Your Guide to Consumer Information May/June 2017
Joint replacement surgery By Dane Hansen, DO
Clinical lab work By William Morice, II, MD, PhD
Psychiatric medications By Marie Casey Olseth, MD
Vol. 15 No. 5
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MINNESOTA HEALTH CARE ROUNDTABLE
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Prescription drug prices skyrocket: Bipartisan legislative solutions Senator Amy Klobuchar, JD
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Reference laboratories William Morice, II, MD, PhD
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Joint replacement surgery: Helping maintain a healthy lifestyle By Dane Hansen, DO
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Psychiatric medications: Understanding how they work By Marie Casey Olseth, MD
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Recognizing Minnesota’s Volunteer Physicians By Lisa McGowan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Political divisiveness in health care: Learning to work together By Ed Weisbart, MD
Thursday, November 2, 2017 • 1-4 PM
Symphony Room III, Downtown Minneapolis Hilton and Towers
BACKGROUND AND FOCUS:
Dry eye disease: Symptoms, causes, and treatments By Michael V. Dieter, OD
HEALTH CARE POLICY
Efficacy, Economics, and Evolution
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Reducing health disparities: Data is the key By Jim Chase, MHA, and Anne Snowden, MPH, CPHQ
Several recent studies have reached troubling conclusions. A huge percentage of prescription medications produce little to no therapeutic benefit for many patients. In large part this relates to a drug development paradigm and medical care model centered more on treating symptoms than curing root causes. An emerging solution to this problem is the field of regenerative medicine—an approach that directly repairs or replaces damaged tissues and organs. Though initial research and development costs present significant upfront investment, the promise of better outcomes and eventual savings are impossible to ignore.
We will define regenerative medicine and trace its development. We will explore what the pharmaceutical, device, and insurance industries are doing now with regenerative medicine and how they can work together moving forward. We will discuss the challenges that face regenerative medicine and offer potential solutions. We will look ahead so that, as we enter the third decade of the 21st century, the pace of innovation can expand in a way that is accessible, affordable, and sustainable. Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 7288600, 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
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MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Most Major Heart Attacks Occur in Patients with Normal Cholesterol
The study was published April 12 in 2013. Before the new guidelines, physicians would typically check a in the Journal of the American Heart patient’s cholesterol levels and put Association. them on medication if those levels Results of a Minneapolis Heart were elevated. Opioid-Related Deaths Institute study have shown that most “The more recent cholesterol patients who have suffered major guidelines are clearly a big step in the Rose Significantly in 2016 heart attacks had normal cholesterol right direction, but we need to have There were 153 opioid-related levels. In addition, more than half of better systems and incentives in place deaths in Hennepin County in 2016, acthese patients had not seen a physi- to get patients the assessment and cording to the Hennepin County Shercian in the two years prior to their treatments that could potentially be iff’s Office. That’s a 39 percent increase heart attacks. from 110 opioid-related deaths in 2015. life-saving,” said Miedema. “The data on statins clearly shows that individuals with normal cholesterol levels can also reduce their risk of heart attacks,” said Michael Miedema, MD, MPH, cardiologist at Minneapolis Heart Institute and principal investigator for the study. Researchers reviewed data, cholesterol values, and prior medical encounters for more than 1,000 patients who were treated for STEMI heart attacks, a serious form of heart attack in which a coronary artery is completely blocked, between Jan. 1, 2011 and Dec. 31, 2014. They also looked at new treatment guidelines for heart disease that were established
Researchers found that for this group of heart attack patients, 39 percent would have qualified for a statin medication prior to their heart attack according to the old guidelines whereas 79 percent were statin eligible according to the new guidelines. Now, physicians also look at factors such as age, gender, and high blood pressure.
“Every one of the 153 deaths was tragic and every one was preventable,” said Rich Stanek, Hennepin County Sheriff. “In response to this crisis, we will work together to build strong partnerships to reduce the number of opioid related deaths.”
The statistics were announced at the first meeting of the #NOverdose “Heart disease is a multifactorial coalition, a new initiative to address process, and factors other than cho- the growing opioid epidemic. The lesterol, like smoking or high blood meeting included law enforcement pressure, can raise your risk even if agencies, school districts, medical your cholesterol is normal,” said Mie- professionals, community organizadema. “In fact, we found that the av- tions, and community members. They erage cholesterol levels in this group discussed recommendations for educating youth and parents, new ideas of individuals were quite average.”
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
for prevention messaging, and ways for coalition members to get involved. The data also showed that there have been six opioid-related deaths in the first two months of 2017.
Residential Treatment Program to Open in Fridley Allina Health, Anoka County, and Touchstone Mental Health are collaborating to launch a new residential treatment program for people managing health conditions near Mercy Hospital–Unity Campus in Fridley. The partnership aims to address an ongoing shortage of psychiatric beds across the state and will serve 16 people daily and about 85 people annually. The program is designed to complement the mental health and addiction services provided at Mercy Hospital–Unity Campus. It will provide 24/7 mental health support for patients who are transitioning from hospitals and those who require stabilization in order to prevent hospitalization. Short-term housing will
be available for up to 90 days, with extensions for patients who need further treatment. During the stay, they will receive counseling, medication management, and education on independent living skills to increase their chances of success after they leave. Those who have substance abuse issues along with mental health issues will receive integrated treatment.
Second Opinions Valuable for Many Patients
site treatment director, mental health professionals, nurses, practitioners, counselors, and peer specialists. Patients who are being discharged will receive planning and assistance in finding housing and community services to continue to meet their needs.
According to Mayo Clinic, obstacles to patients receiving second opinions may include health insurers limiting access to care outside their network to manage costs; primary care providers being more confident in their diagnostic expertise than was warranted in particular cases; and patients lacking the knowledge or assertiveness to request a referral.
As many as 88 percent of patients who visit Mayo Clinic for a second opinion or diagnosis confirmation before treatment for a complex condition leave with a new or refined diagnosis, according to results of a Mayo Clinic study. Only 12 percent “Residential treatment programs receive confirmation that the original are an important strategy for helping diagnosis was complete and correct. people manage complex mental health Researchers examined records for needs,” said Ruth Engelstad, chair 286 patients who were referred by priof the Anoka County Adult Mental mary care providers to Mayo Clinic’s Health Advisory Committee. “Touch- General Internal Medicine Division stone will be able to provide the pro- in Rochester over a two-year period fessional level of support needed to from Jan. 1, 2009 to Dec. 31, 2010. transition individuals through their They compared the referring diagnocare, just like what is done for people sis to the final diagnosis to determine with knee and hip replacements.” the level of consistency between the Anoka County selected Touch- two and to find the level of diagnosis stone to provide intensive residential error. The diagnosis was completely treatment services (IRTS) for adult changed in 21 percent of the cases residents with mental health condi- and 66 percent of patients received a tions. Staff will include a full-time on- refined or redefined diagnosis.
New Clinic and Pharmacy Opening Downtown Hennepin Healthcare System has opened its North Loop Clinic and Pharmacy, located on the first floor of the TractorWorks Building on Washington Avenue in downtown Minneapolis. It is the health care system’s eighth neighborhood clinic.
“This may prevent identification of diagnostic error, and could lead to treatment delays, complications leading to more costly treatments, or even patient harm or death,” said James Naessens, ScD, a health care policy researcher in the Division of Health Care Policy and Research and the Center for the Science of Health Care Delivery at Mayo Clinic. “We want to encourage second opinions when the provider is not certain.”
The 6,300-square-foot clinic offers primary care; dermatology care; allergy care; women’s health, including nurse midwives and OB/ The researchers also identified GYN specialists; integrative health costs associated with second opinservices such as acupuncture and chiions. “Total diagnostic costs for cases ropractic care; laboratory services; resulting in a different final diagnosis and an on-site pharmacy. were significantly higher than those “In addition to general derma- for confirmed or redefined diagnoses, tologic care, we are also offering but the alternative could be deadly,” cosmetic dermatology at the clinic,” Naessens said. The team plans to said Jane Hess, DO, clinic medical conduct further research on diagnosdirector. “Botox, micro needling, tic errors and hopes to identify ways cosmetic fillers, chemical peels, and to improve the process. “Referrals other procedures are available, and our adjoining pharmacy will carry a News to page 6 variety of cosmetic products.”
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MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
News from page 5
In addition, Children’s pediatric intensive care unit on its Minneapolis campus is currently running a streak of 500 days without a CLABSI. According to the Centers for Disease Control and Prevention, CLABSIs result in thousands of deaths each year and billions of dollars in added costs even though they are preventable.
to advanced specialty care for undifferentiated problems are an essential component of patient care,” said Naessens. “Without adequate resources to handle undifferentiated diagnoses, a potential unintended consequence is misdiagnosis, resultPatsy Stinchfield, senior director of ing in treatment delays and compliinfection prevention and control at Chilcations, and leading to more costly dren’s, credits the success of the St. Paul treatments.” pediatric intensive care unit to a combination of processes implemented at the hospital level and the unit level, which she Children’s Celebrates says both have an intense culture of safety.
Patient Safety Milestone
Children’s Hospitals and Clinics of Minnesota has gone two years without a central-line associated bloodstream infection (CLABSI) in its St. Paul hospital’s pediatric intensive care unit. The milestone follows other successes in preventing CLABSI—the health care system has been CLABSI-free for five of the past nine calendar years. In total, the unit has had 2,570 days without a CLABSI, making it a record for Children’s.
STDs and Injection-Drug Related Infections Rising
reaching a new high of 22,675 cases in 2016 and showing a 7 percent increase from 2015. Gonorrhea remained the second most commonly reported STD in the state, with 5,104 new cases, showing a 25 percent increase in new gonorrhea cases from 2015. There was a 30 percent increase in new syphilis cases, with 852 new cases in 2016 compared to 653 new cases in 2015. The number of HIV “This alarming rise in STDs and cases reported in Minnesota stayed hepatitis C is of urgent concern,” about the same, with 290 cases in said Ed Ehlinger, MD, Minnesota 2016 compared to 298 in 2015, and commissioner of health. “MDH and the number of acute hepatitis C cases local public health departments, clireached a new high of 51 cases in nicians, and our community partners 2016 compared to 37 in 2015. are using every resource we have to Health officials recommend maintain the health of Minnesotans and protect them from the health annual testing for anyone who is sexuconsequences that can be caused by ally active and those who inject drugs. untreated disease. If funding for the “These diseases usually do not prevention of infectious disease in show physical symptoms immeMinnesota continues to be reduced diately,” said Kristen Ehresmann, as we have seen in recent years, we director of the infectious disease epwill not be able to put an end to these idemiology, prevention, and control rising infection rates.” division at MDH. “Early diagnosis The number of HIV cases in Minnesota remained about the same, however more new HIV infections were found among communities of color and injection drug users than in other groups. In addition, there was a 38 percent increase in rates of new hepatitis C infections, over half of which were found in patients that reported injection drug use.
