Minnesota Health care News September 2014 by Minnesota Physician Publishing

September 2014 â&#x20AC;˘ Volume 12 Number 9

Birthing options Katy Kozhimannil, PhD, MPA

Oral health and diabetes Sheila Strock, DMD, MPH

Painkiller addiction Pamela Shultz, MD

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September 2014 • Volume 12 Number 9

4 7 8 10 12 14

News

People

Perspective Elaine Cunningham Children’s Defense FundMinnesota

10 QUESTIONS Amber Lage Minneapolis Fire Department

Women’s Health Planning a birth?

By Katy B. Kozhimannil, PhD, MPA

Insurance

Medicare changes in 2015 By Stephanie Minor, MPP

16 18

Behavioral health

MINNESOTA HEALTH CARE ROUNDTABLE

Painkiller addiction By Pamela Shultz, MD

Calendar

Special focus: Diabetes

20 22 24 26 28

42nd Session

Managing diabetes By Munir Abid, MD

Diabetes and eye health

By Matthew Bauer, OD

Diabetes and oral health

By S heila Strock, DMD, MPH

Dermatology Tattoos

By Neil A. Shah, MD, FAAD

Research

Parkinson’s disease By Okeanis Vaou, MD

Background and focus: As tools and techniques for treating chronic illness have expanded, so have methods and mechanisms of provider reimbursement. More people now have access to care, and with this comes a heightened awareness of the impact of social determinants on health. The transition to rewarding physicians for maintaining a healthier population is slow but the promise is clear. Treating chronic illness remains an area of high-volume use and, improperly managed, quickly becomes an area of high cost. Objectives: We will evaluate changes that health care reform is bringing to chronic illness care. We will examine new community-based partnerships that are forming to address prevention, compliance, and better identification of risk. We will look at specific diseases and how workplace solutions, insurance companies, clinics, hospitals, long-term care facilities, and home care providers are working together to lower costs and improve outcomes.

Panelists include: • Kari Benson, MPA, Minnesota Board on Aging • Durand Burns, MD, Minneapolis Heart Institute Foundation • L. Read Sulik, MD, PrairieCare Publisher Mike Starnes | mstarnes@mppub.com Senior Editor Janet Cass | jcass@mppub.com Editor Lisa McGowan | lmcgowan@mppub.com Art Director Alice Savitski | asavitski@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com

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News

Drop in Adolescents’ Antidepressant Use Had Negative Effects

A study from the University of Minnesota School of Public Health, in collaboration with Dartmouth College and Yale University researchers, has found that 2003–2004 U.S. Food and Drug Administration (FDA) warning labels on antidepressants, which reduced antidepressant use among adolescents, also had negative effects on the students’ grade point averages, substance use, and delinquent behaviors. “Most evidence on depression treatment focuses on depression symptoms, but not the broader consequences of depression for academic performance and behavioral outcomes like substance use or delinquency,” said Ezra Golberstein, PhD, an author of the study and assistant professor of health policy and management at the University of Minnesota School of Public Health.

Researchers aimed to gain a broader view of the effects of treating adolescents with depression using antidepressant medications. They analyzed the grades, substance use, and delinquency rates for more than 100,000 adolescents through national surveys administered both before and after the FDA warnings went into effect, which led to a dramatic decline in antidepressant use in children and adolescents with depression. According to the study, after the FDA warnings were issued, other treatments such as psychotherapy stayed at similar levels, indicating that alternate treatments did not offset the drop in medication use. Researchers say this means many children and adolescents with depression are not receiving any form of treatment and that efforts to improve access to mental health care could yield great benefits beyond the clinical outcomes normally measured. “We found adolescents who sought treatment for depression after the FDA warnings had poorer

Minnesota Health care news September 2014

grades, more use of tobacco and illicit drugs, and more delinquency after a clinic visit, compared to adolescents seeking treatment for depression prior to the warnings,” said Ellen Meara, PhD, an author of the study and associate professor of health policy and clinical practice at the Geisel School of Medicine at Dartmouth. The authors noted that the study “does not favor one form of depression treatment over another.” Golberstein said the findings “tell us that treating adolescents who have depression problems can help mitigate the effects of a disease that has lifelong consequences.”

Study Projects Physician Shortage In Minnesota Results from a new study show that a shortage of primary care physicians will unfold over the next decade. The Minnesota Hospital Asso-

ciation (MHA) asked Towers Watson, a global professional services firm specializing in risk management and human resource consulting, to conduct an in-depth study of the status of primary care physician and registered nurse (RN) workforces in Minnesota. The company analyzed data from the national Bureau of Labor Statistics, the state of Minnesota, and workforce data that MHA compiled from Minnesota hospitals. “The current pipeline of graduates barely appears adequate to replace retirements as they occur,” the study reports. “That, coupled with projected increases in demand because of an aging population, will result in a significant talent gap for physicians.” The study projects a cumulative shortfall of nearly 850 primary care physicians in Minnesota by 2024 due to a lack of annual growth in Minnesota’s graduate medical education programs, including residency or clinical training positions. “Many of our hospitals, especially those in greater Minnesota,

already have difficulty attracting physicians,” said Lawrence Massa, president and CEO of MHA. “I hope this new information will provide an impetus to policymakers to make the urgent decisions needed on both the state and federal levels to give our health professional students access to the clinical training and residency experience they need to become licensed to practice.” According to the study, there likely will not be a gap in the RN workforce, as long as RN education programs continue to grow at expected rates. Nationally, the study noted that an aging population, slow graduate growth, increasing rates of retirement, and a growing population are “driving an impending talent shortage in the health care industry on a national level.”

MDH Hires Medical Cannabis Director The Minnesota Department of Health (MDH) has announced the appointment of Michelle Larson, MPA, as director of the new Office of Medical Cannabis, where she will oversee the state’s new medical cannabis program. Larson assumed her new position on Aug. 13. Most recently, Larson served as deputy director of the MDH Office of Statewide Health Improvement, where she managed high-profile health promotion programs to address tobacco use, obesity, and nutrition. She earned a master’s degree in public affairs from the University of Minnesota and is currently working toward a doctorate in organizational leadership and policy development. “This position requires a skilled administrator, but it also requires someone who can work with people from a range of backgrounds,” said Minnesota Commissioner of Health Ed Ehlinger, MD. “Michelle brings a strong background in public policy and administration, as well as a history of working with the public health community, law enforcement and security, pharmacists, health care providers, and community members. She has the ability to work with people to get things done right.”

Allina Adds Penny George Institute in Plymouth Allina has announced that the Penny George Institute for Health and Healing is opening a holistic medicine clinic at Abbott Northwestern–WestHealth in Plymouth. The new $1.2 million clinic is 3,500 square feet. Patients will be able to make appointments for health coaching, nutrition counseling, exercise and fitness consultations, tobacco cessation, and acupuncture. Stress and weight management classes will be offered as well. “We approach health and wellness from a mind, body, and spirit perspective,” said Courtney Baechler, MD, medical director of Penny George Institute for Health and Healing. “Often, people consult with us in addition to working with their primary doctors.”

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Regions Hospital Adds Veteran Mental Health Program Regions Hospital has announced the launch of its mental health program for military veterans who have psychological issues related to their military service. Current and former military service members can access the Lee and Penny Anderson HeroCare for Veterans program during inpatient hospitalization or partial hospitalization. The Veterans Administration and U.S. military will coordinate care services with the program to help address the high suicide rate among veterans. Twenty-two percent of suicides in the U.S. in 2010 were military veterans, according to the Veterans Administration. The organization also notes that the most common mental illnesses among veterans are post-traumatic stress disorder (PTSD), depression, and substance abuse disorders. “HeroCare comes at a time when there is a growing need for mental health services for our veterans,” said Chris Boese, vice president of patient care services at

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News to page 6 September 2014 Minnesota Health care news

News from page 5

Regions. “In 2012, more veterans died from suicide than combat. As the largest provider of mental health care in the east metro, we want to support those who fought for us in their time of need.” Those who utilize the program will have access to a specialist who is a military veteran with an expertise in navigating military benefits. The specialist will help veterans with financial, housing, and employment needs. The program includes therapies to help manage the unique symptoms and challenges that veterans with mental health issues face. Specifically, sensory integration is used to help reduce stress and anxiety and improve sleep patterns for those suffering from PTSD. “HeroCare will allow us to better treat our veterans by offering a camaraderie that other treatment environments cannot offer,” said John Kuzma, MD, medical director for inpatient mental health at Regions Hospital, and a veteran and former army psychiatrist. “Many

veterans are uncomfortable with others who cannot relate. That is why our care team and group sessions are composed of fellow service members.”

Mayo Ranks No. 1 Nationally in Report Mayo Clinic is the top hospital in Minnesota and, for the first time, in the country, according to results from U.S. News & World Report’s annual top hospital ranking. Nationally, Mayo Clinic earned the top ranking in eight of the 16 specialty categories measured: diabetes and endocrinology; ear, nose, and throat; gastroenterology and GI surgery; geriatrics; gynecology; nephrology; neurology and neurosurgery; and pulmonology. In addition, it ranked second or third in four categories. Mayo Clinic is the only Minnesota hospital to rank in the top three in any category nationally. Massachusetts General Hospital in Boston and Johns Hopkins Hos-

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

Minnesota Health care news September 2014

pital in Baltimore ranked second and third in the U.S. Within Minnesota, Abbott Northwestern Hospital and Mercy Hospital ranked as the second and third top hospitals. And within the Minneapolis–St. Paul metropolitan area, Abbott ranked first, with Mercy Hospital and the University of Minnesota Medical Center in second and third place, respectively. Overall, 144 U.S. hospitals ranked in at least one specialty category out of almost 5,000 medical centers that were evaluated. “Central to understanding the rankings is that they were developed and the specialties chosen to help consumers determine which hospitals provide the best care for the most serious or complicated medical conditions and procedures—pancreatic cancer, for example, or replacement of a heart valve in an elderly patient with comorbidities,” the authors of the report wrote. “Medical centers that excel in relatively commonplace conditions and procedures, such as noninvasive breast cancer or

uncomplicated knee replacement, are not the focus.”

