SB0170S01* Money Appropriated in This Bill: Other Special Clauses: Utah Code Sections Af AMENDS: Administration and Contain a Component of Cannabis
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Drug Use Evaluation: Antipsychotic Utilization in Schizophrenia Patients
© Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Drug Use Evaluation: Antipsychotic Utilization in Schizophrenia Patients Research Questions: 1. How many schizophrenia patients are prescribed recommended first-line second-generation treatments for schizophrenia? 2. How many schizophrenia patients switch to an injectable antipsychotic after stabilization on an oral antipsychotic? 3. How many schizophrenia patients are prescribed 2 or more concomitant antipsychotics? 4. Are claims for long-acting injectable antipsychotics primarily billed as pharmacy or physician administered claims? 5. Does adherence to antipsychotic therapy differ between patients with claims for different routes of administration (oral vs. long-acting injectable)? Conclusions: In total, 4663 schizophrenia patients met inclusion criteria, and approximately 14% of patients (n=685) were identified as treatment naïve without claims for antipsychotics in the year before their first antipsychotic prescription. Approximately 45% of patients identified as treatment naïve had a history of remote antipsychotic use, but it is unclear if antipsychotics were historically prescribed for schizophrenia. Oral second-generation antipsychotics which are recommended as first-line treatment in the MHCAG schizophrenia algorithm were prescribed as initial treatment in 37% of treatment naive patients and 28% of all schizophrenia patients. Recommended agents include risperidone, paliperidone, and aripiprazole. Utilization of parenteral antipsychotics was limited in patients with schizophrenia. Overall only 8% of patients switched from an oral to an injectable therapy within 6 months of their first claim. Approximately, 60% of all schizophrenia patients (n=2512) had claims for a single antipsychotic for at least 12 continuous weeks and may be eligible to transition to a long-acting injectable antipsychotic. -
Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment for Schizophrenia in Adult Patients? Kyle J
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Student Dissertations, Theses and Papers Scholarship 2017 Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles Philadelphia College of Osteopathic Medicine Follow this and additional works at: https://digitalcommons.pcom.edu/pa_systematic_reviews Part of the Psychiatry Commons Recommended Citation Knowles, Kyle J., "Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients?" (2017). PCOM Physician Assistant Studies Student Scholarship. 381. https://digitalcommons.pcom.edu/pa_systematic_reviews/381 This Selective Evidence-Based Medicine Review is brought to you for free and open access by the Student Dissertations, Theses and Papers at DigitalCommons@PCOM. It has been accepted for inclusion in PCOM Physician Assistant Studies Student Scholarship by an authorized administrator of DigitalCommons@PCOM. For more information, please contact [email protected]. Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles, PA-S A SELECTIVE EVIDENCE BASED MEDICINE REVIEW In Partial Fulfillment of the Requirements For The Degree of Master of Science In Health Sciences- Physician Assistant Department of Physician Assistant Studies Philadelphia College of Osteopathic Medicine Philadelphia, Pennsylvania December 16, 2016 ABSTRACT OBJECTIVE: The objective of this selective EBM review is to determine whether or not “Is Aristada (aripiprazole lauroxil) a safe and effective treatment for schizophrenia in adult patients?” STUDY DESIGN: Review of three randomized controlled studies. All three trials were conducted between 2014 and 2015. DATA SOURCES: One randomized, controlled trial and two randomized, controlled, double- blind trials found via Cochrane Library and PubMed. -
Telazol® CIII(Tiletamine and Zolazepam for Injection)
