August 2016 • Volume 14 Number 8
Preparticipation physical evaluations By William O. Roberts, MD, MS, and Lori Glover, MHA, MS, ATC
Heart failure By Mosi Bennett, MD, PhD, and Terri Arndt, RN, MA, CCRC
Trauma centers By Jonathan C. Gipson, MD, FACS, and Melissa A.L. Thorson, MS, APRN, CCNS
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CONTENTS
4 7 8
AUGUST 2016 • VOLUME 14 NUMBER 8
NEWS
PEOPLE
PERSPECTIVE
Suicide Addressing a serious public health problem
14
MINNESOTA HEALTH CARE ROUNDTABLE
C CARDIOLOGY
Heart failure A look at common symptoms and treatments
FORTY-SIXTH SESSION
By Mosi Bennett, MD, PhD, and Terri Arndt, RN, MA, CCRC
16 18
CALENDAR
Value - Based Reimbursement:
A new way to pay for health care
MINNESOTA HEALTH CARE ROUNDTABLE
M edical innovation vs. medical economics
By MPP Staff Dan Reidenberg, PsyD Suicide Awareness Voices of Education
10
10 QUESTIONS Living with chronic pain
26
REHABILITATION
Physical therapy Participate in your own recovery
By Jennifer Missling, MS, PT, ATC
28 David Schultz, MD Medical Advanced Pain Specialists
12
Trauma centers
Saving lives when seconds count
y Jonathan C. Gipson, B MD, FACS, and Melissa A.L. Thorson, MS, APRN, CCNS
PEDIATRICS
Preparticipation physical evaluations A requirement for high school athletes
EMERGENCY MEDICINE
30
TAKE CARE
Food poisoning A look at the By William O. Roberts, common causes MD, MS, and Lori Glover, MHA, MS, ATC By Stephanie Meyer, MPH
Thursday, November 3, 2016 • 1:00-4:00 PM
The Towers The Gallery Gallery (lobby level), Downtown Minneapolis Hilton and Towers
Background Background and Focus: As initiatives driven by federal health care reform is reform move forward, the term “Value-Based Reimbursement” (VBR) is being mean? being applied to a wide spectrum of issues. But what does this mean? CMS what CMS is developing measurements, well over 150 to date, to define what “value” be “value” means in health care. It is proposed that these metrics will be used element used to create incentives that pay more for better care in every element of and of health health care delivery. Hospitals, physician practices, home care, and long-term long-term care will all be reimbursed by an emerging new math. Objectives: Objectives: We will explore the motivations behind this changing approach approach to reimbursing health care. We will examine what is being being measured and what value really means. We will discuss the arguments arguments that claim VBR is a bad idea and those that believe it is the the best solution. We will discuss how a collaborative, transparent system, and system, that integrates care teams, health information technology and improved access improved reimbursement methods will help achieve increased access to to high-quality, high-quality, cost-effective care for patients. Panelists Integration Panelists include: • Don Flott, Director of Utilization and Integration Services, Services, Mayo Medical Laboratories • Allison LaValley, Executive Director, Practice Director, athenahealth • David Melloh, JD, Chair, Health Law Practice Group Group at Lindquist & Vennum LLP Sponsors Sponsors include: • athenahealth • Mayo Medical Laboratories •• Lindquist Lindquist & Vennum LLP Please tickets at $95.00 per ticket. Tickets may be ordered ordered Please send me by website by phone phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub.com), Physician (mppub.com), or by mail. Make checks payable to Minnesota Physician Publishing. 55406. Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please Please note: tickets are non-refundable.
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AUGUST 2016 MINNESOTA HEALTH CARE NEWS
3
NEWS
Agencies Reveal Five-Year Plan to Fight Antibiotic Resistance Four Minnesota agencies have partnered to launch a five-year plan to combat antibiotic resistance and keep antibiotics effective. The Minnesota Department of Health (MDH), Minnesota Department of Agriculture, Board of Animal Health, and Minnesota Pollution Control Agency are working with other community partners in public health, health care, agribusiness, environmental protection, pharmaceutical companies, and other fields to “promote judicious antibiotic use and stewardship in order to reduce the impact of resistant bacteria,” according to a statement from MDH. The Centers for Disease Control and Prevention estimates that antibiotic resistant bacteria cause 2 million illnesses in people and 23,000 deaths each year and that up to half of antibiotic use in hospitals is unnecessary or inappropriate, while
4
more than half prescribed to outpatients are unnecessarily prescribed for upper respiratory infections. “Unless we can find ways to preserve the effectiveness of the antibiotics we have and slow the development of resistance to new antibiotics, we may again see increased numbers of illnesses and death due to our inability to control bacterial infections,” said Ed Ehlinger, MD, Minnesota commissioner of health. “Antibiotics are critical public health tools. Their effectiveness can and must be preserved. This can be done through judicious use and diligent stewardship.” The four agencies formed the One Health Minnesota Antibiotic Stewardship Collaborative and had their first summit in January. The themes discussed at the summit formed the basis for the newly released five-year plan, which has four main goals and associated activities. The goals focus on the idea that the health of people, animals, and the environment are interconnected. They hope to improve human antibiotic stewardship efforts by developing a roadmap and
MINNESOTA HEALTH CARE NEWS AUGUST 2016
incentives for health care facilities and improve animal antibiotic stewardship efforts by supporting data collection on antibiotic use, livestock farmer quality certification programs, the veterinary feed directive, lab testing, and resources for those working with companion animals. To improve understanding of environmental issues, they will develop a tool to measure the impact of antibiotics agriculture on the environment and advocate for better disposal methods.
Seniors Covered by Integrated Program Have Better Health Outcomes A study commissioned by the U.S. Department of Health and Human Services has found that Minnesota seniors served by the Minnesota Senior Health Options (MSHO) program, which combines Medicaid and Medicare benefits, have better health outcomes than those served by Minnesota Senior Care Plus, a Medicaid-only program.
“This study affirms the value of what we have been doing in Minnesota for almost two decades,” said Emily Piper, human services commissioner. “We hope that other states can learn from our experience as they work to better serve low-income seniors.” Researchers looked at three years of data for the MSHO program, which serves about 36,000 older adults eligible for Medicare and Medicaid. They compared outcomes to those for Minnesota Senior Care Plus, which covers about 14,000 seniors. Between 2010 and 2012, seniors served by MSHO were 48 percent less likely to be admitted to a hospital compared to those served by Minnesota Senior Care Plus. For MSHO enrollees who were hospitalized, about 26 percent had fewer hospital stays. MSHO enrollees were 6 percent less likely to visit an outpatient emergency department than those enrolled in Minnesota Senior Care Plus, and those who did visit an emergency room had 36 percent fewer visits. They were also 13 percent more
likely to receive home- and community-based long-term care services, 16 percent less likely to have any assisted living services, and 9 percent more likely to have any hospice care use. “Integrated care is improving the lives of some of the most vulnerable Americans,” said a statement about the study from the Centers for Medicare and Medicaid Services. “These new findings from Minnesota affirm the promise of integrated care and reinforce the urgency with which we need to continue to develop, test, and scale successful models for better serving dually eligible individuals.”
Abortion Rates Continue to Decline The rate of induced abortions in Minnesota has fallen, continuing a steady decline over the past decade, according to an annual report from the Minnesota Department of Health. There was a 2.5 percent decrease in the number of abortions in the last year, from 10,123 in 2014 to 9,861 in 2015. The 2015 rate is the lowest recorded rate since 1974. “The number of abortions in Minnesota continues to decline and that tells us that access to birth control and sex education is working,” said Sarah Stoesz, president and CEO of Planned Parenthood Minnesota, North Dakota, South Dakota. “Planned Parenthood works every day to make sure women and young people in our state have access to birth control and medically accurate information about their health so they can make informed decisions.” More than 11,600 women received information from the state about abortion risks, complications, and alternatives under the Women’s Right to Know law that passed in 2003—1,692 more than the number of women who underwent abortions. Of the abortions performed in 2015, 246 were performed on minors, accounting for 2.5 percent of the total. That rate represents an 89 percent decline from its peak of 2,327 in 1980, the year before the passage of Minnesota’s Parental Notification law, and is the lowest since the state began recording minor abortions in 1975. More than 40 percent of abortions in 2015 were performed on women who
had undergone at least one prior abortion—703 of those women had three or more previous abortions and 88 women had six or more previous abortions. Late-term abortions, performed after 20 weeks, increased from 97 to 122, and the latest was performed at 29 weeks. In 2014, the latest was performed at 27 weeks. The reasons women gave for undergoing abortions included rape or incest (less than 1 percent); “does not want children at this time” (70 percent); and economic reasons (26 percent), all with little to no change from last year. Other reasons included financial situations, health-related reasons, and fetal abnormalities. The rate of abortions used as birth control (no contraception used at the time of conception) increased from 61 percent in 2014 to 65 percent in 2015.
HCMC Named Medical Services Provider of U.S. Bank Stadium
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612.379.1370 | catholiceldercare.org Hennepin County Medical Center (HCMC) has partnered with the 149 8th Avenue NE, Minneapolis, MN 55413 Minnesota Sports Facilities Authority to become the exclusive medical service provider for U.S. Bank Stadium, which opened in July. HCMC 67311 CE TCU Ad_MN-Physicians_4x5.25.indd 1 paramedics and emergency medical response personnel will provide first Have pain due to aid and other medical care needs for participants and fans at Vikings games and other major events at in a hip or knee joint? the stadium. If hospitalization is necessary, patients will be taken to HCMC’s main campus, located a block away from the stadium.
6/30/16 3:44 PM
OSTEOARTHRITIS
Blue Cross to Reduce Individual Health Care Plans The state’s largest health care insurer, Blue Cross and Blue Shield of Minnesota, has announced that it will reduce its offerings in the individual market starting in 2017 due to financial losses. The insurer reported a loss of $265 million on insurance operations from individual market plans last year. “Shifts and changes in health plan participation and market segments
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News to page 6 AUGUST 2016 MINNESOTA HEALTH CARE NEWS
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News from page 5
have contributed to a volatile market, where costs and prices have been escalating at unprecedented levels,” Blue Cross said in a statement. “Based on current medical claim trends, Blue Cross is projecting a total loss of more than $500 million in the individual segment over three years.” Blue Cross will continue to offer plans on the individual market through its smaller subsidiary, Blue Plus, which has about 13,000 members. However, these plans have a narrow network and restrict the hospitals, doctors, and prescription drugs a patient can access. The change will affect about 103,000 Minnesotans who have purchased coverage through Blue Cross on their own, through MNsure, or through an agent or broker. Blue Cross plans to notify members and work with them to find alternative coverage options for 2017. In response to the move, Gov. Mark Dayton said his administration will help enrollees affected by the change find new coverage for 2017.
“This creates a serious and unintended challenge for the individual market: the Minnesotans who seek coverage there tend to have greater, more expensive health care needs than the general population,” said Dayton. “Blue Cross Blue Shield’s decision to leave the individual market is symptomatic of conditions in the national health insurance marketplace.”
DHS Awards Grant to Provide Food to Low-Income Families The Minnesota Department of Human Services (DHS) has awarded a $250,000 grant to Second Harvest Heartland, one of the largest food banks in the U.S., to provide low-income families and individuals better access to nutritious foods. The grant is part of a $45 million State Innovation Model (SIM) grant awarded to DHS and the Minnesota Department of Health in 2013 by The Center for Medicare and Medicaid Innovation to help implement
the Minnesota Accountable Health Model. The funds will be used to help Second Harvest’s Food Security project, which will provide boxes of healthy food each month for people with diabetes and prediabetes at Allina Health clinics in Cambridge, Coon Rapids, North Branch, and St. Paul; monthly food boxes for people with diabetes and lipid metabolism disorder at CentraCare Family Health Center in St. Cloud; and an electronic system to identify and recruit families who need food assistance through Hennepin County Medical Center.
Minnesota Expands Newborn Screening Program The Minnesota Department of Health (MDH) has announced the addition of three disorders to the list of conditions that all newborns are screened for: mucopolysaccaridosis type 1, Pompe disease, and X-linked adrenoleukodystophy.
The disorders were recommended for screening at a national level and by Minnesota’s advisory committee. According to MDH, preliminary data from two states that already screen for these disorders (Missouri and New York) indicate that about five to 15 Minnesota children will benefit from the screening each year. The screenings are expected to begin in January 2017, bringing the total conditions Minnesota newborns are screened for to 60. “By adding these disorders to the newborn screening panel, we will be able to diagnose and begin treating these disorders much earlier, leading to much better outcomes for Minnesota’s newborns,” said Paul Allwood, MDH assistant commissioner. The disorders are all caused by an inherited genetic mutation and can cause bone abnormalities, muscle weakness, nerve impairment, hearing loss, respiratory failure, and heart failure. Left untreated, the disorders can be fatal. Early detection and treatment will lead to significantly improved outcomes for children affected by these disorders.
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UCare for SeniorsSM lets you choose from plans that cover prescription drugs, travel, eyewear, dental, fitness programs like Healthways SilverSneakers® Fitness and more. There are low or no co-pays for primary care visits with most plans. And you’ll get to talk to a real person 24/7 when you call customer service. It’s just what you’d expect from health care that starts with you. Learn more about the benefits of UCare for Seniors in our new eGuide to Medicare at ucareplans.org. Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534, 8 a.m. to 8 p.m. daily.
