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Drug Information Center Highlights of FDA Activities
Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device. -
Attention-Deficit Hyperactivity Disorder (ADHD) Stimulant Step Therapy
Policy: Attention-Deficit Hyperactivity Disorder (ADHD) Annual Review Date: Stimulant Step Therapy Policy 03/18/2021 Last Revised Date: 06/17/2021 OVERVIEW All of the long-acting stimulants are indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). Some products are also indicated for the treatment of narcolepsy. Vyvanse is the only stimulant medication indicated for the treatment of binge eating disorder (BED). Approval for this indication was based on two 12-week randomized, double- blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (n = 374 and n = 350) with moderate to severe BED. Patients from both studies on Vyvanse had a statistically significantly greater reduction from baseline in mean number of binge days/week at Week 12. All of these products have abuse potential and are Schedule II controlled substances. POLICY STATEMENT A step therapy program has been developed to encourage use of one Preferred product prior to the use of a Non-Preferred product. If the step therapy rule is not met for a Non-Preferred agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration. Automation: Patients with a history of one Preferred drug within the 130-day look-back period are excluded from step therapy. Preferred Medications: • Generic amphetamine/dextroamphetamine extended-release capsules (generics to Adderall XR) • Generic dexmethylphenidate extended-release capsules (generics -
PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities &
PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs By: Travis Mickle, PhD INTRODUCTION one or more of the ADME categories — Absorption, Distribution, Metabolism, and Excretion — with the goal being the creation of Attention-deficit/hyperactivity disorder (ADHD) is a neuro- a new chemical entity (NCE) that optimizes the performance, util- logical disorder associated with an ongoing pattern of inattention, ity, and potential life-cycle management of the parent drug. hyperactivity, and/or impulsivity that may impede, for example, cognitive and social functioning, and as well as mental growth and development. Since 1937, more than 25 different products ADHD THERAPEUTIC MARKET have been approved by the FDA to treat ADHD. Despite the many pharmacological advances, there is still no optimal treatment of The Centers for Disease Control and Prevention noted in a this condition, leading prescribers and patients to press for im- 2016 report from the National Survey of Children’s Health that provements that address key shortcomings with currently available 6.1 million, or 9.4% of children aged 4 to 17, suffer from ADHD. ADHD medications. Duration of efficacy, consistency of drug ex- Yet, of all children 2 to 17 years of age that may qualify to take posure and effect, onset of action, and lower abuse potential are ADHD medication, only about 317,000 (or 1 in 20) are currently just some of the key attributes that new technologies are seeking being treated. Globally, there are a reported 175 million cases to address. of ADHD in people 5 to 44 years old, and the forecast indicates In the quest for the optimal ADHD medication, leading re- that this number will rise to more than 185 million by 2025. -
Federal Register/Vol. 86, No. 87/Friday, May 7, 2021/Rules And
Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations 24487 that authority because it addresses an (1) With a switch unit serial number (S/N) Branch, send it to the attention of the person unsafe condition that is likely to exist or 1413, 1414, 1415, 1424, 1428, 1430, 1432, or identified in paragraph (i)(1) of this AD. develop on helicopters identified in this 1433 installed, or Information may be emailed to: 9-AVS-AIR- rulemaking action. (2) With a missing or illegible switch unit [email protected]. S/N or if the S/N cannot be determined, (2) Before using any approved AMOC, Regulatory Findings installed. notify your appropriate principal inspector, Note 1 to paragraph (c): Helicopters with or lacking a principal inspector, the manager This AD will not have federalism a 206L–1+ designation are Model 206L–1 of the local flight standards district office/ implications under Executive Order helicopters. Helicopters with a 206L–3+ certificate holding district office. 13132. This AD will not have a designation are Model 206L–3 helicopters. (i) Related Information substantial direct effect on the States, on Note 2 to paragraph (c): The switch unit the relationship between the national is located on the aft fuel boost pump (1) For more information about this AD, government and the States, or on the assembly. The P/N and S/N for the switch contact Hal Jensen, Aerospace Engineer, unit could be on the outside face of the Operational Safety Branch, FAA, 950 distribution of power and L’Enfant Plaza N SW, Washington, DC 20024; responsibilities among the various attachment flange, in the cross hatched area of the switch unit. -
Psychiatric Medication Update Objectives Abbreviations
