Eyeworld

EW FEATURE 48 Controversies in ophthalmology • June 2016 AT A GLANCE • Concerns continue among some that improperly mixed pharmacy preparations could produce toxic anterior segment syndrome (TASS). • Eighty-four percent of respondents to a 2014 ASCRS survey said that they would use a commercially approved intracameral antibiotic if it were available at a reasonable cost. • U.S. endophthalmitis rates remain below those of patients treated in an ESCRS intracameral antibiotics study. by Rich Daly EyeWorld Contributing Writer Amid American ophthalmologists' continued wariness of intracameral antibiotic use, physicians address some of the lingering concerns A lthough intracameral antibiotic use during cataract surgery has been embraced by nearly half of U.S. ophthalmologists, according to the latest survey data, lingering concerns have limited its appeal to others. 1 However, the promise of effec- tive protection for the 3 million patients undergoing cataract proce- dures has fueled ongoing interest in the status of those concerns. "The general sentiment is that every U.S. ophthalmologist would inject an antibiotic if it was [Food and Drug Administration] approved and commercially prepared and there was no question that there was going to be a dilution error," said Kevin M. Miller, MD, chief, cata- ract and refractive surgery division, David Geffen School of Medicine at UCLA. Widespread European use of a trial-tested formulation of cefurox- ime (Aprokam, Thea Pharmaceuti- cals, Newcastle Under Lyme, U.K.) demonstrates the appeal of such a treatment option. However, without a commercial option specifically approved for the purpose, U.S. surgeons continue to weigh alternatives. Those options had no TASS cases reported in its network for many years. Some ophthalmologists have become more comfortable with compounding pharmacies since fed- eral legislation tightened the quality standards and increased oversight by the FDA from sometimes infrequent inspections by state agencies. "The FDA is generally accepted as the most diligent inspector of fa- cilities and processes," said William Myers, MD, health services clini- cian, Department of Ophthalmol- ogy, Feinberg School of Medicine, Northwestern University, Chicago. "That is why manufactured products are generally considered safe," Dr. Myers said. Survey on antibiotic prophylaxis David F. Chang, MD, clinical pro- fessor, University of California, San Francisco, and the Cataract Clinical Committee conducted a survey of ASCRS members regarding antibiotic include the use of moxifloxacin and vancomycin, as well as a product that combines antibiotics and ste- roids. TASS questions Among the leading concerns about intracameral antibiotic use is the possibility that improperly mixed pharmacy preparations could pro- duce toxic anterior segment syn- drome (TASS). "If someone gets endophthal- mitis, it's considered bad luck," Dr. Miller said. "If someone gets TASS, it's considered the surgeon's fault or the system's fault for causing that reaction. So a lot of us are nervous about causing TASS, especially in work environments where numerous different individuals mix up phar- maceuticals." The TASS concerns have been enough to keep Dr. Miller from utilizing intracameral injections, but other surgeons have found that FDA-approved compounding pharmacies have provided reliable antibiotic injections. For instance, Neal Shorstein, MD, associate chief of quality, Kaiser Permanente, Walnut Creek, Cali- fornia, uses intracameral antibiotics prepared for use by Leiter's Com- pounding Pharmacy (San Jose, Cali- fornia), a 503b "outsourcing facili- ty," which is inspected by the FDA and follows current good manufac- turing practices—the same required by pharmaceutical manufacturers. "This is a higher level of sterility and sophistication in processing and oversight than in non-503b compounding pharmacies," Dr. Shorstein said. The compounding pharmacy checks for sterility and correct con- centration, which greatly minimizes risk of contamination and dilution error, Dr. Shorstein noted. This has contributed to the result that Kaiser Permanente Northern California has Examining U.S. doubts on intracameral antibiotic use Transzonular intravitreal injection of a commercial formulation of triamcinolone acetonide and moxifloxacin or triamcinolone, moxifloxacin, and vancomycin Source: Jeffrey Liegner, MD

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