UCare for Seniors is an HMO-POS plan with a Medicare contract. Enrollment in UCare for Seniors depends on contract renewal. ©2015, UCare H2459_101512 CMS Accepted (10202012) MINNESOTA HEALTH CARE NEWS AUGUST 2016 6 UC693 2015 Boomer MPP MN Health Care News_Hippie.indd 1
9/14/15 9:03 AM
PEOPLE Marshall Smith has been named health systems chief executive officer in direct care and treatment at the Minnesota Department of Human Services. In his new role, Smith oversees state-operated facilities and programs that provide mental health treatment across the state, including a network of 16-bed community behavioral health hospitals, the Minnesota Security Hospital in St. Peter, and the Anoka-Metro Regional Treatment Center. He is responsible for leadership aimed at improving patient care and outcomes, enhancing and strengthening quality and compliance, and overseeing medical services. Smith has both clinical and administrative skills and has served in various executive roles in public, private, and non-profit hospitals and health care systems across the U.S. Most recently, Smith operated his own health care consulting business. He has a master’s degree in health care administration from Medical University of South Carolina. Leah Sams and Joe Grafft were recognized by the Anoka County Board of Commissioners with 2016 Public Health Awards for devoting their time, energy, and talent to improving public health in the community. Sams, biomedical sciences program coordinator at Coon Rapids High School, was recognized for successfully establishing a biomedical sciences program in area schools to encourage youth to enter professional health fields. Students have access to learning experiences with Leah Sams Mercy Hospital and Medtronic and opportunities to hear speakers and take field trips related to health care careers and earn college credits. Sams earned a master’s degree in teaching from the College of St. Scholastica. Grafft, CEO of Customized Safety Training, LLC, was recognized for leading efforts to establish emergency medical responder and emergency medical technician courses at Columbia Heights, Forest Lake, Fridley, and Spring Lake Park High Schools. Grafft has been a nationally registered emergency medical technician since 1974. He earned a master’s Joe Grafft degree in health and emergency medical services management from Mankato State University. Ann Sweeney, master pediatric nurse practitioner at NorthPoint Health and Wellness, has received the 2016 Professional Lifetime Achievement Award from the Minnesota Chapter of the National Association of Pediatric Nurse Practitioners (NAPNAP) for her significant contribution to the region promoting health care of children and families. Sweeney has worked as a nurse for 35 years. She earned her master’s degree in maternal child health from the University of Wisconsin. In Ann Sweeney addition, Cynthia Brady, DNP, pediatric nurse practitioner at Children’s Respiratory and Critical Care Specialists, received the Pediatric Nurse Practitioner of the Year award from NAPNAP for her contributions to improving care for children with special health care needs, including serving on the Cystic Fibrosis Foundation Guidelines Committee to develop evidence-based practice guidelines for children with the disease. Brady earned a docCynthia Brady torate of nursing practice and a master of science degree from the University of Minnesota.
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PERSPECTIVE
Suicide Addressing a serious public health problem
S
uicide is a word no one wants to hear. September 10th is World Suicide Prevention Day, making it a good time to learn what you can do to prevent suicide.
Striking all demographics
Dan Reidenberg, PsyD Suicide Awareness Voices of Education Dr. Reidenberg is the executive director of Suicide Awareness Voices of Education and the U.S. Representative appointed to the International Association for Suicide Prevention. He is a board-certified professional counselor, certified master therapist, and diplomate and fellow of the American Psychotherapy Association. An author, international speaker, and media authority, Dr. Reidenberg serves on multiple journal editorial boards, and created an evidence-based suicide program. Dr. Reidenberg has received numerous awards and was named a Champion of Change by President Obama.
How big is the problem? In 2014, the Centers for Disease Control and Prevention (CDC) ranked suicide as the 10th leading cause of death among Americans of all ages. It is the second leading cause of death for youth ages 10–24, the third for young adults, and the fourth for adults ages 35–54. CDC data showed a 24 percent increase in suicides from 1999–2014, with the pace of increases rising after 2006. There is one suicide every 12 minutes; one person is hospitalized for an attempt every 29 seconds; and there are over 1 million attempts each year. In 2014, we lost 42,773 lives to suicide in the U.S. (686 in Minnesota)— more than breast cancer, car accidents, DWIs, and AIDS. Suicide occurs among all demographics throughout the world. Suicide deaths are four times higher among males, but females are more likely to have suicidal thoughts, and attempt suicide three times more often than males. The highest rates of U.S. suicides are among Caucasians, American Indians, and Alaska Natives, although recent data show an increase in African American males, and Latina youth have high rates of attempts. Geographically, those in rural areas tend to have higher rates of suicide. Bottom line: suicide is a real and serious public health problem.
Questions and answers
What’s behind suicide? Ninety percent of those who died by suicide had a psychiatric illness at the time of their death. Sometimes undiagnosed or misdiagnosed, mental illnesses are a key underlying factor in suicide. Substance abuse elevates this risk: approximately 33 percent of people have alcohol in their system at the time of their death. Prior suicide attempts are the greatest known risk factor for a completed suicide, as the risk of suicide is greatest in the first 60 days after an attempt. Other contributing factors include chronic pain, Post Traumatic Stress Disorder (particularly among military personnel, veterans, and those suffering violence and abuse), inadequate coping skills, and impulsivity and ready access to lethal means (e.g., firearms, ropes and sharp objects, automobiles, and pills and poisons). Media coverage and memorials may also impact other suicides. Why don’t people get help? Stigma, shame, and embarrassment prevent some people from seeking help. From military personnel fearful of losing their rank, to
8
MINNESOTA HEALTH CARE NEWS AUGUST 2016
business people afraid of their supervisor’s reaction or their prospects for promotion, to spouses afraid that their partners will leave them: fear stops people. Another barrier to seeking help is the (false) belief that nothing can be done to help them. Many people (men in particular) fail to seek help out of a belief that they can do it on their own. Finally, many simply do not know where to go, what to ask for, or how to pay for treatment. How can I prevent a suicide? Start by taking five minutes to learn about suicide. Two key warning signs: communicating an intent to die (talking directly or indirectly about suicide and death, expressing feelings of unbearable pain that won’t go away, and having no hope and no purpose for living) and looking for a way to die (searching online for suicide methods, looking for guns or sharp objects). Uncharacteristic changes may also provide a first clue of increased risk. Talk with loved
If you or someone you know is thinking about suicide, act now; later might be too late.
ones or colleagues about these changes, and ask about suicide. It is safe, and you won’t put the idea in their head. If they acknowledge suicidal thoughts, it’s critical to encourage them to seek help. Stress that there is hope and that you care, as people having thoughts of suicide lose hope. The more you can help them see alternatives and options, the greater the chances that will begin to see hope again. If there is an imminent threat of suicide, call 911 or go to the closest hospital. If you are not sure what to do, call the National Suicide Prevention Lifeline (800273-8255), a confidential and free service that connects you with a crisis center in your community. Most county social services departments provide Mobile Crisis Outreach Teams. For information on suicide prevention and resources for bereavement, visit www.save.org. To learn about warning signs and prevention, visit www.youthsuicidewarningsigns.org (focused on youth) or www.Take5ToSaveLives.org (warning signs and prevention for adults). If you or someone you know is thinking about suicide, act now; later might be too late. You don’t have to be a doctor, and you don’t have to do this alone.
OCTOBER 15, 2016
FR
9am – 3pm
EE
EV
Minneapolis Convention Center 1301 2 Avenue South, Hall E Minneapolis, MN 55403 nd
EN
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Learn how to be healthy, active and live well with diabetes Make Healthy Food Choices
• Cooking demonstrations • Healthy food sampling • Tasty and healthful recipes
Get Active
• Learn how to work fitness into your everyday life • Fitness demonstrations • Exercise tips
Free Health Screenings • • • • • • • • •
A1C Stroke Risk Assessments Blood Pressure Foot Screenings Diabetes Risk Assessments Eye Screenings BMI (body mass index) Oral Cancer Screenings Kidney Screenings
Ask the Expert
Come prepared with questions for health care professionals who can answer your diabetes questions one-on-one. Learn more about how to manage diabetes and prevent devastating complications.
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Interactive entertainment for the whole family.
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Look for areas within the exhibit hall featuring information tailored to meet the specific needs of you and your family.
Visit diabetes.org/expominneapolis to print a FREE Metro Transit pass to the event! Follow us for updates at: Facebook.com/ADA.Minnesota • Twitter: @DiabetesMN
For more info or to preregister: diabetes.org/expominneapolis or call 1-888-DIABETES ext 6592
AUGUST 2016 MINNESOTA HEALTH CARE NEWS
9
10 QUESTIONS
Living with chronic pain David Schultz, MD Dr. Schultz is the founder and medical director of Medical Advanced Pain Specialists (MAPS) Medical Pain Clinics and MAPS Applied Research Center. He is a board-certified anesthesiologist with additional board certification in pain medicine from the American Board of Anesthesiology, the American Board of Interventional Pain Physicians, and the American Board of Pain Medicine. How do you define chronic pain? Chronic pain is pain that persists beyond the normal course of healing. Pain is typically considered chronic when it has persisted for six months or longer, although this time designation is somewhat arbitrary. Physicians may see characteristic chronic pain in just three months, while acute pain stemming from injury, especially from orthopedic injury, can sometimes take longer than six months to resolve. Unlike normal pain, which warns and protects us from further injury, chronic pain serves no useful purpose and is a destructive force that can destroy quality of life.
10
MINNESOTA HEALTH CARE NEWS AUGUST 2016
Although pain-rating scales are commonly used, their validity is questionable and the pain specialist must consider the pain rating in conjunction with the nature of the structural problems causing pain, and the psychosocial-emotional disposition of the patient reporting the pain. Please describe the multidisciplinary approach to pain management employed by Medical Advanced Pain Specialists. At MAPS, we believe in combining minimally invasive, high tech pain interventions with medication management, physical therapy, and psychology-based treatments to provide comprehensive multidisciplinary care for the chronic pain patient. MAPS employs board-certified interventional pain physicians, specialized mid-level providers, physical therapists, and psychologists who work together to tailor pain management to the patient’s needs. How would patients know they have become addicted to opioids? Opioid addiction is a psychological condition characterized by abnormal focus on opioids associated with a loss of control in taking these medications. Opioid addicts change their behavior so that their life revolves around procuring and using opioids to create that sense of physical and mental well-being called a “high.” Addicts continue to use opioids despite negative consequences and tend to lie and deceive others to obtain opioids. Addicts typically have little insight into their addiction and often deny having any problems with drugs. Sometimes, family members and health professionals are the first to identify characteristics of addiction, and patients should seriously consider the observations of others when assessing their own drug use behavior. Whereas addiction is a psychological condition characterized by compulsive drug use behavior, physical dependence is a biological condition characterized by tolerance to opioid effects over time and withdrawal symptoms if opioids are abruptly stopped. In contrast to addiction, physical dependence is a physiologic adaptation of the body to the opioid and occurs in all patients to some extent. While all addicts are physically dependent, all physically dependent patients are not addicted.
What problems do patients have talking to their doctors about pain? Chronic pain is often frustrating for doctors as well as patients because diagnosis may not be forthcoming and best treatment is unclear. Doctors may sometimes feel frustrated dealing with patients who have chronic pain since the doctor is unsure how to manage the condition and the patient seems not to improve. The patient may misinterpret this frustration and believe that the doctor is uncaring and indifferent to their suffering. The end result is a vicious cycle where the patient becomes increasingly discouraged and the doctor becomes increasingly exasperated. When opioids are involved, the situation becomes more stressful. Doctors are often disinclined to prescribe opioids, and patients may feel like drug seekers. Pain is rated on a 1–10 scale. What does this mean? The 1–10 pain scale is called a numerical rating scale. Pain is, by nature, a subjective experience and there is no accurate “pain meter” that can be used to determine how much pain any particular patient is feeling. The numerical pain rating is based on the
patient’s self-report, and is therefore always subjective and dependent on a complex interaction of physical, emotional, and cultural issues.
photo credit: Greg Christensen
What interventions or referrals do you recommend if a patient has become addicted to opioids? Physicians specializing in addiction are called addictionologists, and these doctors have specialized training to evaluate and treat addiction. Chemical dependency counselors are not doctors, but they also have special training in addiction. Patients who believe they may be addicted should first discuss this with their primary care physician. If addiction is considered likely, referral to a chemical dependency program or addiction specialist is indicated. Addicted patients have several good treatment options, including alternative medication management, outpatient behavioral therapy, or an inpatient rehabilitation program.
How can patients with unrelieved chronic pain maintain their quality of life? Chronic pain patients can do best by working with pain specialists to accurately diagnose and effectively relieve physical pain to the greatest extent possible, by learning to live and cope better with pain that cannot be entirely relieved, and by maintaining active physical and social functioning despite pain.
Chronic pain serves no useful purpose and is a destructive force that can destroy quality of life.
How will Minnesota’s recent decision to allow medical cannabis for patients suffering from chronic pain affect physicians and patients? Health care providers are acutely aware of the epidemic of opioid overdose and death sweeping the U.S., and many believe that medical cannabis in well-selected patients will prove to be a safer alternative for pain management. Some doctors are concerned, however, that some patients on medical cannabis will continue to take opioids and will then be using multiple substances with addiction potential. The impact of medic al cannabis on opioid use remains to be determined and will require analysis of outcomes data over time as the Minnesota program continues.
Don’t Suffer Alone
How has the diagnosis and treatment of chronic pain changed over time? In the past, chronic pain was often considered an incomprehensible, permanent condition with no specific diagnosis or treatment. Today, with the evolution of advanced imaging, new minimally invasive interventions, and innovations in implantable pain control, doctors are able to accurately diagnose and effectively relieve chronic pain that was once considered untreatable.
