07 mn healthcare news july aug 2015 by Minnesota Physician Publishing

July/August 2015 â&#x20AC;˘ Volume 13 Number 7

Spleen health Sara Torgerson, DO

Carpal tunnel syndrome Kari Paulson, OTR/L

Hernia Repair Mark Reiner, MD, FACS

L ife. We help people get back to it! 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.

To make a referral or for more information, call us at (866) GSS-CARE or visit www.good-sam.com/minnesota.

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Minnesota Health care news July/August 2015

July/August 2015 • Vol. 13 Number 7

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News

PEOPLE

Technology

Telehealth By Richard F. Sethre, PsyD, LP

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cALENDAR

10 Questions Debra DeBruin, PhD Center for Bioethics, University of Minnesota

ternal In Medicine

Spleen health By Sara Torgerson, DO

physical fitness

Surgery

Hernia repair By Mark Reiner, MD, FACS

Physical Therapy

Carpal tunnel syndrome By Kari Paulson, OTR/L and Wendy Camp, OT, CHT

Camping By Commissioner Tom Landwehr

Dermatology

oisonous plant P reactions By Margaret Collins, MD

MINNESOTA HEALTH CARE ROUNDTABLE

2015 Health care Architecture Honor Roll ix outstanding building projects S By MPP Staff

FORTy-FOURTH SESSION

Behavioral Health Integration New pathways to care

Thursday, November 12, 2015 • 1:00-4:00 PM Downtown Minneapolis Hilton and Towers Background and Focus: Increasing evidence supports the link between access to mental health care and reducing health care costs. Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider. Many initiatives nationwide are addressing this issue. It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015. Some states, including Minnesota, are also creating Behavioral Health Home programs. Objectives: We will review numerous initiatives that support the development of new pathways to behavioral health care. We will introduce new ideas and discuss how to incorporate them into our health-care delivery system. We will examine the value they can bring and the challenges they will face. Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring. Panelists include: • Sarah Anderson, MSW, LICSW, CEO Psych Recovery, Inc. • Lee Beecher, MD, President, Minnesota Physician-Patient Association • Judge Kerry W. Meyer, Fourth Judicial District Court, Hennepin County Criminal Mental Health Court • Jane Pederson, MD, Medical Affairs Director, Stratis Health • Jeff Schiff, MD, MBA, Medical Director, MN Dept. of Human Services • L. Read Sulik, MD, Chief Integration Officer, PrairieCare Sponsors include: • MN Dept. of Human Services • PrairieCare • Psych Recovery, Inc. • Stratis Health

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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.

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News

Cases of Childhood Nicotine Poisoning Rise Sharply Childhood poisonings in Minnesota due to e-cigarettes continue to rise, according to a new report from the Minnesota Poison Control System. There was a 35 percent increase in e-cigarette and e-juice poisonings in children from birth to five years old between 2013 and 2014. This is still a relatively new health issue. In 2011, there was only one case of child poisoning attributed to e-cigarettes and e-juice, and in 2012 that rose slightly to three cases. However, in 2013 that number jumped significantly, to 46 poisonings, and continued its upward trend in 2014, to 62 cases. Many of these resulted from children ingesting e-cigarette liquids that were left unattended, through being swallowed, inhaled, or absorbed through the skin or eyes. About half of these cases were treated at emergency departments.

The increase in poisonings, along with the fact that e-juice can contain fatal levels of nicotine for children, prompted the Minnesota Department of Health (MDH) to issue a health advisory for parents to educate them about the dangers involved with nicotine poisonings. A fatal dose of nicotine for an adult is between 50 to 60 milligrams, and a fatal dose for children is expected to be less, according to MDH. The e-juice containers used for e-cigarettes have varying amounts of nicotine, from 0 milligrams up to 34 milligrams or higher. Nicotine levels in e-juice are currently unregulated, meaning people never really know how much nicotine they contain. Minnesota took a step towards prevention in January, when legislation went into effect that requires e-juice to be sold in child-resistant packaging. However, as the popularity of e-cigarettes continues to rise, MDH officials say parents need to be aware of the dangers and take proper precautions at home.

“This past year Minnesota took a big step to keep kids from accidentally ingesting these potentially fatal e-liquids,” said Ed Ehlinger, MD, Minnesota commissioner of health. “But parents should still use caution and store the products out of the reach of children.”

MDH to Track Harmful Chemicals in Pregnant Women The Minnesota Department of Health (MDH), HealthPartners, and SoLaHmo Partnership for Health and Wellness/West Side Community Health Services are collaborating on a new research project aimed at protecting people from mercury, lead, and cadmium. These chemicals can be taken in through food, products, and the environment. The project, called Minnesota Family Environmental Exposure Tracking (MN FEET), is designed to determine if the chemicals are present in a woman’s body as well as in their newborn babies.

The project will include up to 600 women over the course of two years. It will focus on Hmong, Latina, Somali, and white women who receive prenatal care at HealthPartners and West Side Clinics. Once they consent to be a part of the project, women will answer a questionnaire over the phone, and after the baby is born, the woman’s provider will collect urine and cord blood samples from the mother to test for the presence of the chemicals. MDH will then contact the woman if the test results are high and work with her family to identify the source of the chemicals and help reduce further exposure. The project also aims to determine any differences in exposure rates between the communities and to educate pregnant women on how to best avoid coming into contact with the chemicals. “MN FEET is important because it will identify the harmful chemicals that women and children in some communities are getting exposed to,” said Amira Adawe, planner and health educator at St.

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Minnesota Health care news July • August 2015

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Paul–Ramsey County Public Health. “The study will help reduce disparities in environmental exposures.”

Insurers Propose Significant Rate Hikes for Individual Health Plans Several Minnesota insurers have proposed significant rate increases for individual health insurance plans, according to the Minnesota Department of Commerce. Federal law requires any proposed premium increases above 10 percent to be disclosed months in advance for review and approval. Twenty-seven plans have proposed increases above 10 percent, with an average proposed increase of 43 percent. The highest proposed increase was 74 percent, for a plan offered by Time Insurance Co. Blue Cross Blue Shield of Minnesota has proposed increases of more than 50 percent for nine of its individual health plan products. About 171,000 of the 300,000 Minnesotans enrolled in individual plans would be affected by these increases alone. Rates must be approved by the Minnesota Department of Commerce before they are official, and the department can deny or modify rates it finds excessive. It is accepting public comments on the proposed increases through July 31. Official rates will be announced Oct. 1 and they will take effect Jan. 1, 2016. Gov. Mark Dayton called the hefty proposed increases “outrageous” and called for a “rigorous review” of the proposals, which Minnesota Commerce Commissioner Mike Rothman has committed to doing.

Teen Pregnancy Prevention Program Receives Grant Hennepin County has received a five-year, $7.5 million federal grant to expand its program to reduce teen pregnancies. The program, called Better Together Hennepin, was launched in 2007. By the end of 2013, teen

pregnancies had fallen 50 percent, according to Hennepin County. Better Together Hennepin partners with schools and clinics to increase young people’s access to comprehensive sex education and reproductive health care. It tracks where pregnant teens give birth and concentrates its efforts in the areas that show the highest concentrations of teen pregnancies. “Everyone benefits when young people wait until they are adults to become parents,” said Katherine Meerse, program manager of Better Together Hennepin. “Young people who postpone parenthood are more likely to finish high school and become contributing members of the workforce. Children born to adults are more likely to have a healthy birth weight and be prepared for school. Taxpayers profit from reduced welfare rolls and less spending on publically funded medical care.” Better Together Hennepin will use the federal grant funds to implement a project called It’s OUR Future, which aspires to cut teen birth rates in the county by an additional 30 percent by 2020.

Program Offers Early Psychosis Treatment for State’s Youth Minnesota lawmakers have approved funds for a program to offer early detection and treatment of psychosis in young people. The state has dedicated $1 million through 2019 for the program, which aims to help the estimated 1,500 youth that have their first episode of psychosis each year in Minnesota. They will now be offered intense early psychiatric treatment after their first episode. Early detection and treatment can significantly reduce the chances of them having another episode or being hospitalized. “If you are able to provide services for young people when they first show psychotic symptoms, you can push off full onset,” Department of Human Services Commissioner Lucinda Jesson said when the measure was being introduced earlier this year. “We want to develop pilot programs News to page 6

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News from page 5

around the state that will identify kids and get them help when they display that first sign.” DHS officials met with mental health leaders, health care providers, and activists in the community to determine priorities for mental health care in Minnesota. They plan to model their early intervention program after one established at the University of Minnesota in 2009 that has helped more than 500 young people.

Park Nicollet to Open Health Center at Richfield High School Park Nicollet will partner with Richfield High School to create a free health center on campus for students who live in or attend schools in Richfield. The health center will offer care to children from birth through high school graduation for minor conditions such as flus, colds, and

ear infections. It will also offer school and athletic physicals, referrals for lab and X-ray services, dental care, mental health care, and prescriptions. There will be no eligibility requirements. “Good health and school attendance are directly related to academic success and this health resource center will ensure that all students can get health services they need without leaving school,” said Steve Unowsky, superintendent of Richfield Public Schools. The health center will occupy three empty classrooms within the school with a separate entrance. It will be open five days a week and will be staffed by Park Nicollet physicians, nurses, social workers, and counselors. “We know from our Community Health Needs Assessment that there is a need for youth to have increased access to care—care that is more affordable—and for mental health services; school health centers fill this gap,” said Christa Getchell, president of the Park Nicollet Foundation.

