Advocates Urge Georgia Governor to Continue Protecting Patients’ Vision Health Amid Pandemic
Advocates Urge Georgia Governor Brian Kemp to Continue Protecting Patients’ Vision Health Amid Pandemic
Call comes as some groups seek to weaken safety regulations, jeopardizing patients’ vision safety
(Alexandria, Va.) – The Health Care Alliance for Patient Safety (APS) today sent a letter to Georgia Gov. Brian Kemp urging him to protect his constituents’ vision safety by maintaining Georgia’s strong safeguards that ensure vision exams are conducted by doctors and that vision care decisions are made in close consultation between the patient and eyecare provider.
The call from APS comes as certain online contact lens retailers are attempting to use the coronavirus pandemic to loosen essential patient safeguards that are critical to dispensing accurate and safe contact lens prescriptions. Poor-fitting contact lenses or substitutions provided to patients by some online retailers can result in a wide range of visual or ocular harm, including eye pain, vision impairment, corneal neovascularization, keratitis and corneal ulcers.
“Telehealth, which APS supports, is a critical part of our health care system, especially in rural areas. We are proud of optometrists across the country, and in Georgia, for deploying robust telehealth services amid difficult circumstances presented by the pandemic in order to care for their patients and strengthen the doctor-patient relationship,” said Dr. Deanna Alexander, O.D., Chairwoman of the Health Care Alliance for Patient Safety. “Unilaterally removing the doctor from being able to care for their patient, assess potential vision risks and advise on proper corrective vision treatment, as some have suggested to Governor Kemp, would be misguided. We appreciate Georgia’s strong record on protecting patients’ vision safety and respectfully ask Governor Kemp to remain steadfast in his commitment to protecting Georgians vision safety.”
In place of an in-person exam by licensed and trained optometrists, certain online contact lens retailers are actively marketing digital vision assessment applications. Often, these groups use the “results” from these inadequate applications to move patients into contact lenses that they were not prescribed, jeopardizing patient safety. These online retailers also falsely claim that their own brand of lenses are a “generic” version of the patient’s prescribed lens.
What most patients don’t know is that the Food and Drug Administration (FDA) has specifically said that there is “no regulatory pathway for marketing of generic contact lenses. The current clinical care paradigm does not support substitution of contact lens brands without a clinical evaluation.”
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 www.PatientSafetyToday.com.
Advocates issue warnings about vision testing, contact lens refills during COVID-19
May 20, 2020
Healio News - The Health Care Alliance for Patient Safety is calling on the Federal Trade Commission to increase its enforcement of the federal patient safeguards related to contact lens sales in light of the fact that many optometry practices are not fully operational during the COVID-19 pandemic.
Additionally, the American Optometric Association warns the public to be cautious of “at-home eye exam” or “vision test” product claims.
Patient Safety Advocates Call for Immediate Action to Protect Patients’ Vision Health Amid COVID-19 Pandemic
With many doctors of optometry caring for patients via telehealth or working with reduced staff, Alliance for Patient Safety calls for the FTC to require online retailers to seek written electronic prescription verification, enforce federal patient health safeguards related to contact lens sales
(Alexandria, Va.) – On May 11, the Health Care Alliance for Patient Safety (APS) sent a formal letter to the Federal Trade Commission (FTC) asking for immediate action to protect the eye health and safety of contact lens patients across the country amid the coronavirus (COVID-19) pandemic.
While doctors of optometry across the country are continuing to provide essential care for emergency issues, their hours and staff have been significantly reduced to comply with CDC guidance. Recent Jobson Optical Research data shows that over 90 percent of respondents’ practices are in a locality under a stay-at-home order, which means doctors are not in their offices unless there is an emergency issue. The report also shows that up to 60 percent of optometrists have had to let go of staff as a result of the pandemic, and that 44.5 percent of those doctors have had to lay off their entire staff. Combined, these two factors mean that optometry practices are facing challenges in responding to contact lens prescription verification telephone calls, meaning patients could end up receiving contact lenses other than those they were prescribed.
