To understand the formulary process from the hospital perspective

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1 Formulary Process Michael A. Militello, Pharm.D. Cleveland Clinic Cleveland Clinic 2011 Goal and Objectives To understand the formulary process from the hospital perspective p To list the various panels or committees that review medications To understand how a medication is requested for formulary review To describe what data are included in the formulary review process To describe the formulary implementation and subsequent follow-up 2 1

2 Formulary Health-System Closed formulary Restrictions Medications administered to: Inpatients Outpatients (e.g., vaccines, biologic infusions) Formulary does not include medications dispensed from owned health-system retail pharmacies 3 Formulary Specialty Panels and Medical Staff P&T Committee NeuroSciences Critical Care/Surgery Cardiovascular Hematology/Oncology Internal Medicine Pediatrics Transplant Medical Staff P&T Committee Local P&T Committee 4 2

3 Specialty Panels and P&T Committee Specialty Panels Medical Staff and clinical i l pharmacy specialists that are experts in medical subspecialty Representatives from across health-system Meet once per quarter Recommendations are sent to Medical Staff P&T Committee Medical Staff P&T Committee Review and make final decision i on recommendations from all Specialty Panels Local P&T Chairs from all healthsystem hospitals and Specialty Panel Chairs, Pharmacy, and Nursing Meet once per quarter 5 P&T Committee / Specialty Panels Co-Chair / Membership Two co-chairs; main campus and community hospital Quorum Majority (>50%) of main campus and majority of community hospital members Absence of quorum: discussion of all agenda items, written summary via with any votes required. Voting 2/3 majority vote and majority of both main campus and community hospital members present. Meeting Logistics TBD by co-chairs and committee members Packets sent in advance of meeting date Audio conference / Go to Meeting availability 6 3

4 Local P&T Committees Decisions from Medical Staff P&T Committee are given to local hospital P&T Committees for implementation Local P&T Committees cannot change any decision made by the Medical Staff P&T Committee Local P&T Committees can be more restrictive if needed Medical Staff P&T Committee: Restricted to Cardiology Local P&T Committee: Restricted to select Cardiologists Appeals process 7 Proposed Appeals Process CCHS Medical Staff P&T decisions would be final Sole appeal process goes directly to the Specialty Panel for reconsideration and recommendation to the CCHS Medical Staff P&T Committee for approval Once the appeal decision is approved by CCHS Medical Staff P&T committee, individual hospitals P&T Committees would be expected to implement 8 4

5 Benefits of System-Wide Formulary Management Standardization CPOE, Standard IV concentrations, Smart Pumps drug libraries, Formulary Improved ability/ efficiency for multiple site physician, nursing, pharmacy and allied health care practitioner practice / staffing Appropriate Utilization System wide utilization initiatives to assure appropriate use Cost Improvement Volume / market share contracting Risk Reduction Reduced potential for medication errors 9 Drug Interactions in Clinical Practice 10 5

6 Introduction Significant drug interactions occur daily in clinical practice Drug interactions can lead to: Hospital admissions Increased length of hospital stay Significant physical harm Drug interactions can also be used to our benefit Augmenting immunosuppresants Am J Health-Syst Pharm 1996;53: Drug Safety 1993;9: Introduction Types and number of interactions are increasing ~ 7% of adverse drug events are related to drug-drug g interactions An increasing number of medications are being withdrawn from the market or addition of black box warnings as a direct result of significant adverse drug events related to drug-drug interactions Terfenidine, astemizole, cisapride Lamotrigine and valproic acid 12 6

7 Classifications Drug-Drug Interactions Pharmacokinetic Alterations in drug levels of one medication by another Amiodarone digoxin levels by 2 3 fold Dronedarone digoxin levels by 2 3 fold Amiodarone warfarin levels and thus INR by at least 25 50% Diltiazem will cyclosporine levels Pharmacodynamic Added clinical effects of one drug when added to another Diltiazem and beta blockers Multiple antihypertensive medications 13 Classification Drug-food interactions Grapefruit juice Atorvastatin, lovastatin, simvastatin, amiodarone, dronedarone, cyclosporine, tacrolimus, many calcium channel blockers, vaptan diuretics and many others. Milk and fluroquinolone antibiotics Vitamine K rich food and warfarin Cranberry and warfarin Drug-disease state interactions Reserpine and depression Bupropion and seizure disorders Spironolactone and chronic kidney disease ACE-I and chronic kidney disease 14 7

