Minnesota Physician May 2012

Volume XXVl, No. 2

May 2012

The Independent Medical Business Newspaper

The sound of comfort

Music therapy in hospice and palliative care

By Katie Lindenfelser, MMus, MT-BC

I

’d like to sing about the angels that came last night to tell me that I don’t have to go through this anymore,” said 8-year-old Maria, a leukemia patient in a children’s hospital.

The song that Maria wrote during a music therapy session brought comfort and understanding and helped inform her mother and hospital clinicians; her song was Maria’s way of saying that she did not want any more treatments, and it helped her be an active participant in the decisions being made about her health care. Similarly, Ryan, an 11-year-old boy nearing the end of his battle with brain cancer, asked that I play “‘Drift Away” by the Doobie Brothers again and again, as he reported knowing that he was nearing the end of his life and felt his mind and body “drifting away.”

Solving the riddle

PAID

M

innesota is a state that rightly prides itself on providing top-quality, efficient health care. Our hospitals, nurses and physicians have consistently been recognized as a model for patientdriven care that promotes both quality and efficiency. I think the rest of the country could learn a few things from Minnesota, especially as we continue to face challenges in our nation’s health care system.

To rein in costs, we need to have all health care providers across the country aim-

DRUG COSTS to page 10

PRSRT STD U.S. POSTAGE

By U.S. Senator Amy Klobuchar

ing for high-quality, cost-effective results, as we do in Minnesota. But we must also ensure that reform efforts do not result in across-the-board cuts to physician payments.

Fixing the sustainable growth rate will continue to promote access and quality care. I have voted many times to prevent these acrossthe-board cuts because it is the right thing to do and because we need to focus on rewarding quality, integrated care.

Part of rewarding quality care also means we need to look ahead to the future needs of our nation—especially as the baby boom generation begins

Detriot Lakes, MN Permit No. 2655

Ensuring medications are affordable and effective

COMFORT to page 12

IN THIS ISSUE:

Pharmacology Page 20

We protect your peace of mind. And we do it in lots of ways for physicians, facilities and hospitals.

Whatever your situation, we’ve been there, and will be there. We’ve gotten good at it. Excellent, actually, with a proven success rate. It’s a peace of mind movement.

And we’d love to have you along.

Join the Peace of Mind Movement at PeaceofMindMovement.com,or contact your independent agent or broker.

CONTENTS

MAY 2012 Volume XXVI, No. 2

FEATURES Solving the riddle Ensuring medications are afforable and effective

1

By U.S. Senator Amy Klobuchar

The sound of comfort Music therapy in hospice and palliative care

1

By Katie Lindenfelser, MMus, MT-BC

DEPARTMENTS CAPSULES

4

MEDICUS

7

INTERVIEW

8 Arthur Gonzalez, DrPH

18

By Joseph A. Dearani, MD

COMPUTER TECHNOLOGY: Simulating care 28

By Tom Clancy, PhD, MBA, RN

Hennepin County Medical Center

MEDICAL EDUCATION The play’s the thing!

CARDIOLOGY Pediatric cardiac surgery

PUBLIC HEALTH Treating acute stroke patients

30

By Albert W. Tsai, PhD, MPH

14

By Carl Patow, MD, MPH, FACS, and Debra Bryan, MEd

HOSPITALS Long-term acute care hospitals

PROFESSIONAL UPDATE: ONCOLOGY 16 Breaking the silence

By Rahul Koranne, MD, MBA, FACP

34

By Deanna Teoh, MD

SPECIAL FOCUS: PHARMACOLOGY Drug shortages

20

By Darcy Malard Johnson, PharmD

The genome comes to the clinic

22

By Pam Pawloski, PharmD

Special delivery

24

By William H. Frey II, PhD

The Independent Medical Business Newspaper

www.mppub.com PUBLISHER Mike Starnes mstarnes@mppub.com EDITOR Donna Ahrens dahrens@mppub.com ASSOCIATE EDITOR Janet Cass jcass@mppub.com ASSISTANT EDITOR Scott Wooldridge swooldridge@mppub.com ART DIRECTOR Elaine Sarkela esarkela@mppub.com OFFICE ADMINISTRATOR Juline Birgersson jbirgersson@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 necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace legal, tax, business or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 issues) are $48.00. Individual issues are $5.00.

MAY 2012 MINNESOTA PHYSICIAN

3

CAPSULES

Program Reduces Preventable Hospital Visits A pilot study by HealthPartners and Regions Hospital in St. Paul reduced preventable hospital visits by 65 percent among patients who frequently sought care in the emergency department.

The program was launched last August with more than two dozen high-risk patients.

Officials note that nationally, high-risk patients represent less than 1 percent of all hospital patients, but account for as much as 22 percent of health care spending in the U.S. The program used a team of providers, including physicians, nurses, physician assistants, case managers, and other staff, working with patients, to create plans that increased access to coordinated care. A patient’s care plan becomes part of his or her electronic medical record and is flagged as a high priority to ensure the information is visible to providers and staff at HealthPartners hospitals and clinics that care for the patient.

As part of the program, data from two months before care plan implementation were compared to data two months after implementation. The number of ER visits and hospital admissions decreased 65 percent and resulted in an estimated cost savings of $511,000, HealthPartners officials say.

“This pilot study suggests that individual care plans can significantly improve care for this vulnerable subgroup of patients and lower health care costs,” says Rick Hilger, MD, a HealthPartners hospitalist at Regions Hospital.

The program was recently recognized by the Society of Hospital Medicine with a “Most Innovative” award at its annual meeting in San Diego.

Health Plans Profitable In 2011, Report Says Minnesota health plans saw their most profitable year in more than half a decade in 2012, according to figures

released recently by the Minnesota Council of Health Plans (MCHP).

The MCHP’s annual financial report shows that health plans in the state overall had an operating margin of 1.8 percent, the highest margin in the past six years, with $19.8 billion of premium revenue. Plans paid $17.7 billion for medical care, with health care spending up 1.8 percent over 2010.

Health plans in the state saw a slowdown in how much they spent per enrollee, MCHP says. In 2011, per-enrollee spending increased 0.4 percent, compared with a 2.6 percent increase per enrollee in 2010.

The areas that saw the largest increases in spending were outpatient care at hospitals, spending on medical goods, and spending at skilled nursing facilities, all of which saw double-digit spending increases in 2011. Spending for hospitalized patients, prescription drugs, and physician services decreased in 2011.

The report finds that enrollment in plans sponsored by

large employers grew nearly 2.4 percent, to 2.2 million. At the same time group coverage for small companies, with 50 or fewer employees, declined.

More than 14,000 Minnesotans employed by small companies lost coverage in 2011. Enrollment in Medicare plans also grew by nearly 10 percent, to 438,927 enrollees. Overall, enrollment in the seven health insurance companies that make up MCHP increased to 4.3 million, up 1.4 percent.

One of the more notable developments for health plans in the past year was the agreement between plans and the state of Minnesota to cap the profits on Medicaid and MinnesotaCare products that private plans administer for the state. With concerns rising in the Legislature that plans were not being transparent enough about the taxpayer-funded revenues they gained from public programs, health plans agreed to return profits over 1 percent for 2011.

The result is that plans will return a little more than $73

In person

Inbox

When changes in the local health care landscape promised a major influx of new UCare members coming through metro-area clinics and hospitals, we made sure those providers were prepared. In a span of just two weeks, May Ly was among the UCare staff that personally visited 449 unique health care locations to offer a heads-up and explain the impacts. Because being responsive to our partners’ needs isn’t just talk—it’s what we mean by health care that starts with you.

| provider assistance: 1-888-531-1493 | ucare.org/providers |

4

MINNESOTA PHYSICIAN MAY 2012

©2012, UCare.

million to the state. That amount will be shared with the federal government, which splits the funding for Medicaid with states.

State officials say the funds will be credited towards this biennium’s budget. Gov. Mark Dayton credited the work of Human Services Commissioner Lucinda Jesson, who negotiated the deal with health plans.

Between the revenue cap and the state’s new competitive bidding process for public plans, administration officials estimate state taxpayers will see more than $500 million in savings for health care programs.

Researcher Finds Out-of-Pocket Costs Influence Decisions A new study from a University of Minnesota researcher suggests that higher out-of-pocket costs for health services may lead to families cutting back on needed health care treatments for children.

Pinar Karaca-Mandic, PhD, an assistant professor with the U of M’s School of Public Health, followed 8,834 privately insured patients from across the United States whose children were prescribed medication for asthma control. Her report, published in the Journal of the American Medical Association, looked at how the trend of rising out-of-pocket costs for health coverage affected medical decisions in those families.

“We found that among children age 5 to 18 years, children whose families paid more outof-pocket towards asthmacontrol medications used their medications less often,” she said. “And, at the same time, these children were more likely to get hospitalized for asthma.

We didn’t find this effect for younger children, which perhaps reflects that parents are less sensitive to costs for these younger children, whose asthma is typically more severe.”

At a time when health plans are reporting healthy profits, due in part to decreased utilization by enrollees, some experts

have raised concerns about the impact of shifting higher costs to consumers. Karaca-Mandic says her study shows the trend could impact health care delivery overall.

“The result is these children aren’t getting the medicine they need, which can spell serious long-term trouble for them,” she said. “The results signal one of the true impacts of rising insurance costs.”

Sanford Spends $4 Million on Two Airplanes Sanford Health is spending $4.4 million to buy two airplanes to serve as air ambulances for the company, whose facilities cover a very large geographic area.

Sanford, which is headquartered in Sioux Falls, S.D. and Fargo, N.D., calls itself the largest rural, not-for-profit health system in the U.S. The health system has locations in seven states, including a number of hospitals and clinics in western Minnesota. Sanford had formerly leased one airplane, but officials say the two King Air 2000 airplanes will provide better, more reliable service.

“Because our service area spans across 131,000 square miles, it’s important to have an aircraft of this nature available at all times. Commercial aircraft require many hours of maintenance each year; the addition of a back-up airplane virtually guarantees continual availability to transport sick and injured patients throughout a multistate region,” says Tim Meyer, director of emergency air transport for Sanford Health.

Officials say by the end of the year, Sanford’s Fargo air services will include four fixedwing airplanes and four helicopters, with 125 flight nurses and paramedics, 38 pilots, and additional support staff.

MINNESOTA HEALTH CARE ROUNDTABLE

T H I R T Y- S E V E N T H

SESSION

Specialty pharmacy Controlling the cost of care Thursday, June 7, 2012 1:00 – 4:00 PM • Symphony Ball Room Downtown Mpls. Hilton and Towers

Background and focus: Medications treating chronic and/or life-threatening diseases are frequently new products, which are often more expensive than generic or older, branded products that treat similar conditions. The term specialty pharmacy has come to be associated with these medications. Exponents claim the new technology improves quality of life and lowers the cost of care by reducing hospitalizations. Opponents claim the higher per-dose cost spread over larger populations does not justify the expense.

The cost of research, both failed and successful, is reflected in product pricing. Current federal guidelines allow generic equivalents marketplace access based on the patent date, not the release date, of a product. This considerably narrows the window in which costs of advances may be recovered. A further complicating dynamic involves the payers. Physician reimbursement policies sometimes reward utilizing lower-cost “proven” products and cast those prescribing higher-cost products as “over-utilizers,” placing them in lowertiered categories of reimbursement and patient access.

Objectives: We will discuss the issues that guide the early adoption of new pharmaceutical therapies and how they relate to medical devices.

We will examine the role of pharmacy benefit management in dealing with the costs of specialty pharmacy. We will explore whether it is penny-wise but pound-foolish to restrict access to new therapies and what level of communication within the industry is necessary to address these problems. With the baby boomers reaching retirement age, more people than ever will be taking prescription medications. As new products come down the development pipeline, costs and benefits will continue to escalate. We will provide specific examples of how specialty pharmacy is at the forefront of the battle to control the cost of care.

Panelists include: N Sara Drake RPh, MPH, MBA, Pharmacy Program Manager, Minnesota Department of Human Services N Alan H. Heaton, PharmD, RPh, Director, Pharmacy Management, UCare N Daniel Johnson, MEd, Vice President of Public Policy, National Multiple Sclerosis Society N Timothy Stratton, PhD, BCPS, FAPhA, Professor, College of Pharmacy, UMD N Gene Stringer MD, Stillwater Medical Group

Sponsors include: Daiichi Sankyo • Novartis Please send me tickets at $95.00 per ticket. Mail orders to Minnesota Physician Publishing, 2812 East 26th Street, Minneapolis, MN 55406.

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MAY 2012

MINNESOTA PHYSICIAN

5

CAPSULES Capsules from page 5

Bill Changes Rules For Provider Peer Grouping Health care provider groups achieved one of their top legislative priorities this year with the passage of a bill changing provider peer grouping regulations and rolling back the state’s ability to oversee community benefit activity for hospitals.

The bill, H.F. 2237/ S.F. 1809, passed unanimously in the House and Senate and was signed by Gov. Dayton on April 5.

Provider peer grouping, which would rank providers by cost and quality data for use in purchasing health services for state employees, has been seen as a key part of health reform measures passed in 2008. However, questions have been raised about the accuracy and timeliness of the data, and groups such as the Minnesota Hospital Association (MHA) and the Minnesota Medical Association (MMA) also have pushed for

more transparency in how the data are collected and for creating a better appeals process.

According to Lawrence Massa, CEO of MHA, early reports from the state on providers contained errors and raised concerns about methodology. “We just felt there needed to be a stronger appeals process and we really felt that hospitals needed to be able to verify their data,” he says.

Massa says that in 2011, the Minnesota Department of Health (MDH) acknowledged problems with the data but wanted to move ahead with the provider peer grouping system.

That’s when groups such as MHA and MMA started pushing for a change to the law. “If we’re going to publish information on quality and cost that’s going to be out there in the public domain, it needs to be right,” Massa says.

The final bill on provider peer grouping will allow providers to verify data collected by the state, create a strong advisory committee with input from a range of stakeholders, and pro-

vide for a stronger appeals process.

In addition, the bill repeals legislation passed last year that would allow MDH to oversee and approve community benefit activity for hospitals. The bill concerns activities such as immunization drives or other public health services that hospitals provide free of charge. Massa says last-minute changes to the state’s budget in 2011 resulted in giving MDH too much oversight on activities that traditionally have been controlled by local hospital boards. “The language was a bit more heavy-handed than had been intended,” Massa says. “We thought it was a bit of on overreach.”

MDH Debuts Site On Infant Hearing The Minnesota Department of Health (MDH) has combined its online resources about hearing issues with infants into one new website, officials announced in April.

The new site is for parents, providers, and other profession-

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6

MINNESOTA PHYSICIAN

MAY 2012

als looking for resources from the agency’s Early Hearing Detection and Intervention (EHDI) program for infants and children.

Parents of children who have hearing loss or who may develop hearing loss can learn about the EHDI program at the new site, www.improveehdi.org /mn.

The site will provide information on identification and intervention about hearing loss, and will help parents find specialists and education resources.

Providers can access material about best practices, screening processes, support for patients, and training materials.

Correction: The Community Caregiver feature in the March issue of Minnesota Physician contained two factual errors. Roderick Brown, MD, began traveling to Puerto Lempira, Honduras, in 1988, not 1998. Also, Brown is a family physician and general surgeon, not an internist.

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MEDICUS Raymond Iezzi, Jr., MD, is being honored by the Foundation Fighting Blindness with the organizationâ&#x20AC;&#x2122;s 2012 Visionary Award. Iezzi is a consultant in the Department of Ophthalmology at the Mayo Clinic in Rochester, Minn., and holds the academic rank of associate professor of ophthalmology at Mayo Clinic. Iezzi is being recognized for his research in the treatment of retinal degenerative diseases using neuroprotectants, ocular applications of nanotechnology, and retinal prosthesis for restoring vision to the blind. The Foundation Fighting Blindness is a national nonprofit focused on sight-saving research.

Janelle Strom, MD, and David Kloss, MD, have recently joined Tri-County Health Care in Wadena. Strom, an obstetric and gynecological specialist, is a board-certified obstetrics and gynecological physician and a fellow in the American College of Obstetrics and Gynecology. Strom received her medical degree from Janelle Strom, MD the University of North Dakota and completed her ob-gyn residency at Creighton University Affiliated Hospitals in Omaha, Neb. Kloss, a family practice physician and surgeon, received his medical degree from the Milton S. Hershey Medical Center at Pennsylvania State University, and completed his general surgery residency at Staten Island University Hospital in New York City. He is board-certified in general surgery.

Charlotte Roehr, MD, and Michele Brezinski, MD, have joined Courage David Kloss, MD Center Physicians Associates. Roehr will see patients at Courage Center Golden Valley and at Courage Center Burnsville.

A board-certified physical medicine and rehabilitation physician, Roehr is also is board-certified Charlotte Roehr, MD in EMG with a special emphasis in working with clients with brain injury and ALS. In addition to her medical practice, Roehr has been an assistant professor at the University of Minnesota Medical School, Minneapolis. Brezinski comes to the Courage Center from the Park Nicollet Health System. A boardcertified family practice and integrative medicine physician, Brezinski will see patients in the Golden Valley clinic and will do inpatient consultation in the Transitional Rehabilitation Program.

