patients, Healthcare Workers and the Public Examples of Safety-Engineering Before Use

After Use

Syringes Vacuum tube blood collection needles Winged steel needles (butterfly needles) IV catheters Surgical blades Lancets What is a Safety-Engineered Device?] It is Ya non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administrating medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure.â&#x20AC;? OSHA 29CFR 1910.1030(b)

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36. Safe Handling of Hazardous Drugs to Protect Healthcare Workers

Situation Healthcare personnel who transport, prepare, administer, and dispose of hazardous drugs can be exposed to these toxic agents in the air or on work surfaces, clothing, medical equipment, and other surfaces. As a result, both clinical and nonclinical workers are at risk for exposure when they create aerosols, mix liquids, generate dust, or touch contaminated surfaces if safe handling precautions are not followed. Frequent exposures to even very small concentrations of powerful drugs used for cancer chemotherapy, antiviral treatments, hormone regimens, and other therapies have serious health consequences for workers who come in contact with them.1 Drugs defined as hazardous exhibit one or more of the following characteristics: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, and genotoxicity.2 These hazardous drugs, which include antineoplastics, are primarily drugs used to treat cancer. Antineoplastic agents were initially developed from chemical agents introduced as nitrogen mustard during World War I. The same mechanisms that kill cancer cells can be damaging to healthy cells. Hazardous drugs are not limited to just antineoplastics; they include antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs.3 The National Institute for Occupational Safety and Health (NIOSH) revised the American Society of Health-System Pharmacists (ASHP) definition of hazardous drugs. It identified approximately 150 drugs as hazardous, including 30 International Agency for Research on Cancer (IARC) known carcinogens.4, 5, 6 In the United States alone, approximately 8 million healthcare workers are involved in nursing, pharmacy, transport, and the cleanup of chemotherapy waste.7 Many of these workers are not properly trained to handle exposures to hazardous drugs. In addition, some healthcare personnel experience barriers to accessing proper engineering controls and protective equipment. The volume of hazardous drug use will increase over time. In fact, the World Health Organization predicts a 50 percent increase of cancer cases over the next 20 years as the population ages.8 The increasing number of cancer cases will also require more potent chemotherapy drugs and will elevate the risk of exposure for healthcare workers. In addition to use in chemotherapy, investigational and experimental drugs are considered hazardous until proven otherwise. In addition, chemotherapy drugs and other hazardous drugs are used to treat non-malignant diseases, such as arthritis and multiple sclerosis, and their use is expanding in the veterinary field.

A study conducted by the University of Michigan on ambulatory oncology nurses discovered that the overall rate of exposure to the skin or eyes over a one-year period among 1,339 nurses surveyed was 16.9 percent.9 In addition, a study conducted by NIOSH demonstrates that the surfaces in healthcare facilities are typically contaminated with antineoplastic drugs, and that contamination may lead to worker exposure.10 This is consistent with studies published in the United States and many other countries around the world. In response to this information, the Joint Commission, the Occupational Safety and Health Administration (OSHA), and NIOSH issued a joint letter to healthcare facilities in the United States urging them to re-evaluate their safe handling practices related to hazardous drugs, and alerting them to the 2010 updated NIOSH hazardous drug list. However, adherence to national guidelines remains sporadic, and comprehensive standards are required to adequately protect healthcare personnel from hazardous drugs.

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Effects of Exposure to Hazardous Drugs Results show that coming into contact with hazardous agents can cause numerous problems. Exposed healthcare workers experienced higher rates of spontaneous abortions and potential fetal malformations. Lawson et al. recently reported a statistically significant, nearly twofold increase in risk for spontaneous abortions among nurses exposed to antineoplastic agents during the first trimester.11 Workers reported that they were experiencing side effects similar to those of a chemotherapy patient (hair loss, vomiting, mouth sores, and skin rashes).12, 13 Additionally, the incidence of cancer in these workers was higher, especially for leukemia and bladder cancer.14, 15 The Kaiser Permanente Center for Health Research published a study showing that exposure of pregnant women handling antineoplastic agents during pregnancy was associated with an increased risk for spontaneous abortions and stillbirth. In 2005, a survey of 7,500 members of the Oncology Nursing Society found a significant increased risk for infertility and miscarriage among nurses under 25 years of age working with chemotherapy.16 Current Policy In the 2012 medical fee revision, the technical fee for mixing of anticancer agents in a sterile setting was raised; however, this applies to only three agents. Therefore in Japan, many institutions use closed system transfer devices (CSTDs) only for these three agents, while other agents are still prepared without CSTDs, as opposed to the situation in the United States and elsewhere, where CSTDs are used for any hazardous agents.

