Minnesota Physician December 2013 by Minnesota Physician Publishing

Vo l u m e x x v i i , N o . 9 D e c e m b e r 2 013

Monitoring prescription drugs Minnesota takes aim at problems of misuse and abuse By Barbara A. Carter

rescription drug abuse is the nation’s fastest-growing drug problem and in 2011 was classified as an epidemic by the Centers for Disease Control and Prevention. Minnesota’s Prescription Monitoring Program (MN PMP), which is administered by the Minnesota Board of Pharmacy (BOP), has been operational since January 2010 and continues to collect records of prescriptions for controlled substances dispensed in or into Minnesota; more than 7 million prescriptions are reported each year. Reporting of data is required from in-state pharmacies and other dispensers, including prescribers who dispense controlled substances, and from out-of-state pharmacies that ship controlled substances to Minnesota residents.

Not “part of the job” Managing patients’ aggressive behaviors

By Joy Plamann, MBA, RN, BC, and Holly C. Peterson, MD, SFHM

nurse walks into a patient’s room. It is clear the patient is upset and agitated. When the nurse asks a probing question, the patient begins swearing at her. The nurse has to duck to avoid the remote control the patient throws at her. A laboratory phlebotomist describes the blood sampling process to a patient and then begins the procedure. Upon the first stick, the patient lashes out, striking the phlebotomist in the face. A physician has been following a patient for a few days in the hospital setting. The patient has been demanding, and has not followed through on all aspects of care that have been advised in the past. The physician begins to discuss the patient’s discharge, which is being planned for the next day. The patient begins yelling and threatening the physician, bellowing, “I’m going to Not “part of the job” to page 10

This article describes the program, how it can benefit prescribers, how prescribers can register for and access the data, recent system improvements, and future direction. Background Minnesota is one of 49 states to monitor controlled substance prescriptions. The Minnesota Prescription Monitoring Program collects data Monitoring prescription drugs to page 12

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CONTENTS

December 2013 • Volume XXVII, No. 9

Features Not “part of the job” 1 Managing patients’ aggressive behaviors

MINNESOTA HEALTH CARE ROUNDTABLE

By Joy Plamann, MBA, RN, BC, and Holly C. Peterson, MD, SFHM

Monitoring prescription drugs Minnesota takes aim at problems of misuse and abuse

By Barbara A. Carter

Departments Capsules

Medicus

Interview

Rahul Koranne, MD, MBA, FACP

HealthEast Care System

Urology

Urinary incontinence By Ron Mjanger, MD

Oral health

Dentistry and medicine By Nelson L. Rhodus, DMD, MPH, FICD

genetics and genomics

“Incidental findings” By Charles E. Gessert, MD, MPH, and Catherine A. McCarty, PhD, MPH

24 FORTy-FIRST SESSION

Post-acute care

professional update Pain medicine Battling the opioid epidemic By Rohaan Mehta, MD

Fixing cracks in the system

Orthopedics 16 Total ankle replacement 18 By J. Chris Coetzee, MD

1:00–4:00 PM, Symphony Ballroom Downtown Minneapolis Hilton and Towers

Special focus: Senior care The integrated therapy 20 Architecture for aging By John W. Gould, AIA model By Kristy Brown, MS, CCC-SLP

Thursday, April 17, 2014

The Independent Medical Business Newspaper

www.mppub.com Publisher Mike Starnes mstarnes@mppub.com Senior Editor Donna Ahrens dahrens@mppub.com ASsociate Editor Janet Cass jcass@mppub.com

Objectives: We will discuss the evolution of post-acute care and illustrate the dynamic potential it holds. From the hospital to the physician to skilled nursing, rehab, and home care, we will present perspectives from across the care continuum. We will investigate communication problems between care team members and present potential solutions. We will examine how elements of health care reform like ACOs and insurance exchanges can drive both improvement in and higher utilization of post-acute care. We will discuss the tools that are necessary for post-acute care to reach its full potential.

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Office Administrator Amanda Marlow amarlow@mppub.com Account Executive Iain Kane ikane@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@ mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not neccessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business or other professional advice and counsel. No part of the publication may be reprinted or reproduced within written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.

Background and focus: Postacute care is becoming an increasingly important component of health care delivery. It is also becoming increasingly community-based. Medical advances are dramatically expanding the range of access to these services and, at the same time, creating a larger number of problems providing them. Choppy access to electronic medical records and ensuing medication management complications, as well as problems with care team coordination, can impede the goal of improving outcomes while lowering costs.

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Capsules

U of M Medical Center Opens Hybrid Operating Room The University of Minnesota (U of M) Medical Center, Fairview has opened a new hybrid operating room that integrates cardiac and vascular surgery, cardiology, interventional radiology, and anesthesia services. It offers technology that can assist a range of procedures, from minimally invasive surgeries to complex, invasive operations. “This hybrid operating room is where clinical providers from across cardiovascular subspecialties can work together to provide the safest, most advanced, and most innovative care available in the nation,” said Steven Santilli, MD, PhD, vascular surgeon at the U of M Medical Center and part of the team that developed the operating room in partnership with Philips Healthcare. U of M officials say the new operating room’s X-ray machine

produces 70 percent less radiation than a traditional machine, which means less exposure during procedures involving X-rays, ultrasound, and echo technologies that help reduce or eliminate surgical incisions. They add that some procedures will take less time to perform because surgeons have access to these tools in one room, and that the ability to perform less invasive operations will mean shorter recovery times for patients.

Children’s to Develop New Facility In Woodbury Children’s Hospitals and Clinics of Minnesota will leave its current location at the Woodwinds Health Campus in Woodbury and move into a new 20,000square-foot space in the Tamarack Hills development in fall of 2014. The new facility will be built in the development that already houses a hotel, restau-

rant, and office space. “The services offered will initially include endocrinology and diabetes, occupational therapy, physical therapy, and speech language pathology—all currently offered at Woodwinds,” said Justin Theodotou, Children’s spokesman. “Children’s will be leasing all 20,000 square feet in the new building, but will initially only use 15,000 square feet. This gives us the capacity to expand out services, but we have yet to determine how we will do so.” MSP Commercial is the developer for the project, and the Woodbury city planning commission approved its site plan at a meeting on Nov. 4.

DHS to Disqualify Nurses with Criminal Histories As many as 107 Minnesota nurses could be banned from providing direct care to patients following a review by the

state Department of Human Services (DHS). In October, the Star Tribune alerted the agency to 294 cases of actively licensed nurses who should be disqualified from working with patients under state law because of convictions for crimes such as criminal sexual misconduct, assault, and fraud. In the review, DHS found that about a third of these nurses had not been disqualified. According to DHS Inspector General Jerry Kerber, the agency was not aware of the criminal histories due to gaps in its background check system. Currently, DHS relies on criminal records managed by the Bureau of Criminal Apprehension, which do not disclose some misdemeanors that would cause disqualification. The Star Tribune’s report compared the list of actively licensed nurses to Minnesota Court Information System (MNCIS) records, which does list these crimes. According to officials, DHS will start using the MNCIS records. Kerber claimed that the nurses in question escaped

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Minnesota Physician December 2013

notice for their crimes because DHS performed only one background check on many caregivers and counted on employers and probation officers to report new criminal activity, which, in many cases, did not occur. Nurses disqualified from providing direct care are not allowed to administer treatment, counseling, training, or medication assistance in hospitals, home health agencies, nursing homes, assisted living centers, and other facilities licensed by the state for seven years to life, depending on the severity of the crime. The Minnesota Board of Nursing, which does not currently perform criminal background checks on nurses, has taken action against 31 of the nurses included in the Star Tribune’s report. Currently, the board relies on applicant disclosure when requesting a license. However, due to a recent change in state law, it will start requesting background checks on new nursing applicants next year, though currently licensed nurses will be exempt from the process. Officials say the board must come up with a plan to check active care provider backgrounds by 2017.

State Scores “B” on Premature Birth Rate Report Card The state of Minnesota scored a “B” on the March of Dimes’ annual Premature Birth Report Card, released on Nov. 1. This is the same grade it received last year. Though Minnesota outranked several states, and the country overall, which received a “C,” the rate of premature births was higher than the rate from the previous year’s report. Premature births, defined as those that happen before 37 weeks of pregnancy, are considered a serious public health issue because of the increased risk of issues like lung damage, brain hemorrhages, infections, vision loss, and cerebral palsy. The cost to the U.S. economy is significant as well. According to the Institute of Medicine, premature births cost the nation $26 billion each year, and the March of Dimes says in the report that it is a lead-

ing cause of increasing health insurance costs. Data in the report are based on information from government sources, including the National Center for Health Statistics, the U.S. Census Bureau, and the Centers for Disease Control and Prevention. This new report reflects statistics from 2012. According to the report, Minnesota had a premature birth rate of 10.2 percent in 2012, compared to 9.6 percent in 2011. Native Americans showed the highest rate of preterm births at 13 percent, followed by non-Hispanic blacks at a rate of 12.7 percent, Hispanics at 10.5 percent, Asians at 10 percent, and non-Hispanic whites at 9.4 percent. The March of Dimes notes in the report that nationally, premature birth rates have a tendency to be higher among Native Americans and nonHispanic blacks, mainly due to disparities in health and health care accessibility. Eighteen other states, including Wisconsin, South Dakota, and North Dakota, also received a “B” rating. Six states received an “A” rating; 17 scored a “C”; five got a “D”; and three states, along with Puerto Rico, scored an “F.”

Initiative Launched To Improve Stroke Care in Rural Areas Recognizing that stroke continues to be a leading cause of death, Minnesota is set to launch an effort in 2014 to improve care and outcomes for stroke patients. Albert Tsai, PhD, MPH, director of the Minnesota Stroke Registry Program at the Minnesota Department of Health, says that the goal of the Minnesota Acute Stroke System is to ensure that stroke victims have access to the best treatment available regardless of where they are in the state. Though there are already hospitals in Duluth, Rochester, St. Cloud, and the metro area certified as primary stroke centers, Tsai said that there are still many

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Capsules from page 5

areas without immediate access to that high level of care. “The idea behind the system is that we are going to be recognizing and designating hospitals who have the capacities and the capabilities that define a hospital that is ready to take care of a stroke,” said Tsai. “About a third of stroke patients first go to a rural hospital when they have a stroke. That’s not an insignificant number, and so we want to make sure that patients in those communities have access to high quality and appropriate care for acute stroke.” Tsai said that the second phase of the program will address ambulance and EMT staff and putting protocols in place to clarify the role they play in the treatment of a stroke patient. He also noted that an important aspect of the program includes educating the public about stroke symptoms for early intervention.

Health Companies Honored at 2013 Tekne Awards The Minnesota High Tech Association (MHTA) honored 15 Minnesota businesses and organizations for advances in technology and innovation at the 2013 Tekne Awards ceremony on Nov. 7. Three awards went to companies in the health care industry for their technological breakthroughs. Bloomington-based HealthPartners was honored with the Healthcare Delivery (established company) award for its online clinic, Virtuwell. The award for Healthcare Delivery (small and growing company) went to Corventis, Inc., a St. Paul-based company that designs and develops solutions to help cardiac patients and physicians, for innovations in the detection and management of cardiac arrhythmia with the use of its NUVANT Mobile Cardiac Telemetry System.

Boston Scientific, which has locations in Maple Grove, Plymouth, and St. Paul, received the Innovation Collaboration of the Year award for its partnership with the University of Minnesota and Universitybased hospitals and clinics to identify unmet clinical needs in different spaces.

Report Analyzes Hospitals’ Mortality, Complication Rates Mortality and complication rates vary widely in hospitals across the nation, and within those operating in a specific region, according to a report recently released by quality reporting company Healthgrades. For its “American Hospital Quality Outcomes 2014: Report to the Nation,” the company analyzed three years of Medicare outcomes data, including 40 million patient records from 4,500 U.S. hospitals. Hospital performance relative to each

of 31 common conditions and procedures was assessed. The report found that a patient’s odds of suffering complications or death are substantially greater at hospitals with a one-star Healthgrades rating compared to hospitals with a five-star rating. Officials estimate that 234,252 lives could potentially be saved and 157,418 complications could be avoided each year if all hospitals performed similarly to the highest rated hospitals. At Twin Cities hospitals, mortality and complication rates varied widely for several procedures and conditions. The largest discrepancies were found in risk-adjusted mortality rates for sepsis, which ranged between 5.5 percent and 44.4 percent; stroke (0.0 percent–9.8 percent); and chronic obstructive pulmonary disease (0.0 percent–8.9 percent). Risk-adjusted in-hospital complication rates varied the most for hip replacement surgery, ranging from 3.2 percent to 25.6 percent.

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Medicus Ellen Abeln, MD, board-certified in radiology, has been inducted as a fellow into the American College of Radiology. She is medical director of the Breast Center of Suburban Imaging, Coon Rapids, and is on staff at Unity and Mercy Hospitals. Abeln earned her medical degree from the University of Minnesota. Her residency in diagnostic radiology and fellowship in cross-sectional imaging were served at the Cleveland Clinic.

Nancy Hutchison, MD, physical medicine and rehabilitation (PMR) specialist and medical director of cancer rehabilitation and survivorship for the Virginia Piper Cancer Institute and Courage Kenny Rehabilitation Institute, Minneapolis, has received the Minnesota nonprofit Breast Cancer Awareness Association’s annual award for outstanding contribution to the breast cancer Nancy Hutchison, community. She completed medical school at MD Wake Forest University in Winston-Salem, N.C., and PMR residency at the University of Minnesota.

Dr. Hutchison photo credit Bruce Silcox

Brian Engdahl, PhD, a professor of neuroscience, cognitive science, and psychology at the University of Minnesota Brain Sciences Center and a psychologist and clinician investigator at the Minneapolis VA Medical Center, has been appointed the Anderson Chair in Post-Traumatic Stress Disorder (PTSD) Research at the U of M Medical School. With Apostolos Georgopoulos, MD, PhD, and colleagues at the center, Engdahl recently helped discover that a special brain scan can identify, with 95 percent accuracy, veterans with PTSD.

