January/February 2014 • Volume 12 Number 2
Why do I feel cold? Gloria R. Leon, PhD
Buying medicine online David Hoang, PharmD
Winter exercise pays off Jamie Peters, MD
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January/February 2014 • Volume 12 Number 2
News
18 20
Calendar
People
Perspective Robert M. Jacobson, MD, FAAP MN Chapter American Academy of Pediatrics
10 QUESTIONS Gloria R. Leon, PhD University of Minnesota
Rheumatology Raynaud’s phenomenon
By David Ridley, MD
Take Care
Winter exercise pays off
22 24 28 30
Research
Post-traumatic stress disorder By William H. Frey II, PhD
Policy
Back pain
By Bret Haake, MD, MBA
insurance
Better together
By Russel J. Kuzel, MD, MMM
Health professions
Adolescent medicine By Naomi Duke, MD, MPH, FAAP
Pharmacy
Buying medicine online By David Hoang, PharmD, Jason Varin, PharmD, and Craig Else, PharmD
By Jamie Peters, MD
Drug Class
Bisphosphonates y Erin Kraemer and B Sarah M. Westberg, PharmD, BCPS
MINNESOTA HEALTH CARE ROUNDTABLE
Editor’s note Staff retirements and related changes created a production delay with this edition. As a result, the January and February issues have been combined.
Post-acute care Fixing cracks in the system
Thursday, April 17, 2014 1:00–4:00 PM, Symphony Ballroom Downtown Minneapolis Hilton and Towers
Background and focus: Post-acute care is becoming an increasingly important component of health care delivery. It is also becoming increasingly community-based. Medical advances are dramatically expanding the range of access to these services and, at the same time, creating a larger number of problems providing them. Choppy access to electronic medical records and ensuing medication management complications, as well as problems with care team coordination, can impede the goal of improving outcomes while lowering costs.
Objectives: We will discuss the evolution of post-acute care and illustrate the dynamic potential it holds. From the hospital to the physician to skilled nursing, rehab, and home care, we will present perspectives from across the care continuum. We will investigate communication problems between care team members and present potential solutions. We will examine how elements of health care reform like ACOs and insurance exchanges can drive both improvement in and higher utilization of post-acute care. We will discuss the tools that are necessary for post-acute care to reach its full potential. Panelists include: • Krista Boston, JD, Director, Minnesota Board on Aging • Rahul Koranne, MD, MBA, FACP Executive Medical Director, Bethesda Hospital • Dawn Simonson, MPA Director, Metro Area Agency on Aging, Inc. • Kari Thurlow, JD Senior Vice President, Aging Services of Minnesota • Carol Zindler, Vice President, Client Experience, Caremerge Sponsors include: • Aging Services of Minnesota • HealthEast Care System • MN Association of Area Agencies on Aging • Senior LinkAge Line
Publisher Mike Starnes | mstarnes@mppub.com Senior Editor Janet Cass | jcass@mppub.com ASsociate Editor Stacey Bush | sbush@mppub.com Art Director Alice Savitski | asavitski@mppub.com Office Administrator Amanda Marlow | amarlow@mppub.com Account Executive Linda C. Johnson | ljohnson@mppub.com Account Executive Iain Kane | ikane@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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January/February 2014 Minnesota Health care news
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NEWS
MNsure Exec Director Resigns, Interim CEO Appointed April Todd-Malmlov resigned as executive director of MNsure, the state’s health exchange, at a closeddoor meeting with the program’s executive committee on Dec. 17, 2013. The committee named Scott Leitz, Minnesota’s assistant commissioner of health care, as MNsure’s interim CEO and launched a national search for a candidate to fill the position permanently. Todd-Malmlov’s resignation followed ongoing problems with MNsure’s website and implementation, as well as increasing pressure from consumers, legislators, and Gov. Mark Dayton. “The recent problems some have experienced with MNsure are completely unacceptable,” said Dayton. “I am hopeful that this new leadership will lead to their swift resolution.”
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The latest issue with the health exchange arose in December. Minnesota health insurance companies expressed concerns that they were not receiving complete or correct enrollee information from MNsure. They said delays in receiving information could prevent people who had enrolled in a health care plan from having coverage as of Jan. 1, partially due to a flaw in the website’s design. “We acknowledge that people have struggled with the website,” said Leitz. “There have been times that people have been frustrated. People have had long wait times with the call center, and these are operational issues that will need to be addressed.” Leitz has been assistant commissioner of health care at the Minnesota Department of Health since 2011. In his 20 years of health care and public health experience, Leitz has been responsible for overseeing the state’s Medicaid program and MinnesotaCare eligibility and benefits.
Minnesota Health care news January/February 2014
“He’s got the skills that are needed at this point in time,” said Julie Brunner, executive director of the Minnesota Council of Health Plans. “And he understands that if you’re going to solve a problem, you need to understand all the stakeholders’ concerns around a particular issue.” Minnesota is one of 15 states that opted to build a state health insurance exchange program, along with the District of Columbia, and is not the only exchange to undergo major leadership changes. The director of Maryland’s health exchange stepped down recently; the head of Hawaii’s announced her resignation in November; and the leader of Oregon’s took a medical leave of absence in December as state officials reviewed his job performance due to delays in that state’s enrollment system.
Number of Uninsured Children Drops by 16,000 in Minnesota The number of uninsured children in Minnesota dropped by 16,000 between 2010 and 2012, reports a study conducted by Georgetown University’s Center for Children and Families, Washington, DC. This was the number predicted by state officials when Gov. Mark Dayton and legislators broadened access to MinnesotaCare, the state’s subsidized health insurance program, in July 2013. The Star Tribune reported that officials with the Children’s Defense Fund–Minnesota said the decline can’t be entirely attributed to the change in MinnesotaCare access, but they believe it contributed to the progress in reducing the number of uninsured children. “While we can’t show the direct correlation, we know that expanding and streamlining access to public health care programs
decreases the number of uninsured children and ensures more children get the care they need,” said Elaine Cunningham, outreach director for Children’s Defense Fund– Minnesota. Minnesota’s low uninsured rate in adults has often been among the five lowest in the U.S. However, the state has not fared so well in rates of uninsured children. The Georgetown Center said that further declines in those rates can be expected as the Accountable Care Act and other health reforms take effect.
Children’s Unveils New Neuroscience Unit in St. Paul Children’s Hospitals and Clinics of Minnesota opened a new neuroscience inpatient unit at its St. Paul location late last year, dedicated to the care of epilepsy and neurosurgery patients. The new Karen and George Benz Family Pediatric Neuroscience Center was built because the health system is experiencing a growing need for these services. In the last year, Children’s provided neurological treatment to more than 1,800 patients, performed 455 brain surgeries, and cared for 486 children that had seizures. “Over the last decade, we’ve seen a steady increase in traumatic brain injuries, pediatric brain cancers, and premature babies with neurological issues,” said Phil Kibort, MD, chief medical officer at Children’s.
Medica Offers New ACO Products Medica has announced two new accountable care organization (ACO) products, Inspiration Health by HealthEast and Medica, and North Memorial Acclaim by Medica. The products are built around specific provider networks and are available as coverage for individuals and families that do not have health insurance through an employer. Inspiration Health aims to reach residents in the east metro area and includes access to HealthEast Clinics, Woodwinds Hospital, St. John’s Hospital, St. Joseph’s Hospital, and Bethesda Hospital.
North Memorial Acclaim is available to people in the north and west metro areas and covers services at Maple Grove Hospital, North Memorial Medical Center, Amplatz Children’s Hospital, and a network of primary, specialty, and urgent care clinics across the metro area.
SMOKERS & EX-SMOKERS
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According to officials, both products may be purchased as a copay plan, as an HSA (health savings account) plan, or as catastrophic coverage. They are available through MNsure, Medica, or an insurance broker, but subsidies will be available only if coverage is paid for through MNsure.
• Are you a smoker or ex smoker who is at least 40 years of age? • Do you experience difficulty breathing/ shortness of breath? and/or • A chronic cough or wheezing? If so, you may qualify to participate in a clinical trial.
Hospitals Respond to Increase in Violence
Study related medical care at no cost, Study related medication at no cost Compensation for time and travel
Minnesota hospitals are putting new safety protocols into effect and educating health care employees in response to a growing number of threats against hospital workers. Death or serious injury of a staff member resulting from physical assault are among the top 29 preventable adverse events that hospitals and licensed ambulatory surgical centers are required to report to the Minnesota Department of Health (MDH) as part of an annual safety-improvement strategy. Eight incidents have been reported to MDH since 2005, but officials say that many assaults and threats go unreported, often due to a hospital employee’s compassion toward a patient.
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“It could be the black eye or injury that does not rise to the level of missing work,” said Diane Rydrych, MDH director of health policy. State safety officials say that the problem has spread to more areas of health care than emergency rooms and mental health units, historically the settings for such incidents. Assaults have been reported recently in maternity wards and pathology labs. Doctors, nurses, and mental health workers, collectively, report 6.5 assaults per 10,000 workers, according to 2011 federal workplace injury data. This rate is four times higher than the overall U.S. rate of workplace assault. News to page 6
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News from page 5
CentraCare Health System in St. Cloud began a safety training program in 2010 after a string of incidents, including one in which a patient threw a computer at nurses. The health system is asking employees to complete an eight-hour training session by summer 2014. Hennepin County Medical Center (HCMC) is conducting active-shooter drills in a paintball facility designed to look like a hospital unit. This allows workers to practice responding to threatening scenarios. Stinging paintball pellets create a sense of urgency for staff participants to help them learn when to fight, hide, or run, said Bill Leone, HCMC security investigator. The health care organization also trains staff in a practice known as verbal judo, a way to communicate with angry people that calms them and prevents violent behavior, as well as in other safety protocols such as positioning oneself in a room in such a way as to leave an
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escape route.
Dayton: Board of Nursing “Asleep at the Switch” Gov. Mark Dayton said late last year that some members of the Minnesota Board of Nursing have told him they do not feel qualified to question the board’s staff during disciplinary review cases for nurses accused of misconduct. He called the board “asleep at the switch” and said that dramatic changes may be necessary to change its culture. Dayton’s remarks followed growing concern about the board’s disciplinary practices, after a recent analysis by the Star Tribune revealed that many nurses who should have been disqualified for crimes such as criminal sexual misconduct, assault, and fraud were still actively licensed. Legislative auditor James Nobles said he was preparing for a
Minnesota Health care news January/February 2014
comprehensive investigation of the board, with support from Dayton and other lawmakers. Once a legislative commission approves the audit, Nobles and his office will review the board’s disciplinary practices and how they compare to those of other state boards and to national standards. The audit would likely start in March and be conducted by a team of two or three people over the course of six months, Nobles said. Dayton said he will wait until the audit is completed to decide what corrective steps to take.
