MN Health Care News Apr 2016

April 2016 • Volume 14 Number 4

Positive psychiatry

By Dilip V. Jeste, MD

Arthritis

By Zaki Abou Zahr, MD

Asthma

By Allan Stillerman, MD

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CONTENTS

4 7 8

APRIL 2016 • VOLUME 14

16

NEWS

NUMBER 4

PULMONOLOGY

Asthma An Olympic athlete’s story

PEOPLE

PERSPECTIVE

M edical-legal partnerships A lawyer on the health care team

Mitchell Hamline School of Law

10

10 QUESTIONS

MNsure: shopping for health care Allison O’Toole, JD

18 20

CALENDAR

OPHTHALMOLOGY Conjunctivitis Causes and remedies

22

TAKE CARE

12

Positive psychiatry A new approach

By Dilip V. Jeste, MD

14

CHRONIC DISEASE Rheumatoid arthritis Treatment and relief from joint pain

Medical Innovation vs.

Medical Economics When payment policies limit quality of life

Brain Health Maintaining proper function

By Scott Hoppe, DC

24

CARDIOLOGY Hypertension The “silent killer”

By Thomas Knickelbine, CEO, MNsure MD, FACC, and Gretchen Benson, RDN, CDE

BEHAVIORAL HEALTH

FORTY-FIFTH SESSION

By Allan Stillerman, MD

By Tina McCarty, OD, Jada Fehn, JD FAAO

MINNESOTA HEALTH CARE ROUNDTABLE

26

E LDER CARE

Senior Nutrition Addressing “food insecurity”

By Nancy Christianson

30

WOMEN’S HEALTH Abnormal bleeding Evaluation and treatment

By Matthew Palmer, DO

By Zaki Abou Zahr, MD, RhMSUS

Thursday, April 21, 2016 • 1:00-4:00 PM

The Gallery (lobby level), Downtown Minneapolis Hilton and Towers Background and Focus: The pace of innovation in medical science is rapidly escalating. From more accurate diagnostic equipment, to the use of genomic data, to better surgical techniques and medical devices, to new and more efficacious pharmaceuticals, breakthroughs occur nearly every day. These advances face many challenges when incorporated into medical practice.

Several significant factors limit this adoption, including the economic models around how patient use of new science will be utilized. Twentieth century health insurance, medical risk management, and reimbursement models are controlling 21st century medical care and patients are the losers.

Objectives: We will review examples of recent scientific advances and the difficulties they face when becoming part of best medical practice, despite their clear superiority over existing norms. We will look at prevailing thinking behind economic models that govern how health care is paid for today. Our panel of industry experts will explore potential solutions to these problems. We will look at ways to create balance between payment models, new technology, and increased quality of life.

Panelists include: • Hamid R. Abbasi, MD, PhD, FACS, FAANS; Board Certified Neurosurgeon, Tristate Brain and Spine Institute • John English, MD; PrimaCare Direct • Susan McClernon, PhD; Faculty Director, U of M Health Services Management Program Sponsors include: Tristate Brain and Spine Institute

PUBLISHER Mike Starnes | mstarnes@mppub.com

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APRIL 2016 MINNESOTA HEALTH CARE NEWS

3

NEWS

New Fetal Care Center Opens in Minneapolis Children’s Hospitals and Clinics of Minnesota and Allina Health opened a new fetal care center in Minneapolis on March 14.

The new 6,700-square-foot clinic is named the Michael and Ann Ciresi Midwest Fetal Care Center in honor of a $1 million gift from Minnesota attorney and past chair of the Children’s Foundation, Mike Ciresi, and his wife Ann. It is located within The Mother Baby Center in Minneapolis and shares space with Allina Health-operated Minnesota Perinatal Physicians. Construction began in August 2015.

The center has been providing diagnosis and treatment services for congenital conditions and abnormalities in unborn infants during high-risk pregnancies since 2008, when it was formally established as a collaboration between Children’s Hospitals and Clinic of Minnesota, Pediatric Surgical Associates, Allina Health’s Abbott Northwestern Hospital and Minnesota Perinatal

4

Physicians, and other consulting subspecialties. The $1 million gift and new center will bring technology upgrades and new specialists, such as Joseph Lillegard, MD, PhD, who was hired as research director and pediatric surgeon in July 2015 to help advance the launch of the center’s open fetal surgery program.

Strong Association Found Between Low Income and Diabetes A new report from the Minnesota Department of Health (MDH) shows that adult Minnesotans living in households earning less than $35,000 per year are almost two and a half times more likely to have diabetes than those with household incomes of more than $35,000.

The rate for diabetes in working age adults ages 18 through 64 living in households with incomes less than $35,000 is 12.5 percent, compared to 5 percent for those with household incomes above that amount.

An estimated 1 million adults in

MINNESOTA HEALTH CARE NEWS APRIL 2016

the state live in households with an annual income under $35,000.

“This research highlights the close links between health, income, and financial stability,” said Ed Ehlinger, MD, Minnesota commissioner of health. “It’s an unhealthy cycle in which low income can contribute to getting diabetes, and having diabetes can limit a person’s earnings and ability to work.”

The report also shows that adults with diabetes are more likely to be unable to work than those without diabetes—about 26 percent of those unable to work report having diabetes, compared to 4 percent of those who are employed.

The research suggests several approaches to addressing diabetes in Minnesota, including investing in prevention programs, increasing and enhancing worksite wellness programs, removing cost-related barriers to program participation, and addressing broader issues associated with poverty.

Nation’s Largest Study on Brain Trauma Launches in Minnesota Abbott Laboratories, Hennepin County Medical Center (HCMC), and the University of Minnesota are collaborating to conduct the nation’s largest study on concussions and traumatic brain injury.

Researchers hope to develop a new standard approach to classify brain injuries and provide more information to doctors to help guide treatment decisions. Currently, the standard practice for assessing brain trauma includes testing a patient’s ability to speak, follow directions, and move eyes and limbs, as well as a CT or MRI scan if deemed necessary. In the new study, researchers will use multiple evaluation tools, including eye tracking, blood-based biomarkers, imaging, and cognitive measures to gain more information.

“Imaging tells us what the brain looks like, eye tracking tells us how well it’s working, and blood-based

biomarkers can tell us the nature of the damage,” said Thomas Bergman, MD, co-investigator of the study and chief of neurosurgery at HCMC. “When we put all of this information together, we will have a better understanding about brain injury that will help us treat patients now and in the future.”

Researchers plan to screen 9,000 trauma patients and enroll a minimum of 1,000 of them in the study. Participants will range from children to the elderly and include people who are conscious as well as people in comas. The study will follow up with them for up to one year.

Abbott Laboratories researchers are developing a test to detect specific proteins in the blood that are associated with brain injury. It will be analyzed on Abbott’s i-STAT, a handheld, portable device used at a patient’s side to deliver blood test results right away. And funds from the Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program will be used for MRI imaging to look for finer structural issues in patients that may not be visible in CT scans. “We know that there are different types of brain damage that can occur after trauma, whether it’s a mild concussion or a severe injury,” said Uzma Samadani, MD, PhD, one of the lead investigators of the study. “Our goal with this study is to combine multiple assessment techniques to quickly assess the severity of brain injuries and enable clinicians to provide appropriate treatments.”

Minnesota Seeks $8.5 Million to Improve Mental Health Care The Minnesota Association of Community Mental Health Programs (MACMHP), the Minnesota Hospital Association (MHA), and Minnesota legislators from both parties are requesting $8.5 million to improve mental health and addiction services over the next three years.

If the funding is approved, it will allow Minnesota to qualify for a federal initiative to expand access to mental health care and substance abuse treatment by investing in community-based treatment centers.

Gov. Mark Dayton included the funding in his supplemental budget released on March 15.

The Excellence in Mental Health Act, enacted in 2014, created a demonstration project consisting of eight states to test Certified Community Behavioral Health Clinics, which would engage in partnerships with other health organizations to increase the likelihood of care before crisis, lessen the burden on emergency rooms, law enforcement, and families, and provide care for the patient in the right care setting.

The Minnesota Legislature funded participation in the demonstration project in 2015 and Minnesota was chosen as one of 24 states to receive a federal planning grant. The state now has until October 2016 to certify at least two providers, establish a prospective payment system for the Certified Community Behavioral Health Clinics, and secure Medicaid payments for them during the demonstration period.

Love

“This legislation has the potential to transform the delivery of mental health services, and being selected as a demonstration state ensures Minnesotans will have even greater access to high-quality, coordinated care,” said Shauna Reitmeier, CEO of Northwestern Mental Health Center and board chair of MACMHP. “This critical funding will keep us on track to improve access, quality, and coordination of mental health care by creating a ‘one-stop-shop’ for comprehensive mental health and addiction services.”

The eight mental health centers in Minnesota that will work toward becoming Certified Community Behavioral Health Clinics are Amherst H. Wilder Foundation (metro area); Canvas Health (metro area); Human Development Center (Duluth); Northern Pines Mental Health Center (Brainerd, Little Falls, Long Prairie, Staples, and Wadena); Northwestern Mental Health Center (Crookston); People Incorporated Mental Health Services (metro area); Ramsey County Mental Health Center; and Zumbro Valley Health Center (Rochester).

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Care Beyond Cost.

News to page 6 APRIL 2016 MINNESOTA HEALTH CARE NEWS

5

News from page 5

Better Birth Outcomes Found in States That Allow Midwives to Practice Independently States with laws that allow certified nurse-midwives to practice independently have more midwife-attended births and lower rates of cesarean delivery and preterm birth, according to a study from the University of Minnesota School of Public Health and George Mason University.

“In the U.S. today, nine percent of births are attended by midwives and that percentage is growing,” said Katy Kozhimannil, associate professor at the School of Public Health and senior author of the study. “The safety and effectiveness of the midwifery model of care is well-established, but current state policies are neither uniform nor consistent in how they regulate the practice of midwifery. These state policies affect women’s options for choosing a maternity care provider.”

Researchers analyzed information from birth certificates for more than 12 million U.S. births between 2009 and 2011 as well as data on midwifery practice from the American Midwifery Certification Board. They discovered that states with laws that allow certified nurse-midwives to practice independently have a larger midwifery workforce, more midwife-attended births, and better birth outcomes than states that require physician oversight or collaborative agreement. In the states that allow midwives to practice independently, there is an average of 4.85 certified nurse-midwives per 1,000 births, compared to 2.17 per 1,000 births in states with more restrictions.

Women who gave birth in states with autonomous midwife practice also had a 13 percent lower chance of having a cesarean delivery; 13 percent lower chance of having a preterm birth; and an 11 percent lower chance of delivering a low birth weight baby.

“Importantly, our analysis does not prove that changing a state’s

laws will lead directly to better birth outcomes. This was not a causal analysis,” said Kozhimannil. “However, we do find a strong association between states with midwife-friendly laws and both the supply of midwives and the outcomes of childbirth.

There are twice as many midwives in these states, and the associated outcomes we detected — lower preterm and cesarean birth rates and fewer low birth weight infants — are consistent with the results of rigorous research on midwifery care.”

