Defusing a Dangerous Duo

Summer 2008 | Volume 22 | Issue 3 rrectCare™ C The magazine of the National Commission on Correctional Health Care

Nurse Consultants Help Integrate Care How Food Budget Cuts Can Improve Diets

National Commission on Correctional Health Care 1145 W. Diversey Parkway, Chicago, IL 60614 Presented by the National Commission on Correctional Health Care and the Academy of Correctional Health Professionals National Conference on Correctional Health Care October 18–22, 2008 | Chicago, Illinois

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Set to take place in Chicago’s bustling and beautiful downtown, the 2008 National Conference will inspire attendees to elevate their standards of professionalism and health care delivery. Join 2,000 colleagues at this multifaceted forum that offers over 100 concurrent sessions plus many other opportunities to extend your knowledge and your professional network. For more information email [email protected], call 773-880-1460, or visit www.ncchc.org.

Nat Conf CC FP Ad 08.indd 1 4/30/08 4:42:59 PM Summer 2008 | Volume 22 | Issue 3 CorrectCare™ is published quarterly by the National Commission on Correctional Health Care, a not-for-profi t organization whose mission is to improve the quality of health care in our nation’s jails, prisons and juvenile confi nement facilities. ™ NCCHC is supported by 38 leading national organizations representing the fi elds of health, law and corrections. C rrectCare BOARDBOARD OF DIRECTORS RobertRobert E. Morris, MD ((Chair)Chai Society for Adolescent MedicineMedicin Joseph V. Penn, MD, CCHP (Chair-Elect)(Chai American Academy of Child & AdolescentAdolesce Adolescenn Psychiatry George J. Pramstaller, DO, CCHP (Immediate(Immed Past Chair) American OsteopathicOsteopathic AssociationAssociat Thomas J. Fagan,Fagan, PhD (Secretary)(Secre AmericanAmerican PsychologicalPsychological AssociationAssocia Nancy B. White, LPC (Treasurer)(Treasu American CounselingCounseling AssociationAssociat Edward A. Harrison, CCHP (President)(Pres National CommissionCommission on CorrectionalCorrectional HealthH Care Carl C. Bell,Bell, MD,MD, CCHPCCHP NationalNational Medical AssociationAssociatio Patricia Blair, JDJD American Bar Association KleantheKleanthe Caruso, MSN, CCHPCCH AmericanAmerican NursesNurses AssociationAssociation Robert Cohen,Cohen, MDMD AmericanAmerican Public HealthHealth AssociationAssocia Eileen Couture,Couture, DODO American College of Emergency PhysiciansPhy Hon. Richard A. Devine, JD National District Attorneys Association Nina Dozoretz, RHIA, CCHP American Health Information Management Association Charles A. Fasano John Howard Association Kevin Fiscella, MD American Society of Addiction Medicine Robert J. Gogats, MA National Association of County & City Health Offi cials Robert L. Hilton, RPh, CCHP American Pharmacists Association Renee Kanan, MD AmericanA College of Physicians Donald Kern, MD, CCHP AmericanAmeri College of Preventive Medicine JoRene Kerns, BSN, CCHP American CCorrectional Health Services Association Daniel Lorber, MD AAmerican Diabetes Association DDouglas A. Mack, MD, CCHP AAmericanmerican Association of Public Health Physicians NNicholas S. Makrides, DMD 12 American Dental Association EdEdwin I. Megargee, PhD, CCHP AAmericanmerican AssocAssociationi for Correctional and Forensic Psychology CCharlesha A. Meyer, Jr., MD, CCHP-A Features Departments AmeriAmericanc Academy of Psychiatry & the Law EEugene A. Migliaccio, DrPH 7 Spotlight on the Standards: 2 NCCHC News: Education on AmericanAmeric College of Healthcare Executives Ronald C. Moomaw, DO Patient Safety Opioid Treatment in Jails AmericanAmer College of Neuropsychiatrists Peter C. Ober, PA-C 8 Legal Affairs: Jail Escapes 3 Guest Editorial: Warren American Academy of Physician Assistants Peter E. Perroncello, MS Consequences From Tragic Ferguson Calls for Academic- American Jail Association Patricia N. Reams, MD, CCHP Death Corrections Collaboration American Academy of Pediatrics Judith Robbins, LCSW, CCHP 10 National Conference on 4 News Watch National Association of Social Workers Sheriff B.J. Roberts Correctional Health Care National Sheriffs’ Association 6 Journal Preview: Academic David W. Roush, PhD National Juvenile Detention Association 12 Periodontitis and Diabetes: Medicine and Correctional Health Jayne Russell, MEd, CCHP-A Defusing a Dangerous Duo Academy of Correctional Health Professionals Ronald M. Shansky, MD 28 Juvenile Voice: A Bridge to the Society of Correctional Physicians 16 Nurse Consultants Integrate Community for Psychiatric Alvin J. Thompson, MD American Medical Association Medical and Mental Health Care Patients Barbara A. Wakeen, RD in California Prisons American Dietetic Association Henry C. Weinstein, MD 30 CCHP Page: A Day in the Life of a American Psychiatric Association 18 How Food Budget Cuts Can Jail Clinical Social Worker Ronald Wiborg, MBA Improve Diets National Association of Counties 32 Field Notes Copyright 2008 National Commission on Correctional Health Care. Statements of fact and opinion are the responsibility of the authors alone and do not necessarily refl ect the opinions of this publication, NCCHC or its supporting organizations. 34 Classified Ads and Ad Index 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 36 Standards Q&A part provided attribution is given to NCCHC. Send correspondence to editor Jaime Shimkus NCCHC, 1145 W. Diversey Parkway, Chicago, IL 60614 Phone: 773-880-1460; Fax: 773-880-2424 E-mail: [email protected]; Web: www.ncchc.org

Nat Conf CC FP Ad 08.indd 1 4/30/08 4:42:59 PM news New CD Helps Jails Treat Opioid Abusers Nearly every jail in the United States houses individuals Sheriffs’ Association on the NCCHC board. In addition, with substance abuse problems. For many of them, contact NCCHC vice president R. Scott Chavez, PhD, MPA, CCHP-A, with the criminal justice system is the first opportunity for discusses two SAMHSA treatment improvement protocols a substance abuse disorder to be recognized and diagnosed (TIPs) on substance abuse treatment topics. by a medical professional. This presents a unique opportu- We are proud to present this program as one of the nity to begin clinical management and the road to recovery. many means by which NCCHC assists the correctional To help jails identify and provide appropriate health care field. Other assistance we offer includes health MANAGING ADDICTED INMATES: treatment for the substance abusers in their charge, care standards and accreditation, technical assistance, qual- MEDICATION ASSISTED NCCHC has developed an educational CD-ROM and ity reviews, clinical guidelines, professional certification, edu- THERAPY in CORRECTIONS is sending it at no charge to jail administrators nation- cational conferences, publications and more. FEATURE PRESENTATION Managing Addicted Inmates: A multimedia CD-ROM wide. Others may request a complimentary copy via Medication Assisted featuring Virtual Presentations Therapy in Corrections Kevin Fiscella, MD, MPH from national corrections and clinical experts. our Web site, www.ncchc.org. The Importance of Participation, A Sheriff’s Perspective Continuing Education Sherrif B.J. Roberts Produced with support from the Substance Abuse Introduction to TIP 44 and TIP 43 and Mental Health Services Administration, the CD R. Scott Chavez, PhD, CCHP-A Managing Addicted Inmates: contains information that is vital to understanding the Medication Assisted Therapy in Corrections problem and implementing an appropriate response. by Kevin Fiscella, MD, MPH Expertise at Your Fingertips Physicians, nurses, psychologists and CCHPs may earn 1 This invaluable resource features commentary from leading hour of continuing education credit upon viewing this correctional and medical experts, who discuss the devas- program and completing the self-study exam. tating problem of substance abuse and what jails and the medical community are doing to make our communities Learning Objectives safer. The CD also contains downloadable resources. • Define opioid addiction and its signs and symptoms Kevin Fiscella, MD, MPH, explains the importance of • Employ medication assisted therapy to manage medication assisted therapy in outpatient clinics and the addicted inmates steps needed to treat opioid addiction. He provides guid- • Apply principles described in SAMHSA’s TIP 44 for ance on how to comply with federal standards and pro- substance abuse treatment of adults in corrections vide quality care to those addicted to opioids and other substances. Fiscella represents the American Society of Addiction Medicine on NCCHC’s board of directors and is New SAMHSA Grant Supports NCCHC’s an associate professor at the University of Rochester (NY) OTP Accreditation Program School of Medicine. The Substance Abuse and Mental Health Services Admini- Viewers also will meet Sheriff B. J. Roberts, Hampton stration has awarded NCCHC funding related to its accredi- County, VA, who has a deep interest in eradicating drug tation program for opioid treatment programs. The grant is abuse in our nation. Roberts represents the National part of SAMHSA’s effort to reduce the costs of basic accreditation education and accreditation surveys for OTPs. Caaalendarof eeventsvents In this context, accreditation is the peer-review process by which SAMHSA-approved accrediting bodies such as NCCHC make site visits and review the policies, procedures, October 1818-22 22 National Conference on Correctional practices and patient services of an organization providing Health Care, Chicago, IL opioid treatment. The purpose is to ensure that OTPs meet October 19 CCHP examination, Chicago, IL specific, nationally accepted standards for organizational functioning and patient care. November 5 CCHP examination, Hendersonville, NC This latest grant will support quality accreditation ser- November 7 Accreditation committee meeting: Health vices that promote better and more accessible health ser- Services and Opioid Treatment Programs vices for inmates, and that help OTPs to be self-sufficient in February 21 CCHP examination, multiple regional sites maintaining accreditation. A priority is for accredited OTPs to maintain quality of care and to expand their services. April 4-7 Updates in Correctional Health Care, Las An agency of the U.S. Department of Health and Vegas, NV Human Services, SAMHSA is responsible for improving the For a list of regional CCHP exam sites, please visit the accountability, capacity and effectiveness of the nation’s CCHP section at www.ncchc.org. substance abuse prevention, addictions treatment and mental health services delivery systems.

2 Summer 2008 • CorrectCare www.ncchc.org editorial A Call for Academic Collaborations by Warren J. Ferguson, MD develop research networks; create a case for integration of correctional health training into schools of medicine, t’s been more than 30 years since nursing and public health; and further the design for an medical educators in the United Academic Consortium on Correctional Health. IStates and Great Britain wrote of The correctional health field has done a tremendous the need for collaboration between job over these 30 years to develop quality standards and correctional health and academic accreditation, create professional certification programs and medicine. Roll forward and consider share best practices. It is high time now for this excellent that the incarcerated population has progress to receive the legitimacy and support of academic eclipsed 2.3 million, that illnesses such institutions and grant-making organizations to grow the as hepatitis C are of pandemic pro- pipeline of future correctional health clinicians and to portions in corrections facilities and that 95% of inmates, expand and disseminate the body of best evidence sup- many with multiple complex medical and mental health porting best practices. issues, will be released. One might assume that academic medicine has respond- Warren J. Ferguson, MD, is associate professor and vice ed to these challenges. So, what progress has been made in chairman in the department of family medicine and com- linking academe to correctional health? munity health, University of Massachusetts Medical School, Over the last 10 years, there has been slow but steady Worcester. He is co-director of the Third Academic and growth in the number of health professions schools develop- Health Policy Conference on Correctional Health, to be held ing correctional health programs. Public medical schools in in Fort Lauderdale, FL, on Feb. 5-6, 2009. To learn more, visit Georgia, Massachusetts, California and now New Jersey have www.umassmed.edu/commed/ch_conference09. joined the ranks of Texas and Connecticut in contracting with their state prison systems to provide medical and mental health services. At least 30 other academic health science centers are in significant collaborations with jails and prisons. With few exceptions, these collaborations remain largely clinical. NCCHC has also done an excellent job of collaborating NCCHC with representatives from all of the medical and nursing spe- New! cialties concerned with correctional health. Yet, if we step back and evaluate progress through the Standards lens of academe, there is still a lot of work to be done. With the exception of the Journal of Correctional Health Care, Developed by leaders in the fi eld, these there are no peer-reviewed journals that concern them- benchmark standards will help you: selves exclusively with a unique field caring for 2.3 million adults on any given day. With respect to research, apart Q improve health services delivery from the psychiatric field, only a handful of researchers have research portfolios funded by the National Institutes of Q increase organizational effectiveness Health, and these are mostly confined to infectious disease. And despite a unique set of competencies required for Q enhance overall health care for inmates success, clinical training programs focused on correctional health care are few and far between. However, over the last three years, leaders in correctional health affiliated with academic institutions have begun to organize a consortium of academic correctional health. In the spring of 2007 and 2008, the first and second Academic 1145 W. Diversey Parkway, Chicago, IL 60614 and Health Policy Conferences on Correctional Health were phone: (773)880-1460 • fax: (773)880-2424 held in Boston, with an average of 250 participants from 20 email: [email protected] states, 3 provinces of Canada and 25 academic institutions. JCHC‘s October features some of the proceedings of the To order or to see a list of all publications 2007 conference, focusing on blueprints for research and available, visit our Web site at training in correctional health [see page 6]. Preconference meetings at both conferences discussed opportunities to www.ncchc.org.

Standards CC Ad qrtr pgNEW.indd 1 6/10/083 7:56:04 AM www.ncchc.org Summer 2008 • CorrectCare watch

New Combo Drug Therapy Slows COPD proven to be effective. The drug therapy produced similar Patients with moderate to severe chronic obstructive effects regardless of variables such as sex, age, ethnicity and pulmonary disease may benefit from a new drug therapy, body-mass index. “Although treatment did not abolish the according to a study in the American Journal of Respiratory accelerated decline in lung function, it did ameliorate it sub- and Critical Care Medicine. A combination of salmeterol, a stantially,” the authors wrote. beta agonist, and fluticasone propiniate, an inhaled corti- Source: American Thoracic Society, August press releases, cal steroid, proved to reduce the loss of lung function in a www.thoracic.org, and ajrccm.atsjournals.org/cgi/content/ randomized, double-blind, placebo-controlled trial of more abstract/178/4/332 than 6,000 patients in 42 countries. Until now, no drug has been shown conclusively to slow progression of the disease, FDA Lists Drugs Under Review for Safety and smoking cessation has been the only intervention In accordance with the 2007 Food and Drug Administration Amendments Act, the FDA now posts on its Web site a list of drugs being evaluated for potential risks, based on the agency’s review of adverse-event reports submitted by doctors. The list, which is updated quarterly, contains only the drug’s name and the potential problem; it does not reveal the extent of the problem or the number of adverse reports filed, nor does it include all the drugs under FDA review for safety problems. The agency emphasizes that the inclusion of a drug on the list does not mean the medication should not be used. Source: www.fda.gov/cder/aers/potential_signals Number of Youth in Custody Trends Down The number of minors in residential custody in 2006 was 14% lower than in 1999, a year when this population peaked at 107,667, according to a study by the National Council on Crime and Delinquency. A sharper drop, 38%, was seen in the number of youth housed in adult in jails and prisons (13,652 in 1999). The declines stem, in part, from reductions in juvenile crime and arrests, especially for serious offenses related to person or property. However, a New York Times editorial notes that many youth are being confined for minor offenses, and that states seem to be holding in juvenile facilities many youth “who should instead be treated in therapeutic programs near their homes.” Sources: The Declining Number of Youth in Custody in the Juvenile Justice System, 8/2008, www.nccd-crc.org, and Some Progress on Kids and Jails, 8/19/08, www.nytimes.com Public Health Emergencies Legal Preparedness The CDC’s Public Health Law Program has developed a Web-based repository of resources for professionals and policy makers to use in strengthening their agencies’ and jurisdictions’ legal preparedness for all-hazards public health emergencies. The documents and educational courses address a broad range of topics, such as relevant public health laws, the national action agenda, forensic epidemiol- ogy, coordination of response measures, mutual aid agree- ments and more. They were developed with help from practitioners in public health, emergency management, law, law enforcement, the judiciary and corrections to ensure that they speak to the priorities and needs of those with front- line responsibility for dealing with these threats. Source: www2.cdc.gov/phlp/lawmat.asp

4 Summer 2008 • CorrectCare www.ncchc.org STAND UP & STOP THE SPREAD OF HIV “JOIN ME IN THE FIGHT TO END HIV/AIDS IN OUR COMMUNITIES.” EARVIN “MAGIC” JOHNSON

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What happens when dozens of leading lights in academic historically uncommon…. Increasingly, however, the aca- medicine, correctional health, public health and policy get demic and correctional health care communities are view- together? For one, a whole lot of great ideas are generated. ing potential collaborations as not only mutually beneficial, That was a key objective of the first Academic and Health but essential. Significant hurdles still remain, but they no Policy Conference on Correctional Health, hosted by the longer seem insurmountable or justifiable.” University of Massachusetts Medical School in March 2007. The articles note the difficulty in prioritizing investigation The overarching purpose of the two-day meeting was of largely unstudied, yet highly prevalent, health conditions to link academic researchers with correctional health care of national importance, Kendig observes. Yet they succeed administrators and clinicians, as well as the broader public in cataloging a broad range of specific topics for future health community, to develop an academic consortium on research and for health professions education. “Ultimately,” correctional health. UMass Correctional Health, a program he writes, “the ideal research initiatives are those that are of UMass Medical School, convened several work groups to of intriguing interest to researchers, offer the promise to discuss the status quo in correctional health care research, improve patient care and public health, hold the poten- to identify barriers and gaps, and to propose research and tial to enhance the safety of U.S. jails and prisons, and are education agendas to address those gaps. deemed relevant to private and public funding authorities.” The October issue of the Journal of Correctional Health [See the Guest Editorial, page 3, for more on this topic.] Care features a special section with three articles that summarize the findings of the work groups on infectious disease, mental illness and primary care. In the introduction to the section, Rear Adm. Newton E. Kendig, MD, assis- JCHC Volume 14, Issue 4 tant director of the Health Services Division of the Federal Bureau of Prisons and a commissioned officer of the Public Expanded Focus Section Health Service, writes that “Fruitful collaborations between Correctional Health Care and Academic Medicine: academic medicine and correctional health care systems are Bridging the Gap — Introduction by Newton Kendig, MD • Infectious Disease in Correctional Health Care: Pursuing a Research Agenda — David Paar, MD, Carol Bova, PhD, Correctional Pharmacy Excellence … It’s Yours with Maxor RN, Jacques Baillargeon, PhD, William Mazur, MD, and Larry Boly, MD • Correctional Mental Health Research: Opportunities and Barriers — Kenneth L. Appelbaum, MD • Correctional Health Primary Care: Research and Educational Opportunities — Janet Fraser Hale, PhD, APRN, FNP, Arthur M. Brewer, MD, CCHP, and Warren Ferguson, MD

Improving Knowledge, Attitudes, and Testing for Communicable Diseases Among New York State Inmates — Douglas G. Fish, MD, et al.

Shift Work and Correctional Officers: Effects and Strategies for Adjustment — David X. Swenson, PhD, LP, Daniel Waseleski, MA, and Robert Hartl, MA !$6!.#%$4%#(./,/'9s/5434!.$).'3%26)#%s#,).)#!,%80%24)3% Compliance Profile of Depakote ER Compared to Depakote DR and Valproic Acid in Bipolar Patients — Paul J. Morris, RN, CCHP

Each issue of the Journal also has a self-study exam by which physicians, nurses, psychologists and CCHPs may earn continuing education credit. For information about subscriptions or how to submit an article, contact Sage Publications: 800-818-7243, ext. -ARY,INDSAY0OLK$RIVE 3UITEs&RANKLIN 4. 7100; [email protected]; http://jchc.sagepub.com. s&AX sWWWMAXORCOM

6 Summer 2008 • CorrectCare www.ncchc.org on the standards

by RR. Scott Chavez, Chavez PhDPhD, MPAMPA, CCHP-ACCHP-A, and repreport errors or problems that compromise safety. To Jennifer E. Kistler, MPH achieve this culture, it is vital that there be no stigmatiza- tion or punitive action toward those who report errors. decade ago, the Institute of Medicine launched a Patient safety training should occur in staff orientation, quality initiative that placed the issues of patient in-services and self-assessment courses, and be incorpo- Asafety and quality of care at the forefront of health rated into policies and procedures. Policy and procedure care reform. Today, public and private health care systems should dictate exactly what to do in an adverse clinical alike apply a variety of techniques aimed at ensuring patient event or near-miss situation. Protocol might address what safety. forms to fill out, who should receive them, corrective steps In the correctional health care field, NCCHC is a strong for different types of errors and other measures. B-02 Patient Safety advocate for patient safety and has incorporated require- (important) ments for safeguards to prevent adverse and near-miss clini- Task-Oriented Issues The responsible health cal events in its 2008 Standards for Health Services for jails Health system experts are interested in learning how authority promotes and prisons. distractions and interruptions in clinical workflow might The IOM defines safety as freedom from accidental jeopardize patient safety. A study published last year found patient safety by insti- injury. In health care settings, the goal of patient safety 75 distracting events in 406 minutes of observing clinical tuting systems to pre- is pursued through appropriate efforts to avoid adverse tasks. These distractions led to 32 interruptions in care; of vent adverse and near- events related to errors in diagnosis, medication or treat- these, 5 tasks were not completed and 4 were not even miss clinical events. ment. But errors that do not result in patient harm are also remembered by the clinicians. Distractions could result in —2008 Standards for to be avoided. An adverse clinical event would occur from record-keeping mistakes, impede clinician communication switching two look-alike medications (such as Prozac and and endanger patients. Health Services for jails Doxipen) and giving the wrong one to a patient. A near- Consider the pill line nurse under intense pressure to get and prisons miss would be dispensing the wrong medication but not the inmates completed before a scheduled and mandatory actually administering it. roll call. Or simply an environment with slamming steel Patient safety systems use redundancy (double checking) doors, poorly illuminated examination rooms or unavailable procedures to minimize errors and prevent adverse and health records at clinic appointments. What are the chanc- near-miss clinical events. However, redundancy and back- es of human error occurring under these conditions? up procedures alone do not guarantee that patient mor- Patient safety concerns are not limited to medication bidity and mortality will be reduced. In fact, patient safety administration or medical records. Distracted health staff literature now identifies the human factor as an essential may be a root cause of patient falls, hurried staff might skip element in outcomes. The human factor includes personal hand hygiene or an overworked clinician might forget to issues, task-oriented issues and interactions among staff. follow up on an MRI scan. Most literature on patient safety calls for cultural changes in To minimize risk to the patient, administrators should health care systems to minimize the human factor. strive to ensure that health care services are structured— and conducted—with patient safety as a goal. Personal Issues Those who lack the knowledge, skill or motivation to Professional Interactions improve patient safety are often part of the problem. In correctional facilities, health staff must contend with Unfortunately, some health professionals do not fully appre- disruptive behavior from inmates and even from other staff ciate these risks and take a cavalier attitude toward patient members. Such behaviors can lead to preventable adverse safety. Others do care but, due to poor understanding or events and compromise safety and quality. In a recent study perhaps a heavy workload, skip the steps designed to pre- of 4,530 administrators, nurses, doctors and other health vent errors. In correctional facilities, as in the world outside, professionals at 102 veterans’ hospitals, 77% of the respon- it is too easy to become complacent about the status quo, dents reported having witnessed disruptive behavior by even when safeguards are lacking. physicians and 65% by nurses, behaviors that were linked Changes in attitude come when there is a top-down with medical errors and patient mortality. endorsement for a culture of patient safety. Administrators More fundamentally, clear communication among staff should employ strategies to help health care professionals is essential to health care delivery. When communication maintain their interest in quality and safety. Training ses- is disrupted or is unclear, safety suffers. Efforts to improve sions and staff meetings provide good opportunities to communication and minimize disruptive behavior through- build this culture. out the facility can improve staff safety and patient safety. Staff meetings should always reinforce the message that Again, this should become part of the culture and rein- patient safety matters, that attentiveness to what is being forced through recognition and awareness, policies and done (or not done) is an important aspect of the job. Staff must be strongly encouraged to speak up and promptly continued on page 33

