Frequency of Adverse Event Monitoring in Ambulatory Patients on Amiodarone or Dofetilide

Rickard, Joshua P; Negrelli, Jenna; Olson, Jeffery L.; Dick, Travis B.

doi:10.1177/0897190017729523

Cited by 5 publications

(6 citation statements)

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“…However, it is associated with a wide variety of side effects that limit its clinical application. Adverse effects include thyroid dysfunction, pulmonary fibrosis, optic neuritis, ataxia, and hepatitis (2–4). Hematologic side effects include bone marrow granulomas, pancytopenia, hemolytic anemia, neutropenia, and thrombocytopenia (5–8).…”

Section: Introductionmentioning

confidence: 99%

Amiodarone-Related Pure Red Cell Aplastic Anemia and Hypothyroidism in a Child With Total Anomalous Pulmonary Venous Connection

Peng

et al. 2019

Front. Pediatr.

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Introduction: Amiodarone is an effective anti-arrhythmic drug, but there are many clinical side effects that limit its application. There are no case reports of amiodarone-related pure red cell aplastic anemia (PRCA).Case Presentation: Here, we present a case of amiodarone-related PRCA and hypothyroidism in a 7-month-old boy. The patient had a total anomalous pulmonary venous connection (the cardiac type) and had undergone cardiac surgery at the age of 2 months. Eleven days after the operation, atrial tachycardia was observed. Amiodarone was administered orally (15 mg/kg.d), following which the arrhythmia was under control. Subsequently, the patient was prescribed amiodarone (5 mg/kg.d) and discharged. Regular medical consultations were not conducted as required. At 7 months of age (5 months after the operation), the patient returned to the hospital for re-examination. The electrocardiogram showed intermittent sinus bradycardia, occasional junctional escape beats, hemoglobin 7.9 g/DL, and thyroid function—TSH 9.660 uIU/mL.Results: Amiodarone was discontinued. Thyroxine was administered orally. Subsequently, the heart rate improved and TSH returned to normal levels. Nutritional therapy was recommended based on a diagnosis of nutrition-related anemia. A re-visit at 9 months of age showed that the weight was 6 kg, but the routine blood test indicated that hemoglobin was 5.9 g/DL with positive cell anemia and low reticulocyte count. Bone marrow cytology examination suggested PRCA. The hemoglobin level was gradually restored after treatment with prednisone.Conclusion: The use of amiodarone in small infants and young children and its side effects should be carefully monitored. The potential mechanism of amiodarone-related PRCA needs further study.

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Section: Introductionmentioning

confidence: 99%

Amiodarone-Related Pure Red Cell Aplastic Anemia and Hypothyroidism in a Child With Total Anomalous Pulmonary Venous Connection

Peng

et al. 2019

Front. Pediatr.

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“…8 -11 Utilizing pharmacists in antiarrhythmic management has been studied as well and been shown to increase adherence and safety while reducing cost of care. 12 -18 However, these studies often focused on outpatient antiarrhythmic management and evaluated one specific monitoring parameter as a primary outcome rather than reviewing their whole antiarrhythmic medication monitoring programs. 12 -18 In previous studies, electrolyte replenishment, patient adherence, or types of pharmacists’ intervention were studied as primary outcomes, but adherence to the institutional policy as a whole was not part of the assessment.…”

Section: Introductionmentioning

confidence: 99%

“…12 -18 However, these studies often focused on outpatient antiarrhythmic management and evaluated one specific monitoring parameter as a primary outcome rather than reviewing their whole antiarrhythmic medication monitoring programs. 12 -18 In previous studies, electrolyte replenishment, patient adherence, or types of pharmacists’ intervention were studied as primary outcomes, but adherence to the institutional policy as a whole was not part of the assessment. 12 -18 In addition, many included multiple antiarrhythmic medications in addition to dofetilide, mainly amiodarone.…”

Section: Introductionmentioning

confidence: 99%

“…12 -18 In previous studies, electrolyte replenishment, patient adherence, or types of pharmacists’ intervention were studied as primary outcomes, but adherence to the institutional policy as a whole was not part of the assessment. 12 -18 In addition, many included multiple antiarrhythmic medications in addition to dofetilide, mainly amiodarone. To our knowledge, there are only 4 reports of pharmacist-managed dofetilide initiation programs in the literature.…”

