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SOCIETY PAGES
ON THE HORIZON
JOHN NELSON, MD, MHM
Celebrate HMX’s Birthday
with Mobile App
Early Mobility
Program
Continuity
Is King
PAGE 5
PAGE 21
PAGE 37
Winner of
two APEX Awards
for Healthcare
Writing
I VOLUME 19 No. 12 I DECEMBER 2015 I
AN OFFICIAL PUBLICATION OF THE SOCIETY OF HOSPITAL MEDICINE
AMA Official
Highlights EHR’s
Contribution to
Physician Burnout
By Larry Beresford
H
UNASSIGNED
AND UNDOCUMENTED
ILLUSTRATION/PAUL JUESTRICH; PHOTOS SHUTTERSTOCK.COM
PATIENTS
Inpatients lacking
insurance, a primary
care physician,
or both pose
serious challenges.
Some hospitalist
programs have
found solutions
By Karen Appold
H
ospitalists are charged with giving the best
of care and treatment, regardless of whether
or not a patient is insured or has a PCP to
transition to after discharge. But patients
who do not have insurance or a PCP pose many challenges to hospitalists, as well as the healthcare systems
they work in. Although some hospitals and health
systems have found ways to address these challenges,
issues persist, with high costs to care for these patients
topping the list. In 2013, the cost of community hospitals’
uncompensated care climbed to $46.4 billion.1
continued on page
22
MUST READS
IN THE LITERATURE
PEDIATRIC HOSPITAL MEDICINE
KEY CLINICAL QUESTION
Physician Reviews
of HM-Related
Research
Alternative Therapy for
Asthma Exacerbations in
Pediatric Inpatient Setting
Strategies for Secondary
Stroke Prevention after a
Transient Ischemic Attack
PAGE 14
PAGE 16
PAGE 17
alf of U.S. physicians are experiencing some of the symptoms of burnout, with even
higher rates for general internists. Implementation of the electronic health record (EHR) has been
cited as the biggest driver of physician job dissatisfaction, said Christine Sinsky, MD, a former hospitalist and currently vice president of
professional satisfaction at the American Medical Association (AMA), to
attendees at the 19th Management
of the Hospitalized Patient Conference, presented by the University of
California-San Francisco.1
Dr. Sinsky
deemed physician discontent
“the canary in
the coal mine”
for a dysfunctional healthcare system.
INSIDE:
After visiting
Thrombosis
Management
23 high-funcDemands
tioning mediDelicate,
Balanced
cal teams, Dr.
Approach
said
she
Sinsky
PAGE 25
had found that
70% to 80% of
For Some
physician work
Inpatients with
output could
Cirrhosis, Liver
be considered Transplant Is the
Only Cure
waste, defined
PAGE 26
as work that
doesn’t need to be done and doesn’t
add value to the patient. The AMA,
she said, has made a commitment to
addressing physicians’ dissatisfaction
and burnout.
Dr. Sinsky offered a number of
suggestions for physicians and the
larger system. Among them was the
MEETING
continued on page
25
ON THE MOVE I By Michael O’Neal
Volume 19 Number 12
December 2015
EDITORIAL STAFF
EDITOR
PHYSICIAN EDITOR
Jason Carris
jcarris@wiley.com
Danielle B. Scheurer, MD, SFHM, MSCR
scheured@musc.edu
ASSOCIATE EDITOR
PEDIATRIC EDITOR
Donna Petrozzello
dpetrozzel@wiley.com
Weijen Chang, MD, FACP, SFHM
wwch@ucsd.edu
ART DIRECTOR
COORDINATING EDITORS
Paul Juestrich
pjuestri@wiley.com
Christine Donahue, MD
The Future Hospitalist
Jonathan Pell, MD
Key Clinical Guidelines
COPY EDITOR
Kathie Christian
CONTRIBUTING WRITERS
Karen Appold, Maralyssa Ban, MD, Larry Beresford, Vanja Douglas, MD, Shakeema Edwards, Carl
S. Galloway, MD, FAAP, Kay M. Johnson, MD, Joshua Lapps, John Nelson, MD, MHM, Carol Pohlig,
BSN, RN, CPC, ACS, Justin Psaila, MD, FHM, Richard Quinn, Brett Radler, Anneliese M. Schleyer,
MD, MHA, FHM, Shobha W. Stack, MD, PhD, Lindee Strizich, MD, MSc, Win Whitcomb, MD,
MHM, Jessica S. Woan, MD, Lily Zeng, MD
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TEAM HOSPITALIST
Joshua Allen-Dicker, MD, MPH, Elizabeth A Cook, MD, Lisa Courtney, MBA, MSHA, Jasen W.
Gundersen, MD, MBA, SFHM, Sowmya Kanikkannan, MD, SFHM, Joshua LaBrin, MD, SFHM,
James W Levy PA-C, SFHM, Julianna Lindsey, MD, MBA, FHM, David M. Pressel, MD, PhD, FHM,
Monal B. Shah, MD, Amanda T. Trask, MBA, MHA, SFHM, David Weidig, MD,
Nancy K. Zeitoun, MD, FHM, Robert Zipper, MD, MMM, SFHM
THE SOCIETY OF HOSPITAL MEDICINE
Phone: 800-843-3360
Fax: 267-702-2690
Website: www.HospitalMedicine.org
Laurence Wellikson, MD, MHM, CEO
Brendon Shank, Associate Vice President, Communications
BOARD OF DIRECTORS
Robert Harrington, Jr, MD, SFHM, President
Brian Harte, MD, SFHM, President-Elect
Burke T. Kealey, MD, SFHM, Immediate Past President
Patrick Torcson, MD, MMM, SFHM, Treasurer
Danielle Scheurer, MD, MSCR, SFHM, Secretary
Nasim Afsar, MD, SFHM
Howard R. Epstein, MD, FHM
Erin Stucky Fisher, MD, MHM
Christopher Frost, MD, FHM
Jeffrey J. Glasheen, MD, SFHM
Ron Greeno, MD, MHM
Bradley Sharpe, MD, SFHM
HOW TO SUBSCRIBE
Print subscriptions are free for members of the SHM. Free access is also available online at www.the-hospitalist.org. Annual paid
subscriptions are available to all others for $154. To initiate a paid subscription, contact Wiley Subscription Services at:
Phone: 800.835.6770 (U.S. only) Email: cs-journals@wiley.com. The Hospitalist (ISSN: 1553-085X) is published monthly on
behalf of the Society of Hospital Medicine by Wiley Subscription Services, Inc., a Wiley Company, 111 River Street, Hoboken,
NJ 07030-5774. This publication is mailed periodicals rate. Postmaster, send address changes to Circulation Manager, The
Hospitalist, John Wiley & Sons, 111 River Street, 8-01, Hoboken, NJ 07030-5774. Printed in the United States by Cenveo,
Lancaster, Pa. Copyright 2015 Society of Hospital Medicine. All rights reserved. No part of this publication may be reproduced,
stored, or transmitted in any form or by any means and without the prior permission in writing from the copyright holder. All
materials published, including but not limited to original research, clinical notes, editorials, reviews, reports, letters, and book
reviews, represent the opinions and views of the authors and do not reflect any official policy or medical opinion of the institutions
with which the authors are affiliated, the Society of Hospital Medicine, or of the publisher unless this is clearly specified. Materials
published herein are intended to further general scientific research, understanding, and discussion only, and are not intended and
should not be relied upon as recommending or promoting a specific method, diagnosis, or treatment by physicians for any particular patient. While the editors, society, and publisher believe that drug selections and dosages and the specifications and usage of
equipment and devices as set forth herein are in accord with current recommendations and practices at the time of publication,
they accept no legal responsibility for any errors or omissions, and make no warranty, express or implied, with respect to material
contained herein. Publication of an advertisement or other discussions of products in this publication should not be construed as
an endorsement of the products or the manufacturers’ claims. Readers are encouraged to contact the manufacturers with any
questions about the features or limitations of the products mentioned.
To learn more about SHM’s relationship with industry partners, visit www.hospitalmedicine.org/industry.
CORRECTION
The author of the October 2015 article, “Hospitalist Practice Administrators Committee: Join SHM's
Practice Administrators‘ Mentor Program,” was misidentified. Brendon Shank, SHM’s associate vice
president for communications, authored the article.
HM MOVERS AND SHAKERS
• John Carlile, MD, is the new medical
director of pediatric hospitalist and intensivist services at Summerville (S.C.) Medical
Center. Most recently, Dr. Carlile worked
as a pediatric critical care specialist at Cox
Medical Center in Springfield, Mo.
• Bryce Gartland, MD,
FHM, has been named
CEO of Emory University Hospital in Atlanta.
Dr. Gartland currently
serves as the hospital’s
chief operating officer
and interim director of
the TEC Section of Hospital Medicine.
Dr. Gartland has practiced hospital medicine at Emory since 2005 and has served in
several leadership roles since then.
• Melissa Mattison,
MD, SFHM, has been
appointed chief of hospital medicine at Massachusetts General Hospital (MGH) in Boston.
Dr. Mattison formerly
served as the associate
chief in the section of hospital medicine at
Beth Israel Deaconess Medical Center in
Boston. In addition to her new role, she will
still teach medicine as an assistant professor
at Harvard Medical School.
• Elaine McElveen, RN, has been named
director of the hospitalist program at McLeod Medical Center Dillon in Dillon, S.C. In
her new role, McElveen also will oversee the
case management department. She has been
a practicing nurse for the McLeod Health
system for 28 years.
• Stephen Rualo, MD,
received the Standards of
Excellence Award from
Beebe Healthcare and
Beebe Medical Foundation located in Lewes,
Del. Dr. Rualo has served
as a hospitalist at Beebe
Healthcare for five years and has led the
implementation of the hospital’s electronic
medical record as the Cerner Medical Staff
Champion. The award recognizes physicians with high patient satisfaction scores,
positive patient outcomes, and overall
commitment to improving patient care.
• Christine Wentt, PA, an adult hospitalist physician assistant, has been inducted
into the VIP Woman of the Year Circle for
2015-2016 by the National Association
of Professional Women (NAPW). Wentt
works for Physicians Inpatient Care Specialists (MDICS), a private hospitalist group
in Glen Burnie, Md. Wentt also serves as
an adjunct professor in Drexel University’s
physician assistant program.
• Robert Zurcher, MD, has been appointed
chief medical officer for emergency medicine at HNI Healthcare (formerly Hospitalists Now, Inc.), based in Austin, Texas.
Dr. Zurcher comes to HNI Healthcare from
IPC Healthcare, where he served as the
administrative director for their Northwest
Region. Dr. Zurcher has 27 years of practice
experience and has founded and managed
physician services companies in both hospital medicine and emergency medicine.
BUSINESS MOVES
• North Hollywood, Calif.-based IPC
Healthcare recently announced its acquisition of Hospital Medicine Consultants,
LLC, in Elgin, Ill., a locally owned practice serving several hospitals in the Chicago
suburbs. IPC staffs hospitalist providers in
more than 400 hospitals across the country.
• The Schumacher Group, a private hospitalist and emergency medicine provider,
announced the implementation of a new
telehospitalist program at Abrom Kaplan
Memorial and Acadia General Hospitals,
both in Lafayette, La. The program will
allow physicians to provide overnight care
to the two facilities from a remote location.
The Schumacher Group was founded in
1994 and currently serves more than four
million patients per year.
• Surgical Affiliates Management Group
(SAMG), a private surgical hospitalist company based in Sacramento, Calif.,
recently contracted with Sutter Lakeside
Hospital in Lakeport, Calif. SAMG will
provide 24-hour surgicalist services to the
25-bed critical access facility in Northern
California.
IN MEMORIAM
Obafemi Abioye Ayantuga, BSc, DPhil, MBBChir, MPH,
SFHM, a senior fellow and active member of SHM, passed
away on July 23. Dr. Ayantuga was the medical director of
hospitalist services for the Fairview Medical Group, based
in Minneapolis. He practiced at Fairview Southdale Hospital in
Edina, Minn.
Dr. Ayantuga completed his PhD thesis at Oxford
University in less than three years, during which time he
received the Bishop Frazer Prize for excellence in research
in organic chemistry. Following his tenure at Oxford, Dr. Ayantuga obtained his
medical degree from Cambridge University in 1994.
As his memorial site notes, “he continued until his death, to demonstrate
dedication to quality and process involvement, illustrating commitment to active
engagement in lifelong learning.”
Mike O’Neal is a freelance writer in New York City.
www.the-hospitalist.org I DECEMBER 2015 I THE HOSPITALIST 3
FIRST PUBLISHED @ THE-HOSPITALIST.ORG
Project BOOST Study Is Journal of Hospital Medicine ’s Top-Cited Article in 2014
By Shakeema Edwards
A STUDY THAT EXAMINES
Project BOOST’s effectiveness
at decreasing rehospitalization rates is the
top-cited article from the Journal of Hospital
Medicine (JHM) in 2014.
Titled “Project BOOST: Effectiveness of
a Multihospital Effort to Reduce Rehospitalization,” the study has been cited 33 times
since its publication in July 2013. The article concludes that hospitals participating in
SHM’s Project BOOST (Better Outcomes
for Older adults through Safe Transitions)
experienced lower readmission rates.
“Project BOOST showed the effectiveness of physician-mentored implementation
at reducing rehospitalization rates by
improving the quality
of patient care,” the
study’s senior author,
Mark V. Williams,
MD, of Northwestern
University Feinberg
School of Medicine
Dr. Williams
in Chicago, writes in
an email to The Hospitalist. While researching the article, Dr.
Williams says he knew it would be especially interesting to hospitalists. “I know
4
hospitalists want to do the best job possible
and not have patients be forced to return
to the hospital because of problems with
the hospital discharge process,” he writes.
“Also, since hospitalists led this research as a
nationwide quality improvement initiative,
it is of particular interest to them.”
JHM Editor-in-Chief Andrew Auerbach, MD, MPH, and his editorial team
publish some 30% of the 40-odd submissions they receive on average each month.
“It was a very good paper,” Dr. Auerbach
says of the Project BOOST study. Because
of the importance of Project BOOST transitional care interventions, Dr. Auerbach and
his team “knew it was going to be important
to the field,” he adds.
In addition to its 33 citations, the Project
BOOST article has received significant
online attention. With an Altmetric score
of 72, it is “one of the highest-scoring articles from JHM (9 of 686),” according to its
Altmetric page. This score reflects the article’s mentions in social media, newspapers,
policy documents, and other sources.
Other factors such as the “number of
tweets and downloads, the number of times
people go to our website, those are also
things that we look at very carefully to make
sure that the journal is providing a service to
people who may not be citing the papers but
THE HOSPITALIST I DECEMBER 2015 I www.the-hospitalist.org
I think the
quality of
research
that’s
happening in the field of
hospital medicine is
improving quite a bit,
which is reflected
in the type of papers
we’re getting at
the journal.
—Andrew Auerbach, MD, MPH
who want to use it just to read and to use in
clinical care,” Dr. Auerbach says.
The four other top-cited articles discuss
reducing inpatient falls, predicting mortality
in ward patients through emergency medical
records, detecting delirium to reduce hospitalization of dementia patients, and decreasing the use of non–evidence-based theories
in treating bronchiolitis in pediatric patients.
The quality of researched published in
JHM has changed since the journal’s debut
in 2006, Dr. Auerbach says. “I think the field
has developed quite a bit,” he adds. “I think
the quality of research that’s happening in
the field of hospital medicine is improving
quite a bit, which is reflected in the type of
papers we’re getting at the journal.”
In addition to 2014’s top-cited articles, the
editorial team highlighted JHM’s new impact
factor (IF) of 2.304, up from last year’s IF of
2.081. An IF indicates how many times the
articles in a journal are cited elsewhere. “It is
a very important metric for the journal, it’s
very important for our authors, it’s important to our field,” Dr. Auerbach says. “It
talks about how important the things we’re
publishing are to other researchers.”
This increased IF ranks JHM 37 out of
153 journals in the General and Internal
Medicine category of professional, peerreviewed journals. Dr. Auerbach, whose
five-year term will end in 2016, says he
is “very happy with the pace of JHM’s]
improvement” and hopeful of the journal’s
continued success. “We’re confident in our
strategies,” he says. “I think if we keep focusing on really great papers and continue to
grow the number of papers that come to the
journal, we’ll be on track.”
SOCIETY PAGES I News and information about SHM
A New Mobile App to
Celebrate HMX’s 3rd Birthday
Happy (belated) birthday, HMX!
By Brett Radler
T
hree years ago, SHM launched Hospital
Medicine Exchange (HMX), an online
collaborative forum designed to foster
thoughtful discussions related to the hospital
medicine movement, facilitate networking
among SHM members, and house shared
resources and best practices in the field.
In celebration of this milestone, SHM has
unveiled a new native mobile app for HMX,
ensuring that SHM members have access to
insight and answers from thousands of other
members, wherever they are.
The redesigned app features a new user
interface, including easy access to your
communities as well as SHM’s website, social
media, and The Hospital Leader blog. Not
only is the new app easy to use, but, once you
are online, you can be a part of the vibrant
conversations taking place among thousands
of hospitalists across the country.
After you download the new app from the
iTunes or Google Play stores, log in using your
SHM username and password on your tablet
or smartphone to:
• Quickly scan through and engage in
discussions in your favorite communities,
including HMX Open Forum;
• Connect and network with fellow SHM
members across the country by clicking
on “People”;
• Check your private messages with Inbox;
and
• Access resources relevant to your everyday
practice in the Libraries.
Members already are responding to the new
“IT IS A GREAT APP, AND I LOVE THE
SHORTCUTS ON THE HOME SCREEN.”
—Masoumeh Ghaffari, MD, hospitalist, Piedmont Healthcare, Acworth, Ga.,
in a posting to the HMX Open Forum
and improved HMX mobile app. Hospitalist Masoumeh Ghaffari, MD of Piedmont
Healthcare in Acworth, Ga., posted in HMX
Open Forum, “It is a great app, and I love the
shortcuts on the home screen.”
The new HMX mobile app is one of
many recent HMX enhancements. HMX
is constantly growing and launching new
communities for members. For example,
the Patient Experience community and the
Women in Hospital Medicine community
were most recently launched. Join these and
other communities to share your thoughts
on topics ranging from admissions to pediatrics and everything in between.
For more information on how to get
involved and download the new app, go to
www.hmxchange.org/mobileapp.
Brett Radler is SHM’s communications coordinator.
society pages continue on page
6
WE WELCOME THE NEWEST SHM MEMBERS
A. Baptista, MD, Alabama
J. Toure, MS, Connecticut
L. Boven, Illinois L. Desmarais, DO, Maine
L. Heidemann, MD, Michigan
C. Brown, FNP, Alabama
C. Kim, DO, Delaware
N. Divakaran, Illinois S. Rajan, MD, Maine
J. Kirkpatrick, MD, Michigan P. Capote, MD, Alabama
J. Watson, PA-C, Delaware
W. Driver, APRNBC, Illinois S. Smith, NP, Maine
F. Fromm, DO, Minnesota
R. Benzar, Arizona
S. Deo, MD, Florida T. Eckert, BC, FNP, Illinois N. Goel, MD, Maryland
A. Mischel, MD, Minnesota
L. Goodman, Arizona
J. Follett, MD, Florida V. Vivek, MBBS, Illinois K. O’Connell, Maryland
B. Malhotra, MD, Mississippi
L. Harper, Arizona
A. Hils, MD, Florida R. Webster, Illinois J. Patel, MD, MBBS, Maryland
K. Berg, MD, Missouri
M. Smith, ANP, Arizona
A. Isley, MD, Florida R. Zureikat, FACP, Illinois K. Patel, Maryland
K. Heller, MD, Missouri
S. Kodali, MD, Arkansas C. Phillips, DO, Florida J. Coots, MD, Indiana
M. Platt, MD, Missouri
R. Pola, MD, Arkansas
L. Dinavahi, Georgia S. Honsuru, MD, Indiana
M. Core, California C. Edelberg, Georgia M. Shorten, MD, Indiana
A. Khaing, MD, California K. Fair, BS, Georgia C. Webster, MD, Indiana
L. Massa, California J. Fombi, MD, Georgia D. Edwards, MD, Iowa
K. Nguyen, MD, California K. Sadaria, MBBS, MD, Georgia
N. Clark, MD, Kansas
H. Rad, MD, California C. Smith, MD, Georgia A. DePorre, MD, Kansas
K. Schoenbeck, MD, California
V. Sukumar, Georgia L. Kirkpatrick, MD, Kansas
S. Slater, MD, California S. Wachtel, MD, Georgia J. Howard, NP, Kentucky
K. Martini, MD, Colorado
L. Weinberg, Georgia C. Jones, MD, Kentucky
J. Maslak, FACP, Colorado
S. Castanera, Hawaii B. Risner, MD, Kentucky
K. Mistry, Colorado
M. Barker, MD, Idaho
O. Williams, MD, Louisiana
S. James, MD, Connecticut
D. Wimer, MD, Idaho
B. Barbosa-Angles, MPH, Maine
S. Ravi, MD, Connecticut
D. Baniulis, Illinois
B. Butterfield, Maine
A. Akough-Weir, MD,
Massachusetts
E. Callahan, PA-C, Massachusetts
J. Grochowsky, ACNP,
Massachusetts
J. Lieberthal, Massachusetts
J. Lynch, Massachusetts
S. Mishra, MD, Massachusetts
A. Misri, Massachusetts
C. Morgenstein, Massachusetts
S. Ramalingam, MBBS,
Massachusetts
L. Shook-Blandin, ACNP,
Massachusetts
M. Dawaki, MD, Michigan M. Wiese, APRN, BSN, FNP,
Nebraska S. Tawney, MD, Nevada M. Hart, MD, New Hampshire
J. Lurie, MD, New Hampshire
M. Rakic, MD, New Hampshire
O. Adeoye, MBBS, New Jersey
N. Igbokwe, MD, MS, New Jersey
D. Alfandre, New York
S. Castelli, DO, New York
A. Errabelli, MBBS, New York
S. Gurram, MD, New York
continued on page
8
SOCIETY PAGES I continued from page 5
POLICY
CORNER
2015: A Major Policy Year for
Hospitalists, Hospitalized Patients
By Josh Boswell
L
aws and regulations regularly impact
hospitalists and hospitalized patients,
which is why SHM’s Advocacy
Department and Public Policy Committee
(PPC) work on behalf of SHM membership, the hospital medicine movement, and
its patients.
This year has seen significant positive
movement within several key policy areas
for all of these groups. Some of these issues
have made headlines, while others happened
under the radar, but SHM and its members
have played an important role within each
of them.
In general, observation care and related
issues have received increased attention
from lawmakers in no small part as a result
of SHM’s efforts in this area. Early in the
summer, the Centers for Medicare and
Medicaid Services (CMS) responded to
SHM’s efforts by proposing changes to
the two-midnight rule—softening yet still
retaining the rule. SHM commented posi-
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and compliance from national experts with the Society of
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program.
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cost-effective program for ongoing training and support.
CODE-H is comprised of a seven-session series of recorded
webinars let by expert faculty.
