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connectionOctober 2014 Volume 38, Issue 9
the Official Magazine of the Emergency Nurses Association
SafekeepingEXPANDING THE WAYS WE CAN PROTECT PATIENTS YOUNG AND OLD — AND OURSELVES
♦ Day of Dialogue on ED Violence 8
♦ Looking Out For Child Passengers 12
♦ Rethinking Elderly Transitions of Care 36
WORKPLACE VIOLENCE PREVENTIONKNOW YOUR WAY OUT: RECOGNIZE, AVOID, PREVENT AND MITIGATE EMERGENCY DEPARTMENT VIOLENCE
WORKPLACE VIOLENCE PREVENTIONKNOW YOUR WAY OUT: RECOGNIZE, AVOID, PREVENT AND MITIGATE EMERGENCY DEPARTMENT VIOLENCE
Interactive, online course designed to mitigate violence in the emergency department. Nurses, managers, and staff who work in emergency care settings will learn to:¡ Recognize risk factors¡ Apply prompt and appropriate responses¡ Implement organizational prevention strategies¡ Report and analyze patterns of violence
2 Hour Course ¡ Video Demonstrations ¡ 1.13 Contact HoursInteractive Quizzes ¡ Developed by ENA with a grant from OSHA
Violence is not part of the job—Protect Yourself!Go to www.ena.org/workplaceviolence
The Emergency Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credential Center’s Commission on Accreditation.
This material was produced under grant number SH-23534-12-60-F-17 from the Occupational Safety and Health Administration, U.S. Department of Labor. It does not necessarily re�ect the views or policies of the U.S. Department of Labor, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
WORKPLACE VIOLENCE PREVENTIONKNOW YOUR WAY OUT: RECOGNIZE, AVOID, PREVENT, AND MITIGATE EMERGENCY DEPARTMENT VIOLENCE
Workplace Violent Prevention Ad_Connection_Full_08 2014_print.pdf 1 7/24/14 12:55 PM
‘Hey, Can I Grab You For a Second?’
FROM THE PRESIDENT | Deena Brecher, MSN, RN, APN, ACNS-BC, CEN, CPEN
You are in the medication room,
making an insulin drip for a 12-year-
old patient in diabetic ketoacidosis.
The charge nurse comes into the
room to let you know the OR is ready
for your patient with appendicitis.
You are reviewing a medication
order for a patient. You need some
clarity about the order, as you are
not sure the dose is correct for the
patient. You walk toward the
physician, who is getting sign-out
from a resident, saying, ‘‘Hey, can I ask you
a question?’’
In the ED, we are constantly balancing a
need for information and communication
with tasks and responsibilities. Have you
ever considered that the where, when and
how of seeking out that information impacts
patient safety? Take the patient with
abdominal pain. You have made your
mental task list before walking out of the
room. Within 45 seconds, your thoughts are
interrupted when you are asked about
lunch. Now, trust me, making sure you get
to lunch is incredibly important, not only to
maintain adequate glucose levels to the
brain but to take a much-needed break.
However, how easy is it for you to recover
from that interruption? Is it possible you
forgot what questions you need to ask? Is it
possible one thing might have fallen off your
list of things to do? Is it possible you forgot
what your patient’s blood glucose result
was? By not doing what you forgot to do, is
it possible the patient can be harmed?
There is much evidence that identifies the
ED as a place where distractions and
interruptions are prevalent. There is also
evidence to show that interruptions during
the medication preparation and delivery
processes can lead to serious errors.
How is your emergency department
working to limit distractions and
interruptions? Do you have ‘‘distraction-free’’
zones in your department? Can you create
‘‘sterile cockpit’’ environments where
interruptions are unacceptable? Medication
rooms are one place that should be
interruption-free. What about where we are
discussing important patient information?
How many times have you interrupted a
conversation about patient care to ask a
noncritical question? Do we need to
Dates to Remember
PAGE 4Free CE of the MonthMembers in Motion
PAGE 9Letters to the Editor
PAGE 30Board Writes
PAGE 35Future of Your Nursing
Regular Features
Oct. 7-11, 2014 ENA 2014 Annual Conference, Indianapolis
PAGE 6Update From the Executive Director
PAGE 8ENA, AONE Hold a Day of Dialogue on Workplace Violence
PAGE 10A Trip Through the ENA Archives
PAGE 12Your Role in Child Passenger Safety
PAGE 14Medical Errors Are on Senate’s Radar
PAGE 16ED Getting a Helping Hand From a Suicide Crisis Center
PAGE 23Focused State and Chapter Leaders Orientation Coming to Las Vegas
PAGES 24 - 29ENA Foundation Scholarship and Research Grant Award Recipients
PAGE 32The Wisdom in Nursing Stories
PAGE 34Game-Changing Votes Are Out There For ENA Elections
PAGE 36Michigan ED Plugs the Gaps in Transitions of Care for the Elderly
PAGES 38 - 43Committee Reports: ENA Lantern Award, Past Presidents and Technology
ENA Exclusives
Y ou are at the bedside caring for a patient with abdominal pain.
This patient has a history of colon cancer, diabetes and
hypertension. The patient has questions about the plan of care, and
you need to speak to the physician to get the answers. The patient is
also hyperglycemic and needs insulin coverage.
You walk out of the room with a list of questions, tasks and interventions to accomplish.
As you are walking toward the team station, you are stopped by a peer asking what time you
would like to go to lunch.
Continued on page 9
Official Magazine of the Emergency Nurses Association 3
Congratulations and appreciation to all emergency nurses from the ENA Board
of Directors in celebration of
Emergency Nurses Week Oct. 5 - 11
Emergency Nurses Day Oct. 8
In celebration
of Emergency Nurses
Week and Emergency
Nurses Day this month,
ENA is giving you not one
but two new free continuing education courses as
part of our catalog of offerings.
Available to you starting Oct. 1 . . .‘‘Shift Work Disorder: Are You At Risk?’’, presented
by Mary Alice Vanhoy, MSN, RN, CEN, CPEN,
NREMT-P. This
session explores
shift work disorder,
its impact on
practice and
strategies for
mitigating it.
‘‘Difficult Airway
Response Teams
(DARTs) in the Hospital Setting,’’ presented by
Michael J. Chicarelli, MSN, RN, CEN. Learn about the
basics of DARTs and DART alerts, along with the
benefits, equipment costs and challenges that come with
implementing DARTs.
To take these and other eLearning courses free as an
ENA member:
• Go to www.ena.org/freeCE, where you’ll log in
as a member (or create an account).
• Add desired courses to your cart and select
‘‘check out.’’
• Proceed to your Personal Learning Page to start or
complete any course for which you have
registered or to print a final certificate.
• To return to your Personal Learning Page later, go
to www.ena.org and find ‘‘Go to Personal
Learning Page’’ under the Education tab.
Be sure you are using the e-mail address associated
with your membership when logging in. If you have
questions about any free eLearning course or the
checkout process, e-mail [email protected].
ENA Connection is published 11 times per year from January to December by: The Emergency Nurses Association
915 Lee Street Des Plaines, IL 60016-6569
and is distributed to members of the association as a direct benefit of membership. Copyright ©2014 by the Emergency Nurses Association. Printed in the U.S.A.Periodicals postage paid at the Des Plaines, IL, Post Office and additional mailing offices.
POSTMASTER: Send address changes to ENA Connection915 Lee StreetDes Plaines, IL 60016-6569ISSN: 1534-2565Fax: 847-460-4002 Website: www.ena.orgE-mail: [email protected]
Non-member subscriptions are available for $50 (USA) and $60 (foreign). For editorial inquiries, e-mail [email protected]
Publisher:Kathy Szumanski, MSN, RN, NE-BCEditor-in-Chief:Amy Carpenter AquinoAssociate Editor:Josh GabySenior Writer:Kendra Y. Mims
BOARD OF DIRECTORSOfficers:President:
Deena Brecher, MSN, RN, APN, ACNS-BC, CEN, CPEN
President-elect: Matthew F. Powers, MS, BSN, RN, MICP, CEN
Secretary/Treasurer: Kathleen E. Carlson, MSN, RN, CEN, FAEN
Immediate Past President: JoAnn Lazarus, MSN, RN, CEN
Directors:
Ellen (Ellie) H. Encapera, RN, CENMitch Jewett, AA, RN, CEN, CPEN Michael D. Moon, PhD, MSN, RN,
CNS-CC, CEN, FAENSally K. Snow, BSN, RN, CPEN, FAENJeff Solheim, MSN, RN-BC, CEN,
CFRN, FAENJoan Somes, PhD, MSN, RN-BC, CEN,
CPEN, FAEN, NREMT-PKaren K. Wiley, MSN, RN, CEN
Executive Director: Susan M. Hohenhaus, LPD, RN, CEN, FAEN
Member Services: 800-900-9659
Kentucky ENA Names 2014 Emergency Nurse of the YearThe Kentucky ENA State Council honored Meg Candage, BSN, RN,
CFRN, as its emergency nurse of the year, presenting her with the
second annual Cheryl L. Westbay Award for
Emergency Nursing Excellence at its annual
educational conference in London, Ky., in May.
Candage, the current Kentucky ENA treasurer and
2012 president of the Bluegrass Chapter, works in
the education department at Georgetown
Community Hospital in Georgetown, Ky., and as a
flight nurse for Air
Care at the University
of Cincinnati.
The first Cheryl L.
Westbay Award was
presented in 2013 to
Linda J. Murray, RN,
CEN, CPEN, a staff
development
instructor in the
University of Kentucky
HealthCare emergency
department.
Meg Candage
More Members in Motion, page 7
Do you have a recent professional or educational success story you want to share about yourself or an ENA member colleague? Have you won an award or earned a promotion? Has another member you know been recognized for outstanding work?
Tell us! Send an e-mail to [email protected] with the subject line “Members in Motion.” Be sure to include names, credentials and, if applicable, photos of the nurse(s) being recognized. ENA staff may follow up with you for additional details.
Candage receives the Award for Emergency Nursing Excellence from Cheryl L. Westbay.
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Visit us at the ENA Show at Booth #413
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ENA ad_Layout 1 8/5/14 11:27 AM Page 1
6 October 2014
UPDATE FROM THE EXECUTIVE DIRECTOR | Susan M. Hohenhaus, LPD, RN, CEN, FAEN
Strength in the 2nd QuarterDear ENA Members,
As always, ENA
staff remains focused on
the work that supports
its members. Here is an
overview of the health and well-being of ENA
at the end of the second quarter of 2014:
♦ ENA’s Government Relations staff focused
on the following federal issues in the second quarter of
2014: trauma care legislation, EMS for Children, the
Pedestrian Safety Act and support for nurses in the VA
system. At the state level, ENA GR staff assisted Louisiana in
becoming the 31st state to make assault against an
emergency nurse a felony, assisted the California ENA State
Council with finding a sponsor for a similar bill that is
expected to be introduced in 2015 and assisted the Illinois
ENA State Council in preventing poison centers from closing.
ENA’s EN411 program increased by 66 members in Q2; 145
members took action to 445 offices on Capitol Hill for EMSC
— the largest response to an action alert. Ninety-nine ENA
members attended Day on the Hill, up from 77 in 2013. GR
staff also worked with the National Association of EMTs and
the American Academy of Critical-Care Nurses on air medical
safety rules being recommended by the Federal Aviation
Administration.
♦ ENA’s marketing team has been extremely busy,
evidenced by the fact that our social media presence
continues to grow. Our largest presence is on Facebook,
where we achieved more than 29,000 ‘‘likes’’ on our main
ENA page in the first half of 2014.
Web Presence
• Web traffic increased by about 30,000 unique visitors.
• Time spent per visit increased slightly.
• New visitors increased by approximately 4 percent.
• Mobile usage increased by 6 percent.
• While e-mail open rates are down approximately
6 percent, the click-through rates are up by almost
1 percent, which we believe means content is relevant.
Social Media
• Our number of followers has increased by approximately
2,400 (Q1: 30,132; Q2: 32,520).
• Impressions for Q2 have more than doubled since Q1
(Q1: 267,000; Q2: 429,750). This shows our message is
resonating and expanding to a wider audience by
spreading virally.
♦ ENA’s Market Research staff has
completed several studies, including
surveys of Academy of Emergency
Nursing members, election
candidates and conference and Day
on the Hill attendees.
♦ ENA’s Institute for Emergency
Nursing Education (IENE) continues to monitor our
courses, manage the ANCC Continuing Nursing Education
units and maintain the free CE process for our members’
benefit. Three courses were deployed in Q2 2014.
♦ ENA’s Institute for Emergency Nursing Research
(IENR) has several studies on target, including studies on
discharge criteria for patients receiving narcotics; acuity
assignment; fatigue and cognitive ability; and moral distress
in emergency nurses.
♦ ENA’s Institute for Quality, Safety and Injury
Prevention (IQSIP) completed the fourth cycle of the
Lantern Award program. Staff has been assisting member
work teams and committees in the creation of several
products, including topic briefs and position statements.
♦ Course Operations: Trauma Nursing Core Course 7th
edition is on target with 2,410 provider courses and 138
instructor courses in Q2. There were 7,731 attendees at
provider courses and 248 attendees at instructor courses.
Emergency Nursing Pediatric Course had 911 provider
courses with 2,334 attendees and 67 instructor courses with
78 attendees.
♦ Membership: ENA’s membership at the end of Q2 2014
was 40,443, compared to 40,059 at the end of Q2 2013.
♦ Finances: The second quarter continued to yield healthy,
vibrant financial results. Revenue is up 10 percent from
2013, and while expenses are 7 percent higher than in 2013,
we are managing them well at 8 percent better than budget.
Total investment income as of June 30 was $754,000.
As always, we thank our members for their support,
encouragement and thoughtful feedback of ENA’s processes
and programs and look forward to a productive second half
of 2014.
Official Magazine of the Emergency Nurses Association 7
Minneapolis ED Determined to Drop Pounds TogetherEmergency department staff at the University of Minnesota
Medical Center–East Bank in Minneapolis recently took
part in an ‘‘en masse’’ weight-loss challenge organized by
ENA member Erica Myking, RN, CEN, CPEN, to see who
could lose the highest BMI percentage over 12 weeks.
Each participant contributed $5 into a pot to be awarded
to the first-place winner. Weights were reported on the
honor system every other Monday and communicated via
e-mail. Along the way, Myking provided tips, recipes and
motivating quotes.
Among 15 other participants who finished the challenge
were ENA members Pete Benolken, MSN, CEN, CPEN;
Molly Delaney, PhD, RN, CEN, CPEN; Lisa Wright,
MA, RN, CEN; and Sandra Fonkert, MSN, CEN, CPEN, a
member of ENA’s Peer Review Education Committee, who
took second place. Participants lost 116.5 pounds combined.
A second challenge began Sept. 2 because the first was
so well-received.
‘‘This was a great activity for our department to do
together because everyone could participate,’’ Myking said.
‘‘When you work in a department that runs 24/7, it can be
difficult to get people together for any sort of extracurricular
activities because everybody’s schedules are so crazy. Having
the challenge be ‘on your honor’ so nobody had to ever
drive in to do a weigh-in made it easy for everyone to
participate.’’
Christina M. Weaver, MSN, RN, CEN, of the
Cardinal Chapter of North Carolina, was
elected to a four-year term on the North
Carolina Board of Nursing from January 2015
to December 2018.
‘‘I am looking forward to my service and am proud to
say I am also a member of ENA,” Weaver wrote.
Kathy Lebowitz, MSN, RN, CEN, is the 2014
recipient of the Alumni Nurse Leader Award
from Mount St. Joseph University near
Cincinnati. Lebowitz, the emergency
department manager at Bethesda Butler
Hospital Emergency Department in Hamilton, Ohio, also
recently became certified as an advanced nurse executive.
Debora La Torre, BSN, RN, received the Clinical Excellence
Award at New Jersey ENA’s annual Emergency Care
Conference. Other award winners from the conference were
listed in the August issue of ENA Connection.
Continued from page 4
Emergency nurses cannot solve the
problem of violence in the
emergency department by themselves.
On July 14-15, members of ENA and
the American Organization of Nurse
Executives held a day of dialogue in
Chicago to discuss workplace violence
and how the organizations can partner
to provide solutions.
The following ENA members and
staff represented the association: Deena
Brecher, MSN, RN, APN, ACNS-BC,
CEN, CPEN, 2014 president; JoAnn
Lazarus, MSN, RN, CEN, immediate past
president; Susan M. Hohenhaus, LPD,
RN, CEN, FAEN, executive director;
Kathy Szumanski, MSN, RN, NE-BC,
deputy executive director for nursing;
Lisa Wolf, PhD, RN, CEN, FAEN,
director of the Institute for Emergency
Nursing Research; Kristine Powell,
MSN, RN, CEN, NEA-BC, corporate
director of emergency services for
Baylor, Scott & White Emergency
Services-North Texas; and Sean Elwell,
MSN, RN, EMT-B, trauma program
manager and interim ED manager at
the Alfred I. DuPont Hospital for
Children in Wilmington, Del.
AONE was represented by Pamela
Thompson, MS, RN, CENP, FAAN, chief
executive officer of AONE and senior
vice president for nursing for the
American Hospital Association; Karen
Wray, MSN, RN-BC, NEA-BC, nursing
director, acute care, at the University of
Kansas Hospital; Reynaldo R. Rivera,
DNP, RN, NEA-BC, FAAN, director of
nursing, New York Presbyterian
Hospital; and Erik Martin, MSN, RN,
clinical director for the Pediatric
Intensive Care Unit at Cincinnati
Children’s Hospital Medical Center.
‘‘I thought it was an exciting idea to
bring together the nurse executives
with the emergency nurses,’’ said
Powell, who was invited to the day of
dialogue by Brecher. ‘‘I believe that
when the nurse executive is actively
involved and aware of the issue of
workplace violence, we can be more
proactive and more effective in dealing
with the issue itself.’’
Powell said the meeting began with
a session in which the two groups met
separately to discuss what they would
say to the other group.
‘‘If you could tell the nurse
executives whatever you want about
workplace violence, what would those
things be from the perspective of a
clinical staff nurse in the emergency
department?’’ Powell said. ‘‘And
alternately, the nurse executives were
responsible for doing the same thing.’’
Powell said that session was “very
insightful’’ because when the two
groups shared their results, the
importance of other expected issues
such as lateral violence came to the
forefront. While lateral violence, or
violence between colleagues, is usually
not physical, it is no less harmful.
‘‘Violence is violence, regardless of
who the perpetrator is,’’ Powell said.
Elwell said he appreciated the format
for the two-day meeting because it
offered a platform not only for
discussing the problems but for
formulating a plan to move forward and
establishing priorities for the two groups
in managing workplace violence.
‘‘I think there needs to be buy-in on
this from all different levels,’’ he said.
‘‘It’s definitely important for emergency
nurses, but it’s important from a
leadership standpoint, too, that there is
support for this moving forward. I
think that’s a big piece.’’
ENA continues to reach out to new
partners. On Aug. 21, members of the
International Association of Healthcare
Security and Safety visited ENA
headquarters in Des Plaines, Ill., to
share their perspective on the issue of
violence in the ED. Brecher wrote
about the meeting in the Aug. 26
edition of her ENA President’s Blog
(enapresident.wordpress.com).
Additional coverage will appear in
next month’s issue of ENA Connection.
‘‘Workplace violence is not just a
staff safety issue,’’ said Powell, who also
attended the Aug. 21 meeting. ‘‘It’s a
patient safety issue. The shared goal for
all of us is to make the environment
safer for our patients and ourselves.’’
8 October 2014
PUTTING OUR HEADS TOGETHERENA, Nursing Execs Meet For Day of Dialogue on Workplace Violence
PARTNERSHIPS
By Amy Carpenter Aquino, ENA Connection “I think there needs to be
buy-in on this from all different levels. It’s definitely important for emergency nurses, but it’s important from a leadership standpoint, too, that there is support for this moving forward.’’Sean Elwell, MSN, RN, EMT-B, ENA Representative at meeting with AONE
Kristine Powell Sean Elwell
Official Magazine of the Emergency Nurses Association 9
interrupt patient handoff to ask a question?
If the patient’s life depends on it right now, the answer is
yes. If it’s a question that needs to be asked but not critical in
this moment in time, should you be interrupting a patient care
conversation to ask it? How do we partner with the
interdisciplinary team to limit unnecessary distractions and still
engage in critical communication?
First, we need to change our own behavior. The next time
you are heading out to ask a question of a colleague, pay
attention to the task that person is engaged in. If your
colleague is obviously engaged in a critical patient task, such
as handoff or medication preparation, hold your question until
the task is complete. Then ask if it’s a good time for a question.
If you are engaged in a task and someone approaches with
a question, say, ‘‘I need to focus on this critical task. I am happy
to answer your question when I am finished.’’ By recognizing
unsafe clinical behavior in ourselves, we can change that
behavior and move closer to an error-free ED.
Read more from Deena Brecher on the ENA
President’s Blog (enapresident.wordpress.com
or QR code at left).
From the President Continued from page 3
On Aug. 26, ENA announced the appointment of Anne
Manton, PhD, PMHNP-BC, FAEN, FAAN, as editor-in-
chief of the association’s Journal of Emergency Nursing.
She had been interim editor-in-chief since September 2013.
Manton, who specializes in psychiatric and mental
health care, brings extensive emergency nursing experience
to this role, as well as decades of involvement with ENA.
She was ENA president in 1998 and previously was a
contributing editor to JEN.
‘‘As the editorial board looked at the future of JEN and
how it fits into ENA’s strategic plan, it was evident that Dr.
Manton not only has the expertise to elevate the journal
but has already made substantial contributions since she
began serving as interim editor,’’ said ENA president Deena
Brecher, MSN, RN, APN, ACNS-BC, CEN, CPEN. ‘‘Her
clinical expertise, leadership skills and involvement with
ENA provide a solid foundation for producing a journal
with the highest level of editorial excellence.’’
JEN is the official peer-reviewed journal of ENA and
reaches more emergency nurses, emergency/trauma
departments and ED managers than any other journal.
Marie Grimaldi
Look for more information about Manton’s new role in an
upcoming issue of ENA Connection.