Given the data, APS is calling on the FTC to increase its enforcement of the federal patient health safeguards related to contact lens sales during this time. While APS wants to ensure patients can safely maintain access to contact lenses during this time, APS members are deeply concerned that online contact lens sellers that continue to violate the patient safety standards as written in the Contact Lens Rule and the Fairness to Contact Lens Consumers Act (FCLCA) pose an increased risk to patient safety during the pandemic.
In the letter to the FTC, APS Chair Dr. Deanna Alexander, O.D., said:
“Certain online retailers’ continuing use of antiquated robocall prescription verification is deeply disturbing during this pandemic when doctors are not physically in the office and/or do not have the staff capacity to answer the calls. Even during normal times, these robocalls require significant follow-up by doctors and their staff, as the information they provide is often incomplete, difficult/impossible to understand, or related to a person who has never been a patient of the eye doctor receiving the call. Additionally, they too frequently provide no option to replay the call to confirm the information or a valid call-back number to contact if the information about the prescription is incorrect. If we are to properly ensure patient safety and effectively expand available hospital capacity during the COVID-19 pandemic, we must close regulatory loopholes that allow for the sale of nonprescribed lenses that result in patient harm.”
APS members agree that substituting contact lenses can result in significant injury, including corneal ulcers and impaired or full loss of vision. One common adverse health event related to improper contact lens wear/the use of lenses is keratitis, a painful eye infection that leads to 1 million doctor and hospital visits annually, at a cost of $175 million to the U.S. healthcare system. The APS supports the modernization of the contact lens prescription verification process, which would help ensure patients receive the contact lenses prescribed by their eye care professional, keeping them safer from threats to eye health. APS and will continue to advocate for the use of written verification methods to ensure compliance on all sides.
Read morePatient safety alliance briefs Senate staff on counterfeit contact lenses
January 08, 2019
Healio News - The Health Care Alliance for Patient Safety sponsored a briefing for U.S. Senate Policy Staff on the medical dangers and safety threats posed by counterfeit contact lenses in Washington.
A 2017 study conducted by the FDA found that 60% of counterfeit lenses tested were positive for microbial contamination, according to a press release from the alliance.
Congressional Staff Learn the Dangers of Counterfeit Contact Lenses at Policy Briefing
United States House Staff Learn of Dangers of Counterfeit Contact Lenses at Policy Briefing
Organized by the Health Care Alliance for Patient Safety - bringing together Congressional Staffers, FDA, industry partners, and Optometrists
(WASHINGTON) – The Healthcare Alliance for Patient Safety (APS) convened a panel of experts today on Capitol Hill to brief congressional staff in the House of Representatives on the medical dangers and safety threats posed by counterfeit contact lenses. Following a similar APS presentation for Senate staff in 2018, this panel was a critical step to ensure that Congressional staff at-large are briefed on the dangers of counterfeit lenses—especially since counterfeiting is sometimes overlooked as a major health and safety issue.
The briefing included remarks about the current statistics and dangers of counterfeit lenses in the U.S., FDA and efforts to track and mitigate counterfeit lenses, and policy solutions to prevent counterfeiting from impacting patients. Panelists represented FDA and industry, including:
- Dr. Deanna Alexander, O.D., F.A.A.O., Chairwoman, Health Care Alliance for Patient Safety
- Dr. Malvina Eydelman, Center for Device and Radiological Health, Food & Drug Administration
- Thomas Swinnen, President North America, Johnson & Johnson Vision Care, Inc
- Dr. Gary Orsborn, Vice President Global Professional & Clinical Affairs, CooperVision
- Dr. Bob Theaker, American Optometric Association representative
Staff learned 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.
A 2017 study conducted by the FDA 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 aliments leading to vision loss.
“Ensuring patients are always using a FDA cleared or approved medical device that is authentic and prescribed by their eye care professional is critical when it comes to their eye health and safety and should be taken seriously,” said Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety. “Contact lenses are categorized by the FDA as Class II and Class III medical devices that can pose significant harm to consumers including vision impairment when proper protocols are not followed.”
