Archive December 2017 XVIII, No. 12

Take a Closer Look at Ophthalmic Compounded Drugs

Here's what you can do to ensure the sterility, potency and purity of the outsourced injections you use in your facility.

Daniel Cook

Daniel Cook, Executive Editor


compounded steroid-antibiotic INJECTION TROUBLE A compounded steroid-antibiotic formulation may be the cause of vision loss in dozens of patients who underwent surgery at 2 Dallas-area surgery centers.

If all you know about compounding pharmacies is what you've read in the news, recent headlines have probably left you shaken. After all, a compounding pharmacy prepared the epidural steroid injections for patients with back pain that led to a 2012 meningitis outbreak that killed dozens and sickened hundreds. And this year, a compounding pharmacy prepared the "dropless" steroid-antibiotic combinations that diminished the visual function of more than 40 patients who received the intravitreal injections at the end of cataract surgery. The patients developed various 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 evaluating the triamcinolone-moxifloxacin compound. In a statement to Outpatient Surgery, Guardian Pharmacy Services says it "is committed 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 pharmacy has been named as a defendant in one matter regarding compounded triamcinolone-moxifloxacin, no connection has been established between any Guardian product and the unfortunate adverse event alleged in the lawsuit."

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