7 www.ncchc.org Summer 2008 • CorrectCare affairs Jail Escapes Consequences From Tragic Death

by Fred Cohen, LLM tant. He was never seen over a 10-day period by a physician. A physician’s standing order for the administration of oyett v. County of Washington (2008, not otherwise Thorazine (injected three times) was relied upon. Would a published) is an extremely troubling case. Boyett physician’s examination of Boyett have disclosed the heart died in the Washington County, UT, Purgatory Th at which is B disease and led to responsive care? Correctional Facility under darkly suspicious circumstances, Even if we speculate yes, this panel found that, at worst, done in silence and yet this panel of the 10th Circuit upheld the grant of this was negligence but not the requisite deliberate indiffer- summary judgment to the crowd of individual defendants ence. The panel repeatedly stated that there is no require- and in the dark even though, in my view, the law on point is perfectly clear. ment that a jail provide inmates with around-the-clock The nagging problems, as is often the case, relate primarily access to a medical doctor. However, Boyett was in custody cannot be undone to the facts. for some 10 days and suffered from a variety of obvious One of the more interesting legal question is whether mental and physical problems. “Around-the-clock access” nor the lethal dubious care for Boyett’s mental illness can somehow be simply misstates the problem, which, more accurately, is related to the cause of death, which the medical examiner access to a physician when the gravity of the decedent’s hand exposed. found to be occlusive coronary artery disease with cirrhosis medical condition became clear. That, indeed, was well a contributory cause. There is a debate, which the plain- before the time of his death. tiffs lost, on the cause of death, so my statement on cause should be viewed as somewhat conditional but certainly of Experts Banished academic interest. But there is more. The district court excluded as speculative Another issue relates to the fact that, as I read the record, the proffered testimony of the plaintiff’s three expert wit- Boyett was seen by several nurses and a physician’s assis- nesses. When the expert testimony was excluded, the court determined there was no link between the jail guards—and Purgatory begins to sound like the right name—and the death. Let me reproduce the reviewing court’s description THE MENTALLY of this matter: Plaintiffs’ theory is that Boyett’s rib, rectum, and DISORDERED INMATE head injuries were not self-inflicted. They posit Officer Kounalis and perhaps another officer assaulted Boyett sometime between 5:00 p.m. on September 5 and his AND THE LAW death the next morning. No direct evidence supports this theory; it rest entirely on (1) an expert report Second Edition NEW EDITION! theorizing the injuries could not be self-inflicted, and By Fred Cohen, LL.B., LL.M. Available (2) circumstantial inferences one of the prison guards Now! must have been alone with Boyett and beat him while no one else was looking. We agree with the district “… should be in every correctional court the record does not support Plaintiffs’ theory. institution’s mental health One of the proffered medical experts, Dr. Lara, stat- staff library” ed Boyett died as a result of: (1) trauma received prior — Jeffrey L. Metzner, M.D., Clinical Professor to his death, (2) oversedation from major tranquilizers of Psychiatry, University of Colorado Health Sciences Center of a patient with compromised liver functions, and (3) denial of basic emergency care. Dr. Lara posited Boyett was suffering from liver failure, traumatic injuries (i.e., “Without the rigorous research and chest trauma, rectal tear, and internal bleeding), and brilliant legal analysis Fred Cohen probable overwhelming sepsis. Dr. Lara also stated provides in this marvelous book, videos taken of Boyett before his death showed he was legal advocates and experts would able to lift his arms and move about in a manner that © 2008 1,114 pp. Two volumes be totally out of their element.” would have been impossible had Boyett been suffering ISBN: 1-887554-59-9 from the injuries discovered at his death. —Terry A. Kupers, M.D., M.S.P. US $237.50 Another medical expert, Dr. Lovell, opined Boyett’s injuries were more likely caused by the guards than by (609) 683-4450 Fax (609) 683-7291 www.civicresearchinstitute.com/mdi.html continued on page 24

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5 Dispense medication into Twist TampAlerT cap onto A secure, tamper-evident seal TampAlerT bottle. bottle. 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 6 INC. 215-396-8600, Fax: 215-396-6662 EPS , www.medidose.com Responding to pharmacy packaging needs E-mail: [email protected] around the world Make No Little Plans National Conference on Chicago is a city that inspires. Set to take Correctional Health Care place amid the skyscrapers of its bustling and beautiful downtown, the 2008 Chicago, Illinois National Conference will inspire attendees to elevate their standards of profes- October 18-22, 2008 sionalism and health care delivery.

Benefits of Attending Educational Objectives This multifaceted forum attracts a diverse group of correctional health prac- As part of its mission to provide continuing education, titioners and administrators from all disciplines. The meeting is unparalleled NCCHC specifies learning objectives for each conference. in the quality of professional education it provides. Through lectures, panels, • Demonstrate an understanding of correctional health workshops, posters and exhibits, you will receive the latest information on care issues, including quality of care, access to care, core competencies, best practices and emerging developments. You also will financial management and workforce development gain new allies in the quest for improvement. • Discover the latest tools, techniques and solutions from top professionals • Identify major health care, research and policy issues • Learn how other organizations have implemented successful programs facing incarcerated individuals, including infectious • Deepen your knowledge by attending preconference seminars diseases, mental illness, substance abuse and special • Gain insights from eminent dignitaries during keynote presentations needs (e.g., women’s issues, juvenile health, geriatrics, • Earn continuing education credit in your discipline disability) • Network with colleagues, from top decision makers to in-the-trenches staff • Demonstrate increased understanding of skills neces- • View new products and services in the Exhibit Hall sary to better manage common medical, dental and • Stock up on valuable resources at the NCCHC Bookstore, psychological problems found in correctional settings • Explore Chicago through cultural tours and activities • Describe legal, ethical and administrative issues and Advance Your Knowledge develop solutions for the correctional setting With more than 100 content-rich educational sessions,this meeting offers something for every level of experience. Sessions are designated as basic, Preconference Seminars intermediate or advanced. Here are some of the advanced sessions: Start off right by attending a seminar over the week- • Addressing Adolescent Health Care Needs: From ADHD to Zits end. Presented by some of the most respected names • Correctional Health Care Staffing: It’s Not an Art, It’s a Science in this field, the seminars provide an in-depth look at • Seven Habits of Highly Effective Leaders fundamental elements of delivering quality health care • Spend Money to Save Money? Cost-Effectiveness Analyses in Jails services in correctional settings. Conference registra- • Ten Years of 7th Circuit Federal Court Decisions on Correctional Litigation tion is not required to attend. Fees are $170 for full-day Leadership Series seminars and $95 for half-day seminars and include all course materials and refreshment breaks. These interactive, high-level presentations are a hit every year. Designed for managers, both new and experienced, they will help you hone your skills to Saturday, Oct.18 (full day sessions) become a more effective leader. • An In-Depth Look at NCCHC’s 2008 Standards for • Expert faculty with vast experience in and knowledge Health Services (choose Prisons or Jails) • Diverse topics for a well-rounded view of the nuances of leadership • An In-Depth Look at NCCHC’s 2008 Standards for • Practical information to help you become more effective and efficient Mental Health Services in Correctional Facilities Longer Sessions • An In-Depth Look at NCCHC’s 2008 Standards for To provide more in-depth education on selected subjects, four of the con- Health Services in Juvenile Facilities current sessions will run longer than the usual 60 minutes. Sessions II and XI will be 120 minutes, and Sessions IX and X will be 90 minutes. Sunday, Oct. 19 (half day sessions) • Chronic Disease Management Outstanding Networking • Suicide Prevention: Components of an Effective Plan NCCHC conference attendees are the best and brightest in corrections. This • Practical Preparation for Initial NCCHC Accreditation meeting offers myriad opportunities for great networking. Learn how others • Risk Management in the Correctional Environment are handling the problems that you face every day.

Presented by the National Commission on Correctional Health Care. Find the complete schedule and program updates online at www.ncchc.org.

10 Summer 2008 • CorrectCare www.ncchc.org Thanks to Conference Supporters Meeting Venue NCCHC thanks the following organizations for their All educational activities will take place at the Hyatt Regency Hotel in the support of the National Conference. heart of downtown Chicago at 151 E. Wacker Drive, 60601; 312-565-1234. Due to a high number of early registrants, the hotel is sold out on several Sponsor Academy of Correctional Health Professionals nights of the conference. For other hotel options nearby, please contact A Room With a View booking service: 800-780-4343. Mention the NCCHC Cohosts • Cook County Sheriff’s Office conference when making your reservations. • DuPage County Sheriff’s Office • Illinois Department of Corrections • Illinois Sheriffs’ Association Exhibit Hall Activities With more than 125 companies participating, the exhibit hall will be a hot We also thank the many exhibiting companies that spot. This provides a unique opportunity to meet with many of the most provided generous corporate sponsorships in support knowledgeable representatives in our field to learn about the latest products, of conference programming. technologies and services available to aid in delivery of high quality care. Educational Poster Display: Meet one-on-one with the poster authors to Continuing Education discuss their work during the exhibit hall opening reception on Sunday eve- The maximum hours of CE credit in each category ning. Open for viewing throughout the conference during exhibit hall hours, include credits offered at preconference seminars. the posters address a broad range of topics: program innovations, research • CCHPs: Certified Correctional Health Professionals findings, treatment recommendations and more. may earn up to 32 contact hours of Category I con- Exhibit Raffles: Attendees won’t want to miss the raffle drawings on tinuing education for recertification. Tuesday, when they will have the chance to win educational, leisure and • Nurses: NCCHC is an approved provider of nursing monetary gifts. Past prizes have included NCCHC conference registrations, CE by the Illinois Nurses Association, an accredited Academy membership vouchers, golf clubs, DVD players, i-Pods, jewelry, approver by the American Nurses Credentialing American Express gift cards, computers and much more! Center’s Commission on Accreditation. This activity was approved for 32 contact hours. • Physicians: NCCHC is accredited by the Accreditation Registration Information Council for Continuing Medical Education to provide Visit www.ncchc.org for online registration or to download a form, or call continuing medical education for physicians. NCCHC NCCHC headquarters at 773-880-1460 for other options. designates this educational activity for a maximum of • Academy Member: $340. The Academy of Correctional Health 32 AMA PRA Category 1 Credits™. Professionals is a conference sponsor. Members save $75 on the full regis- • Psychologists: NCCHC is approved by the American tration fee. Psychological Association to offer continuing educa- • Nonmember: $415. If you are not a an Academy member and wish to tion for psychologists. This activity is approved for up join, simply sign up using the conference registration form. to 32 hours of credit. See the final program for a list of presentations appropriate for credit for psychologists. • One Day: $195. Select the day you wish to attend. The one-day fee entitles you to participate in all events that day. • Social Workers: This program is approved by the National Association of Social Workers for 32 hours of • Guest Registration: $55. This fee enables guests or spouses of registered continuing education contact hours. attendees to attend all exhibit hall events.

11 www.ncchc.org Summer 2008 • CorrectCare Periodontitis and Diabetes Defusing a Dangerous Duo

by Lori StrunckStrunck, RDHRDH, and Carl BB. AusfahlAusfahl, MSMS, RNRN, CCHP although the reason for these differences is unclearunclear. Furthermore, the costs of treating periodontitis and iabetes mellitus is thought to affect 4.8% of the 2.2 diabetes are staggering. In 2006, researchers evaluated the million inmates in the United States, according to It’s important effects of periodontal disease on the use and cost of medi- Destimates in NCCHC’s 2002 Health Status of Soon- cal and dental health care among 4,285 civil officers aged to-Be-Released Inmates report. Health care professionals that periodontal 40-59. Those with severe periodontitis accrued a 21% higher struggle daily to help these patients control their diabetes. total cost of medical and dental care. Unfortunately, this population tends to have poor compli- assessment and Because periodontal infection may complicate manage- ance with diabetes control regimens, which typically focus ment of diabetes, and because both conditions are so costly therapy be part of on diet, exercise and lifestyle. to treat, it is important to include periodontal assessment But there’s another promising strategy in the fight to and therapy as part of the diabetic treatment plan in cor- the diabetic treat- control diabetes: good oral health. Several recent studies rectional facilities. That’s why the Edna Mahan Correctional have reported an association between diabetic control and Facility for Women, Clinton, NJ, has initiated a performance ment plan. periodontitis. Although a causal relationship has not been improvement program to aggressively treat periodontal dis- proven, it is believed that oral inflammation associated with ease in its diabetic population. periodontitis increases the risk for diabetic complications. (See box on page 13 to learn more about this relationship.) Taking Measure Many inmates possess risk factors associated with The average population at EMCFW is about 1,000 at any periodontitis, including stress and smoking, as well as back- given time. Of these 1,000 women, 80 to 90 have some grounds marked by poverty, poor nutrition and hygiene, form of diabetes mellitus, a rate higher than the NCCHC lack of education, dental phobia and poor dental treat- estimate. Our goal was to monitor and improve the peri- ment. They also are afflicted with diseases predisposing odontal health of the inmates, reduce diabetic complica- them to periodontitis, such as HIV, TB, syphilis, herpes, tions, increase compliance with treatment regimens and cancer and diabetes. In prisons, widespread use of prescrip- improve continuity of care between medical and dental tion medications contributes to xerostomia, or dry mouth, professionals. which also increases the risk. Ethnicity may play a role, as The current standard for periodontal therapy in the New well. It is estimated that periodontal disease affects 35% Jersey Department of Corrections is to offer a complete of Hispanic-Americans and 42% of African-Americans,

12 Summer 2008 • CorrectCare www.ncchc.org dental prophylaxis within 60 days of intake and once every two years thereafter. If periodontitis is diagnosed at the initial visit, the inmate is generally rescheduled for follow-up. Cause and Effect Our performance improvement initiative determined that an aggressive approach for diabetes patients with Although inconclusive thus far, studies continue to periodontitis would involve more frequent recall, monitor- investigate what role periodontitis plays in an indi- ing of infected areas, site-specific periodontal scaling, root vidual’s ability to maintain diabetic control. It is fact, planing and curettage, antibiotic therapy and antimicrobial however, that diabetes increases the risk for periodon- irrigation. tal disease and that periodontal disease initiates the To monitor the periodontal health of these inmates, the body’s inflammatory response. Here’s how these rela- dental hygienist recorded data using five dental indices. The tionships are presently understood. information was documented in the electronic medical Periodontitis is a bacterial infection of the gingiva record of each inmate and on a spreadsheet for quick refer- (gums) and periodontium (the connective tissue ence. The indices are as follows: and bone supporting the teeth). Such infections may • Plaque index (0-3 scale): This measures the level of induce chronic inflammation, which, in turn, may plaque along the gumline or in the gingival pocket (the nat- decrease insulin-mediated glucose uptake, leading to ural space surrounding each tooth). Plaque is an indicator high blood sugar and reducing diabetic control. of bacterial accumulation and a risk factor for periodontal Oral inflammation begins when bacteria accumulate disease. in the mouth and form plaque. These bacteria can • Calculus index (0-2 scale): When plaque calcifies in the release toxins that infiltrate inflamed oral tissue, enter oral cavity, it is known as calculus, or tartar. Subgingival tar- the bloodstream and spread systemically. Circulating tar calcifies below the gumline and poses a greater risk for toxins can stimulate the immune response and trigger inflammation. release of inflammatory markers that are thought to • Debris index (0-3 scale): This records the amount of increase insulin resistance, boosting glucose levels in stain or debris on the tooth surface. Stain accumulation diabetics. aids the build up of plaque and tartar and indicates poor The risk runs both ways: Diabetics with poor control hygiene. of blood sugar get periodontal disease more often • Bleeding index (percentage): Theoretically, healthy gums and more severely than do persons with good control. do not bleed, and bleeding is a major indicator of periodon- Among young adults, those with diabetes have about tal health. This index records the percentage of bleeding twice the risk for periodontal disease compared to points per tooth surface. Generalized bleeding is defined those without diabetes. In one study of 263 diabetics, as affecting 30% or more of tooth surfaces, whereas local- the prevalence in individuals aged 19 to 32 was 39%. ized bleeding affects less than 30%. The goal was to reduce What’s the connection? Insulin is needed to take up gingival bleeding to less than 30%, signifying control of the blood glucose and store it as glycogen in the liver and periodontal infection. muscles. Too much sugar in the blood may increase • Gingival inflammation index (0-3 scale): Gum inflamma- the risk for vascular complications associated with dia- tion is another key indicator of periodontal health. Normal betes, such as thickening of blood vessels. Thickened to mild inflammation was considered controlled and not blood vessels may slow the flow of oxygen and nutri- aggressively monitored. ents to inflamed oral tissue and hinder the removal of harmful wastes, increasing the risk for gum disease. Target Patients Treating periodontitis may lower the rate of vas- After deciding on these oral indices, we consulted the cular complications associated with uncontrolled medical staff to determine the target population among blood glucose. In fact, complete metabolic control of the 81 diabetes patients we had at that time. The medical diabetes may not be possible when periodontal infec- staff actively monitors all diabetes patients for HbA1c level tion is present, according to the National Diabetes (a measure of the glycosylated hemoglobin in the blood). Information Clearinghouse. An HbA1c level close to or within a range of 4% to 5.9% Collaboration between medical and dental profes- indicates good glucose control; levels exceeding 7% indicate sionals will strengthen as research continues to investi- compromised control. When this project began, 31 inmates gate the oral-systemic link. were labeled “uncontrolled,” with HbA1c levels greater than 7%. These inmates became the target population for aggressive treatment of periodontal disease. than 30% of bleeding sites remained. The patients were The women were recalled for periodontal assessment then scheduled for a dental prophylaxis in one year. and therapy as needed. At each visit, oral indices for peri- During this time, the dental hygienist also monitored the odontal disease were documented. Depending on the HbA1c level of these uncontrolled diabetic inmates using degree of infection, the women were rescheduled from the medical record. The HbA1c level was documented two weeks to three months later for aggressive periodontal therapy. The disease was considered localized when less continued on page 14

13 www.ncchc.org Summer 2008 • CorrectCare Diabetes(continued) and Periodontitis (continued from page 13)

before the initial dental prophylaxis, immediately before inmates by dental staff also has improved continuity of the aggressive periodontal treatment intervention and then care. On intake, through collaborative efforts of all health tracked thereafter. The medical staff was supportive of the care professionals, inmates can be educated to help them project and helped by conducting the additional HbA1c understand the relationship between diabetes and perio- testing. dontal disease. Signs and symptoms of periodontal disease can be explained to promote their acceptance of preven- Measurable Improvement tive oral health care. Of the 31 inmates targeted for aggressive periodontal treat- In addition, diabetes patients with uncontrolled blood ment, 22 accepted treatment (the other nine were either glucose levels can be referred for periodontal screening and released, transferred to another prison, refused to partici- follow-up. Active monitoring of HbA1c levels by dental staff pate or had no teeth). The average HbA1c level of the and aggressive periodontal intervention may improve dia- uncontrolled diabetic inmates before aggressive periodontal betic compliance and reduce complications. The benefits treatment was 8.2. After the intervention, the average level add up to much more than just a healthy mouth. was 7.3. Furthermore, the HbA1c level remained the same or decreased in 17 inmates. Of the remaining five inmates, two had a higher HbA1c level, but no data were available Lori Strunck, RDH, is a dental hygienist at at the Edna Mahan for the other three. Correctional Facility for Women in Clinton, NJ. She can be Approximately six months after we started the per- reached by e-mail at [email protected]. formance improvement project, the periodontium of 10 Carl B. Ausfahl, RN, MS, CCHP, is the quality improvement of the 22 diabetic inmates was considered healthy. The director for Correctional Medical Services’ Maryland office; remaining 12 continued to be actively rescheduled for at the time this article was written, he served in the same periodontal treatment, and at this writing, only five of the role in the CMS New Jersey office. inmates still have an HbA1c level above 7%. Thus, good diabetic control has been restored for more than three-fourths of the women in this study. Monitoring and tracking HbA1c levels of diabetic

