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...