MN Healthcare News July 2016 by Minnesota Physician Publishing

July 2016 • Volume 14 Number 7

Dental Health By Alan Law, DDS, PhD, and Lowell Reither, DDS

Sjögren’s syndrome By Umbreen Hasan, MD, FACR, FACP

Conscious sedation By Paul Sorajja, MD, FACC, FAHA, FSCAI

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CONTENTS

4 7 8

JULY 2016 • VOLUME 14

Chickenpox Less common, but still a concern

PERSPECTIVE

16 18

CALENDAR

Transcatheter aortic valve replacements Paul Sorajja, MD, FACC, FAHA, FSCAI

ORAL HEALTH

Dental disease A look at some common problems

By Alan Law, DDS, PhD, and Lowell Reither, DDS

A new way to pay for health care

S ix outstanding building projects

By MPP Staff

RHEUMATOLOGY

10 QUESTIONS

Value - Based Reimbursement:

2016 HEALTH CARE ARCHITECTURE HONOR ROLL

Sjögren’s syndrome An autoimmune condition

By Umbreen Hasan, MD, FACR, FACP

RADIOLOGY

Lung cancer screening Minneapolis Heart Institute Are you a candidate? at Abbott By Aaron Binstock, MD Northwestern Hospital

FORTY-SIXTH SESSION

By Vijay Chawla, MD, FFAP, and Nancy Ott, MD, FAAP, FAAAAI

PEOPLE

University of Minnesota

MINNESOTA HEALTH CARE ROUNDTABLE

PEDIATRICS

NEWS

W hat happens to your medications? A problem of growing concern Lowell J. Anderson, DSc, FAPhA

NUMBER 7

BEHAVIORAL HEALTH

East African culture and mental health Blending two worlds By Ahmed M. Hassan, MA, LPCC

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

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

Background Background and Focus: As initiatives driven by federal health care reform is reform move forward, the term “Value-Based Reimbursement” (VBR) is being mean? being applied to a wide spectrum of issues. But what does this mean? CMS what CMS is developing measurements, well over 150 to date, to define what “value” means in health care. It is proposed that these metrics will be “value” be used element used to create incentives that pay more for better care in every element of and of health health care delivery. Hospitals, physician practices, home care, and long-term care will all be reimbursed by an emerging new math. long-term Objectives: Objectives: We will explore the motivations behind this changing approach approach to reimbursing health care. We will examine what is being being measured and what value really means. We will discuss the arguments arguments that claim VBR is a bad idea and those that believe it is the the best solution. We will discuss how a collaborative, transparent system, and system, that integrates care teams, health information technology and improved access improved reimbursement methods will help achieve increased access to to high-quality, high-quality, cost-effective care for patients. Panelists Panelists include: • Curtis Hanson, MD, Chief Medical Officer, Mayo Mayo Medical Laboratories • Allison LaValley, Executive Director, athenahealth athenahealth Sponsors Sponsors include: • athenahealth • Mayo Medical Laboratories

Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc.

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JULY 2016 MINNESOTA HEALTH CARE NEWS

NEWS

Richfield High School to Offer Mental Health Services Richfield High School has implemented a new mental health services program for adolescents through a partnership with Park Nicollet Foundation, Park Nicollet Health Services, Richfield School District, and Cisco. Park Nicollet’s program, called No Obstacles to Wellbeing (NOW!), allows students who face transportation, financial, or language related barriers to mental health care to access services through secure video technology located in the resource center at Richfield High School. The Richfield Health Resource Center serves children who live, or go to school, in Richfield, from birth through high school graduation. NOW! helps students get care for mild mental health conditions such as depression anxiety, parental chemical dependency, abuse, abandonment, ADHD, and grief support. The program began at St. Louis Park Middle School in 2014 and

launched at Richfield High School in early June with 14 students who were identified to participate. The expanded program now includes a Spanish-speaking therapist.

HCMC Study to Focus on Traumatic Brain Injury Medication Hennepin County Medical Center (HCMC) has notified the public that it is taking part in a multi-site clinical study to test whether people who experience life-threatening or life-altering traumatic brain injury have better outcomes when they receive Tranexamic Acid (TXA), a medication used to stabilize bleeding in the body. HCMC admits and treats the most traumatic brain injuries in Minnesota. The study is being conducted at 12 Level 1 trauma centers in North America. Researchers will analyze the results to determine if TXA, when given as soon as possible after an injury, improves the mental recovery for patients who have experienced traumatic brain injury.

MINNESOTA HEALTH CARE NEWS JULY 2016

Paramedics will determine if a patient is eligible to take part in the study by using information such as blood pressure, pulse, injury type, and cognitive level. Those who enroll will randomly receive one of two combinations of TXA or a placebo (plain salt water) by paramedics and in the hospital. One group will receive a onegram dose of TXA by paramedics and another one-gram dose in the hospital; another group will receive a two-gram dose by paramedics and the placebo in the hospital; and the third group will receive the placebo by paramedics and in the hospital. All other treatments will be the same for all patients. Those who choose not to participate will have the best course of care determined by their physicians. However, because traumatic brain injury often means a patient is unconscious, permission to participate in the study isn’t likely to be obtained before the patient is enrolled. HCMC’s Human Subjects Research Committee has granted an exception from consent for emergency research, which allows paramedics

to enroll a patient without prior consent. According to HCMC, leaders of the study will conduct community consultation meetings to determine if the community is in support of the research. Patients can also opt out by contacting the study staff and asking for the optout wristband, which indicates to paramedics that the wearer does not want to be enrolled in the study.

Minnesota Fourth Best State for Senior Health Minnesota has been ranked as the fourth healthiest state for seniors, according to United Health Foundation’s 2016 America’s Health Rankings Senior Report. It ranked third in 2015. The report compares the health of middle-aged Americans in 2014 to middle-aged Americans in 1999 and analyzes broad health concerns for the generation and the potential strain on the Medicare program and overall health care system. Researchers use data from more than a dozen government agencies and

research organizations, including the U.S. Department of Health and Human Services, the U.S. Department of Commerce, the U.S. Department of Labor, The Dartmouth Atlas Project, the National Foundation to End Senior Hunger, and the Commonwealth Fund. Results this year show that rates of diabetes and obesity are increasing among middle-aged Americans (those 50 to 64 years old), and show a massive growth in the senior population over the next 15 years. The authors note that these statistics “are likely to significantly affect the health and quality of life for the next generation of seniors.”

percentage of seniors with a dedicated care provider (ranked 41 with 91.8 percent of adults ages 65 and older); a high percentage of low-care nursing home residents (ranked 40 with 15.1 percent of residents); and a high prevalence of excessive drinking (ranked 40 with 8.1 percent of adults ages 65 and older).

Patients Report Benefits from Medical Cannabis

A recent survey of patients enrolled in Minnesota’s medical cannabis program during its first three months shows that most patients experienced benefits from the mediOverall in the U.S., Massachucation. The Minnesota Department setts was the number one healthof Health conducted the voluntary iest state for seniors, followed by Vermont in second, New Hampshire survey, which asked patients to rate their level of benefit from one to sevin third, and Hawaii in fifth. Louen. Scores of one to two indicated isiana ranked as the least healthy no or little perceived benefit, scores state for older adults, preceded by of 3 to 5 indicated mild or moderOklahoma in 49th, Mississippi in ate perceived benefit, and scores of 48th, Arkansas in 47th, and West six or seven indicated significant Virginia in 46th. benefit. The survey was sent to 435 “As a geriatrician, I see certain patients who purchased their first health conditions ‘snowball’ as peo- medical cannabis medication during ple age — that is, smaller problems in the first three months of the promiddle-age can get much larger and gram. Of those, 241 responded. more complicated, affecting overall The results show that 90 percent health much more as we age,” said of patients reported a score of three Rhonda Randall, DO, senior advisor or greater. About 20 percent reportto United Health Foundation and ed non life-threatening side effects chief medical officer and executive such as dizziness, lightheadedness, president of UnitedHealthcare Retiree Solutions. “The America’s Health fatigue, feeling high, sleepiness, stomach pains, burning sensations Rankings Senior Report is a call in the mouth, and paranoia. Two to action, particularly as we look percent reported an increase in at the data for the next generation seizures. The largest reported drawof seniors. We must work together — across states, communities, and back of the program was affordability, with 73 percent of patients the public health sector— to find ways to continue improving delivery saying the cost was unaffordable. The top three conditions patients of care to seniors and encourage used the medication for were severe wellness and health among both muscle spasms, seizures, and cancer. current and future seniors.” Cancer had the highest reported Minnesota ranked number one benefit scores. in overall outcomes for seniors. “These survey data are based Strengths among all of the measures on a small sample of patients and include a low prevalence of food should not be confused with a insecurity (ranked first with 8.3 percent of adults ages 60 and older); clinical trial,” said Ed Ehlinger, MD, Minnesota commissioner of ready availability of home health health. “However, these results do care workers (ranked second with 268.3 workers per 1,000 adults ages highlight Minnesota’s data-focused 75 and older); and a high percentage approach to medical cannabis and of dental visits (ranked second with the fact that patients are benefiting from the program.” 75.6 percent of adults ages 65 and older). Challenges include a low News to page 6

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News from page 5

The survey was also sent to 345 health care practitioners who certified patients as eligible for medical cannabis. Of those surveyed, 94 practitioners responded on behalf of 169 patients. About 77 percent reported seeing scores of three or higher for their patients.

58 percent (from 10,672 births to 5,420 births). From 2013 to 2014, pregnancy rates decreased 8.2 percent and birth rates declined 8.1 percent. For adolescents under the age of 15, pregnancy rates declined 7 percent and birth rates decreased nearly 26 percent from 2013 to 2014. Rates in 2014 are the lowest ever recorded in Minnesota.