14 Summer 2008 • CorrectCare www.ncchc.org DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS Efavirenz: Efavirenz has been shown in vivo to induce CYP3A. Other compounds that are substrates of CYP3A may Pregnancy - Pregnancy Category D [see Warnings and Precautions] have decreased plasma concentrations when coadministered with efavirenz. In vitro studies have demonstrated Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers that efavirenz inhibits 2C9, 2C19, and 3A4 isozymes in the range of observed efavirenz plasma concentrations. not breast-feed their infants to avoid risking postnatal transmission of HIV-1. Studies in rats have Coadministration of efavirenz with drugs primarily metabolized by these isozymes may result in altered plasma demonstrated that both efavirenz and tenofovir are secreted in milk. It is not known whether efavirenz, concentrations of the coadministered drug. Therefore, appropriate dose adjustments may be necessary for these emtricitabine, or tenofovir is excreted in human milk. Because of both the potential for HIV-1 transmission and the drugs. Drugs that induce CYP3A activity (eg, phenobarbital, rifampin, rifabutin) would be expected to increase the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they clearance of efavirenz resulting in lowered plasma concentrations. are receiving ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Emtricitabine and Tenofovir DF: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, Pediatric Use: ATRIPLA is not recommended for patients less than 18 years of age because it is a fixed-dose coadministration of ATRIPLA (efavirenz 600 mg /emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) with combination tablet containing a component, tenofovir DF, for which safety and efficacy have not been established drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of in this age group. emtricitabine, tenofovir, and/or other renally eliminated drugs. Some examples include, but are not limited to, Geriatric Use: Clinical studies of efavirenz, emtricitabine, or tenofovir DF did not include sufficient numbers of acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, and valganciclovir. subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose Coadministration of tenofovir DF and didanosine should be undertaken with caution and patients receiving this selection for the elderly patients should be cautious, keeping in mind the greater frequency of decreased hepatic, combination should be monitored closely for didanosine-associated adverse reactions. Didanosine should be renal, or cardiac function, and of concomitant disease or other drug therapy. + discontinued in patients who develop didanosine-associated adverse reactions. Suppression of CD4 cell counts Hepatic Impairment: The pharmacokinetics of efavirenz have not been adequately studied in patients with hepatic has been observed in patients receiving tenofovir DF with didanosine 400 mg daily. Atazanavir and impairment. Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical lopinavir/ritonavir have been shown to increase tenofovir concentrations. ATRIPLA should be discontinued in experience in patients with hepatic impairment, caution should be exercised in administering ATRIPLA to these patients who develop tenofovir-associated adverse reactions. Coadministration of atazanavir with ATRIPLA is not patients [see Warnings and Precautions]. recommended. There are insufficient data to support dosing recommendations for atazanavir, with or without Renal Impairment: Because ATRIPLA is a fixed-dose combination, it should not be prescribed for patients requiring ritonavir in combination with ATRIPLA. dosage adjustment such as those with moderate or severe renal impairment (creatinine clearance <50 mL/min) Efavirenz, Emtricitabine and Tenofovir DF: Other important drug interaction information for ATRIPLA is [see Warnings and Precautions]. summarized below. The drug interactions described are based on studies conducted with efavirenz, emtricitabine OVERDOSAGE 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. 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. Established and Other Potentially Significant Drug Interactions*: Alteration in Dose or Regimen May Be Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz. Hemodialysis can remove Recommended Based on Drug Interaction Studies or Predicted Interaction both emtricitabine and tenofovir DF, but is unlikely to significantly remove efavirenz from the blood. Antiretroviral agents: Protease Inhibitors — Atazanavir: ȇ atazanavir concentration, Ȇ tenofovir Efavirenz - Some patients accidentally taking 600 mg twice daily have reported increased nervous system concentration. Coadministration of atazanavir with ATRIPLA is not recommended. Coadministration of atazanavir with symptoms. One patient experienced involuntary muscle contractions. 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 Emtricitabine - Limited clinical experience is available at doses higher than the therapeutic dose. In one study single tenofovir concentrations. There are insufficient data to support dosing recommendations for atazanavir or doses of emtricitabine 1200 mg were administered to 11 patients. No severe adverse reactions were reported. atazanavir/ritonavir in combination with ATRIPLA. Fosamprenavir calcium:ȇamprenavir concentration. Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting Fosamprenavir (unboosted): Appropriate doses of fosamprenavir and ATRIPLA with respect to safety and efficacy within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). have not been established. Fosamprenavir/ritonavir: An additional 100 mg/day (300 mg total) of ritonavir is It is not known whether emtricitabine can be removed by peritoneal dialysis. recommended when ATRIPLA is administered with fosamprenavir/ritonavir once daily. No change in the ritonavir dose Tenofovir DF - Limited clinical experience at doses higher than the therapeutic dose of tenofovir DF 300 mg is is required when ATRIPLA is administered with fosamprenavir plus ritonavir twice daily. Indinavir:ȇindinavir available. In one study, 600 mg tenofovir DF was administered to 8 patients orally for 28 days, and no severe concentration. The optimal dose of indinavir, when given in combination with efavirenz, is not known. Increasing adverse reactions were reported. The effects of higher doses are not known. the indinavir dose to 1000 mg every 8 hours does not compensate for the increased indinavir metabolism due to Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a efavirenz. Lopinavir/ritonavir:ȇlopinavir concentration,Ȇtenofovir concentration. A dose increase of single 300 mg dose of tenofovir DF, a 4-hour hemodialysis session removed approximately 10% of the dose. lopinavir/ritonavir to 600/150 mg (3 tablets) twice daily may be considered when used in combination with PATIENT COUNSELING INFORMATION efavirenz in treatment-experienced patients where decreased susceptibility to lopinavir is clinically suspected (by See FDA-Approved Patient Labeling (17.12) in Full Prescribing Information 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 Drug Interactions: A statement to patients and healthcare providers is included on the product’s bottle labels: reactions. Ritonavir:Ȇritonavir concentration,Ȇefavirenz concentration.When ritonavir 500 mg every 12 hours was ALERT: Find out about medicines that should NOT be taken with ATRIPLA. coadministered with efavirenz 600 mg once daily, the combination was associated with a higher frequency of ATRIPLA may interact with some drugs; therefore, patients should be advised to report to their doctor the use of any adverse clinical experiences (eg, dizziness, nausea, paresthesia) and laboratory abnormalitiesFull (elevated pageliver other prescription, Ad nonprescription medication, or herbal products, particularly St. John’s wort. enzymes). Monitoring of liver enzymes is recommended when ATRIPLA is used in combination with ritonavir. Information for Patients: Patients should be advised that ATRIPLA is not a cure for HIV-1 infection and patients Saquinavir:ȇsaquinavir concentration. Should not be used as sole protease inhibitor in combination with ATRIPLA. may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients NRTI — Didanosine:Ȇdidanosine concentration. Higher didanosine concentrations could potentiate didanosine- should remain under the care of a physician when using ATRIPLA; the use of ATRIPLA has not been shown to reduce associated adverse reactions, including pancreatitis, and neuropathy. In adults weighing >60 kg, the didanosine the risk of transmission of HIV-1 to others through sexual contact or blood contamination; the long-term effects of dose should be reduced to 250 mg if coadministered with ATRIPLA. Data are not available to8” recommend x 10a ATRIPLA 1/2” are unknown; redistribution or accumulation of body fat may occur in patients receiving antiretroviral dose adjustment of didanosine for patients weighing <60 kg. Coadministration of ATRIPLA and didanosine therapy and that the cause and long-term health effects of these conditions are not known; ATRIPLA should not be should be undertaken with caution and patients receiving this combination should be monitored closely coadministered with SUSTIVA, EMTRIVA, VIREAD, or TRUVADA, or drugs containing lamivudine, including Combivir, for didanosine-associated adverse reactions. For additional information, please consult the Videx/Videx EC Epivir, Epivir-HBV, Epzicom, or Trizivir. (didanosine) prescribing information. Patients should be advised that: Other Agents: Anticoagulant — Warfarin:Ȇorȇwarfarin concentration. Plasma concentrations andPage effects • lactic 15 acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with potentially increased or decreased by efavirenz. ATRIPLA will be suspended in any patients who develop clinical symptoms suggestive of lactic acidosis or Anticonvulsants — Carbamazepine:ȇcarbamazepine concentration,ȇefavirenz concentration. There are pronounced hepatotoxicity [see Warnings and Precautions]. insufficient data to make a dose recommendation for ATRIPLA. Alternative anticonvulsant treatment should be used. • they may be tested for hepatitis B virus (HBV) before initiating antiretroviral therapy. Severe acute exacerbations Phenytoin, Phenobarbital:ȇanticonvulsant concentration,ȇefavirenz concentration. Potential for reduction in of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued anticonvulsant and/or efavirenz plasma levels; periodic monitoring of anticonvulsant plasma levels should be EMTRIVA or VIREAD, which are the components of ATRIPLA. conducted. • renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported. ATRIPLA Antidepressant — Sertraline:ȇsertraline concentration. Increases in sertraline dose should be guided by clinical should be avoided with concurrent or recent use of a nephrotoxic agent [see Warnings and Precautions]. response. • decreases in BMD have been observed with the use of tenofovir DF; BMD monitoring may be performed in Antifungals — Itraconazole:ȇitraconazole and hydroxy-itraconazole concentration. Since no dose recommendation patients who have a history of pathologic bone fracture or at risk for osteopenia [see Warnings and Precautions]. for itraconazole can be made, alternative antifungal treatment should be considered. Ketoconazole:ȇketoconazole • take ATRIPLA orally on an empty stomach and that it is important to take ATRIPLA on a regular dosing schedule concentration. Drug interaction studies with ATRIPLA and ketoconazole have not been conducted. Efavirenz has the to avoid missing doses. potential to decrease plasma concentrations of ketoconazole. Nervous System Symptoms: Patients should be informed that central nervous system symptoms (NSS) are commonly Anti-infective — Clarithromycin:ȇclarithromycin concentration,Ȇ14-OH metabolite concentration. Clinical reported during the first weeks of therapy with efavirenz. Dosing at bedtime may improve the tolerability of these significance unknown. In uninfected volunteers, 46% developed rash while receiving efavirenz and clarithromycin. symptoms, which are likely to improve with continued therapy. Patients should be alerted to the potential for additive No dose adjustment of ATRIPLA is recommended when given with clarithromycin.Alternatives to clarithromycin, such effects when ATRIPLA is used concomitantly with alcohol or psychoactive drugs. Patients should be instructed that if as azithromycin, should be considered. Other macrolide antibiotics, such as erythromycin, have not been studied in they experience NSS they should avoid potentially hazardous tasks such as driving or operating machinery [see combination with ATRIPLA. Warnings and Precautions and Dosage and Administration (2) in Full Prescribing Information]. Antimycobacterials — Rifabutin:ȇrifabutin concentration. Increase daily dose of rifabutin by 50%. Consider Psychiatric Symptoms: Patients should be informed that serious psychiatric symptoms have been reported in doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week. Rifampin:ȇefavirenz patients receiving efavirenz. If they experience severe psychiatric adverse experiences they should seek immediate concentration. Clinical significance of reduced efavirenz concentration is unknown. Dosing recommendations for medical evaluation. Patients should be advised to inform their physician of any history of mental illness or substance concomitant use of ATRIPLA and rifampin have not been established. abuse [see Warnings and Precautions]. Calcium channel blockers — Diltiazem: ȇdiltiazem, desacetyl diltiazem, and N-monodesmethyl diltiazem Rash: Patients should be informed that a common side effect is rash. Rashes usually go away without any change concentrations. Diltiazem dose adjustments should be guided by clinical response (refer to the complete in treatment. However, since rash may be serious, patients should be advised to contact their physician promptly if prescribing information for diltiazem). No dose adjustment of ATRIPLA is necessary when administered with rash occurs. diltiazem. Others (eg, felodipine, nicardipine, nifedipine, verapamil): ȇcalcium channel blocker. No data are available Reproductive Risk Potential: Women receiving ATRIPLA should be instructed to avoid pregnancy [see Warnings on the potential interactions of efavirenz with other calcium channel blockers that are substrates of the CYP3A4 and Precautions]. A reliable form of barrier contraception should always be used in combination with other methods enzyme. The potential exists for reduction in plasma concentrations of the calcium channel blocker. Dose of contraception, including oral or other hormonal contraception. Women should be advised to notify their physician adjustments should be guided by clinical response (refer to the complete prescribing information for the calcium if they become pregnant or plan to become pregnant while taking ATRIPLA. If this drug is used during the first channel blocker). trimester of pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the HMG-CoA reductase inhibitors — Atorvastatin:ȇatorvastatin concentration, Pravastatin:ȇpravastatin potential harm to the fetus. concentration, Simvastatin:ȇsimvastatin concentration. Plasma concentrations of atorvastatin, pravastatin, and simvastatin decreased with efavirenz. Consult the complete prescribing information for the HMG-CoA reductase inhibitor for guidance on individualizing the dose. Narcotic analgesic — Methadone:ȇmethadone 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 Bristol-Myers Squibb & Gilead Sciences, LLC. Foster City, CA 94404 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 ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc. symptoms. SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. REYATAZ and VIDEX are registered trademarks of Ȇ Bristol-Myers Squibb Company. Pravachol is a registered trademark of ER Squibb & Sons, LLC. Other brands listed are the Oral contraceptive — Ethinyl estradiol: ethinyl estradiol concentration. Clinical significance unknown. Because trademarks of their respective owners. the potential interaction of efavirenz with oral contraceptives has not been fully characterized, a reliable method of barrier contraception should be used in addition to oral contraceptives. © 2008 Bristol-Myers Squibb & Gilead Sciences, LLC. Based on: 21-937-GS-004 *Please see Full Prescribing Information (Table 4) for additional information; this list is not all inclusive. ST0058 SF-B0001A-06-08 697US08PBS00201 June 2008 Nurse Consultants Integrate Medical and Mental Health Care in California Prisons

by Deborah Lucas, RNC, MSN, CCHP sprawling land surrounding multitudes of buildings make it difficult to communicate with nurses in another yard, let ursing organizations in the hospital field talk openly alone those in another discipline or department such as and proudly about their multidisciplinary approach mental health. Nto patient care. Many prisons and jails would like In the southern region, the medical and mental health to have the same approach, but environmental issues, NCPRs recognized early on that although there are two short staffing, and sheer patient numbers and acuity tend lawsuits to which those services respond and two different to intensify the divisions. Correctional settings add a third budget processes overseen by the courts and state gov- element—custody—to the equation, which often further ernment, nursing did not have to follow that delineation. divides staff. After all, the patient is still one and the same. Care delivery The California Department of Corrections and is moving forward to a quality model, so why shouldn’t Rehabilitation nurses who provide care to patients in 33 nursing relationships move in that direction as well? Nurses prisons with approximately in the facilities that NCPRs 175,000 inmates endure the visit have many of the same same challenges. And they concerns about the need must do so in the context for integration and col- of two ongoing lawsuits laboration to produce better that guide care provided in patient outcomes. mental health and medical This group of NCPRs and services. their regional director of The arrival of a new nursing quickly realized that court-appointed receiver we wanted to work togeth- who values the integration er, we didn’t want to dupli- of services in a collaborative cate work and we wanted to forum has inspired hope facilitate coordinated care among these nurses. by one discipline—and that However, in the southern each group had informa- region, nurse consultants tion and expertise that could complement the other. Even for program review (NCPRs) for both medical and mental though mental health and medical NCPRs’ goals and direc- health started that integration process long before the new tives were sometimes bipolar and often directed them away receiver stepped in. from physically working with each other, the commitment to collaborate continued. Diverse Challenges During the post-lawsuit era, CDCR management recognized Common Ground the difficulty of uniformly making changes and of commu- Medical NCPRs are greater in number than mental health nicating those changes across the system. In response, the NCPRs and do not report through the same organizational NCPR position was developed to integrate, coordinate and structure, but the contributions of both groups are equally evaluate health care in the system. The NCPRs take a major valuable. For instance, the task of medication management role in bridging the gaps. For instance, the NCPR has the is important to medical and psychiatric patients alike in the opportunity to relate best practices used at one prison to prison, and it was a common starting ground for communi- others and to assure their implementation. cation between NCPRs. The CDCR employs both medical and mental health At the outset, the regional DON introduced the mental nurse consultants and assigns each to a specific region. health NCPRs to the various on-site directors of nursing Working as a nurse consultant in this system presents many as a person with whom the local staff should work, which diverse challenges that virtually assure job satisfaction. The sends the message that the mental health NCPR is a person NCPRs contact all prisons in their region and assist the of value and knowledge. It clears the way for contacts and health care staff in meeting the needs of their patients and communication. facility. Troubleshooting, helping the staff to bridge gaps Now, the mental health NCPRs make a point to check with custody, conducting and reviewing audits, and partici- in with the director of nursing at each visit and to inform pating with the staff in meetings, staff interviews, quality the DON of their task for the day. When the regional DON management, utilization review and educational seminars holds monthly staff meetings, the mental health nurses are are just some of the duties assigned to NCPRs. always invited and they do attend. Projects, common issues But although they share many of the same duties, the and resolutions are routinely discussed at those meetings. NCPRs in the two programs were not unified. The mere Information about changes in management, regional staff size of each prison, number of potential patients and and local facility staff are also shared with each other.

16 Summer 2008 • CorrectCare www.ncchc.org (continued)

Whenever possible the NCPRs visit the facilities together. and mental health a role in the solution and in creating a This unity lends credibility to the NCPRs and promotes a shared vision for patient care. sense of teamwork to the nursing and facility management staff. More concretely, NCPRs from medical and mental A Bright Future health use each other’s extensive specialized backgrounds The southern region’s collaborative approach is now being to collaborate on educational in-services and in their con- shared with other regional groups at joint NCPR meetings, tributions to nursing orientations. and these groups are looking forward to even more exciting endeavors in the near future. A new pharmacy system, new Case in Point psychiatric technician job statements and joint educational A mental health NCPR was asked to intervene in a facility endeavors are planned. Joint efforts have produced a new for a situation where registered nurses were being replaced restraint and seclusion policy, identified new and expanded with licensed psychiatric technicians for certain needs that roles for facility nurses and presented an example of a true are usually exclusive to the RN staff. Disagreements about team approach for other prisons and jails to emulate. which discipline was to be responsible for which assign- So while the judges, monitors, special masters, receiver ments escalated into an issue with the RN labor union. and a litany of attorneys meet to decide the integrated fate But the medical and mental health NCPRs jointly attend- of the medical and mental health care at California state ed the next labor-management meeting and together came prisons, the NCPRs vow that they will move forward full up with workable resolutions to which the union agreed steam ahead as a team, no matter what. that pleased nurses, technicians and management. The mental health NCPR had experience writing exam questions for the LVN/LPT state board exams and is highly Deborah Lucas, RNC, MSN, CCHP, was a nursing consul- knowledgeable about their scope of practice. At the meet- tant with the California Department of Corrections and ing, she clarified the LVN/LPT scope of practice for the Rehabilitation, Mental Health Services. She is now chief department and for the union. The two NCPRs convinced nursing officer at Gateways Mental Health Hospital and the union that the LPT could and should complete the Community Mental Health Centers, Los Angeles. She can task under the direction of an RN. This solution not only be reached at [email protected]. adheres to practice guidelines but also gave both medical

17 www.ncchc.org Summer 2008 • CorrectCare Turning Lemons Into (Sugar-Free) Lemonade How Food Budgets Cuts Can Improve Diets

by Barbara Wakeen, MA, RD, LD NYC DOC Commissioner Martin Horn credits Johnson with bringing better nutrition and healthy diets to the city’s aintaining good nutrition in correctional food jails. “[Johnson] recognized a decade ago that many of our service is a continual challenge as budgets grow inmates come into custody with poor health and unhealthy Mtighter, costs increase and dietary standards and eating habits, and that providing nutritious food with more guidelines become more stringent. These trends affect fiber, less fat and fewer calories was actually a public health menu planning, medical diet programs and overall food opportunity.” service operations. Corrections dietitians are tasked with Providing a healthy diet is “part and parcel” of the jail developing nutritionally adequate menus and therapeutic system’s mission to provide care, custody and control, Horn diets while staying within budget constraints. adds, and is in keeping with the goals of a citywide nutrition Earlier this year, media coverage of healthy meals in task force established by Mayor Michael Bloomberg. “We the New York City Department of Corrections sparked serve 42,000 healthy meals every day, many to inmates who extensive discussion among corrections dietitians. Across are in our custody a short time,” he says. “Nutritious food the nation, more and more menu modifications are being can be served at no greater cost than less healthy food, and made to control costs, and the initial changes are often it’s our hope that detainees and sentenced inmates benefit through eliminating or reducing items such as coffee, sugar, from the nutrition while they are with us and after they fat and milk, either in type or quantity. The good news is return to the community.” that these alterations are resulting in more heart-healthy Horn has reported that the recent menu changes have menus, which should lead to better health outcomes. had no net effect on food costs, which he says are about This article highlights some of the approaches being $2.50 per inmate per day. taken in various jurisdictions. Sampling the Fare Nutrition in New York City Research for this article found that other correctional sys- According to Paulette Johnson, MS, RD, CDN, assistant tems are using a variety of cost-cutting measures that have commissioner of the NYC DOC nutrition services division, contributed to healthier menu offerings. Most commonly, the agency has made many changes toward achieving a these efforts focus on eliminating or reducing usage of heart-healthy menu, such as eliminating or reducing sugar coffee, sugars, fats and sodium, and reducing or switching and butter. Below are some details of the menu: to a different type of milk, including fortified milk substitutes. While such practices have been the norm (in varying Sugar degrees) in some systems for awhile, they are becoming a • Effective July 2008, all desserts such as baked goods, ice trend across the country as administrators strive to reduce cream and canned pudding are sugar-free. costs and improve outcomes. • The one exception is cake, served only on holidays. Carrot In Michigan, the state Department of Corrections has cake will be served for Thanksgiving and Christmas. been serving a “healthy choice” menu since 2001. In addi- • Sugar-free muffins are served once per week. tion to serving skim milk, facilities offer a choice of dessert • Canned fruits are packed in natural juice. or fruit (fresh and juice-packed); regular and dietetic jelly, • Sugar packets are still available. sweeteners, salad dressings and beverages; and meat and meatless entrees. Fat This proactive, “choice” approach has reduced the need • Butter has been replaced with margarine. for therapeutic diet trays, says foodservice program manag- • 1% and skim milk are the only types of milk served now. er Gatha McClellan, RD. “It also increases flexibility in place- • Trans-fats were eliminated from NYC jails six months ment of prisoners and reduces cost of prisoner transfers.” before the city banned them in restaurants. Significantly, it also has led to stable food costs over the • Fried foods have not been served for more than a decade. past four years, with average per capita meal costs actually a few cents lower in 2006 and 2007 compared to the two Fiber years prior. “We do not believe the choice menu increases • Fiber content has increased by offering whole wheat bread food cost because prisoners frequently take the less and fiber-rich cereals. expensive item and they take only the food they will eat,” ·• Fresh fruit is served daily. McClellan notes. Sodium But 2008 is proving to be more of a challenge, with • Low-sodium products are served. This includes processed major price increases in various foods. To offset the higher meats, prepared entrees and canned vegetables. prices, the DOC plans to make some menu changes, such as using less costly vegetables, eliminating the option for a In addition, nutrition classes are conducted for inmates who are on therapeutic diets. continued on page 19

