Minnesota Health care News March 2015

March 2015 • Volume 13 Number 3

Medication and memory loss

By Susan E. Marino, PhD

Corporal punishment

By Sarah Lucken, MD

Chronic kidney disease

By Paul Olson, MD, FNKF

WHERE

NOTHING IS

IMPOSSIBLE

“

The Minnesota Autism Center has been the leader in providing quality therapy services to the autism community in this area for nearly two decades. We offer in-home, center and school-based services to families across the state of Minnesota.

“

Minnesota Autism Center has been key to unveiling a broad range of skills that have helped our son tremendously.

- Lori Walser, MAC parent

NOW WITH 8 MN LOCATIONS! LEARN MORE AT MNAUTISM.ORG

March 2015 • Volume 13 Number 3

4 7 8 10 12

14 16

News

People

Perspective Will Phillips AARP Minnesota

10 QUESTIONS Ryan Loegering, PharmD

Kidney Health

Neurology

Medication and memory loss

By Susan E. Marino, PhD

18 28

cALENDAR

The New Face of Health Care

Expanding medical professional relationships

Take Care

Long-term care costs

By LaRhae Knatterud, MPA

Lloyd’s Pharmacy, St. Paul

Public Health

Corporal punishment

By Sarah Lucken, MD

20

MINNESOTA HEALTH CARE ROUNDTABLE

Chronic kidney disease

By Paul Olson, MD, FNKF

Minnesota Healthcare Roundtable

Treating chronic illness - Is health care reform helping?

By MPP Staff

Thursday April 23, 2015, 1:00-4:00 PM Downtown Minneapolis Hilton and Towers

Background and Focus: With dramatic population growth, and as baby boomers become senior citizens, the demand for health care is exceeding the supply. Addressing the shortage of medical doctors involves creating new relationships between medical professionals. Training and licensure for Physician Assistants, Advanced Nurse Practitioners, Chiropractors, Respiratory Therapists, Physical Therapists, Home Care Providers, Dentists, and many other health care professions have become increasingly rigorous and provide expanded support to our health-care delivery system. Greater integration of these professions allows medical doctors to work to the top of their license but requires new pathways for communication and care coordination.

Objectives: We will examine many of the new partnerships that are emerging between medical doctors and other medical professionals. We will look at the ways leveraging these new relationships can improve access to care while reducing costs and improving outcomes. We will consider points of resistance to forming these kinds of health care teams and what should be avoided in creating them. We will discuss what the proper oversight for these relationships should entail and how to maximize the coordination of care that they require.

Panelists Include: • Mehul Desai, MD, Minneapolis Advanced Pain Specialists • Derek Hustvet, RRT-NPS, LRT, Director of Respiratory Service, Pediatric Home Service • John Gulon, DDS, President of Park Dental • Craig Johnson, PT, MBA, President MNPTA, Director of Clinical Integration Therapy Partners Sponsors Include: Minneapolis Advanced Pain Specialists, Park Dental, and Pediatric Home Service

Publisher Mike Starnes | mstarnes@mppub.com

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.

Editor Lisa McGowan | lmcgowan@mppub.com

Name

Associate Editor Richard Ericson | rericson@mppub.com Assistant Editor Patricia Mata | tmata@mppub.com Art Director Alice Savitski | asavitski@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com Account Executive Stacey Bush | sbush@mppub.com

Company Address City, State, ZIP Telephone/FAX Card #

Exp. Date

 Check enclosed  Bill me 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.

 Credit card (Visa, Mastercard, American Express or Discover)

Signature Email

Please mail, call in, or fax your registration by 4/20/2015 March 2015 Minnesota Health care news

3

News

Medication Can Help Smokers Quit Long Term A study from Mayo Clinic has found that taking the prescription medication varenicline (Chantix) increases the long-term success of quitting smoking for people not ready to quit, but willing to work toward quitting.

The study enrolled more than 1,500 cigarette smokers who said they were not ready to quit smoking in the next 30 days but were willing to reduce how much they smoked with a goal of quitting in the next three months. Participants were randomly selected to receive either varenicline or a placebo for six months. Their cigarette consumption was evaluated at six and 12 months. The study was published in the February issue of the Journal of the American Medical Association.

“This study is important because this opens the door to treatment for approximately 14 million smokers who have no

4

intention of quitting in the next 30 days but are willing to reduce their smoking rate while working toward a quit attempt,” said Jon Ebbert, MD, associate director for research at the Mayo Clinic Nicotine Dependence Center and lead author of the multinational study. “In the past, these smokers may not have received medication therapy, and we want them to know that different approaches are available.”

The results show that at the six-month mark, the 760 people who took varenicline were more than four times as likely to have quit smoking than the 750 who were given a placebo—32.1 percent compared to 6.9 percent. And at 12 months, those receiving varenicline were more than two times as likely to have quit—27 percent compared to 9.9 percent.

“Smokers should know that varenicline can help them quit smoking if they want to reduce their smoking prior to completely stopping,” said Ebbert.

Minnesota Health care news March 2015

Teen Pregnancy Rates Drop The rate of teen pregnancy in Hennepin County fell by 15 percent from 2012 to 2013, according to an analysis of birth certificates in Hennepin County.

A total of 597 babies were born to mothers between the ages of 15 and 19 years old in 2013, compared to 701 in 2012. Overall, the state saw a 9 percent decrease in that timeframe and the nation saw a 10 percent decrease.

need to remember that every year, more children become teens, and they need all of these supports as well. That is why potential funding declines are so concerning. Now is not the time to let our guard down.”

The data also show a 14fold difference in teen birth rates across cities, as well as significant racial and ethnic disparities.

Officials say this demonstrates a continued need for targeted resources.

According to officials, this continues a downward trend in the county that began in 2007 when 1,170 babies were born to mothers in that age range.

Hennepin County Expands E-Cigarette Ban

“To see Hennepin County’s rates fall below the state rate is especially exciting,” said Katherine Meerse, manager of the county’s teen pregnancy prevention initiative, Better Together Hennepin. “Our young people are making smart decisions, thanks to a lot of support from a range of community partners. But we

The Hennepin County Board voted six to one in early February to ban e-cigarettes everywhere smoking is currently prohibited through the Minnesota Clean Indoor Air Act, which includes workplaces, restaurants, and bars. The ban went into effect March 10.

A majority of the board felt that the ban was needed due to the lack of research on the health risks of e-cigarettes, according to Hennepin County commissioner Marion Greene, who proposed the ban.

“E-cigs are pretty untested and very much unregulated,” said Greene. “There is no way to know how much nicotine is being inhaled during use or how much nicotine somebody might be experiencing in secondhand smoke.”

Patients of Midwives Report Better Communication Researchers at the University of Minnesota School of Public Health have found that pregnant women who are assigned a provider for prenatal care during their pregnancy, versus choosing one themselves, have a better chance of receiving care from a midwife. Women who see a midwife for prenatal care report fewer communication problems than those that see other types of health care providers. According to researchers, this indicates that assigning a midwife to women with low-risk pregnancies by default could lead to better patient-clinician communication during prenatal care and childbirth.

“Good communication and informed decision-making are cornerstones of high-quality, patient-centered care,” said Katy Kozhimannil, PhD, MPA, assistant professor at the School of Public Health and lead author of the study. “In this study, we found that women who saw a midwife for pregnancy reported that they were more likely to ask questions during their visits, had a better understanding of the medical words being used, and more often felt that their care provider spent enough time with them.”

Researchers used data from the Listening to Mothers III survey, a report released in 2013 that summarizes the results of a poll of 2,400 mothers who gave birth in U.S. hospitals in 2011 and 2012.

Results of the study show that women who were assigned a prenatal care provider were 63 percent more likely to receive care from a midwife. Pregnant women who expressed a strong preference for a female provider were twice as likely to be assigned a midwife.

About 24 percent of women who received care from physicians said they held back questions because they didn’t want to be difficult and about 30 percent said they did so because they felt rushed, compared to 14 percent and 24.3 percent of women who saw midwives, respectively.

Of those who saw physicians, 47.7 percent said they were not encouraged to voice all their questions and concerns, compared to 36.7 percent of those who saw midwives. And 53.6 percent of women treated by physicians said the provider used medical terminology they did not understand, compared to 24.3 percent of those who were treated by midwives.

“Moving forward, one possibility suggested by these findings is greater use of a default midwifery option for pregnancy care for low-risk women, coupled with strong consultation and referral networks to ensure that women receive specialized care when complications arise,” said Kozhimannil. “Taken together with evidence on midwifery care’s quality and safety track record, our research implies that this kind of systems-level reform has potential to enhance communication and improve women’s birth experiences.”

Report Analyzes Minnesota’s Health System Minnesota’s health care system ranks first in the nation overall, according to Minnesota’s Health Care Performance Scorecard, a report released by the Minnesota Business Partnership (MBP).

plex m o c s is les ose the e r a ic d Me cho y l p m i s i f y ou i lt p l a n. best-bu ly, helpful peopleeapt erfect

?

friend u to th Let the tners guide yo nd budget. a ar r needs HealthP eet youDeductibles? m plan to ar e /m e di c m o c . s r tn e al t h p a r e h t i s i V

Can I keep my doctor?

Deductibles

H2462_77617 Accepted 01/19/2014. HealthPartners is a Cost plan with a Medicare contract. Enrollment in HealthPartners depends on contract renewal. ©2013 HealthPartners

3

INFORMATION

Take your leadership career in a new direction

18821 0714 ©2014 ALLINA HEALTH SYSTEM. TM - A TRADEMARK OF ALLINA HEALTH SYSTEM. EOE/AA/Vet/Disabled Employer

The new policy is more restrictive than the current state ban, which restricts e-cigarette use in government buildings, public schools, universities, day care centers, and most health care facilities.

Job Number

245-13124

Trim

Modification Date

October 22, 2014 2:33 PM

Client

HealthPartners

Bleed

Output Date

10/22/14

MN Health Care News

Live

Page #

1

Description File Name

245-13124 Medicare [Carpenter][4x5.25]_3_

SIGN-OFF [­­­­]

4” x 5.25”

Notes CD

Peter Tressel

AD

Anne Taylor

CW

Terry Thomas

AS

Mark Jenson

AM

Linda Gogolin

PM

Krista Kraabel

PA

Tera Gilmore

[­­­­] At Allina Health, we’re here to [­­­­] care, guide, inspire and comfort [­­­­] [­­­­] the millions of patients we see [­­­­] each year at our 90+ clinics, 12 [­­­­] hospitals and through a wide variety of specialty care services throughout Minnesota and western Wisconsin. We care for our employees by providing rewarding work, flexible schedules and competitive benefits in an environment where passionate people thrive and excel.

Make a difference.

Join our award-winning team.

1-800-248-4921 (toll-free) Crystal.Lester@allina.com

Apply today at allinahealth.org/careers

News to page 6 March 2015 Minnesota Health care news

5

News from page 5

The report was produced

by MBP’s Health Policy Committee, which is co-chaired by Mary Brainerd, president and CEO of HealthPartners and Mike Fiterman, chairman and CEO of Liberty Diversified International. It measures the state’s health based on 84 data points and compares it to all other states.

The results provide a framework to assess where the state’s health care system currently stands, including where the state is doing well, where improvement is needed, and how well reforms are working.

“This report confirms what many Minnesotans already believed: that our state’s health and health care system are among the nation’s finest,” said Brainerd.

“It was important to identify the strengths that Minnesota can build upon, as well as identify the gaps and opportunities for improvement.”

States were ranked on five dimensions of performance. Minnesota ranked first for coverage and access and has one of the lowest rates of uninsured in the U.S. It ranked second for population health, performing very well across most quality and outcome measures available, according to the authors. It had fewer residents report “fair” or “poor” health than any other state.

Minnesota ranked fourth for health care delivery, and fifth for status of health care reform efforts. However, the authors state that Minnesota compared very well on specific measures of system reform, including the adoption of health information technology, reporting, and transparency. Minnesota did less well on status of health care cost, ranking 22nd in the nation.

The authors concluded the report with six recommendations for how the state and business community should partner to improve Minnesota’s health care system and ensure the changes

being made address the state’s most critical needs.

“Health care is in a period of transition and it is imperative that we know what we are doing and what we can improve upon,” said Fiterman. “This report will help Minnesota pinpoint reform to address our state’s most pressing needs.”

Nursing Homes Get Quality Improvement Funds Minnesota nursing homes will receive an additional $17 million over the next one to three years through the Minnesota Department of Human Services’ (DHS) Performance-based Incentive Payment Program (PIPP) that rewards quality improvement projects.

Through the program, nursing homes can contract with DHS to earn higher medical assistance payments of up to 5 percent of

the operating payment rate.