Fairview Acquires Independent Gynecology Practice Fairview Health Services announced that it has purchased Edina-based Minnesota Gynecology and Surgery. Details of the terms have not been divulged. The specialty practice, which is located almost a mile and a half from Fairview Southdale Hospital, is now called Minnesota Gynecology and Surgery–Fairview. It will house three doctors, including Edward Beadle, MD, and James Presthus, MD, as well as a nurse practitioner. “From our first meeting with Drs. Beadle and Presthus, it was clear they have built a very successful practice based on quality and the patient experience,” Mark Domalewski, vice president of operations for Fairview Clinics, said in a statement.

People

Krisa Christian, MD

Krisa Christian, MD, board-certified in internal medicine, has joined the hospitalist department at Essentia Health–St. Mary’s Medical Center, Duluth. She graduated from the University of Minnesota Medical School and completed a residency in internal medicine at Hennepin County Medical Center (HCMC), Minneapolis. William Allen, MD, board-certified in internal

medicine, has joined HCMC’s internal medicine department. He graduated from the University of Minnesota Medical School and completed an internal medicine residency at HCMC. Joining HCMC family medicine staff is Subhadra Chereddy, MD, board-certified in family medicine. She graduated from Guntur MediWilliam Allen, cal College, India, and completed a MD family medicine residency at the UniSubhadra versity of Minnesota, North Memorial Family MediChereddy, MD cine Residency Program. Also joining HCMC family medicine staff is Sandra Lewis, MD, board-certified in family medicine. She graduated from the University of Minnesota Medical School and served a family medicine residency at HCMC, as did new HCMC family medicine staff member Bryan Nelson, MD, board-certified in family medicine.

Charles Fazio, MD, MS, has joined HealthPartBryan Nelson, ners as its health plan medical director. PreviMD ously, Fazio served as senior vice president and chief medical officer at Medica, and in clinical and administrative leadership roles at Mille Lacs Health System, St. Joseph’s Medical Center, Central Minnesota Group Health Plan, and the Institute for Clinical Systems Improvement. Fazio earned his medical degree from Georgetown University, Washington, DC, and his master’s in administrative medicine from the University of Wisconsin–Madison.

Timothy J. Wilt, MD, MPH, board-certified in internal medicine, has received the 2014 VA Undersecretary’s Award for Outstanding Achievement in Health Services Research. A staff physician in general medicine at the Minneapolis VA Medical Center and a professor of medicine at the University of Minnesota Medical School, Wilt’s research has led to the developTimothy Wilt, ment of national practice guidelines for implementing MD, MPH high-value, cost-conscious health care, especially in the area of screening. He earned a medical degree from the University of Illinois School of Medicine–Chicago and completed an internal medicine residency at the University of Minnesota, where he also earned a master’s degree in public health.

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Jessica Downes, MD, and Erik J. Peterson, MD, joined St. Croix Orthopaedics in August. Downes, board-eligible in orthopedic surgery, graduated from Creighton University School of Medicine, Omaha; served an orthopedic surgery residency at the University of Minnesota; and completed a foot and ankle fellowship at the University of Alabama, Birmingham. Peterson, board-certified in orthopedic surgery, graduated from The Medical College of Wisconsin, Madison, and served a residency in orthopedic surgery at the University of Minnesota.

September 2014 Minnesota Health care news

Perspective

Bridge to Benefits Helping families help themselves

t’s long been recognized that low-paying jobs do not provide enough to meet even the most austere budget. To help low-income working families meet basic needs, work-support programs such as Medicaid and Supplemental Nutrition Assistance Program (SNAP) were created. These programs can improve the economic stability of low-income households, often making the difference between accumulating debt and breaking even each month. Research clearly shows that such programs improve a family’s social, health, and educational outcomes.

Elaine Cunningham Children’s Defense Fund–MN Ms. Cunningham directs B2B at Children’s Defense Fund–MN, established in 1985 as one of 12 state and regional offices of the national Children’s Defense Fund (CDF). CDF’s mission is to ensure every child has the chance to successfully transition to adulthood with the help of caring families and communities. Its focus is on improving opportunities for all children to access health care, obtain quality education, achieve economic stability, have quality child care and early childhood experiences, and grow up in safe communities. CDFMN believes that early investments in youth improve outcomes, especially for those facing obstacles such as racism, poverty, and disability.

Families are not the only ones to benefit. These programs also boost local economies, because low-income families spend their dollars in their communities. Despite this win-win for families and communities that work-support programs offer, many Minnesota families are not enrolled in programs for which they are eligible.

How it began

In 2007, the Children’s Defense Fund-Minnesota (CDF-MN) launched Bridge to Benefits (B2B) to improve low-income families’ economic stability by connecting them to public work-support programs and tax credits. Programs include Medical Assistance, MinnesotaCare, Advanced Premium Tax Credits, SNAP, WIC, the School Meal Program, Child Care Assistance, Energy Assistance, Earned Income Tax Credit, and Working Family Tax Credit.

Overcoming barriers Reasons eligible families don’t enroll in these programs include complicated applications and enrollment processes. Literacy, language, and stigma often present barriers, too. Some families enroll in one or two programs, but rarely in all those for which they are eligible. This is unfortunate, because it is the cumulative effect of the programs that has the greatest impact on economic stability.

Minnesota Health care news September 2014

Growth Since 2007, more than 160,000 families have been screened via B2B. The project has grown tremendously, from 5,713 screens completed in 2008 to more than 52,316 screens in 2013. Nearly half the families screened in 2013 were eligible for help. More than 300 organizations statewide currently use B2B to screen the clients they serve.

Many Minnesota families are not enrolled in programs for which they are eligible.

B2B addresses many of these barriers by offering a one-stop shop for public programs. Its website includes information on programs and how to apply. It also provides quick online screening. By answering several screening questions about family size and income, families can find out whether they are potentially eligible for any of these programs, which often encourages them to apply. As an incentive, the online screening calculates the family’s potential benefit amount for each program.

Although any family can use B2B’s website, CDF-MN finds this tool is more effective when used by community organizations from which low-income families already seek help. CDF-MN recruits food shelves and other nonprofit organizations to use B2B to screen the families they serve. An email referral process built into the screening tool connects families who need assistance completing the application process to organizations providing one-on-one enrollment assistance. These organizations follow up with the families to make sure they enroll.

B2B’s website is constantly updated to reflect program changes and improve user friendliness. In 2014, the site underwent major revisions to incorporate eligibility standards and information for health care programs, as required under the Affordable Care Act. Feedback on B2B from families, organizations, and state and county administrators is overwhelmingly positive. The Minnesota Department of Human Services uses B2B as the screening tool for its online combined application for several state programs, including SNAP and Child Care Assistance. In addition to counties linking to B2B from their websites, health care navigators used it to screen for health care program eligibility as part of helping people sign up through MNsure, the state’s health insurance exchange.

The future Currently, about 65 percent of B2B screening activity occurs in the seven-county metro area, where most of this program’s 300 partners are located. Future plans include recruiting additional organizations in Greater Minnesota to use B2B with their clients, in order to increase awareness of this tool among the general public. While most people find out about the website through local, community-based organizations, B2B is a website anyone can use (mn.bridgetobenefits.org).

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10 Q u e s t i o n s

Who are you going to call ... 911? Amber Lage Ms. Lage is EMS training officer for the Minneapolis Fire Department.

When someone calls 911 for a medical emergency, why does a fire truck often arrive first? There are more fire apparatus in service than there are ambulances. The Minneapolis Fire Department has 19 fire stations located throughout the City of Minneapolis, and staffs 27 fire trucks with firefighters that are trained emergency medical technicians (EMTs). Consequently, 80 percent of the time we are able to respond to EMS calls in less than five minutes, which is typically much faster than an ambulance can arrive. This allows us to provide early, life-saving interventions until an ambulance arrives. Once the ambulance arrives, the paramedics can start advanced care and transport the patient to the most appropriate hospital. Which emergency medical skills are required for fire fighters to be first responders? Every Minneapolis firefighter is an emergency medical technician, certified by the National Registry of Emergency Medical Technicians and the Minnesota Emergency Medical Services Registry Board. We are able to assess and appropriately treat conditions ranging from simple fractures, stroke, and chest pain to critical trauma, cardiac arrest, and childbirth. We are continuously training to keep our skills current and to stay up to date with new medical procedures and equipment. Please tell us how emergency medical services are billed. If a fire truck and ambulance arrive at the same, does the patient receive a bill from each? No, in that scenario the patient would not receive a bill from each. The only service that the Minneapolis Fire Department bills for is extrication provided as a result of a motor vehicle accident. What are the most common medical emergencies that firefighters encounter? The Minneapolis Fire Department responds to a variety of medical emergencies every day. However, the medical emergencies we see most frequently are people in respiratory distress, those who are experiencing chest pain, or those who have experienced a traumatic injury. Besides being trained to respond to structure fires and medical emergencies, Minneapolis firefighters also are trained to respond to emergencies on lakes and rivers, technical and hazardous materials crises, and natural disasters citywide. How does a fire crew handle a medical emergency involving people who do not speak English? Minneapolis is very demographically diverse, so it is not uncommon for us to respond to someone who does not speak English. We are fortunate to have several different resources to rely on when this challenge arises. Frequently, there is a family member or friend on the scene who will interpret for us. Or, if time allows, we can access the City of Minneapolis Language Line, which provides interpreters fluent in Spanish, Somali, Hmong, and American Sign Language. Also, we have a number of employees who speak more than one language. What kind of seasonal variation in medical emergencies do you encounter? As you would expect, we see more heat-related emergencies in the summer, such as heat exhaustion or heat stroke. Unfortunately, along with the warmer weather comes an increase in drowning. During the winter months we typically see more hypothermia, frostbite, and traumatic injuries. These traumatic injuries are caused primarily by falls and motor vehicle accidents due to the snow and ice. We also see the highest threat of carbon monoxide (CO) poisonings in the winter months. CO is produced by faulty or poorly maintained appliances such as furnaces, boilers, water heaters, and gas heaters and dryers. Dirty or poorly repaired wood fireplaces, chimney flues, and gas space heaters also can produce CO, especially if ventilation is not adequate. Because CO is an odorless, colorless, and tasteless gas, it can kill you before you are aware it is in your home. The initial symptoms of carbon monoxide poisoning are headache, lightheadedness, dizziness, and unexplained sleepiness. The Minneapolis Fire Department stresses the importance of

