Minnesota Health care News Nov. & Dec. 2014 by Minnesota Physician Publishing

Nov./Dec. 2014 â&#x20AC;˘ Volume 12 Number 12

Empower yourself By Marie Dotseth

Inpatient or observation? By Will Phillips

Over-the-counter testing By Kurt Angstman, MD

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Nov./Dec. 2014 • Volume 12 Number 12

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News

Calendar

People

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Perspective Social Security Public Affairs Compassionate Allowances

10 QUESTIONS Lance Svoboda, DDS Hennepin County Medical Center, Mpls.

Caregiving

Empower yourself By Marie Dotseth

Radiology

Stents and brain aneurysms

By Yasha Kadkhodayan, MD

MINNESOTA HEALTH CARE ROUNDTABLE

Honor Roll

014 health care 2 architecture honor roll By MPP staff

Legislation

015 Health and 2 Human Services legislative preview

FORTy-THIRD SESSION

By R ep. Tina Liebling and Matthew Bergeron, JD

26 28 30

The New Face of Health Care

Oncology

Staging cancer

Expanding medical professional relationships

By Noel Laudi, MD, MRCP

Insurance

Thursday, April 23, 2015 • 1:00-4:00 PM

Inpatient or observation? By Will Phillips

Take Care

Over-the-counter testing By Kurt Angstman, MD

Drug Class

Nonsteroidal anti-inflammatory drugs By Amber Altstadt, PharmD, Bernadette Aragon, PharmD, Katherine Montag, PharmD, and Margaret McCann, RPh, BCPS

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Background and Focus: With dramatic population growth, and as baby boomers become senior citizens, the demand for health care is exceeding the supply. Addressing the shortage of medical doctors involves creating new relationships between medical professionals. Training and licensure for Physician Assistants, Advanced Nurse Practitioners, Chiropractors, Respiratory Therapists, Physical Therapists, Home Care Providers, Dentists, and many other health care professionals have become increasingly rigorous and provide expanded support to our health-care delivery system. Greater integration of these professions allows medical doctors to work to the top of their license but requires new pathways for communication and care coordination. Objectives: We will examine many of the new partnerships that are emerging between medical doctors and other medical professionals. We will look at the ways leveraging these new relationships can improve access to care while reducing costs and improving outcomes. We will consider points of resistance to forming these kinds of health care teams and what should be avoided in creating them. We will discuss what the proper oversight for these relationships should entail and how to maximize the coordination of care that they require. Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable. Name Company Address City, State, ZIP Telephone/FAX Card #

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

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News

Youth Cigarette Use Drops, E-Cigarette Use Causes Concern

missioner of health. “At the same time, we are seeing a wild-west approach toward e-cigarettes, which allows tobacco companies Results from the 2014 Minnesota unlimited marketing access to Youth Tobacco Survey show that young men and women. This has led to increasing numbers the percentage of high school of Minnesota high school and students who have smoked cigamiddle school students using rettes in the last 30 days fell e-cigarettes.” from 18.1 percent in 2011 to 10.6 percent in 2014. Use of MDH estimates that 85,900 chewing tobacco and cigars depublic school students in grades clined as well. six to 12 have used an e-cigarette, and 38,400 reported The survey, conducted by having used one in the past 30 the Minnesota Department of days at the time of the survey. Health (MDH) included quesAbout 25 percent of those who tions about e-cigarette use for had tried an e-cigarette said they the first time this year. Results showed that 12.9 percent of high had never used other tobacco products. Because of the rise in school students used an e-cigathe use of e-cigarettes, the overall rette in the past 30 days, while rate of tobacco use stayed steady 28 percent said they had used this year from 2011, at 24.2 one at some point. percent, even though use of any “These new findings indiconventional tobacco product cate that our statewide efforts to fell from 25.8 percent in 2011 to reduce and prevent conventional 19.3 percent in 2014. tobacco use among Minnesota The Centers for Disease Conchildren are working,” said Ed trol and Prevention (CDC) has Ehlinger, MD, Minnesota com-

Minnesota Health care news November/December 2014

released new data about youth tobacco smoking rates nationally. According to the data, nearly 23 percent of high school students in the U.S. currently use a tobacco product. More than 90 percent of those use combustible products such as conventional cigarettes, cigars, hookahs, and pipes. Last January, the 50th Anniversary Surgeon General’s Report estimated that 5.6 million youth currently under age 17 will die early from a cigarette-smoking-related illness. “Nine out of 10 smokers tried their first cigarette by age 18,” said Tim McAfee, MD, MPH, director of the CDC’s Office on Smoking and Health. “We must do more to prevent our youth from using tobacco products, or we will see millions of them suffer and die prematurely as adults. Fully implementing proven tobacco control programs would help keep our youth from falling victim to tobacco.”

MDH Destroys Newborn Screening Data

The Minnesota Department of Health (MDH) has completed the destruction of newborn screening test results on file from before Nov. 16, 2011. It was required to do so as part of a settlement with Minnesota families because the department did not get parental permission to store the data. Aggie Leitheiser, assistant commissioner of health at MDH, said the department destroyed about a million blood spot samples last January, along with most of the test results. “But then it took us some time to go through and find the backups or the extra copies that were in the database system,” she said. “And it just took us time to make sure that we were confident that we had found all the places.” Leitheiser added that Mayo Clinic had previously had a

contract to test the samples, but that it also had destroyed the results. “We’ve been working with them and we have assurance from them through their data collection system and their data analysis that they’ve cleaned everything out as well,” she said.

Patients with Active Asthma Face Higher Heart Attack Risk

Mayo Clinic researchers have discovered that patients with active asthma—those using asthma medications or those who have had unscheduled office or emergency room visits due to their asthma—are twice as likely to have a heart attack. Researchers studied 543 patients who have had heart attacks and 543 patients of the same ages and genders who have not had heart attacks. The average age of the groups was 67 years old; 44 percent of the patients were women. All were treated at health care facilities in Rochester between 2002 and 2006. Within the group of patients who have had heart attacks, 81 had asthma. Of those, 44 had active asthma. Researchers then compared the two groups while controlling for established heart attack risk factors including age, obesity, high blood pressure, smoking, diabetes, high cholesterol, a history of coronary heart disease, and conditions such as chronic obstructive pulmonary disease. According to the results, patients with inactive asthma were not at an increased risk for having a heart attack. However, those with active asthma were at a 70 percent increased risk. “Lifesaving medications for acute heart attack and asthma attack are different; treatment for one potentially can make conditions worse or life-threatening for the other,” said Young Juhn, MD, senior author of the study and a physician at Mayo Clinic. “Asthma patients need to be aware of this potential issue and should have a care plan for

symptoms for asthma or heart attack.” According to Duk Won Bang, MD, PhD, first author of the study and a former Mayo Clinic research fellow, patients with active asthma and a history of symptoms like chest discomfort or shortness of breath should be evaluated for potential heart disease. He added that physicians should be educating asthma patients about the need to control symptoms and use medications properly to prevent a heart attack.

Love

The results were presented at the American Heart Association’s Scientific Sessions 2014 in Chicago, Ill., in mid-November.

Minnesotans Unsure How They Will Pay for Care as They Age

According to the Minnesota Department of Health (MDH), 70 percent of people aged 65 and older will need long-term care eventually. However, a survey from the Minnesota Department of Human Services and the Minnesota Board on Aging shows that 32 percent of respondents in Minnesota don’t have a plan for how they would pay for that care, while 13 percent indicated they expect to use government programs to cover costs. The survey was conducted at the Minnesota State Fair from Aug. 21 to Sept. 1 and focused on retirement and long-term care planning concerns. A total of 2,624 people participated in the survey. According to officials, results have consistently shown that Minnesotans don’t know how they would pay for long-term care and that losing health insurance and needing care are major concerns for survey participants. This year, almost 48 percent answered that this was their biggest concern. In addition, 34 percent of participants said running out of money was their biggest concern; 11 percent said it was

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News to page 6 November/December 2014 Minnesota Health care news

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being a burden to family; and 7 percent said it was not being able to save for retirement. “The need for Minnesotans to prepare for their long-term care becomes more urgent when we consider that the numbers of Minnesotans over age 65 will double between now and 2030,” said Lucinda Jesson, Department of Human Services commissioner. “By 2030, one of every four Minnesotans will be over 65 compared to one in eight today.” In 2012, the DaytonPrettner Solon Administration started an initiative called Own Your Future to address the ongoing trend and help Minnesotans plan for long-term care and associated costs. When asked where they would go to purchase a product to pay for long-term care, more than 40 percent said they didn’t know, while 29 percent would go to a financial advisor, 22 percent would go to

an insurance agent, 11 percent would utilize the Own Your Future website, and 17 percent would use Senior LinkAge Line, a service of the Minnesota Board on Aging.

Alternative Therapies Reduce Pain, Anxiety For Cancer Patients Allina Health researchers have conducted a study that shows alternative medical therapies such as acupuncture and massage help reduce pain and anxiety for cancer patients.

