November 2015 • Volume 13 Number 11
Online mental health Richard F. Sethre, PsyD, and Deb Rich, PhD
Bronchitis Heather Hamernick, MD
Anemia Julie Anderson, MD
rehabilitate T oowith rehabilitate aa body, body, we we start start with the the mind mind and and soul. soul.
If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a If you or someone you know needs rehabilitation after an accident, surgery, illness or stroke, we have a simple premise for you to consider: To recover physically, you need support mentally and emotionally. How simple premise for you to consider: To recover physically, you need support mentally and emotionally. How positive and how determined someone is can make all the difference. We believe the most effective therapy positive and how determined someone is can make all the difference. We believe the most effective therapy treats your body, mind and soul. That’s our approach. treats your body, mind and soul. That’s our approach. Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. outpatient locations throughout Minnesota and the Minneapolis/St. Paul area. To make a referral or for more information, call us at To make a referral or for more information, call us at (888) GSS-CARE or visit www.good-sam.com/minnesota. (888) GSS-CARE or visit www.good-sam.com/minnesota.
The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, stateGood or local laws. Some services may housing be provided a thirdtoparty. All faiths or beliefs are welcome. 2015color, The Evangelical Lutheran Goodfamilial Samaritan Society. All rights 15-G1553statuses according The Evangelical Lutheran Samaritan Society provides and by services qualified individuals without regard to©race, religion, gender, disability, status, national origin reserved. or other protected to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. © 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G1553
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Minnesota Health care news November 2015
November 2015 • Volume 13 Number 11
4 7 8 10 12
News
PEOPLE
PERSPECTIVE Senator Christine Ann “Chris” Eaton
10 QUESTIONS Shelley R. Stanton, MD The Federal Medical Center, Rochester
Environmental Health The effects of air quality
By Monika Vadali, PhD
14 16
18 20 22
cALENDAR
Home Care
Life care managers By Angela Nelson, RN
26
FORTyFOURTH SESSION
B ehavioral Health
Online mental health services
By Richard F. Sethre, PsyD, LP, and Deb Rich, PhD, LP, CPLC
24
MINNESOTA HEALTH CARE ROUNDTABLE
H ematology Anemia
By Julie Anderson, MD, FAAFP, CIC
End-of-Life Issues
Advance care planning By Thaddeus Mason Pope, JD, PhD
Pulmonology Bronchitis
By Heather Hamernick, MD
Oncology
Skin cancer
By Kathryn Barlow, MD,
and Julie Cronk, MD
Behavioral Health Integration New pathways to care
Thursday, November 12, 2015 • 1:00-4:00 PM Downtown Minneapolis Hilton and Towers Background and Focus: Increasing evidence supports the link between access to mental health care and reducing health care costs. Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider. Many initiatives nationwide are addressing this issue. It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015. Some states, including Minnesota, are also creating Behavioral Health Home programs. Objectives: We will review numerous initiatives that support the development of new pathways to behavioral health care. We will introduce new ideas and discuss how to incorporate them into our health-care delivery system. We will examine the value they can bring and the challenges they will face. Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring. Panelists include: • Sarah Anderson, MSW, LICSW, CEO, Psych Recovery, Inc. • Lee Beecher, MD, President, Minnesota Physician-Patient Alliance • Timothy P. Gibbs, MD, FAPA, DFAACAP, Chief Medical Officer, Natalis Counseling and Psychology Solutions • Martha Lantz, MSW, LICSW, MBA, Executive Dir., Touchstone Mental Health • Judge Kerry W. Meyer, Hennepin County Criminal Mental Health Court • Jane C. Pederson, MD, MS, Chief Medical Quality Officer, Stratis Health • Jeff Schiff, MD, MBA, Medical Director, MN Dept. of Human Services • L. Read Sulik, MD, Chief Integration Officer, PrairieCare Sponsors include: • Janssen Pharmaceuticals, Inc. • MN Dept. of Human Services • Psych Recovery, Inc.
Publisher Mike Starnes | mstarnes@mppub.com Editor Lisa McGowan | lmcgowan@mppub.com Associate Editor Richard Ericson | rericson@mppub.com Art Director Joe Pfahl | joe@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com Account Executive Stacey Bush | sbush@mppub.com Account Executive Kylie Engle | kengle@mppub.com Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@mppub. com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.
• MN Community Healthcare Network • PrairieCare • Natalis Outcomes • Stratis Health
Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable. Name Company Address City, State, ZIP Telephone/FAX Card #
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Please mail, call in, or fax your registration by 11/5/2015. November 2015 Minnesota Health care news
3
News
Projects Funded to Help Aging Minnesotans Remain in Their Homes
that benefit both older Minnesotans and their caregivers.”
losing all PreferredOne health plans and more than 4,750 plans from Blue Cross and Blue Shield of Minnesota and HealthPartners in 2015.
According to DHS, many of the recipients are nonprofit and community organizations. All recipients will be required to Blue Cross and Blue Shield of The Minnesota Department of generate income by charging for Minnesota is removing policies Human Services has awarded services through a sliding fee scale. that cover about 6,500 people more than $7 million in Live Well from the exchange and offering The grants will help address at Home grants to 62 organithem directly to customers for the challenges of the state’s Aging zations for projects focusing on 2016. That accounts for about 2030 initiative, which addresses allowing older Minnesotans to 25 percent of current Blue Cross the challenges that come with the stay in their homes instead of rate of aging Minnesotans and the policy holders that purchase insurmoving to nursing homes or other preparations needed for the demo- ance through MNsure. Officials care settings. graphic changes. According to the say if all of those enrollees renew “Minnesota is a national leader website, baby boomers are turning their coverage outside of MNsure, in long-term services and supports 65 at the rate of 10,000 per day in it will cost the exchange between $800,000 and $1 million in revefor older adults in part because the U.S. nue next year because it will not we provide this seed money to be able to collect the 3.5 percent community organizations and fee on those plans. providers to be creative in helping people remain in their homes as Blue Cross and Blue Shield of they age,” said Lucinda Jesson, Minnesota maintains that they human services commissioner. are not removing policies to avoid “In addition to helping meet daily the MNsure fee. The companeeds such as nutrition and house- Health insurers in Minnesota ny says that it has consolidated keeping, these grants promote new are removing more options from several policies into one health MNsure for 2016 enrollment after technology and other innovations plan they say is more effective, but
Insurers Removing More Policies from MNsure
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Minnesota Health care news November 2015
because Minnesota laws will not allow them to eliminate old plans entirely, the product change moves customers away from the exchange in some cases. “The withhold from MNsure has little, if any, material impact on our product decisions,” said Blue Cross and Blue Shield of Minnesota spokesman Scott Keefer. Many of the policies it is removing from MNsure are platinum grade, and it is currently the only insurer that offers this level of policies on the exchange. Some gold, silver, and bronze policies are being removed as well, but new policies are being added. It will send notices out to its customers alerting them to rate increases and other changes, and informing them that their plan will no longer be offered through MNsure, giving them the choice between taking no action and keeping their current policy directly through the insurer, or choosing a new plan through MNsure.
There is concern that this trend will affect the future of MNsure because it relies on the 3.5 percent fee per policy to help fund its operation.
Specifically, there was a 22.4 percent drop in charity care, the component of uncompensated care in which hospitals provide care without expecting payment, a decline of $34.6 million. There was “It’s something I have my eye on,” said Alison O’Toole, MNsure a greater drop in charity care for uninsured patients (24.6 percent) CEO. “And it’s potentially an than there was for insured patients issue.” (17.8 percent). This was the second time since 2001 that charity care dropped in Minnesota.
New Crisis Resource Website Launched
The Minnesota Department of Human Services has announced the launch of a new version of the MinnesotaHelp.info website, which features a new Crisis Link page to connect people with resources for a variety of immediate crisis needs, including mental health problems, substance abuse problems, emergency housing needs, fear of being harmed, or health care, food, job, or transportation needs. Minnesota residents can find contact information for organizations that serve their specific needs and hotlines for suicide and domestic violence. In addition, the website has an online chat service available from 8 a.m. to 4:30 p.m. on weekdays. “We want to make sure that people know there is a single place, the Crisis Link, they can go to get information and phone numbers for helping professionals and agencies that meet a variety of immediate needs,” said Lucinda Jesson, DHS commissioner. The Crisis Link is part of the state’s information and assistance program that also includes Senior LinkAge Line, Disability LinkAge Line, and Veterans LinkAge Line, and is supported by several agencies in addition to DHS, including the Minnesota Board on Aging.
Charity Care Decreased at Minnesota Hospitals There was a 6.3 percent drop in uncompensated care at Minnesota hospitals from 2013 to 2014, the first year MNsure was implemented, according to the Minnesota Department of Health (MDH).
Freedom Medicare. Do more of what you love.
However, there was a 9.3 percent increase in bad debt, the component of uncompensated care in which hospitals expect payment but do not receive it. That number increased $14.9 million from 2013 to 2014, when it reached $174.2 million. MDH said that the amount of bad debt has been rising steadily in Minnesota and that the increase was due to patients taking on more of their rising health care costs through higher deductibles and copays. “We are pleased that more Minnesotans now have the benefits of health coverage when they go to a hospital,” said Ed Ehlinger, MD, Minnesota commissioner of health. “However, the rising cost of health care continues to pose a threat to access to care. Without addressing health care costs through additional reforms or prevention efforts, even those patients with insurance increasingly are struggling with medical bills and unpaid care or bad debt.”