JEN Editor-in-Chief Named
In recognition of Emergency Nurses Week, I felt
compelled to submit a letter as a celebration of all
emergency nurses and the job we all do daily without a
second thought about the impact we make on the lives of
others. A short time ago, I was moved by the circumstances
that resulted in my elementary-school-age daughter bringing
home a 30-minute video for her ‘‘Hero Classic Assignment,’’
and I wanted to share my thoughts with gratitude.
The assignment was to watch the video and reflect on
the central idea of ‘‘experiencing risk is part of being
human.’’ By complete coincidence, my daughter chose the
Florence Nightingale video. When her teacher (a nurse)
questioned her choice, she stated that she liked Florence’s
name, having no idea that she was the nurse who shaped
her mother’s professional life.
That evening found the entire family viewing the video
about this hero, Florence Nightingale, and her life as the
founder of modern nursing. The amazement in my child’s
eyes as she saw the care that Florence provided to the
soldiers and how she herself became ill created feelings of
pride in my heart. As I reflected on my years in nursing
and the patients who had been in my care, I thought of
those close to me who were choosing nursing as their
profession and found myself with tears in my eyes in
appreciation for the legacy that we all continue to uphold.
As emergency nurses, we all see more in our career than
most people see in a lifetime. But despite the critical and
dying patients, sick children, verbally inappropriate patients
and others who touch us emotionally, we continue to
perform our job without hesitation. All too often, we do not
hear words of thanks. As we celebrate Emergency Nurses
Week, it is important to take a moment to reflect on our
work and to say thank you for the care you provide, and
for being a true risk-taker. You make our specialty
profession outstanding, and there is nothing trivial about
your impact on the lives of others. As Florence Nightingale
once said, ‘‘Live life when you have it. Life is a splendid gift
— there is nothing small about it.’’
Mary Cain, BSN, RN, CEN,
Emergency Department Staff Nurse,
St. Anthony Hospital, Lakewood, Colo.
ENA Connection welcomes letters from members. Letters should address content previously published in the magazine. Letters may be edited for space and clarity. Submission does not guarantee publication. Please include your name, credentials and contact information for verification. Send letters to [email protected].
October 201410
ENA ARCHIVES
T he ENA Collection is a
comprehensive history of the
association that consists of seven
boxes containing original
correspondence from ENA founders
Anita Dorr, RN, FAEN, and Judith C.
Kelleher, RN, MSN, CEN, FAEN, along
with other donated historical items. It’s
housed at the Eleanor Crowder Bjoring
Center for Nursing Historical Inquiry,
which was established at the University
of Virginia School of Nursing in 1991
to acquire nursing materials and
preserve nursing history.
ENA’s volunteer historian, Joanne
Fadale, BSN, RN, FAEN, and ENA staff
archivist Laura Peter took their first
visit to the Bjoring Center in August.
The primary purpose was to verify the
materials donated to the collection and
confirm how many of the documents
were original as opposed to copies.
After a full day of examining the
contents of the boxes — archived in
the Claude Moore Health Sciences
Library — Fadale found an estimated
80 percent of the documents were
originals. Archived items included
letters, minutes, reports, a cloth patch
displaying ENA’s first mascot and logo
(the Roadrunner), the first Emergency
Department Nurses Association
national conference program and
volumes of ENA Connection and ENA
Daily News.
Fadale said she didn’t realize how
many people were involved in forming
ENA until she went through the
collection. She discovered numerous
letters between Dorr and ENA past
president Marion Dover, RN, and
would like to see original
correspondence from other past
presidents included, as well as the
history of the first Trauma Nursing
Core Course and Emergency Nursing
Pediatric Course.
‘‘I don’t think we need to send
everything, but I think we need to
include how we got funding for the
first TNCC and ENPC,’’ Fadale said.
‘‘Those things are significant because
when you do a project like that, there
are people involved and funding.’’
The library where the collection is
housed has historical nursing books and
artifacts on display, including a nursing
student uniform similar to the one
Fadale wore more than 40 years ago.
‘‘They had just about every book on
nursing history and nursing from all
parts of the world — you could just sit
there for hours and read,’’ Fadale said.
‘‘They have a nice collection of their
own historical artifacts. They also have
a window display, currently of the year
1906. They have appropriate
newspaper articles on the diseases of
that time, like influenza. The display
shows a child going to the hospital
with their mother, and it shows a
nurse. It was all done in appropriate
clothing for that time.’’
Fadale said she was impressed with
the care the University of Virginia took
with the ENA Collection.
‘‘They organized the collection so
How the Archiving Project Came to BeAt its July 2004 meeting, the ENA Board of Directors approved a proposal to donate records related to the foundation and formation of ENA to the Eleanor Crowder Bjoring Center for Nursing Historical Inquiry at the University of Virginia School of Nursing. The initial donation was made at a dedication ceremony on Sept. 28, 2005.
By Kendra Y. Mims, ENA Connection
ENA volunteer historian Joanne Fadale, BSN, RN, FAEN, and staff archivist Laura Peter stand with the seven-box ENA Collection they went through in August at the Eleanor Crowder Bjoring Center for Nursing Historical Inquiry in Charlottesville, Va.
Seeing What’s in StoreTrip to Review Collection Confirms ENA Treasures
well that we didn’t have to dig
through,’’ she said. A meeting with the
center’s director, Arlene W. Keeling,
PhD, RN, FAAN, provided insight into
what ENA actually should be saving.
Fadale’s favorite part of the trip was
reviewing old documents that she had
seen at one point in her life.
‘‘Most of those documents came
from my chapter,’’ she said. ‘‘In 1985,
we found all of these documents after
one of our former state presidents
passed away. She had all Anita’s old
documentation, and we gave it to the
national president in a binder. Those
are the only copies that we have of
those. It tickled my heart knowing that
I had put my fingers on these pieces of
paper before.’’
For more on the ENA Collection
and to view a list of the contents, visit
tinyurl.com/
ENACollection or scan
the QR code at left.
Official Magazine of the Emergency Nurses Association 11
Demonstrate your commitment to excellence and professional advancement; earn a Board of Certification for Emergency Nursing (BCEN®) specialty certification.
Visit www.BCENcertifications.org to learn more.g Certified Emergency Nurse (CEN®)g Certified Flight Registered Nurse (CFRN®)g Certified Pediatric Certified Nurse (CPEN®)g Certified Transport Registered Nurse (CTRN®)
Visit BCEN at ENA Annual 2014 | Booth#339
You already have the expertise. It’s time to get certified.You already have the expertise. It’s time to get certified.
Among other nursing items on display at the Bjoring Center’s Claude Moore Health Sciences Library: a quilt honoring the profession and an old uniform of the type once worn by student nurses.
October 201412
Alarming statistics show that
preventable injuries are the No. 1
killer of children in the United States
and that U.S. emergency departments
treat almost 9 million pediatric patients
for injuries every year.
The National Child Passenger Safety
Certification Training program attempts
to reduce that by raising awareness
and educating communities and
families about child safety on the road.
The State Farm-sponsored program
certifies child passenger safety
technicians and instructors. More than
131,000 people have completed the
certification course since 1997,
including 36,000 currently certified CPS
technicians. CPS technicians contribute
to improving children’s safety by
conducting child car seat checks,
providing families with hands-on
instructions on how to install seats and
safety belts properly and educating
parents on what they can do to
prevent injuries.
Meanwhile, Safe Kids Worldwide is
an organization committed to
protecting children from unintentional
injuries through advocacy, research,
education and awareness programs. As
the CPS certification specialist for Safe
Kids Worldwide, Kim Herrmann travels
nationally, developing continuing
education opportunities to help CPS
technicians maintain their certification.
‘‘It’s a two-year certification,’’
GET CERTIFIED, EARN CE CREDITUpon successful completion of the National Child Passenger Safety Certification Training course, ENA will provide 23.75 contact hours. In order for nurses attending a certification course to receive 23.75 nursing contact hours (6.91 Pediatric designation), the lead instructor must follow the requirements detailed in the checklist (tinyurl.com/LeadInstructorChecklist or QR code below). Course documentation
must be maintained for six years.
ENA is accredited as a provider of continuing
nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
For questions regarding any details for contact hours, please email the CNE unit with your questions at [email protected].
TECH SUPPORTEmergency Nurses Encouraged to Take the Wheel on Child Passenger Safety as Certified TechniciansBy Kendra Y. Mims, ENA Connection
INJURY PREVENTION
Official Magazine of the Emergency Nurses Association 13
Herrmann said. ‘‘We’ve been able to
really increase the quality, as well as
the numbers of certified technicians.
They come from a background of not
only hospital-based programs, but also
firefighters, EMS personnel, law
enforcement and public health. Many
people who want to be advocates for
children come from a lot of different
walks of life. Many people, like first
responders, are frustrated when there
is a crash-related injury and it could
have been prevented had the child
been properly secured in an
appropriate car seat.’’
Herrmann said almost half of the
36,000 certified CPS technicians are
from the health field (hospital/medical
personnel make up 19 percent and
rescue/EMS personnel 28 percent). She
actively searches for ways to promote
the importance of CPS certification.
‘‘Children really do not have the
capability of protecting themselves,’’
she said. ‘‘We treat them, we try to
help them recuperate, but it takes the
family to do that. If we had a way of
connecting emergency nurses
to families to help them
understand that there is more
that can be done to protect
their children and keep them
safer, I think the emergency
nurse would have a big role
in that.’’
ENA member and National
Child Passenger Safety Board
member Thelma Kuska, BSN,
RN, CEN, FAEN, has
long been a proponent
of emergency nurses
becoming certified CPS
technicians.
‘‘Should all
emergency nurses be
certified technicians? It
would be nice, but the
reality is they do not all have to be
certified,’’ said Kuska, who has been
involved in child passenger safety for
more than 15 years. ‘‘But all of them
should have the correct information so
that they can provide the correct
discharge instructions to parents and
caregivers.’’
“Emergency nurses are in a very
unique position to influence the
parents because of the teachable
moments in the ED,’’ Kuska added.
‘‘We see the victims of car crashes and
know their injuries. Routine encounters
with young children and their parents
provide excellent opportunities for
assessing car seat and booster seat use.
Emergency nurses are also in a unique
position to educate
parents and caregivers
on how to keep
children safe while
traveling in motor
vehicles. Routine
encounters in the
emergency department
provide a perfect setting
for this educational opportunity.’’
The CPS Technician Certification
Course is three to four days of
classroom instruction with hands-on
skill assessments, written quizzes and a
community safety seat checkup event.
Highlights of the course include
learning about the different parts of the
car seat, how to read instructions, how
to install car seats in different vehicles
and the basics of injury prevention.
Nurses can earn contact hours for
completing the national course.
‘‘Nurses would also learn about
some of the technology involved in the
vehicles and car seats, so we can point
those out to families and provide
guidance to families,’’ Kuska said. ‘‘We
can also make sure their current
data is appropriate for the age
and weight of their child, and it
fits them properly.’’
Safe Kids Worldwide
continues to raise awareness
and promote CPS technician
certification through initiatives
such as the nationally
recognized Child Passenger
Safety Week in September and
partnering with advocacy
agencies to help families
protect their children.
‘‘It’s a big responsibility,
and there’s a real passion for
people who want to help
children,’’ Herrmann said. ‘‘We
would just like to be able to let
more people know about child
passenger safety as a potential
to fit in with their current job
responsibilities to protect and
advocate for children.’’
STATISTIC
Safe Kids Worldwide reports that child safety seats can reduce fatal injury by up to 71 percent for infants and 54 percent for toddlers. In 2011, restraint use saved 263 lives, according to the organization.
STATISTIC
Motor vehicle crashes are the No. 1 cause of death for people ages 1 to 19 years, according to Safe Kids Worldwide.
14
WASHINGTON WATCH | Ken Steinhardt, ENA Director of Government Relations
‘Medical harm is a major cause of
suffering, disability and death
— as well as a huge financial cost to
our nation,’’ Sen. Bernie Sanders
(I-Vt.) said at the outset of the July 17 hearing of the Senate
Subcommittee on Primary Health and Aging. At this
subcommittee hearing, hospital quality and patient safety
experts urged lawmakers to establish measures to minimize
the number of medical errors in hospitals. According to one
of the witnesses at the hearing, more than 220,000 deaths
occur each year because of preventable medical mistakes.
Another witness cited the figure of 440,000 preventable
deaths due to errors committed by the health care system.
In addition to deaths and injuries, medical errors also cost
the United States billions of dollars. The health policy journal
Health Affairs published a study that put the figure at
$17 billion a year. Counting indirect costs such as lost
productivity due to missed work days, medical errors cost
nearly $1 trillion each year, according to a 2012 report in the
Journal of Health Care Finance.
One of the witnesses at the congressional hearing was
Joanne Disch, PhD, RN, FAAN, clinical professor at the
University of Minnesota School of Nursing. Disch testified
there are many factors that lead to medical errors, including
the ‘‘complexity of health care, the rapid generation of new
knowledge and interventions, the patchwork nature of our
health care system, the incentives to do too many
interventions and not enough assessment and prevention,
and the use of new technology (both too much and little).’’
Disch also highlighted several recommendations based on
her 46 years of experience as a nurse that she believes will
lead to a measurable improvement in patient safety. These
include (1) ensuring a sufficient supply of highly educated
nurses, (2) actively engaging patients and families as
partners in their care and (3) convincing hospitals and other
healthcare settings to embrace a culture of safety.
Another witness, Dr. Peter Pronovost, director of the
Armstrong Institute for Patient Safety and Quality at Johns
Hopkins University, testified that though progress has been
made, thousands of patients are still dying unnecessarily
from infections, preventable blood clots, adverse drug
events, falls, overexposure to medical radiation and
diagnostic errors.
‘‘We need to declare right now that preventable harm is
unacceptable and work to prevent all types of harm,’’
Pronovost said.
Ashish Jha, MD, MPH, a Harvard School of Public Health
professor, testified that American hospital patients are no
safer today than they were in 1999, when the Institute of
Medicine released its report ‘‘To Err is Human.’’
‘‘We have not moved the needle in any demonstrable way
overall,’’ he said. ‘‘No one is getting it right consistently.’’
In addition to the recommendations set forth by Disch,
witnesses offered a wide array of initiatives for reducing
medical errors, such as expanding the role of the Centers for
Disease Control and Prevention to compile and report
patient safety data, establishing a national patient safety
board or increasing the oversight responsibilities of Centers
for Medicare and Medicaid Services and the Joint
Commission. Witnesses also called on providers to improve
information technology systems and create incentives to
enhance safety throughout the entire health care system.
The hearing by the Primary Health and Aging
Subcommittee wasn’t the only activity in Washington
focused on patient safety. In April, Sen. Barbara Boxer
(D-Calif.) released a new report detailing the most common
and harmful errors at our nation’s hospitals and what
hospitals in California are doing to prevent them.
Boxer wrote to 283 California acute-care hospitals asking
them to respond with the actions they are taking to improve
patient safety. As of July, 87 percent of the hospitals had
responded. Notably, the survey found that all the hospitals
are taking at least some steps to address the most common
medical errors, while others were pursuing unique
approaches to enhance patient safety.
For example, UCLA Medical Center reported that it
disinfects hospital rooms using ultraviolet technology,
prohibits the use of home-laundered scrubs and bans
healthcare professionals with open wounds, bandages or
casts from scrubbing into surgeries. Desert Valley Hospital in
Victorville reported that it reduced the number of surgical
site infections from 16 in 2009 to 2 in 2013 after starting an
innovative program that rewards medical staff who are
observed practicing good hand hygiene.
The hearing held by the Senate Subcommittee on
Primary Health and Aging and the important
report produced by Boxer’s office show an
increased focus by our federal
representatives on the issue of
medical errors and patient safety.
Given the opportunity to save
countless lives, it is our
hope that this work will
lead to meaningful
legislation.
Medical Errors on Senate’s Radar When vascular access presents a challenge
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References: 1. Rogers JJ, Fox M, Miller LJ, Philbeck TE. Safety of intraosseous vascular access in the 21st century [WoCoVA abstract O-079]. J Vasc Access. 2012;13(2): 1A-40A. 2. Paxton JH, Knuth TE, Klausner HA. Proximal humerus intraosseous infusion: a preferred emergency venous access. J Trauma. 2009;67(3):1-7. 3. Cooper BR, Mahoney PF, Hodgetts TJ, Mellor A. Intra-osseous access (Ez-IO®) for resuscitation: UK military combat experience. J R Army Med Corps. 2007; 153(4):314-316. 4. Dolister M, Miller S, Borron S, et al. Intraosseous vascular access is safe, effective and costs less than central venous catheters for patients in the hospital setting [published online ahead of print January 3, 2013]. J Vasc Access. doi:10.5301/jva.5000130.
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Potential complications may include local or systemic infection, hematoma, extravasations or other complications associated with percutaneous insertion of steri le devices.
References: 1. Rogers JJ, Fox M, Miller LJ, Philbeck TE. Safety of intraosseous vascular access in the 21st century [WoCoVA abstract O-079]. J Vasc Access. 2012;13(2): 1A-40A. 2. Paxton JH, Knuth TE, Klausner HA. Proximal humerus intraosseous infusion: a preferred emergency venous access. J Trauma. 2009;67(3):1-7. 3. Cooper BR, Mahoney PF, Hodgetts TJ, Mellor A. Intra-osseous access (Ez-IO®) for resuscitation: UK military combat experience. J R Army Med Corps. 2007; 153(4):314-316. 4. Dolister M, Miller S, Borron S, et al. Intraosseous vascular access is safe, effective and costs less than central venous catheters for patients in the hospital setting [published online ahead of print January 3, 2013]. J Vasc Access. doi:10.5301/jva.5000130.
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October 201416
BEHAVIORAL HEALTH
T he U.S. Substance Abuse and Mental Health Services
Administration (SAMHSA) and the Mental Health
Association of New York City (MHA of NYC) launched the
National Suicide Prevention Lifeline in 2005 to provide
confidential, free support to those in a suicidal crisis via a
network of 24/7 crisis intervention centers. Through the
National Suicide Prevention Lifeline Crisis Center Follow-Up
grant program, funded by SAMHSA, a subdivision of crisis-
center grantees also provides follow-up services and continuity
of care for patients discharged from emergency departments.
With the patient’s consent, these centers contact the patients to
help them receive the appropriate behavioral health services.
One of these centers, the Acute Care Services lifeline crisis
center in West Bend, Wis., is partnered with Froedtert & the
Medical College of Wisconsin St. Joseph’s Hospital and
handles 1,000 to 1,200 contacts per month, consisting of
walk-ins, mobile crisis interventions, calls coming into the
center and follow-ups. Lori Landy, the behavioral health care
coordinator at St. Joseph’s Hospital, says partnering with a
24/7 mobile crisis team that responds to the ED has been an
invaluable resource.
‘‘It’s been five years [that we’ve] worked cooperatively
trying to meet the needs of patients with behavioral health
issues or concerns in the ER while focusing on the least
restrictive interventions whenever possible,’’ Landy said. ‘‘In
return, they [ACS] connect the patient to the lifeline and
follow up with them.’’
Although St. Joseph’s does not have a behavioral health
unit onsite, Landy says her position allows her to complete
consultations in the ED and assess suicidal patients.
‘‘St. Joseph’s recognizes that just because we don’t have a
behavioral health unit, it doesn’t mean that we are not going
to have a behavioral health crisis in the ED. We might have
them more frequently,’’ she said.
When an ED nurse recently called her about a suicidal
patient who had relapsed, she was able to assess the patient
instead, allowing the nurse to get back to bedside patient care.
‘‘St. Joseph’s recognizes the need for a specialized role in
the ER,’’ Landy said. ‘‘One of the nurses’ frustrations, often, in
our ER is that they spend more time on the phone calling for
services for patients with behavioral health needs and the
amount of time it takes to get a person referred to
appropriate services. That’s where I come in. It can take
hours to find beds and find treatments, and that’s not always
the best use of the ER nurse’s skill. I think the biggest benefit
for the ED nurses is having a crisis partnership like this that
gets them back to bedside where they are needed and away
from the role of trying to be a nurse case manager on the
phone. It’s out of their scope and takes them away from
patients and critical health issues.’’
St. Joseph’s staff nurse Ginger Knapp, RN, CEN, considers
Acute Care Services another part of her ED team.
‘‘ACS comes to the patient’s bedside and spends time
talking to our suicidal patients and then determines the best
plan for these patients,’’ Knapp said. ‘‘For some patients, ACS
can ‘safety plan to home.’ ACS coordinates the safety plan
based on the patient’s needs and also coordinates the
follow-up for this. A safety plan to home is a great option for
people. It saves money by preventing a hospitalization. It also
prevents the patient from having to appear before a judge, as
they would if they were chaptered. Also, these patients do not
need the added stress of missing work for a hospitalization.’’
After ACS interviews the patient, a determination may be
made on inpatient care, which can be voluntary or involuntary.
‘‘ACS can facilitate these transfers a lot faster than I can,’’
Knapp said. ‘‘A transfer requires a lot of sitting on the phone,
calling different mental health facilities to find openings. ACS
takes care of all of this. They provide the nurse with the name
of the hospital and the phone number to intake. Sometimes
you go through the intake process, only to find out the patient
is declined at a certain facility. We just let ACS know, and they
do the legwork and provide us with another facility.’’
The partnership with ACS gives patients an opportunity to
talk openly.
‘‘Patients really appreciate the ability to talk,’’ Knapp said.
‘‘The ER staff frequently does not have time to do this. These
patients are often accompanied by the police. For the most
part, when ACS does their interview with the patient, the
police step out of the room. ACS can really get to the root of
the problem. This can really diffuse a situation.’’
Patients who consult with ACS typically move through the
department faster, Knapp said.
‘‘This helps overall throughput,’’ she said. ‘‘If the
department keeps moving, all of our patients are happy.’’
By Kendra Y. Mims, ENA Connection
Lori Landy Ginger Knapp
A Friend to Call OnGrant Program for Suicide Crisis Lifelines Allows Wisconsin Center to Give Local ED a Helping Hand
Official Magazine of the Emergency Nurses Association 17
Save the DateApril 28-29, 2015
Plan to join ENA in Washington D.C. to advocate for issues that are
important to emergency nurses.
