MN Healthcare News Jan 2016

Page 1

January 2016 • Volume 14 Number 1

Cholesterol Management Elizabeth Klodas, MD, FACC

Multiple Sclerosis Jessica Stulc, MD, MPH

Corneal Abrasions Michael V. Dieter, OD


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

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Minnesota Health care news January 2016


CONTENTS

4 7 8

JANUARY 2016 • Volume 14 Number 1

16

News

Elder care

The Green House Project Improving quality of life

PEOPLE

PERSPECTIVE Ken Kephart, MD Honoring Choices Minnesota

By Deb Veit

18 20

12

10 QUESTIONS Philip David Zelazo, PhD University of Minnesota Institute of Child Development

Preventive Health

Cholesterol management Promise and peril By Elizabeth Klodas, MD, FACC

14

Neurology

Headaches Types, causes, and treatments

22

Forty-FIFtH SESSIon

cALENDAR

Neurology

Multiple sclerosis Improved treatment options

By Jessica Stulc, MD, MPH

10

MInnESotA HEALtH CArE roUnDtABLE

Long-term care Family advocates A look at an important emerging role

Medical Innovation vs. Medical Economics When payment policies limit quality of life

By Suzanne M. Scheller, JD

26

Corneal abrasions A painful but treatable condition

By Michael V. Dieter, OD

28

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

Optometry

Pediatrics

Head lice A common annoyance

By Rebecca Doege, MD

By Rohaan F. Mehta, MD

Publisher Mike Starnes | mstarnes@mppub.com Editor Lisa McGowan | lmcgowan@mppub.com Associate Editor Richard Ericson | rericson@mppub.com Acquisitions Editor Patricia Mata Starnes | tmata@mppub.com Art Director Joe Pfahl | joe@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com Account Executive Stacey Bush | sbush@mppub.com Account Executive Kylie Engle | kengle@mppub.com Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc.

Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.

Downtown Minneapolis Hilton and Towers Background and Focus: The pace of innovation in medical science is rapidly escalating. From more accurate diagnostic equipment, to the use of genomic data, to better surgical techniques and medical devices, to new and more efficacious pharmaceuticals, breakthroughs occur nearly every day. These advances face many challenges when incorporated into medical practice. Several significant factors limit this adoption, including the economic models around how patient use of new science will be utilized. Twentieth century health insurance, medical risk management, and reimbursement models are controlling 21st century medical care and patients are the losers. Objectives: We will review examples of recent scientific advances and the difficulties they face when becoming part of best medical practice, despite their clear superiority over existing norms. We will look at prevailing thinking behind economic models that govern how health care is paid for today. Our panel of industry experts will explore potential solutions to these problems. We will look at ways to create balance between payment models, new technology, and increased quality of life. Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable. Name Company Address City, State, ZIP Telephone/FAX Card #

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January 2016 Minnesota Health care news

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News

Minnesota Gets High Marks on State Health System Scorecard

scorecard shows that more states improved than worsened on the majority of the 42 indicators.

“Gains reported by the scorecard likely reflect the influence of Minnesota has ranked first on public policy—most noticeably, the 2015 state scorecard on state the role of the Affordable Care health system performance from Act in expanding health insurance the Commonwealth Fund. It tied with Vermont for first, followed by coverage—as well as public and private initiatives at the national, Hawaii, Massachusetts, and a tie for fifth among Connecticut, New state, and community levels,” according to the report. “States have Hampshire, and Rhode Island. many opportunities to widen these This is the fourth such scorecard, with previous versions published in gains in various ways—purchasing 2007, 2009, and 2014. Minnesota health care for low-income Medicaid populations and state employalso ranked first in 2014. ees, establishing rules that guide To create the scorecard, rehealth care and insurance markets, searchers analyzed the most recent setting strategy for health infordata available for 42 indicators mation technology and exchange, grouped into five domains—access supporting public health, and actand affordability, prevention and ing as conveners and collaborators treatment, avoidable hospital use in improvement with other health and cost, healthy lives, and equity. care stakeholders.” Minnesota is the only state to Minnesota did well overall, score in the top quartile on all five but there were some categories measures. in which it ranked very low. For Mississippi was the lowest per- example, the state ranked 45th in forming state, followed by Okla“home health patients who get bethoma, Arkansas, Louisiana, and ter at walking or moving around” Alabama. Overall, however, the

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Minnesota Health care news January 2016

and 47th in “home health patients whose wounds improved or healed after an operation.” It also ranked low in “children with a medical and dental preventive visit in the past year,” dropping to 48th when the category applied to children in families with low income. According to the authors, if Minnesota were to improve to the level of the best performing state in each category, 97,174 more adults would be insured, 82,453 fewer adults would go without needed health care because of the cost, and 13,286 fewer emergency department visits would occur among Minnesotans with Medicare.

Minnesota’s Occupational Safety and Health Administration (OSHA) division issued the citation and fine notification on Dec. 4. The citation includes nine “serious” safety violations at the hospital between May 10 and July 13. OSHA defines a “serious” violation as one “where death or serious physical harm has resulted or would reasonably be expected to result from an employee’s exposure to a violation.” Each violation incurred a $7,000 penalty, the maximum allowed by law. The citation followed OSHA’s surprise inspection at the hospital in July. DHS has a 20-day window to contest the fine.

Carol Olson, DHS’s executive director for forensic services at the hospital, said in a statement that more work needs to be done to improve safety at the hospital. “The Bureau of Mediation Services The Minnesota Department of is currently leading a process on Human Services (DHS) has been campus that brings together emissued a $63,000 fine for failing to ployees and other stakeholders to protect staff from patient assaults develop solutions to safety issues at at the Minnesota Security Hospital the facility,” she said. “Additionalin St. Peter. ly, the department will be working

OSHA Fines State for Violations at Psychiatric Hospital


with lawmakers in the upcoming legislative session to make additional safety improvements, including key upgrades to facilities at the Minnesota Security Hospital, which will be an essential component of that effort.”

Invoicing Issues Cause $44 Million Loss in Minnesota­ Care Premiums State officials have found that problems with the MNsure invoicing system have resulted in Minnesota losing more than $44 million in revenue from MinnesotaCare premiums. That amount is more than 60 percent more than the $27 million loss the state predicted last year. The amount increased due to ongoing problems with MNsure’s system. About 110,000 Minnesotans pay premiums between $0 and $80 per month for the public health insurance program, depending on income. Those premiums cover less than 10 percent of total costs to run the program. “We have the appropriations to run the program,” the Department of Human Services said in a statement. “However, we are certainly concerned about the issues with the billing system and the significant loss of revenue to the state.” As of July, about 55,000 MinnesotaCare enrollees were not receiving invoices for their premiums. That number was reduced to about 10,000 cases in September. The state plans to begin a reconciliation process in 2016 to collect unpaid premiums and will allow payment plans for those who owe multiple payments. The invoicing issues will not affect their access to health care in the meantime. It has been about a year since state officials became aware of the invoicing problems. They decided this past summer to stop attempting to fix the issue with MNsure’s system and to switch back to the system it used previously. It will cost about $850,000 to update the new system, which the state plans to move to in January.

Dayton Appoints New Human Services Commissioner Gov. Mark Dayton has named Emily Johnson Piper, JD, general counsel and deputy chief of staff in the Office of Gov. Mark Dayton and Lt. Gov. Tina Smith, as the new commissioner of the Minnesota Department of Human Services.

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“Emily Johnson Piper will be an outstanding human services commissioner,” said Dayton. “Emily’s exceptional judgment, her integrity, and her commitment to excellence in all she does, are the foundations for her success. As general counsel, she has been deeply involved in the most significant issues affecting the department. Thus she is well-prepared to provide the same outstanding leadership to that agency, as did her predecessor, Judge Lucinda Jesson.” Johnson Piper’s previous experience includes serving as deputy commissioner and chief of staff in the Minnesota Department of Commerce as well as positions practicing law in both the private and public sectors in the areas of insurance, health care, human services, and employment. She earned her juris doctorate at the University of St. Thomas School of Law. She will step into the role on Dec. 14.

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Johnson Piper replaces Lucinda Jesson, who Dayton appointed to the Minnesota Court of Appeals in early December along with Tracy Smith, deputy general counsel for the University of Minnesota. Jesson served as human services commissioner since Dayton appointed her to the role in 2011. Jesson and Smith will replace Judge Natalie Hudson, who was appointed to the Minnesota Supreme Court earlier this year, and Judge John Smith, who will retire in February. “Public service has been the cornerstone of my career, from my work as chief deputy in the Hennepin County Attorney’s Office to being commissioner of the Minnesota Department of Human Services,” said Commissioner Jesson. “I am grateful for this new opportunity to serve the people of Minnesota.” News to page 6

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H2462_92682 Accepted 10/14/2015 HealthPartners is a Cost plan with a Medicare contract. Enrollment in HealthPartners depends on contract renewal. ©2015 HealthPartners

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News from page 5

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Summit Orthopedics Announces Woodbury Expansion Plans Minnesota Maintains Summit Orthopedics has anLead on Physician nounced finalized plans to expand into Woodbury’s Bielenberg Sports Quality Transparency Center, following the Dec. 9 approval of a lease agreement by the Woodbury City Council. The plan includes a two-story, 14,450-square-foot clinic and wellness center space in the building offering physician appointments, physical therapy, and sports performance services, as well as wellness educational classes on topics such as yoga and nutrition. The city’s original plans for the Bielenberg Sports Center included space for a restaurant and for the Minnesota United Football Club, the state’s professional men’s soccer team. However, those plans were canceled and now Summit Orthopedics will occupy the space they have left vacant.

