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The CDC, most medical journals, and mainstream media have been covering the disastrous infections caused by the contamination of the steroid that was distributed by a compounding pharmacy in New England. Three potentially contaminated lots of this steroid were used by physicians in epidurals, and joint injections in over 14,000 persons. They have, so far, caused stroke, meningitis, bone infections and in some instances death, in over 137 patients.

The initial detection of this serious contamination reads like a detective story. On September 18, 2012 the Tennessee Department of Health was alerted by an observant physician that a patient had a confirmed fungal infection (to be exact, Aspergillus fumigatus) diagnosed 46 days after epidural steroid injection. By September 27, an investigation carried out by the Tennessee Department, in collaboration with the CDC and the North Carolina Department of Health, had identified 8 more cases. All nine patients had received epidural steroid injections with preservative free methyl prednisone acetate solution (MPA) compounded at the New England Compounding in Framingham, Massachusetts. And as of October 10 (when last reported in JAMA) a multistage investigation by the CDC together with local health departments and the FDA have identified 137 cases and 12 deaths associated with this outbreak in 10 states. The invoices from the pharmacy showed that approximately 17,500 vials of MPA were distributed to 75 facilities in 23 states!  By October 6, the vials not already used were recalled. And as of October 10, health departments reported that 90% of patients exposed to the medication from one of the suspected infected lots of MPA had been contacted at least once.

The patients and their doctors have been advised that they should get tested if they develop neurological symptoms such as headache, neck rigidity, fever, nausea, unsteady gait or sensitivity to light…and if so a lumbar puncture should be done to check for the fungal infection. Those patients that had joint injections should notify their physician if they develop increasing pain, redness or swelling, in which case fluid should be aspirated from the affected joint for culture. This all sounds ominous and in fact it is! Right now it’s postulated that the incubation periods for infection range from 4 to 42 days, but the maximum incubation for this infection is not known. Treatment with high dose anti-fungal therapy for months may be necessary.

If anyone doubts the importance of the epidemiological sleuthing carried out by our health departments and the CDC…this should dissuade them. And additionally, there is the issue as to whether products from compounding pharmacies are indeed safe. In an article published on December 6 in The New England Journal of Medicine, the authors summarized the evidence for compounding safety…. First, they explain what these pharmacies do: “Pharmaceutical compounding refers to the combining, mixing, or altering of ingredients of a drug by a licensed pharmacist to produce a drug that is tailored to an individual patient’s medical needs on the basis of a valid prescription from a licensed medical practitioner.” They go on to state that ” there are few reliable data on the prevalence of compounding, but it has been estimated that 0.25% to more than 2% of dispensed  prescriptions in the United States are compounded drugs. Under certain conditions, compounding may serve an important public health benefit by providing access to the needs of individual patients when a commercially available product is unavailable; however, compounded drugs are not approved by the FDA and should not be confused with generic drugs all of which must be approved by the FDA before marketing. Compounded drugs are not reviewed and approved by the FDA; therefore, their safety, efficacy, quality and conformance with federal manufacturing standards have not been established…. The regulatory authority of the FDA over compounding pharmacies is different and more limited than is its authority over pharmaceutical manufacturers.”

 

Bottom line: Thank you to the FDA and CDC. Even though regulations can be burdensome and costly they are worth it; they protect the purity and sterility of our medications. And if I do prescribe a compounded medication, I tell the patient and request that she fill the prescription in a closely monitored pharmacy.

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