Minnesota Health care News June 2014 by Minnesota Physician Publishing

May/June 2014 â&#x20AC;˘ Volume 12 Number 6

New drug therapies Ken Dornfeld, MD, PHD, and Catherine A. McCarty, PHD, MPH

Uterine cancer Annie Tan, MD, PHD

Hospital-to-home transition Rahul Koranne, MD, MBA, FACP

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©2014 Lifestyle Lift.® Lifestyle Lift® offers surgical and non-surgical procedures performed under local anesthesia. Single procedures take about one hour to complete but more time may be required for multiple procedures or to achieve best results. Most Lifestyle Lift patients return to normal activities in about a week but some need extra healing time, particularly if they have multiple procedures. Lifestyle Lift medical procedures involve a certain amount of risk. Ask your Lifestyle Lift physician and review the consent forms to nd out more about your individual case and what you can expect. Patients depicted are compensated and have given their permission to appear. Photos are from various doctors and are for illustrative purposes only and do not constitute a promise or representation of any particular outcome or experience. Each patient’s experience, recovery and results will be unique depending on their skin, age, health and other individual factors. $250 off all surgical procedures, naturalyn and full face laser. Coupon will be applied to LSL procedure regular price or regular package price, cannot be combined with any other offers or promotions. Cannot be applied to past procedures. Only one coupon per customer. Duplicates coupons are not valid. Coupon is non-transferrable and not redeemable for cash. Coupon must be redeemed at time of purchase. Offer is subject to Medical Clearance. THE PATIENT AND ANY OTHER PERSON RESPONSIBLE FOR PAYMENT HAS A RIGHT TO REFUSE PAY, CANCEL PAYMENT, OR BE REIMBURSED FOR PAYMENT FOR ANY OTHER SERVICE, EXAMINATION, OR TREATMENT THAT IS PERFORMED AS A RESULT OF AND WITHIN 72 HOURS OF RESPONDING TO THE ADVERTISEMENT FOR FREE, DISCOUNTED FEE, OR REDUCED FEE SERVICE, EXAMINATION, OR TREATMENT.

IMAGINE HOW GREAT YOU WOULD FEEL LOOKING IN THE MIRROR

May/June 2014 • VoluMe 12 nuMber 6

4 7 8 10 12 14 16

NewS

CALeNdAr

MINNESOTA HEALTH CARE ROUNDTABLE

SPeCIAL FoCUS: CAreGIvING

PeoPLe

PerSPeCtIve Eric Meininger, MD, MPH Gillette Children’s Specialty Healthcare

10 QUeStIoNS

20 22

Jim Bradshaw Bradshaw Funeral & Cremation Services

PUBLIC heALth Abbey’s hope By Alan Korn, JD

tAKe CAre

Patient-physician communication By Scott Benson, MD

woMeN’S heALth Uterine cancer

By Annie Tan, MD, PhD

24 26 28

hospital-to-home transition By Rahul Koranne, MD, MBA, FACP

Coordinating home health care and medical care

By Joyce M. Konczyk, LSW, and Anita Raymond, LISW, CMC

eNvIroNMeNtAL heALth

Antibacterial products By Johanna Kertesz, MS

GeNetICS

New drug therapies

By Ken Dornfeld, MD, PhD, and Catherine A. McCarty, PhD, MPH

oPthALMoLoGy

Statins and cataracts By Y. Ralph Chu, MD

editor’s note Staff retirement and related changes create a production delay with this edition. As a result, the May and June issues have been combined.

Background and focus: As tools and techniques for treating chronic illness have expanded, so have methods and mechanisms of provider reimbursement. More people now have access to care, and with this comes a heightened awareness of the impact of social determinants on health. The transition to rewarding physicians for maintaining a healthier population is slow but the promise is clear. Treating chronic illness remains an area of high-volume use and, improperly managed, quickly becomes an area of high cost. Objectives: We will evaluate changes that health care reform is bringing to chronic illness care. We will examine new community-based partnerships that are forming to address prevention, compliance, and better identification of risk. We will look at specific diseases and how workplace solutions, insurance companies, clinics, hospitals, long-term care facilities, and home care providers are working together to lower costs and improve outcomes. Please send me ____ tickets at $95.00 per ticket. Mail orders to Minnesota Physician Publishing, Inc., 2812 East 26th Street, Minneapolis, MN 55406. Tickets may also be ordered by phone 612.728.8600 or fax 612.728.8601. Name Company Address City, State, ZIP

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

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News

Little Change in State’s Uninsured Children Rates The percentage of children in the U.S. who lack health insurance dropped from 9.7 percent in 2008 to 7.5 percent in 2012, the most recent year for which data is available, according to a new report from the University of Minnesota’s State Health Access Data Assistance Center (SHADAC). The report also shows substantial gains in coverage for children who historically have tended to be uninsured, such as those from non-Caucasian, Hispanic, and low-income families. The study revealed that Minnesota was not among the states whose rates of uninsured children declined. However, public insurance offset declines in private coverage, which experts say helped keep the rate of uninsured children from rising. Six states had rates fall by 5 or more percentage points, including Oregon, Florida, Delaware, Missis-

sippi, South Dakota, and Idaho.

gain coverage.”

Historically, Minnesota has had one of the lowest rates of uninsurance in the U.S., although this is not true for children. In 2012, 22 states had lower rates of uninsured children than Minnesota. Among children in low-income families, 31 states have lower rates, up from 21 states in 2008.

“Reducing the number of children who lack health insurance has been a focus of state and federal policy-makers for years, and it’s encouraging to see that tremendous progress has been made,” said Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation, the organization that funded the report.

No state showed increased rates of uninsured children between 2008 and 2012, however. Rates varied between a high of 17 percent of children in Nevada to a low of 1.4 percent in Massachusetts. “This report provides an important baseline for measuring the effects of the Affordable Care Act on uninsured children over time and across states,” said Lynn Blewett, PhD, director of SHADAC and a professor at the University of Minnesota School of Public Health, Division of Health Policy and Management. “As eligible parents sign up for free or low-cost health insurance, more children will also

MAFP Announces Family Physician of The Year Sheldon Burns, MD, Edina Family Physicians, has been named 2014 Family Physician of the year by the Minnesota Academy of Family Physicians (MAFP). The award is presented annually to a family physician that represents the highest ideals of family medicine, including caring, comprehensive medical services, community involvement, and service as a role model.

Burns has been a family doctor in Minnesota for almost 40 years. In addition to his clinical practice, Burns serves as the medical director for the Minnesota Timberwolves, Lynx, and Wild, and has been the team physician for the Minnesota Vikings since 1985. He has volunteered at 11 Olympic games and is the on-call physician for the Target Center and Xcel Center to treat performers and tour staff that require medical care. Patients, community members, and colleagues nominated physicians across the state. Three finalists were selected and the MAFP board ultimately chose Burns as the award recipient.

Dayton Signs Newborn Screening Legislation On May 6, Gov. Mark Dayton signed a bill removing short timeframes for storing newborn screening data. The bill had passed

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

651.225.7800 • www.pelvicfloorcenter.org For information about other services we provide please visit us at www.colonrectal.org 4

MINNESOTA HEALTH CARE NEWS May/June 2014

the House 69 to 58 and the Senate 36 to 20. Health officials can now retain samples from newborn babies indefinitely, unless a parent refuses to grant the state permission. The law also bans the sale of samples and related test results. “Newborn screening is a critical component of pediatric care—one that saves many lives each year,” said Robert Jacobson, MD, FAAP, president of the Minnesota Chapter of the American Academy of Pediatrics (MNAAP), an organization that supported the bill. Other groups that supported the bill include Children’s Hospitals and Clinics of Minnesota, the University of Minnesota Amplatz Children’s Hospital, Hennepin County Medical Center, Gillette Children’s Specialty Healthcare, Mayo Clinic Children’s Center, Shriners Hospitals for Children–Twin Cities, the Minnesota Hospital Association, the Minnesota Medical Association, the Minnesota Chapters of the March of Dimes, American Heart Association, and the Save Babies through Screening Foundation. Some groups disagree with the legislation, arguing that it violates citizens’ rights. “Governor Dayton clearly disregarded the rights of parents by handing over to the state the initial right of ownership of newborn DNA,” said Twila Brase, president and co-founder of Citizens’ Council for Health Freedom. Other organizations that opposed the bill include the New York-based Council for Responsible Genetics and the American Civil Liberties Union of Minnesota, which called the legislation a “dangerous effort to enable unlimited retention and minimize parental consent, allowing newborn blood samples to be used at the whim of the government and researchers, rather than through the consent of the newborn and their family.”

“Trends show that diabetes education is moving out of hospitals and into the community, so AADE’s accreditation program was created, in part, to encourage diabetes education where the patient is seeking care,” said Leslie Kolb, RN, MBA, director of the diabetes education program at Lakeview. “Lakeview Health’s diabetes program is exactly the type of program we envisioned when we set up our accreditation program in 2009.” Lakeview Health is a nonprofit clinic and hospital system that serves the eastern Twin Cities metro area and western Wisconsin.

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HCMC Reaches 25th Year as Level I Trauma Center Hennepin County Medical Center (HCMC) has reached its 25th year as a verified Level I Adult and Level I Pediatric Trauma Center. It was the first hospital in Minnesota— and one of the first in the nation— to receive this distinction from the American College of Surgeons (ACS). “HCMC was already offering comprehensive critical care management, and we had specialists in emergency medicine, surgery, medicine, and pediatrics who were focused on caring for the critically ill or injured,” said Arthur Ney, MD, a trauma surgeon instrumental in HCMC’s achieving Level I Trauma verification in 1989. “So when the ACS developed criteria to be a trauma center, we were able to immediately upgrade our available resources to meet the national standards.”

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Lakeview Health’s diabetes program has been named an accredited diabetes program by the American Association of Diabetes Educators

According to the AADE website, accredited programs benefit from tools for patients’ self-management goals that allow them to track and report patients’ behavior changes and clinical indicators. In 2009, the AADE received approval from the Centers for Medicare & Medicaid Services to accredit organizations for diabetes self-management training.

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May/June 2014 MINNESOTA HEALTH CARE NEWS

News briefs from page 5

MDH Reports Slight Decrease in HIV/AIDS Cases The Minnesota Department of Health (MDH) has released a report showing a 4 percent decrease in HIV diagnoses, from 314 reported cases in 2012 to 301 in 2013. “Although we saw a slight decrease in the overall HIV cases reported, there are certainly some increases occurring among our communities of color and men who have sex with men that concern us,” said Ed Ehlinger, MD, Minnesota commissioner of health. The data also show that 82 percent of newly reported HIV cases come from within the metro area. Almost one-third were among those age 20 to 29, while no new cases were reported among infants. HIV cases among women increased 22 percent overall, but

the largest increase was found among African-born and Caucasian females. Women of color accounted for 73 percent of all new cases among females.

cerned about the effect on HIV rates. “Some of these STIs can increase HIV transmission or the likelihood of getting infected by two to five times,” said Ehlinger.

momentum, and I’d like to remove doubt about the leadership of the organization and remove the ‘interim’ from his title,” MNsure board chairman Brian Beutner said.

