August 2021 California Signaturevalue 4 Tier HMO Formulary
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The National Drugs List
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Guidelines for the Forensic Analysis of Drugs Facilitating Sexual Assault and Other Criminal Acts
Vienna International Centre, PO Box 500, 1400 Vienna, Austria Tel.: (+43-1) 26060-0, Fax: (+43-1) 26060-5866, www.unodc.org Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts United Nations publication Printed in Austria ST/NAR/45 *1186331*V.11-86331—December 2011 —300 Photo credits: UNODC Photo Library, iStock.com/Abel Mitja Varela Laboratory and Scientific Section UNITED NATIONS OFFICE ON DRUGS AND CRIME Vienna Guidelines for the forensic analysis of drugs facilitating sexual assault and other criminal acts UNITED NATIONS New York, 2011 ST/NAR/45 © United Nations, December 2011. 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. This publication has not been formally edited. Publishing production: English, Publishing and Library Section, United Nations Office at Vienna. List of abbreviations . v Acknowledgements .......................................... vii 1. Introduction............................................. 1 1.1. Background ........................................ 1 1.2. Purpose and scope of the manual ...................... 2 2. Investigative and analytical challenges ....................... 5 3 Evidence collection ...................................... 9 3.1. Evidence collection kits .............................. 9 3.2. Sample transfer and storage........................... 10 3.3. Biological samples and sampling ...................... 11 3.4. Other samples ...................................... 12 4. Analytical considerations .................................. 13 4.1. Substances encountered in DFSA and other DFC cases .... 13 4.2. Procedures and analytical strategy...................... 14 4.3. Analytical methodology .............................. 15 4.4. -
Acetadote (Acetylcysteine) Injection Is Available As a 20% Solution in 30 Ml (200Mg/Ml) Single Dose Glass Vials
NDA 21-539/S-004 Page 3 Acetadote® (acetylcysteine) Injection Package Insert NDA 21-539/S-004 Page 4 RX ONLY PRESCRIBING INFORMATION ACETADOTE® (acetylcysteine) Injection For Intravenous Use DESCRIPTION Acetylcysteine injection is an intravenous (I.V.) medication for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine, NAC). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula: H CH3 N SH O COOH Acetadote is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetadote contains the following inactive ingredients: 0.5 mg/mL disodium edetate, sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP. CLINICAL PHARMACOLOGY Acetaminophen Overdose: Acetaminophen is absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. It is extensively metabolized in the liver to form principally the sulfate and glucoronide conjugates which are excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by isozyme CYP2E1 of the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite. The toxic metabolite preferentially conjugates with hepatic glutathione to form nontoxic cysteine and mercapturic acid derivatives, which are then excreted by the kidney. -
The Promise of N-Acetylcysteine in Neuropsychiatry
Review The promise of N-acetylcysteine in neuropsychiatry 1,2,3,4 5,6 1 1,2,4 Michael Berk , Gin S. Malhi , Laura J. Gray , and Olivia M. Dean 1 School of Medicine, Deakin University, Geelong, Victoria, Australia 2 Department of Psychiatry, University of Melbourne, Parkville, Victoria, Australia 3 Orygen Research Centre, Parkville, Victoria, Australia 4 The Florey Institute of Neuroscience and Mental Health, Victoria, Australia 5 Discipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, Australia 6 CADE Clinic, Department of Psychiatry, Level 5 Building 36, Royal North Shore Hospital, St Leonards, 2065, Australia N-Acetylcysteine (NAC) targets a diverse array of factors with the pathophysiology of a diverse range of neuropsy- germane to the pathophysiology of multiple neuropsy- chiatric disorders, including autism, addiction, depression, chiatric disorders including glutamatergic transmission, schizophrenia, bipolar disorder, and Alzheimer’s and Par- the antioxidant glutathione, neurotrophins, apoptosis, kinson’s diseases [3]. Determining precisely how