Fall - National Commission on Correctional Health Care
Transcription
Fall - National Commission on Correctional Health Care
C rrectCare Fall 2011 | Volume 25 | Issue 4 ™ The magazine of the National Commission on Correctional Health Care KOP Glucometers in Prison? It’s Working Great in California The Right Way to Deal With Outside Physicians Small Jail Makes Big Strides in Care 2011 Award Winners Take the Spotlight National Commission on Correctional Health Care 1145 W. Diversey Parkway, Chicago, IL 60614 The National Commission on Correctional Health Care presents Updates in Correctional Health Care Preventing Recidivism: Where Do You Fit In? May 19-22, 2012 z San Antonio Join your colleagues in a vibrant forum where you will advance your knowledge and skills while earning up to 25 hours of continuing education credit, networking with colleagues and enjoying the beautiful and historic Alamo City. This meeting will feature presentations on a broad array of correctional health care topics as well as a special series focusing on the role of correctional health services in reentry programming and prevention of recidivism. For more information, visit www.ncchc.org or email conference@ncchc.org. CorrectCare™ 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 the leading national organizations representing the fields of health, law and corrections. contents 12 Features Departments 4 New Position Statement 2 NCCHC News 3 Guest Editorial: Why Multi- Addresses Chronic Pain 8 Award Winners Take the Spotlight at National Conference 12 KOP Glucometers in Prison? It’s Working Great in California 16 The Right Way to Deal With Outside Physicians 18 Correctional Nursing Practice (Part 8): Regulations, Standards and Policies 24 Facility Profile: Small Jail Makes Big Strides in Care cultural Awareness Is Important 25 26 News Watch Journal Preview: Triage Critical for Toothache Complaints 27 28 Clinical Briefs 30 CCHP Page: 20th Anniversary a Smash Success! 32 36 Field Notes Juvenile Voice: Psychological First Aid for Youth Standards Q&A Our Independence Matters The National Commission on Correctional Health Care has no membership or dues. NCCHC does not require any affiliation to be considered for accreditation, certification or employment as a consultant or surveyor, or to serve on committees or the board of directors. NCCHC staff and spouses are not allowed to accept gifts or consulting fees from those we accredit or certify. NCCHC is impartial, unbiased and expert. And dedicated only to recognizing and fostering improvements to the field of correctional health care. C rrectCare Fall 2011 | Volume 25 | Issue 4 ™ BOARD OF DIRECTORS Carl C. Bell, MD, CCHP (Chair) National Medical Association Judith Robbins, LCSW, CCHP-A (Chair-Elect) National Association of Social Workers Peter C. Ober, PA-C, CCHP (Immediate Past Chair) American Academy of Physician Assistants Patricia N. Reams, MD, CCHP (Secretary) American Academy of Pediatrics Thomas J. Fagan, PhD (Treasurer) American Psychological Association Edward A. Harrison, CCHP (President) National Commission on Correctional Health Care Patricia Blair, JD, CCHP American Bar Association Eileen Couture, DO, CCHP American College of Emergency Physicians Kevin Fiscella, MD American Society of Addiction Medicine Robert J. Gogats, MA National Association of County and City Health Officials Joseph Goldenson, MD American Public Health Association Robert L. Hilton, RPh, CCHP American Pharmacists Association Renee Kanan, MD American College of Physicians JoRene Kerns, BSN, CCHP American Correctional Health Services Association Ilse R. Levin, DO American Medical Association Douglas A. Mack, MD, CCHP American Association of Public Health Physicians Nicholas S. Makrides, DMD American Dental Association Pauline Marcussen, RHIA, CCHP American Health Information Management Association Edwin I. Megargee, PhD, CCHP International Association for Correctional and Forensic Psychology Charles A. Meyer, Jr., MD American Academy of Psychiatry and the Law Eugene A. Migliaccio, DrPH American College of Healthcare Executives Ronald C. Moomaw, DO American College of Neuropsychiatrists Robert E. Morris, MD, CCHP Society for Adolescent Health and Medicine Joseph E. Paris, MD, CCHP-A Society of Correctional Physicians Joseph V. Penn, MD, CCHP American Academy of Child and Adolescent Psychiatry Peter E. Perroncello, MS, CCHP American Jail Association George J. Pramstaller, DO, CCHP American Osteopathic Association Sheriff B. J. Roberts National Sheriffs’ Association David W. Roush, PhD National Partnership for Juvenile Services Jayne Russell, MEd, CCHP-A Academy of Correctional Health Professionals Ryung Suh, MD American College of Preventive Medicine Ana Viamonte Ros, MD Association of State and Territorial Health Officials Patricia Voermans, MSN, CCHP-RN American Nurses Association Barbara A. Wakeen, RD, CCHP American Dietetic Association Henry C. Weinstein, MD, CCHP American Psychiatric Association Nancy B. White, LPC American Counseling Association Ronald Wiborg, MBA, CCHP National Association of Counties Copyright 2011 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 editor Jaime Shimkus NCCHC, 1145 W. Diversey Pkwy., Chicago, IL 60614 Phone: 773-880-1460; Fax: 773-880-2424 editor@ncchc.org; www.ncchc.org NCCHCnews Get in Tune With CHORDS Although measurement underlies quality improvement efforts within facilities, it does not enable examination of performance on a large scale, in comparison with peers. For that, benchmarking is essential. Such benchmarking is commonplace in community-based hospitals and health networks, which rely on these data not only for quality improvement but also to satisfy payor requirements. To date, however, the correctional health care field has done very little benchmarking of health care performance, although it could greatly enhance quality and effectiveness of care. This is due, in part, to a lack of robust, uniform performance measures tailored to the unique correctional setting, as well as the absence of a way for facilities to share data. These major obstacles will soon be a thing of the past. Building on a chronic disease data reporting program it initiated several years ago, NCCHC is now working with leaders of a variety of correctional systems throughout the country to establish a national performance measurement system called CHORDS (Correctional Health Outcome and Resource Data Set). Broadly speaking, CHORDS will consist of the following elements: • Standardized performance measures, with an emphasis on effectiveness of care, availability of and access to care, use of services, cost of care and others • A data repository to establish regional and national benchmarks for participants • Data reporting capabilities to help correctional systems track, trend and compare data over time This important effort has the potential to impel quality improvement in correctional institutions across the nation and, ultimately, benefit the public health. Stay tuned for updates as the project progresses. Board Member Update Carl C. Bell, MD, CCHP, became board chairman at the annual board meeting on Oct. 16 in Baltimore. Bell knows well the work of the National Commission: He is a founding member of the board of directors who served as chair in 1991. An expert in correctional psychiatry, he will focus on prevention as well as violence reduction in incarcerated populations during his term (see the next issue for a profile). He represents the National Medical Association on the board. At that same board meeting, Judith Robbins, LCSW, CCHP-A, was selected as chair-elect. She has represented the National Association of Social Workers since it became a supporting organization in 2005. Robbins directs a statewide mental health program for pretrial youth through a contract with Connecticut’s judicial branch and has been heavily involved with NCCHC’s juvenile health committee. Welcome to Two New Board Members • Joseph Goldenson, MD, representing the American Public Health Association: Employed by the San Francisco Depart ment of Public Health, Goldenson is the medical director of the San Francisco jail, a position he has held for 20 years. • Ilse R. Levin, DO, representing the American Medical Association: Employed by Unity Healthcare, Levin is a staff attending physician at the Washington DC Department of Corrections and the Reentry Clinic, providing care to inmates and halfway house residents. Calendarof events February 18 CCHP exam, regional sites March 16 Accreditation committee meeting May 19-22 Updates in Correctional Health Care conference, San Antonio May 20 CCHP exam, San Antonio June 22 Accreditation committee meeting July 20-21 Boot Camp Series: Medical Directors and Health Administrators July 22-23 Correctional Mental Health Seminar For the complete list of CCHP exams, including regional exam sites, see ncchc.org/cchp. In Other News ... New Position Statement and Guidelines for Disease Management The policy and standards committee complete work on, and the board adopted, three documents in October. All are available at ncchc.org, Resources section. • Position Statement: Management of Chronic Pain (see page 4 for 10 key points) • Guideline for Disease Management: Adolescent Obesity • Guideline for Disease Management: Adolescent Sickle Cell Disease AMA Resolution on Correctional Health Care The American Medical Association reaffirmed its support of correctional health care this year when it adopted a resolution titled Maintaining AMA’s Commitments to Public Health and Correctional Health Care. The resolution was submitted by the American Association of Public Health Physicians. Both groups are supporting organizations of NCCHC and are represented on its board of directors. 2 Fall 2011 • CorrectCare www.ncchc.org Guesteditorial Why Multicultural Awareness Is Important by Mark Fleming, PhD O ver the years, the field of mental health counseling has become increasingly aware of the critical importance of not only recognizing diversity but also implementing multiculturally aware practices when working with clients. In our attempts to be multiculturally aware, it is imperative to recognize that issues around diversity include not only race but also gender, disability status, residency status, sexual identity, geographical location, socioeconomic status, political affiliation and religious identity, to name a few. As practitioners, it is incumbent upon us to recognize the importance of multicultural awareness, be cognizant of the potential pitfalls from a lack of awareness and use appropriate practices to heighten awareness in ourselves, others and the systems in which we work. Multicultural awareness in corrections is important for a variety of reasons. First, there has been an emergence for a greater attendance to an ever-increasing diverse population. In recent years, it has become more evident that the traditional theoretical orientations and assessments are inappropriate for clients from certain cultural backgrounds. As a result, the American Psychological Association published guidelines on working with ethnically and linguistically diverse populations. Second, an increased understanding of diversity increases a counselor’s repertoire of skills and perspectives by adding a fourth dimension to the three traditional helping orientations (psychodynamic, humanistic-existential and cognitive). This fourth dimension helps the counselor to understand the client in the context of the client’s cultural lens, thereby minimizing therapist projections and potential negative feelings of countertransference. Third, awareness challenges the assumption that one approach to counseling is transferable to all clients. As clinicians, we must engage in the daily practice of seeing each of our clients as unique individuals who must be accepted and respected. Awareness is critical in that unintentional isms are as serious and harmful as intentional isms. For example, if a therapist asks a male inmate if he has a wife, the therapist has engaged in heterosexism. A more appropriate question would be if the inmate has a significant other or partner. When a practitioner lacks awareness of multicultural issues, there is a greater potential for harm to the client and to the therapeutic relationship. This harm may manifest in many ways, including the therapist forcing his or her worldview on the client, the therapist conceptualizing a patient through a culturally biased lens and the client feeling as if the therapist is culturally insensitive, with the result that the client does not fully engage in the process of therapy. Without an active attempt to increase one’s awareness of diversity issues, biases can easily interrupt or undermine the therapeutic process. Without understanding the values and belief systems of our clients, we are destined to engage in treatment from our own worldview as opposed to the client’s worldview. Biases can impair a counselor’s ability to diagnose and plan appropriate interventions. Biases can also interfere with a counselor’s conceptualization of causes of and solutions to the client’s problems, or with the ability to accurately discern the difference between internal and external causes of the client’s problem. Heightening Awareness There are no quick ways to heighten awareness in ourselves, others or the systems in which we work. The most lasting ways are processes that must be initiated over time and gradually worked into the fabric of the individual or the system. There are several ways in which practitioners can begin the process of heightening awareness both at the individual and systemic levels. Individually, practitioners must first and foremost engage in a journey of self-discovery regarding their own biases and assumptions and how these may play out in a therapeutic environment. Secondly, practitioners must be sure not to impose personal beliefs on the client or the system. Lastly, it is incumbent upon the practitioner to strive for an increased awareness into multiculturalism through trainings, seminars and classes. In the correctional environment, one of the primary ways to heighten awareness is through a diversity mission statement. The system also must work diligently to recruit, retain and promote individuals from diverse backgrounds. The correctional system and all of its subsystems must foster a welcoming and inclusive environment. This can be achieved by building a tradition of inclusion even amid a history of exclusive practices. Having translators available, establishing policies that directly address employees who use discriminatory language and behaviors, and offering flexible benefits and service plans that meet the needs of all employees are other ways to heighten awareness. As we move rapidly into the 21st century, an increased awareness of the importance of multiculturalism and diversity in correctional settings will be an ever-present issue. As individuals and systems strive to meet the needs of all cultural identities of inmates and employees, practices at both the personal and systemic levels must be fully integrated. Though the task may seem daunting, the journey can be achieved one step at a time. Mark Fleming, PhD, is director of behavioral health services, Corizon, St. Louis, MO. He presented on this topic at three NCCHC educational conferences in 2011. 3 www.ncchc.org Fall 2011 • CorrectCare New Position Statement Addresses Chronic Pain It is important to evaluate and manage inmates with chronic pain. NCCHC’s new position statement on the topic emphasizes that corrections clinicians should be knowledgeable and skilled in the management of this challenging problem and seek training as necessary. Below are the 10 key points of the statement. Find the complete document, including introductory information, at ncchc.org. Position Statement 1. Chronic pain is a distinct clinical entity, requiring an understanding of pain mechanisms, evaluation, and treatment options. 2. Because a fundamental knowledge of the correctional health care environment and their patients is needed, properly trained primary care clinicians are uniquely qualified to treat chronic pain in correctional settings. 3. Medical directors and other responsible health authorities should facilitate and encourage appropriate training covering the requisite skills to make reliable diagnoses, establish appropriate treatment plans, and monitor progress for patients with chronic noncancer pain. 4. Nationally recognized guidelines regarding the care and treatment of chronic pain should be referenced and adapted to the correctional environment. 5. Chronic pain should be addressed like other chronic medical conditions, in a systematic, objective, structured manner beginning with diagnosis and treatment planning and proceeding with structured and regular monitoring of progress. 6. Clinicians should establish measurable treatment goals for chronic pain and measure progress against them. Treatment goals should be discussed with the patient but determined by the clinician. They must be functional in nature, measured against the patient’s established baseline, and monitored. The elimination of chronic pain is usually not a realistic goal. Patient expectations must be addressed early. Patient self-report may not be completely reliable but should be included in the assessment. 7. Most chronic pain can be managed through primary care clinicians. However, an interdisciplinary team approach is often beneficial, and specialty care, including pain management, should be available for patients whose function and chronic pain are not improved with treatment and for patients requiring end-of-life care. 8. Accepted and evidence-based therapeutic options should be available when medically necessary. A multifaceted and biopsychosocial approach is optimal when possible. Policies banning opioids should be eschewed. 