class action claims

C

rrectCare

Fall 2014 | Volume 28 | Issue 4

®

The magazine of the National Commission on Correctional Health Care

CLASS ACTION CLAIMS

Gluing Together Systemwide Judicial Relief

PREA: Transforming Culture and Practice in Correctional Facilities Music Therapy Tames Behavioral Symptoms Understanding Anticoagulant Agents and Lab Tests

National Commission on Correctional Health Care 1145 W. Diversey Parkway, Chicago, IL 60614

CorrectCare™ is published quarterly by the National Commission on Correctional Health Care, a not-for-profit organization whose mission is to improve the quality of health care in our nation’s jails, prisons and juvenile confinement facilities. NCCHC is supported by the leading national organizations representing the fields of health, law and corrections.

contents Features 8

Class Action Claims: Gluing Together Systemwide Judicial Relief

10

PREA: Transforming Culture and Practice in All Correctional Facilities

13

Music Therapy Tames Symptoms of Behavioral and Mental Health Problems

14

Understanding Anticoagulant and Anti-platelet Agents and Related Lab Tests

8

Departments 2

NCCHC News: New Mental Health Standards Coming

5

Legal Affairs: The Doctor’s Role in an Illegal Body Cavity Search: Duped or Duplicit?

7 22 23

NewsWatch

24 27 28

CCHP Page

Field Notes Journal Preview: Substance Abuse Treatment Program Helps Reduce Recidivism

Classified Ads and Ad Index Standards Q&A

Cover design by Jill Cooper; cover image © Fotosearch.com

Our Independence Matters The National Commission on Correctional Health Care has no membership or dues. NCCHC does not require any affiliation to be considered for accreditation, certification or employment as a consultant or surveyor, or to serve on committees or the board of directors. NCCHC staff and spouses are not allowed to accept gifts or consulting fees from those we accredit or certify. NCCHC is impartial, unbiased and expert. And dedicated only to recognizing and fostering improvements to the field of correctional health care.

C rrectCare Fall 2014 | Volume 28 | Issue 4

®

BOARD OF DIRECTORS

Renee Kanan, MD (Chair) American College of Physicians Patricia N. Reams, MD, CCHP (Chair-Elect) American Academy of Pediatrics Judith Robbins, LCSW, CCHP-MH, CCHP-A (Immediate Past Chair) National Association of Social Workers Jayne Russell, MEd, CCHP-A (Secretary) Academy of Correctional Health Professionals Thomas J. Fagan, PhD, CCHP-MH (Treasurer) American Psychological Association Thomas L. Joseph, MPS, CAE (President and CEO) National Commission on Correctional Health Care Carl C. Bell, MD, CCHP National Medical Association Patricia Blair, JD, CCHP American Bar Association Eileen Couture, DO, CCHP American College of Emergency Physicians Kevin Fiscella, MD American Society of Addiction Medicine Joseph Goldenson, MD American Public Health Association Eric Handler, MD National Association of County and City Health Officials Robert L. Hilton, RPh, CCHP American Pharmacists Association JoRene Kerns, BSN, CCHP American Correctional Health Services Association Ilse R. Levin, DO American Medical Association Douglas A. Mack, MD, CCHP American Association of Public Health Physicians Nicholas S. Makrides, DMD American Dental Association Pauline Marcussen, RHIA, CCHP American Health Information Management Association Edwin I. Megargee, PhD, CCHP-MH International Association for Correctional and Forensic Psychology Charles A. Meyer, Jr., MD, CCHP-A American Academy of Psychiatry and the Law Eugene A. Migliaccio, DrPH American College of Healthcare Executives Ronald C. Moomaw, DO American College of Neuropsychiatrists Robert E. Morris, MD, CCHP Society for Adolescent Health and Medicine Mary Muse, RN, CCHP-A American Nurses Association Peter C. Ober, PA-C, CCHP American Academy of Physician Assistants Joseph V. Penn, MD, CCHP American Academy of Child and Adolescent Psychiatry Peter E. Perroncello, MS, CCHP American Jail Association George J. Pramstaller, DO, CCHP American Osteopathic Association Sheriff B. J. Roberts National Sheriffs’ Association David W. Roush, PhD National Partnership for Juvenile Services Steven Shelton, MD, CCHP-A Society of Correctional Physicians Carolyn Sufrin, MD, PhD American College of Obstetricians and Gynecologists Ryung Suh, MD American College of Preventive Medicine Ana Viamonte Ros, MD Association of State and Territorial Health Officials Barbara A. Wakeen, RD, CCHP Academy of Nutrition and Dietetics Henry C. Weinstein, MD, CCHP American Psychiatric Association Nancy B. White, LPC American Counseling Association Liaison Pending National Association of Counties Copyright 2014 National Commission on Correctional Health Care. Statements of fact and opinion are the responsibility of the authors alone and do not necessarily reflect the opinions of this publication, NCCHC or its supporting organizations. NCCHC assumes no responsibility for products or services advertised. We invite letters of support or criticism or correction of facts, which will be printed as space allows. Articles without designated authorship may be reprinted in whole or in part provided attribution is given to NCCHC. Send correspondence to Jaime Shimkus, Editor NCCHC, 1145 W. Diversey Pkwy., Chicago, IL 60614 Phone: 773-880-1460; Fax: 773-880-2424 [email protected]; www.ncchc.org For advertising, contact Carmela Barhany at [email protected]

NCCHCnews New Mental Health Standards Coming in 2015

W

ith the 2014 editions of the Standards for Health Services for jails and prisons published earlier this year, NCCHC convened an expert task force to likewise update the Standards for Mental Health Services in Correctional Facilities. The task force’s work is now complete and the manual will be published early in 2015. This revision is timely given the increasing interest in quality improvement in mental health services provided in correctional settings. This second edition represents the culmination of hundreds of hours of careful review by a large group of experts, including specialists in psychiatry, psychology, social work and professional counseling. The task force was the core group that shepherded the review process. This group then elicited and reviewed recommendations and suggestions from correctional mental health care experts as well as feedback from the field. The task force was co-chaired by Thomas Fagan, PhD, CCHP-MH, and Henry Weinstein, MD, CCHP. Other members were Sharen Barboza, PhD, CCHP-MH, Edwin Megargee, PhD, CCHP-MH, Joseph Penn, MD, CCHP, Judith Robbins, LCSW, CCHP-MH, CCHP-A, and Nancy White, LPC.

More Insight Into What the Standards Require As with the first edition, the manual aligns with the jail and prison Standards, but makes more explicit what the standards require for constitutionally acceptable delivery of mental health services. Furthermore, the task force discussed every standard in the 2014 editions to come to consensus on what would carry over to the mental health manual. Because of the targeted focus of these standards, not every standard in the jail and prison manuals appears in the mental health manual. For example, standards on chronic disease services, nursing assessment protocols and medical diets are omitted from the mental health manual. Ultimately, the mental health standards are a valuable tool to help correctional facilities determine proper levels of care, organize systems more effectively and efficiently, and demonstrate that constitutional requirements are being met. They also are the foundation of NCCHC’s mental health services accreditation program. The field will get its first look at the new standards at a preconference seminar at NCCHC’s National Conference on Correctional Health Care, Oct. 18-22 in Las Vegas.

Save the Date! April 11-14

JCHC Now Indexed by Thomson Reuters

Spring Conference on Correctional Health Care Hyatt Regency, New Orleans Bright ideas and new solutions! In one of the nation’s most vibrant cities, this conference brings peers together to address specific challenges, make new contacts and leave with more preparation and confidence for the everyday questions and strategic issues you face.

In July, NCCHC’s Journal of Correctional Health Care was accepted for coverage by Thomson Reuters. Retroactive to Volume 18, Issue 1 (2012), JCHC will be abstracted in the following indexes: • Current Contents/Social and Behavioral Sciences • Journal Citation Reports/Social Sciences Edition • Social Sciences Citation Index

Calendarof events October 18-22 National Conference on Correctional Health Care, Las Vegas, NV October 19

CCHP exam, Las Vegas, NV

February 21

CCHP exam, regional sites

April 11-14

Spring Conference on Correctional Health Care, New Orleans, LA

April 12

CCHP exam, New Orleans, LA

June 6

CCHP exam, regional sites

July 10-11

Correctional Health Care Leadership Institutes, Long Beach, CA

July 12-13

Correctional Mental Health Care Conference, Long Beach, CA

For the complete list of CCHP exams, including regional exam sites, see www.ncchc.org/cchp.

New Mobile App Makes Navigating the Conference a Snap! Just in time for the National Conference on Correctional Health Care, we are pleased to announce the launch of the NCCHC Conference App. Make connections, set up your schedule and research the speakers and sessions! You’ll enjoy all of these benefits: • Create a personalized agenda • Find sessions by keyword search or browse by time or topic • Find abstracts and speaker information • Explore the searchable exhibitor directory • Get oriented with venue and show floor maps • See who’s attending and reach out to make valuable connections • Receive important messages from NCCHC • Get real-time updates. To download the app to your smart phone, search for “NCCHC events” in your app store. Then ... • Click “Download Your First Guide” • Click “Redeem” • Enter ncchc1014 • Say “Yes” to “enable push notifications” to get messages from NCCHC

2 Fall 2014 • CorrectCare

www.ncchc.org

2014 National Conference on Correctional Health Care CONNECT TO

COLLABORATE

COMMIT

EXCELLENCE

October 18-22 • Paris Hotel, Las Vegas The world’s largest conference for correctional health offers you practical research, best practices and excellent networking. Invest in your professional development and refresh your skills and contacts in 100 sessions, workshops, discussions and roundtables. Preconference seminars offer in-depth information and up to 14 additional CE hours. The conference begins Sunday evening with the Exhibit Hall Opening Reception.

Why Attend?

Continuing Education

• Targeted education and excellent networking with peers and experts from every segment of the correctional health care field: clinicians, administrators, staff and management.

Up to 32 hours of CE credit may be earned in each category below. This maximum number includes credits offered at preconference seminars. See the Preliminary Program or conference website for details. • CCHP • Nurse • Physician • Psychologist • Social Worker • General

• Up to 32 hours of continuing education credits with 100 sessions and preconference seminars to choose from. • Comprehensive coverage of all aspects of correctional health care: chronic care, mental health, suicide prevention, oral health care, crisis intervention, liability challenges, risk management and more … • NCCHC is the nation’s leader in correctional health care education, certification and accreditation. Learn from respected authorities with years of experience in health care delivery in prisons, jails and juvenile facilities.

Preconference Seminars Topical, informative seminars will help you stay up-to-date on critical issues facing the field. Maximize your education while you learn about NCCHC standards and other vital subjects. Sunday, October 19 Saturday, October 18 9 am - 5 pm

8:30 am - 12 pm

• The Affordable Care Act and How •An In-Depth Look at NCCHC’s 2014 Standards for Health Services It Will Affect Correctional Health Care in Jails • Beyond Good and Evil: Inside the •An In-Depth Look at NCCHC’s 2014 Standards for Health Services Mind of the Psychopath in Prisons 1:30 pm - 5 pm •An In-Depth Look at NCCHC’s • Prison Rape Elimination Act: Standards for Mental Health Training for Health Staff Services in Correctional Facilities • Chronic Disease Management •Active Surveyor Training

Registration Information • Regular: $495 • Academy Member: $445 (you may join the Academy when you register for the conference) • One Day: $275 (provides access to all events that day) • Preconference Seminars: $185 full-day sessions, $99 half-day sessions • Guest Registration: $75 (exhibit hall events only) For preregistration, full payment must be received by Oct. 14. For on-site registrations, a fee of $25 may apply. Visit www.ncchc.org to register online or to download a form, or call NCCHC at 773-880-1460.

