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(KPIC) PPO and Out-Of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier
Kaiser Permanente Insurance Company (KPIC) PPO and Out-of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier This Drug Formulary was updated: September 1, 2021 NOTE: This drug formulary is updated often and is subject to change. Upon revision, all previous versions of the drug formulary are no longer in effect. This document contains information regarding the drugs that are covered when you participate in the California Nongrandfathered PPO and Out-of- Area Indemnity (OOA) Health Insurance Plans with specialty drug tier offered by Kaiser Permanente Insurance Company (KPIC) and fill your prescription at a MedImpact network pharmacy. Access to the most current version of the Formulary can be obtained by visiting kp.org/kpic-ca-rx-ppo-ngf. For help understanding your KPIC insurance plan benefits, including cost sharing for drugs under the prescription drug benefit and under the medical benefit, please call 1-800-788-0710 or 711 (TTY) Monday through Friday, 7a.m. to 7p.m. For help with this Formulary, including the processes for submitting an exception request and requesting prior authorization and step therapy exceptions, please call MedImpact 24 hours a day, 7 days a week, at 1-800-788-2949 or 711 (TTY). For cost sharing information for the outpatient prescription drug benefits in your specific plan, please visit: kp.org/kpic-ca-rx-ppo-ngf. For help in your preferred language, please see the Kaiser Permanente Insurance Company Notice of Language Assistance in this document. KPIC PPO NGF Table of Contents Informational Section................................................................................................................................2 -
Use of Antipsychotic Medications in Nursing Facility Residents
POLICY Use of Antipsychotic Medications in Nursing Facility Residents Preamble The Office of Inspector General of the U. S. Department of Health and Human Services issued a report in May 2011 finding that 14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs.1 In addition, 83% of the above Medicare claims for atypical antipsychotics for these elderly nursing home residents were for off---label indications. In 2005, the U. S. Food and Drug Administration required manufacturers of atypical antipsychotic medications to include a boxed warning that these antipsychotics may increase the risk of death in elderly persons with psychosis related to dementia. This warning was expanded to all antipsychotic drugs in 2008. The OIG report found that 88% of the use of atypical antipsychotics was in persons for whom this warning is applicable. As part of the report, OIG conducted medical record reviews on 600 elderly nursing facility residents. They found that 22% of the atypical antipsychotic medications were not administered in accordance with standards from the Centers for Medicare & Medicaid Services relating to unnecessary drug use in nursing homes. This controversial report from the OIG has generated concern about the use of antipsychotics in patients with dementia, and also criticism of the report itself.2 ---4 This document will provide additional background on this subject and a position statement from the American Society of Consultant Pharmacists. Background Understanding the findings and implications of the OIG report on use of atypical antipsychotics in nursing home residents requires placing the report findings into a proper context. Shown below are key points to understanding this report. -
Therapeutic Class Overview Fluoroquinolones
Therapeutic Class Overview Fluoroquinolones INTRODUCTION The fluoroquinolones are broad-spectrum antibiotics grouped into generations based on their spectrum of activity (Bolon 2011). ○ First generation agents, which are structurally quinolones rather than fluoroquinolones, possess activity against aerobic gram-negative bacteria but are not effective against aerobic gram-positive bacteria or anaerobes. The first generation agents (eg, nalidixic acid, cinoxacin) are no longer on the market. ○ Second generation agents, the original fluoroquinolones, contain a fluorine atom at position C-6. These agents offer improved coverage against gram-negative bacteria and moderately