TELAZOL- tiletamine hydrochloride and zolazepam hydrochloride injection, powder, for solution Zoetis Inc. ---------- Telazol® CIII (tiletamine and zolazepam for injection) 100 mg/mL total (equivalent to 50 mg/mL tiletamine and 50 mg/mL zolazepam) For Intramuscular and Intravenous injection in Dogs For Intramuscular injection only in Cats CAUTION Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION TELAZOL (tiletamine and zolazepam for injection) is a nonnarcotic, nonbarbiturate, injectable anesthetic agent for dogs and cats. Chemically, TELAZOL is a combination of equal parts by weight of base of tiletamine hydrochloride (2-[ethylamino]-2-[2-thienyl]-cyclohexanone hydrochloride), an arylaminocycloalkanone dissociative anesthetic, and zolazepam hydrochloride (4-[o-fluorophenyl]-6, 8-dihydro-1,3,8- trimethylpyrazolo [3, 4-e][1,4] diazepin-7 [1H]-1- hydrochloride), a nonphenothiazine diazepinone having minor tranquilizing properties. The product is supplied sterile in vials. The addition of 5 mL diluent produces a solution containing the equivalent of 50 mg tiletamine base, 50 mg zolazepam base and 57.7 mg mannitol per milliliter. This solution has a pH of 2 to 3.5 and is recommended for deep intramuscular injection. INDICATIONS Dogs TELAZOL is indicated in dogs for restraint and minor procedures of short duration (30 min. avg.) requiring mild to moderate analgesia. Minor surgery is considered to be laceration repair, draining of abscesses, castrations and other procedures requiring mild to moderate analgesia. (See Dogs under Dosage and Administration.) TELAZOL administered intravenously is indicated in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. Cats TELAZOL is indicated in cats for restraint or for anesthesia combined with muscle relaxation. -
124.210 Schedule IV — Substances Included. 1
1 CONTROLLED SUBSTANCES, §124.210 124.210 Schedule IV — substances included. 1. Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. 2. Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below: a. Not more than one milligram of difenoxin and not less than twenty-five micrograms of atropine sulfate per dosage unit. b. Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2- propionoxybutane). c. 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, optical and geometric isomers and salts of these isomers (including tramadol). 3. Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation: a. Alprazolam. b. Barbital. c. Bromazepam. d. Camazepam. e. Carisoprodol. f. Chloral betaine. g. Chloral hydrate. h. Chlordiazepoxide. i. Clobazam. j. Clonazepam. k. Clorazepate. l. Clotiazepam. m. Cloxazolam. n. Delorazepam. o. Diazepam. p. Dichloralphenazone. q. Estazolam. r. Ethchlorvynol. s. Ethinamate. t. Ethyl Loflazepate. u. Fludiazepam. v. Flunitrazepam. w. Flurazepam. x. Halazepam. y. Haloxazolam. z. Ketazolam. aa. Loprazolam. ab. Lorazepam. ac. Lormetazepam. ad. Mebutamate. ae. Medazepam. af. Meprobamate. ag. Methohexital. ah. Methylphenobarbital (mephobarbital). -
Drug Screening: Actual Status, Pitfalls and Suggestions for Improvement Drogenscreening: Gegenwa¨ Rtiger Stand, Fehlermo¨ Glichkeiten Und Verbesserungsvorschla¨Ge
J Lab Med 2004;28(4):317–325 ᮊ 2004 by Walter de Gruyter • Berlin • New York 2004/03304 Drug Monitoring und Toxikologie Redaktion: V. W. Armstrong Drug screening: Actual status, pitfalls and suggestions for improvement Drogenscreening: Gegenwa¨ rtiger Stand, Fehlermo¨ glichkeiten und Verbesserungsvorschla¨ge Wolf R. Ku¨ lpmann* pretierbar. In Wirklichkeit mu¨ ssen viele Aspekte beru¨ ck- sichtigt werden, um einen aussagekra¨ ftigen Befund zu Klinische Chemie, Medizinische Hochschule Hannover, erhalten, z.B. Pra¨ analytik, Spezifita¨ t und Empfindlichkeit Hannover, Germany des Verfahrens oder Qualita¨ tssicherung. Obwohl die Abstract mechanisierten Meßverfahren naturgema¨ ß quantitative Ergebnisse liefern, wird aufgezeigt, daß es sich in der Immunoassays for drug screening are often regarded as Regel empfiehlt, qualitative Befunde zu erstellen. Die procedures which are easily performed and interpreted. Verfahren erlauben aber im Gegensatz zu den auch fu¨r But in fact, many aspects have to be considered to diese Zwecke verwendeten Teststreifen die Entschei- obtain a meaningful result. Among these are sampling, dungsgrenze (cut-off) der jeweiligen Fragestellung anzu- specificity and sensitivity of assays, and quality assess- passen, z.B. bei akuter Intoxikation, chronischem Abusus ment. Although the mechanised procedures yield quan- oder U¨ berwachung des Drogenentzugs. titative results, there are good reasons to generally report Ein schwerwiegender Nachteil von Immunoassays zum qualitative findings. The mechanised procedures allow Nachweis von Amphetamin und a¨ hnlichen Substanzen, the adjustment of the cut-off concentration to the clinical Barbituraten, Benzodiazepinen und Opiaten besteht dar- setting, e.g. in the case of acute intoxication, chronic in, daß eine starke Kreuzreaktivita¨ t des Antiko¨ rpers abuse or drug withdrawal, an important advantage as gegenu¨ ber pharmakologisch wenig wirksamen Verbin- compared to test strips. -