Everything you love about Paris, right in the heart of the Las Vegas Strip All conference activities will take place at the Paris Hotel. Situated in the heart of the Las Vegas Strip, this elegant hotel combines classic style, fine craftsmanship and authentic details to create a unique ambiance. To reserve online, see the Hotel tab at www.ncchc.org/nationalconference, or call 877-603-4389 and indicate that you are with NCCHC.

Full Registration Includes the Following • Admission to 100 concurrent sessions where you can create a curriculum that meets your needs • Opening ceremony and keynote address • Lunch & Learn events • Roundtable breakfast discussions • Informative exhibits • Exhibit hall reception • Poster displays • Breaks and refreshments in the exhibit hall • Final program and session abstracts • Conference proceedings online for download before and after the event

CALEA®: The Gold Standard in Public Safety Accreditation by Janice Dixon

HI ad v2_Layout 1 1/23/14

J

ust as the National Commission on Correctional Health Care’s Standards for Health Services for jails and prisons is the cornerstone for its health services accreditation program, the Standards for Law 11:45 AM Page 1 Enforcement Agencies is the foundation for the international accreditation program operated by the Commission on Accreditation for Law Enforcement Agencies, Inc. CALEA is a not-for-profit public safety credentialing orga-

CORRECTIONS FORUM regularly features articles on Correctional Healthcare. All members of the NCCHC are qualified to receive A FREE SUBSCRIPTION to CORRECTIONS FORUM; print or digital issues. Go to correctionforum.net and click on the red "Subscribe To The Magazine" button to begin receiving your free subscription."

nization whose primary mission is to enhance public safety professionalism through the promulgation and administration of standards. The organization has been in existence for more than 35 years and is governed by a board of 21 commissioners. CALEA provides professional accreditation services for law enforcement agencies, public safety communication agencies, public safety training academies and campus security organizations. More than 1,000 client agencies actively participate in CALEA programming. Participation options feature a tiered approach of law enforcement accreditation, currently based on 189 standards, and advanced law enforcement accreditation, with 483 standards. The standards address six major law enforcement areas: role, responsibilities and relationships with other agencies; organization, management and administration; personnel administration; law enforcement operations, operational support and traffic law enforcement; detainee and courtrelated services; and auxiliary and technical services. CALEA provides all of its publications in an electronic format through a service maintained by PowerDMS™, a documents management provider. As is true for all CALEA programs, the law enforcement standards, which were originally published in 1983, are continuously reviewed by CALEA’s Commission Board and new standards or revisions to existing standards are made whenever necessary and updated in the electronic access soon after adoption.

Commitment to Professionalism When a law enforcement agency has achieved CALEA accreditation, it is an indication that the department has voluntarily opted to comply with a set of internationally recognized standards, and then invited a team of assessors—who are other public safety professionals trained in the accreditation process—to come to its department, interview its personnel, speak with members of the community and verify that it is in compliance with standards. Accreditation compliance provides the necessary reports and data a CEO needs to make fact-based, informed management decisions. It also strengthens an agency’s accountability, within both the agency and the community, through a continuum of standards that clearly define authority, performance and responsibilities. Being CALEA accredited can limit an agency’s liability and risk exposure because it demonstrates that internationally recognized standards and best practices for law enforcement have been met. Its CALEA accreditation award is a symbol that it is committed to being the best professional law enforcement agency it can be.

Janice Dixon is CALEA’s communications specialist and editor of the CALEA E-Communiqué. CALEA is based in Gainesville, VA. Learn more about the organization at www.calea.org. 4 Fall 2014 • CorrectCare

www.ncchc.org

Legalaffairs The Doctor’s Role in an Illegal Body Cavity Search: Duped or Duplicit? by Fred Cohen, LLM

P

omona, California, police officers Freeman and Johnson arrested Clifford George for a parole violation. In fact, I think they believed, and acted on the belief, he was a drug dealer. At the city jail, George is said to have undergone or faked some sort of seizure. He was seen to insert in his anus a plastic baggie that, due to the officers' asserted training and experience with drugs, they believed was a bag of cocaine. That is, the seizure either was faked by the defendant as a way to hide drugs as he was shaking violently on the floor, or the officers somehow made up the seizure after observing the insertion of the plastic bag and wanted a medical reason for the hospitalization and anal probe, which produced the bag containing cocaine base. George sued the officers, the emergency room doctor and some nurses under 42 U.S.C. § 2983, alleging an illegal search and seizure when the doctor forcibly, without his consent, removed the plastic bag from his rectum. Plaintiff acted pro se initially and the defendants were granted summary judgment. In George v. Edholm (9th Cir. 2014), the court reversed and essentially held that George had a right to present his case to a jury.

Discussion Dr. Edholm, the emergency room physician, is a private citizen whose conduct would not ordinarily be attributed to an agency of government. However, he may be viewed as a state actor where there is a close nexus between his seemingly private behavior and the state. The use of coercion or significant persuasion may convert, as is possible here, private action to official action. The court notes: A reasonable jury could conclude that Officers Freeman and Johnson gave false information about George's medical condition to the hospital staff and to Dr. Edholm, with the intent of inducing Edholm to perform an invasive search. There is evidence in the record showing that Freeman and Johnson knew that George did not have a seizure. They both admitted in response to written requests from George that the paramedics told them that George had not had a seizure, and they both testified in their depositions that they believed George was faking a seizure. There is evidence in the record showing that neither Freeman nor Johnson believed that George had swallowed any cocaine. They both denied telling anyone that he had done so. But the hospital triage record indicates that hospital staff

had been told by police (“per P.D.”) that, in addition to inserting cocaine into his rectum, George had also ingested cocaine and had possibly had a seizure. George specifically stated that he heard Freeman tell Edholm that George had swallowed cocaine. There is evidence in the record that the information that George had ingested cocaine and had possibly had a seizure led Edholm to perform a more invasive search than he otherwise would have. Edholm testified that his decision to treat George aggressively was based in part on that information. Finally, there is evidence in the record that Freeman and Johnson physically assisted Edholm by turning George on the table and holding his legs, and that Freeman emphasized to Edholm the necessity for prompt action in removing the cocaine from George's rectum.

continued on page 6

Correctional Mental Health Report CORRECTIONAL MENTAL HEALTH REPOR Edited by Fred Cohen, LL.B., LL.M.

• Legal updates and case reviews that analyze important court decisions and their impact on the way you manage, house and treat this difficult population— and help you avoid multimillion-dollar lawsuits; • Proven treatment programs and operating procedures for assisting and managing mentally disordered offenders—everything from the correct way to prepare treatment plans and progress notes, to the design of residential programs; • Psycho-pharmaceutical developments; • Strategies for managing scarce resources—how to get critically needed budget items approved, work with third-party providers, gain the support and cooperation of mental health, medical and other agencies;

PRACTICE

Vol. 9 No. 2

•

ADMINISTRATI ON

Pages 17 - 32

Brad H.: And So It Goes by Fred Cohen Regular readers of this publication should at least be noddingly familiar with the New York City case of Brad H. It has been discussed on these pages numerous times: See, New York City Agrees to Provide Services for Jail Releasees With Mental Illness 5 CMH 1 (May/June 2003); The Brad H. Settlement: A Further Comment 5 CMH 3 (May/June 2003); Brad H. Under Stress 5 CMH 71 (Jan/Feb 2004); and, Brad H. Settlement Modified 5 CMH 87 (March/April 2004). The suit was filed in August 1999 and vigorous litigation followed with State Supreme Court Justice Richard Braun invariably ruling for the plaintiff class: which, generally speaking, includes New York City inmates with mental illness confined now or in the future and who need a variety of specified forms of help as part of discharge planning and reentry. On January 8, 2003, a Settlement was reached and on May 6, 2003, two distinguished professionals were appointed as Monitors: Henry Dlugacz and Erik Roskes. After plowing through their twelfth regular report, dated February 6, 2007*, my first thought was I hope they are being generously compensated. Helping these class members who in the past were unceremonio usly dumped on City streets at night is a high calling. Brad H. itself is properly looked at as a breakthrough case in moving beyond the constitutional parameters of mental health care while confined and following these often hapless releasees into the communi*Available at: www.urbanjustice.org/ujc/litigation/mental.html See BRAD, page 30

© 2007 Civic Research Institute.

•

T

LAW

ISSN 1526-9515

New York Parolees With Psych Disabilities Sue for Assistance iatric On February 22, 2007, a class action complaint was filed in the Federal District Court for the Southern District of New York. Counsel includes the Legal Aid Society (and brilliant project director, John Boston), Urban Justice Center (which prevailed in the historic Brad H. case),1 and the prestigious Wall Street law firm of Cravath, Swaine & Moore. Why write about this case even at the early complaint stage? The legal claims made on behalf of the as yet uncertified plaintiff class of parolees with psychiatric disabilities is, in my experience, unprecedente d. What is the gist of this cause of action and 69-page complaint? Compressed in the extreme, the assertion is that parolees and prospective parolees with psychiatric disabilities (not limited to serious mental illness) are disabled within the meaning of ADA2 and without compensatory measures for community reintegration their condition will worsen, and they will become violators unless adequately accommodate d. In 69 pages, obviously there is more: A variety of federal and state statutes are cited

as being violated.— Social Security Act, Medicaid, Food Stamps, and Public Assistance, e.g., — along with a summary, sort-of-obligatory due process claim. By proceeding in this fashion, Messiah S. v. Alexander (S.D.N.Y. 2007) avoids the strictures of DeShaney “actual custody” requirement the for constitutionally mandated care and the further strictures of the “seriousness” and “deliberate indifference” requirements.3 The class action is further limited to New York City residents, I suppose, to expand the statutory and agency basis for the claims. However, if this action is won, or simply settled, it is inconceivable that the rest of the state would long be exempt. What do the plaintiffs want? Not much, really; certainly not much when contrasted with money damage claims or injunctive relief requiring the expenditure of millions of dollars for staff and facilities. The class demands that the defendants help prepare them for release — e.g., with pre-release applications for aid for which they are eliSee PAROLEES, next page

ALSO IN THIS ISSUE Tragedy After Victory in Forced Medication Case . . . . . . . . . . . . . . . . . . 19 Competence, Collateral Order Doctrine, and Confusion. . . . . . . . . . . . . . 20 Research Review & Commentar y: Suicide in Solitary . . . . . . . . . . . . . . . 21 Monitoring California Style: Musings, Money, and Morphing. . . . . . . . . . 22 Mental Health Parity Act Would Not Reach Corrections . . . . . . . . . . . . . 22 Pain Management: A Digression ....................... . . . . . . . 23 Juvenile Justice Corner. . . . . . ....................... . . . . . . . . 24 Book Review . . . . . . . . . . . . . ....................... . . . . . . . . 25 Iowa High Court Voids Probation Sex Offender Treatment Condition . . . . 26 The Public Defender’s Office: A Broker for “Help”? . . . . . . . . . . . . . . . . . 26 County Liable Even When Individual Officers Are Exonerated . . . . . . . . . 27 Texas Gets Serious About Treatment ....................... . . . . 27 Dogs for Cell Extraction . . . . . ....................... . . . . . . . . 28 Corrections Cannot Delegate Duty to Provide Medical Care and Access to Records . . . . . . ....................... . . . . . . . . 29

Save $30 With This Ad!