The project is awaiting approval from the school board. If it is approved, the clinic is expected to open in early 2016. It would be Park Nicollet’s fourth school-based health center in the metro area.

Abortions Increase After Year of Decline The number of abortions performed in the state rose by 2.2 percent last year, according to an annual report from the Minnesota Department of Health. There were 9,903 abortions in 2013 and 10,123 in 2014. This was the first time Minnesota’s abortion rates increased since 2006, when 14,000 abortions were performed. The highest increase in abortions was among American Indians, at 5 percent. Rates also rose slightly among Asian Americans and decreased slightly among whites and African Americans. However, the majority of abortions performed were among white women, at 5,336.

About 90 percent of all abortions took place in the first trimester of pregnancy; the rest took place in the second trimester. Obstetrics and gynecologists performed about 69 percent of the procedures; the rest were performed by general or family practice practitioners with the exception of three cases that were performed by emergency medical workers. According to the report, 85 percent of women who had abortions in 2014 were unmarried; 91 percent were from Minnesota; 76 percent were between 20 and 35 years old; 60 percent had never had an abortion before; 58 percent had previously given birth to at least one child; and 66 percent didn’t use contraceptives at the time of conception. The most common reason women gave for having an abortion was that they did not want children at this time, while 74 women said the reason was that their pregnancy was a result of rape and 13 said it was a result of incest.

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Minnesota Health care news July • August 2015

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People Thomas E. Jones, MD, board-certified family physician, has joined the Apple Valley Medical Clinic. Previously, Jones worked for the Allina Health Clinic in Burnsville and the Farmington Family Clinic. Jones earned his medical degree from the Duke University School of Medicine in North Carolina and completed his residency at the University of Tennessee, St. Francis Hospital.

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Amer Kalaaji, MD, a Mayo Clinic specialist in dermatology, has started seeing patients at FamilyHealth Medical Clinic in Lakeville. Kalaaji is an associate professor at Mayo Medical School in Rochester and will be at the Lakeville clinic three days a week, providing services through Mayo Clinic Specialty Services. He earned his Amer Kalaaji, MD medical degree from the University of Toronto School of Medicine, completed an internship at Toronto General Hospital, and completed a dermatology residency at Henry Ford Hospital in Detroit, Michigan, where he also served as chief resident. He also did graduate work at the University of Toronto’s Department of Pathology. Mohan Karki, MD, and Ranjita Adhikari, MD, have joined Mille Lacs Health System in Onamia as family practice physicians. Karki has a background in rural medicine, in the U.S. and in his native country of Nepal. He earned his medical degree from Manipal College of Medical Science in Pok hara, Nepal and completed an internship at Tansen Mission Hospital in Kathmandu. He taught medical students pharmacology in China, and came to the United States to complete a medical residency at the University of Pittsburgh Medical Center in McKeesport, Pennsylvania. Adhikari earned her medical degree at the Sir Salimullah Medical College in Dhaka, Bangladesh and completed her family practice residency at Altru Health System in Grand Forks, North Dakota. Prior to that, she began her family practice residency at the University of Pittsburgh Medical Center in McKeesport, Pennsylvania.

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Uzma Samadani, MD, PhD, has joined the department of neurosurgery at Hennepin County Medical Center. She will serve as the Rockswold Kaplan Chair for Traumatic Brain Injury Research and be appointed as an associate professor of neurosurgery at the University of Minnesota. Samadani earned her PhD and medical degree at Uzma Samadani, the University of Illinois in Chicago, completed MD, PhD a residency at the Hospital of the University of Pennsylvania, and completed a Van Wagenen Fellowship in Goettingen, Germany. She currently serves as chief neurosurgeon at Manhattan Veterans Hospital and assistant professor of neurosurgery at New York University as well as assistant professor in the departments of psychiatry, physiology, and neurosciences at New York University School of Medicine. She co-directs the Steven and Alexandra Cohen Center for Veteran Traumatic Brain Injury and Post Traumatic Stress at NYU Langone Medical Center. July • August 2015 Minnesota Health care news

10 Questions

The importance of ethics Debra DeBruin, PhD Dr. DeBruin is director of the Center for Bioethics at the University of Minnesota. She teaches and conducts research on the ethics of research and public health policy.

What is bioethics? Bioethics addresses ethical issues in biomedical research and the health and life sciences. It attends to questions that arise in clinical settings. It also, for example, encompasses public health ethics issues such as health disparities, environmental ethics issues such as those concerning approaches to mitigating climate change, and ethical issues in the life sciences such as those related to genetically modified organisms. It is an interdisciplinary field; this diversity of voices promotes rich engagement with issues and really enhances our understanding of them. Why do we need bioethicists? Bioethicists address issues that affect everyone. We research and analyze ethics questions and work with students, professionals, policy makers, and the public to promote understanding of these issues. We offer consultation to clinical and research teams when they encounter difficult ethical issues in their work. We advise policy makers, as with recent questions about how to manage the Ebola response in Minnesota. We also engage the public—for example, we might lead a discussion with a community group about the importance of advance directives for care at end of life, or about debates over the Affordable Care Act. What are the ethical issues to consider when breaking bad news to a patient? It may seem odd to think about good communication as an ethical issue, but it is essential to respecting patients and promoting their well-being. Providers should be compassionate but clear, and explain the significance of clinical results for the patient’s prognosis. Uncertainties should be acknowledged, and patients should have an opportunity to reflect and ask questions. When teams of providers are involved in care, there should be a process for coordinating information rather than providing it to the patient in a piecemeal fashion. Patients need to be supported as they develop an understanding of what this news means for their lives, and should be encouraged to discuss their wishes for how their care

Minnesota Health care news July • August 2015

should be managed. Of course, there are complexities to consider for pediatric patients or adults who have compromised capacities to understand such information and make decisions. What are the latest thoughts in the ethics community around end of life issues? There is increasing concern about cases involving disagreement between clinicians and patients or their families about whether continued treatment of a patient’s condition will benefit the patient. These disagreements can be wrenching for all involved and very challenging to resolve. It is important that patients be supported with appropriate comfort care and compassionate interactions no matter what decision is made about continued treatment. There has also been a great deal of attention paid to physician aid in dying. Oregon, Washington, Montana, Vermont, and New Mexico have legalized physician aid in dying, and bills to do so have been introduced in another 26 states plus the District of Columbia during the 2015 legislative session. Minnesota is one of these states, bringing the debate very close to home. Dr. X believes his ethics are right. Dr. Y believes her ethics are right, but they differ completely on the same issue. Who is right? There is definitely room for disagreement among thoughtful, morally sensitive individuals. This does not mean that anything goes, though. We may find common ground if we move discussions about ethical issues beyond a clash of moral intuitions to an exploration of our reasons for our views. Such discussion can promote respectful understanding. There are some ethical values that are fundamental to the profession of medicine even though tensions may arise with clinicians’ personal moral views. For example, clinicians who disapprove of particular lifestyle choices may not abandon patients who make those types of choices.

What are some of the ethical issues faced by medical researchers? Increasingly, community clinicians collaborate on research projects, so these issues don’t concern only academic physicians. Overall, researchers must promote the rights and well-being of people participating in research. Participants’ informed consent is required before they can be enrolled in research, and they should be allowed to withdraw from the study at any time without pressure or penalty (or their continued involvement is not voluntary). Privacy and confidentiality should be protected. Risks should be minimized and reasonable in relation to potential benefits from the study. If we are not likely to learn something important in a study, we should not expose human volunteers to risk in that research. Researchers need to be fair about who they recruit into studies. They should not target people simply because they may be easy to recruit—for example, people who would find it hard to refuse the opportunity to use a study to access care. Researchers should also not arbitrarily exclude certain populations from research—for example, studies of conditions that affect both men and women should include both groups. Conflicts of interest also pose significant concerns.

to ethically ration scarce resources during an influenza pandemic. We developed an ethics framework to guide rationing, as well as a wide-reaching ethical analysis of challenges that the state would likely encounter in applying that framework, including health disparities and access barriers, the use of age in rationing decisions, concerns about liability, and management of palliative care in pandemic, among others. To develop the ethics framework and implementation guidance, we consulted extensively with stakeholders specializing in infectious diseases, public health, law, public safety, community advocacy, and so on. Then, in addition to a public comment period, we led a series of community engagement meetings across the state to make sure that diverse citizens could give input on the draft guidance. The project’s main reports can be found on the MDH website.

There are some ethical values that are fundamental to the profession of medicine.