9. Medication use should be judicious. Benefits and risks for the patient (including abuse) and the facility (potential for diversion) must be considered, recognizing that problems with substance abuse, chemical dependency, and management of prescription medications are common in correctional populations. 10. Continuity of care planning is important, including consideration of resources and reentry into the community. Care coordination should be ensured to avoid interruption in pain treatment. 4 Fall 2011 • CorrectCare www.ncchc.org Award Winners Take the Spotlight at NCCHC’s 2011 National Conference T he National Commission’s annual awards pay tribute to leaders and innovators that have enriched the correctional health care field. We applaud the 2011 recipients of these prestigious awards, which were presented Oct. 17 during the opening ceremony of the National Conference on Correctional Health Care, held in Baltimore. Bernard P. Harrison Award of Merit NCCHC’s highest honor, this award is presented to an individual or group that has demonstrated excellence and service that has advanced the correctional health care field, either through an individual project or a history of service. The award is named after NCCHC’s cofounder and first president. Steven Shelton Fred Cohen Steven R. Shelton, MD, CCHP-A Now in his 27th year at the Oregon Department of Corrections, Dr. Steven Shelton is perhaps the longest tenured corrections medical director in the nation, having held that position for the past 18 years. His longevity is no fluke. Dr. Shelton is renowned for exceptional performance as a leader, innovator and advocate for correctional health care. His efforts benefit not only his own system but also, through education, information sharing and mentorship, systems across the country. Dr. Shelton’s correctional career began in 1984 when he joined ODOC as staff physician. Formerly a nurse, he had attained an MD degree a few years earlier and was working in community settings, including his own urgent care clinic. In the early days he would see inmates in the morning hours when his private practice was closed. As the prison system and health care needs expanded, so did his involvement. Over time he became staff physician at five prisons and chief medical officer at two prisons, and in 1993 he became the system’s medical director. Among his achievements, Dr. Shelton developed the concept known as therapeutic levels of care, which uses defined standards and case discussion to determine the medical necessity of various treatments. Because this approach was adopted by the state’s medical assistance program, it ensures that inmates receive a community standard of care. Dr. Shelton also developed nursing protocols for early first-line intervention. Both approaches have been used in many other systems. He also transformed processes—and attitudes—related to patient sick call and self-care. The man behind these innovations possesses a rich combination of traits that has earned him the devotion of his staff and respect of his peers. One hallmark of his leadership is his success in building a staff of highly capable clinicians. He is committed to professional development and mentorship, and oversees a continuing education program that draws clinicians from county jails and neighboring states. He also nurtures strong relationships with specialty providers. “He is an exemplary role model. No staff members leave and they just keep getting better in their practices,” says a colleague. He also models creativity, empathy and, in every sense of the word, caring. Despite his high-level role overseeing health services for 14,000 inmates, Dr. Shelton continues to practice direct patient care. With all 13 ODOC facilities accredited, Dr. Shelton is closely allied with NCCHC’s mission. He also strives to help the field. He lends his expertise as a physician surveyor for NCCHC’s accreditation program, and his educational presentations are too numerous to count. He fosters professionalism by serving on the Certified Correctional Health Professional program’s board of trustees. He himself has been a CCHP since 1993, earning Advanced status four years later. He also is a charter member of the Society of Correctional Physicians and has served as its president. Overall, Dr. Shelton has organized an outstanding system of health services and staff development that has improved health care access, utilization and patient satisfaction. He gives generously to the correctional health community, sharing his knowledge at all turns. He excels at building alliances for the betterment of all. B. Jaye Anno Award of Excellence in Communication This award pays tribute to innovative, well-executed communications that have had a positive impact on the field of correctional health care, or to individuals for bodies of work. The award is named after NCCHC’s cofounder and first vice president. Fred Cohen, LLM Correctional professionals who need to stay abreast of important court rulings—but don’t have time to pore over the arcane details of myriad lawsuits—know exactly where to turn: the Correctional Law Reporter. Launched 22 years ago by Fred Cohen, LLM, and his longtime collaborator William Collins, JD, this bimonthly newsletter, first produced at a kitchen table, soon grew into the most respected periodical of its kind. It also was the catalyst for the formation a year later of the Civic Research Institute, which continues today as an independent publisher of reference and practice materials for professionals in the social sciences and law. A national authority on correctional health law, Mr. Cohen possesses special expertise in mental health law and is the author of the two-volume reference work The Mentally Disordered Inmate and the Law, now in its second edition, as well as executive editor of the Correctional Mental Health Report. He also has written numerous case books, treatises and articles on law and deviance. Mr. Cohen’s vast knowledge of these topics developed over a long career that encompasses many aspects of corrections and the law. A graduate of Yale Law School, he has been a full professor at a number of leading law schools and is a founder of the Graduate School of Criminal Justice, State University of New York at Albany, where he developed the law component of its PhD program. He has been the court-appointed monitor in several lawsuits pertaining to correctional mental health, medical and dental care in 8 Fall 2011 • CorrectCare www.ncchc.org Ohio, and has conducted investigations or served as a consultant in several other states, often on mental health topics. He also was a reporter to the American Bar Association’s Juvenile Justice Standards Project and served on the ABA task force revising correctional standards. Characteristically, Mr. Cohen’s response upon notification of the award was humble and humorous: “I am surprised and honored to receive the Anno Award. Writing is an isolated activity and to learn in this fashion that someone is reading and applauding is wonderful.” NCCHC Facility of the Year Award This prestigious award is presented to one facility selected from among the nearly 500 prisons, jails and juvenile facilities accredited by NCCHC. Lehigh County Prison, Allentown, Pennsylvaniai This year marks 25 years since Lehigh County Prison attained initial NCCHC accreditation, but this silver anniversary is not why the facility is being honored as Facility of the Year. Rather, it is in recognition of current excellence in health services delivery, continuity of care and staff professionalism. Despite its name, Lehigh County Prison functions as a maximum-security jail and is surveyed under NCCHC’s jail standards. Its latest accreditation survey found 100% compliance with applicable standards. That level of achievement is common for the facility, which has an average daily population of about 1,100 and annual admissions of about 5,600. Since 2003, the facility has used a contract management company to provide integrated medical, dental and mental health services. Health staff are on site around the clock. The team has frequent meetings to discuss administrative, nursing and quality improvement issues, and someone from facility administration is always present and participates in problem solving decisions. With such a well-run operation, it is hard to single out specifics to highlight. Among the areas that receive high marks are chronic disease management, nursing care, diagnostic services, mental health, dental care, pharmacy services, infection control, emergency management and discharge planning. Receiving screening is always timely, and detainees are rapidly assessed for detoxification, suicidal ideation and medication needs. Likewise, initial health assessments are consistently timely. Each inmate also receives an annual examination. One way to assess performance is through customer satisfaction, and here Lehigh County Prison shines: The facility receives health care grievances from less than 2% of the population. Such excellence doesn’t arise overnight. In this case, 25 years of continuous compliance with the standards has cultivated a workplace where staff pride and dedication to quality are the norm. This culture also depends on the example set by the warden and assistant warden, both of whom have served at the facility for more than 20 years. Under their strong, steady leadership, the facility has established a stable health services department with a solid history of performance. NCCHC Program of the Year Award This award recognizes programs of excellence among the thousands provided by accredited prisons, jails and juvenile facilities. “The Group” Weight Reduction Program Wyoming Honor Conservation Camp, Newcastle That sloped walk up to the health services building turned out to be a good thing for a couple dozen inmates at the Wyoming Honor Conservation Camp. After complaints by certain individuals about shortness of breath and sore legs, the warden concluded that their excess weight and overall poor health were the culprits. He asked the health services team to come up with a plan. Thus was born Self-HeLP (Healthy Lifestyles Program), an effort known as “The Group.” Part of the Wyoming Department of Corrections, WHCC provides vocational, educational and other programming to an average daily population of about 300 men. Although Lehigh County Prison exercise activities have long been offered, The Group was conceived in July 2010. It has evolved since the early days of informal meetings with a small group of inmates referred by health staff. As it became clear that many of the men did not understand the concept of self-care for chronic conditions or how lifestyle choices affect health, the education component became formalized. An important milestone occurred in September 2010, when health staff began to record participant weight, blood pressure and other health measures at each weekly meeting. Another major step was in December, when the recreational activities specialist added structured exercise to the program. To ensure privacy, because some participants would have been reluctant to exercise with other inmates present, the warden approved use of the gym during count time. In addition, the food service department was enlisted to provide healthy choices for meals and snacks. These foods are Wyoming Honor Conservation Camp available to all inmates. Although the total number of participants is small, their results are impressive. A July 2011 report noted a total of 196 pounds lost since recording began. Looking at individual outcomes, some of these men have made astonishing improvements. One lost more than 40 pounds in three months. Another reduced his LDL cholesterol from a whopping 547 to 167. A diabetes patient is no longer dependent on insulin. Many participants reduced their blood pressure. A bonus: These inmates also benefit from greater self-confidence, reduced anxiety and better social skills due to the support they give each other. Calling the program a “best practice for Wyoming corrections,” the DOC director is encouraging its implementation in other facilities. To see more photos from the awards ceremony, visit our Facebook page, facebook.com/NCCHC. 9 www.ncchc.org Fall 2011 • CorrectCare StrongerTogeth At Corizon, we work tirelessly to be the best provider of correctional healthcare. When our strength and dedication is paired with yours, we both find purpose. By working together, our collective vision becomes a reality. Innovations become customized solutions. Efforts become results. We provide care and service—to our clients, our patients and our communities. By working with us, you make it happen. And we’re both stronger together. www.corizonhealth.com ther Always striving. Ever better. KOP Glucometers in Prison? It’s Working Great in California by K. Ball, DO, CCHP The program is second nature now; all general population diabetes patients receive the glucometer kit and weekly exchange of supplies based on their provider’s recommendations A s chief medical executive at Calipatria State Prison, a maximum security male facility, I oversee health care for more than 4,000 inmates. In 2008, I had an idea for improving care for patients with diabetes. I felt that inmates needed to increase their responsibility in controlling their diabetes, and that if I could provide glucometers for self-monitoring, they would have better control and outcomes. After obtaining approval from the California Department of Corrections and Rehabilitation and my warden, I initiated a pilot program. Health program specialist Lita Martin and I spent many hours creating a local operating policy for the program. To determine what the policy needed to address, we considered all aspects of the program, such as choosing and issuing glucometers, dealing with damaged meters, exchanging supplies, patient refusals and parties responsible for program specifics. The glucometer and lancet device were selected based strictly on safety issues and, for the lancet device, also from a public health angle. We chose a self-retracting six-lancet device, feeling that it was somewhat tamperproof and so small that it could not be used as a weapon or for tattooing very well. For the glucometer, we picked a 17-strip barrel device. The barrel housing was acceptable to custody and also seemed tamperproof. For medical, we like the number of strips as it lessens the number of exchanges. During this process we also had discussions with custody about housing. Housing units typically rotate who is released first to chow. There had been complaints of delays in feeding after insulin was administered, leading to hypoglycemic events, and sometimes the insulin was given after chow instead of before. Given our concerns about irregular feeding times and delays in insulin administration, the warden approved my request that all diabetic inmates be housed in the same building on each yard and that they consistently be released first for meals. We believe this contributes to better control and fewer adverse outcomes. Policy Details The diabetes self-care program policy was approved in January 2009 and we announced our intentions to all staff. A team of health professionals educated medical staff affected by the program, explaining the details and expectations. The policy has evolved over time, with a few revisions to make it more practical. These are some of the highlights: • The primary care provider will issue a medical permit to each program participant allowing him to self-test and carry his diabetic supplies. The permit identifies the items that may be carried, such as glucometer, drums, cartridges, plastic carrying case, alcohol swabs, batteries, lancet device 12 Fall 2011 • CorrectCare www.ncchc.org and self-test diary. • Nursing staff conduct weekly logging of the glucometers and supplies distributed. The patient is assigned supplies based on the frequency of testing ordered by the primary care provider. Every Sunday, nursing collects all used drums and cartridges and distributes new ones (on a one-for-one basis) along with alcohol swabs as needed. They also inspect the glucometers for tampering or other problems. • The patient may dispose of the used strips and alcohol swabs in the regular trash. • Diabetic supplies are the property of the patient and will accompany the patient upon transfer to another institution or parole. • The initial glucometer and the weekly distribution of supplies are provided at no charge. If a glucometer is deliberately damaged, the patient may be required to purchase a replacement. • Custodial disciplinary action will be taken if any of the following occur: – Patient willfully damages or abuses the glucometer. – Patient tampers with the glucometer and/or diabetic supplies. – Diabetic supplies are missing. – A patient not enrolled in the program is found in possession of a glucometer or diabetic supplies. • To ensure that their insulin is readily accessible, type 1 diabetes patients will not receive job assignments that are off the institution grounds. • Any patient refusing to participate in the program completes a refusal of examination and/or treatment. The patient’s blood glucose levels will not be checked by nursing except when presenting with symptoms or prior to insulin administration. Our pilot facility was B yard, which has about 1,000 general population inmates. The goal was to enroll all 18 of the diabetic inmates into the program. To get started, a team of health professionals (chief physician, director of nursing, nurse supervisors, RNs, health program specialist and senior lab technologist) met with the inmates in a classroom setting. They presented general education on diabetes (basic