8 Cytochrome P450 interactions Cytochrome P450 (CYP) drug interactions are one of the most common drug interactions observed in clinical practice Many drugs are substrates, inhibitors or inducers of individual or multiple isoenzymes 15 Cytochrome P450 Substrates Many medications are substrates for the CYP450 enzyme system A substrate is a drug that binds to the enzyme which is then converted to a more readily excreted compound Inhibition of metabolism of some medications may lead to severe adverse events Inhibition of the enzyme leads to increased levels of substrate Induction of the enzyme leads to decreased levels of the substrate 16 8

9 Substrates Agents which are substrates for one enzyme may inhibit or induce the same enzyme or different enzyme Amiodarone a substrate for CYP450 3A4 and is an inhibitor of the 3A4 and the 2D6 isoenzymes 17 CYP450 Inhibitors Inhibition commonly occurs via competitive binding Competition depends on: Substrate affinity Concentration of substrate Half-life of substrate Inhibition depends on: Half-life of inhibitor Time to steady state of the inhibitor 18 9

10 CYP450 Inducers Induction leads to increased metabolism of substrate Induction is not immediate Once inducer is removed metabolism rates take time to return to baseline 19 CYP3A4 Inhibitors Most abundant isoenzyme Clarithromycin, Erythromycin Metronidazole Azole antifungals Indinavir, Ritonivir, Saquinavir, Nelfinavir Grape fruit juice (in the gut only) Amiodarone (moderate) Fluoxetine, Fluvoxamine, Nefazodone, Sertraline 20 10

11 CYP3A4 Common interacting substrates Depending on the severity of the results of the interaction then avoiding the combination or adjusting the doses will be necessary Simvastatin, lovastatin and atrovastatin Amlodipine, felodipine, isradipine Losartan Quinidine R-warfarin (small degree) Cyclosporine, tacrolimus Bosentan 21 CYP2D6 Genetic polymorphism Extensive metabolizers Poor metabolizers 5-15 % Caucasians 2-5 % African Americans 1% Asians 22 11

12 CYP2D6 Inhibitors Amiodarone, Propafenone, Quinidine Fluoxetine, Paroxetine, Sertraline Ritonivir Haloperidol, Thioridazine 23 CYP2D6 Substrates Codeine Flecainide, Mexiletine, Propafenone Bisoprolol, Labetalol, Metoprolol, Pindolol, Propranolol, Timolol 24 12

13 CYP1A2 Induced by smoking Inhibitors include Cimetidine Erythromycin, clarithromycin Ciprofloxcin, levofloxacin, norfloxacin Fluvoxamine 25 CYP1A2 Substrates Amitriptyline, clomipramine, desimpramine, imipramine Theophylline R-warfarin Haloperidol Diazepam 26 13

14 CYP2C Genetic polymorphism Extensive metabolizers Poor metabolizers 20% of Asians and African Americans 3-5% of Caucasians 27 CYP2C isoenzymes Inhibitors Amiodarone Cimetidine Fluvoxamine Fluconazole, ketoconazole Omeprazole 28 14

15 CYP2C isoenzymes Substrates Losartan Bosentan Phenytoin S-warfarin (more pharmacologically active) 29 Inducers of the CYP450 system Phenytoin (3A4, 2D6, 2C9) Phenobarbital (3A4, 2D6, 2C9) Carbamazepine (3A4, 2D6, 2C9) Rifampin (3A4, 2D6, 2C9) Ritonavir (2D6) Smoking (1A2) Bosentan 30 15

16 Available Resources for Evaluating Drug Interactions Lexicomp Available online MicroMedex Available online Hansten and Horn s Drug Interactions Printed version Handbook of top 100 Facts and Comparison Drug Interactions Printed version 31 Summary Drug-drug, Drug-food, Drug-disease interactions occur on a daily basis Avoiding these interactions are impossible in certain cases Understanding, recognizing and minimizing drug related problems are as important as treating the underlying patient s medical condition(s)

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