Massachusetts and Wisconsin received a “C” and Missouri, New Mexico, and Ohio received “D” grades. The remaining 40 states received a failing grade.

For the third year in a row, Minnesota received an “A” grade on the State Report Card on Transparency of Physician Quality Information from the Health Care Incentives Improvement Institute. It was one of only three states to receive the highest letter grade, and it is attributed to the state’s Minnesota Healthscores website.

“While there is some progress, all of the states with a failing grade last year received the same this year,” said Francois de Brantes, executive director of the Health Care Incentives Improvement Institute. “That means the vast majority of Americans simply don’t have access to local information on the quality of physician care. There is, however, the potential for significant progress in the next year and we’re doing our part to make it happen.”

Washington also maintained its “A” grade from last year, and California improved its performance from a “B” in 2014 to an “A.” Only one other state received a different letter grade from 2014: Oregon, which improved its performance from a “D” in 2014 to a “C” this year. Maine was the only state to receive a “B.”

The grades are based on the number of primary care and specialty care physicians for whom health care quality information is publicly available and on the ease of access to that data. Analysts used the Robert Wood Johnson Foundation’s national directory for comparing health care quality as a starting point for the review.

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Minnesota Health care news January 2016

The report notes some exceptions, which are the same as they were in 2014. “The community-wide programs in Detroit, Cincinnati, Cleveland, and Kansas City continue their hard work of providing physician quality of care information,” the report says. “And the same is true for the statewide efforts in Maine, Massachusetts, California, Colorado, Washington, Oregon, New Mexico, Minnesota, and Wisconsin. While the focus of most of these efforts is on primary care physicians, what they measure often matters a lot to consumers, including how well these physicians can take care of chronic conditions.”

Correction The article on pulmonary rehabilitation appearing in our December 2015 issue omitted the name of author John Henricksson. We regret the error.

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


People Brian Sick, MD, internist and pediatrician at the University of Minnesota Medical Center’s Primary Care Center, has received the Early Distinguished Career Alumni Award for his accomplishments. Since 2007, Sick has served as medical director of the Phillips Neighborhood Clinic, a free, student-run clinic where students of medicine, denBrian Sick, MD tistry, nursing, pharmacy, physical therapy, public health, and social work provide care to more than 1,100 underserved patients per year. He is also an assistant professor at the Medical School where he is responsible for the Academic Health Center’s interprofessional education curriculum. Sick earned his medical degree at the University of Rochester School of Medicine in New York and completed a dual residency in internal medicine and pediatrics at the University of Minnesota. Marilyn Peitso, MD, pediatrician with CentraCare Health in St. Cloud, has received the 2015 Betty Hubbard Maternal and Child Health Leadership Award from Minnesota’s Maternal and Child Health Advisory Task Force and the Minnesota Department of Health for her leadership and advocacy on behalf of mothers and children in MinneMarilyn Peitso, sota. Peitso is a longtime member of the Minnesota MD Medical Association (MMA) and currently serves on its board of trustees and on the MMA Foundation’s board of directors. She is also on the state’s Health Care Financing Task Force and she previously served as president of the Minnesota Chapter of the American Academy of Pediatrics. She earned her medical degree at the University of Minnesota Medical School and completed her internship and residency at University of Iowa Hospitals and Clinics. James Standefer, MD, adjunct professor of ophthalmology at the University of Minnesota, has received the 2015 International Blindness Prevention Award from the American Academy of Ophthalmology (AAO) in recognition of his work helping to prevent blindness on a global scale. He has been a member of the AAO for 45 years and was chairJames Standefer, man of its International Educational Development MD Committee for eight years. After 25 years of treating patients at a private practice, Standefer left to volunteer full time, performing cataract surgery and working as a clinical and surgical ophthalmologist across the world. He also developed and taught courses on glaucoma diagnosis and treatment for practitioners in developing countries. Standefer earned his medical degree at Weill Cornell University Medical College in New York City and completed his residency at Washington University in St. Louis, Mo.

Kenneth Ripp, MD

Kenneth Ripp, MD, family medicine physician at Raiter Clinic in Cloquet, has received the Lake Superior Medical Society Alliance’s 2015 Physician of the Year Award for his consistent demonstration of “qualities that patients and physicians recognize as defining medical excellence in medical care delivery.” Ripp earned his medical degree from the State University of New York Upstate Medical University at Syracuse and completed his internship and residency at St. Joseph’s Hospital Health Center.

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P e r sp e c t i v e

Advance Care Planning Making your wishes known

A

Ken Kephart, MD Honoring Choices Minnesota Dr. Kephart is the medical director for Honoring Choices Minnesota — an initiative of the Twin Cities Medical Society — and the medical director for Fairview Health Geriatric Services.

dvance care planning. Living will. Health care directive. Surrogate decision-maker. Have you heard these terms? Have you talked with your health care provider and your family about what you would want if you were ever unable to communicate? The New Year might be the ideal time to start such a dialogue, aided for some by new Medicare/Medicaid regulations taking effect in January 2016.

Start the process

Facing the future

Talk with your loved ones. Think carefully about whom you want to name as your Agent (legally appointed surrogate decision-maker), as the best choice is often not the first person who comes to mind. Share your thoughts and fears with them, ask if they are willing and able to take on the role of Agent, and look through the directive together.

Many people think Advance Care Planning (ACP) is only for people who are really old or who are facing a chronic, serious disease. The truth is, life can change in an instant. If you were in an accident, or had an unexpected health crisis like a heart attack or stroke that placed you in the hospital, unable to communicate, would your loved ones know what types of care you would want? Research tells us that many people do think about it but never take the next steps—they never talk about it with their loved ones or write it down in a health care directive. We also know that, of the people who do talk about and write down their wishes, only a few share their preferences with their doctors. Thankfully, this is changing, for a variety of reasons:

• As people become aware, they realize they have the right to state their preferences, and that health care providers will listen. • Health care providers are becoming better educated on how to help people plan for the future, in schools of medicine and nursing, and as staff in hospitals and clinics. • Starting in January 2016, more opportunities for ACP discussions between individuals and their doctors (and other qualified health professionals) will be available due to new payment codes approved by the Centers for Medicare & Medicaid Services. Ask your clinic for an appointment to talk about ACP.

Minnesota Health care news January 2016

Learn more. Search online for background on ACP or download a free health care directive. In addition to your own health care provider’s website, visit the Honoring Choices site (www. HonoringChoices.org) for background information, resources, and a health care directive that meets all Minnesota statutory requirements.

Pick up the phone. Call your clinic and tell them you would like an appointment to discuss ACP. Every system will have a slightly different way of processing that request, but it’s important that you talk about and share your directive with your providers. Ask for their input on any questions that you have or situations you are unsure about. Listen to their guidance about how best to describe your thoughts and wishes. And remember to leave a copy with them to be added to your medical record.

Decide who you want to speak for you if you are unable.

• National and regional awareness about this topic is increasing, with a growing number of organizations and publications raising interest and understanding of the importance of ACP. Among the voices: Atul Gawande, MD, MPH, author of “Being Mortal”; The Conversation Project, started by Ellen Goodman; the Respecting Choices Program in La Crosse, Wisc.; and Honoring Choices Minnesota.

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If you are ready to begin:

Goals and gifts

The goals of ACP are to decide who you want to speak for you if you are unable, to think about scenarios that many people prefer to avoid, to talk about possibilities with the people who are important in your life, and, ultimately, to write your wishes down and share that information with your doctor. Thinking it will never happen to you is short-sighted. It’s much better to face the initial discomfort of talking about these types of situations, especially since the vast majority of people say afterwards that they are so glad they did. ACP is a gift to your family. If and when a medical crisis strikes, think about how much easier it will be for your loved ones and caregivers to be able to say “We talked about this. I know what she wants,” instead of having to guess. Two sayings to keep in mind are: it’s always too soon until it’s too late, and your caregivers can’t follow your wishes if they don’t know what they are. For more information or assistance, contact Honoring Choices Minnesota by phone at (612) 3623705 or by email at info@HonoringChoices.org.


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10 Questions

Executive function: Developing lifelong skills Philip David Zelazo, PhD Dr. Zelazo is the Nancy M. and John E. Lindahl Professor at the University of Minnesota’s Institute of Child Development Please explain what neurobehavioral development means. This term refers to changes in children’s thinking and behavior that are related to corresponding changes in their brains. Consider, for example, executive function (EF) skills, a set of cognitive skills required for goal-directed problem solving. The development of these skills is closely tied to the formation and refinement of neural circuits involving the front third of the brain, called the prefrontal cortex. Both behavior and brain develop as a function of experience: As children acquire new skills, the neural circuitry needed for those skills becomes more efficient, more reliable, and more likely to be activated in the future. I like to say that we grow our brains by using them, and we grow our brains in particular ways by using them in particular ways. EF skills allow us to actively and intentionally control our attention in order to accomplish a goal, such as keeping a question in mind in order to formulate an answer. This is typically measured as three skills: cognitive flexibility (thinking about something in multiple ways—for example, considering someone else’s perspective on a situation), working memory (holding information in mind so it can be used to guide behavior), and inhibitory control (ignoring distractions and inhibiting impulsive responses). In addition, executive function (and the specific brain regions involved) varies depending on the emotional significance of the situation, from more “cool,” cognitive EF to more “hot,” emotional EF. Hot EF is typically assessed in tasks that require one to be flexible in deciding whether to approach or avoid a meaningful stimulus. A classic example of hot EF is delay of gratification: avoiding a smaller but tempting immediate reward and waiting instead for a larger but delayed reward.