improved gram-positive coverage. The available second generation fluoroquinolones include ciprofloxacin, levofloxacin, and ofloxacin. Lomefloxacin and norfloxacin are second generation agents which are no longer on the market. ○ Third generation agents achieve greater potency against gram-positive bacteria, particularly pneumococci, and also possess good activity against anaerobes. All 3 of the third generation agents, gatifloxacin, grepafloxacin, and sparfloxacin, were removed from the market due to toxicities. ○ Fourth generation fluoroquinolones have superior coverage against pneumococci and anaerobes. The available agent is moxifloxacin. Trovafloxacin, was removed from the market due to toxicities, and there is a drug shortage of gemifloxacin. ○ The most recently approved fluoroquinolone, delafloxacin, has an even broader spectrum of antibiotic activity and is commonly referred to as a “next generation” fluoroquinolone. The fluoroquinolones have been used to treat a variety of infections including urinary tract infections, sinusitis, lower respiratory tract infections, intra-abdominal infections, infectious diarrhea, skin and skin structure infections, sexually transmitted diseases, and bacterial prostatitis. A few of the agents also have Food and Drug Administration (FDA) approval for inhalational anthrax and plague. -
Traditional Open Drug List
Traditional Open Drug List Drug list — Four Tier Drug Plan Your prescription benefit comes with a drug list, which is also called a formulary. This list is made up of brand-name and generic prescription drugs approved by the U.S. Food & Drug Administration (FDA). Here are a few things to remember about the list: o You and your doctor can use it as a guide to choose drugs that are best for you. Drugs that aren’t on this list may not be covered by your plan and may cost you more out of pocket. o Your coverage has limitations and exclusions, which means there are certain rules about what's covered by your plan and what isn't. To find out more, view your Certificate/Evidence of Coverage or your Summary Plan Description by logging in at anthem.com and go to My Plan ->Benefits-> Plan Documents. o To help you see how the drug list works with your drug benefit, we've included some frequently asked questions (FAQ) about how the list is set up and what to do if a drug you take isn't on it. o This booklet is updated on a quarterly basis. To view the most up-to-date list of drugs for your plan - including drugs that have been added, generic drugs and more - log in at anthem.com and choose Prescription Benefits. If you have questions about your pharmacy benefits, we're here to help. Just call us at the Pharmacy Member Services number on your ID card. 05374MUMENABS Traditional Open Drug List What is a drug list? The drug list, also called a formulary, is a list of prescription medicines your plan covers. -
Identification, Isolation, Synthesis and Characterization of Impurities of Quetiapine Fumarate
ORIGINAL ARTICLES Aurobindo Pharma Ltd. Research Centre1, Bachupally, J. N. T. University2, Kukatpally, Hyderabad, India Identification, isolation, synthesis and characterization of impurities of quetiapine fumarate Ch. Bharathi1, K. J. Prabahar1, Ch. S. Prasad1, M. Srinivasa Rao1, G. N. Trinadhachary1, V. K. Handa1, R. Dandala1, A. Naidu2 Received May 28, 2007, accepted June 18, 2007 Ramesh Dandala, Senior Vice-President, A. P. L. Research centre, 313, Bachupally, Hyderabad 500072, India [email protected] Pharmazie 63: 14–19 (2008) doi: 10.1691/ph.2008.7174 In the process for the preparation of quetiapine fumarate (1), six unknown impurities and one known impurity (intermediate) were identified ranging from 0.05–0.15% by reverse-phase HPLC. These impu- rities were isolated from crude samples using reverse-phase preparative HPLC. Based on the spectral data, the impurities were characterized as 2-[4-dibenzo[b,f ][1,4]thiazepine-11-yl-1-piperazinyl]1-2-etha- nol (impurity I, desethanol quetiapine), 11-[(N-formyl)-1-piperazinyl]-dibenzo[b,f ][1,4]thiazepine (impur- ity II, N-formyl piperazinyl thiazepine), 2-(2-hydroxy ethoxy)ethyl-2-[2-[4-dibenzo[b,f ][1,4]thiazepine-11- piperazinyl-1-carboxylate (impurity III, quetiapine carboxylate), 11-[4-ethyl-1-piperazinyl]dibenzo [b,f ][1,4] thiazepine (impurity IV, ethylpiperazinyl thiazepine), 2-[2-(4-dibenzo[b,f ][1,4]thiazepin-11-yl-1-piperazi- nyl)ethoxy]1-ethyl ethanol [impurity V, ethyl quetiapine), 1,4-bis[dibenzo[b,f ][1,4]thiazepine-11-yl] piper- azine [impurity VI, bis(dibenzo)piperazine]. The known impurity was an intermediate, 11-piperazinyl- dibenzo [b,f ][1,4]thiazepine (piperazinyl thiazepine). -