Michele Brezinski, MD Michael Wolfson, MD, has joined North Memorial Clinic, Camden. Wolfson, who is board-certified in internal medicine and a fellow of the American College of Physicians, completed medical school and residency at Rush University in Chicago.

Thomas Kottke, MD, and Courtney Thomas Kottke, MD Jordan Baechler, MD, MS, have been named physician co-chairs for the Twin Cities Obesity Prevention Coalition, a network of physicians, individuals, and organizations working to reduce obesity among children and adults. Kottke is a cardiologist and medical director for evidence-based health at HealthPartners. Baechler was recently named vice president of the Penny George InCourtney Jordan stitute for Health and Healing, where she will Baechler, MD, MS lead efforts to expand the instituteâ&#x20AC;&#x2122;s scope to more broadly include prevention and health promotion. Baechler is a cardiologist and was director of cardiac preventive services at United Heart & Vascular Clinic in St. Paul, where she will continue seeing patients.

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MAY 2012

MINNESOTA PHYSICIAN

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INTERVIEW

A unique health care system ■ Before you became medical director for HCMC,

makes the press. But apart from that, we take care of many patients every day with routine illnesses, all the way from dentistry to obstetrics and transplants—it’s a very busy place.

In this case, like other public institutions around In the future we want to align our facilities a the country, the county commissioners realized little bit better. Our facilities take up about four that the delivery of health care is very unique. It city blocks here, and we have combinations of has a different set of regulations, federal and state, inpatient and outpatient and support and ancillarthat it is constrained by. It also is a much more ies in all the buildings.

We’re trying to rationalize fluid operation in that it’s based on volumes that go that system a little bit better to where we put all up and down, as opposed to more static kinds of the outpatients in one spot. services that are delivered.

We very much need a new facility to treat our So by going to the legislature and creating a psychiatric patients. We do probably more of that public-private partnership—it’s a public benefit corthan anyone else, and we need a new facility that poration that still has a lot of protections for the would deal with both inpatients and outpatients in taxpayers and oversight by the county commissiona contemporary way. ers for key items—it created We also are one of the more flexibility and more flutop three teaching instituidity to be able to deal with We take care of some tions in the state, yet we’ve those circumstances. cannibalized most of our HCMC didn’t change its of the medically complex teaching classrooms, auditoname; it’s just that the parent patients that sometimes riums, and so forth for organization created a new patient needs. If we’re going name, which is Hennepin other don’t handle. to do a good job in the Health System. The reason future, we need to reestablish we did that was to reflect our teaching facilities to accommodate all that that it was more than just a hospital. We’ve got 10 work and research that go on here. clinics around different parts of the community Hennepin County created the Hennepin Health System. What can you tell us about that?

Arthur Gonzalez, DrPH Hennepin County Medical Center Arthur Gonzalez, DrPH, is the chief executive officer of Hennepin County Medical center.

At HCMC, Gonzalez oversees one of the largest hospitals in the state, and a nationally recognized trauma and safety net hospital.

HCMC is part of the Hennepin Health System, which began operations in 2007 as a new governance structure for HCMC and its affiliated clinics and services.

Prior to his role at HCMC, Gonzalez was president and CEO of Tri-City Healthcare District, a public health care system in Oceanside, Calif., for 10 years. Gonzalez is also a Fellow of the American College of Healthcare Executives.

and we thought that more accurately reflected what we did.

■ Hennepin Faculty Associates has been merged

into the hospital. Why did that happen and what does it mean for physicians at the hospital?

With federal reform, [policymakers are] saying, “We’ve got to make one payment to an agency that is providing all of the care.” Having the physicians in a separate organization made sense for the last 23 to 25 years when payment was made on a separate basis. The physicians received payment for what they did; the hospitals received payment for what they did. I think the government, in trying to contain the total cost of care, recognized those two pieces needed to be aligned.

Our history has been that there was a time when [physicians] were part of HCMC, then there was a time when they weren’t. So we’re going back to the format where we’re combined, because it makes the most sense under the way that health care will be delivered in the future.

We did a lot of surveying of the landscape, a frank listing of the different issues on the table, and then we worked through them very diligently and with quite a bit of success. Most people that I’ve spoken to are glad that’s behind us. I think this was a good thing for both organizations.

■ Tell us a little about the affiliated clinics and

services that your system provides.

We offer a wide array of different kinds of services.

I think we’re most known for critical care and trauma and emergency care, because that’s what often

8

MINNESOTA PHYSICIAN MAY 2012

■ What can you tell us about the special needs of

the populations that HCMC serves on a day-today basis?

The patients who come here, in addition to having very complex medical needs, also sometimes don’t have routine access to care. They come in with diseases that are in a more advanced state, which haven’t been managed or taken care of.

Our patients not only have complex medical illnesses, they also have complex social situations.

They may have a family; they may not. They may have a home to go back to; they may not.

This is typical for an institution of this type.

We deal with a lot of complex things. We get referrals from many other hospitals outstate as well as locally. When they see a certain kind of problem that they may not deal with that on a regular basis, they’ll send that to us.

On top of that, we provide a few things that some of the other hospitals don’t offer—for example, our burn center, which we’ve just recently remodeled. We are the poison control center for the area. Probably the most significant service is going to be opening next month: the Hyperbaric Center and Wound Healing Center. That will be state-of-the-art in the nation, and we’re already getting inquiries from around the country and the world from people who want to come and learn about what we’re doing, so we’re pretty excited about that.

■ What does the Accountable Care Act mean for

HCMC? The main thrust of the federal reform law is, when

you peel away all the hundreds of pages of regulation, the government is trying to get control of two things. One is the cost of care. In addition to the cost, the outcomes of care go along with that. Hence the notion of an accountable care organization. They’re saying, we’re going to reimburse one fee for this total cost of care, but there have to be certain outcomes.

Again, the medical staff and the hospital have to be very tightly aligned and very unified in the goals and approaches. It’s not a gimme, or easy; it’s a stretch. I know that all hospitals are struggling with this, and public institutions are right in there with them.

We are all keeping our ears open to see what happens. They may change some things. Regardless of what happens at the federal level, it doesn’t make the problem go away. The fact is, we’ve got baby boomers who are reaching a key point in life when they need more care, and we have a smaller population coming behind to support them than the previous generation did. It’s going to be an issue for the future regardless of who’s in charge and what laws are in place.

It makes sense to prepare.

■ How would you describe HCMC’s place

in the health care marketplace in the metro area?

I am quite impressed with the quality and the caliber of the medical systems that

Minneapolis has. I think we play a special role in medical education, which supplies some of the physicians who end up in those good systems after they graduate from here.

Another role that we play is taking care of some of the medically complex patients that sometimes others don’t handle. I think if we were not present in the area, it would have a significant negative impact on the other local hospitals providing care because they would be receiving a lot of the unfunded patients and underfunded patients that we take care of.

I have enjoyed a good professional relationship with my colleagues in the Minnesota Hospital Association, and I think they recognize our unique role, and I certainly recognize their contributions. It’s a very collaborative environment.

■ How does a public hospital approach the

ongoing issue of uncompensated care?

It’s a very difficult thing. It’s like a rock in a pond. It has its ripple effects. First, you have the uncompensated care that comes from the residents of Hennepin County. Then we also have people who come here for some of these regional services that I talked about earlier, for burns or hyperbaric treatment, who come from other counties, especially the 12-county area that surrounds us.

We have made two appeals to those counties to say, you know, here’s the number

of patients and the dollar amount incurred from residents who live in your area; we would appreciate your consideration for some support. Thus far, when I have gotten a response, it’s essentially been, “We appreciate what you do, but we don’t have any money—ask the state.”

We also have outstate patients who come here, and beyond that we have people who come from other states outside Minnesota, like Iowa or Wisconsin.

The question is, is this a federal responsibility? Is it a state responsibility? I know it should not be solely a Hennepin County responsibility. Yet we don’t really have a resolution.

■ What does the future hold for HCMC?

What I see is that we used to be a hospitalcentric organization that had a little bit of ambulatory care. We’ve been transitioning over a number of years, adding more ambulatory care to that component. There will always be a hospital component, but it will be more of an ambulatory-centric focus, rather than a hospital-centric focus.

I think that will be better for patients as far as accessibility, and it’s also the way health care is transforming technologically as well as economically and philosophically.

We’re preparing to meet that change and that need.

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Drug costs from cover

Drug shortages

to reach retirement age. In Minnesota, the number of people over the age of 65 is expected to double by the year 2030 and will be close to a quarter of the stateâ&#x20AC;&#x2122;s population. As this population grows, we need to look at ways to strengthen our health care system, including Medicare, to ensure our seniors have access to high-quality, reliable long-term care.

Recently, Iâ&#x20AC;&#x2122;ve been hearing

Last year I had the opportunity to meet Axel Zirbes, a cute 4-year-old boy from Minnesota.

Axel has bright eyes and a big smile. He also happens to have no hair on his head. Thatâ&#x20AC;&#x2122;s because Axel is being treated for leukemia.

When Axel was scheduled to start chemotherapy last year, his parents learned that an essential drug (cytarabine) was in short supply and might not be avail-

medication from a pharmacy that still had a supply.

But Axel and his parents werenâ&#x20AC;&#x2122;t alone.

Across the country, hospitals, physicians, and pharmacists are confronting unprecedented shortages of important medications, especially for cancer.

Many of these are generic drug products that have been widely used for years and are proven effective.

The number of drug short-

Part of rewarding quality care also means we need to look ahead to the future needs of our nation from Minnesota physicians and pharmacists about the current crisis involving shortages of many major drugs. Iâ&#x20AC;&#x2122;ve been working to address this problem and Minnesota Physician has asked me to talk about what weâ&#x20AC;&#x2122;re doing in Washington to ensure that providers, pharmacists, and patients continue to have access to affordable drugs.

able for their son. Understandably, they were thrown into a panic and desperately looked for any available alternatives. They even prepared to take Axel to Canada, where the drug was still readily available.

Fortunately, it didnâ&#x20AC;&#x2122;t come to that. At the last minute, the hospital was able to secure the

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ages has nearly tripled over the last six yearsâ&#x20AC;&#x201D;jumping from 61 drug products in 2005 to more than 200 in 2011. A survey by the American Hospital Association found that virtually every hospital in the U.S. has experienced shortages of critical drugs in the past six months.

More than 80 percent reported delays in patient treatment due to the shortages.

For some of these drugs, no substitute drugs are available; or, if they are, theyâ&#x20AC;&#x2122;re less effective and may involve greater risks of adverse side effects. The chance of medical errors also rises as providers are forced to use second- or third-tier drugs that theyâ&#x20AC;&#x2122;re less familiar with. And for patients struggling with cancer, the last thing they want to hear is that they might lose access to an essential medication.

Experts cite a number of factors behind the shortages, including a scarcity of raw materials, manufacturing problems, and unexpected demand.

Business decisions within the pharmaceutical industry are also a factor, such as mergers and cutting back on the production of low-cost generic drugs in favor of more profitable brandname drugs. When drugs are made by only a few companies, a decision by any one company can have a large impact.

Whatever the causes of drug shortages, the results are clear.

Widespread and prolonged

shortages have reached crisis proportions. Pharmacists, doctors, and nurses are spending more and more time looking for medications instead of looking at patients. Thatâ&#x20AC;&#x2122;s just wrong.

Hospitals also report that a flourishing â&#x20AC;&#x153;gray marketâ&#x20AC;? has emerged, with middlemen hoarding scarce drugs and jacking up prices to exorbitant levels.

Under current law, the Food and Drug Administration (FDA) canâ&#x20AC;&#x2122;t require a drug company to report a shortage unless it is the sole source of a â&#x20AC;&#x153;medically necessaryâ&#x20AC;? drug. But even then, there is no penalty if a company doesnâ&#x20AC;&#x2122;t comply.

Last fall, President Obama directed the FDA to speed up its review of alternative drugs and new suppliers. He also ordered the Justice Department to investigate potential price gouging.

And he cautioned the pharmaceutical industry that it would be in its own best interest to be more forthcoming with the FDA about potential shortages.

These are positive steps.

But the fact remains that the FDA remains poorly equipped under current law to respond effectively to the numerous drug shortages.

One solution is the Preserving Access to Life-Saving Medications Act, which I introduced in 2011. It has support from both Democrats and Republicans in Congress; from the president; and from many health care groups, including the American Medical Association.

In effect, this bipartisan legislation would establish an â&#x20AC;&#x153;early warning system.â&#x20AC;?

It would give the FDA the authority to require early notification from a pharmaceutical company at least six months in advance of any planned interruption, disruption, or discontinuation of a drug.

This will help the FDA take the lead in working with pharmacy groups, drug manufacturers, and health care providers to better prepare for impending shortages, to manage shortages more effectively when they occur, and to minimize their impact on patient care. Given that the FDA has successfully averted hundreds of shortages using notification this year, we

know it can make a difference.

The legislation would also direct the FDA to provide upto-date public notification of any actual shortage situation and the actions the agency would take to address them.

The FDA would be required to develop an evidence-based list of drugs vulnerable to shortages and to work with the manufacturers to come up with a continuity-of-operations plan to address potential problems that may result in a shortage.

Alongside this legislation, I am participating in a working group with my colleagues on both sides of the aisle, which is focusing on additional longterm solutions to this drug shortage crisis.

[Ed.’s note: For a pharmacist’s perspective on the drug shortages, see the article on p. 20.]

More research, less regulation

A continued emphasis on affordable, innovative new treatments is also important. That means we need to continue to foster an environment that promotes innovation and research when it comes to new treatments and cures for patients struggling with disease. Minnesota has always invested in research and development to look for new and groundbreaking ways to improve the health of patients. We need to be doing all we can at the federal level to support basic medical research and ensure regulations aren’t stopping a new breakthrough from being developed.

Addressing regulatory burdens in the health care industry will help create a streamlined process for safe, life-saving technologies and treatments to be made available for patients.

That’s why last fall I introduced legislation with Sens.

Richard Burr (R–N.C.), and Michael Bennet (D–Colo.) that would help improve the conflictof-interest provisions at the FDA so the agency can properly utilize outside experts and continue to approve and help develop new treatments for patients. While it’s important to ensure that the process for approving and advising the FDA is free from outside

Our physicians, pharmacists, and patients shouldn’t have to worry about having access to the medication that is necessary for care. influence, it’s also necessary to ensure that the agency is able to take advantage of available expertise.

A coalition of 77 patient advocacy groups—such as the Alzheimer’s Association and the Parkinson’s Action Network— has called for reform to the selection process for FDA advisory committees so that these committees can help boost medical innovation by reducing regulatory burdens that unnecessarily delay beneficial new medical products from reaching patients. The Medical Device Regulatory Improvement Act aims to reform the review and approval process for innovative medical treatments.

Medicare Part D

When new treatments become available, we also need to make sure that patients can afford them. One way to reduce prescription drug costs is to focus on the Medicare Part D prescription drug program that was created in 2003.

The Government Accountability Office found that between 2000 and 2008, the prices of more than 400 brandname drugs increased by at least 100 percent, and in many cases, by as much as 500 percent. As a result of these rising prices, many patients are forced to split pills, skip doses, or not fill their prescriptions at all. Meanwhile, Medicare patients in private plans cost taxpayers about 15 percent more than those covered under traditional government programs.

With the health care reform law, we did succeed in narrowing the dreaded “doughnut hole,” which had been extremely costly for some seniors. But the Medicare Part D law (which passed before I was in the Senate) still prohibits Medicare from directly negotiating lower drug prices from pharmaceutical companies.

Yet, on the other hand, the Veterans Administration (VA) medical system is allowed to

negotiate. As a result, it is able to use its bulk purchasing power to secure significantly lower drug prices.

In fact, by one estimate, if Medicare were allowed to do what the VA does, it would save taxpayers nearly $20 billion per year in lower drug prices. That’s $200 billion over 10 years that could be applied to reducing the federal budget deficit.

Ever since I arrived in the Senate, I have supported legislation that would allow Medicare to negotiate lower drug prices.

And last year, I introduced the Medicare Prescription Drug Price Negotiation Act to give that authority to the Department of Health and Human Services.

The economic reality is that, sooner rather than later, we must do something to reduce the federal budget deficit and rein in Medicare costs. One sure way to do that is by negotiating

lower prices for drugs purchased through Medicare Part D. America continues to provide the highest quality, most technically advanced health care in the world. But our physicians, pharmacists, and patients shouldn’t have to worry about having access to the medication that is necessary for care. Above all, they deserve peace of mind that essential life-saving medications will be there for them when needed.

To follow the progress of these bills and other health care legislation, go to the website of the U.S. Senate (www.senate .gov/) or the U.S. House of Representatives (www.house .gov/).

U.S. Sen. Amy Klobuchar (D–Minn.) was elected to the U.S. Senate in 2006.

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11

Comfort from cover Like medicine, music therapy is a diverse field encompassing the entire lifespan, from prenatal to end-of-life experiences.

Music therapists are employed in a variety of settings, including general and psychiatric hospitals, community mental health agencies, rehabilitation centers, day care facilities, nursing homes, schools, and private practice.

The role of music therapy in promoting healing in a variety of health care settings, including hospice, is growing. And the field has never been more visible to the public than in the past year, as the following examples attest: • “The Music Never Stopped,” a movie based on the case-study essay “The Last Hippie” by neurologist Oliver Sacks, follows the story of a music therapist helping an estranged father and son reconnect following the son’s brain surgery.