physiology, monitoring calories, signs and symptoms, red flags) followed by in-depth teaching on glucometer use. Two patients refused participation, but later accepted. All participants signed consents demonstrating understanding of program participation, expectations and how supplies would be distributed. On this same day, we gave them the glucometers, medical permits and supplies. Signs of Success Data collected three months into the program showed mild improvements in patient health. The participants’ average HbA1c level decreased to 6.60 from 7.01 before the pilot. A sample look at blood glucose checks for one participant found an average pre-pilot level of 233; this decreased to 120 during the pilot. Analysis of the triage and treatment area log also suggests improved outcomes. In the 12-month period before the pilot, the 18 participants made 10 visits due to hypo/hyper- glycemic events; at the three-month assessment, no visits had been made. Diabetes-related emergency room visits also decreased. At three months we also conducted a survey of the 16 original participants. All replied “yes” in response to questions regarding satisfaction with the program, improved knowledge, improved health condition and better awareness of the diabetes disease process. In addition, 12 assigned a top score of 5 on a satisfaction rating scale, with the other participants assigning a rating of 4. The survey also yielded uniformly positive write-in comments from the patients, such as “Very good, thank you!”; “Glucometer helps [patient] control his diet, I dropped from 238 to 220 lbs!”; and “Very happy to be part of program!” (For anecdotal reports from the field, see box on page 14.) Given the success of the pilot, in fall 2009 we expanded the program to all of the general population yards. At the time we had about 200 diabetes patients (the number is now about 120). Again we began with education. The consent forms were signed and the glucometers were issued. The program is second nature now; all general population diabetes patients receive the glucometer kit and weekly exchange of supplies based on their provider’s recommendations for self-testing. (The glucometers are not allowed in the administrative segregation units, but I understand that the San Quentin prison has a pilot program in ad seg.) As far as more current data, this has been a bit difficult to obtain as only eight patients remain of the original pilot program. However, in October 2011 the average of all HbA1c levels in the general population was 6.81, reflecting an improvement from the average of 7.35 in 2008. Also, review of triage and treatment logs shows that the number of general population visits for hypoglycemic events was nine in 2006 but only one in 2010. What We’ve Learned I believe that the greatest benefit of the diabetes self-care program is the ability for the patients to take ownership of their chronic disease management. To self-monitor and manage their diabetes decreases their sense of helplessness and increases their autonomy. We were impressed to see the pride they took in the program, and to date we have had no reports of abuse. There have been very few refusals to participate; usually the refusals are from inmates who are in denial about their disease, and sometimes with time they accept and consent. The second greatest benefit is the impact on nursing. This program has reduced greatly the nurses’ workload because they used to do the blood glucose checks as ordered by the primary care provider. They still check prior to insulin administration or for symptomatic patients, but not at any other times, even for those refusing glucometers. The expenditure (about $10,000 per year) has not risen much because we used to give glucometers and supplies to diabetic inmates upon release; now it is an upfront cost. And we do see savings through reduced staff hours spent continued on page 14 13 www.ncchc.org Fall 2011 • CorrectCare Glucometers (continued from page 13) Reports From the Field Point to Success • Calls for diabetic care have changed from general to specific in nature. For example, instead of custody reporting that the inmate is not feeling well, the report may say, “The inmate said he is diabetic and his blood sugar is high; can you come and check him?” • Noticing a low number in a patient’s diabetic log, an RN asked what happened. He replied, “I was feeling sick and anxious so I checked my blood sugar before calling the officer. It was low so I ate something and felt better. I checked it again later and it was normal so I went back to bed without needing intervention.” • A patient reported, “I know that when I eat too much my blood sugar gets out of control for two or three days, so I’m paying more attention to what I eat.” • Another patient said, “I check my blood sugar to see if the medication is working; this reassures me.” • An RN observed that the patients do not see the glucometer as a toy but as an instrument that may help to save their lives. “I’m impressed with how carefully they treat the glucometer. I have not noticed any sabotage or tampering. I often perform the exchange of supplies and have no problems to report.” • Custody reports no problems with the pilot program. In fact, the associate warden for health care said, “This pilot has been successful.” with these patients, fewer complications and fewer ER visits. As far as program weaknesses, we would like the patients to be more faithful in keeping their dairies and bringing their glucometers or diaries to their clinic visits. Many only give recollections of their readings. We hope in the near future to add infrared readers to the providers’ computers; by waving the glucometer over the reader, all of the stored data will appear on screen for easier monitoring. Also, for more than a year we have asked that all patients bring all medications to every chronic care visit. I feel this would help the provider and the patient in the management of chronic diseases, including diabetes, but this has been a struggle to implement. But these glitches do not detract from the overall success and value of our diabetes self-care efforts. I recently gave a presentation on the program to a gathering of chief executive officers and chief medical executives from CDCR’s 33 adult institution. The CDCR’s federally appointed receiver so applauded our innovative vision and implementation of the program that he directed all 33 institutions to follow our lead. Since then, I have been part of a statewide committee helping to formulate a policy for statewide use. It is predicted that by early 2012, all diabetic inmates in the CDCR general population will have glucometers, and improved outcomes will follow. K. Ball, DO, CCHP, is the chief medical executive at Calipatria State Prison, part of the California Department of Corrections and Rehabilitation. NCCHC Accreditation Recognition From the Most Respected Name in Correctional Health Care For more than 30 years, NCCHC has worked with administrators across the country to ensure that health care provided in their facilities is effective, efficient, and meets constitutional requirements. Our success — and the success of facilities accredited by NCCHC — is unsurpassed. Leading the Way in Every Way ● ● ● ● ● NCCHC’s standards are widely recognized by the medical profession and the courts NCCHC’s standards are the benchmark for measuring a facility’s health services system NCCHC is unmatched in our correctional health care expertise NCCHC’s independence assures an unbiased evaluation of your compliance with standards NCCHC accreditation gives greater public confidence and professional satisfaction in the work you do No other accreditation comes close to receiving the professional acceptance and recognition that goes with NCCHC health services accreditation. Isn’t it time you became NCCHC accredited? For more information on NCCHC accreditation, contact us at: (773) 880-1460 • accreditation@ncchc.org • www.ncchc.org Accreditation Ad 2011 half.v CC.indd 1 14 Fall 2011 • CorrectCare 7/14/11 12:11 PM www.ncchc.org REYATAZ is a registered trademark of Bristol-Myers Squibb. ©2011 Bristol-Myers Squibb, Princeton, NJ 08543, U.S.A. 687US11VC07201 08/11 Printed in U.S.A. The Right Way to Deal With Outside Physicians by Jeffrey E. Keller MD T hose of us who practice medicine in jails frequently (Frequently? Daily!) run into the thorny issue of our relationship to the doctors who care for our patients outside of the jail. When patients are in our jails, we are responsible for them; they are our patients. But these patients also have doctors outside of the jail that perhaps they have been seeing for years. The inmate considers their outside physician to be their “real” doctor, not us. (Throughout this article, I am going to use the term “doctors” rather than the more generic “practitioners.” I do not mean to slight nurse practitioners or physician assistants. What I say applies to them, as well.) What brought this topic to mind is a case that occurred in one of my jails recently. A patient came to jail with a prescription pad filled out by his outside physician authorizing him to have a double mattress, an extra blanket and an extra pillow. (There was no note requiring us to feed him pizza every Friday night—he must have forgotten to ask for that.) So I was left in a little dilemma. What should I do about this note? Ignore it? Allow the inmate to have the extra comfort items? Dealing with inmates’ outside physicians can be tricky, but I have found (mostly through sad experience) that there is definitely a right way and a wrong way to handle these encounters. The right way involves recognizing three important points: 1. The outside physician is not authorized to write orders for patients in the jail; she does not have staff privileges in the jail setting. 2. Inmates like to pit the outside doctors against the jail doctors to get their way. It is a form of manipulation. It needs to be recognized as such. 3. The easiest and most time-effective way to defuse this situation is to speak to the outside physician directly and come to a joint decision of what will be done for the patient in jail. Staff Privileges The first core issue here that was misunderstood both by the patient and the outside physician is one of staff privileges. Just like hospitals, jails and prisons have a staff privilege system. If a patient of mine is admitted to the local hospital, I cannot write or call in orders. To be able to do so, I would have to formally apply for staff privileges at that hospital. Even then, I could not write orders for a patient at the hospital unless I was the admitting or attending physician. This staff privilege system is common to all medical establishments. I likewise cannot call in orders at the local nursing home or walk into the urgent care center across the street and start seeing patients. It is the same thing at a jail or a prison. To practice medicine in a correctional facility, a physician must be granted staff privileges at that facility. Who grants these privileges? The person with legal authority to operate the facility. In the case of almost all jails, that would be the sheriff and the jail administrator. What this means, of course, is that I, as the medical director of the jail, have no obligation to honor any outside physician’s orders. In fact, the outside physician cannot make orders; she has no staff privileges. If I or the other jail medical providers think that an outside physician’s recommendations are a good idea, we must rewrite the order; it has to come from us. On the other hand, if I, in my professional judgment, think that an order from an outside physician is inappropriate, I am under no obligation to follow it. I should, of course, document exactly why I made this decision so there is no question later. Inmate Manipulation But this does not solve the problem raised by this outside physician’s orders and the patient’s insistence that we have to follow them. What the patient is doing here is the classic and common inmate game of pitting two physicians against each other. This happens all of the time in jail. Inmates will say that their outside physician wants them to be on certain medications, have a special diet, wear their own shoes and so forth. If I, as the jail physician, say no to these requests, then the inmate feels that he or she has a legitimate grievance: “My outside doctor has prescribed X and you won’t let me have it. My outside doctor is my real doctor and knows me and my medical problems way better than you do.” This is a very common and sometimes successful method of inmate manipulation. If I do not recognize this as a type of manipulation, the inmate ends up becoming a spokesperson for the outside physician. Direct Communication By far, the best way to deal with this problem is to call the outside physician by telephone and come to common ground. I have found this to be quite easy and pleasant for the most part. Inmates paint their outside physicians as fanatically insistent upon the inmate getting what the inmate wants. But that is not true most of the time. Outside physicians are, for the most part, thoughtful, reasonable and helpful. And so it was in this case. I called the outside physician and explained the jail policy about extra mattresses and other comfort requests. She admitted that she didn’t 16 Fall 2011 • CorrectCare www.ncchc.org Three Key Principles To summarize, there are three principles of dealing with orders of a physician outside of the jail system: 1. Recognize that outside physicians do not have privileges to practice within the jail. You as the jail doctor may agree with their recommendations or disagree, but you are the ultimate decider. It is important for the inmate and the outside doctor to understand this. 2. Inmates tend to pit their outside physicians against the jail doctor as a type of manipulation to get what they want. This must be recognized as manipulation. 3. The best way to counter this manipulation and to defuse the whole situation is to speak personally with the outside physician and come up with a joint treatment plan for the inmate while in jail. know much about jail medical procedures and that she had written that note only because the patient begged her to. I asked if she would support me in my determination of appropriate housing for this patient’s medical condition and, of course, she agreed. By the end of the conversation, we were chatting like old comrades. I gave her my personal cell phone number in case she had any questions about future patients who might end up in jail. And finally, I could report to the patient that I had personally talked to his outside physician and that we had jointly developed a housing and treatment plan for him while he was in jail and this would not include an extra blanket, extra mattress or extra pillow. Problem solved. He is no longer able to play one doctor versus another. Added Benefits There are lots of added benefits to calling the outside physician in cases like this. It consumes much less time than fighting with the patient over the course of several clinic visits and grievances. It develops personal contacts in the outside medical community. If I have a question in this particular doctor’s field, I can call her for help. The doctor also knows more about the jail and jail medicine than she did before. We now have a rapport that will come in handy the next time one of her patients ends up in jail. The next time one of her patients asks her to authorize special treatment in jail, she will know not to do this (or at least to call me first). Note that requesting medical records would not have achieved the same results. In fact, requesting medical records would have accomplished nothing and wasted time. The act of calling and speaking personally to the outside physician is the key. As usual, this strategy worked wonderfully in this case. Once I told the inmate that his outside doctor and I agreed on the treatment he would receive in jail, he had nothing further to say. He never brought the subject up again. He never wrote a grievance. And this is such a common problem, I will probably use this strategy again tomorrow! Jeffrey E. Keller, MD, is the medical director of the Ada County Jail in Boise, ID, and the Bonneville County Jail in Idaho Falls, ID. He also is a frequent speaker at NCCHC conferences. Contact him at jkeller@badgermedicine.com. Medical Mental Health Dental Pharmacy 201 17th Street NW, Suite 300, Atlanta, GA 30363 404.760.0296 www.correctionalmed.com 17 www.ncchc.org Fall 2011 • CorrectCare Correctional Nursing Practice: What You Need to Know (Part 8) NCCHC’s Certified Correctional Health Professional program offers specialty certification for RNs. The CCHP-RN certification is the formal recognition of the specialized knowledge, skills and experience specific to the practice of nursing in a correctional setting. Whereas nursing licensure establishes legal authority for an individual to practice nursing, specialty certification reflects achievement of the special knowledge and skills needed for a particular practice area. This column, written by members of the CCHP-RN task force, discusses various areas of correctional nursing practice covered in the CCHP-RN exam outline. This will assist nurses preparing to take the exam as well as explain the key concepts of the specialty for the novice correctional nurse. Learn more about the CCHP-RN program and exam at www.ncchc.org/cchprn. Regulations, Standards and Policies To be identified as a profession, a discipline must meet criteria that include having established standards of practice and regulation of the practice. In the profession of nursing, regulation is an important component in ensuring safe and competent practice. Nursing