Plaquenil Toxicity

Preventing Plaquenil-induced eye damage is not just about technology – it’s about timing. Modern tools like OCT and visual field testing are only effective when used at the right intervals and in the right patients. That’s why both ophthalmologists and prescribing physicians must follow clearly defined screening timelines set by major medical societies.

Failure to follow these guidelines – either by delaying or omitting screenings – can result in missed diagnoses and permanent vision loss. To ensure safe use of hydroxychloroquine (Plaquenil), two key sets of professional guidelines have established the current standard of care:

The 2016 AAO Recommendations on Screening

The American Academy of Ophthalmology (AAO) published revised guidelines in 2016 after a landmark study revealed that Plaquenil retinopathy was more common than previously thought – especially in long-term users and those dosed above 5.0 mg/kg/day of actual body weight.

These updated AAO guidelines included several critical changes to clinical practice:

1. Baseline Exam Within 1 Year of Starting Hydroxychloroquine

• All patients should receive a comprehensive retinal evaluation within the first 12 months of beginning Plaquenil therapy.
• The goal is to:
  • Document any preexisting retinal or macular disease that could interfere with future screening
  • Establish a baseline for comparison with future imaging tests
• OCT and visual fields are optional at baseline unless the retina appears abnormal, but they can be useful for patients with other complicating conditions.

2. Annual Screening Begins at Year 5 of Use

• If no major risk factors are present, patients may defer annual screening until after 5 years of continuous therapy.
• However, once the 5-year threshold is crossed, screening must occur annually using at least two sensitive tests (e.g., SD-OCT and visual fields).
• For patients with major risk factors – such as high dosage, renal disease, or concurrent tamoxifen use – annual screening should begin earlier, even before year five.

These recommendations mark a shift away from subjective or sporadic screening and toward routine, standardized monitoring.

The 2020 Joint Statement: Multi-Specialty Consensus

In 2020, four leading medical organizations jointly issued a position statement to further clarify and unify the standard of care:

• American College of Rheumatology (ACR)
• American Academy of Ophthalmology (AAO)
• American Academy of Dermatology (AAD)
• Rheumatologic Dermatology Society (RDS)

This multi-specialty joint statement reinforced the importance of interdisciplinary responsibility: prescribing doctors and eye care providers must work together to protect patients from vision loss.

Key principles from the joint statement include:

1. Standardized Dosage and Screening Protocols

• At or below 5.0 mg/kg/day of actual body weight is reaffirmed as the safe dosage threshold.
• Screening should begin no later than year 5 of continuous use.
• Baseline testing is essential and should be completed early in therapy (ideally within months, and no later than 1 year).

2. Screening Tools Must Be Sensitive and Specific

• Eye care providers must use modern imaging tools, including SD-OCT and visual fields, not outdated tests like Amsler grids or routine ophthalmoscopy.
• Early detection is critical to allow for discontinuation of the drug before damage reaches the fovea or RPE.

3. Shared Responsibility Between Physicians

• The prescribing provider (e.g., rheumatologist, dermatologist) is responsible for:
  • Dosing the drug correctly
  • Referring patients for timely screening
  • Communicating medical history and risk factors to the eye care team
• The ophthalmologist is responsible for:
  • Performing correct tests using race-appropriate protocols
  • Detecting early signs of toxicity
  • Advising on whether continued Plaquenil use is safe

This joint statement serves to eliminate confusion, establish clear expectations, and reduce missed opportunities for prevention.

Following these protocols is not optional – it is the current medical standard of care. When doctors or eye care providers fail to follow these guidelines and patients develop preventable vision loss, that failure may be considered negligence.