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Medical Review Officer Manual
Department of Health and Human Services Substance Abuse and Mental Health Services Administration Center for Substance Abuse Prevention Medical Review Officer Manual for Federal Agency Workplace Drug Testing Programs EFFECTIVE OCTOBER 1, 2010 Note: This manual applies to Federal agency drug testing programs that come under Executive Order 12564 dated September 15, 1986, section 503 of Public Law 100-71, 5 U.S.C. section 7301 note dated July 11, 1987, and the Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (73 FR 71858) dated November 25, 2008 (effective October 1, 2010). This manual does not apply to specimens submitted for testing under U.S. Department of Transportation (DOT) Procedures for Transportation Workplace Drug and Alcohol Testing Programs (49 CFR Part 40). The current version of this manual and other information including MRO Case Studies are available on the Drug Testing page under Medical Review Officer (MRO) Resources on the SAMHSA website: http://www.workplace.samhsa.gov Previous Versions of this Manual are Obsolete 3 Table of Contents Chapter 1. The Medical Review Officer (MRO)........................................................................... 6 Chapter 2. The Federal Drug Testing Custody and Control Form ................................................ 7 Chapter 3. Urine Drug Testing ...................................................................................................... 9 A. Federal Workplace Drug Testing Overview.................................................................. -
Dexmethylphenidate Hydrochloride Extended-Release Capsules These
DEXMETHYLPHENIDATE HYDROCHLORIDE- dexmethylphenidate hydrochloride capsule, extended release Granules Pharmaceuticals Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION Dexmethylphenidate hydrochloride extended-release capsules These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. • CNS stimulants, including dexmethylphenidate hydrochloride extended-release, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence( 5.1, 9.2, 9.3). • Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy ( 5.1, 9.2). INDICATIONS AND USAGE Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1) DOSAGE AND ADMINISTRATION • Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2) • Patients currently on methylphenidate: Dexmethylphenidate hydrochloride extended-release dosage is half the current total daily dosage of methylphenidate -
Marijuana Venture
WWW.MARIJUANAVENTURE.COM VOLUME 2 / ISSUE 6 M A R I J U A N A THEVENTURE JOURNAL OF PROFESSIONAL CANNABIS GROWERS AND RETAILERS THE NEW LOOK OF MARIJUANA CHANGING INDUSTRY STEREOTYPES GREENHOUSE TECHNOLOGY What you need to know before buying your grow facility SAVING THE LIFEBLOOD Water is becoming a precious commodity for cannabis growers JUNE 2015 $6.99 THE CASH-ONLY INDUSTRY Companies rush to fill banking void A MESSAGE FROM THE PUBLISHER When it comes to weed, what’s in a name or look? Medicinal products obviously shouldn’t be named ‘crack’ re we crazy to Aput a couple of THE LEGAL good-looking business people with a red Fer- MARIJUANA rari on the front cover BUSINESS IS READY of a marijuana maga- zine? Maybe ... if we TO LOOK AND ACT PUBLISHER buy into the traditional view that our audience should be — or is LIKE IT’S A REAL GREG JAMES — made up of counterculture folks who de- [email protected] cry yuppie toys and symbols of self-indul- BUSINESS. EDITOR gent excess. On the other hand, maybe we GARRETT RUDOLPH do, you’ll find enough contradictory infor- at Marijuana Venture just think it’s time to [email protected] go full-bore into accepting the simple fact mation to make you more confused than a that most people entering the legal, recre- homeless person on house arrest! For ex- SALES MANAGER ational marijuana business are really doing ample, OG Kush is said to treat headaches, LISA SMITH it because they want to make money, and but then just below the ailments it treats, [email protected] don’t have a problem admitting it. -
Selegiline) in Monkeys*