18 Summer 2008 • CorrectCare www.ncchc.org (continued)

third slice of bread and decreasing calories. But good nutri- therapeutic diets, with an end result of lower costs in both tion remains the focus: “We do not plan on using imita- food services and health services. tion foods, which would be a quick fix but in the long run A caveat, though, is that all of these measures can reduce would increase health care costs,” McClellan says. Planned overall calories, which must be considered when a calorie operational changes will also help shave expenses. requirement is part of the jurisdiction’s standards. In January, the Federal Bureau of Prisons implemented Also, food service programs that give inmates the option a national menu that incorporates healthy alternatives, of choosing healthier foods are usually feasible only in sys- according to Tom tems or facilities that have Issermoyer, the cafeteria-style meal service. FBOP’s national food service administra- Nutrient and Cost tor. It is similar to Trends the Michigan menu Numerous factors come and also offers heart- into play when correctional healthy alternative facilities seek to make entrées along with informed decisions about meat-free entrées. diet changes. The Minnesota Department of Cost-Per-Nutrient Values Corrections has This term has not come approved the adop- into common parlance, tion of heart-healthy but the practice of evaluat- menu standards, to ing the cost per nutrient begin in 2010. The is becoming more wide- menu is based pri- spread when modifying marily on the 2005 correctional menus. Dietary Guidelines for Eliminating or limiting Americans issued by “empty” calories such as the U.S. Department coffee and sugar reduces of Health and Human Services and the U.S. Department nonnutritive costs as well as overall calories. This has a posi- of Agriculture. The guidelines provide authoritative advice tive effect on health concerns related to obesity, diabetes about how good dietary habits can promote health and and cardiac disease, among others. Likewise, eliminating or reduce risk for major chronic diseases. They also are the limiting margarine and fried foods reduces overall intake of basis for federal food and nutrition education programs. calories and fats, with a corresponding impact on cardiac The committee responsible for implementation is still disease and weight management along with overall health. developing the specific approaches and timelines for meet- Removing sugar and fats opens the door for more nutrient- ing the new guidelines. For example, they must make deci- dense foods such as fruit to be offered in place of baked sions on the use of skim milk, sugar-free soda, fish and veg- sweets. This boosts intake of vitamins, minerals and fiber etable bars. Plans are already in place, though, to create salt- and reduces sodium intake. free and low-fat recipes and to explore meatless entrees. In the Los Angeles County jail system, Benson Li, man- Milk/Dairy Alternatives ager of the food services unit, serves approximately 21,500 Currently, milk is served as often as three times daily on inmates. This includes meals to those housed in a 200-bed general population menus in America’s correctional institu- treatment center and more than 1,600 medical diets for tions. California law mandates three servings of milk and/or outpatients. The meals, which omit coffee, sugar and mar- milk products daily in jails, while Wisconsin, a dairy-produc- garine, cost about $2.50 per inmate per day. ing state can afford to offer three servings. The system operates under a state regulation known as However, rising prices of dairy products are prompting Title 15, which governs all county jails in California and has corrections dietitians to consider cost-effective substitutes some of the most stringent jail food service standards in the that meet nutritional needs. Not surprisingly, milk alter- nation. At the county level, the Board of Supervisors has a natives and fortified foods are growing more popular as zero trans-fat mandate, copied from New York, and since supplements or even replacements for liquid milk. July has required the use of environmentally friendly chemi- In an effort to control costs, some facilities are switching cals and disposable wares. to fat-free skim milk and still further limiting liquid milk to Overall, offering heart-healthy alternatives is consistent one serving per day or less. Many are using powdered milk with the 2005 Dietary Guidelines in terms of increased for drinking as well as cooking. This reduction in the quan- fiber, controlled fat, reduced sodium and food variety. In tity of milk served has opened the door for fortified milk combination with education on nutrition and diet, this contributes to positive overall health and reduced need for continued on page 20

19 www.ncchc.org Summer 2008 • CorrectCare (continued)Diets (continued from page 19)

replacement beverages and other nutrient fortified prod- Bread Products ucts such as puddings and bread dough. Some correctional kitchens are making their own bread These modifications in milk usage contribute to an products (from scratch or mix) to help offset the costs of overall reduction of fats, cholesterol and calories provided, purchased, sliced bread. Fresh-made items such as biscuits, which again is beneficial to health. But care must be taken cornbread, dinner rolls and buns are appearing on main to ensure that similar nutrient needs are met using these population menus and diet menus, when possible. A typi- alternate milk choices. cal serving of cornbread provides calories and fiber similar In fact, some have questioned whether use of these to that of two slices of bread, but much more economically. products violates the NCCHC Standards for Health Services. Dinner rolls and buns also provide a fresh quality product, The Standards recognize the importance of diet in main- can be made a defined size and allow for the use of whole taining health. In the 2008 editions for jails and prisons, wheat flour, which improves the nutrient and fiber content. standard F-01 Healthy Lifestyle Promotion recommends To increase desirable nutrients, one company even manu- serving appropriate diets that are based on the principles factures a calcium-fortified bread dough for the corrections expressed in the government’s MyPyramid food guidance market. system and that meet the recommended dietary allow- ances of nutrients. Proper nutrition is particularly important Other Trends for adolescents, so the standards for juvenile facilities go • Education. Teaching inmates about nutrition and diet into even more detail. education is becoming more popular. The information is According to NCCHC, milk and dairy products are opti- typically provided from the medical department in the mal, but use of substitutes approved by nutritional experts form of a handout, according to a recent survey of correc- as being nutritionally adequate would be in compliance tions dietitians. This knowledge enables inmates to under- with the standards. Certain populations, such as those on stand their nutritional needs, both for general and medical special medical diets or adolescents, may be exceptions and diets, and to make healthier food choices. such should be clearly spelled out in directives issued jointly • Fuel surcharges. In addition to rising food prices, fuel by the medical director and dietitian consultant. surcharges for food deliveries are becoming more common. This is yet another factor to consider in cost containment. • Fortified foods. Many corrections suppliers are creating foods designed to help meet nutrient requirements economically. Fortified beverages, puddings/desserts and bread dough are common, as are reduced-sodium meats. Join the Academy of Getting More With Less Moving toward more heart-healthy options by limiting Correctional Health Professionals today! empty calories and offering nutrient-dense foods ultimately reduces the overall costs associated with both food service Membership in the Academy is an unmistakable sign of your and health care needs. These trends are consistent with the commitment to professionalism and adherence to the highest standards in this À eld. rationale of the NCCHC standards. Surprisingly, not all administrators view these trends as a Benefi ts of Membership positive for the climate in their facilities; some still believe Journal of Correctional Health Care: Receive a free subscription (a $102 value) to the only national, peer-reviewed journal with an that they must keep inmates full and happy at mealtime exclusive focus on correctional health care, and earn continuing to avoid potential security problems. But the long-term education credit. outcome—healthier inmates, lower expenses —is a perfect SJO Online: Academy members have exclusive access to the Journal example of getting more with less. online and can link to the full text of cited articles of other journals hosted on the SJO. CorrectCare™: Receive a free subscription to the nation’s most Barbara Wakeen, MA, RD, LD, is the principal of Correctional widely read magazine dedicated to correctional health care. Nutrition Consultants and is based in North Canton, OH. Shared Interest Groups: Join small, focused gatherings and online She represents the American Dietetic Association on the discussions devoted to speciÀ c topics and sectors of interest to you. NCCHC board of directors and contributed the Dietary Mentor Program: Develop a professional relationship with a mentor Guidelines appendix to NCCHC’s 2008 Standards. She also who will support your professional advancement. is the author of Nutrition and Foodservice Management in Web Site: Access the membership directory and other features Correctional Facilities, 3rd Edition. To reach her, e-mail bwa- available only to members on our Web site. [email protected]. Member Discounts: Save money on all Academy and NCCHC publications and conferences. The Academy — your professional community for correctional health care.

20 Academy Ad for CC_qrtr 08.inddSummer 1 2008 • CorrectCare 2/22/08 5:10:33 PM www.ncchc.org *

Please see brief summary of Full Prescribing Information for SUSTIVA on the following pages. *In HIV combination therapy

Important Information about SUSTIVA® (efavirenz) INDICATION: Full page Ad SUSTIVA in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on two clinical trials of at least one year duration that demonstrated prolonged8” suppression x 10 of 1/2”HIV RNA. IMPORTANT SAFETY INFORMATION: • Coadministration with astemizole, bepridil, cisapride, midazolam, • SUSTIVA may cause fetal harm when administered during the first pimozide, triazolam, ergot derivatives, or standard doses of voriconazole trimester to a pregnant woman. Women should not become pregnant or is contraindicated. If SUSTIVA is coadministered with voriconazole,Page 21breast-feed while taking SUSTIVA. Barrier contraception must always be the voriconazole maintenance dose should be increased to 400 mg used in combination with other methods of contraception (eg, oral or other every 12 hours and the SUSTIVA dose should be decreased to 300 mg hormonal contraceptives). Because of the long half-life of efavirenz, once daily using the capsule formulation. SUSTIVA tablets should not adequate contraceptive measures are recommended for 12 weeks after be broken. discontinuation of SUSTIVA. If the patient becomes pregnant while taking SUSTIVA, she should be apprised of the potential harm to the fetus. • Concomitant use of SUSTIVA and St. John’s wort (Hypericum perforatum) or St. John’s wort-containing products is not recommended. • Mild-to-moderate rash is a common side effect of SUSTIVA. In controlled ® clinical trials, 26% of patients treated with SUSTIVA experienced new- • Coadministration of SUSTIVA with ATRIPLA (efavirenz 600 mg/ onset skin rash compared with 17% of patients treated in control groups. emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is not SUSTIVA should be discontinued in patients developing severe rash recommended, since efavirenz is one of its active ingredients. associated with blistering, desquamation, mucosal involvement, or fever. • Serious psychiatric adverse experiences, including severe depression (2.4%), Rash is more common and often more severe in pediatric patients. suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive • Liver enzymes should be monitored in patients with known or suspected behavior (0.4%), paranoid reactions (0.4%), and manic reactions (0.2%), hepatitis B or C, in patients treated with other medications associated with have been reported in patients treated with SUSTIVA. In addition to liver toxicity, and when SUSTIVA is administered with ritonavir. SUSTIVA, factors identified in a clinical study that were associated with • Use SUSTIVA with caution in patients with a history of seizures. an increase in psychiatric symptoms included history of injection drug use, Convulsions have been observed in patients receiving efavirenz, generally psychiatric history, and use of psychiatric medication. There have been in the presence of known medical history of seizures. occasional reports of suicide, delusions, and psychosis-like behavior, but it could not be determined if SUSTIVA was the cause. Patients with serious • Redistribution and/or accumulation of body fat have been seen in patients psychiatric adverse experiences should be evaluated immediately to receiving antiretroviral therapy. A causal relationship has not been determine whether the risks of continued therapy outweigh the benefits. established. • Fifty-three percent of patients reported central nervous system symptoms, • Immune reconstitution syndrome has been reported in patients treated including dizziness (28.1%), insomnia (16.3%), impaired concentration with combination antiretroviral therapy, including SUSTIVA. (8.3%), somnolence (7.0%), abnormal dreams (6.2%), and hallucinations • Saquinavir should not be used as the only protease inhibitor in (1.2%), when taking SUSTIVA compared to 25% of patients receiving combination with SUSTIVA. Please see the SUSTIVA Full Prescribing control regimens. These symptoms usually begin during Days 1-2 of Information for complete list of drug interactions. therapy and generally resolve after the first 2-4 weeks of therapy; they • The most common adverse events (*5%) observed in clinical studies with were severe in 2.0% of patients and 2.1% of patients discontinued therapy. SUSTIVA include fatigue, pain, dizziness, headache, insomnia, impaired After 4 weeks of therapy, the prevalence of nervous system symptoms of concentration, nausea, vomiting, diarrhea, depression, rash, and pruritus. at least moderate severity ranged from 5% to 9% in patients treated with The dose of SUSTIVA is one tablet once daily taken orally on an empty regimens containing SUSTIVA. Nervous system symptoms are not stomach, preferably at bedtime, in combination therapy. predictive of less frequent serious psychiatric symptoms. The increased concentrations following administration of SUSTIVA with food may lead to an increase in frequency of adverse events. Dosing at bedtime may improve the tolerability of nervous system symptoms.

