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June 2016 • Volume 14 Number 6

Bicycle safety By Thomas E. Kottke, MD, MSPH, and Jo Olson

Mosquito-borne illnesses By Franny Dorr, MPH

Health literacy By Alisha Ellwood Odhiambo, MA, LMFT


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CONTENTS

4 7 8

JUNE 2016 • VOLUME 14

NUMBER 6

MINNESOTA HEALTH CARE ROUNDTABLE

16

NEWS

INFECTIOUS DISEASES

Travel-associated mosquito-borne risks What you need to know

PEOPLE

PERSPECTIVE

Individualized medicine  Health care at the genetic level Keith Stewart, MD

FORTY-SIXTH SESSION

Value - Based  Purchasing:  

By Franny Dorr, MPH

18 20

CALENDAR

A new way to pay for health care BEHAVIORAL HEALTH

Early intervention in psychosis A new era of hope

Mayo Clinic Center for  By Michael O’Sullivan, MD Individualized Medicine

10 12

10 QUESTIONS

Ensuring your wishes Health care economics A look at documents Stefan Gildemeister and procedures State Health  By Robert McLeod, JD Economist and Director of the MDH Health PRIMARY CARE Economics Preventive health Program

PUBLIC HEALTH

Bicycle safety Common sense for riders and motorists

By Thomas E. Kottke, MD, MSPH, and Jo Olson

14

22

M EDICINE AND THE LAW

TAKE CARE

Health literacy Better information, better outcomes

26

exams Improving your quality of life  By Dania Kamp, MD, FAAFP

28

PHYSICAL FITNESS

Understanding body mass index One gauge of healthy weight  By Susan Masemer, MS

By Alisha Ellwood Odhiambo, MA, LMFT

Thursday, November 3, 2016 • 1:00-4:00 PM

The Towers The Gallery Gallery (lobby level), Downtown Minneapolis Hilton and Towers

Background Background and Focus: As initiatives driven by federal health care care reform move forward, the term “Value-Based Purchasing” (VBP) does (VBP) is being applied to a wide spectrum of issues. But what does this this mean? CMS is developing measurements, well over 150 to date, date, to define what “value” means in health care. It is proposed that that these metrics will be used to create incentives that pay more for Hospitals, for better care in every element of health care delivery. Hospitals, physician physician practices, home care, and long-term care will all be reimbursed reimbursed by an emerging new math. Objectives: Objectives: We will explore the motivations behind this changing approach approach to purchasing health care. We will examine what is being the being measured and what value really means. We will discuss the arguments that claim VBP is a bad idea and those that believe it is is arguments the best solution. We will discuss how a collaborative, transparent the system, system, that integrates care teams, health information technology, and increased and improved reimbursement methods will help achieve increased access access to high-quality, cost-effective care for patients. Panelists Panelists include: • Curtis Hanson, MD, Chief Medical Officer, Mayo Mayo Medical Laboratories Sponsors Laboratories Sponsors include: • Athena Health • Mayo Medical Laboratories Please tickets at $95.00 per ticket. Tickets may be ordered ordered by by Please send me phone (mppub. phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), Publishing. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail note: Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets tickets are non-refundable.

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JUNE 2016 MINNESOTA HEALTH CARE NEWS

3


NEWS

One in Three Antibiotic Prescriptions Unnecessary Between 2010 and 2011, an estimated 30 percent of outpatient antibiotic prescriptions in the U.S. were unnecessary, according to a new study. Eva Enns, PhD, an assistant professor at the University of Minnesota School of Public Health’s division of health policy and management, worked with researchers at the Centers for Disease Control and Prevention (CDC) as well as various U.S. colleges to determine how many outpatient visits had antibiotics inappropriately prescribed. “Antibiotic resistance is increasing—we are seeing the emergence of infections that are resistant to all available treatments,” said Enns. “Luckily these are still rare, but MRSA, one of the most publicized cases of antibiotic resistance, was once a rare condition, too, limited to inpatient settings. But now we’re seeing it more and more, even in community settings.”

The researchers analyzed data from the 2010–2011 National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey, which showed that nearly 262 million total outpatient antibiotic prescriptions were sold throughout the year. That’s an annual antibiotic prescription rate of 506 per 1,000 population. Based on clinical guidelines and geographic variation in prescribing, they estimated the proportion of antibiotic prescriptions that were likely inappropriate, which was 153 of 506, or about 30 percent. “Antibiotic resistance is an inevitable consequence of antibiotic use, both appropriate or inappropriate,” said Enns. “The key is to conserve antibiotics for the cases in which they are truly needed.” Antibiotic resistance causes 23,000 deaths each year, according to the CDC, and the White House has implemented the National Action Plan for Combating Antibiotic-Resistant Bacteria, which has a goal of reducing inappropriate antibiotic use by 50 percent by the year

2020. The results of this study offer a baseline to monitor and compare progress in the future.

Savings Accounts for People With Disabilities Coming this Fall Minnesotans with disabilities and their families will soon have the ability to create tax-free savings accounts that won’t count against eligibility for public programs such as Medical Assistance and Social Security Supplemental Income. Minnesota is one of 40 states that approved the tax-free savings accounts under the federal Achieving a Better Life Experience (ABLE) Act of 2014. Under the ABLE legislation, families of children with disabilities can save up to $14,000 per year and the account could grow to as much as $100,000 before public benefits would be affected. Previously, people with disabilities could only save $2,000 without impacting their public benefits. Families can use the

funds for disability-related expenses including education, health care, dental care, job training, housing, and transportation. Contributions won’t be tax deductible, but interest earned on the savings and withdrawals for qualified expenses will be tax-free. “The ABLE Act allows people with disabilities and their families to save funds for education, assistive technology, housing, transportation, and other goods and services not included in public benefits,” said Emily Johnson Piper, human services commissioner. “Many people living with disabilities want to work and build earnings and families also want to contribute funds that can be used to maintain health, independence, and quality of life.” Minnesota and eight other states have formed a consortium to research implementation of the program. The states are working together to offer investment options, but each will operate its own ABLE program. Other states in the consortium include Alaska, Illinois, Iowa, Kansas, Missouri, Nevada, Pennsylvania, and Rhode Island.

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The ABLE accounts are expected to be available in Minnesota this fall. A person must have a significant disability with an onset before age 26 to qualify. Steve Larson, policy director of The Arc Minnesota, estimated that 100,000 or more Minnesotans would be eligible for ABLE accounts when the legislation passed in 2015.

Drug Overdose Deaths Continue to Rise Deaths due to drug overdoses in Minnesota increased 11 percent from 2014 to 2015, according to new data from the Minnesota Department of Health (MDH), continuing a trend of rising deaths due to drug overdoses in the state. There were 516 drug overdose deaths in 2014 and 572 in 2015— a large increase from 129 in the year 2000. In 2015, more than half of the deaths due to drug overdoses were related to prescription medications. The most common ones cited were opioid pain relievers (216), heroin (114), stimulants such as methamphetamines (78), benzodiazepines (71), and cocaine (38). Death rates related to all these drugs have increased since 2011, with the exception of cocaine—deaths due to cocaine overdoses have stayed relatively steady at around 30 to 40 deaths per year since 2011. “The increase of deaths due to prescription and heroin opiate abuse is a tragedy for many Minnesota families and communities. We have all been affected,” said Emily Johnson Piper, Minnesota human services commissioner. “We are working on many fronts including moving upstream to decrease excessive prescribing, getting medications into our communities to treat overdosing, and improving access for those who have become addicted. We are moving with purpose to address this growing crisis.” The seven-county metro area saw an increase in the rate and number of drug-related deaths from 2014 to 2015; Greater Minnesota’s numbers remained about the same. In 2015, the metro area had a rate of 11.6 deaths per 100,000 residents and Greater Minnesota had a slightly lower rate of 9.3 per 100,000. Both areas had rates less than 3.0 per 100,000 in the year 2000.

The majority of Minnesota’s drug-related deaths were unintentional drug overdoses, which continue to rise. Suicide deaths involving drugs also increased, from 36 in 2000 to 100 in 2015. And according to MDH, unintentional overdoses that result in death are only a small percentage of all drug overdoses in the state. An analysis of 2014 hospital admissions shows that for every death related to unintentional overdoses, there were more than six hospital admissions for drug overdoses. Most of the hospitalizations were related to antidepressants, barbiturates, and other sedatives and psychotropic drugs.

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Fetal Alcohol Syndrome Training Required for Foster Parents Gov. Mark Dayton has signed into law a new bill that will require foster care providers to complete specialized training on fetal alcohol spectrum disorder (FASD). The bill was passed unanimously by the Senate and the House of Representatives. FASD is 10 times more common in the foster care system than in the general population and 7,000 babies are born with prenatal alcohol exposure each year in Minnesota, according to the Minnesota Organization on Fetal Alcohol Syndrome (MOFAS). Foster care providers must complete one hour of training on FASD and on how to parent a child that is affected by the disorder within the first 12 months of receiving their foster care license. Providers can count the hour training toward their annual requirement of 12 hours of in-service training. “Children with FASD may present as typical at first glance, but living with and parenting them can be incredibly challenging, frustrating, and, occasionally, unsafe,” said Sara Messelt, executive director of MOFAS. “This training not only will help foster parents understand how to parent a child with FASD, but also how to access services and support for their child and for themselves.” News to page 6

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News from page 5

Allina to Combine Mercy and Unity Hospitals Allina Health System has announced that its Unity Hospital in Fridley and Mercy Hospital in Coon Rapids will operate as one hospital starting Jan. 1, 2017. The two will share the name Mercy Hospital and Unity Hospital will be known as Mercy Hospital–Unity Campus. The goal is to strengthen specialty services and reduce unnecessary duplication at the hospitals. Allina Health is calling the plan “One Hospital, Two Campuses.” The next step in the plan is to consolidate inpatient mental health and addiction medicine services, which are currently located at both campuses, to the Unity campus in Fridley. A nursing unit at Unity will be renovated to support the adult inpatient mental health services that are currently located at Mercy Hospital. According to Allina Health, more than 60 percent of the

hospitals’ mental health patients also struggle with addiction issues. The move, meant to help improve access to care for these patients, will take place in early 2017.

consulting company specializing in health care facilities, owns the building and is funding the construction project. Work could begin as early as August, pending approval from the Maplewood City Council.