NAMI Gives Awards For Mental Illness Awareness Efforts HealthPartners and Regions Hospital received the National Alliance on Mental Illness (NAMI) of Minnesota’s anti-stigma effort of the year award at the NAMI annual conference on Nov. 16 in St. Paul.
The award recognizes the organizations for their efforts to reduce stigma and barriers around mental illness that lead to discrimination and shame. Regions Hospital built a new mental health building with input from people who use its services and held special trainings for staff to create a therapeutic environment for patients. In addition, the hospitals launched the MakeItOK campaign, which promotes community awareness and understanding of mental illness through television, radio, and print ads. “The goal is to make it OK to talk about mental illness and to help people to know what to say when someone does share that they or a family member has a mental illness,” said Sue Abderholden, executive director at NAMI. MakeItOK campaign leaders helped create a documentary series featuring personal stories for Twin Cities Public Television.
People Bjorn Engstrom, MD, has joined Consulting Radiologists, Ltd., Twin Cities, as a board-certified radiologist with a specialization in interventional radiology. Engstrom earned a medical degree from Dartmouth Medical School in Lebanon, N.H. He completed a residency and fellowship in vascular and interventional radiology at Duke University Medical Center in Durham, N.C.
Anna Hatchett, MD
Anna Hatchett, MD, board-certified in surgery and surgical critical care, has joined Essentia Health–Duluth Clinic as a trauma surgeon. She earned her medical degree from Case Western Reserve University, Cleveland; completed a general surgery residency at University Hospitals Case Medical Center, Cleveland; and a fellowship in surgical critical care at East Carolina University in Greenville, N.C.
Meysam Kebriaei, MD, board-eligible in neurosurgery and pediatric neurosurgery, has joined Children’s Hospitals and Clinics of Minnesota. He completed medical school and a neurosurgery residency at the University of Nebraska Medical Center, Omaha, and a fellowship in pediatric neurosurgery at Emory University, Atlanta.
PUT THE SQUEEZE ON HIGH BLOOD PRESSURE If you have diabetes, controlling your blood pressure can help protect you from heart attack, stroke, blindness and kidney disease
• Track your blood pressure and share with your doctor • Medicines can make a difference... if you take them • Eat healthy and be active • Avoid salt Meysam Kebriaei, MD
Eric V. Larsson, PhD, Lovaas Institute Midwest, Minneapolis, has received the 2013 Provider Advocate of the Year Award from national advocacy organization Autism Speaks. Larsson was recognized for successfully advocating for autism health benefits in Minnesota and for his career of dedication to people with autism. As executive director of clinical services at Lovaas, he provides early intervention services for families of children who suffer from severe behavioral disorders, including those on the autism spectrum.
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Minnesota Diabetes & Heart Health Collaborative
The Minnesota Diabetes and Heart Health Collaborative: Working together to keep you informed
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Chad Richardson, MD, has been named director of trauma services at Hennepin County Medical Center (HCMC); he had served as assistant director since 2008. Richardson graduated from the University of Minnesota Medical School, completed a surgery residency and a fellowship in surgical critical care at HCMC, and a fellowship in renal transplant at the Karolinska Institute, Stockholm. Joining HCMC’s nephrology department is Connie Wang, MD, who graduated from Beijing Medical University in China. Wang completed an internal medicine residency at Michigan State University, East Lansing, and fellowship training in nephrology at Johns Hopkins University Medical Center, Baltimore. Previously, Wang was on the faculty at University of Kansas Medical Center, Kansas City. Richard Sharp, PhD, is the director of the new- Connie Wang, MD ly formed Mayo Clinic Biomedical Ethics Program, intended to help researchers, physicians, and patients address ethical questions brought about by advances in biology and medicine. The program includes bioethics research, institutional service and bioethics consultation, education, and bioethics programming and outreach. Sharp previously served as Cleveland Clinic’s director of bioethics research and as co-director of the Center for Genetic Research Ethics and Law at Case Western Reserve University, Cleveland. January/February 2014 Minnesota Health care news
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Perspective
Newborn screening Destruction of 1 million newborn blood spots endangers Minnesota children On January 13, the Minnesota Department of Health (MDH) announced it would begin destroying all newborn blood spots it received before November 16, 2011. Destruction is mandated by a Minnesota Supreme Court ruling in favor of 21 families who sued the state over medical privacy. Robert M. Jacobson, MD, FAAP (Fellow of the American Academy of Pediatrics) MN Chapter American Academy of Pediatrics (MNAAP)
Dr. Jacobson is the president of the Minnesota Chapter of the American Academy of Pediatrics (MNAAP). Board-certified in pediatrics, he is a professor of pediatrics at the Mayo Clinic, Rochester, where he is on staff in both the Department of Community Pediatric and Adolescent Medicine and the Department of Pediatric and Adolescent Medicine. The MNAAP represents nearly 1,000 pediatricians and pediatric providers statewide and is committed to improving the health of all infants, children, and teens in Minnesota. For more information, visit www.mnaap.org/ newbornscreening.htm.
What are newborn blood spots? When a baby is born in Minnesota, a tiny amount of blood is collected from him or her and deposited as a spot on special paper. This blood is tested to determine if the baby has any of 50-plus diseases that can be detected at birth. One such disease is cytomegalovirus, the leading nongenetic cause of hearing loss in children. Genetic diseases are also detected by this testing.
Storage of blood spots and data assures proper diagnosis and timely follow-up for critically ill children. What this ruling means for parents and guardians is that their child’s doctor will no longer be able to contact MDH directly if the child’s test results are urgently needed after age 2. There will be no way to ensure families and providers have access to the results of the test or verify that testing indeed took place.
Saving newborn screening blood spots and test results is critical to saving lives.
Newborn blood spots were, until recently, stored for 18 years and used for follow-up testing to help physicians understand a child’s illness that may not have been detected at birth. They were also used to develop tests for additional diseases. What the ruling says Before the ruling in favor of the 21 families, blood spots could be stored by the MDH for 18 years. Under the new ruling, blood spots that test negative for disease must be destroyed within 71 days. Abnormal spots may be stored for two years before being destroyed, unless parents state in writing that they want spots saved until the child is 18. Drawbacks to the ruling: • I t can take longer than 71 days to confirm a diag-
nosis. Not all test results are known within 71 days, hindering physicians’ ability to diagnose.
•D estroying test results and positive blood spots by
a child’s second birthday can delay diagnosis and treatment if the child or a sibling becomes ill in the future.
•B lood spots and data provide the basis for qual-
ity control and new test development. MDH was recently forced to delay testing for severe combined immune deficiency syndrome (SCID) due to unavailability of blood spots. At least two babies annually typically test positive for SCID, and need immediate treatment in order to survive. Some SCID babies were almost certainly undetected during the delay due to the unavailability of blood spots.
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Ramifications The Minnesota Chapter of the American Academy of Pediatrics (MNAAP) is deeply concerned about the Court decision’s dramatic and dangerous impact on child health. Saving newborn screening blood spots and test results is critical to saving lives. Destruction of blood spots and data robs children and families of a tremendous, life-saving resource.
Minnesota Health care news January/February 2014
In addition to the destruction of older blood spots, MNAAP is deeply concerned about the new time frames for destroying infant blood spots and test results. Minnesota is the only state that destroys newborn screening results so soon after birth. Destroying blood spots at the arbitrary 71-day time limit can risk an infant’s health because it can take more than six months to confirm a diagnosis in some cases. Furthermore, destroying test results and positive blood spots at the arbitrary 2-year limit robs families of a diagnosis after re-analysis based on new discoveries that become apparent after the child ages or dies, or after an affected sibling is born. What’s next? Information collected through newborn screening has saved more than 5,000 lives. MNAAP will do everything in its power to reverse these changes, restore the program, and save as many babies as possible from unnecessary death, disability, and impairment. Because, while parents have the option to give permission to MDH to retain their baby’s blood spots for 18 years, this may not provide the benefits of testing for all babies. That’s suggested by results of “opt-in” policy outside Minnesota, which has resulted in parents from various demographic groups not consenting to 18-year storage. This limits the ability to identify genetic disorders that have racial or ethnic variations. Legislators need to act to restore Minnesota’s newborn blood spot program so it can save as many children as possible.
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This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation AMA PRA Category Credit Statement: AMA 1PRA Category 1 Credit Statement: Council for Continuing Medical Education through the joint sponsorship of the Minnesota Medical Association and Rainbow The Minnesota The Medical Association designates this designates training for this a maximum of 4a AMA PRA Category Credit s™. Physicians Minnesota Medical Association training for of 4 AMA 1PRA Category 1 Credits™. Physicians Health Initiative. The Minnesota Medical Association (MMA) is accredited by maximum the Accreditation Council for Continuing should claim only the credit with the extent with of their in participation the activity. in the activity. should claim commensurate only the credit commensurate the participation extent of their Medical Education to provide continuing medical education for physicians. AMA PRAContact Category 1Brianna.McMichael@rainbowhealth.org Credit Statement:
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January/February 2014 Minnesota Health care news
9
10 Q u e s t i o n s
Why do I feel cold? Gloria R. Leon, PhD Dr. Leon is a semi-retired psychology professor at the University of Minnesota, Twin Cities. She continues to be involved in research for NASA, directed toward maintaining astronauts’ thermal comfort during space walks. Leon also serves on NASA and National Academy of Sciences advisory committees, focusing on astronaut behavioral health and performance during long-duration space missions. Here, she is holding a prototype of the MACS-Delphi cooling/warming garment, still in research and development.