How do ethics factor into issues around social determinants of health? A person’s health status can be significantly affected by social factors such as access to good educational and employment opportunities, availability and affordability of healthy foods and safe housing, discrimination and stigma, among others. Some groups tend to suffer from poorer health related to social and economic inequalities, and not simply due to barriers in access to care. For example, we know that members of certain racial and ethnic groups tend to suffer disproportionately in infectious disease outbreaks such as influenza pandemics. How should pandemic plans respond to this disparity? Some groups have more difficulty complying with complex treatment regimens given their social realities. How should they be appropriately supported? Health disparities pose critical social justice issues. Please tell us about some of the work you did with President Clinton. I worked as a consultant to President Clinton’s National Bioethics Advisory Commission. I worked on a report that evaluated how well our oversight system protects the rights and welfare of human participants in research and made recommendations for reform. I researched and drafted analyses of a number of ethical issues in research, including how to manage risk/benefit assessments and how to implement appropriate safeguards for vulnerable populations in research. I have continued to work on a number of these issues in my faculty position at the University of Minnesota, especially issues concerning vulnerable populations. What is the Minnesota Pandemic Ethics Project? Beginning in 2007, the Minnesota Department of Health (MDH) sought ethics guidance for influenza pandemic planning efforts in the state. The University’s Center for Bioethics worked on this project in partnership with the Minnesota Center for Health Care Ethics; I led the team from the university. MDH was especially interested in how

In the physician/patient relationship what are some of the ethical issues incumbent on both parties? The goal is to have clinicians and patients work together to promote shared decision-making. This requires that they talk honestly and openly about problems and treatment possibilities; again, good communication is critical here. Shared decision-making is best supported when all parties demonstrate mutual respect and there is a foundation of trust from which to work.

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Internal Medicine

Spleen health Questions and concerns By Sara Torgerson, DO

he spleen is an organ located in the left upper abdomen, just behind the stomach and directly below the diaphragm. On average, it weighs 150 grams (five ounces). Though we can live without the spleen, it plays important roles in the body as the largest filter of the blood and as a unique and major component of the lymph system. The spleen filters and recycles old red blood cells (oxygen-carrying cells) as well as bacteria and other particles. Broken-down red blood cells release iron in the spleen which can then be used to make

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Minnesota Health care news July • August 2015

fresh red blood cells or be stored in the spleen or elsewhere for future use. A portion of platelets (clotting cells) are also sequestered in the spleen. If the bone marrow, the organ normally responsible for making all of the cellular components of the blood, cannot function properly, the spleen may fulfill that role. As a lymph organ that contains 25 percent of the total lymphoid mass in the body, the spleen fights infections in two distinct ways. It “monitors” the blood and effectively captures and destroys viruses and bacteria directly. White blood cells (immune cells) within the spleen also make proteins called antibodies that can be released rapidly into the blood stream and attack invaders anywhere in the body. What can go wrong with the spleen? Several factors can affect spleen health. Changes in the liver, immune system, or blood system from acquired illnesses, such as infectious processes or cancers, or inherited conditions, such as sickle cell disease or Gaucher disease, can alter the function of the spleen. Trauma can also lead to a malfunctioning spleen. A “sick” spleen can cause symptoms such as pain, nausea, vomiting, fever, or night sweats, or it may cause no symptoms. Your provider may or may not find evidence of a malfunctioning spleen during a routine office visit, but if you have an underlying condition that can be related to development of a malfunctioning spleen, a physical exam and, potentially, bloodwork or imaging may be recommended. Enlarged spleen: During times of infection, the spleen can enlarge significantly and quickly as the infection-fighting cells increase in number. A classic example of this is during infectious mononucleosis, or “mono.” Enlargement of the spleen (splenomegaly) can also occur as a consequence of disease. Liver diseases (i.e., hepatitis, cirrhosis) are common causes of splenomegaly. Blood draining out of the spleen returns to the heart via the liver, so when blood pressure builds in the liver (portal hypertension) due to dysfunction it results in enlargement of the spleen. Underlying cancerous processes (i.e., lymphomas, leukemias); autoimmune diseases (i.e., systemic lupus erythematosus, rheumatoid arthritis); splenic vein blood clots; and Gaucher disease, a rare lipid storage disorder, are other causes. Blood disorders resulting in increased turnover of abnormal red blood cells, such as in inherited or acquired hemolysis (destruction

of red blood cells) cause splenomegaly. If the bone marrow fails, such as in myelofibrosis, then the spleen will enlarge as it becomes the alternate blood-product producer for the body. Cysts and other benign findings (i.e., hamartomas, or noncancerous tumors), can also cause splenomegaly. A proportion of patients with an enlarged spleen will not have any identified underlying cause. An enlarged spleen may not cause any symptoms, or it can cause pain in the left upper abdomen, perceived pain in the left shoulder, a feeling of fullness after small meals, nausea, vomiting, or fever. The blood can include decreased numbers of platelets, as up to 90 percent can become sequestered in an enlarged spleen, and increased numbers of white blood cells. An enlarged spleen may not be detected during physical examination since it typically has to enlarge 40 percent before being felt. Ultrasound or computed tomography (CT) may be recommended for further evaluation. If the factors mentioned above are treated or resolved, the spleen can return to its normal size.

cell anemia). Splenic infarcts are sometimes treated conservatively with pain medicine, and other times require surgical removal of the spleen. Infections, cancers, autoimmune diseases, and other infiltrating cellular processes can also disrupt the function of the spleen. Splenic trauma: Splenic rupture after blunt abdominal trauma— often caused by car accidents, falls, assaults, or sports injuries—can happen immediately or in some cases can be delayed. Atraumatic splenic rupture is uncommon. A ruptured spleen must be addressed on an emergency basis due to the potential for massive hemorrhage and shock, and, depending on the degree of injury, often requires surgical spleen removal. After abdominal trauma, portions of the spleen may spill into other areas of the abdominal cavity and cause “implants” which can, in rare cases, cause an obstruction in the small bowel or hemorrhage. These implants can be found in the chest cavity if there was a tear in the diaphragm during the trauma.

Despite its important functions, the spleen can be removed.

Dysfunctioning spleen: Apart from surgical removal of the spleen, diminished or absent spleen function can develop after repeated injury to the organ. Splenic vein clots cause infarction (tissue death) in the spleen. This can occur with inherited clotting disorders, cancers involving the spleen, trauma, or disorders of hemoglobin (i.e., sickle

Surgical removal of the spleen: Despite its important functions, the spleen can be removed since other organs can assume many of its functions. Apart from trauma, there are other situations in which the spleen might have to be removed. For example, in idiopathic thrombocytopenic purpura (ITP), in which

Spleen Health to page 34

July • August 2015 Minnesota Health care news

physical fitness

Camping It’s healthier than you might think By Commissioner Tom Landwehr

ecognizing the health benefits of spending time in nature, more and more health care professionals are referring patients not just to other doctors, but to Mother Nature. A dose of the outdoors can help treat high blood pressure, depression, or various other ailments.

In Minnesota, we have 75 state parks and recreation areas offering outdoor recreation, natural beauty, and the chance to improve mental and physical well-being. Overnight stays at state parks and recreation areas have increased by more than 10 percent since 2008.

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Minnesota Health care news July • August 2015

Health benefits Camping is a way to get more of the “Vitamin N” (nature) that too many of today’s kids and adults are deficient in, according to Richard Louv, author of “Last Child in the Woods” and “The Nature Principle.” Other physicians stress the important role nature can play in addressing obesity, especially among children. Once you arrive at your campsite, you can burn calories while setting up your tent and going exploring. For a lower-body workout, take a hike or go biking. For an upper-body workout, rent a canoe or kayak and do some paddling. Over the course of a day, a 150-pound person will burn approximately 100 calories per hour while camping. You burn almost 40 percent more calories camping as you would sitting on the couch or at a desk—provided you don’t eat too many s’mores around the campfire at the end of the day! You don’t have to work up a sweat. Sitting still on the shore of a lake or river also can be beneficial. Wallace J. Nichols, PhD, author of “Blue Mind,” writes that “even just the sound of water can make us feel more optimistic and positive about our lives.” The Japanese are so convinced about nature’s restorative powers that they have designated 48 official “Forest Therapy” trails. Hikers take to these trails for a dose of shinrin-yoku, or forest bathing, which they consider to be “standard preventive medicine,” according to an article titled, “Take Two Hours of Pine Forest and Call Me in the Morning” in the November 2012 issue of Outside magazine. Getting out there There’s a state park or recreation area within an hour of almost everyone in Minnesota, so forest—or prairie, if you prefer—therapy trails are easy to reach. With 75 parks to choose from, some people turn to ParkFinder, a new online tool to find a campground with the amenities and recreation opportunities that match their needs and interests. Looking for a Minnesota state park with a swimming beach, a bike trail, and kayak rentals? ParkFinder allows you to enter search criteria, view the results, and make reservations. If you grew up going camping with your family, you may already have a tent in the attic or garage. If, however, you lack the experience or equipment to feel comfortable taking your own kids on such

a trip, consider signing up for one of the many introductory programs offered at Minnesota state parks and recreation areas in 2015. Experienced instructors from Conservation Corps Minnesota will teach you—or provide a refresher on—basic camping and outdoor skills, from setting up a tent to building a campfire and cooking. All camping equipment is provided (including tents, air mattresses, and cook stoves). Participants just bring their own food and bedding (sleeping bags or blankets and pillows). One-night programs are $50; twonight programs are $75 (up to six people per tent). The Minnesota State Parks and Trails I Can! series— made possible with funding from the Clean Water, Land and Legacy Amendment— also includes I Can Paddle!, I Can Climb!, I Can Mountain Bike!, I Can Fish! and Archery in the Parks programs.

whenever you leave your campsite to go exploring: water, nutritious snacks, hand sanitizer, sunscreen, and a first-aid kit. • If you’re going biking, wear a bike helmet; if you’re going boating, wear a life jacket or personal flotation device. Much of what you need to know to have a safe and enjoyable experience outdoors is common sense. Don’t let fear of what could go wrong keep you from reaping the considerable physical and mental health benefits of going camping. This summer, if your family starts showing symptoms of Vitamin N deficiency, go see Mother Nature at a Minnesota state park near you. Discover (or rediscover) the skills and confidence to enjoy the quintessential Minnesota experience of a family campout, and help spark a healthy interest that lasts a lifetime.