In contrast, cases among men decreased by 11 percent. Male-tomale sex accounts for 62 percent of all HIV cases in men and is the main risk factor among males with known risk factors. Males ages 13 to 24 made up 18 percent of new male cases in 2013.

According to MDH, 10,409 HIV/AIDS cases have been reported since it began recording data on AIDS in 1982 and HIV in 1985. Currently, an estimated 7,723 Minnesotans are living with HIV/AIDS.

Leitz was appointed interim CEO in mid-December when former director April Todd-Malmlov resigned amidst ongoing technical problems with the health exchange website.

“The data tells us that communities that experience inadequate employment, education, income, and housing tend to have higher HIV infection rates,” said Ehlinger. “It’s important that we provide adequate access to HIV prevention education, testing, and treatment and care services for these communities.” The recent report of increased rates among other sexually transmitted infections (STIs), including chlamydia, gonorrhea, and syphilis, have some health officials con-

MNsure Names Leitz CEO and Finalizes Deloitte Contract MNsure’s board of directors has announced that Scott Leitz is now the permanent CEO of MNsure after serving as interim CEO for more than four months.

In addition, the state now has confirmed a nine-month contract with Deloitte Consulting for almost $5 million. Representatives of the consulting company proposed a timeline to complete software work in July, test the system in August and September, and relaunch the overhauled system in October.

According to officials, the board had previously discussed initiating a national search, but decided unanimously to appoint Leitz. “Scott’s created some positive

Are Your Kids Ready?

Are Your Kids Ready? AreMinnesota’s Your Kids Ready? Immunization Law Immunization Immunization Requirements Requirements

Minnesota’s Immunization Law

Minnesota’s New Immunization Law Goes into Effect 9/1/14

Use this chart as a guide to determine which vaccines are required to enroll in child care, early childhood programs, school or private). Use this chart asand a guide to (public determine which vaccines are required to enroll in child care, early childhoodthe programs, and schoollevel (public private). Find child’s age/grade andor look to see if your child had the number of shots shown by the

 Check marks represent number of doses

checkmarks under each vaccine. Children age child 2 mayhad notthe have received all doses. Look at the Find the child’s age/grade level and look tobirth see to if your number of shots shown by the table on the back, shows the age when doses are due. checkmarks underiteach vaccine. Children birth to age 2 may not have received all doses. Look at the table on the back, it shows the age when doses are due. Age: 5 through 6 years Age: 7 through 11 years Birth through 4 years Age: 12 years and older Age: 5 through 6 years Age: 7 through 11 years Birth through 4 years Age: 12thyears and older Early childhood programs For 1st through 6th For 7 through 12th For Kindergarten th Early childhood programs & Child care For 1stgrade through 6 For 7th grade through 12th For Kindergarten & Child care grade grade

Hepatitis A (Hep A) Hepatitis A (Hep A)  Hepatitis B (Hep B)  Hepatitis B (Hep B) 

DTaP/DT  DTaP/DT 

Polio  Polio  MMR  MMR  Hib  Hib  Pneumococcal  Pneumococcal  Varicella  Varicella

Hepatitis B  B Hepatitis 

DTaP  DTaP



Polio  Polio  MMR  MMR

Hepatitis B  B Hepatitis

 tetanus and diphtheria tetanus anddoses containing

diphtheria containing doses



Polio  Polio  MMR  MMR 



Tdap atTdap 7th grade

at 7th grade

Polio  Polio  MMR  MMR  Meningococcal  atMeningococcal 7th grade & at  age 16

 at 7th grade & at  age 16

Varicella  Varicella

  Immunizations recommended but not required: Immunizations recommended but not required: Influenza

Varicella  Varicella 

Immunizations recommended but not required: Rotavirus For infants Rotavirus

Hepatitis B  B Hepatitis

Annually for all children age 6 months and older Influenza Annually for all children age 6 months and older

For infants

Varicella  Varicella 

Human papillomavirus At age 11 -12 years Human papillomavirus At age 11 -12 years

The only children who are not required to be immunized are those who have medical reasons for not receiving certain shots or who are legally exempt because of their parents’ personal beliefs.

MINNESOTA HEALTH CARE NEWS May/June 2014 Exemptions Exemptions

To enroll in child care, early childhood programs, and school in Minnesota, children must show they’ve thesecare, immunizations or fileprograms, a legal exemption. To enrollhad in child early childhood and school in Minnesota, children must show they’ve had immunizations or file a legal Parents maythese file a medical exemption signed byexemption. a health care provider or a conscientious objection

There are important changes that apply to children entering school, child care, and early childhood programs. This means your children may need to get caught up on some of their immunizations between now and the end of the summer. Check with your doctor or clinic if you’re not sure.

PEOPLE Jasjit Ahluwalia, MD, MPH, has been selected as the 2014 recipient of the Duncan Clark Award by the national Association for Prevention Teaching and Research. This award is presented to a physician with a distinguished record of achievement in teaching, research, and advocacy in prevention and public health. Ahluwalia, a professor in the UniverJasjit Ahluwalia, MD, MPH sity of Minnesota Department of Internal Medicine and founding executive director of the university’s Center for Health Equity, has devoted several decades to improving the health of high-risk populations.

Love

Joseph Blonski, MD, board-certified in family medicine and on staff at CentraCare Family Health Center and St. Cloud Hospital, has received the St. Cloud Hospital Physician of Excellence award. Blonski played a key role in developing Project H.E.A.L., an outreach program of the center that seeks to overcome barriers to health care in Central Minnesota by offering free health screenings and basic care to those with little or no insurance. Blonski earned a medical degree from Loyola University of Chicago–Stritch School of Medicine and completed a family medicine residency at Naval Hospital, Charleston, S.C. Alaadin Kandeel, MD, board-certified in allergy and immunology, has joined the Essentia Health– Duluth Clinic. Kandeel earned his medical degree from Jordan University in Irbid, Jordan. He completed residencies in internal medicine at the Erie County Medical Center in Buffalo, N.Y., and in pediatrics at SUNY Downstate Medical Center in Brooklyn, N.Y. His fellowship in allergy and clinical immunology was served at Women’s & Children’s Hospital in Buffalo, N.Y.

James Miner, MD

Ben Mueller, MD, PhD

Alaadin Kandeel, MD

James Miner, MD, is the new chief of emergency medicine at Hennepin County Medical Center (HCMC). Board-certified in emergency medicine, Miner earned a medical degree from Mayo Medical School, completed an emergency medicine residency at HCMC, and joined HCMC’s emergency department in 1999. He is also a professor of emergency medicine at the University of Minnesota Medical School. Ben Mueller, MD, PhD, board-eligible in orthopedic surgery, has joined The Spine Center at Regions Hospital, St. Paul. He completed medical school and an orthopedic surgery residency at the University of Minnesota and a fellowship in spine surgery at Norton Leatherman Spine Center, Louisville, Ky.

Ann Tienor, MD, board-eligible in neurology, has joined the Noran Neurological Clinic’s Minneapolis and Burnsville offices. Tienor earned her medical degree from the University of Minnesota Medical School; completed a neurology residency at the University of Iowa Hospitals and Clinics, Iowa City; and completed a headache medicine fellowship at Loyola University Medical Center in Maywood, Ill.

Pediatric Orthopaedics Appointments: 612.596.6105 www.facebook.com/ShrinersTWI

Care Beyond Cost. Ann Tienor, MD

May/June 2014 MINNESoTA HEALTH CARE NEWS

pErspEctivE

LGBTQ health disparities Promoted by discrimination, preventable by awareness

s implementation of the Affordable Care Act reduces the number of uninsured people in the United States, Minnesota physicians can expect new patients, including those who self-describe as lesbian, gay, bisexual, transgender, or queer (LGBTQ). This is due to the fact that 20.2 percent of LGBTQ in the state report being uninsured, versus 9.8 percent of non-LGBTQ Minnesotans, according to 2012 data.

Eric Meininger, MD, MPH Gillette Children’s Specialty Healthcare Dr. Meininger is boardcertified in pediatrics and internal medicine, practices at Gillette Children’s Specialty Healthcare, St. Paul, and is a former member of Rainbow Health Initiative’s board of directors. Rainbow Health Initiative is a community-based nonprofit organization committed to advancing the health and wellness of lesbian, gay, bisexual, transgender, and queer communities through research, education, and advocacy. The organization was founded in 2001, and offers training programs that help health care providers create environments where LGBTQ patients feel welcome and supported.

Expanded insurance coverage is a welcome step toward rectifying health disparities faced by uninsured people. However, gaining coverage is only the first step to accessing health care. Hurdles remain in the form of discrimination in medical settings.

One in four report receiving poor-quality care because of their sexual orientation or gender identity.

Discrimination nationwide Discrimination can cause stress, and chronic stress can increase the risk of cancer and other diseases, according to the National Institutes of Health. The discrimination/stress/ disease association is supported by research showing that LGBTQ people face both increased discrimination and worse health. Research by the National Gay and Lesbian Task Force and the National Center for Transgender Equality found that 97 percent of transgender respondents reported discrimination at work. This took the form of verbal or physical harassment, being removed from direct client contact, or being fired without cause. LGBTQ people also are more likely to have cancer, mental illness, and other diseases; less likely to obtain recommended health screenings; and more likely to smoke and engage in other unhealthy behaviors. Adding racial health disparities to those faced by the LGBTQ community often results in worse health outcomes for people who belong to both groups. For example, African American transgender women have the highest HIV prevalence—29 percent—of any racial or ethnic group.

Discrimination in Minnesota Rainbow Health Initiative conducts an annual survey measuring the health of the state’s LGBTQ community. This survey of more than 1,800 participants is one of the few sources of information about this population’s health statewide. The survey asks about health behaviors, attitudes about health, and respondents’ experiences with health care. Based on this data, we know that LGBTQ people often have a problematic relationship with the health care system. In the 2012 survey, more than one of every six respondents reported being discriminated against by a health care pro-

vider because of sexual orientation or gender identity. Of those who experienced discrimination, 45 percent specified being discriminated against by a primary care provider such as a doctor, dentist, nurse practitioner, physician’s assistant, or pharmacist. Slightly more than 42 percent reported discrimination by support staff such as a nurse, paramedic, medical assistant, or laboratory personnel. Thirty-two percent reported being discriminated against by front desk, scheduling, or security personnel.

Minnesota HealtH care news May/June 2014

These experiences can cause LGBTQ people to forgo medical care. As one respondent writes, “It is extremely stressful for me to go the doctor ... I will avoid going to the doctor at all costs.” Another respondent writes, “Every time I go to the doctor, I end up wasting time having to justify my gender and the changes I’ve made to my body to the doctor, even if I am [there] for something unrelated to my gender.” Even more common is the perception among members of this population that they receive substandard medical care because of their sexual orientation or gender identity. One in four report receiving poor-quality care because of their sexual orientation or gender identity. This number is even higher among transgender patients (44 percent).

