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CORRECT
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CA
AR
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E
TM
A Publication of the National Commission on Correctional Health Care
Summer 2007 • Volume 21, Issue 3
Homegrown Human Capital
Dental Treatment
One Facility’s Response to Its Nursing Shortage
inspector, I was familiar with longterm care regulations and the nurse
aide training programs in nursing
ike many states, Missouri is expehomes certified by the Centers for
riencing a significant shortage of
Medicare and Medicaid and licensed
registered nurses. This shortage
by the Missouri Department of Health
is felt in every health care facility,
and Senior Services. I applied the same
public and private alike. Still, it is no
concept to SLPRC, with some modifisecret that many state-operated facilications. This is the first
ties have shortages far worse
program of its kind to
than in the private sector.
be offered in a Missouri
Despite the stability of state
mental health facility.
employment and abundant
To set up the probenefits, these facilities can’t
gram, I attended a twocompete in terms of wages and
day seminar to become
resources, not to mention
a qualified instructor
extravagant lures such as large
and examiner. I then
sign-on bonuses, total tuition
made application and
or loan reimbursements and
received permission
other incentives.
from the Department of
However, one state facility
Health and Senior
has developed a homegrown
Services for SLPRC to
solution that not only helps the Hands-On. The author teaches psychiatric aides how to measure heart
become an on-site
nurses during this critical time rate during the CNA training. (L-R: Gwen Boyd, Vanessa Short, Barbara
training agency.
but also invests in its workforce Shirrell, Freda Green, Sunday Martin and Susan Turner)
Other expenses were
by upgrading the skills necesmoderate and included training
oversight either due to their mental
sary to meet the challenging care
tapes, manuals and a manikin. Each
impairment alone or in combination
needs of the clients. This approach
CNA candidate paid the $50 exam fee.
with their physical care needs.
could help other state facilities deal
The CNA training consists of a 16with their own nursing shortages.
Evolution of a Solution
hour orientation module with emphaRising Need for Skilled Care
sis on the needs of geriatric patients
Faced with this changing psychiatric
—including emergency care, infecclient profile, the growing demand for
The St. Louis Psychiatric Rehabilitation control and prevention of abuse
nursing care and fewer nurses due to
tion Center is a 212-bed inpatient
and neglect—and 100 hours of onattrition, SLPRC had to find a way to
facility operated by the Missouri
the-job training in basic nursing. The
meet these challenges without an
Department of Mental Health. SLPRC
basic nursing skills include vital signs,
influx of new financial resources.
treats adults with severe mental illsigns and symptoms of hyper- and
Recognizing that employees are our
nesses. About 80% of our clients
hypoglycemia, ambulation, range of
greatest asset, we assessed our
come from the criminal justice sysmotion, normal signs of aging, inconhuman capital and tapped into it.
tem and were involuntarily committinence care, nutrition, food sanitaThe psychiatric aides are an invaluted by the court system. (See page 20
tion, promotion of self-care and basic
able resource. These paraprofessionto learn more about SLPRC.)
anatomy and physiology.
als outnumber the nursing staff by
As the average age of our clients
The psychiatric aides also are eduroughly 4 to 1, and in many instances
has increased, along with the severity
cated on mentoring, leadership, team
they interact directly with the clients
of their mental illnesses and medical
building, effective communication,
the most. However, they were in need
diagnoses, so too have their needs for
conflict resolution and basic psychiof an opportunity to upgrade their
assistance with activities of daily living
atric forensic nursing (including subskills.
(bathing, grooming, feeding, etc.).
stance abuse awareness and suicide
So in 2005, we launched a certified
Some of the nurses said that SLPRC
nurse aide program for the psychiis beginning to look like a nursing
atric aides. As a former nursing home
home, with the advent of indwelling
Continued on page 20
BY GWEN BOYD, BSN, MA, CCHP
L
urinary catheters, a gastrotomy tube,
tracheostomy care and periodic use of
canes, walkers and wheelchairs.
In fact, between 2000 and 2006,
about 42% of the clients were discharged to a residential care facility
and 12% went to a skilled nursing
facility. This shows a clear need for
Non-Profit Org.
US Postage
PAID
Chicago, IL 60611
Permit No. 741
I
N S I D E
T
Some medical conditions make it
risky to provide oral care, page 8
Heads Up on New Health
Assessment Standard
Managing inmate health care is
fraught with difficulty. NCCHC understands that better than anyone. That’s
why we are pleased to announce an
important change to our Standards
for Health Services that will transform
health assessment in prisons and jails.
To be unveiled at the National
Conference on Correctional Health
Care, this forward thinking change
permits greater flexibility in health
care delivery. The likely consequences
are many: better staffing and care,
improved patient outcomes, fewer
legal risks and potential cost savings.
For over 30 years, NCCHC has led
the movement to improve correctional
health care, setting national standards
that enable facilities of all types to
provide constitutionally acceptable
care. These standards are endorsed by
the medical community and accepted
in the courts.
Having guided thousands of facilities of all types and sizes, we are the
world’s leading authority on correctional health care. At the same time,
we work with our supporting organizations and other leading professional
health care associations, and keep
close tabs on community practices to
ensure that our correctional health
care standards are clinically sound
and state-of-the-art.
The forthcoming new standards will
be reviewed at the National Conference during the preconference seminars on Saturday and a concurrent
session on Wednesday. The meeting
takes place Oct. 13-17 in Nashville.
See the back page for more information, or visit www.ncchc.org.
We look forward to giving you steadfast support throughout the process
of transitioning to the new standards.
H I S
I
S S U E
FEATURES
DEPARTMENTS
Privacy of Inmate Medical Records Still Not Clear .7
Dental Care for Medically Compromised Patients . .8
Staff Health Fair Celebrates Quality Improvement .10
Hand Hygiene: Lessons From the OR . . . . . . . . . .12
Telemedicine for Primary Care Proves Its Worth .14
Treating ADHD Vital in Incarcerated Youth . . . . . .17
Journal Preview: Correctional Physician Empathy 19
National Conference Preview . . . . . . . . . . . . . . . .24
NCCHC News: Board Updates and more . . . . . . . .2
Guest Editorial: Fiscal Self-Defense . . . . . . . . . . . .3
Letters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
CCHP News: Kelly Robinson-Bethea . . . . . . . . . . .4
Academy News: Conference Events . . . . . . . . . . .6
In the News . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Standards Q&A . . . . . . . . . . . . . . . . . . . . . . . . . .21
Classified Advertising . . . . . . . . . . . . . . . . . . . . . .23
CORRECT
NCCHC News
TM
CARE
A Publication of the National Commission on Correctional Health Care
Summer 2007
Did Somebody Say Redesign ?
You spoke, we’re listening. As
reported in the last issue, our
reader survey gave CORRECTCARE a
big thumbs up ... except for that
clumsy old tabloid format. So
we’ve recruited some creative
geniuses to give us a new look
and, best of all, a trimmed down
size. Stay tuned!
Public Health Agencies
Join the Accreditation
Bandwagon
A new nonprofit organization will
administer a voluntary national
accreditation program for state and
local public health departments. The
Public Health Accreditation Board is
the initiative of NCCHC two supporting organizations—the American
Public Health Association and the
National Association of County and
City Health Officials—along with the
Association of State and Territorial
Health Officials and the National
Association of Local Boards of Health.
According to PHAB, the reasons
for offering accreditation are simple:
accountability and quality improvement. The program is meant to:
• Promote high performance and
continuous quality improvement
• Recognize high performers that
meet nationally accepted standards
• Clarify the public’s expectations
of state and local health departments
• Increase the visibility and public
awareness of governmental public
health, leading to greater public
trust, increased health department
credibility and accountability, and a
stronger constituency for public
health funding and infrastructure
Learn more at www.phaboard.org.
Calendar
October 13-17
National Conference on Correctional Health
Care, Nashville, TN
October 14
CCHP examination, Nashville, TN
November 9
Accreditation committee meetings: Health
Services and Opioid Treatment Programs
February 23, 2008
CCHP examination, multiple regional sites
(see www.ncchc.org/cchp for details)
May 17-20, 2008
Updates in Correctional Health Care,
San Antonio, TX
May 18, 2008
CCHP examination, San Antonio, TX
October 18-22, 2008
National Conference on Correctional Health
Care, Chicago, IL
2 SUMMER 2007 • CorrectCare
Board Member Update
NCCHC welcomes the following three new members to its board of directors.
• Patricia Blair, PhD, LLM, JD, MSN, is the representative of the
American Bar Association. She is a health law attorney in private
practice and an adjunct associate professor at the University of
Texas at Tyler.
• Robert Gogats, MA, is the representative of the National
Association of County and City Health Officials. He serves as the
health officer for the Burlington County Health Department,
Westampton, NJ.
BOARD OF DIRECTORS
Robert E. Morris, MD (Chair-Elect)
Society for Adolescent Medicine
Nancy B. White, LPC (Immediate Past Chair)
American Counseling Association
Blair
Thomas J. Fagan, PhD (Secretary)
American Psychological Association
Kenneth J. Kuipers, PhD (Treasurer)
Member at Large
Edward A. Harrison, CCHP (President)
National Commission on Correctional Health Care
Carl C. Bell, MD, CCHP
National Medical Association
Patricia Blair, JD
American Bar Association
In other board news...
• Kleanthe Caruso, MSN, CCHP, was elected to the board of
directors of the Texas Nurses Association. Caruso is vice president for patient care operations and chief nursing officer at the
University of Texas Health Center at Tyler. She represents the
American Nurses Association on the NCCHC board.
C ORRECT C ARE ™ is published quarterly by the National
Commission on Correctional Health Care, a not-for-profit
organization whose mission is to improve the quality of health
care in our nation’s jails, prisons and juvenile confinement
facilities. NCCHC is supported by 38 leading national organizations representing the fields of health, law and corrections.
George J. Pramstaller, DO, CCHP (Chair)
American Osteopathic Association
• Ronald Wiborg, MA, MBA, is the representative of the National
Association of Counties. He is the contracts and grants manager
for the Hennepin County Department of Community
Corrections, Minneapolis, MN.
• Carl Bell, MD, CCHP, moderated a Capitol Hill briefing in
honor of National Children’s Mental Health Awareness Day. A
coalition of national mental health, counseling and education
organizations attended. Bell is executive director of the
Community Mental Health Council, Chicago, and represents the
National Medical Association on NCCHC’s board.
Vol. 21 No. 3
Kleanthe Caruso, MSN, CCHP
American Nurses Association
Gogats
Robert Cohen, MD
American Public Health Association
Hon. Richard A. Devine, JD
National District Attorneys Association
Nina Dozoretz, RHIA, CCHP
American Health Information Management Association
Charles A. Fasano
John Howard Association
Kevin Fiscella, MD
American Society of Addiction Medicine
Robert J. Gogats, MA
National Association of County & City Health Officials
Caruso
• Douglas Mack, MD, CCHP, attended the American Medical Association House
of Delegates meeting on behalf of NCCHC. Now “retired” in Colorado, he represents the American Association of Public Health Physicians. He also recently
completed a 300-mile “Ride the Rockies”biking event.
Let Your Mouse Do the Walking
Robert L. Hilton, RPh, CCHP
American Pharmacists Association
Renee Kanan, MD
American College of Physicians
Donald Kern, MD, CCHP
American College of Preventive Medicine
JoRene Kerns, BSN, CCHP
American Correctional Health Services Association
Daniel Lorber, MD
American Diabetes Association
Douglas A. Mack, MD, CCHP
American Association of Public Health Physicians
Edwin I. Megargee, PhD, CCHP
American Association for Correctional and Forensic Psychology
NCCHC Launches Online Correctional Health Care Buyers Guide
Charles A. Meyer, Jr., MD
American Academy of Psychiatry & the Law
If you source or purchase products for your department, you now have a
powerful tool at your fingertips. The NCCHC Buyers Guide is a search
engine that continually indexes the Web sites of all companies represented
in the directory. Visitors can easily locate products and services unique to
this field without the clutter of a general Internet search. The Buyers Guide
gives you the option of performing a keyword-driven search that mirrors traditional search engines, or a category-specific search. Both methods produce the most relevant results on the Web. With the downloadable desktop
search application, you can search for products and services from a small
window on your desktop, making the process both convenient and time-efficient. The Buyers Guide also includes a Request for Proposal (RFP) tool
that enables you to contact a group of suppliers with one click of a button.
Eugene A. Migliaccio, DrPH
American College of Healthcare Executives
Ronald C. Moomaw, DO
American College of Neuropsychiatrists
Peter C. Ober, PA-C, CCHP
American Academy of Physician Assistants
Joseph V. Penn, MD, CCHP
American Academy of Child & Adolescent Psychiatry
Peter E. Perroncello, CJM
American Jail Association
Patricia N. Reams, MD, CCHP
American Academy of Pediatrics
Judith Robbins, LCSW, CCHP
National Association of Social Workers
Sheriff B.J. Roberts
National Sheriffs’ Association
William J. Rold, JD, CCHP-A
Member at Large
New Books in the NCCHC Catalog
David W. Roush, PhD
National Juvenile Detention Association
Bates’ Pocket Guide to Physical Examination and History Taking. This handy
book presents the classic Bates approach in a quick-reference outline format,
with easy-to-understand exam techniques, abnormalities and interpretations,
and over 500 color images. This edition gives greater emphasis to patient communication and interview techniques, and has a new chapter on older adults. A
CD-ROM has a PDA download with outlines of exam procedures and techniques.
LWW (2005). Softcover, 416 pages, $39.95
Jayne Russell, MEd, CCHP-A
Academy of Correctional Health Professionals
Clinical Guide: Wound Care. This all-in-one portable guide gives detailed
guidelines on wound care and prevention strategies, and related professional
and legal issues. It features profiles and photos of over 300 wound care dressings and products, with charts of over 200 additional products. Appendices
include assessment tools and treatment algorithms. A manufacturer guide lists
Web sites and contact information plus educational programs. LWW (2004).
Spiral-bound softcover, 544 pages, $39.95
Ronald Wiborg, MBA
National Association of Counties
Rosen and Barkin’s 5-Minute Emergency Medicine Consult. This best-selling
reference is thoroughly updated with practical information on over 600 clinical
problems, including current information on emerging infections, new protocols
and new treatments. Coverage includes clinical presentation, prehospital, diagnosis, treatment, disposition and more. The fast-access two-page outline format is perfect for on-the-spot consultation, and icons make it easy to quickly
spot the information you need. LWW (2006). Hardcover, 1,336 pages, $84.95
Ronald M. Shansky, MD
Society of Correctional Physicians
Alvin J. Thompson, MD
American Medical Association
Barbara A. Wakeen, RD
American Dietetic Association
Henry C. Weinstein, MD
American Psychiatric Association
Board representatives pending:
American College of Emergency Physicians
American Dental Association
Copyright 2007 National Commission on Correctional Health Care.
Statements of fact and opinion are the responsibility of the authors
alone and do not necessarily reflect the opinions of this publication,
NCCHC or its supporting organizations. NCCHC assumes no
responsibility for products or services advertised. We invite letters
of support or criticism or correction of facts, which will be printed
as space allows. Articles without designated authorship may be
reprinted in whole or in part provided attribution is given to NCCHC.
Send correspondence to Jaime Shimkus, editor,
NCCHC, 1145 W. Diversey Parkway, Chicago, IL 60614.
Phone: 773-880-1460. Fax: 773-880-2424.
E-mail: [email protected]. Web: www.ncchc.org.
www.ncchc.org
Guest Editorial
Improve Perceptions, and Budgets, Via Fiscal Self-Defense
BY ROBERT BRADFORD, MHA
ver the years, I have come to
believe that the default public
perception about the cost of
inmate health care
is something like
this: (1) Inmates
get too much
health care, more
than free world
people, and (2) It
costs too much.
I’m not exactly
sure why this perception is so pervasive; but it is
consistent. It’s as
if there is a script lying around somewhere. There are a lot of misconceptions about corrections in general so
you may be tempted to dismiss it,
assuming it is one of those things
people choose to believe and probably benign.
However, since the cost of delivering health care is soaring for every
managed care organization—in both
corrections and the free world—this
perception works against all of us in
corrections when it comes to obtain-
O
ing needed funding. Time and again I
have seen requests for funding dismissed by fiscal authorities or legislators with little or no consideration
of the real costs of providing care.
Get the Message Out
I am convinced that we in this industry have not done enough to educate
legislators, county commissioners,
and state and county fiscal authorities
of the job that we have to do and
what it really costs to do it. Here in
Georgia, we are working with our
partners in the Department of
Corrections to do this educatation
and exercise some “fiscal selfdefense” for correctional health.
First, we looked at how our costs
compared to other entities in the
managed care industry. We found
that our costs were not only comparable, but also often significantly less
per capita than entities such as
Medicaid and HMOs. Also, we are
finding that our system is often
ahead of other insurers in terms of
utilization management, preventive
care and drug formulary management. I don’t mean to cast aspersions on any other provider (they
Exciting Career Opportunity
Director of Accreditation
This key leadership position within NCCHC reports directly to the
President, serves as a member of his executive management
team and interacts with key committees of the Board of Directors.
The Director of Accreditation is responsible for developing standards and performance measures for health care delivery in a
variety of institutional settings. The position also trains, supports
and manages effective staff and contractor teams. The individual
must not only understand and help to shape organizational
vision and strategy, but also undertake task-oriented, hands-on
work.
The candidate must be comfortable and adept at building productive relationships throughout the correctional health care
field, developing and delivering clear communications with a
wide variety of stakeholders, presenting and speaking in public,
and thinking on his/her feet. Commitment to building a collaborative environment with staff and volunteers is essential.
If you are interested in this exciting opportunity, please contact us
for details about job responsibilities and objectives, candidate
qualifications and general information about NCCHC.
Edward Harrison, President
National Commission on Correctional Health Care
1145 W. Diversey Parkway, Chicago, IL 60614
773-880-1460 • [email protected]
www.ncchc.org
have their own tough challenges) but
to provide some perspective and
defeat myths.
Next, we started getting the message out by getting an audience with
legislators and state fiscal officials
whenever and wherever we could.
Sometimes our own field staff were
our best links since many of them
knew legislators in their communities. In these meetings we point out
all of the issues that necessitate our
services (history, court decisions)
and drive our costs (morbidity in the
inmate population, the need to bring
the care to the patient). Then we let
them know every initiative we had
done and plan to do. Most were surprised that we had already implemented most managed care industry
tactics and were so competitive with
free world providers.
Make no mistake, there is no
expectation that politicians will ever
expend political capital championing
health care for prison inmates. But
we can already see that some understanding of our issues is taking root
with this audience and we hope that
will change the discussion in less
public forums where decisions are
often made. This will surely serve us
better in the future than leaving
them to their perceptions.
Robert Bradford, MHA, is the managing director of Georgia Correctional
Health Care, Augusta, a division of
the Medical College of Georgia that
provides health care services to the
Georgia Department of Corrections.
Letters . . . Letters . . . Letters . . .
Put Them in Coach, They Are
Ready to Play
It is with wide-eyed astonishment
that I read of unfolding events in
California and Michigan. Last year, a
federal court judge appointed Robert
Sillen (a local public health director)
to oversee the costly and apparently
dismal health care system at the
California Department of Corrections.
In Michigan, Robert Johnson (a former HMO COO) has been hired to
fold the Department of Corrections
health care system into an HMO
model due primarily to cost.
These fellows are no doubt superb
in every measure and my beef is not
with them. Rather, why are systems
turning to others when a wealth of
expert advice is warmed up and ready
to play? A team such as Hron, Kern,
Murray, Parish and Rechtine, not to
mention Harrison, Stanley and
Chavez of NCCHC, to name a very
few, could have stepped to the plate
and hit one out of the park.
So why don’t our players get to
play? Pondering this question left me
with one clear reason. Our players
wear the wrong jersey. In an ironic
backfire, our ability to accomplish so
much rests with working as part of
the corrections team. Working from
within has garnered opportunity for
long-lasting change. We partner with
custody so as to simultaneously practice good medicine and support the
overall mission of corrections. This is
the essence of our worth. It is the
reason for our success. We can deliver
in an environment that is inherently
antihealth care, all the while changing
custody perceptions of health care
from behind the walls.
Fate has lumped us with the corrections side and therefore we are
labeled as part of corrections. We are
intentionally sidestepped in the belief
that to implement true change,
experts from outside corrections
must be retained. The irony is overwhelming as most systems have
incredibly high quality with reasonable costs. Model systems exist that
are manned by our players.
Perhaps the greatest twist of irony
is the fact that these new experts will
undoubtedly join our team. It is only
a matter of time before they adopt
our proven integrating strategy. They
will begin to play as we do because
this is what wins the game. I welcome
them, but also lament the fact that
our starters never had the chance.
Richard Garden, MD, CCHP
Clinical Director
Utah Department of Corrections
Hep C ‘Cure’ Not All It Seems
I just read the Spring 2007 issue
(Vol. 21, Issue 2). One news item
struck me as odd. “Study Demonstrates Potential Cure for Hepatitis
C” (p.17) makes it sound like 99% of
patients who are treated [with peginterferon alfa-2a] will be cured of
hepatitis C. Even the AIDSinfo At-aGlance seems to indicate this.
This is at odds with my own experience and that of which I’ve read over
the years. Indeed, when I checked
the study [see www.newswise.com/
articles/view/530150], I found that
it actually meant that 99% of those
who responded to the treatment
could be called cured. This is a big
difference because only about 50% or
less will respond to the treatment.
You might want to clarify this
before there is a big clamor to get
everyone identified and treated with
this expensive, partially effective, difficult-to-take treatment.
William Rankin, MD
Medical Director
East Moline (IL) Correctional Center
SUMMER 2007 • CorrectCare 3
CCHP News
Desire to Help Youth Drives CCHP’s Career
BY MATISSA SAMMONS
or Kelly Robinson-Bethea, MD,
CCHP, correctional health care
was a track she began very early
in her career, and one that would
prove to bring fulfillment in many
areas of her
life.
In fact,
this path
seemingly
chose her
when in
1997 she
began a fellowship at
Christiana
Care Health
Systems,
Wilmington, DE, where the correctional health care specialty was part
of her training in the division of adolescent and young adult medicine.
During the fellowship she served as a
medical administrator in Delaware’s
juvenile corrections system, where
the medical director, who was nearing retirement, primed her to step
up to that role.
F
Bethea took the position in 2000.
It wasn’t all smooth sailing: “It can
be a challenge to work within a system you have no control over,” she
says. Still, she found great satisfaction and reward working with this
population.
Conference Leads to Love
That same year, Bethea attended
NCCHC’s National Conference in St.
Louis, where she presented a session
on substance abuse in the juvenile
correctional system. While attending
a preconference seminar luncheon,
one of many networking events at
the conference, Bethea met Vern
Bethea, assistant chief operating officer at the New York City Department
of Corrections. Bethea says he was
very friendly, maybe overly friendly.
But that was fine, because she was
greatly enjoying herself lunching
with other attendees she had
befriended that morning.
On her way to dinner that night,
she ran into LaVern again. They
started talking and found out they
had far more in common than correctional health care. They enjoyed
spending time together and soon
forged a friendship.
Two years later, Bethea moved to
New York to become the medical
administrator for two small correctional facilities in Brooklyn. She and
Vern soon married and they now
have two children, ages 16 months
and three years.
Positive Impact
Shortly after the St. Louis conference, Bethea pursued certification as
a way to strengthen her involvement
with and support of the health care
of incarcerated youth. She believes
that juveniles are a misunderstood
population typically viewed as “bad
kids” rather than as individuals. She
notes that in a range of ages from 11
to 19, some are teenagers, some
children, but all are essentially still
kids. By and large they’ve had no
opportunity, nor role models, to
learn to become adults.
Bethea says it is a responsibility,
especially when working with juveniles, to appreciate the impact an
advocate can make on an impressionable population. With every youth
she sees, she asks what they want to
be when they get older and a light
bulb seems to turn on—a realization
that they in fact have a future, and
that someone cared to ask.
At present Bethea is an assistant
professor of pediatrics and an attend-
Board Welcomes New CCHPs
The CCHP board of trustees congratulates the latest professionals
to earn certification in correctional
health care. Through dedication
and study, these new CCHPs have
demonstrated mastery of national
standards and the knowledge
expected of leaders in this field.
The 103 individuals listed on
page 5 passed proctored examinations in May, June and July at test
sites across the country, including
Florida, Missouri, Nevada, North
Carolina and Wisconsin. They join
thousands of correctional health
care professionals who have earned
this distinguished credential.
Not a CCHP yet? To learn how
you can become certified, visit us
at online www.ncchc.org or call
773-880-1460.
ing physician for the division of adolescent medicine at Children’s and
Women’s Physicians of Westchester,
NY. She also serves at two group
homes in Pleasantville.
But she is feeling a tug to work
with youth in the justice system and
is planning to return to some form of
correctional health care. “I miss the
opportunity to have a positive impact
on someone’s life. It’s very rewarding
when you help a juvenile to realize
their unrecognized potential.”
Matissa Sammons is the certification
coordinator at NCCHC.
CCHP Activities at the National Conference
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4 SUMMER 2007 • CorrectCare
CCHP Lounge
Kick back and relax in this “VIP club” for CCHPs and their guests. Think of
it as an oasis away from the hustle and bustle of the conference activities.
Sponsored by the CCHP board of trustees, the lounge is open Monday
through Wednesday during regular conference hours.
Advanced CCHP Roundtable
CCHP-As are invited to attend this exclusive meeting of some of the most
experienced and knowledgeable leaders in the correctional health care
field. Mark your calendar for Tuesday, Oct. 16, 8:15 to 9:15 a.m.
CCHP Exam Dates & Locations
• Oct. 14: Nashville, TN – at the
National Conference on
Correctional Health Care
• Feb. 23: Regional sites to include
Rancho Cucamonga, CA, Ludlow,
MA, Guaynabo, PR, and others to
be determined
• May 18: San Antonio, TX – At the
Updates in Correctional Health
Care conference
• Aug. 23: Regional sites to be determined
• Oct. 19: Chicago, IL – At the
National Conference on
Correctional Health Care
We will try to accommodate candidates who are farther than a threehour drive from a test site. Please
make your request for a test site near
you at least 90 days in advance.
Visit the CCHP Web page at
www.ncchc.org for the most up-todate list of exam dates and locations.
You also can download the application booklet and study guide at the
site, and can complete an online
application form.
If you are interested in hosting an
exam at your facility or volunteering
to proctor an exam, please contact
certification coordinator Matissa
Sammons at [email protected] or
773-880-1460, ext. 277.
www.ncchc.org
Congratulations to the 103 Newest CCHPs!
