MAR 2014

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

Issue link: https://digital.eyeworld.org/i/276058

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Page 135 of 210

E W GLAUCOMA 1 33 "This is a significant issue with the prostaglandins," he said. The bottles are small and require practice to squeeze appropriately for single d rop dosing. "Not all bottles of generic latanoprost have the same shape or stiffness." This can be problematic for patients who may squeeze less stiff bottles too hard and waste drug, or who may have arthritis and are unable to squeeze stiffer bottles. Also, as it turns out, generics are r equired to use the exact same pre- scribing information as the branded product—and because of this, are legally not held responsible for any of the content of the prescribing information. "This has the effect of disincen- tivizing post-market surveillance of safety issues by generic producers," said Dr. Kahook. There is no incen- tive to proactively monitor safety and regularly update the prescribing information with new safety data if the generic manufacturer cannot be held liable for an incomplete disclo- sure of safety in the prescribing information. The FDA has proposed a new rule to address this issue, he said. Clinical impact Dr. Chambers encourages the use of generic drugs. "We should save our limited resources by using generics when available, and spend those re- sources developing innovator drugs for new indications." Dr. Kahook readily agrees. "I use generics every day, and they are generally safe and effective." He cautions, however, that physicians should be aware that non-brand, non-generic formulations of com- monly used eye medications are in the U.S. marketplace. "All of my patients know to bring all of their drops to every visit so I can see exactly what formulation they are using," he said. When commonly used drugs go generic, it is incumbent upon physi- cians to remain vigilant for safety and efficacy issues. "The burden is on the physician and not the FDA to ensure that generics are safe for our patients," Dr. Kahook said. EW Editors' note: Dr. Chambers has no financial interests related to this article. Dr. Kahook has financial interests with Abbott Medical Optics (Santa Ana, Calif.), Aerie (Bedminster, N.J.), Alcon (Fort Worth, Texas), Allergan (Irvine, Calif.), ClarVista Medical (Aliso Viejo, Calif.), Genentech (San Francisco), G laukos (Laguna Hills, Calif.), Innovative Laser Technologies (Minneapolis), Ivantis (Irvine, Calif.), Merck (Whitehouse Station, N.J.), Regeneron (Tarrytown, N.Y.), Shape O phthalmics (Denver), ShapeTech (Denver), and Valeant (Bridgewater, N.J.). Contact information C hambers: wiley.chambers@fda.hhs.gov Kahook: malik.kahook@gmail.com February 2011 March 2014 130-135 Glaucoma_EW March 2014-DL2_Layout 1 3/6/14 4:12 PM Page 133

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