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August 2014 Volume 38, Issue 7
the Official Magazine of the Emergency Nurses Association
connectionCOMMON LANGUAGE
ENA’s Influence Spreads With a Seventh-Edition TNCC Dissemination in Abu Dhabi
PAGES 14-17
PLUS . . .♦ ENA Election Results 6
♦ Member’s Video Geared to Stop ‘Hill Hopping’ 10
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
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Workplace Violent Prevention Ad_Connection_Full_08 2014_print.pdf 1 7/9/2014 3:33:02 PM
3
At-Risk Behaviors Can Lead to Errors
FROM THE PRESIDENT | Deena Brecher, MSN, RN, APN, ACNS-BC, CEN, CPENDates to Remember
PAGE 4Free CE of the Month Members in Motion
PAGE 26ENA Foundation
PAGE 28Academy of Emergency Nursing
PAGE 34Board Writes
Regular Features
Oct. 5-11, 2014 Emergency Nurses Week (Emergency Nurses Day is Oct. 8)
Oct. 7-11, 2014 ENA 2014 Annual Conference, Indianapolis
PAGE 62014 ENA Election Results
PAGE 9ENA Can Approve CNE Into 2018
PAGE 10Oregon Member to Be Honored For Video Against ‘Hill Hopping’
PAGE 14 Worlds Come Together During TNCC Dissemination in Abu Dhabi
PAGE 18Ramping Up Pedestrian Safety
PAGE 25CODE YOU: How Strong Is Your Emotional Intelligence?
PAGE 30The Ethics of Nursing for Your Family
PAGE 32Legislators Listening After ENA’s Record Day on the Hill
PAGE 36Flu Vaccinations: Best Shot at Safety
PAGE 38Work Team Tackles ED Technology
PAGE 40ENA Archives: The Roadrunner
PAGE 42Faster Care With Video Interpretation
ENA Exclusives It’s halfway through your shift and you finally feel caught up. You
offer to help your teammate give a dose of morphine to a patient
with a left lower-leg deformity. You checked the order, removed
the medication from the medication dispensing cabinet and went to the patient’s bedside.
While you were able to scan the patient’s barcode ID band, you were unable to scan the
medication. After a few unsuccessful attempts, you just gave the medication to the patient.
In an effort to report the difficulty, you share your frustration with the charge nurse, who
validates that, yes, there is an issue with the morphine currently stocked and it does not
scan. She assures you
that everyone is not
scanning the medication
since the scan doesn’t
work and not to worry
about it. You go back to
your patient assignment.
You are walking
down the hallway and
you hear a pulse
oximeter alarm sounding.
The patient is not on
your team, but you stop,
reposition the patient and
walk away, getting back
to your mission at hand.
A co-worker calls you
to a computer to sign off
on a dose of insulin. The
dose already has been
administered. You have
worked with this person
for years and trust her
with your life. You sign
off the insulin.
All of your patients
are tucked in and stable. It’s a good time to go and grab lunch. You find your teammate in
the medication room, pulling medication for procedural sedation. You poke your head in
and say, ‘‘My patients are fine — I’m going to grab lunch. I’ll be back in 15 minutes.’’ He
nods, and you leave the unit.
In the ED, we are in a constant state of busy. Distractions, interruptions, volume,
crowding and pressure to decrease length of stay, increase patient satisfaction and provide
safe and timely care can drive our behavior in the ED. There are times we engage in at-risk
behavior.
In the first example, working around the system issue and not following the proper
reporting channels has the potential to lead to an error. In the second example, the patient’s
Official Magazine of the Emergency Nurses Association
Continued on page 8
Boost your CE credits this summer by
learning more about two important topics
— veterans with PTSD and how the
Affordable Care Act is affecting you — in
the latest free continuing education
sessions from ENA.
Available as of July 1 . . .‘‘Wounded Warriors: PTSD
and Suicide in Returning
Veterans,’’ presented by
Cheryl Randolph, MSN, RN,
CCRN, CEN, CPEN, FPN-BC.
(Credit: 0.87 contact hours.)
Randolph leads a review of the psychology in warfare that can lead to
post-traumatic stress disorder and suicidal intent. Learn to recognize
PTSD and suicidal intent in veterans coming through your ED and
familiarize yourself with available treatments and therapies.
Available beginning Aug. 1 . . .‘‘What’s Happening in Washington That Affects EDs,’’ presented by
Richard Mereu, JD, MBA. (Credit: 1.0 contact hour.)
This session explores the implementation of the Affordable Care Act,
including Medicaid expansion, state health care exchanges and
coverage for young adults. Mereu outlines the budget situation in
Washington and its impact on key programs and other legislation that
could impact emergency nurses.
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 ‘‘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 later, go to www.ena.org and find ‘‘Go to Personal
Learning Page’’ under the Education tab.
Please 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 is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
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, 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
Sizing Up ATV Safety in ArkansasArkansas ENA recognized ATV Safety Month in April by
putting on an education event at a minor-league baseball
game in Springfield, Ark., in partnership with the Northwest
Arkansas Trauma Regional
Advisory Council and
Fayetteville Kawasaki. More
than 1,200 people attended.
Children between ages 8 and 18
— the key target group —
received free fitted helmets in
exchange for participation in a
survey on helmet safety. State
council members distributed
brochures and shared ATV
safety tips.
New Jersey Recognizes Its OwnNew Jersey ENA announces the following winners from its
annual Emergency Care Conference:
• Innovations in Nursing Education: Mary Kamienski,
PhD, APRN-C, CEN, FAEN, FAAN
• Spirit Award: Bill Miller, BS, RN, PHRN, NREMT-P
• Advanced Practice Award: Gwyn Parris-Atwell, MSN,
RN, NP-C, CEN, FAEN
• Behind the Scenes Award: Karen Halupke, MEd, BSN, RN
• Nursing Education Award: Ray Bennett, BSN, RN, CEN,
CFRN, CTRN, NREMT-P
• Rising Star Award: Sean Varricchio, MSN, RN, CEN, CPEN
• Quality and Safety Award: New Jersey Hospital
Association, Institute for Quality and Patient Safety
• President’s Award: Pat Nierstedt, MS, RN, CEN
• President’s Award: Beth McFarland, RN, CEN
Official Magazine of the Emergency Nurses Association 5
It’s OK with us if you study at the beach or in a lawn chair.Board of Certification for Emergency Nursing (BCEN®) certifications demonstrate your commitment to excellence in nursing care and professional advancement.
You have the confidence and expertise, now make the decision to join the 35,000+ emergency nurses who have earned their mark of distinction!
Learn more… www.BCENcertifications.org
It’s summer. Take a breath. Earn your certification.
A team led by front-line staff at the
Fairview Ridges Emergency
Department in Burnsville, Minn.,
received the 2014 Innovation of the
Year (Patient Care) Award from the
Minnesota Hospital Association.
Because of a series of staff-owned
initiatives, including best-practice
research and visits to other EDs,
Fairview Ridges implemented an “open
rooming” system for physicians that
eliminated assigned exam rooms and
later a “pull until full” system of
bringing patients directly to ED rooms,
bypassing a stop at triage. This resulted
in an average time of 17 minutes from
patient arrival to physician examination
in 2013, down from 37 minutes in 2012
and 54 minutes in 2011.
ED Staff Among Top Innovators in Minnesota
From left (front row): Shawnda Braun, RN, CEN; Anne Sherman, MS, ACNS-BC,
CEN**; co-leader Peggy Heppner, MA, RN, CEN, CPEN**; Becky Daily, RN; (back row)
ED director Jamie Hornibrook**; John Houghland, MD, FAAEM; Tammy Digirolamo,
RN, CEN; co-leader Tanda Tavakley, RN; Jessica Bents, RN**; and Mike Rock, MD,
FACEP, FAAEM.
** Denotes ENA member Do you have a recent professional or educational success story about yourself or an ENA member colleague? E-mail it to ‘‘Members in Motion’’ at [email protected].
ENA is pleased to announce the results of the 2014
election for the ENA Board of Directors and the
Nominations Committee. Voting concluded June 11.
Voter participation was down slightly from 2013, with 6.17
percent of 41,161 eligible members casting votes. The
Vermont ENA State Council had the highest voter turnout at
13.07 percent participation, followed by the North Dakota
ENA State Council with 12.24 percent. Other state councils
with double-digit voter turnouts were Nebraska and Utah.
Members can view the official election results in the
members-only section of www.ena.org.
ENA commends all of the candidates for their involvement
in the 2014 election, as well as all of the members who
voted.
The official installation of the 2015 board and committee
members will be held Oct. 8 at the JW Marriott Indianapolis
during the 2014 General Assembly. Newly elected members
of the ENA Board of Directors will take office Jan. 1, 2015.
Nominations Committee members will begin their terms in
October.
6 August 2014
Board Officers2015 President-Elect
Members elected
Kathleen E.
Carlson, MSN,
RN, CEN, FAEN,
as the 2015
president-elect.
Carlson is an ED
staff nurse at
Sentara Virginia
Beach General
Hospital in Virginia Beach, Va.
Carlson is the 2014 secretary/
treasurer of the ENA Board of Directors
and has been a board member since
2011. She is a 2008 recipient of the
Judith C. Kelleher Award and was
inducted into the Academy of
Emergency Nursing in 2009. She has
contributed to several ENA projects,
including serving as co-editor of the
Emergency Nursing Certification
Review and as a longtime contributing
editor of the Journal of Emergency
Nursing. She is a past president of the
Connecticut ENA State Council.
‘‘I am so humbled,’’ said Carlson, an
ENA member since 1976. ‘‘ENA has
become my second family.
‘‘This was a close election with
another very capable candidate. I am
honored and will continue to listen,
weigh all options, be objective and
make decisions based on what is best
for our organization. I will keep you
informed and look forward to hearing
your ideas and concerns.’’
2015 Secretary/Treasurer
Members elected
Karen K. Wiley,
MSN, RN, CEN, as
the 2015 secretary/
treasurer. Wiley
is an ED staff
nurse at Alegent
Creighton
Immanuel Medical
Center in Omaha, Neb.
This is Wiley’s third year as a
member of the ENA Board of
Directors. She was president of the
Nebraska ENA State Council in 2001
and 2010 and served as the Nebraska
ENA Government Affairs chairperson
from 2000 to 2013. Wiley has been a
passionate advocate for emergency
nurses. In 2012, she received the
Nebraska Nurses Association’s
Outstanding Achievement in Nursing
Award for successfully fighting to pass
legislation making assaulting a health
care provider a felony in her state.
‘‘No organization has the depth and
talent found within ENA’s
membership,’’ said Wiley, an ENA
member since 1997. ‘‘The tremendous
respect I have for ENA members
makes me appreciate the great honor
of serving as secretary/treasurer all the
more. I’ll work diligently to serve and
represent all members.’’
DirectorsThe following candidates were elected
to three-year terms (Jan. 1, 2015-Dec. 31,
2017) on the ENA Board of Directors:
Jean A. Proehl,
MN, RN, CEN,
CPEN, FAEN, is
principal and
clinical nurse
specialist at Proehl
PRN, LLC, in
Cornish, N.H; a
per diem
emergency nurse and life support
Kathleen E. Carlson
THE VOTES ARE IN ...By Amy Carpenter Aquino, ENA Connection
Karen K. Wiley
Jean A. Proehl
Official Magazine of the Emergency Nurses Association 7
instructor at Dartmouth-Hitchcock
Medical Center in Lebanon, N.H., and a
per diem emergency nurse at Gifford
Medical Center in Randolph, Vt.
Proehl served on the ENA Board of
Directors from 1993 to 2000 and was
the 1999 president. She served on the
ENA Foundation Board of Trustees and
as chair of the Academy of Emergency
Nursing Board and several national
ENA committees and workgroups. She
has received several national ENA
awards, including the ENA Foundation
Pillar Award, the President’s Award,
the Judith C. Kelleher Award and the
Education Award. She was inducted
into AEN in 2005.