Researchers analyzed data from more than 1,800 cancer patients who had received an alternative therapy in addition to the standard treatment at least one time during hospitalization at Abbott Northwestern Hospital between July 1, 2009 and Dec. 31, 2012. Patients filled out questionnaires before and after each alternative therapy session,

rating their levels of pain and anxiety on a 10-point scale. The results show that patients who received an alternative therapy in addition to their traditional treatment reported a 47 percent average reduction in pain levels and a 56 percent average reduction in anxiety levels. Those with lung, bronchus, and trachea cancer experienced the most dramatic decline in pain levels, while those with prostate cancer reported the largest decline in anxiety levels. Specifically, patients reported that acupressure, acupuncture, reflexology, and therapeutic body massage were most effective in reducing pain, while no notable difference was found between the treatments with respect to reducing anxiety. “These findings are really important as we start moving into a patient-centered realm of how medical care is provided,” said Jeff Dusek, PhD, research director at the Penny George In-

stitute for Health and Healing at Abbott. “We’re trying to do the best for patients clinically with all the best that Western medicine can provide, but the psychosocial and emotional parts of the patients are also important.” Researchers say the results suggest alternative therapies potentially could play a role in reducing the use of opioid pain medications for cancer patients. “We think they work together, synergistically and physiologically,” said Dusek. “That’s our goal: to maximize the benefit for patients and to decrease any risk from other therapies that are used to reduce pain and anxiety.” The results were published in the Journal of the National Cancer Institute Monographs. Next, researchers plan to study how long these alternative methods reduce pain and anxiety levels in patients.

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Minnesota Health care news November/December 2014

9/23/14 4:46 PM

People Edwin Bogonko, MD, board-certified in internal medicine, has been named chair of the state’s Task Force on Immigrant International Medical Graduates in addition to serving as clinical director of medicine and lead hospitalist at St. Francis Regional Medical Center, Shakopee. He earned a medical degree from the University of Nairobi, Kenya, and Edwin Bogonko, graduated from Physician Leadership College, UniMD versity of St. Thomas, St. Paul. The task force will develop strategies to integrate immigrant physicians into Minnesota’s health-care delivery system and recommend them to the commissioner of health and the Legislature in January 2015. David Herman, MD, MS, has been appointed CEO of Essentia Health effective early 2015, replacing retiring CEO Peter E. Person, MD, MBA. Herman, board-certified in ophthalmology, completed medical school and an ophthalmology residency at Mayo; a fellowship in ocular immunology and uveitis at the NIH’s National Eye Institute, Bethesda, Md.; and a master’s in medical management at the University of Texas–Dallas. He most recently served as president/ CEO of Vidant Health, an integrated health care system in North Carolina.

Maria del Pilar HoenackCadavid, MD

David Herman, MD, MS

Maria del Pilar Hoenack-Cadavid, MD, board-certified in geriatric medicine and internal medicine, has joined Courage Kenny Rehabilitation Associates. She earned a medical degree from Juan N. Corpas Medical School in Bogota, Colombia, and served both an internal medicine residency and a fellowship in geriatric medicine at Hennepin County Medical Center, Minneapolis.

Kristi Estabrook, MD, board-certified in psychiatry, has joined Essentia Health–St. Mary’s Medical Center, Duluth. She will be part of a new program offering comprehensive mental health consultation services to hospitalized patients and patients seen in the Emergency Department. She will care for both children and adults. Estabrook earned a medical degree from Kristi Estabrook, the Medical College of Wisconsin, Milwaukee, and MD completed both a residency in adult psychiatry and a psychosomatic fellowship at the Medical College of Wisconsin Affiliated Hospitals, Milwaukee.

Kenneth D. Holmen, MD

Kenneth D. Holmen, MD, has been named president and CEO of CentraCare Health, St. Cloud, effective Jan. 1, 2015. He has served as vice president of physician strategies and business development for HealthPartners, headquartered in Bloomington, since 2004. During that time, he also was chief medical officer and vice president for medical affairs at Regions Hospital. Holmen replaces Terry Pladson, MD, who will retire Dec. 31.

November/December 2014 Minnesota Health care news

Perspective

Compassionate Allowances Hastening disability benefits for those who need them the most

ast year, the federal Social Security Administration (SSA) announced that 25 medical conditions had been added to its Compassionate Allowances list of conditions for which disability applications are processed faster than most such requests.

For more information about Compassionate Allowances and to see a list of all medical conditions covered by this program, visit: www.socialsecurity.gov/ compassionateallowances For general Social Security information, visit: www.socialsecurity.gov/myaccount/ For more information about Cancer Legal Line, visit: www.cancerlegalline.org Minnesota Health Care News thanks Jim Czechowicz, SSA Public Affairs Specialist, St. Paul, for providing the Social Security references.

The Compassionate Allowances program expedites disability determinations for people who have the most serious disabilities, to ensure they receive their benefit decisions within days instead of months or years. These conditions primarily include certain cancers, adult brain disorders, and a number of rare disorders that affect children. By definition, these conditions are so severe that SSA does not need to fully develop an applicant’s work history to make a decision. As a result, it eliminated the work history part of the application process for people who have been diagnosed with one or more of the medical conditions on the list. Currently, the number of conditions in the fast-tracked disability determination process total 225.

What is disability? SSA defines ‘disability’ based on someone’s inability to work. It pays benefits only for total disability. No benefits are paid for partial disability or for short-term disability. People are considered disabled according to SSA rules if they meet all of the following requirements: • They cannot do the work that they did before their diagnosis. • SSA determines that they cannot adjust to other work because of their medical condition(s). • Their disability has lasted or is expected to last for at least one year or to result in death. Since the Compassionate Allowances program began in October 2008, approximately 200,000 Americans with severe disabilities have been approved quickly, usually within two weeks. This compares with an average three- to five-month wait for applicants whose medical conditions are not on the list. Compassionate Allowances conditions are selected using information received at public outreach hearings, comments received from the Social Security and Disability Determination Services communities, advice from medical and scientific experts, and research with the National Institutes of Health. The SSA also considers which conditions are most likely to meet its current definition of disability.

Minnesota Health care news November/December 2014

Compassionate Allowances in action Two examples of families that benefited from this program are provided by J. Lindsay Flint, Esq., director of legal services for Cancer Legal Line, a nonprofit organization that advises people who have been diagnosed with cancer. “A family had three children in elementary school. The father had been very recently diagnosed with advanced pancreatic cancer and the mother didn’t work outside the home. We advised them to apply immediately for SSDI [Social Security Disability Insurance] as the father would qualify for the CA [Compassionate Allowances].” Another case involved a family in which “the father had been diagnosed with non-Hodgkin lymphoma. The family’s total income was only $1,200 a month. Given the father’s diagnosis, he would be automatically approved for SSDI” under the Compassionate Allowances program, Flint reports.

Applying for disability benefits There is no special application for Compassionate Allowances because this program is not separate from the Social Security Disability Insurance (SSDI) or Supplemental Security Income (SSI) programs. Individuals who have a condition that is on the Compassionate Allowances list apply for benefits using the standard process for filing claims for SSDI, SSI, or for both SSDI and SSI benefits. Application for disability benefits may be filed online or in person. Regardless of which application method you choose, start by looking at the Disability Starter Kit. The kit will help you prepare for your application. It will also help people who are filing in person prepare for the interview that is part of the in-person application procedure. The kit is online at: www.socialsecurity. gov/disability/disability_starter_kits.htm You can request a copy of the kit by calling the tollfree numbers (800) 772-1213 or TTY (800) 325-0778. Online application An online application for disability benefits may be filed at: www.socialsecurity.gov/applyfordisability In-person application You may also make an appointment to apply in person at your local Social Security office by calling (800) 772-1213 or TTY (800) 325-0778.

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10 Q u e s t i o n s

Oral-maxillofacial surgery Lance Svoboda, DDS Dr. Svoboda is an oral-maxillofacial surgeon at Hennepin County Medical Center, Minneapolis.

What special training is required to become an oral-maxillofacial surgeon? A four- to six-year residency program after dental school is required. During residency, in addition to expanding our dental skills beyond those of general dentistry we train extensively to acquire skills in general surgery, neurosurgery, and anesthesia. Training in these areas is essential for treating many of the complex patients we see. Have advances been made in the area of dental implants? Yes, from materials to prosthetic components, many aspects of dental implants have seen improvements. The earliest known implants date to 600 A.D. among the Mayans, who replaced missing teeth with jade and seashell. A major advance occurred in the 1950s, when it was discovered that titanium is especially good at fusing to bone. Fusing is what we want an implant to do, because an implant is placed into someone’s jawbone. Once it has fused in place an artificial tooth called a crown is attached to the implant. With current technology, an implant in a mouth that has healthy tissue and is not exposed to excessive biomechanical force—don’t chew ice or use teeth to open bottles!— may last 10 to 15 years. Research is ongoing to improve implants’ longevity and appearance. Please tell us how your specialty helps patients who have obstructive sleep apnea (OSA). It’s important to treat OSA because this condition raises the risk of stroke, high blood pressure, and heart failure. OSA is an interruption of breathing during sleep, caused by someone’s airway collapsing while he or she sleeps. In certain cases where someone with OSA cannot tolerate traditional treatments such as the CPAP breathing mask, an oral-maxillofacial surgeon can perform orthognathic surgery. This procedure has been shown to be effective in keeping the person’s airway open during sleep by surgically repositioning the upper and lower jaw.

