Eye Infections Linked to Pharmacy with History of Errors
Compounding is a process in which a pharmacy mixes medications using bulk ingredients. They are often used when a patient is allergic to inactive ingredients in commercially available and FDA-approved medications. Doctors may also use compounds when patients need alternative doses or forms of delivery than are commercially available.
Franck’s Compounding Lab has previously been investigated for pharmacy negligence when 21 polo horses died after being given a compound from the lab. The lab later admitted to using too much of a mineral in the mix, leading to the overdose. The FDA then accused the pharmacy of illegally creating copies of similar drugs. While the lab states they are compounding, the FDA argues the pharmacy is simply manufacturing commercially available medications. Furthermore, questions have been raised as to whether or not the lab is using drugs that have not been approved for use in the United States.
Now Federal health officials linked 33 cases of a rare fungal infection of the eye to products mixed in the Ocala pharmacy. According to CBS News, the victims of the eye infection had all recently had either eye surgery or eye injections. 23 of them suffered some vision loss and 24 had to have additional eye surgery as a result of the fungus. The CDC traced the cases to two products – a dye and an injection including triamcinolone. California health officials reported nine medication related infections to the CDC in March, the same month in which the lab recalled several lots of the defective dye and one of triamcinolone. The lab has not halted production of other sterile compounded products, which include chemotherapy drugs. The CDC has warned doctors against using Franck’s products labeled sterile.
In response to this outbreak, the pharmacy claims to have made several changes including hiring a new pharmacist to oversee quality and prevent further pharmacy mistakes. State health officials can neither confirm nor deny whether or not the facility is under investigation.