Photocopying or other reproduction

without written permission is

expressly prohibited and is a

violation of copyright.

• Treatment options for special offender groups—from juvenile to elderly; • Quality assurance protocols; • A review of the latest research and writing in the field—new books, journal articles, research reports, monographs—so you can keep up to date on new developments that can help you do your job better. To order, go to http://www.civicresearchinstitute.com/cmhr.html and click on “Add to Cart”. Enter Promotion Code E02R for your discount. Or call 609-683-4450.

Correctional Mental Health Report Published in print and online Frequency: 6x annually ISSN: 1526-9515 Subscription: $179.95 NCCHC Discount: $149.95 Order by December 31, 2014

5 www.ncchc.org

™

Fall 2014 • CorrectCare

Legal Affairs

(continued from page 5)

Having said that the doctor could have been coerced or duped into becoming a state actor, is there also a basis to hold the doctor personally liable? To do so, there must be evidence that Dr. Edholm intended to assist the officers in this probe and seizure. The court declines to rule on this but makes it rather clear that the right facts could make Dr. Edholm complicit as a willing agent; an understanding with a “wink and a nod” that this was a probe to obtain criminal evidence and that any medical risks to George justifying the rectal probe were fanciful. The search here, performed with an instrument to spread the anus and a forceps-like device to probe and remove the bag, is found to be at least as invasive as other searches that are now judicially condemned as constitutionally intrusive. There is evidence that this was not an emergency and that far less intrusive measures (which included a liquid forced though George's body) were available (e.g., stool monitoring). Since George's predicament was of his own making, only the possibility of the greatest imminent harm could justify such intrusive action. The only possible risk was the rupture of the baggie and that cannot justify the intrusiveness of this search. Reversed.

Comment Normally, an emergency room physician sees emergencies and consent is not an issue. Here, the doctor was either duped by the officers or a willing participant in evidencegathering, and from the narrative it seems the latter is more likely. Thus, a doctor must pause before going into an arrestee's anus with instruments and a purgative to retrieve an inserted item. Ask to see a warrant; be clear on the facts constituting a life-threatening emergency and record why less intrusive alternatives were rejected.

Fred Cohen, LLM, is the executive editor of the Correctional Health Care Report. This article is in press for a future issue of CHCR, ©2014 Civic Research Institute, Inc., and is reprinted here in slightly abridged form with permission of the publisher. All rights reserved. For subscription information, contact Civic Research Institute, 4478 U.S. Route 27, P.O. Box 585, Kingston, NJ 08528; 609-683-4450; www.civicresearchinstitute.com.

Accreditation:

Pursuit of Excellence Recognition FRom the most Respected name in coRRectional health caRe

Get recognized for your quality and commitment • Objectively validates the areas in which the health care facility is doing well and areas for improvement • Promotes and documents an efficient, well-managed system of health care delivery • Educates and trains staff on NCCHC standards • Minimizes the occurrence of adverse events, thus reducing health care-related liability • Recognizes staff contributions and excellence • Helps obtain community support and provides justification for budget requests • Protects the health of the public, staff and inmates No other accreditation comes close to receiving the professional acceptance and recognition that goes with NCCHC health services accreditation.

Isn’t it time you became NCCHC accredited?

For more information on ncchc accreditation, contact us at: (773) 880-1460 • [email protected] • www.ncchc.org

Accred FP CC HPH Ad 4c.indd 1

6


9/5/13 7:37 PM

www.ncchc.org

Newswatch California Adopts New Policies to Protect Mentally Ill In response to a federal judge’s order, the California Department of Corrections and Rehabilitation has adopted sweeping new policies aimed at greatly improving the treatment of mentally ill inmates, according to the Los Angeles Times and other media reports. The policies were developed in negotiation with lawyers and a court-appointed special master and address the use of solitary confinement and use of force, as well as improvements in mental health care and suicide prevention. Some key changes include the following: • The practice of placing mentally ill inmates in solitary confinement and other types of segregation will be limited, with approximately 2,500 inmates moved to other housing. • Specially designed new units will provide intensified mental health treatment and inmates will be allowed more outof-cell time for recreation and other activities. • Corrections officers must address a prisoner’s psychiatric state before deciding to use pepper spray or other force. • “A robust mental health care program” will include daily rounds by psychiatric technicians and daily meetings between custody staff and mental health staff. Juvenile Facilities Urged to Conduct Suicide Screening With incarcerated youth committing suicide at a rate two to three times higher than that of youths in the general population, all juvenile detention centers should systematically screen for suicide risk at intake, according to psychologist Karen Abram, an expert on suicide risk among youths in detention. Abram is the lead researcher on “Suicidal Thoughts and Behaviors Among Detained Youth,” a study highlighted in an Office of Juvenile Justice and Delinquency Prevention bulletin. Research shows that suicide attempts often happen very soon after detention, making prompt screening critical, Abram said. The study also calls for increased psychiatric services in youth detention facilities. • http://jjie.org/expert-calls-for-suicide-screening-in-alljuvenile-detention-centers • http://ojjdp.gov/pubs/243891.pdf Study Projects Steep Rate of Growth in Older Prisoners An in-depth study of growth patterns in the Bureau of Prisons found that the number of prisoners age 50 and older increased 330% from 1994 to 2011. The study, conducted by the Urban Institute, also projects that the proportion of BOP inmates age 50+, especially those age 65+, will increase at a steep rate, and that older prisoners could make up nearly 28% of the BOP population by 2019. The report’s recommendations for policy and research include expanding data-driven knowledge on older prisoners, developing an easy-to-use assessment/screening tool for correctional officers, training officers to be more knowledgeable about aging and the needs of aging prisoners, developing cost-effective management plans and expanding use of preventive health care, especially dental care. • www.urban.org/publications/413222.html

Prison Population Rises for First Time Since 2009 After a three-year decline, the nation’s state and federal prison population increased slightly in 2013, according to the Bureau of Justice Statistics. Overall, prisons held an estimated 1,574,700 inmates on Dec. 31, 2013, an increase of 4,300 prisoners compared to a year before. While the state prison population increased by about 6,300, the federal prison system experienced its first decline since 1980, a decrease of approximately 1,900 inmates. Overall, U.S. state and federal correctional facilities hold about 1.6 million prisoners. Weight Loss May Delay Kidney Disease in Diabetics In a 12-year study of more than 5,000 overweight people with type 2 diabetes, those in the diet and exercise group— who lost, on average, 8.6% of their body weight—were 31% less likely to develop high-risk chronic kidney disease compared to study participants who received only support and education. This study indicates that an intense program of major behavioral change, including counseling, group sessions and mutual reinforcement, can work, the study’s lead author said. The study was published in The Lancet Diabetes and Endocrinology. • http://uk.reuters.com/article/2014/08/21/us-health-kidneys-diabetes-weight-idUKKBN0GL1QT20140821

A World of Opportunities The GEO Group, Inc. is the world’s leading provider of correctional, detention, and community reentry services. GEO employs top-notch talent and promotes safety, diversity, and inclusion.

Nationwide Opportunities Health Services Administrators • Medical Directors Mental Health Directors • Directors of Nursing Physicians • Dentists

www.jobs.geogroup.com | www.geogroup.com | Follow us: 866.301.4436, EXT 5863

EOE AA M/F/Vet/Disability

7 www.ncchc.org


CLASS ACTION CLAIMS Gluing Together Systemwide Judicial Relief by Jared A. Goldman, JD

The claim asserted that all inmates are exposed to the same injury—a substantial risk of serious harm—as a result of statewide policies and practices

T

he award of class action certification is often the gateway for obtaining lifesaving systemwide judicial relief in broken correctional health care systems. It also can be the beginning of a decades-long, burdensome and inefficient route to reform. No matter what your perspective may be, the approval of class certification is a pivotal moment when a few individuals’ claims are recognized as more than an aggregation of disparate grievances and are instead litigated as a common contention applicable to a broader group, requiring a common remedy. In litigation brought under the Eighth Amendment of the U.S. Constitution, the importance of class action certification can’t be overstated because, under the Prison Litigation Reform Act, judicial relief can “extend no further than necessary to correct the violation of the Federal right of a particular plaintiff or plaintiffs.” Naturally, the scope of a remedy tailored for all inmates in a correctional system will be vastly different from a remedy tailored for an individual inmate or a handful of inmates. Recently, in Parsons v. Ryan, an ongoing case brought by Arizona inmates against senior officials in the Arizona Department of Corrections, the ADC officials asserted an argument, as characterized by the U.S. Court of Appeals for the Ninth Circuit, that “Eighth Amendment claims can never be brought in the form of a class action.” This argument, if successful, would end impact litigation in the prisons as we know it. To understand the issue and the decision

reached by the Ninth Circuit, some background about class actions is necessary.

Requirements for Class Certification Class certification is governed by Federal Rule of Civil Procedure 23. Under Rule 23(a), a party seeking certification of a class or subclass must satisfy four requirements: 1. The class must be so numerous that including all individual members as named plaintiffs is impracticable. 2. There must be questions of law or fact common to the class. 3. The claims or defenses of the representative parties must be typical of the claims or defenses of the class. 4. The representative parties must be able to fairly and adequately protect the interests of the class. These requirements are often referred to, respectively, as “numerosity,” “commonality,” “typicality” and “adequacy of representation.” The proposed class must also satisfy one of three subsections in Rule 23(b), which defines different types of classes. One of those subsections, Rule 23(b)(2), is typically used for the certification of civil rights actions. It requires that the party opposing the class (e.g., prison officials) acted or refused to act on grounds that apply generally to the class, so that judicial relief is appropriate for the class as a whole. In 2011, the U.S. Supreme Court raised the bar for class certification in the widely publicized case of Wal-Mart Stores, Inc. v. Dukes. In Wal-Mart, the district court certified a class consisting of all of Wal-Mart’s 1.5 million female


www.ncchc.org

employees in a case claiming discriminatory employment practices. The employees did not allege that Wal-Mart maintained an express policy discriminating against women. Rather, the employees asserted that local managers’ discretion over pay and promotion was exercised disproportionately in favor of men, and Wal-Mart’s failure to limit its managers’ authority amounted to unlawful discrimination. In support of their claim, the employees presented statistical evidence of pay and promotion disparities, anecdotal evidence of discrimination in numerous cases and expert testimony of a corporate culture making stores vulnerable to gender bias. Despite the evidence presented, the court found the award of class certification unsupported. The court acknowledged a general policy of allowing managerial discretion, which may have resulted in a number of independent discriminatory acts. But the court found that the employees failed to offer significant proof that Wal-Mart operated under a general policy of discrimination. Thus, the employees’ claims failed to show commonality or “some glue holding together” the local managers’ alleged discriminatory decisions. The court explained that to show commonality, plaintiffs must demonstrate that the class members have suffered the same injury—which means more than just suffering a violation of the same law. Plaintiffs’ claims must depend on a common contention capable of classwide resolution, which means that “determination of its truth or falsity will resolve an issue that is central to the validity of each one of the claims in one stroke.” In the context of correctional health care litigation, Wal-Mart underscores that inmates cannot obtain class certification merely by showing widespread constitutional violations across the system. Some further commonality between the inmates’ claims must be shown, which brings us back to Parsons v. Ryan.