What does “thermal comfort” mean? According to official American and British standards for workers, thermal comfort is defined in terms of satisfaction with the thermal environment. In other words, it’s a subjective evaluation that the environment a person is in feels neither too hot nor too cold. How did you become interested in studying this subject? I have been conducting research on stress and coping in extreme environments throughout my academic career, with a particular focus on polar expedition teams as an analog for space missions. In the 1990s, I began working with Victor Koscheyev, MD, PhD, a Russian thermal physiologist at the University of Minnesota who had a great deal of experience in the design of spacesuits and protective clothing for other extreme environments. Through extensive laboratory research, we have collaborated on improving the thermal effectiveness and overall comfort of the NASA liquid tubing cooling garment that astronauts wear during space walks, as well as collaborating to improve the design of astronaut space gloves. (Dr. Koscheyev has since retired, but has an appointment as a senior research associate in the university’s Department of Housing, Design, and Apparel.) Please tell us about the temperature receptors in our skin. There are numerous separate receptors for heat and cold located below the skin surface. There are three to 10 times more cold receptors than heat receptors, depending on skin location. Sensory nerve fibers carry information from these thermal receptors to the central nervous system. The central nervous system, in turn, activates nerve fibers that carry nerve impulses to muscle groups. When there is a sudden change in skin temperature there is a burst of activity by receptor nerve fibers, followed by adaptation during which the fibers’ activity remains at a lower steady state or eventually stops. The areas of the skin that are most sensitive to temperature changes are the face, lips, and fingers, particularly the fingertips. Our own research showed that the very first response to cold is a change in finger temperature. Although there are individual differences, skin temperature above 91.4 degrees F typically provides a sensation of warmth; below 78.8 degrees F, a sensation of cold. What other areas of the body are involved in temperature regulation? The hypothalamus is a structure located deep within the brain. It functions as a thermostat to maintain internal body temperature at about 98.6 degrees F to protect the brain and internal organs of the body core. In cold conditions, the hypothalamus initiates processes to increase the body’s metabolic rate. This promotes heat gain and prevents further heat loss. An important thermoregulatory mechanism that is initiated by the hypothalamus is “shivering thermogenesis,” triggered when skin or core body temperature falls to a certain level. Shivering increases body metabolism and thus body heat production.
Photo credit: Bruce Silcox
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Minnesota Health care news
Can you help us understand the mechanics of how we feel cold, including the effect of wind and humidity/dampness? The sensation of cold is a combination of stimulation of cold receptors on the body surface, and the learned labeling of these sensations as “cool” or “cold,” depending on their intensity. It also results from the thermoregulatory mechanism that shifts warm circulating blood from the body periphery to the internal body to maintain core body temperature. This blood-shifting process begins at the fingers; blood vessels constrict, which diminishes blood circulation to this area. Wind accelerates body heat loss in the cold by removing warmth from the skin and dispersing warm air
January/February 2014
layers enclosed within insulating layers of clothing. Wind chill—the combination of low air temperature and air movement across the body—can result in the freezing of exposed skin tissue. We lose heat faster when conditions are humid or damp. Heat loss occurs through evaporative cooling to dissipate the dampness. Why do some people feel the exact same temperature differently? The experience of cold and warmth is determined by both genetics and environment. For example, Inuit and other indigenous populations living in Arctic environments are less susceptible to cold. Their genetically determined body configuration is rounded and dense, and includes a relatively greater amount of adipose tissue (fat layer) below the skin, which serves as insulation from the cold. There also is a physiological adaptation to living in an extremely cold environment for an extended period of time. However, with the seasonal changes in our Minnesota environment, the adaptation to the cold is basically psychological. We often respond to the first sensations of cold in late fall by labeling these feelings: “It’s cold out.” However, later in the season, we may become used to this sensation and no longer label it “cold.”
layer of body fat below the skin provides more insulation against the cold. What are some medical conditions that predispose someone to cold sensitivity? Several conditions are particularly associated with sensitivity to the cold: Raynaud’s phenomenon, hypothyroidism, anemia, and anorexia nervosa. NASA has given you two awards to date, “for the creative development of a technical innovation.” What can you tell us about this? In collaboration with Dr. Koscheyev, our research group at the University of Minnesota applied the concept of physiological design to develop a shortened liquid cooling/warming garment to be worn under the bulky space suit during space walks. Through extensive research in our laboratory, and with the help of graduate and undergraduate students working with us, we identified the areas of the body that are most effective in heat transfer. We then constructed the garment so that the plastic tubing through which cool or warm water circulates would cover only those body areas. Applying this strategy, we reduced the length of the existing garment and made it more energy efficient and comfortable. We also have worked to improve the heating system within the space glove worn by astronauts, again using physiological and anatomical principles of heat transfer.
There is no bad weather, only bad protective clothing!
How is cold tolerance affected by age and sex differences? Cold tolerance typically decreases with age, in part, because the resting metabolic rate in the cold is lower in older persons. Therefore, an older person’s body produces less heat energy than it did when that person was younger. Also, comparative studies have shown less vasoconstriction of older people’s blood vessels when exposed to cold air, resulting in a greater sensation of cold. Females typically tolerate cold better than males because females generally have a greater percentage of adipose tissue than males. This thicker
What do you do to stay warm during the winter? There is no bad weather, only bad protective clothing! We lose approximately 30 percent to 35 percent of our heat through the head and neck. I wear clothing layers, including a hat, gloves, and boots.
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January/February 2014 Minnesota Health care news
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R h e u m at o l o g y
Raynaud’s phenomenon Bothersome but treatable By David Ridley, MD
R
aynaud’s phenomenon is a condition that causes people’s fingers and toes to turn white or blue in response to stress and/or cold. Over time, the condition also can make nails become brittle and develop longitudinal ridges. The original description by nineteenth-century French physician Dr. Raynaud related a condition characterized by a tricolor change in a person’s skin color upon exposure to cold. Fingers would first turn white, then red, and, finally, blue. This was thought to relate to loss of blood flow to the affected area (white); the return of blood flow (red); and how long the area was deprived of oxygen (blue), which is carried by blood.
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Symptoms Fingers are more commonly involved than toes. An attack of symptoms usually starts in one or two fingers and then spreads throughout the same hand. Interestingly, the thumb is usually unaffected. The ears, nose, face, and other body parts exposed to cold are affected less often than are fingers or toes. Patients often experience discomfort, aching, numbness, clumsiness, and a “pins-and-needles” sensation in the affected area. Symptoms usually go away within 15 to 20 minutes after exposure to the provoking factor is removed. Risk factors It is estimated that 3 percent to 5 percent of the general population has Raynaud’s, with females more prone to developing this phenomenon than males. There is often a familial tendency toward this condition, which suggests that it may include a genetic component. I have found that patients can usually specify a temperature threshold that triggers their symptoms. This threshold is different for everyone. Some people only notice the condition when the temperature is below freezing. Others experience flare-ups in air-conditioning or when they’re in the freezer aisle of the grocery store. Even people who have not previously experienced sensitivity to cold may develop it if they relocate from a warm climate to a cold one. For example, a native of Australia who moved to Minnesota told me that it took her three years to adapt to Minnesota winters. During that time, she experienced cold hands during colder weather. Severity of this response improved during the three years, finally disappeared, and represented a normal response to the change in climate. Causes In people who have Raynaud’s phenomenon, blood vessels constrict more than normal and do not dilate well. Normally, blood vessels narrow in cold conditions and subsequently dilate to resume normal blood flow when conditions warm up. The blood vessels in the skin that react to temperature change in this way are called thermoregulatory vessels. These specialized blood vessels are controlled by the sympathetic nervous system, which is activated when we are nervous or upset. This explains why stress as well as cold can cause narrowing of vessels that leads to Raynaud’s symptoms.
Minnesota Health care news January/February 2014
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People who have Raynaud’s phenomenon without a related disease are said to have primary Raynaud’s. They rarely are significantly affected by symptoms and usually respond well to treatment. People who have what is called secondary Raynaud’s have another, secondary condition that affects their blood vessels. These people may have symptoms that are more severe, their attacks may last longer, and they may develop pain in or open sores on their fingers. Secondary conditions include systemic lupus, scleroderma, frostbite, vasculitis, abnormal clotting, and clumping of proteins that plug blood vessels.
Patients can usually specify a temperature threshold that triggers their symptoms.
Coping strategies A number of strategies can help prevent or diminish the severity of Raynaud’s symptoms. The most important thing you can do is to avoid cold temperatures, especially rapid changes from warm to cold temperatures. Dress appropriately. Techniques to keep the whole body warm include layering, using thermal wear, and wearing a heat-conserving hat. Winter gloves, chemical hand- and foot-warmers, and wool gloves and stockings will help keep toes and fingers warm. Increase circulation by placing hands or feet in warm water or a warm place, i.e., armpits. Rubbing hands and feet, and whirling arms and legs will increase circulation.
evening for four to five days, his or her physician will typically switch the time the patient takes the medication to morning. If a dose increase is needed, the increased dose is again given in the evening, along with the same warning to sit at the side of the bed for three to five minutes before rising.
Some patients need year ’round therapy, although many patients need periodic therapy depending on when their symptoms flare. Some need medication only from November to February, when the temperature is below 20 degrees. Many need therapy from October to March, when the temperature is below freezing. Those who need continuous therapy often need their dosage increased as the weather gets colder. Each person has a different threshold and therapy must be individualized. If a bigger dose is needed, the medication is slowly increased.
Reducing stress helps Many other therapies are available for Raynaud’s. Learning techniques to reduce or limit emotional stress can be very helpful in moderating symptoms. David Ridley, MD, is a board-certified rheumatologist who practices with St. Paul Rheumatology Associates.
Don’t smoke and avoid exposure to smoke, including secondhand smoke. Nicotine makes blood vessels constrict. Avoid these drugs. Decongestants, amphetamines, diet pills, and herbal supplements that contain ephedra make blood vessels constrict. Certain medicines used for migranes exacerbate Raynaud’s. Some experts recommend avoiding caffeine, but the relationship between caffeine and symptoms has not been completely substantiated. Postmenopausal women on supplemental estrogen experience more Raynaud’s than do their peers who do not take estrogen, but the impact of estrogen is currently unclear. Beta-blockers (blood pressure medicines that end in “lol,” such as metoprolol) were once thought to cause Raynaud’s but this theory has been disproven. On the other hand, beta-blockers do not reduce Raynaud’s symptoms. Avoid repeated trauma to fingertips (this does not include typing). Medication When conservative measures are ineffective at controlling Raynaud’s symptoms, the most common medications used are calcium channel blockers. These work by preventing blood vessels from constricting. The most common side effects of this medication are flushing, fluid retention and associated swelling (edema), headache, rapid heartbeat, and dizziness. Because calcium channel blockers can cause blood pressure to drop, dosage is usually begun at night. Patients are warned to sit at the side of the bed for three to five minutes before rising to avoid a sudden drop in blood pressure that could cause them to lose consciousness. After a patient has been taking this medication in the January/February 2014 Minnesota Health care news
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ta k e c a r e
humans are not designed to hibernate. The human body at every age needs to stay active year-round to optimize health.