When should a patient seek a pain medicine specialist? When pain is persisting despite routine primary medical care including time, rest, analgesics, and physical therapy, a physician pain specialist can often provide accurate diagnosis and effective treatment. Patients should request referral to a pain specialist if pain is severe, disabling, and lasting longer than expected, especially when prolonged courses of opioids are required for pain control.
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Call 1-800-333-HOPE • Or visit www.NorthstarProblemGambling.org AUGUST 2016 MINNESOTA HEALTH CARE NEWS
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PEDIATRICS
Preparticipation physical evaluations A requirement for high school athletes By William O. Roberts, MD, MS, and Lori Glover, MHA, MS, ATC
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his time of year, many organizations offer “preseason physicals” or “sports physicals.” But what exactly are sports physicals? Who needs them, and how often?
Making the team The preparticipation physical evaluation (PPE) is a periodic health evaluation required for Minnesota high school athletes to participate in sports. The exam is optimally completed by the athlete’s primary physician in an office setting with full access to the patient’s past medical record. The Minnesota State High School League (MSHSL) requires a PPE for each student athlete once every three years. A
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While the PPE is required for high school student athletes to participate in varsity program sports, students participating in club, middle school, or community-based sports will also benefit from the evaluation. Athletes participating in club or community sports should contact the governing body to determine their requirements for a PPE prior to starting practice and competition. Screening for risk The purpose of the PPE is to screen for conditions that may be life-threatening or disabling, as well as for conditions that may predispose a student athlete to injury or illness, not to exclude athletes from participation. These exams are not designed to take the place of the usual periodic health evaluation, but periodic exams can be incorporated into the health screening physical. The PPE has never been proven to benefit the health and safety of athletes, but there are many anecdotes relating to potentially lethal abnormalities uncovered during the exam. As an added benefit, a comprehensive PPE helps assess general health, serves as an entry point to the health care system for adolescents, and provides the chance to discuss health-related topics that put student athletes at risk away from the playing field. For many uninjured teens, this may be the only contact they have with a medical provider.
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health questionnaire is required during the off years, to determine whether any new health concerns have occurred between exams that would warrant further evaluation by a physician—for example, an injury in which the player nearly blacks out, or an actual concussion that has not resolved.
MINNESOTA HEALTH CARE NEWS AUGUST 2016
Although many practitioners are allowed to perform the examinations, the authors of the PPE Monograph—a joint initiative including six organizations involved in the care of athletes, children, and young adults—recommend that the examiners hold either a doctor of medicine degree or a doctor of osteopathic medicine degree with an unrestricted medical license, to ensure that they have the training to deal with the broad range of problems addressed during the PPE. Start to finish The PPE starts with an extensive questionnaire. Minnesota has been a leader in high school health screenings, and many across the country are catching up to the standards set here. The current version of the PPE questionnaire was released in the 2010 PPE Monograph. Some of the questions on the exam involve medical terminology for a specific diagnosis—like Marfan syndrome, long QT syndrome,
and hypertrophic cardiomyopathy. While these may not be commonly known terms, if an athlete has one of these conditions, the provider completing the exam needs to be aware of the condition to determine if it would put the athlete at risk while playing a sport. It is very important to answer all questions accurately and honestly. The integrity of the exam depends on honest answers from athletes and parents. Parents should help their children complete the form and double check it for accuracy, as they have valuable family information that the teen may not remember or know. The form is lengthy, but rushing through it or failing to fill it out accurately could lead to potential health issues.
team training. This is also an opportunity to discuss previous health issues and to get guidance for safety and health. Following the review of the questionnaire and the physical exam, physicians will complete an MSHSL clearance form indicating the student athlete’s fitness. The form may indicate that the student is fit to participate in all collision contact sports, limited contact sports, and non-contact sports; it could also exclude individual sports, exclude all sports, or require further evaluation. The form also assesses intensity and strenuousness based on a three-part scale. The completed form is valid for three years, subject to the results of subsequent annual health questionnaires.
The Minnesota State High School League (MSHSL) requires a PPE for each student athlete once every three years.
Each question has a specific purpose. There are several questions that relate to heart health, as sudden cardiac death in young athletes is devastating for families, teams, and schools. Family history and heart-related personal history questions provide valuable information for identifying conditions that may predispose an athlete to heart problems during activity. The PPE questions are reviewed annually by the MSHSL Sports Medicine Advisory Committee to allow for changes and updates. The new MSHSL standard is an online PPE questionnaire available through the commercial Privit platform. If their school uses this system, parents can enter all pertinent information into a “Privit Profile” for their student athlete, making health-related data readily available to those holding defined, variable levels of access. For example, Privit may allow coaches to quickly determine whether an athlete is allergic to bee stings, but it would not allow them to see the more confidential health-related information that is available to physicians. Privit Profile’s online questionnaire utilizes branch questioning: If a student answers “yes” to a question, other questions pertinent to the problem will display for a more in-depth look at the health issue. If the answer is “no,” the program moves on to the next question. When finished, the student can print off a report to bring in to the provider conducting the actual exam. The report is succinct and easy to read, giving the physician the information needed to guide the exam. The data is stored in a secure database and can be updated at any time. It is also available for the next required exam and can follow the student to college and beyond. Once it has been stripped of all personally identifiable information, Privit Profile data is also available under the ePPE database, which allows statewide analysis to assess the utility of the exam and help determine the optimum “questionnaire” for the health and safety of our student athletes. If you are not sure if the ePPE is available to you, contact your high school to see if they are using Privit Profile. The actual PPE physical exam is generally not a long process. There are no blood tests, no immunizations, and no X-rays or other imaging. If problems are identified that require additional investigation, a follow-up physician visit is warranted to determine clearance for activity. During the PPE, the student athlete will have a vision test; blood pressure, height, and weight measurements; and physical examination of the head, heart and cardiovascular system, lungs, and abdomen. They will also have a general assessment of joint range of motion and muscle strength. It is important for athletes to understand where they have strength and neuromuscular movement issues that may lead to overuse or acute musculoskeletal injury so they can correct imbalances or problems before the start of
Summary The PPE exam is intended to help athletes safely participate in sports. It is not intended to be a barrier to participation. The integrity of the exam and update process depends upon honest answers to the history screening questions from athletes and parents. The schools should require physician clearance following injuries that occur during the sports season. Health care organizations and providers offer PPEs throughout the year. If you need a PPE, contact your primary physician or clinic to schedule an appointment. William O. Roberts, MD, MS, is a professor in the Department of Family Medicine and Community Health at the University of Minnesota. Lori Glover, MHA, MS, ATC, is rehabilitation director at the Institute for Athletic Medicine, a service of Fairview and North Memorial.
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CARDIOLOGY
Heart failure
A look at common symptoms and treatments By Mosi Bennett, MD, PhD, and Terri Arndt, RN, MA, CCRC
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early 6 million Americans live each day with heart failure, a common condition in which the heart fails to pump enough blood to meet the body’s needs. By 2030, the American Heart Association estimates that number will reach 8 million, in part because of a growing percentage of older Americans.
The heart is a pump Heart muscle is essentially a pump made up of four interconnecting chambers. With each heartbeat, the four chambers relax and fill with blood, or they contract and pump blood in and out of each chamber to the lungs and throughout the body.
Aging, high blood pressure, diabetes, coronary artery disease, heart attack, valve disease, and other factors can cause heart failure, which can occur on either the left side (left ventricle) or the right side (right ventricle) of the heart. Most often it involves both sides.
The right side of the heart receives oxygen-poor blood from the body through the veins. The left side of the heart receives oxygen-rich blood from the lungs. The two top chambers are called the atria, and the two bottom chambers are called the ventricles. The heart pumps oxygen-poor blood from the right atria to the right ventricle of the heart and then on to the lungs, where it picks up oxygen. The oxygen-rich blood then returns to the left atria and on to the left ventricle, where it is pumped out to the body. The left ventricle of the heart is the largest of the four chambers and is considered the main pumping chamber.
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Many patients live meaningful lives by being aware of heart failure symptoms. Ejection fraction (EF) measures the percentage of blood that is pumped by the left ventricle. A healthy heart has an EF of 50–70 percent. In heart failure, the EF is usually reduced to 40 percent or below. However, heart failure can also occur with a normal EF.
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MINNESOTA HEALTH CARE NEWS AUGUST 2016
Types of heart failure Left ventricular heart failure occurs when the left ventricle has to work harder to pump the same volume of blood. Systolic heart failure, also called reduced EF, is one type of left ventricle heart failure in which the left ventricle does not contract (squeeze) hard enough to pump oxygen-rich blood out to the body. The EF is usually below 40 percent. Another type of left ventricle heart failure is diastolic heart failure, also called preserved ejection fraction, in which the left ventricle is able to contract normally and maintain normal EF. However, the ventricle becomes stiff and can’t fill adequately with oxygen-rich blood, resulting in less blood being pumped with each normal contraction.
Left ventricular heart failure frequently leads to right ventricular heart failure. Over time, as the left ventricle becomes a weakened pump, the blood moving from the lungs to the heart starts to back up in the lungs, causing the right side of the heart to weaken. Blood ultimately starts backing up (congestion) in the veins, which can lead to swelling (edema) in the ankles, legs, abdomen, and/or lungs.
Developing and maintaining a heart-healthy lifestyle is essential in treating heart failure. For example, eating heart-healthy foods such as fruits, vegetables, whole grains, fish, and healthy fats (monounsaturated and polyunsaturated) such as those found in nuts and seeds, olive and canola oils, salmon, and tofu, will help maintain a healthy weight. Get in the habit of reading food labels for serving size and sodium (salt) content. Limit salt intake to 1,500 to 2,000 milligrams (mg) of sodium each day. Limiting daily fluid intake is often necessary to control the symptoms of heart failure
A heart-healthy lifestyle is essential in treating heart failure.
Common symptoms of heart failure include shortness of breath, both while active and at rest; swelling (edema) in the feet, ankles, legs, or abdomen, along with weight gain; chronic cough or wheezing; feelings of fatigue or tiredness; and dizziness, lightheadedness, and an inability to concentrate. These signs and symptoms may be gradual or may come on suddenly. When symptoms are ignored, it can often lead to a hospital admission. The Centers for Disease Control and Prevention reports that congestive heart failure is one of the most common reasons for hospitalization among those ages 65 and older. If your symptoms change or if you develop new symptoms, see a heart failure cardiologist. Diagnosis Physicians will start with a physical exam, listening to the heart and lungs, checking blood pressure, and asking questions about any symptoms. To assist in the diagnosis and treatment plan, they may then order further tests, including:
With a physician’s approval, include a regular exercise program most days of the week. Check with your local hospital or community center for a phase IV cardiac rehabilitation program. These programs emphasize long-term lifestyle changes and help individuals practice and maintain healthy behaviors and habits. Program staff will monitor progress, provide heart-healthy lifestyle coaching, and communicate with your heart failure physician. Physicians also use a variety of prescription medications to treat and manage heart failure symptoms. It is very important to take these medications as prescribed. Heart failure to page 17
Electrocardiogram (EKG), which records the electrical activity of the heart and traces the heart rhythm. Chest X-ray of the heart, lungs, and chest cavity. Laboratory (blood) test to evaluate the presence of cardiac biomarkers that are released into the blood when the heart is damaged or stressed. Echocardiogram, which uses ultrasound to capture an image of the heart and determine how well the heart pumps and the valves move. Cardiac MRI, which uses large magnets and radio frequency waves to make pictures of the inside of the heart. Coronary angiogram, a procedure that allows the physician to see if the blood vessels in the heart are open, narrowed, or blocked. Treatment Lifestyle changes, medications, and more aggressive steps help many patients suffering from heart failure, as part of a treatment plan intended to: 1. Identify and treat the main cause of heart failure, such as coronary artery disease, high blood pressure, or valve disease. 2. Decrease the symptoms of heart failure. 3. Prevent the worsening of heart failure. 4. Improve quality of life.
Rogers Now Open in Minneapolis Rogers Behavioral Health is making mental health treatment more accessible with the opening of our Eden Prairie location. Offering specialized outpatient treatment five days a week, six hours a day, for kids and adults with OCD and anxiety, and adults with depression and other mood disorders. Call 844-599-8959 to make a referral. 6442 City West Parkway, Suite 200, Eden Prairie, MN 55344 | rogersbh.org
AUGUST 2016 MINNESOTA HEALTH CARE NEWS
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CALENDAR AUGUST-SEPTEMBER 2016 AUG. 19
Parkinson’s Disease Support Group
Allina Health offers this free monthly support group for people affected by Parkinson’s disease to learn more about available resources and share questions, concerns, and feelings about the disease. Call Sue or Nancy at (651) 653-1045 to sign up or for more information. Friday, Aug. 19, 1–2 p.m., HealthPartners Clinic, 2500 Como Ave., St. Paul
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Honoring Choices
Fairview Health Services hosts this free class for anyone over the age of 18. Trained facilitators will help attendees develop an advance care plan and a health care directive to have in place in the event of a sudden illness or injury in which you cannot communicate your care choices. No registration required; other dates are available. For more information, call (612) 672-7272. Wednesday, Aug. 24, 1–2:30 p.m., Fairview Clinics–Hiawatha, 3809 42nd Ave. S, Minneapolis
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Depression & Bipolar Disorder Support Group
Depression & Bipolar Support Alliance offers this twice-monthly support group for individuals living with depression or bipolar disorder. Come meet others living with similar conditions to gain understanding and coping strategies. For more information, call Bobby at (952) 938-8941. Thursday, Aug. 25, 7–9 p.m., Park Nicollet Melrose Center, 3525 Monterey Dr., St. Louis Park
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Breath and Stretch Techniques
Hennepin County Library presents this free class to learn breath and stretch techniques with certified yoga instructors from Big River Yoga. Come learn how to use the techniques for relaxation and better health. Call (612) 543-5669 to sign up or for more information.