having working smoke and carbon monoxide detectors in your home, and testing them regularly to ensure they are in working order. What can you tell us about domestic violence as a cause of emergency medical response? Sadly, this is not an uncommon call for us to respond to. In these circumstances, the Minneapolis Police Department also is dispatched to the scene. The police officers assist in making the scene safe both for the victim and for us to treat the victim.

car seat clinics at our fire stations. We do not provide clinics, nor are we able to confirm if car seats are properly installed. However, we encourage people to contact the Minnesota Department of Public Safety for more information (dps.mn.gov, (651) 215-1328/TTYL: (651) 282-6555). The most frequent type of fire-related death is caused by falling asleep with a lit cigarette. Most people do not realize that the end of a lit cigarette is 800 degrees Fahrenheit. When those burning embers fall on a bed, couch, or carpet, they can smolder, producing CO. When the person sleeping inhales the CO it causes them to become unconscious, making it impossible to hear a smoke detector or to evacuate.

Eighty percent of the time we are able to respond to EMS calls in less than five minutes.

What can you tell us about the annual volume of emergency medical calls the fire department receives, and the percentage of total calls to the department this represents? In 2013, the Minneapolis Fire Department responded to 38,133 total calls for service. This included fires, emergency medical service and rescue, false alarms, hazardous conditions, and other miscellaneous incidents. Of these calls, 25,815 were for rescue and emergency medical service, which constituted 68 percent of total call volume for the department.

What are the most common preventable medical emergencies that you see? We see many injuries and deaths from motor vehicle accidents each year. Surprisingly, there are still people who choose not to wear their seatbelts or do not have their children buckled in correctly. According to the Minnesota Department of Public Safety, three out of four child seats in Minnesota are used incorrectly, and many parents arenâ&#x20AC;&#x2122;t aware of the restraint steps a child should progress through as they age and grow. The Minneapolis Fire Department receives many phone calls each year asking if we provide

What does the future hold for firefighters and their role as medical first responders? The fire service is an ever-evolving field of emergency response. It will adjust to the medical needs of those we serve as they arise, as it has in other technical and specialty areas of response. One medical device that the Minneapolis Fire Department has begun using recently is the LUCAS Chest Compression System. The LUCAS is an electrically powered device that provides mechanical chest compressions of consistent quality. When we respond to someone having a sudden cardiac arrest, we may need to spend more than 30 minutes performing manual chest compressions during cardiopulmonary resuscitation (CPR). Maintaining high-quality chest compressions for that length of time is both difficult and tiring. This device is carried on HCMC ambulances and is used by fire department first responders, thereby freeing paramedics on the scene to focus on other life-saving tasks that may be necessary.

September 2014 Minnesota Health care news

W o m e n ’ s h e a lt h

Planning a birth? A look at some options By Katy B. Kozhimannil, PhD, MPA

any Minnesota women, myself included, may have birth stories that are very different from those their mothers tell, and the same might be said about their grandmothers. Those differences reflect today’s expanded options that include being attended by a professional who is not a physician and giving birth in a non-hospital setting, options that have been made easier to access by recent changes at the state level. One such change, for example, allows state health insurance programs to offer

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Minnesota Health care news September 2014

coverage for support from a professional childbirth support person called a doula. Another is state approval of nontraditional birth sites. Here’s a sampling of birth trends in the state and what women should keep in mind when deciding how they want to give birth. Historical trends Good trend 69,160 babies were born in Minnesota in 2013, and we should be proud of our track record of healthy births in the state. Rates of preterm birth (9.8 percent) and cesarean delivery (26.9 percent) are lower in Minnesota than the national averages (11.4 percent and 32.7 percent, respectively). Additionally, 73.5 percent of Minnesota mothers breastfeed their babies. National public health goals established by the Center for Disease Control and Prevention’s “Healthy People 2020” initiative aim to increase breastfeeding to 81.9 percent of babies, and to decrease rates of preterm birth and cesarean delivery, by 2020. Undesirable trend However, Minnesota’s overall progress toward these goals masks a challenge, which is that some of our low-income families, rural residents, and people of color experience worse pre- and postbirth outcomes than their higher-income, urban, and Caucasian counterparts. This is especially true for African Americans and Native Americans: African American and Native American babies are twice as likely to die in their first year of life as other babies. This disparity in infant mortality has not improved over the past 20 years, although the Minnesota Department of Health (MDH) and community organizations are working to reduce it. Some of the state’s efforts to increase access to new birth options may help address disparities in birth outcomes in Minnesota. Rural women and Native Americans face some of the state’s greatest barriers to access, a phenomenon described as “inadequate obstetric coverage,” according to a November 2013 report by the MDH. This report suggests that women would benefit from access to medical care from a range of providers, including nurse-midwives and family physicians, and also from access to support provided by trained childbirth professionals such as doulas, who provide educa-

tional and emotional support but not medical care. The report also suggests that rural hospital staff would benefit from greater access to cultural competency training. Such training may increase understanding of traditional birthing practices and may include increasing the role of tribal doulas. New trends Doulas are certified professionals trained to provide continuous, one-on-one emotional and informational support before, during, and after childbirth. They are not medical professionals and do not provide medical services, but collaborate with nurses, obstetricians, midwives, and other health care providers. Use of doula care is rising in the United States, but remains low. Although information about the use of doulas in the state is not available, approximately 6 percent of women nationwide who gave birth in 2011 and 2012 reported receiving care from a doula. This is higher than the 2 percent noted in 2005 when the previous report was released (National U.S. Survey of Women’s Childbearing Experiences, May 2013). Cost for doula care varies widely, but typically is between $500 and $1,500, which usually includes one or more prenatal or postpartum visits in addition to support during labor and delivery. The Minnesota Legislature passed a bill in 2013 designed to increase access to this service by allowing the state’s public health insurance programs to cover it. The state’s decision was being federally reviewed as this article was being written. If it’s approved at the federal level, Minnesota Medicaid would pay for a certified doula’s services. The fact that this improves access for mothers who have health insurance through the state’s Medical Assistance program may mean that doulas may become more widely used statewide. Midwives. Recent research shows that when healthy, low-risk women receive midwifery care their birth outcomes are comparable to or better than outcomes for similar women who receive care from obstetricians (The Lancet, June 2014). The number of births in the state that are attended by a certified nurse-midwife (CNM) has increased over the past 40 years, with 11 percent of state births now attended by a nurse-midwife. Federal legislation related to federal health reform allows CNMs to practice in all birth settings and to be reimbursed by insurance companies. In Minnesota, certified professional midwives (CPMs) also are licensed by the state and reimbursed by some insurance plans. (The difference between CPM and CNM is that a CNM is trained in nursing and midwifery, while a CPM is trained in midwifery.) A licensed birth center is a facility physically separate from a hospital, where women at low-risk of complicated births can receive prenatal care, labor, and give birth. While 99 percent of births occur in hospitals, out-of-hospital births, including those at birth centers, are increasing. Studies show favorable outcomes for low-risk mothers whose care is managed in this setting (Journal of Midwifery & Women’s Health, January/February 2013). Medicaid reimburses medical services provided at these sites, six of which are currently in Minnesota (www.birthcenters.org/birth-center-locator#Minneapo lis%20Minnesota). Advice for expectant mothers: • Choose a health-care provider whose model of care and birth philosophy is similar to your own. Contact your insur-

ance plan well before the expected birth to make sure the insurer covers services performed by the provider you want to choose. • Choose a setting. Research and ask questions about available options and procedures at the birth locations you are considering. The choice of birth setting can influence what kind of provider will deliver your baby, since not all birth settings employ the specific type of clinician you may prefer. • Write a flexible birth plan document. This states your expectations for labor and delivery, including how you want to communicate and make decisions should circumstances change during labor. A doula can help you write your birth plan and communicate it to your health care providers during labor and delivery. Midwives and physicians also can help you write this document. A healthy outcome Options for care attendants and birth settings may be different than when you were born, but the ideal outcome of every birth remains the same: a healthy baby and mother. Today’s trends are expanding the choice of clinician, birth setting, and support personnel, providing more ways for women to achieve exactly that. Katy B. Kozhimannil, PhD, MPA, is an assistant professor in the Division of Health Policy and Management at the University of Minnesota School of Public Health. She gratefully acknowledges the help of Shruthi Kamisetty, Macalester College, in preparing this article.