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Ucare, Essentia Health Partner on Medicare Plan UCare and Essentia Health have formed a Preferred Provider Organization (PPO) Medicare Advantage Plan called EssentiaCare. To be eligible for EssentiaCare, Minnesota patients must qualify for Medicare and live in the 10-county service area, which includes Aitkin, Clay, Becker, Carlton, Cass, Crow Wing, Hubbard, Itasca, Lake, and St. Louis Counties. Patients will have two coverage options—Secure, which offers lower monthly premiums and higher costs for copays, and Grand, News to page 6
Our Medicare plans help you live an active life. You’re free to roam with our travel coverage. And you’ll likely be free to keep your doctor. Learn more at healthpartners.com/medicare.
H2462_92682 Accepted 10/14/2015 HealthPartners is a Cost plan with a Medicare contract. Enrollment in HealthPartners depends on contract renewal. ©2015 HealthPartners
INFORMATION
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Terry Thomas
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November 2015 Minnesota Health care news
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News from page 5
which offers higher premiums and lower out-of-pocket costs. Enrollees will have access to services at any of Essentia Health’s 68 clinics and 18 hospitals, or at out-of-network providers if they are willing to pay higher out-ofpocket costs. The plan also allows patients access to specialists at Mayo Clinic at in-network benefit levels for more complex conditions if their physician refers them. Patients can enroll in EssentiaCare during the fall open enrollment period for Medicare Advantage Plans, which takes place Oct. 15 through Dec. 7. Coverage will be effective Jan. 1. They are hosting informational meetings in October and November. The two organizations have a 50/50 partnership in the plan, meaning they will equally share in the plan’s operation, revenue, and expenses.
Tobacco Use Increases Risks for Peripheral Artery Disease A new study from the University of Minnesota Medical School’s Cardiovascular Division has shown that continued tobacco use has a devastating impact on the number of heart attacks, serious leg artery blockages, strokes, and aneurysms in people with peripheral artery disease (PAD). Researchers analyzed 2011 claims data from Blue Cross and Blue Shield of Minnesota for more than 22,000 PAD patients. “Everyone knows tobacco hurts health, but until now no one has known how amazingly powerful this impact is. For people with PAD, smoking is especially bad: The health impact is ‘right now’ and the cost to the patient, society, and health payers is gigantic,” said Sue Duval, PhD, lead author of the study and associate professor
of medicine and biostatistics in the Cardiovascular Division at the University of Minnesota Medical School. “This study represents one of the largest measurements of the impact of PAD on health, in our state, and the nation. Because Minnesota is a state that is known to be ‘heart healthy,’ the implications of this research, and the costs of smoking, are sure to be even higher around the country and world.”
smoked tobacco was $17,673 more in the first year than those who did not smoke.
“I have studied PAD for over two decades and these results startled me. It also stuns me that patients, families, health systems, and government do not seem shocked. Preventable suffering continues every year,” said Alan Hirsch, MD, senior author of the study and professor of medicine, epidemiology, and community Researchers also found that health in the Cardiovascular Diviover the one-year period, people sion at the University of Minnesowith PAD who smoked had treta Medical School. “Tobacco use mendous short-term health risks is to heart and vascular disease and that 49 percent of tobacco like gasoline thrown on a fire. users with PAD were hospitalized. We know that each full effort to That is 35 percent higher than the help a person quit smoking costs number of PAD patients who do less than $500. Compared to the not smoke tobacco. Those who nearly $18,000 per year in added smoked were also much more frehealth care costs, giving patients quently admitted to hospitals for every tool to quit is the greatest leg artery blockages, heart disease, health bargain around. We must stroke, pneumonia, and bronchitis. treat the causes of disease, and The data showed that in addinot just consequences. Our lives tion to increased health risks, the and pocket books depend on this average cost for each patient who radical change.”
WHEN IT COMES TO GIFTS FOR YOUR KIDS, LOTTERY TICKETS ARE A BAD BET.
MUST BE 18 OR OLDER TO PLAY
6
Minnesota Health care news November 2015
Jennifer Ballantine has been named executive director of Able Palms Home Health of Minneapolis, a Medicare certified home health agency managed by The Goodman Group. Ballantine will be based in Chaska at the company’s headquarters. Most recently, she served as the director of business development for Recover Health, a home health Jennifer agency where she previously held positions in marBallantine keting, Medicare compliance, training, and business development. Ballantine has a bachelor’s of science in business administration from Metropolitan State University. Richard Launer, MD, has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location. Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota, where he has also served as an assistant adjunct professor of ophthalmology. Before joining Minnesota Eye Consultants, Richard Launer, Launer practiced with Progressive Eye Care and MD ProEyeCare Associates. He emphasized using new technologies and techniques to improve cataract and refractive surgery. He was one of the first to perform topical, small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota. Ngozi Mbibi, RN, of The Mother Baby Center at Abbott Northwestern and Children’s–Minneapolis, has been inducted as a fellow into the American Academy of Nursing. She was one of 163 nurses in the U.S. to be selected in 2015. Mbibi earned her midwifery license in Nigeria in 1978, where she worked for 24 years before coming to the U.S. Here, she earned her master’s degree in nursing health care Ngozi Mbibi, RN leadership and nursing education from Bethel University and a doctor of nursing practice from the University of Minnesota. She serves as vice president of the National Association of Nigerian Nurses in North America, which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures. Caryn McGeary, RN, MHA, has been named director of patient care services at Affiliated Community Medical Centers (ACMC). McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska. She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qualCaryn McGeary, ity and patient safety coordinator. Prior to joining RN, MHA ACMC, McGeary held positions at Douglas County Hospital and Hennepin County Medical Center. In her new role, McGeary is responsible for planning, organizing, and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system.
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During this seminar you will: • Deepen your understanding of executive functioning. • Discover the optimal conditions for developing executive functioning. • Learn more about evidence-based interventions that promote self-regulatory skills in children.
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November 2015 Minnesota Health care news
7
P e r s p e ct i v e
The Compassionate Care Act Giving Minnesotans a choice
“W
Senator Christine Ann “Chris” Eaton Sen. Eaton (DFL) represents Minnesota Senate District 40, which includes Brooklyn Center and Brooklyn Park. She serves as the DFL majority whip and as vice chair for the State and Local Government Committee. Her special legislative concerns include health care, labor issues, social justice, and the environment. Sen. Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years.
ill you take me to Oregon?” This was Dave’s plea as he slowly died from endstage cancer. At age 95, Dave had lost his mobility, independence, and organ function, but his mind remained sharp. He didn’t want to die this way and his son could do little to help. Dave’s son is now supporting my bill, the Minnesota Compassionate Care Act, so that other Minnesotans in his father’s situation will have an option to end their suffering.
provided information about hospice, palliative medicine, and other treatment options. They are also given the opportunity to rescind their request at any time.
About the bill
Others who oppose the bill do so based on misinformation. They fear the law will be used against the disabled, minority groups, or the poor, or that insurance companies or the government will deny medical care to the terminally ill. Some argue that better hospice care will make this option unnecessary. A look at the Oregon Public Health Division’s 1998-2014 data dispels these myths. Of the patients who utilized DWDA:
Individuals should have the option.
The Compassionate Care Act, modeled after Oregon’s 1997 Death with Dignity Act (DWDA), allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose. To protect the vulnerable, only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying. There are no lethal injections and this is not “assisted suicide.”
As someone who has spent over 40 years working with people with mental illness—the last 19 as a registered nurse—I firmly oppose “assisting” patients in need of mental health services to end their lives. Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable.
• Most were white, over age 65, and with advanced education. • The two most common diagnoses were malignant cancer (78 percent) and amyotrophic lateral sclerosis, or ALS (8 percent). • The most common reasons given were loss of autonomy, reduced ability to engage in enjoyable activities, loss of dignity, and loss of control of bodily functions.
I encourage you to read more about these differences at www.itsnotassistedsuicide.org, or to visit www. thebrittanyfund.org. The latter site was launched to honor 29-year-old Brittany Maynard, who moved her family to Oregon as she faced stage-four brain cancer. Under that state’s law, she ended her life on her terms, after telling loved ones, “There is a difference between a person who is suicidal and a person who is dying. I do not want to die. I am dying.”
Finally, some fear the bill will begin a slippery slope leading to involuntary euthanasia. That fearful speculation has no basis in reality. In 17 years under Oregon’s DWDA, there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards.
Personal choices
A personal note
Patients, in consultation with their families and doctors, should have the freedom to decide what’s best. In a Gallup poll, 75 percent agreed that “doctors should be allowed by law to end the patient’s life by some painless means when the patient and his or her family request it.” Oregon, Washington, Vermont, and Montana now allow aid in dying, with legislation pending in 20 more states. Under my bill, a patient must be an adult Minnesota resident, terminally ill, and of sound mind. A request for aid in dying must be made in writing twice, at least 15 days apart, and signed in the presence of two witnesses. Two physicians must determine that the patient is terminally ill, competent, and free from coercion. Any doubt or disagreement between physicians requires a third evaluation. Patients are repeatedly
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Some will oppose the bill for religious reasons. To them, end-of-life suffering is God’s will and medical intervention is wrong. I understand and respect this view. Freedom of religion is a foundation of our democracy. No one will be required to participate in this law, whether patient, caretaker, or physician.
Minnesota Health care news November 2015
• Ninety percent were enrolled in hospice.
As a nurse, I’ve seen a great deal of human suffering. I have cared for people dying of many forms of cancer, ALS, and Huntington’s chorea. Many were content with the care they received from hospice and family. Those who lived beyond their tolerance of pain and loss of dignity, begged caregivers to help them die. Aid in dying should not be a crime. Individuals should have the option to determine how they live and die. I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life. Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at www.leg.state.mn.us/leg/trackbill.aspx. Contact your legislator at www.leg.state.mn.us/ leg/legdir.aspx. Unsure of your legislative district? Visit www.leg.state.mn.us/leg/districtfinder.aspx.
