220-D100 Toxicology Procedures Manual
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Benzodiazepines: Uses and Risks Charlie Reznikoff, MD Hennepin Healthcare
Benzodiazepines: Uses and Risks Charlie Reznikoff, MD Hennepin healthcare 4/22/2020 Overview benzodiazepines • Examples of benzos and benzo like drugs • Indications for benzos • Pharmacology of benzos • Side effects and contraindications • Benzo withdrawal • Benzo tapers 12/06/2018 Sedative/Hypnotics • Benzodiazepines • Alcohol • Z-drugs (Benzo-like sleeping aids) • Barbiturates • GHB • Propofol • Some inhalants • Gabapentin? Pregabalin? 12/06/2018 Examples of benzodiazepines • Midazolam (Versed) • Triazolam (Halcion) • Alprazolam (Xanax) • Lorazepam (Ativan) • Temazepam (Restoril) • Oxazepam (Serax) • Clonazepam (Klonopin) • Diazepam (Valium) • Chlordiazepoxide (Librium) 4/22/2020 Sedatives: gaba stimulating drugs have incomplete “cross tolerance” 12/06/2018 Effects from sedative (Benzo) use • Euphoria/bliss • Suppresses seizures • Amnesia • Muscle relaxation • Clumsiness, visio-spatial impairment • Sleep inducing • Respiratory suppression • Anxiolysis/disinhibition 12/06/2018 Tolerance to benzo effects? • Effects quickly diminish with repeated use (weeks) • Euphoria/bliss • Suppresses seizures • Effects incompletely diminish with repeated use • Amnesia • Muscle relaxation • Clumsiness, visio-spatial impairment • Seep inducing • Durable effects with repeated use • Respiratory suppression • Anxiolysis/disinhibition 12/06/2018 If you understand this pharmacology you can figure out the rest... • Potency • 1 mg diazepam <<< 1 mg alprazolam • Duration of action • Half life differences • Onset of action • Euphoria, clinical utility in acute -
The Toxicology Panel -17Th Nysam (Virtual) Conference 2021
THE TOXICOLOGY PANEL -17TH NYSAM (VIRTUAL) CONFERENCE 2021 MODERATOR: TIMOTHY J. WIEGAND, MD, FACMT, FAACT, DFASAM JoAn Laes, MD Addiction Medicine Faculty Hennepin County Medical Center, Minneapolis, MN Lewis Nelson, MD, FACMT Chair, Department of Emergency Medicine, Rutgers New Jersey Medical School Jeanmarie Perrone, MD Director of Division of Medical Toxicology & Penn Center PANELISTS for Addiction Medicine and Policy Ross Sullivan, MD Director SUNY Upstate Emergency Bridge Clinic & Medical Director Helio Health, Syracuse, NY Paul Wax, MD, FACMT Executive Director the American College of Medical Toxicology CONFLICT OF NONE OF OUR SPEAKERS HAVE ANY CONFLICTS OF INTEREST INTEREST TO DISCLOSE A 27 year-old M with history of opioid and sedative use disorder had been doing well in an outpatient treatment program with mix of counseling and treatment with buprenorphine/naloxone. CASE 1 He entered the program about 9 months prior after a 28 day combined detoxification/inpatient facility stay where he was transitioned from heroin/fentanyl (“10 bags/day”) to the buprenorphine and “detoxified” from 2-4 mg alprazolam and/or 2-4 mg clonazepam daily. CASE 1 About 9 months into the program he is found sleeping at work by his boss and when awoke he is slurring his speech and has trouble walking. This was a job he’d lost prior to treatment but they had let him back in 3 months after starting in treatment after he demonstrated sobriety –he worked with his father in a recycling plant coordinating large shipments and sometimes picking up materials using heavy equipment and other machinery. He lives with his parents and they are quite upset about the incident but he states, “I wasn’t using I was just tired!” CASE 1 The parents communicate with his counselor and he is brought in for a urine drug test –which initially tests positive for benzodiazepines but the confirmation is negative. -
WHO Expert Committee on Drug Dependence