HealthEast Planning Multispecialty Center New Law Provides Better Training for in Maplewood Caregivers HealthEast has announced that it will be the lead tenant in a three-story, 80,000-square-foot multispecialty center in Maplewood, near St. John’s Hospital. The health care system is still finalizing plans for the space, but says it will support its vision for primary care and ambulatory surgery. “Our vision is to reimagine the outpatient experience and establish an exceptional destination that will optimize care coordination and patient flow,” said Eric Nelson, vice president of operations for ambulatory care and medical services at HealthEast. The Davis Group, a Minneapolis-based real estate brokerage and

Gov. Mark Dayton has signed the CARE (Caregiver Advise, Record, Enable) Act into law, which will require hospitals to provide patients the opportunity to designate a caregiver and provide that caregiver with a discharge plan and aftercare instructions. The caregiver must be kept informed about the patient’s status and provided with an explanation and demonstration of the medical tasks they will need to perform at home after leaving the hospital. “Caregivers are performing more and more complex medical tasks that used to be provided by an at-home nurse,” said Seth Boffeli, communications director of AARP

Minnesota. “If we’re going to ask them to do more, we need to better prepare them.” The bill passed the Senate last year and passed the House in early May this year with a unanimous vote. It will go into effect in 2017 and affect more than 670,000 unpaid family caregivers, according to AARP. More than 20 other states have passed similar legislation. The Minnesota Hospital Association worked with the bill’s authors—Sen. Kent Eken (D-Twin Valley) and Rep. Nick Zerwas (R-Elk River)—to add verbiage to the bill that protects hospitals from litigation for care provided by a designated caregiver and an ability for hospitals to deny the caregiver designation if it is determined that they are unable to perform the duties called for in the discharge plan. It also omitted the requirement of procuring a second written consent for sharing the individual’s health record information with the designated caregiver.

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MINNESOTA HEALTH CARE NEWS JUNE 2016


PEOPLE Deb Krause has been appointed to the position of vice president of the Minnesota Health Action Group. As part of her new role, Krause leads program development, management, and administration of Minnesota Bridges to Excellence, a program that recognizes clinics across the state for delivering optimal care. Previously, Krause served as a princiDeb Krause pal at Mercer, a global consulting company, and as director of social responsibility at UnitedHealth Group. She has been active in volunteer leadership for nonprofit health and community organizations for more than 25 years and currently serves as the chair of the American Cancer Society’s Minnesota State Leadership Board.

Love

Scott Jensen, MD, president of Catalyst Medical Clinic, PA, in Watertown, has been named the 2016 Family Physician of the Year by the Minnesota Academy of Family Physicians. Jensen has been a practicing family physician for more than 32 years and opened Catalyst Medical Clinic in 2001. He also teaches one day a month as a clinical associate Scott Jensen, MD professor at the University of Minnesota Family Medicine Residency program in St. Louis Park and serves as medical director of Pro Rehab, Inc., in Watertown. Jensen earned his medical degree at the University of Minnesota Medical School. He completed both his residency and internship at Bethesda Hospital. Jensen has served as president of local Lions and Rotary clubs and multiple chambers of commerce and was elected to the District 110 school board where he served for 10 years, including three years as chairperson. He is now running for a state Senate position in Minnesota District 47. Stephanie Hemmer, DO, has joined Entira Family Clinics’ Woodbury Clinic as a family medicine provider. Hemmer has been a physician for four years and has a special interest in pediatrics and women’s health, including prenatal care but excluding delivery. She is teaming up with two physicians from the West St. Paul Clinic to deliver her prenatal Stephanie patients. Hemmer earned her doctor of osteopathy Hemmer, DO degree from Kirksville College of Osteopathic Medicine in Missouri and completed a residency through the University of Minnesota/St. Cloud Family Medicine Residency Program. Sarah Magnuson, DDS, owner of Lake Sarah Dental, PPLC, in Greenfield, has received the 2016 New Dentist Leadership Award from the Minnesota Dental Association for her commitment to organized dentistry and for demonstrating generosity and leadership. Prior to opening her clinic in 2014, Magnuson practiced at Children’s Dental Services Sarah Magnuson, and at NorthPoint Health and Wellness Center in DDS Minneapolis where she specialized in children and adolescent patients, particularly those who faced barriers to accessing dental care. She has worked with mobile and school-based clinics and serves as the lead for organizing and managing supplies for the Minnesota Mission of Mercy mobile dental events. Magnuson has also participated for several years in Give Kids a Smile, TeamSmile, Donated Dental Services, and Feed My Starving Children, and is a volunteer dentist each month at the Sharing & Caring Hands dental clinic. She also initiated an internship program with the local high school to mentor future dental professionals. Magnuson earned her degree from the University of Minnesota School of Dentistry.

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JUNE 2016 MINNESOTA HEALTH CARE NEWS

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PERSPECTIVE

Individualized medicine Health care at the genetic level

I

Keith Stewart, MD Mayo Clinic Center for Individualized Medicine

Dr. Stewart is the Carlson and Nelson Endowed Director at the Mayo Clinic Center for Individualized Medicine, which is dedicated to discovering new ways to prevent, predict, diagnose, and treat disease.

ndividualized or precision medicine will continue to accelerate and revolutionize how we manage health and disease, specifically in the area of genomic data. We now have the capability to sequence a patient’s entire genome—the complete set of DNA contained in each cell nucleus—to better quantify risk, diagnose disease more accurately, and provide safer treatments specifically tailored to the individual patient. As director of the Mayo Clinic Center for Individualized Medicine, my goal is for every patient to benefit from the promise of precision medicine. Indeed, within the next 10–15 years, we predict it will be possible for every human born in the U.S. to have their genome sequenced as a routine test. We are already reaping the benefits of this new technology. Specific examples include employing genomic sequencing to reach the correct diagnosis faster, provide safer drug prescribing, and identify novel treatments for cancer.

Targeting advanced cancer

I was trained as a hematologist, a specialist who studies the blood. Early in my career, I became interested in the treatment of hematologic malignancies such as leukemia and multiple myeloma, a cancer formed by malignant plasma cells. It became clear to me that since these diseases were caused by genetic defects, understanding the defect and looking for solutions was going to be a part of my future. For the past 20 years I have investigated human genomics and molecular biology to understand and better apply treatments to blood cancers.

Drugs act differently in different people.

Some patients seek answers for years, searching with their physicians for the correct diagnosis. We call this a Diagnostic Odyssey and offer genomic sequencing to try and solve these difficult cases. Of the patients who enter the Mayo Clinic Individualized Medicine Diagnostic Odyssey Clinic with an undiagnosed, likely genetic disorder, approximately 30 percent receive a diagnosis to help inform future treatment plans.

At Mayo Clinic we often see patients whose cancers have exhausted all of the treatment options that have proven survival benefits. Those people then receive advanced genome analysis of their normal DNA and tumor DNA to identify genetic mutations that may be causing or advancing the cancer. This information is used to find any available treatments that can target those specific mutations. For half of the patients who enter the Individualized Medicine Clinic, researchers discover a sequencing-based druggable target that provides a new treatment option.

Matching medicine to patient

Meeting unmet needs

Reaching the correct diagnosis

Drugs act differently in different people. Because of genetic differences, some patients may be allergic or hypersensitive to certain medications that are tolerated quite well by others. The study of how these genetic variations influence response to drug therapy is called pharmacogenomics, a field pioneered by Mayo Clinic researchers nearly a generation ago that benefits from advancements in human genomics. Mayo Clinic continues to play a leading role in pharmacogenomics, tailoring medication to meet the needs of the individual. To date, we have implemented 20 decision support rules in

8

our medical record to help avoid serious drug reactions and to prevent prescribing a drug that we can know in advance will not work for the individual patient. These alerts have been triggered thousands of times, helping to ensure that patients receive the right drug at the right time.

MINNESOTA HEALTH CARE NEWS JUNE 2016

Whether we’re gathering data to find the right answers or identifying the right treatments, Mayo Clinic’s goal is to meet the unmet medical needs of all patients. When the Precision Medicine Initiative was launched in 2015 by President Obama, this bold project aimed to revolutionize how we improve and treat disease. With new technologies, federal funding, nationwide participation, and health care organizations such as Mayo Clinic Center for Individualized Medicine, I believe the treatments and diagnostics of today will be rapidly modernized, and the concept of individualized treatment will quickly be a reality.