“I’ve “I’vetrusted trustedthe the health healthcare care providers providersat at Essentia EssentiaHealth Health for foryears. years.”” “That’s “That’s “That’swhy why whyI’m I’m I’mexcited excited excitedabout about about EssentiaCare.”* EssentiaCare.”* EssentiaCare.”* Introducing Introducing IntroducingEssentiaCare, EssentiaCare, EssentiaCare,aaanew new newMedicare Medicare Medicare plan plan planfrom from fromUCare UCare UCareand and andEssentia Essentia EssentiaHealth. Health. Health. EssentiaCare EssentiaCare EssentiaCarecombines combines combinesthe the thehealth health healthcare care careyou you you know know knowand and andtrust trust trustfrom from fromEssentia Essentia EssentiaHealth Health Healthwith with withsmart smart smart health health healthcoverage coverage coveragefrom from fromUCare. UCare. UCare.Benefits Benefits Benefitsinclude include include no no noor or orlow low lowcopays copays copaysfor for fordoctor doctor doctorvisits, visits, visits,prescription prescription prescription drug drug drugcoverage, coverage, coverage,dental dental dentalcoverage, coverage, coverage,travel travel travelcoverage, coverage, coverage, fitness fitness fitnessprograms programs programsand and andmore. more. more.IfIfIfyou’re you’re you’reeligible eligible eligible for for forMedicare—whether Medicare—whether Medicare—whetheror or ornot not notyou’re you’re you’reaaacurrent current current Essentia Essentia EssentiaHealth Health Healthpatient—find patient—find patient—findout out outabout about aboutan an an affordable affordable affordablenew new newchoice. choice. choice. Get Get Getplan plan plandetails details detailsnow now nowfor for forcoverage coverage coveragebeginning beginning beginning in ininJanuary January January2016 2016 2016at at atEssentiaCare.org, EssentiaCare.org, EssentiaCare.org,or or or call call call218-722-4783, 218-722-4783, 218-722-4783,1-855-432-7027 1-855-432-7027 1-855-432-7027toll toll tollfree, free, free, or or orTTY TTY TTY1-800-688-2534 1-800-688-2534 1-800-688-2534toll toll tollfree, free, free,888a.m. a.m. a.m.to to to 888p.m. p.m. p.m.daily. daily. daily. *Paid *Paid *PaidActor Actor ActorPortrayal Portrayal Portrayal
Limitations, Limitations, Limitations,copayments, copayments, copayments,and and andrestrictions restrictions restrictions may may mayapply. apply. apply.This This Thisinformation information informationisisisnot not notaaa complete complete completedescription description descriptionof of ofbenefits. benefits. benefits.Contact Contact Contact the the theplan plan planfor for formore more moreinformation. information. information.Benefits Benefits Benefits“““ and/or and/or and/orcopayments copayments copaymentsmay may maychange change changeon on on January January January111of of ofeach each eachyear. year. year.EssentiaCare EssentiaCare EssentiaCareisisis aaaPPO PPO PPOplan plan planwith with withaaaMedicare Medicare Medicarecontract. contract. contract. Enrollment Enrollment Enrollmentin ininEssentiaCare EssentiaCare EssentiaCaredepends depends dependson on on contract contract contractrenewal. renewal. renewal. © ©©2015, 2015, 2015,UCare UCare UCare H0735_091515_2 H0735_091515_2 H0735_091515_2CMS CMS CMSAccepted Accepted Accepted (09202015) (09202015) (09202015) November 2015 Minnesota Health care news
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10 Questions
A healing presence Shelley R. Stanton, MD
The Federal Medical Center, Rochester Dr. Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses. Dr. Stanton has also worked in community mental health, as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin. She has spent the last nine years working at FMC Rochester, first as the clinical director overseeing the medical care at the institution, and for the last six and a half years as the chief psychiatrist. Please tell us about the Federal Medical Center, Rochester. The Federal Medical Center, Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP), and has a medical and a mental health mission. We are accredited by the Joint Commission and held to the same standards as any community health care institution. FMC Rochester currently houses about 784 male inmates. About half of those inmates are here for medical or psychiatric care, while the other half are healthy individuals, most of whom are from the Midwest. We have multiple medical missions, including infectious disease, wound care, rehabilitation/physical therapy, and long-term care. Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses. We currently have 135 patients in our mental health units.
How is it determined who is sent there? Each BOP institution is assigned a care level of 1 to 4, depending on its medical or mental health resources. When an individual at a Care Level 1, 2, or 3 institution requires a higher level of care than is available at that institution, his or her case is reviewed by BOP staff to determine where that
inmate should be housed. Each medical center has a unique mission, and placement is based on matching the medical and psychiatric needs of the inmate with the mission. At FMC Rochester, our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses. We have the same kinds of patients the state hospital did when it was open. We currently have 135 patients in our mental health units.
How do mental health services at an FMC differ from those offered at other correctional facilities? As a Care Level 4 institution, which offers the highest level of care, we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP. We have nurses on the units 24 hours a day, seven days a week. Each patient is assigned to a multidisciplinary team of professionals including a social worker, psychiatrist, psychologist, and recreation therapist. The patients meet individually with their team members regularly and with the entire team at least every 90 days. Due to the nature of their illnesses nearly all the patients are on psychiatric medications. Patients are offered a variety of therapeutic programming, including: art and music therapy; pet therapy; group therapy; employment in our sheltered workshop or some other work or vocational training; educational classes; drug and alcohol treatment; parenting classes, etc. Our patients reside in a therapeutic community, of which we, as treatment providers, are an integral part, as are the correctional staff. About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental disease or defect. These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment. Our goal for these patients is to improve their functioning to the point where they may eventually be placed back in their communities with the support services they need to stay stable and to keep the community safe. Typically these patients spend years with us. Some patients will never be well enough to leave, and will spend their lives with us.
Please talk about the day-to-day care you provide. As chief psychiatrist, I have administrative duties and I oversee the care of all the psychiatric patients. I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses. We have very dedicated nursing, social work, vocational, recreation, correctional, and psychology staff. My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit. I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers. Many of these patients suffer from neurocognitive difficulties.
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Minnesota Health care news November 2015
In addition, I, along with a mid-level provider, act as the primary medical providers for patients on our mental health units. We have tried other models of medical care, but found this to be the most effective way of providing the kind of integrated care these patients need. The patients are more comfortable with a provider
who knows their psychiatric condition and more important, knows them. We are sensitive to potential medication interactions, medication side effects, as well as potential medical complications associated with some psychiatric symptoms, such as psychogenic polydipsia. Of course, I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic.
can tell, likely never will be kept without a major shift in public and political will. Over 300,000 individuals with serious mental illnesses are incarcerated in this country, and most of them are not getting the treatment they need in or out of prison. That is unconscionable to me. On any given day over 5,000 individuals with mental illness are housed in the Los Angeles County Jail. New York City releases over 25,000 individuals Is there enough care for the patients? with mental illnesses from its jails each Yes. Our challenge comes when patients year, and most of these folks are released are releasing to the community. Many of Over 300,000 individuals with absolutely no resources. Jails and the patients come from socioeconomically prisons are designed and staffed to house with serious mental deprived backgrounds, and they may be individuals charged or convicted of crimes, returning to an area where there are only illnesses are incarcerated not to diagnose and treat severe mental minimal mental health services available. illnesses. Mental illness is not a choice. It in this country. Many are homeless and have no family is a chronic disease that needs treatment support, no financial resources, and nearly to reduce the suffering of its victims and to all are too functionally impaired to work full improve the safety of our communities. time. Our social workers devote their days to finding community resources for our patients, but it can be a very frustrating and heartrending job.
Respecting privacy concerns, can you share some success stories? Unfortunately, I cannot provide any specific case histo-
How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester?
ries, but I can tell you family members often say they have never seen their family member doing so well. They often express a great sense of relief that the person is finally getting the care they need. Our patients also frequently tell us we have provided the best care they have ever received, medically and psychiatrically. For me, the most rewarding moment is when a patient is releasing to the community and comes by to say “goodbye.” Invariably, he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients. I know then my goal to be a healing presence for the patients has been met.
We all have offices in the same building, and the nature of our work naturally brings us together frequently to discuss cases and consult with one another. We rely heavily on each other for assistance with especially challenging patients. We have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients. We have no productivity requirements, no worries about reimbursement, no one looking over our shoulders telling us how long a patient may stay with us. The patients’ needs drive our day, so that is our focus. It is really very straightforward.
How does the care you provide at an FMC differ from the care psychiatrists provide in private practice? First and foremost, we are able to get to know our patients over months to years. This makes an enormous difference in our ability to accurately diagnose and treat these severe, disabling conditions. Second, all medications are administered through directly observed therapy, and we know each day which patients did or did not take their medications. This allows us to intervene immediately and address the adherence issues as they arise.
It’s always
PERSONAL to us.
What kind of personal safety issues must be considered when working in a prison? Surprisingly, working in a prison is much safer for a psychiatrist than working in a community hospital or emergency department. Although some of our patients have committed acts of violence, these nearly always were when the patients were symptomatic. Because we know our patients so well, we know when they are decompensating. We emphasize safety and security above all else, and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons. This greatly reduces the risk of serious violence in our setting compared to the community. In my 21 years of working in prisons, I have only been assaulted one time, and that was by a female patient at our medical center in Texas. In my four years of training at the Mayo Clinic, I was assaulted more times than that! Finally, if a patient is losing control, we have various ways to call for help, and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance.
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Correctional facilities have been referred to as “the nation’s safety net for mental health care.” What can you tell us about this? We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings. The promise for community resources that was made when state hospitals closed was never kept, and as far as I
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November 2015 Minnesota Health care news
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air quality
Environmental Health
The effects of
Understanding the metrics By Monika Vadali, PhD
T
he term “air quality” is broadly used to describe the condition of air with relation to potential human health effects, visibility, odor, or potential for deterioration of man-made or natural structures. While Minnesota fares well in comparisons with other regions, it’s important to understand the factors contributing to air quality, the associated health risks, and the tools available to monitor daily conditions.
