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June 2015 • Volume 13 Number 6

The Minnesota Poison Center Kirk Hughes

Well-Woman Exams Jon S. Nielsen, MD, FACOG

Reproductive Medicine Colleen Casey, MD


L ife. We help people get back to it! Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the Minneapolis/St. Paul area.

To make a referral or for more information, call us at (866) GSS-CARE or visit www.good-sam.com/minnesota.

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. Š 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G0933


June 2015 • Volume 13 Number 6

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News

PEOPLE

PERSPECTIVE Leah Driscoll

10 QUESTIONS Colleen Casey, MD Center for Reproductive Medicine

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The Minnesota Poison Center By Kirk Hughes, RN, EMT, CSPI

18 26

Research

 he Brain Health T Registry By Michael Weiner, MD

28 30

Chiropractic

Torque Release Therapy By Tye Moe, DC

FORTy-FOURTH SESSION

Allied Professions

Unionizing Home Health Care By Sumer Spika

WOmen’s Health Well-Women Exams By Jon S. Nielsen, MD, FACOG

Behavioral Health

 ental illness and M our youth By Todd Archbold, LSW, MBA

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MINNESOTA HEALTH CARE ROUNDTABLE

cALENDAR

Wilder Foundation

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public health

2015 Community Caregivers

Making a difference in Minnesota and the World By Lisa McGowan

Behavioral Health Homes A new pathway to care

Thursday, November 12, 2015 • 1:00-4:00 PM Downtown Minneapolis Hilton and Towers Background and Focus: Increasing evidence supports the link between access to mental health care and reducing health care costs. Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider. Many initiatives nationwide are addressing this issue. It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015. Some states, including Minnesota, are also creating Behavioral Health Home programs. Objectives: We will review numerous initiatives that support the development of the Behavioral Health Home. We will define this term and discuss how to incorporate it into our health care delivery system. We will examine the value it can bring and the challenges it will face. Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring. Panelists include: • L. Read Sulik, MD, PrairieCare Sponsors include: • PrairieCare Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable.

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Associate Editor Richard Ericson | rericson@mppub.com Art Director Joe Pfahl | joe@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com Account Executive Stacey Bush | sbush@mppub.com 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

MDH Launches Plan to Reduce Infant Mortality Rates The Minnesota Department of Health (MDH) has announced a plan to lower the state’s infant mortality rate that will focus on reducing disparities across racial and ethnic groups. Minnesota’s infant mortality rate was the eighth lowest in the nation from 2008 to 2012, the period most recently documented, at 4.9 deaths before age 1 per 1,000 live births. However, overall, the U.S. ranks 27th among industrialized countries. And Minnesota’s rate is about twice as high as some of those countries—Japan has a rate of 2.3 per 1,000 and Sweden has a rate of 2.5 per 1,000. MDH will focus the plan on addressing disparities because it found that white babies in Minnesota have an infant mortality rate of 4.3 per 1,000, while

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African American babies have a rate of 9.2 per 1,000 and American Indians have a rate of 9.1 per 1,000. The leading causes of death also differed between the groups. Across the state, the main cause of infant death in the state is congenital anomalies. It is also the main cause of infant death among Asians, Hispanics, and whites. But for African American babies, the main cause of death is premature birth. And for American Indian babies, the main cause is sudden unexpected infant death (SUID), which includes deaths related to unsafe sleeping practices. “Minnesota has some of the lowest infant mortality rates in the country, but it is not acceptable that American Indian and African American infants are dying at twice the rate of white infants,” said Ed Ehlinger, MD, Minnesota commissioner of health. “This plan underscores that, if we are to improve overall infant survival, we must

Minnesota Health care news June 2015

do more to address the social and economic factors impacting infant mortality in Minnesota.” Risk factors for prematurity include many socioeconomic factors, such as inadequate prenatal health care, exposure to certain environmental pollutants, long working hours, and lack of support. In addition, research has shown that low-income mothers are less likely to have been made aware of safe sleeping guidelines for their infants, which increases the risk of SUID. Another risk factor for SUID is smoking during pregnancy, and smoking is more common among American Indian women than women of other groups. “To deal with health equity, we have to have a conversation about what creates health,” said Ehlinger. “We have to change the notion that health is just about medical care and just about personal choices,

like exercising and eating well and not using drugs. We have to realize that social-economic circumstances impact health.”

Task Force to Determine Future of MNsure The Minnesota Legislature has approved a health and human services bill that includes $500,000 for a 29-person task force to determine options for the future of MNsure as well as MinnesotaCare, including the possibility of combining them. The Minnesota Senate and House, and Gov. Dayton, will appoint members of the task force. They are required to have a report ready for the Legislature by Jan. 15, 2016. The bill does not include more extreme changes some legislators hoped for, such as a proposal to eliminate MNsure in 2017 and a proposal to treat


MNsure more like a state government agency. In addition to the task force, the approved bill includes a proposal to seek a federal waiver to let eligible Minnesotans receive federal tax credits directly through insurers as well as through MNsure, which is currently the only way people can receive these subsidies. MNsure will also now be required to release rates for its insurance plan premiums a minimum of one month before open enrollment begins.

Respiratory Illnesses Most Distinctive Cause of Death in Minnesota The most distinctive cause of death in Minnesota is respiratory illnesses, according to a new report from the U.S. Centers for Disease Control and Prevention (CDC). This means it is the cause of death that has the most elevated impact on mortality in Minnesota compared to the national average. Researchers analyzed deaths in each state from 2001 to 2010 using data from the CDC’s National Center for Chronic Disease Prevention and Health Promotion, to determine which cause of death out of 113 was the most distinctive to each state. They also classified underlying causes of death, taking into account secondary causes that may impact a main cause of death. “Other and unspecified acute lower respiratory infections,” according to the report, was the most distinctive cause in Minnesota and its neighboring states of Wisconsin and Iowa, as well as Kansas, Nebraska, and Ohio. Minnesota’s other neighbors, North Dakota and South Dakota, had pneumonia, also a lower respiratory infection, as its most distinctive cause of death. Researchers developed the map in response to a 2014 social media trend that had users

creating their own maps of the most distinctive or characteristic value of some variable at the state or county level. They wanted to create a map that had a “more nuanced view of mortality variation within the United States than what can be seen by using only the ten most common causes of death.”

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The authors note that the map has its limitations, such as the fact that some of the states’ distinctive causes of death are still very rare—fewer than 100 for 22 states. In addition, there is only one distinctive cause of death noted per state, but there were others that were significantly higher than national averages that are not shown on the map. According to the authors, “Although chronic disease prevention efforts should con­ tinue to emphasize the most common conditions, an outlier map such as this one should also be of interest to public health professionals, particularly insofar as it highlights non­ standard cause of death certifi­cation practices within and between states that can potentially be addressed through education and training.”

New Wound Center Opens in Waconia Ridgeview Medical Center has opened its new Wound & Hyperbaric Healing Center in Waconia. It features two hyperbaric oxygen chambers that surround patients with pure oxygen at increased atmospheric pressure to promote healing, including the growth of new small blood vessels and skin, and fighting infections. “We are pleased to expand our wound care services and bring improved local access to nationally recognized, best-practice wound care protocols to our patients and communities,” said Mike Phelps, MBA, COO of Ridgeview Medical Center. “The addition of two hyberbaric News to page 6

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

Care Beyond Cost.

June 2015 Minnesota Health care news

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News from page 5

oxygen therapy chambers—in Waconia—is especially exciting for patients who previously had to travel up to 30 miles or more to receive these services.” According to Ridgeview, this will benefit patients seeking care for diabetic and pressure ulcers, infections, radiation injuries, and patients with compromised skin grafts or wounds that have not healed within 30 days. “Ridgeview also greatly appreciates the philanthropic support of the Waconia Rotary, which generously donated $5,000 to help fund the purchase of our hyperbaric chambers,” said Phelps. The center is partnered with Healogics, which provides wound care and consulting services to almost 800 hospitals across the U.S.

Deaths Due to Opiates Drops Significantly in Hennepin County Hennepin County saw a 22.7 percent drop in deaths due to heroin and prescription opiates last year, from 132 deaths in 2013 to 102 in 2014, according to the Drug Abuse Trends report from Drug Abuse Dialogues. By contrast, Ramsey County saw a 13.5 percent increase in these deaths, from 37 in 2013 to 42 in 2014. Some officials attribute the difference between the counties to legislation passed in 2014 allowing the use of naloxone, the antidote to opioid overdose, to be made more available to law enforcement and citizens. However, the report’s authors write that, “The extent to which this may have contributed to the decline in opioid-related deaths in Hennepin County is unknown.”

Hennepin County Sheriff Rich Stanek was the first to allow law enforcement officers to carry the naloxone, while the Ramsey County sheriff chose not to allow it. Both were supporters of expanding access to the antioverdose drug. “After consulting with our medical emergency and fire department partners, who share the responsibility of providing services to our patrol areas, we feel confident that their response is the best means to render aid to individuals suffering from a heroin overdose,” the Ramsey County Sheriff’s Office said in a statement. Only one case of overdose reversal due to the administration of naloxone by a deputy has been confirmed in Hennepin County. Deaths due to cocaine fell from 28 to 12 in Hennepin County and from 9 to 5 in Ramsey County. Deaths due to methamphetamines fell from 16 to 11 in Hennepin County and

from 8 to 6 in Ramsey County. However, treatment admissions related to methamphetamine use have been rising in the Twin Cities since 2009 when they accounted for 5.7 percent of all treatment admissions. They accounted for 10 percent of total treatment admissions in 2013 and 11.8 percent in 2014, making it higher now than it was at the height of the statewide methamphetamine epidemic in 2005. In addition, the report notes that methamphetamine seizures by law enforcement increased significantly last year. In Ramsey County alone, law enforcement officers seized 58,286 grams in 2014, compared to 7,239 grams in 2013. “The big take-home message here is that meth is back with a resurgence, and heroin and painkillers still retain their grip,” said Carol Falkowski, CEO of Drug Abuse Dialogues.

Choose well New choices in health care are here. Introducing UCare ChoicesSM, affordable new health plans from a leader in Minnesota health care, with coverage for young adults, families, empty nesters and everyone in between. Find out more at UCareChoices.org, and look for us on the MNsure health insurance marketplace and choose UCare Choices.

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Minnesota Health care news June 2015

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People Mark Mellstrom, MD, board-certified in family medicine, has joined FamilyHealth Medical Clinic’s Family Medicine practice. Mellstrom spent the past 14 years with an independent practice in Lakeville. Prior to that, he practiced for 14 years with an independent group in Northfield and one year with Park Nicollet. He earned his medical degree from ColumMark Mellstrom, bia University College of Physicians and Surgeons MD in New York City and completed a family medicine residency at the Mayo School of Graduate Medical Education.