‘‘I thank the members for placing
their trust in me,’’ said Proehl, an ENA
member since 1982. ‘‘I look forward to
promoting transparent decision-making
processes driven by the members’
values and desires. I will do my best to
ensure that ENA’s reputation for
high-quality products and intellectual
property is maintained and enhanced.’’
Patricia Kunz
Howard, PhD,
RN, CEN, CPEN,
NE-BC, FAEN,
FAAN, is the
director of
emergency
services for UK
HealthCare in
Lexington, Ky.
Howard served on the ENA Board
of Directors from 2000 to 2006 and was
the 2005 president. She was the 2010
chairperson of the ENA Foundation
Board of Trustees and has served as
chairperson of several national ENA
committees and workgroups. She is the
2013-14 chairperson of the ENA
Trauma Committee. Howard was
inducted into the Academy of
Emergency Nursing in 2008 and the
American Academy of Nursing in 2012
and was the 2011 recipient of the
Judith C. Kelleher Award.
‘‘I am deeply honored that the
members trust me to represent their
views and interests,’’ said Howard, who
joined ENA in 1989. ‘‘Transparency,
integrity and commitment to the
profession are the values that will
guide my member-driven decisions
while serving as a director.’’
Nominations CommitteeThe following candidates were elected
to the Nominations Committee:
Robyn R.
Larkin, BSN, RN,
CEN, was elected
to represent
Region 1. Larkin
is an ED charge
nurse/educator at
Davis Hospital
and Medical
Center in Layton, Utah.
‘‘I am so excited to be part of ENA
by serving on the Nominations
Committee,” Larkin said. ‘‘It really takes
my commitment to ENA to a higher
level. I will try to work diligently with
other committee members while
learning my new position. Thank you
for the opportunity to serve you.’’
Terry M. Foster,
MSN, RN, CCRN,
CEN, CPEN,
FAEN, was elected
to represent
Region 3. Foster is
an ED critical-care
clinical nurse
specialist at St.
Elizabeth Medical Center in Edgewood,
Ky. He has represented Region 3 on
the Nominations Committee since 2012
and is a recipient of the ENA Lifetime
Achievement Award and the Judith C.
Kelleher Award.
‘‘I consider it an important
responsibility to be able to represent
my colleagues in emergency nursing,’’
Foster said. ‘‘I am also honored that
the membership has re-elected me to
this committee. During the past two
years that I have served on the
Nominations Committee, I have
learned an incredible amount of
information regarding the election
process at the national level. One of
my main goals will be to continue to
work on increasing our voter
participation in our national election.
Every vote truly does count.’’
Lucinda W.
Rossoll, MSN,
RN, CEN, CPEN,
CCRN, was
elected to
represent
Region 5. Rossoll
is a bedside RN at
Alice Peck Day
Memorial Hospital in Lebanon, N.H.
She has represented Region 5 on the
Nominations Committee since 2012.
‘‘I am very honored to have been
re-elected to the Nominations
Committee,’’ Rossoll said. ‘‘The next
several years in ENA will be
challenging to all of us as we proceed
from two meetings to one. This change
process presents a large challenge to
the Nominations Committee and the
work it needs to do. We want to
ensure that candidate information gets
out to our members in a timely fashion,
that we have an increase in member
voting participation, and to have a
smooth election process. Thank you to
all who participated in this election, as
it is an integral part of our organization
now and in the future.’’
Patricia Kunz Howard
Terry M. Foster
Robyn R. Larkin
Lucinda W. Rossoll
8 August 2014
For more information, visit www.enafoundation.org
ENA Foundation State Fundraising ChallengeThank You for Building a Strong FoundationThe results are in...$113,000 raised!
How did your state stack up? þ Largest percentage increase per capita - Montana
þ Largest number of individual donations per state - South Carolina
þ Can your state raise more than $5000? - Yes! California, Colorado, Georgia, Illinois, Kentucky, Maryland, New Jersey, New York, South Carolina, Tennessee, Texas
ENA Foundation State Challenge_Connection_half_08 2014.indd 1 6/25/14 3:54 PM
desaturation could be related to poor
patient positioning, or it could be a sign of
deteriorating patient condition. The alarm
was addressed; however, the care team
was not notified. In the next example,
signing off on a high-risk, double-check
medication without actually double-
checking the medication could easily lead
to a medication error. Interrupting a
co-worker while she is preparing
medications is a recipe for an error.
Ineffective and incomplete handoffs are
the root cause of many sentinel events.
Why do we engage in at-risk
behaviors? The list of reasons is long.
Perhaps we are just helping a colleague.
Maybe we think, ‘‘I have taken this
shortcut before and nothing bad has
happened.’’ It’s possible we trust our
teammates to not make a mistake, so we
don’t feel the need to complete
independent double-checks. Sometimes,
we engage in at-risk behaviors because
we don’t understand the relationship
between these behaviors and errors in
health care.
In a just culture, we recognize that
humans make mistakes. We need to do a
better job of understanding how our
at-risk behaviors impact patient safety. We
cannot afford to take shortcuts, nor can
we work around existing processes that
are designed to improve safety and
decrease the risk of error. Each of us has
a responsibility to take the time we need
to keep our patients and each other safe
in the ED. We need to work within the
systems that are designed to keep us safe,
not around them. We need to speak up
when there is an issue that impacts safety,
and we need to commit to doing
everything we can to create a safe
environment in our departments.
Just being a human being sets us up to
make a mistake. Don’t let your at-risk
behaviors in the ED make these errors
inevitable.
Deadline: Wednesday,
Aug. 20, 5 p.m. CDT
ENA will honor members
who have died in the last
year during a special
memorial presentation at the
2014 General Assembly in
Indianapolis. If you would
like to recognize a member
who has died, please
complete the request form in
the General Assembly area
(members only) at www.
ena.org. All requests must
be submitted electronically
Call for Memorial Requests at 2014 ENA General Assembly
From the President Continued from Page 3
ENA received notice this spring that the American Nurses
Credentialing Center's Commission on Accreditation
recognized it as an approver of continuing nursing education
through July 31, 2018.
The four-year approval period is the maximum
certification time that ANCC gives to approver units.
‘‘We demonstrated that we are able to approve programs,
and we got the maximum four-year period,’’ said Janet
Crawford, MSN, ACNS-BC, DNC, the ANCC lead nurse
planner and nurse peer-review leader for ENA. She noted
that fulfilling the requirements and report for ANCC by the
deadline ‘‘was a lot to do in short period of time.’’
Crawford dedicated the end of 2013, including over the
holidays, to completing the report and says the result was
worth it.
‘‘The outcome makes me happy,’’ she said. ‘‘The review
process was very extensive. ANCC reviewed everything to
make sure that things were perfect, and then there was a
qualitative component.’’
Effort and cooperation from ENA members and staff, plus
the clear expectations set by ANCC, helped ENA attain the
approver unit recognition.
‘‘The membership component was wonderful,’’ said
Crawford, citing extraordinary effort across the organization,
from volunteer peer reviewers to the ENA Board of Directors.
‘‘The peer reviewers were wonderful. They were very helpful
because when we had to change, and all the forms . . . they
had to learn the entire new process. We had orientation and
education the first week in January, and it was a 100 percent
turnout — 100 percent! That’s how everybody was: People
just cooperated with this in such a wonderful way.’’
Members of ENA chapters and state councils helped by
adapting seamlessly to the newly implemented process, and
the board of directors made necessary changes to the peer
reviewer requirements, even changing the name of the
Education Committee to the Peer Review Education Committee.
Crawford credited the ENA WebUpdates team for
showcasing ENA’s commitment to green technology by
housing all required documents at www.ena.org, which
allowed ANCC appraisers to view everything online.
‘‘WebUpdates are our partners in making sure that all of
our forms are fluid, so that whenever ANCC makes a change,
they’re ready to help us make that change,’’ she said.
Other ENA departments, including teams that support
conferences, research and practice poster sessions, have
been very active in updating procedures, Crawford said.
Now that ENA has ANCC approver unit certification, the
organization can work toward the next goal of attaining
provider unit certification and even achieving ANCC premier
recognition, which Crawford estimates should take about
two years.
‘‘Ultimately, I want to make sure that when it comes to
nursing education, a member or an emergency room nurse
only needs to come here and get all of their credentialing
needs for licensure, for continuing education, as well as for
any certification,’’ she said. ‘‘We need to meet all their needs,
so this is where we’re going.’’
The beneficiaries of all this work are ENA members, who
will be able to plan educational programs through ENA
chapters and state councils and know they are covered by
ANCC for the next four years.
‘‘As long as we have that stamp of approval of ANCC and
being accredited, that certificate is recognized worldwide
because ANCC is international,’’ Crawford said. ‘‘All they
have to do is see ANCC and ENA and they’re covered. They
know that when they come here, they can maintain those
contact hours. It’s a big value.’’
Official Magazine of the Emergency Nurses Association 9
ACCREDITATION
APPROVED TO THE MAXANCC Recognizes ENA
as CNE Approver Into 2018By Amy Carpenter Aquino, ENA Connection
WITH THEIR HELPThe members of the Peer Review Education Committee were instrumental in ANCC’s recognition of ENA as a CNE approver through July 31, 2018.
• Joan S. Eberhardt, MA, RN, CCRN, FAEN, Chairperson
• Lisa M. Eckenrode, MSN, MBA, RN, EMT-P
• LTC Sandra F. Fonkert, MSN, RN, CEN, CPEN
• Marie E. Garrison, MSN, RN, EMT-I, CEN
• Trisha A. Iacobucci, DNP, RN, CPEN
• Colleen Marie Martella, MS, RN, NP, NP-C
• Elizabeth Ann Mizerek, MSN, RN, CEN, CPEN
• Geraldine F. Muller, MSN, RN, CEN
• John T. Schmidt, DNP, MSN, RN, EMT-P, CEN
• Rebecca L. Zumbo, BSN, RN, CEN, CCRN
• Joan Somes, PhD, MSN, RN, CEN, CPEN, FAEN, 2014 ENA Board Liaison
Speeding down a narrow country
road in Salem, Ore., almost turned
deadly for Josh Martinson and his
friends last year when he lost control of
the car at more than 125 mph.
The four 16-year-old Sprague High
School students had decided to go ‘‘hill
hopping,’’ a dangerous activity in
which the driver speeds down a rural
road and accelerates before the top of
a hill to make the car go airborne.
Though Martinson was impaled
through the shoulder by a fence post,
he and his friends survived without
any permanent injuries and were
treated at Salem Hospital.
When another hill-hopping accident
occurred in the same area three weeks
later, killing the 19-year-old driver and
leaving the other two teen passengers
in serious condition, trauma nurse Kelly
Owen, RN, ADN, CEN, knew something
had to be done to decrease the number
of teens presenting to her emergency
department because of hill hopping.
‘‘As an emergency room nurse, these
are some of the things I get to see, and
I see the impact it has on their families,
on the community and their fellow
students,’’ said Owen, Salem Health’s
trauma services and injury prevention
coordinator. ‘‘These are good kids who
are making bad choices. It’s just tragic
when we’re losing young lives
needlessly. And these events are 100
percent preventable. They don’t have
to happen.’’
Owen said hill hopping is common
in Salem among teenagers because of
the rolling hills in the area. With more
than 10 years of experience in injury
prevention, Owen actively searches for
ways to educate students on safety
issues. She encourages emergency
nurses to keep their eyes open for
educational opportunities.
