Frequently Asked Questions
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Substance Abuse: 6:10 - 8:40 PM; Ross Hall 224) physiology of substance abuse and its treatment will be reviewed, with emphasis on the preventable complications and sequelae of the different stages of use, abuse and addiction. Substance abusers will be examined as a key population for biopsychosocial interventions to protect them, their families, communities and the general public. Various public health interventions will be explored at all possible points of contact with drug abusers, both in and out of treatment. Current national initiatives relevant to drug abusers and related public health issues will be reviewed.
Substance Abuse: Prevention, Intervention & Public Health (Public Health 209.27: 5/20/2009 - 7/22/2009; Wednesdays 6:10 - 8:40 PM; Ross Hall 224) COURSE DESCRIPTION: The epidemiology, pathology and physiology of substance abuse and its treatment will be reviewed, with emphasis on the preventable complications and sequelae of the different stages of use, abuse and addiction. Substance abusers will be examined as a key population for biopsychosocial interventions to protect them, their families, communities and the general public. Various public health interventions will be explored at all possible points of contact with drug abusers, both in and out of treatment. Current national initiatives relevant to drug abusers and related public health issues will be reviewed. PROFESSOR: Alan Trachtenberg, MD, MPH OFFICIAL COURSE SYLLABUS COURSE ANNOUNCEMENTS: Announcements will be placed here. Please try to check this area each Tuesday night or Wednesday morning. Any last minute changes to Wednesday evening's session will be posted, as will other current events at the intersection of substance abuse and public health and new resources for class use; FOR INSTANCE: 7/9/2009: SESSIONS 7-8 HANDOUT POSTED: SESSIONS 7-8: Addiction Treatment Slides 7/1/2009: CLASS PRESENTATIONS ASSIGNED- All students will be asked to present an informal 5-10 minute presentation on their final project during the 8th or 9th Class session, either 7/8/2009 or 7/15/2009. Presentations should contain all the main elements of the project, but no slides or handouts are expected. 6/29/2009: SESSION 5-6 HANDOUTS POSTED: SESSION 5-6: Drug Classes and Routes of Administration. 6/13/2009: NEW HANDOUT POSTED: Psychiatric & Behavioral Aspects of Alcohol & Drug Abuse; Initiation & Progression. 5/16/2009: EVIDENCE BASED PREVENTION INTERVENTIONS This searchable database (http://casat.unr.edu/bestpractices/search.php) includes interventions that have been shown to be effective in preventing substance abuse and/or the risk factors for substance abuse. Information is provided regarding training, technical assistance and/or materials that facilitate replication of each practice. Use the check boxes to indicate on which variable(s) you would like to conduct a search of evidence based drug prevention interventions. When you click the button near the bottom of the page ("Find Matching Practices"), an 'OR' search will be completed. Select as many attributes that interest you. The results will be ranked based on how many programs have attributes matching the criteria you specify. More resources for finding evidence-based prevention programs can be found at http://captus.samhsa.gov/national/resources/evidence_based.cfm.
7/31/2008: Differential brain changes documented in rats trained to self-administer cocaine, versus animals trained to self-administer natural rewards such as food: The brain changes due to cocaine training persisted for up to three months of abstinence, but the changes in response to natural rewards dissipated after only three weeks. Rats receiving cocaine only passively (whenever the other, trainee, rat pressed the lever) demonstrated neither transient nor long lasting changes, demonstrating the essential role of self-administration in causing the brain changes of addiction. See NIDA press release at http://www.nida.nih.gov/newsroom/08/NR7-31.html. TO CONTACT THE PROFESSOR (for GW or class business): Please call in the evenings: 301-984-8843; EMAIL using: 2create.yourMD@gmail.com; OR PREFERABLY: Please use the confidential web-based messaging function on the 2Create homepage (in the upper right-hand corner, you may have to scroll to the right to see it) or try going directly to the Sign Up New User Page . OUTSIDE OF CLASSROOM HOURS, questions on class content are best addressed on the 2Create Blog at: (http://2createyourmd.blogspot.com/) . This is intended to facilitate an ongoing, web-based class discussion for everyone to benefit from everyone else's questions. Email questions of a non-private nature will generally be answered on the Blog, or in class, rather than by reply email. Questions of a private nature will be received and answered via the web-based messaging function on the 2Create website. Remember that (as always) regular email is NEVER confidential. GRADING METHOD: Grading will be based on classroom participation, timely completion of assignments, one quiz, and a brief student paper on a public health or treatment program intervention against drug abuse or defined health consequence(s) of drug abuse. Optional assignments for extra credit will also be made available at the bottom of this page. REQUIRED READINGS: Links to all readings will be found on the class schedule below, underneath the session for which they are due. Please try to read them prior to that class session. OTHER ASSIGNMENTS: Are also noted on the class schedule below. Assigned work (other than reading) is due by the beginning of the class following when it was assigned. QUIZ: The quiz will be based on both the required readings and class sessions. The quiz format will be short answer, multiple choice and/or True/False type questions. The quiz will be difficult, but graded on a curve. FINAL PAPER: This can be thought of as kind of a mini-proposal, in which you will define a specific population and a health outcome relevant to the course (something to do with substance abuse and/or its sequelae) and propose an intervention to be applied to your defined population. The intervention should be expected to beneficially affect that outcome. Specifically, your paper must: 1) Justify the health outcome chosen (prevalence, morbidity, mortality, cost, etc.) as the target of the intervention; 2) Specify the population to whom you plan to apply your intervention, and how you will find/access/reach/identify them; 3) Give the rationale for the intervention, including a summary of the evidence base for it (How does it work? How well does it work?); 4) Describe the intervention, including the resources needed, target population, expected effectiveness, any risks involved and setting (pick a specific agency, program or institution from which you would be conducting the intervention); 5) Describe how the intervention could (and whether it should) be evaluated; 6) Include adequate references appropriate to the topic, with correctly formatted citations that contain adequate information for the reference to be retrievable by the reader from the primary source. (At least a few references are expected to the peer-reviewed literature. To ease their retrievability, weblinks to their abstracts in Medline or on the Journal site are appreciated. Citations from the popular press or ".com" websites are suitable for events or quotations, however, not for claims of scientific or biomedical evidence. Citations from other websites will be evaluated on an individual basis as to their credibility.); 7) Have correct spelling, punctuation and grammar; and 8) Be as long as necessary, but no longer than is necessary, to address items 1-6. You can choose anything from a prenatal or school-based program for primary prevention of drug abuse to a harm reduction intervention to a treatment-based tertiary prevention approach against HIV progression. You may want to approach the paper as if you are working in a particular agency that has some jurisdiction or mission related to the problem. For instance, a city public school system, an addiction treatment program or a state or county health department. Placing your project in an agency you have worked in or would like to work in might make your paper more relevant and interesting for you. OR, you can choose to place yourself wherever you can best conduct and/or evaluate the intervention in which you are most interested. EXAMPLES OF PREVIOUS PAPERS ARE POSTED AT: Papers on Public Health Interventions in Substance Abuse NOTE: Format, grammar, spelling and other aspects of the written presentation of your ideas are very important to the success of those ideas in the real world of public health and/or policy. Please take advantage of the GWU Writing Center if you have any potential concerns in these areas. The GWU Writing Center conducts free, one-on-one, 50-minute conferences with highly trained undergraduate and graduate students to assist you with course assignments, term papers, theses, applications, and resumes. They can help students at all stages of the writing process. The George Washington University Writing Center 550 Rome Hall; Phone: (202)994-3765 gwriter@gwu.edu (http://www.gwu.edu/~gwriter) DISCLAIMERS & DISCLOSURES: Professor Trachtenberg offers the following opinions, analyses and data under the doctrine of academic freedom; NOT as a representative of any agency with which he is, or may have ever been, associated. What follows is a synthesis of what I believe to be the most current materials from the best experts in the fields of addiction medicine and public health, as seen through the lenses of my own clinical and public health experience. All opinions are subject to change without notice. Stay tuned... CLASS SCHEDULE & ASSIGNMENTS: (Wednesday evenings, 6:10-8:40 PM. Attendance will be taken). Session 1 - 5/20/2009 Topics: Welcome, syllabus, introductions, disclaimers, overview of topic, neurophysiology and pharmacology of substance abuse. SYLLABUS OVERVIEW OF SUBSTANCE ABUSE IN PUBLIC HEALTH (handout for sessions 1 & 2) ASSIGNMENTS - Due by the beginning of session 2: 1. Establish username and password for confidential, HIPAA-compliant web-based messaging w/instructor at http://www.2create.yourmd.com/. See log-in area at upper right corner of front page (you may have to scroll to the right to see it) or try going directly to: sign up. Click on the instructor's name, then provide some basic information. Please do include Date of Birth (or at least Year of birth). Do not enter your social security number. Once you are registered, use the "general" message category to send the instructor a message with a couple of sentences about your particular interests in substance abuse or why you wanted to take this class. (Ignore the site's information on paid consultation; You have already paid GW.) 2. Carefully review the instructions for the final class paper and examine one or more examples of the previous class papers posted at: Papers on Public Health Interventions in Substance Abuse. Questions on these will be entertained at the beginning of session 2. Session 2 - 5/27/2009 Topics: Overview of drugs, drug classes, drug schedules, drug agencies and drug regulation in the US; Drug Abuse Epidemiology and History; Discussion of final projects. REQUIRED READING: Addiction as a Chronic Disorder; White WL and McClellan AT; http://www.comproviders.com/files/Addiction-as-a-Chronic-Disorder.pdf Comorbidity: Addiction and Other Mental Illnesses / NIDA 12/2008 (http://www.nida.nih.gov/researchreports/comorbidity/index.html) NIDA: Commonly Abused Drugs OR (local PDF of NIDA Table) Addiction Versus Dependence in DSM-V by O'Brien, Volkow & Li -Am J Psych 163:764-765, May 2006 OR (LOCAL PDF COPY) Drug Schedules and the Controlled Substances Act (CSA) pp 1-9 (http://www.usdoj.gov/dea/pubs/abuse/1-csa.htm) DEA Introduction to Drug Classes (Note: In general, DEA publications should be taken with a grain of salt,but these are not too bad.) "Narcotics" (Opioids, really: The term "Narcotics" is a legal one sometimesmisused interchangeably with "Opioids." [+/- cocaine]) Stimulants Depressants Cannabis Drugs of Abuse Chart "How Do They Measure Up?" Examining Drug Use Surveys and Statistics: Sources (Part 1) & Problems (Part 2) by Earth & Fire Erowid. (Erowid Extracts. Nov 2005; 9:12-21) OPTIONAL READING: Historical Themes in Chemical Prohibition By William L. White; From:Drugs in Perspective, National Institute on Drug Abuse, 1979 Session 3 - 6/3/2009 Topics: Overview of drugs, drug classes, drug schedules, drug agencies and drug regulation in the US; Drug Abuse Epidemiology and History (continued); Sources of data and information on substance abuse in the US; Resources for Online Data Analysis of Drug Abuse Related Data. REQUIRED READINGS: NIDA 2007 Publication: Drugs, Brains, and Behavior - The Science of Addiction OR (Local PDF: The Science of Addiction; NIDA 2007) NIDA Research Report: Hallucinogens and Dissociative Drugs. Pathology of Drug Abuse (NOTE: The statement in this reading about MDMA causing brain damage is unsubstantiated)(http://library.med.utah.edu/WebPath/TUTORIAL/DRUG/DRUG.html) NIDA Research Report: Prescription Drugs: Abuse and Addiction. NIDA Research Report: Inhalant Abuse. OPTIONAL READING: A Drug War Carol: the History of American Drug Control in Comic Book Form FDA, DEA and the Drug Approval & Scheduling Process Session 4 - 6/10/2009 QUIZ on readings for this week and 1st three classes. Topic: Epidemiology and Medical Complications of Drug Abuse. REQUIRED READING: Underage Drinking: Frequency, Consequences, and Interventions by RW Hingson et al (Traffic Injury Prevention 5:228-36, 2004). Medical Consequences Of Substance Abuse by MD Stein in Psychiatric Clinics of North America; June, 1999. 22(2):351-70. Managing Addiction as a Chronic Condition by M Dennis & CK Scott: NIDA Addiction Science & Clinical Practice 4(1) 45-55 (http://www.drugabuse.gov/ascp/vol4no1.html). Public Health and Injection Drug Use. MMWR 5/18/2001 Vol 50, No MM19;377 Epidemiology of HIV/AIDS --- United States, 1981--2005MMWR 6/2/2006 Vol 55, No MM21;589 CSAT Treatment Advisory: Anabolic Steroids. OPTIONAL READING: Preventable Causes of Death in the United States. Danaei et al (2009).(http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000058) ASSIGNMENT for session 5: Use the web-based messaging function to send the instructor your proposed topic for the final paper and receive a reply with your quiz grade. Your topic proposal should specifically describe: 1) The intervention you plan to apply; 2) The population you plan to apply it to and how you will find/access/reach them; 3) The health outcome you plan to prevent/affect & how you will measure it; and 4) Categorize your outcome intervention as universal, selective, indicated and/or primary, secondary or tertiary prevention. Session 5 - 6/17/2009 Topics: Epidemiology and Medical Complications of Drug Abuse (continued); Discussion of paper topics. REQUIRED READING: Alcoholism and Substance Abuse by Donald Warne (chapter from Rakel's INTEGRATIVE MEDICINE, 2nd Edition, 2007). Increasing deaths from opioid analgesics in the United States by Paulozzi et al (pharmacoepidemiology and drug safety 2006; 15: 618-27). CDC Fact Sheets on Substance Abuse Treatment: 6 items, 22 pages total OPTIONAL READING: Nestler E: The Neurobiology of Cocaine Addiction.NIDA Science & Practice Perspectives Volume 3, Number 1 - December 2005 Ira Marion: Methadone Treatment at Forty Neurobiology of Opioid Dependence-Implications for Treatment Session 6 - 6/24/2009 Topics: Substance Abuse Treatment and Prevention; Discussion of paper topics. REQUIRED READING: NIDA: Principles of Drug Addiction Treatment: A Research Based Guide NIAAA Alcohol Alert #66: Brief Interventions (2005) [ PDF ] National Voluntary Consensus Standards for the Treatment of Substance Use Conditions: Evidence-Based Treatment Practices (National Quality Forum) (http://www.qualityforum.org/pdf/reports/sud/sudexesummary.pdf) OR LOCAL PDF COPY NIDA Research Report: Therapeutic Community. 12-Step Participation as a Pathway to Recovery OPTIONAL READING: Principles of Drug Abuse Treatment for CRIMINAL JUSTICE POPULATIONS:A Research Based Guide Session 7 - 7/1/2009 Topics: Substance Abuse Treatment and Prevention (continued). REQUIRED READING: NIDA: Preventing Drug Abuse among Children and Adolescents, A Research Based Guide Safety First: A Reality-Based Approach to Teens and Drugs; by Dr. Marsha Rosenbaum OR http://www.safety1st.org/images/stories/pdf/safetyfirst.pdf Session 8 - 7/8/2009 Topics: Substance Abuse Treatment and Prevention (continued); Drug testing; Harm reduction. Discussion of extra credit requests. REQUIRED READING: CDC: Access to Sterile Syringes CDC: Syringe Disinfection for Injection Drug Users CDC: Drug Users and the Structure of the Criminal Justice System, August 2001 CDC: Women, Injection Drug Use, and the Criminal Justice System; August 2001 Testing Drugs vs. Testing For Drug Use: Private Risk Management In The Shadow Of The Criminal Law by Dr. Robert MacCoun. OR (LOCAL PDF COPY) ASSIGNMENT: CLASS PRESENTATIONS ASSIGNED - All students will be asked to present an informal 5-10 minute presentation on their final project during the 8th or 9th Class session, either 7/8/2009 or 7/15/2009. Presentations should contain all the main elements of the project, but no slides or handouts are expected. Session 9 -7/15/2009 Topics: Harm Reduction; Drug Policy. REQUIRED READING: Drug Use Prevention & Education (And Comments on DARE) by Dr. Jeff Ratliff-Crain OPTIONAL READING: Beyond Zero Tolerance: A comprehensive, cost-effective approach to high school drug education and student assistance Session 10 - 7/22/2009 Topics of special class interest; Evaluations; Turn in final papers; Fond farewells... Extra Credit Exercises for the Student: 1. Psychosis After Ultrarapid Detox & Switch Methadone to Hydrocodone for 12 Days / SHREERAM, McDONALD & DENNISON; Falls Church, VA 2. Use online data analysis of drug abuse related data from 1-3 primary sources (surveys or datasets) to make an interesting point or support a hypothesis about the epidemiology of substance abuse or it's consequences. Twice as much credit for using 2 sources and three times as much for using three such sources (for supporting the same point). Document your work with URLs used and copies or screen shots of relevant search strategies and results. Other web-based data may also