As the FTC seeks additional public comments on the proposed Contact Lens Rule, Congressional intent to protect patient safety remains clear
The Health Care Alliance for Patient Safety (Alliance) this week expressed its support of the House Committee on Appropriations for urging the Federal Trade Commission (FTC) to update the process by which contact lens prescriptions are verified.
The Committee report, which accompanies the Financial Services and General Government (FSGG) funding bill, comes as the FTC is accepting additional public comments on the proposed Contact Lens Rule. Patient safety advocates have repeatedly called attention to flaws in current rules related to prescription verification.
The FSGG report, which can be read here, states:
For several years, Alliance members and patient safety advocates have called for updated verification methods that would ensure patients receive the proper medical devices they were prescribed by their eye care professional.
In 2018, the Alliance submitted comments to the FTC that highlighted the problems with the current prescription verification system. The comments read, in part, “FTC action to modernize its guidance around passive-verification communication while excluding antiquated technology (e.g. robocalls) would provide greater documentation and the possibility of greater oversight in the [prescription] verification process. Greater oversight, understanding and documentation will ultimately create a safer and more efficient environment for contact lens wearers and the verification of their prescriptions through clearer, concise and accurate communication between the prescriber and the seller.”
“The doctor-patient relationship is central to the widespread enjoyment of contact lenses. A key part of that equation is ensuring what was prescribed is ultimately provided, as each contact lens is precisely selected for a patient’s specific vision and health needs,” said Michele Andrews, OD, Senior Director, North American Professional & Academic Affairs, CooperVision. “We are committed to advancing healthy contact lens wear for millions of consumers and encourage the FTC to share in this responsibility by addressing and fixing outmoded verification techniques.”
The Alliance encourages patients to share their stories of how antiquated technology in the prescription verification process has been detrimental to their vision health. To share your story and tell the FTC to protect patient safety, visit www.PatientSafetyToday.com/Share_Your_Story.
Deanna Alexander, OD, Chairwoman of the Alliance, concluded, “For a significant period of time, patient safety advocates, like the members of the Alliance, have shared the potential dangers that could stem from the FTC’s current rules related to contact lens prescription verification. Now, as Congress makes it clear that they believe it’s time for a verification system that protects patients’ vision health, the Alliance is hopeful that the FTC will carefully consider adjustments to the Contact Lens Rule to better safeguard patients.”
Health Care Alliance for Patient Safety: FTC Proposed Contact Lens Rule Recognizes Health and Safety, but Opportunities Remain to Address Prescription Verification Loophole and Illegal Sale of Contact Lenses
The Healthcare Alliance for Patient Safety (Alliance) released the following statement in response to last week’s Federal Trade Commission (FTC) proposed supplemental rulemaking on the 2016 proposed Contact Lens Rule.
Congress charged the FTC with enforcing contact lens prescription verification requirements with the passage of the 2004 Fairness to Contact Lens Consumers Act (FCLCA). However, a lack of enforcement of some patient safety protections and the allowance of robocalls as a permissible form of communication for prescription verification has contributed to a growth in illegal sales, including through the filling of expired or non-existent prescriptions and the filling of prescriptions with devices other than what was prescribed by the doctor which put patients eye health and safety at risk.
The FTC’s proposed rule acknowledges some of the key problems associated with prescription verification via robocalls but does not close the verification loophole. Instead, the proposed rule only requires that automated verification telephone messages are “delivered in a slow and deliberate manner and at a reasonably understandable volume,” and “that prescribers be able to repeat the message.”
The FTC shared its concern about the misuse of the prescription verification process to substitute a different brand or manufacturer of lenses. The Alliance agrees with the FTC that contact lens brands are not interchangeable and that substitution is a growing problem in the market, but the Alliance believes that greater enforcement is necessary to ensure that patients receive the exact lenses prescribed by their doctor.
Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety, said, “The FTC’s proposed rule does recognize important issues with the contact lens market, but it does not fully address patient safety concerns around robocall verification of contact lens prescriptions or the ongoing enforcement of illegal substitution for what the patient’s doctor has prescribed. Re-playable, slow and deliberate messages are not the same thing as accurate and secured verification. We believe there is more work to be done to close the verification loophole and protect patients throughout the verification process.”
More than 45 million Americans rely on contact lenses – U.S. Food and Drug Administration Class II and Class III regulated medical devices – for safe and effective vision correction. Contact lenses are more complex than they appear, having differing shapes, strengths, and water contents. There are no generics. Improper lens usage, which can result from the substitution of lenses not as prescribed by the patient’s doctor, can lead to serious health complications, including infections and other sight-threatening conditions, such as corneal edema, ulcers, and neovascularization.
The Health Care Alliance for Patient Safety has made it a priority to close loopholes within the existing verification process and prevent the substitution of lenses to reduce the risk of preventable vision loss. We will continue to work with the FTC, the Food and Drug Administration, the Centers for Disease Control and Prevention, and Congress to be a strong voice and advocate for patient health and safety.Read more
Health Care Alliance for Patient Safety Members Brief Congressional Offices on Concerns Regarding Robocalls and Substitution of Contact Lenses
Advocates in Washington for AOA Fly-In
(WASHINGTON) – Today, members of the Health Care Alliance for Patient Safety (APS) visited nearly a dozen congressional offices. During these meetings, APS advocates briefed Members of Congress and their staffs on problems that vision care patients face including online sellers’ problematic use of robocalls and the medical dangers and safety threats posed by the substitution of lenses that have not been prescribed to a patient.
From left to right: Dr. Jim DeVleming (AOA), Dr. Dorothy Hitchmoth (AOA), Dr. Deanna Alexander (Chair, Health Care Alliance for Patient Safety), Clay Arnold (CooperVision), Dr. Mike Mayers (Johnson & Johnson Vision)
The 2004 Fairness to Contact Lens Consumers Act requires that all third-party sellers must verify prescriptions with an eye doctor and fill the prescription as written. However, the Federal Trade Commission’s (FTC) Contact Lens Rule allows verification to be done via robocalls. Oftentimes, information relayed in these robocalls is garbled or do not align with a patient’s chart—making it difficult, or even impossible, to correctly identify the patient and proper prescription.
More than 45 million Americans rely on contact lenses – U.S. Food and Drug Administration Class II and Class III regulated medical devices – for safe and effective vision correction. Contact lenses are more complex than they appear, having differing shapes, strengths, and water contents. There are no generics. Substitution of lenses not as prescribed by the patient’s doctor can lead to serious health complications, including infections and other sight-threatening conditions, such as corneal edema, ulcers, and neovascularization.
Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety, said, “Access to contact lenses should be fair and safe for patients while preserving the doctor-patient relationship, just as Congress intended. The Health Care Alliance for Patient Safety is committed to working with lawmakers and regulators to address the FTC Contact Lens Rule verification loophole that puts patients’ eye health and safety at risk.”
From left to right: Dr. Deanna Alexander (Chair, Health Care Alliance for Patient Safety), Dr. Mary Anne Murphy (VSP), Dr. Jeff Sonsino (AOA), Dr. Mike Mayers (Johnson & Johnson Vision), Travis Rush (Sightbox), Dr. Gary Orsborn (CooperVision) & Dr. Dorothy Hitchmoth (AOA)
The Health Care Alliance for Patient Safety has made it a priority to close loopholes within the existing verification process and prevent the dangerous sale of counterfeit lenses and the substitution of lenses to reduce the risk of preventable vision loss.Read more
(WASHINGTON) – The Healthcare Alliance for Patient Safety today held a briefing in Washington, DC, for U.S. Senate policy staff on the medical dangers and safety threats posed by counterfeit contact lenses, which can cause medical conditions that lead to blindness.