National Breastfeeding Month During the month of August, the U.S. Breastfeeding Committee works to spread awareness of the benefits of breastfeeding and advocate for support for the women who choose to do so. Choosing to breastfeed can help protect babies from infections and illnesses, reduce the risks of sudden infant death syndrome, and protect against obesity in children who are breastfed for at least six months. Mothers themselves also benefit when they breastfeed, with decreased risks of breast and ovarian cancers. The act of breastfeeding has also been shown to help build a strong emotional bond between the mother and infant. In 1950, fewer than 20 percent of mothers started out breastfeeding their babies. That figure has jumped to 79 percent in 2014, according to a report from the Centers for Disease Control and Prevention. However, only 13 percent of babies are exclusively breastfed at six months old. Many mothers who start out breastfeeding report that they stop after the first few weeks or months due to having to return to work where they are separated from their babies and may lack the time and/or space to express milk. USBC advocates for employers to provide workplace lactation support for new mothers, noting that those who do experience lower health care costs, absenteeism, and turnover rates, as well as improved morale, job satisfaction, and productivity.
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Sunday, Aug. 28, 1–2 p.m., East Lake Library, 2727 E. Lake St., Minneapolis
Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/ Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Email submissions to amarlow@mppub.com or fax them to (612) 7288601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.
Baby Weigh-In
AMMA Parenting Center offers this free weekly meeting for new mothers and their babies to use the scale, track baby’s growth, and get guidance from lactation consultants who will be on hand to answer your feeding questions. Come meet other moms, share advice, and engage in discussions based on attendee questions. All mothers are welcome and all feeding decisions are supported. No registration required. Call (952) 926-2229 for more information. Tuesday, Aug. 23, 1–2 p.m., AMMA Parenting Center, 3511 Hazelton Rd., Edina
SEPT. 1
Lung Cancer Support Group
Minnesota Oncology offers this free monthly support group for patients with lung cancer and their family members and caregivers. Come gain social and emotional support, get advice from medical experts, and have your questions answered. No registration required. Call (612) 884-6300 for more information. Thursday, Sept. 1, 5:30–7 p.m., Minnesota Oncology, Conference Room, 910 E 26th St., Ste. 100, Minneapolis
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Car Seat Clinic
HealthPartners offers this free child and booster seat safety clinic. Certified car seat technicians from Regions Hospital 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. Monday, Sept. 12, 4–7 p.m., Regions Hospital, South Ramp, 640 Jackson St., St. Paul
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Family and Friends Eating Disorders Group
The Emily Program offers this support group for those with a loved one affected by an eating disorder. Come learn how an eating disorder can affect a person’s life and relationships, as well as how to best support them through their recovery. No registration required. Call (888) 364-5977 for more information. Monday, Sept. 12, 6–7:30 p.m., The Emily Program, 2265 Como Ave., St. Paul
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Lymphedema Class
Park Nicollet offers this free class for people who are at risk of developing lymphedema from surgical procedures or radiation therapy. Come learn the causes, signs, and symptoms of lymphedema and discuss practices to decrease the risk of developing it. Call (952) 993-5700 to register. Wednesday, Sept. 14, 12:30–1:30 p.m., Park Nicollet Frauenshuh Cancer Center, Curtis and Arlene Carlson Family Community Room, 3931 Louisiana Ave. S., St. Louis Park
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MINNESOTA HEALTH CARE NEWS AUGUST 2016
Quality of life Living with heart failure can be overwhelming. However, many patients live meaningful lives by being aware of heart failure symptoms, working closely with their heart failure team, maintaining heart-healthy lifestyle habits, and complying with medications. Talk to your physician about local resources and heart failure support groups. There are many beneficial resources available online to learn more about managing heart failure and living a hearthealthy life.
Heart failure from page 15
Common heart failure medications can help to: • Lower blood pressure and reduce strain on the heart (angiotensin-converting enzyme or ACE inhibitors). • Remove excess sodium through urine (aldosterone antagonists). • Relax blood vessels and lower blood pressure (angiotensin receptor blockers). • Slow heart rate and lower blood pressure (beta blockers).
Here are some excellent places to start:
• Make the heart beat stronger and pump more blood (digoxin).
• The DASH Diet Eating Plan: http://dashdiet.org
• Decrease excess fluid in the lungs and swelling in feet and ankles (diuretics).
• Medline Plus: www.nlm.nih.gov/medlineplus/heartfailure.html
• Relax blood vessels and reduce strain on the heart (vasodilators).
• National Heart, Lung, and Blood Institute: www.nhlbi.nih.gov/health/health-topics/topics/hf
• Improve shortness of breath and fatigue (oxygen therapy). When heart failure symptoms become severe and are no longer manageable through a healthy lifestyle and medication, there are other options to consider, such as:
• American Heart Association: www.heart.org/HEARTORG/Conditions/HeartFailure/ Heart-Failure_UCM_002019_SubHomePage.jsp • Heart Failure Society of America: www.hfsa.org
• Pacemakers or implantable cardioverter defibrillators (ICD) to manage irregular heart rhythms. • Left ventricular assist devices (LVAD) or mechanical heart pumps to help the heart pump. • Heart transplants to replace a sick heart with a healthy heart. • Research studies like stem cell therapies that are not yet available/approved by the Food and Drug Administration (FDA).
Mosi Bennett, MD, PhD, is a researcher and advanced heart failure and transplant cardiologist with the Minneapolis Heart Institute at Abbott Northwestern Hospital. Terri Arndt, RN, MA, CCRC, is clinical research manager at the Minneapolis Heart Institute Foundation, focusing in the areas of heart failure, stem cells, and acute coronary syndrome.
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MINNESOTA HEALTH CARE ROUNDTABLE
Mr. Starnes: Today we will discuss an important element in the evolution of health care delivery — innovation — how it is paid for and how it becomes assimilated into day-today medical practice. All too often, despite the best training, brightest minds, and highest intentions, short-sighted economic policies can delay adopting innovation and limit quality of life, in a way that other industries do not face. While these problems are hardly new, they demand our attention now because of the escalating pace of innovation. Significant advances in patient care are occurring almost too fast to track, and the health care delivery system must find better ways of utilizing them. Let’s start with a baseline question: what do we mean by medical innovation? Dr. Abbasi: I see medical innovation as being able or willing to look at a problem differently and to come up with solutions that go beyond what we are used to. An example is Dr. [Barry] Marshall, who went through a significant personal hardship to prove that a stomach ulcer is truly a bacterial infection that can be treated with a very short course of antibiotics. Up until then, it was treated with horrendous surgery, with high complication rates. He ingested [Helicobacter pylori] bacteria himself to prove that. Another example of looking outside the box may be the approach that [Takeru] Kobayashi takes in hot dog eating contests. I’m not advocating for that, but until then, everybody saw the problem as, “How can I eat so many hot dogs in a certain period of time?” He looked at it as, “How can I eat one hot dog as fast as I can?” By looking at it that way, he suddenly cut the times and records by one-third. All of a sudden this was a solvable problem, and now everybody could do it that way. Dr. Lumi: Innovation in medicine could best be defined as finding a way to treat a problem in a manner that is different from the standard of care. That might be a new discovery, a new technique, a new medication, or it may be a return to previous ways of doing things that just aren’t standard now. Innovation covers a broad spectrum, from technology to implementation. Dr. Beecher: One innovation would be covering people for risk, conditions, and circumstances that they can’t afford to
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Medical Innovation vs. Medical Economics When payment policies limit quality of life
ABOUT THE ROUNDTABLE Minnesota Physician Publishing’s forty- fifth Minnesota Health Care Roundtable examined the topic of “Medical innovation vs. medical economics: When payment policies limit quality of life.” Six panelists and our moderator met on April 21, 2016, to discuss this topic. The next roundtable, on November 3, 2016, will address Value-Based Reimbursement: A new way to pay for health care.
treat. Under the ACA [Affordable Care Act], we have seen a policy push towards government third-party payment and expansions of insurance. But innovation can also come at a cost, and we may see unintended consequences. So I’m looking for a patient-centered approach. A clinical example of that, for me, would be comparing addiction treatment over the last 50 years, when we didn’t have any form of organized treatments, to the current industry of addiction treatments. The Hazelden Betty Ford approach can be very effective, but it now has been grafted onto a managed care structure. What I’m curious about and following closely is individualized addiction treatment, which is an innovation in both the payment and the treatment arenas.
MINNESOTA HEALTH CARE NEWS AUGUST 2016
Mr. Starnes: That brings up an interesting point: can medical innovation include business models? Ms. McClernon: As a health care administrator, I’ve seen technology adopted by different disciplines. I’ve seen where it works and I’ve seen the need for a more organized approach to technology assessment. One example would be our quality committees. At one time, medical staff ran the medical committee, and I ran the hospital quality committee, which was looking at infection control, pharmacy, and other areas. We created one single quality committee. Initially that was not seen as the right thing to do, but that changed. For example, we once had an issue in cardiac where we had a high bleed rate. Our pharmacy people went back and worked together. Six months later, we realized that there was an issue between the protocols. Those two clinicians, working together, got everything corrected. I see that as innovation at a system level and an operations level. Dr. English: I think all of us view innovation as a new drug or a new surgical procedure or a new surgical machine, but my essential mantra is that cost is the issue that drives all the others. The area that I’m really interested in now is called direct pay to primary care physicians. It’s a membership model whereby for $75 a month, about what you pay for your cell phone bill, you have access to a network of primary care physicians, and you can see the doctor as often as you want. In theory, there are no bills to an insurance company. There is no coding. Whatever medical record you want to keep, you may keep. There are no mandates for electronic medical records. It is a contract strictly between the physician and the patient. If at any time the patient wants to leave, they leave. They don’t pay the bill the next month. Granted, you still need catastrophic insurance, but that is now a federal mandate under the ACA. So if you need specialty care, or if you need major medical illness care, your insurance will kick in. The philosophy is that primary care is or at least should be something that everybody uses at least once a year. It is an expected cost, just like your dentist. Medicine used to be like this. This is basically taking you back to a time when the
MINNESOTA HEALTH CARE ROUNDTABLE contract was between the doctor and the patient. This is actually innovation in the financing of medicine, but that is critically important, in my opinion. Ms. Larson: As others point out, innovation is just a new way of thinking about an existing problem. We know that the current health care system is not sustainable in the way that we have financed it and funded it to date. So I see innovation as looking at different models to pay for health care — for example, the Accountable Care Organizations [ACOs] through Medicare and the integrated health partnerships, which are essentially a Medicaid ACO. Under some types of payment models, you are starting to have a more collaborative relationship with the health plans, something that hasn’t happened in the past. Mr. Starnes: How do payment policies either slow the adoption of innovation or limit the quality of life? Dr. Lumi: For people with severe life-threatening obesity, bariatric surgery can improve quality of life and increase longevity; reduce risks of cancer, degenerative disease, and the number of medications used; and cut overall health care costs by three years after surgery. However, the average person only spends 2.5 years with any particular insurance company. The companies recognize this, and have pooled together to create barriers against bariatric surgery. In my mind, this is really quite unethical. If you had coronary artery disease and needed a four-vessel bypass and your insurance company said, “I’m sorry, you have to prove to us you can keep your LDL cholesterol under 150 for six months,” or, “You have to prove that you can remain nonsmoking for six months before we’ll authorize an operation that will improve your quality of life and longevity,” you would not stand for it. You would be up in arms, screaming, but that is what morbidly obese people face. Their insurance mandates that they must do this for six months, must do that for one year, and now there is a mandate amongst all insurance companies that they have to lose 10 percent of their body weight and keep it off for 12 full months before they will authorize bariatric surgery. Dr. Beecher: When I was a medical director in a large PPO [Preferred Provider Organization], I was on the pharmacy and therapeutics committee. Like most of the major payers
in Minnesota, we hired a pharmacy benefit management company [PBM] to try to balance the costs and benefits of specific medications. Many times there was some reference to peer-reviewed research, but in most cases it was a matter of holding onto something old that seemed to work just as effectively as something new unless it could be proven otherwise, because the new medications were usually patented and more expensive. There was a real pressure to ration care for the more expensive patented medications. That still happens. You might have an innovation for hepatitis C, perhaps, a new drug that is incredibly effective but costs an extraordinary amount. How would a committee balance those things? In our organization we relied a lot on the PBM, relied on the Express Scripts, or on other contractors to give us advice. They in turn would talk about what other companies were doing, so there is a consensual process that goes on within that rationing process in the insurance companies. Dr. English: Your plan undoubtedly has a formulary, and usually the company will say, “Well, this is based on best practices or expert opinion,” but the point is that formularies are different from one company to another, which doesn’t make any sense. Either there is one formulary, there is one best way to do things, or there isn’t one best way to do things. That’s not termed “kick-backs,” but “rebates.” Health insurance companies get tremendous amounts of money back that they don’t tell you about. They just say that the pharmacy cost was X. They don’t say that the pharmacy cost was X but that they got Y back. There is no parity in the selection of drugs. If there were, we would all have the same formulary. Ms. Larson: One of the initiatives we are working on now is an integrated behavioral health model. Within our Medicaid population, the most prevalent disease state is depression. So we are trying to integrate a behavioral health specialist within primary care. Studies show that, especially in Northern Minnesota, there is a shortage of behavioral health providers, there is a shortage of hospital space for these people, and they are ending up in the emergency rooms or in jail. We’re trying to reach these patients earlier by having the behavioral health specialist embedded in primary care clinics. This new model does not currently exist in the health care payment structures. We
Hamid R. Abbasi, MD, PhD, FACS, FAANS, is a board-certified neurosurgeon with the Tristate Brain and Spine Institute, with locations in Edina, Alexandria, and Crookston. Dr. Abbasi has extensive experience in minimally invasive spine surgery, including minimally invasive correction of deformities and scoliosis, and is among the small number of surgeons who have performed the highest number of minimally invasive OLLIF (Oblique Lateral Lumbar Interbody Fusion) procedures. Other practice areas include surgical pain management, complex spine surgery, trauma and spinal stabilizations, spine and spinal cord tumors, brain tumors, pituitary tumors, brain hemorrhage and non-emergent trauma vagal nerve stimulator, peripheral nerve, and carpal tunnel. Lee Beecher, MD, DLFAPA, FASAM, is president of the Minnesota Physician-Patient Alliance (MPPA), a nonprofit organization committed to improving health care. He is a distinguished life fellow of the American Psychiatric Association, a fellow of the American Society of Addiction Medicine, an adjunct professor of psychiatry at the University of Minnesota, and a member of the editorial board of Clinical Psychiatry News. Now retired, Dr. Beecher maintained a solo practice in adult and addiction psychiatry in St. Louis Park for more than four decades. E. John English, MD, is currently affiliated with PrimaCare Direct, a cooperative of Minnesota clinics offering unlimited primary care access for a low monthly fee of $75. A family practice physician, Dr. English retired from the Apple Valley Medical Clinic in 2008, which he founded in 1978 with four other physicians. Board-certified by the American Board of Family Practice, he also served as medical director and chairman of the board of Minnesota Healthcare Network, a group of independent practicing primary care physicians. Melissa Larson, MBA, is vice president of operations for Integrity Health Network, LLC, and Integrity Health Innovations, a Medicare-approved ACO. Her responsibilities include health plan contracting, reimbursement analysis, and working closely with member clinics to develop operational and collaborative strategies for successful emerging payment models. Ms. Larson has more than 20 years’ experience in health care, including 10 years in clinic administration. Crystal Lumi, MD, FACS, is in independent medical practice as Crystal Lumi, MD, PLC. Board-certified in surgery, she graduated from the University of Minnesota Medical School; served a residency in surgery at Marshfield Clinic/St. Joseph’s Hospital in Marshfield, Wis.; and served as a fellow in bariatric, metabolic, and minimally invasive surgery at the University of Minnesota Medical School. Susan McClernon, PhD, MA, is faculty director for the Health Services Management and Applied Business programs at the University of Minnesota. She recently led the development of a new Bachelors of Applied Science in Health Services Management at the University of Minnesota Twin Cities campus, a degree program that now has over 70 students in its first year. She is also the president and CEO of Innovative Healthcare Leadership, LLC, a health care consulting firm, which has been serving health care organizations since 2007. She is an active Fellow in the American College of Healthcare Executives and was named Hospital Administrator of the Year in 2007 by Minnesota Hospital Association’s HealthCare Auxiliary.