Statewide Policies: The ‘Glue’ of Commonality

The inmates in Parsons complained that numerous statewide policies and practices governing health care and conditions in isolation cells exposed them to a substantial risk of harm to which the ADC officials were indifferent. The inmates supported their complaint with detailed factual allegations of statewide policies and practices related to inadequate staffing, delays and denials of medical care, substandard dental care, failures to provide therapies for the mentally ill and detention of inmates in isolation for months or years without outdoor exercise or meaningful interaction with others. The district court granted the inmates motion for class certification, specifying a class of “[a]ll prisoners who are now, or will in the future be, subject to the medical, mental health, and dental care policies and procedures of the ADC.” It also certified a subclass of “[a]ll prisoners who are now, or will in the future be, subjected by the ADC to isolation, defined as confinement in a cell for 22 hours or more each day or confinement in [certain housing unit].” The ADC officials appealed from the district court’s award of class action certification, principally arguing that the district court erred in concluding that the inmates pos-

sessed commonality. Citing the Supreme Court’s decision in Wal-Mart, the ADC officials asserted “Eighth Amendment health care and conditions-of-confinement claims are inherently case specific and turn on many individual inquiries. That fact is an insurmountable hurdle for a commonality finding because Wal-Mart instructs that dissimilarities between class members ‘impede generation of common answers.’” Said another way, the ADC officials argued that the inmates failed to satisfy the commonality requirement because a systemic constitutional violation of the sort alleged by the inmates is merely a collection of individual constitutional violations, each of which depends on the particular facts and circumstances of each case. The Ninth Circuit rejected the ADC officials’ broad attack on inmates’ ability to bring class actions. It distinguished claims alleging deficient care provided on previous occasions, or to particular inmates, from the kind of claim asserted by the inmates in Parsons, in which the inmates made a future-oriented claim based on systemwide deficiencies. Specifically, the inmates complained that all inmates in ADC custody are exposed to the same injury—a substantial present and future risk of serious harm—as a result of ADC policies and practices of statewide application. The court pointed to 10 statewide ADC policies and practices, to which all ADC inmates are exposed, which the court considered the “glue” holding together the class. All members of the class, as explained by the court, are subject identically to those same policies and practices. Additionally, the constitutionality of each policy and practice (i.e., whether it creates a systemic, substantial risk of harm to which the defendants are deliberately indifferent) “can be answered in a single stroke.” By way of example, the court discussed the inmates’ claim that the ADC officials maintain an unconstitutional policy and practice of severe understaffing across all ADC medical facilities. This allegation, according to the court, presented a question of law and fact common to all ADC inmates. Because the inmates alleged that every single inmate is placed at substantial risk of future harm due to the general unavailability of adequate care, the question of whether the ADC’s staffing policies pose a risk of serious harm to all ADC prisoners is a common contention answerable as to the entire class at the same time. An inmate-byinmate inquiry is unnecessary. “Either ADC employs enough nurses and doctors to provide adequate care to all of its inmates or it does not ...” While the Ninth Circuit’s decision affirming the continuing viability of inmate class actions is not precedential throughout the United States, similar post-Wal-Mart decisions have been reached in lower courts in several states. Greater scrutiny of class claims can be expected. But it seems likely that class actions in correctional health care litigation will not come unglued.

Jared A. Goldman, JD, is a partner at Best Best & Krieger, LLP, Sacramento, CA. Among other clients, Goldman represents the federal court-appointed receiver of the State of California’s prison medical system. 9

www.ncchc.org


PREA: Transforming Culture and Practice in All Correctional Facilities by Robert W. Dumond, LCMHC, Diplomate CFC

T

tent with the com-

he Prison Rape Elimination Act of 2003 is poised to transform the culture and practice in jails, prisons, community corrections, juvenile facilities and police lockups. The first legislation of its kind in the world, this historic law was passed by a unanimous U.S. Congress and signed into law on September 4, 2003. It aims to prevent, detect and respond to all forms of sexual abuse, both inmate-on-inmate and staff-on-inmate. To achieve these ambitious goals, an impressive assembly of federal resources and contracted organizations have been engaged to improve how correctional agencies identify the problem in their facilities, ensure appropriate prevention, provide adequate training and education and effectively manage incidents that do occur. To explore this issue, this article will consider four perspectives: (1) what we now know about sexual abuse in detention, (2) collaboration to improve corrections, (3) accountability and ensuring compliance and (4) staff training and inmate education. It also cites many helpful resources.

munity standard

What We Now Know

Foremost is the requirement to ensure that the care and treatment provided is consis-

When the issue of sexual abuse in detention was first being debated, there was a paucity of empirical research on the prevalence of prisoner sexual violence, and the studies that did exist had differing levels of subjects and response rates, inconsistent definitions of what constitutes sexual abuse, wide diversity in reported prevalence and difficulty in extrapolating national estimates based on type of correctional institution. This was remedied by PREA, which enlisted the assistance of a number of federal agencies. The National Prison Rape Elimination Commission was convened from 2004 through 2009, tasked with conducting an exhaustive study of sexual abuse in confinement and establishing a set of national standards. The Commission conducted hearings throughout the United States, with testimony from hundreds of survivors, correctional authorities, community advocates and medical and mental health experts. This culminated with the publication of the National Prison Rape Elimination Commission Report, a thorough examination of NPREC’s work, and the presentation of the first iteration of National Standards for adult prisons and jails, community corrections, juvenile facilities and lockups. The National Institute of Justice funded a series of primary research on prisoner sexual violence in the United States, including an anthropological study of inmate culture in maximum security prisons; an examination of violence in the nation’s third largest prison system (Texas); studies of changing correctional culture and gendered violence and safety in women’s correctional facilities; and reviews of effective prevention programs in prisons and promising practices in jails and juvenile facilities. This body of evidence helped raise awareness and improve policy and practice in

correctional facilities nationwide. The Bureau of Justice Statistics’ National Prison Rape Statistics Program has established a comprehensive data collection strategy to assess the prevalence of sexual abuse in incarceration settings. Using well-constructed research methodologies with precise, behaviorally specific definitions, coupled with innovative techniques (such as the use of audio computer-assisted self-interviews) and extremely large sample sizes, BJS has been able to demonstrate that prisoner sexual violence is widespread, affecting 4% of adult prison inmates and 3.2% of jail inmates—an estimated 80,600 in an anonymous survey reported in 2013. The BJS data also confirm that what is formally reported to correctional authorities represents a small fraction of the actual occurrence, and that the predominant forms of sexual abuse in detention are about evenly split between staff sexual misconduct and inmate-on-inmate abuse. A very clinically significant finding is that there are certain groups of individuals who are increased risk of victimization, including lesbian, gay, bisexual and transgendered inmates; inmates with mental illness and mental health issues; and individuals with a history of sexual assault. This finding highlights the unique risks of these populations and helps health care professionals respond more proactively.

Collaboration to Improve Corrections Federal legislation sometimes demands compliance without providing the necessary resources. In this case, PREA again assembled a host of federal agencies and collaborating partners to help correctional agencies implement change. The National Institute of Corrections became the initial clearinghouse for information, and also established a number of cooperative agreements with partners to assist in providing consultation, training and technical assistance (see Resources on page 12). The Bureau of Justice Assistance has directly helped correctional agencies respond to sexual abuse and implement the national PREA standards. Specifically, BJA has provided several rounds of funding for Protecting Inmates and Safeguarding Communities (providing more than $60 million) and, since 2011, Demonstration Projects to Establish “Zero Tolerance” Cultures for Sexual Assault in Correctional Facilities. It appears likely that these projects will continue to be funded in the future. More recently, the National PREA Resource Center has become the central repository for research on prevention, national trends, response strategies and best practices. A collaboration between BJA and the National Council on Crime and Delinquency, the PRC has taken the lead in assisting correctional agencies nationwide, providing resources, facilitating technical assistance and more.

Accountability and Ensuring Compliance As is well known to correctional health professionals, where the rubber meets the road is in the adoption of and com-


www.ncchc.org

pliance with national standards that guide agency policy, operating procedures and practice. Without these, staff have difficulty identifying what is expected of them and how to perform the multiple, complex tasks for which they are responsible. Standards are also the only means by which correctional administrators can ensure consistency, standardization and compliance with legal statutes, ethical guidelines and recommended best practices. National Standards A central purpose of PREA was to establish national standards for the detection, prevention, reduction and punishment of prison rape. In 2009 NPREC proffered a series of standards to the U.S. Attorney General, who, after three years of debate, examination and consideration, promulgated the National Standards to Prevent, Detect, and Respond to Prison Rape. The National Standards are behaviorally specific and encompass all aspects of custodial sexual abuse in 11 broad categories: prevention planning, responsive planning, training and education, screening, reporting, response to reports, investigations, discipline, health care, data collection and audits. What distinguishes these standards from, for example, NCCHC standards is the fact that these are mandatory; all U.S. correctional agencies are required to use these standards as the national benchmark. A number of standards affect the practice of all correctional health professionals. In many respects, they offer a substantially improved vision of how to respond to incidents of sexual abuse. Foremost is the requirement to ensure that the care and treatment provided is consistent with the community standard. These standards also require that health care professionals in confinement institutions collaborate and coordinate care with community health care providers who are experts in sexual assault, victim services and trauma. The following standards, while not exhaustive, point to this new approach to correctional health care, which now requires that correctional agencies must: • Provide training for custody staff and specialized training for investigative, medical and mental health staff • Specify first responder duties once an incident has been revealed • Provide a coordinated response upon learning of an incident of sexual abuse • Offer forensic exams and emergency and ongoing care • Attempt to make available a victim advocate from a rape crisis center • Improve screening and classification • Conduct sexual abuse incident reviews at the conclusion of every sexual abuse investigation Not all victims of sexual abuse experience the debilitating and painful effects of PTSD and other accompanying challenges, but without proper intervention, care and management, the likelihood of ongoing harm increases. Effective treatment eases the suffering and helps victims move to survivor and then “thriver.” It also helps to redirect and decrease the likelihood of negative long-term aftereffects that can affect both the victim and the community.