Effects Past experience with discrimination and poor-quality care may cause LGBTQ people to be extremely wary when interacting with health professionals, especially in a clinical environment that is new to them. Health care providers need to be aware of the impact of years of past discrimination and poor treatment when treating such patients. Therefore, additional steps that a provider should take to create a welcoming environment for LGBTQ patients include posting non-discrimination policies prominently in the clinic, using inclusive language on intake forms, avoiding assumptions about a patient’s gender identity or sexual orientation, and providing bathrooms that are not gender specific.

Good care for all Every patient, whether LGBTQ or not, deserves health care without facing discrimination. Health care providers have a responsibility to ensure that all patients receive the best possible care.

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Natural burial... an option. A greener wAy to go

From preparing bodies to burying them in natural settings, the green burial movement is attempting to make death more environmentally friendly and, in some ways, closer to the way it was in the past. A Comparison StaNdard burial

Natural burial

Burial use formaldehyde embalming and long-lasting caskets. they can easily cost $10,000.

the natural, or green burial method starts with the body preparation, which uses no embalming fluid or a non-formaldehyde-based formula. green burials can cost less than $2,000.

A Standard grave site, often landscaped and well-maintained, features a large headstone made of granite or flat bronze. Fertilizer and pesticides are used on the grass. Below ground, a casket made of steel, finished wood and copper rests inside a concrete vault capped by a thick concrete lid. green grAveS delIver more vAlue Prairie Oaks offers you • A less expensive burial option • A way to become a part of the land preservation • A spiritually rewarding experience for your family members

If there’s a headstone, it’s a rock or a piece of rough-cut limestone that’s flat on one side to easily identify the deceased. gPS coordinates are used to spot a grave’s location. Caskets are made of wood, plywood, bamboo, cardboard, cornstarch or wicker. Sometimes only a shroud or quilt may be used to wrap the body.

651-300-9549 MNGreenGraves.com “located” in Inver grove Heights — on Argenta trail between Hwy #55 and Hwy #149 May/June 2014 Minnesota HealtH care news

10 Q u e s t i o n s

Funeral director Jim Bradshaw Mr. Bradshaw is founder and CEO/owner, with his wife, Jayne, of Bradshaw Funeral & Cremation Services, centralized in the Twin Cities.

What drew you to becoming a funeral director? I was brought up to serve others. A friend’s death at age 12, and the fact that a close friend of my parents was a funeral director, also influenced my decision, at age 15, to enter this field. What might people be surprised to learn about your profession? Changes in who enters it. When I entered the mortuary science program at the University of Minnesota 50 years ago, our class of 50 was all men; 45 grew up in families that operated funeral homes. Most of us were in our first careers. Today, fewer are entering this field, 60 percent of entrants are women, fewer entrants grew up in families that operated funeral homes, and most entrants are pursuing mortuary science as a second career. How is your industry regulated by the state? State and federal regulations coincide and basically regulate three areas: funerals, cemeteries, and crematoria (places where cremation is conducted). Most regulations concern embalming, how long a body may be held before cremation, who may have a permit to operate a funeral home or crematorium, and filing death certificates. For example, permission to bury more than one urn or body in the same grave depends on a given cemetery’s rules, not state or federal regulation. There seems to be a trend toward people taking a more active role in their own funerals. What can you tell us about this? Four factors drive this trend. First, divorce may result in blended families, which can make decision-making more difficult since family members may not know who has the right to make final decisions about planning funerals or memorial services. Consequently, someone planning

their own funeral may leave instructions intended to avoid decision-making confusion. Second factor: the Internet. Skype makes it easier for geographically dispersed survivors to gather for memorial ceremonies, so more people can be involved. In addition, consumers’ use of websites to learn about funeral providers instead of planning funerals face-to-face with funeral directors is becoming more popular. Third, approximately 50 percent of the public today is not affiliated with a religion. Therefore, since funeral practices for people in that demographic are not defined by religious tradition, they may feel free to construct their own ceremonies. This may include viewing the deceased even if their religious background may preclude public viewing. Some survivors find that viewing the body helps them to acknowledge that a death has taken place, which helps them find closure. Fourth, hospice encourages families to be part of the dying process. Forty percent of those we serve have experienced hospice. Please tell us about “green” cremation. Pioneered by Mayo Clinic, this method reduces funerals’ carbon footprint by approximately 70 percent and appears to be the most effective method of doing so. One way it does that is by not releasing particulate matter into the air. Traditional cremation uses flame, which releases particulate material into the air in the process of reducing a body to ash. Green cremation uses heated water and potassium hydroxide, which reduces a body to ash without using flame. Green cremation also eliminates mercury emission, which otherwise would arise from flame-cremating someone whose dental fillings contain mercury. Flame-based cremation releases dental mercury into the air because fire vaporizes mercury. Because cremation in general has increased from 1.5 percent in the early 1960s to currently being chosen for more than 50 percent of deaths, people want to minimize its environmental effects.

Please tell us about some of the ways funerals differ between cultural backgrounds. First-generation Americans from certain countries may not accept embalming or cremation, and/or may not want a casket. These countries include Somalia, Laos, Thailand, Viet Nam, and Mexico. Families that don’t use a casket as part of their cultural tradition usually request that the deceased be wrapped in cloth head to toe and placed in a grave without a casket. If the cemetery they choose requires a vault for a body without a casket, the vault is inverted and placed in the ground over the body, allowing the body to return to the earth. Some cemeteries include “green burial” areas, where a casket or vault may not be required.

Hmong family may follow animist customs that require the involvement of a cow as part of the funeral ritual. A cow may be brought to the outside of our funeral home, and a string attached to the cow is brought into the building to make contact with the body. The spirit of the cow thereby passes to the spirit of the deceased so that the cow can provide milk and pull a plow in the afterlife. A funeral provider also may be asked to provide 24-hour continuous visitation for three days for a deceased Hmong person. A Muslim family may ask for care of the deceased person without the use of casket or burial vault. In that case, a funeral director must find a cemetery willing to bury someone without a casket or concrete burial vault.

In your 50 years of service, how have attitudes toward end of life changed? My own attitude has changed. I’ve become more cynical about extravagant funerals. How a body is disposed of is not right or wrong, it is a personal choice. Cremate with water or fire, bury embalmed or unembalmed—it’s up to the individual who has died or their family’s religious or cultural needs. We’ve also seen that bodies prepared for cremation now are dressed more casually, which may reflect a societal trend toward casual dress.

What changes do you foresee in your field over the next 50 years? Funeral homes as they exist today will cease to exist. Family or next of kin will design more personalized funeral proceedings. Families will have a greater role in the care of the body and in designing the memorialization. However, over the years I have observed the pendulum of funeral practice swing widely.

How a body is disposed of is not right or wrong, it is a personal choice.

What are some of the challenges your industry faces? Our industry, along with other caregiving industries, must meet the needs of new immigrants and refugees. We must be the best servants and event planners, and be relevant. Being relevant means providing services needed by people in our new demographics. For example, a

What advice can you give? Clearly articulate your needs and expectations to the funeral provider. Understand that there are two options for cremation, one based on water and one on flame. Shop around to learn about the culture and values of funeral providers; choosing one should not be based solely on who charges the lowest price.

May/June 2014 MINNeSOTA HeALTH CAre NeWS

public health

Abbey’s hope

Pool and spa safety By Alan Korn, JD

n June 2007, 6-year-old Minnesotan Abigail Taylor suffered a horrific injury while swimming in a public pool. That injury ultimately took her life.

Abbey was playing in a wading pool when she unknowingly sat on a drain that was poorly maintained and lacked appropriate safety devices. The drain’s powerful suction eviscerated Abbey: Her small intestine was ripped from her body. After nine months of intensive

medical care that included 16 different surgeries, multiple organ transplants, and several infections, Abbey died in 2008. Abbey’s hope was that no child should ever suffer like she did. In her memory and in response to their daughter’s stated wish, her parents, Scott and Katey Taylor, established Abbey’s Hope Charitable Foundation. The foundation works to make sure that all pools, both public and private, are safe. Legislation Since the foundation’s inception, it has helped the Minnesota Legislature craft and pass the Abigail Taylor Pool and Spa Safety Act, which requires all public pools in the state to be equipped with safety devices that help prevent entrapment and evisceration. The foundation also worked with the U.S. Congress to pass the Virginia Graeme Baker Pool and Spa Safety Act, which does for the nation’s public pools what Abbey’s namesake law does for Minnesota ones.

Catered Living for urban seniors is arriving Nov 2014 with the Green Line at your door! Imagine living with the Fairview Avenue Green Line Station (your passport to the best of both cities plus the airport) at your door! Inside, The Terrace at Iris Park will offer Catered Living, a concierge approach to meeting your needs as they change. In addition, you’ll be part of our campus community - a 5-Star Urban Village for Seniors that offers a continuum of care. Learn more about what The Terrace at Iris Park and the six other residences on our campus have to offer, and how they all set the stage for Lifelong Living! Call Deb Veit for the whole story. 651-632-8800. Or visit EpiscopalHomes.org

MInnESoTA HEALTH CArE nEwS May/June 2014

December 2013 marked the five-year anniversary of the passage of the federal law, which requires all public pools and spas to be fitted with anti-entrapment drain covers. The law also requires all pool drains to have automatic shut-off valves that can sense if the drain is blocked—by a child sitting on it, for example—and shut off the suction. Drain covers Anti-entrapment drain covers degrade over time because they are exposed to pool chemicals, sunlight, and ordinary wear and tear. Even if a cover looks as though it still functions properly, most covers’ life spans do not exceed five years, according to the Independent Pool and Spa Service Association. Consequently, the law requires manufacturers of anti-entrapment drain covers to indicate an expiration date on each cover. Drains that have been used past their expiration date can become ineffective, easily break, or both. This makes them a life-threatening danger to any child in the pool. Pool owners should inspect drain covers as a routine part of pool maintenance during the off-season, and replace them if

needed. operators of public pools and spas must replace expired drain covers even if those covers look functional. Many of the drains installed after the national law went into effect have now reached the end of their useful life and must, by law, be replaced. What you can do In addition to properly maintaining pools and spas, follow these steps to enjoy water safely. Teach pool safety. Make sure children know how to swim, float, tread water, and get in and out of a pool safely. The importance of swimming lessons in saving lives cannot be overstated.

The adult wearing the tag pledges: • To maintain constant visual contact with the children in the designated group, even if a lifeguard is present. • not to drink alcohol, talk on the phone, socialize, or read while watching children. • To keep a phone near the water, to be used only for emergency purposes. • To remain by the water until relieved by a new water watchdog.

Make sure an adult is watching children in a pool, spa, or open body of water at all times.