• Jodi Picoult published “Sing You Home,” in which the main character is a music therapist.

• Numerous news and media reports examined the role of music therapy in former U.S. Rep. Gabrielle Giffords’ journey toward recovery after a gunshot to head caused severe brain injury.

Though there are therapeutic benefits to playing music simply as entertainment, music therapy involves much more than that. It is an established health care profession that uses music to address specific physical, emotional, spiritual, cognitive, and social needs of individuals of all ages and with a variety of conditions or illnesses.

The American Music Therapy Association (AMTA) reported that in 2009, nearly a million people in the United States received music therapy services in a variety of settings.

Training of music therapists

Those who wish to become music therapists earn a bachelor’s degree in music therapy from one of 72 AMTA-approved colleges and universities. These programs require academic coursework in music therapy;

Hospital and Clinics

Offering comprehensive and integrated psychiatric services including inpatient and outpatient care.

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MINNESOTA PHYSICIAN MAY 2012

psychology; music; biological, social, and behavioral sciences; disabilities; and general studies.

Students learn to assess the needs of clients, develop and implement treatment plans, and evaluate and document clinical changes. In addition to academic coursework, the bachelor’s degree requires 1,200 hours of clinical training, including a supervised internship. Graduate degrees in music therapy focus on advanced clinical practice and research.

At the completion of training, students are eligible to take the national examination administered by the Certification Board for Music Therapists (CBMT). After successful completion of the CBMT examination, graduates are issued the credential necessary for professional practice, Music TherapistBoard Certified (MT-BC). To demonstrate continued competence and to maintain this credential, music therapists are required to complete 100 hours of continuing music therapy education.

Music therapy in the hospice setting

In Minnesota, nearly 30 boardcertified music therapists are working in hospice and palliative care settings, and music therapy has expanded into almost all hospice programs for children and adults in our state.

Whatever an individual’s or family’s cultural practices or religious beliefs, the many elements of music make it accessible and comforting to nearly everyone, at all different times during their end-of-life journey.

There are known benefits to having a music therapist as part of a multidisciplinary, end-of-life care team. Music therapy provides a holistic approach to addressing familiar end-of-life symptoms such as agitation, anxiety, pain, and distress and improving quality of life.

Because music bypasses the neural pathways that inform individuals of pain, a music therapist can help ease a patient’s pain by redirecting the patient to focus on music— rather than the pain—as the stimulus. Similarly, redirecting patients to listen or sing along to

a favorite song often relieves their agitation and anxiety.

Sometimes the words of the song together with the soothing melody bring comfort and greater understanding of life’s journey. At other times, music selected by the patient and family provides a comforting familiarity and an opportunity to reminisce. Even unfamiliar music, improvised on a piano, guitar, or harp, can often bring a sense of peace and release.

Alfred, an elderly man living independently at his home, found that music reminded him of many of his life experiences.

The song “Home, Sweet Home,” for example, validated the many years of comfort Alfred had found in his small, rural homestead following his years of wartime service. During our music therapy visits, he selected and sang songs from the World War I and II era and throughout the 1930s and 1940s. Hearing one song would remind Alfred of another. Even though his shortterm memory was declining, he was able to recall specific details of memories from years ago.

Listening to the music, Alfred’s breathing became more relaxed, he smiled and laughed, his energy increased, and he had relief from his bone pain as his attention was re-directed to a different stimulus: music.

In another scenario providing music therapy, I used rhythm and melody to match a dying woman’s breathing challenges by slowing the rhythm and softening to a lullabye or lament. “My anxiety is relieved and I can just be present to my mom’s journey ‘home,’” said her daughter as she took in the sounds of soft guitar and humming at her mother’s bedside.

Music therapy in pediatric hospice care

For children, music is a natural part of learning and growing.

When a child has a life-limiting condition, music can be essential to supporting the child and his or her family. Sometimes music provides the only opportunity children with life-limiting conditions have to make choices and to have some control over their environment no matter their age or diagnosis (Sheridan

A hospice for children and McFerran, 2004, Aust J Music Ther). Children typically find joy in selecting their favorite instruments (the drum or the maracas) or in directing their sibling(s) to sing a particular song, as a means of expressing themselves and communicating with family members. Many families report that music therapy makes it possible to have fun and forget about the illness or anticipated death, just by being present in the moment and with the music (Lindenfelser et al, 2011, Am J Hosp Palliat Care).

Parents are reminded that their child is still a child.

In a study I conducted with colleagues in 2008, parents reported that music therapy was one of the only memories they had of having fun or feeling “normal” while their child was dying and that it was something they held onto as a way to continue their bond with their child following his or her death (Lindenfelser et al., 2008, J Music Ther). “It was something positive in the midst of dying and letting go and brings me peace knowing that he’s happy,”

My work as a music therapist with children at the end of life and their families, in Minnesota and in Melbourne, Australia, inspired the development of Children’s Lighthouse of Minnesota, a children’s hospice and respite care home. Many of the families I met in Melbourne shared both the value they found in music therapy and also the many benefits of being cared for as a family at Very Special Kids children’s hospice, where music therapy was a special part of their time (Amadoru and McFerran, 2007, Eur J Palliat Care; Lindenfelser et al., 2008, J Music Ther).

The Children’s Lighthouse of Minnesota is a nonprofit organization working to build a children’s hospice home to provide children with life-limiting conditions and their families a place where they can stay to be lovingly cared for at the end of life, or as a special place to have support and rejuvenate during short respite stays. Along with aroundthe-clock clinical and daily care provided at Children’s Lighthouse, music therapy will be included as part of the family-centered model of care.– Katie Lindenfelser, MMus, MT-BC said one mother whose 6-yearold son was nearing the end of life from a rare genetic condition. “During music therapy, he would smile and muster up enough energy to move his fingers to play the chimes!”

Just as young Maria wrote a song expressing her wishes and visions near the end of her life, siblings often write songs about what it’s like not to be able to play with their brother or sister, and to convey all that they wish for him or her through music.

One mother said, “I am so

happy they can sing about how they feel; I didn’t even know until hearing them sing about what this is like for them that they realize he will die.” Children and adults alike are often less self-conscious about using music, rather than spoken words, to express difficult feelings, especially when saying good-bye.

Unique journeys, unique songs

Watching the stress, anxiety, and pain melt from a patient’s face as he or she listens to or engages

in music therapy at the end of life is an honor. Each song and instrument means something different to each hospice patient and family. Everyone has a unique story and journey—and music almost always provides a way to express that story and bring comfort on the journey.

To learn more about music therapy, visit the American Music Therapy Association’s website at www.musictherapy .org/. There you will find music therapy news stories and videos, fact sheets, bibliographies, music therapy publications, and information on how to locate a music therapist.

Katie Lindenfelser, MMus, MT-BC, is a music therapist, massage therapist, and reflexologist. She completed her master’s degree in music therapy and pediatric palliative care at the University of Melbourne in Australia. Lindenfelser is the founder and executive director of Children’s Lighthouse of Minnesota (www.ChildrensLighthouseMN.org).

I am grateful to Amy Furman, MM, MT-BC, for her help in reviewing and revising the manuscript.

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13

MEDICAL

I

f you attend continuing medical education (CME) courses regularly, you know that physician education has been dominated by PowerPoint presentations for years. And while projected slide presentations have their place, they also have limitations. They are relatively easy to prepare, not very costly, and can convey a large amount of scientific information in a short period of time.

However, they are limited in their ability to change behavior, especially when the change requires reflection, insight, and connection to one’s emotions.

Now, advances in adult learning theory have opened the door to more effective learning methods. New approaches in medical education are being used to bring medical education to life. One of these developments, the use of theater, offers physicians exciting ways to learn in a way that projected slide presentations cannot hope to replicate.

There are many topics in medicine that are fundamentally about the human experience and

E D U C AT I O N

The play’s the thing!

Theater performances enhance physician education

By Carl Patow, MD, MPH, FACS, and Debra Bryan, MEd

are best told as stories. For example, patient-physician communication, medical ethics, patient-centered care, and cultural understanding are issues that resonate well with us when

learning experience you had in childhood, perhaps related to sports or school. Often those learning experiences are associated with powerful emotions.

Did the coach or teacher have

Theater can be a valuable means of heightening awareness of patients’ needs, as well as physicians’ well-being. presented as stories, but less so when presented by a speaker standing behind a podium.

Why are stories so compelling? Perhaps the innate connection of emotions to learning is part of the explanation. Think for a minute about an early

“Now when my doctor asks how I feel, I say

grateful.”

some harsh words? Were you embarrassed? Did you feel fearful or anxious? Emotions create lasting memories and are powerful stimuli to learning.

The use of theater also stimulates emotional reactions, which can be very useful as an educational tool. Viewing a story, relating and reacting to it, reflecting on it through discussion, and sharing it with others can create lasting knowledge.

The right story, presented effectively, can lead to changes in physician behavior, and with it improved patient care.

Theater and CME

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How is theater used in continuing medical education? Many different approaches to the use of plays in CME have emerged, especially here in Minnesota. It is not necessary to present entire plays to effectively engage physician audiences. For example, at the Hippocrates Café, created by Jon Hallberg, MD, at the University of Minnesota, professional actors read selections from plays, with the intent of using the selections to promote discussion of medical ethics.

The selections are used to stimulate audience participation, aided by expert facilitation.

Another approach is to present an entire play, perhaps one with a medical theme, as a continuing medical education

activity. In the 1980s, the Mayo clinic, in association with the actor Jason Robards, presented a series of plays that spoke to the patient experience. They included Eugene O’Neill’s “The Iceman Cometh” and “A Long Day’s Journey into Night.” The intent was to expose physicians, including residents and medical students, to stories of the human condition to stimulate empathy, understanding, and reflection on clinical practice. More recently, a play about racism in America, “Miss Evers’ Boys,” written by emergency medicine physician David Feldshuh, has been featured at the University of Minnesota Medical School and at Regions Hospital. This play, written in 1992 and a finalist for the 1992 Pulitzer Prize for drama, was based on the Tuskegee syphilis experiment. It raises many issues of patientphysician relationships, ethics in research, and informed consent.

On a national level, the Institute for Health Improvement and the Association of American Medical Colleges have featured full-length theatrical productions at their large annual meetings. Plays such as “Wit,”

by Margaret Edson, provide the attendees with a learning experience that is experiential, thought provoking, and emotionally charged. The one-act play, which takes place during the final hours of a woman dying of ovarian cancer, was based in part on the playwright’s work experience in a hospital. It is easy to see how physicians, as master observers and problem solvers, can absorb the playwright’s message and integrate it—consciously or subconsciously—into their daily practice.

Tailoring plays to the medical audience

Occasionally it is important to tailor the educational experience for a medical audience or to a single issue. To accomplish this, plays can be commissioned so that the content specifically addresses the issue of interest.

HealthPartners Institute for Medical Education has commissioned many plays and screenplays over the years. Most recently, plays have been commissioned to raise awareness of

patient-centered care and health disparities.

In 2011, the hospitalists at Regions Hospital in St. Paul sought to improve their knowledge of perioperative care. To bring the patient’s experience to life, local playwright Syl Jones was asked to write a short, four-part play.

The play chronicles the experience of a character named Howie as he learns he needs an operation and undergoes a major surgical procedure.

The play was the backbone of a highly interactive, experiential departmental retreat.

Subsequently, hospitalists from the Allina Hospitals and Clinics also viewed the play as part of an initiative on patient-centered care. Participants agreed that hearing Howie’s story and discussing his journey were far more meaningful than seeing a slide presentation with bullet points about patient-centered care.

Similarly, understanding health disparities from the viewpoint of a patient in another culture can be a difficult task for many of us. Recently, HealthPartners worked with playwrights from four different cultural communities—Hmong, Latino, African-American, and Somali—to create screenplays about families in those cultures and their experience of health.

The plays brought to light how cultural preferences can contribute to health conditions, the effect of language and literacy on health, and the challenges health care systems face in meeting the needs of diverse populations. The plays were filmed by Twin Cities Public Television and were presented as part of a yearlong initiative to improve care for diverse communities. A documentary of this work, including segments of the films, can be seen at www.EBANexperience.com.

Physician well-being is another emotionally charged issue that has become increasingly important in Minnesota.

As part of a year-long program to foster physician well-being, HealthPartners commissioned a play for performances at the Guthrie Theater in Minneapolis

Above: An actor at Mixed Blood Theater, ready for “surgery.”

Left: In a play commissioned by HealthPartners, an actor shares the story of a heart surgery patient. in June 2012. The play, by geriatrician William Thomas, MD, is entitled “Play What’s Not There.”

It follows five physicians in a crisis situation that leads them to reflect on their motivations for and dedication to their careers. Again, the use of a story as a device for reflection and discussion is particularly well suited to the highly personal issue of physician burnout and well-being. The website www.physicianwell-being.com includes information about physician health and wellness as well as information about the performances.

ances are very meaningful, and that the impact can be deeply personal and profound. Much like a lesson learned in childhood, the exact emotion that a play produces may be long forgotten, but the memory and

learning can last a lifetime.

Carl Patow, MD, MPH, FACS, is executive director and Debra Bryan, MEd, is manager of experiential education at HealthPartners Institute for Medical Education.

Healthcare Management Resources, Inc. A Minnesota-based healthcare consulting firm specializing in:

The lifetime impact of theater

To some, combining theater and CME may feel like a stretch, but as families, employers, insurers, hospitals, and medical groups pay more attention to the patient’s experience of care, theater can be a valuable means of heightening awareness of patients’ needs, as well as physicians’ well-being. Seeing another side to an issue or experiencing someone else’s reality through a play can be an effective motivator for behavior change.

Of course, creating and presenting theater pieces involves considerable preparation and resources. But our experiences with physician audiences lead us to believe that theater perform-

New practice development Practice management Administrative and accounts receivable services Operational and financial assessments Practice location and lease negotiation Managed care contracts/relationships Marketing Strategic planning for the independent provider

For more information about HMR, please contact: Jeff D. Guenther, President • email to jeff@hmr.net or Rita N. Kieffer • email to rita@hmr.net 2854 Highway 55, Suite 130, Eagan, MN 55121 651-224-4930 • 1-800-467-3845 FAX: 651-224-5273

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PROFESSIONAL

B

loating. Abdominal or pelvic pain. Changes in appetite. Urinary symptoms.

Although they may not be considered typical gynecologic symptoms, these are the most common signs of ovarian cancer.

Because many women with symptoms of ovarian cancer first present to their primary care provider, rather than a gynecologist, it is imperative that all health care providers be familiar with the symptoms and appropriate referral for those who may have this difficult disease.

Identifying the symptoms of ovarian cancer

Ovarian cancer is the ninth most common cancer in women but the fifth most common cause of cancer deaths in women, with a five-year overall survival rate of 44 percent, according to the latest data from the American Cancer Society. Indeed, ovarian cancer is the deadliest of all gynecologic cancers. Patients diagnosed at an early stage have a significantly improved survival rate of 93 percent—however, the

ONCOLOGY

Breaking the silence Understanding the symptoms of ovarian cancer

By Deanna Teoh, MD reality is that fewer than 20 percent of women with ovarian cancer are diagnosed early.

Because there is no reliable screening test as there is for cervical cancer, in the past ovarian cancer has been dubbed “the silent killer.” But thanks to research that has brought about the development of an index of ovarian cancer symptoms, there are now clear signs that women and health care providers should be aware of. The maxim has been updated to a more hopeful one that acknowledges the common presence of subtle symptoms: Ovarian cancer whispers … so listen.

In a landmark study for ovarian cancer research, published in the journal Cancer in 2006, University of Washington researcher Dr. Barbara Goff and

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U P D AT E :

MINNESOTA PHYSICIAN MAY 2012

colleagues found that symptoms of bloating, abdominal or pelvic pain, difficulty eating or feeling full quickly, and/or urinary frequency or urgency more than 12 times per year over a period of less than a year had a sensitivity of 56.7 percent for early-stage disease and 79.5 percent for advanced stage disease. It is important to note that primary peritoneal, fallopian, and ovarian cancers are all diagnosed and treated in the same way.

Based on this study, in 2007 the American Cancer Society, Gynecologic Cancer Foundation, and Society of Gynecologic Oncologists issued a consensus statement on ovarian cancer symptoms. If a woman experiences any of these four symptoms almost daily for more than a few weeks, she should see her health care provider.

The provider’s role in ovarian cancer diagnosis

But what is a health care provider to do when a woman presents with these symptoms? Any woman who meets these criteria should have a thorough evaluation, including a pelvic exam (bimanual and rectovaginal exam), a CA-125 blood test, and a transvaginal ultrasound.

Findings that suggest ovarian cancer are: • Fullness or palpable mass on pelvic exam, especially if the mass is fixed in place, firm, and/or irregular in contour • CA-125 of greater than 35 U/ml • Complex adnexal mass or masses and/or free fluid on ultrasound These days, many women with these symptoms will first be evaluated with a CT scan. CT findings that should raise concerns include the presence of free fluid; peritoneal thickening or nodularity; mesenteric stranding or nodularity; and omental thickening, nodules, or “caking.” in the presence or absence of an

adnexal mass (primary peritoneal cancer is essentially ovarian cancer arising from the peritoneum).