Correctional health professionals should work with their respective agencies to develop and implement policies and procedures to ensure compliance with these standards. It also is essential to establish interagency agreements and to develop positive working relationships with the SANE/ SAFE providers and with community sexual assault center personnel. Doing so will enable victims of sexual abuse to receive the best care designed to treat their symptoms and improve the likelihood of effective intervention. Audit, Auditors and Compliance Tools NPREC’s 2009 report noted that “Effective prison management demands both internal accountability measures and external scrutiny. The two go hand-in-hand, and neither is a replacement for the other.” The mechanism to ensure that correctional agencies are abiding by the stipulations of the standards is through an audit that must be conducted at least every three years by an auditor who has been trained and certified by the U.S. Department of Justice. Currently there are more 200 auditors who have been carefully selected and trained to perform ethical, professional audits. The audit instrument and its compliance indicators are detailed, specific and designed to help correctional agencies demonstrate conformity. All of the compliance indicators and audit tools are available online (see Resources) and should be reviewed by correctional health professionals to ensure that they are meeting the standards. Review Panel on Prison Rape PREA established the Office of Justice Programs’ Review Panel on Prison Rape to conduct annual hearings to assist BJS in identifying common characteristics of correctional facilities with high incidence of rape as well as those that have been successful in its abatement. The Review Panel also has been working to identify common characteristics of victims and perpetrators, and ways in which correctional facilities can be more effective. Correctional health professionals would find it useful to review the detailed analyses that have been conducted by the panel since 2006.

Staff Training and Inmate Education Unfortunately, advanced degrees and professional licensure do not necessarily ensure that health care staff are familiar with appropriate care and treatment for victims of sexual abuse, or competent to provide it. Staff training is the mechanism to ensure that correctional staff understand and can appropriately implement the agency’s policies and procedures. Staff training also is essential for alerting staff of “red flags” and difficulties that may exist so that institutional, staff and inmate safety can be maintained. Furthermore, correctional environments present unique challenges that change the dynamics of sexual abuse. So significant are the issues related to confinement that the U.S. Department of Justice’s Office on Violence Against Women recommends that prisons, jails and community corrections

continued on page 12 11

www.ncchc.org


PREA

(continued from page 11)

adopt the National Protocol for Sexual Assault for Medical Forensic Examiners (see Resources). NPREC and the National Standards require general training, and specific training for health care and investigative staff to appropriately respond to sexual abuse. This training should be evidence-based, trauma informed and gender responsive, and attempt to meet the needs of sexual abuse survivors both while incarcerated and, if appropriate, upon reentry to the community. The National Commission on Correctional Health Care, through an agreement with the National PREA Resource

Resources What We Now Know About Sexual Abuse in Detention • National Prison Rape Elimination Commission Report — www.ncjrs.gov/pdffiles1/ 226680.pdf • Bureau of Justice Statistics: Prison Rape Elimination Act (Sexual Violence in Correctional Facilities) — www.bjs.gov/index.cfm?ty=tp&tid=20 Collaboration to Improve Corrections • American University Washington College of Law – An End to Silence: The Project on Addressing Prison Rape — www.wcl.american.edu/endsilence • Just Detention International — www.justdetention.org • The Moss Group, Inc. — www.mossgroup.us • National PREA Resource Center — www.prearesourcecenter.org Accountability and Ensuring Compliance • National Standards to Detect, Prevent, and Respond to Prison Rape — ojp.gov/ programs/pdfs/prea_final_rule.pdf • PREA Audit Instruments — www.prearesourcecenter.org/node/1754 • List of Certified Auditors — www.prearesourcecenter.org/audit/list-of-certified-auditors Staff Training and Inmate Education • Recommendations for Administrators of Prisons, Jails, and Community Confinement Facilities for Adapting the U.S. Department of Justice’s A National Protocol for Sexual Assault Medical Forensic Examinations, Adults/Adolescents — www.justice.gov/ sites/default/files/ovw/legacy/2013/08/12/confinement-safe-protocol.pdf • NCCHC: Specialized Training: PREA Medical and Mental Care Standards — www.prearesourcecenter.org/file/1970/specialized-training-prea-medical-andmental-care-standards • NCCHC: Specialized Training: PREA Medical and Mental Care Standards – Instructor’s Curriculum Guide and Lesson Plans — www.prearesourcecenter.org/ sites/default/files/content/med-mh_lesson_plan_health_care_standards.pdf • Just Detention International: Hope Behind Bars – An Advocate’s Guide to Helping Survivors of Sexual Abuse in Detention — www.nasmhpd.org/docs/NCTIC/PREA_ Toolkit_Advocates_Manual_FINAL.pdf • Just Detention International: PREA: What You Need to Know Inmate – Education Facilitator’s Guide — www.prearesourcecenter.org/sites/default/files/content/ prc_inmate_ed_facilitators_guide.pdf?utm_source=AJAlert+2014-03-11&utm_ campaign=AJAlert+03_11_14&utm_medium=email • Just Detention International: PREA: What You Need to Know – Inmate Education Video— www.justdetention.org/en/PREA-what-you-need-to-know.aspx • National Sexual Violence Resource Center — www.nsvrc.org • U.S. Department of Veterans Affairs National Center for PTSD — www.ptsd.va.gov • Sidran Institute — www.sidran.org

Center, developed specialized trainings for correctional health professionals that it has provided at its educational conferences since Spring 2013. This effort has resulted in greater knowledge in the field and has promoted better understanding and a stronger skill set for those who have participated. Correctional health providers are encouraged to examine this curriculum and view the PowerPoints, videos and related resources. They also should strive to improve their knowledge about sexual trauma, remediating its effects and enhancing positive treatment outcomes; resources are available from the National Sexual Violence Resource Center, the National Center for PTSD and the Sidran Institute. Just Detention International, too, offers resources useful in understanding the uniqueness of the correctional environment, including an advocacy manual and an inmate education video with accompanying curriculum guide. Both are excellent introductions to the topic with which correctional health practitioners should be familiar.

Enhanced Tools and the Force of Law There are no panaceas to a problem as challenging as sexual abuse in confinement. Though it has been long known and reported, until the advent of the Prison Rape Elimination Act of 2003, correctional agencies were stymied in responding to a problem that we now know is prevalent and that has serious, debilitating effects upon its victims. With PREA’s passage, and combined with the plethora of resources that have been assembled, correctional agencies are now able to establish appropriate policies and procedures, comprehensive treatment, training and intervention strategies. Additionally, concrete and reliable external controls and oversight are in place to ensure that all correctional agencies continue their commitment to the National Standards. Corrections is a microcosm of the body politic—we recognize that most of those who are incarcerated will return to the community. Correctional health professionals now have enhanced tools and the force of law to ensure that all victims of sexual abuse, even though incarcerated, receive the level of care and treatment to which every citizen is entitled. As Americans, we believe that no one deserves to be raped while incarcerated—the punishment is the deprivation of liberty, not sexual abuse. By ensuring compliance with PREA and the National Standards, we will decrease this terrible scourge from confinement; improve recovery through proper, professional care and treatment; and support successful reintegration for those individuals who will be returning to community life.

Robert W. Dumond, LCMHC, Diplomate CFC, is a licensed mental health counselor and certified forensic consultant with 44 years of experience in mental health, corrections and criminal justice. He has presented on this topic at NCCHC conferences since 2008. Dumond has worked with numerous federal and correctional agencies, served as an expert witness and currently is on the faculty of Southern New Hampshire University. Contact him at [email protected].


www.ncchc.org

Music Therapy Tames Symptoms of Behavioral and Mental Health Problems by Alexandra Pajak, LMSW, CCHP

W

ith the deinstitutionalization of mental health care in the United States, correctional health care workers have become caretakers and service providers for the mentally ill in our communities. Effective mental health counseling is imperative in correctional environments but is often difficult to implement due to budgetary constraints. Music therapy has emerged as an efficacious and affordable form of behavioral and symptom management intervention in correctional environments.

Active Music Therapy The two primary forms of music therapy are active and receptive. Active music therapy uses musical instruments, music improvisation between the patient and therapist, free body movement, songwriting, singing and improvisation among group members. A focus on teamwork through improvisation is a common technique in active therapy and has been shown to be effective in forensic environments. A 2002 study concluded that active music therapy was effective in increasing self-esteem, expression of emotion and social skills (based on staff observations and patient self-report) among inpatient male adult sex offenders who took part in a 10-week therapy group that focused on drumming and improvisation. The authors attribute these improvements to the therapeutic techniques of balancing individual improvisation with nonverbal communication, balancing leading and following, and following guidelines within a structure. A similar study showed patients in forensic settings exhibited improved anger management skills and a decrease in avoidance as a coping technique. Another study of active music therapy examined the collaboration between a local theater company and an Australian maximum security prison. The inmates and theater company collaborated to write and perform a theatrical performance. During and after the performance, clinicians interviewed each of the seven prisoners who participated. All of the women reported feeling more connected to one another and the community and fewer feelings of isolation.

Receptive Music Therapy For budgetary and safety reasons, however, access to active music therapy tools may be unrealistic. Receptive music therapy is often more realistic and affordable in correctional settings. It takes place in a group therapy setting in which patients listen to music preselected by the therapist and/ or participate in lyric analysis. Listening to music can help “facilitate the process of self-expression … and provide a channel for transforming frustration, anger, and aggression into the experience of creativity and self-mastery,” according to a 1998 study on the effect of music therapy on preadolescents with emotional, learning and behavioral disorders. Multiple studies have concluded that receptive music

therapy can help alleviate symptoms in depression, dementia and schizophrenia. Symptoms of depression, such as social isolation and feelings of sadness, have been shown to decrease when receptive music therapy is added to standard therapy (e.g., individual therapy, psychotropic medication). This combined therapy has also been linked to a decrease in behavioral problems and an increase in positive social skills and mood among patients with dementia. Research also indicates that receptive music therapy helps to reduce depressive and anxiety symptoms in patients with Alzheimer’s-type dementia. Multiple studies have indicated improvements in both positive symptoms (auditory hallucinations) and negative symptoms (poverty of speech, minimal social interaction) among schizophrenic patients who participate in receptive music therapy. A 2014 study also links listening to music to improved attention at completing tasks.