J. Brooks Jackson, MD, MBA, has been named the University of Minnesota Medical School’s new dean and vice president for health sciences. Jackson earned a medical degree from Dartmouth Medical School and an MBA at Dartmouth College, both in Hanover, N.H., and served a clinical pathology residency at the University of Minnesota. Internationally recognized for his research in HIV, he J. Brooks Jackson, currently serves as director of pathology at Johns MD Hopkins University School of Medicine, Baltimore. Pending approval by the university’s Board of Regents, Jackson is expected to begin work in February 2014. Current dean Aaron Friedman, MD, will fill the position until that time. James Kirkland, MD, PhD, director of the Robert and Arlene Kogod Center on Aging at the Mayo Clinic in Rochester, testified this fall before the U.S. Senate Special Committee on Aging. The points he stressed included the need to maintain a pipeline of emerging treatments. Mayo’s Center on Aging has initiated a nationwide geroscience network in collaboration with 10 other centers studying aging; the network recently received funding from the National Institute on Aging.

Keith Olson, DO, MHA, FACOFP, has been promoted within Allina Health to the post of southeast regional medical director. Olson will provide leadership within six Allina Health medical clinics. He graduated from Kirksville College of Osteopathic Medicine, Kirksville, Mo., and is board-certified in family medicine, osteopathic manipulative treatment, geriatric medicine, and clinical Keith Olson, DO densitometry. Olson was previously vice president of medical affairs at Owatonna Hospital, part of Allina Health, with clinical responsibilities within Mayo Clinic Health System–Owatonna. Peter Sandgren, MD, board-certified in internal medicine and geriatrics, has joined the general internal medicine division at Hennepin County Medical Center (HCMC) in Minneapolis. He graduated from medical school at the University of Minnesota and completed an internal medicine residency and geriatrics fellowship at HCMC.

December 2013 Minnesota Physician

interview

Improving post-acute care for an aging population  What are some examples of post-acute care?

Rahul Koranne, MD, MBA, FACP HealthEast Care System Board-certified in internal medicine and geriatrics, Rahul Koranne is vice president for HealthEast Community Services and executive medical director for Bethesda Hospital. As medical director of Bethesda Hospital, he also oversees and provides strategic direction to all inpatient and outpatient programs. Most of his work is done out in the community, working with HealthEast’s post-acute partners such as Episcopal Homes. Koranne attended medical school at the University of Delhi in India, and completed his internal medicine residency at the State University of New York in Brooklyn and his fellowship in geriatrics at the University of Minnesota. He also earned a master of business administration degree at the University of Minnesota’s Carlson School of Management.

Post-acute care includes various offerings. Number one would be a transitional care unit where patients stay about 14 days after an acute care hospitalization to receive therapy and regain their function. Number two would be skilled-nursing facilities, which used to be called nursing homes, but look and work differently now. The length of stay is shorter, with more patients and residents being able to move back into the community. Number three would be assisted-living facilities of various types, where community dwellers live on the campus and choose varying levels of services all the way from just assistance with meals to home health and high-end services.

The challenge is to think of postacute care as an integral part of the care continuum and not just the “nursing home”of old.

 What are the areas where you see the most improvement needed in communication between long-term care facilities and the physicians of those residents of the facilities? First, one of the challenges that Minnesota has taken a leadership role in is connectivity through electronic medical records. Most clinics now use electronic records, so it is easy to transfer patient information and data between hospitals and clinics. This is not yet so with transitional-care unit, long-term care, and assisted-living facilities, but it is being worked on. Second, there needs to be greater recognition that post-acute care is an increasingly integral component of how patients flow through the system. MedPAC data from 2011 indicates almost one-fourth of all Medicare spending happens in post-acute. This part of the continuum is ripe for innovation through forward-thinking partnerships.

 What steps should be taken now to deal with a population that will soon require more long-term care than our system is able to deliver?

Going directly to a nursing home for the rest of their lives is not something that a lot of our aging neighbors and community dwellers Minnesota Physician December 2013

want or necessarily need. With the whole host of post-acute care offerings now available throughout Minnesota, many patients can be served in their local communities via other options. Home health services provide nursing services or therapies in the patient’s home where they can remain with their families and neighbors. Adult day care centers are another option where elders can be dropped off in the morning and picked up later in the day. Telemedicine and other technologies allow monitoring of patients at home through either a clinic or home health services. Another recent innovation is the four-person home—what used to be called a group home in the past. The goal is to serve the right patient, at the right place, at the right time, with the right care. In addition to these nursing home alternatives, I think we also need to get better about discussing the role of palliative care and hospice with patients and families. We need to give them all of the information in a respectful way so that they understand what we are talking about, and we honor their choices and their decisions. I think a fraction of the patients who otherwise might end up in nursing homes might also choose this option if they were to understand it fully.

 How can we address the growing population of vulnerable people as their long-term care needs expand, and what type of safety net is there for these people? The dual eligible population are those who are Medicare and Medicaid eligible—the elderly with limited financial resources. Many are non-English speaking. Many are quite chronically ill, but do fine at home with support services. To address their needs, Minnesota has had a program for the last several years called Minnesota Senior Health Options (MSHO). This program partners with the whole person and their family to prevent hospitalizations and maintain them in their community without having them end up in the nursing home

if and when possible. If somebody just does not get by at home, obviously the nursing home is the right place. This particular case management has done very well.

 What are the most important things that need to change in how we finance longterm care? The challenge is for community dwellers, system leaders, employers, and government to think of post-acute care as an integral part of the care continuum and not just the “nursing home” of old. I always want to say that long-term care (nursing home care) is one piece of post-acute care. We also have transitional care units as short-stay nursing facilities, assisted-living campuses surrounding them, and home health and hospice where some of these patients can be discharged to the community.

 What can be done to improve advance care planning? The main point that sticks with me is: Who has this discussion? Where do you have this discussion? How do you have this discussion? If you are in a hospital for three days where the focus is saving your life, are you really in a good mindset to fully understand

and create a long-term plan of care and make good choices? A clinic visit has its limitations, since it can be the social event of the month for the patient. That leaves two possibilities. There are caregivers out in the community called parish nurses. They have public health nursing training, they’re integrated with the churches, and some are already trained in honoring choices or holding end-of-life discussions. The second location would be the patient’s kitchen table. This would not only work for elderly patients; it could be a younger patient struggling with a diagnosis. Either way, the patient has their loved ones by their side, and then a community health worker, parish nurse, or a home care social worker trained in the methodology of how to have this discussion meets with all of them. I often wonder if this scenario would maybe lead to a different result than some of these other venues. We need to think about where, we need to think about who, and then we need to think about hard-wiring it so that everybody in the community gets this sort of opportunity. This will help create the neighborhood that we are dreaming of, where discussion about end of life, discussion about respectful dying, discussion about

care that is necessary versus unnecessary becomes the norm instead of an oddity that everybody shies away from.

 What advice could you give other doctors that might help them to communicate with patients who will benefit from moving into an assisted-living facility but may be very committed to maintaining their independence? One of the points that I think is very important has to do with authentic engagement in the community. What I’ve learned is that teamwork is crucial. The primary care practitioner, be it a physician, nurse practitioner, or physician assistant, is an equal member of a team and leverages the strengths of others on their team. Students in all areas of health care are now being educated at the University of Minnesota from day one to understand that it is not a hierarchal system anymore. It’s really a team where whoever is in the best position to reach out to the patient and the family will do so with the eventual goal of honoring choices, respecting choices, and getting the patient to the best possible health outcome that they want. It’s not about what the team wants; it’s about what the patient wants.

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Not “part of the job” from cover

find out where you live and hurt you and your family!” Once upon a time, hospitals, clinics, and nursing homes were sacred places where people sought healing and hope. While this remains true, we are seeing a growing population of patients and visitors who act aggressively, sometimes with physical violence, toward the staff trying to help them. Violence toward staff— long considered a taboo subject and “part of the job” for health care workers—can no longer be ignored. The sanctity of our health care institutions and the safety of our workers and our patients demand that we address the issue.

Talking about the problem In the fall of 2010, when three incidents occurred on various medical units at St. Cloud Hospital, CentraCare Health recognized the issue of aggression and violence against health care workers at the hospital as a growing trend—and began to talk about it. This information

Violence toward staff— long considered a taboo subject and “part of the job” for health care workers—can no longer be ignored.

was brought forward to a nursing and patient care stakeholder group for discussion. Following the presentation, the room exploded with examples of aggression and violence

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from various nursing units, security, laboratory, and other groups. This overwhelming response on the issue led to the formation of an interdisciplinary work group that, with the help of the performance improvement department, began a Failure Mode and Effect Analysis (FMEA) process. [FMEA is

Minnesota Physician December 2013

a quality planning tool, created by management consultant D.H. Stamatis; the Institute for Healthcare Improvement describes it as “a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change.”] During its first meeting, the interdisciplinary group identified 96 failures that could cause risk to staff in the care of patients with aggressive or violent tendencies. The failures were complex and intertwined. They included: • Failure to identify patients who were at risk for committing acts of aggression and violence • Failure to intervene proactively before a violent event • Failure to communicate to staff that certain patients were at risk • Failure to provide emotional care for staff after an event occurred At this meeting, the interdisciplinary group agreed that communicating with staff on this issue couldn’t wait: Staff members needed to know that these types of incidents were no longer considered “part of

the job” and that they had to be reported. Education … and more education The health system began by educating all patient care and non-patient care staff at St. Cloud Hospital about the risks in a health care environment, how the community is changing, and what to do if faced with an aggressive situation. Patient care staff received additional training about how to recognize an escalating situation and how to intervene proactively. For example, staff were taught the acronym STAMP as a way to recognize escalating symptoms in patients: • Staring • Tone of voice • Anxiety • Mumbling • Pacing (Luck L., Jackson D., Usher K. STAMP components of observable behavior that indicate potential for patient violence in emergency departments. J Adv Nurs 2007; 59(1):11–19.) Simultaneously with the education sessions, the committee began to collect data on the number, types (e.g., verbal and physical threats), and locations of events. They also collected information on the types of staff members involved and the number of security calls. The committee found this information valuable as they studied the issue. For example, it was discovered that incidents were occurring in every unit in the hospital, in contrast to what had been perceived as a concentration of events in the mental health unit. Another discovery was that most of the staff injuries involved patient care assistants, who spend the majority of their shift in close contact with patients providing activities of daily living care. A literature search yielded three main sources that provided guidance:

Figure 1. (left) A magnet with the symbol shown below is placed outside rooms where there is the potential for violent behavior by a patient Figure 2. (center) Assaults/aggressive incidents reported per year at St. Cloud Hospital in 2011, 2012, and 2013 Figure 3. (bottom) St. Cloud Hospital code green and security assist calls for FY11, FY12, and FY13

as aggressive/violent in one CentraCare Health setting, this identifying information was not available across all system settings, such as clinic to hospital. This had to change. Now, a flag is placed in the patient’s medical record and is available to all staff across the health system. As a staff member enters the electronic medical record, an “alert” flag appears as an additional safety reminder. Another staff communication opportunity was identified for the hospital setting. When dealing with patients identified as potentially aggressive, nurses had been placing a sign on the patient’s door that stated, “Check with the nurse before entering.” After polling physicians, respiratory, laboratory and dietary staff, the committee discovered that most staff felt this sign was for patient visitors—so they would disregard the sign and enter the room. Now, a magnet is placed outside

The staff’s stories are the reason this work continues. the room of any patient indentified as a risk for aggressive/ violent behaviors (see Fig. 1). This magnet communicates the risk to those entering the room, similar to the process used to communicate to staff that certain patients are at high risk of falling. The magnet is not intended to indicate that the patient will absolutely be aggressive, but rather to show that the potential for violence is

Not “part of the job” to page 38

• The Joint Commission Sentinel Alerts on Preventing Violence in the Workplace Setting (2010) • The Occupational Safety and Health Administration (OSHA)–Guidelines for Preventing Workplace Violence • The Emergency Nurses Association Toolkit on Workplace Violence (2010) These sources, along with the information gleaned from the FMEA process, created the basis for a gap analysis, comparing actual performance with potential performance. The committee identified areas where St. Cloud Hospital was meeting best practices and opportunities for improvement, and then identified and prioritized action plans. Unfortunately, in December of 2011 and March of 2012, two significant acts of violence occurred in different areas of the hospital. The committee went back to the drawing board and began looking for a robust strategy that could be implemented

to minimize the risks our staff faced every day. The strategy they identified? Education, again. But this time, the committee asked to implement an evidence-based course on de-escalation techniques for all patient-care staff at St. Cloud Hospital. This was noted to be a significant financial cost to the organization, as the training was eight hours per employee for the first year and four hours each year thereafter. Nonetheless, the executive team wholeheartedly supported this request because of their concerns about lost staff time, increasing workers’ compensation costs, and the psychological effects of being involved in a violent or aggressive incident, as well as reputational harm to the organization. Other measures taken The committee also noted an opportunity to identify patients who were known to be at risk for aggressive behavior. Through the investigation, they had discovered that even though some patients were identified

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From the Courtroom to the Capitol.® December 2013 Minnesota Physician

Monitoring prescription drugs from cover

on prescriptions of all Schedule II–Schedule IV controlled substances; it also gathers information on certain prescriptions of federal Schedule V controlled substances (which are designated as Schedule III in Minnesota), such as codeine-containing cough syrups. Reporting is required from in-state pharmacies and other dispensers (such as prescribers and clinics), as well as from out-of-state pharmacies that ship controlled substances to Minnesota residents. Minnesota Statute §152.126 allows prescribers, pharmacists, and other specified individuals to access the information in order to better treat patients. The MN PMP was designed to be a tool that prescribers and pharmacists can use to supplement an evaluation of a patient. It is useful to identify “doctor shoppers”—patients who may

be obtaining excessive amounts of controlled substances from multiple doctors and multiple pharmacies. Additionally, it can be used to confirm a patient’s drug history or document compliance with a therapeutic regimen. However, the MN PMP does not warrant any patient profile to be accurate or complete, as it cannot guarantee that dispensers have accurately reported all controlled substance prescriptions that they have dispensed. As of Oct. 1, 2013, more than 785,000 queries of patient profiles had been requested by the 12,190 prescribers, pharmacists, and their delegates who have been granted access to the MN PMP database. Currently, the law allows prescribers to access the prescription data only when prescribing or considering prescribing a Minnesota Schedule II–Schedule IV controlled substance. The law does not allow a staff person at the MN PMP

office who notices that an individual has visited multiple prescribers and/or pharmacies in a set period of time to notify the prescribers. Instead, it is up to the prescribers to identify that a patient’s behavior suggests doctor shopping or prescription drug abuse and to consult the RxSentry MN PMP database to find out if that person is also receiving controlled substances from other sources.