If you’re going boating, wear a life jacket.

Not up for tent camping? Perhaps you would prefer to stay in a camper cabin or a yurt instead. Camper cabins are rustic, one-room cabins that sleep five to six people. Many of the cabins have heat and electricity. Yurts—new this year at Afton and Glendalough state parks and at Cuyuna Country State Recreation Area—are round structures with heavy-duty reinforced fabric sides. They are heated with wood-burning stoves but do not have electricity. When staying in a camper cabin or a yurt, you can cook your meals outside at a fire ring and enjoy a “camping out” experience with the security and convenience of bunk beds and a solid, weatherproof roof over your head.

For more information about the I Can Camp! and other I Can! programs—including dates, times, locations, and minimum age requirements—visit www.mndnr.gov/ican or contact the DNR Information Center at info.dnr@state.mn.us or 651296-6157 or 888-646-6367 between 8 a.m. and 4:30 p.m. Monday through Friday. Tom Landwehr is commissioner of the Minnesota Department of Natural Resources.

Health and safety concerns For families busy with soccer, hockey, dance, and other activities, a lack of time may be the primary barrier keeping them from getting away on a camping trip, but for others, the barrier may be health and safety concerns. A little knowledge goes a long way, though. And while there’s always a possibility of a mishap on vacation, even at a hotel with all the amenities, here are some tips for minimizing the risk of illness, injury, and general discomfort while camping.

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• Learn to identify poison ivy, a knee-high shrub with three tell-tale leaflets, which can cause an itchy rash. To avoid contact with this pesky plant, which grows throughout the state, stay on trails and remember the adage, “Leaves of three, let it be.” For a photo and more information, visit the DNR website. • Use insect repellent to deter mosquitos, biting flies, and ticks. A repellent containing DEET is most effective against deer ticks, which are potential carriers of Lyme disease. The DNR also recommends tucking pants into socks (to create a tick barrier), wearing light-colored clothing (to make ticks more visible), and checking for ticks immediately after leaving wooded and brushy areas. For more information, such as how to identify and remove ticks, visit the DNR website. • Wear sturdy shoes. Flip-flops are fine at the beach, but bring more suitable footwear, such as athletic shoes or hiking boots, for hiking on trails so you don’t stub a toe or sprain an ankle. • Load up a waist pack or light backpack with these essentials

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July • August 2015 Minnesota Health care news

Dermatology

Poisonous plant reactions Common Minnesota varieties By Margaret Collins, MD

s we enjoy Minnesota’s natural beauty, we must be aware of certain plants that could ruin camping trips or even a good day of yardwork. Some of these plants, like poison ivy, are well-known, while others, like wild parsnip, are less familiar.

Telephone Equipment Distribution (TED) Program

Poison ivy A common shrub found throughout Minnesota, poison ivy generally grows about knee-high with a single woody stem. Growing in patches up to 20 feet across, it can spread quickly, particularly in disturbed soil, and can invade lawns adjacent to forests. The

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Minnesota Health care news July • August 2015

leaves are always in groups of three and are generally quite shiny in appearance, although they may have small black “dots” scattered on the surface. In the fall the leaves turn an attractive orange to red color. They have non-showy white flowers that develop small white berries. Only humans appear to react to poison ivy; birds eat the berries, and other animals eat the leaves with no ill effects. Poison ivy rashes are caused by urushiol, an oil contained in the sap and in all parts of the plant. Urushiol can get onto the skin through direct contact with the plant, or by coming into contact with anything—including pets, clothing, or tools—that touches the plant. Human skin absorbs the poison ivy’s toxic oil upon contact. A poison ivy rash usually occurs 12 to 24 hours after exposure, although in some cases the reaction can be delayed for a few days. Immediate washing with soap and cold water may prevent the rash (warm water will increase absorption). Later washing can still prevent the spread of the oil to other parts of the body and may limit the rash. The Centers for Disease Control and Prevention (CDC) recommends using lots of water to rinse away the oil. Be sure to clean under fingernails and to wash any clothing exposed to the oil with hot water and regular detergent. The poison ivy rash, a severe form of allergic contact dermatitis, causes severe itching and blisters that may become quite large. The fluid inside the blisters does not contain poison ivy oil and will not spread the rash to other areas. The CDC reports that up to 90 percent of people exposed to poison ivy will develop a rash. They recommend the use of wet compresses, calamine or other anti-itch lotions, and oatmeal baths to reduce itching. Antihistamine pills (diphenhydramine, for example) can help relieve itching and help you sleep. If the rash is severe or is in a sensitive place such as the face, you should see a health care provider. Rarely, the reaction may be severe and cause swelling or breathing difficulty, in which case emergency care should be sought immediately. When poison ivy is burned, the oil may become airborne, where it can be inhaled and cause severe breathing problems, or it may settle on nearby surfaces. The oil may remain on surfaces for at least five years, according to the CDC, so it is important to clean tools and equipment that come into contact with the plant with rubbing alcohol or soap and lots of water.

Poison sumac A small tree related to poison ivy, poison sumac is much more rare. Found in parts of eastern Minnesota, it grows only in very wet areas such as wetlands and bogs. Its leaves and other parts also contain urushiol oil, causing the same reactions as poison ivy. Its bark is smooth and its leaves appear in groups of 7–13 along a stem. The leaves are smooth and the tree develops small white flowers and white berries in the spring. This is in contrast to the non-poisonous and much more common (and unrelated) staghorn sumac, which has velvety bark, “toothed” leaves in groups of 7–13 along a stem, tall cones of small green flowers in the spring, and cones of red berries in the fall.

found in woodland edges and in landscape plantings. It is a perennial weed that can be difficult to eradicate from landscaped areas.

Rashes in the sun Less familiar than the rash caused by poison ivy is the sun-induced rash called phytophotodermatitis, caused by wild parsnips and many other plants. Phytophotodermatitis means a rash caused by the combination of plant material (“phyto”) and sunlight (“photo”) causing a rash (“dermatitis”).

Minnesota is a beautiful place to be in the summertime, but hazards do exist. With proper protection such as long pants and sleeves, and a sharp eye, these common plants can be easily avoided. The Minnesota DNR (www.dnr.state.mn.us/plants) and the University of Minnesota Extension (www.extension.umn.edu) websites have many excellent photos of these plants and information about where they are found and how to rid your yard of them if necessary.

Stinging nettle plants often grow in light-green clusters, with toothed leaves growing along a central stem. All parts of the stem and leaves are covered with long hairs. These hairs are hollow and contain chemicals that cause an immediate hive-like reaction upon contact with the skin. Although it can be quite uncomfortable at first, with stinging, itching, and burning sensations, this reaction lasts only a few hours. Rarely, a blistering rash can occur in the affected area, but the more severe symptoms are short-lived. Generally, no specific treatment is needed beyond cool washcloths and anti-itch lotions.

A poison ivy rash usually occurs 12 to 24 hours after exposure.

Wild parsnip is considered a “noxious invasive weed” by the Minnesota DNR. It is a perennial that has a short “rosette” stage where it grows only six inches high with egg-shaped toothed leaves on a central stalk. During a later “flowering” stage, it can grow up to 4 feet high with a thick stem and a flat-topped flower cluster made of many small yellow five-petaled flowers. The flower cluster resembles Queen Anne’s Lace.

Margaret Collins, MD, is a board-certified dermatologist with Dermatology Consultants.

The sap of wild parsnip plants contains a chemical called psoralen, which can cause a severe reaction on skin exposed to sunlight. Psoralen is also found in lime juice and in many other plants, including giant hogweed (rare in Minnesota, but found as far west as Wisconsin and the upper peninsula of Michigan), members of the carrot family, certain wildflowers, and celery. If you know you have been exposed to the chemical, it should be washed off the skin before any significant sun exposure. According to the Mayo Clinic, the rash often starts with an inflammatory stage where there is a sunburn-like appearance, sometimes with blisters or scaling. The rash may be itchy or painful. It can appear in strange patterns, depending on how the chemical came into contact with the skin. This can include lines or streaks, hand prints, or drip patterns (such as can be seen with “margarita dermatitis,” caused by lime juice dripping on the chin or hands). “Weed whips” may splatter small bits of the plant on the skin, causing small scattered dots. The inflamed stage can last several days, and symptoms can usually be controlled with cool washcloths and anti-itch lotions, although sometimes prescription treatments are needed. Once the inflamed stage fades, it is usually followed by tan to brown discoloration lasting for several months, generally without symptoms. Occasionally, this final discolored stage occurs without the initial inflammatory stage. Stinging nettle The final common Minnesota plant to note is the stinging nettle. Considered an invasive plant by the University of Minnesota, it can be

• Family history of coronary artery disease • Female and post-menopause • Male and over 40 years of age

Contact the study team or ask your physician about SAMURAI to learn more.

radiant Clinical research

www.radiantresearch.com July • August 2015 Minnesota Health care news

Technology

Telehealth A growing trend in medicine By Richard F. Sethre, PsyD, LP

ost people have heard the term “telehealth.” In fact, most people, even if they don’t know about it, are already involved with this new trend in medical care. It’s increasingly common for patients referred for radiology consultations to have their x-rays sent electronically to a radiologist in another building, another part of town, another community, or even another part of Minnesota. The “remote” radiologist views the images online, then reports back to the patient’s home clinic. Also, your medical provider probably uses electronic records instead of paper charts.

