As of Nov. 9, 419 cases of fungal meningitis and 32 deaths can be traced to a compound pharmacy in New England.
Today, most medications are mass-produced. A compounding pharmacy produces medications, which are custom-made for the needs of a patient.
The medications must be prescribed by a licensed physician. The compounding pharmacist follows the instructions in the prescription. Sometimes medications that are available only in a pill form may be converted to a liquid by the compounding pharmacist when patients cannot take pills due to age or medical conditions. In other occasions pharmacists may change the standard dose available by the manufacturers to better address the needs of a patient.
However, compounding pharmacists that used to produce small batches of drugs for individual patients have evolved into very large operations with a wide distribution network. The potential impact when something goes wrong can be very extensive.
Although compounding pharmacies must be licensed, they are not affected by the same regulatory constraints that apply to typical mass manufacturers. For instance, there are no federal sterility regulations for compounding pharmacies.
“Compounding pharmacies fall into a regulatory black hole,” Representative Edward Markey (D-Mass) wrote in an Oct. 8 letter addressed to Food and Drug Adminstration Commissionier Margaret Hamburg. I would expect that federal and state laws will be soon passed affecting the processing and distribution of compound pharmacists.
What went wrong in this specific outbreak of meningitis? The New England Compounding Center based in Framingham, Mass., distributed preservative-free methylprednisone (a form of steroid medication) to 23 states. Up to 14,000 people may have been exposed with fungus-contaminated spinal steroid injections. According to the Center for Disease Control four health care facilitates in California received the contaminated medication; they are located in Visalia, Encino, Ukiah and Palmdale.
These steroid drugs are injected into the epidural space in the spine to control back pain. This is a very common procedure.
Meningitis is one of the problems affecting people who received these contaminated medications. A significant percentage has also developed epidural abscesses. These are pockets of pus in the spine. Fungal meningitis is treated with antifungal medications; abscesses require not only medications but surgery to drain the purulent material.
The usual symptoms of meningitis include headaches, fever and stiffness of the neck. Additionally patients with fungal meningitis complained of dizziness and photophobia (discomfort to bright lights)
People who received these injections have been contacted; however, anyone who may have received these injections should contact a health practitioner.
An unfortunate effect of this outbreak is that some people have overreacted rejecting injections for necessary medications and immunizations. There is no reason to suspect any other injections or compounded medications.
One of the advantages of living in a modern country is the sense of security that regulations are in place to protect us from situations like this. Unfortunately, these regulatory “black holes” exposed all of us.
The same can be stated for alternative medications and dietary supplements which are not affected by the same regulations as prescription medications and it is a $20 billion industry in the U.S.
It was recently reported that the U.S. Food and Drug Administration has found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it has inspected. “It’s downright scary,” Daniel Fabricant, head of the FDA’s division of Dietary Supplement Programs, told the Chicago Tribune in the June 30 report. “At least half of industry is failing on its face.”
Editor’s note: For those interested in reading Rep. Markey’s full letter to Commissioner Hamburg, click here.