“Minnesota’s nursing homes provide essential care for our parents, grandparents, and loved ones,” said Gov. Mark Dayton.

“I thank these providers for the efforts they are undertaking to ensure all their residents receive the best possible care.”

Projects at 95 nursing homes in Minnesota have been approved to receive funding through the program. Empira Collaborative facilities were awarded the highest amount, with a total of $10.9 million. The funds will be used for projects to reduce sundown syndrome, which affects people with dementia and other cognitive impairments, at several Empira locations across the state.

“PIPP projects designed by the nursing homes themselves have been shown to improve quality not just in targeted areas, such as falls prevention and resident mental health, but to improve nursing home quality overall,” said Lucinda Jesson, DHS commissioner.

Choose well New choices in health care are here. Introducing UCare ChoicesSM, affordable new health plans from a leader in Minnesota health care, with coverage for young adults, families, empty nesters and everyone in between.

Find out more at UCareChoices.org, and look for us on the MNsure health insurance marketplace and choose UCare Choices.

6

UC610_UCare_Choices_HCN_Ad_8.5x5.25.indd 2

Minnesota Health care news March 2015

9/23/14 4:46 PM

People

Jennifer Gerckens, MD, board-certified in physical medicine and rehabilitation (PMR), has joined the PMR department at Hennepin County Medical Center, Minneapolis. She completed medical school and a residency in PMR at Ohio State University Medical Center, Columbus.

Jennifer Gerckens, MD

Ronald Ronquist, MD, board-certified in orthopedic surgery, has joined the Essentia Health– Virginia Clinic. Ronquist earned a medical degree from the University of Michigan Medical School in Ann Arbor, and completed a residency in orthopedic surgery at McLaren Health Care–Flint in Flint, Mich.

Riddell W. Scott, MD, board-certified in dermatology, has joined Ridgeview Specialty Ronald Ronquist, Clinic. She graduated from the MD University of Tennessee Health Sciences Center College of Medicine in Memphis, where she completed a residency in dermatology.

Charles J. Snow, MD, board-certified in obstetrics and gynecology, has joined Western OB/GYN in Waconia and Chaska, a division of Ridgeview clinics. Snow graduated from the F. Edward Hébert School of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Md., and served a residency in obstetrics and gynecology at the University of Minnesota Medical School.

Riddell W. Scott, MD

Penny Wheeler, MD, has assumed her position as CEO of Allina Health, succeeding former CEO Kenneth H. Paulus, who retired at the end of 2014.

Previously, Wheeler served as Allina’s president and chief clinical officer, having joined the Allina Health executive leadership team in June 2006.

Wheeler, an obstetrician-gynecologist, completed medical school, residency, and an obstetrics and gynecology fellowship at the University of MinnePenny Wheeler, sota Medical School.

MD

Chester B. Whitley, PhD, MD

SunButter is ®

Charles J. Snow, MD

Chester B. Whitley, PhD, MD, director, PKU Clinic, Departments of Pediatrics and Experimental and Clinical Pharmacology at the University of Minnesota, has been named a 2014 RARE Champion of Hope–Medical Caregiver by Global Genes.

Global Genes is a California-based nonprofit organization that advocates for patients with rare diseases, and honored Whitley for his work with PKU patients. Whitley is board-certified in genetics and completed all his medical training at the University of Minnesota.

Pe a n u t Fr e e FOR ME! SUNFLOWER SPREAD FREE ALLERGY KITS! • Product Samples • Stickers to ID kids’ lunches • Coloring book • Coupons info@sunbutter.com 877-873-4501

SunButter.com March 2015 Minnesota Health care news

7

Perspective

Caring for caregivers Our next big challenge

T

here are more than 670,000 unpaid family caregivers in Minnesota. These are family members, friends, and neighbors who are providing care for no charge, often while working a full-time job.

The services these unsung heroes provide not only help their loved ones live independently in their homes and communities, they also help the state save money.

Each year, family caregivers in Minnesota provide more than $8.5 billion in services—services that don’t have to be paid for by the state or health care system.

Will Phillips AARP Minnesota Mr. Phillips is the state director of AARP Minnesota, the state affiliate of the national Association for the Advancement of Retired Persons, an organization working on behalf of older adults nationwide. Phillips has worked with AARP in various capacities for more than nine years. To learn more about what AARP MN does, please visit www.aarp.org/states/ mn.html/ or call (866) 554-5381.

Free, but costly However, just because this care isn’t paid for doesn’t mean it comes without a cost. The sacrifices caregivers make often have a negative impact on their income, retirement security, and mental and physical well-being. As a state we can and should be doing more to support them.

Minnesota can and should be passing bipartisan health care solutions like the CARE Act. After all, when it comes to health care we’re the best.

We have some of the best hospitals and clinics in the nation, dedicated doctors and nurses, affordable health plans, and the top-rated long-term care system in the nation, according to AARP and the Scan Foundation.

We need to put the same emphasis on supporting caregivers as we do on supporting patients, because caregivers are patients too. The physical and mental toll of illness and disease has a direct impact on caregivers, which is why we need to elevate them to be an official part of the process and health care team.

Hospital discharges aren’t always orderly affairs.

One setting in which caregivers typically need more support is at the hospital. When a loved one enters the hospital it is a stressful and confusing time for the family, especially if the patient was hospitalized suddenly.

Things can get worse for caregivers when it is time for the patient to come home. Hospital discharges aren’t always orderly affairs and all too often, caregivers aren’t given enough advanced notice or training to adequately take care of their loved ones. According to a recent AARP Caregiving report, almost half of family caregivers perform medical or nursing tasks for loved ones and most report that they received little or no training to perform these tasks.

Legislative initiative To help close this gap, AARP will introduce the Caregiver Advise, Record, Enable (CARE) Act to the state Legislature in 2015. This bill is designed to help ensure that family caregivers have access to better information and training. The CARE Act will require: • That the name of the family caregiver is recorded when a loved one is admitted into a hospital; • That the family caregiver is notified if the loved one is to be discharged to another facility or back home; and,

8

• That the facility must provide an explanation and in-person instruction of the medical tasks that the family caregiver will perform at home, such as medication management, injections, and wound care.

Minnesota Health care news March 2015

Some hospitals and clinics are already doing this and should be commended for it. However, when it comes to empowering, training, and supporting caregivers, it is the state’s responsibility to make sure that no one falls through the cracks.

Investing in the future Passing the CARE Act is not just about better serving today’s caregivers, it is about investing in the future of our state.

We know Minnesota is getting older. We know tomorrow’s seniors want to stay in their home communities and we know it is much more cost-effective to care for them there. We also know that in order to do so, we’re going to need more dedicated, unpaid family caregivers. Those caregivers should be empowered and have access to the training they need to keep their loved ones healthy and help them age with dignity and independence.

Alcohol is more harmful to an unborn baby than cocaine, marijuana or heroin.

Drinking during pregnancy can cause Fetal Alcohol Spectrum Disorders (FASD) which permanently harm the way your baby learns and behaves.

- ZERO ALCOHOL FOR NINE MONTHS.

10 Questions

Customizing medical care Ryan Loegering, PharmD Dr. Loegering is a compounding pharmacist at Lloyd’s Pharmacy, St. Paul.

What does a compounding pharmacist do?

Compounding gets back to the roots of pharmacy, because pharmacists originally compounded every prescription based upon a physician’s order. In other words, every prescription was made individually. Over time, pharmaceutical manufacturing assumed that role and pharmacists shifted toward a dispensing role. Compounding remains an important tool, in part because it can increase patient compliance with medication: A medication that a patient won’t or can’t take doesn’t work.

Compounding pharmacists use many published resources and information from the Professional Compounding Centers of America (PCCA) to troubleshoot problems preventing patients from using commercially available medication.

What are some of the most common prescriptions you fill by compounding? Some of the most common prescriptions involve hormone replacement for people going through menopause (women) or andropause (men). Other common prescriptions include: •T opical pain medications—i.e., those that can be applied directly to the affected area— that are formulated to be non-narcotic as an alternative to oral opiate-narcotic medication that could have a narcotic effect on the patient’s entire body. iquid suspensions for patients who have difficulty swallowing •L tablets.

•V eterinary prescriptions for which an appropriate commercially available product is unavailable. These could include creams, suspensions, capsules, or even medication masked as a flavored treat.

Please give some reasons you are asked to prepare compounded medication. Have you ever wished your child’s medicine tasted better, so they would accept it without fussing?

Or struggled to cut a prescription tablet in half because it wasn’t manufactured in the strength you required? Perhaps a patient could benefit from having multiple medications combined into a single dose. For patients allergic to certain dyes, we compound medication into dye-free formulations. An additional benefit of compounding medications for patients occurs when production of commercially available medication is disrupted. Rather than a patient discontinu-

10

Min n esota Health care n ews March 2015

ing or changing medication, his or her physician may ask the pharmacy to compound a product containing the same active ingredient as the unavailable medication.

A patient may benefit greatly from using the services you provide but be unaware they exist.

How do people find out you can help them? Prescription compounding is a rapidly growing component of many physicians’ practices, but people may not realize the extent of compounding’s resurgence in recent years due to today’s aggressive marketing by drug manufacturers.

A patient can ask his or her health care practitioner about compounding; patient, prescriber, and pharmacist can work together to solve unique medical problems. Patients also can contact a compounding pharmacy. To find the closest one, visit www.pccarx.com/contact-us/find-a-compounder What are some of the insurance coverage issues around compounded pharmacy? Insurance plans vary widely regarding whether or not they will cover compounded medications.

Some plans will review such a prescription via a prior authorization process to determine eligibility. We attempt to bill and work with insurance companies to have compounded medication covered.

When insurance plans deny coverage, some patients elect to pay out of pocket. The cost depends on factors such as the ingredients and equipment required, plus the time the pharmacist spends researching and preparing the medication.

What are some kinds of medications that cannot be created by a compounding pharmacist? The ability to compound a specific medication or dosage form is evaluated on a case-by-case basis. Medications that have been pulled off the market for safety concerns should not be compounded. Biologically derived medications, such as monoclonal antibodies, also are not appropriate for compounding. The ability to compound a medication is determined by availability of ingredients. If pharmaceutical suppliers lack pure ingredients needed for an item, we cannot compound that item. Many questions need to be addressed when determining if something can be compounded, including how long the patient needs to use the medication and whether the medication will be stable for the duration of use.

Compounding pharmacists provide medication to veterinarians as well as to physicians and dentists. What do you need to know about how these two groups of patients metabolize medications? Many people treat their pets as their own children but when it comes to medications, pets are not little people! The liver and kidneys are responsible for metabolizing and clearing medications from the body, and the liver contains enzymes that break down the medication. Pets don’t necessarily have the same enzymes or in the same concentrations as humans. For example, humans commonly use acetaminophen (Tylenol), but that drug is toxic to cats because their livers can’t break it down. The PCCA, as well as certain pharmaceutical suppliers, conduct training and continuing education programs for pharmacists to keep us up to date on human and veterinary compounding.

manufacturer, making very large amounts of medication and sending it to clinics for use with patients NECC knew nothing about. As the scale of production increases, the potential for problems increases. A compounded item should be created as a result of a direct order from the prescriber for a specific patient.

Safety of compounded medication is a joint effort among practitioners, pharmacists, state Boards of Pharmacy, and the FDA.

Prescription compounding is... rapidly growing.

What can you tell us about public perception of the safety of compounding pharmacies? Compounding has been under much more scrutiny the last few years. In September 2012, a Massachusetts company, New England Compounding Center (NECC), shipped more than 17,000 vials of an injectable steroid solution to heath care facilities in 23 states. Many of the vials were contaminated and resulted in many people becoming ill. Tragically, more than 50 patients died from complications. NECC has since been permanently closed. This tragedy prompted the Food and Drug Administration (FDA) and state Boards of Pharmacy to examine who should have ultimate oversight over compounding. NECC functioned in a gray area: It was licensed as a pharmacy but operated as a

What are some of the issues a compounding pharmacist faces in making injectable medication? Compounding injectable medication requires much more validation, and certification of equipment and processes. This is because when a medication is injected, it bypasses the body’s natural defenses against infection.

Therefore, injectable products must be sterile. Sterile products need to be prepared in a sterile environment using sterile technique. This requires a specialized preparation room and specialized equipment i.e., a so-called “clean room” and/or sterile glove boxes. Then, once the product is finished, a sample of it needs further analysis to ensure that no microbes, fungus, or pyrogens (anything that could cause a fever) were introduced during production.

What do you see as compounding pharmacy’s future?