consistently ranks No. 1 of all professions in Gallup’s annual honesty and ethics survey. Confidence is supported when nurses thoroughly understand and comply with all regulations and standards. As in the larger health care industry, correctional health care systems are subject to regulation. Importantly, laws and rules that pertain to nursing in the community also apply in the correctional setting. However, issues related to regulations, standards and compliance with nurse practice acts and scope of practice are not always well understood by correctional nurses and sometimes do not gain the expected level of knowledge, compliance and value. Because nursing practice has a significant impact on health care delivery, patient safety and patient outcomes, regulation of the profession and individual nursing practice is necessary. The practice of nursing is regulated at the state level through administrative rules (laws) and civil procedures. Licensure is one method of validating knowledge and competence. Individual states license and regulate the profession through their nursing boards, while the National Council of State Boards of Nursing works to create uniformity and consistency in nursing practice and standards. Many other government agencies—federal, state and local—also issue regulations, standards and guidance to assure safe and appropriate nursing care. At the federal level, the U.S. Department of Health and Human Services is the principal agency for protecting the health of citizens. HHS regulates through 11 divisions, including the Centers for Disease Control and Prevention, the Food and Drug Administration and the Office of the Inspector General. At present the Centers for Medicare and Medicaid Services has little impact on correctional health care, except, for example, when a facility receives federal funding, such as reimbursement for dialysis. However, that may change as provisions of the health care reform law are implemented. Correctional health systems and their employees are expected to comply with applicable laws and regulations. The monitoring and oversight of these systems may not be as visible as in health care settings in the community. Nevertheless, these functions are important. Correctional facilities have a federal mandate to provide appropriate health care for individuals detained and incarcerated. If a facility fails to ensure safety and fails to meet the serious medical needs of those incarcerated, this likely will lead to litigation and court monitoring. Several nongovernmental organizations also issue useful standards and other guidance. With respect to health care, the National Commission on Correctional Health Care’s Standards are the most recognized and well-accepted. Many facilities strive to meet these standards for accreditation even if they are not accredited because compliance improves quality and limits liability risk. Other organizations, such as the American Public Health Association, the American Nurses Association and the American Psychiatric Association, also publish standards and recommendations on aspects of health care in corrections. The correctional nurse must understand these standards and ensure that nursing practice is consistent with them. In all cases, measuring and monitoring systems is essential. Nurses must also understand and comply with the policies and procedures established at their facilities. Policies and procedures provide guidance, standardization and consistency in practices, and failure to comply places the nurse, patient and institution at risk. For example, the patient may be at risk of endangerment, while the nurse and institution may be subject to litigation if poor patient outcomes occur. Policy topics are wide ranging. Applicable laws and standards should be incorporated into institutional policies, procedures and protocols for the correctional nurse. For example, they should reflect federal and state regulations for reporting public health concerns, conditions of abuse, rape, communicable diseases, trauma, unexpected and expected deaths and care of the mentally ill. Regarding standards, NCCHC standards address topics such as access to care, quality improvement, grievance mechanisms, patient and staff safety, medication services, screening and assessment, patient restraint and much more. When developing policies, nurses are expected to know and understand the American Nurses Association’s standards for nursing practice, administrative nursing and the specialty of corrections nursing. Nurses and their leadership are held accountable to these standards as well as the nursing social policy statement and code of ethics. Mary V. Muse, MS, RN, CCHP-RN, CCHP-A, is chief nursing officer, Wisconsin Department of Corrections, Madison. This column is coordinated by Lorry Schoenly, PhD, RN, CCHPRN, an independent consultant specializing in correctional health care and social media; she is based in Pennsylvania. For correspondence, write to editor@ncchc.org. 18 Fall 2011 • CorrectCare www.ncchc.org The National Commission on Correctional Health Care and the Certified Correctional Health Professionals Board of Trustees are pleased to announce CCHP CERTIFICATION FOR REGISTERED NURSES l Specialty certification for nurses working in the correctional setting l Recognizing the work you do and the difference you make l Exclusively for nurses already CCHP certified l From the most widely accepted correctional health care certification program Certification in correctional nursing makes a difference—to the patients whose care is provided by certified correctional nurses, to employers who must staff their facilities with skilled and experienced correctional nurses, and to the individual nurse who attains the CCHP-RN© credential. Certification Makes a Difference – Do You? For more information or to obtain an application, visit our Web site at www.ncchc.org/cchprn. You may also contact us at cchp@ncchc.org or 773-880-1460. The first once-daily Single Tablet Regimen One tablet, once daily, alone or in combination, on an empty stomach, preferably at bedtime1 FOR ADULT PATIENTS WITH HIV-1 IN YOUR CORRECTIONAL FACILITY * … 3 MEDICATIONS IN 1 ADDS UP TO A COMPLETE HIV REGIMEN ATRIPLA can be used alone or in combination with other antiretroviral agents.1 ATRIPLA is the only DHHS-preferred HIV regimen available as 1 pill daily for antiretroviral-naïve patients.2 INDICATION • ATRIPLA is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults IMPORTANT SAFETY INFORMATION WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST-TREATMENT EXACERBATION OF HEPATITIS B • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (DF), a component of ATRIPLA, in combination with other antiretrovirals • ATRIPLA is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of ATRIPLA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued EMTRIVA® (emtricitabine) or VIREAD® (tenofovir DF), which are components of ATRIPLA. 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-1 and HBV and discontinue ATRIPLA. If appropriate, initiation of anti-hepatitis B therapy may be warranted *Pill not shown at actual size. DHHS = Department of Health and Human Services. References: 1. ATRIPLA Prescribing Information. Bristol-Myers Squibb & Gilead Sciences, LLC; March 2011. 2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 10, 2011. http://www.aidsinfo.nih.gov/contentfiles/ AdultandAdolescentGL.pdf. Accessed January 12, 2011. ATRIPLA is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, HEPSERA, TRUVADA, and VIREAD are registered trademarks of Gilead Sciences, Inc. SUSTIVA is a registered trademark of Bristol-Myers Squibb. All other trademarks are owned by third parties. ©2011 Gilead Sciences, Inc. All rights reserved. ST10118 08/11 Important Safety Information About ATRIPLA Contraindications • ATRIPLA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of ATRIPLA • Coadministration of ATRIPLA with bepridil, cisapride, midazolam, pimozide, triazolam, or ergot derivatives is contraindicated, since competition for CYP3A by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life-threatening adverse reactions • Concomitant use of ATRIPLA with voriconazole, atazanavir (with or without ritonavir), St. John’s wort (Hypericum perforatum) or St. John’s wort-containing products is not recommended Warnings and Precautions Coadministration with Related Products • Since ATRIPLA contains efavirenz, emtricitabine, and tenofovir DF, ATRIPLA should not be coadministered with SUSTIVA® (efavirenz), EMTRIVA, VIREAD, or TRUVADA® (emtricitabine/tenofovir DF). Due to similarities between emtricitabine and lamivudine, ATRIPLA should not be coadministered with drugs containing lamivudine, including Combivir ® (lamivudine/zidovudine), Epivir ® or Epivir-HBV® (lamivudine), Epzicom ® (abacavir sulfate/lamivudine), or Trizivir ® (abacavir sulfate/lamivudine/zidovudine) • ATRIPLA should not be administered with HEPSERA® (adefovir dipivoxil) Psychiatric Symptoms • 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 receiving efavirenz. In addition to efavirenz, factors identified in a clinical study that were associated with an increase in psychiatric symptoms included a 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 efavirenz was the cause. Patients with serious psychiatric adverse experiences should be evaluated immediately to determine whether the risks of continued therapy outweigh the benefits Nervous System Symptoms • Fifty-three percent of subjects 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 efavirenz compared to 25% of subjects 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 subjects, and 2.1% of subjects discontinued therapy. After 4 weeks of therapy, the prevalence of nervous system symptoms of at least moderate severity ranged from 5% to 9% in subjects treated with regimens containing efavirenz. Nervous system symptoms are not predictive of the less frequent psychiatric symptoms New Onset or Worsening Renal Impairment • It is recommended that creatinine clearance (CrCl) be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with ATRIPLA, and routine monitoring of CrCl and serum phosphorus be performed for patients at risk of renal impairment, including patients who have previously experienced renal events while receiving adefovir dipivoxil. ATRIPLA should not be given to patients with CrCl <50 mL/min. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir DF. ATRIPLA should be avoided with concurrent or recent use of a nephrotoxic agent Reproductive Risk Potential • ATRIPLA may cause fetal harm when administered during the first trimester to a pregnant woman. Women should not become pregnant or breastfeed while taking ATRIPLA. Barrier contraception must always be used in combination with other methods of contraception (eg, oral or other hormonal contraceptives). Because of the long half-life of efavirenz, adequate contraceptive measures are recommended for 12 weeks after discontinuation of ATRIPLA. If the patient becomes pregnant while taking ATRIPLA, she should be apprised of the potential harm to the fetus Please see Important Safety Information, including Boxed WARNINGS, for ATRIPLA and brief summary of Full Prescribing Information on adjacent pages. Rash • Mild-to-moderate rash is a common side effect of efavirenz. In controlled clinical trials, 26% of subjects treated with efavirenz experienced new-onset skin rash compared with 17% of subjects treated in control groups. ATRIPLA should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever Hepatotoxicity • Liver enzymes should be monitored before and during treatment in patients with underlying hepatic disease, including hepatitis B or C infection; in patients with marked transaminase elevations; and when ATRIPLA is administered with ritonavir or other medications associated with liver toxicity. A few of the postmarketing reports of hepatic failure, including cases in patients with no preexisting hepatic disease or other identifiable risk factors, were characterized by a fulminant course, progressing in some cases to transplantation or death. Liver enzyme monitoring should be considered for patients without pre-existing hepatic dysfunction or other risk factors Decreases in Bone Mineral Density • Bone mineral density (BMD) monitoring should be considered for patients who have a history of pathologic bone fracture or are at risk for osteopenia. Decreases in BMD have been seen with tenofovir DF. Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures) have been reported in association with the use of tenofovir DF Seizure • Use ATRIPLA 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 Immune Reconstitution Syndrome • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of ATRIPLA Fat Redistribution • Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy Adverse Reactions • In Study 934, through 144 weeks, the most frequently reported Grades 2-4 adverse reactions reported in ≥5% of subjects receiving efavirenz + emtricitabine + tenofovir DF were diarrhea (9%), nausea (9%), fatigue (9%), depression (9%), dizziness (8%), sinusitis (8%), upper respiratory tract infection (8%), rash event (7%), headache (6%), insomnia (5%), anxiety (5%), and nasopharyngitis (5%) • The most common adverse reactions (incidence ≥10%, any severity) occurring in Study 934 include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash • Skin discoloration, associated with emtricitabine, may also occur Drug Interactions • Coadministration of ATRIPLA with didanosine should be undertaken with caution. Patients receiving this combination should be monitored closely for didanosine-associated adverse reactions • Lopinavir/ritonavir has been shown to increase tenofovir concentrations. Patients on lopinavir/ritonavir plus ATRIPLA should be monitored for tenofovirassociated adverse reactions. ATRIPLA should be discontinued in patients who develop tenofovir-associated adverse reactions • Coadministration of ATRIPLA and atazanavir is not recommended. Efavirenz and tenofovir DF have been shown to decrease concentrations of atazanavir. Atazanavir has also been shown to increase tenofovir concentrations • Saquinavir should not be used as the only protease inhibitor in combination with ATRIPLA See Full Prescribing Information for complete list of drug-drug interactions. Hepatic Impairment • ATRIPLA is not recommended for patients with moderate or severe hepatic impairment because of insufficient data; use caution in patients with mild hepatic impairment Dosage and Administration • The dose of ATRIPLA is 1 tablet (containing 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir DF) once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms. ATRIPLA is not recommended for use in patients <18 years of age or in patients with CrCl <50 mL/min F SFB0001A_AtrpBrf0311_7x9wip2_live 6/2/11 5:06 PM Page 1 ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets Brief Summary of Prescribing Information. For complete prescribing information consult official package insert. WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST-TREATMENT EXACERBATION OF HEPATITIS B Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of ATRIPLA, in combination with other antiretrovirals [See Warnings and Precautions]. ATRIPLA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of ATRIPLA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued EMTRIVA or VIREAD, two of the components of ATRIPLA. 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-1 and HBV and discontinue ATRIPLA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [See Warnings and Precautions]. INDICATIONS AND USAGE ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. CONTRAINDICATIONS ATRIPLA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., StevensJohnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of ATRIPLA. Contraindicated Drugs: For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions. Drugs that are contraindicated or not recommended for use with ATRIPLA include: bepridil, cisapride, midazolam, pimozide, triazolam, voriconazole, ergot derivatives, or St. John’s wort (Hypericum perforatum). WARNINGS AND PRECAUTIONS 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 including tenofovir DF, a component of ATRIPLA, 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 ATRIPLA 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-1 and HBV: It is recommended that all patients with HIV-1 be tested for the presence of chronic HBV before initiating antiretroviral therapy. ATRIPLA is not approved for the treatment of chronic HBV infection, and the safety and efficacy of ATRIPLA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, two of the components of ATRIPLA. In some patients infected with HBV and treated with emtricitabine, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Patients who are coinfected with HIV-1 and HBV should be closely monitored with both clinical and laboratory follow up for at least several months after stopping treatment with ATRIPLA. If appropriate, initiation of anti-hepatitis B therapy may be warranted. ATRIPLA should not be administered with HEPSERA® (adefovir dipivoxil) [See Drug Interactions]. Drug Interactions: Efavirenz plasma concentrations may be altered by substrates, inhibitors, or inducers of CYP3A. Likewise, efavirenz may alter plasma concentrations of drugs metabolized by CYP3A [See Contraindications and Drug Interactions]. Coadministration with Related Products: Related drugs not for coadministration with ATRIPLA include EMTRIVA (emtricitabine), VIREAD (tenofovir DF), TRUVADA (emtricitabine/tenofovir DF), and SUSTIVA (efavirenz), which contain the same active components as ATRIPLA. Due to similarities between emtricitabine and lamivudine, ATRIPLA should not be coadministered with drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir, or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine). Psychiatric Symptoms: Serious psychiatric adverse experiences have been reported in patients treated with efavirenz. In controlled trials of 1008 subjects treated with regimens containing efavirenz for a mean of 2.1 years and 635 subjects treated with control regimens for a mean of 1.5 years, the frequency (regardless of causality) of specific serious psychiatric events among subjects who received efavirenz 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%). 