Minnesota’s teen pregnancy and birth rates have reached historic lows, according to results of the University of Minnesota’s Healthy Youth Development* Prevention Research Center (HYD*PRC) 2016 Minnesota Adolescent Sexual Health Report. The report focuses on the most recent sexual health data and statistics for youth ages 15 to 19.

Gonorrhea rates showed a decline, from 218 cases in 2014 to 174 in 2015, while chlamydia rates remained about the same with 1,402 cases in 2014 and 1,403 in 2015. Sexually transmitted infections strike 7 percent of the general population in Minnesota, but adolescents ages 15 through 19 accounted for 24 percent of chlamydia cases and 16 percent of gonorrhea cases in 2015. There were 12 new cases of HIV among adolescents ages 13 through 19 in 2015, a decrease of 29 percent from 2014 when there were 17 new cases diagnosed.

Between 1990 and 2014, pregnancy rates declined 66 percent (from 17,272 pregnancies to 7,122 pregnancies) and birth rates declined

Geographically, the highest birth rates among adolescents ages 15 through 19 were found in Watonwan, Mahnomen, and Cass

Adolescent Pregnancy and Birth Rates Hit All-Time Lows

counties. All 10 counties with the highest teen birth rates were in greater Minnesota. The highest rates of chlamydia were found in Mahnomen, Hennepin, and Ramsey counties, and the highest rates of gonorrhea were found in Olmsted, Ramsey, and Cass counties. The report shows that racial and ethnic disparities, sexual orientation, and adverse childhood experiences were strong predictors of increased rates of negative sexual health outcomes.

Families of Stillborn Children to Receive Tax Credit Gov. Mark Dayton has signed into law a bill that provides a one-time tax credit to families of stillborn children (unintended fetal death occurring after 20 weeks of pregnancy). Minnesota is the fifth state to enact the legislation. Nearly 400 Minnesota babies are lost to stillbirth each year, and 26,000 nationally.

Effective Jan. 1, 2017 a family who has a stillborn baby is eligible for a one-time, $2,000 tax credit. To receive the tax credit, families must request a Certificate of Birth Resulting in Stillbirth and provide it to their tax professional when preparing the year’s taxes. The tax credit will help to cover financial burdens such as money spent preparing for the child’s arrival, funeral services, time missed at work, and counseling. Some families pay out of pocket for autopsy costs as well, since stillborn children are not typically covered by health insurance. According to the Star Legacy Foundation, a national nonprofit that led the effort to pass the bill, total costs associated with losing a child to stillbirth can reach as much as $15,000. “This bill is about more than dollars and cents,” said Lindsey Wimmer, executive director of the Star Legacy Foundation. “It’s about recognizing the hundreds of Minnesota families that suffer in silence each year.”

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

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UCare for SeniorsSM lets you choose from plans that cover prescription drugs, travel, eyewear, dental, fitness programs like Healthways SilverSneakers® Fitness and more. There are low or no co-pays for primary care visits with most plans. And you’ll get to talk to a real person 24/7 when you call customer service. It’s just what you’d expect from health care that starts with you. Learn more about the benefits of UCare for Seniors in our new eGuide to Medicare at ucareplans.org. Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534, 8 a.m. to 8 p.m. daily.

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

9/14/15 9:03 AM

PEOPLE Marilyn Peitso, MD, FAAP, pediatrician at CentraCare Clinic, has received the 2016 Distinguished Service Award from the Minnesota Chapter of the American Academy of Pediatrics (MNAAP) for her dedication to improving care for children in Minnesota. Peitso has been a pediatrician for more than 30 years. Before joining CentraCare Clinic in 1991, she served as president of the MNAAP. Currently, she Marilyn Peitso, serves on the Minnesota Medical Association’s board MD, FAAP of trustees and foundation board. She is involved in quality improvement efforts in primary care and pioneered the development of Medical Homes for children with special health care needs at local, state, and national levels through the Minnesota and National Pediatric Medical Learning Collaboratives. She has also recently been appointed by the governor to the Minnesota Task Force on Health Care Financing. Peitso earned her medical degree at the University of Minnesota Medical School and completed a residency in pediatrics at the University of Iowa Hospitals and Clinics.

Love

Claire E. Wilson has been named assistant commissioner for the Community Supports Administration at the Minnesota Department of Human Services (DHS), which includes all DHS behavioral health policy areas, including the divisions of mental health, alcohol and drug abuse, disability services, deaf and hard of hearing services, and housing and support services. Wilson has more than 20 years of experience Claire E. Wilson in public policy and most recently served as executive director of the Minnesota Association of Community Mental Health Programs. She also cofounded Capitol Pathways, a paid internship program for students of color, and serves on the boards of directors for organizations focused on helping homeless youth and GLBTQ communities. Matthew E. Bernard, MD, cofounder and medical director at The Center Clinic in Dodge Center, has received the Rural Health Hero award from The Minnesota Department of Health, Minnesota Rural Health Association, and Duluth-based National Rural Health Resource Center. The organizations recognized public health workers for their service to the state’s rural communities and residents at the Matthew E. Minnesota Rural Health Conference in June. The Bernard, MD Center Clinic is a volunteer-based, nonprofit clinic that provides teens, children, low-income, uninsured, and underinsured people with physical and mental health care, counseling, and education. Bernard also serves as the chair of the department of family medicine at Mayo Clinic and as associate professor of family medicine at the Mayo Clinic College of Medicine. Bernard earned his medical degree at the University of Minnesota and completed his residency in family practice at the Mayo Graduate School of Medicine, Mayo Clinic College of Medicine. Megan Rodger, RN, of Bethesda Hospital, has received the Good Catch for Patient Safety Award from the Minnesota Hospital Association for speaking up to prevent a potential patient safety issue. Rodger was honored for taking action to prevent an error in the administration of an intravenous (IV) medication. While preparing the IV tubing, she noticed that the medication bag that listed her patient’s name on Megan Rodger, RN its identification label also had another label with a different patient’s name. A barcode scan showed that the labeled medication was actually a different medication meant for the other patient. Rodger then checked the other IV bags in the refrigerator and found another medication bag that was correctly labeled for her patient. She gave the improperly labeled medication to the charge nurse and reported the discrepancy. Rodgers earned her registered nursing degree at Anoka-Ramsey Community College.

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Care Beyond Cost.

JULY 2016 MINNESOTA HEALTH CARE NEWS

PERSPECTIVE

What happens to your medications? A problem of growing concern

hat portion of a prescription medication ends up in our water supply? Consider that about 2.5 million pounds of amoxicillin was sold in the U.S. in 2009. Eighty-six percent of amoxicillin is excreted unchanged in urine. Less than 2 percent of amoxicillin is removed by water-treatment facilities. That means that 2,100,000 pounds of amoxicillin enter the environment every year! As patients and consumers, we bear some responsibility for that.

Lowell J. Anderson, DSc, FAPhA University of Minnesota Mr. Anderson is a pharmacist who formerly practiced in Falcon Heights and White Bear Lake. After leaving practice in 2006, he joined the faculty of the College of Pharmacy at the University of Minnesota. He is a professor in the Department of Pharmaceutical Care and Health Systems and co-director of the Center for Leading Healthcare Change. He has served as president of the Minnesota Pharmacists Association, Minnesota Board of Pharmacy, and the American Pharmacists Association.

Medicines are designed to affect living organisms— they kill unwanted bacteria and viruses, alter metabolism, or change hormonal balances. They can have similar effects on other life forms when they enter our lakes and streams. We know that the presence of five parts per trillion of common contraceptive medications can cause the collapse of fish populations and that low concentrations of antidepressants in water can alter fish reproductive behavior. We can document DEET (mosquito repellent) in 76 percent of sampled Minnesota lakes, amitriptyline (antidepressant) in 28 percent of studied lakes, and triclosan (anti-bacterial used in household items) in treatment plant effluent.

Certainly medications that are “thrown out” contribute to these numbers. Those unused prescription medications that are out-of-date and thrown in the trash or flushed down the toilet may eventually end up in surface water or in the preload for water treatment plants. Much of what goes into treatment plants comes out the other side into ground water or as drinking water. We have gotten better about offering public “take-back” programs for unused medicines. State legislation passed in the 2016 session may make it easier for consumers to dispose of unwanted medications. The other source of water pollution is by active drug ingredients or metabolites (substances formed by digestion or other bodily processes) that humans and animals excrete in urine and feces. The majority of all medications that are consumed by consumers are excreted in the urine in unchanged condition or as metabolites. Even topical medications such as DEET can enter sewage through bath water. Most water treatment facilities are not designed to remove these products. The bottom line is that we know these products are there but do not know the full risk to the environment and humans. All medicines are inherently hazardous. “Hazard” considers these inherent environmentally damaging characteristics in terms of their ability to resist degradation in the aquatic environment, accumulation of these chemicals in fatty tissue of aquatic organisms, and the potential to poison aquatic organisms.

MINNESOTA HEALTH CARE NEWS JULY 2016

Minnesota’s leadership in addressing the problem

There are several Minnesota agencies working to define the issue of medicines in the environment and find ways to minimize the impact: Minnesota Pollution Control Agency, Minnesota Department of Health, One Health MN Antibiotic Stewardship Collaborative, Grand Portage Indian Reservation Ecosystem Health Collaboration Group, Minnesota Board of Pharmacy, and the College of Pharmacy at the University of Minnesota. Also, countries such as Sweden publish material that aids physicians, pharmacists, and consumers in choosing medications that meet patient needs with the least risk to the environment. The 2014–2015 edition is available at http://bit.ly/28YnheA.

2,100,000 pounds of amoxicillin enter the environment every year!

How does contamination occur?

Hazard vs. risk

The challenge is to understand which products pose an environmental risk. “Risk” is different than “hazard.” Risk considers the degree of hazard of the product and how much of a product is used in a geographic area and how much it is diluted in the geographic water supply.

What can consumers do?

As citizens who use over-thecounter (OTC) or prescription medicines we can have an impact.