Recently, a test developed by the Centers for Disease Control and Prevention (CDC) got emergency clearance from the U.S. Food and Drug Administration (FDA) for its Zika test. However, officials say this test may miss early signs of Zika because it works by detecting antibodies in blood samples. The MD Biosciences test may detect it earlier because it detects genetic signs of Zika rather than the body’s response of antibodies. It can be performed on whole blood, serum, plasma, or urine samples.

The researchers say future studies should assess if there is a causal link between midwifery policies and various health and birth outcomes.

MD Biosciences hopes to get FDA approval for the test so it can be sold to other labs. Recently, the agency asked MD Biosciences to share information about its test and regulators gave the company seven days to schedule a meeting with the FDA.

Minnesota Researchers Develop New Zika Virus Test MD Biosciences has announced the release of its rapid assay to detect the Zika virus in blood and urine samples. The company is based in Switzerland and has its U.S. headquarters in St. Paul.

“In light of the current public health emergency, it is particularly important for the FDA to review information related to your Zika Virus RNA by RT-PCR Assay’s design, validation, and performance characteristics,” the FDA said in its letter to MD Biosciences.

If you’re a Baby Boomer age 65 or older, it’s time to find your groove with Medicare. UCare is ready with health plans that are as flexible and forward-thinking as you are.

YOU

STILL HAVE ALL THE RIGHT MOVES.

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UCare for SeniorsSM lets you choose from plans that cover prescription drugs, travel, eyewear, dental, fitness programs like Healthways SilverSneakers® Fitness and more. There are low or no co-pays for primary care visits with most plans. And you’ll get to talk to a real person 24/7 when you call customer service. It’s just what you’d expect from health care that starts with you.

Learn more about the benefits of UCare for Seniors in our new eGuide to Medicare at ucareplans.org. Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534, 8 a.m. to 8 p.m. daily.

UCare for Seniors is an HMO-POS plan with a Medicare contract. Enrollment in UCare for Seniors depends on contract renewal. ©2015, UCare H2459_101512 CMS Accepted (10202012) MINNESOTA HEALTH CARE NEWS APRIL 2016 6 UC693 2015 Boomer MPP MN Health Care News_Hippie.indd 1

9/14/15 9:03 AM

PEOPLE Deb Thorp, MD, obstetrician/gynecologist at Park Nicollet, has received the 2016 Pete and Weesie Hollis Community Service Award in recognition of her outstanding work with the Somali and LGBT communities in Minnesota. Thorp created a transgender services program at the clinic in Minneapolis and conducts gender competency training Deb Thorp, MD for providers. She is the past president of Isuroon, a nonprofit organization working to promote the well-being and empowerment of Somali women in Minnesota and beyond. Thorp earned her medical degree at the University of Minnesota Medical School. She completed an internship at Cook County Hospital and a residency at the University of Minnesota. Her special interests include minimally invasive surgery, lesbian and transgender health care, adolescent gynecology, general obstetrics and gynecology, and Somali women’s health care.

Sandy Dilts, LPN

Sandy Dilts, LPN, therapeutic recreation co-director at Good Shepherd Community in Sauk Rapids, was honored by LeadingAge Minnesota with the Caregiver of the Year Award for her exceptional commitment to older adults and enhancing and enriching the quality of life of those in her care. She was selected for the award out of a field of 50,000 professional caregivers throughout the state.

Dilts has worked in long-term care for more than 45 years, all at Good Shepherd. She oversees many projects that improve the lives of residents including Senior Prom, Happy Hour, and Grandparent to Gridiron, which engages residents with members of the local high school football team in meaningful projects. She is also looked to as a project leader for significant and sustained changes in culture.

Most recently, she was part of a team that developed a new customer care standards model.

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Kathy Dunleavy, campus director of community life at Woodbury Senior Living, has received the Dedicated Service Award from Care Providers of Minnesota in recognition of her dedicated career in long-term care. Dunleavy has worked for 29 years in the profession. She is a certified therapeutic recreation specialist and is highly regarded in her department and throughout the medical community Kathy Dunleavy as a consultant in developing standards for excellent quality-of-life care. Dunleavy works to ensure there are activities that offer physical, cognitive, social, emotional, spiritual, creative, and psycho-social expression for all residents, from the very independent to residents who need more care due to Alzheimer’s or dementia.

David Fine, MD, board-certified in internal medicine and cardiology, has joined Hennepin County Medical Center at its Golden Valley Clinic and Hennepin Heart Center. He has expertise in the full spectrum of cardiology care, from preventive, consultative, and longitudinal care, to diagnostic testing and interpretation, to the performance of David Fine, MD interventional procedures including angioplasty, stent, and pacemaker implantations. Fine earned his medical degree at Johns Hopkins University Medical School.

APRIL 2016 MINNESOTA HEALTH CARE NEWS

7

PERSPECTIVE

Medical-legal partnerships A lawyer on the health care team

E

Jada Fehn, JD Mitchell Hamline School of Law Ms. Fehn is an assistant teaching professor at Mitchell Hamline School of Law and director of the medical-legal partnership with United Family Medicine. Before passing the bar, she worked for more than 10 years in mental health and pharmacy, earning both her law degree and Health Law Certificate from Hamline. She recently completed a one-year Robert Wood Johnson Foundation fellowship with the New York City Department of Health and Mental Hygiene.

ver since the Whitehall studies targeting health inequities of British civil servants were first released in the 1970s, awareness of the social determinants of health has increased. Michael Marmot, professor of epidemiology and public health at University College London, states that those lower on the social ladder run at least twice the risk of serious illness and premature death as those near the top.

People living in poverty often face unsafe housing, lack of access to nutritious foods, less leisure time for physical activity, poorer education, and more overall stress, all of which lead to poor health. Here in Minnesota and across the nation, medical professionals and attorneys are joining forces to overcome these socio-economic barriers to health.

Employment and education; Legal status; and Personal and family stability. For clients whose limited income forces them to make tough choices, such as forgoing medication to buy food, MLP teams can help secure health insurance, food stamps, and other benefits. They can also assist in the search for consistent housing, helping clients to follow their medical treatment plan and avoid emergency room visits related to homelessness. Help from a lawyer surrounding legal status can also provide opportunities for work, stability, and education—additional social factors that impact health. An established, secure family environment can diminish stress and alleviate injuries from violence.

Two professions team up

Minneapolis is home to one of the nation’s oldest MLPs. At the Deinard Legal Clinic, attorneys from Stinson Leonard Street LLP have provided free legal help since 1993 to patients of Community-University Health Care Center. The firm’s attorneys provide legal services on a pro bono basis (charging neither clients nor the health care center), but this is not the only format for MLPs.

Health care providers serving vulnerable populations see these problems firsthand. A doctor may provide an ideal treatment regimen for a child with asthma, but if the child is living in a moldy home, his condition may not improve. Another child requires a bone marrow transplant for his leukemia, but cannot return safely to a home infested with roaches. Other patients may require documentation before they can seek employment or gain access to medical coverage.

Awareness of the social determinants of health has increased.

The good news is that many of these healthrelated difficulties can have a legal remedy. A growing number of medical-legal partnership (MLP) programs follow a collaborative model, bringing legal services into health care settings serving vulnerable populations. According to the National Center for Medical-Legal Partnership, MLPs aim to “identify, treat, and prevent health-harming legal needs for patients, clinics, and populations” by integrating “the work of health care, public health, and civil legal aid.”

Most MLPs follow a similar model: an attorney works in a medical clinic, usually one that serves an impoverished or otherwise marginalized community, to provide legal services in an effort to improve health outcomes. Carrie Graf, the first MLP attorney at Hennepin County Medical Center’s Whittier Clinic, describes this work as “the result of a deeply intuitive understanding about the overlap between the goals of medicine and the law, especially when serving people living in poverty.”

Most MLPs follow the I-HELP framework. I-HELP is an acronym for Income, Housing and utilities;

8

Local examples

MINNESOTA HEALTH CARE NEWS APRIL 2016

At the Whittier Clinic, for example, an attorney employed by legal aid meets onsite with patients.

At Mitchell Hamline School of Law, certified student attorneys provide legal assistance under the supervision of a professor as a part of their practical education.

Mitchell Hamline’s MLP is partnered with United Family Medicine (UFM), a federal qualified health center. UFM provides primary care to residents in and around Saint Paul, with a focus on the medically uninsured, underinsured, and underserved and a commitment to improve the social determinants of health. A team of UFM patient advocates had previously provided social work services and legal referrals, but many clients were unable to follow up.

Having law students and attorneys dedicated solely to the patient population addressed this need.

Hope for the future

The health care and legal advocates working in MLPs in the Upper Midwest have formed a learning collaborative for continuous development and joint advocacy on a community scale. Building on local success, they hope to advance health equity by changing negative social determinants into positive ones.

rehabilitate T oowith rehabilitate aa body, body, we we start start with the the mind mind and and soul. soul.

If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. treats your body, mind and soul. That’s our approach.

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.

To make a referral or for more information, call us at To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota.

(888) GSS-CARE or visit www.good-sam.com/minnesota.

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, stateGood or local laws. Some services may housing be provided a thirdtoparty.

All faiths or beliefs are welcome.

2015color, The Evangelical Lutheran Goodfamilial Samaritan Society.

All rights 15-G1553statuses according The Evangelical Lutheran Samaritan Society provides and by services qualified individuals without regard to©race, religion, gender, disability, status, national origin reserved. or other protected to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. © 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553

APRIL 2016 MINNESOTA HEALTH CARE NEWS

9

10 QUESTIONS

MNsure: shopping for health care Allison O’Toole, JD Allison O’Toole is CEO of MNsure, overseeing an annual budget of nearly $50 million and more than 150 staff. She previously served as MNsure’s deputy director for external affairs.

What does MNsure do? MNsure is a marketplace where Minnesotans can shop, compare, and choose health insurance coverage that meets their needs. MNsure is the only place where consumers can qualify for financial help, either through federal tax credits or through Minnesota’s two public health insurance programs, MinnesotaCare and Medical Assistance.

What are the biggest challenges that MNsure has faced? It’s no secret that when MNsure launched in 2013 the result wasn’t pretty, and quite frankly former leadership set expectations way too high.

I’ve spent the past two years working to improve the consumer experience and level set with stakeholders about what MNsure is and what it can do. We’ve had external evaluators come in and show us where improvements are needed.

We’ve ramped up relationship building with the broker community and community-based organizations. We’ve also worked to let the public know that MNsure is the place to shop and compare health insurance options.

We’ve done a good job turning the corner these past two years and the majority of Minnesotans are now enrolling through MNsure with relative ease, but we cannot hide from our history. The good news is we are improving every day.

What strategies helped you to exceed your enrollment goals for 2016?

MNsure is laser focused on helping consumers find a health insurance plan that fits their needs at a price they can afford. That means providing increased market transparency. At its core, MNsure really acts like a consumer protection agency, making sure Minnesotans are aware of all their health insurance options and the prices that go along with those options. In 2016, Minnesota saw large health insurance premium increases.

