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Could FDA Use Your Help in Ensuring Safe Drug Use?

November 4, 2009 – 11:37 am

FDA announced its “Safe Use Initiative that Targets Preventable Harm from Medication Use” today. The agency seems to be casting a wide net, focusing on medical errors, intentional drug misuse, misdosing, drug contamination, as well as insufficient Consumer Medication Information, which we just wrote about today.

After watching FDA Commissioner Margaret A. Hamburg launch a number of programs to boost food safety, I am pleased that she is widening her scope to include drug safety. (Perhaps medical device safety will be next? Could that be Unique Device Identification, maybe?)

Maybe U.S. Supreme Court Justice Ruth Bader Ginsburg’s own error with an over-the-counter drug spurred FDA into action?

Dr. Hamburg rightly said today: “Too many people suffer unnecessary injuries from avoidable medication misuse, errors, and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries.”

So, I sent the following questions along to FDA today:

Would the agency suggest increased use of single-use packages or unit-of-use packaging?

What about requiring that manufacturers provide risk information for dispensing with every prescription drug?

Would the use of automatic identification be urged for use on all packages?

Will any specific mandates be made in regards to packaging or labeling?

Any particular guidances?

Any other potential roles packaging or labeling can play?

I would love your input, too!

Daphne Allen
on Twitter @daphneallen

  1. 2 Responses to “Could FDA Use Your Help in Ensuring Safe Drug Use?”

  2. I am not sure that packaging and labeling can play that much larger of a role than what they already do…as it is drug manufacturers are struggling to include all the necessary information on the packaging/labeling that the FDA requires.

    They can continue to increase the amount of information they provide, but that won’t necessarily ensure that it is being read..which was the case for Ruth Bader.


    By Kim on Nov 4, 2009

  3. braille label production
    interested in developing in-line inmspection

    By mac lear on Nov 14, 2009

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