• Ask your physician or pharmacist about proper disposal of unused medication. • Use the ‘Rethink Recycling” website, which lists the locations of take-back facilities (www.rethinkrecycling.com). • Buy OTC medicines in quantities that you will reasonably use. • Even though your health plan may encourage a 90-day supply, restrict new prescriptions to no more than 30 days. Take advantage of starter packs if your health plan allows them. • If your insurance benefit is one that does not allow starter-pack prescriptions, ask your pharmacist to allow you to partially fill the prescription for a new medicine. See if it works for you before you stock up. • Keep your medicine cabinet free of surplus prescription and OTC medicines. When you finish taking a medication drop it in the nearest disposal box.

Conclusion

Medicines are important contributors to human and animal health. They are also, by design, powerful chemicals that should be used wisely. Each time you receive a prescription you have the choice to be a wise user: to take the medication only as prescribed, buy the amount that is needed, and dispose of any surplus medication in a responsible manner. Walleye laced with mosquito repellent and hormones is a bizarre food we probably shouldn’t try!

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

If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. To make a referral or for more information, call us at To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota. (888) GSS-CARE or visit www.good-sam.com/minnesota.

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

JULY 2016 MINNESOTA HEALTH CARE NEWS

10 QUESTIONS

Transcatheter aortic valve replacements Paul Sorajja, MD, FACC, FAHA, FSCAI Dr. Sorajja is a cardiologist, researcher, and director for the Center for Valve and Vascular Heart Disease at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and director of the Valve Science Center at the Minneapolis Heart Institute Foundation. Please describe aortic valve stenosis and the valve replacement surgery now performed under conscious sedation. Aortic stenosis refers to a narrowing in the heartâ&#x20AC;&#x2122;s aortic valve, causing restricted blood flow to the rest of the body. It is a very common, life threatening condition, particularly among our aging population. Once symptoms begin, the survival rate is only one to two years, worse than that of many malignancies, including advanced breast cancer. In Minnesota, there are over 25,000 people with severe aortic stenosis. Surgery can be lifesaving for these patients, but, for a variety of reasons, the vast majority of people with aortic stenosis go untreated. Given the large number of these individuals and the availability of therapy for the entire spectrum of surgical risk, untreated aortic stenosis should be considered a public health crisis. Unlike open heart valve replacement procedures that require entry through the sternum or the use of heart-lung machines, transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure that allows surgeons to insert the replacement valve via a catheter inserted into the legâ&#x20AC;&#x2122;s large femoral artery or other blood vessel, guiding it into position in the heart. The major benefits of TAVR are low surgical risks; discharge periods of one to two days; and, when performed in skilled centers, procedural mortality rates of only 1 to 2 percent. This is remarkable given the high-risk nature of many patients with aortic stenosis. TAVR is available for all patients who are at high risk for open surgery. Patients who are at low or intermediate risk can have TAVR by participating in current research trials. TAVRs can be performed under general anesthesia, but for many patients, including the elderly, conscious sedation is the preferred option.

photo credit: Greg Christensen

MINNESOTA HEALTH CARE NEWS JULY 2016

How does conscious sedation differ from general anesthesia? Conscious sedation started several years ago to minimize morbidity for patients undergoing TAVR. It is distinct from general anesthesia, and is not the same as monitored anesthesia care (MAC). The sedatives in conscious sedation are even less than what one typically administers for an endoscopy. Patients receive a narcotic analgesic, a benzodiazepine to help relax, and a local anesthetic to relieve pain at the vascular access site. They remain conscious during the operation, and can actually participate in the procedure by telling surgeons how they are feeling. Unlike general anesthesia, there is no need to intubate the patient, and the impact on mentation and its recovery is minimal. Conscious sedation is routinely administered by a registered nurse, certified registered nurse anesthetist (CRNA), or anesthesiologist. Conscious sedation TAVR is available at only a few centers across the country, and itâ&#x20AC;&#x2122;s the principal way we do our procedures at the Minneapolis Heart Institute at Abbott Northwestern Hospital. Which patients are the best candidates for TAVRs performed under conscious sedation? Patients who have TAVR are typically elderly, frail, and can have a number of challenges with post-operative recovery. Many patients prefer to avoid intubation, and seek the faster recovery periods and pain control that occurs with conscious sedation. This motivation is very helpful, as patients need to lie still during the procedure. Some patients cannot have conscious sedation TAVR for a variety of reasons, most commonly because of the type of procedure required to insert the catheter. Other patients may not be able to lie supine comfortably. Some patients also prefer to be asleep during the procedure, and general anesthesia is used for them.

How has this procedure affected hospitalization and recovery times? Recovery times are much quicker with conscious sedation, as these patients remain fully awake. Fewer invasive arterial lines are required, and patients are dismissed from the procedure room directly to telemetry, bypassing the post-anesthesia care unit and the intensive care unit. Procedure setup time and room turnover has significantly decreased. These practice changes have led to significant savings in resources such as personnel, room utilization, and hospitalization costs. What special training and experience does the surgeon require? All physicians who perform TAVR undergo training programs specific to the therapy. There are a variety of TAVR valves in current use, and regular training is done to maintain proficiency in the nuances of these valves and their delivery systems. For performing TAVR with conscious sedation, it’s important that the physicians, surgeons included, continually interact with the patient to ensure patient comfort throughout the procedure. At multiple points, such as vascular access or valve deployment, the patient is verbally guided.

In the future, replacement of the mitral valve, which lies between the heart’s left atrium and left ventricle, could also be performed using conscious sedation. Mitral valve replacement is most commonly performed now with open surgery, but newer methods have been developed in the past several years. Last year, we were the first center in the U.S. to perform transcatheter mitral valve replacement (TMVR) without cardiopulmonary bypass in a patient with mitral regurgitation. This was a remarkable advance. The mitral valve prosthesis was placed through a surgical incision in the chest cavity, and there was complete elimination of the regurgitation. The TMVR procedure took less than 60 minutes even though the procedure was being performed for the first time. This therapy, like many others in valve disease, is evolving further, and I believe many other procedures besides TAVR will be performed with conscious sedation.

TAVR is a very safe procedure.

If there are complications during conscious sedation, is the patient switched to general anesthesia? All procedures are performed in hybrid operating rooms, where patients can be immediately placed under general anesthesia and receive the care they need to address any complications that arise. A multidisciplinary team has immediate access to tools for support, such as emergency cardiopulmonary bypass. Although the risk of TAVR has become low, complications can be catastrophic, and it’s important for the team to be fully prepared for these situations. Do you expect conscious sedation to become the standard approach to performing TAVRs? TAVR is a very safe procedure. The procedure can be completed in under 45 minutes, and the transfemoral route can be used in over 90 percent of patients. Given the safety of this procedure, patient preference for avoiding general anesthesia, and the increased procedural efficiency and potential for savings in resources, I believe that conscious sedation TAVR will become the standard of care. Most of all, I hope that this innovation will lead to more patients receiving the lifesaving care they deserve.

What does the future hold for conscious sedation? It’s very bright. We’ve seen a remarkable transformation in how valve therapy has evolved over the past several years. Not long ago, there were few options for patients with valve disease, and many of these patients could not or were unwilling to undergo a lifesaving procedure. Conscious sedation, with its ability to maximize the ease of recovery from our procedures, is a huge advancement for the thousands of patients afflicted with aortic stenosis in Minnesota.

Life.

And all the living that goes with it. We enhance the lives of our residents, care team, and communities — helping us all to live fully in environments of respect, imagination and collaboration.

How many conscious sedation procedures have been performed at the Minneapolis Heart Institute? While we have been doing TAVR with MAC for years, we began conscious sedation for these cases earlier this year. Thus far, 40 percent of our eligible patients have undergone TAVR with conscious sedation, and that number will rise sharply in 2016. What other surgical procedures would be appropriate for conscious sedation? Most interventional cardiology procedures, such as coronary stent placement or congenital therapies, are currently performed with conscious sedation. Some valve therapies are performed with conscious sedation. Otherwise, for surgical heart valve replacement, TAVR is the only procedure performed with conscious sedation.

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OR AL HEALTH

Dental disease A look at some common problems By Alan Law, DDS, PhD, and Lowell Reither, DDS

ost of us have been treated for dental caries (tooth decay and cavities) or periodontal (gum) disease at some point. If these common conditions are left untreated, bacteria can produce oral infections and abscesses, and the infection can spread to the bloodstream and other parts of the body, sometimes causing sepsis, tissue and organ damage, and chronic disease. Fortunately, stringent oral hygiene sharply reduces these risks.

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Infection sets in Bacterial infections in the mouth can produce abscesses in the teeth, gums, or oral cavity. As the body fights the infection, pus

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MINNESOTA HEALTH CARE NEWS JULY 2016

accumulates, producing swelling and, in many cases, intense pain due to increased pressure. Fortunately, the disease process in the mouth is often localized to a tooth or the adjacent gum and bone, but if the infection is not halted with antibiotics, root canals, or drainage, bacteria can spread to the neck or around the eye and can be carried along in the blood, resulting in more serious health conditions. The knowledge that bacterial infections in the mouth could spread to the rest of the body has been around since the mid-1800s. Unfortunately, a lack of understanding that oral infections are usually well-localized to the area immediately surrounding a tooth resulted in many dentists and physicians recommending extraction of all of a patient’s teeth to cure disease. After discovering that patient health did not improve in patients who had their teeth extracted, this practice was discredited. While it is sometimes necessary to remove individual teeth, complete extraction of all teeth as a means of treating systemic (body-wide) infection is no longer accepted as appropriate care. With the advent of modern microbiologic techniques, we now know that there are many non-harmful bacteria that reside in the human body, many of which can be beneficial. Any form of oral infection should be addressed, however, since it may represent a significant risk factor affecting overall health. Sepsis An infection anywhere in the body can spread to the blood stream, producing septicemia or sepsis, in which chemicals released by the body’s immune system produce an inflammatory response throughout the body, sometimes causing permanent damage to tissue or organs. Treatment for sepsis includes aggressive antibiotics and intravenous fluids, and, in some instances, surgical removal of damaged tissue. Sepsis often strikes quickly, with 1 million cases annually in the U.S. More than 258,000 patients die each year of sepsis, making it the ninth leading cause of disease-related deaths. While sepsis can originate from any wound or internal infection, the rapid onset and severe consequences underscore the need to address all oral infections, particularly in people with compromised immune systems. In some cases, dentists may recommend taking antibiotics prior to oral surgery or dental procedures. Systemic diseases Recent articles in both scientific journals and the popular press have linked dental disease to several health outcomes, including heart

disease, low-birth weight babies, stroke, and cancer. The mechanism by which an oral infection can have systemic consequences is not always clear, but is likely related directly to the spread of oral microbes or the systemic spread of inflammatory mediators (chemicals or molecules that the body uses to fight infections, which can also cause pain and swelling).