WHO Technical Report Series 1034 This report presents the recommendations of the forty-third Expert Committee on Drug Dependence (ECDD). The ECDD is responsible for the assessment of psychoactive substances for possible scheduling under the International Drug Control Conventions. The ECDD reviews the therapeutic usefulness, the liability for abuse and dependence, and the public health and social harm of each substance. The ECDD advises the Director-General of WHO to reschedule or to amend the scheduling status of a substance. The Director-General will, as appropriate, communicate the recommendations to the Secretary-General of the United Nations, who will in turn communicate the advice to the Commission on Narcotic Drugs. This report summarizes the findings of the forty-third meeting at which the Committee reviewed 11 psychoactive substances: – 5-Methoxy-N,N-diallyltryptamine (5-MeO-DALT) WHO Expert Committee – 3-Fluorophenmetrazine (3-FPM) – 3-Methoxyphencyclidine (3-MeO-PCP) on Drug Dependence – Diphenidine – 2-Methoxydiphenidine (2-MeO-DIPHENIDINE) Forty-third report – Isotonitazene – MDMB-4en-PINACA – CUMYL-PEGACLONE – Flubromazolam – Clonazolam – Diclazepam The report also contains the critical review documents that informed recommendations made by the ECDD regarding international control of those substances. The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO’s constitutional functions is to provide objective, reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications. The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. -
Oral Fluid Drug Test Package Insert
Marijuana (THC) 11-nor-Δ9-THC-9 COOH 4 MTD: Methadone is a synthetic analgesic drug originally used for the Oral Fluid Drug Test treatment of narcotic addiction. In addition to use as a narcotic agonist, methadone is being used more frequently as a pain management agent. The Marijuana (THC) Δ9-THC 50 Package Insert psychological effects induced by using methadone are analgesia, sedation, and respiratory depression. Based on the saliva/plasma ratio calculated over Package insert for testing of the following drugs: > 0.02 % Alcohol (ALC) Alcohol salivary pH ranges of 6.4-7.6 for therapeutic or recreational doses of Amphetamine,Cocaine,Marijuana,Methamphetamine,Opiate,Methadone, B.A.C methadone, a cut-off <50 ng/mL is suggested. Due to this recommendation, Phencyclidine,Oxycodone,Benzodiazepine,Buprenorphine,Barbiturates, the cut-off level of the methadone test was calibrated to 30 ng/mL. Cotinine,EDDP,MDMA,6-MAM,Propoxyphene ,Fentanyl,ETG and Alcohol Tramadol(TRA) 50 Tramadol PCP: Phencyclidine is a hallucinogen and, can be detected in oral fluid as a INTENDED USE & SUMMARY result of the exchange of the drug between the circulatory system and the oral cavity.5 Fentanyl(FEN) 10 The Oral Fluid Drug And Alcohol Test is intended for screening for the Norfentanyl presence of drugs and alcohol and their metabolites in oral fluid. For professional in vitro diagnostic use only. OXY: Oxycodone is a semi-synthetic opioid with a structural similarity to Ethyl codeine. The drug is manufactured by modifying thebaine, an alkaloid found in 150 The Oral Fluid Pipette Test is a lateral flow chromatographic immunoassay for Glucuronide(ETG) the opium poppy. -
Review Memorandum
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k062165 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Qualitative and semi-quantitative enzyme immunoassay E. Applicant: Ortho-Clinical Diagnostics, Inc. F. Proprietary and Established Names: VITROS Chemistry Products BARB Reagent VITROS Chemistry Products Calibrator 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V G. Regulatory Information: 1. Regulation section: 21 CFR 862.3150, Barbiturates test system 21 CFR 862.3200, Clinical Toxicology Calibrator 21 CFR 862.3180, Clinical Toxicology Control 2. Classification: Class II, (reagent, calibrator) Class I, reserved (control) 3. Product code: DIS, DLJ and DIF 4. Panel: Toxicology (91) 1 H. Intended Use: 1. Intended use(s): See Indications for use. 2. Indication(s) for use: VITROS Chemistry Products BARB Reagent: For in vitro diagnostic use only. VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi- quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The VITROS Chemistry Products BARB assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result with this assay. Gas Chromatograpy/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. -