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Minnesota Health care news January 2016

What are some of the methods you use to study problem-solving skills? We rely on reliable and validated procedures that measure children’s EF skills directly. An example is the Minnesota Executive Function Scale (MEFS), which is a brief (four minute), standardized, tablet-based assessment designed for children age two and up. Presented as a fun, engaging game, the MEFS adaptively measures the proficiency of children’s EF skills, and scores are compared to national norms. Using measures like the MEFS, we have been able to chart the development of EF skills across the lifespan, and examine changes in EF skills in relation to measures of children’s brain function (e.g., recording neural activity using an electroencephalogram). We have also examined the efficacy of interventions designed to promote EF. At what age do children begin to exhibit decision-making and problem-solving skills? EF skills emerge in infancy, undergo substantial and rapid changes during the preschool years (from about two to five years), and continue to improve until young adulthood (about 25 years). The development of EF skills closely tracks the development of the brain’s prefrontal cortex. In infancy, children demonstrate EF skills when they search for hidden objects, which involves keeping a goal in mind and using it to organize one’s behavior. When objects are hidden first in one location and then in another, infants must keep the new location in mind and avoid getting distracted by the old location. Does genetics play a role in executive functioning? Genes play an important role in EF and its development, as they do in all behavior. For example, there is evidence that genetic variations affecting the efficiency of dopamine (a key neurotransmitter) are correlated with EF across samples and ages. The effects of these genetic variations on a given child’s EF skills likely depend on the kind of environment that child grows up in, as well as on external or environmental (epigenetic) mechanisms that regulate gene expression. While genes play a role in EF, it is also clear that interventions targeting EF skills can improve those skills and produce corresponding changes in brain structure and function. How can parents help their young children to develop problem-solving skills? Parents can provide children with age-appropriate support during problem solving, like nudging the correct piece of a puzzle into a young child’s view so that


the child can “discover” it herself. This type of support (just enough, not too much) helps keep children exercising their EF skills—it keeps them appropriately challenged and it keeps them motivated to solve problems in the future. Children develop their EF skills by using them. Parents can also describe their own behavior in terms of EF skills, they can point out when children are using EF skills, and they can encourage and support the exercise of these skills. This can be done in the course of everyday activities (e.g., forgoing candy in the checkout aisle for the opportunity to play a game later). Many traditional childhood games (e.g., Simon Says, Red Light/Green Light, musical chairs) challenge children’s EF skills, which is what make them fun. Parents can play games like these with their children and adjust the difficulty to make the games appropriately challenging. For example, Simon Says is easier if children are instead asked to follow the instructions of one puppet and ignore the instructions of another.

How do cultural differences impact the development of problem-solving skills? Too little is known about this. It is clear, however, that even within our own country, differences in parent education, family income, and specific parent practices are correlated with differences in children’s EF skills, and also that specific interventions can promote the development of these skills. We would, therefore, expect better EF skills in children who grow up in cultures or contexts that value EF skills and provide children with more opportunities to develop and practice those skills.

We grow our brains by using them.

How does your work benefit children with conditions such as autism or ADHD? Difficulties with EF are prominent features of a variety of conditions, including ADD/ADHD, Autism Spectrum Disorder, Conduct Disorder, and Obsessive Compulsive Disorder. Advances in our understanding of EF (e.g., the distinction between hot and cool EF) and in the validity and sensitivity of our measures (e.g., the MEFS) help us to characterize which aspects of EF are implicated in which conditions. In addition, the interventions we have developed for promoting EF skills in childhood have considerable potential for the neurorehabilitation of disordered or delayed prefrontal function, regardless of the source of the problems.

Do these skills change as the brain ages? Sadly, yes. Research using the NIH Toolbox (Zelazo et al., 2014) indicates that EF skills typically reach maximum proficiency in early adulthood (about 25 years), and then generally decline with age. What resources are available for people hoping to learn more? I recommend the Harvard University Center on the Developing Child (http://bit.ly/1P5ENyX), About Kids Health (http://bit. ly/1QVSMb8), The Washington State Department of Early Learning (http://bit.ly/1xE65F7), and Vroom (http://bit.ly/1Nz8Dfw). What are the most important steps we can take to keep our brains functioning at top capacity? Practice, practice, practice. Like any skill, EF skills, and the brain circuits on which they depend, quite literally need to be exercised to continue to function efficiently. There is evidence that elderly adults can improve their EF skills considerably through practice (e.g., in the context of a video game that challenges attention). But EF skills are also exercised whenever we learn new things and take on new challenges.

Now accepting new patients

A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures. Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.

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

are interested in learning how to prevent one, we can design a set of just-for-you solutions. Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions

To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com January 2016 Minnesota Health care news

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Preventive Health

Cholesterol

management Promise and peril By Elizabeth Klodas, MD, FACC

E

levated cholesterol levels in the blood have long been known to increase the risk of developing heart and vascular disease, including stroke. And lowering of cholesterol has been shown in multiple studies to reduce that risk. Millions of patients lower their cholesterol levels with medication, including statins and a newer drug group just approved for consumers. All medications carry some risks, however, and many find dietary changes to be an effective means of managing cholesterol.

Statins: daily cholesterol control When it comes to medications, the main way to lower cholesterol is with statin drugs. Statins include Lipitor (atorvastatin), Zocor (simvastatin), Pravachol (pravastatin), Mevacor (lovastatin) and Crestor (no generic form currently available). Based on the latest cholesterol treatment guidelines, 70 million Americans are candidates for statin therapy. Statins inhibit a liver enzyme called HMG-CoA reductase. When this enzyme is inhibited, cholesterol production in the liver slows down. When cholesterol production in the liver falls, circulating levels of LDL (bad) cholesterol drop, reducing health risks. In general, at maximum dose, statins can lower LDL by 30 to 50 percent and lower the risk of heart attack or stroke by as much as 30 percent. It’s no wonder so many people receive a prescription for one of these drugs. Although the vast majority of people do well on statins, these medications are not without side effects. Here are the four main side effects that you should be aware of:

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1) Liver. Statins work in the liver, where they’re only supposed to affect the HMG-CoA reductase system. But in 1 to 3 percent of people, statins have a broader liver effect that translates into elevated liver enzyme tests. You can’t feel this effect, but it is something that will show up in a blood test. The liver effect, if it occurs, is seen early after starting a statin or increasing the dose. It is also almost always reversible and blood tests return to normal quickly once you stop the statin medication. 2) Muscle. Muscle side effects are the most common reason people stop taking statin medications. Although very few patients experienced muscle side effects during the clinical trials that led to approval of the medications, in real-world practice, about 10 to 20 percent of patients taking the medications report achiness. The achiness tends to affect large muscle groups and tends to be symmetrical. Patients tend to complain of back pain or bilateral leg pain or shoulder/upper arm pain. The achiness may be felt more in the joints than in the muscles, but still tends to affect larger joints— and usually on both sides of the body.

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Minnesota Health care news January 2016


The achiness can vary in severity from person to person. For some people it’s very subtle—it just takes them longer to recover from strenuous exercise. For others it’s much more extreme and actually interferes with their ability to move without pain. The reason why some people develop muscle side effects and others don’t is not known, although certain medication combinations can make achiness more likely. One thing is clear: the higher the statin dose, the more likely the muscle achiness. So minimizing the dose you need helps reduce your chances of developing muscle side effects. The good news is that achiness caused by a statin tends to go away very quickly once the medication is stopped. People usually report marked improvement within two to four weeks of stopping the drug. Unlike liver side effects, muscle side effects do not necessarily appear right away. Instead, they tend to appear sometime during the first six months of starting the medication (or increasing the dose). But some people are on statins for well over a year before they notice this side effect.

receptors increases, allowing more LDL to get removed from the blood stream. In other words, if PCSK9 is inhibited, LDL levels fall. Praluent and Repatha are not pills. They need to be injected once to twice per month (as you might self-inject insulin). But even though they’re not taken every day, they are extremely effective in lowering LDL (by as much as 70 percent). They also don’t seem to make people achy. It’s no surprise many doctors are excited about the availability of this option. But a few caveats. Although these medications are very effective in lowering LDL, there is no definitive data—yet—that these drugs actually lower the risk of heart attack and stroke. Chances are high that they do, but it has not been proven to date.

Statins are very effective for the majority of people.

