A recent position paper endorsed by the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, the American Glaucoma Society and the Outpatient Ophthalmic Surgery Society, addresses the environmental and economic impact of medication waste in ophthalmic surgery.
A study1 of four cataract surgical centers in 2019 analyzed how much of an impact topical, injectable and systemic medication waste had on the environment, as well as the economic cost. At all four sites, nearly half of all drugs, and two-thirds of topical drugs, were thrown out after one use, amounting to approximately $195,000 wasted annually per location. Authors equated this to 23,000 to 105,000 metric tons of CO2 emissions for each site.
This prompted the Ophthalmic Instrument Cleaning and Sterilization (OICS) task force, which includes representatives from ASCRS, AAO, AGS and OOSS, to further research the issue. “Surgical drug waste significantly increases the cost and environmental footprint of ophthalmic surgery,” states David Chang, MD, co-chair of the task force. “In our 2020 survey, nearly all (98 percent) ophthalmologists said they were willing to use multidose bottles of topical medication on multiple patients at their surgical facility. However, less than half were actually doing so.”
The task force presented three consensus recommendations for safe and responsible use of perioperative topical medications, all of which have been endorsed by the aforementioned four eye-care societies.
The task force’s first recommendation is that topical drugs in multidose containers be used on multiple patients in surgical facilities as long as proper guidelines are followed. Although studies have shown no evidence of bottle tip or solution contamination, when proper guidelines were followed, some surgical facilities have instituted rules that multiuse bottles of eyedrops be discarded after being used by just one patient.
Cathleen McCabe, MD, co-chair of the OICS task force, says there are some steps surgeons can take to ensure they’re following proper guidelines. “The medication should be properly labeled, handled and stored according to manufacturers’ and CDC guidelines,” she says. “Staff who administer the medication should understand safe practices and practice infection control measures (i.e., avoiding touching the bottle tip to any surface including lids or lashes of the patient or the finger of the person administering the drop, and discarding the bottle if it’s compromised).”
The second recommendation is that topical drugs in multidose containers be used until the manufacturer’s labeled date of expiration if, once again, proper guidelines are followed. In an unpublished 2021 study by the OOSS, ASCs reported discarding partially used multidose topical eyedrop bottles at the end of the day (9 percent), the week (3 percent) or month (72 percent). Only 12 percent continued to use the bottle until its labeled expiration date.
Some of this may be attributed to conflicting and confusing guidelines set out by different agencies, such as a 2015 policy2 from the Centers for Medicare & Medicaid Services that references a 28-day expiration for infusible and injectable medications, but makes no specific reference to multidose eyedrop bottles. The OICS task force communicated directly with CMS and confirmed that this policy doesn’t apply to multidose eyedrop bottles, so therefore it doesn’t prevent surgical facilities from using them up until their expiration date.
“In order to safely keep and use topical medications until the expiration date they must be stored at the proper temperature and discarded on the expiration date,” Dr. McCabe advises. “Proper instillation technique should be followed to avoid contaminating the tip, and the bottle should be discarded if it becomes compromised.”
The task force’s third recommendation is that, when applicable, patients should be able to bring their partially used medication home for postoperative use. Surgical patients requiring the continuation of topical medications postoperatively are often required to purchase that medication at a pharmacy, as opposed to bringing it home from the surgery center, which is wasteful and unnecessarily burdensome, according to the task force. However, it recognized the inconsistencies among state- and facility-specific regulations which may prohibit this recommendation. Ophthalmologists may need to address this in a legislative manner state by state and the AAO has created a template to assist, available at https://www.dropbox.com/s/y7bl1pilh9ftfjc/MedicalWastePacket.pdf?dl=0.
Dr. McCabe says obstacles to adopting these recommendations remain. “The biggest obstacle is in educating facilities that the stated recommendations are consistent with FDA and CMS recommendations and that it’s safe to adopt these strategies to reduce pharmaceutical waste without compromising patient safety or risking a citation by a regulatory body,” she says. “In some cases, the policies and procedures of the facility may need to be changed to reflect the recommendations. CMS inspectors will also need to be educated that these are approved guidelines and facilities should not be cited for following them.”
The paper has raised awareness, Dr. Chang adds, which he hopes will spur action. “Since it was released in April 2022, nearly every state ophthalmology society has also endorsed this position statement.”
