Twenty people have now died from meningitis caused by contaminated steroids used in a routine procedure to relieve pain. As government agencies investigate the tainted medicine, distributed by a compounding pharmacy in Framingham, Mass., the outbreak has raised plenty of questions. And recent developments suggest the scope of the crisis may be widening. On Monday, the U.S. Food and Drug Administration reported new infections that may be linked to additional products made by the company at the center of the scandal: the New England Compounding Center.
Here are some answers:
Who is at risk?
Roughly 14,000 people, according to the Centers for Disease Control and Prevention (CDC). That's how many have received a steroid injection at any one of the 75 clinics that received contaminated steroids from the New England Compounding Center. It is not clear how many vials were contaminated among the tainted batches sent to healthcare providers, and most of the 14,000 people at risk are not expected to become sick, the CDC says. The clinics, which span 23 states, are identified on the CDC website, which also tracks the cases. The agency is currently reporting 254 cases of fungal meningitis and three instances of joint infection across 16 states. (http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html).
Anyone who received the injection in a joint, rather than by epidural, is not in danger of contracting meningitis; however, he or she may develop a joint infection.
How do I know if I got a bad dose?
You'll hear from a health official, most likely. But if you think you may be at risk, don't wait to investigate.
If you've received an epidural steroid shot since May 21, 2012, check the CDC website to see if the clinic where you were treated received contaminated doses. "If their clinic is listed, and they have not heard from anyone at the state, the CDC, or the clinic, they should contact their physician," says CDC spokesman Curtis Allen. And, of course, watch for symptoms of meningitis. "If they've had a headache—even a minor headache—fever, stiff neck, a numbness or weakness in any part of the body, or slurring of speech, they should contact their physician immediately," Allen says. "Time is of the essence. By identifying patients early, lives will be saved." Those at risk should remain "vigilant, possibly for several months," he adds. "So far, we're seeing most of the cases with an incubation period of about one to four weeks, but we're not sure of the outside limits of that incubation period."
Some 90 percent of the 14,000 people at risk have been notified that they may have received a contaminated injection as CDC, state officials, and clinic staff try to alert all potential victims.
In a briefing to reporters last week, J. Todd Weber, who is managing CDC's response to the outbreak, said the agency recommends treating those infected with two strong anti-fungal medications. He also noted the rarity of fungal meningitis and the fact that the particular fungus causing most of these infections—Exserohilum—has never before been associated with fungal meningitis. "This is new territory for public health and the clinical community," he said. Furthermore, because the fungus is difficult to detect, a negative fungal test may belie a fungal meningitis infection.
What is meningitis?
An inflammation of the membranes surrounding the brain and spinal cord. Meningitis is most often caused by viral infections, but can be caused by varied sources including bacteria, allergies, injuries, and, in this case, fungi. Fungal meningitis is not contagious.
What are compounding pharmacies? Are they held to the same standards as other pharmacies?
Pharmacies that customize medicine, adjusting format or content, for example, to meet a patient's needs.
"Compounding is a traditional part of pharmacy practice," according to the International Academy of Compounding Pharmacists, an association of more than 2,700 members. "It involves the preparation of medications on prescription by physicians and other authorized prescribers" to tailor treatments that aren't commercially available. "This might include providing different strengths, preparing a drug with different non-active excipients for which a patient may have an allergy, or creating dosage forms which are more palatable for a patient." The association says that 7,500 U.S. pharmacies specialize in "advanced compounding services," and that 1 to 3 percent of prescriptions in this country are compounded. The industry has grown to compensate for medication shortages, the association says.
Compounding pharmacies are regulated by state pharmacy boards, the Food and Drug Administration "for the integrity" of certain ingredients, and the Drug Enforcement Administration, according to the group, which says that the industry also has a Pharmacy Compounding Accreditation Board. It adds that the New England Compounding Center is not an accredited member of that board.
For its part, the FDA says it does not exercise full control over these pharmacies.
"Compounded drugs are not FDA-approved and can pose health risks when they are made using uncontrolled or poor-quality compounding practices," says Sarah Clark-Lynn of the FDA's Office of Public Affairs. "While many pharmacists are well-trained and well-equipped to compound certain medications safely, not all pharmacists have the same level of skills and equipment ... Compounded drugs that are prepared improperly pose potential health risks to the patients who take them. When such compounding occurs on a large scale, more patients are exposed to those risks."
Clark-Lynn adds, however, that "it is important to note that compounded drugs can serve an important public health need if a patient has a particular medical need that cannot be met with an FDA-approved drug."
Updated on 10/18/12: This version reflects new cases of infection.