3) Brain. Neurologic side effects are rare, but can occur. People tend to report fogginess, being “less sharp” or more forgetful. This again tends to reverse with stopping the medication. It’s important to point out that, on balance, published studies have shown that statins appear to be somewhat protective against dementia. This is probably because people on statins have lower rates of stroke. 4) Diabetes. The association between statin therapy and a higher risk of developing diabetes is something that has only recently been appreciated. The reason for this association is not understood, but it does not appear to be entirely explained by background lifestyle factors. In other words, there is something unique to statins alone that is driving higher rates of diabetes in statin users. The risk of diabetes is higher with higher doses of statins used. The general consensus is that the cardiovascular benefits of statins far outweigh the diabetes risk. However, if you are on these medications you should address any other risk factors you have for developing diabetes, especially excess weight. A statin alternative It’s clear that although statins are very effective for the majority of people, they are not perfect medications, and alternatives have been sought for a long time. And now, some 30 years after statins first entered the marketplace, a new group of medications has been approved by the Food and Drug Administration (FDA): PCSK9 inhibitors. PCSK9 inhibitors (like Praluent and Repatha) represent a whole new category of drugs. They are very different from statins and lower LDL cholesterol by neutralizing a substance called PCSK9, a protein that controls the number of cholesterol receptors in the liver. If PCSK9 levels are lowered, the number of liver cholesterol

Side effects appear to be uncommon, but we won’t really know that until many more people use the drugs for a more extended period of time. Remember, the muscle side effects of statins were not really seen during the clinical trials that led to their approval. But achiness has become a major obstacle for people using statins in clinical practice. Cholesterol management to page 19

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(320) 763-8888 www.tristatebrainspine.com January 2016 Minnesota Health care news

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Neurology

Headaches Types, causes, and treatments By Rohaan F. Mehta, MD

P

ain that is persistent or occurs repeatedly can be very distressing. Headaches have the added, dubious distinction of being especially debilitating for many people. Although there are numerous types of headaches, the most frequent are tension, migraine, cluster, and chronic daily headaches. A person may suffer from more than one type, requiring separate types of treatment. Types of headaches Tension-type headaches. Often triggered by stress or tension, these headaches usually affect both sides of the head, and may include the neck. Patients may feel pressure or constriction, as well as tenderness of the muscles of the head and neck. Tension headaches usually do not include nausea, vomiting, sensitivity to light or sound, numbness, or weakness, unless the person also suffers from migraine headaches.

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Migraine headaches. Some 12 to 16 percent of Americans suffer from migraine headaches, which may be triggered by food and drink; strong sensory inputs such as bright or flashing lights, odors, or loud sounds; hormonal status, including menstrual periods; stress; environmental factors; changes in diet, sleep, meal times, or physical activity; or medications, including birth control pills, nitroglycerin, and hydralazine. Migraines usually affect only one side of the head, but may affect both. About 20 percent of people experience “aura” symptoms for 20 minutes to one hour before the headache begins. Aura symptoms are usually visual, such as flashing lights. Other symptoms include numbness, tingling, weakness, or speech difficulties. A person who experiences such symptoms for the first time should seek medical attention to rule out more serious medical conditions. Migraines produce throbbing or pulsating pain that disrupts activity and often causes distress. They usually include sensitivity to light, noise, and motion, causing many to seek dark and quiet rooms, and may also cause nausea, vomiting, runny or stuffy noses, and teary eyes. Migraines can last from several hours to three days.

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Minnesota Health care news January 2016

Cluster headaches. Often affecting people with a family history of cluster headaches, this type of headache always affects only one side, with pain that becomes severe and debilitating within a few minutes of onset and lasts for 15 minutes to three hours. The pain is usually explosive or deep, but may sometimes feel pulsating or throbbing, and may occur several times daily for weeks to months (hence the term “cluster.”) Cluster headaches are associated with redness and tearing of the eye on the side of the headache, a stuffy and runny nose, increased sweating, and pale skin, and are often triggered by consuming alcohol. Secondary headaches. Headaches may be associated with other medical conditions, and call for a medical evaluation to treat the underlying problem. These secondary headaches may be caused by fever, high blood pressure, head injury, head tumors, disorders of the neck, or vision and eye problems, including glaucoma and eye strain. Although sinusitis is often blamed as the cause of headaches, certain studies have found that acute or chronic sinusitis is actually an uncommon cause, and many of these patients actually meet the criteria for diagnosis of migraine.


Chronic daily headache (CDH). This is not a specific type of headache, but rather one or a combination of different types occurring frequently, the most common being chronic tension-type or migraine. About 4 percent of adults worldwide suffer from CDH. One type of CDH is characterized by headaches lasting for at least four hours, affecting the person for at least 15 days monthly for at least three months. The other type of CDH is characterized by shorter headaches that affect the person for at least one year. In either situation, CDH causes significant pain and distress. Medication-overuse headaches. A vicious cycle develops when people suffering from frequent headaches overuse pain medication with increasing frequency. As the medication wears off, this can lead to “rebound” headaches, prompting even more medication use.

smoking cessation, and a regular schedule for eating, sleeping, and exercise. Physical therapy and acupuncture. Performed by professionals experienced in the treatment of headache disorders, these approaches may help some people. Behavioral health therapy. Psychologists and other mental health practitioners can help patients to address stress, depression, anxiety, frustration, anger, and other psychological factors that can both precipitate and be a result of chronic headaches. Behavioral therapy may include individual or group psychotherapy, biofeedback, relaxation techniques, and pain coping strategies.

Twelve to 16 percent of Americans suffer from migraine headaches.

When to see a physician Conditions such infections, tumors, cancer, abnormalities of blood vessels or circulation in the brain, and medical diseases can all produce headaches. To rule out more serious conditions, see a physician if you suffer from headaches associated with these symptoms: • New onset (especially after age 40) • Sudden onset headache that becomes severe within minutes • Worsening or change in frequency, severity, or symptoms • Fever and/or stiff neck • Weight loss • Pregnancy • Conditions that decrease the ability to fight infections, such as cancer, long-term steroid use, or HIV • Decreased alertness, confusion, ability to communicate, fainting, or seizure • New numbness, weakness, or visual difficulties • Head injury • Use or exposure to an illicit drug, toxin, or chemical • Headaches that disrupt sleep • Headaches that start or worsen with coughing, exertion, or sexual activity

Medications. Certain daily medications may be used to prevent the onset of headaches, while others are used only when headache pain (or migraine aura) actually occurs.

Certain anti-depressant medications may prevent some types of headaches, including the most common forms of tension-type and migraine headaches. Beta blockers reduce the frequency of migraine headaches in 60 to 80 percent of people. Anti-seizure drugs and calcium channel blockers also prevent migraines. One calcium blocker (verapamil) has also been shown to be quite effective in preventing Headaches to page 34

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Seek evaluation and treatment if headaches affect your quality of life, work, family, or social relationships. Evaluation and diagnosis Diagnosis starts with a detailed medical history. MRI or CT scans are not essential in most cases, but are warranted if there are concerns about secondary causes such as tumor, head injury, infection, or bleeding. Laboratory study of the cerebrospinal fluid is performed when there is suspicion of bleeding, infection, inflammation, or high fluid pressure. Treatment Your physician may recommend several treatment options, including: Lifestyle changes. The goal is to reduce or eliminate triggers or factors that affect the frequency or intensity of headaches. This may mean limiting or discontinuing alcohol and/or caffeine consumption,

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Elder care

The Green House Project Improving quality of life By Deb Veit

T

he term, “nursing home” has so many negative connotations that many nursing homes have taken to calling themselves “care centers” instead. But under a new model spreading nationally and introduced at one Minnesota facility this year, residents enjoy comfortable, roomy space with daily activities tailored to their needs and interests.

A growing trend The Green House Project is a national movement transforming the quality of life for elders and addressing past concerns about nursing homes. Each Green House home looks and feels like a real home and elders receive four times more care than they would in a traditional nursing home, encouraging residents to socialize and maintain their independence while giving their family members peace of mind. In a 2012 study, The Green House Project examined concerns that most family caregivers have about their loved one living in a conventional nursing home. Among the findings: • Eighty-three percent are concerned about the lack of individualized attention. • Eighty-two percent are concerned with isolation and loneliness. • Eighty-two percent are concerned with the institutional atmosphere. • Eighty percent are concerned with loss of independence. • W hile cost and convenience were factors, they were lower on the list. We all agree that we want the people we love to live in their own homes for as long as they can. But when that is no longer an option, we want them to get the best possible care in a setting that is as close as possible to a real home. What does “as close as possible to a real home” mean in today’s marketplace? There are two ways to look at this question: From a physical plant perspective and from an operational perspective. The physical plant perspective

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Minnesota Health care news January 2016

Architecturally, conventional nursing homes have been designed like mini hospitals with nursing stations and long hallways, shared rooms and baths, and large central dining rooms. No matter how pleasantly decorated these facilities may be, they look and feel institutional. For family and friends, visiting mom at “the home” is very much like visiting mom at a hospital.


Up until 2009, Episcopal Church Home was one such conventional nursing home. The physical plant was a product of its time when it was built in the early 1970s, but times have changed since then, and our leadership and staff recognized that the retiring Baby Boom population would demand more. In 2007, our management and board set about answering the question, “How can we make our nursing home less like an institution and more like a real home?” As options were explored, they found that reimagining the physical plant was inextricably linked to reimagining the model of care. The explorations led to an organization called Action Pact (www. actionpact.com) and the Household Model of Care, which emphasized the value in transforming institutions into home-like facilities built around the daily lives of residents.

When our transition from the conventional nursing home model of care to the Household Model of Care was complete, we thought we had finally achieved nursing home nirvana. Residents who had only pecked at their food in the old central dining room developed healthy appetites in the more homelike surroundings of their household dining rooms. They could rise when they wanted without missing their breakfast. They could bathe when and how often they wished. And they could engage in activities they really cared about. In other words, they got to call the shots much as they always had. Could anything be better than this? The answer turned out to be yes!

The model of care is every bit as important as the physical plant.

To see how this concept worked in the real world, we visited Perham Living, a nursing home in Perham, Minnesota, that had implemented the Household Model of Care under the tutelage of Action Pact. Upon returning from the visit, Marvin Plakut, Episcopal Homes president and CEO, said, “It would be immoral for us not to do this.” In 2008–2009, our facility underwent an 18-month, $11 million transformation. As the physical plant was being divided into six distinct households with 12 to 20 residents per household, the staff was being trained in the Household Model of Care.