A 2017 study conducted by the US Food and Drug Administration, which was published in the Journal of Forensic Sciences, found that 60 percent of counterfeit lenses tested came back positive for microbial contamination, which can cause medical ailments leading to vision loss.
Policy leaders also learned at the briefing that while a significant number of these dangerous, counterfeit contact lenses are sold online from suspect retailers or seized upon being imported, some make it into local novelty stores, as was reported by Popular Science Magazine.
The Health Care Alliance for Patient Safety has made it a priority to prevent the dangerous sale of counterfeit lenses, which can cause vision loss.
Dr. Mike Mayers, director of advocacy at Johnson & Johnson Vision, who sat on the panel to brief policy leaders, commented, “In today’s global marketplace, we are likely to continue to see counterfeit contact lenses become prevalent and sophisticated. We must partner with others, including our government, as a greater force to deter the growing threat of counterfeit. Today’s briefing was a step forward in growing that partnership.”
In addition to Mayers, the panel also included:
- Dr. Malvina Edyelman, Center for Device and Radiological Health, Food & Drug Administration
- Dr. Deanna Alexander, O.D., F.A.A.O., Chairwoman, Health Care Alliance for Patient Safety
- Dr. Chris Wroten, Optometrist, Bond Wroten Eye Clinic
“Counterfeit contact lenses, which can be marketed as a costume accessory or be packaged as a traditional medical device, put health and vision safety in significant danger,” said Dr. Alexander. “The Health Care Alliance for Patient Safety recognizes that the sale of counterfeit medical devices to trusting patients is dangerous, and our coalition is committed to seeking action from lawmakers and regulators to end this practice.”
(ARLINGTON, Va.) – The Healthcare Alliance for Patient Safety (Alliance) today released a statement following yesterday’s announcement from the Federal Trade Commission (FTC) that online retailers were in violation of the FTC’s Contact Lens Rule (Rule), resulting in a $60,000 fine and barring the sites from selling contact lenses in the future.
HollywoodColorContacts.com, WorldColorContacts.com and TopModelContacts.com, and their seller, Lawrence L. Duskin, were charged with providing contact lenses to consumers without obtaining the required prescription, failing to verify the prescription information, and failing to keep the records required by the Rule.
The full statement from the FTC, which was released yesterday, December 6, 2018, can be found here.
In response, Dr. Deanna Alexander, O.D., F.A.A.O., chairwoman of the Alliance, issued the following statement:
“The Alliance commends the Federal Trade Commission for taking action to ban these online retailers who were in clear violation of the Contact Lens Rule and putting patients in serious danger. The Alliance, its members, patients and patient advocates have continually communicated that violations of the Rule occur and steps need to be taken to better protect patients. Today, we applaud the FTC for their attention and action to keep patients safe.”
The Health Care Alliance for Patient Safety recently sponsored an event titled “Evolution of Telehealth: Patient Awareness and Education” on Thursday, September 27, 2018 in Washington, D.C. The event was part of The Hill’s event series and included a bipartisan group of lawmakers, industry professionals and vision and telehealth experts.Read more
(WASHINGTON) – The Health Care Alliance for Patient Safety (Alliance) today held an event titled “Evolution of Telehealth: Patient Awareness and Education” in Washington, DC, in conjunction with The Hill. Speakers and panelists continually advocated for synchronizing modern telehealth practices with a strong doctor-patient relationship – a win-win for patients who would see an
increase in health care access while also fostering better health outcomes.
“A bipartisan group of federal lawmakers, telehealth experts, and vision and health care professionals today made clear that even as technology makes us more connected, a strong doctor-patient relationship remains fundamental to treating existing medial ailments and improve health outcomes,” said Alliance Chairwoman Dr. Deanna Alexander, O.D. “The Alliance believes that increased usage of telemedicine can help increase access to healthcare, but technology must be used prudently and can’t be seen as a replacement for all in-person examinations and care.”