Implementation

Multiple studies have concluded that receptive music therapy can help alleviate symptoms in depression,

Studies indicate that music therapy is most effective when dementia and combined with standard care. A review of current literature indicates that the most efficacious implementations of schizophrenia receptive music therapy involve 30- to 50-minute sessions two to five times a week. While symptoms of depression and psychosis may improve after as few as three to 10 sessions, the most significant outcomes tend to occur following a larger number of sessions, anywhere between 16 and 78. Importantly, patients show continued improvement in depression symptoms, anxiety and general functioning even six months after the sessions concluded. Most effective receptive music therapy interventions for dementia patients incorporate music familiar to and favored by the patients. Suggested format for a session Suggested Music for Receptive Music Therapy includes the following: 1. Check-in: Each member iden- Music Listening • “Carnival of the Animals—The Aquarium,” tifies one to two words to idenCamille Saint-Saens tify emotions experienced at the • “Appalachian Spring,” Aaron Copland beginning of the session. • “The Sorcerer’s Apprentice,” Paul Dukas 2. Music listening: After therapist-selected music is played, group • “Mad Rush,” Philip Glass members provide feedback about • “Clarinet Concerto in A major, K 622 Adagio,” Mozart emotions that they associate with • “Night on Bald Mountain,” Modest Mussorgsky the music. • “E.T. Bicycle Chase,” John Williams 3. Lyric analysis: This is a structured discussion of themes, for Lyric Analysis example, anger management, self- • “Royals,” Lorde esteem or body image. • “Another Day,” from Rent by Jonathan Larson 4. Closing: Each member identi- • “Unpretty,” TLC fies one to two words to describe • “Headlights,” Eminem reaction to the session. • “Love the Way You Lie,” Eminem with Rihanna • “Man in the Mirror,” Michael Jackson Alexandra Pajak, LMSW, CCHP, • “Brown Skin,” India.Arie has four years of experience doing • “We Are Young,” fun. mental health counseling in a jail. • “Dear Mama,” 2Pac 13

www.ncchc.org


Understanding Anticoagulant and Antiplatelet Agents and Related Lab Tests by Susan Laffan, RN, CCHP-RN, CCHP-A

N

©Eraxion/iStockphoto

urses who understand normal blood values related to a patient’s clotting time can play a key role in identifying potential poor patient outcomes. All laboratory results need to be reviewed by a clinician, but the nurse’s role is the proper notification to the clinician of any abnormal laboratory test results. This article will focus on the prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) values. The most common reason a patient is put on anticoagulant or antiplatelet medication is for the diagnosis of atrial fibrillation, better known simply as AFib. According to the Centers for Disease Control and Prevention, atrial fibrillation is the most common type of cardiac arrhythmia, with an estimated 2.66 million patients having this diagnosis in 2010. The American Heart Association estimates that there are 150,000 new cases per year in the United States, and 4% of patients over age 65 are affected. The risk factors for atrial fibrillation include high blood pressure, heart failure, diabetes, advanced age, heart disease and hypothyroidism. The two most common complications for atrial fibrillation are stroke and heart failure. Yet other conditions such as epistaxis (nosebleed), gastrointestinal bleeding, intracranial bleeding and exacerbation of traumatic injuries are possible. Anticoagulant and antiplatelet medication compliance is essential for preventing the complications listed above, yet too often patients who come into our correctional facilities have been either noncompliant or have missed doses because they do not have access to their medication during the arresting phase. These patients need to be identified during intake screening so the provider can properly address the patient’s current laboratory levels and medication regimen.

Types of Blood Thinners There are two main types of blood thinners. As explained by the U.S. National Library of Medicine, anticoagulants, such as heparin or warfarin (also called Coumadin), work on chemical reactions within the body to lengthen the time it takes to form a blood clot. Newer anticoagulants being prescribed include Xarelto (rivaroxaban) and Pradaxa (dabigatran). Antiplatelet drugs, such as aspirin or Plavix (clopidogrel), prevent blood cells called platelets from clumping together to form a clot. Anticoagulant medication is prescribed for treatment or prevention of a blood clot. Patients who are risk of having a blood clot include those who have atrial fibrillation, a

mechanical heart valve, endocarditis (an infection inside the heart), mitral stenosis (when one of the valves in the heart does not function properly) and some types of orthopedic surgery, including hip replacement. Antiplatelet medication is used to treat heart disease. These medications may be prescribed for patients with a history of coronary heart disease; after a heart attack; for angina, transient ischemic attacks, stroke, or peripheral artery disease; after angioplasty; and after stent placement following heart bypass or valve replacement. As a side note, there is a process known as the coagulation cascade that details all of the steps in the formation of blood clotting. This cascade is quite complicated, so it will not be described in this article. A PT test determines how much time it takes for blood to clot; the normal range for an adult is 9.9 to 13 seconds. The PT measures the extrinsic coagulation pathway by calculating the prothrombin ratio along with the IRN. The PT also determines warfarin levels and the vitamin K position. When a patient is on a blood thinner, the desired PT result to be considered therapeutic is about 1 ½ times the normal PT value. An INR is a calculation that standardizes the results of PT tests by comparing the patient’s PT to the mean normal PT. The normal INR range is between 2.0 and 3.0 for patients on oral anticoagulant therapy. The PTT is a measurement of the intrinsic coagulation pathway and the common coagulation pathway. The PTT also measures the heparin level in the body in case a patient is on anticoagulation therapy. An APTT test speeds up the clotting time compared to the PTT test, enabling it to detect clotting factor defects better. It has a normal range of 20 to 35 seconds.

Tips for Nurses It is essential to remember that these blood tests must be obtained within specific criteria that include the following: • The blood must be drawn swiftly with a clean venipuncture. • The blood collection tube must be full. • A clotted specimen will cause an inaccurate result. • Leaving a blood sample at room temperature for an hour or more may affect results. Other important points for nurses to note related to the PT, APTT and INR test results include the following: • Patients are to take anticoagulant drugs as prescribed by the provider. • Patients are not to self-medicate when receiving anticoagulant therapy (for example, determining when to take medication if a dose is missed, or when to begin or stop the medication in relation to a medical or dental procedure). • Over-the-counter drugs may increase or decrease the effects of the anticoagulant. • Patients are not to consume excess alcohol as it can affect liver function and cause a prolonged PT.


www.ncchc.org

• A high-fat diet may decrease the PT and INR values. • On the day of a lab draw, the anticoagulant therapy dose will be held until after the blood test is obtained in order to get an accurate reading. Most laboratories have a system for notifying the clinic if a test produces a critical value; generally, the result is both faxed and communicated by a phone call. Usually, the recipient of the critical value information is a nurse. Any and all abnormal or critical results must be reported to the clinician as soon as possible. (For more on this topic, see “Lab Tests and Chemistry Values: The Nurse’s Role,” CorrectCare, Summer 2014.) The nurse must document the date, time, name of the clinician notified and any interventions, treatments or orders received in the patient’s medical record. The margins of “normal” in these laboratory tests are slim. It is important for nursing staff to know if a patient is on anticoagulant or antiplatelet agents because if the patient is in the “abnormal” laboratory ranges, that may lead to very serious, and potentially fatal, conditions that may occur spontaneously or with trauma. Nurses need to use critical thinking skills to determine if new medical conditions or symptoms, which can represent new medical conditions, are related to anticoagulant or antiplatelet medication. Such conditions include cerebral hemorrhage, stroke or TIA, excessive bleeding to include gastrointestinal bleeding, and internal or external bleeding from trauma.

Patient Encounters Nurses must also observe and question patients who are on blood thinners during patient encounters including sick-call visits, chronic care visits, medication administration and diagnostic testing. The nurse should ask whether the patient is experiencing any of the following: blood in stool, severe bruising, prolonged and/or frequent nosebleeds, vomiting or coughing up blood and, in females, excessive vaginal bleeding. The nurse should document these symptoms or lack thereof. Notification to a clinician can be based on the patient’s appearance, complaints and vital signs. Remember to incorporate all information about your patient with each encounter or complaint. Document the complaint, signs and symptoms, the events of the complaint, currentCorrect medications the patient is on and what Publication: Care (NCCHC) size:1/2 vertical page, 4c, 4.5 x 9.87” actionsAdyou provided. Confirmed cost of: $2,300.00 Finally, nurses, especially in the correctional health care November Due arena, Run mustDate: educate patients2014 with2014, regard to 9/25 the medication prescribed, the potential side effects, when to report Contact at CCHCS: [email protected] those side effects to a member of the medical staff and the Approved by: [email protected] importance of medication compliance.

Designer at CCHCS: [email protected] Vendor Contact: Carmela Barhany Susan Laffan, CCHP-RN, CCHP-A, is a co-owner of SubmitRN, ad to: [email protected] Paid by: Invoice Specialized Medical Consultants, Toms River, NJ, and has

provided nursing care in emergency departments, critical care transport and correctional settings for more than 30 years. She may be reached at [email protected].

Exceptional Careers in an

UNEXPECTED PLACE

California Correctional Health Care Services embarked on a mission eight years ago to improve health care in our state’s correctional facilities.

We have made enormous progress, in large part by hiring exceptional clinicians like you. We provide a safe environment, where practitioners work with complete assurance of their well-being.

Staff Psychiatrist

$233,196/starting annual salary

Physician & Surgeon

$240,456/starting annual salary (Lifetime Board Certified)

$253,140/starting annual salary (Time-Limited Board Certified)

Nurse Practitioner

$110,940/starting annual salary What we offer is an exceptional lifestyle: Great pay • Awesome benefits • Retirement vests in 5 years • Work locations throughout California Paid insurance, license, and DEA renewal

M e d C a re e rs @ c d c r. c a . g o v 1.877.793.HIRE (4473) For more information or to apply online, please visit: www.changingprisonhealthcare.org

CALIFORNIA CORRECTIONAL

HEALTH CARE SERVICES EOE

15 www.ncchc.org


Each year, an estimated 1 IN 7 PERSONS living with HIV pass through a correctional facility1

For many patients, KALETRA in combination therapy may offer long-term efficacy against HIV* * Undetectable HIV-1 RNA ( 750 9% 1% 29% 3% 6% Triglycerides mg/dL Amylase > 2 x 3% 2% 4% N/A N/A ULN Lipase >2x N/A N/A N/A 3% 5% ULN Chemistry Low Calculated < 50 N/A N/A N/A 2% 2% Creatinine mL/ Clearance min HemaLow tology 1% 3% 5% 2% 1% Neutro5x ULN (AST/ALT). Table 4. Grade 3-4 Laboratory Abnormalities Reported in ≥ 2% of Adult Protease Inhibitor-Experienced Patients Study 888 Study 9572 Study 802 (48 Weeks) and Study (48 Weeks) 765 3 (84-144 Weeks) Variable Limit1 KALETRA Investigator- KALETRA KALETRA KALETRA 400/ Selected Twice 800/ 400/ 100 mg Protease Daily 200 mg 100 mg Twice Inhibitor(s) + NNRTI Once Twice Daily + NVP + NRTIs Daily Daily + NVP + NRTIs (N = 127) + NRTIs + NRTIs + NRTIs (N = 140) (N=300) (N=299) (N = 148) Chemistry High Glucose >250 1% 2% 5% 2% 2% mg/dL Total >3.48 1% 3% 1% 1% 1% Bilirubin mg/dL >180 5% 11% 8% 3% 2% SGOT/ U/L AST4 >215 6% 13% 10% 2% 2% SGPT/ U/L ALT4 GGT >300 N/A N/A 29% N/A N/A U/L Total >300 20% 21% 39% 6% 7% Cholesterol mg/dL Tri>750 25% 21% 36% 5% 6% glycerides mg/dL Amylase >2 x 4% 8% 8% 4% 4% ULN Lipase >2 x N/A N/A N/A 4% 1% ULN Creatine >4 x N/A N/A N/A 4% 5% Phospho- ULN kinase Chemistry Low Calculated 300 mg/dL 3% Amylase > 2.5 x ULN 7%2 Chemistry Low Sodium < 130 mEq/L 3% Hematology Low 9 Platelet Count < 50 x 10 /L 4% Neutrophils < 0.40 x 109/L 2% 1 ULN = upper limit of the normal range. 2 Subjects with Grade 3-4 amylase confirmed by elevations in pancreatic amylase. Postmarketing Experience The following adverse reactions have been reported during postmarketing use of KALETRA. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to KALETRA exposure. Body as a Whole Redistribution/accumulation of body fat has been reported [see Warnings and Precautions]. Cardiovascular Bradyarrhythmias. First-degree AV block, second-degree AV block, third-degree AV block, QTc interval prolongation, torsades (torsade) de pointes [see Warnings and Precautions]. Skin and Appendages Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome and erythema multiforme. DRUG INTERACTIONS See also Contraindications, Warnings and Precautions Potential for KALETRA to Affect Other Drugs Lopinavir/ritonavir is an inhibitor of CYP3A and may increase plasma concentrations of agents that are primarily metabolized by CYP3A. Agents that are extensively metabolized by CYP3A and have high first pass metabolism appear to be the most susceptible to large increases in AUC (> 3-fold) when co-administered with KALETRA. Thus, co-administration of KALETRA with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring as shown in Table 6. Additionally, KALETRA induces glucuronidation. Potential for Other Drugs to Affect Lopinavir Lopinavir/ritonavir is a CYP3A substrate; therefore, drugs that induce CYP3A may decrease lopinavir plasma concentrations and reduce KALETRA’s therapeutic effect. Although not observed in the KALETRA/ketoconazole drug interaction study, co-administration of KALETRA and other drugs that inhibit CYP3A may increase lopinavir plasma concentrations. Established and Other Potentially Significant Drug Interactions Table 6 provides a listing of established or potentially clinically significant drug interactions. Alteration in dose or regimen may be recommended based on drug interaction studies or predicted interaction.