‘‘There are opportunities out there,
August 201410
HOP-STOPPING VIDEOENA Honoring Member Who Put a Camera on Dangerous Teen TrendBy Kendra Y. Mims, ENA Connection
Official Magazine of the Emergency Nurses Association 11
especially in the ED. We see a lot,’’
she said. ‘‘I have a dual role as an
emergency room nurse and an injury
prevention nurse, so I think differently.
I see through two sets of glasses. I see
tragic things in the emergency room,
but then I am always looking for ways
to prevent those things. I’m always
looking for stories to tell and ways to
use those stories as education.’’
Martinson’s hill-hopping accident
inspired Owen to interview him and
his passengers and create a video that
would allow them to share their story
with other teens, including why they
decided to engage in the dangerous
activity.
‘‘I suspect their choice was
probably the same as ones other kids
make,’’ Owen said. ‘‘But I wanted to
go further and have them share what it
felt like to be in a car crash. Was it
painful? Was it scary? What did it feel
like to be a trauma patient and have a
pole go through your shoulder? What
lessons did you learn? Was it really
worth it? What advice would you give
to other kids who are thinking about
doing the same thing?’’
The teens and their parents were
excited about the idea, as they were
looking for an opportunity to raise
awareness about the dangers of hill
hopping.
During the interview process,
Owen, video producer Mark Glyzewski
and Vicki Kimpton, Owen’s injury
prevention partner, separated the teens
from each other and their parents to
get authentic responses.
‘‘We got consent from both the kids
and parents to interview them
Driver Josh Martinson, now 17, bears ghastly scars where a pole impaled him through the back and shoulder in a high-speed crash in Salem, Ore. (top and opposite page).
SEE FOR YOURSELFKelly Owen’s video, which will be honored with this year’s ENA Media Award, can be viewed on YouTube by visiting tinyurl.com/hillhopping or scanning the QR
code here.
WARNING: This video contains graphic images.
Continued on next page
August 201412
separately,’’ Owen said. ‘‘We wanted
them to be honest because it’s
important. I feel they gave really
honest answers, and I really appreciate
that about them. It’s tough for
teenagers to admit that they made a
bad choice, especially on camera.’’
The six-minute video, featuring the
four teens talking about their close call
with death and the dangers and
consequences of hill hopping, shows
graphic photos of their injuries from the
accident scene and the hospital. It also
includes interviews from the Salem
firefighter/paramedic who cut
Martinson out of the car and the Salem
Hospital trauma surgeon who treated
Martinson’s soft-tissue injury. The
surgeon explains how Martinson’s
injury could have been fatal if the fence
post had struck him a few inches lower.
The video is shown at schools in
the Northwest as a part of the injury-
prevention program Trauma Nurses
Talk Tough, which originated in
Oregon. Owen said she has numerous
opportunities to show the video to
teens in driver’s education classes
throughout the area and health classes
at local high schools.
‘‘I’m constantly looking for
educational opportunities to teach kids
something,’’ Owen said. ‘‘This video is
a great injury-prevention tool, and
anyone who teaches injury prevention
can use it. It’s a great video because
it’s coming directly from the kids who
have experienced this, and they are
talking to other kids about the dangers
of it. It’s a peer-to-peer thing, and I
think that holds a lot of credibility.
And that was the vision, intent and
purpose behind the video.’’
Since its release in July 2013, Owen
said the video has been shown to
about 3,800 students in 27 classes and
has almost 60,000 views on YouTube.
KGW-TV in Portland featured the story
and video on its website last July.
During her presentations, Owen has
received positive feedback from
students who have viewed the video.
She believes the messages, such as the
importance of wearing a seat belt and
the dangers of speeding and distracted
driving with other teenage passengers,
are resonating with students.
‘‘This is a great story to tell, and it
has a lot of important messages,’’ she
said. ‘‘It’s interesting that since we’ve
debuted the video last summer, we
haven’t had any more hill-hopping
crashes. They are getting the
information.’’
Owen will receive this year’s ENA
Media Award on Oct. 11 during the
Awards Gala at the ENA Annual
Conference in Indianapolis. The award
recognizes a media presentation
(television, radio, Internet or print) that
portrays emergency nursing in a
positive, accurate and professional
manner and may have been created to
educate the consumer about
emergency nursing/emergency care
issues or advocate for issues in
emergency nursing/emergency care.
Owen is excited that Martinson and
his parents, Kimpton and Glyzewski
will be joining her at the gala.
‘‘A media award is not an individual
award,’’ she said. ‘‘It was my vision,
but it was a team effort and would
have never happened without Mark
Glyzewski, Vicki Kimpton or the teens
agreeing to do it.
‘‘We’re very excited about this
award. Hopefully this will be another
way to get this video out there to other
nurses who could use this video in
their area of education. The more
people that can see this video, the
more it can be used, and the better the
outcome.’’
‘‘I wanted to go further and have them share what it felt like to be in a car crash.
Was it painful? Was it scary? What did it feel like to be a trauma patient and have a pole go through
your shoulder? What lessons did you learn? Was it really worth it? What advice would you
give to other kids who are thinking about doing the same thing?”
KELLY OWEN, RN, ADN, CEN (left) with video producer Mark Glyzewski
Josh Martinson and his mother, Shonna, will attend the ENA Awards Gala, where Kelly will receive her award Oct. 11.
Hill Hopping Continued from previous page
Details Matter.
When it comes to the equipment you use every day, with every patient, details matter. That is why we spent so much of our attention during the design of the Prime TC Transport Chair on the Flip-Up Footrests with Swing Away.
Flip-Up Footrests remain in an upright position until pressure is applied to reduce trip hazards.
A lip at the edge allows caregivers to flip the footrest down for the patient, which reduces the need to bend over and touch dirty footrests.
Simply stepping on the yellow button swings the footrest back, and completely out of the way for access to the patient, and to provide clearance during lateral transfers.
Contact your local Stryker Account Manager, or stop by Stryker booth #301 at the ENA Annual Conference in Indianapolis to experience the footrests on the Prime TC Transport Chair.
T he United Arab Emirates, situated
near the end of the Arabian
Peninsula on the Persian Gulf, was the
location of ENA’s most recent
dissemination of Trauma Nursing Core
Course on May 19-30.
The UAE is comprised of seven
emirates: Ajman, Dubai, Fujairah, Ras
al-Khaimah, Sharjah, Umm al-Quwain
and Abu Dhabi, which is the largest
emirate as well as the capital. The
courses were conducted at Al Rahba
Hospital in Abu Dhabi. The
dissemination team included ENA
members Tim Murphy, MSN, RN,
ACNP-BC, CEN, course director; Deena
Brecher, MSN, RN, APN, ACNS-BC,
CEN, CPEN, 2014 ENA president;
Margot Daugherty, MSN, MEd., RN,
CEN; and Sandy Waak, RN, CEN.
Al Rahba Hospital is a Joint
Commission International-accredited
facility affiliated with Johns Hopkins
Medicine International. Al Rahba is
also a member of the Abu Dhabi
Health Services Company, or SEHA,
which is owned by the Abu Dhabi
government. SEHA, the Arabic word
for health, includes 12 hospitals, many
of which were represented by nurses
attending the inaugural courses.
ENA made a previous TNCC
dissemination to the UAE nearly a
decade ago. The original UAE
instructors’ status had expired after the
sixth-edition update, and the contract
with the original organization was no
longer active. Al Rahba expressed the
desire to assume the contract to teach
August 201414
COURSES
By Tim Murphy, MSN, RN, ACNP-BC, CEN; Margot Daugherty, MSN, MEd., RN, CEN; Sandy Waak, RN, CEN; and Deena Brecher, MSN, RN, APN, ACNS-BC, CEN, CPEN
TNCC TRAVELS WELL
Continued on page 16
Health care workers (at table, clockwise from left) Imelda Oao, Rani James, Kristina Mae Cabato and Terry Sumahit follow along with instructor Ahmad Aldizdar (right, face not pictured) as they practice with a pediatric mannequin during their TNCC course in Abu Dhabi, United Arab Emirates, in May. ENA faculty member Margot Daugherty looks in on the background.
Worlds Come Together During Seventh-Edition Dissemination in Abu Dhabi
Official Magazine of the Emergency Nurses Association 15
The Emergency Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
2 Day Intensive Course § 24 Chapter Comprehensive Manual § Hands-on Skill Stations 5 Online Modules § Special Population Chapters § 17.65 Contact Hours
SEVENTH EDITION
The Premier Course for Trauma Care
Available NowVisit www.ena.org/TNCC to find a course near you.
TNCC, widely recognized as the premier course for hospitals and trauma centers worldwide, empowers nurses with the knowledge, critical thinking skills, and hands-on training to provide expert care for trauma patients.
§ Rapid identification of life-threatening injury § Comprehensive patient assessment § Enhanced intervention for better patient outcomes
TNCC Ad_Connection_Half_08 2014.indd 1 6/25/14 4:02 PM
ENA sets the standard for international nursing
trauma care. Emergency nurses around the world have seen the value in becoming verified in ENA’s courses, including Trauma
Nursing Core Course, Emergency Nursing Pediatric Course and Course in Advanced Trauma Nursing-II.
ENA developed and implemented TNCC for national and international dissemination as a means of identifying a standardized body of trauma nursing knowledge. The purpose of TNCC is to present core-level knowledge, refine skills and build a firm
foundation in trauma nursing.
ENA developed ENPC to improve the care of the pediatric patient by increasing the knowledge, skill and confidence of
the emergency nurse.
This two-day course provides core-level pediatric knowledge and psychomotor skills needed to care for pediatric patients in the emergency care setting. ENPC is the only pediatric emergency nursing course written by pediatric nurse experts.
A new, Web-based version of CATN is expected to be released in early 2015, replacing the retired CATN-II course.
Below is a list of countries and the years when they began hosting ENA course instruction:
TNCCAruba – 2007Australia – 1993Canada – 1993
Greece – 2008Hong Kong – 1999Netherlands - 1996Norway – 2001Portugal – 2001Sweden – 1996South Africa – 2006South Korea – 2010United Arab Emirates – 2005; 2014United Kingdom – 1998
ENPCAustralia – 1995Canada – 1997Netherlands – 2001Portugal – 2005Sweden – 2001
CATN-IIAustralia – 2004Canada – 2003Netherlands – 2006United Kingdom – 2006
ENA COURSES AROUND THE WORLD
TNCC in the UAE. Murphy was also a member of the original
dissemination team and appreciated the significant growth
throughout the country since his last visit.
In 2008, there was a multiple-casualty incident involving
more than 250 injured patients who were transported to Al
Rahba Hospital after a multi-vehicle pileup during which a
petroleum tanker caught fire and exploded. There were eight
deaths and little warning before the transport of the patients
to Al Rahba. As a result of this experience, Al Rahba, with the
support of SEHA, has assumed a leadership role in the
development of a trauma system.
The American College of Surgeons Committee on Trauma
conducted a trauma consultation at Al Rahba to begin
preparations for trauma center verification. Providing TNCC
verification for nurses is a central component of the quest for
designation. Elijah Gilreath Jr., MSN, RN, CS, CMCN, chief
nursing officer, along
with John Britton Beatty,
RN, assistant director of
nursing, advocated to
SEHA and secured
support to bring the
TNCC dissemination
team to Al Rahba.
Gilreath and Beatty are
strong supporters and
advocates of TNCC.
Norman Avila, RN, the
trauma program manager
and one of the previous
TNCC instructors, worked
17 Interactive Modules15.21 Contact Hours
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GENE provides: § Best geriatric practices from triage
to discharge § Patient and family education § Learning material for all healthcare
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Purchase Today! Group Pricing Available
www.ena.org/geneThe Emergency Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
GENE Ad_Connection_half vertical_0607 2014.indd 1 5/6/14 1:42 PM
August 201416
TNCC in Abu Dhabi Continued from previous page
ENA 2014 President Deena Brecher, MSN, RN, APN, ACNS-BC, CEN, CPEN, presents a certificate of completion to TNCC instructor candidate Iman Yassin.