APS will continue to advocate for efforts to prevent the dangerous sale of counterfeit lenses because they have serious consequences for patient health.
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Senate Subcommittee Urges FTC to Modernize the Contact Lens Verification Process
Senate Subcommittee Urges FTC to Modernize the Contact Lens Verification Process
Latest action from the U.S. Senate means both Chambers have called on the FTC to act in the interest of patient health & safety
(WASHINGTON) – The Health Care Alliance for Patient Safety (Alliance) yesterday applauded the Senate Committee on Appropriations’ urging the Federal Trade Commission (FTC) to update the process by which contact lens prescriptions are verified.
The Committee report, which accompanies the Senate Financial Services and General Government (FSGG) funding bill, comes as the FTC reviews 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 Senate FSGG report, which can be read here, states:
Contact Lenses.—The Committee is encouraged by the FTC’s acknowledgement of certain patient safety concerns in its most recent draft Contact Lens Rule. While the Committee is pleased the FTC has proposed some improvements to previous drafts related to prescription release, electronic delivery, and illegal substitution, the Committee remains concerned that the FTC has not sufficiently addressed the need for the prescription verification process to be modernized to provide for adequate enforcement of the law. Therefore, the Committee urges the FTC to reevaluate its definition of direct communication and consider eliminating the use of automated telephone verification messages, to ensure an effective prescription verification process exists to allow the FTC to properly enforce the rule.
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 July, the Alliance submitted comments to the FTC that highlighted the problems with the current prescription verification system. The comments read, in part, “APS is very concerned with several patient-safety issues regarding automated telephone verification and invalid verification requests that may lead to the alteration of a patient’s contact lens prescription and excessive-quantity sales. Individually, each of these issues pose significant threats to patient eye health. Together, they create an environment where eye health problems have a strong correlation to the disregard for appropriate contact lens care and the implicit de-valuation of a regular eye health exam, which is critical to ensure the safety of contact lens interaction with patients’ eyes.”
Recent action by both the U.S. House FSGG and Senate FSGG demonstrate Congress shares the Alliance’s concerns on how the current contact lens verification process can jeopardize patient safety.
In response to the action taken by Senate FSGG, Deanna Alexander, OD, Chairwoman of the Alliance stated, “Yesterday’s action by the U.S. Senate Appropriations Committee shows that the Alliance’s patient safety advocates are being heard by Members of Congress. We thank the Committee for their work and attention to this important issue. Now, as the FTC continues to review comments on their revised Contact Lens Rule, it’s time for regulators to recognize the need to modernize the way in which prescriptions are verified to ensure patients’ vision health is protected.”
The House Committee on Appropriations FSGG Subcommittee passed similar language in June 2019.
Read moreCooperVision urges FTC to protect patients, competition in Contact Lens Rule
August 20, 2019
Healio News - CooperVision asked the Federal Trade Commission to consider patient safety, the eye care provider’s expertise, stronger enforcement and the use of technology for prescription verification as it evaluates proposed changes to the Contact Lens Rule.
In a letter the company submitted to the Federal Trade Commission (FTC) July 29, CooperVision said, “Fostering competition should not come at the expense of patient safety and excellent lens wearing experiences.”
Burgess offers bipartisan bill to protect America’s consumers of online contact lenses
August 9, 2019
The Ripon Advance - U.S. Rep. Michael Burgess (R-TX) recently introduced bipartisan legislation to protect the nation’s contact lens consumers from unsafe online sales practices.
“In the 21st century marketplace, American patients have more options for buying contact lenses than ever before,” Rep. Burgess said. “It is critical for patients to receive the correct prescription when ordering contact lenses — regardless of where they place the order.”