Details about the event and registration information will be available in January 2015.
Day on the Hill 2015 Ad_Connection_half_10 2014.indd 1 8/29/14 1:14 PM
ENA Trauma Committee Develops Tourniquet-Use TIPCongratulations to ENA’s Trauma Committee on the
development of a Translation Into Practice document
regarding the use of tourniquets. This evidence-based
document includes recommendations for the use of
tourniquets, along with
supporting rationale as it
relates to extremity trauma to
reduce blood loss, thus
decreasing morbidity and
mortality.
Committee members
include Ellie Encapera, RN, CEN, board liaison; Patricia Kunz
Howard, PhD, RN, CEN, CPEN, NE-BC, FAEN, FAAN,
chairperson; Pete Benolken, MSN, RN, EMT-B, CEN, CPEN;
Stacey Hill, BSN, RN; Kimberly Murphy, MSN, RN, CEN,
ACNP-BC, MICN, PHN; Maria Tackett, EdD, MSN, RN, CEN,
CCRN; Leslie Gates, senior administrative assistant; and Dale
Wallerich, MBA, BSN, RN, CEN, staff liaison.
This and other TIPs may be found at
tinyurl.com/ENA-TIPS or by scanning the
QR code here.
Chamberlain College of Nursing | National Management Offi ces3005 Highland Parkway | Downers Grove, IL 60515 | 888.556.8CCN (8226) | chamberlain.edu
Comprehensive program-specifi c consumer information: chamberlain.edu/studentconsumerinfo. Program/program option availability varies by state/location. The Bachelor of Science in Nursing degree program and the Master of Science in Nursing degree program are accredited by the Commission on Collegiate Nursing Education (CCNE, One Dupont Circle, NW, Suite 530, Washington, DC 20036, 202.887.6791). Chamberlain College of Nursing, 2450 Crystal Drive, Arlington, VA 22202 is certifi ed to operate by the State Council of Higher Education for Virginia, 101 N. 14th Street, 10th Floor, James Monroe Building, Richmond, VA 23219, 804.225.2600. Chamberlain College of Nursing has provisional approval from the Virginia Board of Nursing, Perimeter Center, 9960 Mayland Drive, Suite 300, Henrico, VA 23233-1463, 804.367.4515. ©2013 Chamberlain College of Nursing, LLC. All rights reserved.
Take advantage of your ENA membership benefi ts at Chamberlain College of Nursing.
• 15% savings of current tuition rate• Online coursework• No mandatory login times
Find your extraordinary at chamberlain.edu/enaorg
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visit ADASUVE.COM
ADASUVE® (loxapine) inhalation powder
HELP DEFUSE THE SITUATION BEFORE AGITATION ESCALATES FURTHER
Breath-actuated, single-use, ready-to-use inhaler1
ORAL INHALATION
FAST ONSET
Statistically signifi cant reduction in agitation at 2 hours, with improvement rapidly achieved at 10 minutes post-dose1
References: 1. ADASUVE [package insert]. Horsham, PA: Teva Select Brands, a division of Teva Pharmaceuticals USA, Inc; December 2013. 2. Data on fi le. Clinical Study Report 004-301. Teva Pharmaceuticals. 3. Data on fi le. Clinical Study Report 004-302. Teva Pharmaceuticals.
Orally inhaled medicine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
The mean baseline PEC scores in all treatment groups were 17.3 to 17.7.
BIPOLAR I DISORDERSCHIZOPHRENIAENDPOINT
AT 2 HOURS(PRIMARY)
AT 10 MINUTES (SECONDARY)
Reduction from baseline in agitation symptoms2,3
PEC=Positive and Negative Syndrome Scale-Excited Component. Intent-to-treat population with last observation carried forward. Agitation symptoms measured: tension, excitement, poor impulse control, uncooperativeness, hostility. Each item is scored on a scale from 1 to 7 (1=absent, 4=moderate, 7=extreme). Patient total PEC scores ranged from 14 to 31 out of a possible 35.The efficacy of ADASUVE 10 mg in the acute treatment of agitation associated with schizophrenia or bipolar I disorder was established in a short-term (24-hour), randomized, double-blind, placebo-controlled, fixed-dose trial including 344 patients who met DSM-IV criteria for schizophrenia and in another study, 314 patients who met DSM-IV criteria for bipolar I disorder, manic or mixed episodes with or without psychotic features.
ADASUVE ADASUVEPLACEBO PLACEBO
33%49%
10%19%
27%53%
10%23%
10min
S:9.5”
T:14”
T:10”
B:17”
B:12”
S:13.5”
THE FIRST AND ONLY…
©2014 Teva Pharmaceuticals USA, Inc. All rights reserved. April 2014 Printed in USA. ADA-40010
When agitation escalates…
HOW LONG CAN YOU WAIT?
INDICATIONS AND USAGEADASUVE® (loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Ef� cacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.Limitations of Use: As part of the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION (continued)• After ADASUVE administration, patients must be monitored for signs and symptoms of bronchospasm at
least every 15 minutes for at least 1 hour• ADASUVE can cause sedation, which can mask the symptoms of bronchospasm• Antipsychotic drugs can cause a potentially fatal symptom complex called Neuroleptic Malignant
Syndrome (NMS), manifested by hyperpyrexia, muscle rigidity, altered mental state, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Associated features can include escalated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure. If NMS occurs, immediately discontinue antipsychotic drugs and other drugs that may contribute to the underlying disorder, monitor and treat symptoms, and treat any concomitant serious medical problems
• ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that would predispose patients to hypotension. In the presence of severe hypotension requiring vasopressor therapy, epinephrine should not be used
• Use ADASUVE with caution in patients with a history of seizures or with conditions that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine and can also occur in epileptic patients
• Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking, and motor skills• The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants• Treatment with antipsychotic drugs caused an increased incidence of stroke and transient ischemic
attack in elderly patients with dementia-related psychosis; ADASUVE is not approved for the treatment of patients with dementia-related psychosis
• Use of ADASUVE may exacerbate glaucoma or cause urinary retention• The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical studies in
patients with agitation treated with ADASUVE were dysgeusia, sedation, and throat irritation• Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy
are at risk of extrapyramidal and/or withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only if the potential bene� t justi� es the potential risk to the fetus
• Nursing mothers: Discontinue drug or nursing, taking into account the importance of the drug to the mother• The safety and effectiveness of ADASUVE in pediatric patients have not been established
• ADASUVE is contraindicated in patients with the following:— Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung
disease associated with bronchospasm— Acute respiratory signs/symptoms (eg, wheezing)— Current use of medications to treat airways disease, such as asthma or COPD— History of bronchospasm following ADASUVE treatment— Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral
loxapine and amoxapine• ADASUVE must be administered only by a healthcare professional• Prior to administration, all patients must be screened for a history of pulmonary disease and examined
(including chest auscultation) for respiratory abnormalities (eg, wheezing)• Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation using the
single-use inhaler
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM andINCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
BronchospasmADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.Increased Mortality in Elderly Patients With Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
ADASUVE® (loxapine) inhalation powder 10 mg
Please see Brief Summary of Prescribing Information, including Boxed Warnings, on following pages.
For REMS Program information, visit
ADASUVEREMS.COM or call 855-755-0492
For more information about ADASUVE,
visit ADASUVE.COM
ADASUVE® (loxapine) inhalation powder
HELP DEFUSE THE SITUATION BEFORE AGITATION ESCALATES FURTHER
Breath-actuated, single-use, ready-to-use inhaler1
ORAL INHALATION
FAST ONSET
Statistically signifi cant reduction in agitation at 2 hours, with improvement rapidly achieved at 10 minutes post-dose1
References: 1. ADASUVE [package insert]. Horsham, PA: Teva Select Brands, a division of Teva Pharmaceuticals USA, Inc; December 2013. 2. Data on fi le. Clinical Study Report 004-301. Teva Pharmaceuticals. 3. Data on fi le. Clinical Study Report 004-302. Teva Pharmaceuticals.
Orally inhaled medicine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
The mean baseline PEC scores in all treatment groups were 17.3 to 17.7.
BIPOLAR I DISORDERSCHIZOPHRENIAENDPOINT
AT 2 HOURS(PRIMARY)
AT 10 MINUTES (SECONDARY)
Reduction from baseline in agitation symptoms2,3
PEC=Positive and Negative Syndrome Scale-Excited Component. Intent-to-treat population with last observation carried forward. Agitation symptoms measured: tension, excitement, poor impulse control, uncooperativeness, hostility. Each item is scored on a scale from 1 to 7 (1=absent, 4=moderate, 7=extreme). Patient total PEC scores ranged from 14 to 31 out of a possible 35.The efficacy of ADASUVE 10 mg in the acute treatment of agitation associated with schizophrenia or bipolar I disorder was established in a short-term (24-hour), randomized, double-blind, placebo-controlled, fixed-dose trial including 344 patients who met DSM-IV criteria for schizophrenia and in another study, 314 patients who met DSM-IV criteria for bipolar I disorder, manic or mixed episodes with or without psychotic features.
ADASUVE ADASUVEPLACEBO PLACEBO
33%49%
10%19%
27%53%
10%23%
10min
S:9.5”
T:14”
T:10”
B:17”
B:12”
S:13.5”
THE FIRST AND ONLY…
©2014 Teva Pharmaceuticals USA, Inc. All rights reserved. April 2014 Printed in USA. ADA-40010
When agitation escalates…
HOW LONG CAN YOU WAIT?
INDICATIONS AND USAGEADASUVE® (loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Ef� cacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.Limitations of Use: As part of the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION (continued)• After ADASUVE administration, patients must be monitored for signs and symptoms of bronchospasm at
least every 15 minutes for at least 1 hour• ADASUVE can cause sedation, which can mask the symptoms of bronchospasm• Antipsychotic drugs can cause a potentially fatal symptom complex called Neuroleptic Malignant
Syndrome (NMS), manifested by hyperpyrexia, muscle rigidity, altered mental state, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Associated features can include escalated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure. If NMS occurs, immediately discontinue antipsychotic drugs and other drugs that may contribute to the underlying disorder, monitor and treat symptoms, and treat any concomitant serious medical problems
• ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that would predispose patients to hypotension. In the presence of severe hypotension requiring vasopressor therapy, epinephrine should not be used
• Use ADASUVE with caution in patients with a history of seizures or with conditions that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine and can also occur in epileptic patients
• Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking, and motor skills• The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants• Treatment with antipsychotic drugs caused an increased incidence of stroke and transient ischemic
attack in elderly patients with dementia-related psychosis; ADASUVE is not approved for the treatment of patients with dementia-related psychosis
• Use of ADASUVE may exacerbate glaucoma or cause urinary retention• The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical studies in
patients with agitation treated with ADASUVE were dysgeusia, sedation, and throat irritation• Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy
are at risk of extrapyramidal and/or withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only if the potential bene� t justi� es the potential risk to the fetus
• Nursing mothers: Discontinue drug or nursing, taking into account the importance of the drug to the mother• The safety and effectiveness of ADASUVE in pediatric patients have not been established
• ADASUVE is contraindicated in patients with the following:— Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung
disease associated with bronchospasm— Acute respiratory signs/symptoms (eg, wheezing)— Current use of medications to treat airways disease, such as asthma or COPD— History of bronchospasm following ADASUVE treatment— Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral
loxapine and amoxapine• ADASUVE must be administered only by a healthcare professional• Prior to administration, all patients must be screened for a history of pulmonary disease and examined
(including chest auscultation) for respiratory abnormalities (eg, wheezing)• Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation using the
single-use inhaler
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM andINCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
BronchospasmADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.Increased Mortality in Elderly Patients With Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
ADASUVE® (loxapine) inhalation powder 10 mg
Please see Brief Summary of Prescribing Information, including Boxed Warnings, on following pages.
For REMS Program information, visit
ADASUVEREMS.COM or call 855-755-0492
For more information about ADASUVE,
visit ADASUVE.COM
ADASUVE® (loxapine) inhalation powder
HELP DEFUSE THE SITUATION BEFORE AGITATION ESCALATES FURTHER
Breath-actuated, single-use, ready-to-use inhaler1
ORAL INHALATION
FAST ONSET
Statistically signifi cant reduction in agitation at 2 hours, with improvement rapidly achieved at 10 minutes post-dose1
References: 1. ADASUVE [package insert]. Horsham, PA: Teva Select Brands, a division of Teva Pharmaceuticals USA, Inc; December 2013. 2. Data on fi le. Clinical Study Report 004-301. Teva Pharmaceuticals. 3. Data on fi le. Clinical Study Report 004-302. Teva Pharmaceuticals.
Orally inhaled medicine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
The mean baseline PEC scores in all treatment groups were 17.3 to 17.7.
BIPOLAR I DISORDERSCHIZOPHRENIAENDPOINT
AT 2 HOURS(PRIMARY)
AT 10 MINUTES (SECONDARY)
Reduction from baseline in agitation symptoms2,3
PEC=Positive and Negative Syndrome Scale-Excited Component. Intent-to-treat population with last observation carried forward. Agitation symptoms measured: tension, excitement, poor impulse control, uncooperativeness, hostility. Each item is scored on a scale from 1 to 7 (1=absent, 4=moderate, 7=extreme). Patient total PEC scores ranged from 14 to 31 out of a possible 35.The efficacy of ADASUVE 10 mg in the acute treatment of agitation associated with schizophrenia or bipolar I disorder was established in a short-term (24-hour), randomized, double-blind, placebo-controlled, fixed-dose trial including 344 patients who met DSM-IV criteria for schizophrenia and in another study, 314 patients who met DSM-IV criteria for bipolar I disorder, manic or mixed episodes with or without psychotic features.
ADASUVE ADASUVEPLACEBO PLACEBO
33%49%
10%19%
27%53%
10%23%
10min
S:9.5”
T:14”
T:10”
B:17”
B:12”
S:13.5”
THE FIRST AND ONLY…
©2014 Teva Pharmaceuticals USA, Inc. All rights reserved. April 2014 Printed in USA. ADA-40010
When agitation escalates…
HOW LONG CAN YOU WAIT?
INDICATIONS AND USAGEADASUVE® (loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Ef� cacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.Limitations of Use: As part of the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION (continued)• After ADASUVE administration, patients must be monitored for signs and symptoms of bronchospasm at
least every 15 minutes for at least 1 hour• ADASUVE can cause sedation, which can mask the symptoms of bronchospasm• Antipsychotic drugs can cause a potentially fatal symptom complex called Neuroleptic Malignant
Syndrome (NMS), manifested by hyperpyrexia, muscle rigidity, altered mental state, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Associated features can include escalated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure. If NMS occurs, immediately discontinue antipsychotic drugs and other drugs that may contribute to the underlying disorder, monitor and treat symptoms, and treat any concomitant serious medical problems
• ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that would predispose patients to hypotension. In the presence of severe hypotension requiring vasopressor therapy, epinephrine should not be used
• Use ADASUVE with caution in patients with a history of seizures or with conditions that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine and can also occur in epileptic patients
• Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking, and motor skills• The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants• Treatment with antipsychotic drugs caused an increased incidence of stroke and transient ischemic
attack in elderly patients with dementia-related psychosis; ADASUVE is not approved for the treatment of patients with dementia-related psychosis
• Use of ADASUVE may exacerbate glaucoma or cause urinary retention• The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical studies in
patients with agitation treated with ADASUVE were dysgeusia, sedation, and throat irritation• Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy
are at risk of extrapyramidal and/or withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only if the potential bene� t justi� es the potential risk to the fetus
• Nursing mothers: Discontinue drug or nursing, taking into account the importance of the drug to the mother• The safety and effectiveness of ADASUVE in pediatric patients have not been established
• ADASUVE is contraindicated in patients with the following:— Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung
disease associated with bronchospasm— Acute respiratory signs/symptoms (eg, wheezing)— Current use of medications to treat airways disease, such as asthma or COPD— History of bronchospasm following ADASUVE treatment— Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral
loxapine and amoxapine• ADASUVE must be administered only by a healthcare professional• Prior to administration, all patients must be screened for a history of pulmonary disease and examined
(including chest auscultation) for respiratory abnormalities (eg, wheezing)• Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation using the
single-use inhaler
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM andINCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
BronchospasmADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.Increased Mortality in Elderly Patients With Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
ADASUVE® (loxapine) inhalation powder 10 mg
Please see Brief Summary of Prescribing Information, including Boxed Warnings, on following pages.
For REMS Program information, visit
ADASUVEREMS.COM or call 855-755-0492
For more information about ADASUVE,
visit ADASUVE.COM
ADASUVE® (loxapine) inhalation powder
HELP DEFUSE THE SITUATION BEFORE AGITATION ESCALATES FURTHER
Breath-actuated, single-use, ready-to-use inhaler1
ORAL INHALATION
FAST ONSET
Statistically signifi cant reduction in agitation at 2 hours, with improvement rapidly achieved at 10 minutes post-dose1
References: 1. ADASUVE [package insert]. Horsham, PA: Teva Select Brands, a division of Teva Pharmaceuticals USA, Inc; December 2013. 2. Data on fi le. Clinical Study Report 004-301. Teva Pharmaceuticals. 3. Data on fi le. Clinical Study Report 004-302. Teva Pharmaceuticals.
Orally inhaled medicine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
The mean baseline PEC scores in all treatment groups were 17.3 to 17.7.
BIPOLAR I DISORDERSCHIZOPHRENIAENDPOINT
AT 2 HOURS(PRIMARY)
AT 10 MINUTES (SECONDARY)
Reduction from baseline in agitation symptoms2,3
PEC=Positive and Negative Syndrome Scale-Excited Component. Intent-to-treat population with last observation carried forward. Agitation symptoms measured: tension, excitement, poor impulse control, uncooperativeness, hostility. Each item is scored on a scale from 1 to 7 (1=absent, 4=moderate, 7=extreme). Patient total PEC scores ranged from 14 to 31 out of a possible 35.The efficacy of ADASUVE 10 mg in the acute treatment of agitation associated with schizophrenia or bipolar I disorder was established in a short-term (24-hour), randomized, double-blind, placebo-controlled, fixed-dose trial including 344 patients who met DSM-IV criteria for schizophrenia and in another study, 314 patients who met DSM-IV criteria for bipolar I disorder, manic or mixed episodes with or without psychotic features.
ADASUVE ADASUVEPLACEBO PLACEBO
33%49%
10%19%
27%53%
10%23%
10min
S:9.5”
T:14”
T:10”
B:17”
B:12”
S:13.5”
THE FIRST AND ONLY…
©2014 Teva Pharmaceuticals USA, Inc. All rights reserved. April 2014 Printed in USA. ADA-40010
When agitation escalates…
HOW LONG CAN YOU WAIT?
INDICATIONS AND USAGEADASUVE® (loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Ef� cacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.Limitations of Use: As part of the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION (continued)• After ADASUVE administration, patients must be monitored for signs and symptoms of bronchospasm at
least every 15 minutes for at least 1 hour• ADASUVE can cause sedation, which can mask the symptoms of bronchospasm• Antipsychotic drugs can cause a potentially fatal symptom complex called Neuroleptic Malignant
Syndrome (NMS), manifested by hyperpyrexia, muscle rigidity, altered mental state, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Associated features can include escalated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure. If NMS occurs, immediately discontinue antipsychotic drugs and other drugs that may contribute to the underlying disorder, monitor and treat symptoms, and treat any concomitant serious medical problems
• ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that would predispose patients to hypotension. In the presence of severe hypotension requiring vasopressor therapy, epinephrine should not be used
• Use ADASUVE with caution in patients with a history of seizures or with conditions that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine and can also occur in epileptic patients
• Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking, and motor skills• The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants• Treatment with antipsychotic drugs caused an increased incidence of stroke and transient ischemic
attack in elderly patients with dementia-related psychosis; ADASUVE is not approved for the treatment of patients with dementia-related psychosis
• Use of ADASUVE may exacerbate glaucoma or cause urinary retention• The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical studies in
patients with agitation treated with ADASUVE were dysgeusia, sedation, and throat irritation• Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy
are at risk of extrapyramidal and/or withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only if the potential bene� t justi� es the potential risk to the fetus
• Nursing mothers: Discontinue drug or nursing, taking into account the importance of the drug to the mother• The safety and effectiveness of ADASUVE in pediatric patients have not been established
• ADASUVE is contraindicated in patients with the following:— Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung
disease associated with bronchospasm— Acute respiratory signs/symptoms (eg, wheezing)— Current use of medications to treat airways disease, such as asthma or COPD— History of bronchospasm following ADASUVE treatment— Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral
loxapine and amoxapine• ADASUVE must be administered only by a healthcare professional• Prior to administration, all patients must be screened for a history of pulmonary disease and examined
(including chest auscultation) for respiratory abnormalities (eg, wheezing)• Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation using the
single-use inhaler
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM andINCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
BronchospasmADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.Increased Mortality in Elderly Patients With Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
ADASUVE® (loxapine) inhalation powder 10 mg
Please see Brief Summary of Prescribing Information, including Boxed Warnings, on following pages.
For REMS Program information, visit
ADASUVEREMS.COM or call 855-755-0492
For more information about ADASUVE,
visit ADASUVE.COM
ADASUVE® (loxapine) inhalation powder
HELP DEFUSE THE SITUATION BEFORE AGITATION ESCALATES FURTHER
Breath-actuated, single-use, ready-to-use inhaler1
ORAL INHALATION
FAST ONSET
Statistically signifi cant reduction in agitation at 2 hours, with improvement rapidly achieved at 10 minutes post-dose1
References: 1. ADASUVE [package insert]. Horsham, PA: Teva Select Brands, a division of Teva Pharmaceuticals USA, Inc; December 2013. 2. Data on fi le. Clinical Study Report 004-301. Teva Pharmaceuticals. 3. Data on fi le. Clinical Study Report 004-302. Teva Pharmaceuticals.
Orally inhaled medicine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
The mean baseline PEC scores in all treatment groups were 17.3 to 17.7.