Instructor candidate Rahma Warsama at a skill station.
Official Magazine of the Emergency Nurses Association 17
tirelessly to facilitate resources
necessary to host the dissemination.
Al Rahba has a culturally diverse
group of employees representing more
than 60 countries. The TNCC students
were representative of this cultural
diversity. Although Arabic is the official
language of the UAE, teaching
occurred in English. The ENA team
was warmly welcomed by the hospital
leadership on arrival. A tour of the
hospital revealed a well-equipped and
staffed facility, similar to any U.S.
facility. The team was particularly
impressed with a ‘‘homegrown’’ ED
dashboard that displayed unit-based
metrics measuring physician-to-patient
time and length-of-stay information on
a large-screen monitor with color
coding, which was visible to the entire
staff. During the visit, a paperless
documentation system was being
implemented.
The nurses selected to participate in
the inaugural provider courses were
truly exceptional. Each came to class
prepared and thoroughly engaged. The
team was humbled and excited to work
with such a fine group of nurses. As in
all TNCC courses, learning is a two-way
street, with instructors benefiting from
student experiences as much as
students learn from the instructors. This
course was no exception.
The ENA team encountered several
practice differences. One medical/legal
issue was the lack of advance directives,
which changed considerations for one
of the teaching scenarios. From a clinical
standpoint, there is almost no
penetrating trauma because guns are not
legal in the UAE. In addition to motor
vehicle collisions, falls account for a
significant amount of trauma because of
the large number of construction
projects throughout the region.
At the conclusion of the first
provider course, the ENA team
identified a number of instructor
candidates who attended the first
instructor course. After the second
provider course, the team identified
four of the new instructors as course
directors and faculty. It will be their
responsibility to develop a trauma
committee in the UAE and promulgate
further courses. They have a very
aggressive plan supported by the
hospital leadership to start teaching;
there is no doubt they will be
successful. The support of the entire
leadership team at Al Rahba and SEHA
is unparalleled, and the ENA team
wishes them the best.
The team found that the work with
its UAE colleagues was the most
rewarding part of the trip and has
every confidence that TNCC will
flourish under their leadership. Team
members would enjoy seeing their UAE
colleagues again, perhaps at an ENA
conference. The team members found
themselves both personally and
professionally enriched through this
experience.
PROVIDER COURSE: Front row (from left): Margot Daugherty, Deena Brecher, Sandy Waak, Tim Murphy. Middle row: Samer Awad, Ivy Mendoza, Iman Yassin, Lity John, Ma-Teresa Laude, Maysoon Enouz, Amna Darwish, Helen Caulfield. Back row: Bindu Anthony, Rahma Warsama, Nazir Ahmad, Yehia AlBuhaisi, Ahmad Aldizdar, Norman Avila, Vinod Hareendrannair, Adrian Dobson.
INSTRUCTOR COURSE: Front row (from left): Margot Daugherty, Deena Brecher, Sandy Waak, Tim Murphy. Back row: Iman Yassin, Bindu Anthony, Nazir Ahmad, Norman Avila, Vinod Hareendrannair, Ahmad Aldizdar, Lity John, Rahma Warsama, Amna Darwish.
WELLNESS AND SAFETY
Pedestrian Safety Act of 2014With more than 100 fatalities and
thousands of injuries involving
pedestrians recently occurring on Long
Island and Hudson Valley’s main
roads 3, U.S. Sen. Kirsten Gillibrand
(D-N.Y.) proposed a bill that would
allow localities to use federal highway
safety funds for pedestrian safety
projects.
Currently, the federal government
fully funds specific highway safety
projects for states, primarily centered
on vehicles and motorists. The Senate
Environmental and Public Works
Committee endorsed Gillibrand’s
Pedestrian Safety Act of 2014 in May.
The act seeks to improve the safety of
pedestrians, particularly children and
older adults, by updating automotive
design standards, incentivizing
additional pedestrian roadway
improvements and providing more
federal assistance for public awareness
and educational campaigns.
ENA supports the Pedestrian Safety
Act of 2014, which would increase
pedestrian safety in the following three
ways:
1. Raise safety standards on motor
vehicles to reduce pedestrian injury.
2. Increase federal funding to
improve pedestrian-safety-related
roadway conditions, such as crosswalk
signals and highway crossing islands.
3. Increase federal funding for state
and local pedestrian safety campaigns.
Everyone is a PedestrianThe U.S. Department of Transportation
launched the ‘‘Everyone is a
Pedestrian’’ campaign last year to help
communities decrease the number of
pedestrian fatalities and injuries and
reduce dangers. NHTSA and the
Federal Highway Administration
launched www.nhtsa.gov/
everyoneisapedestrian to provide
road users and communities with
safety tips, research and educational
resources to raise awareness and
increase pedestrian safety. In an effort
to help cities that have some of the
highest rates of pedestrian deaths
nationwide, NHTSA also awarded
three grants totaling about $1.6 million
to Louisville, Philadelphia and New
York to raise awareness, provide
education and implement enforcement
initiatives.4
Decade of Action
Pedestrians were one of the few
groups of U.S. road users to
experience an increase in fatalities in
2012. The World Health Organization
has created a 10-year goal for
its global campaign to improve
pedestrian safety.
The WHO designated 2011-2020 as
the ‘‘Decade of Action for Road Safety
to save 5 million lives.’’ It reported that
46 percent of fatalities on the world’s
roads are ‘‘vulnerable road users’’:
pedestrians, cyclists and motorcyclists.
Part of the global plan includes safer
roads and mobility for pedestrians,
such as improving the safety-conscious
planning, design, construction and
operation of roads and making sure
roads are frequently evaluated for
safety.5
New Vehicle Technology Engineers are working on
improvements to vehicles that could
protect pedestrians and decrease the
extent of their injuries in traffic
accidents. The Insurance Institute for
Highway Safety reports that although
deaths in all other types of passenger
vehicle collisions have decreased
significantly during the last decade,
pedestrian fatalities account for an
increasing percentage of accident
fatalities. Most pedestrian crashes
involve a single-passenger vehicle and
are frontal crashes; the most common
entails a person crossing the road and
a vehicle driving straight.6
To decrease pedestrian deaths and
injuries, IIHS recommends modifying
the fronts of vehicles. Technology
EFFORTS ARE AFOOTSteps Being Taken to Ramp Up Pedestrian Safety
August 201418
Statistics show the percentage of pedestrian fatalities has
increased over the last several years. According to the
U.S. Department of Transportation’s National Highway
Traffic Safety Administration, 4,743 pedestrians were killed
and about 76,000 were injured in traffic accidents in 2012,
accounting for 14 percent of all traffic fatalities in the United
States, which is a 6 percent increase from 2011.1
Whether people walk as a means of transportation or for
leisure, NHTSA considers everyone a pedestrian and defines
a pedestrian as any person on foot walking, running,
jogging, hiking, in a wheelchair, sitting or lying down.2
Because of the increase in pedestrian fatalities and injuries,
the following efforts are being made nationally and globally
to improve safety for pedestrians.
♦ By Kendra Y. Mims, ENA Connection
AGGRESSIVE BEHAVIOR......towards staff at work is dramatically on the increase, especially in our Hospitals. Verbal abuse, threats with weapons, cuts, punches, even serious injuries are becoming everyday occurrences. The impact on the confidence and morale of staff is damaging and costly and has a serious impact on the caring and commitment that lies at the heart of the staff/patient relationship. Installing an INSTANTalarm 5000
Staff Personal Alarm System will make a dramatic differenceINSTANTalarm does NOT• track you around the hospital• use radio-frequency• rely on unreliable wi-fi• have a computer controlling itINSTANTalarm, however, DOES• let you decide when you need help• pinpoint your location, to a room• work instantaneously• make you and your patients feel safer• reduce the frequency and impact of violent incidents
Which is why, over 20 years, INSTANTalarm 5000 has been probably the most widely-installed, staff duress alarm system in the world.
® 205.414.7541www.pinpointinc.com PROTECTING
PEOPLE AT WORK
®
being explored includes plastic hood
mounts, crushable hoods and fenders,
padding in bumpers, headlights that
break away on impact, pedestrian
airbags and crash avoidance
technology such as radar systems
designed to recognize pedestrians
entering a vehicle’s path and warn the
driver.
Brian Ericson, BSN, RN, CEN,
clinical lead nurse at the Mercy
Hospital Emergency Department in
Portland, Maine and an ENA
Emergency Nurses Wellness
Committee member,
encourages emergency
nurses to use the
following resources
to engage their
local community:
♦ www.nhtsa.gov/
Pedestrians
♦ www.cdc.gov/
MotorVehicleSafety/Pedestrian_
Safety/pedestrian.html
♦ www.safekids.org/
walkingsafelytips
♦ safety.fhwa.dot.gov/ped_bike/
‘‘I don’t think people realize that
pedestrian fatalities have been on an
upward swing for the last three years,’’
Ericson said. ‘‘Statistics indicate that
someone is dying every two hours and
getting injured every 15 minutes.
There are a number of efforts
being made to reverse this
trend, but one that I
think emergency
nurses need to
focus on is
education.
This
would
be a
super topic
to engage your
community with,
and there are lots of
resources available to
make it happen.’’
References
1. National Highway Traffic Safety Administration. (n.d.). Everyone is a pedestrian. Retrieved from www.nhtsa.gov/nhtsa/everyoneisapedestrian/index.html
2. National Highway Traffic Safety Administration. (2013). Safety in numbers. Retrieved from www.nhtsa.gov/nhtsa/Safety1nNum3ers/august2013/SafetyInNumbersAugust2013.html
3. Office of Sen. (NY) Kirsten Gillibrand. Key Senate committee passes Gillibrand measure to improve pedestrian safety on New York roadways, reduce fatalities and injuries. (2014, May 15). Retrieved from www.gillibrand.senate.gov/newsroom/press/release/key-senate-committee-passes-gillibrand-measure-to-improve-pedestrian-safety-on-new-york-roadways-reduce-fatalities-and-injuries
4. National Highway Traffic Safety Administration. U.S. Department of Transportation announces winners of pedestrian safety grants. (2014, April 25). Retrieved from www.nhtsa.gov/About+NHTSA/Press+Releases/2014/U.S.+ Department+of+Transportation+Announces+ Winners+of+Pedestrian+Safety+Grants
5. World Health Organization. (2011). Decade of action for road safety 2011–2020: Saving millions of lives. Retrieved from www.who.int/violence_injury_prevention/publications/road_traffic/saving_millions_lives_en.pdf
6. Insurance Institute for Highway Safety. (2013). Softer vehicle fronts and pedestrian detection systems could reduce pedestrian deaths, injuries. Retrieved from www.iihs.org/iihs/sr/statusreport/article/48/10/3
Official Magazine of the Emergency Nurses Association 19
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”
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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It has been said that emergency
nursing and teaching kindergarten
are the professions that require the
widest variety of attributes to be
successful. Emergency nurses certainly
use various skills and abilities at all
times. Beyond specific clinical skills,
perhaps one of the most important
skills is a well-developed EI, or
emotional intelligence. EI, sometimes
referred to as EQ, has been identified as
the factor that determines success more
than education, experience or IQ.
Think of those with whom you have
worked. We all know people who have
high IQs, advanced degrees and
breadth of experience but are not very effective in their
bedside skills or as a team member. They are not considered
to be on the ‘‘A’’ team. Why is this, and why is it so
important, especially for emergency nurses?
