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!
on Twitter @daphneallen