The recent fungal meningitis outbreak due to contaminated compounded steroid injections have initiated an FDA investigation of the compounding facility linked to the outbreak. Steven Lynn, director of the Office of Manufacturing and Product Quality, Office of Compliance, at FDA’s Center for Drug Evaluation and Research reports that investigators observed contaminated product at the facility and “this product contamination was confirmed by FDA laboratory testing.” These observations have raised many questions about how could this fungus reached the vials of the injectable steroid which was intended to relieve surgery pain?
Many are suggesting raw ingredient contamination, but fungus contamination could have got into this batch of vials by so many means.
Unsanitary conditions, inadequate sterilization, or just irresponsible behavior by some of the pharmacy employees. These are valid reasons, after all the compounded prednisolone acetate was preservative free which means that any fungal or bacterial contamination that could have happened during the compounding process will result in a growth that can not be stopped or reversed. The result according to the FDA investigators is visual presence of fungus in many of the tested vials and confirmed microbial contamination.
Another interesting observation was the steam autoclave used to sterilize the injectable products made using non-sterile ingredients was not proven to be capable of sterilizing those products. On top of that, investigators concluded that the compounding facility could not maintain sterile environment in the clean room, as bacteria and mold were present in multiple locations of the facility including the clean room.
It is obvious that the large volume of the compounded vials could be overwhelming for a compounding pharmacy of limited production, sterilization, and testing capabilities. Clean rooms are required to follow certain rules including daily cleaning procedures and specific operational protocols and products and environmental testing. All of these are laid out in the United States Pharmacopeia (USP).
Taking into consideration the number of hospitals and private clinics used the facility to compound its needs of injectable products, vials were produced in hundreds, could have also raised the chances of contamination. The fungus according to many experts could have been in the active ingredient powder or in the solvent, further investigations are definitely needed.
Prednisone acetate is made into suspension, the process is usually time consuming and contamination could have found its way to the stock suspension during the preparation procedure.
It is clear now that the sterilization technique was inadequate to guarantee a sterile suspension and with quantities as large as the once produced of the steroid there was a higher chance of error.
Companies stopping producing certain medications due to narrow profit margins, hospitals outsourced their compounding needs to out-of-state compounding pharmacy, lack of clear regulations for compounded medications.insufficient state board of pharmacy, and other reasons mentioned above are all possible reasons for the outbreak tragedy.
Questions are still raised on how can this be averted in the future. I do not believe that the answer lies in pointing fingers of blame. It is a mutual responsibilities of every component of the health system in every country.