Emotional intelligence is comprised of five elements in
two dimensions: intrapersonal (self-awareness, self-
regulation, motivation) and interpersonal (empathy, social
skills). These sound like requirements for any emergency
nurse. While we typically do not screen new candidates in
these areas, a high level of proficiency in each of these EI
components is needed for success. Here is the success
formula:
IQ + Education + Experience (opens door to an emergency nursing job)
+EIProficiency (self-awareness, self-regulation, motivation,
plus empathy, social skills) = Success!
Self-awareness is the first step in being able to handle a
situation effectively. As emergency nurses, we need to be
aware of several areas that impact our self: emotions, values,
prejudices and personal stress. Our perspective in each of
these areas may, at times, create a problem or conflict in
dealing with others. Often, we need to self-regulate our
natural response. Can you
imagine a situation when an ED
staff member did not practice
self-regulation? We likely all
remember a time when that
happened. It probably was not
pretty and created even more
stress. Motivation is essential not
only for teamwork but also for
personal growth. The team
depends on everyone taking the
initiative to pick up patients, help
others and be knowledgeable
and capable in all aspects of
emergency nursing. These three
intrapersonal aspects of EI are
crucial to who we are as emergency nurses.
The two interpersonal aspects of EI are also essential.
Empathy, the ability to understand the emotions of others, is
important as we need to provide care in a way that makes
patients feel cared for. The final aspect of EI, social skills, is
necessary in working effectively with teammates and with
patients and families. ED teams are unique, and the unique
combinations of assignments and roles require astute,
adaptable social skills. Add physicians, ancillary staff,
emergency medical services and inpatient units and you
have even more challenges. In addition, emergency nurses
interact with patients of all ages and families from every
spectrum of society at a moment’s notice, without time to
prepare. This requires a high level of comfort and ease with
meeting and talking with unfamiliar people.
Emergency nursing can be stressful and requires each of
us to be our best. It requires a complex skill set, so much
more than book knowledge and clinical know-how. To be
highly effective, we also have to show great intrapersonal
and interpersonal EI skills. When this is done, the team feels
privileged to work with you, and your patients and families
are thankful that you are their nurse.
Resources
Freshman, B. (2002). Emotional intelligence: A core competency for health care administrators. The Health Care Manager, 20(4), 1-9.
Target Training International, Ltd. (2013). TTI Emotional Quotient™ debriefing guide. Scottsdale, AZ: TTI Success Insights.
Official Magazine of the Emergency Nurses Association 25
By Yvonne Prowant, MM, BSN, CEN, Emergency Nurses Wellness Committee Member
THE OTHER INTELLIGENCEDo You Have a Strong EI? Your Success Could Depend On It
W hen Elizabeth Mizerek, MSN,
RN, CEN, CPEN, FN-CSA,
realized the majority of prevention
efforts for catheter-associated urinary
tract infections weren’t focused on the
emergency department, she decided to
conduct her own research to address
CAUTI from the emergency nurse’s
perspective.
‘‘Catheter-acquired urinary tract
infections are a never event and a Joint
Commission national patient safety
goal,’’ said Mizerek, ED educator at the
Robert Wood Johnson University
Hospital Hamilton in Hamilton, N.J.
‘‘There’s been a lot of work done
around CAUTI prevention efforts with
the Surgical Care Improvement Project,
but no one’s really talked to the ED.’’
Mizerek wanted to explore the
emergency nurse’s decision-making
process when considering Foley
catheter insertion. She was a 2013
recipient of an ENA Foundation seed
grant, which gave her an opportunity
to conduct a qualitative study.
‘‘I think there was an assumption
that a physician writes an order to
have a Foley catheter inserted and the
nurse places it,’’ she said. ‘‘By doing
the qualitative research, we found that
the catheter insertion decision was
really nurse-driven more than
provider-driven. And that turned the
whole paradigm on its head.’’
For her research project, ‘‘Foley or
No Foley: Factors Influencing
Emergency Nurse’s Decision to Insert
an Indwelling Urinary Catheter,’’
Mizerek and her colleagues from the
New Jersey ENA State Council
conducted three focus-group sessions
with a total of 23 participants at the
annual New Jersey ENA Emergency
Care Conference in March. After
analyzing the data, she discovered
emergency nurses were driving the
decision-making based on their clinical
judgment, and the majority did not
have a demonstrated competency. She
also found a wide variability in the
frequency of catheter insertions.
Mizerek said there’s definitely a
lack of communication and
understanding about the impact of
CAUTI on the patient. She believes this
research can help raise awareness and
educate emergency nurses.
‘‘We need to have a better approach
to our CAUTI prevention efforts to
prevent patient harm,’’ she said.
‘‘Hopefully this research will help to
inform the CAUTI prevention programs
going on across the country to really
spend time looking at their processes,
education and how they are
communicating to people providing
direct patient care. Part of our study
shows that the bedside nurse is not
receiving information to understand the
impact of the preventable patient harm
of CAUTI.’’
Mizerek recently submitted her
research manuscript to the Journal of
Emergency Nursing. She said one of
the most exciting aspects of the project
was receiving the $500 ENA
Foundation seed grant, which was
enough to get her foot in the door.
‘‘For those of us who work in a
community hospital and don’t have an
affiliation with an academic institute, it’s
really exciting to have that support from
the ENA Foundation and to know that
every time I bought a flash drive or
attended an ENA Foundation fundraiser,
I ended up funding research for myself
and others,’’ she said. ‘‘If this is what
we can do with a $500 grant, imagine
what we can do with a $2,500 grant.’’
Mizerek said the project has helped
her as an ENA mentor for Project
Protect: Infection Prevention Fellowship,
presented by the On the CUSP: Stop
CAUTI program. She hopes her research
will create a discussion about CAUTI
prevention strategies that is inclusive of
the nurse’s perspective and that
emergency nurses will continue to give
back to the ENA Foundation to support
future research projects.
‘‘It’s our foundation,’’ she said. ‘‘It’s
who we are. If ENA wants to be the
global leader in emergency nursing, it
has to start with education and research,
and that’s what the ENA Foundation is
all about. It supports those of us in the
field, whether it’s through the
educational scholarships or through
research grants. The ENA Foundation
helps advance the practice of emergency
nursing in a very concrete way.’’
ENA FOUNDATION
August 201426
“If this is what we can do with a $500 grant, imagine what we can do with a $2,500 grant.’’ELIZABETH MIZEREK, MSN, RN, CEN, CPEN, FN-CSE, 2013 ENA Foundation Seed Grant Recipient
Member Puts Seed Grant Funds Toward Keeping CAUTI Out of the EDASKING FOR OURSELVES
By Kendra Y. Mims, ENA Connection
ENA Foundation Event
“A single person can do incredible things when they set their heart to it. That’s the power of one.”
- Jeff Solheim
The Power of One: Engaging Generations of Nurses to Give Back and Do Incredible Things
Friday, October 106 – 8:30 pm2014 ANNUAL CONFERENCE INDIANA CONVENTION CENTER 1.30 CONTACT HOURS
Join the ENA Foundation and Jeff Solheim, Internationally Recognized Motivational Speaker, for an evening of exploring the Power of One—Inspiring stories of our heroes—100% of your ticket value goes to the Emergency Nursing 2015 Conference scholarship fund.
The goal of the Foundation Event is to raise money to send 10 emerging professionals to the Emergency Nursing 2015 Conference. Empowering young nurses with education, networking, and advocacy skills will give them the tools to do incredible things.
$50 (tax deductible) Dinner, dessert bar, and beverages following the program.
THE POWER OF ONE
The Emergency Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
AC14 ENA Foundation Event Ad_JEN_Full_07 2014.indd 1 6/25/14 8:37 AM
August 2014
Fellows offer many
reasons for what
motivated them to
seek induction into
the Academy of
Emergency Nursing. You may identify
among these reasons why you would
apply to become a fellow of the
Academy of Emergency
Nursing.
Fellows’ motivators can
be categorized as intrinsic
and extrinsic. Two types of
intrinsic motivators are
motivation toward
accomplishments and
motivation to
experience
stimulation.1
Three types of
extrinsic
motivators are
external regulation,
introjected regulation
and identification.1
External regulation is
modeled by current
fellows and other
colleagues
recommending others
to apply to become a
fellow. Introjected
regulation can be
exhibited by people
with a professional
responsibility to
role-model to others;
they apply to become
a fellow so that their
colleagues are more
likely to apply to the
Academy as well.
Identification is a
reason for those
applicants seeking
personal recognition by others as
having achieved a legacy in
emergency nursing.
Applicants still need to address
their potential for sustained
contributions after induction. The
Institute of Medicine, in consort
with the Robert Wood
Johnson Foundation,
called for nursing leaders
and mentors enabled to
‘‘lead change to advance
health.’’2 Fellows of the
Academy of Emergency
Nursing are ideally situated
to lead changes in
emergency care
reflecting the
induction criterion
for sustained
contributions,
which can be
demonstrated
as increased
leadership
opportunities through
mentorship and
advisement.
Mentoring
opportunities are
formalized through
the Academy’s
EMINENCE program
and informal
networking with ENA
members.
AnnMarie Papa, DNP,
MSN, RN, CEN, NE-BC,
FAEN, an ENA past
president, said a benefit of
being a fellow is being
‘‘recognized as an expert in
the profession of emergency
nursing when serving on
committees and advisory
boards to shape and influence the
future’’ of emergency nursing. Papa’s
statement reflects the advisement
occurring when Academy members are
solicited by the ENA Board of
Directors, ENA committees and
Becoming a Fellow: Which Type Are You?By Gordon Lee Gillespie, PhD, RN, PHCNS-BC, CEN, CPEN, CCRN, FAEN
2014 Academy Candidates for InductionENA and the Academy of Emergency Nursing are pleased to announce the 2014 academy candidates for induction:
• Roger Casey, MSN, RN, CEN (Washington)
• Rita Celmer, RN, CRNA, CEN (Pennsylvania) - Posthumous
• Nicholas Chmielewski, MSN, RN, CEN, CNML, NE-BC (Ohio)
• Seleem Choudhury, MSN, MBA, RN, CEN (Vermont)
• Ruth E. Rea, PhD, RN (Washington)
• Robert Ready, MN, RN-C, CPEN, NEA-BC (Rhode Island)
• Stephen J. Stapleton, PhD, MS, RN, CEN (Illinois)
• Tiffiny Strever, BSN, RN, CEN (Arizona)
• Mary Alice Vanhoy, MSN, RN, CEN, CPEN, NR-P (Maryland)
• Cheryl Wraa, MSN, RN (California)
The candidates will be inducted as fellows on Oct. 11 at the 2014 Annual Conference in Indianapolis. We extend our congratulations and appreciation to the candidates for their outstanding contributions to emergency nursing and ENA.
28
Official Magazine of the Emergency Nurses Association 29
to register visit www.ena.org/ac
A Celebration of Ínductees to the Academy of Emergency Nursing, Lantern Awards, and Annual Achievement Awards
Saturday, October 117:30 pm
JW Marriott Indianapolis
Gala 2014 AD_CONN_Half_08 2014_print.pdf 1 6/25/14 3:59 PM
T he Centers for Disease Control and Prevention and The Joint
Commission are warning health care providers to follow precautions
when administering single-dose/single-use and multiple-use vials. On
June 16, The Joint Commission released Sentinel Event Alert Issue 52:
Preventing infection from the misuse of vials.
The CDC has reported that the improper use of medication vials during
routine health care procedures, such as administering injections, has resulted
in the transmission of bloodborne viruses to patients. It further warns that
adverse events have been caused by misuse and urges basic infection control
practices to ensure patient safety.
Failure to follow simple precautions can result in the spread of the hepatitis C
and B viruses. Single-dose/single-use vial medications do not have preservatives
and are at greater risk of spreading infection when used improperly.
The following precautions are urged:
• Use a single-dose/single-use vial for one patient during one procedure.
• Do not keep used single-dose/single-use vials or combine the contents
for later use.