The annual surveillance report on sexually transmitted disease (STD), HIV, and hepatitis from the Minnesota Department of Health (MDH) has shown that STD rates continued to rise in 2016 compared to 2015. The report showed that chla- and treatment are critical for the Overall, there was a 10 percent increase in new chlamydia, gonorrhea, mydia is the most commonly re- well-being of the patient as well as ported infectious disease in the state, disease prevention.” and syphilis cases combined.
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
PEOPLE JENNIFER BRICKLEY, RN, immunization program coordinator for primary care practices at Mayo Clinic, has been named a Centers for Disease Control and Prevention (CDC) Childhood Immunization Champion for her work promoting childhood immunization in Minnesota. In her current role, Brickley implemented a set of protocols used in clinics throughout Mayo Clinic Health System that allow for more timely vaccination; ran a recall program to notify families when a child is due for vaccines, which resulted in a 50 percent reduction in the number of 24-month-old children who were not up to date; and led an initiative to expand online vaccine information support for clinicians and nurses to use when talking to patients. In addition, she serves as the chair-elect on the board of directors for the Southeast Minnesota Immunization Connection, the region’s coordinator of Minnesota’s immunization registry. She collaborated with private practices, public health organizations, and schools to lead a school immunization program for Olmsted County public and private schools and met with clinics to improve their immunization programs. LINDA BEARINGER, PHD, MS, RN, who most recently served as a professor in the University of Minnesota’s School of Nursing and director of the Center of Adolescent Nursing, has received the Outstanding Achievement in Adolescent Health and Medicine Award from the Society for Adolescent Health and Medicine for her commitment to improving health and health care for young people. Throughout her 32-year career, she served on adolescent health expert panels for several organizations, including the World Health Organization, UNICEF, and the National Institutes of Health; served as president of the International Association for Adolescent Health from 2009 through 2013; and received 10 federal training grants in adolescent health and adolescent nursing, which provided specialized training for students. She was a founder of the annual Minnesota Summer Institute in Adolescent Health, through which participants expand both adolescent health content expertise and teaching/learning strategies. Bearinger received a master’s degree in community health nursing from the University of Colorado and a PhD in educational psychology from the University of Minnesota.
BRUCE THAO, MA, MS, has been named director of the Center for Health Equity at the Minnesota Department of Health. Most recently, Thao managed the Linking Leaders initiative at the F.R. Bigelow Foundation, a cross-sector effort to advance racial equity in leadership. Prior to that, he served as director of programs for Hmong American Partnership (HAP), where he oversaw many public health programs. Thao also has experience as a community organizer, having managed HAP’s MNsure outreach and enrollment efforts—he was named a Champion of Change for Healthcare by the White House for his role in those efforts. His experience also includes policy work at the local and national levels, including his advisory role to the mayors of St. Paul and Minneapolis on a local initiative for boys and men of color as part of the “My Brother’s Keeper” initiative. Thao earned his master’s degree in psychology at Saint Joseph’s University and a master’s degree in social welfare from the University of Chicago.
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Prescription drug prices skyrocket Bipartisan legislative solutions
rescription drug costs are skyrocketing across Minnesota and the country, and families are paying the price. Take Clare from St. Paul. The price of Remicade, which Clare had relied on to treat her arthritis, jumped from $60 to $1,400 per vial overnight. This staggering price hike is just too much for a senior on a fixed income, so Clare has been forced to stop taking the medication she needs.
Senator Amy Klobuchar, JD Sen. Klobuchar has earned a reputation as an effective, results-driven legislator willing to reach across the aisle to get things done. In the Senate, she has supported efforts to reduce the cost of health care for families and businesses and to reward efficient, costeffective results. She has also been an outspoken advocate for the importance of science in advancing new medical breakthroughs. She has consistently pushed to maintain strong federal funding for the National Institutes of Health, supported the bipartisan Stem Cell Research Enhancement Act, and authored successful legislation to promote early detection in breast cancer patients.
Clare’s story is heartbreaking, and it’s all too common. The price of insulin tripled over ten years. The price of the infectious disease drug Daraprim increased 5,000 percent overnight. The antibiotic doxycycline went from $20 to over $1,800 a bottle in six months. And, of course, the price for an EpiPen shot up by nearly 500 percent since 2009. I’ve heard from many Minnesotans like Clare who may risk their health because they can’t afford to fill a prescription; who seek out opportunities to buy the medication from other countries; or who face the grim choice between paying for groceries or paying for medication.
Reaching across the aisle That’s why I’ve been working with Republicans and Democrats to tackle this issue. President Trump has also signaled support for lowering prescription drug costs. I believe we have a real opportunity to work together, pass legislation with concrete solutions, and make a real difference—and that’s exactly what I intend to do. One of my solutions is permitting Medicare to get a better deal for the more than 40 million seniors who participate in the Medicare Part D prescription drug program. Right now, the Veterans Health Administration can negotiate drug prices, but the law bans Medicare from doing the same. My Medicare Prescription Drug Price Negotiation Act would allow Medicare to bargain directly with drug companies for the best prices, which means more money in the pockets of taxpayers and seniors. In the long term, competition is the best way to ensure prescription drugs are affordable. When pharmaceutical companies are forced to compete, they have incentive to lower their prices. One way to do this is through imports— just look to our neighbors to the north. Canadians often pay much less for prescription drugs than Americans. In 2015, average prescription drug prices in Canada were less than half of U.S. prices. These are the same drugs, same safety standards, and same dosages sold here. My bill with Republican Senator John McCain would let Americans buy a 90-day supply of prescription drugs from an approved Canadian pharmacy.
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
And our Health and Human Services secretaries should have the ability to respond to major drug price increases in the same way they can respond to drug shortages: allow more competition from other countries. I’ve worked with Republican Senator Mike Lee on a proposal that does just that. If drug companies know an exorbitant price hike might trigger competition from abroad, they might think twice before raising prices.
Expanding access to generics Another way to promote competition is by encouraging Americans’ access to cost-saving generics. For example, we need to stop “pay-for-delay” deals: when a brandname drug company pays a generic drug competitor not to sell its products. These deals rob consumers of access to cheaper generic drugs. That’s why I teamed up with Republican Senator Chuck Grassley on legislation that would crack down on these anti-competitive payoffs. I’ve also worked with my colleagues from both parties on legislation that would end drug company tactics that slow down or prevent generic competitors from getting the approvals they need to sell their products. The longer the wait for competition, the more consumers have to pay.
In 2015, average prescription drug prices in Canada were less than half of U.S. prices.
Finding solutions The solutions are clear. Now’s the time to come together and pass this legislation for the sake of Americans across our country, including countless Minnesotans who’ve written to me about how their families are struggling to deal with rising prescription drug costs. Like Amy, who reached out to me after she went to the emergency room from a hornet’s sting and now worries about balancing the cost of her EpiPens and supporting her family. Or Kristine, who has to pay $4,000 out-of-pocket for her prescriptions. Or Kasey, who lays awake late at night, worrying about the cost of the drugs that keep her daughter alive. They don’t have time to waste.
rehabilitate a body, we start T owith the mind and soul. If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. Thatâ€™s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.
To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota.
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MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Reference laboratories WILLIAM MORICE, II, MD, PHD, is chair of the Department
continuously updated information on new tests and technologies. We produce care models that help guide usage of the right tests at the right time. And we avail our clinical experts to our client medical practices for real-time phone calls to address any questions about our testing, the results, and clinical interpretation and application of the information.
of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota, and president of Mayo Medical Laboratories (MML).
One of your roles at Mayo Clinic is president of Mayo Medical Laboratories, the global reference laboratory for Mayo. What is a “reference laboratory” and what does it do? A reference laboratory offers health care providers (e.g., hospitals, specialty clinics, health care systems, and small clinical laboratories) laboratory testing and interpretation services that are not readily available within their own practice. Patients may have their blood drawn at their local hospital or doctor’s office, but if their clinical management requires laboratory testing not available in their local hospital or via clinic tests, the samples will be sent to a reference laboratory. MML provides highly specialized testing that many hospitals and clinics cannot provide. Through educating practitioners about the availability and use of these tests and supporting their interpretation, MML is putting in the hands of local care providers the most advanced and appropriate tools to diagnose and manage a patient’s condition. Health care providers from all over the world can send their specimens to MML, and, if needed, they can speak with a Mayo Clinic physician about the results to help provide personalized, expert care for each patient.
How do these specimens get shipped to Mayo Medical Laboratories? We receive specimens from 70 different countries and from thousands of U.S. health care providers each day. FedEx delivers 65 percent of these specimens early each morning to our loading docks in Rochester, and another 10–15 percent arrive between midnight and 6 a.m. Most specimens arrive the day after the patient’s appointment time. On our busiest days, we receive 36,000 specimens. On our slowest day— Sunday—we could receive as few as 4,500 samples. Presorted specimens arrive in various states (80 percent refrigerant, 10–15 percent frozen, and 5–10 percent ambient), so it’s crucial to get them into the operation and to continue to stabilize them at the correct temperature before they are sorted, labeled, and sent to our 65-plus clinical laboratories.
How do you work with medical practices outside of Mayo Clinic? We see ourselves as an extension of the Mayo Model of Care to the local medical practice. Mayo Clinic and Mayo Medical Laboratories provide
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
What are some of the most common conditions for which you test? In my eyes, the measure of success of a reference laboratory lies in how uncommon our testing is. The common testing is, and should be, performed by the local hospital and its laboratories. We don’t want to be redundant or competitive. Only about 3 percent of testing performed in a community typically needs to be forwarded to a reference laboratory. To meet that need, our Department of Laboratory Medicine and Pathology offers more than 3,600 tests and collegial access to our more than 160 Mayo Clinic physicians and scientists within this department to help manage thousands of conditions.