The program offers:
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• Access to an online eLearning community
• Repository of reference materials
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6
tively on the proposed changes but signaled resolution to this issue.
to both CMS and Congress that still more
Finally, passage of the Medicare Access
needs to be done to address problems inher- and CHIP Reauthorization Act (MACRA)
ent within observation policy.
in April 2015 was one of the most imporAs CMS and Congress work on a long- tant laws impacting physicians to pass in
term solution to issues related to observa- years. While it finally repealed the broken
tion stays, SHM will play an important role sustainable growth rate, its passage was just
in both proposing solutions and providing the beginning of SHM’s advocacy efforts on
the legislation.
feedback for potential changes.
MACRA will fundamentally change the
In July 2015, CMS proposed to pay
for advance care planning (ACP). This way in which physicians are compensated
proposal, assuming it is finalized at press and will accelerate the transition away from
time, is one that SHM has advocated for fee-for-service (FFS) by encouraging alterand supported for almost two years. Hospi- native payment model (APM) participation;
talists should consider it a victory. The PPC, however, many details remain unclear and
SHM members, and staff
are in need of hospihave consistently advotalist-specific clarificaIn response to
cated for improved ACP
tion. SHM has already
policies in urging Medibegun engaging with
SHM advocacy,
care to recognize the value
federal agencies and
CMS provided a
in ACP and reimburse for
lawmakers as the regulimited hardship
these critical services.
lations for MACRA are
Hospitalists have also
developed, including
exception
for
played a major part in
initiating multi-stakehospitalists in 2015 holder conversations
the advocacy efforts on
the Congressional level, and extended it into about problems facing
facility-based providers
dispelling misconcep2016. This exceptions surrounding ACP
in pay-for-performance
by educating members of
tion saved numer- programs.
SHM’s Performance
Congress and their staff
ous hospitalist
and explaining the imporMeasurement and
tance of these conversa- groups an estimated
Reporting Committions within the healthtee has been working
$2,000 to $3,000
care system. Consistent
closely with the PPC to
devise concrete proposadvocacy and hospitalist
per hospitalist
als that will allow physiinvolvement have led to a
per year.
cian/hospital alignment
positive response that has
within mandated qualbeen a long time coming.
These are just a few examples of areas in ity reporting programs, and the PPC has
which SHM has seen tangible accomplish- launched an APM workgroup that is explorments, but there are also issues that have ing the most effective avenues for hospiyet to play out and require SHM’s efforts talists to move away from FFS and take
to remain consistent in the coming years.
advantage of incentives that will be availOne of these issues is a hospitalist- able under MACRA.
Successful advocacy efforts often take
specific problem within the meaningful
use program. Hospital-based physicians are time, persistence, and most importantly,
exempt from meaningful use and associated patience; these victories demonstrate that
penalties based on their percentages of inpa- endurance pays off.
tient services; however, due to the way the
SHM is clearly making headway on behalf
law was written and changes in the health- of hospitalists and patients, and will build off
care landscape since passage, an unintended of the momentum that these victories have
consequence has arisen.
generated. As SHM Public Policy CommitHospitalists who care for significant tee chair, Ron Greeno, stated after SHM’s
numbers of “observation” and skilled nursing most recent victories, “There are times when
facility patients (coded as outpatient services) we all ask if our efforts are all worth it, and
do not qualify as hospital-based under the law the clear message that we have heard in the
and are finding themselves subject to unfair past few weeks is a resounding ‘Yes!’”
Success does take time, however, and help
penalties. In response to SHM advocacy,
CMS provided a limited hardship exception from SHM members is a critical part of the
for hospitalists in 2015 and extended it into equation. Your voice does make a difference.
To stay up to date and get involved
2016. This exception saved numerous hospitalist groups an estimated $2,000 to $3,000 with SHM’s advocacy efforts, connect
per hospitalist per year.
with SHM’s Grassroots Network at www.
The temporary exception was limited hospitalmedicine.org/grassroots, and
in scope, however, and a legislative fix is join the policy discussions in the Advocacy
needed to ensure a permanent solution. and Public Policy community on HMX at
SHM will continue to meet with legisla- connect.hospitalmedicine.org.
tors to discuss this issue and garner interest
in what we hope will result in a permanent Josh Boswell is SHM’s director of government relations.
Here’s What’s TRENDING at SHM for 2016!
By Brett Radler
READY OR NOT, 2016 is almost
here, and SHM is gearing up for
another year jam packed with exciting, enriching opportunities for
hospitalists and their teams. Here
are 10 things to have on your radar
as we head into the new year.
antibiotic prescription behaviors to prevent
antibiotic resistance. Learn how you can
be a part of the campaign, and download
the campaign posters—featuring striking
designs inspired by 1940s propaganda posters—at FightTheResistance.org.
5
2016 State of
Hospital Medicine
Survey
SHUTTERSTOCK.COM
The 2016 State of Hospital Medicine survey
will take place January through March,
with the release of the report scheduled for
September. The survey consists of comprehensive, current information crucial to
understanding the hospital medicine landscape and making better decisions in the
hospital. Visit SHM’s website to find out
how you can participate.
6
Expansion of the
Quality Improvement
Portfolio
SHM’s Center for Hospital Innovation and
Improvement continues to develop guides,
toolkits, and programs to meet the evolv-
ing needs of hospital-based clinicians and
improve the care of hospitalized patients.
New additions to the portfolio include
resources for VTE, chronic heart failure,
delirium, anemia, and end-of-life care.
7
SHM Student
Hospitalist Scholar
Grant Applications
Student members of SHM could be eligible to apply for an SHM Student Hospitalist Scholar Grant, including funding
continued on page
8
WHEN TREATING HYPERKALEMIA,
1
ARE YOU CONSTRAINED BY
Hospital Medicine
2016: March 6–9, 2016
This year’s annual meeting in San
Diego promises to be the biggest yet, with
new tracks in Co-Management/Perioperative Medicine, Health IT for Hospitalists,
and Post-Acute Care—and opportunities
to connect and collaborate with a vibrant
community of hospital medicine professionals from around the nation. Register at
hospitalmedicine2016.org before early bird
rates end on Jan. 11, 2016!
2
CURRENT OPTIONS?
Hyperkalemia is an unpredictable and life-threatening
medical emergency, and current treatments can fall short.1-4
Existing therapies for hyperkalemia present the following limitations:
■
Temporizing agents move potassium into cells
instead of removing it from the system3,5
■
Emergency hemodialysis is costly and invasive5
■
The Year of the
Hospitalist
Most current therapies are restricted to use
in the hospital, so patients are discharged
without treatment despite continued risk2,3,6
In celebration of the 20-year
anniversary of the coining of the word
“hospitalist,” SHM is preparing for a yearlong series of special events, contests, and
opportunities. Follow SHM on Twitter at
@SHMLive, and visit www.hospitalmedicine.org for the latest news!
3
Get Engaged with
Public Policy
Healthcare legislation is constantly
evolving, and hospitalists play an important
role in advocating for hospitalized patients
and the hospital medicine movement. SHM
is an active voice in many conversations
on policy development and reform. Sign
up for the Grassroots Network now to
stay updated on developments in healthcare policy, share your experiences with
healthcare programs, and even participate
in policy forums.
4
Fight the Resistance
Campaign to
Promote Antibiotic
Stewardship
References: 1. Sood MM, Sood AR, Richardson R.
Emergency management and commonly encountered
outpatient scenarios in patients with hyperkalemia. Mayo
Clin Proc. 2007;82(12):1553-1561. doi:10.1016/S00256196(11)61102-6. 2. McCullough PA, Beaver TM, BennettGuerrero E, et al. Acute and chronic cardiovascular effects
of hyperkalemia: new insights into prevention and clinical
management. Rev Cardiovasc Med. 2014;15(1):11-23.
3. Kraft MD, Btaiche IF, Sacks GS, Kudsk KA. Treatment
of electrolyte disorders in adult patients in the intensive care
unit. Am J Health Syst Pharm. 2005;62(16):1663-1682.
doi:10.2146/ajhp040300. 4. Chaaban A, Abouchacra S,
Gebran N, et al. Potassium binders in hemodialysis patients:
a friend or foe? Ren Fail. 2013;35(2):185-188. doi:10.310
9/0886022X.2012.745118. 5. Kosiborod M, Peacock WF,
Packham DK. Sodium zirconium cyclosilicate for urgent therapy
of severe hyperkalemia. N Engl J Med. 2015;372(16):1577-1578.
doi:10.1056/NEJMc1500353.444. 6. Kosiborod M, Rasmussen
HS, Lavin P, et al. Effect of sodium zirconium cyclosilicate
on potassium lowering for 28 days among outpatients with
hyperkalemia: the HARMONIZE randomized clinical trial. JAMA.
2014;312(21):2223-2233. doi:10.1001/jama.2014.15688.3.
TO LEARN MORE ABOUT
HYPERKALEMIA, VISIT
HYPERKALEMIARISKS.COM
DA-01-00041. ©2015 ZS Pharma. All rights reserved.
ZS Pharma and the ZS Pharma logo are trademarks of ZS Pharma.
SHM is partnering with the CDC to
change hospital culture and, in turn, change
SOCIETY PAGES I continued from page 7
to complete scholarly work with an active
SHM mentor in a project related to patient
safety, quality improvement, or other hospital medicine-related fields. The deadline to
apply is Feb. 15, 2016.
8
Innovative Additions
to SHM’s Digital
Learning Offerings
In addition to SHM SPARK, an MOC
preparation tool for the Focused Practice
in Hospital Medicine exam, and SHMConsults, online modules for consultative and
perioperative medicine, look for new
SHM Learning Portal activities in 2016,
like “Management of Postoperative Atrial
Fibrillation,” “Managing Pain in Postoperative Patients: What the Hospitalist Needs
to Know,” and “Perioperative Bridging of
Anticoagulant Theory.”
9
Get #SHeMpowered
on Social Media
Have a success story to share about
how SHM helped you advance your career
or enhance patient care in your hospital?
Maybe you improved your clinical skills at
the annual meeting or improved care transitions with Project BOOST? Shout it from
the rooftops—tweet @SHMLive and use
the hashtag #SHeMpowered. If you haven’t
followed SHM on Twitter, head over to @
SHMLive.
10
“Are You Number
15,000?”
of the Year of the Hospitalist. The 15,000th
member will receive an assortment of exciting prizes, including complimentary registration to Hospital Medicine 2016 in San
Diego. Know someone who is interested in
joining? Spread the word!
Brett Radler is SHM’s communications coordinator.
This is a question you want
to say “yes” to! SHM is poised to welcome
its 15,000th member in early 2016 as part
Follow SHM on Twitter at
@SHMLive, and visit
www.hospitalmedicine.org for
the latest news!
WE WELCOME THE NEWEST SHM MEMBERS I continued from page 5
V. Jasti, MD, MHA, New York
E. Wertz, North Carolina S. Kaushik, New York
P. Zimmerman, MD, North Carolina
V. Lingam, MBBS, New York
J. Donato, Ohio
A. Mandhadi, MD, New York
D. Hem, MD, Ohio
K. Perumareddi, MD, New York
P. Jain, MD, Ohio
D. Sata, DO, New York
K. Jerardi, MD, MEd, Ohio
S. Tsega, MD, New York
N. Jhala, MD, Ohio
A. Viswanathan, BS, MD, MS,
New York
C. Lee, MD, MPH, Ohio
Q. Yang, MD, DO, New York
S. Sarvepalli, MD, Ohio
A. Datta, MD, North Carolina
L. Stackhouse, ANP, APRNBC,
MSN, RN, Ohio
M. Granata, MD, North Carolina
M. Smith, PA, Oklahoma A. Halliday, North Carolina E. Carrington, PA-C, Oregon
A. Sova, DO, North Carolina S. Laies, MD, Oregon
M. Subbiah, North Carolina M. Titianu, MD, Oregon
J. Bastian, MPAS, PA-C,
Pennsylvania Z. Coward, MD, South Carolina
S. Vohra, Texas R. Khatkar, MD, South Carolina
S. Raaum, BS, MD, Utah V. Bathula, MD, Pennsylvania
N. Perkins, DO, South Carolina
C. Marcelo, MD, Virginia S. Behera, MD, MBBS,
Pennsylvania J. Balvich, MD, Tennessee
S. Odeti, MD, Virginia S. Calkins, DO, MPH,
Pennsylvania
B. Paterson, Tennessee
S. Wemple, MD, Virginia J. Sappenfield, CPA, MBA, Tennessee
L. Doyle, Washington
M. Yemane, FACP, Tennessee
B. Givens, MD, Washington
V. Ebuh, MD, MACI, Texas O. Norvell, MD, Washington
S. Galt, MD, Texas
E. Tilley, PA-C, Washington
H. Guatemala, MD, Texas
K. Espinoza, MD, Wisconsin
H. Harhara, MD, Texas J. Larkin, PA-C, Wisconsin Q. Lucas, MD, Texas G. Oosting, MD, Wisconsin S. Abraham, DO, South Carolina
T. Norris, MD, Texas
P. Brar, Wyoming G. Blackwood, CPC, COC,
South Carolina
A. Orengo, MD, Texas
R. McCuaig, CCFP, Canada
K. Rose, Texas A. Johan, Singapore
D. Jin, MD, Pennsylvania J. Lu, MD, Pennsylvania L. Petchetti, Pennsylvania M. Sathaiah, MD, Pennsylvania
T. Scanlon, NP, CRNP,
Pennsylvania
THE
FUTURE OF
LEARNING
HERE.
Looking
forONLINE
Year-End
CMEISCredits?
Look No Further. The Society of Hospital Medicine’s (SHM’s) Learning Portal is the Online
Learning Home for Hospitalists Bringing All eLearning Initiatives Together in One Location.
Stay Updated with NEW Content Including:
• shmConsults Available on SHM’s Learning Portal.
New Modules Include:
• Other new content developed for and by
hospitalists includes:
› Therapeutic Options in Coronary Artery Disease (CAD) and
Acute Coronary Syndrome (ACS)
› Ensuring Appropriate Use of Newer Anticoagulants: Acute Treatment
of Venous Thromboembolic Disease (VTE): A Virtual Patient Consult
Activity - Case 1
› Diagnosing and Managing Hyponatremia in the Hospital Setting:
Case Studies
› Perioperative Cardiac Risk Management
› Interdisciplinary Rounding at the Bedside
› Geographic Localization
› Primer for Hospitalists on Skilled Nursing Facilities
› Perioperative Management of Hyperglycemia
› And much more
Most Content is FREE to SHM Members.
Access Content and Earn CME Today at www.shmlearningportal.org.
8
BILLING AND CODING I How to get paid for your services I By Carol Pohlig, BSN, RN, CPC, ACS
ICD-10 Flexibility
Use this window to acclimate to new systems, principles, and payer policy requirements
The provider goal
for this flexibility
period is to identify
all of the “unspecified codes” used
on their claims,
review the documentation, and
determine the most
appropriate code.
E
ffective October 1, providers submit
claims with ICD-10-CM codes.
As they adapt to this new system,
physicians, clinical staff, and billers should
be relying on feedback from each other
to achieve a successful transition. On July
6, the Centers for Medicare and Medicaid Services (CMS), in conjunction with
the AMA, issued a letter to the provider
community offering ICD-10-CM guidance. The joint announcement and guidance regarding ICD-10 flexibilities minimizes the anxiety that often accompanies
change and clarifies a few key points about
claim scrutiny.1
According to the correspondence, “CMS
is releasing additional guidance that will
allow for flexibility in the claims auditing
and quality reporting process as the medical
community gains experience using the new
ICD-10 code set.”1 The guidance specifies
the flexibility that will be used during the
first 12 months of ICD-10-CM use.
This “flexibility” is an opportunity and
should not be disregarded. Physician practices
can effectively use this time to become accustomed to the ICD-10-CM system, correct
coding principles, and payer policy requirements. Internal audit and review processes
should increase in order to correct or confirm
appropriate coding and claim submission.
Valid Codes
References
1. Centers for Medicare and Medicaid Services. CMS
and AMA announce efforts to help providers get ready
for ICD-10. July 6, 2015. Available at: www.cms.gov/
Medicare/Coding/ICD10/Downloads/AMA-CMSpress-release-letterhead-07-05-15.pdf. Accessed
October 3, 2015.
2. Centers for Medicare and Medicaid Services. CMS and
AMA announce efforts to help providers get ready for
ICD-10: frequently asked questions. Available at: www.
cms.gov/Medicare/Coding/ICD10/Downloads/ICD10-guidance.pdf. Accessed October 3, 2015.
3. Centers for Medicare and Medicaid Services. Clarifying
questions and answers related to the July 6, 2015
CMS/AMA joint announcement and guidance regarding ICD-10 flexibilities. Available at: www.cms.gov/
Medicare/Coding/ICD10/Clarifying-Questions-andAnswers-Related-to-the-July-6-2015-CMS-AMAJoint-Announcement.pdf. Accessed October 3, 2015.
4. Centers for Medicare and Medicaid Services. Medicare
Learning Network: Medicare claim review programs.
May 2015. Available at: www.cms.gov/Outreach-andEducation/Medicare-Learning-Network-MLN/MLNProducts/downloads/MCRP_Booklet.pdf. Accessed
October 3, 2015.
5. Aetna. Preparation for ICD-10-CM: frequently asked
questions. Available at: www.aetna.com/healthcareprofessionals/documents-forms/preparation-for-ICD10-faqs.pdf. Accessed October 3, 2015.
6. Independence Blue Cross. Transition to ICD-10:
frequently asked questions. Available at: www.ibx.com/
pdfs/providers/claims_and_billing/icd_10/icd_10_faq.
pdf. Accessed October 3, 2015.
7. Cigna. Ready, Set, Switch: Know Your ICD-10 Codes.
Available at: http://www.cigna.com/iwov-resources/
medicare-2015/docs/icd10-chs-hcp-faq.pdf?WT.z_
nav=medicare%2Fhealthcare-professionals%2Ficd10%3BBody%3BCigna-HealthSpring%20ICD10%20Frequently%20Asked%20Questions%20
(FAQ). Accessed November 16, 2015.
Medicare review contractors are instructed
“not to deny physician or other practitioner
claims billed under the Part B physician fee
schedule through either automated medical
review or complex medical review based solely on the specificity of the ICD-10 diagnosis code as long as the physician/practitioner used a valid code from the right family.”2
This “flexibility” will only occur for the first
12 months of ICD-10-CM implementation;
the ultimate goal is for providers to assign the
correct diagnosis code and the appropriate
level of specificity after one year.
The “family code” allowance should not
be confused with provision of an incomplete
or truncated diagnosis code; these types of
codes will always result in claim denial. The
ICD-10-CM code presented on the claim
form must be carried out to the highest
character available for that particular code.
For example, an initial encounter involving
an infected peripherally inserted central catheter (PICC) is reported with ICD-10-CM
T80.212A (local infection due to central
venous catheter). An individual unfamiliar
with ICD-10-CM nomenclature may not
realize that the seventh extension character
of the code is required to carry the code out
to its highest level of specificity. If T880.212
is mistakenly reported because the encounter
detail (i.e., initial encounter [A], subsequent
encounter [D], or sequela [S]) was not documented or provided to the biller, the payers’
claim edit system will identify this as a trun-
cated or invalid diagnosis and reject the claim.
Therefore, the code is required to be complete.
The “flexibility” refers to reporting the code
that best reflects the documented condition.
As long as the reported code comes from the
same family of codes and is valid, the claim
cannot be denied.
Code Families
Code families are “codes within a category [that] are clinically related and provide
differences in capturing specific information on the type of condition.”3 Upon
review, Medicare will allow ICD-10-CM
codes from the same code family to be
reported on the claim without penalty if
the most accurate code is not selected.
For example, a patient with COPD
with acute exacerbation is admitted to
the hospital. During the 12-month “flexibility” period, the claim could include
J44.9 (COPD, unspecified) without being
considered erroneous. The most appropriate
code, however, is J44.1 (COPD with acute
exacerbation). During the course of the
hospitalization, if the physician determines
that the COPD exacerbation was caused by
an acute lower respiratory infection, J44.0
(COPD with acute lower respiratory infection) is the best option.
The provider goal for this flexibility
period is to identify all of the “unspecified codes” used on their claims, review the
documentation, and determine the most
appropriate code. The practice staff assigned
to this task would then provide feedback
to the physicians to enhance their future
reporting strategies. Although “unspecified”
codes are often reported by default, physicians and staff should attempt to reduce
usage of this code type unless the patient’s
condition is unable to be further specified or
categorized at a given point in time.
For example, it would not be acceptable
to report R10.8 (unspecified abdominal
pain) when a more specific diagnosis code
can be easily determined by patient history
or exam findings (e.g. right upper quadrant
abdominal pain, R10.11).
Affected Claims
As previously stated, “Medicare review
contractors will not deny physician or other
practitioner claims billed under the Part B
physician fee schedule through either automated medical review or complex medical
record review.”3 The review contractors
included are as follows:
• Medicare Administrative Contractors (MACs) process
claims submitted by physicians, hospitals, and other
healthcare professionals and submit payment to those
providers according to Medicare rules and regulations
(including identifying and correcting underpayments
and overpayments);
• Recovery Auditors (RACs) review claims to identify
potential underpayments and overpayments in Medicare
fee-for-service, as part of the Recovery Audit Program;
• Zone Program Integrity Contractors (ZPICs) perform
investigations that are unique and tailored to the
specific circumstances and occur only in situations
where there is potential fraud and take appropriate
corrective actions; and
• Supplemental Medical Review Contractor (SMRCs)
conduct nationwide medical review as directed by
CMS (including identifying underpayments and overpayments).4
This instruction applies to claims that
are typically selected for review due to the
ICD-10-CM code used on the claim but
does not affect claims that are selected for
review for other reasons (e.g. modifier 25
[separately identifiable visit performed
on the same day as another procedure
or service], unbundling, service-specific
current procedural terminology code). If
a claim is selected for one of these other
reasons and does not meet the corresponding criterion, the service will be denied.
This instruction also excludes claims for
services that correspond to an existing local
coverage determination (LCD) or national
coverage determination (NCD).
For example, an esophagogastroduodenoscopy (EGD) is not considered
“medically necessary” when reported with
R10.8 (unspecified abdominal pain) and
would be denied. EGD requires a more
specific diagnosis (e.g. right upper quadrant abdominal pain, R10.11) per Medicare LCD (www.mediquant.com/policy/
L35350_20151001.pdf).
Non-Medicare Payer
Considerations
Most payers that are required to convert to
ICD-10-CM have also provided some guidance about claim submission. Although most
do not address the audit and review process,
payers will follow some basic principles:
• Claims submitted with service dates on or after October
1 must use ICD-10-CM codes.
• Claims submitted with service dates prior to October
1 must use ICD-9-CM codes; this includes claims
that are initially submitted after October 1 or require
correction and resubmission after October 1.
• Physician claims will be held to medical necessity
guidelines identified by specific ICD-10-CM codes
represented in existing payer policies.
• General equivalence mappings (GEMs) should only be
used as a starting point to convert large databases and
large code lists from ICD-9 to ICD-10. Many ICD-9-CM
codes do not crosswalk directly to an ICD-10-CM code.
Physician and staff should continue to use the ICD10-CM coding books and resources to determine the
most accurate code selection.
• “Unspecified” codes are only for use when the information in the medical record is insufficient to assign a
more specific code.5,6,7
Carol Pohlig is a billing and coding expert with the University
of Pennsylvania Medical Center, Philadelphia. She is on the
faculty of SHM’s inpatient coding course.
