Volume XXVll, No. 3
The Independent Medical Business Newspaper
Genetic research and cystic fibrosis Targeted drug development leads to improved treatment By Warren Regelmann, MD
It’s not easy being green
our waste invades landfills; hese days, we hear a lot Why should tion; our dependence on disposable about “greening,” as supplies is staggering. The irony health care communities, businesses, is, health care professionals recschools, and government organicare? ognize the essential truth that zations are swept up into an environmental health emerging eco-revolution. As a By Crystal Saric and patient health are society, we are realizing that if Fashant, MPNA interconnected. We we begin reducing our waste, understand that when lessening our energy consumpwe promote healthy environtion, and valuing product stewardship, we ments—what we breathe, what can enjoy an improved natural environwe eat, what we expose our bodment. But what does “green” have to do ies to—we will promote healthy with health care specifically? Read on. communities. And healthy comThe truth is that health care, as an munities are what we “do” in industry, takes an enormous toll on the health care. environment. Our energy creates air pollu-
n January 2012, treatment of inherited diseases took a giant leap forward when the Food and Drug Administration approved Kalydeco (ivacaftor), a drug that improves the lives of people with cystic fibrosis (CF) by restoring function to one variant of the protein that causes CF. CF affects about 30,000 children and adults in the United States and is the most common inherited life-limiting disease among Caucasians, but it occurs in most other races as well. Ivacaftor will very likely improve and prolong the lives of patients who have a rare mutation in their cystic fibrosis transmembrane conductance regulator (CFTR). For them, this drug represents a major SPECIAL FOCUS: advance. However, this new drug is exciting MEDICAL not only because it FACILITY offers CF patients an DESIGN improved quality of life Page 22 but also because it
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JUNE 2013 Volume XXVII, No. 3
FEATURES It’s not easy being green Why should health care care?
MINNESOTA HEALTH CARE ROUNDTABLE
By Crystal Saric Fashant, MPNA
Genetic research and cystic fibrosis Targeted drug development leads to improved treatment
By Warren Regelmann, MD
Health care architecture honor roll
MEDICINE AND THE LAW HIPAA update 16
By Timothy Johnson, JD, and Jesse Berg, JD, MPH
8 PROFESSIONAL UPDATE: NEPHROLOGY Chronic kidney disease 18
Beverly Yashar, MS, PhD
By Nathan T. Blake, PharmD, and Wendy L. St. Peter, PharmD
American Board of Genetic Counseling
Advanced care planning Addressing end-of-life issues Thursday, October 24, 2013 1:00 – 4:00 PM • Symphony Ballroom Downtown Mpls. Hilton and Towers
SPECIAL FOCUS: MEDICAL FACILITY DESIGN Freestanding “urgency Moving? Growing? room” facilities 20 By Nancy Doyle, AIA, By Gary Gosewisch, MD
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The doctor’s advocate By Louis Suarez, CCIM
Building a chorus of voices
By Don Thomas, CD, and Scott Holmes, AIA, ACHA, LEED AP
Background and focus: For the majority, end-of-life is the most medically managed part of life. With it come complex issues that involve economics, ethics, politics, medical science, resources and more. Advances in technology are extending life expectancies and require a redefinition of the term “end-of-life.” It now entails a longer time frame than one’s final weeks or hours and debate as to when life is really over. Mechanisms exist to facilitate personal direction around this topic, but there is a need for improved coordination among the entities that provide end-of-life support.
Objectives: We will discuss the significant infrastructure that supports end-of-life care. We will examine the roles of long-term care/assisted living, palliative care, gerontology, and hospice. We will review the elements that go into creating advanced directives, societal issues that make having them necessary, and the difficulties encountered in bringing them to their current state. We will present a potential road map to optimal utilization of end-of-life support today and how it may best be improved in the future. Panelists include: Ed Ratner, MD, University of Minnesota Center for BioEthics
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JUNE 2013 MINNESOTA PHYSICIAN
HHS Releases Data On Hospital Charges The news that hospitals have widely varying costs for procedures may not be a shock to many in the health care industry, but a move by the federal government to publicize that range of costs recently generated headlines across the nation. On May 8, the U.S. Department of Health and Human Services (HHS) released cost data from hospitals across the country for the 100 most common Medicare inpatient stays. HHS Secretary Kathleen Sebelius says the data will help make the nation’s health care system more affordable and accountable. “Currently, consumers don’t know what a hospital is charging them or their insurance company for a given procedure, like a knee replacement, or how much of a price difference there is at different hospitals, even within the same city,” Secretary Sebelius said. “This data and new data centers will help fill that gap.”
The data show dramatic variation in what hospitals charge for services. From the Medicare data, charges for major lower joint replacement could range from $21,000 to $88,000, depending on the hospital. In Minnesota, charges also varied significantly. At the University of Minnesota Medical Center, Fairview, a major cardiovascular procedure would cost $65,886, according to HHS data. Less than a mile away, at Abbott Northwestern Hospital, a similar procedure would cost $88,877. Health care experts say hospitals factor in a wide range of expenses when pricing any one procedure, and that prices can be different from the listed Medicare charges due to discounts negotiated with health plans. One analysis of the HHS data shows that Minnesota hospitals have lower costs for many major procedures than the national average. The analysis, published in the Washington Post, looked at 10 common medical procedures for Medicare
patients and found that Minnesota’s average cost was lower than the national average in every instance.
Dayton Announces MNsure Board Gov. Mark Dayton has appointed seven Minnesotans to oversee MNsure, the state’s health insurance exchange. State officials say the board members were chosen from 112 candidates. Members will serve four-year terms, and with the exception of the DHS commissioner, are limited to two terms of service. “The individuals chosen to serve on this board represent a broad diversity of experience and expertise,” says Gov. Dayton. “Their collective breadth of knowledge, and each board member’s shared commitment to the successful development and delivery of this new health care marketplace, will serve the best interests of all Minnesotans.” Board members include: Thompson Aderinkomi, founder and CEO, RetraceHealth, a
health-data analytics firm; Pete Benner, a consultant on health care, labor relations, and public policy; Brian Beutner, CEO of mPay Gateway, a health-care software company, and a former general counsel of UnitedHealthcare; Kathryn Duevel, a retired ob-gyn physician from Willmar; Tom Forsythe, vice president of global communications at General Mills; Lucinda Jesson, Commissioner of the Minnesota Department of Human Services; and Phil Norrgard, director of human services, Fond du Lac Reservation.
Blue Cross Delays New Payment System Blue Cross and Blue Shield of Minnesota has agreed to delay implementation of a new payment system for rural hospitals. The new system, which Blue Cross had been rolling out in different parts of the state this spring, caused the Minnesota Hospital Association (MHA) to publicly call for the Bloomington-based insurer to slow down implementation of the change.
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MHA officials said rural hospitals had complained they could not comply with the changes in time, and some were at risk to lose their contracts with Blue Cross. The issue raised enough outcry that Minnesota Attorney General Lori Swanson and Minnesota Health Commissioner Ed Ehlinger, MD, met with Blue Cross officials to discuss the matter. State officials seemed particularly concerned about how the new system would affect critical access hospitals, which are small, rural hospitals that serve outstate areas. After discussion with state officials, Blue Cross announced it was delaying the changes. Blue Cross released a statement on May 1, saying that it was moving the implementation date for the new payment system to Jan. 1, 2014. The statement added that Blue Cross values critical access hospitals and that it would work with them to implement the new system, including sharing costs of software needed for new reimbursement models. On May 1, MHA officials welcomed the announcement that Blue Cross had moved back the implementation date, saying the hospital association agrees that payment models need to change. “A delay provides a window of opportunity for Blue Cross and hospitals to work through the issues before attempting to implement payment changes that could have jeopardized access to care in some communities,” the statement said. “MHA appreciates that Blue Cross has heard the concerns of our members and that it is willing to respond to those concerns.”
