David A. Cockrell, O.D. Announced as New Chairman of the Health Care Alliance for Patient Safety
(WASHINGTON) – The Health Care Alliance for Patient Safety (APS) today announced David A. Cockrell, O.D. as its new chairman. Dr. Cockrell, a practicing optometrist in Stillwater, Okla., succeeds Deanna Alexander, O.D., whose term as chairwoman concluded at the end of 2020. A photo of Dr. Cockrell can be found here.
“Under the leadership of inaugural chairwoman Deanna Alexander, O.D., the Health Care Alliance for Patient Safety quickly established itself as the leader in advocating for policy that safeguards the millions of contact lens-wearing patients across the United States,” said David Cockrell, O.D. “I’m eager to begin working on priority initiatives that strengthen the doctor-patient relationship, enhance contact lens prescription verification methods to protect patients and modernize the means by which patients are informed of their rights.”
Dr. Cockrell has a long history of advocating for patient safety. He is a past president of the American Optometric Association, American Board of Optometry, Oklahoma State Board of Optometric Examiners and the Oklahoma Association of Optometric Physicians.
He has been recognized for a lifetime of service and advocacy on behalf of patients by being inducted into the American Optometric Association National Hall of Fame, receiving the Oklahoma Association of Optometric Physicians Distinguished Service Award and being named the Optometrist of the Year by the Oklahoma Association of Optometric Physicians.
Dr. David A. Cockrell and his wife, Cherry Cockrell, O.D., own and operate Cockrell Eyecare Center in Stillwater, Okla., where he is active in the Stillwater Rotary Club, Stillwater Chamber of Commerce, the Stillwater Public Education Foundation and the Stillwater Medical Foundation.
Dr. David Cockrell completed his Bachelor’s degree in Zoology at Oklahoma State University and received his Doctor of Optometry degree from Southern College of Optometry.
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Read morePatient Safety Advocates Applauds Congressional Directive to Delay Implementation of the FTC Contact Lens Rule
(WASHINGTON) – The Health Care Alliance for Patient Safety (APS) today applauded Congress for acting to delay the implementation, effective date and enforcement of the Federal Trade Commission’s (FTC) updated Contact Lens Rule (Rule) until March 31, 2021. The Consolidated Appropriations Act, 2021 – the recently passed omnibus appropriations bill for fiscal year 2021 – allowed the directive included in the House Financial Services and General Government (FSGG) report to stand as the operative language directing the FTC’s treatment of the Rule.
The FSGG report, which can be read here, states:
Contact Lenses.—The Committee is disappointed that the FTC’s final amendments to the Contact Lens Rule do not sufficiently address the patient safety concerns the Committee has repeatedly outlined in report language for the past four years. The rule fails to sufficiently modernize the prescription verification process by eliminating the use of robocalls and imposes new burdensome paperwork requirements on providers and patients. To allow providers sufficient time to implement the necessary changes and to prevent additional interruptions in service due to the coronavirus, the Committee directs the FTC to delay the effective date for the amendments, and to suspend any implementation or enforcement of those amendments, until March 31, 2021.
Dr. Deanna Alexander, OD, Chairwoman of APS stated, “Patient safety advocates from across the country applaud Congress for acting to protect patients by delaying the effective date of the Contact Lens Rule. While we are appreciative of Congress’ work, we resolve to continue fighting for patient safety next year when Congress returns. Along with our supporters in both the House and Senate, the Health Care Alliance for Patient Safety will tirelessly advocate for policy that prevents harmful inaccurate contact lens prescriptions from being shipped to patients and onerous regulations being forced upon local doctors.”
Members of Congress on both sides of the aisle and in both chambers have gone on the record calling for changes to how contact lens prescriptions are verified and how patients are notified of their prescription rights. APS has consistently advocated for these important measures to keep patients safe, including through advocacy with the FTC and Congress. Past actions from Members of Congress include:
June 23, 2020: FTC announces final amendments to the Contact Lens Rule
September 17, 2020: The Contact Lens Rule Modernization Act is introduced to modernize the contact lens prescription verification process and eliminate the burdensome signed acknowledgement form requirement.
Read moreAlcon Joins Health Care Alliance for Patient Safety
The Health Care Alliance for Patient Safety (APS) today announced Alcon, a global leader in eye care, as its newest member. Alcon offers a broad range of eye care products and devices, from a complete line of contact lenses, lens care and ocular health products to intraocular lenses, ophthalmic surgical equipment and related products.