While we still have some of the lowest rates in the Midwest, the increases were a shock for many Minnesotans.

10

MINNESOTA HEALTH CARE NEWS APRIL 2016

What’s important to remember is that MNsure is the only place Minnesotans can access federal tax credits that can immediately lower those monthly premiums, or qualify for public programs. We do not want Minnesotans to leave money on the table. We’re encouraged that so many Minnesotans came to MNsure during this past open enrollment to compare plans and get financial help. In fact, 45 percent of MNsure’s current private plan enrollees are new for 2016. That’s the highest percentage of new enrollment nationwide. MNsure also saw the largest percentage of overall private enrollment growth nationwide.

These statistics tell us that more Minnesotans are getting the message about the benefits of MNsure, and that’s great news for Minnesota.

What are the most common misperceptions about MNsure? One of the biggest misperceptions about MNsure is that we’re an insurance company and we set health insurance rates. Both of those things are simply not true. MNsure is the marketplace you go to shop and compare health insurance products sold by private companies.

Think of MNsure as a grocery store and the private insurance companies as the aisles.

When Minnesotans come to MNsure they can walk up and down the aisles to check out insurance products from different companies, and see if they qualify for financial help while they’re at it.

MNsure enrolls consumers into health insurance coverage, but once that transaction is complete, the consumer is left with insurance coverage from a private insurance company.

Why aren’t the choices available through MNsure increased to include the leading national insurance providers? In order to sell health insurance products in Minnesota, an insurance company must meet very specific requirements that are regulated by the Minnesota Department of Commerce. The fact is that MNsure does not limit who can participate in the exchange and who cannot. If an insurance company is currently not participating in MNsure would like to do so, they are more than welcome to go through the process of having products on the exchange, as long as they follow the state and federal laws that are required.

What can you tell us about the way MinnesotaCare affects MNsure? MinnesotaCare is a public program that covers certain individuals who make too much money to qualify for Medical Assistance, but not enough to afford a private health

insurance plan. Minnesota is one of only two states in the country to offer a program like this on the exchange. MinnesotaCare offers great coverage, and we are happy that Minnesotans are getting coverage they need at a price they can afford.

What kind of data can you share about the savings MNsure members receive through Affordable Care Act subsidies?

Last year, Minnesotans saved nearly $50 million on their private health insurance premiums through tax credits available on MNsure. That’s up from $30 million in 2014. This is real money that Minnesota families can keep in their pockets each month.

These tax credits act like instant discounts off monthly health insurance premiums, which means Minnesotans see the benefit immediately and do not have to wait until tax time to collect.

What do you see in the future for MNsure? The Affordable Care Act is working in Minnesota. We just successfully completed our third open enrollment period and saw the largest percentage of enrollment growth nationwide. Additionally, a bipartisan task force created by the Minnesota State Legislature has recommended that Minnesota stay the course with a state-based marketplace. The Minnesota Department of Health also recently announced that since 2013, Minnesota’s uninsured rate has been cut in half and is now the lowest it has ever been in state history. People are getting into coverage, they are saving money through MNsure, and they are getting the level of coverage they need.

MNsure is the only place Minnesotans can access federal tax credits.

Under what circumstances could someone purchase insurance through MNsure outside of the open enrollment period? Just like when you want to make changes to your health insurance policy through an employer, MNsure allows enrollment changes if qualifying life events occur. These usually involve the loss of a job, marriage, birth of a child, or change in income. We require Minnesotans to verify that they are eligible for a special enrollment period. Minnesotans who are eligible for Medical Assistance or MinnesotaCare can enroll at any time during the year. There is no open enrollment for those two public programs.

I am encouraged by that news, but know there is still more work to be done. We are currently evaluating many of our operations and business practices, as well as identifying areas for IT improvement.

Much progress has been made since the initial rollout and the proof of that is starting to show.

What would you like patients to know about MNsure?

If you purchase health insurance coverage on your own, MNsure is the place to shop, compare, and get financial help like tax credits, low-cost, or no-cost plans. Visit us online, or in person, to find out what you might qualify for. The coverage you get through MNsure is no different than the coverage you purchase directly from an insurance company. In fact, it literally pays to shop on MNsure because you may find a better policy at a better price.

Don’t let addiction ruin your life.

Please call for help.

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APRIL 2016 MINNESOTA HEALTH CARE NEWS

11

BEHAVIORAL HEALTH

Positive psychiatry A new approach

By Dilip V. Jeste, MD

M

edical practice has traditionally focused on determining the causes of illnesses, developing and using safe and effective treatments, and reducing the associated suffering and disability. These components are not sufficient, however, to fulfill the enormous potential of medicine to promote human welfare.

The World Health Organization defines health, not as an absence of disease or infirmity, but as a state of complete physical, mental, and social well-being. Research shows that positive psychosocial characteristics such as resilience, optimism, and social engagement are associated with better health outcomes and longer lifespans.

The time has come to integrate positive mental health into medical practice, and to expand medical care to encompass the full spectrum of psychosocial functioning.

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V Gynecologic care, including well-woman screenings and in-office procedures.

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12

MINNESOTA HEALTH CARE NEWS APRIL 2016

What is positive psychiatry?

Positive psychiatry is the science and practice of psychiatry that seeks to understand and promote well-being by enhancing behavioral and mental wellness. The main objective is greater well-being, which for some patients may mean bolstering positive psychological factors such as resilience and social support. Positive psychiatry, with its focus on positive behavior modification, is not restricted to mentally ill people but is an approach applicable to all of medicine.

Historically, the concepts of positive psychiatry date back at least to 1906 when William James, a physician and psychologist, argued for a new approach to study and apply psychological principles underlying the success of the so-called “mind-cure,” which referred to the purported healing powers of positive emotions and beliefs.

However, positive psychiatry traces its most important lineage to the positive psychology movement pioneered by Martin Seligman and colleagues in the late 1990s.

Positive psychological states Positive mental health outcomes include: • Well-being, which is not an absence of disease, but the presence of positive psychological states such as life-satisfaction and happiness • Low level of perceived stress (the degree to which an individual believes that his/her contemporary demands or challenges exceed his/her ability to cope) • Post-traumatic growth (the opposite of post-traumatic stress disorder or PTSD), manifested by personality growth in the form of greater appreciation of life, changed priorities, greater sense of personal strength, and recognition of new possibilities for one’s life • Prevention of illnesses such as post-partum psychosis, poststroke depression, PTSD, and even dementia

Positive psychosocial characteristics Several positive traits can increase longevity, with effects rivaling or exceeding those of health risk factors such as smoking, hypertension, and obesity. Resilience and optimism in the face of illness or adversity, for example, are associated with better physical health, cardiovascular outcomes, physiological markers (including immune function), health-related quality of life, self-care, treatment and exercise adherence, and reduced mortality. Personal mastery—defined as expectations of personal effectiveness in achieving desired outcomes—promotes specific, adaptive, goal-oriented behaviors, despite ongoing stresses. Social engagement refers to how well integrated a person is into a social network, including the number and quality of close relationships, frequency of socialization, and the degree to which one finds pleasure from social integration/interactions.

unavoidable shrinkage of the brain. Yet research findings during the past 20 years have shown that brain growth and development continue into old age. Interestingly, such a positive outcome is related, not so much to the genes we inherit from our parents, but to our own behavior, attitude, and environment. Older individuals who keep their bodies and brains active are happier and more productive than are those who do not. How can an aging brain improve its function and structure? One mechanism relates to “compensation,” which involves increased recruitment and more efficient utilization of brain networks. Even more interesting, new synapses and, in some instances, new neurons form in older brains if stimulated by living in an enriched environment.

Brain growth and development continue into old age.

Spirituality refers to the degree to which one’s personal beliefs, thoughts, and behaviors focus on transcendent topics such as the meaning of life and belief in a higher being. It has been found to be associated with greater well-being as well as better health outcomes. Wisdom includes pro-social behaviors (compassion, empathy, altruism), social decision-making, insight, decisiveness, acknowledgement of uncertainty, emotional regulation, tolerance of divergent value systems, openness to new experience, spirituality, and a sense of humor.

Greater wisdom may be important for an older adult’s ability to survive and even thrive in spite of worsening physical health. Similarly, wisdom transmitted from older to younger generations may help to neutralize the loss of fertility in old age—the so-called Grandma hypothesis.

Positive environmental factors include family support, social support (the degree to which other people are available for emotional and physical support), availability of regular medical care; opportunities for physical, cognitive, and social activities; and provision of adequate nutrition. These factors are associated with reduced depression, anxiety, substance use disorders, hypertension, cardiovascular disease, and dementia, as well as longer survival. Finally, city planning, transportation, and community environment have also been shown to affect mental and physical health.

Successful aging Traditional definitions of successful aging have emphasized the absence of physical and cognitive disabilities. Recent studies, including some we have done at the University of California, San Diego’s Stein Institute for Research on Aging, suggest that for older adults, subjective quality of life is very important. There is a paradox of aging—whereas physical health declines with age, there is greater happiness, better mental health, and better management of interpersonal relationships. New learning is possible in later life, and older adults continue to exhibit new forms of adaptive capacity. That is successful aging.

Incorporating positive psychiatry Practice healthy lifestyles. For example, exercise is effective for improving physical health, reducing depression, and enhancing cognitive functions. Meditative practices such as tai chi, yoga, qigong, and mindfulness meditation have potential benefits across a range of psychiatric and physical diseases.

A healthy diet may reduce the risk of severe depression, while junk food, sugar, and processed meats may increase depressive Positive psychiatry to page 34

I

belong HERE.

MAKE A REFERRAL 952.548.8700 l www.stdavidscenter.org Early Childhood Education • Autism Services Pediatric Speech, Music and Occupational Therapy Children’s Mental Health • Special Needs Support Services

When I went to medical school, I was taught that most of the growth and development of the brain occurred early in life and that after 60 years of age, it was a downhill course with progressive and APRIL 2016 MINNESOTA HEALTH CARE NEWS

13

CHRONIC DISEASE

Rheumatoid arthritis Treatment and relief from joint pain

By Zaki Abou Zahr, MD, RhMSUS

R

heumatoid arthritis (RA), the most common form of autoimmune arthritis, is a chronic, long-term disease that may span a lifetime. It most commonly produces pain and swelling in the wrist and in the knuckles and middle joints of fingers, but any other joint in the body can also be involved.

Unlike the wear and tear symptoms of osteoarthritis (OA) that come with age, rheumatoid arthritis targets the lining surrounding your joints, known as the synovium. As with other autoimmune diseases, your body’s own defense system functions improperly and attacks healthy tissues—in this case, the synovium—triggering inflammation, producing RA symptoms, and, eventually, damaging the cartilage and bone within the joint.

SUNFLOWER SPREAD

With the exception of the upper neck bones, the spine is unaffected. RA mostly affects the joints, but inflammation can occasionally involve other organs, such as the eyes and lungs.