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Partner perfect plan to h t l a e H Turn to p you find the get. d el let us h needs and bu r u meet yo

Timothy Ehle, MD, board-certified in internal medicine, critical care medicine, and pulmonary disease, has joined the CentraCare Clinic–River Campus pulmonary medicine department. Ehle has a special interest in asthma, COPD, and lung cancer. He earned his medical degree at Michigan State University, College of Human Medicine in East LanTimothy Ehle, sing and completed an internal medicine residency MD and pulmonary/critical care medicine fellowship at Mayo School of Graduate Medical Education. Ramin Artang, MD, board-certified in internal medicine and cardiovascular disease, has joined the Essentia Health St. Mary’s–Heart & Vascular Center in Duluth. He has a special interest in echocardiography and other cardiac imaging and does research on monitoring new anti-clotting drugs. Artang earned his medical degree from the University of Copenhagen School of Medicine in Copenhagen, Ramin Artang, MD Denmark. He completed a residency in internal medicine at the Marshfield Clinic in Marshfield, Wisconsin, and a fellowship in cardiovascular disease at the Medical College of Wisconsin in Milwaukee. Felix Blanco, MD, board-certified in general surgery, has joined Glacial Ridge Health System in Glenwood, Minn. Blanco earned his medical degree at the Higher University of San Andres in La Paz, Bolivia. He completed a general surgery residency at Howard University Hospital and a clinical research fellowship in pediatric surgery at the Children’s Felix Blanco, MD National Medical Center, both in Washington, D.C. Blanco moved to Minnesota in 2013 for abdominal transplant surgery training during his fellowship at the University of Minnesota Medical Center. Keith Peterson, MD, board-certified in internal medicine, pediatrics, and hospice and palliative medicine, has joined Essentia Health–­​St. Mary’s Hospice Services. He will care for patients with the East Range Hospice team in Virginia, the Itasca Hospice team in Grand Rapids, and the hospice team in Duluth. Peterson previously served as a primary care physician at Essentia Health–Ely Clinic and most recently at Essentia Health–Virginia Clinic. He earned his medical degree from the University of Minnesota Medical School, where he also completed a residency in internal medicine and pediatrics.

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www.radiantresearch.com June 2015 Minnesota Health care news

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Perspective

Food Deserts A new urban blight

T

he Twin Cities metro area ranks high on many national “Top” lists—clean air and water, good schools, and high literacy, for example. Unfortunately, it also ranks high on another list: It’s been named the nation’s fifthlargest urban “food desert.”

Leah Driscoll

Twin Cities Mobile Market Leah Driscoll is program manager of the Twin Cities Mobile Market at the Amherst H. Wilder Foundation, a nonprofit health and human service organization that assists thousands of people each year through direct service programs, research, and community development. Established in 1906, the mission of the Wilder Foundation is to promote the social welfare of people in the St. Paul and greater east metropolitan area without regard to nationality, sex, color, religion, or prejudice.

A food desert is typically defined as any area where a grocery store is more than one mile away from people’s homes. The Twin Cities include a large number of neighborhoods where there is limited access to fresh, healthy food, with only convenience stores as an alternative. At last count, over 250,000 residents in St. Paul and Minneapolis are low-income and live in a food desert.

During this process, we heard stories from community members riding the bus an hour or more each way just to get to the nearest grocery store. Older adults said the trek was nearly impossible during the winter months due to the cold and icy sidewalks. Single parents said feeding their children fresh, healthy produce was nearly unaffordable.

Over 250,000 residents in St. Paul and Minneapolis… live in a food desert.

Coming in behind New Orleans, Chicago, Atlanta, and Memphis, the Twin Cities’ food deserts reflect growing health inequities among low-income residents and people of color. A large body of research shows that living in a food desert directly correlates with increased rates of obesity, diabetes, other diet-related diseases, and earlier death. In addition to living in a food desert, other factors—such as lack of transportation, disability, language barriers, and income status—can hamper the ability of individuals to access healthy, affordable food. Intent on curbing these trends and shrinking the Twin Cities’ deserts, the Amherst H. Wilder Foundation’s Twin Cities Mobile Market follows a two-pronged approach: Bring fresh food to neighborhoods with limited resources, and make prices affordable. Using a converted, retired Metro Transit bus, the Twin Cities Mobile Market is a grocery store on wheels, complete with coolers, a freezer, and produce shelves. It stops weekly at 18 different locations to sell a variety of fresh fruit, vegetables, meat, dairy items, and basic dry goods—all at below-market prices. These 18 locations—which include public

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housing high-rises, senior housing sites, schools, community centers, and faith communities—were selected based on food access data and input from over 500 community members. The Wilder Foundation asked community members when and where they wanted the Mobile Market to operate as well as what foods were most in need, and based routes and inventory on this information.

Minnesota Health care news June 2015

In its first month of operation in December 2014, the Mobile Market served over 1,000 individuals, and continues to build toward its goal of increasing access to healthy, affordable food for all. Families and individuals throughout the metro area report satisfaction with price, selection, and convenience. The Mobile Market welcomes all customers; no proof of income is needed. We accept SNAP/EBT, cash, and credit and debit cards. With the support of food suppliers such as the Hmong American Farmers Association, the Mobile Market will offer fresh, locally grown produce, and it will only stock high-quality, whole foods—no processed, high-calorie junk food. Through partnerships with other organizations, the Twin Cities Mobile Market will be adding resources for customers such as cooking demonstrations, incentives for EBT customers, healthy recipes, and nutrition education. Support for the Twin Cities Mobile Market is provided by UCare, the Statewide Health Improvement Program, the Latino Economic Development Center, Innové, and many other donors and partners. A schedule and map of stops can be found at www.twincitiesmobilemarket.org.


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10 Questions

Oocyte cryopreservation Colleen Casey, MD Dr. Casey is a partner physican at the Center for Reproductive Medicine in Minneapolis. She is board-certified in Ob/Gyn and Reproductive Endocrinology and Infertility.

Please tell us about freezing human eggs. Fertility in women peaks in their early twenties and declines thereafter. This decline steepens around the age of 35 but is most pronounced at ages 38–40. Not only is the chance of pregnancy decreased, but there is a steady rise in miscarriage due to genetic abnormalities as women age. Egg freezing allows women to store younger (and healthier) eggs for later use. The process begins with a consultation with a fertility specialist. Typically the egg-freezing process takes approximately five weeks, with approximately five to six office visits for ultrasounds and blood tests during the last two weeks. Egg freezing is very similar to in vitro fertilization (IVF). The patient will take medications (hormone injections) to stimulate her ovaries to produce multiple follicles, most of which will contain an egg. Over this time period we monitor her response with blood tests and ultrasounds. The egg retrieval, conducted in our office, takes 10–15 minutes and does not require incisions. The eggs are then frozen through a process called vitrification in the laboratory. Patients typically recover for 30 minutes after the egg retrieval and are free to go home. Regular activity usually can begin the next day, although it can take up to a couple of weeks for her ovaries to return to normal size. Women with recent diagnoses of cancer can expedite this process. Some chemotherapy medications can destroy women’s eggs, and chemotherapy may need to be started in a timely manner. In these cases, the freezing process can be shortened to 12–15 days. How has the technology around freezing human eggs changed since it started? In 2012, the American Society for Reproductive Medicine (ASRM) announced that egg freezing was no longer considered experimental. Egg freezing is now considered both safe and efficacious. The success of egg freezing has improved recently due to vitrification. Under the old method of freezing, the size and amount of fluid within the egg produced ice crystals. Vitrification is a form of “flash freezing,” which allows the egg to form a glass-like appearance, minimizing the ice crystal formation and improving the survival rates.

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Minnesota Health care news June 2015

Why would women want to consider freezing their eggs? Age is the most important factor predicting fertility. Women are most fertile during a relatively short time that often coincides with career advancement, education, not having a partner, or other personal reasons in which starting a family is not ideal. Freezing eggs is a good option for women with a recent cancer diagnosis requiring treatment that may affect fertility. It could prevent the need for using an egg donor. Some people may be concerned about ethical issues around this process. How do you address those issues? Eggs are frozen and in order to achieve a pregnancy, the egg must be thawed, then fertilized in the laboratory with subsequent transfer of an embryo five days after fertilization. She may have extra embryos to freeze after her transfer. Some patients are not comfortable with the process of IVF for either religious or personal reasons. I discuss this with patients ahead of time as occasionally patients want to limit the number of eggs fertilized or embryos frozen. Freezing eggs does not guarantee a future pregnancy, but with the introduction of vitrification, the survival of the eggs has greatly improved with higher success of pregnancy. Women of all ages inquire about egg freezing. The earlier she considers egg freezing the better, but if done too early she may not need to use them and will pay storage fees for much longer. Successful pregnancy after egg freezing beyond 40 years of age is quite low.


Patients are also counseled on the risks of pregnancy as they age. At the Center for Reproductive Medicine (CRM) we would transfer embryos through a woman’s 50th year of life, provided she is healthy. Consultation with a high-risk obstetrician is often encouraged to review the risks of advanced age and pregnancy, such as preeclampsia, diabetes, and increased rates of cesarean section.

Please tell us about the success rates from freezing eggs—how many eggs should be frozen, how many result in births, etc. The success rate of freezing eggs depends on a number of factors, the most important being the age of the woman at the time of egg freezing. Other factors we consider are previous fertility, ovarian reserve testing, and response to the stimulation medications.

Another concern is the health of the child. The number of children born from frozen eggs is still small and there is no indication, at present, that they are at increased health risks later in life.

An article in the journal “Human Reproduction” in 2010 published success rates after egg freezing. They reported a 4.5–12 percent pregnancy/egg thawed with overall success rates ranging from 36–61 percent. Other studies have concluded that the chance of pregnancy is reasonable if six or more eggs are frozen in one cycle.

The success of egg freezing has improved.

What are the differences/benefits between freezing eggs and freezing embryos? The process of freezing embryos requires fertilization with sperm, whether from a partner/spouse or a sperm donor. The embryo therefore contains genetic information from the egg and the sperm. The embryo from a partner/spouse is genetically related to the embryo and will have legal rights and responsibilities to the child. The first successful birth after transferring a previously frozen embryo was over 30 years ago, and success rates have greatly improved since. We have more experience and data on children born from frozen embryos. For married/partnered women who wish to delay pregnancy, freezing embryos makes logical sense. For patients without a partner/spouse, egg freezing allows for fertilization later with a desired partner/spouse. Please discuss the financial details around freezing human eggs. The process to freeze eggs costs approximately $10,000, depending on the dose of medications needed for women to stimulate their ovaries. At the CRM we will determine how much may be covered by insurance prior to starting the process. This cost includes the first year of storage; the annual cost to store the eggs thereafter is $750.