TEAM HOSPITALIST I Q&A with our newest editorial advisory board members I By Richard Quinn
From Trainee To Trainer
Joshua LaBrin, MD, SFHM, takes pride in mentoring residents on ways to take better care of inpatients
Balancing
patient
care with
teaching
is one
of the big struggles that educators
find nowadays, and
I think you have to
get creative.
—Dr. LaBrin
F
rom 2003 to 2007, Joshua LaBrin,
MD, FACP, SFHM, completed
his residency in the University of
Pittsburgh’s internal medicine/pediatrics
program. In his chief resident year, he began
to look at fellowships.
So he started thinking about who he
considered role models in medicine.
“And they were the hospitalists,” Dr.
LaBrin says. “They were the ones on the
wards. I was able to see their compassion
for their patients, their ability to teach and
mentor residents such as myself.
“Those are the people I looked up to, and
that’s who I wanted to be.”
And with that, his career in HM began.
A fellowship in the specialty followed at the
Mayo Clinic in Rochester, Minn. Then a
teaching position there. Then one at Vanderbilt University School of Medicine in Nashville. And last year, he became an academic
hospitalist and assistant professor at the
University of Utah School of Medicine.
Now, he’s one of seven new members of
Team Hospitalist, The Hospitalist’s volunteer
editorial advisory board.
Answer: I remember my pediatrician …
putting me at ease during the visits, and
then when I was in high school and had
appendicitis and had to go through surgery.
... Each of the physicians caring for me left a
different impact and served as an inspiration
for me to follow in their footsteps. Q: What was it about those who
treated you that struck a nerve?
A: The fact that they cared for me and
were able to either keep me well or get me
better. The surgeons helped me through a
pretty scary part in my life. [They] treated me as a person, rather than just another patient, even meeting me where I was
at at that point. That was the kind of thing
that resonated with me, and I wanted to do
that for people as well.
Q: Did you have a mentor?
A: I had more than one mentor in residency and fellowship where I was able to
really learn many lessons from them. And
I think among the things that I learned,
beyond hospital medicine, was the value of
work-life balance. I’ve definitely been able
to talk with them, even beyond fellowship,
as I have moved and changed positions.
That’s something I’ve been able to reflect
on regularly. Especially as my family has
grown, I continue to communicate with
them, so I have always been grateful for
their mentorship.
Q: Have you looked to
mentor others?
A: That’s one of the things I’ve definitely
enjoyed. I have been given opportunities to
provide mentorship for new faculty or for
10
SHUTTERSTOCK.COM
Question: What got you involved
in medicine in the first place?
residents, and it’s been a humbling experience
and it’s been an honor to be able to do that. Q: In terms of personal
satisfaction, what do you enjoy
most about your job?
A: I really enjoy working with the trainees, walking with them in their development, seeing them on the wards caring for
inpatients and thinking more about issues
germane to their patients. Seeing them grow
as doctors, as physicians. That’s something I
don’t think I’ll ever get tired of doing.
Q: No job is perfect. What do you
like least about your job?
A: The most frustrating issue for me is when
you are caring for patients and you’re really
unable to provide an ideal discharge plan
for them due to a financial or technical
issue. For example, the three-midnight
rule with Medicare sometimes limits you
in what you are able to provide for your
patients ... so I think that’s probably one of
the frustrating things.
Q: What are the biggest changes
you’d like to see in the field?
A: One of the big things I have seen over
this past year is the whole MOC (Maintenance of Certification) path debate. As
nebulous as it has been for internal medicine, in general, I think it is even more so
for hospitalists. So having a kind of clear,
more practical path for hospitalists would
be one of the biggest changes I would like to
see. I think the current discussion is healthy.
I think it provides a good forum for, hopefully, some positive changes, and I hope
that also translates into positive changes
for hospitalists as well.
Q: Academic HM can be a real
time crunch, between clinical
care and classes. How do you
balance?
A: Balancing patient care with teaching is
one of the big struggles that educators find
nowadays, and I think you have to get creative. Obviously, the goal for me as an educator when I am on the wards is to help the
trainees take better care of their patients.
So the more I can find ways to be able
to provide great patient care, but do it in
a way that also either allows the residents
or students to learn to do that themselves or to be able to model that for
them, then debrief with them afterwards,
the more I can achieve that goal.
I have started to learn there are many different ways to be able to do that. And so being
able to go into the day as prepared as you
can be, and try to have a good plan in place
with also plan B and plan C, if necessary,
depending on how the day goes, I think is
what has helped me.
Richard Quinn is a freelance writer in New Jersey.
For adult patients with Staphylococcus aureus bacteremia or cSSSI caused by Staphylococcus aureus (including
methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies
equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only)
CUBICIN
®
(daptomycin for injection)
From Hospital
to Home
Included in the IDSAa guidelines as an option for initial
therapy of MRSA bacteremia (AI)1,b
CUBICIN.com
Indications: CUBICIN is indicated in adults
for the treatment of complicated skin and skin
structure infections (cSSSI) caused by susceptible
isolates of the following Gram-positive bacteria:
Staphylococcus aureus (including methicillinresistant isolates), Streptococcus pyogenes,
Streptococcus
agalactiae,
Streptococcus
dysgalactiae
subspecies
equisimilis,
and
Enterococcus faecalis (vancomycin-susceptible
isolates only).
CUBICIN is indicated in adults for the treatment
of Staphylococcus aureus bloodstream infections
(bacteremia), including those with right-sided
infective endocarditis, caused by methicillinsusceptible and methicillin-resistant isolates.
Limitations of Use: CUBICIN is not indicated for
the treatment of pneumonia.
CUBICIN is not indicated for the treatment of leftsided infective endocarditis (LIE) due to S. aureus.
CUBICIN has not been studied in patients with
prosthetic valve endocarditis.
Usage: To reduce the development of drugresistant bacteria and maintain the effectiveness
of CUBICIN and other antibacterial drugs,
CUBICIN should be used only to treat infections
that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and
susceptibility information is available, it should be
considered in selecting or modifying antibacterial
therapy. In the absence of such data, local
epidemiology and susceptibility patterns may
contribute to the empiric selection of therapy.
Empiric therapy may be initiated while awaiting
test results.
Selected Important Safety Information
Anaphylaxis/hypersensitivity reactions, which
may be life-threatening, have been reported
with CUBICIN use. If an allergic reaction occurs,
discontinue CUBICIN and treat appropriately.
Myopathy and rhabdomyolysis have been Evaluate all patients who present with diarrhea
reported with CUBICIN use. Monitor for muscle following antibacterial use. Careful medical
pain or weakness, particularly of the distal history is necessary because CDAD has been
extremities. Monitor creatine phosphokinase reported to occur more than two months after
(CPK) levels weekly and more frequently in the administration of antibacterial agents. If
patients with CPK elevations while on CUBICIN CDAD is suspected or confirmed, antibacterial
treatment and in those who received recent prior use not directed against C. difficile should be
or concomitant HMG-CoA reductase inhibitors. discontinued, if possible.
In patients with renal impairment, monitor renal Patients with persisting or relapsing S. aureus
function and CPK levels more than once weekly. bacteremia/endocarditis, possibly due to
Discontinue CUBICIN in patients with unexplained reduced daptomycin susceptibility, or poor
signs and symptoms of myopathy with CPK levels clinical response should have repeat blood
>1,000 U/L (~5× ULN), and in patients without cultures. Appropriate surgical intervention and/or
symptoms and CPK levels >2,000 U/L (≥10× ULN). change in antibacterial regimen may be required.
In addition, consider temporarily suspending Failure of treatment due to persisting or relapsing
agents associated with rhabdomyolysis, such as S. aureus bacteremia/endocarditis may be due to
HMG-CoA reductase inhibitors.
reduced daptomycin susceptibility.
Eosinophilic pneumonia has been reported with In the cSSSI and S. aureus bacteremia/endocarditis
CUBICIN use. Promptly evaluate patients who trials, decreased efficacy was observed in
develop fever, dyspnea with hypoxic respiratory CUBICIN-treated patients with moderate baseline
insufficiency, and diffuse pulmonary infiltrates and renal impairment (CrCL <50 mL/min).
discontinue CUBICIN immediately. Treatment with
systemic steroids is recommended. Recurrence Adverse Reactions: The most clinically significant
of eosinophilic pneumonia upon re-exposure has adverse reactions observed with CUBICIN 4 mg/
kg (cSSSI trials) and 6 mg/kg (S. aureus bacteremia/
been reported.
endocarditis trial) were abnormal liver function
Peripheral neuropathy has been reported with tests, elevated CPK, and dyspnea.
CUBICIN use. Monitor for signs and symptoms of
peripheral neuropathy.
Before prescribing CUBICIN, please read
Potential nervous and/or muscular system the accompanying Brief Summary on
effects in patients younger than 12 months: adjacent pages.
Avoid use of CUBICIN in patients younger than
12 months due to the risk of potential effects on aEvidence-based guidelines for the management of patients with MRSA infections,
by an expert panel, including Catherine Liu, Arnold Bayer, Sara E.
muscular, neuromuscular, and/or nervous systems prepared
Cosgrove, Robert S. Daum, Scott K. Fridkin, Rachel J. Gorwitz, Sheldon L. Kaplan,
(either peripheral and/or central) observed in Adolf W. Karchmer, Donald P. Levine, Barbara E. Murray, Michael J. Rybak, David
A. Talan, and Henry F. Chambers.
neonatal dogs.
b
The strength of recommendation and quality of evidence of CUBICIN as an option
Clostridium
difficile–associated
diarrhea for initial therapy of MRSA bacteremia are as follows:
of recommendation “A” defined as good evidence to support
(CDAD), ranging from mild diarrhea to fatal – Strength
recommendation for or against use
colitis, has been reported with nearly all systemic – Quality of evidence “I” defined as evidence from ≥1 properly randomized,
controlled trials
antibacterial
agents,
including
CUBICIN.
CrCL=creatinine clearance; HMG-CoA=3-hydroxy-3-methylglutaryl-coenzyme A; IDSA=Infectious Diseases Society of America;
MRSA=methicillin-resistant S. aureus; ULN=upper limit of normal.
Reference: 1. Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of
methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011;52(3):e18-e55.
Copyright © 2015 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
AINF-1161829-0001 10/15
Brief Summary of Prescribing Information for CUBICIN® (daptomycin for injection)
INDICATIONS AND USAGE
CUBICIN is indicated for the treatment of the following infections:
Complicated Skin and Skin Structure Infections (cSSSI) caused by susceptible isolates of the following
Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus
pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis
(vancomycin-susceptible isolates only).
Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided
Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates.
Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective
endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.
Limitations of Use: CUBICIN is not indicated for the treatment of pneumonia. CUBICIN is not indicated for
the treatment of left-sided infective endocarditis due to S. aureus. The clinical trial of CUBICIN in patients with
S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis;
outcomes in these patients were poor. CUBICIN has not been studied in patients with prosthetic valve
endocarditis.
Usage: Appropriate specimens for microbiological examination should be obtained in order to isolate and
identify the causative pathogens and to determine their susceptibility to daptomycin. To reduce the development
of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN
should be used only to treat infections that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information is available, it should be considered in selecting or
modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns
may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results.
CONTRAINDICATIONS
CUBICIN is contraindicated in patients with known hypersensitivity to daptomycin.
WARNINGS AND PRECAUTIONS
Anaphylaxis/Hypersensitivity Reactions: Anaphylaxis/hypersensitivity reactions have been reported with the
use of antibacterial agents, including CUBICIN, and may be life-threatening. If an allergic reaction to CUBICIN
occurs, discontinue the drug and institute appropriate therapy.
Myopathy and Rhabdomyolysis: Myopathy, defined as muscle aching or muscle weakness in conjunction
with increases in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal (ULN),
has been reported with the use of CUBICIN. Rhabdomyolysis, with or without acute renal failure, has been
reported. Patients receiving CUBICIN should be monitored for the development of muscle pain or weakness,
particularly of the distal extremities. In patients who receive CUBICIN, CPK levels should be monitored weekly,
and more frequently in patients who received recent prior or concomitant therapy with an HMG-CoA reductase
inhibitor or in whom elevations in CPK occur during treatment with CUBICIN. In patients with renal impairment,
both renal function and CPK should be monitored more frequently than once weekly. In Phase 1 studies and
Phase 2 clinical trials, CPK elevations appeared to be more frequent when CUBICIN was dosed more than once
daily. Therefore, CUBICIN should not be dosed more frequently than once a day. CUBICIN should be discontinued
in patients with unexplained signs and symptoms of myopathy in conjunction with CPK elevations to levels
>1,000 U/L (~5× ULN), and in patients without reported symptoms who have marked elevations in CPK, with
levels >2,000 U/L (≥10× ULN). In addition, consideration should be given to suspending agents associated with
rhabdomyolysis, such as HMG-CoA reductase inhibitors, temporarily in patients receiving CUBICIN.
Eosinophilic Pneumonia: Eosinophilic pneumonia has been reported in patients receiving CUBICIN. In reported
cases associated with CUBICIN, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and
diffuse pulmonary infiltrates. In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting
CUBICIN and improved when CUBICIN was discontinued and steroid therapy was initiated. Recurrence of
eosinophilic pneumonia upon re-exposure has been reported. Patients who develop these signs and symptoms
while receiving CUBICIN should undergo prompt medical evaluation, and CUBICIN should be discontinued
immediately. Treatment with systemic steroids is recommended.
Peripheral Neuropathy: Cases of peripheral neuropathy have been reported during the CUBICIN postmarketing
experience. Therefore, physicians should be alert to signs and symptoms of peripheral neuropathy in patients
receiving CUBICIN.
Potential Nervous System and/or Muscular System Effects in Pediatric Patients Younger than 12
Months: Avoid use of CUBICIN in pediatric patients younger than 12 months due to the risk of potential effects
on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal
dogs with intravenous daptomycin.
Clostridium difficile–Associated Diarrhea: Clostridium difficile–associated diarrhea (CDAD) has been
reported with the use of nearly all systemic antibacterial agents, including CUBICIN, and may range in severity
from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading
to overgrowth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, since these infections can
be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who
present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been
reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or
confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical
evaluation should be instituted as clinically indicated.
Persisting or Relapsing S. aureus Bacteremia/Endocarditis: Patients with persisting or relapsing
S. aureus bacteremia/endocarditis or poor clinical response should have repeat blood cultures. If a
blood culture is positive for S. aureus, minimum inhibitory concentration (MIC) susceptibility testing
of the isolate should be performed using a standardized procedure, and diagnostic evaluation of the
patient should be performed to rule out sequestered foci of infection. Appropriate surgical intervention
(e.g., debridement, removal of prosthetic devices, valve replacement surgery) and/or consideration of
a change in antibacterial regimen may be required. Failure of treatment due to persisting or relapsing
S. aureus bacteremia/endocarditis may be due to reduced daptomycin susceptibility (as evidenced by increasing
MIC of the S. aureus isolate).
Decreased Efficacy in Patients with Moderate Baseline Renal Impairment: Limited data are available
from the two Phase 3 cSSSI trials regarding clinical efficacy of CUBICIN treatment in patients with creatinine
clearance (CLCR) <50 mL/min; only 31/534 (6%) patients treated with CUBICIN in the intent-to-treat (ITT)
population had a baseline CLCR <50 mL/min.
Adjudication Committee Clinical Success Rates at Test of Cure by Baseline Creatinine Clearance
and Treatment Subgroup in the S. aureus Bacteremia/Endocarditis Trial (Population: ITT)
Success Rate n/N (%)
CUBICIN 6 mg/kg q24h
Baseline CLCR
Comparator
Bacteremia
Right-Sided
Infective
Endocarditis
Bacteremia
Right-Sided
Infective
Endocarditis
>80 mL/min
30/50 (60%)
7/14 (50%)
19/42 (45%)
5/11 (46%)
50–80 mL/min
12/26 (46%)
1/4 (25%)
13/31 (42%)
1/2 (50%)
30–<50 mL/min
2/14 (14%)
0/1 (0%)
7/17 (41%)
1/1 (100%)
Consider these data when selecting antibacterial therapy for use in patients with baseline moderate to severe
renal impairment.
Drug-Laboratory Test Interactions: Clinically relevant plasma concentrations of daptomycin have been
observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and
elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized
for the assay.
Non-Susceptible Microorganisms: The use of antibacterials may promote the overgrowth of non-susceptible
microorganisms. If superinfection occurs during therapy, appropriate measures should be taken. Prescribing
CUBICIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The following adverse reactions are described, or described in greater detail, under WARNINGS AND PRECAUTIONS:
• anaphylaxis/hypersensitivity reactions
• myopathy and rhabdomyolysis
• eosinophilic pneumonia
• peripheral neuropathy
The following adverse reaction is described in greater detail under WARNINGS AND PRECAUTIONS and DrugLaboratory Test Interactions under DRUG INTERACTIONS:
• increased INR/prolonged prothrombin time
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
Clinical Trials Experience: Clinical trials enrolled 1,864 patients treated with CUBICIN and 1,416 treated
with comparator.
Complicated Skin and Skin Structure Infection Trials In Phase 3 cSSSI trials, CUBICIN was discontinued in
15/534 (2.8%) patients due to an adverse reaction, while comparator was discontinued in 17/558 (3.0%)
patients. The rates of the most common adverse reactions, organized by body system, observed in cSSSI
(4 mg/kg CUBICIN) patients are displayed in the following table.
Incidence of Adverse Reactions that Occurred in ≥2% of Patients in the CUBICIN Treatment Group and ≥
the Comparator Treatment Group in Phase 3 cSSSI Trials
Adverse Reaction
Patients (%)
CUBICIN 4 mg/kg (N=534)
Comparator* (N=558)
5.2
4.3
Headache
5.4
5.4
Dizziness
2.2
2.0
4.3
3.8
Abnormal liver function tests
3.0
1.6
Elevated CPK
2.8
1.8
2.4
0.5
2.4
1.4
2.1
1.6
Gastrointestinal disorders
Diarrhea
Nervous system disorders
Skin/subcutaneous disorders
Rash
Diagnostic investigations
Infections
Urinary tract infections
Vascular disorders
Hypotension
Respiratory disorders
Dyspnea
*Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or
flucloxacillin; 4 to 12 g/day IV in divided doses).
Drug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of patients receiving
CUBICIN in the cSSSI trials are as follows: Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity;
Blood/Lymphatic System: leukocytosis, thrombocytopenia, thrombocytosis, eosinophilia, increased INR;
Cardiovascular System: supraventricular arrhythmia; Dermatologic System: eczema; Digestive System:
Clinical Success Rates by Renal Function and Treatment Group in Phase 3 cSSSI Trials (Population: ITT) abdominal distension, stomatitis, jaundice, increased serum lactate dehydrogenase; Metabolic/Nutritional
System: hypomagnesemia, increased serum bicarbonate, electrolyte disturbance; Musculoskeletal System:
myalgia, muscle cramps, muscle weakness, arthralgia; Nervous System: vertigo, mental status change,
Success Rate n/N (%)
paresthesia; Special Senses: taste disturbance, eye irritation.
CLCR
S. aureus Bacteremia/Endocarditis Trial In the S. aureus bacteremia/endocarditis trial, CUBICIN was discontinued
CUBICIN 4 mg/kg q24h
Comparator
in 20/120 (16.7%) patients due to an adverse reaction, while comparator was discontinued in 21/116 (18.1%)
patients. Serious Gram-negative infections (including bloodstream infections) were reported in 10/120 (8.3%)
50–70 mL/min
25/38 (66%)
30/48 (63%)
CUBICIN-treated patients and 0/115 comparator-treated patients. Comparator-treated patients received dual
therapy that included initial gentamicin for 4 days. Infections were reported during treatment and during early
30–<50 mL/min
7/15 (47%)
20/35 (57%)
and late follow-up. Gram-negative infections included cholangitis, alcoholic pancreatitis, sternal osteomyelitis/
mediastinitis, bowel infarction, recurrent Crohn’s disease, recurrent line sepsis, and recurrent urosepsis caused
In a subgroup analysis of the ITT population in the Phase 3 S. aureus bacteremia/endocarditis trial, clinical by a number of different Gram-negative bacteria. The rates of the most common adverse reactions, organized
success rates, as determined by a treatment-blinded Adjudication Committee, in the CUBICIN-treated patients by System Organ Class (SOC), observed in S. aureus bacteremia/endocarditis (6 mg/kg CUBICIN) patients are
were lower in patients with baseline CLCR <50 mL/min. A decrease of the following magnitude was not observed displayed in the following table.
in comparator-treated patients.
Incidence of Adverse Reactions that Occurred in ≥5% of Patients in the CUBICIN® (daptomycin
for injection) Treatment Group and ≥ the Comparator Treatment Group in the S. aureus
Bacteremia/Endocarditis Trial
Patients n (%)
Adverse Reaction*
CUBICIN 6 mg/kg
(N=120)
Comparator†
(N=116)
Sepsis NOS
6 (5%)
3 (3%)
Bacteremia
6 (5%)
0 (0%)
7 (6%)
4 (3%)
Chest pain
8 (7%)
7 (6%)
Edema NOS
8 (7%)
5 (4%)
10 (8%)
2 (2%)
Pruritus
7 (6%)
6 (5%)
Sweating increased
6 (5%)
0 (0%)
11 (9%)
8 (7%)
8 (7%)
1 (1%)
7 (6%)
3 (3%)
Infections and infestations
Gastrointestinal disorders
Abdominal pain NOS
General disorders and administration site conditions
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
Skin and subcutaneous tissue disorders
Psychiatric disorders
Insomnia
Investigations
Blood creatine phosphokinase increased
Vascular disorders
Hypertension NOS
* NOS, not otherwise specified.
†
Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin;
2 g IV q4h), each with initial low-dose gentamicin.
The following reactions, not included above, were reported as possibly or probably drug-related in the CUBICINtreated group: Blood and Lymphatic System Disorders: eosinophilia, lymphadenopathy, thrombocythemia,
thrombocytopenia; Cardiac Disorders: atrial fibrillation, atrial flutter, cardiac arrest; Ear and Labyrinth Disorders:
tinnitus; Eye Disorders: vision blurred; Gastrointestinal Disorders: dry mouth, epigastric discomfort, gingival
pain, hypoesthesia oral; Infections and Infestations: candidal infection NOS, vaginal candidiasis, fungemia,
oral candidiasis, urinary tract infection fungal; Investigations: blood phosphorous increased, blood alkaline
phosphatase increased, INR increased, liver function test abnormal, alanine aminotransferase increased,
aspartate aminotransferase increased, prothrombin time prolonged; Metabolism and Nutrition Disorders:
appetite decreased NOS; Musculoskeletal and Connective Tissue Disorders: myalgia; Nervous System Disorders:
dyskinesia, paresthesia; Psychiatric Disorders: hallucination NOS; Renal and Urinary Disorders: proteinuria,
renal impairment NOS; Skin and Subcutaneous Tissue Disorders: pruritus generalized, rash vesicular.
Other Trials In Phase 3 trials of community acquired pneumonia (CAP), the death rate and rates of serious
cardiorespiratory adverse events were higher in CUBICIN-treated patients than in comparator-treated patients.
These differences were due to lack of therapeutic effectiveness of CUBICIN in the treatment of CAP in patients
experiencing these adverse events.
