Bioanalytical Assay List
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Cleveland Clinic Laboratories
Cleveland Clinic Laboratories Quantitative Urine Pain Management Drug Measurement with HPLC-MS/MS Background Information enzymatic hydrolysis is much milder, but needs longer incubation time to achieve sufficient (>80%) hydrolysis Pain management drugs are among the most prescribed efficiency.7 medications, and they are also the most abused class of prescription drugs.1-2 Therefore, many states including Ohio Cleveland Clinic Laboratories offer an HPLC-MS/MS method have enacted laws governing the prescription of pain for quantitative screening of 11 pain management drugs and management drugs. Patients enrolled in pain management five other commonly abused drugs in urine.8 In this method, programs need to be monitored for compliance, which total drug concentration is measured after enzymatic hydroly- means appropriate use of prescribed drugs and abstinence sis. This assay also includes an adulteration test using urine from non-prescribed drugs. test strips to ensure specimen quality. In addition to pain management, this test can also be used for monitoring Urine is the most commonly used specimen in monitoring patient compliance in rehabilitation programs. pain management and illicit drug use. A single urine specimen can be tested for a number of drugs. Immunoassay (IA) can The high sensitivity of this method is capable of detecting be used as a screening method, but it lacks specificity and drug manufacturing impurities. As an example, codeine is a sensitivity. For example, most immunoassay tests cannot known manufacturing impurity in morphine (~0.04%) and distinguish various opiate drugs and cannot detect oxymor- can be detected by this method.9 3-4 phone at all. -
(12) United States Patent (10) Patent No.: US 8.492,564 B2 Beguin Et Al
USOO8492.564B2 (12) United States Patent (10) Patent No.: US 8.492,564 B2 Beguin et al. (45) Date of Patent: Jul. 23, 2013 (54) SALVINORIN DERIVATIVES AND USES Béguin et al., “Differential signaling properties at the kappa opioid THEREOF receptor of 12-epi-Salvinorin A and its analogues. Bioorg Med Chem Lett. 22: 1023-1026, 2012. (75) Inventors: Cecile Beguin, Lexington, MA (US); Béguin et al., “Modification of the furan ring of salvinorin A: iden Justin Stephen Potuzak, Millis, MA tification of a selective partial agonist at the kappa opioid receptor.” 17: 1370-1380, Epub Dec. 14, 2008. (US); Thomas Anthony Munro, Béguinet al., "N-Methylacetamide Analog of Salvinorin A: A Highly Cambridge, MA (US); Katharine K. Potent and Selective K-Opioid Receptor Agonist with Oral Efficacy.” Duncan, San Diego, CA (US); William J. Pharmacol. Exp. Ther, 324; 188-195 (2008). A. Carlezon, Lincoln, MA (US); Bruce Béguin et al., “Synthesis and In Vitro Evaluation of Salvinorin A M. Cohen, Lexington, MA (US); Analogues: Effect of Configuration at C(2) and Substitution at Lee-yuan Liu-Chen, Media, PA (US) C(18).” Bioorg. Med. Chem. Lett. 16:4679-4685 (2006). Béguin et al., “Synthesis and InVitro Pharmacological Evaluation of (73) Assignees: The McLean Hospital Corporation, Salvinorin A Analogues Modified at C(2).” Bioorg. Med. Chem. Lett. Belmont, MA (US); Temple University 15:2761-2765 (2005). School of Medicine, Philadelphia, PA Bigham et al., “Divinatorins A-C, New Neoclerodane Diterpenoids from the Controlled SageSalvia divinorum,'.J. Nat. Prod 66: 1242 (US) 1244 (2003). Bikbulatov et al., “Short synthesis of a novel class of salvinorin A (*) Notice: Subject to any disclaimer, the term of this analogs with hemiacetalic structure.” Tetrahedron Lett. -
Prescription Drug Management
Check out our new site: www.acllaboratories.com Prescription Drug Management Non Adherence, Drug Misuse, Increased Healthcare Costs Reports from the Centers for DiseasePrescription Control and Prevention (CDC) say Drug deaths from Managementmedication overdose have risen for 11 straight years. In 2008 more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription Nondrugs. Adherence,1 Drug Misuse, Increased Healthcare Costs The CDC analysis found that nearly 40,000 drug overdose deaths were reported in 2010. Prescribed medication accounted for almost 60 percent of the fatalities—far more than deaths from illegal street drugs. Abuse of painkillers like ReportsOxyContin from and the VicodinCenters forwere Disease linked Control to the and majority Prevention of the (CDC) deaths, say deaths from according to the report.1 medication overdose have risen for 11 straight years. In 2008 more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription drugs. 