According to the Centers for Disease Control, as of to-date, 105 people have been sickened in the national meningitis outbreak, which was caused by a batch of fungus-tainted steroid shots used to treat back pain. The death toll has climbed to nine, while health officials warn that as many as 13,000 people who received the shots may be at risk.
Over 17,000 of the single-dose vials of the steroid, prepared by the New England Compounding Center, were distributed among 23 states. Suspicion over the sterility of the vials was first raised last month when a patient in Tennessee developed the rare fungal meningitis following injection of the steroid.
Though the compounding center responsible for its manufacture has since issued a recall and surrendered its state license to operate, the outbreak is forcing health officials to question the safety and lax regulatory standards of such drug-mixing pharmacies.
While compounding drugs can serve a vital need by providing medications that are otherwise unavailable, the practice has since shifted from hospitals to outside pharmacies, as the process required to make them grew more complex. In 2000, there were virtually no compounding pharmacies in the U.S., but now about 3,000 exist, accounting for 3 percent of the $300 billion yearly U.S. prescription drug market. And though state pharmacy boards license these pharmacies, they are not regulated as strictly as regular drug makers.
The Pharmacy Compounding Accreditation Board does provide additional quality assurance recognitions, but only 162 U.S. compounding pharmacies have received such an accreditation about 6 percent of all compounding pharmacies.
Aside from the recent meningitis outbreak, compounding pharmacies have been linked to contamination and illness in the past as well. For instance, last year in Alabama, contaminated IV bags obtained from a compounding pharmacy caused nine deaths and 10 illnesses.
The whole concept does indeed shock the conscience, says ACSH s Dr. Gilbert Ross. Though these are just a few isolated instances, it does draw attention to the practice in general, which should be subject to greater quality control and safety regulations.