Read morePatient Safety Advocates Applaud the Introduction of the Contact Lens Rule Modernization Act in the U.S. Senate
The Health Care Alliance for Patient Safety (APS) today applauded the introduction of the Contact Lens Rule Modernization Act by Sen. John Boozman (R-AR) in the United States Senate. Specifically, the bill, which is co-sponsored by Sen. Roger Wicker (R-MS), Jim Inhofe (R-OK) and Sen. Rand Paul (R-KY), protects patient eye health by eliminating the use of robocalls to verify contact lens prescriptions. The bill also removes burdensome paperwork requirements for patients and providers, instead giving eye care practices the ability to notify patients of key rights regarding their contact lens prescriptions through methods like in-office signage that have been adopted in California. APS has long advocated for these important changes to the Contact Lens Rule, often with the support of Members of Congress on both sides of the aisle.
Read moreFTC at Odds with Congress by Publishing Contact Lens Rule: Patient Safety Advocates Call for Congressional Action to Prevent Implementation of Flawed Final Rule
The Health Care Alliance for Patient Safety (APS) today released the following statement regarding the Federal Trade Commission’s (FTC) publication of the Contact Lens Rule (Rule) in the Federal Register. The Rule was posted for Public Inspection on Friday, August 14th and published in the Federal Register today.
“Since the Federal Trade Commission released the text of the final Contact Lens Rule in June, both Democratic and Republican lawmakers in both the House and Senate have taken action in an attempt to halt the Rule’s implementation due to concerns that it could lead to adverse health outcomes for patients and overly burden doctors, especially during the ongoing pandemic. The Federal Trade Commission’s publication of the Rule disregards the significant bipartisan, bicameral requests from Congress for the FTC to delay the rule. Therefore, we urge Congress to take action to protect patients from the troubling aspects of this Rule,” said Dr. Deanna Alexander, O.D., Chairwoman of the Health Care Alliance for Patient Safety.
Since the FTC released the final amendments to the Contact Lens Rule in June, significant Congressional action has occurred to prevent the Rule’s implementation, but has not been heeded:
June 23, 2020: FTC final amendments to the Contact Lens Rule
APS works to advance policies that protect patient safety. The organization and its members have been active patient safety advocates throughout the FTC’s Contact Lens Rule process, including submitting written comments and testifying at various workshops. Last year, the organization, with the leadership of Rep. Bobby Rush and Rep. Michael Burgess, M.D., worked to offer bipartisan commonsense legislation, H.R. 3975, to address patient safety concerns associated with passive verification of contact lens prescriptions.
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About APS
The Health Care Alliance for Patient Safety, founded in 2018, advocates for eye health and safety and elevates the doctor-patient relationship – the essential foundation of personal health care decision making. Members of the Alliance for Patient Safety work together to raise awareness and protect public health. Advancing policy and collaboration between leading eye health advocates, vision innovators and trusted voices is essential to elevate patient care.
The Alliance is made up of patient safety advocates, eye doctors, contact lens manufacturers and insurers.
To become a local advocate or to get involved in protecting patient safety, visit www.patientsafetytoday.com.
Patient Safety Advocates Praise House Committee’s Actions to Delay Harmful and Burdensome Contact Lens Rule
The Health Care Alliance for Patient Safety (APS) today applauded the House Committee on Appropriations for acting swiftly to delay the effective date and enforcement of the amendments in the newly finalized Contact Lens Rule (Rule), which the Federal Trade Commission (FTC) released on June 23, 2020.
The Committee report, which accompanies the Financial Services and General Government (FSGG) funding bill, is a sharp Congressional rebuke of the FTC’s work on the Contact Lens Rule. Congress and patient safety advocates have repeatedly called attention to flaws in the Rule.
The FSGG report, which can be read here, states:
Contact Lenses —The Committee is disappointed that the FTC’s final amendments to the Contact Lens Rule do not sufficiently address the patient safety concerns the Committee has repeatedly outlined in report language for the past four years. The rule fails to sufficiently modernize the prescription verification process by eliminating the use of robocalls and imposes new burdensome paperwork requirements on providers and patients. To allow providers sufficient time to implement the necessary changes and to prevent additional interruptions in service due to the coronavirus, the Committee directs the FTC to delay the effective date for the amendments, and to suspend any implementation or enforcement of those amendments, until March 31, 2021.
Dr. Deanna Alexander, OD, Chairwoman of APS stated, “For years, Congress and patient safety advocates have been calling for regulatory policy that both protects patient health and eliminates burdensome paperwork regulations on doctors. The requirement to collect, store and maintain unnecessary paperwork for years would be a burden in normal circumstances, but it’s even more challenging and costly for physicians who are navigating a global pandemic and working harder than ever to protect patients’ health and safety. We thank Congressional leaders who have taken swift action to halt the implementation and enforcement of the cumbersome signed acknowledgment form amendment to the Contact Lens Rule.”