While uncommon, oral infections can also result in bacterial endocarditis, an infection of the heart valves or lining of the heart. It occurs most often in individuals with previously damaged heart valves or heart tissue, and rarely occurs in individuals with healthy hearts. This is why individuals with known damaged heart valves may be required to take antibiotics prior to dental procedures. However, it has also been reported that approximately 8 percent of cases have occurred in individuals with periodontal or dental disease who did not undergo a dental procedure. It is clear that the risk to patients remains until they improve their oral health.

Dental disease is preventable with proper oral hygiene.

It is tempting to conclude that diseases in the mouth cause diseases in other parts of the patient’s body, but it’s also important to note that patients with poor oral health may also have other habits related to poor systemic health. For example, patients who smoke are more likely to have periodontal disease, and are also more likely to have heart disease.

Most studies linking oral disease to systemic disease focus on periodontal disease. Caused mainly by bacteria, periodontal disease is a disease of the attachment between the tooth and supporting gingiva (“gum”) and bone tissue. Its progression can lead to bone loss and deep pockets around the teeth that leave less support for the teeth. Direct to the heart Periodontal disease may predispose people to cardiovascular disease. Much of the research in this area involves immune reactions to bacteria in the periodontal pockets that, in turn, can produce clots and damage to the heart’s blood vessels. Because the immune chemicals can travel in the blood stream, blood vessels in the heart may be more susceptible to damage from this nonspecific immune response.

Don’t Suffer Alone

Other health issues In rare instances, dental infections can cause more serious and life-threatening systemic disease and in some cases can result in decreased blood flow to major organs, causing severe damage or complete loss of function in one or more organs. If left untreated, dental disease may result in significant physical and financial consequences. Hospitalization may be necessary to administer intravenous antibiotics to fight systemic infections or, in some cases, an incision to drain the infection. According to one study, more than 400,000 emergency department visits during 2006 were primarily related to tooth pulp and periapical diseases. Total charges for these emergency department visits exceeded $160 Dental disease to page 34

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

PEDIATRICS

Chickenpox Less common, but still a concern By Vijay Chawla, MD, FFAP, and Nancy Ott, MD, FAAP, FAAAAI

f you are younger than 21, you may never have experienced the itchy red bumps, fever, and other symptoms of chickenpox. Widespread vaccinations introduced in 1995 have slashed rates of this once-common childhood disease, but the reduced rates of illnesses, hospitalizations, and deaths have also led many to discount

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MINNESOTA HEALTH CARE NEWS JULY 2016

the risks of chickenpox, which continues to strike people of all ages and can reemerge as shingles later in life. Striking all ages Chickenpox virus (varicella zoster virus, or VZV) causes two clinically distinct forms of the disease. An initial or primary infection causes chickenpox. Years later, latent viruses can reactivate to produce herpes zoster (shingles), the risk of which increases with advancing age. Humans are the only host of the chickenpox virus, and the disease is highly communicable, striking approximately 90 percent of people living in the same household as those afflicted. At first, chickenpox symptoms may seem like those of any other virus: fever, fatigue, muscle aches, loss of appetite, and headache. Within a day or two, however, itchy red bumps appear, together with an intense urge to scratch. Small blisters, or vesicles, then form on the red bumps. The bumps crop up on the face, chest, abdomen, and back, then spread elsewhere, possibly to the inside of the mouth, eyelids, and groin. Years ago, children would stay home from school and avoid friends for a week to prevent spreading the virus by air or by touch — a risk that began two days before symptoms emerged and lasted until all the spots were crusted over, generally after 5–7 days. A number of home remedies were often tried in vain to control the itch, including Calamine lotion, baking soda, or oatmeal baths. Diphenhydramine, the first antihistamine developed in the 1950s, would help the itch and make you sleep — but only offered relief for four hours. Acetaminophen reduced fever and achy muscles, but not as well as aspirin, which was the common pain and fever medication in the 1950s and 1960s. In the 1970s, physicians advised against using aspirin, because some children with viral illnesses, including chickenpox, developed Reye’s syndrome, a life-threatening condition that causes vomiting, headache, and sometimes coma. Current treatment for chickenpox still includes cool baths, sedating antihistamines such as diphenhydramine or hydroxyzine, and nonsedating antihistamines such as cetirizine for itch. Acetaminophen or ibuprofen can be used for fever control.

Before chickenpox vaccinations became common, many parents believed — and some still believe — that it would be “best” for their children to be exposed to others with chickenpox. Ask a parent from that era, and you may hear talk of “chickenpox parties” or “chickenpox lollipops,” intended to produce new cases and thereby create a natural immunity against the disease. This practice ignored the facts, however: chickenpox can present severe, potentially life-threatening complications for people of all ages, and poses particular risks for those with suppressed immune systems. Pregnant women are also at higher risk, and their babies may suffer from low birth weights and birth defects, including limb abnormalities.

dose is given between 7–12 years of age, the minimal interval between the two doses should be three months. If the first dose is given at the age of 13 and older, the minimum interval between the two doses can be as short as four weeks. Varicella vaccine can be given alone, or combined into a single immunization that also protects against measles, mumps, and rubella (MMR). Neither of these vaccine forms contain latex or egg protein, but they do contain gelatin and neomycin.

Latent chickenpox virus can be reactivated in the form of shingles.

The chickenpox virus remains in the system long after the patient recovers. Years or decades after the primary infection, the latent chickenpox virus can be reactivated in the form of shingles, characterized by a painful, blistering rash. The lifetime risk of shingles is approximately 32 percent, with 1 million cases annually in the U.S. Fortunately, there is a way to reduce risks associated with both chickenpox and shingles: vaccination. The picture changes In 1995, the U.S. became the first country in the world to implement a program for universal varicella vaccination. Before that time, the Centers for Disease Control (CDC) estimated 4 million annual cases in the U.S., with 11,000 hospitalizations and 100 deaths. The vaccine, which contained a milder, or attenuated, form of the live virus, was administered originally as a single dose; it led to an 84 percent reduction in chickenpox cases and an 88 percent reduction in hospitalizations.

Side effects are rare. A mild case occurs rarely up to a month after the vaccine. Fever and fever-related (febrile) seizures have been reported in a very small number of children between 12–23 months of age. Among those receiving a combined MMR and chickenpox vaccination, 7–9 seizures occurred per 10,000 children 5–12 days after the vaccine. Among those who received the MMR and chickenpox vaccines separately during the same visit, 3–4 febrile seizures occurred per 10,000 children. These seizures have not predisposed children to epilepsy or neurodevelopmental delays. Women of child-bearing age. Women who develop chickenpox during pregnancy may deliver babies with low birth weights and birth defects. If you plan to have children in the future and do receive the vaccine, avoid pregnancy for at least four weeks after Chickenpox to page 17

stdavidscenter.org 952.548.8700

Despite these improvements, breakthrough infections were reported as immunity produced by the single dose of varicella vaccine declined over time. This led to a two-dose schedule in 2006, which over 10 years of observation period has been demonstrated to be 98 percent effective in preventing primary chickenpox disease and 99 percent effective in preventing related severe disease. These programs also benefited adults who were not vaccinated. One study showed a 74 percent reduction in adults, despite the fact that only 3 percent of those older individuals had been vaccinated. The decline is attributed to “herd immunity”: the fewer patients that acquire chickenpox, the less risk of spreading it to others in the community. This is not an argument to avoid vaccination, though. The risks remain for all of those who have never had the vaccine or acquired chickenpox through natural exposure. Guidelines Some recommendations for patients of all ages and circumstances: Children. We recommend routine chickenpox immunizations for all children. The first dose is given between the ages of 12–15 months and a booster dose is given between the ages of 4–6 years. If a child misses the primary immunization with the two-dose series, the catch-up immunization should be done at any age. If the first

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Early Childhood Education • Autism Services Pediatric Speech, Music and Occupational Therapy Children’s Mental Health • Foster Care Services for Individuals with Lifelong Special Needs More than 2,400 families have found a place to belong at St. David’s Center. MAKE A REFERRAL. JULY 2016 MINNESOTA HEALTH CARE NEWS

Calendar July-August 2016 July 9

Multiple Myeloma Support Group

Park Nicollet offers this free monthly support group for individuals with myeloma, their family members, and friends. Come meet others living with multiple myeloma, from those who are newly diagnosed to survivors of more than 19 years. No registration required. For more information, call Pat at (952) 649-1377. Saturday, July 9, 10 a. m. – 12 p. m., Park Nicollet Frauenshuh Cancer Center, 3931 Louisiana Ave. S., St. Louis Park

Stroke Support Group

Regions Hospital hosts this free monthly support group for stroke survivors and their families and caregivers. Come gain information, support, and encouragement and share stories with others in a similar situation. No registration required. Call (651) 254-3200 for more information.