Panelists shared how regular consultation with a doctor is critically important to promoting patient health. In the vision health field, a staggering ninety-four percent of patients reported a change in their prescription since their last visit – meaning without a regular eye exam, the patient would have an incorrect prescription. Eye doctors can also determine over 270 underlying health conditions during an exam – like macular degeneration, diabetes, hypertension and glaucoma – making regular examinations crucial to preventative care.
Meanwhile, ill-advised online vision screenings increase the likelihood of poor-fitting lenses. A wrongly-fitted contact lens can cause blurred vision leading to blindness, open sores on the patient’s eyes, and bacterial and viral infections that could lead to vision loss.
Further, in-person consultations can assist with educating patients on proper vision health practices. The Centers for Disease Prevention and Prevention (CDC) has reported the troubling frequency of dangerous practices related to improper contact lens care, all of which can lead negative health conditions:
- Fifty percent of patients wear contact lenses while sleeping
- Fifty-five percent of patients improperly add contact solution to their cases, instead of emptying the case and using new, clean solution
- Eighty-two percent of patients keep their contact lens cases longer than recommended
Event speakers included Congressman Buddy Carter (R-GA), Senator Bill Cassidy, M.D. (R-LA), Congresswoman Doris Matsui (D-CA), Mr. Peter Menziuso, President of North America for Johnson & Johnson Vision, and Co-Chair of the Health Care Alliance for Patient Safety, Dr. David Cockrell, Owner of Cockrell Eyecare Center in Stillwater, Okla., Susan Polan, Associate Executive Director, Public Affairs & Advocacy, American Public Health Association, Natasa Sokolovich, Executive Director, Telehealth, University of Pittsburgh and Samantha Zenlea, Senior Regulatory Policy Specialist, National Council on Aging.Read more
Johnson & Johnson Vision Care North America President added to slate of speakers at telehealth event
(ARLINGTON, Va.) - The Health Care Alliance for Patient Safety (Alliance) today announced an additional speaker at their event titled “Evolution of Telehealth: Patient Awareness and Education” on Thursday, September 27, 2018 at 7:30 a.m. at the Washington Court Hotel in Washington, D.C. Mr. Peter Menziuso, President of North America Vision Care for Johnson & Johnson Vision, and Co-Chair of the Alliance, will provide the sponsor’s perspective at the event.
The event is part of The Hill’s event series and is open to the public and members of the press. Those interested in attending can RSVP here. The event is free to attend.
Other event speakers will include a bipartisan group of lawmakers, industry professionals, and vision and telehealth experts. The event will explore how telemedicine is making healthcare more efficient and effective, when in-person services might be more reliable and how to maintain a strong doctor-patient relationship as technology evolves.
A full list of speakers is as follows:
- Congressman Buddy Carter (R-GA)
- Senator Bill Cassidy, M.D. (R-LA)
- Congresswoman Doris Matsui (D-CA)
- Peter Menziuso, President of North America Vision Care for Johnson & Johnson Vision, and Co-Chair of the Health Care Alliance for Patient Safety
- David Cockrell, Owner of Cockrell Eyecare Center in Stillwater, Okla.
- Susan Polan, Associate Executive Director, Public Affairs & Advocacy, American Public Health Association
- Natasa Sokolovich, Executive Director, Telehealth, University of Pittsburgh
- Samantha Zenlea, Senior Regulatory Policy Specialist, National Council on Aging
Event details are as follows:
“Evolution of Telehealth: Patient Awareness and Education”
Thursday, September 27, 2018
Washington Court Hotel Grand Ballroom
525 New Jersey Ave.
Washington, D.C. 20001
The Alliance was founded in 2018 to advocate for patient safety and to protect and defend the doctor-patient relationship – the essential foundation of personalized health care decision making. For more information, please visit http://www.patientsafetytoday.com/.Read more