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CORRECT C CA AR RE 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 WE PROVIDE COMPREHENSIVE DENTAL CARE IN EVERY CORRECTIONAL SETTING COAST TO COAST * ON SITE DENTAL CARE WHERE NO EQUIPMENT EXISTS * OWNED AND OPERATED BY NCCHC CERTIFIED PERSONNEL * COST CONTAINMENT - PROVIDE OUR OWN SUPPLIES & LAB * WE PROVIDE ALL EQUIPMENT, SUPPLIES AND STAFFING NO MORE DENTAL TRANSPORTS FOR MORE INFORMATION CALL TEL 610/294-7994 FAX 610/294-7995 EMAIL: [email protected] WWW.DENTRUSTDENTAL.COM 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 shipping and handling. Price after November 1, 2007: $237.50. (609) 683-4450 Fax (609) 683-7291 www.civicresearchinstitute.com/mdi.html 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- Beyond a reasonable doubt... and TampAlerT ® The most trusted names in tamper-evident unit dose packaging Since 1971, correctional facilities have relied on the proven Medi-Dose systems for the quickest, safest and most economical way to package solid oral medication. They’re tamper-evident, ultraviolet inhibitant and minimize errors and pilferage. Plus Medi-Dose contains no metal or glass! With TampAlerT, a twist of the wrist is all you need to dispense liquids in no-leak, tamper-evident unit dose. TampAlerT vials are available from 15 ml to 120 ml, in natural or ultraviolet inhibitant polyethylene, with either regular or child-resistant screw caps. Each cap contains a tamper-evident seal. And TampAlerT contains no metal or glass! 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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 MedGuard is a brand new concept that offers you the opportunity to take ownership of your health care career. When you invest in a MedGuard franchise, we help you secure a contract to provide health care in a county jail and protect you against liability issues. It’s the ideal way to enjoy the professional and personal flexibility that’s rare in nursing and other health care jobs. Visit our Web site or call 800-827-6627 to get your chance at entrepreneurial freedom in correctional health care. M E D G U A R D H E A LT H . C O M 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]. Is your inmate health care system on life support? 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SYSCON JUSTICE SYSTEMS, the World Leader in Offender Management Systems, now adds Electronic Health Records to its suite of justice applications. www.syscon.net 1.888.797.2662 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 .ZUI -ENTALHEALTHLITIGATIONISUNAVOIDABLE )TSEEMSTHATWAYWITHMORETHANSTATESNOWFACINGLEGALTROUBLES"UT -(-KEEPSCLIENTSOUTOFCOURTBYWAYOFIMPROVEDCLINICALOUTCOMES SPECIALIZEDINMATEPROGRAMSANDVIGILANTQUALITYASSURANCE4HENATIONS LEADINGPROVIDEROFCORRECTIONALMENTALHEALTHMANAGEMENTANDSTAFlNG-(- ISTHEONLYCOMPANYTOHAVESUCCESSFULLYRESOLVEDMENTALHEALTHLITIGATION "ETTERYET-(-ALSOKEEPSYOUOUTOFTHERED%FlCIENTSTAFlNGANDEXCEPTIONAL MEDICATIONMANAGEMENTCANSAVEHUNDREDSOFTHOUSANDSOFDOLLARSYEARLY )TSAFACT)FYOUWANTTOSTAYOUTOFTHECOURTROOMITSTIMETOSEETHESPECIALIST #ONTACT-(-TODAY - (-3ERVICES)NC 4HE#ORRECTIONAL-ENTAL(EALTH3OLUTION WWWMHMSERVICESCOM • 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 National Conference Exhibitors: Our Vital Partners We seldom stop to think about it, but where would we be without the countless suppliers of goods and services that make our work possible? Come meet with these invaluable partners in the exhibit hall during the National Conference on Correctional Health Care. Knowledgeable representatives from more than 100 companies will be on site to show you the products and services available to assist you in your work. Learn more about the meeting on the back page. Abbott Laboratories 509 Academy of Correctional Health Professionals 220-222 ACC Consultants 528 Albany Medical College Division of HIV Medicine 314 Alkermes 821-823 Allscripts 727 American Association of Public Health Physicians 208 American Correctional Health Services Association 328 American Diabetes Association 210 39289_AT_222_11174_2Pg-PI 7/12/07 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 AstraZeneca 504 ATC Health Care 729 Ballymore Medical Management 411 Biomedical Systems 909 Boehringer Ingelheim 203-205 Bristol-Myers Squibb 602 Business Computer Applications 827-829 California Department of Corrections and Rehabilitation 913 Office of Workforce Planning 917 Calmoseptine 408 3:35 PM Care Scoper Data Futures CareData Solutions Casa Playa CCHP Program CFG Health Systems Clinical Solutions CompuMed Contract Pharmacy Services CorEMR Correct Rx Pharmacy Services CorrectCare — Integrated Health Correctional Eye Care Network Services Page 1 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. 