Wednesday, July 13, 4 – 5:30 p. m., Regions Hospital Rehabilitation Institute, 640 Jackson St., St. Paul

Sexual Health Workshop for Parents

The Family Partnership presents this free “It’s That Easy!” workshop for parents of 10- to 19-year-old girls and boys to empower them to connect with their children, share family values, and engage in meaningful conversations about sex, sexuality, and relationships. For more information or to RSVP, call Sarah at (612) 294 -2654.

Thursday, July 14, 6 – 7:30 p. m., The Family Partnership Community Room, 4123 E. Lake St., Minneapolis

Diabetes on a Budget

Fairview Health Services offers this class for anyone living with diabetes. Come learn how to eat healthy and manage your diabetes without breaking the bank. There is a cost of $5 to attend. For more information or to sign up, call (612) 672- 6700.

Thursday, July 21, 2 – 3:30 p. m., Fairview Clinics — Edina, 6545 France Ave. S., Ste. 150, Edina

Protecting Your Skin

t’s estimated that one in five Americans will develop skin cancer in their lifetime, making it the most common type of cancer in the U.S. The main cause is ultraviolet (UV) radiation from the sun. However, skin cancer is highly treatable when it is caught and treated early. The Skin Cancer Foundation recommends that everyone practice monthly head-to-toe self-examinations of their skin to find any new or changing lesions that might be cancerous or precancerous. Watch for moles that are asymmetrical, have border irregularity, have color variation, are more than 6 millimeters in diameter, or are changing in size, shape, or color. If you notice any areas of concern, see your dermatologist. To help prevent skin cancer, take steps such as avoiding sun exposure between 10 a. m. and 4 p. m., when the sun’s rays are most intense. Liberally apply broadspectrum, water-resistant sunscreen that protects against both UVA and UVB rays with an SPF of at least 30 on any parts of your skin that will not be covered by clothing, even on cloudy days. Reapply about every two hours or after swimming or sweating. Be extra cautious at pools or beaches as sand and water reflect and intensify the damaging rays of the sun, which can increase chances of sunburn. You can also wear light long sleeves and a wide-brimmed hat to reduce exposure.

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.

Aug. 4

Survivors of Suicide Support Group

The Bradshaw Celebration of Life Center hosts this monthly support group for anyone who has experienced the death of a loved one through suicide. Come connect with other individuals and families who understand. For more information, call (651) 407-8300. Thursday, Aug. 4, 7 – 8 p. m., Bradshaw Group, 4600 Greenhaven Dr., White Bear Lake

Fitness in the Park

Saint Paul Parks and Recreation offers this Yoga for the Body & Mind class as part of its free outdoor exercise program. Come do some light stretching and flexibility enhancing movements — perfect for those new to yoga or those suffering from chronic pain. No registration required; other dates are available. For more information, call (651) 280-0704. Thursday, Aug. 4, 9 – 10 a. m., Como Regional Park, 1199 Midway Pkwy., St. Paul

Lupus Lunch Discussion

The Lupus Foundation of Minnesota hosts this free discussion group for people living with lupus and other autoimmune diseases, as well as their family and friends. Lunch will be provided and experts will conduct an open discussion. To register, call Sandy at (952) 746 -5151. Thursday, Aug. 11, 12 – 1 p. m., Rondo Community Outreach Library, 461 Dale St. N., St. Paul

Busting Breast Cancer Myths Allina Health offers this free class for anyone who wants to learn more about breast cancer, its prevention, and its causes. A radiologist guest speaker will dispel myths, provide the facts, and answer questions about breast cancer and breast health. For more information or to reserve your spot, call (952) 925-4321. Thursday, Aug. 11, 5:30 – 7:30 p. m., CRAVE – Galleria of Edina, 3520 W. 70th St., Edina

America’s leading source of health information online 16

MINNESOTA HEALTH CARE NEWS JULY 2016

Chickenpox from page 15

completing immunization. If a woman is found to be non-immune during pregnancy, the vaccine should be given after delivery to complete the two-dose series. Immunosuppressed individuals. People with suppressed immune systems are likely to develop major complications from chickenpox and risk high rates of morbidity and mortality. Immunization of those with severe immunosuppression is challenging and should be undertaken with expert guidance and consultations. All members of a household with an immunosuppressed person should be vaccinated. Older adults. A separate shingles vaccine — 14 times more potent than the chickenpox vaccine — is recommend for people 60 years of age and older. Special circumstances and conditions. The chickenpox vaccine is not recommended for those who: • Have received high-dose steroids in the last 2 weeks • Have moderate to severe illness • Have any type of cancer • Have received blood products in the last 3 to 11 months • Are allergic to gelatin, neomycin, or other vaccine components • Have taken aspirin products

Conclusion Modern vaccines have drastically reduced rates of chickenpox, but the disease continues to pose serious health risks, particularly for unborn children and those with suppressed immune systems. Vaccines are extensively tested before release. Vaccine safety is monitored constantly. Vaccines are safe and severe adverse side effects are seen in less than one in a million.

Humans are the only host of the chickenpox virus.

Vijay Chawla, MD, FFAP, is assistant professor of pediatrics at the Mayo Clinic College of Medicine and a consultant in pediatric and adolescent medicine. She practices at the Mayo Clinic Health System in Albert Lea and Austin. Nancy Ott, MD, FAAP, FAAAAI, practices at Allergy and Asthma Specialists in Minneapolis and Southdale Allergy in Edina. Board-certified in pediatrics and allergy/immunology, she is also an adjunct assistant professor in pediatrics at the University of Minnesota.

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JULY 2016 MINNESOTA HEALTH CARE NEWS

2016 health care architecture

HONOR ROLL

innesota Physician Publishing’s 2016 Health Care Architecture Honor Roll recognizes 6 outstanding projects. This year’s Honor Roll projects include new or renovated clinics, emergency departments, surgery centers, and hospitals. The medical services range from routine clinic visits to specialized care. Populations served include the standard roster of patients seen at outpatient clinics and hospitals as well as specialized groups — such as children, adolescents, and mothers. Although the facilities differ in intended use and population served, they share a focus on providing a healing environment, efficient design and floor plans, and natural materials. Many projects incorporated the onstage/offstage operational model to separate patient areas from staff areas. A child psychiatric hospital worked to break down barriers between patients and staff through architectural design. Minnesota Physician Publishing thanks all those who participated in the 2016 Honor Roll.

MINNESOTA HEALTH CARE NEWS JULY 2016

Fairview Southdale Hospital Carl N. Platou Emergency Center Type of facility: Emergency department

Contractor: Knutson Construction Services

Location: Edina

Completion date: October 2015

Client: Fairview Health Services

Total cost: $35 million

Architect/Interior design: HGA Architects and Engineers

Square feet: 80,715

Engineer: HGA Architects and Engineers (civil); Dunham (mechanical, electrical, plumbing)

Facing page: Main entrance (top) and color-shift panels (bottom) Top: Waiting area

Allina Health Regina Hospital Emergency Department Type of facility: Emergency department Location: Hastings Client: Allina Health Architect/Interior design: HGA Architects and Engineers Engineer: HGA Architects and Engineers Contractor: Kraus-Anderson Construction Company Completion date: December 2015

he new Emergency Center at Fairview Southdale Hospital creates a strong public presence with the use of striking forms and materials. The sculptural screened glass feature wall provides privacy while admitting natural light into public spaces; at night, backlighting transforms the glass into a beacon visible to the community. The curved cantilevered second floor is clad in color-shift metal panels that change color with the viewing angle. To enhance the emergency department (ED) patient experience, the design incorporates an innovative on-

stage / offstage concept that separates patient areas from busy staff areas. The result is a calming and quiet patient zone, and a collaborative staff area. The Emergency Center has 43 treatment spaces including intake and urgent care rooms, a trauma room, two resuscitation rooms, and five behavioral health spaces. A new 18-bed observation unit on the second floor creates a quiet place for patients needing further observation, while increasing the efficiency of the ED. Modular exam and triage rooms can be opened or closed to accommodate changing needs.

egina Hospital’s new addition expanded their emergency services and imaging departments. The new emergency department was designed around an onstage/offstage operational model that separates patient care areas from care team and staff areas. This affords more privacy and centers the staff core in the middle of the department. Treatment rooms have two means of access; one from the staff core and the other from the semi-public corridor ringing the department. The addition includes a two-stall ambulance garage, two trauma bays, and eight treatment rooms. Two treatment rooms can be used as observation rooms if the need arises. The outpatient surgery entrance was relocated and connects into the main public circulation of the hospital, with wayfinding for patients and visitors inherent in the design. The renovated imaging department includes room for a new CT scanner and a dedicated MRI machine.

Total cost: $7.5 million (construction cost) Square feet: 16,170

Top right: Staff work core Bottom: Entrance JULY 2016 MINNESOTA HEALTH CARE NEWS

HEALTH CARE ARCHITECTURE Children’s Hospital St. Paul Type of facility: Hospital entrance building Location: St. Paul Client: Children’s Minnesota Architect/Interior design: HDR Engineer: Paulson & Clark Engineering Contractor: McGough Construction Completion date: May 2015 Total cost: $5 million Square feet: 3,000

or years, Children’s Hospital in St. Paul lacked an eye-catching main entrance, but the new iconic entry addition captures the imagination with sculptural ribbons that draw you in. A central garden complete with sculptures and stars makes you want to linger before entering the hospital. Abundant light shining through the two- story atrium along with bright-colored stars highlight the vibrant space and add a bit of dazzle when you arrive. It was important that the space feel whimsical and childlike

MINNESOTA HEALTH CARE NEWS JULY 2016

and not look imposing. At night, the entrance tower is a well-lit beacon that invites visitors in. A creative welcome center is strategically positioned at the intersection of the Children’s Patient Tower and the United Hospital Baby Center. Star patterns on the floor guide patients and visitors to the appropriate elevator and cutouts within the floor Top left: Main entrance create creative and Right: Entry interior intriguing scenes.

