When you ask a pharmacist what a unit-dose is you may get a funny look. Actually, you will get a funny look. I know because I asked one of the pharmacists I work with that very question today and she gave me a look that could only be described as a cross between concern and pity. She thought the answer to my question was obvious and who could blame her.
The need to define a unit-dose seems a little silly on the surface. I mean everyone knows what a unit-dose is, right ? Yes and no. It makes perfect sense when one is thinking about a tablet or capsule; one tablet is one unit-dose and one capsule is one unit-dose regardless of the strength. Unbeknownst to the manufacturers they define a unit-dose for you when they package the medication. Unfortunately that isn’t an official definition recognized by the manufacturer or the Food and Drug Administration (FDA). I know because I heard it from straight from the horses mouth during an interview with Jay Crowley of the FDA at the unSUMMIT; see my Tweet here. The issue of what a unit-dose is becomes even more confusing when you move beyond a tablet or capsule and start looking at ointments, creams, aerosols, oral liquids and even injectable medications.
My Tweet on the issue elicited a impassioned plea from Heather Leslie, MD to get some kind of agreement from the FDA on the matter. So that’s exactly what I set out to do. Following his interview I caught up with Jay as he left the unSUMMIT. Crowley is the senior advisor for patient safety at the FDA Center for Devices and Radiological Health, and he had some very interesting things to say. He was more than willing to answer my questions with what little time he had.
I asked Crowley about creating a standardized definition for unit-dose and he thought it was an idea long overdue, but reminded me ever so gently that he couldn’t do anything about it until someone forced the FDA to get involved. During his initial interview at the unSUMMIT Crowley said that the FDA makes every attempt to let things work themselves out and only gets involved when there is a “ market failure †. He recommended that I ask one of the large pharmacy organizations to get involved. I don’t know of many large pharmacy organizations, so I’m going to go with ASHP. I’ll take the recommendation for a standardized definition for unit-dose to the Pharmacy Informatics and Technology Section of ASHP and see what happens.
Comments and recommendations welcome.
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