SUSTIVA and the SUNRISE LOGO are registered trademarks of Bristol-Myers Squibb Pharma Company. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks are owned by third parties. ©2008 Bristol-Myers Squibb Company, Princeton, NJ 08543. 692US08AB00303 04/08 ® Patients should be informed that SUSTIVA (efavirenz) is not a cure for HIV-1 infection and that they may continue to develop opportunistic SUSTIVA infections and other complications associated with HIV-1 disease. Patients should be told that there are currently no data demonstrating (efavirenz) capsules and tablets that SUSTIVA therapy can reduce the risk of transmitting HIV to others through sexual contact or blood contamination. Brief summary of Prescribing Information, 03-08. For complete prescribing information, please consult official package insert. Patients should be advised to take SUSTIVA every day as prescribed. SUSTIVA must always be used in combination with other antiretroviral drugs. Patients should be advised to take SUSTIVA on an empty stomach, preferably at bedtime. Taking SUSTIVA with food CONTRAINDICATIONS increases efavirenz concentrations and may increase the frequency of adverse events. Dosing at bedtime may improve the tolerability SUSTIVA (efavirenz) is contraindicated in patients with clinically significant hypersensitivity to any of its components. of nervous system symptoms (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION in Full Prescribing Information). SUSTIVA should not be administered concurrently with astemizole, bepridil, cisapride, midazolam, pimozide, triazolam, or ergot Patients should remain under the care of a physician while taking SUSTIVA. derivatives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential Patients should be informed that central nervous system symptoms including dizziness, insomnia, impaired concentration, drowsiness, for serious and/or life-threatening adverse events (eg, cardiac arrhythmias, prolonged sedation, or respiratory depression). SUSTIVA and abnormal dreams are commonly reported during the first weeks of therapy with SUSTIVA. Dosing at bedtime may improve the should not be administered concurrently with standard doses of voriconazole because SUSTIVA significantly decreases voriconazole tolerability of these symptoms, and these symptoms are likely to improve with continued therapy. Patients should be alerted to the potential plasma concentrations. Adjusted doses of voriconazole and efavirenz may be administered concomitantly (see CLINICAL for additive central nervous system effects when SUSTIVA is used concomitantly with alcohol or psychoactive drugs. Patients should be PHARMACOLOGY, Tables 1 and 2 in Full Prescribing Information; PRECAUTIONS, Drugs That Are Contraindicated or Not instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machinery Recommended for Use with SUSTIVA; and DOSAGE AND ADMINISTRATION: Dosage Adjustment in Full Prescribing Information). (see WARNINGS: Nervous System Symptoms). In clinical trials, patients who develop central nervous system symptoms were not more WARNINGS likely to subsequently develop psychiatric symptoms (see WARNINGS: Psychiatric Symptoms). ALERT: Find out about medicines that should NOT be taken with SUSTIVA. This statement is also included on the product’s bottle Patients should also be informed that serious psychiatric symptoms including severe depression, suicide attempts, aggressive labels. (See CONTRAINDICATIONS and PRECAUTIONS: Drug Interactions.) behavior, delusions, paranoia, and psychosis-like symptoms have also been reported in patients receiving SUSTIVA. Patients should be SUSTIVA must not be used as a single agent to treat HIV-1 infection or added on as a sole agent to a failing regimen. As with all other informed that if they experience severe psychiatric adverse experiences they should seek immediate medical evaluation to assess the non-nucleoside reverse transcriptase inhibitors, resistant virus emerges rapidly when efavirenz is administered as monotherapy. The possibility that the symptoms may be related to the use of SUSTIVA, and if so, to determine whether discontinuation of SUSTIVA may be choice of new antiretroviral agents to be used in combination with efavirenz should take into consideration the potential for viral required. Patients should also inform their physician of any history of mental illness or substance abuse (see WARNINGS: Psychiatric cross-resistance. ® Symptoms). Coadministration of SUSTIVA with ATRIPLA (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) is not recommended, since Patients should be informed that another common side effect is rash. These rashes usually go away without any change in treatment. efavirenz is one of its active ingredients. In a small number of patients, rash may be serious. Patients should be advised that they should contact their physician promptly if they Psychiatric Symptoms: Serious psychiatric adverse experiences have been reported in patients treated with SUSTIVA. In controlled develop a rash. trials of 1008 patients treated with regimens containing SUSTIVA for a mean of 2.1 years and 635 patients treated with control regimens Women receiving SUSTIVA should be instructed to avoid pregnancy (see WARNINGS: Reproductive Risk Potential). A reliable form for a mean of 1.5 years, the frequency of specific serious psychiatric events among patients who received SUSTIVA or control regimens, of barrier contraception should always be used in combination with other methods of contraception, including oral or other hormonal respectively, were: severe depression (2.4%, 0.9%), suicidal ideation (0.7%, 0.3%), nonfatal suicide attempts (0.5%, 0%), aggressive contraception, because the effects of efavirenz on hormonal contraceptives are not fully characterized. Because of the long half-life of behavior (0.4%, 0.5%), paranoid reactions (0.4%, 0.3%), and manic reactions (0.2%, 0.3%).When psychiatric symptoms similar to those efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of SUSTIVA is recommended. Women should be noted above were combined and evaluated as a group in a multifactorial analysis of data from Study 006, treatment with efavirenz was advised to notify their physician if they become pregnant while taking SUSTIVA. If this drug is used during the first trimester of pregnancy, associated with an increase in the occurrence of these selected psychiatric symptoms. Other factors associated with an increase in the or if the patient becomes pregnant while taking this drug, she should be apprised of the potential harm to the fetus. occurrence of these psychiatric symptoms were history of injection drug use, psychiatric history, and receipt of psychiatric medication SUSTIVA may interact with some drugs; therefore, patients should be advised to report to their doctor the use of any other prescription, at study entry; similar associations were observed in both the SUSTIVA and control treatment groups. In Study 006, onset of new serious psychiatric symptoms occurred throughout the study for both SUSTIVA-treated and control-treated patients. One percent of SUSTIVA- nonprescription medication, or herbal products, particularly St. John’s wort. treated patients discontinued or interrupted treatment because of one or more of these selected psychiatric symptoms. There have also Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and been occasional postmarketing reports of death by suicide, delusions, and psychosis-like behavior, although a causal relationship to the that the cause and long-term health effects of these conditions are not known at this time. use of SUSTIVA cannot be determined from these reports. Patients with serious psychiatric adverse experiences should seek immediate Drug Interactions (see also CONTRAINDICATIONS and CLINICAL PHARMACOLOGY: Drug Interactions in Full Prescribing medical evaluation to assess the possibility that the symptoms may be related to the use of SUSTIVA, and if so, to determine whether Information) the risks of continued therapy outweigh the benefits (see ADVERSE REACTIONS). Efavirenz has been shown in vivo to induce CYP3A4. Other compounds that are substrates of CYP3A4 may have decreased plasma Nervous System Symptoms: Fifty-three percent of patients receiving SUSTIVA in controlled trials reported central nervous system concentrations when coadministered with SUSTIVA. In vitro studies have demonstrated that efavirenz inhibits 2C9, 2C19, and 3A4 symptoms compared to 25% of patients receiving control regimens.These symptoms included, but were not limited to, dizziness (28.1%), isozymes in the range of observed efavirenz plasma concentrations. Coadministration of efavirenz with drugs primarily metabolized by insomnia (16.3%), impaired concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%), and hallucinations (1.2%). These these isozymes may result in altered plasma concentrations of the coadministered drug. Therefore, appropriate dose adjustments may symptoms were severe in 2.0% of patients, and 2.1% of patients discontinued therapy as a result.These symptoms usually begin during be necessary for these drugs. 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 Drugs which induce CYP3A4 activity (eg, phenobarbital, rifampin, rifabutin) would be expected to increase the clearance of efavirenz nervous system symptoms of at least moderate severity ranged from 5% to 9% in patients treated with regimens containing SUSTIVA resulting in lowered plasma concentrations. Drug interactions with SUSTIVA are summarized in the following paragraphs and in Tables and from 3% to 5% in patients treated with a control regimen. Patients should be informed that these common symptoms were 5 and 6 in Full Prescribing Information. The following include potentially significant interactions, but are not all inclusive. likely to improve with continued therapy and were not predictive of subsequent onset of the less frequent psychiatric symptoms Drugs That Are Contraindicated or Not Recommended for Use With SUSTIVA: For clinical comment, please see Table 5 in Full (see WARNINGS: Psychiatric Symptoms). Dosing at bedtime may improve the tolerability of these nervous system symptoms Prescribing Information. (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION in Full Prescribing Information). Antifungal: voriconazole at standard doses. When voriconazole is coadministered with SUSTIVA, voriconazole maintenance dose should Analysis of long-term data from Study 006 (median follow-up 180 weeks, 102 weeks, and 76 weeks forFull patients treated page with SUSTIVA + Adbe increased to 400 mg every 12 hours and SUSTIVA dose should be decreased to 300 mg once daily using the capsule formulation. zidovudine + lamivudine, SUSTIVA + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of SUSTIVA tablets should not be broken. (See CLINICAL PHARMACOLOGY, Tables 1 and 2 in Full Prescribing Information; therapy, the incidences of new-onset nervous system symptoms among SUSTIVA-treated patients were generally similar to those in the CONTRAINDICATIONS; PRECAUTIONS, Table 5 in Full Prescribing Information; and DOSAGE AND ADMINISTRATION: Dosage indinavir-containing control arm. Adjustment in Full Prescribing Information). Patients receiving SUSTIVA should be alerted to the potential for additive central nervous system effects when SUSTIVA is used Antihistamine: astemizole; Antimigraine: ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); concomitantly with alcohol or psychoactive drugs. Patients who experience central nervous system 8”symptoms x such 10as dizziness, 1/2”Benzodiazepines: midazolam, triazolam; Calcium channel blocker: bepridil; GI motility agent: cisapride; Neuroleptic: pimozide; St. John’s impaired concentration, and/or drowsiness should avoid potentially hazardous tasks such as driving or operating machinery. wort (Hypericum perforatum). Drug Interactions: Concomitant use of SUSTIVA and St. John’s wort (Hypericum perforatum) or St. John’s wort-containing products is Established and Other Potentially Significant Drug Interactions*: Alteration in Dose or Regimen May Be Recommended Based not recommended. Coadministration of non-nucleoside reverse transcriptase inhibitors (NNRTIs), including SUSTIVA, with on Drug Interaction Studies or Predicted Interaction St. John’s wort is expected to substantially decrease NNRTI concentrations and may result in suboptimal levels of efavirenz and lead to loss of virologic response and possible resistance to efavirenz or to the class of NNRTIs. Page 22Antiretroviral Agents Reproductive Risk Potential: Pregnancy Category D. Efavirenz may cause fetal harm when administered during the first trimester to Protease Inhibitors – Amprenavir: ?amprenavir concentration. SUSTIVA has the potential to decrease serum concentrations of a pregnant woman. Pregnancy should be avoided in women receiving SUSTIVA. Barrier contraception should always be used in amprenavir. Fosamprenavir calcium: ?amprenavir concentration. Fosamprenavir (unboosted): Appropriate doses of the combinations combination with other methods of contraception (eg, oral or other hormonal contraceptives). Because of the long half-life of efavirenz, with respect to safety and efficacy have not been established. Fosamprenavir/ritonavir: An additional 100 mg/day (300 mg total) of use of adequate contraceptive measures for 12 weeks after discontinuation of SUSTIVA is recommended. Women of childbearing ritonavir is recommended when SUSTIVA is administered with fosamprenavir/ritonavir once daily. No change in the ritonavir dose is potential should undergo pregnancy testing before initiation of SUSTIVA. If this drug is used during the first trimester of pregnancy, or if required when SUSTIVA is administered with fosamprenavir plus ritonavir twice daily. Atazanavir: ?atazanavir concentration. When the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. coadministered with SUSTIVA in treatment-naive patients, the recommended dose of atazanavir is 300 mg with ritonavir 100 mg and There are no adequate and well-controlled studies in pregnant women. SUSTIVA should be used during pregnancy only if the potential SUSTIVA 600 mg (all once daily). Dosing recommendations for SUSTIVA and atazanavir in treatment-experienced patients have not benefit justifies the potential risk to the fetus, such as in pregnant women without other therapeutic options. As of July 2007, the been established. Indinavir: ?indinavir concentration. The optimal dose of indinavir, when given in combination with SUSTIVA, is not Antiretroviral Pregnancy Registry has received prospective reports of 373 pregnancies exposed to efavirenz-containing regimens, nearly known. Increasing the indinavir dose to 1000 mg every 8 hours does not compensate for the increased indinavir metabolism due to all of which were first-trimester exposures (359 pregnancies). Birth defects occurred in 7 of 295 live births (first-trimester exposure) and SUSTIVA. When indinavir at an increased dose (1000 mg every 8 hours) was given with SUSTIVA (600 mg once daily), the indinavir 1 of 26 live births (second/third-trimester exposure). None of these prospectively reported defects were neural tube defects. However, AUC and Cmin were decreased on average by 33-46% and 39-57%, respectively, compared to when indinavir (800 mg every 8 hours) there have been five retrospective reports of findings consistent with neural tube defects, including meningomyelocele. All mothers were was given alone. Lopinavir/ritonavir: ?lopinavir concentration. Lopinavir/ritonavir tablets should not be administered once-daily in exposed to efavirenz-containing regimens in the first trimester. Although a causal relationship of these events to the use of SUSTIVA has combination with SUSTIVA. In antiretroviral-naive patients, lopinavir/ritonavir tablets can be used twice daily in combination with not been established, similar defects have been observed in preclinical studies of efavirenz. SUSTIVA with no dose adjustment. A dose increase of lopinavir/ritonavir tablets to 600/150 mg (3 tablets) twice daily may be considered Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to SUSTIVA, an Antiretroviral Pregnancy when used in combination with SUSTIVA in treatment-experienced patients where decreased susceptibility to lopinavir is clinically Registry has been established. Physicians are encouraged to register patients by calling (800) 258-4263. suspected (by treatment history or laboratory evidence). A dose increase of lopinavir/ritonavir oral solution to 533/133 mg (6.5 mL) PRECAUTIONS twice daily taken with food is recommended when used in combination with SUSTIVA. Ritonavir: Britonavir concentration, Befavirenz General concentration. When ritonavir 500 mg every 12 hours was coadministered with SUSTIVA 600 mg once daily, the combination was Skin Rash: In controlled clinical trials, 26% (266/1008) of patients treated with 600 mg SUSTIVA experienced new-onset skin rash associated with a higher frequency of adverse clinical experiences (eg, dizziness, nausea, paresthesia) and laboratory abnormalities compared with 17% (111/635) of patients treated in control groups. Rash associated with blistering, moist desquamation, or ulceration (elevated liver enzymes). Monitoring of liver enzymes is recommended when SUSTIVA is used in combination with ritonavir. Saquinavir: occurred in 0.9% (9/1008) of patients treated with SUSTIVA. The incidence of Grade 4 rash (eg, erythema multiforme, Stevens-Johnson ?saquinavir concentration. Should not be used as sole protease inhibitor in combination with SUSTIVA. syndrome) in patients treated with SUSTIVA in all studies and expanded access was 0.1%. The median time to onset of rash in adults Other Agents was 11 days and the median duration, 16 days. The discontinuation rate for rash in clinical trials was 1.7% (17/1008). SUSTIVA should Anticoagulant – Warfarin:B or ?warfarin concentration. Plasma concentrations and effects potentially increased or decreased by be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever. Appropriate SUSTIVA. Anticonvulsants – Carbamazepine: ?carbamazepine concentration, ?efavirenz concentration. There are insufficient data antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash. to make a dose recommendation for efavirenz. Alternative anticonvulsant treatment should be used. Phenytoin, Phenobarbital: Rash was reported in 26 of 57 pediatric patients (46%) treated with SUSTIVA capsules. One pediatric patient experienced Grade 3 rash ?anticonvulsant concentration, ?efavirenz concentration. Potential for reduction in anticonvulsant and/or efavirenz plasma levels; (confluent rash with fever), and two patients had Grade 4 rash (erythema multiforme). The median time to onset of rash in pediatric periodic monitoring of anticonvulsant plasma levels should be conducted. Antidepressant – Sertraline: ?sertraline concentration. patients was 8 days. Prophylaxis with appropriate antihistamines prior to initiating therapy with SUSTIVA in pediatric patients should be Increases in sertraline dose should be guided by clinical response. Antifungals – Itraconazole: ?itraconazole, ?hydroxyitraconazole considered (see ADVERSE REACTIONS). concentrations. Since no dose recommendation for itraconazole can be made, alternative antifungal treatment should be considered. Liver Enzymes: In patients with known or suspected history of hepatitis B or C infection and in patients treated with other medications Ketoconazole: ?ketoconazole concentration. Drug interaction studies with SUSTIVA and ketoconazole have not been conducted. associated with liver toxicity, monitoring of liver enzymes is recommended. In patients with persistent elevations of serum transaminases SUSTIVA has the potential to decrease plasma concentrations of ketoconazole. (See PRECAUTIONS, Drugs That Are to greater than five times the upper limit of the normal range, the benefit of continued therapy with SUSTIVA needs to be weighed against Contraindicated or Not Recommended for Use With SUSTIVA and Table 5 in Full Prescribing Information for guidance on the unknown risks of significant liver toxicity (see ADVERSE REACTIONS: Laboratory Abnormalities). coadministration with adjusted doses of voriconazole). Anti-infective – Clarithromycin: ?clarithromycin, B14-OH metabolite concen- Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic trations. Plasma concentrations decreased by SUSTIVA; clinical significance unknown. In uninfected volunteers, 46% developed rash impairment, caution should be exercised in administering SUSTIVA to these patients. while receiving SUSTIVA and clarithromycin. No dose adjustment of SUSTIVA is recommended when given with clarithromycin. Convulsions: Convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of Alternatives to clarithromycin, such as azithromycin, should be considered (see PRECAUTIONS: Other Drugs in Full Prescribing seizures. Caution must be taken in any patient with a history of seizures. Patients who are receiving concomitant anticonvulsant Information). Other macrolide antibiotics, such as erythromycin, have not been studied in combination with SUSTIVA. medications primarily metabolized by the liver, such as phenytoin and phenobarbital, may require periodic monitoring of plasma levels Antimycobacterials – Rifabutin: ?rifabutin concentration. Increase daily dose of rifabutin by 50%. Consider doubling the rifabutin (see PRECAUTIONS: Drug Interactions). dose in regimens where rifabutin is given 2 or 3 times a week. Rifampin: ?efavirenz concentration. Clinical significance of reduced Cholesterol: Monitoring of cholesterol and triglycerides should be considered in patients treated with SUSTIVA (see ADVERSE REACTIONS). efavirenz concentrations is unknown. Dosing recommendations for concomitant use of SUSTIVA and rifampin have not been Fat Redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), established. Calcium channel blockers – Diltiazem: ?diltiazem, ?desacetyl diltiazem, ?N-monodesmethyl diltiazem concen- peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving trations. Diltiazem dose adjustments should be guided by clinical response (refer to complete prescribing information for diltiazem). antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has No dose adjustment of efavirenz is necessary when administered with diltiazem. Others (eg, felodipine, nicardipine, nifedipine, not been established. verapamil): ?calcium channel blocker concentration. No data are available on the potential interactions of efavirenz with other Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination calcium channel blockers that are substrates of the CYP3A4 enzyme. The potential exists for reduction in plasma concentrations of antiretroviral therapy, including SUSTIVA. During the initial phase of combination antiretroviral treatment, patients whose immune system the calcium channel blocker. Dose adjustments should be guided by clinical response (refer to the complete prescribing information responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, for the calcium channel blocker). HMG-CoA reductase inhibitors – Atorvastatin: ?atorvastatin concentration, Pravastatin: cytomegalovirus, Pneumocystis jiroveci pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. ?pravastatin concentration, Simvastatin: ?simvastatin concentration. Plasma concentrations of atorvastatin, pravastatin, and Information for Patients: A statement to patients and healthcare providers is included on the product’s bottle labels: ALERT: Find simvastatin decreased. Consult the complete prescribing information for the HMG-CoA reductase inhibitor for guidance on individ- out about medicines that should NOT be taken with SUSTIVA. A Patient Package Insert (PPI) for SUSTIVA is available for patient ualizing the dose. Narcotic analgesic – Methadone: ?methadone concentration. Coadministration in HIV-infected individuals with a information. 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 Table 1: Selected Treatment-Emergenta Adverse Events of Moderate or Severe Intensity Reported in *2% of methadone dose increased as required to alleviate withdrawal symptoms. Oral contraceptive – Ethinyl estradiol: Bethinyl estradiol SUSTIVA (efavirenz)-Treated Patients in Studies 006 and ACTG 364 (continued) concentration. Plasma concentrations increased by SUSTIVA (efavirenz); clinical significance unknown. The potential interaction of efavirenz with oral contraceptives has not been fully characterized. A reliable method of barrier contraception should be used in Study 006: LAM-, NNRTI-, and Study ACTG 364: NRTI-experienced, addition to oral contraceptives. Protease Inhibitor-Naive Patients NNRTI- and Protease Inhibitor-Naive Patients *Please see, in Full Prescribing Information, Tables 1, 2, 5 and 6 and PRECAUTIONS: Other Drugs for additional information. SUSTIVAb SUSTIVAb Indinavir SUSTIVAb SUSTIVAb Nelfinavir Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term carcinogenicity studies in mice and rats were carried out + ZDV/LAM + Indinavir + ZDV/LAM + Nelfinavir + NRTIs + NRTIs + NRTIs with efavirenz. Mice were dosed with 0, 25, 75, 150, or 300 mg/kg/day for 2 years. Incidences of hepatocellular adenomas and (n=412) (n=415) (n=401) (n=64) (n=65) (n=66) carcinomas and pulmonary alveolar/bronchiolar adenomas were increased above background in females. No increases in tumor incidence Adverse Events 180 weeksc 102 weeksc 76 weeksc 71.1 weeksc 70.9 weeksc 62.7 weeksc above background were seen in males. In studies in which rats were administered efavirenz at doses of 0, 25, 50, or 100 mg/kg/day for Gastrointestinal 2 years, no increases in tumor incidence above background were observed. The systemic exposure (based on AUCs) in mice was Nausea 10% 6% 24% 3% 2% 2% approximately 1.7-fold that in humans receiving the 600-mg/day dose. The exposure in rats was lower than that in humans. The Vomiting 6% 3% 14% — — — mechanism of the carcinogenic potential is unknown. However, in genetic toxicology assays, efavirenz showed no evidence of mutagenic Diarrhea 3% 5% 6% 14% 3% 9% or clastogenic activity in a battery of in vitro and in vivo studies. These included bacterial mutation assays in S. typhimurium and E. coli, mammalian mutation assays in Chinese hamster ovary cells, chromosome aberration assays in human peripheral blood lymphocytes or Dyspepsia 4% 4% 6% 0 0 2% Chinese hamster ovary cells, and an in vivo mouse bone marrow micronucleus assay. Given the lack of genotoxic activity of efavirenz, the Abdominal pain 2% 2% 5% 3% 3% 3% relevance to humans of neoplasms in efavirenz-treated mice is not known. Psychiatric Efavirenz did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats. The reproductive Anxiety 2% 4% <1% — — — performance of offspring born to female rats given efavirenz was not affected. As a result of the rapid clearance of efavirenz in rats, systemic Depression 5% 4% <1% 3% 0 5% drug exposures achieved in these studies were equivalent to or below those achieved in humans given therapeutic doses of efavirenz. Nervousness 2% 2% 0 2% 0 2% Pregnancy Skin & Appendages Pregnancy Category D: See WARNINGS: Reproductive Risk Potential. Rash 11% 16% 5% 9% 5% 9% Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breast-feed their Pruritus <1% 1% 1% 9% 5% 9% infants to avoid risking postnatal transmission of HIV. Although it is not known if efavirenz is secreted in human milk, efavirenz is a Includes adverse events at least possibly related to study drug or of unknown relationship for Study 006. Includes all adverse secreted into the milk of lactating rats. Because of the potential for HIV transmission and the potential for serious adverse effects in nursing events regardless of relationship to study drug for Study ACTG 364. b SUSTIVA provided as 600 mg once daily. c Median infants, mothers should be instructed not to breast-feed if they are receiving SUSTIVA. duration of treatment. — = Not Specified. ZDV = zidovudine, LAM = lamivudine. Pediatric Use: ACTG 382 is an ongoing, open-label study in 57 NRTI-experienced pediatric patients to characterize the safety, pharmacokinetics, and antiviral activity of SUSTIVA in combination with nelfinavir (20-30 mg/kg TID) and NRTIs. Mean age was 8 years (range 3-16). Clinical adverse experiences observed in *10% of 57 pediatric patients aged 3 to 16 years who received SUSTIVA capsules, SUSTIVA has not been studied in pediatric patients below 3 years of age or who weigh less than 13 kg. At 48 weeks, the type and frequency nelfinavir, and one or more NRTIs were: rash (46%), diarrhea/loose stools (39%), fever (21%), cough (16%), of adverse experiences was generally similar to that of adult patients with the exception of a higher incidence of rash, which was reported dizziness/lightheaded/fainting (16%), ache/pain/discomfort (14%), nausea/vomiting (12%), and headache (11%). The incidence of in 46% (26/57) of pediatric patients compared to 26% of adults, and a higher frequency of Grade 3 or 4 rash reported in 5% (3/57) of nervous system symptoms was 18% (10/57). One patient experienced Grade 3 rash, two patients had Grade 4 rash, and five pediatric patients compared to 0.9% of adults (see ADVERSE REACTIONS, Percent of Patients with Treatment-Emergent Rash below). patients (9%) discontinued because of rash (see also PRECAUTIONS: Skin Rash and Pediatric Use). The starting dose of SUSTIVA was 600 mg once daily adjusted to body size, based on weight, targeting AUC levels in the range of Postmarketing Experience: Body as a Whole: allergic reactions, asthenia, redistribution/accumulation of body fat (see 190-380 μM•h. The pharmacokinetics of efavirenz in pediatric patients were similar to the pharmacokinetics in adults who received PRECAUTIONS: Fat Redistribution); Central and Peripheral Nervous System: abnormal coordination, ataxia, cerebellar coordination 600-mg daily doses of SUSTIVA. In 48 pediatric patients receiving the equivalent of a 600-mg dose of SUSTIVA, steady-state Cmax and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor; Endocrine: gynecomastia; Gastrointestinal: was 14.2 ± 5.8 μM (mean ± SD), steady-state Cmin was 5.6 ± 4.1 μM, and AUC was 218 ± 104 μM•h. constipation, malabsorption; Cardiovascular: flushing, palpitations; Liver and Biliary System: hepatic enzyme increase, hepatic Geriatric Use: Clinical studies of SUSTIVA did not include sufficient numbers of subjects aged 65 years and over to determine whether they failure, hepatitis; Metabolic and Nutritional: hypercholesterolemia, hypertriglyceridemia; Musculoskeletal: arthralgia, myalgia, respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater myopathy; Psychiatric: aggressive reactions, agitation, delusions, emotional lability, mania, neurosis, paranoia, psychosis, suicide; frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy. Respiratory: dyspnea; Skin and Appendages: erythema multiforme, nail disorders, photoallergic dermatitis, skin discoloration, ADVERSE REACTIONS Stevens-Johnson syndrome; Special Senses: abnormal vision, tinnitus The most significant adverse events observed in patients treated with SUSTIVA are nervous system symptoms, psychiatric symptoms, and Laboratory Abnormalities: Selected Grade 3-4 laboratory abnormalities reported in *2% of SUSTIVA-treated patients in two rash. Unless otherwise specified, the analyses described below included 1008 patients treated with regimens containing SUSTIVA and clinical trials are presented in Table 2 below. 635 patients treated with a control regimen in controlled trials. Nervous System Symptoms: Fifty-three percent of patients receiving SUSTIVA reported central nervous system symptoms (see Table 2: Selected Grade 3-4 Laboratory Abnormalities Reported in *2% of SUSTIVA-Treated Patients in WARNINGS: Nervous System Symptoms). The following paragraph lists the frequency of the symptoms of different degrees of severity Studies 006 and ACTG 364 and gives the discontinuation rates in clinical trials for one or more of the following nervous system symptoms: dizziness, insomnia, Study 006 Study ACTG 364 impaired concentration, somnolence, abnormal dreaming, euphoria, confusion, agitation, amnesia, hallucinations, stupor, abnormal LAM-, NNRTI-, and NRTI-experienced, NNRTI- and thinking, and depersonalization. The frequencies of specific central and peripheral nervous system symptoms areFull provided in Table page 1. Ad Protease Inhibitor-Naive Patients Protease Inhibitor-Naive Patients Percent of Patients with One or More Selected Nervous System Symptoms (regardless of causality) in Study 006 and Three SUSTIVAa SUSTIVAa Indinavir SUSTIVAa SUSTIVAa Nelfinavir Phase 2/3 Studies: SUSTIVA 600 mg Once Daily (n=1008), Control Groups (n=635), respectively: Symptoms of any severity (52.7%, † † † + ZDV/LAM + Indinavir + ZDV/LAM + Nelfinavir + NRTIs + NRTIs + NRTIs 24.6%); mild symptoms (33.3%, 15.6%); moderate symptoms (17.4%, 7.7%); severe symptoms (2.0%, 1.3%); treatment (n=412) (n=415) (n=401) (n=64) (n=65) (n=66) discontinuation as a result of symptoms (2.1%, 1.1%). b b b b b b †“Mild” = symptoms which do not interfere with patient’s daily activities,“moderate” = symptoms which may interfere 8”with daily actxivities, 10Variable 1/2” Limit 180 weeks 102 weeks 76 weeks 71.1 weeks 70.9 weeks 62.7 weeks “severe” = events which interrupt patient’s usual daily activities Chemistry Psychiatric Symptoms: Serious psychiatric adverse experiences have been reported in patients treated with SUSTIVA. In controlled trials, ALT >5 x ULN 5% 8% 5% 2% 6% 3% the frequency of specific serious psychiatric symptoms among patients who received SUSTIVA or control regimens, respectively, were AST >5 x ULN 5% 6% 5% 6% 8% 8% severe depression (2.4%, 0.9%), suicidal ideation (0.7%, 0.3%), nonfatal suicide attempts (0.5%, 0%), aggressive behavior (0.4%, 0.5%), GGTc >5 x ULN 8% 7% 3% 5% 0 5% paranoid reactions (0.4%, 0.3%), and manic reactions (0.2%, 0.3%) (see WARNINGS: Psychiatric Symptoms). Additional psychiatric Amylase >2 x ULN 4% 4% 1% 0 6% 2% symptoms observed at a frequency of >2% among patients treated with SUSTIVA or control regimens, respectively, in controlledPage clinical Glucose23 >250 mg/dL3% 3% 3% 5% 2% 3% trials were depression (19%, 16%), anxiety (13%, 9%), and nervousness (7%, 2%). Triglyceridesd *751 mg/dL 9% 6% 6% 11% 8% 17% Skin Rash: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 2 weeks of initiating Hematology therapy with SUSTIVA. In most patients, rash resolves with continuing SUSTIVA therapy within one month. SUSTIVA can be reinitiated Neutrophils <750/mm3 10% 3% 5% 2% 3% 2% in patients interrupting therapy because of rash. Use of appropriate antihistamines and/or corticosteroids may be considered when a SUSTIVA provided as 600 mg once daily. b Median duration of treatment. c Isolated elevations of GGT in SUSTIVA is restarted. SUSTIVA should be discontinued in patients developing severe rash associated with blistering, desquamation, patients receiving SUSTIVA may reflect enzyme induction not associated with liver toxicity. d Nonfasting. mucosal involvement, or fever. The frequency of rash by NCI grade and the discontinuation rates as a result of rash are provided in ZDV = zidovudine, LAM = lamivudine, ULN = Upper limit of normal, ALT = alanine aminotransferase, the following paragraph. Percent of Patients with Treatment-Emergent Rash (regardless of causality) in Study 006 and Three Phase 2/3 Studies: AST = aspartate aminotransferase, GGT = gamma-glutamyltransferase. SUSTIVA 600 mg Once Daily Adults (n=1008), SUSTIVA Pediatric Patients (n=57), Control Groups Adults (n=635), respectively: Rash ‡ Liver function tests should be monitored in patients with a history of hepatitis B and/or C. In the long-term data set from of any grade (26.3%, 45.6%, 17.5%), Grade 1 rash – erythema, pruritus (10.7%, 8.8%, 9.8%), Grade 2 rash – diffuse maculopapular Study 006, 137 patients treated with SUSTIVA-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a rash, dry desquamation (14.7%, 31.6%, 7.4%), Grade 3 rash – vesiculation, moist desquamation, ulceration (0.8%, 1.8%, 0.3%), control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C Grade 4 rash – erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative (hepatitis C antibody positive). Among these co-infected patients, elevations in AST to greater than five times ULN developed in 13% dermatitis (0.1%, 3.5%, 0.0%), Treatment discontinuation as a result of rash (1.7%, 8.8%, 0.3%). ‡NCI Grading System of patients in the SUSTIVA arms and 7% of those in the control arm, and elevations in ALT to greater than five times ULN developed As seen above, rash is more common in pediatric patients and more often of higher grade (ie, more severe) (see PRECAUTIONS: in 20% of patients in the SUSTIVA arms and 7% of patients in the control arm. Among co-infected patients, 3% of those treated General). with SUSTIVA-containing regimens and 2% in the control arm discontinued from the study because of liver or biliary system Experience with SUSTIVA in patients who discontinued other antiretroviral agents of the NNRTI class is limited. Nineteen patients who disorders (see PRECAUTIONS: General). discontinued nevirapine because of rash have been treated with SUSTIVA. Nine of these patients developed mild-to-moderate rash while Lipids: Increases from baseline in total cholesterol of 10-20% have been observed in some uninfected volunteers receiving receiving therapy with SUSTIVA, and two of these patients discontinued because of rash. SUSTIVA. In patients treated with SUSTIVA + zidovudine + lamivudine, increases from baseline in nonfasting total cholesterol and Pancreatitis has been reported, although a causal relationship with efavirenz has not been established. Asymptomatic increases in HDL of approximately 20% and 25%, respectively, were observed. In patients treated with SUSTIVA + indinavir, increases from serum amylase levels were observed in a significantly higher number of patients treated with efavirenz 600 mg than in control patients baseline in nonfasting cholesterol and HDL of approximately 40% and 35%, respectively, were observed. Nonfasting total (see ADVERSE REACTIONS: Laboratory Abnormalities). cholesterol levels *240 mg/dL and *300 mg/dL were reported in 34% and 9%, respectively, of patients treated with SUSTIVA + Selected clinical adverse experiences of moderate or severe intensity observed in *2% of SUSTIVA-treated patients in two controlled zidovudine + lamivudine; 54% and 20%, respectively, of patients treated with SUSTIVA + indinavir; and 28% and 4%, respectively, clinical trials are presented in Table 1 below. of patients treated with indinavir + zidovudine + lamivudine. The effects of SUSTIVA on triglycerides and LDL were not well characterized since samples were taken from nonfasting patients. The clinical significance of these findings is unknown (see PRECAUTIONS: General). Table 1: Selected Treatment-Emergenta Adverse Events of Moderate or Severe Intensity Reported in *2% of Cannabinoid Test Interaction: Efavirenz does not bind to cannabinoid receptors. False-positive urine cannabinoid test results have SUSTIVA-Treated Patients in Studies 006 and ACTG 364 been observed in non-HIV-infected volunteers receiving SUSTIVA when the Microgenics CEDIA® DAU Multi-Level THC assay was Study 006: LAM-, NNRTI-, and Study ACTG 364: NRTI-experienced, used for screening. Negative results were obtained when more specific confirmatory testing was performed with gas Protease Inhibitor-Naive Patients NNRTI- and Protease Inhibitor-Naive Patients chromatography/mass spectrometry. b b b b Of the three assays analyzed (Microgenics CEDIA DAU Multi-Level THC assay, Cannabinoid Enzyme Immunoassay [Diagnostic SUSTIVA SUSTIVA Indinavir SUSTIVA SUSTIVA Nelfinavir Reagents, Inc.], and AxSYM® Cannabinoid Assay), only the Microgenics CEDIA DAU Multi-Level THC assay showed false-positive + ZDV/LAM + Indinavir + ZDV/LAM + Nelfinavir + NRTIs + NRTIs + NRTIs results.The other two assays provided true-negative results.The effects of SUSTIVA on cannabinoid screening tests other than these (n=412) (n=415) (n=401) (n=64) (n=65) (n=66) c c c c c c three are unknown. The manufacturers of cannabinoid assays should be contacted for additional information regarding the use of Adverse Events 180 weeks 102 weeks 76 weeks 71.1 weeks 70.9 weeks 62.7 weeks their assays with patients receiving efavirenz. Body as a Whole OVERDOSAGE Fatigue 8% 5% 9% 0 2% 3% Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced Pain 1% 2% 8% 13% 6% 17% involuntary muscle contractions. Central and Peripheral Nervous System Treatment of overdose with SUSTIVA should consist of general supportive measures, including monitoring of vital signs and Dizziness 9% 9% 2% 2% 6% 6% observation of the patient’s clinical status. Administration of activated charcoal may be used to aid removal of unabsorbed drug. Headache 8% 5% 3% 5% 2% 3% There is no specific antidote for overdose with SUSTIVA. Since efavirenz is highly protein bound, dialysis is unlikely to significantly Insomnia 7% 7% 2% 0 0 2% remove the drug from blood. Concentration impaired 5% 3% <1% 0 0 0 Distributed by: Abnormal dreams 3% 1% 0 — — — Somnolence 2% 2% <1% 0 0 0 Anorexia 1% <1% <1% 0 2% 2% SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma Company. ATRIPLA is a trademark of Bristol-Myers Squibb & a Includes adverse events at least possibly related to study drug or of unknown relationship for Study 006. Includes all adverse Gilead Sciences, LLC. Other brands listed are the trademarks of their respective owners. b c events regardless of relationship to study drug for Study ACTG 364. SUSTIVA provided as 600 mg once daily. Median © Bristol-Myers Squibb Company 2008 Printed in USA duration of treatment. — = Not Specified. ZDV = zidovudine, LAM = lamivudine. (continued) 1212823A2 692US08PBS00301 T4-B0001A-03-08 Rev March 2008 (continued)Legal Affairs (continued from page 8)