Risk factors RA affects 1.5 million American adults—nearly 1 percent of the nation’s population. It usually starts after the age of 40, but can occur at any age. Women are affected with RA three times more often than men, and the prevalence of RA increases to 5 percent among women 55 and older.

While the exact cause of RA has not yet been discovered, there is a genetic component that makes individuals more prone to develop the disease. It runs in families, with both siblings and offspring at an increased risk, but not every individual in the family will get it.

Smoking is associated with increased risk of RA. Symptoms Joint symptoms in RA start with inflammation that thickens the synovium, causing swelling, stiffness, pain, and limited joint motion.

The affected joints are usually symmetrical, meaning that if one hand or ankle is involved, the other side is too.

The stiffness seen in active RA is at its worst in the morning. It may last a few hours, or it may linger all day. For most patients, the stiffness loosens as the day goes by and also with movement. Stiffness can also occur after a long rest, in what is called a gel phenomenon. OA, by contrast, does not cause prolonged morning stiffness.

Swollen joints often become warm and tender as well, again improving during the day with movement. (In OA, such activity heightens pain). The swelling in RA is more of a puffiness in the joint, compared to OA’s bony prominence. Firm lumps, known as rheumatoid nodules, can develop under the skin—not in the joint— near the elbows and hands. Other variably occurring RA symptoms include fatigue, fevers, dry mouth, dry eyes, and anemia.

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MINNESOTA HEALTH CARE NEWS APRIL 2016

The course of RA ranges from mild to severe. The disease state can fluctuate from mild or no activity to flares or increased activity.

This is often related to factors affecting immune system activity.

These changes can happen despite treatment. It is important to report persistent changes to your rheumatologist, who may recommend a change of treatment regimen. The rheumatologist will perform specific exams, coupled with labs, X-rays, and ultrasound results, to develop a better picture of how the disease is progressing or improving.

Treatment options Treatment for RA has advanced greatly over the last 30 years, providing new hope and relief for patients. While there is no cure for RA, treatment can control the symptoms significantly or keep them dormant for a long time. People who get early treatment feel better sooner and have better long-term disease management. Early treatment also delays joint damage and reduces its likelihood. This is because joint damage starts within the first two years of disease onset. Early treatment also reduces the possibility of future joint replacement surgery.

The goal of treatment is to calm the inflammation, thereby decreasing swelling and stiffness and relieving pain. If joint damage is present or cannot be prevented, the goal is to slow it down or stop it. The ultimate aim is to preserve functionality and quality of life and to reduce mortality. If left untreated, RA patients have increased mortality.

taking them alone. As with DMARDs, biologics require frequent visits to the rheumatologist to check response, blood test results, and side effects.

Living with rheumatoid arthritis It is important to stay active if you have RA. When the disease is under good control, it is recommended to do aerobic exercise, which will improve muscle strength and decrease pressure on the joints. Exercise can also strengthen bones that may have been thinned with steroids and lack of activity. When the disease is in flare, the intensity of exercise should be reduced to focus more on stretching exercises to maintain range of motion, along with rest.

Treatment for RA has advanced greatly over the last 30 years.

Current treatments produce excellent relief and near-normal functionality in most patients. This is often termed a state of “remission,� in which no signs of active disease are present. To achieve this, a certain regimen of medications needs to be tailored to each individual patient with RA. No single medication works for all.

There is a backbone of medications for nearly all cases of RA named Disease Modifying Anti-Rheumatic Drugs (DMARDs). As the term implies, these modify the disease course and slow progression by reducing inflammation and bone erosion. DMARDs take a few months to achieve their full effect. During that time, inflammation and stiffness may be reduced with corticosteroids such as prednisone and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, meloxicam, and others.

Consultation with a physical or occupational therapist may be necessary to identify which activities are best and at what level they should be performed. Some patients find that taking a warm bath in the morning, or soaking their hands in warm water, will reduce morning stiffness.

RA is a chronic illness and a life-changing event. However, there are now many more available treatments. Always include your rheumatologist in your decisions to guide your way with this disease.

Zaki Abou Zahr, MD, RhMSUS, is an assistant professor of medicine at the University of Minnesota. He is board-certified in internal medicine, rheumatology, and musculoskeletal ultrasound. His clinic is at Hennepin County Medical Center.

Patients may feel relief with corticosteroids, but the long-term side effects under high doses of these drugs are serious enough to warrant lowering doses as soon as possible. A combination of DAMRDs is often needed to achieve remission if a patient is a partial responder to just one medicine. It is not unusual for a patient to fail a certain medication and need to switch classes, rather than just adding on to current medication. DMARDs require frequent visits to the rheumatologist to monitor response, blood test results, and side effects.

The most common DMARDs are brand name or generic versions of methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine. Physicians will tailor each individual case before prescribing, bearing in mind previous allergies, side effects, existing medical conditions, and pregnancy.

In instances of more serious disease or lack of optimal response to one or more DMARDs, a step-up category of medications is needed. These are called biologic agents. They can target specific signals in the immune system sequence that lead to inflammation. Most of these medications are either pre-filled injections self-administered at home or infusions given in an infusion center. Common biologics include brand name or generic variations of etanercept, adalimumab, infliximab, certolizumab, golimumab, abatacept, rituximab, tocilizumab, anakinra, and tofacitinib. These agents are most effective when combined with DMARDs such as methotrexate, rather than APRIL 2016 MINNESOTA HEALTH CARE NEWS

15

PULMONOLOGY

Asthma An Olympic athlete’s story

By Allan Stillerman, MD

O

n his sixth birthday, Michael was diagnosed with asthma and hospitalized for an “asthma exacerbation”— a clinical term for a severe asthma attack.

His journey had started three weeks into the new school year, with frequent nightly coughs that awakened the boy and his family but improved somewhat during the day. His family suspected it was just another one of his “viral bronchitis episodes”: over the years, his coughs had worsened as the snow melted and as he played in the fall leaves, but they always improved with snow cover. After a

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MINNESOTA HEALTH CARE NEWS APRIL 2016

hayride on his sixth birthday, he started wheezing, a condition that was aggravated by running around outside with his friends. As he became increasingly short of breath and had difficulty completing sentences, he was taken to the emergency department, where he was given frequent inhaled bronchodilators (medications that relax the bronchial muscles). Those offered only partial relief, and intravenous corticosteroids came next. Further treatment would require supplemental oxygen, so the young boy was hospitalized.

Fortunately, Michael eventually responded to the therapy, and was discharged two days later to the care of an allergist. He had missed two days of school with this episode and four days in the previous 12 months for respiratory illnesses.

A typical case This tale is all too familiar to many families. This chronic disease can strike at any age, but most often starts in childhood. The airways become inflamed and restricted, often causing wheezing and coughing, shortness of breath, increased mucus production, and tightness in the chest.

Asthma accounts for about 15 percent of non-surgical pediatric hospital admissions, making it the most common medical diagnosis among hospitalized children, according to Miles Weinberger, MD, professor of pediatrics at the University of Iowa Children’s Hospital.

“Asthma is also one of the leading causes for emergency care requirements, one of the leading causes for missed school, and a cause for considerable morbidity, disability, and occasional mortality at all ages,” he writes.

Michael benefited from both clinical research studies and strict adherence to a custom treatment plan, starting with an evaluation by a board-certified allergist at Allergy & Asthma Specialists, PA. Based on an ACT (Asthma Control Test) questionnaire score of 14/25—which indicated very poorly controlled asthma—Michael performed lung function tests, which revealed airflow at less than the normal range. Further evaluation and skin testing confirmed allergies to outdoor mold, which had and would continue to bother Michael in the months between snow melt and snow cover.

In establishing any asthma diagnosis, it is essential to categorize the severity, frequency, pattern, triggers, and control of the

patient’s asthma (see sidebar for control criteria). In Michael’s case, the diagnosis was confirmed and categorized as: “Asthma: severe persistent,” which was clearly “uncontrolled.” Michael’s triggering factors—outdoor mold allergy, cold air, exercise, viral infections (the third week after children return to school in September is noted for the highest annual recording of viral infections throughout the country), and smoke and fumes—were identified and discussed with the family.

A custom plan Michael’s family was counseled that his severe asthma could be—and should be—very well controlled.

They received education regarding the disease, Michael’s specific triggers and their management, and instructions on how to collaborate with the allergist to control his asthma and live a normal lifestyle. A customized action plan was developed and reviewed, then distributed to the family, pediatrician, and school.

or fractional exhaled nitric oxide) confirmed an increased level of exhaled nitric oxide, which reflected an increased allergic inflammation often seen with inadequate use of controller medications. Michael acknowledged discontinuing the inhaled steroid controller, and agreed to continue using it.

The teenage years Michael developed allergic rhinitis (hay fever) and sinusitis (sinus infection or inflammation) in his teens, attributable to outdoor mold, most notably in spring and fall. Medications did not help—in fact, nasal medications produced nose bleeds as a side effect.

He was started on allergy immunotherapy; after five years, he no longer experienced sinusitis and had his doses of asthma medications lowered.

He also participated in ongoing clinical research trials, such as those conducted by Clinical Research Institute, Inc., a dedicated clinical research site that conducts Phase II through IV pharmaceutical research studies. Volunteers work with physicians, monitors, pharmacists, lab specialists, and others to determine the safety and effectiveness of new medications, devices, products, and treatment regimens intended for human use. Such studies often lead to new ways to care for a disease or condition.

This chronic disease can strike at any age, but most often starts in childhood.

Michael was also given a rescue bronchodilator to relax bronchial spasm. He was advised to take this 20 minutes before continuous exercise, and as needed for coughing, wheezing, or shortness of breath. If he did not experience well-defined relief, his family was told to contact the allergist for further direction.

The plan also called for an annual influenza vaccine, to avoid smoke and fumes, and to attend regular outpatient follow-up visits to ensure good control.

By the time of his first follow-up visit two weeks later, Michael and his family were sleeping at night. While he had initially needed his rescue albuterol inhaler four times per day, he now needed it just twice per day. His technique of administration of medication was reviewed and corrected. Lung function was nearly normal. Although much improved, Michael’s asthma was still considered “uncontrolled,” as judged by his frequency of rescue inhaler use. A long-acting bronchodilator was added to his controller-inhaled steroid, and a two-month recheck was scheduled.

The following January, Michael’s ACT score was 22/25 (normal). He ran laps at school, preceding each run with albuterol. He outperformed his peers and astonished them and his coach. It was then clear to his family that he had been limiting his exercise on account of his previously undiagnosed asthma. His lung function was now better than average. Over time, the frequency and dosing of his controller medication was adjusted, according to the season and his wellbeing.

When he was 12 years old and self-administering his medications, Michael decided secretly to discontinue his controller. After doing so, he experienced a flare of his asthma. Lung tests (FeNO,

Asthma to page 19

Telephone Equipment Distribution (TED) Program

Under this plan, his parents were advised to administer inhaled corticosteroids as a prevention controller, using a metered dose inhaler (MDI). This was needed to control daily inflammation, even when Michael was well, and would require parental supervision, so the parents were trained in the correct technique.

Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability?

If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify.