Partial Agreement in the Social and Public Health Field
COUNCIL OF EUROPE COMMITTEE OF MINISTERS (PARTIAL AGREEMENT IN THE SOCIAL AND PUBLIC HEALTH FIELD) RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies, and superseding Resolution AP (82) 2) AND APPENDIX I Alphabetical list of medicines adopted by the Public Health Committee (Partial Agreement) updated to 1 July 1988 APPENDIX II Pharmaco-therapeutic classification of medicines appearing in the alphabetical list in Appendix I updated to 1 July 1988 RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (superseding Resolution AP (82) 2) (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies) The Representatives on the Committee of Ministers of Belgium, France, the Federal Republic of Germany, Italy, Luxembourg, the Netherlands and the United Kingdom of Great Britain and Northern Ireland, these states being parties to the Partial Agreement in the social and public health field, and the Representatives of Austria, Denmark, Ireland, Spain and Switzerland, states which have participated in the public health activities carried out within the above-mentioned Partial Agreement since 1 October 1974, 2 April 1968, 23 September 1969, 21 April 1988 and 5 May 1964, respectively, Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this -
September 25, 2020 Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
September 25, 2020 Guangzhou Wondfo Biotech Co., Ltd. ℅ Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 Re: K202567 Trade/Device Name: Wondfo T-Dip® Multi-Drug Urine Test Panel Wondfo T-Dip® Multi-Drug Urine Test Panel Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, LCM, QBF, QAW, NFW Dated: September 2, 2020 Received: September 4, 2020 Dear Joe Shia: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. -
Application of High Resolution Mass Spectrometry for the Screening and Confirmation of Novel Psychoactive Substances Joshua Zolton Seither [email protected]
Florida International University FIU Digital Commons FIU Electronic Theses and Dissertations University Graduate School 4-25-2018 Application of High Resolution Mass Spectrometry for the Screening and Confirmation of Novel Psychoactive Substances Joshua Zolton Seither [email protected] DOI: 10.25148/etd.FIDC006565 Follow this and additional works at: https://digitalcommons.fiu.edu/etd Part of the Chemistry Commons Recommended Citation Seither, Joshua Zolton, "Application of High Resolution Mass Spectrometry for the Screening and Confirmation of Novel Psychoactive Substances" (2018). FIU Electronic Theses and Dissertations. 3823. https://digitalcommons.fiu.edu/etd/3823 This work is brought to you for free and open access by the University Graduate School at FIU Digital Commons. It has been accepted for inclusion in FIU Electronic Theses and Dissertations by an authorized administrator of FIU Digital Commons. For more information, please contact [email protected]. FLORIDA INTERNATIONAL UNIVERSITY Miami, Florida APPLICATION OF HIGH RESOLUTION MASS SPECTROMETRY FOR THE SCREENING AND CONFIRMATION OF NOVEL PSYCHOACTIVE SUBSTANCES A dissertation submitted in partial fulfillment of the requirements for the degree of DOCTOR OF PHILOSOPHY in CHEMISTRY by Joshua Zolton Seither 2018 To: Dean Michael R. Heithaus College of Arts, Sciences and Education This dissertation, written by Joshua Zolton Seither, and entitled Application of High- Resolution Mass Spectrometry for the Screening and Confirmation of Novel Psychoactive Substances, having been approved in respect to style and intellectual content, is referred to you for judgment. We have read this dissertation and recommend that it be approved. _______________________________________ Piero Gardinali _______________________________________ Bruce McCord _______________________________________ DeEtta Mills _______________________________________ Stanislaw Wnuk _______________________________________ Anthony DeCaprio, Major Professor Date of Defense: April 25, 2018 The dissertation of Joshua Zolton Seither is approved. -