The demand for pharmacists has increased as the baby boomer generation reaches retirement. Pharmacy schools across the nation, including the University of Minnesota, have expanded their enrollment in anticipation of increased demand. Compounding faces regulatory and insurance reimbursement obstacles. However, I believe it will continue to fill a very important need by customizing medical care.

Call 1-800-333-HOPE Before you lose what really matters

Gambling problems can only be solved if you have the conversation. Reach out and ask for help before you lose what is really important.

GetGamblingHelp.com March 2015 Min n esota Health care n ews

11

Public Health

Corporal

punishment Outdated, ineffective, and harmful

By Sarah Lucken, MD

L

ast fall, maltreatment of two local 4-year-olds made national news. Eric Dean died at the hands of his stepmother and the son of Adrian Peterson was whipped by his father. In reaction to the first incident, Gov. Dayton formed a task force to strengthen Minnesota’s child protection system and better address suspected cases of child maltreatment.

Reaction to the Peterson case has been more problematic. Few physicians have difficulty identifying that the whipping Adrian

a t ! i t s t ! i i e t s VVi rass M k e r k a r a M e r e m r m FFaar Locally grown foods:    

are fresh and tasty are a healthy choice offer a variety of food support your local economy

Minnesota Diabetes & Heart Health Collaborative

Visit Minnesota Grown at www.minnesotagrown.com for a list of over 950 farmers markets, orchards and berry farms.

The Minnesota Diabetes and Heart Health Collaborative: Working together to keep you informed www.mn-dc.org

12

Minnesota Health care news March 2015

Peterson’s son suffered crossed the line from corporal punishment to child abuse due to the degree of injuries sustained, whether intended or not. But the case reignited debate about whether corporal punishment to discipline children is ever appropriate.

What constitutes corporal punishment?

Corporal punishment is the use of physical force to cause pain to a child as a means of punishing them and modifying his or her behav-

ior. It includes slapping, smacking, whipping, and spanking, but may also include other ways of causing a child physical discomfort such as standing in painful positions or washing a child’s mouth with soap. It does not include physical restraint to keep children safe from pain or harm, such as holding them back from running into a street or stopping them from hitting other children.

Evidence-based advice The “Report on Physical Punishment in the United States: What Research Tells Us About Its Effects on Children” has been endorsed by many organizations, including the American Academy of Pediatrics and the American Medical Association. This report, published in 2008 by the then Ohio-based Center for Effective Discipline, reviewed research from hundreds of studies done by a wide range of professionals about the effects of corporal punishment on children.

Corporal punishment is the use of physical force to cause pain to a child.

In my work as a pediatrician at a large, urban hospital, kids frequently misbehave in the exam room, offering me many opportunities to see different parental disciplinary methods in action.

Most troubling is when a parent hits a child. I can’t help wondering: If a parent hits a child in front of me, what happens at home?

Among the report’s conclusions: Physical punishment does not improve children’s behavior in the long run. Instead, it makes them more aggressive.

Who does it?

Counseling parents not to spank or hit children is difficult since so many parents do it. As many as two-thirds of parents of young children report using physical punishment; about 70 percent of U.S. adults approve of corporal punishment. Parents use corporal punishment because they believe it works to correct misbehavior, it’s how they themselves were disciplined as children, or their culture or religion sanctions it. Many don’t see anything wrong with it.

Research also shows that physical punishment puts children at risk for other negative outcomes, including mental health problems such as anxiety and depression, alcohol and drug use, poorer parent-child relationships, and an increased risk of serious injury and physical abuse. Children who are physically punished are seven times more likely to be severely assaulted. Children who are physically punished are also more likely to be violent with their own partners and children once they’re adults.

In this country, physical punishment of children is still permitted by law. In this we are out of step with many countries where hitting children is viewed increasingly as a human rights violation.

Twenty-three countries have banned physical punishment in all settings, including the home. More than 100 have banned it in schools.

The Parliamentary Assembly of the Council of Europe (45 member countries) stated in 2005:

Corporal punishment to page 32

“The Assembly considers that any corporal punishment of children is in breach of their fundamental right to human dignity and physical integrity . . . Striking a human being is prohibited in European society and children are human beings. The social and legal acceptance of corporal punishment of children must be ended.”

In 1989, the U.S. helped draft the United Nations Convention on the Rights of the Child. Unfortunately, of the 193 U.N. member nations, only the U.S., Somalia, and South Sudan have failed to ratify it.

Approval declines Despite this lack of legal progress, approval of corporal punishment in this country has been declining. In the 1960s, 94 percent of adults were in favor of it. By 1986 that number had dropped to 84 percent and in 2004, fewer yet, at 71.3 percent. Seventy-seven percent of Americans now disapprove of school physical punishment. Twenty-nine states, including Minnesota, prohibit all physical punishment in public schools. Minnesota is also one of just three states that have outlawed physical punishment in all five settings that care for children: schools, juvenile detention facilities, child care centers, foster care, and residential care.

While attitudes are evolving, we physicians want to provide parents with evidence-based advice. Does corporal punishment as a disciplinary method work? Does it cause long-term harm? Does it often escalate to child maltreatment? Here are answers.

GOUT–3clr Although corporal punishment may deter bad 210 behavior 041 in the short term it actually increases disobedience and aggressiveness 01.14.15 over time. The article “Mothers’ Spanking of 3-Year-Old Children

Do you experience occasional flare-ups of

Gout?

Radiant Research is conducting a clinical research study of an investigational medication for Gout.

Qualified participants will receive all study-related care and investigational medication at no charge and may be compensated for time and travel. Call the number below to see if you may qualify.

Call Mon-Fri for more information

952.848.2065

7700 France Ave., Suite 100, Edina, MN www.radiantresearch.com

We Can’t Do It Without YOU!

March 2015 Minnesota Health care news

13

• Ads may be used for newspapers, fliers, posters, mailings, public transportation, or outdoor advertising.

• Ad may appear white on black or black on white or color.

Kidney health

Chronic kidney disease Habits that damage kidneys

By Paul Olson, MD, FNKF

M Telephone Equipment Distribution (TED) Program

ost people know that a major function of the kidneys is to remove waste products and excess fluid from the body, but not many people know that the kidneys are critical to the regulation of additional bodily functions. For exam-

That’s why the kidneys, each about the size of a fist, are so important to overall health. The kidneys perform their life-sustaining job nonstop, filtering about 200 quarts of fluid every 24 hours.

Do you have trouble using the telephone due to hearing loss, speech or physical disability?

If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify.

Please contact us, or have your patients call directly, for more information.

1-800-657-3663 www.tedprogram.org Duluth • Mankato • Metro Moorhead • St. Cloud

The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services

14

ple, a hormone produced by the kidneys stimulates red blood cell production. Other hormones produced by the kidneys help regulate blood pressure. Still others control calcium metabolism, which, in turn, affects bone strength.

Minnesota Health care news March 2015

Over time, a variety of health and lifestyle factors can damage the kidneys, leading to a condition known as chronic kidney disease (CKD). CKD is defined as having a marker of kidney abnormality, such as protein in the urine, and having decreased kidney function for three months or longer.

Most Americans with CKD don’t know they have it.

Unfortunately, most of the more than 26 million Americans with CKD don’t know they have it. That’s because symptoms are usually silent until the disease’s late stages. By that time, CKD may have produced irreparable damage. Consequently, prevention and early detection of this condition are the keys to keeping CKD from progressing to kidney failure.

Causes • Diabetes is a disease in which the body does not make enough insulin or cannot use normal amounts of insulin properly. This results in a high blood sugar level, which can cause blindness and many other problems throughout the body. Diabetes is the leading cause of kidney disease.

• High blood pressure (also known as hypertension) is another common cause of kidney disease, as well as heart attacks and strokes. High blood pressure occurs when the force of

blood against an artery’s walls increases. When high blood pressure is controlled, the risk of complications such as chronic kidney disease is decreased.

• Glomerulonephritis is a disease that causes inflammation of the kidney’s tiny filtering units.

Glomerulonephritis can begin suddenly after a strep throat, and then stop without progressing to kidney failure. The disease also can develop slowly over the course of several years, and cause progressive loss of kidney function.

1. Using painkillers for a long period of time. Long-term use of certain pain medications, especially at high doses, can harm kidney tissue and reduce blood flow to the kidneys. This includes over-the-counter and prescription pain medications, with nonsteroidal anti-inflammatory drugs (NSAIDs) the main culprits. Common NSAIDS include aspirin, ibuprofen (such as Advil and Motrin), and Celebrex. As many as 1 percent to 3 percent of new cases of chronic kidney failure each year may be caused by overuse of pain medication.

Two simple blood tests can detect markers of kidney disease early.

• Polycystic kidney disease is the most common inherited kidney disease. It is characterized by the formation of kidney cysts that enlarge over time and may cause serious kidney damage and even kidney failure. Other inherited diseases that affect the kidneys include Alport syndrome, characterized by glomerulonephritis that leads to kidney failure, as well as hearing loss and the potential for certain eye problems such as cataracts; and cystinuria, an inherited tendency to form kidney stones.

2. Smoking cigarettes. The effects of smoking on the lungs and heart are well publicized, but studies also show that people who smoke are more likely to have protein in the urine. Diseases that affect the kidneys, such as diabetes and high blood pressure, are also exacerbated by smoking. As a result, smokers are more likely than nonsmokers to need dialysis or kidney transplants.

3. Eating and drinking lots of sugar. It’s probably pretty obvious that a morning doughnut or a candy bowl on your desk is loaded Chronic kidney disease to page 34

Detection There are two simple blood tests that can detect markers of kidney disease early, so that a physician can begin treatment to prevent progression to CKD and kidney failure: • A test for blood creatinine. Creatinine is a waste product of metabolism. Normally, the kidneys maintain the level of it in the blood within a stable range. An elevated creatinine level indicates that the kidneys are not functioning properly.

stdavidscenter.org 952.548.8700

• A test for protein in the urine. The albumin-to-creatinine ratio (ACR) estimates the amount of albumin, a type of protein, in the urine. Excess albumin may mean that the kidney’s filtering units have been damaged by disease. Since the ACR can be temporarily elevated by fever or strenuous exercise, a doctor will perform this test for several weeks before deciding whether it represents kidney disease.

It is especially important that people at increased risk for chronic kidney disease have these two tests conducted annually.

Those at increased risk include anyone with diabetes, high blood pressure, age over 60, and those with a family history of kidney failure. Also at increased risk of developing kidney disease are African Americans, Hispanics, Asians, Pacific Islanders, and Native Americans.

Habits worth changing Whether or not someone is at risk for kidney disease, there are a number of everyday behaviors that could damage the kidneys. This damage is often irreversible, so take note of these five common ways you may be harming your kidneys without knowing it:

YOU

belong HERE.

Early Childhood Education • Autism Services Pediatric Speech, Music and Occupational Therapy Children’s Mental Health • Foster Care Services for Individuals with Lifelong Special Needs More than 2,400 families have found a place to belong at St. David’s Center.

FIND YOUR PLACE.

March 2015 Minnesota Health care news

15

Neurology

Medication and memory loss It’s not necessarily dementia

By Susan E. Marino, PhD

W

ho among us, on occasion, hasn’t struggled to remember, “What did I do with those keys?” or, “What was her name?” When these and other episodes of forgetfulness occur with increasing frequency, we often assume that age is getting the better of us. And if memory loss begins to significantly interfere with our functioning or that of our loved ones, thoughts quickly and fearfully may turn to Alzheimer’s disease or other dementia as the likely culprit.

p U e Wak aking without w er! n your par t

TCL Vibe

™

The Vibe is less than 3” big but has huge features for such a small alarm clock! The wireless wristband vibrates when your alarm goes off, gently waking you up. A loud, audible alarm can be set to wake your partner at a later time.

Learn More: www.harriscomm.com/HCN-VIBE Request a FREE Catalog www.harriscomm.com (800) 825-6758

Visit our showroom! 15155 Technology Dr, Eden Prairie, MN 55344

16

Minnesota Health care news march 2015

Although aging, illness, stress, and fatigue certainly can undermine our ability to fluently recall words, faces, and places, when seeking reasons for our lapses we should look in the medicine cabinet first. It might contain one or more commonly prescribed drugs that are known to cause memory problems in some people when taken alone or in combination with other medication.

Who is at risk?

According to a report from the Centers for Disease Control and Prevention (CDC) entitled “Health, United States, 2013,” from 2007–2010, nearly 50 percent of Americans reported taking one or more prescription drugs in the past 30 days. Given our increasing reliance on pharmaceuticals, there’s a good chance that at least one among the list of memory-impairing drugs is on the shelf.