What advice do you have for anyone considering this process? Women should consider the emotional impact of freezing eggs. Things to consider ahead of time: • Am I a good candidate to freeze eggs? What if I don’t produce enough eggs to freeze (due to advanced age or decreased ovarian reserve)? • Can I afford the process? • How will I talk to my future partner/spouse about the fact that I previously froze my eggs? • When I am ready to become pregnant should I try on my own or immediately thaw my eggs? • What if something happens to me? What will happen to my eggs?

NOW OPEN!

The process to later transfer the embryos is an additional $7,000, which includes the cost of medications, thawing the eggs, fertilization, and transfer of the embryo/embryos. Please discuss some of the statistics around the birth rates from frozen eggs, contrasting European and American data. I am not aware of statistics specifically addressing differences in birth rates between Europe and North America from frozen eggs, but there are published studies comparing live birth rates from IVF cycles with embryo transfer. The reported live birth rates in North America are higher. Published reports attribute this to differences in ovarian stimulation protocols, egg retrieval techniques, and higher quality laboratory conditions. Some European countries mandate the number of eggs that can be fertilized and only allow single embryo transfer, which can affect live birth rates. What oversight governs the process of freezing human eggs? We report IVF cycles to the Society for Assisted Reproductive Technology (SART); reports are posted at www.sart.org/. As of today, there are no requirements to report outcomes specifically to women who froze and later thawed their eggs to achieve pregnancy. Our reports include fresh embryo transfers, frozen embryo transfers, and donor IVF cycles (both frozen and fresh donor egg cycles). For a woman freezing her eggs, there is a lag time from when she freezes her eggs to later thawing and transferring the embryo. When a woman comes back to thaw and use her eggs, she will most likely undergo a fresh transfer. This would be reported under a fresh IVF cycle.

June 2015 Minnesota Health care news

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Research

The Brain Health Registry Accelerating the path to cures By Michael Weiner, MD

A

s the aging population grows, physicians are seeing more and more patients with brain disorders such as Alzheimer’s disease, Parkinson’s disease, depression, and post-traumatic stress disorder. Alzheimer’s disease alone affects one in eight older Americans and is the sixth-leading cause of death in the U.S. The impact on patients and their families is devastating. Yet, despite the prevalence of brain-related disorders among the growing elderly population, we still don’t have effective treatments for Alzheimer’s and other neurological diseases. This is unacceptable. We simply must find ways to accelerate research that will lead to effective therapies. If we don’t, the terrible toll on patients and their families will continue.

Do you or a child in your family suffer from depression, ADHD or high levels of anxiety? Torque Release Technique (TRT) is a specialized form of neurological chiropractic. No twisting or turning is involved. This effective, non-invasive, medication-free treatment has produced dramatic results for both children and adults.

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There is great work going on in this area in Minnesota. The physicians and scientists in the Alzheimer’s Disease Research Center at Mayo Clinic are at the forefront. Ronald Petersen, MD, PhD, is world famous for his recognition that mild cognitive impairment is a clinical stage on the continuum between normal aging and development of dementia due to Alzheimer’s disease. Many other scientists at Mayo Clinic have also made significant contributions to the field. At the University of Minnesota, the Center for Magnetic Resonance Research led by Kamil Ugurbil, PhD, has also been a world leader in developing the most advanced, state-of-the-art MRI imaging techniques. Furthermore, “functional MRI” was first performed at this center, leading to the development of an entire field that is impacting research and diagnosis of Alzheimer’s disease. Therefore, investigators from Minnesota have produced and continue to come forth with some of the most outstanding research advances in the field. The research challenge Despite progress, there is an urgent need to speed research into neurological diseases. But one of the biggest impediments is the difficulty of finding people willing to enroll in studies and clinical trials. Recruiting study participants is both expensive and time-consuming, with recruitment accounting for about a third of the total cost of running a clinical trial.

•Lessday-to-daystress •Anxietyanddepressionrelief •Improvedmentalfocus •Improvedsenseofwell-being •Deepersleep,moreenergy What some of our patients had to say:

In the case of Alzheimer’s, we know that the major risk factor for the disease is age: the older you get, the greater the risk. Genetics also plays a very important role; the second major risk factor is family history. For people whose parents or grandparents had dementia to Alzheimer’s disease, their risk for developing Alzheimer’s increases three- to fourfold. Some of this risk is due to the gene APOE4, but other genes also seem to be involved. There are still a lot of questions left to be answered.

Minnesota Health care news June 2015

It is particularly difficult to recruit patients for studies of neurological diseases. Among the major challenges are identifying at-risk cohorts of sufficient size. The problems in recruitment are several fold. First, large numbers of subjects need to be recruited, because many subjects who volunteer will fail to meet the criteria of the specific study and will be screened out. Second, each clinical trial or neuroscience study currently recruits subjects separately. Third, when subjects are recruited and screened, the only data that is available is the data obtained at the time of recruitment. There is no longitudinal data available that might help determine eligibility. In summary, the needs are to recruit large numbers of subjects at low


cost, to obtain screening information, and to obtain longitudinal information prior to entry into a treatment trial. Given the significant hurdles in recruiting study participants, my colleagues and I thought long and hard about potential solutions, and we came up with a website called the Brain Health Registry (www. brainhealthregistry.org). The primary goal for this web-based effort is to recruit as many as 100,000 people into studies of neurological diseases by the end of 2017. Our goal is to recruit, assess, and longitudinally monitor subjects and refer them into clinical trials including treatment studies. If we can do that, we can speed up research on brain diseases and thereby accelerate the development of effective therapies.

Based on the needs of the research community, the Brain Health Registry may use information collected on the website to identify potential participants for clinical trials to test diagnostic tools and potential therapies for brain disorders. Participants will only be contacted about participating in clinical trials already approved by UCSF’s IRB. Once given the opportunity to participate in a clinical trial, the choice to participate or not will always be up to the patient.

Anyone 18 and older can register to participate in the Brain Health Registry.

How it works The Brain Health Registry is designed to find potential study participants more quickly and at less cost, thus reducing the time and costs associated with clinical trials for brain disorders such as Alzheimer’s disease. Simply put, the website gathers cognitive testing data online from registered members who complete questionnaires and tests on the site. Anyone 18 and older can register to participate in the Brain Health Registry, whether or not they have a family history of brain disease or neurological risk factors. The registry is designed to detect changes over time in a person’s cognitive brain health, which is why it is important for people of all ages to participate. But we are particularly hoping for sign-ups from the over-50 population. The project was launched in 2014 and is overseen by UCSF Medical Center. Every aspect of the project is reviewed and approved by the UCSF Institutional Review Board (IRB). Ensuring that safeguards are in place to protect participants’ privacy is a high priority. Those who sign up to participate on the site are first asked to sign a consent form. Next, they complete a series of questionnaires about their personal and family medical history and about their diet, sleep, exercise, and lifestyle. Once the questionnaires are completed, participants are asked to take some neurological tests in an online game format. Given the important role of genetics in brain diseases, we also have plans to collect DNA from willing participants. Participants are asked to revisit the site every three to six months to engage in these online cognition games. Participation takes an estimated one and a half hours per visit or about three hours each year. Data from the online assessments is collected over time and analyzed to identify potential candidates for clinical trials and other studies on brain-related diseases. My colleagues and I think the Brain Health Registry will become an important tool to speed outreach to candidates for clinical trial recruitment and for other research purposes that involve data collection and analysis. Similar to the Stand Up 2 Cancer model, which was created to accelerate innovative cancer research, the Brain Health Registry is partnering with researchers across the country to collaborate in finding treatments and cures for brain diseases.

Another advantage of the Brain Health Registry is that it will reduce the need for individual recruitment efforts. We are very interested in helping genetics studies recruit, assess, and monitor subjects longitudinally.

The more members who join the Brain Health Registry and who continue their participation over time, the more data can be collected to help find viable candidates for clinical trials. This normally is a process that can take years to accomplish. We think the Brain Health Registry can help streamline that process and help recruit more diverse, but underrepresented populations including ethnic and socio-economic segments. Progress so far During the past year, more than 12,000 people have enrolled in the Brain Health Registry. About half of those who have signed up have returned for a six-month follow-up visit. The initial data is very exciting and is of high quality. We have found significant effects of age, gender, sleep, depression, and memory complaints on cognitive functioning. We have reported the findings at international meetings, and papers are being prepared for submission to scientific journals. We have partnerships with Cogstate and Lumos Labs (both of which provide online cognitive tests) and Johnson & Johnson, which is funding a validation study. We’re off to an exciting start. But more needs to be done to make this a success. We need to continue to grow the number of members and to encourage them to continue revisiting the site. We are building partnerships with organizations such as the Alzheimer’s Association and Alzheimer’s Prevention Initiative. We are starting to seek enrollees outside of the San Francisco Bay Area, including the Minneapolis/St. Paul area and surrounding counties. How you can help We hope you will join the Brain Health Registry. It only takes about an hour a few times a year. It’s a practical way, without cost, to help advance scientific research leading to effective treatments for brain disorders, including Alzheimer’s disease. The website gives people a chance to participate in meaningful research aimed at developing effective therapies for devastating brain disorders. Also, their participation may lead to access to clinical trials they may want to participate in. We believe the Brain Health Registry will lead to faster cures for brain disorders. We ask you to join our effort. Michael Weiner, MD, is founder and principal investigator of the Brain Health Registry and professor of radiology and biomedical engineering at the University of California at San Francisco. June 2015 Minnesota Health care news

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Behavioral health

Mental illness and our youth An important new resource for pediatricians By Todd Archbold, LSW, MBA

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early one in four individuals in Minnesota will experience symptoms of a mental illness at some point. This means that almost everybody will feel the impact of a friend, loved one, or even themselves dealing with these all too common conditions. For the youth in our state, the impact may be particularly acute. Minnesota lags behind many other states in access to child and adolescent psychologists, leading many youth and families to rely on nonspecialists…or to delay seeking help until they face an emergency.