• Only vials labeled for multiple-dose use can be used more than once.
The full text of the alert can be found at tinyurl.com/tjcalert or by
scanning the QR code at the top of this box.
Vial Alert from CDC, Joint Commission
external advisory boards to provide
views, advice and appraisal for decision-
making and health policy.
Nancy Bonalumi, MS, RN, CEN, FAEN,
an ENA past president and the AEN
chairperson-elect said, ‘‘Being a fellow
means making a contribution, not just
making accomplishments.’’
This means that whether you apply to
become a fellow for intrinsic or extrinsic
reasons, your opportunity to meet the
IOM challenge as a leader in emergency
nursing and your future positive impact
to the profession can be actualized.
The Academy board looks forward
to reviewing members’ future
applications.
References
1. Vallerand, R. J., Pelletier, L. G., Blais, M. R., Brière, N. M., Senécal, C., & Vallières, E. F. (1992). The academic motivation scale: A measure of intrinsic, extrinsic, and amotivation in education. Educational and Psychological Measurement, 52, 1003-1017.
2. Institute of Medicine. (2010). The future of nursing: Leading change, advancing health. Washington, DC: The National Academies Press.
30
ETHICS
At the April meeting of
the National EMS
Advisory Council, we
looked at the issue of
community paramedicine,
which was also a topic at
the town hall meeting held at ENA
Leadership Conference 2014 in Phoenix. In
response to member concerns, the ENA
Board of Directors voted this spring to
create an EMS advisory council this year.
The American Nurses Association also
has come out with the statement ‘‘ANA
Essential Principles for Utilization of
Community Paramedics,’’ which can be
found at tinyurl.com/
anaprinciples or by scanning
the QR code here.
We also received an update
from the U.S. Department of Health and
Human Services that the Association of
State and Territorial Health Officials was
scheduled to release a white paper about
community paramedicine, which looked at
the legality and policy issues affecting
community paramedicine.
A U.S. Department of Transportation
Federal Highway Administration Safety
Performance Measures notice of proposed
rulemaking soon will require all states to
report serious-crash injury data to USDOT.
This will be a phased-in project in which
the details from a motor-vehicle crash will
be collected in a systematic way, regardless
of where the crash occurs.
These are just some of the topics
discussed. Any ENA member with an
interest in EMS can sign up for NEMSAC
meeting updates at www.ems.gov. All
Office of EMS updates and NEMSAC
meeting materials are available here.
Any members with questions
may contact the author at mahastings
@seton.org.
NEMSAC Update: A Look at Community ParamedicineBy Michael Hastings, MSN, RN, CEN
Many emergency nurses are finding themselves in the ‘‘sandwich
generation.’’ If you haven’t heard this term, it describes those who are
providing health care of some sort to their own dependents as well as to an
older family member, friend or neighbor.1
While there is much in current literature about this stage in our lives, there
is not much written about what ethical and moral dilemmas arise when a
nurse finds himself or herself in the middle of conflict between what we
know is best and family members’ wishes. We all have been in the situation
where, as the nurse in the family, we are asked to facilitate health care
decisions or provide advice to our loved ones. We draw upon our nursing
expertise to counsel our families on what we think might be best for them. In
the sandwich generation, we may be increasingly called upon as we become
more involved with health care decisions for our aging parents, or even for
our siblings or close friends.
After dealing with moral and ethical dilemmas in the workplace, we find that
we are now facing similar dilemmas within our own families or circles of
friends. We find ourselves in the situation of being ‘‘double-duty caregivers,’’
meaning we care for patients in the workplace and then must continue that role
within our own families or circle of friends.2 Being identified as a health care
decision-maker seems at first to be an easy choice. We learn what the patient,
our friend or family member wants and then we implement their wishes when
the time comes. We tell ourselves, ‘‘We are the nurse — we can do this.’’
The reality is, when we are actually faced with making
an end-of-life decision for someone we love and
have cared for, it may be more emotionally taxing
than we anticipate. We intervene
with patients and families in our
jobs and then must come home
to do the same with those who
are dependent on us for health
care within our families
or friends. Fear
of making
the wrong
decision may
lead to guilt
IT’S NOT EASY IN THE MIDDLE
Applying Your Nursing Know - How to Family Can Get ComplicatedBy Vicki C. Sweet, MSN, RN, CEN, CCRN, FAEN, 2014 Chairperson, Emergency Nurses Wellness Committee
Official Magazine of the Emergency Nurses Association 31
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
and second-guessing, especially if our family/friend/
patient takes a turn for the worse. It can cause us to
doubt our identity as a nursing professional.3
It also may be a cause of moral distress, especially
when the wishes of the patient or other family
members might be contrary to what we believe to be
best.4 Moral distress is a term that has been used to
define this sense of doubt in the context of workplace
decisions; it may also be applicable in the decisions
we are asked to make for family or friends. Without
support or self-fulfillment, compassion fatigue may be
inevitable.
What resources are there for us to be able to fill
our own cups of compassion? While the topic of
compassion fatigue has been around since 1992, it is
in recent years that it has gained attention. We are
getting better at understanding the importance of
self-care and compassion satisfaction. In 2013, the
Wellness Committee published a white
paper on nurse fatigue (tinyurl.com/
nursefatigue, QR code at left) after
recognizing the effects of physical fatigue
on patient safety as well as our own quality of life.
This year, we are tackling the subject of compassion
fatigue and are finding the need for more research
in this area. A topic brief soon will be available and
will outline current progress as well as challenges for
the future.
Compassion satisfaction is a crucial component of
nurse wellness. ENA is well-positioned to address the
issue for the benefit of our members, our patients and
the entire health care community.
This article is dedicated to the memory of Christine
Dimitrakopoulos, PhD (c.), MSN, RN, CEN.
Dimitrakopoulos was appointed to the first Wellness
Committee by Benjamin E. Marett, MSN, RN, CEN, CNA,
COHN-CS, 2000 ENA president, and her ultimate goal
was to help emergency nurses care for themselves and
for one another in body, mind and spirit. She died in
October 2013, knowing ENA was carrying on her
dream.
References1. Do, E., Cohen, S., & Brown, M. (2014). Socioeconomic and demographic factors modify the association between informal caregiving and health in the sandwich generation. BMC Public Health 14, 362.
2. Ward-Griffin, C., St. Amant O., & Brown, J.B. (2011). Compassion fatigue within double duty caregiving: Nurse-daughters caring for elderly patients. Online Journal of Issues in Nursing, 16(1), 14.
3. Ward-Griffin, C. (2013). Blurred boundaries: Double duty caregiving. The Canadian Nurse, 109(6),15.
4. Fernandez-Parsons, R., Rodriguez, L., & Goyal, D. (2013). Moral distress in emergency nurses. Journal of Emergency Nursing, 39,547-552.
August 201432
On May 6-7, a record-breaking 99
ENA members attended ‘‘Day on
the Hill’’ to advocate on behalf of ENA’s federal legislative
priorities. This year’s event included sessions with senior
congressional staff and issue experts, a networking
reception, morning coffee on Capitol Hill and visits with
members of Congress.
The program began with a panel comprised of Capitol
Hill staffers J.P. Paluskiewicz, deputy chief of staff for Rep.
Michael Burgess, MD (R-Texas), and Stanley Watkins, chief
of staff for Rep. Bobby Rush (D-Ill.). These Hill veterans
explained the ins and outs of life in a congressional office
and advised ENA members on how to make the most of
their Hill visits and convince their elected officials to take
action on their requests. The experts also discussed the
importance of follow-up.
Attendees also were briefed by experts on ENA’s two
congressional ‘‘asks’’: H.R. 4080, the Trauma Care Systems
and Regionalization of Emergency Care Reauthorization Act,
and H.R. 274.S. 153, the Mental Health First Aid Act.
Lisa Tofil, who represents the Trauma Center Association of
America, explained the federal government’s role in regulating
and funding our nation’s trauma centers and systems. Tofil
kept the audience engaged as she thoroughly explained H.R.
4080 and what the trauma grants within the bill accomplish.
She gave attendees all the tools they needed to make the case
as to why our nation’s trauma care system is in dire need of
federal support. This included highlighting that 45 million
Americans live without access to a major trauma center within
the critical golden hour after a serious injury.
On the topic of mental health, ENA members heard from
Al Guida, president and CEO of Guide Consulting Services.
He represents several organizations, including the National
Mental Health Association and the National Mental Health
Awareness Campaign. Guida emphasized the importance of
recognizing mental health issues in individuals early, before
the condition develops into something more serious. This
need for early recognition was the impetus behind the
Mental Health First Aid Act, which would offer grants to
teach people how to spot signs of mental health problems
and how to offer help. Mental Health First Aid is the CPR of
mental health disorders.
May 7 kicked off with a Coffee with Congress event in
the Rayburn House Office Building on Capitol Hill. ENA
members heard from multiple members of the House of
Representatives, including Rep. Michael Burgess, MD
(R-Texas). Burgess is the lead sponsor of H.R. 4080. He
provided a status update on his legislation and thanked ENA
members for supporting his legislation and traveling to D.C.
to advocate for the bill. He entertained the audience with
ENA ADVOCACY | Ken Steinhardt, Director of Government Relations
Our In-Person Impact
ENA advocates at Day on the Hill got some motivating face time with two congresswomen with nursing backgrounds: Rep. Lois Capps (D-Calif., top photo) and Rep. Diane Black (R-Tenn., bottom photo, left, with ENA 2014 President Deena Brecher, MSN, RN, APN, ACNS-BC, CEN, CPEN).
Record ‘Day on the Hill’ Group Has Legislators Listening
Celebrate Emergency Nurses WeekTM
This year's theme is Life Saving Hands.
Emergency Nurses WeekTM
October 5 – 11, 2014
Emergency Nurses Day®
Wednesday, October 8, 2014
Here are some fun ways to celebrate: ¡ Participate in community events such as health & wellness fairs
¡ Promote team building through scavenger hunts and staff picnics
¡ Shop Marketplace for EN Week gifts to share with your colleagues!
For more ideas on EN Week activities visit www.ena.org/ENweek
Images from 2013 Emergency Nurses Week Instagram photo contest winner, Washington Regional Medical Center, Fayetteville, AR.
EN Week Ad_Connection_half_08 2014.indd 1 6/25/14 4:07 PM
Official Magazine of the Emergency Nurses Association 33
stories from his days as a practicing
obstetrician in Texas — before the existence
of emergency physicians — and said
emergency nurses were always there to
provide vital care to patients.
Burgess was followed by Rep. Lois Capps
(D-Calif.), co-chair and founder of the House
Nursing Caucus. A former school nurse, Capps
spoke about the importance of the nursing
profession and how she has dedicated much
of her congressional career to legislation
impacting all nurses. These efforts have
included legislation addressing the national
nursing shortage, improving mental health
services, providing emergency defibrillators to
local communities and bringing CPR
instruction to schools.
The final speaker of the morning was the only former
emergency nurse serving in Congress, Rep. Diane Black
(R-Tenn.). Black explained how she still has a distinct
connection to emergency nurses and showed authentic
excitement for addressing a group of emergency nurses. She
told the group how she became an emergency nurse, how
much of an impact that has had on her life and how she is
still an actively licensed registered nurse in Tennessee.
After this encouraging event, attendees met with their
members of Congress — more than 120 senators,
representatives and their staff. Based on the increase in
co-sponsors to both the trauma care and mental health bills, it
is obvious the time and effort put in by these members had an
immediate and positive impact. More important, the relation-
ships formed with the offices of senators and representatives
will pay dividends in the future as ENA members advocate on
issues critical to emergency nurses.
Texas ENA members Michael Moon, PhD, MSN, RN, CNS-CC, CEN, FAEN (left) of the ENA Board of Directors and Cam Brandt, MS, RN, CEN (right) talk about emergency nursing concerns with Rep. Joe Barton (R-Texas).