1 'New/Designer Benzodiazepines'
1 ‘New/Designer Benzodiazepines’: an analysis of the literature and psychonauts’ trip reports 2 Laura Orsolini*1,2,3, John M. Corkery1, Stefania Chiappini1, Amira Guirguis1, Alessandro Vento4,5,6,7, 3 Domenico De Berardis3,8,9, Duccio Papanti1, and Fabrizio Schifano1 4 5 1 Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical 6 Sciences, University of Hertfordshire, Hatfield, AL10 9AB, Herts, UK. 7 2 Neomesia Mental Health, Villa Jolanda Hospital, Jesi, Italy. 8 3 Polyedra, Teramo, Italy. 9 4 NESMOS Department (Neurosciences, Mental Health and Sensory Organs), Sapienza University – Rome, School of 10 Medicine and Psychology; Sant’Andrea Hospital, Rome, Italy 11 5 School of psychology - G. Marconi Telematic University, Rome, Italy 12 6 Addictions Observatory (ODDPSS), Rome, Italy 13 7 Mental Health Department - ASL Roma 2, Rome, Italy 14 8 Department of Neuroscience, Imaging and Clinical Science, Chair of Psychiatry, University of “G. D’Annunzio”, Chieti, 15 Italy. 16 9 NHS, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital “G. Mazzini”, ASL 4 17 Teramo, Italy. 18 19 Corresponding author: 20 Laura Orsolini, Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life 21 and Medical Sciences, University of Hertfordshire, Hatfield, AL10 9AB, Herts, UK; Villa Jolanda Hospital, Neomesia 22 Mental Health, Villa Jolanda, Italy; Polyedra, Teramo, Italy; E-mail address: [email protected]. Tel.: (+39) 392 23 3244643. 24 25 Conflicts of Interest 26 The authors declare that this research was conducted in the absence of any commercial or financial relationships 27 that could be construed as a potential conflict of interest. -
The Emergence of New Psychoactive Substance (NPS) Benzodiazepines
Issue: Ir Med J; Vol 112; No. 7; P970 The Emergence of New Psychoactive Substance (NPS) Benzodiazepines. A Survey of their Prevalence in Opioid Substitution Patients using LC-MS S. Mc Namara, S. Stokes, J. Nolan HSE National Drug Treatment Centre Abstract Benzodiazepines have a wide range of clinical uses being among the most commonly prescribed medicines globally. The EU Early Warning System on new psychoactive substances (NPS) has over recent years detected new illicit benzodiazepines in Europe’s drug market1. Additional reference standards were obtained and a multi-residue LC- MS method was developed to test for 31 benzodiazepines or metabolites in urine including some new benzodiazepines which have been classified as New Psychoactive Substances (NPS) which comprise a range of substances, including synthetic cannabinoids, opioids, cathinones and benzodiazepines not covered by international drug controls. 200 urine samples from patients attending the HSE National Drug Treatment Centre (NDTC) who are monitored on a regular basis for drug and alcohol use and which tested positive for benzodiazepine class drugs by immunoassay screening were subjected to confirmatory analysis to determine what Benzodiazepine drugs were present and to see if etizolam or other new benzodiazepines are being used in the addiction population currently. Benzodiazepine prescription and use is common in the addiction population. Of significance we found evidence of consumption of an illicit new psychoactive benzodiazepine, Etizolam. Introduction Benzodiazepines are useful in the short-term treatment of anxiety and insomnia, and in managing alcohol withdrawal. 1 According to the EMCDDA report on the misuse of benzodiazepines among high-risk opioid users in Europe1, benzodiazepines, especially when injected, can prolong the intensity and duration of opioid effects. -