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PrairieCare Medical Group’s new Psychiatric Assistance Line (PAL), funded by the Minnesota Department of Human Services (DHS), may help to bridge that gap by offering mental health triage and telephone consultations to primary care providers throughout Minnesota. Issues and implications Anxiety disorders and depression are by far among the most common diagnoses, followed by attention deficit hyperactivity disorder (ADHD) and substance abuse disorders. While most psychiatric conditions are highly treatable and we have growing resources in Minnesota to help individuals and families, the troubling news is that most people will never seek help or access the treatment necessary to alleviate their symptoms. We are also learning more each day about patients who suffer from both general medical conditions and psychiatric disorders. These “comorbid” disorders greatly increase the likelihood of exacerbated symptoms for both conditions. For example, individuals diagnosed with both diabetes and depression are statistically less likely to follow through with diabetes treatment due to their depression, and may experience worsened depression due to their diabetes. Not only are clinical outcomes decreased, but the cost of care increases more than three to five times above the cost of treating just one diagnosis.

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Minnesota Health care news June 2015

The impact on youth Minnesota boasts some of the country’s most efficient and innovative health care systems and one of the highest rates of personal health insurance. In 2013, the United Health Foundation ranked Minnesota as the third healthiest state in the country. Despite these positive trends, our state ranks among the lowest in the country in terms of access to child and adolescent psychiatrists. Some estimate that we would need 350 child and adolescent psychiatrists to meet the need of the most complex cases; current estimates of practicing board-certified child and adolescent psychiatrists in Minnesota number just 75.


This shortage of child and adolescent psychiatrists (CAPs) has shifted the burden of providing mental health care to primary care clinicians, many of whom feel ill equipped to manage complex psychiatric illnesses during brief office appointments with little or no psychiatric support. Primary care clinicians also represent a significant majority of the increased prescription rates of psychotropic medications such as antidepressants and stimulants. Access to child and adolescent psychiatry often requires lengthy waitlists in the outpatient setting, or, worse yet, is secured only when psychiatric conditions spiral into emergencies. Nationwide, hospital emergency rooms are becoming more crowded with patients in psychiatric emergencies. Many of these emergencies could be prevented if early access to psychiatrists or psychiatric consultation were available to patients and primary care providers. The lack of access to care, and the failure of early identification, results in further social developmental problems and a significant worsening of symptoms, not to mention increased financial costs for families, hospitals, and taxpayers. In many cases, pediatricians and other pediatric primary care providers are best suited to assess and provide care for behavioral health issues. Although there are limitations in their training and comfort in treating these conditions, they have several advantages. They generally enjoy positive and trusting relationships with children and families; are on the “front lines” for most health issues; have extensive practical knowledge of normal development, allowing them to detect problems at an early state; and they have a reduced stigma associated with behavioral health treatment and settings.

ule their own appointments online, and a PAL triage social worker will call them when most convenient. PAL benefits patients and families by allowing the assessment and management of mental illness to take place in their primary care provider’s office. This means more kids are getting help sooner and avoiding the cost and trauma of untreated mental illnesses. Before launching the service in 2014, administrators at PrairieCare Medical Group surveyed pediatricians in the Twin Cities metro area to gather input in designing such a service. Nearly 90 percent of survey respondents said that they wanted help with questions about specific psychotropic medications and 83 percent wanted help with dosing. Another 66 percent wanted help with diagnosis or assessment and 44 percent wanted help with triage and referrals for other behavioral health services. About half of the respondents reported either “never” or “rarely” having access to CAP services, and 89 percent said they would be more likely to manage psychiatric conditions if access to a CAP was more readily available. In an analysis of 100 sample consultations performed by PAL, the patient ages ranged from three to 39. Seventy-seven percent of the patients were between the ages of three and 21, with 59 percent of patients male and 41 percent female. The most common diagnosis treated was anxiety, which, combined with depression and ADHD, comprised 68 percent of all the consultations. Mental illness and our youth to page 34

The Psychiatric Assistance Line (PAL) Since 2011, the Minnesota Department of Human Services has provided grant funding to support primary care access to child and adolescent psychiatry, as required by legislation passed in 2010. PrairieCare Medical Group’s Minnesota Psychiatric Assistance Line offers free clinical triage and child and adolescent psychiatric phone consultations to pediatricians across the entire state. PAL is staffed by a full-time clinical social worker who has immediate access to a CAP.

stdavidscenter.org 952.548.8700

Funded by DHS, the service is augmented by the Fast-Tracker online mental health database. Toll-free lines are available weekdays from 8 a.m. to 5 p.m.; online options for access are available as well. Starting in July 2015, availability will increase to 7 a.m. to 7 p.m. The purpose of PAL is to support primary care providers to treat youth with mental illnesses in a safe and effective way. Previously, children with complex psychiatric conditions would either be referred to a child and adolescent psychiatrist and have to endure lengthy waitlists, or the pediatricians would simply do their best to manage the cases themselves with limited training. While a few pediatricians are well adept in managing diagnoses such as ADHD and depression, many are not comfortable treating those conditions and have to make referrals elsewhere. Many studies have shown that less than half of the patients referred out for care actually follow through with the appointment with the child and adolescent psychiatrist. PAL is designed to be convenient, offering both on-demand phone and online services. Primary care providers can submit online inquiries, which are answered by secure email. They can also sched-

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June 2015 Minnesota Health care news

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public health

The Minnesota Poison Center A life-saving resource By Kirk Hughes, RN, EMT, CSPI

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oisonings can happen anywhere, anytime, to anyone. According to the American Association of Poison Control Centers (AAPCC), America’s 55 accredited poison centers received 3.1 million calls in 2013. The AAPCC’s Poison Help hotline, 800222-1222, is a national number that automatically directs callers to the appropriate regional poison center. All calls are confidential and available at no cost to the caller. Serving all Minnesotans The Minnesota Poison Control System is designated by the Minnesota Department of Health to provide emergency poison man-

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In 2014, the Poison Center received 48,446 calls from all 87 Minnesota counties. Twenty-three percent of those calls were from health care providers seeking guidance to treat poisoned patients and 77 percent were from the public. The Poison Center also provides poison prevention and outreach education to communities statewide. Physicians, pharmacists, nurses, and emergency responders are trained in the care of patients exposed to toxins in all their forms—environmental, occupational, and medication-related. Saving lives The Poison Center is staffed by specially trained pharmacists and physicians 24 hours a day, seven days a week, and 365 days a year. Pharmacists undergo a year of extensive specialized training to become certified as a Specialist in Poison Information (CSPI). CSPIs assess, manage, monitor, and follow up with patients exposed to harmful substances (prescription drugs, drugs of abuse, chemicals, household products, plants, and animals). Pharmacists can also provide information about adverse drug reactions, dosing, and medication errors if the prescribing physician or the patient’s regular pharmacist is unavailable. Saving money In 2014, the Poison Center saved Minnesotans $35 million dollars in unnecessary health care costs by safely advising treatment in the home setting 91 percent of the time. This prevented over 27,000 needless emergency room visits. For every dollar invested in poison centers, more than $13 in medical costs and lost productivity are saved, according to “Value of the Poison Center System,” a 2012 report released by the Lewin Group, a Washington, DC-based health and human services consulting firm.

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agement and poison prevention information. Its primary service is the AAPCC-accredited Poison Center, located at Hennepin County Medical Center in Minneapolis.

Providing public health services Poison centers are often the first to identify emerging public health threats, including food-borne illnesses, tainted medications, and new drugs of abuse. The Poison Center partners with state and federal agencies to provide critical public health surveillance, all-hazard disaster preparedness, and emergency response. This co-

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ordinated effort allows for not only the early recognition of emerging public health threats, but also for the rapid containment and management of these threats.

77 percent of poison-related emergency room visits were related to exposure to medications. Poison prevention In 1961, President Kennedy signed Public Law 87-319 designating the third week of every March as National Poison Prevention Week. With poisoning still a significant cause of serious illness and death in the United States, the Poison Center urges everyone to practice good poison prevention habits every week.

free of charge through the Minnesota Poison Control System’s website at www.mnpoison.org. Many other poison-related resources are available on the website. On the cutting edge of new trends Children are also at risk of inadvertent exposure to new products. Single-use concentrated laundry packets, packaged in water-soluble wrappers, may be attractive or resemble food. Small children have sustained burns to the eyes, mouth, and throat after exposure to these products, and some have become critically ill. Liquid nicotine, in the form of E-juice for electronic cigarettes, is marketed in a variety of flavors such as bubble gum, blueberry, and The Minnesota Poison Center to page 19

Only 4 percent of parents expressed concerns about poisoning, according to “A Report to the Nation: Protecting Children in Your Home,” a recent study conducted by Safe Kids Worldwide. Another Safe Kids Worldwide report indicated that 77 percent of poison-related emergency room visits were related to exposure to medications belonging to a parent or grandparent. In 2014, children under the age of six accounted for 45 percent of poison-related calls to the Poison Center. Providers at all levels can help to prevent child poisonings by following a few simple poison prevention strategies: • Keep medicines and household products in their original containers. • Keep all medications and household products up high and out of sight or locked up. If visitors are expected in your home, make sure suitcases and purses are stored out of children’s reach and sight. • Read and follow the label before taking or giving medication. • Never call medicine “candy.” • Never take medication in front of children. They model actions of a trusted adult. • Remember, child-resistant is not child proof. Child-resistant packaging is designed to delay access by toddlers to potentially dangerous substances, but does not take the place of safe storage or adult vigilance. Home poison treatment over the years In November 2003, the American Academy of Pediatrics (AAP) released a position paper regarding use of syrup of ipecac in the home. After a review of available evidence, the AAP determined that this home remedy was not effective and in some cases caused life-threatening complications. As a result, home use of syrup of ipecac was formally discarded by pediatric and toxicology providers. Today a single call to the national Poison Help hotline connects callers to a local poison center that can provide tailored, real-time treatment recommendations. This number should be programmed into all home and cell phones. If a person is unconscious, having difficulty breathing, or having a seizure, then 911 should be called. Free Poison Help stickers, magnets, and brochures can be ordered June 2015 Minnesota Health care news

17


Calendar June-July 2015 June 24

Varicose Vein Screening

Park Nicollet offers free screenings for anyone bothered by visible, bulging veins in their legs that cause pain, swelling, or cramping. Surgeons will perform the screening and recommend a course of action. Those covered by Medicare or Medicaid are not eligible due to federal regulations. Other dates are also available through August. Call (952) 993-2651 to schedule your screening. Wednesday, June 24, 3:30–4:30 p.m., Park Nicollet Heart and Vascular Women’s Center, 5th Floor, 6500 Excelsior Blvd., St. Louis Park

25

Health Insurance Counseling for Seniors

The Metropolitan Area Agency on Aging and Hennepin County Library host this free class. A certified state health insurance counselor will be onsite to assist with enrollment steps, plan choices, and determining low-income subsidies. Several dates and times are available. For more information or to RSVP, call (612) 543-8375. June–August 2015, Southdale Library, 7001 York Ave. S., Edina