The Green House Model of Care In 2012, Episcopal Homes began planning the biggest expansion since its founding in 1894—a $46 million senior living complex that would house three distinct residences. In the first of these—a 60-bed nursing home called The Gardens—each Green House home has 10 residents and two certified nursing assistants (CNAs), as well as one nurse for every two homes. When it opened in early 2015, The Gardens represented Minnesota’s first implementation of the Green House Model of Care. The Green House Project to page 32

Our observation is that some providers stop at the physical plant level and continue to operate their “households” as miniature conventional nursing homes. All staffers have the same titles, roles, and responsibilities that nursing home staffers have always had. “That’s not my job,” is an all-too-common refrain. This underscores the importance of exploring options from the other perspective. The operational perspective If a provider’s goal is to make a nursing home “as close as possible to a real home,” the model of care is every bit as important as the physical plant. The conventional nursing home model of care is “hospital light,” hence intrinsically institutional. All staffers have clearly defined roles and responsibilities. While the provider’s marketing materials may tout being “resident centered,” in reality, every aspect of daily life is organized around the needs of the provider, not the resident. Residents are told when to rise, when to eat, when to bathe, and when to have fun. One size fits all. How homelike is that? The Household Model of Care that we implemented is vastly more “resident centered” than the old model. Daily life is organized around the wants and needs of each household’s residents, individually and collectively. Residents decide when to rise, when to eat, when to bathe, and what kinds of activities (meaningful engagement) they want to engage in. That’s how families in private homes chart their courses, and that’s how the families in each of our households do too. January 2016 Minnesota Health care news

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Calendar Jan.-Feb. 2016 Jan.11

Dementia Friends Training Dakota County Library hosts this class for people who have a friend living with dementia. Come learn the symptoms of dementia and discover small things you can do to make a difference in the lives of people living with this condition. For more information, call (651) 438-0200. Monday, Jan. 11, 6:30–8 p.m., Pleasant Hill Library, 1490 S. Frontage Rd, Hastings

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Tai Chi for Parkinson’s and Wellness HealthEast offers this tai chi class that is designed specifically for people living with Parkinson’s disease to help improve balance, coordination, concentration, strength, and mental well-being. This is a monthly class and there is a $5 per session cost, but the first session is free for beginners. Call Ellen at (651) 232-2166 to register. Monday, Jan. 18, 10–11 a.m., Bethesda Hospital, 7th Flr. Conference Rm., 559 N. Capitol Blvd., St. Paul

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Honoring Choices Fairview Health Services hosts this free class for anyone over the age of 18 who would like guidance planning for their future health care choices. Trained facilitators will help attendees develop an advance care plan and a health care directive. No registration required; other dates are available. For more information, call (612) 672-7272. Monday, Jan. 25, 1–2:30 p.m., Fairview Clinics—Edina, 6545 France Ave. S., Edina

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Newly Diagnosed with Cancer Class Park Nicollet hosts this free education program for individuals who have been recently diagnosed with cancer, their caregivers, family members, and friends. Come discuss changes, stress, and self-care and gain valuable resources to help cope. Other dates are available. Call (952) 9935700 to register. Tuesday, Jan. 26, 3–4:30 p.m., Park Nicollet Frauenshuh Cancer Center, Curtis and Arlene Carlson Family Community Rm., 3931 Louisiana Ave. S., St. Louis Park

Cervical Health Awareness Month An estimated 12,000 women in the U.S. are diagnosed with cervical cancer each year, and about one-third of those cases will be fatal. However, cervical cancer is largely preventable and treatable when it is caught early. Improvements in screening and vaccination have helped reduce the fatality rate by more than 50 percent over the last 30 years. Cervical Health Awareness Month is used to encourage women across the country to get screened for cervical cancer and receive the human papillomavirus (HPV) vaccine if they are eligible. HPV is the most common sexually transmitted disease and the main cause of cervical cancer. In most cases, it causes no symptoms or health problems and is taken care of when a healthy immune system clears the infection. However, a persistent infection, which causes nearly all cases of cervical cancer, occurs in about 5 percent of women. The HPV vaccines that are available today have proven to be almost 100 percent effective in vaccinating against the two strains of HPV that cause about 70 percent of cervical cancer cases. In addition to the vaccine, regular Pap tests are recommended for women ages 21 through 65 to test for precancers (cell changes on the cervix that might become cervical cancer if they are not treated appropriately). Women ages 30 and over may also choose to undergo an HPV test. Both screenings can be performed by a doctor at the same time. Cervical Cancer Screenings The Minnesota Department of Health offers free breast and cervical cancer screenings for eligible women through the Sage Program. Screenings take place at more than 400 participating clinics across the state. Call (888) 6432584 to see if you are eligible and to schedule an appointment.

Feb.9

Better Breathers Club The American Lung Association in Minnesota hosts these free monthly meetings for anyone living with chronic lung disease. Come meet others facing similar issues and learn ways to cope with the challenges that come with chronic lung disease. No registration required. Call Cheryl at (651) 223-9565 for more information. Tuesday, Feb. 9, 1–3 p.m., American Lung Association in Minnesota, 490 Concordia Ave., St. Paul

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Circle of Moms Allina Health offers this weekly support group for pregnant women and new mothers. Come share your experiences, learn new skills, and discuss things that may be difficult to talk about. No registration required. Call (612) 863-0187 for more information. Thursday, Feb. 11, 11 a.m.–12 p.m., The Mother Baby Center, 4th Flr. Celebration Plaza, 902 E. 26th St., Minneapolis

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Child Development Class PACER Center is hosting this free class for parents of children ages two to three who have disabilities. Come learn about the transition process from early intervention services to preschool services, including the requirements and objectives. To sign up, call (952) 838-9000. Saturday, Feb. 13, 9–11 a.m., PACER Center, 8161 Normandale Blvd., Minneapolis

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Easing Chronic Pain Seminar Lupus Foundation of Minnesota offers this class for individuals living with lupus. Come learn why we feel pain and how it travels through the body as well as different strategies to manage pain, including breath work, aromatherapy, and other relaxation techniques. To register, contact Sandy at (952) 746-5151. Registration required by Feb. 16. Wednesday, Feb. 17, 3:30–5 p.m., R.H. Stafford Library, 8595 Central Park Place, Conference Rms. A & B, Woodbury

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.

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Minnesota Health care news January 2016


Cholesterol management from page 13

The one side effect that has already emerged is a slight increase in cognitive dysfunction—that same loss of sharpness that people can experience while on statins. This might become a much bigger concern as experience with these drugs widens. Finally, PCSK9s are very expensive— to the tune of $14,600 per patient per year. That’s not a typo. Given that cost, it is likely that insurance companies will be very selective in granting approval for PCSK9 inhibitor use. A third alternative: diet So what can you do if you have high cholesterol and can’t take statins but don’t want to jump on board for PCSK9 treatment?

The secret? A whole food plant-based diet, rich in fiber, antioxidants, omega-3 fatty acids, and plant sterols (natural plant compounds that interfere with cholesterol absorption in the gut). People eating this way not only have lower cholesterol levels (often as low as those achieved with statin medications), they also tend to be slim and have normal blood sugar levels. They experience low rates of cancer. And they’re not achy. And they tend to stay sharper longer. Sounds like something to be doing even if you need to be on statins or PCSK9s!

Diet contributes significantly to cholesterol levels.

Remember that diet contributes significantly to cholesterol levels. The data on the power of food to lower cholesterol, improve cardiovascular health, and lower rates of heart attack and stroke is actually vast and consistent. In fact, improving lifestyle, and especially food intake, is more impactful in affecting outcomes than any drug or procedure.

Elizabeth Klodas, MD, FACC, is founder of Preventive Cardiology Consultants. In addition to her private practice, she works with several primary care groups including Multicare Associates, Northwest Family Physicians, Catalyst, Williams Integracare, and Entira Clinics. She is also the founder of Step One Foods, a company dedicated to helping people minimize their dependence on prescription medications.

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January 2016 Minnesota Health care news

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9/14/15 9:03 AM


Neurology

Multiple sclerosis Improved treatment options By Jessica Stulc, MD, MPH

O

ne of my patients recently asked, “I’ve been doing so well, do I even have multiple sclerosis?” The fact is that she does. Four years earlier, frightened by symptoms of vision loss that led to her initial diagnosis, she, like many others, imagined a life of disability. Instead, with early diagnosis and treatment, she has had no further clinical symptoms and is living a life she did not imagine possible at the time. Advances in early diagnosis and in available treatments are improving the prognosis for many living

with the disease. The future for MS patients is brighter today than ever before. The body attacks itself A protective sheath, known as myelin, surrounds and protects the body’s nerve fibers, much like the insulation on a wire or cable. MS, a chronic immune-mediated disease of the central nervous system, targets and destroys this fatty insulation in an inflammatory cascade process known as demyelination. There can also be associated collateral damage to the nerve fibers themselves. Damage to these cells prevents nerves from communicating to each other effectively, causing changes in vision, cognition, strength, sensation, and bowel and bladder function. Symptoms will vary depending on where in the brain or spinal cord the damage occurs. MS is an unpredictable disease. Some patients experience periods of time with symptoms (relapses) and periods free of symptoms (remissions). Some 85 percent of individuals with MS experience this relapsing–remitting disease course. During relapses, demyelination results in a rapid onset of clinical symptoms; during remissions, patients can have full or partial recovery from symptoms, with no new clinical symptoms occurring. The severity and the frequency of these relapses are difficult to anticipate and predict. During periods of remission, continued disease activity—despite the lack of symptoms—may still create ongoing nerve injury. If left untreated for many years, about 50 percent of patients with relapsing-remitting disease will transition to a progressive phase of the disease called secondary progressive MS, characterized by a gradual worsening of neurological symptoms. A minority of patients experience this gradual progression without clear relapses at the onset of symptoms, leading to a diagnosis of primary progressive MS.

