Eyeworld

MAY 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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32 EW FEATURE February 2011 Perioperative pharmacology May 2012 Groundswell for NSAIDs in CME battle by Maxine Lipner Senior EyeWorld Contributing Editor AT A GLANCE • CME can translate into decreased acuity and contrast sensitivity • Practitioners must weigh the expense of NSAID use against the cost of treating CME • The frequency of NSAID use is doc- tor-driven with no clear guidelines Why practitioners see NSAIDs as a pivotal component N early all cataract practi- tioners will tell you that NSAIDs are a vital part of practices' cystoid macular edema (CME) fighting regimen, despite the fact that this is an off-label use. "Some of the sur- veys suggest that in approximately 80% of cataract cases performed in the United States, patients are treated with topical NSAIDs at some point," said Michael B. Raizman, M.D., associate professor of ophthal- mology, Tufts University School of Medicine, Boston. EyeWorld asked leading practitioners to share their thinking here. Clear evidence Dr. Raizman, who sees NSAIDs as an integral part of the CME prevention regimen, presented a randomized controlled study on prevention of CME with non-steroidal medication in 1999. The study in Investigative Ophthalmology and Visual Science compared the use of non-steroidal drugs together with steroids versus steroids alone. He found that 12% of low-risk patients given steroids alone developed CME compared with none of those who were treated with NSAIDs. In another pivotal study in the October 2008 issue of the American Journal of Ophthalmology, investiga- tors led by John R. Wittpenn, M.D., explored whether the addition of pe- rioperative topical ketorolac should be used with steroids in routine cases without known risk factors for cystoid macular edema. "The argu- ment was that it's not worth it to use NSAIDs for these (low-risk) pa- tients because they're not going to get CME," said Dr. Wittpenn, associ- ate clinical professor, ophthalmol- ogy department, Stony Brook University, Stony Brook, N.Y. How- ever, the study found that even low- risk patients were not immune to CME. These patients had a 2.5% risk of definite CME without the NSAID and virtually no CME risk with the drug. Meanwhile, for subclinical CME there was an 8.9% risk, making the risk together 11-12% for those who received steroid alone versus just 5% with the NSAID. Clinical consequences For Johnny L. Gayton, M.D., ad- junct professor of ophthalmology, Mercer Medical School, Warner Robins, Ga., the clinical value indi- cated by the study is clear. "Dr. Wittpenn showed that a 10-micron thickening of the macular resulted in decreased contrast sensitivity," he said. For clinically significant CME this can translate into post-cataract acuity of 20/40 or worse. "Who's going to accept that?" he said. He also sees simple macular thickening as problematic. Dr. Gayton gave the analogy of using a fire hose on your carpet. "Ultimately you may get all of the water out, but that carpet won't ever fit like it did," he said. He pointed out that one of the risks here is reduced contrast sensitivity, and especially in the era of premium lenses, this can have se- Corneal melt: Freezing out generic NSAIDs W hen it comes to corneal melts, practitioners remember back in 1999 when unbranded diclofenac was associated with unexplained melts. Now the problem with generic NSAIDs may be rearing up again, according to Dr. Wittpenn. "Now that the second round of generics has come out we're seeing similar problems," Dr. Wittpenn said. "We see them reported with all of the different generic [NSAIDs]." In Dr. Wittpenn's office there was recently a situation involving a cataract patient who, unbeknownst to one of his partners, had been switched to generic ketorolac by a pharmacist. "He had written a prescrip- tion for Acuvail (Allergan, Irvine, Calif.) brand ketorolac," Dr. Wittpenn said. "It was filled by the pharmacist with generic ketorolac, unbeknownst to the doctor." The pharmacist assured the patient that the branded NSAID and the generic were exactly the same, pointing to ketorolac as the active ingredient. "When the patient returned and was asked, 'Are you taking Acuvail?' she said, 'Yes, I'm taking exactly what you prescribed,'" Dr. Wittpenn said. The truth didn't emerge until 2 or 3 weeks after surgery when the patient returned with a frank melt. "It was only when they had her bring the drops in that they realized that [it wasn't] Acuvail, [it was] generic ketorolac," Dr. Wittpenn said. The fact is that the active ingredient is just one part of the drug. Unlike with systemic medications, other components can have a dramatic impact in the eye. "We don't have the stomach and the digestive system as a defense barrier to problems with a generic formulation," Dr. Wittpenn said. NSAIDs are very prone to ocular surface problems possibly because they have some anesthetic effect, Dr. Wittpenn thinks. "We have long known that an anesthetic effect on the ocular surface begins to disrupt things," he said. While the patient ultimately fared reasonably well with somewhat of a scar along with 20/40 acuity, Dr. Wittpenn finds that the fear of melt is having an impact in ophthalmic offices. "Physicians are starting to veer away from the non-steroidals a bit because in a busy office, you tire of battling the pharmacies and the patients who say, 'It isn't covered so why can't I have the generic?'" Dr. Wittpenn said. While Dr. Wittpenn spends time detailing the situation for patients, he finds that approximately 25% still wish to switch to the generic med- ication. While the patient in this situation was understanding about the complication, he worries about surgeon liability. "Have we reached the point where we need to have [patients] sign a consent or at least a form saying that they're aware that we don't recommend generics for this rea- son?" he asked. Dr. Gayton thinks so. "We have a consent written up that talks about the advantages and disadvantages of the branded versus the generic non- steroidals and all of our medications," he said. It is then up to the patient to choose whether he or she wants the branded or the generic product. If patients can only afford one branded medication, however, Dr. The case pictured here required complete tarsorrhaphy and punctal plugs, and the patient ultimately healed with a residual scar and 20/40 vision Source: John R. Wittpenn, M.D. Gayton steers them toward the NSAID. "The risk of endophthalmitis is quite low, the risk of intractable inflammation from decreased potency on a steroid is quite low, but the risk of CME is pretty high; the thing that has the most impact on your final result is typically whether or not there is macular edema," Dr. Gayton said. "So the product that is most likely to have a positive impact on your visual outcome is the branded non- steroidal."

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