Learn CPR and first aid. Cardiac arrests are more common than you think, and can happen due to a near drowning. This can occur anytime and any place, including in public or private pools. There are approximately 383,000 cardiac arrests each year, and 88 percent of them happen at home. If this happened to someone right in front of you, would you know what to do?

Hands-only CPr administered by a bystander immediately after someone has a sudden cardiac arrest can triple the victim’s chance of survival. This method of CPr, consisting of chest compressions without mouth-to-mouth breathing, has proven to be as effective at treating adult cardiac arrest victims as CPr that includes mouthto-mouth breathing. Since hands-only CPr is for adults, it’s also important to learn how to administer mouth-to-mouth CPr to children. Install barriers. Each year, approximately 280 children under age 5 drown in swimming pools. Many of those deaths occur in inexpensive, shallow inflatable pools, which are incorrectly assumed to be less dangerous than pools with a deep end. That’s because the sides of inflatable pools are flexible and are often slanted and low, making it easy for a child to climb in quickly if he or she is not supervised.

To receive a free water watchdog Tag, go to AbbeysHope.org and sign the pledge to protect children.

Progress According to the Consumer Product Safety Commission, there has not been a single death in this country in a public pool or spa due to entrapment, entanglement, or evisceration since the national law went into effect in 2008. If your pool or spa has a drain that lacks an anti-entrapment drain cover and an automatic shut-off valve, please: Install them. Together, with proper education and safety precautions, we can prevent the preventable. alan Korn, JD, is executive director of Abbey’s Hope Charitable Foundation.

Help is near.

Private pools should be surrounded on all sides by a 4- to 5-foot-high fence that includes a self-latching gate that can be locked. Spas and hot tubs should be covered and locked when not in use. Avoid dangerous drains. If loose, missing, or broken drain covers are spotted, notify pool or spa operators immediately. Before children enter the water, tie up their long hair or secure it under a swim cap so that it can’t be pulled into a drain and yank scalp along with it. warn children to stay away from drains and other openings.

Our Children’s Mental Health Clinic provides families the treatment and strategies they need when a child is stuggling emotionally.

Be vigilant. Make sure an adult is watching children in a pool, spa, or open body of water at all times.

Psychological Testing & Consultation • Preschool Day Treatment Individual, Group & Family Therapy • Skills Training • and more

Water Watchdog Abbey’s Hope strongly recommends that parents share water supervision responsibilities with other parents. That’s why the foundation created the water watchdog Tag system: The supervising parent or adult wears a water watchdog Tag until he or she passes the responsibility and the tag to the next adult supervisor.

Learn more:stdavidscenter.org/mentalhealth • 952.548.8700

3395 Plymouth Road, Minnetonka, MN, 55305

May/June 2014 MInnESoTA HEALTH CArE nEwS

Ta k e C a r e

Patient-physician communication Don’t let hearing loss get in the way By Scott Benson, MD

chieving the best medical care depends in great part on proper communication between you and your physician. if your doctor understands your medical concerns and your symptoms, he or she can offer the best treatment options. and if you understand your physician’s diagnosis and recommendations, you’re more likely to follow his or her suggestions accurately, have better follow-up, undergo fewer unnecessary diagnostic tests, achieve better health care outcomes, and be more satisfied with your overall health care.

Do you or someone liver impairment? Contact us for a liver screening and find out if you qualify to participate in a research study. • Qualified individuals may receive up to $1,250 • Men and women ages 18+ • Mild, moderate or severe liver impairment • 3-night /4-day study with 1 follow-up visit • Receive all study-related care at no cost • No health insurance necessary to participate

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Minnesota HealtH care news May/June 2014

• Feel confused when people are talking? • refrain from asking questions?

• Have a history of exposure to loud or constant noise?

DaVita Clinical Research

Studies are for research purposes only and are not intended to treat your medical condition.

Self-test if you are uncertain whether you have a hearing loss, here are some questions to ask yourself. Do you: • ask people to repeat themselves?

• turn your head to listen?

8TH ST

Be honest Physicians can help you better if they know about your hearing loss. Don’t be afraid or embarrassed to say that you don’t hear well. it takes an average of up to seven years for a person with a hearing loss to decide to seek help for this condition, often at the instigation of the person’s spouse. (“Honey, you don’t listen to me anymore.”) if you suspect you have a hearing loss but haven’t had it diagnosed officially, please tell your physician. Physicians try to be alert to signals that you might be having trouble hearing, but it is easier for everyone if you are open and honest about your condition.

• sometimes think you respond to your physician’s comments inappropriately?

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All studies are conducted at:: DaVita Clinical Research 825 S. 8th Street, Ste. 300 Minneapolis, MN 55404

this is true for all patients, but sometimes can be harder to achieve for people with hearing impairment. a hearing loss presents a challenge to effective communication. Hearing impairment may make it necessary for you to plan ahead, change your style of communication, and spend a little more time at your appointment. But the improved medical care you can obtain by doing so will be well worth it.

• Have ringing in an ear? if you answered “yes” to any of these questions, you may have a hearing loss. ask your physician to check your hearing. there may be medical reasons for your hearing loss that can be corrected, such as an ear infection. obesity, smoking, and some medications can also lead to hearing loss. in women under 50, taking ibuprofen or acetaminophen two

or more days a week has been linked to an increased risk of hearing loss. other drugs associated with hearing loss include certain antibiotics and chemotherapy medications, aspirin in large doses, and certain diuretics. if your physician rules out medical conditions for your hearing loss, you may want to see an ear, nose, and throat specialist or an audiologist for a complete hearing evaluation. If you are deaf if you have a hearing loss, either partial or complete, you may have to spend more time communicating with your physicians and other health care professionals. Here are some suggestions that have worked well for my patients who have hearing loss. ask your physician to: Establish effective office policies. Your physician should document your hearing loss on your chart and make sure that frontline staff knows when you are coming to the clinic. the physician should remind his or her nurse to greet you face-to-face instead of calling your name in the waiting room. Get your attention. ask the physician to tap you on the arm or shoulder and then make eye contact before starting to speak. that way, you do not miss words at the beginning of the discussion. also ask your physician to acquaint you with the topic of the conversation and to avoid changing the subject without first telling you. Speak clearly. if you have partial hearing loss, ask your physician to speak loudly and slowly, and to avoid using sentences that are too complex. if you hear better out of one ear than the other, make sure you are positioned so your “good” ear is facing the physician. ask your physician to pause between sentences and wait to make sure you have understood what has been said. Keep his or her face visible. as you know, part of the hearing process is watching the speaker’s facial expression and lip movements. ask your physician to keep his or her hands away from his or her face while talking and to refrain from chewing gum. even a mustache or beard can interfere with your visualization. if you need a procedure, make sure you understand everything before you move to the procedure room; it is difficult to have a conversation with a physician whose face is covered up by a mask. Many exam rooms today are equipped with computers for physicians to enter medical information as they work, but often this puts the physician’s back to you. Make sure your physician talks directly to you before turning to the computer. Write it down. Physicians may have to write down more information than usual, including information about your illness, course of treatment, and medications. Bringing an erasable whiteboard may be helpful. You also might want to bring a family member or friend to the appointment with you to write down what the doctor says. if your physician sends a prescription to your pharmacy electronically, ask for a written note so you know what medication to pick up. Ask questions, repeat comments. if your physician asks you questions during the conversation, you are more likely to understand. if you are puzzled by something he or she says, ask to have it repeated or stated in a different way. Use visual aids. Don’t be afraid to ask to see an anatomy chart or the internet during an exam. Having a physician point to something on paper or a screen can be clearer than verbally trying to convey a complicated medical term. Minimize noise, maximize light. ask your physician to turn off

any noise that may interfere with your ability to hear. it helps if the room has curtains and carpets to soften noise levels. also, make sure the room is well lit, with light shining on your physician’s face so you can see his or her expression clearly. Use outside services. some physicians may use teletypewriter (ttY) options available on the computer. You might also ask for a sign language interpreter. it is better to avoid using family or children to fill this role, particularly when discussing highly sensitive topics or when you are under stress. Don’t ignore emotion. emotional and psychological issues, especially depression and anxiety, can be associated with hearing loss. Be sure to address these issues with your physician if they are a concern. Removing communication barriers it is common for people with hearing impairments to have more difficulty comprehending speech when they are tired or ill. if you cannot hear well or are deaf, it can be to your advantage to ask for help with communication during your medical appointments in order to obtain complete, accurate information and avoid misunderstandings. as physicians, we want to provide the best medical care to all of our patients. You can help us remove any barriers to access and communication with you by being open about your hearing loss and letting us know how we can make your visit more effective. Scott Benson, MD, is a board-certified family medicine physician and practices at Apple Valley Medical Center.

May/June 2014 Minnesota HealtH care news

W o m e n ’ s H e a lt H

Uterine cancer You can reduce your risk By Annie Tan, MD, PhD

ancer of the uterus is the fourth most common cancer in women, with an estimated 52,630 new cases and 8,590 deaths from the disease predicted to occur in the United States during 2014. The encouraging news is that this disease has a good cure rate if detected early, and it’s additionally encouraging that there are steps women can take to reduce their risk of developing it.

Who gets it? Cancers of the uterine muscle, called sarcomas, are very rare. Approximately 98 percent of uterine cancer occurs in the uterine lining, or endometrium. For U.S. women, the lifetime risk of developing endometrial cancer is approximately 2.6 percent. A woman’s average age at diagnosis is 61, with 75 percent of cases occurring in women age 55 or older. Fortunately, most women diagnosed with endometrial cancer are diagnosed before the cancer has spread outside the uterus, and can be cured by surgery without additional treatment. Understanding the basics The endometrium is the thin inner lining of the uterus that thickens during the menstrual cycle. In menopausal women, this lining is normally thin and inactive. Endometrial cancer occurs when normal cells in this lining become abnormal and proliferate, causing the lining to grow thicker. Symptoms Endometrial cancer’s hallmark symptom is abnormal uterine bleeding. It is most commonly seen in postmenopausal women who no longer experience any bleeding, even spotting. In women who are still menstruating, abnormal bleeding is considered to be bleeding between periods or unusually heavy menstrual bleeding. Unusual vaginal discharge can also be a symptom. Sometimes, endometrial cancer is detected by an abnormal Pap smear. Other times, it is found incidentally when a hysterectomy is performed. Diagnosis A woman who has symptoms should contact her gynecologist promptly. Her evaluation will start with a pelvic exam, which can identify other possible sources of the bleeding. She may also have a pelvic ultrasound, which is an outpatient procedure often used to further evaluate the uterus for anatomic abnormalities that could explain abnormal bleeding, such as polyps or fibroids.