HONOR ROLL 2016 University of Minnesota Health Clinics and Surgery Center Type of facility: Clinic and outpatient surgery center

Contractor: McGough Construction

Location: Minneapolis

Completion date: February 2016

Client: University of Minnesota Health

Total cost: $165 million

Architect/Interior design: CannonDesign

The new state-of-the-art Clinics and Surgery Center houses 37 specialties and 10 outpatient operating rooms and has been designed so complementary clinics (such as ear, nose, and throat and audiology services) are adjacent to each other for the sake of convenience. Upon entering the building, patients are greeted by a concierge with a tablet who reviews appointment information with them and gives them a real-time location-monitoring badge. The badge lets the nurse find patients without calling their name out creating a personal care experience. Exam rooms feature photographs of Minnesota landscapes, designed to reduce patient anxiety. To bolster collaboration and research, private offices have been eliminated for providers and staff. Shared and open workspaces allow teams to discuss best practices for care delivery.

“Discovery bars” located on each floor let patients use tablets to search for clinical trials.

Square feet: 342,000

Top left: Lobby Bottom right: Building exterior

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

(651) 603-0720 • (800) 511-3696

HEALTH CARE ARCHITECTURE PrairieCare Child Psychiatric Hospital

Type of facility: Inpatient child and adolescent mental health hospital

(mechanical); Clark Engineering (civil/structural); Voson (plumbing)

Location: Brooklyn Park

Contractor: R.J. Ryan Construction, Inc.

Client: PrairieCare

Completion date: August 2015

Architect/Interior design: Pope Architects

Total cost: $24.5 million

Engineer: Egan Company (electrical); Legacy

Square feet: 72,588

Top: Lobby Bottom: Main entrance

MINNESOTA HEALTH CARE NEWS JULY 2016

n filling Minnesotaâ&#x20AC;&#x2122;s void of specialized psychiatric services for children and adolescents, PrairieCareâ&#x20AC;&#x2122;s vision was to transform psychiatric care through design. The new 50-bed Child Psychiatric Hospital offers a safe and supportive healing environment and breaks down barriers between patients and staff. The design goal was to create a highly secure setting that is non-institutional and tailored to its population. This was accomplished through non-obtrusive security features, innovative building materials, vibrant finishes, and access to nature. Blending wood and stone at the entry brings to mind a north woods destination and evokes a healing environment. Patient care stations, day rooms, and therapy spaces act as the heart of the building, connecting staff and patients and encouraging active healing. Fun colors and open doorways invite children in to play, explore, and become comfortable in their surroundings.

HONOR ROLL 2016 The Mother Baby Center at Mercy Hospital Type of facility: Birth center Location: Coon Rapids Client: Allina Health and Children’s Minnesota Architect/Interior design: HDR Engineer: Loucks; Dunham Contractor: Knutson Construction Services Completion date: July 2015

Top: Building exterior Middle: Entrance overhang Bottom: Corridor

Total cost: $28 million Square feet: 62,000

he Mother Baby Center at Mercy Hospital sits on the edge of the Mississippi River, so the owners and architects took inspiration from the river as the central theme of the addition. A color scheme was chosen that was fluid and soft, and textural elements such as stone and wood accentuated the theme. Photos of river images used in rooms and hallways encourage peace, tranquility, and healing. Iconic design elements from the first Mother

Baby Center in Minneapolis, such as super graphics, sculptural ribbons, lighting, and an iconic exterior are carried through the Mercy Hospital center as well. The new facility includes triage rooms, labor and delivery rooms, post-partum rooms, a special care nursery, and an operating room suite, which ensures that mothers receive state-of-the-art labor, delivery, and post-partum care.

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.

suRGical eXPeRtise

technoloGY

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Robot

weight loss surgery (bariatrics)

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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 2016 MINNESOTA HEALTH CARE NEWS

RHEUMATOLOGY

Sjögren’s syndrome An autoimmune condition By Umbreen Hasan, MD, FACR, FACP

ost of us experience dry eyes and dry mouths from time to time, but for more than 4 million Americans, these are not temporary annoyances, but the daily symptoms of Sjögren’s syndrome (SS), an autoimmune condition affecting tear and saliva production. For some patients, SS can also affect other parts of the body and lead to serious health concerns.

The body attacks itself Your immune system is designed to ward off attacks from antigens — foreign bodies such as viruses, bacteria, and pollen. With autoimmune conditions such as Sjögren’s (pronounced “SHOWgrins”), that process goes awry, attacking healthy cells and tissues.

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

• Trauma care • Food-borne illness • Chronic pain

MINNESOTA HEALTH CARE NEWS JULY 2016

These are generally lifelong, non-curable conditions, and may require care by a rheumatologist, a physician specializing in the diagnosis and treatment of musculoskeletal and systemic autoimmune conditions, including rheumatoid arthritis, lupus, scleroderma, gout, and Sjögren’s. First described by Swedish ophthalmologist Henrik Sjögren in 1933, SS is a chronic multisystem inflammatory disorder. Most patients — 70 percent — experience primary Sjögren’s, which is associated with decreased tear and saliva production. The rest experience secondary SS, which is associated with other conditions such as rheumatoid arthritis and lupus. While the exact cause of Sjögren’s syndrome is unknown, some researchers believe that genetics and exposure to certain strains of virus or bacteria are factors. SS has an annual incidence of 4 per 100,000 people in Minnesota. The national incidence is 7 per 100,000. Symptoms and diagnosis SS is a dysfunction of gland secretion that causes dry eyes and dry mouth, also known as sicca complex. It can also cause skin dryness, dry nasal passages, vaginal dryness, and, for some, body-wide or systemic complaints. Patients often report persistent dry eyes and/ or dry mouth, a sensation of gravel in the eyes, troublesome dry eyes for more then three months, a reliance on tear substitutes more then three times per day, unexplained increases in dental caries, interrupted sleep due to mouth dryness, frequent sips of liquid to aid with swallowing dry food, and recurrent swollen salivary glands as an adult. If you suspect that you have SS, visit your primary care physician. If they suspect the condition, you will be referred to a specialist. SS requires a team approach involving a rheumatologist; an ear, nose, and throat doctor (otolaryngologist); a dentist; and an ophthalmologist. To confirm the diagnosis, rheumatologists will first perform a thorough medical history and physical, focusing on the salivary glands, mouth, teeth, rashes on the lower legs (which could indicate inflammation of the blood vessels), neuropathies, and the presence of any arthritis. They will also order lab work, including complete cell counts, immunoglobulins, urine, inflammation markers, and antibodies, and may perform imaging of the salivary glands. The patient will also be referred to an ophthalmologist for evaluation and management of dry eyes.

Your rheumatologist will review your blood work to determine whether you have specific antibodies (antinuclear, rheumatoid, and anti Ro/La) associated with Sjögren’s. To confirm the diagnosis of primary Sjögren’s, patients should have positive levels of these antibodies and symptoms of sicca. If the blood tests are negative, then a salivary gland biopsy will be performed as a confirmatory test. This minor salivary gland biopsy — an outpatient procedure performed by an otolaryngologist or an oral surgeon — helps to confirm the diagnosis of SS and to exclude conditions that mimic Sjögren’s, such as hepatitis C, HIV, age-related oral/eye dryness, certain medications, and sarcoidosis. Under local anesthesia, biopsied tissue is removed through a small incision in the lower lip, then sent to a pathologist to check for inflammatory changes typically seen in SS. You will also be evaluated for other associated autoimmune systemic diseases, to determine whether you have primary or secondary SS. Treatment SS requires a multidisciplinary approach coordinated by a rheumatologist in collaboration with other clinicians. Symptom control may include:

effects such as excessive sweating, increased frequency of urination, flushing, chills, nausea, diarrhea, low blood pressure, and decreased heart rate. Strategies to relieve other dryness symptoms. Sjögren’s can also produce dryness in other parts of the body. For nasal dryness, use humidifiers and saline nasal sprays. Gentle nasal lavage can help with removing encrusted secretions. Women may experience vaginal dryness, which can increase the risk of yeast infections. Use topical moisturizer and lubricants and consider seeking a referral to a gynecologist for painful intercourse due to dryness. If you experience dry skin, use mild cleansers, apply skin moisturizers, and avoid excessive skin washing. Fragranced moisturizers should also be avoided. Use sunscreen for additional skin protection. For cracking and dry skin around the lips, apply frequent lip salves or petroleum jelly. Sjögren’s can also alter your sense of smell. Ask your physician to confirm that you do not have a coexisting zinc deficiency, which also affects smell and can be reversible.

SS is a chronic multisystem inflammatory disorder.

Preventive and non-pharmaceutical options for dry mouth and dry eyes. Your care team may recommend that you: • Avoid medications that can cause dry mouth, including muscle relaxants, sedatives, antihistamines, and diuretics.