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 efavirenz and control treatment groups. In Study 006, onset of new serious psychiatric symptoms occurred throughout the study for both efavirenz-treated and control-treated subjects. One percent of efavirenz-treated subjects 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 efavirenz 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 efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits [See Adverse Reactions]. Nervous System Symptoms: Fifty-three percent (531/1008) of subjects receiving efavirenz in controlled trials reported central nervous system symptoms (any grade, regardless of causality) compared to 25% (156/635) of subjects receiving control regimens. These symptoms included dizziness (28.1% of the 1008 subjects), insomnia (16.3%), impaired concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%), and hallucinations (1.2%). Other reported symptoms were euphoria, confusion, agitation, amnesia, stupor, abnormal thinking, and depersonalization. The majority of these symptoms were mild-moderate (50.7%); symptoms were severe in 2.0% of subjects. Overall, 2.1% of subjects 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 subjects treated with regimens containing efavirenz and from 3% to 5% in subjects 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 and Precautions]. Dosing at bedtime may improve the tolerability of these nervous system symptoms [See Dosage and Administration (2) in Full Prescribing Information]. Patients receiving ATRIPLA should be alerted to the potential for additive central nervous system effects when ATRIPLA 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. New Onset or Worsening Renal Impairment: Emtricitabine and tenofovir are principally eliminated by the kidney; however, efavirenz is not. Since ATRIPLA is a combination product and the dose of the individual components cannot be altered, patients with creatinine clearance <50 mL/min should not receive ATRIPLA. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir DF [See Adverse Reactions]. It is recommended that creatinine clearance be calculated in all patients prior to initiating therapy and as clinically appropriate during therapy with ATRIPLA. Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed in patients at risk for renal impairment, including patients who have previously experienced renal events while receiving HEPSERA. ATRIPLA should be avoided with concurrent or recent use of a nephrotoxic agent. 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 ATRIPLA. Barrier contraception must always be used in combination with other methods of contraception (e.g., oral or other hormonal contraceptives). Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of ATRIPLA is recommended. Women of childbearing potential should undergo pregnancy testing before initiation of ATRIPLA. 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 of ATRIPLA in pregnant women. ATRIPLA 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. Antiretroviral Pregnancy Registry - To monitor fetal outcomes of pregnant women, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients who become pregnant by calling (800) 258-4263. Rash: In controlled clinical trials, 26% (266/1008) of subjects treated with 600 mg efavirenz experienced new-onset skin rash compared with 17% (111/635) of subjects treated in control groups. Rash associated with blistering, moist desquamation, or ulceration occurred in 0.9% (9/1008) of subjects treated with efavirenz. The incidence of Grade 4 rash (e.g., erythema multiforme, Stevens-Johnson syndrome) in subjects treated with efavirenz in all studies and expanded access was 0.1%. Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 2 weeks of initiating therapy with efavirenz (median time to onset of rash in adults was 11 days) and, in most subjects continuing therapy with efavirenz, rash resolves within 1 month (median duration, 16 days). The discontinuation rate for rash in clinical trials was 1.7% (17/1008). ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) can be reinitiated in patients interrupting therapy because of rash. ATRIPLA 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. Hepatotoxicity: Monitoring of liver enzymes before and during treatment is recommended for patients with underlying hepatic disease, including hepatitis B or C infection; patients with marked transaminase elevations; and patients treated with other medications associated with liver toxicity [See also Warnings and Precautions]. A few of the postmarketing reports of hepatic failure occurred in patients with no pre-existing hepatic disease or other identifiable risk factors [See Adverse Reactions]. Liver enzyme monitoring should also be considered for patients without pre-existing hepatic dysfunction or other risk factors. 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 ATRIPLA needs to be weighed against the unknown risks of significant liver toxicity [See Adverse Reactions]. Decreases in Bone Mineral Density (BMD): BMD monitoring should be considered for HIV-1-infected subjects who have a history of pathologic bone fracture or are at risk for osteopenia. If bone abnormalities are suspected then appropriate consultation should be obtained. In a 144-week study of treatment-naive subjects receiving tenofovir DF, decreases in BMD were seen at the lumbar spine and hip in both arms of the study. There was a significantly greater mean percentage decrease from baseline in BMD at the lumbar spine in subjects receiving tenofovir DF + lamivudine + efavirenz compared with subjects receiving stavudine + lamivudine + efavirenz. Changes in BMD at the hip were similar between the two treatment groups. Twenty-eight percent of tenofovir DF-treated subjects vs. 21% of the comparator subjects 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 subjects in the tenofovir DF group and 6 subjects in the comparator group. Tenofovir DF was associated with significant increases in biochemical markers of bone metabolism, suggesting increased bone turnover. Serum parathyroid hormone levels and 1,25 vitamin D levels were also higher in subjects receiving tenofovir DF. For additional information, consult the tenofovir DF prescribing information. Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures) have been reported in association with the use of tenofovir DF [See Adverse Reactions]. 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 Drug Interactions]. Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of ATRIPLA. 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. 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. ADVERSE REACTIONS Efavirenz, Emtricitabine and Tenofovir DF - The following adverse reactions are discussed in other sections of the labeling [See Boxed Warning and Warnings and Precautions]: Lactic acidosis and severe hepatomegaly with steatosis, severe acute exacerbations of hepatitis B, psychiatric symptoms, nervous system symptoms, new onset or worsening renal impairment, rash, hepatotoxicity, decreases in BMD, and immune reconstitution syndrome. 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. Adverse Reactions from Clinical Trials Experience: Study 934 was an open-label active-controlled study in which 511 antiretroviral-naive subjects received either emtricitabine + tenofovir DF administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254). Grades 2–4 adverse reactions, based on treatment-emergent adverse events, at a frequency ≥5% in subjects receiving efavirenz, emtricitabine and tenofovir DF and zidovudine/lamivudine + efavirenz (active control) through 144 weeks, respectively, were: diarrhea (9%, 5%), nausea (9%, 7%), fatigue (9%, 8%), depression (9%, 7%), dizziness (8%, 7%), sinusitis (8%, 4%), upper respiratory tract infections (8%, 5%), nasopharyngitis (5%, 3%), rash event (7%, 9%), headache (6%, 5%), insomnia (5%, 7%), anxiety (5%, 4%), and vomiting (2%, 5%). In Study 934, the most common adverse reactions (incidence ≥10%, any severity) for components of ATRIPLA, included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. In Study 073, subjects with stable, virologic suppression on antiretroviral therapy and no history of virologic failure were randomized to receive ATRIPLA or to stay on their baseline regimen. The adverse reactions observed in Study 073 were generally consistent with those seen in Study 934 and those seen with the individual components of ATRIPLA when each was administered in combination with other antiretroviral agents. In addition to the adverse reactions in Study 934 and Study 073 the following adverse reactions were observed in clinical trials of efavirenz, emtricitabine, or tenofovir DF in combination with other antiretroviral agents. Efavirenz - The most significant adverse reactions observed in subjects treated with efavirenz are nervous system symptoms, psychiatric symptoms, and rash [See Warnings and Precautions]. Selected adverse reactions of moderatesevere intensity observed in ≥2% of efavirenz-treated subjects in two controlled clinical trials included pain, impaired concentration, abnormal dreams, somnolence, anorexia, dyspepsia, abdominal pain, nervousness, and pruritus. Pancreatitis has also 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 subjects treated with efavirenz 600 mg than in control subjects. Emtricitabine and Tenofovir DF - Adverse reactions that occurred in at least 5% of treatment-experienced or treatmentnaive subjects receiving emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials include 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 emtricitabine-treated subjects. Laboratory Abnormalities: Efavirenz, Emtricitabine and Tenofovir DF - Laboratory abnormalities observed in Study 934 through 144 weeks were generally consistent with those seen in previous studies; significant observations in ≥1% of subjects include: any ≥Grade 3 laboratory abnormality (30%, 26%), fasting cholesterol (>240 mg/dL) (22%, 24%), creatine kinase (males >990 U/L, females >845 U/L) (9%, 7%), serum amylase (>175 U/L) (8%, 4%), alkaline phosphatase (>550 U/L) (1%, 0%), AST (males >180 U/L, females >170 U/L) (3%, 3%), ALT (males >215 U/L, females >170 U/L) (2%, 3%), hemoglobin (<8.0 mg/dL) (0%, 4%), hyperglycemia (>250 mg/dL) (2%, 1%), hematuria (>75 RBC/HPF) (3%, 2%), glycosuria (≥3+) (<1%, 1%), neutrophils (<750 mm3) (3%, 5%), and fasting triglycerides (>750 mg/dL) (4%, 2%) in tenofovir DF group and zidovudine group, respectively. Laboratory abnormalities observed in Study 073 were generally consistent with those in Study 934. Additionally, Grade 3/4 elevations of bilirubin (>2.5 x ULN), pancreatic amylase (>2.0 x ULN), serum glucose (<40 or >250 mg/dL), and serum lipase (>2.0 x ULN) occurred in up to 3% of subjects treated with emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials. Postmarketing Experience: The following adverse reactions have been identified during postapproval use of efavirenz, emtricitabine, or tenofovir DF. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Efavirenz - Abnormal coordination, abnormal vision, aggressive reactions, agitation, allergic reactions, arthralgia, asthenia, ataxia, cerebellar coordination and balance disturbances, constipation, convulsions, delusions, dyspnea, emotional lability, erythema multiforme, flushing, gynecomastia, hepatic enzyme increase, hepatic failure, hepatitis, hypercholesterolemia, hypertriglyceridemia, hypoesthesia, malabsorption, mania, myalgia, myopathy, neuropathy, neurosis, palpitations, paranoia, paresthesia, photoallergic dermatitis, psychosis, redistribution/accumulation of body fat [See Warnings and Precautions], Stevens-Johnson syndrome, suicide, tinnitus, tremor, and vertigo. A few of the postmarketing reports of hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, were characterized by a fulminant course, progressing in some cases to transplantation or death. F SFB0001A_AtrpBrf0311_7x9wip2_live 6/2/11 5:06 PM Page 2 Emtricitabine - No postmarketing adverse reactions have been identified for inclusion in this section. Tenofovir DF - Abdominal pain, acute renal failure, acute tubular necrosis, allergic reaction including angioedema, asthenia, dyspnea, Fanconi syndrome, hepatic steatosis, hepatitis, hypokalemia, hypophosphatemia, increased amylase, increased creatinine, increased liver enzymes (most commonly AST, ALT, gamma GT), interstitial nephritis (including acute cases), lactic acidosis, muscular weakness, myopathy, nephrogenic diabetes insipidus, osteomalacia (manifested as bone pain and which may contribute to fractures), pancreatitis, polyuria, proteinuria, proximal renal tubulopathy, rash, renal failure, renal insufficiency and rhabdomyolysis. The following adverse reactions, listed above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia. DRUG INTERACTIONS Efavirenz: Efavirenz has been shown in vivo to induce CYP3A. Other compounds that are substrates of CYP3A may have decreased plasma concentrations when coadministered with efavirenz. In vitro studies have demonstrated that efavirenz inhibits CYP2C9, 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 that induce CYP3A activity (e.g., phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of efavirenz resulting in lowered plasma concentrations. Emtricitabine and Tenofovir DF: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, coadministration of ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) 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. Coadministration of tenofovir DF and didanosine should be undertaken with caution and patients receiving this combination should be monitored closely for didanosine-associated adverse reactions. Didanosine should be discontinued in patients who develop didanosine-associated adverse reactions. Suppression of CD4+ cell counts has been observed in patients receiving tenofovir DF with didanosine 400 mg daily. Atazanavir and lopinavir/ritonavir have been shown to increase tenofovir concentrations. ATRIPLA should be discontinued in patients who develop tenofovir-associated adverse reactions. Coadministration of atazanavir with ATRIPLA is not recommended. There are insufficient data to support dosing recommendations for atazanavir, with or without ritonavir in combination with ATRIPLA. Efavirenz, Emtricitabine and Tenofovir DF: Other important drug interaction information for ATRIPLA is summarized below. The drug interactions described are based on studies conducted with efavirenz, emtricitabine or tenofovir DF as individual agents or are potential drug interactions; no drug interaction studies have been conducted using ATRIPLA. The list includes potentially significant interactions, but are not all inclusive. 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 — Atazanavir: ↓atazanavir concentration, ↑tenofovir concentration. Coadministration of atazanavir with ATRIPLA is not recommended. Coadministration of atazanavir with either efavirenz or tenofovir DF decreases plasma concentrations of atazanavir. The combined effect of efavirenz plus tenofovir DF on atazanavir plasma concentrations is not known. Also, atazanavir has been shown to increase tenofovir concentrations. There are insufficient data to support dosing recommendations for atazanavir or atazanavir/ritonavir in combination with ATRIPLA. 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. 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 reactions. ATRIPLA should be discontinued in patients who develop tenofovir-associated adverse reactions. 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 (e.g., 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. CCR5 co-receptor antagonist — Maraviroc: ↓maraviroc concentration. Efavirenz decreases plasma concentrations of maraviroc. Refer to the full prescribing information for maraviroc for guidance on coadministration with ATRIPLA. NRTI — Didanosine: ↑didanosine concentration. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, 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. Coadministration of ATRIPLA and didanosine should be undertaken with caution and patients receiving this combination should be monitored closely for didanosine-associated adverse reactions. 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. Posaconazole: ↓posaconazole concentration. Avoid concomitant use unless the benefit outweighs the risks. 