MMA Considers Changes to Governance Structure The Minnesota Medical Association (MMA) is considering changes to its governance structure. On May 4, the MMA board of trustees voted to submit a resolution to the group’s House of Delegates at its annual
meeting in September that would replace the House of Delegates with a policy council. MMA officials say if passed, the changes would mean the group’s annual meetings would continue but policy would be determined by the council, which would meet at least twice a year. The policy council membership would be appointed by medical societies that are part of the MMA, and the council would gather member input throughout the year at listening sessions and policy forums. The board of trustees is also in the process of downsizing itself. Working from recommendations of an MMA leadership committee, the board will be reduced by five positions this year. At the MMA’s annual meeting in 2012, the house of delegates voted to reduce the board’s size from 32 trustees to 12–14 members over a three-year period. The reduction of five positions would be the first step in that process. MMA leaders say a 32-member board has proven to be unwieldy and inefficient. According to David Thorson, MD, chair of the MMA’s board of trustees, the House of Delegates has seen a decline in participation and there are concerns that it does not represent a true cross-section of Minnesota physicians. “We’ve noticed a dwindling attendance and it was not tending to bring in new people,” Thorson says. “It was not a very diverse population, ethnically, racially, or age-wise.” The physicians’ association has already held some preliminary policy forums, and Thorson says the results are encouraging. He notes that at the three forums held so far, more than half of physician participants had never attended an MMA House of Delegates meeting. “We’re getting people involved who have never been involved before,” Thorson says. “That’s exciting to me, to see newer people, younger people coming in.”
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U of M, Fairview Plan Management Systems Integration The University of Minnesota and Fairview Health Services have agreed to a new management structure and increased funding for U of M health services, education, and research. The announcement, which was approved by the U of M board of regents on May 10, came approximately one month after Fairview and the university publicly revealed merger talks with South Dakota-based Sanford Health. However, that proposal quickly fell apart, and officials with the University and Fairview noted that the two organizations have been negotiating this deal for some time. Under the agreement, Fairview will provide $90 million to the U of M over the next 10 years, which the university will invest in academic medical services, research, and education. If certain performance goals are met, the amount of
funding Fairview provides the university could increase. The new agreement is not a merger or acquisition, officials with the two organizations say, but rather, an integration of management systems that will allow Fairview and the U of M to coordinate patient care and plan for future changes in health care education and delivery. Officials say that Fairview and the University will now have a joint management structure, with a new board over the integrated system, which will replace boards at the university’s medical center and at U of M’s Amplatz Children’s Hospital. “We envision this as a way of breaking down silos that exist between the organizations,” says Bobbi Daniels, CEO of University of Minnesota Physicians (UMPhysicians). “Integration of inpatient and outpatient services is a national trend. Because so many of our patients are so complex, that coordination is even more critical.” Daniels and Carolyn Wilson, president of the University of Minnesota Medical Center,
Fairview, will lead the new, integrated system. They will oversee a system that has 700,000 patient clinic visits and 35,000 hospital admissions each year. The combined organizations employ 7,500 staff and 800 physicians with UMPhysicians. The integrated structure will bring in an estimated $1.9 billion in revenues annually.
CMS Announces Funds for Medical Assistance Expansion The Centers for Medicare & Medicaid Services (CMS) has told Minnesota officials that the state could get an additional $13 to $14 million annually as part of expanding public health insurance programs under the Affordable Care Act. Officials with the Minnesota Department of Human Services (DHS) say CMS has announced that the federal match for services associated with new Medical Assistance enrollment will increase from 50 percent to 75 percent.
The enhanced match will be available starting in October 2013. DHS recently sent out materials to county human services directors in Minnesota to inform them how the increased funding will affect counties. The funding will help counties handle the increased number of public program enrollees, funding services such as intake, determination of eligibility, case maintenance, computer support, and customer service. “Thanks to the Affordable Care Act, more than 200,000 more Minnesotans will receive health care through our public programs,” says DHS Commissioner Lucinda Jesson. “Counties will be an important partner in helping those Minnesotans get coverage. We would like to thank the U.S. Health and Human Services Department for providing the counties with the resources they need to make health care available to more people.”
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MEDICUS Patrick J. Flynn, MD, received the David King Community Clinical Scientist Award at the 39th national meeting of the Association of Community Cancer Centers in Washington, D.C. Flynn is a medical oncologist and medical director for the Cancer Research Program at Minnesota Oncology, where he has practiced since 1985. Award winners are physicians who have demonstrated leadership in the developPatrick J. Flynn, MD ment, participation, and evaluation of clinical studies and/or who are active in developing new screening, risk assessment, treatment, or supportive care programs for cancer patients. Flynn has engaged in clinical research for many years, having served as principal investigator for many Metro-Minnesota Community Clinical Oncology Program and National Cancer Institute clinical trials. Donald Hughes, MD, a family physician practicing at Riverwood Healthcare Center, Aitkin, has received the 2013 Family Physician of the Year Award from the Minnesota Academy of Family Physicians. In addition to his Donald Hughes, MD practice, Hughes works with the Rural Physician Associate Program each year, travels to Duluth monthly to teach in the Family Practice Residency Program, and is very active in the community, providing medical services at local sporting events and helping to educate athletes and parents about health. Robert Lavey, MD, MPH, has joined the staff of HealthEast as medical director of radiation oncology. Lavey earned his medical degree from Stanford University and his MPH from University of California, Berkeley; he completed his radiation oncology residency at Duke University and his fellowship at Stanford University. Prior to joining HealthEast, Lavey was a professor of oncology at the University of South Robert Lavey, MD, MPH Florida. He specializes in stereotactic radiosurgery; sarcomas; and brain, liver, pancreas, and pediatric tumors. Jon V. Thomas, MD, MBA, has been elected chair of the Federation of State Medical Boards’ (FSMB) board of directors. First appointed to the Minnesota Board of Medical Practice in 2001, Thomas has served in multiple capacities within the FSMB. He practices otolaryngology with Ear, Nose & Throat SpecialtyCare of Minnesota in St. Paul. Lee Wattenberg, MD, a professor in the Department of Laboratory Medicine and Pathology at the University of Minnesota and a researcher in the Carcinogenesis and Chemoprevention Program at the university’s Masonic Cancer Center, has been named an American Association for Cancer Research Academy FelLee Wattenberg, MD low. The Academy honors distinguished scientists whose scientific contributions have resulted in significant innovation and progress in the fight against cancer. Wattenberg is considered the ‘father of chemoprevention,’ having pioneered that field by identifying the protective effects of vitamins A, C, and E and chemicals found in certain vegetables. He continues research to identify agents that can prevent carcinogen-induced lung cancer. Mark Werner, MD Mark Werner, MD, has joined Medica as its senior vice president and chief clinical and innovation officer. Most recently, he was a senior vice president and chief clinical integration officer for Fairview Health Services.
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Cracking the code ■ Genetic counseling is a relatively new field;
what can you tell us about its history?
Beverly Yashar, MS, PhD American Board of Genetic Counseling Beverly Yashar, MS, PhD, is president of the American Board of Genetic Counseling (ABGC) and program director for the University of Michigan’s Genetic Counseling Program. Yashar obtained her PhD in genetics from the University of North Carolina–Chapel Hill and her MS in genetic counseling from the University of Michigan. She has worked in a wide variety of genetics settings, including basic research labs, clinical genetics clinics, and a family studies core. ABGC is the national credentialing body for genetic counselors. There are currently more than 3,000 ABGC-accredited genetic counselors in the United States.
genetic counseling—you would then be referred to pediatric genetics. Then we move into adult-onset diseases. I think the one that people think of easily is Huntington’s disease, but that’s certainly rarer than cardiomyopathies or hereditary cardiomyopathies or hereditary neuromuscular conditions. People who have early-onset cancers or high-recurrence cancers or multiple occurrences, for example breast cancer, those individuals also would come and see a genetic counselor.