Intravenous self-administration studies with /-deprenyl (selegiline) in monkeys* /-Deprenyl and its stereoisomer d-deprenyl did not maintain intravenous self-administration behavior in rhesus monkeys. In contrast, /-methamphetamine, the major metabolite of /-deprenyl, as well as the baseline drug, cocaine, maintained high rates of intravenous self-administration behavior. Treatment with /-deprenyl doses up to 1.0 mg/kg before self-administration sessions failed to alter self-administra- tion of either cocaine or /-methamphetamine. Thus /-deprenyl did not appear to have cocaine- or meth- amphetamine-like reinforcing properties in monkeys and was ineffective in altering established patterns of psychomotor-stimulant self-administration behavior. These results support clinical findings that de- spite long-term use of /-deprenyl for the treatment of Parkinson's disease by large numbers of patients, no instances of abuse have been documented. /-Deprenyl has recently been suggested as a potential med- ication for the treatment of various types of drug abuse, including cocaine abuse, but its failure to pro- duce selective effects in decreasing cocaine or methamphetamine self-administration behavior in the present experiments makes such an application seem unlikely. (CLIN PHARMACOL THER 1994;56:774-80.) Gail D. Winger, PhD,a Sevil Yasar, MD,b'd'e S. Steven Negus, PhD,a and Steven R. Goldberg, pIli/i d'e Ann Arbor, Mich., and Baltimore, Md. From the 'Department of Pharmacology, University of Michigan /-Deprenyl (selegiline) has been known for several -
Recommended Methods for the Identification and Analysis Of
Vienna International Centre, P.O. Box 500, 1400 Vienna, Austria Tel: (+43-1) 26060-0, Fax: (+43-1) 26060-5866, www.unodc.org RECOMMENDED METHODS FOR THE IDENTIFICATION AND ANALYSIS OF AMPHETAMINE, METHAMPHETAMINE AND THEIR RING-SUBSTITUTED ANALOGUES IN SEIZED MATERIALS (revised and updated) MANUAL FOR USE BY NATIONAL DRUG TESTING LABORATORIES Laboratory and Scientific Section United Nations Office on Drugs and Crime Vienna RECOMMENDED METHODS FOR THE IDENTIFICATION AND ANALYSIS OF AMPHETAMINE, METHAMPHETAMINE AND THEIR RING-SUBSTITUTED ANALOGUES IN SEIZED MATERIALS (revised and updated) MANUAL FOR USE BY NATIONAL DRUG TESTING LABORATORIES UNITED NATIONS New York, 2006 Note Mention of company names and commercial products does not imply the endorse- ment of the United Nations. This publication has not been formally edited. ST/NAR/34 UNITED NATIONS PUBLICATION Sales No. E.06.XI.1 ISBN 92-1-148208-9 Acknowledgements UNODC’s Laboratory and Scientific Section wishes to express its thanks to the experts who participated in the Consultative Meeting on “The Review of Methods for the Identification and Analysis of Amphetamine-type Stimulants (ATS) and Their Ring-substituted Analogues in Seized Material” for their contribution to the contents of this manual. Ms. Rosa Alis Rodríguez, Laboratorio de Drogas y Sanidad de Baleares, Palma de Mallorca, Spain Dr. Hans Bergkvist, SKL—National Laboratory of Forensic Science, Linköping, Sweden Ms. Warank Boonchuay, Division of Narcotics Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand Dr. Rainer Dahlenburg, Bundeskriminalamt/KT34, Wiesbaden, Germany Mr. Adrian V. Kemmenoe, The Forensic Science Service, Birmingham Laboratory, Birmingham, United Kingdom Dr. Tohru Kishi, National Research Institute of Police Science, Chiba, Japan Dr. -
Serotonin Syndrome How to Avoid, Identify, &
Serotonin syndrome How to avoid, identify, & As the list of serotonergic agents grows, recognizing hyperthermic states and potentially dangerous drug combinations is critical to our patients’ safety. 