be used to support the arguments from your online data analysis. Examples of sources to use can be found at: Resources for Online Data Analysis of Drug Abuse Related Data. Final product should be emailed to the instructor. Exemplary Papers on Substance Abuse &Public Health The following are exemplary papers that were turned in as final projects for Public Health 290.20-A GW Topics Course on Substance Abuse: Prevention, Intervention and Public Health. They are posted by Dr. Trachtenberg, the instructor, with permission of the authoring students, as examples of excellent content, format and style; and to serve as models for other students of good graduate-level writing on substance abuse topics. Development and Implementation of a Sexual Assault and Alcohol Abuse Education Prevention Program Targeting Greek Organizations on the GWU Campus By Alison Shaffer (Summer 2007) Utilizing Youth Possession Laws to Decrease the Prevalence of Youth Cigarette Smoking by Jeremy Drehmer (Summer, 2007) Implementing a Hepatitis B Program for Injecting Drug Users Under Age 30 Through a Needle Exchange Program (Author's Name Withheld by Request) Teaching Social Resistance Skills and Building Self-efficacy: A Primary Prevention Approach to Reducing Drug-Related Morbidity in Adolescents (Author's Name Withheld by Request) Phantom NIDA Research Monograph 169 on Pain Monograph on Pain Treatment in Patients W/Histories of Drug Dependence Exemplary Papers on Substance Abuse &Public Health The following are exemplary papers that were turned in as final projects for Public Health 290.20-A GW Topics Course on Substance Abuse: Prevention, Intervention and Public Health. They are posted by Dr. Trachtenberg, the instructor, with permission of the authoring students, as examples of excellent content, format and style; and to serve as models for other students of good graduate-level writing on substance abuse topics. Development and Implementation of a Sexual Assault and Alcohol Abuse Education Prevention Program Targeting Greek Organizations on the GWU Campus By Alison Shaffer (Summer 2007) Utilizing Youth Possession Laws to Decrease the Prevalence of Youth Cigarette Smoking by Jeremy Drehmer (Summer, 2007) Implementing a Hepatitis B Program for Injecting Drug Users Under Age 30 Through a Needle Exchange Program (Author's Name Withheld by Request) Teaching Social Resistance Skills and Building Self-efficacy: A Primary Prevention Approach to Reducing Drug-Related Morbidity in Adolescents (Author's Name Withheld by Request) Phantom NIDA Research Monograph 169 on Pain Monograph on Pain Treatment in Patients W/Histories of Drug Dependence CONTENTS / Alan I. Trachtenberg, M.D., M.P.H. Introduction / Alan I. TrachtenbergAssessment of Addiction in Chronic Pain Patients on Long-Term Opioids / Karen L. Sees and H. Westley Clark Alternative Medicine: Expanding Medical HorizonsAlternative Medicine: Expanding Medical Horizons (NIH/OAM's "Chantilly Report") A Report to the NIH on Alternative Medical Systems and Practices in the USA / Workshop on Alternative Medicine, Chantilly, VAForeword / Brian M. Berman, MD & David B. Larson, MD, MPHPART I: FIELDS OF PRACTICE: _ ___________ _ _ _ 1)Mind/Body Interventions / .2)Bioelectromagnetics Applications in Medicine / .3)Alternative Systems of Medical Practice / .4)Manual Healing Methods / .5)Pharmacological and Biological Treatments / .6)Herbal Medicine / .7)Diet and Nutrition in the Prevention and Treatment of Chronic Disease / .PART II: CONDUCTING AND DISSEMINATING RESEARCH / .PART III: CONCLUSION, APPENDIXES, GLOSSARY, AND INDEX / . Evidence Based Medicine (EBM) Epidemiology Coggon, D., Rose, G., and Barker, D. J. P. (1997). Epidemiology for the uninitiated. BMJ Publishing Group.This epidemiology primer offers a straightforward and jargon-free introduction to the principles of epidemiology. Though the book focuses primarily on the application of epidemiology in the healthcare setting, these concepts translate easily to public health applications, as well. Evaluation Schwandt, T. A. (2005). The centrality of practice to evaluation. American Journal of Evaluation, 26 (1): 95 - 105.This article discusses two different ways in which notions of evidence based, practice, and evaluation are related and suggests what a genuinely practice-oriented approach to evaluation entails. Evidence Based Medicine Tool Kit / WebLinkCenter for Evidence Based Medicine / WebLinkAAFP on Prevention of Antibiotic Resistance / WebLinkScreening Test Recommendations / WebLinkClinical Epidemiology & Evidence-Based Medicine Glossary / WebLinkU of Utah DFPM Evidence-Based Medicine Search Site / WebLinkTools for Public Health Professionals / WebLinkGetting NIH Grants / WebLinkGrantsNet / WebLinkGo To The Source: Medline/Pubmed / WebLinkProtecting Research Subjects/Patients / WebLinkAAAS Links to Scientific Institutions / WebLinkAAAS Links to Peer-Reviewed Journals / WebLinkAAAS Links to Science Media / WebLinkAdverse Events: LASER Eye Surgery / WebLinkMore on LASER Eye Surgery Adverse Events / WebLinkCochrane Collaboration for Systematic Reviews / WebLinkIndex to Cochrane Collaboration Reviews / WebLinkBMJ Clinical Evidence / WebLinkCentre for Evidence Based Mental Health / WebLinkInvestigating and dealing with Bias in Meta-Analysis (Sterne et al, BMJ) / WebLinkBMJ Full Text Collections / WebLinkLasik Eye Surgery at the Washington Post / WebLink Epidemiology Resources The Vaccine Page: Vaccine News and Database / WebLinkVaccine Adverse Event Reporting System / WebLinkOne World / Global Health / Diseases Know No Borders (DHHS site) / WebLinkErlanger Atopy Questionnaire: Calculates your personal 'Atopy-Score', i.e. calculates a probability / WebLinkThe eHealth Landscape: A Terrain Map of Emerging Info and CommTech in Health by T.R. Eng; RWJ, 2001 / WebLinkAIDS Education Global Information System (AEGIS) / WebLinkThe Promise of Vaccines: The Science and the Controversy from the American Council on Science & Health (ACSH) / WebLink WWW EPIDEMIOLOGY & BIOSTATISTICS RESOURCES (UCSF-BEST) EpiData is a comprehensive easy to use tool for simple or programmed data entry and for data Documentation. EpiData is free and is currently developed for windows 95/98/NT/2000/XP. Epidemiology - Lipincott, Williams & Wilkins (http://www.epidem.com/) "Unhygienic" entrances associated with Pasturella pestis? CDC Glossary of Epidemiologic Terminology: (http://www.cdc.gov/nccdphp/drh/epi_gloss.htm) NCHS Data Warehouse for Vital Statistics & national causes of death (http://www.cdc.gov/nchs/datawh/statab/unpubd/mortabs.htm) An alphabetical listing of many terms used at NCHS: (http://www.cdc.gov/nchs/datawh/nchsdefs/list.htm) Search all Federal Statistics sites: (http://search.fedstats.gov/) National Center for Health Statistics (NCHS) data systems and surveys: http://www.cdc.gov/nchs/express.htm Case Studies in Environmental Medicine (CSEM) by the Agency for Toxic Substances and Disease Registry (free CME from ATSDR) http://www.atsdr.cdc.gov/HEC/CSEM/ National Geographic MAP MACHINE:(http://plasma.nationalgeographic.com/mapmachine/) Chronic Pain Wisconsin Pain Initiative (Best pain/policy site on the web) / WebLinkDon't worry about using opioids for pain relief / WebLinkSample Contract for Controlled Substance Prescriptions / Dr. Weaver, MCVMedscape Pain Resource Center / WebLinkThe Liebeskind History Of Pain Collection at UCLA / WebLinkPain and Palliative Care Reporter / WebLinkEnd of Life Physician Education Resource Center (EPERC) / WebLinkPublic Policy of ASAM: Definitions Related to the Use of Opioids for the Treatment of Pain / ASAMPublic Policy of ASAM: Rights and Responsibilities of Physicians in the Use of Opioids for the Treatment of Pain / ASAMAmerican Pain Foundation / WebLinkRoxane Pain Institute / WebLinkPain Specialists and Addiction Medicine Specialists Unite to Address Critical Issues (APS Bulletin MARCH/APRIL 1999) / WebLinkPartners Against Pain Prof. Education (Purdue) / WebLinkWeb-based Interactive Textbook on Pain and Clinical Research from NIH / WebLinkChronic Pain In America: Roadblocks To Relief: Survey Results from the American Pain Society (APS) / WebLinkNational Pain Care Policy Act of 2001 Draft Bill / WebLinkWeb Sites for those with Arachnoiditis / WebLinkOxycontin Hearings by the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations, 8/28/2001 / WebLinkTopics In Pain Management Slide Compendium from Beth Israel (NYC) Dept of Pain Medicine & Palliative Care / WebLink Monograph on Pain Treatment in Patients W/Histories of Drug DependenceCONTENTS / Alan I. Trachtenberg, M.D., M.P.H.001 Introduction / Alan I. TrachtenbergAssessment of Addiction in Chronic Pain Patients on Long-Term Opioids / Karen L. Sees and H. Westley ClarkExtent of Drug Abuse and Addiction in Chronic Pain Patients / D Fishbain, H & RS Rosomoff, M Goldberg, R CutlerUse of Opioids in Treatment of Chronic Pain: Physicians' Attitudes & Practices / Dennis C. TurkPain in the Context of Drug Abuse / Margaret ComptonPain in AIDS: Substance Abuse Issues / William Breitbart, SD Passik, and MV McDonaldOpioid Therapy for Chronic Noncancer Pain / Russell K. PortenoyPolicy Issues & Imperatives in the Use of Opioids To Treat Pain in Drug Abusers / David E. Joranson and Aaron M. GilsonPain Without