Failure to monitor anti-arrhythmia medication

‍by Wayne Wenske, Senior Marketing Strategist, and 
Jennifer Templin, Risk Management Representative

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Presentation and physician action‍‍

‍On June 4, 2012, an electrophysiologist performed a cardiac ablation procedure on a 66-year-old man to treat his persistent atrial fibrillation (AFib). The patient’s history included smoking and working in a paint business that involved exposure to paint fumes, sanding particles, and cleaning solutions. Two years later, the patient was treated with a cardioversion procedure by his cardiologist for chronic AFib.

On February 1, 2017, the electrophysiologist performed a second cardiac ablation on the patient. After that procedure, the physician prescribed an anti-arrhythmia medication, amiodarone, to be taken “for a few months.”

Seventeen months later, during a June 8, 2018, follow-up appointment, the electrophysiologist noted that the patient had taken amiodarone “briefly” in 2017 but was no longer taking any anti-arrhythmia medications and remained in sinus rhythm.

This note was repeated in the patient record during a follow up appointment on October 6, 2018. At this appointment, the patient was instructed to see his cardiologist twice a year, but to return if he had any arrhythmia issues.

On December 10, 2018, the cardiologist performed a third cardioversion, but the procedure was discontinued because a thrombus was discovered. The cardiologist’s encounter notes included that the patient was taking amiodarone daily. The patient was given anticoagulants and instructions for rate control. He was scheduled for either a cardioversion or fourth cardiac ablation on December 31.

The patient did not return until February 7, 2019, when he informed the cardiologist that he was recently hospitalized for a gastrointestinal bleed. The cardiologist again noted that the patient was taking amiodarone.

The cardiologist first documented prescribing or refilling amiodarone on June 4, 2020. His record also included notes that the electrophysiologist prescribed amiodarone on June 8, 2020, and in May 2019.

The cardiologist also documented that the patient returned on June 25, 2020, and the amiodarone prescription was stopped. But amiodarone was retained on the patient’s list of current medications in these same encounter notes.

In August 2020, the patient was hospitalized for pneumonia. An internal medicine physician noted that she suspected the patient had amiodarone-induced toxicity. The patient’s amiodarone was discontinued on September 19, 2020.

In November, the patient returned to the cardiologist with persistent AFib. The cardiologist restarted the amiodarone for “rhythm control” and referred the patient to a pulmonologist for evaluation of shortness of breath.

On November 11, 2020, the pulmonologist noted a possibility of amiodarone toxicity and documented concerns about the patient’s occupational exposure history (sanding and painting); possible reflux-related pneumonitis; and lung toxicity — either immunologic related (rheumatoid related) or amiodarone-related.

The pulmonologist stopped the amiodarone and ordered pulmonary function studies. Results showed that the patient had 50 percent pulmonary function.

On December 9, 2020, the pulmonologist diagnosed the patient with advanced amiodarone toxicity with significant pulmonary fibrosis. 

Allegations

‍A lawsuit was filed against the cardiologist and electrophysiologist alleging negligence for not completing annual pulmonary, thyroid, and vision testing while prescribing amiodarone.

It was further alleged that the physicians failed to properly supervise staff members who authorized amiodarone refills and failed to reconcile the patient’s medications. They claimed these failures led to the patient developing amiodarone-induced pulmonary toxicity.

Legal implications

‍Expert consultants for both the defense and the plaintiff were critical of the defendants for failing to recognize that the patient was taking amiodarone over a long period of time and not ordering appropriate testing. All consultants agreed that it is important for any patient taking amiodarone for extended periods to undergo annual pulmonary function, thyroid function, and vision exams. All pointed out that continued amiodarone use without such testing can lead to pulmonary toxicity.

Yet, neither physician ordered these exams. It was inferred from the records that these physicians were not communicating about the amiodarone that they were each prescribing.

Consultants reviewing this case also criticized support staff who were not reconciling medications at patient appointments or authorizing prescriptions without reviewing the medical records.

One consultant pointed out that the patient records clearly reflected that the patient was taking amiodarone. But important details — such as how long, who prescribed it, and whether any surveillance testing was conducted — were lacking. 

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Disposition

‍This case was settled on behalf of cardiologist and electrophysiologist. 

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‍More on medication errors.