Readability of The Fine Print

How do you determine the value of a written word? Well many of us have learned the hard way that the little words in fine print that we didn’t pay attention to, actually had far more intrinsic value than we were willing to give them credit for. However, governmental agencies and pharmaceutical companies have some insight into the value of “little words”, a.k.a. imprints, and for some time now, have believed that we will take notice.

In 1980, Washington State mandated the use of imprints on all prescription drugs and on all OTC’s in 1991. The FDA followed suite in 1995, through their implementation of the federal requirements for imprints. Imprints have become defined in 21 CFR 206 10(d) as:

Imprints are found in all shapes and sizes and are either pressed into or directly printed onto tablets or capsules. The most common methods of applying imprints is through the use of a mechanical embossing process or through a surface printing method. However, both contact methods can damage or crack products, which results in product rejects.

The move towards using a non-contact printing method, such as ink-jet, has reduced the damaging of products; however, now print quality is a concern. Specifically, the spreading of the ink droplets or the slow drying of the ink reduces the print quality and readability of imprints. As much as there has been technological progress in the quality of ink-jet printers, and the use of fast drying inks have become common place, printing errors still occur.

Just how important is the quality and readability of ink imprint on drugs? The fact that imprints are used as medication identification features by health care professionals and patients, it is clear that readable imprints play a significant role in reducing medication errors. Furthermore, the U.S. Pharmacopeia has alerted the public that any inconsistencies in the quality of an imprint maybe a sign of product tampering or drug counterfeiting. Therefore, accurate visual verification of imprints is not an option, but a necessity.

Who benefits from clearly readable imprints? The obvious benefactors are the end users. The reading of imprints has been described as an unbiased way for medical personnel to identify and differentiate between drugs. Furthermore, imprints allow patients to easily identify drugs for refills, and therefore, patients are able to take a more active role in the managing of their medications. The main benefit gained from these examples is obvious: reduction in medication errors. However, pharmaceutical companies also benefit since clearly readable imprints create avenues for product branding.

In the end, those “little words”provide valuable benefits to pharmaceutical companies, medical personnel and end-users, but only if they are clearly readable.