A bipartisan group of lawmakers have also introduced a bill backed by patient safety advocates to modernize the prescription verification process, which the FTC’s Rule failed to address. The proposed Contact Lens Prescription Verification Modernization Act, H.R. 3975, increases patient safety by prohibiting prescription verification made via robocall and instead requiring that online sellers use direct communication – like a live phone call, fax, or e-mail – to confirm prescriptions.
Background
APS has been active advocates for patient safety throughout the process leading to the release of the FTC’s Contact Lens Rule. In 2018, the organization submitted its formal written comment, which included the following:
Signed Acknowledgment Forms
In the FTC’s proposed rule, the Commission proposed to require a signed acknowledgment form of prescription release that would allow the patient to acknowledge receipt of their contact lens prescription. In addition, the prescriber would be required to maintain this acknowledgment form for not less than three (3) years so they may be available for inspection by the FTC.
APS understands that the proposed requirement was in response to a small number of claims that suggest that prescribers were not freely giving patients their contact lens prescription as required under the law. In fact, the FTC itself conceded that “many reports of compliance and noncompliance are anecdotal and robust empirical data is sparse.” It is our belief that the Commission’s purpose for the signed acknowledgment form was to educate consumers of their rights while also subjecting doctors to spot investigations regarding the adherence to the law. APS believes that less intrusive means can be used to educate consumers of their rights to freely receive their prescriptions while also ensuring doctors follow the law.
Signage can inform patients of their rights under the law while at the same time providing a form of communication (e.g. phone number) to report any bad actors. This form of education is less intrusive and less burdensome while arguable more informative than a signed paper acknowledgment. APS urges the Commission to consider signage or other forms of educating consumers of their rights that are less intrusive and less burdensome than a signed acknowledgment form.
Out-of-Date Methods for Passive-Verification
In the proposed rule in December 2016, the FTC took the position that updates to the methods used in the verification process were not needed “because the current regulatory framework sufficiently prohibits the use of expired prescriptions.” APS believes the current advancements in technology allow for the FTC to issue guidance on new acceptable forms of verification, (e.g. emails) and disallow outdated forms of verification, like robocalls. Many of the outdated methods currently used do not constitute “direct communication” as intended by Congress.
APS supports the passive-verification process. However, advancements in technology now allow both sellers and prescribers to keep electronic health records. 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 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.
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Vision Health Safety Advocates Call FTC Ruling Dangerous; Congressmen Bobby Rush and Michael C. Burgess, M.D. vow to continue working to protect patients
Vision Health Safety Advocates Call FTC Ruling Dangerous; Congressmen Bobby Rush and Michael C. Burgess, M.D. vow to continue working to protect patients
The Health Care Alliance for Patient Safety (APS) today raised concerns about the final Federal Trade Commission Contact (FTC) Lens Rule that fails to adequately address the dangerous practice of utilizing computer-generated voice calls to verify contact lens prescriptions and places significant burdens on doctors.
In response, APS, together with Congressman Bobby Rush (D-IL) and Congressman Michael C. Burgess, M.D. (R-Texas), vowed to continue their work to pass the Contact Lens Prescription Verification Modernization Act to protect patients. The bill, H.R. 3975, which is co-sponsored by Congressmen Rush and Burgess, has support from Members of both parties.
“I am admittedly disappointed that the final rule still allows automated recordings for prescription verification,” Congressman Bobby Rush (D-IL) said. “Our bill, the Contact Lens Prescription Verification Modernization Act, would correct this outrageous loophole by prohibiting automated verification calls, a practice that has no place in verifying sensitive medical information.”
“I appreciate the FTC updating its Contact Lens Rule to provide increased flexibility for prescription contact lenses. It is critical for patients to receive the correct prescription when ordering contact lenses. The rule requires prescribers to automatically provide a copy of a patient’s prescription and to verify it when provided to third-party sellers. I am disappointed the rule still allows automated recordings for prescription verification, a practice which has led to patient harm when prescriptions have been misunderstood,” Congressman Michael C. Burgess, M.D. said. “A bill I introduced with Representative Bobby Rush, the Contact Lens Prescription Verification Modernization Act, would fix this and protect consumers. I will continue working to ensure that patients and their doctors continue to be at the center of prescribing and safe use of regulated medical devices”
Unless patients have provided them with a copy of the prescription, online contact lens sellers are required to verify a contact lens prescription with the prescribing doctor before completing the sale of these medical devices. Many sellers use computer-generated voices and calls, like robocalls, to attempt verification.