BIPOLAR I DISORDERSCHIZOPHRENIAENDPOINT
AT 2 HOURS(PRIMARY)
AT 10 MINUTES (SECONDARY)
Reduction from baseline in agitation symptoms2,3
PEC=Positive and Negative Syndrome Scale-Excited Component. Intent-to-treat population with last observation carried forward. Agitation symptoms measured: tension, excitement, poor impulse control, uncooperativeness, hostility. Each item is scored on a scale from 1 to 7 (1=absent, 4=moderate, 7=extreme). Patient total PEC scores ranged from 14 to 31 out of a possible 35.The efficacy of ADASUVE 10 mg in the acute treatment of agitation associated with schizophrenia or bipolar I disorder was established in a short-term (24-hour), randomized, double-blind, placebo-controlled, fixed-dose trial including 344 patients who met DSM-IV criteria for schizophrenia and in another study, 314 patients who met DSM-IV criteria for bipolar I disorder, manic or mixed episodes with or without psychotic features.
ADASUVE ADASUVEPLACEBO PLACEBO
33%49%
10%19%
27%53%
10%23%
10min
S:9.5”
T:14”
T:10”
B:17”
B:12”
S:13.5”
THE FIRST AND ONLY…
©2014 Teva Pharmaceuticals USA, Inc. All rights reserved. April 2014 Printed in USA. ADA-40010
When agitation escalates…
HOW LONG CAN YOU WAIT?
INDICATIONS AND USAGEADASUVE® (loxapine) inhalation powder, for oral inhalation use, is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Ef� cacy was demonstrated in 2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.Limitations of Use: As part of the ADASUVE Risk Evaluation and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility.
IMPORTANT SAFETY INFORMATION (continued)• After ADASUVE administration, patients must be monitored for signs and symptoms of bronchospasm at
least every 15 minutes for at least 1 hour• ADASUVE can cause sedation, which can mask the symptoms of bronchospasm• Antipsychotic drugs can cause a potentially fatal symptom complex called Neuroleptic Malignant
Syndrome (NMS), manifested by hyperpyrexia, muscle rigidity, altered mental state, irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia. Associated features can include escalated serum creatine phosphokinase (CPK) concentration, rhabdomyolysis, elevated serum and urine myoglobin concentration, and renal failure. If NMS occurs, immediately discontinue antipsychotic drugs and other drugs that may contribute to the underlying disorder, monitor and treat symptoms, and treat any concomitant serious medical problems
• ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions that would predispose patients to hypotension. In the presence of severe hypotension requiring vasopressor therapy, epinephrine should not be used
• Use ADASUVE with caution in patients with a history of seizures or with conditions that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine and can also occur in epileptic patients
• Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking, and motor skills• The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants• Treatment with antipsychotic drugs caused an increased incidence of stroke and transient ischemic
attack in elderly patients with dementia-related psychosis; ADASUVE is not approved for the treatment of patients with dementia-related psychosis
• Use of ADASUVE may exacerbate glaucoma or cause urinary retention• The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical studies in
patients with agitation treated with ADASUVE were dysgeusia, sedation, and throat irritation• Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy
are at risk of extrapyramidal and/or withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only if the potential bene� t justi� es the potential risk to the fetus
• Nursing mothers: Discontinue drug or nursing, taking into account the importance of the drug to the mother• The safety and effectiveness of ADASUVE in pediatric patients have not been established
• ADASUVE is contraindicated in patients with the following:— Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD), or other lung
disease associated with bronchospasm— Acute respiratory signs/symptoms (eg, wheezing)— Current use of medications to treat airways disease, such as asthma or COPD— History of bronchospasm following ADASUVE treatment— Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred with oral
loxapine and amoxapine• ADASUVE must be administered only by a healthcare professional• Prior to administration, all patients must be screened for a history of pulmonary disease and examined
(including chest auscultation) for respiratory abnormalities (eg, wheezing)• Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation using the
single-use inhaler
IMPORTANT SAFETY INFORMATION
WARNING: BRONCHOSPASM andINCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
BronchospasmADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.Increased Mortality in Elderly Patients With Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis.
ADASUVE® (loxapine) inhalation powder 10 mg
Please see Brief Summary of Prescribing Information, including Boxed Warnings, on following pages.
For REMS Program information, visit
ADASUVEREMS.COM or call 855-755-0492
For more information about ADASUVE,
visit ADASUVE.COM
ADASUVE® (loxapine) inhalation powder
HELP DEFUSE THE SITUATION BEFORE AGITATION ESCALATES FURTHER
Breath-actuated, single-use, ready-to-use inhaler1
ORAL INHALATION
FAST ONSET
Statistically signifi cant reduction in agitation at 2 hours, with improvement rapidly achieved at 10 minutes post-dose1
References: 1. ADASUVE [package insert]. Horsham, PA: Teva Select Brands, a division of Teva Pharmaceuticals USA, Inc; December 2013. 2. Data on fi le. Clinical Study Report 004-301. Teva Pharmaceuticals. 3. Data on fi le. Clinical Study Report 004-302. Teva Pharmaceuticals.
Orally inhaled medicine indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults
The mean baseline PEC scores in all treatment groups were 17.3 to 17.7.
BIPOLAR I DISORDERSCHIZOPHRENIAENDPOINT
AT 2 HOURS(PRIMARY)
AT 10 MINUTES (SECONDARY)
Reduction from baseline in agitation symptoms2,3
PEC=Positive and Negative Syndrome Scale-Excited Component. Intent-to-treat population with last observation carried forward. Agitation symptoms measured: tension, excitement, poor impulse control, uncooperativeness, hostility. Each item is scored on a scale from 1 to 7 (1=absent, 4=moderate, 7=extreme). Patient total PEC scores ranged from 14 to 31 out of a possible 35.The efficacy of ADASUVE 10 mg in the acute treatment of agitation associated with schizophrenia or bipolar I disorder was established in a short-term (24-hour), randomized, double-blind, placebo-controlled, fixed-dose trial including 344 patients who met DSM-IV criteria for schizophrenia and in another study, 314 patients who met DSM-IV criteria for bipolar I disorder, manic or mixed episodes with or without psychotic features.
ADASUVE ADASUVEPLACEBO PLACEBO
33%49%
10%19%
27%53%
10%23%
10min
S:9.5”T:14”
T:10”B:17”
B:12”
S:13.5”
BRIEF SUMMARYADASUVE® (loxapine) inhalation powder, for oral inhalation use The following is a brief summary only; see full prescribing informa-tion, included Boxed Warnings for complete product information.
WARNING: BRONCHOSPASM and INCREASED MORTALITYIN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Bronchospasm ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bron-chospasm, including advanced airway management (intubation and mechanical ventilation) [see Warnings and Precautions (5.1, 5.2)]. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE [see Dosage and Administration (2.2, 2.4) and Contraindications (4)].Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS [see Warnings and Pre-cautions (5.2)]. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with anti-psychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psycho-sis [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGEADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.“Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behav-ior), leading clinicians to the use of rapidly absorbed antipsychotic medica-tions to achieve immediate control of the agitation [see Clinical Studies (14)].The efficacy of ADASUVE was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar I disorder [see Clinical Studies (14)]. Limitations of Use:As part of the ADASUVE REMS Program to mitigate the risk of broncho-spasm, ADASUVE must be administered only in an enrolled healthcare facility [see Warnings and Precautions (5.2)].4 CONTRAINDICATIONSADASUVE is contraindicated in patients with the following:• Current diagnosis or history of asthma, COPD, or other lung disease
associated with bronchospasm [see Warnings and Precautions (5.1)]• Acute respiratory symptomsor signs (e.g., wheezing) [see Warnings
and Precautions (5.1)]• Currentuseofmedicationstotreatairwaysdisease,suchasasthmaorCOPD[see Warnings and Precautions (5.1)]
• HistoryofbronchospasmfollowingADASUVEtreatment[see Warnings and Precautions (5.1)]
• Knownhypersensitivityto loxapineoramoxapine.Seriousskinreac-tions have occurred with oral loxapine and amoxapine.
5 WARNINGS AND PRECAUTIONS5.1 BronchospasmADASUVE can cause bronchospasm that has the potential to lead to respi-ratory distress and respiratory arrest [see Adverse Reactions (6.1)]. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intuba-tion and mechanical ventilation) [see Boxed Warning and Warnings and Precautions (5.2)].Prior to administering ADASUVE, screen patients regarding a current diagnosisorhistoryofasthma,COPD,andotherlungdiseaseassociatedwith bronchospasm, acute respiratory symptoms or signs, current use of medicationstotreatairwaysdisease,suchasasthmaorCOPD;andexam-ine patients (including chest auscultation) for respiratory abnormalities (e.g., wheezing) [See Dosage and Administration (2.2) and Contraindi-cations (4)]. Monitor patients for symptoms and signs of bronchospasm (i.e., vital signs and chest auscultation) at least every 15 minutes for a minimum of one hour following treatment with ADASUVE [see Dosage and Administration (2.4)]. ADASUVE can cause sedation, which can mask the symptoms of bronchospasm.
BecauseclinicaltrialsinpatientswithasthmaorCOPDdemonstratedthatthe degree of bronchospasm, as indicated by changes in forced expira-tory volume in 1 second (FEV1), was greater following a second dose of ADASUVE, limit ADASUVE use to a single dose within a 24 hour period. Advise all patients of the risk of bronchospasm. Advise them to inform the healthcare professional if they develop any breathing problems such as wheezing, shortness of breath, chest tightness, or cough following treatment with ADASUVE.5.2 ADASUVE REMS to Mitigate Bronchospasm Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a REMS called the ADASUVE REMS. [see Boxed Warning and Warnings and Precautions (5.1)] Required compo-nents of the ADASUVE REMS are:• Healthcarefacilities thatdispenseandadministerADASUVEmustbeenrolled and comply with the REMS requirements. Certified health-care facilities must have on-site access to equipment and personnel trained to provide advance airway management, including intubation and mechanical ventilation.
• WholesalersanddistributorsthatdistributeADASUVEmustenroll inthe program and distribute only to enrolled healthcare facilities.
Further information is available at www.adasuverems.com or 1-855-755-0492.5.3 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsy-chotic drugs are at increased risk of death. Analyses of 17 placebo- controlled trials (modal duration of 10 weeks), largely in patients tak-ing atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of 1.6 to 1.7 times the risk of death in placebo-treated patients. Overthecourseofatypical10-weekcontrolledtrial,therateofdeathindrug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the cases of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sud-dendeath)orinfectious(e.g.,pneumonia)innature.Observationalstud-ies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies can be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ADASUVE is not approved for the treatment of elderly patients with dementia-related psychosis [see Boxed Warning].5.4 Neuroleptic Malignant Syndrome Antipsychotic drugs can cause a potentially fatal symptom complex termedNeurolepticMalignantSyndrome(NMS).Clinicalmanifestationsof NMS include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability (irregular pulse or blood pressure, tachycardia, dia-phoresis, and cardiac dysrhythmia). Associated features can include ele-vatedserumcreatinephosphokinase(CPK)concentration,rhabdomyoly-sis, elevated serum and urine myoglobin concentration, and renal failure. NMS did not occur in the ADASUVE clinical program.The diagnostic evaluation of patients with this syndrome is complicated. It is important to consider the presence of other serious medical con-ditions (e.g.,pneumonia,systemic infection,heatstroke,primaryCNSpathology, central anticholinergic toxicity, extrapyramidal symptoms, or drug fever). The management of NMS should include: 1) immediate discontinua-tion of antipsychotic drugs and other drugs that may contribute to the underlying disorder, 2) intensive symptomatic treatment and medical mon-itoring, and 3) treatment of any concomitant serious medical problems. There is no general agreement about specific pharmacological treatment regimens for NMS.If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported. 5.5 Hypotension and SyncopeADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use ADASUVE with caution in patients with known cardiovascular dis-ease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or condi-tions that would predispose patients to hypotension (dehydration, hypo-volemia, or treatment with antihypertensive medications or other drugs that affect blood pressure or reduce heart rate).In the presence of severe hypotension requiring vasopressor therapy, the preferred drugs may be norepinephrine or phenylephrine. Epinephrine should not be used, because beta stimulation may worsen hypotension in the setting of ADASUVE-induced partial alpha blockade.In short-term (24-hour) placebo-controlled trials of patients with agitation associated with schizophrenia or bipolar I disorder, hypotension occurred in 0.4% and 0.8% in the ADASUVE 10 mg and placebo groups, respec-tively. There were no cases of orthostatic hypotension, postural symptoms,
Table 1. Adverse Reactions in 3 Pooled Short-Term, Placebo-Controlled Trials (Studies 1, 2, and 3) in Patients with Schizophrenia or Bipolar Disorder
Adverse ReactionPlacebo(n = 263)
ADASUVE(n = 259)
Dysgeusia 5% 14%Sedation 10% 12%Throat Irritation 0% 3%
Airway Adverse Reactions in the 3 Trials in Acute Agitation Agitated patients with Schizophrenia or Bipolar Disorder: In the 3 short-term (24-hour), placebo-controlled trials in patients with agitation asso-ciated with schizophrenia or bipolar disorder (Studies 1, 2, and 3), bron-chospasm (which includes reports of wheezing, shortness of breath and cough) occurred more frequently in the ADASUVE group, compared to the placebo group: 0% (0/263) in the placebo group and 0.8% (2/259) intheADASUVE10mggroup.Onepatientwithschizophrenia,withouta history of pulmonary disease, had significant bronchospasm requiring rescue treatment with a bronchodilator and oxygen. Bronchospasm and Airway Adverse Reactions in Pulmonary Safety TrialsClinicalpulmonarysafetytrialsdemonstratedthatADASUVEcancausebronchospasm as measured by FEV1, and as indicated by respiratory signs and symptoms in the trials. In addition, the trials demonstrated thatpatientswithasthmaorotherpulmonarydiseases,suchasCOPDare at increased risk of bronchospasm. The effect of ADASUVE on pulmonary function was evaluated in 3 randomized, double-blind, placebo-controlled clinical pulmonary safety trials in healthy volunteers, patientswithasthma,andpatientswithCOPD.Pulmonaryfunctionwasassessed by serial FEV1 tests, and respiratory signs and symptoms were assessed.IntheasthmaandCOPDtrials,patientswithrespiratorysymp-toms or FEV1 decrease of ≥ 20% were administered rescue treatment with albuterol (metered dose inhaler or nebulizer) as required. These patientswerenoteligibleforaseconddose;however,theyhadcontinuedFEV1 monitoring in the trial. HealthyVolunteers: In the healthy volunteer crossover trial, 30 subjects received 2 doses of either ADASUVE or placebo 8 hours apart, and 2 doses of the alternate treatment at least 4 days later. The results for maximum decrease in FEV1 are presented in Table 2. No subjects in this trial devel-oped airway related adverse reactions (cough, wheezing, chest tightness, or dyspnea).Asthma Patients: In the asthma trial, 52 patients with mild-moderate persistent asthma (with FEV1 ≥ 60% of predicted) were randomized to treatment with 2 doses of ADASUVE 10 mg or placebo. The second dose was to be administered 10 hours after the first dose. Approximately 67% of these patients had a baseline FEV1 ≥ 80% of predicted. The remaining patients had an FEV1 60-80% of predicted. Nine patients (17%) were former smokers. As shown in Table 2 and Figure 7, there was a marked decrease in FEV1 immediately following the first dose (maximum mean decreases in FEV1 and % predicted FEV1 were 303 mL and 9.1%, respec-tively). Furthermore, the effect on FEV1 was greater following the second dose (maximum mean decreases in FEV1 and % predicted FEV1 were 537 mL and 14.7 %, respectively). Respiratory-related adverse reactions (bronchospasm, chest discomfort, cough, dyspnea, throat tightness, and wheezing) occurred in 54% of ADASUVE-treated patients and 12% of placebo-treated patients. There were no serious adverse events. Nine of 26 (35%) patients in the ADASUVE group, compared to one of 26 (4%) in the placebo group, did not receive a second dose of study medication, because they had a ≥ 20% decrease in FEV1 or they developed respiratory symptoms after the first dose. Rescue medication (albuterol via metered dose inhaler or nebulizer) was administered to 54% of patients in the ADASUVE group [7 patients (27%) after the first dose and 7 of the remain-ing 17 patients (41%) after the second dose] and 12% in the placebo group (1 patient after the first dose and 2 patients after the second dose).COPDPatients:IntheCOPDtrial,53patientswithmildtosevereCOPD(withFEV1 ≥ 40% of predicted) were randomized to treatment with 2 doses of ADASUVE 10 mg or placebo. The second dose was to be administered 10 hours after the first dose. Approximately 57% of these patients had moderateCOPD[Global Initiative forChronicObstructiveLungDisease(GOLD)StageII];32%hadseveredisease(GOLDStageIII);and11%hadmilddisease(GOLDStageI).AsillustratedinTable2therewasadecreasein FEV1 soon after the first dose (maximum mean decreases in FEV1 and % predicted FEV1 were 96 mL and 3.5%, respectively), and the effect on FEV1 was greater following the second dose (maximum mean decreases in FEV1 and % predicted FEV1 were 125 mL and 4.5%, respectively). Respi-ratory adverse reactions occurred more frequently in the ADASUVE group (19%) than in the placebo group (11%). There were no serious adverse events. Seven of 25 (28%) patients in the ADASUVE group and 1of 27 (4%) in the placebo group did not receive a second dose of study medication because of a ≥ 20% decrease in FEV1 or the development of respiratory symptoms after the first dose. Rescue medication (albuterol via MDI or
presyncope or syncope. A systolic blood pressure ≤90mmHgwithadecrease of ≥20mmHgoccurredin1.5%and0.8%oftheADASUVE10 mg and placebo groups, respectively. A diastolic blood pressure ≤50mmHgwithadecreaseof≥15mmHgoccurredin0.8%and0.4%of the ADASUVE 10 mg and placebo groups, respectively.In 5 Phase 1 studies in normal volunteers, the incidence of hypotension was 3% and 0% in ADASUVE 10 mg and the placebo groups, respec-tively. The incidence of syncope or presyncope in normal volunteers was 2.3% and 0% in the ADASUVE and placebo groups, respectively. In nor-mal volunteers, a systolic blood pressure ≤90mmHgwithadecreaseof ≥20mmHgoccurredin5.3%and1.1%intheADASUVEandplacebogroups, respectively. A diastolic blood pressure ≤ 50 mm Hg with adecrease of ≥15mmHgoccurredin7.5%and3.3%intheADASUVEandplacebo groups, respectively.5.6 SeizuresADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine. Seizures can occur in epileptic patients even during antiepileptic drug maintenance therapy. In short term (24 hour), placebo-controlled trials of ADASUVE, there were no reports of seizures. 5.7 Potential for Cognitive and Motor ImpairmentADASUVE can impair judgment, thinking, and motor skills. In short-term, placebo-controlled trials, sedation and/or somnolence were reported in 12% and 10% in the ADASUVE and placebo groups, respectively. No patients discontinued treatment because of sedation or somnolence.The potential for cognitive and motor impairment is increased when ADASUVEisadministeredconcurrentlywithotherCNSdepressants[see Drug Interactions (7.1)]. Caution patients about operating hazardousmachinery, including automobiles, until they are reasonably certain that therapy with ADASUVE does not affect them adversely. 5.8 Cerebrovascular Reactions, Including Stroke, in Elderly Patients with Dementia-Related PsychosisIn placebo-controlled trials with atypical antipsychotics in elderly patients with dementia-related psychosis, there was a higher incidence of cere-brovascular adverse reactions (stroke and transient ischemic attacks), including fatalities, compared to placebo-treated patients. ADASUVE is not approved for the treatment of patients with dementia-related psycho-sis [see Boxed Warning and Warnings and Precautions (5.3)].5.9 Anticholinergic Reactions Including Exacerbation of Glaucoma and Urinary RetentionADASUVE has anticholinergic activity, and it has the potential to cause anticholinergic adverse reactions including exacerbation of glaucoma or urinary retention. The concomitant use of other anticholinergic drugs (e.g., antiparkinson drugs) with ADASUVE could have additive effects. 6 ADVERSE REACTIONSThe following adverse reactions are discussed in more detail in other sections of the labeling:• Hypersensitivity(seriousskinreactions)[see Contraindications (4)] • Bronchospasm[see Warnings and Precautions (5.1)]• IncreasedMortalityinElderlyPatientswithDementia-RelatedPsycho-
sis [see Warnings and Precautions (5.3)]• NeurolepticMalignantSyndrome[see Warnings and Precautions (5.4)]• Hypotensionandsyncope[see Warnings and Precautions (5.5)]• Seizure[see Warnings and Precautions (5.6)]• Potential forCognitiveandMotorImpairment[see Warnings and Pre-
cautions (5.7)]• CerebrovascularReactions, IncludingStroke, inElderlyPatientswith
Dementia-Related Psychosis [see Warnings and Precautions (5.8)]• AnticholinergicReactionsIncludingExacerbationofGlaucomaandUri-
nary Retention [see Warnings and Precautions (5.9)]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.The following findings are based on pooled data from three short-term (24-hour), randomized, double-blind, placebo-controlled clinical trials (Studies 1, 2, and 3) of ADASUVE 10 mg in the treatment of patients with acute agitation associated with schizophrenia or bipolar I disorder. In the 3 trials, 259 patients received ADASUVE 10 mg, and 263 received placebo [see Clinical Studies (14)].Commonly Observed Adverse Reactions: In the 3 trials in acute agita-tion, the most common adverse reactions were dysgeusia, sedation, and throat irritation. These reactions occurred at a rate of at least 2% of the ADASUVE group and at a rate greater than in the placebo group. (Refer to Table 1).
S:13.5”
S:9.5”
T:14”
T:10”
B:17”
B:12”
BRIEF SUMMARYADASUVE® (loxapine) inhalation powder, for oral inhalation use The following is a brief summary only; see full prescribing informa-tion, included Boxed Warnings for complete product information.