Genetic counseling was first formally established as a profession back in 1969. What occurred on that date was the founding of the first genetic counseling program, which was at Sarah Lawrence College in New York City. Discussions about genetic counseling go back to the 1940s. There were three clinical centers in the U.S. that are considered to be the start of genetic medicine. They were here at the University of Michigan in Ann Arbor, Wake Forest in North Carolina, and ■ What are some of the recent scientific advances then at the University of Minnesota, but the forin your field? malization of genetic counseling as a profession We have been identifying genes for syndromes or really occurred in New York in the late 1970s. diagnoses that we didn’t have before rapidly, Technology emerged that allowed us to screen almost on a monthly basis. And we’re developing for genetic disorders so that we could provide a the ability to think about platform from which individugenetic risk for common disals and families could begin to Now we’re thinking eases—like diabetes or cardiothink about their risk for a conabout genetic testing vascular disease, and we rapdition—both for themselves idly will start to see the ability personally and for children that of the healthy. to offer susceptibility testing they may be either carrying for a host of common diseases. during a pregnancy or might be Historically, genetics and genetic counseling contemplating in the future. have been driven by clinical presentation or phenoThat growth arose from collaboration among type before doing genetic testing. We’re moving physicians in the New York area and social workinto an era where people are starting to look at ers and genetic specialists who were working with genetic testing or genotyping first and then looking those physicians. They recognized the need for the to see what could be the clinical issues that could development of this niche; genetic counseling. arise out of that. I think a lot of the discussion at that time was That’s a new paradigm for us. We’re struggling the realization that there was a need for a peer prowith it. It changes the equation a little bit about fessional who would have the genetic expertise and genetic counseling. It means that now we’re thinkwould be able to have conversations on how to ing about genetic testing of the healthy. translate genetics information into language that makes sense for individuals and their families, so ■ Talk a little about biomedical ethics issues raised that they could then make very specific decisions. by the field of genetic counseling. The American Board of Genetics Counseling For us there are always issues around the idea of was then incorporated in 1993 and the mission of who gets the information from a genetic test result. the board is the certification and recertification of Certainly, it’s critical for your patient to get that genetic counselors. information, but the nature of genetics is such that We want everybody to be clear about the the laws of inheritance mean multiple people could genetic service they’re receiving. Given the comhave that same genetic change. Thinking about plexity of the knowledge, it needs to be provided how you move beyond your patient to the family of by experts in the field. the patient is certainly one of our large challenges. ■ What are some of the reasons a person would When we sequence the whole genome, we have see a genetic counselor? information on genes that could be relevant to a person’s health five, 10, 20, and 30 years down the If we start from the beginning, prenatal counseling pike, and thinking about who gets that information certainly is where genetic counseling started as and when they get it has been quite challenging. a profession. A couple might be referred to genetic If we have an adult who might come into a counseling because of concerns about the pregcancer clinic for very specific testing, because of nancy. the new technology we’re moving away from testWe know that certain conditions are more ing single genes to testing panels of genes—or it common in individuals of different ethnicities, so could be cheaper just to do the whole exome. they may be referred to genetic counseling to have Let’s say we then discover there is a genetic a discussion about those risks. change that leads to a condition that has nothing We then move forward to pediatrics. If a child to do with the reason they were referred, let’s say is born with multiple congenital anomalies or is later found to have developmental delay, if multiple Huntington’s disease. Should we share that information, even if it wasn’t relevant to the clinical systems were involved—certainly autism has question that led them into our clinic? started to move into a discussion of genetics and
MINNESOTA PHYSICIAN JUNE 2013
I think we can get our heads around that relatively easily in an adult population. But now let’s push it back and think about prenatal testing or pediatric testing. Our current guidelines recommend that genetic testing in a pediatric population for a condition in which the age of onset would be as an adult should be deferred until that child has the opportunity to decide whether or not they want that information. Who would keep that information? There’s a tension, as you might imagine, within the field about what we should share and who to share it with. For a parent to know, “Oh, I’ve got a child who has a high risk of breast cancer when they’re in their 30s or 40s,”—is that appropriate? That is certainly one of the major issues right now. ■ What are some of the challenges with
direct-to-consumer (DTC) testing? The problem with DTC is that it’s not regulated nor is any genetic testing well regulated. You have to be really clear what type of technology a company is using, how good the coverage is, how much of an effort they make to ensure that people who are participating in the DTC really understand what they’re getting into. Even if we carry things that can be associated with disease, not everybody who has a mutation is going to develop that disease. Now think about moving that into a DTC
2013 CME Activities
One of the major issues is that the development of genetic medicine and genetic counseling is very tightly tied to technology, and countries that don’t have the resources are going to have a very different look at genetic counseling.
format where there’s nobody who’s educating and then interpreting. They’re going to sequence 25,000+ genes. They’re definitely going to find that you’re a carrier for something. Patients get this information and they have no idea what it means. DTC is an incredibly powerful idea, but it needs to be in a format where appropriate education, counseling, and informed consent are obtained before testing is initiated and then appropriate education, counseling, and support are provided once the test results come back.
■ What does the future of genetic
■ Genetic counseling is an international
field—how do approaches to these ethical issues differ globally? That’s a very good question. I am the coeditor of an upcoming edition of the Journal of Genetic Counseling, looking at genetic counseling beyond the Americas. Certainly in Australasia, there is a very large and very active genetics and genetic counseling community. Europe certainly has a large community. How genetic counseling looks in those communities is not drastically different from the way it looks in the U.S. How it looks in Turkey or Saudi Arabia, Taiwan, China is a very, very different game. I think those countries in which the practitioners were trained in the U.S. follow a model that may be closer to a U.S.-based model.
I think the future holds expansion into basically all areas of medicine. That’s the power of being able to map our genome and then utilize that information, not just in a reactive way, but a preventive way. We’re already starting to see genetic counseling as part of cardiology, neurology, ophthalmology, ENT, you name it. As we think about the genetic basis of common complex disease, we’re going to see more and more genetic counselors in that area, and they’re going to be working not just in the traditional roles of being in front of a patient; that’s still going to be critical, but certainly also serving as consultants to physicians, to groups of physicians. As always, we’re looking for where the next new discoveries are coming from the bench—what’s going to be discovered in terms of new ways of genetic testing, new ways of explaining genetic disease. As those come out, we’re very savvy and quite nimble at following new developments and new discoveries.
