Progress made on drug shortages although manufacturing issues persist

August 28, 2015

While the rate of new drug shortages has fallen, manufacturing problems and FDA import bans continue to cause shortages of certain medications in U.S. hospitals.

While the rate of new drug shortages has fallen, manufacturing problems and FDA import bans continue to cause shortages of certain medications in U.S. hospitals.

See also: Generic shortages complicate pharmacists’ duties

Erin Fox, PharmD, FASHPErin Fox, PharmD, FASHP, director of Drug Information at the University of Utah Health Care and adjunct associate professor at the Department of Pharmacotherapy, University of Utah College of Pharmacy, discussed the problems and ongoing challenges relating to drug shortages during last week’s Wolters Kluwer Clinical Drug Information webinar.

The University of Utah Drug Information Service provides content for the ASHP Drug Shortage Resource Center, and Fox has led the drug shortages project since the beginning of the partnership in 2001.

New drug shortages on the decline

See also: Drug shortages on the decline

For the first half of 2015, 68 new drug shortages have been reported, compared to 185 in 2014.

“The rate of new shortages has decreased and the long-term, active and ongoing shortages are beginning to resolve, but we still have shortages of the basics like antibiotics,” Fox said.

In addition, it is “really difficult to have shortages of basic products like fluids,” Fox said. “It is a manufacturing failure that is not meeting clinicians’ needs. Fluid shortages have affected every patient.”

 

FDA’s efforts to prevent shortages

The FDA has made some positive steps to prevent or curb drug shortages, including allowing products to stay on the market that would normally be recalled. For example, at the height of last year’s electrolyte shortages, the agency asked physicians to filter solutions that might contain particles, instead of recalling some contaminated solutions.

The FDA can also ask manufacturers to ramp up production, or speed up approval of a new product that is in short supply. The agency can also grant special permission of imports, such as when it allowed imports of propofol and saline during the height of the shortages.

Pharmaceutical manufacturers are also making some efforts to reduce drug shortages. The International Society for Pharmaceutical Engineering has been working with manufacturers on shortages prevention plans since early 2013. “Their surveys found that a lot of the shortages were due to quality problems and keeping the manufacturing process sterile, so they worked towards having a higher quality production process and metrics,” she said.

The FDA also recently created the Office of Pharmaceutical Quality to ensure that drugs are safe for consumers and has released a draft guidance on quality metrics for drug manufacturers. “The goals include modernizing the drug quality oversight that FDA does,” Fox said.

Still, pharmacies need transparency in the drug manufacturing process. “The U.S. labeling law does not require suppliers to disclose who manufactures their products, and there is no requirement to disclose the location of where the product is made,” Fox said. “If we knew [from FDA warning letters] that the factory in a certain city was causing certain problems, we might make a different decision on which product to buy.”