Given the same sample, the level of accuracy and detail can vary between one lab report and another. What can you tell us about this? We make an acute distinction between a result and an answer. A result can be produced by a machine, but to evolve it to an answer, our laboratories are governed by the strictest quality measures, key performance indicators, validations, comparisons, and continuous evaluations by our laboratorians and practitioners in a patient-care setting. These measures are an investment to ensure that the answers we provide to help guide the management of each patient’s care are correct and clinically actionable.
How has genetic testing changed the work you do? The dawn of the “genetic medicine age” has been a great advancement for patient care. It allows us to identify and manage diseases more definitively, and it enables us to tailor care plans at a truly personal level. However, since many of these tests are expensive and difficult for patients (and even for care providers) to fully comprehend, it has also required a more diligent approach to laboratory test utilization management. Like any tool, we want to make sure these tests are used only when they are needed for the patient’s care. If we’re able to get a clinically actionable answer using a more cost-effective method, we want to do that instead of skipping right to the most expensive option. This is good medical practice; it is the best way to manage the cost of care and the impact to patients, hospitals, and insurers.
Please define pharmacogenomics and how it affects the practice of medicine. Pharmacogenomics is a type of personalized genetic medicine that seeks to understand how an individual will respond to a particular pharmaceutical (drug) therapy. The unique genetic makeup of people can tell us how they’ll metabolize a drug, how effective it will be in managing their conditions, and what the risk of particular side effects might be. This can help the treating physician to make therapy decisions
that are in the best interest of each patient, and can potentially steer a person away from an expensive therapy that might be ineffective. In addition to clinical and scientific capabilities, pharmacogenomics relies heavily on analytics and management of large sets of information. It has created a strong climate for collaboration between medical practices and technology companies.
The answers we provide...help guide the m anagement of each patient’s care.
The Minnesota Board of Medical Practice will soon license genetic counselors, who will then be able to order genetic testing. How will you work with these health care professionals? Mayo Clinic has had highly qualified, certified genetic counselors on staff for many years to guide our application of advanced genetics and to discuss these tests with patients. They “wrote the book” on genetic counseling (Practical Genetic Counseling for the Laboratory). Our genetic counselors work not only with Mayo practitioners, but also with practitioners and genetic counselors around the world—it’s a very collegial field. We see any efforts to drive the practice of good medicine forward as positive, and the developments here in Minnesota are no exception.
Advances in medical science now outpace our ability to effectively integrate them. How can we speed up the integration process? The demand for proven care models and utilization guidance is growing exponentially as advances in clinical testing proliferate. In essence, the tests are the ingredients, but the care models are the recipe. At Mayo Clinic, our focus is not only on adding new tests to the menu, but in creating accompanying evidence that shows practitioners when, where, and why to use these tests in the management of a particular condition to ensure that the testing is leading to the best outcome at the most efficient delivery cost. I believe sound utilization guidance is every bit as additive to the field of health care as the clinical tests themselves.
What are some of the most exciting advances that you foresee? We have an unparalleled opportunity to make insights into human disease that we’ve never been able to make before. As professionals of laboratory medicine, we can now take the “constellation” of that universe of information and provide specific, unique details around individual patients and even about their individual cells. We can now provide better, more thorough, more meaningful information to care providers, who can then speak with their patients about what’s next for them. In the end, it’s really exciting if I know that someone sitting with a patient can say, “I can make an insight today about your disease that I could not have made five years ago. I can tell you what it means for you.”
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Joint replacement surgery Helping maintain a healthy lifestyle By Dane Hansen, DO
e depend on healthy knees and hips to perform our jobs and enjoy our lives. When joint pain makes activity painful, our lifestyle—and livelihood—can suffer. Joint replacement procedures make a significant contribution to general health by helping people stay physically fit and active. These surgeries are successfully performed over 1 million times each year in the U.S., but some people are hesitant to consider surgery, or think of joint replacement as a solution reserved for elderly patients.
Understanding the causes of joint pain, treatment options, and how joint replacement surgery works can help you make informed medical decisions about how to treat a sore knee or hip. Conditions causing joint pain There are two general categories of joint pain: acute injuries and degenerative chronic conditions. Acute injuries are sudden injuries suffered in car crashes, sports accidents, or falls, causing everything from damaged knee cartilage (meniscus tears) and pulled muscles to more serious joint damage. Chronic conditions arise gradually over time. Degenerative and inflammatory arthritis are the main culprits. Degenerative arthritis is caused by joint wear and tear over time, and may be aggravated by repetitive use or by previous trauma. Surgeries can increase the risk of developing an arthritic joint, particularly surgeries to treat cartilage damage or meniscus tears. Excess weight may also take a toll on joint health, and place excess strain on knees. Finally, inflammatory and rheumatoid arthritis—both autoimmune conditions—may cause joint pain and degeneration over time. Non-surgical treatment options A sore knee or hip doesn’t always require a joint replacement. Joint pain can frequently be managed with conservative, non-surgical treatments. Oral anti-inflammatory medications for pain and swelling work well for strained muscles and tendonitis, as well as for mild arthritis. If oral medications don’t relieve joint pain, steroid injections can be very helpful. Other conservative treatments include physical therapy, ultrasound and electrical stimulation, heat and ice treatment, and massage. When joint pain is caused by arthritis, conservative treatments should be managed with special care. Anti-inflammatories and steroid and gel injections can be beneficial, but sometimes lose their effect over time. Similarly, advanced arthritis may be exacerbated by heavy exercise. However, options such as gentle therapist-guided exercises and bracing can be tailored to a patient’s individual condition to relieve pain and maintain activity levels.
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Surgical joint procedures When joint problems don’t resolve under conservative care, two types of surgeries are available: Minimally invasive arthroscopic treatments utilize tube-like endoscopes, inserted through small incisions in the skin. Using sophisticated cameras and special tools, the surgeon repairs and preserves the function of existing ligaments and cartilage. These surgeries can treat several conditions, including impingement issues in hips, ligament tears in knees, and some mild early arthritis damage. Although arthroscopic surgery is sometimes used to repair cartilage tears, serious cartilage damage and advanced arthritis in the joint is difficult to repair. This more serious joint damage usually requires an operation to replace the joint. Joint replacement surgery removes part or all of a damaged joint and replaces it with an artificial joint. Partial joint replacements are possible in the knee joints, but hips are almost always treated with a total joint replacement. There’s a perception that total joint surgery cuts out the entire joint and replaces it with a large mechanical knee or hip—the reality is far less dramatic. Think of a total joint procedure as a resurfacing-type procedure. These surgeries remove only the damaged cartilage and bone from the joint and replace it with smooth metal and plastic pieces that function as a new joint surface—with minimal damage to the surrounding ligaments, muscles, and soft tissues.
several weeks, long-term function can be compromised, making it difficult to perform activities such as squatting and kneeling. The hard work pays off, however, and after a few weeks, most patients feel comfortable and confident and the rehabilitation shifts focus to strengthening the muscles and getting back to normal activity. I believe that most patients with knee replacements are around 85 to 90 percent improved by three months and are enjoying an active, pain-free lifestyle again.
Think of a total joint procedure as a resurfacing-type procedure.
Hips typically heal faster after replacement surgery, and usually with less pain. There may be movement restrictions for the first few weeks after surgery, but rehabilitation is focused on improving your walking and getting the strength back into the hip muscles. By 6–8 weeks, most hip replacement patients are returning to normal activities while continuing to build strength.
Joint replacement surgery to page 34
Most knee replacement surgeries use bone cement to attach the metal pieces to underlying bone. Hip replacements are handled differently because the anatomy allows for a tighter, circumferential fit of the metal implants. Artificial hip replacement joints are designed with a special metal that has the same porosity as bone. Your bones actually grow into the metal pores of the replacement joint and it becomes fixed to your skeleton. Because the size of joints varies with each patient, hip and knee replacements come in multiple sizes, with a selection of plastic spacers to ensure that the new joint has a tight fit. Initial sizing decisions are made prior to surgery using X-rays. Final adjustments are made during the surgery to maintain correct leg length and the right amount of tension on the muscles and ligaments around the joint. Maximizing outcomes through rehabilitation There’s always going to be a period of discomfort following knee or hip replacement surgery, but overall recovery is very successful in both. With both knee and hip replacements, people are able to put their full weight on the new joint immediately—you are usually up and walking within hours after surgery. Patients who’ve had both hip and knee replacements usually say that knee replacement surgery is more difficult and painful to recover from. Knees swell more than hips, so early rehabilitation is focused on reclaiming your range of motion, which can be challenging. If motion isn’t fully recuperated within the first MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
BEHAVIOR AL HEALTH
Psychiatric medications Understanding how they work By Marie Casey Olseth, MD
any patients get referred to me after having tried multiple psychiatric medications, none of which provided effective relief of their symptoms. They are understandably frustrated and skeptical about seeing a new psychiatrist, let alone trying any new psychiatric medications. This frustration may increase if they consult “Dr. Google” or ask non-medical professionals for information. Multiple factors must be considered before making any decision about prescribing
psychiatric medications. That’s why I make it a priority to educate my patients on how I come to a decision about the medication—and the dosage—that I recommend. As a result, they feel more informed and more comfortable with the decision to start the medication. Common questions The discussions are as varied and unique as the patients themselves, but some common themes do recur. Here are some examples. “I already tried that medication and it didn’t work.” In many cases, the patient was actually taking a psychiatric medication that would have been effective for the symptoms, but had been prescribed at the incorrect dosage. For example, one patient was recently referred to me after finding gabapentin ineffective in treating his anxiety. Further discussion revealed that he had been prescribed a dose that was sub-clinical—in other words, it should have worked, but he was not taking enough of it to be effective. He was skeptical of the recommendation to try gabapentin once again at an appropriate dose, but was later amazed at the relief it provided, essentially eliminating the formerly paralyzing impact of anxiety on his life. The correct dosage can make the difference in the effectiveness of some medications. “2mg of Xanax every day works fine. Why should I change it?” Other referrals come from primary care physicians urging their patients to find safer alternatives to the higher-risk psychiatric medications they currently use. Many of these patients don’t want to eliminate the higher-risk medication—a controlled substance, for example—because they have developed an emotional attachment to and/or a dependency on the medication. In many cases, the patient was initially prescribed the controlled substance with instructions to use it only “as needed” (sometimes written on the prescription pad or pill bottle label as PRN, for the Latin term pro re nata). The prescriber may have intended this to mean less than once each day, but, over time, some patients increase their intake to get more symptom relief, ultimately taking the medication multiple times daily.
