A 52-year-old man suffered a myocardial infarction in 2012. Cardiologist A performed left cardiac catheterization and stenting. The patient was then followed by Cardiologist B, who worked in the same group as Cardiologist A.
Following the procedures, the patient was started on amiodarone at 200 mg daily following an initial 7-day dosage at 400 mg per day. One year later (2013), the patient’s ejection fraction had improved to 40-45 percent. Cardiologist B continued the amiodarone.
Over the next several months, the patient missed several appointments. When he did come to the clinic, he did not bring his prescriptions and often could not recall what medications he was taking.
During a visit in April 2014, Cardiologist B documented that the patient missed several appointments and had stopped taking his medications two months earlier. Cardiologist B discussed the importance of taking medications with the patient and entered an order to “refill all meds.”
A nurse reviewed the chart and provided prescriptions that included amiodarone 200 mg bid (versus a loading dose of 200 mg bid for one week, then 200 mg once per day thereafter). The patient received regular refills of amiodarone at 200 mg bid over the next year.
The patient returned to Cardiologist B in September and again in March 2015. The patient’s ventricular function had improved, and his ejection fraction was 50 percent. At both visits, he listed his medications by memory and did not mention amiodarone. The patient denied having any cardiovascular symptoms, and Cardiologist B documented that he was doing well.
In July 2015, the patient came to the emergency department (ED) of a local hospital with chest pressure, fever, coughing, vomiting, diarrhea, and body aches for four days. He was admitted with a diagnosis of pneumonia.
The patient’s respiratory distress increased, and he was placed on mechanical ventilation. He was ultimately diagnosed with pulmonary toxicity secondary to long-term use of amiodarone. The patient died one week later.
An autopsy revealed diffuse alveolar damage to the lungs with bronchiolitis obliterans, interstitial pneumonitis, and organizing pneumonia. The pathologist noted: “The history of rapid onset and aggravation of the shortness of breath with subsequent death due to the damage in the lungs is consistent with pulmonary toxicity to amiodarone.”
A lawsuit was filed against Cardiologist B and his group. The allegations were:
- negligence in approving a refill request for amiodarone when the patient did not have cardiac complications and had not been taking the drug;
- prescribing amiodarone at a dangerously high dosage;
- failure to perform serial testing of liver and pulmonary functions, and failure to obtain chest x-rays; and
- wrongful death.
The plaintiff’s cardiology consultant criticized the amiodarone prescription for 200 mg twice per day, especially since the patient’s ejection fraction was 49 percent. Cardiologist B testified that he intended to re-start amiodarone at 200 mg twice per day for seven days and then 200 mg per day thereafter. He agreed that the patient should not have been given 200 mg twice per day, and that the nurse who authorized the prescription did not correctly identify the dosage.
Cardiologists reviewing this case for the defense did not support the care provided by Cardiologist B or the group. In addition to the doubling of the amiodarone dosage, there was a poor effort in monitoring the patient’s prescriptions. In their review, they also found that the patient had not been warned about the risks of pulmonary damage associated with the long-term use of amiodarone.
This case was settled on behalf of the cardiology group.
Risk management considerations
Managing amiodarone therapy requires thorough patient education, monitoring, and follow up. Failure to do so may lead to life-threatening side effects.
While the primary allegation involved a medication error, many other factors made this case difficult to defend. Medications should be reviewed, updated, and documented at each visit to monitor compliance and help prevent adverse drug reactions. The patient was not educated about the potentially serious side effects of amiodarone or told what symptoms would be concerning.
Regarding the medication error, the nursing director for the cardiology group testified that the nurse who authorized the prescriptions breached the standard of care. Specifically, the nurse failed to provide a prescription for the correct dose of amiodarone and authorized refills without confirmation from the patient that he was taking the drug. Having accurate documentation in the patient’s record of all medications is critical to patient care.
The patient missed numerous appointments and, when he did come to the office, failed to give reliable information regarding his prescriptions. Asking the patient to bring current prescription bottles or contacting pharmacies to review prescription data may have been helpful. The lack of engagement in his own care, made following up with this patient even more challenging.