Treatment, Wrong Without Remedy: Implications of the ADA / William E. HurwitzMedical Education for Pain & Addiction: Making Progress Toward Answering a Need / Sidney H. Schnoll and James FinchNonopioid Treatment of Pain in Addiction / Seddon R. SavageOpioid Analgesia for Chronic Noncancer Pain: Practical Management Issues / RL Brown, MF Fleming,JJ Patterson, AI Trachtenberg ASAM Pain & addiction definitions and related Pain Pages Pain & the Law Website at the Center for Health Law Studies at Saint Louis University and the American Society of Law, Medicine and Ethics under a grant from The Mayday Fund. http://www.painandchemicaldependency.org/blast1.htm Federal regulations regarding the prescribing of controlled substances can be found by going to the Code of Federal Regulations Website at www.access.gpo.gov/nara/cfr/index.html and entering (in quotes) "21CFR1306.03." Federal regulations regarding the prescribing of controlled substances can be found by going to the Code of Federal Regulations Website at www.access.gpo.gov/nara/cfr/index.html and entering (in quotes) "21CFR1306.03." International Association for Hospice and Palliative Care The American Society of Interventional Pain Physicians "The Voice of Interventional Pain Medicine." Mission: To promote the development and practice of safe, high quality, cost-effective interventional pain medicine techniques for the diagnosis and treatment of pain and related disorders, and to ensure patient access to these interventions. Issues Impacting the Pharmaceutical Industry SMi/Datamonitor (March 2001) The diagnosis of pain severely impacts the course and amount of analgesic medication patients will receive during treatment. Therefore, the problems in assessing pain severity, coupled with continued physician ignorance about the entire pain management process, will damage pharmaceutical revenues. This Brief analyzes key issues in pain diagnosis and suggests options for improving revenues by highlighting physician issues about pain diagnosis, management and the use of opioids, the increasing role of nurses in the diagnosis process, the impact of patients in the pain management procedure, the potential impact of new regulations on pharmaceutical revenues, recommendations about the specific healthcare providers to target, and the existing problems of currently marketed products from the viewpoint of the patient and the physician. Drugs of Tomorrow 2002: Pain - In depth analysis of the current pain pipeline Fibromyalgia WebPage: (http://www.paintracking.com/) FEDERAL REGULATION OF CONTROLLED SUBSTANCES FOR PAIN MANAGEMENT IN PHARMACY AND PHARMACEUTICAL CARE, A pharmacist CE program of The University of Florida College of Pharmacy and DRUG TOPICS: http://www.drugtopics.com/be_core/content/journals/d/data/2003/0407/show_article.jsp?filename=dce04a2003.html&title=CE%3A+Pain+management++regulation&navtype= PainEDU.org, an online resource for clinically relevant information about pain assessment and management. PainEDU.org offers medical professionals the opportunity to stay current with news and literature in the pain management field, to meet some of the leading pain practitioners and to earn continuing education credits: http://www.painedu.org The National Foundation for the Treatment of Pain: http://www.paincare.org/ Opioids work in post-herpetic neuralgia (Press release from AAN): http://www.aan.com/press/press/releases/100702_opioids.htm American Academy of Hospice and Palliative Medicine (AAHPM), an organization of physicians and other medical professionals dedicated to excellence in palliative medicine, the prevention and relief of suffering among patients and families: http://www.aahpm.org/ Pain Management Education for Physicians and Other Healthcare Professionals, CME from the AMA: http://www.ama-assn.org/ama/pub/category/10171.html Anesthetic and Life Support Drugs Advisory Committee - Updated Open Public Hearing On Controlled Release Pain Products ON Tuesday & Wednesday, September 9-10, 2003 Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Avenue, Bethesda, MD http://www.fda.gov/oc/advisory/accalendar/cder12529dd09091003.html NCI Pain & Palliative Care Textbook: http://www.nci.nih.gov/cancerinfo/pdq/supportivecare/pain/healthprofessional Pain, Pain Management and the Law: (http://www.painandthelaw.org/intro/index.php) The National Foundation for the Treatment of Pain: (http://www.paincare.org/) PAIN MEDICINE News and other full text medical publications from McMahonMed.com: (http://www.painmedicinenews.com/indexpub.cfm?pubid=26) Legal Side of Pain: (http://www.legalsideofpain.com) Instant access to your state?s pain laws,other materials and related items, from the Legal Side of Pain website:(http://www.legalsideofpain.com/members/handy_handbooks.htm) No-cost CME available for physicians, nurses, pharmacists and psychologists. Complete 6-24 interactive cases and enhance your approach to care. Also see The PainEDU.ORG MANUAL: A CLINICAL COMPANION, 2ND EDITION An up-to-date, free guide to providing top-notch pain management to patients: (www.painedu.org) PRESCRIPTION PAIN MEDICATIONS: Frequently Asked Questions & Answers for Health Care Professionals, and Law Enforcement Personnel Supported by Drug Enforcement Administration Last Acts Partnership Pain & Policy Studies Group, University of Wisconsin: (http://www.deadiversion.usdoj.gov/faq/pain_meds_faqs.pdf) OR (http://www.medsch.wisc.edu/painpolicy/domestic/DEA_faq.htm) OR (http://www.stoppain.org/faq.pdf) From the Journal of Pain and Symptom Management (JPSM), Vol. 28 No. 2 August 2004 A Reassessment of Trends in the Medical Use and Abuse of Opioid Analgesics and Implications for Diversion Control: 1997-2002 Aaron M. Gilson, Ph.D.; Karen M. Ryan, MA; David E. Joranson, MSSW; June L. Dahl, Ph.D.: (http://www.medsch.wisc.edu/painpolicy/publicat/04jpsm/04jpsm.pdf) (http://www.stoppain.org) Integrative care for pain: (http://www.healingchronicpain.org/) Advocacy for Opioid Agonist Therapy (OAT) Patients Reports from SAMHSA/OAS on Heroin, Opiates & Injection Drug Use: (http://www.samhsa.gov/oas/heroin.htm) Addiction Treatment Watchdog Advocates For the Integration of Recovery and Methadone (AFIRM) Virginia Alliance of Methadone Advocates (VAMA) Advocates for Recovery through Medicine (ARM) http://www.q4q.nl/methwork/ http://www.q4q.nl/methwork/ http://www.q4q.nl/methwork/ New, from Portland, Maine "Over-reaction to overdoses in Portland means tighter rules on a drug universally accepted to treat opiate addictions. It makes us look like a bunch of backwater idiots." Local Copy JAMA article on Methadone Patients and Liver Transplant / WebLinkJAMA issue with articles on OAT patients and HCV treatment / WebLinkAntiquated Attitudes Still Keeping Liver Transplants from Methadone Patients / WebLinkNIH Consensus Conference on Effective Medical Treatment for Opiate Addiction (initiated by Dr. Trachtenberg) / WebLinkCenter for Substance Abuse Treatment (CSAT/SAMHSA/USPHS/DHHS) / WebLinkMedical Maintenance: A Training and Resource Guide for Office-Based Physicians / WebLinkMedical Maintenance: A Training and Resource Guide for Office-Based Physicians / Local CopySchaffer Library of Drug Policy / WebLinkAdvocacy Community's Website / WebLinkBaltimore County Court Decision on OAT/NIMBY / Americans w/Disabilities Act (ADA)Federal Confidentiality Regulations for Addiction Treatment / WebLinkMethylnaltrexone for constipation in patients on chronic opioids / WebLinkMore on Methylnaltrexone for constipation in patients on chronic opioids / WebLinkThesis Research from Netherlands on Methadone Maintenance / WebLinkNIDDK (NIH) Says Methadone no Bar to HCV Treatment / WebLinkChronic Hepatitis C: Current Disease Managment With Methadone / NIH/NIDDKNew Opioid Agonist (Methadone & LAAM) Treatment Regulations / 42 CFR Part 8; Federal Register: January 17, 2001 Methadone in the Treatment of Narcotic Addiction by Dr. Andrew J. Byrne, MB BS, 1995. Methadone in the Treatment of Narcotic Addiction by Dr. Andrew J. Byrne, MB BS, 1995. Effective Medical Treatment of Heroin Addiction in Office-Based Practices with A Focus on Methadone Maintenance-November 6, 2000 at the New York Academy of Medicine, NY. WORKING DRAFT REPORT M E T H A D O N E M A I N T E N A N C E G U I D E L I N E S approved by the College of Physicians and Surgeons of Ontario for members of the College and they replace the August 1996 Methadone Treatment Guidelines and the earlier 1992 publication of Health Canada entitled "The use of opioids in the treatment of opioid dependence". In 1996, following program changes made by the Bureau of Drug Surveillance (Health Canada), the College of Physicians and Surgeons entered into a formal partnership with the Ontario Substance Abuse Bureau of the Ministry of Health through a funding agreement to administer the provincial methadone program. The mandate of the College's program since 1996 has been to improve the quality and accessibility of methadone maintenance treatment in Ontario. This has been accomplished in conjunction with the Centre for Addiction and Mental Health (CAMH) and the Ontario College of Pharmacists (OCP). The profile of methadone treatment in Ontario has been enhanced through the outreach activities and the recruitment of individual