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US Senate Policy Staff Briefed on Dangers of Counterfeit Contact Lenses

(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.

Read the full press release here.

 

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FTC Penalizes Online Sellers For Violating Contact Lens Rule

(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.”

Read the full document here

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Patient safety must remain utmost priority as technology evolves

(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 the press release here. 

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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

7:30-9:30 a.m.

Washington Court Hotel Grand Ballroom

525 New Jersey Ave.

Washington, D.C. 20001

For more information on the event, please click here. Members of the press or the general public can RSVP for the event by clicking here.

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/.

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Upcoming Discussion on Telemedicine and the Doctor-Patient Relationship

Free event will be held in Washington, D.C. on September 27th; Event is open to the public, press

 

(ARLINGTON, Va.) - The Health Care Alliance for Patient Safety today announced that it will sponsor an 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. 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.

Speakers, which will include a bipartisan group of lawmakers, industry professionals and vision and telehealth experts, 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.

Speakers will include:

  • Congressman Buddy Carter (R-GA)
  • Senator Bill Cassidy, M.D. (R-LA)
  • Congresswoman Doris Matsui (D-CA)
  • 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
  • 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
7:30-9:30 a.m.
Washington Court Hotel Grand Ballroom
525 New Jersey Ave.
Washington, D.C. 20001


For more information on the event, please click here. Members or the general public can RSVP for the event by clicking here.

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.

 

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Senate Bill Calls Attention to Vision Health

(ARLINGTON, Va.) – The Health Care Alliance for Patient Safety (Alliance) today applauded the United States Senate, which last Thursday passed a bill that instructed the Centers for Disease Control and Prevention (CDC) to examine eye health research findings to increase patients’ vision safety and to update its reports on the burdens of keratitis – inflammation of clear tissue on the front of the cornea – and contact lens-related infections.

“The Health Care Alliance for Patient Safety has worked diligently with lawmakers to ensure patients have a more complete understanding of vision health facts and potential dangers from using contact lenses sold by online retailers that may not have been prescribed, verified and properly fit by an eye doctor,” said Alliance Chairwoman Dr. Deanna Alexander, O.D. “Our members and patient safety advocates are eager to continue working with lawmakers, the Centers for Disease Control and Prevention, and relevant agencies to ensure that patients have access to proper data to make informed decisions regarding their vision health.”

Specifically, the bill states:

“Vision Health.—Vision impairment often occurs as a co-morbidity with other chronic illness, such as chronic heart disease, stroke, depression, and smoking, at substantially higher rates than individuals without vision impairment. CDC is encouraged to apply previous CDC vision and eye health research findings to develop effective prevention and early detection interventions, and to incorporate vision and eye health promotion activities into existing State and national public health chronic disease initiatives, with an initial focus on early detection of diabetic retinopathy. In addition, the Committee encourages CDC to update its reports on the estimated burden of keratitis and contact lens-related infections.”

The bill passed the U.S. Senate with bipartisan support, 85-7.

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.

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Sightbox Announced as Alliance Member

(ARLINGTON, Va.) - The Health Care Alliance for Patient Safety (Alliance) today announced that Sightbox is the organization’s newest member. Sightbox is an eye health membership service that partners with the patient and the patient’s doctor for an in-person eye health exam, vision test and contact lens fitting, to ensure the medical device is properly fitted, the prescription is verified and submitted by the doctor, and a safe and ample supply of contact lenses is delivered directly to the patient over the following twelve months.

“The Alliance is excited to welcome Sightbox as an associate member,” said Alliance Chair Deanna Alexander, O.D. “Sightbox recognizes the importance of comprehensive eye care and preserving the doctor-patient relationship so our patients continue to receive the highest quality eye care.”

Sightbox joins the Alliance as an associate member. Alliance founding members include leadership member the American Optometric Association, leadership member Johnson & Johnson Vision and associate member CooperVision. VSP joined the Alliance as a leadership member.

“We know that there is no replacement for a qualified eye care professional, and that the best quality eye care can only happen through a strong doctor-patient relationship,” said Travis Rush, CEO of Sightbox. “That is why we are proud to join the Alliance in helping to ensure that nothing gets in the way of high-quality eye care for patients.”

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

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APS Champions Patient Safety in D.C.

(ALRINGTON, Va.) - The Health Care Alliance for Patient Safety (Alliance) this week held its “Day on the Hill,” with vision doctors from across the United States sharing insights and data with policy makers.

