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ANESTHESIA ALERT
ANESTHETIC AGENTS
3 Ways the FDA Is Combating Drug Shortages
S
truggling to keep anesthesia drugs in stock? You're not alone. A recent
American Society of Anesthesiologists survey found 97.6% of respondents
were experiencing a shortage of at least 1 anesthesia drug. The most
reported? Fentanyl (66.3%), thiopental (43%), succinylcholne (21.1%), propofol
(19.2%) and pancuronium (15.2%).
In July, President Obama signed the Food and Drug Administration Safety
and Innovation Act. This act gave the FDA the enhanced ability to help clinicians fight against the drug shortages. Three things are now happening.
1. Regulatory discretion. The law requires drug manufacturers to report quality
issues that might affect supply when they arise. "We're getting reports daily of
'Something went wrong during process,'" says Capt. Valerie Jensen, RPh, associate director of the drug shortage program in the FDA's Center for Drug
Evaluation and Research. "If it's minor and not going to impact safety, quality or
efficacy, our drug-shortage team will assess whether it's something that can still
be sent out."
For example, one company was having an issue with glass particles in vials, so
it worked with the FDA to validate a filter to safely remove the glass. The filter
could be used on the production line, or sent out with the vials and a "dear
healthcare provider" letter. This fix kept the drug in circulation while the company and the FDA got to the root of the problem.
2. Better communication. The FDA can't require companies to make certain
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O U T PAT I E N T S U R G E R Y M A G A Z I N E O N L I N E | J A N U A R Y 2013
