Today is the final day for comments on California’s new prescription drug labeling requirements aimed to boost patient safety. Don’t worry–they appear to target pharmacy-generated labels, not manufacturer-generated labeling–but I wonder how they ultimately could influence your labeling.
The new rule drives a number of changes that would result in what is called “a patient-centered label.” What intrigues me most (today) is the debate over font size. Early language lists the minimum font size at 12 points, but the California State Board of Pharmacy changed the proposed minimum to 10 points and then added a clause that 12 points are to be used if the consumer requests it.
The State Board of Pharmacy had received several letters from senior citizens, their advocates, and others objecting to the 10-point minimum. Another comment period was announced, concluding today. (For details, visit the board’s regulation page.)
To read some of the past comments, visit the board’s April meeting page and read all the attachments under “1707.5 Patient-Centered Prescription Labels.” There’s a lot of passion in these letters. For instance, Gary Taylor wrote: “Confusing or hard-to-read prescription labels pose a major threat to the safety of patients, especially seniors and others with limited eyesight. We need safer, clearer labels to help prevent deadly errors.” In conclusion, he wrote: “Requiring a 12-point font on the most important parts of medication labels is a small step that will save lives. I urge the Board to return to its initial recommendation and vote for stronger prescription label standards for Californians.”
Steven Wallace, PhD, Professor and Vice-Chair, Dept. Community Health Sciences, UCLA School of Public Health, is optimistic that technology can deliver the 12-point font. “While some bottles and packaging may be small, there are a number of innovative ways to attach labels that are large enough to support 12 point type with key information.”
How does this affect you, a packaging professional at a pharmaceutical or medical device manufacturer? In terms of current regulations, very little, I imagine. But if labeling font size truly influences patient comprehension, as these letter writers stressed, you may want to look at your own labeling, especially if you are intending some of it for patients.
Yes, 12-point font size is large, especially when you compare it with FDA’s minimum font size of 6 points for Drug Facts labeling text for over-the-counter drugs.
But I wonder what FDA may think now. Interestingly, in its “Strategic Plan for Risk Communication,” FDA writes: “Clear and easily understood information on prescription drug labels and instructions for use, as well as extra efforts to target specific identified problems and populations, can help ensure appropriate and safe use. For example, if particular drugs are more likely to be used by elderly people, considering carefully that group’s cognitive limitations could lead to instructions for use that are more likely to be followed.”
Could California’s influence over pharmaceutical labeling soon be felt even more?