Further, in Japan the concept of a hazardous drug is not widely recognized. Medical professionals handling hazardous drugs should be aware that they are at health risk and take extra precautions when handling such agents.

In order to fully enforce the safe handling of hazardous drugs, there should be an increase in both the fee and the range of agents covered.

Recommendations • Evaluate the healthcare workplaces to identify and assess hazards.

• All healthcare settings, places dispensing veterinary medicine, research laboratories, retail pharmacies, and home healthcare agencies must catalogue the types of drugs, their volume, the frequency of shipment, and the form of the drugs being handled at the facility. In addition, facilities should complete a work environment inventory that includes a catalogue of equipment designed to reduce exposure to hazardous drugs as well as the physical layout of work areas.

• Management policies and training programs must be set up to handle hazardous drugs.

• Administrative controls must be established at facilities that handle hazardous drugs, in order to address preparing, administering, and disposing of the agents. Policies and training programs should be instituted to address: the presence of hazardous drugs, labeling, storage, spill control, personnel issues (exposure of pregnant workers), and detailed procedures for preparing, administering, testing for surface contamination, and disposing of hazardous drugs.

• Comprehensive use of equipment designed to reduce exposure to hazardous drugs should be required.

The use of personal protective equipment (PPE), ventilated cabinets (Class II or III biological safety cabinets [BSC] or a compounding aseptic containment isolators [CACI] that meet USP 797 requirements), and engineering controls that are 174 | Lengthening Healthy Lifespans to Boost Economic Growth

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•

clinically proven (such as CSTDs) are recommended by NIOSH, the International Society of Oncology Pharmacy Practitioners (ISOPP), the ASHP, the Oncology Nursing Society (ONS), and the U.S. Pharmacopeia 797 (USP 797)17, 18, 19, 20, 21 and should be required to help prevent occupational exposure to hazardous drugs.

Increase and standardize efforts to survey and report exposures to hazardous drugs.

All incidents in healthcare settings related to hazardous drug exposure, spills, and splash should be reported to management and report data should capture the worker’s past exposure, medical history, and ongoing monitoring of blood and urine tests to help determine linkage to exposure and facilitate long-term epidemiological review. State cancer registries must capture the occupation of cancer patients to assist in efforts to identify the cause of the cancer nationally.

References

1. National Institute for Occupational Safety and Health. 2004. NIOSH alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings pp. 1–4.7.

2. Ibid. p. 32.

3. Ibid. p. 31.

4. Center for Disease Control. 2010. NIOSH List of antineoplastics and other hazardous drugs in healthcare settings. www.cdc.gov/niosh/docs/2010-167/pdfs/2010-167.pdf.

5. American Society of Health-System Pharmacists. 2006. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 63:1172–93.

6. International Agency for Cancer Research. IARC monographs on the evaluation of carcinogenic risks to humans. http://monographs.iarc.fr/ENG/Classification/index.php.

7. Centers for Disease Control and Prevention. Hazardous drug exposures in health care. www.cdc.gov/niosh/topics/hazdrug/#a.

8. World Health Organization. Genetics in prevention treatment of cancer. www.who.int/genomics/about/Cancer.pdf.

9. Friese, C.R., Himes-Ferris, L., Frasier, M.N., et al. 2011. BMJ Qual Saf Doi:10.1136/ bmjqs-2011-000178.

10. Connor, T.H., DeBord, D.G., Pretty, J.R., Oliver, M.S., Roth, T.S., Lees, P.S.J., Krieg, E.F. Jr., Rogers, B., Escalante, C.P., Toennis, C.A., Clark, J.C., Johnson, B.C., McDiarmid, M.A. 2010. Evaluation of antineoplastic drug exposure of health care workers at three university-based U.S. cancer centers. J Occup Environ Med 52(10):1019–1027.

11. National Institute for Occupational Safety and Health. pp. 14–15.

12. Lawson, C.C., Rocheleau, C.M., Whelan, E.A., Hilbert, E.N.L., Grajewski, B., Spiegelman, D., Rich-Edwards, J.W. Occupational exposures among nurses and risk of spontaneous abortion.

American Journal of Obstetrics and Gynecology. 2012:206 E-pub ahead of print doi.org/10.1016/j. ajog.2011.12.030.

13. Valanis, B.G., Herzberg, V., Shortridge, L. 1987. Antineoplastic drugs: handle with care. AAOHN J. 35:487–92.

14. Valanis, B.G., Vollmer, W.M., Labuhn, K.T., et al. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. 1993. Am J Hosp Pharm 39:141–7.

15. National Institute for Occupational Safety and Health. p. 6.

16. Washburn, D.J. 2007. Intravesical antineoplastic therapy following transurethral resection of bladder tumors: Nursing implications from operating room to discharge. Clinical Journal of Oncology Nursing 11(4).