Kathleen Y. Allen, RN, BA, CCHP
California Department of Corrections and
Rehabilitation
Diamond Springs, CA
Jennifer Babbitt, RN, CCHP
Ada County Sheriff's Office
Boise, ID
Todd Bannister, ADN, CCHP
Eddy County Detention Center
Carlsbad, NM
William J. Blanchard, CCHP
Southeast State Correctional Facility
Claremont, NH
Justin L. Blevins, BSN, CCHP
USMS/JPATS – U.S. Public Health Service
Parkville, MO
Sara Brady, RN, CCHP
Canyon County Detention Center
Middleton, ID
Antoinette S. Briscoe, BA, CCHP
Alvin S. Glenn Detention Center
Columbia, SC
Lori C. Burnett, RN, CCHP
Albemarle Charlottesville Regional Jail
Waynesboro, VA
Nancy K. Bushoven, BS, RN-C, CCHP
Volusia House
Daytona Beach, FL
Karen Byrnes, BSN, RN, CCHP
Michigan Department of Corrections
Trout Creek, MI
Ronald Cavanaugh, PsyD, CCHP
Alabama Department of Corrections
Montgomery, AL
Angela Chandler, BSN, CCHP
Eastern Reception, Diagnostic and
Correctional Center
Bonne Terre, MO
Christopher C. Charter, RN, CCHP
Purgatory Correctional Facility
Hurricane, UT
Charles Chastain, MD, CCHP
Eastern Reception, Diagnostic and
Correctional Center
Bonne Terre, MO
Tracy A Cook, RN, CCHP
Hastings Youth Academy
Green Cove Springs, FL
Joel Cosme Sr., MA, CCHP
Brevard Correctional Institution
Titusville, FL
Kim J.R. Coulson, RN, CCHP
Algoa Correctional Center
Jefferson City, MO
Debbie K. Crouell, CCHP
North Carolina Department of Corrections
LaGrange, NC
Lee Darnell, BS, MBA, CCHP
North Carolina Department of Corrections
Greenville, NC
Debra D. Dean, RN, CCHP
Ron Jackson State Juvenile Corr. Complex
Brownwood, TX
Sonia A. del Castillo, CCHP
Seminole County Sheriff’s Office
Sanford, FL
Carl H. Dell, MS, MPA, CCHP
Prison Health Services
Milton, FL
Mark DiAlesandro, MS, CCHP
Westmoreland County Prison
Vanderbilt, PA
John M. Dunham, BA, CCHP
Racine Correctional Institution/STF
Union Grove, WI
Paulette K. Dunster, BSN, CCHP
Sawyer County Sheriff’s Office
Springbrook, WI
www.ncchc.org
Steven F. Ritter, DO, CCHP
California Department of Corrections and
Rehabilitation
Chula Vista, CA
Laura Easley, RN, BSN, PHN, CCHP
Contra Costa County Juvenile Hall
Dixon, CA
Linda W. Lawrence, RN, ASN, CCHP
Prison Health Services
Tallassee, AL
Michael J. Ebert, RN, CCHP
First Medical Management
LaVergne, TN
Amanda L. Lindner, ASN, RN, CCHP
Wisconsin Dept. of Corrections RYOCF
Elkhorn, WI
Wendy K. Ellison, BSN, CCHP
Wisconsin Resource Center
Winnebago, WI
Melissa M. Luce, BSN, RN, CCHP
Wisconsin Resource Center
Oshkosh, WI
Ramona J. Elverson, RN, CCHP
South Dakota Health Department
Hot Springs, SD
Jocelyn D. Lumitap, BSN, CCHP
Orange County Sheriff's Department
Santa Ana, CA
Sheila M. Ruales, RN, CCHP
Naphcare, Inc.
North Las Vegas, NV
Milo M. Farnham, MD, CCHP
Correctional Medical Services
Independence, MO
Mary L. Lyall, LPN, CCHP
Highlands County Sheriff’s Office
Sebring, FL
Gwen D. Sadler, MSN, CCHP
NaphCare, Inc.
Birmingham, AL
Lana K. Fowler, MSN, CCHP
Correctional Medical Services
Kansas City, MO
Ruth Lynch, BSN, CRNP, JD, CCHP
NaphCare, Inc.
Birmingham, AL
Donald A. Scheurer, DO, CCHP
Martin County Jail
Port St. Lucie, FL
Rosary Gifford, RN, BA, CCHP
Armor Correctional Services
North Miami Beach, FL
Carol A. Martin, BSN, CCHP
Kenosha County Detention Center
Salem, WI
Hartmut Schmitz, MBA, CCHP
Wexford Health Sources Inc.
Pittsburgh, PA
Janet A. Graves, RDH, BS, CCHP
Minnesota Department of Corrections
St. Paul, MN
Deborah A. Massetti, FNP-C, PA-C, CCHP
CHM – Madera County Jail
Fresno, CA
Sharon D. Shulby, RN, CCHP
Long Beach Police Department
Manhattan Beach, CA
Trey Greeley, RN, BSN, CCHP
Wisconsin Dept. of Corrections RYOCF
Racine, WI
Edith McDaniel, RN, CCHP
South Central Correctional Center
Licking, MO
Kyra M. Griffin, RN, CCHP
Wisconsin Dept. of Corrections RYOCF
Racine, WI
Jeanna R. McNaughton, BSN, RN, CCHP
NaphCare, Inc.
Birmingham, AL
Susan J. Smith, BSN, CCHP
North Carolina Correctional Institution
for Women
Raleigh, NC
Christine Gurk, RN, BSN, CCHP
G4S Youth Services
Polk City, FL
Jenny Meehan, BSN, CCHP
Western Reception, Diagnostic and
Correctional Center
St. Joseph, MO
Michael C. Hakala, DO, CCHP
SECC
Bardwell, KY
Deborah S. Roach, CDA, CCHP
Rowan Correctional Center #4540
Salisbury, NC
Serina D. Rognlien-Hood, RN, CCHP
Spring Valley, CA
Lisa D. Spain, RN, BSN, CCHP
Potosi Correctional Center
Mineral Point, MO
Phyllis G. Stanley, ADN, RN, CCHP
Ozark Correctional Center
Fordland, MO
Barbara Minter, RN, CCHP
Prison Health Services
Ocala, FL
Horace O. Stroud, BS, CCHP
Harris County Sheriffs Office
Katy, TX
Peggy S. Minyard, MSHCA, BSN, CCHP
NaphCare, Inc.
Helena, AL
David M. Tatarsky, MA, JD, CCHP
South Carolina Department of Corrections
Columbia, SC
Brooke A. Moore-Reese, BSN, RN, CCHP
North Las Vegas Detention Center
Las Vegas, NV
Penny M. Tester, LPN, CCHP
Sullivan County Sheriff’s Office
Blountville, TN
Carolyn E. Holmes, RN, CCHP
Neuse Correctional Institution
Goldsboro, NC
Michelle Morgan, DO, MS, CCHP
Naphcare, Inc.
Birmingham, AL
James Scott Thayer, MD, CCHP
North Florida Reception Center – FDOC
Jacksonville, FL
Juanita A. Howell, CCHP
Neuse Correctional Institution
Seven Springs, NC
Ellen M. Muzzy, LVN, CCHP
Mendocino County Jail
Ukiah, CA
Audrey Renee Todaro, MSN, CCHP
South Central Correctional Center
Licking, MO
Marilyn Hubert, ASN, CCHP
Correctional Medical Services
Vandalia, MO
Trudeau T. Nichols, LPN, CCHP
North Carolina Department of Corrections
Fremont, NC
Leon Vickers, RN, CCHP
Jefferson City Correctional Center
Jefferson City, MO
Patricia Imbriaco, BSN, MPA, CCHP
Correctional Medical Services
Jefferson City, MO
Kenneth A. Norton, DDS, CCHP
Monterey, CA
Deborah M. Vinson, RN, CCHP
Southeast Correctional Center
Charleston, MO
Michael C. Harlow, MD, JD, CCHP
University of South Dakota
Aberdeen, SD
Teresa Rose Heavican, BS, CCHP
Nebraska Department of Correctional
Services
Raymond, NE
Shirley James, RNC, MSN, ARNP-C, CCHP
Dade County Jail
Miami, FL
Sharan D. Johnson, RN, BSN, CCHP
North Carolina Department of Corrections
High Shoals, NC
Christine A. Pace, RNC, CCHP
Anoka County Correctional Health
Isanti, MN
Candace L. Palmer, RN, CCHP
Algoa Correctional Center
Jefferson City, MO
Debbie M. Walrath, RN, MSN, CCHP
Wisconsin Resource Center
Winnebago, WI
Sandra L. Walsvick, LVN, CCHP
University Hospital System
San Antonio, TX
Gerald L. Jorgenson, MBA, BSN, CCHP
Correctional Medical Services
Russellville, MO
Shanta Pribble, RN, CCHP
Eastern Reception, Diagnostic and
Correctional Center
Arnold, MO
Catherine D. Keck, LPN, CCHP
Highlands County Sheriff’s Office
Lake Placid, FL
Kimberly S. Randolph, BSN, CCHP
Potosi Correctional Center
Mineral Point, MO
Janet C. White, RN, CCHP
Caliente Youth Center
Caliente, NV
Leila Ann Lamun, RNc, CCHP
Mendocino County Jail
Ukiah, CA
Elizabeth Rantz, MD, CCHP
Montana Department of Corrections
Missoula, MT
David C. Williams, MD, CCHP
Medical Care Associates, PA
Jackson, MS
Valerie D. Langley, RN, CCHP
Neuse Correctional Institution
Goldsboro, NC
Karen Rea, MSN, RN, PHN, FNP, CCHP
California Department of Corrections and
Rehabilitation
Fresno, CA
Shirley M. Winkler, RN, CCHP
HPL Ltd. – Oneida County Jail
Rhinelander, WI
Robert Larrow, RN, MS, BSN, CCHP
Schenectady County Correctional Facility
Malta, NY
Roberta E. Last, BSN, CCHP
Dodge Correctional Institution
Rosendale, WI
Jinece Rees, RN, CCHP
WMCC – Correctional Medical Services
Cameron, MO
Joseph Reinhardt, MD, CCHP
Miami Dade Corrections
Miami Beach, FL
David Weich, CCHP
Ada County Jail
Nampa, ID
Gladys Gail Wollberg, RN, CCHP
Missouri Eastern Correctional Center
Eureka, MO
Lori A. Young, RN, CCHP
Missouri Eastern Correctional Center
High Ridge, MO
SUMMER 2007 • CorrectCare 5
Academy News
Academy Events Take Center Stage at Conference
These are some of the activities and
events being planned by and for
Academy members at the National
Conference on Correctional Health
Care. For the most up-to-date schedule of events, visit our Web site:
www.correctionalhealth.org
Welcome Reception
Monday, Oct. 15, 4:30 to 5:30 p.m.
The Academy of Correctional Health
Professionals is proud to be a
cosponsor of the conference. Please
join us on Monday afternoon for a
welcome reception. This is an ideal
opportunity to network with your
colleagues. Enjoy light refreshments
while you learn more about the
Academy and the benefits of membership. Open to all attendees.
Exhibition
Sunday, Oct. 14 - Tuesday, Oct. 16
Stop by the Academy booth (#220)
to check out our Web site demo, cast
your vote for the board of directors,
meet other members and volunteers,
sign up to become a mentor or just
say “hi.”
Shared Interest Discussion Groups
The Academy’s education committee
invites you to participate in the
annual roundtable discussions. Based
on feedback from past participants,
we’re changing the format this year:
The discussion groups will take place
throughout the conference during
regularly scheduled concurrent sessions. This will give each group more
room to spread out and make it easier to hear.
The roundtable discussion groups
are small, informal gatherings for
the purpose of education, information sharing and idea exchange. They
also provide a unique opportunity to
meet other conference attendees.
You need not be an Academy member to participate.
Fifth Annual Academy Day
Ad
Wexford Health Sources
1/3 page
4/c
Tuesday, Oct. 16
Help us celebrate Academy Day by
participating in the special activities
taking place throughout the day,
including raffles in the exhibit hall,
special discounts on membership
and the annual meeting. Show your
pride in the Academy and your profession by wearing your Academy
apparel on Tuesday.
Annual Membership Meeting
Tuesday, Oct. 16, 5:15 to 6 p.m.
The annual meeting of Academy
members will take place at the convention center immediately after the
day’s educational program. The
agenda will feature reports from
committee chairs and staff, results of
the 2007 election, a call for volunteers and time for questions.
new PDF
Career Advancement
Made Easy
The Academy CareerCenter is the
premier online career resource for
correctional health professionals. We
understand your career needs and
have the right employers who can
appreciate your experience and talent.
Advanced Features to
Enhance Your Experience
Whether you are looking to advance
your career or just want to update
your résumé, the CareerCenter is your
first stop in managing your career.
• Job Agent: Set your criteria and
have select jobs come to you by RSS
or e-mail.
• Document Manager: Post up to five
documents—published articles,
research papers, partial portfolios and
more!
• Manage Your Search: Use Save
Favorite Jobs and Application History
to manage your job search.
Post Your Résumé Today
The first 50 members to post their
resume (through Nov. 15) will be
entered into a raffle to receive one
year’s free membership.
http://careers.correctionalhealth.org
Annual Board & Committee
Meetings
Members of the Academy’s committees will meet throughout the conference in preparation for their
annual report to the members and
board of directors. In addition, the
newly composed 2008 board of directors will meet to review business
from the past year and to establish
priorities for the coming year and
beyond.
National Conference Scholarship Winners
After careful deliberation of the many applications received, the Academy’s
education committee has awarded scholarships to the following members.
The scholarships cover the $325 registration fee and a $300 travel stipend
to attend the National Conference on Correctional Health Care in Nashville.
At Wexford Health, we take our responsibilities seriously.
That’s why we have been a trusted partner to more than
250 correctional facilities across the country. From
providing a wide-range of medical services to creating
customized programs for each of our clients, the
pride we take in meeting your needs is plain to see.
MEDICAL
MENTAL HEALTH
DENTAL
PHARMACY
STAFFING
EMR
UTILIZATION MANAGEMENT
CLAIMS PROCESSING
TELEMEDICINE
412-937-8590
WWW.WEXFORDHEALTH.COM
6 SUMMER 2007 • CorrectCare
• Diana Antonio, BSN, CCHP, a nurse at the Marvin County Jail, Napa, CA
• Darlene Huff, CCHP, a medical technician at the Abraxas Youth Center,
South Mountain, PA
• Amy Randt, LPN, CCHP, a nursing supervisor at the Abraxas Youth
Center, South Mountain, PA
Committee members unanimously agreed that these three candidates met
the scholarship criteria and cited their dedication and enthusiasm.
Says Huff, “I look forward to attending the conference, not only as a
break from family and work but also for the opportunity to grow professionally in our greatest pride, the medical care we provide to our kids
(clients).”
We look forward to hearing back from our scholarship winners on their
conference experience!
www.ncchc.org
Legal Affairs
Privacy of Inmate Medical Records Still Not Clear
BY WILLIAM C. COLLINS, JD
uestions as to whether inmates
have a constitutionally protected right to privacy and, if so,
the scope of such a right continue to
scrabble for a legal foothold. Two district court decisions, both dealing
with disclosure of an inmate’s HIV
status, provide examples.
In Richey v. Ferguson (W.D. Ark.
2007), the inmate said jail staff disclosed to other inmates that he was
HIV positive in a number of different
ways. A time sheet posted outside his
segregation cell door had the letters
“HIV” printed on it. His food came on
Styrofoam trays. He heard an officer
tell another inmate, in the presence
of a family friend, that he had AIDS.
The opinion does not discuss any
explanation the defendants may have
offered to justify these disclosures.
In Simpson v. Joseph (E.D. Wisc.
2007), the facts present a clear, dramatic intrusion into the doctorpatient relationship and without
question breach traditional medical
confidentiality. Correctional officers
at the Racine Correctional Institution
in Wisconsin accompanied inmates
from disciplinary segregation into
medical exam rooms. They did not
stand just outside the door but
remained within a few feet of the
inmate during the entire medical
encounter.
Officers who disclosed information
they heard during medical exams
were subject to discipline and,
according to defendants, were
trained to “disregard and not to listen to such conversations.” (While
some participants in training may
not listen to the trainer, training
someone not to listen seems an
ambitious goal, to say the least.)
Prison officials offered securitybased justifications for the practice.
They said that stationing an officer
outside the exam room was not an
acceptable alternative because the
officer could not intervene immediately to prevent an attack on a medical provider. The officer’s presence
could deter attacks. Inmates with
communicable diseases could be
deterred from biting medical staff in
an attempt to spread the disease.
Q
Editor’s Note
NCCHC’s Standards for Health
Services do protect rights to privacy
for patients in prisons, jails and
juvenile facilities. For instance, in
A-09 Privacy of Care, Compliance
Indicator 3 states that security personnel may be present at a clinical
encounter only if the patient poses
a probable risk to the safety of the
health care provider or others. Also
relevant is H-02 Confidentiality of
Health Records and Information.
www.ncchc.org
“There is also concern that
because of past experience with an
HSU [health services unit] staff member, an inmate at RCI may target
that staff member for harm, because
of a perception of inadequate care”
from that staff member, the decision
says, although it gives no more detail
about the “past experiences.”
Because the inmate in Simpson
was proceeding pro se, he offered
no expert testimony to challenge
the concerns expressed by the
defendants.
The Case Law Applied
In both cases, the courts accepted
the principle that there is a
“Fourteenth Amendment right to
privacy that protects medical information concerning an inmate’s HIVstatus from unjustified disclosures by
governmental actors.” Both cases
ground their right of privacy conclusion on two circuit court decisions,
Doe v. Delie (3rd Cir. 2001) and
Powell v. Schriver (2nd. Cir. 1999).
While both those decisions recognize the right, they agree that its
scope is limited by the Turner test.
Thus, legitimate penological interests in conflict with the right can
reduce its scope. Doe and Powell
both say that in evaluating tensions
between the right and legitimate
penological interests, courts must
give considerable deference to the
judgments of prison or jail officials.
In both Richey and Simpson, the
court found that the disclosures the
plaintiffs complained of did not cross
the constitutional line.
In Richey, the court did not use
the Turner test magic words but
essentially applied the test in the following language: “We do not believe
a detainee’s constitutional right to
privacy is violated when he is segregated, given meals on foam trays, his
activities are restricted, or those he
is in close contact with are advised of
his HIV positive status. Detention
center personnel have an obligation
to take necessary measures for their
own safety and the reasonable safety
of other detainees.” In making this
statement, the court did not engage
in anything close to a searching
examination of reasons behind the
defendants’ actions, especially how
telling another inmate about Mr.
Richey’s HIV status furthered a legitimate penological interest.
In Simpson, the court clearly
applied the Turner test, its discussion of the issue beginning with the
words “...if the challenged RCI policy
is reasonably related to a valid penological interest, there is no constitutional violation.”
Who Can Be Told What?
One of the oldest questions about
inmate medical privacy is whether
custody staff can be given information about an inmate’s medical condition. This question became controversial when HIV arrived in prisons.
Could custody staff be told “Inmate
X is HIV positive”? The response
from the medical profession and
from inmate advocates was an
emphatic “no.” Telling staff meant
that sooner or later, other inmates
would know and, at least in the
1980s, that meant the HIV-positive
inmate would be in danger.
The alternative was “universal precautions.” Assume everyone has
some sort of communicable disease
spread through blood or other bodily
fluids. While the professional community embraced the concept of universal precautions, courts have never
climbed on the medical privacy bandwagon regarding HIV status disclosures. There is certainly no body of
case law that condemns such disclosures or sets bright line rules about
what can and cannot be revealed to
custody staff about an inmate’s medical problems.
These two decisions continue that
trend. Both involve disclosure of very
sensitive information and neither
judge spent any time or worry in saying the disclosures did not violate
the inmates’ right to privacy, even to
the point of not condemning telling
an inmate about another inmate’s
HIV status.
These cases would help a defendant caught in a similar case to
argue for qualified immunity. With
these two federal district courts’
results, how can it be said that an
inmate has a clearly established right
that puts his HIV status (or other
sensitive medical information) off
limits to nonmedical personnel?
able to make an “immediate
response” if the inmate “turned violent” and that the officer’s physical
presence deterred aggressive behavior. The plaintiff said these concerns
were exaggerated but the court
brushed this aside, saying “plaintiff
is not a security expert and has not
produced evidence from any person
with qualifications in the area of
prison security to controvert the
defendants’ evidence.”
This one-sidedness leaves one wondering if the results might have been
different had the plaintiffs been represented by counsel who could have
provided expert testimony.
William C. Collins, JD, is the coeditor
of Correctional Law Reporter. This
article was originally published in the
June/July 2007 issue of CLR, ©2007
Civic Research Institute, Inc., and is
reprinted here in abridged form with
permission of the publisher. All rights
reserved. For subscription information, contact Civic Research Institute,
4478 U.S. Route 27, P.O. Box 585,
Kingston, NJ 08528; 609-683-4450;
www.civicresearchinstitute.com.
THE MENTALLY
DISORDERED
INMATE AND
THE LAW
Second Edition
By Fred Cohen, LL.B., LL.M.
The Pro Se Disadvantage
A common problem in a pro se case
involving a Turner test legal question
is that the plaintiff, who is not an
expert, has no expert to support his
contentions and must use data
obtained through discovery to rebut
the defendants’ security assertions.
What is the rational connection
between institutional safety and
security and telling an inmate that
another inmate is HIV positive? Or
posting a sign on the inmate’s cell
that says “HIV”? Was there a history
of inmates from segregation assaulting medical staff? What is the practice in other prisons? Was there any
indication that officers who sat in on
medical exams in fact kept whatever
they heard confidential?
As an example of the inherent
problems the pro se inmate faces,
the plaintiff in Simpson argued that
the institution’s security needs
would be met if the officer remained
directly outside the exam room.
Officials said the officer would not be
NEW EDITION!
Pre-Publication
Orders
Save $40!
“… should be in every correctional
institution’s mental health
staff library”
—Jeffrey L. Metzner, M.D., Clinical
Professor of Psychiatry, University
of Colorado Health Sciences Center
“Without the rigorous research and
brilliant legal analysis Fred Cohen
provides in this marvelous book,
legal advocates and experts would be
totally out of their element.”
—Terry A. Kupers, M.D., M.S.P.
Pre-publication price: $180 plus $17.50
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Price after November 1, 2007: $237.50.
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SUMMER 2007 • CorrectCare 7
Dental Care for the Medically Compromised Patient
BY MARK SZAREJKO, DDS
any inmates share two basic
problems: poor oral health
and one or more chronic
medical conditions. The extent of
decay and periodontal disease leaves
many teeth beyond repair, with their
surgical removal the only method of
definitive treatment.
Oral surgery patients must be able
to withstand the physical and emotional demands that the procedure
places on them. But a coexisting
medical condition can undermine
the dentist’s ability to perform even
M
a minor surgical procedure. And if
the patient is taking medications for
that condition, the normal intraoperative use of antibiotics, analgesics
and local anesthesia may need to be
modified.
Before initiating any invasive treatment the dentist must review the
medical history with the patient. It
may have been many months since
the initial physical assessment was
completed, so it must be noted if
any changes have occurred, if medication dosages have changed or if a
new medication has been prescribed.
This review should be noted on the
chart. If there is any doubt or conflict
as to the accuracy of the medical history, the medical director should be
contacted.
This article will highlight how the
most common medical conditions
can affect the delivery of dental
treatment.
Hypertension
Hypertension was the most common
medical problem among the dental
patients in our jail. The concern is
that a surgical procedure may trigger anxiety that can cause an already
elevated blood pressure to attain lev-
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6
els that could jeopardize cardiovascular health.
Clinical judgments vary as to the
blood pressure levels beyond which
surgery should not be performed. I
use a reading of 160/100, in any
combination, as the cutoff where I
would defer oral surgery until the
readings were lowered. In several
cases, patients have been referred to
the medical department when their
BP remained elevated.
Many local anesthetics contain
vasoconstrictors, such as epinephrine or levonordefrin, that benefit
the patient during the oral surgery.
These compounds decrease systemic
absorption of the local anesthetic
and prolong its effect, and help to
minimize bleeding. However, they
also can increase blood pressure, so
the least amount possible must be
used.
Also, since dental pain can raise
blood pressure, preoperative analgesics that do not interact with the
blood pressure medications can be
prescribed.
Cardiac Disease
Closely related to hypertension is
cardiac disease, and many patients
present with both. In such cases, the
precautions used for both conditions
must be followed.
When oral surgery was indicated
for patients with cardiac disease, my
protocol is to consult with the medical director to determine if the cardiac function is of sufficient quality
to withstand the rigors of oral
surgery.
Elective dental treatment should
be deferred for any patient who has
had a heart attack in the past six
months. It is during this interval that
the chance for a second heart attack
is the greatest. Similarly, a patient
with unstable angina in which chest
pain occurs at rest also is not a candidate for oral surgery because this
degree of instability could be a precursor to heart attack.
If pain or infection of dental origin
requires dental treatment during the
six-month period following a heart
attack, it should be done in the
office of a practitioner or a hospitalbased dental program that can monitor vital signs and can respond to a
cardiac emergency. The same is true
of patients with uncontrolled cardiac
arrhythmias.
Many cardiac patients are on anticoagulant medications such as warfarin, clopidogrel and aspirin. These
drugs can prevent a blood clot from
forming within the extraction site
and the resultant oozing can be difficult to control. The dentist must
consult with the prescribing physician
before surgery is performed on these
patients. Usually, the medications
can be discontinued before surgery
and resumed the day after. The
schedule must be followed exactly as
directed by the physician, with
appropriate orders made in the preContinued on page 9
8 SUMMER 2007 • CorrectCare
www.ncchc.org
DENTAL CARE
(continued from page 8)
scribing record. To confirm that the
patient has discontinued the anticoagulant therapy, the dentist should
check with the nursing staff member
who dispenses medications before
the patient returns for treatment. It
is equally important to make sure
that dispensing of these medications
is resumed.
Care must be taken when prescribing medications for dental problems
in patients with cardiac conditions
because these patients may be taking several cardiac medications and
drug interactions may result.
Liver Disease
take their normal dosage of insulin
and eat their usual allotment on the
day of surgery and for their postsurgical course. If eating is difficult due
to postoperative pain or the need to
avoid surgical sites, liquid supplements can be used to provide nutrition and to maintain the proper
blood glucose levels. These levels
also should be monitored before the
surgery is performed.
