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August 2014 Volume 38, Issue 7 the Official Magazine of the Emergency Nurses Association c o n n e ct i o n COMMON 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

ENA Connection August 2014

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Page 1: ENA Connection August 2014

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

Page 2: ENA Connection August 2014

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

Page 3: ENA Connection August 2014

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

Page 4: ENA Connection August 2014

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

Page 5: ENA Connection August 2014

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].

Page 6: ENA Connection August 2014

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

Page 7: ENA Connection August 2014

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

Page 8: ENA Connection August 2014

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

to [email protected].

Call for Memorial Requests at 2014 ENA General Assembly

From the President Continued from Page 3

Page 9: ENA Connection August 2014

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

Page 10: ENA Connection August 2014

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

Page 11: ENA Connection August 2014

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

Page 12: ENA Connection August 2014

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

Page 13: ENA Connection August 2014

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.

Page 14: ENA Connection August 2014

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

Page 15: ENA Connection August 2014

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

Page 16: ENA Connection August 2014

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

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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.

Page 17: ENA Connection August 2014

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.

Page 18: ENA Connection August 2014

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

Page 19: ENA Connection August 2014

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

Page 20: ENA Connection August 2014

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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

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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”

Page 21: ENA Connection August 2014

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”

Page 22: ENA Connection August 2014

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”

Page 23: ENA Connection August 2014

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

Page 26: ENA Connection August 2014

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

Page 27: ENA Connection August 2014

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

Page 28: ENA Connection August 2014

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

Page 29: ENA Connection August 2014

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.

Page 30: ENA Connection August 2014

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

Page 31: ENA Connection August 2014

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.

Page 32: ENA Connection August 2014

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

Page 33: ENA Connection August 2014

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).

Page 34: ENA Connection August 2014

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

Page 35: ENA Connection August 2014

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Page 36: ENA Connection August 2014

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

Page 37: ENA Connection August 2014

Updated Teaching

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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

Page 38: ENA Connection August 2014

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.

Page 39: ENA Connection August 2014

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.’’

Page 40: ENA Connection August 2014

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.

Page 41: ENA Connection August 2014

§Attend a wide range of educational sessions covering 9 key practice areas

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§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

Page 42: ENA Connection August 2014

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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Page 43: ENA Connection August 2014

43

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Official Magazine of the Emergency Nurses Association

Page 44: ENA Connection August 2014

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