In addition, ultrasound assesses the thickness of the endometrial lining. A thickened lining requires further examination by biopsy, which can be done in the doctor’s office the majority of the time, MInnESOTA HEAlTH CArE nEwS May/June 2014

but sometimes needs to be done in an operating room. A biopsy is a procedure that removes a tiny piece of tissue for analysis. Tissue analysis is the definitive way to diagnose endometrial cancer, since there is no routine blood test that detects it. Treatment Surgery. If endometrial cancer is diagnosed, a woman is referred to a gynecologic oncologist, who specializes in treating cancers of the female reproductive tract. Standard treatment is surgery to remove the uterus, cervix, both ovaries, and the fallopian tubes. This is called a “total hysterectomy and bilateral salpingo-oophorectomy.”

for each woman is determined by her surgeon. Radiation or hormones. If a woman is not a candidate for surgery, treatment options include radiation or hormone treatment with a progesterone-type hormone called progestin. Subsequent treatment. Findings from surgery and imaging allow a woman’s doctors to determine if she needs additional treatment with radiation, chemotherapy, or both. Therapies are sometimes available by participating in clinical trials. After any treatment, women will be asked to schedule frequent follow-ups to detect any recurrence.

This disease has a good cure rate if detected early.

Surgery sometimes includes dissecting lymph nodes to learn whether the cancer has spread to the lymphatic system. If cancer has spread widely throughout the abdomen, surgery may include additional procedures to remove as much visible tumor as possible. Surgery can be done through a large abdominal incision or by laparoscopy. Laparoscopy is a technique that involves making several small abdominal incisions through which specialized surgical instruments and a camera are temporarily placed in the patient’s body. This is considered a minimally invasive procedure and generally allows patients to recover faster than those who have traditional surgery involving a large incision. However, not all patients are candidates for laparoscopy, and the appropriate surgical approach

Staging “Staging” a cancer determines the degree to which it has spread throughout the woman’s body. Knowing what stage a cancer is in is used to guide treatment and to counsel a woman about her prognosis. Endometrial cancer is staged based on the findings from surgery and, sometimes, with the help of imaging procedures that may include MRI, a PET scan, or a CT scan. Stages range from I to IV, with Stage I indicating an early diagnosis and a generally favorable prognosis. This stage applies when the cancer is confined to the uterus. Stage II applies when the cancer has spread to the cervix. Stage III describes cancer that has spread to the vagina, ovaries, fallopian tubes, tissue surrounding the uterus, or Uterine cancer to page 19

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

• Track your blood pressure and share with your doctor • Medicines can make a difference... if you take them • Eat healthy and be active

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INFORMATION Job Number

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MN Health Care News

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Minnesota Diabetes & Heart Health Collaborative

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

www.mn-dc.org Adapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard May/June 2014 MInnESoTA HEALTH CARE nEwS

Calendar Scleroderma Awareness Month

June18

Depression and Bipolar Support Group

The Mental Health Association of Minnesota offers this free support group for anyone affected by depression or bipolar disorder. Come connect with others who understand in a supportive environment. For more information or to sign up, call Mary at (651) 636-4012. Wednesday, June 18, 7–8:30 p.m., St. Paul Jewish Community Center, 1375 St. Paul Ave., St. Paul

Cancer Nutrition Education Class

Join this free information session presented by Park Nicollet to learn about nutrition and dietary recommendations for during and after cancer treatment. Call (952) 993-5700 or visit www.parknicollet.org to register. Thursday, June 19, 4:30–5:30 p.m., Park Nicollet Frauenshuh Cancer Center, Carlson Community Room, 3931 Louisiana Ave. S., St. Louis Park

Huntington’s Disease Support Group

The Huntington’s Disease Society of America hosts this free support group for those affected by Huntington’s. Join others facing similar challenges to gain insight and support. For more information, visit www.hdsa.org/mnchap Saturday, June 21, 10:30 a.m.–noon, Oak Grove Lutheran Church, 7045 Lyndale Ave. S., Richfield

Blood Thinners: Monitoring Your Numbers

The West 7th Community Center hosts this free seminar for patients over 55 who take certain blood thinners and would like to be able to test their INR levels at home. Call (651) 298-5493 for more information or to sign up. Monday, June 23, 10:30–11:30 a.m., West 7th Community Center, 265 Oneida St., St. Paul

An estimated 300,000 Americans suffer from scleroderma, an autoimmune rheumatic disease affecting the body’s connective tissues. While scleroderma is Greek for “hard skin,” subtypes of the disease can damage the lungs, kidneys, and gastrointestinal tract. In the most advanced cases, the disease can cause severe damage and complications for the body’s digestive, respiratory, and circulatory systems. Symptoms include pain; fatigue; joint pain; stiff hands and feet; difficulty swallowing; ulcers on fingers and toes; and discoloration, thickening, and tightness of the skin. Women are four times more likely to develop scleroderma than men, and the disease is most common in people age 25 to 50. The exact cause of scleroderma is unknown, and diagnosis is difficult because symptoms can be similar to those of other diseases. There is no cure for scleroderma, however, treatment is available to manage the symptoms, slow the progression of the disease, and limit damage to the body.

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 May/June 2014

Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter hosts this free support group for those affected by scleroderma to share concerns, information, peer support, and encouragement. Call (952) 926-8848 for more information. Wednesday, June 18, 6–7:30 p.m., Southdale Medical Building, 6545 France Ave. S., Edina

July 8

Pregnancy and Infant Loss Support Group

The Center for Grief, Loss & Transition hosts this free group for parents who have experienced the loss of an infant through miscarriage, stillbirth, or early neonatal loss. For more information, call (612) 863-4370. Tuesday, July 8, 7–8:30 p.m., Abbott Northwestern Hospital, 800 E. 28th St., Minneapolis

Crohn’s and Colitis Pediatric Support Group

The Crohn’s and Colitis Foundation of America invites those with children affected by Crohn’s disease and ulcerative colitis to share stories, gain emotional support, and find answers. No registration required. Call (651) 917-2424 for more information. Saturday, July 12, 9–10 a.m., Crohn’s & Colitis Foundation of America Minnesota Chapter, 2277 Hwy. 36 W., Roseville

14Understanding Eating Disorders

The Emily Program offers this class as an introduction to eating disorders, treatment, and the recovery journey. Families and friends of those affected by eating disorders are encouraged to come address common questions and concerns. No registration required. Call (888) 364-5977 for more information Monday, July 14, 6–8:30 p.m., The Emily Program, 2265 Como Ave., St. Paul

Women’s Cardiac Support Group

Allina Health presents this free support group for women living with heart disease. Come discuss your experiences, strategies for healthy living, challenges, and solutions. Call (612) 775-3074 to RSVP or for more information. Monday, July 14, 6:30–8 p.m., Minneapolis Heart Institute Foundation Building, Dining Room, 920 E. 28th St., Minneapolis

Addiction Busters Support Group

Twin Cities Men’s Center offers this confidential group for anyone struggling with chemical or behavior addiction. Minimum $3 donation requested. Call (612) 822-5892 for more information. Tuesday, July 15, 7:30–9:30 p.m., Twin Cities Men’s Center, 3249 Hennepin Ave. S., Ste. 55, Minneapolis

Uterine cancer from page 17

lymph nodes. Stage IV describes a cancer that has invaded the lining of the bladder or rectum, or has spread to distant organs. Risk factors Excess estrogen. Approximately 80 percent of endometrial cancers are estrogen-responsive, which means their growth is promoted by estrogen. The main risk factor for developing this type of cancer is long-term exposure to excess estrogen, which can be from internal or external sources. Sources of internal estrogen can be associated with a condition called chronic anovulation, obesity, or tumors that secrete estrogen. External sources can include estrogen supplementation that is not combined with progesterone in women who have a uterus.

of menopause is 51), infertility, never having given birth, high blood pressure, diabetes, precancer of the endometrium (hyperplasia), a history of breast or ovarian cancer, pelvic radiation, and taking tamoxifen, a medication used to treat breast cancer. Lower your risk Most cases of endometrial cancer cannot be prevented. However, there are modifiable risk factors, such as maintaining a healthy diet and weight and increasing routine physical activity. Women who take estrogen-containing hormone replacements or are considering them should talk to their doctor about the risks and benefits of this medication and how it affects their risk of endometrial cancer. Women with a high risk of endometrial cancer due to inherited genetic disorders should consider having their uterus and ovaries removed once they are done with childbearing.

Postmenopausal women who notice any vaginal bleeding, no matter how little, should seek prompt medical evaluation, even if the bleeding stops.

Obesity. As obesity increases, so does risk. An obese woman is up to 3.5 times more likely to be diagnosed with uterine cancer than a woman who maintains a healthy weight. A high-fat diet is believed to be a risk factor by leading to obesity and also by affecting the metabolism of estrogen. Other factors. Inherited genetic disorders, such as Lynch syndrome, increase the risk of endometrial cancer as well as other malignancies. Other risk factors include late menopause (average age

And remember: Postmenopausal women who notice any vaginal bleeding, no matter how little, should seek prompt medical evaluation, even if the bleeding stops. Diagnosing endometrial cancer early is key to the best outcome. Annie Tan, MD, PhD, is a gynecologic oncologist who is board-certified in obstetrics, gynecology, and gynecologic oncology, and practices with Minnesota Oncology.

May/June 2014 MInnESOTA HEALTH cArE nEWS

Caregiving

Hospital-to-home transition Multiple resources support patient recovery By Rahul Koranne, MD, MBA, FACP

nce people leave the hospital, they still may require help in order to achieve optimum health and to avoid being readmitted to the hospital. Sources of help fall into three basic categories: health care providers, residential settings, and community-based care. Here’s a look at some of the ways that each of these types of support can help you tailor an individualized hospital-to-home transition that’s right for you.

In the next issue...

• Heat stroke • Painkiller addiction • Accidental bowel leakage

Health care providers Transition coaches Coaches initially meet with patients in the hospital. After a patient leaves the hospital, the coach makes one home visit and three subsequent phone calls to make sure the patient is following the coach’s recommendations. They primarily help patients manage medication, maintain personal health records, and keep follow-up appointments with primary care providers. Coaches also educate patients to recognize conditions that might lead to hospital readmission, and teach patients what to do in such situations. Diagnoses that trigger involvement of a transition coach include COPD, diabetes, hip fracture, and pneumonia. Faith–health nurses Faith nursing blends nursing with ministry, ensuring that people have access to health care and spiritual care simultaneously. These nurses counsel on health-related issues and advance directives; instruct on wellness and achieving mind/body/spirit connection; advocate for families navigating the health care system; provide companionship by visiting people in need; and offer screenings at health fairs. These nurses promote health and well-being through all stages of life and refer patients to appropriate resources. Residential settings Some health systems employ physicians and nurse practitioners to provide health care to residents of transitional care units, nursing homes, and assisted living facilities, as well as to people in their own home. These health care providers offer a review of patients’ medical history and general physical exams; ongoing, regularly scheduled primary care for treatment of conditions ranging from infections and influenza to allergies and arthritis; medication management; pre-surgery assessments; access to specialty providers and facilities when a higher level of care is needed; and coordinated access to palliative and hospice care. Group homes provide a supervised setting for small groups of elderly disabled or developmentally disabled patients. This represents a growing trend, one that provides residents with traditional health

MinneSOTA HeAlTH CAre newS May/June 2014

care services in a home-like setting as an alternative to housing patients in a skilled nursing facility, which is typically more expensive. At home. Among the benefits of receiving medical care at home is that it often can lead to an in-depth assessment of the living environment. This includes pointing out health risks that may exist, such as carpets and wires that could trip the resident and lead to a fall. In-home medical care also is an optimal setting in which to have difficult conversations about such topics as living wills and end-oflife choices. Long-term acute-care hospital (LTACH). The two LTACHs currently in operation in Minnesota provide care for critically ill patients who have highly complex medical needs. This includes people who have been discharged from an intensive care unit but who require specialty care such as ventilator weaning, advanced wound care, brain injury services, and treatment for multiple-organ failure and system failure. Home care, palliative care, hospice care Home care is not only for people physically unable to leave their homes. It’s also available to patients who experience stress when they leave their home to meet medical needs. Beyond providing care such as checking vital signs like blood pressure and changing wound dressings, home care staff also can offer nutrition care; assess living space for safety; provide physical, speech, and occupational therapy; infuse medication; provide care to newborns and their mothers; and provide social work services.