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 concentration 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 concentrations. Diltiazem dose adjustments should be guided by clinical response (refer to the full prescribing information for diltiazem). No dose adjustment of ATRIPLA is necessary when administered with diltiazem. Others (e.g., 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 CYP3A. The potential exists for reduction in plasma concentrations of the calcium channel blocker. Dose adjustments should be guided by clinical response (refer to the full 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 full prescribing information for the HMG-CoA reductase inhibitor for guidance on individualizing the dose. Hormonal contraceptives — Oral: Ethinyl estradiol/Norgestimate: ↓active metabolites of norgestimate. A reliable method of barrier contraception must be used in addition to hormonal contraceptives. Efavirenz had no effect on ethinyl estradiol concentrations, but progestin levels (norelgestromin and levonorgestrel) were markedly decreased. No effect of ethinyl estradiol/norgestimate on efavirenz plasma concentrations was observed. Implant: Etonogestrel: ↓etonogestrel. A reliable method of barrier contraception must be used in addition to hormonal contraceptives. The interaction between etonogestrel and efavirenz has not been studied. Decreased exposure of etonogestrel may be expected. There have been postmarketing reports of contraceptive failure with etonogestrel in efavirenz-exposed patients. Immunosuppressants — Cyclosporine, tacrolimus, sirolimus, and others metabolized by CYP3A: ↓immunosuppressant. Decreased exposure of the immunosuppressant may be expected due to CYP3A induction by efavirenz. These immunosuppressants are not anticipated to affect exposure of efavirenz. Dose adjustments of the immunosuppressant may be required. Close monitoring of immunosuppressant concentrations for at least 2 weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with ATRIPLA. Narcotic analgesic — Methadone: ↓methadone concentration. Coadministration of efavirenz in HIV-1 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. *Please see Full Prescribing Information (Table 4) for additional information; this list is not all inclusive. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category D [See Warnings and Precautions] Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV-1. 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-1 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. Hepatic Impairment: ATRIPLA is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data. Patients with mild hepatic impairment may be treated with ATRIPLA; however, 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 ATRIPLA to these patients [See Warnings and Precautions and Clinical Pharmacology (12.3) in Full Prescribing Information]. Renal Impairment: Because ATRIPLA is a fixed-dose combination, it should not be prescribed for patients requiring dosage adjustment such as those with moderate or severe renal impairment (creatinine clearance <50 mL/min) [See Warnings and Precautions]. OVERDOSAGE If overdose occurs, the patient should be monitored for evidence of toxicity, including monitoring of vital signs and observation of the patient’s clinical status; standard supportive treatment should then be applied as necessary. Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz. Hemodialysis can remove both emtricitabine and tenofovir DF, but is unlikely to significantly remove efavirenz from the blood. Efavirenz - Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions. Emtricitabine - Limited clinical experience is available at doses higher than the therapeutic dose. In one study single doses of emtricitabine 1200 mg were administered to 11 subjects. No severe adverse reactions were reported. Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether emtricitabine can be removed by peritoneal dialysis. Tenofovir DF - Limited clinical experience at doses higher than the therapeutic dose of tenofovir DF 300 mg is available. In one study, 600 mg tenofovir DF was administered to 8 subjects orally for 28 days, and no severe adverse reactions were reported. The effects of higher doses are not known. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of tenofovir DF, a 4-hour hemodialysis session removed approximately 10% of the dose. PATIENT COUNSELING INFORMATION and FDA-APPROVED PATIENT LABELING Drug Interactions: 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 ATRIPLA. ATRIPLA 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. Information for Patients: Patients should be advised that: ATRIPLA is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections; they should remain under the care of a physician when using ATRIPLA; the use of ATRIPLA has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination; patients should be advised to continue to practice safer sex and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood; patients should be advised never to re-use or share needles; the long-term effects of ATRIPLA are unknown; 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; ATRIPLA should not be coadministered with SUSTIVA, EMTRIVA, VIREAD, or TRUVADA, or drugs containing lamivudine, including Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir. ATRIPLA should not be administered with HEPSERA [See Warnings and Precautions]. Patients should also be advised that: • lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with ATRIPLA will be suspended in any patients who develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [See Warnings and Precautions]. • they should be tested for hepatitis B virus (HBV) before initiating antiretroviral therapy. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued EMTRIVA or VIREAD, which are the components of ATRIPLA. • renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported. ATRIPLA should be avoided with concurrent or recent use of a nephrotoxic agent [See Warnings and Precautions]. • decreases in BMD have been observed with the use of tenofovir DF; BMD monitoring may be performed in patients who have a history of pathologic bone fracture or at risk for osteopenia [See Warnings and Precautions]. • take ATRIPLA orally on an empty stomach and that it is important to take ATRIPLA on a regular dosing schedule to avoid missing doses. • central nervous system symptoms (NSS) are commonly reported during the first weeks of therapy with efavirenz. Dosing at bedtime may improve the tolerability of these symptoms, which are likely to improve with continued therapy. Patients should be alerted to the potential for additive effects when ATRIPLA is used concomitantly with alcohol or psychoactive drugs. Patients should be instructed that if they experience NSS they should avoid potentially hazardous tasks such as driving or operating machinery [See Warnings and Precautions and Dosage and Administration (2) in Full Prescribing Information]. • serious psychiatric symptoms have been reported in patients receiving efavirenz. If they experience severe psychiatric adverse experiences they should seek immediate medical evaluation. Patients should be advised to inform their physician of any history of mental illness or substance abuse [See Warnings and Precautions]. • a common side effect is rash. Rashes usually go away without any change in treatment. However, since rash may be serious, patients should be advised to contact their physician promptly if rash occurs. Reproductive Risk Potential: Women receiving ATRIPLA should be instructed to avoid pregnancy [See Warnings and Precautions]. A reliable form of barrier contraception must always be used in combination with other methods of contraception, including oral or other hormonal contraception. Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of ATRIPLA is recommended. Women should be advised to notify their physician if they become pregnant or plan to become pregnant while taking ATRIPLA. 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. Bristol-Myers Squibb & Gilead Sciences, LLC. Foster City, CA 94404 ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, HEPSERA and VIREAD are trademarks of Gilead Sciences, Inc. SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are registered trademarks of Bristol-Myers Squibb Company. Pravachol is a registered trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks of their respective owners. © 2011 Bristol-Myers Squibb & Gilead Sciences, LLC. ST9225 SF-B0001A-03-11 Based on: 21-937-GS-008 697US08PBS00205 March 2011 Facilityprofile Small Jail Makes Big Strides in Care by Jaime Shimkus I t was a cause for celebration at the San Miguel County Detention Center when it achieved NCCHC accreditation last July. The warden, Patrick Snedeker, even arranged a special meeting with the county commissioners during which the accreditation certificate was presented by NCCHC cofounder B. Jaye Anno, PhD, CCHP-A. Snedeker, who has been warden for eight years, had long set his sights on this goal for the jail, which is in Las Vegas, NM. “The people we serve are residents of our community and we are entrusted with a great deal of responsibility for them,” he says. “Health services is a critical component, so we want to reflect the best practices and national standards.” The fact that the jail is a small The health care team (L-R): Mark Maestas, accreditation instructor, Concepcion Peralta, medical officer, Deborah Johnson, pro- facility, with an average daily vider, Noemi Jauregui, health services administrator, Rita Torres, population of about 113, was president/CEO, and Brenda Calderon, medical officer. no deterrent. In fact, its small size and limited internal resources have been the catalyst for several innovative achievements aimed at improving care in a cost-effective manner. The accreditation process was set in motion about two years ago when a nonprofit agency, Health Care Partners Foundation, was contracted to assume full responsibility for provision of health services. (Mental health services are provided by the Behavioral Health Institute, a state-owned psychiatric hospital.) HCP had handled certain health management services for several years prior, but, says HCP president and CEO Rita Torres, “When we gained complete control of the medical units, we were able to establish policies and procedures based on NCCHC’s standards. We could then ensure that everything was being done appropriately.” At that time, Deborah Johnson, PA-NP, came on board as the facility’s medical care provider. She had been through the NCCHC accreditation process twice before while working at the New Mexico State Penitentiary and helped in bringing the jail into compliance with the standards. The whole team embraced the idea of becoming accredited, says Johnson. “We work really hard to deliver quality care.” Quality Through Collaboration Another way the jail is striving to improve quality is through creative partnerships. Case in point: Project ECHO, a telemedicine program offered through the University of New Mexico School of Medicine. The program was created to provide specialty care for chronic and complex diseases for community health clinics in rural and underserved areas, but Snedeker saw its value for incarcerated patients. Program officials agreed and now the jail has technology that enables access to telepsychiatry and about a dozen medical specialties, including hepatitis C. “It is difficult to provide specialty care in a small facility,” says Torres. “Project ECHO makes a tremendous difference in managing those high-risk cases, and it doesn’t cost us anything.” Better yet, case review by specialists has decreased costs by having expert opinion on what is medically appropriate. As an example, Johnson says that substituting pricey antipsychotics for older medications when appropriate has led to dramatic reductions in pharmaceutical expenditures. Also related to Project ECHO is an inmate peer assistance program being developed for jails with San Miguel serving as the pilot. It involves two types of activities. In one, inmates are trained to educate their peers on how to reduce hepatitic C and HIV risks related to injection drug use. In the other, inmates provide continuous suicide watch in the interim between checks by a corrections officer. The partnerships don’t stop at the state line. Due to a shortage of medical providers in New Mexico, Torres and Johnson have worked with Colorado State University, Pueblo, to develop a two-year residency and fellowship for its graduate nurse practitioner students. In the program, which began this year, students spend the first year in rotation through correctional facilities, including San Miguel, and the second year in a fellowship at a single site. The students will receive specialty training (including the NCCHC standards) through a community college near the jail. The Bottom Line The jail met yet another goal this year when it completed its transition to electronic medical records. “This will assist with continuity of care,” says Torres, “and will make it so much easier for maintaining accreditation.” As a whole, these efforts to improve quality of care also pay off financially. According to a June 2011 report on medical services, the medical budget has not increased in any of the past seven years and is actually below the 2004 level. In fact, cost savings have enabled the addition of services and staff, with an increase in patient medical visits for better continuity of care. Explaining the motivation for these forward-thinking efforts, Torres says, “We believe that with vulnerable populations such as inmates, if you have good continuity of care and good community partnerships, you can attain cost savings and good quality of care based on accreditation standards and best practices.” Jaime Shimkus is the editor of CorrectCare. Contact her at editor@ncchc.org 24 Fall 2011 • CorrectCare www.ncchc.org Newswatch Minor Drug Offenders Diverted From Seattle Jails A pilot program designed to reduce crime and save public safety dollars in Seattle will also reduce the number of drug offenders, many of them repeat offenders, booked into jails and sentenced to prisons. Launched in October in a downtown neighborhood, “law enforcement assisted diversion,” or LEAD, gives police officers the discretion to take nonviolent offenders engaging in low-level crimes such as public intoxication or drug possession straight to treatment in the community. King County’s prosecuting attorney says this approach is an evolution of the drug court model that takes the justice system out of the equation. The program will undergo evaluation to gauge its success. About 90% of arrests made by Seattle police are for possession or selling of small amounts of drugs so, if implemented citywide (or beyond), LEAD’s impact on jails could be significant. Grants from five private foundations are providing $4 million over four years to pay for services such as substance abuse treatment, housing assistance, job training and education. Primary sources: • stateline.org/live/details/story?contentId=612828 • npr.org/2011/11/25/142704483/treatment-not-jail-for-lowlevel-drug-crimes Florida Bill Targets Restraint of Pregnant Inmates Florida legislators have introduced a bill that would regulate the shackling of incarcerated pregnant women. Titled the Healthy Pregnancies for Incarcerated Women Act, SB 524 prohibits use of restraints on an inmate known to be pregnant during labor, delivery and postpartum recovery except in “an extraordinary circumstance.” Other provisions require that the accompanying corrections official remove all restraints at the request of the treating health care professional, and that the corrections official explain the extraordinary circumstance in writing within 10 days. A similar bill failed In the last session. The Department of Corrections said it already has guidelines for restraint of pregnant women and prohibits restraint of those in labor. Jails in the state, however, do not uniformly have such policies, according to an article in the Florida Independent, citing jail standards promulgated by the Florida Sheriffs Association. This topic has received much national attention in the news media and in reports by organizations such as the ACLU and the Rebecca Project for Human Rights, which has examined state policies on shackling and advocates for an end to this practice. NCCHC’s position statement calls for avoiding use of restraints during pregnancy, particularly labor and delivery, with eight specific recommendations. • Primary source: floridaindependent.com/56211 • Position statement: ncchc.org/resources Violence Reduction Through Knitting Yes, knitting, as in needles and yarn. And focused concentration, goal setting and accomplishment in a communal setting. Started by a retired community volunteer, a weekly, two-hour knitting group at the Jessup Pre-Release Unit, a male minimum-security penitentiary in Maryland, has seen success that surprised administrators. There’s a waiting list to join the group, in which inmates have learned how to make woolly hats and stuffed dolls. Ground rules for participation keep the men on their best behavior and, anecdotally, the warden has noticed reduced rates of violence. “My whs_2nd_NCCHC_ad.qxd 8/14/08 5:38 PM Page mind is on something soft and gentle,” said one inmate. • baltimoresun.com/features/bs-ae-knitting-behindbars-20111111,0,2032786.story 1 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, helping them to control costs without sacrificing quality of care, cutting corners, or inappropriately denying services. The pride we take in meeting your needs is plain to see. MEDICAL MENTAL HEALTH DENTAL PHARMACY STAFFING EMR UTILIZATION MANAGEMENT 412-937-8590 SALES@WEXFORDHEALTH.COM CLAIMS PROCESSING TELEMEDICINE 25 www.ncchc.org Fall 2011 • CorrectCare Triage Critical for Toothache Complaints Odontogenic pain (toothache) is common among inmates and often leads to requests for urgent care. However, scope of dental care provided varies widely as some facilities do not have dental clinics or dental professionals on site at all times. “[I]t is critical that midlevel providers and physicians triage and manage these patients until a dentist can resolve the problem,” write Jay Shulman, DMD, MSPH, and Donald Sauter, DDS, MPA, in the January 2012 issue of the Journal of Correctional Health Care. The article presents the etiology and diagnosis of toothache along with the authors’ opinion of the standard of care for patient management and several recommendations. Key points are summarized here. Common