Join Renowned Experts for Symposium Titled Off-Label Drugs for Anterior Segment Surgery: What Can I Use and How Can I Stay Out of Trouble?
What are our options for cataract surgical antibiotic prophylaxis and what limits them? How do I know if a compounding pharmacy’s products are safe? Hear what experts, including the FDA’s director for ophthalmic drug product review, have to say about the regulatory, approval and access issues involving off-label drugs and compounding pharmacies.
The access to and use of off-label drugs in anterior segment surgery has always raised concerns. With compounding pharmacies under increased scrutiny and regulation, the options may be decreasing rather than increasing.
“New studies and the emergence of HORV have many surgeons re-considering what to use for endophthalmitis prophylaxis,” says Dr. David Chang. “Understanding the regulatory issues surrounding compounding pharmacies, FDA drug approval and off-label prescribing and marketing is important for all anterior segment surgeons.”
David F Chang, MD – past president of ASCRS, co-chair of the ASCRS/ASRS HORV Task Force, and a practicing ophthalmologist in Los Altos, CA – will discuss the conundrum that all ophthalmologists currently face regarding antibiotic prophylaxis for cataract surgery. The issues that limit patient access and physician education include restrictions on off-label promotion of topical antibiotic prophylaxis, barriers to FDA approval of commercial intracameral antibiotic formulations, off-label intracameral injection of topical and systemic antibiotics, and increasingly strict regulations governing compounding pharmacies.
R. Doyle Stulting, MD, PhD – past president of ASCRS, co-founder of the Stulting Research Center in Atlanta, GA, director of Corneal Disease & Research at Woolfson Eye Institute and professor of ophthalmology, Emeritus at Emory University – will walk you through the current regulatory environment. He will discuss innovative ways to ensure providers have access to truthful and scientifically accurate information.
Charles Leiter, Pharm. D., one of the world’s leading ophthalmic pharmacists, will discuss the more recent issues and challenges confronting compounding pharmacies.
Wiley Chambers, MD – deputy director of the Division of Transplant and Ophthalmology Products Center for Drug Evaluation and Research – will provide a regulatory perspective from the FDA on off-label communication and will discuss policy options to support the dissemination of accurate information to ensure better patient care.
Don’t miss this and many other valuable educational opportunities. Register today for the ASCRS annual meeting. You can view the entire program using the online Real-Time Program.