Anthem Blue Cross Prescription Formulary List
National Drug List Drug list — Three Tier Drug Plan Your prescription benefit comes with a drug list, which is also called a formulary. This list is made up of brand-name and generic prescription drugs approved by the U.S. Food & Drug Administration (FDA). We’re here to help. If you are a current Anthem member with questions about your pharmacy benefits, we're here to help. Just call us at the Member Services number on your ID card. The plan names to which this formulary applies are shown below. Solution PPO 1500/15/20 $5/$15/$50/$65/30% to $250 after deductible Solution PPO 2000/20/20 $5/$20/$30/$50/30% to $250 Solution PPO 2500/25/20 $5/$20/$40/$60/30% to $250 Solution PPO 3500/30/30 $5/$20/$40/$60/30% to $250 Rx ded $150 Solution PPO 4500/30/30 $5/$20/$40/$75/30% to $250 Solution PPO 5500/30/30 $5/$20/$40/$75/30% to $250 Rx ded $250 $5/$15/$25/$45/30% to $250 $5/$20/$50/$65/30% to $250 Rx ded $500 $5/$15/$30/$50/30% to $250 $5/$20/$50/$70/30% to $250 $5/$15/$40/$60/30% to $250 $5/$20/$50/$70/30% to $250 after deductible Here are a few things to remember: o You can view and search our current drug lists when you visit anthem.com/ca/pharmacyinformation. Please note: The formulary is subject to change and all previous versions of the formulary are no longer in effect. -
Central Nervous System 5 Objectives
B978-0-7234-3630-0.00005-4, 00005 Central nervous system 5 Objectives After reading this chapter, you will: ● Understand the functions of the central nervous system and the diseases that can occur ● Know the drug classes used to treat these conditions, their mechanisms of action and adverse effects. Parkinson’s disease is progressive, with continued BASIC CONCEPTS loss of dopaminergic neurons in the substantia nigra correlating with worsening of clinical symptoms. The The central nervous system consists of the brain and the possibility of a neurotoxic cause has been strengthe- spinal cord, which are continuous with one another. ned by the finding that 1-methyl-4-phenyl-1,2,3, The brain is composed of the cerebrum (which consists 6-tetrahydropyridine (MPTP), a chemical contaminant of the frontal, temporal, parietal and occipital lobes), of heroin, causes irreversible damage to the nigrostriatal the diencephalon (which includes the thalamus and dopaminergic pathway. Thus, this damage can lead hypothalamus), the brainstem (which consists of the mid- to the development of symptoms similar to those of brain, pons and medulla oblongata) and the cerebellum. idiopathic Parkinson’s disease. Drugs that block The brain functions to interpret sensory information dopamine receptors can also induce parkinsonism. obtained about the internal and external environments Neuroleptic drugs (p. 000) used in the treatment of TS1 and send messages to effector organs in response to a schizophrenia can produce parkinsonian symptoms as situation. Different parts of the brain are associated an adverse effect. Rare causes of parkinsonism are cere- with specific functions (Fig. 5.1). However, the brain is a bral ischaemia (progressive atherosclerosis or stroke), complex organ and is not yet completely understood. -
Clinical Trial Protocol
Clinical Trial Protocol - Clinical effectiveness of the newer antipsychotic compounds olanzapine, quetiapine and aripiprazole in comparison with low dose conventional antipsychotics (haloperidol and flupentixol) in patients with schizophrenia - NeSSy (Neuroleptic Strategy Study) ------------------------------------------------------------------------------------------------------------------------------------------------------- - Confidential - Confidential - Confidential - Confidential - Clinical Trial Protocol Clinical Effectiveness Of The Newer Antipsychotic Compounds Olanzapine, Quetiapine And Aripiprazole In Comparison With Low Dose Conventional Antipsychotics (Haloperidol And Flupentixol) In Patients With Schizophrenia The Neuroleptic Strategy