PHARMACOLOGY UPDATE: BOOMER DRUGS

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1 PHARMACOLOGY UPDATE: BOOMER DRUGS Sandra Brownstein, PharmD Evercare Clinical Pharmacy Director West Region Objectives: Review the new drugs that have recently been approved by the FDA Determine the role these new products will have in improving outcomes in aging Develop systems to review new products coming to market and how they may impact geriatric care DISCLOSURE OF COMMERCIAL SUPPORT Sandra Brownstein, PharmD does not have a significant financial interest or other relationship with manufacturer(s) of commercial product(s) and /or provider(s) of commercial services discussed in this presentation. However, she may discuss off label use of intervention, but will inform conference participants if applicable. 1

2 Pharmacology update What do the Boomers have to say Sandra Brownstein, PharmD Evercare Clinical Pharmacy Director West Region November 4-5, 2011 Objectives Review Pharmacotherapy in the elderly and how new medications can either help or hinder quality of life. List new agents and reformulations that have come to market this year and their use in the geriatric population Identify agents with black box warnings and their importance in the geriatric population List products that are going from Brand to Generic and their impact in the market Examine the role of the baby boomers and the medication pipeline Pharmaceuticals in the elderly (baby boomers and their parents) Medications are probably the single most important healthcare technology in preventing illness, disability, and death in the senior population 2

3 Pharmacokinetics Pharmacodynamics and adverse drug events Absorption decreased Distribution decreased Metabolism decreased Excretion decreased Half life extended Efficacy higher or lower? Increased or decreased sensitivity to med End organ response Adverse Drug events Any symptom in an elderly patient should be considered a drug side effect until proven otherwise Higher prevalance Increased severity Polypharmacy/polymorbidity Medication errors/reconciliation Black Box Warning Highest FDA warning for adverse events FDA demands drug company to put these warnings on labels and package inserts to help protect patients Warnings usually due to after market reports and post market studies reveal significant issues may be a precursor to drug withdrawal or change Prompt for litigation 3

4 Black Box Warning examples Acetaminophen hepatotoxicity Nonselective NSAIDS cardiovascular and gastrointestinal risk Metformin Lactic Acidosis Metoclopramide Tardive Dyskinesia Atypical Antipsychotics Increased mortality in elderly patients with dementia related psychosis Warfarin bleeding risk Actos, Avandia Congestive Heart Failure exacerbation Speaking of Avandia Last year September 23 announced significant restriction to use November 18 must use special registry to restrict access No longer available in pharmacies Last resort medication Options Actos (same box warning) Brand to Generic products 2011 Many brands have reached their patent life and will be going generic. Will change the formulary landscape More generics available in each medication class Brands continue to modify to keep patent life 4

5 Brand to Generic Aricept to Donepazil (5,10mg) Lovenox to Enoxaparin Avelox to moxifloxacin Levaquin to levofloxacin Veramyst to Fluticasone nasal spray Vytorin to ezetimibe and simvastatin Arixtra to fondaparinux sodium inj Lunesta to eszopiclone Brand to generic in near future Lipitor (185.00) Zyprexa (>400.00) Lexapro Provigil Plavix (215.00) Singulair (182.00) New novel drugs and the baby boomers More new and innovative chemical structures new hope for treatment. More demanding with healthcare Better physical and emotional state Want to live healthier lives Want to aggressively manage chronic disease Want the best care for their aging parents 5

6 New Drugs to review Cardiac/anticoagulation Pradaxa (Dabagatran) Xarelto (rivaroxaban) Brilinta (ticagrelor) Edarbi (Azilsartan medoxomil) Antiinfectives Teflaro (Ceftaroline fosamil) Dificid (Fidaxomicin) New Drugs to review Antidepressants Viibryd (Vilazodone hcl) COPD Daliresp (roflumilast) Arcapta (indacaterol inhalation powder) Misc Horizant (gabapentin enacarbil) Pradaxa Dabagatran Indication: To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation Works as a thrombin inhibitor (different mechanism to warfarinno vit k issues) No blood test to monitor Fewer interactions with other medications Twice daily dosing special packaging No antidote for bleed Higher risk for bleed over 75 years old Must be compliant to avoid complications Must lower dose to 75mg bid in severe renal impairment 6

7 Xarelto rivaroxaban Indication: to reduce the risk of blood clot, deep vein thrombosis, and pulmonary embolism following knee or hip replacement surgery. Factor Xa inhibitor Oral tablet taken daily Avoid other anticoagulants including plavix Adverse reactions hemorrhage Duration of therapy hip 35 days and knee 12 days Brilinta ticagrelor Indication: to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS) Risk of bleed with use Dosing 90mg bid Decreased efficacy when used with greater than 100mg aspirin therapy Drug interaction with statins may increase statin related event Edarbi azilsartan medoxomil Indication: to treat hypertension in adults More effective at lowering 24 hour blood pressure than other ARB 8 th ARB to come to market Benefit to other products? Most ARBs going generic next 2 years 7

8 Teflaro Ceftaroline fosamil Indication: IV treatment for MRSA and other bacterial skin infections (e.coli, strep pyogenes, kleb pneumo Treatment for Community acquired pneumonia from strep pneumonia, e.coli, Kleb pneumo and Hflu Comparable to rocephin Dosing 600mg over one hour bid C.Diff risk with use Dificid Fidaxomicin Indication: treatment of C.Diff associated Diarrhea Dosing- tablet 200mg bid x10days No systemic absorption Very expensive Viibryd Vilazodone hcl Indication: to treat major depressive disorder in adults Titrate to treatment dose: 10mg x7days then 20mg x7days then 40mg dose daily with food No dosing adjustment in elderly No MAOinhibiors 14 days before starting Avoid other Serotonin products including tramadol Suggest a novel mechanism of action but not detailed. Only 8 week trials for efficacy 8

9 Daliresp roflumilast Indication: To decrease the frequency of flare-ups or worsening of symptoms from severe COPD A new drug class for COPD Pill form 500mcg by mouth daily Not to be used for acute bronchospasm Psychiatric events have been reported along with weight loss while taking. Arcapta Indacaterol inhalation powder Indication: long acting beta adrenergic agonist indicated for once daily maintenance bronchodilator treatment for patients with COPD Not indicated for acute deteriorations of COPD Not indicated for Asthma Inhalation of capsule powder in neohaler Use with caution in those with cardiovascular or convulsive disorders. Horizant gabapentin enacarbil Indication: treatment of moderate to severe primary restless legs syndrome in adults To be taken at 5pm, 600mg extended release tablet (can t crush, split, or cut) Double dose no greater efficacy but increased side effect Causes solmnolence/sedation Not interchangable with gabapentin 9

10 Back to the Boomers Will they change the pipeline of drugs Will we continue to see similar drugs or a new pipeline of novel drugs Will insurance companies and formularies control the marketplace Will black box warnings influence the way medicine is practiced in the future In conclusion There are exciting drugs in the pipeline especially the cancer drugs and specialty drugs for MS, hepatitis C and other chronic conditions In geriatrics we must choose our drug regimen carefully and customize to our patient population Just because something is new does not mean it is better than nonmarketed older agents Medication reconciliation is important consideration when evaluating new medications. If a patient changes medical situation (hospital, nursing home, assisted living and home care) will these new medications work in all settings. Thank you QUESTIONS/COMMENTS Contact: Sandra Brownstein, PharmD

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