Please contact us, or have your patients call directly, for more information.

1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services APRIL 2016 MINNESOTA HEALTH CARE NEWS

17

Calendar April-May 2016 Apr.19

Grief & Loss Support Group

The Aliveness Project hosts this free support group for people with HIV or their partners who have lost a loved one. Come gain support and learn new strategies on how to cope. Call Becca at (763) 253-2110 to sign up or learn about other meeting dates.

Tuesday, April 19, 1 – 2 p.m., The Aliveness Project, Community Rm., 3808 Nicollet Ave. S., Minneapolis

23

Transitioning from Pediatric to Adult Health Care

The Lupus Foundation of Minnesota hosts this free discussion for youth living with lupus and other autoimmune diseases to learn about the transition from pediatric to adult health care services. To register, call Sandy at (952) 746-5151 by April 22.

Saturday, April 23, 1 – 3:30 p.m., Hallie Q. Brown Community Center, Club Rm. C, 270 N. Kent St., St. Paul

29

Aphasia Communication Group

Allina Health offers this free weekly support group for people with aphasia to practice communicating. Led by Courage Kenny Rehabilitation Institute speech therapists.

No registration required; call Allison or Elise at (612) 775-2755 with any questions.

Friday, April 29, 10 – 11 a.m., Courage Kenny Rehabilitation Institute, 3915 Golden Valley Rd., Golden Valley

30

Rett Syndrome Education Day

Gillette Children’s Specialty Healthcare and the Midwest Rett Syndrome Foundation present this free day of learning and connection for families and caregivers of people living with Rett Syndrome. Come learn about drug and research updates, communication issues, and parenting tips. To RSVP, call Mary at (651) 578-5002 by April 22.

Saturday, April 30, 8 a.m. – 4 p.m., Hyatt Regency Bloomington, 3200 E. 81st St., Bloomington

Deaf Awareness Day About 1 million people over five years of age in the U.S. are considered functionally deaf, according to national government surveys. Hearing loss and deafness can be caused by genetics, complications during pregnancy, certain illnesses, some medications, tumors, head injuries, aging, and exposure to excessive noise.

How hearing loss affects a person depends on factors such as whether it was early or late onset, the progressive nature of the loss, the severity, and communication demands. In many cases, it has been linked to feelings of depression, isolation, anxiety, frustration, and fatigue. Seeking support with others experiencing deafness and learning alternative ways to communicate can help reduce the feeling of isolation.

Anyone suspecting hearing loss should seek care through a hearing health care professional as soon as possible. Early detection and intervention are important to minimize the impact of hearing loss, especially in children.

April 23

Deaf Awareness Day Event

The Minnesota Association of Deaf Citizens hosts this all-day event for individuals and families affected by deafness and anyone wanting to learn more about the deaf community. Come interact with the community, see product demonstrations, and meet professionals that specialize in hearing loss. Free; no registration required.

Saturday, April 23, 9 a.m.– 4 p.m., North High School, 2416 11th Ave., St. Paul

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406.

Email submissions to amarlow@mppub.com or fax them to (612) 728-8601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.

May 3

Health Care Directives

Hennepin County Library and Fairview Health Services offer this class for anyone wanting to learn more about advance care planning. Come learn how to complete or review your own health care directive. Registration not required; multiple times available.

To learn more, call (612) 543-8400.

Tuesday, May 3, 10 – 11:30 a.m., Walker Library, 2880 Hennepin Ave., Minneapolis

9

Life Planning for People with Disabilities

PACER Center offers this free information session for anyone who would like to learn about guardianship and conservationship laws, power of attorney, trust, and other life planning issues. A second session is offered on May 19 that will cover additional information. Call 952-838-9000 to register.

Monday, May 9, 6:30 – 8:30 p.m., PACER Center, 8161 Normandale Blvd., Minneapolis

11

Lymphedema Class

Park Nicollet hosts this free educational class for anyone at risk of developing lymphedema from surgical node removal, other surgical procedures, or radiation. Learn about the causes, signs, and symptoms of lymphedema and lifestyle practices to decrease your risk. Call (952) 993-5700 to register or for more information.

Wednesday, May 11, 12:30 – 1:30 p.m., Park Nicollet Frauenshuh Cancer Center, Ground Flr., Curtis and Arlene Carlson Family Community Rm., 3931 Louisiana Ave. S., St. Louis Park

23

Yoga for Chronic Pain

Tula Yoga & Wellness hosts this SomaYoga for Chronic Pain class. Come begin to undo years of chronic tension and pain and gain strength and stability to increase your quality of life. Classes are drop-in, no registration required. Minimum donation of $5 requested. For more information, call (651) 645-5551.

Monday, May 23, 7:30 – 8:45 p.m., Tula Yoga & Wellness, 99 Snelling Ave. N., St. Paul

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MINNESOTA HEALTH CARE NEWS APRIL 2016

Asthma from page 17

Criteria for control of asthma

As a teen, Michael participated in two FDA (U.S. Food and Drug Administration) clinical research asthma trials evaluating new inhaler devices and medications, which were later approved by the FDA as safe and effective. Michael learned to evaluate and report his asthma control under this regimen, as did his sibling. He was particularly proud that he had contributed to the development of a “cool new asthma device.”

Asthma accounts for about 15 percent of non-surgical pediatric hospital admissions.

Today Michael never experienced further emergency department visits or hospitalizations. He visited his allergist twice per year, had perfect school attendance, and grew to 6’2”—the tallest in his family. He competed successfully at track and field events throughout high school and college and competed in the Olympic games at 21, winning a silver medal.

The keys to these golden opportunities were expert allergist care, prior clinical research results, and contributions to ongoing clinical research.

Don’t Suffer Alone

• Absence of hospitalization • Absence of unscheduled medical care • Absence of interference with sleep or activities (including competitive athletics) • Infrequent (less than three times per week) intervention with inhaled rescue agonist (not counting pre-exercise use) • Infrequent intervention with short courses of high-dose daily oral corticosteroids (less than four times yearly ideally, although some young children may have viral respiratory-induced exacerbations more frequently for an occasional year, for which there is no good alternative to an oral corticosteroid) • Normal or best attainable post-bronchodilator pulmonary function by office spirometry (a common pulmonary function test) • Absence of adverse medication effects • Absence of effects of asthma or its treatment on quality of life — Miles Weinberger, MD, University of Iowa Children’s Hospital

Allan Stillerman, MD, is board-certified by the American Board of Allergy and Immunology and the American Board of Pediatrics. He conducts clinical research in the fields of asthma, food allergy, and allergic rhino conjunctivitis.

He practices with Allergy & Asthma Specialists, P.A.

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Gambling addicts don’t need to suffer alone. A full life can be restored with treatment and support.

Call 1-800-333-HOPE • Or visit www.NorthstarProblemGambling.org APRIL 2016 MINNESOTA HEALTH CARE NEWS

19

OPHTHALMOLOGY

Causes and remedies

By Tina McCarty, OD, FAAO

I

nflammation of the eye’s protective lining—what eye doctors call conjunctivitis and what most people know simply as “pink eye”— can cause significant discomfort and inconvenience, but long-term complications are rare. It’s important to treat conjunctivitis promptly, though, to reduce the risk of recurrence or of spreading infection.

Terms The conjunctiva is a thin lining covering both the white part of the eye (the sclera) and the inner eyelid. The “bulbar” conjunctiva (covering the outer surface of the eye) and the “palpebral” conjunctiva (lining the inside of the eyelids) meet in a junction called the “fornix.”

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MINNESOTA HEALTH CARE NEWS APRIL 2016

The conjunctiva lubricates the eye and protects the underlying structures from environmental threats. When the conjunctiva becomes irritated, infected, or injured, the blood vessels dilate, the tissue becomes inflamed, and conjunctivitis develops. This inflammation is classified into several categories based on cause, each of which is characterized by different symptoms and different treatment alternatives.

Causes and classifications Many different infections, irritants, and environmental factors can lead to conjunctivitis, which may be classified as: Bacterial. Many kinds of bacteria—spread by hand-to-eye contact, sharing of a pillow or towel with an infected individual, exposure to infected airborne droplets, or contact with adjacent infected nasal or sinus tissue—can produce bacterial conjunctivitis.

In addition to the red and inflamed eye, one of the hallmarks of bacterial conjunctivitis is a thick discharge containing mucus and pus, often yellow or green in color. Other symptoms can include mattering of the eyelashes (especially after sleeping), burning eyes, blurred vision, and sensitivity to light. Although bacterial conjunctivitis can occur at any age, it is most common in young children. Bacterial conjunctivitis typically is treated with a 7–10 day course of topical antibiotics to limit the duration of the infection, thereby limiting the spread to other individuals.

Viral. Caused by a virus that is usually associated with a concurrent infection of the upper respiratory tract or the common cold, viral conjunctivitis is also very contagious and can be spread in much the same manner as bacterial conjunctivitis. Viral conjunctivitis often has more watery discharge and redness. Other symptoms could include swelling, burning, foreign-body sensation, crusting of the lashes, sensitivity to light, and blurred vision. It can even produce small hemorrhages on the surface of the conjunctiva. Viral conjunctivitis typically is difficult to treat and often needs to run its course. In some instances topical medications may be used to prevent a co-existing infection or to aid in reducing the inflammation, especially if vision is blurry or the patient is uncomfortable.

Allergic (from environmental allergens). This is most commonly related to hay fever, but can also be from sources such as pollen, dust, pet dander, mold, cosmetics, or products used on or near the eye. This also produces a red and irritated eye with watery

discharge, but the hallmark complaint is typically itching. Other signs can be burning, swollen eyelids, and fluid retention (edema) under the bulbar conjunctiva, producing significant swelling.

Treatment can be in the form of different anti-allergy eye drops such as topical antihistamine to control the itching, mast cell stabilizer medications to lessen the release of histamine, or a combination antihistamine/mast-cell stabilizer in the same drop.

In some cases a steroid is utilized to gain control of the inflammation first or concurrent with the anti-allergy medication to help it begin to work quicker. I have trained my patients with predictable seasonal allergies to begin taking anti-allergy eye drops 7–10 days before they expect the allergies to be an issue.

This allows the drop to begin working so it can be at maximum effect when the allergies are at their worst, rather than having to wait a week before the medicine takes its full effect.

• Water and contact lenses do not mix.

• Replace your contact lenses as prescribed by your eye doctor.

• Clean your contact lenses as prescribed by your eye doctor.

• Try to begin treatment for seasonal allergies before they start.

• See your eye doctor for proper diagnosis and treatment to lessen severity and duration of the problem.

Take care Fortunately there are typically no long-term complications associated with conjunctivitis. I would like to summarize by stating that it isn’t normal to have a red eye; if your eye is inflamed, your body is trying to tell you that something isn’t right and that it requires attention. I often see patients in my office that are “silent sufferers,” who have put up with a persistent red or pink eye as their new normal. Perhaps they have gone to the pharmacy in search of an over-the-counter remedy, only to find that it isn’t the right product for them. Or the product may have a redness reliever in it that makes the condition harder to diagnosis or that creates a tolerance, requiring increased applications to achieve the same effect or causing increased redness in the long run. A red eye is an issue to be diagnosed and treated appropriately by your eye doctor to enable quick resolution and lessen the chance of recurrence.

