03/27/2014. Suzanne M. Lifer: Nothing to disclose Michelle R. Musser: Nothing to disclose

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1 Suzanne Lifer, PharmD Michelle Musser, PharmD, BCPS Authors of this presentation have the following to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: Suzanne M. Lifer: Nothing to disclose Michelle R. Musser: Nothing to disclose Discuss the monitoring parameters and patient education for commonly prescribed anti arrhythmic medications. Discuss the role for pharmacists in the outpatient management of anti arrhythmic medications including roles for clerical staff and pharmacy technicians. Discuss issues related to anti arrhythmic medication management and possible solutions to these issues. Outline the current evidence related to the impact of pharmacist management of anti arrhythmic medications. Class Drugs Ion Block Use Class Ia Quinidine Procainamide Disopyramide Sodium channels (intermediate) Atrial and ventricular arrhythmias Class Ib Lidocaine Mexiletine Sodium channels (fast) Ventricular arrhythmias Adverse effects and Monitoring Class Ic Flecainide Propafenone Sodium channels (slow) Supraventricular arrhythmias and ventricular arrhythmias Class II Beta-blockers Beta receptors Atrial and ventricular arrhythmias Class III Amiodarone Dofetilide Dronedarone Sotalol Ibutilide Potassium channels Atrial and ventricular arrhythmias Class IV Verapamil Diltiazem Calcium channels Atrial and ventricular arrhythmias 1

2 Antiarrhythmic medications play a critical role in the treatment of cardiac arrhythmias. Vaughan Williams Class I antiarrhythmics, such as propafenone, and Class III antiarrhythmics, such as amiodarone, sotalol and dofetilide, are effective yet are associated with significant adverse drug events. It is essential to perform periodic monitoring of laboratory and objective testing to: Prevent any unwanted adverse events. Ensure the safe and effective use of these medications. Standardized monitoring protocols based on established guidelines exist for amiodarone and dofetilide. No formal guidelines exist for monitoring sotalol or propafenone. Am J Health-Syst Pharm. 2012;69: Clin Pharmacol Ther. 2004;75: Intern Med J. 2006;36: Drug Adverse Effects Avoid in: Propafenone (Rhythmol, Rhythmol SR) Amiodarone (Cordarone, Pacerone) Sotalol (Betapace, Betapace AF) Dofetilide (Tikosyn) Metallic taste Dizziness Bradycardia/heart block Bronchospasm Worsening HF Agranulocytosis Pulmonary fibrosis Hypo/hyperthyroidism Photosensitivity Hepatitis Heart block Skin discoloration Corneal deposits TdP (<1%) Bradycardia/heart block Dizziness Wheezing Worsening HF TdP (3-8%) Dizziness Headache TdP (3.3% in HF) HF Post MI Liver disease Sinus bradycardia Electrolyte abnormalities Marked hypotension 2 nd -3 rd degree heart block Iodine hypersensitivity Bradycardia with syncope Baseline QT >450 ms (Afib) CrCl <40 ml/min (Afib) K+ <4 meq/l (Afib) 2 nd -3 rd degree heart block Bradycardia Uncontrolled HF QTc >440 ms CrCl <20 ml/min Drug Dose adjustments Monitoring Propafenone (Rhythmol) Amiodarone (Cordarone, Pacerone) Use caution in renal impairment and hepatic dysfunction Hepatic dysfunction ECG Electrolytes CBC LFT LFT TSH/T4 Electrolytes CXR Ophthalmologic exam PFT ECG Sotalol Renal impairment ECG Electrolytes/SCr *Inpatient initiation Dofetilide (Tikosyn) Renal impairment ECG Electrolytes/SCr *Inpatient initiation *REMS Drug interactions CYP interactions Other medications associated with QTc prolongation Patient education Adverse effects to expect Adverse effects to report Communicate with health care provider regarding medication changes Need for continued monitoring Role of the pharmacist, pharmacy technicians, and clerical staff 2

3 Blanchard Valley Medical Associates (BVMA) in Findlay, OH Private practice 15 physicians 5 clinical pharmacists Physician referrals are primarily for amiodarone and sotalol. Approximately 150 patients enrolled The pharmacist is responsible for: Ordering testing Coordinating monitoring Evaluating results Providing recommendations to the physician Reviewing results with patients at follow-up appointments Recommended monitoring parameters to assess the safety and efficacy of antiarrhythmic medications: Amiodarone Sotalol Dofetilide Propafenone LFTs Chem-8 Chem-8 Chem-8 TFTs Mg +2 Mg +2 Mg +2 EKG EKG EKG EKG PFTs CXR LFTs CBC BVMA pharmacy secretary: Schedules all patients : Laboratory and objective testing Follow-up office visit with pharmacist to review testing Assists with finding testing results Technicians and/or other clerical staff could also complete these tasks Problem: Ordering and scheduling process is time consuming. Possible Strategies for Improvement Solution: Order and schedule all upcoming testing at end of each appointment with pharmacist. Easier to do face-to-face 3