Long-term complications SS can affect many different organ systems. Sjögren’s syndrome to page 32

• Run a humidifier. • Apply artificial preservative-free tears. Products with preservatives can cause eye irritation. • Use artificial saliva products to provide more viscosity and lubrication. Look for sprays, liquids, rinses, gels, and lozenges that contain carbocymethylcellulose and polyethylene glycol. • Stimulate saliva flow with lemon drops — sugarless, to prevent caries. Dried, non-sugared fruit slices such as peaches or nectarines can also stimulate saliva. • Visit your dental hygienist regularly, since Sjögren’s increases your risk of dental caries. Floss after every meal and use a fluoride toothpaste or mouth rinse. Make sure that your toothpaste does not contain sodium lauryl sulfate, which is an irritant. • Maintain good hydration and drink only sugar-free liquids. At the same time, note that excessive sipping of water can dry the mouth due to evaporation. If necessary, use artificial saliva to help coat mouth surfaces. • Avoid oral irritants such as coffee, alcohol, carbonated beverages, and nicotine. • Maintain open nasal passages to prevent mouth breathing. Prescription medications for dry mouth. If these conservative measures fail, your physician may prescribe sialogogues, which stimulate the natural secretion of saliva. These medications are used early in the course of SS, while the patient still has baseline salivary excretion that can be induced with stimulation. The two most common such medications are pilocarpine and cevimeline. These medicines do not help with dry eyes, and may produce adverse

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R ADIOLOGY

Lung cancer screening Are you a candidate? By Aaron Binstock, MD

ung cancer is the leading cause of cancer death for both men and women, not only in the United States, but worldwide. For 2016, the American Cancer Society estimates 224,390 new diagnoses of lung cancer in the U.S.—117,920 in men and 106,470 in women—and 158,080 deaths. Lung cancer accounts for 27 percent of all cancer-related deaths, with smoking by far the leading risk factor; approximately 80 percent of lung cancer deaths are thought to result from smoking. Over the last four decades there

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has been minimal reduction in lung cancer mortality from clinical interventions. At the time of diagnosis, lung cancer is often already at an advanced stage, with a five-year survival rate of approximately 17.4 percent. In light of these well-known risk factors, and the better prog nosis with increased survival when it is caught and treated early, screening high-risk individuals for lung cancer has been studied on multiple occasions, but without a clearly defined benefit. This was largely due to previous limitations in CT technology for radiation dose reduction and limitations of the chest X-ray (CXR) as a screening tool. The history of screening According to the American Cancer Society, lung cancer, along with colon, breast, and prostate, are the four leading global causes of cancer death for both men and women. Of these, lung cancer is the only one not subject to routine screening. Several studies have assessed ways to screen the at-risk population for lung cancer using various methods, including CXR, sputum analysis, and low-dose computed tomography (LDCT). Prior studies using CXR and sputum analysis at varying intervals of time were not successful in reducing lung cancer-specific mortality. This is largely because a CXR typically does not detect early cancer (stage 1 and 2). The majority of lung cancer detected with CXR is stage 3 and 4, which have dismal prognoses. With the advancement of imaging technology, LDCT has become more promising. The National Lung Screening Trial (NLST), a study of over 53,000 patients, found a reduction in lung cancer mortality in high-risk patients aged 55 to 74 after being screened with LDCT compared with CXR. These individuals were enrolled and randomly assigned to three annual screens with either LDCT or CXR. The persons enrolled were considered high risk if they had a 30 packyear history of cigarette smoking (a “pack-year” equals the number of packs smoked per day times the number of years as a smoker). Former smokers could also be enrolled, but they had to have quit in the past 15 years. The results showed a mortality reduction of 20 percent in patients screened with LDCT.

Since the release of the NLST results in 2011, at least 38 key stakeholder major medical societies and organizations have endorsed LDCT for the early detection of lung cancer. The U.S. Preventive Services Task Force (USPSTF), an independent panel of non-Federal experts in preventive and evidence-based medicine, has endorsed LDCT and recommends annual LDCT screening for people 55 to 80 years of age who have a >30 pack-year smoking history, and currently smoke, or have quit within the past 15 years. As a result of these recommendations, most people considered to be at high risk and who have insurance coverage, including Medicare, will be covered for screening with no copay. A screening program A successful lung cancer screening program requires a coordinated approach with multispecialty provider involvement. A provider order is recommended for the screening LDCT. After performing a risk assessment and confirming that the patient is a candidate for lung cancer screening based on the listed criteria, the most important component of a screening program begins with patient education.

to be treated for lung cancer if it is found. Part of the shared decision-making process should include counseling on smoking cessation or referral to a smoking cessation program. Once the patient verbalizes understanding, and has agreed to enter the program, the next step is the actual exam. CT examination information The exam is a low-dose CT that can be performed as an outpatient with no preparation, fasting, or IV contrast. The exam takes less than 10 minutes to complete and is performed with the lowest radiation dose possible to still detect pulmonary lesions. This is typically less than 25 percent of the dose for a traditional diagnostic chest CT. The patient will receive a radiation dose lower than the background radiation an individual Minnesotan is subjected to every year.

A single normal screening CT is not a green light to continue smoking.

Shared decision making Before agreeing to be screened, patients should be provided a thorough explanation of the benefits and risks of screening, diagnostic testing, over-diagnosis, the false-positive rate, and total radiation exposure. With any screening test, there is a risk of a false positive or false negative exam, which could lead to additional imaging or unnecessary procedures and associated risks. Although low, the risks are real and the patient needs to be informed and willing to proceed. These risks can also be mitigated by having the scans reviewed by a multidisciplinary program prior to any action. The overall goal of the lung cancer screening program is to monitor and catch cancer at the earliest possible stage. It is important that the patient understands the commitment to annual screening, similar to mammography. Furthermore, it must be clearly explained that a single normal screening CT is not a green light to continue smoking and forgo further annual screening, as this will not result in improved cancer detection or survival. Patient selection/screening criteria The ideal candidate for annual lung cancer screening using LDCT is: • Between the ages 55–80 (Medicare covers ages 55-77)

After the exam, a formal report of the findings will go to the ordering provider. Similar to mammography, structured reporting will be based on the ACR Lung Imaging Reporting and Data System (Lung-RADS), which results in a consistent style of reporting as well as specific criteria in nodule characterization and management recommendations. The ACR Lung cancer screening to page 31

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• A current smoker or quit within the last 15 years • A patient with a smoking history of 30 pack-years or more The patient must be free of symptoms, without active signs of lung cancer such as hemoptysis. An appropriate screening candidate also should not have a history of any cancer that has been treated in the last five years. Another very important part of patient selection is that the individual must be both medically able and willing JULY 2016 MINNESOTA HEALTH CARE NEWS

BEHAVIOR AL HEALTH

East African culture and mental health

Blending two worlds

By Ahmed M. Hassan, MA, LPCC

ast African culture has its own way of conceptualizing, expressing, and treating mental illness. African concepts are rooted in indigenous traditions as well as centuries-old influences of European and Middle Eastern religions. While Christianity and Islam discouraged indigenous cultural practices, many communities figured out ways to incorporate them.

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Other common beliefs include zar, the dominance of an evil spirit that makes certain demands of a person or his relatives, inflicting trouble if they are not fulfilled. Other disorders are caused by sihir, a fetish or charm devised by one person to intentionally cause harm to another or by the evil eye, brought on unintentionally. For example, excessive praise or attention can attract evil spirits to an infant or child, which accounts for the custom of shielding newborns from outsiders for the first four months of life. Both sihir and jinn come from Islam, but evil eye and zar originate in African traditional practices that predate Islam and Christianity. All of these beliefs presume that mental illness is rooted in the world of spirits rather than the brain and emotions. The flaw is not in the person but in the external force that occupies the person, and that force needs to be cast out.

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Waali translates as “crazy” or “mad.” Symptoms of waali include violent behavior, taking off clothes in public, and talking nonsense or talking to oneself. Members of the family and the community usually help the person seek treatment of waali. Jinn is a stigmatizing form of mental illness caused by a powerful being capable of exerting influence over human action and behavior. The symptoms include appearing unconscious, spirit possession (disassociation), being mentally unfit, being afraid, and going mad.

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Somali perceptions of mental illness Somalis express mental illnesses in several ways. Murug implies everyday sadness, stress, or depression and is associated with the migration process, financial stressors, experience in exile, and loss of family lives and property during the Somali civil war. Symptoms include flashbacks, headaches, loss of interest, loss of appetite, poor sleep, crying easily, and lack of social activity.

MINNESOTA HEALTH CARE NEWS JULY 2016

Somali perceptions of treatment In East Africa, mental illnesses are usually treated by both traditional African healers and religious healers. Western medicine — introduced by colonial powers — is also available, but is less accessible than it is here and is practiced differently. Western-style doctors in Africa do not educate patients or offer support systems such as nutritionists, nurses, and mental health practitioners.

Traditional African healers consist of herbalists, bonesetters, and traditional spiritual leaders. Religious healers include Koranic healers, who recite Koranic verses to the person, and Sufi healers, who, in addition to reciting the Koran, use spiritual transcendence mindfulness practices. Traditional and religious healings both focus on driving spirits away from the person or undoing the harm through ritual practices. In the case of zar, ritualized dancing is used to drive away spirits, while in jinn and other religious-based ailments, Koranic readings are standard. Healing is viewed as a struggle between an external healer (traditional or religious) and a bad agent (e.g., zar, jinn, sihir, and waali). In Africa, treatment by external healers galvanizes the family and community. If the patient cannot be rid of the condition and develops a longterm impairment, the family is expected to counterbalance the ill effects by caring for the person.

There is a widespread fear of being detained and hospitalized if one is diagnosed with mental illness. This fear comes from Somalis’ experience of “Westernized” treatment in Africa, where hospitalized patients are sometimes chained and drugged with no hope of recovery. There is a misunderstanding among Somalis about psychotropic medication, since some of them are familiar with antipsychotic medication and its side effects. They assume that every medication has similar side effects. Somalis may feel that their disorder is not severe enough to warrant treatment. Having survived horrific situations in the war and the camps, the discomfort of anxiety and depression seem relatively manageable. There is a mismatch between Somali and Western ideas about what defines mental illness and what is considered severe. Milder forms of mental illness that would be treated by professionals in the West are accepted in Africa and addressed within the family.

There is a mismatch between Somali and Western ideas about what defines mental illness.