It is imperative that diabetes
patients understand the dangerous
consequences of eating minimally or
not at all (because of postoperative
pain) while still taking their normal
dose of insulin.
Blood glucose levels that are a concern because they are too high or
too low before surgery are a reason
to defer surgery and to immediately
refer these patients to the medical
department.
Safety First
Meeting the dental needs of the correctional population in a safe manner requires diligence to identify and
monitor any existing medical problems. This discussion has focused on
some common medical conditions
and their impact on dental treat-
ment. There are numerous other
medical problems that affect the
inmate population. Each condition
must be evaluated and, if necessary,
referred to the medical department
to determine any treatment modifications that may be needed. Our
goal should be to minimize the
chance of a dental procedure ending
in a medical emergency.
Mark Szarejko, DDS, has practiced in
a jail setting in Florida for six years.
He will speak on this subject at the
2007 National Conference on Correctional Health Care in Nashville, TN.
Many inmates are infected with
hepatitis B or hepatitis C viruses as a
result of years of injection drug abuse
and alcohol abuse. The latter also
leads to cirrhosis. However, problems
associated with the liver may manifest with mild or no symptoms.
The liver is an important organ
with a multitude of functions. Those
that relate to dentistry include drug
metabolism and the synthesis of
coagulation factors that help enable
blood to clot properly at an extraction site. A liver that is cirrhotic or
infected with the hepatitis viruses
may not be able to perform these
functions.
Several local anesthetics, antibiotics and analgesics used in dentistry
are metabolized primarily by the
liver. Compromised liver function
could reduce the ability to clear these
drugs from the system. Therefore, a
dosage that is usually safe and effective when the liver functions normally
can reach levels that constitute a
toxic buildup.
Tests that measure liver function
and enzyme levels can be used to
assess its ability to work properly. A
physician should be consulted about
the test results to determine if dental treatment, especially oral
surgery, and medication regimens
should be modified, deferred or
changed completely.
It is a rare occasion when a patient
who has had a liver transplant can
receive dental treatment in a correctional facility. The medical director
must be consulted before any
invasive procedure is performed.
Immunosuppressive medications
designed to minimize the chance of
host rejection of the transplant and
anti-inflammatory medications such
as prednisone will impair the
patient’s ability to fight infections
and will prolong surgical recovery.
Diabetes
The problem of delayed recovery
from surgery also applies to patients
with diabetes mellitus. This complex
disease poses difficulties for patients
of all ages. Dental considerations
include delayed surgical healing and
a higher potential for postoperative
infections. Prophylactic antibiotic
coverage and postsurgical antibiotic
therapy may be needed for these
patients.
Insulin-dependent patients should
www.ncchc.org
SUMMER 2007 • CorrectCare 9
20703854(1).indd 1
2/24/07 9:54:50 AM
Staff Health Fair Celebrates Quality Improvement
BY DEBBIE RAAB, LISA DEBILIO, PHD, AND CARL
AUSFAHL, MS, RN, CPHQ
n June 16, 2007, something
strange was happening at the
New Jersey Department of
Corrections headquarters. There
were balloons, juggling, colorful
posters, prizes and great food. The
crowd was a potpourri, with some
people in business attire, some in
casual office wear and others in corrections uniforms. All were engaged
in lively discussions, celebrating a
job well done.
The event was the second annual
Performance Improvement Fair. The
theme was CQI—Data Mining &
Minding Data. Overall, 29 performance improvement teams, representing the work of more than 180
staff, exhibited their work at this festive event. Fourteen correctional
facilities proudly displayed examples
of their quality improvements at the
PI Fair, which provided a forum to
share the efforts, the struggles and
the results with their colleagues.
O
The Quality Mission
While continuous quality improvement is a requirement for accreditation by the National Commission on
Correctional Health Care, it also is a
critical practice for any health care
program striving for excellence.
NJDOC, like many other correctional
departments, has the responsibility
the QI directors for NJDOC, CMS
to ensure a constitutionally sound
and UCHC. Since 2005, two
health care system in a complex setstatewide trainings have been held
ting that includes a diverse mixture
for CQI participants, presenting key
of players and multiple service
concepts of the model, use of various
providers. To this end, the NJDOC is
PI tools and an experiential approach
attempting to make PI everyone’s
to learning. Small, multidisciplinary
business through multidisciplinary PI
groups worked through the steps of
teams.
the QI model using different tools to
In 2005, the NJDOC’s director of
medical services restructured the
statewide QI program, emphasizing the partnering of the NJDOC,
Correctional Medical Services
and University Correctional
HealthCare, a component of the
University of Medicine and
Dentistry of New Jersey. This
restructuring took existing programs from the two service
providers and placed them under
the NJDOC umbrella, incorporating elements from both.
This new endeavor also resulted Ralph Woodward, MD, director of medical services
in an expanded QI/PI mission,
at NJDOC, reviews posters at the fair.
one that fosters a genuine curiosity in staff to seek opportunities to
develop their own PI initiatives.
improve services; dedication to dataThe QI directors also attend many
driven improvement efforts; and
facility-based CQI meetings to offer
effective dissemination of relevant,
guidance and support, and they periaccurate and timely information to
odically meet with individual PI team
management and staff. One major
leaders to help them through their
outcome of this new focus was the PI
specific team or project difficulties.
Fair.
Another valuable resource is a stepAn important element of this new
by-step PI Workbook and Reference
system is frequent staff training on
Guide, created in collaboration with
QI concepts and practices. A general
University Behavioral Health Care
plan/design, measure, assess and
(a subsidiary of the University of
improve model was agreed upon by
Medicine and Dentistry).
A Fair Is Born
With more than 1,200 clinical care
providers and some 10,000 staff in
the state’s 14 correctional institutions, a way to acknowledge PI teamwork and achievements and to share
information was needed. The PI Fair
was the answer.
This event was adapted from a similar program developed at UBHC.
The idea was to create a forum for
staff to exchange improvement ideas,
share their successes and learning
experiences, and network with colleagues from other sites. The NJDOC
modified and implemented the concept in 2006. Appropriately, the fair
theme in the transition year was PI,
A Team Approach.
The PI teams keep accurate documentation of their efforts, planning
sessions and selection of interventions and implementation, as well as
monitoring the results. Using guidelines developed by the statewide
committee, teams that submit projects will assemble a 36"-by-48"
poster to display their efforts. A onepage written summary of each entry
is also required to provide an
overview of the process and status of
the PI activity. This summary is available as a handout at the fair.
A panel of judges representing the
three organizations (NJDOC, CMS
and UCHC) reviews each poster and
Continued on page 11
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10 SUMMER 2007 • CorrectCare
www.ncchc.org
FAIR
(continued from page 10)
assigns scores for eight elements:
clear planning process, sound and
explicit data-gathering design, evidence of use of the QI model, appropriate use and analysis of data, evidence of a follow-up plan, visual
appeal of the poster, reflection of the
NJDOC mission statement (“Protecting the Public—Changing Lives”) and
a clearly written project summary.
The rating is done independently
by each judge and then tallied to
identify the best performers. The five
highest scores determine the winners who receive plaques and ribbons
at the event. Afterwards, all posters
and awards are displayed at each of
the sites and are used for ad hoc
training for staff.
On the day of the fair, visitors
receive a brochure outlining the
day’s activities and projects on display. Senior leadership of NJDOC,
CMS and UCHC as well as the PI
team members celebrate accomplishments by attending the affair. To
keep the event festive, door prizes
are raffled off, decorations abound
and refreshments are served.
The ceremony acknowledges all
staff who worked on PI projects, and
all team participants receive a certificate of appreciation.
And the Winners Are...
This year’s first-place team focused
on the use of universal precautions
in the prison laundry in response to
an increase of staph/MRSA infection
cases in 2005. Interventions included
use of protective garments for
inmates working the soiled-linen
line, procedures to protect inmates
when changing smocks and washing
hands, and ongoing education of
laundry workers.
The team reduced MRSA incidence
by 36% over a 12-month period. The
multidisciplinary team included the
director of nursing, the infection
control nurse, NJDOC administrator,
NJDOC health services manager and
the facility laundry supervisor.
Positive clinical outcome, multidisciplinary collaboration and use of data
were the high points of this group.
The second-place team explored
the effectiveness of group versus
individual therapy at a youth correctional facility. Using a patient selfreport outcome measure (BASIS-24),
the team found no advantage to one
type of treatment over the other. The
team concluded that increasing
group treatment options might be
beneficial because it is a more efficient way to provide treatment and
apparently leads to the same patient
outcomes. This team was most
notable for appropriate use of data.
Increasing “out-of-cell” clinician
therapy contacts in administrative
segregation was the focus of the
third-place PI team. They found that
only 50% of administrative segregation inmates had participated in outof-cell contacts during a three-month
period. The team sent brochures to
inmates explaining the importance
of out-of-cell contacts and letters to
www.ncchc.org
escort officers explaining the policy
requirement for out-of-cell contact
and thanking them for their assistance in achieving compliance with
the policy. The team also consulted
with custody officers about initiating
the use of flexible cuffs.
These interventions resulted in
100% compliance with the out-of-cell
contact policy. This PI project highlighted the cooperative efforts of
administration, custody and mental
health staff. Outstanding accomplishment of positive outcome and
inclusion of custody staff are noteworthy.
Other PI teams’ projects include:
• Increasing the number of behavioral health inmates successfully
transitioning from different levels of
care
• Identification of variables impeding the start-up of therapy groups
• Effectiveness of smoking-cessation programs
• The effect of exercise groups on
reducing obesity in inmates taking
atypical antipsychotic medications
Still other examples are collaborative efforts to manage diabetes
through inmate education, decreasing the use of low-dose Seroquel as
treatment for insomnia and reducing
the number of inmates returning to
the “security threat management”
unit.
On the Right Track
After the event, we solicit feedback
through a brief survey. Insights
gleaned from the results help us to
develop better PI fairs and educational
offerings for the future. Feedback on
this year’s fair was very encouraging,
with positive responses for all categories surveyed. The poster presentations were rated on average even
higher than the program format,
which will change next year to have
winning teams give short presentations on their projects.
The QI directors are most pleased
with the overall acceptance and com-
mitment to CQI, as fostered by the
PI Fair, and plan to continue this pivotal event each year. Teams are
already working on projects that will
be presented at next year’s fair.
The authors are the quality improvement directors at their respective
institutions: Debbie Raab at the New
Jersey Department of Corrections,
Trenton; Lisa DeBilio, PhD, at
University Correctional Health Care,
Trenton, NJ; and Carl Ausfahl, MS,
RN, CPHQ, at Correctional Medical
Services, Ewing, NJ. To reach them,
e-mail [email protected].
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SUMMER 2007 • CorrectCare 11
Hand Hygiene: Can We Learn a Lesson From the OR?
BY PETER GRAVES, RN, BSN, CNOR
M
ultidrug-resistant pathogens
such as methicillin-resistant
Staphylococcus aureus have
become alarmingly common in correctional facilities. Clostridium difficile looms as a potential threat, while
others could be lurking in the wings.
The risk of transmission and exposure may extend well beyond correctional workers and inmates. Bacteria
can be brought home on the hands
and clothing of the correctional
health care worker, by visitors and by
inmates upon release or transfer.
The Centers for Disease Control
and Prevention states that the single
most important method to reduce
the risk of cross-contamination and
infection is good hand hygiene.
Proper hygiene interrupts the chain
of infection and reduces the potential for transmission of infectious
agents from the hands of a health
care worker. One can never render
the skin sterile, but proper hygiene
can reduce bacterial counts.
On first glance it seems quite simple, but routine proper performance
of hand hygiene is no easy task. In
hospitals, where antimicrobial soap,
water and waterless hand antiseptics
are readily available, hand hygiene
compliance has been reported to be
surprisingly low. One study found
only 48% compliance in a university
teaching hospital.
Correctional facilities face even
greater impediments, including physical barriers, security and lack of
washing facilities. Yet, proper hand
hygiene in correctional settings is
vital to preventing infections. It
must be the cornerstone of every
facility’s infection control plan.
So the questions that beg asking in
corrections are:
Busting Myths of
Correctional Mental HealthÊ
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• Does hand hygiene occur with
adequate frequency?
• Do the chosen hand hygiene
agents have the qualities necessary
to disinfect correctional health care
providers’ hands?
Back to Basics
To better understand why hand
hygiene is so important, we must
understand some of the basics, starting with the skin.
Skin is our largest organ and
serves many roles, one of which is
protection. The outer layer is called
the stratum corneum. It consists of
several layers of cells, layered like
loose stonework, which provides an
ideal structure and location for bacteria, often called colonizing bacteria, to reside and reproduce.
Bacteria on the skin are classified
as either transient or resident.
Transient bacteria, such as S. aureus,
exist on the surface and are more
easily removed or killed with hand
hygiene. Resident bacteria reside in
the deeper layers and are difficult to
remove. Soap (plain or antimicrobial), water and a friction source
(e.g., opposing hand) or a waterless
antiseptic (alcohol or a combination
of alcohol plus an active agent) hand
rub are used to remove and/or kill
the transient bacteria and as many
resident bacteria as possible.
Germs can be passed between people and objects by direct and indirect
contact. Hands can become contaminated with bacteria, viruses and soils
during normal activities such as
unlocking doors or typing on a keyboard, as well as physical contact.
A recent study found that for every
1,000 hospital admissions, 46
patients were infected or colonized
with MRSA. This rate is about 10
times greater than previous findings.
Are correctional facilities cleaner
than hospitals? Anecdotal data indicates that the MRSA infection/colonization rate among inmates probably exceeds that in hospitals.
Clearly, it is important to break
the chain of infection. When an
opportunity for hand hygiene is
missed or it is done improperly, bacteria and soils can be left on the
skin. All it takes is a break in the
skin for those germs to penetrate
the body’s protective system. They
only need an opportunity to cause an
infection or to be transferred.
Simple Prevention
Routinely washing the hands when
gloves are removed or when hands
become soiled will increase hand
hygiene frequency compared with
the current norm. The Association of
Professionals in Infection Control
and Epidemiology states that gloves
should not be a substitute for hand
washing.
There are several cleansing agents
from which to choose. One obvious
choice is plain soap and water. This
is recommended when hands are visiContinued on page 13
12 SUMMER 2007 • CorrectCare
www.ncchc.org
HANDWASHING
(continued from page 12)
The Science of Hand Hygiene
Persistence: The ability of the
antimicrobial agent to continue to
inhibit the regrowth of bacteria
after the initial application period.
Cumulative effect: A progressive
decrease in the numbers of
microorganisms recovered after
repeated application of an antimicrobial agent.
Residual kill: The ability of the
active agent to continue killing bacteria after the application is complete. Typically measured in hours.
bly soiled and when persistence and
cumulative effect are not important.
When the stakes are higher, additional
active agents should be considered.
One of the most important ways we
can prevent health-care-associated
infections is to choose and use hand
hygiene products wisely. The Association of periOperative Registered
Nurses recommends that hand antiseptics used in surgery be broad
spectrum, fast acting, nonirritating
and have a residual effect. While
most hand hygiene agents do not
garner as much attention as surgical
antiseptics, it is important to learn
the lessons of their use.
In correctional health care, the
ideal agent is one that has persistence, cumulative effect and residual
kill against bacteria (see box above).
These qualities are critical to reducing and keeping bacterial counts in
check. The product also should
enhance the skin’s natural protection.
Persistence can inhibit regrowth of
bacteria even after the hands are dry
and while gloves are worn. Cumulative effect means that when an antimicrobial agent is used repeatedly
over time, the bacterial count is progressively reduced. By the end of the
workweek, the count will be lower
than at the start. This reduction may
help enhance the skin’s natural ability
to defend against transient bacteria.
Look for a product that has of all
these attributes, plus the ability to
kill microbes residually. Residual kill
is often the missing element by
which a product gives added protection long after use.
Workers in high-risk environments,
such as correctional facilities, also
should seek antimicrobial agents
with a broad spectrum of activity. A
broad-spectrum agent will kill a wide
array of microorganisms.
Compliance Is Essential
When should one perform hand
hygiene in correctional facilities? In
a word, frequently! The longer
answer is whenever there is contact
with a potentially contaminated individual or surface. But does this really
happen? Unfortunately, it does not.
To increase compliance, there must
be a greater focus on education and
performance of all staff in the health
care setting.
Understandably, access to hand
washing facilities can be difficult in
www.ncchc.org
correctional settings. Furthermore,
the use of waterless, alcohol-based
agents may be restricted facilitywide
due to safety, health and inmate welfare concerns. But hand wipes with a
combination of alcohol and CHG
(chlorhexidine gluconate) could be
individually dispensed and used by
health and corrections staff in situations where access and security
issues are barriers (e.g., towers, corridors, exercise areas).
Correctional facilities should evaluate hand hygiene antiseptic agents
for their persistence, acceptability to
staff, dispenser system, portability,
etc. While cost cannot be ignored, it
should not be the primary factor.
The goal is not to save money by buying less expensive products; it is for
all staff to increase compliance by
using them frequently due to good
end-user acceptance.
In the long term, programs that
reduce infection rates may pay for
themselves by reducing medical
expenses and employee down time.
Ponder the treatment costs for one
MRSA infection. Prevention of one
infection would likely more than offset the cost of hand hygiene.
Education about and selection of
Drugs That Are Contraindicated or Not Recommended for Use With ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/
tenofovir disoproxil fumarate 300 mg):
Antifungal: voriconazole; Antihistamine: astemizole; Antimigraine: ergot derivatives (dihydroergotamine, ergonovine, ergotamine,
methylergonovine); Antiretrovirals: EMTRIVA, VIREAD, TRUVADA, SUSTIVA, Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir;
Benzodiazepines: midazolam, triazolam; Calcium channel blocker: bepridil; GI motility agent: cisapride; Neuroleptic: pimozide;
St. John's wort (Hypericum perforatum). For clinical comment, please see Table 7 in Full Prescribing Information.
Established and Other Potentially Significant Drug Interactions*: Alteration in Dose or Regimen May Be
Recommended Based on Drug Interaction Studies or Predicted Interaction
Antiretroviral agents
Protease Inhibitors — Amprenavir :�amprenavir concentration. Efavirenz has the potential to decrease serum
concentrations of amprenavir. Fosamprenavir calcium:�amprenavir concentration. Fosamprenavir (unboosted): Appropriate
doses of fosamprenavir and ATRIPLA with respect to safety and efficacy have not been established. Fosamprenavir/ritonavir:
An additional 100 mg/day (300 mg total) of ritonavir is recommended when ATRIPLA is administered with fosamprenavir/
ritonavir once daily. No change in the ritonavir dose is required when ATRIPLA is administered with fosamprenavir plus
ritonavir twice daily. Atazanavir:�atazanavir concentration,�tenofovir concentration. Plasma concentrations of atazanavir were
decreased by both efavirenz and tenofovir DF. Sufficient data are not available to make a dosing recommendation for
atazanavir or atazanavir/ritonavir with ATRIPLA. Therefore, co-administration of ATRIPLA and atazanavir is not recommended due
to concerns regarding decreased atazanavir concentrations. Indinavir:�indinavir concentration. The optimal dose of indinavir,
when given in combination with efavirenz, is not known. Increasing the indinavir dose to 1000 mg every 8 hours does not
compensate for the increased indinavir metabolism due to efavirenz. Lopinavir/ritonavir:�lopinavir concentration,�tenofovir
concentration. A dose increase of lopinavir/ritonavir to 600/150 mg (3 tablets) twice daily may be considered when used in
combination with efavirenz in treatment experienced patients where decreased susceptibility to lopinavir is clinically
suspected (by treatment history or laboratory evidence). Patients should be monitored for tenofovir-associated adverse
events. ATRIPLA should be discontinued in patients who develop tenofovir-associated adverse events.
Ritonavir:�ritonavir concentration,�efavirenz concentration. When ritonavir 500 mg every 12 hours was coadministered
with efavirenz 600 mg once daily, the combination was associated with a higher frequency of adverse clinical experiences (eg,
dizziness, nausea, paresthesia) and laboratory abnormalities (elevated liver enzymes). Monitoring of liver enzymes is
recommended when ATRIPLA is used in combination with ritonavir. Saquinavir:�saquinavir concentration. Should not be used
as sole protease inhibitor in combination with ATRIPLA.
NRTI — Didanosine:�didanosine concentration. Higher didanosine concentrations could potentiate didanosine-associated
adverse events, including pancreatitis, and neuropathy. In adults weighing >60 kg, the didanosine dose should be
reduced to 250 mg if coadministered with ATRIPLA. Data are not available to recommend a dose adjustment of
didanosine for patients weighing <60 kg. When coadministered, ATRIPLA and VIDEX EC® may be taken under fasted
conditions or with a light meal (<400 kcal, 20% fat). Coadministration of didanosine buffered formulation with ATRIPLA should
be under fasted conditions. Coadministration of ATRIPLA and didanosine should be undertaken with caution and patients
receiving this combination should be monitored closely for didanosine-associated adverse events. For additional
information, please consult the Videx/Videx EC (didanosine) prescribing information.
Other Agents
Anticoagulant — Warfarin:�or�warfarin concentration. Plasma concentrations and effects potentially increased or
decreased by efavirenz.
Anticonvulsants — Carbamazepine:�carbamazepine concentration,�efavirenz concentration. There are insufficient data to
make a dose recommendation for ATRIPLA. Alternative anticonvulsant treatment should be used. Phenytoin,
Phenobarbital:�anticonvulsant concentration,�efavirenz concentration. Potential for reduction in anticonvulsant and/or
efavirenz plasma levels; periodic monitoring of anticonvulsant plasma levels should be conducted.
Antidepressant — Sertraline:�sertraline concentration. Increases in sertraline dose should be guided by clinical response.
Antifungals — Itraconazole:�itraconazole and hydroxy-itraconazole concentration. Since no dose recommendation for
itraconazole can be made, alternative antifungal treatment should be considered. Ketoconazole:�ketoconazole concentration.
Drug interaction studies with ATRIPLA and ketoconazole have not been conducted. Efavirenz has the potential to decrease
plasma concentrations of ketoconazole.
Anti-infective — Clarithromycin:�clarithromycin concentration,�14-OH metabolite concentration. Clinical significance
unknown. In uninfected volunteers, 46% developed rash while receiving efavirenz and clarithromycin. No dose adjustment of
ATRIPLA is recommended when given with clarithromycin. Alternatives to clarithromycin, such as azithromycin, should be
considered. Other macrolide antibiotics, such as erythromycin, have not been studied in combination with ATRIPLA.
Antimycobacterials — Rifabutin:�rifabutin concentration. Increase daily dose of rifabutin by 50%. Consider doubling the
rifabutin dose in regimens where rifabutin is given 2 or 3 times a week. Rifampin:�efavirenz concentration. Clinical significance
of reduced efavirenz concentrations is unknown. Dosing recommendations for concomitant use of ATRIPLA and rifampin have
not been established.
Calcium channel blockers — Diltiazem: �diltiazem, desacetyl diltiazem, and N-monodesmethyl diltiazem. Diltiazem dose
adjustments should be guided by clinical response (refer to the complete prescribing information). No dose adjustment of
ATRIPLA is necessary when administered with diltiazem. Others (eg, felodipine, nicardipine, nifedipine, verapamil): �calcium
channel blocker. No data are available on the potential interactions of efavirenz with other calcium channel blockers that are
substrates of the CYP3A4 enzyme. The potential exists for reduction in plasma concentrations of the calcium channel blocker. Dose
adjustments should be guided by clinical response (refer to the complete prescribing information for the calcium channel blocker).
HMG-CoA reductase inhibitors: Atorvastatin: �atorvastatin concentration, Pravastatin :�pravastatin concentration,
Simvastatin:�simvastatin concentration. Plasma concentrations of atorvastatin, pravastatin, and simvastatin decreased with
efavirenz. Consult the complete prescribing information for the HMG-CoA reductase inhibitor for guidance on individualizing
the dose.
Narcotic analgesic: Methadone:�methadone concentration. Coadministration of efavirenz in HIV-infected individuals with a
history of injection drug use resulted in decreased plasma levels of methadone and signs of opiate withdrawal. Methadone
dose was increased by a mean of 22% to alleviate withdrawal symptoms. Patients should be monitored for signs of
withdrawal and their methadone dose increased as required to alleviate withdrawal symptoms.
Oral contraceptive — Ethinyl estradiol:�ethinyl estradiol concentration. Clinical significance unknown. Because the
potential interaction of efavirenz with oral contraceptives has not been fully characterized, a reliable method of barrier
contraception should be used in addition to oral contraceptives.
*Please see full Prescribing Information (Tables 1–5, 7, 8) for additional information; this list is not all inclusive.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Efavirenz: Long-term carcinogenicity studies in mice and rats were carried out with efavirenz. Mice were dosed with 0, 25,
75, 150, or 300 mg/kg/day for 2 years. Incidences of hepatocellular adenomas and carcinomas and pulmonary
alveolar/bronchiolar adenomas were increased above background in females. No increases in tumor incidence above
background were seen in males. In studies in which rats were administered efavirenz at doses of 0, 25, 50, or 100 mg/kg/day
for 2 years, no increases in tumor incidence above background were observed. The systemic exposure (based on AUCs) in
mice was approximately 1.7-fold that in humans receiving the 600-mg/day dose. The exposure in rats was lower than that in
humans. The mechanism of the carcinogenic potential is unknown. However, in genetic toxicology assays, efavirenz showed
no evidence of mutagenic or clastogenic activity in a battery of in vitro and in vivo studies. These included bacterial mutation
assays in S. typhimurium and E. coli, mammalian mutation assays in Chinese hamster ovary cells, chromosome aberration
assays in human peripheral blood lymphocytes or Chinese hamster ovary cells, and an in vivo mouse bone marrow micronucleus
assay. Given the lack of genotoxic activity of efavirenz, the relevance to humans of neoplasms in efavirenz-treated mice is not
known. Efavirenz did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats. The
reproductive performance of offspring born to female rats given efavirenz was not affected. As a result of the rapid clearance
of efavirenz in rats, systemic drug exposures achieved in these studies were equivalent to or below those achieved in humans
given therapeutic doses of efavirenz. Emtricitabine: In long-term carcinogenicity studies of emtricitabine, no drug-related
increases in tumor incidence were found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the
therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/day (31 times the human systemic exposure at the therapeutic
dose). Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or mouse
micronucleus assays. Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at
approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose. Fertility was
normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of
approximately 60-fold higher than human exposures at the recommended 200 mg daily dose. Tenofovir disoproxil fumarate:
Long-term oral carcinogenicity studies of tenofovir DF in mice and rats were carried out at exposures up to approximately 16
times (mice) and 5 times (rats) those observed in humans at the therapeutic dose for HIV infection. At the high dose in female
mice, liver adenomas were increased at exposures 16 times that in humans. In rats, the study was negative for carcinogenic
findings at exposures up to 5 times that observed in humans at the therapeutic dose. Tenofovir DF was mutagenic in the
in vitro mouse lymphoma assay and negative in an in vitro bacterial mutagenicity test (Ames test). In an in vivo mouse
products ideally suited for high-risk
environments are the keys to reducing infections. Recognizing the
avoidable risk and taking action is
essential. We must go back to basics:
Everyone should be washing and
degerming their hands. It works in
the operating room; let’s give it a try
in corrections.
