Meningitis Outbreak Leads To Examination of Compounding Pharmacies
Nov 15, 2012
There are currently at least 184 cases of meningitis in the U.S., including 14 fatalities, confirmed by the Center for Disease Control. The fungal meningitis outbreak started when steroid medication was contaminated with a fungus and the fungus was injected into the bloodstream when the shots were administered to patients. Infection has been recorded in numerous states, including Florida, Indiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Ohio, Tennessee, Texas and Virginia and numbers are expected to increase: the incubation period can take as long as three months.
According to Dr. Ilisa Bernstein, the acting director of the FDA’s Center for Drug Evaluation and Research Office of Compliance, the FDA is examining the way compounding pharmacies are monitored for safety. A compounding pharmacist customizes medication as needed to fit each individual’s need; if a dosage is too large or needs to be delivered without dyes, for example, the pharmacist can combine medications, or “compound” them. Compounding, or combining different items to make a specialty medication, was the standard way all medications were manufactured until the 1950s, when mass production became the norm.
Pharmacies like The New England Compounding Center may compound medications for specific prescriptions, and are usually supervised by that state’s pharmacy boards. The New England Compounding Center has been in the spotlight previously: the FDA looked at their compounding practices in 2006 and stated that the firm’s actions were inconsistent in its compounding practices and acted more like a drug manufacturer.
While compounding production is legally restricted to individual prescriptions, the pharmacy may have mass produced the compounding production, which is why such a large batch was contaminated. The New England Compounding Center where the medication was compounded has recalled more than 17,000 vials of the injectable steroid treatment used for back and joint pain. The fungi which has tainted the steroid includes Aspergillus fumigatus and Exserohilum, and are often found in grass, leaf mold, grass, and old wood.
At this time, it is believed that as many as 14,000 people received the contaminated steroid injections. Some 90 percent of those individuals have been contacted. Multiple investigations are ongoing and Connecticut’s Sen. Richard Blumenthal of Connecticut has called for a criminal investigation into the company.
Symptoms of meningitis include fever, headache, and nausea. An infection of the membranes which cover the brain and spinal cord, fungal meningitis must be treated in a timely fashion. It is not contagious.