July 9

Prostate Cancer Support Group

HealthEast offers this support group for men with prostate cancer. Gather in a supportive setting to learn the latest treatment information, learn how to deal with side effects, and hear others’ firsthand experiences of diagnosis and treatment. Partners are welcome. No registration necessary. Call Tammy at (651) 232-7086 or Mary at (651) 232-7833 with questions. Thursday, July 9, 5–6:30 p.m., St. John’s Hospital, 1575 Beam Ave. S., St. Paul

11

Fibromyalgia Support Group

Allina Health hosts this support group for those living with fibromyalgia, chronic fatigue, and other chronic pain diseases. Come meet others living with these conditions and learn about resources to manage them. No registration required. Saturday, July 11, 10 a.m.–12 p.m., Courage Kenny Rehabilitation Institute, 3915 Golden Valley Rd., 2nd Flr. Boardroom, Minneapolis

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Minnesota Health care news june 2015

National Aphasia Awareness Month Aphasia is a neurological communication disorder that impairs a person’s ability to process language. This can include problems with speech, reading, writing, and understanding others, depending on the type and severity of aphasia. It can range from mild, where a person might have trouble retrieving the names of objects, for example, to severe, where communication in any form is very difficult. The most common causes of aphasia are stroke or traumatic brain injury. It currently affects more than 2 million Americans and more than 80,000 acquire it each year, according to new statistics determined at the 2015 AphasiaAccess Leadership Summit. Despite its prevalence, many people have not heard of aphasia. According to the National Aphasia Association, if a person’s aphasia symptoms last longer than two to three months after a stroke, it is unlikely that they will completely recover. However, people with aphasia can slowly improve with proper supports. Understanding the nature of aphasia and finding appropriate resources are important for anyone affected by this disorder.

June 29

Conversation

Practice Group for Stroke Survivors

North Memorial Medical Center offers this informal speech therapy discussion group for stroke survivors. Come have a cup of coffee and practice communication techniques with others on the recovery path. The group meets weekly. Call (763) 520-5200 for more information. Monday, June 29, 10–11 a.m., North Memorial Medical Center, Sunset Room, 3300 Oakdale Ave. N., Robbinsdale

16

Respiratory Health Club

The Coalition for Pulmonary Fibrosis, in partnership with the American Lung Association, hosts this free gathering for patients with emphysema, asthma, chronic bronchitis, pulmonary fibrosis, and sarcoidosis. Families are welcome. For more information or to register, call Cheryl at (651) 227-8014. Thursday, July 16, 1–3 p.m., Lutheran Church of the Good Shepherd, 4801 France Ave. S., Minneapolis

20

Infertility Support Group

RESOLVE: The National Infertility Association offers peer-led support groups for couples experiencing infertility to connect with one another, share their stories, and receive support from others going through similar experiences. Contact the group hosts, Katie and Kendra, at NorthMetroMNresolve@gmail.com before your first meeting. Monday, July 20, 6:30–8 p.m., Ramsey County Upperwood Library, 3025 Southlawn Dr., Maplewood

21

Autism Family Support Group

The Arc Greater Twin Cities hosts this free networking group for parents of children with autism. Come connect with other parents for support and advice. For more information or to register, call (952) 920-0855. Tuesday, July 21, 6:30–8:45 p.m., Faith Lutheran Church, 11115 Hanson Blvd. NW, Coon Rapids

22

Responding to Children’s Challenging Behaviors

PACER Center offers this free workshop for parents to help identify and respond to behaviors that may indicate mental health concerns. Come learn strategies to meet the needs of your child and parent advocacy skills. Registration is required. Call (952) 838-9000 or email PACER@PACER.org for more information. Wednesday, July 22, 6:30–8:30 p.m., PACER Center, 8161 Normandale Blvd., Minneapolis

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


The Minnesota Poison Center from page 17

More information regarding poison prevention, exposure, treatment, and resources can be accessed at www.mnpoison.org or on Twitter @MNpoisoncenter.

Home treatment is mostly common sense cherry vanilla. Nicotine is • Poison in the eyes? Rinse with room temperature water and particularly toxic in children call the Poison Help hotline at 800-222-1222. Avoid use of red and can result in seizures, removing drops as it could mask injury. impaired breathing, and • Poison on the skin? Remove any contaminated clothing the poison death. In Minnesota, touched, rinse skin with running water, and call the hotline. there are currently no Poison Center funding • Inhaled poison? Get to fresh air and call the hotline. requirements to label how Minnesota Statute much nicotine is contained 145.93 defines Minnesota • Swallowed poison? Call the hotline for further recommendations. in each container, but a new Poison Information Services, Minnesota law now requires but provides no funding that each E-juice container for the service. Today, the have child-resistant packaging. Keeping these products locked up or Minnesota Poison Control System is facing a budgetary shortfall. up high and out of sight can prevent exposures. State legislation has been introduced (HF 346/SF 359) requesting an $800,000 increase in annual funding. Funds would be used to Deaths from drug overdose—often involving use and abuse of maintain and enhance staffing to maintain national accreditation prescription medications—surpass deaths from car crashes, accordstandards, health care provider training, public health surveillance ing to separate reports by the Centers for Disease Control (CDC) of emerging toxicology/poison issues, and outreach education to and the Minnesota Department of Health. The Minnesota Poison Control System collaborates with various state and community agen- children and disadvantaged communities. cies to reduce these deaths. Some strategies include making medication disposal sites more accessible and supporting drug take-back programs to reduce the amount of unused prescriptions available to the public. The Minnesota Poison Control System also educates youth about the dangers of illegal and prescription drug use and abuse through youth coalitions and lectures to students.

To learn more about this legislation and steps Minnesotans might take to ensure adequate funding for services and 24-hour call centers, visit www.mnpoison.org and click the “Take Action 2015” tab. Kirk Hughes, RN, EMT, CSPI, is education director/poison specialist for the Minnesota Poison Control System.

Center for Sexual Health Compassionate patient care in sexual health for individuals, couples and families of all backgrounds and ages. Patient assessment and treatment is available in the areas of relationship and sexual problems therapy, compulsive sexual behavior, sexual offending, transgender health services and sexual abuse. HIV counseling, as well as psychological treatment for people living with HIV/AIDS. Our physicians provide care for many medical conditions including (but not limited to) the following: • Compulsive sexual behavior

• Premature ejaculation

• Emotional pain or physical pain with sexual activity

• Sexual abuse

• Erectile dysfunction (ED)

• Sexual desire discrepancies

• Gender identity disorder

• Sexual harassment

• Gender exploration for children and adolescents

• Sexual offending

• Hepatitis

• Sexual orientation

• Mental health

• Sexual problems

• Orgasm problems

• Transgender health Treatments

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

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

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2015 Community Caregivers

Making a difference in Minnesota and the world Katie Klingberg, MD Apple Valley Medical Center

Recognizing Minnesota’s Volunteer Physicians and Health Care Providers Each year, Minnesota Physician Publishing recognizes physicians and health care providers who have volunteered their medical services. Whether volunteering at home or overseas, these caregivers help people in need and come away with a revitalized sense of their work. Their compassion, commitment, and generous spirit reflect the deeply held values in Minnesota’s medical community. Written by Lisa McGowan

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r. Katie Klingberg has been volunteering ever since she can remember. “Volunteering was an expectation—it was something I saw my parents do in our school and parish,” said Klingberg, a family physician at the Apple Valley Medical Volunteers set up Center. She continued a makeshift clinic to volunteer while in in an old church in college, traveling to Chimbote for the Appalachia, Atlanta, week they are there. Washington, D.C., Klingberg works with and the Pine Ridge patients of all ages Reservation in and no one is turned South Dakota. After away. “If a patient graduation, she spent has a need we cannot a year volunteering meet, we work very as a high school hard to help connect teacher in innerhim or her with city Chicago, where doctors in Lima or the many of her students United States,” she had been touched said. Klingberg enjoys by gang violence, meeting people from teen pregnancy, and different backgrounds, My volunteer work poverty. It was an cultures, and and advocacy will eye-opening and circumstances on the life-changing year. missions and finding never be done. She continued to common ground volunteer throughout with them. “I have her medical training, repeatedly witnessed stopping only to marry and raise three the power of compassion and gratitude that children. Klingberg’s oldest daughter, people express just knowing that others Lindsey, joined her on a medical mission trip care,” she said. to Peru last year. On her last trip, Klingberg was asked to Klingberg volunteered in 2012 and 2014 with Los Amigos Medical Aid (LAMA)—a group founded in 2006 by Dorothy and Tony Brama of Prior Lake, Minn. LAMA annually sends a medical team to Chimbote, an impoverished fishing port on the north coast of Peru. Many residents of Chimbote lack even the most basic necessities such as running water, beds, or electricity. Klingberg was shocked by the poverty she saw on her first trip to Chimbote. “The hospital I visited in the center of the city had dogs and cats

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Minnesota Health care new June 2015

roaming the hallways,” she noted. LAMA sends a medical team to Chimbote to provide basic medical, dental, and eye care, and ships donated medical supplies, home goods, and school supplies every autumn. In Peru, one does not receive medical care unless one has insurance or the cash to pay for it, leaving many with no hope of receiving good medical care or medication.

visit a teenage boy with special needs who was suffering from respiratory distress. She found him in the hospital unconscious, unattended, and gasping for air. She argued for better care for him, but resources were scarce, and the staff was overstretched. Klingberg later found out that the boy had died. “I will never forget that I could not save him in a system that is so broken. This boy’s plight reminds me that my volunteer work and advocacy will never be done.”


Paula Schwartz, AuD Audiology Concepts

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aula Schwartz never thought that her expertise as an audiologist had a place in volunteer missions overseas. “I was so envious of doctors who possessed the skills to really make a difference in the lives of the underprivileged,” Schwartz said. So she was thrilled when the opportunity recently arose for her to be part of a surgical team heading to Guatemala. She and colleague Kathy Wieser, who also works at Audiology Concepts, provided audiological and hearing aid services to people traveling many miles to seek help for their hearing challenges. The weeklong mission was organized by Faith in Practice, an ecumenical Christian organization that seeks to improve the physical, spiritual, and economic conditions of the poor in Guatemala. Faith in Practice provides solarpowered body aids that enable people with profound hearing loss to hear. Schwartz and Wieser saw 150 patients in Guatemala with significant hearing loss due to the neglect of standard medical care in rural areas. Many of these patients have not been able to hear or communicate for much of their lives. Schwartz, who owns

Audiology Concepts, said, “I believe that hearing is paramount to every aspect of our lives. To provide amplification from solarpowered body aids is certainly a gift.”

the teen on her 14th birthday, Schwartz had the honor of telling Flora that her hearing was normal and she no longer would be labeled “deaf.”

