30 people have died thus far because a drug was contaminated with essentially mold due to lack of sterile conditions at the plant where the drug was made. A fungus contaminant found in injectable steroids called preservative-free methylprednisolone acetate produced by The New England Compounding Center is believed to have infected 419 patients with meningitis and joint infections killing 30 people at last count according to the CDC. How did this happen? Do you know if the drugs your health care provider gives are safe?
What appears to be the root of the problem is The New England Compounding Center calling itself a compounding pharmacy when is reality they were acting like a drug manufacturing plant, without FDA regulation.
What is the difference between a drug manufacturing pharmacy and a compounding pharmacy?
The major difference is the FDA strictly regulates a drug manufacturing pharmacy while a compounding pharmacy is not under FDA jurisdiction. State pharmacy boards oversee compounding pharmacies but the amount of oversight varies from state to state and many are self-regulated, meaning we don’t see change until there is a problem.
Don’t throw the baby out with the bath water as some compounding pharmacies provide an incredible service. The idea of a compounding pharmacy is for the pharmacist to brew up specific treatments for individuals with a doctor’s prescription that may not be manufactured by major drug companies. This happens every day in hospital IV therapy. I have used my local compounding Kunkels Pharmacy for hormones such as testosterone, estrogen and progesterone many times and have great faith in their techniques and quality assurance. Compounding drugs are also of great use when there is shortage of medication.
Since the FDA is not regulating the pharmacies, many times the patient and the doctor do not know the quality and safety of the compounded products dispensed unless they have personally investigated their quality assurance methods like I did with my pharmacy.
The New England Compounding Center took advantage of this lack of regulation and instead of a Mom & Pop pharmacy, they set up as a drug manufacturing plant producing 17,000 units of the steroid. They are supposed to have a prescription for each one so they were most likely in violation of their state license. Many of the doctors in the 23 states that received the drug may not have realized the steroids were compounded and not strictly regulated.
Dr. Deb’s Tips for Safer Medications