Docket Management
Docket: 00N-1637 - Advertising & Promotional Labeling for Drugs & Biologics
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. Bruce Patterson Date/Time 2000-12-24 11:29:27
Organization Sierra Medical Center
Category Health Professional

Comments for FDA General
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? Yes. Don't know practical utility
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? Don't know
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? I do not feel the proposed highlight format for drug label will be an improvement over the boxed warning format.
4. What are ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology? Don't know
5. General Comments I am a pharmacist practicing in a 200 bed hospital and consulting in a 60 bed nursing home. Regarding the proposed changes on prescription drug labeling, see, I suggest metformin warnings can be a study case in which the new format is tested. I estimate 40% of physicians make no changes in their metformin use when I advise them that the serum creatinine (Scr) is elevated. When I notice a value of 1.4 for females and 1.5 for males I advise the physician that the drug is contraindicated. In those that make no changes the response I usually get is I don't want them off the Glucophage. In one case I left a post-it note in the progress note section of the chart alerting the physician to a Scr of 1.4. Two days later the Scr was over 2 and he still continued to use metformin. I suspect they consider their judgement better than those of a warning on the drug label (package insert). Perhaps the highlight warning could cite studies which would be better explained elsewhere in the label. My main point is that the metformin serum creatinine warning can be used as a case study to evaluate the effectivness of the new format.

EC -2