(12) Patent Application Publication (10) Pub. No.: US 2011/0263526 A1 SATYAM (43) Pub
US 20110263526A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0263526 A1 SATYAM (43) Pub. Date: Oct. 27, 2011 (54) NITRICOXIDE RELEASING PRODRUGS OF CD7C 69/96 (2006.01) THERAPEUTICAGENTS C07C 319/22 (2006.01) CD7C 68/02 (2006.01) (75) Inventor: Apparao SATYAM, Mumbai (IN) A6IP 29/00 (2006.01) A6IP 9/00 (2006.01) (73) Assignee: PIRAMAL LIFE SCIENCES A6IP37/08 (2006.01) LIMITED, Mumbai (IN) A6IP35/00 (2006.01) A6IP 25/24 2006.O1 (21) Appl. No.: 13/092.245 A6IP 25/08 308: A6IP3L/04 2006.O1 (22) Filed: Apr. 22, 2011 A6IP3L/2 308: Related U.S. Application Data 39t. O 308: (60) Provisional application No. 61/327,175, filed on Apr. A6IP3/10 (2006.01) 23, 2010. A6IPL/04 (2006.01) A6IP39/06 (2006.01) Publication Classification A6IP3/02 (2006.01) (51) Int. Cl. A6IP 9/06 (2006.01) A 6LX 3L/7072 (2006.01) 39t. W 308: A6 IK3I/58 (2006.01) A6IP II/08 (2006.015 A6 IK3I/55 (2006.01) A63/62 (2006.015 A6 IK 3/495 (2006.01) A6 IK 3/4439 (2006.01) (52) U.S. Cl. ........... 514/50: 514/166; 514/172: 514/217; A6 IK 3L/455 (2006.01) 514/255.04: 514/338; 514/356; 514/412; A6 IK 3/403 (2006.01) 514/420; 514/423: 514/510,536/28.53:540/67; A6 IK 3/404 (2006.01) 540/591; 544/396; 546/273.7: 546/318: 548/452: A6 IK 3/40 (2006.01) 548/500: 548/537; 549/464; 558/275 A6 IK3I/265 (2006.01) C7H 9/06 (2006.01) (57) ABSTRACT CO7I 71/00 (2006.01) CO7D 22.3/26 (2006.01) The present invention relates to nitric oxide releasing pro C07D 295/14 (2006.01) drugs of known drugs or therapeutic agents which are repre CO7D 40/12 (2006.01) sented herein as compounds of formula (I) wherein the drugs CO7D 213/80 (2006.01) or therapeutic agents contain one or more functional groups C07D 209/52 (2006.01) independently selected from a carboxylic acid, an amino, a CO7D 209/26 (2006.01) hydroxyl and a sulfhydryl group. -
Current Awareness in Clinical Toxicology Editors: Damian Ballam Msc and Allister Vale MD
Current Awareness in Clinical Toxicology Editors: Damian Ballam MSc and Allister Vale MD May 2016 CONTENTS General Toxicology 8 Metals 33 Management 16 Pesticides 35 Drugs 19 Chemical Warfare 37 Chemical Incidents & 28 Plants 37 Pollution Chemicals 29 Animals 38 CURRENT AWARENESS PAPERS OF THE MONTH Efficacy and effectiveness of anti-digoxin antibodies in chronic digoxin poisonings from the DORA study (ATOM-1) Chan BS, Isbister GK, O'Leary M, Chiew A, Buckley NA. Clin Toxicol 2016; online early: doi: 10.1080/15563650.2016.1175620: Context We hypothesized that in chronic digoxin toxicity, anti-digoxin antibodies (Fab) would be efficacious in binding digoxin, but this may not translate into improved clinical outcomes. Objective This study aims to investigate changes in free digoxin concentrations and clinical effects on heart rate and potassium concentrations in chronic digoxin poisoning when anti-digoxin Fab are given. Materials and methods This is a prospective observational study. Patients were recruited if they have been treated with anti-digoxin Fab for chronic digoxin poisoning. Data was entered into a standardised prospective form, supplemented with medical records. Their serum or plasma was collected, analysed for free and bound digoxin and free anti-digoxin Fab concentrations. Results From September 2013 to February 2015, 36 patients (median age, 78 years; 22 females) Current Awareness in Clinical Toxicology is produced monthly for the American Academy of Clinical Toxicology by the Birmingham Unit of the UK National Poisons Information Service, with contributions from the Cardiff, Edinburgh, and Newcastle Units. The NPIS is commissioned by Public Health England 2 were recruited from 18 hospitals.