4 Problem: Minimize the amount of patients who only partially complete testing or complete all testing but do not schedule follow-up appointment with a pharmacist to review results. Solution: Coordinate the execution of lab/objective testing and follow-up appointment with a pharmacist. Problem: Difficulty finding/obtaining testing results completed off-site. Solution: Require patients to obtain all testing on-site OR require patients to bring in all copies of testing completed off-site. Problem: Need for more efficient way to follow-up with patients who do not complete testing as scheduled. Solution: Create an electronic tracking system that can be queried monthly to identify patients who have not completed testing. Utilize technology solutions Impact of Pharmacist Management Studies that have examined adherence to recommended monitoring protocols in patients receiving amiodarone: Usual care (management by a physician) is commonly not completed in accordance with recommended guidelines. Pharmacist-managed clinics for monitoring antiarrhythmic medications have provided improved care to patients by: Increasing adherence to monitoring protocols. Increasing identification of adverse events and drug interactions. Intern Med J. 2006;36: J Manag Care Pharm. 2006;12: Pharmacotherapy. 1998;18:146S-151S. Am J Health-Syst Pharm. 2009;66: J Manag Care Pharm. 2011;17(7): Pharmacotherapy. 1998;18(6):146S-151S. 4

5 Trial Primary Outcome Pharmacist Role Conclusion Trial Design Duration N Snider M, Kalbflesich S, Carnes CA. Clin Ther Spence MM, et. al. J Manag Care Pharm Sanoski CA, et. al. Pharmacotherapy chart review cohort study examination with prospective clinical follow-up 9 months years months 60 Snider M, Kalbflesich S, Carnes CA. Clin Ther Spence MM, et. al. J Manag Care Pharm Sanoski CA, et. al. Pharmacotherapy Compliance with protocols at baseline and after enrollment Rates of lab and PFT monitoring compared to usual care for patients on amiodarone Review rationale and development of amiodarone clinic Conducted assessments Interviewed patients Provided education and counseling Ordered tests and procedures Generated testing reminder letters Interviewed patients Screened for drug interactions Provided education Coordinated lab test scheduling Improved patient adherence to recommended testing protocols Helped identify AEs and clinically significant drug interactions Improved monitoring of lab and PFT testing Improvement in adherence after enrollment Improved outcomes by detecting drug related toxicity and facilitating proper dose adjustments Before referral Completion of Testing After Initial Visit 59% of patients 98.5% of patients *Testing had to be completed within 10% of the timeframe in the monitoring protocols Significant improvement seen in patient adherence compared with pre-enrollment: Each recommended test for patients on amiodarone and dofetilide (p<0.05). Only with LFTs for patients on propafenone (p<0.05). No significant improvement in adherence to monitoring protocols for patients on sotalol. Adverse Events Identified Interval ALT TSH T 4 PFT CXR 44% of patients had at least 1 event* Months 1-6 * * * * * 38% of visits Months 7-12 * * * * 77 events Months events required physician contact * * * * 11 events with symptoms requiring physician referral 11 events detected by medication reconciliation 21 clinically significant drug interactions *Monitoring rates significantly higher in the pharmacist-managed group compared to *Event requiring further assessment, intervention, and/or follow-up usual care (p<0.05) Baseline * * * * J Manag Care Pharm. 2011;17(7):