What is corrective jaw surgery? Another name for this is orthognathic surgery, which surgically repositions one or both jaws. In addition to being used to remedy certain OSA cases, this surgery usually is indicated when there are significant growth disturbances of the jaws and facial skeleton. These disturbances can arise in people with certain metabolic conditions such as acromegaly. Orthognathic surgery also is used for post-traumatic reconstruction. I have performed it to reconstruct the face of someone who was in a car accident and was not wearing a seatbelt. Other conditions that may require orthognathic surgery include difficulty chewing and swallowing, chronic jaw pain, excessive tooth wear, a receding chin, and a protruding jaw. What should people know about oral cancer and tobacco products? Tobacco products cause oral cancer. Chewing tobacco and snuff, so-called “smokeless” tobacco, contain 28 cancer-causing agents, according to the National Cancer Institute. Cigarettes contain more than 60 cancer-causing agents. Smokeless tobacco can cause cancer in the cheek, gums, and lips; esophageal cancer and pancreatic cancer; and may cause heart disease and gum disease. Smokeless tobacco can discolor teeth and cause bad breath, as well, according to the Johns Hopkins School of Medicine, Baltimore. Johns Hopkins also states that 80 percent of people with oral cancers use tobacco. Cigars and pipes are not safe, either. Compared with nonsmokers, regular cigar smokers are four to 10 times more likely to die from oral cancer, esophageal cancer, and laryngeal cancer. Early detection is extremely important. If cancer is present, the earlier it’s detected, the better the outcome. Your dentist is the first line of defense in detecting any abnormal areas in the

mouth, so it is important to have routine visits with your dentist not only for oral cancer screening, but also for overall oral health. What kinds of cosmetic facial surgery are performed by oral-maxillofacial surgeons? One type is elective facial cosmetic surgeries. Oral-maxillofacial surgeons also have been involved in facial transplants. There have been a few such transplants throughout the world in the past few years. It’s my understanding that all of them were for patients who had extensive loss of facial tissue as the result of an accident. The medical team that performed these procedures included surgeons from numerous specialties, including oral-maxillofacial surgeons, plastic surgeons, and vascular surgeons. The difficult aspect of this type of procedure is getting facial muscles to function post-surgery. Without this, the face will not be able to express emotion or move properly.

olence. Immediate medical care for these patients is prioritized, with life-threatening injuries treated first. At times, there may be more than one surgeon operating simultaneously on the same patient. I may be repairing the patient’s jaw area while a different surgeon is repairing another part of the same person.

The Mayans replaced missing teeth with jade and seashell.

TMJ: What should people know about it? The “TMJ” is the temporomandibular joint. This joint allows movement of the lower jaw and is located just in front of each ear. Pain of this joint is not uncommon. Symptoms of a TMJ problem include pain with or without using the joint and, sometimes, hearing clicking or popping noises when using the joint. Most patients with TMJ pain can be helped nonsurgically by a dental TMJ specialist via physical therapy, diet modification, or a splint. What types of traumatic facial injuries do you see most often? I see all types of facial injuries from gunshot trauma, animal bites, automobile accidents, and bike injuries. The most common, though, are facial fractures from sporting events or interpersonal vi-

Please help us understand the most common oral-maxillofacial hockey injuries and how they can be minimized. The most common ones include teeth that are fractured or avulsed (knocked out). Wearing a mouth guard and a helmet with a face shield can reduce the chance of this occurring. If a tooth does get knocked out, whether it’s a baby tooth or an adult one, here’s what to do: • It is important to keep the tooth moist in milk until it is replanted. Water is not suitable. • The sooner the tooth is replanted, the better. See a dentist or oral surgeon as soon as possible.

Are there developments on the horizon that may change your field? Recombinant bone morphogenetic protein is a genetically engineered version of a naturally occurring protein that initiates bone growth in targeted areas. In certain cases, using this can decrease surgical time by not having to harvest the patient’s bone. Stereolithography creates a three-dimensional, exact replica of someone’s skull from a CT scan. Oral-maxillofacial surgeons use this replica in planning complex cases and reconstructions. Both developments can potentially reduce the length of time a patient is in surgery and improve the quality of the end result.

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November/December 2014 Minnesota Health care news

caregiving

Empower yourself Help your health care team help you By Marie Dotseth

eventy pages. That’s the average amount of paper a typical patient is handed when discharged from a hospital. Little wonder that many patient instructions go largely or entirely unread.

But a new patient engagement campaign developed by the Minnesota Alliance for Patient Safety (MAPS) offers a short “to-do”

list that tells patients how to help their health care team keep them healthy and safe: Patients have a critically important role in supporting their health care team. This campaign, “You: Your Own Best Medicine” (www.ownbestmedicine.mn), is funded by a grant from the Minnesota Hospital Association.

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Minnesota Health care news November/December 2014

The problem Research shows that serious patient harm can occur during transitions between stages of care, such as between hospital and home, primary care and specialty care, outpatient surgery and the pharmacy, or home care and physical therapy. During these medical transitions, patients as well as health care providers are more likely to make mistakes that lead to dangerous patient safety problems. For example, 19 percent of patients suffer an adverse event following discharge from a hospital. Sixty-two percent of those events happen because of insufficient communication between the hospital and the physician who cares for a patient after she or he leaves the hospital. Failures of care coordination cost an estimated $35 billion per year, according to an analysis published in the Journal of the American Medical Association (2012). A staggering $192 billion worth of overtreatment occurs every year, according to the same analysis. Much of this waste stems from lack of coordination. What kinds of breakdowns occur during medical transitions? Research shows that 38 percent of hospital discharge summaries did not include lab results and 21 percent did not list discharge medications. One study of pediatricians found that 49 percent of the time no information whatsoever was sent from a pediatrician to a specialist (Archives of Pediatric and Adolescent Medicine 2000). At the same time, specialists only sent feedback to the referring physician 55 percent of the time, according to the study. Patients, too, have a great deal of room for improvement. Research shows that almost one-third (31 percent) of prescriptions are unfilled by patients (Annals of Internal Medicine 2014). Fourteen percent of patients never make recommended follow-up appointments (Journal of Family Practice 1998). Too many patients fail to monitor and promptly act on warning signs associated with their conditions. Many patients fail to share important parts of their health history with caregivers, leaving their medical team dangerously underinformed. Causes As part of developing our patient engagement campaign we listened carefully to patients. In late 2013, we recruited 100 people statewide to participate in a week of online discussion about managing health care. Participants were a relatively diverse group racially, ethnically, economically, and geographically, although they all had chronic medical conditions. To encourage candor, their online comments were anonymous. Among other things, we asked these patients why they weren’t more engaged in coordinating their health care. Many patients told us they believe that little is expected of them. They assume their care management responsibilities are modest to nonexistent. Promotion of electronic medical record systems, as well as traditional “trust your doctor” attitudes cause many patients to conclude that it is okay, even expected, for them to be passive when receiving health care. Another reason for lack of patient engagement is that patients aren’t sure what to do differently. They are willing to do more, within limits, but they need clear, specific, and doable assignments.

Patients also told us that the materials they currently receive from health care providers are often too voluminous and jargon-laden. They want instructions they can read and understand in seconds, not minutes or hours. We showed the 100 participants samples of patient safety materials in order to learn more about the optimal volume, tone, and level of detail to use in communications. Solution Patient “to-do” list MAPS incorporated that feedback into our patient engagement campaign. The campaign’s primary message is that patients need to empower themselves by playing a central role in helping their health care team help them. The campaign tells patients precisely what to do to protect themselves, via a brief to-do list of four simple, patient-safety-related tasks. 1. K eep a list of the medications you take, and share it with health care providers. 2. Gather test results in one place, and share them with health care providers. 3. Write a list of recommended next steps, and promptly act on them. 4. Identify, monitor, and promptly act on warning signs associated with your condition(s). Empower yourself to page 34

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Radiology

Stents and brain aneurysms Preventing and treating a potentially devastating condition By Yasha Kadkhodayan, MD

Telephone Equipment Distribution (TED) Program

f people have heard of stents, they’ve usually heard of them used to open up clogged arteries in people who have certain types of heart problems. For those who haven’t heard of stents,

Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.

1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services

Minnesota Health care news November/December 2014

they are mesh tubes that can be surgically inserted into a naturally occurring passageway in the body, like a blood vessel, to keep it open. In addition to use in heart patients, stents also are used for treating brain aneurysms. What is a brain aneurysm? A brain aneurysm is a weak area in the wall of a blood vessel that supplies the brain. Because this area is weak, blood pressure makes the vessel wall bulge outward. While some aneurysms produce symptoms because their bulge presses on the brain, most brain aneurysms don’t cause symptoms unless they rupture. Rupture of brain aneurysms, which typically occurs without warning, usually results in bleeding within the brain. As one can imagine, this is a devastating event. Generally, one-third of people to whom this happens die immediately, one-third suffer substantial permanent neurological injury, and one-third recover enough to independently manage their activities of daily living. Who is at risk? Brain aneurysms are relatively common. According to the Brain Aneurysm Foundation (www.bafound.org), an estimated 6 million people in the United States live with an unruptured brain aneurysm, or one in 50 people. This medical condition usually occurs in people aged 35 to 60, but can occur in children as well. The average age of someone whose aneurysm ruptures is 50. In Minnesota, more than 300 people experience this every year (Minnesota Stroke Registry Program Report 2008–2012). Risk factors that may lead to the formation and rupture of brain aneurysms include smoking, high blood pressure, connective tissue disease, a family history of brain aneurysms, the use of stimulant drugs such as cocaine and meth, and the presence of certain medical conditions that include polycystic kidney disease.

