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Failure to monitor anti-arrhythmia medication

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


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. 


Disposition
This case was settled on behalf of cardiologist and electrophysiologist. 


Risk management considerations
This case involves several concerns from a risk management perspective. First, medication reconciliation did not appear to be consistent. Reviewing and reconciling medications should be completed at each visit, when prescribing new medications and refilling current medication. According to the Centers for Medicare & Medicaid Services (CMS), medication reconciliation is defined as, “[T]he process of identifying the most accurate list of all medications that the patient is taking, including name, dosage, frequency, and route, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider.” 1

If a patient is hospitalized, practices should ask patients to bring any recent hospital discharge paperwork to be reviewed by the follow-up physician. Patients may also be instructed to bring all bottles of medications being taken, so that the treating physician can accurately reconcile the patient’s current medications and update the medical history at each visit.

Further, it is important to document in the patient record when medications are refilled.  Monitoring medications can prevent abuse, help a physician recognize compliance problems, and prevent drug reactions when this information is readily available in the medical record.

The National Institutes of Health (NIH) advises that having protocols in place for refills can assist physicians to quickly and safely determine whether a refill request is appropriate.

As an example, a refill protocol that consists of inclusion criteria (i.e., providing circumstances and conditions to trigger the protocol), and protocol criteria (providing what “yes/no” statements must all be true for the protocol to pass), is recommended. With this example, protocol criteria must all be true for the protocol to pass; a single failed condition will cause the protocol to fail. Physicians and their staff would be able to view these statements when they consider whether to refill a medication or not.2

Patient record documentation should include a thorough medical history. According to the National Committee for Quality Assurance (NCQA), one of six key components of commonly accepted standards for medical record documentation includes that “past medical history (for patients seen three or more times), is easily identified and includes serious accidents, operations and illnesses.”3 Physicians should review and update patient history at each visit, especially if a patient has been hospitalized or had surgery.

In this case, there was an issue with the patient having medication refills that may have been authorized by non-physicians. When prescriptions are refilled by the office staff (with the use of an appropriate delegation protocol), the physician should co-sign each entry in the medical record. This reduces the opportunity for guesswork regarding whether the staff had authorization to refill medications.

An office policy or procedure in place that outlines the specific circumstances wherein prescriptions may be refilled by office staff is recommended. There should also be specific documentation about when a patient must be seen by a physician before a refill is given.

Finally, a physician who designates another individual as an agent to communicate medications verbally, electronically or in writing to a pharmacy on their behalf should check with their state medical and pharmacy boards to ensure compliance. Maintaining a list of designated agents is recommended and may be required in some states, including Texas.4


Sources

  1. Centers for Medicare & Medicaid Services. Eligible Professional Meaningful Use Menu Set Measures. Measure 6 of 9. Last updated: May 2014. Available at https://www.cms.gov/regulations-and-guidance/legislation/ehrincentiveprograms/downloads/7_medication_reconciliation.pdf. Accessed October 22, 2024.
  2. Tokazewski JT, Peifer M, Howell JT III. Leveraging and Improving Refill Protocols at Your Health System. Appl Clin Inform. 2022;13(5):1063-1069. doi: 10.1055/a-1947-2556. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9646402/. Accessed October 22, 2024.
  3. The National Committee for Quality Assurance (NCQA). Guidelines for Medical Record Documentation. Available at https://www.ncqa.org/wp-content/uploads/2018/07/20180110_Guidelines_Medical_Record_Documentation.pdf.
    Accessed October 22, 2024.
  4. Texas Administrative Code. Chapter 291. Pharmacies. Section 291.3. Available at https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=T&app=9&p_dir=F&p_rloc=208164&p_tloc=9958&p_ploc=1&pg=4&p_tac=&ti=22&pt=15&ch=291&rl=33. Accessed November 25, 2024.

Wayne Wenske can be reached at wayne-wenske@tmlt.org.

Jennifer Templin can be reached at jennifer-templin@tmlt.org.