NAC mitochondrial function, and inflammatory pathways. works is crucial both to understanding the core biology This review summarises the areas where the mecha- of these illnesses, and to opening the door to other adjunc- nisms of action of NAC overlap with known pathophysi- tive therapies operating on these pathways. The current ological elements, and offers a pre´ cis of current literature article will initially review the possible mechanisms of regarding the use of NAC in disorders including cocaine, action of NAC, and then critically appraise the evidence cannabis, and smoking addictions, Alzheimer’s and Par- that suggests it has efficacy in the treatment of neuropsy- kinson’s diseases, autism, compulsive and grooming chiatric disorders. -
TACHOSIL (Fibrin Sealant Patch)
Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMORANDUM To: Craig Zinderman, MD, MPH Acting Director, Division of Epidemiology (DE) Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER) Through: Meghna Alimchandani, MD Associate Director for Medical Policy, OBE, CBER From: Faith Barash, MD, MPH Medical Officer, Pharmacovigilance Branch Office of Biostatistics and Epidemiology (OBE) Center for Biologics Evaluation and Research (CBER) Subject: Safety and Utilization Review for the Pediatric Advisory Committee Applicant: Takeda Pharma A/S Product: TACHOSIL (Fibrin Sealant Patch) STN: 125351/279 Indication: TACHOSIL is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Meeting Date: Pediatric Advisory Committee Meeting, September 2019 1 Contents 1 INTRODUCTION ................................................................................................................................ 3 1.1 Objective ...................................................................................................................................... 3 1.2 Product Description .................................................................................................................... 3 1.3 Regulatory -
Migraine Specialty Care Program Tm
MIGRAINE SPECIALTY CARE PROGRAM TM Phone: 833-796-6470 • Fax: 844-841-3401 Community Led Specialty Pharmacy Care 1 PATIENT INFORMATION: 2 PRESCRIBER INFORMATION: Name: ___________________________________________________ Name: ___________________________________________________ Address: _________________________________________________ Address: _________________________________________________ City: _________________________ State: ____ Zip: ____________ City: _________________________ State: ____ Zip: ____________ Phone: ___________________ Alt. Phone: ____________________ Phone: _____________________ Fax: _______________________ Email: ____________________________________________________ NPI: ________________________ DEA: _______________________ DOB: ___________ Gender: M F Caregiver: _____________ Tax I.D.: __________________________________________________ Height: ________ Weight: ________ Allergies: ________________ Office Contact: __________________ Phone: __________________ 3 STATEMENT OF MEDICAL NECESSITY: (Please Attach All Medical Documentation) Prior Failed Indicate Drug Name v10.0_060821 Length of Symptoms: ___________________________ ICD-10: _________________________ Treatments: and Length of Treatment: Other diagnosis _______________ Number of Migraine Days per month: ________________ Preventative: Headache Days per month: _________________ Migraine Hours per day: __________________ ACE-I/ARBs ___________________ Patient has been evaluated and does not have medication overuse headache? No Yes Antiepileptics ___________________ -
(Acetylcysteine) Effervescent Tablets for Oral Solution Intratracheal Instillation Initial U.S
HIGHLIGHTS OF PRESCRIBING INFORMATION • See the Full Prescribing Information for instructions on how to use the These highlights do not include all the information needed to use nomogram to determine the need for loading and maintenance dosing. CETYLEV® safely and effectively. See full prescribing information for CETYLEV. Recommended Adult and Pediatric Dosage (2.3): • CETYLEV is for oral administration only; not for nebulization or CETYLEV (acetylcysteine) effervescent tablets for oral solution intratracheal instillation Initial U.S. Approval: 1963 • Loading dose: 140 mg/kg • Maintenance doses: 70 mg/kg repeated every 4 hours for a total of 17 ----------------------------INDICATIONS