The proposition of the FDA’s “Safe Use” initiative is that the way to make a drug “safer” is to better educate prescriber, dispenser, and user about the product.
At a meeting of the FDA’s Risk Communications Advisory Committee (February 26-27, 2009), there was open public comment on the issue of how to improve the written information currently provided to patients about the medicines they receive (aka “consumer medical information” or “CMI).
(PS/ per full disclosure, while I did not participate in this meeting I am a Special Government Employee consultant to this advisory committee.)
The meetings complete comments can be found here.
I found the remarks of Pam Budny, a regulatory affairs manager at Eli Lilly of particular interest.
Some extracts from her comments:
Patients should be able to locate, interpret, and act upon information in written patient labeling. It should facilitate or reinforce the communication between the patient and the prescribing and/or dispensing healthcare professional.
Patient labeling should be prepared by the sponsor just as is the case for physician labeling. Physician and patient labeling are inextricably linked in terms of the information they contain on benefits and risks.Sponsor-prepared patient labeling ensures consistency of information provided to patients in multiple venues.
For example, patient labeling received at the time the medication is dispensed would have the same content as the “full disclosure” accompanying promotional materials for patients.
Testing with patients and or caregivers prior to submission is a critical way to determine the usefulness of patient labeling prior to patient use.
Patient labeling should be developed by sponsors, tested with patients, approved by FDA, and delivered in ways that are compatible with pharmacy dispensing workflows. This information should be made available to patients each time they receive their medication.
These comments reinforce the concept of a sponsor-developed, FDA approved, “label detailing guide.” Assuming that healthcare providers both read and understand the PI is, well – wrong.
Consider the report out of the University of Chicago (a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008) indicates there is confusion among physicans about what is or is not “on-label.”
According to the abstract, the average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA-approved and greater evidence supporting efficacy for that use.
The study’s senior author, Dr. G. Caleb Alexander (assistant professor of medicine at the University of Chicago) said a concern was that off-label uses often did not have the same level of scientific scrutiny as FDA-approved uses.
All the more reason for the FDA and the pharmaceutical industry to jointly develop (as part of the agency's Safe Use initiative) better ways to make the PI more user-friendly.
The time for sponsor-created and FDA-approved label “detailing aids” is now.
“Sometimes the questions are complicated and the answers are simple.
Dr. Seuss