Minnesota Prescription Monitoring Program Minnesota Statute §152.126 allows for the following individuals to have access to the data contained in the MN PMP database: • Prescribers and their delegates • Pharmacists and their delegates • MN Restricted Recipient Program staff (Minnesota Department of Human Services) • Minnesota medical examiners and coroners • Law enforcement (valid search warrant required) • Individuals requesting data about themselves Currently more than 10,685 Minnesota licensed prescribers and pharmacists have applied and been approved for direct access to the RxSentry MN PMP database: • 6,141 medical doctors/physician assistants/doctors of osteopathy • 417 dentists • 1,070 advanced practice registered nurses • 6 optometrists • 37 doctors of podiatric medicine • 3,014 pharmacists Resources F or further information on the MN PMP: www.pmp.pharmacy.state.mn.us F or more information about NABP PMP InterConnect: www.nabp.net/programs/pmp-inter connect/nabp-pmp-interconnect

In order to query the database, prescribers must apply in advance for authorized access. This application process, which was recently refined, requires the prescriber to access the MN PMP website (www.pmp. pharmacy.state.mn.us), select “Access Request Forms,” and then select the appropriate form. Prescribers no longer need to print the application to paper and have it notarized before submitting it. Instead, once an application is electronically submitted and passes an internal verification process, which takes about 10 minutes, the prescriber receives an email with his or her account user ID and a second email with a temporary password and instructions for accessing the RxSentry MN PMP database. Accounts do not expire, but account holders are required to update their profile information annually; failure to update will result in the account being de-

Minnesota Physician December 2013

activated. Additionally, account holder licensing information is re-verified by the MN PMP staff on a regular basis, and unsuccessful verification of credentials could also result in an account being deactivated. How to use the RxSentry MN PMP database Direct access to the RxSentry MN PMP database is free and available seven days a week, 24 hours a day via a secure web portal. To request a profile for a specific patient, the prescriber goes to the MN PMP website and selects “Login to RxSentry PMP Database” to access the secure web portal. At this point, the prescriber will need to enter his or her individual user ID and password; there are no group user accounts. When logged into the RxSentry MN PMP, the prescriber enMonitoring prescription drugs to page 30

B:8.625” T:7.75” S:7”

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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. Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is conﬁrmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly. There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and antiliraglutide 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.

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Important Safety Information

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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. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Victoza® has not been studied in combination with prandial insulin.

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Indications and Usage

Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]. INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied. CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components. WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease. All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin. Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causal-

ity could not be established. Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug. ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%). Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial Placebo + Glimepiride Rosiglitazone + All Victoza® + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2

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Constipation Dyspepsia

5.3 0.9 1.7 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 pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients. Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested 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,

VICU3X1334_ISI_Update_A_Size_Ad_BS_r6.indd 2

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*) 0 0 — Patient not able to 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) 0 — 0 Patient not able to 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. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death. OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. More detailed information is available upon request. For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015681-1 5/2013

December 2013 Minnesota Physician 5/31/13 12:48 PM

professional update: Pain medicine

he death of Minnesota Wild fan favorite Derek Boogaard in May 2011 was the tragic result of opioids and alcohol. Now his death is at the center of a possible paradigm shift in how powerful painkillers are prescribed and how misuse, overuse, and abuse are prevented. Earlier this summer, Boogaard’s family filed a lawsuit against the National Hockey League, alleging the league should have known about his doctor shopping and addiction to painkillers that he had developed as an “enforcer” in the sport. Known for the punishing hits he inflicted upon opponents, Boogaard had more career fights than goals scored. Boogaard began taking prescription painkillers in 2008 to cope with the pain from a broken tooth he suffered during one of those fights, the lawsuit alleges. Going from team doctor to doctor, he wound up receiving about 165 prescription pills

Battling the opioid epidemic A guide to advanced pain management By Rohaan Mehta, MD in a four-week period to treat pain for a broken tooth. The continued addictive behavior ultimately cost him his life. The opioid epidemic This isn’t an isolated incident. Boogaard is just one of thou-

According to a recent study

When prescribing opioids, risk assessment is the critical first step. sands who have died as the result of misuse of opioids. The expectation from patients for instant and complete pain relief and the increasing pressure on medical practitioners

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to achieve high levels of “patient satisfaction” could explain why opioids are often prescribed as the default treatment for acute and chronic pain, leading to some alarming statistics.

Minnesota Physician December 2013

conducted by the CDC in February 2013, the number of opioidrelated deaths reached a record high for the 11th straight year in 2010. In 1999 there were 4,030 opioid-related deaths in the U.S. That number went up more than four times to 16,651 in 2010. The study also reported approximately three in four pharmaceutical deaths were due to opioid analgesics such as oxycodone, hydrocodone, and methadone. The CDC also reports that nearly 500,000 people presented to the emergency room due to misuse of opioids in 2009. It is also estimated that the misuse and abuse of opioids cost U.S. insurers about $72.5 billion annually, according to a 2007 report by the Coalition Against Insurance Fraud. Some regulatory efforts are being made. In April of this year, the Food and Drug Administration barred production of any generic versions of the original OxyContin, which can be more readily abused by being crushed and snorted or injected for a quick high. In Congress, a rare bipartisan bill was introduced in March to tighten restrictions on hydrocodone because of concerns that drug fatalities have surpassed deaths from vehicle crashes. This drug

is already illegal or heavily regulated in nearly every other developed nation in the world. Germany, where the drug was first created in 1920, and the U.K. no longer use it for medical purposes. Alternatives to opioids The risks of opioid addiction and abuse tend to increase with longer-term use and escalating doses. Opioid-induced hyperalgesia can complicate long-term opioid treatment with escalating doses actually making a patient’s pain situation worse. Well-meaning and competent medical providers fall into the trap of progressively increasing opioid doses in an effort to achieve the ever-elusive “satisfactory relief” for some patients. While opioids certainly have a place in responsible pain management for select patients, in many cases opioids can be avoided with proper patient education and reassurance about painful conditions; non-opioid medications such as antiinflammatory drugs, muscle relaxants, and neuromodulatory medications; and mobilization treatments through physical therapy and chiropractic approaches. Acupuncture has been gaining greater acceptance among practitioners and patients. Practitioners must recognize and address psychological factors and addictive behavior with involvement of behavioral therapy specialists. Interventional pain management has grown as a medical specialty with formal fellowship training for physicians, and board certification to ensure competence. Interventional pain management techniques can be used to manage acute and chronic pain effectively, as well as for acute exacerbation of chronic pain conditions. For patients with intractable pain that does not respond to conservative treatments, advances in recent years have made treatment of many common pain conditions safe, accessible, and affordable when performed by formally trained interventional pain management physicians. Procedures like epidural steroid injection for radicul-

opathy are used to alleviate severe acute radicular pain and make physical rehabilitation efforts more tolerable and effective without the need to initiate powerful analgesics like opioids. They are also used to treat episodes of acute exacerbation of chronic pain, thereby avoiding escalation of opioid doses at such times.

as the Opioid Risk Tool and the Screener and Opioid Assessment for Patients with Pain (SOAPP), are available on the Internet for clinicians. Practitioners should restructure the patient’s plan for treatment with opioids in the case of problematic drug-use behavior. Strategies include:

Extensive research and advances in thermal radiofrequency ablation technology have created a safe solution for chronic pain mediated by facet joints in the neck or back from conditions like osteoarthritis or whiplash-type injuries. Radiofrequency denervation of painful facet joints can be performed reliably and safely by trained specialists, with the medical literature reporting high success rates for chronic neck and low back pain. There continues to be growing acceptance, availability, and utilization of spinal cord stimulation and peripheral nerve stimulation treatments for intractable neuropathic and persistent post-surgical pain conditions.

• Written agreement between the provider and patient (opioid agreement)

When opioids are indicated If opioids are determined to be an essential part of the treatment plan for a patient, then risk assessment is the critical first step. Patients with mental health or substance abuse disorders tend to be at increased risk for non-medical use and overdose from prescription painkillers, as well as tending to be prescribed high doses of these drugs. Patients who typically fall into the low-risk category include those who have no history of substance abuse and no major psychiatric diagnosis. A patient is likely to be at the medium-risk threshold for opioid addiction if he or she has a prior history of substance abuse or dependence, a family history of substance abuse, or a significant psychiatric issue. The high-risk category includes patients with active addictive disorders as may be determined from their medical history and urine drug screening. Tools for assessing risk of aberrant drug behavior, such

• Risk assessment

• Frequent visits and prescribing small quantities • Using long-acting drugs when appropriate and minimizing rescue doses • Monitoring use through a single pharmacy, pill counts, or avoiding replacements or early scripts • Urine toxicology screening • Coordination with a psychotherapist or addiction specialist as necessary When opioids become a problem It is important not to ignore any concerns about drug-use behavior, which should be addressed with the patient. Such behavior may include frequent requests for dose increases, failure to follow the dosing schedule, failure to adhere to recommended treatments other than opioids, unexpected results on urine drug screening, loss of prescriptions or medications, or tampering with prescriptions. Any such behavior should be followed by reassessment, a decision about whether to continue prescribing, and a restructuring of therapy if prescribing continues. With the exception of patients who suffer from painful chronic and debilitating conditions and have received a thorough evaluation and risk assessment, most other patients should have a treatment plan that ultimately culminates with weaning off of opioids. In others, problematic drug-use behaviors or progressive development of late side effects over time (such as endocrine disorders) make it necessary to wean off of opioids. There are several recommended “formulas” and approaches in the medical liter-

ature to assist providers in doing so by gradually reducing the opioid dose. Other treatments may be included to assist with pain control, such as non-opioid medications, bracing, interventional pain management procedures, physical therapy, chiropractic, acupuncture, and behavioral therapy/psychotherapy. Patients should be educated regarding potential withdrawal symptoms, and drugs like oral clonidine may be used to reduce such symptoms. Practitioner responsibility The U.S. consumes about 80 percent of the global opioid supply. Over the last decade, there has been tremendous emphasis on pain control in the U.S., possibly resulting in improvement in the lives of many patients suffering from severe intractable pain disorders. However, over the same period, prescription drug abuse has become recognized as an epidemic affecting all strata of society, from teenagers to the elderly.

Since 2003, more overdose deaths have involved opioid analgesics than heroin and cocaine combined. Increasing emphasis in the health care field on “patient satisfaction” surveys and desire for instant relief create pressure on practitioners to prescribe opioids as the default treatment for pain complaints. Practitioners have an important responsibility to individual patients, the community, and our country to carefully consider all treatment options and risks prior to prescribing opioids. Careful monitoring, consideration of non-opioid treatments, and involvement of specialists when necessary could prevent many unfortunate outcomes, like Derek Boogaard’s. Rohaan Mehta, MD, medical director of Advanced Pain Management– Mankato, is board-certified in pain medicine and in physical medicine and rehabilitation. He is a member of the American Society of Interventional Pain Physicians and the American Academy of Physical Medicine and Rehabilitation.

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December 2013 Minnesota Physician

professional update: Orthopedics

Total ankle replacement

otal hip and total knee replacements are well accepted and commonplace as valuable treatment options for end-stage arthritis. In fact, they are among the most successful and life-changing surgeries that orthopedic surgeons perform. Total ankle replacement (TAR) is not nearly as common. Very few residency programs in the United States have the ability to teach residents how to do ankle replacements, and most surgeons doing ankle replacement gain experience during their fellowship year or by attending courses specific to total ankle replacement. Ankle arthritis is somewhat less common than hip or knee arthritis and there is a perception that it does not cause as much impairment to patients. However, Glazebrook and coworkers from the Canadian study group concluded that the mental and physical disability

Improving outcomes for patients with ankle arthritis By J. Chris Coetzee, MD associated with end-stage ankle arthrosis is at least as severe as that associated with end-stage hip arthrosis (Glazebrook et

At present, five different ankle replacement systems are available in the U.S. al., J Bone Joint Surg Am 90(3), 2008). Their study and others have increased our awareness of a growing number of people suffering from ankle arthritis. Most orthopedic surgeons are comfortable doing an ankle

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fusion, and there is adequate data that fusion gives predictable pain relief. Long-term studies also have highlighted the

Minnesota Physician December 2013

concerns with an ankle fusion, however. There are specific limitations after an ankle fusion: Activity level has to be reduced, and the joints surrounding the ankle have to “take up the slack” and move more. This inevitably leads to degenerative changes in the adjacent joints. One study showed that 20 years after a fusion, the incidence of adjacent joint arthritis is 100 percent (Coester et al., J Bone Joint Surg Am 83-A(2), Feb 2001). Over the past 20 years, there has been a deliberate attempt to move the total ankle replacement experience and outcomes closer to those for hip and knee replacement. Current state of TAR surgery At present, five different ankle replacement systems are available in the U.S. Several well-designed prospective studies are looking at the results over time. The consensus is that the results do not yet mirror the results for hip and knee replacements but that significant process has been made and improvements are ongoing. Another interesting multicenter prospective study currently under way is comparing patients with ankle fusions to patients with ankle replacement over time. This should provide valuable information on how the two groups compare not only in the short term, but five,

10, or 20 years down the road. Who is a candidate for a TAR? Even though ankle replacement surgery is exciting and appears to yield satisfactory results, it is not the correct option for all ankle arthritis. Some patients will still do better with a fusion than a replacement. All artificial joints eventually wear out and need to be revised. At the moment we do not know what the longevity of a TAR will be, but projections are 10–15 years. With that in mind, my personal inclusion criteria for TAR patients are as follows: • Older than 50 • Reasonably well-aligned ankle (severe malalignment needs to be corrected before a TAR can be done) • Normal muscle function • Healthy soft tissue envelope around the ankle • Normal blood flow and nerve supply • Signs of adjacent joint arthritis are already apparent • BMI less than 35 The only time where one could bend the rules with regard to age is with patients who have rheumatoid arthritis. Patients with insulin-dependent diabetes are at a higher risk of complications, especially if they have peripheral neuropathy. What is the TAR process? TAR surgery is performed on an inpatient basis, with a hospital stay of usually a day or two. Anticoagulation is commonly used the first 10 days. Unlike total hip and knee surgeries, there is no ankle-specific rehab for the first six weeks following TAR surgery. The patient wears a short leg cast for two weeks, at which point the sutures are removed. A pneumatic boot is then used for another four weeks. During the initial six weeks, the patient can be 50 percent weight-bearing on the ankle when walking and full weight-bearing when standing.