Polypharmacy, which refers to using more than one prescribed medicine, is particularly common among the elderly. People in this population are more likely to be taking multiple medications on a daily basis, which increases the chance of producing drug-induced memory impairment. In fact, the same 2013 CDC report stated that the percentage of people “taking five or more drugs in the past 30 days increased with age, from less than 1.0 percent of children to 39.7 percent of adults aged 65 and over.” Moreover, because of age-related changes in how drugs are handled by the body, the elderly are more vulnerable to medications that can potentially interfere with memory.

Medications do not affect everyone equally.

Top 10 culprits Which drugs are most likely to be associated with memory loss?

(Caveat: The following medications do not affect everyone equally, and you should never stop taking these or other medications without first consulting your health care provider.)

1.

Benzodiazepines Common examples: Alprazolam (Xanax), clonazepam (Klono-

pin), diazepam (Valium), flurazepam (Dalmane), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion).

Benzodiazepines are used to treat a broad spectrum of anxiety disorders, agitation, delirium, and muscle spasms.

They also are effective in the treatment of insomnia, nausea (lorazepam), and seizures.

2.

Sleep aids Common examples: Eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien).

The nonbenzodiazepine sedative-hypnotics, used to treat insomnia and sleep problems, are among the most widely prescribed medications. It’s important to note that this class of drugs has been known to make someone not remember their behavior while using the medication.

3.

Statins Common examples: Atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).

Statins are effective in reducing elevated cholesterol in patients who have risk factors for heart disease. Their long-term use has been associated with cognitive and memory problems.

TCAs preceded the newer generation of antidepressants, known as serotonin reuptake inhibitors, or SRIs. Although TCAs are more likely to produce problems with memory and other cognitive problems than are SRIs, they still are prescribed for depression. They increasingly are prescribed for anxiety disorders, eating disorders, obsessive-compulsive disorder, chronic pain, and smoking cessation.

6.

Opioid analgesics Common examples: Fentanyl (Duragesic), hydrocodone (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), morphine (Astramorph, Avinza), and oxycodone (OxyContin, Percocet).

Opioid analgesics are narcotic painkillers used to help relieve moderate to severe chronic pain that can result from a wide variety of causes. They are highly addictive.

7.

Beta-blockers Common examples: Atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and timolol (Timoptic).

Beta-blockers slow heart rate, and are used in the treatment of high blood pressure, congestive heart failure, and abnormal heart rhythms. They also are prescribed for migraines, glaucoma, and to reduce tremors.

Medication and memory loss to page 19

is n o i t s e l qu a e r e h T ke a m n a who c e e asier? r M edic althPartners Freedeocmt palnadn to

4.

Antiepilepsy drugs (AEDs) Common examples: phenytoin (Dilantin), carbamazepine (Tegretol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), rufinamide (Banzel), valproic acid (Depakote), topiramate (Topamax), zonisamide (Zonegran), and ezogabine (Potiga).

Hea perf Turn to p you find the get. d el let us h needs and bu ur meet yo

Originally indicated for use in controlling and preventing seizures in patients with epilepsy, many AEDs increasingly are being prescribed for migraine prevention, pain, bipolar disorder, and other mood disorders. As with medications from other drug classes, the newer generation of AEDs, such as lamotrigine, gabapentin, and levetiracetam have fewer effects on cognition than first-generation AEDs such as phenytoin and carbamazepine. An exception to this is topiramate, which at higher doses significantly impairs thinking and memory.

V i si t h e

al t h p

.c om / ar t n e r s

m e di c a

re

5.

Tricyclic antidepressants (TCAs) Common examples: Amitriptyline (Elavil), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil).

H2462_72596_01 Accepted 9/25/2013. HealthPartners is a Cost plan with a Medicare contract. Enrollment in HealthPartners depends on contract renewal. Š2013 HealthPartners

1

INFORMATION

Trim 4"w x 5.25"h Modification Datecare February 20,news 2014 2:30 PM march 2015 Minnesota Health

Job Number

245-13124

Client

HealthPartners

Description

Medicare 2014 Print

File Name

245-13124 Medicare [Home][4x5.25] r1

SIGN-OFF

Bleed

Output Date

02/20/14

Live

Page #

1

Notes

17

Calendar Mar. 16

American Diabetes Association Alert Day

Community Conversation on Mental Health

The Roseville Human Rights Commission is hosting this free session to encourage discussion about mental health and mental illness, address myths and misinformation, and increase community knowledge and support. There will be a presentation followed by a group discussion.

To register, call (651) 645-2948.

On March 24, the American Diabetes Association organizes Alert Day, a “wake-up call” asking the American public to take a short test to determine their risk for developing type 2 diabetes.

According to the Centers for Disease Control and Prevention, 25.8 million Americans live with diabetes. Type 2 diabetes accounts for 90 percent to 95 percent of these cases. It is usually associated with older age, obesity, and family history of the disease. Type 2 diabetes can lead to other medical issues such as heart disease, stroke, nerve damage, and kidney or eye problems if not managed well.

Monday, March 16, 6:30–8:30 p.m., Roseville Skating Center–Fireside Room, 2661 Civic Center Dr., Roseville

Mar. 26

Medicare 101

UCare offers this free informational session about Medicare. Come learn the basics of what Medicare is, if you are eligible, and what your options are. For more information or to reserve your spot, call (877) 523-1518. Please arrive five to 10 minutes early.

Type 2 diabetes can be prevented by developing healthy eating habits, being physically active, and maintaining a healthy weight. These activities also can help manage diabetes, along with medications if needed.

Thursday, March 26, 5:30–6:30 p.m., HealthEast–Woodwinds Health Campus, 1925 Woodwinds Dr., Woodbury

Apr. 13

Fitness for People with Lupus or Arthritis

To take the American Diabetes Association’s Diabetes Risk Test, visit www.diabetes.org/are-you-at-risk/ diabetes-risk-test

Lupus Foundation of Minnesota hosts free exercise sessions designed to help people living with lupus and other chronic conditions reduce joint pain, increase energy levels, and regain freedom of movement while exercising.

Call Sandy at (952) 746-5151 to register by April 10.

Apr. 14

Monday, April 13, 12–1 p.m., Fogerty Arena, 9250 Lincoln St. N.E., Blaine

Hennepin County Medical Center offers this support group for adults living with diabetes. Join others with this condition for support, education, and guidance. Call Linda at (612) 873-6963 for more information or to sign up.

Apr. 14

After Treatment: Is What I Am Feeling Normal?

Park Nicollet hosts this free information session for patients who are nearing the end of, or have already finished, cancer treatment. Come discuss the common emotional ups and downs many experience at this stage, as well as strategies to anticipate and manage these feelings. Significant others, family members, and caregivers welcome. Preregistration required.

Call (952) 993-5700.

Tuesday, April 14, 3–4:30 p.m., Park Nicollet Frauenshuh Cancer Center, Carlson Community Room–Ground Floor, 3931 Louisiana Ave. S., St. Louis Park

18

Diabetes Support Group

Tuesday, April 14, 10–11:30 a.m., Hennepin County Medical Center, 900 8th St. S., Shapiro Building, Rm. S1.300, Minneapolis

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Fax submissions to (612) 728-8601 or email them to amarlow@mppub.com. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.

Minnesota Health care news March 2015

Apr. 16

Better Breathers Club

American Lung Association in Minnesota hosts these free monthly meetings for people living with chronic lung disease.

Come meet others facing similar issues and learn ways to better cope with your illness.

No registration required. Call (651) 223-9565 for more information.

Thursday, April 16, 1–3 p.m., Lutheran Church of the Good Shepherd, 4801 France Ave. S., Minneapolis

Apr. 16

Bladder Cancer Support Group

Fairview Health Services offers this support meeting for bladder cancer survivors, caregivers, family, friends, and supporters. Join others on a similar journey for support and education. Registration required. Call (612) 672-7272 to RSVP. Thursday, April 16, 6–8 p.m., The Richard M. Schulze Family American Cancer Society Hope Lodge, 2500 University Ave. S.E., Minneapolis

Apr. 22

Newly Diagnosed with Breast Cancer Program

Allina Health hosts this free support program for women who have been diagnosed with breast cancer within the last four months.

Join the group sessions for support and education as you adapt to your diagnosis and begin treatment. Facilitated by a licensed psychologist and registered nurse.

Call (612) 863-4458 to RSVP. Wednesday, April 22, 11 a.m.–12:30 p.m., Abbott Northwestern Hospital, Piper Cancer Institute, 4th Flr., 913 E. 26th St., Minneapolis

Apr. 28

Parents of Kids with Epilepsy

The Epilepsy Foundation of Minnesota hosts this discussion group for parents of children living with epilepsy. This month’s topic is how to talk with your child’s physician about their condition. A physician from Children’s Hospitals and Clinics will join the group to provide insights and answer questions.

Call (651) 287-2310 to RSVP. Tuesday, April 28, 6:30–8 p.m., Epilepsy Foundation of Minnesota, 1600 University Ave. W., St. Paul

Medication and memory loss from page 17

histamines are not well tolerated by older patients. Newer antihistamines, such as loratadine (Claritin) and cetirizine (Zyrtec), are less likely to pose a risk to memory.

8.

Urinary incontinence drugs (anticholinergics) Common examples: Darifenacin (Enablex), oxybutynin (Ditropan XL, Gelnique, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), and trospium (Sanctura).

10.

Prescribed to relieve an overactive bladder and reduce incontinence, or the sudden urge to urinate, medications in this drug class can have a pronounced effect on memory. This is especially true in the elderly and when taken with other anticholinergics.

However, darifenacin is the least likely of these drugs to cause memory problems.

9.

Antihistamines (first-generation) Common examples: Brompheniramine (Dimetane), carbinoxamine (Clistin), chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), diphenhydramine (Benadryl), and hydroxyzine (Vistaril).

These drugs are best known for their use to prevent or relieve allergy and cold symptoms such as itchy eyes and stuffy nose, or to counteract severe allergic reactions. Sometimes they are prescribed for insomnia, anxiety, or to prevent motion sickness. Unfortunately, these first-generation anti-

BILATERAL KNEE REPLACEMENT HELPS FARMER GET HIS

Dopamine agonists (antiparkinsonian drugs) Common examples: Apomorphine (Apokyn), pramipexole (Mirapex), and ropinirole (Requip).

These drugs often are used to treat Parkinson’s disease, certain types of pituitary tumors, and some cases of restless legs syndrome (RLS).

Check your medications Although there are many things that can make it difficult to recall information, failing memory need not be accepted as an inevitable part of aging. So before you chalk those missing car keys up to getting older, check your medications. Alert your health care provider if you notice a decline in your memory or your loved ones’ memory after starting to take a new medication, and never stop taking medication without first consulting your health care provider.

Susan E. Marino, PhD, is the director of the Center for Clinical and Cognitive Neuropharmacology, and an assistant professor in experimental and clinical pharmacology, at the University of Minnesota.

Tim Jackson has been a dairyman most of his life. As the years passed, his knees wore out. “Two years ago they were getting so bad that I could hardly navigate anymore,” said Tim. He began to get depressed because it was too painful to continue his work and enjoy an active lifestyle. Tim sought help from providers and had some treatment before finding St. Croix Orthopaedics (SCO). His treatment journey with SCO helped him find the solution he was looking for. “It was a positive experience from the beginning,” said Tim. “He (the surgeon) painted a whole other picture for my life.”

Watch Tim’s story online. Go to http://bit.ly/183Vlpc Appointments: Online or call 651-439-8807 | Multiple clinics in Minnesota and Wisconsin

www.stcroixortho.com

march 2015 Minnesota Health care news

19

Minnesota health care roundtable

About the Roundtable

Mr. Starnes: According to the Centers for Disease Control and Prevention, as of 2012, about half of all American adults—over 117 million people—had at least one chronic illness. Seven of 10 deaths result from chronic illness, and 84 percent of all health care costs relate to chronic illness. With numbers like these, an important part of health care reform involves how we treat chronic illness. Today, our panel will examine current methods of treating chronic illness, how health care reform has improved treatment, and how it can improve further. What do we mean when we say “chronic illness?”

Minnesota Physician Publishing’s forty-second Minnesota Health Care Roundtable examined the topic of treating chronic illness.

Five panelists and our moderator met on Oct. 30, 2014, to discuss this topic. The next roundtable, on April 23, 2015, will address The New Face of Health Care: Expanding medical professional relationships.

Dr. Burns: Chronic illness is a long-lasting condition we cannot cure but can often control.

Mr. Starnes: Can “illness” and “disease” be used interchangeably with “chronic?”

Dr. Sulik: I prefer “condition” because we’re talking about illness requiring ongoing care and management.

Dr. Twynham: I like “condition” because stigma’s associated with “disease” and “illness.”

Ms. Taylor: I agree, “condition” is much less stigmatizing.

Ms. Benson: Thinking about chronic conditions allows us to begin identifying the support needed.

