Wanna’ tell the FDA about drug shortages? Here’s how

By | December 14, 2011

Here’s the contents of a email I received today from ASHP in regards to drug shortages and the FDA:

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The Food and Drug Administration Wants to Hear How Drug Shortages Impact Patients

The Food and Drug Administration has opened a comment period to gain insight about the causes and impact of drug shortages. The agency is seeking feedback as a follow up to a public workshop on the impact of shortages.

You know first-hand the devastating effect that drug shortages are having on patient care.  Today, ASHP’s Drug Shortages Resource Center lists 208 shortages. That’s nearly the same number of shortages that were reported in all of 2010.

This is your chance to speak up.

Write a letter to the FDA that describes your experiences and challenges managing drug shortages.  Here’s what you should include:

  • Impact on patient care.  Share examples from your practice site, such as patients who’ve had to delay care or who’ve experienced adverse affects from second-line therapies.

  • Impact on pharmacy department operations: Discuss how the time spent researching availability of drug products and the redeployment of pharmacists from patient care roles affects the pharmacy department.

Be sure to ask your colleagues in the pharmacy department as well as your nursing and physician colleagues to join you. Enlist your patients as well. Every voice counts!

The deadline to submit comments is December 23, 2011. You can post comments on www.regulations.gov or send comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852.  See the Federal Register notice for more details.

Your input and expertise are not only welcome, they are essential to achieving a solution to this critical issue.

Use the resources below to familiarize yourself with ASHP’s messages on drug shortages.

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