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September 2014 Minnesota Health care news

Insurance

Medicare changes in 2015 Navigating open enrollment By Stephanie Minor, MPP

edicare changes every January. To prepare for these changes, Medicare beneficiaries must make decisions about their coverage each fall. Not all 2015 changes have been decided yet, but the information currently known is available below to help you start planning for the upcoming Medi-

care annual open enrollment period. This period will last from Oct. 15 to Dec. 7, 2014. During that time, you can change your Medicare Part D and Medicare Advantage plans. Any changes you make will take effect Jan. 1, 2015. Be aware • M Nsure, the Minnesota health insurance marketplace, will also hold open enrollment this fall. MNsure does not provide Medicare-related options. • You may hear that MNsure plan options are offered by companies with the same names that provide Medicare Part C (Medicare Advantage) and Medicare Part D (Prescription Drug) plans. Plans offered through MNsure are not available to Medicare beneficiaries. • Purchasing a Medicare supplemental policy more than six months after enrolling in Medicare Part B may result in the need for further screening and possible denial. Call the Senior LinkAge Line for more information about exceptions. Be informed Medicare-related materials, including Annual Notice of Change and Evidence of Coverage, must be mailed by Sept. 30, 2014. Marketing of plans begins on Oct. 1, 2014. Please read the information you receive from your plan, Medicare, and the Social Security Administration (SSA) to learn about changes to your current Medicare plan that take effect Jan. 1, 2015. This will help you avoid such unpleasant surprises as: • Finding out your prescriptions are no longer covered by your Medicare Prescription Drug Plan. • Discovering that a prescription has been moved to a higher cost-sharing tier, increasing your out-of-pocket cost. • B eing unprepared for increases in the deductible and monthly premium for your Medicare Prescription Drug Plan.

Minnesota Health care news September 2014

• Learning that you no longer qualify for Extra Help with Prescription Drug Costs (also called Low Income Subsidy or LIS), which reduces out-of-pocket costs. • B eing told your Medicare Prescription Drug Plan is no longer a “benchmark plan,” which means that if you qualify for LIS, your monthly Medicare Prescription Drug Plan premium has increased.

• Switch from one Medicare Prescription Drug Plan to another Medicare Prescription Drug Plan. • Drop your Medicare prescription drug coverage completely. Medicare Advantage disenrollment is from Jan. 1, 2015 through Feb. 14, 2015. During disenrollment, you can:

MNsure does not provide Medicare-related options.

• Discovering that the prescription drug coverage included in your retiree plan has changed, perhaps via increased monthly costs or because your plan is no longer considered “creditable coverage.” Creditable coverage allows you to remain in your retiree prescription drug plan and avoid a premium penalty should you later enroll in a Medicare Prescription Drug Plan. Tips In addition to reading the Medicare-related materials you receive, follow these tips:

1. If you receive LIS, follow the mailed instructions you’ll receive from the SSA and/or the Centers for Medicare & Medicaid Services. If asked to send in something, make sure to do so or your LIS eligibility could end in 2015. 2. If you have retiree coverage, the mail you get from the insurer will inform you of changes for 2015 and whether your retiree prescription drug coverage will be considered creditable coverage.

• Switch to Original Medicare. You then have until Feb. 14 to join a Medicare Prescription Drug Plan. Drug coverage begins the first day of the month after the plan receives the enrollment form. During disenrollment, you CANNOT: • Switch from Original Medicare to a Medicare Advantage Plan. • Switch from one Medicare Advantage Plan to another. • Switch from one Medicare Prescription Drug Plan to another. • Join, switch, or drop a Medicare Medical Savings Account Plan. Medicare changes in 2015 to page 32

3. Information you receive about other Medicare Prescription Drug Plan and Medicare Advantage options can help you decide which plan is best for you in 2015. 4. B eginning Oct. 15, 2014, call the Senior LinkAge Line to receive a copy of Health Care Choices for Minnesotans on Medicare to learn what Medicare options are available in Minnesota. When you call (800) 333-2433, press Option 2 to make this request. Medicare open enrollment begins Oct. 15, 2014 and ends Dec. 7, 2014. Changes to your plan take effect Jan. 1, 2015. During open enrollment, you can: • Change from Original Medicare to a Medicare Advantage Plan. • Change from a Medicare Advantage Plan back to Original Medicare. • Switch from one Medicare Advantage Plan to another Medicare Advantage Plan. • Switch from a Medicare Advantage Plan that doesn’t offer drug coverage to a Medicare Advantage Plan that does offer drug coverage. • Switch from a Medicare Advantage Plan that offers drug coverage to a Medicare Advantage Plan that doesn’t offer drug coverage. • Join a Medicare Prescription Drug Plan.

• Leave a Medicare Advantage plan and switch to Original Medicare. Original Medicare coverage begins the first day of the following month.

Minnesota Optometric Association

Doctors on the frontline of eye and vision care Did you know? • Diabetic retinopathy can be controlled and diabetic patients need regular eye exams to maintain vision and good eye health. • Diabetes Type ll can also cause vision changes. • Glaucoma must be diagnosed in early stages in order to prevent vision loss. • All children entering school need a comprehensive eye exam, because vision screenings do not detect a number of eye disorders. • To maintain eye health, everybody from babies to boomers to older adults needs a regular eye exam by a family eye doctor. To locate an optometrist near you and find comprehensive information about eye health visit http://Minnesota.aoa.org September 2014 Minnesota Health care news

B e h av i o r a l h e a lt h

Painkiller addiction

An alarming trend By Pamela Shultz, MD

en’s doctor first prescribed OxyContin following several months of persistent back pain. Nothing had relieved Ken’s pain but the pills finally seemed to do the trick. After a while, Ken had to schedule more doctor’s appointments to get more prescriptions. When his doctor wouldn’t write any more prescriptions, he found another who would, then another and another. He ordered them off the Internet. Ken’s life became consumed by find-

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ing and using the pills that were finally relieving his pain. Amanda’s roommate broke her leg while snowboarding and received a prescription for Vicodin. Although her roommate was instructed to take them “as needed” for pain, she didn’t like the lightheaded, queasy feeling they gave her. The bottle got pushed to the back of the medicine cabinet, until Amanda saw it and thought it might be fun to try the pills. Amanda found she increasingly needed to take more to achieve a similar “high.” That tolerance continued to build and she began to feel sick if she didn’t have Vicodin. Soon it was no longer about getting high, but about getting by. She stole pills from friends’ medicine cabinets and bought them from people at school. Eventually, her financial resources dwindled and she learned she could get more bang for her buck with heroin. Snorting only, she told herself, but she eventually transitioned to intravenous use. Who knew that a few pills used “for fun” would lead her to this? Understanding the opioid problem Amanda and Ken are two of the estimated 4.9 million users of prescription pain relievers in the United States. Their stories are increasingly typical of patients seen at addiction treatment centers across the country. There has been a dramatic rise in addiction to prescription pain relievers and heroin nationwide and Common opioids in Minnesota. Treatment • morphine (Kadian, MS contin) admissions for heroin and • tramadol (Ultram, Ryzolt, ConZip) other opioids accounted • codeine (Tylenol #3) for 20.3 percent of all • hydromorphone (Dilaudid, Exalgo, treatment admissions in Palladone) the Twin Cities in 2012, • hydrocodone (Vicodin, Norco) second only to alcohol admissions. Even more • oxycodone (Percodan, Percocet, OxyContin, Roxicodone, Oxecta) alarming, overdose deaths related to opioid pain med• fentanyl (Sublimaze) ications and heroin have • methadone (Dolophine) more than tripled in the • meperidine (Demerol) past 20 years.

Signs that someone might be addicted to opioids • Has increased the amount or frequency of use • Tries to hide use • Gets irritable or flu-like symptoms if not using • Takes pills to feel normal • Sees multiple doctors or goes to ER frequently to get pills • Has change in personality or behaviors • Scratches skin or “nods off” frequently

Why would someone transition from using prescription opioid painkillers to heroin? Both substances affect the same part of the brain and the addictive potential of prescription opioids and heroin is very similar. “Opioid” is an umbrella term for natural and synthetic medicines based on opium, including heroin. A misconception treatment professionals often hear is, “These were prescribed to me. I’m not addicted.” Opioid painkillers are highly addictive and patients can quickly develop tolerance, leading to escalation of the amount used. When addicted individuals run out of their prescription supply, they may turn to heroin because it is cheaper and more powerful than ever before.

Overdose deaths related to opioid pain medications and heroin have more than tripled.

The current problem arose because the approach to pain management shifted fundamentally in the 1990s, resulting in an enormous increase in prescribing opioid painkillers for not only acute pain cases, but also for chronic, noncancer pain. For example, in 2010 hydrocodone was the most prescribed drug in the U.S., with more than 131 million prescriptions written. These prescribing practices have led to a number of consequences, including dramatic increases in recreational use (because of increased availability), emergency room visits, treatment admissions, and overdose deaths relating to opiates.