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Telehealth services are currently provided by dentists, physical therapists, in-home health care providers, and other medical providers. Routine examples include email communications between patients and their medical providers and the use of video for medical appointments. In what is probably the most controversial version of telehealth, prescriptions are provided by medical providers who have had no in-person contact with the patient—only electronic contact. Even mental health services may now be provided using telehealth technologies, and research finds that patients are as satisfied with video therapy sessions as they are with in-person sessions. Some very anxious mental health patients are even more comfortable with therapy appointments in their home.

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Medical telehealth services are part of a technological revolution that has led to radical changes in devices, infrastructure, and the use of information and data. The most basic, non-revolutionary example occurs when a patient and doctor exchange messages through a patient portal tied to an electronic medical record system. A more radical example would be remote robotic surgery, in which the surgeon sits at a hightech console and, using a video image of the patient and remote control devices, directs a surgical robot to perform the actual operation.

Multiple benefits Telehealth services have several distinct advantages over in-person services. One major advantage is the ability to provide medical services in regions with a shortage of medical providers. For example, Minnesota has a significant shortage of psychiatrists, so some behavioral health programs now offer video sessions with a psychiatrist in a different community, ensuring that the patient receives help and avoids a long-distance drive to see a specialist. Many patients actually prefer to sit at a computer station in their local clinic to consult with a remote specialist, often located in the Twin Cities metropolitan area. Also, patients with busy schedules may prefer telehealth services from their home or office, even if they could see a provider at a community clinic. Another advantage is the ability to provide more intense monitoring between in-person appointments. For example, patients with serious cardiac conditions may use a scale and blood pressure cuff that sends daily results to their cardiac team, which may then respond to changes by asking the patient to come in for an appointment.

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Other conditions increasingly monitored with telehealth services include diabetes and chronic obstructive pulmonary disease (COPD). Patients who have had frequent hospitalizations are often monitored remotely after discharge to help avoid a trip back to the hospital. Patients with a history of not taking their medications consistently may also benefit from telehealth services and monitoring. A less intensive but increasingly popular version of telehealth services utilizes apps to exchange information using smartphones, tablets, and activity trackers. Medical teams may use information from their patient’s devices to refine the treatment plans. Numerous companies now develop apps and devices to monitor both behaviors and symptoms. One of the most radical new telehealth technologies employs tiny devices that may be swallowed, like a pill. The devices monitor the patient’s internal functioning and send information to a transmitter outside of the body, until the device is eventually excreted.

services to have the same quality and standards as in-person services, and to have the same reimbursement. Another challenge is that there are different skills required for the medical professional using telehealth technology, and these skills have only recently become part of medical training. And—obviously—it is a significantly different experience for the patient. Not all patients are comfortable talking to a medical professional on a computer screen, exchanging messages online, and being prescribed or otherwise treated by a medical professional that they have never met in person. One the other hand, younger patients experienced with digital technology (“digital natives”) often prefer telehealth to in-person services, and may even expect to be able to contact their doctor or therapist by email or to have video appointments when their schedule is busy.

Telehealth services may result in significant cost savings.

Disadvantages and challenges Despite these benefits, there are some significant disadvantages and challenges related to telehealth services. One obvious factor is that the technology may be expensive—even very expensive, in the case of remote robotic surgery. Also, some insurance companies do not pay for some telehealth services. The goal, however, is for telehealth

In addition, the definition of “location of services” is different than for traditional medical services. In the past, the location of service was the physical site where the patient and physician met for the appointment. Under telehealth, the location of services may be the patient’s location, posing concerns if the health care provider is in another state. Most states, including Minnesota, require that the medical provider be licensed in the state where the service is being provided.

Telehealth to page 19

Call 1-800-333-HOPE Before you lose what really matters

Gambling problems can only be solved if you have the conversation. Reach out and ask for help before you lose what is really important.

GetGamblingHelp.com July • August 2015 Minnesota Health care news

Calendar Aug.-Sept. 2015 Aug.15

Ataxia Support Group

The National Ataxia Foundation offers this free support group for those affected by ataxia and their loved ones. Come gain insights, support, and new connections. For more information, call (612) 724-3784 or email schultz.lenore@yahoo.com. Saturday, Aug. 15, 10–11 a.m., Langton Place, 1910 W. Cty. Rd. D, Roseville

Compassionate Friends Group

Center for Grief, Loss & Transition hosts this free support group for parents who have experienced the death of a child of any age. Come connect and help support others who are going through similar grieving experiences. For more information, call (763) 542-8528. Monday, Aug. 17, 7–9 p.m., Calvary Lutheran Church, 7520 Golden Valley Rd., Golden Valley

Ovarian Cancer Support Group

Minnesota Ovarian Cancer Alliance offers this Coffee & Connections meeting for women who have been diagnosed with ovarian cancer and their loved ones. Come connect with other survivors. For details or to register, call (612) 822-0500. Tuesday, Aug. 18, 10–11:30 a.m., Minnesota Ovarian Cancer Alliance, 4604 Chicago Ave. S., Minneapolis

Brain Aneurysm Support Group

HealthEast invites people dealing with a brain aneurysm and their loved ones to join this free support group. Enjoy live music and learn to move in a way that energizes you. Registration not required. For more information, call Tess at (651) 326-3415. Thursday, Aug. 27, 12:30–2 p.m., St. Joseph’s Hospital, dePaul Tower 2nd Floor, 3M Conference Center, Conference Room C/D, 45 W. 10th St., Saint Paul

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Email submissions to amarlow@mppub.com or fax them to (612) 728-8601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.

World Hepatitis Day World Hepatitis Day is recognized on July 28 to raise awareness of this global health threat. There are five different types of viral hepatitis—types A, B, C, D, and E. All of these can cause inflammation of the liver, but chronic hepatitis B and C can lead to cirrhosis of the liver or liver cancer. About 240 million people in the world are living with chronic hepatitis B and up to 150 million are living with chronic hepatitis C, according to the World Health Organization. Chronic viral hepatitis is one of the top 10 infectious disease killers in the world. More than one million people die each year because of it, with the majority of deaths due to cirrhosis or liver cancer caused by chronic hepatitis B and C. These account for about 80 percent of cases of liver cancer globally, according to the Centers for Disease Control and Prevention (CDC). The good news is that there are treatments available that cure 90 percent to 95 percent of patients with hepatitis C. And while hepatitis B cannot be cured, there are medical treatments available to help manage it. However, many people live with viral hepatitis for years before they experience symptoms. And during that time, damage is being done to the liver. To take a free online assessment from the CDC and receive personalized hepatitis testing and vaccination recommendations, visit www.cdc.gov/hepatitis/RiskAssessment.

Sep. 8

Hepatitis C Support Group

LiverHope hosts this monthly support group to promote education, generate awareness, and advocate for quality medical care for people living with hepatitis. For more information, call Richard at (763) 780-0108. Tuesday, Sept. 8, 7–9 p.m., Shepherd of the Hills Lutheran Church, 3920 Victoria St. N, Shoreview

Minnesota Health care news July • August 2015

Sep.5

Self Discovery

Metropolitan Center for Independent Living presents this free four-part series for people who would like to learn more about themselves and their disability. Learn how increasing confidence can lead to changes in attitude and strategies to achieve life goals. Call (651) 603-2030 to sign up. Saturday, Sept. 5, 12, 19, & 26, 9–11 a.m., Metropolitan Center for Independent Living, 530 Robert St. N., Saint Paul

Lymphedema Class

Park Nicollet offers this free class for people who are at risk of developing lymphedema from surgical procedures or radiation therapy. Come learn the causes, signs, and symptoms of lymphedema and discuss practices to decrease the risk of developing it. Call (952) 993-5700 to register. Wednesday, Sept. 9, 12:30–1:30 p.m., Park Nicollet Frauenshuh Cancer Center, Curtis and Arlene Carlson Family Community Room, 3931 Louisiana Ave. S., St. Louis Park

Honoring Choices

Hearing Loss Support Group

Fairview Health Services hosts this free class for anyone over the age of 18. 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. Tuesday, Sept. 15, 1:30–3:30 p.m., Fairview Clinics— Bloomington, 600 W. 98th St., Bloomington

Allina Health hosts this free support group for anyone who is hard of hearing. Come meet others in similar situations and gain insights from their experiences. For more information or to sign up, call Bob at (763) 537-7558. Saturday, Sept. 19, 9:30 a.m.–12:00 p.m., Courage Kenny Rehabilitation Institute, 3915 Golden Valley Rd., Minneapolis

outcome measures are better than for in-person treatment. Many patients appreciate the convenience of telehealth services and utilize them more often due to convenience.