Figure 1. A case of advanced ankle arthritis.

Figure 2. Appearance after a total ankle replacement.

(1a) Lateral and (1b) AP X-rays of a patient who suffered an ankle fracture 20 years earlier. Over time the patient developed progressive posttraumatic ankle arthritis. He tried activity and shoe modifications for several years and had several cortisone injections over time, as well as physical therapy. With time, the ankle became symptomatic enough that he opted for a TAR.

Figure 2a shows about 45 degrees plantarflexion, and 2b shows at least 20 degrees dorsiflexion six months after a successful total ankle replacement. Figure 2c shows an AP view of the same ankle. With this amount of motion, the patient is back to full normal working and recreational activity with no pain.

From three to six weeks following the surgery, active ankle range of motion is encouraged three to four times per day.

tion after an ankle replacement, whereas these aspects of gait are still abnormal after an ankle fusion.

At six weeks, X-rays are done and, if everything looks fine, the patient starts physical therapy to regain mobility, strength, and confidence. For most people, assisted devices are unnecessary by two to three months, but it may take six to nine months before the swelling or residual stiffness subsides.

What if it fails? Like any joint replacement, the ankle replacement will eventually fail. At the moment the options are to do a revision, similar to revisions for hips and knees, or to convert the revision to a fusion.

What’s to be expected post-surgery? Our practice’s studies, as well as multiple national and international studies, show the average range of motion achieved by modern ankle replacements is determined by the preoperative range of motion. In other words, good preoperative range will result in similarly good postoperative range. A very stiff ankle pre-op will improve with an ankle replacement but will not be normal. Outcomes studies show the patient satisfaction rate after an ankle replacement to be between 90 percent and 95 percent, which is comparable to other joint replacement surgeries. The major advantage of an ankle replacement over a fusion is that patients “feel normal.” Gait analyses studies show near-normal gait progression, balance, and propriocep-

With ankle replacements now gaining national acceptance, several revision replacement options are appearing on the scene. Interestingly enough, some people will elect a fusion at the time of revision. Some people say they really prefer to have a mobile ankle while they are still active and want to do outside and physical activities—so they choose a revision. Some older patients feel that the need for mobility is not that important any longer—and they choose a fusion. How common is TAR? A number of orthopedic surgeons in Minnesota are trained to do ankle replacement surgery, though it is unlikely that TAR will become as commonplace as hip or knee replacements. Patients should seek knowledge from a variety of sources, including the Internet, Web forums, and other patients.

While this might guide them in decision-making, the most important and influential factor in governing how patients decide on any particular surgical intervention is their surgeon. A high-quality doctor–patient

relationship, coupled with clear, balanced, and complete information, is essential. J. Chris Coetzee, MD, is an orthopedic foot and ankle surgeon with Minnesota Sport Medicine Institute, a division of Twin Cities Orthopedics.

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December 2013 Minnesota Physician

Special focus: Senior care

here’s no denying that changing trends are redefining health care as we know it, offering new opportunities to collaborate across medical disciplines and systems. Instead of being competitors, health care professionals can work together to achieve better care and outcomes for the people we serve. The creation of an integrated therapy services model is part of this trend. Integrated therapy services can be instrumental in achieving the Triple Aim, first articulated by Donald Berwick, MD, chief executive officer of the Institute for Healthcare Improvement. The Triple Aim is at the core of what we hope to achieve in health care today: • Improving the individual’s experience of care, including quality and satisfaction • Improving the health of our population • Reducing the per capita cost of health care

The integrated therapy model A response to changing trends in health care Kristy Brown, MS, CCC-SLP

Care integration and the Triple Aim In achieving the Triple Aim, the key is to reduce costs without sacrificing the quality of patient care. That is where an integrated system can be most helpful. Improving individuals’ experience of care can occur only when the entire care team listens to the person who is receiving care. Open discussion of what is best for the patient must include active participation by the patient. Care and treatment discussions should be guided by the patient’s desires (not our own) and should include perspectives from all

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Minnesota Physician December 2013

members of the health care team. When doctors, nurses, therapists, and other health care professionals work as an integrated team, they have access to a broad variety of services and do not have to send patients outside the system to get what they need. This approach allows professionals to provide the most efficient care and achieve better outcomes. Unfortunately, therapy has too often been perceived as separate from other aspects of treatment, leaving therapists in the dark about the objectives and decision-making process of other medical care providers. When therapists are sidelined, the quality of care suffers. For example, if a physical therapist is not consulted about a patient who is extremely weak due to illness, the wrong decision may be made about whether the patient can function well enough to return home. If a speech pathologist is not consulted when a patient’s diet is being upgraded, the chances for silent aspiration may be overlooked. This could lead to unnecessary aspiration pneumonia. On the other hand, when therapists are integrated into the total health care solution, better care and outcomes can result. An integrated therapy service model can also contribute to improving the health of populations. Increasingly, health care leaders are recognizing the importance of being proactive in developing wellness and fitness plans for clinics, hospitals, and care communities. By building participants’ strength and endurance, these plans can help residents, patients, and community members prevent future health problems. Therapists can also work

with other health care professionals to educate people to live healthier lives. For example, Centrex Rehab, a therapy company, includes a division that helps people stay in their homes longer and stay safer through home modifications, such as installing railings or widening doorways. These educational efforts are extended through community-wide projects and training programs. The more people we reach, the more we can improve the health of populations. Reducing the per capita cost of health care can be achieved in these ways through integrated models of care: • Integrated models of preventive health and wellness can result in savings by building a stronger, more independent population through collaborative efforts. • Offering health education and home modifications can help people live in their homes longer, improving the quality of their lives at less cost to the community. We also must continue to challenge ourselves to redefine care. For example, an integrated model that maintains consistent outcomes and adopts a creative approach to who provides treatment, how it is delivered, and the duration of intense treatment can yield substantial savings to practitioners. Integration is crucial to quality outcomes Moving toward more interactive, coordinated models of care means connecting care communities with clinics, therapy centers, house calls, and care networks such as accountable care organizations. This model helps not only individuals who receive care, but providers as well. Providers are well aware that under new federal rules for Medicare/ Medicaid, hospital readmissions can result in financial penalties. When therapists and physicians are part of the same integrated system, rehospitalizations are much more preventable and physicians can be confident

that the organization’s service level, care, and focus are working. Integrated systems can also make for smoother billing, payments, and reimbursements, as care is coordinated through cooperating partners with the same objective. Similarly, in this era of increased regulations and compliance requirements, health care services that are part of an integrated system will view compliance and regulatory requirements as of the utmost importance. A new approach to health for older adults Every part of the Triple Aim is relevant to older generations. Census figures show that the fastest-growing age group in the U.S. consists of people aged 75 and older. By 2030, this group will number 33 million people—9 percent of our population—and the number of Minnesotans aged 85 and older will increase by 50 percent. Older adults have unique needs and often have multiple medical conditions. Therefore, it is highly advantageous for them to have access to an integrated therapy service model with a range of options so they do not have to use multiple treatment providers. In addition, integrating therapy services with medical care allows the entire health care team to discuss medications and conditions to be sure all the pieces of a care plan fit together. Centrex Rehab has developed an integrative approach to providing care. A physical therapist works with local hospitals to provide pre-operative education to individuals going through joint replacement surgery. Meeting a therapist before surgery enables patients who are admitted to transitional care settings after surgery to become more comfortable with their therapists. When patients return home, the company subcontracts with a home care provider to allow for a smooth transition. Physicians say they appreciate the steady stream of communication, all from the same therapist. Patients are also much more comfortable going

through two transitional periods knowing the same therapist

team that helps get the patient back home—feel a strong sense

When therapists are integrated into the total health care solution, better care and outcomes can result. will be providing their care. This is especially important for older patients who tend to be more anxious about abrupt changes, as anxiety can disrupt recovery. Advantages of integrated systems for physicians include better communication and coordination, supporting better outcomes. As new models of care emerge, outcome-based mechanisms for compensation are sure to be used. We now have before us the opportunity to see whether integrated systems will offer better results than traditional “siloed” care-delivery systems. Integrated care: an example One example of the integrated system at Centrex Rehab involves its work in assisting Twin Cities Orthopedics’ Excel program at York Gardens in Edina. The premise for this program is that when a healthy person needs a joint replacement, a physical therapist sees the patient to develop a pre-surgery fitness plan several weeks or months before the surgery. On the day of surgery, the patient arrives with added strength and a high level of physical fitness that reduces problems after surgery. The procedure is completed at Twin Cities Orthopedics and after recovering for a few hours, the patient is transported with a nurse and medication to York Gardens. Upon arrival, the patient is met by a physical therapist who provides treatment; the patient is up and walking by that afternoon or early evening. The next day, after two more sessions with a physical therapist and one with an occupational therapist, most patients are able to return home that evening. All the health care staff involved in this program—from those who participate in the pre-surgery consultation to the

of accomplishment and success. Patients tell us they feel strongly supported and appreciate the care they receive. The program has been so successful that Twin Cities Orthopedics plans to expand it to other locations in the metro area. Laying the groundwork While integrated models are likely to play out differently in different situations, the core objective remains the same: achieving the Triple Aim. As organizations build partnerships, they will have new tools that enable them to improve the experience of care. Coordinating a system around all aspects of the Triple Aim has resulted in great success at Centrex Rehab

and other companies that use integrated care models. What does “success” look like for us with these models? • P re-surgery strengthening protocols • State-of-the-art surgery techniques • Strict adherence to pain medication guidelines and intense therapy Of course, the success of any model depends on excellent communication among an interdisciplinary team of professionals. As we continue moving toward a new integrated model of care, we are laying the groundwork to achieve the Triple Aim in Minnesota while serving as a model to other systems nationwide. A new, cooperative approach to care is the key to a brighter future for health care delivery. Kristy Brown, MS, CCC-SLP, is the president and CEO of Centrex Rehab in Minneapolis.

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December 2013 Minnesota Physician

Special focus: Senior care

he phenomenon in the United States that is sometimes called the “silver tsunami” reflects the aging of the baby boom generation, comprising 78 million Americans born between 1946 and 1964. To put this in perspective: One of every 10 Americans is now 60 years or older; that ratio will grow to one in five by 2050, and to one in three by 2150. As health care providers and design professionals for the senior housing industry plan for the future, the rules of the past may not apply to this new generation of seniors. Society is experiencing a generational shift in the needs and desires of our aging population. The attitudes of baby boomers toward retirement and “aging in place” are evolving, and separate senior housing categories such as “independent living” and “assisted living” are beginning to converge. Nursing homes and assisted living facilities are expanding to

Architecture for aging Evolving design reflects evolving attitudes By John W. Gould, AIA

encompass the varied needs and desires of seniors in an effort to attract and keep residents. At the same time, advances in technology are enabling seniors to stay in their homes longer and have taken hold in the home health care industry. Against this backdrop, the concerns of health care providers and senior living providers are moving closer and closer together. For a variety of social, political, and economic reasons, we are seeing the formation of strategic alliances between these two “provider” groups. In 2004, the American Institute of Architects (AIA)

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Minnesota Physician December 2013

established the Design for Aging Knowledge Community to more effectively represent professionals who design for aging populations and to provide a forum to share common challenges, opportunities, and passion for design for seniors. As an invited member of the advisory group, I have been fortunate to associate with national leaders who have access to developments in the industry. This article summarizes key aspects of architecture for aging and discusses several current research and evidence-based design trends aimed at providing environments that allow seniors to maintain spiritual, social, physical, and emotional well-being. The “small house” concept The senior living market has evolved dramatically since 1985. Often referred to as the continuum of care, it generally consists of independent living apartments, assisted living, memory care, and skilled nursing/transitional care. Each level of housing and care can be built as a single-site development, but often all or several of the living/ care components are masterplanned as part of a larger Continuing Care Retirement Community (CCRC). Environments for aging populations have consistently and continually evolved from an institutional model to a residential model. Designers strive to create supportive, wellness-oriented environments that promote the optimal functioning of all the individuals who live there. Buildings and spaces are designed to be home-like and residential in character. One example of this evolving design philosophy is the small-house, person-centered care concept, often referred to

as the “Green House” model. It was conceived as a direct challenge to the traditional view of long-term care. In a Green House environment, residents receive nursing support and clinical care, but the residents’ quality of life is vastly improved through smaller facility size, efficient staffing patterns, and design. These lifestyle benefits have resulted in higher satisfaction, a slowing of physical decline, and decreased depression. A Green House is designed to look and feel like a private home. Generally there are between seven and 10 bedrooms, and all residents have their own private room. Common living areas consist of a shared living room, dining room, and kitchen. Residents, caregivers, and residents’ family and friends assist in meal preparation, dine together, and interact socially (both informally and through formal programming). The home is supported by a team that may include a medical director, nurses, social workers, activities experts, therapists, nutritionists, and pharmacist(s). The Green House concept was conceived by geriatrician William H. Thomas, MD, in 2003. In 2005, the Robert Wood Johnson Foundation announced a five-year, $10 million grant for a nationwide Green House Project. NCB Capital Impact currently administers the project and will continue to do so. More than 260 Green House homes in 32 states are open or in development. Dementia/Alzheimer’s care Though it’s sad to report, the biggest “growth industry” in senior care has become dementia disease management. The number of seniors with cognitive impairments is fueling the increased need for memory care programming and facilities. The number of Americans aged 65 and older diagnosed with Alzheimer’s disease was 5.1 million in 2010 and is projected to rise to 13.5 million by 2050, according to estimates from the Alzheimer’s Association. More than 15 percent of the 65+ population will receive an Alzhei-

not isolated in their rooms. It is extremely important to incorporate innovative approaches to

communicate with wireless sensors in the residence in order to provide telehealth services,

