Safety Notice 009/20 Acetylfentanyl and Fentanyl In
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Medications to Treat Opioid Use Disorder Research Report
Research Report Revised Junio 2018 Medications to Treat Opioid Use Disorder Research Report Table of Contents Medications to Treat Opioid Use Disorder Research Report Overview How do medications to treat opioid use disorder work? How effective are medications to treat opioid use disorder? What are misconceptions about maintenance treatment? What is the treatment need versus the diversion risk for opioid use disorder treatment? What is the impact of medication for opioid use disorder treatment on HIV/HCV outcomes? How is opioid use disorder treated in the criminal justice system? Is medication to treat opioid use disorder available in the military? What treatment is available for pregnant mothers and their babies? How much does opioid treatment cost? Is naloxone accessible? References Page 1 Medications to Treat Opioid Use Disorder Research Report Discusses effective medications used to treat opioid use disorders: methadone, buprenorphine, and naltrexone. Overview An estimated 1.4 million people in the United States had a substance use disorder related to prescription opioids in 2019.1 However, only a fraction of people with prescription opioid use disorders receive tailored treatment (22 percent in 2019).1 Overdose deaths involving prescription opioids more than quadrupled from 1999 through 2016 followed by significant declines reported in both 2018 and 2019.2,3 Besides overdose, consequences of the opioid crisis include a rising incidence of infants born dependent on opioids because their mothers used these substances during pregnancy4,5 and increased spread of infectious diseases, including HIV and hepatitis C (HCV), as was seen in 2015 in southern Indiana.6 Effective prevention and treatment strategies exist for opioid misuse and use disorder but are highly underutilized across the United States. -
2015-02 Toxicology Rapid Testing Panel
SOUTH CAROLINA LAW ENFORCEMENT DIVISION NIKKI R. HALEY MARK A. KEEL Governor Chief FORENSIC SERVICES LABORATORY CUSTOMER NOTICE 2015-02 REGARDING TOXICOLOGY RAPID TESTING PANEL August 12, 2015 This notice is to inform the Coroners of South Carolina of a new testing panel available through the SLED Toxicology Department. On Monday, August 17th, the Toxicology Department will begin offering both a Rapid Testing Panel in addition to the already available Expanded Testing Panel. This Rapid Testing Panel is to be utilized in cases where the Expanded Testing Panel is not warranted, specifically where a cause of death has already been established. The Rapid Testing Panel will consist of volatiles analysis, to include, ethanol, acetone, isopropanol and methanol, drug screens, and drug confirmation/quantitation of positive screens. The cases assigned to the Rapid Testing Panel will have an expedited turnaround time. Targeted turn around times will be two weeks for negative cases and six weeks or less for positive cases. While every effort will be made to adhere to these time frames, additional time may be required on occasion due to the nature of postmortem samples. Submitters will be notified if there is a problem with a particular sample. Please see attachment regarding specifically which substances are covered by the Rapid Testing Panel and the Expanded Testing Panel. As always, a detailed case history and list of drugs suspected is appreciated. Rapid Panel and Expanded Panel will be choices available in iLAB. Please contact Lt. Dustin Smith (803-896-7385) with additional questions. ALI-359-T An Accredited Law Enforcement Agency P.O. -
Food and Drug Administration 5630 Fishers Lane, Rm
Sent via Electronic and U.S. Mail October 13, 2015 James R. Hunter Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2015-N-0045 for International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ketamine; Phenazepam; Etizolam; 1-cyclohexyl-4-(1,2-diphenylethyl)-piperazine (MT-45); N-(1-Phenethylpiperidin- 4-yl)-N-phenylacetamide (Acetylfentanyl); α-Pyrrolidinovalerophenone (α-PVP); 4- Fluoroamphetamine (4-FA); para-Methyl-4-methylaminorex (4,4’-DMAR); para- Methoxymethylamphetamine (PMMA); 2-(ethylamino)-2-(3-methoxyphenyl)- cyclohexanone (Methoxetamine or MXE); Request for Comments Dear Mr. Hunter: This letter responds to the Food and Drug Administration’s (FDA) request for comments that appeared in the Federal Register on October 5, 2015, concerning International Drug Scheduling. The Association of Public and Land-grant Universities (APLU) represents 237 public research universities, land-grant institutions, state university systems, and affiliated organizations. Many of our member institutions have veterinary and medical schools and nearly all our institutions have researchers and students who conduct biomedical research. On behalf of our institutional membership, APLU appreciates this opportunity to provide the FDA with comments. APLU strongly objects to any attempt to alter the international regulation of ketamine that would result in increased difficulty for biomedical researchers to use this drug for legitimate and appropriate treatments. The United States currently classifies ketamine as a Schedule III drug under the Controlled Substance Act (CSA). As such, strict regulations and safeguards are already in place to prevent its illegal use. As known to FDA, Schedule I drugs are defined as those with no currently acceptable medical use, a lack of accepted safety for use under medical supervision, and a high potential for abuse. -
