In theory, compounding pharmacies serve an important role in health care. CP's can manufacture medications in small batches that are withdrawn from production by major pharmaceutical companies, but still are needed by patients. These companies can formulate a medication using an approved active ingredient without ingredients that will cause adverse reactions in certain patients. Or they can put the ingredient in delivery systems that are more appropriate to the patient. Ffor example, a liquid form for children or a different flavor for veterinary use.
CP's are regulated and inspected only at the state level, so these medications are supposed to only use approved ingredients, be prescribed for the appropriate conditions, and stay within their states of manufacture,.
But in practice however, these pharmacies are not always adhering to their limitations or practicing their business safely and responsibly.
Exserohilum rostratum is a fungus that usually infects plants, although sometimes enters the human body through a wound, causing surface irritations. Injecting it into the spine, or elsewhere in the body though, puts it into a completely different environment. Employees at the New England Compounding Center tracked this fungus in from outdoors on their shoes and clothes because they were not required to change or cover up when they entered the manufacturing area. The center worsened the situation by turning off indoor climate control and failing to observe other basic sterile procedures.
Back in 2002, there was a similar outbreak at the NECC, stemming from the lax environmental conditions. The contamination was smaller. According to MedPageToday, "The outbreak has been linked to injections of a steroid, preservative-free methylprednisolone acetate, that was contaminated with E. rostratum." The medications voriconazole and liposomal amphotericin B are now being recommended by the CDC, to treat such an outbreak. This is small comfort however to the families of the 30 people who died from the infected medication. Hopefully it will be of some help to over 400 people who have developed spinal meningitis, arachnoiditis, or abcesses at injection sites from tainted steroids.
This is not the first time the NECC has been under scrutiny by the FDA. Staffers reported problems to the state regulatory agency and to the FDA, but the State of Massachusetts did not correct the problem, and the FDA was not permitted to intervene until there had been a serious health incident.
In 1996, David Kessler, commissioner of the FDA, pushed for FDA oversight after already having seen numerous adverse events result from the unregulated industry. However, the International Academy of Compounding Pharmacists lobbied hard to keep their autonomy, and the pharmaceutical industry, unaffected by the existence of CP's, declined to give its voice in favor of regulation. Even the restriction on keeping state-regulated CP's from shipping their product across state lines never made it into law.
Because the FDA does not regulate compounding pharmacies, the only thing the federal government can do is provide guidance information and issue compliance letters and warnings after a compounded medication has been found to be unsafe. Now that the number of people infected with fungal meningitis from the NECC has grown and spread across 19 states, the FDA is able to press its case for regulation.
And finally, in Massachusetts at least, the Pharmacy Board (which was supposed to make sure this kind of thing didn’t happen in the first place) is proposing changes in regulation that should be ready to be recommended to the state legislature by December 31for debate, and perhaps even some day, approval. This will have to be done state by state, and if the pattern persists, it will happen only as each state comes under scrutiny for its CP's violating guidelines and shipping out medications that hurt people.
The good news is that if you got sick or died from their products, the NECC is offering a full refund. All you have to do is fill out this form and they’ll cut you a check.