Boyett himself. Dr. Lovell’s expert report stated, “The findings of the autopsy. Those findings were: (1) mul- severe wound on posterior scalp is in such a position tiple cutaneous contusions and abrasions, including that it was more likely than not caused by an external forehead, left hand, right foreleg, right and left foot; blow rather than a fall.” ... Dr. Lovell also stated the lin- (2) multiple rib fractures (L 8, 9, 10, 11), lacerations ear tear in Boyett’s anus “was undoubtedly penetration (parietal pleura), and intercostal hematomas; (3) lac- with a blunt foreign body.” ... Nevertheless, Dr. Lovell eration (anus); (4) multiple scalp contusions; (5) coro- ultimately agreed with the medical examiner that nary artery atherosclerosis-stenosis; (6) cirrhosis of the Boyett died of “cardiac arrest.” liver; (7) pulmonary emphysema; and (8) hematoma A former state medical examiner, Dr. Graham, (omentum).... According to Plaintiffs, the conclusion performed an autopsy on Boyett’s body more than that Washington County officials inflicted serious and one month after Dr. Leis’s official autopsy had been deadly injury upon Boyett flows inescapably from completed. Dr. Graham’s autopsy report contained the medical observations of these three experts. We an “anatomical summary” listing the most important disagree.

The problem, of course, is not the description of injuries or even linking these presumably humanly inflicted injuries to heart failure; it is the inability to show a perpetrator. “That which is done in silence and in the dark cannot be undone nor the lethal hand exposed.” Subscribe Today The panel concluded that none of these experts can link either the supposed mechanism or perpetrator to Boyett’s injuries. The plaintiffs, rather ingeniously, invoke the legal decline of res ipsa loquitor: the thing speaks for itself. The sponges left in the chest cavity after surgery is a prime EditorE example of negligence on its face. The court didn’t reject JohnJ R. Miles, MPA this proof theory, noting only that the most it can prove is negligence. The case requires “malicious and sadistic” use of force or deliberate indifference as to medical care. Municipal Liability Failing to prevail on individual liability, plaintiffs then sought to hold the municipality liable. There is no vicarious liability under Section 1983, so the plaintiffs’ burden was to show an unconstitutional policy, practice or failure to train. That is, the municipality must be directly linked to the conduct The Ofﬁ cial Journal of the that caused the harm. National Commission on However, the plaintiffs showed no such policy or prac- Correctional Health Care tice. Pointing to the practice of injecting Thorazine in unknown amounts and frequency without records and based on “standing orders” failed because Boyett died from trauma or a heart attack unrelated to the Thorazine claims. Conclusion Visit JCHC’s website at As I noted earlier, this is an extremely troubling case and an unsatisfactory outcome. Mental illness combined with http://jchc.sagepub.com physical ailments and unexplained trauma (the rectum tear!) leading to death—but no liability. The perfect crime? • Subscribe online Maybe. • Recommend to your librarian • Access a free sample issue online Fred Cohen, LLM, is the editor of the Correctional Mental • Experience SAGE Journals Online Health Report. This is an abridged version of an article from Vol. 10, Issue 4, November/December, of the report, powerful reference linking © 2008 Civic Research Institute, Inc. It is reprinted here with permission of the publisher. All rights reserved. For subscription information, contact Civic Research Institute, 4478 U.S. Route 27, P.O. Box 585, Kingston, NJ 08528; 609-683-4450; www.civicresearchinstitute.com.

24 HJ08040450_1088084_JCHC_Ad_4.5x7.inddSummer 2008 •1 CorrectCare 4/17/2008 11:22:58 AM www.ncchc.org

40438_AT-222_15052_Correct_Ad 1 7/17/08 10:55:01 AM TRUVADA is a once a day backbone for combination therapy in adults with HIV-1. Treat HIV confidently # correctional 1 in 1 prescribed facilities with TRUVADA in NRTI backbone correctional facilities

■ Demonstrated efficacy and tolerability through 3 years in Studies 934 and 903*2,3

■ TRUVADA or its components have been DHHS preferred since 20044

■ TRUVADA or its components have been partnered in long-term clinical trials with leading PIs1,5-9 ■ Reyataz® (atazanavir sulfate) ■ PrezistaTM (darunavir) ■ Kaletra® (lopinavir/ritonavir) ■ Lexiva® (fosamprenavir calcium)

® Depend on TRUVADAFull page to Ad be your partner with PIs emtricitabine • tenofovir disoproxil fumarate 8” x 10 1/2” Drug interactions have been observed between tenofovir DF and atazanavir or lopinavir/ritonavir. Atazanavir 300 mg should be boosted with ritonavir 100 mg and taken with food when administered with TRUVADA. Atazanavir without ritonavir should not be coadministered with TRUVADA. Patients on atazanavir or lopinavir/ritonavir plus TRUVADA should be monitored for TRUVADA-associated adverse reactions. TRUVADA shouldPage be discontinued 25 in patients who develop TRUVADA-associated adverse reactions.2

Indication and Usage2 ■ Assess creatinine clearance (CrCl) before initiating treatment with ■ Lopinavir/ritonavir (LPV/r): Coadministration increases tenofovir concentrations. TRUVADA, a combination of EMTRIVA® (emtricitabine [FTC]) and VIREAD® (tenofovir TRUVADA. Routinely monitor CrCl and serum phosphorus in patients at risk Monitor for evidence of TRUVADA-associated adverse reactions ■ disoproxil fumarate [TDF]), is indicated in combination with other antiretroviral No dose adjustment is necessary for patients with mild renal impairment Adverse Reactions agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) (CrCl 50–80 mL/min) ■ ≥ for the treatment of HIV-1 infection in adults. Additional important information The most common (incidence 10%, any severity) and/or treatment- ■ ≥ regarding the use of TRUVADA for the treatment of HIV-1 infection: Dosing interval adjustment of TRUVADA and close monitoring of renal emergent (Grade 2–4, occurring in 5% of patients) adverse reactions occurring in Study 934 through 144 weeks include diarrhea, nausea, ■ function are recommended in all patients with CrCl 30–49 mL/min. No It is not recommended that TRUVADA be used as a component of a triple safety or efficacy data are available in patients with renal impairment fatigue, sinusitis, upper respiratory tract infections, nasopharyngitis, headache, nucleoside regimen who received TRUVADA using these dosing guidelines, so the potential dizziness, depression, insomnia, abnormal dreams, and rash ■ ® TRUVADA should not be coadministered with ATRIPLA (efavirenz [EFV] benefit of TRUVADA therapy should be assessed against the potential ■ Other adverse reactions that occurred in at least 5% of patients receiving 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), risk of renal toxicity. TRUVADA should not be administered to patients EMTRIVA or VIREAD with other antiretroviral agents in clinical trials include † EMTRIVA, VIREAD, or lamivudine-containing products with CrCl <30 mL/min or patients requiring hemodialysis anxiety, arthralgia, increased cough, dyspepsia, fever, myalgia, pain, abdominal ■ In treatment-experienced patients, the use of TRUVADA should be guided by ■ Avoid administering TRUVADA with concurrent or recent use of pain, back pain, paresthesia, peripheral neuropathy (including peripheral neuritis laboratory testing and treatment history nephrotoxic drugs and neuropathy), pneumonia, and rhinitis ■ *In clinical Study 303, EMTRIVA and lamivudine (3TC) demonstrated comparable efficacy, safety, and WARNINGS Coadministration of TRUVADA with drugs that are eliminated by resistance profiles as part of multidrug regimens, which supports the extrapolation of 3TC data to FTC.2 Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, active tubular secretion may increase concentrations of emtricitabine, ______have been reported with the use of nucleoside analogs alone or in combination tenofovir, and/or the coadministered drug. Drugs that decrease renal † Combivir® (zidovudine/lamivudine), Epivir® (lamivudine) or Epivir HBV® (lamivudine), Epzicom® with other antiretrovirals. function may increase concentrations of emtricitabine and/or tenofovir (abacavir sulfate/lamivudine), and Trizivir® (abacavir sulfate/lamivudine/zidovudine). TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) ■ Decreases in bone mineral density (BMD): Consider monitoring BMD in patients References: 1. Derived from patient chart audit, Synovate Healthcare Data, US HIV Monitor, 2007 Q4. infection, and the safety and efficacy of TRUVADA have not been established in 2. TRUVADA® (emtricitabine/tenofovir disoproxil fumarate) Prescribing Information. Gilead Sciences, with a history of pathologic fracture or who are at risk for osteopenia ® patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis Inc. May 2008. 3. VIREAD (tenofovir disoproxil fumarate) Prescribing Information. Gilead Sciences, Inc. ■ Redistribution/accumulation of body fat: Observed in patients receiving May 2008. 4. US Dept of Health and Human Services, Panel on Clinical Practices for Treatment B have been reported in patients who are coinfected with HBV and HIV-1 and of HIV Infection. Guidelines for the use of antiretroviral agents on HIV-infected adults and adolescents. have discontinued EMTRIVA or VIREAD, the components of TRUVADA. Hepatic antiretroviral therapy October 29, 2004–January 29, 2008. Available at: http://www.aidsinfo.nih.gov/guidelines/ function should be monitored closely with both clinical and laboratory follow-up ■ Immune reconstitution syndrome: May necessitate further evaluation and ArchivedGuidelines.aspx?MenuItem=Guidelines=Search+Off&GuidelineID=18&ClassID=6. Accessed May 27, 2008. 5. Johnson M, Grinszstejn B, Rodriguez C, et al. 96-week comparison of once-daily atazanavir/ for at least several months in patients who are coinfected with HIV-1 and HBV treatment ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS. and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy 2006;20:711-718. 6. Riddler SA, Haubrich R, DiRienzo AG, et al, for the AIDS Clinical Trials Group may be warranted. Drug Interactions Study A5142 Team. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med. ■ Didanosine (ddI): Tenofovir disoproxil fumarate increases ddI concentrations. 2008;358:2095-2106. 7. Molina J-M, Podsadecki TJ, Johnson MA, et al. A lopinavir/ritonavir-based Warnings and Precautions once-daily regimen results in better compliance and is non-inferior to a twice-daily regimen through Consider dose reductions or discontinuations of ddI if warranted 96 weeks. AIDS Res Hum Retroviruses. 2007;23:1505-1514. 8. US National Institutes of Health, ■ New Onset or Worsening Renal Impairment: ■ Atazanavir (ATV): Coadministration decreases ATV concentrations and Clinicaltrials.gov Web site. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00258557? ■ term=tibotec+cr002800&rank=1. Accessed May, 27 2008. 9. US National Institutes of Health, Emtricitabine and tenofovir are principally eliminated by the kidney. increases tenofovir concentrations. Use ATV with TRUVADA only with Clinicaltrials.gov Web site. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00242216? Renal impairment can include acute renal failure and Fanconi syndrome ritonavir; monitor for evidence of TRUVADA-associated adverse reactions term =PIQD&rank=1. Accessed May, 27 2008.

Please see brief summary of full Prescribing Information on following page, including boxed WARNING information about lactic acidosis, severe hepatomegaly with steatosis, and exacerbations of hepatitis B upon discontinuation of therapy.2 ©2008 Gilead Sciences, Inc. All rights reserved. QD0727 07/08