Telehealth from page 17

If a Minnesota doctor sees a patient who resides in Minnesota but winters in a Southern state, the doctor will probably need to be licensed in that other state in order to provide telehealth services when the patient is down south. Maintaining patient confidentiality is another major challenge. The federal Health Insurance Portability and Accountability Act (HIPAA) imposes strict controls on the use of confidential medical information, defined in the act as Protected Health Information (PHI). If telehealth services use data that is considered as PHI under HIPAA, then this data must be protected, such as by encrypting it for transmission between the patient and the medical provider. The sheer volume of data that may be generated by remote tracking technologies can be challenging for the medical team to monitor. Identifying an important piece of data, such as a change indicating a life-threatening medical condition, can be like trying to monitor a haystack for the presence of a needle that may or may not be actually buried in the data.

Most people … are already involved with this new trend in medical care.

The medical field increasingly relies on “outcomes measurement,” or research that studies the effectiveness of various treatments. Telehealth services have been studied using outcomes measures for some 30 years, and the results show that the outcomes are often equal to regular, in-person medical services. In fact, for some services, the

Conclusion Telehealth services may result in significant cost savings, once the technology is in place. Patients may not need to travel long distances. Patients with serious or even life-threatening medical problems may receive treatment that better meets their needs. Patients who are having medication problems may be able to receive better monitoring by their medical team, and, as a result, have changes made to their medication to better meet their needs. Studies have shown that all of these factors, coupled with other benefits of telehealth services, help to reduce long-term medical expenses. The combination of good treatment outcomes, patient satisfaction, cost savings, and a population increasingly reliant on digital technology means that telehealth services will be an important part of the emerging healthcare revolution.

Richard F. Sethre, PsyD, LP, is a licensed psychologist and practice management consultant. His Mental Health Concierge blog provides resources for consumers and professionals.

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

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Gallbladder hernia endocrine (parathyroid, thyroid and adrenal) Gastric Reflux bowel (colon resections) oncology/cancer

To schedule an appointment at any of our 13 locations, please call 763-780-6699 or visit www.sgsmn.com July • August 2015 Minnesota Health care news

2015 health care architecture honor roll 20

innesota Physician Publishingâ&#x20AC;&#x2122;s 2015 Health Care Architecture Honor Roll recognizes six outstanding projects in urban and suburban Minneapolis and in Hudson, Wis. This yearâ&#x20AC;&#x2122;s Honor Roll projects include new clinics, medical office buildings, a hospital renovation and addition, a long-term care facility, and senior housing. The medical services range from routine clinic visits to specialized care. Populations served include the standard roster of patients seen at outpatient clinics as well as specialized groups such as children, women, and seniors. Although the facilities differ in intended use and population served, they share a focus on providing a healing environment, cuttingedge technology, and patient privacy. Several projects incorporated sustainability and elements of nature into their designs. Senior accommodations have been designed to encourage independence and a sense of community. Minnesota Physician Publishing thanks all those who participated in the 2015 Honor Roll.

Minnesota Health care news July â&#x20AC;˘ August 2015

Interlude Restorative Suites Type of facility: Transitional care unit addition to Unity Hospital Location: Fridley Client: B enedictine Health System (owns 90 percent) and Allina Health (owns 10 percent)

Architect/Interior design: Horty Elving Engineer: Steen Engineering (mechanical/electrical); Pierce-Pini + Associates (civil)

Contractor: McGough and Yanik

Opposite page: Main entrance Top: Reception desk and bistro Right: Lobby and fireplace

Completion date: January 2015 Total cost: $12,169,080 Square feet: 47,418

nterlude Restorative Suites is a three-story addition to Unity Hospital designed as a premier transitional care unit that focuses on exceptional care, quick recovery, and staff efficiency. Guest rooms were designed with a “no wake” policy in mind so patients can sleep without disturbance. Nurse servers let staff stock supplies for patient rooms from the hallway limiting interruptions. Bathrooms have sliding doors to keep swinging doors out

Episcopal Church Home–The Gardens Type of facility: S killed nursing home/long-term and memory care Location: St. Paul Client: Episcopal Homes of Minnesota Architect/Interior design: T rossen Wright Plutowski Architects

Engineer: Lindell Engineering (mechanical/electrical); BKBM Engineers (structural); Civil Site Group (civil)

Contractor: Benson-Orth Associates Completion date: January 2015 Total cost: $19 million Square feet: 46,200

he Gardens is a seven-story, 60-unit skilled care residence offering long-term and memory care in St. Paul. It is the first nursing home in Minnesota to follow the Green House Model of Care. The residence was designed with six “homes” of 10 residents each, with one home on each floor of the building. Residents have private bedrooms and bathrooms arranged around a central commercial kitchen, dining area with a large, communal table, a hearth room, den, and sunroom. This arrangement encourages interaction between residents and

of the room, and roll-in showers let patients bathe in private. Each floor has an open serving kitchen and personal chef who will cater to a guest’s needs. The therapy space has direct elevator access, so patients can come and go without traveling through public areas. The focus on hospitality and the whole patient experience makes it easy for staff to provide excellent care.

their caregivers. In this setting, residents and staff benefit as they develop meaningful relationships in their daily activities. The Gardens shares a warm-water therapy pool, fitness center, salon, theater, pub, bistro, secure outdoor garden, business center, and meeting spaces with other residences on the Episcopal Homes of Minnesota campus.

Right: Atrium Bottom: Home interior

July • August 2015 Minnesota Health care news

Honor roll 2015 The Cooperage Senior Housing Type of facility: Senior housing Location: M inneapolis Client: CommonBond Communities Architect/Interior design: LHB Engineer: Steen Engineering (mechanical/electrical); Mattson Macdonald Young (structural); Stantec (civil)

Contractor: Watson-Forsberg Completion date: October 2014 Total cost: $8,785,000 Square feet: 64,338

Top: The Cooperage Senior Housing Bottom: Sunroom

This device should be worn at night and is not intended to replace the need to properly test your blood sugar levels with a blood glucose meter.

Minnesota Health care news July â&#x20AC;˘ August 2015

ccessibility, affordability, privacy, and engagement with a larger community were the priorities for the siting, design, and development of The Cooperage Senior Housing project. This 60-unit, energy efficient housing development provides seniors with secure and independent living accommodations. Energy efficient HVAC and lighting systems, rooftop solar panels, and a high-performance building envelope reduce long-term operating costs. Materials were chosen to increase the lifespan of

the building, while reducing the amount of maintenance required. Residents can enjoy sitting in the large sunroom or out in the garden. The private one-bedroom apartments with full kitchens allow for independence. Shared areas such as a serving kitchen, sunroom, and computer lab encourage interaction among residents and build a feeling of community. The Cooperage has heated underground garage spaces and access to the Minneapolis light rail system and the Hiawatha Bike Trail.

Hudson Hospital/HealthPartners Medical Office Building Type of facility: Medical office building Location: H udson, Wisconsin Client: Hudson Hospital and HealthPartners Architect/Interior design: Perkins+Will Engineer: BKBM Engineers (civil/structural) Contractor: McGough Completion date: November 2014 Total cost: Withheld Square feet: 40,000

udson Hospital and HealthPartners wanted a new building on the hospital campus that would accommodate community growth for years to come. Separate from, but physically connected to the hospital, the building accommodates a variety of specialty clinics and outpatient centers operated by Hudson Hospital along with several independent practices. Designed with an expanded sense of space, the building incorporates Feng Shui concepts for a calming environment. A water feature under the stairway to the second

level brings a little bit of nature inside. The atrium has floor-to-ceiling windows to bring in lots of natural light, which invites healing. Wood ceilings assist with wayfinding and hallways are lined with rotating artwork from local artists to promote a healing environment. Exterior design was intended to complement existing hospital buildings and earth tones were chosen to reflect plants, earth, water, sky, and fire.

Do you or a child in your family suffer from depression, ADHD or high levels of anxiety? Torque Release Technique (TRT) is a specialized form of neurological chiropractic. No twisting or turning is involved. This effective, non-invasive, medication-free treatment has produced dramatic results for both children and adults.

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July • August 2015 Minnesota Health care news

Honor roll 2015 Minnetonka Medical Center Type of facility: Medical office building Location: M innetonka Client: MMB Medical Partners Architect/Interior design: bdh+young interiors | architecture Engineer: Krech, O’Brien, Mueller & Associates Contractor: Timco Construction Completion date: October 2014 Total cost: $18 million Square feet: 63,500

M Top: Main entrance Bottom: Waiting room and fireplace

innetonka Medical Center incorporates many sustainable aspects into its design. It has a LEED qualified storm water system, rain gardens to prevent runoff, an abundance of green space, and an efficient building envelope that optimizes energy performance. Low-emitting interior building materials improve indoor air quality and assure a healthier interior. To let an abundant amount of natural light inside, the center core of the building features a two-story

anodized metal curtain wall. The exterior features regional building materials including a natural stone base and brick. The front entrance has a large drive-under canopy that shelters patrons from the weather. The sun-filled lobby features a fireplace, artwork from local artists, a waiting room, and an open staircase. The building houses an urgency center, a family practice clinic, and a specialty clinic with a multimedia conference room at their disposal.