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MS is diagnosed based on symptoms, the clinical exam, brain imaging, and other diagnostic studies. Areas of demyelination or nerve injury appear as lesions or “plaques” in the brain and spinal cord, which can be seen with an MRI (magnetic resonance imaging). Other studies such as blood work and testing of cerebral spinal fluid may help to confirm the diagnosis and exclude diseases that display similar symptoms. Minnesota Health care news January 2016


Risk factors The exact cause of MS remains unknown, but research reveals multiple interactions between environmental and genetic factors. The disease is twice as common in women, with the typical age of onset between 20 and 50. It is estimated that over 400,000 people suffer from MS. More than 100 genes have been linked to MS. The interaction of these genes is complex, with some providing protection and others increasing risk. We are now on the verge of a new era of “personalized medicine” as researchers attempt to find biomarkers and specific genes that may predict not only risk factors, but a patient’s response to treatment.

is no clear “best” choice for initial treatment, but now patients and their physicians can work to find the “best” choice for them. “Second line” medications are typically reserved for patients with an aggressive disease process or who have had continued clinical progression despite “first line” treatment. These medications generally have increased effectiveness in preventing new relapses or active lesions, but also have increased side effects. For example, natalizumab, which prevents some immune cells from crossing the blood-brain barrier, is very effective, but can increase the patient’s risk of developing a serious and potentially fatal brain infection called progressive multifocal leukoencephalopathy. Most medications in the developmental pipeline show promise for relapsing-remitting MS, but we must be sure we fully understand their long-term risks.

The future for MS patients is brighter today than ever before.

Environmental factors—where you lived in childhood, exposure to infectious mononucleosis, and smoking—can all increase your risk of developing MS. A lack of vitamin D may also be a risk factor, especially in northern regions with reduced exposure to sunlight. The exact mechanism is unknown, but vitamin D does play a role in immune system regulation, and genes related to vitamin D have been linked to MS. In northern U.S. states and Canada, rates of MS are estimated as high as 100 cases in 100,000, compared to rates of 20 to 50 cases in 100,000 for those in the southern states. Minnesota has some of the highest rates of MS in the nation, perhaps due to its Scandinavian heritage and its northern latitude.

Treatment The past several decades have seen a revolution in treatments for relapsing-remitting disease. The first medication for this form of MS was approved in 1993; today more than 13 are available. Since 2010, the U.S. Food and Drug Administration has approved a staggering five new medications, with more in the developmental pipeline. For patients living with progressive MS, however, there continues to be a lack of treatments, and continued research advancements are desperately needed. Medicines used to treat relapsing-remitting MS are termed “disease modifying therapies,” meaning that they change the disease process itself. They target inflammation that contributes to demyelination with the goal of preventing new brain lesions and thereby preventing new clinical symptoms or “relapses.” The rapid development of new medications means that patients now have more treatment options and can focus on finding a therapy that has a benefit-to-risk ratio that is acceptable for their goals and own disease process. “First line” disease modifying therapies can be classified in two main categories: “injectables” and “orals.” Injectable medications such as beta-interferons and glatiramer acetate, which became available in the 1990s, require self-injections biweekly or daily, depending on the medication. Because these medications have been available for many years, their effectiveness and side effects are predictable. For those who cannot tolerate injectable treatments or who find them ineffective, three separate oral medications are also available. Each oral medication has its own risks and benefits. There

Unlike relapsing-remitting MS, there are no acceptable treatments for progressive forms of MS. Disease modifying therapies target active inflammation that causes demyelination, which is less pronounced in progressive forms of the disease. The process that causes progressive MS is less well understood and is characterized by neurodegeneration. Researchers continue to target progressive MS, and in the past year, there has been new data presented on medications that may slow the rate of disability. Multiple sclerosis to page 25

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January 2016 Minnesota Health care news

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Long-term care

Family

advocates A look at an important emerging role By Suzanne M. Scheller, JD

L

ong-term care is an eventuality for many Minnesotans. According to the Minnesota Department of Human Services, the number of people living in nursing homes in Minnesota, not including those in a transitional care unit, is approximately 29,000. The number in long-term care settings other than nursing homes, such as assisted living, is significantly higher. Rough estimates are that well over 100,000 individuals reside in an assisted living, group home, or other long-term care setting in Minnesota. Given the vulnerability and volume of residents, staff alone cannot

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Family involvement Involved family members benefit both residents and providers on multiple fronts. Family members can provide a substitute health care decision maker for older loved ones facing diminished capacity. Family members may transport relatives to the doctor, provide input on their care based on their knowledge of the resident’s medical history, and communicate messages back and forth. Family members provide social interaction and facilitate outings that promote overall quality of life and minimize the depression that often accompanies long-term care. In addition, most family members ensure that bills to the provider get paid. However, long-term care providers may not always embrace the family’s role. If a family member’s voice gets too loud, he or she is labeled as a “detriment” to care; as “interfering” with care; or as a trouble-maker. While there are always outliers who require provider intervention, the vast majority of family members support and speak up appropriately when necessary. As a representative of many vulnerable adults and their families, I label these mainstream family members as “advocates,” and unfortunately providers may bristle at advocates. Advocates need to continue to speak up and providers need to continue to listen, for the good of the elder.

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meet all of the social, physical, spiritual, and psychological needs. The support of family members is key to the resident’s overall quality of life.

Minnesota Health care news January 2016

Effective family advocacy A family member can effectively advocate for their loved one and work with the provider to ensure quality care. In general, there are a few important themes for family advocates to keep in mind: visit the resident; take the time to read documents prior to signing them, even if the facility says that they must be signed right away; document any concerns; and periodically review medical records to ensure that concerns are incorporated and that the records are accurate and complete. All providers must make the admission agreements available to the resident or family member for review. Family members should read admission agreements and resist the urge to simply sign under pressure. Family can ask for one or two days before signing. No signature is actually required for admission.


Many admission agreements now contain separately signed arbitration agreements. I generally recommend that the family/resident not sign any arbitration agreements since the family does not know what dispute may arise when admitting a loved one. By not signing, the family is not precluding arbitration in the future, if both parties agree. The resident will be asked to sign one admission agreement for both housing and care when entering a nursing home. However, in a non-nursing home setting the resident will likely be asked to sign two agreements, one to lease the residence and one for home care services. Family members should read the agreement for home care services carefully to understand items such as: • Valid reasons for discharge;

At the care conference, if the facility asks that each participant sign off on attendance, family advocates should take the time to read over the notes to ensure accuracy and completeness, and to make sure that their concerns are documented. If a family advocate is unable to attend a care conference on a given date or time, they can ask to reschedule and/or participate via phone. Under the Minnesota Health Care Bill of Rights, the resident may choose their own physician, but the family should weigh the factors since using the facility’s recommended “house doctor” may be necessary due to the convenience of the physician coming to the facility for periodic check-ups and regular communication with the facility.

Using the facility’s recommended “house doctor” may be necessary.

• W hether the facility accepts Medical Assistance payments (i.e., Elderly Waiver); • W hether the resident is allowed to bring in their own home care services. Family advocates can be present during the resident’s initial assessment, which generally happens within 14 days of admission. This allows the advocate to understand the resident’s condition when evaluated by a trained professional. Family advocates can participate in care conferences to hear what is being said about their loved one’s progress and/or condition.

Know the Care Plan or Service Agreement under which the facility is providing care. This document dictates what staff will be doing when caring for a resident. If a particular concern isn’t addressed on the care plan, no matter how often the family member tells staff about the concern, the structure to meet the concern is not in place. Find out the chain of command within the facility to report concerns effectively. Reminding a nursing assistant or perhaps even an LPN that the care plan is not being followed is not the same as notifying the facility. Family advocates to page 24

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Family advocates from page 23

Family advocates can request medical records, and should do so periodically for accuracy, completeness, and to determine any information not previously shared with the family. If the records are in error, advocates should ask for an amendment to the record, which is allowed under HIPAA (Health Insurance Portability and Accountability Act) laws and regulations. When a family member’s concerns are not addressed, there are several options that may be appropriate for them to pursue: • Get a second opinion from another physician related to concerns of diagnosis or condition.

Family advocates can request medical records.

• Make an appointment with the director of nursing or the nursing home administrator to share the concerns. • Consider filing a complaint with the Office of Health Facility Complaints at the Minnesota Department of Health. • Contact the Ombudsman for Long-Term Care Office to act as an advocate for the resident. In drastic situations of suspected maltreatment by staff and/ or patterns of detrimental care, the family can consider finding a different facility. This is considered a last resort option and must be weighed against the detrimental effects of moving the resident.

Summing up Family advocates can ensure the comfort and care of loved ones in assisted living arrangements, in nursing homes and group homes, and in other long-term care settings. Take the time to review all admission documents, attend care meetings, monitor health care decisions and daily care, and document concerns should they arise. It is your right to advocate for change, but do so in an effective, professional manner, and make sure that your concerns reach those in charge. Doing so may resolve the situation without further conflict. Effective relationships between family advocates and long-term care providers stem from mutual respect, knowledge, and an understanding of the respective roles of each. With the number of residents in long-term care rising, families and providers must continue to partner in order to maintain the highest possible quality of life for the elder. Suzanne M. Scheller, JD, practices elder law and advocacy at Scheller Legal Solutions LLC, with a focus on nursing home litigation, financial exploitation, and public policy. She is also a founding board member of the Minnesota Elder Justice Center, former chair of the Elder Law Section of the Minnesota State Bar Association, and an adjunct faculty member at Hamline University School of Law and William Mitchell College of Law.