Laboratory Changes Complicated Skin and Skin Structure Infection Trials In Phase 3 cSSSI trials of CUBICIN at a
dose of 4 mg/kg, elevations in CPK were reported as clinical adverse events in 15/534 (2.8%) CUBICIN-treated
patients, compared with 10/558 (1.8%) comparator-treated patients. Of the 534 patients treated with CUBICIN,
1 (0.2%) had symptoms of muscle pain or weakness associated with CPK elevations to greater than 4 times
the ULN. The symptoms resolved within 3 days and CPK returned to normal within 7 to 10 days after treatment
was discontinued.
Incidence of CPK Elevations from Baseline during Therapy in Either the CUBICIN Treatment Group or the
Comparator Treatment Group in Phase 3 cSSSI Trials
Patients with Normal
CPK at Baseline
All Patients
CUBICIN 4 mg/kg
(N=430)
Change in CPK
Comparator*
(N=459)
CUBICIN 4 mg/kg
(N=374)
Comparator*
(N=392)
%
n
%
n
%
n
%
n
90.7
390
91.1
418
91.2
341
91.1
357
Maximum Value >1× ULN†
9.3
40
8.9
41
8.8
33
8.9
35
>2× ULN
4.9
21
4.8
22
3.7
14
3.1
12
>4× ULN
1.4
6
1.5
7
1.1
4
1.0
4
>5× ULN
1.4
6
0.4
2
1.1
4
0.0
0
>10× ULN
0.5
2
0.2
1
0.2
1
0.0
0
No Increase
Note: Elevations in CPK observed in patients treated with CUBICIN or comparator were not clinically or statistically
significantly different.
*Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or
flucloxacillin; 4 to 12 g/day IV in divided doses).
†
ULN (Upper Limit of Normal) is defined as 200 U/L.
S. aureus Bacteremia/Endocarditis Trial In the S. aureus bacteremia/endocarditis trial, at a dose of 6 mg/kg,
11/120 (9.2%) CUBICIN-treated patients, including two patients with baseline CPK levels >500 U/L, had CPK
elevations to levels >500 U/L, compared with 1/116 (0.9%) comparator-treated patients. Of the 11 CUBICINtreated patients, 4 had prior or concomitant treatment with an HMG-CoA reductase inhibitor. Three of these 11
CUBICIN-treated patients discontinued therapy due to CPK elevation, while the one comparator-treated patient
did not discontinue therapy.
Post-Marketing Experience: The following adverse reactions have been identified during postapproval
use of CUBICIN. Because these reactions are reported voluntarily from a population of uncertain size,
it is not always possible to estimate their frequency reliably or establish a causal relationship to drug
exposure. Immune System Disorders: anaphylaxis; hypersensitivity reactions, including angioedema, drug
rash with eosinophilia and systemic symptoms (DRESS), pruritus, hives, shortness of breath, difficulty
swallowing, truncal erythema, and pulmonary eosinophilia; Infections and Infestations: Clostridium difficileassociated diarrhea; Musculoskeletal Disorders: myoglobin increased; rhabdomyolysis (some reports
involved patients treated concurrently with CUBICIN and HMG-CoA reductase inhibitors); Respiratory,
Thoracic, and Mediastinal Disorders: cough, eosinophilic pneumonia; Nervous System Disorders:
peripheral neuropathy; Skin and Subcutaneous Tissue Disorders: serious skin reactions, including
Stevens-Johnson syndrome and vesiculobullous rash (with or without mucous membrane involvement);
Gastrointestinal Disorders: nausea, vomiting; Special Senses: visual disturbances.
DRUG INTERACTIONS
HMG-CoA Reductase Inhibitors: In healthy subjects, concomitant administration of CUBICIN and simvastatin
had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy.
However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or
weakness associated with elevated levels of CPK. In the Phase 3 S. aureus bacteremia/endocarditis trial, some
patients who received prior or concomitant treatment with an HMG-CoA reductase inhibitor developed elevated
CPK. Experience with the coadministration of HMG-CoA reductase inhibitors and CUBICIN in patients is limited;
therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in
patients receiving CUBICIN.
Drug-Laboratory Test Interactions: Clinically relevant plasma concentrations of daptomycin have been
observed to cause a significant concentration-dependent false prolongation of PT and elevation of INR when
certain recombinant thromboplastin reagents are utilized for the assay. The possibility of an erroneously
elevated PT/INR result due to interaction with a recombinant thromboplastin reagent may be minimized
by drawing specimens for PT or INR testing near the time of trough plasma concentrations of daptomycin.
However, sufficient daptomycin concentrations may be present at trough to cause interaction. If confronted
with an abnormally high PT/INR result in a patient being treated with CUBICIN, it is recommended that
clinicians: 1. Repeat the assessment of PT/INR, requesting that the specimen be drawn just prior to the next
CUBICIN dose (i.e., at trough concentration). If the PT/INR value obtained at trough remains substantially
elevated above what would otherwise be expected, consider evaluating PT/INR utilizing an alternative method.
2. Evaluate for other causes of abnormally elevated PT/INR results.
USE IN SPECIFIC POPULATIONS
Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled trials of
CUBICIN in pregnant women. Embryofetal development studies performed in rats and rabbits at doses of up
to 75 mg/kg (2 and 4 times the 6 mg/kg human dose, respectively, on a body surface area basis) revealed
no evidence of harm to the fetus due to daptomycin. Because animal reproduction studies are not always
predictive of human response, CUBICIN should be used during pregnancy only if the potential benefit outweighs
the possible risk.
Nursing Mothers: Daptomycin is present in human milk but is poorly bioavailable orally. In a single case study,
CUBICIN was administered daily for 28 days to a nursing mother at an IV dose of 6.7 mg/kg/day, and samples of
the patient’s breast milk were collected over a 24-hour period on day 27. The highest measured concentration
of daptomycin in the breast milk was 0.045 mcg/mL. The calculated maximum daily CUBICIN dose to the
infant (assuming mean milk consumption of 150 mL/kg/day) was 0.1% of the maternal dose of 6.7 mg/kg/day.
Caution should be exercised when CUBICIN is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of CUBICIN in pediatric patients have not been established. Avoid
use of CUBICIN in pediatric patients younger than 12 months due to the risk of potential effects on muscular,
neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.
Geriatric Use: Of the 534 patients treated with CUBICIN in Phase 3 controlled clinical trials of cSSSI, 27% were
65 years of age or older and 12% were 75 years of age or older. Of the 120 patients treated with CUBICIN
in the Phase 3 controlled clinical trial of S. aureus bacteremia/endocarditis, 25% were 65 years of age or
older and 16% were 75 years of age or older. In Phase 3 clinical trials of cSSSI and S. aureus bacteremia/
endocarditis, clinical success rates were lower in patients ≥65 years of age than in patients <65 years of
age. In addition, treatment-emergent adverse events were more common in patients ≥65 years of age than
in patients <65 years of age. The exposure of daptomycin was higher in healthy elderly subjects than in
healthy young subjects. However, no adjustment of CUBICIN dosage is warranted for elderly patients with CLCR
≥30 mL/min.
Patients with Renal Impairment: Daptomycin is eliminated primarily by the kidneys; therefore, a modification
of CUBICIN dosage interval is recommended for patients with CLCR <30 mL/min, including patients receiving
hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). In patients with renal impairment, both renal
function and CPK should be monitored more frequently than once weekly.
OVERDOSAGE
In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Daptomycin is
cleared slowly from the body by hemodialysis (approximately 15% of the administered dose is removed over
4 hours) and by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
The use of high-flux dialysis membranes during 4 hours of hemodialysis may increase the percentage of dose
removed compared with that removed by low-flux membranes.
Before prescribing CUBICIN, please read the full Prescribing Information, available at cubicin.com.
For more detailed information, please read the Prescribing Information.
uspi-mk3009-i-1509r001
Revised 9/2015
Copyright ©2015 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved. AINF-1161829-0001 10/15
CLINICAL
IN THE
LITERATURE
ITL: Physician Reviews of
HM-Related Research
By Maralyssa Bann, MD, Kay M. Johnson, MD, Anneliese M. Schleyer, MD, MHA, FHM, Shobha W. Stack, MD, PhD,
Lindee Strizich, MD, MSc, Jessica S. Woan, MD; Hospital Medicine Program, University of Washington Medicine, Seattle
IN THIS ISSUE
1. Modified Valsalva better than standard Valsalva, p. 14.
2. Bridge less often for atrial fibrillation, p. 14.
3. CHA2DS2-Vasc score modestly predicts stroke, thromboembolism, and death
in heart failure patients, with or without Afib, p. 14.
4. Intraoperative hypotension predicts postoperative mortality, p. 14.
5. Use the Caprini Risk Assessment for critically ill surgical patients, p. 15.
6. Peer feedback improves adherence to RBC transfusion guidelines, p. 15.
7. Corticosteroids improve outcomes in community-acquired pneumonia, p. 15.
8.Standard “triple therapy” ranks lowest among 14 treatment regimens in eradication
of H. Pylori, p. 15.
9.Social isolation and polypharmacy predict medication noncompliance after discharge
in cardiac patients, p. 15.
10. Inpatient navigators reduce length of stay without increasing readmissions, p. 16.
1
Modified Valsalva Better
than Standard Valsalva
CLINICAL QUESTION: Does a
postural modification to the Valsalva
maneuver improve its effectiveness?
BACKGROUND: The Valsalva maneuver,
often used to treat supraventricular tachycardia, is rarely successful. A modification
to the maneuver to increase relaxation phase
venous return and vagal stimulation could
improve its efficacy.
STUDY DESIGN: Multicenter, randomized
controlled trial (RCT).
SETTING: Ten emergency departments in
England.
SYNOPSIS: Four hundred thirty-three
patients with stable supraventricular tachycardia (excluding atrial fibrillation or flutter) were randomized to use the Valsalva
maneuver (control) or modified Valsalva
maneuver (intervention). In the control
group, strain was standardized using a
manometer (40 mm Hg for 15 seconds).
In the intervention group, patients underwent the same maneuver, followed by lying
supine with passive leg raise to 45 degrees
for 15 seconds. Participants could repeat
the maneuver if it was initially unsuccessful. Randomization was stratified by center.
Using an intention-to-treat analysis,
43% of the intervention group achieved
the primary outcome of sinus rhythm one
minute after straining, compared with
17% of the control group (P<0.0001). The
intervention group was less likely to receive
adenosine (50% vs. 69%, P=0.0002) or
any emergency, anti-arrhythmic treatment
(80% vs. 57%, P<0.0001).
No significant differences were seen in
hospital admissions, length of ED stay, or
adverse events between groups.
14
BOTTOM LINE: In patients with stable
supraventricular tachycardia, modifying
the Valsalva maneuver is significantly more
effective in restoring sinus rhythm.
CITATION: Appelboam A, Reuben A, Mann
C, et al. Postural modification to the standard Valsalva manoeuvre for emergency
treatment of supraventricular tachycardias
(REVERT): a randomised controlled trial
[published online ahead of print August
24, 2015]. Lancet. doi: 10.1016/S01406736(15)61485-4.
2
Bridge Less Often for
Atrial Fibrillation
CLINICAL QUESTION: In patients
with atrial fibrillation (AF) or flutter, is
heparin bridging needed during interruption of warfarin therapy for surgery or invasive procedures?
BACKGROUND: Bridging is intended to
decrease the risk of stroke or other arterial
thromboembolism by minimizing time
off anticoagulation. Bridging may increase
the risk of serious bleeding, offsetting any
benefit. Guidelines have provided weak and
inconsistent recommendations due to a lack
of randomized trials.
STUDY DESIGN: Randomized, double
blind, placebo-controlled trial.
SETTING: More than 100 centers in the
U.S. and Canada, from 2009-2014.
SYNOPSIS: Investigators randomized
1,884 patients on warfarin with a CHADS2
risk factor of one or higher undergoing
elective surgery or procedure to dalteparin or placebo, from three days to 24 hours
before the procedure and for five to 10 days
after. Mean CHADS2 score was 2.3; 3% of
patients had scores of five to six. Approximately one-third of patients were on aspi-
rin, and most procedures (89%) were classified as minor. Patients with mechanical
heart valves, stroke/transient ischemic
attack (TIA)/systemic embolization within
12 weeks, major bleeding within six weeks,
renal insufficiency, thrombocytopenia or
planned cardiac, intracranial, or intraspinal surgery were excluded.
Thirty-day incidence of arterial thromboembolism (stroke, TIA, systemic embolization) was 0.4% in the non-bridging group
and 0.3% in the bridging group (P=0.01
for noninferiority). Patients suffering arterial thromboembolism had mean CHADS2
scores of 2.6; most events occurred after
minor procedures. Major bleeding was less
common with no bridge (1.3% vs. 3.2%,
relative risk 0.41, P=0.005 for superiority).
In this trial, most patients underwent
minor procedures and few CHADS2 5-6
patients were enrolled; however, this welldesigned, randomized trial adds important
evidence to existing observational data.
BOTTOM LINE: Bridging is not warranted
for most AF patients with CHADS2 scores
of four or lower, at least for low-risk procedures.
CITATION: Douketis JD, Spyropoulos AC,
Kaatz S, et al. Perioperative bridging anticoagulation in patients with atrial fibrillation.
N Engl J Med. 2015;373(9):823-833.
3
CHA2DS2-Vasc Score
Modestly Predicts Stroke,
Thromboembolism, Death
among Patients with Heart
Failure, with or without Afib
CLINICAL QUESTION: For patients with
heart failure (HF), with and without
concurrent Afib (AF), does the CHA2DS2VASc score predict ischemic stroke, thromboembolism, and death?
BACKGROUND: Factors in the CHA2DS2VASc score predict increased risk of stroke,
thromboembolism, and death, regardless
of whether AF is present. It is unknown if
this score can identify subgroups of patients
with HF, with and without AF, at particularly high or low risk of these events.
STUDY DESIGN: Prospective, cohort study.
SETTING: Three Danish registries, 20002012.
SYNOPSIS: Among 42,987 patients 50
years and older with incident HF not on
anticoagulation, the absolute risk of stroke
among patients without AF was 1.5% per
year or higher with a CHA2DS2-VASc
score of two or higher. The absolute risk of
stroke was 4% or higher at five years. Risks
were higher in the 21.9% of patients with
AF. The CHA2DS2-VASc score modestly
predicted endpoints and had an approximately 90% negative predictive value for
stroke, thromboembolism, and death at
one-year follow-up, regardless of whether
or not AF was present.
In this large study, HF patients in a nondiverse population were studied, and some
patients may have had undiagnosed AF.
Functional status and ejection fraction in
patients with HF could not be categorized;
however, reported five-year results may be
generalizable to patients with chronic HF.
Select patients with HF without AF, who
have two or more factors of the score besides
HF, might benefit from anticoagulation.
BOTTOM LINE: The CHA2DS2-VASc score
modestly predicts stroke, thromboembolism, and death among patients with HF,
but further studies are needed to determine
its clinical usefulness.
CITATION: Melgaard L, Gorst-Rasmussen
A, Lane DA, Rasmussen LH, Larsen TB,
Lip GY. Assessment of the CHA2DS2-VASc
Score in predicting ischemic stroke, thromboembolism, and death in patients with
heart failure with and without atrial fibrillation. JAMA. 2015;314(10):1030-1038.
4
Intraoperative
Hypotension Predicts
Postoperative Mortality
CLINICAL QUESTION: What blood pressure deviations during surgery are predictive
of mortality?
BACKGROUND: Despite the widely
assumed importance of blood pressure (BP)
management on postoperative outcomes,
there are no accepted thresholds requiring
intervention.
STUDY DESIGN: Retrospective cohort.
SETTING: Six Veterans’ Affairs hospitals,
2001-2008.
SYNOPSIS: Intraoperative BP data from
18,756 patients undergoing major noncardiac surgery were linked with procedure,
patient-related risk factors, and 30-day
mortality data from the VA Surgical Quality Improvement Program database. Overall 30-day mortality was 1.8%. Using three
different methods for defining hyper- or
hypotension (based on standard deviations
from the mean in this population, absolute
thresholds suggested by medical literature,
or by changes from baseline BP), no measure of hypertension predicted mortality;
however, after adjusting for 10 preoperative patient-related risk factors, extremely
low BP for five minutes or more (whether
defined as systolic BP <70 mmHg, mean
arterial pressure <49 mmHg, or diastolic
BP <30 mmHg) was associated with 30-day
mortality, with statistically significant odds
ratios in the 2.4-3.2 range.
Because this is an observational study,
no causal relationship can be established
from these data. Low BPs could be markers
for sicker patients with increased mortality, despite researchers’ efforts to adjust for
known preoperative risks.
BOTTOM LINE: Intraoperative hypotension
lasting five minutes or more, but not intraoperative hypertension, predicts 30-day
mortality.
CITATION: Monk TG, Bronsert MR,
Henderson WG, et al. Association between
intraoperative hypotension and hypertension and 30-day postoperative mortality
in noncardiac surgery. Anesthesiology.
2015;123(2):307-319.
5
Use Caprini Risk
Assessment for Critically
Ill Surgical Patients
CLINICAL QUESTION: Is the Caprini Risk
Assessment Model for VTE risk valid in
critically ill surgical patients?
BACKGROUND: Critically ill surgical
patients are at increased risk of developing
VTE. Chemoprophylaxis decreases VTE
risk, but benefits must be balanced against
bleeding risk. Rapid and accurate risk stratification supports decisions about prophylaxis; however, data regarding appropriate
risk stratification are limited.
STUDY DESIGN: Retrospective, cohort study.
SETTING: Surgical ICU (SICU) at a single,
U.S. academic medical center, 2007-2013.
SYNOPSIS: Among 4,844 consecutive
admissions, the in-hospital VTE rate was
7.5% (364). Using a previously validated,
computer-generated, retrospective risk score
based on the 2005 Caprini model, patients
were most commonly at moderate risk for
VTE upon ICU admission (32%). Fifteen
percent (723) were extremely high risk. VTE
incidence increased linearly with increasing
Caprini scores. Data were abstracted from
multiple electronic sources.
Younger age, recent sepsis or pneumonia, central venous access on ICU admission, personal VTE history, and operative
procedure were significantly associated
with inpatient VTE events. The proportion of patients who received chemoprophylaxis postoperatively was similar
regardless of VTE risk. Patients at higher
risk were more likely to receive chemoprophylaxis preoperatively.
Results from this retrospective, singlecenter study suggest that Caprini is a valid
tool to predict inpatient VTE risk in this
population. Inclusion of multiple risk
factors may make calculation of this score
prohibitive in other settings unless it can be
computer generated.
BOTTOM LINE: Caprini risk scores accurately distinguish critically ill surgical
patients at high risk of VTE from those at
lower risk.
CITATION: Obi AT, Pannucci CJ, Nackashi
A, et al. Validation of the Caprini venous
thromboembolism risk assessment model
in critically ill surgical patients. JAMA Surg.
2015;150(10):941-948. doi:10.1001/jamasurg.2015.1841.
6
Peer Feedback Improves
Adherence to RBC
Transfusion Guidelines
CLINICAL QUESTION: Can a multifaceted
approach involving clinician education,
peer email feedback, and monthly audit
SHORT TAKES
PATIENT FINANCIAL RESPONSIBILITY FOR OBSERVATION CARE
Analysis of 2010-2012 Medicare data shows that mean out-of-pocket cost for observation
stays was $469, significantly less than inpatient deductibles ($1,100.00, P<0.01); 9% cost
more. Complex care and multiple-observation stays increased financial responsibility.
CITATION: Kangovi S, Cafardi SG, Smith RA, Kulkarni R, Grande D. Patient financial responsibility for observation care. J Hosp Med. 2015;10(11):718-723. doi: 10.1002/jhm.2436.
DON’T PAUSE COMPRESSIONS
This observational trial involving 319 patients shows that interrupting chest compressions for
any duration, at any time during resuscitation in out-of-hospital cardiac arrest, reduces survival
(odds ratios 0.83-0.89).
CITATION: Brouwer TF, Walker RG, Chapman FW, Koster RW. Association between chest
compression interruptions and clinical outcomes of ventricular fibrillation out-of-hospital cardiac
arrest. Circulation. 2015;132(11):1030-1037.
EPIDURAL STEROIDS NOT HELPFUL FOR RADICULOPATHY
AND SPINAL STENOSIS
In this systematic review and meta-analysis of 38 English-language randomized trials, epidural
corticosteroid injections for radiculopathy and spinal stenosis were associated with small,
immediate improvements in pain, function, and surgery risk; benefits were not sustained.
CITATION: Chou R, Hashimoto R, Friedly J, et al. Epidural corticosteroid injections for
radiculopathy and spinal stenosis: a systematic review and meta-analysis. Ann Intern
Med. 2015;163(5):373-381.
DPP-4 INHIBITORS FOR TYPE 2 DIABETES MAY CAUSE SEVERE JOINT PAIN
In August 2015, the FDA released a warning regarding the potential side effect of severe
arthralgias cause by DPP-4 inhibitors such as sitagliptin, saxagliptin, linagliptin, and alogliptin.
CITATION: U.S. Food and Drug Administration. DPP-4 inhibitors for type 2 diabetes: drug
safety communication – may cause severe joint pain. Aug 28, 2015. Available at: http://
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/
ucm460238.htm. Accessed November 5, 2015.
data improve adherence to restrictive red
blood cell (RBC) transfusion guidelines?
BACKGROUND: Randomized controlled
trials and professional society guidelines
support adoption of RBC transfusion strategies in stable, low-risk patients. Studies
suggest that education and feedback from
specialists may decrease inappropriate transfusion practices, but peer-to-peer feedback
has not yet been explored.
STUDY DESIGN: Prospective, interventional study.
SETTING: Tertiary care center SICU, single
U.S. academic center.
SYNOPSIS: All stable, low-risk SICU
patients receiving RBC transfusions
were included in this study. Intervention
consisted of educational lectures to clinicians, dissemination of monthly aggregate
audit transfusion data, and direct email
feedback from a colleague to clinicians
ordering transfusions outside of guidelines. Six-month intervention data were
compared with six months of pre-intervention data.
During the intervention, total transfusions decreased by 36%, from 284 units to
181 units, and percentage of transfusions
outside restrictive guidelines decreased
to 2% from 25% (P<0.001). Six months
after the end of the intervention period,
transfusions outside restrictive guidelines
increased back to 17%, suggesting a lack of
permanent change in transfusion practices.
BOTTOM LINE: A multifaceted approach
involving education, peer-to-peer feedback,
and monthly audits improved adherence
to restrictive RBC transfusion guidelines;
however, changes were not sustained.
CITATION: Yeh DD, Naraghi L, Larentzakis A, et al. Peer-to-peer physician feedback improves adherence to blood transfusion guidelines in the surgical intensive
care unit. J Trauma Acute Care Surg.
2015;79(1):65-70.
7
Corticosteroids Improve
Outcomes in CommunityAcquired Pneumonia
CLINICAL QUESTION: Are adjunctive
corticosteroids beneficial for patients hospitalized with community-acquired pneumonia (CAP)?
BACKGROUND: Numerous studies have
tried to determine whether or not adjunctive corticosteroids for CAP treatment in
hospitalized patients improve outcomes.
Although recent trials have suggested that
corticosteroids may improve morbidity and
mortality, prior meta-analyses have failed to
show a benefit, and steroids are not currently
routinely recommended for this population.
STUDY DESIGN: Systematic review and
meta-analysis of 13 RCTs, predominantly
from Europe.