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Minnesota Health care news July • August 2015

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Ness Plastic Surgery Type of facility: Clinic/surgical center Location: W ayzata Client: Ness Plastic Surgery/John A. Ness, MD Architect/Interior design: ESG Architects/Nate Enger Engineer: Anderson Urlacher (structural) Contractor: Welsh Construction Completion date: August 2014 Total cost: $2,272,000 Square feet: 11,250

ooking to expand Ness Plastic Surgery, John A. Ness, MD, purchased a two-story, rundown, overlooked building in Wayzata. The renovation involved cosmetic updates for a modern look and alterations to make it suitable for medical use. The front façade of the building got an updated look including new windows, a sunscreen, and wood siding. The design capitalized on the existing fully mature trees surrounding the property. Wood was used as

a primary element both inside and out to soften the edges of the space, and to visually connect the building to its site. The elevator was enlarged and upgraded, and all the stairs were replaced. The main staircase features wood paneled walls and ceilings. The building features a plastic surgery clinic, a cosmetic surgical center with an accredited surgical suite, and more room for medical spa services.

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Surgery

Hernia Repair New robotic procedures By Mark Reiner, MD, FACS

urgical procedures for the repair of inguinal hernias (the most common hernia type, affecting the groin) have advanced dramatically over the last 20 years. The newest trend employs Intuitive Surgical, Inc.’s da Vinci Surgical System, a robotic tool that allows for smaller incisions, greater precision, lower rates of complications, and quicker patient recovery time when compared to open inguinal hernia repairs.

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

• Diabetes treatment guidelines • Foot wounds • Overactive bladder 26

Minnesota Health care news July • August 2015

By the numbers Inguinal hernias are a pervasive problem in the United States. Males have a 25 percent to 40 percent chance of developing an inguinal hernia in their lifetimes. Females have a much lower rate, accounting for 4 percent of all inguinal hernia repairs. Patients who have an inguinal hernia on one side have at least a 30 percent chance of developing a second hernia on the opposite side during their lifetime. Most groin hernias fall into one of four types: an indirect defect, a direct defect, a femoral defect, and a sports-related defect. The first three are anatomically different, but the repairs remain the same. The sports hernia can often be fixed with the same techniques as the other three defects, but not always. Whatever kind of hernia, it is essential for it to be surgically repaired because a piece of intestine or fat can become lodged in the defect (incarcerated). A surgical repair prevents gangrene (loss of blood supply) of the incarcerated structure. Hernias can also cause severe pain and discomfort, often affecting one’s daily life— physically and cosmetically. Once a hernia is diagnosed, many patients will show no symptoms. However, within two years, 70 percent of those patients will develop symptoms that can be attributed to the defect. The risk of the hernia causing incarceration and gangrene is under 1 percent. Approximately 750,000 inguinal hernia surgeries are performed annually in the U.S. Earlier surgical techniques In the 1970s, most inguinal hernias were repaired on an inpatient basis, with moderate size groin incisions (open technique) requiring up to seven days in the hospital for recovery. Patients were out of work from four to six weeks and had to refrain from significant physical activity for up to three months following their surgery. The recurrence rate of developing another hernia on the same side was between 10 percent and 30 percent. The Shouldice Clinic in Ontario, Canada, started to popularize an outpatient technique for inguinal hernia repair, but this didn’t become popular in the U.S. until the early 1980s. The outpatient technique was an improvement, but patients were still out of work

for a few weeks, and did not return to full physical activity for about one month. Patients still had significant post-operative pain that limited physical activity. Recurrence rates in the best series were slightly under 2 percent, but the average surgeon still had a recurrence rate approaching 10 percent.

in seven to nine days. It is not pain free, but because the patients are encouraged to start limited exercise within the first 24 hours following surgery—and can do so because of reduced pain levels— the discomfort dramatically diminishes, falling off to just mild discomfort on the third post-operative day.

Some 750,000 inguinal hernia surgeries are performed annually.

In 1984, Irving L. Lichtenstein, MD, popularized the “tension free” open hernia repair using synthetic material to bridge the defect in the groin wall caused by a hernia. This technique was less painful, had a quicker return to full activity, and, in good hands, a recurrence rate of only 1 percent to 3 percent. However, patients were still out of work for at least one to four weeks and did not return to significant activity for approximately five weeks. Woundand nerve-related complications also remained significant. Laparoscopic repairs The most significant change in inguinal hernia repair in the last 50 years was the development of the laparoscopic technique in 1990. This new procedure dramatically reduced postoperative morbidity, reduced pain, and limited recovery time. Laparoscopic surgeons insert a thin, lighted tube through a small abdominal incision, allowing them to view the patient’s abdominal organs. With laparoscopy, over 70 percent of patients return to work within three days, and are back to near full activity

Today, only 34 percent of all inguinal hernias are done with the laparoscopic technique, while almost 100 percent of gall bladders removals in this country are done laparoscopically.

The laparoscopic approach is not yet universally used for hernia repairs because surgeons need to complete 200 to 250 procedures before feeling comfortable executing the procedure with minimal surgically related complications and recurrence. Two laparoscopic techniques are used for inguinal hernia repairs: • Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) breaches the abdominal cavity, allowing the surgeon to see all of the abdominal contents. This technique attempts to keep the mesh used for the repair away from the intestine, but this is not always possible. • Total Extraperitoneal Inguinal Hernia Repair (TEP) uses a space developed between the abdominal wall and the Hernia Repair to page 32

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 July • August 2015 Minnesota Health care news

Physical Therapy

Carpal tunnel syndrome Causes and treatments By Kari Paulson, OTR/L and Wendy Camp, OT, CHT

arpal tunnel syndrome (CTS) is the most common and frequently diagnosed nerve compression syndrome. You may experience numbness, tingling, weakness, or other symptoms due to compression of the median nerve, which runs through the arm and enters the hand through the wrist’s carpal tunnel. Not all pain or numbness in the hand is caused by CTS, though.

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CTS affects the wrist and hand, but typically not all of your fingers. Numbness is often worse at night and may awaken you. Symptoms can also be brought on or intensified by activities. It is important to understand the symptoms and effects of this syndrome to differentiate between CTS and conditions that may mimic it, such as diabetic neuropathy. A look inside your wrist The carpal tunnel is a narrow space inside your wrist that is surrounded by bone and covered by a thick ligament called the transverse carpal ligament. This space is filled with tendons from the hand and thumb as well as the median nerve. The ligament has limited stretching ability, so when the carpal tunnel becomes inflamed or swollen, it is unable to accommodate the extra pressure. The result is compression or pinching of the median nerve. CTS symptoms may include numbness, tingling in the thumb, index finger, middle finger, and half of your ring finger. Each individual may experience slightly different symptoms. What are the causes of carpal tunnel syndrome? Many factors can contribute to CTS. The most common of these are: • Posture

• Wrist trauma

• Repetitive tasks

• Force/tight grip

• Vibration

There are also several conditions that may contribute to CTS. These include: • Pregnancy • Arthritis • Diabetes

• Hypothyroidism

Home treatment for mild carpal tunnel syndrome If you have mild symptoms you might try the following home treatment recommendations: • Wear a wrist splint while sleeping to keep your wrist in a neutral position and reduce pressure on your median nerve. You can purchase a wrist splint from most discount stores and pharmacies. Try it on before purchasing; a poorly fitting splint will not be comfortable to sleep with.

• Take frequent breaks from activities for short periods of time: stretch, change positions, or alternate with another activity. If you must perform certain activities—such as driving or lifting heavier items—keep your wrist in a neutral position or wear your wrist splint. • Use a cold pack placed at your wrist on the palm side for 10–15 minutes after activities to relieve pain and swelling. Be cautious to avoid frostbite. (A bag of frozen vegetables makes a great cold pack.) • Use good posture when performing various activities, since rounded shoulders and slouched posture can contribute to nerve irritation throughout the entire arm. Good body mechanics can be key to decreasing carpal tunnel symptoms. Check your workstation to ensure that your wrists are in a neutral position for keyboarding and mousing.

smoothly through the carpal tunnel. A wrist splint may be recommended to better position your wrist in a neutral position, especially while sleeping. They may also use soft tissue manual therapy and modalities to help promote tissue healing. Once your symptoms have subsided your therapist will provide you with strengthening exercises and will teach you how to modify activities to avoid exacerbation of your carpal tunnel symptoms.

Numbness is often worse at night.

• Avoid using the heel of your hand as a hammer. Ouch! Also avoid wearing tight watch bands or bracelets; other bands, even hair binders, can create an external compression. If your mild carpal tunnel symptoms do not resolve within two weeks of home treatment, you should seek further treatment with a hand therapist or physician. Moderate to severe symptoms Moderate symptoms can cause numbness in your fingers to become more frequent or constant, and weakness may develop in the muscles of the thumb. This may cause difficulty with simple tasks such as opening a jar, buttoning/snapping your pants, or even writing. You may feel as if you are dropping things frequently. When CTS is severe the numbness is constant and your thumb becomes weaker due to muscle atrophy. Severe, untreated CTS can lead to permanent damage to your median nerve and permanent loss of muscle strength in your thumb. How is it diagnosed? Early diagnosis and treatment are important to avoid permanent damage to the median nerve. You may chose to consult with a hand therapist, primary care physician, or orthopedic hand surgeon. A comprehensive evaluation will be completed that includes past and current medical history, physical examination of the involved area, and specific tests to determine the effects of tension placed on the median nerve. This information will help determine if in fact your symptoms are affecting the median nerve or if another nerve issue is the culprit. Based on the results of your evaluation, your health care provider will develop the next course of action. What comes next? There are several non-surgical options to consider:

You may be asked to take NSAIDs (nonsteroidal anti-inflammatory drugs) to help reduce inflammation and soft tissue swelling in the carpal tunnel.