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Patients may not appreciate the many risks of certain medications, and may not understand that their psychiatric symptoms could be managed with other, safer alternatives. I advise patients that, as psychiatrists, we have many tools in our medication toolbox to manage their symptoms. We draw upon our knowledge and experience to make recommendations regarding medications. Patients are often initially skeptical and nervous, but after they become comfortable with the recommendations and then transition to safer medications to manage their psychiatric symptoms, they are surprised at how effective the safer psychiatric medications are at managing their symptoms.
except that, in this case, the therapists work to optimize your mental health. The therapist coaches you on changing cognitive and behavioral patterns, moving from patterns that cause and reinforce psychiatric illness to patterns that promote optimal mental health. I sometimes follow a 70/30 rule in prescribing, dosing the psychiatric medications to achieve 70 percent relief of the symptoms. This decreases the symptoms enough for a person to be comfortable enough and to have enough emotional strength to work on their symptoms in therapy. Eliminating all psychiatric symptoms with medications may remove incentives to regularly rehearse the skills and behaviors taught in therapy. For some patients, this 70/30 rule provides
There are many examples of this, but using the Xanax case as an example, some patients who use Xanax multiple times each day
Psychiatric medications to page 32
are often surprised that their anxiety might be better controlled by some other medication. It was not until getting off of Xanax that they realized how multiple daily doses contributed to daily discomfort and to intraday withdrawal symptoms as the effect of the medication wore off. Patients also tell me that their thinking was “foggy” while on Xanax, but that the medication we transitioned them to managed their anxiety without negative cognitive impacts. As with any prescription medication, side effects may vary considerably from patient to patient. The treatment regimen that works perfectly for one individual may be ineffective for another, so it’s important to raise concerns with your provider. “You are recommending two medications. I used to be on just one.” A top priority in managing psychiatric conditions is to minimize “medication burden”—the negative impact that a drug causes on a person’s physical and cognitive health. Complications related to medication burden could be temporary, lasting only while the person takes the drug, or could result in cumulative, long-term effects.
The goal is to help patients manage their psychiatric condition with minimal medications. Reducing medication burden often involves reducing the number of medications. Other times, it involves replacing one highrisk medication with two safer medications that, taken together, can manage the same symptoms. Psychiatric medications as “training wheels” Many patients want help, but do not want to take psychiatric medications. The goal is to help patients manage their psychiatric condition with minimal medications. Some psychiatric conditions are chronic and severe, and do indeed require long-term use of medications. But many patients manage their psychiatric illness with a time-limited course of medications, using the drugs as “training wheels” to treat a condition while simultaneously attending regular therapy appointments to develop new skills. Ongoing therapy is similar to utilizing a personal trainer to motivate and train you, MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Dry eye disease Symptoms, causes, and treatments By Michael V. Dieter, OD
ry eye disease—a condition that ranges from mild annoyance to life-altering disability—strikes 10 percent of the U.S. population, and is even more prevalent in some other countries. This growing worldwide problem can be aggravated by environmental conditions and computer usage, but each case is unique, and requires individualized treatment tailored to the needs of the patient. Dry eye affects all populations, but is more common among women and older patients.
Symptoms The International Dry Eye Workshop (DEWS) defines dry eye as a multifactorial disease of the tears and the eye’s ocular (front) surface that results in symptoms of discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. It can be accompanied by inflammation and high levels of saIt in the tears (hyperosmolarity). No single description captures all of the variations and subtypes of this disease, however, and clinicians continue to debate even at this most basic level of theory. Patients know the symptoms all too well: eyes that feel dry, burn, sting, and ache, with discomfort lasting much of the day. Moving air, defrost from the car, and air conditioning will provoke symptoms, as will sustained computer work. Closing the eyes can help, so many patients simply go to bed early. Artificial tears often provide temporary relief, but symptoms can quickly return. Vision may fluctuate, especially toward the end of the day. Red eyes do not usually signal dry eye, but they may accompany the condition. Allergy, a separate disease of its own, may also contribute to dry eye difficulties. Multiple causes Researchers use the term “multifactorial” to underscore the many causes and exacerbations of dry eye. For example, low humidity will cause tears to evaporate more quickly. Side effects from medications can result in lower tear production, and hormonal changes can diminish oil secretion. Nerve fibers may be damaged by eye surgery or by herpes simplex or herpes zoster viruses. In addition, vitamin A deficiencies may hamper proper development of tissues; trauma to stem cells may stifle healing; reactions to medications may cause loss of mucous membranes; and corneal nerves can become diseased, resulting in hyper- or hypo-sensitivity. In short, a problem that begins in any part of the lacrimal system (which produces and drains tears) can lead to dry eye.
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Healthy tears Your cornea generates the frequent symptoms of dry eye. Covering the pupil and the colored part of the eye, this clear, living tissue provides a window for light to pass through. Two factors distinguish the cornea from all other tissues. First, it houses the body’s highest concentration of nerves; even our fingertips, designed for feeling, do not compare in sensitivity. As a result, the cornea efficiently senses and sends pain signals to the brain. Second, the cornea contains no blood vessels, drawing nutritional support instead from a threelayer film of tears. These two factors—pain sensitivity and tear film—are central to understanding dry eye. Your tears do far more than moisturize. In truth, the tear film supports complex chemistry at many cellular sites, and is crucial to the very health of the ocular surface. The tear film moisturizes, delivers nutrition and oxygen, removes waste, prevents against toxic invasion, and fights off harmful microorganisms, all while maintaining a smooth, transparent cornea. These tasks are controlled by a series of correct chemical reactions at the cellular level, the sending and receiving of proper signals by the nervous system, and a balanced input of hormones stimulating specific tissue receptors. Some of these intricacies are understood, but despite a growing body of worldwide research, there are still many unsolved mysteries. Three layers of fluid comprise the tear film:
meibomian glands in the upper and lower eyelids, with openings on the lid margin. With each blink, the eyelids come together with enough pressure to push a small amount of oil from these glands. When the eyelids open, the oil coats and floats on top of the tear film. Unlike water, oil does not evaporate—think of a spot of motor oil on your garage floor or on top of a lake. This thin, outermost oil film forms an anti-evaporative, protective coating on the vital tear film it covers. Dry eye: a breakdown in the system When the lacrimal system functions properly, sensors on the ocular surface send a message to the brain calling for tear refreshment. The brain responds with a message to the muscles in the eyelid. The resulting blink is like a windshield wiper, spreading a layer of new tears, composed of mucin, aqueous fluids, and a thin top film of oil, evenly over the front of the eye. To maintain good working order, this blinking repeats, on average, 20 times per minute during waking hours. The intricacies of the lacrimal system are much more involved, but this is a basic explanation of normal functioning. “Dry eye” is the most common term describing the malfunction of this system. Other terms, such as dysfunctional tear syndrome,
Dry eye disease to page 19
The mucin layer, which adheres to the outer layer of the cornea (the corneal epithelium), forms a foundational moisturizing layer over the mucous membrane that covers the ocular surface—much like the mucous membrane that keeps your inner cheeks moist. Without this protection, the surface corneal cells would actually repel water, but this response is countered by mucin-producing cells
Blinking repeats, on average, 20 times per minute during waking hours. on the ocular surface that provide coating and attract available moisture, keeping the surface moist, soft, and smooth—as long as there is moisture available. The aqueous layer, secreted by lacrimal glands tucked beneath the upper eyelid, represents the largest volume of tears. Small, specialized lacrimal glands on the inner surface of the eyelid contribute additional tear fluid. Together, these continual secretions form an aqueous mix that delivers the ingredients necessary to keep the front surface of the eye healthy: nutritional components, electrolytes, growth factors, germ-fighting capabilities, oxygen, and water. The oil film, comprising just 1 percent of your tears, forms the outermost layer. Most of this thin oil film comes from a row of
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
CALENDAR Arthritis Awareness Month The Arthritis Foundation works during National Arthritis Awareness Month to spread information about arthritis, which is the leading cause of disability in the country. It affects nearly 53 million people in the U.S. and that number is expected to grow to 67 million by 2030. There are more than 100 types of arthritis and related conditions. It affects people of all ages, sexes, and races, but is most common among women and occurs more frequently as people age. Common symptoms include swelling, pain, stiffness, and decreased range of motion. They can range from mild to moderate or severe, and may come and go. At its worst, severe arthritis may lead to chronic pain, trouble with daily activities, and difficulty with mobility. It can also cause permanent changes in the joints, which usually are not visible. If you are experiencing any of these symptoms, talk to your primary care provider. Diagnosis begins with a physical exam and may include blood tests and imaging scans to help determine the type of arthritis if it is present. For those who are diagnosed, there are many options for ways to preserve joint function, mobility, and quality of life. Education, remaining physically active, and maintaining a healthy weight are important in managing any type of arthritis.
Arthritis Support Group
Arthritis Introspective and the Arthritis Foundation offer this free support group for adults living with all types of arthritis and rheumatic diseases. Come connect, learn, and empower yourself. Spouses, significant others, and loved ones are welcome. RSVP required. For more information, visit arthritisintrospective.org/ aiss/mn-maple-grove. Monday, June 12, 6:30–8:30 p.m., Ridgedale Public Library, 12601 Ridgedale Dr., Minnetonka
Memory Loss Discussion Group
The Amherst H. Wilder Foundation offers this free monthly memory loss discussion group for caregivers of people with memory loss. Come connect with other caregivers to gain support and share advice. On-site respite is available with pre-approval. For more information, call Barb at (651) 280-2546.
Prostate Cancer Support Group
Fairview offers this free support group for people affected by prostate cancer and their loved ones. Come connect with other survivors and caregivers to support and educate each other. Light refreshments will be available. For more information, call (612) 672-7272. Thursday, June 8, 6–8 p.m., Hope Lodge–Richard M. Schulze Family ACS, 2500 University Ave. SE, Minneapolis
Car Seat Clinic
Regions Hospital offers this free child and booster seat safety clinic. Certified car seat technicians will teach you how to install and use child care restraints correctly. Other dates and locations are available. Call (651) 357-2798 for more information or to make an appointment. Saturday, June 10, 9 a.m.–12 p.m., Regions Hospital, South Ramp, 640 Jackson St., St. Paul
Yoga for Parkinson’s
Allina Health hosts this free support group for parents who have experienced a loss and are planning for or expecting a child. Come receive guidance on grieving, healing the past, and connect with other parents who have experienced a loss to help realize your feelings are normal. Preregistration requested. Call Annette at (651) 241-6206.