WARNING: BRONCHOSPASM and INCREASED MORTALITYIN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Bronchospasm ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bron-chospasm, including advanced airway management (intubation and mechanical ventilation) [see Warnings and Precautions (5.1, 5.2)]. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE [see Dosage and Administration (2.2, 2.4) and Contraindications (4)].Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS [see Warnings and Pre-cautions (5.2)]. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with anti-psychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psycho-sis [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGEADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.“Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behav-ior), leading clinicians to the use of rapidly absorbed antipsychotic medica-tions to achieve immediate control of the agitation [see Clinical Studies (14)].The efficacy of ADASUVE was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar I disorder [see Clinical Studies (14)]. Limitations of Use:As part of the ADASUVE REMS Program to mitigate the risk of broncho-spasm, ADASUVE must be administered only in an enrolled healthcare facility [see Warnings and Precautions (5.2)].4 CONTRAINDICATIONSADASUVE is contraindicated in patients with the following:• Current diagnosis or history of asthma, COPD, or other lung disease
associated with bronchospasm [see Warnings and Precautions (5.1)]• Acute respiratory symptomsor signs (e.g., wheezing) [see Warnings
and Precautions (5.1)]• Currentuseofmedicationstotreatairwaysdisease,suchasasthmaorCOPD[see Warnings and Precautions (5.1)]
• HistoryofbronchospasmfollowingADASUVEtreatment[see Warnings and Precautions (5.1)]
• Knownhypersensitivityto loxapineoramoxapine.Seriousskinreac-tions have occurred with oral loxapine and amoxapine.
5 WARNINGS AND PRECAUTIONS5.1 BronchospasmADASUVE can cause bronchospasm that has the potential to lead to respi-ratory distress and respiratory arrest [see Adverse Reactions (6.1)]. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intuba-tion and mechanical ventilation) [see Boxed Warning and Warnings and Precautions (5.2)].Prior to administering ADASUVE, screen patients regarding a current diagnosisorhistoryofasthma,COPD,andotherlungdiseaseassociatedwith bronchospasm, acute respiratory symptoms or signs, current use of medicationstotreatairwaysdisease,suchasasthmaorCOPD;andexam-ine patients (including chest auscultation) for respiratory abnormalities (e.g., wheezing) [See Dosage and Administration (2.2) and Contraindi-cations (4)]. Monitor patients for symptoms and signs of bronchospasm (i.e., vital signs and chest auscultation) at least every 15 minutes for a minimum of one hour following treatment with ADASUVE [see Dosage and Administration (2.4)]. ADASUVE can cause sedation, which can mask the symptoms of bronchospasm.
BecauseclinicaltrialsinpatientswithasthmaorCOPDdemonstratedthatthe degree of bronchospasm, as indicated by changes in forced expira-tory volume in 1 second (FEV1), was greater following a second dose of ADASUVE, limit ADASUVE use to a single dose within a 24 hour period. Advise all patients of the risk of bronchospasm. Advise them to inform the healthcare professional if they develop any breathing problems such as wheezing, shortness of breath, chest tightness, or cough following treatment with ADASUVE.5.2 ADASUVE REMS to Mitigate Bronchospasm Because of the risk of bronchospasm, ADASUVE is available only through a restricted program under a REMS called the ADASUVE REMS. [see Boxed Warning and Warnings and Precautions (5.1)] Required compo-nents of the ADASUVE REMS are:• Healthcarefacilities thatdispenseandadministerADASUVEmustbeenrolled and comply with the REMS requirements. Certified health-care facilities must have on-site access to equipment and personnel trained to provide advance airway management, including intubation and mechanical ventilation.
• WholesalersanddistributorsthatdistributeADASUVEmustenroll inthe program and distribute only to enrolled healthcare facilities.
Further information is available at www.adasuverems.com or 1-855-755-0492.5.3 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsy-chotic drugs are at increased risk of death. Analyses of 17 placebo- controlled trials (modal duration of 10 weeks), largely in patients tak-ing atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of 1.6 to 1.7 times the risk of death in placebo-treated patients. Overthecourseofatypical10-weekcontrolledtrial,therateofdeathindrug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the cases of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sud-dendeath)orinfectious(e.g.,pneumonia)innature.Observationalstud-ies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies can be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ADASUVE is not approved for the treatment of elderly patients with dementia-related psychosis [see Boxed Warning].5.4 Neuroleptic Malignant Syndrome Antipsychotic drugs can cause a potentially fatal symptom complex termedNeurolepticMalignantSyndrome(NMS).Clinicalmanifestationsof NMS include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability (irregular pulse or blood pressure, tachycardia, dia-phoresis, and cardiac dysrhythmia). Associated features can include ele-vatedserumcreatinephosphokinase(CPK)concentration,rhabdomyoly-sis, elevated serum and urine myoglobin concentration, and renal failure. NMS did not occur in the ADASUVE clinical program.The diagnostic evaluation of patients with this syndrome is complicated. It is important to consider the presence of other serious medical con-ditions (e.g.,pneumonia,systemic infection,heatstroke,primaryCNSpathology, central anticholinergic toxicity, extrapyramidal symptoms, or drug fever). The management of NMS should include: 1) immediate discontinua-tion of antipsychotic drugs and other drugs that may contribute to the underlying disorder, 2) intensive symptomatic treatment and medical mon-itoring, and 3) treatment of any concomitant serious medical problems. There is no general agreement about specific pharmacological treatment regimens for NMS.If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported. 5.5 Hypotension and SyncopeADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use ADASUVE with caution in patients with known cardiovascular dis-ease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or condi-tions that would predispose patients to hypotension (dehydration, hypo-volemia, or treatment with antihypertensive medications or other drugs that affect blood pressure or reduce heart rate).In the presence of severe hypotension requiring vasopressor therapy, the preferred drugs may be norepinephrine or phenylephrine. Epinephrine should not be used, because beta stimulation may worsen hypotension in the setting of ADASUVE-induced partial alpha blockade.In short-term (24-hour) placebo-controlled trials of patients with agitation associated with schizophrenia or bipolar I disorder, hypotension occurred in 0.4% and 0.8% in the ADASUVE 10 mg and placebo groups, respec-tively. There were no cases of orthostatic hypotension, postural symptoms,
Table 1. Adverse Reactions in 3 Pooled Short-Term, Placebo-Controlled Trials (Studies 1, 2, and 3) in Patients with Schizophrenia or Bipolar Disorder
Adverse ReactionPlacebo(n = 263)
ADASUVE(n = 259)
Dysgeusia 5% 14%Sedation 10% 12%Throat Irritation 0% 3%
Airway Adverse Reactions in the 3 Trials in Acute Agitation Agitated patients with Schizophrenia or Bipolar Disorder: In the 3 short-term (24-hour), placebo-controlled trials in patients with agitation asso-ciated with schizophrenia or bipolar disorder (Studies 1, 2, and 3), bron-chospasm (which includes reports of wheezing, shortness of breath and cough) occurred more frequently in the ADASUVE group, compared to the placebo group: 0% (0/263) in the placebo group and 0.8% (2/259) intheADASUVE10mggroup.Onepatientwithschizophrenia,withouta history of pulmonary disease, had significant bronchospasm requiring rescue treatment with a bronchodilator and oxygen. Bronchospasm and Airway Adverse Reactions in Pulmonary Safety TrialsClinicalpulmonarysafetytrialsdemonstratedthatADASUVEcancausebronchospasm as measured by FEV1, and as indicated by respiratory signs and symptoms in the trials. In addition, the trials demonstrated thatpatientswithasthmaorotherpulmonarydiseases,suchasCOPDare at increased risk of bronchospasm. The effect of ADASUVE on pulmonary function was evaluated in 3 randomized, double-blind, placebo-controlled clinical pulmonary safety trials in healthy volunteers, patientswithasthma,andpatientswithCOPD.Pulmonaryfunctionwasassessed by serial FEV1 tests, and respiratory signs and symptoms were assessed.IntheasthmaandCOPDtrials,patientswithrespiratorysymp-toms or FEV1 decrease of ≥ 20% were administered rescue treatment with albuterol (metered dose inhaler or nebulizer) as required. These patientswerenoteligibleforaseconddose;however,theyhadcontinuedFEV1 monitoring in the trial. HealthyVolunteers: In the healthy volunteer crossover trial, 30 subjects received 2 doses of either ADASUVE or placebo 8 hours apart, and 2 doses of the alternate treatment at least 4 days later. The results for maximum decrease in FEV1 are presented in Table 2. No subjects in this trial devel-oped airway related adverse reactions (cough, wheezing, chest tightness, or dyspnea).Asthma Patients: In the asthma trial, 52 patients with mild-moderate persistent asthma (with FEV1 ≥ 60% of predicted) were randomized to treatment with 2 doses of ADASUVE 10 mg or placebo. The second dose was to be administered 10 hours after the first dose. Approximately 67% of these patients had a baseline FEV1 ≥ 80% of predicted. The remaining patients had an FEV1 60-80% of predicted. Nine patients (17%) were former smokers. As shown in Table 2 and Figure 7, there was a marked decrease in FEV1 immediately following the first dose (maximum mean decreases in FEV1 and % predicted FEV1 were 303 mL and 9.1%, respec-tively). Furthermore, the effect on FEV1 was greater following the second dose (maximum mean decreases in FEV1 and % predicted FEV1 were 537 mL and 14.7 %, respectively). Respiratory-related adverse reactions (bronchospasm, chest discomfort, cough, dyspnea, throat tightness, and wheezing) occurred in 54% of ADASUVE-treated patients and 12% of placebo-treated patients. There were no serious adverse events. Nine of 26 (35%) patients in the ADASUVE group, compared to one of 26 (4%) in the placebo group, did not receive a second dose of study medication, because they had a ≥ 20% decrease in FEV1 or they developed respiratory symptoms after the first dose. Rescue medication (albuterol via metered dose inhaler or nebulizer) was administered to 54% of patients in the ADASUVE group [7 patients (27%) after the first dose and 7 of the remain-ing 17 patients (41%) after the second dose] and 12% in the placebo group (1 patient after the first dose and 2 patients after the second dose).COPDPatients:IntheCOPDtrial,53patientswithmildtosevereCOPD(withFEV1 ≥ 40% of predicted) were randomized to treatment with 2 doses of ADASUVE 10 mg or placebo. The second dose was to be administered 10 hours after the first dose. Approximately 57% of these patients had moderateCOPD[Global Initiative forChronicObstructiveLungDisease(GOLD)StageII];32%hadseveredisease(GOLDStageIII);and11%hadmilddisease(GOLDStageI).AsillustratedinTable2therewasadecreasein FEV1 soon after the first dose (maximum mean decreases in FEV1 and % predicted FEV1 were 96 mL and 3.5%, respectively), and the effect on FEV1 was greater following the second dose (maximum mean decreases in FEV1 and % predicted FEV1 were 125 mL and 4.5%, respectively). Respi-ratory adverse reactions occurred more frequently in the ADASUVE group (19%) than in the placebo group (11%). There were no serious adverse events. Seven of 25 (28%) patients in the ADASUVE group and 1of 27 (4%) in the placebo group did not receive a second dose of study medication because of a ≥ 20% decrease in FEV1 or the development of respiratory symptoms after the first dose. Rescue medication (albuterol via MDI or
presyncope or syncope. A systolic blood pressure ≤90mmHgwithadecrease of ≥20mmHgoccurredin1.5%and0.8%oftheADASUVE10 mg and placebo groups, respectively. A diastolic blood pressure ≤50mmHgwithadecreaseof≥15mmHgoccurredin0.8%and0.4%of the ADASUVE 10 mg and placebo groups, respectively.In 5 Phase 1 studies in normal volunteers, the incidence of hypotension was 3% and 0% in ADASUVE 10 mg and the placebo groups, respec-tively. The incidence of syncope or presyncope in normal volunteers was 2.3% and 0% in the ADASUVE and placebo groups, respectively. In nor-mal volunteers, a systolic blood pressure ≤90mmHgwithadecreaseof ≥20mmHgoccurredin5.3%and1.1%intheADASUVEandplacebogroups, respectively. A diastolic blood pressure ≤ 50 mm Hg with adecrease of ≥15mmHgoccurredin7.5%and3.3%intheADASUVEandplacebo groups, respectively.5.6 SeizuresADASUVE lowers the seizure threshold. Seizures have occurred in patients treated with oral loxapine. Seizures can occur in epileptic patients even during antiepileptic drug maintenance therapy. In short term (24 hour), placebo-controlled trials of ADASUVE, there were no reports of seizures. 5.7 Potential for Cognitive and Motor ImpairmentADASUVE can impair judgment, thinking, and motor skills. In short-term, placebo-controlled trials, sedation and/or somnolence were reported in 12% and 10% in the ADASUVE and placebo groups, respectively. No patients discontinued treatment because of sedation or somnolence.The potential for cognitive and motor impairment is increased when ADASUVEisadministeredconcurrentlywithotherCNSdepressants[see Drug Interactions (7.1)]. Caution patients about operating hazardousmachinery, including automobiles, until they are reasonably certain that therapy with ADASUVE does not affect them adversely. 5.8 Cerebrovascular Reactions, Including Stroke, in Elderly Patients with Dementia-Related PsychosisIn placebo-controlled trials with atypical antipsychotics in elderly patients with dementia-related psychosis, there was a higher incidence of cere-brovascular adverse reactions (stroke and transient ischemic attacks), including fatalities, compared to placebo-treated patients. ADASUVE is not approved for the treatment of patients with dementia-related psycho-sis [see Boxed Warning and Warnings and Precautions (5.3)].5.9 Anticholinergic Reactions Including Exacerbation of Glaucoma and Urinary RetentionADASUVE has anticholinergic activity, and it has the potential to cause anticholinergic adverse reactions including exacerbation of glaucoma or urinary retention. The concomitant use of other anticholinergic drugs (e.g., antiparkinson drugs) with ADASUVE could have additive effects. 6 ADVERSE REACTIONSThe following adverse reactions are discussed in more detail in other sections of the labeling:• Hypersensitivity(seriousskinreactions)[see Contraindications (4)] • Bronchospasm[see Warnings and Precautions (5.1)]• IncreasedMortalityinElderlyPatientswithDementia-RelatedPsycho-
sis [see Warnings and Precautions (5.3)]• NeurolepticMalignantSyndrome[see Warnings and Precautions (5.4)]• Hypotensionandsyncope[see Warnings and Precautions (5.5)]• Seizure[see Warnings and Precautions (5.6)]• Potential forCognitiveandMotorImpairment[see Warnings and Pre-
cautions (5.7)]• CerebrovascularReactions, IncludingStroke, inElderlyPatientswith
Dementia-Related Psychosis [see Warnings and Precautions (5.8)]• AnticholinergicReactionsIncludingExacerbationofGlaucomaandUri-
nary Retention [see Warnings and Precautions (5.9)]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.The following findings are based on pooled data from three short-term (24-hour), randomized, double-blind, placebo-controlled clinical trials (Studies 1, 2, and 3) of ADASUVE 10 mg in the treatment of patients with acute agitation associated with schizophrenia or bipolar I disorder. In the 3 trials, 259 patients received ADASUVE 10 mg, and 263 received placebo [see Clinical Studies (14)].Commonly Observed Adverse Reactions: In the 3 trials in acute agita-tion, the most common adverse reactions were dysgeusia, sedation, and throat irritation. These reactions occurred at a rate of at least 2% of the ADASUVE group and at a rate greater than in the placebo group. (Refer to Table 1).
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nebulizer) was administered to 23% of patients in the ADASUVE group: 8% of patients after the first dose and 21% of patients after the second dose, and to 15% of patients in the placebo group.Table 2: Maximum Decrease in FEV1 from Baseline in the Healthy Volun-teer, Asthma, and COPD Trials
Healthy Volunteer Asthma COPDMaximum% FEV ↓
Placebon (%)
ADASUVE10 mgn (%)
Placebon (%)
ADASUVE10 mgn (%)
Placebon (%)
ADASUVE10 mgn (%)
After any Dose
N=26 N=26 N=26 N=26 N=27 N=25
≥10 7 (27) 7 (27) 3 (12) 22 (85) 18 (67) 20 (80)
≥15 1 (4) 5 (19) 1 (4) 16 (62) 9 (33) 14 (56)
≥20 0 1 (4) 1 (4) 11 (42) 3 (11) 10 (40)
After Dose 1
N=26 N=26 N=26 N=26 N=27 N=25
≥10 4 (15) 5 (19) 2 (8) 16 (62) 8 (30) 16 (64)
≥15 1 (4) 2 (8) 1 (4) 8 (31) 4 (15) 10 (40)
≥20 0 0 1 (4) 6 (23) 2 (7) 9 (36)
After Dose 2
N=26 N=25 N=25 N=17 N=26 N=19
≥10 5 (19) 6 (24) 3 (12) 12 (71) 15 (58) 12 (63)
≥15 0 5 (20) 1 (4) 9 (53) 6 (23) 10 (53)
≥20 0 1 (4) 1 (4) 5 (30) 1 (4) 5 (26)
FEV1categoriesarecumulative;i.e.asubjectwithamaximumdecreaseof 21% is included in all 3 categories. Patients with a ≥ 20% decrease in FEV1 did not receive a second dose of study drug.Figure 7: LS Mean Change from Baseline in FEV1 in Patients with Asthma
Patients with a ≥ 20% decrease in FEV1 did not receive a second dose of study drug and are not included in the curves beyond hour 10.Extrapyramidal Symptoms (EPS): Extrapyramidal reactions have occurred during the administration of oral loxapine. In most patients, these reactions involved parkinsonian symptoms such as tremor, rigidity, and masked facies. Akathisia (motor restlessness) has also occurred.In the 3 short-term (24-hour), placebo-controlled trials of ADASUVE in 259 patients with agitation associated with schizophrenia or bipolar disorder, extrapyramidalreactionsoccurred.Onepatient(0.4%)treatedwithADASUVEdeveloped neck dystonia and oculogyration. The incidence of akathisia was 0% and 0.4% in the placebo and ADASUVE groups, respectively. Dystonia (Antipsychotic Class Effect): Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible indi-viduals during treatment with ADASUVE. Dystonic symptoms include spasm of the neck muscles, sometimes progressing to tightness of the throat, difficulty swallowing or breathing, and/or protrusion of the tongue. Acute dystonia tends to be dose-related, but can occur at low doses, and occurs more frequently with first generation antipsychotic drugs such as ADASUVE. The risk is greater in males and younger age groups.Cardiovascular Reactions: Tachycardia, hypotension, hypertension, ortho-static hypotension, lightheadedness, and syncope have been reported with oral administration of loxapine.7 DRUG INTERACTIONS7.1 CNS DepressantsADASUVEisacentralnervoussystem(CNS)depressant.TheconcurrentuseofADASUVEwithotherCNSdepressants(e.g.,alcohol,opioidanal-gesics, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines,sedative/hypnotics,musclerelaxants,and/or illicitCNSdepressants) can increase the risk of respiratory depression, hypoten-sion, profound sedation, and syncope. Therefore, consider reducing the doseofCNSdepressantsifusedconcomitantlywithADASUVE.
