Drug Shortages: New Ones Down, Old Ones Persist

By David Pittman, Washington Correspondent, MedPage Toda

WASHINGTON -- The number of new drugs added to the shortage list has fallen off sharply in the last year, but those already on the list show few signs of moving off, according to the University of Utah Drug Information Service.

The system has tracked just 86 new shortages through July 31 this year, down from 204 in all of last year, 267 in 2011, and 211 in 2010. However, the number of active shortages as of the end of July was 302 -- roughly what it has been since the third quarter of 2012.

Existing shortages continue to be a problem "because it is taking a long time for the companies to fix their [manufacturing] quality problems" that cause the shortages, Erin Fox, PharmD, director of the Utah center, told MedPage Today.

Shortages of antimicrobials, chemotherapy agents, and electrolyte and parenteral nutrition products -- such as sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride -- continue to be a problem, Fox said.

The FDA has declined to release updated information on the 2013 drug shortages until the new calendar year, spokesman Stephen King told MedPage Today. He added that the FDA successfully prevented 282 shortages last year.

King and Fox said changes included in last year's FDA Safety and Innovation Act (FDASIA)that require manufacturers to alert the agency to possible shortages in "life-supporting" or "life-sustaining" drugs are helping. The FDA is able to prevent many new shortages from occurring, the two said.

"However, there is nothing in FDASIA that makes the manufacturers devote more resources to quality or to generic products over brand products, so the shortages that we have are persisting until the factories are updated," Fox said.

Quality control is a major cause of shortages, particularly of generic products. Production issues -- such as glass particles or other particulates found in products -- have caused some of the already small handful of sterile injectable manufacturers to shut down.

In the case of IV electrolytes, the shortages are occurring because one manufacturer -- American Regent in Shirley, N.Y. -- ran into production troubles and had to shut down entirely.

Fox noted that a July 23 decision in the Court of Appeals for the District of Columbia Circuit could hurt FDA efforts to alleviate drug shortages. The 3-judge panel permanently enjoined the FDA from allowing imported versions of thiopental -- a drug used in executions -- into interstate commerce.

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