I read with interest “Avastin Doesn’t Blind People, People Blind People.” The authors start by describing various intraocular infections that have occurred after intravitreal injection of bevacizumab. The authors review part of the intent and history of the United States Pharmacopeia (USP) chapter 797 (<797>), which was the product of several years’ work using the input of many sources, both in and out of government. This chapter provides the minimum practice and quality standards for responsibilities of compounding personnel, verification of compounding accuracy and sterilization, personnel training and evaluation, environmental quality and control, verification of automated compounding devices, and finished preparation tests for compounded drugs. Every one of these is subject to verification and documentation standards.
The article does not mention the interconnectedness of this chapter to the hundreds of other chapters in the USP and the National Formulary. It did not mention how the USP chapters are updated with supplements. The authors did not mention numerous best practice guidelines that exist to ensure quality control. Finally, the authors did not mention the ultimate regulatory functions that each state board has in monitoring the compounding of pharmaceuticals. The authors of the Perspective tidily summarize the extensive regulatory requirements as a suggestion to use a Mini-Spike Pin and an International Organization for Standardization Class 5 air quality environment. We have all had patients sold on the idea they wanted a particular cataract surgeon to perform their surgery because they heard that doctor did “laser” cataract surgery. The selection of a compounding pharmacy similarly rarely comes down to a simplistic notion of 1 or 2 pieces of equipment.
In 2005, I called various compounding pharmacies with the idea of having prepackaged bevacizumab for use in a clinic. Some of the goals were to have a convenient, safe delivery system with as little drug waste as possible. After conversations with Stephen Cosentino at Rockwell Compounding Associates, Inc (Rye, New York), we came up with the idea of putting the bevacizumab in 0.5-mL syringes with an incorporated needle. After aliquoting each batch of medication, syringes were selected at random for testing for both sterility and pyrogens. Since then, more than 440 000 of those syringes have been prepared by Rockwell Compounding in this fashion without any reported problem (verbal communication, May 30, 2012). The authors of the Perspective “strongly discouraged” the use of this method, stating that it is a “very risky proposition.” The authors supply absolutely no proof to back this claim. We performed the first review of rates of infection from ranibizumab and bevacizumab and found no difference in rates of endophthalmitis. No published study performed since has found a difference. The authors state that the syringe should have a rubber stopper instead, but do not mention the unexpected problems related to leaching components from stoppers. They also seem to ignore the significant potential for contamination caused by transferring medications from a vial to a syringe in a clinic, a practice that almost never complies with the stringent requirements placed on compounding pharmacies. While there have been lapses in enforcement of existing laws, making simplistic recommendations or labeling delivery methods as being very risky in the absence of data does not help in our ultimate goal of people helping people see.