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Multiple sclerosis from page 21

The ultimate breakthrough will be a medication that not only prevents new lesion formation or slows progression, but will actually restore or repair prior damage. Stem cell research to repair myelin and nerve damage is ongoing. There is also research in early safety clinical trials for other compounds to help promote nerve repair. Even though there is little to slow disease progression, there are many medications that target specific symptoms of MS that can help improve a patient’s function and quality of life.

diagnosis patients earlier and start disease modifying treatments to prevent disability and new clinical symptoms. There are options available for those patients whose disease does not respond to initial treatments. For patients with progressive MS, we are making advancements both in the potential to slow disease progression and, potentially, to reverse symptoms. The future is indeed bright. Jessica Stulc, MD, MPH, practices at the Minneapolis Clinic of Neurology, and is associate director of the clinic’s Multiple Sclerosis Treatment and Research Center. She is board-certified by the American Board of Psychiatry and Neurology.

The exact cause of MS remains unknown.

Living with MS While the advancement in new treatments is a triumph and is changing the future for many MS patients, basic wellness routines cannot be overstated. I encourage patients to promote wellness and health with a regular, well-balanced diet and routine exercise. Exercise not only helps preserve muscle strength, but can improve mood and help to manage stress. I also encourage patients to be mentally active. Good sleep hygiene can improve energy and help with cognition. Wellness for patients with MS must be a lifestyle, not just a medication regimen. The prognosis for those diagnosed and living with MS has drastically changed for the better in the past few decades. We can now

Additional Reading: Research updates from the Multiple Sclerosis Association of America: mymsaa.org/publications/msresearch-update-2015/ Information on medication from the National Multiple Sclerosis Society: www.nationalmssociety.org/Treating-MS/Medications Information on wellness from the National Multiple Sclerosis Society: www.nationalmssociety.org/Living-Well-With-MS/Health-Wellness

January 2016 Minnesota Health care news

25


Optometry

Corneal abrasions A painful but treatable condition By Michael V. Dieter, OD

M

ost of us can recall tripping and scraping the skin off of our hands or knees. Painful as these abrasions can be, a similar trauma to the front window of the eye—the cornea—can produce even more severe pain. The culprit behind the intense pain of corneal abrasions is the high concentration of nociceptors, or pain receptors, which is greater than anywhere else in the body. Densely packed on the clear tissue of the eye, they efficiently send a message to our brain that something is definitely wrong and attention is needed.

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Minnesota Health care news January 2016

The mote (and more) in your eye Your eyes boast many natural lines of defense. Nestled between the brow and cheekbone, the eye is partially protected by its very location, and is often able to deflect blunt injury to itself. The eyelid and lashes provide further protection from trauma and foreign material reaching the eye itself. And the cornea provides a clear, protective barrier covering the iris, or colored part of the eye, and the pupil, which allows light to pass in to the retina. Yet, numerous accidents can cause injury to this vital tissue, and caution and protection can pay dividends.


At some point, all of us have experienced how the smallest piece of dirt, wood, metal, seed, chaff, insulation, or displaced eyelash can erupt into an immediate awareness that something is scratching the cornea. These simple irritants exemplify how sensitive the cornea is to pain, even when it involves minor injuries. When a full-scale corneal abrasion results, however, the pain is even more intense. It could come without warning, from multiple sources. A parent snuggling with a baby can encounter the quick movement of the child’s hand, causing a scratch or abrasion of the cornea from a fingernail. A tree branch snapping back to its original position can swipe the eye and create this problem. Athletes can suffer similar injuries from the poke of a finger. Corneal abrasions can also result from wearing contact lenses too long, a small error during eye surgery, the continual rubbing from blinking when a foreign material remains trapped beneath the upper eyelid, or an eyelash turned inward with continual blinking. Injurious chemicals splashed in the eye can also create similar effects. If the ocular surface is severely dry, the eyelid can stick to the cornea and peel a layer of cells from the cornea when the lid is opened after sleep. Regardless of the source, the pain is similar in each of these examples.

watering, sensitivity to light, hands over the eye, and pain with each blink of the lid are other symptoms characteristic of a corneal abrasion. Upon examination by a clinician with the use of a biomicroscope (a specialized instrument that allows various angles of viewing and lighting to study the eye), the location, size, and depth of the abrasion can be determined. One key concern, of course, is ruling out a penetrating injury that could affect the inside of the eye or cause permanent harm to vision. In the past, corneal abrasions were often treated by placing an antibiotic in the eye, followed by a “pressure patch” of cotton gauze taped tightly to the lid. In recent years, this procedure has been commonly replaced by an antibiotic drop or ointment, followed by a bandage contact lens placed on the cornea and worn for a day before rechecking the progress. This usually results in an immediate and significant improvement in comfort, as the upper lid is prevented from hitting the edges of the abrasion with every blink. Appropriate lubricating drops, preferably preservative free, may provide additional relief. Opinions may vary over which drop works best under these conditions, but I prefer Oasis from Oasis Medical.

Most corneal abrasions heal well without a trace.

Symptoms and treatment A key symptom of corneal abrasion is the sudden onset of intense eye pain. A deeply injected eye (showing red areas), profuse

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With larger and deeper abrasions, healing takes more time, and additional measures may be necessary. When the injury is caused Corneal abrasions to page 31

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Pediatrics

Head lice A common annoyance By Rebecca Doege, MD

N

ow that school is in session, parents are probably expecting their children to come home with at least one infection “shared” by classmates. In addition to the usual sniffles and coughs, head lice are a very common infection (or infestation) in school-age children. It is difficult to know exactly how many children are infected each year. Some estimate yearly costs related to head lice at $1 billion, including treatments, missed work for parents, and doctor visits.

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Minnesota Health care news January 2016

Facts and misconceptions What are these little nuisances? Head lice are small insects (about the size of a sesame seed) that live on the human scalp. They feed on small amounts of blood. Females lay five to 10 eggs, called nits, each day, which are firmly attached to the hair shaft. New lice hatch in seven to 12 days, and after two weeks are ready to mate and lay their own eggs. Lice cannot jump or fly between people. They can only move by crawling, so spreading lice in a classroom or through a family requires close head-to-head contact. They can also be spread by sharing objects such as hats and hairbrushes. Lice can survive for up to two days on an object separate from a human host. Head lice that infect humans do not live on animals and are not spread by household pets. The most accurate way to identify a lice infestation is to see live bugs crawling on the scalp. Seeing nits attached to the hair is also a telling sign. Sometimes, the affected person will complain of scalp itching, but not always. The insects can crawl very quickly, and they avoid light, so they may be difficult to find. Nits are white or tan and are most commonly found near the hairline on the back of the neck and near the ears. It is important to distinguish nits from dandruff, dried hair products, or other debris, all of which are easy to remove and not attached to the hair. New nits are laid very close to the scalp. Nits that are found further down on the hair—more than 1 centimeter away from the scalp—are likely already hatched or dead. Nit picking What should you do if your child or another family member has lice? The American Academy of Pediatrics (AAP) recommends that the entire family be checked for lice if one member is infested. All family members with nits found within 1 centimeter of the scalp, or live bugs found on the scalp, should be treated. Also, any family members who share a bed with the infested person should be treated, even if no nits are found. A simple but time-consuming treatment is manual removal of live bugs and nits. This can be accomplished using just your fingers, or with a special very fine-toothed nit comb. Remember that nits


more than 1 centimeter from the scalp do not need to be removed, as they are likely already hatched or dead. Although it can be effective, combing is time consuming and requires frequent combing for at least two weeks until all existing lice have been removed and no new nits are appearing. Businesses have evolved to do this combing for busy parents, for a cost of course. This method is usually used along with a product to kill lice and nits. Medications Most commonly, lice are treated with overthe-counter (OTC) products such as Nix or Rid. The active ingredients in these products are permethrin or pyrethrum, which kill lice and nits. These products are applied all over freshly shampooed hair, left on for several minutes, and then rinsed out. It is recommended that a second treatment be applied nine days later to kill any bugs that may have survived or hatched after the initial treatment. It is important that the shampoo used before treatment is non-conditioning shampoo, because conditioning products make it more difficult for the medication to stick to the hair.

been found in many states, including Minnesota. It is difficult to know how common resistant lice are, but in one study all the sampled lice from Minnesota were resistant. Most doctors still recommend starting with the over-the-counter lice treatments as they are the most budget friendly and readily available. If you have used an OTC product as directed and are still finding new nits or live bugs, it may be time to contact your doctor. First, ensure that OTC products have been used correctly, including the second application nine days later. Your doctor will likely check to confirm that there is, in fact, a lice infestation and not another problem mimicking lice infestation. If needed, there are several prescription treatments available. The active ingredients in these products include malathion and ivermectin. These products are effective even for resistant lice, and are safe when used as directed.

Head lice that infect humans do not live on animals.