Varicose Vein Screenings
Park Nicollet offers free screenings for anyone bothered by visible, bulging veins in their legs that cause pain, swelling, or cramping. Surgeons will perform the screening and recommend a course of action. Those covered by Medicare or Medicaid are not eligible due to federal regulations. Other dates are also available. Call (952) 993-2651 to schedule your screening. Tuesday, June 20, 3:30–4:30 p.m., Methodist Hospital, Women’s Center, 5th Floor, 6500 Excelsior Blvd., St. Louis Park
Deaf and Hard of Hearing MS Group
The National Multiple Sclerosis Society offers this free monthly support group for anyone who is deaf or hard of hearing and affected by multiple sclerosis. ASL interpreters are provided at each meeting. Call Marcia at (651) 582-7422 (Video Relay Service). Saturday, July 1, 1–2:30 p.m., Fairview Ridges Education Center, 152 Cobblestone Ln., Burnsville
HealthEast offers this yoga class that is designed specifically for people living with Parkinson’s disease to help improve balance, coordination, concentration, strength, and mental well-being. This is a weekly class and there is a $5 per session cost, but no charge for caregivers/care partners. Call Jill at (651) 232-2776 to register. Wednesday, June 14, 11:30 a.m.–12:30 p.m., Bethesda Hospital, 7th Flr. Conference Center, 559 N. Capitol Blvd., St. Paul
Pregnancy After a Loss
Monday, June 19, 5–6:30 p.m., United Hospital, 333 Smith Ave. N., St. Paul
Thursday, June 8, 10–11:30 a.m., Wilder’s Community Center for Aging, 650 Marshall Ave., St. Paul
Mobile Health Screenings
UCare, Hennepin County Medical Center, and KARE 11 TV host this opportunity for free basic health screenings. Nurses will perform the health checks in a mobile RV unit. Other dates and locations are available across the metro area. The events are open to the public and screenings are performed on a first-come, first-served basis. For more information, call (763) 797-7299. Sunday, July 9, 12:30–4 p.m., Green Central Park Elementary School, 3416 4th Ave. S., Minneapolis
America’s leading source of health information online 18
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Dry eye disease from page 17
meibomian gland dysfunction, and keratitis sicca, may more accurately convey the specific problem, but the public and the professional field understand what is meant by the term “dry eye,” which has led to its acceptance. Multiple treatments Given this range of causes and complications, your eye doctor may employ both conventional methods and new technology to diagnose dry eye. A thorough case history is essential, with pertinent questions from a clinician familiar with this field. Examination will further determine: if adequate tearing is present, if signs of dryness exist on the front surfaces, if oil is properly secreted from the glands, if inflammation is present, and the health and condition of the eyelids. Your doctor will also assess responses to in-office therapy and follow-up visits to further guide and confirm the diagnosis. In short, if it sounds like, looks like, responds like, and improves like dry eye, it usually is dry eye. Therapies now abound for this condition, varying from useless to essential. For specific subtypes of dry eye disease, gains are being made by procedures, medicines, and lifestyle instructions. For example, dry eye caused by androgen deficiency differs in therapy from ocular rosacea dry eye, a condition marked by inflammation, redness, and
burning or foreign body sensation. Autoimmune problems require therapy different than evaporative dry eye types. General goals are to eliminate chronic inflammation, control hyperosmolarity, reduce tear evaporation rates, restore the ocular surface, and ensure eyelid margins are very clean. Research and clinical attention to dry eye continue to yield better outcomes in therapy.
Therapies now abound for this condition, varying from useless to essential. At a glance Years ago, patients with dry eye problems were told that it was a natural part of aging, and eye doctors offered little help or relief. Today, with greater understanding of this disease and the tools to remediate it, improved treatments yield better outcomes to a condition that interferes with daily functions and comfort. This multifactorial disease requires specific therapies dependent on the cause.
Michael V. Dieter, OD, is an optometrist and founder of Dry Eye Clinic, LLC, in Maple Grove, Minn.
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
COMMUNITY CAREGIVERS Recognizing Minnesota’s Volunteer Physicians By Lisa McGowan
Edward Martin-Chaffee, MD Each year, Minnesota Physician Publishing recognizes physicians and health care providers who have volunteered their medical services. Whether volunteering at home or overseas, these caregivers help people in need and come away with a revitalized sense of their work. Their compassion, commitment, and generous spirit reflect the deeply held values in Minnesota’s medical community.
CentraCare Health System
or 15 years, Camp Odayin in Minnesota and Wisconsin has offered kids with congenital or acquired heart disease a wonderful, monitored camp experience. Dr. “Chip” Martin-Chaffee has volunteered at Camp Odayin as a camp physician for 10 years and as camp medical director for seven of those years before recently stepping down from the director’s role. These kids often feel like outcasts because of their conditions and surgical scars, but at camp he has watched kids blossom, let their guard down, and connect with kids who face similar challenges. According to Martin-Chaffee, “Volunteering allows me to see children with congenital heart disease outside of a medical setting. I’m a better pediatric cardiologist because I volunteer at camp.” Sara Meslow is executive director and founder of Camp Odayin. After receiving an implantable cardioverter defibrillator, she was inspired to open a camp in Minnesota for kids with heart disease. Kids from grades 1–11 are welcome at camp and participate in typical camp activities such as swimming, canoeing, and horseback riding. For each session, the camp is staffed with two
I’m a better pediatric cardiologist because I volunteer at camp. pediatric cardiologists and a cardiac nurse for every seven to eight children. The medical volunteers make sure the kids get and take their medicine, review charts, and offer medical care in case of a serious cardiac event. The vast majority of injuries, however, are camp related such as scrapes, bug bites, or swimmer’s itch. Martin-Chaffee, a neonatologist and pediatric cardiologist at CentraCare Health, recalls how Meslow called him out of the blue to see if he would be interested in volunteering at camp and he has been going for a week every summer since then. Kids are often nervous before attending Camp Odayin for the first time and their parents are often afraid to let them go. Martin-Chaffee remembers a young teenage patient of his who he encouraged to attend camp. “This young man lived in a small town and didn’t know anyone else who had undergone heart surgery,” said Martin-Chaffee. “I got a letter from his mother after he got home from camp thanking me for encouraging him to attend.” The teen had not been able to stop talking about his time at camp and he continued to go every year after that. At camp, kids learn that their heart disease does not define who they are. Camp Odayin’s motto is: Kids play, worries rest, and fun happens. “That’s why camp is so important,” said Martin-Chaffee. “Kids can just concentrate on being kids.”
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Patricia Walker, MD, DTM&H
Galen W. Stahle, MD
HealthPartners and University of Minnesota
Anxiety and Depression Clinic of the Twin Cities
ealizing that the strongest impact she can make as a volunteer is by influencing public policy and opinion, Dr. Pat Walker has been a passionate advocate for refugee and immigrant families throughout her career. She specializes in internal medicine, tropical and travel medicine, and refugee and immigrant health and is the department chair of the Tropical and Travel Medicine Center and a staff physician at the Center for International Health at HealthPartners. In her regular job, she works with a diverse group of Somali, Hmong, Bhutanese, Nepali, Cambodian, and Vietnamese colleagues. “These nurses, doctors, pharmacists, and social workers came here for a better life and have made me a smarter, kinder, and better person and America a better country,” noted Walker. Walker currently serves as volunteer president of the American Society of Tropical Medicine and Hygiene (ASTMH), and is only the sixth woman to serve in this capacity in the past 113 years. Through her work at ASTMH, Walker has advocated for more permanent funding for tropical medicine research, and for evidence-based public policy as it relates to refugees and migrants. She often travels to Washington, D.C. to meet with leaders and helped craft the Society’s statement urging President Trump to rescind his executive order on immigration. To mentor the next generation of leaders in global health, ASTMH has given almost $2.5 million in scholarships to students and trainees and encourages them to run for leadership positions. According to Walker, “We must engage with and learn from international colleagues in our quest to reduce health disparities worldwide.” Walker was brought up in Bangkok, Thailand and has always felt strong ties to Southeast Asia. During her third year of medical school, she
We must engage with and learn from international colleagues in our quest to reduce health disparities. volunteered on an international medical team with the American Refugee Committee to help Cambodians fleeing to Thailand after the genocide in 1979. As the volunteer medical director for the International Rescue Committee in Thailand from 1975–1979, she traveled by fishing boat to provide medical care to refugees suffering from malaria, malnutrition, and dehydration. Walker remembered, “Those were some of the saddest and most rewarding days of my career.” Walker’s advice to other providers is to listen more, try to understand other perspectives, and to commit to a lifelong journey of education, understanding, and service. She remarked, “I am a student of the Dalai Lama and really believe as he teaches, that the ultimate goal of every human being is happiness. If we act based on our core values, we will be more compassionate and fulfilled.”
r. Galen Stahle, a psychiatrist who practices at the Anxiety and Depression Clinic of the Twin Cities, volunteers in Minneapolis for Comunidades Latinas Unidas en Servicio (CLUES) and at the COSMA (Centro Especializado de Salud Mental de Ayacucho) Clinic in Ayacucho, Peru. He has always been interested in cross-cultural psychiatry, which deals with how different cultures and countries face mental disorders. CLUES is a social service agency focused on providing mental health services to the Twin Cities Latino community. Stahle has volunteered at CLUES every Wednesday for the past 15 years. He does psychiatric evaluations of patients and prescribes and manages their medications. Stahle began volunteering at COSMA in Peru in 2008 with a small group of psychiatrists who travel to Ayacucho twice a year. Sister Anne Carbon, a Columban nun, founded the clinic in 2003 in order to offer support to those affected by the violence that ensued as the Shining Path tried to overthrow the Peruvian government in the 1980s and 1990s. “There had been much violence,
Giving needy people hope and help is incredibly rewarding. hatred, torture, and family dissolution and displacement and PAMS (Peruvian American Medical Society) felt that psychiatric care was needed,” said Stahle. He saw many children and adults suffering from depression, panic attacks, chemical dependence, and PTSD as a result of these guerilla attacks. He and his colleagues did psychiatric evaluations, managed patients’ medication, conducted grand rounds for case presentations, and gave educational lectures. They also provided care in people’s homes, nursing homes, and jails. Occasionally, Stahle and his colleagues have gone on outreach trips to smaller towns an hour or two away from Ayacucho. They often saw psychotic patients wandering the streets with no mental health care available. Caring families kept these patients at home as best they could. If the patients were aggressive, they might be locked in outbuildings by their families and fed through bars or windows. Stahle noted, “This was not a temporary arrangement. It sometimes seemed like a peek back into the Dark Ages.” Initially, COSMA consisted of one nurse, under the supervision of a psychiatrist in Lima, who went out into the streets of Ayacucho to track down patients and give them antipsychotic medications. In the early years, Stahle and his colleagues contributed a considerable portion of COSMA’s clinic budget so it could continue to function. Now the clinic functions independently with volunteer psychiatrists from Lima and financial support from the Brothers of Charity. “Giving needy people hope and help is incredibly rewarding,” said Stahle.