Recommended Methods for the Identification and Analysis of Fentanyl and Its Analogues in Biological Specimens
Recommended methods for the Identification and Analysis of Fentanyl and its Analogues in Biological Specimens MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES Laboratory and Scientific Section UNITED NATIONS OFFICE ON DRUGS AND CRIME Vienna Recommended Methods for the Identification and Analysis of Fentanyl and its Analogues in Biological Specimens MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES UNITED NATIONS Vienna, 2017 Note Operating and experimental conditions are reproduced from the original reference materials, including unpublished methods, validated and used in selected national laboratories as per the list of references. A number of alternative conditions and substitution of named commercial products may provide comparable results in many cases. However, any modification has to be validated before it is integrated into laboratory routines. ST/NAR/53 Original language: English © United Nations, November 2017. All rights reserved. The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries. Mention of names of firms and commercial products does not imply the endorse- ment of the United Nations. This publication has not been formally edited. Publishing production: English, Publishing and Library Section, United Nations Office at Vienna. Acknowledgements The Laboratory and Scientific Section of the UNODC (LSS, headed by Dr. Justice Tettey) wishes to express its appreciation and thanks to Dr. Barry Logan, Center for Forensic Science Research and Education, at the Fredric Rieders Family Founda- tion and NMS Labs, United States; Amanda L.A. -
Brain Injury and Opioid Overdose
Brain Injury and Opioid Overdose: Acquired Brain Injury is damage to the brain 2.8 million brain injury related occurring after birth and is not related to congenital or degenerative disease. This includes anoxia and hospital stays/deaths in 2013 hypoxia, impairment (lack of oxygen), a condition consistent with drug overdose. 70-80% of hospitalized patients are discharged with an opioid Rx Opioid Use Disorder, as defined in DSM 5, is a problematic pattern of opioid use leading to clinically significant impairment, manifested by meaningful risk 63,000+ drug overdose-related factors occurring within a 12-month period. deaths in 2016 Overdose is injury to the body (poisoning) that happens when a drug is taken in excessive amounts “As the number of drug overdoses continues to rise, and can be fatal. Opioid overdose induces respiratory doctors are struggling to cope with the increasing number depression that can lead to anoxic or hypoxic brain of patients facing irreversible brain damage and other long injury. term health issues.” Substance Use and Misuse is: The frontal lobe is • Often a contributing factor to brain injury. History of highly susceptible abuse/misuse is common among individuals who to brain oxygen have sustained a brain injury. loss, and damage • Likely to increase for individuals who have misused leads to potential substances prior to and post-injury. loss of executive Acute or chronic pain is a common result after brain function. injury due to: • Headaches, back or neck pain and other musculo- Sources: Stojanovic et al 2016; Melton, C. Nov. 15,2017; Devi E. skeletal conditions commonly reported by veterans Nampiaparampil, M.D., 2008; Seal K.H., Bertenthal D., Barnes D.E., et al 2017; with a history of brain injury. -
SAMHSA Opioid Overdose Prevention TOOLKIT
SAMHSA Opioid Overdose Prevention TOOLKIT Opioid Use Disorder Facts Five Essential Steps for First Responders Information for Prescribers Safety Advice for Patients & Family Members Recovering From Opioid Overdose TABLE OF CONTENTS SAMHSA Opioid Overdose Prevention Toolkit Opioid Use Disorder Facts.................................................................................................................. 1 Scope of the Problem....................................................................................................................... 1 Strategies to Prevent Overdose Deaths.......................................................................................... 2 Resources for Communities............................................................................................................. 4 Five Essential Steps for First Responders ........................................................................................ 5 Step 1: Evaluate for Signs of Opioid Overdose ................................................................................ 5 Step 2: Call 911 for Help .................................................................................................................. 5 Step 3: Administer Naloxone ............................................................................................................ 6 Step 4: Support the Person’s Breathing ........................................................................................... 7 Step 5: Monitor the Person’s Response .......................................................................................... -