Before traveling to Guatemala, Schwartz On the first day of clinic on Schwartz’s volunteered on several Rotary International recent trip, a 14-year-old girl named Flora Service trips over came in wearing the past four a body aid that years. Schwartz she received last was awarded the year. According International Service to Schwartz, Award by her club in “Flora’s aid wasn’t 2013. She volunteered functioning, but the in India giving lifefact that I could still saving polio drops to communicate with children and worked her told me that in the International something wasn’t Village Clinic. She right.” Last year’s also raised money to audiogram showed support a girl’s school that Flora had a in northern India and profound hearing My passion lies in for a playground for loss. Schwartz international service. abused and neglected retested Flora and children in Nepal. identified a moderate As a Rotarian, conductive hearing Schwartz also loss and sent Flora to the ENT for further evaluation. The ENT volunteers locally but said, “My passion lies in international service.” scheduled surgery the next day and cleaned out a problematic middle ear, which restored her hearing to near normal. After retesting 2015 Community Caregivers to page 22

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To schedule an appointment at any of our 13 locations, please call 763-780-6699 or visit www.sgsmn.com June 2015 Minnesota Health care news

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Steven Kern, MD Specialists in General Surgery

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wenty-six years ago Dr. Steven Kern began volunteering when he was in college because he hoped to save the world. He spent two summers in the Dominican Republic with the Institute for Latin American Concern sponsored by Creighton University. Although he quickly realized that he couldn’t save the world by himself, he got a tremendous amount of satisfaction from donating his time to those in need. Three years ago he went back to volunteering in the Dominican Republic and Haiti, this time as a surgeon. He credits his wife Anne, whom he met while volunteering in the Dominican Republic, for renewing his desire to volunteer overseas again. Kern is a general surgeon who practices with Specialists in General Surgery in Maple Grove. According to Kern, “Most of the patients have little or no access to surgical care or if they do they can’t afford it.” He volunteers with Hernia Repair for the Underserved, which is associated with the same organization he volunteered with in college. During a weeklong mission he and a team of doctors, nurses, and technicians

Kern. There are many organizations in need of medical expertise and the process of getting involved for most physicians requires very little effort. Locally he has seen some of his physician colleagues like Jack Graber, Paul Severson, Jeffry Twidwell, and Leslee Jaeger donate their time and medical skill overseas and he has taken their dedication to heart. On the other side of the coin, He sincerely Kern has witnessed hopes to inspire colleagues leaving other physicians to medicine because of The sense of goodwill volunteer. Although burnout and feels his work has helped you will receive is that volunteering many in Haiti and intoxicating. mitigates this problem. the Dominican His advice to other Republic, he often physicians as far thinks that he as volunteering is, gets more from “Put aside a week and go! The sense of the experience than the patients he helps. accomplishment you will feel and goodwill “I believe that we should help people less you will receive is intoxicating. You will fortunate than ourselves for many reasons, but in the end we benefit from it too,” stated want to do it again.” typically repair 70 to 80 hernias and hydroceles. Some of the operating facilities that they work in are quite modern, while others are very rudimentary. “We bring much of our own equipment,” said Kern. “One operating room in Haiti had insufficient lighting so I brought the brightest rock climbing head lamp I could find.”

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Minnesota Health care new June 2015


Kelsy Kuehn, MS, PA-C Multicare Associates

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elsy Kuehn, a physician assistant with Multicare Associates, recently returned to Minnesota after volunteering in Liberia for three months. Last November, the American Refugee Committee sent a team to Liberia, including Kuehn, to open a new Ebola treatment unit (ETU). Upon arrival, she was trained in the proper donning and doffing of personal protective equipment (PPE) so she wouldn’t become infected with the Ebola virus. Kuehn remembers thinking just before entering the “hot zone” for the first time, “I am not scared of Ebola because I have full faith in the PPE.” She worked briefly with Ebola patients during her training. Because construction of the new ETU was delayed, she was sent to work in the community clinic in Fish Town instead. Her work in Fish Town did not involve working with Ebola patients since the epidemic had not taken hold in River Gee County. Fish Town is a remote, rural community in southeastern Liberia without electricity or plumbing. Poverty there is rampant. It didn’t take long for Kuehn to note, “The health care problems run deep in Liberia.” The second

Daniel Sampson, DDS, MD OMS Specialists

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reating homeless and underserved patients while he was a resident in San Francisco had a significant impact on Dr. Daniel Sampson. “My fellow residents and I would often box up our free dinners from the hospital and bring them out to the homeless on the hospital grounds.” Once Sampson returned to Minnesota, he started volunteering at local clinics while raising children and meeting the demands of a practice.

An oral and maxillofacial surgeon, Sampson practices at OMS Specialists and is the associate chief of surgery at Children’s Hospitals and Clinics. Sampson has been volunteering for 15 years both in Minnesota and Mexico. At home he works with Minnesota Mission of Mercy; Sharing and Caring Hands; Project Homeless Connect; and Special Olympics Special Smiles about six times a year to provide routine oral surgery care to homeless and indigent patients. He also serves on the board of directors for Apple Tree Dental, a nonprofit dental organization that serves nursing home residents, people with disabilities, and low-income families.

civil war ended in grandson in who was so 2003, but left the weak he could not stand country and its up. “The clinic had no health care system tests to run to see if there shattered. Liberia is was a disease causing chronically short of the child to waste away. health care workers, We had no supplements equipment, and on hand to give him drugs. According either,” said Kuehn. She to Kuehn, “Health recommended that the care providers grandmother take him to can go for months the closest hospital, but without being paid her advice was ignored. and as a result often Nothing had really don’t show up for prepared Kuehn for the work. Corruption lack of infrastructure and Humanitarian is not uncommon, for how some Liberians work is often very with some health approach health care. care providers People, who have little complicated. selling medication reason to trust authority, or charging for often ignore medical procedures that advice. Liberians also should be free.” It’s a frustrating system and tend to avoid hospitals and ETUs out of ultimately it left Kuehn feeling helpless and fear that their loved ones will be cremated wondering if her work really made much of a and not buried according to their traditions. difference in the long run. Despite all of this, Kuehn said at the end of her sojourn, “This has not been a regrettable Kuehn saw patients who walked many experience. Humanitarian work is often very miles to visit the clinic. One day, a woman complicated.” brought her emaciated, two-year-old

Once a year, Two years ago, Sampson travels Sampson was part of to Hermosillo in a team that repaired northwestern Mexico a 10-year-old boy’s through Children’s cleft lip and palate. Surgery International, The young child was an organization abandoned by his that provides parents and left to fend specialized surgical for himself on the streets and medical care of Hermosillo. The boy to underprivileged was taken in by several children around the mechanics and allowed world. Sampson to live in their shop. provides alveolar cleft According to Sampson, bone grafting, closure “The mechanics heard The reward of a parent of fistulas, and other about our surgical cleft care working mission and brought smiling when they see alongside surgeons him to us for help. The their child’s face after who repair lips and fact that these guys took surgery is immeasurable. palates. Parents often this child in was really travel long distances touching.” to get care for their Sampson loves children. For many helping patients who it’s their first exposure to modern medicine or are in pain and rebuilding faces that were surgical care. “Parents are often frightened about incompletely formed. “The reward of a parent the procedures but they put their trust in us,” smiling when they see their child’s face after Sampson said. “It’s amazing how within 24 hours surgery is immeasurable,” said Sampson. “Hugs, of meeting us, these parents place their children handshakes, smiles, and tears of gratitude make in our care for significant surgical procedures.” it all worthwhile.”

June 2015 Minnesota Health care news

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Anne Tofte, MD Grand Itasca Clinic and Hospital

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r. Anne Tofte volunteers at Project Care’s Free Clinic in Grand Rapids to help the uninsured in the Iron Range get much-needed medical care without incurring exorbitant debt. Project Care provides free health care and networks with community-based organizations to ensure that patients get continued treatment, screenings, and education. “What Project Care does very well is case management. This is something that larger organizations could learn a lot from,” said Tofte. Patients get help applying for insurance and finding affordable medication. A site coordinator from the clinic also makes follow-up phone calls to review lab results, check on patients’ progress, and answer any questions.

Tofte is a family physician and practices at Grand Itasca Clinic and Hospital in Grand Rapids, Minn. She feels very strongly that everyone deserves access to affordable medical care. “As a working physician and a Mom with an already busy schedule, volunteering once a month at the Project Care Grand Rapids Clinic is something I feel very passionate about,” noted Tofte.

The Grand Rapids Clinic is open on that they don’t provide for patients and pride Tuesday evenings and is housed in an old themselves on their success. office building with two exam rooms. Tofte remembers Working at the clinic working with Dr. Tim allows Tofte to get Rumsey at the Dorothy back to the basics of Day Homeless Shelter what she does as a in St. Paul when she physician, “It helps was a resident. He is me remember why I committed to caring for went into medicine the underprivileged in and the patients are his everyday work and incredibly grateful.” in his work with the According to Tofte, homeless. “Dr. Rumsey “There are many forces helped me see that at work in today’s everybody has a story; medical climate that they are all humans can suck the passion who deserve to be cared out of physicians. for. He also helped me Volunteering is understand that the an opportunity to factors that contribute Everyone deserves reconnect with your to homelessness are access to affordable original goals and ideas often more complex medical care. of what it means to be than many people a physician.” She feels realize,” said Tofte. that the providers at Rumsey’s dedication to the Project Care clinics specializing in care for provide exceptional the homeless stayed with Tofte and inspires care with limited resources. Individual her to help those in need. clinics work very hard to find follow-up care

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. 1. When I purchase any product for my home I am 2. All of the toxic substances in my home are stored always aware of whether or not it contains poisons. in child-proof containers. 60

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4. I am aware of the symptoms of accidental poisoning.

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3. I have an emergency plan in place in case of accidental poisoning in my home.

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Minnesota Health care new June 2015

Agree

No Disagree Strongly opinion disagree

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5. All of the medications in my home are securely protected from accidental (or intentional) use by children.

50

Strongly agree

Strongly agree

Strongly agree

Agree

No Disagree Strongly opinion disagree

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


Minnesota

Health Care Consumer Association

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

SM

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

www.mnhcca.org

Join now.

“A way for you to make a difference� 25 MINNESOTA HEALTH CARE NEWS 33

June 2015 Minnesota Health care news

NOVEMBER 2012


Chiropractic

Torque Release Technique New potential for childhood anxiety By Tye Moe, DC

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orque Release Technique (TRT)—a drug-free, noninvasive neurological chiropractic approach—may offer hope for children suffering from anxiety, nervousness, depression, or attention deficit hyperactivity disorder (ADHD).