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
2017 COMMUNITY CAREGIVERS
Anthony Stans, MD Mayo Clinic
rateful for the many blessings that he and his family have, Dr. Tony Stans and his wife Lena talked about volunteering overseas 12 years ago. “My wife and I believe that we have a responsibility to provide service to those less fortunate. We wanted to instill this value in our children by example and experience.” To this end, the entire Stans family, including their three children who were ages 6, 7, and 9 on their first trip, has volunteered with Hands for Humanity in Portoviejo, Ecuador for the past 10 years. A pediatric orthopedic surgeon and surgeon-in-chief of the Children’s Center at the Mayo Clinic in Rochester, Stans operates on approximately 20 children on the yearly weeklong trips to Ecuador, while his wife and children volunteer at a local orphanage.
My family’s greatest motivation to volunteer has been our desire to help other people. Founded in 2002 by Kate Welp, a cardiac surgery nurse at Mayo Clinic, Hands for Humanity works to meet the needs of underserved children and families in Ecuador. They partner with the San Lucas Foundation, who runs a clinic in Portoviejo staffed by physicians specializing in pediatric care. The patients that Stans sees lack access to basic medical care because there is very little government reimbursement for care received. There is also a severe shortage of medical providers in general, and orthopedic surgeons in particular in Portoviejo. The volunteer team has made it a point to teach a local pediatrician the non-operative Ponseti casting technique used to treat infants with congenital clubfoot deformity and this has resulted in a dramatic reduction in the need for these surgeries. Stans said that they have tried to train local orthopedic surgeons to provide pediatric care, but they quickly leave Portoviejo as soon as they find a more lucrative position elsewhere. During the year between volunteer trips, local physicians identify the kids who may benefit from orthopedic surgery. When the medical team from the U.S. arrives, they spend the first day and a half examining around 70 children in order to identify the 20 who will be operated on. According to Stans, “We are very careful to offer surgery only to patients who have relatively straightforward problems with a high likelihood of success and a low complication rate.” Stans wants to encourage other providers to consider volunteering if given the opportunity. “My family’s greatest motivation to volunteer has been our desire to help other people. We have benefited at least as much as those we have tried to help.”
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Shana Sniffen, MD
Jamie Lohr, MD
University of Minnesota’s Masonic Children’s Hospital
he Karen (Kah-ren) people are an ethnic group from Burma/ Myanmar. The Karen have been one of the largest refugee groups coming to Minnesota over the last several years. They fled to refugee camps because of widespread human rights abuses in Burma. The Roselawn Clinic in St. Paul, where Dr. Shana Sniffen practices, conducts public health refugee screening exams for Karen refugees. Almost half of Karen families living in Minnesota receive their health care at the Roselawn Clinic. Sniffen splits her time with 75 percent clinical practice and 25 percent community work with the Karen community. Her community work is grant funded to develop the Karen Chemical Dependency Collaboration (KCDC) and she is dedicated to addressing social and medical disparities, and finding innovative health and well-being solutions for people from unique backgrounds. As part of her Bush Fellowship, she traveled to Burma and Thailand, including a refugee camp, to learn more about the Karen culture and experience. “My community and clinic work cross inform each other making me a better healer, doctor, and community advocate,” noted Sniffen.
arly detection of treatable newborn health conditions is the mission of the Newborn Foundation based in St. Paul, Minn. Annamarie Saarinen co-founded the Foundation in 2010 after her newborn daughter Eve’s life was saved because she was diagnosed with congenital heart defects at only two days old. Dr. Jamie Lohr met Saarinen when she cared for Eve as a newborn. They re-connected at a later point when Saarinen became interested in CCHD (critical congenital heart disease) screening, which had been dismissed by many pediatric cardiologists because of potentially creating the need for too many follow-up tests due to false positive screens. A team, including Lohr, was assembled to see if CCHD screening could be effective. According to Lohr, “Volunteering exemplifies the power people have when working together on something that matters to them.”
Volunteering exemplifies the power people have when working together.
A history of war trauma, displacement, decades of living in refugee camps, resettlement, transition, and adjustment to life in the U.S. have led to mental health issues and chemical dependency for many Karen refugees. Several years ago a Karen teen came to Sniffen for help with his addiction to meth. She found that organizations refused him treatment because he was under 18 and/or needed an interpreter. She felt terrible that she couldn’t get help for him. According to Sniffen, “This was the impetus (along with requests from Karen leaders) for starting KCDC and finding ways to break down barriers and open up access.”
Lohr has always been interested in volunteering from the time she organized 4H community service activities when she was in middle school. Most of Lohr’s volunteer work has centered around children. While in college, she volunteered at a middle school in Oakland, Calif. She worked with kids who had behavioral issues and taught them life skills. One young boy in particular, who was sullen and often a bully, opened up after she taught him how to work a combination lock. That broke the ice and he smiled, hugged her, and talked about his family life and struggles at school. Lohr noted, “This young boy taught me the importance of listening and connecting with others as part of our personal and professional lives.”
My community and clinic work cross inform each other making me a better healer, doctor, and community advocate.
Lohr, a pediatric cardiologist, who practices at the University of Minnesota Masonic Children’s Hospital, has been a consistent volunteer and medical envoy for the Newborn Foundation’s Minnesota-based global projects in neonatal screening, access to pediatric cardiac services, and medtech development for newborn and pediatric patients. She spearheaded the nation’s first multi-hospital pilot study done in collaboration with the Minnesota Department of Health, to study the use of pulse oximetry to diagnose newborns with hidden congenital heart defects. This work led to legislation requiring screening of all newborns for CCHD by pulse oximetry in Minnesota, setting the standard for other states and saving thousands of lives. Currently, Lohr is working with the Newborn Foundation on developing a screening tool to provide echocardiography support in places where no skilled echocardiographers are available. Lohr (second from the left) also helps raise funds for the Adult Congenital Heart Association and the Children’s Heart Foundation through the Congenital Heart Walk held in the Twin Cities every fall.
Sniffen is co-director of KCDC with two Karen leaders. They are working to address the harmful effects of drug and alcohol abuse in the Karen community. Hosting the programs of KCDC in the HealthEast Roselawn Clinic helps to destigmatize the issues. KCDC is working to set up a program that takes into account the Karen culture, trauma experienced before migration to the U.S., and the refugee experience into outpatient treatment and community support for addiction. They created a glossary of Karen language terms on mental health and addiction and have trained 77 interpreters. The KCDC collaborates with faith leaders, probation officers, and community organizations. “My Karen partners and patients are an inspiration in their incredible resilience, generosity, humor and commitment in helping people.”
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
2017 COMMUNITY CAREGIVERS
Loie Lenarz, MD Fairview Health Services
roviding free primary health care to the needy and uninsured is the mission of St. Mary’s Health Clinics (SMHC) based in St. Paul. Dr. Loie Lenarz, who recently retired as medical director of Clinician Professional Development at Fairview Health Services, volunteers at SMHC for a half day every other week. She initially joined SMHC as a member of their board of directors in 2004 and accepted the position of volunteer medical director in 2009 after her former medical school advisor Dr. Eugene Ott retired. “I considered it quite an honor to be asked to follow Dr. Ott,” said Lenarz. The Sisters of St. Joseph of Carondelet (CSJ) founded SMHC because they believe that health care is a basic human right. They work with hundreds of volunteers to provide health care and help low-income people find affordable health care coverage. They also conduct health promotions, health screenings, and health education and work in collaboration with other
It feels good to know that I am making a difference.
community organizations. Their clinics take place in spaces donated by churches, schools, and community centers in the Twin Cities. Lenarz’s family instilled in her the importance of helping others and creating a just society. She attended Catholic school where many of her teachers were CSJ nuns. In addition to her parent’s values, the nuns had a strong influence on her by stressing that individuals can make the world a better place. “Because of my connection to this community of strong, smart,
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
dedicated nuns who share my values, along with my calling as a physician, it made perfect sense to volunteer with SMHC,” Lenarz remembered. Lenarz’s work as volunteer medical director at SMHC involves the challenge of designing standard processes with the nursing supervisors to support their clinical work and provide the same quality of care that patients receive elsewhere. Because the clinic’s resources are limited and they are only open for one session per week in any given location, Lenarz helps determine which patients need to be referred elsewhere. She occasionally works a shift in the clinic if they are short staffed. Volunteering is very important to Lenarz because she gets to see how her work benefits those who have no access to health care. She believes that volunteers at SMHC really have an effect. “There are so many in need and volunteers can so easily meet that need. It feels good to know that I am making a difference.”
Rajesh Bhargava, MD Cuyuna Regional Medical Center
r. Rajesh Bhargava began his medical career as a medical officer in the Indian Army Medical Corps in the eastern Himalayas. During his free time he attended to local tribal people who had no access to health care. “I used to pack some basic supplies in my backpack and hike up to small mountain villages and set up impromptu clinics. In my culture, the highest form of service is delivered directly through your hands.” There was always a strong tradition of service in Bhargava’s family, and volunteering over the past 37 years has helped him stay grounded. He has worked in medical education, disaster relief, and direct patient care in over 20 countries over the years and has also served as a board member for Hillside International, Belize. In the past few years he has mostly volunteered through Project HOPE, a non-profit organization that “provides lasting solutions to health problems with the mission of helping people help themselves.”