1 A health economics study analyzed managed care claims of more than 18 million patients, finding that patients undergoing opioid therapyThe CDCfor chronic analysis pain found who that may nearly not 40,000 be following drug overdose their prescription deaths were regimenreported in 2010. Prescribed medication accounted for almost 60 percent of the fatalities—far more than deaths have significantly higher overall healthcare costs. from illegal street drugs. Abuse of painkillers like OxyContin and Vicodin were linked to the majority of the deaths, according to the report.1 ACL offers drug management testing to provide information that can aid clinicians in therapy and monitoring to help improve patientA health outcomes. -
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. -
ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update
The ASAM NATIONAL The ASAM National Practice Guideline 2020 Focused Update Guideline 2020 Focused National Practice The ASAM PRACTICE GUIDELINE For the Treatment of Opioid Use Disorder 2020 Focused Update Adopted by the ASAM Board of Directors December 18, 2019. © Copyright 2020. American Society of Addiction Medicine, Inc. All rights reserved. Permission to make digital or hard copies of this work for personal or classroom use is granted without fee provided that copies are not made or distributed for commercial, advertising or promotional purposes, and that copies bear this notice and the full citation on the fi rst page. Republication, systematic reproduction, posting in electronic form on servers, redistribution to lists, or other uses of this material, require prior specifi c written permission or license from the Society. American Society of Addiction Medicine 11400 Rockville Pike, Suite 200 Rockville, MD 20852 Phone: (301) 656-3920 Fax (301) 656-3815 E-mail: [email protected] www.asam.org CLINICAL PRACTICE GUIDELINE The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update 2020 Focused Update Guideline Committee members Kyle Kampman, MD, Chair (alpha order): Daniel Langleben, MD Chinazo Cunningham, MD, MS, FASAM Ben Nordstrom, MD, PhD Mark J. Edlund, MD, PhD David Oslin, MD Marc Fishman, MD, DFASAM George Woody, MD Adam J. Gordon, MD, MPH, FACP, DFASAM Tricia Wright, MD, MS Hendre´e E. Jones, PhD Stephen Wyatt, DO Kyle M. Kampman, MD, FASAM, Chair 2015 ASAM Quality Improvement Council (alpha order): Daniel Langleben, MD John Femino, MD, FASAM Marjorie Meyer, MD Margaret Jarvis, MD, FASAM, Chair Sandra Springer, MD, FASAM Margaret Kotz, DO, FASAM George Woody, MD Sandrine Pirard, MD, MPH, PhD Tricia E. -
LC-MS for Pain Management Support
LC-MS for Pain Management Support Gwen McMillin, PhD, DABCC(CC,TC) University of Utah ARUP Laboratories Outline .Overview of drug testing, as a component of the therapeutic plan, in the management of chronic pain .A mini-SWOT analysis for application of LC- MS to pain management drug testing .Considerations for optimizing utility of LC-MS results Drug testing in pain management . Baseline testing, before initiating opioid therapy . Routine testing . Periodic, based on patient risk assessment . To evaluate changes . Therapeutic plan (drugs, formulations, dosing) . Clinical response (poor pain control, toxicity) . Clinical events (disease, surgery, pregnancy) . Patient behavior Objectives of drug testing Non- Detect and encourage Adherence appropriate drug use Detect and discourage Adherence inappropriate drug use Traditional approach . Immunoassay-based screen Screen . Confirm screen positive results with mass spectrometric method (GC-MS, LC-MS) Not appropriate for pain management Confirm + . Reflex testing leads to unnecessary expenses if the results are consistent with expectations, or if results are not used to make patient care decisions Confirm + . Confirmation of negative results may be more important than confirmation of positive results . Immunoassay-based screens may not be available Confirm + for specimens and drugs of interest Drugs monitored for pain management represent ~25% of “Top 200” prescriptions filled, 2011 .Analgesics .Anxiolytics, muscle . Hydrocodone (#1, 2, 14, 139) relaxants . Oxycodone (#45, 48, 121, 129, 196) -
169 2016 Interim Meeting Science and Public Health - 1