It isn’t normal to have a red eye.

Allergic (from contact lenses). Patients who wear contact lenses too long or whose lenses have accumulated deposits may develop Giant Papillary Conjunctivitis (GPC). The visible part of the eye typically appears normal, but inverting the eyelids reveals a very impressive swelling of the palpebral conjunctiva. In the case of GPC, patients actually become allergic to their own protein or lipid deposits on the surface of their reusable contact lenses. If a reusable contact lens isn’t cleaned properly or is worn beyond its expected lifecycle, or if the patient has excessive oil or mucin in their tears, a deposit builds up on the lens surface. Over the course of several thousand daily blinks over this deposited surface, the patient can develop a palpebral conjunctivitis. Their contact lenses may become uncomfortable, wear out more quickly, or produce blurry vision associated with looking through the deposited surface. GPC can also result from a contact lens that fits too loosely or that contains a material that isn’t tolerated by the patient. Treatment for GPC usually involves discontinuing contact lens wear until the inflammation has resolved and/or the use of topical steroids to treat the inflammation.

Once the inflammation is resolved the patient can be re-fit into a different type of contact lens made of a different material, with a different fit, or, best yet, a single use option where the lens is only worn once and then discarded. Fortunately, as single use contact lenses have become more common-place, we have seen less GPC in our offices.

Conjunctivitis after injury. As the conjunctiva is the outmost layer covering the delicate surface of the eye, it can be injured through a scratch or abrasion, causing inflammation and therefore conjunctivitis. Depending on the severity of the injury, lubrication in the form of artificial tears, gels, or ointments can help to soothe the surface and aid in the quick regeneration of superficial cells.

Prevention Follow these common-sense tips to reduce your risk of developing or spreading conjunctivitis:

Tina McCarty, OD, FAAO, is a partner at the Eye Care Center in Maple Grove, Fridley, and Maplewood.

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• Never share your contact lenses with others.

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21

TAKE CARE

Brain health Maintaining proper function

By Scott Hoppe, DC

A

mid all the focus on healthy lifestyles and positive steps we can take to minimize our risk of disease, we often overlook one organ: the brain. By following a healthy diet and changing some basic behaviors, you can help to ensure that this vital organ remains healthy, while also boosting your overall well-being.

Think right. Omega-3 fats (high DHA), B-vitamins (methylated), and magnesium all help to create a healthy functional brain, whereas stress, toxins, and poor food choices can damage or even destroy neurons. In addition to diet, try learning a new skill, starting a new hobby, and surrounding yourself with positive people.

Healthy body, healthy brain Researchers continue to learn more about the brain’s unique needs, but many agree that the same common-sense behaviors that promote good health will also help our brains to function at their peak.

Among those recommendations are the “the Magnificent 7,” as identified by Robert A. Rakowski, DC:

Eat right. Strive for nine or more servings of fruits and/or vegetables each day to help alkalize your system, improve energy and efficiency, and help prevent chronic disease. Eat whole foods and healthy fats, and limit processed foods. A brain-friendly diet also includes leafy green vegetables, seafood, eggs, olive oil, nuts, avocados, colorful fruits, and lean meats.

While eating these “right” foods, you should eliminate foods that upset your system, paying particular attention to gluten, dairy, and other food intolerances that may weaken your immune system.

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Maintaining stable blood sugar is also vital, since surges in blood sugar and insulin are devastating to brain health. Eliminate sugar, processed starchy foods, and junk foods, all of which can lead to pre-diabetes and type 2 diabetes and put you at higher risk for dementia and Alzheimer’s disease. In fact, some researchers now refer to Alzheimer’s disease as “type 3 diabetes,” citing research associating it with both type 1 and type 2 diabetes.

Drink right. Pure water cleanses the body and primes our biological processes. To determine the ideal daily intake of water, divide your body weight by two and drink that many ounces of good filtered water. Add 4 ounces for every 15 minutes of intense exercise.

Focus on water, tea, and healthy coffee, and avoid sugary drinks.

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Move right. Research shows that 30 minutes of daily exercise can help you feel better and live longer. Exercise has been documented to improve brain health and reduce the risk of Alzheimer’s disease by many mechanisms, but primarily by increased blood flow.

Consider meditation as well: it’s great for improving concentration and attention, and it rivals antidepressants for reducing depression and anxiety.

Talk right. Positive speech has a positive effect on you and those around you. Stay connected with friends and continue to be social.

Keep a journal of all the positive things that happen each day.

22

MINNESOTA HEALTH CARE NEWS APRIL 2016

Eliminate right. Your body eliminates toxins in a timely manner, with food passing within an 18–22 hour digestive cycle. The National Institutes of Health cites studies linking the emotional and cognitive centers of the brain with healthy intestinal functions,

stressing the role of useful microrganisms in your digestive system.

In simpler terms, by improving your digestive health, you can improve your brain health, under this “gut-brain axis.”

Sleep right. A good night’s sleep is vital to all aspects of health, and will help keep your brain working well. Poor sleep makes fat cells less sensitive to insulin, the hormone that brings glucose into cells so they can produce energy—in effect, making a person more insulin resistant or pre-diabetic.

In addition to promoting overall health, the Magnificent 7 can also help to keep your immune system functioning well and to control inflammation—the body’s natural response to injury and infection. In addition to redness, swelling, and tenderness, inflammation can also leave our brains feeling “down” or confused.

A weakened immune system may also place you at higher risk for inflammations of the brain itself.

Many patients are not aware of the role of chiropractors in concussion recovery.

Concussion and chiropractic Contact sports, slip and falls, and motor vehicle accidents send many to the emergency department to be checked for possible concussion and traumatic brain injury.

Surprisingly, some individuals with less dramatic injuries—perhaps a simple bang on the head—are not even aware that they have suffered a brain injury. They might discount common symptoms of concussion (poor balance and coordination, headaches, poor memory, slowed reaction time, nausea, fatigue, and more) for some time, seeking a health care professional only when these symptoms persist.

Treatment may include neurological tests, imaging scans, rest, and followup visits with a primary physician or neurologist, but I’d like to highlight another component that many patients are not aware of: the role of chiropractors in concussion recovery.

The ability to sense position, motion, and equilibrium—proprioception—can be disrupted following brain injury, hindering the brain’s ability to receive appropriate information. Chiropractic procedures can actually retrain parts of the brain to address these concerns.

By activating descending vestibular systems (which involve balance and equilibrium), activating core muscle control, and reactivating tone, it is possible to improve proprioceptive integration. However, concussion recovery requires much more than chiropractic adjusting.

It is best to find a chiropractor or practitioner specially trained to diagnose and treat complex brain injuries. A comprehensive care plan might include: • A chiropractic neurological exam • Testing of the inner ear and motor functions (Videonystagmography) • Measurements of rapid eye movements using a saccadometer • Tests of dizziness using platform posturography • Visual motor and neuro-cognitive training using Dynavision D2 • Comprehensive blood chemistry tests

A thorough chiropractic exam—often following referrals from neurologists, orthopedists, and coaches—helps to treat the root cause of the condition, not just the symptoms, and speed recovery.

A typical course of treatment might include 12 sessions, although individual cases could warrant shorter or longer rounds. In addition to the treatments listed above, patients might also expect chiropractic adjustments, active range-of-motion exercises (ARPWAve Neuro Therapy), cognitive and motor skills exercises (Interactive Metronome), headache protocols, and autonomic/limbic stability training.

Chiropractors are also trained to identify concussion symptoms in the course of routine exams.

Conclusion The factors that support brain health—from day to day and in the event of injury—are the same as those that support your overall body health. The key is to follow simple strategies to create change in multiple areas. Control your stress, fight inflammation, stay active, and follow a whole food diet rich in antioxidants and omega fats. If you are able to follow the Magnificent 7, you will keep your brain, the director of your symphony of life, on rhythm, and the rest of your body healthy.

Scott Hoppe, DC, is a Twin Cities-based chiropractor. His special interests and studies include functional medicine, functional neurology, applied kinesiology, chiropractic care, and enhancing performance.

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23

CARDIOLOGY

HYPERTENSION The “silent killer”

By Thomas Knickelbine, MD, FACC, and Gretchen Benson, RDN, CDE

H

ypertension (or high blood pressure) is a common condition that affects about one in three Americans over the age of 20. Hypertension is often referred to as the “silent killer” because it usually doesn’t have any warning signs or symptoms. That’s why it’s important to have your blood pressure checked at every clinic visit.

Understanding the numbers Blood pressure is measured as pressure in millimeters of mercury (mmHg) and includes two numbers. The top number (systolic) is the pressure in the blood vessels when the heart beats to pump blood.

The bottom number (diastolic) is the pressure when the heart rests between beats. Optimal blood pressure is 120/80 mmHg or lower.

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Hypertension (generally considered high when systolic is 140 or greater or diastolic is 90 or greater) happens when blood moves through your blood vessels with too much pressure, causing stress on organs including the brain, heart, blood vessels, and kidneys. Hypertension can be underdiagnosed and not properly treated. Data from the most recent National Health and Nutrition Examination Survey revealed that among U.S. adults with hypertension, only 52 percent were properly controlled, while 17 percent were undiagnosed.

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If left untreated, high blood pressure can cause significant damage to your heart and arteries, increasing your risk of atherosclerosis (buildup of plaque or fatty substances along artery walls), heart attack, stroke, and congestive heart failure. For people with diabetes, hypertension can also increase the risk of eye, kidney, and nerve damage.

A single high reading does not necessarily mean you have hypertension. Some people have what is referred to as “white coat” hypertension—when blood pressure is elevated only at the office visit and is otherwise normal. Your health care provider may monitor your blood pressure over the course of several visits—or have you monitor your blood pressure at home before diagnosing you. A 24-hour blood pressure test can sometimes be helpful in making a proper diagnosis.

Lifestyle Blood pressure will increase for most people as they get older, due to stiffening of the blood vessels with age. Other risk factors for high blood pressure include: family history; race; and several lifestyle factors, including lack of physical activity, poor eating habits (especially eating many packaged/processed, sodium-heavy foods), excessive alcohol consumption, and being overweight.

Lifestyle can play a major role in preventing high blood pressure—and in managing it if you already have it. Studies show that eating nutritious foods and reducing sodium can help reduce blood pressure—in some people, as effectively as a single blood pressure medication. Your body weight also plays an important role; in some cases, simply reducing weight can help avoid the need for blood pressure medications.

There are several eating patterns that can reduce blood pressure. Two of the best known: DASH (Dietary Approaches to Stop Hypertension), first introduced in the late 1990s, remains one of the best diets for a healthy heart and reduced blood pressure. The DASH diet incorporates a lot of fruits and vegetables: 4–5 servings of each, plus 6–8 servings of grains (preferably whole), 2–3 servings of low-fat dairy, 6 (or fewer) ounces of lean meat, poultry, or fish each day, and 4–5 ounces of nuts, seeds, and legumes each week (for more information, see: www. nhlbi.nih.gov/files/docs/public/heart/dash_ brief.pdf).