Mr. Starnes: Conditions that fit the standard definition of a chronic condition include diabetes, congestive heart failure, and asthma. Obesity and Alzheimer’s are not in that category.

Do we limit access to care or increase the cost of care by limiting what we consider chronic?

Dr. Twynham: Absolutely. Most of my morbidly obese patients represent only the tip of the iceberg of those who are morbidly obese. In our society they’re stigmatized and rejected by the medical profession, partly because we feel inept; we don’t have a magic cure. As a result, we’re uncomfortable taking care of them. These patients are attuned to caregivers’ emotional cues and when they’re told, if you just tried harder you could lose that weight, they don’t go to health care providers and their obesity escalates into type 2 diabetes, high blood pressure, pulmonary hypertension, sleep apnea, asthma, cancers, congestive heart failure, and they reenter the system when a lot could have been prevented by earlier

20

Treating chronic illness Is health care reform helping?

intervention. This problem will increase dramatically as obese teenagers become morbidly obese 20-year-olds and start dying in their 30s and 40s.

Mr. Starnes: The way patients are entered into the system affects their ability to obtain coverage. Is there benefit in expanding coding for chronic conditions?

Dr. Sulik: Children with significant emotional behavioral disorders; adolescents, young adults, and adults suffering from recurrent depression and severe anxiety, trauma, post-traumatic stress disorder, trauma-related disorders: These conditions really do cause a chronic condition by creating significant chronic vulnerability for these individuals. Those most severely debilitated and faced with the stigma that their illness is not considered chronic are those with addictions. The only way we will ever overcome these illnesses is to treat them as chronic health conditions and provide the right type of financial and ongoing supports for them.

The idea that we can separate mental health and mental illness from physical

Minnesota Health care news March 2015

illness has been proven wrong. Our future is realizing these complicated conditions involve multiple internal and external factors and physical components as well emotional, cognitive, and spiritual components.

Dr. Twynham: I support that. Many of my patients, whether for cancer or morbid obesity, as they move through treatment of their physical condition, often develop emotional conditions that adversely impact their ability to comply with medications or other treatments. In health care reform, a lot of talk has been about the medical home, where spiritual, emotional, physical, psychiatric care, and social services are coordinated under one roof. That might be the model to move toward.

Ms. Benson: If we included dementia among chronic conditions, we could take a more holistic approach to supporting people with dementia and their support network. Engaging each care team member in helping that individual manage their chronic conditions would produce significant positive outcomes, including compliance with medications and other treatment strategies.

Mr. Starnes: Does anyone have examples of how health care reform has affected treating chronic conditions?

Dr. Sulik: Health care reform emphasizing integrating health care and behavioral health care has finally achieved national recognition. Most accountable care organizations and payers are examining how to integrate effectively. The driving force behind that has been the emphasis on reducing total cost of care. In the last three to five years, data has shown that, regardless of your health condition, the cost of treating it will at least double or triple if you have a co-occurring behavioral health condition. The cost of treating diabetes or congestive heart failure doubles or triples if someone has depression, anxiety, or an addiction. If you have depression and diabetes, the cost of treating diabetes increases at least four-and-a-half times. If you have depression, a substance abuse disorder, and diabetes, the cost of treating your diabetes increases probably 11 times.

Mr. Starnes: So, the Accountable Care Act encourages paying attention to behavioral health issues in order to reduce the cost of treatment.

Minnesota health care roundtable Dr. Sulik: We in health care are now charged with population health, a very different mindset and accountability than treating somebody with an illness. Population health requires a lot of education, support, engagement, different types of collaborations, and partnerships.

Mr. Starnes: Is access to bariatric surgery or postoperative care for cancer patients improving as a result of health care reform?

Dr. Twynham: Access to care for morbid obesity has continued to decline since 2007. Insurers increasingly restrict who is a candidate for bariatric therapy. A lot of barriers are deliberate hoops to jump through. Many patients don’t have the emotional or social resources to jump through those hoops and don’t get care. From the moment someone comes to one of my educational seminars interested in bariatric surgery to the day they have an operation averages nine to 15 months. What other chronic illness takes that long to get care? I do not see that improving under the Affordable Care Act because many insurers have exclusions for morbid obesity. In terms of cancer care, health care reform has opened doors.

Especially for very-low-income people, who now can afford follow-up visits.

Mr. Starnes: Health care reform was supposed to eliminate denial of coverage for preexisting conditions. Has anyone seen seniors with chronic conditions benefit from reform?

Ms. Taylor: Diabetes is a long-term condition, so no exclusion for preexisting conditions is a major benefit of the Affordable Care Act. Ms. Benson: There are two outcomes of health care reform so far. Read, building on what you said about behavioral health, one outcome is that we are seeing social services for older adults with chronic conditions being more a part of the conversation. Things like providing home services to help older adults maintain independence. That’s positive. We hope to increase coordination between health care and community social services. The other benefit, although minimal so far compared to the need for it, is additional funding to continue building programs proven to help older adults manage their chronic conditions, like pain management, falls prevention, exercise.

Ms. Taylor: Other things the Affordable Care Act has done for people with diabetes is that hospitalization, prescription medicine coverage, preventive

health services, and chronic disease management are included in the essential benefit set. It also has provided new funding to state health departments to work on obesity, diabetes, heart disease, and stroke. Those funds help state health departments partner with medical associations, businesses, and community organizations to make sure programs are in place that link with the health system and provide supportive care for people in communities. In Minnesota, as a result of the Affordable Care Act we received grant funding from the Centers for Medicare & Medicaid Services to study the impact of incentives on participation and weight loss among people who are on Medicaid and participate in the diabetes prevention program. It’s a yearlong program helping people learn to eat more healthfully and develop the habit of being more physically active in order to lose 5 percent to 7 percent of their weight. This helped us to work with 25 clinics in the Twin Cities area to develop infrastructure needed to work with community organizations, for the Y to offer a diabetes prevention program, and for us to learn how to work with a low-income, diverse, often immigrant population in diabetes prevention.

Mr. Starnes: We’ve heard complaints that health plans essentially deny coverage for preexisting conditions by restricting access to medication for specific conditions, either by limiting formulary options or through excessive copays for certain medications. Has anyone seen this?

Dr. Burns: Yes. Some of my patients have pulmonary hypertension and take a lot of expensive medications. Some patients say, “I can come and see you but I can’t handle six or seven different medications” that are critical to keep them out of the hospital.

Dr. Twynham: Similarly, because bariatric patients eat a much smaller amount of food they often lack specific vitamins and minerals. If vitamin D3 is available over the counter it’s not reimbursed, and can cost upward of $100 a month.

Mr. Starnes: What are the biggest obstacles to improving your patients’ outcomes?

Dr. Burns: In chronic congestive heart failure, one of the biggest obstacles is patient compliance with medication regimen, follow-up. We try, especially early after a diagnosis, to see patients very frequently. Patients that comply with recommended appointments and the reinforcement that comes with

Kari Benson, MPA, is the planning coordinator for the Minnesota Board on Aging (MBA), housed at the Minnesota Department of Human Services.

The MBA oversees Older Americans Act programs for the state and advocates on behalf of older adults and their families. Benson facilitates development of the State Plan on Aging by the Board on Aging; coordinates the annual Area Plan process by which regional Area Agencies on Aging are funded; and develops Board policy and guidance for the Area Agencies on Aging to implement the Older Americans Act. She also coordinates policy and strategic initiatives encompassing public, home, and community-based services programs that support older adults and people with disabilities.

Durand E. Burns, MD, is a researcher at the Minneapolis Heart Institute Foundation and a clinical cardiologist practicing with Minneapolis Heart Institute at Abbott Northwestern Hospital. Board-certified in internal medicine and in cardiovascular disease, he completed medical school and a residency in internal medicine at the University of Minnesota Medical School, Minneapolis, and a fellowship in congestive heart failure and cardiac transplant at Rush–Presbyterian–St. Luke’s Medical Center in Chicago. Burns is particularly interested in congestive heart failure, pulmonary hypertension, and heart transplantation.

L. Read Sulik, MD, FAAP, DFAACAP, is chief integration officer for PrairieCare, which provides inpatient psychiatric care to children and adolescents and outpatient care for all ages at five locations in the Minneapolis–St. Paul area. In this role he oversees integration of primary and behavioral health care. He has served in a similar capacity for Sanford Health System, as assistant commissioner for chemical and mental health services at the Minnesota Department of Human Services, and as medical director of child and adolescent psychiatry at St. Cloud Hospital. Board-certified in pediatrics, psychiatry, and child and adolescent psychiatry, Sulik is also a clinical associate professor at the University of North Dakota School of Medicine and Health Sciences and the University of Minnesota Medical School.

Gretchen Taylor, MPH, RD, supervises the Minnesota Diabetes Program (MDP) at the Minnesota Department of Health. MDP aims to prevent type 2 diabetes, improve health outcomes for people living with diabetes, and reduce diabetes-related disparities across populations. Taylor is on the executive team for the Minnesota Diabetes Collective Impact Initiative, whose prevention goal is to make the National Diabetes Prevention Program available and accessible to all for whom it is indicated in Minnesota. She is also the principal investigator on the CMS–funded research study called Minnesota Medicaid Incentives to Prevent Diabetes, also known as “We Can Prevent Diabetes in Minnesota,” which is testing the effects of incentives for weight loss and attendance among Medicaid enrollees participating in the Diabetes Prevention Program in 25 metro area clinics.

Crystal Twynham, MD, FACS, is in independent medical practice as Crystal Twynham, MD, PLC. Board-certified in surgery, Twynham graduated from the University of Minnesota Medical School; served a residency in surgery at Marshfield Clinic/St. Joseph’s Hospital in Marshfield, Wis.; and served as a fellow in bariatric, metabolic, and minimally invasive surgery at the University of Minnesota Medical School.

A bo u t th e Mo d e r ato r Mike Starnes has been the publisher at Minnesota Physician Publishing since 1986. His duties include the production of MedFax, Minnesota Physician, Employee Benefits Planner, and Minnesota Health Care News; directing the Minnesota Health Care Consumer Association; and hosting the Minnesota Health Care Roundtable.

March 2015 Minnesota Health care news

21

Minnesota health care roundtable them often do quite well. But plenty of people miss that appointment and resume eating salty pizza. That’s one of the frustrating obstacles to caring for these patients.

However, I’m very pleased that Twin Cities primary care physicians recognize that congestive heart failure is difficult to take care of—it requires a lot of appointments and follow-ups, and doesn’t happen in a 15-minute appointment—so in my experience, metropolitan-area cardiology programs have experienced much more primary care referral than one might expect. The Heart Institute, where I practice, and other programs have spent a great deal of time in the community educating patients and physicians about how to succeed with heart failure. I think that’s made an impact.

Dr. Twynham: Among morbidly obese patients I see, less than 20 percent of them are referred by their primary provider.

Eighty percent are self-referred.

Dr. Sulik: None of us as physicians can truly care for someone with a chronic health condition. Movement in this country to team-based care is from improved understanding as well as necessity. I cringe when we talk about “compliance” because it implies patients choose to not follow through with instructions. But very often, individuals with chronic health conditions have an obstacle to being able to follow through.

For example, adults in Sioux Falls see their Sanford internists about four to four-anda-half times in a year and a half. However, individuals with a known diagnosis of depression saw their internist 1.1 times over an 18-month period. We know that depression incapacitates someone’s motivation.

Many individuals with chron-

ic health conditions have co-occurring conditions that interfere with the ability to follow through. What it takes to change human behavior is structure, support, education, and repetition in a supportive environment. Team-based care works. We must keep coming up with creative ways of funding that because honestly, that is what impacts total cost of care.

Mr. Starnes: If only 20 percent of obese patients are referred by a physician, how can postponing seeking care turn a chronic condition into an acute crisis?

Dr. Twynham: People don’t want to admit that they have a disease. They don’t care until they come to the ER and Dr. Burns has to admit them for acute heart failure and pulmonary hypertension, and I’m called to see them because they’re 540 pounds and will die without bariatric care.

But, again, the barrier is often stigma.

There is stigma to seeking treatment for obesity surgery. One-third of my patients won’t allow me to talk to family members after their operation and if I do, they ask me to say I removed their gallbladder and not mention I also did a gastric bypass.

There are a lot of issues that interfere with seeking care. There is prejudice from primary care providers who think bariatric surgery doesn’t work. They have the 1950s attitude that somehow I am operating on patients’ brains and changing some psychological aspect. Maybe I am, because surgery changes certain hormones that affect the brain’s eating, appetite, and reward centers. But barriers are really societal, mostly from prejudice.