SYNOPSIS: Analysis of 1,974 patients
suggested a decrease in all-cause mortality
(relative risk (RR) 0.67, 95% CI 0.45-1.01)
with adjunctive corticosteroids. Subgroup
analysis for severe CAP (six studies, n=388)
suggested a greater mortality benefit (RR
0.39, 95% CI 0.2-0.77). There was a
decrease in the risk of mechanical ventilation (five studies, n=1060, RR 0.45, CI,
0.26-0.79), ICU admission (three studies,
n=950, RR 0.69, 95% CI, 0.46-1.03), and
development of acute respiratory distress
syndrome (four studies, n=945, RR 0.24,
95% CI 0.10-0.56).
Both hospital length of stay (LOS) and
time to clinical stability (hemodynamically
stable with no hypoxia) were significantly
decreased (mean decrease LOS one day;
time to clinical stability 1.22 days). Adverse
effects were rare but included increased
rates of hyperglycemia requiring treatment
(RR 1.49, 95% CI 1.01-2.19). There was
no increased frequency of gastrointestinal
hemorrhage, neuropsychiatric complications, or rehospitalization. BOTTOM LINE: Adjunctive corticoster-
oids for inpatient CAP treatment decrease
morbidity and mortality, particularly in
severe disease, and decrease LOS and time to
clinical stability with few adverse reactions.
CITATION: Siemieniuk RA, Meade MO,
Alonso-Coello P, et al. Corticosteroid therapy for patients hospitalized with community-acquired pneumonia: a systematic
review and meta-analysis. Ann Intern Med.
2015;163(7):519-528.
8
Standard “Triple Therapy”
Ranks Lowest among 14
Treatment Regimens in
Eradication of H. Pylori
CLINICAL QUESTION: How do current
Helicobacter pylori treatments compare in
efficacy and tolerance?
BACKGROUND: Efficacy of standard
“triple therapy” for H. pylori (proton pump
inhibitor plus clarithromycin and amoxicillin or metronidazole) is declining due to the
development of antibiotic resistance. Different medication combinations and/or time
courses are currently used, but comparative
effectiveness of these treatments has not
been evaluated comprehensively.
STUDY DESIGN: Systematic review and
network meta-analysis.
SETTING: Cochrane Library, PubMed, and
Embase databases.
SYNOPSIS: One hundred forty-three
RCTs evaluating a total of 14 treatments
for H. pylori were identified. Network metaanalysis was performed to rank order treatments for efficacy (eradication rate of H.
pylori) and tolerance (adverse event occurrence rate). Seven days of “concomitant
treatment” (proton pump inhibitor plus
three antibiotics) ranked the highest in
efficacy (eradication rate 0.94; 95% confidence interval [CI] 0.89-0.98), though this
treatment group comprised a very small
proportion of overall participants and studies and may be subject to bias. Seven days of
standard “triple therapy” ranked the lowest
in efficacy (eradication rate 0.73; 95% CI
0.71-0.75).
Of note, subgroup analysis showed variation in efficacy rankings by geographic
location, suggesting that findings may not
be universally applicable. Only two treatments showed significantly different adverse
event occurrence rates compared to standard
“triple therapy,” indicating overall similar
tolerance for most treatments.
BOTTOM LINE: Several treatment regimens may be more effective than standard
H. pylori “triple therapy” and equally well
tolerated.
CITATION: Li BZ, Threapleton DE, Wang
JY, et al. Comparative effectiveness and
tolerance of treatments for Helicobacter
pylori: systematic review and network metaanalysis. BMJ. 2015;351:h4052.
9
Social Isolation,
Polypharmacy
Predict Medication
Noncompliance Post-Discharge
in Cardiac Patients
CLINICAL QUESTION: What are predictors of primary medication nonadherence
after discharge?
BACKGROUND: Primary nonadherence
occurs when a patient receives a prescripcontinued on page
16
IN THE LITERATURE I continued from page 15
tion at hospital discharge but does not fill
it. Predictors of post-discharge primary
nonadherence could serve as useful targets
to guide adherence interventions.
STUDY DESIGN: RCT, secondary analysis.
SETTING: Two tertiary care, U.S. academic
hospitals.
SYNOPSIS: Using the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) study database,
investigators conducted a secondary analysis of adults hospitalized for acute coronary
syndrome or acute decompensated heart
failure who received pharmacist-assisted medication reconciliation, discharge
counseling, low-literacy adherence aids,
and a follow-up phone call. The prevalence of primary nonadherence one to four
days post-discharge was 9.4% among 341
patients. In subsequent multivariate analysis, significant factors for noncompliance
were living alone (odds ratio 2.2, 95% CI
1.01-4.8, P=0.047) and more than 10 total
discharge medications (odds ratio 2.3, 95%
CI 1.05-4.98, P=0.036).
Limitations to this study include biases
from patient-reported outcomes, lack of
patient copayment data, and limited characterization of discharge medication type.
BOTTOM LINE: Among patients hospitalized for cardiac events, social isolation and
polypharmacy predict primary medication
nonadherence to discharge medications
despite intensive pharmacist counseling.
CITATION: Wooldridge K, Schnipper JL,
Goggins K, Dittus RS, Kripalani S. Refractory primary medication nonadherence:
prevalence and predictors after pharmacist
counseling at hospital discharge [published
online ahead of print August 21, 2015]. J
Hosp Med. doi: 10.1002/jhm.2446.
10
Inpatient Navigators
Reduce Length of
Stay without
Increasing Readmissions
PEDIATRIC HM LITERATURE I
CLINICAL QUESTION: Does a patient
navigator (PN) who facilitates communication between patients and providers
impact hospital length of stay (LOS) and
readmissions?
BACKGROUND: Increasing complexity of
hospitalization challenges the safety of care transitions. There are few studies about the effectiveness of innovations targeting both communication and transitional care planning.
STUDY DESIGN: Retrospective, cohort study.
SETTING: Single academic health center in
Canada, 2010-2014.
SYNOPSIS: PNs, dedicated team-based
facilitators not responsible for clinical
care, served as liaisons between patients
and providers on general medicine teams.
They rounded with medical teams, tracked
action items, expedited tests and consults,
and proactively served as direct primary
contacts for patients/families during and
after hospitalization. PNs had no specified
prior training; they underwent on-the-job
training with regular feedback.
Researchers matched 7,841 hospitalizations (5,628 with PN; 2,213 without) by
case mix, age, and resource intensity. LOS
and 30-day readmissions were primary
outcomes. Hospitalizations with PNs were
21% shorter (1.3 days; 6.2 v 7.5 days,
P<0.001) than those without PNs.
There were no differences in 30-day
readmission rates (13.1 v 13.8%, P=0.48).
In this single center study in Canada, the
impact of PN salaries (the only program
cost) relative to savings is unknown.
BOTTOM LINE: Inpatient navigators
streamline communication and decrease
LOS without increasing readmissions.
Additional cost-benefit analyses are needed.
CITATION: Kwan JL, Morgan MW, Stewart TE, Bell CM. Impact of an innovative
patient navigator program on length of stay
and 30-day readmission [published online
ahead of print August 10, 2015]. J Hosp
Med. doi: 10.1002/jhm.2442.
By Carl S. Galloway, MD, FAAP
Alternative Therapy for Asthma
Exacerbations in Pediatric Inpatient Setting
Dr. Galloway is a pediatric
hospitalist at Sanford Children’s
Hospital in Sioux Falls,
S.D., assistant professor of
pediatrics at the University of
South Dakota Sanford School
of Medicine, and vice chief
of the division of hospital
pediatrics at USD SSOM and
Sanford Children’s Hospital.
CLINICAL QUESTION: In
children hospitalized in a non-ICU
setting with asthma exacerbation,
how effective is dexamethasone
compared to prednisone/
prednisolone?
BACKGROUND: Asthma
is the second most common
reason for hospital admission in
childhood.1 National guidelines
recommend treatment with
systemic corticosteroids in
addition to beta-agonists.2
Traditionally, prednisone/
prednisolone has been used
for asthma exacerbations, but
multiple recent studies in ED
settings have shown equal
efficacy with dexamethasone for
mild to moderate exacerbations.
Benefits of dexamethasone use
include a longer half-life (so single
dose or two-day courses can be
used), good enteral absorption,
general palatability, less emesis,
and better adherence. To this
point, no studies have compared
dexamethasone with prednisone/
prednisolone therapy in
hospitalized children.
STUDY DESIGN: Multicenter,
retrospective cohort study.
SETTING: Freestanding, tertiary
care children’s hospitals.
SYNOPSIS: The authors used
the PHIS (Pediatric Health
Information System) database,
which includes clinical and billing
data from 42 children’s hospitals,
to compare children who received
dexamethasone to those who
were treated with prednisone/
prednisolone therapy for asthma
16
exacerbations in the inpatient
setting. Patients were included if
they were aged four to 17 years,
were hospitalized between January
2007 and December 2012 with
ICD-9 code for a principal diagnosis
of asthma, and received either
dexamethasone or prednisone/
prednisolone.
Exclusion criteria included:
• Management in the ICU at the
time of admission;
• All patient refined diagnosis
related groups (APR-DRG)
severity level moderate or
extreme;
• Complex chronic conditions;
• Secondary diagnosis other
than asthma requiring steroids,
or treatment with racemic
epinephrine;
• Only the first admission
was included out of multiple
hospitalizations within a 30-day
period; and/or
• Patient was treated with
both dexamethasone and
prednisone/prednisolone.
The primary outcome evaluated
was length of stay (LOS);
secondary outcomes included
readmissions, cost, and transfer
to ICU during hospitalization. The
authors compared the overall groups,
then performed 1:1 propensity
score matching to address residual
confounding; this statistical
technique closely matches patient
characteristics between cohorts.
Overall, there were 40,257
hospitalizations, with 1,166 children
(2.9%) receiving dexamethasone
Costs were lower for
the dexamethasone
group, both for the
index admission and
for episode admission (defined as index
admission plus sevenday readmissions).
There was no difference in readmissions
between the groups,
and no patients in
this cohort were transferred to the ICU.
and 39,091 (97.1%) receiving
prednisone/prednisolone. The use
of dexamethasone varied greatly
between hospitals (35/42 hospitals
used dexamethasone, with rates
ranging from 0.047% to 77.4%).
In the post-match cohort, 1,284
patients were evaluated, 642 in each
group. In this cohort, patients with
dexamethasone had significantly
shorter LOS (67.4% had LOS
less than one day vs. 59.5% in the
prednisone/prednisolone group;
6.7% of dexamethasone patients
had LOS of more than three days
vs. 12% of prednisone/prednisolone
patients). Costs were lower for
the dexamethasone group, both
for the index admission and for
episode admission (defined as
index admission plus seven-day
readmissions). There was no
difference in readmissions between
the groups, and no patients in this
cohort were transferred to the ICU.
There are several limitations to
this study. Dexamethasone use
varied widely among participating
hospitals. The data source did not
permit access to dosing, duration,
or compliance with therapy and
could not compare albuterol use
between groups. The findings
may not be generalizable to all
populations, because it excluded
patients with high severity and
medical complexity and only
evaluated tertiary care children’s
hospitals.
BOTTOM LINE: Dexamethasone
is a potential alternative therapy
for asthma exacerbations in
the inpatient setting. Further
studies are needed to evaluate
effectiveness, including dosing,
frequency, and duration.
CITATION: Parikh K, Hall M,
Mittal V, et al. Comparative
effectiveness of dexamethasone
versus prednisone in children
hospitalized with asthma. J Pediatr.
2015;167(3):639-644.
References
1. Yu H, Wier LM, Elixhauser A. Hospital
stays for children, 2009. HCUP statistical brief #118. Agency for Healthcare
Research and Quality. August 2011.
Available at: http://hcup-us.ahrq.gov/
reports/statbriefs/sb118.pdf. Accessed
November 1, 2015.
2. National Heart, Lung, and Blood Institute.
National Asthma Education and Prevention Program expert panel report 3
(EPR-3): guidelines for the diagnosis and
management of asthma–Summary Report 2007. Available at: http://www.nhlbi.
nih.gov/health-pro/guidelines/current/
asthma-guidelines/summary-report-2007.
Accessed November 1, 2015.
CLINICAL
KEY CLINICAL QUESTION
What Are the Strategies for
Secondary Stroke Prevention
after Transient Ischemic Attack?
By Lily Zeng, MD, Vanderbilt University Medical Center in Nashville, Tenn., and Vanja Douglas, MD; University of California
at San Francisco
KEY POINTS
• TIAs usually last less than one
hour but are considered warning
signs for strokes; secondary
prevention is key.
• Advances in neuroimaging are
beginning to blur the classic definition of TIAs; diffusion-weighted
imaging is able to detect acute
infarcts in patients who present
with symptoms matching the
classic definition of TIAs.
• ABCD2 score works as a triage
tool: A score of three or higher
warrants a hospital admission.
Incorporating imaging data
increases the discriminatory
power of stroke prediction.
• Antiplatelet therapy should be
initiated immediately. Blood
pressure should be lower than
140/90 mm Hg at the time of
discharge in a non-diabetic.
Statins can be initiated in the
hospital with an LDL goal of 100.
Empiric atorvastatin 80 mg is an
alternative approach. Diabetes
control is less stringent per
American Diabetes Association
guidelines.
• Encourage smoking cessation,
exercise, and avoidance of
heavy alcohol use. Consider
referral for sleep study to evaluate for undiagnosed obstructive
sleep apnea.
Case
Mr. G is an 80-year-old man with a pacemaker, peripheral artery disease, atrial fibrillation
(AF) on warfarin, and tachy-brady syndrome.
He presented after experiencing episodes in
which he was unable to speak and had weakness on his right side. He had a normal neurological exam upon arrival to the ED, and his
blood pressure was 160/80 mm Hg.
Overview
Transient ischemic attacks (TIAs) are brief
interruptions in brain perfusion that do not
result in permanent neurologic damage. Up
to half a million TIAs occur each year in
the U.S., and they account for one third
of acute cerebrovascular disease.1 While the
term suggests that TIAs are benign, they
are in fact an important warning sign of
impending stroke and are essentially analogous to unstable angina. Some 10% of
TIAs convert to full strokes within 90 days,
but growing evidence suggests appropriate
interventions can decrease this risk to 3%.2
Unfortunately, the symptoms of TIA have
usually resolved by the time patients arrive
at the hospital, which makes them challenging to diagnose. This article provides
a summary of how to diagnose TIA accurately, using a focused history informed by
cerebrovascular localization; how to triage,
evaluate, and risk stratify patients; and how
to implement preventative strategies.
Review of the Data
Classically, TIAs are defined as lasting less
than 24 hours; however, 24 hours is an arbitrary number, and most TIAs last less than
one hour.1 Furthermore, this definition
has evolved with advances in neuroimaging that reveal that up to 50% of classically
defined TIAs have evidence of infarct on
MRI.1 There is no absolute temporal cut-off
after which infarct is always seen on MRI,
but longer duration of symptoms correlates with a higher likelihood of infarct.
To reconcile these observations, a recently
proposed definition stipulates that a true
TIA lasts no more than one hour and does
not show evidence of infarct on MRI.3
The causes of TIA are identical to those for
ischemic stroke. Cerebral ischemia can result
from an embolus, arterial thrombosis, or
hypoperfusion due to arterial stenosis. Emboli
can be cardiac, most commonly due to AF,
or non-cardiac, stemming from a ruptured
atherosclerotic plaque in the aortic arch, the
carotid or vertebral artery, or an intracranial
vessel. Atherosclerotic disease in the carotid
arteries or intracranial vessels can also lead to
thrombosis and occlusion or flow-related
TIAs as a result of severe stenosis.
cerebral artery (MCA) ischemia causes
contralateral face and arm weakness out
of proportion to leg weakness. Ischemia in
Broca’s area of the brain, which is supplied
by the left MCA, may also cause expressive
aphasia. Transient monocular blindness is
a TIA of the retina due to atheroemboli
originating from the internal carotid artery.
Vertebrobasilar TIA is less common than
anterior circulation TIA and manifests with
brainstem symptoms that include diplopia,
dysarthria, dysphagia, vertigo, gait imbalance, and weakness. In general, language
and motor symptoms are more specific for
cerebral ischemia and therefore more worrisome for TIA than sensory symptoms.5
Once a clinical diagnosis of TIA is made,
an ABCD2 score (age, blood pressure, clinical features, duration of TIA, presence of
diabetes) can be used to predict the shortterm risk of subsequent stroke (see Table
2, below).6,7 A general rule of thumb is to
admit patients who present within 72 hours
Risk factors for TIA mirror those for heart
disease. Non-modifiable risk factors include
older age, black race, male sex, and family
history of stroke. Modifiable factors include
hypertension, hyperlipidemia, tobacco
smoking, diabetes, and AF.4
Most of the time, patients’ symptoms will
have resolved by the time they are evaluated
by a physician. Therefore, the diagnosis of
TIA relies almost exclusively on the patient
history. Eliciting a good history helps physicians determine whether the episode of transient neurologic dysfunction was caused by
cerebral ischemia, as opposed to another
mechanism, such as migraine or seizure.
This calls for a basic understanding of cerebrovascular anatomy (see Table 1, below).
Types of Ischemia
Anterior cerebral artery ischemia causes contralateral leg weakness because it
supplies the medial frontal and parietal
lobes, where the legs in the sensorimotor homunculus are represented. Middle
continued on page
18
Table 1. Signs and symptoms used to help localize vascular ischemia
SIGNS AND SYMPTOMS
VESSEL
Contralateral hemiparesis
(leg > face and arm)
Anterior cerebral artery
Contralateral hemiparesis
(face and arm > leg)
Middle cerebral artery
Aphasia
Left middle cerebral artery
Monocular blindness
(amaurosis fugax)
Internal carotid artery
Diplopia, dysarthria, dysphagia,
vertigo, gait imbalance, weakness
Vertebral and basilar arteries
Table 2. ABCD2 score and stroke risk at two days
FACTOR
POINT SYSTEM
STROKE RISK AT
TWO DAYS
Age >60
1
0-3 = 1.0%
Blood pressure:
SBP >140 mm Hg
or DBP >90 mm Hg
1
4-5 = 4.1%
Unilateral weakness = 2
Speech disturbance without
weakness = 1
6-7 = 8.1%
Clinical features
Duration of
symptoms
Diabetes (history of)
<10 minutes = 0
10-59 minutes =1
>60 minutes = 2
1
Source: Adapted from The National Stroke Foundation. Clinical Guidelines for Stroke and TIA Management:
A quick guide for general practice. 2010.
KEY CLINICAL QUESTION I continued from page 17
of the event and have an ABCD2 score of
three or higher for observation, work-up,
and initiation of secondary prevention.1
Although only a small percentage of
patients with TIA will have a stroke during
the period of observation in the hospital, this
approach may be cost effective based on the
assumption that hospitalized patients are
more likely to receive intravenous tissue plasminogen activator.8 The decision should also
be guided by clinical judgment. It is reasonable to admit a patient whose diagnostic
workup cannot be rapidly completed.1
The workup for TIA includes routine
labs, EKG with cardiac monitoring, and
brain imaging. Labs are useful to evaluate
for other mimics of TIA such as hyponatremia and glucose abnormalities. In addition, risk factors such as hyperlipidemia and
diabetes should be evaluated with fasting
lipid panel and blood glucose. The purpose
of EKG and telemetry is to identify MI and
capture paroxysmal AF. The goal of imaging is to ascertain the presence of vascular disease and to exclude a non-ischemic
etiology. While less likely to cause transient neurologic symptoms, a hemorrhagic
event must be ruled out, as it would trigger
a different management pathway.
Imaging for TIA
There are two primary modes of brain
imaging: computed tomography (CT)
and MRI. Most patients who are suspected
ADDITIONAL READING
• Stroke Foundation. Clinical guidelines for stroke and TIA management: a quick guide for general practice. 2010. Available at: https://
strokefoundation.com.au/~/media/strokewebsite/resources/treatment/
nsf_concise_guidelines_gp_2010.ashx?la=en. Accessed November
1, 2015.
• Easton JD, Saver JL, Albers GW, et al. Definition and evaluation of
transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke
Association Stroke Council; Council on Cardiovascular Surgery and
Anesthesia; Council on Cardiovascular Radiology and Intervention;
Council on Cardiovascular Nursing; and the Interdisciplinary Council
on Peripheral Vascular Disease. The American Academy of Neurology
affirms the value of this statement as an educational tool for neurologists. Stroke. 2009;40(6):2276-2293.
• Gesensway D. The high-yield neuro exam: which elements test
the most brain? Today’s Hospitalist. January 2012. Available at:
www.todayshospitalist.com/index.php?b=articles_read&cnt=1415.
Accessed November 1, 2015.
to have had a TIA undergo CT scan, and
an infarct is seen about 20% of the time.1
The presence of an infarct usually correlates with the duration of symptoms and
has prognostic value. In one study, a new
infarct was associated with four times higher
risk of stroke in the subsequent 90 days.9
Diffusion-weighted imaging, an MR-based
technique, is the preferred modality when it
is available because of its higher sensitivity
and specificity for identifying acute lesions.1
In an international and multicenter study,
incorporating imaging data increased the
discriminatory power of stroke prediction.10
Extracranial imaging is mandatory to rule
out carotid stenosis as a potential etiology
of TIA. The least invasive modality is ultrasound, which can detect carotid stenosis
with a sensitivity and specificity approaching
80%.1 While both the intra- and extracranial vasculature can be concurrently assessed
using MR- or CT-angiography (CTA), this
is not usually necessary in the acute setting,
because only detecting carotid stenosis will
result in a management change.1
Carotid endarterectomy is standard for
symptomatic patients with greater than
70% stenosis and is a consideration for
symptomatic patients with greater than
50% stenosis if it is the most probable explanation for the ischemic event.11 Despite a
comprehensive workup, about 50% of TIA
cases remain cryptogenic.12 In some of these
patients, AF can be detected using extended
ambulatory cardiac monitoring.12
The goal of admitting high-risk patients
is to expedite workup and initiate therapy.
Two studies have shown that immediate
initiation of preventative treatment significantly reduces the risk of stroke by as
much as 80%.13,14 Unless there is a specific
indication for anticoagulation, all TIA
patients should be started on an antiplatelet agent such as aspirin or clopidogrel. A
large randomized trial conducted in China
and published in 2013 demonstrated
that dual antiplatelet therapy with aspirin and clopidogrel for 21 days, followed
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The goal of admitting high-risk patients is to expedite workup and initiate therapy.
Two studies have shown that immediate initiation of preventative treatment significantly
reduces the risk of stroke by as much as 80%.
Table 3. Risk reduction goals and benefits
References
MODIFIABLE
RISKMEDICATION
GOAL
RISK FACTOR
REDUCTION
OF CHOICE
Hypertension
Diabetes
Cholesterol
Lifestyle
changes
<140/90 mm Hg
Per ADA
guidelines
LDL <100 mm Hg
Quit smoking,
increase exercise,
reduce alcohol
consumption
by clopidogrel monotherapy, reduced the
risk of stroke compared to aspirin monotherapy. An international multicenter trial
designed to test the efficacy of short-term
dual antiplatelet therapy is ongoing, and if
the benefit of this approach is confirmed,
this will likely become the standard of care.