Get off the couch! By Jamie Peters, MD
T
he short days of winter create a tempting scenario of curling up on the couch in front of the fire with a good book and a cup of hot chocolate with whipped cream. As appealing as this sounds, a steady diet of cozy restfulness leads to cardio and musculoskeletal deconditioning and other maladies. Unlike bears,
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Minnesota Health care news January/February 2014
Exercise as medicine It has been proven beyond any doubt that exercise is a powerful treatment and a successful preventative for many conditions, including type 2 diabetes; depression, anxiety, and other mental health conditions; osteoporosis; and cardiac-related conditions such as hypertension, coronary artery disease, and congestive heart disease. In addition to these benefits of year-round exercise, exercise to maintain core strength is extremely important as a way to help prevent injury to the anterior cruciate ligament (ACL). The ACL is one of four major ligaments that stabilize the knee joint. ACL ruptures and other knee and ankle injuries have become commonplace in sports involving quick turns, such as soccer, tennis, basketball, and football. Most ACL injuries actually occur without person-to-person contact. There are 250,000 ACL ruptures in the United States annually, at a cost of approximately $1.7 billion for medical treatment. Youth and ACL injury The true cost of ACL injury may be higher, since even after an ACL is surgically reconstructed, a very high percent of patients develop knee arthritis within 12 to 20 years. Exercising to prevent this injury in younger people is, therefore, important in order to prevent subsequent development of early-onset arthritis. The saying “An ounce of prevention is worth a pound of cure” is extremely appropriate for this condition. Females and ACL injury And it’s especially appropriate for females, since they are three times more likely than males to experience an ACL injury. Reasons proposed for this gender difference include the fact that the female hip creates a greater angle of the upper leg bone between the knee and hip; females typically have weaker hamstrings (big muscles in the back of the thigh) than males; and monthly changes in estrogen affect ligament strength. Preventing ACL injury These injuries need not be inevitable, however, and winter is a good time to do exercises that can help prevent them once spring comes and you’re participating in tennis or other sports activities. Many of these exercises are designed to enhance balance as well as to build strength in the gluteus and other core muscles. This improves control of knee motion and hence decreases the risk of injury to the
ACL and other joints below the knee. Yoga, pilates, and similar strengthening activities help maintain core strength and balance. However, as any good instructor will tell you, listen to your body and if something hurts during a specific pose or position, avoid it and practice an alternative pose. In addition, ACL prevention programs train people’s proprioception and help them learn how to land on their feet properly. Proprioception is the brain’s ability to sense the position of joints in space, and improving it helps people avoid falling. Preventing ACL injury, as well as enhancing general health, is promoted by year-round cross-training. This involves using different muscles by engaging in a variety of activities. Winter cross-training could, for example, include cross-country skiing, skating, and indoor sports such as basketball. Cross-training is most effective when used in addition to activities that promote heart and lung function, such as walking briskly on a treadmill or elliptical machine, or pedaling a stationary bike.
fatty acids, such as olive oil. Having adequate levels of vitamin D in our bodies has been shown to promote bone health, muscle function, and general health. Given that the most common source of vitamin D is exposure to sunshine, Minnesotans bundled up against the winter are especially at risk for low vitamin D levels even if they consume vitamin D-enhanced milk and orange juice. For that reason, supplementing your diet with 1,000 units of vitamin D3 daily is recommended. However, check with your health care provider before taking this or any supplement.
Yoga, pilates, and similar strengthening activities help maintain core strength and balance.
For older adults One reason to maintain the overall efficiency of the heart and lungs is that the performance of these organs decreases by 10 percent each decade of adult life. That’s why it’s essential for older adults to maintain an active lifestyle, since engaging in activities that increase the heart rate can significantly curtail this loss. A sedentary lifestyle, even for one season, can eliminate this benefit. Another reason to stay active is to combat sarcopenia, the irreversible loss of muscle cells that happens with age and leads to increased weakness and flabbiness. A successful strategy to reduce the rate of sarcopenia is to use your muscles in sports and/or resistance training all year long, lifelong. Staying active also combats osteoarthritis, the most common type of arthritis. This condition affects weight-bearing joints, especially hips and knees. It commonly involves the spine, hands, and shoulders as well. It is defined as deterioration of the cartilage lining the joints, associated with abnormal calcium deposits within the joints. From an exercise perspective, we know that regular use of our joints prolongs the life of the cartilage. It has been shown that disuse can lead to accelerated deterioration of joint cartilage. Also, weight-bearing activities can improve the amount of healthy bone calcium content and therefore reduce the risk of bone thinning, called osteoporosis or osteopenia. Although running is a weight-bearing activity, many have questioned its potential for causing joint damage. Several recent studies concluded that there is no increased risk for osteoarthritis development in individuals who run regularly for many years. Food matters As humans, we gravitate to comfort foods and increase our caloric intake as the days shorten and the temperature drops. Unfortunately, many comfort foods are high in fat and lead to weight gain. That can increase joint stress, the risk of type 2 diabetes, and the risk of other medical problems. Instead, follow a Mediterranean-type diet that provides a reasonable number of calories. It should contain abundant vegetables and fruits, supply adequate protein, and contain fats rich in omega-3
Bottom line By staying active throughout the winter, you are much more likely to enter spring and summer less likely to injure the ACL and the joints below it. However, exercise of any type and at any level of exertion is better than none. So if access to a gym is a challenge, keep in mind that going for a brisk walk on these winter days provides significant benefit. Maintaining regular exercise year-round, even in the depths of winter, will pay off in a stronger and healthier you in the seasons to come. Jamie Peters, MD, is board-certified in sports medicine and family medicine and practices with Sports and Orthopaedic Specialists in Edina and Plymouth. He is also an adjunct professor in the department of Family Medicine and Community Health at the University of Minnesota.
January/February 2014 Minnesota Health care news
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Drug Cl ass
Bisphosphonates First-line treatment for osteoporosis By Erin Kraemer and Sarah M. Westberg, PharmD, BCPS
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CHOL–2clr 211 530 02.04.14
he body is constantly breaking down and rebuilding bone. When bone degrades faster than it’s rebuilt, osteoporosis occurs and bone becomes brittle and fragile. Individuals usually do not know they have osteoporosis until a fracture occurs, which can be caused by stress as minor as coughing. The most common osteoporosis-caused fractures occur in the hip, spine, and
wrist. The National Osteoporosis Foundation (NOF) estimates 10 million cases of osteoporosis and 33.6 million cases of low bone density occurred in the U.S. in 2012. Risk factors for developing osteoporosis include being female, 65 years of age or older, and/or underweight; having low-density bones; using glucocorticoids long term, such as prednisone for arthritis treatment; using tobacco; and drinking three-plus alcoholic beverages daily. Also at increased risk are those who have had a fractured spine or who have rheumatoid arthritis, untreated medical conditions, or a family history of hip fractures.
Screening The most common screening tool used to assess bone density is a noninvasive X-ray called a DEXA scan, which allows a diagnosis of osteoporosis to be made. NOF guidelines recommend a DEXA scan for women over age 65, men over age 70, those who have had a spinal fracture, and anyone at high risk for osteoporosis.
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Medication One type of medication to prevent and treat osteoporosis is the drug class known as bisphosphonates, which can be taken orally or by infusion. Oral forms include alendronate (Fosamax), ibandronate (Boniva), and risedronate (Actonel). Zoledronic acid (Reclast) and ibandronate (Boniva) are bisphosphonates that are administered through an infusion. According to the Institute for Clinical Systems Improvement (ICSI), bisphosphonates have a better track record of reducing fractures than other anti-osteoporosis treatments. This drug class is considered the first-line treatment for osteoporosis by experts in the field of bone health.
How do they work? Bone is constantly being remodeled by two cell types in the body: osteoclasts (degrade bone) and osteoblasts (build bone). Bisphosphonates interfere with osteoclasts, thereby slowing the breakdown of the bone. This allows the osteoblasts to catch up, leading to increased bone formation. Bisphosphonates can be given as a daily, weekly, or monthly pill, or intravenously. It is important to note that these medications have only been tested in people who consume sufficient calcium and vitamin D. It is recommended that adults consume 1200 mg of calcium and 800 units of vitamin D per
Minnesota Health care news January/February 2014
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day to sustain bone health. The best source of calcium comes from foods like dairy products, fruits, and vegetables. People who do not get adequate calcium from diet alone should take a calcium supplement, most commonly available as calcium carbonate and calcium citrate. Although the latter is the more expensive option it provides more calcium because it is more easily absorbed by the gut. Since the body can only absorb approximately 500 mg of calcium at one time, a 500 mg calcium supplement should be taken twice daily to ensure adequate absorption. In contrast, an entire vitamin D supplement can be consumed once daily. And, since there are few dietary sources of vitamin D, most people must supplement their diet with vitamin D tablets.
This drug class is considered the firstline treatment for osteoporosis.
Administration It is important to take this medication on an empty stomach. The pill should be taken with a full glass of water upon rising in the morning, at least 30 to 60 minutes before any other medication, food, or beverage. It is also important to not lie down for least 30 to 60 minutes after taking the pill to ensure it successfully travels through the esophagus and into the gut. If someone taking the once-weekly product forgets a dose, that dose can be taken the next morning. Never take two doses of this medication at the same time.
Long-term use
Additionally, there are some reported cases of abnormal femur fractures in individuals taking bisphosphonates for extended time periods. It should be acknowledged however, that it is not yet clear if these fractures are bisphosphonate related or osteoporosis related. Further investigation is needed to evaluate the risk of this occurring in the typical person who takes a bisphosphonate for the recommended amount of time.
Reduce osteoporosis risk
Bones naturally lose density with age. Nonetheless, osteoporosis can be prevented or delayed by at least 150 minutes of routine exercise weekly. Include both weight-bearing aerobic exercise, such as walking or jogging, and strength training, such as using resistance bands or lifting light weights. Consume adequate calcium and vitamin D, which the body uses to rebuild bone. Additionally, it is important for those who are currently smoking to stop using tobacco, as that increases the risk of osteoporosis. More information can be found in the National Osteoporosis Foundation Guidelines (www.nof.org).
Erin Kraemer is a PharmD candidate in the University of Minnesota College of Pharmacy, where Sarah M. Westberg, PharmD, BCPS, is an associate professor and provides medication management services at Women’s Health Specialists, University of Minnesota Physicians clinics.
No currently available osteoporosis medications have been studied for lifelong use, nor has the FDA approved any osteoporosis medication for indefinite use. Bisphosphonates are typically given for five to 10 years. Individuals may stop taking them for one to two years after a five-year course of therapy, and then resume taking them. Bisphosphonates are long acting, and continue to work even after someone stops taking them.
Side effects While bisphosphonates are widely prescribed and considered safe in the broad population, common side effects include gastrointestinal discomfort such as abdominal pain, heartburn, nausea, and diarrhea. Individuals may also experience muscle or skeletal aches and pains and should notify their health care providers if these symptoms occur. Rarely, bisphosphonate use can result in osteonecrosis of the jaw (ONJ). In ONJ, sores develop in the mouth that cause parts of the jawbone to become exposed, which occurs in an estimated 1 of every 10,000 patients treated with bisphosphonates. If this happens, the patient stops taking the medication and the ONJ is treated. Bisphosphonates would no longer be used and alternative treatment options for the osteoporosis would need to be considered. The risk of developing ONJ is increased when bisphosphonate is infused instead of taken by mouth. A large majority of the known cases of ONJ occurred in patients who had invasive dental procedures performed while on bisphosphonate therapy. That’s why it’s a good idea to have a dental evaluation, procedures, or treatments performed before beginning bisphosphonate therapy. Ongoing dental care for anyone taking bisphosphonates is encouraged.