How to avoid addiction Anyone can become addicted to opioids. It doesn’t matter what socioeconomic class, age, race, or gender a person is. But there are ways to guard against it: • Stop when your pain stops. Use only what you need and only as long as you need it. Sometimes doctors overprescribe these drugs. The patient has to take responsibility for taking them safely. • If ineffective, don’t continue the prescription. Look honestly at whether these prescriptions are really helping your pain. A dose adjustment may help, but if it doesn’t, don’t continue to

take it. The higher the dose of the medication, the more risk of becoming addicted, or worse, of overdose. • Explore alternative therapies. Opioids are better suited for acute, rather than chronic, pain. (Chronic pain is usually defined as pain that lasts six months or more and is not caused by ongoing injury or inflammation.) Chronic pain sufferers should try non-medication treatments that may, in the long run, allow them to stop pain medications or reduce the need for them. • Communicate with your doctor. A personal or family history of addiction to any substance substantially increases your risk of becoming addicted to pain pills. • Get a second opinion. If you’re concerned about your doctor’s approach, consider a second opinion from another doctor. If you think a loved one is dependent Do: • Bring up your concern when the person is sober. • Express your concern in a caring and honest way. • Talk about the effect drug use has had on you or whatever your loved one cares about most: career, children, sports, physical health. • Have a support person with you or available by phone. Painkiller addiction to page 19

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Calendar Sept. 20

Huntington’s Disease Support Group

The Minnesota Chapter of the Huntington’s Disease Society of America offers this free support group for those affected by Huntington’s Disease. Come make new connections in a safe, caring environment. Call (612) 3710904 or email jmarsolek@hdsa.org for more information. Saturday, Sept. 20, 10:30 a.m.–12 p.m., Oak Grove Lutheran Church, 7045 Lyndale Ave. S., Richfield

Hope for Recovery

NAMI Minnesota presents this free one-day education workshop to provide families and individuals with information, hope, and practical strategies for dealing with the complexities of mental illness. Come learn about treatments, coping strategies, the mental health system, and local resources. For more information or to register, call (651) 645-2948. Saturday, Sept. 20, 9 a.m.–3 p.m., The Basilica of St. Mary, 88 N. 17th St., Minneapolis

Nicotine Anonymous Support Group

HealthEast hosts this support group for anyone seeking freedom from nicotine addiction, including those using cessation programs and nicotine withdrawal aids. Join others on the path to living nicotine-free and smoke-free lives. Call (651) 232-7000 for more information. Monday, Sept. 22, 7–8 p.m., Maplewood Professional Building–Watson Education Center, 1655 Beam Ave., Maplewood

Oct. 2

Heart Transplant Support Group

Allina Health offers this support group for those dealing with issues related to waiting for a heart transplant and life changes after a transplant. Come connect with others on a similar journey. Call (612) 775-5007 to sign up or for more information. Thursday, Oct. 2, 12–1 p.m., Abbott Northwestern Hospital, 800 E. 28th St., Rm. H5091, Minneapolis

Diabetes The number of Americans with diabetes increased from 25.8 million in 2010 to 29.1 million in 2012, according to the Centers for Disease Control and Prevention. This disease affects 9.3 percent of the population and is the seventh-leading cause of death in the U.S. Approximately 25 percent of adults who have diabetes are undiagnosed. Type 2 diabetes, formerly called adult-onset diabetes, is the most common form, accounting for more than 90 percent of all diagnosed cases. Risk factors include obesity, family history, physical inactivity, and getting older. Type 1 diabetes, previously called juvenile-onset diabetes, accounts for about 5 percent of all diagnosed diabetes cases. Risk factors for this type are less welldefined than for type 2 but include autoimmune, genetic, and environmental factors. Complications of either type can include vision loss, heart disease, stroke, kidney failure, and amputation of lower extremities. Currently, there is no cure or failsafe prevention strategy for diabetes. But increasing physical activity and making healthy eating choices can help lower your odds of developing it and help those with diabetes manage their condition.

Oct. 3

Diabetes Support Group

Hennepin County Library offers this free class for those living with diabetes or prediabetes. Come share your experiences and get advice from a health care professional on blood sugar management, diet, and exercise. Call Nokomis Healthy Seniors at (612) 729-5499 to arrange free transportation. Friday, Oct. 3, 1–3 p.m., Nokomis Community Library, 5100 34th Ave. S., Minneapolis

Minnesota Health care news September 2014

Lupus Support Group

Lupus Foundation of Minnesota hosts this support group for individuals affected by lupus, and their support team. Come to connect with others living with lupus, learn more about the disease, and share coping strategies. To learn more or to RSVP, contact Mara at (612) 481-5354 or mara.locketz@gmail.com. Tuesday, Oct. 7, 6:30–8 p.m., Pathways, 3115 Hennepin Ave. S., Minneapolis

Varicose Vein Screening

Park Nicollet offers free screenings for anyone bothered by visible, bulging veins in their legs that cause pain, swelling, or cramping. Surgeons will perform the screening and recommend a course of action. Those covered by Medicare or Medicaid are not eligible due to federal regulations. Call (952) 993-2651 to schedule your screening. Monday, Oct. 13, 10:30–11:30 a.m., Park Nicollet Heart and Vascular Women’s Center, 5th Floor, 6500 Excelsior Blvd., St. Louis Park

HIV and Your Heart

ALS Support Group

The Aliveness Project hosts this free presentation for those living with HIV/AIDS. Come learn about the link between HIV and heart disease and get tips to keep your heart healthy. To RSVP, call (612) 822-7946. For more information, call (612) 822-5433, ext. 213. Thursday, Oct. 23, 6–7:30 p.m., Elsie’s Restaurant, 729 Marshall St. NE, Minneapolis

The ALS Association invites those with ALS and their loved ones to this support group to receive education and support. Come connect, ask questions, and learn more about the disease. No RSVP required. Contact Anne at (612) 672-0484 or anne@alsmn.org for more information. Thursday, Oct. 23, 1–3 p.m., Parkside Professional Center, Ste. 506, 825 S. 8th St., Minneapolis

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

Painkiller addiction from page 17

Remember 1. Only use opioids for severe pain and for as short a time as necessary. You can become addicted even when using them as prescribed.

Anyone can become addicted to opioids.

2. Be aware of your risk factors for addiction and tell your physician about them. The biggest risk is a family history of alcoholism or other addiction.

• Write down what you want to say ahead of time so you’re prepared. Don’t: • Bring up your concern when the person is intoxicated. • Use a blaming tone. • Offer solutions; you are not a chemical dependency professional. • Try to change behaviors. • Do this alone. • Despair or take it personally if nothing changes; you have planted a seed of recovery that may grow when you least expect it.

Help and hope When a loved one is open to professional help—or if you are concerned about your own use—start with a chemical dependency assessment. Addiction treatment centers have professional staff members who conduct confidential, individual screening assessments to determine whether someone has an addiction. An objective assessment is the best way to evaluate if there is a problem, and to get recommendations for treatment to help lead to recovery and sobriety. Pamela Shultz, MD, is board-certified in internal medicine and a diplomate of the American Board of Addiction Medicine. She is the medical director of Hazelden–Center City, a part of the Hazelden Betty Ford Foundation.

3. If you’re concerned about yourself or another person’s use, seek professional help: Get a chemical dependency assessment from an addiction specialist. The sooner you get help, the better. 4. Be sure to properly dispose of unused medications—don’t leave them in your medicine cabinet for later possible use. Do not give them to family or friends. Most counties have safe disposal prescription take-back programs, including: Carver County (www.co.carver.mn.us/departments/PH/medicine.asp) Hennepin County (www.hennepin.us/medicine) Ramsey County (www.co.ramsey.mn.us/ph/rt/ medicine_collection_program.htm) Washington County (www.co.washington.mn.us/meds)

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

• Premature ejaculation

• Emotional pain or physical pain with sexual activity

• Sexual abuse

• Erectile dysfunction (ED)

• Sexual desire discrepancies

• Gender identity disorder

• Sexual harassment

• Gender exploration for children and adolescents

• Sexual offending

• Hepatitis

• Sexual orientation

• Mental health

• Sexual problems

• Orgasm problems

• Transgender health Treatments

Our professional staff members have received specialized training in human sexuality, psychology, psychiatry, and medicine and are credentialed through state and national organizations.

612-626-4702 | www.umphysicians.org September 2014 Min n esota Health care n ews 19

Special focus: Diabetes

Managing diabetes Obstacles? Let your doctor know. By Munir Abid, MD

o discuss tips for managing diabetes, it helps to know the basics of this condition. Diabetes is a disease of the endocrine, or hormone system. It occurs when the body cannot properly utilize glucose, also known as blood sugar. There are two types of diabetes: type 1 and type 2, the latter being the most common form in adults. There are many risk factors for developing diabetes, including genetics and family history, but one of the major risk fac-

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Minnesota Health care news September 2014

tors for type 2 diabetes is obesity. You can lower your risk of type 2 diabetes by eating healthfully, exercising daily, and losing weight. Diabetes control is considered good if the blood glucose level in someone before eating a meal is in the range of 90 to 130 and is 180 or less, depending on the patient, two hours after eating a meal. A routine blood test called HgbA1c provides a good estimate of what someone’s average blood glucose level has been for the preceding two to three months. An A1c (shorthand for HgbA1c) of less than 6.5 percent is considered excellent, and one that is less than 8 percent is quite acceptable. These blood glucose and A1c goals are considered benchmarks, i.e., values that diabetics are encouraged to attain and maintain in order to enjoy good control of their diabetes.

When blood sugar levels refuse to budge, it is not always the patient’s fault.

Rationale for benchmarks Poorly controlled diabetes can cause many complications, including heart disease, blindness, kidney disease, and nerve damage. Multiple research studies have shown that good diabetes control can prevent long-term complications in the vast majority of patients. This is why it is extremely important to achieve and maintain good diabetes control. Struggles As an endocrinologist, the majority of the patients I see have diabetes. I understand the struggle that many patients face when trying to control their blood sugar. Every patient differs, and for some, it is harder to meet benchmarks than it is for others. Too many patients feel ashamed of not reaching their goals for things like blood sugar levels and weight loss, and, as a result, don’t make or keep appointments to see their physician. But not meeting these benchmarks is not a sign of weakness.

If you are struggling to meet the health goals your doctor recommends, this is not the time to avoid medical appointments: This is when a check-up is more important than ever. It is important to understand that the physician is there to help you in these situations.

to detect that he was having high glucose levels during the night and the latter part of the afternoon. This new information was instrumental in helping us tailor his medication regimen to avoid high glucose values during those times, thus helping him to achieve better control of his diabetes.