Medical treatment Lifestyle alone may not be enough to lower blood pressure. Medical treatment should be individualized and is based on several factors, including age and medical history. Generally, for people 60 years or younger (and people of any age with diabetes), treatment should start when blood pressure is 140/90 or higher. For those over 60, treatment should start when blood pressure is 150/90 or higher.

A recent study on optimal goals for blood pressure showed surprising results.

The Systolic Blood Pressure Intervention Trial (SPRINT), funded by the National Institutes of Health, showed that participants who were assigned to achieve a systolic goal of less than 120 significantly lowered their risk of heart-related events, such as a heart attack, compared to a group whose systolic goal was less than 140.

While this may change the future goals of blood pressure management, this trial has not yet altered the current recommendations from the American Heart Association.

A single high reading does not necessarily mean you have hypertension.

The Mediterranean diet has received much attention lately for its positive impact on heart health, including blood pressure. It’s known for its generous amount of fruits and vegetables, in addition to a higher amount of overall fat—predominantly healthy, unsaturated fat.

The DASH and Mediterranean diets share many common characteristics, including plenty of fruits, vegetables, and whole grains, non-tropical vegetable oils and nuts, and limited intake of sweets, sugar-sweetened beverages, and red meats.

When combined with the DASH diet, reducing sodium can produce immediate improvements to your blood pressure. The American Heart Association and the American College of Cardiology encourage people to limit their sodium intake to 2,400 milligrams (mg) or less per day. If you keep your sodium at or below this goal (about one teaspoon of salt), you could drop your systolic number by 8 mmHg, which is similar to the blood pressure drop you would experience with medication. Even if you aren’t able to achieve the goal of 2,400 mg a day, reducing your sodium by 1,000 mg has been associated with a 30 percent reduction in cardiovascular events.

Many people don’t know that salt is actually an acquired taste.

We’re not born craving foods with salt—we learn to want it after years of eating salty foods. Most of the salt we eat comes from canned or processed foods, so familiarizing yourself with food labels is an important strategy. This allows you to compare foods and select lower-sodium versions. Many of the top sources of sodium in American diets come from foods that don’t even taste salty, like pizza, burgers, bread, cheese, and pasta dishes. It’s important to remember that many condiments, such as ketchup, have salt too. Gradually making changes to your diet allows you to start enjoying the natural taste of foods. Balancing your meals with naturally low-sodium options, like fresh fruits and vegetables, is also important.

Medications—which vary for each patient—work in a variety of ways to reduce blood pressure. Current medications include: 1) ACE Hypertension to page 29

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ELDER CARE

Addressing “food insecurity”

By Nancy Christianson

D

ean’s one-bedroom apartment is neat as a pin. The 78-yearold, who has lived in a Minneapolis Public Housing Authority (MPHA) complex for more than a third of his life, enjoys the security of his favorite easy chair and a comforter with an illustration of a golden retriever on it. Dean, who has an intellectual disability, walks frequently and takes care of himself with the help of a long-time counselor and a network of social contacts.

One other area of his life is secure. Unlike many older adults with low incomes, Dean enjoys a well-balanced daily meal, in his case delivered weekdays to a communal dining center by Volunteers of America–Minnesota (VOA–MN)’s Senior Nutrition service. More

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MINNESOTA HEALTH CARE NEWS APRIL 2016

than 4,000 older adults participate in the program, at 28 locations in Hennepin and Anoka counties. In addition to healthy meals prepared in consultation with a certified nutritionist, the VOA-MN Senior Nutrition service also provides vital social interaction with other seniors.

Changing needs A healthy diet is important at any age, but many older adults find it increasingly hard to eat well. As we age, our metabolism slows down. We may require fewer calories—and our appetites may diminish—but our systems still demand the same basic nutrients. In fact, eating less should mean focusing more on nutrient-rich foods, including fruits and vegetables, whole grains, nuts, fish, dairy, and lean meats.

But even seniors who are fortunate enough to have these choices may not eat healthy meals. They may not be hungry, may eat portions that are too small, or may focus just on the foods they enjoy most. An aging palate may also perceive foods to be too sour, too sweet, or too bland, causing seniors to load up on salt or to eat smaller portions.

They may also be unaware of changing nutritional concerns.

Needs vary by individual, but many older adults require different levels of vitamins and nutrients, as well as different levels of calcium.

In an ideal world, all seniors would discuss their nutritional needs regularly with a physician, but not all older adults do so.

For many older adults, a visit to the doctor coincides with a trip to the emergency department or an extended care facility. Their discharge papers may include detailed dietary instructions, but because of stress, personal concerns, confusion, or general health, they may fail to follow through.

Of course, many also face practical barriers. They may not be able to get to the store themselves or have access to delivery services—or they may live in an area where it is unsafe to venture outside. They may have physical limitations preventing them from cooking themselves. They may suffer from depression, or lack the motivation to take care of their food needs. Or they may simply be unable to afford healthy foods.

By the numbers Poor nutrition, known as “food insecurity,” often results from cutting corners with food—which in turn leads to a host of health

problems. A recent Spotlight on Senior Health study, commissioned by the National Foundation to End Senior Hunger, illustrated the implications of food insecurity among those 60 and older:

a healthy lifestyle. The increase in senior food insecurity is particularly concerning given the growing proportion of the population that is comprised of seniors.”

• 60 percent are more likely to experience depression.

In 2040 there will be 79.7 million older adults, more than twice as many as in 2000. The number of food insecure seniors is projected to increase by 50 percent, when the youngest of the Baby Boom generation reaches age 60 in 2025.

• 53 percent are more likely to report a heart attack.

• 52 percent are more likely to develop asthma.

• 40 percent are more likely to report an experience of congestive heart failure.

The urgency in senior nutrition increases as the percentage of older Minnesotans rises. Hunger Solutions Minnesota analyzed data from the state’s Department of Human Services that pointed to a 23.7 percent increase in food shelf visits by seniors between 2011 and 2015. Seniors are the fastest growing group of food shelf users.

Minnesota mirrors national trends in food insecurity. In that same Spotlight on Senior Health report, Feeding America and the National Foundation to End Senior Hunger concluded:

The Minnesota Department of Heath (MDH) estimates that more than 48,000 Minnesotans age 65 and older who are eligible for Supplemental Nutrition Assistance Program (SNAP) benefits do not take advantage of the program.

Many older adults find it increasingly hard to eat well.

“Between 2001 and 2011, the number of food insecure seniors more than doubled. In 2011, 4.8 million seniors, or 8.4 percent of the senior population, faced food insecurity. This means that nearly 1 in 12 seniors living in the United States had limited or uncertain access to enough food to sustain

The return on investment for older adults and society, when people have access to sufficient and good food, is significant in terms of achievement in safety and in daily living and health risk reductions. Seniors who eat well, get some exercise, and stay social can increase their chances of living well longer and having fewer medical costs.

Around the dinner table The VOA-MN Senior Nutrition program focuses on older adults with low incomes, where a quality diet often takes a back seat to other priorities of life like paying rent, utilities, and other necessities.

Senior nutrition to page 28

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Senior nutrition from page 27

Last year VOA–MN served 323,585 hot lunches for people with low incomes, aged 60 and above, and for many people with disabilities. Ethnic specialty menu options also are available. For example, the regular lunch that Dean enjoys at Charles Horn Terrace is followed twice each week by a catered Somali lunch. Chicken, spiced rice, and root vegetables were on one menu recently, and specialty lunches, catered by small local restaurants, include meals for the Latino, Hmong, and Laotian cultures at some locations. Many of the dining centers also offer special diets: gluten free, vegetarian, soft, and renal (for those with kidney problems).

To further promote independent living, VOA-MN’s Highrise Social Service staff help MPHA residents in 40 apartment buildings navigate the complexities of being poor and often isolated. Those needs span a wide spectrum: economic assistance eligibility—including Medical Assistance, SNAP, and cash assistance—physical and mental health; financial concerns; housing needs; and personal crises. The program coordinates with Hennepin County and other community social service agencies to identify services that will help residents to continue to live independently.

Seniors are the fastest growing group of food shelf users.

This variety exposes older adults to new foods, and the congregate settings provide a social opportunity that many residents would not otherwise have.

While some homebound participants may qualify for delivered meals, most participants gather around the table at common dining centers. Diners are asked to donate what they can, but no one is ever denied a meal because of an inability to pay. The Senior Nutrition program also serves some low-income recipients who live in their own homes but are eligible to visit a dining location to have lunch.

The Senior Nutrition service is funded through a contract with the Metropolitan Area Agency on Aging, Inc. (MAAA), as part of the Older Americans Act, and through participant donations.

MAAA has funded the service for 35 years, helping older adults to thrive at home and maintain their health and independence.

Nancy Christianson is director of senior nutrition for Volunteers of America–Minnesota.

What caregivers should know Visit www.voamnwi.org/senior-nutrition for general information about the VOA–MN Senior Nutrition program, including dining locations. Scroll to the bottom of the page for email and telephone information.

For more information on the Nutrition Assistance Program for Seniors (NAPS), visit the Minnesota Department of Health’s page at http://bit.ly/1WIJsbc.

For more information on Minnesota Hunger Solutions, go to www.hungersolutions.org.

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MINNESOTA HEALTH CARE NEWS APRIL 2016

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Hypertension from page 25

inhibitors (angiotensin-converting enzyme) or ARB’s (angiotensin II receptor blockers), which relax the blood vessels to keep them open and improve blood flow to the heart; 2) calcium channel blockers, which also relax blood vessels; 3) beta blockers, which decrease the force of heart rate contraction and relax the vessels; and 4) diuretics, which decrease the volume of water in the blood and reduce pressure.

If you have a prescription, it’s important to take it as prescribed and report any concerning side effects to your health care provider. Usually a doctor will ask you to check your blood pressure at home and keep a record to review at the next office visit. If a medication does not work for you, there are many more options that might be a better fit. Once diagnosed with hypertension, it’s usually a lifelong commitment to taking blood pressure medications (and in many cases more than one). However, the benefits of decreasing your risks of cardiovascular disease and other health complications are well worth it. Everyone’s treatment plan is different, so talk with your health care provider to develop a plan for you.

Living with hypertension Research on high blood pressure is ongoing, and it’s important to discuss your particular situation with your doctor. In the meantime, follow these steps to manage your blood pressure: • M easure your blood pressure at least annually, more frequently if you have been diagnosed with hypertension.

• E at plenty of fruits and vegetables, working towards a minimum of five servings per day.

• R ead food labels to determine sodium levels, and select lower-sodium options whenever possible.

• T ry to get 40 minutes of physical activity 3–4 times each week, with minimum sessions of at least 10 minutes. For best results, exercise should be moderate, making you slightly breathless. Try using an app or fitness tracker to increase awareness and monitor your activity.