Electronic aids Medication management systems are one type of electronic aid that can help someone maintain his or her health outside a hospital setting. These systems can dispense prescriptions multiple times each day, and are ideal for people who have a complex medication schedule or who have difficulty remembering to take their medication. Home-monitoring systems help individuals live independently by providing a way to access emergency assistance 24/7. Palliative care treats patients who have serious or life-limiting illness. It addresses both physical and emotional symptoms, such as pain, breathlessness, nausea, fatigue, and depression. This type of care can help people process concerns or anxieties; think about goals of care, advance directives, and difficult decision-making; and show patients how to maximize quality of life by managing their symptoms. Palliative care specialists visit patients wherever patients reside. Hospice care is a Medicare benefit for patients who are in their final six months of life, who have decided against treatment of active disease, and who have chosen comfort as their main goal of care. Hospice care provides patients with symptom management and the best possible quality of life wherever the patient resides. This type of care also provides holistic support for the patient’s family. Hospital-to-home transition to page 32

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May/June 2014 MInnesoTA HeALTH CAre news

Caregiving

Coordinating home health care and medical care Avoid pitfalls By Joyce M. Konczyk, LSW, and Anita Raymond, LISW, CMC

our loved one just came home after receiving medical care: now what? it’s important for people to follow medical advice whether it comes in hospital discharge papers, from the clinic nurse who administered a flu shot, or in doctor’s orders to a home health worker.

interact adversely. Plus, receiving advice from multiple sources can cause information overload. this can make it difficult for a person to remember and follow advice accurately, especially patients experiencing cognitive decline or those who are frail and live alone with little or no help.

Unfortunately, receiving advice from multiple sources can present pitfalls. it can lead to a patient being prescribed medications that

the key to avoiding these and other pitfalls of coordinating home health care and ongoing medical care is to appoint an advocate for the patient. the advocate functions as the point person for everyone involved in the patient’s health care. Here’s what to do.

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Minnesota HealtH care news May/June 2014

Steps to take 1. Designate someone to serve as the patient’s advocate. this helps ensure that recommendations made by all of a patient’s health care providers are followed, which requires teamwork between the patient (if possible), the advocate, family members, hospital social worker, physician’s clinic staff, and any home health care staff. an advocate can be a family member, trusted friend, or professional care manager. 2. obtain professional assessment to determine the level of home care needed and to get help choosing a licensed home care agency if one is needed. 3. if you select a home health care agency, you’ll be asked to sign a contract for its services. Before signing, read the contract thoroughly. ask questions about anything with which you do not agree or don’t fully understand. 4. Understand the process for updating the plan of care provided by a home health care agency. Updating might be necessary if, for example, an employee is unsatisfactory or if health care services must be added. 5. communicate all concerns to all members of the care team via an agreed-upon method, such as email. 6. Maintain a written journal of concerns and notes about the patient’s daily functioning. this provides the same useful information to everyone involved in the patient’s care.

Tips for advocates Responsibilities an advocate should attend medical appointments with the patient, and correctly and succinctly report to the doctor the patient’s daily functioning at home. information that the advocate should report includes the patient’s ability to comply with medical recommendations and any ongoing measures being taken to prevent rehospitalization or recurrence of acute problems. this information also should be recorded in the daily journal. it is essential for the advocate to establish and maintain good communication with all members of the patient’s health care and home care teams. the advocate should start by identifying key people in the patient’s doctors’ offices, the home care agency, the hospital, and clinics. Depending on the patient’s ability to remember and accurately report the doctor’s findings, the advocate should inform the home care team what the doctor recommends regarding medication changes, diet, or exercise. Release of Information Because a patient’s medical information is confidential, an advocate should ensure that the patient sign a release of information form. this enables members of the health care team to communicate with each other and with the patient’s family. without this written release from the patient, none of the team members is legally able to disclose any information about the patient, not even to family members, including the patient’s spouse and adult children. the advocate should request a blank release form from each entity that

provides the patient’s health care, make sure the patient completes and signs it, and return each form to the entity that provided it. Is care coordination sufficient? indications that the advocate needs to fine-tune coordination include: • Patient does not remember, understand, or follow a doctor’s recommendation.

Learn about home health care Minnesota Department of Health (651) 201-5000 Find home health care Senior LinkAge Line (800) 333-2433 Care Options Network (952) 945-4065 Minnesota Home Care Association (651) 635-0607 Care Providers of Minnesota (952) 854-2844 National Association of Professional Geriatric Care Managers www.napgcm.org

• Patient does not receive recommended follow-up tests and procedures. • Prescriptions are not being refilled, new prescriptions are not filled, the patient is running out of medications too quickly, or is not needing expected refills.

coordinating home health care and medical care to page 34

Chemical dependency in older adults is hard to recognize We help them live a healthier life Alcohol and drug abuse by seniors often goes unnoticed because of isolation and loneliness. As a result, the older adult continues to suffer in silence. Senior Helping Hands is a program of St. Cloud Hospital Recovery Plus and a recognized national leader providing support and services to stop the suffering. Senior Helping Hands serves individuals age 55 and older. Services • Outreach service and consultation with family or concerned persons • Evaluation and assessment for chemical dependency and/or mental health issues completed by qualified professionals • Volunteer support for older adults who are chemically dependent • Support from peer volunteer counselors for older adults with mental health issues Programs Older Adult Chemical Dependency Primary Treatment Program A comprehensive program that involves physical/psychosocial/chemical use assessments performed by professionals trained in chemical dependency and mental health, including a full time Medical Director who is an addictionist. The program provides a slow pace, holistic approach to recovery. Transportation and temporary housing are available if needed.

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May/June 2014 Minnesota HealtH care news

Antibacterial products Are they healthy? By Johanna Kertesz, MS Editor’s note: On May 16, Gov. Dayton signed a bill making Minnesota the first state to prohibit the use of triclosan in most retail consumer hygiene products. The ban takes effect Jan. 1, 2017.

hat do hand soap, toothpaste, mouthwash, dishwashing liquid, and laundry detergent have to do with your health? if they contain the chemical triclosan, more than you might suspect. triclosan is one of several different antibacterial agents that can be added to products to enhance their bacteria-fighting properties. it is also sometimes added to plastics and textiles to make them resistant to bacterial growth. (“antibacterial” is also referred to as “antimicrobial.”)

and appropriate for personal care products, so you may see it listed among ingredients in dental care products.

Concern the reason for concern about this chemical is that it poses several potential risks to animal and human health. according to the centers for Disease control and Prevention (cDc), people can absorb small amounts of triclosan through the skin or mouth when although triclosan has been used in consumer products for more using products that contain it. a 2004 cDc study detected triclosan in the urine of nearly 75 percent of the people tested. although levels than 30 years, studies demonstrating its effectiveness in reducing found in people are not currenbacteria are not readily available for most products. Fighting gingitly considered hazardous, recent studies have raised concern about vitis (inflammation of the gums) is the only use of triclosan the U.s. the frequent inclusion of triclosan in consumer products. Food and Drug association (FDa) currently recognizes as effective

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Minnesota HealtH care news May/June 2014

Toxic transformation Breakdown products of triclosan are formed because much of the triclosan in consumer products ends up going down the drain, eventually ending up in wastewater treatment plants or septic systems. wastewater treatment only partially removes this chemical, however. chlorine used to treat waste transforms some of the remaining triclosan into chlorinated triclosan derivatives (ctDs). ctDs end up in surface waters such as lakes (or groundwater, in the case of septic systems). when ctDs are exposed to sunlight, a chemical reaction occurs that transforms ctDs into polychlorinated dioxins, a class of chemicals known to be toxic and carcinogenic. Risks the confirmed presence of triclosan in humans, and the discharge of triclosan and its breakdown products into Minnesota lakes and rivers, poses several potential problems. triclosan has been shown to disrupt hormone regulation in animals, it contributes to bacteria’s resistance to antibiotics, and its breakdown products may cause cancer, disrupt hormone systems, or both, in humans. in addition to studies showing triclosan’s unhealthy effects on animals, organisms in the water may be exposed to this chemical and its breakdown products for long periods of time because of triclosan’s continuous release into surface waters. this means it may accumulate in fish. what this may mean for people who eat fish caught in Minnesota waters is not yet known. Addressing the problem in a 2010 study of wastewater treatment plants, the Minnesota Pollution control agency (MPca) and the U.s. Geological survey detected triclosan in 19 of 25 discharge water samples, and in all 24 sediment samples collected downstream from treatment plant discharge. the MPca and the Minnesota Department of Health (MDH) continue to monitor rivers, streams, lakes, and groundwater for

triclosan. at this time, levels found in Minnesota waters have been less than 5 parts per billion (ppb). this is much lower than MDH’s recommendation that drinking water contain 50 ppb or less of triclosan. a recent University of Minnesota study of Minnesota lake sediment layers downstream from wastewater treatment plants found that triclosan, ctDs, and triclosan-derived dioxins have been deposited in increasing amounts from 1963 to the present. the authors concluded that more specific study was needed, but that “because these dioxins are a class of compounds known to be toxic and carcinogenic, their production from triclosan and ctDs is of clear concern.”

do reference cDc guidance that indicates that health care workers don’t need antibacterial soap to properly clean their hands. an alcohol-based hand rub, or non-antibacterial soap followed by an alcohol-based hand rub if hands are visibly soiled, is more effective at reducing bacteria on hands than is antibacterial soap alone.

It may be best for consumers to avoid products that make antibacterial claims.