For a full activity listing, go to www.cmecourses.umn.edu
(All courses in the Twin Cities unless noted)
SEPTEMBER – NOVEMBER Lillehei Symposium: Cardiovascular Care for Primary Care Practitioners September 5-6, 2013 Care Across the Continuum: A Trauma & Critical Care Conference September 27, 2013 NPHTI/Pediatric Clinical Hypnosis October 3-5, 2013 Twin Cities Sports Medicine October 4-5, 2013 Maintenance of Certiﬁcation in Anesthesiology (MOCA) Training October 5, 2013
Psychiatry Review October 7-8, 2013 Got Your Shots? 2013 Immunization Conference October 10-11, 2013 Transplant Immunosuppression 2013 October 16-19, 2013 Practical Dermatology October 25-26, 2013 Donald Gleason Conference on Prostate & Urologic Cancers October 25, 2013 Pediatric Trauma Summit November 1-2, 2013
ONLINE COURSES (CME credit available) www.cme.umn.edu/online U Fetal Alcohol Spectrum Disorders (FASD) - Early Identiﬁcation & Intervention U Global Health - 7 Modules to include Travel Medicine, Refugee & Immigrant Health
Internal Medicine Review & Update November 13-15, 2013 Emerging Infections in Clinical Practice & Public Health: New Developments November 22, 2013
Ofﬁce of Continuing Medical Education 612-626-7600 or 1-800-776-8636 email: firstname.lastname@example.org
Promoting a lifetime of outstanding professional practice JUNE 2013
Being green from cover We might say that the health care industry has an obligation to be more concerned about— and to serve as a model for— responsible environmental management. Many health care organizations have stepped up to the plate. In 2010, Infection Control Today reported that 54 percent of the 5,000+ hospitals in the United States have “green teams,” and that number is growing. But let’s be careful and not sugarcoat this: Health care has a long way to go in its efforts to be environmentally sustainable. As a physician, how can you help? Physicians exert sizable influence within the workplace, and this can go a long way in encouraging a culture of sustainability within health care. This doesn’t necessarily mean you bring granola in your lunch box, wear hemp sweaters, and chain yourself to oak trees in the park. For the mainstream or even weekend environmentalist, this article suggests three topics for potential advocacy: waste reduc-
tion, energy and climate, and toxic chemical reform. Advocacy for waste reduction
According to the Environmental Protection Agency and the American Hospital Association, U.S. hospitals generate about 6,600 tons of waste each day. As much as 80 percent of this is nonhazardous solid waste, offering clinics and hospitals many opportunities for waste reduction. Just stop and think for a moment about how many consumables are used in a clinic or hospital. Questioning the status quo is the best way a physician can
tion to what is being prepared for your procedures; if you don’t use it and don’t need it, please take a moment to tell someone to remove it. At just one hospital, we saved $104,658 and reduced annual waste by 7,792 pounds with tiny tweaks to the physician custom packs. Impact on patients? Zero. This line of thinking can bode well for other reductions, too, such as office paper. One physician recounted that her clinic was faxing her several printed, paper files each day, simply because that’s “how they’d always done it.” She requested electronic delivery and reduced her personal paper consumption dramatically. Physician advocacy opportunity #2: Recycling. Health care facilities toss cans, bottles, glass, newspaper, office paper, cardboard, and more—every day. Do you a have recycling program? Could it be more robust? Many organizations and businesses offer consultant services to aid you in these efforts. Your building management depart-
act on the issue of waste reduction. For example, in working with surgeons at the University of Minnesota Medical Center to reduce disposable items in surgical custom packs, we discovered that nurses were routinely throwing away clean, unused supplies such as plastic basins, gauze, and plastic tubing. When we asked surgeons about the necessity of these supplies, they frequently answered that they were simply unaware that those items were in the pack. Indeed, they had no objections whatsoever to removing them. Physician advocacy opportunity #1: Reduction. Pay atten-
Health care has a long way to go in its efforts to be environmentally sustainable.
BEING GREEN to page 38
You can. Gray Plant Mooty Health Law Group Where others see legal barriers, we see possibilities. Join us at our Health Law Conference on July 11. Visit gpmhealthlaw.com for more details.
MINNESOTA PHYSICIAN JUNE 2013
MINNEAPOLIS 500 IDS Center 80 South Eighth Street Minneapolis, MN 55402
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For adult patients with type 2 diabetes, Victoza® offers these beneﬁts and more. Visit VictozaPro.com/Care to learn how the support program helps patients get started.
*Victoza® 1.2 mg and 1.8 mg when used alone or in combination with OADs. † Victoza® is not indicated for the management of obesity, and weight change was a secondary end point in clinical trials.
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 ﬁrst-line therapy for patients who have inadequate glycemic control on diet and exercise. In clinical trials of Victoza®, there were more cases of pancreatitis with Victoza® than with comparators. Victoza® has not been studied sufﬁciently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza®. Use with caution 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-durationdependent 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 Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.
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® (liraglutide [rDNA origin] injection) or to any of the product components. If pancreatitis is suspected, Victoza® should be discontinued. Victoza® should not be re-initiated if pancreatitis is conﬁrmed. 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 post-marketing, 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 post marketing 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, 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. Please see brief summary of Prescribing Information on adjacent page. 0113-00013301-1
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 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 [see Contraindications and Warnings and Precautions]. 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. In clinical trials of Victoza, there were more cases of pancreatitis with Victoza than with comparators. Victoza has not been studied sufﬁciently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza. Use with caution 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 liraglutideinduced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies [see Boxed Warning, Contraindications]. 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: 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. There are no conclusive data establishing a risk of pancreatitis with Victoza® treatment. After initiation of Victoza®, and after dose increases, 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® and other potentially suspect medications should be discontinued promptly, conﬁrmatory tests should be performed and appropriate management should be initiated. If pancreatitis is conﬁrmed, Victoza® should not be restarted. Use with caution in patients with a history of pancreatitis. 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
MINNESOTA PHYSICIAN JUNE 2013
lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin [see Adverse Reactions]. 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 [see Adverse Reactions]. 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 [see Adverse Reactions]. 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 oncedaily, 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 double-blind 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 Victoza® 1.8 mg once daily + Exenatide 10 mcg twice daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 235 N = 232 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharma® ceuticals, patients treated with Victoza may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the ﬁve double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested 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 0 0 — self−treat Patient able to self−treat 9.7 (0.24) 25.0 (1.66) — Not classiﬁed 1.2 (0.03) 2.4 (0.04) — Glimepiride + Placebo + Metformin Add-on to Metformin Victoza® + Metformin (N = 724) Metformin (N = 121) (N = 242) Patient not able to 0.1 (0.001) 0 0 self−treat Patient able to self−treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) Continued Victoza® None Add-on to Victoza® + Insulin detemir + Metformin Victoza® + Metformin + Metformin alone (N = 163) (N = 158*) Patient not able to 0 0 — self−treat Patient able to self−treat 9.2 (0.29) 1.3 (0.03) — Add-on to Victoza® + Glimepiride Rosiglitazone + Placebo + Glimepiride (N = 695) Glimepiride (N = 231) (N = 114) Glimepiride Patient not able to 0.1 (0.003) 0 0 self−treat 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 + Rosiglitazone None + Rosiglitazone + Rosiglitazone (N = 355) (N = 175) Patient not able to 0 — 0 self−treat 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 = 230) Glimepiride (N = 232) (N = 114) Patient not able to 2.2 (0.06) 0 0 self−treat 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 [see Warnings and Precautions]. 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 [see Warnings and Precautions]; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis [see Warnings and Precautions]; Angioedema and anaphylactic reactions [see Contraindications, Warnings and Precautions] OVERDOSAGE: In a clinical trial, one patient with type 2 diabetes experienced a single overdose of Victoza® 17.4 mg subcutaneous (10 times the maximum recommended dose). Effects of the overdose included severe nausea and vomiting requiring hospitalization. No hypoglycemia was reported. The patient recovered without complications. 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., 100 College Road West, Princeton, New Jersey 08540, 1−877-484-2869 Date of Issue: December 13, 2012 Version: 5 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is a registered trademark of Novo Nordisk A/S. Victoza® is covered by US Patent Nos. 6,268,343; 6,458,924; and 7,235,627 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297; 6,235,004; 6,582,404 and other patents pending. © 2010-2013 Novo Nordisk 0213-00013375-1 2/2013