Teamwork Your doctor can help because he or she stays aware of the newest treatment options, and there continue to be advances in the treatment of both type 1 and type 2 diabetes. There are drugs available now that work via different mechanisms and can be combined to achieve good results. There are major technological advances in insulin delivery systems, and there are now continuous glucose monitoring systems too. All of these tools can be tremendously useful in helping patients achieve better diabetes control. Additional tools are available from your dietitian and diabetes educator, who are also members of your health care team.

Your doctor wants to help you Controlling diabetes is a tough task. However, with proper care and treatment, it can be managed. As an endocrinologist, it is my duty to do whatever I can to help you reach your goals. If the current treatment isn’t working, we can always try different tactics to get you to where you need to be.

Many patients feel ashamed of not reaching their goals … this is not the time to avoid medical appointments.

Research has shown the value of team management for this disease. As a patient, you are the leader of your health care team. Your teammates can’t put their heads together with you to determine a solution to a blood sugar level that refuses to go lower, or a way to better manage whatever problem you’re experiencing, if you don’t alert them to the problem in the first place. Proof teamwork works One of my patients was having problems regulating his blood sugar levels. We figured out that what would work best for him would be a variable-dose insulin regimen based on the amount of carbohydrates he consumed. We arranged for him to meet with a dietitian to learn how to count the carbohydrates in the foods consumed. This would enable him to start self-calculating an accurate insulin dose depending on the actual amount of carbohydrates his food contained, which of course varied from meal to meal. After he learned to count carbohydrates, he was able to give himself the precise amount of insulin his body needed to handle the food he ate at any given time. As a result, his diabetes control improved significantly. Another patient was reluctant to take daily injections of medicine. This reluctance led to inadequately controlled blood sugar levels. When we discussed the problem and she shared the fact that she preferred to avoid injections if possible, she was happy to learn that there was another way to approach controlling her blood sugar levels. Accordingly, her treatment was changed from having daily injections to taking pills before breakfast and supper and having just one injection of an incretin drug every week. (Incretins lower blood glucose levels.) After adopting this revised treatment plan, she was delighted to see an improvement in her blood sugar levels and to experience a corresponding improvement in her overall sense of well-being. Yet another patient was unable to achieve good diabetes control despite following a recommended program of diet, exercise, and medications. We arranged for him to see a diabetes educator to learn how to use a continuous glucose sensor. This device is designed to check tissue glucose every five minutes. Using this device allowed us

When blood sugar levels refuse to budge, it is not always the patient’s fault. For example, a patient’s body changes over time, as everyone’s does. So even a treatment that has been successful may lose its effectiveness with time. In addition, not every treatment works for every patient, and it does take some time to figure out the most effective treatment for each person. Therefore, if you are struggling to reach your benchmarks, please visit your physician. Together, you can battle this disease. Munir Abid, MD, is board-certified in diabetes, metabolism and endocrinology, and internal medicine. He practices with Allina Medical Group, St. Paul.

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Special focus: Diabetes

Diabetes and eye health See the big picture By Matthew Bauer, OD

ecently, a 45-year-old patient came into my office, concerned because his vision had become increasingly blurry during the preceding week. On the day he saw me, he could barely read street signs to get to the clinic. He hadn’t had a physical exam in two or three years and his last eye exam had been about five years earlier. His eye exam with me revealed the cause of the blurriness: diabetes. Detection Unfortunately, this is something that happens fairly regularly in my MSA nearly - MN Healthcare July 2013.pdf 6/12/13 15:23 clinic, since one in 10 adults in the1 U.S. a rate has diabetes,

projected to reach one in three by 2050. Many of my patients are surprised by a diagnosis of diabetes. They often wonder how in the world I can diagnose diabetes from looking at someone’s eyes. The reason is that diabetes can affect any part of the eye at any time while a person has diabetes. If you’ve been told you’re diabetic or prediabetic—or even if you haven’t—it’s helpful to know the symptoms of eye problems that can be caused by this disease. If you experience them, contact your eye doctor without delay. Symptoms Front of the eye The anterior, or front, of the eye, comprises the eyelids, tears, eyeball, and cornea. If there’s eye pain, it often comes from this area because there are no pain receptors in the back of the eye. People with diabetes are more prone to eye infections and dry eyes. If diabetes affects the front of a diabetic’s eye it often produces symptoms of pain, redness, discharge, crusting, light sensitivity, itching, or a feeling of something inside the eye. Any of these symptoms should prompt a visit to the eye doctor. Middle The middle of the eye involves the iris (the colored part of the eye) and the lens. The lens is normally clear, and is responsible for focusing at different distances to keep vision clear. When blood sugar is too high for too long, it can make the lens swell. To understand the symptoms this can produce, imagine having a thin pair of lenses in your glasses and suddenly having a thick pair of lenses. You probably wouldn’t see well with that thick pair since it wasn’t your original lens. This is exactly what happened to my 45-year-old patient whose vision became blurry. The other effect diabetes can have on the lens is to make it cloudy or hazy. This situation is referred to as cataracts. An example of what people see if they have cataracts is to imagine smearing Vaseline over a pair of glasses: Light becomes blocked or distorted, which blurs vision. While most people develop cataracts with age, this condition tends to occur at an earlier age, and progresses more quickly, in diabetics. This can be treated surgically by a procedure that replaces the original lens with an artificial one.

Minnesota Health care news September 2014

Back The back of the eye includes the retina, blood vessels, and optic nerve. The retina takes pictures, which the optic nerve sends to the brain. All parts of the eye must work together to produce a clear picture. A problem in any part of the eye leads to blurred vision or no vision. Vision loss The main reason diabetics lose vision is damage to the retina and its blood vessels, which is a condition called diabetic retinopathy. If blood sugar is uncontrolled, these small, fragile vessels become damaged and can leak. When an eye doctor looks inside the eyes of someone with this damage, he or she sees bleeding, leaking, and/ or resulting swelling inside the retina. In advanced cases, new blood vessels can grow into the retina. These blood vessels are weak, leak, and often cause additional bleeding inside the eye, which accelerates vision loss.

People with 20/20 vision can have severe diabetic eye disease.

Another cause of vision loss is increased pressure inside the eye, which causes an eye disease called glaucoma. People with diabetes are more likely to develop this. If eye pressure becomes too high it compresses the optic nerve, although if it’s detected early by an eye exam, pressure can be lowered with eye drops. In some cases, surgery may be the best way to lower the pressure and prevent compression of the optic nerve. Good news The good news about most diabetic eye problems is that they can be controlled or, in some cases, reversed, by controlling blood sugar levels. While it may be helpful to use eye drops or adjust your diabetic medications depending on your individual situation, remember that diet and exercise are important parts of any treatment plan. Follow the recommendations of the physician monitoring your condition. In advanced cases of diabetes-caused eye problems there are surgical interventions that may prevent blindness. Some involve laser treatment to seal broken blood vessels or areas of the eye that may be leaking fluid that is normally inside the eye. In the last few years, there have been advances in medications than can be injected into the eye to reduce bleeding or leaking. There is a surgical procedure called a vitrectomy that can be performed in advanced cases. However, the best scenario is for someone with diabetes to not reach this point. And the only way to do that is through good blood sugar control. What you can do Diabetes is complicated and there’s no way around that. To try and help those with this condition, here are the five things I tell my patients. 1. Get your eyes checked at least once every year. Currently, only about half of diabetics do so. Having your eyes dilated in an eye exam allows your doctor to examine all parts of your eye for warning signs that you may be unaware you have.

now your HbA1c and have a target value for this number 2. K that you aim to reach and maintain. 3. Lowering your HbA1c even 1 percent can significantly reduce your risk of developing eye complications. Studies have shown that a 1 percent reduction can reduce risk of retinopathy by as much as 44 percent! A 1 percent reduction would be, for example, from 10 percent to 9.9 percent. 4. J ust because you don’t have any eye symptoms doesn’t mean you should avoid getting your eyes checked. People with 20/20 vision can have severe diabetic eye disease. The reason for this apparent contradiction is that sometimes, the retinopathy can occur outside the central area of vision. This is usually temporary and the retinopathy will impact the vision over time if the blood sugar is not controlled. Catching these problems early is important in keeping your vision functioning normally. 5. The longer you live with diabetes, the more likely you are to develop eye complications. Current research suggests that people living with diabetes for 10 years or more have about a 60 percent chance of developing eye problems, even with good blood sugar control. You only have one set of eyes. Have them checked annually for a lifetime of good vision. Matthew Bauer, OD, is a board-certified optometrist, serves as director of eye clinic services at Open Cities Health Center, St. Paul, and is a board member of the Minnesota Optometric Association.

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September 2014 Minnesota Health care news

Special focus: Diabetes

Diabetes and oral health Understanding the link By Sheila Strock, DMD, MPH

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Minnesota Health care news September 2014

ccording to the National Diabetes Statistics Report for 2014 released by the Centers for Disease Control and Prevention, an estimated 9.3 percent of the U.S. population, or 29.1 million people, have diabetes. Unfortunately, many of them are unaware that diabetics have increased susceptibility to oral disease due

to the high blood glucose levels characteristic of diabetes. The most common type of oral problem they face is periodontal (gum) disease. Symptoms of periodontal disease Symptoms of periodontal disease include gums that bleed easily and/or are red, swollen, or tender; pus between the teeth and gums, which indicates the presence of infection; bad breath; or a bad taste in the mouth. If someone notices that he or she has symptoms of periodontal disease but doesn’t visit a dentist to treat the problem, the disease can progress to the point that it damages the gum tissue and bone that support the teeth. In severe cases of gum disease, teeth can become increasingly loose. This often makes chewing painful and results in tooth loss.

It is important for people who have diabetes to inform their dentist.

