Patients have few ways to learn source of medications

• Hospital often use compounded medications made by pharmacists, not factories
• Even hospital doctors, nurses may not know if a medication was made by a compounder
• Patients can ask to see a drug's FDA-approved label

The nationwide meningitis outbreak has raised questions about the safety of "compounded" medications, or ones specially made by pharmacists, rather than large-scale factories.

Yet patients often have no way to know if they're receiving compounded medications from a hospital or clinic, doctors say.

The Centers for Disease Control and Prevention has linked the meningitis outbreak — which has sickened 185 people in 12 states, causing 14 deaths — to injectable steroids that were recalled by the New England Compounding Center, a Massachusetts pharmacy. As many as 14,000 patients were treated with the steroids, largely used to treat lower back pain but also injected for joint pain in the knee.

The outbreak has called attention to gaps in the nation's system for inspecting and regulating drugs, says Michael Carome, a doctor and deputy director of the health research group at Public Citizen, an advocacy group.

Although the Food and Drug Administration inspects large factories, it leaves state pharmacy boards to monitor pharmacists who mix their own medications.

It's very difficult for the average patient to figure out where their medications come from, unless patients fill the prescription themselves, Carome says. Doctors who prescribe a specially mixed cream, for example, will often tell patients the ingredients while giving out instructions on how to use it.

Learning the source of an injectable drug given in a hospital or clinic may be far harder. "The patient likely has no idea where the drug came from," Carome says. "Many patients probably don't even know what a compounded drug or compounding pharmacy is."

William Schaffner, an infectious-disease expert and professor at the Vanderbilt University School of Medicine in Nashville, says he can't recall a single time that a patient has ever even asked where a medication came from.

"I don't think that any patients receiving medicine for any reason has ever asked, 'Where did you get that medication?' " Schaffner says. "They expect the medication will be safe. That is a reasonable expectation."

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."

Richard Boortz-Marx, associate professor of anesthesiology and chief of the pain division at the University of North Carolina-Chapel Hill School of Medicine, says doctors may not be able to answer patients' questions.

"Probably most physicians have little if any idea as to where their supply of medications are coming from or manufactured by, unless it is on the particular vial, in which case they may be able to answer," Boortz-Marx says.

Instead, patients might have to inquire at the hospital's procurement office or pharmacy, which are generally in charge of ordering drugs, Boortz-Marx says.

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.

While the vast majority of hospital drugs are made by large pharmaceutical companies, Blau says others are only available from compounders. Blau says his hospital uses some medications from a local compounder in North Carolina. But that company tests every medication and sends Blau monthly inspection reports, so that he can feel confident about safety. His clinic does not get its injectable steroids from a compounder.

Blau say compounders have important and legitimate functions.

Compounders have become more important in recent year because of massive drug shortages. Compounders also sometimes can make drugs more cheaply, Blau says.

While patients who need emergency care are unlikely to ask where their drugs come from, those undergoing elective procedures often have the time to ask, and even delay a procedure if necessary, Boortz-Marx says.

For patients with chronic pain, "epidural steroid injections are elective procedures, and until the patient has the necessary information they require to make an informed decision, I would recommend they place the procedure on hold," Boortz-Marx says. "Their physician should be understanding and supportive of such a choice."

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," Carome says. "Thus, the risks of the drug are frequently not disclosed and instructions for safe use are not provided.

A sterile drug "intended for injection approved by the FDA must have a label stating that it is a sterile product." Carome says.

Doctors should never inject a drug that isn't specifically labeled as sterile, Carome says.