Cystic fibrosis from cover shows that research targeting a specific genetic defect can lead to more effective treatment of other inherited diseases, too. The nature of the problem
CF is caused by mutations in any of the several loci in the CFTR gene that produce variant CFTR proteins. Mutation produces a defective CFTR protein that causes the body to produce extremely thick, sticky mucus. CF mucus clogs the lungs and leads to life-threatening lung infections. It obstructs the pancreas and stops natural enzymes from helping the body break down and absorb food, which leads to an inability to maintain a healthy weight. Until the discovery of ivacaftor, CF treatment focused on controlling the disease’s hallmark symptoms of cough, mucus production, shortness of breath, and pancreatic insufficiency that causes weight loss. We expend great effort controlling airway infections, which are very common because of the abnormal mucus clearance. We’ve
done pretty well with this, and improved survival significantly. But these are downstream effects of a defective CFTR protein that has lost much of its function. Ivacaftor is the first drug to restore function to that protein. How does CFTR function and how does its dysfunction cause disease? In most people, CFTR functions as a channel that opens and closes to allow chloride to pass from the inside to the outside of the cells lining the airways and other ducts. These chloride ions balance the sodium ions pumped into the airway that together attract water onto the tops of airway-lining cells. A normal depth of the water above the airway-lining cells allows their cilia to move mucus, along with bacteria, molds, and other inhaled particles trapped in the mucus up to the mouth where it is swallowed. When CFTR fails to function, the chloride cannot get through the cell membrane to balance the sodium pumped to the cell surface; there is less sodium chloride to draw water to the cell surface; the depth of the
periciliary fluid layer diminishes; cilia-driven mucus clearance slows or ceases; and bacteria and molds trapped in the mucus have time to grow in the airway. Growing microbes release proteins that attract inflammatory cells to the airway. These cells release enzymes that kill some of these microbes but also injure airway tissue. For patients who have the defective CFTR protein that responds to ivacaftor, this oral drug restores the defective CFTR chloride channel function and presumably the normal movement of mucus out of the airway. As a result, microbes trapped in CF mucus have less time in the airway to reproduce and therefore attract fewer inflammatory cells. This decreases coughing, mucus production, and shortness of breath, allowing patients to gain and maintain much-needed weight. Unraveling the mystery
How was it determined that this particular CFTR protein was abnormal in some CF patients,
and how did we find a drug to fix it? This story starts in the 1900s with Sir William Lawrence and Charles Darwin, who first understood that reproduction produced slight variations in offspring; and with Gregor Mendel’s discovery that different traits were inherited in different, but predictable, patterns. In the 1940s, Avery, McCloud, and McCarty found that deoxyribonucleic acid (DNA) was the chemical that transmitted these inherited patterns from one generation to the next in higher organisms. From their experiments, scientists learned that DNA is the molecular basis of the patterns of inheritance that Mendel discovered; and that variation in DNA transmitted to offspring causes most variation in organ form and function in offspring. These findings provide the basis for our current work to generate more safe and effective treatments of inherited diseases in people. In the 1950s, CF patients were found to have a much higher concentration of sodium
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chloride in their sweat than unaffected people. Studying families affected by CF revealed the autosomal recessive pattern of inheritance described by Mendel. This research allowed Francis Collins, Lap-Chee Tsui, and John Riordan and their collaborators to identify the specific DNA that varied in CF patients. The protein predicted from the DNA sequence was a good candidate for regulating salt movement across cells. This was later confirmed by microinjecting the CFTR DNA sequence into a cultured cell line that normally lacked a transmembrane chloride channel and by showing that expression of the CFTR protein in these cells produced such a channel. These experiments demonstrated that both copies of the CFTR gene were mutated in individuals with CF and not in their relatives. Subsequent research confirmed that cells from the lining of CF patientsâ€™ sweat ducts, airways, or gut showed abnormal functioning of the mutated CFTR protein. Normally, this protein moves chloride from
inside the airway-, gut-, and duct-lining cells to outside the cells. However, in CF patients the cells from the lining of the airways or gut have abnormal function of the CFTR channel that allows chloride to move from inside these cells to the outside. Consequently, in those patients chloride stays in the sweat ducts, resulting in the overly salty sweat characteristic of CF. From research to drug
Once the defective chloride-moving CFTR protein was identified, drugs that could theoretically make it behave more normally could be synthesized. Using a high-throughput screening method, it was now possible to test thousands of drugs already available for treatment of other diseases for their effectiveness on cells that contained a CFTR gene with the most common CFcausing mutation cultured under two different conditions. This testing was accomplished by Vertex Pharmaceuticals with start-up funding from the Cystic Fibrosis Foundation.
Vertex tested the already synthesized drugs for their effect on chloride flow from inside these cells to outside the cells (potentiator drugs). The first drug to be found was ivacaftor, a potentiator drug that increased the transfer rate of chloride from these cells. After preliminary safety testing in laboratory animals, ivacaftorâ€™s effect was tested for safety and effectiveness in humans at the University of Minnesota Cystic Fibrosis Center and at other institutions around the world. These tests showed that ivecaftor effectively increased the chloride flow in certain CF patients (those who have the G551D mutation in the CFTR gene) and brought their sweat chloride concentrations down toward normal. Of greatest importance, it increased the flow of air through their airways and they gained weight compared with placebo treatment. Improved treatment today, hope for the future
What sets the discovery and development of ivacaftor apart
from the usual path of drug development is that it focused on a specific protein whose role in disease was discovered based on an understanding of genes and how they are inherited. It is the way more drugs will be discovered and developed for inherited diseases that today are poorly treatable. We are currently testing another drug that may produce similar improvement in more CF patients. With the help of patients with CF who participate in these clinical trials, we are on the verge of slowing and possibly stopping the progression of the lung disease that shortens the lives of most CF patients. Warren Regelmann, MD, is an associate professor of pediatric pulmonology and infectious diseases at the University of Minnesota, where he is co-director of the Pediatric Pulmonary Division and director of the Pediatric CF Program of the Minnesota CF Center, which is supported by grants from the Cystic Fibrosis Foundation and is one of 13 Translational and Therapeutic Development Centers funded to carry out early-phase clinical trials of new therapies.
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n January 2013, Health and Human Services (HHS) published the long-awaited final rule (the “Final Rule”) implementing changes to HIPAA from 2009’s Health Information Technology for Economic and Clinical Health (HITECH) Act. The 130-plus pages of regulations and corresponding commentary clearly demonstrate that HHS is more committed than ever before to expanding both patients’ privacy rights and the obligations of providers to be proactive in protecting patients’ protected health information (PHI). While the Final Rule provides significant detail on numerous patient privacy and security issues, those of immediate concern to physicians and other providers are in the areas of business associate relationships, breach notification, and notices of privacy practices.
Business associate relationships
Telephone Equipment Distribution (TED) Program
One of the primary areas addressed in the Final Rule concerns business associates and
HIPAA update Final security and privacy regulations will significantly affect physician practices By Timothy Johnson, JD, and Jesse Berg, JD, MPH
their relationship with physicians and other providers. Expanded definition of “business associate.” The Final Rule expands the definition of “business associate” to include any party that “creates, receives, maintains, or transmits” PHI on behalf of a covered entity. HHS clarified that an entity that maintains or stores PHI, regardless of whether it ever accesses the information, would be considered a business associate. Similarly, the Final Rule includes in the definition of business associates entities that primarily transmit PHI, but are provided “routine access” to PHI such as health information organizations and e-prescribing gateways. The Final Rule continues to exclude from the defini-
Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability? If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify. Please contact us, or have your patients call directly, for more information.
