Contact Lenses: Patient Safety

More than 45 million Americans rely on contact lenses – FDA regulated medical devices – for safe and effective vision correction. However, improper use can lead to serious health complications, including infections and other sight-threatening conditions, such as corneal edema, ulcers, and neovascularization. 

In fact, the U.S. Centers for Disease Control and Prevention (CDC) reported that annually there are nearly 1 million emergency room and urgent doctor visits and about $175 million in added health care costs arising from keratitis, an eye infection linked to improper contact lens use.

This is why the doctor-patient relationship is so important. Annual eye exams are important to ensure patients get contact lenses that fit the patients, accurate contact lens prescriptions and instructions for safe use, potentially lowering the risk of misuse and patient harm. After the exam, an eye doctor provides patients with a specific and personalized contact lens prescription.

Equipped with their contact lens prescriptions, patients have the ability to purchase contact lenses from many sources, including their eye doctors and internet retailers.

APS seeks to ensure that every American has the right to safe, effective and affordable contact lenses. Our goal is to help educate federal, state and local agencies and provide them with the information they need to help protect contact lens wearers from unnecessary harm.

Background

The Fairness to Contact Lens Consumers Act (FCLCA) was enacted in 2004. The FCLCA carefully balanced interests to promote competition in the sale of contact lenses and protect the health of eye care patients. At the same time, efforts were made to make sure eye care providers were not excessively burdened and that patients were not impacted by undue cost increases. Since the law’s enactment, competition has expanded and contact lens innovation has prospered.

Under the FCLCA, Congress charged the Federal Trade Commission (FTC) with enforcing key conditions, including making sure that doctors provide patients with a prescription, that sellers verify prescriptions with the doctor and fulfill the prescription as written. These requirements have been adhered to by eye doctors, as evidenced by the fact that less than one half of one percent (0.0003) of the more than 45 million contact lens wearing patients in the United States contacted the FTC in the last five years with a valid complaint regarding contact lens prescription release.

In late 2016, the FTC, as part of a 10-year review process, issued a proposed change to the FCLCA Rule, which, rather than address illegal contact lens sales and outdated forms of prescription verification, mandated that every one of the more than 50,000 eye doctors in the United States obtain, and retain, a signed document indicating that the patient received a copy of their contact lens prescription. The proposed change from the FTC fails to address the issues.

Advocating for Patient Safety

APS believes in fair, safe and open access to contact lenses for patients while preserving the doctor-patient relationship. After 10 years of the Contact Lens rule, there remain too many examples of misleading and deceptive practices that place contact lens wearers in harm’s way – such as certain re-sellers selling contact lenses without consideration for the patient’s prescription.  

APS is focused on:

• Working to update out-of-date regulations to reflect today’s contact lens marketplace and to preserve patient safety;
• Educating regulators and policymakers about the importance of annual eye exams and serving as a resource for those working to improve patient safety;
• Informing and implementing policy improvements that strengthen the doctor-patient relationship, which is the center of personalized health care, all while preserving competition in the marketplace.

Online Eye Tests

Just as the health care system rapidly evolves, telehealth is an integral tool in advancing patient health and strengthening the doctor-patient relationship. With faster and clearer methods to connect, more patients can immediately engage with their doctors and collaborate to improve overall health.

With these benefits, there are also potential issues. While patients need ready access to care, telehealth tools should uphold and support the doctor-patient relationship and the medically-recognized standard of care that preserves patient health. With some ocular telehealth tools and vision test apps, patients can be given a false sense of security and can possibly delay essential, sight-saving treatment of more complex diseases.