Study – NeSSy Protocol-ID.: NeSSy_200901 EudraCT Number 2009-010966-47 ---------------------------------------------------------------------------------------------------------------------------------------------------------- Protocol Authors: Prof. Dr. med. Mühlbauer, Dr. med. Bobis Seidenschwanz, Department of Pharmacology, Klinikum Bremen-Mitte; Prof. Dr. rer. nat. Dr. h.c. Timm, Competence Center for Clinical Trials Bremen, Version 04, 05 December 2012 Page 1 of 44 Clinical Trial Protocol - Clinical effectiveness of the newer antipsychotic compounds olanzapine, quetiapine and aripiprazole in comparison with low dose conventional antipsychotics (haloperidol and flupentixol) in patients with schizophrenia - NeSSy (Neuroleptic Strategy Study) ------------------------------------------------------------------------------------------------------------------------------------------------------- -
AVELOX Or Other Quinolones (4, 5.6) AVELOX® Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS----------------------------- These highlights do not include all the information needed to use Known hypersensitivity to AVELOX or other quinolones (4, 5.6) AVELOX® safely and effectively. See full prescribing information for AVELOX. -----------------------WARNINGS AND PRECAUTIONS----------------------- AVELOX® (moxifloxacin hydrochloride) Tablet, film-coated • Increased risk of tendinitis and tendon rupture. This risk is further increased AVELOX® (moxifloxacin hydrochloride) Injection, solution for IV use in older patients usually over 60 years of age, in patients taking Initial U.S. Approval: 1999 corticosteroids, and in patients with kidney, heart or lung transplants. To reduce the development of drug-resistant bacteria and maintain the Discontinue if pain or inflammation in a tendon occurs. (5.1, 8.5) effectiveness of AVELOX and other antibacterial drugs, AVELOX should be • Prolongation of the QT interval and isolated cases of torsade de pointes has used only to treat or prevent infections that are proven or strongly suspected to been reported. Avoid use in patients with known prolongation, hypokalemia, be caused by susceptible bacteria. and with drugs that prolong the QT interval. (5.2, 7.4, 8.5). Use caution in patients with proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia. (5.2) WARNING: • Serious and sometimes fatal hypersensitivity reactions, including Fluoroquinolones, including AVELOX®, are associated with an anaphylactic reactions, may occur after first or subsequent doses. increased risk of tendinitis and tendon rupture in all ages. This risk is Discontinue drug use at first sign of skin rash, jaundice or any other sign of further increased in older patients usually over 60 years of age, in hypersensitivity. -
Depo-Provera Contraceptive Injection Should Not Be Used As a Long
HIGHLIGHTS OF PRESCRIBING INFORMATION • Known hypersensitivity to Depo-Provera CI (medroxyprogesterone These highlights do not include all the information needed to use DEPO- acetate or any of its other ingredients). (4) PROVERA CI safely and effectively. See full prescribing information for • Significant liver disease. (4) DEPO-PROVERA CI. • Undiagnosed vaginal bleeding. (4) DEPO-PROVERA CI (medroxyprogesterone acetate) injectable ------------------------------WARNINGS AND PRECAUTIONS----------------- suspension, for intramuscular use Thromboembolic Disorders: Discontinue Depo-Provera CI in patients who develop thrombosis (5.2) Initial U.S. Approval: 1959 Cancer Risks: Monitor women with breast nodules or a strong family WARNING: LOSS OF BONE MINERAL DENSITY history of breast cancer carefully. (5.3) • Women who use Depo-Provera Contraceptive Injection (Depo- Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Provera CI) may lose significant bone mineral density. Bone loss is Depo-Provera CI becomes pregnant or complains of severe abdominal greater with increasing duration of use and may not be completely pain. (5.4) reversible. (5.1) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical • It is unknown if use of Depo-Provera Contraceptive Injection during treatment. (5.5) adolescence or early adulthood, a critical period of bone accretion, Liver Function: Discontinue Depo-Provera CI if jaundice or will reduce peak bone mass and increase the risk for osteoporotic disturbances of liver function develop (5.6) Carbohydrate Metabolism: Monitor diabetic patients carefully. (5.11) fracture in later life. (5.1) • Depo-Provera Contraceptive Injection should not be used as a long- ----------------------------------ADVERSE REACTIONS--------------------------- term birth control method (i.e., longer than 2 years) unless other Most common adverse reactions (incidence >5%) are: menstrual irregularities birth control methods are considered inadequate. -