BOARD WRITES | Sally K. Snow, BSN, RN, CPEN, FAEN
ENA is very pleased to have
multiple opportunities to
collaborate on behalf of children with
our colleagues in emergency medical
services, pediatrics and emergency
medicine. It has been my honor to be
a participant in these collaborative
projects for many years. Most recently,
ENA worked with the American
Academy of Pediatrics and the
American College of Emergency
Physicians to co-author a joint policy
statement and technical report titled
‘‘Death of a Child in the Emergency
Department.’’
Last month, for the first time ever,
the Journal of Emergency Nursing,
Annals of Emergency Medicine and
Pediatrics simultaneously published
both of these collaborative documents.
Our first joint policy statement, ‘‘Care
of Children in the Emergency
Department,’’ was a groundbreaking
opportunity for emergency nursing
and emergency medicine to come
together to produce a comprehensive
plan for improving ED preparedness.
Already in the works are additional
collaborative documents addressing
patient- and family-centered care, best
practices in patient flow for pediatric
patients in the ED, and transition of
care in the ED. This important
collaboration aims to provide all
hospitals with comprehensive resources
that can establish best practices for
providing care to children in the ED.
In addition, many of you heard
from me or one of the ENA Pediatric
Committee members in 2013
requesting your participation in the
National Pediatric Readiness Project.
If you were the nurse leader in your
organization who completed the
assessment, you are aware of your
hospital’s readiness score and know
where the gaps are. Both represent
instant feedback that was part of this
comprehensive quality-improvement
project. As a staff nurse, you may not
know your hospital’s readiness score.
Make a point to ask if you are
interested.
While more than 4,100 EDs
participated in the assessment and
median readiness scores improved
from 55 in 2003 to 69 in 2013, we still
have some work to do. We must
ensure that all EDs are prepared to
care for children with the right
equipment, competent staff, necessary
policies and procedures in place, and
a quality-improvement plan that
includes pediatric patients. What we
know about readiness is that having a
designated nurse who champions
pediatric preparedness improves the
chances that a hospital is prepared.1
Hospitals should use
the gap analysis to
prioritize improving
their readiness
score. The EMS for
Children program
supports the
www.pediatricreadiness.org
website, which allows emergency
nurses to look at the recommendations
of the joint policy statement— the
basis for the NPRP assessment.
Our next step is to improve our
collaboration with EMSC state
partnership managers. These dedicated
individuals primarily have a
background in EMS or state
government and need the assistance of
emergency nurses to open doors and
facilitate dialogue. ENA members are
uniquely positioned to help bridge the
gap and enable EMSC managers to
mobilize available resources to
improve emergency preparedness. If
you don’t know your EMSC state
partnership manager, I strongly urge
you to make a point to get acquainted.
Visit tinyurl.com/
emscstate or scan the QR
code at left.
Together, ENA, EMSC
and your state chapters of ACEP and
AAP are a powerful force with the
resources to move those state and
hospital preparedness scores even
higher in the near future. Your
efforts will improve care for the
children in your communities. They
may be one-third of our population,
but they are all of our future.
Reference
1. American Academy of Pediatrics, Committee on Pediatric Emergency Medicine, American College of Emergency Physicians, & Emergency Nurses Association Pediatric Committee. (2009). Joint policy statement —Guidelines for care of children in the emergency department. Pediatrics, 124(4):1233-1243. doi:10.1542/peds.2009-1807
Join Our Collaboration on Behalf of Children
August 201434
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August 201436
FLU VACCINATIONS
‘Are you up to date on your
immunizations?” Staff nurse
Linda Ebbeler, BS, RN, CEN, working
triage in the University of Michigan’s
adult emergency department, asks the
question of any patient with possible
flu exposure during flu season.
It’s not just students and their
families. Ebbeler’s ED serves the
surrounding Ann Arbor community,
international visitors via the nearby
airport, sports fans in town for big
games and, far more than you’d
expect, groups passing through who
have religious or cultural objections to
vaccines. On the immunization
question, the latter aren’t engaged.
‘‘I am obligated to ask, and I can’t do
any more when they say no,’’ Ebbeler
said. ‘‘[I say to them], ‘You need to think
about this.’ They seem to stop listening.’’
August is National Immunization
Awareness Month, and Ebbeler is the
sort of emergency nurse who wants to
keep others from glazing over,
including fellow nurses. The Centers for
Disease Control and Prevention calls for
any healthy person age 6 months or
older to get a flu vaccine every year
— ideally as soon as they become
available, around October. ENA stands
solidly behind that recommendation.
The ENA topic brief Adult Immuni-
zations (tinyurl.com/ENAimm or QR
code at left) includes
detailed administration
guidelines for the flu vaccine
and 11 others as determined
by the CDC’s Advisory Committee on
Immunization Practices. All are evidence-
based and reviewed annually.
Some of Ebbeler’s triage patients
will have gotten their flu vaccines. She
said a similar number who aren’t
vaccinated aren’t so much resistant as
uninformed about why vaccines are
needed and where to get them.
‘‘The partially informed are just my
challenge,’’ Ebbeler said. ‘‘I don’t
understand it. I understand that factually
and objectively, that’s your choice, but
you’re affecting everybody else.’’
It works like this: Exposure to a
disease or getting a vaccine with a
dead or weakened version of virus
(imitating a full-blown infection)
triggers the body to create antibodies
to ward off the disease in the future
— the natural immune response that
can come with normal, minor
symptoms such as fever. The higher
the public vaccination rate for a
disease, the less likely that those who
aren’t or can’t be vaccinated will be
exposed (‘‘herd immunity’’).
History is clear on flu as a killer,
with the 1918-1919 ‘‘Spanish Flu’’
standing as the grimmest example.
Between 20 and 40 million people
around the world died in that
pandemic, including 675,000 in the
United States, which lost only a tenth
of that number in World War I.
The etiological cause of flu was
pinpointed in 1933, with vaccinations
beginning in the 1940s. Seventy-plus
SETTING THE MISCONCEPTIONS STRAIGHT• I can’t get a flu vaccine. I hate needles.Flu vaccines can also be given intranasally and transdermally.
• The flu shot will give me the flu.The flu in vaccines is weakened or inactivated, is not infectious and cannot cause flu. There can be mild side effects, including low fever, headache and tenderness where a shot was given.
• You’re better off getting the actual flu than getting the vaccine.Flu is a serious illness that can mean hospitalization or death for healthy adults and children. Those under age 2 or older than 65 or with existing health complications are especially at risk.
• The flu vaccine doesn’t work because you can get the flu anyway.Each year’s vaccine is tailored to three or four strains of flu that experts expect to circulate. It is possible to get a very different strain outside the protection of the vaccine, or to come down with flu you were exposed to before getting the vaccine or while you were still building immunity. Respiratory viruses with flu-like symptoms also can be mistaken for the flu. Source: CDC
By Josh Gaby, ENA Connection
BEST SHOT AT SAFETY
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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Official Magazine of the Emergency Nurses Association 37
years later, vaccinations are well below
what they ought to be, according to the
CDC, which received reports of 9,632
lab-confirmed flu hospitalizations
between Oct. 1, 2013, and May 17,
2014, including an increase among
patients ages 18-64 and more than 90
pediatric deaths (flu-related death
reporting is not required for patients
older than 18). Not getting vaccinated
is a real threat to health care workers
and those they come in contact with,
said Monica Escalante, MSN, RN, senior
associate for the ENA Institute of
Quality Safety and Injury Prevention.
‘‘If you are caring for someone
who’s immunocompromised and you
choose not to get vaccinated, you are
putting that patient at risk,’’ Escalante
said. ‘‘Influenza can be spread in the
24 hours before symptoms develop to
5-7 days after actual symptoms begin.’’
Consider these case studies
provided by the ENA Institute for
Emergency Nursing Research:
♦ Hank, a long-distance truck driver
two days from home, presented to the
ED complaining of a cough with
blood-tinged sputum, myalgias and
fever. He gave a medical history
significant for diabetes mellitus type 2
and asthma. He reported he hadn’t felt
well before leaving home, and his
fever now felt higher. The triage nurse
obtained the following vital signs: oral
temperature of 104.2 F, respiratory rate
of 40, SaO2 of 85 percent, blood
pressure of 85/40 and a heart rate of
125. Hank was immediately brought to
a treatment room, where he was
intubated and placed on mechanical
ventilation. Chest radiography showed
bilateral infiltrates. His dropping blood
pressure required the use of
vasopressors, and he was moved to
the intensive care unit. Despite
aggressive therapy, he died 48 hours
later. A viral culture was positive for
Influenza A; his wife noted he had not
received an influenza vaccine.
♦ Mallory, a 7-year-old with cerebral
palsy, was sent home from her public
school because of a fever and sore
throat. By evening, her temperature
was 102.0 F and she was having
prolonged coughing episodes. Her
mother gave her fluids and cold
medicine and planned to take her to
her pediatrician in the morning. By
morning, Mallory was experiencing
shaking chills, clammy skin and
prolonged coughing episodes, during
which she could not take a deep
breath. She became less responsive,
and her mother decided to bypass the
pediatrician’s office and take her to the
ED. Chest radiography showed bilateral
pneumonia; her rapid antigen test was
positive for Influenza A. Despite
aggressive treatment, Mallory was in
respiratory arrest and could not be
resuscitated. Her mother had not
vaccinated Mallory against influenza.
Continued on next page
August 201438
COMMITTEES AND WORK TEAMS
ENA has several national
committees and work
teams comprised of skilled
and dedicated members eager
to share their expertise with
the membership. One very
productive group has been
the Emergency Nursing
Technology and Informatics
Work Team, whose members
have produced a position
statement, a topic brief and a
handbook in less than three
years.
Chairperson Michael
Seaver, BA, RN, an ENA
lifetime member, said he
jumped at the chance to
chair the work team in 2012
after a few years as facilitator
of the ED Informatics Special
Interest Group.
While the work team had
a number of charges in the
beginning, Seaver said the
members — some who have rotated off the work team since 2012 — chose to
focus on technology issues related to emergency nursing practice. The team’s
biggest undertaking was writing a book on electronic medical record
implementation, which fulfilled its charge of developing key performance indicators
for an evaluation of clinical systems and technology application, Seaver said.
‘‘That, to me, was the highlight of our whole time,’’ he said. ‘‘We took our
combined various knowledge and expertise and tried to put all of that in an
organized fashion to provide the membership with some guidance . . . when they
were implementing an electronic medical records system, whether it be standalone
or part of an integrated enterprise.’’
The work team also developed one of ENA’s first topic briefs in 2012,
‘‘Health Information Technology in the Emergency Department’’
(tinyurl.com/ENAedtech or QR code at left). Seaver said the goal in
creating it was to provide members easily accessible educational material.
‘‘For a lot of people, EMRs are a lot of computer stuff, a lot of acronyms, a lot of
things that people have to learn to work with, but maybe they don’t understand all
Meet the Team That Took on ED Technology
Flu Vaccinations Continued from previous page
By Amy Carpenter Aquino, ENA Connection
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.
For an ENA member committed
to safe practice, safe care, flu is a
glaring patient hazard. Briana Quinn,
MPH, BSN, RN, senior associate for
wellness and injury prevention for
IQSIP, said the best approach is to
consider the flu vaccine a necessary
medication, with rare adverse effects
like any other medication.
‘‘The myths about vaccinations
are just rampant,’’ Quinn said. ‘‘You
cannot get the flu from a flu shot. If
you do get a slight fever after the flu
shot or feel crummy after it, that’s
expected because it means your
immune system is reacting
appropriately. It takes your immune
system approximately two weeks
after a vaccination for antibodies to
develop with protective effects. If
you come down with the flu in that
two-week period, it was not from
the flu shot — it probably was
because you already had a virus and
you didn’t have the immunity.’’