However, robocalls – which will be allowed to continue under this FTC ruling – are undependable and require significant follow-up by doctors and their staff, as the information these robocalls provide is often incomplete, impossible to understand or related to a person who has never been a patient of the eye doctor receiving the call. If an optometrist’s office is unable to verify the validity of a prescription within eight business hours, a contact lens prescription is automatically considered “verified” and sold, even if it was not the prescribed lens.
APS has long maintained that a safer, more responsible and efficient verification method would be email, a technology that is cost effective and could provide clear, written communication to ensure patients receive their correct prescription for contact lenses—Class II and III medical devices. It is inconceivable why the FTC chose to adopt a rule that favors this type of verbal communication over a more modern and accepted method like email.
The proposed Contact Lens Prescription Verification Modernization Act 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 Federal Trade Commission’s final Contact Lens Rule regarding automated calls is seen as dangerous by eye doctors and patients who know that the continued use of antiquated prescription verification technology means incorrect prescriptions will continue to be sent to patients, which could lead to adverse vision health outcomes,” said Dr. Deanna Alexander, O.D., Chairwoman of the Health Care Alliance for Patient Safety. “APS has been working with Congress to pass legislation to remedy this ill-advised ruling on robocalls from the Federal Trade Commission.
The final rule from the FTC also places significant burdens on vision doctors by requiring them to collect, maintain and store signed paperwork from a patient acknowledging receipt of their contact lenses. Throughout the FTC’s consideration of the proposed rule, APS suggested modern, informative and less intrusive means of communicating with patients. Unfortunately, the FTC failed to heed this guidance, instead choosing an outdated, burdensome technology.
Dr. Alexander, speaking on the additional burdens placed on doctors through signed acknowledgement forms, said, “Requiring doctors to maintain and store signed acknowledgement forms for years means adding more costly, administrative burdens that don’t improve patient care and health outcomes. APS will continue to advocate for more effective means of communications with patients that don’t shift physician offices’ focus away from patient care.”
Background
APS has been active advocates for patient safety throughout the comment period for the Contact Lens Rule. In 2018, the organization submitted its formal written comment, which included the following:
Out-of-Date Methods for Passive-Verification
In the proposed rule in December 2016, the FTC took the position that updates to the methods used in the verification process were not needed “because the current regulatory framework sufficiently prohibits the use of expired prescriptions.” APS believes the current advancements in technology allow for the FTC to issue guidance on new acceptable forms of verification, (e.g. emails) and disallow outdated forms of verification, like robocalls. Many of the outdated methods currently used do not constitute “direct communication” as intended by Congress.
APS supports the passive-verification process. However, advancements in technology now allow both sellers and prescribers to keep electronic health records. 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 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.
Signed Acknowledgment
In the FTC’s proposed rule, the Commission proposed to require a signed acknowledgment form of prescription release that would allow the patient to acknowledge receipt of their contact lens prescription. In addition, the prescriber would be required to maintain this acknowledgement form for not less than three (3) years so they may be available for inspection by the FTC.
APS understands that the proposed requirement was in response to a small number of claims that suggest that prescribers were not freely giving patients their contact lens prescription as required under the law. In fact, the FTC itself conceded that “many reports of compliance and noncompliance are anecdotal and robust empirical data is sparse.” It is our belief that the Commission’s purpose for the signed acknowledgment form was to educate consumers of their rights while also subjecting doctors to spot investigations regarding the adherence to the law. APS believes that less intrusive means can be used to educate consumers of their rights to freely receive their prescriptions while also ensuring doctors follow the law.
Signage can inform patients of their rights under the law while at the same time providing a form of communication (e.g. phone number) to report any bad actors. This form of education is less intrusive and less burdensome while arguable more informative than a signed paper acknowledgment. APS urges the Commission to consider signage or other forms of educating consumers of their rights that are less intrusive and less burdensome than a signed acknowledgment form.
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About the Health Care Alliance for Patient Safety
The Health Care Alliance for Patient Safety, founded in 2018, advocates for eye health and safety and elevates the doctor-patient relationship – the essential foundation of personal health care decision making. Members of the Alliance for Patient Safety work together to raise awareness and protect public health. Advancing policy and collaboration between leading eye health advocates, vision innovators and trusted voices is essential to elevate patient care.
The Alliance is made up of patient safety advocates, eye doctors, contact lens manufacturers and insurers.
To become a local advocate or to get involved in protecting patient safety, visit www.patientsafetytoday.com.
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.
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 moreCongressional 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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