Drug shortages: The new norm for veterinary medicine? - DVM
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Drug shortages: The new norm for veterinary medicine?


The role of regulators

Since FDA can't require manufacturers to keep producing any particular drug, the regulatory agency is limited in ways it can mitigate drug shortages.

In the case of MNVP shortages, Peralta says FDA creates an action plan, which may include holding discussions with manufacturers and others in the animal-health industry, speeding up the animal drug-review and approval process, and exercising enforcement discretion by opting to not strictly enforce approval requirements found in the Federal Food, Drug and Cosmetic Act.

FDA has not changed any policies surrounding the management of MVNPs as a result of shortages but did respond to the problem by appointing Peralta to the position of full-time drug-shortage coordinator in January 2011.

The agency tries to keep watch and prevent shortages but says manufacturers are not required by law to notify federal regulators of impending shortages.

Even when shortages can be resolved, though, there are often problems with the price of the newly restored drug stock. Jordan says she has seen prices increase by several hundred percent after shortages are resolved.

But if a drug shortage becomes a reality, she says practitioners should contact their local veterinary medical association or veterinary college for assistance in identifying alternative suppliers in some shortage situations.

Hohenhaus also suggests taking cues from colleagues for solutions.

"When you go to meetings and (events), listen to what colleagues are saying and ask how they are handling shortages. Listen to the drug reps," she says. "Pay attention to what's out there and talk to people."


Source: DVM360 MAGAZINE,
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