Symptoms Symptoms of a ruptured brain aneurysm include the sudden onset of what has been described as the worst headache of your life, loss of consciousness, nausea and vomiting, neck stiffness, blurry or double vision, sudden weakness or numbness, sensitivity to light, seizure, or one drooping eyelid. Sometimes brain aneurysms are discovered before they rupture, when patients have their heads radiologically scanned for another reason, such as headaches, dizziness, changes in vision, or stroke symptoms. Treatment When faced with an unexpectedly detected aneurysm, the patient and his or her doctor have to decide whether treatment is appropriate. This decision consists of weighing the small but significant risks of treatment, which include stroke and death, against the small chance the aneurysm may rupture on its own if nothing is done. Traditionally, treatment of brain aneurysms has been open brain surgery. Since the mid-1990s, however, an increasing number of aneurysms have been treated from inside the blood vessels, which are accessed via a small incision made in the groin. If this treatment is chosen it will be performed by a neurointerventional radiologist, who is a radiologist specializing in image-guided procedures to treat neurological diseases.

Looking ahead Using stents to treat brain aneurysms is a relatively recent therapy; the first stent system designed specifically for use in the brain was introduced in 2002. Consequently, we are still learning about this treatment’s long-term success. However, most patients treated this way have their risk of an aneurysm rupturing or re-rupturing reduced. Furthermore, numerous new stent-like devices to treat brain aneurysms currently are being evaluated for FDA approval. One such device is known as the WEB aneurysm embolization system. Preliminary results of this method from 12 European study centers are encouraging: More than one year after receiving this treatment, 90 percent of patients continued to have their aneurysm sealed off as shown by radiologic imaging. (These results were presented at the November 2013 meeting of the World Federation of Interventional and Therapeutic Neuroradiology in Buenos Aires.) We expect to see continued expansion of the exciting potential for the use of stents in image-guided radiological procedures to treat complex neurovascular diseases.

A brain aneurysm is a weak area in the wall of a blood vessel that supplies the brain.

Yasha Kadkhodayan, MD, is board-certified in radiology with subspecialization in neuroradiology. He practices interventional neuroradiology with Consulting Radiologists, Ltd., at Abbott Northwestern Hospital, Minneapolis.

“Image-guided procedures” means that the radiologist sees the procedure that she or he is performing inside the patient in real time, because X-ray or other scanning of the patient is being done concurrently. Sometimes, these procedures involve using a stent; if so, they are done under general anesthesia in an operating room. All patients receiving a stent stay in the hospital at least one night afterward, but most patients go home the next morning. Different stent applications Treating an aneurysm from inside the blood vessels usually means packing it with soft metal coils that cause blood to clot inside the aneurysm. This prevents the aneurysm from rupturing. Coils are introduced using a very thin plastic tube that is navigated to the brain from the groin using X-ray to guide the way. Sometimes, aneurysms have a neck that is too wide for coiling alone, because the coils would simply fall out of the aneurysm and block a normal brain artery, which would cause a stroke. In order to keep the coils in the aneurysm, a stent can be placed in the artery, across the neck of the aneurysm. This serves as a scaffold that keeps the coils inside the aneurysm. There are also specialized stents that divert blood flow away from the aneurysm. Immediately after placing a flow diverter stent across the neck of an aneurysm, blood flow into the aneurysm slows. Over time, blood no longer enters the aneurysm because the body develops a new blood vessel lining over the stent. This seals off the aneurysm, which subsequently shrinks.

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 November/December 2014 Minnesota Health care news

Drug class

Nonsteroidal anti-inflammatory drugs Effective therapy, potential risks By Amber Altstadt, PharmD, Bernadette Aragon, PharmD, Katherine Montag, PharmD, and Margaret McCann, RPh, BCPS

onsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used pain medicines. So common, that according to the American Gastroenterological Association, approximately 30 million people take them every day. They’re widely available as over-the-counter (OTC) medicines such as low-dose naproxen or ibuprofen, but also may be prescribed by a

health care provider. Some, such as celecoxib (also called Celebrex), are only available with a prescription. While often affordable and effective for a variety of ailments, this class of medicine may pose risks that are important to consider. Because NSAIDs may work differently in different patients, and because they may cause side effects that could be harmful, it is

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Minnesota Health care news November/December 2014

5/25/11 10:58 AM

important to discuss the potential risks and benefits with your pharmacist or health care provider prior to starting any NSAID, whether prescribed or OTC. Here’s a look at what you need to know, and why you should ask your doctor or pharmacist for help identifying which NSAID, if any, is right for you.

Discuss the potential risks and benefits with your pharmacist or health care provider.

Uses NSAIDs often are used to relieve symptoms of pain and or inflammation associated with headaches, arthritis, menstrual cramps, gout, dental ailments, and minor injuries. Different types of this medicine may be used depending on what is being treated. For example, indomethacin and naproxen are the NSAIDs of choice for gout attacks.

such as bleeding and stomach ulcers. It’s important to note that bleeding and stomach ulcer symptoms can arise any time during treatment with NSAIDs and can occur without warning. NSAIDs such as ibuprofen and naproxen are more likely than others to cause this kind of damage. NSAIDs such as celecoxib (Celebrex) present a smaller risk of bleeding and stomach ulcers. Although anyone who takes an NSAID is at risk of developing stomach problems, the risk increases for people who have any of the following characteristics: • Regular, long-term use of NSAIDs • Age greater than 65

Some people do not tolerate oral NSAIDs or may be at a higher risk of side effects from them. For these people, topical NSAIDs— those that are applied to and absorbed through the skin—are generally used, because topical forms of a drug tend to have minimal effects outside the area of application. Topical forms of this drug class are commonly used when pain is limited to a specific area, such as osteoarthritis of the knee. These forms may exist as a patch, gel, spray, or ointment. Aspirin is the only NSAID used to promote heart health, with low daily doses prescribed to prevent heart attack or stroke in certain patients. Slightly higher doses may be used to promote heart health after stroke and after certain types of heart surgery, or in patients who have atrial fibrillation, which is a type of heart rhythm problem.

• History of stomach ulcers • Excessive alcohol intake • Heavy smoker • Simultaneously taking the following medicines: }} corticosteroids (such as prednisone) Nonsteroidal anti-inflammatory drugs to page 19

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How they work As their name implies, nonsteroidal anti-inflammatory drugs are not steroids but reduce inflammation, as do steroids. NSAIDs accomplish this by reducing the body’s production of prostaglandins, which promote inflammation. Unfortunately, since prostaglandins also protect the stomach and promote blood clotting, NSAIDs’ reduction of them can lead to such adverse effects as ulcers in the stomach and intestines, and an increased risk of bleeding in the gastrointestinal tract. Newer NSAIDS have been developed that, for some people, may adequately reduce pain and inflammation in joints without adversely affecting the stomach and intestines.

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Side effects While benefits of NSAID therapy often outweigh risks, side effects can occur. Among the more potentially serious ones are those that involve the gastrointestinal tract. Contact your doctor immediately if you experience any of the following: stomach pain; a feeling of indigestion; dark, tarry stool; or vomiting blood. These symptoms may indicate bleeding in the stomach or intestines. Gastrointestinal tract side effects may include mild stomach upset as well as bleeding in the stomach or intestines. Mild stomach upset can generally be avoided by taking the medication with food and does not predict development of more serious stomach problems

November/December 2014 Minnesota Health care news INFORMATION Job Number

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Calendar Dec. 8

ADD/ADHD Parent Support Group

PrairieCare presents this free support group for parents of children with ADD or ADHD. Speaker Megan Bearce, LMFT, will conduct a presentation on perfectionism and how it impacts the mind, body, and relationships, as well as strategies for support and success. For more information or to sign up, call Steve at (651) 748-7594. Monday, Dec. 8, 6:30–8:30 p.m., District Education Center, 2520 12th Ave. E., North St. Paul

Bariatric Support Group

Park Nicollet offers this group for those who have undergone or are pursuing bariatric surgery. Join bariatric surgery team members to learn strategies for well-being and share your personal experiences in a safe, welcoming space. No registration required. Call (952) 993-3180 for more information. Wednesday, Dec. 10, 5:30–6:30 p.m., Park Nicollet Bariatric Surgery Center, Meadowbrook Building, 2nd Flr., W200, 3931 Louisiana Ave., St. Louis Park

Stroke Caregiver Support Group

North Memorial hosts this support group for care partners of stroke survivors. Come learn how to care for your loved one and get support from others who understand. No registration required. Call (763) 581-3650 for more information. Wednesday, Dec. 17, 2–3 p.m., North Memorial Medical Center, Stroke Center, Plaza Level, 3300 Oakdale Ave. N., Robbinsdale

Deaf Yoga

Tula Yoga & Wellness hosts this yoga class for individuals who are deaf or hard of hearing. Come learn the basic principles of letting go and meditation with a teacher that utilizes American Sign Language. Recommended minimum donation of $5. Contact the instructor at jessalyn@jessalynfrank.com for more information. Sunday, Dec. 21, 1–2 p.m., Tula Yoga & Wellness, 99 Snelling Ave. N., St. Paul

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Epilepsy Awareness Month November is National Epilepsy Awareness Month, focusing on raising awareness, increasing support, and funding research for new treatments for people living with this neurological condition. Those diagnosed with epilepsy have generally had at least one unprovoked seizure and are likely to have more. The seizures are not caused by any other treatable medical conditions and the cause remains unknown for six out of 10 people affected. Most people living with epilepsy have more than one type of seizure, and many experience other symptoms and neurological problems along with the seizures. Between 2.2 and 3 million in the U.S. have epilepsy, and 150,000 Americans are diagnosed with epilepsy each year. It is twice as common as cerebral palsy, muscular dystrophy, multiple sclerosis, and cystic fibrosis combined. There is no cure for epilepsy. While medications can treat the condition, about one-third of people who have this condition live with ongoing, uncontrollable seizures because none of the available treatments work for them.