Individuals usually do not know they have osteoporosis until a fracture occurs.
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January/February Calendar Jan. 23
Weathering Life’s Losses
Lakeview Hospital offers this grief support group for adults who have experienced the loss of a loved one. Join others who understand to share stories, advice, and support. Free. Call (651) 430-4586 for more information. Thursday, Jan. 23, 6–7:15 p.m., Lakeview Hospital, 927 Churchill St. W., Stillwater
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Mental Health Course for Teens
The National Alliance on Mental Illness hosts this initial session of a free six-week course for teens. Come learn how to maintain good mental health by recognizing signs of stress, anxiety, and depression. Learn how to help loved ones understand what you are going through, as well as different treatment options. To register, contact Andrea at (651) 645-2948 or alee@namimn.org. Tuesday, Jan. 28, 6–8 p.m, Gloria Dei Lutheran Church, 700 S. Snelling Ave., St. Paul
Feb.11
Introduction to Tobacco Cessation
Join this class offered by Allina Health to learn practical strategies to quit smoking. Hear tips on how to beat cravings, relieve stress, deal with tempting social situations, and adjust to life without nicotine. Free. To sign up, call (612) 863-1648. Walk-ins are welcome. Tuesday, Feb. 11, 5–6 p.m., Abbott Northwestern Hospital, Conference Rm. E12, 800 E. 28th St., Minneapolis
13
Living with Late Stage Alzheimer’s
Alzheimer’s Association Minnesota-North Dakota offers this class as part of an educational series for caregivers of people affected by Alzheimer’s disease. Learn what to plan for at each stage, and what you can do to support loved ones along the way. Free. Call (952) 857-0551 for more information. Thursday, Feb. 13, 6:30–7:30 p.m., Christ Presbyterian Church, Fireside Rm., 6901 Normandale Rd., Edina
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February
American Heart 18 Month
According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both men and women in the U.S., causing more than 600,000 deaths each year. Heart disease is an umbrella term for several types of conditions that include diseases of the blood vessels, heart rhythm problems, heart infections, and congenital heart defects. Many people with heart disease face problems related to a process called atherosclerosis, a condition that develops when plaque builds up in the walls of the arteries. The buildup narrows the arteries and makes it difficult for the blood to flow to the heart, which may result in a blood clot that can cause a heart attack or stroke. Though many heart disease risk factors are genetic and out of your control, such as age, gender, and race, there are many that you can control to lower your risk of heart disease. A healthy diet rich in fresh fruits and vegetables, at least 30 minutes of exercise a day, limiting alcohol use, and not smoking can help prevent heart disease. Discuss any concerns you may have regarding your heart health with your doctor, monitor your blood pressure on a regular basis, and check your cholesterol at least once every five years.
Feb.18
Kids in the Kitchen: Heart Healthy Fun
Join your children at this interactive, hands-on cooking class to learn how to prepare and assemble simple recipes with a healthy heart in mind. Designed for elementary-school age children. Free for Twin Cities food co-op members, $5 for non-members. For more information or to sign up, call (952) 891-1212 or visit www.valleynaturalfoods.com. Tuesday, Feb. 18, 6–7:30 p.m., Valley Natural Foods, 13750 County Rd. 11, Burnsville
Minnesota Health care news January/February 2014
Medicare Presentation
Join the Minnesota Board on Aging for this information session to better understand Medicare enrollment guidelines, processes, and benefits. Free. To register, call Marilyn at (651) 431-2500. Tuesday, Feb. 18, 6–7:30 p.m., White Bear Lake Senior Center, 2484 E. County Rd. F, White Bear Lake
19
Advanced Breast Cancer Support Group for Couples
Park Nicollet hosts this free group specifically for couples coping with advanced breast cancer (stage IV or recurrent). Meet others on the same journey and discuss issues related to self-image, positive attitudes, and intimacy. Wednesday, Feb. 19, 6:30–8 p.m., Park Nicollet Frauenshuh Cancer Center, Curtis and Arlene Carlson Family Community Rm., 3931 Louisiana Ave. S., St. Louis Park
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Brain Aneurysm Support Group
HealthEast offers this free support group for those dealing with a brain aneurysm and their significant others, caregivers, or family members. Join others who understand to share stories, advice, and support. No registration required. For more information, call Tess at (651) 326-3415. Thursday, Feb. 27, 12:30–2 p.m., St. Joseph’s Hospital, 45 W. 10th St., St. Paul
March 5
Living Well with a Disability
Minnesota Center for Independent Living hosts this free workshop for people living with a disability. Learn how to incorporate more balance in your life, create meaningful goals, and develop a healthy lifestyle. To sign up, call (651) 603-2030. Please RSVP at least two days in advance. Wednesday, March 5, 5–7 p.m., Metropolitan Center for Independent Living, 530 North Robert St., St. Paul
Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. 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.
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January/February 2014 Minnesota Health care news
SALES PERSON : Omar
Publication: Minnesota Health News
19
Research
Post-traumatic stress disorder New approach may help prevent, as well as treat, this devastating disorder. By William H. Frey II, PhD
P
ost-traumatic stress disorder (PTSD) is a severe anxiety disorder that can develop after an individual is exposed to one or more traumatic events, such as sexual assault, serious injury, or the threat of death. PTSD is characterized by a group of symptoms that may include high levels of anxiety; disturbing, recurring flashbacks; and avoidance or numbing of memories of the event. Symptoms can last a lifetime.
Who is at risk? Approximately 7.7 million American adults and many more millions worldwide have PTSD. But it isn’t just adults who are affected. Children and adolescents exposed to war, physical or sexual assault, abuse, accidents, disasters, or other life-threatening or frightening events are also at
risk for PTSD. Some individuals may experience PTSD after a friend or family member is exposed to danger or is severely harmed. The sudden, unexpected death of a loved one can also precipitate the disorder. Not everyone is equally susceptible to PTSD. Many individuals who are exposed to a traumatic event do not develop this condition. There is some evidence that a susceptibility to it may run in families. Women are more likely to develop PTSD than men because they are more likely to experience high-impact trauma.
Delayed onset increases hope Intrusive memories of the precipitating event, including flashbacks and nightmares, have been reported to contribute more to the biological and psychological dimensions of PTSD than the event itself. These symptoms may not begin until years after the initial trauma. Delayed onset may indicate that there is a significant window of opportunity during which people who have experienced a traumatic event could be treated to prevent the onset of PTSD’s devastating symptoms.
The brain and stress
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Minnesota Health care news January/February 2014
Research in the 1980s showed that glucocorticoids (compounds that the body produces in response to stress) can damage nerve cells in the hippocampus, an area of the brain that is key to both memory and emotional response. One way this damage may occur is by glucocorticoids’ inhibition of glucose uptake and use in the hippocampus. This is critical since glucose is the only source of energy used by brain cells under normal conditions. Cortisol, a major glucocorticoid released in response to stress, has been reported to reduce glucose use in the hippocampus of healthy elderly adults. Glucocorticoids also decrease the capacity of the hippocampus to survive neurological damage by inhibiting glucose transport by up to 30 percent. Nor are these adverse effects on glucose restricted to the hippocampus. Glucocorticoids released in response to major stress inhibit glucose use throughout the brain, as well as inhibiting glucose transport in nerve cells studied in test tubes.
PTSD and glucocorticoids Subsequent research revealed that cortisol concentrations in combat veterans with PTSD were significantly higher than in healthy people. Patients with PTSD related to childhood abuse had cortisol levels that were an average 61 percent higher during the time leading up to a cognitive stress challenge. In addition, the abuse survivors’ cortisol levels were 46 percent higher during the actual cognitive challenge, compared with people without PTSD. Animal models demonstrate that glucocorticoids
induce PTSD-like memory impairments in mice.
Intranasal insulin Insulin facilitates the uptake of glucose into many cells in the body to provide the energy cells need to function properly. When administered as a nasal spray to the roof of the nasal cavity, insulin can travel directly into the brain without having to enter the bloodstream. Certain areas of the brain, including the hippocampus, require insulin to function normally. In order to determine if intranasal insulin could reduce the increase in cortisol in response to stress in normal individuals, the following clinical trial was conducted. German researchers gave intranasal insulin to 26 healthy adult men minutes before they were exposed to the Trier Social Stress Test, a laboratory procedure that reliably produces stress in human research subjects. This significantly diminished the increase in cortisol in the subjects’ saliva and plasma in response to the stress test. Since intranasal insulin attenuates the elevated cortisol response to stress in adult men and generally facilitates the uptake of glucose into cells, it could be helpful as a way to treat and even protect against PTSD. For example, insulin nasal sprays could be used to treat individuals exposed to a traumatic stressful event shortly after it occurred. This treatment could help individuals such as first responders, who are at immediate high risk for traumatic stress, by helping protect their brains against the damaging effects of such stress.
PTSD appear to be more variable. Finally, memory deficits have been reported in patients with PTSD, and short-term memory deficits are characteristic of patients with Alzheimer’s disease. Since intranasal insulin has already been shown to improve shortterm memory in normal healthy adults and in patients in the early stages of Alzheimer’s disease, it would not be surprising if this treatment also ameliorated the short-term memory deficiencies often experienced by patients who have PTSD. Fortunately, it is short-term memory that this treatment improves, since one would not necessarily want to improve long-term memory of traumatic events in patients with PTSD.
Not everyone is equally susceptible to PTSD.
The noninvasive intranasal method for delivering therapeutics (including insulin) directly to the brain to treat brain disorders was first discovered in 1989 and subsequently patented. Intranasal therapeutics rapidly reach the brain by traveling along the nerve pathways involved in smell. This increases the efficacy of the therapeutic in the brain while reducing its exposure to the rest of a person’s body and reducing unwanted side effects. Intranasal insulin has already been shown in multiple phase 2 clinical trials to improve memory in normal healthy adults, in patients who have mild cognitive impairment, and in those who are in the early stage of Alzheimer’s disease. This occurred without changing the blood levels of insulin or glucose.