Terms and definitions Two terms are commonly used to discuss air quality: Pollutants are unwanted chemicals or other suspended particulates that are found in air in quantities high enough to potentially endanger the environment or human health. Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air. Air quality gets degraded as the amount of pollutants in air increases. This is called air pollution, and the substances causing the damage are called air pollutants. Air quality is influenced not only by the magnitude and quantity of air pollution sources, but also by environmental factors such as the movement of air masses due to weather conditions, temperature, and the amount of sunlight, and by the presence of buildings, water bodies, or mountains. Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm humans or the environment. When winds are sufficiently strong, pollutants are effectively dispersed and high concentrations are less likely. However, when pollutants are trapped due to weather conditions (inversions), terrain (mountains or buildings), or other features that limit the free movement of air, pollutant concentrations may increase to unhealthy levels, creating a poor air quality day.
Psychiatric Care evolved. 888-9-prairie
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The Environmental Protection Agency (EPA) has established a uniform Air Quality Index (AQI) for people to assess air quality on specific days and in specific locations. The Minnesota Pollution Control Agency (MPCA) posts a statewide AQI, based on these EPA standards, on its home page at www.pca.state.mn.us. Calculated from the worst-case measurement of five common air pollutants, the MPCA site includes a map color coded to show conditions throughout the state, along with links to display more detailed information. One screen allows users to view city-by-city levels of the five pollutants comprising the EPA’s Air Quality Index: • Particulate matter, ranging in size from 2.5 micrometers (PM2.5) to 10 micrometers (PM10)
• Ground-level ozone (O3)
of exposures, and the individual’s level of susceptibility. Generally, young children, pregnant women, and the elderly are the most atrisk populations. Two pollutants in particular are increasingly being studied for poor air quality-related health effects. These are particulates (PM2.5 and ultrafine) and ozone.
• Nitrogen dioxide (NO2) • Carbon monoxide (CO) • Sulfur dioxide (SO2) The local picture Minnesota’s air quality is generally good and has been improving for most pollutants. The poorest air quality in the state is found in the Minneapolis–St. Paul metropolitan area. The cleanest air is found in remote areas of northern Minnesota, where health risks from air pollution are as much as 100 times lower than in the Twin Cities urban core. Locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources. Minnesota currently meets all National Ambient Air Quality Standards, and trends show that concentrations of most pollutants have decreased over the last few decades. Toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually, although the cumulative effect of multiple pollutants is still a concern in some areas. While Minnesota meets the standards, research has shown that even low levels of air pollution, below the standards, may cause detrimental health effects.
The MPCA and the Minnesota Department of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county Twin Cities metro area. The report, “Life and Breath: How air pollution affects public health in the Twin Cities,” used baseline data from 2008, the year with the most recent data available that allowed for linking of air pollution levels and health outcomes. Although the air quality in Minnesota is currently good and meets federal standards, even low and moderate levels of air pollution can contribute to serious illnesses and early death. The analysis found that air pollution contributed to about 2,000 deaths, 400 hospitalizations, and 600 emergency room visits in the Twin Cities in 2008.
The Minneapolis–St. Paul metropolitan area has better air quality than most U.S. cities of similar size.
The effects of air quality to page 34
The Minneapolis–St. Paul metropolitan area has better air quality than most U.S. cities of similar size. The American Lung Association’s State of the Air 2013 study (www.stateoftheair.org/2013/ assets/ala-sota-2013.pdf), which ranked cities and counties across the country, gave Minnesota good grades for ozone pollution and average grades for particle pollution. Minnesota’s relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here, and much of the time our air comes in from unpolluted areas to the north and west. Since the enactment of the Clean Air Act in 1970 and Clean Air Act Amendments in 1977 and 1990, concentrations of traditional air pollutants have generally decreased. However, as scientists learn more about the health effects of these pollutants, standards have also become stricter, resulting in more air alert days. As the understanding of air pollution continues to evolve, new methods of environmental protection must be explored. It is becoming increasingly obvious that it is not enough to control single pollutants from individual sources. There is growing recognition of the need to reduce air pollution emissions from scattered, less regulated sources such as transportation and residential combustion. Health concerns There is evidence that air pollution is associated with many respiratory and cardiovascular diseases, including asthma, pneumonia, bronchitis, stroke, and heart attack. The severity of the effects depends on factors such as the type of pollutant, levels and duration November 2015 Minnesota Health care news
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Pulmonology
Bronchitis From common coughs to chronic disease By Heather Hamernick, MD
B
ronchitis is a very common illness that nearly everyone experiences at some point. It is caused by swelling and inflammation of the bronchi, which are the upper airways of the lungs. The main symptom of bronchitis is a cough, which may be dry or may bring up mucus (phlegm). Other symptoms can include wheezing, chest tightness, and fever that is usually less than 100.5°F. Some people also get a sore throat, headache, and body aches. The disease takes two forms: acute and chronic. Acute bronchitis Most often caused by a virus, acute bronchitis produces coughs that typically last about one to three weeks. Another term for acute
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Minnesota Health care news November 2015
bronchitis is a “chest cold.” The main difference between a common cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat, sinus congestion, and runny nose, whereas a bronchitis virus settles in the bronchi and produces a bothersome cough. Often, a virus can first produce a cold and then move into the chest to cause bronchitis symptoms. Bronchitis may also be caused by inhaling irritants such as pollution, smoke, or airborne chemicals. Avoiding these irritants usually helps the cough resolve. Some people are particularly susceptible to acute bronchitis. These include smokers; those with asthma or other underlying lung disease such as emphysema; and those with diminished immunity, including babies, pregnant women, the elderly, and those undergoing treatment for cancer or immune disorders. Viruses that cause acute bronchitis include rhinovirus, coronavirus, respiratory syncytial virus, and parainfluenza virus, all of which are easily spread from person to person. If you are ill with a cough, you should avoid situations that could spread your infection to others, such as schools, the workplace (especially if it involves being near other people), airplanes, and shopping. Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity. One special type of acute bronchitis is caused by the influenza virus, also known as “the flu.” When influenza virus infects the bronchi, the symptoms are usually more severe than typical bronchitis, and can include high fevers, severe fatigue, terrible body aches, and feeling very ill. There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people. The yearly influenza vaccine helps protect against this illness, and also protects against complications of influenza, including pneumonia and even heart attacks. Less than 1 percent of the time, bronchitis is caused by the bacterium Bordetella pertussis, resulting in the highly contagious disease known as pertussis or whooping cough. This should be suspected if the cough persists for at least two weeks, and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing. Whooping cough can be diagnosed with a nasal swab test in the doctor’s office. Since whooping cough is caused by bacteria, it may be treated with an antibiotic. Antibiotics are not effective against viruses, though, which are the leading cause of acute bronchitis. Unnecessary use of antibiotics
may also produce severe diarrhea and allergic reactions, and may build up resistance to future antibiotics. Instead, patients with viral forms of acute bronchitis should try to alleviate symptoms. That includes plenty of rest and fluids to keep well hydrated. Also commonly recommended: humidifiers, cough drops to help keep the throat moist, anti-pain and anti-fever medicines such as ibuprofen or acetaminophen, cough suppressants such as dextromethorphan, and mucus-thinning medication such as guaifenesin. These treatments are all available over the counter. Many people think that a cough with mucus production means there is a bacterial infection, but this is a myth. It is normal for a virus to cause mucus production, which can be clear, white, yellow, green, or brown. An antibiotic will not cure this. Sometimes, people expect to get an antibiotic for bronchitis because they got one the last time they had bronchitis and it seemed to make it go away. This is almost always a coincidence of timing, since bronchitis usually goes away within one to three weeks on its own.
there is no cure that can make it go away faster. You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovementioned treatments. However, some people should go to the doctor when they get bronchitis. They include: children six months and under, pregnant women, adults age 65 and older, people with asthma or emphysema or any other chronic lung condition, heavy smokers, heavy drinkers of alcohol, and anyone else with a compromised immune system. These people are more likely to get a complication of bronchitis such as pneumonia.
Antibiotics are not effective against the viruses that cause most cases of acute bronchitis.
Acute bronchitis can be miserable and patients often seek medical care because the cough is causing lack of sleep, missed work or school, and trouble talking or exercising. Most healthy people with acute bronchitis will get over it within a few weeks, though, and
There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis. These include: a fever above 100.4°F that lasts longer than 24 hours, increasing or severe shortness of breath, coughing up blood, a cough that lasts longer than three to four weeks, and recurrent episodes of bronchitis.
The best ways to prevent acute bronchitis are to not smoke, to wash hands frequently, especially during cold and flu season, and to avoid contact with other people who are coughing. A fairly common complication of acute bronchitis is called the “post infectious cough.” This is characterized by a lingering dry Bronchitis to page 32
Minnesota Optometric Association
Doctors on the frontline of eye and vision care Did you know?