Other oral problems that diabetics may develop include tooth decay; a diminished flow of saliva, which leads to a chronically dry mouth; a burning sensation of the mouth or tongue; fungal infections such as thrush, which produces painful white patches in the mouth; a change in the way the teeth fit together; ill-fitting dentures; and impaired taste. The diabetes-gum disease connection Research has shown a bidirectional relationship between diabetes and gum disease (Annals of the New York Academy of Sciences, May 2012). “Bidirectional” means that having diabetes can promote the development of periodontal disease, and, conversely, that having periodontal disease is a risk factor for developing type 2 diabetes. The reason for this is due to high levels of glucose in diabetics’ saliva, which promote the growth of bacteria in the mouth. This leads to the formation of plaque, a sticky, germ-filled film that builds

up on teeth. Plaque, in turn, promotes tooth and gum problems. People with diabetes may be more likely than nondiabetics to have severe gum disease. This is important because the oral infection associated with untreated gum disease makes blood glucose levels rise. The good news is that treating periodontal disease in diabetics has been shown to improve their blood glucose control.

3. B e alert for any signs of gum disease in your mouth, and report any changes you notice to your dentist. Schedule regular visits with your dentist for checkups and professional cleanings.

Treating periodontal disease in diabetics has been shown to improve their blood glucose control.

Communicate with your dentist It is important for people who have diabetes to inform their dentist. They also need to tell the dentist which medications they are taking to control their diabetes, as well as their current health status. When the dentist does not know about a health issue such as diabetes, there is increased risk for potential complications during treatment, as I found out early in my career as a dentist. Here’s what happened.

A patient arrived to have several teeth removed. After I gave him local anesthetic, he became weak, confused, agitated, and was sweating. I immediately stopped the procedure, questioned him, and found he had recently been diagnosed with diabetes. Furthermore, he had not eaten that morning. As a result of skipping breakfast his blood glucose level was out of balance, which led to his symptoms. Our dental clinic followed our emergency protocol and managed the patient’s immediate health needs successfully. However, had I known he was diabetic, I either would have made sure that his blood glucose levels were under control at the time of the appointment or would have referred him to a dental specialist who had additional training in caring for patients with more complex medical conditions. What you can do People with diabetes can do a lot to prevent oral health problems. For starters, remember it is very important to inform the dentist about your diabetes. As you and your dentist work together to create a plan of action to maintain your health, your dentist may propose proactive procedures, antibiotic therapy, more frequent dental cleanings, and the use of medicated oral rinses at home. In addition, schedule dental appointments for mornings, since blood glucose levels tend to be under better control at that time of day (as long as you don’t skip breakfast). To help you remember, ask for “morning-only appointments” to be added to your patient chart at the dentist’s office. Good oral hygiene at home and preventive oral health care from the dentist are important for everyone, but especially for diabetics. Recommendations for oral hygiene at home are:

Remember People with diabetes are more susceptible to oral disease because of their high blood glucose levels. This contributes to high glucose in the saliva, which allows bacteria in the mouth to grow, causing plaque formation and the potential for subsequent oral disease.

Managing blood glucose levels reduces the likelihood of problems in the mouth. In turn, maintaining a healthy mouth helps control blood glucose levels. Prevention is key! Control your blood glucose levels, maintain good oral health, and visit your dentist regularly. Sheila Strock, DMD, MPH, is vice president for dental services, Delta Dental of Minnesota. Delta Dental of Minnesota is an authorized licensee of the Delta Dental Plans Association of Oak Brook, Ill.

In the next issue...

• New allergy treatments • Detecting colorectal cancer • Migraine

1. Brush your teeth twice a day for two minutes each time using fluoride toothpaste. 2. Floss your teeth at least once a day. September 2014 Minnesota Health care news

Dermatology

Tat toos Know the risks

By Neil A. Shah, MD, FAAD

Medical complications Complications fall into two main categories: inflammatory reactions, including allergies and scarring; and infections.

lthough tattoos have been part of human history since at least 3,000 B.C.E., modern society has seen a surge in both their acceptance and popularity. One-third of Americans age 18 to 25 have one, and the tattoo industry numbers more than 15,000 parlors generating $2.3 billion annually. With this surge, however, come more complications and requests for tattoo removal. This article will discuss both medical complications and removal options for tattoos.

Inflammatory reactions to tattoos may occur in response to the tattoo process itself or from reaction to colors in tattoo ink. In susceptible individuals, the repetitive needle insertion that is part of the process can cause inflammation that produces excessive scar

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tissue. This tissue can be quite difficult to treat. Certain preexisting skin diseases, including psoriasis, can flare severely in tattooed areas due to the physical trauma of the tattooing process. Pigments used in this process frequently cause allergic reactions in susceptible individuals. It’s important to note that there are no tattoo pigments approved by the Food and Drug Administration for injection into the skin. There is also no standardized testing for these inks to ensure their cleanliness or to determine their tendency to cause allergic reactions. Not all tattoo inks are equally likely to stimulate an allergic reaction. Red is by far the most common color to cause a reaction, while black is the least likely. The allergic reaction can take many forms but always involves itching or discomfort, which can be severe. It can be accompanied by visible changes in the skin, including thickening or bumpiness. Treatment of tattoo-related allergic reactions is extremely difficult because an allergic reaction will persist even if only small amounts of pigment remain in the skin after tattoo removal. Therefore, complete removal of tattoo ink is required to cure an allergic reaction. This can involve costly, painful surgery. Laser tattoo removal has been used to treat allergic reactions but can be very expensive and not completely effective. In some cases, the laser used for tattoo removal may actually convert inert tattoo pigment into one that causes an allergic reaction. An allergic reaction typically occurs within weeks or months of acquiring a tattoo, although it can occur years afterward.

Another type of bacterial infection is caused by bacteria that can live in tattoo ink. The frequency of this infection is, unfortunately, increasing among people who receive tattoos. This type of bacteria can be very difficult to treat, requiring either complete surgical removal of the tattoo or long-term antibiotic therapy. If inks are not sterilized appropriately, these bacteria can easily infect multiple patients before being diagnosed. In most cases these infections produce raised, bumpy skin that appears within a tattooed area four to eight weeks after the tattoo is placed. The infection may spread slowly through the surrounding skin, leading to lumps outside the area initially infected. Removal Surgical removal is an excellent, if expensive, option for smaller tattoos. (Whether a tattoo is considered large depends on its location. For example, a 2-inch one on the wrist is comparatively large but would not be considered large if it were on the chest.) Large tattoos can be removed by staged excision (cut out half now, half later) instead of by all-at-once surgical removal, which can be very costly, painful, or both. Large tattoos also can be removed by lasers and/or dermabrasion. A major advance in tattoo removal has been the development of super-fast lasers, which work by fracturing pigment particles into tiny pieces. This allows the pieces to be disposed of by the body’s own immune cells. Repeated treatment with these lasers can lead to Tattoos page 31

Infections can be caused by both bacteria and viruses. Hepatitis is a serious and potentially fatal viral infection of the liver. This used to be a more common complication of tattoos, but has decreased due to improved hygiene used by tattoo artists. Reusing needles and tattoo inks dramatically increases this risk, which is why hepatitis infection is more common in home- and prison-based tattooing. Until an infected person’s hepatitis becomes advanced, he or she will not know they are infected and can unknowingly infect others through sexual contact. Warts can be caused by the human papillomavirus, usually when there is a preexisting wart infection of the skin that is undetected by the tattoo recipient or artist. The virus is taken up by the tattoo needle and spread to the surrounding skin with each needle puncture. While not a health risk, warts are unsightly and can be difficult to treat. In most cases treatment involves either applying prescription medicine to the affected skin or injecting prescription medicine into the site.

Large tattoos can be removed by staged excision.

Bacterial infections are possible, but uncommon if sterile needles are used. One type is the so-called staph infection, which typically appears within days of receiving a tattoo. Most such skin infections are painful, red, and may drain pus. Anyone with these symptoms should seek immediate diagnosis so that antibiotic treatment can be started promptly to keep the infection from spreading.

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Research

Parkinson’s disease Advances in treatment By Okeanis Vaou, MD

f you know an adult who shuffles or has shaky hands, he or she may be among the more than 1 million Americans affected by Parkinson’s disease (PD). Approximately 60,000 people in this country are diagnosed with PD every year and, due to our aging population, this number is expected to double by 2030.

Although there is not yet a cure, there is exciting potential for one to come from current research and trials of new treatment. What is it? PD is a neurodegenerative disease, which means it is characterized by a continuous loss of nerve cells that produce dopamine in the brain. This loss leads to someone with PD becoming increasingly unable to control bodily movements. Symptoms and diagnosis Symptoms typically occur between age 55 and 65, but can appear earlier. They are not the same in everyone. Even for the same person, symptoms may change over time, since this condition is progressive. Motor symptoms such as rigidity and tremors always start on one side and, as the disease progresses, appear on the other side as well. A diagnosis of PD typically is made if someone has one or more of the following four common symptoms. 1. Rigid muscles. A common early sign of PD is decreased arm swing on one side of the body. 2. Movement that is slow and limited 3. Tremor 4. Difficulty walking and balancing. This includes “gait freeze,” a sudden, brief inability to initiate movement that usually occurs during walking or turning. Treatment options There are many medical options for treating symptoms, and motor symptoms can be treated rather effectively with both medication and exercise. However, treatment of more advanced symptoms can become very challenging and includes many side effects. At that point, surgery can and should be considered. Here is an overview of current treatments and research.

Minnesota Health care news September 2014

Medication Most medications that address the motor symptoms of PD cause side effects. These can include dance-like movements called dyskinesia, low blood pressure, and hallucinations, but many more can occur. New medications can avoid or minimize side effects and include drugs currently being studied as well as those ready for approval by the U.S. Food and Drug Administration (FDA).

There are many medical options for treating symptoms.