3/30/2021 Psychiatric Medication Update Kara Gagnon, PharmD, BCPS, BCPP Pharmacy & Behavioral Health Programs Manager Objectives Identify newly approved psychiatric medications Discuss medications currently in the pipeline Review pertinent FDA MedWatch Alerts Evaluate new treatment guidelines for schizophrenia Abbreviations ADHD: Attention Deficit Hyperactivity Disorder AP: Antipsychotic CNS: Central Nervous System FDA: Food and Drug Administration FGA: First Generation Antipsychotic SGA: Second Generation Antipsychotic VMAT2: Vesicular monoamine transporter 2 1 3/30/2021 FDA Drug Approval Process ✓ Drug developed ✓ Animals tested ✓ Investigational New Drug (IND) application ✓ Phase 1 → Phase 2 → Phase 3 trials ✓ Review meeting: FDA + drug sponsor ✓ New Drug Application ✓ FDA NDA Review ✓ Drug Labeling ✓ Manufacturer facility inspection ✓ Drug Approval ✓ Post-Marketing monitoring Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download FDA Drug Approval Process Faster Approval Options ➢ Accelerated Approval ➢ Fast Track Prescription Drug User Fee Act (1992) FDA MedWatch ➢ Voluntary system for physicians and consumers to report adverse events Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download AzstarysTM (serdexmethylphenidate/dexmethylphenidate) FDA Approval: March 2, 2021 CNS stimulant for treatment of ADHD in patients 6 years of age and older Norepinephrine dopamine reuptake inhibitor; Schedule II substance KemPharm, Inc. ➢ LAT® (Ligand Activated Therapy) technology Azstarys. Package Insert. KemPharm Inc. 2021. 2 3/30/2021 AzstarysTM (serdexmethylphenidate/dexmethylphenidate) Novel once-daily oral capsule ➢ First and only product with dexmethylphenidate prodrug Three strengths available ➢ 26.1mg/5.2mg, 39.2mg/7.8mg, 52.3mg/10.4mg Warnings & Precautions ➢ Abuse/dependence, cardiovascular, psychiatric, growth suppression Azstarys. -
(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 -
Attention Deficit Hyperactivity Disorder Stimulant Medications
Cigna National Formulary Coverage Policy Step Therapy Attention Deficit Hyperactivity Disorder Stimulant Medications Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 14123 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 4 References .......................................................... 5 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. -
Psychotropic Medication Concerns When Treating Individuals with Developmental Disabilities
Tuesday, 2:30 – 4:00, C2 Psychotropic Medication Concerns when Treating Individuals with Developmental Disabilities Richard Berchou 248-613-6716 [email protected] Objective: Identify effective methods for the practical application of concepts related to improving the delivery of services for persons with developmental disabilities Notes: Medication Assistance On-Line Resources OBTAINING MEDICATION: • Needy Meds o Needymeds.com • Partnership for Prescriptions Assistance o Pparx.org • Patient Assistance Program Center o Rxassist.org • Insurance coverage & Prior authorization forms for most drug plans o Covermymeds.com REMINDERS TO TAKE MEDICATION: • Medication reminder by Email, Phone call, or Text message o Sugaredspoon.com ANSWER MOST QUESTIONS ABOUT MEDICATIONS: • Univ. of Michigan/West Virginia Schools of Pharmacy o Justaskblue.com • Interactions between medications, over-the-counter (OTC) products and some foods; also has a pictorial Pill Identifier: May input an entire list of medications o Drugs.com OTHER TRUSTED SITES: • Patient friendly information about disease and diagnoses o Mayoclinic.com, familydoctor.org • Package inserts, boxed warnings, “Dear Doctor” letters (can sign up to receive e- mail alerts) o Dailymed.nlm.nih.gov • Communications about drug safety o www.Fda.gov/cder/drug/drugsafety/drugindex.htm • Purchasing medications on-line o Pharnacychecker.com Updated 2013 Psychotropic Medication for Persons with Developmental Disabilities April 23, 2013 Richard Berchou, Pharm. D. Assoc. Clinical Prof., Dept. Psychiatry & Behavioral -
Clinical Guideline Drug/Drug Class: Antipsychotics Prepared By
MassHealth Drug Utilization Review Program Commonwealth Medicine University of Massachusetts Medical School P.O. Box 2586 Worcester MA, 01613-2586 Clinical Guideline Drug/Drug Class: Antipsychotics Prepared by: Drug Utilization Review Program Prepared for: MassHealth Pharmacy Program Purpose: The purpose of this guideline is to clarify the procedures for approving and denying prior authorization (PA) requests for: Polypharmacy with two or more antipsychotics for members ≥ 18 years old (including first- generation [typical] and second-generation [atypical]) for greater than 60 days (excluding clozapine and injectable formulations) Orally disintegrating dosage forms and Versacloz® (clozapine) oral suspension Medication exceeding defined quantity limits Fanapt® (iloperidone), Invega® (paliperidone), Latuda® (lurasidone), Rexulti® (brexpiprazole), Saphris® (asenapine), and Vraylar® (cariprazine) for members of all ages and all quantities Abilify® (aripiprazole) and Seroquel XR® (quetiapine extended-release) for members 18 years of age and older and all quantities Background: Since 2003, MassHealth has determined that oral second-generation (atypical) antipsychotics (with the exception of clozapine and injectables) would require prior authorization for polypharmacy, defined as two or more second-generation (atypical) antipsychotics for greater than 60 days. Clozapine is excluded from the polypharmacy requirement because the guidelines for the treatment of schizophrenia recognize that combinations including clozapine have been reported. 