The role of brain chemistry When children feel anxious, nervous, or can’t sit still, many parents take an “outside-in” approach. It is only natural to tell your child that everything is going to be all right, that they should sit still and behave, or that that they can discuss their problems whenever they like. But there is often another piece to the puzzle. While many assume that our brain controls our emotions, it is now known that our body also plays a pivotal role. Four natural body chemicals—dopamine, serotonin, oxytocin, and endorphins— elicit feelings of well-being when they are released in the brain, and can affect both feelings and behavior. By working with the body’s own natural release of “feel-good” brain chemicals such as dopamine, TRT may help some patients to achieve a state of calm and focus, allowing for optimal growth and learning. Some of our young patients who were challenged with anxiety, nervousness, depression, and ADHD felt more relaxed and had a sense of calm and peace after chiropractic adjustments. For example, one mother reported a significant change in her seven-year-old son’s ability to follow his teacher’s instructions as well as progress with his ADHD. In class, her son is supposed to fill out a chart every day of all the things he is supposed to do. Before our care, he would have a few boxes filled in, but the majority would be blank. After treatment, his teacher noticed he was consistently filling in the majority of his chart; she reported that he was calmer and able to focus better. In his earlier school assessment he was diagnosed with “extreme ADHD.” He was later retested and found to “barely qualify” as needing help.

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Minnesota Health care news June 2015

The stress factor How does TRT make such an impact? Its developer, Jay Holder, DC, and pharmacologist Candace Pert, PhD, both write that when the spine is not working properly, the body is unable to create the dopamine and other brain chemicals that the brain desires. They write that many of these brain chemicals are actually made along


the spinal cord. When the natural flow of these chemicals is hindered by spinal stress or trauma, Holder says, it results in “feelings of anxiety, anger, fear, or the craving of substances.” This is partly because the brain, in addition to being deprived of “feelgood” chemicals, is shifted into a state of “fight or flight” (also known as sympathetic dominance). Fight or flight is our body’s natural response to stress. If we were walking through the jungle and a tiger jumped out at us, our natural response would be to get our adrenaline flowing, our heart racing, our muscles active, and our mind scared. All this is a normal response to protect us and let our body fight…or decide to turn around and run (flight).

surface electromyography and thermal technology measures whether stress is present in a child’s spine, and, if it is, where it’s at and how much is there. Our “before” and “after” scans results from the young boy with ADHD showed nerve disturbance prior to treatment; after treatment, the followup scans showed that this stress had been alleviated.

TRT may help some patients to achieve a state of calm and focus…

Many kids experience everyday stress—doing homework, studying for exams, trying to make friends, dealing with relationships, playing sports, or completing projects— that can trigger the fight or flight response. Parents sometimes sense these stress factors, but often just believe that everything is going fine until they find that their child seems to stress out much more easily than other children do.

Conclusion TRT complements many behavioral approaches such as counseling, therapy, coaching, or medication. However, if there is a stress pattern in the body that keeps recreating stress in the brain, a plateau is hit. This treatment helps the body feed calm into the brain on a regular basis, so the brain begins to feel more at ease and a new baseline is developed. Many parents appreciate knowing that not only are their children feeling better, but they actually are better as a result.

Tye Moe, DC, is owner of Whole Family Chiropractic, a clinic specializing in pediatric health and development.

These are the children who may benefit most from TRT. Just as outside stress can cause the brain to feel overwhelmed and nervous, so can internal stress. Tension along the spine, while decreasing the operation of dopamine and other chemicals, can also shift our brain and nervous system into the fight/flight response. This means the brain may be on edge even though everything “should be” fine. How TRT works We first identify where tension along the spinal cord is interfering with the production of brain chemicals and is causing stress in the brain. By taking stress off the spinal cord, the body begins to utilize more of its natural chemicals. This natural, drug-free approach allows the body to do what it is innately designed to do. By optimizing brain and nervous system function, body function is also optimized for many patients. Children often experience better sleep, improved digestion, and a stronger immune system. One mother said that after her son’s first adjustment, “I had to check on my child three times last night to make sure that he was still breathing because he was sleeping so soundly!” Other parents reported that their children would get colds that would last for weeks; after care, they reported fewer colds of shorter duration. TRT does not involve the twisting, turning, popping, or cracking often associated with chiropractic. Instead we use a gentle, yet very specific input into the nervous system with an FDA-approved instrument called the Integrator, a handheld device that automatically reproduces the standard toggle recoil chiropractic adjustment at a speed of 1/10,000th of a second. The child gets to lie or sit (or play with toys), and feels only a mild tap. To assess whether a child would benefit, we perform noninvasive diagnostic scans using The Insight Millenium system. Originally developed to measure spinal conditions of astronauts in flight, this

Minnesota Optometric Association

Doctors on the frontline of eye and vision care Did you know? • Diabetic retinopathy can be controlled and diabetic patients need regular eye exams to maintain vision and good eye health. • Diabetes Type ll can also cause vision changes. • Glaucoma must be diagnosed in early stages in order to prevent vision loss. • All children entering school need a comprehensive eye exam, because vision screenings do not detect a number of eye disorders. • To maintain eye health, everybody from babies to boomers to older adults needs a regular eye exam by a family eye doctor. To locate an optometrist near you and find comprehensive information about eye health visit http://Minnesota.aoa.org June 2015 Minnesota Health care news

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Allied Professions

Unionizing home health care

How both providers and patients benefit By Sumer Spika

T Telephone Equipment Distribution (TED) Program

his past August, I was one of thousands of home care workers who voted in the largest union election in Minnesota history to form our union with SEIU Healthcare Minnesota. This vote was a historic moment in the fight that we are still waging to improve the home care field for both workers and the seniors and people with disabilities that we serve.

Do you have trouble using the telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.

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

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

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Minnesota Health care new June 2015

My story I had over 10 years of experience working in health care when a family I knew experienced a tragic loss. As a result, I ended up becoming a home care worker for the first time for a young girl named Jayla. Jayla’s dad was the main caregiver for her until he passed away in December 2008. Jayla’s mom, my friend Sarah, was left caring for a special-needs child on her own, and desperately needed help. I saw a little girl who deserved to be able to spend her time at home, not in an institution. I knew that if I cared for Jayla she could remain at home. I had no idea what challenges awaited me as a home care worker though! Jayla was born with pulmonary hypertension and a genetic disorder called Opitz syndrome. She is also deaf. She requires breathing treatments and thickened liquids, and needs help eating, toileting, and performing many other basic activities that require support every single day. I have a strong desire to care for others, and I know that it is beneficial for people to be able to stay in their homes while receiving the care they need. It gives the person being cared for a sense of dignity and independence. In the home care workers’ campaign that I have come to lead over the last couple of years, we want both home care consumers and the workers who serve them to be able to live the lives they choose. When I first started caring for Jayla, I was offered benefits such as health insurance and vacation time. But over the past few years, my pay has been cut, my vacation time taken away entirely, and the health insurance offered is impossibly expensive and only covers catastrophes. I no longer have the option of taking a day off because I can’t afford to lose the pay. When I gave birth to my daughter last year, I had to return to work the day after I got out of the hospital, even though I’d had a C-section. Forming a union My story is all too familiar to the tens of thousands of home care workers in Minnesota, and it is why we fought for and won the right


to vote on forming a union in 2013. A resounding majority of workers voted to form a union in August 2014. We have reached a tentative agreement with the state. The contract, which was ratified by members and now needs to be ratified by the Minnesota Legislature, makes many important gains for home care workers. We will go from zero to five days of paid time off, have a dedicated training fund, have the pay floor raised to $11 per hour, and finally have a voice on the job. In other states with established home care unions, increases in pay, benefits, and training have led to less turnover, more stability, a better prepared workforce, and higher quality care.

What our union means Eight other states have established home care worker unions, and over the years they have seen their pay and working conditions improve. Consumers also have reaped the benefits of having a more stable, professional workforce. When Illinois home care workers first organized in the 1980s, many of the workers made $1 an hour; now the minimum wage for the state’s home care workers is over $13. In the state of Washington, many union workers are now making $15 an hour. And in multiple states, home care workers have won affordable health insurance. We are confident that as workers see the gains we are bargaining for, we will see a decrease in the incredibly high turnover rate that plagues our field here in Minnesota.

We want to make sure that our work is “invisible no more!”

Everyone who has looked into our growing long-term care system understands that home care offers not just independence and quality of life, but huge taxpayer savings, compared to nursing homes or other institutional care. And in Illinois alone, Attorney General Lisa Madigan has reported that the reduction in turnover that occurred when home care workers won better pay and benefits through their union has saved the state over $600 million. How the union affects home care consumers Home care consumers (people with disabilities and seniors who receive in-home support services through Minnesota’s Medical Assistance program) have been an important and leading part of our fight from the very beginning of our campaign to form a union. Their stories have informed our policy and contract demands, and have moved legislators to understand that low pay and no benefits for home care workers creates instability and constant challenges in the lives of home care consumers.

The recent U.S. Supreme Court ruling in Harris vs. Quinn made home care unions “open shops.” Every one of the home care workers in our bargaining unit will receive the benefits of the contract, but only workers who have signed cards will pay dues and be members. We already have thousands of members who have signed cards to be part of the union, and our support level has remained high from workers and consumers at every step of this campaign. As workers talk to each other and recognize the systemic problems facing our field, they get fired up about supporting and joining our union. MSA - MN Healthcare July 2013.pdf

Unionizing home health care to page 33

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The bill we advocated for and passed at the State Capitol in 2013 explicitly maintained consumers’ rights to hire and fire their home care workers. While pay and benefits are set by the state, consumers need control over their own care. We were proud to have home care consumers join us in pushing for our right to organize, and we continue to include consumers in leadership roles as we negotiate our first contract. Many people end up taking care of family members out of necessity. If home care workers miss work because they can’t afford to take the bus or leave for a better paying job, family members may be forced to step into the caregiver role to prevent their loved ones from entering an institution. The same situation occurs if a consumer has only six or eight hours of care available per day, but needs more than that to live independently. Often, these family caregivers end up working 24 hours a day, leave jobs with benefits, and become underpaid caregivers. If the home care profession was compensated in a way that made sense, given the importance of the services we provide to seniors and people with disabilities, then consumers would have more stability in their care. Families would know that the workers caring for their loved ones will not only be there every day, but will have a deeper knowledge of the care their clients need. June 2015 Minnesota Health care news

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Women’s Health

Well-Woman

exams An important part of maintaining health By Jon S. Nielsen, MD, FACOG

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ecent controversy about the value of the “well-woman exam” or annual exam has left many women confused about what is wise, what is necessary, and what is covered by insurance. Medical societies, physicians, opinion leaders, and media outlets differ greatly in their recommendations and reports to consumers. I hope to add clarity to aspects of the controversy and to give practical advice about this preventive health care tool.