6 Before referral Completion of Testing After enrollment 23% of patients 90% of patients Significant improvement in patient s completing required testing (p<0.001) Previously unrecognized adverse events detected in 21 (35%) patients. Adverse Event Type Number of Patients Increased LFTs 3 Hypo/Hyperthyroidism 8 QTc Prolongation 5 Pulmonary Fibrosis 4 Asthma Exacerbation 1 Dose of amiodarone adjusted in 29 (48%) of patients. Pharmacotherapy. 1998;18:146S-151S. Pharmacotherapy. 1998;18:146S-151S. Trial Primary Outcome Pharmacist Role Conclusion Trial Design Duration N Johnson SG, et. al. J Pharm Pract Tafreshi J, Chui MA, Riley AB. Am J Health-Syst Pharm Snider M, et. al. Am J Health-Syst Pharm , longitudinal cohort study chart review cost analysis 8 years year years 816 Johnson SG, et. al. J Pharm Pract Tafreshi J, Chui MA, Riley AB. Am J Health-Syst Pharm Snider M, et. al. Am J Health-Syst Pharm Adherence to recommended monitoring before and after implementation of a centralized amiodarone monitoring service (AMS) Monitoring completed before and after implementation of amiodarone clinic Cost benefits and savings compared to usual care Initiated TSH/ALT monitoring Ordered CXR/ECG monitoring with physician authorization Audited patient records Analyzed clinical outcomes Recommended testing and dose adjustments Performed medication reviews Evaluated drug interactions Analyzed testing Provided education Improved adherence to ALT and ECG monitoring, but not TSH and CXR monitoring Fewer amiodarone related adverse effects Improved monitoring after implementation of amiodarone clinic which allowed for early detection of adverse events Provision of cost benefits, cost savings, and improved program efficiency Interval ALT ECG CXR TSH Baseline 6 months 12 months * * * * * * *Significantly higher monitoring rates in AMS cohort than control cohort Adverse Event Type AMS Cohort Control Cohort Liver-related 3 9 Thyroid-related Pulmonary-related 3 10 Cardiac-related 0 1 Total (p=0.0362) J Pharm Pract. 2010;23(6): J Pharm Pract. 2010;23(6):

7 Significant improvement in monitoring after referral Few patients had all recommended lab tests performed and no patients had current PFTs prior to referral Previously unrecognized adverse events detected in 23 patients (19%) enrolled Model 1: Clinic visit only Direct costs: $51.77 Mean+SD reimbursement: $ Contribution margin: $0.34 Model 2: Clinic visit+ekg+baseline labs Direct costs: $ Mean+SD reimbursement: $ Contribution margin: $6.32 Am J Health-Syst Pharm. 2009;66: Am J Health-Syst Pharm. 2012;69: Model 3: Model 2 services+pft+cxr Direct costs: $ Mean+SD reimbursement: $ Contribution margin: $ Which of the following is NOT a required component of amiodarone monitoring? a) Liver function b) Renal function c) Thyroid function d) Pulmonary function Am J Health-Syst Pharm. 2012;69: Which of the following is a required component of sotalol monitoring? a) Liver function b) Renal function c) Thyroid function d) Pulmonary function The pharmacist can assist with which of the following tasks in antiarrhythmic management? a) Ordering testing b) Coordinating monitoring c) Evaluating laboratory and objective testing d) Providing recommendations to the physician e) All of the above 7

8 Bickford CL, Spencer AP. Adherence to the NASPE guideline for amiodarone monitoring at a medical university. J Manag Care Pharm. 2006;12: Burgess C, Blaikie A, Ingham T, et al. Monitoring the use of amiodarone: compliance with guidelines. Intern Med J. 2006;36: DiPiro JT, Talbert RL, Matzke GR, Posey LM, Wells BG, Yee GC, et al. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York: McGraw-Hill; Johnson SG, et. al. Adherence to amiodarone monitoring recommendations before and after implementation of a centralized service: a cohort study. J Pharm Pract. 2010;23(6): Sanoski CA, Schoen MD, Gonzalez RC, et al. Rationale, development, and clinical outcomes of a multidisciplinary amiodarone clinic. Pharmacotherapy. 1998;18:146S-151S. Snider M, Carnes C, Grover J, Davis R, Kalbfleisch S. Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring. Am J Health-Syst Pharm. 2012;69: Snider M, Kalbfleisch S, Carnes CA. Initial experience with antiarrhythmic medication monitoring by clinical pharmacists in an outpatient setting: a retrospective review. Clin Ther. 2009;31(6): Spence MM, Polzin JK, Weisberger CL, Martin JP, Rho JP, Willick GH. Evaluation of a pharmacist-managed amiodarone monitoring program. J Manag Care Pharm. 2011;17(7): Stelfox HT, Ahmed SB, Fiskio J, Bates DW. Monitoring amiodarone s toxicities: recommendations, evidence, and clinic practice. Clin Pharmacol Ther. 2004;75: Tafreshi J, Chui MA, Riley AB. Implementation of an amiodarone ambulatory care clinic. Am J Health-Syst Pharm. 2009;66: Suzanne Lifer, PharmD PGY1 Pharmacy Practice Resident Blanchard Valley Medical Associates slifer@bvma.com Michelle Musser, PharmD, BCPS Assistant Professor of Pharmacy Practice Ohio Northern University m-musser@onu.edu 8