Ms. Taylor: If we look further upstream at why people are overweight and have other chronic diseases as a result of being overweight, part of that is the obe-

Disparities persist in terms of available interventions.

Kari Benson, MPA

sogenic environment, one that doesn’t make it easy to eat healthfully or be active. We don’t have to be active in order to work. We have a lot of access to high-calorie, highfat, high-sodium, high-sugar, cheap food.

That’s part of the problem. Something we have going for us in Minnesota is that we have the statewide health improvement program that brings $47 million to the state health department, which grants it to local community health boards. Those boards work to reduce obesity and to reduce tobacco use and exposure in their communities by working on policy changes, systems changes, and environmental changes to make it easier to find healthy foods and increase physical activity. It is upstream so there is still a lot we need to do to identify people once they have the beginnings of chronic diseases like prediabetes, or even diabetes, since a third of people with diabetes are undiagnosed.

Ms. Benson: Some obstacles for seniors are basic building blocks of daily life that can make it hard to take action to either prevent onset of a particular chronic condition or to better manage chronic conditions, overall health status. It is access to services like transportation. If they can’t make it to their doctor’s appointment or they can’t get to the pharmacy, trying to follow their doctor’s recommendations, trying to make sure they’ve got healthy food, is hard. The family caregiver role is key but not always identified and supported, so the entire family unit can struggle quite a bit.

Plus, with limited or fixed incomes, there are trade-offs in terms of what older adults choose to spend their limited dollars on.

Mr. Starnes: A point all of you mentioned was having a patient more engaged. You’d think that if they have congestive heart failure they’d stay off the pizza, but apparently not. Can anyone share what works to create a more engaged patient?

Dr. Burns: Patients that, in my experience, do best are ones that comply with the multidisciplinary approach. I spend a lot of time reinforcing the principles, nonpharmacologic therapies, the importance of standing on the scale every day. It’s easy for someone to note that their weight went up three pounds today and three pounds yesterday. Those simple at-home steps are very important. But that is where I come back to saying, in the field of congestive heart failure, the importance of listening to what the multidisciplinary team is telling

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

22

Minnesota Health care news March 2015

Minnesota health care roundtable you, the reinforcement and the education piece, helps a great deal in having patients succeed. Granted, there are a lot of potential barriers for the elderly, the lack of family backup and transportation for many patients, the inability to afford any of the levels of care that we are talking about, those are definite barriers. The frequency,

pursuit of his or her own health is really important as we think about what’s needed to help them. There is good data on identifying those who are low on the engagement scale and targeting them to bring them in for more structured visits. They need more structure, education, and support for their engagement process. That process could be a meaningful opportunity to prepare this individual for changes he or she needs to make.

Mr. Starnes: Let’s talk about the role an employer can play to improve the health of people with chronic conditions. Has anyone seen examples of employer-sponsored programs addressing this?

Ms. Taylor: In Minnesota, there’s the diabetes prevention program. It’s relatively expensive for people to pay for on their own but if it’s in the insurance benefit an

One of the biggest obstacles is patient compliance with medication regimen.

Durand E. Burns, MD

at least initially, of follow-up and time-consuming visits is really what prepares us to succeed in the specific case of congestive heart failure. We pay a great deal of attention to comorbidities and a fairly large number of my patients with congestive heart failure chronically have some degree of depression. A fair number of patients have comorbid conditions regarding their heart and other organ systems, and we try to pay attention to all of those. Those who succeed are usually those that get into it and say, I never knew how much better I could feel and I’m going to keep the ball rolling.

Mr. Starnes: Work has been done regarding how the larger topic of behavioral health can be used to provide engagement strategies for chronic conditions. Can anyone discuss this?

Dr. Sulik: How engaged an individual is in

employer selects and is available to people with prediabetes, it can do a lot to make changes that may prevent or delay onset of type 2 diabetes, and help them develop lifelong habits they need. Even if they do develop diabetes they will be healthier.

Mr. Starnes: Let’s consider how health care disparities relate to chronic illness.

Ms. Taylor: For many chronic diseases there are disparities in morbidity and mortality.

People with diabetes who are non-Hispanic white often have better access to care, better ability to follow instructions or access medications. They may have higher health literacy, which is very important in following through. Nonwhite populations in Minnesota have higher mortality from diabetes and worse outcomes in diabetes management.

Ms. Benson: Disparities persist in terms of available interventions that are proven effective for particular populations. Older adults who identify themselves as other than non-Hispanic white often don’t have a health promotion program that works for them. That’s changing, but it’s definitely something we’re working on and see a great need for.

Dr. Sulik: When I was assistant commissioner at the Department of Human Services, that department and the Department of Health both had initiatives targeting health disparities in Minnesota and promoting public education to improve access to care. Both showed some areas of improvement among ethnic populations except Native Americans and African Americans. The disparity in access to care and how care is provided in these two populations in Minnesota is astounding and needs to be addressed in a very significant manner. A culturally mindful approach to engaging individuals can help overcome some obstacles to feeling comfortable and safe in a health care setting and the desire to seek health care. Also, health disparity isn’t only defined by ethnicity. We don’t think of mental illness as creating a health disparity. People aren’t dying from mental illness, they’re dying from other chronic health conditions because mental illness impedes their ability to access and engage in care. So disparities can be thought of in a very broad sense.

Dr. Twynham: I agree, we need to broaden our definition of disparities. We need to look at disparity in how people make health care a priority. That often reflects ethnic differences; some populations do not make their health a priority. Day-to-day living is a priority. There is great disparity in care provided by primary care providers trying to survive their day of 50 patients. Some are able to help people access the right care and others are too overwhelmed. Lastly, the way information is delivered is vital. Perhaps it’s best delivered by someone viewed as a leader and thought promoter, someone who can influence communities.

Ms. Taylor: We had some interesting community conversations with Native American, African American, Latino, Hmong, and Somali populations to ask what concerns them about diabetes and prediabetes, and what messages might motivate them to visit a provider for testing or to take action in their own lives. There is a great deal of fatalism. How can we change that? Part of it is working within communities.

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

March 2015 Minnesota Health care news

23

Minnesota health care roundtable Ms. Benson: People make the most improvement if they participate in a program delivered by and in their community, with their peers and their culture. Increasingly, we are able to get those types of programs, such as a tai chi program that has been found to be adaptable for a wide range of populations in the Twin Cities metro. We need to do that more.

Mr. Starnes: Let’s see how community-based chronic-condition self-management programs can help. Can anyone share information about them and how they can be utilized?

Ms. Taylor: This is a big focus of work we do in partnership with the Minnesota Department of Health to address needs of people with prediabetes. An estimated 1.4 million adults in Minnesota have prediabetes, one in every three adults. Only 10 percent know they have prediabetes. There is a very effective evidence-based program called The Diabetes Prevention Program (DPP). It was tested through a nationwide randomized controlled trial with over 3,000 participants of all ethnicities. They tested the effects of this yearlong program of 16 weekly sessions and eight monthly sessions. The DPP worked with individuals one-on-one, but it’s been found to be just as effective in a group setting. The original research showed that people who increase their physical activity to 150 minutes a week and lose 5 percent to 7 percent of their body weight reduce their risk of developing diabetes by 58 percent over a three-year period. Even after 10 years, their incidence of diabetes was 34 percent lower than those who didn’t make these changes.

This is a very, very effective program. It is starting to be avail-

able in Minnesota but the main barrier is reimbursement for it. That really needs to be covered. Also, as we heard from Kari with the Minnesota Board on Aging, there is a chronic-disease self-management program. It is a six-week program and can be peer led, but doesn’t have to be. Both programs have standard curricula and are proven effective.

Ms. Benson: In Minnesota, the best-known chronic-disease self-management program is “Living Well with Chronic Conditions.” If someone is activated enough to attend the program, the investment is relatively doable. Participants meet weekly for six weeks with a group of peers. Classes occur in various settings in communities statewide.

Participants share challenges, questions, concerns; see they aren’t the only one dealing with a chronic condition; and help each other. They do action planning and problem-solving. Participants learn skills, build the confidence to tackle health-related problems, and learn to communicate more effectively with health care providers.

up with this wonderful program.” A good example is the YMCA’s ABC program, which stands for “After Breast Cancer.” It provides a yearlong membership to the Y and rehabilitation of arm and chest muscles, restoring patients’ confidence in their body image and overall health. Patients are the best way to get the message to primary doctors.

Mr. Starnes: As we look at improving care for patients with chronic conditions, we must address how to create a better understanding of the role of behavioral health.

Dr. Sulik: We’re horrible at identifying behavioral health conditions. We’re even worse, once we identify them, at getting people access to care. If I’m a family physician and identify a patient as depressed, and refer that patient to see a psychologist or psychiatrist, 50 percent of patients in that situation would not be able to follow through with the referral and would never make the first appointment. If an individual has a substance abuse disorder and I make Dr. Burns: The Heart of New Ulm project a referral, 75 percent will never be able to aims to eliminate heart disease of all forms follow through with that initial appointin New Ulm, Minn. Published data shows ment. Siloing across health care creates decreased incidence of myocardial infarcsuch a fragmented approach to care that we tion (heart attack). This project has potenlose many of our patients, even when we do tial for much wider application in other identify. We need to improve the ability to communities. recognize behavioral health needs. To me, that’s a transformative way of thinking. I’m Mr. Starnes: How can we encourage physicians not talking about only recognizing those to refer more patients to these types of comindividuals suffering from mental illness, munity programs?

I’m talking about recognizing broad-based behavioral health needs. Then we need to Dr. Twynham: Engage patients so that they tell their primary doctor, “Hey, I got hooked consider, how do we engage that individual with resources we are bringing in a collaborative manner into the primary care clinic and the other specialty clinics? Because, honestThe idea that we can separate ly, even in a cardiology clinic you mental health and mental illness encounter the same thing. So we from physical illness has been need to think about ourselves as a broader team working effectively proven wrong. with that individual. As a team L. Read Sulik, MD, FAAP, DFAACAP in health care, we need to think together, train together, educate together, and we need to come together in a different way to work with patients, particularly those with behavioral health needs.

Mr. Starnes: For example, the primary care doctor may see a patient with a chronic condition and recognize that this person needs the services of another type of medical professional that isn’t within that clinic. How do we get that care to that patient?

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

24

Minnesota Health care news March 2015

Minnesota health care roundtable Dr. Sulik: That’s what I’ve been trying to do for the last 15 years: integrate behavioral health and primary health care. In the ideal world, I would have a triage behavioral health person who could do an initial assessment in the primary care clinic so the patient doesn’t have to go someplace else for assessment of behavioral health needs. Then, that behavioral health person or others would be able to provide ongoing coaching and training for engagement and needed behavioral changes, regardless of the patient’s chronic health condition.

Those things have to occur in some manner that reaches patients where they are.

Mr. Starnes: When patients first get a diagnosis of severe heart disease, there likely will be mental issues accompanying it but cardiologists are not psychiatrists. How can these patients be identified and advised?

Dr. Burns: To Read’s point, I think none of us are as good as we should be about identifying mental health or behavioral health issues in our patients. Understand that in congestive heart failure, there are roughly 600,000 to 700,000 new presentations every year. The vast majority are via an emergency department and acute hospitalization. I think it is 5.6 days in the DRG for congestive heart failure hospitalization but the average length of stay is significantly longer. During that time, this newly diagnosed patient is a classic deer-in-the-headlights patient; almost nothing you convey to them in terms of what we need to do registers.

Hence the importance of outpatient follow-up. Over time, the overlay of situational anxiety, depression, etc., may begin to come through. But I freely admit I’m not as effective as I should be at identifying those issues. Perhaps until the person’s family says, Dad’s been holed up in the house for the last two months not wanting to get out and do anything, that triggers me to say something else is going on at that point. It doesn’t hit my radar as much as it should.

Dr. Sulik: Randy, I would want you to have the resources and help you need to meet your patient’s needs, particularly in those crisis situations. That’s one of the biggest hurdles. Early in my career, I did a lot of training of primary care physicians, which just raised their anxiety: “You need to understand depression and anxiety better so you can address it better in your primary care setting.” Well, they’re already so overwhelmed trying to address so much that my thinking started to evolve. We are not talking about just improving our own

abilities as physicians to recognize and deal with everything this patient is coming to us with, but we have to consider who else we need with us to meet this individual’s needs.

Mr. Starnes: Most patients aren’t good at recognizing behavioral health problems themselves. How does this issue affect patients?

That depends on there being a certified diabetes educator available in their clinic or community. In many places, especially outstate Minnesota, it’s not available. Telemedicine helps provide access to diabetes education, but the other problem with diabetes education is that it doesn’t generate revenue for a clinic because reimbursement for it isn’t what it should be. So it’s an ongoing

We need to invest upstream throughout the chronic disease spectrum.

