This case involves a compounding pharmacy that allegedly used insulin syringes to fill in an anti-cancer drug used off-label to treat eye conditions, including macular degeneration. The syringes were lubricated with silicone oil and not designed to be used for eye injections. However, they were allegedly sold to ophthalmologists for the treatment of macular degeneration. The silicone oil contamination resulted in silicone oil deposit in the eyes. This caused vision interference for patients who took the medication, and many required corrective laser surgery or a vitrectomy.
Question(s) For Expert Witness
- 1. What is the role of the compounding pharmacist in selecting the type of syringe used for filling in a drug?
- 2. Are you familiar or involved with USP regulations with compounding solutions?
Expert Witness Response E-163492
I am a member of the USP Compounding Expert Committee and I served as the USP Council of Experts Sterile Compounding Committee Chair for 10 years. I have compounded many injections and a few ophthalmics as a civilian and US Army hospital pharmacist as well as a university faculty member. To comply with US Pharmacopeia General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, i.e., USP 797, compounders are responsible to ensure that containers (e.g., ampules, syringes, and vials) maintain sterility, strength, purity, and stability of compounded sterile preparations, i.e., CSPs. I have consulted on several cases of patient harm and death from pharmacy compounded CSPs, including for the US DOJ.