• Diabetic retinopathy can be controlled and diabetic patients need regular eye exams to maintain vision and good eye health. • Diabetes Type ll can also cause vision changes. • Glaucoma must be diagnosed in early stages in order to prevent vision loss. • All children entering school need a comprehensive eye exam, because vision screenings do not detect a number of eye disorders. • To maintain eye health, everybody from babies to boomers to older adults needs a regular eye exam by a family eye doctor. To locate an optometrist near you and find comprehensive information about eye health visit http://Minnesota.aoa.org November 2015 Minnesota Health care news
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Oncology
Skin
cancer Prevention, detection, and treatment By Kathryn Barlow, MD, and Julie Cronk, MD
S
kin cancer is the most common form of cancer in the U.S. In 2015, 2.2 million Americans will be diagnosed with either basal cell, by far the most common, or squamous cell carcinoma, according to the American Cancer Society. Another 73,870 will be diagnosed with malignant melanoma. It is more important than ever to know the warning signs of these cancers, their treatments, and preventive steps you can take. Prevention Despite the staggering numbers, skin cancer is one of the most preventable forms of cancer. Regular use of sunscreen, protective
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Minnesota Health care news November 2015
hats, and clothing is key to skin cancer prevention. The best thing you can do is to apply a broad-spectrum sunscreen. Check labels for products that filter both UVA and UVB light, with SPF ratings of 30 or higher. Apply 30 minutes before going out in the sun, and again after 30 minutes of continual exposure. Remember that sunscreen needs to be reapplied every two hours or immediately after swimming or heavy sweating. Skin cancers and treatment Actinic keratosis (AK), a type of precancer, occurs when UV light damages skin cells. AKs are rough, dry, or scaly areas that develop over sun-exposed skin, and are considered precancerous lesions. Some studies have shown that topical retinoids, derivatives of vitamin A in prescription creams often used for acne, can treat precancers as well as improve signs of sun damage. Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage. Although we’re learning more about the benefits of vitamin A and vitamin C, we typically recommend proven in-office treatments. Your dermatologist may use liquid nitrogen to “freeze” and kill the bad cells. If you have multiple AKs, your dermatologist may recommend photodynamic therapy or “blue-light.” After a topical medication is applied to the AKs to render them more sensitive to light, the area is exposed to a specific wavelength of visible, non-UV light, destroying the precancer cells. This type of therapy is also used in some cases of more advanced skin cancers. To treat some AKs, we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU), applied over a two- to four-week period. Imiquimod, a topical immune-stimulator, causes a localized immune response in the skin to combat AKs. Ingenol mebutate, a derivative of a plant sap, and diclofenac, a topical medication with an
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ingredient similar to ibuprofen or other nonsteroidal anti-inflammatory drugs, are also used topically to treat and remove AKs. If more conservative treatments fail, carbon dioxide lasers can be employed to remove layers of skin, “resurfacing” it to remove AKs. Basal cell carcinoma (BCC), the most common type of skin cancer, usually starts as a sore or “pimple” that does not heal. BCC is common in areas of chronic sun exposure. BCCs are usually pink, translucent, or skin colored, although some can be more scar-like in appearance or may be flat, scaly, and red. BCCs bleed easily when rubbed or even when washed. Although they are usually slow-growing tumors, they must be removed or they will continue to grow deeper and wider. Basal cell carcinoma rarely spreads to other parts of the body, but if you’ve had one BCC you have about a 40 percent chance of having another one.
any area with remaining tumor and remove more skin from just that area. Once the entire tumor is removed, the doctor can then repair the area, or it may heal by itself. This method is reserved for specific locations such as the head and neck, hands and feet, or other areas that require sparing as much normal skin as possible. It is also used for more aggressive or larger tumors and tumors in persons with suppressed immune systems.
Skin cancer is one of the most preventable forms of cancer.
Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs), and are also related to chronic sun exposure. They usually appear as a wart or scaly pink bump that may be tender and may bleed. These tumors have a higher chance of metastasizing than BCC, but the overall risk is still low.
Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize. The American Cancer Society estimates there will be 73,870 cases in 2015 and 9,940 deaths. Melanoma lesions are usually dark, irregular spots that can start as a new mole or are an existing mole that has begun to change. Because melanoma can be life threatening, you need to watch for these “ABCDE” signs in new or changing moles: • A symmetry, in which the two halves of the lesion do not match. • B orders that are irregular or jagged rather than smooth and even. • C olors that are varied and multiple, including various shades of brown, blue, black, or even sometimes red. • D iameters that are greater than that of a pencil eraser (6mm). Keep in mind that melanomas can also be smaller than this, however. • Evolution or change to any mole. Surgical and nonsurgical approaches The good news is that BCCs and SCCs are easily treated, especially when diagnosed early when the lesion is small. There are several methods of treating these cancers, and your dermatologist can help you decide which method is best given the location, tumor type, and other characteristics. Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate. This procedure involves numbing the area with a local anesthetic, then removing the tumor along with a small rim of normal tissue. The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins. The dermatologist, who should have specific training for Mohs surgery, can then go back to
Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas. Most melanomas are also treated with this method. The surgeon takes an appropriate margin of normal skin and usually closes the area with stitches. Certain patients with melanoma may also require surgical removal of a lymph node, which is examined for spread of the cancer. Fortunately, recent research has given doctors new drugs to use for cases of metastatic melanoma. Before these discoveries, there were limited treatments for more serious cases of melanoma.
Many basal cell carcinomas and superficial, less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or “scrape and burn.” This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or Skin cancer to page 19
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763.647.0042 suzy@schellerlegalsolutions.com
www.schellerlegalsolutions.com November 2015 Minnesota Health care news
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Calendar Nov.-Dec. 2015 Nov.18
Scleroderma Support Group
The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns, information, peer support, and encouragement. For more information, call Karen at (952) 926-8848. Wednesday, Nov. 18, 6 –7:30 p.m., Southdale Medical Building, Rm. C-62A, 6545 France Ave. S., Edina
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Binge Eating Disorder Class
Park Nicollet’s Melrose Center offers this free information session for anyone who would like to learn what binge eating disorder is and what treatments are available. No registration required. Call 952-993-1000 for more information. Thursday, Nov. 19, 6 – 7 p.m., Melrose Center, 3525 Monterey Dr., St. Louis Park
Dec.2
Weight Loss Surgery Support Group
The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery, or those who are considering it. No registration necessary. Friends and family members welcome. Call (612) 626-6666 for more information. Wednesday, Dec. 2, 6:30–8 p.m., University of Minnesota Medical Center, East Building—Brennan Center, 2450 Riverside Ave., Minneapolis
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International Survivors of Suicide Loss Day International Survivors of Suicide Loss Day (Nov. 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find comfort, healing, and support. More than 41,000 suicides occurred in the U.S. in 2013, according to the Centers for Disease Control and Prevention, making it the 10th leading cause of death in the country. Suicide almost always results from the pain and desperation of a mental illness, according to the American Foundation for Suicide Prevention (AFSP), which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time. When a friend or loved one takes their own life, it can leave a lot of unanswered questions and a range of intense emotions, including loneliness, pain, grief, anger, sadness, and guilt. Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process. Find more information and resources at www.afsp.org.
Parkinson’s Disease Support Group
Allina Health offers this free 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 at (612) 273-3868 to sign up or for more information. Friday, Dec. 4, 1–3 p.m., Fairview Rehab Services, 2200 University Ave. W., Ste. 140, St. Paul
Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Email submissions to amarlow@mppub.com or fax them to (612) 728-8601. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.
Dec.3
Survivors of Suicide Support Group
Have you experienced the death of a loved one through suicide? This support group, hosted by Bradshaw Grief Resource Center, will connect you with other individuals and families who understand. For more information, call (651) 489-1349. Thursday, Dec. 3, 7–8 p.m., Bradshaw Group, 4600 Greenhaven Dr., White Bear Lake
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Coping with Cancer Recurrence
Park Nicollet presents this free class for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences. Call (952) 993-5700 to sign up. Tuesday, Dec. 8, 10:30–11:30 a.m., Park Nicollet Frauenshuh Cancer Center, Curtis & Arlene Carlson Family Community Rm., 3931 Louisiana Ave. S., St. Louis Park
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Car Seat Clinic
HealthPartners offers this free class to teach parents and caregivers how to install and use child car restraints. Seven out of 10 car and booster seats are installed incorrectly, according to the Minnesota Department of Public Safety. Come learn the correct way from trained technicians. Call (651) 357-2798 to set an appointment time. Thursday, Dec. 10, Regions Hospital, 640 Jackson St., St. Paul
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Brain Tumor Support Group
HealthEast hosts this free support group for brain tumor survivors and their loved ones. Join the informal group discussion for support, education, and a source of hope and encouragement. No registration required; other dates are available. Call Kathy at (651) 232-3987 to sign up or for more information. Monday, Dec. 21, 7–8:30 p.m., St. Joseph’s Hospital, 3M Conference Center, Rms. A/B, 45 W. 10th St., St. Paul
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Parents of Children with Special Needs Group
Arc Greater Twin Cities hosts this free networking group for parents of children with all types of intellectual and developmental disabilities. Come meet others in similar situations and gain insights from their experiences. For more information or to sign up, call at (952) 920-0855. Monday, Dec. 28, 6–8 p.m., Therapy OPS, 2925 Buckley Way, Inver Grove Heights
America’s leading source of health information online 18
Minnesota Health care news November 2015
Skin cancer from page 17
burning. This method is quick and simple, and the area heals in a couple of weeks.
also used for several weeks and has some of the same side effects we see with Imiquimod. Finally, there are a couple of oral medications that have been approved for the treatment of advanced or metastatic BCC. These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body. Cure rates with these drugs are lower than with surgery and side effects can limit their use.
Some BCCs and SCCs can be treated by nonsurgical methods. Photodynamic therapy may be used to treat some superficial types of BCC/SCC, usually in several sessions. When lesions are superficial, an anticancer cream can sometimes be used. The advantage to this method is that the risk of scarring is greatly reduced. The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods, especially if the tumor is deeper or more aggressive. One of the anticancer creams involves immunotherapy, a form of cancer treatment that uses your body’s immune system to attack cancer cells. Imiquimod draws your immune system’s attention to the area to kill the cancer cells with interferon. It can make the treated area become red and irritated, but that ceases when you stop using the medication. A course of treatment usually lasts several weeks.
Recent research has given doctors new drugs to use.