Evidence-based indications for anticoagulation after TIA are restricted to AF and
mural thrombus in the setting of recent
MI. Patients with implanted mechanical
devices, including left ventricular assist
devices and metal heart valves, should also
receive anticoagulation.15
Risk factors should also be targeted in
every case. Hypertension should be treated
with a goal of lower than 140/90 mm Hg
(or 130/80 mm Hg in diabetics and those
with renal disease). Studies have shown that
patients who are discharged with a blood
pressure lower than 140/90 mm Hg are
more likely to maintain this blood pressure
at one-year follow-up.16 The choice of medication is less well studied, but drugs that act
on the renin-angiotensin-aldosterone system
and thiazides are generally preferred.15 Treatment with a statin is recommended after
cerebrovascular ischemic events, with a
goal LDL under 100. This reduces risk of
secondary stroke by about 20%.17
At discharge, it is also important to
counsel patients on their role in preventing strokes. As with many diseases, making
lifestyle changes is key to stroke prevention. Encourage smoking cessation and an
increase in physical activity, and discourage
heavy alcohol use. The association between
smoking and the risk for first stroke is well
established. Moderate to high-intensity
exercise can reduce secondary stroke risk
by as much as 50%18 (see Table 3, above).
While light alcohol consumption can
be protective against strokes, heavy use
is strongly discouraged. Emerging data
30%
_
23%
ACEi/ARB,
CCB, thiazide
_
Atorvastatin 80
1. Easton JD, Saver JL, Albers GW, et al. Definition and
evaluation of transient ischemic attack: a scientific
statement for healthcare professionals from the American Heart Association/American Stroke Association
Stroke Council; Council on Cardiovascular Surgery
and Anesthesia; Council on Cardiovascular Radiology
and Intervention; Council on Cardiovascular Nursing;
and the Interdisciplinary Council on Peripheral Vascular
Disease. The American Academy of Neurology affirms
the value of this statement as an educational tool for
neurologists. Stroke. 2009;40(6):2276-2293.
2. Sundararajan V, Thrift AG, Phan TG, Choi PM, Clissold
B, Srikanth VK. Trends over time in the risk of stroke
after an incident transient ischemic attack. Stroke.
2014;45(11):3214-3218.
3. Albers GW, Caplan LR, Easton JD, et al. Transient
ischemic attack–proposal for a new definition. N Engl J
Med. 2002;347(21):1713-1716.
4. Grysiewicz RA, Thomas K, Pandey DK. Epidemiology of ischemic and hemorrhagic stroke: incidence,
prevalence, mortality, and risk factors. Neurol Clin.
2008;26(4):871-895, vii.
5. Johnston SC, Sidney S, Bernstein AL, Gress DR.
A comparison of risk factors for recurrent TIA and
stroke in patients diagnosed with TIA. Neurology.
2003;60(2):280-285.
6. Tsivgoulis G, Stamboulis E, Sharma VK, et al. Multicenter external validation of the ABCD2 score in triaging
TIA patients. Neurology. 2010;74(17):1351-1357.
50%
NA
7. Johnston SC, Rothwell PM, Nguyen-Huynh MN, et al.
Validation and refinement of scores to predict very early
stroke risk after transient ischaemic attack. Lancet.
2007;369(9558):283-292.
8. Nguyen-Huynh MN, Johnston SC. Is hospitalization
after TIA cost-effective on the basis of treatment with
tPA? Neurology. 2005;65(11):1799-1801.
suggest obstructive sleep apnea (OSA) may
be another modifiable risk factor for stroke
and TIA, so screening for potential OSA
and referral may be needed.15
Back to the Case
When Mr. G arrived at the ED, his symptoms had resolved. Based on the history of
expressive aphasia and right-sided weakness, he most likely had a TIA in the left
MCA territory. Hemorrhage was ruled out
with a non-contrast head CT. His pacemaker precluded obtaining an MRI. CTA
revealed diffuse atherosclerotic disease
without evidence of carotid stenosis. His
ABCD2 score was six given his age, blood
pressure, weakness, and symptom duration, and he was admitted for an expedited workup. His sodium and glucose were
within normal limits. His hemoglobin A1c
was 6.5%, his LDL was 120, and his international normalized ratio (INR) was therapeutic at 2.1. His TIA may have been due
to AF, despite a therapeutic INR, because
warfarin does not fully eliminate the stroke
risk. It might also have been caused by
intracranial atherosclerosis.
Two days later, the patient was discharged
on atorvastatin at 80 mg, and his lisinopril
was increased for blood pressure control. For
his age group, A1c of 6.5% was acceptable,
and he was not initiated on glycemic control.
9. Douglas VC, Johnston CM, Elkins J, Sidney S, Gress
DR, Johnston SC. Head computed tomography
findings predict short-term stroke risk after transient
ischemic attack. Stroke. 2003;34(12):2894-2898.
10. Giles MF, Albers GW, Amarenco P, et al. Addition of
brain infarction to the ABCD2 Score (ABCD2I): a
collaborative analysis of unpublished data on 4574
patients. Stroke. 2010;41(9):1907-1913.
11. Lanzino G, Rabinstein AA, Brown RD Jr. Treatment
of carotid artery stenosis: medical therapy, surgery, or
stenting? Mayo Clin Proc. 2009;84(4):362-387; quiz
367-368.
12. Gladstone DJ, Spring M, Dorian P, et al. Atrial fibrillation
in patients with cryptogenic stroke. N Engl J Med.
2014;370(26):2467-2477.
13. Lavallée PC, Meseguer E, Abboud H, et al. A transient
ischaemic attack clinic with round-the-clock access
(SOS-TIA): feasibility and effects. Lancet Neurol.
2007;6(11):953-960.
14. Rothwell PM, Giles MF, Chandratheva A, et al. Effect of
urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study):
a prospective population-based sequential comparison.
Lancet. 2007;370(9596):1432-1442.
15. Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with
stroke and transient ischemic attack: a guideline for
healthcare professionals from the American Heart
Association/American Stroke Association. Stroke.
2014;45(7):2160-2236.
16. Roumie CL, Zillich AJ, Bravata DM, et al. Hypertension
treatment intensification among stroke survivors with
uncontrolled blood pressure. Stroke. 2015;46(2):465470.
17. Amarenco P, Bogousslavsky J, Callahan A, et al. Highdose atorvastatin after stroke or transient ischemic
attack. N Engl J Med. 2006;355(6):549-559.
18. Lennon O, Galvin R, Smith K, Doody C, Blake C.
Lifestyle interventions for secondary disease prevention
in stroke and transient ischaemic attack: a systematic
review. Eur J Prev Cardiol. 2014;21(8):1026-1039.
SHM
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Bottom Line
TIAs are diagnosed based on patient history.
Urgent initiation of secondary prevention is
important to reduce the short-term risk of
stroke and should be implemented by the
time of discharge from the hospital.
Dr. Zeng is a hospitalist in the department of internal medicine
at Vanderbilt University Medical Center in Nashville, and Dr.
Douglas is associate professor in the department of neurology
at the University of California at San Francisco.
www.thedoctors.com/SHM
INNOVATIONS I Quality, patient safety, and technology initiatives I By Larry Beresford
QUALITY
QUALITY IMPROVEMENT
INITIATIVE TARGETS SEPSIS
A
quality improvement (QI) initiative at University Hospital enter them real-time into electronic health records (EHR), and
in Salt Lake City aims to save lives and cut hospital costs receive prompts from abnormal vital signs to retake all vitals and
confirm abnormal results. It also incorporates EHR decision support
by reducing inpatient sepsis mortality.
Program co-leaders, hospitalists Devin Horton, MD, and Kencee tools, including links to pre-populated medical order panels, such as
Graves, MD, of University Hospital, launched the initiative as a for the ordering of tests for lactate and blood cultures.
pilot program last October. They began by surveying hospital house
“Severe sepsis is often quoted as the number one cause of mortalstaff and nurses on their ability to recognize and define six different ity among hospitalized patients, with a rate up to 10 times that of
sepsis syndromes from clinical vignettes. A total of 136 surveyed acute myocardial infarction,” Dr. Horton explains. “The one treatresidents recognized the correct condition
only 56% of the time, and 280 surveyed
“We developed a robust teaching program for
nurses only did so 17% of the time.
nurses and residents using Septris, an online
The hospitalists determined that better
education about sepsis was crucial.
educational game from Stanford University.”
“We developed a robust teaching
–Dr. Horton
program for nurses and residents using
Septris, an online educational game from Stanford University,” Dr. ment that consistently decreases mortality is timely administration
Horton says. The team also developed technology that can recognize of antibiotics. But, in order for a patient to be given timely antiworsening vital signs in a patient and automatically trigger an alert biotics, the nurse or resident must first recognize that the patient
to a charge nurse or rapid response team.
has sepsis.”
The team’s Modified Early Warning System (MEWS) for recog“This is one of the biggest and most far-reaching improvement
nizing sepsis is similar to the Early Warning and Response System initiatives that has been done at our institution,” says Robert Pendle(EWRS) system used at the University of Pennsylvania Health ton, MD, chief quality officer at University Hospital. Dr. Horton says
System and the University of California San Diego, and draws on he predicts the program will “save 50 lives and $1 million per year.”
For more information, contact him at: devin.horton@hsc.
other hospitals’ sepsis systems. Dr. Horton says one difference in
their system is the involvement of nursing aides who take vital signs, utah.edu.
PATIENT SAFETY
New Guide Helps Hospitalists Identify
Most Appropriate Catheter
T
BY THE NUM BERS
MICHIGAN APPROPRIATENESS GUIDE FOR INTRAVENOUS CATHETERS (MAGIC)
he Michigan Appropriateness
international experts
Guide for Intravenous Catheon catheters and their
ters (MAGIC) is a new resource
infections and complidesigned to help clinicians select the
cations, including the
safest and most appropriate peripherauthors of existing
ally inserted central catheter (PICC)
guidelines, to brainfor individual patients.
storm more than 600
“How do you decide which catheclinical scenarios and
ter is best for your patient? Until now
best evidence-based
practice for catheter
there wasn’t a guide bringing together
all of the best available evidence,” says
use using the Rand/
the guide’s lead author Vineet Chopra,
UCLA Appropriateness Method. “We
MD, MSc, FHM, a hospitalist and
also had a patient
assistant professor of medicine at the
on the panel, which
University of Michigan in Ann Arbor.
“These are among the most
was important to the
commonly performed procedures on Vascular access devices reviewed to formulate appropriateness ratings.
clinicians because this
any hospitalized patient, and yet, the
patient had actually
least studied,” he adds. “We as hospitalists are the physicians used many of the devices being discussed,” Dr. Chopra explains.
The guidelines “have the potential to change the game for hospiwho order most of these devices, especially PICCs.”
The guide includes algorithms and color-coded pocket cards talists,” Dr. Chopra adds. “There has never before been guidance on
to help physicians determine which PICC to choose. The cards using IV devices in hospitalized medical patients, despite the fact
can be freely downloaded and printed from the Improve PICC that we use these devices every day. Now, for the first time, we not
website at the University of Michigan.
only have guidance but also a tool to benchmark the quality of
The project to develop the guide brought together 15 leading care provided by doctors when it comes to venous access.”
99
20
%
PROPORTION OF MEDICAL-DEVICE MONITORING
ALERTS ON REGULAR HOSPITAL UNITS THAT
WERE FOUND NOT TO BE ACTIONABLE,
ACCORDING TO A STUDY BY PEDIATRICIAN AND
RESEARCHER CHRIS BONAFIDE, MD, MSCE, AT
CHILDREN’S HOSPITAL OF PHILADELPHIA, BASED ON REVIEWING HOURS
OF VIDEO FROM PATIENT ROOMS.1
Reference
1. Bonafide CP, Lin R, Zander M, et al.
Association between exposure to
nonactionable physiologic monitor
alarms and response time in a children’s hospital. J Hosp Med. 2015;
10(6):345–351.
Larry Beresford is a freelance writer
in Alameda, Calif.
PATIENT SAFETY
IOM Report
Examines
Medical
Misdiagnoses
I
n the latest report in its series on
quality and patient safety in healthcare, the Institute of Medicine
addresses the challenge of errors in
medical diagnoses.
Authors of the IOM’s “Improving Diagnosis in Health Care” report cite problems
in communication and limitations in electronic health records behind inaccurate
and delayed diagnoses, concluding that
the problem of diagnostic errors generally
has not been adequately studied.1
“This problem is significant and serious. Yet we don’t know for sure how often
it occurs, how serious it is, or how much
it costs,” said the IOM committee’s chair,
John Ball, MD, of the American College of
Physicians, in a prepared statement. The
report concludes there is no easy fix for
the problem of diagnostic errors, which
are a leading cause of adverse events in
hospitals and of malpractice lawsuits for
hospitalists, but calls for a major reassessment of the diagnostic process.2
Hospitalist Mangla Gulati, MD, FACP,
SFHM, assistant chief medical officer at
the University of Maryland Medical Center
in Baltimore, says hospitalists would be
remiss if they failed to take a closer look
at the IOM report. “Diagnostic error is
something we haven’t much talked about
in medicine,” Dr. Gulati says. “Part of the
goal of this report is to actually include the
patient in those conversations.” Patients
who are rehospitalized, she says, may
have been given an incorrect initial diagnosis that was never rectified, or there may
have been a failure to communicate important information.
“How many tests do we order where
results come back after a patient leaves
the hospital?” asks Kedar Mate, MD,
senior vice president at the Institute for
Healthcare Improvement and a hospitalist at Weill Cornell Medicine in New York
City. “How many in-hospital diagnoses are
made without all of the available information from outside providers?”
One simple intervention hospitalists could do immediately, he says, is to
start tracking all important tests ordered
for patients on a board in the medical
team’s meeting room, only removing them
from the board when results have been
checked and communicated to the patient
and outpatient provider.
References
1. National Academies of Sciences, Engineering,
and Medicine. Improving Diagnosis in Health Care.
Washington, DC: The National Academies Press.
2015.
2. Saber Tehrani AS, Lee HW, Mathews SC, et al.
25-year summary of U.S. malpractice claims for
diagnostic errors 1986–2010: An analysis from
the National Practitioner Data Bank. BMJ Qual
Saf. 2013 Aug; 22(8):672–680.
ON THE HORIZON I Quality, systems, safety I By Win Whitcomb, MD, MHM and Justin Psaila, MD, FHM
Early Mobility Program
When “out of bed with assist” orders aren’t enough
Figure 1. Barthel Index.4
“I didn’t get out of bed for 10 days”
ACTIVITYSCORE
FEEDING
0 = unable
5 = needs help cutting food,
spreading butter, and so on,
or requires modified diet
10 = independent R
____
BATHING
0 = dependent
5 = independent
(or in shower)
____
GROOMING
0 = needs help with
personal care
5 = independent
face/hair/teeth/shaving
(implements provided)
____
DRESSING
0 = dependent
5 = needs help but can
do about half unaided
10 = independent
(including buttons, zips,
laces, other fasteners)
____
BOWELS
0 = incontinent (or needs
to be given enemas)
5 = occasional accident
10 = continent
____
BLADDER
0 = incontinent, or
catheterized and unable to
manage alone
5 = occasional accident
10 = continent
____
TOILET USE
0 = dependent
5 = needs some help, but
can do something alone
10 = independent
(on and off, dressing, wiping)
TRANSFERS
(BED TO CHAIR AND BACK)
0 = unable, no sitting balance
5 = major help (one or two
people, physical), can sit
10 = minor help
(verbal or physical)
15 = independent
____
____
____
STAIRS
0 = unable
5 = needs help (verbal,
physical, carrying aid)
10 = independent
____
TOTAL (0-100):
eadmission penalties, “Medicare
spending per beneficiary” under
value-based purchasing, and the
move to accountable care are propelling
hospitalists to do more to ensure our patients
recover well in the least restrictive setting,
without returning to the hospital. As we
build systems to support patient recovery,
we are focused on a medical model, paying
attention to managing diseases and reconciling medications. At the same time, there is
a growing awareness that functional status
and mobility are critical pieces of patient
care during and post-hospitalization.
Regardless of principal diagnosis and
comorbidities, patients’ functional mobility ultimately determines their trajectory
during recovery. To illustrate the importance
of functional status and outcomes, one study
showed that models predicting readmission
based on functional measures outperformed
those based on comorbidities.1
The negative effects of hospitalization on
patient mobility, and in turn, on recovery,
have been recognized for a long time. Immobility is associated with functional decline,
which contributes to falls, increased length
of stay, delirium, loss of ability to perform
activities of daily living, and loss of ambulatory independence. A number of studies have
reported successful early mobility programs
in critical care and surgical patients.2 Fewer
have been reported in general medical
patients.3 Taken together, they suggest that
a program for mobilizing patients, using
a team approach, is an important part of
recovery during and after hospitalization.
The purpose of this column is to report
the components of one healthcare system’s
mobility program for general medical-surgical patients.
Early Mobility: A Case Study
MOBILITY
(ON LEVEL SURFACES)
0 = immobile or <50 yards
5 = wheelchair independent,
including corners, >50 yards
10 = walks with help of
one person (verbal or
physical) >50 yards
15 = independent
(but may use any aid;
for example, stick) >50 yards
—Anonymous patient admitted to a
skilled nursing facility post-hospitalization
for a COPD exacerbation
____
St Luke’s University Health Network
(SLUHN) in northeastern Pennsylvania has
implemented an early mobility program as
part of its broader strategy to reduce readmissions and discharge as many patients
home as possible. Although the SLUHN
early mobility program depends on nursing, nursing assistants, and the judicious use
of therapists, physician leadership during
implementation and maintenance of the
program has been essential. Moreover,
because the program represents a culture
shift, especially for nursing, leadership and
change management are crucial ingredients
for success. Below are the key steps in the
SLUHN early mobility program.
Establish baseline functional status.
Recording baseline function is an essential
first step. For patients admitted through
the ED, nurses collect ambulatory status,
patient needs for assistance, ambulatory
aids/special equipment, and history of falls.
Dr. Whitcomb
Dr. Justin Psaila
is Chief Medical Officer of
Remedy Partners. He is
co-founder and past president
of SHM. Email him
at wfwhit@comcast.net.
is network chair of medicine
and section chief of hospital
medicine, St. Luke’s
University Health Network,
Bethlehem, Pa.
They populate an SBAR (situation, background, assessment, recommendation) form
with this information and, as part of the
handoff, ensure that it is transmitted to the
inpatient nurse receiving the patient.
Obtain and document Barthel Index
score. SLUHN uses the Barthel Index (see
Figure 1) to establish a patient’s degree of
independence and need for supervision.
The index is scored on a 0-100 scale, with
a higher score corresponding to a greater
degree of independence. SLUHN created
three categories: 0-59, stage 1; 60-84, stage
2; 85-100, stage 3.
Patient mobility plan. Based on the
Barthel-derived stage, a patient is assigned
a mobility plan.
The role of nursing. The patient’s registered nurse is responsible for implementing the “patient mobility plan.” The nurse
hours, the nurse aims to move the patient
to the next stage by reevaluating the Barthel
Index and going through the same steps as
those followed during the initial scoring.
The process moves the patient to higher
activity levels, unless there are intervening
problems affecting mobility.
In such cases, according to the Barthel
Index, the patient may remain at the same—
or be moved to a lower—activity level. In
practice, patients are assessed each shift,
and those with higher function (stage 3) are
progressed to unsupervised ambulation.
The role of physical and occupational
therapy. Although the role of physical and
occupational therapists in the SLUHN
mobility program is well codified, it is
reserved for patients with complex rehabilitation needs due to the number of patients
requiring rehabilitation.
Regardless of principal diagnosis
and comorbidities, patients’ functional
mobility ultimately determines their
trajectory during recovery.
initiates an “interdisciplinary plan of care,”
in which the mobility stage is written on
the SBAR handoff report tool. The report
is discussed at change of shift and at multidisciplinary rounds. Nursing also communicates the mobility plan to the nursing
assistants and assigns responsibilities for the
mobility plan (activities of daily living, out
of bed, ambulation, and so on), including
verifying documentation of daily activities
and assessing the patient’s response to the
activity level of the assigned stage.
Further, nursing maintains and revises
the mobility status on the SBAR, updates
progress toward outcomes on the care
plan, consults with the physician and team
regarding the discharge plan, and discusses
progress with the patient and family.
The role of the nursing/patient care
assistant. The nursing assistant is responsible for implementing elements of the plan,
such as activities of daily living, getting out
of bed, and ambulation, under the guidance
of the nurse. The nursing assistant reports
patient responses to activity level and reflects
mobility goals back to the patient verbally
and through white board messaging.
Patient progress in mobility. When a
patient sustains progress at one stage for 24
In sum, this patient mobility program–
for non-ICU hospitalized patients–relies on:
• Documentation of baseline function;
• Independent scoring using the Barthel
Index;
• Creation of clear roles for nursing, nursing assistants, and therapists; and
• Reevaluation of patients at regular intervals based on the Barthel Index, so that
they may progress to greater activity
levels (or to lower levels in the case of
a setback).
A key subsequent step, an evaluation
of the program’s performance in terms
of readmissions, transfer rates to a skilled
nursing facility, and skilled facility length
of stay, has shown positive results in all
three domains.
References
1. Shi SL, Girrard P, Goldstein R, et al. Functional status
outperforms comorbidities in predicting acute care readmissions in medically complex patients. J Gen Intern
Med. 2015;30(11):1688-1695.
2. Dammeyer JA, Baldwin N, Packard D, et al. Mobilizing
outcomes: implementation of a nurse-led multidisciplinary mobility program. Crit Care Nurs Q.
2013;36(1):109-119.
3. Wood W, Tschannen D, Trotsky A, et al. A mobility
program for an inpatient acute care medical unit.
Am J Nurs. 2014;114(10):34-40.
4. Mahoney FI, Barthel DW. Functional evaluation: the
Barthel Index. Md State Med J. 1965;14:61-65.
UNASSIGNED
AND UNDOCUMENTED
PATIENTS
1
continued from page
22
Treatment Challenges
Uninsured patients often are sicker and
have more complex conditions than those
with insurance, according to Beth Feldpush, DrPH, senior vice president of policy and advocacy at the nonprofit trade
group America’s Essential Hospitals, which
is based in Washington, D.C., and represents 250 safety net hospitals throughout
the U.S.
LISTEN NOW
Typically, undocumented and unassigned
patients face many social and economic
challenges. Many of these patients are unemployed or work as independent contractors
without employer-offered health insurance.
Some have multiple jobs, can’t take time off
from work for doctor appointments, or are
undocumented workers.
More patients have acquired health insurance in recent years as a result of the Affordable Care Act (ACA) and Medicaid expansion; however, some eligible people never
complete the necessary forms.
With or without insurance, some patients
don’t establish primary care because they
have been healthy, have difficulty navigating the healthcare system, lack transportation, or desire more culturally tailored care.
Some Medicare and Medicaid patients don’t
have a PCP in their community who accepts
these programs.
“Because they can’t afford regular preventive and primary care, they forgo needed
healthcare services until their conditions
worsen and they require costly hospital
care,” says Dr. Feldpush. Uninsured patients
often lack the resources for follow-up care
to help them recover and stay well. She says
more than half of all inpatient discharges
and outpatient visits at her groups’ hospitals are for uninsured or Medicaid patients.
Scott Sears, MD, FACP, chief clinical officer for Sound
Physicians in Tacoma, Wash., discusses why patients without health insurance put hospitalists in a difficult situation.