The importance of a gynecologic oncologist

If ovarian cancer is suspected, referral to a gynecologic oncologist is the next important step.

For patients with early stage disease, comprehensive surgical staging including hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymph node dissection, omentectomy, peritoneal biopsies, and pelvic washings is necessary to accurately determine the stage of the cancer and direct proper treatment. In the case of metastatic disease, surgical tumor debulking is performed to reduce volume of disease and increase the efficacy of chemotherapy; this surgery may require peritoneal or diaphragm stripping, bowel resections, or other radical procedures.

Studies have shown that cancer outcomes are improved when ovarian cancer patients are treated by gynecologic oncologists compared to other surgeons. A study of outcomes of ovarian cancer patients in the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database revealed a similar trend, showing that 60 percent of patients with apparent early-stage disease underwent lymph node dissection when treated by a gynecologic oncologist, compared to 36 percent when treated by a general gynecologist and only 16 percent when treated by a general surgeon.

Another study, featured in a 2005 Journal of the National Cancer Institute article, noted that patients with advancedstage disease were more likely to undergo a debulking surgery with a gynecologic oncologist (58 percent) compared to a general gynecologist (51 percent) or a general surgeon (40 percent), and were more likely to receive postoperative chemotherapy when operated on by a gynecologic oncologist (79 percent) or general gynecologist (76 percent) compared to a general surgeon (62 percent).

Key points about ovarian cancer Despite these statistics and a concentrated effort to raise awareness of the importance of a gynecologic oncologist, too many women are not referred to one when ovarian cancer is suspected. In a 2011 survey of more than 1,500 physicians, Goff and colleagues found that only 39.3 percent of family practice providers, 51.0 percent of internal medicine physicians, and 66.3 percent of general gynecologists would refer and/or consult with a gynecologic oncologist in the case of a suspicious adnexal mass.

It is evident that a gynecologic oncologist is a crucial provider for women who will need surgical evaluation for possible ovarian cancer. They play a key role in improving survival rates, and also have a hand in reducing recurrence rates—an important factor to remember in a disease known for its aggressive nature.

Ovarian cancer resources and information

Ovarian cancer patients can have subtle symptoms, and will

Symptoms of ovarian cancer: • Bloating • Pelvic or abdominal pain • Difficulty eating or feeling full quickly • Urinary symptoms, such as urgency or frequency If a woman experiences these symptoms almost daily for more than a few weeks, she should contact a health care provider for a pelvic/rectal exam, transvaginal ultrasound, and a CA125 blood test. If ovarian cancer is suspected, refer the patient to a gynecologic oncologist. often present to their primary care physician for evaluation, making family practice and internal medicine providers important in the fight against this disease. A high degree of suspicion is necessary for diagnosis, and prompt referral to a gynecologic oncologist results in better outcomes for these women.

Fortunately for patients, Minnesota is home to a number of gynecologic oncologists providing care at a variety of locations throughout the state. In Minnesota, gynecologic oncologists can be found through the University of Minnesota, Mayo Clinic, and Minnesota Oncology.

The Foundation for Women’s Cancer website also features a “Find a Gynecologist” tab at

www.wcn.org that directs providers and patients to gynecologic oncologists throughout the country.

Another key resource for women and families faced with ovarian cancer is the Minnesota Ovarian Cancer Alliance (MOCA). A statewide nonprofit organization that reaches out to women, caregivers, and families throughout the state, MOCA is a network of more than 800 ovarian cancer survivors and 45,000 donors, supporters, and volunteers. MOCA provides a variety of services for women with ovarian cancer, from support groups to educational resources and research funding for Minnesota researchers. A wealth of information for patients can be found on the MOCA website at

www.mnovarian.org.

For interested Minnesota physicians and health care institutions, MOCA can facilitate continuing medical education sessions or other in-service training provided by members of MOCA’s medical advisory committee, all of whom are either gynecologic or medical oncologists.

A reason for hope

Despite the sobering statistics, more women with ovarian cancer are finding reason to hope.

Survival times have been increasing and more women experience a remission from their cancer. With a sustained focus on the symptoms and the importance of a gynecological oncologist, we can continue to improve the lives of women with ovarian cancer.

Deanna Teoh, MD, is an assistant professor in the Division of Gynecologic Oncology at the Department of Obstetrics, Gynecology and Women’s Health,at the University of Minnesota Medical School, Minneapolis. She is also a member of the Minnesota Ovarian Cancer Alliance Medical Advisory Committee.

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17

CARDIOLOGY

P

ediatric cardiac surgery is a technically demanding specialty. A child’s heart can be as small as a strawberry, and congenital heart disease (CHD) is the world’s most common major birth defect. According to Children’s HeartLink, one in every 120 children is born with a heart defect. Yet, most heart defects today can be fixed safely with low risk and a high probability of a good long-term outcome.

Pediatric cardiac surgery and infant heart surgery in particular, as it is most often performed now, were introduced in the 1980s and perfected in the 1990s. Advances in the quality of care and outcomes in the pediatric cardiac surgery arena over the last half-century have been astounding. To name a few: • Corrective operations are now routinely recommended for many heart defects, some as early as the day of birth, and many within the first week of life. The risk of mortality related to operation is low (<5 percent), even for some of the most complex lesions, and

Pediatric cardiac surgery On the cutting edge, today and tomorrow

By Joseph A. Dearani, MD

children live well into the adult years with a normal or nearnormal quality of life.

• In the current era, safety in the health care setting is a primary focus, with use of checklists, briefings, debriefings, etc. The most important safe behaviors include attention to detail, clear communication, a questioning and receptive attitude, effective hand-offs, and establishing mutually supportive and respectful behavior with a common goal in mind—the patient.

• Training paradigms and certification for physicians and surgeons caring for patients with congenital heart disease are now expected for hospital credentialing.

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MINNESOTA PHYSICIAN MAY 2012

• Advances in ICU care have facilitated and shortened hospital stays, and integrative therapies such as massage therapy, music therapy, and acupuncture are available in some programs.

• The inclusion of parents in the care of their child, right at the bedside in the ICU, from the day of surgery until they’re dismissed from the hospital, is now considered standard of practice.

Below is a brief summary of and update on current pediatric cardiac surgery procedures.

Advances in procedures

In general, pediatric cardiac surgery procedures are now focusing on less invasive strategies that result in less morbidity and less pain. The importance of a team approach in the care of patients with CHD cannot be overemphasized. This includes a knowledgeable team of professionals that are involved with the care before, during, and after the operation.

New approaches to surgery that are being explored include the use of minimally invasive and robotic approaches to fix selected (usually simple) defects.

[In general, prior heart surgery precludes the ability to offer minimally invasive techniques.]

In children and young adults, very small incisions can be used with the aid of a video thoracoscope, which further reduces recovery time. In minimally invasive heart surgery, cardiac surgeons perform heart surgery through small incisions in the right side of the chest. The operation is performed between ribs and does not involve a sternotomy. This results in less pain and a quicker recovery for most patients.

In some instances, minimally invasive surgery can pro-

vide a better view of some parts of the heart compared to standard open-heart surgery. As with conventional open-heart surgery, minimally invasive surgery also requires stopping the heart (aortic cross-clamping) and diverting blood from the heart using the cardiopulmonary bypass (heartlung) machine.

Potential minimally invasive procedures include aortic valve surgery, atrial septal defect closure, mitral and tricuspid valve surgery, and arrhythmia surgery (maze procedure). Other advantages of minimally invasive techniques may include less blood loss, lower risk of infection, reduced trauma and pain, shorter hospital stay, and smaller and less noticeable scars.

Catheter-based therapeutic procedures have been around for approximately two decades and have included atrial septal defect closure and dilatation and stenting of narrowed blood vessels. The newest percutaneous catheter procedures include valve replacement (most often the pulmonary valve) and ventricular septal defect closure.

These procedures have been particularly helpful in the pediatric population, since there are many anomalies that adversely affect the pulmonary valve, and ventricular septal defect (primary, recurrent, or residual) is relatively common. Catheter approaches involve percutaneous access of a vein or artery in the neck or the groin, and then advancing the catheter into the appropriate cardiac chamber or great vessel and finally deploying it in the proper location.

Hybrid procedures may also be performed as minimally invasive procedures that require a very small chest incision. A catheter is advanced through that incision and into the heart, very similar to the percutaneous technique described above. This may be necessary due to occluded or small peripheral vessels. Valve placement, septal defect closure, and stent placement are all possible with this approach. Collaboration between cardiology and surgery is essential, and the procedures are typically performed in the operating room using sophisticated

CT or x-ray-guided imaging for the intervention.

Fetal cardiac surgery is now available for selected lesions. Fetuses with aortic or pulmonary stenosis and signs of developing hypoplastic left or right heart syndrome may be a candidate for fetal intervention.

Fetuses early in gestation, before 28 weeks, that have not already developed significant myocardial underdevelopment of the heart on the side of the obstruction may benefit from intervention to dilate the obstruction. The fetal procedure requires regional or general anesthesia. An obstructed valve can be dilated using a balloon catheter placed into the fetal heart via a percutaneous maternal approach under ultrasound guidance. In some circumstances, a maternal minilaparotomy is needed. These procedures are offered in only a few specialized centers.

Finally, regenerative medicine aims to restore homeostasis through a broad spectrum of strategies, ranging from transplantation of donor organs to augmentation of innate healing

In general, pediatric cardiac surgery procedures are now focusing on less invasive strategies that result in less morbidity and less pain. processes with stem cell applications. Currently, allogeneic and autologous stem cells derived from natural and bioengineered sources are emerging as new avenues for therapeutic innovation.

The field of adult cardiac regenerative medicine has pioneered the application of cellbased therapy, with more than 3,000 patients worldwide having received cell-based interventions. This experience has demonstrated the safety of the delivery strategies and provides a firm platform to go beyond acquired disease towards regenerative applications for congenital cardiac disease.

The immediate focus of dedicated research programs is to identify the right patient (structural heart disease that is treated with reconstructive surgery and

could be augmented with a regenerative add-on), the right time (a planned operation in which cell-based therapy would have minimal additional risk), and the right cells (autologous cells that are sufficient to regenerate the functional parenchymal tissues), in order to accelerate the field of congenital heart disease and regenerative therapeutics. The future of cardiac reconstructive surgery will no longer be limited by the lack of tissue or functional cardiomyocytes if we are able to fully utilize the regenerative potential of emerging cell-based platforms in a safe and effective clinical pipeline.

Advances have improved quality of life

and perioperative care today, the quality of life for patients has vastly improved. The need for repeat operation(s) later on in life can vary. Some patients may need only one operation as a permanent solution to their CHD. Others may need an additional operation later in life or repeated procedures over their lifetime, most commonly for a valve-related problem.

Importantly, for most patients who require more than one procedure, their quality of life between procedures is generally very good. Over the years, the results of heart surgery in children and infants have dramatically improved to the point that almost all of these children survive into their adult years with a good to excellent quality of life.

Joseph A. Dearani, MD, is a congenital heart surgeon, professor of surgery, and chair of the Division of Cardiovascular Surgery at Mayo Clinic, and is the volunteer medical director of Children’s HeartLink.

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MAY 2012

MINNESOTA PHYSICIAN

19

SPECIAL The past decade has wit-

FOCUS:

PHARMACOLOGY

Drug shortages

nessed major advances

A pharmacistâ&#x20AC;&#x2122;s perspective

in drug development and treatments, as well as

By Darcy Malard Johnson, PharmD

problems related to availability and affordability of medications. This monthâ&#x20AC;&#x2122;s special focus includes articles on the causes and effects of drug shortages; the development of a simple,

A

cute lymphocytic leukemia (ALL) is the most common cancer in children from 1 through 7 years of age and the most common leukemia in children up to age 19, according to the National Cancer Institute. Overall survival for all ages is 66.4 percent, with

noninvasive intranasal

During the first half of 2011, nearly all U.S. hospitals experienced one or more drug shortages.

method of drug delivery that bypasses the bloodbrain barrier to target therapeutics to the brain; and the evolving use of pharmacogenetics information in clinical decision-making.

children under 5 years seeing a 90.8 percent survival rate. Cure rates exceed 80 percent.

Now, imagine bringing your 3-year-old child to a reputable cancer center, finding out he or she has this potentially curable diseaseâ&#x20AC;&#x201D;and then being told

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that several of these life-saving treatments could be in short supply. This scenario has been reality for families of some of the 3,000 children diagnosed with ALL in the past year, due to national shortages of vincristine, cytarabine, and methotrexate, all of which are cornerstone treat-

MINNESOTA PHYSICIAN MAY 2012

ments of ALL. Across the country, each day is a struggle for health care providers due to short supplies of critical medications. Many of these recent shortages involve high-alert medications more likely to cause serious patient harm if involved with an error.

They have included cancer drugs and anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine and electrolytes needed for patients on IV feeding.

Drug shortages have been sharply increasing since 2006 (see Fig. 1 on p. 26). In 2011, we saw an increasing number of shortages, especially those involving older, sterile injectable drugs. The University of Utah Drug Information Service and American Society of Health System Pharmacists (ASHP) reported 267 drug shortages in 2011. Twenty-six of those shortages involved chemotherapy agents.

Drug shortages are a serious issue that is impeding the care of patients. A recent American Hospital Association survey of 820 hospitals revealed that during the first half of 2011: â&#x20AC;˘ Nearly all U.S. hospitals (99.5 percent) experienced one or more drug shortages. â&#x20AC;˘ Nearly half had 21 or more shortages.

â&#x20AC;˘ 82 percent delayed patient treatment. â&#x20AC;˘ 75 percent rationed or restricted scarce medications. â&#x20AC;˘ More than 50 percent couldnâ&#x20AC;&#x2122;t always provide the recommended treatment.

Understanding the causes

To understand the problem of drug shortages, we must understand the causes. While the statistics on these causes vary among sources, there are some general themes.

Manufacturing facility/ quality problems. These include findings of glass shards, metal filings, and fungal or other contamination in products meant for injection into patients. These facility problems may lead to voluntary recalls of drugs that are currently on pharmacy or distributor shelves. Manufacturers are required by the U.S. Food and Drug Administration (FDA) to follow current good manufacturing processes to avoid regulatory action.

The FDAâ&#x20AC;&#x2122;s vigilance is designed to keep medications safe and effective for consumers.

However, we can see the downstream impact on the pharmaceutical market. For example, the FDAâ&#x20AC;&#x2122;s Unapproved Drug Initiative requires that products that came to market prior to the new stringent processes resubmit a New Drug Application, including demonstrating clinical trial data to prove safety and efficacy. Because many of these products are now generic, the high cost of meeting the requirements may lead a manufacturing company to cease production of the drug. This leaves the other suppliers of the drug attempting to produce enough product to meet market demand.

Active ingredient/raw materials shortages. Eighty percent of the raw materials used in production of pharmaceuticals are from outside the U.S., according to an article in the American Journal of Health Systems Pharmacy (AJHSP) (Provisional Observations on Drug Product Shortages: Effects, Causes and Potential Solutions, AJHSP 59, Nov. 2002). In the case of a foreign source, FDA inspects all sites to ensure that the imported

Additional resources product meets U.S. requirements. An article in AJHSP in 2009 noted that “availability problems can arise when armed conflict or political upheaval disrupts trade; animal diseases contaminate tissue from which the raw materials are extracted; climatic or other environmental conditions depress the growth of plants used to produce the raw materials; or raw materials are degraded or contaminated during harvest, storage or transport” (ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems, ASHP 66, Aug 2009).

Increased demand and clinical practice changes. In 2009 the AJHSP reported that occasionally the demand for drug products unexpectedly increases or exceeds production capacity. We may see these types of shortages when a product obtains a new indication or when utilization patterns change due to therapeutic guidelines.

For example, according to the Institute for Safe Medication Practices (ISMP), in 2010 a shortage of morphine caused increased demand for other pain medications, leading to a subsequent hydromorphone shortage.

We are currently experiencing a number of secondary drug shortages due to shifts in utilization from a product that was experiencing a shortage to other alternatives, which now are also in short supply due to increased demand. ASHP has stated that at least 4 percent of drug shortages on sterile injectable drugs are due to increased demand from another drug shortage.

Manufacturers’ production decisions and economics. This category includes manufacturers’ decisions to discontinue a product or to restrict drug product distribution or allocation.

The Food and Drug Administration (FDA) does not require manufacturers to notify the FDA of their plans to discontinue production unless they are the sole producer of that product or the product is medically necessary.

The FDA does not have authority to mandate that another company make a product, even if it is medically necessary, but

For additional information on drug shortages, visit the following websites.

• American Society of Health System Pharmacists: www.ashp.org/DrugShortages • FDA information and drug shortage email notifications: www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm • Discussion of recommendations of the Institute for Safe Medication Practices for organizations managing drug shortages: www.ismp.org/newsletters/acutecare/articles/20101007.asp • Minimum recommendations for health care providers to ensure safe, reliable purchases: https://premierinc.com/about/news/11 -aug/Gray-Market/Gray-Market-Analysis-08152011.pdf

it can encourage companies to do so.