Esteemed doctors of optometry representing the Alliance met with White House officials, Members of Congress, Congressional staff and health regulators, discussing the importance of maintaining a strong doctor-patient relationship, the necessity of safe, healthy and effective use of medical devices, protecting prescription integrity and regulatory enforcement.

Dr. Jim DeVleming and Dr. Jacquie Bowen met with White House staff to both President Donald J. Trump and Vice President Michael R. Pence, briefing them on the Alliance’s legislative and regulatory priorities.

As some Alliance leaders were at the White House, others went to Capitol Hill to meet with Members of Congress. Following meetings with individual Members, Alliance Chair Deanna Alexander, O.D., moderated an informative panel at the Rayburn House Office Building. The panel included Michele L. Andrews, O.D., CooperVision; Carol L. Alexander, O.D, Johnson & Johnson Vision Care; and the immediate Past-President of Contact Lens & Cornea Section of the American Optometric Association, Jeffrey Sonsino, O.D.

The panel called attention to the proposed Contact Lens Rule, which is currently under consideration by the Federal Trade Commission (FTC). Attendees were surprised to learn of how some online retailers bend current rules.

The panel explored the need to reform rules surrounding the prescription verification process, illustrating how rules are bent by playing a recording of a robocall from Jan. 1, 2018 – a national holiday in which most businesses are closed. This recording demonstrates retailers using computer-generated recordings that lack basic, necessary information like a patent’s name, to verify prescriptions.

As the panel pointed out, it is impossible to verify a prescription if a vision doctor is not given the name of the individual to crosscheck the prescription details. In addition, the robocall audio is nearly unintelligible even when listening intently for content. The robocall can be downloaded here: http://bit.ly/2KewJxQ

The panel also shared an informational video produced by the Centers for Disease Control and Prevention (CDC), which highlights the importance of proper contact lens care. In the CDC’s video, a University of Alabama football player shares his story about how improper care led to Acanthamoeba keratitis, an infection of the eye. This condition has caused permanent vision loss for the patient and will require him to have a major eye procedure in an effort to restore vision.

The “Day on the Hill” and Congressional briefing concluded with panelists and Alliance champions urging attendees to encourage the FTC to consider these and other examples when finalizing the Contact Lens Rule. Following the briefing, panelists took questions from Congressional staffers.

Interested parties can access photos of Alliance champions advocating for patient safety here: http://bit.ly/2HxNaDM. Photo credit can be attributed to the Health Care Alliance for Patient Safety. 

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APS Congressional Day on the Hill

The Health Care Alliance for Patient Safety (Alliance) this week held its “Day on the Hill,” with vision doctors from across the United States sharing insights and data with policy makers. Below are several scenes from our time spent with policy makers. 

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Hill Briefing on Contact Lens Safety

(ARLINGTON, VA) – The Health Care Alliance for Patient Safety (Alliance) will hold a congressional briefing on Tuesday, April 24, 2018, from Noon-1 p.m. in The Rayburn House Office Building, Room 2247, to discuss the importance of protecting the safety of patients who use contact lenses, which are regulated medical devices.

Attendees at the briefing will include vision care professionals, congressional staff and Alliance champions.

The briefing will include a panel that focuses on four key areas:

  1. Maintaining a strong doctor-patient relationship when it comes to contact lens prescriptions, especially with the emergence of dangerous, abusive or harmful medical device marketing practices that increase patients’ risk for harm.
  2. The importance of the safe, healthy and effective use of medical devices, including contact lenses, while discussing advancements in technology to create better patient outcomes.
  3. The recognition of the inviolability of a patient’s prescription, determined through consultation between a patient and his or her doctor.
  4. Regulatory enforcement and strengthening of patient health and safety rules and laws.

The panel will be moderated by Alliance Chair Deanna Alexander, O.D. The panelists will include:

  • Michele L. Andrews, OD – CooperVision, Senior Director, North America Professional and Academic Affairs
  • Carol L. Alexander, OD – Johnson & Johnson Vision, Director, Professional Education and Development
  • Jeff Sonsino, OD – American Optometric Association, Past- President of Contact Lens & Cornea Section; Private Practice, Nashville, TN

Congressional briefing details are as follows:

Tuesday, April 24, 2018

Noon: Health Care Alliance for Patient Safety holds Congressional Briefing on Safety of Contact Lenses as Regulated Medical Devices

The Rayburn House Office Building – Room 2247
45 Independence Ave., SW
Washington, D.C.

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For media inquiries, contact mediatoday@patientsafetytoday.com

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