physicians to prescribe methadone in the treatment of opioid dependence. The guidelines are intended to reflect the general standard of practice in Ontario for prescribing methadone in the maintenance treatment of opioid dependence. OAT clinics around the country have recently been targetted by the organization CRACK, Children Requiring a Caring Kommunity, continues to expand its base of operations across the country. CRACK is a non-profit organization that uses a cash incentive program to influence drug-addicted women (and now Methadone patients too) with a promise of $200 upon verification that they have been sterilized or use long-term birth control methods and devices, such as Norplant, Depo-Provera, or an IUD. This links to Current policies of the American Public Health Association that oppose coercing women into sterilization or Norplant use, and that affirm the Association?s support for expanded drug treatment facilities for pregnant women who use harmful drugs3 and its recognition that ?racism and its consequences are dangerous to health.? It also highlights the Association?s concern about the controversial use of cash incentives to influence health decision-making including reproductive decisions. (SHORT-TERM METHADONE ADMINISTRATION REDUCES ALCOHOL CONSUMPTION IN NON-ALCOHOLIC HEROIN ADDICTS (F. Caputo, et al) Ohio drives recovering Addiction Patients across state lines Methadone, ciprofloxacin, and adverse drug reactions; by Herrlin K, Segerdahl M, Gustafsson LL, Kalso E.Lancet 2000 Dec 16;356(9247):2069-70. More on Quinolone drug interactions OPIOID DEPENDENCE DURING PREGNANCY (text file): Effects and Management by Karol Kaltenbach, PhD, Vincenzo Berghella, MD, and Loretta Finnegan, MD. OBSTETRICS AND GYNECOLOGY CLINICS OF NORTH AMERICA. VOLUME 25 ? NUMBER I ? MARCH 1998 139 PP. 140-51. OPIOID DEPENDENCE DURING PREGNANCY (pdf Image file): Effects and Management by Karol Kaltenbach, PhD, Vincenzo Berghella, MD, and Loretta Finnegan, MD. OBSTETRICS AND GYNECOLOGY CLINICS OF NORTH AMERICA. VOLUME 25 ? NUMBER I ? MARCH 1998 139 PP. 140-51. Regulatory Exception from DEA to Requirement for OTP Registration for Methadone treatment of Inpatients The Epidemiology of Opiate Addiction in the United States by JOHN C. BALL, Ph.D. CARL D. CHAMBERS, Ph.D. (1970) METHADONE MAINTENANCE TREATMENT Pharmacokinetics, Psychopathology and Craving ©1997 Dr Jan Willem de Vos The Methadone Handbook (for BRITISH PATIENTS),on line edition, by Andrew Preston The Methadone Briefing (for BRITISH PROFESSIONALS): An easy to use reference guide by Andrew Preston, RGN, RMN, Community Nurse, Drug Team, West Dorset Community Alcohol and Drugs Advisory Service, Dorchester. href="http://jama.ama-assn.org/issues/v288n7/abs/joc11894.html"> New in JAMA, August 21, 2002: Methadone Doses Improving; and Accreditation helps. Liver transplantation for patients on methadone maintenance: Liver Transplantation September 2002 Volume 8 Number 9 Medline Search on Methadone Drug Interactions. International Center for the Advancement of Addiction Treatment (Beth Israel - http://www.mmtp.org) Facilities Providing Methadone/LAAM Treatment to Clients with Opiate Addiction (December 6, 2002)- New OAS Report on OAT Clinics: (http://www.samhsa.gov/oas/2k2/methadoneTX/methadoneTX.cfm) (Local Copy) AVIGNON (Dec 12-16): Workshop on Optimal Care for Opioid Addiction: Role of General Practitioners (NEW-Jan 6): (http://www.opiateaddictionrx.info/whatsnew.asp?id=355) HEROIN: Challenge for the 21st Century by Susan M. Gordon, Ph.D. (http://www.caron.org/pdf/Heroin.pdf) A Caron Foundation report (Local Copy) Report on methadone clinic backfires on Oshawa council: Business, crime rate unaffected, survey finds Clinic dispenses to addiction patients, but PricewaterhouseCoopers' $60,000 report concludes no new problems caused by clinic. (03/03/03 - from the Toronto Star March 3, 2003 ) Home page of EUROMETHWORK, (European Methadone Network), a forum for those who are active in the "substitution" treatment field in the European Region: http://www.q4q.nl/methwork/ Home page of EUROMETHWORK, (European Methadone Network), a forum for those who are active in the "substitution" treatment field in the European Region: http://www.q4q.nl/methwork/home2.htm (Under Construction) Methadone Mortality Final Report / Trachtenberg et al (SAMHSA) Setting the Record Straight on Methadone (HTML) / Stuart Leavitt, PhD Setting the Record Straight on Methadone (PDF) / Stuart Leavitt, PhD Set the Record Straight on Methadone 3/16/2004 by Stuart Leavitt, PhD. to the Portland (ME) Press Herald (http://www.pressherald.com/viewpoints/cvoice/040316methadone.shtml) / WebLink Federal Confidentiality Regulations (42CFR2) 42 CFR Part 2.31 Consent Form for Suboxone Rx Federal Confidentiality Regulations for Substance Abuse Patient Records 42 CFR, Part 2) Bookmark to SAMHSA CSAT Technical Assistance Publication (TAP) 13 on Federal Confidentiality Regulations for Substance Abuse Patient Records 42 CFR, Part 2) CSAT Technical Assistance Publication (TAP) 18 on Federal Confidentiality Regulations for Substance Abuse Patient Records 42 CFR, Part 2) (Checklist for Compliance Federal Confidentiality Regulations for Substance Abuse Patient Records 42 CFR, Part 2) Bookmark to SAMHSA Release of Information form under 42CFR2, for use when writing a buprenorphine prescription for addiction treatment(Under the Drug Addiction Treatment Act of 2000). Use of this form will allow the prescribing physician to confirm his/her prescription's validity to the pharmacist without violationg Federal confidentiality regulations (42CFR2). UNC Chapel Hill School of Social Work Web-based Interactive course on Federal Confidentiality Regulations for Substance Abuse Patient Records 42 CFR, Part 2) BOOKMARK TO COA ACCREDITATION STANDARDS DEALING WITH CONFIDENTIALITY ___________________________________________________________________________ CHAPTER I -- PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A -- GENERAL PROVISIONS PART 2 -- CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS SUBPART A -- INTRODUCTION 42 CFR 2.1 § 2.1 Statutory authority for confidentiality of drug abuse patient records. The restrictions of these regulations upon the disclosure and use of drug abuse patient records were initially authorized by section 408 of the Drug Abuse Prevention, Treatment, and Rehabilitation Act (21 U.S.C. 1175). That section as amended was transferred by Pub. L. 98-24 to section 527 of the Public Health Service Act which is codified at 42 U.S.C. 290ee-3. The amended statutory authority is set forth below: § 290ee-3. Confidentiality of patient records. (a) Disclosure authorization Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section. (b) Purposes and circumstances of disclosure affecting consenting patient and patient regardless of consent (1) The content of any record referred to in subsection (a) of this section may be disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed under regulations prescribed pursuant to subsection (g) of this section. (2) Whether or not the patient, with respect to whom any given record referred to in subsection (a) of this section is maintained, gives his written consent, the content of such record may be disclosed as follows: (A) To medical personnel to the extent necessary to meet a bona fide medical emergency. (B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient identities in any manner. (C) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefor. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient, to the physician-patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosure. (c) Prohibition against use of record in making criminal charges or investigation of patient Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record referred to in subsection (a) of this section may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient. (d) Continuing prohibition against disclosure irrespective of status as patient The prohibitions of this section continue to apply to records concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient. (e) Armed Forces and Veterans' Administration; interchange of records; report of suspected child abuse and neglect to State or local authorities The prohibitions of this section do not apply to any interchange of records -- (1) within the Armed Forces or witrhin those components of the Veterans' Administration furnishing health care to veterans, or (2) between such components and the Armed Forces. The prohibitions of this section do not apply to the reporting under State law of incidents of suspected child abuse and neglect to the appropriate State or local authorities. (f) Penalty for first and subsequent offenses Any person who violates any provision of this section or any regulation issued pursuant to this section shall be fined not more than $ 500 in the case of a first offense, and not nore than $ 5,000 in the case of each subsequent offense. (g) Regulations; interagency consultations; definitions, safeguards, and procedures, including procedures and criteria for issuance and scope of orders Except as provided in subsection (h) of this section, the Secretary, after consultation with the Administrator of Veterans' Affairs and the heads of other Federal