AND USAGE--------------------------- doses. CETYLEV is an antidote for acetaminophen overdose indicated to prevent or • lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of See Full Prescribing Information for weight-based dosage and preparation acetaminophen in patients with acute ingestion or from repeated and administration instructions. supratherapeutic ingestion. (1) Repeated Supratherapeutic Acetaminophen Ingestion (2.4): -----------------------DOSAGE AND ADMINISTRATION----------------------- • Obtain acetaminophen concentration and other laboratory tests to guide Pre-Treatment Assessment Following Acute Ingestion (2.1): treatment; Rumack-Matthew nomogram does not apply. Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion. ----------------------DOSAGE FORMS AND STRENGTHS--------------------- -
Updatirg the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults
Updatirg the BeersCriteria for Potentially InappropriateMedication Use in Older Adults Resultsof a US ConsensusPanel of Experts DonnaM.Fich,PhD,RN;lamesW.Cooper,PhD,RPh;WilliamE.Wade,PhannD,FASHP,FCCP; JenniJerL. Waller, PhD;J, RossMaclean, MD; Marh H. Beers,MD Bcckground: Medication toxic effectsand drug- Reruhr: This study identified 48 individual medica- relatedproblems can have profound medical and safety tions or classeso[ medicationsto avoid in older adults consequencesfor older adults and economically affect the and their potential concernsand 20 diseases/conditions health caresystem. The purpose of this initiative was to and medicationsto be avoidedin older adultswith these reviseand update the Beerscriteria for potentially inap- conditions.Of thesepotentially inappropriate drugs, 66 propriate medicationuse in adults 65 yearsand older in wereconsidered by the panelto haveadverse outcomes the United States. of high severity. lYlcthcdr: This study used a modified Delphi method, a Concludonr: This study is an importantupdate of pre- setof proceduresand methodsfor formulating a groupjudg- viously establishedcriteria that have been widely used ment for a subject matter in which precise information is and cited. The application of the Beerscriteria and other Iacking. The criteria reviewed covered 2 types of state- tools for identifying potentially inapproprlate medica- ments: (l) medicationsor medicationclasses that should tion use will continue to enableproviders to plan inter- grnerally be avoidedin persons 65 years or older because -
Use of Fluorescence to Guide Resection Or Biopsy of Primary Brain Tumors and Brain Metastases
Neurosurg Focus 36 (2):E10, 2014 ©AANS, 2014 Use of fluorescence to guide resection or biopsy of primary brain tumors and brain metastases *SERGE MARBACHER, M.D., M.SC.,1,5 ELISABETH KLINGER, M.D.,2 LUCIA SCHWYZER, M.D.,1,5 INGEBORG FISCHER, M.D.,3 EDIN NEVZATI, M.D.,1 MICHAEL DIEPERS, M.D.,2,5 ULRICH ROELCKE, M.D.,4,5 ALI-REZA FATHI, M.D.,1,5 DANIEL COLUCCIA, M.D.,1,5 AND JAVIER FANDINO, M.D.1,5 Departments of 1Neurosurgery, 2Neuroradiology, 3Pathology, and 4Neurology, and 5Brain Tumor Center, Kantonsspital Aarau, Aarau, Switzerland Object. The accurate discrimination between tumor and normal tissue is crucial for determining how much to resect and therefore for the clinical outcome of patients with brain tumors. In recent years, guidance with 5-aminolev- ulinic acid (5-ALA)–induced intraoperative fluorescence has proven to be a useful surgical adjunct for gross-total resection of high-grade gliomas. The clinical utility of 5-ALA in resection of brain tumors other than glioblastomas has not yet been established. The authors assessed the frequency of positive 5-ALA fluorescence in a cohort of pa- tients with primary brain tumors and metastases. Methods. The authors conducted a single-center retrospective analysis of 531 patients with intracranial tumors treated by 5-ALA–guided resection or biopsy. They analyzed patient characteristics, preoperative and postoperative liver function test results, intraoperative tumor fluorescence, and histological data. They also screened discharge summaries for clinical adverse effects resulting from the administration of 5-ALA. Intraoperative qualitative 5-ALA fluorescence (none, mild, moderate, and strong) was documented by the surgeon and dichotomized into negative and positive fluorescence. -
Potentially Harmful Drugs in the Elderly: Beers List