7.2 Anticholinergic DrugsADASUVE has anticholinergic activity. The concomitant use of ADASUVE and other anticholinergic drugs can increase the risk of anticholinergic adverse reactions including exacerbation of glaucoma and urinary retention.8 USE IN SPECIFIC POPULATIONSIn general, no dose adjustment for ADASUVE is required on the basis of a patient’s age, gender, race, smoking status, hepatic function, or renal function.8.1 PregnancyPregnancyCategoryCRisk SummaryThere are no adequate and well-controlled studies of ADASUVE use in pregnant women. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or with-drawal symptoms following delivery. Loxapine, the active ingredient in ADASUVE, has demonstrated increased embryofetal toxicity and death in rat fetuses and offspring exposed to doses approximately 0.5-fold themaximum recommendedhumandose (MRHD) on amg/m2 basis. ADASUVE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.HumanDataNeonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypo-tonia, tremor, somnolence, respiratory distress, and feeding disorders intheseneonates.Thesecomplicationshavevariedinseverity;insomecases symptoms have been self-limited, but in other cases neonates have required intensive care unit support and prolonged hospitalization.Animal DataIn rats, embryofetal toxicity (increased fetal resorptions, reduced weights, and hydronephrosis with hydroureter) was observed following oral administration of loxapine during the period of organogenesis at a doseof1mg/kg/day.ThisdoseisequivalenttotheMRHDof10mg/dayon a mg/m2 basis. In addition, fetal toxicity (increased prenatal death, decreased postnatal survival, reduced fetal weights, delayed ossifica-tion, and/or distended renal pelvis with reduced or absent papillae) was observed following oral administration of loxapine from mid-pregnancy through weaning at doses of 0.6 mg/kg and higher. This dose is approxi-matelyhalftheMRHDof10mg/dayonamg/m2 basis. No teratogenicity was observed following oral administration of loxapine during the period of organogenesis in the rat, rabbit, or dog at doses up to 12, 60, and 10 mg/kg, respectively. These doses are approximately 12-, 120-,and32-foldtheMRHDof10mg/dayonamg/m2 basis, respectively.8.3 Nursing Mothers It is not known whether ADASUVE is present in human milk. Loxapine and its metabolites are present in the milk of lactating dogs. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ADASUVE, a decision should be made whether to discontinue nursing or discontinue ADASUVE, taking into account the importance of the drug to the mother.8.4 Pediatric UseThe safety and effectiveness of ADASUVE in pediatric patients have not been established.8.5 Geriatric UseElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Boxed Warning and Warn-ings and Precautions (5.3)]. ADASUVE is not approved for the treatment of dementia-related psychosis. Placebo-controlled studies of ADASUVE in patients with agitation associated with schizophrenia or bipolar disorder did not include patients over 65 years of age.10 OVERDOSAGESigns and Symptoms of OverdosageAs would be expected from the pharmacologic actions of loxapine, the clinicalfindingsmayincludeCNSdepression,unconsciousness,profoundhypotension, respiratory depression, extrapyramidal symptoms, and seizure.Management of OverdosageFor the most up to date information on the management of ADASUVE overdosage, contact a certified poison control center (1-800-222-1222 or www.poison.org). Provide supportive care including close medical supervision and monitoring. Treatment should consist of general mea-suresemployedinthemanagementofoverdosagewithanydrug.Con-sider the possibility of multiple drug overdosage. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures.Manufacturedby:AlexzaPharmaceuticals,Inc.,MountainView,CA94043Manufacturedfor:TevaSelectBrands,Horsham,PA19044,DivisionofTeva Pharmaceuticals USA, Inc.Iss.12/2013ADA-40059
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nebulizer) was administered to 23% of patients in the ADASUVE group: 8% of patients after the first dose and 21% of patients after the second dose, and to 15% of patients in the placebo group.Table 2: Maximum Decrease in FEV1 from Baseline in the Healthy Volun-teer, Asthma, and COPD Trials
Healthy Volunteer Asthma COPDMaximum% FEV ↓
Placebon (%)
ADASUVE10 mgn (%)
Placebon (%)
ADASUVE10 mgn (%)
Placebon (%)
ADASUVE10 mgn (%)
After any Dose
N=26 N=26 N=26 N=26 N=27 N=25
≥10 7 (27) 7 (27) 3 (12) 22 (85) 18 (67) 20 (80)
≥15 1 (4) 5 (19) 1 (4) 16 (62) 9 (33) 14 (56)
≥20 0 1 (4) 1 (4) 11 (42) 3 (11) 10 (40)
After Dose 1
N=26 N=26 N=26 N=26 N=27 N=25
≥10 4 (15) 5 (19) 2 (8) 16 (62) 8 (30) 16 (64)
≥15 1 (4) 2 (8) 1 (4) 8 (31) 4 (15) 10 (40)
≥20 0 0 1 (4) 6 (23) 2 (7) 9 (36)
After Dose 2
N=26 N=25 N=25 N=17 N=26 N=19
≥10 5 (19) 6 (24) 3 (12) 12 (71) 15 (58) 12 (63)
≥15 0 5 (20) 1 (4) 9 (53) 6 (23) 10 (53)
≥20 0 1 (4) 1 (4) 5 (30) 1 (4) 5 (26)
FEV1categoriesarecumulative;i.e.asubjectwithamaximumdecreaseof 21% is included in all 3 categories. Patients with a ≥ 20% decrease in FEV1 did not receive a second dose of study drug.Figure 7: LS Mean Change from Baseline in FEV1 in Patients with Asthma
Patients with a ≥ 20% decrease in FEV1 did not receive a second dose of study drug and are not included in the curves beyond hour 10.Extrapyramidal Symptoms (EPS): Extrapyramidal reactions have occurred during the administration of oral loxapine. In most patients, these reactions involved parkinsonian symptoms such as tremor, rigidity, and masked facies. Akathisia (motor restlessness) has also occurred.In the 3 short-term (24-hour), placebo-controlled trials of ADASUVE in 259 patients with agitation associated with schizophrenia or bipolar disorder, extrapyramidalreactionsoccurred.Onepatient(0.4%)treatedwithADASUVEdeveloped neck dystonia and oculogyration. The incidence of akathisia was 0% and 0.4% in the placebo and ADASUVE groups, respectively. Dystonia (Antipsychotic Class Effect): Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible indi-viduals during treatment with ADASUVE. Dystonic symptoms include spasm of the neck muscles, sometimes progressing to tightness of the throat, difficulty swallowing or breathing, and/or protrusion of the tongue. Acute dystonia tends to be dose-related, but can occur at low doses, and occurs more frequently with first generation antipsychotic drugs such as ADASUVE. The risk is greater in males and younger age groups.Cardiovascular Reactions: Tachycardia, hypotension, hypertension, ortho-static hypotension, lightheadedness, and syncope have been reported with oral administration of loxapine.7 DRUG INTERACTIONS7.1 CNS DepressantsADASUVEisacentralnervoussystem(CNS)depressant.TheconcurrentuseofADASUVEwithotherCNSdepressants(e.g.,alcohol,opioidanal-gesics, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines,sedative/hypnotics,musclerelaxants,and/or illicitCNSdepressants) can increase the risk of respiratory depression, hypoten-sion, profound sedation, and syncope. Therefore, consider reducing the doseofCNSdepressantsifusedconcomitantlywithADASUVE.
7.2 Anticholinergic DrugsADASUVE has anticholinergic activity. The concomitant use of ADASUVE and other anticholinergic drugs can increase the risk of anticholinergic adverse reactions including exacerbation of glaucoma and urinary retention.8 USE IN SPECIFIC POPULATIONSIn general, no dose adjustment for ADASUVE is required on the basis of a patient’s age, gender, race, smoking status, hepatic function, or renal function.8.1 PregnancyPregnancyCategoryCRisk SummaryThere are no adequate and well-controlled studies of ADASUVE use in pregnant women. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or with-drawal symptoms following delivery. Loxapine, the active ingredient in ADASUVE, has demonstrated increased embryofetal toxicity and death in rat fetuses and offspring exposed to doses approximately 0.5-fold themaximum recommendedhumandose (MRHD) on amg/m2 basis. ADASUVE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.HumanDataNeonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypo-tonia, tremor, somnolence, respiratory distress, and feeding disorders intheseneonates.Thesecomplicationshavevariedinseverity;insomecases symptoms have been self-limited, but in other cases neonates have required intensive care unit support and prolonged hospitalization.Animal DataIn rats, embryofetal toxicity (increased fetal resorptions, reduced weights, and hydronephrosis with hydroureter) was observed following oral administration of loxapine during the period of organogenesis at a doseof1mg/kg/day.ThisdoseisequivalenttotheMRHDof10mg/dayon a mg/m2 basis. In addition, fetal toxicity (increased prenatal death, decreased postnatal survival, reduced fetal weights, delayed ossifica-tion, and/or distended renal pelvis with reduced or absent papillae) was observed following oral administration of loxapine from mid-pregnancy through weaning at doses of 0.6 mg/kg and higher. This dose is approxi-matelyhalftheMRHDof10mg/dayonamg/m2 basis. No teratogenicity was observed following oral administration of loxapine during the period of organogenesis in the rat, rabbit, or dog at doses up to 12, 60, and 10 mg/kg, respectively. These doses are approximately 12-, 120-,and32-foldtheMRHDof10mg/dayonamg/m2 basis, respectively.8.3 Nursing Mothers It is not known whether ADASUVE is present in human milk. Loxapine and its metabolites are present in the milk of lactating dogs. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ADASUVE, a decision should be made whether to discontinue nursing or discontinue ADASUVE, taking into account the importance of the drug to the mother.8.4 Pediatric UseThe safety and effectiveness of ADASUVE in pediatric patients have not been established.8.5 Geriatric UseElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Boxed Warning and Warn-ings and Precautions (5.3)]. ADASUVE is not approved for the treatment of dementia-related psychosis. Placebo-controlled studies of ADASUVE in patients with agitation associated with schizophrenia or bipolar disorder did not include patients over 65 years of age.10 OVERDOSAGESigns and Symptoms of OverdosageAs would be expected from the pharmacologic actions of loxapine, the clinicalfindingsmayincludeCNSdepression,unconsciousness,profoundhypotension, respiratory depression, extrapyramidal symptoms, and seizure.Management of OverdosageFor the most up to date information on the management of ADASUVE overdosage, contact a certified poison control center (1-800-222-1222 or www.poison.org). Provide supportive care including close medical supervision and monitoring. Treatment should consist of general mea-suresemployedinthemanagementofoverdosagewithanydrug.Con-sider the possibility of multiple drug overdosage. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures.Manufacturedby:AlexzaPharmaceuticals,Inc.,MountainView,CA94043Manufacturedfor:TevaSelectBrands,Horsham,PA19044,DivisionofTeva Pharmaceuticals USA, Inc.Iss.12/2013ADA-40059
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ENA will redefine the idea of a
winning hand next February when
it holds the State and Chapter Leaders
Orientation, a focused two-day event
for all 2015 officers and core
leaders at the Paris Hotel in Las
Vegas — a frequently requested
city for ENA events.
The orientation previously
was known as the State and
Chapter Leaders Conference
and had in recent years been a
lead-in to the ENA Leadership
Conference, the last of which
was this year in Phoenix. ENA switches
to one larger conference, Emergency
Nursing 2015, beginning next fall.
All state council and chapter officers
and core leaders — that includes
government affairs chairs, membership
chairs and any other core leaders —
are strongly encouraged to attend the
orientation Feb. 19-20. Registration
begins in November, with information
to be sent to all 2015 leaders who are
reported in the State Council and
Chapter Online Management System.
Matthew F. Powers, MS, BSN, RN,
MICP, CEN, the 2015 ENA president,
said there’s no better way to
understand the roles, responsibilities
and processes of ENA and how your
state council or chapter connects,
especially if you’re new to the job.
‘‘The No. 1 reason to attend your
state and chapter leaders orientation
would be to learn more about your
professional organization and what
and who ENA is, and what it stands
for,’’ Powers said. ‘‘This orientation is
really focused for our member leaders,
and we’ll be able to focus our time
and energy solely toward the
orientation process vs. previously
concentrating on state leaders and our
leadership conference.’’
State and chapter leaders will learn
about ENA governance guidelines and
the strategic plan of the ENA Board of
Directors to make sure their units and
national ENA are running in
sync. There will be specific
sessions on finances,
association law, meeting
management, conference
planning, member engagement
and social media, along with
dynamic general session
speakers. Advocacy and
government relations will be
key parts of the program — ‘‘how to
get more involved in changing law,
statute and regulation at your local,
state and national level,’’ Powers said.
In short, the orientation is about
resources and, just as important, face
time with the people providing them.
Powers, who attended his first ENA
conference in 2002 and became
president of the East Bay (Calif.)
Chapter the next year before rising
through the California ENA State
Council, knows how important these
resources are to both seasoned and
new leaders. The emergence of new
ENA leaders each year is ‘‘amazing,’’
he said.
‘‘It’s seeing the passion in new
faces, seeing new people that want to
get involved and make a difference,
and to be able to really get the best
out of the best from our members’
talent and experience,’’ Powers said.
‘‘You are able to see their eyes light
up. They get revitalized, they get very
involved, and I think our challenge is
to keep that motivation going
throughout the year.’’
Mari Hoover-McGarry, RN, CEN,
CCRN, is a veteran of ENA orientations
and calls them ‘‘an energizing
environment.’’ As treasurer for the
Palm Beach County (Fla.) Chapter and
a past president and treasurer of the
Florida ENA State Council, she stressed
the importance of networking and
becoming clear on fiduciary rules,
particularly nonprofit tax status and
how it governs advocacy efforts with
politicians.
It’s also great team-building, she
said, both nationally with your board
liaison and within your state.
‘‘It helps put you on the front lines
with the ENA staff and the national
board members,’’ she said. ‘‘And it’s
nice to incorporate some social time
with your state leaders because we all
come from various parts of the state
— we don’t all live in one small
geographic location.’’
State and Chapter Leaders OrientationWhen: Feb. 19-20, 2015 – Paris Hotel, Las Vegas
Signing up: Registration starts in November at www.ena.org; 2015 leaders in the Online Management System will receive a formal invitation. Registration, CE, breakfast and lunch are complimentary. Hotel, airfare and dinner expenses are not covered.
Pre-orientation resources:tinyurl.com/ENAofficers
tinyurl.com/ENAstateschapters
Full program coming soon at www.ena.org.
Official Magazine of the Emergency Nurses Association 23
WHAT HAPPENS IN VEGASBy Josh Gaby, ENA Connection
HELPS EVERYONE
Matthew F. Powers
October 201424
By Kendra Y. Mims, ENA Connection
Stacey Cernadas, ADN, RN, EMT, had
traveled the world as an
international flight attendant for almost
nine years when she decided to
quit her job to pursue a career
in nursing. Even though it was
her third career change, the
former pre-med student knew
the nursing profession was
where she belonged.
She had always wanted to
work in the medical field — she
just had to find her way back to
it. She first was drawn to nursing at age
12 when her stepfather suffered a
massive heart attack.
‘‘He had a quadruple bypass when
he was my current age [36],’’ Cernadas
said. ‘‘I remember going through that
experience and seeing the care the
nurses provided to our family and the
patient advocacy. I remember very
vividly how great it was and how
life-changing that event was for my
family and for me at a young age. It’s
one of those things that has been a
very large part of my life.’’
The experience was one of
Cernadas’ main motivators when she
enrolled in nursing school in 2010. She
initially wanted to be a labor and
delivery nurse until her mentor
encouraged her to try emergency
nursing. As soon as she decided to
precept in the emergency department,
she fell in love and never looked back.
‘‘I knew it immediately,’’ she said.
‘‘I’m very calm and collected, and
there’s not much that can get me
flustered or stressed, so being able to
stay calm and relaxed in emergency
situations was something I found really
soothing. It fit me perfectly.
‘‘I really feel like it’s what I was put
here to do. It’s natural to me. I feel at
ease and like emergency
nursing is where I’m supposed
to be. I look forward to the
many years of making a
difference in this profession.’’
Cernadas has now been an
emergency nurse for 16
months and works at Baptist
Medical Center South in
Montgomery, Ala., where she was
encouraged to join ENA by Leigh
Parker, BSN, RN, CEN, the Alabama
ENA State Council president.
‘‘Leigh was one of my charge
nurses, and she took me under her
wing and gave me goals to fulfill,’’
Cernadas said. ‘‘She’s been a really
good mentor and introduced me to
ENA very early in my career.’’
Cernadas attended her first ENA
Annual Conference last year in
Nashville after being selected to
participate in the TNCC pilot course.
‘‘It was amazing,’’ she said. ‘‘I was
so enthralled by everything that was
going on. There were so many sessions
available, and it was really awesome
being able to choose educational
sessions to attend. Everyone was very
receptive. It was a nice brotherhood
and sisterhood of nurses, and I felt like
it was like my family.’’
Parker also encouraged Cernadas to
apply for an ENA Foundation
professional development scholarship
to attend the 2014 ENA Annual
Conference in Indianapolis. There are
19 of these $500 scholarships this year,
intended to reduce the conference cost
and travel expenses for ENA members
who would otherwise be unable to
attend. When Cernadas received the
call that she would be awarded one,
she screamed in excitement.
‘‘I’m really thrilled, and I take this
opportunity seriously,’’ she said. ‘‘I get
to hear amazing speakers all day long,
and at the end of the day, I have great
CE credits. I’m looking forward to the
educational sessions. I also get to see
all of the vendors at the exhibit hall
and the new things that are coming out
on the market that I can take back to
work. I’m just so excited.’’
Cernadas encourages emergency
nurses to give back to the ENA
Foundation to contribute to colleagues’
professional development and growth.
‘‘I think it’s very important to donate
and give back because it lets us create
and evolve our ENA nurses as the
times pass,’’ she said. ‘‘If we don’t give
back, then we are not showing our
appreciation to the incoming nurses,
SENTENA FOUNDATION
Helped by $500 Annual Conference Scholarship,This Emergency Nurse Will Keep Going Places
WITH LOVE
Stacey Cernadas was in Nashville last year for the 2013 ENA Annual Conference and gets to return this year with scholarship assistance.Stacey Cernadas
Official Magazine of the Emergency Nurses Association 25
and we are not willing to help mold
them and make them the best they can
be. You’re only as strong as your
weakest link, so I think it’s very
important for us to carry and put those
values into the newer nurses and the
nurses who want to continue their
education. I really want to make sure
that everyone is pushed to do
everything that they can and be the
best that they can be.’’
2014 Scholarship and Research Grant RecipientsThe ENA Foundation would like to
extend a special thank-you to the
individuals, state councils, local
chapters, industry, ENA staff and
friends of emergency nursing who
have supported the profession through
their generous donations. Because of
your contributions and passion to
promote the advancement of the
profession, our applicants are afforded
the opportunity to receive educational
scholarships and research grants in the
discipline of emergency nursing.
The ENA Foundation is excited to
announce the following 2014
scholarship and research grant
recipients and share how our donors
are making a difference:
Academic Scholarship RecipientsNon-RN Scholarships
•New York State ENA September 11 Scholarships – $2,500 each
Sean Davenport, CCEMT-P, Kentucky Margaret T. Swenson, EMT, Utah
• ENA Foundation Emergency Department Employee Scholarships – $2,500 each
Emily Carle, EMT, Maine Amanda Smith, Florida
•Hill-Rom Scholarship – $2,500
William S. Guban, EMT-B, Vermont
Undergraduate Scholarships•Charles Kunz Memorial Undergraduate Scholarship – $3,000
Pamela D. Bartley, BS, RN, CCRN, CEN, CPEN, South Carolina
•Physio-Control Inc. Scholarship – $3,000 each Jacquelyn Glendinning, RN, New York Linda Murray, RN, Kentucky
Graduate Scholarships•Stryker Masters in Healthcare Scholarship – $5,000 Jody L. Bauer, BSN, RN, Texas
•Teleflex Scholarship – $5,000 Danita Mullins, BSN, RN, CEN, Arkansas
•Judith C. Kelleher Memorial Scholarship – $5,000 Lori Bannon, BSN, RN, Virginia
•Martha C. Wood Scholarship – $6,500 Erin S. Aston, BSN, RN, CPEN, North Carolina
•California State Council – Antoinette Robinson Scholarship – $5,000 Petra Coronado, BSN, RN, CEN, California
As a donor, you can make a difference in the future of emergency nursing. Your donation will help to provide funding for research that can improve the quality of patient care, build future leaders, support education that can change the practice of medicine in the future and much more. If you would like to join others in making a difference in emergency nursing, the ENA Foundation has opportunities for you to become involved. Visit www.enafoundation.org to find out how you can contribute to advancing emergency nursing.
Continued on next page
Learning opportunities at ENA conferences are only the beginning for emergency nurses looking to advance their educations, and the ENA Foundation is here to help.
October 201426
Thank you to the following organizations for
their generous support.
The ENA Strategic Sponsorship Program is designed to create partnerships with leading organizations whose objectives
include supporting the emergency nursing profession.
STRATEGIC SPONSORS
STRATEGIC SUPPORTER
Sponsorship Ad_Connection_half vert_08 2014.indd 1 6/25/14 3:48 PM
•Colorado State Council – Aurora Shooting Victims and Care Providers Scholarship – $5,000 Elizabeth Wolotira, BSN, RN, CEN, CPEN, CFRN, Oregon
•Georgia ENA State Council – Georgia State Council Scholarship – $5,000 Carrie L. Malone, BSN, RN, CEN, Indiana
•Illinois State Council – Illinois State Council Scholarship – $5,000 Susan Remaly, BSN, RN, CEN, Illinois
•Kentucky State Council – Kentucky ENA Founders Scholarship – $5,000 Kathy Tussey, BSN, RN, CEN, Kentucky
•Maryland State Council – Maryland ENA State Council Scholarship – $5,000 Jennifer A. Bishop, BSN, RN, CEN, Pennsylvania
•Michigan ENA State Council – Michigan State Council Scholarship – $5,000 Jo M. Tabler, BSN, RN, CEN, CFRN, Indiana
•Minnesota State Council – “Pathways VI” Scholarship – $5,000 Pamela Sue Jenkins, BSN, RN, CPEN, Pennsylvania
•New Jersey State Council – New Jersey State Challenge Scholarship – $5,000
Valerie Jackson, BSN, RN, FNE, Indiana
•Northern Chapter (NJ) – Mary Kamienski Scholarship – $5,000 Katie M. Bush, MA, RN, CEN, SANE-A, Ohio
•West Central Chapter (NJ) – Jeanette Ash Memorial Scholarship – $5,000 Andrea Helman, BSN, RN, CEN, Illinois
•South Carolina State Council – The Survivor Scholarship – $5,000 Peter Giordano, BSN, RN, CEN, Illinois
• Tennessee State Council – Brent Lemonds Memorial Scholarship – $5,000 Lynette Fair, BSN, Pennsylvania
Continued on next page
ENA Foundation Scholarships and Research Grants Continued from previous page
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October 201428
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www.ena.org/GENE
The Emergency Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
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•Texas State Council – Vicki Patrick Texas Legacy Scholarship – $5,000
Josie Boyle, BSN, RN, CEN, Oregon
•ENA Foundation State Challenge Scholarships – $5,000 each
Melissa Beans, BSN, Pennsylvania Emma Dragon, BSN, RN, CEN, EMT-B, Massachusetts Debra Kitchens, BSN, RN, CEN, NRP, South Carolina Melissa Kolarik, BSN, CEN, CFRN, Illinois Anne M. LeGare, BSN, RN, Wisconsin
•Gisness Advance Practice Scholarship – $3,000
Kathy Tussey, BSN, RN, CEN, Kentucky
•Karen O’Neil Memorial Scholarship – $3,000
Danita Mullins, BSN, RN, CEN, Arkansas
Doctoral Scholarships•Pamela Stinson Kidd Memorial Doctoral Scholarship – $10,000
Lisa M. Eckenrode, MSN, MBA, RN, NREMT-P, Pennsylvania
•ENA Foundation State Challenge Doctoral Scholarships – $5,000 each
Meredith J. Addison, MSN, RN, CEN, Indiana Tobin Miller, MSN, RN, CEN, CCRN, California Elizabeth R. Tedesco, MSN, RN, CEN, Pennsylvania
•ENA Foundation Doctoral Scholarship – $4,000
Cory Church, MSN, RN, Texas
•Hill-Rom Doctoral Scholarship – $2,500 Meredith J. Addison, RN, MSN, CEN, Indiana
Continuing Education Scholarships•Leadership Tapestry Conference Scholarships – $1,000 each
Erin Aston, BSN, RN, CPEN, North Carolina Danielle Bonca, BSN, RN, Nevada Molly Delaney, PhD, MBA, MNS, RN, CEN, CPEN, Minnesota Angela J. Hodge, MSN, RN, ACNS, CEN, EMT-P, Ohio Kelly Mills, BSN, RN, CEN, Indiana Rebekah Schelhaas, RN, CEN, South Dakota Ann B. Townsend, DNS, RN, ANP-BC, New Jersey Jessica A. Trivett, MSN, RN, CEN, New Jersey
Scholarships and Research Grants Continued from previous page
Official Magazine of the Emergency Nurses Association 29
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•ENA Foundation Annual Conference Scholarships – $500 each Tiffany Alves, MS, CNS, CEN, California Debra Bach, MSN, RN, CEN, Vermont Stacey M. Cernadas, ADN, RN, EM-T, Alabama Kelly Collins, BSN, Maine Lisa Cooley, BSN, RN, CEN, Virginia Tammy Lalmansingh, BSN, Florida Lisa Lietzke, BSN, RN, CPEN, Delaware Stacy L. Maitha, RN, Indiana Emilie Moore, RN, CEN, Ohio Tina Moseley, BSN, RN, Georgia Kara Moyer, BSN, RN, CEN, Indiana Melissa Myers, RN, CEN, Florida Miranda Newberry, BSN, RN, CEN, Indiana
Curtis Olson, BSN, BS, RN, EMT-P, CEN, Nebraska Mary Pargin, BSN, RN, CEN, Illinois Shannon Mays Smith, BSN, RN, CEN, CPEN, Florida Kathryn Taylor, RN, Texas Deborah Villars, RN, Indiana Katie Wade, BSN, RN, CPEN, Delaware
•ENA Staff Sponsored Foundation Annual Conference Scholarships – $500 each
John Becklehimer, RN, Louisiana Katherine Mason, BSN, North Carolina
Research Grant Recipients•ENA Foundation/Sigma Theta Tau International Research Grant – $6,000
Allison Jones, RN, Kentucky
RESEARCH GRANT OPPORTUNITIES
Applications due Oct. 1 for
•ENAFoundation/ANIAResearch Grant – $6,000• IndustrySupportedResearchGrant – Supported by Stryker – $5,000
Applications due Nov. 1 for
•ENAFoundationSeedGrants – $500 each
Applications are available at www.enafoundation.org.