Chemotherapy cream is another way to treat certain superficial skin cancers. 5-fluorouracil is a topical chemotherapy cream that is
Conclusion Knowing how skin cancer is treated is important. However, the best way to treat skin cancer is to avoid getting it in the first place! Skin cancer is preventable with proper use of sunscreen, avoiding tanning beds, and seeing your doctor every year for a full-body skin screening. And if you see any mole that is changing, bleeding, or itching, make an appointment with your dermatologist.
Kathryn Barlow, MD, and Julie Cronk, MD, are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatology Consultants. Dr. Cronk is also a fellow of the American College of Mohs Surgery.
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November 2015 Minnesota Health care news 9/14/15 9:03 19 AM
Home Care
Helping seniors live healthier, happier lives By Angela Nelson, RN
B
etty nervously waits in the doctor’s office for them to call her name. She’s had an eventful couple of weeks. Her husband died only a month ago and last week she ended up in the emergency room (ER) after she fell in her kitchen. With everything that was going on, she forgot to fill her prescription. As she sits there, she holds on tight to her purse, which contains a complete list of her current medications (did she remember all of them?) as her thoughts wander to her recent trip to the ER—she’s fearful the doctors will suggest she stop driving. Without a car, how will she
get to the store, church, or knitting group—she looks forward to that group each week. Instantly she feels sad, for the second time this month, and worries about her independence eroding. Finally, her name is called and she’s in the clinic exam room. An hour later she’s in her car thinking, “Why didn’t I ask the questions I had? What’s this new medication supposed to do again? Am I calling the occupational therapist or are they?” Her mind wanders again—“Has it really been just a few weeks since Joe died? I need to stop at his grave on my way home. Funny, the doctor never asked about that.” A few weeks later, Betty ends up in the hospital. And the cycle continues. A growing problem Betty’s situation is an example of an all-too-familiar experience shared by seniors and those who care for them, most often their adult children. This roller coaster of health care crisis is costing seniors more than they realize, hitting not just their finances but also their quality of life. In 2014, nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month, costing an estimated $26 billion. Of that amount, $17 billion represented readmissions that were potentially avoidable. This readmission impact has hit 27 percent of Minnesota hospitals, with 36 facilities being penalized for high readmission rates. As Betty’s example illustrates, it isn’t just a “health care” issue—it is a life issue. A study by researchers at Boston’s Beth Israel Deaconess Medical Center (Annals of Internal Medicine, June 2015) found that many of the risk factors for readmissions, especially those occurring eight days or longer after discharge, are beyond the typical scope of hospital efforts, with many involving socioeconomic status or access to personal support systems. There is widespread recognition of the need for change. Ten years ago, Lifesprk began building a new model to do exactly that: start with people’s individual wishes and goals, then use a whole person approach combined with ongoing advocacy and guidance. A new approach: Life care managers Imagine the difference if Betty had had someone with her at her doctor’s appointment. Better yet, if she had a nurse by her side who
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Minnesota Health care news November 2015
would ask the right questions, record the information, and relay that information to Betty’s family. The nurse would help Betty and her family keep the focus on her goals and wishes, taking a whole person approach to get to know Betty and what matters most to her. The nurse would be an advocate in the midst of all of Betty’s life changes, regardless of whether she was at home, in the doctor’s office, in the hospital, or even in a nursing home. Nurses like this are called life care managers (LCMs). We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach. LCMs carefully monitor seniors’ health to make sure small issues don’t become larger ones. This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs. It’s also helping seniors to live healthier, more independent lives, something Lifesprk calls living a “sparked life.”
with data from one year after these services, the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients. While many factors contribute to this reduction, one of the key factors for this success is the use of an LCM who is trained to address not only any concerns seniors face but also their individual goals, purpose, and passion. The LCM role LCMs become the trusted advocate for a person’s whole life—encompassing everything from health and wellness to purpose and passion. It all starts with an innovative discovery process. In Betty’s case, long before she ended up in the physician’s waiting room, the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals. Those goals can be as simple as continuing to attend church and her knitting group each week, or as complex as travel and regaining the strength to walk. Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals.
LCMs cross all settings and work with every type of provider.
In 2014, Lifesprk conducted a baseline study to document the impact of its whole person senior care approach. We tracked hospitalizations and ER visits, as well as quality of life indicators such as connectedness, happiness, control, and engagement. Comparing data on client experiences in the year prior to our services
Life care managers to page 30
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Behavioral Health
Online mental health services Click here for therapy By Richard F. Sethre, PsyD, LP, and Deb Rich, PhD, LP, CPLC
H
ealth care providers regularly communicate with their patients through online portals, email and text messages, video discussions, and more. Much of this communication involves routine matters, but in the case of mental health assessment and treatment, the telehealth umbrella has expanded to include
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Minnesota Health care news November 2015
actual, ongoing therapy sessions—an arrangement that seems to work for patients and providers on both ends of the line. A growing trend All telehealth services require an adjustment to new technology. For mental health services, the adjustment goes beyond connection speeds and web savvy. Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person, and sharing these private matters in a video discussion may seem threatening at first. For this reason, when telehealth services were first developed, most medical professionals thought that they could be most helpful for superficial communications, such as routine check-in appointments with a primary medical professional. The very notion of delivering mental health assessments—or providing ongoing mental health treatment—via telehealth services was considered to be too radical for both patients and their mental health professionals. To the surprise of many, this turned out not to be the case. Adventuresome mental health professionals and their patients gradually eased into video sessions, finding, to their surprise, that video sessions actually can work very well. Research supports this observation. One recent report examined 92 studies comparing Internet-based therapy with in-person therapy, concluding that the differences between the two were “not statistically significant”— overall, they were about equal with regard to both effectiveness and patient satisfaction. A separate review of 148 studies focusing on video mental health therapy revealed high levels of patient satisfaction. Patient experiences There are several possible reasons that video mental health sessions could be preferable to in-person sessions. For example, many Minnesotans live in parts of the state that are underserved by mental health providers. Video sessions allow them to receive much-needed mental health services in their community, avoiding long-distance travel to the closest mental health clinic, which could be in another county or
several hours away from home. Other patients may lack transportation or have mobility problems that limit their ability to drive, or suffer from chronic pain or chronic weakness. All of these patients may find it difficult, or even impossible, to use the limited transportation options available to them, and many welcome the opportunity to see their mental health professional in the comfort of their own home. People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also prefer video sessions. At some point in their treatment it will be necessary for them to venture out to face their anxieties, but early on in their treatment, it actually may be preferable for them to remain in the safety of their home.
Before you log on If you are interested in trying video mental health services, here is what you should know: • You will need to confirm that your insurance company covers telehealth services, and that it will pay for video mental health services. Due to increasing awareness of the benefits to patients and the cost savings to insurers, an increasing number of insurance companies are doing so—but confirm this before you start.
Confirm that your insurance company covers telehealth services.
While not always possible, most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions. This may vary with age, though: Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook, FaceTime, and other social networking tools. Other people who have come to expect the convenience of social networking, online shopping, and other digital conveniences may expect—and even demand—the same level of convenience for their mental health needs.
Some individual patients are in particular need of video mental health services. One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy, or who have required extensive treatment in the hope of getting pregnant. She has been contacted by women who live in remote rural areas in the U.S. or live abroad. They may have arranged for periodic travel to a central area for standard prenatal care. However, once having experienced significant medical and emotional challenges, they may become desperate for the help of a specialist. Without access to her video services, these patients would have remained isolated and without adequate care. She has found video sessions to be remarkably effective and appreciated. Her patients usually reach out by email and are able to schedule a session within days. Intake forms and financial contracts are all handled by email. The therapy is supplemented with vetted websites for resource information and support. Most of these patients have shown dramatic improvement with just a few sessions. Without timely access to her specialty telehealth services, these women may have unnecessarily struggled with tragic circumstances and treatable conditions.
• You will need to find a psychiatrist or therapist who has the interest, skills, and resources to provide video services. Contacting your insurance company or doing an online search will help you locate these professionals.
• If possible, it is helpful to meet at least once in person. This helps to build comfort for both the patient and the mental health professional, but may not always be possible when the patient is in a remote area, has serious mobility problems, or is highly anxious about leaving the home. • T herapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing Online mental health services to page 31
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Video mental health sessions may also be very beneficial for people in urban areas, who may have adequate access to mental health services but are busy with work or family needs. Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions. For others who cannot afford the travel necessary to get to in-person appointments, video sessions can encourage them to seek the help they need. November 2015 Minnesota Health care news
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Hematology
Anemia Simple fatigue, or something more serious? By Julie Anderson, MD, FAAFP, CIC
“J
ane Smith” is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam. She is concerned because she has felt tired and weak for the last few months. At times, she is short of breath and her friends have even commented that she appears pale. As patients often do, she has done some of her own research online. Could it be anemia, she asks?
This is a common question for physicians to address. Although there are a multitude of causes for fatigue, anemia is certainly one possibility. Jane’s doctor gets her complete history and performs a thorough examination. When her blood count test comes back with a low hemoglobin count of 9.5, Jane’s suspicion of anemia is confirmed. So, now what? What is the next step? Before her family doctor can pursue treatment options with Jane, it is important to review the definition of anemia, address symptoms and risk factors, and attempt to determine the cause. Definition and symptoms Anemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body. Anemia can be caused by inadequate production of red blood cells, blood loss, or the inappropriate destruction of red blood cells in the body. Based on the cause, anemia may be a temporary problem or it can continue over several years.