14 Current VOL. 2, NO. 5 / MAY 2003 p SYCHIATRY Current p SYCHIATRY treat dangerous drug interactions Harvey Sternbach, MD Clinical professor of psychiatry UCLA Neuropsychiatric Institute Los Angeles, CA romptly identifying serotonin syn- drome and acting decisively can keep side effects at the mild end of the spec- Ptrum. Symptoms of this potentially dangerous syndrome range from minimal in patients starting selective serotonin reuptake inhibitors (SSRIs) to fatal in those combining monoamine oxidase inhibitors (MAOIs) with serotonergic agents. This article presents the latest evidence on how to: • reduce the risk of serotonin syndrome • recognize its symptoms • and treat patients with mild to life- threatening symptoms. WHAT IS SEROTONIN SYNDROME? Serotonin syndrome is characterized by changes in autonomic, neuromotor, and cognitive-behav- ioral function (Table 1) triggered by increased serotonergic stimulation. It typically results from pharmacodynamic and/or pharmacokinetic in- teractions between drugs that increase serotonin activity.1,2 continued VOL. 2, NO. 5 / MAY 2003 15 Serotonin Table 1 activity or reduced ability to How to recognize serotonin syndrome secrete endothelium-derived nitric oxide may diminish the System Clinical signs and symptoms ability to metabolize serotonin.2 Autonomic Diaphoresis, hyperthermia, hypertension, tachycardia, pupillary dilatation, nausea, POTENTIALLY DANGEROUS diarrhea, shivering COMBINATIONS Neuromotor Hyperreflexia, myoclonus, restlessness, MAOIs. Serotonin syndrome tremor, incoordination, rigidity, clonus, has been reported as a result of teeth chattering, trismus, seizures interactions between MAOIs— Cognitive-behavioral Confusion, agitation, anxiety, hypomania, including selegiline and insomnia, hallucinations, headache reversible MAO-A inhibitors (RIMAs)—and various sero- tonergic compounds. -
Evidence That Formulations of the Selective MAO-B Inhibitor, Selegiline, Which Bypass First-Pass Metabolism, Also Inhibit MAO-A in the Human Brain
BNL-107759-2015-JA Evidence that formulations of the selective MAO-B inhibitor, selegiline, which bypass first-pass metabolism, also inhibit MAO-A in the human brain Joanna S. Fowler1, Jean Logan2, Nora D. Volkow3,4, Elena Shumay4, Fred McCall-Perez5, Michelle Gilmor7, Millard Jayne4, Gene-Jack Wang4, David L. Alexoff1, Karen Apelskog-Torres4, Barbara Hubbard1, Pauline Carter1, Payton King1, Stanley Fahn6, Frank Telang4, Colleen Shea1, Youwen Xu1, Lisa Muench4 1Biosciences Department, Brookhaven National Laboratory, Upton, NY 11973, USA 2New York University Langone Medical Center, New York, NY 10016, USA 3National Institute on Drug Abuse, Bethesda, MD, USA 4National Institute on Alcohol Abuse and Alcoholism, Bethesda MD, USA 5Targeted Medical Pharma Inc, Los Angeles, CA 90077, USA 6Novartis Pharmaceuticals, East Hanover, NJ 07936, USA 7Neurological Institute, Columbia University, New York, NY, USA Submitted to Neuropsychopharmacology July 2014 Biological, Environmental and Climate Sciences Department Brookhaven National Laboratory U.S. Department of Energy Office of Science Office of Biological and Environmental Research Notice: This manuscript has been authored by employees of Brookhaven Science Associates, LLC under Contract No. DE-AC02-98CH10886 with the U.S. Department of Energy. The publisher by accepting the manuscript for publication acknowledges that the United States Government retains a non-exclusive, paid-up, irrevocable, world-wide license to publish or reproduce the published form of this manuscript, or allow others to do -
Anticonvulsants Antipsychotics Benzodiazepines/Anxiolytics ADHD
Anticonvulsants Antidepressants Generic Name Brand Name Generic Name Brand Name Carbamazepine Tegretol SSRI Divalproex Depakote Citalopram Celexa Lamotrigine Lamictal Escitalopram Lexapro Topirimate Topamax Fluoxetine Prozac Fluvoxamine Luvox Paroxetine Paxil Antipsychotics Sertraline Zoloft Generic Name Brand Name SNRI Typical Desvenlafaxine Pristiq Chlorpromazine Thorazine Duloextine Cymbalta Fluphenazine Prolixin Milnacipran Savella Haloperidol Haldol Venlafaxine Effexor Perphenazine Trilafon SARI Atypical Nefazodone Serzone Aripiprazole Abilify Trazodone Desyrel Clozapine Clozaril TCA Lurasidone Latuda Clomimpramine Enafranil Olanzapine Zyprexa Despiramine Norpramin Quetiapine Seroquel Nortriptyline Pamelor Risperidone Risperal MAOI Ziprasidone Geodon Phenylzine Nardil Selegiline Emsam Tranylcypromine Parnate Benzodiazepines/Anxiolytics DNRI Generic Name Brand Name Bupropion Wellbutrin Alprazolam Xanax Clonazepam Klonopin Sedative‐Hypnotics Lorazepam Ativan Generic Name Brand Name Diazepam Valium Clonidine Kapvay Buspirone Buspar Eszopiclone Lunesta Pentobarbital Nembutal Phenobarbital Luminal ADHD Medicines Zaleplon Sonata Generic Name Brand Name Zolpidem Ambien Stimulant Amphetamine Adderall Others Dexmethylphenidate Focalin Generic Name Brand Name Dextroamphetamine Dexedrine Antihistamine Methylphenidate Ritalin Non‐stimulant Diphenhydramine Bendryl Atomoxetine Strattera Anti‐tremor Guanfacine Intuniv Benztropine Cogentin Mood stabilizer (bipolar treatment) Lithium Lithane Never Mix, Never Worry: What Clinicians Need to Know about -