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

JUNE 2016 MINNESOTA HEALTH CARE NEWS

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10 QUESTIONS

Health care economics Stefan Gildemeister Mr. Gildemeister is the state health economist and director of the Health Economics Program at the Minnesota Department of Health. What does the state health economist do? I lead the Health Economics Program, which monitors trends in the Minnesota health care market with a focus on access, costs, health care use, and provider quality. Our team analyzes health care data from a range of sources to provide policymakers and the administration with objective information on a broad set of policy issues. In other words, we monitor state and national trends, collect and analyze data, and synthesize our research findings for a diverse set of audiences. What can you tell us about the Minnesota All Payer Claims Database (MN APCD)? Minnesota invested early on in the development of a dataset that integrates data on administrative health care transactions from public and private payers. Because of the richness of diagnostic and treatment information, as well as data on payments for health care services, it can serve to inform several important system-level policy decisions. MDH’s current authority permits us to do this system-level work through June 2016 unless the Legislature acts to extend that authority. What kind of questions do you help answer? The topics we get to work on can be very broad, ranging from big picture questions to highly technical dives into specific aspects of health care. For example, we study how many people in Minnesota are uninsured and we estimate the state’s health care spending. But we also study questions such as whether the current capacity of radiation therapy facilities in Minnesota is sufficient to meet future needs or the extent to which patients overuse emergency rooms or experience potentially avoidable hospital readmissions. What are some of the projects that you are currently working on? We released two reports in which we identify the burden of chronic disease in Minnesota and provide an accounting of trends in how much we spend on health care. Some of this research benefited from the availability of the MN APCD, a rich data source we’re just beginning to use more effectively. Other high-​ priority studies include: 1) Collaborating with the University of Minnesota to understand changes in

10

MINNESOTA HEALTH CARE NEWS JUNE 2016

insurance coverage and access in Minnesota to produce new rates of uninsurance. 2) Studying opportunities available to state policymakers to create a balanced playing field among health insurance providers in the individual and small group market in Minnesota. 3) Reporting, for the first time, on health care use and quality of care for children in Minnesota. 4) Describing how quality measurement can be affected by patient demographic characteristics. 5) Studying new information on drug spending to help assess the sustainability of prescription drug spending. How do you know that the work you are doing is successful? There are different ways to know whether our work has made a difference. Most important is how useful the analysis is for policymakers and their deliberations, and we get a sense for this based on legislative requests for testimony or reports. We also consider general media coverage an indication of relevance, or whether the community uses our analysis and research findings. Some of our most rewarding work involves providing evidence that fills knowledge gaps and promotes change on the ground. What are some areas where you see room for cost savings in health care delivery? Reducing health care spending is complex, as the last 20 years of rising costs have shown. Minnesota and the U.S. are testing some promising models that could slow the rate of spending growth—I’m less optimistic that we can actually reduce levels of spending. Many of these efforts focus on the idea of delivering the right care at the right place at the right time, particularly for complex patients. The majority of health care spending is concentrated among patients with chronic conditions and other complex health needs, so there is an opportunity for bending the cost curve by improving the coordination of their care or delaying the onset of disease. Since prices, including for prescription drugs, are important drivers of spending growth, we need to look for payment models that support effective health care use and constrain irrational price inflation. What’s an issue that you think is going to have a greater and greater impact on the cost of health care in Minnesota, which isn’t yet getting a lot of attention? Largely in response to the rising cost of health care services, we spend a lot of time discussing insurance product design for the entire population, generally looking for ways to constrain premium growth through cost sharing mechanisms. A promising alternative area of focus are people with the highest health care needs and spending. If 10 percent of the population is responsible for about 67 percent of costs, why do we spend so much time


on the 90 percent who account for a small share of total spending? By managing care for the most complex patients better, we might not only be able to produce better experiences for these patients, we might also be able to reduce average per-person spending so successfully that actual premiums could stay flat instead of rising. It sounds like the MN APCD can help us understand more about the cost of care. How does this benefit the consumer? Patients didn’t used to spend much time wondering about the cost of care. As patients, we now ask whether tests were repeated, whether information is available among providers who take care of us, or whether a brand-name drug is necessary in place of an equivalent generic product. As patients have become responsible for a greater share of health care spending, including through higher deductible plans, understanding the cost of care is a pocketbook issue.

full effect of the ACA. We do know insured rates have risen, bringing coverage and peace of mind to many, all apparently without a decline in the role that employers play offering coverage. We’ve also seen that hospital-based uncompensated care has declined as coverage rates increased. Again, this is a trend that was driven by ACA implementation. We expect that our work over the next few months will contribute to our understanding of how access to care has changed, in part because of the ACA. We are also working on documenting trends in the non-group insurance market, where we expected the most change because of the ACA through regulatory change, some standardization in benefit design, and availability of financial subsidies to purchasing coverage.

Patients didn’t used to spend much time wondering about the cost of care.

In a more global sense, it is important for everyone to understand the vast resources that are being dedicated to health care, because it affects what as a society we can spend on other policy priorities. Though these costs are often masked because insurers, the government, and employers foot parts of the bill, they are real and they affect everyone because costs are spread across an insurance pool and we support payments for people on public health insurance, like Medicare for the elderly, through tax payments. How has the ACA affected Minnesota’s health care market? I think we still have an incomplete understanding of the

What information would you like from patients to help you use the data you collect in the most efficient way? Because our analysis is generally at the health system level, we don’t generally collect information from patients directly. Still, as patients increasingly play a greater role in managing their health care, it would be helpful to know what information is of value to them. For instance, we collect data from provider clinics on the share of their patients that receive optimal diabetes care. We also ask about their patients’ experience with health care delivery. What would be good for us to understand is whether this kind of information is actually meaningful to people who seek diabetes care or if other data would be of greater use.

JUNE 2016 MINNESOTA HEALTH CARE NEWS

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PUBLIC HEALTH

Bicycle safety Common sense for riders and motorists By Thomas E. Kottke, MD, MSPH, and Jo Olson

M

innesota is the land of 10,000 lakes and more than 4,000 miles of paved state, regional, and municipal bicycle trails. Whether you’re bicycling on a county road near Center City, riding in a bike lane in Frazee, or zipping down the Midtown Greenway in Minneapolis, you’re likely to see people pedaling all types of bicycles, from tandems to recumbents, from speedy road bikes to trusty commuters. Our state has a lot to boast about when it comes to bicycling participation and bicycling infrastructure. In fact, the League of American Bicyclists ranks Minnesota as the second most bicycle-​ friendly state in the U.S. The health benefits are numerous, but cyclists of all ages should observe common-sense safety tips when­ ever they hit the trails.

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Exercise with a touch of transportation People seeking low-impact and accessible modes of exercise often turn to bicycling, which also provides recreation, transportation, and cardiovascular conditioning. Research shows that short bursts of exercise, such as bicycling to the post office or grocery store on a regular basis, can contribute to heart health. In addition to the obvious physical benefits, cycling can also be a mood-booster; several trials demonstrate that, for people suffering from depression, physical activity can be more effective than medications. Studies also show that children who ride bikes or walk to school are more physically active, less likely to be obese, and more likely to meet physical activity guidelines than those who are driven or bused to school. There’s also strong evidence to connect physical activity, such as bicycling, to improvements in attendance rates and student academic performance, including grades and standardized test scores.

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MINNESOTA HEALTH CARE NEWS JUNE 2016

Stay in your lane When everyone—both motorists and bicyclists—follows the “rules of the road” and respects each other, we’re all much safer. Bicycles are legally considered to be vehicles on the road and have almost all the rights that motorists do. If the lane is too narrow to share sideby-side with a motor vehicle, bicyclists are within their legal rights to “take the lane” to discourage illegal, unsafe passing. Additionally, motorists who pass bicyclists are legally required to maintain three feet of space from the side of their vehicle. (For more information about bike laws and safety, see Minnesota Statute 169.222.) Safety first Some Minnesotans may be wary of getting on their bicycle, especially if they’ve had a long break from riding. Here are some basic safety


precautions that all bicyclists should follow, no matter their age or bicycling experience. Dress for the occasion. You can ride in everyday clothes, but if you’re going for a longer ride, a ride at night, or a ride in inclement weather, you may want to wear something special. If it looks like precipitation, bring a rain jacket to save yourself from tire splatter. If you’re going to be out past dark, wear bright or reflective clothing. Be seen at night. Always use a white headlight and a red rear light. These, along with bright clothes and reflectors, will help make you more visible in low light or at night. In Minnesota, a white headlight visible from a distance of at least 500 feet is required on the front of the bike, as is a red reflector or red taillight that is visible from 600 feet to the rear. Adding more than one light or reflector is legal and can increase safety.

is running smoothly. Do this by spinning a pedal backward a few times. Your chain should be lubricated with bicycle lube and not be dry or rusty. If your bike has Quick releases on wheels, check to make sure that they aren’t open. Finally, Check your bike for anything that seems wrong: listen carefully as you begin to ride for any rubbing, grinding, or clicking that might indicate something isn’t working correctly.

Never ride while distracted… talking on the phone, texting, or intoxicated.

Do the “ABC Quick Check.” Make sure your bike is in safe working order before hopping on. Check the tires to ensure they have enough Air. Use the pressure recommended on the sidewall of the tire; if you don’t have a gauge, squeeze to make sure they are as hard as a basketball. Squeeze the Brakes to make sure you can fit your thumb between the brake lever and the handlebar. If you can’t, it’s time for an adjustment. Also, lean down and check your brake pads along the wheel to make sure they aren’t worn down. Next, check your Chain, Crank and Cassette to make sure your chain

Doing the ABC Quick Check can find problems before they affect your safety or cost you more money to repair.

Wear a helmet that fits properly and has been treated gently. When you shake your head from side to side, a correctly fitted helmet will always stay in place. If a helmet is dropped frequently or has been in a prior accident, it may have structural damage and should be discarded and replaced.

Even the safest bicyclist can crash or experience an injury from bicycling. If a bike isn’t fitted properly, you can injure your muscles or joints. If you’re unsure of what size bike you need, visit a local bike shop where professionals can give expert advice and let you test ride different bicycles. Bike fit is very personal. There is no one-sizefits-all solution, so take your time when choosing the right bike. Hazards ahead All bicyclists should be aware of and on the lookout for hazards on the roads and trails. Never ride while distracted (talking on the phone, Bicycle safety to page 34

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TAKE CARE

Better information, better outcomes By Alisha Ellwood Odhiambo, MA, LMFT

“T

ry both Aleve 2pills bid with flexeril at hs.” “You have a 20 percent coinsurance and a $500 deductible.”

“Everyone should get preventive screenings and vaccinations at the recommended timeframes.” If you don’t understand these, you’re not alone. According to the U.S. Department of Education, nearly nine out of 10 Americans have some level of difficulty understanding and using the everyday health information that is routinely available to them—a skillset defined as “health literacy”—and only 12 percent of English-speaking adults have proficient health literacy skills.

Minnesota Optometric Association

Doctors on the frontline of eye and vision care Did you know?