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Minnesota Health care news November 2015
The red blood cells, made in the bones, carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues. A normal hemoglobin level is 12 to 16 gm/dL for women and 14 to 18 gm/dL for men. Anemia can vary in severity. If the hemoglobin loss is gradual over time, it may not be recognized until it is profoundly low. Symptoms of anemia are varied, but most people will experience fatigue and weakness. Other common symptoms include pale skin, rapid heartbeat, shortness of breath, chest discomfort, or headache. It is important to note that some people have no symptoms at all. For example, a patient like Jane may donate blood and then be told that her counts are “off.” In this case, the physician may ask Jane if she has a family history of anemia, such as thalassemia or sickle cell anemia, or a bleeding disorder, any of which could lead to inappropriate loss of blood. The physician should also question if she is taking a blood thinner like aspirin, which can lead to bleeding in the intestine. It would also be prudent to ask about Jane’s menstrual cycle and the possibility of pregnancy, as both may provide a clue to the underlying cause of her low hemoglobin levels.
Vitamin deficiencies With hundreds of different known types of anemia to consider, searching for the source can be daunting. Many cases of anemia are due to vitamin deficiency, which, as the name implies, results from inadequate levels of certain vitamins in the body. Iron deficiency, the most common of vitamin deficiencies, can be caused by blood loss from injury, heavy periods, colon polyps, or ulcers, as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohn’s disease or celiac disease. It may also be due to a diet deficient in iron, and typically is treated with iron replacement. Deficiencies of other vitamins, including folic acid and B12, can also cause anemia. If Jane is an alcoholic, there is a good chance this could be an underlying cause of this type of anemia. Some patients get plenty of B12 in their diet, but their bodies do not absorb the vitamin adequately, resulting in the more rare illness known as pernicious anemia.
vegetables, should be taken with vitamin C, which aids in the absorption of iron. Folate may be found in fruits, vegetables, and cereals. B12 is often fortified in foods. Medical conditions Because virtually any chronic medical condition can affect the production of red blood cells, many people with chronic illness also suffer from anemia. In patients with kidney disease, cancers, and inflammatory disorders, physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood, and by ruling out other sources of low hemoglobin. Therefore, it is important for patients to tell their doctors about any past medical problems, as these may provide a clue to the cause of the anemia. Before concluding that the chronic disease is the cause of anemia, it is worth investigating other potential causes. “Anemia of chronic disease” is typically a diagnosis made only after all others are excluded.
Anemia may be a temporary problem or it can continue over several years.
Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame. If so, treatment would consist of replacement of the appropriate vitamin. Iron-rich foods, including meat, beans, and dark leafy
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Other types of anemia may be caused by improper manufacturing of the red blood cells, as is the case in various diseases such as multiple myeloma, myelodysplasia, or leukemia. If these conditions are suspected, the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow. Anemia to page 29 Age 76 Squamous Cell Carcinoma
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End-of-Life Issues
Advance care planning Specify your wishes now By Thaddeus Mason Pope, JD, PhD
W
hat will happen if you experience a serious illness that prevents you from making your own health care decisions? How will you ensure that you receive the kind of care you want? Will your family know enough about your values to feel comfortable making medical decisions on your behalf? To adequately address these questions, every adult Minnesotan should do advance care planning (ACP). MSA - MN Healthcare July 2013.pdf 1 6/12/13 15:23
Advance care planning is important At some point, serious illness will probably prevent you from being able to make or communicate your own health care decisions. You will lose decision making “capacity,” the ability to understand the significant benefits, risks, and alternatives to proposed health care and to make and communicate a health care decision. You will be unable to direct your medical care. Unless you plan for this, you will likely be treated in ways and in settings that you do not want. Fortunately, you can take steps, now, to make your “voice” heard later. Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes. Because ACP allows you to specify in advance how you want to be treated, it helps assure that you receive medical care aligned with your values and preferences. The goal is to ensure both that you get the care you want and that you avoid the care you do not want. ACP is a multistep process. First, have multiple conversations with your family, friends, and clinicians to explore and consider your health care values and goals. For example, if you were dying, how important would it be to avoid pain and suffering, even if it means that you might not live as long? How important is it to be alert, even if it means that you might be in pain? Would you rather be more conscious and have some pain? Or would you rather have less pain and be groggier? Once you have identified your values and goals, you need to communicate them. There are three main objectives: 1) choose your health care agent, 2) document your preferences and values, and 3) translate your preferences and values into medical orders. Choose your own health care agent. When you are unable to make your own medical decisions, you will want to select someone whom you trust to make those decisions on your behalf. If you do not make a selection, one will be made for you. But that is a risky approach. The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes. Choose your own health care agent.
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In Minnesota the main written legal instrument for identifying a substitute decision maker is the “health care directive.” This is a Minnesota Health care news November 2015
simple form that includes a health care power of attorney by which you can formally appoint your “health care agent.” You should probably also designate one or more alternate back-up agents, in case your first named agent is not reasonably available to serve.
easy to follow. Second, POLST follows the person in any care setting (hospital, nursing home, residence). Third, unlike an advance health care directive, POLST is intended to apply immediately, not only upon the satisfaction of certain specified conditions.
By appointing an agent, you are not surrendering any control. Your agents will not have authority to make health care decisions for you, unless you lack decision-making capacity. If you can decide and speak for yourself, clinicians will look to you, not to your agents. Furthermore, even when they have authority, your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent. Finally, note that health care directives cover only health care decisions. They have no effect over financial affairs that are unrelated to your health care.
Readers may recall the August 2015 case in which Maplewood paramedics stopped resuscitation efforts on a 71-yearold nursing home resident at her husband’s request. Those paramedics were later placed on administrative leave. Emergency workers like EMTs and paramedics are legally required to prolong the lives of dying patients unless they have a specific order from a physician. A POLST is such an order. An advance health care directive is not.
Every adult Minnesotan should have an advance health care directive.
Document your preferences and values. In the same health care directive through which you appoint your health care agent, you can also include health care “instructions.” This part of the directive used to be known as a “living will.” These instructions are written statements of your values, preferences, or guidelines regarding health care. Typically, these specify what medical treatment you do or do not want under certain stated medical circumstances. For example, would you want to be maintained on a mechanical ventilator (breathing machine), if you were permanently unconscious? Would you want medicine to treat pneumonia, if you had the incurable brain illness known as Alzheimer’s and were unable to recognize your family or carry on a conversation? The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living. While most health care directive instructions are about medical treatment, you can also include two other types of instructions. First, you can clarify your intentions regarding anatomical gifts. Do you want to donate any parts of your body, including organs, tissues, and eyes when you die? Second, you can clarify your intentions regarding funeral practices. What do you want to happen with your body (burial, cremation)? Translate your preferences and values into medical orders. Every adult Minnesotan should have an advance health care directive. But some Minnesotans should not stop there. In addition, those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for Life-Sustaining Treatment (POLST). POLST is designed to document wishes only in the final stages of life. So, it is appropriate only when death within the next year would not be unexpected.
Periodically update your planning documents ACP is not a one-time event but an ongoing process. As your life circumstances change, so may your health care preferences. Experts recommend that you revisit your ACP documents at any of the five D’s: every decade, at the death of a loved one, divorce, new diagnosis, or significant decline in condition. You can always change your Advance care planning to page 28
In the next issue... Your Guide to Consumer Information
• Preventing Winter Falls • Prostate Cancer • Rotator cuff injuries
POLST has several advantages. First, while there are dozens of advance directive forms, there is a single standardized Minnesota POLST. It is only one double-sided page, usually on bright pink paper. This uniformity and simplicity makes the form easy to find and November 2015 Minnesota Health care news
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Advance care planning from page 27
mind about the care you want by revoking or updating your health care directive or POLST. Local ACP resources While completing a health care directive is a standard part of any estate planning discussion, you do not need a lawyer. Numerous ready-to-use resources are available to guide and record your advance care planning. First, several Minnesota state government agencies (like the Department of Health and the Attorney General’s Office) provide ACP materials. Second, most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites. Third, many religious organizations distribute their own ACP materials. Fourth, dozens of expert nonprofit organizations offer their ACP resources for free. Some of the most effective and respected are listed in the sidebar.
Advance care plannning is not a one-time event but an ongoing process.
and fears regarding their end-of-life care. After all, they are paid more for doing, than for just talking. While some private insurers already pay for ACP consultations, this year, Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan. 1, 2016. Since most private insurers follow Medicare’s lead, ACP should soon be far more available. Summary Plan your future medical care. Discuss your end-of-life wishes and put them in writing. These are not easy issues to talk about. But they are some of the most important discussions that you will ever have. Your wishes cannot be followed, if no one knows what they are. Thaddeus Mason Pope, JD, PhD, is director of the Health Law Institute at Hamline University.
Advance Care Planning Resources ABA Consumer’s Toolkit: www.americanbar.org/groups/law_aging/resources.html Conversation Project: theconversationproject.org Five Wishes: www.agingwithdignity.org/five-wishes.php Honoring Choices Minnesota: www.honoringchoices.org
Medicare coverage is coming For decades, physicians and other clinicians have been reluctant to take the necessary time to carefully address patients’ wishes, goals,
National Health Care Decisions Day: www.nhdd.org POLST Minnesota: www.polstmn.org
“Multiple sclerosis upended the plans I had, forcing me to face uncertainty. I’ve learned to adapt and focus on what’s truly important to me.” — Susan, diagnosed in 1995
MS = dreams lost. dreams rebuilt. What does MS equal to you? Join the Movement® at MSsociety.org pubed11_MNHealthAd.indd 1
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Anemia from page 25
Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over. This can be the result of infection, cancer, medications, or inherited conditions affecting the body’s hemoglobin, such as thalassemia or sickle cell disease. In patients with these latter two conditions, the blood count may suggest iron deficiency, leading health care providers to treat them inappropriately with iron. Therefore, it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them.
Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications, while treatment of thalassemia may require blood transfusions or removal of the spleen. In general, if an underlying source cannot be found after a physical examination, a review of the patient’s history, and a laboratory evaluation, it is important for the physician to investigate sources of internal bleeding. This may include an upper endoscopy of the stomach and small intestine, as well as a colonoscopy.
Some people have no symptoms at all.