Features common to PTSD and Alzheimer’s Why should a treatment that improves memory, cognition, and functioning in patients with Alzheimer’s disease also be expected to benefit those with PTSD? Surprisingly, these two disorders have several key things in common. First, both disorders are characterized by elevations in blood levels of cortisol, which has been shown to increase brain pathology in rodent models of Alzheimer’s disease. In humans with Alzheimer’s disease, increased levels of cortisol in the blood are associated with more rapid disease progression. Second, the hippocampus, an area in the brain that is key to memory and emotional response, is damaged by elevated cortisol. This occurs because elevated cortisol inhibits the uptake of glucose that brain cells need for energy. Degeneration of the hippocampus is common in Alzheimer’s disease and has also been reported in patients with PTSD. Third, there is decreased uptake and utilization of glucose in patients with Alzheimer’s disease and in those with PTSD, although results with
Nonetheless, timing of intranasal insulin treatment relative to a traumatic event and development of PTSD needs to be carefully examined. The optimal timing needed to reduce the elevated cortisol response and to improve short-term memory needs to be determined. Clinical trials are now needed to determine if intranasal insulin can benefit individuals with PTSD or those who are at high risk for PTSD. The first such clinical trial is scheduled for 2014. William H. Frey II, PhD, is director of the HealthPartners Alzheimer’s Research Center at Regions Hospital in St. Paul. He invented and patented intranasal delivery of therapeutic proteins to the brain in 1989 and intranasal delivery of insulin to the brain in 1999. Acknowledgment Dr. Frey thanks Drs. Amy Herstein Gervasio and Gihun Yoon for helpful discussions.
Telephone Equipment Distribution (TED) Program
How it works
The future
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 January/February 2014 Minnesota Health care news
21
Policy
Back pain Landing on best treatment By Bret Haake, MD, MBA
B
ack pain affects most people at some point in their lives; one-quarter of U.S. adults have experienced back pain lasting longer than a day during the past three months. In fact, low back pain is the most common type of pain listed by respondents to
a National Institute of Health Statistics survey, and is the fifth-most common reason for all physician visits. And, according to a 2006 review, the total costs associated with low back pain in the United States exceed $100 billion per year, two-thirds of which results from lost wages and reduced productivity. In the beginning When I started practicing neurology in 1994, it wasn’t always clear to me how best to treat patients with back pain. For some patients, surgery was needed. But for the vast majority of patients, the degree of pain and disability they experienced didn’t seem to correlate with the type of injury they had or the degree of change in their spine as seen on MRI or CT scans. During most of those early years I was practicing in Fargo, N.D. In North Dakota at that time, there were few neurologists and even fewer spine surgeons. As a result, I saw a lot of patients with back pain and needed to help them decide if they should see a surgeon or not. The surgeons were just down the hall from me, so, over time, I was able to observe which patients benefited from surgery and which ones did not. Because this was a smaller community, I also was able to note the long-term outcome of patients who didn’t have surgery. Landing on a best approach After a decade of evaluating thousands of patients with back pain and watching how they did with different treatments, it became much clearer to me how physicians should care for patients with back pain. Other physicians were observing the same outcomes, and science was catching up with what we were observing (Annals of Internal Medicine 2007; Institute for Clinical Systems Improvement 2012). What became clear was that: • Back pain is common and a normal part of life. • Back pain doesn’t always imply severe injury. • Most people with back pain get better over time.
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Minnesota Health care news January/February 2014
• It is important to stay active and exercise even if pain is present. • Medications can inhibit healing and can even make pain worse over time. These observations suggested a new strategy for helping patients with back pain. Case in point Many patients through the years have reaffirmed for me that this strategy is correct. One patient in particular illustrates this point strongly. He was a man in his 70s who had been injured in a parachute jump during World War II. Because his parachute didn’t open completely, he broke his legs, pelvis, and several vertebrae in his spine. His back X-ray was among the worst I had ever seen. Yet, he lived a full life as a farmer, raised five children, and had no back pain. When I asked him how he could have no back pain when others had chronic back pain from only minimal injuries, he said, “Yeah, I had pain when I returned from the service. I spent a year in the hospital. But when I got home, I was so happy to be alive that I quit going to doctors, quit my meds, and went on with my life. After a year or two, my pain went away.” This shows how well many patients can do by having a positive attitude, staying active, and avoiding medications. The brain and nervous system are quite adaptive and given time, remodel themselves in a way that most of the time leads to less pain. For many people who have a back injury, the best outcome often comes from positive thinking, exercise, and allowing the body time to repair itself. (To learn which symptoms need immediate attention, see the sidebar on this page.) New approach In 2007, I started working with the spine program at HealthPartners/Regions Hospital. The goals of this program are to help patients with back pain get the care they need when they need it. The first goal is to get people with back pain better faster and with less fear that something bad is wrong. Secondly, our goal is to prevent chronic pain, and lastly, we aim to direct patients to physical therapists and specialists when necessary. When this is done correctly, most patients improve, return to normal activities, and do not need more invasive treatments like injections or surgery. Here are the steps that patients in our program take: 1. First, patients are thoroughly evaluated when they first seek help for back pain. Evaluation occurs wherever the person obtains care: a primary care doctor’s office, specialty care office, chiropractic office, or physical therapy office. As part of their initial evaluation, when appropriate, patients are reassured they do not have a disease, that it is normal to have back pain at times, that it is important to stay active and exercise, and that avoiding medication is often best in the long run. 2. Second, if a patient needs advice on exercise or is not improving quickly, he or she is referred to physical therapy. There, the patient is again reassured that he/she is going to be okay, that exercise is good, and that medication is not the answer.
3. Lastly, for patients Seek help for who continue to back pain if: struggle with back pain despite good • There is a severe injury. intentions, we have • One or both legs become them further evaluaweak. ted by a medical spine • There is loss of bowel or specialist in order to bladder control. assess whether X-rays • There is severe stomach or other consultations pain plus back pain. are needed, but also • There is severe back to reinforce the fact pain plus fever. that they can im• There is unexplained prove with time, that weight loss and significant exercise is important, back pain. and that medications • There is severe back are not the answer. pain that does not start At that juncture we to improve within one to two weeks. also partner with Physicians Neck & Back Clinics to enroll patients in that organization’s active rehabilitation program. This program also focuses on a message of returning to normal activities while putting patients through a rigorous exercise program that has been shown to greatly improve success. Back pain to page 27
It’s always
PERSONAL to us.
Personalized Assisted Living goes a long way toward optimizing the daily quality of life for our residents. If you have a loved one that needs a friendly environment with a personalized care plan designed just for them, call or visit a Brookdale Community near you. Because caring for our residents is what we do, and it’s always personal to us.
To learn more, visit us online at brookdale.com
Alzheimer’s Association is a registered service mark of Alzheimer’s Disease and Related Disorders Association, Inc. ALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc., Nashville, TN, USA. ®Reg. U.S. Patent and TM Office MNM3-RES20-0813 LMM
January/February 2014 Minnesota Health care news
23
insurance
Better together
Dual-eligible programs for Minnesotans on Medicare and Medicaid By Russel J. Kuzel, MD, MMM
D
ual-eligible health care programs combine Medicare and Medicaid health programs and support systems into one package to support the whole person: health care, safety, and social service needs. This holistic approach improves quality of life and extends the member’s ability to live independently in the community.
Read us online Wherever you are!
www.mppub.com 24
Minnesota Health care news January/February 2014
Positive changes Take Bernie, for example. Bernie is deaf and had relied on his mother to help with daily living for quite some time. But Bernie’s mother was moving to an assisted living facility so Bernie relocated to an apartment. Because Bernie is 65 and eligible for both Medicare and Medicaid, he obtained health coverage by enrolling in a dualeligible Medicare/Medicaid program called Minnesota Senior Health Options (MSHO). This program provided Bernie with a care coordinator, Beth, to help him manage his care. When Beth visited Bernie’s new home with a sign language interpreter, she discovered that Bernie needed a primary care doctor in his new neighborhood, in addition to other services. In short order, she scheduled appointments for Bernie with a new primary care doctor and dentist; arranged rides to Bernie’s appointments; obtained a TTY phone and a flashing smoke detector for his apartment; lined up Meals on Wheels deliveries; and connected him with county services and resources specific to his disability. These changes brought about positive outcomes for Bernie and his mom. They are both thriving in their new homes, and Bernie has the help he needs to continue living independently. History Minnesota has a reputation for health care innovation. State legislators, leaders at the state’s Department of Human Services and the Minnesota Department of Health, and health plan executives have long collaborated to develop new, different, and better health care programs. In the 1990s, they discussed improvements to the way the state served enrollees in Medicare and Medicaid (or Medical Assistance in Minnesota) programs. Their collective ideas spawned a groundbreaking new program that combined and simplified member benefits, and streamlined financing to save health care costs. In 1995, Minnesota became the first state to obtain approval from the federal Centers for Medicare & Medicaid Services (CMS) for a pilot program, called a demonstration program, to fully integrate Medicare and Medicaid contracts with health plans and to
combine Medicare and Medicaid financing and services for dual-eligible seniors living in the Twin Cities area. In 2001, people with disabilities were added to the program. Then, with the rollout of Medicare’s Part D prescription drug coverage in 2005, this program became recognized as Medicare Advantage Dual-Eligible Special Needs Plans by the federal government. Eligibility Two different types of health care programs integrate Medicare and Medicaid coverage for dual-eligible residents statewide. They are: 1) Minnesota Senior Health Options (MSHO) for people 65 years and older and 2) Special Needs BasicCare (SNBC) for adults age 18–64 with a certified disability. Not all SNBC plans offer dual coverage; some plans only serve Medicaid (Medical Assistance) beneficiaries. According to October 2013 data from the Minnesota Department of Human Services, about 37,000 Minnesotans are enrolled in dual-eligible health care programs. Dual-eligible programs are co-administered by the Minnesota Department of Human Services and the state’s managed care plans.
benefits, disease management programs, falls-prevention assistance, enhanced dental care, and rewards for preventive care such as cancer screenings. Care coordinators As Bernie’s story illustrates, care coordinators make a real difference in a member’s life. Care coordinators, who are nurses or social workers, help dual-eligible members get answers to health care and medication questions, get needed care, and facilitate information-sharing among doctors and other providers across the health care continuum. The care coordinator ensures that primary care doctors, specialists, physical therapists, home care, and hospital staff are in contact with each other and are aware of the health status of the member, especially during transitions from hospital to home or rehab facility. Each member’s care coordinator visits the member’s home initially to assess the safety of his or her surroundings and the need for assistance with daily living. The care coordinator visits at least annually thereafter, although members with complex medical conditions such as diabetes or heart disease may also receive nurse visits on a regular basis to help them manage their conditions and medications, and to keep their health in check. The care coordinator also can arrange a home health aide to assist with hygiene and personal care, and also can schedule home-
About 37,000 Minnesotans are enrolled in dual-eligible health care programs.