1 In 2016, the adult antipsychotic polypharmacy criteria was updated and the PA restriction was expanded to include first-generation (typical), and second-generation (atypical) antipsychotics, excluding clozapine and injectable formulations. Orally disintegrating tablets (ODT) of aripiprazole, clozapine, olanzapine and risperidone, as well as Versacloz® (clozapine) oral suspension also require PA since there are more cost-effective alternatives available. -
Psychiatric Medication Update
Psychiatric Medication Update Jeffrey Bowers R.Ph., BCPP Clinical Psychiatric Pharmacist Cox North Hospital Pharmacy Springfield Missouri Objectives Discuss the meaning of New Medication Review new medications Learn to evaluate medications A New Medication for Weight Loss What does that mean? Obesity is now “cured”? For some patients, obesity is “cured”? https://contrave.com/about/ Usual dosage: Two tablets (naltrexone 16 mg/bupropion 180 mg) twice daily Contrave Contrave (bupropion/naltrexone) is a combination product used to promote and maintain weight loss in obese adults or overweight adults who have weight related medical problems. Contrave is the most popular opioid antagonist/atypical antidepressant combinations. There are currently no generic alternatives to Contrave. GoodRx: https://www.goodrx.com/contrave?dosage=8mg-90mg&form=tablet&label_override=Contrave&quantity=120&sort_type=popularity Pharmacology Demystified How does naltrexone work? New Drug? A New Drug Hits The Market The Drug Development Process Step 1: Discovery and Development Step 2: Preclinical Research Step 3: Clinical Research Step 4: FDA Drug Review Step 5: FDA Post-Market Drug Safety Monitoring https://www.fda.gov/patients/drug-development-process/step-5-fda-post-market-drug-safety-monitoring Phase 1 Trial Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Gather information about how a drug interacts with the human body Researchers adjust dosing schemes -
Amoxapine | Memorial Sloan Kettering Cancer Center
PATIENT & CAREGIVER EDUCATION Amoxapine This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. Warning Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur. This drug is not approved for use in children. Talk with the doctor. What is this drug used for? It is used to treat low mood (depression). It may be given to you for other reasons. Talk with the doctor. What do I need to tell my doctor BEFORE I take this drug? If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have had a recent heart attack. If you have taken certain drugs for depression or Parkinson’s disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, Amoxapine 1/7 selegiline, or rasagiline. Very high blood pressure may happen. If you are taking any of these drugs: Linezolid or methylene blue. -
Still the Leading Antidepressant After 40 Years of Randomised Controlle
BRITISH JOURNAL OF PSYCHIATRY "2001), 178, 129^144 REVIEW ARTICLE Amitriptyline vv.therest:stilltheleading METHOD Inclusion criteria antidepressant after 40 years of randomised All RCTs comparing amitriptyline with any y other tricyclic,heterocyclic or SSRI were in- controlled trials cluded. Crossover studies were excluded. Studies adopting any criteria to define CORRADO BARBUI and MATTHEW HOTOPF patients suffering from depression were included; a concurrent diagnosis of another psychiatric disorder was not considered an exclusion criterion. Trials in patients with depression with a concomitant medical ill- Background Tricyclic antidepressants Amitriptyline is one of the first `reference' ness were not included in this review. have similar efficacy and slightly lower tricyclic antidepressants TCAs). Over the past 40 years a number of newer tricyclics, tolerability than selective serotonin Search strategy heterocyclics and selective serotonin re- Relevant studies were located by searching reuptakeinhibitorsreuptake inhibitors SSRIs).However, uptake inhibitors SSRIs) have been intro- the Cochrane Collaboration Depression, there are no systematic reviews assessing duced Garattini et aletal,1998). Despite Anxiety and Neurosis Controlled Trials several large systematic reviews comparing amitriptyline, the reference tricyclic drug, Register CCDANCTR). This specialised tricyclics and SSRIs there is no clear agree- vv. other tricyclics and SSRIs directly. register is regularly updated by electronic ment over first-line treatment of depression Medline,Embase,PsycINFO,LILACS, SongSong et aletal,1993; Anderson & Tomenson, Aims ToreviewTo review the tolerability and Psyndex,CINAHL,SIGLE) and non-electro- 1995; Montgomery & Kasper,1995; efficacy of amitriptyline inthe nicnicliterature searches. The register was HotopfHotopf et aletal,1996; Canadian Coordinating management of depression. searched using the following terms: Office for Health Technology Assessment, AMITRIPTYLIN**AMITRIPTYLIN oror AMITRILAMITRIL oror ELA-ELA- 19971997aa).