Gretchen Taylor, MPH, RD

Ms. Benson: There is a lot of denial by older adults. They may be focused on near-term issues. The same can be said about early dementia. It’s not until you look back that you realize the individual probably had signs of dementia a long time ago. There is a need for tools that could be used easily but it’s more about bringing that care team together.

Mr. Starnes: It is difficult to go from not having diabetes to having it and seeing this massive behavior change that is required. Accompanying depression is part of this.

Ms. Taylor: When someone is diagnosed with diabetes, we hope they are referred for 10 hours of diabetes education by a certified diabetes educator and that they get personal counseling they need for medication management and behavioral changes they’ll need to make. Diabetes education is available two hours every year thereafter.

problem for people to get the education and support they need. When you’re first diagnosed with a disease that you know you’re going to have for the rest of your life, it is hard to hear, so you need ongoing support.

Depression is a very common comorbidity and that can affect someone’s ability to act.

Dr. Sulik: Something we’ve been trying to do in models of integrated health is to add screening for co-occurring behavioral health conditions and behavioral health needs to the patient visit via electronic health records and patient portals. Just asking one question on sadness and irritability and one question on anhedonia can be a profoundly important prescreen for the risk of depression. That can open the door to conversation about awareness of it. Screening is critical; some prescreening tools are in use.

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

March 2015 Minnesota Health care news

25

Minnesota health care roundtable Mr. Starnes: If you have one chronic condition, you probably have more than one. What can be done for patients with multiple issues?

Dr. Burns: Coexisting significant multiorgan comorbidities are a significant problem in patients with congestive heart failure.

Chronic renal insufficiency, COPD; many of my patients are former long-term smokers and have lung disease causing underlying symptoms. It makes it more difficult to manage, particularly patients with significant chronic renal insufficiency or renal failure. They are at much higher risk for hospitalization and morbidity. Comorbid-

chronic rejection they have received from the medical profession. Then you’re really in a pickle because you now have someone who clearly exhibits signs of early congestive heart failure, pulmonary hypertension.

You can tell they have sleep apnea because they fall asleep while you’re talking to them. They have diabetes, hypertension, hypercholesterolemia, and none of it’s controlled. Much of the nine to 15 months I mentioned is spent preparing people to maximize their physiologic status before an operation. Often that means finding a cardiologist, internist, and endocrinologist. It’s staggering how much coordination of care

People don’t want to admit that they have a disease.

Crystal Twynham, MD, FACS

ities also make it more difficult to treat some patients with a cocktail of indicated medications. No research studies showing medications like ACE inhibitors and beta-blockers to be beneficial included patients over 75. A large percentage of my congestive heart failure patients are 79 or 83, and have comorbidities that would have eliminated them from participation in the studies.

Dr. Twynham: Coordination of care is definitely a problem. Just getting a doctor to the phone so you can talk with them for 30 seconds about the patient to facilitate their care is sometimes impossible. Nothing substitutes for that conversation with the primary provider. In patients with morbid obesity, one-third of them don’t have a primary provider because of stigma and

is required. Their physiology changes so greatly after bariatric surgery that I need to tell their primary doctor they shouldn’t take their antihypertensives or diabetic medications because their blood sugar is normal as a result of the surgery.

Mr. Starnes: One key to treating chronic illness is the cost of medication and medication management. Are there problems with this?

Dr. Sulik: The Minnesota Council of Health Plans in 2008 had data showing that 50 percent of antidepressant prescriptions in Minnesota are never refilled. There is no reason to use an antidepressant for only 30 days and never refill it. That shows how widespread the problem is, that individuals don’t fully understand the purpose of the

medication; how they need to give it time to achieve clinical effectiveness; what that effectiveness should be; how we monitor individuals regarding their understanding of the role of the medication and how it fits into the broader treatment plan; how we monitor them for medication effectiveness; and their adherence to the medication regimen. Monitoring is critical. Teaching, education, engagement, and coaching is another piece that historically, we have not been able to do well enough. When we look at health care cost in this country, much of it is associated with pharmaceutical waste.

If we use genetic assays more to see if the patient has the right enzymes to metabolize these medicines to start with, we might save a lot of pharmaceutical waste, time, and adverse events associated with medications. All that can be accomplished with teaching, education, and monitoring right from the get-go with patients.

Mr. Starnes: Medication cost can be a problem.

Dr. Burns: Many medications can be prescribed as generics; Target or WalMart often have minimal $4 copays for one- or three-month supplies. There are exceptions.

Pulmonary hypertension patients can qualify for administration of beneficial medications that aren’t generics and must be covered by some form of plan. These medications can cost $3,500 a month. Often, these patients take two or three different medications, each of which may cost that much. Nobody can pay that out of pocket. All clinics that care for a lot of these patients typically have staff that know how to jump through hoops to get patients their medications. By and large, we’re having much more luck than ever before getting patients medications.

Some manufacturers have programs for patients that need meds, which is how we approach pulmonary hypertension medications. It doesn’t affect many patients, compared with the huge congestive heart failure population, but once we prove that a patient with that condition will potentially benefit from the medications, we can generally get them covered via sponsored programs.

Mr. Starnes: Let’s talk about where the best support could come from for helping to treat chronic conditions.

Ms. Benson: The family, if it’s nearby. They play a key role in helping the older adult remember all the day-to-day things to bet-

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

26

Minnesota Health care news March 2015

Minnesota health care roundtable ter manage their chronic conditions. It can become a 24/7 job for the family caregiver.

They may need support to maintain their own health and caregiving role. Providing caregiver respite, counseling, or peer support groups, training to better understand the chronic condition their loved one has, and what they can do to better manage those. Their role tends to become more critical as their loved one ages.

Mr. Starnes: Certainly with psychiatric conditions there can be stigma. Does this affect the family caregiver who could provide more help but may want to distance themselves despite love for the family member?

Dr. Sulik: Four things affect treatment of chronic conditions: stigma, misperception, misunderstanding, and misdiagnosing behavioral health conditions. So often, there is misunderstanding about how depression, anxiety, trauma, bipolar disorder, and schizophrenia manifest and affect individuals and those around them. If you’re a family member trying to help someone very anxious, they’ll trigger your own anxiety.

Family caregivers need to be aware how support impacts them.

Ms. Taylor: Someone with diabetes needs support to eat healthfully and be physically active, and it can be a fine line; the person with the illness needs to be responsible and doesn’t want to be nagged. Family members can be very supportive, as you said, Kari.

An example from the Diabetes Prevention Program is an African American couple both diagnosed with prediabetes. They went to this year-long program together and said afterward, part of why we were so successful is that we did this together, we’re both on board to make changes, and we ended up successfully losing weight we needed to lose and maintaining that loss.

Mr. Starnes: More improvement in treating chronic illness needs to be made. What can be done at a state and federal level?

Dr. Burns: What we need to do in congestive heart failure is prevent hospitalizations, particularly rehospitalizations. That’s important on the federal as well as the individual hospital level. For a congestive heart failure patient that is hospitalized and then rehospitalized, Medicare and most private payers will not pay for rehospitalization if it occurs within 30 days. So one of the main goals for the federal government and individual hospitals, in terms of cost savings, is to prevent 30-day rehospital-

izations. One very important aspect of cardiovascular disease that has improved in this country and in western European countries is survival after an acute heart attack. Rapid response to patients having acute heart attacks has begun decreasing the incidence of fatal heart attacks. This involves the so-called level 1 heart attack program, in which patients are recognized in their community hospitals immediately as having a heart attack, and if too far away from appropriate care, helicoptered to a center that can perform angioplasty and put in stents. It has decreased mortality but created more patients with congestive heart failure. They survive their heart attack but end up with decreased heart function and enter the inexorable cycle of chronic congestive heart failure, perhaps requiring hospitalizations. What can the federal government and private payers do to further decrease expense, morbidity, and mortality in congestive heart failure? Continue funding more research. There hasn’t been too much new development in chronic heart failure management in many years, but a new medication that has been researched in Europe shows great promise. We haven’t done research in the United States on that medication yet, so the next step is to go through the FDA process.

Mr. Starnes: To wrap up this discussion, what are the most important things that can be done in treating chronic conditions to achieve the Triple Aim of increased access to care, lower costs, and improved patient health?

Dr. Burns: Improving access to care for people who have never carried insurance and have a preexisting condition that precludes them from getting insurance. I’ve started seeing patients who couldn’t afford office visits because they lacked insurance and now have it. As I understand it, 95 percent of Minnesotans now have some form of medical insurance. Giving patients the opportunity to establish with a primary care physician who can refer them to a specialist will reduce costs and, I strongly believe, improve outcomes.

Ms. Benson: Supporting self-management by older adults. It is very important to have an ongoing funding stream/reimbursement for group education/self-management programs. These have been proven effective in decreasing unnecessary health care utilization up to three years after somebody goes through a six-week program, which is remarkable. They lead to improved out-

comes and improved access to care. That’s an important piece but we need other forms of self-management support that are more costly to provide but less costly than emergency room visits, hospitalization, and recovery. For example, providing someone with support they need in the way they need it given, whatever their level of engagement. Do they want to attend a group program? An online class? One-on-one intervention at home? Those are interventions and resources we would like to see but are more difficult to make widely available.

Dr. Sulik: Now that we are accountable for population health, if we develop health care homes for individuals with chronic health conditions that are patient- and family-centered and engage patients and families fully and collaboratively, and integrate primary and behavioral health care teams, we can achieve significantly improved experiences of care and clinical and functional outcomes. It will save dollars, reduce hospitalizations and emergency room visits, and reduce complications of poorly integrated care. The Affordable Care Act gives us an opportunity but it’s what we do with it that matters.

Dr. Twynham: We need to assess our population’s health and identify best practices for each chronic condition and how to deliver them. One delivery model may work in one community, but not in another. Most of our population is poorly educated about wellness. We need to completely revamp health education from prekindergarten up.

We need to incentivize individuals to want to be healthy; if you want to take the stairs, you can’t even find them in some buildings.

Ms. Taylor: To avoid a future in which one in three people have diabetes, we must prevent obesity. We have to continue investing in healthy communities to make it easier to make healthier choices. And I agree with Crystal, we need to educate everybody about food and physical activity. We need to continue to build on our own state health reform efforts to provide obesity prevention, early detection, and expanded treatment. We need funds at the state health department. We have no state funds for treating diabetes; all our funding depends upon federal money. We need to invest upstream throughout the chronic disease spectrum.

M i n n e s o t a h e a l t h c a r e r o u n d t a b l e sponsored by

March 2015 Minnesota Health care news

27

Take care

Long-term care costs

You can own your future

By LaRhae Knatterud, MPA

T

here’s a 70 percent chance you’ll eventually need long-term care, such as help with dressing and household tasks. You may need it sooner than you think; 40 percent of U.S. residents currently receiving such care are age 64 or younger. However, most people don’t plan for this.

The Dayton administration’s “Own Your Future” initiative encourages Minnesotans to plan for their long-term care, including

In the next issue...

how to pay for it. Here’s how to start.

Four key questions to address are: 1. Who can you count on for help?

Long-term care is typically provided by spouses, daughters, and daughters-in-law. Have honest conversations with your family about how they can help.

Elder and Advocacy Services I am passionate about being an advocate for the elderly and disabled, including in maltreatment, injury and wrongful death claims.

• Alcoholism • Proton pump inhibitors • Diverticulosis

Other services include: • nursing home litigation • health care agent appointments • elder abuse and neglect • elder mediation • nursing home resident rights • estate planning • speaker Please contact: Suzanne M. Scheller, Esq. Scheller Legal Solutions LLC 6312 113th Place North Champlin, MN 55316

763.647.0042 suzy@schellerlegalsolutions.com

www.schellerlegalsolutions.com 28

Minnesota Health care news March 2015

2. Where do you want to live?

Increasingly, home and community services are available to facilitate “aging in place,” i.e., aging at home. These include services provided by community groups and volunteers (a boon for those on limited incomes) as well as private-pay support, paid for by the recipient.

• Private health insurance doesn’t pay for most long-term care.

• Medicare and Medicare supplemental plans only cover skilled short-term care in a nursing facility or at home following a three-day hospital stay.

• Medicaid (called Medical Assistance or MA in Minnesota) is a major payer of long-term care. However, people become eligible for this help only after they spend most of their resources to pay for health and long-term care or if they have very limited income and assets.

If you need to move, where can you go?

• Research one-level options in your community or close to family, such as apartment complexes with elevators.

• M innesota’s senior housing options offer various levels of services. Get a list of “housing with services” at minnesotahelp.info and visit several. Make sure you understand which services are provided and how you receive and pay for them.