17. National Institute for Occupational Safety and Health. pp. 14–15.

18. International Society of Oncology Pharmacy Practitioners. 2007. ISOPP Standards of Practice. Journal of Oncology Pharmacy Practice. 13(Suppl):1–81.

19. American Society of Health-System Pharmacists. Op cit.

20. Polovich, M. 2011. Safe Handling of Hazardous Drugs, second ed. Oncology Nursing Society.

21. USP 797 2008. Guidebook to pharmaceutical compounding—sterile preparations. United States Pharmacopeial Convention, pp. 37–38.

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36. Safe Handling of Hazardous Drugs to Protect Healthcare Workers • Antineoplastic agents and other hazardous drugs are powerful drugs. As there is evidence that many of them can cause cancer, and evidence that they may cause reproductive and developmental problems, fetal malformations, genotoxicity, and organ damage, it is prudent to be aggressive about safe handling and the use of closed system transfer devices (CSTD).

• In the 2012 medical fee revision, the technical fee for mixing of antineoplastic agents in a sterile setting was raised; however, this applies to only three agents. Therefore in Japan, many institutions use closed system transfer devices (CSTD) only for these three agents, while other agents are still prepared without CSTDs, as opposed to the situation in the U.S. and elsewhere, where CSTD are used for any hazardous agents.

36. Safe Handling of Hazardous Drugs to Protect Healthcare Workers Medical Fee Revision in 2012 • Reward for handling volatile drugs

“It has been pointed out that among anti-cancer drugs, there are agents that show carcinogenicity. In addition to skills needed for handling other agents, additional high level of different skills and safety control are required particularly for handling agents with high volatility in order to prevent exposure to the agents and environmental pollution; therefore, the techniques should be rewarded.”

Source: Medical Fee Revision 2012, Health Insurance Bureau, MHLW.

- Additional Insurance Points for Sterile Preparation OA. When “closed system connector is used”

[O(1) Volatile agents* : 150 insurance points

[O(2) Other than (1): 100 insurance points

* Ifosfamide, Cyclophosphamide, Bendamustine

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36. Safe Handling of Hazardous Drugs to Protect Healthcare Workers Reimbursement Reimbursement levels levels for for preparation preparation

Japan Reimbursement policy - Use of CSTDs Category G020

No No use use of of CSTDs CSTDs

Use Use of of CSTDs CSTDs • If hospital uses a CSTD for a preparation, they receive ¥1,000 (100 points), and not ¥500

• For drug preparation, hospitals receive ¥500 (50 points)

• Conditions to receive reimbursement for preparation of doses: Ø Be a hospital with more than 20 beds Ø Prepare drugs in aseptic conditions (clean rooms, BSCs or clean bench) Ø Preparation has to be done by a certified pharmacist for oncology

• Conditions to receive the reimbursement for preparation of doses with a CSTD are: Ø Fulfill the same requirements as when not using CSTDs Ø Patient’s name and brand of CSTDs used have to be mentioned in the reimbursement process

CSTD CSTD for for 33 drugs drugs • Receive extra ¥500 (50 points) with preparation for 3 volatile drugs (Cyclophosphamide, Ifosfamide, and Bedamustine) • Hospital receives ¥1,500 (150 points)

CSTD CSTD for for other other drugs drugs

• Hospital receives ¥1,000 (10 points)

For preparation, hospitals receive either ¥500 if they do not use CSTDs, ¥1,000 if they use CSTDs (¥500 more), or ¥1,500 if they use CSTDs for 3 volatile drugs.

Source: Ministry of Health, Labour and Welfare www.mhlw.go.jp/bunya/iryouhoken/iryouhoken15/dl/2-5.pdf (in Japanese, accessed Jan. 18 2013.)

36. Safe Handling of Hazardous Drugs to Protect Healthcare Workers Hierarchic order in protection measures

—ISOPP (International Society of Oncology Pharmacy Practitioner)—

Most Effective

Prevention

Protection

Level 1: Elimination, substitution, replacement ]]]] Replace the product by a less or nontoxic one Level 2 Isolation of the hazardous/source containment Use of closed systems to prevent the occurrence of any form of contamination

Level 3 Engineering controls/ventilation Evacuation local extraction or general ventilation = BSC, isolators, …

Level 3B Administrative controls/organization measures Organize the work in such a way that the duration of exposure/ the number of employees exposed is reduced Level 4 Personal Protective Equipment PPE) Individual protection measures = PPE

Less Effective

May 2013

Sources ISOPP standards and practice](2009) pp.18-19 ONS Safe Handling of Hazardous Drugs 2nd edition (2011) EU Directive(90/394/EEG): Official Journal of the European Union L 158

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