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Labels on OTC Painkillers Need Improvement
Date:3/30/2009

Study found safety warnings for kids were missed, could be more prominent

MONDAY, March 30 (HealthDay News) -- When Laura Bix brought home a bottle of over-the-counter pain relievers recently, she was surprised to find that the bottle did not have a child-resistant cap on it.

Bix, the mother of three small children and an assistant professor in the School of Packaging at Michigan State University, knew that one size of any product line can be exempted from the federal requirement for child-resistant closure as long as the warning is "conspicuous" and "prominent" on the label. However, this was not the case with the painkillers Bix had bought.

"I thought, 'I'm bringing it into my house, so probably others are bringing it in as well,' " she said.

So, Bix conducted a study, published in this week's issue of the Proceedings of the National Academy of Sciences, to see if consumers were seeing and/or remembering these warnings.

"Child-resistant labeling is really important, because children sometimes feel that medicine is candy, and they run the risk of taking medication and overdosing," explained Amber Watts, an assistant professor of pharmacy practice at Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy in Kingsville, Texas. "A lot of times, medication should not be consumed by children, especially those less than 6."

In fact, manufacturers of over-the-counter cough-and-cold medicines recently agreed to stop marketing these products to children under 4.

In the Michigan State study, 61 participants were asked to look at the packages of five over-the-counter pain relievers and were monitored with eye-tracking devices to pinpoint what they were looking at and for how long. Individuals were given 10 seconds to review the label.

"Most people spend five to seven seconds viewing things before making purchasing decisions, so we felt that this was conservative," Bix explained.

Participants spent the most time scanning the brand name.

More than 80 percent of volunteers didn't look at the tamper-evident warning. More than 50 percent didn't view the child-resistant section.

Warning labels were recalled the least, from 0 percent to 18 percent (tamper-evident information was not mentioned by any one). Brand name, indications and package color were the most likely to be recalled. Two-thirds remembered the brand name, and 40 percent could remember the color.

The child-resistant and tamper-evident warnings were also found to be less legible than other sections of the packaging. There was some indication that people with children found the labels less legible, although this may be because those with children were older than those without (average age of participants was 25).

"This basically points out that labels may not be conveying the information that we would like them to," Bix said. "Are there things we could do to make them more noticeable or is the consumer just not taking this information seriously and not taking the time to think it out. Depending on where the failure occurs, I think the solutions are very different."

Although the likelihood that anything would happen by having a non-child-resistant bottle in a household with children is slim, Bix nevertheless took the bottle she had purchased to her office.

"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.

More information

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


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