Since October 2012, we have periodically published articles about the fungal meningitis outbreak that began at the New England Compounding Center (NECC) in Massachusetts (see our posts titled, “Fungal Meningitis Linked to Tainted Steroid Injections” and “More Compounding Pharmacies Shut Down in Fungal Meningitis Scare” for an overview both of the ailment itself and this particular story). The Centers for Disease Control and Prevention (CDC) report that there have been a total of 741 separate infection cases–including 55 deaths–spread across 20 states and that symptoms include stroke, central nervous system and joint (knee, hip, shoulder, and/or elbow) infections, headache, confusion, slurred speech, fever and nausea. Sometimes accompanying these problems is an epidural abscess, which is an infection near the site of injection (in this case, usually near the spinal column).
We wrote in January that all of these cases were thought to have originated in New England, but new evidence suggests there may have been another compounding pharmacy in Tennessee that distributed tainted injections, which would help to explain the disproportionately high number of cases in that state (a total of 152, whereas neighboring Virginia, North Carolina, South Carolina and Georgia combined have reported 75 cases). On May 24, the Food and Drug Administration (FDA) issued a press release explaining that there have been “seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy” in Newbern, Tennessee. These injections were all preservative-free methylprednisolone acetate (the same tainted drug from the NECC) and at least one of these infections has been confirmed as fungal.
Compounding pharmacies, on the whole, are usually small companies that provide pain management clinics with medicinal doses tailored to the needs of individual patients. Critics, however, argue that because there are so many specific mixtures and compounds coming out of these facilities, it is impossible for any authorities to check the purity and proper dosage of every single vial.
This new discovery suggests that the FDA and other responsible governmental bodies need to take a much closer look at the regulation and oversight of compounding pharmacies across the country. For the past few months, most attention has been focused on the New England region, particularly the Massachusetts Department of Public Health, and the failure of regulators there to adequately protect consumers. In investigations since the initial outbreak, the FDA has issued what they call “483 Forms” (notices of possible violations of the Food Drug and Cosmetic Act or other objectionable conditions) to compounding pharmacies in at least 23 states.
Recently, Commissioner of the FDA, Margaret Hamburg, has complained that many of the compounding pharmacies in question have been resistant to inspections, further delaying a proper and accurate assessment of the situation and forcing inspectors to obtain permission from the courts: “These challenges and others highlight the need for clearer authorities for [the] FDA to efficiently protect public health,” she writes in an April blog post. The problem of oversight and regulation when it comes to compounding pharmacies is not going away, and may be more widespread than many realize. Such hazards may result in injury or illness related to dangerous and/or defective drugs and as of late December over 400 lawsuits had been filed against NECC alone. With this new development, these numbers will surely grow.