Peter Graves, RN, BSN, CNOR, is a
senior clinical nurse consultant with
Mölnlycke Health Care US, LLC,
Norcross, GA. Reach him by e-mail
at [email protected].
micronucleus assay, tenofovir DF was negative when administered to male mice. There were no effects on fertility, mating
performance, or early embryonic development when tenofovir DF was administered to male rats at a dose equivalent to 10 times
the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 15 days prior to
mating through day seven of gestation. There was, however, an alteration of the estrous cycle in female rats.
Pregnancy
Pregnancy Category D (see WARNINGS, Reproductive Risk Potential):
Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. Studies in rats have demonstrated that both efavirenz
and tenofovir are secreted in milk. It is not known whether efavirenz, emtricitabine, or tenofovir is excreted in human milk.
Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers
should be instructed not to breast-feed if they are receiving ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg).
Pediatric Use: ATRIPLA is not recommended for patients less than 18 years of age because it is a fixed-dose combination
tablet containing a component, tenofovir DF, for which safety and efficacy have not been established in this age group.
Geriatric Use: Clinical studies of efavirenz, emtricitabine, or tenofovir DF did not include sufficient numbers of subjects aged
65 and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly
patients should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy.
ADVERSE REACTIONS
For additional safety information about SUSTIVA (efavirenz), EMTRIVA (emtricitabine), or VIREAD (tenofovir DF) in combination
with other antiretroviral agents, consult the Prescribing Information for these products.
In addition to adverse events in study 934 (shown at the end of the discussion on the individual components of ATRIPLA), the
following adverse events were observed in clinical trials of efavirenz, emtricitabine, or tenofovir DF in combination with other
antiretroviral agents.
Efavirenz: The most significant adverse events observed in patients treated with efavirenz are nervous system symptoms
(see WARNINGS, Nervous System Symptoms), psychiatric symptoms (see WARNINGS, Psychiatric Symptoms), and rash
(see PRECAUTIONS, Skin Rash).
Selected clinical adverse experiences of moderate or severe intensity observed in *2% of efavirenz-treated patients in two controlled
clinical trials included pain, impaired concentration, anorexia, dyspepsia, abdominal pain, anxiety, nervousness, and pruritus.
Pancreatitis has been reported, although a causal relationship with efavirenz has not been established. Asymptomatic
increases in serum amylase levels were observed in a significantly higher number of patients treated with efavirenz 600 mg than
in control patients.
Emtricitabine and tenofovir disoproxil fumarate: Adverse events that occurred in at least 5% of patients receiving
emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials include anxiety, arthralgia, increased cough,
dyspepsia, fever, myalgia, pain, abdominal pain, back pain, paresthesia, peripheral neuropathy (including peripheral neuritis
and neuropathy), pneumonia, rhinitis and rash event (including rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash,
pustular rash and allergic reaction).
Skin discoloration has been reported with higher frequency among emtricitabine treated patients. Skin discoloration, manifested
by hyperpigmentation on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance
are unknown.
In addition to the laboratory abnormalities described for Study 934 below, Grade 3/4 elevations of bilirubin (>2.5 x ULN),
pancreatic amylase (>2.0 x ULN), serum glucose (<40 or >250 mg/dL), serum lipase (>2.0 x ULN) and urine glucose (*3+)
occurred in up to 3% of patients treated with emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials.
Selected Treatment-Emergent Adverse Events (Grades 2–4) Reported in ≥ 3% in Any Treatment Group in Study 934
(0–48 weeks) FTC + TDF + EFV (n=257), AZT/3TC + EFV (n=254), respectively: diarrhea (7%, 4%), nausea (8%, 6%),
vomiting (1%, 4%), fatigue (7%, 6%), sinusitis (4%, 2%), upper respiratory tract infections (3%, 3%), nasopharyngitis (3%, 1%),
somnolence (3%, 2%), headache (5%, 4%), dizziness (8%, 7%), depression (4%, 7%), insomnia (4%, 5%), abnormal dreams (4%, 3%),
rash (5%, 4%).
Significant Laboratory Abnormalities Reported in ≥1% in Any Treatment Group in Study 934 (0–48 weeks) FTC + TDF +
EFV (n=257) vs AZT/3TC + EFV (n=254), respectively: any * Grade 3 laboratory abnormality: 25%, 22%; fasting cholesterol
(>240 mg/dL): 15%, 17%; creatine kinase (M: >990 U/L, F: >845 U/L): 7%, 6%; serum amylase (>175 U/L): 7%, 3%; alkaline
phosphatase (>550 U/L): 1%, 0%; AST (M: >180 U/L, F: >170 U/L): 3%, 2%; ALT (M: >215 U/L, F: >170 U/L): 2%, 2%;
hemoglobin (<8.0 mg/dL): 0%, 3%; hyperglycemia (>250 mg/dL): 1%, 1%; hematuria (>75 RBC/HPF): 2%, 2%; neutrophil
(<750/mm3): 3%, 4%; fasting triglycerides (>750 mg/dL): 4%, 2%.
Lipids: In Study 934 at Week 48, the mean increase from baseline fasting triglyceride concentrations was 3 mg/dL for the
tenofovir DF, emtricitabine and efavirenz group and 31 mg/dL for the zidovudine/lamivudine and efavirenz group. For fasting
total, LDL, and HDL cholesterol concentrations, the mean increases from baseline were 21 mg/dL, 13 mg/dL, and 6 mg/dL,
respectively, for the tenofovir DF group and 35 mg/dL, 20 mg/dL, and 9 mg/dL, respectively, for the zidovudine/lamivudine group.
Hepatic Events: In Study 934, 10 patients treated with efavirenz, emtricitabine, and tenofovir DF and 16 patients treated with
efavirenz and fixed-dose zidovudine/lamivudine were hepatitis C antibody positive. Among these HCV coinfected patients, one
patient (1/10) in the efavirenz, emtricitabine and tenofovir DF arm had elevations in ALT and AST to greater than five times ULN
through 48 weeks. One patient (1/16) in the fixed-dose zidovudine/lamivudine arm had elevations in ALT to greater than five
times ULN through 48 weeks. Nine patients treated with efavirenz, emtricitabine and tenofovir DF and 4 patients treated with
efavirenz and fixed-dose zidovudine/lamivudine were hepatitis B surface antigen positive. None of these patients had treatmentemergent elevations in ALT and AST to greater than five times ULN through 48 weeks. No HBV and/or HCV coinfected patient
discontinued from the study due to hepatobiliary disorders (see PRECAUTIONS, Liver Enzymes).
Post Marketing Experience: In addition to adverse events reported from clinical trials, the following events have been identified
during post-approval use of efavirenz, emtricitabine, or tenofovir DF. Because they are reported voluntarily from a population of
unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion because of a
combination of their seriousness, frequency of reporting or potential causal connection.
Efavirenz: CARDIAC DISORDERS: Palpitations; EAR AND LABYRINTH DISORDERS: Tinnitus; ENDOCRINE DISORDERS:
Gynecomastia; EYE DISORDERS: Abnormal vision; GASTROINTESTINAL DISORDERS: Constipation, malabsorption; GENERAL
DISORDERS AND ADMINISTRATION SITE CONDITIONS: Asthenia; HEPATOBILIARY DISORDERS: Hepatic enzyme increase,
hepatic failure, hepatitis; IMMUNE SYSTEM DISORDERS: Allergic reactions; METABOLISM AND NUTRITION DISORDERS:
Redistribution/accumulation of body fat (see PRECAUTIONS, Fat Redistribution); hypercholesterolemia, hypertriglyceridemia;
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: Arthralgia, myalgia, myopathy; NERVOUS SYSTEM DISORDERS:
Abnormal coordination, ataxia, convulsions, hypoesthesia, paresthesia, neuropathy, tremor; PSYCHIATRIC DISORDERS:
Aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide; RESPIRATORY,
THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea; SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Flushing, erythema
multiforme, nail disorders, photoallergic dermatitis, skin discoloration, Stevens-Johnson syndrome.
Emtricitabine: No additional events have been identified for inclusion in this section.
Tenofovir disoproxil fumarate: IMMUNE SYSTEM DISORDERS: Allergic reaction; METABOLISM AND NUTRITION DISORDERS:
Hypophosphatemia, lactic acidosis; RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Dyspnea; GASTROINTESTINAL
DISORDERS: Abdominal pain, increased amylase, pancreatitis; HEPATOBILIARY DISORDERS: Increased liver enzymes, hepatitis;
RENAL AND URINARY DISORDERS: Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal tubulopathy,
proteinuria, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, polyuria, nephritis.
Ad
BMS / Gilead - Atripla PI
junior page
b/w
new PDF
Foster City, CA 94404
March 2007
SF-B0001AG-03-07
ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, and VIREAD are trademarks of
Gilead Sciences, Inc. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of
Bristol-Myers Squibb Company. Other brands listed are the trademarks of their respective owners.
© 2007 Bristol-Myers Squibb & Gilead Sciences, LLC
© 2007 Bristol-Myers Squibb Company
© 2007 Gilead Sciences, Inc.
SUMMER 2007 • CorrectCare 13
Telemedicine for Primary Care Proves Its Worth in Texas
BY CHARLES D. ADAMS, MD, MPH, STEPHEN
SMOCK, MBA, AND GARY J. EUBANK, RN, MSN
he University of Texas Medical
Branch at Galveston is the principal source of health care for
the Texas Department of Criminal
Justice. UTMB-Correctional
Managed Care provides medical, dental and psychiatric care to 120,000
inmates in a geographically scattered
prison system.
To better serve their needs, UTMBCMC has developed an extensive
telemedicine network. Since the service was implemented in the early
T
1990s, telemedicine has evolved into
a highly practical and dependable
method of conducting specialty clinics, with specialists at the UTMB
campus in Galveston evaluating and
managing the care of inmates in
remote prisons. The development of
better otoscopes, stethoscopes and
other devices has expanded the utility of telemedicine.
More recently, UTMB-CMC has
combined telemedicine technology
with a customized electronic medical
record system. This network, known
as Digital Medical Services, serves
TDCJ units throughout the state to
facilitate specialty services to inmates
with infectious and chronic diseases.
Because of our success in providing
specialty care via telemedicine, we
embarked on a pilot project in the
summer of 2006 to determine the
utility of the DMS network for providing primary care to TDCJ units
that had chronic or temporary
provider shortages.
Project Design
Several remote units with provider
shortages took part in the project.
UTMB-CMC employees at these units
were selected to operate the DMS
To place an order, please contact
your distributor/wholesaler,
visit www.MerckVaccines.com,
or call 1-800-MERCK-RX (1-800-637-2579).
equipment, present the patients to
the DMS primary care provider (PCP)
and perform other tasks to facilitate
the telemedicine consultation.
Although these employees could
be RNs or LVNs, they also included
clerical staff or nurse’s aides trained
in the DMS process and equipment
operation. In fact, because of the relatively short supply of nurses at these
units, we decided to use trained,
competent non-nursing personnel
whenever possible.
A central scheduling coordinator
was chosen and a scheduling process
developed. All requests for DMS services from the units were scheduled
through this coordinator’s office.
We identified a group of experienced
correctional midlevel providers from
units near Houston who could provide
primary care consultations via DMS.
We also created and filled a midlevel
position for this district to help provide this service. The Houston area
was selected because it would be easier to recruit providers from this
large metropolitan area.
In addition, a physician who had an
interest in this project had DMS
equipment installed in his home and
conducted visits from this setting.
The PCPs were rotated daily and
were available for consultations 8
hours per day, Monday through Friday,
6 a.m. to 2 p.m. They worked from
TDCJ offices near a prison in Sugar
Land, TX (adjacent to Houston).
On a typical day, DSM hosted three
clinics, each for a different prison
unit. Each session was usually scheduled for 2 hours and with an average
of 20 to 25 patients. This number
was chosen based on an estimated
10%-20% no-show rate. The providers
would either type their notes into
the EMR during the telemedicine
session or make handwritten notes
and enter the data into the EMR
after the clinic ended.
When a unit needed to schedule a
DMS-PCP clinic, it would contact the
central coordinator for a date and
time. The day before the clinic, a list
of patients from that unit was sent to
the DMS coordinator, who would
provide it to the PCP.
Shortly before the DMS visit, the
inmate’s vital signs were taken and
recorded. When required, laboratory
measurements such as fingerstick
gluccose testing, peak flow assessment and dip-stick urinalysis were
also performed.
Lessons Learned
VAQTA is a registered trademark of Merck & Co., Inc.
Copyright © 2006 Merck & Co., Inc.
All rights reserved.
20703856(1)-03/07-VAQ
14 SUMMER 2007 • CorrectCare
20703856(1).indd 1
• A nurse need not be present at
or involved in a DMS primary care
consultation provided that the presenter at the patients’ unit is thoroughly familiar with the EMR and
DMS equipment.
• Scheduling multiple clinics at
different sites requires strict adherence to the time allotted for each
clinic, and clinics must not start late
or run late. All participants should
be in place and ready to begin on
time; patients usually must arrive an
hour or so before their appointment.
www.ncchc.org
2/24/07 6:55:25 AM
TELEMEDICINE
(continued from page 14)
Unit “count” times must be taken
into consideration.
• Security plays an important role
in facilitating the smooth flow of
traffic during this busy and highly
productive time.
• Inmates requiring an interpreter
should be identified before the clinic
so that a single interpreter can be
present to translate.
• Patients with complicated medical conditions are not candidates for
the DMS-PCP clinic as they tend to
require lengthy visits, which disrupts
the clinic schedule.
• Having the PCPs conduct consultations from outside the prison circumvents security issues and allows
more time for seeing patients. Any
needed technical adjustments or
changes to the equipment can be
done more easily in this setting.
• Additional telemedicine clinics
can be scheduled and the time frame
for seeing patients extended in cases
of poor road conditions that might
prevent providers from driving to
some units. We learned this serendipitously during a severe ice storm.
• Some DMS patients required
referral to a unit provider because
the provider’s physical presence was
needed to further evaluate or treat
the patient. This situation occurred
with no more than 5% of patients.
Nurses in Short Supply
access at facilities involved in the
DMS-PCP project, we compared their
overall performance scores from the
5 months before the pilot with those
from the first 5 months of the pilot.
We found that the scores had
increased from 89.5% 94.6%, for a
net improvement of 5.1%.
Clearly, using DMS is an effective
way to evaluate and treat primary
care patients in remote prisons. This
model can accommodate many types
of health care requests on a predictable schedule and allows units
with limited on-site provider time to
focus on issues that require the phys-
ical presence of a provider (e.g., digital rectal exams, more detailed physical exams, pelvic exams, minor surgical procedures). The DMS also can
be used for many of the chronic care
conditions (e.g., hypertension, diabetes) that UTMB-CMC monitors
regularly, and for follow-up visits.
The authors are affiliated with the
Southern Division of UTMB Correctional Managed Care. Charles D.
Adams, MD, MPH, is medical director; Stephen Smock, MBA, is director
of operations; and Gary J. Eubank,
RN, MSN, is director of nursing.
1
#
Prescribed
NRTI
backbone1
#1 with Kaletra®*2 G #1 with Reyataz®*2 G #1 with Lexiva®*2 G #1 in African Americans2 G #1 in women2
Complement potent PI therapy with TRUVADA
TRUVADA is a DHHS-preferred NRTI backbone with Kaletra, Reyataz, and Lexiva†3
Cedric: successfully
maintaining PI therapy
(Reyataz + ritonavir)
with TRUVADA
Crunching the Numbers
Before the DMS-PCP pilot program,
we had only one viable option for
delivering care to the poorly staffed
units: use of a contract service at
$200 per hour. This service was estimated to be capable of seeing a maximum of 8 patients per hour. At a
cost of $1,600 per 8 hours and a
maximum of 64 patients, the estimated cost per patient visit would be
$25. The cost would increase with
fewer patients seen per hour.
In planning the DMS-PCP pilot, we
would use currently employed and
experienced midlevel providers at an
estimated hourly cost of $40. We also
hypothesized that our providers
could see more patients per hour
(i.e., 10) because of their familiarity
with the TDCJ system, the our formulary and our customized EMR. If
these numbers were achieved, the
unit providers, at a daily cost of $320
per 80 patients, could provide care
for $4 per patient visit.
During this pilot, 941 provider
hours were expended in conducting
5,321 telemedicine visits, yielding an
average of 6 patients per hour at an
average cost of $8.58 per patient
visit. DMS-PCP salaries averaged
$9,692 per month. In comparison,
the contracted services would have
cost $35,469 per month. Consequently, use of the DSM-PCP model
will save $309,000 in projected annualized costs for delivered services.
The contract between UTMB-CMC
and TDCJ stipulates that inmates
must be examined within certain
time limits after they request medical care. Thus, we collect monthly
“access to care” data. To gauge
www.ncchc.org
One of the major challenge of correctional health care in Texas, and
across the nation, is a chronic
shortage of nurses and other
health professionals, especially at
correctional facilities in isolated
rural communities. The shortage of
nurses has grown more severe in
recent years and the trend is
expected to continue.
The Texas Center for Nursing
Workforce Studies projects that
the state’s demand for nurses
“will rise by 86% by 2020, while
the supply will grow by only 53%
with strategies already in place.”
Texas will then be 71,000 FTEs
short of the nurses it will need.
Atazanavir 300 mg should be boosted
with ritonavir 100 mg and taken with
food when administered with TRUVADA.
Atazanavir without ritonavir should not
be coadministered with TRUVADA.
Patients on atazanavir or lopinavir/
ritonavir plus TRUVADA should be
monitored for TRUVADA-associated
adverse events. TRUVADA should be
discontinued in patients who develop
TRUVADA-associated adverse events.4
†As initial therapy for treatment-naïve patients with
Reyataz QD + ritonavir QD, Lexiva BID + ritonavir BID,
and Kaletra BID.
Indication and usage4
TRUVADA is indicated in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of
HIV-1 infection in adults.
Additional important information regarding the use of TRUVADA for the treatment of
HIV-1 infection:
• It is not recommended that TRUVADA be used as a component of a triple
nucleoside regimen
• TRUVADA should not be coadministered with ATRIPLA™ (efavirenz/emtricitabine/
tenofovir disoproxil fumarate), EMTRIVA® (emtricitabine), VIREAD® (tenofovir
disoproxil fumarate), or lamivudine-containing products‡
• In treatment-experienced patients, the use of TRUVADA should be guided by
laboratory testing and treatment history
Important safety information4
Lactic acidosis and severe hepatomegaly with steatosis, including fatal
cases, have been reported with the use of nucleoside analogs alone or
in combination with other antiretrovirals.
TRUVADA is not approved for the treatment of chronic hepatitis B virus
(HBV) infection, and the safety and efficacy of TRUVADA have not been
established in patients coinfected with HBV and HIV. Severe acute
exacerbations of hepatitis B have been reported in patients who have
discontinued EMTRIVA or VIREAD, the components of TRUVADA.
Hepatic function should be monitored closely with both clinical and
laboratory follow-up for at least several months in patients who are
coinfected with HIV and HBV and discontinue TRUVADA. If appropriate,
initiation of anti-hepatitis B therapy may be warranted.
• Emtricitabine and tenofovir are principally eliminated by the kidney. Renal
impairment, including cases of acute renal failure and Fanconi syndrome (renal
tubular injury with severe hypophosphatemia), has been reported in association
with the use of VIREAD
• It is recommended that creatinine clearance be calculated in all patients prior to
initiating therapy and as clinically appropriate during therapy with TRUVADA.
Routine monitoring of calculated creatinine clearance and serum phosphorus
should be performed in patients at risk for renal impairment
*Kaletra® (lopinavir/ritonavir), Reyataz® (atazanavir sulfate), Lexiva® (fosamprenavir calcium).
‡Combivir®, Epivir®, Epivir-HBV®, Epzicom™, and Trizivir®.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. TRUVADA,
EMTRIVA, and VIREAD are registered trademarks of Gilead Sciences, Inc.
ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
All other marks referenced herein are the property of their respective owners.
©2007 Gilead Sciences, Inc. All rights reserved. 07/07
®
emtricitabine tenofovir disoproxil fumarate
•
A proven part of HAART
Have you simplified
the NRTI backbone to
complement PI regimens?
• No dose adjustment is necessary for patients with mild renal impairment (creatinine
clearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum
phosphorus should be performed for these patients
• Dosing interval adjustment of TRUVADA and close monitoring of renal function are
recommended in all patients with creatinine clearance 30–49 mL/min. No safety or efficacy
data are available in patients with renal dysfunction who received TRUVADA using these
dosing guidelines, and so the potential benefit of TRUVADA therapy should be assessed
against the potential risk of renal toxicity. TRUVADA should not be administered to patients
with creatinine clearance <30 mL/min or patients requiring hemodialysis
• TRUVADA should be avoided with concurrent or recent use of a nephrotoxic agent
• Coadministration of TRUVADA with drugs that reduce renal function or compete for active
tubular secretion may increase serum concentrations of emtricitabine, tenofovir, and/or other
renally eliminated drugs
• Decreases in bone mineral density have been seen with the use of tenofovir DF. Cases of
osteomalacia (associated with proximal renal tubulopathy) have been reported in association
with the use of VIREAD
• Redistribution/accumulation of body fat has been observed in patients receiving
antiretroviral therapy
• Immune reconstitution syndrome has been reported in patients treated with combination
antiretroviral therapy
• Drug interactions have been observed between tenofovir DF and didanosine (ddI), atazanavir,
or lopinavir/ritonavir
• Please see full Prescribing Information for additional dose adjustments
• Coadministration of TRUVADA and ddI should be undertaken with caution, and the ddI
dose should be reduced to 250 mg for patients weighing >60 kg. Patients should be
monitored closely for ddI-associated adverse events
• Adverse events that occurred in clinical trials with the components of TRUVADA only or
TRUVADA + other antiretroviral agents occurring in at least 5% of patients included
abdominal pain, anxiety, arthralgia, back pain, diarrhea, dizziness, dyspepsia, fatigue, fever,
headache, increased cough, myalgia, nausea, pain, paresthesia (including peripheral neuritis
and neuropathy), pneumonia, rash events, and rhinitis
Please see brief summary of Prescribing Information on the following page.
References: 1. Based on data derived from PHAST retail monthly data, September 2005-April 2007. Wolters Kluwer
Health. 2. Synovate Healthcare Data, US HIV Monitor, 2007 Q1. 3. US Dept of Health and Human Services, DHHS Panel on
Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults
and adolescents. Version October 10, 2006. Available at: http://www.aidsinfo.nih.gov/contentfiles/adultandadolescentgl.pdf.
Accessed June 25, 2007. 4. TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) Prescribing Information. Gilead Sciences,
Inc. May 2007.
SUMMER 2007 • CorrectCare 15
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528
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727
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Before prescribing, see full Prescribing Information, including
boxed WARNINGS. The following is a brief summary for TRUVADA®
(emtricitabine/tenofovir disoproxil fumarate).
WARNINGS
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE ANALOGS ALONE OR IN COMBINATION WITH OTHER
ANTIRETROVIRALS (SEE WARNINGS).
TRUVADA IS NOT APPROVED FOR THE TREATMENT OF CHRONIC
HEPATITIS B VIRUS (HBV) INFECTION AND THE SAFETY AND
EFFICACY OF TRUVADA HAVE NOT BEEN ESTABLISHED IN PATIENTS
COINFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS
OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO HAVE
DISCONTINUED EMTRIVA OR VIREAD, THE COMPONENTS OF
TRUVADA. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY
WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT
LEAST SEVERAL MONTHS IN PATIENTS WHO ARE COINFECTED
WITH HIV AND HBV AND DISCONTINUE TRUVADA. IF APPROPRIATE,
INITIATION OF ANTI-HEPATITIS B THERAPY MAY BE WARRANTED
(SEE WARNINGS).
Rx Only
INDICATIONS AND USAGE
TRUVADA is indicated in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment
of HIV-1 infection in adults.
Additional important information regarding the use of TRUVADA for the treatment of
HIV-1 infection:
• It is not recommended that TRUVADA be used as a component of a triple
nucleoside regimen.
• TRUVADA should not be coadministered with ATRIPLATM (efavirenz/emtricitabine/
tenofovir disoproxil fumarate), EMTRIVA, VIREAD, or lamivudine-containing
products (see WARNINGS).
• In treatment experienced patients, the use of TRUVADA should be guided by
laboratory testing and treatment history.
CONTRAINDICATIONS
TRUVADA is contraindicated in patients with previously demonstrated hypersensitivity
to any of the components of the product.
WARNINGS
Lactic Acidosis/Severe Hepatomegaly with Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have
been reported with the use of nucleoside analogs alone or in combination with other
antiretrovirals. A majority of these cases have been in women. Obesity and
prolonged nucleoside exposure may be risk factors. Particular caution should be
exercised when administering nucleoside analogs to any patient with known risk
factors for liver disease; however, cases have also been reported in patients with
no known risk factors. Treatment with TRUVADA should be suspended in any
patient who develops clinical or laboratory findings suggestive of lactic acidosis or
pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in
the absence of marked transaminase elevations).
Patients Coinfected with HIV and Hepatitis B Virus
It is recommended that all patients with HIV be tested for the presence of chronic
hepatitis B virus (HBV) before initiating antiretroviral therapy. TRUVADA is not
approved for the treatment of chronic HBV infection and the safety and efficacy of
TRUVADA have not been established in patients coinfected with HBV and HIV.
