(NEW YORK) — The Food and Drug Administration is weighing whether or not surgeons should provide additional warnings about the risks of Lasik, a popular corrective eye-sight surgery.

In a draft guidance from July, the agency suggested that patients should be explicitly informed about the risks of dry eye, problems driving at night, visual disturbances — or other rare but more serious side effects related to the surgery.

The FDA is still finalizing the guidance. If implemented, companies would be asked to create a checklist of possible risks and surgeons would be asked to go through that checklist with patients to ensure they understand the possible risks and benefits of the procedure.

An FDA spokesperson said in a statement, “The FDA issued a draft guidance in July 2022 that recommends content and formatting for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices. As part of the guidance process, this document was published in the Federal Register, giving the public an opportunity to comment. The comment period for the draft guidance recently closed on November 25, 2022. With the comment period now closed, the FDA is now reviewing and considering comments for the final guidance. The timeline for the final guidance issuing is dependent on a number of factors and we cannot provide a firm timeline at this point.”

The American Academy of Opthalmology weighed in on the proposed guidance and raised concerns about the checklist.

“Much of the content presented is important for the informed consent process but it is presented with insufficient depth and nuance,” said Dr. Stephen McLeod, CEO of the academy. “The academy’s position is that effective informed consent is a process of shared information and decision-making that occurs between the physician and the patient. Risks and benefits do not exist in a vacuum, and for them to be meaningful rather than abstract, they must be interpreted and discussed in the context of a specific patient. We are also concerned that there are several statements that are not well supported by the latest evidence, and some that have actually been disproved.”

According to the FDA, Lasik is a procedure intended to reduce a person’s dependency on glasses or contact lenses. The agency said that the surgery is one of the most commonly performed and estimated that nearly 600,000 Lasik surgeries are performed each year.

In a video, the agency summarizes some risks to the procedure, stating that “Lasik is not for everyone.”

The newly drafted guidance succeeds two previous FDA measures on disclosing the risks of Lasik surgery.

In May 2009, the FDA issued a letter to eye care professionals providing them with important information about promoting and advertising Lasik after receiving complaints that consumers were not told of the risks associated with the procedure.

Two years later, the FDA issued a second letter “to remind eye care professionals of their legal responsibility to provide balanced information about medical products,” including disclosing risk information in eye care professionals’ promotional material.

In 2017, after the agency reportedly received complaints about side effects from the surgery, from dry eye to more serious stories of chronic eye pain, it commissioned studies to investigate whether patients were being adequately informed about risks, as well as clear benefits.

The 2022 draft guidance suggests that manufacturers and surgeons should explicitly walk patients through a “checklist” that includes clear warnings and benefits.

The drafted Lasik “checklist” includes part of the following.

Six months after surgery:

• Up to 27% of patients experience dry eye symptoms
• About 41% of patients may experience visual symptoms such as glare, halos, starbursts or double images
• Around 4% of patients may have “very” or “extremely” bothersome symptoms
• Around 2% of patients may have “a lot of difficulty” when not wearing glasses or contacts

Five years after surgery:

• About 17% of patients still used eye drops for dry eyes
• Fewer than 2% of patients still notice some visual disturbance
• About 8% of patients have trouble driving at night
• There are rare (fewer than 1%) reports of severe, constant pain

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(NEW YORK) — Walgreens has launched a new delivery service for the COVID-19 oral antiviral therapy Paxlovid in partnership with DoorDash and Uber to get the treatment “directly to the doorsteps of those who need it.”

Walgreens on Thursday said it has more than 8,000 locations offering same-day delivery services, available to anyone who lives within 15 miles of participating stores. Walgreens said that means real access to a lot of Americans — offering it to roughly 92% of the population.

That’s the whole point of this initiative, Walgreens said — increasing access to COVID treatments — with “a focus on reaching those in socially vulnerable or medically underserved areas at a time when COVID-19 cases are beginning to rise again across the United States.”

Paxlovid, from Pfizer, is one of the few treatments still expected to hold up against currently circulating subvariants and comes as coronavirus hospitalizations are trending upward in the elderly.

The drug stops the virus from replicating in the body and works best when taken within five days of getting symptoms. It has proven highly effective at reducing the risk of hospitalization and preventing higher-risk patients from getting even sicker.

To use Walgreens’ new delivery service, eligible patients must have a Paxlovid prescription from a health care provider.

After the pharmacy has filled the prescription, and before it gets picked up, individuals can go online to select Same Day Delivery by visiting Walgreens.com/PrescriptionDelivery, using the Walgreens app or by calling their local store.

To use Same Day Rx Delivery, customers must be opted into Prescription Status Alerts, which will appear as an option if an order is before a particular store’s cutoff time on a given day. Walgreens noted that certain health plans do not cover or participate in Same Day Rx Delivery, and it advised customers to check with individual health plan providers for further details. They also noted that while most prescriptions are “expected to be delivered same day, some deliveries may not be eligible for delivery due to prescription type, delivery address, holidays, weather or other delivery constraints.”

“The COVID-19 pandemic has exacerbated health disparities and emphasized the need to address long-standing barriers, including access to treatments,” Anita Patel, PharmD, vice president of pharmacy services development at Walgreens, said in a statement. “Our pharmacy teams will continue to play a trusted and essential role in helping to keep people protected from COVID-19, including getting people vaccinated, tested and treated as safely, equitably and effectively as possible.”

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