−This Clinical Resource gives subscribers additional insight related to the Recommendations published in− March 2019 ~ Resource #350301 Potentially Harmful Drugs in the Elderly: Beers List In 1991, Dr. Mark Beers and colleagues published a methods paper describing the development of a consensus list of medicines considered to be inappropriate for long-term care facility residents.12 The “Beers list” is now in its sixth permutation.1 It is intended for use by clinicians in outpatient as well as inpatient settings (but not hospice or palliative care) to improve the care of patients 65 years of age and older.1 It includes medications that should generally be avoided in all elderly, used with caution, or used with caution or avoided in certain elderly.1 There is also a list of potentially harmful drug-drug interactions in seniors, as well as a list of medications that may need to be avoided or have their dosage reduced based on renal function.1 This information is not comprehensive; medications and interactions were chosen for inclusion based on potential harm in relation to benefit in the elderly, and availability of alternatives with a more favorable risk/benefit ratio.1 The criteria no longer address drugs to avoid in patients with seizures or insomnia because these concerns are not unique to the elderly.1 Another notable deletion is H2 blockers as a concern in dementia; evidence of cognitive impairment is weak, and long-term PPIs pose risks.1 Glimepiride has been added as a drug to avoid. Some drugs have been added with cautions (dextromethorphan/quinidine, trimethoprim/sulfamethoxazole), and some have had cautions added (rivaroxaban, tramadol, SNRIs). -
California Essential Drug List
California Essential Drug List The Essential Drug List (formulary) includes a list of drugs covered by Health Net. The drug list is updated at least monthly and is subject to change. All previous versions are no longer in effect. You can view the most current drug list by going to our website at www.healthnet.com. Refer to Evidence of Coverage or Certificate of Insurance for specific cost share information. For California Individual & Family Plans: Drug Lists Select Health Net Large Group – Formulary (pdf). For Small Business Group: Drug Lists Select Health Net Small Business Group – Formulary (pdf). NOTE: To search the drug list online, open the (pdf) document. Hold down the “Control” (Ctrl) and “F” keys. When the search box appears, type the name of your drug and press the “Enter” key. If you have questions or need more information call us toll free. California Individual & Family Plans (off-Exchange) If you have questions about your pharmacy coverage call Customer Service at 1-800-839-2172 California Individual & Family Plans (on-Exchange) If you have questions about your pharmacy coverage call Customer Service at 1-888-926-4988 Hours of Operation 8:00am – 7:00pm Monday through Friday 8:00am – 5:00pm Saturday Small Business Group If you have questions about your pharmacy coverage call Customer Service at 1-800-361-3366 Hours of Operation 8:00am – 6:00pm Monday through Friday Updated September 1, 2021 Health Net of California, Inc. and Health Net Life Insurance Company are subsidiaries of Health Net, LLC and Centene Corporation. Health Net is a registered service mark of Health Net, LLC Table of Contents What If I Have Questions Regarding My Pharmacy Benefit? ................................... -
DDT Cover/Back April 2006.Qx
March 2007 Vol 7 No 3 www.drugdeliverytech.com IN THIS ISSUE INTERVIEW WITH DPT’S PRESIDENT MR. PAUL JOHNSON In Situ Gel Systems 30 Mitan Gokulgandhi, BPharm Dharmesh M. Modi, MPharm COX-II Microspheres 38 Lakshmi Sivasubramanian Madhumathi Seshadri Undermining CEO’s 82 John A. Bermingham FEATURING Parkinson’s Disease 59 Steven Damon Yogi R. Patel The science & business of specialty pharma, biotechnology, and drug delivery Specialty Pharma Indices 64 Dr. Barath Christopher Avani Amin, Josef Bossart, PhD Shankar Robinson, PhD Drug Delivery’s PhD Current Status of Clinical Trials Increasing New Ways to Non-Invasive In Asia 68 Importance to Partner With Insulin Delivery Ames Gross, MBA Big Pharma & the Federal Technologies Specialty Pharma Government Momoko Hirose March 2007 Vol 7 No 3 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Fax: (703) 548-3733 E-mail: [email protected] E-mail: [email protected] West Coast Warren