Medication Monitoring Missteps Lead to Vision Loss

Description

Insufficient medication monitoring, misread diagnostic studies, and poor team communication led to a patient’s permanent eye damage and impaired vision.

Key Lessons

• Thoughtful monitoring of patient medication packaging/warnings may help prevent professional liability claims that relate to long-term prescription management for chronically ill patients.
• Clearly communicating medication risks with patients is essential to support informed decision-making.
• Establishing clear roles and responsibilities among the care team is paramount to safe care, especially in complex cases involving multiple specialists.

Clinical sequence

This case follows a 33-year-old, petite female patient with a significant medical history of lupus diagnosed during adolescence, being treated with hydroxychloroquine. Her first rheumatologist, who made the initial diagnosis, prescribed 400 mg of hydroxychloroquine.

Throughout the next ten years, the patient had sporadic follow-up with rheumatology, however, she was under the regular care of nephrology and a team of physicians from an eye care clinic. During this period, all treating physicians were aware of and documented the hydroxychloroquine prescription and dosage.

Approximately 14 years after starting hydroxychloroquine, a rheumatologist on the treating team noted the large dose of hydroxychloroquine for the patient’s size and suggested lowering the dosage. Because there was no evidence of retinal toxicity or severe renal disease at the time, the treating team maintained the 400 mg dose.

Around the same time, the ophthalmologist reviewed optical coherence tomography (OCT) results from approximately two years earlier. They interpreted the results as normal and recommended that the patient return in one year. The patient did not return for follow-up for two years.

At that time, the ophthalmologist ordered an additional OCT and incorrectly interpreted the results as normal. The patient continued monthly visits for dry eye and vision difficulties.

Six months later, the treating team ultimately diagnosed retinopathy, permanent eye damage, and changes in the macula, all resulting from confirmed toxicity. The team discontinued hydroxychloroquine, ordered an additional OCT, and referred the patient to a specialist. The patient has permanent eye damage.

Allegation

The patient alleged that the treating team’s improper dosing of hydroxychloroquine led to permanent eye damage and vision loss that will require enduring medical care. The patient also alleged that the team failed to disclose the risks associated with hydroxychloroquine.

Disposition

The case settled in the millions.

Clinical Analysis

While the treating team assigned rheumatology with overall monitoring, nephrology with flare-ups, and ophthalmology with managing retinopathy, the defense experts discovered many flaws in the care provided. Key factors contributing to the case included:

• Improper monitoring of patient medication regimen: defense experts indicated that the hydroxychloroquine dosages throughout the patient’s care exceeded those recommended both by the manufacturer and the literature.
• Misinterpretation of diagnostic studies: Defense experts also noted that the first and second OCT results were abnormal and that the treating team should have referred the patient for in-depth testing.
• Providers’ failure to establish clear lines of responsibility resulted in significantly delayed recognition of Hydroxychloroquine toxicity.

Discussion Questions

• How might clearly defined roles and responsibilities for medication monitoring and patient communication have improved the management of long-term risks associated with hydroxychloroquine?
• How might artificial intelligence augment the systems and processes associated with monitoring the administration of high-risk medications?