Prescription Warning Label Effectiveness Found Limited

(FDA.gov)

A study by researchers at Michigan State and Kansas State universities has found warning labels on prescription drugs have limited effectiveness due in large part to their inability to get the attention of users. The results of the study appear this week in the online journal PLoS One.

The team led by Michigan State packaging professor Laura Bix used eye-tracking technology to reveal that labels on prescription drugs with warning messages, such as to take the pills with food or for external use only, are only partially successful in getting across those warnings. One of the major sources of the problem the team discovered, is that the labels — usually affixed separately from the container’s main label — do not get the attention of prescription customers.

Bix and colleagues tested the viewing of five prescription drug vials of people in two age groups: (a) 15 subjects age 20 to 29, and (b) 17 subjects age 51 to 77. The researchers found only half (50%) of all subjects looked at all of the warning labels on the vials. In fact, about 1 in 5 (22%) did not look at any of the warning labels.

More people who saw the warning labels did better at recalling the information on those labels, which suggests that enhancing the labels’ noticeability is important for remembering the warnings. However, older participants in the study were less likely than their younger counterparts to notice or remember warning labels.

The need for older drug customers to notice and heed warning labels is highlighted in a 2001 study cited by the authors that showed Americans age 65 and older take a median of five drugs with one in five older Americans (19%) taking nine or more drugs. Bix and colleagues cite more recent studies and reports indicating large proportions of patients fail to comply with the instructions received with prescription drugs.

Bix says the familiar amber drug vials have changed little in the past 50 years, and their design is ripe for an overhaul. “Our initial recommendations,” says Bix, “would be to move all of the warnings from the colored stickers to the main, white label, which 100 percent of the participants read, or to reposition the warnings so that they can be seen from this vantage point.”

Read more:

• Students Design Pill Dispenser for Visually Impaired
• FDA Issues New Label Requirements for Statins
• Standards Proposed for Prescription Drug Labels

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