Examining Opioid and Heroin-Related Drug Overdose In
health Center for Health and Environmental Data watch November 2016 No. 100 Office of eHealth and Data • Health Surveys & Evaluation Branch Examining Opioid and Heroin-Related Drug • Public Health Overdose in Colorado Informatics Branch Allison Rosenthal, MPH • Registries and Vital SAMHSA/CSTE Applied Epidemiology Fellow, Violence and Injury Prevention Statistics Branch - Mental Health Promotion Branch; Kirk Bol, MSPH Registries and Vital Statistics Branch; Barbara Gabella, MSPH Violence and Injury Prevention - Mental Health Promotion Branch. Background Nationally and in Colorado, opioid use disorders have emerged as a significant public health concern. Starting in the 1990s, opioid prescriptions (or, pain medications such as oxycodone, hydrocodone, and their combination with acetaminophen) began to rise nationwide partially due to the promotion of extended-release tablets and a change in prescriber culture to recognize the needs of patients with chronic pain (Okie, 2010). The dramatic increase in use has been associated with dependency, addiction, and other adverse health events including, but not limited to: heroin use disorders, spread of hepatitis infections and HIV, and fatal drug overdose (Bonhert et al, 2011; Garland et al, 2014; Paulozzi et al, 2006; Peters et al, 2016; Suryaprasad et al, 2014; and Young & Havens, 2011). The National Survey on Drug Use and Health estimates that from 2013-2014, 4.9 percent of the Colorado population of ages 12 years and older used prescription pain relievers non-medically (95% CI: 4.0-6.1%), which is similar to the national rate (4.1%, 95% CI: 3.9-4.2%). The Colorado Department of Public Health and Environment (CDPHE) is monitoring the severity of the epidemic using a variety of available data, including mortality data from death certificates registered in Colorado. -
ESTIMATED WORLD REQUIREMENTS of NARCOTIC DRUGS in GRAMS for 2021 (July Update)
ESTIMATED WORLD REQUIREMENTS OF NARCOTIC DRUGS IN GRAMS FOR 2021 (July update) Afghanistan Bezitramide 1 Codeine 20 000 Cannabis 7 050 Dextropropoxyphene 20 000 Cannabis resin 1 Diphenoxylate 800 Coca leaf 1 Fentanyl 6 Cocaine 15 Methadone 120 000 Codeine 700 000 Morphine 10 000 Codeine-N-oxide 1 Pethidine 2 000 Dextromoramide 1 Pholcodine 5 000 Dextropropoxyphene 170 000 Albania Difenoxin 1 Cocaine 1 Dihydrocodeine 1 Codeine 1 190 000 Diphenoxylate 1 Fentanyl 300 Dipipanone 1 Heroin 1 Ecgonine 2 Methadone 16 500 Ethylmorphine 1 Morphine 7 500 Etorphine 1 Oxycodone 1 500 Fentanyl 17 200 Pethidine 2 500 Heroin 1 Pholcodine 1 600 Hydrocodone 11 000 Remifentanil 10 Hydromorphone 4 000 Sufentanil 2 Ketobemidone 1 Algeria Levorphanol 1 Alfentanil 400 Methadone 110 000 Cannabis 3 Morphine 1 590 000 Cocaine 5 Morphine-N-oxide 1 Codeine 2 500 000 Nicomorphine 1 Etorphine 1 Norcodeine 1 Fentanyl 900 Normethadone 1 Heroin 2 Normorphine 1 Methadone 4 000 Opium 10 Morphine 15 000 Oripavine 1 Oxycodone 4 000 Oxycodone 60 000 Pethidine 3 000 Oxymorphone 1 Pholcodine 1 500 000 Pethidine 50 000 Remifentanil 1 Phenoperidine 1 Sufentanil 50 Pholcodine 1 Andorra Piritramide 1 Cannabis 2 000 Remifentanil 17 000 Fentanyl 100 Sufentanil 10 Methadone 1 000 Thebacon 1 Morphine 500 Thebaine 77 000 Oxycodone 2 000 Tilidine 1 Pethidine 500 Armenia Remifentanil 4 Codeine 3 000 Angola Fentanyl 50 Alfentanil 24 Methadone 22 000 Codeine 21 600 Morphine 8 000 Dextromoramide 188 Thebaine 4 100 Dextropropoxyphene 200 Trimeperidine 1 500 Dihydrocodeine 500 Aruba* Diphenoxylate -
Risk of Death Associated with Kratom Use Compared to Opioids T ⁎ Jack E
Preventive Medicine 128 (2019) 105851 Contents lists available at ScienceDirect Preventive Medicine journal homepage: www.elsevier.com/locate/ypmed Risk of death associated with kratom use compared to opioids T ⁎ Jack E. Henningfielda,b, , Oliver Grundmannc, Jane K. Babind, Reginald V. Fanta, Daniel W. Wanga, Edward J. Conea,b a PInneyAssociates, Bethesda, MD, United States of America b The Johns Hopkins University School of Medicine, United States of America c College of Pharmacy, Department of Medicinal Chemistry, University of Florida, Gainesville, FL, United States of America d The Law Office of Jane K. Babin, PC, San Diego, CA, J.D. University of San Diego School of Law, J.D. Law, Purdue University, United States of America ARTICLE INFO ABSTRACT Keywords: Kratom use appears to be increasing across the United States, increasing attention to deaths in which kratom use Kratom was detected. Most such deaths have been ascribed to fentanyl, heroin, benzodiazepines, prescription opioids, Mitragynine cocaine and other causes (e.g., homicide, suicide and various preexisting diseases). Because kratom has certain Opioids opioid-like effects (e.g., pain relief), and is used by some people as a substitute for opioids for pain or addiction, Mortality risk kratom has been compared to “narcotic-like opioids” (e.g., morphine) with respect to risk of death despite Opioid epidemic evidence that its primary alkaloid, mitragynine, carries little of the signature respiratory depressing effects of morphine-like opioids. This commentary summarizes animal toxicology data, surveys and mortality data asso- ciated with opioids and kratom to provide a basis for estimating relative mortality risk. Population-level mor- tality estimates attributed to opioids as compared to kratom, and the per user mortality risks of opioids as compared to kratom are provided. -