322 627 302 215 321 822 427 717 910 311 508 815 Correctional Healthcare Management 527 Correctional Medical Associates 316 Correctional Medical Services 710 Dentrust Dental 904 Derby Industries 403 Diamond Pharmacy Services 202-204 DIANAssociates 925 DSS 410 Eli Lilly and Co. 405 Elsevier/WB Saunders Mosby 304 First Medical Management 914 Garcia Laboratory 629 GEO Care 402 Gilead Sciences 605 GlaxoSmithKline 703 Global Diagnostic Services 628 Harloff 623 Health Professionals Ltd. 526 Henry Schein 720 Hibiclens 404 Humane Restraint Co. 817 Hythiam 327 IDCR 209 INScope Division of Ethicon 505 Janssen 708 Kalos 916 Martin Medical Services 816 Maxim Staffing Solutions 908 Maxor Correctional Pharmacy Services 615 McKesson Medical-Surgical 808 Medcom Correctional Services 223 MedGuard Health Services 903 Medical Air Solutions 308 Medical Doctor Associates 428 Medical Staffing Network 715 Medique Products 809 Merck & Co. 310 MHM Correctional Services 702 Mobile Dentists/Smile Programs 919 Moore Medical 420 MTJ American 922 Nanogen Point-of-Care 503 NaphCare 305-303 National HIV/AIDS Clinicians’ Consultation Center 728 National Institutes of Health HIV/AIDS Research 911 National Library of Medicine 626 NCCHC 214-216 NextGen Healthcare 603 Nurse Rosie Products/Life Systems 820 Parkland Health & Hospital System 426 Pearson 716 Pfizer 414 Pride Dental Laboratory 726 Prime Health Services 309 Prison Health Services 617 Quest Diagnostics 805 Registry of Physicians Specialists 529 Reporters Transcription Center 721 Roche Laboratories 621 Sage Publications 803 Scrubs in Motion/Advance Nursing 905 Society of Correctional Physicians 211 Syscon Justice Systems 811 Systemedx 902 Tibotec Therapeutics 709 Tri-Tech Health 915 UDL Laboratories 722 U.S. Medical Group 611 UTMB Correctional Managed Care 221 Valeant Pharmaceuticals 323 Valley Healthcare Systems 502 Vertex Healthcare Consulting 326 Virco Lab 714 Washington Dept. of Corrections 723 Western Litigation 907 Westwood Pharmacy 920 List current as of Sept. 10. 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. Ad PHS With more than 28 years of experience providing quality correctional healthcare, Prison Health Services asks you to take a closer look. 1/4 page b/w S H A W N , R .N . new PDF Prison Health Services, Inc. 105 Westpark Drive, Ste. 200 Brentwood, TN 37027 800-729-0069 www.prisonhealth.com 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 conference program • 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 educational sessions on hot topics demonstrates support of the correctional field and provides great exposure. 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 n on his ds? sf ny o tes ns if ons ial th, , est wsiwill ant asis. is ould cal a nt or nd e of her ons. at n an- y ot ss sa he ed aurute rt sui- ita- suiates l linial 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 a trainedcharges lifeliner, who Shipping/handling will be added comes to the infirmary 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 5thnot Ed. in lieu of formalguide mental health This pocket-sized presents thetreatclassic ment are a complement to it. Bates but approach to physical examination and history taking in a quick-reference As long as the inmates in the outline format. The easy-to-follow two-collifeline program are not used 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 gives greater emphasis to patient standards, P-C-06 Inmate Workers and communication and interview techniques, P-G-05 Suicideon Prevention Program a new chapter older adults, and new (2003 Prison Standards). As you drawings and photos of abnormalities. A implied, training supervision of CD-ROM has a PDAand download with outlines the lifeliners is essential to the suc- By of exam procedures and techniques. cess such aMD, program. LynnofBickley, & Peter Szilagyi, MD, MPH. Lippincott Williams & Wilkins Corrective Action (2005). Softcover, 416Documentation pages, $39.95 A Q Our facilitys 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 its 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 is a 5-Minute major problem in Rosen and Barkin’s Emergency 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 clinical probduring the Civil on 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 NCCHCs 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 NCCHCs 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. NCCHCs 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 3V\FKLDWULVW 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 b/w 6HQLRU6WDII3K\VLFLDQ 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.