• Diabetic retinopathy can be controlled and diabetic patients need regular eye exams to maintain vision and good eye health. • Diabetes Type ll can also cause vision changes. • Glaucoma must be diagnosed in early stages in order to prevent vision loss. • All children entering school need a comprehensive eye exam, because vision screenings do not detect a number of eye disorders. • To maintain eye health, everybody from babies to boomers to older adults needs a regular eye exam by a family eye doctor. To locate an optometrist near you and find comprehensive information about eye health visit http://Minnesota.aoa.org

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MINNESOTA HEALTH CARE NEWS JUNE 2016

In its simplest terms, health literacy refers to an individual’s capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. However, the implications go far beyond being a smart consumer or following medical instructions. For some, low health literacy can lead to poor decisions or unintentional errors, causing long-term and perhaps even irreversible health consequences. A new set of recommendations developed by a broad-based Minnesota coalition attempts to reduce those risks. (See sidebar for tips on how you can increase your own level of health literacy.) A team effort The Minnesota Health Literacy Partnership (MHLP), a collaboration of Minnesota health care consumers, health care organizations, and literacy groups, works to educate health care providers about the importance of clear health communication, empower consumers to ask for clear health communication, and share health literacy resources. The MHLP believes that: • Low health literacy affects everyone. • Patients should be empowered to ask questions of health care professionals and systems so they can make informed choices. • Educational strategies and techniques increase clear communication with patients. • Clear communication increases patient safety. • Health literacy is one of the strongest predictors of health status. • Health literacy principles and programs can have greater impact when tailored to the needs of specific communities. Low health literacy impacts a person’s health more than any other factor, including education, income, employment, or race, according to the American Medical Association’s “Health Literacy and Patient Safety: Help Patients Understand” report. People with low health literacy may fail to seek preventive care, are less likely to follow prescribed treatments, stay in the hospital longer, and feel ashamed to ask for help making health care decisions. They may also be unable to speak up about their care, advocate for themselves, or make informed choices about their lifestyles and health practices. Those with low health literacy represent all segments of society, including many who are highly educated. Lawyers, for example, may have trouble figuring out medication schedules while on a business


trip. Computer programmers may wonder if they can drink coffee before a lab test that requires fasting. Busy parents may spend time searching the local drug store for the right medicine to reduce a 5-year-old’s fever. Research shows that all patients, not just those with limited health literacy skills, prefer easy-to-understand health information. While low health literacy can affect any patient, those most at risk are older adults, people with limited education, members of ethnic minorities, and recent immigrants to the United States. For Minnesotans to adopt healthy behaviors and make responsible, well-informed health decisions, they must have access to clear, understandable information. There are several reasons why this is hard to achieve:

1. Adopt and use health literacy best practices across all verbal,

written, and visual communication. To make it easier for consumers to access and understand health information, the health care community should develop and implement best practices for providing written, verbal, and visual health information in jargon-free, understandable language. 2. Make information about health relevant

and accessible. Patients and their caregivers should have easy access to usable information presented in a variety of mediums so they can understand diagnoses, make treatment and prevention decisions, and evaluate health risks.

Only 12 percent of Englishspeaking adults have proficient health literacy skills.

The health care system is fragmented and complex. In recent years the health care system has grown increasingly complex and people oftentimes do not understand how or where to seek help. The burden of navigating health and health care is placed on the consumer. The responsibility often falls on patients and their caregivers to find information and connect and coordinate the health care organizations involved in their care. There is a lack of understandable and usable information available to consumers. While many organizations offer tools and resources for understanding health and the health care system, there is often a lack of awareness among the general public and many health professionals that these tools and resources exist. Additionally, existing resources are frequently written or communicated at a level that is beyond the skills of the average consumer due to the use of complicated medical terminology and insurance jargon.

3. Increase and improve patient-​

centered resources. Health care professionals should provide patients with the necessary resources to understand the health care system and receive the most appropriate care. Whether individual assistance is provided in-person, by phone, or online, health care professionals should help patients coordinate and navigate health care.

4. I mplement and enhance education opportunities at all levels.

Health literacy concepts should be integrated into primary, secondary, and professional education. Health literacy to page 32

Sociodemographic differences affect how people understand health information. Language, income, education, culture, insurance status, age, disability, race, and geography all play a role in how people understand and interact with health care. Responding to the problem Recognizing these facts, 43 Minnesota health organizations, including insurers, providers, patient advocacy groups, and other health organizations, joined forces to develop the Minnesota Action Plan to Improve Health Literacy. The plan, released in March, is the result of a six-month process to engage dozens of stakeholders statewide in conversations about barriers to health literacy and possible solutions. The engagement process was led by a steering committee with representatives from the American Cancer Society Cancer Action Network, the American Heart Association, Blue Cross and Blue Shield of Minnesota, the Minnesota Health Literacy Partnership, and Portico Healthnet. Priorities for improving health literacy The Minnesota Action Plan to Improve Health Literacy identifies six priorities with actionable strategies to help improve Minnesotans’ abilities to obtain, understand, and act on health resources: JUNE 2016 MINNESOTA HEALTH CARE NEWS

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INFECTIOUS DISEASES

Travel-associated mosquito-borne risks What you need to know By Franny Dorr, MPH

Aedes aegypti

(yellow fever mosquito)

T

he current Zika disease outbreak affecting many Latin American and Caribbean countries provides a timely opportunity to highlight mosquito-borne diseases that travelers might encounter. Mosquito-borne disease risks can vary considerably depending on geographic location, local mosquito ecology, time of year, and the traveler’s length of stay and previous exposure to mosquito-borne viruses. Growth in international travel and commerce introduced two new viruses—chikungunya in 2013 and Zika in 2015—to Latin American and Caribbean islands, two areas previously free of local transmission.

In the next issue... Your Guide to Consumer Information

• Domestic violence • Food-borne illness • Heart valve replacement 16

MINNESOTA HEALTH CARE NEWS JUNE 2016

This article highlights mosquito-borne diseases in traveling residents most commonly reported to the Minnesota Department of Health (MDH). Although there are many mosquito-borne diseases worldwide, some travel-associated diseases are reported to MDH more often than others, including malaria, emerging viral diseases such as chikungunya and Zika, and re-emerging diseases such as dengue. Malaria Malaria is the most commonly reported travel-associated mosquito-​ borne disease in Minnesota, with an average of 54 cases annually from 2010–2014. The vast majority of these cases occurred in foreign-born residents returning to their country of origin, with most reported cases involving Liberia and Nigeria. Notably, Minnesota has the largest Liberian population in the world outside of the country itself. Malaria is a global problem, with an estimated 198 million clinical cases and 500,000 deaths in 2013 alone. Caused by several protozoan species, malaria is endemic in many tropical and subtropical regions of the world, most notably throughout much of Africa, India, parts of Southeast Asia, and much of northern South America. Malaria is transmitted to humans through bites by one genus of infected mosquitoes, with most people developing symptoms within one month. Malaria is a serious febrile illness (one including or caused by fever), with many nonspecific symptoms that may become severe, resulting in organ failure and cerebral malaria. Prophylactic (preventive) measures to limit your risk and post-infection treatment vary depending on location of travel and the species of mosquito circulating in the area. Malaria diagnosis is confirmed by blood tests or PCR testing involving the patient’s DNA. Chikungunya Prior to 2013, chikungunya virus transmission was not recognized in the Western Hemisphere, but it has recently emerged as a commonly reported disease in Minnesota travelers. Following a rapid spread in the Caribbean islands and Latin America, the virus was reported in 2014 in Florida, which saw 12 locally acquired cases of infection with the virus. After that small outbreak, there has been no further local transmission reported in the United States. In 2014, there were 28 cases of travel-associated chikungunya


disease reported to MDH, most of them following trips to the Caribbean islands. Chikungunya virus is transmitted to humans through the bites of two species of infected mosquitoes, commonly referred to as the yellow fever and Asian tiger mosquitoes. Most people who are infected with chikungunya virus will develop symptoms, usually within three to seven days of infection. The most common symptoms include fever and joint pain (arthralgia), but may also include headache, joint swelling, rash, and muscle pain (myalgia). Severe illness and death are rare, but symptoms of arthralgia may persist for several months following infection. Treatment for chikungunya disease is limited to supportive care. Chikungunya can be diagnosed using serology or PCR testing.

days of infection and may be mild, including fever (which typically lasts two to seven days), headache, arthralgia, and myalgia. Occasionally, symptoms rapidly progress to a more severe disease, characterized by hemorrhage or shock. Risk for severe dengue is greatest during the post-febrile period of the illness. There is no specific treatment for dengue disease, only supportive care to manage symptoms. Until dengue can be ruled out, use of NSAIDs is not recommended due to increased risk of hemorrhage. Dengue infections can be diagnosed using serology or PCR testing. Other emerging diseases of interest The MDH also monitors several other mosquito-borne diseases that are not commonly seen in U.S. travelers, including Rift Valley Fever virus, Murray Valley encephalitis virus, yellow fever, and Japanese encephalitis. For more information, visit the department’s mosquito-transmitted diseases website at www.health.state.mn.us/divs/idepc/dtopics/ mosquitoborne/.

Local transmission of [Zika] is not expected to occur in Minnesota.

Zika Most recently, Zika virus has made its way into much of Latin America and the Caribbean following its introduction to the region in the spring of 2015. Zika virus is transmitted primarily by the yellow fever species and possibly the Asian tiger species of mosquito. Like chikungunya before it, the rapid spread of the virus is primarily due to infected individuals traveling to areas with competent mosquito vectors (mosquitoes that survive the Zika virus and can transmit it by bite) and previously unexposed populations. Local transmission of the virus is not expected to occur in Minnesota due to the lack of appropriate vector populations—in other words, the mosquitoes that transmit most cases of Zika virus do not live here.