Thalassemia, a blood disorder affecting the production of hemoglobin, is inherited in a recessive manner. This means that if both of your parents carry a gene, you have a one in four chance to inherit the condition. Millions of people, particularly those of Mediterranean descent, carry a beta-thalassemia genetic trait. Sickle cell disease, another recessive genetic disorder, causes the red blood cells to take on an unusual shape. It also makes it difficult for the red cells to carry hemoglobin, and therefore oxygen, around the body. This condition can lead to many health problems, including severe pain caused by blood vessel constriction, stroke, or even death. Most people with the sickle cell trait are of African descent. The National Institute of Health states that about one in 5,000 people in the U.S. have sickle cell disease.
Getting back to our patient In the case of “Jane Smith,” her family physician determined that it was her heavy menstrual periods that were causing her anemia. She was treated with hormone therapy and iron replacement. Jane’s doctor reviewed the importance of a follow-up appointment with her. When she returned for another visit a few months later, her anemia had been resolved. Both the physician and patient were thankful that her symptoms had disappeared, and because of proper treatment and communication between Jane and her doctor, she is feeling better and is left with a greater understanding about her health.
Julie Anderson, MD, FAAFP, CIC, is a board-certified family physician at St. Cloud Medical Group. She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation.
November 2015 Minnesota Health care news
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Life care managers from page 21
In the clinic, her LCM would have held her hand, written down her concerns, and listened as Betty shared stories of her husband. The LCM would have guided the questions during her appointment, then recorded and explained what it all meant so that Betty could incorporate the physician’s orders into her daily life. Another important role of the LCM is to keep families informed of health changes and updates, helping to ease the burden of coordination and caregiving demands on the family. The LCM also serves as a hub for the team of providers involved in the client’s care—a service that is often missing or provided only on a short-term basis under other senior care models. LCMs cross all settings and work with every type of provider. They become the eyes and ears in the client’s home, providing hands-on support to implement the physician’s care plan at home and address critical needs such as support for physician appointments and medication management. They also address psychosocial and non-medical needs such as purpose and passion, which are powerful ways to keep people active, in control, and healthy. Remember Betty’s passion for knitting?
LCMs not only help with social supports but they encourage them. Knowing that life can still continue according to their wishes and goals, even as their functionality may change, gives seniors a heightened sense of wellbeing because they are engaged and happy. This sense of purpose focuses their mind not on what’s ailing them, but on the meaning and richness of their life. Hope for the future The National Institutes of Health stresses the need “for proven treatments and approaches that not only provide measurable outcomes but also take into account patients’ wishes and preferences.” While Betty’s story paints a common picture of today’s senior, there is hope that, with new innovations and approaches to care, providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis. Research shows that whole person senior care does in fact work to keep people out of the hospital and living healthier, more independent lives.
Telephone Equipment Distribution (TED) Program
Whole person senior care does in fact work.
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.
PUT THE SQUEEZE ON HIGH BLOOD PRESSURE If you have diabetes, controlling your blood pressure can help protect you from heart attack, stroke, blindness and kidney disease
• Track your blood pressure and share with your doctor • Medicines can make a difference... if you take them
1-800-657-3663 www.tedprogram.org
• Eat healthy and be active
Duluth • Mankato • Metro Moorhead • St. Cloud
• Do not smoke
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
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Angela Nelson, RN, is director of community life care management for Lifesprk.
Minnesota Health care news November 2015
• Avoid salt Minnesota Diabetes & Heart Health Collaborative
The Minnesota Diabetes and Heart Health Collaborative: Working together to keep you informed
www.mn-dc.org Adapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard
Online mental health services from page 23
board. You should expect the therapist to review this with you. If in doubt, be sure to ask about this. • Ensuring privacy and confidentiality is always crucial for all mental health services, and video sessions require a higher level of attention to these issues. You will need to determine whether you can use Skype or other online conferencing tools, for example. You should ask the mental health professional whether video sessions are encrypted, and whether the sessions are saved as part of the treatment record.
Video sessions can provide convenient, productive access to mental health services.
• You and your professional will need to have plans to handle technological problems as well as issues that arise during the session. For example, you will need a computer and Internet connection that are adequate for video conferencing. Since even the best technology will fail at times, you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the connection is reestablished). In particular, the professional will need
Discover
to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online. This usually involves having a plan for reaching out to friends or loved ones, or allowing the professional to reach out to them and to have them check in with you. Conclusion Research consistently finds that when mental health patients receive appropriate mental health services at the time they need them, they feel and do better. In addition, timely mental health services often reduce medical and other social expenses in the long run. Video sessions can provide convenient, productive access to mental health services that might otherwise not be available, and can effectively serve patients while reducing medical expenses. Richard F. Sethre, PsyD, LP, is a licensed psychologist and practice management consultant in Golden Valley, with a special focus on health care psychology. His Mental Health Concierge blog provides resources for consumers and professionals. Deb Rich, PhD, LP, CPLC, is a licensed psychologist in St. Paul specializing in reproductive health psychology. She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach.
Have You heard about the BioMat?
the benets of yoga.
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This amazing medical-grade infrared heating mat can change your life for the better. It is used in homes and professional healing practices all over the world. The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic conditions that have not responded well to medication therapy.
A brief overview of benefits from using the BioMat:
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• Stress and anxiety relief
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BioMat Professional 74"x28" $1,650.00
We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason. If you order through us, you will also receive a 30 year repair guarantee and lifetime trade-in policy.
866.689.7336 For more details please visit: www.crystalbiomat.com November 2015 Minnesota Health care news
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Bronchitis from page 15
cough despite healing from the virus of bronchitis. It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue. It can sometimes last eight weeks or even longer, but should not be accompanied by any fevers, chills, sweats, weight loss, or significant shortness of breath. It is essential to see a doctor for any cough that lasts eight weeks or more, even if no other concerning symptoms are present. Chronic bronchitis Defined by coughs lasting for at least three months, at least two years in a row, chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD). The term “obstructive� means that air gets trapped in the lungs, which can cause shortness of breath. With chronic bronchitis, people tend to get coughs very easily when exposed to viruses.
Conclusion Acute bronchitis is very common, especially during the winter months. It is almost always caused by a virus that is easily spread from person to person, and typically lasts two to three weeks or more. Antibiotics are not effective against the viruses that cause most cases of acute bronchitis. The usual treatments are air humidification, cough drops, and cough syrups. See a physician if there is a fever above 100.4°F that lasts longer than 24 hours, increasing or severe shortness of breath, coughing up blood, a cough that lasts longer than three to four weeks, and recurrent episodes of bronchitis. People with lowered immune systems, such as babies, pregnant women, the elderly, and those undergoing cancer or immune disease treatments, should see a doctor when they get bronchitis. To prevent acute bronchitis this winter, wash hands frequently, avoid smoking, and avoid contact with others who are coughing.
Acute bronchitis produces coughs that typically last about one to three weeks.
The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco. People with chronic bronchitis may need special medications when they get a bad cough, including inhalers, steroids such as prednisone, and sometimes an antibiotic to prevent pneumonia. Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis.
Chronic bronchitis is usually caused by an underlying history of smoking, and occurs when coughs happen frequently and recurringly. This usually requires a different treatment strategy than acute bronchitis, which may include inhalers, steroids, or antibiotics. Heather Hamernick, MD, is a board-certified family physician with Parkview Medical Clinic in New Prague, Minn. Her medical interests include urgent care, travel medicine, obstetrics, pediatrics, and evidence-based medicine.
October 2015 Survey
M I N N E S OTA H E A LT H C A R E
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 would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting.
2. I believe that the needs of the individual patient should outweigh political, social, or religious agendas in shaping policy regarding end-of-life decisions.
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4. I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives.
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5. I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues. 50% 50%
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3. I believe end-of-life legislation must guarantee that patient decisions are not influenced by any outside entity or by financial considerations.
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Minnesota Health care news November 2015
Strongly agree
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For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.
Disagree
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JOIN US.
Be heard in debates and discussions that shape the future of health care policy. There is no cost to join this informed and informative online community. Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.
www.mnhcca.org November 2015 Minnesota Health care news
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The effects of air quality from page 13
The report estimates that in 2008, about 6 to 13 percent of all residents in the Twin Cities metro area who died, and about 2 to 5 percent who visited the hospital or emergency room for heart and lung problems, did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to people’s health) made their conditions worse. The findings of the report also reiterate the fact that air pollution doesn’t affect everyone in the same way. The groups most affected by air pollution are people of color, elderly residents, children with uncontrolled asthma, and people living in poverty. Vulnerable populations may experience more health effects because these populations already have higher rates of heart and lung conditions, and they often lack the resources to deal with the added stress of air pollution. As a result, they experience more hospitalizations, emergency room visits for asthma, and death related to air pollution. In addition, minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution.
Learn more MPCA and MDH, with support from their partners, have developed a website called Be Air Aware (https://beairawaremn.org), which features data on air quality and health outcomes and showcases projects developed, funded, and implemented through Clean Air Minnesota, Minnesota’s voluntary public-private partnership on air quality. Clean Air Minnesota is a forum for leaders from business, nonprofit organizations, and government to work together to lessen the impacts of air pollution. Be Air Aware is a new resource for citizens, communities, and businesses concerned about health and air quality. The site distills and simplifies information about all major air pollutants in Minnesota—both outdoor air and indoor air. It provides valuable tips to protect individuals and families, information on current air condition and forecasts, and relevant research about air pollution. It also has some best practices and tips for business owners to consider.
Air pollution doesn’t affect everyone in the same way.
Monika Vadali, PhD, is a research scientist/risk assessor at the Minnesota Pollution Control Agency, focusing primarily on facility air emissions. She earned her doctorate in environmental health at the University of Minnesota.
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 November 2015
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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