40438_AT-222_15052_Correct_Ad 1 7/17/08 10:55:01 AM The following is a brief summary for TRUVADA® (emtricitabine/tenofovir Tenofovir Disoproxil Fumarate: In a 144-week study of treatment naïve patients, USE IN SPECIFIC POPULATIONS disoproxil fumarate [DF]) tablets. Before prescribing, see full Prescribing decreases in bone mineral density (BMD) were seen at the lumbar spine and hip in Pregnancy Category B: Emtricitabine: The incidence of fetal variations and Information, including boxed WARNINGS. both arms of the study. At Week 144, there was a significantly greater mean percentage malformations was not increased in embryofetal toxicity studies performed with decrease from baseline in BMD at the lumbar spine in patients receiving VIREAD + emtricitabine in mice at exposures (AUC) approximately 60-fold higher and in rabbits at WARNINGS: LACTIC ACIDOSIS, SEVERE HEPATOMEGALY WITH lamivudine (3TC) + efavirenz (EFV) compared with patients receiving stavudine + approximately 120-fold higher than human exposures at the recommended daily dose. STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF lamivudine + efavirenz. Changes in BMD at the hip were similar between the two Tenofovir Disoproxil Fumarate: Reproduction studies have been performed in HEPATITIS B. treatment groups. In both groups, the majority of the reduction in BMD occurred in the rats and rabbits at doses up to 14 and 19 times the human dose based on body surface Lactic acidosis and severe hepatomegaly with steatosis, including first 24–48 weeks of the study and this reduction was sustained through 144 weeks. area comparisons and revealed no evidence of impaired fertility or harm to the fetus fatal cases, have been reported with the use of nucleoside analogs Twenty-eight percent of VIREAD-treated patients vs. 21% of the comparator patients due to tenofovir. alone or in combination with other antiretrovirals [See Warnings lost at least 5% of BMD at the spine or 7% of BMD at the hip. Clinically relevant There are, however, no adequate and well-controlled studies in pregnant women. Because and Precautions]. fractures (excluding fingers and toes) were reported in 4 patients in the VIREAD group animal reproduction studies are not always predictive of human response, TRUVADA TRUVADA is not approved for the treatment of chronic hepatitis B virus and 6 patients in the comparator group. Tenofovir disoproxil fumarate was associated should be used during pregnancy only if clearly needed. (HBV) infection and the safety and efficacy of TRUVADA have not been with significant increases in biochemical markers of bone metabolism (serum bone- Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women established in patients coinfected with HBV and HIV-1. Severe acute specific alkaline phosphatase, serum osteocalcin, serum C-telopeptide, and urinary exposed to TRUVADA (emtricitabine/tenofovir disoproxil fumarate), an Antiretroviral exacerbations of hepatitis B have been reported in patients who are N-telopeptide), suggesting increased bone turnover. Serum parathyroid hormone levels Pregnancy Registry has been established. Healthcare providers are encouraged to coinfected with HBV and HIV-1 and have discontinued EMTRIVA or and 1,25 Vitamin D levels were also higher in patients receiving VIREAD. The effects of register patients by calling 1-800-258-4263. VIREAD-associated changes in BMD and biochemical markers on long-term bone VIREAD, the components of TRUVADA. Hepatic function should be Nursing Mothers: The Centers for Disease Control and Prevention monitored closely with both clinical and laboratory follow-up for at health and future fracture risk are unknown. For additional information, please consult the VIREAD prescribing information. recommend that HIV-1-infected mothers not breast-feed their infants to least several months in patients who are coinfected with HIV-1 and HBV avoid risking postnatal transmission of HIV-1. Studies in rats have and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B Cases of osteomalacia (associated with proximal renal tubulopathy) have been reported in association with the use of VIREAD demonstrated that tenofovir is secreted in milk. It is not known whether tenofovir is therapy may be warranted [See Warnings and Precautions]. [See Adverse Reactions]. excreted in human milk. It is not known whether emtricitabine is excreted in human Fat Redistribution: Redistribution/accumulation of body fat including central milk. Because of both the potential for HIV-1 transmission and the potential for serious INDICATIONS AND USAGE obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial ® ® adverse reactions in nursing infants, mothers should be instructed not to TRUVADA, a combination of EMTRIVA (emtricitabine) and VIREAD (tenofovir wasting, breast enlargement, and “cushingoid appearance” have been observed in disoproxil fumarate), is indicated in combination with other antiretroviral agents breast-feed if they are receiving TRUVADA. patients receiving antiretroviral therapy. The mechanism and long-term consequences Pediatric Use: TRUVADA is not recommended for patients less than 18 years of (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the of these events are currently unknown. A causal relationship has not been established. treatment of HIV-1 infection in adults. age because it is a fixed-dose combination tablet containing a component, VIREAD, Immune Reconstitution Syndrome: Immune reconstitution syndrome has been for which safety and efficacy have not been established in this age group. Additional important information regarding the use of TRUVADA for the treatment reported in patients treated with combination antiretroviral therapy, including EMTRIVA of HIV-1 infection: Geriatric Use: Clinical studies of EMTRIVA or VIREAD did not include sufficient and VIREAD. During the initial phase of combination antiretroviral treatment, patients numbers of subjects aged 65 and over to determine whether they respond differently from •It is not recommended that TRUVADA be used as a component of a triple whose immune system responds may develop an inflammatory response to indolent nucleoside regimen. younger subjects. In general, dose selection for the elderly patients should be cautious, ® or residual opportunistic infections [such as Mycobacterium avium infection, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, •TRUVADA should not be coadministered with ATRIPLA (efavirenz 600mg/ cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis], which may and of concomitant disease or other drug therapy. emtricitabine 200mg/tenofovir disoproxil fumarate 300mg), EMTRIVA, VIREAD, necessitate further evaluation and treatment. or lamivudine-containing products [See Warnings and Precautions]. Patients with Impaired Renal Function: It is recommended that the dosing ADVERSE REACTIONS interval for TRUVADA be modified in patients with creatinine clearance 30–49 mL/min. •In treatment experienced patients, the use of TRUVADA should be guided by laboratory Adverse Reactions from Clinical Trials Experience: Because clinical trials TRUVADA should not be used in patients with creatinine clearance <30 mL/min and in testing and treatment history. are conducted under widely varying conditions, adverse reaction rates observed in the patients with end-stage renal disease requiring dialysis [See Dosage and Administration]. DOSAGE AND ADMINISTRATION clinical trials of a drug cannot be directly compared to rates in the clinical trials NONCLINICAL TOXICOLOGY The dose of TRUVADA is one tablet (containing 200 mg of emtricitabine and 300 mg of of another drug and may not reflect the rates observed in practice. Carcinogenesis, Mutagenesis, Impairment of Fertility tenofovir disoproxil fumarate) once daily taken orally with or without food. The most common adverse reactions (incidence ≥10%, any severity) occurring in Emtricitabine: In long-term oral carcinogenicity studies of emtricitabine, no drug- Dose Adjustment for Renal Impairment: Significantly increased drug exposures Study 934, an active-controlled clinical study of efavirenz, emtricitabine, and tenofovir related increases in tumor incidence were found in mice at doses up to 750 mg/kg/day occurred when EMTRIVA or VIREAD were administered to patients with moderate to disoproxil fumarate, include diarrhea, nausea, fatigue, headache, dizziness, (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in severe renal impairment [See EMTRIVA or VIREAD Package Insert]. Therefore, the depression, insomnia, abnormal dreams, and rash. See also full Prescribing rats at doses up to 600 mg/kg/day (31 times the human systemic exposure at the dosing interval of TRUVADA should be adjusted in patients with baseline creatinine Information for the frequency of treatment-emergent adverse reactions (Grade 2–4) therapeutic dose). clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval occurring in ≥5% of patients treated with efavirenz, emtricitabine, and tenofovir Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test), mouse recommendations are based on modeling of single-dose pharmacokinetic data in non- disoproxil fumarate in this study. lymphoma or mouse micronucleus assays. HIV-1 infected subjects. The safety and effectiveness of these dosing interval adjustment Skin discoloration, manifested by hyperpigmentation on the palms and/or soles was Emtricitabine did not affect fertility in male rats at approximately 140-fold or in recommendations have not been clinically evaluated in patients with moderate renal generally mild and asymptomatic. The mechanism and clinical significance are unknown. male and female mice at approximately 60-fold higher exposures (AUC) than in impairment, therefore, clinical response to treatment and renal function should be closely Study 934 - Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviral- humans given the recommended 200 mg daily dose. Fertility was normal in the monitored in these patients [See Warnings and Precautions]. naïve patients received either VIREAD + EMTRIVA administered in combination with offspring of mice exposed daily from before birth (in utero) through sexual maturity No dose adjustment is necessary for patients with mild renal impairment (creatinine efavirenz (N=257) or zidovudine/lamivudine administered in combination with at daily exposures (AUC) of approximately 60-fold higher than human exposures at clearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serum efavirenz (N=254). Adverse reactions observed in this study were generally consistent the recommended 200 mg daily dose. phosphorus should be performed in patients [See Warnings and Precautions]. with those seen in other studies in treatment-experienced or treatment-naïve patients Tenofovir Disoproxil Fumarate: Long-term oral carcinogenicity studies of Table 1. receiving VIREAD and/or EMTRIVA, including diarrhea, nausea, vomiting, fatigue, tenofovir disoproxil fumarate in mice and rats were carried out at exposures up to Dosage Adjustment for Patients with Altered Creatinine Clearance sinusitis, upper respiratory tract infections, nasopharyngitis, headache, dizziness, approximately 16 times (mice) and 5 times (rats) those observed in humans at the depression, insomnia, and rash event. therapeutic dose for HIV-1 infection. At the high dose in female mice, liver Full page Ad adenomas were increased at exposures 16 times that in humans. In rats, the study Creatinine Clearance (mL/min)* Laboratory Abnormalities: Laboratory abnormalities observed in this study were generally consistent with those seen in other studies of VIREAD and/or EMTRIVA. was negative for carcinogenic findings at exposures up to 5 times that observed in ≥50 30–49 <30 (Including Patients humans at the therapeutic dose. Requiring Hemodialysis) Tenofovir disoproxil fumarate was mutagenic in the in vitro mouse lymphoma Recommended Every Every TRUVADA should assay and negative in an in vitro bacterial mutagenicity test (Ames test). In an in Dosing Interval 24 hours 48 hours not be administered. 8” x 10 1/2” vivo mouse micronucleus assay, tenofovir disoproxil fumarate was negative when ® administered to male mice. CONTRAINDICATIONS There were no effects on fertility, mating performance or early embryonic development TRUVADA is contraindicated in patients with previously demonstrated hypersensitivity when tenofovir disoproxil fumarate was administered to male rats at a dose equivalent to 10 times the human dose based on body surface area comparisons for 28 days to any of the components of the product. • emtricitabinePagetenofovir disoproxil 26 fumarate prior to mating and to female rats for 15 days prior to mating through day seven of WARNINGS AND PRECAUTIONS gestation. There was, however, an alteration of the estrous cycle in female rats. Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and Postmarketing Experience: The following adverse reactions have been identified PATIENT COUNSELING INFORMATION during postapproval use of VIREAD: allergic reaction, hypophosphatemia, lactic acidosis, severe hepatomegaly with steatosis, including fatal cases, have been reported with the Patients should be advised that: use of nucleoside analogs alone or in combination with other antiretrovirals. A majority dyspnea, abdominal pain, increased amylase, pancreatitis, increased liver enzymes (most commonly increased AST, ALT, Gamma GT), hepatitis, rash, myopathy, osteomalacia •TRUVADA is not a cure for HIV-1 infection and patients may continue to experience of these cases have been in women. Obesity and prolonged nucleoside exposure may illnesses associated with HIV-1 infection, including opportunistic infections. be risk factors. Particular caution should be exercised when administering nucleoside (both associated with proximal renal tubulopathy), renal insufficiency, renal failure, acute Patients should remain under the care of a physician when using TRUVADA. renal failure, Fanconi syndrome, proximal tubulopathy, proteinuria, increased creatinine, analogs to any patient with known risk factors for liver disease; however, cases have •The use of TRUVADA has not been shown to reduce the risk of transmission of HIV-1 also been reported in patients with no known risk factors. Treatment with TRUVADA acute tubular necrosis, nephrogenic diabetes insipidus, polyuria, interstitial nephritis to others through sexual contact or blood contamination. (including acute cases), and asthenia. Because postmarketing reactions are reported should be suspended in any patient who develops clinical or laboratory findings •The long term effects of TRUVADA are unknown. voluntarily from a population of uncertain size, it is not always possible to reliably suggestive of lactic acidosis or pronounced hepatotoxicity (which may include •TRUVADA tablets are for oral ingestion only. hepatomegaly and steatosis even in the absence of marked transaminase elevations). estimate their frequency or establish a causal relationship to drug exposure. DRUG INTERACTIONS •It is important to take TRUVADA with combination therapy on a regular dosing schedule Patients Coinfected with HIV-1 and HBV: It is recommended that all patients to avoid missing doses. with HIV-1 be tested for the presence of chronic HBV before initiating antiretroviral No drug interaction studies have been conducted using TRUVADA tablets. Drug •Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have therapy. TRUVADA is not approved for the treatment of chronic HBV infection and the interaction studies have been conducted with emtricitabine and tenofovir disoproxil been reported. Treatment with TRUVADA should be suspended in any patients who safety and efficacy of TRUVADA have not been established in patients coinfected with fumarate, the components of TRUVADA. This section describes clinically relevant drug develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity HBV and HIV-1. Severe acute exacerbations of Hepatitis B have been reported in interactions observed with emtricitabine and tenofovir disoproxil fumarate. (including nausea, vomiting, unusual or unexpected stomach discomfort, and patients who are coinfected with HBV and HIV-1 and have discontinued EMTRIVA or Didanosine: Coadministration of TRUVADA and didanosine should be weakness) [See Warnings and Precautions]. VIREAD. In some patients infected with HBV and treated with EMTRIVA, the undertaken with caution and patients receiving this combination •All patients with HIV-1 should be tested for HBV before initiating antiretroviral therapy. exacerbations of Hepatitis B were associated with liver decompensation and liver should be monitored closely for didanosine-associated adverse •Severe acute exacerbations of Hepatitis B have been reported in patients who are failure. Hepatic function should be monitored closely with both clinical and laboratory reactions. Didanosine should be discontinued in patients who develop coinfected with HBV and HIV-1 and have discontinued EMTRIVA or VIREAD. didanosine-associated adverse reactions. When tenofovir disoproxil follow up for at least several months in patients who are coinfected with •Renal impairment, including cases of acute renal failure and Fanconi syndrome, has HIV-1 and HBV and discontinue TRUVADA. If appropriate, initiation of anti-Hepatitis B fumarate was administered with didanosine the Cmax and AUC of didanosine administered as either the buffered or enteric-coated formulation increased significantly. The mechanism been reported in association with the use of VIREAD. TRUVADA should be avoided therapy may be warranted. with concurrent or recent use of a nephrotoxic agent [See Warnings and Precautions]. New Onset or Worsening Renal Impairment: Emtricitabine and tenofovir are of this interaction is unknown. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. Dosing interval of TRUVADA may need adjustment in patients with renal impairment principally eliminated by the kidney. Renal impairment, including cases of acute renal + [See Dosage and Administration]. failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), Suppression of CD4 cell counts has been observed in patients receiving tenofovir DF with didanosine 400 mg daily. In adults weighing >60 kg, the didanosine dose should be •TRUVADA should not be coadministered with ATRIPLA, EMTRIVA, or VIREAD; or has been reported with the use of VIREAD [See Adverse Reactions]. with drugs containing lamivudine, including Combivir, Epivir or Epivir-HBV, It is recommended that creatinine clearance be calculated in all patients prior to reduced to 250 mg when it is coadministered with TRUVADA. Data are not available to recommend a dose adjustment of didanosine for patients weighing <60 kg. When Epzicom, or Trizivir [See Warnings and Precautions]. initiating therapy and as clinically appropriate during therapy with TRUVADA. Routine •Decreases in bone mineral density have been observed with the use of VIREAD. Bone monitoring of calculated creatinine clearance and serum phosphorus should be coadministered, TRUVADA and Videx EC may be taken under fasted conditions or with a light meal (<400 kcal, 20% fat). Coadministration of didanosine buffered tablet monitoring should be considered in patients who have a history of pathologic bone performed in patients at risk for renal impairment. fracture or at risk for osteopenia [See Warnings and Precautions]. Dosing interval adjustment of TRUVADA and close monitoring of renal function are formulation with TRUVADA should be under fasted conditions. recommended in all patients with creatinine clearance 30–49 mL/min [See Dosage Atazanavir: Atazanavir has been shown to increase tenofovir concentrations. The and Administration]. No safety or efficacy data are available in patients with renal mechanism of this interaction is unknown. Patients receiving atazanavir and impairment who received TRUVADA using these dosing guidelines, so the potential TRUVADA should be monitored for TRUVADA-associated adverse benefit of TRUVADA therapy should be assessed against the potential risk of renal reactions. TRUVADA should be discontinued in patients who develop toxicity. TRUVADA should not be administered to patients with creatinine clearance TRUVADA-associated adverse reactions. Tenofovir decreases the AUC and <30 mL/min or patients requiring hemodialysis. Cmin of atazanavir. When coadministered with TRUVADA, it is recommended that TRUVADA should be avoided with concurrent or recent use of a nephrotoxic agent. atazanavir 300 mg is given with ritonavir 100 mg. Atazanavir without ritonavir Coadministration with Related Products: TRUVADA should not be should not be coadministered with TRUVADA. coadministered with ATRIPLA, EMTRIVA, or VIREAD. Due to similarities between Lopinavir/Ritonavir: Lopinavir/ritonavir has been shown to increase tenofovir emtricitabine and lamivudine, TRUVADA should not be coadministered with other concentrations. The mechanism of this interaction is unknown. Patients receiving drugs containing lamivudine, including Combivir® (zidovudine/lamivudine [AZT/3TC]), lopinavir/ritonavir and TRUVADA should be monitored for TRUVADA- Epivir® (lamivudine) or Epivir-HBV® (lamivudine), Epzicom® (abacavir sulfate/lamivudine), associated adverse reactions. TRUVADA should be discontinued in *Calculated using ideal (lean) body weight. or Trizivir® (abacavir sulfate/lamivudine/zidovudine). patients who develop TRUVADA-associated adverse reactions. Decreases in Bone Mineral Density: Bone mineral density monitoring should Drugs Affecting Renal Function: Because emtricitabine and tenofovir are primarily Gilead Sciences, Inc. Foster City, CA 94404 May 2008 be considered for HIV-1 infected patients who have a history of pathologic bone excreted by the kidneys, coadministration of TRUVADA with drugs that are eliminated by fracture or are at risk for osteopenia. Although the effect of supplementation with active tubular secretion may increase concentrations of emtricitabine, tenofovir, and/or TRUVADA, EMTRIVA, and VIREAD are trademarks of Gilead Sciences, Inc. calcium and vitamin D was not studied, such supplementation may be beneficial for the coadministered drug. Some examples include, but are not limited to acyclovir, ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All all patients. If bone abnormalities are suspected then appropriate consultation should adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, and valganciclovir. Drugs that other trademarks referenced herein are the property of their respective owners. be obtained. decrease renal function may increase concentrations of emtricitabine and/or tenofovir. ©2008 Gilead Sciences, Inc. All rights reserved. 05/08

40438_AT-222_15052_Correct_PI 1 7/17/08 11:04:50 AM CME Opportunity Improving Therapeutic Outcomes in HIV Patients

NCCHC is supporting a collaborative educational effort that • Discuss drug selection and patient education strategies aims to improve health outcomes of HIV patients in correc- to overcome unrealistic therapeutic options in correctional tional settings. The program is chaired by John Bartlett, MD, systems and to improve adherence among inmates professor of medicine, director of the infectious diseases • Explain strategies to bridge the gap with community- division and director of the AIDS service at Johns Hopkins based HIV providers to maintain continuity of care received University School of Medicine. Faculty members include while in prison Bartlett, Rick Altice, David Wohl and Judith Feinberg. • Apply effective communication skills with multidisci- The program is accredited by the JHU School of plinary care providers and officers within the correctional Medicine, Office of CME in cooperation with NCCHC; setting to ensure appropriate diagnosis, minimize therapeu- 5.75 AMA PRA Category 1 Credits™ are available. It is being tic interruption and increase adherence implemented in cooperation with MedXcel, LLC, and MedCases, and was funded through an educational grant from Boehringer Ingelheim Pharmaceuticals. To learn more, visit www.correctionscme.com. Program Overview • Target audience: This course is designed for physicians, physician assistants, nurses and nurse practitioners involved in the treatment of HIV/AIDS in correctional systems. • Live meeting format: Didactic clinical presentations will begin at 9 a.m., followed by a workshop for participants that will include interactive, peer-to-peer discussions on patient cases. Additional presentations will follow a lunch break, and the course will conclude at 4:30 p.m. Attendees will receive a “Winning Behaviors™” patient education tool for use in their practice. • Enduring materials: Accredited online interactive case- based simulations and a monograph will be available to attendees as well as other clinicians who could not attend. Activity Objectives At the conclusion of this activity, participants should be able to: • Identify factors that influence the evolution of drug- resistant HIV-1 variants and explain how resistance muta- tions are generated or avoided, and how they can be con- ferred to others • Describe the advantages and disadvantages of phenotypic, genotypic and virtual phenotypic assays for antiretroviral (ARV) resistance mutational identification when selecting appropriate regimens for naïve, as well as highly- experienced, patients • Appraise the latest efficacy, safety and pharmacokinetic data of approved and investigational ARV agents (including the two new drug classes: integrase inhibitors and CCR5 antagonists) • Assess the options for HAART in HIV patients with cardiovascular disease or other cardiometabolic risk factors such as diabetes and hypertension At Wexford Health, we take our responsibilities seriously. That’s why MEDICAL • Describe pharmacologic and clinical significance of we have been a trusted partner to more than 250 correctional facilities MENTAL HEALTH drug-drug interactions in HIV-infected patients with comor- across the country, helping them to control costs without sacrificing DENTAL quality of care, cutting corners, or inappropriately denying services. PHARMACY bidities that require statins, azoles, anti-TB drugs and others The pride we take in meeting your needs is plain to see. STAFFING • Recognize the relevance of mental health disorders and EMR UTILIZATION MANAGEMENT their treatment between male and female incarcerated HIV 412-937-8590 CLAIMS PROCESSING patients when initiating on HAART [email protected] TELEMEDICINE

27 www.ncchc.org Summer 2008 • CorrectCare voice

n this column, we talk with Geraldine Pearson, PhD, lap. HomeCare’s patients also can use the FQHCs’ primary APRN, director of an innovative program created to care and dental services. So everyone wins. Iensure that the psychotropic medication needs for youth in Connecticut’s juvenile justice system are met as JR: How are children referred to HomeCare and how long the youth transition back to the community. do they stay with you? GP: At first, referrals came only from juvenile proba- JR: Finding aftercare for detainees on psychotropic medi- tion officers, and they still make up most referrals. There cations is a concern in almost every jurisdiction. Can you is a great benefit in the partnership formed between tell us how HomeCare started? HomeCare and juvenile probation as we work together to GP: In spring 2003, the University of Connecticut Health manage complicated clients. Center’s department of psychiatry received a grant from Now, referrals also come from adult probation officers the state. The HomeCare program was born out of that who oversee offenders under age 18, from DCF workers and grant with the goal of developing outpatient child/adoles- from licensed clinical coordinators, who recently have been cent psychiatry services in Connecticut’s federally qualified added to several probation offices in Connecticut. health clinics (FQHCs). These clinics would serve young- The average length of involvement in HomeCare is about sters needing short-term medication management after three months. The goal is always referral to a longer term leaving a juvenile detention center. In that way, HomeCare provider and no one is discharged until that link occurs. would be an essential bridge for children awaiting appoint- Some youngsters do return to the program, including after ments with longer term providers. re-arrest or residential placement, even years later. Before joining HomeCare, I was a clinical nurse specialist in the children’s state psychiatric hospital and had just JR: Do you have any outcome data regarding your pro- completed my PhD in nursing. I was drawn to HomeCare gram’s efforts to bridge care? because of the challenge of developing a community-based GP: An institutional review board-approved study is system for our high-need juvenile justice population. now analyzing the re-arrest pattern for youth who received a HomeCare intake versus children who did not follow JR: How is your program staffed and organized? through with the intake referral. The study is in process so GP: HomeCare operates with a renewable $404,000 grant results are pending. from the State of Connecticut Department of Children and Families and the Judicial Branch, Court Support Services JR: What advice would you give to professionals consider- Division. The program has expanded over the last five ing a program like HomeCare? years, with increasing hours in each FQHC. The FQHC bills GP: They should feel free to contact me. We are prepar- Medicaid for HomeCare services. ing a manual for program operations and I hope to conduct The first HomeCare clinic opened in September 2003, compliance studies throughout the coming year. four more sites were added gradually and a sixth will open FQHCs are located in every state. Those in Connecticut shortly. We also have partnered with other local commu- were eager to collaborate with UConn Health Center to nity health centers. All of these FQHCs contract with the provide psychiatric care, and I assume the same would be UConn Health Center for HomeCare services. true in many states. The HomeCare program is a success- A child psychiatrist and a child/adolescent psychiatric ful example of a university-affiliated public model of care. APRN work together at these clinics. HomeCare is now It shows what is possible in any jurisdiction—with a small staffed with two full-time and two part-time APRNs, two grant and innovative thinking. part-time child psychiatrists and an administrative assistant. All are UConn Health Center employees. We recently Geraldine Pearson, PhD, APRN, is an assistant professor added a first-year child psychiatry fellow to our staff group. at the University of Connecticut Medical School and the As would be expected, the population we serve is psychi- director of Connecticut’s HomeCare program. To reach her, atrically and psychosocially complex, requiring a high level e-mail [email protected]. of case management. As a result, for every hour of direct Judith Robbins, LCSW, JD, CCHP, represents the National care provided by APRN staff, another hour of indirect care Association of Social Workers on the NCCHC board of is allotted to meet these case management and other indi- directors and chairs the 2008 juvenile health committee. She rect needs. is the director of Yale Behavioral Health’s Juvenile Detention Early on, we saw that the FQHCs needed psychiatric Mental Health Program in the Department of Psychiatry at services for their pediatric populations. With the funders’ Yale Medical School, New Haven, CT. approval, psychiatric evaluation and medication man- If you’d like to comment on juvenile correctional health agement are also offered to FQHC patients who are not topics, write to NCCHC’s juvenile health committee c/o judicially involved, although the first priority is still treating Matissa Sammons at [email protected] or by justice-involved youth. And, at times, the populations over- mail to NCCHC, 1145 W. Diversey Pkwy., Chicago, IL 60614.

28 Summer 2008 • CorrectCare www.ncchc.org Full page Ad 8” x 10 1/2” Page 29

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A Day in the Life of a Jail Clinical Social Worker

To give readers a snapshot into the if any referrals require that I initiate discharge planning work lives of their colleagues, we 7:40 Review staff referrals and inmate self-referrals for dis- asked a few CCHPs to describe a charge planning and schedule appointments for them typical day on the job. Marie Carlin, MA, LCSW, CCHP, jotted down a 7:45 Look up locations that need to be seen today CCHP Program wonderfully detailed diary of activi- 8:15 Discharge planning for two inmates. One is a 66-year- Strong and ties (slightly edited for length). old Viet Nam veteran with serious medical problems, PTSD A clinical social worker at symptoms and a recent alcohol problem; this is his first time Growing the Hartford (CT) Community in jail and he wants help getting into a VA recovery program. Correctional Center since 1997 and We contacted the VA homeless coordinator and VA shelter The number of a CCHP since 2002, Carlin juggles a workload that includes program, requested discharge medications and gave him dis- newly certified mental health intake assessments, case management and charge instructions. If he returns from court, we will proceed professionals rose crisis intervention for inmates with severe mental illness, with the application for the VA residential recovery program. by 23% last year, discharge planning for mental health clients and liaison with 11:00 Fax medical insurance applications to the depart- and 9 out of 10 service providers in the community. ment of social services; complete and fax discharge summa- Commenting about the care provided in jails generally, ries to community treaters current CCHPs she says, “I don’t think most people realize the extent and renewed their cer- quality of the mental health services we try to provide to 11:30 Discharge planning with two more inmates tification. inmates. Our staff is very professional and often able to offer Afternoon excellent mental health care with very limited resources.” 12:00 Send secured e-mail to social worker in public Morning defender’s office providing information that may be useful in determining a disposition at court; contact our IT desk 7:00 Collect charts for the day from medical records office for help with a computer glitch 7:10 Read and answer e-mail: a social worker in the pub- Review discharge list and check off completed lic defender’s office alerting jail staff of a seriously mentally ill 12:30 dis inmate coming in who might be a danger to himself and charges; make list of inmates to see tomorrow; list the others; my supervisor informing me that I was accepted inmate ID photos I need for medical insurance applications to attend a cross-training reentry meeting; jail reentry staff and fax it to our mental health secretary, who will get them notifying me that my client is being referred for a program for me and asking if I want to be notified when it is determined 12:45 Discharge planning with three inmates. One is a (yes, I do; he is being treated for psychiatric illness and will 22-year-old male with serious cognitive deficits and charged need a discharge summary and meds) with rape. Contact the court to provide information relevant to disposition; contact a community support group 7:30 Review jail diversion referrals of inmates who came he attended to arrange for assistance with transitioning to in last night to see if they have information about disposi- the community tion or diversion plans with which I need to collaborate, or 1:15 Read and answer e-mail from jail diversion staff, organize notes from discharge planners’ recent meeting, CCHP Exam Dates propose to the nursing supervisor a system to keep track of discharge medications, providing part of the administrative October 19 Chicago, IL policies and copies of forms for recording information 1:35 Review charts of potential discharge clients to assess November 5 Hendersonville, NC accuracy of mental health scoring and determine which February 21 Multiple regional sites need to be scheduled and which need to have mental health scores lowered For more information about the application process or 2:00 End of my day at HCCC the exams, please visit www.ncchc.org/cchp. Also, we are seeking additional sites for the Feb. 21 And how does Carlin feel at the end of the day? “I do and future exams, as well as CCHPs to proctor the love my job!” she exclaims. exams. If you would like to participate, contact the CCHP coordinator at 773-880-1460 or [email protected].