Severe acute exacerbations of hepatitis B have been reported in patients who are
coinfected with HBV and HIV and have discontinued EMTRIVA or VIREAD. In
some of these patients treated with EMTRIVA, the exacerbations of hepatitis B were
associated with liver decompensation and liver failure. Hepatic function should be
monitored closely with both clinical and laboratory follow up for at least several
months in patients who are coinfected with HIV and HBV and discontinue
TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Renal Impairment
Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment,
including cases of acute renal failure and Fanconi syndrome (renal tubular injury
with severe hypophosphatemia), has been reported in association with the use of
VIREAD (see ADVERSE REACTIONS, Post Marketing Experience).
It is recommended that creatinine clearance be calculated in all patients prior to
initiating therapy and as clinically appropriate during therapy with TRUVADA.
Routine monitoring of calculated creatinine clearance and serum phosphorus
should be performed in patients at risk for renal impairment.
Dosing interval adjustment of TRUVADA and close monitoring of renal function are
recommended in all patients with creatinine clearance 30 – 49 mL/min (see
DOSAGE AND ADMINISTRATION). No safety or efficacy data are available in
patients with renal dysfunction who received TRUVADA using these dosing
guidelines, and so the potential benefit of TRUVADA therapy should be assessed
against the potential risk of renal toxicity. TRUVADA should not be administered to
patients with creatinine clearance <30 mL/min or patients requiring hemodialysis.
TRUVADA should be avoided with concurrent or recent use of a nephrotoxic agent.
Other
TRUVADA is a fixed-dose combination of emtricitabine and tenofovir disoproxil
fumarate. TRUVADA should not be coadministered with ATRIPLA, EMTRIVA, or
VIREAD. Due to similarities between emtricitabine and lamivudine, TRUVADA
should not be coadministered with other drugs containing lamivudine, including
Combivir ® (lamivudine/zidovudine [3TC/AZT]), Epivir ® or Epivir-HBV ®
(lamivudine), EpzicomTM (abacavir sulfate/lamivudine), or Trizivir® (abacavir sulfate/
lamivudine/zidovudine).
PRECAUTIONS
Drug Interactions
Tenofovir disoproxil fumarate: When tenofovir disoproxil fumarate was
administered with didanosine (Videx®, Videx EC®) the Cmax and AUC of didanosine
administered as either the buffered or enteric-coated formulation increased
significantly. The mechanism of this interaction is unknown. Higher didanosine
concentrations could potentiate didanosine-associated adverse events, including
pancreatitis, and neuropathy. Suppression of CD4 cell counts has been observed in
patients receiving tenofovir DF with didanosine at a dose of 400 mg daily. In adults
weighing >60 kg, the didanosine dose should be reduced to 250 mg when it is
coadministered with TRUVADA. Data are not available to recommend a dose
adjustment of didanosine for patients weighing <60 kg. When coadministered,
TRUVADA and Videx EC may be taken under fasted conditions or with a light meal
(<400 kcal, 20% fat). Coadministration of didanosine buffered tablet formulation with
TRUVADA should be under fasted conditions. Coadministration of TRUVADA
and didanosine should be undertaken with caution and patients receiving
this combination should be monitored closely for didanosine-associated
adverse events. Didanosine should be discontinued in patients who
develop didanosine-associated adverse events.
Atazanavir and lopinavir/ritonavir have been shown to increase tenofovir concentrations.
The mechanism of this interaction is unknown. Patients receiving atazanavir
and lopinavir/ritonavir and TRUVADA should be monitored for
TRUVADA-associated adverse events. TRUVADA should be discontinued
in patients who develop TRUVADA-associated adverse events.
Tenofovir decreases the AUC and Cmin of atazanavir. When coadministered with
TRUVADA, it is recommended that atazanavir 300 mg is given with ritonavir
100 mg. Atazanavir without ritonavir should not be coadministered
with TRUVADA.
Arkray USA
814
Armor Correctional Health Services 609
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504
ATC Health Care
729
Ballymore Medical Management
411
Biomedical Systems
909
Boehringer Ingelheim
203-205
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602
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Emtricitabine and tenofovir disoproxil fumarate: Since emtricitabine and
tenofovir are primarily eliminated by the kidneys, coadministration of TRUVADA
with drugs that reduce renal function or compete for active tubular secretion may
increase serum concentrations of emtricitabine, tenofovir, and/or other renally
eliminated drugs. Some examples include, but are not limited to acyclovir, adefovir
dipivoxil, cidofovir, ganciclovir, valacyclovir, and valganciclovir.
Bone Effects
Tenofovir disoproxil fumarate: In a 144-week study of treatment naïve patients,
decreases in bone mineral density (BMD) were seen at the lumbar spine and hip in
both arms of the study. At Week 144, there was a significantly greater mean
percentage decrease from baseline in BMD at the lumbar spine in patients receiving
VIREAD + lamivudine (3TC) + efavirenz (EFV) compared with patients receiving
stavudine + lamivudine + efavirenz. Changes in BMD at the hip were similar
between the two treatment groups. In both groups, the majority of the reduction in
BMD occurred in the first 24 – 48 weeks of the study and this reduction was
sustained through 144 weeks. Twenty-eight percent of VIREAD-treated patients vs.
21% of the comparator patients lost at least 5% of BMD at the spine or 7% of BMD
at the hip. Clinically relevant fractures (excluding fingers and toes) were reported in
4 patients in the VIREAD group and 6 patients in the comparator group. Tenofovir
disoproxil fumarate was associated with significant increases in biochemical
markers of bone metabolism (serum bone-specific alkaline phosphatase, serum
osteocalcin, serum C-telopeptide, and urinary N-telopeptide), suggesting increased
bone turnover. Serum parathyroid hormone levels and 1,25 vitamin D levels were
also higher in patients receiving VIREAD. The effects of VIREAD-associated
changes in BMD and biochemical markers on long-term bone health and future
fracture risk are unknown. For additional information, please consult the VIREAD
prescribing information.
Cases of osteomalacia (associated with proximal renal tubulopathy) have been
reported in association with the use of VIREAD (see Adverse Reactions, Post
Marketing Experience).
Bone monitoring should be considered for HIV infected patients who have a
history of pathologic bone fracture or are at risk for osteopenia. Although the effect
of supplementation with calcium and vitamin D was not studied, such
supplementation may be beneficial for all patients. If bone abnormalities are
suspected then appropriate consultation should be obtained.
Fat Redistribution
Redistribution/accumulation of body fat including central obesity, dorsocervical fat
enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement,
and “cushingoid appearance” have been observed in patients receiving
antiretroviral therapy. The mechanism and long-term consequences of these events
are currently unknown. A causal relationship has not been established.
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients treated with
combination antiretroviral therapy, including EMTRIVA and VIREAD. During the
initial phase of combination antiretroviral treatment, patients whose immune system
responds may develop an inflammatory response to indolent or residual
opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus,
Pneumocystis jirovecii pneumonia (PCP), or tuberculosis), which may necessitate
further evaluation and treatment.
Information for Patients
TRUVADA is not a cure for HIV infection and patients may continue to experience
illnesses associated with HIV infection, including opportunistic infections. Patients
should remain under the care of a physician when using TRUVADA.
Ad
Gilead - Truvada
2 of 2
junior page
emtricitabine tenofovib/w
r disoproxil fumarate
®
•
Patients should be advised that:
• the use of TRUVADA has not been shown to reduce the risk of transmission of
HIV to others through sexual contact or blood contamination,
• the long term effects of TRUVADA are unknown,
• TRUVADA Tablets are for oral ingestion only,
• it is important to take TRUVADA with combination therapy on a regular dosing
schedule to avoid missing doses,
• redistribution or accumulation of body fat may occur in patients receiving
antiretroviral therapy and that the cause and long-term health effects of these
conditions are not known,
• TRUVADA should not be coadministered with ATRIPLA, EMTRIVA, or VIREAD;
or with drugs containing lamivudine, including Combivir, Epivir or Epivir-HBV,
Epzicom, or Trizivir.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Emtricitabine: In long-term oral carcinogenicity studies of emtricitabine, no
drug-related increases in tumor incidence were found in mice at doses up to
750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of
200 mg/day) or in rats at doses up to 600 mg/kg/day (31 times the human systemic
exposure at the therapeutic dose).
Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test),
mouse lymphoma or mouse micronucleus assays.
Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male
and female mice at approximately 60-fold higher exposures (AUC) than in humans
given the recommended 200 mg daily dose. Fertility was normal in the offspring of
mice exposed daily from before birth (in utero) through sexual maturity at daily
exposures (AUC) of approximately 60-fold higher than human exposures at the
recommended 200 mg daily dose.
Tenofovir disoproxil fumarate: Long-term oral carcinogenicity studies of
tenofovir disoproxil fumarate in mice and rats were carried out at exposures up to
approximately 16 times (mice) and 5 times (rats) those observed in humans at the
therapeutic dose for HIV infection. At the high dose in female mice, liver adenomas
were increased at exposures 16 times that in humans. In rats, the study was negative
for carcinogenic findings at exposures up to 5 times that observed in humans at the
therapeutic dose.
Tenofovir disoproxil fumarate was mutagenic in the in vitro mouse lymphoma assay
and negative in an in vitro bacterial mutagenicity test (Ames test). In an in vivo
mouse micronucleus assay, tenofovir disoproxil fumarate was negative when
administered to male mice.
There were no effects on fertility, mating performance or early embryonic
development when tenofovir disoproxil fumarate was administered to male rats at a
dose equivalent to 10 times the human dose based on body surface area
comparisons for 28 days prior to mating and to female rats for 15 days prior to
mating through day seven of gestation. There was, however, an alteration of the
estrous cycle in female rats.
Pregnancy
Pregnancy Category B:
Emtricitabine: The incidence of fetal variations and malformations was not
increased in embryofetal toxicity studies performed with emtricitabine in mice at
exposures (AUC) approximately 60-fold higher and in rabbits at approximately
120-fold higher than human exposures at the recommended daily dose.
Tenofovir disoproxil fumarate: Reproduction studies have been performed in
rats and rabbits at doses up to 14 and 19 times the human dose based on body
new PDF
surface area comparisons and revealed no evidence of impaired fertility or harm to
the fetus due to tenofovir. There are, however, no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always predictive of
human response, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) should be
used during pregnancy only if clearly needed.
Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant
women exposed to TRUVADA, an Antiretroviral Pregnancy Registry has been
established. Healthcare providers are encouraged to register patients by calling
1-800-258-4263.
Nursing Mothers: The Centers for Disease Control and Prevention
recommend that HIV-infected mothers not breast-feed their infants
to avoid risking postnatal transmission of HIV. Studies in rats have
demonstrated that tenofovir is secreted in milk. It is not known whether tenofovir is
excreted in human milk. It is not known whether emtricitabine is excreted in human
milk. Because of both the potential for HIV transmission and the potential for
serious adverse reactions in nursing infants, mothers should be instructed not
to breast-feed if they are receiving TRUVADA.
Pediatric Use
Truvada is not recommended for patients less than 18 years of age because it is a
fixed-dose combination tablet containing a component, VIREAD, for which safety
and efficacy have not been established in this age group.
Geriatric Use
Clinical studies of EMTRIVA or VIREAD did not include sufficient numbers of
subjects aged 65 and over to determine whether they respond differently from
younger subjects. In general, dose selection for the elderly patients should be
cautious, keeping in mind the greater frequency of decreased hepatic, renal, or
cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
TRUVADA: Four hundred and forty-seven HIV-1 infected patients have received
combination therapy with EMTRIVA and VIREAD with either a non-nucleoside
reverse transcriptase inhibitor or protease inhibitor for 48 weeks in clinical studies.
Study 934 - Treatment Emergent Adverse Events: Adverse events observed
in this study were generally consistent with those seen in other studies in treatmentexperienced or treatment-naïve patients receiving VIREAD and/or EMTRIVA.
Selected treatment-emergent adverse events (grades 2 – 4) reported in ≥3% of
patients receiving EMTRIVA+VIREAD+EFV or AZT/3TC+EFV, respectively, in Study
934 during the first 48 weeks included diarrhea (7%, 4%), nausea (8%, 6%),
vomiting (1%, 4%), fatigue (7%, 6%), sinusitis (4%, 2%), upper respiratory tract
infections (3%, 3%), nasopharyngitis (3%, 1%), somnolence (3%, 2%), headache
(5%, 4%), dizziness (8%, 7%), depression (4%, 7%), insomnia (4%, 5%),
abnormal dreams (4%, 3%), and rash (5%, 4%).
Laboratory Abnormalities: Laboratory abnormalities observed in this study
were generally consistent with those seen in other studies of VIREAD and/or
EMTRIVA. In Study 934, Grade 3 or 4 laboratory abnormalities were reported by
25% of patients receiving EMTRIVA+VIREAD+EFV and 22% of patients receiving
AZT/3TC+EFV during the first 48 weeks. The following significant laboratory
abnormalities were reported in Study 934 during the first 48 weeks in ≥1% of
patients in the EMTRIVA+VIREAD+EFV or AZT/3TC+EFV treatment group,
respectively: fasting cholesterol (>240 mg/dL; 15%, 17%), creatine kinase
(M>990 U/L or F>845 U/L; 7%, 6%), serum amylase (>175 U/L; 7%, 3%), alkaline
phosphatase (>550 U/L; 1%, 0%), AST (M>180 U/L or F>170 U/L; 3%, 2%), ALT
(M>215 U/L or F>170 U/L; 2%, 2%), hemoglobin (<8.0 mg/dL; 0%, 3%),
hyperglycemia (>250 mg/dL; 1%, 1%), hematuria (>75 RBC/HPF; 2%, 2%),
neutrophils (<750/mm3; 3%, 4%), fasting triglycerides (>750 mg/dL; 4%, 2%).
In addition to the events described above for Study 934, other adverse events that
occurred in at least 5% of patients receiving EMTRIVA or VIREAD with other
antiretroviral agents in clinical trials include anxiety, arthralgia, increased cough,
dyspepsia, fever, myalgia, pain, abdominal pain, back pain, paresthesia, peripheral
neuropathy (including peripheral neuritis and neuropathy), pneumonia, rhinitis, and
rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous
rash, pustular rash and allergic reaction). Skin discoloration has been reported with
higher frequency among EMTRIVA treated patients. Skin discoloration, manifested by
hyperpigmentation on the palms and/or soles was generally mild and asymptomatic.
The mechanism and clinical significance are unknown. In addition to the laboratory
abnormalities described above for Study 934, Grade 3/4 elevations of bilirubin
(>2.5 x ULN), pancreatic amylase (>2.0 x ULN), serum glucose (<40 or >250 mg/dL),
serum lipase (>2.0 x ULN), and urine glucose (*3+) occurred in up to 3% of patients
treated with EMTRIVA or VIREAD with other antiretroviral agents in clinical trials. For
more information, please consult the EMTRIVA and VIREAD package inserts.
Post Marketing Experience
EMTRIVA: No additional events have been identified for inclusion in this section.
VIREAD: The following events have been identified during post-approval use of
VIREAD. Because they are reported voluntarily from a population of unknown size,
estimates of frequency cannot be made. These events have been chosen for
inclusion because of a combination of their seriousness, frequency of reporting or
potential causal connection to VIREAD: allergic reaction, hypophosphatemia,
lactic acidosis, dyspnea, abdominal pain, increased amylase, pancreatitis,
increased liver enzymes, hepatitis, rash, myopathy, osteomalacia (both
associated with proximal renal tubulopathy), renal insufficiency, renal failure,
acute renal failure, Fanconi syndrome, proximal tubulopathy, proteinuria,
increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus,
polyuria, interstitial nephritis (including acute cases), and asthenia.
DOSAGE AND ADMINISTRATION
The dose of TRUVADA is one tablet (containing 200 mg of emtricitabine and 300 mg
of tenofovir disoproxil fumarate) once daily taken orally with or without food.
Dose Adjustment for Renal Impairment: Significantly increased drug
exposures occurred when EMTRIVA or VIREAD were administered to patients with
moderate to severe renal impairment (see EMTRIVA or VIREAD Package
Insert). Therefore, the dosing interval of TRUVADA should be adjusted in patients
with baseline creatinine clearance 30–49 mL/min using the recommendations in
Table 1. These dosing interval recommendations are based on modeling of
single-dose pharmacokinetic data in non-HIV infected subjects. The safety and
effectiveness of these dosing interval adjustment recommendations have not been
clinically evaluated in patients with moderate renal impairment, therefore, clinical
response to treatment and renal function should be closely monitored in these
patients (see WARNINGS). No dose adjustment is necessary for patients with
mild renal impairment (creatinine clearance 50–80 mL/min). Routine monitoring of
calculated creatinine clearance and serum phosphorus should be performed for
these patients (see WARNINGS).
Table 1.
Dosage Adjustment for Patients with Altered Creatinine Clearance
Creatinine Clearance (mL/min)*
Recommended
Dosing Interval
≥ 50
30 – 49
<30 (Including Patients
Requiring Hemodialysis)
Every
24 hours
Every
48 hours
TRUVADA should
not be administered.
*Calculated using ideal (lean) body weight.
Gilead Sciences, Inc. Foster City, CA 94404 May 2007
TRUVADA, EMTRIVA, and VIREAD are registered trademarks of Gilead Sciences,
Inc. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
All other trademarks referenced herein are the property of their respective owners.
©2007, Gilead Sciences, Inc.
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16 SUMMER 2007 • CorrectCare
www.ncchc.org
Treating ADHD Vital to Reduce Recidivism in Youth
BY ROBERT F. EME, PHD
ttention-deficit/hyperactivity
disorder is the most commonly
diagnosed behavioral condition
among youth in the United States,
with an estimated prevalence rate of
about 7% in children.
However, ADHD is seen far more
often among incarcerated juveniles,
affecting at least 25% and maybe as
many as 50% of these youth. In the
general population, ADHD is more
common among males than females,
but in correctional settings, the
opposite may be true.
Despite these statistics, the impact
of ADHD in juvenile justice systems
and institutions is just starting to be
understood. Given that ADHD
increases the risk of recidivism, it is
critically important to identify and
treat this condition in youth.
A
regulation, low tolerance of frustration, explosive temper, irritability,
suggestibility
• Failure to appreciate the gravity
of a situation, poor time management, poor planning for the future
Recipe for Trouble
Importantly, impairment in executive function increases the risk for
developing oppositional-defiant disorder, which is seen among 55% of
youth with ADHD.
In turn, ODD often leads to development of conduct disorder, which is
the mental disorder equivalent of
delinquency. Studies indicate that
ADHD is present in 50% of youth
with CD.
These problematic behaviors
increase the risk of life difficulties
such as substance abuse and failures
in academics, the work world and
personal relationships. What’s more,
the toxic brew of ADHD/CD often
leads to criminal behavior and recidivism, especially among youth who
use illicit drugs.
Clearly, identification and treatment of ADHD is an essential component of mental health services in any
system that aims to prevent youth
delinquency and reduce recidivism.
An essential first step in any best
practices model would be to require
education on ADHD for lawyers,
judges, probation and parole officers,
and others who work in the juvenile
justice system. This would enable
them to more competently serve the
youth they deal with.
Robert F. Eme, PhD, is a professor of
psychology at Argosy University,
Schaumburg (IL) Campus. He will
copresent a session on this subject at
the 2007 National Conference on
Correctional Health Care in Nashville.
What Is ADHD?
ADHD is a neurobiological disorder
that impairs the brain’s executive/
management functions, thereby
impairing self-regulation and selfcontrol. About 80% of youth with
this disorder are born with it, while
20% acquire it later, for example
through brain trauma.
Executive function refers to various
brain mechanisms that prioritize,
integrate and regulate other cognitive and behavioral functions in
much the same way as an orchestra
conductor (executive) regulates
orchestra members (other cognitive
and behavioral functions).
Deficits in executive function may
lead to behaviors such as...
• Impulsivity, nonthinking, thrillseeking, impatience, difficulty in
delaying gratification, insatiability
• Failure to start, procrastination
• Disorganization, horrific money
management skills, inability to save
• Failure to sustain effort, follow
through and complete tasks
• Overreaction, poor emotional
ADHD: It’s the Real Deal
In the past, there has been some
controversy over whether ADHD is a
“real” mental disorder. That dispute can be laid to rest: All major
medical associations and health
agencies recognize that it is a legitimate disorder. These organizations
include the following:
• American Academy of Pediatrics
• American Psychiatric Association
• American Psychological Association
• American Medical Association
• National Institute of Mental Health
• U.S. Surgeon General
Useful Resource
The Centers for Disease Control
and Prevention funds the National
Resource Center on AD/HD, a
clearinghouse for science-based
information about all aspects of the
disorder, with resources for professionals and the general public. Visit
the site at www.help4adhd.org, or
call 800-233-4050.
www.ncchc.org
When beginning a first-line
HIV-combination therapy,
look for a pathway paved
in evidence.
Strong. Proven. Enduring.*
IMPORTANT INFORMATION ABOUT SUSTIVA® (efavirenz)
INDICATION:
SUSTIVA (efavirenz) in combination with other antiretroviral agents is indicated for the
treatment of HIV-1 infection.
*This indication is based on two clinical trials of at least one year duration that
demonstrated prolonged suppression of HIV RNA.
IMPORTANT SAFETY INFORMATION:
• Coadministration with astemizole, bepridil, cisapride, midazolam, pimozide,
triazolam, ergot derivatives, or standard doses of voriconazole is contraindicated.
If SUSTIVA is coadministered with voriconazole, the voriconazole maintenance
dose should be increased to 400 mg every 12 hours and the SUSTIVA dose should
be decreased to 300 mg once daily using the capsule formulation. SUSTIVA
tablets should not be broken.
• Concomitant use of SUSTIVA and St. John’s wort (Hypericum perforatum) or
St. John’s wort-containing products is not recommended.
• Coadministration of SUSTIVA with ATRIPLA™ (efavirenz 600 mg/
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is not recommended,
since efavirenz is one of its active ingredients.
• Serious psychiatric adverse experiences, including severe depression (2.4%),
suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive
behavior (0.4%), paranoid reactions (0.4%), and manic reactions (0.2%), have been
reported in patients treated with SUSTIVA. In addition to SUSTIVA, factors
identified in a clinical study that were associated with an increase in psychiatric
symptoms included history of injection drug use, psychiatric history, and use of
psychiatric medication. There have been occasional reports of suicide, delusions,
and psychosis-like behavior, but it could not be determined if SUSTIVA was the
cause. Patients with serious psychiatric adverse experiences should be evaluated
immediately to determine whether the risks of continued therapy outweigh the
benefits.
• Fifty-three percent of patients reported central nervous system symptoms,
including dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%),
somnolence (7.0%), abnormal dreams (6.2%), and hallucinations (1.2%), when
taking SUSTIVA compared to 25% of patients receiving control regimens.
These symptoms usually begin during Days 1-2 of therapy and generally resolve
after the first 2-4 weeks of therapy; they were severe in 2.0% of patients and
2.1% of patients discontinued therapy. After 4 weeks of therapy, the prevalence
of nervous system symptoms of at least moderate severity ranged from 5% to 9%
in patients treated with regimens containing SUSTIVA. Nervous system symptoms
are not predictive of less frequent serious psychiatric symptoms.
• SUSTIVA (efavirenz) may cause fetal harm when administered during the first
trimester to a pregnant woman. Women should not become pregnant or
breast-feed while taking SUSTIVA. Barrier contraception must always be used in
combination with other methods of contraception (eg, oral or other hormonal
contraceptives). If the patient becomes pregnant while taking SUSTIVA , she
should be apprised of the potential harm to the fetus.
• Mild-to-moderate rash is a common side effect of SUSTIVA. In controlled clinical
trials, 26% of patients treated with SUSTIVA experienced new-onset skin rash
compared with 17% of patients treated in control groups. SUSTIVA should be
discontinued in patients developing severe rash associated with blistering,
desquamation, mucosal involvement, or fever. Rash is more common and often
more severe in pediatric patients.
• Liver enzymes should be monitored in patients with known or suspected hepatitis
B or C, in patients treated with other medications associated with liver toxicity,
and when SUSTIVA is administered with ritonavir.
• Use SUSTIVA with caution in patients with a history of seizures. Convulsions have
been observed in patients receiving efavirenz, generally in the presence of known
medical history of seizures.
• Redistribution and/or accumulation of body fat have been seen in patients
receiving antiretroviral therapy. A causal relationship has not been established.
• Immune reconstitution syndrome has been reported in patients treated with
combination antiretroviral therapy, including SUSTIVA.
• Saquinavir should not be used as the only protease inhibitor in combination with
SUSTIVA. Please see the SUSTIVA Full Prescribing Information for complete list of
drug interactions.
• The most common adverse events (≥5%) observed in clinical studies with SUSTIVA
include fatigue, pain, dizziness, headache, insomnia, impaired concentration,
nausea, vomiting, diarrhea, depression, rash, and pruritus.
• The dose of SUSTIVA is one tablet once daily taken orally on an empty stomach,
preferably at bedtime, in combination therapy. The increased concentrations
following administration of SUSTIVA with food may lead to an increase in
frequency of adverse events. Dosing at bedtime may improve the tolerability of
nervous system symptoms.
Please see brief summary of Full Prescribing Information for SUSTIVA
on adjacent pages.
SUSTIVA and the SUNBURST LOGO are registered trademarks of Bristol-Myers Squibb
Pharma Company.
ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
www.sustiva.com
©2007 Bristol-Myers Squibb Company, Princeton, NJ 08543, U.S.A.
692US07AB03304 04/07
SUMMER 2007 • CorrectCare 17
In the News
Youth Suicide on the Rise
After a decade of falling rates, suicides among youth rose 8% from
2003 to 2004, according to a CDC
study reported in the Sept. 7 Morbidity and Mortality Weekly Report. In
contrast, suicide rates among youth
in the 10-24 age group fell 28% from
1990 to 2003. The study found significant increases particularly among
girls aged 10-19, as well as changes
in their suicide methods.
The report offers no reasons for
the reversal. However, in a Sept. 6
HealthDay News article, one expert
points to FDA warnings of a few years
ago that use of SSRI antidepressants
can increase teens’ risk of suicide. In
the years before those warnings, use
of the drugs led to declining suicide
rates. When prescribing decreased,
suicides increased.
While saying that this pattern is a
concern, the director of the FDA’s
Division of Psychiatry Products,
Center for Drug Evaluation and
Research, also noted the agency’s
obligation to report on drug risks.
The CDC report calls for closer
examination of these trends and for
prevention activities that focus on
these groups. The study is available
at http://www.cdc.gov/mmwr.
Youth Drug Use Declines
Now some good news: The rate of
adolescents ages 12 to 17 acknowledging drug use in the past month
dropped from 11.6% in 2002 to 9.8%
in 2006, the U.S. Substance Abuse
and Mental Health Services Administration recently announced.