Dec. 11

The Epilepsy Foundation of Minnesota offers this meeting to connect with other adults living with epilepsy. Come learn coping strategies, share personal experiences, and find support. Call (651) 287-2300 to RSVP or for more information. Thursday, Dec. 11, 6:30–8 p.m., Southdale Library, 7001 York Ave. S., Edina

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.

Adult Connect

Minnesota Health care news November/December 2014

Diabetes Insulin Pump Support Group

Fibromyalgia Support Group

HealthEast presents this free class for individuals interested in learning more about insulin pumps, as well as those already using one. Come learn about the potential challenges and benefits, and connect with others for support. Call (651) 232-6322 to sign up or for more information. Monday, Dec. 22, 6–7:30 p.m., Woodwinds Health Campus, Oak Conference Center, 1925 Woodwinds Dr., Woodbury

Allina Health hosts this free support group for those affected by fibromyalgia, chronic fatigue, and other chronic pain diseases. Come learn coping strategies, share resources, and connect with others dealing with pain, fatigue, sleep issues, and more. For more information, call Aimee at (651) 241-3373. Monday, Dec. 22, 6:30–8 p.m., Courage Kenny Rehabilitation Institute–St. Croix, Conference Rm. A, 1460 Curve Crest Rd., Stillwater

Jan. 3

Preparing for Your Child’s Orthopedic Surgery

Gillette Children’s Specialty Healthcare presents this free interactive session for parents to learn how to prepare for their child’s upcoming orthopedic surgery and what to expect during the procedure. Register by Dec. 27; call (651) 312-3198 or email preopclasses@ gillettechildrens.com. Saturday, Jan. 3, 1–3 p.m., Gillette Children’s Specialty Healthcare, Wallace Cole Conference Room, 205 University Ave. E., St. Paul

Health Insurance Counseling for Seniors

The Metropolitan Area Agency on Aging and Hennepin County Library host this free class. A certified state health insurance counselor will be on-site to assist with enrollment steps, plan choices, and determining low-income subsidies. Registration required; other dates are available. For more information or to RSVP, call (612) 543-8375. Wednesday, Jan. 7, 12:30–2 p.m. and 2–3:30 p.m., Washburn Library, 5244 Lyndale Ave. S., Minneapolis

Nonsteroidal anti-inflammatory drugs from page 17

}} blood thinners (such as warfarin or Coumadin) }} aspirin (daily or more often) Contraindications Individuals who are in any of the following categories should speak with their doctor before using any product that contains an NSAID. Heart problems (including stroke). People who have heart disease should speak with their doctor before taking NSAIDs because all NSAIDs except low-dose aspirin may worsen heart problems. It is unclear at what dose and at what point in treatment this drug class poses heart risks, but it is known that these medications can cause a slight increase in blood pressure. This effect may be greater in someone who already has high blood pressure, because NSAIDs can decrease the effectiveness of certain medications that lower blood pressure. One of the more serious threats that this drug class poses to heart health is that it increases fluid retention in heart failure patients. Another serious risk it poses to heart health is its ability to block the effects of antiplatelet medicines that help prevent heart attack and stroke in someone who has had the cardiac surgical procedure called coronary bypass graft (CABG). Consequently, patients who have heart failure or who have undergone CABG are generally instructed to avoid NSAIDs.

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Kidney problems. Check with your doctor before taking an OTC NSAID if you have chronic kidney disease. This drug class can cause decreased kidney function in people who have this chronic condition, thereby potentially worsening their already compromised kidneys. Pregnancy. Pregnant women should use NSAIDs with caution, and should avoid them completely during the third trimester. Use of these drugs is associated with increased complications during pregnancy and at the time of delivery. The future NSAIDs provide relief of many medical conditions to many people. However, this drug class currently presents the risk of stomach ulcers and that of several other side effects, so be sure to check with your pharmacist or health care provider before taking members of this drug class that are available OTC, such as ibuprofen. Current research is focused on developing NSAIDs that pose less risk of side effects, with the goal of making these useful medicines even better.

CHOL–2clr Amber Altstadt, PharmD; Bernadette Aragon, PharmD; and Katherine 211 530 Montag, PharmD, are pharmacy residents at Hennepin County Medical Center (HCMC), Minneapolis. Margaret McCann, RPh, BCPS, is a board-certified pharmacotherapy specialist who practices at HCMC. 02.04.14

Are you taking cholesterol medication but are looking for better control? Are you also at risk for cardiovascular disease (CVD)? If you are age 18 and older, take cholesterol medication, and also have risk factors for cardiovascular disease (high blood pressure, diabetes, overweight, smoking, family history of CVD), you may qualify for a clinical research study of an investigational cholesterol medication. Compensation up to $725 for time and travel may be available. Call for more information

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November/December 2014 Minnesota Health care news

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2014 health care architecture Honor roll

M Top: X-ray room Bottom: Children’s play area and reception area

innesota Physician Publishing’s 2014 Health Care Architecture Honor Roll recognizes outstanding projects completed since May 2013. This year’s Honor Roll projects include new clinics, hospital renovations, remodeled spaces, and facility expansions. Although the facilities differ in intended use and population served, they share a focus on providing a welcoming environment and cutting-edge technology. Recovery and therapy rooms have been designed to be bright, airy, and to offer patients comfort and privacy. Minnesota Physician Publishing thanks all those who participated in the 2014 Honor Roll.

Highland Park Clinic Type of facility: Outpatient clinic Location: St. Paul Client: HealthPartners Architect/Interior design: HGA Architects Contractor: Greiner Construction Completion Date: June 2013 Total Cost: $846,843 Square feet: 9,600 This project renovated an existing two-story space that is part of a strip mall. The 9,600-sq.-foot renovation took three months to complete. The

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 November/December 2014

main floor of this high-end clinic houses a reception area, adult waiting room, pediatric play area, procedure rooms, and care team stations equipped with computers. The lower level of the facility houses X-ray equipment, the X-ray control room, and a blood draw area. Greiner Construction coordinated a thirdparty inspection to ensure the structure could support the weight of the X-ray equipment. Also on the lower level are dressing rooms, an employee break room, offices, restrooms, storage, and an area for IT, mechanical equipment, and the boiler.

Summit Orthopedics Type of facility: Medical office building Location: Vadnais Heights Client: Summit Orthopedics Architect/Interior design: Pope Architects Contractor: RJM Construction Completion Date: February 2014 Total Cost: $8,877,316 Square feet: 66,346 Summit Orthopedics consolidated three locations— Maplewood, Maplewood Therapy, and Vadnais Heights—into a single-specialty advanced center for orthopedics in Vadnais Heights. Located on the corner of 35E and County Road E, the new location offers north metro residents the full continuum of orthopedic care and treatment.

Top: Waiting area Bottom: Patient room

The 66,346-sq.-foot build-out includes recovery areas, a surgery suite, physical therapy space, and clinic space. Pope Architects was the programmer, interior designer, and interior architect. Pope worked collaboratively with the developer, MSP Commercial, and the core and shell architect, Genesis Architects. RJM Construction completed the interiors within an expedited schedule and collaborated with the shell building contractor, Welsh Construction, to start tenant finishes early, meeting the owner’s needs. The completed medical office building features contemporary finishes, a reception space, and recovery areas reminiscent of a hotel room.

Autism Day Treatment (ages 2–6)

Pediatric Therapies (ages 2–12) Speech • Feeding • Occupational

Children’s Mental Health Services (ages 2–21) Autism Support Services (ages 2–26)

Your resource for every child. Therapeutic Recreation (ages 11+) After-School • Release Days Summer • Weekends

Personal Care Assistance, Supported Living & Waivered Services

PUT THE SQUEEZE ON HIGH BLOOD PRESSURE If you have diabetes, controlling your blood pressure can help protect you from heart attack, stroke, blindness and kidney disease

• Track your blood pressure and share with your doctor • Medicines can make a difference... if you take them • Eat healthy and be active • Avoid salt • Do not smoke

Minnesota Diabetes & Heart Health Collaborative

The Minnesota Diabetes and Heart Health Collaborative: Working together to keep you informed

952.548.8700 • www.stdavidscenter.org 3395 Plymouth Road, Minnetonka

www.mn-dc.org Adapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard November/December 2014 Minnesota Health care news

Honor roll 2014

Left: Waiting area Right: Reception

PrairieCare Chaska Type of facility: Outpatient clinic and partial hospital program Location: Chaska Client: PrairieCare, LLC Architect/Interior design: Pope Architects Contractor: RJ Ryan Construction Completion Date: March 2014 Total Cost: $1,100,000 Square feet: 18,000 PrairieCare Chaska provides outpatient psychiatric services for all ages. PrairieCare began discussions with Ridgeview Medical Center in early 2013 about bringing specialty psychiatric services to Two Twelve Medical Center. The new clinic has an art therapy room in

Minnesota Health care news November/December 2014

which kids can use art to express their feelings. A state-of-the-art patient care station allows close patient monitoring and streamlines staff communication. A break room accommodates gross motor skill activities and also acts as a cafeteria. PrairieCare incorporates multidisciplinary evidence-based treatment including: psychiatry, psychology, psychotherapy, and complementary alternative medicine. Its Partial Hospital Program (PHP) is a state-of-the-art therapeutic environment optimally conducive for psychiatric assessment and crisis stabilization through intensive psychiatric intervention, therapy, and educational services. PHP provides the same clinical programming as 24/7 inpatient hospitalization, but provides it Mâ&#x20AC;&#x201C;F 9 AMâ&#x20AC;&#x201C;4 PM. The fourth of five sites within the PrairieCare psychiatric health system, this will provide intensive psychiatric care to 600 youth each year, as well as thousands more patients in the clinic.