169 2016 Interim Meeting Science and Public Health - 1 REPORTS OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH The following reports, 1–4, were presented by S. Bobby Mukkamala, MD, Chair: 1. URINE DRUG TESTING Reference committee hearing: see report of Reference Committee K. HOUSE ACTION: RECOMMENDATIONS ADOPTED AS FOLLOWS REMAINDER OF REPORT FILED See Policies H-95.985 and D-120.936 INTRODUCTION Over the past two decades, the rate of opioid prescribing, especially for patients with chronic non-cancer pain, has increased dramatically. It is estimated that between 9.6 and 11.5 million Americans are currently being prescribed long-term opioid therapy.1 The overall increase in prescribing has been associated with a parallel increase in unintentional overdoses and deaths from prescription opioids.2 In 2014, a total of 47,055 drug overdose deaths occurred in the United States; 61% of these involved some type of opioid, including heroin. Overdose deaths from heroin have quadrupled in recent years, and the majority of past year users of heroin report they used opioids in a nonmedical fashion prior to heroin initiation; hence, the availability of pharmaceutical opioids is relevant to the national heroin use and overdose death epidemics. In the most recent available report, benzodiazepines were involved in 31% of the opioid-related overdoses.3 Despite clinical recommendations to the contrary, the rate of opioid and benzodiazepine co-prescribing also continues to rise.3-5 Identifying patients at risk for drug misuse is a challenge. There is no definitive way for physicians to predict which of their patients will develop misuse problems with controlled substances. -
(12) Patent Application Publication (10) Pub. No.: US 2004/0024006 A1 Simon (43) Pub
US 2004.0024006A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0024006 A1 Simon (43) Pub. Date: Feb. 5, 2004 (54) OPIOID PHARMACEUTICAL May 30, 1997, now abandoned, and which is a COMPOSITIONS continuation-in-part of application No. 08/643,775, filed on May 6, 1996, now abandoned. (76) Inventor: David Lew Simon, Mansfield Center, CT (US) Publication Classification Correspondence Address: (51) Int. Cl. ................................................ A61K 31/485 David L. Simon (52) U.S. Cl. .............................................................. 514/282 P.O. Box 618 100 Cemetery Road (57) ABSTRACT Mansfield Center, CT 06250 (US) The invention is directed in part to dosage forms comprising a combination of an analgesically effective amount of an (21) Appl. No.: 10/628,089 opioid agonist analgesic and a neutral receptor binding agent or a partial mu-opioid agonist, the neutral receptor binding (22) Filed: Jul. 25, 2003 agent or partial mu-opioid agonist being included in a ratio Related U.S. Application Data to the opioid agonist analgesic to provide a combination product which is analgesically effective when the combina (63) Continuation-in-part of application No. 10/306,657, tion is administered as prescribed, but which is leSS analge filed on Nov. 27, 2002, which is a continuation-in-part Sically effective or less rewarding when administered in of application No. 09/922,873, filed on Aug. 6, 2001, excess of prescription. Preferably, the combination product now Pat. No. 6,569,866, which is a continuation-in affects an opioid dependent individual differently from an part of application No. 09/152,834, filed on Sep. -
2019 Opioid Overdose County-Level Data Tables
Opioid Overdose Surveillance Preliminary County Level Data Tables Georgia, 2019 These data describe fatal (mortality) and nonfatal (morbidity) opioid-involved overdoses in Georgia during 2019, including those related to prescription opioids and illicit opioids such as heroin, fentanyl, and fentanyl analogs. Opioid overdose data were analyzed by the Georgia Department of Public Health (DPH) Epidemiology Program, Drug Surveillance Unit, using Georgia hospitalization and emergency department (ED) visit discharge data, and DPH Vital Records death data. Contents Case Definitions and Data Source Information ....................................................................................................................................................................................... 2 Year-by-Year Data Tables ....................................................................................................................................................................................................................... 5 Demographics Data Tables ...................................................................................................................................................................................................................... 6 County Level Data Tables........................................................................................................................................................................................................................ 7 For more information: • Georgia overdose -
