Eye doctors say patient safety is at the heart of federal rule for contact lenses

By Taryn Phaneuf | May 18, 2016

WASHINGTON (Legal Newsline) — In April, the Federal Trade Commission announced that it sent letters to 45 prescribers and 10 sellers of contact lenses, warning them that they may be violating the agency’s Contact Lens Rule.

Rules for selling and prescribing contact lenses are designed to balance consumer freedom and safety, eye doctors say.

“Contact lenses are medical devices,” Dr. Thomas Steinemann, an ophthalmologist at MetroHealth Medical Center in Cleveland and a professor at Case Western Reserve University, told Legal Newsline. “On the one hand, you have a right to shop around for a good price on a contact lens but understand that … you're not shopping for clothing or jewelry or something.”

The rule says prescribers must provide the contact lens prescription to patients at the end of a fitting. They can’t force the patient to buy contacts from them, and they can’t charge extra fees for handing over the prescription.

Additionally, contact lens sellers are required to get a valid prescription from a consumer or verify the prescription with the prescriber before selling to that customer. They are barred from selling lenses to someone attempting to use an expired prescription.

A prescriber or seller who violates the rule could be forced to pay up to $16,000 for each violation.

Steinemann — a trained cornea specialist — frequently sees the consequences of ill-fitting contact lenses. He thinks enforcing the federal contract lens rule is important because it’s about safety. With 41 million contact lens wearers in the U.S., there are plenty of opportunities for problems.

Jeffrey Walline, a member of the Board of Directors of the American Academy of Optometry, agreed.

“The Contact Lens Rule is truly meant to protect the patient,” Waline said. “Eye doctors, sellers, and patients all acting responsibility will result in safe, effective vision correction with contact lenses.”

Contacts are fitted to a person’s unique eye shape. They’re designed to sit on the cornea — “a very delicate piece of tissue,” Steinemann said. The right fit means corrected vision and healthy eyes.

“If it doesn't fit, you're going to have problems — things as simple as not seeing as well or the lens won't feel well,” Steinemann said. “In a worst-case scenario, could you end up with something serious like a scratch or a break on the cornea? Yeah, you've made an opening. That's a conduit for invasion into the eye, meaning infection.”

At his practice, Steinemann surveyed requests for prescription verifications his office was getting from sellers. He found a number issues with the process, including requests from people who he’d never seen as a patient. Others attempted to buy contacts using expired prescriptions.

In October, the American Academy of Ophthalmology responded to an FTC call for comments on the Contact Lens Rule. The FTC asked several questions, including whether there's continued need for the rule.

The academy responded with support for keeping the rule for the sake of patient safety. But it voiced concern over the way prescriptions are verified by sellers outside the prescribing office.

Passive verification allows a retailer to fill an order for contacts if it hasn’t heard a response from the physician within eight business hours. The academy thinks the timeframe is too short.

The academy’s response included an assessment of compliance with the rule. It said a provider reported a 59 percent verification error rate in 2004, which is around the time the contact rule was enacted. In more than 10 years, that’s decreased, but it’s remains above 25 percent. Another practice reported a 60 percent error rate in 137 requests between January 2013 and September 2015.

Based on consumer attempts to get contacts without a prescription, the academy noted that it believes people who wear contact lenses “continue to misunderstand the rule and the necessity for a prescription.”

Steinemann said everyone involved has to abide by the rules.

“Contact lenses are medical devices — one of the most successfully worn and safest if they're worn responsibly. You have a right to shop around but you also have a responsibility to use it safely and as directed,” he said. “It’s a two-way street. I’ve got a responsibility to (patients), too,” Steinemann said. “It's a medical responsibility. We take it very seriously.”

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