Left and right: Reception area detail Right: Reception

Park Nicollet Women’s Center Type of facility: Outpatient clinic Location: St. Louis Park Client: Park Nicollet/HealthPartners Architect/Interior design: AECOM Contractor: Mortenson Construction Completion Date: April 2014 Total Cost: $4,900,000 Square feet: 27,000 Park Nicollet’s new outpatient Women’s Center consolidates more than 15 preventive and specialty services into one location on the top floor of Methodist Hospital’s existing Heart and Vascular Center. The center was designed to support comprehensive health services for women of all ages in a convenient, comfortable environment. Upon entering the floor, patients are greeted by a spa-like atmosphere. Services such as aromatherapy, massage, and plush robes

are offered to enhance wellness and reduce stress. Access to daylight is maximized and the use of natural materials, artwork, and decorative lighting presents a contemporary image of wellness. Flexible space for group visits and education classes have been integrated into the design. The new space employs multiple innovative features, such as iPads, to anticipate the needs and perspectives of patients of various generations. Care-team neighborhoods facilitate self-rooming and reduce travel distances for staff. On-stage and off-stage circulation enhance the patient experience and maximize privacy. Flexibility of the space is increased through the use of hoteling exam rooms, demountable partitions, and systems furniture. Integrated, state-of-the-art technologies support wireless staff communication as well as patient engagement.

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November/December 2014 Minnesota Health care news

L e g i s l at i o n

2015 Health and Human Services legislative preview

What to expect By Rep. Tina Liebling and Matthew Bergeron, JD

hen Minnesota’s 89th legislature is sworn in this January, the legislators serving on the Health and Human Services (HHS) Finance and Policy committees will again take on some of the most complex and impactful issues of the new session. The post-election political dynamics and the economic MSA - MN Healthcare July 2013.pdf 1 6/12/13 15:23 realities presented in the November budget forecast will undoubt-

edly color the tenor and direction of the committee agendas. What’s more, Finance will be under new leadership for the first time in nearly a decade as both Rep. Tom Huntley (DFL–Duluth) and Rep. Jim Abeler (R–Anoka) will have retired. The committee chair largely determines which issues and bills the committee will hear. Moreover, his or her priorities leave a strong imprint on all HHS legislation that reaches the governor’s desk. But no matter who chairs and who serves on that committee, certain topics are likely to be considered by Health and Human Services Finance and/or Policy committees and may be included in the fiscal year 2016–2017 health and human services budget bill. Three of these topics are: reform of Minnesota’s child protection system, efforts to address solvency issues with Minnesota’s Health Care Access Fund, and the state’s attempt to address a future shortage of health care professionals. Child protection reform In early October, Gov. Dayton responded to a troubling series of news reports detailing tragic failures in the county-based and state-supervised child protection system. The governor established a Child Abuse Task Force and appointed Department of Human Services Commissioner Lucinda Jesson and Ramsey County Commissioner Toni Carter as co-chairs. He charged the task force with a comprehensive review of the child protection system and gave it a short timeline within which to make policy and budget recommendations to the legislature for the 2015 session. The task force likely will address the impact of past cuts to the Children and Community Services Act Fund, including the approximately $11 million cut (a 15 percent reduction) that was part of the agreement that ended the 2011 government shutdown. With bipartisan support and membership from a broad range of stakeholders which includes the Department of Human Services, county social services, the courts, tribes, and child protection advocates, the recommendations of this task force likely will affect the work of the Health and Human Services Policy and Finance committees.

Minnesota Health care news NoveMber/December 2014

Minnesota’s health-care access fund From a budgetary standpoint, perhaps the largest issue facing the Health and Human Services committees is the financial solvency of Minnesota’s Health Care Access Fund. Created in 1992 as a funding mechanism for MinnesotaCare, the state’s low-income health insurance program, the fund faces a projected deficit in the 2016– 2017 biennium as well as a long-term funding problem beginning with the 2018–2019 budget. According to a post-2014 legislative session update by Minnesota Management and Budget, the Health Care Access Fund deficit is forecast to be approximately $94 million in 2016 and $239 million in 2017.

expansion and the prohibition on insurance denials for preexisting conditions, tens of thousands of Minnesotans now have access to health insurance that covers primary care services. However, rural areas are particularly prone to shortages of primary health care and Minnesota as a whole lacks the primary care providers needed to maintain a nation-leading health care system.

The governor established a Child Abuse Task Force.

Much of the projected shortfall is a result of Minnesota’s success in keeping the cost of health insurance in check. Under the Affordable Care Act, states have the opportunity to create what are called Basic Health Programs (BHP) to provide coverage for people whose incomes are less than 200 percent of the federal poverty level but greater than 138 percent of the federal poverty level, which is the Medicaid threshold. Minnesota is one of only two states poised to launch a BHP after having made changes to the MinnesotaCare program—such as eliminating the $10,000 hospital cap—in order to get the existing program to qualify for federal BHP funding. Unfortunately for Minnesota, the federal regulations regarding BHP funding use health insurance exchange rates as a baseline. MNsure, Minnesota’s state health insurance exchange, offers the lowest premiums in the nation so these regulations result in a lower federal contribution than initially forecast. The legislature will have to determine how to close that combined $333 million deficit this year. The Health Care Access Fund’s solvency issues are expected to worsen substantially in the FY 2018–2019 biennium because the 2 percent tax on health care providers that funds the majority of MinnesotaCare is scheduled to expire Dec. 31, 2019. This expiration, sometimes referred to as “sunset,” is a holdover from the agreement that ended Minnesota’s 2011 government shutdown. The sunset of Minnesota’s provider tax would leave the legislature with the difficult task of replacing well over $1 billion in annual health care funding, or cutting this program that is designed to provide affordable health insurance to low-income working Minnesotans. Health-care workforce issues Ensuring that all Minnesotans can get affordable health insurance is a great achievement but it means little without access to health care. Minnesota, like other states, needs enough primary care providers to treat its population. However, as our population grows and ages, the health care workforce is also aging and many providers are now retiring. The health care workforce already is struggling to keep up with demand. In 2011, the Governor’s Workforce Development Council estimated that between 2000 and 2030, the portion of Minnesota’s population that is 65 and older is expected to increase from 12 percent to 24 percent. This will stress our health care system even further, because people usually need more health care services as they age. The stresses on the system are compounded by the nearly 40 percent reduction in Minnesota’s uninsured population since the implementation of the Affordable Care Act. As a result of the Medicaid

In 2014, the legislature created the Health Care Workforce Commission to examine shortages, evaluate the effectiveness of current incentive programs such as medical school loan forgiveness, and propose new strategies to address the problem. With the commission’s first report due in December 2014, the legislature will have proposals to consider as it strategizes how to bolster the state’s health care workforce. Plenty of work ahead These are just three of the pressing health and human services issues that will be discussed this session. There will be many more. Minnesota’s health and human services budget makes up nearly 30 percent of all General Fund expenditures. With that much money involved and that many lives affected, there is plenty of work ahead to build a healthier state. Tina Liebling, (DFL-Rochester), Chair, Health and Human Services Policy Committee, has served in the Minnesota House of Representatives since January 2005. Matthew Bergeron, JD, is Committee Administrator, Health & Human Services Policy and the Select Committee on Living Wage Jobs, Minnesota House of Representatives.

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NoveMber/December 2014 Minnesota Health care news

Oncology

Staging cancer What it means; how it’s used By Noel Laudi MD, MRCP

hen patients learn they have cancer, one of the most common questions they ask is, “What stage is my cancer?” The “stage” of a cancer is a way to express whether it has spread to other places in the body, and knowing that helps an oncologist (a doctor that treats cancer) determine a treatment plan. If the cancer is limited to one area, surgery and/or radiation therapy are often indicated. If, on the other hand, the cancer has spread to other places in the body, then treatment most likely would include

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Once a cancer is diagnosed, further tests are usually indicated to complete the staging. These might include lab tests and/or X-ray tests such as an MRI, CT scan, and PET scan. These scans take pictures of the interior of the body to help determine whether and/or where the cancer has spread. Staging is a very important part of the evaluation before surgery for most cancers. Breast cancer One exception to using scans for staging is breast cancer. Since the widespread adoption of regular mammograms, breast cancer increasingly is being diagnosed early enough that information about whether the cancer has spread can be obtained without using scans. Information is obtained instead by examining the lymph nodes next to the affected breast. This has the advantage of not exposing the woman to the radiation involved in a scan. This is how staging breast cancer is done. If a breast biopsy confirms cancer, the patient undergoes removal of the tumor (the cancerous area of tissue), followed by sampling the lymph nodes in the armpit next to the affected breast. If cancer is detected in these nodes, it means the cancer is at a higher stage. This helps the doctor figure out the best treatment, since breast cancer at a higher stage may require more treatment after breast-removal surgery than a lower stage breast cancer. The additional treatment may include chemotherapy and radiation therapy. CT or PET scans are not typically part of the evaluation prior to breast cancer surgery unless there is concern that the cancer has already spread.

Jeffrey Mil ler, MD, and Timothy Schacker, MD

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chemotherapy as well. In addition to helping to plan treatment, the stage of a cancer also suggests its prognosis.