ABOUT THE MODERATOR Mike Starnes has been the publisher at Minnesota Physician Publishing since 1986. His duties include the production of MedFax, Minnesota Physician, Employee Benefits Planner, and Minnesota Health Care News; directing the Minnesota Health Care Consumer Association; and hosting the Minnesota Health Care Roundtable.
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MINNESOTA HEALTH CARE ROUNDTABLE “ I’m still waiting for a taker to help me educate the new generation of surgeons.” Hamid R. Abbasi, MD, PhD, FACS, FAANS Mr. Starnes: In other words, they would rather pay more for something that works less well. Dr. Abbasi: This is the reality. I’m being cynical now, but insurance companies know that if they delay, pretty soon it will become a different insurance company’s problem. Sometimes we have to circle back a year later with a different insurance company and so, if we are cynical about it, the method pays off. It pays to unload the problem to a different insurance carrier.
are fortunate enough to have some grant funding to try new things and to develop a working model, but at this time we only have a limited source of funding. Mr. Starnes: Let’s go back to hard scientific procedures. Hamid, you were involved with the OLLIF [Oblique Lateral Lumbar Interbody Fusion] surgical procedure for spinal fusion. It seems to have great outcomes, but how do the payers handle access to this procedure? Dr. Abbasi: I’m reminded of what Crystal said. She talked about a bariatric procedure that works, but the payers say, “We want those people to be motivated, so they should lose 10 percent of their weight first.” On paper, that sounds realistic, but when you dig deep down, you see that there are shortterm financial reasons that have very little to do with patient care. The first spinal surgery I was involved with took nine hours, and when I was in residency, we still spent seven hours. With OLLIF, we do it now in 35 minutes. The patient walks out of the hospital or surgical center two hours after the surgery. This is not about the surgical skills of one surgeon or the selection of a certain patient; it’s about a new procedure. This is the Kobayashi of hot dog eating. We published our data, and we have scientific proof that it costs less, cuts the surgery time to less than half, cuts the blood loss to one-tenth, and usually patients walk out of the surgery center on the same day. This data is available to insurance companies, but many of them deny the procedure, sometimes saying, “It’s not on our list.”
Dr. Lumi: Exactly. As we said before, the insurance company that is supposed to pay for it doesn’t want to pay for it. If they can find ways to delay paying for it or make it somebody else’s problem, that’s to their long-term benefit. Mr. Starnes: Payment policies cause many perverse incentives and have a ripple effect. If we solved the payment issue, then you would still have malpractice concerns or first-to-fail concerns. Even if a procedure like OLLIF is proven best, how am I going to do the number of procedures required to get good at it, and how is that going to happen? How does that slow the adoption of innovation? Dr. Abbasi: You practically named the problem. It is not good enough for one surgeon being able to do that, and it is not about one single center’s result. You need to show that you can repeat the same result somewhere else, and that is where we as a community need to come together. It takes 40 procedures to get efficient at OLLIF. I call them 40 cases of hell, because, as a private surgeon who doesn’t have a huge institution behind me, I’m responsible for every single one of those patients. If we decide as a society or as a medical community that this is truly good for our patients, we have to coach surgeons in the procedure, teach them, mentor them. That is what I do with our Inspired Spine initiative. I know that if I just go on a weekend course to teach somebody a new method, they will not become proficient, so we bring them to us. We ask them to gather their cases and prepare them with an experienced surgeon to coach them through that new procedure. Many of these procedures are so new that
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you cannot learn them in any university or residency program. As a matter of fact, I’m the only surgeon in the upper Midwest performing the OLLIF procedure and even though I have offered to teach residents in the local community, I’m still waiting for a taker to help me educate the new generation of surgeons. Ms. McClernon: We are caught between two systems when we innovate. We are trying to use scientific processes and to gather evidence showing the efficacy and the value of the product. At the same time, things are innovating so quickly. Oncology might be one model. Collaboratives have worked together to collect data, moving it from a university-only system out into community-based systems. They do this by partnering, by gathering data more quickly across a broad spectrum. The adoption of innovation moves more quickly as a result. Mr. Starnes: Does anyone have insight into the role the FDA [Food and Drug Administration] plays in hampering or otherwise slowing innovation? Ms. McClernon: I was involved with the new Watchman device, which is placed in a part of the heart to reduce the risk of stroke. I happened to have a personal family member get involved in the trial phase, and it worked beautifully. My brother, who is a training and development person working with the company, was trying to get FDA approval, but they were running into complications. So he got some of the top cardiologists that were performing this procedure together, and they went through the process. They identified the key steps, and from that they rebuilt the training. They reduced complications to the point where they finally got FDA approval. Dr. Abbasi: We need to put a structure in place that encourages people to go out, bring their methods out, and let their success become a community success. I can tell you from personal experience how painful that process is, how slow that process is. It is a double-edged sword. Dr. Beecher: Another dimension that concerns me a great deal as a psychiatrist is the question of what we call things. In behavioral health, we talk about a DSM-V, this tremendously expanded lexicon of different states of normal and beyond, and we correlate things using statistical analysis. Under the Affordable Care Act, we have so-called mental health parity, which tries
MINNESOTA HEALTH CARE ROUNDTABLE to ensure that mental health patients and chemically dependent people have access to care. But we talk about behavioral health and mental health as if we know what those are. Not only do we say that we know what they are, but we talk about how we are going to pay for them and how we are going to capitate for them and how 80 percent of our pharmacology is coming through primary care for major mental illness. We have a crisis in our state hospital system right now. We have segregated mentally ill people from the rest. We have been doing that for ages, ever since I was a young doctor. But this idea of somehow correlating diagnosis with treatment is a tricky business. Mr. Starnes: When organizations focus on innovation, do they forget that the doctor/patient relationship is really the most important part of health care? Dr. Beecher: We are shifting our older notions of a doctor/patient relationship to an organization/consumer or an organization/enrollee relationship. That is not a pernicious thing necessarily, but how can an intelligent patient or consumer access information to make a sound decision? If you do, how are you going to pay for it, and what kind of vehicles do you have in the insurance market that allow a selection of different alternatives? The government has decided that we are going to guarantee that everyone can be issued insurance, without assessing individual risk. Now UnitedHealthcare is saying, “Hey, we don’t want to play that game anymore in the insurance exchanges, we are not making any money, so we are going to withdraw.” Organizations are going to make decisions based on their own self-interest, and it will lead to political discussions about what type of health care system we want to have. Bernie Sanders says that we have a right to health care, we are going to have Medicare for all, yet our Medicare system is in terrible shape. We haven’t figured out how to allocate resources. If we do not have competition among not only the insurance companies, but also the providers of care, how is the consumer going to make rational decisions? Our deductibles are also increasing, so now, unless you are on Medicare, you have a $5,000 deductible to deal with. Ms. McClernon: The issue of deductibles and copayments initially seems devastating. The good news is that it makes the consumer/patient get in the game. You look at it and say, “Hey, I have a decision on where
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the first $5,000 of my health care goes.” I’ve been making different decisions myself, and I’m seeing others make different decisions. I think that could be a positive way of getting us back into a part of the financing of our own health care. If it gets us to start taking responsibility, individually and for our families, I think that is a positive in the system. But it does cause hardship and leads some people to avoid seeing the doctor. Dr. English: I would agree, but somewhere between the $5,000 and, say, $25,000, if you plugged in the old-time indemnity insurance model, you could actually get people incentivized. The way it works now, when somebody gets sick with a major illness, they know they are going to blow through that $5,000. All bets are off after that. There is no incentive for them to be involved in the delivery of a $100,000 procedure that could come down in cost, but the patient, to really be involved, has to be involved incrementally. Granted, you are not trying to blow somebody out of the water, so there has to be a stop loss. I don’t know what level to pick for that to where you are no longer responsible, but I would add one caveat: that 80/20 indemnity, that works. Mr. Starnes: How can patients contribute to the adoption of medical innovation?
Dr. Beecher: My take on that is that the driving force for medical cannabis in Minnesota has nothing to do with pain relief. It really has to do with the fact that a lot of people in this state believe that marijuana should be legalized, that it should be available as it is in Oregon and in other states. This was a compromise position and it is unique. In no other state has anybody ever set up a system in which a physician is supposed to make a diagnosis and a pharmacist is supposed to decide the dosage for a drug that hasn’t been approved for anything that anybody is claiming it is for and then the commissioner of health is now empowered to say that it is okay for pain. This is really a political maneuver. Mr. Starnes: Sounds like some bad innovation. What about the idea of patient satisfaction? Melissa, we are so worried about whether patients are satisfied. Does this throw a monkey wrench into innovating? Ms. Larson: I believe so. We all know that it is important to engage patients and make sure that they are satisfied. But say you have brilliant surgeons with terrible bedside manners — how would the patient rate their value? What is it that the patient is valuing? Do they want a good outcome from their surgery or do they just want to feel good when they are speaking with the surgeon? That is a case where patient satisfaction can sometimes get in the way of good medical results.
Dr. English: The best example of where patients can be effective is medical marijuana. There is not a lot of science on this, this hasn’t been studied, this isn’t evidence-based medicine. Some people Dr. Lumi: When we talk about medical had anecdotal stories, and there is nothing innovation, there is often the “wow” factor. wrong with that, but the medical system is “Oh, I had my based on the scientific method, and it can gallbladder take years to figure out whether something taken out works. Anecdotal medicine is the exact opposite. It is one person saying, “I took this juniper berry juice for two weeks and I’ll tell you that “ Cost is the issue it works.” With medical that drives all marijuana, some patients got together, I’m sure they the others.” used the Internet as a platE. John English, MD form, and then they went up to the Legislature, and it passed. So the patients have input? Absolutely. I would hate to be sitting on an FDA panel. They are going to get nothing but pressure, and it will increase exponentially with the new drugs coming out.