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Minnesota Health care news June 2015

A historical perspective The annual well-woman evaluation is a time-tested and accepted health care routine. John C. Jennings, MD, president of the American College of Obstetricians and Gynecologists (ACOG) summed up the College’s recommendations in a July 2014 news release: “We [ACOG] continue to urge women to visit their health care providers for annual visits, which play a valuable role in patient care. An annual well-woman visit can help physicians [sic] to promote healthy living and preventive care, to evaluate patients for risk factors for medical conditions, and to identify existing medical conditions, thereby opening the door for treatment. Annual well-woman visits are important for the quality care of women and their continued health.” The annual exam usually evaluates the health of the heart and lungs, breast tissue, abdomen, and female organs. The examination of the female organs is known as the pelvic exam. Patients understand that the screenings and exams are intended, in part, to identify unrecognized conditions or diseases that may have no symptoms. Provider-patient discussions about quality of life include lifestyle counseling about nutrition management, smoking cessation, exercise, breast health, sexually transmitted diseases (STDs), contraception, osteoporosis prevention, and domestic abuse. This can catalyze discussion about how often and when certain exams should occur. Annual exam questioned A July 2014 article in the American College of Physicians’ Annals of Internal Medicine may have led some women to question the value of annual exams. The article led to widespread media reports and opinion pieces about the value of the annual exam; some of the coverage suggested that routine pelvic exams caused more harm than good. Our local StarTribune newspaper furthered the controversy in a July 1, 2014 article entitled, “Mpls. VA Research: Most Women can Skip Pelvic Exams.” The Annals article suggested that pelvic exams may lead to unnecessary testing and surgery, and that women avoid preventive


evaluations because the pelvic exam is so unpleasant and painful. It also stated that the American College of Physicians “recommends against performing screening pelvic examinations in asymptomatic, nonpregnant, adult women (strong recommendation, moderate-quality evidence).” What was the widespread conclusion among many women as a result of this article and the subsequent news coverage? Many concluded, “I may not need an annual exam.” Yet, while the article suggested that annual exams had no value, it jumped to the conclusion that they shouldn’t be performed. This conclusion is without a sufficient evidence base in the literature. Further, the harm that comes from studies such as this one leads to an unfortunate outcome: women are dissuaded from seeking preventive care and given a reason to avoid these necessary visits.

pelvic exam discounts the benefits of early detection of many noncancerous gynecologic conditions. The annual exam also allows providers to help women remain healthy. If the guideline is valuable only for women who experience no symptoms of a possible condition (in other words, are “asymptomatic”), it puts the burden on the patient to decide what “asymptomatic” really means. Is a woman who has significant cramping with her menstrual period “asymptomatic”? Are women with vaginal discharge or premenstrual changes in bowel habits “symptomatic”? The provider can help the patient decide what is “normal.”

Much progress has been made in understanding both the natural history and cause of cervical cancer.

The true value of the annual and pelvic exams Throughout my 35 years of obstetrics and gynecology practice, it has been my opinion that there is true value in the annual wellwoman exam. Why? The pelvic exam, which includes examining the vulva, vagina, cervix, and uterus, can find “hidden” disease otherwise not discoverable. The concept that there is no value to the

In the next issue... Your Guide to Consumer Information

• Spleen Health • Carpal Tunnel Syndrome

Many women also expect the pelvic exam as part of their well-woman annual exam, and are comforted when they hear, “your female organs are normal.” I find this especially true for the ovaries, for which there is such a cancer fear.

A word about the Pap smear Much progress has been made in understanding both the natural history and cause of cervical cancer. The known relationship of the human papillomavirus (HPV) to cervical cancer has enabled Well-Woman exams to page 32

The Best Choice for Women’s Health Care V Low- and high-risk obstetrics, including older moms-to-be.

V Menopause Clinic, including management of peri-menopause.

V Certified nurse midwifery.

V Center for Urinary and Pelvic Health, including urodynamics (urinary leaking evaluation).

V Gynecologic care, including well-woman screenings and in-office procedures.

V Nutrition and wellness consultations.

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June 2015 Minnesota Health care news

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Well-Woman exams from page 31

changes to the screening regimen. Data analysis supports adding HPV testing to the Pap smear test (co-testing) and using a three-year testing interval to achieve results that are nearly equal to annual testing. This recommendation has been increasingly adopted since 2002. A newer option for cervical cancer screening, forwarded since 2012, consists of co-testing Pap and HPV at five-year intervals. As before, this option has been increasingly adopted. There are several notable points: This cervical cancer screening occurs as part of the well-woman annual exam. The annual exam occurs yearly; the Pap smear from yearly to five years. Too, while the change of screening interval from yearly to every three years has little apparent increased risk, going to a five-year interval has much less supporting data. Other than financial, what are the benefits of a five-year screening regimen

when balanced against the potential increased cervical cancer risk? Because of the remaining uncertainty of risk between these screening regimens, it is important to continue to allow the patient and provider to make a decision about frequency of cancer screening based on individual medical history and lifestyle. Conclusion The annual well-woman visit, with the co-occurring pelvic exam, and a Pap test with HPV analysis, are all valuable components of preventive health care. In spite of reports to the contrary, the major medical societies and most physicians still recommend these exams and screenings as part of a well-woman health routine.

there is true value in the annual well-woman exam.

Jon S. Nielsen, MD, is a fellow of the American College of Obstetrics and Gynecology. He practices with Oakdale Ob-Gyn, a division of Premier Ob-Gyn of Minnesota.

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Minnesota Health care news June 2015

Do You Suffer from 3 to 8 migraineS per month? If so, consider joining Samurai–a clinical study to assess a potential new migraine medication for people like you. We’re looking for people over 18 years of age to take part. We’d especially like to hear from migraine sufferers with at least one of the following cardivascular risk factors (But aLL migraine sufferers are welcome to contact us): • High blood pressure • High cholesterol • A smoker • Overweight • Diabetes

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Unionizing home health care from page 29

Even before we won the right to vote on forming a union, two extreme anti-worker lobbying groups filed federal lawsuits to stop us. However, we are confident our union will not be weakened by these outlandish attacks. Both in Minnesota and across the country, anti-union groups recruited a handful of home care workers to use in their attacks on workers’ collective bargaining. But that has not stopped workers and consumers from coming together to improve the conditions in our field. We don’t expect any of the attacks to derail our movement, especially as we are able to see gains made through bargaining our first contract. The future outlook Many of us have been involved in this struggle for more twists and turns than we care to remember, but we have remained unwavering in our belief that we will win this fight to improve our industry. Our goal has remained unchanged from the first days of this campaign over a decade ago: We want to make sure that our work is “invisible no more!” We know from other states that better pay and working conditions leads to more stability, and we fully expect that to happen in Minnesota as well. Especially when we consider the coming age wave, and the fact that home care work is projected to be the second fastest growing job in the country for the next couple of decades, we don’t feel like we have much of a choice but to win this battle. Home care consumers will attest to the challenge of finding sta-

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ble care, and as baby boomers age and want to stay in their homes, these challenges will only compound. Many seniors and people with disabilities would already say we have a crisis, but this will only spread in future years if we don’t find a way to respect and invest in home care work. Most people want to stay in their homes, and that saves money for the state compared with long-term care facilities. It is a win-win situation. For myself and other home care workers, we want to be able to continue to do the work we love, yet it is imperative that we are able to provide for our own families. I’ve seen too many wonderful caregivers leave the field to do other work, not because they were not talented or caring, but because they couldn’t afford rent or time off when they were sick. It has been a powerful experience for home care workers to come out from the shadows and talk to each other, recognizing that the daily challenges we face are frighteningly common. We know our first contract won’t change the industry overnight, but we know we will be moving in the right direction. We appreciate all of the people who work hard in the medical field, and we simply hope the important role home care workers play in supporting millions of people across the country will finally be recognized and compensated fairly here in Minnesota. When at long last this happens, both home care workers and the people they serve will finally be able to live the lives they choose. Sumer Spika is a home care worker and executive board member for SEIU Healthcare Minnesota.

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June 2015 Minnesota Health care news

33


Mental illness and our youth from page 15

This data is congruent with the overall prevalence of mental illness in the United States, with the Centers for Disease Control and Prevention ranking ADHD (6.8 percent) and behavioral or conduct problems (3.5 percent) as most common. Anxiety disorders are reported to affect 0.3 percent of children ages three to 17 and depression to affect 2.1 percent. The most common suggestion was a change in the dosage of medications. Oftentimes the dose being prescribed was simply too low to have an effect. Therapy was also recommended in almost every case where a therapist was not currently involved in treatment.

Conclusion The Psychiatric Assistance Line has provided valuable clinical expertise that has empowered primary care providers to treat psychiatric conditions in a timely and cost-effective manner. When primary care providers are able to manage behavioral health cases in the primary care setting, they can prevent the child and family from having to wait for an appointment with a child and adolescent psychiatrist who may already be overwhelmed with the most complex patient cases. The total costs for supporting this service across the entire state, including administration, technology, outreach, and clinical time is now available for just 34 cents per child in Minnesota. The results that are derived from successful psychiatric consultation to primary care are invaluable. PAL has provided services to 74 primary care providers in 41 clinics in the second half of 2014.

Child and adolescent psychiatrists in Minnesota number just 75.

Every CAP consultation is aimed at supporting the primary care provider’s treatment of the patient in their outpatient setting. Surveys are sent to pediatricians who have used the service and the feedback is very positive, with 100 percent of the respondents stating that the consultation was helpful, and 98 percent stating that their level of managing psychiatric conditions has increased as a result of contacting PAL.

Todd Archbold, LSW, MBA, is a licensed social worker, the chief development officer of PrairieCare, and the practice manager of PrairieCare Medical Group.

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Minnesota Health care news June 2015


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

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for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — ® Add-on to Metformin Victoza + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) ®+ ® None Insulin detemir + Continued Victoza Add-on to Victoza Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Rosiglitazone + Placebo + Add-on to Glimepiride Victoza® + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

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

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


®

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

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

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

b

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

The change begins at VictozaPro.com. Indications and Usage

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

Important Safety Information

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

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

December 2013

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Mnnesota Healthcare News June 2015  

A monthly journal of healthcare consumer advocacy. Written by doctors for patients.

Mnnesota Healthcare News June 2015  

A monthly journal of healthcare consumer advocacy. Written by doctors for patients.

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