State, federal response research highlighting triclosan’s problems and its presence in Minnesota waters has prompted the state government to reduce its use of triclosan-containing products. over the last several years, state contracts for cleaning products and dish- and laundry-cleaning compounds have prohibited triclosan. in addition, Gov. Dayton ordered that state agencies could no longer procure such products after June 30, 2013. this order allowed state agencies in certain medical or other settings with a justifiable need for triclosan products to request a waiver from the ban, but no waivers have been received to date. in December 2013, the FDa proposed a rule that would require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled in order to remain on the market. companies must demonstrate safety and effectiveness by mid-2015. Avoid exposure according to the MDH, “there is little evidence that antibacterial soaps are more effective than plain soap for preventing infection under most circumstances in the home or in public places.” Human exposure to triclosan comes mainly through the use of consumer products, and can best be avoided by not using products that contain triclosan or the related chemical triclocarban. to date, the FDa has not received evidence that triclosan in antibacterial soaps and body washes provides more benefit than washing with regular soap and water. see the sidebar for MDH hand-washing MDH hand-washing guidelines guidelines. 1. Wet hands with warm, running water. 2. Add soap. 3. Rub hands vigorously for 20 seconds. Wash all surfaces, including: • Backs of hands, • Wrists, • Between fingers, • Tips of fingers, and • Thumbs under fingernails, preferably with a nailbrush. 4. Rinse. Keep fingers pointed down. 5. Dry vigorously with paper or clean cloth towel. 6. Turn off faucet with towel and open door with towel.

Health care and food-handling settings are unique in their exposure to higher levels of bacteria and deserve special attention. MDH hand-washing guidelines for food handlers do not specify the use of antimicrobial soap. rather, the Minnesota food code fact sheet specifies the use of soap and the mechanical action of scrubbing hands. MDH hand-washing guidelines for health care professionals are less descriptive, but

although the use of antibacterial soap in health care settings is common, some health care organizations recognize the products’ problems. california-based hospital system Kaiser Permanente phased out its use of triclosan-containing soaps in 2010. “… where there is credible evidence that a material we’re using may result in environmental or public health harm, we strive to replace it with safer alternatives,” said Kathy Gerwig, environmental stewardship officer at Kaiser Permanente, before the U.s. senate in 2009. What you can do the american Medical association and the cDc both recommend that consumers use soap that does not contain antibacterial agents such as triclosan. although there is not yet guidance on selection of other triclosan-containing products, such as plastics or textiles, evidence for unintended, yet harmful consequences of triclosan is mounting. Until research demonstrates that triclosan is both effective for a given product and is safe for humans and the environment, it may be best for consumers to avoid products that make antibacterial claims. Johanna Kertesz, MS, coordinates the State of Minnesota’s Environmentally Preferable Purchasing program at the Minnesota Pollution Control Agency. She works to reduce the environmental and human health impact of government procurement.

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May/June 2014 Minnesota HealtH care news

Genetics

New drug therapies Custom-tailored health care By Ken Dornfeld, MD, PhD, and Catherine A. McCarty, PhD, MPH

hat if your response to medication could be maximized, while simultaneously minimizing or avoiding side effects?

that’s the promise of pharmacogenetics. this field, sometimes called “personalized medicine,” is the study of how a person’s unique genetic composition influences that person’s response to med-

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the ultimate goal of this field of study is to use genetic information to increase medical therapy’s efficacy and avoid side effects. it is also being used to discover new targets for drug therapy. Current understanding the pharmacogenetics of some medicines is already known, and the Food and Drug administration (FDa) maintains a list of approved drugs that have pharmacogenetic information in their labeling. More than 150 drugs currently have this labeling, including the commonly prescribed medicines warfarin and tamoxifen. Most of these labeled drugs may have side effects that are more toxic in people with certain genetic variations.

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ications. For example, people with certain genetic variations experience increased toxicity from the side effects of some drugs. other genetic variations decrease a person’s response to the same drugs.

the reason that most drugs vary in their degree of toxicity stems from how they are broken down inside the body (metabolized) by metabolic enzymes. if a drug is metabolized slowly, it stays in the body longer than one that is metabolized quickly. the longer medicine stays in the body the more it accumulates, thus reaching higher, potentially toxic, levels before the body excretes it. in contrast, if the same drug is metabolized by a faster-acting enzyme, it may be excreted by the body before it reaches a level that allows it to be maximally effective and before it accumulates to potentially toxic levels. what makes someone have one variant of an enzyme, and someone else have a different variant of the same enzyme? the answer lies in their genes: Genes direct the body to make enzymes. since people are not identical (even identical twins differ genetically), the gene directing production of a given enzyme is not the same in everyone. whether someone has an enzyme that metabolizes a drug quickly or a variant of that enzyme that metabolizes a drug slowly is determined by which variant they have of the gene that directs the body to make that enzyme.

Genetic variation in action For example, there is an enzyme that converts the breast cancer medicine tamoxifen into a more active form of that drug. However, some people have a genetic variation that gives them a less-active enzyme that decreases tamoxifen activity. whether breast cancer patients who have the less-active enzyme have worse outcomes from tamoxifen is currently under investigation.

vember 2013 suspension is whether Dna sequencing is a medical test subject to FDa control or simply a source of personal information, which is not FDa-regulated.

A person’s unique genetic composition influences that person’s response to medications.

Current applications Just as there are genetic variations among people, there is genetic variation between normal tissue and cancerous tissue. this can be detected by comparing Dna from a person’s normal tissue with Dna from the same individual’s cancerous tissue, in order to detect unique genetic changes in the cancer. For example, approximately 20 percent of breast cancers contain an overabundance of the abnormal gene called Her2, which promotes excess cell growth that leads to cancer. this gene was used to develop the drug Herceptin (trastuzumab), which blocks this gene’s growth-promoting action. standard medical practice is to test every breast cancer diagnosed to determine if its cells contain Her2. if they do, the patient is advised to take Herceptin. similarly targeted therapy can be used against the growth-promoting genes sometimes involved in colon cancer. treatment targeting gene variants is available for diseases other than cancer. this includes a drug developed to treat a subset of cystic fibrosis in patients who have a specific genetic variant responsible for this disease. How can we determine whether someone has a given gene variant? one powerful tool is a test called “Dna sequencing.” DNA sequencing this test determines the order, or sequence, in which the body’s building blocks that make up Dna are arranged. some companies have offered Dna sequencing services directly to the public; genes sequenced include those responsible for some genetic disorders as well as genes involved in drug metabolism. one company, called 23 and Me, offered these sequencing services and has been ordered by the FDa to suspend its testing. the issue forcing the company’s no-

The future while regulation is evolving, so is the efficiency of Dna sequencing, which continues to accelerate. eventually, it will be possible to Family health history An online tool to create a family health history is at My Family Health Portrait (www.hhs.gov/familyhistory/).

New drug therapies to page 31

Telephone Equipment Distribution (TED) Program

another drug metabolized by enzymes is warfarin, which prevents blood from clotting. if someone has an enzyme variant that inactivates this drug slowly, warfarin accumulates in his or her body. thus warfarin levels become too high, and the risk of excessive bleeding is high. on the other hand, in someone who has an enzyme variant that inactivates the drug quickly, warfarin levels become too low. thus the risk of excessive clotting is high, which can cause strokes and heart attacks. Genetic tests can determine if an individual is likely to inactivate warfarin quickly or slowly, and these test results are used to help determine the correct dose.

this case is ongoing, and underscores the need for new approaches to manage genetic data. the Genetics information nondiscriminatory act (Gina) of 2008 prohibits health insurance and employment discrimination based on genetic information. However, as the 23 and Me case illustrates, regulation continues to evolve.

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May/June 2014 Minnesota HealtH care news

OpthalmOlOgy

Statins and cataracts New research suggests a link By Y. Ralph Chu, MD

tatins are a class of drugs commonly used to lower cholesterol levels, cataracts are the leading cause of vision loss in the U.S., and recently, researchers found a connection between the two. Hereâ&#x20AC;&#x2122;s information to help you understand the connection.

Read us online Wherever you are!

Cataracts According to the federal Centers for Disease Control and Prevention, more than 20.5 million Americans have cataracts. In someone who has this condition, protein in the lens inside the eye breaks down, causing the eyeâ&#x20AC;&#x2122;s lens to become cloudy. Common symptoms include difficulty seeing colors and changes in contrast; difficulty driving, reading, and recognizing faces; and difficulty coping with glare from bright lights. Cataracts usually affect one eye first, but gradually affect both eyes. Several factors have been shown to cause them, including longterm exposure to ultraviolet light and exposure to ionizing radiation. Overall health also plays a role, since conditions such as diabetes, hypertension, advanced age, and trauma can result in breakdown of the lens protein. Statins It is estimated that one in four Americans over age 45 currently takes a statin. In November 2013, the American College of Cardiology and the American Heart Association jointly announced new treatment guidelines for high cholesterol that likely will double the number of statin users. Such a significant increase in statin use makes it even more important to understand the reported link between statin use and cataracts.

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MINNeSOTA HeALTH CARe NewS May/June 2014

Finding a connection In one of the largest studies ever done on the subject, results published in the November 2013 issue of JAMA Ophthalmology demonstrate a connection between statin use and cataracts. Jessica Leuschen, MD, of the San Antonio Military Medical Center, Texas, and colleagues compared the risk of developing cataracts between statin users and non-users who were closely matched in other ways, such as gender and other medical conditions. Results showed that

statin users had a 27 percent greater risk of developing cataracts than non-users.

cussing it with your doctor. Ask your doctor about risks associated with any medications you take.

Further analysis found that this risk may be even higher in statin users who have risk factors for cardiovascular disease but who have not yet experienced any cardiovascular disease events such as a heart attack or stroke. The study concluded that there was a connection between statins and cataracts, but did not show that statin use caused cataracts. Be aware Statins are not the only medication associated with cataract development.

Anyone who uses statins should discuss the statin-cataract association with his or her doctor.

Medications directly associated: Oral steroids. Researchers have found a direct connection between the risk of developing cataracts and long-term use of oral steroids, medication often prescribed to suppress inflammatory conditions such as rheumatoid arthritis. Other medications associated with cataract development but for which a definitive connection has not been proven include: Glaucoma medications, used to treat a condition in which pressure inside the eye causes gradual loss of vision Psoralens, a class of drugs used with light therapy to treat certain skin disorders such as psoriasis Antipsychotic medications such as chlorpromazine (Thorazine), used to treat mental disorders, severe behavior disorders, severe hiccups, severe nausea and vomiting, and certain types of porphyria, a metabolic abnormality Medications weakly associated with cataracts but for which a definitive connection has not been proven include:

Treating cataracts It’s also important to remember that even though cataracts may develop as the result of using life-saving medication, they are treatable. In fact, the National Institutes of Health says that procedures to remove cataracts are among the most common and safest surgeries performed in the U.S. This surgery removes the old, clouded lens from the eye and replaces it with a new, artificial one to restore the patient’s vision.