Minnesota Health care news November/December 2014

Most other cancers However, most other cancers do require staging scans before surgery. That’s because surgery to remove certain tumors can be done only if the tumor has not spread to other parts of the body. This is due to the fact that removing the primary cancer without addressing the areas to which it has spread would not change the outcome and therefore surgery would be futile. If scans do not show

signs of spread, the patient receives surgery to remove the tumor, which reduces the risk of the cancer coming back. Lymph nodes Sampling lymph nodes at the time of surgery is another key element in determining the stage of the cancer. Involvement of lymph nodes contributes not only to the stage of the cancer, but also gives us a sense of the risk of the cancer coming back in the future. For cancers of the colon, lung, prostate, breast, ovary, and uterus, evaluating the lymph nodes for cancer is a key part of surgery. Removing cancerous lymph nodes also may help reduce the risk of the cancer recurring. Main factors

The stage of a cancer is based upon three factors: size, whether it has spread to the lymph nodes, and whether/ how much it has spread to sites other than lymph nodes.

such marker is prostate-specific antigen, or PSA, which is used to screen for prostate cancer. Another marker, carcinoembryonic antigen (CEA), is used routinely to monitor for recurrence of colon cancer after the colon tumor has been removed. In testicular cancer, tumor markers play a key role in determining the stage of disease and treatment of the patient. Conclusion

Even if a cancer is stage IV, there are many treatments available not only to help improve symptoms but also to get the tumor in remission. (We say a cancer is “in remission” when there are no signs of cancer detected on scans or on physical examination). For stage IV cancers that are chemotherapy-sensitive, such as lymphomas and testicular cancer, cure is very likely even if the disease has spread. Stage IV colon cancer is another cancer that can be potentially cured with surgery and chemotherapy if the disease has not spread very far.

The stage of a cancer suggests its prognosis.

Tumor size. The size of the primary tumor is designated “T” and usually is measured in centimeters. T1 is the smallest size of a tumor; T4, the biggest. T4 usually refers to either a very large tumor or indicates that the tumor has invaded nearby tissues. Lymph nodes. N stands for “lymph nodes status,” indicating whether the cancer has spread to nearby lymph nodes. It typically ranges from N1 to N3. The higher the N number, the more lymph nodes there are that contain cancer. Metastasis. M stands for “metastasis.” It tells whether the cancer has spread to distant parts of the body other than lymph nodes. M0 means it has not spread; M1 means it has spread to at least one distant organ. The overall stage of a cancer is derived from the combined values of T, N, and M. The stage is a Roman numeral from I to IV, where stage I is the earliest stage and often associated with an excellent prognosis. As the stage number increases, the cancer becomes more advanced. This may mean that a tumor may be bigger, has spread to surrounding lymph nodes, or is more widespread. One important exception is head and neck cancer, for which “stage IV” does not necessarily mean that the cancer has spread to distant areas of the body. Other factors

Grade. For some cancers, treatment decisions and prognosis also depend on the “grade” of the cancer. This refers to the appearance of the tumor cells under the microscope. The more abnormal the cells look, the faster they tend to grow and spread. The grade is usually assigned a number from 1 to 3. Higher-grade cancers (meaning that the cancer cells look very different from normal cells) tend to be more aggressive. For example, a small grade III tumor might require more intense therapy than a larger grade I tumor. Tumor markers. Another important factor in determining stage is the presence or absence of tumor markers. These are chemicals released by certain cancers, and can be detected in the blood. One

Remember: A diagnosis of stage IV cancer does not automatically mean the end. Noel Laudi MD, MRCP, is board-certified in oncology and hematology and practices with Minnesota Oncology Hematology, PA.

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Insurance

Inpatient or observation? Avoiding sticker shock after a hospital stay By Will Phillips

facility once an enrollee has spent three days admitted to the hospital as an inpatient. In this case, however, and without the family’s knowledge, her father’s first two days at the hospital were classified as “observation status” by the hospital.

Naturally, she’s shocked, because Medicare normally covers the entire cost of the first 20 days of rehabilitation at a skilled care

A patient held under observation status is considered to be an outpatient, not one who has been admitted to a hospital as an inpatient. Since observation status doesn’t count toward the Medicare requirement of three days as an admitted patient, the cost of weeks of skilled rehabilitation care for your coworker’s father is now his or his family’s responsibility, not Medicare’s.

ou’re in a meeting with a coworker when her phone rings: Her elderly father has had a bad fall and is on the way to the emergency room. At the hospital, she discovers that her father will need to stay in the hospital. Four days later, her father is moved to a skilled rehabilitation care facility for several weeks of physical therapy. After therapy is complete and her father returns home, your coworker receives a bill for thousands of dollars for the entire cost of her father’s stay in the rehabilitation facility.

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Widespread problem This scenario happens frequently in Minnesota and nationwide, and is a rapidly growing problem for seniors. While observation status is primarily a problem for people on Medicare, it also can affect others whose insurance reimburses differently for outpatient care than for inpatient care. There may be no difference between the room or care a patient receives whether admitted as an inpatient or classified as an outpatient by virtue of being under observation status. However, this difference in hospital status can mean a big difference in the size of the patient’s bill. Fortunately, there is a solution, and that is to ask questions of a hospital while you or your loved one is staying in it. Read on to find out what you should ask your hospital, and how the need for questions arose.

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What’s causing this problem? The root of the problem dates to 1965, when Medicare was created. Back then, the average length of time a senior spent in the hospital was 13 days, so meeting the three-day requirement was fairly easy and essentially a mere formality. However, as of 2010, the average length of stay was 5.4 days, with more than one-third of all seniors hospitalized for fewer than the required three days. At the same time as lengths of stays are dropping, the use of observation status is skyrocketing. According to a recent AARP study, the number of people classified under observation status more than doubled between 2001 and 2009.

Minnesota Health care news November/December 2014

One driver of the trend for hospital patients to be classified under observation status may be that hospitals have begun being penalized if a patient is readmitted as an inpatient within 30 days of being discharged from the hospital. Hospitals’ desire to avoid penalties may lead them to classify someone under observation status.

at a time when hospital stays were much longer. These days, when one-third of all Medicare hospital stays are less than three days, the rule has become a barrier to care. The result is that patients are either ill-informed and wind up with large bills, or they choose to forego follow-up care they need but can’t afford.

Effects on hospitals, patients While studies have shown that the use of observation status can increase hospital efficiency, any increase in efficiency disappears once a patient has been under that status for 12 to 24 hours. Research by AARP found that between 2001 and 2009, there was a 250 percent increase nationwide in observation stays lasting 48 hours or longer.

Short of ending the three-day rule, Medicare should stop making distinctions between observation and inpatient stays. If the type of care is the same for the patient, doctor, and hospital, it should be viewed the same by Medicare. Bipartisan legislation has been introduced in Congress (HR 1179/ S. 569) to count time spent in observation status toward Medicare’s three-day requirement for coverage.

A difference in hospital status can mean a big difference in the size of the patient’s bill.

The effect on patients is that every day a patient is held under observation status, i.e., as an outpatient, his or her care is covered by Medicare Part B instead of Part A. Unlike Part A, which covers all costs, Part B charges the patient out of pocket for copays and prescription drugs. Steps to take For financial protection, a patient and his or her family should ask:

Protect yourself The best option for patients and their families is to stay informed during a hospital stay and to ask questions. If you are in the hospital, ask how long your stay will be, what type of rehabilitation options are available to you, and who pays for them. And be sure to ask what your hospital status is—inpatient or observation—every day that you or a loved one is in the hospital.

• How long will the hospital stay last? • Will there be a need for skilled care after the patient is discharged?

Will Phillips is the state director of the Minnesota branch of AARP, and has worked with AARP in various capacities for more than nine years.

• What is the patient’s status? Is it “inpatient” or “observation”? Patients and their families should ask these questions the first day they arrive at the hospital and every day thereafter. That’s because a hospital can change someone’s status from one day to the next, during the same day, and even retroactively after a patient is initially admitted as an inpatient.

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It is also important for patients and their families to understand they have the right to appeal the hospital’s decision. If they know skilled care is needed and find out that a portion of their stay is being counted as observation, they can request that the status be changed to inpatient. If the patient or family doesn’t feel comfortable making that request, they can enlist the patient’s primary doctor, the hospital’s patient advocate, or a hospital social worker to ask on the patient’s behalf. All patients have rights, but they must be willing to exercise them. Hospitals aren’t required to disclose whether a patient was under inpatient or observation status until the patient is discharged, so asking questions up front is essential. It is much easier to appeal a hospital’s decision while your loved one is still in the hospital than it is to appeal to Medicare after the bill arrives.

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Long-term solution needed While asking questions is important, the reality is that most families whose loved one is in the hospital are distracted by medical concerns and aren’t going to be thinking about hospital status. If we really want to protect patients, Medicare’s outdated threeday rule should be eliminated. It was meant to be a basic threshold November/December 2014 Minnesota Health care news

ta k e c a r e

Over-thecounter testing Know the limitations By Kurt Angstman, MD

lthough over-the-counter (OTC) testing has been present for many years, over the last two decades there has been an explosion in the number of OTC medical test kits available. The potential benefits of this include privacy, enhanced self-management of one’s health, and cost-savings.