Veterinary Anesthetic and Analgesic Formulary 3Rd Edition, Version G
Veterinary Anesthetic and Analgesic Formulary 3rd Edition, Version G I. Introduction and Use of the UC‐Denver Veterinary Formulary II. Anesthetic and Analgesic Considerations III. Species Specific Veterinary Formulary 1. Mouse 2. Rat 3. Neonatal Rodent 4. Guinea Pig 5. Chinchilla 6. Gerbil 7. Rabbit 8. Dog 9. Pig 10. Sheep 11. Non‐Pharmaceutical Grade Anesthetics IV. References I. Introduction and Use of the UC‐Denver Formulary Basic Definitions: Anesthesia: central nervous system depression that provides amnesia, unconsciousness and immobility in response to a painful stimulation. Drugs that produce anesthesia may or may not provide analgesia (1, 2). Analgesia: The absence of pain in response to stimulation that would normally be painful. An analgesic drug can provide analgesia by acting at the level of the central nervous system or at the site of inflammation to diminish or block pain signals (1, 2). Sedation: A state of mental calmness, decreased response to environmental stimuli, and muscle relaxation. This state is characterized by suppression of spontaneous movement with maintenance of spinal reflexes (1). Animal anesthesia and analgesia are crucial components of an animal use protocol. This document is provided to aid in the design of an anesthetic and analgesic plan to prevent animal pain whenever possible. However, this document should not be perceived to replace consultation with the university’s veterinary staff. As required by law, the veterinary staff should be consulted to assist in the planning of procedures where anesthetics and analgesics will be used to avoid or minimize discomfort, distress and pain in animals (3, 4). Prior to administration, all use of anesthetics and analgesic are to be approved by the Institutional Animal Care and Use Committee (IACUC). -
Second-Generation Long-Acting Injectable Antipsychotics: a PRACTICAL GUIDE Understanding Each of These Medications’ Unique Properties Can Optimize Patient Care
Second-generation long-acting injectable antipsychotics: A PRACTICAL GUIDE Understanding each of these medications’ unique properties can optimize patient care Brittany L. Parmentier, PharmD, MPH, here are currently 7 FDA-approved second-generation long-acting BCPS, BCPP 1-7 Clinical Assistant Professor injectable antipsychotics (LAIAs). These LAIAs provide a Department of Pharmacy Practice Tunique dosage form that allows patients to receive an antipsy- The University of Texas at Tyler Fisch College of Pharmacy chotic without taking oral medications every day, or multiple times per Tyler, Texas day. This may be an appealing option for patients and clinicians, but Disclosure The author reports no financial relationships with any because there are several types of LAIAs available, it may be difficult to companies whose products are mentioned in this article, or with determine which LAIA characteristics are best for a given patient. manufacturers of competing products. Since the FDA approved the first second-generation LAIA, risperidone long-acting injectable (LAI),1 in 2003, 6 additional second-generation LAIAs have been approved: • aripiprazole LAI • aripiprazole lauroxil LAI • olanzapine pamoate LAI • paliperidone palmitate monthly injection • paliperidone palmitate 3-month LAI • risperidone LAI for subcutaneous (SQ) injection. When discussing medication options with patients, clinicians need to consider factors that are unique to each LAIA. In this article, I describe the similarities and differences among the second-generation LAIAs, and address common questions about these medications. A major potential benefit: Increased adherence One potential benefit of all LAIAs is increased medication adherence com- pared with oral antipsychotics. One meta-analysis of 21 randomized con- trolled trials (RCTs) that compared LAIAs with oral antipsychotics and Current Psychiatry GEORGE MATTEI/SCIENCE SOURCE GEORGE MATTEI/SCIENCE Vol. -