departments and agencies substantially affected thereby, shall prescribe regulations to carry out the purposes of this section. These regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection (b)(2)(C) of this section, as in the judgment of the Secretary are necessary or proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith. (Subsection (h) was superseded by section 111(c)(3) of Pub. L. 94-581. The responsibility of the Administrator of Veterans' Affairs to write regulations to provide for confidentiality of drug abuse patient records under Title 38 was moved from 21 U.S.C. 1175 to 38 U.S.C. 4134.) HISTORY: 52 FR 21809, June 9, 1987. AUTHORITY: AUTHORITY NOTE APPLICABLE TO ENTIRE PART: Sec. 408 of Pub. L. 92-255, 86 Stat. 79, as amended by sec. 303 (a), (b) of Pub L. 93-282, 83 Stat. 137, 138; sec. 4(c)(5)(A) of Pub. L. 94-237, 90 Stat. 244; sec. 111(c)(3) of Pub. L. 94-581, 90 Stat. 2852; sec. 509 of Pub. L. 96-88, 93 Stat. 695; sec. 973(d) of Pub. L. 97-35, 95 Stat. 598; and transferred to sec. 527 of the Public Health Service Act by sec. 2(b)(16)(B) of Pub. L. 98-24, 97 Stat. 182 and as amended by sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290ee-3) and sec. 333 of Pub. L. 91-616, 84 Stat. 1853, as amended by sec. 122(a) of Pub. L. 93-282, 88 Stat. 131; and sec. 111(c)(4) of Pub. L. 94-581, 90 Stat. 2852 and transferred to sec. 523 of the Public Health Service Act by sec. 2(b)(13) of Pub. L. 98-24, 97 Stat. 181 and as amended by sec. 106 of Pub. L. 99-401, 100 Stat. 907 (42 U.S.C. 290dd-3), as amended by sec. 131 of Pub. L. 102-321, 106 Stat. 368, (42 U.S.C. 290dd-2). 886 words Title 42, part 2, Confidentiality of alcohol and drug abuse patient records 42 CFR 2.2 § 2.2 Statutory authority for confidentiality of alcohol abuse patient records. The restrictions of these regulations upon the disclosure and use of alcohol abuse patient records were initially authorized by section 333 of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (42 U.S.C. 4582). The section as amended was transferred by Pub. L. 98-24 to section 523 of the Public Health Service Act which is codified at 42 U.S.C. 290dd-3. The amended statutory authority is set forth below: § 290dd-3. Confidentiality of patient records (a) Disclosure authorization Records of the identity, diagnosis, prognosis, or treatment of any patient which are maintained in connection with the performance of any program or activity relating to alcoholism or alcohol abuse education, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States shall, except as provided in subsection (e) of this section, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized under subsection (b) of this section. (b) Purposes and circumstances of disclosure affecting consenting patient and patient regardless of consent (1) The content of any record referred to in subsection (a) of this section may be disclosed in accordance with the prior written consent of the patient with respect to whom such record is maintained, but only to such extent, under such circumstances, and for such purposes as may be allowed under regulations prescribed pursuant to subsection (g) of this section. (2) Whether or not the patient, with respect to whom any given record referred to in subsection (a) of this section is maintained, gives his written consent, the content of such record may be disclosed as follows: (A) To medical personnel to the extent necessary to meet a bona fide medical emergency. (B) To qualified personnel for the purpose of conducting scientific research, management audits, financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit, or evaluation, or otherwise disclose patient identities in any manner. (C) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good cause therefore. In assessing good cause the court shall weigh the public interest and the need for disclosure against the injury to the patient, to the physician-patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosure. (c) Prohibition against use of record in making criminal charges or investigation of patient Except as authorized by a court order granted under subsection (b)(2)(C) of this section, no record referred to in subsection (a) of this section may be used to initiate or substantiate any criminal charges against a patient or to conduct any investigation of a patient. (d) Continuing prohibition against disclosure irrespective of status as patient The prohibitions of this section continue to apply to records concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient. (e) Armed Forces and Veterans' Administration; interchange of record of suspected child abuse and neglect to State or local authorities The prohibitions of this section do not apply to any interchange of records (1) within the Armed Forces or within those components of the Veterans' Administration furnishing health care to veterans, or (2) between such components and the Armed Forces. The prohibitions of this section do not apply to the reporting under State law of incidents of suspected child abuse and neglect to the appropriate State or local authorities. (f) Penalty for first and subsequent offenses Any person who violates any provision of this section or any regulation issued pursuant to this section shall be fined not more than $ 500 in the case of a first offense, and not more than $ 5,000 in the case of each subsequent offense. (g) Regulations of Secretary; definitions, safeguards, and procedures, including procedures and criteria for issuance and scope of orders Except as provided in subsection (h) of this section, the Secretary shall prescribe regulations to carry out the purposes of this section. These regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders under subsection(b)(2)(C) of this section, as in the judgment of the Secretary are necessary or proper to effectuate the purposes of this section, to prevent circumvention or evasion thereof, or to facilitate compliance therewith. 42 CFR 2.3 § 2.3 Purpose and effect. (a) Purpose. Under the statutory provisions quoted in §§ 2.1 and 2.2, these regulations impose restrictions upon the disclosure and use of alcohol and drug abuse patient records which are maintained in connection with the performance of any federally assisted alcohol and drug abuse program. The regulations specify: (1) Definitions, applicability, and general restrictions in subpart B (definitions applicable to § 2.34 only appear in that section); (2) Disclosures which may be made with written patient consent and the form of the written consent in subpart C; (3) Disclosures which may be made without written patient consent or an authorizing court order in subpart D; and (4) Disclosures and uses of patient records which may be made with an authorizing court order and the procedures and criteria for the entry and scope of those orders in subpart E. (b) Effect. (1) These regulations prohibit the disclosure and use of patient records unless certain circumstances exist. If any circumstances exists under which disclosure is permitted, that circumstance acts to remove the prohibition on disclosure but it does not compel disclosure. Thus, the regulations do not require disclosure under any circumstances. (2) These regulations are not intended to direct the manner in which substantive functions such as research, treatment, and evaluation are carried out. They are intended to insure that an alcohol or drug abuse patient in a federally assisted alcohol or drug abuse program is not made more vulnerable by reason of the availability of his or her patient record than an individual who has an alcohol or drug problem and who does not seek treatment. (3) Because there is a criminal penalty (a fine--see 42 U.S.C. 290ee-3(f), 42 U.S.C. 290dd-3(f) and 42 CFR 2.4) for violating the regulations, they are to be construed strictly in favor of the potential violator in the same manner as a criminal statute (see M. Kraus & Brothers v. United States, 327 U.S. 614, 621-22, 66 S. Ct. 705, 707-08 (1946)). 42 CFR 2.4 § 2.4 Criminal penalty for violation. Under 42 U.S.C. 290ee-3(f) and 42 U.S.C. 290dd-3(f), any person who violates any provision of those statutes or these regulations shall be fined not more than $ 500 in the case of a first offense, and not more than $ 5,000 in the case of each subsequent offense. 42 CFR 2.5 § 2.5 Reports of violations. (a) The report of any violation of these regulations may be directed to the United States Attorney for the judicial district in which the violation occurs. (b) The report of any violation of these regulations by a methadone program may be directed to the Regional Offices of the Food and Drug Administration. 