Monitoring amiodarone's toxicities: recommendations, evidence, and clinical practice

Stelfox, Henry T.; Ahmed, Sofia B.; Fiskio, Julie M.; Bates, David W.

doi:10.1016/j.clpt.2003.09.010

Cited by 59 publications

(58 citation statements)

References 87 publications

(235 reference statements)

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“…7,17,19 These small studies all determined that thyroid function and liver enzymes were monitored in low percentages (23%-42%) of patients. 7,17,19 The current study was therefore undertaken to determine the rates of monitoring thyroid function and liver aminotransferases among ambulatory patients dispensed amiodarone therapy across 10 sites. Secondary objectives included determining the accuracy of administrative claims data for aminotransferase and thyroid function monitoring and describing patient factors associated with monitoring.…”

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confidence: 99%

“…The few studies that evaluated liver and thyroid monitoring among patients prescribed amiodarone were conducted at single clinics and/or included fewer than 100 patients. 7,17,19 These small studies all determined that thyroid function and liver enzymes were monitored in low percentages (23%-42%) of patients. 7,17,19 The current study was therefore undertaken to determine the rates of monitoring thyroid function and liver aminotransferases among ambulatory patients dispensed amiodarone therapy across 10 sites.…”

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confidence: 99%

“…[1][2][3][4][5][6][7][8] Asymptomatic elevation of liver enzymes occurs in 5%-24% of patients prescribed amiodarone, symptomatic liver injury occurs in up to 3%, 4,9 and thyroid dysfunction (including both hyper-and hypothyroidism) occurs in 2% to 24%. [10][11][12] Nearly all cases of liver and thyroid function abnormalities associated with amiodarone therapy are reversible with prompt recognition and management.…”

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confidence: 99%

“…Others (see Table 1) recommend obtaining both ALT/AST and thyroid function tests ([total and/or] free thyroxine [T4] and/or thyroid-stimulating hormone [TSH] at specific frequencies; for example, every 3 or 6 months during therapy. [7][8][9][13][14][15][16][17][18] The extent to which monitoring aminotransferases and thyroid function is conducted as a patient safety measure among patients prescribed amiodarone in ambulatory practice is not well known. The few studies that evaluated liver and thyroid monitoring among patients prescribed amiodarone were conducted at single clinics and/or included fewer than 100 patients.…”

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Liver and Thyroid Monitoring in Ambulatory Patients Prescribed Amiodarone in 10 HMOs

Raebel¹,

Carroll²,

Simon³

et al. 2006

JMCP

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he association between amiodarone and liver, thyroid, ocular, cardiac, skin, and pulmonary adverse events has been recognized for more than 20 years. [1][2][3][4][5][6][7][8] Asymptomatic elevation of liver enzymes occurs in 5%-24% of patients prescribed amiodarone, symptomatic liver injury occurs in up to 3%, 4,9 and thyroid dysfunction (including both hyper-and hypothyroidism) occurs in 2% to 24%. [10][11][12] Nearly all cases of liver and thyroid function abnormalities associated with amiodarone therapy are reversible with prompt recognition and management. If thyroid dysfunction occurs or if liver enzyme elevations exceed 3 times the upper limit of normal, the amiodarone dosage should be reduced or the drug discon-ABSTRACT BACKGROUND: Amiodarone can cause liver and thyroid toxicity, but little is known about compliance with laboratory tests to evaluate liver and thyroid function among ambulatory patients who are dispensed amiodarone.OBJECTIVES: The primary objective of this study was to identify the proportion of ambulatory patients who had liver aminotransferase and thyroid function tests during amiodarone therapy. Secondary objectives were to (1) describe factors associated with receipt of laboratory tests and (2) determine the accuracy of administrative data for assessing aminotransferase and thyroid function monitoring.METHODS: This retrospective cohort study was conducted at 10 health maintenance organizations (HMOs) for the dates of service from January 1, 1999, through June 30, 2001. Participants included 1,055 patients dispensed amiodarone for at least 180 days within this date range; these patients were not necessarily new starts on amiodarone. Administrative claims data were analyzed to assess the percentage of patients with completed alanine/aspartate aminotransferase and thyroid function tests. Depending on the HMO site, electronic or paper medical records were reviewed to evaluate the validity of administrative claims data. Logistic regression models were used to explore factors associated with receipt of laboratory tests.RESULTS: Both aminotransferase and thyroid function tests were completed in 53.3% of patients within a 210-day follow-up period that included the 180-day period of amiodarone dispensings plus 30 days. Thyroid function, with or without liver function (aminotransferase tests), was assessed in 61.9% of patients, and aminotransferase tests, with or without thyroid function, were assessed in 68.2% of patients. After adjusting for patient characteristics and site, the factor most strongly associated with having both types of laboratory tests evaluated was concomitant therapy with a statin (adjusted odds ratio (OR) 1.55; 95% confidence interval (CI), 1.05-2.29). Other factors associated with having both types of laboratory tests evaluated included the number of outpatient visits in the 6 months before the period of amiodarone dispensings (adjusted OR 1.06; 95% CI, 1.00-1.13 for each additional 5 visits) and living in a neighborhood where a higher median percentage of people had a hig...