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MINNESOTA PHYSICIAN JUNE 2013
tion of business associates those entities that act as mere conduits for the transport of PHI but do not access the information, such as the U.S. Postal Services and courier services. Historically, business associates were only those entities that had access to PHI and contracted directly with covered entities. However, the Final Rule expands the definition of business associate to include downstream entities that perform typical business associate functions involving PHI but have no direct relationship with the covered entity and instead only perform those services on behalf of the business associate that has a direct relationship with the covered entity. Not only are these direct subcontractors to a business associate considered business associates; so are parties that contract with those subcontractors and create, receive, maintain, or transmit PHI on behalf of those subcontractors. Under the Final Rule, this expansion of parties that are considered business associates (to the party with which they contract as a subcontractor) continues as far down as the chain of relationships goes. This expansion of the definition of business associates has important implications for covered entities, business associates, and, especially, those “subcontractors” that in the past may not have been very focused on HIPAA compliance. For example, by including each party that creates, receives, maintains, or transmits PHI downstream as a business associate, the Final Rule requires a party in the chain to have a business associate agreement with each of the subcontractors with which it contracts to perform services on that party’s behalf involving PHI. Furthermore, as a business associate, each subcontractor will be subject to the Final Rule’s
HIPAA compliance obligations for enhanced business associates discussed below. Given this expanded definition of business associates, physician groups will need to re-evaluate which of their vendors are business associates and put updated business associate agreements in place. HIPAA compliance and direct business associates. Prior to the Final Rule, physicians and other providers were required to have business associate agreements with their business associates that required the business associates to be contractually liable to the group in order to comply with many of the Privacy Rule and Security Rule requirements. With the passage of the Final Rule, in addition to being contractually liability to the covered entities, business associates will now be directly responsible for compliance with many provisions of the HIPAA rules. For example, under the Final Rule, business associates will be required to comply with the HIPAA Security Rule in the same manner as a “covered entity.” Likewise, business associates will be required to comply with some, but not all, of the provisions of the Privacy Rule. Being directly responsible for compliance with the Security Rule, and many provisions of the Privacy Rule, means that business associates, including the subcontractors who will themselves be regulated as business associates, can be potentially liable for civil and criminal penalties for noncompliance with such requirements. Updates to business associate agreements. The Final Rule makes it clear that its various changes to the definition and obligations of business associates, along with their relationships with providers, will require the providers to amend and update existing business associate agreements. Fortunately, the Final Rule gives some latitude on the timetable for providers to update existing agreements. Generally, business associate agreements that were in effect as of Jan. 25, 2013, will not have to be updated until Sept. 22, 2014. However, for all new business associate agreements that are
executed after Jan. 25, 2013, and for any modification or renewal of existing business associate agreements, the business associate agreements must comply with the Final Rule requirements by Sept. 23, 2013. Breach notification rule
The Final Rule also issues new guidance about when covered entities are required to notify their patients in the event of a breach (defined as an unauthorized acquisition, access, use, or disclosure, of patients’ PHI). Historically, HIPAA provided that a covered entity was required to notify the patients only if the patients’ PHI was unsecured and the breach of the PHI presented a significant risk of financial, reputational, or other harm to the patient. However, the Final Rule replaces that standard with a much stricter one. Specifically, any incident involving the unauthorized acquisition, access, use, or disclosure of PHI is presumed to be a breach and the affected patients must be notified unless the covered entity performs a
risk assessment and is able to demonstrate that there is a low probability that the patients’ PHI was compromised. Revisions to notices of privacy practices
As a result of modifications to various Privacy and Security Rule provisions included in the Final Rule, all covered entities will be required to update their notices of privacy practices (NPP) to reflect the new changes. For example, in addition to describing the breach notification process discussed above, the NPP must disclose the Final Rule’s expansion of a patient’s right to restrict disclosures and the types of uses and disclosures of PHI that require individual authorization. The Final Rule requires that physician groups begin providing the updated NPP to patients prior to Sept. 23, 2013. Preparing for new HIPAA requirements
The Final Rule provides that covered entities that breach the Privacy Rule can be fined up to
$1.5 million per each occurrence. However, the Final Rule also provides that in assessing penalties for HIPAA violations, the HHS Secretary may take into consideration the practice’s efforts in complying with the HIPAA requirements. To help demonstrate a practice’s compliance, it is recommended that physicians groups initially focus on the following four areas: 1. Business associate relationships. Given the Final Rule’s expansion of both who is a business associate and enhanced legal HIPAA exposure for business associates, physician practices should ensure that they have updated business associate agreements with all applicable business associates and that the practice’s business associates are aware of their HIPAA obligations and are operating accordingly. 2. Notice of privacy practices. Physician practices should amend and modify their NPP to comply with the new Final Rule requirements.
3. Security assessment. Given the enhanced obligation under the Final Rule to report HIPAA breaches, practices should perform an assessment of their operations and make changes to minimize the risk of reportable HIPAA breaches. Such changes could include encrypting PHI when possible, performing workforce training on the need to keep PHI secure, and changing practices that present risk of HIPAA breaches, such as prohibiting everyone, including practice physicians, from removing patient PHI from the office or placing electronic PHI on personal computers. 4. Policies and procedures. Update practice HIPAA policies and procedures to comply with the requirements under the Final Rule. Timothy Johnson, JD, and Jesse Berg, JD, MPH, are principals at Gray Plant Mooty, specializing in health care law. They will discuss the new HIPAA requirements at their annual Health Law Seminar at the Metropolitan on Thursday, July 11.
Thursday, July 18, 2013 9:00 am - 4:00 pm
Participants will: • Learn current progress, findings, and best practices from Minnesota's advance care planning programs • Learn from experts in the field about professional and community perspectives in advance care planning • Be inspired with collective ACP stories and testimonies • Gain additional knowledge on ACP evaluation and outcome measurement • Have the opportunity to develop new professional relationships with other health, human service and community-based professionals • Hear keynotes Penny Wheeler, MD, CCO, Allina Hospitals and Clinics and Michele Kimball, Director, AARP Minnesota • Plus much more
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This year's conference promises to be a special day of exploration and discovery . . . one you will not want to miss.