Lifestyle can play a major role in preventing high blood pressure.

• Maintain a healthy body weight. If you’re overweight, even small amounts of weight loss (around 5 percent of body weight) can have significant health benefits.

Thomas Knickelbine, MD, FACC, is director of preventive cardiology at the Minneapolis Heart Institute. Gretchen Benson, RDN, CDE, is healthcare project manager at the Minneapolis Heart Institute Foundation.

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APRIL 2016 MINNESOTA HEALTH CARE NEWS

29

WOMEN’S HEALTH

Abnormal bleeding Evaluation and treatment

By Matthew Palmer, DO

M

enstrual bleeding that comes and goes each month is an expected and normal part of life for most women up until they reach menopause. But what happens if this bleeding pattern becomes disordered? More importantly, what should women who think their bleeding is abnormal do about it?

This article will describe what’s “abnormal” and how gynecologists usually evaluate and treat this problem.

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Normal periods versus abnormal Normal menstrual bleeding is defined as regular bleeding that occurs every 21 to 35 days and lasts no more than seven days at a time.

For most women, this begins around age 9 to 16 and finishes around age 50. Under normal circumstances, a woman’s uterus sheds a limited amount of blood during each menstrual period, usually less than five tablespoons or 80 milliliters.

Abnormal bleeding, more often called abnormal uterine bleeding, is a common problem that affects 5 to 10 percent of women aged 18 to 50 every year in the U.S. About 20 percent of patients coming into a gynecology office are there with concerns about abnormal bleeding.

So what’s abnormal? Bleeding more than five tablespoons during a monthly period isn’t normal. Other criteria for abnormal uterine bleeding include: bleeding that occurs between periods; bleeding after sex; spotting that occurs anytime in the menstrual cycle; bleeding that is heavier or for more days than normal; and bleeding after menopause. The absence of bleeding or having a period for 3 to 6 months, called amenorrhea, is also abnormal. In all of these instances, evaluation by a health care provider is important.

Causes of abnormal bleeding Abnormal uterine bleeding can occur at any age and can have many causes, which makes the case for a thorough evaluation. Causes can include (see following sections for descriptions of some of these conditions): • Pregnancy

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• Miscarriage • Ectopic pregnancy (tubal or other abnormal pregnancy implantation site) • Endometriosis or adenomyosis (endometrial tissue growth outside of the uterine lining) • Some birth control methods, such as an intrauterine device (IUD) or birth control pills • Infection of the uterus or cervix

30

MINNESOTA HEALTH CARE NEWS APRIL 2016

• Fibroids or polyps (benign tissue growths in the uterus or cervix)

medications are often used to treat abnormal bleeding. Birth control pills can make bleeding more regular.

• A blood clotting disorder

Certain types of IUDs can be used for both contraception and control of dysfunctional bleeding. The IUD allows for a slow release of progesterone hormone that thins the uterine lining and may control heavy and dysfunctional bleeding patterns.

• Endometrial hyperplasia (thickening of the cells lining the uterus) • Cancer of the uterus, cervix, or vagina • Polycystic ovarian syndrome (an endocrine system disorder) Special consideration for abnormal bleeding should be given to women who are, or may be, pregnant. In some cases, bleeding during pregnancy can be a normal occurrence or a non-significant finding, depending on the situation and the gestational age of the pregnancy. However, abnormal bleeding may represent an early miscarriage or an ectopic pregnancy, in which a pregnancy implants and grows in an area outside the uterus, most often in the fallopian tube. An ectopic pregnancy can be very dangerous and can lead to a life-threatening problem if not identified early and treated appropriately. A health care provider will help make this determination with an appropriate exam and other diagnostic testing.

Other medications may include non-steroidal anti-inflammatory agents (NSAIDs), such as ibuprofen, antibiotics, or tranexamic acid. Each of these can reduce very heavy menstrual bleeding without the use of hormones.

Surgical treatment options Endometrial ablation. When surgery is indicated for abnormal bleeding, it is most often done in a minimally invasive manner. Many procedures, such as hysteroscopy or endometrial ablation, can be performed in the office setting with little to no downtime. Endometrial ablation is a procedure in which the lining of the endometrium is permanently destroyed by heat or electrical energy so that it cannot re-grow and cause heavy bleeding. An endometrial biopsy is required before this procedure can be performed.

Abnormal uterine bleeding can occur at any age.

Seeking help and evaluation If you think you may be experiencing abnormal uterine bleeding, make an appointment to see your health care provider and get your questions answered. Your personal and family health history are important factors when considering the cause of abnormal uterine bleeding. Tracking your menstrual cycle on a calendar can also be helpful to your provider.

Abnormal bleeding to page 32

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At your appointment, you can expect your provider to perform a physical exam and take a detailed personal and family history.

Blood tests as well as other diagnostic tests may also be performed in the office or surgical center.

Some of these diagnostic tests include: • Sonohysterography. Fluid is placed in the uterus while ultrasound pictures are made of the uterine lining.

• Ultrasound. Sound waves are used to make pictures of the pelvic organs.

• Magnetic resonance imaging (MRI). More detailed pictures are made of the internal organ using powerful magnets.

• Hysteroscopy. A thin camera is inserted through the vagina and cervix to allow the physician to view the inside of the uterus.

• Endometrial biopsy. A thin, plastic tube is used to take a sampling of the endometrial lining that is then evaluated under the microscope.

Nonsurgical treatment options The good news is that most women who experience abnormal uterine bleeding can be treated with a non-surgical approach. Hormonal

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Abnormal bleeding from page 31

The procedure often leaves women unable to conceive, but this is not always the case.

Minimally Invasive Surgery. Other more significant concerns, such as uterine fibroids or adenomyosis, may require surgery. Uterine fibroids, or benign muscular growths of the uterus, are often a cause of abnormal uterine bleeding. Fibroids can also be a cause of infertility and recurrent miscarriage.

For women who still want to have children, a myomectomy, in which the fibroids are removed and the uterine tissue is left intact, may be a minimally invasive option. This procedure can usually be performed laparoscopically or vaginally, in a hospital or surgery center. Laparoscopic procedures, which allow for minimally invasive surgery with or without robotics, are performed using a small camera and small instruments that are introduced into the abdomen area via tiny incisions. Uterine fibroids or polyps may also be removed via a vaginal approach, depending on the size and location of the abnormal tissue.

involves removing the uterus and sometimes the cervix. It can usually be done laparoscopically or vaginally to achieve a minimally invasive outcome. However, it’s important to realize that hysterectomy is major surgery. Afterward, a woman no longer has periods, nor can she get pregnant.

Don’t let abnormal bleeding affect your quality of life.

Hysterectomy. Hysterectomy may be done when other forms of treatment have failed or they are not an option. This procedure

Conclusion Abnormal uterine bleeding is a problem that many women will experience at some point in their lives.

These problems can have a significant impact on a woman’s quality of life. Most problems related to abnormal uterine bleeding are easily treated with little to no time off of work or normal daily schedule. Your health care provider will help determine what type of work-up and what type of treatment is appropriate for your specific condition. Don’t let abnormal bleeding affect your quality of life. Discuss your concerns with your health care provider and find out which treatment options are best for you.

Matthew Palmer, DO, an obstetrics and gynecology physician, sees women at Oakdale ObGyn in Maple Grove. Fellowship-trained in GYN minimally invasive surgical techniques, his special interests include abnormal bleeding, endometriosis, and bladder health.

March 2016 Survey

M I N N E S OTA H E A LT H C A R E

CO N S U M E R A S S O C I AT I O N

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited.

1. I understand what Chronic Traumatic Encephalopathy (CTE) is and how it is contracted.

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2. I believe there should be more medical oversight around head injuries in organized childhood, high school, and college athletics.

3. I believe the rules for organized sports for children should be restructured to limit the potential for head injuries.

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4. I believe there should be higher standards for protective gear designed to limit head injuries in organized childhood athletics.

Strongly agree

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5. I believe parents of children participating in organized athletics with a high potential for head injuries should be given more information about CTE.

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MINNESOTA HEALTH CARE NEWS APRIL 2016

Strongly agree

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Strongly disagree

00

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No opinion

For more information, please visit www.mnhcca.org.

We are pleased to present results of the most recent survey.

Disagree

Strongly disagree

JOIN US.

Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community.

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.

www.mnhcca.org APRIL 2016 MINNESOTA HEALTH CARE NEWS

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Positive psychiatry from page 13

symptoms. The Mediterranean diet is associated with decreased risk of heart disease and cognitive dysfunction.

Sleep is also important to overall health and quality of life. To improve quality of sleep, decrease alcohol, nicotine, and caffeine intake; increase physical activity; and keep the bedroom dark and free of distractions, including electronic devices.

In children, exercise has a positive impact on Attention Deficit Hyperactivity Disorder (ADHD) and depression, and positive parenting techniques can reduce oppositional or defiant behavior. An example of a positive psychiatry model of care in pediatrics is the Vermont Family-Based Approach, which strives to expand the focus of care from illness to wellness and from the individual child to the entire family environment.

While aging of body tissues is inevitable, aging of the mind is not. A positive attitude, a rational mix of optimism and realism, resilience, engagement in stimulating physical and cognitive activities, and having a good time with friends and family—that is the prescription for successful aging.

Positive psychiatry promotes positive mental health.

Behavioral interventions can increase a person’s resilience, change attitudes toward aging or illnesses, reduce levels of perceived stress, lower negative emotions such as anger and anxiety, and increase positive emotions such as enjoyment and empathy, resulting in overall health benefits.

Summary Positive psychiatry promotes positive mental health outcomes such as well-being; psychosocial characteristics such as resilience, optimism, social engagement, spirituality, wisdom, and overall health; and positive changes in behaviors and attitudes. Positive psychiatry has the potential to improve health outcomes and reduce morbidity as well as mortality. More work is needed to make positive psychiatry a norm in practice, but it is time to start that process.

Dilip V. Jeste, MD, is the senior associate dean for Healthy Aging and Senior Care, the Estelle and Edgar Levi Chair in Aging, the Distinguished Professor of Psychiatry and Neurosciences, and director of the Sam and Rose Stein Institute for Research on Aging at the University of California, San Diego. He is board-certified in general psychiatry and geriatric psychiatry. He is a past president of the American Psychiatric Association, and is a member of the Institute of Medicine.

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34

MINNESOTA HEALTH CARE NEWS APRIL 2016

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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1

for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials.

Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%).

Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.

In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator.

After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown.

Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death.

OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

More detailed information is available upon request.

For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending.

Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied.

CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease.

All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin.

Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established.

Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.

Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8

mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%).

Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients.

Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested

®

Victoza —a force for change in type 2 diabetes.

A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks.

Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a

b

A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.

The change begins at VictozaPro.com.

Indications and Usage

Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise.

Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Victoza® has not been studied in combination with prandial insulin. ®

Important Safety Information

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.

Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly.

There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation.

Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.

There is limited data in patients with renal or hepatic impairment.

In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%).

Please see brief summary of Prescribing Information on adjacent page.

1013-00018617-1

December 2013