The Centers for Disease Control and Prevention (CDC) also provides information and assessment of mosquito-borne disease risk for travelers, as well as a “Yellow Book” with health information for international travel. Search the CDC site at www.cdc.gov. Travel-associated mosquito-borne risks to page 19

Nearly 80 percent of Zika infections produce no symptoms. When symptoms do develop, they are usually mild, including fever, arthralgia, rash, and conjunctivitis. These symptoms typically develop within three to 14 days following infection, and may last up to a week. There is growing evidence that Zika infection in pregnant women may be linked to birth defects such as microcephaly or spontaneous abortion. There is also a possible link between Zika disease and Guillain-Barré syndrome. These reported links are still under investigation. Zika is treated with supportive care to manage symptoms. The CDC recommends that pregnant women should not travel to countries and territories with active Zika virus transmission. Dengue Dengue is one of the most frequently occurring mosquito-borne diseases worldwide. MDH has received an average of 11 case reports annually from 2010–2014, most of which were acquired in Latin America. Dengue is not considered endemic in the United States; however, outbreaks have occurred in warmer states, such as Texas and Hawaii, where appropriate mosquito vectors are found. Regions of the world with endemic dengue include Africa, India and Southeast Asia, Latin America, and the Caribbean. Dengue virus is transmitted to humans through the bite of infected yellow fever or Asian tiger mosquitoes. There are four distinct serotypes of dengue virus, and subsequent infections with different serotypes are possible. Symptoms usually occur within four to seven

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Calendar June-July 2016 June 16

Advance Care Planning HealthPartners offers this free class on advance care planning specifically for Minnesota residents. Come get the tools you need to assess your goals, values, and beliefs about end-of-life care; get tips on how to initiate a conversation with loved ones; and how to choose a surrogate decision-maker. Call (800) 429-0383 to register. Thursday, June 16, 6   –   7 p. m., Lakeview Hospital, 927 Churchill St. W., Stillwater

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Hope for Recovery NAMI Minnesota hosts this free information session offering practical strategies for dealing with the complexities of mental illness. Come learn about treatments, coping strategies, the mental health system, and local resources. Please bring your own lunch. Call (651) 645-2948 to register.

Saturday, June 18, 9 a. m. – 3 p. m., Anoka – ​Metro Regional Treatment Center, 3301 7th Ave., Anoka

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Doula Information Night Amma Parenting Center doulas lead this free workshop for expecting parents who are interested in learning more about doula services. Come learn the role of a doula, how families can incorporate a doula into their care team, and the benefits of having a doula at your birth. Call (952) 926-2229 to sign up. Tuesday, June 21, 6:30 – 7:30 p. m., Amma Parenting Center, 3511 Hazelton Rd., Edina

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Dementia Caregiver Support HealthEast hosts this twice-monthly support group for family and friends of a person with frontotemporal dementia to connect, ask questions, share concerns, and learn strategies for coping and caregiving. There is no cost and no registration is necessary. For more information, call Lynn at (651) 232-2202. Monday, June 27, 6 – 8 p. m., Bethesda Hospital, 559 N. Capitol Blvd., St. Paul

National Cancer Survivors Day As advances are made in prevention, detection, treatment, and follow-up care, more people than ever are surviving after being diagnosed with cancer. There are more than 14.5 million people living with a history of cancer in the U.S. alone. Life after a cancer diagnosis can be long and rewarding. However, survivors often continue to face hardships years after diagnosis and treatment, including physical, emotional, and financial hardships. They are at a greater risk for developing second cancers and other health conditions, and may face challenges such as limited access to health care specialists and new treatments, difficulty finding jobs, and economic burdens due to medical expenses, lost wages, and reduced productivity. National Cancer Survivors Day is an annual celebration of life for those living with a history of cancer, as well as a day to draw attention to the ongoing challenges of cancer survivorship and promote more resources, research, and survivor-friendly legislation to improve cancer survivors’ quality of life.

June 14

After Cancer Treatment

Park Nicollet hosts this free information session for patients who are nearing the end of, or have already finished, cancer treatment. Come discuss the common emotional ups and downs many experience at this stage as well as strategies to anticipate and manage these feelings. Significant others, family members, and caregivers welcome. Preregistration required. Call (952) 993-5700. Tuesday, June 14, 9 –10 a. m., Park Nicollet Frauenshuh Cancer Center – Curtis and Arlene Carlson Family Community Room, 3931 Louisiana Ave. S., St. Louis Park

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.

July 2

Grandparents of Kids with FASD The Minnesota Organization on Fetal Alcohol Syndrome offers this monthly support group for grandparents, foster parents, and other relative caregivers of children affected by Fetal Alcohol Spectrum Disorders (FASD). Gather with other caregivers to informally share resources, insights, and support. For more details, call Amy at (651) 917-2370. Saturday, July 2, 10 – 11:30 a. m., Brookdale Library – Creekside Room, 6125 Shingle Creek Pkwy., Brooklyn Center

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Health Insurance Counseling for Seniors The Metropolitan Area Agency on Aging and Hennepin County Library host free sessions for seniors with a certified state health insurance counselor to assist with enrollment steps, plan choices, and determining low-income subsidies. Sessions are private and are limited to one individual or couple per session. Other dates, times, and locations available. For more information or to sign up, call (612) 543-5669. Thursday, July 7, 9–10 a.m., Southdale Library, 7001 York Ave. S., Edina

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Scleroderma Support Group The Scleroderma Foundation –  ​Minnesota Chapter hosts this monthly support group for anyone affected by scleroderma. Come share your feelings and concerns and gain information and peer support. Before attending a meeting for the first time, please call Nancy at (763) 424-1155. Wednesday, July 13, 6 – 8 p. m., Unity Hospital – Classroom C, 550 Osborne Rd. NE, Fridley

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Anxiety Workshop Thrive Therapy offers this free workshop for anyone who struggles with the symptoms of anxiety. A licensed professional clinical counselor will teach techniques to alleviate worry and fear, discover peace of mind, and improve your self-esteem, health, and relationships. For more information or to RSVP, call (612) 568-6050.

Saturday, July 30, 11 a. m. – 12:30 p. m., Thrive Therapy, 190 River Ridge Cir. S., Burnsville

America’s leading source of health information online 18

MINNESOTA HEALTH CARE NEWS JUNE 2016


Travel-associated mosquito-borne risks from page 17

Local mosquito-borne disease risk Minnesota has several endemic mosquito-​borne diseases. West Nile virus is endemic throughout Minnesota and the U.S., and is the most frequently reported mosquito-borne disease in the state, with an average of 36 cases annually from 2010–2014. Other endemic mosquito-borne viruses in Minnesota include La Crosse encephalitis virus, which can cause neuroinvasive illness in children, and Jamestown Canyon virus. Less common mosquito-borne diseases in Minnesota include Western equine encephalitis and Eastern equine encephalitis. The risk for acquiring mosquito-borne diseases in Minnesota is highest during the months of July through September.

subtropical countries, including screened-in windows or air conditioning that limit exposure to mosquitoes. Widespread access to the Internet, television, video games, etc., keeps many of us indoors. Wetland drainage and agricultural land use greatly diminish the breeding habitat for many mosquitoes. In much of the country, cold winters greatly reduce mosquito activity and subsequent virus amplification and transmission for the majority of the year. Finally, there are hundreds of local mosquito control agencies throughout the country that play a large role in reducing mosquito-borne disease risk. Locally, Minnesota has the Metropolitan Mosquito Control District (MMCD), which operates within the seven-county metropolitan area. MMCD maintains extensive surveillance and control of exotic mosquito introductions, including the detection and elimination of seasonal introductions of Asian tiger mosquitoes.

Malaria is the most commonly reported travelassociated mosquito-borne disease in Minnesota.

The global perspective In general, mosquito-borne disease risk is much lower in the United States compared to abroad. This is true even in the southern states that have established mosquito vector populations for many of the diseases discussed in this article. Among the reasons: U.S. buildings have much better structural integrity than those in most tropical and

Don’t Suffer Alone

Franny Dorr, MPH, is an epidemiologist in the Vectorborne Diseases Unit at the Minnesota Department of Health.

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19


BEHAVIOR AL HEALTH

Early intervention in psychosis A new era of hope By Michael O’Sullivan, MD

P

sychosis is a serious mental disorder impairing brain development and function, leading to hallucinations, delusions, and cognitive impairment. It affects up to 3 to 6 percent of the population, with approximately 600 new cases each year in Minnesota. Developing in late adolescence and early adulthood, it is associated with increased suicide risk, poor quality of life for individuals and their families, and considerable cost. Psychosis can have multiple causes, including substance abuse or withdrawal, exposure to severe stress, medical conditions or diseases, and mood disorders.

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MINNESOTA HEALTH CARE NEWS JUNE 2016

However, more often than not, it signals the onset of schizophrenia or bipolar disorder. Most often detected at ages 14–30, it can severely disrupt the social, academic, and vocational development of young adults, only 25 percent of whom experience just one episode and completely recover. Those suffering from schizophrenia—the most common psychotic illness, and the most serious form of mental illness—may achieve symptomatic remission, but few recover completely, and most are left with secondary disabilities such as functional impairment, social exclusion, unemployment, and poverty. Early intervention is key Psychosis often goes untreated for one to two years, at which point interventions may achieve only modest benefits, and often at high cost. First Episode Psychosis Programs or Early Intervention Programs strive to reach patients earlier, targeting those experiencing their first episode of psychosis. “Early” is as early as possible following the onset of psychotic symptoms; “intervention” is comprehensive, intensive, phase-specific, and individualized. The first such program was piloted in 1992 in Melbourne, Australia; since that time, programs in multiple nations have demonstrated that early intervention services are no more expensive than traditional services and in fact may be more cost effective. Here at home, the University of Minnesota’s First Episode Psychosis Program worked to define a methodology for how these programs can be shaped for those in need. The Youth Psychiatry and Early Intervention in Psychosis program at Abbott Northwestern Hospital continues this approach, and the Legislature approved funding last year for programs serving areas hit hardest by homelessness, suicide, and poverty. Duration of untreated psychosis Longer duration of untreated psychosis (DUP) has been associated with increased suicide risk and poorer outcomes at six months, four years, and 15 years. Prolonged DUP can mean loss of functioning, increased likelihood of hospitalization, higher dosages of medication, treatment-resistant symptoms, unemployment, incomplete recovery, and escalating treatment costs.


In Norway, researchers studied DUP within an intervention area where an education campaign was carried out and a control area where no intervention was delivered. The activities (radio, newspaper, bus shelter ads, and more) were typical of a health marketing campaign. The results were striking: the DUP in the education area dropped from 118 weeks to 26, while no significant change occurred in the control area. Patients accessing services with the shorter DUP were less unwell and functioned better than those with the longer DUP and those in the control area. Patients with the shorter DUP were less likely to be admitted to the hospital.