WO 2013/066179 Al 10 May 2013 (10.05.2013) W P O PCT
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2013/066179 Al 10 May 2013 (10.05.2013) W P O PCT (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 9/127 (2006.01) A61P 29/00 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/573 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (21) Number: International Application DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/NL20 12/050766 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 2 November 2012 (02.1 1.2012) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, (25) Filing Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, (26) Publication Language: English TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: PCT/NL201 1/050755 (84) Designated States (unless otherwise indicated, for every 4 November 20 11 (04. 11.20 11) NL kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (71) Applicant: ENCELADUS PHARMACEUTICALS B.V. -
Analysis of Oxycodone and Its Metabolites-Noroxycodone, Oxymorphone, and Noroxymorphone in Plasma by LC/MS with an Agilent ZORBAX Stablebond SB -C18 LC Column
Analysis of Oxycodone and Its Metabolites-Noroxycodone, Oxymorphone, and Noroxymorphone in Plasma by LC/MS with an Agilent ZORBAX StableBond SB -C18 LC Column Application Note Pharmaceutical Authors Abstract Linda L. Risler Oxycodone and its oxidative metabolites (noroxycodone, oxymorphone, and Fred Hutchinson Cancer Research noroxymorphone) were analyzed by high performance liquid chromatography/mass Center, spectrometry (HPLC/MS), coupled with chromatographic separation by an Agilent Seattle, WA 98109 ZORBAX Rapid Resolution High Throughput (RRHT) StableBond SB-C18 column. The method used an ammonium acetate/acetonitrile gradient with detection by a mass Anne E. Mack spectrometer in electrospray mode with positive polarity. Spiked human plasma Agilent Technologies, Inc. samples underwent solid phase extraction (SPE) prior to LC/MS analysis. This method provided good linearity (R 2 > 0.9900) and reproducibility (< 10% difference between duplicates) for all compounds, while increasing productivity with a fast, efficient analysis and minimal solvent usage. Introduction Experimental Oxycodone was developed in 1916 as an opioid analgesic An Agilent 1100 Series LC/MS was used for this work: medication intended to replace the far too addictive analgesic at the time, heroin. Today, oxycodone is a Schedule II drug in • Agilent G1312A Binary Pump. Mobile phase A: 20 mM the US, which means, while it has proven medical uses, it is ammonium acetate, pH 4.0 and B: acetonitrile. Flow rate still considered highly addictive with the possibility of both was 0.300 mL/min. Hold 5% B for 2.33 minutes, then physical and psychological dependencies. Figure 1 shows increase B from 5% to 20% from 2.33 to 4.33 minutes, stop oxycodone and its metabolic scheme, yielding noroxycodone, time is 6 minutes, and post time is 4 minutes. -
Comprehensive Multi-Analytical Screening Of
COMPREHENSIVE MULTI-ANALYTICAL SCREENING OF DRUGS OF ABUSE, INCLUDING NEW PSYCHOACTIVE SUBSTANCES, IN URINE WITH BIOCHIP ARRAYS APPLIED TO THE EVIDENCE ANALYSER Darragh J., Keery L., Keenan R., Stevenson C., Norney G., Benchikh M.E., Rodríguez M.L., McConnell R. I., FitzGerald S.P. Randox Toxicology Ltd., Crumlin, United Kingdom e-mail: [email protected] Introduction Biochip array technology allows the simultaneous detection of multiple drugs from a single undivided sample, which This study summarises the analytical performance of three different biochip arrays applied to the screening of increases the screening capacity and the result output per sample. Polydrug consumption can be detected and by acetylfentanyl, AH-7921, amphetamine, barbiturates, benzodiazepines (including etizolam and clonazepam), incorporating new immunoassays on the biochip surface, this technology has the capacity to adapt to the new trends benzoylecgonine/cocaine, benzylpiperazines, buprenorphine, cannabinoids, carfentanil, dextromethorphan, fentanyl, in the drug market. furanylfentanyl, meprobamate, mescaline, methamphetamine, methadone, mitragynine, MT-45, naloxone, ocfentanyl, opioids, opiates, oxycodone, phencyclidine, phenylpiperazines, salvinorin, sufentanil, synthetic cannabinoids (JWH-018, UR-144, AB-PINACA, AB-CHMINACA), synthetic cathinones [mephedrone, methcathinone, alpha- pyrrolidinopentiophenone (alpha-PVP)], tramadol, tricyclic antidepressants, U-47700, W-19, zolpidem. Methodology Three different biochip arrays were used (DOA ULTRA,