1. Tauber J, Chinwuba I, Kleyn D, Rothschild M, Kahn J, Thiel CL. Quantification of the cost and potential environmental effects of unused pharmaceutical products in cataract surgery. JAMA Ophthalmol 2019;137;1156–1163.
2. Center for Clinical Standards and Quality/Survey & Certification Group. CMS Memorandum S&C: 15-43- ASC: Advanced copy: update to ambulatory surgical center (ASC) infection control surveyor worksheet (ICSW). Centers for Medicare & Medicaid Services, June 2015.
Byooviz Launches, Beovu Receives DME Update
Last month, Beovu for DME (brolucizumab-dbll, Novartis) and Lucentis biosimilar Byooviz (ranibizumab-nuna, Biogen and Samsung Bioepis) were granted FDA approval, giving retinal specialists two more options for treating retinal disease. Byooviz, the first FDA-approved ophthalmic biosimilar, is now commercially available through major U.S. distributors with a list price of $1,130 per single-use vial.
“We’re incredibly fortunate to be at a point in time where multiple effective therapies are available for our patients with vision-threatening retinal conditions,” says Jason Hsu, MD, of the Wills Eye Retina Service in Philadelphia. “The approval of Byooviz is a landmark in our field as the first biosimilar drug to ranibizumab for patients with neovascular age-related macular degeneration, retinal vein occlusion and myopic choroidal neovascularization. Beovu will be another option in our growing armamentarium for patients with diabetic macular edema.”
Dr. Hsu says he believes that Beovu will continue to be a second-line therapy, even for patients with diabetic macular edema. “While the Phase III trials did demonstrate that it was non-inferior to Eylea, even with less frequent dosing, I think many of us are still scarred by concerns about intraocular inflammation and retinal vasculitis with our earlier Beovu experience in AMD,” he says.
“The occurrence of retinal vasculitis was only 4 of 566 patients in KESTREL and none of the 360 patients in KITE, but this still gives me pause to recommend this drug as a first line treatment,” he says. “In addition, the incidence of intraocular inflammation was higher in the Beovu arms at around 4.7 percent in KESTREL and 2.2 percent in KITE compared to 1.1 to 1.7 percent with Eylea. Ultimately, we’ll have to see what the real-world experience looks like as more patients receive Beovu for DME to understand if the inflammatory issues are really lower than what has been historically seen for neovascular AMD.”
He points out that with Vabysmo’s recent FDA approval for DME in addition to neovascular AMD, retinal specialists already have “a more durable biologic agent which may have potentially less risk.” Though the Vabysmo Phase III trials were designed differently from the Beovu ones, one difference Dr. Hsu says stands out is that “more than three-quarters of patients were able to achieve 12-week or more dosing intervals with Vabysmo versus only one-third to less than a half with Beovu by the end of year two.
“I think Byooviz will be a little more complicated in terms of how it impacts drug choice for patients,” he says. “Since it’s a biosimilar to Lucentis that’s slated to cost 40 percent less, it may be an excellent alternative that’ll potentially save costs for the health-care system and patients. On the flip side, we have other drugs that seem to last longer, such as Eylea and Vabysmo, that are already available. Therefore, if payers institute stringent requirements to use Byooviz over other alternatives, it’s possible the cost savings impact may be blunted if one ends up having to use Byooviz twice as often as Eylea or Vabysmo, not to mention the greater burden of treatment for patients.
“Lucentis has been available since 2006 and has an outstanding safety record in countless patients spanning more than 15 years,” he continues. “In contrast, the process for FDA approval of a biosimilar is more abbreviated. In this case, only about 350 patients were randomized to receive Byooviz in the clinical trial, and the primary endpoint occurred at eight weeks. Therefore, we currently have no robust, long-term clinical data on the safety and efficacy of this biosimilar.
“It’s important to understand that Byooviz is a ‘biosimilar’ and not a ‘bioidentical,’ ” he says. “Other biosimilars have sometimes been found to cause uncommon side effects that only become apparent as the drug is used in larger populations. For example, an erythropoietin biosimilar used to treat anemia was found to have a higher risk of inducing pure red cell aplasia. Since it was relatively uncommon, it was not seen in the clinical trials. A large, long-term pharmacovigilance study will be important to reassure patients and physicians of the safety of this new biosimilar.”
Other ranibizumab biosimilars are currently making their way through the development and/or trial stages, including FYB201 (Coherus, Bioeq) and Xlucane (Xbrane Biopharma, Bausch + Lomb).