As our understanding of cognitive impairment increases, so will appropriate evidence-based design responses. creating purposeful activities areas that stimulate memory and the five senses. As our understanding of cognitive impairment increases, so will appropriate evidence-based design responses. Assistive technology The economic and real estate downturn of 2008 affected the senior living market dramatically. As home prices fell, seniors were more cautious and hesitant to sell their family homes to move to a senior community. The industry shifted from a choice-based to a needsbased market. Independent living development slowed, and was replaced by a focus on the higher acuity senior environments. A combination of the economy and the demands and preferences of the aging boomers has reinforced their desire to stay at home and age in place. Assistive technology devices are rapidly emerging in the marketplace and, for many seniors, make the difference between being able to live independently and having to move to a care environment. A 1993 study by the National Council on Disability estimated that 80 percent of elderly people who used assistive technology were able to reduce their dependence on others. Assistive devices enhance the quality of life by making activities of daily living manageable without the need for home health care. Adaptive switches, communication equipment, computer access, home modifications, mobility aids, seating aids, and sensory enhancements have long been accessible to seniors. Newer technology is constantly emerging. Systems to manage health, environment, and activity are now Internet-connected and

caregiver alerts, urgent call communication, and medication management. Residents’ heart rate, body temperature, and blood pressure can be monitored remotely. Many systems are GPS-enabled to identify the location of the resident, detect falls, and notify caregivers if the resident cannot get out of bed. It will not be long before robots will assist and enhance the lives of seniors in their homes (remember the 1973 Woody Allen movie “Sleeper”?). Six European universities are currently building robots, which, among other kinds of assistance, will pick up objects in the home that seniors may trip over. One such

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mer’s diagnosis within the next 40 years. The current supply of memory care-specific environments will be insufficient to meet the needs of residents with cognitive impairment. Historically, memory care has been a secured special care unit within the traditional skilled nursing facility. Now, as part of the evolving industrywide desire to create more home-like environments where residents can age in place, we are seeing the emergence of stand-alone memory care residences. As design professionals adopt an evidence-based design approach and more clearly recognize the relationship between the built environment and resident outcomes, the state-of-theart memory care environments help residents remain independent and enable staff to deliver care more effectively. The small house concept is well suited to the design of memory care facilities. For example, residents’ agitation, confusion, and feelings of isolation are mitigated by the scale of the building and smaller number of residents. Special attention is given to providing adequate daylighting, reducing glare, creating an appropriate acoustical environment, and using color and texture appropriately. Additionally, the smaller scale of the environment encourages socialization and increases the residents’ ability to use and enjoy the space. Open floor plans are designed to allow flexible circulation and to allow for wandering or confused residents to easily and safely find a path back to familiar spaces. The plans avoid deadend hallways or locked doors, as they can create frustration and agitation, resulting in unwanted behaviors and increased stress to the caregiving staff. Although successful memory care environments have been developed in multi-story buildings, a one-story building is desirable. Unrestricted access to secure outdoor spaces allows safe wandering paths and opportunities for therapeutic gardening activities. The plan should encourage residents to be out in the common areas and

robot being developed is Hobbit the Robot. A robotics research project funded by the European Union and coordinated at the Vienna University of Technology is studying a robot that will make seniors feel safe at home. In addition to picking up objects, the robot will be able to recognize objects, bring objects to seniors, and be equipped with entertainment functions. An integrated approach The future promise of design for aging populations is that it continues to diversify and explore more social, less institutional models of programming and built environments. Trends in senior living are integrating medical support into a broad spectrum of healthy everyday tasks and activities. John W. Gould, AIA, is senior living design leader for DLR Group, Minneapolis, and is a member of the AIA Design for Aging Advisory Group.

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December 2013 Minnesota Physician

Urology

rinary incontinence isnâ&#x20AC;&#x2122;t new. Women have been plagued by both urge and stress incontinence for years. In fact, between 30 percent and 50 percent of women experience some leakage after childbirth. Today, however, there are new diagnostic techniques, new medications, and new treatment options that make an old problem more manageable. Urinary incontinence is either stress incontinence (sphincteric dysfunction), urge incontinence (bladder dysfunction), or a combination of the two. Assuming there is no underlying bladder infection, family medicine physicians usually refer a patient to a specialist for further diagnosis and treatment. This can be a urologist, but many times the problem is gynecologic in nature, necessitating an ob-gyn specialist. Diagnostic techniques Several diagnostic techniques can help determine the cause and severity of urinary incontinence.

Urinary incontinence New diagnostic and treatment options By Ron Mjanger, MD

Postvoid residual (PVR) measurement. For this proce-

cian tests for loss of urine.

dure, women urinate into a container to measure output, after which the physician checks the quantity of residual urine using a catheter or ultrasound test. A significant quantity of leftover urine in the bladder might signal an obstruction in the urinary tract or a problem with bladder nerves or muscles.

newer test, the bladder is filled with water as a monitor measures bladder strength and urinary sphincter health, as well as the pressure at rest and when filling. Urodynamic testing can help a physician distinguish the type of incontinence experienced by the patient.

Pelvic ultrasound. Physicians also may use an ultrasound to check for abnormalities in other parts of the urinary tract or pelvic region.

Stress test. For this test, a woman is asked to cough vigorously or bear down as the physi-

Urodynamic testing. In this

Cystogram. This X-ray of the bladder is taken as a patient urinates a fluid containing a special dye, helping to identify problems in the urinary tract. Cystoscopy. Using a cystoscope inserted into the urethra, a physician can see and remove certain abnormalities in the urinary tract. Medications

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Minnesota Physician December 2013

al women are prone to bladder infections because of their low estrogen levels. The vagina of a younger woman has a certain pH level caused by good lactobacillus that live there. When estrogen levels decrease, these bacillus quantities decline, causing the pH level in the vagina to rise, and harmful bacteria to increase. Low-dose topical estrogen in the form of creams, rings, or patches, can be helpful. Women with a history of cancer are understandably nervous about introducing estrogen into their system, but there is very little danger in vaginal estrogen creams because so little is absorbed into the bloodstream.

Anticholinergics. Several medications have been approved to calm an overactive bladder. They include oxybutynin (Ditropan, Oxytrol, Gelnique), tolterodine (Detrol), solifenacin (Vesicare), fesoterodine fumarate (Toviaz), trospium (Sanctura), and darifenacin (Enablex). Side effects may include dry mouth, blurred vision, constipation, and urinary retention.

Antidepressants. Sometimes antidepressants improve incontinence. Imipramine (Tofranil) is a tricyclic antidepressant used to treat a combination of urge and stress incontinence. Duloxetine (Cymbalta) sometimes is used to treat stress incontinence. Bulking material injections. Bulking agents, such as carbon-coated zirconium beads (Durasphere), calcium hydroxylapatite (Coaptite), polydimethylsiloxane (Macroplastique), and collagen, can be injected into tissue around the urethra. This five-minute office procedure can help keep the urethra closed and reduce urine leakage. Repeat injections, however, are usually needed.

Botox injections. While botox injections are not yet approved by the U.S. Food and Drug Administration for incontinence, some research physicians have used botulinum toxin type A (Botox), the same substance dermatologists use on facial muscles, to relax an overactive bladder. The substance is injected into the bladder muscle with a needle inserted via a cystoscope that goes up into the bladder. Effects last about nine months and may require self-catheterization to empty the bladder. Treatment options When medications donâ&#x20AC;&#x2122;t work and first-line treatment options, such as Kegel exercises, physical therapy, and biofeedback donâ&#x20AC;&#x2122;t provide satisfactory results, physicians consider other options, starting with the least invasive.

Pessary. A pessary, a stiff ring worn in the vagina, helps to hold up a prolapsed bladder or uterus and prevent urine leakage. Slings. Much has been written recently about mid-urethral sling procedures, in which synthetic materials or mesh are used to create a hammock around the bladder neck and urethra. The sling was designed to keep the urethra closed, especially when a woman coughs or sneezes. Sometimes mesh is used to hold up the vagina in an attempt to reduce incontinence. For many women, this mesh offered a good solution, but others experienced

significant scarring and pain, necessitating mesh removal and surgery to reconstruct the anatomy. Recently, the U.S. government issued warnings about the use of certain transvaginal nylon mesh used in the treatment of urinary incontinence. As a physician who has performed a large number of these vaginal mesh removals, I can attest to the fact that the removal can be tricky. I have found that using the da Vinci Surgical System for mesh removal and reconstructive surgery has changed the process considerably. In the past, the mesh was inserted vaginally. Every time a physician operates through the vagina, however, he or she needs a seam allowance, and the vagina gets smaller. Eventually, it becomes too small for intercourse. With the da Vinci, we can now perform sacrocolpopexy laparoscopically. Using the da Vinci, I can go through a woman’s naval, with a camera, and get down behind the vagina without cutting into it. There is no further vaginal shrinkage, making it a

VErDi

nice option to offer women. This procedure, combined with newer, smaller pieces of mesh, has become the stateof-the-art repair for vaginal

that control bladder function. Physicians report improvement within the first couple of weeks. With this option, however, a patient will require a series of

bladder. Physicians open the bladder through an incision in the abdomen and attach a strip of tissue, usually from the intestine or stomach, to the bladder opening, thus enlarging it. Recovery may take up to six weeks, and lifelong use of a catheter to empty the bladder may be necessary.

Urinary incontinence has come out of the closet, with more women talking to their physicians about the problems of urge and stress incontinence. prolapse. Minimally invasive surgeries result in faster recovery, along with less pain, bleeding and scarring.

Electrical stimulation. While not yet a mainstream treatment, electrical stimulation is becoming more prevalent in the treatment of urinary incontinence. Percutaneous tibial nerve stimulation (PTNS), for example, is a procedure that can be conducted in a physician’s office. Following the insertion of a tiny needle electrode into the tibial nerve just above the ankle, the physician generates a mild electrical impulse to nerves of the spine

MAC BE TH

approximately 12 treatments over 12 weeks. Another option is stimulation of the sacral nerve, in which mild electrical impulses are sent to the sacral nerve near the lower back. A device similar to a pacemaker is surgically implanted under the skin in the upper buttocks, providing electrical pulses that influence bladder function. The procedure to implant the device is minimally invasive and reversible.

Bladder augmentation. Bladder augmentation is a major, complex surgical procedure used to increase the size of a woman’s

More women seeking treatment Urinary incontinence has come out of the closet, with more women talking to their physicians about the problems of urge and stress incontinence. As a result, more women are seeking help and receiving relief from the problem.

Ron Mjanger, MD, Metro OBGYN, practices at several locations, including the Apple Valley Medical Center. He has performed more than 10,000 pelvic surgeries and more than 700 da Vinci procedures. Mjanger was the first regional surgeon to perform da Vinci prolapse procedures, and currently teaches new procedures to other physicians.

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December 2013 Minnesota Physician

O r a l H e a lth

Dentistry and medicine

entistry today is far different from what was practiced only a decade or two ago, not only in techniques and procedures, but also in types of patients seen. As a result of advances in medical science, pharmacotherapeutics and health care, public health measures, and environmental conditions, people are living longer and receiving medical treatment for disorders that were fatal only a few years ago. While the practicing dentist always has had an appreciation for the importance of oral health, research reports and articles in the lay press during the past 25 years have done much to bring this to the attention of our medical colleagues and the public at large. In particular, the possibility that events in the oral cavity can influence systemic disease has been highlighted by the U.S. Surgeon General’s report in 2000 and in numerous reports of investigations into associations

The relationship between oral and systemic health By Nelson L. Rhodus, DMD, MPH, FICD

and interactions between oral disease—particularly periodontal disease—and coronary heart disease, stroke, adverse pregnancy outcomes, diabetes, and bacterial pneumonia.

them appropriately. Likewise, physicians must be equally aware of patients’ oral health and status and the impact it can have on patients’ overall systemic health.

Further, because of the increasing numbers of dental patients—especially the elderly, who are fortunately retaining their natural teeth into advancing age but also present with chronic medical problems—dentists must remain knowledgeable about patients’ medical conditions and manage

Many chronic disorders or their treatments may manifest in the oral cavity (i.e., leukemia and other hematological disorders, cancer, gastrointestinal disorders, HIV, and other infectious diseases). These conditions necessitate recognition, diagnosis, and early referral, as well as alterations in the provision of dental treatment. Often, communication between dentist and physician is imperative to ensure safe and proper care. Failure to make appropriate treatment modifications can result in serious consequences, including death of the patient. Since the number of dental patients with medically compromising conditions is increasing and poses a significant challenge for dental management, several concerns must be addressed: • The effect of the patient’s medical condition and therapy (particularly pharmacotherapy) on oral health and the delivery of dental treatment • Specific oral and dental manifestations that arise or are exacerbated by the medical condition and/or therapy for it • Possible adverse interactions between the patient’s oral health and general systemic health The key to successful dental management of a medically compromised patient requires a thorough evaluation and

Minnesota Physician December 2013

assessment of risk to determine whether a patient can safely tolerate a planned procedure. Risk assessment involves the determination of at least three components: (1) the nature, severity, treatment, and stability of the patient’s medical condition; (2) the physical, immunological, and emotional state of the patient; and (3) the type and magnitude of the planned procedure (invasive or noninvasive). All factors must be carefully weighed for each individual patient. For example, a patient may have severe congestive heart failure, but the risk is minimal if the planned procedure is limited to taking radiographs (noninvasive) and the patient is not anxious or fearful. Conversely, the risk may be significant if the congestive failure is only moderate, but the procedure planned is a full-mouth extraction (invasive) and the patient is very anxious. Therefore, the dentist must carefully weigh the physical and emotional state of the patient against the invasiveness and trauma of the planned procedure. The cornerstone of patient evaluation and risk assessment is the medical history, supplemented by physical examination; laboratory tests; and, very often, a medical consultation with the patient’s physician is appropriate. The discussion below focuses on common medical conditions affecting dental treatment. Cardiovascular disease Any patient with cardiovascular disease (heart failure, heart attack, angina, arrhythmias, hypertension, heart murmurs, stroke) presents a potential risk for undergoing dental treatment. For example, a history of a myocardial infarction within the recent past may preclude elective dental care because during the immediate postinfarction period, patients have increased susceptibility to repeat infarctions, arrhythmias, and heart failure. Patients with untreated or poorly controlled congestive heart failure, hyper-

tension, or cardiac arrhythmias generally should not receive elective dental treatment.

healthy women to have a preterm infant.