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confidence: 99%

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confidence: 99%

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confidence: 99%

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confidence: 99%

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Liver and Thyroid Monitoring in Ambulatory Patients Prescribed Amiodarone in 10 HMOs

Raebel¹,

Carroll²,

Simon³

et al. 2006

JMCP

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“…Despite published consensus statements recommending these monitoring requirements, patients receiving amiodarone may not always be appropriately followed. A recent review suggested about 50% of the patients starting amiodarone received minimum baseline evaluation and less than 25% received the recommended ongoing surveillance [8]. Several studies have also been published describing the need for amiodarone drug monitoring [9,10]; however, no universally accepted and feasible approach is available.…”

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confidence: 99%

Comparison of Amiodarone Compliance Monitoring: Usual Care, Electronic Prescribing Template and Pharmacist-Managed Clinic

Poon¹,

Brenner²,

Brenner³

2014

JPP

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Abstract:Objective: To assess whether adherence to amiodarone monitoring differed pre-and post-amiodarone restriction template and implementation of the pharmacist-managed clinic. Design: This was a retrospective chart review study. Setting: A large, academically-affiliated Veteran Affairs Healthcare System providing primary and tertiary care. Patients: 580 patients were identified as having an active prescription for amiodarone for at least 60 days from January 1, 2009 to August 31, 2013 and receiving primary care at the VAAHS (Veterans Affairs Ann Arbor Healthcare System). Results: Nearly all patients had TSH and LFTs at baseline regardless of study group. Significant associations between baseline rates for CXR, ECG, PFT, and ophthalmologic exams were found, with higher rates in the clinic and template arms compared to usual care. Similar patterns for all monitoring outcome rates were also found for both the 6-and 12-month measures. Conclusions: Patients on amiodarone who are followed by a pharmacist-managed clinic or where a restricted ordering template was used had increased compliance with amiodarone monitoring guidelines compared to usual care. Use of a restricted template may be a reasonable option in place of a pharmacist-managed service.

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Improving Laboratory Monitoring at Initiation of Drug Therapy in Ambulatory Care

Raebel

Lyons²,

Chester³

et al. 2005

Arch Intern Med

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Monitoring amiodarone's toxicities: recommendations, evidence, and clinical practice

Cited by 59 publications

References 87 publications

Liver and Thyroid Monitoring in Ambulatory Patients Prescribed Amiodarone in 10 HMOs

Liver and Thyroid Monitoring in Ambulatory Patients Prescribed Amiodarone in 10 HMOs

Comparison of Amiodarone Compliance Monitoring: Usual Care, Electronic Prescribing Template and Pharmacist-Managed Clinic

Improving Laboratory Monitoring at Initiation of Drug Therapy in Ambulatory Care

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