In my culture, the highest form of service is delivered directly through your hands. A month after Hurricane Matthew hit southern Haiti last October, Project HOPE began airlifting medicine, supplies, and medical volunteers to the ravaged areas. Bhargava spent two weeks in Miragoane in southeastern Haiti providing direct patient care and assessing health capacity needs in the context of a cholera response. Much of the volunteer work that Bhargava provided in Haiti revolved around studying current hospital capacity and gaps to be addressed immediately and on a long-term basis by future volunteers. Due to the recurring problem of cholera outbreaks after every natural disaster,
the Project HOPE team, which included Bhargava, decided to build a fully stocked and freestanding cholera treatment center for the long term. The team also assessed the health capacity needs of St. Therese Hospital for staffing and training based on their observations. Bhargava recently moved from Milwaukee to Crosby, Minn. to begin work as director of Hospitalist Services at Cuyuna Regional Medical Center. While living in Milwaukee, he volunteered once a month at the Greater Milwaukee Free Clinic where he provided care to the working poor who did not qualify for insurance or state assistance. Many of these people had chronic conditions that were untreated. He was involved with the clinic from its inception in 1995. The clinic is staffed entirely by volunteers and relies on donations for supplies. According to Bhargava, “The clinic has helped those in dire need and those who have fallen through the cracks in the system by providing millions of dollars’ worth of care without any government support.”
WHO’S A BIGGER BASEBALL FAN, YOU OR ME? You’ll find that people with Down syndrome have a passion for knowledge and learning that can rival anyone you’ve met before. To learn more about the rewards of knowing or raising someone with Down syndrome, contact your local Down syndrome organization. Or visit www.dsamn.org today. It is the mission of the Down Syndrome Association of Minnesota to provide information, resources and support to individuals with Down syndrome, their families and their communities. We offer a wide range of services, programs and materials at no charge. If you are interested in receiving one of our information packets for new or expectant parents, please email Kathleen@dsamn.org or For more information please call:
(651) 603-0720 • (800) 511-3696
©2007 National Down Syndrome Congress
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
HEALTH CARE POLICY
Political divisiveness in health care Learning to work together By Ed Weisbart, MD
ou wouldn’t know it by looking at the health care debate in America today, but one of our nation’s foundational pillars used to be political collaboration. We have a proud legacy of collaboratively solving our problems despite our differences, and many of our past solutions were made stronger because of our differences. I have had the honor of testifying on a variety of topics in a number of state legislatures. My experiences make me wonder how
our noble national history led to political statements such as these that were said directly to me: • From a cattle rancher serving as a state representative: “As a former embryo, I have expertise about women’s reproductive choices.” This was the basis for his ignoring medical evidence about conception, embryology, and the guidance of the American College of Obstetrics and Gynecology. It’s difficult to build an evidence-based strategy with a legislator who believes his personal history as an embryo gives him as much information about reproductive issues as being board-certified in ob-gyn. • From an attorney serving as a state representative: “I oppose raising the tax on cigarettes because you can’t assure me the money won’t be used to clone humans.” It’s hard to determine the best strategy to prevent adolescent tobacco addiction without also having to weigh the risks and merits of stem cell research. • From a psychiatrist serving as a state senator: “I think about all 12 antidepressants, and I think about my patient, and something inside me moves and tells me which one to prescribe.” I was a bit worried about what might be moving inside of him, but held my tongue in the interest of finding common ground. • Finally, from another attorney serving as a state senator: “I acknowledge your evidence that expanding Medicaid would save many lives, but as a state senator I’m still going to block it for political reasons.” At least this senator was willing to be open and direct. How did we get to the point where reproducible evidence is valued as highly as uninformed conjecture, where attitude and philosophy are considered as independent truths, and politics trumps science, even for professionals? And how do we get back to building public policies based on evidence, reason, and collaboration?
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
A history of collaboration We have a long history of working together, from the compromises that gave us our Constitution to the bipartisan work that led to the passage of Social Security and Medicare. In 1984, the Hatch-Waxman Act struck another bipartisan balance between economically entrenched polarities. It extended patent periods for brand-name drugs, but also benefited consumers by speeding the approval process for generic equivalents, boosting generic drug utilization from 19 percent to 90 percent. This contentious, groundbreaking, and ultimately transformative bill, co-written by a Republican from Utah and a Democrat from California, reminds us where we once were and how far we’ve drifted off course. We need to return to that place of civil discourse where we were united by evidence and purpose, and not divided by party. We need to relearn how to respect those with whom we disagree, how to find common ground, and how to collaborate in building the necessary innovative solutions for today and tomorrow. Understanding political polarization Fortunately, there is a body of research that can help us better understand each other. Jonathan Haidt, social psychologist and professor of ethical leadership at New York University’s Stern School of Business, describes what he calls “moral foundations theory” in his 2012 book, “The Righteous Mind: Why Good People Are Divided by Politics and Religion.” The book shows how five moral values (fairness, caring, loyalty, authority, and sanctity) correlate with positions on the political spectrum, and illustrates why it’s so easy for us to unintentionally disrespect each other.
Examining the use of language The century-old movement for universal access to health care demonstrates how these moral values can help us find the elusive common ground. Statements such as, “Everybody in, nobody out,” or “Health care is a right, not a privilege,” resonate strongly with liberals because they activate core liberal values of caring and fairness. At the same time, these statements unwittingly distress many conservatives for whom these phrases suggest an undeserved entitlement, divorcing actions from consequences, enabling weakness, undermining individual responsibility, and exacerbating the moral hazard that leads to unhealthy personal decisions. A less-polarizing statement for the desired goal of health care reform might be, “The best health care in the world, efficiently delivered.” This statement elicits both liberal and conservative frames, with an emphasis on the liberal value of caring, equally paired with more conservative values of loyalty, authority, and sanctity. Analyzing progressive talking points Four common progressive talking points can inadvertently offend conservatives. Let’s walk through these, apply the lessons of Haidt’s research, and look for the common ground. Political divisiveness in health care to page 31
One of our nation’s foundational pillars used to be political collaboration.
According to Haidt, liberals tend to endorse both fairness (reciprocal altruism, justice, rights, and autonomy) and caring (empathy, kindness, gentleness, and nurturance). Conservatives endorse these values with less enthusiasm, but additionally endorse three other values: loyalty (patriotism and self-sacrifice), authority (deference to leadership and respect for traditions), and sanctity (the notion that bodies are temples desecrated by immorality). Liberals, thus, often see conservatives as inadequately sensitive to the demands for fairness and caring. Conservatives, on the other hand, see liberals as immorally deficient in loyalty, authority, and sanctity. Failure to respect these differences can undermine collaboration.
MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Reducing health disparities Data is the key By Jim Chase, MHA, and Anne Snowden, MPH, CPHQ
ave you been asked recently at your doctor’s office to share your race or country of origin? Ever wonder why? Health care outcomes vary widely based on where a person lives, their race, preferred language, or country of origin. To reduce and eliminate these barriers to health equity, we must understand where they exist and their scope—and your input could help. Here at home Minnesota is one of the healthiest states in the nation. On a variety
of indicators, from insurance coverage to life expectancy to the overall quality of care available from health providers, Minnesota ranks at or near the top of the country. But Minnesota also has some of the biggest disparities in health status and incidence of chronic disease between whites and people of color, those with language barriers, and new immigrants. For example, African Americans in Minnesota have a 20 percentage point lower rate than whites for colon cancer screening, a test that saves thousands of lives in our state each year. Communities of color and immigrant populations in Minnesota also experience significantly higher rates of chronic and infectious diseases, illness, and premature death. The Minnesota State Demographic Center predicts that the percentage of Minnesota’s population that is nonwhite and/or Latino is projected to grow from 14 percent in 2005 to 25 percent in 2035. The impacts of these health inequities affect all Minnesotans, in the form of diminished work and school performance, unemployment, crime, and increased health care costs. A major barrier to reducing these disparities has been the lack of comparable information across physician practices about the health outcome for patients from different backgrounds. Many doctors and nurses know it is not enough to treat everyone the same regardless of their race or social circumstance. Instead, they must understand the patient’s special needs in order to help them get the best results from their care. Information on a patient’s race and ethnicity helps medical groups develop and evaluate programs to address and eliminate health disparities. Collecting the numbers Minnesota Community Measurement (MNCM) collects and disseminates information in support of that goal. The non-profit organization coordinates with physicians, health plans, community organizations, consumers, and employers to help medical groups and communities reduce health disparities. On the patient side, MNCM publicly reports quality of care at clinics throughout
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Minnesota. Physicians and care teams tend to be quite competitive and want to provide the very best care for their patients. When their clinic scores are displayed from high to low along with all others throughout the state, they have additional motivation to improve care. In 2009, MNCM spearheaded a community-wide effort to develop a “Handbook on the Standard Collection of Race, Ethnicity and Language (REL) Data for Medical Groups.” Today, nearly every medical group in Minnesota collects REL data elements from patients. Medical groups pair this REL information with their quality-of-care measures, such as information on how well their patients meet treatment goals for diabetes and asthma care, to identify and implement changes to reduce disparities. Based on this statewide effort to collect REL data, MNCM produces its annual “Health Equity of Care Report,” which pinpoints distinct differences in health care outcomes between patient populations and geographic regions in Minnesota. (Look for the latest report at mncm.org/health-equity-of-care-report/).
Minnesota…has some of the biggest disparities in health status and incidence of chronic disease.
• Patients who preferred speaking Hmong, Somali, and Spanish generally had lower screening and care rates compared to other preferred language groups. Why does this matter? We all seek the American dream of “life, liberty, and the pursuit of happiness,” but these ideals can be more difficult for some populations to achieve. Health status can be a barrier for many people in achieving their dreams, and health status can be impacted by income, education, availability of health insurance, work hours that leave little time for medical appointments, transportation and language challenges, environmental risks based on residence, and the stress of caring for other family members. In addition, bias based on race or other factors can impact health care. All of us face a few of these issues from time to time, but some populations face multiple issues more often and for longer periods of time than others. Inequity in health outcomes is enough in itself for many people to want to take action, but we can also acknowledge that a poorer health status for a growing part of our population also means a less productive work force. And we know poor health can lead to other social problems such as poor school performance, higher unemployment, and more crime.