Vasoconstrictors should be used cautiously in patients taking digitalis glycosides (digoxin) because the combination can precipitate arrhythmias. Stress, anxiety, physical activity, drugs, and hypoxia are some elements that can precipitate arrhythmias. Cautious use of vasoconstrictors in local anesthetic is also recommended in patients prone to angina or arrhythmias.

Diabetes There is evidence for a relationship between periodontal disease and type 2 diabetes. Diabetes, particularly long-standing or poorly controlled disease, is a risk factor for periodontal disease. There is some evidence that periodontal disease may increase one’s risk for developing

Dental treatment can increase blood pressure. Patients with hypertension (>140/90 mm Hg) should be identified prior to dental treatment. Patients with severe hypertension (>180/110 mm Hg) should not receive elective dental treatment until the blood pressure is brought under control. Some antihypertensive medications, such as some beta-blocking agents, may require special consideration during dental treatment. Here again, vasoconstrictors should be used cautiously. The presence of a heart murmur may be of special significance in dental patients. If a murmur is caused by a pathologic condition, the patient may be susceptible to an infection inside the heart (on or near the heart valves) as a result of microorganisms entering the bloodstream from dental treatment that caused significant bleeding. This infection, called infective or bacterial endocarditis, is a serious problem that can be fatal. A patient identified as having a heart murmur of pathologic or unknown origin may need to be placed on antibiotics prophylactically for certain dental procedures in an attempt to prevent bacterial endocarditis. Currently, oral amoxicillin is the drug of choice for this purpose. Pre-term birth The association between a woman’s periodontal health and her risk for a poor pregnancy outcome is consistent and fairly modest. Overall, studies suggest that women with periodontitis are about two to three times more likely than periodontally

data for decision-making are lacking. Recommendations to place dental patients on prophylactic antibiotics have been made empirically by orthopedic surgeons, but little evidence suggests that dentally induced bacteremia may cause PJI. Although reports in the literature weakly associate PJI with dentally induced bacteremia, authors have questioned the validity of these reports. It appears that wound contamination or skin infection is the source of the vast majority of infections. Even the few cases of PJI presumably caused by oral bacteria appear more likely to have resulted from physiologically occurring bacteremia or bacteremia caused by acute or chronic

Many chronic disorders or their treatments may manifest in the oral cavity. diabetes and that periodontal treatment may improve glycemic control in patients with type 2 diabetes. Patients with diabetes mellitus need to be identified in terms of type of diabetes and control measure. Those with type 1 diabetes have more severe disease with more complications and are of greater concern for management than are those with type 2 diabetes. Patients with type 1 diabetes require insulin for controlling their disease, whereas people with type 2 diabetes often do not. However, more people with type 2 diabetes are now treated with insulin than in the past. Those taking insulin are potentially prone to hypoglycemia in the dental office if they skip normal meals. Patients with diabetes typically do not handle infections very well and also may have exaggerated periodontal disease. Artificial joints When treating patients with prosthetic joints (most commonly, hip and knee, followed by shoulder, elbow, wrist, and ankle), a question for dentists arises concerning the need for antibiotic prophylaxis to prevent infection of the prosthesis. This is a legitimate concern; however, the primary issue is whether bacteremia resulting from dental procedures can cause prosthetic joint infection (PJI). This issue has been debated for many years, although scientific

infection than from invasive dental procedures. Salivary gland dysfunction and hyposalivation Saliva in normal quantity and composition is rich in constituents that have potent antimicrobial, antacid, lubricative, and homeostatic properties. Saliva contains approximately 60 important protective constituents, including immunoglobulins, electrolytes, buffers, antimicrobial enzymes, and digestive enzymes, all of which make saliva an essential contributor to the health and homeostasis of the oral cavity. When saliva is diminished in quantity or altered in composition, as in Sjögren’s syndrome (SS), deterioration of oral soft and mineralized tissues may occur. The most common causes of hyposalivation are medications (more than 1,400 drugs are associated with hyposalivation), irradiation or chemother-

Dentistry and medicine to page 28

Psychiatrist Cross-Cultural Medicine HealthPartners Medical Group in St. Paul, Minnesota, seeks a BC/BE licensed psychiatrist to practice cross-cultural medicine with our experienced Behavioral Health team at the Center for International Health (CIH), an internationally recognized refugee/immigrant medicine clinic which has helped define best practices in refugee and immigrant healthcare for 30+ years. U.S. and international experience providing psychiatric care to refugees and globally mobile populations is strongly preferred. Qualified bilingual psychiatrists (especially those fluent in Somali, Khmer, Oromo, Karen, Vietnamese, Hmong, Nepali or Russian) are encouraged to apply. This part-time (0.5 FTE) position will provide outpatient psychiatric care closely integrated with primary care in a holistic care model, while partnering with community organizations and the MN Department of Health’s Refugee Health Program. There is also opportunity for an academic faculty appointment at the University of MN and teaching involvement in the Global Health Pathway (www.globalhealth.umn.edu). HealthPartners offers a rewarding practice with a competitive salary and benefits package. Forward your CV and cover letter, specifying your language fluency and global health/refugee medicine experience, to lori.m.fake@healthpartners.com or apply online at healthpartners.com/ careers. For more details, call 800-472-4695 x1. EOE

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December 2013 Minnesota Physician

Dentistry and medicine from page 27

apy for cancer, and autoimmune disease such as SS. Bisphosphonate-associated osteonecrosis (BON) In the past decade, a potentially serious oral complication of cancer treatment was identified: bisphosphonate-associated osteonecrosis of the jaw (BONJ). Bisphosphonates are used to treat osteoporosis, Paget’s disease of bone, multiple myeloma, and hypercalcemia of malignancy. Though BON can occur, rarely, with the oral administration of bisphosphonates, it is a much more common complication of injected bisphosphonates. The exact mechanism that leads to BON is unknown. However, risk factors have been recognized and may be classified as systemic and local. In addition to injected bisphosphonates, risk factors include diabetes mellitus, overall cancer stage and tumor burden, overall

systemic and immune health, immunosuppressive drug use, any periodontal or other oral infection, and a history of radiation to the jaws. Posterior sites are at higher risk than anterior sites, and the mandible is more often affected than the maxilla.

Chemoprevention methods for oral cancer are currently being explored. Oral cancer Oral cancer includes a variety of malignant neoplasms that occur within the mouth. More than 90 percent of cases are attributed to squamous cell carcinoma (SCC). About 9 percent are carcinomas that arise from salivary gland tissues and other tissue types, such as sarcomas and lymphomas. The remaining 1 percent are metastatic from elsewhere in the body, most commonly from lung, breast, prostate, and kidney. At least

80 percent of cases are associated with the multiple cellular abnormalities resulting from chronic and excessive exposure to carcinogens found in smoking tobacco, and alcohol, smokeless tobacco, and betel leaf that contains areca nut. HPV-associated oropharyngeal cancer now accounts for about 20 percent of all new cases. Oral SCC has a variable appearance. It may be a white or red patch, an exophytic mass, an ulceration, a granular raised lesion, or combinations of these. White lesions that cannot be scraped off and are clinically nonspecific, called leukoplakia, are potential precursor lesions. Obviously, earlier detection of oral SCC implies improved outcomes. Investigators (including the author) are researching genomic and proteomic methods to identify biomarkers in oral fluids that may reveal specific diagnostic or prognostic utility, which will aid in earlier detection and progression.

Most early oral SCCs are amenable to surgery, whereas stage III or stage IV cancers (and those involving bone, vascular structures, and multiple lymph nodes), as well as hypopharyngeal SCCs, are usually treated with radiation or combination therapy (irradiation and surgery). Radiation is administered by interstitial, implantation, or, more commonly, external beam methods, usually within six weeks of surgical resection. Chemoprevention methods are also currently being explored (by the author and his team at the University of Minnesota) to prevent the carcinogenic transformation of premalignant oral lesions such as leukoplakia. Nelson L. Rhodus, DMD, MPH, FICD,

is a diplomate of the American Board of Oral Medicine; a professor and the director of oral medicine at the University of Minnesota School of Dentistry; and an adjunct professor of otolaryngology in the U of M Medical School, Minneapolis.

Physician Practice Opportunities Avera Marshall Regional Medical Center is part of the Avera system of care. Avera encompasses 300 locations in 97 communities in a five-state region. The Avera brand represents system strength and local presence, compassionate care and a Christian mission, clinical excellence, technological sophistication, an array of specialty care and industry leadership. Currently we are seeking to add the following specialists: • General Surgery

• Obstetrics/Gynecology

• Radiology/Oncology

• Family Practice

• Internal Medicine

• Ophthalmology

• Pediatrics For details on these practice opportunities go to http://www.avera.org/marshall/physicians/ For more information, contact Dave Dertien, Physician Recruiter, at 605-322-7691 • Dave.Dertien@avera.org

Avera Marshall Regional • Medical Center 300 S. Bruce St. • Marshall, MN 56258

www.averamarshall.org 28

Minnesota Physician December 2013

Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community

An immediate opportunity is available for a BC/BE orthopedic surgeon in Bemidji, MN. Join three board certified orthopedic surgeons in this beautiful lakes community. Enjoy practicing in a new Orthopedic & Sport Medicine Center, opening spring 2013 and serving a region of 100,000. Live and work in a community that offers exceptional schools, a state university with NCAA Division I hockey and community symphony and orchestra. With over 500 miles of trails and 400 surrounding lakes, this active community was ranked a “Top Town” by Outdoor Life Magazine. Enjoy a fulfilling lifestyle and rewarding career. To learn more about this excellent practice opportunity contact: Celia Beck, Physician Recruiter Phone: (218) 333-5056 Fax: (218) 333-5360 Email: Celia.Beck@sanfordhealth.org AA/EOE - Not subject to H1B Caps

Think about what you really want in a career. We’ve got you covered from both sides...

The Left Side

The Right Side

Your Analytical, Pragmatic Side

Your Creative, Spontaneous Side

*Company Paid Malpractice Insurance *Comprehensive Healthcare Benefits + 401(k) Plan *Consistent & Predictable Work Schedule *Freedom from the Hassles of Managed Care; No Insurance or Billing Issues

*Generous Paid Time Off & Holidays *Professional Satisfaction Treating Diverse & Clinically Interesting Cases *Collaborate with an Experienced Treatment Team of Healthcare Professionals and Security Staff *CME Paid Days Off & Reimbursement

MHM Services, in conjuction with Centurion of Minnesota is proud to be the provider of healthcare services to the Minnesota Department of Corrections. We currently have excellent Full Time, Part Time & Per Diem PRIMARY CARE and PSYCHIATRIST opportunities available throughout Minnesota, including the following locations: Lino Lakes * Shakopee * Oak Park Heights * Stillwater Faribault * Moose Lake * Red Wing * Rush City * St. Cloud We are also seeking a Primary Care Physician to serve as our STATEWIDE MEDICAL DIRECTOR based out of our Regional Office in St. Paul. For more information, please contact: Tracy Glynn· 877.616.9675· tracy@mhmcareers.com

www.mhm-services.com | Equal Opportunity Employer December 2013 Minnesota Physician

Monitoring prescription drugs from page 12

ters, at minimum, the patient’s name (full or partial) and date of birth. It is highly recommended that prescribers enter only the first three letters of the patient’s first name, the first three letters of the patient’s last name, and the patient’s date of birth, in order to return a more complete list of potential patient name matches. The prescriber then selects all the appropriate patients from the list and requests a query of the database. Each query report, by default, contains prescriptions that have been reported to the MN PMP for the past 12 months. Results are returned to the screen within seconds, and the prescriber can make a paper copy of the query report by selecting the appropriate option once the initial information has been returned to the computer screen. First-time RxSentry MN PMP database users are encouraged to view the “RxSentry

Query and Reports Tutorial” on the website before submitting their first query. The patient profile reports from database queries are private, and whether they are stored electronically or in print, they must be given the same security considerations as other protected health information.

Minnesota’s Prescription Monitoring Program staff have been working with others on a process for exchanging PMP data across state lines. Information about an individual cannot be accessed unless the prescriber is currently treating that individual and is prescribing/considering prescribing or dispensing/considering dispensing a controlled substance medication for him or her. If a prescriber’s query identifies a patient who the prescriber believes is abusing or misusing controlled substances, it is

Family Medicine St. Cloud/Sartell, MN We are actively recruiting exceptional full-time BE/BC Family Medicine physicians to join our primary care team at the HealthPartners Central Minnesota Clinics - Sartell. This is an out-patient clinical position. Previous electronic medical record experience is helpful, but not required. We use the Epic medical record system in all of our clinics and admitting hospitals. Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Several of our specialty services are also available onsite. Our Sartell clinic is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with traditional appeal. HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. We offer a competitive compensation and beneﬁt package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.jobs or contact diane.m.collins@healthpartners.com. Call Diane at 952-883-5453; toll-free: 800-472-4695 x3. EOE

30 Minnesota Physician MN Physician 4" x 5.25" 4-color

suggested that the prescriber work with the patient to find alternatives to the current regimen and possibly refer the patient to substance abuse treatment if deemed necessary. If a prescriber’s query identifies a patient who the prescriber believes is doctor shopping and/ or diverting controlled substances, it is suggested that the

December 2013

prescriber work with local law enforcement to determine the appropriate course of action. Recent improvements MN PMP staff have been working with others on a process for exchanging PMP data across state lines, providing the means for prescribers and pharmacists to more easily identify patients with prescription drug abuse and misuse problems, especially if those patients are crossing state borders to obtain drugs. The BOP has chosen to use the National Association of Boards of Pharmacy’s “NABP PMP InterConnect,” which allows authored users of state PMPs to link to other states’ PMPs. NABP PMP InterConnect currently is deployed in North Dakota, South Dakota, Wisconsin, and 16 other states, with another 10 states committed to or expressing their intent to utilize the solution. This new functionality, which became available in November 2013, will allow approved Minnesota account holders to access the RxSentry MN PMP, entering the name and date of birth of the patient and selecting a state or states from which they would like information on their patient. The data will be returned in a single report, which will be segmented according to the state where the prescriptions were dispensed. Additionally, if there are no records for the patient or if a MN PMP account holder is not authorized to access the data in the other state, it will be noted

in the report results. The NABP PMP InterConnect’s web of information allows appropriate intervention and aids in preventing substance abuse and diversion of controlled substances. What’s ahead? MN PMP staff continues to increase awareness of the RxSentry MN PMP database, encourage prescribers to apply for access, and provide guidance in use of the database. Additionally, the MN PMP Advisory Committee, consisting of representatives from various state agencies, health licensing boards, healthrelated professional associations, and other interest groups, has recommended that the Board of Pharmacy modify the law to make the program more useful. Upon the board’s approval, the MN PMP office will work with legislators to make the necessary modifications. Finally, as use of PMPs becomes a standard part of care delivery nationwide, MN PMP staff will be looking into ways to streamline the process for accessing information. In several states, efforts to integrate the PMP into the electronic health record (EHR) have yielded a workable and well-received solution. We will be watching other states’ progress and will initiate planning efforts for future integration of the RxSentry MN PMP into EHRs. The MN PMP is a step closer to solving the problem of prescription drug abuse. Although the program will not change the circumstances that lead to the abuse of drugs prescribed to help patients, it can help prescribers to feel confident that they are providing prescriptions to patients who are legitimately in pain; helping to prevent inadvertent patient overdose when multiple caregivers are providing treatment; and making it easier for prescribers to identify drug-seekers and deny access to illegitimate prescriptions. Barbara A. Carter is PMP manager for the Minnesota Board of Pharmacy.