October 201430
T he state of nursing education in
the mid-20th century was quite
different from what it is today. Diploma nursing programs
thrived and were readily available to the emerging high
school graduate seeking a career path in a world of limited
opportunities for young women.1
Students most commonly chose hospital-based diploma
programs offering guaranteed clinical spaces for those
accepted into the program, unlike the ADN and BSN
models.3,5 During a demanding three-year program focused on
the art and science of nursing, students participated in
rigorous coursework in conjunction with ongoing clinical
assignments in a variety of clinical settings with diverse patient
populations and practice areas. Hospital-based diploma
programs, although limited in liberal arts content, provided a
well-rounded education for emerging professionals seeking a
nursing degree and supplied hospitals with needed staff.1,3
Under the strict guidance of nursing faculty and instructors,
students were assigned a variety of clinical roles and advanced
toward assuming independent responsibility for patient-
centered care upon graduation.
During the next few decades, these dedicated bedside
nurses gained further knowledge and experience and honed
their skills while on the job. Those who showed leadership
capabilities were identified by their superiors and offered job
advancement opportunities at their current educational level.
Seeking an advanced degree may not have been thought
necessary unless one desired to move into formal
management or a teaching position. Returning to school was
certainly challenging while balancing both work and family
obligations.
Today, advancements in medical technology, complex
clinical presentations and disease management require
nurses to achieve higher degrees of theoretical knowledge,
and thus diploma nursing programs have been phased out
while newer models emerged.1,3,4 From 1980 to 2008, the
number of new diploma graduates dropped significantly.3
While all might not agree, despite the decline of diploma
programs, some studies suggest that diploma graduates are
as competent in leadership and critical-thinking skills gained
from on-the-job experience as graduates from other
undergraduate nursing programs, and remain a valuable
asset to the nursing profession.2
Students are now strongly advised to enter the nursing
profession at higher levels to appropriately educate the
workforce of the future.4 Advancement through bridging
programs, incentives and online opportunities ease the
process, yet returning to school is still challenging, requiring
both financial investment and time commitment.
How does education differ from experience? The
separation between the two is the source of knowledge.
Education is attaining knowledge and theory through
textbooks. Experience is based on attaining knowledge and
theory and developing proficient skills over time.7 It seems
that education and experience are not mutually exclusive but
go hand-in-hand in charting one’s personal course and
career path. Novice to Expert — the model developed by
Patricia Benner, PhD, RN, FAAN — theorizes that expert
nurses develop skills and understanding of patient care over
time through a sound educational base as well as a
multitude of experiences.8
The current nursing workforce is comprised of a high
proportion of nurses who are nearing the end of their careers,
as well as those who are just entering the profession.3 The
mean age of nursing’s current workforce is estimated to be
well over 45, and as the baby boomers make their exit,
nursing will be faced with a void of thousands of practicing
professionals in the years ahead.3 There exists a tremendous
interest in nursing as a career, yet nursing schools are unable
to handle the volume of applicants.4 How will we fill these
vacancies and promote funding for faculty and programs
needed to educate our workforce of the future?
Future of Nursing Calls for Both Education and Experience
BOARD WRITES | Ellen (Ellie) H. Encapera, RN, CEN
Official Magazine of the Emergency Nurses Association 31
Updated Teaching
Strategies June 2014
Fourth Edition
The Emergency Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
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In response to the Patient
Protection and Affordable Care Act of
2010, the Robert Wood Johnson
Foundation released a comprehensive
report, ‘‘The Initiative on the Future of
Nursing,’’ and a vision for how nursing
will play a critical role in health care.
Recommendations include the removal
of scope-of-practice barriers,
expanding opportunities for nurses to
lead and collaborate in improvement
efforts, higher degrees of nursing
education at entry levels and beyond,
enabling nurses to lead change to
advance health, implementing
transition-to-practice programs,
promoting lifelong learning and the
collection of workforce data and
research.9 Encompassing all these
initiatives, nursing is perfectly poised
to assume a commanding role in the
future of preventive health care,
coordination of care and providing
comfort when cures are not possible.6
We all face personal challenges
along life’s journey, and sometimes we
must make tough choices. At our core,
we are all registered nurses, possessing
unique talents, skills, education and
experiences. As a diverse mixture of
both educated and experienced nurses,
we all can contribute to an exciting
future of opportunities for nursing.
Respecting our differences and
embracing our commonalities is a
recipe for success in meeting the
challenges ahead.
References
1. Scheckel, M. (2009). Nursing education: Past,
present, future. In G. Roux & J. Halstead (Eds.),
Issues and trends in nursing: Essential knowledge
for today and tomorrow (pp. 27-61). Sudbury, MA:
Jones and Bartlett Publishers, LLC.
2. Clinton, M., Murrells, T., & Robinson, S. (2005).
Assessing competency in nursing: A comparison
of nurses prepared through degree and diploma
programs. Journal of Clinical Nursing, 14(1),
82-94.
3. Committee on the Robert Wood Johnson
Foundation Initiative on the Future of Nursing,
Institute of Medicine. (2011). The future of
nursing: Leading change, advancing health.
Washington, DC: National Academies Press.
4. Aiken, L. H. (2011). Nursing education policy
priorities. In Committee on the Robert Wood
Johnson Foundation Initiative on the Future of
Nursing, Institute of Medicine (Eds.), The future of
nursing: Leading change, advancing health (pp.
6-15). Washington, DC: National Academies Press.
5. Undergraduate nursing education. In Committee
on the Robert Wood Johnson Foundation Initiative
on the Future of Nursing, Institute of Medicine
(Eds.), The future of nursing: Leading change,
advancing health (pp. 369-374). Washington, DC:
National Academies Press.
6. Key messages of the report. (2011). In
Committee on the Robert Wood Johnson
Foundation Initiative on the Future of Nursing,
Institute of Medicine (Eds.), The future of nursing:
Leading change, advancing health (pp. 21-46).
Washington, DC: National Academies Press.
7. Difference between education and experience.
(2011). Retrieved from http://www.
differencebetween.net/miscellaneous/difference-
between-education-and-experience/
8. Benner, Patricia E. (2013). From novice to
expert. Retrieved from http://currentnursing.com/
nursing_theory/Patricia_Benner_From_Novice_to_
Expert.html
9. Robert Wood Johnson Foundation. (n.d.). IOM
recommendations. Retrieved from http://www.
thefutureofnursing.org/recommendations
October 201432
Have you heard a good
story lately? A good
story is one that you don’t quickly forget. Stories are
powerful because they show us rather than tell us
about the human condition. Since the beginning of
time, the best of our values have been passed from
one generation to another, often through stories.
Stories provide us with roots to our past. They are
narratives of life that teach us valuable lessons.
At one point in time, tribes gathered around
central campfires to teach these lessons that helped
provide the group with strength and wisdom.
Because they are narratives of life, they encompass
virtually every facet of human behavior. Stories
weave threads of human interaction into our
everyday life and can infuse into our workplace
respect for our work and our peers.
Storytelling has gained great value in the field of
nursing. The stories told by nurses in the form of
case studies translate in our mind the essential role
of healing of body and spirit that nurses play each
day. The work of nursing theorist Patricia Benner1
used storytelling as the basis for a professional
development model. She applies this process to
demonstrate distinctions in the levels of practice for nurses.
These distinctions allow us to understand the relationship
between practice levels and skills in the individual nurse so
that professional development can be focused and move
forward.
Emergency nursing is practiced in a real world with real
constraints, possibilities and concerns. It is within this type of
setting that excellence can thrive and individual professional
practice can grow stronger over time. When any individual
nurse fails to understand the possibilities and potentials that
are present in practice, the profession as a whole suffers. This
brief excerpt of a developing professional in an emergency
department illustrates the approach to clinical judgment used
for her patient, who presented with a non-urgent complaint
one evening:
My patient certainly was not the most complex care I have
ever given, but it illustrated for me the mental work that needs
to go into my practice each and every day. The habit of
nursing observation is one of the most essential things I do
with my patients, and since
I am with that patient more
than any other member of
the team, my observation
may be key to safe and
appropriate treatment.
What I observed and the
conclusion that I drew from
those observations was
essential in defining a very
different course of treatment
than what was anticipated.
I always tell new nurses
coming to the emergency
department to be vigilant,
look for all clues and decide
what those clues may mean
for this patient.
The nurse who wrote
this narrative asked to not
include her name. She
stated that her reason to
remain nameless was to
convey the message that everyone has stories to tell that can
benefit others.
Narrative accounts such as these reveal an aspect of the
nursing role that is never captured in the formal procedures,
skill lists and job descriptions. Expert nurses often use
phrases such as ‘‘gut feeling’’ or ‘‘something just didn’t feel
right.’’ Watching for subtle changes or recognizing those
early-warning signs are a part of the everyday practice for
emergency nurses.
It has been said that storytelling can teach many lessons
as well as have a profound effect on recuperative and
restorative powers. Stories of emergency nurses will be
presented from time to time so that the essential threads
provided by nurses can be woven into the fabric of
emergency care. The new edition of CATN (Course in
Advanced Trauma Nursing) is based on case-study stories in
advanced trauma.
Reference
1. Benner, P. (2001). From novice to expert: Excellence and power in clinical
nursing practice, commemorative edition. New York, N.Y: Prentice-Hall.
The Wisdom in StoriesPRACTICE
By Kathy Szumanski, MSN, RN, NE-BC, Deputy Executive Director, Nursing
CPR CAN ALWAYS GET BETTER.CPR quality has room for improvement. Fortunately, it can be enhanced to help trained providers optimize CPR performance, according to the recent American Heart Association Consensus Recommendations, “CPR Quality: Improving Cardiac Resuscitation Outcomes Both Inside and Outside the Hospital.”
Download the AHA Consensus Statement to get the tools you need to improve CPR performance.
Visit www.physio-control.com/CPRQuality to get the report.
Morrison L, Neumar R, Zimmerman J, et al. Strategies for improving survival after in-hospital cardiac arrest in the United States: 2013 consensus recommendations: A consensus statement from the American Heart Association. Circulation. 2013;127:1538–1563.
Meaney P, Bobrow B, Mancini M, et al. CPR quality: improving cardiac resuscitation outcomes both inside and outside the hospital. Circulation. 2013;128:1–19.
©2014 Physio-Control, Inc. GDR 3319298_A
HOW GOOD IS YOURDEPTH PERCEPTION?
33% OF CHEST COMPRESSIONS ARE TOO SHALLOW.
October 201434
ELECTIONS
Your vote would never swing an
ENA election, right?
If that thought has kept you from
participating during election season,
when only 5 to 7 percent of ENA
members have voted in recent years,
then here’s a number you might want
to consider: Seven. That’s how many
times in the last 11 elections
that an ENA position has been
decided by fewer than 30 votes.
One contest for president-elect
in that span was decided by 18
votes, another by 11. A race for
a director position was decided
by a single vote in 2004.
We’re not just talking close,
said Nominations Committee
member Terry Foster, MSN, RN,
CCRN, CEN, CPEN, FAEN.
“Very, very, very close,”
Foster said.
Driven by this spring’s 6.17
percent voter participation rate
(just under last year’s 6.36 and
not atypical for professional association
elections) and the idea that races
affecting ENA’s direction could easily
go a different way with more voters
involved, Foster looked online for
inspiration. What he found was ‘‘The
Power of One,’’ a variation of an article
celebrating the importance of
democratic voting and citing historical
examples of a single vote affecting an
outcome. That document
(tinyurl.com/
powerofonevote, QR
code at left) has since
become a rallying point for the
Nominations Committee against two
constant questions: How do we get
more ENA members voting? How do
we get them more engaged?
One barrier is obvious.
‘‘There’s often a similar group of
people voting, and I think one of the
big things is people say, ‘We don’t
know who we’re voting for,’ ’’ said
committee member Lucinda Rossoll,
MSN, RN, CEN, CPEN, CCRN.
Wiping out that concern has
become a top priority. Rossoll sees
continued value in the
candidate forums held and
recorded at ENA conferences
(attending one years ago is
what first convinced her to
vote) and in the traditional
candidate biographies
published each spring in ENA
Connection and on the ENA
website. She and Foster agree
that giving candidates more
questions to flesh out their
positions on issues would be a
step forward.
‘‘Tell me how you feel about
mandatory overtime,’’ Foster
said. ‘‘Tell me how you feel
about unions for nurses. Tell me how
you feel about unlicensed personnel in
the emergency department doing some
nursing duties. Tell me some of those
things — like five questions. I think
that would be great. Then you can say,
‘Oh, no, I don’t like what they’ve said
on that,’ or you can say, ‘I really like
what this person said.’ You have a
much better idea, and that’s the power
of one vote.’’
Rossoll envisions ENA state councils
and chapters — themselves no
strangers to close elections —
becoming major difference-makers.
This goes further than simply reminding
members to vote. New Jersey ENA has
posted the national candidates’ pictures
and position statements on the walls for
reference at election time, Rossoll said.
New Hampshire, her home state, once
had a computer set up at its monthly
meeting and encouraged members to
sign in and vote right there.
Challenging states and chapters to have
spirited conversations about national
candidates could get many more
members invested.
‘‘They could have their own little
forum there,’’ Rossoll said.
ENA members already can ask
candidates questions on a dedicated
Facebook page during election season.
Rossoll said another idea would be to
separately record candidates answering
a list of identical questions and then
share those videos for viewing at state
and chapter meetings.
‘‘I think that would be interesting to
compare the answers,’’ Rossoll said,
‘‘and [one candidate] wouldn’t know
what the other [candidate] had said. I’d
like to have it done in front of a group,
too, just to see how composed they
can be.’’
As the Nominations Committee
explores these and other ways of
enhancing the process, there’s one
certainty: Voting has never been more
important. These efforts are crucial.
‘‘I’ve been a nurse for 37 years,’’
Foster said. ‘‘I have never seen it be so
crazy in healthcare as it has been in the
past two or three years — I mean, just
crazy. Every day you work, there’s
something different, there’s a new
directive, there’s something that’s
changed. Now, more than ever, I think
nurses need their professional
association to represent them. Because
of that, you need to vote to make sure
our association is going in the direction
that the majority wants it to.’’
INSIDE THE MARGINSNumbers Say Game-Changing Votes Are Out There For ENA RacesBy Josh Gaby, ENA Connection
Terry Foster
Lucinda Rossoll
Official Magazine of the Emergency Nurses Association 35
If you were to poll a small group of
your colleagues, there is a high
probability that at some point in their
career, most have gotten a new job
through the power of networking.
An April 2013 LinkedIn article
indicates networking as the top source of hire, according to
data obtained from a source-of-hire survey conducted by
best-selling author Lou Adler.
The process of building and maintaining a solid
professional network has multiple benefits. Professional
contacts can be a valuable source of information such as
benchmarking, the sharing of best practices, information on
new career opportunities and an established social network.
Building a professional network does require time and
effort, but it doesn’t have to be a burden. Capitalize on all the
different ways to make and maintain your connections. In
today’s technology-driven world, there are many ways to
build your network without leaving the house. Participate on
a listserv or discussion forum or touch base with contacts via
e-mail. Be sure to supplement the technology-driven
networking with good, old-fashioned personal connections:
Call an old colleague to catch up, attend a professional
networking meeting or have lunch with some current
colleagues.
As your professional organization, ENA is committed to
helping you accomplish your professional goals and build
your professional network. For more resources
and information, visit the career wellness page at
tinyurl.com/ENAwellness (QR code at left) or
e-mail [email protected].
Let’s Do Lunch: Networking Matters
FUTURE OF YOUR NURSING | Bridget Walsh, PHR, Chief Talent Officer
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October 201436
QUALITY AND SAFETY
F or older adults living in
long-term-care, assisted and
independent living facilities, the
transition of care to the
emergency department is
fragmented. Healthcare facilities
and EDs traditionally operate
independently. Thus, the sharing
of information is inconsistent or
missed.
The significant variability in the
amount of information sent with
patients from these types of senior
residences became apparent in
July 2010 when St. Mary Mercy
Livonia Hospital opened
Michigan’s first senior emergency
center for patients age 65 and
older. As exciting as it was to have
this specialized facility for this
population, what wasn’t anticipated was
the disconnect between each patient’s
current chart information and the key
transfer elements, such as reason for
transfer, code status, medical/surgical
history, medication profile and baseline
cognitive and functional status
necessary for emergency decision,
diagnosis and disposition.
Unavailable data when transferring
patients resulted in unnecessary rework,
inefficiencies and emergency healthcare
providers working blindly. Moreover,
incomplete information predisposes the
patient to receive unwanted or less care,
unnecessary tests and even wrongful
resuscitation in some cases.
According to Terrell et al.,
incomplete patient data contributes to a
flawed care plan, safety issues (such as
medication errors) and rehospitalization.
Moreover, flawed executed care
transitions can further lead to overuse of
emergency services and subsequent
unnecessary hospital admissions, thus
increasing healthcare costs.
A smooth patient flow is critical for
ED patients. Any lack of communication
interrupts care as ED staff time and
energy is diverted from primary
responsibilities to calling facilities to
obtain clinical information to treat
transferred patients in a competent
manner. Healthcare professionals are
then removed from the ED patient’s
side, which adds minutes to turnaround
time, affecting throughput and
contributing to ED overcrowding and
eventually patient and staff
dissatisfaction. Overall, instances of
omissions can increase the
possibility of adverse events
associated with long ED wait
times, thereby compromising
quality and safe delivery of
care.
Identifying the ProblemThe ED team (nurses,
physicians, techs, clerks, senior
social worker and case
manager) at St. Mary Mercy
Livonia recognized that efforts
to address these failures would
require systems-based changes
to improve patient safety
during transitions of care in
both directions. ENA’s
‘‘Practical Guide to Safer
Handoff of Older Adult
Patients Between Long-Term
Care Facilities and the ED’’ was
used as a guide to help facilitate the
first meeting. The guide has been
replaced by the new Geriatric
Emergency Nursing Education product,
which can be accessed at
tinyurl.com/ENA-GENE
or by scanning the QR code
at left.
The team then extended an
invitation to long-term care facilities,
emergency medical services and other
providers of care in the area to partner
in improving the transition process.
The response was outstanding. On
Nov. 14, 2011, they held their first
meeting. The energy in the room was
palpable as each member shared his or
her facility’s capabilities, transfer
documents and protocol. It became
clear how little everyone knew of each
MISSION: TRANSITION
By Joan Michelle Moccia, MSN, ANP-BC, CCRN
Alarmed By Information Gaps During Transfers of Older Adults, Michigan ED Team Starts a Coalition to Change the Local System
Official Magazine of the Emergency Nurses Association 37
Whether you are just starting out or are a seasoned clinician, your ENA membership provides professional and career benefits:
§ FREE Continuing Education courses every month – online § Employment resources and resume tools through ENA’s Career Center § Networking opportunities at local events and annual conference § Grants and scholarships available through the ENA Foundation § Nursing achievement recognition through award opportunities § Toolkits and practice/research documents
Get MOREOut of Your ENA Membership
Visit www.ena.org and take advantage of all the resources your ENA membership has to offer.
Membership Ad_Connection_half_10 2014.2.indd 1 9/1/14 9:56 PM
other’s scope-of-care capabilities and
transport procedures. Without
hesitation, the group agreed to
continue to meet monthly and focus
on improving transitions of care.
A bond was created, and a name
was selected to reflect the mission.
‘‘STARForUM: Safe Transition of All
Residents For yoU & Me’’ was born.
Making ImprovementsThe group has been meeting monthly.
Two-and-a-half years later, this
grassroots organization has been
responsible for many innovations and
interventions, including the following:
• Process-flow mapping of each facility
(skilled, assisted living, independent,
home health care) and EMS response
to a resident’s symptoms requiring
transport to the ED and return
• Color-coded phone directory to help
identify the facility level of care (red =
skilled; yellow = assisted; green =
independent)
• The facility care nursing capability,
i.e., wound care or IV therapy,
hyperlinked to the directory
• Audit tool (members self-monitor the
information sent to the ED by
reviewing the information sent from
the previous month)
• Transition checklist (list of key
elements needed for ED care)
- Medication assessment record
noting time of last dose given
- Recent antibiotic use
- Reason for stay in facility
- Medical/surgical history
- Family notification
- Code status
- Baseline mental and functional
status
- Last known time normal
- Fall patients: Mechanical or
physiological
• Transition letters from independent
facilities detailing services and/or care
plan detailing purchased support
services, i.e., medication reminders,
assist with ADLs
• Universal transfer form
• ED transition envelope/checklist for
safe return of ED patient back to
facility as a resident, followed by an
ED phone call detailing care received
in the ED and response of resident
• Encouragement of facility to send in
picture ID of their resident
• Discharge instructions including size
and manufacturer of peg tube
replacement
• Discharge instructions including
PICC lumen size and manufacturer
• Sepsis cue card to alert caregivers on
SIRS criteria
Continued on page 44
With the 2014 ENA Lantern Award recipients announced
in August, it would seem the members responsible for
the months-long application review process could kick back
and relax. However, the work of the Lantern Award Review
Committee is ongoing as members continually seek to
improve the process, chairperson Tami Morin, MS, RN,
NEA-BC, said.
