What pharmacists need to know about FDA's toll free number for reporting adverse events rule.

In the Federal Register of January 3, the Food & Drug Administration issued an interim final rule entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products." The new rule requires pharmacies to provide patients with a toll-free number to report adverse events.

This interim rule, mandated by the FDA Amendments Act of 2007 (FDAAA), does not apply to over-the-counter drug products approved as new drugs if the product packaging includes a manufacturer's or distributor's toll-free number for reporting complaints.

What do pharmacies need to know in order to comply with the new regulation?

• A pharmacy must distribute the side-effects statement with each prescription dispensed. The statement must be distributed with new and refill prescriptions.
• A pharmacy must choose one or more of the following options to distribute the side-effects statement: on a sticker attached to the unit package, vial, or container of the drug product; on a preprinted pharmacy prescription vial cap; on a separate sheet of paper; in consumer medication information; or as part of an FDA-approved Medication Guide.
• The side-effects statement must read: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088."
• The side-effects statement must be in a single, clear, easy-to-read type style. If the side-effects statement will be distributed on a sticker or preprinted vial cap, the letter height or type size used for the statement must be no smaller than 6 points (1 point=0.0138 inch). If distributed by separate sheet of paper, consumer medication information (CMI), or medication guide, the letter height or type size must be no smaller than 10 points.

FDA is in the process of conducting research on the wording of the side-effects statement. FDA initiated this research after reviewing the comments on the proposed rule. FDA designed a two-part study in response to these comments. The first part, which was completed, consisted of focus groups. Part two is a labeling comprehension experiment to be conducted over the Internet. FDA plans to complete this research and then, based on the results of the data collected, the agency will determine whether to finalize this interim final rule as published or to publish a final rule that amends this interim final rule.

Meanwhile, pharmacy associations expressed support for FDA's rule.

The American Pharmacists Association said, "APhA strongly supports efforts to increase active reporting of adverse events by consumers. Measures to improve post-marketing surveillance activities are a priority for the association and our members. We also appreciate the FDA's efforts to allow pharmacists time to appropriately implement this regulation."

The National Community Pharmacists Association said, "If the toll-free number can be included in the handout materials that accompany the prescriptions, it should have limited impact on our members. Now all prescriptions, whether they be new or refill, will have this requirement, which currently is not the case. That is the most important transitional aspect of implementing this rule during the next year."

The National Association of Chain Drug Stores stated, "NACDS worked closely with FDA on the impact of this rule, and we are very appreciative of the agency's sensitivity to pharmacies in complying with a measure that would impact the millions of prescriptions they fill each year for their patients. We look forward to continuing to work with the FDA over the next year to help chain pharmacies meet the requirements by next January."

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