Do your homework and rely on
the CDC evidence, Quinn said.
Back in Ann Arbor, Ebbeler
continues sounding the horn.
Pamphlets and fliers are a conduit to
consider, she said. So is the idea of
embedding the immunization
question in discharge paperwork.
‘‘My response to ‘How do you
deal with the public and the
pushback?’ is exactly how it’s been
done: a constant barrage of
encouragement,’’ Ebbeler said.
‘‘ ‘These are the 24-hour places you
can get it,’ with the free accessibility,
the community programs if there’s
funding for it. That’s the only way I
see it being tackled.’’
Resources
Misconceptions About Seasonal Flu and Flu Vaccines, CDC.gov
Situation Update: Summary of Weekly FluView, www.cdc.gov/flu/weekly/summary.htm
The Influenza Pandemic of 1918, virus.stanford.edu/uda/
Understanding How Vaccines Work, CDC.gov.
Official Magazine of the Emergency Nurses Association 39
T he 2014 ENA
Annual
Conference in
October will be
particularly special as
both Emergency
Nurses Week and Emergency Nurses
Day occur during conference this
year. We will have daily activities to
celebrate with our attendees and
emergency nurses worldwide.
This presents a wonderfully
unique opportunity for ENA’s social
media channels. Last year, we asked
members to use Instagram to submit
entries for this year’s Emergency
Nurses Week poster. This year, we
will use social media to help connect
all members to our celebration, so
that even if you aren’t able to join us
in Indianapolis Oct. 7-11, you can
still be a part of the Annual
Conference fun.
Look for more exciting
announcements as the time for
conference draws near. Join the
conversation using the hashtag
#ENWeek, whether you are on-site or
elsewhere. If you are attending, stop
by @ENA Wired to get the latest
information on activities for the week.
We look forward to celebrating
with you!
ENA CONNECTED
Annual Conference, Emergency Nurses Week Sync UpBy Thomas Barbee, ENA Digital Marking Manager
the implications,’’ he said. ‘‘So this was a unique opportunity
to be able to put that together for the membership.’’
A position statement, Mobile Electronic Device
Use in the Emergency Department (tinyurl.com/
ENAedmobile or QR code at left) was approved
by the ENA Board of Directors in September 2013.
In the position statement, the work group outlined ENA’s
support for emergency nurses’ access to mobile devices,
partially as a matter of patient safety. A mobile device
provides instant access to the Internet for evidence-based
clinical information, drug references, best practices and more.
The work team tackled the issue of social media in the
ED by presenting a concurrent session titled ‘‘The Good, the
Bad and the Ugly: Social Media and Social Networking’’ at
the 2013 ENA Annual Conference in Nashville, Tenn. 2013
ENA President JoAnn Lazarus, MSN, RN, CEN, suggested the
topic, which intrigued the rest of the work team.
‘‘It was something we had never considered,’’ said Seaver,
one of four work team members who presented the session.
‘‘We covered a lot of the do’s and don’ts and cautions, as
well as some of the very positive aspects of using social
networking and social media. I think we probably took a bit
more of a precautionary stance, just because the potential for
not-so-good things happening is very high, and the
consequences of those not-so-good things.’’
The work team has been investigating several other topics,
including wrong-chart documentation, work-arounds and
workstation security. Alert fatigue was of particular interest to
Deb Esse, MHA, BS, RN, CEN, who joined the team in January.
‘‘Technology affects everyday practice because we are
documenting electronically now and we are getting more
dependent upon the electronic documentation and alerts,’’
Esse said.
Alert fatigue arises when clinicians grow immune to the
constant alerts that pop up on their computer screens when
they are documenting in an EMR and they choose to bypass
the alerts without reading them. A recent study on drug
alerts showed that more than 50 percent of drug alerts were
bypassed, and the majority of those were for possible
allergies or drug interactions, Esse said.
‘‘What the literature suggests is that we look at the
amount of alerts that we are putting up and only put up the
most necessary ones,’’ she said. ‘‘Otherwise it just becomes
white noise.’’
The other related issue the work team is exploring is
alert overdependence, which occurs when clinicians wait for
an alert to send a cue that a mistake was being made
without thinking independently.
‘‘It’s a huge safety issue,’’ Esse said.
Esse said she joined the work team after working for
years as an ED staff nurse and then in her current position
with a technology company, where she helps implement
coding software for EDs and helps clients use collected data
to make improvements.
‘‘It just made sense for me to join this, because I have
experience with every kind of electronic health record . . . .
I’m aware of the different styles and different types of
documentation, and it fascinates me,’’ she said. She said her
experience so far on the work team has been ‘‘really fun.
They’re a great group of people, really knowledgeable.’’
The work team is being sunsetted at the end of this year,
with the ED Operations Committee absorbing its purpose.
Seaver said the conclusion of the work team’s composition
is bittersweet, but members are proud of their work and the
resources they’ve created for the membership.
When he was invited to be the chairperson, Seaver said,
he was thrilled at the opportunity to collaborate with talented
work team members and ENA staff.
‘‘We had the pleasure of working with a number of staff
members, and it has always been an absolute delight,’’ said
Seaver, who wished to send ‘‘a big thank-you to everybody
involved with the work team.’’
Joanne Fadale, BSN, RN, FAEN, the 1990 ENA president,
remembers how much ENA meant to co-founder Anita
Dorr. Fadale worked for Dorr, RN, FAEN, at the Edward J.
Meyer Hospital in Buffalo, N.Y., from 1970 to 1972 and
witnessed how Dorr encouraged every nurse in the
emergency department to join the association.
‘‘She told me you had to belong to the association to work
in the emergency department. She really believed in it, and so
did I, as well as everyone else who joined,’’ Fadale said.
Dorr and co-founder Judith C. Kelleher, MSN, RN, CEN,
formed the Emergency Department Nurses Association in
1970 and selected the roadrunner to be EDNA’s mascot. Dorr
designed the original pin featuring a roadrunner with a
nurse’s cap (see photos). During her visit to ENA headquarters in May, Fadale recalled the significance of
the roadrunner symbol and what it meant to Dorr and
Kelleher.
‘‘The roadrunner is a bird that doesn’t stop,’’ she said
while holding an EDNA T-shirt with the roadrunner symbol.
‘‘It goes after what it needs to do, fixes it and continues.
That’s why they chose it as their logo. They thought
emergency nurses were like roadrunners because they
persist and do what they need to do. It was developed
because they really thought roadrunners were tenacious and
represented what emergency nurses did.’’
‘‘The Roadrunner’’ also was the name of EDNA’s first
newsletter. The mascot was used until the late 1970s.
As ENA’s volunteer historian, Fadale understands the
importance of preserving ENA’s history, especially because
she has been involved in ENA since its formation. During
her visit, she met with the ENA staff archivist to continue the
work of the Historical Perspectives Work Team, which was
active from 2011 through 2013.
Fadale will work with the staff archivist on developing a
sustainable system to retain important ENA documents and
other historical materials in the appropriate ENA or
ENA-affiliated repositories.
To learn more about the roadrunner and ENA’s
early history, documents are now available for viewing
online at the University of Virginia School of Nursing,
Eleanor Crowder Bjoring Center for Nursing Historical
Inquiry. A link to the ENA Collection is accessible from
ENA’s History page, www.ena.org/about.
August 201440
ENA ARCHIVES
Remembering the Roadrunner
CelebrateEmergency Nurses Week™
October 5 – 11, 2014
Shop Marketplace Gifts for You and Your Staff
Order by 9/22 for EN Week delivery Visit www.ena.org/shop
To get free shipping through 10/10, type “ENWEEK” in the comment box of your online order. Restrictions may apply.
ENA Marketplace Ad_Connection_qtr_08 2014.indd 1 7/10/2014 10:48:41 AM
By Kendra Y. Mims, ENA Connection
Joanne Fadale, BSN, RN, FAEN, displays T-shirts and a pin depicting ENA’s early mascot, the roadrunner.
§Attend a wide range of educational sessions covering 9 key practice areas
§Earn over 25.5 contact hours, depending on sessions attended
§Learn about innovative products and services
§Network with colleagues from around the world
REGISTER BY AUGUST 14 AND SAVE For the latest updates, visit www.ena.org/AC
Follow the action on #ENAAC14
The Emergency Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
REGISTER NOW
INDIANAPOLIS Indiana Convention Center October 7-11, 2014
AC14_Connection_full_08 2014.indd 1 6/25/14 3:39 PM
August 201442
PRACTICE INNOVATIONS
Providing care to patients who speak a language other
than English or who are hearing-impaired can be
difficult in the best of circumstances. Add the urgency of
providing care in an emergency department, and barriers
due to language differences can be frustrating for both
patient and caregiver.
ENA member Michelle Parish, RN, recalled how the
previous interpretation systems used at her ED at Saline
Memorial Hospital in Benton, Ark., did not allow nurses to
provide the most efficient patient care for the hearing-
impaired or those who spoke another language. The ED
used a telephone interpreter service when caring for patients
who spoke another language and had to call in an
interpreter for the hearing-impaired.
‘‘With the prior methods, there was a delay in patient care
for our hearing-impaired,’’ she said. ‘‘We had to wait for
somebody to come in and provide the interpretation.’’
If there was no time to wait, ED staff had to rely on
communicating by pointing to body parts to indicate they
had to draw blood, for example.
‘‘We were doing the best communication we could do
with the patient,’’ Parish said.
Even the phone interpretation system method was
lacking, since it was impossible for the interpreter to pick up
on patients’ body language, she said.
‘‘You’re just limited to what information you could gather
through a phone call, and so it was hard to tell if there was
understanding of what the discharge instructions were or
anything like that,’’ she said.
For more complicated cases, such as when a patient had
to go into surgery, the ED had to call in an interpreter.
Parish’s experiences are in line with the findings from a
2012 study by Elizabeth A. Jacobs, Paul C. Fu Jr. and Paul J.
Rathouz, ‘‘Does a Video-Interpreting Network Improve
Delivery of Care in the Emergency Department?’’ The authors
said face-to-face interpretation is useful ‘‘but inefficient
because time interpreting is lost in transit between clinical
sites and waiting for providers and patients. Telephonic
interpretation increases efficiency of service delivery, but it
has the disadvantage of loss of interpreter visual clues and
rapport development with patient and provider.’’
Six months ago, Saline Memorial adopted a video
interpretation system for non-English-speaking and hearing-
impaired patients. The results have been better communication,
less stress and more timely delivery of care, Parish said.
The system works via an iPad. A nurse taps an icon to
choose either a language interpretation service or a hearing-
impaired interpretation service. There are about 30 languages
available, and more are added each year.
In 20 to 30 seconds, an interpreter is visible on the iPad
screen and can begin communication with the patient while
the nurse holds the iPad.
‘‘It’s very simple, very easy, and there is no delay in care,’’
Parish said. ‘‘[Patients are] able to communicate through the
person on the iPad what their presenting problem is,
associated symptoms and all the medical questions that we
need to know to provide better care for the patient. We’re
able to communicate back to them what we’re going to do,
why we’re doing it, what the physician recommends.’’
‘‘I think it’s a great technology,” she added. ‘‘It’s certainly
helped us break down that communication barrier, being
more effective in the way we’re able to deliver care for those
patients.’’
Laura Gotcher, RN, an ED team leader at Saline Memorial Hospital in Benton, Ark., demonstrates the facility’s video interpretation system with staff nurse Dianne Koopmann, RN.
COMING TO A SCREEN NEAR YOU?Video Interpretation System Means Faster Care for Those With BarriersBy Amy Carpenter Aquino, ENA Connection
Ph
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43
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Official Magazine of the Emergency Nurses Association
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