“Just in time” inventory management. This management strategy, credited to car manufacturer Toyota, reduces costs of inventory on hand and optimizes cash flow for health systems, wholesalers, and manufacturers alike. However, a Premier healthcare alliance analysis in March 2011 found that the decrease of on-hand quantities of active ingredients and manufactured drugs creates “risk of instability in the pharmaceutical market” (“Navigating Drug Shortages in American Healthcare,” March 2011).

Data from 2011 show a large number of drug shortages with an “unknown” cause, as reported by the University of Utah Drug Information and ASHP (see Fig. 2 on p. 26). The lack of available information about the cause and duration of drug shortages further complicates drug shortage management and understanding of the causes of drug shortages. The source of information on drug shortages is usually the FDA, the ASHP, or the manufacturer themselves. A suitable alternative product is not usually identified by the source releasing the shortage information, and in some cases an alternative product may not be available.

Effects of drug shortages

Drug shortages have a profound effect on health care systems and patients. The increasing burden of drug shortages has changed clinical practice and potentially compromised patient care. Clinical outcomes are compromised when less efficacious agents are used due to drug shortages. Further, unfamiliarity with replacement agents increases the risk for adverse

effects during drug shortages.

A survey of 1,800 health practitioner respondents, conducted by the ISMP in September 2010, found more than 1,000 adverse drug events due to shortages. Among the findings: • Thirty-five percent of respondents said their facility had experienced an error that could have led to patient harm during the past year due to a drug shortage.

• Twenty-five percent reported errors that had reached patients due to a drug shortage.

• Twenty percent reported adverse patient outcomes due to a drug shortage.

In addition, many respon-

dents reported “high levels of frustration” due to recent drug shortages.

The unproductive time spent by health care providers dealing with drug shortages contributes to health care waste. Pharmacy plays a key role in the management of shortages. Substantial resources are spent investigating the shortages and developing a plan of action, including tracking medication availability; working to obtain or preparing/ administering the alternative products; assisting in rationing drugs in short supply; and collaborating with health care colleagues to develop alternative regimens. The annual labor cost of managing drug shortages in 2010 for all health systems nationwide was estimated at $210 million by the ASHP. Drug shortages also increase the cost of delivering care through higher drug acquisition costs. Non-contract distributors may inflate costs to pharmacies, resulting in increased costs to the health care system. The average markup from these suppliers SHORTAGES to page 26

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MAY 2012

MINNESOTA PHYSICIAN

21

SPECIAL

G

enetic information can improve patient outcomes, aiding clinicians in determining a patient’s disease risk, making a diagnosis, choosing a treatment, drug dosing, and avoiding drug-drug or drug-gene interactions. The Human Genome Project, completed in 2003, has opened the door to identifying breakthrough medicines that reflect a new understanding of the genetic components of disease and therapeutic targets that have given new impetus to the field of pharmacogenetics, the study of genetic factors that influence an organism’s reaction to a drug.

Advances in pharmacogenetics offer the promise of using genetic data in clinical practice, but also raise issues of management of genetic data, staff education and training, evaluation and selection of genetic tests, and guidelines for clinical use.

This article provides a brief overview of the evolution of the field of pharmacogenetics and the issues around utilization of genetic data for clinical decision-making.

PHARMACOLOGY

The genome comes to the clinic Using pharmacogenetic data for treatment-related decisions

By Pam Pawloski, PharmD

History of pharmacogenetics

The term pharmacogenetics was first used in the late 1950s. After the Human Genome Project was completed, the term pharmacogenomics was introduced, referring to a whole-genome approach to pharmacogenetics.

In this article, pharmacogenetics refers to individualized genedrug pairs associated with drug therapy in relation to the incorporation of pharmacogenetic data into clinical practice.

The link between human genetics and chemical exposures was observed in the 19th century, though the first formal study of pharmacogenetics was not published until 1932. In the 1950s, pharmacogenetic

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MINNESOTA PHYSICIAN MAY 2012

research became more generalizable, with studies involving primaquine, isoniazid, and succinylcholine. Since then, scientists have learned much about the genetics of variable drug response related to the cytochrome P450 enzyme system (involved in the metabolism and elimination of numerous widely used drugs), glucuronidation, acetylation, and methylation.

Although the genetic basis for variable drug response relative to drug targets (e.g., receptors) and rare, idiosyncratic adverse drug reactions is less well understood, research in these areas has increased greatly.

Status of pharmacogenetic testing

All of the 20,000 to 25,000 identified human genes are subject to polymorphism; however, many polymorphisms do not have functionally significant effects. Germline and somatic mutations associated with altered expression or activities of gene products and mutations affecting the absorption, distribution, metabolism, and excretion of drugs are common research targets. Additional targets include mutations associated with tumors.

Despite the considerable increase in pharmacogenetic research and knowledge acquired from the Human Genome Project, the incorporation of pharmacogenetic testing in clinical treatment and decision-making has been slow and variable. A recent study found that roughly 10 percent of U.S. Food and Drug Administration (FDA) drug labels incorporated genetic information; however, 25 percent of patients receiving prescriptions take at least one drug with pharmacogenomic information in the label (Frueh

FW et al., Pharmacotherapy, Aug 2008).

Major barriers to widespread incorporation of genetic information in drug labels are the paucity of evidence for practical application (Khoury MJ, Genet Med, Jul–Aug 2003) and a lack of funding to study the translation of pharmacogenetics into clinical and public health practice (Schully SD et al., Genet Med, Jan 2012).

Likewise, there is a need for clinical practice guidelines to inform medication prescribing and treatment management in response to pharmacogenetic information (Relling MV et al, Clin Pharmacol Ther, Oct 2011).

A recent survey showed that, overall, 98 percent of responding physicians agreed that genetic variation influences drug response, but only 10 percent felt adequately informed about pharmacogenomic testing (Stanek EJ et al., Clin Pharmacol Ther, March 2012). Providing a mechanism for educating providers about which tests are accurate and reliable and will influence care is a necessary aspect of testing. Furthermore, pharmacogenetic testing does not perfectly predict gene-drug relationships and subsequent clinical outcomes; therefore, an understanding of test sensitivity and specificity is also necessary.

Ideally, the management of pharmacogenetic testing should include prescriber collaboration with clinical pharmacy, genetic counselors, and laboratory staff to ensure adequate implementation, application, and follow-up.

Patient acceptance of pharmacogenetic testing appears to be positive. In a recent patient survey, no differences in interest by race or socioeconomic status were identified; however, respondents with a history of drug-related side effects and private insurance showed the strongest interest (O’Daniel J et al., Public Health Genomics, 2010).

Clinical decision-making

The National Institutes of Health (NIH) and the FDA are collaborating to move toward a more personalized medicine approach to patient care. They are developing an integrated

Definitions of terms in pharmacogenetics pathway for standards of use of genetic information in drug development and clinical decision-making.

Optimally, pharmacogenetic testing would cost-effectively improve the risk:benefit ratio and generate clinically relevant results. In reality, the most important factor would be evidence that testing changes patient care management.

Logical targets for testing are individuals for whom there might be significant clinical impact (e.g., narrow therapeutic window, associated serious adverse events, improved clinical outcomes) or high-cost treatments. Challenges surrounding testing include therapeutic decisions if testing is clinically indicated but costs are not reimbursed and patients cannot or will not pay.

If clinical practice guidelines are successfully developed based on accepted thresholds of evidence and cost-utility questions are addressed, we would need to consider additional factors associated with widespread implementation of pharmacogenetic

• Allele: An alternative form of a gene (one member of a pair) located at a specific position on a specific chromosome that, in part, determines distinct traits.

• Clinical utility: The ability of a screening or diagnostic test to prevent or ameliorate adverse health outcomes through the adoption of efficacious treatments conditioned on test results.

• Germline mutation: A heritable change in DNA that occurs in a germ cell and, when transmitted to offspring, is incorporated into every cell.

• Locus: The location of a gene or significant sequence of DNA on a chromosome or linkage map.

• Mutation: An alteration in a gene’s genetic message resulting from damage or change.

• Pharmacogenetics: The study of genetic factors that influence an organism's reaction to a drug.

• Pharmacogenomics: The study of how variations in the human genome affect the response to drugs.

• Polymorphism: The occurrence in the same population of more than one allele or genetic marker at the same locus, with the least frequent allele or marker occurring more frequently than can be accounted for by mutation alone (generally >1% frequency of variation).

• Somatic mutation: A change in DNA that occurred in a single cell. testing in clinical decision-making. For example, to decrease over-testing and duplicate testing, providers would need to: • Determine the appropriate provider to maintain responsibility for testing when tests are not disease- or medicationspecific (e.g., genes specific to

cytochrome P450 enzymes) • Develop decision support systems to allow for easier implementation to link genetic variation to a clinical action • Ensure suitable, standardized storage of test data in the medical record for future prescribing and for all providers

• Identify a mechanism to transfer or share test data with providers outside of a patient’s health care system (e.g., referrals) • Determine who will educate patients and how • Identify how testing will be implemented into practice to obtain results in a timely manner for prescribing • Identify processes for followup when close monitoring is necessary • Incorporate ongoing pharmacogenetic education for providers and relevant staff Payer coverage

Payers face similar challenges surrounding the adoption of appropriate testing and test sources. The goals of pharmacybenefit management applicable to pharmacogenetic testing include rational, cost-effective coverage to improve outcomes (Russell Teagarden J and Stanek EJ, Pharmacotherapy, Feb 2012). Clinical programming does not always lower costs, but it should provide value.

GENOME to page 27

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he public is waiting for the medical and scientific community to develop new treatments for Alzheimer’s disease, Parkinson’s disease, frontotemporal dementia, posttraumatic stress disorder (PTSD), stroke, brain tumors, head injury, spinal cord injury, depression, anxiety, autism, and many other disorders of the central nervous system. In the minds of many, the only way to do this is to develop new drugs.

However, drug delivery and formulation are often as important or perhaps even more important than drug discovery. For example, over the last 30 years, hundreds of millions of dollars have been spent trying to create a new drug to treat Alzheimer’s disease that improves memory.

So far, these efforts have failed.

Yet, without developing a new drug, the discovery at the HealthPartners Alzheimer’s Research Center of a simple noninvasive intranasal method of drug delivery that bypasses the blood-brain barrier to target therapeutics to the brain has resulted in a new intranasal

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Special delivery Intranasal treatments bypass blood-brain barrier to treat Alzheimer’s and other brain disorders

By William H. Frey II, PhD

insulin treatment that not only improves memory, attention, and functioning in patients with Alzheimer’s disease but improves memory in normal, healthy adults as well. Remarkably, intranasal insulin does this without altering the blood levels of insulin or glucose. Without having to enter the blood, intranasal insulin travels extracellularly along the olfactory and trigeminal neural pathways from the nasal mucosa to reach the brain and cerebrospinal fluid within 10 minutes.

This new method of intranasal delivery not only allows insulin and other large and charged drugs to enter the brain without the need for modi-

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24

PHARMACOLOGY

MINNESOTA PHYSICIAN MAY 2012

fying the drug, but also reduces systemic exposure and unwanted side effects. Using this delivery method, researchers around the world have successfully treated stroke, brain tumors, Parkinson’s, and other brain disorders in animal models.

Targeting “diabetes of the brain”

Insulin has been used to treat diabetes since its discovery in 1921. We now know that patients with Alzheimer’s disease have a brain deficiency of insulin that prevents them from taking up glucose properly, resulting in a kind of diabetes of the brain (neuroscientist Suzanne de la Monte, MD, has referred to Alzheimer’s as “type 3 diabetes”).

Without glucose, brain cells are deprived of energy and do not function normally; memory and cognition decline; and, with no energy available to replace worn-out parts, the brain degenerates. When insulin enters the brain, it increases the uptake and utilization of glucose in the hippocampus, an area critical to memory. Additionally, it can inhibit the enzyme (GSK3beta) that phosphorylates tau to form the abnormal Alzheimer’s neurofibrillary tangles and increase the production of insulindegrading enzyme that also degrades beta amyloid, which accumulates abnormally in the brains of Alzheimer’s patients.

Further, the intranasally delivered insulin can provide the energy needed to maintain neuronal synapses, which are lost in Alzheimer’s disease.

Intranasal insulin has been shown in four clinical trials in the U.S. to improve memory in Alzheimer’s patients—without the development of a new drug.

In four separate clinical trials in Germany, this same treatment

has also been shown to improve memory in healthy young adults.

[Schiöth, et al., 2012, Molecular Neurobiology (accepted and in press), Brain insulin signaling and Alzheimer’s disease: current evidence and future directions.]

Other researchers in Germany have reported that the intranasal insulin treatment discovered here in Minnesota can attenuate the hypothalamic-pituitary-adrenal axis response to psychosocial stress in young men, raising the possibility that intranasal insulin may even be beneficial as a means of treating or preventing post-traumatic stress disorder. [Bohringer et al., 2008, Psychoneuroendocrinology, Intranasal insulin attenuates the hypothalamic—pituitary—adrenal axis response to psychosocial stress.]

While these results are encouraging, many more studies will be required to obtain FDA approval for the use of intranasal insulin to treat brain disorders.

Stem cell therapy for central nervous system disorders

Therapy using adult stem cells offers another significant hope for treating many central nervous system disorders. Many studies to date have surgically implanted stem cells into the brain. This is an expensive procedure with significant potential adverse side effects. In addition, simply cutting or injecting into the brain to implant stem cells results in neuroinflammation and the release of inflammatory cytokines that kill most of the stem cells once they are implanted. In some clinical trials, stem cells have been administered intravenously, but this distributes the stem cells throughout the body, not just to their intended target in the brain.

Further, only a small number of systemically administered stem cells cross the blood-brain barrier to reach the brain and spinal cord.

My colleagues in Germany and I have shown that intranasally administered adult bone marrow–derived stem cells rapidly reach the brain and spinal cord, and do so without distributing large numbers of stem cells to the heart, liver, kidneys,

spleen, and lungs. When these intranasal stem cells are used to treat animals with Parkinson’s disease, the stem cells migrate preferentially to the damaged areas of the brain by a process involving chemotaxis. Once in the brain, the stem cells rapidly reduce the neuroinflammation characteristic of Parkinson’s disease and, over a period of weeks, dramatically improve motor function in the animals. [L. Danielyan et al., 2011, Rejuvenation Research 14, Therapeutic efficacy of intranasally delivered mesenchymal stem cells in a rat model of Parkinson’s disease.]

Bypassing the blood-brain barrier

Researchers in the Netherlands have also used our intranasal stem cell treatment to successfully treat cerebral ischemia in neonatal animals. Once again, we did not develop a new therapeutic to bring about this success, but rather simply used a new therapeutic delivery system to do so. This discovery of a simple noninvasive intranasal method to bypass the blood-

brain barrier can change the way we treat neurological, psychiatric and behavioral disorders involving the central nervous system.

The blood-brain barrier protects the brain from substances we ingest or that get into the blood that may be harmful to the central nervous system. So why would there be open access to the brain through the nose?

In fact, there is not really easy and open access, since, among other factors, the efficiency of delivery from the nose to the brain is relatively low; very few substances normally get around the nasal turbinates to reach the olfactory epithelium at the roof of the nasal cavity in high enough concentration to reach the brain in an amount sufficient to be harmful; and there is evidence for a P-glycoprotein efflux pump in the nasal mucosa that inhibits delivery of some substances to the brain.

Further, the nose is one of our most important sensory organs. In addition to sensing odors with the olfactory nerves and chemicals with the trigemi-

nal nerves, pheromones are sensed with the nasal vomeronasal organ in lower animals.

However, humans appear to lack a functional vomeronasal organ.

It is possible that in humans, some substances such as pheromones may actually be taken up into the brain along the neuronal pathways described above in order for them to be analyzed there. However, this is just a theory that will need to be investigated.

Potential future applications

In the meantime, the development and testing of intranasal treatments for disorders of the central nervous system continues. According to the website ClinicalTrials.gov (a service of the National Institutes of Health), three centers within the United States, one of which is the HealthPartners Center for Dementia and Alzheimer’s Care, are currently conducting trials studying the efficacy of intranasal insulin in Alzheimer’s disease. In addition to intranasal insulin for Alzheimer’s disease, intranasal delivery of the neuro-

protective drug davunetide is being tested in clinical trials for progressive supranuclear palsy and other tauopathies; intranasal oxytocin is being tested for autism and frontal temporal dementia; and intranasal neuropeptide Y is being tested for PTSD. Considering the pressing need to develop new methods of treating and preventing Alzheimer’s disease and other brain disorders, we can all hope that one or more of these treatments will eventually be found to be safe and effective enough to obtain FDA approval and reach the market.

William H. Frey II, PhD, is director of the HealthPartners Alzheimer’s Research Center at Regions Hospital in St. Paul. He invented and patented intranasal delivery of therapeutic proteins to the brain in 1989, intranasal delivery of insulin to the brain in 1999 and, with Drs. Danielyan and Gleiter, intranasal delivery of stem cells to the brain in 2007.

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MINNESOTA PHYSICIAN MAY 2012

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Premier healthcare alliance 6. Keep records of suspect released a report on drug shortorganizations. ages and non-contract distribu7.

Compare and scrutinize purtors, listing eight best practices chases (i.e., packaging, labelintended to protect health care ing, and contents). Do not use facilities and patients from uninthe products if there are any tentional harm (â&#x20AC;&#x153;Buyer Beware: concerns.