42 CFR 2.11 § 2.11 Definitions. For purposes of these regulations: Alcohol abuse means the use of an alcoholic beverage which impairs the physical, mental, emotional, or social well-being of the user. Drug abuse means the use of a psychoactive substance for other than medicinal purposes which impairs the physical, mental, emotional, or social well-being of the user. Diagnosis means any reference to an individual's alcohol or drug abuse or to a condition which is identified as having been caused by that abuse which is made for the purpose of treatment or referral for treatment. Disclose or disclosure means a communication of patient indentifying information, the affirmative verification of another person's communication of patient identifying information, or the communication of any information from the record of a patient who has been identified. Informant means an individual: (a) Who is a patient or employee of a program or who becomes a patient or employee of a program at the request of a law enforcement agency or official: and (b) Who at the request of a law enforcement agency or official observes one or more patients or employees of the program for the purpose of reporting the information obtained to the law enforcement agency or official. Patient means any individual who has applied for or been given diagnosis or treatment for alcohol or drug abuse at a federally assisted program and includes any individual who, after arrest on a criminal charge, is identified as an alcohol or drug abuser in order to determine that individual's eligibility to participate in a program. Patient identifying information means the name, address, social security number, fingerprints, photograph, or similar information by which the identity of a patient can be determined with reasonable accuracy and speed either directly or by reference to other publicly available information. The term does not include a number assigned to a patient by a program, if that number does not consist of, or contain numbers (such as a social security, or driver's license number) which could be used to identify a patient with reasonable accuracy and speed from sources external to the program. Person means an individual, partnership, corporation, Federal, State or local government agency, or any other legal entity. Program means: (a) An individual or entity (other than a general medical care facility) who holds itself out as providing, and provides, alcohol or drug abuse diagnosis, treatment or referral for treatment; or (b) An identified unit within a general medical facility which holds itself out as providing, and provides, alcohol or drug abuse diagnosis, treatment or referral for treatment; or (c) Medical personnel or other staff in a general medical care facility whose primary function is the provision of alcohol or drug abuse diagnosis, treatment or referral for treatment and who are identified as such providers. (See § 2.12(e)(1) for examples.) Program director means: (a) In the case of a program which is an individual, that individual: (b) In the case of a program which is an organization, the individual designated as director, managing director, or otherwise vested with authority to act as chief executive of the organization. Qualified service organization means a person which: (a) Provides services to a program, such as data processing, bill collecting, dosage preparation, laboratory analyses, or legal, medical, accounting, or other professional services, or services to prevent or treat child abuse or neglect, including training on nutrition and child care and individual and group therapy, and (b) Has entered into a written agreement with a program under which that person: (1) Acknowledges that in receiving, storing, processing or otherwise dealing with any patient records from the progams, it is fully bound by these regulations; and (2) If necessary, will resist in judicial proceedings any efforts to obtain access to patient records except as permitted by these regulations. Records means any information, whether recorded or not, relating to a patient received or acquired by a federally assisted alcohol or drug program. Third party payer means a person who pays, or agrees to pay, for diagnosis or treatment furnished to a patient on the basis of a contractual relationship with the patient or a member of his family or on the basis of the patient's eligibility for Federal, State, or local governmental benefits. Treatment means the management and care of a patient suffering from alcohol or drug abuse, a condition which is identified as having been caused by that abuse, or both, in order to reduce or eliminate the adverse effects upon the patient. Undercover agent means an officer of any Federal, State, or local law enforcement agency who enrolls in or becomes an employee of a program for the purpose of investigating a suspected violation of law or who pursues that purpose after enrolling or becoming employed for other purposes. 42 CFR 2.12 § 2.12 Applicability. (a) General -- (1) Restrictions on disclosure. The restrictions on disclosure in these regulations apply to any information, whether or not recorded, which: (i) Would identify a patient as an alcohol or drug abuser either directly, by reference to other publicly available information, or through verification of such an identification by another person; and (ii) Is drug abuse information obtained by a federally assisted drug abuse program after March 20, 1972, or is alcohol abuse information obtained by a federally assisted alcohol abuse program after May 13, 1974 (or if obtained before the pertinent date, is maintained by a federally assisted alcohol or drug abuse program after that date as part of an ongoing treatment episode which extends past that date) for the purpose of treating alcohol or drug abuse, making a diagnosis for that treatment, or making a referral for that treatment. (2) Restriction on use. The restriction on use of information to initiate or substantiate any criminal charges against a patient or to conduct any criminal investigation of a patient (42 U.S.C. 290ee-3(c), 42 U.S.C. 290dd-3(c)) applies to any information, whether or not recorded which is drug abuse information obtained by a federally assisted drug abuse program after March 20, 1972, or is alcohol abuse information obtained by a federally assisted alcohol abuse program after May 13, 1974 (or if obtained before the pertinent date, is maintained by a federally assisted alcohol or drug abuse program after that date as part of an ongoing treatment episode which extends past that date), for the purpose of treating alcohol or drug abuse, making a diagnosis for the treatment, or making a referral for the treatment. (b) Federal assistance. An alcohol abuse or drug abuse program is considered to be federally assisted if: (1) It is conducted in whole or in part, whether directly or by contract or otherwise by any department or agency of the United States (but see paragraphs (c)(1) and (c)(2) of this section relating to the Veterans' Administration and the Armed Forces); (2) It is being carried out under a license, certification, registration, or other authorization granted by any department or agency of the United States including but not limited to: (i) Certification of provider status under the Medicare program; (ii) Authorization to conduct methadone maintenance treatment (see 21 CFR 291.505); or (iii) Registration to dispense a substance under the Controlled Substances Act to the extent the controlled substance is used in the treatment of alcohol or drug abuse; (3) It is supported by funds provided by any department or agency of the United States by being: (i) A recipient of Federal financial assistance in any form, including financial assistance which does not directly pay for the alcohol or drug abuse diagnosis, treatment, or referral activities; or (ii) Conducted by a State or local government unit which, through general or special revenue sharing or other forms of assistance, receives Federal funds which could be (but are not necessarily) spent for the alcohol or drug abuse program; or (4) It is assisted by the Internal Revenue Service of the Department of the Treasury through the allowance of income tax deductions for contributions to the program or through the granting of tax exempt status to the program. (c) Exceptions -- (1) Veterans' Administration. These regulations do not apply to information on alcohol and drug abuse patients maintained in connection with the Veterans' Administraton provisions of hospital care, nursing home care, domiciliary care, and medical services under title 38, United States Code. Those records are governed by 38 U.S.C. 4132 and regulations issued under that authority by the Administrator of Veterans' Affairs. (2) Armed Forces. These regulations apply to any information described in paragraph (a) of this section which was obtained by any component of the Armed Forces during a period when the patient was subject to the Uniform Code of Military Justice except: (i) Any interchange of that information within the Armed Forces; and (ii) Any interchange of that information between the Armed Forces and those components of the Veterans Administration furnishing health care to veterans. (3) Communication within a program or between a program and an entity having direct administrative control over that program. The restrictions on disclosure in these regulations do not apply to communications of information between or among personnel having a need for the information in connection with their duties that arise out of the provision of diagnosis, treatment, or referral for treatment of alcohol or drug abuse if the communications are (i) Within a program or (ii) Between a program and an entity that has direct administrative control over the program. (4) Qualified Service Organizations. The restrictions on disclosure