3. How will you pay for long-term care if family/friends are unavailable?

In Minnesota, the average annual cost of care is: • $20,000/yr. for two to three home health care visits per week.

• Do not depend on Medicare or MA to pay for long-term care. Eligibility and benefits for both programs may change at any time.

Long-term care insurance The way this works: If you are accepted and enrolled (persons with chronic conditions are less likely to be accepted), you pay premiums and the policy pays for covered long-term care services when you need them. Decisions to make about which policy to buy include:

• $40,000/yr. in assisted living. This can escalate quickly if your needs increase.

1. What types of services would you like your policy to cover?

• $70,000/yr. in a nursing facility.

3. How much can you pay in premiums?

4. W hich programs don’t pay for long-term care?

• Disability insurance only replaces income when you’re unable to work. It ends when you’re able to work again.

2. How much do you want to receive in benefits?

It’s important to be aware that people with chronic or serious health conditions may find it difficult or impossible to obtain longLong-term care costs to page 30

Center for Sexual Health Compassionate patient care in sexual health for individuals, couples and families of all backgrounds and ages. Patient assessment and treatment is available in the areas of relationship and sexual problems therapy, compulsive sexual behavior, sexual offending, transgender health services and sexual abuse.

HIV counseling, as well as psychological treatment for people living with HIV/AIDS. Our physicians provide care for many medical conditions including (but not limited to) the following: • Compulsive sexual behavior

• Premature ejaculation

• Emotional pain or physical pain with sexual activity

• Sexual abuse

• Erectile dysfunction (ED)

• Sexual desire discrepancies

• Gender identity disorder

• Sexual harassment

• Gender exploration for children and adolescents

• Sexual offending

• Hepatitis

• Sexual orientation

• Mental health

• Sexual problems

• Orgasm problems

• Transgender health Treatments

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

612-626-4702 | www.umphysicians.org March 2015 Minnesota Health care news

29

Long-term care costs from page 29

term care insurance. It is typically easier and less expensive to obtain by people who buy it in their 40s or younger, before medical problems are diagnosed. Of course, buying it at a younger age means that premiums will need to be paid for a longer time than if the insurance is purchased by an older person.

Financing In addition to long-term care insurance, other ways to pay for longterm care include: Personal savings Personal income and savings may be an option if you: • Earn enough to save the amount needed to cover the cost of long-term care.

Life insurance options Long-term care riders A life insurance policy with a long-term care rider has a higher premium than a similar policy without the rider. Once you satisfy the requirements of the long-term care provisions, the policy pays for your long-term care.

Accelerated death benefit This pays you a percentage of your life insurance policy benefits while you are alive. You may use these benefits to pay for your longterm care if:

After age 65, HSA funds may be used for long-term care.

• Have health conditions that make you ineligible for insurance.

• I ntend to use your long-term care savings for other purposes if it’s not needed for your care.

• If you don’t save enough or don’t start saving early enough, your personal savings and income probably won’t cover your costs.

•

ou are diagnosed with a Y terminal illness.

•

ou are diagnosed with Y an illness that limits life expectancy.

•

ou require permanent Y placement in a nursing home.

Viatical or life settlements Viatical settlements sell your life insurance policy to a viatical company when you are terminally ill in return for immediate cash.

The viatical company pays you a portion of the death benefit and becomes the policy’s beneficiary. A health screening is required.

Have You heard about the BioMat? www.mppub.com

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:

Read us online Wherever you are!

• Stress and anxiety relief

• Core body temperature support

• Improved mobility and flexibility

• Improved circulation

• Chronic and acute pain relief

• Lymphatic drainage

• Arthritis, neuropathy and fibromyalgia relief

• Relief from persistent infection

• Detoxification

Mini BioMat 33"x20" $650.00

• Speeds healing of soft tissue injuries

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

30

Minnesota Health care news March 2015

Life settlements sell your life insurance policy to a third party.

However, you needn’t be terminally ill and no health screening is required. However, you must meet age requirements, typically age 74 for women and 70 for men.

These settlements may be options if you: • Have life insurance and need cash for long-term care.

• Don’t have family or friends to care for you.

Health savings accounts (HSAs) HSAs require people to participate in a high-deductible health plan, with or without involving an employer. Someone may contribute to an HSA through pretax salary without reporting contributions as income on federal income taxes. When HSA monies are withdrawn they are also tax-free, making these accounts an attractive way to save money for health expenses. After age 65, HSA funds may be used for long-term care.

Home equity Options that tap your home equity include selling your home, a home equity loan, or a reverse mortgage.

Selling Consider several factors as you decide whether to stay at home or move. Can you maintain the home, especially if your mobility becomes limited? Are there people nearby to help you? For people who may need help, selling the home and using the proceeds to move to a

General Surgeon Join our phenomenal group of physicians and mid-levels in Glenwood to experience the ideal balance between your professional and personal life.

We are actively recruiting a full-time, BC/BE general surgeon.

Our comprehensive healthcare system combines the best of a clinical and hospital practice in a friendly and professional environment. GRHS physicians enjoy excellent supportive administration, medical staff and nursing, and 24-hour on-call Ancillary services. The recently remodeled hospital facility and clinics provide advanced technology and equipment to help us deliver exceptional care to our patients. Our service area has a population of 15,000.

setting providing more support may be wise.

Home equity loan A conventional home equity loan might pay for future needs for someone with significant equity in a home. There are two types of home equity loans. A loan provides one lump sum; a line of credit provides a specified amount of credit.

Reverse mortgage A reverse mortgage is available to homeowners age 62 and older. It provides access to the home’s cash value without selling it. The money can be used for any purpose.

Consider reverse mortgages or home equity loans if you: • Have limited retirement income from other sources.

• Want to age in place.

Start planning now Own Your Future is currently working to develop more ways to pay for long-term care that are affordable and suitable for middle-income households. It may be several years before these options are available, so start planning now. For additional information, visit mn.gov/ownyourfuture and call Senior LinkAge Line, (800) 3332433, to speak to a trained professional about your options.

LaRhae Knatterud, MPA, is the director of Aging Transformation, Continuing Care Administration, at the Minnesota Department of Human Services.

Discover

the benets of yoga.

Right now, new students get a FREE WEEK of unlimited yoga.

Glenwood is a family-oriented community with an excellent school system.

The beautiful area is a popular playground for those who enjoy year-round outdoor activities. From swimming, biking, golfing and fishing to hunting, skiing, ice-fishing and snowmobiling, opportunities are abundant. Located 15 minutes from Alexandria, 1-hour from St. Cloud, and halfway between Fargo and the Twin Cities, we have convenient access to shopping, live theatre, cultural events and professional sports games.

Basic Qualifications • Must have a doctorate degree from an accredited school • Must be licensed or eligible to be licensed in the state of MN • BC/BE • Full-time

See you soon at any one of our 8 Minnesota locations Eden Prairie • Edina • Minneapolis • Minnetonka St. Louis Park • St. Paul • Stadium Village • Uptown

For more information call Kirk Stensrud, CEO 320.634.4521 Mail CV to: Kirk Stensrud, CEO | 10 Fourth Ave SE, Glenwood, MN 56334

Email CV to: kirk.stensrud@glacialridge.org

www.glacialridge.org

March 2015 Minnesota Health care news

31

Corporal punishment from page 13

and Subsequent Risk of Children’s Aggressive Behavior” (Pediatrics 2010) gave results from “The Fragile Families and Child Well-Being Study” (1998–2005). This study looked at the behavior of 3- and 5-year-old children and found that the more frequently a child was spanked at age 3, the higher the level of aggression that child showed at age 5, such as arguing, screaming, bullying, and threatening others. Further research revealed that children subjected to even low levels of maternal spanking at age 3 were more aggressive at age 9 and that high levels of spanking by a father at age 5 were associated with lower child receptive vocabulary scores at age 9. (Those scores reflect the ability to listen and understand language.)

as having been physically abused if a caregiver “often” or “very often” pushed, grabbed, slapped, or threw something at them or hit them so hard that they were injured or marks were left on them. A child subjected to repeated spankings would qualify as having been abused. Having an adverse experience in any one category, including abuse, led to a two- to five-fold increased incidence of suicide attempts. The more adverse childhood experiences, the more likely a person was to attempt suicide. In addition, an increased number of childhood adverse experiences also increased the likelihood of developing learning and behavioral problems, alcoholism and substance abuse, sexually transmitted diseases, depressive disorders, and severe obesity.

Physical punishment does not improve children’s behavior.

The “Adverse Childhood Experiences (ACE) Study” is an ongoing collaboration between the federal Centers for Disease Control and Prevention and Kaiser Permanente’s Health Appraisal Clinic in San Diego. It studies how adverse experiences during the first 18 years of life affect a variety of health behaviors and outcomes. Risk factors studied include multiple stressors, such as family dysfunction (parental substance abuse, maternal depression, etc.) and child abuse and neglect. People responding to the study’s questions are defined

Discipline that works Reward-based systems, natural consequences, temporarily losing privileges, time-outs, and positive parenting strategies help children learn self-control and boost their self-esteem rather than hurt it. By using such methods, parents teach children in the best way possible, by being models themselves of how to deal with stress and conflict in a nonviolent manner.

Sarah Lucken, MD, is board-certified in pediatrics, practices at Hennepin County Medical Center, and is a member of the Minnesota Chapter of the American Academy of Pediatrics.

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

32

Minnesota Health care news March 2015

Minnesota

Health Care Consumer Association

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

SM

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

www.mnhcca.org

Join now.

“A way for you to make a difference�

March 2015 Minnesota Health care news 33 NOVEMBER 2012 MINNESOTA HEALTH CARE NEWS 33

Chronic kidney disease from page 15

with sugar, but sugar can hide in some surprising places. For example, it can lurk in sandwich bread and salad dressing. Too much sugar can lead to health problems such as diabetes and obesity, both risk factors for kidney disease. Cut back on sugar intake, and your waistline and kidneys will thank you.

4. E xposure to contrast dyes commonly used in imaging. It’s important to ask your physician to check your kidney function before you undergo any radiologic procedures such as CT scans, X-rays, and angiograms.

Any dyes injected into your body as part of these tests can cause serious kidney problems, including acute kidney injury.

5. C onsuming high-sodium foods.

Large quantities of sodium can increase blood pressure levels. High blood pressure damages the kidneys over time and is a leading cause of

kidney failure. The typical American diet has been estimated to contain about 3,300 mg of sodium per day, a figure substantially higher than the 2,300 mg daily maximum (about a teaspoon of salt) recommended by the government for healthy adults. The allowable maximum daily intake drops to 1,500 mg for those with health conditions such as high blood pressure or kidney disease. Start reducing your salt intake by cutting back on processed foods and resisting the urge to pick up the saltshaker. Another way to lower dietary salt intake is by following the Dietary Approaches to Stop Hypertension (DASH) Diet (www.dashdiet.org). A high salt intake coupled with obesity is a recipe for disaster.

When to contact your physician Most people may not have any severe symptoms until their kidney disease is advanced.

However, you may notice that you: • Feel more tired and have less energy • Have trouble concentrating • Have a poor appetite • Have trouble sleeping • Have muscle cramps at night • Have swollen feet and ankles • Have puffiness around your eyes, especially in the morning • Have dry, itchy skin • Need to urinate more often, especially at night Learn more about kidney disease and how you can prevent it by visiting the National Kidney Foundation at www.kidney.org

Paul Olson, MD, FNKF, is board-certified in nephrology, practices at Ridgeview Medical Center, and is a Fellow of the National Kidney Foundation.

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited.

For more information, please visit www.mnhcca.org. We are pleased to present results of the most recent survey.

30 25 20 15 10 5 0

Strong

Good

Limited

Very limited

None

34

50 40 30 20 10 0

Hypertension

High cholesterol

Diabetes I’m very Smoking overweight

35 30 25 20 15 10 5 0

Daily

Regularly Sometimes

Rarely

Never

5. When I visit my primary care physician, we discuss PAD. Percentage of total responses

Percentage of total responses

4. I have one or more of the following PAD risk factors (check all that apply).

40

None

Minnesota Health care news March 2015

100 80 60 40 20 0

3. I experience numbness or coldness in my feet.

Percentage of total responses

35

2. I experience cramping and pain in my leg muscles.

Percentage of total responses

Percentage of total responses

1. My understanding of Peripheral Artery Disease (PAD) is:

Every Regularly Sometime times

Rarely

Never

40 35 30 25 20 15 10 5 0

Daily

Regularly Sometimes

Rarely

Never

S:9.75”

Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].

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

11/19/13 8:09 PM

S:12.25”

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 ® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + Victoza + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® + Metformin + Placebo + Metformin + Rosiglitazone All Victoza Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharma® ceuticals, 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