There are cost pressures to discharge patients—particularly
because hospitals don’t get fully reimbursed to provide care
to uninsured patients and, consequently, end up subsidizing
them. Meanwhile, there are incentives to meet certain
quality measures, coupled with a lack of providers.
www.the-hospitalist.org/audio
When an uninsured patient is discharged
from the hospital, finding follow-up care
can be difficult.
“Their ability to get an appointment to
see a PCP is extremely limited, because
many providers don’t see patients without
health insurance,” says Scott Sears, MD,
MBA, chief clinical officer of Tacoma,
Wash.-based Sound Physicians. Dr. Sears
notes that in some hospitalist programs, as
many as 40% of hospitalized patients lack
insurance. “But without secured followup care, hospitalists are hesitant to send
patients home, because they could relapse.”
Typically, these patients are not
completely well and should be transferred to
a skilled nursing or hospice facility; however,
many facilities won’t accept them without
insurance. Often, these patients need a
PCP to monitor them with laboratory tests
and other follow-up tests, to prescribe and
monitor medications, and to ensure that
they are following their plan of care.
At some medical facilities, subspecialists
who consult on patients may screen them
and refuse to see anyone without health
insurance.
“So even though some patients may
need subspecialty support, they may not
have access to it,” Dr. Sears says. “While
some patients without insurance qualify
for Medicaid or other programs, due to the
amount of paperwork and time to enroll,
they end up staying in the hospital even
though they are ready for discharge.”
Figure 1. Reasons for Being Uninsured among Uninsured Adults, Fall 2014
Transitional Challenges
Most patients admitted to the hospital either have exacerbations of chronic
conditions or a new diagnosis. “It’s rare to
hospitalize a patient with a discrete illness
that wouldn’t need care after discharge, so
having a robust PCP partner is critical to a
patient’s health,” says Honora Englander,
MD, medical director of the Care Transitions Innovation (C-TRAIN) program
at Oregon Health and Science University
(OHSU) in Portland. For many patients,
psychosocial complexity complicates their
transition out of the hospital. An effective
system needs to address a patient’s mental
health, housing, and other social needs.
It may take four to six weeks for a patient
without an established PCP to get a new
patient appointment. “This is a huge
impediment, as the patient won’t have
anyone to ensure that he or she continues
along the proper care path,” Dr. Sears says.
“Studies estimate that more than half of
medication errors that patients experience
occur during transitions and after discharge,”
Dr. Sears says.2 “Intervention with a healthcare provider who can review proper use after
discharge can dramatically reduce errors and
[improve] patient outcomes.”
Rates of patients without a PCP vary by
region for Sound Physicians. In the northwest region, about 25% of admitted patients
lack a PCP; in the gulf region, the figure can
be as high as 60%.
“In Texas, there is a large number of
patients and not as many PCPs,” he adds.
“There is also a larger percentage of patients
without health insurance. Sometimes
patients have coverage but have never established care with a PCP.”
As a result of not having a PCP to transition to, some patients return to the hospital
soon after discharge, Dr. Feldpush notes.
Tips for Treating
Uninsured Patients
Some facilities have found successful
ways to help hospitalized patients without health insurance. Dr. Sears says that
hospitalists can investigate which clinics
accept uninsured patients or which local
physician groups are willing to see them
after discharge, in exchange for hospitalists
taking care of them in the hospital. They
also can investigate the community-based
insurance programs that are available.
Teresa Coker, MSN, ARNP, FNP-BC,
a Sound Physicians program manager at
Mercy Medical Center in Cedar Rapids,
Iowa, says that when patients lack insurance
at her hospital, an organization will review
the patient’s case, determine insurance eligibility, and assist the patient in completing
NOTE: Includes uninsured adults ages 19-64.
SOURCE: 2014 Kaiser Survey of Low-Income Americans and the ACA.
Figure 2. Characteristics of the Nonelderly Uninsured, 2014
NOTES: The U.S. Census Bureau's poverty threshold for a family with two adults and one child was $19,055 in 2014. Data may not total 100% due to rounding.
SOURCE: Kaiser Family Foundation analysis of the 2015 ASEC Supplement to the CPS.
the appropriate paperwork.
When patients are not
eligible, they are instructed
to inquire about the hospital’s charity care program if
they receive a bill they are
unable to pay.
Coker
In addition, the community has a free health clinic that serves those
without insurance. “Patients are given the
address and hours prior to discharge, because
it is walk-in only,” Coker says. “All patients
are recommended to follow up within one
week, or sooner if medications are needed.”
Dr. Englander advocates that physicians take
into account medication
costs, transportation, and
other social considerations
when planning care after
hospitalization. The team
Dr. Englander
at OHSU developed a lowcost formulary (based in part on widely
available $4 plans from national pharmacy
chains), and OHSU provides medications
for uninsured patients in the program for up
to 30 days following discharge.
For patients who can’t afford the $4 drug
plan, case managers offer
coupons for $4 prescriptions, says Malik Merchant,
MD, area medical officer
for the Schumachergroup
in Harker Heights, Texas.
He says that as many as
Dr. Merchant
30% of the patients in his
area are undocumented or unassigned. For
more expensive medications, a social worker
offers pharmaceutical company coupons
when they are available. The institution also
has a small budget to pay for drugs.
continued on page
24
UNASSIGNED
AND UNDOCUMENTED
PATIENTS
continued from page
Dr. Merchant has found the biggest
challenge to be the transition of care from
inpatient to outpatient.
“Case managers and social workers
prepare a financial worksheet that provides
the possibility of overall cost savings for
the institution, if patients are willing to
participate in some upfront cost,” he says.
“When our parent institution came on
board, we developed contracts with local
pharmacies, [a] skilled nursing facility,
and PCPs to take these patients until they
recovered from an acute illness. Our institution paid for these services at a reduced
rate but saved money by reducing the
length of their hospital stay.”
Dr. Feldpush says her group’s hospitals
work hard to reach the uninsured. South
Florida’s Memorial Healthcare System
(MHS) created the Health Intervention
with Targeted Services (HITS) Program,
an outreach initiative that links patients
with insurance programs or medical
homes.3 The HITS team
used a geographic information system map to
target 15 neighborhoods
with the highest rates of
hospitalized, uninsured
patients. Over a sixmonth period, the team
Dr. Feldpush
approached these neighborhoods using various outreach strategies, such as health fairs, educational
workshops, and door-to-door visits.3
Approximately 6,910 HITS participants have been enrolled in Medicaid, Florida’s children’s health insurance
program, or an MHS community health
center. Over a three-year study period,
MHS saved $284,856 in the ED, about
$2.8 million in inpatient costs, and roughly
$4 million overall.3
Barriers to Follow-Up Care
Whether you are looking to help uninsured patients, those without a PCP, or
both, the key is to try to fill in the gaps.
“As hospitalists, we need to work with
pharmacists, case managers and social
workers, and others to identify affordable
and effective ways to provide care,” Dr.
Englander says. “Interprofessional team
members, community partners, and family
members can help hospitalists understand
patient and population health needs and
available resources.”
In an effort to close transitional care
gaps, OHSU developed the C-TRAIN
program, a multi-component transitional
care intervention that includes four main
elements:
1. Transitional care nurse who sees
patients in the hospital, makes
home visits, and helps coordinate
care 30 days post-discharge;
2. Inpatient pharmacy consultation
and prescription medications at
discharge from a low-cost, valuebased formulary;
3. Medical home linkages, whereby
24
23
OHSU partners with and provides
payment to three community clinics to provide primary care for uninsured patients; and
4. Monthly implementation team
meetings that convene diverse
healthcare stakeholders to integrate
elements of the healthcare system
and engage in ongoing quality
improvement.
The Schumachergroup has also found
an effective solution.
“The department head of our case
managers and social workers made an
agreement with a local multispecialty
group,” Dr. Merchant says. “The group
agreed to take all discharged patients
and be their PCP for 30 days, even if
the patient couldn’t pay, in exchange
for receiving all patients who had good
insurance but did not have an established PCP.
“This has worked well. Every patient
discharged from our facility has a PCP
listed at discharge, and the unit clerk
makes an appointment and documents
it in the electronic medical record.”
Sound Physicians has set up a service
line, called transitional care services, to
smooth transitions of care after discharge
for up to 90 days, depending on their clinical needs. It hires providers who work in
post-acute facilities and who can also visit
patients at home. After discharge, a nurse
practitioner will visit the patient, connect
him or her with a PCP, and get the patient
access to care.
“Smaller hospitalist groups could set up
post-discharge clinics,” Dr. Sears suggests,
“so when they discharge a patient without
a PCP, [the patient] could return to see
one of the hospitalists there.”
Mount Carmel East Hospital, a Sound
Physicians’ hospital in Columbus, Ohio,
has a financial assistance program.
“The case management department
provides community
health resources to
patients who are insured
but have no PCP,” says
Shelli Morris, RN. “We
also have a hotline that
patients can call for a list
Morris
of PCPs that are accepting new patients.”
When a patient lacks insurance or a
PCP, Morris is contacted by the physician
or case management to provide a referral
to a neighborhood health clinic. “Then,
as a courtesy, we set up a post-hospital
follow-up appointment,” she says.
By working with other care team
members at facilities such as outpatient
clinics and pharmacies, hospitalists and
other staff have been able to improve care
for patients without insurance or a PCP
after discharge. Knowing the funding
that is available, as well as programs to
help these patients, is also integral.
Figure 3. Uninsured Rates among the Nonelderly by State, 2014
SOURCE: Kaiser Family Foundation analysis of the 2015 ASEC Supplement to the CPS.
COSTS OF THE UNINSURED ADD UP
T
he U.S. government estimates that approximately
49 million Americans don’t have health insurance.
Seven million (9.4%) of those are under the age of
18. Less than 2% are over the age of 65. Racially, 30% are
Hispanic, 20% are black, and 15% are white.4,5
In 2013, the cost of “uncompensated care” provided to uninsured individuals reached $84.9 billion.
Uncompensated care includes healthcare services without a direct source of payment. The majority of uncompensated care (60%) is provided in hospitals. Communitybased providers (including clinics and health centers) and
office-based physicians provide the rest, providing 26%
and 14% of uncompensated care, respectively.6
In 2013, $53.3 billion was paid to help providers offset
uncompensated care costs. Most of these funds ($32.8
billion) came from the federal government through programs such as Medicaid, Medicare, and the Veterans
Health Administration. States and localities provided
$19.8 billion, and the private sector provided $0.7 billion.6
Karen Appold is a medical writer in Pennsylvania.
References
1. American Hospital Association. American Hospital Association Uncompensated Hospital Care Cost Fact Sheet.
Available at: http://www.aha.org/content/15/uncompensatedcarefactsheet.pdf. Accessed October 8, 2015.
2. The Office of the National Coordinator for Health Information Technology. Health IT in long-term and post acute
care: issue brief. March 15, 2013. Available at: http://www.healthit.gov/sites/default/files/pdf/HIT_LTPAC_IssueBrief031513.pdf. Accessed October 8, 2015.
3. Addison E. Gage award winner HITS the streets to
connect with the uninsured. America’s Essential Hospitals. July 22, 2014. Available at: http://essentialhospitals.
org/quality/gage-award-winner-hits-the-streets-to-connect-with-the-uninsured/. Accessed October 8, 2015.
4. DeNavas C, Proctor BD, Smith JC. Income, poverty, and health insurance coverage in the United States: 2010.
United States Census Bureau. September 2011. Available at: http://www.census.gov/prod/2011pubs/p60239.pdf. Accessed October 8, 2015.
5. United States Census Bureau. People without health insurance coverage by selected characteristics: 2010 and
2011. Available at: http://www.census.gov/hhes/www/hlthins/data/incpovhlth/2011/Table7.pdf. Accessed
October 8, 2015.
6. Coughlin TA, Holahan J, Caswell K, McGrath M. Uncompensated care for the uninsured in 2013: a detailed examination. The Henry J. Kaiser Family Foundation. May 30, 2014. Available at: http://kff.org/uninsured/report/
uncompensated-care-for-the-uninsured-in-2013-a-detailed-examination/. Accessed October 8, 2015.
physician burnout continued from page
idea of medical teams employing a documentation specialist, or scribe, to accompany
physicians on patient rounds to help with
the clerical tasks that divert physicians from
patient care. She also cited David Reuben,
MD, a gerontologist at UCLA whose JAMA
Internal Medicine study documented his
training of physician “practice partners,”
often medical or nursing students, who
help queue up orders in the EHR, and the
improved patient satisfaction that resulted.2
“Be bold,” she advised hospitalists. “The
patient care delivery modes of the future
can’t be met with staffing models from the
past.”
References
1. Friedberg M, Chen PG, Van Busum KR, et al. Factors
affecting physician professional satisfaction and their
implications for patient care, health systems, and health
policy. 2013. Available at: http://www.rand.org/pubs/
research_reports/RR439. Accessed November 3, 2015.
2. Reuben DB, Knudsen J, Senelick W, Glazier E, Koretz
BK. The effect of a physician partner program on physician efficiency and patient satisfaction. JAMA Intern Med.
2014;174(7):1190-1193.
Larry Beresford is a freelance writer in Alameda, Calif.
Thrombosis Management Demands Delicate, Balanced Approach
By Larry Beresford
T
he delicate balance involved in
providing hospitalized patients with
needed anticoagulant, anti-platelet,
and thrombolytic therapies for stroke and
possible cardiac complications, while minimizing bleed risks, was explored by several
speakers at the University of California
San Francisco’s annual Management of the
Hospitalized Patient conference.
“These are dynamic issues and they’re
moving all the time,” said Tracy Minichiello,
MD, a former hospitalist who now runs Anticoagulation and Thrombosis Services at the
San Francisco VA Medical Center. Dosing
and monitoring choices for physicians have
grown more complicated with the new oral
anticoagulants (apixaban, dabigatran, and
rivaroxaban), and Dr. Minichiello said another
and benefits,” she said. Physicians should also think twice
balancing act is emerging in hospitals trying
about concomitant antiplatelet therapy, like aspirin with anticoto avoid unnecessary and wasteful treatments.
agulants. “We need to work collaboratively with our cardiology
“There is interest on both sides of that question,” Dr.
colleagues when a patient is on two or three of these therapies,”
Minichiello said, adding that the stakes are high. “We don’t
she said. “Recommendations in this area are in evolution.”
want to miss the diagnosis of pulmonary embolisms, which
Elise Bouchard, MD, an internist at Centre Maria-Chapdelaine
can be difficult to catch. But now there’s more discussion
in Dolbeau-Mistassini, Québec, attended
of the other side of the issue—
Dr. Minichiello’s breakout session on
overdiagnosis and overtreat“We don’t want to
challenging cases.
ment—where we’re also trying to
miss the diagno“I learned that we shouldn’t use aspirin
avoid, for example, overuse
sis of pulmonary
with Coumadin or other anticoagulants, except
of CT scans.”
embolisms, which for cases like acute coronary syndrome,”
Another major thrust of
Dr. Bouchard said. She also explained that a
can be difficult to
Dr. Minichiello’s presentations
number of her patients with cancer, for examinvolved bridging therapies,
catch. But now
ple, need anticoagulation treatment and hate
the application of a parenteral,
there’s more discussion of the
short-acting anticoagulant therother side of the issue—overdiag- getting another injection, so she tries to offer
the oral anticoagulants whenever possible.
apy during the temporary internosis and overtreatment—where
Dr. Minichiello works with hospitalists at
ruption of warfarin anticoagulawe’re also trying to avoid, for
the San Francisco VA who seek consults
tion for an invasive procedure.
example, overuse of CT scans.”
around performing procedures, choosing
Bridging decreases stroke and
—Tracy Minichiello, MD
anticoagulants, and determining when to
embolism risk but comes with
restart treatments.
an increased risk for bleeding.
“Most hospitalists don’t have access to a service like ours,
“Full intensity bridging therapy for anticoagulation
although they might be able to call on a hematology consult
potentially can do more harm than good,” she said, noting a
service [or pharmacist],” she said. She suggested that hospitaldearth of data to support mortality benefits of bridging therapy.
ists trying to develop their own evidenced-based protocols use
Literature increasingly recommends that hospitalists
websites like the University of Washington’s Anticoagulation
be more selective about the use of bridging therapies
Services website, or the American Society of Health System
that might have been employed reflexively in the past, Dr.
Pharmacists’ Anticoagulation Resource Center.
Minichiello noted. “[Hospitalists] must be mindful of the risks
SHUTTERSTOCK.COM
MEETING
1
ucsf roundup continued on page
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ucsf roundup continued from page
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For Some Inpatients with Cirrhosis,
ROUNDUP
LIVER TRANSPLANT IS THE ONLY CURE
By Larry Beresford
B
ilal Hameed, MD, assistant
professor of medicine in the
division of gastroenterology
at the University of California San
Francisco, reviewed a wide range of
serious and life-threatening medical complications resulting from
cirrhosis during the annual UCSF
Management of the
Hospitalized Patient
conference.
Recurring complications of cirrhosis
can include ascites,
acute variceal and
Dr. Hameed
portal hypertensive bleeds, hepatic encephalopathy, bacterial peritonitis, acute renal
failure, sepsis, and a host of other
infections. In many cases, options
for treatment are limited, because
the patient develops decompensated
cirrhosis.
Poor prognosis makes it important
to urge these patients to get on a liver
transplantation list, sooner rather
than later, Dr. Hameed told hospitalists attending his small group session.
“Liver transplantation has changed
this field,” he said. “Call us to see if
your patient might be a candidate.”
“Patients do really well on transplants, with 60% survival at 10
years,” he said. He also noted that
patients with advanced, decompensated disease who do not find a place
on the transplant list might instead
be candidates for palliative care or
hospice referral.
Recurring complications of cirrhosis can include ascites,
acute variceal and portal hypertensive bleeds, hepatic
encephalopathy, bacterial peritonitis, acute renal failure,
sepsis, and a host of other infections. In many cases,
options for treatment are limited, because the patient
develops decompensated cirrhosis.
Unlike transplant lists for kidneys
and some other organs, on which
patients must wait for their turn,
liver transplants are assigned based
on need, as reflected in the patient’s
Model for End-Stage Liver Disease
(MELD) score, an objective clinical
scale derived from blood values.
Many conditions, such as infections, can still be managed with
timely treatment, returning the
patient back to baseline.
“The risk of infection is very high.
Starting antibiotics early can help,”
Dr. Hameed said.
And for conditions where fluid
volume is an issue, including spontaneous bacterial peritonitis, hypernatremia, or intrinsic renal disease,
albumin is recommended as the
evidence-based treatment of choice.
“Please don’t overtransfuse these
patients,” he said.
Jeannie Yip, MD, a nocturnist at Kaiser Foundation Hospital
in Oakland, Calif., said that she
frequently admits these kinds of
patients to her hospital. For her, Dr.
Hameed’s albumin recommendation
was the most important lesson.
“I was still using IV fluids in
patients coming in with volume
depletion, to rule out acute renal
failure. It’s always a dilemma if you
have a hypotensive patient with
low sodium and low blood pressure
who tells you, ‘I haven’t eaten for a
week,’” she explained. “It’s been hard
for me not to give them fluids. But
after listening to this talk, I see that I
should give albumin instead.”
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EDITOR’S DESK I By Danielle Scheurer, MD, MSCR, SFHM
A System of Caring?
Why I know our healthcare system will only ever be as good as the people caring within
T
Dr. Scheurer is a hospitalist
and chief quality officer at
the Medical University of
South Carolina in Charleston.
She is physician editor of
The Hospitalist. Email her at
scheured@musc.edu.
he experience I describe here is an
acute illness that my family experienced. Aside from the actual illness,
most of the story will not sound surprising or unique to most of you. It is a story
about traversing the medical system to
get care for my mom, an elderly patient
with Alzheimer’s, over the course of three
weeks. It is a story about miscommunications and fumbled handoffs, and complex
insurance and payments systems that drive
decision-making.
In this column, I aim only to describe our
experience, which was both predictable and
disappointing, within the healthcare system
that we all own.
The Background
Sheila is a 76-year-old Caucasian female with
a history of well-controlled hypertension and
hyperlipidemia and moderate-stage Alzheimer’s disease, diagnosed about six years ago.
She has resided in an assisted living facility
for about three years and is still relatively
independent in her activities of daily living
(ADLs). She has remained relatively healthy
and active despite her continuously progressive Alzheimer’s.
Her acute illness started when she developed diarrhea that was moderate in volume
and frequency. Over the course of several
days, the diarrhea significantly affected her
sleep and activities, and she became more
confused and essentially confined to her
room. By day five, she was visibly dehydrated, with dry, cracked lips and skin tenting. Her daughter, Tara, brought her to the
ED in the hospital at which her PCP was on
staff. During the eight-hour ED stay, Sheila
was rehydrated and was able to keep oral
fluids down. Her blood work was normal,
although the staff were unable to collect a
stool sample. Sheila was discharged with
instructions to see her PCP within a few
days. No one from the ED contacted the
PCP, and no one was able to set up a followup appointment.
The next day the diarrhea continued,
so Tara contacted the PCP. The office staff
noted that their next available appointment
was in five days. Tara took that appointment and continued to help her mom with
symptom management. Over the next
several days, the diarrhea continued and the
dehydration worsened again, so Tara took
her back to the same ED, where they reassured her that the labs were normal, sent a
stool sample off for testing, rehydrated her,
and sent her home again. On the discharge
paperwork, the ED physician noted that
they had “set up home health nursing” and
instructed a follow-up with Sheila’s PCP.
The next day, Tara contacted the PCP
to check on the upcoming appointment,
get advice on what to do, and see when the
home health nurse would arrive. The PCP
office confirmed the upcoming appointment in two days, told her to continue what
she was doing, and said they did not know
36
anything of the home health order and that
she should contact the ED to clarify. When
she contacted the ED, staff there told her the
PCP would have to order the home health;
Tara then called the PCP again, and he said
he could not order home health, given the
fact that he had not yet seen Sheila or her ED
record. Tara asked a logical question, “But
don’t you have the ED records? That is your
hospital, right?”
The same cycle ensued over the next few
days—now two weeks into the illness—and
Sheila started to require increasing assistance
with all of her ADLs, including toileting and
showering, along with constant supervision
to ensure hydration. The family pieced
together as much help as possible. Several
days later, on a Thursday night, the dehydration was again obvious, so Tara took her
to another ED, given the lack of assistance
received from the first two ED visits. In this
ED, after evaluation, they admitted Sheila
for observation. The family again pieced
together 24/7 coverage for the hospital stay.
The next day, Sheila continued to have diarrhea, now with vomiting. The ED hydrated
her and relieved her vomiting and diarrhea
with medications.
Because she was in observation, the hospitalist informed the family that he had written
a discharge order. The family requested more
time, given the fact that she was extremely
confused, was hallucinating, and had not kept
anything down by mouth; the hospitalist then
changed Sheila to inpatient status for ongoing care. By Saturday, the vomiting and diarrhea were much better controlled with medications, but she had not taken anything by
mouth other than a few sips of liquid. She was
given a regular diet and kept a few bites down.
The rounding hospitalist (the third in three
days) told Tara he had consulted gastroenterology but that they were no longer needed and
Sheila could be discharged. Tara requested
that they fulfill the GI consult instead of
family he strongly suspected the diarrhea
had been caused by a change to generic from
brand name, a decision that had been made
due to the cost of brand name. He recommended stopping the medication, and, if no
improvement was seen in the diarrhea within
48 hours, he would expand his workup.