NIH Public Access Author Manuscript Expert Opin Drug Saf
NIH Public Access Author Manuscript Expert Opin Drug Saf. Author manuscript; available in PMC 2009 March 1. NIH-PA Author ManuscriptPublished NIH-PA Author Manuscript in final edited NIH-PA Author Manuscript form as: Expert Opin Drug Saf. 2008 March ; 7(2): 181±194. Sudden cardiac death secondary to antidepressant and antipsychotic drugs Serge Sicouri, MD and Charles Antzelevitch, PhD† Masonic Medical Research Laboratory, 2150 Bleecker Street, Utica, NY, USA Abstract A number of antipsychotic and antidepressant drugs are known to increase the risk of ventricular arrhythmias and sudden cardiac death. Based largely on a concern over QT prolongation and the development of life-threatening arrhythmias, a number of antipsychotic drugs have been temporarily or permanently withdrawn from the market or their use restricted. Some antidepressants and antipsychotics have been linked to QT prolongation and the development of Torsade de pointes arrhythmias, whereas others have been associated with a Brugada syndrome phenotype and the development of polymorphic ventricular arrhythmias. This review examines the mechanisms and predisposing factors underlying the development of cardiac arrhythmias, and sudden cardiac death, associated with antidepressant and antipsychotic drugs in clinical use. Keywords antidepressants; antipsychotics; arrhythmias; Brugada syndrome; long QT syndrome; sudden cardiac death 1. Introduction Sudden unexplained death in individuals with mental health problems was first described in 1849 and a link with antipsychotic drugs was postulated over 40 years ago [1,2]. Starting in early 1990, a clear relationship has been established between antipsychotics, prolongation of the QT interval of the electrocardiogram (ECG), an atypical polymorphic tachycardia known as Torsade de pointes (TdP), and sudden cardiac death (SCD). -
Black Box Warnings 2
First Quarter 2014 P&T Update Vol. XI, Issue 1 Formulary Addition/Deletion Special Points of 1. Argatroban - Argatroban is a selective and short-acting direct thrombin inhibitor FDA Interest: approved for the prophylaxis or treatment of thrombosis or venous thromboembolism in patients with heparin-induced thrombocytopenia (HIT), and of coronary artery • P&T Update-Formulary Addition/Deletion thrombosis during percutaneous coronary intervention in patients at risk of HIT. The formulary addition request was submitted by the Pharmacy Department with • Policy and Procedures/ endorsement from Cardiology and Hematology representatives. Floorstock Update Formulary addition – approved • Black Box Warnings 2. Argatroban dosing nomogram – approved • New Guidelines Released by 3. Dinoprostone 0.5mg gel (Prepidil®) – The Obstetrics, Gynecology, and Women’s Health Joint National Committee Department no longer use dinoprostone gel for cervical ripening. The request to (JNC) 8 for High Blood remove dinoprostone from the formulary was approved. Pressure Management in Formulary deletion – approved. Adults 4. Hydroxocobalamin (Cyanokit®) - Hydroxocobalamin is indicated for treating cyanide toxicity. The UH ED department recommended adding hydroxocobalamin to the formulary in place of Cyanide antidote kit. The committee voted to approve the formulary addition of hydroxocobalamin. A mini-FMEA on hydroxocobalamin was also submitted. Formulary addition – approved 5. Cyanide antidote kit (Sodium Nitrate + Amyl Nitrate + Sodium Thiosulfate) - Cyanide antidote kit has been manufacturer discontinued. The committee voted to delete this product from the formulary. Formulary deletion – approved 6. Pertuzumab (Perjeta®) – Pertuzumab is a monoclonal antibody approved by the FDA to use in combination with trastuzumab and docetaxel as first-line therapy for HER2- positive metastatic breast cancer.