The findings are from the 2006
National Survey on Drug Use and
Health, which also reported that cigarette use decreased over the same
period for people ages 18 to 25.
However, nonmedical use of prescription drugs, mainly pain relievers,
increased among young adults, from
5.4% in 2002 to 6.4% in 2006. The
level of underage drinking (ages 12
to 20) was unchanged at 28.3%.
Substance abuse problems and
mental illness often co-occur. For
example, 34.6% of 12- to 17-year-olds
who had a major depressive episode
in the past year had used illicit
drugs, compared to 18.2% who had
not experienced a major depressive
episode.
Survey findings are posted on the
Web at http://oas.samhsa.gov/
nsduhlatest.htm.
First Antipsychotic for Kids
The FDA has approved the use of
Risperdal (risperidone) in youth to
treat schizophrenia (ages 13-17) and
for short-term treatment of bipolar
disorder I (ages 10-17). Previously,
no drug had been approved for adolescent schizophrenia and only lithium was approved for bipolar disorder
for youth ages 12 and older.
Risperdal is a powerful antipsychotic drug that had been commonly
used off-label to treat these condi-
18 SUMMER 2007 • CorrectCare
tions in youth. The new approval is
based on studies that identified
effective dosages for these patients.
More information can be found at
www.fda.gov/oc/opt/default.htm.
First Drug in New Class of Anti-HIV Meds
The FDA has approved Selzentry
(maraviroc), the first drug to be
approved in the CCR5 coreceptor
antagonist class of anti-HIV medications. Maraviroc is approved for use
in combination with other antiretrovirals for the treatment of adults who
have exclusively CCR5-tropic HIV
virus, evidence of viral replication
and resistance to multiple antiretroviral medications.
Rather than fighting HIV inside
white blood cells, like most antiretrovirals used to treat HIV infection, maraviroc prevents the virus
from entering uninfected cells by
blocking the predominant route of
entry, the CCR5 co-receptor, a protein on the surface of immune cells
affected by HIV. Among patients who
have previously received HIV medica-
SUSTIVA®
(efavirenz) capsules and tablets
Brief summary of Prescribing Information, 01-07. For complete prescribing information, please consult official
package circular.
CONTRAINDICATIONS
SUSTIVA (efavirenz) is contraindicated in patients with clinically significant hypersensitivity to any of its
components.
SUSTIVA should not be administered concurrently with astemizole, bepridil, cisapride, midazolam, pimozide,
triazolam, or ergot derivatives because competition for CYP3A4 by efavirenz could result in inhibition of
metabolism of these drugs and create the potential for serious and/or life-threatening adverse events (eg,
cardiac arrhythmias, prolonged sedation, or respiratory depression). SUSTIVA should not be administered
concurrently with standard doses of voriconazole because SUSTIVA significantly decreases voriconazole plasma
concentrations. Adjusted doses of voriconazole and efavirenz may be administered concomitantly (see
CLINICAL PHARMACOLOGY, Tables 1 and 2 in Full Prescribing Information; PRECAUTIONS: Drug
Interactions, Table 1; and DOSAGE AND ADMINISTRATION: Dosage Adjustment in Full Prescribing
Information).
WARNINGS
ALERT: Find out about medicines that should NOT be taken with SUSTIVA. This statement is also included
on the product’s bottle labels. (See CONTRAINDICATIONS and PRECAUTIONS: Drug Interactions.)
SUSTIVA must not be used as a single agent to treat HIV-1 infection or added on as a sole agent to a failing
regimen. As with all other non-nucleoside reverse transcriptase inhibitors, resistant virus emerges rapidly when
efavirenz is administered as monotherapy. The choice of new antiretroviral agents to be used in combination
with efavirenz should take into consideration the potential for viral cross-resistance.
Coadministration of SUSTIVA with ATRIPLATM (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) is not
recommended, since efavirenz is one of its active ingredients.
Psychiatric Symptoms: Serious psychiatric adverse experiences have been reported in patients treated with
SUSTIVA. In controlled trials of 1008 patients treated with regimens containing SUSTIVA for a mean of 2.1 years
and 635 patients treated with control regimens for a mean of 1.5 years, the frequency of specific serious
psychiatric events among patients who received SUSTIVA or control regimens, respectively, were: severe
depression (2.4%, 0.9%), suicidal ideation (0.7%, 0.3%), nonfatal suicide attempts (0.5%, 0), aggressive
behavior (0.4%, 0.5%), paranoid reactions (0.4%, 0.3%), and manic reactions (0.2%, 0.3%). When psychiatric
symptoms similar to those noted above were combined and evaluated as a group in a multifactorial analysis of
data from Study 006, treatment with efavirenz was associated with an increase in the occurrence of these
selected psychiatric symptoms. Other factors associated with an increase in the occurrence of these psychiatric
symptoms were history of injection drug use, psychiatric history, and receipt of psychiatric medication at study
entry; similar associations were observed in both the SUSTIVA and control treatment groups. In Study 006,
onset of new serious psychiatric symptoms occurred throughout the study for both SUSTIVA-treated and
control-treated patients. One percent of SUSTIVA-treated patients discontinued or interrupted treatment
because of one or more of these selected psychiatric symptoms. There have also been occasional
postmarketing reports of death by suicide, delusions, and psychosis-like behavior, although a causal
relationship to the use of SUSTIVA cannot be determined from these reports. Patients with serious psychiatric
adverse experiences should seek immediate medical evaluation to assess the possibility that the symptoms
may be related to the use of SUSTIVA, and if so, to determine whether the risks of continued therapy outweigh
the benefits (see ADVERSE REACTIONS).
Nervous System Symptoms: Fifty-three percent of patients receiving SUSTIVA in controlled trials reported
central nervous system symptoms compared to 25% of patients receiving control regimens. These symptoms
included, but were not limited to, dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%),
somnolence (7.0%), abnormal dreams (6.2%), and hallucinations (1.2%). These symptoms were severe in 2.0%
of patients, and 2.1% of patients discontinued therapy as a result. These symptoms usually begin during the
first or second day of therapy and generally resolve after the first 2-4 weeks of therapy. After 4 weeks of
therapy, the prevalence of nervous system symptoms of at least moderate severity ranged from 5% to 9% in
patients treated with regimens containing SUSTIVA and from 3% to 5% in patients treated with a control
regimen. Patients should be informed that these common symptoms were likely to improve with continued
therapy and were not predictive of subsequent onset of the less frequent psychiatric symptoms (see
WARNINGS: Psychiatric Symptoms). Dosing at bedtime may improve the tolerability of these nervous system
symptoms (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION in Full Prescribing Information).
Analysis of long-term data from Study 006 (median follow-up 180 weeks, 102 weeks, and 76 weeks for
patients treated with SUSTIVA + zidovudine + lamivudine, SUSTIVA + indinavir, and indinavir + zidovudine +
lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous
system symptoms among SUSTIVA-treated patients were generally similar to those in the indinavir-containing
control arm.
Patients receiving SUSTIVA should be alerted to the potential for additive central nervous system effects when
SUSTIVA is used concomitantly with alcohol or psychoactive drugs.
Patients who experience central nervous system symptoms such as dizziness, impaired concentration, and/or
drowsiness should avoid potentially hazardous tasks such as driving or operating machinery.
Drug Interactions: Concomitant use of SUSTIVA and St. John's wort (Hypericum perforatum) or St. John's
wort-containing products is not recommended. Coadministration of non-nucleoside reverse transcriptase
inhibitors (NNRTIs), including SUSTIVA, with St. John's wort is expected to substantially decrease NNRTI
concentrations and may result in suboptimal levels of efavirenz and lead to loss of virologic response and
possible resistance to efavirenz or to the class of NNRTIs.
Reproductive Risk Potential: Pregnancy Category D. Efavirenz may cause fetal harm when administered
during the first trimester to a pregnant woman. Pregnancy should be avoided in women receiving SUSTIVA.
Barrier contraception should always be used in combination with other methods of contraception (eg, oral or
other hormonal contraceptives). Women of childbearing potential should undergo pregnancy testing before
initiation of SUSTIVA. If this drug is used during the first trimester of pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
There are no adequate and well-controlled studies in pregnant women. SUSTIVA should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus, such as in pregnant women
without other therapeutic options. As of July 2006, the Antiretroviral Pregnancy Registry has received
prospective reports of 322 pregnancies exposed to efavirenz-containing regimens, nearly all of which were
first-trimester exposures (316 pregnancies). Birth defects occurred in 6 of 255 live births (first-trimester
exposure) and 1 of 17 live births (second/third-trimester exposure). None of these prospectively reported
defects were neural tube defects. However, there have been four retrospective reports of findings consistent
with neural tube defects, including meningomyelocele. All mothers were exposed to efavirenz-containing
regimens in the first trimester. Although a causal relationship of these events to the use of SUSTIVA has not
been established, similar defects have been observed in preclinical studies of efavirenz.
Malformations have been observed in 3 of 20 fetuses/infants from efavirenz-treated cynomolgus monkeys
(versus 0 of 20 concomitant controls) in a developmental toxicity study. The pregnant monkeys were dosed
throughout pregnancy (postcoital days 20-150) with efavirenz 60 mg/kg daily, a dose which resulted in plasma
drug concentrations similar to those in humans given 600 mg/day of SUSTIVA. Anencephaly and unilateral
anophthalmia were observed in one fetus, microophthalmia was observed in another fetus, and cleft palate was
observed in a third fetus. Efavirenz crosses the placenta in cynomolgus monkeys and produces fetal blood
concentrations similar to maternal blood concentrations. Efavirenz has been shown to cross the placenta in rats
and rabbits and produces fetal blood concentrations of efavirenz similar to maternal concentrations. An
increase in fetal resorptions was observed in rats at efavirenz doses that produced peak plasma concentrations
and AUC values in female rats equivalent to or lower than those achieved in humans given 600 mg once daily
of SUSTIVA. Efavirenz produced no reproductive toxicities when given to pregnant rabbits at doses that
produced peak plasma concentrations similar to and AUC values approximately half of those achieved in
humans given 600 mg once daily of SUSTIVA.
Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to SUSTIVA, an
Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by
calling (800) 258-4263.
tions, about 50% to 60% have circulating CCR5-tropic HIV.
Vitamin D Enhances Immunity to TB
A single oral dose of 2.5 mg of vitamin D enhances antimycobacterial
immunity in healthy people who have
had contact with someone with
tuberculosis, according to a study in
the July 15 American Journal of
Respiratory and Critical Care
Medicine. The article notes that vitamin D was used to treat TB in the
“preantibiotic era.”
PRECAUTIONS
General - Skin Rash: In controlled clinical trials, 26% (266/1008) of patients treated with 600 mg
SUSTIVA (efavirenz) experienced new-onset skin rash compared with 17% (111/635) of patients treated in
control groups. Rash associated with blistering, moist desquamation, or ulceration occurred in 0.9% (9/1008)
of patients treated with SUSTIVA. The incidence of Grade 4 rash (eg, erythema multiforme, Stevens-Johnson
syndrome) in patients treated with SUSTIVA in all studies and expanded access was 0.1%. The median time to
onset of rash in adults was 11 days and the median duration, 16 days. The discontinuation rate for rash in
clinical trials was 1.7% (17/1008). SUSTIVA should be discontinued in patients developing severe rash
associated with blistering, desquamation, mucosal involvement, or fever. Appropriate antihistamines and/or
corticosteroids may improve the tolerability and hasten the resolution of rash.
Rash was reported in 26 of 57 pediatric patients (46%) treated with SUSTIVA capsules. One pediatric patient
experienced Grade 3 rash (confluent rash with fever), and two patients had Grade 4 rash (erythema multiforme).
The median time to onset of rash in pediatric patients was 8 days. Prophylaxis with appropriate antihistamines
prior to initiating therapy with SUSTIVA in pediatric patients should be considered (see ADVERSE REACTIONS).
Liver Enzymes: In patients with known or suspected history of hepatitis B or C infection and in patients treated
with other medications associated with liver toxicity, monitoring of liver enzymes is recommended. In patients
with persistent elevations of serum transaminases to greater than five times the upper limit of the normal
range, the benefit of continued therapy with SUSTIVA needs to be weighed against the unknown risks of
significant liver toxicity (see ADVERSE REACTIONS: Laboratory Abnormalities).
Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience
in patients with hepatic impairment, caution should be exercised in administering SUSTIVA to these patients.
Convulsions: Convulsions have been observed in patients receiving efavirenz, generally in the presence of
known medical history of seizures. Caution must be taken in any patient with a history of seizures. Patients who
are receiving concomitant anticonvulsant medications primarily metabolized by the liver, such as phenytoin and
phenobarbital, may require periodic monitoring of plasma levels (see PRECAUTIONS: Drug Interactions).
Animal toxicology: Nonsustained convulsions were observed in 6 of 20 monkeys receiving efavirenz at doses
yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose.
Cholesterol: Monitoring of cholesterol and triglycerides should be considered in patients treated with SUSTIVA
(see ADVERSE REACTIONS).
Fat Redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat
enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid
appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term
consequences of these events are currently unknown. A causal relationship has not been established.
Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated
with combination antiretroviral therapy, including SUSTIVA. During the initial phase of combination antiretroviral
treatment, patients whose immune system responds may develop an inflammatory response to indolent or
residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis
jiroveci pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Information for Patients: A statement to patients and healthcare providers is included on the product’s bottle
labels: ALERT: Find out about medicines that should NOT be taken with SUSTIVA. A Patient Package Insert
(PPI) for SUSTIVA is available for patient information.
Patients should be informed that SUSTIVA is not a cure for HIV-1 infection and that they may continue to
develop opportunistic infections and other complications associated with HIV-1 disease. Patients should be told
that there are currently no data demonstrating that SUSTIVA therapy can reduce the risk of transmitting HIV to
others through sexual contact or blood contamination.
Patients should be advised to take SUSTIVA every day as prescribed. SUSTIVA must always be used in
combination with other antiretroviral drugs. Patients should be advised to take SUSTIVA on an empty stomach,
preferably at bedtime. Taking SUSTIVA with food increases efavirenz concentrations and may increase the
frequency of adverse events. Dosing at bedtime may improve the tolerability of nervous system symptoms (see
ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION in Full Prescribing Information). Patients should
remain under the care of a physician while taking SUSTIVA.
Patients should be informed that central nervous system symptoms including dizziness, insomnia, impaired
concentration, drowsiness, and abnormal dreams are commonly reported during the first weeks of therapy with
SUSTIVA. Dosing at bedtime may improve the tolerability of these symptoms, and these symptoms are likely to
improve with continued therapy. Patients should be alerted to the potential for additive central nervous system
effects when SUSTIVA is used concomitantly with alcohol or psychoactive drugs. Patients should be instructed
that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or
operating machinery (see WARNINGS: Nervous System Symptoms). In clinical trials, patients who develop
central nervous system symptoms were not more likely to subsequently develop psychiatric symptoms (see
WARNINGS: Psychiatric Symptoms).
Patients should also be informed that serious psychiatric symptoms including severe depression, suicide
attempts, aggressive behavior, delusions, paranoia, and psychosis-like symptoms have also been reported in
patients receiving SUSTIVA. Patients should be informed that if they experience severe psychiatric adverse
experiences they should seek immediate medical evaluation to assess the possibility that the symptoms may
be related to the use of SUSTIVA, and if so, to determine whether discontinuation of SUSTIVA may be required.
Patients should also inform their physician of any history of mental illness or substance abuse (see WARNINGS:
Psychiatric Symptoms).
Patients should be informed that another common side effect is rash. These rashes usually go away without
any change in treatment. In a small number of patients, rash may be serious. Patients should be advised that
they should contact their physician promptly if they develop a rash.
Women receiving SUSTIVA should be instructed to avoid pregnancy (see WARNINGS: Reproductive Risk
Potential). A reliable form of barrier contraception should always be used in combination with other methods
of contraception, including oral or other hormonal contraception, because the effects of efavirenz on hormonal
contraceptives are not fully characterized. Women should be advised to notify their physician if they become
pregnant while taking SUSTIVA. If this drug is used during the first trimester of pregnancy, or if the patient
becomes pregnant while taking this drug, she should be apprised of the potential harm to the fetus.
SUSTIVA may interact with some drugs; therefore, patients should be advised to report to their doctor the use
of any other prescription, nonprescription medication, or herbal products, particularly St. John's wort.
Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving
antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this
time.
Drug Interactions (see also CONTRAINDICATIONS and CLINICAL PHARMACOLOGY: Drug Interactions in
Full Prescribing Information)
Efavirenz has been shown in vivo to induce CYP3A4. Other compounds that are substrates of CYP3A4 may have
decreased plasma concentrations when coadministered with SUSTIVA. In vitro studies have demonstrated that
efavirenz inhibits 2C9, 2C19, and 3A4 isozymes in the range of observed efavirenz plasma concentrations.
Coadministration of efavirenz with drugs primarily metabolized by these isozymes may result in altered plasma
concentrations of the coadministered drug. Therefore, appropriate dose adjustments may be necessary for
these drugs.
Drugs which induce CYP3A4 activity (eg, phenobarbital, rifampin, rifabutin) would be expected to increase the
clearance of efavirenz resulting in lowered plasma concentrations. Drug interactions with SUSTIVA are
summarized in Tables 1 and 2. The tables include potentially significant interactions, but are not all inclusive.
Table 1: Drugs That Are Contraindicated or Not Recommended for Use With SUSTIVA
Drug Class: Drug Name
Antifungal: voriconazole
Clinical Comment
CONTRAINDICATED at standard doses. SUSTIVA significantly decreases
voriconazole plasma concentrations, and coadministration may decrease the
therapeutic effectiveness of voriconazole. Also, voriconazole significantly
increases SUSTIVA plasma concentrations, which may increase the risk of
SUSTIVA-associated side effects. When voriconazole is coadministered with
SUSTIVA, voriconazole maintenance dose should be increased to 400 mg every
12 hours and SUSTIVA dose should be decreased to 300 mg once daily using
the capsule formulation. SUSTIVA tablets should not be broken. (See CLINICAL
PHARMACOLOGY, Tables 1 and 2 in Full Prescribing Information;
CONTRAINDICATIONS; and DOSAGE AND ADMINISTRATION: Dosage
Adjustment in Full Prescribing Information.)
(continued)
www.ncchc.org
Empathy: How Do Correctional Docs Measure Up?
Empathy is an important factor in
good physician-patient relations. It
contributes to patient satisfaction,
but even more fundamentally, it can
help a physician to get an adequate
history and it can motivate patients
to adhere to their treatments.
Recognizing that the correctional
environment subjects physicians and
patients alike to “unique stressors,”
researchers from the University of
California sought to determine
whether correctional physicians differed from those in the community
in their levels and expression of
empathy.
In an exploratory study, they surveyed correctional and noncorrectional physicians in California using
a modified version of the Interpersonal Reactivity Index. Questionnaires were returned from 42 doctors who work in prisons or jails, of
whom 20 work exclusively in such
settings, and 36 who work solely with
noncorrectional patients.
The construct of “empathy” was
divided into four subcomponents:
emotional resonance, intrinsic
curiosity, toleration of emotional
ambivalence and compassion.
The study results are reported in
Table 1: Drugs That Are Contraindicated or Not Recommended for Use With SUSTIVA (efavirenz) (continued)
Drug Class: Drug Name
Clinical Comment
Antihistamine: astemizole
CONTRAINDICATED due to potential for serious and/or life-threatening
reactions such as cardiac arrhythmias.
Antimigraine: ergot derivatives
CONTRAINDICATED due to potential for serious and/or life-threatening
(dihydroergotamine, ergonovine, reactions such as acute ergot toxicity characterized by peripheral vasospasm
ergotamine, methylergonovine) and ischemia of the extremities and other tissues.
Benzodiazepines: midazolam,
CONTRAINDICATED due to potential for serious and/or life-threatening
triazolam
reactions such as prolonged or increased sedation or respiratory depression.
Calcium channel blocker: bepridil CONTRAINDICATED due to potential for serious and/or life-threatening
reactions such as cardiac arrhythmias.
GI motility agent: cisapride
CONTRAINDICATED due to potential for serious and/or life-threatening
reactions such as cardiac arrhythmias.
Neuroleptic: pimozide
CONTRAINDICATED due to potential for serious and/or life-threatening
reactions such as cardiac arrhythmias.
NOT RECOMMENDED: Expected to substantially decrease plasma levels of
St. John’s wort (Hypericum
perforatum)
efavirenz; has not been studied in combination with SUSTIVA.
Table 2: Establisheda and Other Potentially Significantb Drug Interactions: Alteration in Dose or Regimen May
Be Recommended Based on Drug Interaction Studies or Predicted Interaction
Effect on
Concomitant
Concentration of
Drug Class:
SUSTIVA or
Drug Name
Concomitant Drug
Clinical Comment
Antiretroviral agents
Protease inhibitor:
SUSTIVA has the potential to decrease serum concentrations
Amprenavir
? amprenavir
of amprenavir.
Protease inhibitor:
Fosamprenavir (unboosted): Appropriate doses of the
Fosamprenavir
? amprenavir
combinations with respect to safety and efficacy have not been
calcium
established.
Fosamprenavir/ritonavir: An additional 100 mg/day (300 mg total)
of ritonavir is recommended when SUSTIVA is administered with
fosamprenavir/ritonavir once daily. No change in the ritonavir
dose is required when SUSTIVA is administered with fosamprenavir plus ritonavir twice daily.
Protease inhibitor:
When coadministered with SUSTIVA in treatment-naive patients,
the recommended dose of atazanavir is 300 mg with ritonavir
Atazanavir
? atazanavira
100 mg and SUSTIVA 600 mg (all once daily). Dosing recommendations for SUSTIVA and atazanavir in treatment-experienced
patients have not been established.
Protease inhibitor:
The optimal dose of indinavir, when given in combination with
SUSTIVA, is not known. Increasing the indinavir dose to 1000 mg
Indinavir
? indinavira
every 8 hours does not compensate for the increased indinavir
metabolism due to SUSTIVA. When indinavir at an increased dose
(1000 mg every 8 hours) was given with SUSTIVA (600 mg once
daily), the indinavir AUC and Cmin were decreased on average by
33-46% and 39-57%, respectively, compared to when indinavir
(800 mg every 8 hours) was given alone.
Protease inhibitor:
Lopinavir/ritonavir tablets should not be administered oncedaily in combination with SUSTIVA. In antiretroviral-naive
Lopinavir/
? lopinavira
ritonavir
patients, lopinavir/ritonavir tablets can be used twice daily
in combination with SUSTIVA with no dose adjustment. A
dose increase of lopinavir/ritonavir tablets to 600/150 mg
(3 tablets) twice daily may be considered when used in
combination with SUSTIVA in treatment-experienced patients
where decreased susceptibility to lopinavir is clinically suspected
(by treatment history or laboratory evidence). A dose increase of
lopinavir/ritonavir oral solution to 533/133 mg (6.5 mL) twice
daily taken with food is recommended when used in combination
with SUSTIVA.
Protease inhibitor:
When ritonavir 500 mg q12h was coadministered with
SUSTIVA 600 mg once daily, the combination was associated
Ritonavir
B ritonavira
with a higher frequency of adverse clinical experiences
B efavirenza
(eg, dizziness, nausea, paresthesia) and laboratory abnormalities
(elevated liver enzymes). Monitoring of liver enzymes is recommended
when SUSTIVA is used in combination with ritonavir.
Protease inhibitor:
Should not be used as sole protease inhibitor in
combination with SUSTIVA.
Saquinavir
? saquinavira
Other agents
Anticoagulant:
Plasma concentrations and effects potentially increased
Warfarin
B or ? warfarin
or decreased by SUSTIVA.
Anticonvulsants:
There are insufficient data to make a dose
recommendation for efavirenz. Alternative anticonvulsant
Carbamazepine
? carbamazepinea
treatment should be used.
? efavirenza
Phenytoin
Phenobarbital
Antidepressant:
Sertraline
Antifungals:
Itraconazole
Ketoconazole
Anti-infective:
Clarithromycin
? anticonvulsant
? efavirenz
? sertralinea
? itraconazolea
? hydroxyitraconazolea
? ketoconazole
? clarithromycina
B 14-OH metabolitea
Antimycobacterial:
Rifabutin
www.ncchc.org
? rifabutina
Potential for reduction in anticonvulsant and/or efavirenz
plasma levels; periodic monitoring of anticonvulsant plasma
levels should be conducted.
Increases in sertraline dose should be guided by
clinical response.
Since no dose recommendation for itraconazole can be
made, alternative antifungal treatment should be
considered.
Drug interaction studies with SUSTIVA and ketoconazole have not
been conducted. SUSTIVA has the potential to decrease plasma
concentrations of ketoconazole. (See Table 1 for guidance on
coadministration with adjusted doses of voriconazole.)
Plasma concentrations decreased by SUSTIVA; clinical
significance unknown. In uninfected volunteers, 46%
developed rash while receiving SUSTIVA and clarithromycin.
No dose adjustment of SUSTIVA is recommended when given
with clarithromycin. Alternatives to clarithromycin, such as
azithromycin, should be considered (see Other Drugs, following
table). Other macrolide antibiotics, such as erythromycin, have
not been studied in combination with SUSTIVA.
Increase daily dose of rifabutin by 50%. Consider doubling the
rifabutin dose in regimens where rifabutin is given 2 or 3 times
a week.
(continued)
the latest issue of the Journal of
Correctional Health Care (see issue
information below).
Similar, Yet Different
For the most part, the two groups
were found to be similar in their
responses, with both displaying
empathy and compassion. But the
researchers did detect differences.
Correctional physicians reported
greater satisfaction with their work,
but the study points out that this
satisfaction from work may or may
not reflect empathy.
Findings suggest that “Correc-
Table 2: Establisheda and Other Potentially Significantb Drug Interactions: Alteration in Dose or Regimen May
Be Recommended Based on Drug Interaction Studies or Predicted Interaction
(continued)
Effect on
Concomitant
Concentration of
Drug Class:
SUSTIVA (efavirenz)
Drug Name
or Concomitant Drug Clinical Comment
Other agents (continued)
Antimycobacterial:
? efavirenza
Clinical significance of reduced efavirenz concentrations
Rifampin
is unknown. Dosing recommendations for concomitant use
of SUSTIVA and rifampin have not been established.
Calcium channel blockers:
Diltiazem dose adjustments should be guided by clinical
Diltiazem
? diltiazema
? desacetyl diltiazema response (refer to the complete prescribing information for
? N-monodesmethyl diltiazem). No dose adjustment of efavirenz is necessary
diltiazema
when administered with diltiazem.