Who benefits from treatment? First Episode Psychosis Programs provide mental health services targeting 14- to 29-year-olds and integrate child, adolescent, and adult mental health services. These programs work in partnership with primary care, education, social services, youth, and other relevant services, reaching out to patients who have not had treatment or just recently initiated treatment and providing a comprehensive assessment performed by a specialized professional or community physician. Treatment emphasizes managing symptoms and role fulfillment rather than diagnosis. The focus is on the individual and his or her family. Part of the “state of mind” is providing services that are youth-friendly and flexible.

Continuity of care is essential in preventing psychotic relapse.

First episode psychosis programs in Minnesota A virtually identical (culturally adapted) program was proposed in Minnesota to reduce the duration of untreated psychosis. The first of its type in the Upper Midwest, it strived to provide an evidence-based template for mental health systems across Minnesota to reduce unnecessary delays in accessing care and to improve outcomes for people with psychosis.

Many people have asked where this First Episode Program is located. I usually borrow my answer from a colleague at the Columbia University First Episode Clinic: “It’s a state of mind, not a location.” The program is actually a network of social workers, family members, psychologists, psychiatrists, psychiatric nurses, and community organizations that work with young people with psychosis. Many patients are seen for medication management by community psychiatrists and attend various group therapies at the M Health Hospital. Beginning last year, I have applied the lessons of the University of Minnesota’s First Episode Psychosis Program at Abbott Northwestern Hospital’s First Episode Psychosis Clinic. Treatment Optimal care at first episode psychosis clinics consists of comprehensive, integrated biopsychosocial approaches (i.e., medication, psychosocial interventions, and patient and family education) tailored to the unique characteristics of each individual and the phases of their illness. Treatment is age appropriate and provided in a destigmatizing, recovery-focused context. Care is holistic and focused on the “whole person,” including a patient’s ethnic and cultural background, rather than on the signs and symptoms of psychosis. The person and the family are engaged as active collaborators in care from the start. Community-based supports are essential to treatment. Services and supports need to be comprehensive and involve multiple sectors (e.g., vocational, economic, physical health, educational, and recreational). These programs utilize broad community-based services to assist patients and their families in recovery, including peer support, family support networks, and other appropriate community-based resources.

Ideally, assessments take place in the most comfortable environment possible (e.g., home visits or community outreach). Continuity of care is essential in preventing psychotic relapse. After five years in these programs, many patients then transition to a more general psychosis program. Early intervention in psychosis to page 25

The Best Choice for Women’s Health Care V Low- and high-risk obstetrics, including older moms-to-be.

V Menopause Clinic, including management of peri-menopause.

V Certified nurse midwifery.

V Center for Urinary and Pelvic Health, including urodynamics (urinary leaking evaluation).

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

V Nutrition and wellness consultations.

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21


MEDICINE AND THE L AW

E nsu r i ng you r w ish es A look at documents and procedures By Robert McLeod, JD

I

t’s a situation that many of us have encountered, or perhaps even feared: A medical decision must be made on behalf of a family member, but no one is quite sure who has the legal authority to make the decision—or how to make the decision. It could be a minor child whose parents are unavailable, a competent adult rendered unconscious or in a coma, or a person lacking decision-making abilities due to dementia or other forms of incapacity. When these situations arise, medical professionals and the people who want to help, usually family, require guidance to assess what type of health care the person actually wants and the legal authority

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Health Care Directive Every adult Minnesotan should have a written Health Care Directive. There is no specific form for a Health Care Directive (although there are formal signing requirements), and documents may vary widely from individual to individual. These variations allow the document to be flexible and to accommodate all of your wishes and intentions. Most people appoint an agent, a trusted family member or acquaintance who will speak on your behalf if you do not have the ability to communicate your health care decisions. You may grant this agent power to make decisions for you, but most people prefer to include instructions to the agent to carry out their intentions. The instructions themselves can vary: some Health Care Directives are very specific in the decisions they want their agent to make, while others provide very general instructions to ensure that agents carry out their general health care intentions. In some cases, people do not even appoint an agent and just create a Health Care Directive that provides instructions to medical professionals regarding their preferences for medical care. Many people have heard horror stories about medical decisions that had to be made for someone who was unconscious or incompetent. In almost every case, these involved a patient who did not have a Health Care Directive. By creating a Health Care Directive you reduce the risk of becoming one of those nightmare cases.

Medical re

Jeffrey Mil ler, MD, and Timothy Schacker, MD

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to ensure that health care decisions are made consistent with that person’s intentions. There are several different legal procedures and documents addressing such health care decisions. Some of them involve advance planning covering multiple situations, while other situations may require very specific and peculiar legal action, including, in extreme circumstances, a court-ordered custodian or guardian.

You will also lift the burden of making medical decisions from your loved ones. Without a Health Care Directive, your loved ones may be left with guilt and doubt in trying to decide what is best for you or what you really wanted done. Your Health Care Directive communicates your intentions, making it easier for your loved ones and medical professionals to accomplish your intentions when you are not able to speak for yourself. The most unfortunate situation is when medical decisions have to be made and neither the medical professionals nor your loved ones have any realistic idea of what your intentions would have been.


The most useful Health Care Directive will provide a general road map to carry out your intentions. It will include the appointment of at least one agent and perhaps an alternate agent to make decisions for you. A Health Care Directive will usually provide instructions to your agent that, at the very least, convey your general ideas for your health care (particularly when end-of-life decisions must be made). The Health Care Directive should also include such important things as whether you want to be an organ donor or how you would like your remains handled after your death such as cremation or burial. Remember that the Health Care Directive, in general, will only apply when you are not able to speak for yourself.

POLST forms are frequently deemed by medical professionals to have more power than your Health Care Directive. Because the medical orders contained in a POLST are considered to supersede or take control over a Health Care Directive, you should exercise the same care and thought that went into your Health Care Directive before you ever sign a POLST. The POLST is not as flexible as a Health Care Directive and has only a few options related to emergency medical decisions, so before you sign a POLST, be sure that your intentions are stated consistently with your Health Care Directive. Power of attorney If you have a minor child, your life circumstances may change, making you unavailable for a period of time to provide care or to make decisions affecting your child. In these circumstances, Minnesota law allows you to create a temporary power of attorney to give someone else the authority to make decisions, including medical decisions, for your minor child. This type of document should be drawn up with the help of a competent attorney. The document delegates your power as a parent of the child and gives the power to another person of your choosing to make decisions for your child. This document does not last longer than one year.

Consult with a competent attorney to discuss these alternatives.

POLST Another tool employed to ensure medical intentions is the POLST form (Provider Order for Life-Sustaining Treatment). These short documents, often prepared at a hospital or care facility, specify the patient’s wishes for emergency interventions in the event of a medical crisis or during follow-up inpatient care. Emergency responders are required to follow POLST orders; without a POLST form, they would be required to provide every possible medical treatment to sustain life.

Ensuring your wishes to page 24

JUNE 2016 MINNESOTA HEALTH CARE NEWS

23


Ensuring your wishes from page 23

Standby Custodian If you need to grant someone decision-making power for a minor child and that power must last longer than one year, consider a Temporary or Standby Custodian. This is a legal process where a person is appointed by the court to be custodian of the minor child. Once again, you will need the help of a competent lawyer to get a temporary or standby custodian appointed. Guardianship Finally, in extreme cases in which all other remedies are ineffective, a court-ordered guardian can be appointed for a child or for an adult who has lost the capacity to make sound decisions. In general, guardianship is the last procedure you would want to use, but it sometimes becomes the only available option, since there is no Health Care Directive or any other legal process to make decisions for those who cannot make their own decisions.

then make health care decisions for the person under guardianship. Any time you have to involve the court in these types of personal decisions, it is a very difficult situation for everyone involved.

You will do yourself and your loved ones a great favor by completing a Health Care Directive.

This involves going to court and having a guardian appointed to act on behalf of the minor or incapacitated adult. The guardian can

Conclusion Considering all of the variables and, in particular, the relative low cost of creating a Health Care Directive, you will do yourself and your loved ones a great favor by completing a Health Care Directive. If an unfortunate situation does arise, your loved ones and medical providers can then provide for your care in a very efficient and useful manner. If you want decisions made for your children, a temporary power of attorney or standby custodial arrangement may be a good option. You may want to consult with a competent attorney to discuss these alternatives for your health care.

Robert McLeod, JD, is a shareholder with the law firm of Briggs and Morgan. A member of the firm’s Trusts and Estates section, he practices primarily in the areas of estate planning, taxation, probate, trusts, and guardianships and conservatorships.

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24

MINNESOTA HEALTH CARE NEWS JUNE 2016


The future As these services expand to other health systems, Minnesota will keep pace with worldwide trends in modern service delivery for those with psychosis. The next stage will be a multidisciplinary team of trainers for mental health service providers developing early intervention in their health system/community. Minnesota was fortunate to have been a site for the research-based RAISE program (Recovery After an Initial Schizophrenia Episode) and many of the service providers and trainers continue to work in Minnesota.

Early intervention in psychosis from page 21

Program components The M Health First Episode Psychosis Program may serve as a model for similar programs in Minnesota and elsewhere. Key components include an eight-week family education and support group, followed by caregiver support groups; young adult cognitive behavioral therapy/resiliency training groups; cognitive remediation utilizing computer programs to enhance cognition; emergency room access for those needing immediate psychiatric attention for medication management, acute exacerbation of symptoms, and suicidal or homicidal thoughts or actions; an inpatient psychosis unit for patients who are a danger to themselves or others; and specialized/individualized medication management.

International efforts to intervene early in the course of psychotic disorders suggest that radically improved outcomes may be possible for young people experiencing psychosis. Early psychosis intervention represents a new era of hope for those facing the challenges of serious mental illness. Spurred on by this hope, momentum is building across Minnesota to provide early intervention services.

Ideally, assessments take place in the most comfortable environment possible.

These modules, however, are not sufficient to fully address the needs of a person recovering from a psychotic episode, possibly with a lifelong diagnosis of schizophrenia or bipolar affective disorder. Ongoing individualized psychological, family, and psychosocial interventions are required to help the person manage their illness effectively, return to work or school, and live independently.

