October 16, 2012
The nationwide meningitis outbreak has raised questions about the safety of “compounded” medications, or ones specially made by pharmacists.
Traditionally, compounded medications have been made by small-scale community pharmacists for individual patients. Driven partly by serious drug shortages, however, some compounding pharmacies in recent years have begun large-scale production of drugs, says Michael Carome, a doctor and deputy director of the health research group at Public Citizen, an advocacy group.
The Centers for Disease Control and Prevention says the outbreak has killed 15 people and sickened 205 people, including 203 cases of meningitis, an inflammation of the lining of the brain, and two cases of joint infection.
It’s very difficult for the average patient to figure out where medications come from, unless patients fill their prescription themselves, Carome says. Doctors who prescribe a specially mixed cream may tell patients the ingredients while giving out instructions on how to use it. But hospital patients often have no way to know if they’re receiving compounded medications, such as the injectable steroids believed to be the source of the outbreak.
Even hospital doctors and nurses don’t necessarily know where their medications come from, Carome says. Often, “drugs are purchased in large quantities by a central pharmacy department, and then distributed upon a prescription or physician order to the treating provider,” he said.
Instead, patients might need to inquire at the hospital’s procurement office or pharmacy, which are generally in charge of ordering drugs, says Richard Boortz-Marx, associate professor of anesthesiology and chief of the pain division at the University of North Carolina-Chapel Hill School of Medicine.
Patients have a right to know where their medications come from, however, and to refuse any compounded medications, says William Blau, also a professor of anesthesiology at the University of North Carolina’s School of Medicine. Patients undergoing elective procedures often can safely delay treatment if needed, Boortz-Marx says.
Blau says his pain clinic gets its steroid injections from a local compounder in North Carolina. That company tests every medication and sends Blau monthly inspection reports so he can feel confident about safety. Blau says compounders have important and legitimate functions. These pharmacists might be able to get a medication in its basic form and mix it up in a way that’s not commercially available.
Carome says patients can ask to see a medication’s FDA-approved drug label. “Compounded drugs do not have to comply with the labeling requirements for a standard FDA-approved drug,” he said, adding that a sterile drug “intended for injection approved by the FDA must have a label stating that it is a sterile product.”
Quality News Today is an ASQ member benefit offering quality related news
from around the world every business day.