APS Applauds Introduction of the Contact Lens Prescription Verification Modernization Act
Health Care Alliance for Patient Safety Applauds Introduction of the Contact Lens Prescription Verification Modernization Act
Bipartisan Legislation Introduced in the House by Representatives Rush (IL-1) and Burgess (TX-26)
(WASHINGTON) – The Health Care Alliance for Patient Safety (Alliance) released the following statement in response to today’s introduction of the Contact Lens Prescription Verification Modernization Act (H.R. 3975). The bipartisan legislation introduced by Representative Bobby Rush (D-IL-1) and Representative Michael Burgess (R-TX-26) will help modernize the contact lens prescription verification process and make it simpler and safer for millions of contact lens wearers.
Millions of Americans are able to purchase their contact lenses online thanks to the Fairness to Contact Lens Consumers Act (FCLCA). However, as a patient health safeguard, the law requires online sellers to verify the validity of contact lens prescriptions with the patient’s doctor before fulfilling an order. While the FCLCA clearly allows the use of telephone, fax, or e-mail for verifying prescriptions, the Federal Trade Commission (FTC) has interpreted the law to allow robocall verification, as well.
The use of robocalls to confirm the accuracy of a prescription, which includes several specifications, is far too complicated for an automated phone system. Information relayed in these robocalls is oftentimes garbled or does not align with a patient’s chart—making it difficult, or even impossible, to correctly identify the patient and proper prescription.
“Robocalls should never be used to communicate with a physician’s office regarding patient health and safety matters,” said Barbara L . Horn, OD, President of the American Optometric Association. “With Internet-based mass retailers failing to fix the problem, AOA doctors of optometry are pleased to see Reps. Bobby Rush (D-IL), Michael Burgess, MD (R-TX) and other health policy leaders in Congress joining together on a bi-partisan basis with the Health Care Alliance for Patient Safety to close an outrageous robocall loophole that’s undermining quality care and putting the public at risk.”
H.R. 3975 increases patient safety by prohibiting prescription verification made via robocall and establishing a paper trail by instead requiring that online sellers use direct communication – a live phone call, fax, or e-mail – to confirm prescriptions. The bill also requires online sellers to develop HIPAA-compliant methods for patients to electronically transmit contact lens prescriptions.
Dr. Deanna Alexander, Chairwoman of the Health Care Alliance for Patient Safety, said, “Increasing patients’ choice in the contact lens marketplace should never jeopardize patient safety. The Alliance thanks Congressman Rush and Congressman Burgess for the introduction of this thoughtful legislation that strengthens patient safety and addresses a loophole in the current passive verification system, which often leaves patients at risk of being provided incorrect prescriptions that can lead to adverse health conditions and even vision loss. We will continue to work with Congress to be a strong voice and advocate for patient health and safety.”
On May 2, 2019, the FTC proposed supplemental rulemaking on the 2016 proposed Contact Lens Rule acknowledging some of the key problems associated with prescription verification via robocalls and the misuse of the prescription verification process, which can contribute to substitution of a non-prescribed brand or manufacturer of lenses. However, the proposed supplemental rulemaking does not close the contact lens prescription verification loophole. The Alliance believes congressional action is necessary to ensure that patients receive the exact lenses prescribed by their doctor and increase patient safety. A fact sheet on the Contact Lens Prescription Verification Modernization Act can be found here.
“H.R. 3975 will help ensure prescription validation for millions of contact lens wearers is completed in the most responsible way possible,” said Mary Anne Murphy, OD, and VSP Global board member. “We commend the Health Care Alliance for Patient Safety for its strong leadership on this important legislation which protects patients, while also preserving choice and convenience for them.”
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.
“Addressing shortcomings in outmoded verification techniques is central to ensuring what’s prescribed is actually dispensed. This is essential for optimal vision and ocular health, since doctors select specific contact lenses for individual patient needs,” said Michele Andrews, OD, Senior Director, North American Professional & Academic Affairs, CooperVision. “The Contact Lens Prescription Verification Modernization Act does just that, with the potential to advance healthy contact lens wear for millions of Americans.”
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.
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