"The doom-and-gloom scenario is that somebody's not aware that they're receiving the same level of safety that they are with child-resistant packaging, and they leave it in that environment, and the child gets into it," Bix said. "As for tampering, in the vast majority of cases, tampering hasn't occurred, and it's not going to have an effect. But in the rare instance when a feature is missing, and the person is not aware that it's supposed to be there, and they take the drug, then you could have potentially what we had in 1982 in Chicago. Seven people died when they took Tylenol laced with cyanide. For the most part, I think products are very secure, but if something does occur, it can be very serious."
"I feel that other information on the label is more important, drug facts, for instance," Watts said. "I do think that the [newer] drug fact label is a lot better; however, I feel that the tamper feature and child-resistant feature should be a little more distinguished on the label."
The Consumer Healthcare Products Association stated that "the safe and appropriate use of OTC medicines is a top priority for the makers of OTC medicines" but that the "study's design and conclusions cannot be supported."
"Many OTC medicines have been part of numerous scientific studies on label comprehension and actual use, which inform best practices for labeling. . . . Finally, as the paper itself notes, the study is limited by the fact that we do not know participants' history with the medicine labels selected. It may well be that the consumers in the review were already familiar with the labels and product features based on use on previous occasions," the association statement said.
The U.S. Food and Drug Administration has more on over-the-counter drug product labeling.
SOURCES: Laura Bix, Ph.D., assistant professor, School of Packaging, Michigan State University, East Lansing, Mich.; Amber Watts, Pharm.D., assistant professor, pharmacy practice, Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy, Kingsville, Texas; March 27, 2009, statement, Consumer Healthcare Products Association; March 30-April 4, 2009, Proceedings of National Academy of Sciences