For more informaton: email@example.com
Registration opens June 3rd (www.metrodoctors.com) Registration Fee: $150
PLAN TO ATTEND... Honoring Choices Minnesota 4th Annual Sharing the Experience Conference
ver the past decade, physicians and other health care providers have referenced the 2002 “Kidney Disease: Outcomes Quality Initiative (KDOQI) Clinical Practice Guidelines for Chronic Kidney Disease (CKD): Evaluation, Classification, and Stratification” to help direct the care of patients with kidney dysfunction. The 2012 “Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease” updates the original KDOQI guidelines. The new guidelines may be downloaded at www.kdigo.org/clinical_practice_ guidelines/ckd.php. We present a patient case and a summary of the new guidelines to assist primary care physicians in identifying, classifying, and treating patients with non-dialysis-dependent CKD with or without diabetes. A multidisciplinary approach (primary care, nephrology, pharmacy) to managing CKD progression and complications can help improve
Chronic kidney disease An updated approach to identification, classification, and management By Nathan T. Blake, PharmD, and Wendy L. St. Peter, PharmD
patient understanding and clinical outcomes. A common patient case
Bob, a 79-year-old non-Hispanic Caucasian man, is seen at a local chain pharmacy for a comprehensive medication review. Comprehensive medication review is part of medication therapy management (MTM), a health care service often provided by specially trained pharmacists to optimize medication regimens. Bob and the pharmacist discuss Bob’s prescriptions and over-thecounter medications. Bob’s medical conditions include: • CKD (stage unknown) • Hypertension • Congestive heart failure (CHF) • Dyslipidemia
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• Atrial fibrillation • History of myocardial infarction (stent placement, four years ago) • Asthma • Gastroesophageal reflux disease • Macular degeneration Bob has no questions or concerns about his medication regimen. When he recently saw his primary care practitioner (PCP), his systolic blood pressure was elevated to 180 mmHg, and the PCP mentioned labored breathing and mild edema. His PCP made no medication changes. Though Bob’s electronic medical record lists CKD as a problem, Bob does not recall ever seeing a nephrologist or receiving an angiotensin-converting enzyme-inhibitor (ACE-I) or angiotensin receptor blocker (ARB). Bob and the pharmacist discuss benefits and risks of ACE-I/ARB therapies for reducing risk of CKD progression and other medical conditions. With Bob’s consent, the pharmacist contacts the PCP to discuss whether ACE-I/ARB therapy would be beneficial for Bob’s hypertension, CHF, and kidney function. From the PCP, the pharmacist learns that Bob was hospitalized last year for CHF and subsequent acute kidney injury (AKI); a nephrology consult note indicated a decision not to initiate ACE-I/ARB therapy at that time. Given this history, the PCP was hesitant to initiate ACE-I/ ARB therapy despite Bob’s recovery from the AKI episode. The pharmacist provides the PCP with a rationale for initiating ACE-I/ARB therapy, and discusses monitoring parameters and potential benefits and risks. The PCP decides not to initiate ACE-I/ARB therapy due to concerns about potential hyperkalemia and the possibility of fur-
ther decreasing kidney function. Although the KDIGO guidelines are not intended as an exclusive prescribing template, they can aid in the decisionmaking process for patients like Bob by providing graded recommendations based on best available evidence. Updated CKD guideline summary
The KDIGO definition of CKD is the same as in the original KDOQI guidelines: abnormalities in kidney structure or function, present for more than three months, with implications for health. However, the new guidelines enhance classification, identification, and prognostication of kidney function through the CGA classification system, which identifies cause (C), glomerular filtration rate (GFR) category (G), and albuminuria category (A). KDOQI highlighted the pitfalls of using serum creatinine alone to assess kidney function and set a standard for physicians to use GFR estimating equations to obtain more accurate estimates of GFR. The two equations advocated were the Modification of Diet in Renal Disease Study and the Cockcroft-Gault equations; both take into account additional patient factors that influence GFR. The new KDIGO guidelines recommend using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for staging CKD for better accuracy in patients with higher GFRs. Electronic versions of these equations can be found at www.kidney.org/professionals /kdoqi/gfr_calculator.cfm, and printed versions on pages 7–8 of the KDIGO guidelines. KDIGO guidelines further define the GFR categories (see Table 1 on page 42). Albumin, as the primary component of urinary protein in kidney diseases, serves as an early indicator of glomerular damage, often before a decrease in kidney function can be appreciated. Albuminuria classification is based on the albumin excretion rate (AER; see Table 2 on page 42).
Guidelines on blood pressure goals for CKD patients By collectively considering GFR and AER (and cause of kidney disease), physicians can determine classification, treatment priorities, and prognostication of kidney disease (refer to the figure on page 21 of the KDIGO guidelines). Managing blood pressure in patients with CKD
New blood pressure (BP) goals and treatment guidelines can help providers select appropriate treatment regimens. KDIGO encourages providers to individualize BP goals and treatment based on age, cardiovascular disease, other comorbidity, risk of CKD progression, retinopathy (for patients with diabetes), and treatment tolerance. The BP target is generally ≤140/90 mmHg for patients with non-dialysisdependent CKD with or without diabetes and AER <30 mg/24 hours. If AER ≥30 mg/24 hours, the target BP recommendation is ≤130/80 mmHg (for both diabetic and nondiabetic patients). Guidelines now recommend initiating ACE-I/ARB therapy for diabetic and nondiabetic patients with non-dialysis-dependent CKD in whom BP-lowering agents are indicated if AER ≥30 mg/24 hours. Decisions regarding choice of BP-lowering agent for patients with AER <30 mg/24 hours should be individualized. The renin-angiotensin system (RAS) plays a significant role in BP regulation in CKD patients; it can increase intraglomerular pressure by constricting the efferent arteriole via increasing angiotensin II. Blocking angiotensin II with an ACE-I or ARB relaxes the efferent arteriole, reduces intraglomerular pressure and albuminuria, and protects kidney function over time. Therefore, medications that target the RAS system (most evidence is with ACE-I/ ARBs) should be considered in CKD treatment regimens. ACE-I/ARBs are indicated for patients with AER ≥30 mg/24 and can be combined with other BP-lowering medications. Close monitoring upon initiation and dose escalations is prudent due to the potential for hyperkalemia and initial GFR decreases, especially in patients with renalartery stenosis or intravascular
• A BP goal of ≤130/80 mmHg may be reasonable for many patients with CKD and AER ≥30 mg/24 hours, but a higher goal (e.g., ≤140/90 mmHg) may be appropriate for elderly patients or those with significant cardiovascular disease; individualize the BP goal for patients with AER <30 mg/24 hours (or equivalent). • Consider use of ACE-Is or ARBs as single-agent primary therapy in CKD patients with AER ≥30 mg/24 hours (or equivalent). • Do not institute dual RAS therapy except under the care or recommendation of a specialist (endocrinologist, nephrologist, diabetologist). • Do not initiate RAS therapy in patients with potassium >5.5 mEq/L or with diagnosed or suspected bilateral renal artery stenosis. • Assess serum creatinine and serum potassium before ACE-I/ARB initiation and with each dose increase. • Initiate using lowest ACEI/ARB doses; consider halving the lowest dose in patients at high risk for RASagent-induced AKI (elderly, diuretic use, dehydrated, atherosclerosis). • Maximize the ACE-I/ARB dose by titrating up as frequently as every 2 to 4 weeks until maximal dose is achieved or hypotension or other adverse effect occurs (see potassium and serum creatinine monitorvolume depletion (or taking diuretics), or when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, or potassium-sparing diuretics. No substantive evidence suggests that ACE-Is are superior to ARBs regarding BPor albuminuria-lowering effects. ACE-Is are generally initiated first due to lower costs. If a cough arises with ACE-I use, an ARB can be substituted. Combining an ACE-I and an ARB to lower BP or preserve kidney function is not recommended; combination use increases the risk of progression of kidney failure and other adverse reactions (hyperkalemia, hypotension), according to recent findings from the ONTARGET and ALTITUDE clinical trials. RAS agents are beneficial in reducing progression of kidney disease, but inappropriate dosing or lack of close monitoring can cause kidney dysfunction. The sidebar (above) provides a practical guide for safe and effective use of RAS agents in CKD patients. Medication combinations including a potassium-losing diuretic (in general, thiazide diuretic if estimated GFR is above 30 mL/min/1.73 m2 or loop diuretic if estimated GFR is below that level) may help prevent hyperkalemia and provide a
ing guidelines below). • Reassess potassium and serum creatinine within 2 weeks of initiating a RAS agent or dose increase. - Regarding change in serum creatinine levels: o If dose is tolerated with ≤30% increase from baseline serum creatinine or ≤30% increase from baseline estimated GFR, then consider dose increase. o If serum creatinine increases >30% from baseline or estimated GFR is reduced >30% from baseline anytime within 4 months of RAS initiation, decrease dose (or stop RAS agent if at lowest dose). - Regarding serum potassium levels: o If potassium level is at or increases to 5.0 mEq/L, prescribe a low-potassium diet. o If potassium increases to 5.5 mEq/L, measures such as adjustment in diuretics, administration of long-term alkali supplements, liberalizing salt intake, or long-term use of low-dose sodium polystyrene sulfonate may be indicated. o If potassium increases to ≥6.0–<6.5 mEq/L, stop RAS agent and reinstitute at 50% of prior dose when potassium <5.5 mEq/L. o If potassium increases to ≥6.5 mEq/L, permanently discontinue RAS agent.
concomitant BP-lowering effect. If a patient established on a RAS-blocking medication becomes acutely ill or requires short-term therapy with NSAIDs, dose reductions or temporary discontinuation of the
RAS blocking agent may be advised to reduce the risk of AKI. RAS-blocking therapy can resume upon recovery or discontinuation of the NSAID. KIDNEY DISEASE to page 42
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medical clinics planning to relocate or expand; and the importance of including medical staff in the planning and design process for new or remodeled health-care facilities.