For example, pregnancy and ovulation tests allow a patient the privacy of testing and getting the result at home. OTC testing via glucose meters that assess blood for its sugar content provide diabetics with information about their health status more frequently and conveniently than would be available through routine office visits,

Accidental Bowel Leakage (ABL) You no longer need to suffer in silence Nearly 18 million U.S. adults, or one in twelve, are affected by ABL. Men and women of all ages may be affected, although it is more common in older adults. Most people and many physicians are not aware of the reasons for ABL or that it can be easily treated. In addition, fear, shame and embarrassment are often impediments to seeking solutions to this problem. We specialize in diagnosis and treatment of ABL. Modern medicine brings an array of simple, safe and effective procedures to treat ABL. At the Pelvic Floor Center we provide a multi-disciplinary approach for the treatment of ABL and other pelvic floor disorders including urinary incontinence and pelvic prolapse. • Dietary modification • Biofeedback therapy • Office – based procedures We see patients on referral. If you are experiencing ABL your primary physician can refer you to the Pelvic Floor Center or you can see a provider at Colon and Rectal Surgery Associates for initial evaluation and referral.

651.225.7800 • www.pelvicfloorcenter.org For information about other services we provide please visit us at www.colonrectal.org 30

Minnesota Health care news November/December 2014

which helps them manage their condition. Finally, OTC tests allow a patient with limited access to health care to obtain some desired testing results without having to bear the additional financial costs of accessing the health care system, such as public transportation and copays. But, with these benefits come limitations. Knowing the limits of OTC testing will help you use it wisely. Types of tests Some tests are better at detecting a given condition, and other tests are better at ruling out a condition, but basically, there are two types of OTC tests. One type produces results at home, with the person who performs the test being responsible for determining the result. An example of this is a home pregnancy test. The other type requires someone to collect a bodily sample and mail it to a lab for testing. This type of test requires the person being tested to wait for results to become available online; to arrive in the mail from the lab; or to be delivered to the person’s physician, who subsequently shares it with the person who collected the sample. An example of this is DNA testing, available from at least one testing company, which posts results to what the company says is a secure website. Among the many OTC tests available are those that test for the level of anticoagulation (thinning of the blood) in people taking blood-thinning medication; the virus that causes AIDS; cholesterol and triglycerides; and blood in the stool (a possible symptom of colon cancer). There is even a test allowing breastfeeding mothers to screen for the presence of alcohol in their milk. Since children should not be exposed to alcohol, this test allows a breastfeeding mother who has consumed alcohol to know if she can safely nurse her child or if she should provide the child with an alternative source of nutrition until alcohol has passed from her system and is no longer detected by the test.

negative. An example of this would be OTC screening tests for colon cancer. These are typically so-called fecal occult blood tests, which are designed to detect blood in the stool. Blood in the stool indicates the need for further investigation into why the blood is there, since it can indicate the presence of colon cancer. However, a positive result from this particular test (i.e., blood in the stool) does not necessarily indicate the presence of colon cancer. There are medical conditions besides cancer that may cause blood to be in stool, such as hemorrhoids or inflammatory bowel disease. There are also nonmedical conditions that may produce a falsely positive test, including certain dietary changes. The drawback to having a false positive result from this particular test is that it could lead to a colonoscopy, which may or may not be necessary. And since a colonoscopy involves a small but real risk of serious complication, it presents an unnecessary risk to a patient who doesn’t need it. False negative result A false negative result from OTC colon cancer screening may be caused by chance (not all cancers cause bleeding every day) or inappropriate use of the test equipment. A false negative result means that the patient really did have colon cancer. The danger in this situation is that because the test was negative, the person who self-administered it and interpreted the results without consulting a physician did not seek a follow-up colonoscopy that would have detected the colon cancer. This could lead to a cancer becoming advanced before being detected, which would decrease the chances for survival Over-the-counter testing to page 32

In the next issue...

More recent entries into the OTC market are kits that claim to establish paternity, i.e., identify someone as the father of a specific child. Interpreting results “Claim” to provide is key to understanding one of OTC testing’s drawbacks, because no test is foolproof, whether it’s conducted in the doctor’s office or in someone’s home. For example, no OTC paternity test can say with 100 percent certainty that a specific man fathered a specific child. Accuracy In addition, part of the medical community’s concern about OTC testing is the interpretation of test results. There are several reasons for concern. One is that people doing the testing generally are not trained health professionals and hence may not recognize if they have other symptoms that influence the interpretation of their OTC test results. False positive result Plus, the results themselves may not be straightforward. That’s because any test may produce a result that is falsely positive or falsely

• Peripheral artery disease • Long-term care access • Respiratory therapy November/December 2014 Minnesota Health care news

Over-the-counter testing from page 31

and could lead to the person dying of what initially was a treatable condition, had it been detected by colonoscopy. Clinical context Correct interpretation of results involves determining clinical context. Consider OTC home pregnancy tests, for example. Most home pregnancy tests are very sensitive, so if the test is positive there may not be a reason to confirm the pregnancy with a visit to a health care provider’s office. However, if there is concern about a possible miscarriage, a physician may order a blood test to measure the level of a hormone that can help the physician determine whether the pregnancy is remaining healthy. In this situation, the urine home test gives a yes/no answer, but may not indicate the health of the pregnancy, which is assessed by the results of the blood test. Some OTC tests are vital for monitoring certain chronic health conditions such as diabetes. Many patients with diabetes, for example, monitor their blood sugar level multiple times throughout the day using OTC means and adjust their treatment based on the results, according to the plan of care provided by their clinician. In these situations, the clinical context, the patient’s interpretation

of OTC test results, and the coordination of care all work together with the ease of OTC testing to maintain the patient’s health. Keep your doctor in the loop The goal of any test, whether it’s conducted in a medical office or someone’s home, is an accurate result. Sometimes, the test result you seek is a straightforward ‘yes,’ ‘no,’ or number: “Did I ovulate this month?” “Am I pregnant?” “What is my blood sugar level?” OTC kits’ answers to such questions may produce answers that indicate well-defined next steps.

Knowing the limits of OTC testing will help you use it wisely.

However, OTC test results, just like those obtained in a health care setting, may need to be interpreted based on what type of test was done and the context of the test-taker’s personal health history. This is where you may need and benefit from the expertise of your health care provider. Physicians are here to help you get the greatest benefit from your OTC tests, so be sure to keep your doctors informed of your OTC results.

Kurt Angstman, MD, is board-certified in family medicine, the current president of the Minnesota Academy of Family Physicians, and an associate professor in the Department of Family Medicine, Mayo Medical School.

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 results of the most recent survey.

30 25 20 15 10 5 0

Strongly agree

Agree

No Disagree Strongly opinion disagree

40 35 30 25 20 15 10 5 0

Strongly agree

Agree

No Disagree Strongly opinion disagree

30 25 20 15 10 5 0

Strongly agree

Agree

No Disagree Strongly opinion disagree

5. I am willing to spend more money on food that is healthier. Percentage of total responses

Percentage of total responses

4. It is important to me to know where the food I purchase came from.

50 40 30 20 10 0

Strongly agree

Agree

Minnesota Health care news November/December 2014

No Disagree Strongly opinion disagree

3. It is important to me to purchase food that specifically identifies no “Genetically Modified Organism” (GMO) content. Percentage of total responses

2. It is important to me to eat fruits and vegetables that have been raised organically. Percentage of total responses

Percentage of total responses

1. It is important to me to purchase meat that has been raised without antibiotics.

30 25 20 15 10 5 0

Strongly agree

Agree

No Disagree Strongly opinion disagree

Minnesota

Health Care Consumer Association

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

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

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Join now.

â&#x20AC;&#x153;A way for you to make a differenceâ&#x20AC;? November/December 2014 Minnesota Health care news 33 NOVEMBER 2012 MINNESOTA HEALTH CARE NEWS 33

Empower yourself from page 13

A MAPS advisory committee of experts identified these as four particularly important things patients can do to reduce patient safety problems during medical transitions. Patient safety tools The beauty of the to-do list is that patients only need a pen, paper, and file folder in order to accomplish the list. But just to make the point about how important these to-dos are, MAPS is currently piloting the use of patient safety packets that are given to patients at health care appointments.

to accomplish the four to-dos. A patient can use their smartphone to take a photo of a medication bottle and test result, and place those images in an app-based list that can be shared with caregivers in the future. Patients will be able to add items to the app-based list by typing or by dictating using voice recognition software built into the app.

Serious patient harm can occur during transitions between stages of care.

Empowering patients These materials have only just begun to be available to patients, so it’s too early to report how effective they are. Website usage, a web-based survey, and feedback from patients and health care providers will be monitored closely to learn how this campaign can be improved.

Rather than just tell patients how important the patient safety to-dos are, the packets show people how to accomplish the to-dos. These packets include a paper tablet, pen, expandable folder, and a refrigerator magnet that reminds them about the to-dos. The packets also include a one-page flyer that describes why these steps are so important, and a link to MAPS’ website for those who want a more detailed explanation that includes a video.

But we have a hunch that fitting a patient’s to-do list onto a refrigerator magnet instead of into 70 pages of discharge instructions is a good first step. We hope that ultimately, empowering patients will help reduce the unacceptable human and financial costs of communication breakdown during medical transitions.

For people inclined to use technology, a smartphone app is available through our website. It offers the option of using a smartphone

Marie Dotseth is the executive director of MAPS, whose members include health care providers statewide, consumers, state regulators, and state agencies. A full list of MAPS members can be found at www.mnpatientsafety.org

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

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Minnesota Health care news November/December 2014

S:9.75”

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

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for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Add-on to Metformin Victoza® + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Add-on to Glimepiride Victoza® + Rosiglitazone + Placebo + 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 ® + Metformin + Placebo + Metformin + Rosiglitazone All Victoza 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