nontraumatic causes of tooth pain are tooth fractures, pulpitis (inflammation of living tissue within the tooth), decay through the enamel, abscess and cellulitis (diffuse inflammation of connective tissue caused by a spreading bacterial infection below the skin surface). All inmates experiencing dental pain should have access to timely and definitive dental treatment. Patients complaining of a toothache should be examined by a midlevel provider, physician or dentist within 24 hours. All facilities should have a triage protocol to assist nondental clinicians. The nondentist clinicians need to receive training by a dentist in how to conduct a competent, well-documented oral examination. From this information, the clinician can then separate patients who need expedited evaluation by a dentist from those who can be stabilized using analgesics and Subscribe Today antibiotics and then given a regular dental appointment. A consulting dentist should be available to assist in the triage when necessary. While palliation is appropriate at the time of the initial complaint, treatment by a dentist is necessary to resolve the problem. The article also provides guidance for treatment, including oral infections. Importantly, when the physical examination suggests no infection or a localized infection, antibiotics should not be given. Patients who are given antibiotics should be treated by a dentist while there is a therapeutic blood level of the antibiotic. A patient who returns with complaints after two days of antibiotic therapy needs immediate reevaluation by a midlevel provider, physician or dentist to determine if the infection is progressing to cellulitis or spreading to fascial spaces. Finally, progress of patients awaiting a dental appointment should be monitored with frequency consistent with the differential diagnosis. JCHC Volume 18, Issue 1 Nonviolent Communication Training and Empathy in Male Parolees — Elizabeth Marlow, PhD, C-FNP, Adeline Nyamathi, PhD, C-ANP, William Grajeda, RAS, Newt Bailey, Amanda Weber, and Jerry Younger Recidivism Rates Among Mentally Ill Inmates: Impact of the Connecticut Offender Reentry Program — Karen Kesten, MS, CCHP, Erin Leavitt-Smith, MA, LPC, Douglas Rau, PhD, Deborah Shelton, PhD, RN, NE-BC, CCHP, Wanli Zhang, PhD, Jesse Wagner, MA, and Robert Trestman, PhD, MD Compliance with Bloodborne Pathogen Standards at Eight Correctional Facilities — Everett Lehman, MS, Janice Huy, MS, Susan Viet, PhD, CIH, and Ahmed Gomaa, MD Editor Edit Guideline, Education, and Peer Comparison to Reduce Prescriptions of Benzodiazepines and Low-Dose Quetiapine in Prison — Rusty Reeves, MD VVisit JCHC’s website at An Innovative Approach to Pharmacy Management in a State Correctional System — Rita Marcoux, RPh, MBA, Jason Simeone, PhD, Matthew Colavita, and E. Paul Larrat, RPh, PhD John R. Miles, MPA http://jchc.sagepub.com • Subscribe online • Recommend to your librarian • Access a free sample issue online • Experience SAGE Journals Online powerful reference linking The Official Journal of the National Commission on Correctional Health Care Treatment of Odontogenic Pain in a Correctional Setting — Jay Shulman, DMD, MSPH, and Donald Sauter, DDS, MPA Exploring Scope of Practice Issues for Correctional Facility Nurses in Montana — Amanda White, BSN, and Laura Larsson, PhD, MPH, BSN Each issue also has a self-study exam that offers continuing education credit. Academy of Correctional Health Professionals members receive JCHC (print and online) as a benefit of membership. To learn how to obtain JCHC, contact Sage Publications: 800-818-7243, ext. 7100; order@sagepub.com; http://jchc.sagepub.com. 26 Fall 2011 • CorrectCare J08040450_1088084_JCHC_Ad_4.5x4.75.indd 1 4/17/2008 11:04:36 AM www.ncchc.org Clinicalbriefs Tooth Scaling May Reduce Heart Attack, Stroke In a study of more than 100,000 people in Taiwan, those who received tooth scaling by a dentist or dental hygienist had a 24% lower risk of heart attack and 13% lower risk of stroke compared to those who never had a cleaning. Protection was greatest in those who received scaling at least once a year. None of the participants, who were followed for an average of seven years, had a history of heart attack or stroke when the study began. Professional tooth scaling appears to reduce inflammation-causing bacterial growth that can lead to heart disease or stroke, according to a cardiology specialist quoted in Dentistry IQ’s article on the study, which was presented at the American Heart Association’s Scientific Sessions in November. • dentistryiq.com/index/display/article-display/ 6666867567/ articles/dentisryiq/hygiene-department/2011/11/scalingheart_health.html Hepatitis C Deaths Exceed HIV Deaths Analysis of death statistics from 1999 through 2007 found that the hepatitis C death rate surpassed that of HIV in about 2006, a function of death rates declining for HIV but rising for hepatitis C. The findings were reported by a Centers for Disease Control and Prevention researcher at the annual meeting of the American Association for the Study of Liver Diseases in November. These data probably underreport HCV mortality because many infections have not been diagnosed. Another study presented at the meeting suggested that as many as 800,000 new cases could be diagnosed under a proposed screening approach that uses universal testing by birth cohort (1945-1965). • medpagetoday.com/MeetingCoverage/AASLD/29552 ‘Epidemic’ of Prescription Painkiller Overdoses Deaths from overdoses of prescription painkillers have more than tripled in the past decade, according to a Nov. 1 report from the CDC. Overdoses involving narcotic pain relievers like hydrocodone, methadone, oxycodone and oxymorphone kill more Americans than heroin and cocaine combined, the CDC director said. Key factors are increased use of such painkillers for nonmedical reasons along with growing sales. The CDC also released an issue brief highlighting key public health issues related to prescription painkiller overdoses and science-based policy actions that can be taken to address them. These issues are recognized in NCCHC’s new position statement on the management of chronic pain in correctional settings. • Report: cdc.gov/vitalsigns/PainkillerOverdoses • Issue brief: cdc.gov/homeandrecreationalsafety/rxbrief • Position statement: ncchc.org/resources Promising Treatment for Rx Painkiller Addiction Sustained treatment with Suboxone (a combination of buprenorphine plus naloxone) reduces opioid abuse in people addicted to prescription painkillers, according to research by the National Institute on Drug Abuse, part of the National Institutes of Health. Published in the Archives of General Psychiatry, this was the first randomized largescale clinical trial using a medication for the treatment of prescription opioid abuse. Results show no added benefit from the addition of intensive opioid dependence counseling. Unfortunately, patients had a high rate of relapse once the medication was discontinued, indicating a need for more research on how to sustain recovery. • nida.nih.gov/newsroom/11/NR11-08.html Be a part of the solution. Opportunities include: Health Services Administrators, Psychiatrists, Physicians, Nurses, Directors of Nursing, Mental Health Professionals, Dentists, Nurse Practitioners and Regional Managers. To find out how you can be a part of the solution, visit us online at correctcaresolutions.com 27 www.ncchc.org Fall 2011 • CorrectCare Juvenilevoice Psychological First Aid for Youth The application of first aid for medical injury is ubiquitous. There is a well-established consensus for response to physical crisis. Unfortunately, says psychiatrist Carl Bell, MD, CCHP, the same is not true for mental crisis. But Bell would like to change that, and he thinks juvenile justice settings are optimal places to establish policies and procedures for psychological first aid. It’s not that the concept is unknown, says Bell, who has CHP’s foCus on CaRe management Has reduced ouR Costs.” –Joanie Shoemaker, Colorado Department of Corrections Per Offender Per Month Total* $140 $118.16 $98.17 $119.34 $109.96 $80 $20 FY04 FY06 FY08 FY10 *Actual data – results may vary + Innovative cost reduction strategies + Prior authorization and utilization management + Pharmacy management + Provider network development + care management + claims processing, reporting, and analysis + Quality improvement + Staffing solutions been writing about and presenting on the topic for at least a decade. Often psychological first aid is used in large-scale disasters or crises. But it is not applied routinely in juvenile settings, where so many youth are victims of trauma. According to a 2009 study of more than 26,000 adults in five states, 59% reported at least one adverse childhood experience (see Morbidity and Mortality Weekly Report, Dec. 17, 2010), and 9% reported five or more. This study excluded incarcerated people, and among that group prevalence of childhood trauma is most likely higher, Bell says. Based in Chicago, Bell is the director of the Institute for Juvenile Research and a clinical professor of psychiatry and public health at the University of Illinois School of Medicine. He also is president and chief executive officer of the Community Mental Health Council and Foundation. A founding member of the NCCHC board of directors, he has long served on the NCCHC juvenile health committee. Just as correctional staff receive regular first aid training, they also should be given training on psychological first aid, including how to recognize symptoms of trauma, Bell recommends. Upon being admitted to the facility, every youth would be screened for history of mental health trauma. Staff would also be on the alert for symptoms, both during screening and throughout the youth’s stay at the facility. When a youth in crisis is identified, the staff member would apply first aid based on guidelines for age and symptoms. “It is not counseling, not in-depth psychotherapy. It is very simple,” says Bell. For example, if a fifth-grader is disturbed by grief after witnessing a family member being killed, the response would be to help the child retain positive memories as he or she works through the more intrusive traumatic memories. Guidelines for psychological first aid are available from the National Child Traumatic Stress Network. Although they are designed for disaster and crisis situations, the principles apply to other settings, Bell says. In 2007 he served as an expert panel member in development of the Mental Health First Aid Guidelines Project for Traumatic Events of the ORYGEN Research Centre, University of Melbourne, Victoria, Australia. “Psychological first aid absolutely should be implemented routinely in juvenile justice settings—and all community settings, too,” says Bell. “It really does help.” Resources • Mental Health First Aid Guidelines, ORYGEN Research Centre, University of Melbourne, Victoria, Australia mhfa.com.au/cms 866.932.7185 • cHPdeLIVerS.com 28 CHP2283_CorrectCare_Ad_FINAL.indd 1 Fall 2011 • CorrectCare • Psychological First Aid Field Operations Guide, National Child Traumatic Stress Network nctsn.org/content/psychological-first-aid 3/7/2011 3:51:56 PM www.ncchc.org 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! Both Medi-Dose and TampAlerT can be easily identified using our MILT software ... providing complete labeling and log reporting, even bar coding! Medi-Dose® System 1 2 3 There’s no doubt about Medi-Dose and TampAlerT, proven in correctional facilities for over 30 years. 4 TampAlerT® System 2 1 3 5 Dispense medication into TampAlerT bottle. Twist TampAlerT cap onto bottle. EPS , INC. ® Responding to pharmacy packaging needs around the world A secure, tamper-evident seal adheres to the bottle when you twist-off the cap. Milton Building, 70 Industrial Drive Ivyland, PA 18974 800-523-8966, Fax: 800-323-8966 215-396-8600, Fax: 215-396-6662 www.medidose.com E-mail: info@medidose.com 6 CCHPpage 20th Anniversary a Smash Success! The buildup to the CCHP anniversary celebration was exciting, and now that it’s over we can sit back and enjoy the memories. Held during the National Conference on Correctional Health Care in October, activities included contests, prizes and a special luncheon featuring a stirring talk by NCCHC cofounder Jaye Anno, PhD, CCHP-A. With great knowledge, insight and humor, she recounted a brief history of NCCHC and the Certified Correctional Health You don’t need A CRYSTAL BALL You need A STRONG MALPRACtICe PRoGRAM The NSU Correctional Healthcare Program At nSu Healthcare, we understand the challenges you face as a correctional medical provider. the decisions you make today could become your legal headaches tomorrow. You need a comprehensive malpractice program that provides: • Broad medical malpractice coverage • Correctional specific risk management resources • Dedicated correctional claims management our program is endorsed by the Academy of Correctional Health Professionals and we offer premium discounts for nCCHC accredited facilities and ACHP member firms. Leave seeing the future to the tarot Card Readers. Have your broker to request a quote from nSu Healthcare today. NSU Healthcare specializes in the Medical Professional Liability, General Liability, and Umbrella/Excess insurance needs of the healthcare industry.and has partnered with the Academy of Correctional Health Professionals in this program. 425.450.1090 x5050 www.nsuiriskmanagement.com Professional program and highlighted the importance of professional certification in this challenging discipline. By the end of her talk, every attendee was even more proud to be a CCHP. That sense of accomplishment and pride was heightened with the screening of the winning entry in the “I Am a CCHP” video contest. Submitted by Patrick Vance, MPA, CCHP, the two-minute video is expertly produced and beautifully synthesizes Vance’s personal journey in this field and the larger lessons about the value of CCHP certification. Vance is a health services administrator at the Oregon Department of Corrections. His prize: free registration to the 2012 Updates conference. See his inspiring video at facebook.com/ncchc. Several drawings took place before the National Conference. The biggest prize—free registration to the conference—was set aside for a random drawing from the August group of CCHP examinees. Congrats to Matthew Meehan, LPN CCHP! In addition, 15 CCHPs won gifts such as dayplanners and business card holders with the CCHP logo. Find their names at ncchc.org/cchp/20years.html. Finally, those remarkable CCHPs who have participated in the program continuously for 20 years received a special enhancer to adorn their CCHP pin and let the world know of their accomplishment. Congratulations Are in Order! • The board of trustees welcomes Carol Shepard, BSN, CCHP, the top vote-getter in the August election. Shepard started in this field 23 years ago as a jail director of nursing and quickly rose through the ranks. Today she is regional vice president for Armor Correctional Health Services, West Palm Beach, FL. She has been a CCHP for 10 years and an accreditation surveyor for two years. • The board also congratulates the latest group of professionals to earn CCHP certification. Effective Oct. 1 our ranks grew with 135 new CCHPs and five new CCHPRNs. Find a list of their names at ncchc.org/cchp. CCHP Exam Dates February 18 Multiple regional sites May 20 San Antonio, TX August 18 Multiple regional sites October 21 Las Vegas, NV We are seeking additional sites for regional exams, as well as CCHPs to proctor the exams. If you would like to participate, contact the CCHP manager at 773-880-1460 or cchp@ncchc.org. Learn more at ncchc.org/cchp. 30 Fall 2011 • CorrectCare www.ncchc.org SUSTIVA and the SUNRISE LOGO are registered trademarks of Bristol-Myers Squibb ©2011 Bristol-Myers Squibb, Princeton, NJ 08543, U.S.A. 692US09AB00512 02/11 Fieldnotes This department features news and information from NCCHC’s supporting organizations and other partners that share our goal of promoting quality health care in correctional institutions. If your organization has news to share, please contact editor@ncchc.org, 773-880-1460. Board Member Receives Multiple Honors NCCHC board member Ryung Suh, MD, MPP, MBA, MPH, is enjoying a successful year. Suh, who joined the board in October 2010 representing the American College of Preventive Medicine, is CEO of a health care consulting and research firm based in Washington, DC; among other work, he also holds senior faculty positions at Georgetown University and other institutions. • He received the William Kane Rising Star Award at ACPM’s annual meeting in February. The award honors a member of ACPM who has demonstrated a commitment to preventive medicine and the potential to make significant contributions to the field of preventive medicine. • In June, Suh and Atlas Research cofounder Mark Chichester together were named the 2011 Small Business Person of the Year by the DC Chamber of Commerce. They were honored for their successes and commitment to the District of Columbia’s business community, and in particular their commitment to civil service and work to address health equity. • Also in June, Suh was elected to the board of trustees of the American Association of Public Health Physicians. AAPHP is a supporting organization of NCCHC. • Visit the “News” section at atlasresearch.us NCCHC Surveyor Receives Pharmacy Award Charles Lawrence, Sr., RPh, PD, CCHP, was honored by the Washington DC Pharmaceutical Association for outstanding community service. Lawrence developed and implemented policies and procedures in the DC Department of Corrections to ensure that its pharmacy services met all federal and local pharmaceutical codes. One of the most prestigious awards