Section: Introductionmentioning

confidence: 99%

“…To our knowledge, there are only 4 reports of pharmacist-managed dofetilide initiation programs in the literature. 6,12,17,19 Two reports described dofetilide protocols that were created before the removal of the FDA REMS program, which had governed the use of dofetilide until 2016, and none of the studies evaluated adherence to their inpatient protocols or difference in adherence rates after a modification. 6,12,17, 19…”

Section: Introductionmentioning

confidence: 99%

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Pharmacist-Managed Inpatient Dofetilide Initiation Program: Description and Adherence Rate Post-Root Cause Analysis

Carpenter

Gagnon

et al. 2019

Journal of Pharmacy Practice

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The aim of this article is to describe the pharmacist-managed dofetilide initiation program at Maine Medical Center (MMC), assess the adherence rate to 8 core clinical metrics, and review adverse effects before and after a root cause analysis (RCA). Core clinical metrics included pharmacist note entered within 4 hours of dose administration, dose chosen correctly per renal function, QTc measurements obtained and reviewed 2 hours after each dose, appropriate dose adjustment per the most recent QTc measurement, documentation of patient education, and assessment of conduction abnormality, drug–drug interactions, and serum potassium and magnesium concentrations. The primary outcome was adherence rate to all 8 core clinical metrics before and after the RCA. The safety outcome was the total number of adverse events. One hundred patients undergoing elective dofetilide initiation were evaluated: 50 pre-RCA and 50 post-RCA. Adherence rate to all core metrics was 14% in the pre-RCA group and 44% in the post-RCA group ( P < .001). Torsade de pointes occurred 3 times in the pre-RCA group and never in the post-RCA group. After the RCA, adherence to MMC’s pharmacist-managed inpatient dofetilide initiation program significantly improved.

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What methods are being used to create an evidence base on the use of laboratory tests to monitor long-term conditions in primary care? A scoping review

et al. 2020

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Background Studies have shown unwarranted variation in test ordering among GP practices and regions, which may lead to patient harm and increased health care costs. There is currently no robust evidence base to inform guidelines on monitoring long-term conditions. Objectives To map the extent and nature of research that provides evidence on the use of laboratory tests to monitor long-term conditions in primary care, and to identify gaps in existing research. Methods We performed a scoping review—a relatively new approach for mapping research evidence across broad topics—using data abstraction forms and charting data according to a scoping framework. We searched CINAHL, EMBASE and MEDLINE to April 2019. We included studies that aimed to optimize the use of laboratory tests and determine costs, patient harm or variation related to testing in a primary care population with long-term conditions. Results Ninety-four studies were included. Forty percent aimed to describe variation in test ordering and 36% to investigate test performance. Renal function tests (35%), HbA1c (23%) and lipids (17%) were the most studied laboratory tests. Most studies applied a cohort design using routinely collected health care data (49%). We found gaps in research on strategies to optimize test use to improve patient outcomes, optimal testing intervals and patient harms caused by over-testing. Conclusions Future research needs to address these gaps in evidence. High-level evidence is missing, i.e. randomized controlled trials comparing one monitoring strategy to another or quasi-experimental designs such as interrupted time series analysis if trials are not feasible.

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Frequency of Adverse Event Monitoring in Ambulatory Patients on Amiodarone or Dofetilide

Abstract: Amiodarone adverse event monitoring was lower than dofetilide in this cohort. Improving the monitoring of these agents may decrease morbidity risk in this population.

Cited by 5 publications

References 5 publications

Amiodarone-Related Pure Red Cell Aplastic Anemia and Hypothyroidism in a Child With Total Anomalous Pulmonary Venous Connection

Amiodarone-Related Pure Red Cell Aplastic Anemia and Hypothyroidism in a Child With Total Anomalous Pulmonary Venous Connection

Pharmacist-Managed Inpatient Dofetilide Initiation Program: Description and Adherence Rate Post-Root Cause Analysis

What methods are being used to create an evidence base on the use of laboratory tests to monitor long-term conditions in primary care? A scoping review

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