Your physician may recommend an EMG (electromyography) and nerve conduction study to further investigate how well the nerves respond when the muscles are stimulated, or to determine the severity of the nerve compression (mild, moderate, or severe).

A cortisone injection may be suggested to help reduce swelling and ease the pressure within the carpal tunnel. Though the results may be temporary, the relief could last from weeks to months and beyond. It varies with each individual. How do I know if I need surgery? Surgery is indicated if all other treatment options have not provided Carpal Tunnel Syndrome to page 30

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A hand therapist can help you relieve symptoms by providing a home exercise program including stretches, tendon and nerve glides (nerve exercises to allow the nerve to glide smoothly through the carpal tunnel), as well as identifying potential contributing factors. It is important to keep the hand tendons and median nerve gliding July • August 2015 Minnesota Health care news

Carpal Tunnel Syndrome from page 29

relief of your symptoms, if your symptoms are severe, or if you have a sudden onset of numbness, tingling, and pain. Your physician will discuss which procedure would be best for you. The procedure is typically a same-day surgery. Your physician will discuss which surgical procedure would be best for you. How long will it take to heal? The healing time varies from person to person. Most people feel comfortable using their hand one to two weeks post surgery for light activities such as feeding or dressing. Once your sutures have been removed, you may be referred to hand therapy to address post-surgical pain and inflammation, as well as any functional limitations. Your care provider can also address your range of motion and scar management. Therapy typically ranges from four to eight weeks. Although symptoms may be relieved following surgery, full recovery from the surgery can take months. The more severe your symptoms were presurgery, the longer your recovery process.

the longer it may take to get back, or you may be advised to return to work on light duty. Summing up Understanding the basics of CTS is important. Here are a few pearls to keep in mind if you are experiencing numbness or tingling: • You may have CTS if you experience numbness, tingling, and/ or pain in your thumb, index finger, middle finger, and half of your ring finger. • Wearing a wrist splint when you sleep can reduce your CTS symptoms.

Early diagnosis and treatment are important.

Your physician will assist in your return to work. Your time off will be dependent on your job responsibilities. The lighter your job the sooner you may be able to return to work; the heavier the job,

• M ild CTS symptoms typically respond well to hand therapy/conservative treatment. • Surgery is indicated if your symptoms do not respond to conservative treatment, if your symptoms interfere with your daily routine, or if you have a sudden onset of numbness, tingling, and pain.

• Discuss questions or concerns with a health care provider. Kari Paulson, OTR/L, is an occupational therapist specializing in hand therapy. She treats patients at the Stillwater Clinic location of OSI Physical Therapy. Wendy Camp, OT, CHT, is an occupational therapist and a certified hand therapist. She treats patients at the Maplewood and Forest Lake Clinic locations of OSI Physical Therapy.

Center for Sexual Health Compassionate patient care in sexual health for individuals, couples and families of all backgrounds and ages. Patient assessment and treatment is available in the areas of relationship and sexual problems therapy, compulsive sexual behavior, sexual offending, transgender health services and sexual abuse. HIV counseling, as well as psychological treatment for people living with HIV/AIDS. Our physicians provide care for many medical conditions including (but not limited to) the following: • Compulsive sexual behavior

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Hernia Repair from page 27

peritoneum, a lining that surrounds the intestines, meaning that they are not visible during the procedure. It is considered safer because it keeps the mesh out of contact with the intestines. It also allows a larger piece of mesh material to be placed without difficulty, preventing inadvertent bowel injury and minimizing post-operative bowel obstruction. The da Vinci robot The da Vinci robot eases the steep learning curve required for both laparoscopic procedures and offers additional benefits for surgeons. The da Vinci robot’s 3D optics, image magnification, and 360-degree range of rotation (compared to the 180-degree rotation of “straight stick laparoscopy”) allow the surgeon to operate with a precision comparable to the much larger surgical openings of open techniques.

position. To prevent this, many surgeons anchor the mesh in place with metallic staples or tacks, which may increase the risk of nerve injury or chronic pain, especially in inexperienced surgical hands. The robot makes sewing the mesh with absorbable material an easier option, helping to minimize complications.

A precision comparable to the much larger surgical openings.

The da Vinci robot’s optics and controls also make the procedure simpler to master for surgeons who are not trained or adept in laparoscopic hernia repairs. During a laparoscopic repair the mesh may occasionally move or migrate from its anatomically correct

Advantages The da Vinci robot has simplified the technical aspects of the TAPP approach, but until recently was not an option with the TEP approach. In 2014, approximately 50 percent of the laparoscopic repairs were done as TEP and 50 percent as TAPP. Laparoscopic repairs are safe, with low recurrence and complication rates when performed by welltrained and experienced surgeons.

The da Vinci robot will make it easier for surgeons to develop this training and experience, and to offer their patients the best procedures with the lowest complication rates, earliest return to work, and quickest time until full activity. Mark Reiner, MD, FACS, is a clinical professor in both surgery and obstetrics, gynecology, and reproductive medicine in New York City at the Icahn School of Medicine and the Mount Sinai Healthcare System. He also practices at the Midtown Surgical Center in Manhattan.

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. I understand what is meant by the term bioethics.

50 40

2. I believe bioethics should be established and maintained as a field without political or economic attachment.

3. I believe bioethics should play a role in the development of health care policy.

30 25

30 20 10 0

Strongly agree

Agree

No Disagree Strongly opinion disagree

4. I believe a patient should have access to a bioethics professional if they need assistance in making a complex medical decision.

Agree

No Disagree Strongly opinion disagree

Strongly agree

Agree

No Disagree Strongly opinion disagree

Strongly agree

Agree

No Disagree Strongly opinion disagree

5. I believe bioethics is an important area that needs to be developed further.

Strongly agree

Minnesota Health care news July • August 2015

Agree

No Disagree Strongly opinion disagree

For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.

Minnesota

Health Care Consumer Association

Welcome to your opportunity to be heard in debates and discussions that shape the future of health care policy. There is no cost to join and all you need to become a member is access to the Internet.

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

www.mnhcca.org

Join now.

“A way for you to make a difference” July • August 2015 Minnesota Health care news 33 NOVEMBER 2012 MINNESOTA HEALTH CARE NEWS 33

Spleen Health from page 11

platelets are inappropriately removed from circulation by the spleen causing increased bleeding, splenectomy can increase platelet counts and decrease the risk of bleeding. In some circumstances splenectomy may be recommended to diagnose the cause of an enlarged spleen or for cancer treatment. Some 25,000 splenectomies are performed annually in the U.S. This procedure is complicated by the spleen’s proximity to the diaphragm, stomach, pancreas, left kidney, and large intestine. Serious complications after spleen removal include infections, hemorrhage, significant increases in platelet counts, blood clots, and pancreatitis, with complication rates as high as 50 percent. Patients without spleens (asplenic): Without a regularly functioning spleen, patients are at increased risk of severe infections that can be life-threatening. Infectious organisms that are encapsulated by a protective capsule are of particular risk since they can evade most other aspects of the immune system. These bacteria include streptococcus, Hib, and meningococcus. Those at greatest risk are children and anybody during the first two years after splenectomy. Risks of infection and death from infection are elevated for more than 10 years after spleen removal. People with decreased or insufficient spleen function are less at risk than those who have had their spleen surgically removed. Complications after splenectomy Infection after splenectomy can be sudden and rapid. Symptoms could include fever, chills, sore throat, muscle aches, vomiting, or diarrhea; in some cases pneumonia or meningitis are present.

People who do not have a functioning spleen or those who have undergone a splenectomy should receive the pneumoccal polysaccharide vaccine, the meningococcal polysaccharide vaccine, the Hib vaccine, and the annual influenza vaccine. In children under five, daily preventive antibiotics are recommended. In adults, daily antibiotics are not necessary unless they have survived a severe infection previously or are in the initial one to two years post-splenectomy. Any patient without a spleen who develops fever or severe symptoms needs to be evaluated urgently and prescribed antibiotics. Dog and deer tick bites should also be addressed with antibiotics as these can also cause serious infections for asplenic patients. Other risks for asplenic patients include blood clots and an increased risk of cancers due to the loss of important immune surveillance processes. Conclusion The spleen is an important organ for the blood and immune system. Clinical scenarios may warrant splenectomy, however this procedure must always be weighed against the immediate and long-term effects of spleen removal. Vaccination, patient awareness of signs and symptoms of infection, and early administration of antibiotic therapy for fever are extremely important for asplenic patients to avoid life-threatening illness. For more information regarding vaccinations for asplenic patients, visit www.cdc.gov/vaccines/acip/. Sara Torgerson, D.O., is board certified in hematology, medical oncology, and internal medicine and is an employed physician of Minnesota Oncology at the Saint Paul Cancer Center.

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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

Minnesota Health care news July • August 2015

S:9.75”

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

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