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Executive Summary

The point-of-purchase provides pharmacists with a "tremendous opportunity" for providing patients with drug and health information, FDA Com. Frank Young, MD/PhD, asserted May 1 at the Natl. Assn. of Chain Drug Stores (NACDS) annual meeting in Palm Beach, Fla. "A patient who is not feeling well is apt to be distracted and may not have complete recall -- hence the value of putting on the container the warning stickers we're all familiar with, or sharing any printed material that may be available on a particular medication," Young noted. The commissioner also pointed out pharmacists' ability to monitor medication through computerized recordkeeping. Young declared: "The drug store pharmacist has outstanding opportunities to obtain and communicate information, and I would urge all pharmacists to take advantage of these opportunities. The challenge before you is to demonstrate that a voluntary effort can get the job done." In his address, Young stressed the agency's current preference for voluntary and cooperative programs, such as the Natl. Council on Patient Information and Education, as first line efforts at filling public health information needs on Rx and OTC drugs. However, Young cautioned that the voluntary approach is on trial with the OTC analgesic industry's Reye's Syndrome label warning program. The labels are scheduled to appear on salicylate products this fall. "This will be a key test of voluntary compliance," Young told NACDS. "Next fall is not that far away, and concerted -- if not extraordinary -- effort will be needed to ensure that products are relabeled in time. We cannot underestimate the risk involved. If we fail, the future of voluntary compliance may be sadly compromised, and it will be difficult, if not impossible to use this regulatory approach -- which has so much to offer -- under similar circumstances again." The commissioner took the same message to the Proprietary Assn. The OTC mfrs. met the previous week. The agency's recently-proposed OTC labeling policy offers pharmacists an apportunity to provide a non-RX drug information service to patients, Young indicated. The proposed policy would create three different formats for displaying OTC drug claims and allow either FDA-approved wording or alternative language developed by mfrs. ("The Pink Sheet" April 22, p. 3).

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