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A Drug Diverter Comes Clean - Subscribe to Outpatient Surgery Magazine - December 2017

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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Page 80 of 166

D E C E M B E R 2 0 1 7 • O U T PA T I E N TS U R G E R Y. N E T • 8 1 injections at the end of cataract surgery. The patients developed vari- ous symptoms, including vision impairment, poor night vision, loss of color perception, light sensitivity, glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches and nausea, according to an FDA alert. In some cases, symptoms didn't appear until more than a month after surgery. When the outbreak was first discovered in April, cataract surgeon Jeffrey Whitman, MD, whose patients at 2 Dallas surgical centers were among those who suffered vision complications, told the Dallas Mercury News, "It's devastating in many ways. I've been practicing for 31 years to help people see better, and I feel a little bit hopeless. I'm more angry at the compounding pharmacy for making something that injured our patients." Dr. Whitman declined to comment for this story. At the time of the outbreak, Jack Munn, RPh, owner and president of Guardian Pharmacy Services, which compounded the intravitreal injections, told the Dallas Mercury News that Guardian was evaluat- ing the triamcinolone-moxifloxacin compound. In a statement to Outpatient Surgery, Guardian Pharmacy Services says it "is commit- ted to the quality and safety of all of its compounded products and has a rigorous quality assurance program in place. The health and well-being of our patients is our foremost concern. While the pharma- cy has been named as a defendant in one matter regarding compound- ed triamcinolone-moxifloxacin, no connection has been established between any Guardian product and the unfortunate adverse event alleged in the lawsuit." The incidents at the Dallas surgery centers likely won't be the last time compounded drugs will be called into question. Of the estimated 4,500 U.S. outsourcing pharmacies, only 73 are currently registered with the FDA, says Roy Sturgeon, PhD, a senior advisor at Lachman Consultant Services, a pharmaceutical consulting firm based in

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