Ad unit Project # must match this project # 045-1406308

Table 6. Established and Other Potentially Significant Drug Interactions Concomitant Effect on Clinical Comments Drug Class: Concentration Drug Name of Lopinavir or Concomitant Drug HIV-1 Antiviral Agents HIV-1 Protease An increased rate of adverse ↓ amprenavir Inhibitor: reactions has been observed with co↓ lopinavir fosamprenavir/ administration of these medications. ritonavir Appropriate doses of the combinations with respect to safety and efficacy have not been established. HIV-1 Protease Decrease indinavir dose to 600 mg ↑ indinavir Inhibitor: indinavir* twice daily, when co-administered with KALETRA 400/100 mg twice daily KALETRA once daily has not been studied in combination with indinavir. HIV-1 Protease KALETRA should not be administered ↑ nelfinavir Inhibitor: ↑ M8 metabolite once daily in combination with nelfinavir* nelfinavir. of nelfinavir ↓ lopinavir HIV-1 Protease Appropriate doses of additional ↑ lopinavir Inhibitor: ritonavir* ritonavir in combination with KALETRA with respect to safety and efficacy have not been established. HIV-1 Protease The saquinavir dose is 1000 mg twice ↑ saquinavir Inhibitor: daily, when co-administered with saquinavir* KALETRA 400/100 mg twice daily. KALETRA once daily has not been studied in combination with saquinavir. KALETRA should not be administered HIV-1 Protease ↓ lopinavir AUC with tipranavir (500 mg twice daily) Inhibitor: tipranavir and Cmin co-administered with ritonavir (200 mg twice daily). HIV CCR5 – Concurrent administration of maraviroc ↑ maraviroc Antagonist: with KALETRA will increase plasma maraviroc levels of maraviroc. When coadministered, patients should receive 150 mg twice daily of maraviroc. For further details see complete prescribing information for Selzentry® (maraviroc). Non-nucleoside KALETRA dose increase is ↓ lopinavir Reverse recommended in all patients. Transcriptase Increasing the dose of KALETRA Inhibitors: tablets to 500/125 mg (given as two efavirenz*, 200/50 mg tablets and one 100/25 mg nevirapine* tablet) twice daily co-administered with efavirenz resulted in similar lopinavir concentrations compared to KALETRA tablets 400/100 mg (given as two 200/50 mg tablets) twice daily without efavirenz. Increasing the dose of KALETRA tablets to 600/150 mg (given as three 200/50 mg tablets) twice daily coadministered with efavirenz resulted in significantly higher lopinavir plasma concentrations compared to KALETRA tablets 400/100 mg twice daily without efavirenz. KALETRA should not be administered once daily in combination with efavirenz or nevirapine. Non-nucleoside Appropriate doses of the combination ↑ lopinavir Reverse with respect to safety and efficacy Transcriptase have not been established. Inhibitor: delavirdine Nucleoside KALETRA tablets can be administered Reverse simultaneously with didanosine Transcriptase without food. Inhibitor: For KALETRA oral solution, it is didanosine recommended that didanosine be administered on an empty stomach; therefore, didanosine should be given one hour before or two hours after KALETRA oral solution (given with food). Nucleoside KALETRA increases tenofovir ↑ tenofovir Reverse concentrations. The mechanism of Transcriptase this interaction is unknown. Patients Inhibitor: tenofovir receiving KALETRA and tenofovir should be monitored for adverse reactions associated with tenofovir. Nucleoside KALETRA induces glucuronidation; ↓ abacavir Reverse therefore, KALETRA has the potential ↓ zidovudine Transcriptase to reduce zidovudine and abacavir Inhibitors: plasma concentrations. The clinical abacavir significance of this potential interaction zidovudine is unknown. Other Agents Antiarrhythmics ↑ antiarrhythmics Caution is warranted and therapeutic e.g.: concentration monitoring (if available) amiodarone, is recommended for antiarrhythmics bepridil, when co-administered with KALETRA. lidocaine (systemic), quinidine (continued)

Table 6

Table 6

continued

Concomitant Drug Class: Drug Name

Effect on Clinical Comments Concentration of Lopinavir or Concomitant Drug Other Agents Anticancer Agents: ↑ anticancer Concentrations of these drugs may vincristine, be increased when co-administered agents vinblastine, with KALETRA resulting in the potential dasatinib, for increased adverse events usually nilotinib associated with these anticancer agents. For vincristine and vinblastine, consideration should be given to temporarily withholding the ritonavircontaining antiretroviral regimen in patients who develop significant hematologic or gastrointestinal side effects when KALETRA is administered concurrently with vincristine or vinblastine. If the antiretroviral regimen must be withheld for a prolonged period, consideration should be given to initiating a revised regimen that does not include a CYP3A or P-gp inhibitor. A decrease in the dosage or an adjustment of the dosing interval of nilotinib and dasatinib may be necessary for patients requiring co-administration with strong CYP3A inhibitors such as KALETRA. Please refer to the nilotinib and dasatinib prescribing information for dosing instructions. Anticoagulants: Concentrations of warfarin may be ↑ rivaroxaban warfarin, affected. It is recommended that INR rivaroxaban (international normalized ratio) be monitored. Avoid concomitant use of rivaroxaban and KALETRA. Co-administration of KALETRA and rivaroxaban is expected to result in increased exposure of rivaroxaban which may lead to risk of increased bleeding. Anticonvulsants: ↓ lopinavir KALETRA may be less effective carbamazepine, ↓ phenytoin due to decreased lopinavir plasma phenobarbital, concentrations in patients taking these phenytoin agents concomitantly and should be used with caution. KALETRA should not be administered once daily in combination with carbamazepine, phenobarbital, or phenytoin. In addition, co-administration of phenytoin and KALETRA may cause decreases in steady-state phenytoin concentrations. Phenytoin levels should be monitored when coadministering with KALETRA. Anticonvulsants: ↓ lamotrigine Co-administration of KALETRA lamotrigine, ↓ or ↔ valproate and lamotrigine or valproate valproate may decrease the exposure of lamotrigine or valproate. A dose increase of lamotrigine or valproate may be needed when co-administered with KALETRA and therapeutic concentration monitoring for lamotrigine may be indicated; particularly during dosage adjustments. Antidepressant: Concurrent administration of bupropion ↓ bupropion bupropion with KALETRA may decrease plasma ↓ active levels of both bupropion and its metabolite, active metabolite (hydroxybupropion). hydroxyPatients receiving KALETRA and bupropion bupropion concurrently should be monitored for an adequate clinical response to bupropion. Antidepressant: Concomitant use of trazodone and ↑ trazodone trazodone KALETRA may increase concentrations of trazodone. Adverse reactions of nausea, dizziness, hypotension and syncope have been observed following co-administration of trazodone and ritonavir. If trazodone is used with a CYP3A4 inhibitor such as ritonavir, the combination should be used with caution and a lower dose of trazodone should be considered. Anti-infective: ↑ clarithromycin For patients with renal impairment, the clarithromycin following dosage adjustments should be considered: • For patients with CLCR 30 to 60 mL/min the dose of clarithromycin should be reduced by 50%. • For patients with CLCR < 30 mL/min the dose of clarithromycin should be decreased by 75%. No dose adjustment for patients with normal renal function is necessary. (continued)

continued


Effect on Clinical Comments Concentration of Lopinavir or Concomitant Drug Other Agents Antifungals: High doses of ketoconazole ↑ ketoconazole ketoconazole*, (>200 mg/day) or itraconazole ↑ itraconazole itraconazole, (> 200 mg/day) are not recommended. ↓ voriconazole voriconazole Co-administration of voriconazole with KALETRA has not been studied. However, a study has been shown that administration of voriconazole with ritonavir 100 mg every 12 hours decreased voriconazole steady-state AUC by an average of 39%; therefore, co-administration of KALETRA and voriconazole may result in decreased voriconazole concentrations and the potential for decreased voriconazole effectiveness and should be avoided, unless an assessment of the benefit/ risk to the patient justifies the use of voriconazole. Otherwise, alternative antifungal therapies should be considered in these patients. Anti-gout: Patients with renal or hepatic ↑ colchicine colchicine impairment should not be given colchicine with KALETRA. Treatment of gout flares-coadministration of colchicine in patients on KALETRA: 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (half tablet) 1 hour later. Dose to be repeated no earlier than 3 days. Prophylaxis of gout flares-coadministration of colchicine in patients on KALETRA: If the original colchicine regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg once a day. If the original colchicine regimen was 0.6 mg once a day, the regimen should be adjusted to 0.3 mg once every other day. Treatment of familial Mediterranean fever (FMF)-co-administration of colchicine in patients on KALETRA: Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a day). Antimycobacterial: ↑ rifabutin Dosage reduction of rifabutin by at least 75% of the usual dose of and rifabutin rifabutin* 300 mg/day is recommended (i.e., metabolite a maximum dose of 150 mg every other day or three times per week). Increased monitoring for adverse reactions is warranted in patients receiving the combination. Further dosage reduction of rifabutin may be necessary. Antimycobacterial: ↓ lopinavir May lead to loss of virologic response rifampin and possible resistance to KALETRA or to the class of protease inhibitors or other co-administered antiretroviral agents. A study evaluated combination of rifampin 600 mg once daily, with KALETRA 800/200 mg twice daily or KALETRA 400/100 mg + ritonavir 300 mg twice daily. Pharmacokinetic and safety results from this study do not allow for a dose recommendation. Nine subjects (28%) experienced a ≥ grade 2 increase in ALT/AST, of which seven (21%) prematurely discontinued study per protocol. Based on the study design, it is not possible to determine whether the frequency or magnitude of the ALT/AST elevations observed is higher than what would be seen with rifampin alone. Antiparasitic: Clinical significance is unknown; ↓ atovaquone atovaquone however, increase in atovaquone doses may be needed. Benzodiazepines: ↑ midazolam Midazolam is extensively metabolized parenterally by CYP3A4. Increases in the administered concentration of midazolam are midazolam expected to be significantly higher with oral than parenteral administration. Therefore, KALETRA should not be given with orally administered midazolam [see Contraindications]. If KALETRA is co-administered with parenteral midazolam, close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised and dosage adjustment should be considered. Contraceptive: ↓ ethinyl estradiol Because contraceptive steroid ethinyl estradiol* concentrations may be altered when KALETRA is co-administered with oral contraceptives or with the contraceptive patch, alternative methods of nonhormonal contraception are recommended. (continued)

