Meningitis Outbreak Throws Spotlight on 'Compounding' Pharmacies

Raises questions about cost-cutting pressure in health care and lack of oversight, experts say

HealthDay SHARE

The steroid methylprednisolone acetate is available from large vendors that manufacture it on a large scale, Roth explained. "It's a widely available soluble type of cortisone that doesn't erode cartilage or tendons and gives a quick dosing effect," he explained.

While the reported meningitis cases have been related to patients getting spinal injections, Roth noted that injections of the drug -- if tainted -- into other joints, such as the knee, hip or shoulder, could cause troubling infections.

How could a rare fungal infection taint a drug while it is being manufactured?

The production of methylprednisolone acetate requires sterile conditions, said Dykstra. "Mold is everywhere. If the drug is not produced properly, adhering to the necessary manufacturing processes, anything is possible," he said.

According to the International Academy of Compounding Pharmacists (IACP), an industry group, about half of the 56,000 community-based pharmacies create "custom drugs" by compounding. It estimates that there are 7,500 pharmacies in the United States that specialize in advanced compounding services, with 3,000 providing sterile compounding.

The IACP said that compounding pharmacies have been typically used to create drugs when FDA-approved drug makers are unable to fulfill demand. The organization estimates that as much as 3 percent of the approximately $300 billion in prescription drugs sold in the U.S. annually are produced by compounding pharmacies.

While the FDA oversees the manufacture of pharmaceutical products, states oversee compounding pharmacies, typically through pharmacy boards.

The FDA has tried in the past to increase its role in overseeing compounding pharmacies. But it was stopped, Dykstra said, by a 2002 U.S. Supreme Court decision that struck down a portion of a 1997 law that had given the FDA the ability to develop regulations for the compounding industry.

"The FDA was up against a wall and couldn't do much after that," said Dykstra.

Dykstra said Congress now needs to act. "They need to deal with the fact that the fix they put in place in 1997 did not do the job and it paralyzed the FDA."

Some in Congress are already responding to the crisis.

"This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," Rep. Henry Waxman, (D-Calif.) and two other Democrats on the House Energy and Commerce Committee -- Diana DeGette of Colorado and Frank Pallone Jr. of New Jersey -- said in a statement.

However, Dykstra cautioned that implementing constraints on compounding pharmacies may create shortages and raise costs, at least in the short term, especially if some are shut down or avoided because of the issues raised by the meningitis outbreak.

Dykstra said people who are considering getting a spinal injection for pain relief should ask their physician specifically where the drug came from, and "maybe even see it for themselves to be sure it's from a known drug company."

Roth agreed. "A physician may not know where the drug they use is coming from," he said. "I buy methylprednisolone acetate from a big distributor. We put our trust in the manufacturer of the drug."

Roth believes there's a role for compounding pharmacies but creating this type of drug isn't it. "If it were me, I wouldn't want some pharmacy creating methylprednisolone with a mortar and a pestle going into my spine or knee. I'd want the most sterile thing available."

More information

To learn more about compounding pharmacies, visit the U.S. Food and Drug Administration.

Copyright © 2012 HealthDay. All rights reserved.