The Lantern Award is a recognition award given to
emergency departments that exemplify exceptional practice
and innovative performance in the core areas of leadership,
practice, education, advocacy and research.
Morin, director of emergency services
at the University of Wisconsin Hospital,
leads a group of seven members who
review and score applications
submitted annually. The members’ work
begins in January with a conference call
to discuss the committee’s charges and the
award scoring tool and process. The next step is that
members receive sample Lantern Award applications falling
into each of the scoring bands — low, medium and high
— to try their hand at scoring. These results are reviewed
and compared to see how much inter-rater reliability there is
— whether members are scoring consistently or if there are
gaps that need to be addressed. The committee receives
actual applications in early spring.
‘‘That is where the true work begins,’’ Morin said.
For the 2014 cycle, each committee member was assigned
multiple applications. Each application is scored by more
than one person.
‘‘It takes me about three to four hours to score one
application,’’ Morin said. ‘‘When you multiply three to four
hours by 14, it’s a significant time commitment.
‘‘But when you think about how important it is to the
facilities that have applied, you don’t want to rush it. You
want to do a really good job because they’ve invested a
significant amount of time in preparing their application.’’
The committee meets at ENA headquarters in July to
discuss the selected award recipients, review any issues with
the scoring tool and make recommendations for revisions.
This is also when members draft letters to facilities that did
not receive an award.
‘‘I think this year was the year that we spent the most time
in drafting those letters, trying to give very specific feedback
that is useful to the facilities so if they reapplied, they would
really focus their energies in certain areas,’’ Morin said.
After all applicants are notified, the committee has more
homework. Members conduct literature searches on specific
sections within the application to ensure that the latest
literature is cited. A few members also participate in a Q&A
session at the ENA Annual Conference.
For potential applicants who can’t attend the committee’s
session in Indianapolis, Morin shared the following advice:
‘‘Make sure to read the guide provided by ENA on applying
for the Lantern Award. It really has the tips and tricks to
make sure that you are submitting a strong application.’’
Her second piece of advice is to ‘‘really look at your
department and your data and determine when the right time
to apply is. There are facilities who are doing great things,
but when you look at the requests for data showing tracking
and trending and sustained improvements, there has to be a
time frame on the back end of implementation where they
can really demonstrate those improvements.”
October 201438
Lantern Team Always Has a Light On
THE ENA LANTERN AWARD COMMITTEE: Clockwise, from lower left: Catherine Olson, MSN, RN, staff liaison; Sheryl Bloomer, MA, BSN, RN, CPN; Ellen Siciliano, BA, staff liaison; Tobin Miller, MSN, RN, CEN, CCRN, MICN; Jennifer Davis, MSN, MPH, RN, EMT-P, CEN, NE-BC; Tami Morin, MS, RN, NEA-BC, chairperson; India Owens, MSN, RN, CEN, NE-BC, FAEN. Not pictured: JoAnn Lazarus, MSN, RN, CEN, Board of Directors liaison; Kenneth Grubbs, MBA, RN; Jason Moretz, MHA, BSN, RN, CEN, CTRN.
By Amy Carpenter Aquino, ENA Connection
Details Matter.
October 201440
It’s an exclusive group that accepts
only one new member each year. It
takes years to qualify, including one
final whirlwind year of travel,
meetings, speaking engagements and
high-level decision-making, but once
you’ve gained access to this group,
you are guaranteed a spot for life.
The group is the ENA past
presidents, who reached 42 members
this year. When their latest addition,
JoAnn Lazarus, MSN, RN, CEN, the 2013
president, was conferring with past
presidents during the course of her term
last year, she realized the association
was not taking full advantage of their
wealth of leadership experience.
‘‘I recognized as we were moving
into the changes that were happening
within ENA last year, and even before
that, that we really weren’t tapping
into the wisdom and knowledge of our
past presidents,’’ Lazarus said. ‘‘I
wanted to figure out a way to bring a
group together to find out how they
were feeling about their role as past
presidents, and were they being
acknowledged in their role?’’
Lazarus proposed the formation of
the Past Presidents Task Force, which
the Board of Directors approved in
2013. Lazarus appointed Vicki C.
Patrick, MS, APRN, ACNP, CEN, FAEN,
1981-1982 ENA president and
chairperson; Joanne M. Fadale, BSN,
RN, FAEN, 1990 ENA president;
Benjamin E. Marett, EdD, MSN, RN,
CEN, CCRN, FAEN, 2000 ENA
president; Sherri-Lynne Almeida, DrPH,
MSN, MEd, RN, CEN, FAEN, 2002 ENA
president; and Nancy Bonalumi, MS,
RN, CEN, 2006 ENA president. The
same members are on the 2014 Past
Presidents Work Team.
Lazarus said she intentionally chose
past presidents from different decades
to represent varying years of
experience and service to ENA
‘‘because ENA has changed, and with
that, perceptions have changed,’’ she
said. ‘‘As we prepare for the future, we
can’t forget about how we got where
we are, and that’s through a lot of our
traditions and just the knowledge that
a lot of these past presidents have.’’
In a testament to their legacy as high
achievers, the task force immediately
created a survey for past presidents to
gauge their perceptions of their role
since leaving the board. The survey
helped fulfill the task force’s charge,
which Marett said was ‘‘to make
recommendations to the board of what
the expectations, roles and recognition
of past presidents should be.’’
The survey assessed the past
presidents’ opinions on experiences
such as their first year off the board
and resuming the member role, as well
as whether they thought there should
be an orientation to the past president
role and what roles could be identified
for past presidents, Almeida said.
‘‘This is a rich source of
information, not only about what’s
currently going on in the association
but the history of the association,’’ she
said, adding that it would be a shame
to ‘‘lose that knowledge bank.’’
The group received responses from
33 of the 37 living past presidents, an
impressive 85 percent response rate,
and the overall results were positive.
‘‘I think that most of the group felt
that there was a place for them within
ENA, that there were contributions that
they were able to make and willing to
make and that they wanted to be
involved in the association,’’ Bonalumi
Past Presidents: Their Work Continues
THE ENA PAST PRESIDENTS WORK TEAM: From left: Nancy Bonalumi, MS, RN, CEN; Joanne M. Fadale, BSN, RN, FAEN; current ENA president Deena Brecher, MSN, RN, APN, ACNS-BC, CEN, CPEN; Benjamin E. Marett, EdD, MSN, RN, CEN, CCRN, FAEN; chairperson Vicki C. Patrick, MS, APRN, ACNP, CEN, FAEN; and Sherri-Lynne Almeida, DrPH, MSN, MEd, RN, CEN, FAEN. Not pictured: ENA Board of Directors liaison JoAnn Lazarus, MSN, RN, CEN, immediate past president.
By Amy Carpenter Aquino, ENA Connection
Official Magazine of the Emergency Nurses Association 41
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said. ‘‘They felt that while their role
was different, there was still value that
they could bring to the association.’’
Marett said past presidents
expressed interest in varying levels of
ENA involvement, from publishing in
the Journal of Emergency Nursing to
serving as mentors for the Academy of
Emergency Nursing and volunteering
for the ENA Foundation.
Lazarus said the second phase for
the work team is to help prepare ENA
presidents to move into the role of a
past president and to ease a transition
that she compared to ‘‘falling off a cliff.’’
‘‘One minute you’re in the know,
you’ve got all the information, people
are talking to you, and that’s through
Dec. 31,’’ she said. ‘‘And then Jan. 1
— well, now you’re not.’’
Immediate past presidents
experience a ‘‘sudden information
deficit’’ at the end of their term,
Lazarus said, and ‘‘there needs to be
some assistance with that transition.’’
Requesting input from presidents of
different eras ensures that a depth of
experience and collective wisdom will
contribute to creating better transitions
for ENA presidents, Patrick said.
Since ENA has many past presidents
involved at many different levels, there
are ample opportunities to stay active.
The ‘‘transition team,’’ as Patrick
referred to the work team, aims to help
past presidents arrive at how they can
productively make contributions once
they return to the role of the volunteer
rather than the elected official.
‘‘You have to decide what your
level of activity is going to be and how
you can offer to make those
contributions in a constructive manner
for the association,’’ Patrick said.
Fadale said it was surprising to find
in the research that some associations
‘‘put their past presidents out to pasture;
they have no say-so, no activity, no
involvement in their association ever
again, which I feel is very sad. It’s not a
good use of nursing knowledge or
management knowledge.’’
‘‘Or association knowledge,’’ Marett
added.
A literature search revealed that
very little information exists about
transitioning out of an association
leadership role or how to support
people going through that transition,
Bonalumi said.
‘‘I think we’re actually carving out
some new knowledge,’’ she said.
‘‘We’re at least identifying a plan for
our organization that may serve as a
template to others down the road.’’
Lazarus sees the work team
continuing for the foreseeable future
because each Dec. 31 will see a
mentoring opportunity for the newest
past president. Having people who
have been through that experience
will be invaluable. As Almeida said,
‘‘You have to walk in these shoes to
appreciate how difficult it can be to
walk in these shoes.’’
October 201442
Although it’s being sunsetted at the
end of this year, the Emergency
Nursing Technology and Informatics
Work Team has created several
resources that ENA members will be
able to use for years to come,
including some that offer guidance on
how technology can improve
emergency preparedness planning in
the emergency department.
Work team member Jeannette
Jefferies, MS, RN, CCRN, posted a
preliminary article titled ‘‘Preparing for
Disaster – Use of a Patient Tracking
System’’ to the ENA committee shared
documents site, and the complete
paper should soon be available to all
ENA members.
In the paper, Jefferies describes how
using a disaster tracker board can help
ED staff who need to track both disaster
patients who came into the ED and
regular ED patients. The regular ED
patients stay on regular tracker, while
disaster patients could be quickly
assigned to the disaster tracker. Jefferies
shows how to create a quick registration
for disaster patients and includes screen
shots of the quick registration and the
disaster tracker board.
A technology Jefferies has been
exploring is radio frequency
identification, or RFID, which she said
is superior to the more common
barcode scanning technology. While
barcode scanning is simpler and less
expensive, problems can arise with vital
processes such as patient identification;
if the admitting department, for
example, merges records and changes a
patient’s account number that is already
printed on his wristband, someone has
to make sure to switch out the patient’s
wristband. Sometimes a patient can end
up with two wristbands, and the wrong
code can be scanned. Patients also can
become disturbed and remove their
wristbands.
‘‘There are lots of potential risks
when it comes to scanning patients,’’
Jefferies said.
To decrease these and other risks,
some EDs have started using RFID to
track patients and be used for patient
identification. The technology has
been commonly accepted for tracking
equipment, such as monitors and IV
pumps, and even has been used to
track staff, she said. For example, RFID
can tell when a physician enters a
patient’s room to pinpoint exactly
when the medical screening exam
started, Jefferies said.
Her current facility, Mercy Medical
Center in Baltimore, where she works
in nurse informatics, uses a form of
RFID on the inpatient side.
‘‘We have it hooked up to our
call-light system, so when the nurse
walks into the room, it actually turns
Technology For Post-Disaster Tracking
THE EMERGENCY NURSING TECHNOLOGY AND INFORMATICS WORK TEAM: Front row, from left: Dagny S. Scofield, RN, CEN, CPEN; Monica Escalante, MSN, RN, senior associate, IQSIP. Middle row: Jeannette Jefferies, MS, RN, CCRN; Debra Esse, MHA, BS, RN, CEN. Back row: Mitch Jewett, RN, CEN, ENA Board of Directors liaison; David G. Holman, MNSc, RN; Michael Seaver, BA, RN, chairperson; and Leslie Talbert, senior administrative assistant, IQSIP.
By Amy Carpenter Aquino, ENA Connection
Official Magazine of the Emergency Nurses Association 43
MAKE HISTORY WITH ENA!September 28 – October 3, 2015Orlando, Florida
Emergency Nursing 2015 will integrate the leadership and annual conferences into one new and exciting ENA conference experience. Start planning now for Orlando– the perfect destination for you, your colleagues, and your family.
§ Both clinical practice and leadership tracks § Interactive demonstrations of cutting edge technology
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Save the date for this inaugural event!
EN15 Save the Date Ad_Connection_half_10 2014.indd 1 9/1/14 10:02 PM
the call light off,’’ she said.
Another advantage RFID has over
barcode scanning for patient
identification is the inability to avoid
the system, said chairperson Michael
Seaver, BA, RN.
‘‘There was actually an article
published on the top 20 ways to work
around barcoded patient
identification,’’ he said.
Not that workarounds are always
negative.
‘‘Nurses, and emergency nurses in
particular, are notoriously adept at
making things work, whether it’s 101
uses for tape, or how do we avoid
delays due to technology, for which
the processes of the new technology
have not been thought out yet,’’
Seaver said.
Sometimes the workaround
provides a better outcome than the
original process, in which case Seaver
suggested people should keep an
open mind and consider making the
workaround the standard process.
‘‘To come up with a decent
workaround typically means that
someone has put in some good,
creative thinking,’’ he said.
Electronic medical record technology
is also being used more in disaster
preparedness planning. The ability to
create virtual care areas, for example,
can help an ED prepare for what
happens when 27 unexpected patients
are brought in after a train accident.
‘‘It’s one thing to be able to
recognize that this is where we’re
going to put all these people, for
instance,’’ Seaver said. ‘‘You may have
the greatest plan in the world —
walking wounded all going to this area
of the hospital — but then how do
you keep them organized? How do
you keep a head count? If you have
them built into the patient tracking, the
more information you have, the more
easily you can recognize that
information and deal with that
information.’’
Another way in which technology
can help in disaster planning is
syndromic surveillance, which is also
addressed in many electronic medical
record systems. Seaver explained
syndromic surveillance as an ED’s
ability to report on a large influx of a
vague gastrointestinal complaint, for
example.
‘‘Is it just coincidence, or is it maybe
something in the water supply?’’ he
said. Monitoring and reporting such
outbreaks to the Centers for Disease
Control and Prevention or the county
health department can help prevent a
biological hazard from becoming more
widespread.
The work team’s EMR handbook,
which also should be available to ENA
members soon, includes information
on patient identification, building
virtual locations and syndromic
surveillance, among other technology
issues.
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17 Chamberlain College of Nursing www.chamberlain.edu/info/ena.org
47 Fraser Health careers.fraserhealth.ca
27 Gebauer Company www.gebauer.com
46 Health Match BC www.healthmatchbc.org
45 Memorial Hermann ENA.MH-jobs.org
45 Munson Healthcare munsonhealthcare.org/recruitment
7 N-Pak www.n-pak.com
47 Nielsen Healthcare www.nielsenhealthcare.com
33 Physio-Control Inc. www.physio-control.com
29 Pinpoint Limited www.pinpointlimited.com
39 Stryker www.stryker.com
15 Teleflex Incorporated www.teleflex.com
18- Teva Pharmaceuticals22 www.tevausa.com
45 Tucson Medical Center tmcaz.com/NursingJobs
47 University of Texas Southwestern jobs.UTSouthwestern.edu
ADVERTISER INDEX
October 201444
• “Plan in a Can” (tennis ball can
innovation) and “Just in Case”
emergency brochure to secure vital
health information,
www.mymercy.us/justincase
• ‘‘Transitions of Care: The Perfect
Storm,’’ a live show consisting of
one-act vignettes showcasing excellent
and poor transitions of care; the show
was recently presented to the Wayne
State University Institute of Gerontology
• A website (in creation) to share
STARForUM’s tools
Reinforced by DataA retrospective quality assurance
review held between Nov. 19, 2013,
and Feb. 14, 2014 (n = 123)
demonstrated that those onboard with
the mission of STARForUM were much
more likely to send in key elements on
a 15-point transfer of information scale
than those who were not invested.
STARForUM members soon will be
testing the response of information
received by using a checklist delivered
by EMS personnel to facility staff when
they arrive to transport their resident
to the ED. Checklists can provide
guidance to paramedics and facility
staff and act as verification following
documentation of the identified key
clinical elements for a safe transition.
Checklists serve to aid in memory
recall, standardization and regulation
of processes, providing an outline for
evaluations or as a diagnostic tool.
ConclusionsThe success of the STARForUM group
is due to the unwavering devotion of
each individual to ensure the safe
transition of the vulnerable older adult.
An opportunity exists for every ED
in the nation to engage and strengthen
relationships with providers involved
in transition of care from nursing
facilities (skilled, assisted and
independent), EMS (interim providers
of care), licensed and nonlicensed
home care personnel, social workers,
case managers and ED personnel.
We hold our patients’ hearts in our
hands. Use your passion, wisdom and
advocacy to help remove barriers and
improve care quality and safety to this
vulnerable subset of older adult patients
through a coordinated care transition
approach that also will impact 30-day
readmissions. Let’s cross this healthcare
quality chasm together.
References
Coleman, E. A., Smith, J. D., Frank, J. C., Min, S., Parry, C., & Kramer, A. M. (2004). Preparing patients and caregivers to participate in care delivered across settings: The care transitions intervention. Journal of the American Geriatrics Society, 52, 1817-1825.
Hales, B. M., & Pronovost, P. J. (2006). The checklist—A tool for error management and performance improvement. Journal of Critical Care, 21, 231-235.
Terrell, K. M., & Miller, D. K. (2006). Challenges in transitional care between nursing homes and emergency departments. Journal of the American Medical Directors Association, 7, 499-505.
Resources
Improving on Transitions of Care: How to Implement and Evaluate a Plan, www.ntocc.org
Better Outcomes by Optimizing Safe Transitions (BOOST), www.hospitalmedicine.org/BOOST
Project RED (Re-Engineered Discharge), www.bu.edu/fammed/projectred
INTERACT (Interventions to Reduce Acute Care Transfers), interact2.net/
Remington Report (Interventional strategies and programs to improve care transitions with supporting evidence), www.remingtonreport.com
Transitions of Care Continued from page 37
Go the distance at Memorial Hermann.
Choose from locations throughout Houston:• Children’s Memorial
Hermann Hospital• Katy• Memorial City • Northeast • Northwest (Inner Loop)• Pearland (Opening soon –
now hiring ER)• Southeast • Southwest • Sugar Land • Texas Medical Center • The Woodlands
EOE, M/F/D/V. No agencies, please.
Memorial Hermann is a world-class health system with locations throughout Houston and the surrounding areas. With benefits eligibility that begins the first day of employment, this is a great time to become part of our award-winning organization. Our team of more than 20,000 consistently votes us among Houston’s Best Places to Work. Find out why—and take your career to a higher level.
Search current job openings at ENA.MH-jobs.org
CONTACT US
Toll-free1-866-441-4567
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Great ER nursing careers – visit us at Booth #354 at the
ENA Conference to find out more!
memorialhermanncareers @MHTalent
5301 East Grant Road, Tucson, Arizona 85712 EOE Tobacco-free workplace
DREAM JOB.
When you choose a place to work… CHOOSE WELL.
Enjoy Tucson’s wonderful weather and grow your career in an environment that is fun, challenging and rewarding.
Check out all available positions at tmcaz.com/NursingJobs
NOW SEEKING ED, CRITICAL CARE AND ICU NURSES SIGN ON BONUS AVAILABLE!
Love what you do, and where you do it.Check us out. Be inspired.
munsonhealthcare.org/recruitment
Official Magazine of the Emergency Nurses Association 45
The Island The North
JOB #H104-16165CLIENT: HEALTH MATCH BC
PUBLICATION: EMERGENCY NURSES ASSOCIATION ADINSERTION DATE: OCTOBER ISSUE
TRIM SIZE: 8.125" X 10.875"PREPARED BY: ECLIPSE CREATIVE INC. @ 250-382-1103
Fraser Valley
Discover the perfect place to call home.
Enrich your career. Enhance your quality of life.Join the many emergency nurses who have moved to British Columbia (BC), Canada to enjoy a quality of life that is envied around the world. Find out how our nurse services team can assist you in matching your lifestyle interests with exciting career opportunities. Register online today!
TOLL-FREE: 1.877.867.3061 • TEL: 1.604.736.5920 • EMAIL: [email protected] Photo Credit: Picture BC
healthmatchbc.orgHealth Match BC is a free health professional recruitment service funded by the Government of British Columbia, Canada
FIND A JOB IN BC
Emergency Nurses Association
Annual Conference, Booth 650
October 9-11, 2014
Indianapolis, IN
Meet with our team
16165 Emergency Nurses Ass'n Ad Oct.indd 1 Minguo 103-08-27 9:18 AM
Official Magazine of the Emergency Nurses Association 47
Emergency Nurses ~ Meet us at the ENA Conference - Booth #438
Together, we create great workplaces.
Apply online: careers.fraserhealth.caToll-Free: 1-866-837-7099Facebook: /fraserhealthcareersTwitter: @FHcareer
New Challenges, Rewards & Breathtaking Scenery!
In late 2014, the William P. Clements Jr. University Hospital will open its doors at UT Southwestern Medical Center, transforming medical care in North Texas and serving as a model for academic medical centers across the country. Join us now and get in on the ground floor as we build the future of nursing, today.
Join our busy and growing Emergency Department, a 30-bed unit seeing 36,000 patient visits a year and the only Joint Commission Accredited Comprehensive Stroke Center in North Texas.
Assistant Nurse Managers Emergency Department
Requires BSN, BLS, ACLS and 3-5 years current RN experience, of which at least 2 years have recently
been spent in an ED. Leadership experience as a charge nurse, coordinator or team leader is a plus!
Apply online at: jobs.UTSouthwestern.edu Or email [email protected]
All we need is you.
Explore opportunities as we buildthe team to open our new hospital!
UT Southwestern is an Affirmative Action/Equal Opportunity Employer.
Dallas, Texas
We are the future of nursing, today.
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Improve emergency care, improve your career
You know us as recognized ED leaders who guide hospitals toward real and
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— B I L L B R I G G S , M S N , R N , C E N , F A E N
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13BJAC_ENA_RecruitmentAd 0807.indd 1 8/8/13 1:40 PM