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MINNESOTA HEALTH CARE ROUNDTABLE robotically.” It doesn’t matter to them that it cost twice as much, that they have bigger incisions than they would have had with traditional laparoscopy, that they have higher complication rates and the hospital is eating the bill because the payment for a standard laparoscopic gallbladder removal and a robotic gallbladder removal is the same even though the cost may be tripled. But patients say, “Oh, I had it done robotically.” It’s the shiny factor. You have to take a little step back and realize that patients aren’t always engaged in their health, and may have a variety of motives for what they choose. I always get a little irritated about the term “health care,” because most patients are not interested in caring for their health. They are interested in caring for their illness. They want illness care. They don’t want to see a doctor, they don’t want to be involved in eating right or exercising or doing anything else that might promote their health, they just don’t want to have a cold when they visit Aunt Sue down in Florida, because that would be inconvenient. Mr. Starnes: What can patients do to speed the development and adoption of medical innovation? Ms. McClernon: Health care has its own language, with its own ABCs and terms. Research shows that the more literate patients are about health and health care systems, the better their outcomes. We need to remind ourselves that we created this huge language and complex system, and ask ourselves how we can unwind that. We have to listen to our patients and get them involved in that process. This emphasis on patient satisfaction, where Medicare payments to health systems are based in part on patient experiences, is a crude way to get to it, but it has our attention now, economically, which is what we probably needed. We also need to remind patients how much their own behavior can impact their health.
people know words, it doesn’t mean they truly know what they mean or what their impact is. Assessing health literacy takes a lot of time, and time is one of the things that we don’t have in abundance in the examination room. If we are going to look at the economics of paying physicians for performance, and part of your performance is tied to your patient’s satisfaction, and patient satisfaction is based on them understanding what you have said, then you have a real problem. Ms. Larson: I believe that clinics, physicians, and providers need to look at what they communicate to patients and make sure that what they say is meaningful. Under the “meaningful use” mandates, we are required to provide a post-visit summary. Our EHRs [electronic health records] spit out a bunch of information, but is it truly useful? Does it tell the patient anything? When I visited my doctor, my post-visit summary told me what I came in for and what drugs I was on, but it didn’t tell me anything in between. We need to make sure that we communicate what we need to communicate, and we need to communicate in a manner that is good for our patients. Dr. Abbasi: It is not always easy to combine our many decades of experience and schooling in a 15-minute or a half-hour conversation, but I see that as our failure as providers or doctors. I have a hobby — quantum physics — and nobody could ever explain quantum physics the way I understand it. When I asked about it, they would say,
“ There is a difference between ‘health’ and ‘health care.’” L ee Beecher, MD, DLFAPA, FASAM
Dr. Lumi: Assessing health literacy is very difficult. Working in oncology and in bariatric surgery, there is a pantheon of words that the everyday layman may understand, but if I ask a patient, “What is a protein?” half the time I get a blank look. They can’t really define what a protein is. A famous senator, when asked how he would define pornography, once said, “Well, I can’t define it but I know it when I see it.” Many of my patients would say, “Well, I would know what a protein was if I saw it.” Health literacy is kind of a sticky wicket. Just because
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“Because we don’t understand it either.” Sometimes doctors have trouble communicating information. I have a busy practice, and sometimes I’m late and sometimes my patients are angry because they had to wait an hour to see me, but it is extremely rare that a patient leaves my examination room and is unhappy. I often hear them say, “Doctor, I’m so happy, this is the first time I really understood what is going on.” We need to give our patients a little more credit. We need to explain complex procedures in terms that they understand. For example, I always compare a disc to a tire of a car. Everybody understands what it means to have a flat tire. It would be futile if you tried to communicate with them as if they were doctors who had gone through med school, but if we put it in other terms, we can communicate the essence. If we cannot do that, then we have a problem in our education system. Mr. Starnes: In terms of involving the patients in speeding the adoption of innovation, how could social media be applied? I mean, how can we get those cell phones to help this? Dr. Abbasi: Technology has made information available to everybody. Remember those big encyclopedias that you had to buy? You’d spend something like $10,000 and have 40 volumes in your library, paying them off every month over 10 years. Now all of us have a smart phone. Not everything on the Internet is correct, but whose fault is that? How much time did I take out of my busy clinical life to put expert information out there, so that my patient does not have to rely on some shady person from somewhere else? I’m saying that because I was doing exactly that last night until 1:30
MINNESOTA HEALTH CARE ROUNDTABLE in the morning. I was putting information about minimally invasive spinal fusion surgery on my social media. This is exactly what it takes, and it is not easy. You have to stay awake until 1:30 in the morning, get the information, put it out, but you will find in the long run that it helps you. You can send a patient to your web page to see your post and to listen to a patient who has gone through the same surgery. We have to put information out there ourselves. If not us, who else? Dr. Beecher: I’m sure that Facebook and some of the newer media are being used, but there are some real privacy issues. How do you maintain boundaries when you have all of this information out there? If we want to involve patients in adopting innovation, we need to admit the complexity of the system, admit that we are just as befuddled by it. We are all working on that, but it is a partnership issue with the patient. It’s also a partnership among ourselves. If we delegate to a social worker or to an expert on the economy or insurance or whatever, it is not enough for that individual just to put it into the EHR and walk away. There has to be some sense from the patient that this answers their questions and it is an ongoing relationship. When in doubt, we need to refer to the patient’s needs and complaints. Many times we get off on our own tangent or something and it is not just because they haven’t gone to medical school and don’t understand what a protein is. It is because we are not relating this to their particular needs, that’s the key to it. Mr. Starnes: Are there other ways in which social media could drive the adoption of innovation? Ms. McClernon: We have FitBit devices and health apps on our phones that track our steps and calories. I often think if we just bought that $100 FitBit for each of our patients, we probably would gain a lot. Mr. Starnes: What role can direct-toconsumer advertising play in adopting medical innovation? Dr. Beecher: I’m fundamentally a capitalist at heart and I believe in the free market, but holy cow, you watch television and see the commercials for Viagra and Eliquis — my goodness, you almost get nauseated, and you might develop the side effects that they are telling you about just from watching the commercial. Obviously, these things are being supported by
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Pharma, who has “ The insurance company been kicked out of that is supposed to the doctor’s office pay for it doesn’t as primary care want to pay for it.” doctors have given up their practices Crystal Lumi, MD, FACS and gone into big systems. The reps used to bring their computers in to show us their studies, but all of that stuff is now going directly to the consumer because they have to go through the [pharmacy and therapeutic] committees and the [pharmacy benefit managers] and through the other organizational steps to get the drugs approved. So I’m of two minds. The patients should have choice, but I don’t think they are getting choice through this direct-to-consumer advertising, which of my teachers knew it. This rep came to must be costing a lot. I’m not sure what the me, educated me. I’m not using all the techalternative is. niques they showed me, I put that through Dr. English: The alternative is more direct-to-consumer advertising. I think it is a great thing. I think it is a horrible thing when the health care systems cut out drug salesmen. It is actually a perversion. The assumption here, apparently, is that the health care systems know what’s best for patients more than the drug people do, especially in primary care. Primary care covers everything, so as a doctor, you should have some vague knowledge of what each medication does, even if you’re not prescribing it. I really looked forward to visits from drug salesmen when they used to come in. If you got to know them, they would say, “I just want to tell you that some doctors are using this medication for this condition. You should know about it, too.” That is invaluable. If you are actually a practicing physician, actually seeing people, that’s your livelihood, you need these tips. You can’t go through journals. That’s a full-time job, paging through journals or studies. So the answer, as far as I’m concerned, is more direct-to-consumer advertising. No filters. Dr. Abbasi: I’m totally with John on that. There is a huge value in the free market society. Obviously we have to learn as well in med school to be critical. You shouldn’t take everything they say as truth and you have to digest it through your own intellectual capacity, but I can tell you from my residency that I learned many things from that new method that was developed. None
my own intellectual and training and inquisitive mind, but I cannot overemphasize how important that was for me. Ms. McClernon: I was in the administrative wings when we moved the pharmaceutical companies out. It was very difficult for them to be in between physicians, and yet we lost a lot when we kicked them out, because they were often giving us samples for patients who didn’t have funding, and we were learning techniques. I think it challenged our own pharmacy people to have to work together. I think the easy answer, often times, is just to mandate it out. The pharmaceutical companies, we know, are very innovative, and that is why we have direct advertising. Essentially that was their end around, to say, “Well then fine, we’ll just go direct to the patient.” All of you clinicians, I’m sure, hear things like, “This should take care of my restless leg syndrome, right?” Dr. Lumi: The advantage of direct consumer marketing is that it develops patient awareness that they may have a medical condition that should be treated. They may have something else — they may actually have a gastric cancer instead of gastric reflux — but it brings them into the office, and gives us an opportunity to intervene in helping to diagnose and treat them. The downside is trying to talk them out of the particular medication that they are certain is going to cure the symptom or the problem
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MINNESOTA HEALTH CARE ROUNDTABLE “ Keep making the system simpler instead of more complex.”
outsourced crowd-managed publication. As long as your paper is within the scientific methods, your paper will get published and the crowd, the people, the folks Susan McClernon, out there, they decide how PhD, MA much impact your paper has, utilizing the wisdom of the crowd. It reminds me of a very old story from the 1800s. [Sir Francis Galton] goes to a market and there is a game in which random people guess the weight of a cow, and whoever is closest gets the cow. They were all wrong, but after the process was over, he averaged their guesses, and that turned out to be within pounds of the actual weight. I think our peer review needs crowd sourcing.
that they may or may not have. That is often very thorny because they will get mad and choose to go to someone else who is happy to sit and think about their golf game for five minutes, let the patient talk, write them a prescription, walk them out the door, and then charge for a level-III visit. So I see it as a double-edged sword. I think that anything that you can do to stimulate patient education, patient engagement, is an innovation in health care. However, we have to make sure that the other side of the sword isn’t sharper. Mr. Starnes: What can be done to improve the peer review process of medical literature that could expedite the adoption of innovation? Dr. Abbasi: We are scientists, but we have the same biases and fallacies of every person. I may believe that my research is more important than your research, or that my opinion is more valuable than your opinion. The traditional peer review process is a long, extensive process. Your paper gets sent to somebody else, and if the topic of his research doesn’t match the topic of your research, all of a sudden questions come back that you believe are not relevant to what you are trying to say. Those who have tried to publish a peer-reviewed paper will know that. Dr. [John] Adler, a neurosurgeon at Stanford, started a website [www.cureus.com] that has essentially
Dr. Lumi: If you choose to crowd source peer review and just let all comers criticize your paper, thumbs up/thumbs down, is there going to be a corresponding medical innovation where that idea, that process, that new thing that you are touting, gets carried forth into actual practice? The academic societies or big Pharma or anything else, are not going to accept a crowd-sourced peer review article. They are going to want standardized, peer-reviewed articles. My question is, can crowd sourcing translate into actual medical innovation that is disseminated? Dr. Abbasi: That is a good question. If I start evaluating a physics article, my opinion shouldn’t be equal to somebody who has done 30 years of physics, but my opinion shouldn’t be completely dismissed either. We need to be smart about that. Using the example about guessing the weight of a cow, individuals may be wrong, but the wisdom of the crowd is always more than the sum of individual contributors. Mr. Starnes: Let’s move on and talk about innovation in medical education. Are there some things that have been implemented recently or are there some things that should be implemented? Ms. McClernon: The cross disciplines in education are starting to work together. We are breaking down silos to capitalize on our strengths and produce better outcomes. Most of the clinical people I meet say that understanding more about the industry and the business side of health care would help them. I spent most of my career educating clinicians so that they
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could speak the language to get the capital and the staff they needed to move forward, and I see that as the role of health care administrators. If we can start that type of thinking earlier in the educational process, we can encourage innovation. For example, in some patient safety studies, multidisciplinary teams from different universities compete with each other on the types of challenges they might face in the health system. They have turned it into an interesting educational process. Mr. Starnes: Anybody else with innovations in medical education? Dr. Lumi: One of the more recent failures in innovation in medical education is the whole issue of certification maintenance within certain specialties. It started as a good idea. Once you became board-certified in a specialty, at intervals you needed to complete certain tasks to demonstrate proficiency until you took your next certification exam. What it evolved into is an extremely expensive, onerous, time-consuming, and worthless process for most physicians, one that has recently been rescinded by the American Board of Medical Specialties. It is a real challenge, in the rapid pace of change within clinical medicine, to remain current in your own specialty, let alone if you are a primary care provider who has to know a little bit about everything. I think that rescinding it was probably the wrong thing to do, but it needs an overhaul. For clinicians to just keep their heads above water, we need periodic checks and balances, because we are human and we are lazy and we would rather sleep in on Sunday mornings than read a medical journal for two hours. I see it as one step forward and two steps back in the whole maintenance of certification. Mr. Starnes: Are there examples of innovation in medicine that have not been slowed by payment policies? Dr. Lumi: When laparoscopic gallbladder removal—cholecystectomy—came out in the late 1980s, there was an overnight surge in people lining up to get their gallbladders out through four small incisions rather than the traditional 6–8-inch incision, week in the hospital, and six-week recovery period. Patient demand drove the implementation of laparoscopic cholecystectomy ahead of the data and the coding standards. There were some complications back then, but many believed that
MINNESOTA HEALTH CARE ROUNDTABLE laparoscopic cholecystectomy was equally safe and equally effective, and there was a huge demand for it. Insurance companies scrambled to keep up with this particular innovation. I trained during that period, and part of my residency training was learning to code and bill. We would charge for open cholecystectomy because there was no code for a laparoscopic cholecystectomy. Within a year, there was a code. A grass roots movement by patients pushed not only the coding system run by the Centers for Medicare Services, but it pushed medical innovation in terms of new instruments, new designs, new operating room designs, changes in how operating rooms were built, and it opened the door to a whole bunch of other innovations. People asked, “Well, if we can take the gallbladder out this way, could we do this and this and this?” That happened in the blink of an eye. Dr. English: There are a couple of examples that affected cardiothoracic surgeons. I once thought that with all of this coronary sponsored by artery disease and the entire population getting older, they could work from dawn until midnight, every day of the week. All of a sudden, overnight, stents came in. I don’t want to say that it decimated their profession, but actually it did. All these people had counted on this open-heart coronary artery bypass, and it went away. Another thing in place right now is femoral artery insertion of an aortic valve. What a deal. You don’t blink an eye. You can be 82, and you can have this valve inserted and walk out of there. Dr. Beecher: Outpatient electroconvulsive treatment is one example of innovation in psychiatric care delivery. It happened in the 60s and 70s, but really came into its own in the 1980s. For people with bipolar disorder, serious depression, even schizophrenia that is out of control and isn’t controlled with antipsychotics, this treatment helped. You could bring people in on an outpatient system involving multidisciplinary care, do a very thorough exam, get the families involved, provide the treatment, and allow people to go home. I did that for many, many years, and I can’t tell you the number of suicidal people that we brought around. They didn’t have to be institutionalized, and we saved thousands if not millions of dollars. There are innovative hospital and clinic systems like Abbott Northwestern, the old Metropolitan Medical Center, and others that have very
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good ECT clinics. This is something that isn’t written up very often, but it is a combination of a treatment that works, that is stigmatized in many ways and not well thought of by many people, even by some in the mental health community, but it really works and if it is done systematically and when needed on a long-term basis it can save lives and save money. Mr. Starnes: What are the most important things that need to be done to change the way payment policies limit quality of life? Ms. Larson: In a perfect world, I would say that we take the power to make decisions out of the insurance company’s hands and give it back to medicine. I think that physicians should be in the driver’s seat for these things and ideally that is what will drive the change. Dr. English: I would say patient empowerment. Physicians shouldn’t necessarily be in the driver’s seat. The patient actually should be in the driver’s seat. We have to meet their expectations. The flip side of that is patient responsibility. Somehow that has to be woven together before we are going to get an answer. Dr. Lumi: My fairy tale world is universal access, where access to medical care is not denied because of age, income, or any other barrier, and that everybody has the opportunity to get not just illness care, but true health care and wellness care.