Michael O’Sullivan, MD, is board-certified in psychiatry and integrative and holistic medicine. Formerly the medical director of the First Episode Psychosis Program at the University of Minnesota, he is currently a staff psychiatrist at Abbott Northwestern Hospital, where he is building an integrative and holistic first episode psychosis program.

RemaRkable caRe when it counts we realize that any surgery is a major event in your life. that’s why we make every effort to make you feel at ease. when you visit specialists in General surgery, you’ll receive care that is tailored to you as an individual. From discussing the details of your surgery in familiar terms to helping answer any questions, our coordinated team of surgeons and staff will be with you every step of the way. at specialists in General surgery, you can count on us to provide you the surgical expertise you need and the remarkable care you deserve.

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PRIMARY CARE

Preventive health exams Improving your quality of life By Dania Kamp, MD, FAAFP

W

hile preventive care exams have always been a fundamental component of primary care physicians’ practices, increased coverage for these exams under the Affordable Care Act (ACA) has led to a renewed emphasis. Preventive care focuses on prevention and/or early detection of health risks. With early intervention, we can decrease the impact of these health conditions and disease burdens, improving both quality of life and overall survival.

Telephone Equipment Distribution (TED) Program

Ounces (and pounds) of prevention But what topics might be covered in a preventive health exam visit? Of course, these will vary for each individual and should be customized for your specific health needs based on age, sex, genetic factors, and lifestyle habits. You and your physician should work

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

26

MINNESOTA HEALTH CARE NEWS JUNE 2016

together to best assess your personal risk factors and develop a plan for improving your overall health. Recognize that the most important ways to minimize your risks will require not just testing or lab work, but changing your behavior or modifying your lifestyle. An annual preventive visit and exam will provide a framework on which you and your provider can build a plan for your overall health. That framework could include: Immunizations. One of the simplest health maintenance pieces is making sure your immunizations are up to date. In children, there are many immunizations that can prevent communicable diseases for a lifetime. Adolescents should receive boosters of some childhood shots, along with specific age-appropriate vaccines (such as vaccines for HPV or meningitis), especially before entering college or playing sports. For adults, immunization status will depend on other health conditions (such as lung disease or diabetes) and on age, and may include vaccines for tetanus, pneumonia, shingles, whooping cough, and some forms of hepatitis. Certain people in high-risk occupations or those with upcoming travel plans should ask their doctor if other vaccines are recommended for them. Home safety. This applies to patients of all ages, from early “childproofing” to decreasing fall risks for elderly patients. Your provider likely will discuss safety issues related to the home, including drowning risks, gun safety, risks for lead exposure, fall risks, and driving safety. Your provider may ask for family input into these, especially if you are older or live alone. Eyes, teeth, ears. Your physician might also ask about other health care done outside of the clinic setting. Have you seen the eye


doctor in the past year for a vision assessment or to be screened for conditions such as cataracts or glaucoma? Are you visiting the dentist regularly for dental examinations and cleanings, as well as taking care of your teeth at home with brushing and flossing? Are you getting adequate sources of fluoride to help prevent dental health problems in the future, especially important for kids while they are building their teeth for their whole life? In addition to the above, more offices are providing a hearing assessment at the time of preventive visits.

• Tobacco use and cessation • Alcohol intake • Drug use (current, and/or history of) • Caffeine intake • Sexual activity, and risk for sexually transmitted infections and pregnancy • S unscreen use/sun prevention

Many of the risks to your health are from modifiable factors.

Screenings. Many screening interventions are focused on detecting diseases at an earlier state to decrease costs and disease burden, and to improve survivability and quality of life. Cancer screenings are classic examples of disease detection. Pap smears for cervical cancer screening are likely the first cancer screening for most women, beginning at age 21. Other cancer screenings may include breast, colon, and prostate cancer, depending on age, sex, or family history of these diseases. There may be recommendations for genetic testing based on family history of certain cancers. Screening recommendations may change frequently as new medical information is available, so talking with your doctor about your individual risks and recommendations is important and should be addressed annually. Other medical conditions. In addition to cancers, other medical conditions that often are screened for include depression, diabetes, obesity, vascular disease, osteoporosis, and dementia. While these are all important, the prevalence of diabetes is increasing worldwide, with 12–14 percent of Americans having the disease, based on 2011–2012 estimates published in a recent JAMA article. There are various ways of screening for diabetes via blood testing of glucose (sugar) levels or hemoglobin A1C levels. In addition to screening for diabetes, your provider will likely talk with you about lifestyle factors that are important for preventing the disease (or if you have already been diagnosed, that are the foundation for managing your diabetes). Obesity is the biggest risk for development of type 2 diabetes. Your Body Mass Index (BMI) will be calculated at your visit, and this should lead into discussion of your general diet and exercise activity. Your BMI and lifestyle also greatly affect your risk for development of vascular diseases, including heart attack and stroke. These risks, combined with family history, smoking status, blood pressure, and cholesterol measurements, can aid you and your doctor in determining your risk for having a heart attack, and whether medications, combined with lifestyle changes, would be beneficial.

• Dietary choices • Seat belt use • S afety/violence in your home and relationships • S tress reduction and self/ spiritual care These factors all play a role in your overall health, and you and your doctor should work together to determine a strategy that is best for you. Your provider may discuss other health resources, such as a dietician or mental health clinician. For example, if you smoke or use tobacco, this likely will be a focus area for your provider to address with you, including behavior changes, medication options, or a possible referral to help you quit smoking. Your visit should focus on an assessment of your willingness to change behaviors, a plan to address these Preventive health exams to page 31

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Read us online Wherever you are!

A healthy lifestyle We’ve already alluded several times to the importance of lifestyle in preventive health. Many of the risks to your health are from modifiable factors, or things that you can control, as opposed to genetics or family history, over which you have no control. A partial list of lifestyle concerns your health team might address includes: JUNE 2016 MINNESOTA HEALTH CARE NEWS

27


PHYSICAL FITNESS

Understanding body mass index One gauge of healthy weight By Susan Masemer, MS

M

any of us step on the scale or watch clothing sizes, but these may not provide the best gauge of our ideal size. In fact, there is no single “right” shape or size. We’re all unique, with different genetic potential and body composition that dictate our basic body type and build. Consider your personal goals as you work towards your own personal right size. Do you wish to enhance your stamina for daily

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tasks, or do you want to more fully enjoy recreational activities? Do you hope to excel in sports, or is it more important to achieve a toned body for aesthetic reasons? Whatever your personal goal, it should include attaining not just your best size, but also your best overall health. Body mass index (BMI) could be one part of your program plan. Assessing your right body size There are a number of measurements that can provide some insight into whether you are the right size. Calculating your BMI is easy and can give you a general sense of how healthy your weight is, especially if you are not physically active. You don’t need to visit your doctor to determine your BMI. To do it yourself: Read a chart. A simple web search will show several charts plotting weight and size, the key determinants in assessing BMI. The chart at http://bit.ly/1Tk1wbw, for example, shows that an individual who is 5 feet 11 inches tall and weighs between 154 and 164 pounds will have a BMI of 22. Calculate online. Along with basic charts, you’ll also find online calculators. Many of these calculate based just on height and weight. Others, such as AllinaHealth’s calculator at http://bit.ly/1TW7Dmj, also ask for the user’s gender and pregnancy status. The Centers for Disease Control and Prevention posts a special calculator for those ages 2 to 19 at http://1.usa.gov/1V6xuuh. Crunch your own numbers. Do the math yourself in three steps:

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What the numbers mean For most (but not all) individuals, the higher the BMI score, the higher the percentage of body fat to muscle. Your BMI provides an initial assessment of healthy weight and health risk factors. There are five categories of BMI scores:

28

MINNESOTA HEALTH CARE NEWS JUNE 2016


BMI Category

Below 18.5

18.5–24

25–29.9 Overweight

30–39.9 Obese

40 or more

Underweight Healthy (normal weight)

Women miss an important opportunity if they don’t add strength training to their exercise routine. Adding muscle provides a more sculpted appearance, and additional muscle burns more calories. The idea that women will get too bulky from strength training is a myth. Don’t take an all-or-nothing approach by binge dieting, cutting out important nutrients, or starving yourself. It’s not healthy or sustainable.

Extreme or High-Risk Obesity

Your total body fat is related to your risk of obesity and your risk of diseases and death related to obesity. These diseases include type 2 diabetes, high blood pressure, heart disease, stroke, arthritis, respiratory disorders, high cholesterol, and certain cancers. If your BMI score indicates you are at risk for such diseases, there are things you can do to reduce your risk and protect your health. Your physician may recommend a diet, lifestyle, and exercise regimen, or may help assess whether you are a candidate for weight-loss surgery.

Teens can be especially confused by the BMI index. BMI is a good tool to use, but it can sometimes be hard to understand. Because of the changes the teen body is going through, body fat can change just as quickly.

You can make lifestyle changes to lower your BMI.

There’s more to it than BMI BMI alone may not be the most accurate measure of a person’s ideal weight. BMI can’t differentiate between lean weight (muscle) and fat. It is biased against a person who might register as overweight according to BMI standards, but is mostly muscle, which weighs more than fat. Michael Jordan, for example, registered a BMI of 27–29. The guidelines differ for the very young and the very old, as well. For those older than 65, a slightly higher BMI of 25–27 may reduce risk of osteoporosis. And parents of very young children should ask their pediatrician about weight concerns rather than relying on standard BMI calculations.

Tips to achieve your right size You can make lifestyle changes to lower your BMI. These include eating a healthful diet and getting regular physical activity.

There are no quick solutions, no magic diets, and nothing to buy to help you lose weight. The only healthful, successful way to lose weight is by making smart food choices and getting regular physical activity. Understanding body mass index to page 30

Have You heard about the BioMat?

