Background: Antifibrotics and antimetabolites, including 5-fluorouracil (5-FU) and mitomycin C (MMC), have been used for decades to improve ophthalmic surgical outcomes, most notably with glaucoma filtering procedures. Adjuvant MMC and 5-FU also enhance the efficacy of minimally invasive subconjunctival drainage implants now being used. The authors feel that a review of the usage and safety of these agents is merited, especially in light of updated and new USP guidelines for compounded and hazardous drugs.Main Body: The mode of perioperative administration of MMC during glaucoma surgery is evolving with a shift from the traditional sponge application to subconjunctival injection, allowing for a more precise dosing and controlled administration of this medication. Several studies demonstrate effective use of MMC and 5-FU, at a variety of different doses. Most of these studies use compounded MMC and 5-FU. Glaucoma surgeons must be careful in how they source MMC, however, as the U.S. Food & Drug Administration (FDA) expects physicians to use FDA-approved drug products when clinically appropriate. When a physician determines a compounded version of MMC is clinically necessary for an individual patient, the FDA closely regulates how and when drug products can be compounded and by what type of facilities. There will also be additional increased scrutiny on storage and disposal of MMC and 5-FU as new regulations are introduced.Conclusion: This review of MMC and 5-FU and their role in glaucoma surgery will address questions regarding drug safety, procurement, use, and disposal.
Following the devastating results of the New England Compounding Center debacle resulting from contaminated compounded steroid injections, which occurred in 2012, state and national attention focusing on the safety of compounded sterile products has continued to escalate. The Drug Quality and Security Act (DQSA) was passed, which created voluntary outsourcing facilities under section 503B as a new class of compounders regulated by the FDA. Section 503B compounding follows Current Good Manufacturing Process (cGMP) standards. FDA guidance documents addressing sterile compounding are also continuing to increase in volume and specificity. Traditional compounding efforts under DQSA section 503A remain the purview of state oversight but FDA does reserve the right to intervene at any time for quality concerns. The primary standards for 503A compounding are found in the United States Pharmacopeia (USP) Chapter <797>. These standards are currently under revision and the enhanced standards are scheduled for implementation December 2019. Typically, State Boards of Pharmacy have provided oversight and inspections on compounding but these efforts have been focused mainly on pharmacy operations. Ophthalmic compounding outside of hospital or retail pharmacy settings has gone largely unregulated. However, the revised USP <797> is intended to address all sites providing sterile compounding and eye centers performing these functions will be expected to be in full compliance with the new standards by the implementation date.
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