Ad unit Project # must match this project # 045-1406308

Table 6

Table 6

continued


Corticosteroids (systemic): e.g. budesonide, dexamethasone, prednisone

Dihydropyridine Calcium Channel Blockers: e.g. felodipine, nifedipine, nicardipine Disulfiram/ metronidazole

Effect on Clinical Comments Concentration of Lopinavir or Concomitant Drug Other Agents Use with caution. KALETRA may ↓ lopinavir ↑ glucocorticoids be less effective due to decreased lopinavir plasma concentrations in patients taking these agents concomitantly. Concomitant use may result in increased steroid concentrations and reduced serum cortisol concentrations. Concomitant use of glucocorticoids that are metabolized by CYP3A, particularly for long-term use, should consider the potential benefit of treatment versus the risk of systemic corticosteroid effects. Concomitant use may increase the risk for development of systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. ↑ dihydropyridine Caution is warranted and calcium channel clinical monitoring of patients is recommended. blockers

Endothelin Receptor Antagonists: bosentan

↑ bosentan

HCV-Protease Inhibitor: boceprevir

↓ lopinavir ↓ boceprevir ↓ ritonavir

HCV-Protease Inhibitor: telaprevir

↓ telaprevir ↔ lopinavir

HMG-CoA Reductase Inhibitors: atorvastatin rosuvastatin

↑ atorvastatin ↑ rosuvastatin

Immuno↑ immunosuppressants: e.g. suppressants cyclosporine, tacrolimus, sirolimus Inhaled or ↑ glucocorticoids Intranasal Steroids e.g.: fluticasone, budesonide

Long-acting ↑ salmeterol beta-adrenoceptor Agonist: salmeterol

KALETRA oral solution contains alcohol, which can produce disulfiramlike reactions when co-administered with disulfiram or other drugs that produce this reaction (e.g., metronidazole). Co-administration of bosentan in patients on KALETRA: In patients who have been receiving KALETRA for at least 10 days, start bosentan at 62.5 mg once daily or every other day based upon individual tolerability. Co-administration of KALETRA in patients on bosentan: Discontinue use of bosentan at least 36 hours prior to initiation of KALETRA. After at least 10 days following the initiation of KALETRA, resume bosentan at 62.5 mg once daily or every other day based upon individual tolerability. It is not recommended to coadminister KALETRA and boceprevir. Concomitant administration of KALETRA and boceprevir reduced boceprevir, lopinavir and ritonavir steady-state exposures. It is not recommended to coadminister KALETRA and telaprevir. Concomitant administration of KALETRA and telaprevir reduced steady-state telaprevir exposure, while the steady-state lopinavir exposure was not affected. Use atorvastatin with caution and at the lowest necessary dose. Titrate rosuvastatin dose carefully and use the lowest necessary dose; do not exceed rosuvastatin 10 mg/day. See Drugs with No Observed or Predicted Interactions with KALETRA for drug interaction data with other HMG-CoA reductase inhibitors. Therapeutic concentration monitoring is recommended for immunosuppressant agents when co-administered with KALETRA. Concomitant use of KALETRA and fluticasone or other glucocorticoids that are metabolized by CYP3A is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects. Concomitant use may result in increased steroid concentrations and reduce serum cortisol concentrations. Systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression have been reported during postmarketing use in patients when certain ritonavircontaining products have been co-administered with fluticasone propionate or budesonide. Concurrent administration of salmeterol and KALETRA is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.

(continued)

continued


Narcotic Analgesics: methadone,* fentanyl

PDE5 inhibitors: avanafil, sildenafil, tadalafil, vardenafil

Effect on Clinical Comments Concentration of Lopinavir or Concomitant Drug Other Agents Dosage of methadone may need to ↓ methadone be increased when co-administered ↑ fentanyl with KALETRA. Concentrations of fentanyl are expected to increase. Careful monitoring of therapeutic and adverse effects (including potentially fatal respiratory depression) is recommended when fentanyl is concomitantly administered with KALETRA. Do not use KALETRA with avanafil ↑ avanafil because a safe and effective avanafil ↑ sildenafil dosage regimen has not been ↑ tadalafil established. ↑ vardenafil Particular caution should be used when prescribing sildenafil, tadalafil, or vardenafil in patients receiving KALETRA. Co-administration of KALETRA with these drugs is expected to substantially increase their concentrations and may result in an increase in PDE5 inhibitor associated adverse reactions including hypotension, syncope, visual changes and prolonged erection. Use of PDE5 inhibitors for pulmonary arterial hypertension (PAH): Sildenafil (Revatio®) is contraindicated when used for the treatment of pulmonary arterial hypertension (PAH) because a safe and effective dose has not been established when used with KALETRA [see Contraindications]. The following dose adjustments are recommended for use of tadalafil (Adcirca®) with KALETRA: Co-administration of ADCIRCA in patients on KALETRA: In patients receiving KALETRA for at least one week, start ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability. Co-administration of KALETRA in patients on ADCIRCA: Avoid use of ADCIRCA during the initiation of KALETRA. Stop ADCIRCA at least 24 hours prior to starting KALETRA. After at least one week following the initiation of KALETRA, resume ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability. Use of PDE5 inhibitors for erectile dysfunction: It is recommended not to exceed the following doses: • Sildenafil: 25 mg every 48 hours • Tadalafil: 10 mg every 72 hours • Vardenafil: 2.5 mg every 72 hours Use with increased monitoring for adverse events.

Drugs with No Observed or Predicted Interactions with KALETRA Drug interaction or clinical studies reveal no clinically significant interaction between KALETRA and desipramine (CYP2D6 probe), pitavastatin, pravastatin, stavudine, lamivudine, omeprazole, raltegravir, or ranitidine. Based on known metabolic profiles, clinically significant drug interactions are not expected between KALETRA and dapsone, trimethoprim/sulfamethoxazole, azithromycin, erythromycin, or fluconazole. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Antiretroviral Pregnancy Registry: To monitor maternal-fetal outcomes of pregnant women exposed to KALETRA, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263. Human Data There are no adequate and well-controlled studies in pregnant women. KALETRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Antiretroviral Pregnancy Registry As of January 2011, the Antiretroviral Pregnancy Registry (APR) has received prospective reports of 2458 exposures to lopinavir containing regimens (738 exposed in the first trimester and 1720 exposed in the second and third trimester). Birth defects occurred in 16 of the 738 (2.2%) live births (first trimester exposure) and 41 of the 1720 (2.4%) live births (second/third trimester exposure). Among pregnant women in the U.S. reference population, the background rate of birth defects is 2.7%. There was no association between lopinavir and overall birth defects observed in the APR. Animal Data No treatment-related malformations were observed when lopinavir in combination with ritonavir was administered to pregnant rats or rabbits. Embryonic and fetal developmental toxicities (early resorption, decreased fetal viability, decreased fetal body weight, increased incidence of skeletal variations and skeletal ossification delays) occurred in rats at a maternally toxic dosage. Based on AUC measurements, the drug exposures in rats at the toxic doses were approximately 0.7-fold for lopinavir and 1.8-fold for ritonavir for males and females that of the exposures in humans at the recommended therapeutic dose (400/100 mg twice daily). In a peri- and postnatal study in rats, a developmental toxicity (a decrease in survival in pups between birth and postnatal Day 21) occurred.

No embryonic and fetal developmental toxicities were observed in rabbits at a maternally toxic dosage. Based on AUC measurements, the drug exposures in rabbits at the toxic doses were approximately 0.6-fold for lopinavir and 1.0-fold for ritonavir that of the exposures in humans at the recommended therapeutic dose (400/100 mg twice daily). Nursing Mothers The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Studies in rats have demonstrated that lopinavir is secreted in milk. It is not known whether lopinavir is secreted in human milk. Because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving KALETRA. Pediatric Use The safety, efficacy, and pharmacokinetic profiles of KALETRA in pediatric patients below the age of 14 days have not been established. KALETRA once daily has not been evaluated in pediatric patients. An open-label, multi-center, dose-finding trial was performed to evaluate the pharmacokinetic profile, tolerability, safety and efficacy of KALETRA oral solution containing lopinavir 80 mg/mL and ritonavir 20 mg/mL at a dose of 300/75 mg/m2 twice daily plus two NRTIs in HIV-infected infants ≥14 days and < 6 months of age. Results revealed that infants younger than 6 months of age generally had lower lopinavir AUC12 than older children (6 months to 12 years of age), however, despite the lower lopinavir drug exposure observed, antiviral activity was demonstrated as reflected in the proportion of subjects who achieved HIV-1 RNA 6 months of age was demonstrated in a clinical trial in 100 patients. The clinical trial was an open-label, multicenter trial evaluating the pharmacokinetic profile, tolerability, safety, and efficacy of KALETRA oral solution containing lopinavir 80 mg/mL and ritonavir 20 mg/mL in 100 antiretroviral naïve and experienced pediatric patients ages 6 months to 12 years. Dose selection for patients 6 months to 12 years of age was based on the following results. The 230/57.5 mg/m2 oral solution twice daily regimen without nevirapine and the 300/75 mg/m2 oral solution twice daily regimen with nevirapine provided lopinavir plasma concentrations similar to those obtained in adult patients receiving the 400/100 mg twice daily regimen (without nevirapine) [see Adverse Reactions]. A prospective multicenter, open-label trial evaluated the pharmacokinetic profile, tolerability, safety and efficacy of high-dose KALETRA with or without concurrent NNRTI therapy (Group 1: 400/100 mg/m2 twice daily + ≥ 2 NRTIs; Group 2: 480/120 mg/m2 twice daily + ≥ 1 NRTI + 1 NNRTI) in 26 children and adolescents ≥ 2 years to < 18 years of age who had failed prior therapy. Patients also had saquinavir mesylate added to their regimen. This strategy was intended to assess whether higher than approved doses of KALETRA could overcome protease inhibitor cross-resistance. High doses of KALETRA exhibited a safety profile similar to those observed in previous trials; changes in HIV-1 RNA were less than anticipated; three patients had HIV-1 RNA