in these regulations do not apply to communications between a program and a qualified service organization of information needed by the organization to provide services to the program. (5) Crimes on program premises or against program personnel. The restrictions on disclosure and use in these regulations do not apply to communications from program personnel to law enforcement officers which -- (i) Are directly related to a patient's commission of a crime on the premises of the program or against program personnel or to a threat to commit such a crime; and (ii) Are limited to the circumstances of the incident, including the patient status of the individual committing or threatening to commit the crime, that individual's name and address, and that individual's last known whereabouts. (6) Reports of suspected child abuse and neglect. The restrictions on disclosure and use in these regulations do not apply to the reporting under State law of incidents of suspected child abuse and neglect to the appropriate State or local authorities. However, the restrictions continue to apply to the original alcohol or drug abuse patient records maintained by the program including their disclosure and use for civil or criminal proceedings which may arise out of the report of suspected child abuse and neglect. (d) Applicability to recipients of information -- (1) Restriction on use of information. The restriction on the use of any information subject to these regulations to initiate or substantiate any criminal charges against a patient or to conduct any criminal investigation of a patient applies to any person who obtains that information from a federally assisted alcohol or drug abuse program, regardless of the status of the person obtaining the information or of whether the information was obtained in accordance with these regulations. This restriction on use bars, among other things, the introduction of that information as evidence in a criminal proceeding and any other use of the information to investigate or prosecute a patient with respect to a suspected crime. Information obtained by undercover agents or informants (see § 2.17) or through patient access (see § 2.23) is subject to the restriction on use. (2) Restrictions on disclosures -- Third party payers, administrative entities, and others. The restrictions on disclosure in these regulations apply to: (i) Third party payers with regard to records disclosed to them by federally assisted alcohol or drug abuse programs; (ii) Entities having direct administrative control over programs with regard to information communicated to them by the program under § 2.12(c)(3); and (iii) Persons who receive patient records directly from a federally assisted alcohol or drug abuse program and who are notified of the restrictions on redisclosure of the records in accordance with § 2.32 of these regulations. (e) Explanation of applicability -- (1) Coverage. These regulations cover any information (including information on referral and intake) about alcohol and drug abuse patients obtained by a program (as the terms "patient" and "program" are defined in § 2.11) if the program is federally assisted in any manner described in § 2.12(b). Coverage includes, but is not limited to, those treatment or rehabilitation programs, employee assistance programs, programs within general hospitals, school-based programs, and private practitioners who hold themselves out as providing, and provide alcohol or drug abuse diagnosis, treatment, or referral for treatment. However, these regulations would not apply, for example, to emergency room personnel who refer a patient to the intensive care unit for an apparent overdose, unless the primary function of such personnel is the provision of alcohol or drug abuse diagnosis, treatment or referral and they are identified as providing such services or the emergency room has promoted itself to the community as a provider of such services. (2) Federal assistance to program required. If a patient's alcohol or drug abuse diagnosis, treatment, or referral for treatment is not provided by a program which is federally conducted, regulated or supported in a manner which constitutes Federal assistance under § 2.12(b), that patient's record is not covered by these regulations. Thus, it is possible for an individual patient to benefit from Federal support and not be covered by the confidentiality regulations because the program in which the patient is enrolled is not federally assisted as defined in § 2.12(b). For example, if a Federal court placed an individual in a private for-profit program and made a payment to the program on behalf of that individual, that patient's record would not be covered by these regulations unless the program itself received Federal assistance as defined by § 2.12(b). (3) Information to which restrictions are applicable. Whether a restriction is on use or disclosure affects the type of information which may be available. The restrictions on disclosure apply to any information which would identify a patient as an alcohol or drug abuser. The restriction on use of information to bring criminal charges against a patient for a crime applies to any information obtained by the program for the purpose of diagnosis, treatment, or referral for treatment of alcohol or drug abuse. (Note that restrictions on use and disclosure apply to recipients of information under § 2.12(d).) (4) How type of diagnosis affects coverage. These regulations cover any record of a diagnosis identifying a patient as an alcohol or drug abuser which is prepared in connection with the treatment or referral for treatment of alcohol or drug abuse. A diagnosis prepared for the purpose of treatment or referral for treatment but which is not so used is covered by these regulations. The following are not covered by these regulations: (i) Diagnosis which is made solely for the purpose of providing evidence for use by law enforcement authorities; or (ii) A diagnosis of drug overdose or alcohol intoxication which clearly shows that the individual involved is not an alcohol or drug abuser (e.g., involuntary ingestion of alcohol or drugs or reaction to a prescribed dosage of one or more drugs). 42 CFR 2.13 § 2.13 Confidentiality restrictions. (a) General. The patient records to which these regulations apply may be disclosed or used only as permitted by these regulations and may not otherwise be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any Federal, State, or local authority. Any disclosure made under these regulations must be limited to that information which is necessary to carry out the purpose of the disclosure. (b) Unconditional compliance required. The restrictions on disclosure and use in these regulations apply whether the holder of the information believes that the person seeking the information already has it, has other means of obtaining it, is a law enforcement or other official, has obtained a subpoena, or asserts any other justification for a disclosure or use which is not permitted by these regulations. (c) Acknowledging the presence of patients: Responding to requests. (1) The presence of an identified patient in a facility or component of a facility which is publicly identified as a place where only alcohol or drug abuse diagnosis, treatment, or referral is provided may be acknowledged only if the patient's written consent is obtained in accordance with subpart C of these regulations or if an authorizing court order is entered in accordance with subpart E of these regulations. The regulations permit acknowledgement of the presence of an identified patient in a facility or part of a facility if the facility is not publicy identified as only an alcohol or drug abuse diagnosis, treatment or referral facility, and if the acknowledgement does not reveal that the patient is an alcohol or drug abuser. (2) Any answer to a request for a disclosure of patient records which is not permissible under these regulations must be made in a way that will not affirmatively reveal that an identified individual has been, or is being diagnosed or treated for alcohol or drug abuse. An inquiring party may be given a copy of these regulations and advised that they restrict the disclosure of alcohol or drug abuse patient records, but may not be told affirmatively that the regulations restrict the disclosure of the records of an identified patient. The regulations do not restrict a disclosure that an identified individual is not and never has been a patient. 42 CFR 2.14 § 2.14 Minor patients. (a) Definition of minor. As used in these regulations the term "minor" means a person who has not attained the age of majority specified in the applicable State law, or if no age of majority is specified in the applicable State law, the age of eighteen years. (b) State law not requiring parental consent to treatment. If a minor patient acting alone has the legal capacity under the applicable State law to apply for and obtain alcohol or drug abuse treatment, any written consent for disclosure authorized under subpart C of these regulations may be given only by the minor patient. This restriction includes, but is not limited to, any disclosure of patient identifyi |
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