Everyone cares about
Increasing demand for ER care cut that requires stitches, a broken arm, heart Use of emergency rooms nationattack symptoms â€Ś it wide has increased 26 percent used to be that anyone suffering since 1997, to these ailments about 114 million would head annually, Use of emergency patients directly to the according to the nearest hospital rooms nationwide Centers for Disemergency room ease Control and has increased (ER). But today, Prevention (CDC). the ER isnâ€™t the This increased 26 percent only option for demand for ER patients. Many services gives rise since 1997. are trying a faster, to frustration for less expensive both physicians and patients option for acute care closer because of long waits in the to home: the freestanding lobby, long waits for test results, emergency/urgency room. and other inefficiencies. Emergency physicians have been saying for years that we could do better if we had operational control over the environment, and that we could work out common ER problems to make emergency care faster, better, and more efficient. This is what motivated the Emergency Physicians Professional Association (EPPA) to develop the Urgency Room (UR), the first stand-alone ER type of facility in Minnesota. EPPA is a locally based group of board-certified ER physicians who provide ER physician staffing in five Twin Cities hospitals.
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By Gary Gosewisch, MD
clinic development considerations for
A new option for acute-care services, at reduced cost, and closer to home
fessionals can play in and management;
Freestanding â€œurgency roomâ€? facilities
focus articles discuss
facilities; the advoca-
MINNESOTA PHYSICIAN JUNE 2013
The need for an ER alternative
Recent health care reforms have provided a strong impetus to develop health care networks that offer more connected and comprehensive care among all physicians and patients. However, the idea of a standalone ER facility surfaced about a decade ago, initially as a way to bring ER-level treatment to towns and communities without easy access to this type of care.
The aim was, and is, to provide patients with the same care that they would find in a hospitalbased emergency room, the difference being that the time to be seen, treated, and on their way is much reducedâ€”as is the cost. In late 2011, an article in the Washington Post reported there were at least 222 freestanding ER facilities in the U.S., operating in 16 states. The same article noted that Seattle has several freestanding emergency rooms, including one an hour north of the city that has more square footage than an NFL football field. The lure of stand-alone emergency departments is also rooted in a growing consumer demand for convenience in health care delivery, as evidenced by the growing number of clinics staffed by nurses in supermarkets and doctor-owned urgent care centers. In addition, many procedures have already moved out of the hospital because they can be handled more efficiently in other settings where resources for certain procedures can be dedicated in a specific way. For example, colonoscopies, which are regularly performed at gastroenterology centers today, could be performed only in hospitals just 10 years ago. Spine surgeries, LASIK, pediatric tonsillectomies, plastic surgery, and many other surgical procedures also, for the most part, are done at surgery centers now. Services delivered
Stand-alone ERs are designed to treat a variety of medical conditions. At the three Urgency Room locations in the Twin Cities, board-certified physicians and emergency medicine-trained nurses and paramedics have treated a wide range of conditions, from broken bones and serious lacerations to blood clots and heart attack symptoms. In fact, EPPAâ€™s research on ER admissions in five Twin Cities hospital-based ERs since 2001 shows that in Minnesota, roughly 75 percent of patients who go to the ER for care arenâ€™t admitted to the hospital and donâ€™t need hospital-based services. Thereâ€™s no need for those
people to endure hours of waiting, uncertainty over what is going on with their case, and anxiety about the financial costs. Going to the ER for acute and urgent medical needs is no longer the only option for patients in the Twin Cities and in many parts of the country. Instead of a mom waiting four hours to get five stitches for her child at the ER, her child can receive the same expert medical treatment much faster in an environment that is welcoming and comfortable. Urgency Room patients are treated quickly in a comforting environment by board-certified emergency physicians and avoid the hassle of an ER visit. Urgency Room facilities also provide a high level of amenities and service, in marked contrast to the atmosphere of a typical hospital-based ER. Patients are greeted by friendly, courteous staff whose priority is to put patients at ease and make them comfortable. We always keep patients informed of how long the wait will be and where they are in the process. An LCD screen in the lobby lists wait times, which are also accessible via the Urgency Room website. Patients can even go online and enter their name into the system before arriving at the facility, so staff will be ready for them. If the wait time is longer than normal, patients may leave to run errands or entertain their children outside without losing their place in line; we call or text the patient when a room is ready. The discharge process at the Urgency Room is also quick and easy; our goal is to get our patients treated, home, and on their way to recovery fast. The Urgency Room also makes arrangements with local hospitals to have expedited admissions when a trip to the operating room or a hospital stay is needed. When they get there, patients typically can go directly to their hospital bed or the operating room without having to be seen or wait in the ER. Our goal is to return our patients to their primary care provider for their regularly scheduled care post-treatment at the Urgency Room. We work
How are alternative â€œurgency roomâ€? facilities different from urgent care clinics and hospital emergency departments? Stand-alone facilities that offer emergency medical care differ from urgent care facilities because they provide ER-level care from the same doctors, nurses, and paramedics found in the ER. Urgent care facilities do not provide this level of care; rather, they basically offer the same services as a primary care clinic, except on a walk-in basis and at extended and weekend hours. The new emergency care facilities such as the EPPAâ€™s Urgency Room differ from traditional hospital-based ERs in that they do not accept ambulances. with our patients and with surrounding clinics and physician groups to make sure coordination of care is fulfilled and
For example, the Urgency Room does not accept ambulances, which can alter ER wait times because ambulance-transported
Going to the ER for acute and urgent medical needs is no longer the only option for patients in the Twin Cities and in many parts of the country. patient information is transferred accordingly. Patients can return to their primary or specialty provider following their visit with any necessary records or images from their visit to the Urgency Room. Advantages of the emerging ER alternatives
Reduced cost and wait times were our goals in the creation and execution of the three Urgency Room locations in the Twin Cities. Cost is a key factor. For Urgency Room patients with major health insurance, weâ€™ve negotiated for them to have an urgent care (rather than emergency care) copay. This means that these patients are getting ER-level staff and evaluations, but theyâ€™re paying less for the same treatment. The Urgency Room does not have the overhead and associated costs found in a standard ER attached to a hospital. We are able to keep costs affordable for patients, providers, and insurers. Wait time is the other big draw of freestanding ERs. At the Urgency Room we have the same equipment as an ER, but weâ€™re dedicated only to the patients in the building, so we donâ€™t have the kind of delays that result when resources are dedicated to the hospital overall.
it. Since our first facility, in Woodbury, opened in October 2010, our patient satisfaction rate has been 99 percent. Based on that success, we have since opened locations in Eagan and in Vadnais Heights, and we will continue to expand this innovative concept to communities across the metro area. In the meantime, other urgency care facilities have sprung up in the Twin Cities area. As health care professionals, organizations, and patients look ever more closely at ways to reduce costs while improving care, efficiency, and the patient experience, we can expect this model to be adopted more widely nationwide. Gary Gosewisch, MD, is board-certified in emergency medicine and is an emergency physician at the Urgency Rooms and at Fairview Southdale Hospital.
patients often receive priority care based on the severity of their condition. Our freestanding ER alternative has been very well received by those who have used
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