in the field of community pharmacy, the Bowl of Hygeia Award is presented annually by state pharmacist associations, including that in DC. It is sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations. Lawrence has served as a surveyor for NCCHC’s accreditation program since 1995. • pharmacist.com/Content/NavigationMenu/GrantsAwards/ BowlofHygeia/default.htm Past SCP President Receives Start Award Lynn Sander, MD, FSCP, CCHP, is this year’s recipient of the Armond Start Award, the highest honor a correctional physician can receive. It is presented by the Society of Correctional Physicians for leadership in correctional medicine, with criteria that include adherence to the highest ethical standards and dedication to research, publication and training. Sander has been involved in correctional health care for 25 years, serving as the medical director of the Denver County Jail and as a federal health monitor for the U.S. Department of Justice. A national advocate for the rights and health care of incarcerated patients, Sander is known for excellence in patient care and high standards in education and research. As president of SCP from 2005 to 2007, she brought the organization to a position of leadership. The award is named for the late Armond Start, the physician who founded SCP. In the photo above, Sander is pictured with SCP president Michael Puerini, MD, CCHP-A. Stay Informed With the Academy Insider The Academy of Correctional Health Professionals is launching a new resource. The Academy Insider is a weekly e-news brief that delivers timely, relevant news about correctional health care and related topics directly to your inbox. The Academy Insider is also available as a mobile application. For Apple iPhone and iPod Touch, go to the App Store, search for “MultiBriefs,” download the app free of charge and then add the Academy feed. Android phone users may access the app by searching for “MultiBriefs” at the Android Marketplace. In addition, a complete archive of past issues enables users to search for news on topics of interest and to explore the most popular past articles. • Subscribe: multibriefs.com/optin.php?achp • Archive: multibriefs.com/briefs/achp New Name for American Dietetic Association Effective January 1, the ADA will become the Academy of Nutrition and Dietetics. Founded in 1917, the ADA is the world’s largest organization of food and nutrition professionals. In announcing the change, the organization’s president cited consumer confusion about where to find the most qualified nutrition expertise. “An academy is ‘a society of learned persons organized to advance science,’” said Sylvia Escott-Stump, MA, RD, LDN. The new name “promotes the strong science background and expertise” of the members, who are primarily registered dietitians. “Nutrition science underpins wellness, prevention and treatment.... Adding ‘nutrition’ communicates our dedication to improving the nation’s health.” • www.eatright.org 32 Fall 2011 • CorrectCare www.ncchc.org Exhibitor Opportunity Updates in Correctional Health Care San Antonio • May 19-22 Correctional health professionals of all disciplines will convene in Alamo City, a perennial favorite conference destination, for Updates 2012. The meeting will feature a broad array of health topics plus a special series on the role of correctional health services in reentry programming and prevention of recidivism. Our highly motivated attendees come to advance their knowledge, earn continuing education credit and network with colleagues. They also come to connect with the many companies that can help them meet the challenges of providing quality care to incarcerated populations, exploring new ideas and proven solutions for managing the complex operational and clinical demands of health care delivery to inmates. Maximize the Opportunity With 2.3 million individuals incarcerated in the United States, serving their wide-ranging health care needs is a big business. In fact, the nation’s correctional facilities spend roughly $7 billion each year to provide this governmentmandated care. Just as in the community, services span the spectrum, from acute care to chronic disease management to routine care, including dental and mental health, along with substance abuse treatment, prevention and health education. That’s a big challenge—and a big opportunity for companies that serve this market. Build Relationships With the Best Our multidisciplinary audience is a microcosm of the health care field at large. They are the leaders—and emerging leaders—in this field. Connecting with these influential professionals extends your reach to the departments, facilities and staff they work with every day. Effective Outreach • Exhibitions are the #1 source for attendees who make purchasing decisions. • Exhibition leads cost 56% less to close than field sales calls. • Exhibitions allow you to reach an average of 88% of unknown prospects. Source: The Center for Exhibition Industry Research (CEIR) Exhibitor Benefits • 3 days of exhibit hall activities • 2 full conference registrations per 10’ x 10’ booth • Discounted full registration for up to 5 additional personnel • 75-word listing in the Final Program (deadline applies) • Electronic attendee lists for pre- and post-show marketing • Free basic listing in NCCHC’s online Buyers Guide • Discounted advertising in meeting programs & CorrectCare • Lead retrieval technology available for rental on site • Opportunity to participate in raffle drawings • Priority booth selection for the 2012 National Conference Sponsorship Opportunities Where Will You Find Your next Great hire? Find your next lead with the National Commission on Correctional Health Care mailing list, a proven tool to reach over 30,000 physicians, nurses, mental health care providers, medical directors, nurses and other allied health professionals and administrators. Pinpoint your audience by job title, work setting and demographics. No other marketing channel allows you such a targeted marketing opportunity. www.InfocusLists.com/Datacard/NCCHC Contact INFOCUS Today! THE ASSOCIATION LIST SOURCE Kerry Tranfa ktranfa@infocuslists.com 800.708.LIST (5478), ext 3247 www.InfocusLists.com Enhance your presence and maximize marketing dollars through these outstanding opportunities. • Premier programming: Educational sessions and breakfast/ luncheon programs give attendees a fresh experience while giving your company exclusive exposure. • Final proceedings: Marked with your company’s name, the flash drive enables attendees to continue their learning with the concurrent session PowerPoint presentations. • Exhibit Hall reception/luncheon/breaks: Attendees will appreciate your contribution as they gather in this highenergy center to mingle and network throughout the day. • Smaller opportunities with big impact: Promote your company name while enhancing the attendee experience by sponsoring the conference bags, lanyards, water bottles, badges, banners and more. • Customize your contribution. NCCHC will work with you to develop a personalized package tailored to your needs and your budget. Registration Information The Updates conference provides the perfect opportunity to meet with important contacts and raise your profile in this specialty field, so reserve your space now. Standard booth sizes are 10' x 10'; double-size and premium spaces are available. To obtain an Exhibitor Prospectus with details and a reservation form, email NCCHCexhibits@ncchc.org or call 773-880-1460. 34 Fall 2011 • CorrectCare www.ncchc.org Classifiedads MARKETPLACE Special Savings! 10% discounts are offered for Academy members (single copies) and bulk purchases of a single title. (Excludes alreadydiscounted items.) To order or for a catalog, visit www.ncchc.org or call 773-880-1460. Standards for Health Services in Juvenile Detention and Confinement Facilities (2011) This edition is modeled after the 2008 Standards for jails and prisons but takes into account the issues unique to juvenile settings and populations. The Juvenile Standards address nine general areas: health care services and support, inmate care and treatment, special needs and services, governance and administration, personnel and training, safety, health records, health promotion and medical-legal issues. This edition features a user-friendly format; standards on current issues such as patient safety and clinical performance enhancement; clear compliance indicators that define expected outcomes and aid in self-assessment; guidelines for facilities of various sizes; best practices recommendations; and appendices on legal obligations, quality improvement and more. Glossary and index. Published by NCCHC. Soft cover. $69.95 CCHP Items A s the Cer tif ied Correctional Health Professional program celebrates its 20th year, be sure to stock up on these professional items adorned with the CCHP logo. Find product descriptions and order online via the publications catalog at ncchc.org. • CCHP Pin Enhancer to mark 5, 10, 15 or 20 years of participation in the program. $10 • CCHP Business Card Case, a stylish way to tote your business cards. $8 • CCHP Cup and Coaster, 11 oz. white porcelain cup with coaster that can serve as a lid to keep beverages warm. $7.50 for one, $6 for two • CCHP Executive Organizer with mini binder, calendar, address book and more. $20 (2012 refills: $9) About CorrectCare™ CorrectCare is the quarterly magazine of the National Commission on Correctional Health Care. Its mission is to publish news, articles and commentary of relevance to professionals in the field of correctional health care. Subscriptions: CorrectCare is mailed free of charge to members of the Academy of Correc tional Health Professionals, key personnel at accredited facilities and other recipients at our discretion. To see if you qualify for a subscription, submit a request online at ncchc.org or by e-mail to info@ncchc.org. The magazine is also posted at ncchc.org. 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. See page 1 for contact information. Editorial Submissions: Submitted articles may be published at our discretion. Manuscripts must be original and unpublished elsewhere. For guidelines, contact Jaime Shimkus at editor@ncchc.org or 773-880-1460. We also invite letters or correction of facts, which will be printed as space allows. Advertiser Index SIMPLIFIND Tap into the incredible network of the National Comission on Correctional Health Care with the NCCHC Buyers Guide. Powered by MultiView, the Guide is the premier search tool for correctional healthcare practitioners. Find the suppliers and services you need, within the network of the association you trust. Simplifind your search today at www.ncchc.org. American Board of Addiction Medicine............................ 36 Atripla (Gilead Sciences) ..........................................................20-23 CCHP-RN Specialty Certification................................................ 19 Complera (Gilead Sciences)......................................................... 5-7 Corizon......................................................................................................10-11 Correct Care Solutions........................................................................ 27 CorrecTek........................................................................................................... 4 Correctional Health Partners......................................................... 28 Correctional Medical Associates............................................... 17 GEO Group................................................................................................... 33 InFocus Lists.................................................................................................. 34 Journal of Correctional Health Care......................................... 26 Medi-Dose..................................................................................................... 29 MHM Services...........................................................................................BC NCCHC Accreditation........................................................................ 14 NSU Healthcare......................................................................................... 30 Reyataz (Bristol-Myers Squibb) .................................................. 15 Spectra Diagnostics..............................................................................IBC Sustiva (Bristol-Myers Squibb) .................................................... 31 Wexford Health Sources.................................................................... 25 Updates in Correctional Health Care.....................................IFC 35 www.ncchc.org Fall 2011 • CorrectCare Standards Q & A Expert Advice on NCCHC Standards by Jennifer E. Snow, MPH, CCHP, and Scott Chavez, PhD, MPA, CCHP-A Defining ‘Isolation’ in Suicide Prevention Q There has been some debate as to the interpretation of the Suicide Prevention Program standard (Y-G05) in the new 2011 Standards for Health Services in Juvenile Detention and Confinement Facilities. Compliance indicator #1d states: “Potentially suicidal juveniles are monitored on an irregular schedule with no more than 15 minutes between two checks. If, however, the potentially suicidal juvenile is placed in isolation, constant observation is required.” Our debate comes in understanding what is meant by “isolation.” Is it used to refer to those youth on suicide precautions in a room by himself/herself or does it refer to more of a punitive status, as in the youth was placed in isolation for behavioral issues in addition to suicide precautions? I contend that it is the former and the latter is generally referred to as “segregation” rather than “isolation.” Another option is that both interpretations are incorrect. Either way, we want to ensure that we have the correct interpretation. A This is a great question. You are correct that the standard is referring to the first interpretation of isolation. When a youth is placed on suicide precautions in a room alone, then constant observation should be conducted. Opioid Treatment Programs Q We are thinking about starting a methadone program in our jail, but we don’t know where to begin. What advice can you give us? A If you are considering an opioid treatment program using methadone, by federal law, OTPs based in correctional facilities must obtain certification from the Substance Abuse and Mental Health Services Administration. To become certified, the OTP first must be accredited by a federally approved body—which NCCHC is, and we offer OTP accreditation. The NCCHC Standards for Opioid Treatment Programs in Correctional Facilities are based on federal regulations but address the special nature of care provided in correctional facilities as well as the necessarily limited focus of such treatment in this setting. For more information, including how to obtain the Standards, visit our website: ncchc.org/accred/OTP.html. Inmate Orientation Information in Spanish Q I am helping a jail get ready for its accreditation survey. I am told that there is not really a Spanish-speaking population in this community. In that case, do they still need to have the inmate orientation information in Spanish as well as English? A Standard J-E-01 Information on Health Services does not state that inmate orientation information must be written in Spanish. The third compliance indicator says, “Special procedures ensure that inmates who have difficulty communicating (e.g., foreign speaking, developmentally disabled, illiterate, mentally ill, deaf) understand how to access health services.” Therefore, if there isn’t a community need to pre-print information in Spanish (or other foreign language), at least there should be a procedure in place so that appropriate efforts are made to ensure that inmates understand how they can access health services. For example, a language line or local translator might be available in the event a Spanish-speaking inmate arrives. Keep in mind that if the bulk of your population speaks only Swahili, then you should accommodate these inmates. Transfer Screening Time Frame Q Standard E-03 Transfer Screening says that “qualified health care professionals review each transferred inmate’s health record or summary within 12 hours of arrival.” Does it mean within 12 hours after the inmate arrives at the new jail and is in housing? Or does it mean within 12 hours of the chart’s arrival at the new jail? A The standard intends that within 12 hours of the inmate’s arrival at the facility (emphasis added), a qualified health care professional should be reviewing the health record or summary to ensure continuity of care. Jennifer E. Snow, MPH, CCHP, is NCCHC’s director of accreditation. Scott Chavez, PhD, MPA, CCHP-A, is NCCHC’s vice president and liaison to the policy and standards committee. Send your question to accreditation@ncchc.org. 36 Fall 2011 • CorrectCare www.ncchc.org personal attention every customer, every sample, every day At Spectra Diagnostics, we realize you deserve more than just test results from your clinical laboratory partner. That’s why we provide the focused, personalized support and flexibility you need to get the job done. Count on Spectra Diagnostics for: • Customer Liaison assigned to each facility for personalized, single-source support • Reliable results and rapid turnaround times • STAT testing services • Extensive courier network • Customized requisitions • Access to results and reports • via custom interfaces Comprehensive training tools For more information, email us at spectra.diagnostics@fmc-na.com or call 888-726-9105 © 2010 Fresenius Medical Care Holdings, Inc. All rights reserved. www.spectradiagnostics.com
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