Effectiveness of an Amiodarone Protocol and Management Clinic in Improving Adherence to Amiodarone Monitoring Guidelines

Abstract

To determine whether adherence to suggested monitoring parameters improved as a result of the development and implementation of an amiodarone protocol and management clinic. Adverse effects from amiodarone therapy were also evaluated to ascertain whether the Amiodarone Management Clinic (AMC) better identified adverse events as a result of improved monitoring.Methods: A retrospective review of charts of patients with an active amiodarone prescription was conducted. Patients were identified as enrolled in the AMC (intervention) or as receiving standard medical care (control) by nonpharmacist practitioners. Compliance with recommended monitoring parameters, including the presence of interacting medications and associated drug concentration or international normalized ratio (INR), was assessed for all patients and then compared between groups. Type and frequency of adverse effects were determined for both groups.Results: Two hundred twenty-five charts were reviewed; 154 and 71 patients were assigned to the intervention and control groups, respectively. One hundred one (66%) patients in the intervention group were considered compliant with thyroid function monitoring compared with 26 patients (37%) in the control group (p < 0.0001). One hundred six (69%) and 27 (38%) patients in the intervention and control groups, respectively, were deemed compliant with liver function monitoring (p < 0.0001). Intervention patients taking warfarin were more likely to have blood drawn for INR assessment; however, there was no difference in values between groups. Seventy-six patients had a documented adverse effect from amiodarone, 68 of whom were from the intervention group (p < 0.0001). Conclusions:Many patients receiving amiodarone are not managed according to published guidelines. Implementation of a pharmacist-managed protocol and clinic significantly improved compliance with 2 of the 3 parameters needing continuous monitoring. Although more adverse effects were documented for intervention patients, it is unclear whether the AMC actually improved the event detection rate.

Monitoring the use of amiodarone: compliance with guidelines

“…Our results regarding monitoring are similar to others where depending on the tests chosen, both baseline testing and ongoing monitoring have largely been found to be inadequate, the reasons for these omissions have been discussed above 9,17 . Ongoing surveillance can be improved with dedicated clinics.…”

Adherence to Amiodarone Monitoring Recommendations Before and After Implementation of a Centralized Pharmacy Service

“…These findings are supported by other investigations, including a study by Graham et al, which showed that a centralized pharmacy service was not associated with universally improved adherence to amiodarone monitoring. 11 We also found that hospital admissions or ED visits for amiodarone-related ADEs occurred less often among patients enrolled in the AMS compared to control patients. It is noteworthy that thyroid events accounted for over half the total number of amiodarone-related ADEs.…”

Evaluation of a Pharmacist-Managed Amiodarone Monitoring Program

“…15 The mean (SD) digoxin drug concentration was 0.87 (0.50), and the authors did not report any adverse effects related to digoxin use. The proportion of patients in the present study on concomitant digoxin was within the range reported in the study by Graham et al However, 1% of patients in the pharmacist-managed group and 2% in usual care had elevated digoxin concentrations and were either hospitalized or were seen in the ER.…”

“…In contrast, a study that evaluated the effectiveness of an amiodarone management clinic (AMC) at a Veterans Affairs (VA) medical center found that 66% of patients in the AMC versus 37% in the comparison group were compliant with thyroid function monitoring within a year after initiating amiodarone. 15 They were also more likely to be compliant with liver function monitoring (69% vs. 38%).…”

“…The study by Graham et al (2004) conducted at the VA found that 41% of patients enrolled in their pharmacist-managed AMC and 21% in the control group were on concomitant digoxin therapy. 15 The mean (SD) digoxin drug concentration was 0.87 (0.50), and the authors did not report any adverse effects related to digoxin use.…”