Minneapolis VA Health Care System Physician/Physiatrist

The MVAHCS, affiliated with the University of Minnesota, is seeking a Spinal Cord Injury and Disorders BE/BC physician/physiatrist. Duties include providing interdisciplinary care for acute and chronic SCI/D Veterans in the inpatient and outpatient setting. Staff has on-site access to medical and surgical specialties, advanced imaging techniques, and state of the art electronic medical record. Opportunities exist for interacting with medical students, residents, and other health professions trainees. SCI/D Fellows strongly encouraged to apply. Be a part of this dynamic and rapidly growing SCI/D Center in a great location. Must have a valid medical license anywhere in the US. Must be US citizen. VA physicians enjoy an excellent benefits package, paid malpractice insurance, and competitive salary and benefits. Recruitment incentive and student loan repayment may be authorized.

The perfect match of career and lifestyle. Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties: • ENT • Family Medicine • Geriatrician/Outpatient Internal Medicine • Hospitalist • Infectious Disease

For more information: Visit www.usajobs.gov or email your CV to Robyn.Owings@va.gov Telephone 612-467-4337 EEO employer

• Internal Medicine • Med/Peds Hospitalist • OB/GYN • Oncology • Orthopedic Surgery • Psychiatry

• Psychology • Pediatrics • Pulmonary/ Critical Care • Radiation Oncology • Rheumatology

For additional information, please contact:

Kari Bredberg, Physician Recruitment karib@acmc.com, (320) 231-6366

Julayne Mayer, Physician Recruitment mayerj@acmc.com, (320) 231-5052

www.acmc.com

Trinity Health

One of the region’s premier healthcare providers.

Currently Seeking BC/BE • Ambulatory Internal Medicine • General Surgery • Psychiatry

• Urology • Neurology • Otolaryngology

Based in Minot, the trade center for Northern and Western North Dakota, Trinity Health offers the opportunity to work within a dramatically growing community that offers more than just a high quality of life. Comprised of a network of nearly 200 physicians in hospitals, clinics and nursing homes, Trinity Health hosts a Level II Trauma Center, Critical Care Helicopter Ambulance, Rehab Center, Open Heart and Lung Program, Joint Replacement Center and Cancer Care Center. Physicians are offered a generous guaranteed base salary. Benefits also include a health and dental plan, life and disability insurance, 401(k), paid vacation, continuing medical education allowance and relocation assistance.

www.trinityhealth.org

For immediate confidential consideration, or to learn more, please contact

Shar Grigsby Health Center - East 20 Burdick Expressway Minot ND 58702 Ph: (800) 598-1205, Ext 7860 Pager #0318 Email: shar.grigsby@trinityhealth.org

December 2013 Minnesota Physician

genetics and genomics

he growing use of genomic sequencing in clinical practice and the expanded technical capacity to generate genetic information inexpensively are altering the medical landscape. The American College of Medical Genetics and Genomics (ACMG) recently published a policy statement regarding the reporting of “incidental findings” in clinical exome and genome sequencing to patients (Green, RC et al., 2013, Genet Med 15:565-574; the ACMG statement is available as a PDF at www.acmg.net/docs/ ACMG_Releases_Highly-Anti cipated_Recommendations_ on_Incidental_Findings_in_ Clinical_Exome_and_Genome_ Sequencing.pdf). The ACMG’s statement has generated considerable discussion in the medical literature and has implications for patients, researchers, and clinicians. This article briefly reviews the ACMG’s recommendations and the wider implications of the statement.

“Incidental findings” Clinical issues in exome and genome sequencing By Charles E. Gessert, MD, MPH, and Catherine A. McCarty, PhD, MPH

Background The ACMG developed its statement in response to advances in genomic sequencing technology that are expanding its clinical applications. Even the statement’s terminology reflects these advances. What once were called “unanticipated findings” have become “incidental findings”—because today they are anticipated, given the vast amount of information generated through genome sequencing. The ACMG Working Group on Incidental Findings in Clinical Exome and Genome Sequencing identified a set of conditions that should be re-

ported to patients if the conditions are discovered in genetic testing ordered by a clinician. The report’s lead author has noted that the conditions on the list “are likely to have a positive impact upon the health of patients and their families if identified incidentally” (ACMG, public release, Mar. 21, 2013). The initial list includes 24 conditions, including hereditary breast and ovarian cancer, Marfan syndrome, hypertrophic cardiomyopathy, and familial hypercholesterolemia. The ACMG guidelines include five recommendations regarding reporting of incidental findings: 1. Mutations found in the genes relevant to the ACMG’s list of conditions should be reported by the lab to patients, regardless of patient age and the initial indication for sequencing. The ACMG Working Group stated that patients should not be offered the option of declining to receive information about incidental findings because failing to provide the information may constitute medical negligence. 2. Labs should seek and report only the type of variants in genes delineated in the list of conditions. 3. The ordering clinician is responsible for providing pre- and post-test counseling for patients. 4. The recommendations reflect limitations of current technology.

AIRFORCE.COM/HEALTHCARE

Minnesota Physician December 2013

5. The list of conditions should be updated at least annually.

A disclaimer accompanying the ACMG statement notes that the guidelines were designed as a resource for medical geneticists and other health care providers that provide genetic counseling. The statement also advises that significant deviations from the guideline recommendations should be documented in the patient’s record. Key concerns The ACMG’s decision to address the issue of reporting incidental findings of genomic and exome sequencing is understandable, given the advances in the technology. However, the policy statement also raises concerns, particularly in four key areas: • The difficulty of keeping pace with the evolution in genetics knowledge and technology • Public vs. private use of “incidental findings” • Issues of disclosure and consent • Research concerns Evolving technology and “incidental findings” The meaning of “incidental” in genetics/genomics is timebound and fungible. Both our capacity to generate individual genomic information and our capacity to understand its clinical relevance are expanding rapidly. The ethically sound withholding of clinically ambiguous findings of today may well become the ethically unacceptable withholding of clinically important information tomorrow. Our ethical guidelines in genomics have a short shelf life. This is particularly true of guidelines that are condition-specific. The ACMG’s “must report” list of genetic conditions reflects the current state of knowledge. The list should be reviewed and updated at least annually because of the rapid evolution in this field. Incidental findings are a long-standing phenomenon in medicine. Familiar clinical scenarios include those from radiology (the unsuspected bone lesion) and screening programs (the discovery of a skin cancer in the course of routine mammography). Such incidental Incidental findings to page 34

Emergency Medicine

Emergency Practice Associates has immediate full-time, part-time and locums opportunities at our sites in:

Hibbing Little Falls Park Rapids Alexandria Austin

For more information contact Tina Dalton or Mike Coulter at 800-458-5003, email:

recruiting@epamidwest.com or visit our website at

www.epamidwest.com

Your Emergency Practice Partner

Join the top ranked clinic in the Twin Cities A leading national consumer magazine recently recognized our clinic for providing the best care in the Twin Cities based on quality and cost. We are currently seeking new physician associates in the areas of:

• Family Practice • Urgent Care We are independent physicianowned and operated primary clinic with three locations in the NW Minneapolis suburbs. Working here you will be part of an award winning team with partnership opportunities in just 2 years. We offer competitive salary and benefits. Please call to learn how you can contribute to our innovative new approaches to improving health care delivery.

Please contact or fax CV to:

Joel Sagedahl, M.D. 5700 Bottineau Blvd., Crystal, MN 55429

763-504-6600 Fax 763-504-6622

www.NWFPC.com

Urgent Care We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. We are seeking BC/BE fullrange family medicine and internal medicine pediatric (Med-Peds) physicians. We offer a competitive salary and paid malpractice. For consideration, apply online at healthpartners.jobs and follow the Search Physician Careers link to view our Urgent Care opportunities. For more information, please contact diane.m.collins@healthpartners.com or call Diane at: 952-883-5453; toll-free: 1-800-472-4695 x3. EOE

MN Physician 4" x 5.25" 4-color

December 2013 Minnesota Physician

Incidental findings from page 32

findings are medically (and, often, legally) actionable. Customary medical practice is to report such findings to patients; failure to do so would be considered a form of negligence. The urgency of such reporting is proportionate to the need for rapid intervention. For incidental findings in genetics, however, the clinical relevance—and the clinical steps to be taken—may be obscure and may hinge on additional information (genetic, clinical, behavioral, comorbid) to determine both the significance and the urgency of the incidental findings (see Christenhusz, GM et al., 2013, Eur J Hum Genet 21:248–255). For example, genetic risk for type 2 diabetes may not be realized unless found in conjunction with other risk factors such as obesity. Private vs. public data The concept of “incidental findings,” with its implicit

emphasis on the intentions of the clinician or investigator, is a legacy of our cultural focus on individual rights and individual health care. In fact, genomic

findings differ. While reporting findings to patients is principally guided and constrained by considerations of autonomy and respect for individuals, report-

The boundaries between clinical care, public health, and research are breaking down, perhaps for the eventual enrichment of all three fields. data has significant value in epidemiologic work, where the beneficiary might be the public or a defined population (not the individual patient). The ACMG Working Group uses the concept of “reporting” to refer to the disclosure of findings to individual patients and families. However, “reporting” of genetic data may apply to disclosure to the scientific community, such as through the publication of epidemiologic findings. The ethics of and the constraints upon these two types of “reporting” of incidental

ing findings to the scientific community is primarily guided by considerations of beneficence, non-maleficence, and truth-telling. The need to establish standards for both types of “reporting” illustrates the broad array of stakeholders in these issues (see Wolf et al., Genet Med advanced online publication, March 15, 2012). In addition, the public may have a legitimate claim to some types of genetic information, including information that goes beyond the original reasons that the samples were collected. An example is provided by the current efforts of investigators in Michigan to utilize more than 4 million blood spots that were originally collected for newborn screening in broader epidemiological work. The newborn screening was conducted for a specific and narrow purpose and, consequently, additional information from analysis of the blood spots could be seen as “incidental findings.” The broad public benefit of such additional analysis argues for the use of the bloodspots, despite the limited initial purpose and consent. The argument for the use of such materials in research could be strengthened by instituting standard safeguards for the privacy, confidentiality, and even anonymity of the blood and tissue donors. The entire debate over the ethics of reporting of genetic data serves to remind us that the boundaries between clinical care, public health, and research are breaking down, perhaps for the eventual enrichment of all three fields. Disclosure and consent The ACMG statement raises some particularly thorny issues concerning patient disclosure

Minnesota Physician December 2013

and consent. In the future, those recommending genetic analyses, whether for clinical or research purposes, should anticipate incidental findings and provide anticipatory information and/or counseling for patients. The issue of disclosure of such findings should be addressed routinely as well. This is important not simply to assess patients’ preferences for disclosure, but also to provide information on (1) the limited precision of genetic information (in many cases); (2) the potential social and financial consequences of disclosure (e.g., regarding insurability); and (3) the limits that clinicians or investigators may encounter in withholding disclosure such as possible legal consequences of withholding information about a preventable risk. In the future, it may also be appropriate, when discussing genetic analyses, to differentiate between the personal health issues that may arise from incidental findings and the public/ population health uses of genetic information (epidemiology). In time, patients may be asked to indicate their preferences for disclosure to themselves, their families, and their care providers, and may simply be informed that the tissues/samples will also be used for public/ population epidemiologic work, which is not directly related to their individual health. An argument can be made for never withholding disclosure of any incidental findings from individual patients/families, even of neutral or ambiguous genomic findings. This argument holds that genomic findings (individual genomic information) may be regarded as “belonging to” the patient, much as laboratory, clinical, and radiological information is now part of the patient record (which the patient has access to, in many instances). Three principal points support this view: • The current and, especially, the future relevance of the information may be unknown. • The degree of interest in genomic information is likely Incidental findings to page 36

Fairview Health Services

Opportunities available in the following specialties:

Opportunities to fit your life

Dermatology

Fairview Health Services seeks physicians to improve the health of the communities we serve. We have a variety of opportunities that allow you to focus on innovative and quality care. Shape your practice to fit your life as a part of our nationally recognized, patient-centered, evidence-based care team. Whether your focus is work-life balance or participating in clinical quality initiatives, we have an opportunity that is right for you: • Dermatology • Emergency Medicine • Family Medicine • General Surgery • Geriatric Medicine • Hospitalist • Internal Medicine

Olmsted Medical Center, a 160-clincian multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth. Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere.

• Med/Peds • Ob/Gyn • Palliative • Pediatrics • Psychiatry • Urgent Care

The Rochester community provides numerous cultural, educational, and recreational opportunities.