So while BMI provides a quick assessment of risk, a more accurate indicator is to measure your percentage of body fat. When it comes to extra body fat, it’s all about location, location, location. Fat located in your abdomen is called visceral fat, or toxic fat. It’s considered dangerous because excess fat stored in the gut cavity can release toxins around your vital organs. People who carry extra weight around their waist rather than their hips are at a higher risk for heart disease and type 2 diabetes. The risk goes up with waist measurements greater than 35 inches for women and greater than 40 inches for men. To measure your waist, put a measuring tape snugly around your waist (where you bend). Breathe out and measure. In addition to the size of your waist, if you have a BMI score in the overweight, obese, or extreme obese range, your health care provider may use other indicators to assess your risk of disease: high blood pressure, high LDL cholesterol (the “bad” cholesterol), low HDL cholesterol (the “good” cholesterol), high triglycerides, high blood glucose (sugar), family history of premature heart disease, physical inactivity, and cigarette smoking. Mistakes to avoid when trying to achieve your right size Avoid comparing your body to someone else’s, especially someone you see in the media. Your body is simply different than theirs, and photos can be airbrushed or otherwise manipulated.

This amazing medical-grade infrared heating mat can change your life for the better. It is used in homes and professional healing practices all over the world. The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic conditions that have not responded well to medication therapy.

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Understanding body mass index from page 29

If you’re struggling, seek expert help. Meet with a registered dietitian or exercise physiologist. A fitness trainer is fine, too, if he or she is highly credentialed. A health and wellness coach can help you put together a realistic strategy.

Small steps If you are at increased risk for obesity-related diseases, talk with your provider. Even a small weight loss (just 10 percent of your current weight) will help you lower your risk of developing diseases associated with obesity. Know that you can make improvements in your body shape by accumulating more physical activity throughout the day. Several small activity sessions can provide significant and pain-free benefits. You don’t need to join an expensive gym, attend grueling training classes, or hire a personal trainer to make great progress. Begin “where you are” and increase your efforts to reach your goals. If you desire an athletic looking body or want to improve athletic performance, know it will take a bigger commitment of time and intensity. Start simple by logging your eating and exercise habits. Keep track on an app, or even on paper. Wearable activity trackers are very popular and help keep you accountable to yourself.

Think long term Don’t let someone else set unrealistic expectations for you. Find real experts to help you determine what body shape will help you meet your needs and goals. It is important to recheck your body composition from time to time, to make sure you are maintaining a healthy balance of muscle and fat.

Avoid comparing your body to someone else’s.

We tend to lose a significant amount of muscle each decade of life—especially if we are not doing strengthening activities. It is important to maintain muscle, which in turn keeps us strong and our metabolism revving for optimal calorie burning and weight maintenance.

Susan Masemer, MS, is an exercise physiologist and manager of LiveWell Fitness Center at the Penny George Institute for Health and Healing, part of Allina Health.

WHO’S A BIGGER BASEBALL FAN, YOU OR ME? You’ll find that people with Down syndrome have a passion for knowledge and learning that can rival anyone you’ve met before. To learn more about the rewards of knowing or raising someone with Down syndrome, contact your local Down syndrome organization. Or visit www.dsamn.org today. It is the mission of the Down Syndrome Association of Minnesota to provide information, resources and support to individuals with Down syndrome, their families and their communities. We offer a wide range of services, programs and materials at no charge. If you are interested in receiving one of our information packets for new or expectant parents, please email Kathleen@dsamn.org or For more information please call:

(651) 603-0720 • (800) 511-3696 30

MINNESOTA HEALTH CARE NEWS JUNE 2016

©2007 National Down Syndrome Congress


Preventive health exams from page 27

concerns, and a way to follow up on your changes. While lifestyle modification is never easy, it may have the most important lasting effects on your body, your relationships, and your health. Finally, an area that is receiving more focus during preventive health visits is advance care planning. This is not just important for geriatric patients or terminally ill patients, but for all of us. You should be having a conversation with your doctor, your family, and loved ones regarding your wishes if you were unable to speak for yourself. This can include appointing a health care power of attorney, discussing your goals and quality of life, and stating your wishes regarding various health interventions. While these conversations are never easy, they are easier to have when you can participate and discuss them in a non-emergent situation. Get started Preventive health is a fundamental component of your health care. The above information provides you with a starting point for a conversation with your physician about your specific health

care needs and goals. Remember that, under the ACA, many preventive care items are now covered under your insurance plan, with no impact on deductibles, copays, or co-insurance. Recognize the importance that your day-to-day activities play in your health, and work to change your lifestyle in positive ways for your overall well-being. Some additional preventive health resources: www.healthcare.gov/preventive-care-adults/: information regarding coverage under the ACA www.cdc.gov/prevention/: a tool/checklist for preventive care needs based on age and sex, with links to other preventive health information www.honoringchoices.org/resources/: links to the Honoring Choices form for advance care planning

Many preventive care items are now covered under your insurance plan.

SUNFLOWER SPREAD

www.cdc.gov/vaccines/: immunization guidelines, schedules, and frequently asked questions Dania Kamp, MD, FAAFP, is a family physician at Gateway Clinic in Moose Lake, Minn. She currently serves as president of the Minnesota Academy of Family Physicians.

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Boost your grade

Health literacy from page 15

5. Streamline processes within the health care system. Productive

partnerships within the health care system could identify and implement effective strategies and actions to lessen the burden on patients to navigate the fragmented health care system. 6. I nvest in language and cultural resources. Because limited English

proficiency has a profound impact on health literacy, health care organizations need to take language and cultural differences into account when providing health information. Going forward This action plan is intended to guide efforts across the industry, and to serve as a tool for organizations and professionals throughout the broader health community. The 43 cosponsors of the plan have agreed to prioritize and implement strategies that are appropriate for their organizations. The organizations will reconvene during Health Literacy Month in October 2016 to discuss implementation efforts and opportunities to further collaborate.

All patients…prefer easy-to-understand health information.

Concerned about your health literacy? Here are some tips to prepare for your next appointment. Be prepared. Create a written list of concerns. Ask questions. Take charge of your health care. Make sure that you cover all of your written concerns, and ask follow-up questions. Make sure you understand. Ask about anything that is unclear. Repeat what your doctor says in your own words, take notes, and bring a friend with you if necessary. If you still do not understand, ask again. Don’t be embarrassed, and don’t worry about appearing confused. Know the answers to key questions. Before you leave, be sure you have answers to these three questions: • What is my main problem? • What do I need to do? • Why is it important for me to do this? Do your homework. Good information leads to good choices. You’ll find a wealth of information online, but focus on reliable sources, including: • MedlinePlus.gov, hosted by the National Institutes of Health with content from the National Library of Medicine • Healthfinder.gov, hosted by the U.S. Department of Health and Human Services with consumer-oriented prevention and wellness information.

Alisha Ellwood Odhiambo, MA, LMFT, chairs the Minnesota Health Literacy Partnership and is a senior provider quality program manager in quality and health outcomes at Blue Cross and Blue Shield of Minnesota.

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

May 2016 Survey 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 is meant by the term “genomic medicine.” 50 50

2. I believe the decoding of the human genome will lead to significant advances in medical science. 60 60

40 40

3. I believe my decoded genomic sequence should be part of my permanent medical record. 40 40

50 50 30 30

40 40

30 30

30 30

20 20

20 20

20 20

10 10 00

00

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

4. I believe that genomic data should be collected at birth. 50 50

Agree

No opinion

Disagree

Strongly disagree

5. I would consent to have my genomic data aggregated anonymously into scientific research.

40 40

30 30

32

Strongly agree

50 50

40 40

30 30

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20 20

10 10

10 10

00

10 10

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00

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MINNESOTA HEALTH CARE NEWS JUNE 2016

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

00

Strongly agree

Agree

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 JUNE 2016 MINNESOTA HEALTH CARE NEWS

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Bicycle safety from page 13

texting, or intoxicated, for example) because it can prevent you from seeing dangerous situations in time to avoid them. Hazards for bicyclists are slightly different than for motorists. Bicyclists should watch for broken glass that can puncture tires, loose gravel that can cause skidding, potholes, uneven road surfaces or railroad tracks that can cause loss of control, parked motorists opening car doors into bike lanes, and more. Common injuries resulting from these types of hazards include scrapes and abrasions (“road rash”), broken limbs, head injuries, and more. It’s important to note that most crashes on bikes are simply falls that can be avoided by being attentive to road conditions and not riding too close to the shoulder of the roadway.

broken on impact, or something else doesn’t feel right, the bicyclist should strongly consider visiting the emergency room. Minnesota fares better than many states in fatality rates stemming from accidents between cars and bicycles. A 2014 report issued by the Governors Highway Safety Association reported a nationwide increase in such fatalities, but the Minnesota Department of Transportation reports a decline here at home. All uphill Bicycling in Minnesota grows more popular every year. On average, there are 5,000 riders each day year-round on the Midtown Greenway. Bicycling has increased by 33 percent in St. Paul and 73 percent in Minneapolis over a seven-year period, and 15 percent more women are riding now than in 2008. About 50 percent of Minnesotans ages 18 and up ride a bicycle at least once a month. As people become more aware of the benefits of active transportation, such as biking or walking, these numbers will continue to rise. However, we must all come together to follow the law, take safety precautions, and be aware of hazards to ensure that we all remain safe—no matter what our mode of transportation.

Bicycling has increased by… 73 percent in Minneapolis over a seven-year period.

In the event of an accident between a car and a bicycle, all parties should remain calm and follow the same procedures that one would if it was a vehicle-on-vehicle crash. The police should be called, even if injury or damage is minor, to get the incident on record. The motor vehicle driver should provide the bicyclist with their insurance information, address, phone number, and license plate number. Take pictures of the scene if anyone around has a camera or smart phone. The bicyclist in the crash should consider that their adrenaline is pumping, which could be masking physical pain. If there are physical wounds, the bike helmet was

Thomas E. Kottke, MD, MSPH, is medical director of well-being at HealthPartners. Jo Olson is communications manager at the Bicycle Alliance of Minnesota.

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We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health. Whether you have experienced any type of cardiac event, are at risk for one, or

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MINNESOTA HEALTH CARE NEWS JUNE 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

MN Health Care News June 2016  

Vol.14 No.6 Individualized medicine: Health care at the genetic level By Keith Stewart, MD, Mayo Clinic Center for Individualized Medicine...

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