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Consider reporting any susMarket,â&#x20AC;? Aug 2011): pect suppliers to appropriate 1. Understand the risks. authorities/organizations.

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Shortages from page 21

FIGURE 1 decisions about how to prioritize indications for limited agents, which patients to prioritize, and who has the ethical authority to make these decisions.

What can we do?

Doctors should not have to worry about whether or not a drug is available or, worse, to tell patients they canâ&#x20AC;&#x2122;t treat them because a medication isnâ&#x20AC;&#x2122;t available. No provider wants to have to make a decision about which patient to treat if a drug is in short supply. To assist organizations in managing drug shortages, the ISMP released the following recommendations in October 2010: â&#x20AC;˘ Identify drug shortages.

Assign one or more key staff member(s) to remain up-todate on shortages. â&#x20AC;˘ Learn more about drug shortages. Once a shortage is identified, seek out more details, including the estimated duration of the shortage. â&#x20AC;˘ Assess inventory of drugs on hand. Count inventory and estimate how long the supply will last. â&#x20AC;˘ Research the drugs that are in short supply. â&#x20AC;˘ Identify potential therapeutic alternatives early. Create a standard, formal process. â&#x20AC;˘ Prioritize patients and limit use of certain medications. â&#x20AC;˘ Conduct a failure analysis and take action. â&#x20AC;˘ Do not hoard shortage or alternative drugs. This can lead to artificial shortages. â&#x20AC;˘ Establish ongoing communication with staff. â&#x20AC;˘ Engage the ethics committee and risk management staff in the discussion of drug shortages.

FIGURE 2 â&#x20AC;˘ Establish a drug shortage network with other local health care providers. Share information and potential emergency supplies of medications. â&#x20AC;˘ Determine an organizational position on alternative suppliers. â&#x20AC;˘ Proactively monitor adverse events associated with drug shortages.

Patients often are not aware of or cannot comprehend how a drug vital to their treatment is not available. They are frightened and anxious that their outcome, their life, could be threatened by the lack of a critical drug. Providers should be open to conversations with patients about their concerns and the status of drug shortages.

Drug shortages have reached a critical level, presenting a danger to public health by having a negative impact on clinical outcomes; increasing the potential for medication errors if a substitution occurs; causing undue stress and anxiety for patients and providers; and driving up health care costs.

Unfortunately, there is no short-term solution to this problem. As health care providers, we must work together and remain informed in order to meet the needs of patients.

Darcy Malard Johnson, PharmD, is manager of the Oncology Pharmacy Program at Fairview Health Services. Over the past several years, she has had extensive experience in partnering with other stakeholders to manage drug shortages for the oncology service line for Fairview Health Services.

Genome from page 23 Regulatory oversight

The challenges described above do not take into account concerns about direct-to-consumer genetic tests and results that a patient may bring into the physician’s office from another source. There is a strong call for regulatory oversight to ensure proper testing, application of test information, and development of standards to prevent erroneous results due to faulty testing. As a result, the FDA has issued guidance for industry on pharmacogenetic tests and genetic tests for heritable markers, available at www.fda. gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm071075 .pdf. Most tests are Class II or III in-vitro diagnostic and subject to FDA oversight and medical device review; however, not all test manufacturers have complied. A list of letters to manufacturers can be found at www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ InVitroDiagnostics/ucm219582 .htm.

External sources available for use by providers in clinical practice • The National Human Genome Research Institute (NHGRI) offers various training and educational opportunities: www.genome.gov/ • The Centers for Disease Control and Prevention (CDC) supported Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative to assess molecular diagnostic tests for clinical use: www.egappreviews.org/default.htm • Commercial sources of information related to drugs, e.g., Lexicomp: www.lexi.com, the American Hospital Formulary Service: www.ahfsdruginformation.com, and Drug Facts & Comparisons: www.factsandcomparisons.com • Clinical Pharmacogenetics Implementation Consortium (CPIC): www.pharmgkb.org/contributors/consortia/cpic_profile.jsp, the NIH Pharmacogenomics Research Network (PGRN): www.pgrn.org, and the companion Pharmacogenomics Knowledge Base (PharmGKB): www.pharmgkb.org/ provide peerreviewed, updated, evidence-based, accessible guidelines for gene/drug pairs.

• The Genetic Testing Registry (GTR) was launched in early 2012 by NIH as a centralized repository for test providers to share information such as the availability, utility, and FDA status of tests: www.ncbi.nlm.nih.gov/gtr/ Ongoing monitoring and regulatory oversight are necessary to ensure the adoption of appropriate and reliable testing.

Sites should consider adopting guidelines on the use of pharmacogenetic test data generated from outside sources, including external providers and direct-toconsumer tests.

Resources

In the face of conflicting data or differing expert views, it may be difficult to decide which genetic tests to adopt. Identification of the correct body to determine whether a test should be used might occur at the institutional level for providers practicing in an organizational setting (e.g.,

Pharmacy and Therapeutics Committee review, departmental practice agreements). Groups and providers practicing independently or in a small clinic may choose to use external resources (listed in the sidebar) in addition to the FDA label.

Integration in clinical practice

Pharmacogenetic testing has evolved slowly over the past 50 years and is being integrated into clinical practice. Many factors need to be considered, both globally and at the site level, to ensure evidence-based, efficient adoption of testing.

Ultimately, testing may become embedded in care systems (e.g., accountable care organizations) to minimize misuse and waste of resources.

Regardless of how pharmacogenetic data is incorporated, a standardized approach to testing and data handling should be considered.

Pam Pawloski, PharmD, is a research investigator with HealthPartners Research Foundation.

Boynton Health Service

A Diverse and Vital Health Service Welcome to Boynton Health Service >ŽĐĂƚĞĚ ŝŶ ƚŚĞ ŚĞĂƌƚ ŽĨ ƚŚĞ dǁŝŶ ŝƟĞƐ ĂƐƚ ĂŶŬ ĐĂŵƉƵƐ͕ ŽLJŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ŝƐ Ă ǀŝƚĂů ƉĂƌƚ ŽĨ ƚŚĞ hŶŝǀĞƌƐŝƚLJ ŽĨ DŝŶŶĞƐŽƚĂ ĐŽŵŵƵŶŝƚLJ͕ ƉƌŽǀŝĚŝŶŐ ĂŵďƵůĂƚŽƌLJ ĐĂƌĞ͕ ŚĞĂůƚŚ ĞĚƵĐĂƟŽŶ͕ ĂŶĚ ƉƵďůŝĐ ŚĞĂůƚŚ ƐĞƌǀŝĐĞƐ ƚŽ ƚŚĞ hŶŝǀĞƌƐŝƚLJ ĨŽƌ ŶĞĂƌůLJ ϵϬ LJĞĂƌƐ͘ /ƚ͛Ɛ ŽƵƌ ŵŝƐƐŝŽŶ ƚŽ ĐƌĞĂƚĞ Ă ŚĞĂůƚŚLJ ĐŽŵŵƵŶŝƚLJ ďLJ ǁŽƌŬŝŶŐ ǁŝƚŚ ƐƚƵĚĞŶƚƐ͕ ƐƚĂī͕ ĂŶĚ ĨĂĐƵůƚLJ ƚŽ ĂĐŚŝĞǀĞ ƉŚLJƐŝĐĂů͕ ĞŵŽƟŽŶĂů͕ ĂŶĚ ƐŽĐŝĂů ǁĞůůͲďĞŝŶŐ͘ ŽLJŶƚŽŶ͛Ɛ ŽƵƚƐƚĂŶĚŝŶŐ ƐƚĂī ŽĨ ϮϱϬ ŝŶĐůƵĚĞƐ ďŽĂƌĚ ĐĞƌƟĮĞĚ ƉŚLJƐŝĐŝĂŶƐ͕ ŶƵƌƐĞ ƉƌĂĐƟƟŽŶĞƌƐ͕ ƌĞŐŝƐƚĞƌĞĚ ŶƵƌƐĞƐ͕ D Ɛͬ>WEƐ͕ ƉŚLJƐŝĐŝĂŶ ĂƐƐŝƐƚĂŶƚƐ͕ ĚĞŶƟƐƚƐ͕ ĚĞŶƚĂů ŚLJŐŝĞŶŝƐƚƐ͕ ŽƉƚŽŵĞƚƌŝƐƚƐ͕ ƉŚLJƐŝĐĂů ĂŶĚ ŵĂƐƐĂŐĞ ƚŚĞƌĂƉŝƐƚƐ͕ ƌĞŐŝƐƚĞƌĞĚ ĚŝĞƟƟĂŶƐ͕ ƉŚĂƌŵĂĐŝƐƚƐ͕ ƉƐLJĐŚŝĂƚƌŝƐƚƐ͕ ƉƐLJĐŚŽůŽŐŝƐƚƐ͕ ĂŶĚ ƐŽĐŝĂů ǁŽƌŬĞƌƐ͘ KƵƌ ŵƵůƟĚŝƐĐŝƉůŝŶĂƌLJ ŚĞĂůƚŚ ƐĞƌǀŝĐĞ ŚĂƐ ďĞĞŶ ĐŽŶƟŶƵŽƵƐůLJ ĂĐĐƌĞĚŝƚĞĚ ďLJ , ƐŝŶĐĞ ϭϵϳϵ͕ ĂŶĚ ǁĂƐ ƚŚĞ ĮƌƐƚ ĐŽůůĞŐĞ ŚĞĂůƚŚ ƐĞƌǀŝĐĞ ƚŽ ŚĂǀĞ ĞĂƌŶĞĚ ƚŚŝƐ ĚŝƐƟŶĐƟŽŶ͘ ƩĞŶĚŝŶŐ ƚŽ ŽǀĞƌ ϭϬϬ͕ϬϬϬ ƉĂƟĞŶƚ ǀŝƐŝƚƐ ĞĂĐŚ LJĞĂƌ͕ ŽLJŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ƚĂŬĞƐ ƉƌŝĚĞ ŝŶ ŵĞĞƟŶŐ ƚŚĞ ŚĞĂůƚŚ ĐĂƌĞ ŶĞĞĚƐ ŽĨ h ŽĨ D ƐƚƵĚĞŶƚƐ͕ ƐƚĂī͕ ĂŶĚ ĨĂĐƵůƚLJ ǁŝƚŚ ĐŽŵƉĂƐƐŝŽŶ ĂŶĚ ƉƌŽĨĞƐƐŝŽŶĂůŝƐŵ͘

Gynecologist/Clinical Supervisor ŽLJŶƚŽŶ ,ĞĂůƚŚ ^ĞƌǀŝĐĞ ŝƐ ƐĞĞŬŝŶŐ Ă 'LJŶĞĐŽůŽŐŝƐƚ ƚŽ ƐĞƌǀĞ ĂƐ ůŝŶŝĐĂů ^ƵƉĞƌǀŝƐŽƌ ĨŽƌ ƚŚĞ tŽŵĞŶ͛Ɛ ůŝŶŝĐ͘ dŚĞ ůŝŶŝĐĂů ^ƵƉĞƌǀŝƐŽƌ ǁŝůů ĞŶƐƵƌĞ ƐƚĂī ĂĚŚĞƌĞŶĐĞ ƚŽ ƌĞůĞǀĂŶƚ ƌĞŐƵůĂƟŽŶƐ͕ ĂƐƐƵƌĞ ŚŝŐŚĞƐƚ ƉƌŽĨĞƐƐŝŽŶĂů ĂŶĚ ĞƚŚŝĐĂů ƐƚĂŶĚĂƌĚƐ͕ ĂŶĚ ǁŽƌŬ ǁŝƚŚ ƚŚĞ ŝƌĞĐƚŽƌ ĂŶĚ ŚŝĞĨ DĞĚŝĐĂů KĸĐĞƌ ŝŶ ĨŽƌŵƵůĂƟŶŐ ůŽŶŐ ƌĂŶŐĞ ƉůĂŶŶŝŶŐ ĂŶĚ ƉŽůŝĐŝĞƐ͘ ƐŵĂůů ƉĞƌĐĞŶƚĂŐĞ ŽĨ ƟŵĞ ǁŝůů ďĞ ƐƉĞŶƚ ƉƌŽǀŝĚŝŶŐ ĐůŝŶŝĐĂů ĂŶĚ ƚĞĂĐŚŝŶŐ ƐĞƌǀŝĐĞƐ ĨŽƌ ƚŚĞ ĐĂĚĞŵŝĐ ,ĞĂůƚŚ ĞŶƚĞƌ KďͲ'LJŶ ĞƉĂƌƚŵĞŶƚ ĂŶĚ hŶŝǀĞƌƐŝƚLJ ŽĨ DŝŶŶĞƐŽƚĂ WŚLJƐŝĐŝĂŶƐ͘ dŚŝƐ ƉŽƐŝƟŽŶ ŽīĞƌƐ Ă ĐŽŵƉĞƟƟǀĞ ƐĂůĂƌLJ ĂŶĚ Ă ŐĞŶĞƌŽƵƐ ĂĐĂĚĞŵŝĐ ƐƚĂƚƵƐ ƌĞƟƌĞŵĞŶƚ ƉůĂŶ͘ WƌŽĨĞƐƐŝŽŶĂů ůŝĂďŝůŝƚLJ ĐŽǀĞƌĂŐĞ ŝƐ ƉƌŽǀŝĚĞĚ͘ ƉƉůLJ ŽŶͲůŝŶĞ Ăƚ ŚƩƉƐ͗ͬ​ͬĞŵƉůŽLJŵĞŶƚ͘ ƵŵŶ͘ĞĚƵ ĂŶĚ ƌĞĨĞƌĞŶĐĞ ƌĞƋƵŝƐŝƟŽŶ ŶƵŵďĞƌ 176093͘ dŽ ůĞĂƌŶ ŵŽƌĞ͕ ƉůĞĂƐĞ ĐŽŶƚĂĐƚ ,ŽƐĞĂ KũǁĂŶŐ͕ ,ƵŵĂŶ ZĞƐŽƵƌĐĞƐ ŝƌĞĐƚŽƌ ;ϲϭϮͿ ϲϮϲͲϭϭϴϰ͕ ŚŽũǁĂŶŐΛďŚƐ͘ƵŵŶ͘ĞĚƵ͘ dŚĞ hŶŝǀĞƌƐŝƚLJ ŽĨ DŝŶŶĞƐŽƚĂ ŝƐ ĂŶ ƋƵĂů KƉƉŽƌƚƵŶŝƚLJ͕ ĸƌŵĂƟǀĞ ĐƟŽŶ ĚƵĐĂƚŽƌ ĂŶĚ ŵƉůŽLJĞƌ

ϰϭϬ ŚƵƌĐŚ ^ƚƌĞĞƚ ^ ͻ DŝŶŶĞĂƉŽůŝƐ͕ DE ϱϱϰϱϱ ͻ ;ϲϭϮͿ ϲϮϱͲϴϰϬϬ ͻ ǁǁǁ͘ďŚƐ͘ƵŵŶ͘ĞĚƵ

MAY 2012

MINNESOTA PHYSICIAN

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COMPUTER

M

odern hospitals are complex systems of interwoven relationships and social networks.

Changes in one process can impact the entire system.

Decision-making is difficult because outcomes are affected by numerous variables in the hospital environment. These variables include the people who work there, the patients and their responses to treatment, the availability and functioning of equipment, and the use of different protocols.

Analyzing alternatives

What if hospital administrators had a crystal ball that allowed them to see the results—both intended and unintended—of their decisions before they made an investment of time, effort, and dollars?

Thanks to the emerging field of complexity science, they now have the next best thing: the ability to make predictions using databased models that simulate the interaction of multiple variables.

Simulating care Databased modeling and serious gaming will shape health care in the 21st century

By Tom Clancy, PhD, MBA, RN

Let’s say that the hospital administration wants to modify the workflow so that patients in the emergency department will have a shorter wait. Before making any changes, department managers consult with the staff and map out the current workflow. Then they create alternate maps or flow charts and analyze how changes would affect emergency department staff, patients, and other areas of the hospital.

This process is known as scenario analysis, and in the past, it was done on paper.

Creating valid models

Today using computers, we can create models that are far more complex, run various scenarios, and see how the system reacts to

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MINNESOTA PHYSICIAN MAY 2012

changes over time. Although the models look simple, the underlying statistical analysis is based on complex mathematical formulas. Once created, the models must be validated. This is done by entering existing data into the model—length of wait, day and time of arrival, staffing patterns, admissions criteria, and so on—and comparing the results with the observable, reallife situation.

Once the model is validated, new values can be substituted for existing data, and the results analyzed. Sometimes the results are unexpected: For example, a new policy that benefits patients by reducing waiting time in the emergency department may create difficulties for the nurses who work there. When this happens, the parameters of the scenario can be tweaked and the simulation run again to see what happens in the model.

Different models of hospital operations can be linked to create a “virtual hospital.” This comprehensive model allows administrators to see how even small changes affect the entire system—because nothing happens in isolation. For instance, increasing admissions through the emergency department may create backups in radiology.

