EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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18 EW NEWS & OPINION March 2013 Chief medical editor's corner of the world Compounding pharmacies: Let's not throw the baby out with the bathwater by David F. Chang, M.D., Chief Medical Editor Dr. Chang: Tell us about Leiter's Pharmacy and how you got so involved with pharmaceutical compounding. T he disastrous fungal infections caused by contaminated medications from the New England Compounding Center (NECC) have rocked the pharmaceutical compounding industry. As a result of this horrible outbreak, the confidence of many physicians and their patients in compounded medications has been shaken. Of course, drug compounding has always filled important and otherwise unmet pharmaceutical needs. Thanks to Avastin (bevacizumab, Genentech, San Francisco), we ophthalmologists understand this as much as anyone. More recently, shortages in both bisulfitefree and bisulfite-preserved epinephrine would deprive us of an important strategy for IFIS and small pupils if it weren't for compounded phenylephrine. With the increased scrutiny and regulation that are sure to follow in the wake of the fungal meningitis outbreak, we must heed the idiom in this column's title and preserve patient access to appropriate and properly compounded medications. In ophthalmology, we are fortunate to have a number of reliable and leading compounding pharmacies such as Leiter's. I first learned about Leiter's upon hospitalizing a corneal ulcer patient during my first month of residency. The Proctor Foundation and UCSF had arranged with this local San Jose pharmacy to provide fortified antibiotic drops for corneal ulcers because the concentration of commercially manufactured topical antibiotics was inadequate. Beginning with those simple curbside requests, the evolution and growth of this family run pharmacy during the past three decades is itself an amazing story; indeed they have now become the largest ophthalmic compounding pharmacy in the country. Over the years, owner Chuck Leiter has also become a good personal friend. I've operated on his pharmacist father, Morton, and Chuck has been kind enough to serve as the licensure mandated "consulting" pharmacist to our single specialty ASC. For our compounding needs, Chuck has helped us with everything from intracameral 1.5% phenylephrine to our preoperative, multidrug-containing lidocaine gel slurry. For this month's column, I asked Chuck how this infectious outbreak could have happened and what repercussions this could have for the compounding industry. As you will see, there is only a small minority of compounding pharmacies that are accredited, and this is a very important distinction. David F. Chang, M.D., chief medical editor Mr. Leiter: I am a third generation pharmacist and the owner of an independent pharmacy that has been in my family for 85 years. I realized a long time ago that without specializing in niche pharmacy markets, we could not compete with the large pharmacy chains of the world, such as the Longs and Walgreens, because they could benefit from economies of scale; we needed to meet the growing customer demand in a niche like compounding in order to make our independent pharmacy successful. Just as small independent bookstores cannot compete with the Barnes & Nobles of the world, without filling a niche, neither can a small independent pharmacy. I've always had an interest in ophthalmology, and I knew a number of doctors in this field. We were approached by one local practice in the 1980s to compound preservative-free glaucoma meds, then fortified antibiotics, and the demand for our services grew from there. The internet played a big role in our growth because of the various "list servs" doctors use to share information. Now, we are one of the largest compounding pharmacies in the country and number one in ophthalmology. We were the first pharmacy in northern California to become Pharmacy Compounding Accreditation Board (PCAB) accredited in 2006. It is a very rigorous program to go through. This accreditation has been paramount to our growth and success. PCAB is the accrediting board that ensures a pharmacy follows USP 797, 795 standards. There are 162 pharmacies currently accredited out of more than 3,000 compounding pharmacies in the U.S. the largest HMOs in the country with their compounded medication needs. We currently have a staff of 60, including 15 pharmacists and 22 certified technicians. We continue to grow our business to meet increased customer demand. In August 2013, we will be expanding into a 22,000-square-foot facility that will include approximately 6,000 square feet of clean room and compounding. It is being built to current good manufacturing practice (GMP) specifications. These are the same specifications that manufacturers have to adhere to. In addition, we have hired a former FDA compliance officer as our quality control director to further demonstrate our commitment to quality and safety. Our motto and our commitment to every customer is "Quality Mr. Leiter and Dr. Chang without Compromise." We have never had to recall a drug or had any sterility issues in the more than 1,000,000 compounded prescriptions we have produced to date. Every batch is tested and quarantined until successful testing results are returned. Our batch sizes for testing are the largest in the industry that we know of to date. Dr. Chang: What do you think is the role and importance of drug compounding pharmacies in the United States? Mr. Leiter: The role of compounding drugs is paramount in the U.S. because compounding meets very tangible and very serious medical needs that cannot be met anywhere else. We can make orphan drugs, preservative-free drugs, and other drugs Source: David F. Chang, M.D. Dr. Chang: How many different ophthalmic drugs do you compound, and what sort of volumes do you generate annually? Mr. Leiter: We compound more than 1,000 different ophthalmic drugs. Our volume varies, but we have compounded more than 500 medications in a day across all various specialties. We also supply some of Leiter's is the first pharmacy in northern California to become Pharmacy Compounding Accreditation Board accredited in 2006. The non-sterile lab is shown here. Source: Chuck Leiter