Others (eg, felodipine,
nicardipine, nifedipine,
verapamil)
HMG-CoA reductase
inhibitors:
Atorvastatin
Pravastatin
Simvastatin
Narcotic analgesic:
Methadone
? calcium
channel
blocker
? atorvastatina
? pravastatina
? simvastatina
No data are available on the potential interactions of
efavirenz with other calcium channel blockers that are
substrates of the CYP3A4 enzyme. The potential exists for
reduction in plasma concentrations of the calcium channel
blocker. Dose adjustments should be guided by clinical response
(refer to the complete prescribing information for the calcium
channel blocker).
Plasma concentrations of atorvastatin, pravastatin,
and simvastatin decreased. Consult the complete
prescribing information for the HMG-CoA reductase
inhibitor for guidance on individualizing the dose.
Coadministration in HIV-infected individuals with a history of
injection drug use resulted in decreased plasma levels of
methadone and signs of opiate withdrawal. Methadone dose was
increased by a mean of 22% to alleviate withdrawal symptoms.
Patients should be monitored for signs of withdrawal and their
methadone dose increased as required to alleviate withdrawal
symptoms.
Oral contraceptive:
Plasma concentrations increased by SUSTIVA; clinical
a
Ethinyl estradiol
B ethinyl estradiol
significance unknown. The potential interaction of efavirenz with
oral contraceptives has not been fully characterized. A reliable
method of barrier contraception should be used in addition to oral
contraceptives.
a See CLINICAL PHARMACOLOGY, Tables 1 and 2 in Full Prescribing Information for magnitude of established interactions. b This table is not all-inclusive.
? methadonea
Other Drugs: Based on the results of drug interaction studies (see Tables 1 and 2 in Full Prescribing
Information), no dosage adjustment is recommended when SUSTIVA (efavirenz) is given with the following:
aluminum/magnesium hydroxide antacids, azithromycin, cetirizine, famotidine, fluconazole, lamivudine,
lorazepam, nelfinavir, paroxetine, tenofovir disoproxil fumarate, and zidovudine.
Specific drug interaction studies have not been performed with SUSTIVA and NRTIs other than lamivudine and
zidovudine. Clinically significant interactions would not be expected since the NRTIs are metabolized via a
different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and
elimination pathways.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term carcinogenicity studies in mice and rats were carried out with efavirenz. Mice were dosed with 0,
25, 75, 150, or 300 mg/kg/day for 2 years. Incidences of hepatocellular adenomas and carcinomas and
pulmonary alveolar/ bronchiolar adenomas were increased above background in females. No increases in
tumor incidence above background were seen in males. In studies in which rats were administered efavirenz
at doses of 0, 25, 50, or 100 mg/kg/day for 2 years, no increases in tumor incidence above background were
observed. The systemic exposure (based on AUCs) in mice was approximately 1.7-fold that in humans receiving
the 600-mg/day dose. The exposure in rats was lower than that in humans. The mechanism of the carcinogenic
potential is unknown. However, in genetic toxicology assays, efavirenz showed no evidence of mutagenic or
clastogenic activity in a battery of in vitro and in vivo studies. These included bacterial mutation assays in S.
typhimurium and E. coli, mammalian mutation assays in Chinese hamster ovary cells, chromosome aberration
assays in human peripheral blood lymphocytes or Chinese hamster ovary cells, and an in vivo mouse bone
marrow micronucleus assay. Given the lack of genotoxic activity of efavirenz, the relevance to humans of
neoplasms in efavirenz-treated mice is not known.
Efavirenz did not impair mating or fertility of male or female rats, and did not affect sperm of treated male
rats. The reproductive performance of offspring born to female rats given efavirenz was not affected. As a result
of the rapid clearance of efavirenz in rats, systemic drug exposures achieved in these studies were equivalent
to or below those achieved in humans given therapeutic doses of efavirenz.
Pregnancy
Pregnancy Category D
See WARNINGS: Reproductive Risk Potential.
Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-infected mothers
not breast-feed their infants to avoid risking postnatal transmission of HIV. Although it is not known if
efavirenz is secreted in human milk, efavirenz is secreted into the milk of lactating rats. Because of the potential
for HIV transmission and the potential for serious adverse effects in nursing infants, mothers should be
instructed not to breast-feed if they are receiving SUSTIVA.
Pediatric Use: ACTG 382 is an ongoing, open-label study in 57 NRTI-experienced pediatric patients to
characterize the safety, pharmacokinetics, and antiviral activity of SUSTIVA in combination with nelfinavir
(20-30 mg/kg TID) and NRTIs. Mean age was 8 years (range 3-16). SUSTIVA has not been studied in pediatric
patients below 3 years of age or who weigh less than 13 kg. At 48 weeks, the type and frequency of adverse
experiences was generally similar to that of adult patients with the exception of a higher incidence of rash,
which was reported in 46% (26/57) of pediatric patients compared to 26% of adults, and a higher frequency of
Grade 3 or 4 rash reported in 5% (3/57) of pediatric patients compared to 0.9% of adults (see ADVERSE
REACTIONS, Table 4).
The starting dose of SUSTIVA was 600 mg once daily adjusted to body size, based on weight, targeting AUC
levels in the range of 190-380 µM•h. The pharmacokinetics of efavirenz in pediatric patients were similar to
the pharmacokinetics in adults who received 600-mg daily doses of SUSTIVA. In 48 pediatric patients receiving
the equivalent of a 600-mg dose of SUSTIVA, steady-state Cmax was 14.2 ± 5.8 µM (mean ± SD), steady-state
Cmin was 5.6 ± 4.1 µM, and AUC was 218 ± 104 µM•h.
Geriatric Use: Clinical studies of SUSTIVA did not include sufficient numbers of subjects aged 65 years and
over to determine whether they respond differently from younger subjects. In general, dose selection for an
elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac
function and of concomitant disease or other therapy.
ADVERSE REACTIONS
The most significant adverse events observed in patients treated with SUSTIVA are nervous system symptoms,
psychiatric symptoms, and rash. Unless otherwise specified, the analyses described below included 1008
patients treated with regimens containing SUSTIVA and 635 patients treated with a control regimen in
controlled trials.
Nervous System Symptoms: Fifty-three percent of patients receiving SUSTIVA reported central nervous system
symptoms (see WARNINGS: Nervous System Symptoms). Table 3 lists the frequency of the symptoms of
different degrees of severity and gives the discontinuation rates in clinical trials for one or more of the following
nervous system symptoms: dizziness, insomnia, impaired concentration, somnolence, abnormal dreaming,
tional physicians may not be as emotionally attuned to their patients and
may display less curiosity about their
feelings. Therefore, their work satisfaction may not be derived from the
interpersonal component of medical
care.”
That said, some correctional physicians interviewed during the study’s
preliminary field work described a
“developmental course in which they
become increasingly able to empathize with inmates.... These physicians initially experienced discomfort when working with inmatepatients and their preexisting prejudices were reflected in their practice,
but they eventually learned to deal
with them.” They said they gained
greater empathy after many years of
listening to their patients’ life stories and problems.
JCHC Volume 13, Issue 4
• Readers Write: Insights From
Practicing Correctional Health
Professionals. When is a decision
not to treat the right choice?
• The Role of Cognition, Impulsivity, and Age in Program
Violations in a Federal Prison
Substance Abuse Treatment
Facility: A Preliminary Report —
Scott Salvatore, PsyD, David A.
Smelson, PsyD, Anna Kline, PhD,
Bradley Sussner, PhD, Erik
Faust, PhD, Seung Min Lee
• Physician Empathy and Compassion for Inmate-Patients in the
Correctional Health Care Setting
— Naveen Dhawan, Alan B.
Steinbach, PhD, MD, Jodi
Halpern, MD, PhD
• Incidence and Practical Issues of
Mental Health for School-Aged
Youth in Juvenile Justice
Detention — Steven Osterlind,
PhD, James Koller, PhD, Edwin
Morris, PhD
• The Prevalence of HIV Peer
Programming in American
Prisons: An Opportunity Wasted
— Kimberly Collica, PhD
• Methicillin-Resistant Staphylococcus aureus Nasal Carriage
Rate in Texas County Jail Inmates
— Marilyn Felkner, DrPH,
Rodney E. Rohde, MS, Ana Maria
Valle-Rivera, PhD, Tamara
Baldwin, L.P. (Sky) Newsome
• Participative Planning to Enhance
Inmate Wellness: Preliminary
Report of a Correctional Wellness Program — Philip R. Curd,
MD, MSPH, Sandra J. Winter,
MHA, Alison Connell, MSN
Each issue of JCHC also has a selfstudy exam by which physicians,
nurses, psychologists and CCHPs
may earn CE credit. To subscribe,
contact Sage Publications:
800-818-7243, ext. 7100
[email protected]
http://jchc.sagepub.com
SUMMER 2007 • CorrectCare 19
HUMAN CAPITAL
(continued from page 1)
prevention). In 2007, we added basic
computer skills to enable the students to complete their competency
tests.
Upon completion of the program,
the psychiatric aide demonstrates
proficiency in select clinical skills
and takes a written exam administered by an RN examiner to become
certified as a nurse assistant.
Positive Outcomes
By June 2007, 19 psychiatric aides
had completed the training program.
The results of a post-training survey
showed that 100% of the aides rated
the experience as excellent, and
many commented that they learned
a lot and that their job performance
had improved. The director of nursing
noticed improvements in the aides’
skills and their ability to identify
changes in client conditions before
physical and/or mental decline.
Besides enhancing competency—
and morale—these newly learned
portable skills enable the aides to
earn extra money by moonlighting as
a CNA, one of Missouri’s fastest
growing occupations.
Recently, after examining her first
group of CNA candidates from
SLPRC, one RN examiner said, “This
is the best group I’ve ever seen …
euphoria, confusion, agitation, amnesia, hallucinations, stupor, abnormal thinking, and depersonalization.
The frequencies of specific central and peripheral nervous system symptoms are provided in Table 5.
Table 3: Percent of Patients with One or More Selected Nervous System Symptomsa,b
Percent of Patients with:
SUSTIVA 600 mg Once Daily (n=1008)
Control Groups (n=635)
%
%
Symptoms of any severity
52.7
24.6
c
Mild symptoms
33.3
15.6
Moderate symptomsd
17.4
7.7
Severe symptomse
2.0
1.3
Treatment discontinuation
2.1
1.1
as a result of symptoms
a Includes events reported regardless of causality. b Data from Study 006 and three Phase 2/3 studies.
c “Mild” = Symptoms which do not interfere with patient’s daily activities. d “Moderate” = Symptoms which may
interfere with daily activities. e “Severe” = Events which interrupt patient’s usual daily activities.
Psychiatric Symptoms: Serious psychiatric adverse experiences have been reported in patients treated with
SUSTIVA (efavirenz). In controlled trials, the frequency of specific serious psychiatric symptoms among patients who
received SUSTIVA or control regimens, respectively, were severe depression (2.4%, 0.9%), suicidal ideation (0.7%,
0.3%), nonfatal suicide attempts (0.5%, 0), aggressive behavior (0.4%, 0.5%), paranoid reactions (0.4%, 0.3%), and
manic reactions (0.2%, 0.3%) (see WARNINGS: Psychiatric Symptoms). Additional psychiatric symptoms
observed at a frequency of >2% among patients treated with SUSTIVA or control regimens, respectively, in
controlled clinical trials were depression (19%, 16%), anxiety (13%, 9%), and nervousness (7%, 2%).
Skin Rash: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 2
weeks of initiating therapy with SUSTIVA. In most patients, rash resolves with continuing SUSTIVA therapy
within one month. SUSTIVA can be reinitiated in patients interrupting therapy because of rash. Use of
appropriate antihistamines and/or corticosteroids may be considered when SUSTIVA is restarted. SUSTIVA
should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal
involvement, or fever. The frequency of rash by NCI grade and the discontinuation rates as a result of rash are
provided in Table 4.
Table 4: Percent of Patients with Treatment-Emergent Rasha,b
Percent of
Patients with:
Rash of any grade
Grade 1 rash
Grade 2 rash
Grade 3 rash
Grade 4 rash
Description of
Rash Gradec
–
Erythema, pruritus
Diffuse
maculopapular rash,
dry desquamation
Vesiculation, moist
desquamation, ulceration
Erythema multiforme,
Stevens-Johnson syndrome,
toxic epidermal necrolysis,
necrosis requiring surgery,
exfoliative dermatitis
Treatment discontinuation
as a result of rash
–
a Includes events reported regardless of causality.
b
SUSTIVA 600 mg
Once Daily Adults
(n=1008)
%
26.3
10.7
SUSTIVA
Pediatric Patients
(n=57)
%
45.6
8.8
Control
Groups Adults
(n=635)
%
17.5
9.8
14.7
31.6
7.4
0.8
1.8
0.3
0.1
3.5
0.0
1.7
8.8
0.3
Data from Study 006 and three Phase 2/3 studies. c NCI Grading System.
As seen in Table 4, rash is more common in pediatric patients and more often of higher grade (ie, more severe)
(see PRECAUTIONS: General).
Experience with SUSTIVA in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Nineteen patients who discontinued nevirapine because of rash have been treated with SUSTIVA. Nine of these
patients developed mild-to-moderate rash while receiving therapy with SUSTIVA, and two of these patients
discontinued because of rash.
Pancreatitis has been reported, although a causal relationship with efavirenz has not been established.
Asymptomatic increases in serum amylase levels were observed in a significantly higher number of patients
treated with efavirenz 600 mg than in control patients (see ADVERSE REACTIONS: Laboratory
Abnormalities).
Selected clinical adverse experiences of moderate or severe intensity observed in *2% of SUSTIVA-treated
patients in two controlled clinical trials are presented in Table 5.
Table 5: Selected Treatment-Emergenta Adverse Events of Moderate or Severe Intensity Reported in *2% of SUSTIVATreated Patients in Studies 006 and ACTG 364
Adverse Events
Study 006
Study ACTG 364
LAM-, NNRTI-, and Protease
NRTI-experienced, NNRTI- and
Inhibitor-Naive Patients
Protease Inhibitor-Naive Patients
SUSTIVAb
SUSTIVAb
Indinavir
SUSTIVAb
SUSTIVAb
Nelfinavir
+
+
+
+ Nelfinavir
+
+
ZDV/LAM
Indinavir
ZDV/LAM
+ NRTIs
NRTIs
NRTIs
(n=412)
(n=415)
(n=401)
(n=64)
(n=65)
(n=66)
180 weeksc 102 weeksc
76 weeksc
71.1 weeksc 70.9 weeksc 62.7 weeksc
Body as a Whole
Fatigue
8%
5%
9%
0
2%
3%
Pain
1%
2%
8%
13%
6%
17%
Central and Peripheral Nervous System
Dizziness
9%
9%
2%
2%
6%
6%
Headache
8%
5%
3%
5%
2%
3%
Insomnia
7%
7%
2%
0
0
2%
Concentration
5%
3%
<1%
0
0
0
impaired
Abnormal dreams
3%
1%
0
—
—
—
Somnolence
2%
2%
<1%
0
0
0
Anorexia
1%
<1%
<1%
0
2%
2%
Gastrointestinal
Nausea
10%
6%
24%
3%
2%
2%
Vomiting
6%
3%
14%
—
—
—
Diarrhea
3%
5%
6%
14%
3%
9%
Dyspepsia
4%
4%
6%
0
0
2%
Abdominal pain
2%
2%
5%
3%
3%
3%
Psychiatric
Anxiety
2%
4%
<1%
—
—
—
Depression
5%
4%
<1%
3%
0
5%
Nervousness
2%
2%
0
2%
0
2%
Skin & Appendages
Rash
11%
16%
5%
9%
5%
9%
Pruritus
<1%
1%
1%
9%
5%
9%
a Includes adverse events at least possibly related to study drug or of unknown relationship for Study 006. Includes all adverse
events regardless of relationship to study drug for Study ACTG 364. b SUSTIVA provided as 600 mg once daily.
c Median duration of treatment. — = Not Specified. ZDV = zidovudine, LAM = lamivudine.
20 SUMMER 2007 • CorrectCare
Facility and Client Profile
they’re so organized and meticulous
… I’m really impressed! They should
be in nursing school.”
Bright Prospects
The post-training surveys of the new
CNAs showed that 58% planned to
further their education in the field of
nursing and 74% planned to remain
with SLPRC until retirement. Based
on the training they’ve already
received, it would be a seamless transition for these aides to integrate
into the nursing field since the seed
for continuous learning has been
planted. In fact, internal SLPRC policies are already in place to provide
Clinical adverse experiences observed in *10% of 57 pediatric patients aged 3 to 16 years who received
SUSTIVA (efavirenz) capsules, nelfinavir, and one or more NRTIs were: rash (46%), diarrhea/loose stools (39%),
fever (21%), cough (16%), dizziness/lightheaded/fainting (16%), ache/pain/discomfort (14%), nausea/vomiting
(12%), and headache (11%). The incidence of nervous system symptoms was 18% (10/57). One patient
experienced Grade 3 rash, two patients had Grade 4 rash, and five patients (9%) discontinued because of rash
(see also PRECAUTIONS: Skin Rash and Pediatric Use).
Postmarketing Experience
Body as a Whole: allergic reactions, asthenia, redistribution/accumulation of body fat (see PRECAUTIONS: Fat
Redistribution)
Central and Peripheral Nervous System: abnormal coordination, ataxia, convulsions, hypoesthesia,
paresthesia, neuropathy, tremor
Endocrine: gynecomastia
Gastrointestinal: constipation, malabsorption
Cardiovascular: flushing, palpitations
Liver and Biliary System: hepatic enzyme increase, hepatic failure, hepatitis
Metabolic and Nutritional: hypercholesterolemia, hypertriglyceridemia
Musculoskeletal: arthralgia, myalgia, myopathy
Psychiatric: aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis,
suicide
Respiratory: dyspnea
Skin and Appendages: erythema multiforme, nail disorders, photoallergic dermatitis, skin discoloration,
Stevens-Johnson syndrome
Special Senses: abnormal vision, tinnitus
Laboratory Abnormalities: Selected Grade 3-4 laboratory abnormalities reported in *2% of SUSTIVA-treated
patients in two clinical trials are presented in Table 6.
Table 6: Selected Grade 3-4 Laboratory Abnormalities Reported in *2% of SUSTIVA-Treated Patients in Studies 006
and ACTG 364
Study 006
Study ACTG 364
LAM-, NNRTI-, and
NRTI-experienced, NNRTI- and
Protease Inhibitor-Naive Patients
Protease Inhibitor-Naive Patients
SUSTIVAa
SUSTIVAa Indinavir
SUSTIVAa
SUSTIVAa
Nelfinavir
+ ZDV/LAM + Indinavir + ZDV/LAM + Nelfinavir+NRTIs + NRTIs
+ NRTIs
(n=412)
(n=415)
(n=401)
(n=64)
(n=65)
(n=66)
b
b
b
b
b
Variable
Limit
180 weeks 102 weeks 76 weeks
71.1 weeks
70.9 weeks 62.7 weeksb
Chemistry
ALT
>5 x ULN
5%
8%
5%
2%
6%
3%
AST
>5 x ULN
5%
6%
5%
6%
8%
8%
>5 x ULN
8%
7%
3%
5%
0
5%
GGTc
Amylase
>2 x ULN
4%
4%
1%
0
6%
2%
Glucose
>250 mg/dL
3%
3%
3%
5%
2%
3%
9%
6%
6%
11%
8%
17%
Triglyceridesd *751 mg/dL
Hematology
Neutrophils <750/mm3
10%
3%
5%
2%
3%
2%
a SUSTIVA provided as 600 mg once daily. b Median duration of treatment. c Isolated elevations of GGT in patients
receiving SUSTIVA may reflect enzyme induction not associated with liver toxicity. d Nonfasting.
ZDV = zidovudine, LAM = lamivudine, ULN = Upper limit of normal, ALT = alanine aminotransferase,
AST = aspartate aminotransferase, GGT = gamma-glutamyltransferase.
Liver function tests should be monitored in patients with a history of hepatitis B and/or C. In the long-term
data set from Study 006, 137 patients treated with SUSTIVA-containing regimens (median duration of therapy,
68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening
for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive). Among these co-infected
patients, elevations in AST to greater than five times ULN developed in 13% of patients in the SUSTIVA arms
and 7% of those in the control arm, and elevations in ALT to greater than five times ULN developed in 20% of
patients in the SUSTIVA arms and 7% of patients in the control arm. Among co-infected patients, 3% of those
treated with SUSTIVA-containing regimens and 2% in the control arm discontinued from the study because of
liver or biliary system disorders (see PRECAUTIONS: General).
Lipids: Increases from baseline in total cholesterol of 10-20% have been observed in some uninfected
volunteers receiving SUSTIVA. In patients treated with SUSTIVA + zidovudine + lamivudine, increases from
baseline in nonfasting total cholesterol and HDL of approximately 20% and 25%, respectively, were observed.
In patients treated with SUSTIVA + indinavir, increases from baseline in nonfasting cholesterol and HDL of
approximately 40% and 35%, respectively, were observed. Nonfasting total cholesterol levels *240 mg/dL and
*300 mg/dL were reported in 34% and 9%, respectively, of patients treated with SUSTIVA + zidovudine +
lamivudine; 54% and 20%, respectively, of patients treated with SUSTIVA + indinavir; and 28% and 4%,
respectively, of patients treated with indinavir + zidovudine + lamivudine. The effects of SUSTIVA on
triglycerides and LDL were not well characterized since samples were taken from nonfasting patients. The
clinical significance of these findings is unknown (see PRECAUTIONS: General).
Cannabinoid Test Interaction: Efavirenz does not bind to cannabinoid receptors. False-positive urine
cannabinoid test results have been observed in non-HIV-infected volunteers receiving SUSTIVA when the
Microgenics CEDIA® DAU Multi-Level THC assay was used for screening. Negative results were obtained when
more specific confirmatory testing was performed with gas chromatography/mass spectrometry.
Of the three assays analyzed (Microgenics CEDIA DAU Multi-Level THC assay, Cannabinoid Enzyme
Immunoassay [Diagnostic Reagents, Inc.], and AxSYM® Cannabinoid Assay), only the Microgenics CEDIA DAU
Multi-Level THC assay showed false-positive results. The other two assays provided true-negative results. The
effects of SUSTIVA on cannabinoid screening tests other than these three are unknown. The manufacturers of
cannabinoid assays should be contacted for additional information regarding the use of their assays with
patients receiving efavirenz.
OVERDOSAGE
Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One
patient experienced involuntary muscle contractions.
Treatment of overdose with SUSTIVA should consist of general supportive measures, including monitoring of
vital signs and observation of the patient’s clinical status. Administration of activated charcoal may be used to
aid removal of unabsorbed drug. There is no specific antidote for overdose with SUSTIVA. Since efavirenz is
highly protein bound, dialysis is unlikely to significantly remove the drug from blood.
Distributed by
SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. ATRIPLA is a trademark of
Bristol-Myers Squibb & Gilead Sciences, LLC. Other brands listed are the trademarks of their respective owners.
The St. Louis Psychiatric Rehabilitation Center is a 212-bed forensic
facility operated by the Missouri
Department of Mental Health. It is
accredited by the Joint Commission and certified by the Centers
for Medicare and Medicaid
Services. An intermediate and
long-term inpatient facility, SLPRC
treats adults with severe mental
illnesses, many of whom have been
involuntarily committed by the
court system.
In March 2007, an analysis of
client records revealed that the
average stay is six to seven years.
Crimes committed are diverse, but
at least 33% involved some type of
an assault. Demographically, 88%
of the clients were men and 32%
were in their 50s.
Nearly half (47%) were dually
diagnosed with schizophrenia and
substance abuse, and 32% have a
global assessment of functioning
(GAF) score from 41 to 50, which
denotes severe symptoms (e.g.,
suicidal ideation, severe obsessional rituals) or a serious impairment
in social, occupational or academic functioning.
Changing Client Physical Profiles
In comparing records of clients
discharged between 2000 and
2006 with those in March 2007,
the analysis showed that the current clients typically had more
medical diagnoses, especially
heart disease, diabetes, obesity
and other chronic conditions.
Overweight is worsened by the fact
that many of these patients get little exercise, and many take
antipsychotic drugs that cause
weight gain. Well over 50% of the
clients smoke cigarettes.
educational leave time and tuition
reimbursement, although these benefits are currently underused.
Other homegrown nursing solutions might include internal training
and use of certified medication technicians (who must first be CNAs), and
improved marketing of an already
generous state employee benefits
package to attract new nurses.
Clearly, in cultivating our psychiatric aides by giving them CNA training, our facility has enabled those
aides to better care for clients with
increasing skilled care needs. This
will help to relieve the burden on
licensed nursing staff to provide
skilled care.
It also improves the job prospects
of those who receive the training.
Most importantly, it prepares them
for further education in nursing that
will enhance their professional lives,
improve the care of our clients and
directly address our nursing shortage
by home-growing nurses from a pool
of dedicated and eager employees.
© Bristol-Myers Squibb Company 2007
Printed in USA
T4-B0001A-01-07
Revised January 2007
1212823A1
Gwen Boyd, BSN, MA, CCHP, is the
nurse educator at the St. Louis (MO)
Psychiatric Rehabilitation Center. She
may be reached by e-mail at
[email protected].
www.ncchc.org
Standards Q&A
Expert Advice on NCCHC Standards for Health Services
BY JUDITH A. STANLEY, MS, CCHP-A, AND
R. SCOTT CHAVEZ, PHD, MPA, CCHP-A
Forcing Psychotropic Medications
Q
When the physician writes
an order for forced psychotropic medication, often
the inmate is already in or
being placed in restraints, or, at a
minimum, being held by correctional
staff. Just as the shot is about to be
given, the inmate appears calm. Can
we force the medication? Also, the
psychiatrist usually orders a kind of
“cocktail,” which may be a mixture
of short- and long-term medications.
Should our nurses not administer the
shot because the inmate is “calm”
and the longer-acting medicine is a
therapeutic intervention?
A
Anyone know Solomon’s
phone number? Let’s start
with the intent of standard
I-02 Emergency Psychotropic
Medication: “...to have a protocol for
emergency situations when an
inmate is dangerous to self or others
due to a medical or mental illness
and when forced psychotropic medication may be used to prevent harm,
based on a physician’s order.”
