CHPA Supports FDA’s Proposed Regulation on Bar Codes

Protecting America’s Patients from Human Error Is Divine

Washington, D.C. (March 17, 2003)—The Consumer Healthcare Products Association (CHPA) supports the U.S. Food and Drug Administration’s (FDA’s) proposed regulation that would require adding a bar code to medications intended to be dispensed in hospitals in single-unit packaging. According to the proposal, these codes would arm busy healthcare professionals with modern technology that would help them avoid making crucial medication mix-ups and mistakes. While the Agency’s requirement would obviously have the greatest impact on prescription drugs, over-the-counter (OTC) medicines intended to be used in institutional settings would also be affected.

“FDA should be congratulated for developing an initiative that adds an extra layer of protection for patients,” said CHPA President Linda A. Suydam. D.P.A. “CHPA and its members believe this effort will greatly reduce unnecessary human errors and provide both health professionals and the people they treat with better peace of mind.”

The Association has participated in a number of meetings with FDA over the past several months on this issue. The trade group indicated in previous comments to the Agency that while it backed the use of bar coding on OTC packaging to prevent mistakes with products used in hospital and institutional settings, it did not make sense for the broader consumer arena. CHPA will also be commenting on particular aspects of the proposed rule to assure that it maintains efficiencies in OTC distribution.

“We firmly believe that labeling is still the most appropriate tool to prevent medication errors among consumers who use OTC products,” said Suydam. “As always, consumers must be sure to read and carefully follow the instructions on OTC labels and to address any questions or concerns to a healthcare professional.”

Contacts: Donna Edenhart and Mimi Pappas, 202.429.9260

CHPA is the 122-year-old trade association representing U.S. manufacturers and distributors of overthe- counter medicines and nutritional supplement products.