Cultural considerations affecting the Somali population Pre-immigration stressors During the Somali civil war, citizens lived in a fight-or-flight mode. Often Somali men experienced torture, and Somali women experienced both torture and rape intended to terrorize them into submission. Many surviving Somalis, both adults and children, witnessed the murder or torture of family members and friends. As a result, many suffer from traumatic memories, flashback, depression, and anxiety. Effects of life in the refugee camps Many Westerners misunderstand life in a refugee camp, where people live in survival mode under constant threat of sexual violence and attacks from rival clans and hostile local populations. In addition to poor housing and shortages of water and food, a lack of employment in the camps leads to a sense of loss, low self-esteem, and helplessness. Refugees who settle in camps in other countries cannot leave the camp to seek employment or education or participate in any activities that require legal documents. Refugees are expected to stay in the camps until their country becomes peaceful or they are allowed to emigrate. By 2003, the average wait at Daadab, the largest camp in Kenya, was 17 years. Refugees suffer from depression, bipolar disorder, PTSD, schizophrenia, disassociation, and anxiety disorders. Resettlement in Western communities Once refugees emigrate to a third destination such as the U.S., they face stressors such as acculturation, poverty, lack of employment, and language barriers. Many Somalis struggle with the disintegration of their traditional social networks after losing family members and friends during the civil war, in the refugee camps, or in the resettlement process. The devastation resulting from this loss of social support cannot be overstated. Barriers to seeking help The Somali view of mental illnesses is very different from the views of Western health care providers. The belief that mental illness is caused by supernatural and spiritual possessions is as real to African refugees as empirical evidence and the scientific method are to Western society.

The Western approach is to help individuals learn strategies for healing themselves, but Somalis view a more passive role for themselves, believing that someone will heal them by expelling the force affecting them. Somalis may be unaccustomed to the idea that talking (psychotherapy) can remedy anything or that they can learn skills that will enable them to heal themselves. East African culture and mental health to page 30

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East African culture and mental health from page 29

Many refugees attribute their depression or anxiety to stress factors such as housing or employment, which seem more imperative than the deterioration of their mental health. They believe that if stressors are removed they will feel better, not knowing that the illness will still remain. Culturally responsive treatment Despite these cultural differences, many common U.S. behavioral health approaches can be effective if they are modified to reflect the values and beliefs that impact the day-to-day thinking, behaviors, and emotions of East African patients. Standard relaxation techniques could employ more familiar techniques used in the individual’s culture, and sessions could relate therapeutic interventions to familiar concepts and experiences. For example, explaining the connection between early childhood trauma and current symptoms encourages patients to talk about their past experiences, providing a sense of ownership of the treatment.

It is important for Somali individuals to understand what is at stake if mental illness is ignored. They have to address these conditions because the U.S. requires a different level of functioning than their country of origin did. One has to be fully functioning to do well here, unlike in refugee camps where people were more or less at the same level and there were no opportunities for advancement. In America, immigrants are expected, among other things, to learn a new language, negotiate an unfamiliar bureaucracy, and compete with native-born citizens. Understanding the beliefs and practices of the country of origin, recognizing and addressing the obstacles that prevent seeking treatment, and incorporating familiar cultural practices into therapy can encourage patients to accept mental health services more readily and lead to improved outcomes.

The belief that mental illness is caused by supernatural and spiritual possessions is … real to African refugees.

Ahmed M. Hassan, MA, LPCC, is a psychotherapist who directs Summit Guidance, with clinics in Saint Paul and Moorhead.

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Lung cancer screening from page 27

Lung-RADS should increase the cost-effectiveness of CT lung screening by secondarily decreasing the number of interval scans recommended and performed. The patient would also receive a letter reviewing the findings and recommendations. The patient should be entered into a database so they can be followed and contacted for the yearly screening exam, or before if there are abnormal findings. This information, including patient demographics and radiation dose of CT scan, would be uploaded to a national database coordinated through the ACR and Centers for Medicare & Medicaid Services (CMS). This data will be reviewed and assessed if the screening programs adhere to the guidelines, along with the impact it has on the diagnosis rate and stage of cancer.

The ultimate goal of the lung screening program is twofold. First, to detect cancer at an earlier and more treatable stage, resulting in a decrease in the mortality rate. Second, to educate and encourage smoking cessation, which over time will have an even greater impact on reducing lung cancer rates. Currently, the screening criteria may inadvertently exclude individuals who may be at increased risk for developing lung cancer. Examples include: persons younger or older than the listed criteria, people who quit smoking longer than 15 years ago, or have had exposure to other elements that increase their risk of developing lung cancer. LDCT lung cancer screening is still in its infancy and as the data is studied, we will likely see changes in the screening parameters and reporting to maximize the impact on those individuals at the greatest risk.

Lung cancer is the leading cause of cancer death for both men and women.

Summary Evidence-based medicine has demonstrated that low-dose CT screening can significantly reduce mortality and morbidity associated with lung cancer in high-risk patients. Lung cancer screening using LDCT within an organized program in the appropriate highrisk patient population should result in more benefit than harm.

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Aaron Binstock, MD, is director of oncology imaging at Suburban Imaging–North and past president of Suburban Radiologic Consultants– North Group. He is a board-certified radiologist subspecializing in body imaging. Dr. Binstock has been instrumental in shaping lung screening programs across the metro, as well as educating clinicians about CT lung cancer screening.

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Sjögren’s syndrome from page 25

Cutaneous vasculitis — an inflammation of the blood vessels of the skin that often produces a rash — is present in 10 percent of SS patients. Joint pain with non-deforming arthritis, mainly in the hands, wrists, and knees, affects 40 percent of SS patients. Rheumatoid factor, which is generally associated with rheumatoid arthritis, can be present in some patients, leading to a false positive test result for SS. Saliva serves as a buffer to stomach acid, a function that is hindered by the decreased saliva flow associated with SS. Its deficiency can also cause damage to the upper airways, resulting in chronic dry cough, hoarseness, throat clearing, and nasal crusting. Difficulty in swallowing is common due to decreased salivary flow.

Bone marrow involvement can cause low white cell count, anemia, and increased immunoglobulins. One of the most serious complications can be non-Hodgkin lymphoma. For those with SS, the risk is up to 44 times higher than for the general population. Most studies have revealed the average time frame of developing lymphoma is 6.5 – 7.5 years after the initial diagnosis of SS. Summing up Sjögren’s syndrome is a systemic autoimmune disease affecting the entire body. Most patients diagnosed with primary Sjögren’s experience a dry mouth and dry eyes due to a dysfunction in saliva and tear production. Secondary Sjögren’s is associated with these factors coupled with other autoimmune diseases such as rheumatoid arthritis and lupus. Patients may also experience joint pain, organ dysfunction, a heightened risk of non-Hodgkin lymphoma, and other serious conditions. While there is no cure, early diagnosis and referral to a care team that includes a rheumatologist can identify strategies to relieve symptoms.

SS requires a multidisciplinary approach coordinated by a rheumatologist.

Non-infectious inflammations of the bladder lining can result in painful and increased frequency of urination. This is 40 times higher in patients with SS. SS can also be associated with sensory neuropathy, producing a burning sensation in the lower extremities. Half of those diagnosed with SS report mood disorders, including depression.

Umbreen Hasan, MD, FACR, FACP, is director of rheumatology for North Memorial Health Care. She practices at Minnetonka Medical Center.

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

June 2016 Survey CO N S U M E R A S S O C I AT I O N

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. I am aware that there are both mental and physical elements of domestic violence. 80 80

60 60

2. I or a member of my family have been a victim of domestic violence. 35 35

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25 25

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3. I am aware of the resources available to victims of domestic violence.

30 30

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Strongly agree

Agree

No opinion

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Strongly disagree

4. I have spoken to members of my family about domestic violence.

Agree

No opinion

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Strongly disagree

5. I would be reluctant to report domestic violence.

35 35

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Strongly agree

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MINNESOTA HEALTH CARE NEWS JULY 2016

Strongly agree

Agree

No opinion

Disagree

Strongly agree

Agree

No opinion

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

40 40

20 20

Strongly disagree

Disagree

Strongly disagree

JOIN US.

Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community. Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.

www.mnhcca.org JULY 2016 MINNESOTA HEALTH CARE NEWS

Dental disease from page 13

million, and 5,721 of these patients were admitted for inpatient care. Preventable dental conditions of all types—from toothaches to oral infections and abscesses—represent a growing percentage of emergency department visits; one study showed a 16 percent increase in 2009 visits compared with visits in 2006. That trend may continue, as growing numbers of people face reductions in private dental insurance and Medicaid coverage, turning to the emergency department only when their needs become more dire. Because dental disease is preventable with proper oral hygiene and regular dental visits, most, if not all, of these hospitalizations and emergency room visits could have been prevented. Although it is extremely uncommon, untreated dental disease can also spread to the brain. In 2007, a 12-year-old Maryland boy, Deamonte Driver, died after bacteria from an abscessed tooth spread to his brain. This particular case drew considerable public attention, with politicians emphasizing the need to provide dental care to younger patients. The Deamonte Driver Project was formed to provide dental care for underserved children, in an effort to prevent similar tragedies.

Conclusion Because dental disease is preventable and untreated dental disease can lead to potentially serious health conditions—even death—it is important to practice good oral hygiene and have regular dental check-ups. It is also important to recognize signs of dental disease, which include pain when chewing, sensitivity to heat or cold, bitter taste in the mouth, breath odor, swollen glands of the neck, or a swollen area of the upper or lower jaw, the last of which can be a very serious symptom. Individuals experiencing any of these symptoms should visit a dentist to avoid the potential of a serious dental infection. Most dental infections can be treated with local treatment, such as a restoration (fillings or crowns), root canal treatment, deep cleaning of the gum tissue around the teeth, or extraction. In some cases, antibiotics may be necessary as an adjunct to manage the infection. As with all disease processes, routine hygiene, a healthy diet, and early diagnosis can prevent most complications.

Untreated dental disease can lead to potentially serious health conditions.

Alan Law, DDS, PhD, an endodontist and Diplomate with the American Board of Endodontics, practices with The Dental Specialists. Lowell Reither, DDS, is a general dentist practicing at Park Dental Brookpark.

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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

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MINNESOTA HEALTH CARE NEWS JULY 2016

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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].

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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