16 CFR Part 456 ; Agency Information Collection Activities: Review; Comment Request Ophthalmic Practice Rule (Eyeglass Rule): FTC Project No. R511996 #00643

Submission Number:
Robert Smith
Initiative Name:
16 CFR Part 456 ; Agency Information Collection Activities: Review; Comment Request Ophthalmic Practice Rule (Eyeglass Rule): FTC Project No. R511996
With regard to prescription release, there are flaws that need to be addressed. These flaws allow for inadvertent and intentional abuse of doctors' orders and pose a threat to the visual health of the patient. 1. Prescription expiration As with any FDA approved drug or device, the prescribing doctor is in the best position to determine how long a glasses or contact lens prescription should be active. His/her decision is based on the historical and expected stability of the patient's prescription. Factors influencing stability include the presence of systemic or ocular disease. 2. Prescription Verification With the proliferation and utilization of on-line purveyors, doctor's offices are receiving an increasing number of calls for prescription verification. These calls are time and resource consuming. While the call may take two minutes, one has to include the time it takes to put other calls on hold or have in- office patients wait while the records are looked up and verified as to accuracy. A typical call can therefore take 5 minutes or more. Add to that the time takes to call the seller back and the total time can be closer to 8 or 9 minutes. Lastly, the 8 hour rule of response. If a practitioner is not able to respond within 8 hours then the seller should inform the patient that his/her doctor has not responded and the patient would then call the doctor. This is analogous to prescription medication protocol. I work with a lot of low income patients whose refractive errors require them to wear contact lenses and/or glasses. But in addition to the refractive error they have comorbidities such as diabetes and hypertension - most are aware of these condition while others find out during an eye examination. Passing a rule that compromises the prescribing authority of their doctor and extends the effective date of their prescription will encourage non-compliance with regularly scheduled ocular health examinations in the short run. Without these yearly examinations the nation's strained health resources will be further stretched as patients' ocular and systemic disease worsens. In many cases a yearly eye examination will alert the patient to the presence or likelihood of worsening eye and/or health disease. In closing, I would like to request that The Agency look into the illegal selling of contact lenses and trial lens kits. These lenses are blatantly sold low income neighborhoods without prescription to anyone with the money to buy them. The kits are clearly marked "Not to be resold" but are in fact sold for an average of $5.00. Clearly these merchants are taking advantage of their clientele while also putting their ocular health at risk. For several years I have written letters and have yet to get a response from the FDA. It's as though the eyes of this population are not important enough to warrant an investigation.