Advantages Dual-eligible programs help to keep members out of the hospital and living safely at home, which helps control health care costs. This integrated program benefits doctors and the entire health system, too, by consolidating claims for services, thus reducing paperwork. Combining Medicare and Medicaid benefits means that members complete one enrollment form as opposed to two. Instead of using different ID cards to receive health care services, one card does it all. Members also don’t need to visit different offices for different needs or to fill out reams of paperwork. They receive one set of health care materials, while their health plan connects them to needed health care, to home- and community-based services, and handles most of the paperwork for Medicare and Medicaid. The rest of the paperwork is handled by the member or that person’s family, his or her care coordinator, or the member’s county social worker. Benefits Members receive a full array of health care coverage ranging from doctor visits, hospitalization, dental care, labs and X-rays, and durable medical equipment to prescription drugs, personal care attendants, home health services, nursing home care, transportation, and interpreter services. In addition, members receive assistance from a care coordinator/care navigator who ensures they receive the services they need. Some health plan programs also include fitness
Resources • MN Department of Human Services: www.mn.gov/dhs • Senior LinkAge Line: www.mnaging.org, (800) 333-2433
Beter together to page 26
A diagnosis of
Cancer
is overwhelming news.
It raises many questions few of us are prepared to answer, such as: • How can I take time off from work? • Can I get help paying bills? • What is the difference between a health care directive and a power of attorney? • Can I keep my health insurance even if I lose my job? • And many others. If you or a loved one is facing cancer, we are here to help.
We are a nonprofit organization funded entirely through grants and donations. Your tax-deductible donations are welcome.
We provide free cancer related legal information on a wide range of topics.
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• Disability Linkage Line: www.minnesotahelp.info, (866) 333-2466 • Disability Benefits 101: www.mn.db101.org • Minnesota Help: www.minnesotahelp.info • Medicare: www.medicare.gov
educate.inform.empower January/February 2014 Minnesota Health care news
25
Better together from page 25
making, chore services, and adult day care. How to enroll To enroll in these programs, an individual must be eligible for Medicaid (Medical Assistance) and already enrolled in Medicare. Eligibility is determined by the member’s health plan, which screens the member by age, service area, and Medicare eligibility. If the prospect passes that screening, then the health plan submits a completed enrollment form to the Department of Human Services, which screens for Medicaid eligibility. Enrollment is voluntary and free; there are no monthly premiums, and members can dis-enroll or switch health plan providers at any time. Eight health plans offer MSHO programs; three plans offer dual SNBC (disability) coverage. To find out which plans offer MSHO and/or SNBC, individuals should contact the health plans in their county. To learn how to contact health plans for more information, and to learn in which counties dual-eligible coverage is offered, visit the Minnesota Department of Human Services website (www.mn.gov/ dhs). People can also contact their county human services agency for help finding a dual-eligible program in their area. Enrollment in these programs is not accessible through the state’s online marketplace, MNsure.
Results Since these combined health care programs emerged in the mid1990s, the state has seen remarkable results, including: • H igh satisfaction ratings from members and higher than expected enrollment • Fewer people moving to nursing homes • Improved access to community services for underserved populations • Development and growth of geriatric care systems • A single point of accountability for evaluating health outcomes MSHO members experience less hospitalization, fewer emergency room and physician visits, and have fewer prescriptions than comparable people who are not MSHO members.
Dual-eligible programs help to keep members out of the hospital and living safely at home
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Minnesota Health care news January/February 2014
Continuing improvement Combining Medicare and Medicaid coverage in dual-eligible health care programs is administratively challenging due to the complexities of these different state and federal programs. Accordingly, the federal government is working with states to address some of these challenges. Dual-eligible programs continue to evolve as they improve their integration of the best of Medicare and Medicaid. Russel J. Kuzel, MD, MMM, is senior vice president and chief medical officer for UCare, a nonprofit, independent health plan serving more than 300,000 members in Minnesota and western Wisconsin.
Back pain from page 23
Results Since our program began, there has been a decrease in the number of patients needing medications for back pain; a decrease in the number of patients needing procedures; and a decrease in the number of patients needing the more aggressive active rehabilitation program. We believe this means that patients are getting better earlier and that fewer people are having persistently troublesome back pain. In addition to these advantages of rethinking how to treat back pain, this approach reduces overall health expenditures. In fact, in one year, approximately $2 million in cost savings were realized through less use of medication and imaging, fewer visits to the emergency room, and fewer hospitalizations.
Decrease your risk for back pain 1. Keep active and exercise regularly. 2. Keep your weight in check. 3. Do not smoke. Smoking has been shown to decrease blood flow to the structures in the back, predisposing to back pain and inhibiting healing after back injury. 4. Be aware of your posture. Keep your back straight and lift with your legs. 5. Try to keep depression and anxiety in check, as this correlates with more back pain.
Getting better Care of patients with back pain is no longer a mystery. At first, due to lack of a clear treatment path, patients were told to be careful, were told that they had a degenerative condition, and were told to take medication. This benign-sounding advice inadvertently led to more chronic back pain and interventions down the road. Now we know that with appropriate evaluation, reassurance that pain is normal and that it gets better with time, an emphasis on activity and exercise, and minimizing medication, the vast majority of patients get better sooner and with less residual disability.
Back pain is common and a normal part of life.
Acknowledgment The treatment model described here would not have been possible without the invaluable contributions of Denis P. McCarren, MS, PT, MBA, original Regions spine project manager and now director of neurosciences at HealthPartners and Regions; medical spine specialist, Michael Goertz, MD; the great team of spine specialists at Physicians Neck and Back Clinics; and the thoughtful and talented surgeons at HealthPartners Medical Group and Regions. Bret Haake, MD, MBA, is the assistant medical director of neurosciences and the head of neurology at HealthPartners and Regions Hospital, St. Paul. He is also an associate professor of neurology at the University of Minnesota.
Chemical dependency in older adults is hard to recognize We help them live a healthier life Alcohol and drug abuse by seniors often goes unnoticed because of isolation and loneliness. As a result, the older adult continues to suffer in silence. Senior Helping Hands is a program of St. Cloud Hospital Recovery Plus and a recognized national leader providing support and services to stop the suffering. Senior Helping Hands serves individuals age 55 and older. Services • Outreach service and consultation with family or concerned persons • Evaluation and assessment for chemical dependency and/or mental health issues completed by qualified professionals • Volunteer support for older adults who are chemically dependent • Support from peer volunteer counselors for older adults with mental health issues Programs Older Adult Chemical Dependency Primary Treatment Program A comprehensive program that involves physical/psychosocial/chemical use assessments performed by professionals trained in chemical dependency and mental health, including a full time Medical Director who is an addictionist. The program provides a slow pace, holistic approach to recovery. Transportation and temporary housing are available if needed.
Contact Us 713 Anderson Ave., St. Cloud, MN 56303 (320) 229-3762 • (800) 742-HELP toll-free www.centracare.com (Search: Senior Helping Hands)
January/February 2014 Minnesota Health care news
27
H e a lt h P r o f e s s i o n s
Adolescent medicine Helping youth and families through challenging times By Naomi Duke, MD, MPH, FAAP
A
dolescent medicine cares for youth between pediatrics and adult medicine, and helps parents understand behaviors that characterize normal development. Specialists in this field
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support a family when a young person is struggling and the family doesn’t know how to respond. We partner with teachers and school administrators to create educational opportunities that promote healthy physical and socioemotional development, and communicate with local and state policymakers to make sure youth’s concerns and priorities are visible. How it began The importance of student health began being recognized in Europe and in this country during the late 1800s–early 1900s. In mid-20th century United States, J. Roswell Gallagher, MD, argued that adolescent health care needs are distinct from those of adults and children. He proposed that adolescents should be seen by physicians separately from their parents and viewed as responsible for their own health. Training for adolescent medicine specialists includes internship and residency training in a specialty category, such as pediatrics, family medicine, internal medicine, or a combination of internal medicine and pediatrics. This is followed by a fellowship in adolescent medicine that combines specialized clinical training with the development of research and advocacy skills.
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Minnesota Health care news January/February 2014
Age-specific interaction Visits between the adolescent and the physician are tailored to the youth’s developmental stage. Someone age 10–13 is most likely to respond to messages about health and risk behaviors that focus on short-term cause and effect. Middle adolescents (ages 14–17) are better at taking into account other viewpoints in decision-making. Older adolescents and young adults (ages 18–25) more readily understand long-term consequences of behavior. When working with youth, one approach we use questions them about their strengths before proceeding to review environmental context and risk potential. This approach is called SSHADESS: Strengths or interests, School, Home, Activities, Drugs/substance
use, Emotions/depression, Sexuality, and Safety. One method to facilitate behavior change is motivational interviewing. This is a counseling technique in which the health provider partners with the adolescent to elicit the youth’s values and goals, establish the youth’s readiness for change, and affirm the youth’s responsibility for determining if, how, and when change will occur.
the brain that control impulses and oversee some aspects of decision-making. Adolescents are continually trying to understand who they are in relationship to family, peers, and societal roles. This applies to youth’s gender identity as well as to other aspects of self.
Adolescents are not yet fully capable of controlling impulses that may arise in emotionally charged situations.
Our approach to outpatient mental health therapy includes stress management, development of social skills, and development of lifelong coping strategies. For eating disorders, a team approach includes nutrition, social work, medicine, and psychology or psychiatry.
Emerging trends Compared with 2007, data from the Minnesota Student Survey reveal that among students in grades 6, 9, and 12, more youth plan to go to college, feel respected by their teachers, report a high sense of safety in school, and use seat belts. Physical activity and fruit consumption are increasing among 9th and 12th graders. Tobacco and alcohol use are declining although there still is room for improvement, especially in the area of binge drinking. About three in 10 Minnesota seniors report using marijuana during the previous year, close to the highest levels reported since the late 1990s. According to Teenwise Minnesota, rates of pregnancy and birth among females ages 15–19 are declining, despite community-specific disparities. More 9th and 12th graders report having had sex at least once in their life, but rates of sex among Minnesota youth remain lower than national estimates. Condom use increased during the last decade but has decreased during the last three years. The Minnesota Department of Health reports that African American, Native American, and Hispanic youth generally experience negative health much more often than their Caucasian peers. Youth of color are two to five times more likely to experience poverty and to fail to graduate from high school. The adolescent brain In contrast to the adult brain, the adolescent brain is under construction. Brain imaging studies suggest that the brain continues to develop throughout adolescence and into a person’s early to mid-20s. During adolescence and young adulthood, the brain increases its capacity for executive functioning, which includes attention, regulation of emotions, organization, and planning. We are beginning to understand that, in many cases, adolescents have similar academic capabilities as adults. This means that they are able to make informed choices, as in the case of choosing a birth control option.