Gonzales V. Raich Enfeebles the Rehnquist Court's Lopez-Morrison Framework
University of Miami Law Review Volume 61 Number 1 Volume 61 Number 1 (October 2006) Article 7 10-1-2006 Guns, Drugs, and. Federalism? - Gonzales V. Raich Enfeebles the Rehnquist Court's Lopez-Morrison Framework David L. Luck Follow this and additional works at: https://repository.law.miami.edu/umlr Part of the Law Commons Recommended Citation David L. Luck, Guns, Drugs, and. Federalism? - Gonzales V. Raich Enfeebles the Rehnquist Court's Lopez-Morrison Framework, 61 U. Miami L. Rev. 237 (2006) Available at: https://repository.law.miami.edu/umlr/vol61/iss1/7 This Note is brought to you for free and open access by the Journals at University of Miami School of Law Institutional Repository. It has been accepted for inclusion in University of Miami Law Review by an authorized editor of University of Miami School of Law Institutional Repository. For more information, please contact [email protected]. Guns, Drugs, and ... Federalism? - Gonzales v. Raich Enfeebles the Rehnquist Court's Lopez-Morrison Framework DAVID L. LUCK* I. INTRODUCTION ...................................................... 238 A. A Brief History of Commerce Clause Jurisprudence ................... 238 B. Organization & Objectives ........................................ 243 9. 1. DOES RAICH MAKE SENSE 243 II. RAICH'S LEGAL ISSUES ............................................... 244 A. The Controlled Substances Act & Medical Marijuana.................. 244 B. California's Compassionate Use Act ................................ 248 C . Preemption ..................................................... 250 D. The Supreme Court's Third Era Commerce Clause Jurisprudence & Lopez and Morrison's Collective Impact ................................... 251 1. MAPPING THE COURT'S THIRD ERA JURISPRUDENCE .................. .... 251 2. LOPEZ, MORRISON, & THE RISE OF THE FOURTH ERA .................... 258 III. GONZALES V. RAICH.. ................................................. 260 A. Facts & Procedure .............................................. 260 B. -
ZELAPAR™ (Selegiline Hydrochloride) Orally Disintegrating Tablets
ZELAPAR™ (selegiline hydrochloride) orally disintegrating tablets DESCRIPTION ZELAPARTM Orally Disintegrating Tablets contain selegiline hydrochloride, a levorotatory acetylenic derivative of phenthylamine. Selegiline hydrochloride is described chemically as: (-)-(R)-N, α-dimethyl-N-2-propynylphenethylamine hydrochloride and its structural formula is: Its empirical formula is C13H17N·HCl, representing a molecular weight of 223.75. Selegiline hydrochloride is a white to almost white crystalline powder that is freely soluble in water, chloroform, and methanol. ZELAPARTM Orally Disintegrating Tablets are available for oral administration (not to be swallowed) in a strength of 1.25 mg. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, citric acid, yellow iron oxide, and grapefruit flavor. CLINICAL PHARMACOLOGY The mechanisms accounting for selegiline’s beneficial adjunctive action in the treatment of Parkinson’s disease are not fully understood. Inhibition of monoamine oxidase type B (MAO-B) activity is generally considered to be of primary importance; in addition, there is evidence that selegiline may act through other mechanisms to increase dopaminergic activity. Selegiline is best known as an irreversible inhibitor of monoamine oxidase (MAO), an intracellular enzyme associated with the outer membrane of mitochondria. Selegiline inhibits MAO by acting as a suicide substrate for the enzyme; that is, it is converted by MAO to an active moiety which combines irreversibly with the active site and/or the enzyme’s essential flavin adenine dinucleotide (FAD) cofactor. Because selegiline has greater affinity for type B rather than for type A active sites, it can serve as a selective inhibitor of MAO type B if it is administered at the recommended dose. -