• Family Medicine

Capturing the benefit

• Emergency Medicine

Simulation models can capture incremental benefits that are hard to measure. Here’s an example: In some hospitals, nurses wear devices that allow them to communicate with every other nurse on the unit. When they need assistance with a patient, they don’t have to look for another nurse. They can use the device to ask for help.

But the devices are expensive, and some administrators were reluctant to invest in them.

Then a simulation model showed that nurses who used

• Hospitalist

Contact: Todd Todd o Bym Bymark, ark, tb tbymark@cuyunamed.org ymark@cuyunamed.org www.cuyunamed.oorg (866) 270-0043 / (218) 546-4322 | www.cuyunamed.org

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TECHNOLOGY the devices spent up to two hours less looking for help and resources needed to care for patients. The model allowed administrators to attach a dollar amount to the time saved and predict overall cost savings.

Models can also be used as a tool to help staff embrace change. If we want to simulate how nurses work on the unit, we can involve them in building the model. This means that the nurses are helping create the change, and the process itself becomes a consensus builder.

From macro to micro

At some point, these macro- or institutional-level simulations converge with the use of simulation on the micro- or individual level. For example, we might analyze various scenarios to determine the quickest way to transport a patient having a heart attack from home to the emergency department and then to either the catheterization lab or the operating room. Scenarios might include doing an EKG and administering medication in the ambulance en route, directing the ambulance to an emergency entrance reserved specifically for heart attack patients, and taking the patient into a special area of the emergency department.

Once the problem of optimal flow is solved, we need to ensure that members of the health care team have the skills necessary to provide optimal care. To do this, we turn to a different kind of simulation: serious gaming, or immersive simulation.

Playing to learn

Serious games are those created for a primary purpose other than entertainment. In 2008, serious gaming was already a $1 billion industry, and it is estimated that it will grow to $15 billion by 2015. Gaming is increasingly used in aviation and military training, corporate education, and other sectors to achieve measurable, sustained changes in performance and behavior.

A growing body of research has found that online games are effective learning tools. The immersive simulation of gaming

offers consistent, engrossing training that is individually tailored to the needs of the learner.

The learner can practice procedures and solve problems repeatedly, resulting in better retention of knowledge. In fact, interactive simulations have been shown to have learning retention rates of 75 percent to 80 percent. This far exceeds the retention rates of 15 percent to 20 percent for standard videoor lecture-based training. These high rates of retention occur because as users “play,” they are creating new neural pathways in the brain that will shape their responses in real-life clinical practice.

At the School of Nursing, we believe that serious gaming can improve the way students and practicing nurses are educated.

That’s why we recently entered into an exclusive agreement with VitalSims, a commercial developer of gaming applications for health care. Together we are developing a series of web-based simulations for nurses on a wide variety of topics. These learning games will be easily accessible at school, home, or work, using any web browser on a computer desktop, iPad, tablet, or mobile phone.

Shaping clinical practice

One simulation, developed by Niloufar Hadidi, PhD, CNS, APRN, BC, assistant professor at the School of Nursing, involves assessing a hospitalized 77-yearold woman for the risk of falling. The “player” must take into account intrinsic and extrinsic factors, such as the patient’s medical history, medications, and environmental variables. Hadidi based the simulation on her clinical experience at the University of Minnesota Medical Center, Fairview, where she formerly chaired the Fall Prevention Committee.

Currently in the planning stage are scenarios that will immerse users in emergency departments, operating rooms, and intensive care units where they can practice essential skills.

Also in development are scenarios that will address infection control and patient safety.

What if hospital administrators had a crystal ball that allowed them to see the results—both intended and unintended— of their decisions before they made an investment of time, effort, and dollars?

In addition, VitalSims is creating scenarios for physicians. Soon-to-be released is a serious game that uses simulated patients to teach about diabetes management. Collectively these scenarios will promote interprofessional training among nurses, physicians, and other key members of the health care team.

Shorter clinical experience

Serious gaming allows students to practice clinical skills until they become almost second nature. As a result, it is likely that in the future, nursing and medical students, as well as those in other health disciplines, will need to do less hands-on learning at clinical sites. This will save time and money and make it easier for students to earn their degrees—without compromising their education.

Serious gaming will prepare students for work in the “sim lab.” Because students will arrive at the lab with a good knowledge of basic clinical skills, they will learn more when working with the simulation mannequins and other equipment. They will also have more time for interprofessional experiences that will prepare them for the collaborative teamwork needed in today’s health care setting.

When students begin their clinical experience, they will be well prepared to care for real patients. As a result, they will be able to receive the maximum benefit from a shorter clinical experience. This is important because finding and arranging clinical experiences is often challenging due to an increase in nursing students, shorter patient stays, and the move to outpatient care.

Step by step

We believe that in the future, serious gaming will be the first step in clinical education. After using immersive simulation of gaming, students will move on to the simulation center, where they will be able to focus on higher-level critical skills, communication, coordination, and teamwork. Finally, at the clinical site, students will be able to focus more on patients than procedures.

This progression will allow students to achieve better mastery of clinical skills and use their time in the simulation center more efficiently. It will also ease the problem of finding enough clinical sites and will

shorten the length of clinical experiences.

When today’s health care students become practicing professionals, it is likely that serious gaming will be an important part of their continuing professional education. Whether they use gaming on their own or as part of formal coursework, they will be playing to learn new skills and update their knowledge. In this vision of the future, complex databased modeling on the institutional level will converge with immersive simulation of serious gaming on the individual level to improve health care delivery in the 21st century.

Tom Clancy, PhD, MBA, RN, is clinical professor and assistant dean for faculty practice, partnerships, and professional development at the University of Minnesota School of Nursing. He previously served as vice president of professional services at Mercy Hospital in Iowa City, Ia.

Internal Medicine?

Family Medicine?

Yup.

NEW clinic in Mahtomedi, MN?

Internal and Family Medicine Opportunities Stillwater Medical Group is an 90+ provider multi-specialty group practice affiliated with Lakeview Hospital. For more than 50 years we have been providing comprehensive healthcare services in the St. Croix Valley, just east of the Twin Cities metro area.

Internal and Family Medicine Physician Opportunities: Stillwater Medical Group has exciting new Internal and Family Medicine Physician opportunities at our NEW Mahtomedi, MN clinic opening Fall 2012! Additional opportunities also available in Stillwater, MN. Mahtomedi, MN? (Ma-toe-me-dye) So what if you can’t pronounce it? We can help with that. Mahtomedi is located in Washington County, on the east shore of White Bear Lake. Residents appreciate the community’s small town charm, lakeside flavor, and close proximity to the Twin Cities Metropolitan Area. In addition, the Mahtomedi School District and other area colleges offer excellence in education.

For further information please contact: Patti Lewis, Director Human Resources 1500 Curve Crest Blvd, Stillwater MN (651) 275-3304, plewis@lakeview.org stillwatermedicalgroup.com MAY 2012

We’ll make it all better.

MINNESOTA PHYSICIAN

29

PUBLIC

Treating acute stroke patients

Y

ou are enjoying a weekend at the cabin and suddenly you can’t seem to move your right arm. It doesn’t really hurt, but it just won’t work. It feels weak. And come to think of it, your whole right side feels a little weak. You suddenly feel dizzy.

When your wife looks up at you from her morning coffee, she immediately sees that you are having some sort of problem and wonders if you are having a stroke. “Of course not,” you say, “I just slept on my back and arm funny.”

Your wife stares at you and tells you to sit your stubborn backside down while she pulls out her cell phone and calls 9-1-1.

She tells the operator, “I think my husband is having a stroke. His speech is slurred and he is having some right side weakness—please send an ambulance right away!”

If the above scenario occurred while you were home in the Twin Cities, Rochester, or St. Cloud, emergency medical services (EMS) would assess and triage the stroke and transport you to the best-equipped hospital—a certified primary stroke

Orthopaedic Surgery Opportunity Live in Beautiful Minnesota Resort Community

Minnesota develops a comprehensive, system-based approach

By Albert W. Tsai, PhD, MPH

center (PSC)—which would be less than a half-hour away.

However, you are at the cabin in rural Minnesota; the nearest hospital is more than 30 minutes away and is not a certified PSC. It’s a critical access hospi-

Timely, expert treatment: a life-and-death difference

More than one-third of Minnesotans live over 60 minutes away from a PSC. Rural areas of Minnesota have the

A coordinated system will provide a platform for understanding where resources are needed to improve care. tal with a stellar reputation for great care—so you’re told, at least. Is this hospital ready to diagnose and treat you?

Two BC/BE Orthopaedic Surgeons wanted to join four orthopaedic surgeons at Sanford Bemidji Orthopaedics Clinic in Bemidji, Minnesota. Part of an 85-physician, multi-specialty group practice and 118 bed acute care hospital. 1:6 call anticipated. Competitive compensation/benefits package, paid malpractice, relocation assistance and more. Sanford Health of Northern Minnesota has 1,450+employees and is part of Sanford Health system based in Fargo, ND and Sioux Falls, SD. Bemidji, Minnesota, located in northwestern Minnesota, is a beautiful resort community offering exceptional schools, a state university, and yearround cultural activity as well as great access to the outdoors for year-round recreation activity. To learn more about this excellent practice opportunity contact: Celia Beck, Recruiter Physician Placement Office – Bemidji Phone: (218) 333-5056 Fax: (218) 333-5360 Email: celia.beck@sanfordhealth.org AA/EOE

30

H E A LT H

MINNESOTA PHYSICIAN MAY 2012

highest population of seniors, the group most impacted by stroke, but they also have the longest travel times to PSCs. With stroke, time lost is brain lost. Nearly one in three stroke victims arrive first at a small, rural hospital, which highlights the need to make sure that every community hospital emergency room is equipped to treat acute stroke patients. This is not to say they can’t receive good stroke care in greater Minnesota, but currently there is no system to coordinate the resources each hospital and community brings to the table.

According to the American Heart Association, nearly 795,000 people suffer a stroke each year in the United States.

In Minnesota, stroke takes the lives of more than 2,000 people and is the primary reason for nearly 12,000 hospital admissions each year, with direct annual hospitalization charges of more than $367 million. Far too many Minnesotans die or are disabled from stroke because they do not get brain-saving emergency treatment in time and don’t end up at the best facility to fully treat their acute stroke. Timely and expert treatment can mean the difference between returning to work or

becoming permanently disabled; living at home or living in a nursing home. It can be the difference between life and death.

Right now, we lack coordination among Minnesota’s communities, EMS, and hospitals regarding stroke triage, transport, and treatment. It is unnecessarily costing us lives and increasing health care costs, when the solution is relatively simple: to coordinate and communicate between ambulance systems, hospital systems, and communities so that stroke patients, especially those in rural Minnesota, can be triaged and transferred quickly to the hospitals best equipped to treat them.

Thankfully, the solution is in progress. It involves getting ambulance systems to use evidence-based protocols to assess and triage stroke patients; getting rural hospital systems to coordinate resources and expertise; and getting more hospitals to become acute stroke-ready, meaning they can provide both expert emergency intervention before transferring to a tertiary care facility—and, if necessary, follow on admission for stroke care.

To coordinate, we first need to adopt standard protocols for ambulances and emergency medical services. Standard protocols allow EMS to better assess and triage stroke patients in the field, and to know which facility is best equipped to take them. We can advance care and stroke patient outcomes by identifying and equipping hospitals in every corner of the state to treat acute stroke patients for immediate intervention and provide follow-up on care, and by encouraging hospitals to collect and submit data to a database so we can track and implement quality improvements.

Establishing a statewide system of care

The process of developing a system-based approach to treating stroke in Minnesota is already underway with the leadership of the American Heart Association/American Stroke Association and the Minnesota Department of Health. Under STROKE to page 32

Practice Well. Live Well.

Lake Region Healthcare is located in a magnificent, rural, and family-friendly setting in Minnesota lakes country where we aim to be the state’s preeminent regional health care partner.

Our award winning patient care and uncommon medical specialties set us apart from other regional health care groups. Lake Region’s physicians and their families also enjoy an unmatched quality of professional and personal life.

Current opportunities including competitive salary and benefit packages available for BE/BC physicians are: • Dermatologist • Family Medicine • Emergency Medicine

• Hospitalist • Internal Medicine • Pediatrics

For more information contact Barb Miller, Physician Recruiter bjmiller@lrhc.org • (218) 736-8227

712 Cascade St. S., Fergus Falls, MN 736-8000 • (800) 439-6424 Lake Region Healthcare is an Equal Opportunity Employer. EOE

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 • General Surgery • Geriatrician/ • Outpatient Internal Medicine

• Hospitalist • Infectious Disease • Internal Medicine • OB/GYN • Oncology • Orthopedic Surgery

For additional information, please contact:

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

www.lrhc.org

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

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

www.acmc.com

Emergency Medicine Emergency Practice Associates has immediate full-time, part-time and locums opportunities at our sites in: The Northwest Wisconsin Region of Mayo Clinic Health System has more than 300 physicians representing a wide range of medical specialties in a community healthcare setting. We are a respected and financially secure organization with strong emphasis on high quality care and patient satisfaction. A Mayo One emergency medical helicopter is based in Eau Claire, offering surrounding communities access to the area’s only verified Level II trauma center.

Our current opportunities include: Dermatology Oncology Emergency Medicine Orthopedic Surgery – General, Sports, & Trauma Endocrinology Palliative Care Family Medicine Pathology General Surgery PM & R Hospitalist Psychiatry – Adult Internal Medicine Rheumatology Neurology Urology If you wish to learn more or to express interest in this position, please contact: Cyndi Edwards/Christie Blink by phone (800-573-2580); email edwards.cyndi@mayo.edu or blink.christie@mayo.edu

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 MAY 2012 MINNESOTA PHYSICIAN

31

2012 Minnesota Stroke Conference

Stroke from page 30 the Minnesota Heart Disease and Stroke Prevention State Plan 2011–2020, a statewide Minnesota Acute Stroke System Council has been established and charged with developing and implementing a comprehensive stroke system of care for Minnesota. The council, which has been meeting monthly since March 2011, includes expert representation from across the state and across areas of medicine and health policy. The goal is to develop a framework for the system and launch voluntary participation in the system within the next two years.

We believe that establishing a system will improve care for all people across the state—but not simply because there are standards that EMS providers and hospitals will be asked to meet. A coordinated system will provide a platform for understanding where resources are needed to improve care. It will allow current outreach efforts to continue while at same time establishing a more coordinated

The 2012 Minnesota Stroke Conference will take place June 4, 2012, at the University of Minnesota Continuing Education and Conference Center, St. Paul, Minn.

The conference is intended for stroke program coordinators, nurses, physicians, quality improvement directors, rehabilitation specialists, health educators, EMS professionals, and stroke advocates.

Attendees will learn about the latest developments in acute stroke treatment and management, and how to apply recent translation research in EMS and pre-hospital care, hospital care, and transitions in care postacute stroke and have the opportunity to network with other health care professionals, public health professionals, and stroke advocates in Minnesota.

For information, visit www.mnstrokepartnership.org/conference .html or call (651) 201-5412. approach to educating, training, and equipping hospitals around the state for improving stroke care.

Physicians can get involved in this process by joining the council and providing input into the system. In particular, physicians who staff emergency departments are valuable to this process. Medical directors who provide medical direction for EMS agencies can be involved by making sure that the stroke protocol that their Advanced Life Support (ALS) and Basic Life Support (BLS) services are

Family Medicine St. Cloud/Sartell, MN We are actively recruiting exceptional part-time or full-time BC/BE family medicine physicians to join our primary care team in Sartell, MN. This is an out-patient only opportunity and does not include labor and delivery or hospital call and rounding. Our current primary care team includes family medicine, adult medicine, OB/GYN and pediatrics. Previous electronic medical record experience is preferred but not required. We use the Epic electronic medical record system at all of our clinics and admitting hospitals.

Our HealthPartners Central Minnesota Clinics – Sartell moved into a new primary care clinic in the summer 2010. We offer a competitive salary, an excellent benefit package, a rewarding practice and a commitment to providing exceptional patient-centered care.

St Cloud/Sartell, MN is located just one hour north of the Twin Cities and offers a dynamic lifestyle in a growing community with a traditional appeal.

For more information, please contact diane.m.collins@ healthpartners.com or call Diane at 800-472-4695 x3. EOE

using are consistent with the statewide stroke protocol being developed right now.

Primary care physicians also play a role in the success of the system. Primary prevention— risk factor management (blood pressure control, blood cholesterol control, diabetes management, physical activity, smoking cessation, and dietary adjustments) are key in preventing most strokes. Patients rely on you to be actively involved in managing their risk factors to prevent a stroke—and if they’ve had a stroke already, to work

with them to prevent a secondary cardiac or stroke event.

The Minnesota Acute Stroke System aims to provide a framework for the coordination of stroke care—so that the people of Minnesota can be assured that they will receive the highest quality of care, should they unfortunately have a stroke, no matter where they are in the state.

For information about joining the Minnesota Acute Stroke System Council, or if you’d like to provide input into the development of the statewide acute stroke system, contact the Minnesota Department of Health at (651) 201-5413 or health.stroke@ state.mn.us. Visit us online at www.health.state.mn.us/cvh, keyword “stroke.” For information about the upcoming annual Minnesota Stroke Conference, see the sidebar on this page.

Albert W. Tsai, PhD, MPH, is the principal investigator and program director for the Minnesota Stroke Registry program at the Minnesota Department of Health.