30 Summer 2008 • CorrectCare www.ncchc.org Upper Respiratory Infection: upper respiratory tract infection, laryngitis, laryngopharyngitis, nasopharyngitis, Renal Impairment pharyngitis, respiratory tract infection, rhinitis, viral respiratory tract infection The safety and efficacy of maraviroc have not been specifically studied in patients with renal impairment, Less Common Adverse Events therefore maraviroc should be used with caution in this population. In the absence of metabolic inhibitors, renal The following adverse events [defined as always serious by MedDRA-Preferred -(Critical)- Terms] occurred in <2% clearance accounts for approximately 25% of total clearance of maraviroc. Maraviroc concentrations may be of SELZENTRY-treated patients. These events have been included because of their seriousness and either increased in patients with renal impairment, especially when CYP3A inhibitors are coadministered. Patients with a increased frequency on SELZENTRY or are potential risks due to the mechanism of action. Events attributed to the creatinine clearance of less than 50 mL/min who receive maraviroc and a CYP3A inhibitor may be at an increased patient’s underlying HIV infection are not listed. risk of adverse effects related to increased maraviroc concentrations, such as dizziness and postural hypotension. Cardiac Disorders: unstable angina, acute cardiac failure, coronary artery disease, coronary artery occlusion, Thus, patients with a creatinine clearance of less than 50 mL/min should receive maraviroc and a CYP3A inhibitor myocardial infarction, myocardial ischemia only if the potential benefit is felt to outweigh the risk, and they should be monitored for adverse effects. Hepatobiliary Disorders: hepatic cirrhosis, hepatic failure, cholestatic jaundice Hepatic Impairment Infections and Infestations: Clostridium difficile colitis, viral meningitis, pneumonia, septic shock The pharmacokinetics of maraviroc have not been sufficiently studied in patients with hepatic impairment. Because maraviroc is metabolized by the liver, concentrations are likely to be increased in these patients. Musculoskeletal and Connective Tissue Disorders: myositis, osteonecrosis, rhabdomyolysis, blood CK increased Gender Neoplasms benign, Malignant and Unspecified (including Cysts and Polyps): abdominal neoplasm, anal cancer, Population pharmacokinetic analysis of pooled Phase 1/2a data indicated gender (female: n=96, 23.2% of the total basal cell carcinoma, Bowen’s disease, cholangiocarcinoma, lymphoma, metastases to liver, esophageal carcinoma, population) does not affect maraviroc concentrations. Dosage adjustment based on gender is not necessary. squamous cell carcinoma, squamous cell carcinoma of skin, tongue neoplasm (malignant stage unspecified) Race Nervous System Disorders: cerebrovascular accident Laboratory Abnormalities Population pharmacokinetic analysis of pooled Phase 1/2a data indicated exposure was 26.5% higher in Asians (N=95) as compared to non-Asians (n=318). However, a study designed to evaluate pharmacokinetic differences between Table 3 shows the treatment-emergent Grade 3-4 laboratory abnormalities that occurred in >2% of patients Caucasians (n=12) and Singaporeans (n=12) showed no difference between these two populations. Only 14 Black receiving SELZENTRY. subjects were included in the population pharmacokinetic analysis. No dosage adjustment based on race is needed. Table 3 Maximum Shift in Laboratory Test Values (Without Regard to Baseline) OVERDOSAGE Incidence ≥2% of Grade 3-4 Abnormalities (ACTG Criteria) A4001027 and A4001028 (Pooled Analysis, Up to 48 Weeks) The highest dose administered in clinical studies was 1200 mg. The dose limiting adverse event was postural hypotension, which was observed at 600 mg. While the recommended dose for SELZENTRY in patients receiving a Laboratory Limit SELZENTRY Placebo + OBT CYP3A inducer without a CYP3A inhibitor is 600 mg twice daily, this dose is appropriate due to enhanced metabolism. Parameter Preferred Twice daily Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, Term, % + OBT respectively, those expected in humans at the intended exposure of 300 mg equivalents twice daily. However, no N =421* (%) N =207* (%) significant QT prolongation was seen in the studies in treatment-experienced patients with HIV using the Aspartate aminotransferase >5.0x ULN 4.5 2.9 recommended doses of maraviroc or in a specific pharmacokinetic study to evaluate the potential of maraviroc to Alanine aminotransferase >5.0x ULN 2.4 3.4 prolong the QT interval. Total bilirubin >5.0x ULN 5.7 5.3 There is no specific antidote for overdose with maraviroc. Treatment of overdose should consist of general Amylase >2.0x ULN 5.5 5.8 supportive measures including keeping the patient in a supine position, careful assessment of patient vital signs, Lipase >2.0x ULN 4.9 6.3 blood pressure and ECG. Absolute neutrophil count <750/mm3 3.8 1.9 If indicated, elimination of unabsorbed active maraviroc should be achieved by emesis or gastric lavage. *Percentages based on total patients evaluated for each laboratory parameter Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since maraviroc is moderately protein bound, dialysis may be beneficial in removal of this medicine. DRUG INTERACTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility Effect of Concomitant Drugs on the Pharmacokinetics of Maraviroc Carcinogenesis Maraviroc is a substrate of CYP3A and Pgp and hence its pharmacokinetics are likely to be modulated by inhibitors Long-term oral carcinogenicity studies of maraviroc were carried out in rasH2 transgenic mice (6 months) and in and inducers of these enzymes/transporters. Therefore, a dose adjustment may be required when maraviroc is rats for up to 96 weeks (females) and 104 weeks (males). No drug-related increases in tumor incidence were found coadministered with those drugs [see Dosage and Administration]. in mice at 1500 mg/kg/day and in male and female rats at 900 mg/kg/day. The highest exposures in rats were Concomitant use of maraviroc and St. John's wort (hypericum perforatum) or products containing St. John's wort approximately 11 times those observed in humans at the therapeutic dose of 300 mg twice daily for the treatment is not recommended. Coadministration of maraviroc with St. John's wort is expected to substantially decrease of HIV-1 infection. maraviroc concentrations and may result in suboptimal levels of maraviroc and lead to loss of virologic response Mutagenesis and possible resistance to maraviroc. For additional drug interaction information see Clinical Pharmacology. Maraviroc was not genotoxic in the reverse mutation bacterial test (Ames test in Salmonella and E. coli), a chromosome aberration test in human lymphocytes and rat bone marrow micronucleus test. USE IN SPECIFIC POPULATIONS Impairment of Fertility Pregnancy Pregnancy Category B Full pageMaraviroc Addid not impair mating or fertility of male or female rats and did not affect sperm of treated male rats The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed at approximately 20-fold higher exposures (AUC) than in humans given the recommended 300 mg twice daily dose. with maraviroc in rats at exposures (AUC) approximately 20-fold higher and in rabbits at approximately 5-fold 17 PATIENT COUNSELING INFORMATION higher than human exposures at the recommended daily dose (up to 1000 mg/kg/day in rats and 75 mg/kg/day See Medication Guide. in rabbits). During the pre-and post-natal development studies in the offspring, development of 8”the offspring, x 10 1/2” including fertility and reproductive performance, was not affected by the maternal administration of maraviroc. Patients should be informed that if they develop signs or symptoms of hepatitis or allergic reaction following use However, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies of SELZENTRY (rash, skin or eyes look yellow, dark urine, vomiting, abdominal pain), they should stop SELZENTRY are not always predictive of human response, SELZENTRY should be used during pregnancy only if clearly needed. and seek medical evaluation immediately [see Warnings and Precautions]. Antiretroviral Pregnancy Registry Patients should be informed that SELZENTRY is not a cure for HIV infection and patients may still develop illnesses To monitor maternal-fetal outcomes of pregnant women exposed to SELZENTRY and other antiretroviralPage agents, associated 31 with HIV infection, including opportunistic infections. The use of SELZENTRY has not been shown to an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by reduce the risk of transmission of HIV to others through sexual contact, sharing needles or blood contamination. calling 1-800-258-4263. Patients should be advised that it is important to: Nursing Mothers • remain under the care of a physician when using SELZENTRY; • take SELZENTRY every day as prescribed and in combination with other antiretroviral drugs; The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breast-feed their • report to their physician the use of any other prescription or nonprescription medication or herbal products; infants to avoid risking postnatal transmission of HIV infection. Studies in lactating rats indicate that maraviroc is • inform their physician if they are pregnant, plan to become pregnant or become pregnant while taking SELZENTRY; extensively secreted into rat milk. It is not known whether maraviroc is secreted into human milk. Because of the • not change the dose or dosing schedule of SELZENTRY or any antiretroviral medication without consulting potential for both HIV transmission and serious adverse reactions in nursing infants, mothers should be instructed their physician. not to breast-feed if they are receiving SELZENTRY. Caution should be used when administering SELZENTRY in patients with a history of postural hypotension or on Pediatric Use concomitant medication known to lower blood pressure. Patients should be advised that if they experience The pharmacokinetics, safety and efficacy of maraviroc in patients <16 years of age have not been established. dizziness while taking SELZENTRY, they should avoid driving or operating machinery. Therefore, maraviroc should not be used in this patient population. Geriatric Use There were insufficient numbers of subjects aged 65 and over in the clinical studies to determine whether they respond differently from younger subjects. In general, caution should be exercised when administering SELZENTRY Distributed by in elderly patients, also reflecting the greater frequency of decreased hepatic and renal function, of concomitant Pfizer Labs disease and other drug therapy. Division of Pfizer Inc, NY, NY 10017 notes

This department features news and information from Board of Directors 2008 Election NCCHC’sNCCHC’ supportingi organizationsi i andd otherh partners thath BBallotingll i will take place at the National Conference on share our goal of promoting quality health care in correc- Correctional Health Care in Chicago. Members in atten- tional institutions. If your organization has news to share, dance will have the opportunity to vote for the candidates please contact [email protected], 773-880-1460. of their choice. A special voting area will be set up in the exhibit hall at the Academy’s booth. On-site voting will be Academy of Correctional Health Professionals conducted during exhibit hall breaks, Oct. 19-20. Members who cannot attend the conference may participate in the CareerCenter Joins Vast Network election by voting online Oct. 3-17. The Academy CareerCenter has joined the National Healthcare Career Network, a Web-based network of American Academy of Child and Adolescent association-sponsored online career centers that share Psychiatry job listings, resumes and career development content. The Academy joined the network to improve services to The AACAP has launched an online curriculum on sub- members and advertisers. Already there’s been a marked stance use disorders. It is structured as an 11-lecture series increase in traffic with over 1,500 job openings listed on the that provides the latest knowledge on substance depen- Academy CareerCenter site. dence, diagnosis and treatment. The AACAP created the curriculum in response to high demand for physician train- Benefits to Members ing in identifying and treating adolescent substance use. • Access every job opportunity in your field all in one place In a study published in the July issue of the Journal of the • Circulate resumes to more employers American Academy of Child and Adolescent Psychiatry, it • Compare opportunities nationally and locally was recommended that clinicians who work with adoles- Benefits to Employers cents receive training in substance use assessment during • Maximize return on investment with greater reach into medical school or residency. The study also indicated that your field many pediatricians do not screen adolescents for substance • Recruit by posting every job to multiple career centers use and even fewer feel comfortable conducting a compre- hensive evaluation or providing referrals for treatment. The curriculum, which offers 5.5 hours of CME credit, is available at www.aacap.org/cs/onlinecme.

[ETHICAL. PROFESSIONAL. CARING.] American Psychological Association In response to reports of alleged involvement of a psychologist (not an APA member) in an abusive interrogation “THIS IS NOT A JOB. of a Guantanamo detainee, the APA has issued a statement of its position on such activities. “No psychologist—APA THIS IS MY CALLING.” member or not—should be directly or indirectly involved in any form of detention or interrogation that could lead to Sylvia, a physician, loves Now celebrating 30 years psychological or physical harm to a detainee.” The associa- correctional healthcare. of excellence in providing tion has identified 19 interrogation techniques that it pro- She knows it’s where she quality correctional hibits, but notes that the list is not exhaustive. Techniques is meant to serve. Sylvia is healthcare, Prison Health prohibited as in violation of professional standards include the kind of professional you Services asks you to waterboarding, hooding, forced nudity and stress positions. find at Prison Health Services. take a closer look. The APA states that it will “pursue ethics investigations where evidence indicates that an APA member has violated our ethical standards.” View the statement and related documents at www.apa.org/releases/statement.html.

SYLVIA, M.D. Society of Correctional Physicians The Society has recently enhanced its Web site with two members-only features: a message board for information sharing and a directory of members. The directory enables SCP members to update their own contact information as well as look up their colleagues. Access requires log-in and Prison Health Services, Inc. password. The site also posts an archive of the SCP newslet- 105 Westpark Drive, Ste. 200 ter, CorrDocs, which is available to all visitors. To learn more Brentwood, TN 37027 800-729-0069 about these features or to sign up for the message board, www.prisonhealth.com visit www.corrdocs.org.

32 Summer 2008 • CorrectCare www.ncchc.org Patient Safety (continued from page 7)

procedures, education and training, discussion forums, and NCCHC’s new Patient Safety counseling or intervention strategies. standard reminds us that leadership should foster a culture of patient For Further Reading . . . Application of the Standard safety and error reporting and pri- • In 1996, the Institute of Medicine NCCHC’s standards have always promoted health care oritize the steps taken by health care launched an ongoing effort to assess and quality and now, in keeping with community standards of professionals each day to keep their improve the nation’s quality of care. Two care, we are encouraging correctional facilities to be even patients from harm. IOM reports—To Err Is Human (1999) and more aware of, and target, preventable adverse events. Crossing the Quality Chasm (2001)—made In terms of compliance, we interpret the Patient Safety huge waves and have guided efforts across standard in relation to other standards. For example, patient R. Scott Chavez, PhD, MPA, the nation to improve patient safety. Learn safety could be viewed as seriously jeopardized if correc- CCHP-A, is NCCHC’s vice presi- more at www.iom.edu/?id=21805. tional and health care administrators did not adequately dent and liaison to the policy and • The two research studies cited in this resolve systemic problems related to quality (A-06), staffing standards committee. Jennifer E. article are as follows: levels (C-07) or suicide prevention (G-05). Collectively, such Kistler, MPH, is NCCHC’s director Collins, S., Currie, L., Patel, V., Bakken, issues could point to a bigger problem of a culture that of accreditation. To contact her, S., & Cimino, J. J. (2007). Multitasking by neglects patient safety. e-mail [email protected], call clinicians in the context of CPOE and CIS On the other hand, NCCHC would look favorably on a 773-880-1460 or write to NCCHC, use. Studies in Health Technology and system that identified a potential weakness that could jeop- 1145 W. Diversey Parkway, Chicago, Informatics,129(Pt 2), 958-962. ardize patient safety and took steps to correct it. IL 60614. Rosenstein, A. H., & O’Daniel, M. (2008). Correctional facilities often face fiscal and personnel An archive of past Spotlight arti- A survey of the impact of disruptive behav- shortages. Adding medical errors to the mix only com- cles is available at the CorrectCare iors and communication defects on patient pounds the problems. When health care delivery systems page at www.ncchc.org. safety. Joint Commission Journal on Quality fail and errors occur, this has a ripple effect, leading to finan- and Patient Safety, 34(8), 464-471. cial woes, litigation, personnel shortages and poor health care outcomes.

PARTICIPATE IN AN INNOVATIVE CME SERIES TODAY!

Interactive patient cases available PROGRAM CO-CHAIRS for FREE CME credit. John G. Bartlett, MD Professor of Medicine ᮣ Review patient presentation Division of Infectious Diseases Johns Hopkins University School of Medicine and history Baltimore, MD ᮣ Develop differential diagnosis ᮣ Select diagnostic tests Patricia Barditch-Crovo, MD ᮣ Decide treatment plan Assistant Professor Division of Infectious Diseases ᮣ Review expert recommendations Johns Hopkins University School of Medicine Two challenging patient cases of Baltimore, MD approximately 2 hours each are Lisa A. Scotti, BSN, ACRN, MPH available online. Nurse Educator/Nurse Clinician II, Polk Service Johns Hopkins Hospital Baltimore, MD

PRESENTED BY IN COOPERATION WITH To participate in this CME activity (valid from 8/15/2008 through 8/15/2009) please visit www.correctionscme.com For further information, email [email protected] or call 609.454.0860.

Supported by an educational grant by Boehringer Ingelheim Pharmaceuticals, Inc.

33 www.ncchc.org Summer 2008 • CorrectCare ads EMPLOYMENT Ublf!uif!Ofyu!Tufq!jo!Zpvs!Dbsffs

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tional facilities in New Jersey. ACADEMY CareerCenter Physicians (psychiatry, general medicine) Dentists (general dentistry) Nurse Practitioners Looking for a new job? This benefi t is free to job seekers. RN’s/LPN’s Post your resume online and showcase your skills and experience to prospective employers to fi nd the best job opportunities. Interested candidates please contact: Hiring? Receive member discounts on job postings and access Physicians/Dentists: Frank Zura, Coordinator, the most qualifi ed talent pool to fulfi ll your staffi ng needs. [email protected], Phone: 609 304-7504 Nurses: Nancy DeLapo, Director, For more information: Please visit the career services [email protected], Phone 856 797-4761 section of our Web site at www.correctionalhealth.org or contact us at 877.549.2247.

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Public Health Behind Bars: From Prisons to About CorrectCare™ MARKETPLACE Communities. This book examines the burden 10% discounts are offered for Academy mem- of illness in the prison population, the impact CorrectCare is the quarterly magazine of the bers (single copies) and for bulk purchases of on public health as prisoners are released and National Commission on Correctional Health Care. a single title. To order, or for a catalog of all of how to coordinate care between correctional Its mission is to publish news, articles and com- the titles NCCHC offers, visit www.ncchc.org or and community providers. Over 40 practi- mentary of relevance to professionals in the field of call 773-880-1460. tioners, researchers and scholars in correc- correctional health care. tional health, mental health, law and public NCCHC Standards for Mental Health policy offer recommendations for care that Subscriptions: CorrectCare is mailed free of Services in Correctional Facilities. These is humane for inmates and beneficial to the charge to members of the Academy of Correc- standards support a forthcoming accreditation communities they reenter. Edited by Robert tional Health Professionals, key personnel at program designed for mental health services Greifinger. Springer (2007), hardcover, 576 pp, accredited facilities and other recipients at our that operate under an authority different from $89.95. See table of contents at www.ncchc.org. health services. The mental health standards discretion. To see if you qualify for a subscription, parallel those for health services in format Bates’ Pocket Guide to Physical Examination submit a request online at www.ncchc.org or by and substance, and cover the general areas of and History Taking, 5th Ed. The classic Bates e-mail to [email protected]. The magazine is also care and treatment, clinical records, admin- approach in an outline format with exam tech- posted at www.ncchc.org. istration, personnel and legal issues. The dif- niques on the left and abnormalities and inter- ference is that they make more explicit what pretations on the right. This edition features Change of Address: Send notification four weeks the standards require for adequate delivery of greater emphasis on patient interview tech- in advance, including both old and new addresses mental health services. Together, these tools niques, a new chapter on older adults and new and, if possible, the mailing label from the most can help facilities determine proper levels of images of abnormalities, with 500+ color draw- recent issue. See page 1 for contact information. care, organize systems more effectively and ings and photographs. A PDA download has efficiently, and demonstrate that constitution- outlines of exam procedures and techniques. Editorial Submissions: Submitted articles may be al requirements are being met. Glossary and By Lynn Bickley & Peter Szilagyi. LWW (2005), published at our discretion. Manuscripts must be index. Softcover, $69.95 softcover, 416 pp, $42.95 original and unpublished elsewhere. For guidelines, contact Jaime Shimkus at [email protected] or 773-880-1460. We also invite letters or correction Immediate Career Opportunities of facts, which will be printed as space allows. at our newest state of the art facility “Not until I discovered corrections health care was my career complete.” “I love this job for the variety it oﬀers.” “My skills are put to the test daily.” ADVERTISER INDEX

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35 www.ncchc.org Summer 2008 • CorrectCare Q & A Expert Advice on NCCHC Standards by R. Scott Chavez, PhD, MPA, CCHP-A, and Examples of violations of this standard include inmate Jennifer E. Kistler, MPH workers taking pulse and oximetry readings on patients waiting for sick call, checking abnormal blood pressure readings and changing bandages, or even taking supplies First Aid Training for Inmates from the cabinet. Inmates translating sick call slips from We are considering offering basic first aid and CPR English is a violation of patient confidentiality. These classes to our inmates. It is not our intention to use situations may place inmate workers in a position of Qinmates in any capacity to provide routine care for power over their peers. It may be tempting to use inmate other inmates, but rather, to provide those inmates who workers in health care delivery when staffing is an issue, are interested with skills that may be of value in the event but besides violating the NCCHC standard, doing so fre- of an extreme emergency situation. What is NCCHC’s posi- quently violates state laws, invites litigation and brings tion on training inmates in basic health care issues? Would discredit to the correctional health care field. you consider this a violation of standard C-06? C-06 Inmate Workers prohibits the use of inmates as Infirmary RN Supervisor health care workers. Since you have stated that you We operate an infirmary and have a supervising reg- Awould not be using inmates in this capacity, there istered nurse on every shift. Is this what is intended is no violation of the standard. NCCHC supports health Qby the standard? education programs for inmates. As long as you do not In standard G-03 Infirmary Care, Compliance intend to use inmates to provide ongoing care, there is no Indicator 4 requires that “a supervising registered reason that they should not have an opportunity to learn Anurse is on site at least once every 24 hours” (empha- CPR and basic first aid. sis added). A supervising RN need not be present on every shift. Periodic Health Assessments In standard E-12 Continuity of Care During CCHP... Incarcer ation, periodic health assessments are men- Qtioned in Compliance Indicator 7. Do all inmates require a periodic health assessment on an annual basis? Expertise…pp Leadership… Recognition No, the standard does not require an annual health The rewards of a career in correctional health care assessment. The responsible physician determines are many. But health professionals working in correctional Athe frequency and content of periodic health assess- settings also face unique challenges. Achieving profes- ments based on protocols promulgated by nationally rec- sional certification is the surest way to prove that you have ognized professional organizations. Periodic assessments the tools to meet these challenges. are likely based on age, gender and risk factors. Certain Sponsored by the National Commission on elements of the assessment, such as mammogram or Correctional Health Care, CCHP is the premier national prostate exam, are repeated at appropriate frequencies. certification program for professionals in correctional health care. The CCHP designation identifies you as one who Correction: 2008 Prison Standards, Oral Care has demonstrated mastery of national standards and the In the first printing of the 2008 Prison Standards, PE-06 knowledge expected of leaders working in the field of Oral Care had two errors regarding time frames. An erra- correctional health care. ta page (which has been sent to those who purchased the Already a CCHP? Isn’t it time you considered Advanced book) reads as follows: Certification? The advanced program recognizes CCHPs • Compliance Indicator 1: Oral screening by the dentist or who have demonstrated excellence, commitment and qualified health care professionals trained by the dentist contribution to the field. is performed within 7 days of admission. Both the CCHP and CCHP-A exams are given several • Compliance Indicator 3: An oral examination is per- times a year in a proctored setting. Apply today and join formed by a dentist within 30 days of admission. the thousands of correctional health care professionals who have earned the distinction of CCHP and CCHP-A. For R. Scott Chavez, PhD, MPA, CCHP-A, is NCCHC’s vice presi- more information, visit the Web at www.ncchc.org/CCHP. dent and liaison to the policy and standards committee. Jennifer E. Kistler, MPH, is NCCHC’s director of accreditation. Send your question to [email protected] or call 773-880-1460.

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