Visit fairview.org/physicians to explore our current opportunities, then apply online, call 800-842-6469 or e-mail recruit1@fairview.org.

Sorry, no J1 opportunities. fairview.org/physicians TTY 612-672-7300 EEO/AA Employer

Rochester Southeast Clinic

Olmsted Medical Center offers a competitive salary and comprehensive benefit package.

Family Medicine

Pine Island Clinic Rochester Southeast Clinic Plainview Clinic

Internal Medicine

Rochester Southeast Clinic Women’s Health Pavilion (Hospital)

Hospitalist

Rochester Hospital

Plastic Surgeon Rochester Hospital

Send CV to: Olmsted Medical Center Administration/Clinician Recruitment 102 Elton Hills Drive NW Rochester, MN 55901 email: dcardille@olmmed.org Phone: 507.529.6748 Fax: 507.529.6622

EOE

www.olmstedmedicalcenter.org

Minneapolis VA Health Care System Great place to work, great place to live.

You are invited to be part of the Department of Veterans Affairs that has been leading change in the health care sector. The Minneapolis VA is a 341-bed tertiary care medical center affiliated with the University of Minnesota. Our patient population and case mix is challenging and exciting, providing care to veterans and active-duty personnel. The Twin Cities area offers excellent living and cultural opportunities. Opportunities for full-time and part-time staff Physicians are available in the following positions: • Gastroenterologist • Emergency Department • Hematology/Oncology • Internist, w/Women’s Health Experience • Compensation and Pension • General Internal Medicine (Minneapolis) • General Internal Medicine (Rice Lake/Hayward, WI Outpatient Clinic) • General Internal Medicine (Rochester, MN Outpatient Clinic) Physician applicants should be BC/BE. Possible recruitment bonus. Interested applicants should email CV to Joan L. Potter, HRMS, Joan.potter@va.gov

Fax 612-725-2287 Telephone 612-629-7306 EEO Employer.

December 2013 Minnesota Physician

Incidental findings from page 34

to be highly individual and unknown or unknowable to the investigator. • Failure to disclose the information, even if the patient prefers non-disclosure, may be actionable in the event of adverse (but preventable) outcomes. In fact, withholding genetic information from a patient may be so difficult in the long run that it may not be an acceptable option. That is, if the clinician or investigator “knows something” that subsequently leads to adverse consequences, the clinician or investigator may be liable for non-disclosure. To reflect these considerations, perhaps consent forms should include these options: (1) full disclosure of all findings (this option should overtly state that interpretation and counseling will be the patient’s responsibility); (2) disclosure of only those findings deemed to be clinically relevant by the cli-

nician or investigator (presumably this option would include counseling); and (3) disclosure of no information except that which requires intervention for the health/well-being of the patient (paralleling the current practice with incidental findings in radiology, for example). In most settings, the option of “no disclosure, under any circumstances” should not be offered, as this would be inconsistent with other ethical principles. Indeed, if the patient adamantly declines to receive any incidental findings from genetic testing, this raises questions about whether the testing should be done. Research concerns Researchers are concerned about loss of research subject autonomy, as well as the cost for required genetic counseling and the potential for decreased participation in research studies to which the ACMG guidelines would apply. Although qualitative research has shown that the majority of research

participants would like to receive all information generated about them in the context of a research study, a significant minority would never want to receive genetic information and would decline to participate in research studies where that was required. This is an especially worrisome possibility, given that participation rates in research studies have been declining for a number of years. More questions Exome and genome sequencing for clinical uses is a rapidly evolving field, driven in large part by advances in cost-effective genome sequencing technologies. The ACMG’s statement is just a beginning. Questions remain about the capacity of physicians to discuss this type of information with patients (for example, will a cardiologist feel comfortable discussing genetic information about a cancer gene?) and the cost of additional clinic visits, genetic testing, and, genetic counselors to provide

pre- and post-testing information. The practical process of documenting the reporting of the information, the limits of the science and technology (e.g., inaccurate results or analyses), and the potential to use such information in population/public health research and reporting must also be addressed. The website for the American College of Medical Genetics and Genomics (www.acmg.net) and the website for the National Human Genome Research Institute (www.genome.gov) are good resources for current information in the field. Charles E. Gessert, MD, MPH, recently retired from the Essentia Institute of Rural Health, Duluth, where he was a senior research scientist and chair of the Institutional Review Board. He also teaches ethics to medical students at the University of Minnesota–Duluth Medical School. Catherine A. McCarty, PhD, MPH, is a genetic epidemiologist and a principal research scientist at Essentia Institute of Rural Health, Duluth.

What if every one of your patients was a learner, an explorer, a writer, a researcher . . . a University of Minnesota student? These are the people you would serve as a Psychiatrist for the University of Minnesota’s Boynton Health Service.

100

400

This is a full-time position with a competitive salary and excellent benefits including CME and professional liability coverage. There are no evening, holiday or on-call commitments. To learn more please contact Steve Hermann, MD, Mental Health Clinic Director (612) 624-1444 or shermann@bhs.umn.edu. Apply on-line at https://employment.umn.edu and reference requisition number 188412.

Minnesota Physician December 2013

Emergency Room Physicians Looking for leisure work hours? • Set your own hours • No contract

Opportunities for full-time and part-time staff are available in the following positions:

• No obligations

Attention Physicians • Immediate openings • Casual weekend or evening shift coverage

• Choose from 12 or 24 hour shifts • Competitive rates • Paid malpractice

Great Emergency Department in Southern Minnesota

763-682-5906 • 1-800-876-7171 F-763-684-0243 michelle@whitesellmedstaff.com

• Associate Director, Primary & Specialty Medicine (IM)

• Medical DirectorExtended Care & Rehab (Gariatrics)

• Dermatologist

• Pain Specialist

• Geriatrician/ Hospice/ Palliative Care

• Psychiatrist

• Internal Medicine/ Family Practice

• Urgent Care Physician (IM/ FP/ ER)

Applicants must be BE/BC.

FAMILY PRACTICE w/OB Warroad, MN Roseau, MN Crookston, MN • Dedicated Team Approach • Competitive Salary & Benefits • EPIC Healthcare Information System Idylic Practice Opportunities located in family friendly communities with close access to some of Minnesota’s most beautiful lakes. Contact: Kerri Hjelmstad, Physician Recruiter Altru Health System PO Box 6003 Grand Forks, ND 58201-6003 1-800-437-5373 Fax: 701-780-6641 khjelmstad@altru.org

US Citzenship requited or candidates must have proper authorization to work in the US. Physician applicants should be BE/BE. Applicant(s) selected for a postion may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reducion Program. Possible recruitment bonus. EEO Employer.

Commpetitive salary and benefits with recruitment/ relocation incentive and performance pay possible. For more information: Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

www.altru.org December 2013 Minnesota Physician

Not “part of the job” from page 11

present. These efforts have brought about positive change. Staff members are reporting incidents more frequently; we are taking a more proactive approach to recognizing patients whose behaviors are escalating; and staff are beginning to get the support they need following an incident. Despite an increase in the number of events, shown in Figures 2 and 3, the graphs also show the proactive efforts of calling security. In May 2013, CentraCare Health sponsored an all-day symposium on workplace violence. This event drew more than 215 attendees from across the state and featured national speakers on prevention of workplace violence and on de-escalalation techniques. CentraCare Health also had the opportunity to share the work on this issue that had been occurring at St. Cloud Hospital.

The symposium closed Conference on Approaches to the Management of Aggressive with a panel of staff memBehaviors in Health Care bers—including a physician, nurse, patient care On June 11, 2014, CentraCare Health will sponsor a conference on innovative assistant, mental health approaches to the management of aggressive behaviors in health care. The associate, and security event will be held at the College of St. Benedict, St. Joseph, Minn. officer—who shared their For additional information, contact the CentraCare-St. Cloud Hospital stories about how a vioEducation Department at 320-255-5642 or sch.education@centracare.com. lent/aggressive situation affected their lives. The The staff’s stories are the The meeting focused on: panel members came from reason this work continues. different backgrounds and • Assessment of patients Until we create an environtraining, but voiced similar who may have a risk of vioment in which threats and acts feelings. All spoke of the fear of lence, and how to intervene of aggression are no longer coming to work; fear for their earlier considered “part of the job,” co-workers on the next shift; • Creation and implementaour work will continue. Staff loss of sleep over the incident; tion of a policy focusing on should not have to lose sleep, the impact on their families, zero tolerance for aggresbe afraid to come to work, or who could not understand what sion and violence in the suffer emotional consequences the staff were experiencing; and health care setting in providing exceptional care to the need for co-worker and systhe patients we serve. tem support in recovering from • Development of an algothe incident. rithm aimed at formally supporting staff following Joy Plamann, MBA, RN, BC, is an event Continued efforts medicine care center director at CentraCare’s St. Cloud Hospital. Our story is not complete. The • Physician education and Holly C. Peterson, MD, SFHM, is interdisciplinary committee at communication a hospitalist with CentraCare Health St. Cloud Hospital conducted • Potential creation of a preSystem. another brainstorming session event team (similar to a this fall to determine the next rapid response team) phase of action plans.

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MENDELSSOHN’S ITALIAN SYMPHONY

MNPhysician_Jan.indd 1

Minnesota Physician December 2013

FEB 21-22 Ordway, Saint Paul FEB 23 Ted Mann Concert Hall, Minneapolis

JAN 17-18 Ordway, Saint Paul

TCHAIKOVSKY’S SERENADE FOR STRINGS

BEETHOVEN’S EIGHTH SYMPHONY

MAR 6 Trinity Lutheran Church, Stillwater MAR 7 Wayzata Community Church, Wayzata MAR 8 St. Paul’s UCC, Saint Paul

FEB 14-15 Ordway, Saint Paul

MOZART AND HINDEMITH

12/16/2013 11:13:37 AM

EDUCATION TRAINING PROGRAM EDUCATION TRAININGTRAINING PROGRAM EDUCATION PROGRAM

LGBTQ Health Professional Development Training Datesan for this training willHealth be held on 2/15,LGBTQ 3/8, 3/22 andissues. 4/5 The first half of the LGBTQ Health Professional Development Training This 4 hour training offers in-depth understanding of specific health LGBTQ Professional Development Training training This is an4 hour LGBTQ it covers general terms and LGBTQ patient For second training offers an in-depth ofguidelines specific LGBTQ health issues. Thecare. first half ofthe the This101; 4 hour training offers understanding an in-depth understanding offor specific LGBTQ health issues. The first half of the halftraining of theistraining, choose one of theguidelines topics below, or they work theFor RHI. antraining LGBTQclients it may covers general terms and forguidelines LGBTQ patient care. Forwith thecare. second is101; an LGBTQ 101; it covers general terms and for may LGBTQ patient the second half of the training, clients may choose the topics below, or they may work with thework RHI.with the RHI. half of the training, clients one may of choose one of the topics below, or they may

Education Manager to develop a custom training:

Education Manager to develop custom training: Education Managerato develop a custom training: 



Caring for transgender patients Caring for transgender patients 

 

GBTQ use GBTQ tobacco tobacco use  GBTQ tobacco use

 

Caring for transgender patients

GBTQ recovery  GBTQ recovery GBTQ recovery

 Creating a competent clinic: Environment, policy & administration  culturally Creating a culturallyclinic: competent clinic: Environment, & administration Creating a culturally competent Environment, policy & policy administration

Length: 4 hours long 4 hours long Length:

Length: 4 hours long

PRA Category 1 Credit s™ 1 Credits™ Earn 4 AMA Earn 4 AMA PRA Category

Earn 4 AMA PRA Category 1 Credits™

This training This is well suitedisfor health and service providers, students pursuing degrees in social training well suited forsocial health and social service providers, students pursuing degrees in social nursing, dentistry, health, and medicine; administrative staff; and health providers. work, is nursing, dentistry, health, and medicine; administrative staff;care anddegrees health care This training wellwork, suited forpublic health andpublic social service providers, students pursuing in providers. social

public health, and medicine; administrative staff; and health care providers. work, nursing, dentistry, The cost of this training is $75 dollars for CEU (to be determined) The cost of this training is $75 dollars for CEU (to be determined)

The cost of this training is $75 dollars for CEU (to be determined)

ACCME Accreditation ACCMEStatement: Accreditation Statement: This activity hasThis been planned implemented accordance with the Essential Areas and Policies of the activity hasand been planned andinimplemented in accordance with the Essential Areas andAccreditation Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Minnesota Medical Association andAssociation Rainbow and Rainbow Council for Continuing Medical Education through the joint sponsorship of the Minnesota Medical Health Initiative.Health The Minnesota Medical Association (MMA) is accredited byis the Accreditation for Continuing Initiative. The Minnesota Medical Association (MMA) accredited by theCouncil Accreditation Council for Continuing ACCME Accreditation Statement: Medical Education to provide continuing medical education for physicians. Medical Education to provide continuing medical education for physicians.

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation AMA PRA Category Credit Statement: AMA 1PRA Category 1 Credit Statement: Council for Continuing Medical Education through the joint sponsorship of the Minnesota Medical Association and Rainbow The Minnesota The Medical Association designates this designates training for this a maximum of 4a AMA PRA Category Credit s™. Physicians Minnesota Medical Association training for of 4 AMA 1PRA Category 1 Credits™. Physicians Health Initiative. The Minnesota Medical Association (MMA) is accredited by maximum the Accreditation Council for Continuing should claim only the credit commensurate with the extent of their participation in the activity. should claim only the credit commensurate with the extent of their participation in the activity. Medical Education to provide continuing medical education for physicians. AMA PRAContact Category 1Brianna.McMichael@rainbowhealth.org Credit Statement:

for hours (612-206-3180)

The Minnesota Medical Association designates this training for a maximum of 4 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The more we get together, the happier and healthier we’ll be.

At MMIC, we believe patients get the best care when doctors, staff and administrators are humming the same tune. So we put our energy into creating risk solutions that help everyone feel conﬁdent and supported. Solutions such as medical liability insurance, physician well-being, health IT support and patient safety consulting. It’s our own quiet way of revolutionizing health care. To join the Peace of Mind Movement, give us a call at 1.800.328.5532 or visit MMICgroup.com.