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More Drug Shortages in Fungal Meningitis Aftermath

Compounding Pharmacy Safety

It's impossible for a hospital running out of crucial drugs to know if a compounder is safe, says Michael Cohen, RPh, president of the Institute for Safe Medication Practices (ISMP).

"I cannot to this day clearly see anything that articulates what pharmacies are provided with the oversight to ensure that they're making these drugs safely and what pharmacies are not," Cohen testified before the FDA's September 2011 workshop on drug shortages.

A full year before the fungal meningitis outbreak, Cohen warned the panel that unsterile drugs made by compounders already had caused infections and deaths -- and that the oversight needed to prevent future disasters was "not happening."

Allen J. Vaida, PharmD, executive vice president of the ISMP, notes that compounding pharmacies are regulated by state boards of pharmacy. Those that also register as drug manufacturers, like Ameridose, are regulated by the FDA and, if they make controlled substances, by the Drug Enforcement Administration (DEA).

Many state boards of pharmacy require compounders to adhere to strict standards set by the U.S. Pharmacopeial Convention, a nonprofit scientific organization. But some do not, and states vary in how well they enforce these standards.

"With the advent of some of these compounding pharmacies getting more into the manufacturing realm -- actually making batches of pharmaceuticals, not specific patient prescriptions as is their traditional role -- they have more or less fallen through the cracks," Vaida says. "Issues now coming to light suggest there may not have been enough oversight. State boards are not equipped to do it, and the FDA is not equipped to do it on a mass basis."

Are New Laws Needed?

Drug shortages happen for many reasons. More than half occur when something goes wrong during commercial drug manufacture.

"When you're talking about a drug being sterile, you have to be 100% right, not 99% right," says Hill. "So manufacturers, if they identify a problem, they shut down the production line. And depending on how much of a drug they make, or if they are the only supplier, there is a shortage."

Drugmakers haven't always been quick to tell the FDA about such problems. That changed in October 2011, when President Obama issued an executive order requiring companies to immediately report production issues involving life-supporting drugs to the FDA.

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