Levodopa This drug has been used for years to lessen PD motor problems, but, as with many medications, it can be difficult to maintain constant levels of it in the body. A delivery method designed to overcome this problem is expected to obtain FDA approval this year. It is a portable infusion pump connected to a tube that is surgically placed in the abdomen, with the tip of the pump positioned in the intestine. This has already been approved in more than 30 countries and has proven to be a highly effective way to treat PD motor problems without increasing dyskinesia. In addition to avoiding that side effect (which occurs with other PD medications as well), this delivery method reduces fluctuations in levels of the drug in the body, which are produced by the currently available regular-release form. The main drawbacks to the pump drug-delivery method are that it requires surgery and that complications with the tube have been reported. One advantage of this method of drug delivery is that it is especially useful for people whose PD makes swallowing medication difficult.

PD patients who are able to swallow, however, may be glad to learn that an improved form of oral levodopa is ready to enter the U.S. market. It is an extended-release oral tablet filled with small, levodopa-containing beads that dissolve slowly in the gut. Because slow dissolution makes absorption of levodopa occur over a longer period of time than the currently available oral form, therapeutic levels of the drug are maintained in the body for longer. Studies have shown that it decreases unmedicated time and dyskinesia. A2a inhibitors Because levodopa-like medications can produce dyskinesia, researchers have sought ways to improve treatment of motor symptoms without this side effect. Animal studies have shown that so-called A2a inhibitors do just that. Trials of three different A2a inhibitors show that each produces a mild reduction in PD motor symptoms while producing less dyskinesia than levodopa produces. If an A2a inhibitor is used in conjunction with levodopa, the dose of levodopa can be decreased, thereby further decreasing the risk of dyskinesia and other side effects. Amantadine This is currently the only medication used to treat levodopa-induced dyskinesia. An extended-release formulation of amantadine that is designed to be taken once a day is expected to reach the U.S. market soon. It provides a slow increase of this drug in the body, and so far has shown very good results with minor side effects.

Other medication Numerous medications are in development in multiple clinical trials, and have produced promising preliminary results. One medication currently being studied is a sustained-release medication that is accordion-shaped and encapsulated. When the capsule reaches the stomach, the medication unfolds and is retained in the stomach for up to 12 hours. This drug is designed to combine properties of both regular and sustained-release levodopa, and preliminary results have shown increased motor control without dyskinesia, compared with currently available optimal treatment. Two other medications being studied offer similar improvement. A different type of medication that is used as an adjunct to other PD medications has shown significant improvement in control of PD motor symptoms. Surgery Advances also have been made in surgical treatment of PD. Surgery on part of the brain was found to decrease tremors as long ago as 1950. In the 1990s, a surgical treatment called “deep brain stimulation” (DBS) began being investigated for PD treatment and has become standard practice in treating advanced motor probParkinson’s disease to page 30

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Parkinson’s disease from page 29

lems and dyskinesia. DBS uses a surgically implanted, battery-operated device to electrically stimulate targeted areas in the brain that control movement. This blocks abnormal nerve signals that cause tremor and some PD symptoms. Gene therapy Gene therapy makes the brain grow replacements for nerve cells that produce dopamine. Trials of this treatment have shown promising results but thus far have not shown that gene therapy treatment is better than DBS. Four clinical studies are currently under way.

Endurance training improves some motor symptoms.

Other experimental treatments Because treatment of symptoms becomes less effective as the disease progresses, neuroprotection is that much more important. To date, most trials of potential neuroprotective agents have not produced impressive results. Nicotine and caffeine have shown some preliminary neuroprotective benefits. In addition, among healthy people, a higher urate concentration in the body is associated with a decreased risk of

PD. A large study testing the benefit of higher bodily urate concentrations in people with PD is in progress and so far has produced positive results. Exercise hope Last but not least, exercise such as treadmill training was found to provide long-term benefits in walking and balance for patients with PD. These benefits may imply that exercising regularly throughout adulthood may keep people with PD from developing problems in these areas, and/or may minimize the severity of those problems if they do appear. It also has been found that endurance training improves some motor symptoms in patients with PD. Even though it is not possible to predict when the cure for Parkinson’s disease will be developed, we are closer than we’ve ever been. The large number of studies and clinical trials currently under way, and some of their results, offer more hope than ever before. Okeanis Vaou, MD, is a board-certified neurologist who practices with Noran Neurological Clinic, Minneapolis. She is a specialist in movement disorders and sleep medicine, and treats patients with Parkinson’s disease.

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:

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Minnesota Health care news September 2014

Tattoos from page 27

ing normal skin, which is more noticeable on darker skin. Laser tattoo removal works best on very light white skin with a dark black tattoo. Another change that can be produced by laser removal is mottling of the skin. It is unrealistic to expect skin to return to its pre-tattoo appearance after laser treatment.

highly aesthetically acceptable removal. However, anyone contemplating laser removal should be aware of the following considerations: 1. Laser tattoo removal is not cheap. Four to seven treatments typically are required for permanent removal. While cost varies based on the expertise of the laser operator, tattoo size, and the ink colors involved, this procedure generally costs from many hundreds of dollars to several thousand dollars. As a rule, it costs more to remove a tattoo than it cost to acquire it, regardless of removal method. It is rare for removal to be covered by insurance since it is considered cosmetic surgery.

There are no tattoo pigments approved by the Food and Drug Administration for injection into the skin.

2. Laser tattoo removal does not work on all colors. Colors that can be removed most effectively include black, dark blue, and dark green. Flesh tones, yellows, and oranges can be extremely difficult to get rid of.

3. Laser tattoo removal does not produce normal skin and may lead to permanent changes in the skin’s appearance. Changes can include a loss of pigment, or whitening, in the surround-

Consider carefully Complications, both inflammatory and infectious, should be considered before getting tattooed. Moreover, tattoos should be considered permanent because, while techniques exist to remove them, these techniques are expensive and imperfect. As someone who has seen tattoo complications, I strongly recommend considering the risks and permanence of a tattoo before deciding to acquire one.

Neil A. Shah, MD, FAAD, is a board-certified dermatologist, an adjunct clinical assistant professor at the University of Minnesota Medical School, and the medical director of Clarus Dermatology, PA, St. Anthony.

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Medicare changes in 2015 from page 15

Medicare prescription drug changes in 2015 Plan changes become public information and will be posted at www.Medicare.gov on Oct. 1, 2014.

Annual deductible Initial coverage limit

2014

2015

$310

$320

$2,850

$2,960

Definition Prescription drug costs from $320 to $2,960: Plan pays 75% of the cost and you pay 25%. During this time, you receive a 55% discount for brand-name drugs and a 35% discount on generic drugs.

Coverage gap (Donut hole)

$2,850 to $6,455

$2,960 to $6,680

Donut hole amount has been $4,550.

Donut hole amount will be $4,700.

Catastrophic coverage

Began after $6,455 in total prescription drug costs.

Begins after $6,680 in total prescription drug costs.

Catastrophic coverage cost-sharing

You pay copayments of $2.55 per generic prescription drug and $6.35 per brand-name prescription drug or 5%, whichever is higher.

You pay copayments of $2.65 per generic prescription drug and $6.60 per brand-name prescription drug or 5%, whichever is higher. Medicare changes in 2015 to page 34

Minnesota

Health Care Consumer Association

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. For more information, please visit www.mnhcca.org. We are pleased to present the survery results.

50 40 30 20 10 0

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Percentage of total responses

50 40 30 20 10 Strongly agree

Agree

No opinion

Disagree

60 50 40 30 20 10 0

Strongly agree

Agree

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â&#x20AC;&#x153;A way for you to make a differenceâ&#x20AC;? September 2014 HealthCARE careNEWS news SEPTEMBER 2013 Minnesota MINNESOTA HEALTH

33 33

Medicare changes in 2015 from page 32

5-star special enrollment period Medicare uses information from member satisfaction surveys, plans, and health care providers to give overall performance star ratings to plans. A plan is rated from 1 to 5 stars, with a 5-star rating as excellent. These ratings help you compare plans and will be updated for open enrollment.

Health care choices in 2014–2015 In fall 2014, the Minnesota Board on Aging will publish the 2015 edition of Health Care Choices for Minnesotans on Medicare. The publication will include all Medicare Prescription Drug Plan and Medicare Advantage Plan options available in Minnesota. After Oct. 15, 2014, call Senior LinkAge Line to receive a copy [(800) 333-2433, then press Option 2].

Medicare beneficiaries must make decisions about their coverage each fall.

5-star plans can be found in the Medicare Plan Finder tool at www.Medicare.gov. These plans are marked with a gold triangle with a star and the number 5. The 5-star ratings are important because you can switch to a 5-star Medicare Advantage or Medicare Prescription Drug Plan once from Dec. 8, 2014 through Nov. 30, 2015. This is a special enrollment period available to most Medicare beneficiaries.

Stephanie Minor, MPP, is on the Consumer Choices Team at the Minnesota Board on Aging.

Senior LinkAge Line: A One Stop Shop for Minnesota Seniors, offers free, personalized assistance to Minnesota Medicare beneficiaries of all ages. It also helps Minnesotans access programs that provide free or discounted medications and provides long-term care options counseling. Call (800) 333-2433 or visit www.MinnesotaHelp.info to chat with a specialist. This program is the federally designated State Health Insurance Assistance Program (SHIP) for Minnesota and provides free assistance to help people understand all Medicare options.

Now accepting new patients

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

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

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

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

Minnesota Health care news September 2014

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

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1

for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Add-on to Metformin Victoza® + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) None Insulin detemir + Continued Victoza® Add-on to Victoza® + Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8

mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 ® Table 3: Adverse Reactions reported in ≥5% of Victoza -treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested

Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a

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