Practice Well.

Live Well.

Lake Region Medical Group is seeking a full-time Certified Physician Assistant to join our Lake Region Healthcare team of 3 orthopedic surgeons; providing care in a multi-specialty clinic with 50+ providers.We are looking for a hardworking, conscientious individual committed to providing quality care to our patients as we develop our Orthopedic Center of Excellence.

Duties will include new and follow-up patient visits, assisting with surgery, post-op visits and hospital rounds in our 108 –bed community based hospital.The ideal candidate will have 2-5 years experience in orthopedics.

We offer a competitive salary with a healthy benefit package.

For more information contact Barb Miller, Physician Recruiter bjmiller@lrhc.org • (218) 736-8227

712 Cascade St. S., Fergus Falls, MN 736-8000 • (800) 439-6424 Lake Region Healthcare is an Equal Opportunity Employer. EOE

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32

MINNESOTA PHYSICIAN MAY 2012

www.lrhc.org

7KH 6N\ÂśV WKH /LPLW

LQ /LWWOH )DOOV 01 Chief Medical Officer Rice Memorial Hospital has an outCandidates submit a cover standing opportunity for the right letter and resume to: person to serve as its Chief Medical Michael Schramm, CEO Officer (CMO).

Rice Memorial Hospital Reporting directly to the CEO, this 301 SW Becker Avenue Willmar, MN 56201 senior executive will be responsible for leading the medical staff in the planRice provides a competining, facilitating and implementing of tive salary and generous programs to enhance physician effecbenefit package. To learn tiveness, quality of practice, clinical more see our website at integration and patient satisfaction. www.ricehospital.com The CMO will be line administrator for physician services within the Emergency Department and is expected to provide direct patient care at least four shifts per month in the Emergency Room.

The position requires an MD or DO with a license to practice medicine in the State of Minnesota; as well as a minimum of seven years of clinical experience and at least two years of physician leadership experience. An MBA or Masters degree in public health is desirable.

Located in the lakes region two hours west of the Twin Cities, Rice Memorial Hospital is the stateâ&#x20AC;&#x2122;s largest municipal hospital, providing a vast array of services to the residents of west central Minnesota, including high-tech diagnostics, rehabilitation, long-term care, DME, mental health, dialysis, radiation oncology and hospice. Rice recently completed a $52 million building and renovation project.

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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.

THE STRENGTH TO HEAL

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Learn the latest treatments and play an important role in the care of Soldiers and their Families. As a physician on the U.S. Army Reserve Health Care Team, youâ&#x20AC;&#x2122;ll continue to practice in your community and serve when needed. Youâ&#x20AC;&#x2122;ll work with the most advanced technology and distinguish yourself while working with dedicated professionals. Youâ&#x20AC;&#x2122;ll make a difference.

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Opportunities for full-time and part-time staff are available in the following positions: â&#x20AC;˘ Deputy Chief of Staff â&#x20AC;˘ Gastroenterologist â&#x20AC;˘ General Internal Medicine â&#x20AC;˘ Physician â&#x20AC;&#x201D; Spinal Cord Injury Physician applicants should be BC/BE. Possible recruitment bonus.

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33

HOSPITALS

F

rom 2000 to 2005, I lived in Starbuck, Minn., and worked in a 20-bed critical access hospital. There weren’t many options available within rural population-based health care for the sickest of the sick.

When a patient needed tertiarylevel and ICU care, our team would occasionally need to send the individual to the Twin Cities.

There, the patient would receive critical care and then move on to receive the next level of medical care and therapy in the most appropriate facility available in order to heal to the highest possible level of wellness. If that patient was lucky, he or she might be able to return home or to the local skilled nursing facility.

Now, I live and work in the Twin Cities as medical director of Bethesda Hospital, in St. Paul, one of two long-term acute-care hospitals (LTACHs) in the state (the other is Regency Hospital, in Golden Valley).

Through the efforts of state and national health care organizations over the past decade, the health care continuum now

Long-term acute care hospitals An essential element in the care continuum

By Rahul Koranne, MD, MBA, FACP

offers more post-acute care options in both rural and urban communities: skilled nursing facilities (SNFs), transitional care units (TCUs), inpatient rehab facilities (IRFs), and home health agencies (HHAs), as well as LTACHs. But not every physician is familiar with the role that these different care sites play in treating acutely ill, complex medical patients. On a nearly daily basis, other physicians ask me: What exactly does an LTACH do?

What is a long-term acute care hospital?

LTACHs are licensed specialty hospitals focused on providing acute medical care to critically ill patients with complex condi-

tions over an extended period of time, as compared to community or tertiary short-term acute care hospitals (STACHs). Currently, there are approximately 430 LTACHs in the United States. They are accredited by the Joint Commission and reimbursed by Medicare and other public and private insurers.

LTACHs were created in the 1980s to enable medically complex patients to be discharged from acute hospitalizations, in part as a way to control Medicare spending on the highutilization, critically ill patient.

Medicare data indicate that LTACH patients are “the sickest of the sick”; they tend to have the highest acuity as measured by a case mix index (CMI), as compared with traditional postacute care providers (i.e., home health, skilled nursing facilities, TCUs and inpatient rehab facilities). Bethesda Hospital has the highest CMI in the state.

Patients don’t live permanently at an LTACH; the average length of stay for LTACH patients on Medicare is 25 days, though some patients may stay for longer or shorter periods.

The specialty hospital focuses on preparing a patient to 1) live independently and ultimately return to his or her home community or to 2) achieve the highest level of wellness possible and then move on to the next level of care such as a skilled nursing facility, transitional care unit, or private home with home care services.

Admissions criteria

LTACH patients require constant medical management by a physician and advanced nursing care staff. Their conditions include, but are not limited to, multiorgan or multisystem failure including respiratory and cardiac complications, postsurgical

34

MINNESOTA PHYSICIAN MAY 2012

or organ transplant complications, complex wounds, multiple injuries, and traumatic or acquired brain injury. Over 40 percent of our patients need help being weaned from a ventilator; some require inpatient dialysis. These patients are often referred directly by intensivists or hospitalists from ICUs and must undergo a clinical assessment, meeting certain criteria to ensure that they need ongoing acute care prior to their admission to Bethesda Hospital.

The top four criteria indicating a patient is ill enough to require LTACH services are: • The patient needs ongoing care at an acute hospital level.

• The patient requires daily physician visits to monitor and change plan of care.

• The patient has had an admission at a short-term hospital of greater than five days.

• A lower level of care has been unsuccessful, and the patient has now been readmitted to the original hospital.

Bethesda recently began offering a unique identification process (the Bethesda Hospital Trigger Tool) that helps referring physicians and case management staff know when is the right time to call upon our expertise to serve the needs of their patients who are ready to make a transition. This tool integrates with different electronic health records (EHRs) to compare patients’ conditions (i.e., DRGs) to specific triggers that meet Bethesda Hospital criteria.

The tool generates a patient list for case managers and physicians each day to focus their attention on and connect with Bethesda for a potential referral and transition. Not all of these patients would eventually get transferred, but the Trigger Tool helps decrease the staff’s reliance on memory of a patient’s condition and instead hardwires the use of specific criteria into their decision-making.

LTACHs offer comprehensive, personalized medical treatment and therapies designed to improve outcomes for medically complex patients. They also provide a variety of medical and rehabilitation services that are LTACHS to page 36

St. Cloud VA Health Care System

FAMILY PRACTICE w/OB

is accepting applications for the following full or part-time positions:

Crookston, MN and Roseau, MN

• Associate Chief, Primary & Specialty Medicine (Internist-St. Cloud)

• Country Lifestyle....

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• Chief, Primary & Specialty Medicine (Internal Medicine) (St. Cloud)

Idylic Practice Opportunities located in family friendly communities. Leave the hassle and bustle of the city behind.

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Opportunities available in the following specialties:

Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere.

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

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

• NP/PA (Montevideo)

• Disability Examiner (IM or FP) (St. Cloud)

• Psychiatrist (Brainerd, St. Cloud)

• ENT (St. Cloud)

• Radiologist (St. Cloud)

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Olmsted Medical Center, a 150-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth.

• Medical DirectorExtended Care & Rehab (IM or Geriatrics) (St. Cloud)

• Dermatologist (St. Cloud)

Contact: Kerri Hjelmstad, Physician Recruiter Altru Health System PO Box 6003 Grand Forks, ND 58201-6003

Family Medicine Rochester Southeast Clinic Rochester Northwest Clinic Wanamingo Clinic Chatfield Clinic Dermatology Southeast Clinic

• Internal Medicine/ Family Practice (Alexandria, Brainerd, St. Cloud, Montevideo)

• Weekend Medical Officer of the Day (IM or FP) (fee for service appointment, St. Cloud)

US Citizenship required or candidates must have proper authorization to work in the US. J-1 candidates are now being accepted for the Hematology/Oncology positions.

Physician applicants should be BC/BE. Applicant(s) selected for a position may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction Program. Possible relocation bonus. EEO Employer.

Excellent benefit package including:

Child Psychiatry Southwest Clinic Hospitalist OMC Rochester Hospital

Favorable lifestyle

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26 days vacation

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Interested applicants can mail or email your CV to VAHCS Send CV to: Olmsted Medical Center Administration/Clinician Recruitment

St.Health Cloud VA Care System Brainerd | Montevideo | Alexandria

1650 4th Street SE Rochester, MN 55904 email: egarcia@olmmed.org Phone: 507.529.6610 Fax: 507.529.6622

www.olmstedmedicalcenter.org

EOE

Sharon Schmitz (Sharon.schmitz@va.gov) 4801 Veterans Drive, St. Cloud, MN 56303 Or fax: 320-654-7650 or Telephone: 320-252-1670, extension 6618

MAY 2012 MINNESOTA PHYSICIAN

35

LTACHs from page 34 not routinely offered at other types of post-acute facilities, such as care of complex wounds and injuries and inpatient dialysis. In addition, they offer comprehensive laboratory and radiology services on site. LTACHs offer a staff of medical specialists and subspecialists. The Bethesda Hospital staff includes pulmonologists, neurologists, psychiatrists, psychologists, nephrologists, pathologists, geriatricians, physiatrists, palliative care, infectious disease physicians, and general and plastic surgeons; the hospital also has in-house respiratory, pharmacy, laboratory, radiology, case management, and social service expertise.

Core competencies offered

by LTACHs include respiratory care (including ventilator weaning) and complex medical care; few, such as Bethesda, also offer neurovascular care (both medical behavioral care and brain injury services). A key service is successful ventilator weaning, which means that patients will be less likely to be readmitted to

LTACH patients are “the sickest of the sick.” the hospital after LTACH discharge, and that patients will be able to retain personal mobility; travel to physical therapy; free themselves from heavy, restrictive medical equipment; regain their vocal abilities so they can clearly indicate their needs; heal more quickly; and, hopefully, have more choice when it comes to choosing a step-down facility when they are ready to transition. When rates for ventilatorassociated pneumonia, catheterassociated UTIs, and central line bloodstream infections are lower than national benchmarks, the associated improved quality outcomes lead to a better overall patient and family experience.

(Bethesda Hospital reports zero cases of ventilator-associated pneumonia in calendar year 2011 and received national recognition for its ventilator weaning pathway.)

An interdisciplinary approach

Staff at LTACHs typically use an interdisciplinary approach to diagnose medical conditions, devise treatment plans, and set goals that will result in positive long-term outcomes. Physicians are integral members of these teams and are supported by nurses, many of whom have advanced training in areas such as wound, ostomy, and continence care; physician specialists and subspecialists; pharmacists; nutritionists; diabetes educators; and occupational, speech, and physical therapists. Spiritual care, creative arts therapies, and recreational therapy also may be part of a patient’s treatment plan. Caregivers partner with patients’ families to ensure that all needs are being met, that progress milestones are being achieved and that expectations are being managed.

Effective communication among LTACH staff, patients

and families, and community providers is essential to ensuring smooth transitions from one location to another. Bethesda’s interdisciplinary approach is currently being studied as a model in a University of Minnesota interprofessional experience with the next generation of health care providers. Students from the U’s medical school, pharmacy, social services, etc., who currently work in an interdisciplinary team environment are learning how to operate most effectively and how to consistently improve the delivery of care within a team vision.

Bethesda is a part of their reallife, hands-on learning lab.

Reducing the overall cost of health care

LTACHs have been shown to reduce health care costs in a number of ways. First, care provided at an LTACH costs less than care provided at a shortterm acute-care hospital ICU for appropriate patients. For patients with tracheostomies, for example, Medicare spending for LTACHS to page 38

Sioux Falls VA Health Care System “A Hospital for Heroes”

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MINNESOTA PHYSICIAN MAY 2012

Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package. They all come together at the Sioux Falls VA Health Care System.

• Orthopedic Surgeon

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To be a part of our proud tradition, contact:

Human Resources Mgmt. Service P O Box 5046 Sioux Falls SD 57117 605-333-6852

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Urgent Care We have part-time and on-call positions available at a variety of Twin Cities’ metro area HealthPartners Clinics. Evening and weekend shifts are currently available. We are seeking BC/ BE full-range 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

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MAY 2012 MINNESOTA PHYSICIAN

37

LTACHs from page 36 care has trended lower for those who used an LTACH than for those who did not.

Second, because of the interdisciplinary approach and use of innovative therapies, some patients and families do better at an LTACH than they might at a short-term acute-care hospital. Superior quality outcomes, such as lower rates of ventilator-associated pneumonia infection, also mean that patients’ length of stay is shorter and they can be transitioned to a lower-cost setting following the LTACH stay. Studies also show that many LTACH patients are more likely to be discharged to home than are individuals discharged from a short-term acute-care facility.

In addition, patients treated at LTACHs tend to be readmitted to short-term acute-care hospitals less often than patients treated in other post-acute care settings. MEDPac’s 2004 Report to Congress noted that patients using LTACHs were readmitted to short-term acute care hospitals 26 percent less often than

LTACHs provide a variety of medical and rehabilitation services that are not routinely offered at other types of post-acute facilities. patients with similar conditions who were being cared for at skilled nursing facilities.

A patient’s relatively longer length of stay at an LTACH allows the physicians who deliver patient care the gift of time to create customized care plans and develop meaningful, lasting relationships with patients and their families. This reality helps to build a strong sense of community within the LTACH and contributes to physicians’ satisfaction with their work. For example, in 2011, Bethesda Hospital had the highest physician satisfaction scores in the HealthEast Care System, which includes three STACHs. Achieving IHI’s goals

The Institute for Healthcare Improvement (IHI) has set forth the triple aims of quality outcomes, reduced costs, and increased patient satisfaction to

improve the overall health care delivery system. LTACHs have emerged as an important player in the health care continuum in terms of achieving these goals.

An LTACH is an efficient, desirable post-acute care option on the health care continuum. It provides a safety net for postICU patients, improves quality outcomes, and helps control overall total cost of care while caring for the entire family unit.

In population-based care, with employers, payers, providers, government, and consumers all asking questions and offering solutions, LTACHs have demonstrated expertise in serving a highly defined patient population.

Patients who present with precarious, complex clinical conditions have a powerful impact on the utilization of health care dollars. As the accountable care transformation

continues, providers will focus more and more on innovative models of care in the community. These may include new specialty centers, parish nurse programs, expanded home care services, etc. And the alphabet soup of post-acute care industry caregivers—SNFs, TCUs, IRFs, HHAs, and LTACHs—will be dedicated to making everything fit: appropriate, specialty patient care for the best quality outcomes and best patient experience in the most cost-effective manner after transition from an STACH. Rahul Koranne, MD, MBA, FACP, is medical director for Bethesda Hospital, HealthEast Care System Home Care and HealthEast Care Navigation Strategy. He has been active in the Department of Health and Human Services’ work around Minnesota health care reform (including payment methodology and baskets of care). Currently, he chairs the Health Care Systems Collaborative at the University of Minnesota Clinical and Translational Sciences Institute. He is board-certified in internal medicine and geriatrics.

continuing medical education Fundamental Critical Care Support 30th Annual Strategies in Primary Care Medicine Midwestern Region Burn Conference

July 19 -20, 2012 September 20-21, 2012 October 11-12, 2012

• Pre-Conference Workshops – Burn Rehabilitation: The Bridge to Recovery – The Pathway to Improving Outcomes for Pediatric Burn Injuries (includes simulation-based learning) • Post-Conference ABLS Provider Course

Optimizing Mechanical Ventilation 13th Annual Women’s Health Conference Pediatric Fundamental Critical Care Support Emergency Medicine and Trauma Update: Beyond the Golden Hour 34th Annual Cardiovascular Conference

education that measurably improves patient care 38

MINNESOTA PHYSICIAN MAY 2012

October 10, 2012

October 13, 2012

October 26-28, 2012 November 2, 2012 November 8-9, 2012 November 15, 2012 December 13-14, 2012

healthpartnersIME.com

You wouldnâ&#x20AC;&#x2122;t give a 4-year-old a drink, so why would you give one to an unborn child?

As a physician, itâ&#x20AC;&#x2122;s your responsibility to let her know: the U.S. Surgeon General Advisory says no amount of alcohol is safe during pregnancy.

Share 049: Zero Alcohol For Nine Months.

www.mofas.org