NIDA Drug Supply Program Catalog, 25Th Edition
RESEARCH RESOURCES DRUG SUPPLY PROGRAM CATALOG 25TH EDITION MAY 2016 CHEMISTRY AND PHARMACEUTICS BRANCH DIVISION OF THERAPEUTICS AND MEDICAL CONSEQUENCES NATIONAL INSTITUTE ON DRUG ABUSE NATIONAL INSTITUTES OF HEALTH DEPARTMENT OF HEALTH AND HUMAN SERVICES 6001 EXECUTIVE BOULEVARD ROCKVILLE, MARYLAND 20852 160524 On the cover: CPK rendering of nalfurafine. TABLE OF CONTENTS A. Introduction ................................................................................................1 B. NIDA Drug Supply Program (DSP) Ordering Guidelines ..........................3 C. Drug Request Checklist .............................................................................8 D. Sample DEA Order Form 222 ....................................................................9 E. Supply & Analysis of Standard Solutions of Δ9-THC ..............................10 F. Alternate Sources for Peptides ...............................................................11 G. Instructions for Analytical Services .........................................................12 H. X-Ray Diffraction Analysis of Compounds .............................................13 I. Nicotine Research Cigarettes Drug Supply Program .............................16 J. Ordering Guidelines for Nicotine Research Cigarettes (NRCs)..............18 K. Ordering Guidelines for Marijuana and Marijuana Cigarettes ................21 L. Important Addresses, Telephone & Fax Numbers ..................................24 M. Available Drugs, Compounds, and Dosage Forms ..............................25 -
Kratom Science Brief Columbus Ohio Public Hearing by Jack E
Kratom Science Brief Columbus Ohio Public Hearing By Jack E. Henningfield, PhD Vice President, Research, Health Policy and Abuse Liability PinneyAssociates, Bethesda, Maryland Professor, Adjunct, Department of Psychiatry and Behavioral Sciences The Johns Hopkins University School of Medicine January 28, 2020 I would like to provide some background on the current state of kratom science, its place in public health, and the opioid epidemic in particular. I’d also like to review how our current knowledge can help determine the most appropriate way to regulate kratom in order to minimize risks to kratom consumers, while contributing to their health and wellbeing, as well as to the public health. During the 1980s and 1990s I headed the Clinical Pharmacology laboratory of the National Institute on Drug Abuse (NIDA) and led research across a wide range of substances including opioids, cannabis, cocaine and other stimulants, and a myriad of other drugs. I also worked NIDA, FDA and DEA on drug scheduling issues. I have published nearly 450 papers on these topics and contribute to numerous federal and international reports. I consult on pharmaceutical development and have contributed to the research and/or approval of for most treatments approved for drug, alcohol and nicotine addiction since the 1980s and have advised NIDA, CDC, FDA, the World Health Organization, and other organizations since then. I advise the American Kratom Association on kratom science. That began as a pro bono effort when DEA proposed placing kratom in Schedule I in 2016. My efforts were focused on setting the record straight because my colleagues and I at PinneyAssociates (a team with extensive opioid and other drug experience) believed that DEA and FDA were wrong on the science and policy, and worse, that banning kratom would result in the quick establishment of a deadly kratom black market. -
SOP414 Acetyl Fentanyl by LC MS MS
SOP 414 – Acetylfentanyl Extraction using Protein Precipitation for Quantification by Liquid Chromatography/Electrospray Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) Table of Contents 1. Principle of Assay ........................................................................................................ 3 2. Specimens .................................................................................................................... 4 3. Reagents and Materials ................................................................................................ 4 4. Standards, Controls, and Solutions .............................................................................. 4 5. Equipment and Special Supplies ................................................................................. 5 6. Instrumentation and Parameters .................................................................................. 5 7. Target Ions ................................................................................................................... 6 8. Procedure ..................................................................................................................... 6 9. Calculations ................................................................................................................. 7 10. Quality Control ........................................................................................................ 9 11. Validation of Method ............................................................................................