The next day, a Sunday, the same hospitalist rounded early and wrote discharge
orders. When Tara’s sister, Michelle, arrived,
the nurse told her of the discharge order.
Michelle asked another logical question:
“But do we know what is wrong with her
yet? Has the diarrhea stopped?” The nurse
recounted “only a few bowel movements”
over the course of the night and no vomiting. Michelle pleaded with the nurse to at
least see if her mom could tolerate breakfast before discharge. She then talked to the
hospitalist, who recounted that Sheila had
told him that morning that she had not
had any diarrhea all night. Michelle asked
another logical question, “But you know she
has Alzheimer’s, right?”
Sheila did well with breakfast, and,
after several hours without diarrhea, she
was discharged back to her assisted living
facility with Michelle. The PCP never
called, home health was never ordered,
and the low-cost medication was still on
her discharge paperwork.
Bottom Line
Throughout all this, my sisters asked me and
others so many logical questions during the
three-week illness, such as “Don’t they review
the medication list before a patient goes
home?” and “Why didn’t the ED contact the
PCP? He works in the same hospital, right?”
Being hundreds of miles away, and knowing
both how the system should work and how
it does work, I found it sobering to see all the
typical breakdowns happening to my own
family. I felt disappointed and dismayed, but
not the least bit surprised.
Being hundreds of miles away, and
knowing both how the system should work
and how it does work, I found it sobering to
see all the typical breakdowns happening
to my own family.
discharging Sheila, given the length of time
of the illness (now almost three weeks), the
fact that she was nowhere near her baseline
status, and the lack of diagnosis.
In the meantime, when one of the nurses
from the assisted living facility called Tara
to check on Sheila, she pointed out that she
had noticed her mother’s Alzheimer’s medication “looked different” starting about three
weeks ago, which coincided with the onset
of the diarrhea. With this information, the
GI consultant took a good history, looked
at the imaging and lab testing, and told the
The one person who truly made a difference was the nurse at the assisted living facility,
who used common sense (“The medication
looks different”) and compassion (“Hi, just
calling to check on Sheila”) to help us determine what was wrong. She saved us all additional diagnostic tests and unnecessary visits.
As a chief quality officer, I talk incessantly
about systems approaches to improving
quality and safety, but while I know how
impactful reliable systems can be on good
outcomes, the system will only ever be as
good as the people caring within.
PRACTICE MANAGEMENT I By John Nelson, MD, MHM
Continuity Is King
Poor continuity of care increases overall work for your hospitalist group
I
think every hospitalist group should diligently try to maximize hospitalist-patient
continuity, but many seem to adopt
schedules and other operational practices
that erode it. Let’s walk through the issue
of continuity, starting with some history.
Dr. Nelson has been a practicing
hospitalist since 1988. He is
co-founder and past president of
SHM, and principal in Nelson Flores
Hospital Medicine Consultants. He is
co-director for SHM’s “Best Practices
in Managing a Hospital Medicine
Program” course. Write to him at
john.nelson@nelsonflores.com.
On top of what
I see as erosion
in nurse-patient
continuity, the
arrival of hospitalists disrupted
doctor-patient
continuity across
the inpatient and
outpatient setting.
Proudly carrying a pager nearly the size of a
loaf of bread and wearing a white shirt and
pants with Converse All Stars, I served as
a hospital orderly in the 1970s. This position involved things like getting patients out
of bed, placing Foley catheters, performing chest compressions during codes, and
transporting the bodies of the deceased to
the morgue. I really enjoyed the work, and
the experience serves as one of my historical
frames of reference for how hospital care has
evolved since then.
The way I remember it, nearly everyone at
the hospital worked a predictable schedule.
RN staffing was the same each day; it didn’t
vary based on census. Each full-time RN
worked five shifts a week, eight hours each.
Most or all would work alternate weekends
and would have two compensatory days
off during the following work week. This
resulted in terrific continuity between nurse
and patient, and the long length of stays
meant patients and nurses got to know one
another really well.
Continuity Takes a Hit
But things have changed. Nurse-patient
continuity seems to have declined significantly as a result of two main forces: the
hospital’s efforts to reduce staffing costs
by varying nurse staffing to match daily
patient volume, and nurses’ desire for a
wide variety of work schedules. Asking a
bedside nurse in today’s hospital whether
the patient’s confusion, diarrhea, or appetite is meaningfully different today than
yesterday typically yields the same reply.
“This is my first day with the patient; I’ll
have to look at the chart.”
I couldn’t find many research articles or
editorials regarding hospital nurse-patient
continuity from one day to the next. But
several researchers seem to have begun studying this issue and have recently published a
proposed framework for assessing it, and I
found one study showing it wasn’t correlated
with rates of pressure ulcers.1,2.
My anecdotal experience tells me continuity between the patient and caregivers
of all stripes matters a lot. Research will be
valuable in helping us to better understand
its most significant costs and benefits, but
I’m already convinced “Continuity is King”
and should be one of the most important
factors in the design of work schedules and
patient allocation models for nurses and
hospitalists alike.
While some might say we should wait
for randomized trials of continuity to
Inpatient Continuity in
Old Healthcare System
determine its importance, I’m inclined to
see it like the authors of “Parachute use to
prevent death and major trauma related to
gravitational challenge: systematic review
of randomised controlled trials.” As a ding
against those who insist on research data
when common sense may be sufficient, they
concluded “…that everyone might benefit
if the most radical protagonists of evidencebased medicine organised and participated
in a double-blind, randomised, placebocontrolled, crossover trial of the parachute.3
Continuity and Hospitalists
On top of what I see as erosion in nursepatient continuity, the arrival of hospitalists
disrupted doctor-patient continuity across
the inpatient and outpatient setting. While
there was significant concern about this
when our field first took off in the 1990s,
it seems to be getting a great deal less attention over the last few years. In many hospitalist groups I work with, it is one of the
last factors considered when creating a work
schedule. Factors that are examined include
the following:
• Solely for provider convenience, a group
might regularly schedule a provider for
only two or three consecutive daytime
shifts, or sometimes only single days;
• Groups that use unit-based hospital
(a.k.a. “geographic”) staffing might have
a patient transfer to a different attending
hospitalist solely as a result of moving to
a room in a different nursing unit; and
• As part of morning load leveling, some
groups reassign existing patients to a
new hospitalist.
I think all groups should work hard to
avoid doing these things. And while I seem
to be a real outlier on this one, I think the
benefits of a separate daytime hospitalist admitter shift are not worth the cost
of having different doctors always do the
admission and first follow-up visit. Most
groups should consider moving the admitter into an additional rounder position and
allocating daytime admissions across all
hospitalists.
One study found that hospitalist discontinuity was not associated with adverse
events, and another found it was associated with higher length of stay for selected
diagnoses.4,5 But there is too little research
to draw hard conclusions. I’m convinced
poor continuity increases the possibility
of handoff-related errors, likely results in
lower patient satisfaction, and increases
the overall work of the hospitalist group,
because more providers have to take the
time to get to know the patient.
Although there will always be some
tension between terrific continuity and a
sustainable hospitalist lifestyle—a person
can work only so many consecutive days
before wearing out—every group should
thoughtfully consider whether they are
doing everything reasonable to maximize
continuity. After all, continuity is king.
References
1. Stifter J, Yao Y, Lopez KC, Khokhar A, Wilkie DJ,
Keenan GM. Proposing a new conceptual model and
an exemplar measure using health information technology to examine the impact of relational nurse continuity
on hospital-acquired pressure ulcers. ANS Adv Nurs
Sci. 2015;38(3):241-251.
2. Stifter J, Yao Y, Lodhi MK, et al. Nurse continuity and
hospital-acquired pressure ulcers: a comparative analysis using an electronic health record “big data” set.
Nurs Res. 2015;64(5):361-371.
3. Smith GC, Pell JP. Parachute use to prevent death
and major trauma related to gravitational challenge:
systematic review of randomised controlled trials.
BMJ. 2003;327(7429):1459-1461.
4. O’Leary KJ, Turner J, Christensen N, et al. The effect of
hospitalist discontinuity on adverse events. J Hosp Med.
2015;10(3):147-151.
5. Epstein K, Juarez E, Epstein A, Loya K, Singer A.
The impact of fragmentation of hospitalist care on
length of stay. J Hosp Med. 2010;5(6):335-338.
ZERBAXA™ (ceftolozane and tazobactam) for injection, for intravenous use
BRIEF SUMMARY OF PRESCRIBING INFORMATION
See package insert for Full Prescribing Information.
INDICATIONS AND USAGE
ZERBAXA™ (ceftolozane and tazobactam) for injection is indicated for the treatment
of patients 18 years or older with the following infections caused by designated
susceptible microorganisms.
Complicated Intra-abdominal Infections ZERBAXA used in combination with
metronidazole is indicated for the treatment of complicated intra-abdominal
infections (cIAI) caused by the following Gram-negative and Gram-positive
microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella
pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis,
Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.
Complicated Urinary Tract Infections, including Pyelonephritis ZERBAXA is
indicated for the treatment of complicated urinary tract infections (cUTI), including
pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia
coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
Usage To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used
only to treat infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture and susceptibility information are available,
they should be considered in selecting or modifying antibacterial therapy. In the
absence of such data, local epidemiology and susceptibility patterns may contribute
to the empiric selection of therapy.
CONTRAINDICATIONS
ZERBAXA is contraindicated in patients with known serious hypersensitivity
to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam,
or other members of the beta-lactam class.
WARNINGS AND PRECAUTIONS
Decreased Efficacy in Patients with Baseline Creatinine Clearance of 30 to
≤50 mL/min
If CDAD is confirmed, discontinue antibacterials not directed against C. difficile,
if possible. Manage fluid and electrolyte levels as appropriate, supplement
protein intake, monitor antibacterial treatment of C. difficile, and institute surgical
evaluation as clinically indicated.
Development of Drug-Resistant Bacteria Prescribing ZERBAXA in the absence of
a proven or strongly suspected bacterial infection is unlikely to provide benefit to the
patient and risks the development of drug-resistant bacteria.
ADVERSE REACTIONS
The following serious reactions are described in greater detail in the Warnings and
Precautions section:
•
Hypersensitivity reactions
•
Clostridium difficile-associated diarrhea
Clinical Trial Experience Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and also
may not reflect rates observed in practice.
ZERBAXA was evaluated in Phase 3 comparator-controlled clinical trials of cIAI
and cUTI, which included a total of 1015 patients treated with ZERBAXA and
1032 patients treated with comparator (levofloxacin 750 mg daily in cUTI or
meropenem 1 g every 8 hours in cIAI) for up to 14 days. The mean age of treated
patients was 48 to 50 years (range 18 to 92 years), across treatment arms and
indications. In both indications, about 25% of the subjects were 65 years of age
or older. Most patients (75%) enrolled in the cUTI trial were female, and most
patients (58%) enrolled in the cIAI trial were male. Most patients (>70%) in both
trials were enrolled in Eastern Europe and were White.
The most common adverse reactions (5% or greater in either indication) occurring
in patients receiving ZERBAXA were nausea, diarrhea, headache, and pyrexia. The
table below lists adverse reactions occurring in 1% or greater of patients receiving
ZERBAXA in Phase 3 clinical trials.
Adverse Reactions Occurring in 1% or Greater of Patients Receiving ZERBAXA
in Phase 3 Clinical Trials
In a subgroup analysis of a Phase 3 cIAI trial, clinical cure rates were lower in
patients with baseline creatinine clearance (CrCl) of 30 to ≤50 mL/min compared
to those with CrCl ≥50 mL/min (see table below). The reduction in clinical cure
rates was more marked in the ZERBAXA plus metronidazole arm compared to the
meropenem arm. A similar trend was also seen in the cUTI trial. Monitor CrCl at
least daily in patients with changing renal function and adjust the dosage
of ZERBAXA accordingly.
Preferred Term
Clinical Cure Rates in a Phase 3 Trial of cIAI by Baseline Renal Function
(MITT Population)
Baseline Renal Function
ZERBAXA plus
metronidazole n/N (%)
Meropenem
n/N (%)
Normal/mild impairment
(CrCl ≥50 mL/min)
312/366 (85.2)
355/404 (87.9)
Moderate impairment
(CrCl 30 to ≤50 mL/min)
11/23 (47.8)
9/13 (69.2)
Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity
(anaphylactic) reactions have been reported in patients receiving beta-lactam
antibacterial drugs. Before initiating therapy with ZERBAXA, make careful inquiry
about previous hypersensitivity reactions to other cephalosporins, penicillins, or
other beta-lactams. If this product is to be given to a patient with a cephalosporin,
penicillin, or other beta-lactam allergy, exercise caution because cross sensitivity
has been established. If an anaphylactic reaction to ZERBAXA occurs, discontinue
the drug and institute appropriate therapy.
Clostridium difficile-associated Diarrhea Clostridium difficile-associated
diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents,
including ZERBAXA, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon and may
permit overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of
CDAD. CDAD must be considered in all patients who present with diarrhea following
antibacterial use. Careful medical history is necessary because CDAD has been
reported to occur more than 2 months after the administration of antibacterial agents.
Complicated
Intra-abdominal
Infections
Complicated Urinary
Tract Infections,
Including Pyelonephritis
ZERBAXAa
(N=482)
Meropenem
(N=497)
ZERBAXAa
(N=533)
Levofloxacin
(N=535)
Nausea
38 (7.9)
29 (5.8)
15 (2.8)
9 (1.7)
Headache
12 (2.5)
9 (1.8)
31 (5.8)
26 (4.9)
Diarrhea
30 (6.2)
25 (5)
10 (1.9)
23 (4.3)
Pyrexia
27 (5.6)
20 (4)
9 (1.7)
5 (0.9)
Constipation
9 (1.9)
6 (1.2)
21 (3.9)
17 (3.2)
Insomnia
17 (3.5)
11 (2.2)
7 (1.3)
14 (2.6)
Vomiting
16 (3.3)
20 (4)
6 (1.1)
6 (1.1)
Hypokalemia
16 (3.3)
10 (2)
4 (0.8)
2 (0.4)
ALT increased
7 (1.5)
5 (1)
9 (1.7)
5 (0.9)
AST increased
5 (1)
3 (0.6)
9 (1.7)
5 (0.9)
Anemia
7 (1.5)
5 (1)
2 (0.4)
5 (0.9)
Thrombocytosis
9 (1.9)
5 (1)
2 (0.4)
2 (0.4)
Abdominal pain
6 (1.2)
2 (0.4)
4 (0.8)
2 (0.4)
Anxiety
9 (1.9)
7 (1.4)
1 (0.2)
4 (0.7)
Dizziness
4 (0.8)
5 (1)
6 (1.1)
1 (0.2)
Hypotension
8 (1.7)
4 (0.8)
2 (0.4)
1 (0.2)
Atrial fibrillation
6 (1.2)
3 (0.6)
1 (0.2)
0
Rash
8 (1.7)
7 (1.4)
5 (0.9)
2 (0.4)
The ZERBAXA for injection dose was 1.5 g intravenously every 8 hours, adjusted to match renal
function where appropriate. In the cIAI trials, ZERBAXA was given in conjunction with metronidazole.
a
Treatment discontinuation due to adverse events occurred in 2.0% (20/1015) of
patients receiving ZERBAXA and 1.9% (20/1032) of patients receiving comparator
drugs. Renal impairment (including the terms renal impairment, renal failure, and
renal failure acute) led to discontinuation of treatment in 5/1015 (0.5%) subjects
receiving ZERBAXA and none in the comparator arms.
Increased Mortality
In the cIAI trials (Phase 2 and 3), death occurred in 2.5% (14/564) of patients
receiving ZERBAXA and in 1.5% (8/536) of patients receiving meropenem. The
causes of death varied and included worsening and/or complications of infection,
surgery and underlying conditions.
Less Common Adverse Reactions
The following selected adverse reactions were reported in ZERBAXA-treated
subjects at a rate of less than 1%:
Cardiac disorders: tachycardia, angina pectoris
Gastrointestinal disorders: ileus, gastritis, abdominal distension, dyspepsia, flatulence,
ileus paralytic
General disorders and administration site conditions: infusion site reactions
Infections and infestations: candidiasis, oropharyngeal, fungal urinary tract
infection
Investigations: increased serum gamma-glutamyl transpeptidase (GGT), increased
serum alkaline phosphatase, positive Coombs test
Metabolism and
hypophosphatemia
nutrition
disorders:
hyperglycemia,
hypomagnesemia,
Day 60 male pups at maternal doses of greater than or equal to 300 mg/kg/day.
The plasma exposure (AUC) associated with the NOAEL dose of 100 mg/kg/day
in rats is approximately 0.4 fold of the mean daily human ceftolozane exposure in
healthy adults at the clinical dose of 1 gram thrice-daily. In an embryo-fetal study
in rats, tazobactam administered intravenously at doses up to 3000 mg/kg/day
(approximately 19 times the recommended human dose based on body surface
area comparison) produced maternal toxicity (decreased food consumption and
body weight gain) but was not associated with fetal toxicity. In rats, tazobactam
was shown to cross the placenta. Concentrations in the fetus were less than or
equal to 10% of those found in maternal plasma. In a pre-postnatal study in rats,
tazobactam administered intraperitoneally twice daily at the end of gestation and
during lactation (Gestation Day 17 through Lactation Day 21) produced decreased
maternal food consumption and body weight gain at the end of gestation and
significantly more stillbirths with a tazobactam dose of 1280 mg/kg/day
(approximately 8 times the recommended human dose based on body surface
area comparison). No effects on the development, function, learning or fertility of
F1 pups were noted, but postnatal body weights for F1 pups delivered to dams
receiving 320 and 1280 mg/kg/day tazobactam were significantly reduced 21
days after delivery. F2-generation fetuses were normal for all doses of tazobactam.
The NOAEL for reduced F1 body weights was considered to be 40 mg/kg/day
(approximately 0.3 times the recommended human dose based on body surface
area comparison).
Nursing Mothers It is not known whether ceftolozane or tazobactam is excreted in
human milk. Because many drugs are excreted in human milk, exercise caution
when administering ZERBAXA to a nursing woman.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Nervous system disorders: ischemic stroke
Renal and urinary system: renal impairment, renal failure
Respiratory, thoracic and mediastinal disorders: dyspnea
Skin and subcutaneous tissue disorders: urticaria
Vascular disorders: venous thrombosis
DRUG INTERACTIONS
No significant drug-drug interactions are anticipated between ZERBAXA and
substrates, inhibitors, and inducers of cytochrome P450 enzymes (CYPs).
USE IN SPECIFIC POPULATIONS
Pregnancy - Pregnancy Category B. There are no adequate and well-controlled
trials in pregnant women with either ceftolozane or tazobactam. Because animal
reproduction studies are not always predictive of human response, ZERBAXA
should be used during pregnancy only if the potential benefit outweighs the
possible risk. Embryo-fetal development studies performed with intravenous
ceftolozane in mice and rats with doses up to 2000 and 1000 mg/kg/day,
respectively, revealed no evidence of harm to the fetus. The mean plasma
exposure (AUC) values associated with these doses are approximately 7 (mice)
and 4 (rats) times the mean daily human ceftolozane exposure in healthy adults
at the clinical dose of 1 gram thrice-daily. It is not known if ceftolozane crosses
the placenta in animals. In a pre-postnatal study in rats, intravenous ceftolozane
administered during pregnancy and lactation (Gestation Day 6 through Lactation
Day 20) was associated with a decrease in auditory startle response in postnatal
Geriatric Use Of the 1015 patients treated with ZERBAXA in the Phase 3 clinical
trials, 250 (24.6%) were 65 years or older, including 113 (11.1%) 75 years or
older. The incidence of adverse events in both treatment groups was higher in older
subjects (65 years or older) in the trials for both indications. In the cIAI trial, cure
rates in the elderly (age 65 years and older) in the ceftolozane and tazobactam plus
metronidazole arm were 69/100 (69%) and in the comparator arm were 70/85
(82.4%). This finding in the elderly population was not observed in the cUTI trial.
ZERBAXA is substantially excreted by the kidneys and the risk of adverse reactions
to ZERBAXA may be greater in patients with impaired renal function. Because
elderly patients are more likely to have decreased renal function, care should be
taken in dose selection and it may be useful to monitor renal function. Adjust
dosage for elderly patients based on renal function.
Patients with Renal Impairment Dosage adjustment is required in patients
with moderate (CrCl 30 to 50 mL/min) or severe (CrCl 15 to 29 mL/min) renal
impairment and in patients with ESRD on HD.
OVERDOSAGE
In the event of overdose, discontinue ZERBAXA and provide general supportive
treatment. ZERBAXA can be removed by hemodialysis. Approximately 66% of
ceftolozane, 56% of tazobactam, and 51% of the tazobactam metabolite M1
were removed by dialysis. No information is available on the use of hemodialysis
to treat overdosage.
Copyright © 2015 Merck Sharp & Dohme Corp.,
a subsidiary of Merck & Co., Inc.
All rights reserved. Revised: May 2015
AINF-1150692-0001 09/15
Learn more at www.ZERBAXA.com
Indications and Important Safety Information
Indications
ZERBAXA is indicated in adult patients for the treatment of complicated urinary tract infections
(cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms:
Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
ZERBAXA used in combination with metronidazole is indicated in adult patients for the
treatment of complicated intra-abdominal infections (cIAI) caused by the following Gram-negative
and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca,
Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis,
Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other
antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered
in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.
Important Safety Information
•
•
Patients with renal impairment: Decreased efficacy of ZERBAXA has
been observed in patients with baseline creatinine clearance (CrCl) of
30 to ≤50 mL/min. In a clinical trial, patients with cIAIs with CrCl
≥50 mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA
plus metronidazole vs 87.9% when treated with meropenem. In the same
trial, patients with CrCl 30 to ≤50 mL/min had a clinical cure rate of
47.8% when treated with ZERBAXA plus metronidazole vs 69.2% when
treated with meropenem. A similar trend was also seen in the cUTI trial.
Monitor CrCl at least daily in patients with changing renal function and
adjust the dose of ZERBAXA accordingly.
Hypersensitivity: ZERBAXA is contraindicated in patients with known
serious hypersensitivity to ceftolozane/tazobactam, piperacillin/
tazobactam, or other members of the beta-lactam class. Serious and
occasionally fatal hypersensitivity (anaphylactic) reactions have been
reported in patients receiving beta-lactam antibacterials. Before initiating
therapy with ZERBAXA, make careful inquiry about previous
hypersensitivity reactions to cephalosporins, penicillins, or other betalactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use
and institute appropriate therapy.
•
Clostridium difficile–associated diarrhea (CDAD), ranging from
mild diarrhea to fatal colitis, has been reported with nearly all systemic
antibacterial agents, including ZERBAXA. Careful medical history is
necessary because CDAD has been reported to occur more than 2 months
after the administration of antibacterial agents. If CDAD is confirmed,
antibacterial use not directed against C. difficile should be discontinued,
if possible.
•
Development of drug-resistant bacteria: Prescribing ZERBAXA in the
absence of a proven or strongly suspected bacterial infection is unlikely to
provide benefit to the patient and increases the risk of the development of
drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions occurring in ≥5% of patients were
headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea (6.2%),
and pyrexia (5.6%) in the cIAI trial.
Please see Brief Summary of Full Prescribing Information
on the following pages.
Copyright © 2015 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved. AINF-1150692-0001 09/15 zerbaxa.com

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