Unfortunately, some lice have become resistant to OTC products. This is a growing problem across the U.S. Resistant lice have

As with any medication, it is important to know the possible side effects of any treatment used for lice. All lice products, OTC or prescription, have the potential for skin irritation. If a prescription is needed, your doctor will inform you of any other side effects or precautions you should be aware of. Head lice to page 30

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Head lice from page 29

Some home remedies have been reported to be effective at getting rid of lice. One method consists of covering the scalp with a thick occlusive product such as mayonnaise or petroleum jelly, then covering the head with a shower cap for a number of hours. These methods presumably work by suffocating the bugs. There are also reports of various natural oils working as a repellent to lice. Although there are many accounts of these methods being effective, the Minnesota Department of Health points out that there is little scientific evidence to support their effectiveness.

situations. Contrary to popular belief, head lice infestation is not a sign of poor hygiene. Head lice do not carry disease. Lice are seen in people from all socioeconomic backgrounds. By the time a child is identified as having a head lice infestation, it is likely that he or she has already been infested for several weeks. Therefore, it is not necessary to keep infested children out of school. Both the AAP and the Minnesota Department of Health recommend against “no nit” policies in schools, as they tend to be excessively restrictive. After any lice treatment, nits will still be visible unless they are manually removed. Remember that the presence of nits, especially on hair far from the scalp, does not necessarily mean there is an active infestation.

$ Lice are seen in people from all socioeconomic backgrounds.

While family members are being treated, it is important to get rid of lice on objects and in the home as well. The AAP recommends washing bedding and clothing in hot water if those items have been in contact with an infested person. Items that cannot be washed can be placed in sealed plastic bags for two weeks. Lice will die within two days after being removed from a host, but it may take two weeks for unhatched nits on the object to hatch and subsequently die without a food source. Prolonged freezing cold will kill lice and nits, but normal outdoor activities during the winter won’t eliminate an infestation; lice will continue to thrive near the scalp’s natural body heat.

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Summing up As the school year continues, it is likely that many parents will receive the dreaded call or note from their children’s schools. Though lice are an aggravating problem, they can be effectively treated and are more of an annoyance than a threat to health or well-being.

Minnesota Health care news January 2016

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Corneal abrasions from page 27

by an organic source, such as an evergreen branch, a small residue of chemical is left at the wound site, and may require more time to heal, as compared to injury from an inorganic object such as plastic. If an abrasion is experienced, it is rarely forgotten, and we wish for it to never occur again. Yet, most corneal abrasions heal well without a trace when superficial in nature. If deeper layers of the cornea are affected, compromises to vision due to scarring can exist after healing has taken place. This is particularly true when the injury occurs on the center of the cornea and in the line of sight. Thankfully, however, most corneal injuries are superficial.

Dealing with recurrent corneal erosions can be not only aggravating to the patient, but a challenge to the clinician. In recent years, however, therapy has improved in a number of ways to bring success for these individuals. One approach is to use natural healing agents such as autologous serum eye drops, amniotic fluid eye drops, or amniotic membrane tissue placements over the cornea for one to two weeks. All of these methods have been shown to promote a faster and more secure healing. Another approach is to use a needle to make small scars around the circumference of the abrasion. This is performed under local anesthesia, and allows for numerous anchor points to help secure the new tissue. A more drastic approach is to anesthetize the cornea, remove the entire front layer of cells from the cornea, wear a soft bandage contact lens, and allow the whole new surface to grow back. Each of these methods has been found successful for treating recurrent corneal erosions.

Corneal abrasions can also result from wearing contact lenses too long.

Continued corneal trauma Some people experience recurrent corneal erosions, with injuries returning due to insufficient healing. To understand why, consider trying to glue two wet pieces of paper together. In this example, the pieces of paper would not stick to each other unless they were first dried. In the case of the cornea, when an abrasion occurs, and the front layer of cells is removed, the barrier is broken, allowing water to seep into the tissue. This edema, or excess water, can make it difficult for the new layer of returning cells to secure and anchor properly to the basement membrane. If not secured, the new layers can easily be peeled off again at a later date, bringing about the same symptoms that were present initially.

Discover

Conclusion Corneal abrasions can cause intense pain, but often heal by themselves with few long-term effects. Try to avoid irritants such as dust and dirt, and protect yourself from injuries during sports or physical activity. See your eye doctor immediately for more serious injuries, which could lead to vision loss or to recurring corneal erosion. With proper care, these long-term risks can be minimized. Michael V. Dieter, OD, is founder of Dry Eye Clinic, LLC in Maple Grove, Minn.

Have You heard about the BioMat?

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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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• Stress and anxiety relief

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• Relief from persistent infection

• Detoxification

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We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason. If you order through us, you will also receive a 30 year repair guarantee and lifetime trade-in policy.

866.689.7336 For more details please visit: www.crystalbiomat.com January 2016 Minnesota Health care news

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The Green House Project from page 17

Each Green House home is designed with private rooms and private baths for 10 elders. The choice of housing only 10 elders is by design. The rooms surround a central living room with a fireplace, a big family-style dining table, a homelike open kitchen, and additional lounge spaces. In accordance with The Green House Project guidelines, the staff room is “a tight fit for one person and impossible for two people,” so staff spend only necessary time there and more time with the residents. Each home is served by two primary caregivers. They are CNAs who have received 130 hours of additional training to earn the title of “Shahbaz” (after a mythical royal Persian falcon that protected, sustained, and nurtured its people).

the activities they want to participate in. Residents can sleep late and have breakfast whenever they want. They have private rooms so can spend time by themselves. Staff can read or talk to residents, play games, or bake cookies. Residents can help cook meals, do personal chores like folding clothes, go to concerts or lectures, and watch movies. There are six outdoor gardens and residents are encouraged to garden if they want. Branching out The Green House Project is a national movement that has been transforming the quality of life for our elders for over a decade. To date, it has reached 32 states—including Green House Homes operated by the Veterans Administration. For the whole story, visit www. thegreenhouseproject.org.

Residents are treated with respect and their wishes and requests are met.

The ratio is one Shahbaz per five elders. The result is more personal attention than in conventional nursing homes. The elders and their caregivers all dine together at the same table like the family they are.

Residents are treated with respect and their wishes and requests are met. They have input into their daily schedule and can choose

Deb Veit, the former director of community relations at Episcopal Homes of Minnesota, has over 25 years of nursing experience with an emphasis on geriatrics and nursing home care. She is currently the campus marketing director at Woodbury Senior Living.

December 2015 Survey

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

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

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. I am aware of how health care legislation is enacted on a state level. 35%

2. I am aware of the role I can play in working with my state legislators to help shape health care policies. 40% 40%

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3. I believe payers (insurance companies or government) should not have the authority to limit the range of care my physician can offer me. 50% 50%

25

30 30

40 40

20 30 30

20 20

15

20 20

10

10 10 10 10

5 0

Strongly agree

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No opinion

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4. I think that health care costs should be regulated by state law. 35% 35%

00

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

5. I feel that health care policy will be an important part of the upcoming presidential election. 50% 50%

30 30

40 40

25 25 20 20

30 30

15 15

20 20

10 10 10 10

55 00

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Strongly agree

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No opinion

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Minnesota Health care news January 2016

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

0 0

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 January 2016 Minnesota Health care news

33


Headaches from page 15

recommended routinely due to their habit-forming nature and other risks. Cluster headaches can often be treated with triptan medications and 100 percent oxygen inhalation through a face mask for about 20 minutes. If that fails to relieve the headache, then other medications tried are octreotide injection, lidocaine applied inside the nose, or ergotamine.

cluster headaches, and is generally well tolerated. It may take three to four weeks to achieve the complete benefit of preventive medications. Prednisone, a steroid medication, is also effective in preventing cluster headaches, but cannot be taken long-term due to side effects with prolonged use. Many mild to moderate headache attacks can be treated with nonprescription medications such aspirin, acetaminophen, and NSAIDs (e.g., ibuprofen or naproxen). Other medications combine aspirin, acetaminophen, and caffeine. Over-the-counter pain relievers should only be used once or twice each week as needed. More frequent use could cause medication-overuse headaches. A physician should be consulted to discuss treatment options for more frequent headaches.

Injection procedures. Patients who do not obtain relief from medications and other treatments may respond to an injection procedure called occipital nerve block. Numbing medicine, with or without steroidal medication, is injected along the occipital nerve at the back of the head. For patients who suffer from headaches due to problems with the neck, a thorough evaluation with an interventional pain or spine specialist is recommended, and certain injection procedures targeting the facet joints or medial branch nerves in the neck can provide relief. A procedure called radiofrequency denervation can provide long-term relief for six months to more than a year at a time.

Seek evaluation and treatment if headaches affect your quality of life.

Aspirin and NSAIDs should be used with caution or avoided completely in people with stomach ulcers, kidney disease, or bleeding disorders. One prescription NSAID (indomethacin) can be especially effective for migraine headaches. Anti-nausea medications may help with the nausea associated with certain headaches. Triptan medications and ergots are specifically used to abort migraine attacks. In certain special situations, medications containing butalbital or opioids may be prescribed by a physician, but these are not

Rohaan F. Mehta, MD, is the medical director at Advanced Pain Management clinic in Mankato, Minn. He is board-certified in both pain management and physical medicine and rehabilitation by the American Board of Physical Medicine and Rehabilitation.

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CB, Lake Benten, Minnesota The Diabetes Sentry™ has been a Godsend for my CB, Lake Many Benten, Minnesota Diabetes has been a Godsend forifmy husband. nights he wouldThe wake up and Sentry™ feel my arms or forehead to see I was husband. Many nightsinto he awould wakeI have up and arms forehead to see since if I was perspiring and going reaction. notfeel hadmy any veryorlow blood sugars I perspiring and going into a reaction. I have not had any very low blood sugars since got it because it alarms soon enough where I can get something to eat right away. I got it because it alarms soon enough where I can get something to eat right away.

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Minnesota Health care news January 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