Compounding pharmacies have stepped into the breach created by a lack of FDA-approved infection and inflammation prophylaxis for intraocular injection after cataract surgery. In the Dallas metropolitan area, however, one prominent practice is now trying to help a group of patients cope with the effects of what it says were injectable agents not prepared as represented.
Key-Whitman Eye Center, a practice with offices in Dallas and north Texas, has announced that some of its cataract-surgery patients who underwent routine procedures at the PRG Dallas Surgery Center between January 31 and February 21, 2017 developed vision problems after receiving intraoperative injections of a steroid/antibiotic compound.
According to Jeffrey Whitman, MD, president and chief surgeon of Key-Whitman Eye Center, his practice has identified 20 to 30 affected patients who had cataract procedures done at the physician-owned PRG Dallas Surgery Center, where Key-Whitman doctors, as well as surgeons from other practices, operate. “The way we were able to trace it back was that one doctor called in to advise that she had a couple of patients who were completely healed at three and four weeks, but they had developed decreased vision: These patients had noticed darkening in the center of their vision and no other symptoms. The doctor had them come in and get checked, and their corneas looked perfect. Their anterior chambers were clear. Their retinas looked good, so she sent them to a retina specialist to see if there was something we were missing,” Dr. Whitman explains. More calls from patients noting the same visual symptoms followed—all of whom had gotten the antibiotic/steroid injection during the same three-week span.
“We only gave that compounded medication during that three-week period,” says Dr. Whitman. “After that, we stopped using it and went back to our Imprimis product.” The injectable medication the affected patients received has been traced to a single batch compounded at Guardian Pharmacy Services (a Dallas-based, FDA-inspected specialty pharmacy that has never been affiliated with a similarly-named national institutional and long-term care pharmacy service based in Atlanta, Guardian Pharmacy Services LLC, or its partner, Guardian Pharmacy of Dallas-Fort Worth).
The consulting retinal specialist noted a change to the ellipsoid layer in the eyes of affected patients that was only detectable via OCT. Dr. Whitman said the retinal doctors explained that they’d seen similar changes in about 1 percent of patients undergoing Jetrea injections for vitreomacular adhesion, but that these changes had developed within 24 to 28 hours of treatment—not three to four weeks.
“There’s no example of this in the literature,” observes Dr. Whitman. “There are some examples of the vehicle being toxic under certain circumstances, but there’s no article or study. That’s a hard thing to have to tell our patients.”
Key-Whitman notified every patient who’d had the injection, once they had traced the source of the affected patients’ visual symptoms. They examined them at no cost and then referred the patients with problems to retinal specialists for free evaluations. They alerted other practices using the PRG Dallas Surgery Center, notified Guardian Pharmacy Services and the FDA, and also established a telephone hotline for affected patients. The surgery center’s legal counsel hired an independent pharmacist to study the compounded medicine at issue. “His thought was that the suspension was at a very high concentration, and he believed that may be what caused the retinal damage,” Dr. Whitman reports.
Attempts to reach Guardian Pharmacy Services were unsuccessful. “All they’ll say is that they’re studying it. I don’t know what that means,” says Dr. Whitman of the compounder, adding that Guardian Pharmacy Services is under a temporary restraining order from Dallas County Civil District Court that enjoins them from distributing or destroying any of the suspect medication and any related documentation. The FDA is also investigating, he says.
“We’re hurt and angry at the pharmacy,” says Dr. Whitman. “These are our patients. We don’t do a lot of co-management, and so we’ll see these patients forever.” He adds that some of the patients have recovered to normal or near-normal visual acuity; some are improving; but others have not. “We are watching the OCT scans with particular interest. In the patients that get better, you can see a re-forming of the ellipsoid layer,” he says.
To the best of Dr. Whitman’s knowledge, no patients have filed suit at this time, and Guardian Pharmacy Services has retained legal representation. “We continue to communicate with our patients and let them know what the progress is. Our legal representative has met with plaintiffs’ counsel because we want to work together,” he says.
Georgia ODs to Administer Injections
In late March, the Georgia House of Representatives and Senate approved a bill (SB 153, formerly SB 221) that allows optometrists to administer certain injections. Following the approval of the state legislature, Georgia Governor Nathan Deal signed the bill into law on May 9.
The law states: “A doctor of optometry may administer pharmaceutical agents related to the diagnosis or treatment of diseases and conditions of the eye and adnexa oculi by injection, except for sub-Tenon’s, retrobulbar, peribulbar, facial nerve block, subconjunctival anesthetic, dermal filler, intravenous injections, intramuscular injections, intraorbital nerve block, intraocular, or botulinum toxin injections.”1 In a statement from the Georgia Optometric Association (GOA), the GOA says the injections will likely be in the lid and/or to address warts and nodules.
Optometrists say they’re in favor of the bill’s passage because medications delivered via injection into the lid often have fewer side effects than oral medications. They add that the law will improve the medical treatment of diseases by giving patients easier access to care in areas not served by ophthalmologists.
In order to administer these injections, optometrists must hold a current license and obtain a certificate showing that they’ve completed an injectables training program sponsored by an accredited school or college of optometry, consisting of a minimum of 30 hours.
However, there is certainly opposition to the new injection law. Steven M. Walsh, MD, president of the Medical Association of Georgia, recently voiced his concerns with the motion. “The bill allows optometrists to make injections and perform other delicate procedures in and around a patient’s eye or eyelid—procedures they simply aren’t qualified to perform,” he says. “We should never cut corners when it comes to any aspect of our health care, but this is especially true when it comes to our eyes and our vision.”
He goes on to detail the potential dangers of these injections. “Any mistakes occurring during procedures that are conducted in or near the eye can have particularly dire consequences, including infections, blurred vision, hemorrhaging and loss of sight.”
The GOA, led by President Ben Casella, OD, applauds the bill’s approval. In an official statement, he states: “As the training for doctors of optometry continues to increase to keep up with advancing technology, it is essential for the state law to keep up as well. [This law] makes that possible."
“The process of treatment via injection has been taught, both didactically and clinically, in colleges of optometry for many years,” Dr. Casella says in a separate statement. “Consumers in more than 15 states have access to doctors of optometry authorized to perform these procedures, for which the doctors have received intensive training.”
In the GOA statement, Dr. Casella contends that the law will be a boon to the state in general. “Doctors of optometry graduating today may select where to practice based on their authorization to use the training they received during their extensive years of study,” Dr. Casella says. “We want to ensure that Georgia remains pro-business and continues to attract the brightest and best in the profession of optometry.” REVIEW
1. http://www.legis.ga.gov/Legislation/20172018/167640.pdf accessed 10 May 2017