During this time, youth may become disillusioned when their understanding of who they are is challenged and sometimes negated by family, friends, and even health providers who seek to impose their values.
Confidentiality Adolescent medicine providers are responsible for knowing federal, state, and local laws and regulations concerning consent and confidentiality for minors. One-on-one conversations between a provider and youth are built upon privacy. However, confidentiality must be broken when a young person gives any information suggesting they are considering hurting self or someone else, or that they are being abused or neglected by an adult. Adolescent medicine to page 34
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But, unlike most adults, adolescents are not yet fully capable of controlling impulses that may arise in emotionally charged situations where a decision is needed in the heat of the moment. During adolescence, the parts of the brain responsible for expressing emotions and seeking gratification tend to mature before regions of January/February 2014 Minnesota Health care news
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phar m acy
Buying medicine online Buyer beware By David Hoang, PharmD, Jason Varin, PharmD, and Craig Else, PharmD
T
he Internet makes it easy to shop and have purchases delivered conveniently to our doorstep. Unfortunately, buying online also makes it easy for illegal or questionable “businesses” to operate. Among the most dangerous of these operations are illegal pharmacies. Although some pharmacy websites are
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Minnesota Health care news January/February 2014
reputable, the vast majority of them operate illegally and without regulation. Such illicit operations often provide counterfeit and even highly addictive prescription drugs. Just ask the family and friends of Justin Pearson, a young man from St. Cloud. Justin died at age 24 as a result of a potent mix of prescription drugs he purchased—without valid prescriptions— from rogue websites. A big problem As a result of Justin and others who have fallen victim to a similar fate, the Food and Drug Administration (FDA) cracked down on illegal online pharmacies. In a July 2013 interview with CNN, the FDA stated that it had shut down more than 1,600 websites for selling counterfeit or inferior quality medicines, or for selling medicines without appropriate safeguards. The FDA also issued regulatory warnings to many more websites that were questionable. The National Association of Boards of Pharmacy (NABP) continually reviews Internet sites that sell prescription drugs; more than 10,500 sites have been reviewed to date. Of these, a staggering 97 percent were not complying with pharmacy laws and practice standards and have fallen into the “Not Recommended” category. Of the 10,181 Internet drug outlets listed as Not Recommended on the NABP website (www.nabp.net/boards-of-pharmacy): • 88 percent do not require a valid prescription. • 60 percent issue prescriptions after an online consultation or questionnaire. • 49 percent offer foreign drugs or those that are otherwise non-FDA approved. • 41 percent have Internet server locations outside the U.S. (and thus outside FDA jurisdiction). • 16 percent do not have secure websites. • 12 percent dispense controlled substances.
According to Cody Wiberg, PharmD, MS, RPh, executive director of the Minnesota Board of Pharmacy, legitimate pharmacy websites are licensed by the state in which they are physically located and also by the states to which they ship prescriptions. In addition, legitimate online pharmacies require someone who wants to purchase medicine to submit a valid prescription, issued by a health care practitioner who is licensed to prescribe. Legitimate pharmacies are inspected to make sure they’re in compliance with the laws and rules of the state they are located in, just as brick-and-mortar pharmacies are inspected.
Location, license, contact information available. A legitimate website is
licensed by the Board of Pharmacy of the state in which it operates. A list of state Boards is available at the website of the National Association of Boards of Pharmacy (NABP) (www.nabp.net/ boards-of-pharmacy).
Legitimate online pharmacies must have a legitimate street address.
One way to avoid the risk of using rogue sites is to fill all your prescriptions and obtain all supplements you may use from the same pharmacy in your local community. In addition to being assured you’re receiving prescription drugs that are FDA approved, you may benefit from face-to-face interaction with your local state-licensed and registered pharmacist. Many studies have shown that this interaction helps people obtain maximum benefit from prescription medication. However, if you decide to use an online pharmacy, please use the following guidelines to distinguish between trustworthy sites and fraudulent ones. Unsafe websites No prescription required. Websites that sell prescription drugs with-
out a valid prescription from a licensed provider are illegal and dangerous.
Access to a licensed pharmacist. A trustworthy website will have a licensed pharmacist available to answer questions about medicines. Verified Internet Pharmacy Practice Sites Seal. Visit the VIPPS website
to find a list of legitimate online pharmacies that have earned the VIPPS seal (www.nabp.net/programs/accreditation/vipps). If you see an online pharmacy listed on this site, it means that the site meets state licensure requirements as well as other NABP criteria. More tip-offs Deceitful websites may display fake VIPPS seals. In addition, their names Buying medicine online to page 32
In the next issue...
Location unknown. Legitimate online pharmacies must have a
legitimate street address in order to be registered with a state Board of Pharmacy, which is necessary in order to dispense FDA-approved drugs. (Prescription drugs are regulated by the FDA; dispensing prescription drugs is regulated by state Boards of Pharmacy.) Rogue pharmacies often do not have a legitimate address. Contact information unknown. Rogue websites don’t want you to
be able to contact them, other than to take your order and collect your payment. Their primary purpose is to turn a profit without regard to consumers’ health and safety. They usually have no interest in answering questions unless it improves the chances of separating you from your money. Lowest prices. Beware of “lowest price” claims. “If it seems too
good to be true, chances are it is too good to be true,” applies here. Trustworthy websites Prescription required. Any trustworthy pharmacy will insist that a customer provide a valid prescription from a licensed health care provider. A legitimate pharmacy is obligated by law to ensure that medicines dispensed to you are for reasonable medical purposes. Additionally, a legitimate pharmacy should work with you and your prescribing provider to maximize the effectiveness of your medicines and to monitor for any unwanted side effects.
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January/February 2014 Minnesota Health care news
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maximize their effectiveness, and will monitor for any problematic or potentially dangerous interactions. This is especially important when you are taking medications prescribed by more than one provider. That’s because one provider may unknowingly prescribe a medicine that duplicates medicine prescribed by another provider—inadvertently risking an overdose—or can interact adversely with medicine prescribed by a different provider. Either situation can result in poor health outcomes, and is much less likely to occur if you obtain all medicines and supplements from the same local pharmacy.
Buying medicine online from page 31
may resemble those of legitimate pharmacies. For example, Walgreens-Store.com, an illegal site that was shut down by the FDA, easily could have been confused with the well-known drugstore chain’s website, Walgreens.com. How to protect yourself • Only order medicines online from a trustworthy source, using the tips above.
A legitimate website is licensed by the Board of Pharmacy of the state in which it operates.
• Review and understand websites’ privacy and security policies. • Check with your state Board of Pharmacy or NABP to learn if an online pharmacy has a valid pharmacy license. • If medicine you are taking strains your finances, don’t automatically resort to an online website that advertises cheaper pricing. Ask your local pharmacist for an alternative. Chances are that your pharmacist will call your physician to suggest a change to a less expensive medication if a suitable alternative medicine is available. • Find a local pharmacy you trust. Its pharmacist will help you keep track of all your medicines and how to take them to
Know the risks We all want to save money whenever possible, but please don’t trade your health—and life—for a few bucks. Knowing the risks of purchasing medicine online can help you make wise decisions that protect yourself and your family from the dangers posed by rogue websites. David Hoang, PharmD, Jason Varin, PharmD, and Craig Else, PharmD, are members of the Minnesota Pharmacists Association. Permission to publish the VIPPS® logo granted by the National Association of Boards of Pharmacy®.
Minnesota
Health Care Consumer December survey results ... Association
Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited. For more information, please visit www.mnhcca.org. We are pleased to present the results of the December survey.
40 30 20 10 0
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No opinion
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Percentage of total responses
4. T he decreased hours of sunlight in winter have a noticeable effect on my mood/mental health. 40
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35 30 25 20 15 10 5 0
Strongly agree
Agree
No opinion
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50 40 30 20 10 0
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No opinion
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5. In the winter I notice a decline in personal physical activity. 60
50 40 30 20 10 0
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Minnesota Health care news January/February 2014
No opinion
Disagree
Strongly disagree
3. My diet changes substantively in the winter from what it is in the summer. 50
Percentage of total responses
Percentage of total responses
50
2. I approach maintaining my health differently in the winter than the summer. 60
Percentage of total responses
Percentage of total responses
1. I am more prone to illness in the winter than the summer.
40 30 20 10 0
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No opinion
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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.
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â&#x20AC;&#x153;A way for you to make a differenceâ&#x20AC;? January/February 2014 Minnesota Health care news SEPTEMBER 2013 MINNESOTA HEALTH CARE NEWS
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Adolescent medicine from page 29
In situations where there are clearly damaging behaviors occurring and there is concern for a young person’s safety (such as driving under the influence), adolescent medicine specialists have to make clear to the adolescent their concerns for the adolescent’s safety and must work with the youth to identify immediate sources of help.
Adolescent behavior and future health Risk behaviors resulting in accidents may have catastrophic effect. Disease processes that begin in adolescence often become apparent only decades later. Poor dietary habits and limited physical activity may set up a youth for chronic medical conditions that include overweight, obesity, and associated diagnoses of high blood pressure, diabetes, and elevated cholesterol. Chronic conditions, including addiction, infertility, and HIV infection, and sometimes loss of life, are largely the result of risk behaviors and poor choices that co-occur: tobacco, alcohol, and other drug use; unhealthy dietary intake and inadequate physical activity; and unsafe sexual activity.
Disease processes that begin in adolescence often become apparent only decades later.
A youth’s concerns about confidentiality usually occur in the context of sexual health care. Minnesota minors may access reproductive health services, including pregnancy testing, contraceptive counseling and prescription, and care related to the prevention and treatment of sexually transmitted infection, without parental consent.
The future of the specialty Right now, adolescent medicine specialists have good standing (or at least a presence) in most academic medical centers. An increasing number of group practices recognize the value of including an adolescent medicine specialist. We have some work to do to establish our expertise and value in the eyes of insurance companies.
Naomi Duke, MD, MPH, FAAP, is board-certified in internal medicine, pediatrics, and adolescent medicine. She is medical director of myHealth (formerly West Suburban Teen Clinic), Hopkins, and is an assistant professor in the Department of Pediatrics at the University of Minnesota.
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We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health. Whether you have experienced any type of cardiac event, are at risk for one, or
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Minnesota Health care news January/February 2014
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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].
VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1
for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%). Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Add-on to Metformin Victoza® + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) None Insulin detemir + Continued Victoza® Add-on to Victoza® + Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — Add-on to Glimepiride Victoza® + Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study. In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator. After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown. Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013
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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8
mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial ®+ 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