Reducing health disparities to page 30
Reporting the numbers As the old adage goes, “what gets measured gets managed.” Without specific measurement, disparities can go unnoticed by health care organizations—even as they seek to improve the quality of care for all patients. Among the specific measurements reported in MNCM’s latest report: • White patients generally had better health care outcomes across most measures and most geographic areas. • Patients in Greater Minnesota overall had poorer health outcomes than patients in the 13-county Metro area. • Patients born in Asian countries tend to have better outcomes across multiple quality measures and geographic regions than patients in other country-of-origin groups. • Generally, patients from large medical groups in the Metro area had higher rates of optimal care. • Across measures and geographic areas, American Indian or Alaska Native and Black or African American patients generally had the lowest health outcomes, both statewide and regionally. • Hispanic patients generally had poorer health care outcomes than non-Hispanic patients across all quality measures and most geographic regions. • Patients born in Laos, Somalia, and Mexico generally had poorer outcomes than other groups. MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Reducing health disparities from page 29
Acting on the data Health care providers use data from the “Health Equity of Care Report” to compare themselves with peers and to focus on improvements. Some local medical groups now build community partnerships to expand their care teams, provide training and awareness to their staff, offer financial incentives to their top leadership and individual care givers to reduce disparities, try new outreach and education to certain patients, address language and transportation barriers, provide flexible clinic hours, conduct patient risk assessments, and simply spend a bit more time answering patients’ questions. Understanding each patient’s individual needs and “meeting people where they’re at” can be more effective than a one-size-fits-all approach. Some patients need extra support at times to achieve better health outcomes. While these initiatives are notable, achieving health equity may require more creative approaches for specific populations of patients. One medical group, for example, boosted early screening rates for colon cancer among its African American patients by 27 percent through targeted use of its electronic health records. Since 2014, the colon cancer screening rate for all African American patients increased by 3 percentage points—the greatest increase among all populations of color. This translates to more than 4,300 additional African
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
American patients getting live-saving colorectal cancer screening. Conclusion Dr. Martin Luther King, Jr. said, “Of all the forms of inequality, injustice in health care is the most shocking and inhumane.” We have made great strides in addressing health inequity in Minnesota, but there is much more to be done. Improving performance rates for all patients requires a thorough examination of data at a medical group or clinic level in addition to data at national and state levels. When results are reported at a medical group or clinic level accountability, actions are more likely to be identified and used to address disparities. Disparities within the health care system impact everyone. Improving health equity will require continued measurement and reporting to identify, understand, and effectively meet the unique needs of each patient. Jim Chase, MHA, president of Minnesota Community Measurement (MNCM), serves on the boards of the National Quality Forum, the Institute for Clinical Systems Improvement, and the Network of Regional Healthcare Improvement, and is on the County Health Rankings Scientific Advisory Board. Anne Snowden, MPH, CPHQ, is director of measurement, validation, and reporting at MNCM. She launched the organization’s first-in-the-nation “Health Care Disparities Report” and produces the “Health Equity of Care Report.” She provides leadership support to MNCM board committees, including the Health Equity Advisory Council.
Political divisiveness in health care from page 27
The importance of respect While we have always faced challenges and struggles, we are now
Universal access to health care taps into liberal values of fairness and caring. Conservatives don’t generally disagree with this goal, but are equally concerned about the implications for their other moral values. When presented only through the liberal lenses of caring and fairness, some conservatives worry that an entitlement to health care could be corrosive to the moral imperative for individual responsibility, or that granting broader access to health care can undermine access for the group to which they themselves are the most loyal. Conservatives may thus see a conflict between their values of fairness/caring as opposed to loyalty/sanctity, a conflict to which liberals are often blind. Haidt’s data could guide us toward a different discussion about universal access to health care, one that better resonates with the moral values held by many conservatives: • Preventable premature deaths caused by a lack of universal access to health care is a violation of the conservative moral value of sanctity. This is a moral value of lower relative priority to many liberals, who typically center discussions about health care access on fairness and caring, and infrequently as an issue of sanctity. • Enhancing your community’s health should tap the conservative moral value of loyalty. The issue becomes one of defining your community as the entire nation.
at a high-water mark of disparate points of view, and we’re finding it increasingly difficult to listen to and understand each other. More important than the fleeting issues of electoral politics, more
We need to return to that place of civil discourse where we were united by evidence and purpose, and not divided by party.
important than the issues related to reforming our national health insurance strategy, the fabric of our democracy must be preserved and strengthened. Only by understanding and regaining the respect for—and the respect of—those with whom we disagree can we move forward toward solving our growing national health care problem. Ed Weisbart, MD, is a family physician in St. Louis, MO. He volunteers in a variety of safety net clinics, and chairs the Missouri chapter of Physicians for a National Health Program.
• The large body of faith-based leaders advocating for universal health care aligns with the conservative moral value of authority. Eliminating financial barriers to care (copays, deductibles, etc.) resonates with liberal values of caring and fairness. Again applying Haidt’s data, this part of the discussion could also resonate with conservative values of sanctity (no one’s health should be compromised because they can’t pay for care) and loyalty (every American should be able to get health care). Stabilizing the nation’s costs resonates with the conservative values of sanctity (we should be good stewards of resources) and loyalty (draining business resources through excessive insurance overhead weakens America). It also resonates with the liberal values of caring (wasting health care money undermines other important social programs) and fairness. Restricting choice of physicians and other providers offends those at all points on the political spectrum. Losing control over these choices is a clear violation of sanctity, and a healthcare system wherein insurance companies contradict physicians’ recommendations is a violation of the authority value. When either side believes it alone holds the “moral high ground,” it has already lost the argument. Throughout history, our greatest social advances have come from listening to and respecting, not demonizing and alienating, each other. MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Psychiatric medications from page 15
sufficient management of psychiatric symptoms without removing the incentive. With diligence to developing and utilizing skills taught in therapy, psychiatric medications may eventually be decreased. How do these medications work? Our understanding of mental illness and treatment is still evolving, as is our understanding of all illnesses and their treatments. What is known and understood regarding the brain processes of mental illness and the impact of psychiatric medications on brain chemistry is quite fascinating, but may seem daunting to those outside the scientific and medical communities. I try to present some basic concepts about how medications can impact the brain before discussing the rationale for choosing one particular medication instead of another. One approach is to compare the brain’s communication system to our personal communications with other people through emails. Our brain cells, or neurons, employ neurotransmitters (serotonin, dopamine, and norepinephrine, to name a few) to communicate with other neurons, just as we use Hotmail, Gmail, or Yahoo to communicate with other people. Various psychiatric illnesses involve a disruption in these “brain emails.” The messages may not reach the intended target brain cells, or the incoming messages may
overpower the neuron’s “inbox.” In either case, these disruptions can interfere with the brain’s normal mechanisms to manage anxiety, depression, stress, and other factors that affect our mental health. Psychiatric medications can correct these disruptions in the brain’s messaging system. Some antidepressants, for example, may be used to increase the serotonin email communication between the neurons. Other psychiatric medications may optimize the dopamine or norepinephrine emails between brain cells. Various psychiatric medications will accomplish their “fix” of these email disruptions in different ways. Summing up Psychiatric medications can work effectively with the brain’s chemistry to manage and control symptoms and relieve suffering, but it’s critical to consider multiple factors in prescribing a particular medication, and to continue seeking alternatives if the first medication proves ineffective. These sample discussions underscore the need to help patients understand how medications work and to engage them more fully in treatment decisions. It is an approach that my patients have come to value in seeking psychiatric care.
Marie Casey Olseth, MD, is a board-certified psychiatrist practicing at the West End Consultation Group in St. Louis Park.
MAY 2017 SURVEY MINNESOTA HEALTH CARE CONSUMER ASSOCIATION Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our healthcare delivery system. There is no charge to join the association, and everyone is invited. 2. I support legislation to expand the availability of generic drugs and biosimilar biological products. 60
25 20 15 10 5 0
4. The U.S. Food and Drug Administration (FDA) should provide the public with better statistical data on the efficacy of prescription medications.
20 10 Strongly Agree
40 Percentage of respondents
Percentage of respondents
5. I believe that insurance companies should cover genetic testing to help determine which medications will best meet the needs of patients.
50 40 30 20 10 0
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
35 30 25 20 15 10 5 0
3. I believe that legislators should do more to control the costs of prescription medications.
Percentage of respondents
35 Percentage of respondents
Percentage of respondents
1. I, or someone I know, has faced significant financial hardship due to the high cost of prescription medications.
40 30 20 10 0
For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.
Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community. Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.
www.mnhcca.org MAY/JUNE 2017 MINNESOTA HEALTH CARE NEWS
Joint replacement surgery from page 13
To help with the rehabilitation process, we have moved to multimodal pain management. Spinal anesthesia or a peripheral nerve block manages pain during the surgery, eliminating the need for stronger anesthesia medications. This leads to less fatigue, nausea, and confusion following surgery, and, as an added bonus, the effects usually last through the day following
You are usually up and walking within hours after surgery.
surgery and provide pain relief during the early recovery phase. Local injections of long-acting numbing medicines around the hip or knee joint provide additional pain relief. After surgery,
The value of joint replacement surgery Every surgical procedure involves some risks, but the outcome data on joint replacement surgery is very reassuring. Joint replacement surgery is one of the safest and most effective surgeries you can have; 90 to 95 percent of patients with a hip or knee replacement report an excellent outcome. These surgeries help people to maintain vibrant, healthy lives and to avoid health issues related to inactivity. Restrictions following these procedures are minimal, and allow patients to return to many high level activities, including walking/hiking, golf, tennis, cycling, and even downhill skiing. Joint replacement surgery is an extremely valuable option for patients with severe arthritis that is not managed by conservative treatments. I encourage patients to assess treatment choices based on many factors, including: symptoms, lifestyle expectations, activity level, and nutrition. Discussing your condition and your health care choices with your orthopedic specialist can give you the confidence and comfort of understanding which options will work best for you.
the multimodal approach continues with multiple prescription medicines
nausea medications, and, at times, muscle relaxants and nerve medications. This combination allows for minimizing the use of stronger narcotic medicines and the unwanted side effects that come with them.
MINNESOTA HEALTH CARE NEWS MAY/JUNE 2017
Dane Hansen, DO, is an orthopedic surgeon with Summit Orthopedics in St. Paul, specializing in hip and knee arthritis and joint replacements. He completed a fellowship in adult joint reconstruction at Rush University Medical Center in Chicago, which focused on minimally invasive joint replacement techniques as well as complex revision joint surgery.
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].
for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013
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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8
mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested
Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits
Reductions up to -1.1%a
Weight loss up to 5.5 lba,b
Low rate of hypoglycemiac
1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a
A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.
The change begins at VictozaPro.com. Indications and Usage
Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin. ®
Important Safety Information
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%). Please see brief summary of Prescribing Information on adjacent page. 1013-00018617-1
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