have to go beyond short-term thinking and focus on long-term, evidence-based health care, not just illness-based systems. I’m also still befuddled by the ACA. Before it passed, we had a Medicaid system, and we had a Medicare system. We could have just taken people who were uninsured and put them into those two systems, instead of creating this complex world of exchanges. We have wasted at least five years chasing the wrong rabbit, I would say. I would like to keep making the system simpler instead of more complex. I’m concerned about corporate medicine. If we lose the incentive of our individual physicians and clinicians to influence care, we will lose out on innovation. Dr. Beecher: There is a difference between “health” and “health care.” That line gets blurred, even in primary care. We need to learn about nutrition, about alcoholism, about smoking, about public health issues and so many other things, but that is not necessarily the health care system’s job. All citizens need to realize we are all paying for this, and we all need to get educated. If we can empower the patients, the reform will have to come through our insurance reform. The ACA went way too far. It actually tried to set up a stakeholder system with everybody around the table, and the insurance companies are now beginning to bail. It is going to be really interesting to see how this plays out.
Dr. Abbasi: We don’t want the government to interfere too much in our patient/doctor relationship. In reality, insurance companies do that every day. I think we all want to be in an environment that considers all aspects, including cost, but I do believe that the intrusion of the insurance companies in the patient/doctor relationship has been “ Patient satisfaction more extensive than can sometimes get what government in the way of good could ever do, and I medical results.” think it needs to be limited.
Melissa Larson, MBA
Ms. McClernon: We need access, but we can have all the access in the world and still not have enough providers, especially in primary care. Patient responsibility and engagement are vital, but we have to help patients navigate a complex health system. We
Minnesota Physician-Patient Alliance AUGUST 2016 MINNESOTA HEALTH CARE NEWS
25
REHABILITATION
Physical therapy
Participate in your own recovery By Jennifer Missling, MS, PT, ATC
P
eople suffering pain and impaired mobility due to injury or chronic conditions know all too well the heavy toll these can take on daily functions and quality of life. Physical therapists (PTs) provide relief on both fronts, working with patients on everything from trauma to the brain or spinal cord, personal injuries stemming from accidents or overuse, chronic low back pain, and more. The end result of physical therapy could be fewer headaches and less pain at work and home, increased independence in daily life, or regaining the ability to walk after a tragic car accident. As with any other treatment, however, the right plan is critical, and patients who participate at every stage have the best prospects.
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It isn’t always easy—one of my first patients told me that PT stands for “Pain and Torture”—but it does not have to be an unpleasant experience. The key is to begin with realistic expectations, ask the right questions, and participate at each stage.
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The resulting treatment plans typically include active exercise to improve range of motion, strength, and endurance. PTs may also use hands-on techniques or manual therapies to help stretch joints and muscles, decrease or increase nervous system responses, or reduce inflammation. Much of the therapy is intended to teach patients how to improve or manage the condition on their own through exercise, self-treatments, or adaptations in their home or workplace. A comprehensive treatment plan often involves both periodic office visits and at-home exercises and activities.
Changes in function, strength, and endurance take time.
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What is physical therapy? PTs evaluate multiple factors contributing to pain and loss of function, and develop individualized treatment plans intended to alleviate these contributors or impairments. Evaluations often target active range of motion and mobility of the joints, muscle strength, physical endurance, posture habits, muscle tenderness and inflammation, joint mechanics, and post-injury impairments. PTs also observe movements, gait (walking quality), balance, and coordination. For certain types of injury, they may perform other tests and measurements of the nervous and muscular systems.
MINNESOTA HEALTH CARE NEWS AUGUST 2016
Achieving the best outcomes Growing evidence demonstrates that patient engagement—from following through on recommendations to maintaining confidence—contributes to optimal physical therapy outcomes. The best-laid plans simply will not work unless there is a strong partnership between the patient and the therapist. Here are a few things to consider when participating in physical therapy: Participate in goal setting. Patients who are involved in their own goal setting are shown to have better outcomes. Make your goals functional and “SMART”: Specific, Measurable, Attainable, Realistic, and Time-based. Think about something you can’t do right now, that you want to be able to do. For example, if you avoid playing with your
toddler because your back aches when you sit on the floor, a SMART goal might be: To play on the floor with my kids for 20 minutes with minimal discomfort. Aim for success you can build upon. It may not be realistic, for example, to expect to play for hours without any pain. Expect slow and steady progress. Changes in function, strength, and endurance take time. It’s not uncommon to suffer setbacks as you start to push yourself to do more activities. Be patient and kind to yourself. Small gains are still progress, and staying focused and committed to your goals will get you there.
conversations with your PT regarding your plan and how to make it work for you. Create a partnership. For best outcomes, the physical therapist and patient must partner together. When the patient believes it is the therapist’s sole responsibility to “fix their pain or problem” and they are merely a passive participant, the physical therapy will fail. Likewise, if the PT fails to listen and develop a treatment plan that works for both parties, it will fail. Open communication and active listening with shared treatment planning always works best.
Recovering from an injury or accident can be a lot of work.
Think positively. How you think about your outcome plays a large role in successful therapy. We have a strong mind-body connection, especially when it comes to pain and symptoms, motivation, and focus. If you don’t believe you will get better, you won’t. Ask your therapist about self-meditation, breathing, and positive thinking strategies, or seek these out on your own. Your brain has the power to modulate pain, heal, and create different neurochemicals that directly impact how you feel and how you function. Learn to be your own physical therapist. Following exercise prescriptions or recommendations is one thing, but learning how to modify and progress is much more effective. Patients need to learn what to do if the exercise becomes too easy, and must learn when and how to progress in difficulty. How often do you need to do the exercises? At what point do you discontinue the therapeutic exercise and move into a maintenance routine? Do you need to do this on an ongoing basis, or only until you reach a certain level? A good therapist will teach you about exercise progression and aftercare maintenance and prevention. Ask yourself if you are ready to make behavioral changes. Chronic injuries such as low back pain often spring from behavioral factors. Lack of exercise, stress, poor nutrition, poor ergonomics, and poor activity pacing are all behaviors that skyrocket inflammation and cortisol, both of which contribute to pain. Pain is your body’s way of saying “stop!” These habits contribute to the pain response, and if you aren’t ready to change such behaviors, your therapy will not be successful. Recognize barriers to behavioral change. We all go through similar stages when considering behavioral changes. As we contemplate change, we recognize that it is something we should do, even if it’s on the back burner. We often become ambivalent, weighing pros and cons before moving on to planning and action. Once we start, we must commit to a plan to continue new habits or behaviors, since it’s easy to fall into relapse. Develop action and relapse plans. Talk to your therapist about where you are at with behavioral change, and develop ideas on how to fit the new exercises or behaviors into your daily routine. Consider creating a schedule for yourself, and commit to it. Have honest
A journey to better health Recovering from an injury or accident can be a lot of work, and it usually isn’t an easy road. However, seeking an effective physical therapy partner and developing a plan can be a great experience. You may not only improve your daily function and reach your goals, you may learn a lot about yourself. Often when we overcome great challenges in life—including those we felt we didn’t deserve or ask for— we become most proud of ourselves or learn something more about who we are. If it wasn’t for your injury, you wouldn’t have taken this path, and perhaps it’s a new path to insight and better health. Jennifer Missling, MS, PT, ATC, is rehabilitation director at Physicians’ Diagnostics & Rehabilitation Clinics, a multi-disciplinary practice that uses a biopsychosocial approach to non-surgically address neck and low back pain. A certified athletic trainer, she focuses on the treatment of chronic neck and low back pain.
Telephone Equipment Distribution (TED) Program
Use a journal and checklist. Journaling is therapeutic for many reasons. Noting accomplishments or “checking off” something creates a chemical “feel good” response in the brain, helping you to stay motivated and positive. Also, writing down questions to ask your therapist can help you have more meaningful sessions. Track your improvements in function. Many times, patients can’t even remember how poorly they were functioning at the beginning of their therapy and are surprised when they look back at their journals or their treatment notes to see how far they have come.
Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.
1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services AUGUST 2016 MINNESOTA HEALTH CARE NEWS
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EMERGENCY MEDICINE
Trauma centers
Saving lives when seconds count By Jonathan C. Gipson, MD, FACS, and Melissa A.L. Thorson, MS, APRN, CCNS
W
e all hope never to need emergency care, but in extreme circumstances, specially equipped trauma centers could save lives. Typically located within emergency departments (EDs), designated trauma centers provide multi-specialist teams that are poised to handle severe medical emergencies, including life-threatening or critical injuries. Minnesota’s trauma system specifies criteria for transportation, designation of hospitals as trauma centers, and governance to ensure optimal care and outcomes.
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MINNESOTA HEALTH CARE NEWS AUGUST 2016
One scenario Most people associate trauma with gunshots or stabbings, but motor vehicle collisions, serious falls, and severe personal injuries can produce major crises requiring more than an ED; these cases need the coordinated specialist care available only at designated trauma centers. Picture this scenario: a young woman is involved in a motor vehicle crash and roll-over, throwing her out of the vehicle and onto the highway. The Emergency Medical System (EMS) is activated and the ambulance responds quickly. Paramedics insert a breathing tube, attach a back board and neck collar for safety during transport, and administer intravenous fluids and pain medications before the ambulance ride to a specially designed ED trauma stabilization room. Notified ahead of arrival, the trauma surgeon and the emergency medicine physician lead the resuscitation based on standardized, proven methods, coordinating the work of registered nurses, lab technologists, emergency room technicians, radiology technologists, residents, and medical students. This systematic approach allows all participants to quickly assess the patient and start life-saving interventions. Specialized trauma care continues with a Computed Tomography (CT) scan to determine the location and extent of injuries and to establish the surgical approach. The next stop is the trauma operating room, a specially designed facility that allows trauma surgeons and interventional radiologists to work collaboratively, utilizing equipment required by both specialties. Our patient has massive blood loss due to tears in her liver and spleen. Two trauma surgeons control the bleeding, while the interventional radiologist evaluates major blood vessels in real time to help direct the operation. After the procedure, the patient is taken to the trauma intensive care unit, where she receives 24-hour evaluation by trauma surgeons, critical care nurses, and respiratory therapists. She undergoes additional operations to ensure healing of her internal abdominal organs, surviving her injuries through the routine—but heroic—efforts of her trauma team. A broader spectrum of care This scenario involved an ambulance ride to a designated trauma center, but trauma care could also start with a visit to a local hospital, followed by transport to a trauma center by ground or by
air. In all trauma centers, board-certified specialty physicians and surgeons, along with highly trained emergency physicians, advanced practice providers, and nurses are on site or on-call around the clock for consultation and treatment. The trauma surgeon leads the team of specially trained professionals for patients who require hospitalization following emergency surgery or temporary admissions to intensive care units (ICUs) or acute care floors. Patients in the trauma ICU receive specialized care from critical care nurses and doctors. Each nurse in the trauma ICU is responsible for only one or two patients. Standards of care, based on trauma research, are individualized for various injury patterns. Additional specialists may also be brought in to assist with rehabilitation, including speech, occupational, and physical therapists. Social workers, child life specialists, and chaplains attend to psychosocial needs. Depending on the severity of injuries and the course of hospitalization, patients may be discharged to their homes to live independently or with supportive services, to transitional care, or to acute long- or short-term rehabilitation programs. After a follow-up visit to the trauma clinic, care is turned over to the patient’s primary provider. Recognition of trauma care as specialized care The Minnesota Department of Health (MDH) ranks trauma as the leading cause of death for residents ages 1–44 and the third leading cause of death for Minnesotans of all ages. More than 2,400 Minnesotans die from trauma each year. For every injury death, nine people are hospitalized for injuries, most of them involving falls and motor vehicle crashes.