Cataract surgery is an outpatient procedure that requires a few hours and uses a topical anesthetic. Standard procedure involves the surgeon making a tiny incision in the eye with a manually controlled tool. Through this incision, the surgeon inserts a tool about the size of a pen tip. This instrument breaks the cloudy lens into pieces and is used to remove the pieces from the eye. Once the cataract is Statins and cataracts to page 30

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Allopurinol, used to treat gout and some kinds of kidney stones Tamoxifen, used to treat advanced breast cancer in men and women and early breast cancer in women Amiodarone, prescribed for some life-threatening heart rhythm problems (arrhythmias) Tricyclic antidepressants, used to treat depression Potassium-sparing diuretics (but not other types of diuretics) used to treat high blood pressure and congestive heart failure

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Don’t overreact Despite the association between certain medications and cataract development, it’s important to remember that many of these drugs can save lives. Statins, for example, are an effective treatment for lowering cholesterol and help reduce risk of cardiovascular disease. In some cases, statins can prevent a heart attack or stroke.

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Statins and cataracts from page 29

removed, an artificial replacement lens is inserted through the same tiny incision. A newer procedure uses the Victus femtosecond laser, which is approved by the Food and Drug Administration for cataract surgery. Using this laser allows surgeons greater precision than the standard manual cataract-removal technique. Weigh risks, benefits Anyone who uses statins should discuss the statin-cataract association with his or her doctor to weigh the risks and benefits of statin use. Doctors also can discuss ways to manage cholesterol levels through lifestyle changes, which potentially could allow a patient to avoid statins and their associated side effects altogether. y. Ralph Chu, mD, is medical director of Chu Vision Institute, Bloomington, and an adjunct associate professor of ophthalmology at the University of Minnesota Medical School.

Protect your eyes There is no way to prevent cataracts, but there are ways to delay their onset. Schedule regular eye exams according to your age, to detect and treat problems early. Children should have their first eye exam at 6 months of age, at age 3, again before the start of school, and every two years thereafter until age 18. Children or teens who wear eyeglasses or contact lenses should have their eyes checked every year. Adults ages 18 to 60 need to have their eyes checked every two years, or every year for those wearing contacts or glasses. Adults ages 61 and older should have their eyes checked every year. • Wear sunglasses (preferably wraparound) and a hat to protect your eyes from the sun. Be sure to wear protective eyewear when working with chemicals or dangerous machinery, or when engaging in sports like skiing, snowmobiling, hockey, basketball, and racquetball. • Eat for eye health. Vitamins and minerals in fruits, vegetables, and fish may help eyes age more slowly. • Stop smoking. • Talk to your doctor if you have a chronic health condition such as diabetes or thyroid disease, which may increase your chance of developing cataracts.

WHO’S A BIGGER BASEBALL FAN, YOU OR ME? You’ll find that people with Down syndrome have a passion for knowledge and learning that can rival anyone you’ve met before. To learn more about the rewards of knowing or raising someone with Down syndrome, contact your local Down syndrome organization. Or visit www.dsamn.org today. It is the mission of the Down Syndrome Association of Minnesota to provide information, resources and support to individuals with Down syndrome, their families and their communities. We offer a wide range of services, programs and materials at no charge. If you are interested in receiving one of our information packets for new or expectant parents, please email Kathleen@dsamn.org or For more information please call:

(651) 603-0720 • (800) 511-3696

MINNeSOTA HeALTH CARe NewS May/June 2014

New drug therapies from page 27

sequence all of a person’s DNA (e.g., someone’s complete genetic information) in a single test. From the standpoint of improving medical care this will be a major development, because it means that a single test will be able to predict an individual’s response to a variety of drugs. The hope of personalized medicine is to use this personal sequence information to increase the specificity and effectiveness of disease treatment. Once that hope becomes reality, it may be as routine to include someone’s complete genetic information in his or her medical record as it currently is to include blood type. However, until genetic-based drug therapy becomes standard practice and is readily available, clinicians will continue to use detailed family health histories to personalize health care. A family health history is most useful when it includes the names of three generations of biological relatives and

indicates how they are related. Firstdegree relatives include parents, children, brothers, sisters, and halfsiblings, who should be identified as such. Second-degree relatives include aunts, uncles, nieces, nephews, grandparents, and grandchildren. Thirddegree relatives are first cousins. This history also should include each person’s age when diagnosed with any medical conditions they have or had, the age at death of deceased relatives, and the cause of death if known. Taking the time to write a family health history will help ensure that the health care you receive is custom-tailored. Ken Dornfeld, MD, PhD, is a radiation

oncologist at Essentia Health–Duluth. His research interests include laboratory investigation of interactions between drugs and radiation, as well as clinical research in breast cancer. Catherine A. McCarty, PhD, MPH, is a scientist at Essentia Institute of Rural Health, Duluth. She is conducting genomic medicine and family health history studies funded by the National Institutes of Health.

For more information To stay informed about this rapidly developing field, visit the following reputable websites. • National Human Genome Research Institute, National Institutes of Health (NIH). Information for patients, researchers, and clinicians. www.genome.gov • Centers for Disease Control and Prevention Office of Public Health Genomics. Information about the effective and responsible translation of genomics research into population health benefits. www.cdc.gov/genomics/ • Food and Drug Administration. Genomics information as well as a table of approved drugs that provide pharmacogenomic information in their labeling. www.fda.gov/Drugs/ScienceResearch/ ResearchAreas/Pharmacogenetics/default.htm • National Society of Genetic Counselors. Information about finding genetic counselors and the services they provide. www.nsgc.org • American Cancer Society. Information about genetic causes of, and gene-based therapies for, cancers. www.cancer.org • American Heart Association. Information about the genetic basis of heart disease and treatment. www.heart.org • Genetic Alliance. This nonprofit health advocacy organization offers free brochures on various genetics topics. www.geneticalliance.org

Orthopaedic

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Monday - Friday 1:00 p.m. to 8:00 p.m. Saturday & Sunday 8:00 a.m. to noon • No appointment is necessary • All patients are seen by a physician

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Hospital-to-home transition from page 21

Community-based care Care coordinated between multiple community resources manages patients’ care no matter where they live, whether in their own or an adult child’s home, assisted living facility, nursing home, or elsewhere. Care can range from providing home modifications such as grab bars in the tub, to adult daycare programs, to transportation, to behavioral health services. Minnesota Senior Health Options (MSHO) is one example of community-based care. Under MSHO, seniors who are eligible for both Medicare and Medicaid can enroll in different health plans but work with care managers, social workers, and case aides to develop an individualized plan of care that establishes and maintains services they need for maximum health, functional outcomes, and independence.

St. Paul residents age 50 and older healthy, active, and involved in their community. This free program offers social events, health screenings, classes, and workshops to help minimize loneliness, depression, stress, and isolation. Many resources Minnesotans are lucky to have a wide array of health-promoting resources available to help them optimize their health after they leave the hospital. Choosing from this array is typically driven by individual preference, clinical need, case manager judgment, and insurance coverage. These resources can be used individually or in tandem, whatever makes the most sense for the individual. Because, although all of us have individual health goals, achieving optimum health and avoiding hospital readmission makes sense for everyone.

Minnesotans are lucky to have a wide array of health-promoting resources.

Social connections—feeling integrated into your community—have been shown to support good health. One example of an initiative that fosters such connections is Passport, a collaboration between HealthEast and the City of St. Paul. Passport aims to keep

Rahul Koranne, MD, MBA, FACP, is board-certified in internal medicine

and geriatrics, and is the vice president for community services at HealthEast Care System and the executive medical director of Bethesda Hospital, St. Paul.

Minnesota

Health Care Consumer Association

April survey results ...

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 the results of the April survey.

50 40 30 20 10 0

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

80 70 60 50 40 30 20 10 0

Strongly agree

Agree

No opinion

Disagree

40 30 20 10 0

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

5. E-liquids should be required by law to be sold in childproof containers.

Percentage of total responses

4. Ingredients should be required by law to be listed on containers of e-liquid.

Strongly disagree

MinnESOTa HEalTH CarE nEwS May/June 2014

80 70 60 50 40 30 20 10 0

3. E-cigarettes should be banned from use in public places.

Percentage of total responses

2. E-cigarettes and e-liquid should be labeled with health warnings similar to those required for tobacco products.

Percentage of total responses

1. E-cigarettes and e-liquid (the substance vaporized in e-cigarettes) should not be sold to minors.

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

30 25 20 15 10 5 0

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

Minnesota

Health Care Consumer Association

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

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

www.mnhcca.org

Join now.

â&#x20AC;&#x153;A way for you to make a differenceâ&#x20AC;? May/June 2014 Minnesota HealtH care news SEPTEMBER 2013 MINNESOTA HEALTH CARE NEWS

33 33

daily living such as bathing, eating, and taking medicine. However, patients with financial means can purchase these services from private individuals or licensed home care agencies. Lower-income patients may qualify for help through their county’s Elderly Waiver program; find out about this program at Senior LinkAge Line (see sidebar on page 27).

Coordinating home health care and medical care from page 23

• Repeated acute illness necessitates repeated hospitalizations. • Physician is unaware of patient’s other medical providers. This can result in medications being prescribed without the physician knowing about other medications the patient is taking. This can lead to overdoses or adverse medication interaction. • Patient does not allow scheduled therapists to enter the home because the patient doesn’t recall that the physician recommended therapy or that therapy was scheduled.

Advocates make it easier Without an advocate to coordinate the medical team, home care agency, and family caregivers, a patient’s ability to recover from illness or medical procedures, or to continue living in their own home, can be severely compromised. This can result in slower recovery, faster health decline, repeat hospitalizations, or even worse outcomes.

Designate someone to serve as the patient’s advocate.

Paying for home health care Medicare and private health insurance may pay for skilled care ordered by a physician who certifies the patient’s medical need and homebound status. Skilled care may include visits for wound care; diabetes education and monitoring; in-home lab work; medication management; and physical, occupational, and speech therapy. Medicare and private health insurance do not pay for ongoing custodial care that includes assisting patients with activities of

Appointing an advocate to coordinate all the participants in your loved one’s medical care lessens those risks and will help everyone rest easier. Joyce M. Konczyk, LSW, and Anita Raymond, LISW, CMC, are geriatric care managers in the Care Management and Consultation program at Volunteers of America–Minnesota.

Now accepting new patients

A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures. Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.

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

are interested in learning how to prevent one, we can design a set of just-for-you solutions. Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions

To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com

MinnESoTA HEALTH CARE nEWS May/June 2014

S:9.75”

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

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

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) — Add-on to Glimepiride Victoza® + Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8

mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ® All Victoza + Placebo + Glimepiride Rosiglitazone + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride ® Victoza 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone ® + Metformin + Placebo + Metformin + Rosiglitazone All Victoza Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 Table 3: Adverse Reactions reported in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested

Victoza —a force for change in type 2 diabetes. A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks. Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a

A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.

The change begins at VictozaPro.com. Indications and Usage

Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin.

Important Safety Information

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors. Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials. Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients. There is limited data in patients with renal or hepatic impairment. In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%). Please see brief summary of Prescribing Information on adjacent page. 1013-00018617-1

December 2013