This emergency intervention by
physician’s order is a therapeutic
intervention that is used when all
else fails. The longer effect of some
portion of the medication is a positive outcome for such interventions,
and medications are often chosen
precisely for this effect. If the inmate
can clinically tolerate it, such a 2/1
intervention can be the door that
opens the inmate to healing. The
nurses need to discuss the issues with
the ordering physician so they understand such orders. For example, at
staff meetings ask the psychiatrist to
explain the therapeutic effects. That
is why you consulted the psychiatrist
in the first place—for expertise in
safely calming an inmate.
The restraint is merely a temporary
calm in the storm; without the medications, you soon will be back where
you started. If the inmate appears
calm when you are ready to give the
injection, you certainly should ask if
he or she will take the medications
voluntarily. If the inmate says yes,
administer them with permission. If
not, then force it as the physician
ordered.
The whole intervention should be
done quickly and at the time the
inmate is upset; in fact, that is the
only time a physician can order such
an intervention. Usually, once the
medications take effect, the restraints
can be removed. The physician usually
writes the restraint order as “up to X
hours until in control.”
You can ask the physician to write
the injection order such that it’s up
www.ncchc.org
to the judgment of the staff that’s
about to give the med, but that
would lead me to wonder if you are
using the forced medication intervention too easily. Many inmates
requiring such intervention will fight
the restraints and the shot.
Fit for Confinement
Q
In talking with health staff at
the local hospital emergency
room, the question arose as
to whether there is a definition of “fit for confinement” that ER
physicians could refer to when deciding if an inmate can be cleared for a
jail. Can NCCHC help?
A
I assume this is a situation in
which an inmate was sent to
the ER for an evaluation for
a medical and/or mental
health problem, and the ER is trying
to decide if the inmate can be sent
back to the jail.
Your best bet is to consult NCCHC’s
Standards for Health Services in
Jails, specifically essential standards
J-A-01 Access to Care and J-E-02
Receiving Screening and important
standard J-D-05 Hospital and Specialty
Care. Here is a summary of how these
standards address your question.
Inmates have a constitutional right
to access to care for their significant
health problems. If the level of care
needed is not available at the facility,
inmates are to be treated in a setting
that can meet their specific health
needs, such as a community hospital
or ER, or perhaps a better equipped
(i.e., health staff and services) correctional facility with which the original
facility has transfer arrangements.
The ER physician involved in deciding if the inmate can be appropriately
treated at the jail must consider several things. Foremost is the level of
health or mental health services
needed for follow-up if the inmatepatient is released, and whether the
available jail health resources are at
that level.
Sometimes when opinions differ
between community ER physicians
and jail physicians, it is because the
ER physician does not really know
what is available at the jail. A visit to
the jail and an exchange of information about its health staffing and
capabilities are essential to good
planning between jail and ER health
administrators and physicians.
One way for the ER physician to
think about a return to jail is to
regard it as a return to home care.
That is, if the inmate were a regular
community patient with a home and
minimally supportive situation,
would the hospital send the patient
home? Does the inmate-patient simply need observation that could be
done by minimally trained correctional officers, or does he or she
Judith A. Stanley
R. Scott Chavez
inmate-patient need nursing care
that is (or is not) available on-site? If
the jail has an infirmary, what scope
of care is available? Is there a shelJudith A. Stanley, MS, CCHP-A, is
tered housing area where the inmate
NCCHC’s director of accreditation
can receive the necessary services?
and oversees the development and
For example, is there a negative-presrevision of standards. R. Scott Chavez,
sure room to house contagious TB
PhD, MPA, CCHP-A, is NCCHC’s vice
patients, or does the patient need to
president and liaison to the policy
stay at the hospital until the contaand standards committee.
gious phase has passed?
Send your question to Standards
Some ER physicians mistakenly
Q&A, c/o NCCHC, 1145 W. Diversey
assume that jails have 24/7 health
Parkway, Chicago, IL 60614; e-mail
staff and supports. While that may be
[email protected]; fax 773-880-2424.
true in a few jails, particularly in the
mega-systems, most have limited onsite health resources. On the other
‘Spotlight’ Archives
hand, if you or I were treated in an
Available Online
ER and then sent home and not hospitalized, jails should expect that the
If you rely on the NCCHC
ER will want to do the same for
Standards for Health Services,
inmate-patients treated for the same
these CORRECTCARE articles
conditions.
will aid your understanding of
Given the possibility that little
selected standards in the latest
attention may be given to a returneditions. But you need not dig
ing inmate, the ERs may be advised
through
stacks of newspapers
to hold the inmate-patient for a little
to
find
them: The series is
longer observation if there is any
posted at our Web site.
doubt. Some jails and ERs create a
www.ncchc.org/resources
“locked ward” at the hospital when
Faces
4.75x6.75.qxp
3/27/2007 1:40 PM Page 1
such
patient
volume is high.
[ETHICAL. PROFESSIONAL. CARING.]
“THANK YOU FROM
A PATIENT IS ENOUGH.”
Shawn supervises care for
2,100 jail inmates, and
says her reward is a job
well done. She’s the kind
of professional you find at
Prison Health Services.
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With more than 28 years
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SUMMER 2007 • CorrectCare 21
Exhibitor Opportunity
About CorrectCare™
Updates in Correctional Health Care
San Antonio, Texas • May 17-20, 2008
High Quality Contacts
Who Should Exhibit?
If you want to rub elbows with the leaders in this field, your
company needs to exhibit at Updates 2008. This meeting
consistently attracts the best and brightest in correctional
health care, professionals who care about their jobs and
want to know how they can improve service delivery in
their institutions. In other words, they want to know what
you have to offer. Don’t miss this chance to make connections, stand out from your competitors and increase your
company’s presence with this influential audience.
associations; consultants; contract management; dental
supplies/equipment; diagnostic equipment; educational
materials/training; emergency preparation; EMR/health
records; infection control; info tech/software; medical
devices/equipment/supplies; pharmaceuticals and pharmacy services; publications; recruitment/staffing; suicide
prevention; uniforms/scrubs; universities
Exhibitor Benefits
• 1,000 high-quality attendees: These professionals are
looking for solutions to the challenges they face.
• Premier educational programming: Share in the success
of a proven winner.
• Exclusive exhibit hall hours: Develop valuable prospects
and reconnect with customers through one-on-one networking during three days of scheduled activities and
breaks (Sunday evening through Tuesday at noon).
• Long-term benefits: Your company will receive a free listing in NCCHC’s exciting new online Buyers Guide.
Other benefits include the following:
• 75-word listing in the final program (deadline applies)
• Electronic attendee registration list for pre- and postshow marketing
• Opportunity to add a marketing giveaway to the conference attendee bags
• Exclusive opportunity to participate in raffle drawings
• Ability to raise visibility by sponsoring NCCHC activities
• Special advertising discounts for CORRECTCARE and the
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• Priority booth selection for the 2008 National Conference on Correctional Health Care in Chicago
22 SUMMER 2007 • CorrectCare
Sponsorship Opportunities
Pump up your presence and maximize marketing dollars
through these outstanding sponsorship opportunities.
Premier Educational Programming: Sponsorship of
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Proceedings Manual: Distributed in popular CD format,
the manual provides a lasting record of each concurrent
session, including abstracts, handouts and PowerPoints.
The sponsor will be acknowledged on the CD cover.
The Internet Cafe: Enjoy a high-tech presence by sponsoring the exhibit hall computer stations, where attendees gather to check e-mail and browse the Web.
Exhibit Hall Reception/Luncheon/Breaks: These scheduled events enable attendees to meet with exhibitors and
network with colleagues while enjoying refreshments.
Other Opportunities: Registration bags, lanyards, cups,
badges, banners—all are good ways to boost visibility.
Registration Information
10' x 10' booths start at $1,100. Double-size and premium
spaces are available. Prices include one full and two exhibit-only registrations. Other company representatives may
register at a discount. For a prospectus and reservation
form, visit www.ncchc.org, e-mail [email protected], or call
Lauren Bauer at 773-880-1460, ext. 298.
Published by the National
Commission on Correctional
Health Care, this quarterly newspaper provides timely news, articles and commentary on subjects
of relevance to professionals in the
field of correctional health care.
Subscriptions: CORRECTCARE is free
of charge to all Academy of
Correctional Health Professionals
members, key personnel at accredited facilities and other recipients
at our discretion. To see if you
qualify for a subscription, submit a
request online at www.ncchc.org
or by e-mail to [email protected].
The paper also is posted at the
NCCHC Web site.
Change of Address: Send notification four weeks in advance, including both old and new addresses
and, if possible, the mailing label
from the most recent issue.
Editorial Submissions: We may, at
our discretion, publish submitted
articles. Manuscripts must be original, unpublished elsewhere and
submitted in electronic format.
For guidelines, contact the editor
at [email protected] or
773-880-1460. We also invite letters of support or criticism or correction of facts, which will be
printed as space allows.
www.ncchc.org
ds Q&A
Classified Advertising
Marketplace
n NCCHC
Standards for Health Services
on
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on
his
ds?
sf
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New Titles: Read and Learn
status. Those admitted to the infirTo purchase these books, visit the Web at
mary
on mental health watch are
www.ncchc.org or call 773-880-1460.
assigned
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“lifeliner,”
who
Shipping/handling
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added
comes
to
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to
sit
and
talk
to all orders.
with the suicidal inmate. Afterwards,
the
lifeliner
debriefs
with to
a mental
Bates’
Pocket
Guide
Physical
health
worker.
services
Examination
andThese
History
Taking,are
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This
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are a complement
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Bates but
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As long as the inmates in the
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umn format has exam techniques on the
to substitute for staff but only
left and abnormalities and interpretations
provide
on the right.
The supplemental
full-color designservices
features
for
the
suicidal
inmates,
you wouldThis
over 500 drawings and photographs.
be
in compliance
with
the relevant
edition
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P-C-06
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As you
drawings
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A
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CD-ROM has
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the
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cess
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LynnofBickley,
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MPH. Lippincott Williams & Wilkins
Corrective
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416Documentation
pages, $39.95
A
Q
Our facility’s accreditation
Clinicalsurvey
Guide:identified
Wound Care,
5th Ed.
a compliThis is the
only
all-in-one
portable
guide to
ance issue that was actually
wound care
and
prevention
strategies,
a systemwide problem. Thewith
more than
300 authorities
dressings, drugs
and the
other
central
office
revised
policy as required by the standard in
question. When we submit proof of
the corrective action, do we need to
send anything besides a copy of the
signed, revised policy?
products for every type of wound. Part I
gives detailed guidelines on wound care
and prevention, and related professional
and legal issues. Part II features profiles
Medication-Assisted
Treatment
and photos of over 300 wound
care prodIs III
there
resource
ucts. Part
has any
charts
of over about
200 addithe useand
of methadone
to
tional dressings
products. Appendices
drug addiction
jails?
include treat
assessment
tools andinmultiple
treatment
algorithms.
A manufacturer
Whenever
I raise
the subject,
guide
includes
addresses,
phone
numbers,
our
facility
physician
says
it’s just
Web sites and
manufacturer-sponsored
substituting
one
drug for another.
educational
programs.
by is
Cathy
Our
sheriff says
such a Edited
program
Hess,trouble
RN, BSN,
Lippincott
more
thanCWOCN.
it is useful.
Williams & Wilkins (2004). Spiral-bound
Addiction
heroin, morsoftcover,
544 pages,to
$39.95
Q
A
phine and some prescription
opioids
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Rosen and
Barkin’s
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communities.
Our
Medicinemany
Consult,
3rd Ed. This
best-sellcountry
has ahas
long
history
with the
ing reference
been
thoroughly
updated. The
foremostthey
authorities
provide
pracuse
of opioids;
were even
used
tical information
over
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probduring
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War
to600
reduce
pain.
lems in abecause
fast-access
outline forPerhaps
of two-page
this long-term
mat that’s perfect
for on-the-spot
experience
with opioids,
thereconsultaare
tion. Coverage
of each about
disorder
includes
many
misconceptions
the
clinical presentation,
prehospital, diagnotreatment
of opioid addiction.
sis,
treatment,
disposition
more. Icons
There are two schools and
of thought
enable
practitioners
to
quickly
spot the
about treatment. The first is that
information
they
need.
This
edition
prothis addiction originates because the
vides current information on emerging
person is weak-willed and lacks the
infections, new protocols and new treatindividual strength to resist drugs.
ments. By Jeffrey Schaider, MD, Stephen
Other environmental or psychologiHayden, MD, Richard Wolfe, MD, Roger
cal
factors may also contribute to
Barkin, MD, MPH, & Peter Rosen, MD.
addiction. In this model, abstinence
is the only way to treat. The second
approach is that opioid addiction is
Employment
Lippincott Williams & Wilkins (2006).
Hardcover, 1,336 pages, $84.95
Substance Abuse Treatment with
Judith A. Stanley
R. Scott Chavez
Correctional Clients. This book provides
key research findings and policy implications for treating addicted clients. Topics
an
incurable
disease
that requires
include
theoretical
explanations
for sublong-term
maintenance
medicastance abuse;
best practicewith
treatment
protion—
as for
hypertension or treatdiagrams; just
the use
of coerced/mandated
betes.
as medication-assisted
ment; Known
correctional
settings; communitytreatment
(MAT),programs;
this approach
is
based treatment
and special
treatment populations,
including
juveniles.
advocated
by the American
Society
of
Edited by Barbara
Sims.
Haworth (2005).
Addiction
Medicine,
a supporting
Hardcover, 258+
pages, $39.95
organization
of NCCHC.
Working
with SAMHSA and CSAT, NCCHC has
Health Issues
Among Incarcerated
developed
an educational
CD-ROM
Women.
The
20
essays
this comprehenon MAT and the use ofinmethadone
in
sive book address
the challenges
health
correctional
facilities
and will of
send
it
care
delivery
that meets
unique physito
jails
and prisons
thisthe
summer.
You
cal and
needs
female inmates.
may
findmental
it helpful
in of
answering
the
Edited by Ronald Braithwaite, Kimberly
objections that your medical director
Jacob Arriola & Cassandra Newkirk.
and sheriff have raised.
Rutgers University Press (2006). Softcover,
376+ pages, $29.95
Judith A. Stanley, MS, CCHP-A, is
NCCHC’s
Using the director
MMPI-2 of
inaccreditation
Criminal Justice
and
oversees
the
development
and Correctional Settings. This isand
the first
revision
standards.
R. Scott Chavez,
work thatofinstructs
correctional
psycholoPhD,
MPA,
is NCCHC’s
gists in
the CCHP-A,
unique applications
and vice
interpretationsand
of the
mosttowidely
used and
president
liaison
the policy
thoroughly
researched
personality assessand
standards
committee.
ment
in correctional
settings.
Sendinstrument
your question
to Standards
By Edwin
Megargee.
Q&A,
c/o NCCHC,
1145University
W. Diverseyof
MinnesotaChicago,
Press (2006).
Softcover,
Parkway,
IL 60614;
e-mail480
pages, $50
[email protected];
fax 773-880-2424.
NCCHC’s accreditation is
Xbudi!Zpvs!
facility-specific. When corrective action is forwarded,
Dbsffs!Hspx
we need to be as sure as we
A
canDpssfdujpobm!Nfejdbm!Tfswjdft!jt!
that the action was implemented
at the
facility. The accreditation
uif!jefbm!eftujobujpo!up!bewbodf!
committee also wants to know
zpvs!dbsffs!boe!uisjwf!jo!b!vojrvf!
whether the corrective action
fowjsponfou!qspwjejoh!mfbefstijq!
described
has solved the concerns.
jo!dpssfdujpobm!ifbmuidbsf/!
Suppose
the compliance issue has
to do with missing information on
theEjsfdups!pg!Ovstjoh!boe!
co-pay system for inmate-initiated
health
services. Written, systemwide
Ifbmui!Tfswjdf!Benjojtusbups!
information
on co-pay policies that is
Nbobhfnfou!pqqpsuvojujft!
given to incoming inmates does not
bwbjmbcmf/!Dbmm!!Dpvsuofz!Qfoojoh!
state that no one will be denied care
bu!911/436/591:-!fyu!:617/!
because
of inability to pay. After the
survey at Facility X, the central office
issues
a directive that thedpn/
information
Wjtju!vt!bu!xxx/dnttum/
sheet is to be revised and reprinted.
Sending NCCHC a copy of that directive is part of the answer. However,
we want to know what is happening
now at Facility X. Did you print a
temporary sheet with the needed
information? (Please send a copy.)
When were staff in-serviced about
the change? (Send date and sign-in
for the in-service.) As of when are the
new sheets being used? (What confirmation can you send?) What about
the inmates already at the facility;
what is being done to inform them of
the change? (New signs outside the
clinic? Please send a picture.)
In short, we need documentation
that describes the actions taken at
the facility surveyed, but we also need
proof that those actions actually
occurred and had the intended effect.
Ad
CMS
1/8 page
b/w
new PDF
www.ncchc.org
Meetings
NCCHC’s National Conference. The premier meeting in correctional health care
takes place Oct. 13-17 in Nashville, TN.
For a schedule of events and online registration, see www.ncchc.org; to obtain a
brochure, call 773-880-1460. Also see the
back page for more information.
Youth Psychiatry. The American Academy
of Child & Adolescent Psychiatry is holding
its 54th annual meeting Oct. 23-28 at the
Sheraton Hotel in Boston. Find details at
www.aacap.org, or call 202-966-7300.
Pediatrics Conference. The American
Academy
of
Pediatrics’ National
Conference and Exhibition will take place
Oct. 27-30 in San Francisco. See ww.
aap.org for details, or call 847-434-4000.
Regional HIV Meeting. The Southwest
Regional HIV/AIDS Conference is being
held Nov. 1-2 in Scottsdale, AZ. Hosted by
the nonprofit Body Positive and the
Arizona Department of Health Services,
the meeting offers CEUs. Learn more at
www.bodypositive.org.
Public Health. Washington, DC, will be
the site of the American Public Health
Association’s Annual Meeting and
Exposition, Nov. 3-7. Find info at
www.apha.org, or call 202-777-2742.
Sheriffs’ Meeting. The National Sheriffs’
Association will hold its annual winter conference Jan. 16-20 at the J.W. Marriott in
New Orleans, LA. Information is posted at
www.sheriffs.org, or call 703-836-7827.
Accreditation
Opioid Treatment
Programs in Corrections
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Ad
King County Public Health
Work for the Public Health Department of Seattle & King County
providing mental health care in the Seattle metropolitan area!
Seattle is a beautiful, progressive city with a quality of life most
consider among the best in the country. Public Health seeks a
psychiatrist to join the Psych Services team treating incarcerated
persons in the King County Correctional Facility; most of the work
is in the downtown facility but may also include work in the Kent
facility. We have a strong community mental health focus and work
closely with our medical colleagues in the jail.
1/4 page
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pickup 21-2, p.21
Senior Staff Physicians provide direct patient care to jail inmates.
Other responsibilities include participation in quality improvement /
quality assurance programs to support Jail Health Services care
goals; medical oversight, consultation, and management of
specialized health care programs for Jail Health Services.
Both Jobs Salary: $119,579.20 - $151,569.60 annually
Location: Seattle & Kent, Washington
Benefits: comprehensive package of benefits to Career Service.
Apply On-line: http://www.metrokc.gov/health/about/jobs.htm
For further inquiries, please contact
Martha Driver([email protected])
SPRING 2007 • CorrectCare 21
Is your prison, jail or juvenile facility
considering an on-site opioid treatment program? By law, OTPs based
in correctional facilities must be certified by the U.S. Department of Health
and Human Services’ Substance
Abuse and Mental Health Services
Administration. But to become certified, an OTP first must be accredited
by a federally approved body.
The National Commission on Correctional Health Care is one of only six
agencies authorized to accredit opioid
treatment programs, and the only one
to focus on correctional facilities.
NCCHC’s Standards for OTPs comply
with federal regulations while recognizing the special nature of these
facilities.
Visit the Web to obtain an informational brochure or to order the
Standards. Or contact NCCHC for
more information.
www.ncchc.org
[email protected]
(773) 880-1460
SUMMER 2007 • CorrectCare 23
National Conference on Correctional Health Care
Nashville • October 13-17
The Stage Is Set! You can make no better time investment—professionally and personally—than by attending this conference. Sharing and learning will
take on a fresh new look at this event. A robust, forward-thinking curriculum featuring the thought leaders in this field will stimulate new ideas about how best
to deliver care and foster professionalism. We are confident that this program will be time well spent—and perhaps the most valuable educational program of the
year. You will come away renewed and committed to change, armed with a wealth of new strategies and connections you’ll find nowhere else.
Sessions for Every Level of Experience
A Special Guest With Star Power
Whether you’re a seasoned leader or a newcomer
to corrections, you will find valuable guidance at
the conference. With sessions geared toward basic,
intermediate and advanced levels of experience and
knowledge, the program will deliver an unparalleled array of opportunities to learn and grow.
Below are just a few of the outstanding sessions
designed for advanced learners.
• Advanced Wound Care in the Correctional
Environment
• Best Practices for Becoming an Inspired Leader
in Corrections
• Bioethical Discussion Behind Bars
• Correctional Health Care Staffing: It’s Not an
Art, It’s a Science
• Creation of a Metabolic Monitoring Program for
Atypical Antipsychotics
• Fiscal Self-Defense: Defending Your Budget to
Commissioners, Legislators and the Public
• Overcoming Imposed Budget Cuts While
Maintaining Vital Services
• We Thought We Had a Disaster Plan: What
Hurricane Katrina Taught Us
• Why Did the Inmate Sue Us? An Advanced Look
at Litigation Trends and Prevention
Ready for a little a glamour with your education?
Sheryl Lee Ralph—of Dreamgirls, Moesha and
Sister Act II fame—will open
the exhibit hall on Sunday
evening and deliver the keynote
address on Monday morning.
Sheryl Lee is more than just a
gorgeous, multitalented celebrity. She also is an activist and
motivation speaker who in 1990
established the Diva Foundation
to create awareness of and combat against HIV/AIDS. That will
be the focus of her talk on Monday. On Sunday,
however, she promises to thrill the audience with a
song. You don’t want to miss it!
Leadership Series
This series was a hit last year so we’re bringing it
back. Designed for managers, both new and experienced, these sessions will help you hone your skills
to become a more effective leader. Look for the
keyword “Leadership” in the Schedule at a Glance.
• Interactive and high-level educational experiences
• Expert faculty with vast experience in and knowledge of correctional health care
• Diverse topics for a well-rounded view of the
nuances of leadership and management
• Practical information to help you become more
effective and efficient
New! Longer Sessions
To provide more in-depth education on selected
subjects, two of the concurrent sessions will run
for two hours instead of the usual one. Check the
schedule for presentations during these sessions:
• Session 2: Monday, 1:15 pm to 3:15 pm
• Session 11: Wednesday, 1:15 pm to 3:15 pm
2. Stroll down Second Avenue and Printers Alley,
the downtown HQ of Nashville’s after-hours beat.
Or try The Gulch or Jefferson Street areas for more
action.
3. Some of the Civil War’s fiercest battles were
fought on Nashville soil. See what both Union and
Confederate armies saw from the spectacular vantage point of Fort Negley, built by free African
Americans.
4. Head to Fisk University to explore one of
MSN.com’s Top 10 American black history sites.
You’ll also find two of the city’s visual arts treasures: the Aaron Douglas Gallery and the Carl Van
Vechten Gallery.
6. Learn about the city’s pivotal role in civil rights
history from the Civil Rights Collection at the
Nashville Public Library.
Exceptional Exhibition
Besides the star power of Sheryl Lee, the exhibit
hall is the nexus of so much good stuff. That
includes the exhibitors themselves, of course, our
vital partners in the provision of high quality
health care (see page 16 for a list of organizations
that will be represented at the meeting).
Let’s not forget the exhibit hall raffles, during
which NCCHC’s very own in-house divas hand out
tantalizing prizes, many of them donated by generous exhibitors, to dozens of attendees. (Don’t lose
that raffle ticket! Please write legibly!)
7. Visit the campus of Meharry Medical College,
the nation’s first medical education program established for African Americans.
8. Soak in the proud sports legacy of Tennessee
State University: Wilma Rudolph and the Tiger
Belles, most notably basketball and football.
9. The County Music Hall of Fame and Museum features the exhibition “I Can’t Stop Loving You: Ray
Charles and Country Music,” tracing the lifelong
love affair the “genius of soul” had with country
music that redefined American popular music.
10. The Frist Center for the Visual Arts features
“The Quest for Immortality: Treasures of Ancient
Egypt,” with the largest group of antiquities ever on
loan from Egypt for exhibition in North America.
Nashville Area Welcome Committee
It can be hard to decide what to do with your free
time when you’re in an unfamiliar city. That’s why
Academy members from Tennessee have created an
insider’s guide to Nashville. From favorite restaurants to site seeing to travel advice, their tips will
help you make the most of your conference experience. Check out their recommendations at the
Academy booth in the exhibit hall.
New! Speaker Q&A
Did you ever wish you had a chance to pick the
speaker’s brain after the session ended? Now you
can. Selected speakers will stay for a roundtable
Q&A. These discussions are scheduled to extend
through the session period that follows their talk.
1. In Music City can you hear jazz, blues, R&B,
country and rock any night of every week. Check
out the club scene all around town. It never sleeps.
5. A bounty of Southern and Soul cooking awaits
you at a number of homestyle restaurants. Pass the
biscuits and save room for pie.
Advancing Your Education
Nearly 40% of our conference attendees have been
working in thise field for 10 or more years! With
you in mind, we’ve developed a significant number
of advanced level sessions. The Schedule at a
Glance and Abstracts indicate the skill level for
each session using the labels Basic (B),
Intermediate (I) and Advanced (A).
10 Things You Can Do Only in Nashville
There’s the networking lunch on Monday, of
course. And this year, viewing the educational
posters will be easier than ever: They will be display
in the exhibit hall throughout the meeting. The
presenters will be on-hand to discuss their work
during the opening reception on Sunday evening.
The posters address a broad range of topics: program innovations, research findings, treatment
recommendations and more.
Thanks to our conference cohosts
NCCHC and the Academy thank our cohosts
for their support of the National Conference
on Correctional Health Care.
• Tennessee Department of Correction
• Tennessee Department of Children’s Services
• Tennessee Sheriffs’ Association
• Davidson County Sheriff’s Office
Sponsored by the National Commission on Correctional Health Care and the Academy of Correctional Health Professionals
Find complete conference information and online registration at www.ncchc.org.
To obtain a preliminary program with registration form, visit our Web site, e-mail [email protected], or call 773-880-1460.