Should Inverse Agonists Be Defined by Pharmacological Mechanism Or
CNS Spectrums,(2019), 24 419 – 425. © Cambridge University Press 2018. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. doi:10.1017/S1092852918000986 ORIGINAL RESEARCH Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period Peter J. Weiden,1* Yangchun Du,2 Chih-Chin Liu,2 and Arielle D. Stanford3 1 Medical Affairs, Alkermes, Inc., Waltham, Massachusetts, USA 2 Clinical Development, Alkermes, Inc., Waltham, Massachusetts, USA 3 Clinical Science, Alkermes, Inc., Waltham, Massachusetts, USA Objective. Switching antipsychotic medications is common in patients with schizophrenia who are experiencing persistent symptoms or tolerability issues associated with their current drug regimen. This analysis assessed the safety of switching from an oral antipsychotic to the long-acting injectable antipsychotic aripiprazole lauroxil (AL). Methods. This was a post hoc analysis of outpatients with schizophrenia who were prescribed an oral antipsychotic and who enrolled in an international, open-label, long-term (52-week) safety study of AL. The analysis focused on the first 3 injections of AL 882 mg over 12 weeks, divided into the immediate 4-week crossover period between the first and second AL injections (initiation phase) and the subsequent 8 weeks (stabilization phase). Patients were grouped by preswitch oral antipsychotic medication, and safety and clinical symptoms were assessed. Results. In total, 190 patients had switched from one of the following oral antipsychotic medications: aripiprazole, conventional antipsychotics, risperidone/paliperidone, olanzapine, or quetiapine. -
Introduced B.,Byhansen, 16
LB301 LB301 2021 2021 LEGISLATURE OF NEBRASKA ONE HUNDRED SEVENTH LEGISLATURE FIRST SESSION LEGISLATIVE BILL 301 Introduced by Hansen, B., 16. Read first time January 12, 2021 Committee: Judiciary 1 A BILL FOR AN ACT relating to the Uniform Controlled Substances Act; to 2 amend sections 28-401, 28-405, and 28-416, Revised Statutes 3 Cumulative Supplement, 2020; to redefine terms; to change drug 4 schedules and adopt federal drug provisions; to change a penalty 5 provision; and to repeal the original sections. 6 Be it enacted by the people of the State of Nebraska, -1- LB301 LB301 2021 2021 1 Section 1. Section 28-401, Revised Statutes Cumulative Supplement, 2 2020, is amended to read: 3 28-401 As used in the Uniform Controlled Substances Act, unless the 4 context otherwise requires: 5 (1) Administer means to directly apply a controlled substance by 6 injection, inhalation, ingestion, or any other means to the body of a 7 patient or research subject; 8 (2) Agent means an authorized person who acts on behalf of or at the 9 direction of another person but does not include a common or contract 10 carrier, public warehouse keeper, or employee of a carrier or warehouse 11 keeper; 12 (3) Administration means the Drug Enforcement Administration of the 13 United States Department of Justice; 14 (4) Controlled substance means a drug, biological, substance, or 15 immediate precursor in Schedules I through V of section 28-405. 16 Controlled substance does not include distilled spirits, wine, malt 17 beverages, tobacco, hemp, or any nonnarcotic substance if such substance 18 may, under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. -
Outline for Controlled Substances Program
Environmental Health and Safety Controlled Substances Program Date of Issuance: Review Date: 10/1/2019 (no changes) 10/01/2018 Revision Number: Initial Prepared by: EH&S Table of Contents HEADINGS Introduction Applicability Responsibilities Registration Requirements Authorized Use Ordering/Purchasing Administering and Dispensing Inventory Procedures (Continuing Records) Security Disposal FORMS: Registering or renewing a DEA or state license (CMU) Controlled Substances Authorized users list (CMU) Employee questionnaire for those with access to controlled substances (CMU) Record of Form 222 use (Order form) (CMU) Records of Controlled Substance Purchases (CMU) Record of Controlled Substance Administering and dispensing (CMU) Controlled Substance Physical Inventory (CMU) DEA Registration of Persons doing research or analysis (Form 225) DEA Registration of Dispensers (Form 224) DEA Registration Instructional (Form 224 and 226 to renew) DEA Report of loss or theft (Form 106) DEA Report of drugs surrendered (From 41) DEA SCHEDULES: Schedule I Schedule II Schedule III Schedule IV Schedule V INTRODUCTION State and Federal regulations have been promulgated concerning the use and handling of US Department of Justice Drug Enforcement Administration (DEA) controlled substances. These regulations are in place to address materials which are or have the potential to be addictive or habit forming. These substances have been categorized into “schedules” that have been created by the DEA to reflect their level of concern. The “Carnegie Mellon University DEA Controlled Substances Program” is intended to ensure that Carnegie Mellon University is in compliance with our regulatory requirements. Required activities under the DEA include: 1. Registration of your work with the DEA and with Carnegie Mellon’s Department of Environmental Health and Safety (EH&S). -
Aristada Initio (Aripiprazole Lauroxil), in Combination with Oral Aripiprazole for the Initiation of Aristada When Used for the Treatment of Schizophrenia in Adults
Aristada Initio™ (aripiprazole lauroxil) – New drug approval • On July 2, 2018, Alkermes announced the FDA approval of Aristada Initio (aripiprazole lauroxil), in combination with oral aripiprazole for the initiation of Aristada when used for the treatment of schizophrenia in adults. — The approval of Aristada Initio provides physicians with an alternative regimen to initiate patients onto any dose of Aristada injection on day 1. — Previously, the first Aristada injection was recommended in conjunction with oral aripiprazole for 21 consecutive days. • Oral aripiprazole is generically available as tablets, disintegrating tablets, and solution. Aripiprazole is also available as Abilify Maintena®, a brand extended-release injectable suspension. — The oral formulations are approved for the treatment of schizophrenia and other indications as outlined in the individual drug labels. — Abilify Maintena is indicated for the treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults. • Aristada Initio leverages Alkermes’ proprietary NanoCrystal® technology, which provides an extended-release formulation using a smaller particle size compared to Aristada, thereby enabling faster dissolution and more rapid achievement of relevant drug levels. • The effectiveness of Aristada Initio, in combination with oral aripiprazole and for the initiation of Aristada injection, was established by adequate and well-controlled studies of oral aripiprazole and Aristada injection in adult patients with schizophrenia. -
Report on the Investigation Results
Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. Report on the Investigation Results February 28, 2017 Pharmaceuticals and Medical Devices Agency I. Overview of Product [Non-proprietary name] See Attachment 1 [Brand name] See Attachment 1 [Approval holder] See Attachment 1 [Indications] See Attachment 1 [Dosage and administration] See Attachment 1 [Investigating office] Office of Safety II 1 Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. II. Background of the investigation 1. Status in Japan Hypnotics and anxiolytics are prescribed by various specialties and widely used in clinical practice. In particular, benzodiazepine (BZ) receptor agonists, which act on BZ receptors, bind to gamma-aminobutyric acid (GABA)A-BZ receptor complex and enhance the function of GABAA receptors. This promotes neurotransmission of inhibitory systems and demonstrates hypnotic/sedative effects, anxiolytic effects, muscle relaxant effects, and antispasmodic effects. Since the approval of chlordiazepoxide in March 1961, many BZ receptor agonists have been approved as hypnotics and anxiolytics. Currently, hypnotics and anxiolytics are causative agents of drug-related disorders such as drug dependence in Japanese clinical practice. Hypnotics and anxiolitics that rank high in causative agents are BZ receptor agonists for which high frequencies of high doses and multidrug prescriptions have been reported (Japanese Journal of Clinical Psychopharmacology 2013; 16(6): 803-812, Modern Physician 2014; 34(6): 653-656, etc.).