Quality and performance improvement Trauma centers continually measure, evaluate, and strive to enhance their performance. Data from each verified/designated trauma center in Minnesota are submitted to the MDH Statewide Trauma System for State and Regional improvement. Level I and II trauma centers also submit data to the National Trauma Data Bank (NTDB) and the Trauma Quality Improvement Project. This data allows centers
Each nurse in the trauma ICU is responsible for only one or two patients. to use quality indicators to track and evaluate measures such as performance, patient safety, and patient outcomes. Performance Improvement (PI) is the hallmark of a mature trauma program. It serves to evaluate and improve the process of care, evaluate the outcome of care, reduce inappropriate variation in care, and identify opportunities for improvement. Outreach, education, and research According to the ACS-COT, a Level I trauma center is expected to Trauma centers to page 34
Trauma centers emerged from a realization that these traumatic injuries represent a disease process requiring specialized and experienced multidisciplinary treatment and specialized resources. The American College of Surgeons set the standards for excellence in trauma care, and continues to develop and implement meaningful trauma care programs in local, regional, national, and international arenas. In Minnesota, the MDH oversees the designation of hospitals as trauma facilities.
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Trauma centers are designated as Level I–V. The highest two levels, Level I and Level II, are verified as trauma centers by the American College of Surgeons Committee on Trauma (ACS-COT) and then further designated by the states. The Level I verification means that a facility has all of the resources to care for the most complicated and life-threatening injuries. In recent years, the ACS-COT started issuing separate verifications for adult and pediatric trauma care programs. Level I and Level II trauma centers are able to care definitively for major trauma such as: • Spinal cord injuries • Significant traumatic brain injuries • Major pelvic fractures • Major chest wall injuries • Multiple long bone fractures • Multiple system injuries
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TAKE CARE
Food poisoning A look at the common causes By Stephanie Meyer, MPH
S
ummertime through early fall is ideal for picnics and cookouts, but it’s also a peak time for foodborne diseases, which strike 1 in 6 Americans each year. Often referred to as food poisoning, these diseases may involve just one patient, or may be part of a broader community outbreak stemming from a single food source. Fortunately, with proper food preparation and a healthy respect for the risks, we can have our food and enjoy it too—without a trip to the doctor.
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Four types Foodborne illnesses result from four main types of germs: Toxins and chemicals. When foods are stored improperly, bacteria may multiply and produce toxins. Food may also be contaminated by contact with chemicals leached from metal containers or other sources. Severe bouts of vomiting and/or diarrhea often strike within hours. Viruses. Multiple viruses can produce short-term vomiting and diarrhea, typically within 12–48 hours. Bacterial infections. Several forms of bacteria cause illness within 1–7 days, lasting a week or more with bloody diarrhea, serious disease, and potential long-term aftereffects. Parasites. Cryptosporidium, Cyclospora, and other parasites found in food and water can produce watery diarrhea in about one week, with the potential for persistent and relapsing illness and weight loss. Four pathogens Norovirus is the most common foodborne pathogen, producing an average of 30 outbreaks each year in Minnesota. Norovirus causes vomiting and diarrhea, aches, and sometimes a low-grade fever lasting 1–2 days, with symptoms appearing 12–48 hours after exposure. If complaints matching this description are reported to the Minnesota Department of Health’s (MDH) foodborne illness hotline (1-877-FOOD-ILL), the department may investigate to identify potential community outbreaks. Most norovirus outbreaks involve contamination of foods by one or more ill or recently ill food workers who did not wash their hands adequately. State or local environmental health professionals visit outbreak establishments, interview foodservice staff, identify and exclude ill employees, and address sanitation and food handling. In nursing homes or schools where patients become ill after a common meal, MDH and environmental health professionals may intervene, perhaps eliminating self-service food lines, serving meals to residents in their rooms while they are ill, and canceling activities that involve sharing. Campylobacter bacteria produce 900–1,000 laboratory-confirmed infections in Minnesota annually; there may be 30 times that number of unconfirmed infections. Symptoms include diarrhea,
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MINNESOTA HEALTH CARE NEWS AUGUST 2016
abdominal pain, and fever, often within 2–5 days (range, 1–10 days) of exposure and lasting up to 1–2 weeks. Approximately 15 percent of patients with confirmed infections are hospitalized. Health care professionals must report Campylobacter infections to the MDH. Campylobacter can increase risk of Guillain-Barré syndrome, reactive arthritis, and irritable bowel syndrome. Antibiotics can shorten the duration, but treatment usually is not required. Campylobacter is a common source of “traveler’s diarrhea,” but only 20 percent of foreign travelers have infections that can be treated with ciprofloxacin, the common antibiotic for these types of infection.
severe or even life-threatening, particularly those that result in hemolytic uremic syndrome (HUS), which involves kidney failure and can be fatal. This is why identification of STEC outbreaks is vital. MDH investigated 50 E. coli O157 outbreaks during 1996–2015, including nine community outbreaks due to ground beef that resulted in seven recalls. Together with other states, MDH documented for the first time that hazelnuts could transmit the bacteria, and investigated outbreaks related to produce, including celery and leafy greens. Contaminated flour was the likely source in one outbreak involving dessert pizza, adding to a growing concern about flour and other processed foods as the source of foodborne illness. Contact with calves and goats at public venues and private farms is another common source of STEC infections.
Foodborne diseases… strike 1 in 6 Americans each year.
Campylobacter infections often are acquired from undercooked poultry, unpasteurized milk, untreated water, farm animals—especially cattle and poultry—and foods contaminated with juices from raw chicken. Pets, particularly those with diarrhea, are also a source. Salmonella bacteria are the most frequent cause of bacterial foodborne outbreaks in Minnesota, typically producing 750–800 cases of salmonellosis annually (974 in 2015). Symptoms include diarrhea, cramps, and fever within 6 hours to 7 days or more (but most commonly within 1–4 days) after exposure and lasting 4–7 days. Approximately 27 percent are hospitalized; a small percentage experience invasive localized or bloodstream infections. Unless the patient is very young, immunocompromised, or severely ill, antibiotics are generally not recommended for uncomplicated Salmonella gastroenteritis. Most foods—including undercooked beef and poultry, unpasteurized milk, eggs, fresh produce, and processed foods—can carry Salmonella. Direct contact with animals, especially reptiles, baby chicks, and ducklings, is another extremely common source, along with contact with ill people or contaminated water.
Preventing transmission Because foodborne illness outbreaks are frequently linked to foodservice workers experiencing vomiting or diarrhea, employees with these symptoms must stay away from work until at least 24 hours after their symptoms resolve. More specific restrictions apply for certain pathogens and job duties. Food poisoning to page 32
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Salmonella infections must be reported to MDH. There are about 2,500 types of Salmonella that can cause human illness, so investigators focus on the type of bacteria to identify common sources of infection, intervene, and prevent additional transmission. In 2007, MDH epidemiologists identified pot pies as the cause of a national outbreak. More recently, Minnesota investigations were also key in solving recent national outbreaks associated with forms of Salmonella in hot peppers, peanut butter, blueberries, eggs, tahini, cucumbers, raw tuna, and tomatoes. E. coli O157 and other Shiga toxin-producing E. coli are bacteria found in the intestinal tract of humans and other animals. Most of the 700 serotypes of E. coli are harmless, but a few strains can cause severe abdominal cramps, bloody diarrhea, and vomiting. Shiga toxin-producing E. coli (STEC) cause these symptoms, with illness usually starting within 3–4 days (range, 1–8 days) of exposure and lasting 5–7 days. More than 30 percent of patients with confirmed infections are hospitalized. Illness often involves watery diarrhea that turns bloody after a day or two, as well as pronounced abdominal cramps. About half experience low-grade fever, which usually is not present by the time patients seek health care. This picture helps distinguish STEC infections from Salmonella, Campylobacter, and Shigella infections, which frequently cause more pronounced fevers. While some STEC infections are mild, others are
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Food poisoning from page 31
Children attending childcare facilities or preschools often spread intestinal infections from multiple pathogens, some of which pose severe disease risk for those under 5. Children with E. coli O157 and
The great outdoors As we approach Labor Day and cookouts, remember to: • Use coolers to protect raw meats, poultry, seafood, salads, and other perishables. • Use separate cutting boards, coolers, and utensils for raw meats and ready-to-eat items.
Severe bouts of vomiting and/or diarrhea often strike within hours. certain other types of STEC infections must stay home until they test negative in two consecutive tests performed at least 24 hours apart. Childcare facilities also see person-to-person transmission of Shigella bacteria, which is only found in humans. Children with Shigella should stay home until 48 hours after diarrhea has stopped, they have tested negative for the pathogen, or they have taken antibiotics for 24 hours and been free of diarrhea for 24 hours. For all other pathogens, it is important for children to stay home until 24 hours after their recovery from vomiting and diarrhea. Most viral, bacterial, and parasitic foodborne pathogens can also be transmitted person-to-person through the fecal-oral route. Handwashing plays a key role in preventing illness, as does staying home while actively ill with symptoms of diarrhea or vomiting. Some infections can also be spread during certain types of sexual activity, including oral-anal contact or oral contact with contaminated skin.
• Use food thermometers when cooking and grilling to make sure meats reach the proper temperature (visit www.health.state. mn.us/foodsafety/cook/grill.html for temperature guidelines). • Use clean plates and tongs, and never reuse tongs that touch raw meats until they have been cleaned thoroughly. • Wash hands when preparing foods, and don’t prepare food for others if you’ve had vomiting or diarrhea recently. The Great Minnesota Get-Together At MDH, state fair time means inspecting restaurant stands and food service facilities, working with vendors to ensure food safety, and being on-site to keep food safe. MDH licenses 250 food stands at the state fair, conducts 300 inspections, and has 20 inspectors who circulate before the fair and during its first few days. We also keep two inspectors on-site throughout the fair to help with new issues—and to ensure that we enjoy new and interesting foods as we bring a safe and healthy end to the summer. Stephanie Meyer, MPH, is an epidemiologist with the Minnesota Department of Health’s Foodborne, Waterborne, Vectorborne, and Zoonotic Diseases Section.
M I N N E S OTA H E A LT H C A R E
July 2016 Survey
CO N S U M E R A S S O C I AT I O N
Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. I am familiar with my options should I or a member of my family require residential long-term care.
2. I and/or members of my family have a plan in place should we require long-term care. 80
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0 Strongly agree
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4. I believe I have adequate financial resources to afford long-term care. 40
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No opinion
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5. I believe that safety net access to high quality long-term care should be addressed through legislation. 50
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MINNESOTA HEALTH CARE NEWS AUGUST 2016
3. I am aware that there are a wide range of long-term care services that would allow me or a member of my family to continue living at home.
Strongly agree
Agree
No opinion
Disagree
Strongly disagree
Strongly agree
Agree
No opinion
For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.
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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.
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Trauma centers from page 29
be a leader in trauma care in its community, conducting trauma research and providing education, prevention, and outreach activities. Sample activities include bike helmet fittings, car seat checks, life jacket loaner programs, and violence prevention programs. Educational programs include prevention-based lectures or courses in advanced trauma life support (ATLS) for emergency care providers. Finally, involvement in direct research, as well as dissemination of findings, is critical to the improvement of trauma care.
triage, and transport guidelines consistent with criteria issued by the State Trauma Advisory Council (STAC) and approved by the Emergency Medical Services Regulatory Board (EMSRB). Legislation also requires that patients who have sustained major trauma are transported to the highest level of trauma care available within 30 minutes.
More than 2,400 Minnesotans die from trauma each year.
The Minnesota statewide trauma system The 60 minutes between sustaining a severe injury and receiving definitive care—a period commonly referred to as the “golden hour” by the medical community—is the most important predictor of survival. Trauma systems enhance the chance of survival during this time, regardless of proximity to an urban trauma center. Minnesota’s statewide trauma system provides an organized response to manage and improve care for the severely injured, and to ensure prompt transport and appropriate treatment at trauma hospitals. State legislation requires ambulance services licensed to participate in the statewide trauma system to have written, age-appropriate
Trauma care in Minnesota is also improved through the guidance of STAC and Regional Trauma Advisory Committees (RTACs), whose appointed members apply expertise and experience in EMS, prevention, and all levels of trauma center care.
When seconds count In the event of life-threatening crises, Minnesota’s designated trauma centers and statewide trauma system are poised to provide specialized critical care services on short notice, and to follow through from admission to recovery and reentry into the community. They can make the difference between life and death. Jonathan C. Gipson, MD, FACS, a fellow of the American College of Surgeons and a member of the Eastern Association for the Surgery of Trauma, is trauma medical director at North Memorial Medical Center. Melissa A.L. Thorson, MS, APRN, CCNS, a licensed advanced practice nurse certified in adult critical care, is director of critical care and trauma at North Memorial Medical Center.
Now accepting new patients
A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures. Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.
We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health. Whether you have experienced any type of cardiac event, are at risk for one, or
are interested in learning how to prevent one, we can design a set of just-for-you solutions. Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions
To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com
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MINNESOTA HEALTH CARE NEWS AUGUST 2016
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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].
VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1
for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013
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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8
mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® Placebo + Glimepiride Rosiglitazone + All Victoza + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® Placebo + Metformin + Rosiglitazone All Victoza + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested
®
Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits
Reductions up to -1.1%a
Weight loss up to 5.5 lba,b
Low rate of hypoglycemiac
1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a
b
A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.
The change begins at VictozaPro.com. Indications and Usage
Victoza (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin. ®
Important Safety Information
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%). Please see brief summary of Prescribing Information on adjacent page. 1013-00018617-1
December 2013