Review: Synthetic Methods for Amphetamine
Review: Synthetic Methods for Amphetamine A. Allen1 and R. Ely2 1Array BioPharma Inc., Boulder, Colorado 80503 2Drug Enforcement Administration, San Francisco, CA Abstract: This review focuses on synthesis of amphetamine. The chemistry of these methods will be discussed, referenced and precursors highlighted. This review covers the period 1985 to 2009 with emphasis on stereoselective synthesis, classical non-chiral synthesis and bio-enzymatic reactions. The review is directed to the Forensic Community and thus highlights precursors, reagents, stereochemistry, type and name reactions. The article attempts to present, as best as possible, a list of references covering amphetamine synthesis from 1900 -2009. Although this is the same fundamental ground as the recent publication by K. Norman; “Clandestine Laboratory Investigating Chemist Association” 19, 3(2009)2-39, this current review offers another perspective. Keywords: Review, Stereoselective, Amphetamine, Syntheses, references, Introduction: It has been 20 years since our last review of the synthetic literature for the manufacture of amphetamine and methamphetamine. Much has changed in the world of organic transformation in this time period. Chiral (stereoselective) synthetic reactions have moved to the forefront of organic transformations and these stereoselective reactions, as well as regio-reactions and biotransformations will be the focus of this review. Within the synthesis of amphetamine, these stereoselective transformations have taken the form of organometallic reactions, enzymatic reactions, ring openings, - aminooxylations, alkylations and amination reactions. The earlier review (J. Forensic Sci. Int. 42(1989)183-189) addressed for the most part, the ―reductive‖ synthetic methods leading to this drug of abuse. It could be said that the earlier review dealt with ―classical organic transformations,‖ roughly covering the period from 1900-1985. -
Lisa L. Pittman of Counsel
Lisa L. Pittman Of Counsel Coats Rose, P.C. Terrace 2 2700 Via Fortuna, Suite 350 Austin, Texas 78746 Phone: 512.541.3601 Fax: 512.469.9408 [email protected] Lisa is Co-chair of the Cannabis Business Law practice. A leader and authority in the cannabis industry, which includes state legal marijuana and federally legal hemp, Lisa was recently appointed to be a Nonresident Fellow at Rice University’s Baker Institute for Public Policy as a member of the Drug Policy Program. Lisa also was appointed to the Texas Department of Agriculture Industrial Hemp Advisory Council, a role that provides her insight and influence on the regulations for the Texas hemp program, with the goal of propelling Texas to be the preeminent producer of hemp in the United States. Lisa is also a prolific publisher of peer reviewed publications, is frequently asked to speak to professional organizations nationwide, and is often interviewed by the press. A native Texan, Lisa’s work in the legalization movement in Texas has led her to be referred to as “The First Lady of Texas Cannabis Law.” Throughout Lisa’s 20-year career, she has litigated and tried disputes relating to labor & employment, breach of contract, commercial banking, fraud, fiduciary duty, construction defect and injury, deceptive trade practices, premises liability, professional liability, and products liability. Lisa also possesses extensive expertise in complex commercial insurance coverage matters, having both defended insurance companies and advocated for policy holders in commercial property, residential property, and life insurance matters. After 15 years of practice, Lisa almost left the law to open a wellness center for women to consult about plant-based therapies and nutrition, as part of a life-long passion for children’s health that began with her volunteer work as a teenager at Texas Children’s Hospital.