The July 7 issue of New England Journal of Medicine includes an article on Trade Dress of medications, something I never gave much thought. Greene and Kesselheim discuss the concept in their article, Why Do the Same Drugs Look Different? Why do companies go to the expense of coloring their pills?
Trade dress refers to nonfunctional properties of preparations that could lead to confusion if imitated. In addition, the property must have a secondary association with the product. One example in the paper is the Coca-Cola bottle. Its unique shape does not affect the formulation or flavor of the beverage, but it is strongly associated with the drink. If a similar cola were packaged in a similar bottle, consumers could be deceived into buying an imitator.
Originally trade dress received protection to protect consumers. They would be able to tell if a substitution had been made in a drug, either for a generic or a similar but not-the-same agent (so-called palming off by pharmacies). Trade dress is serious business; Viagra will lose its patent, but "the little blue pill" is protected by law forever. Will generic sildenafil also be blue? It's hard to know; in the 1950's the "soothing" pink color of Pepto-Bismol was declared to provide "therapeutic value" so was not protected as trade dress!
So why is protection of trade dress potentially harmful? First, as patents expire, a number of bio-equivalent generic preparations become available. As pharmacies negotiate for better prices, the supplier and the appearance of the drug may change over time. The article illustrates four drastically different generic forms of the drug commonly known as Prozac. Having a drug change its appearance could confuse patients, perhaps leading to issues with treatment adherence.
Standardization of colorization and packaging could also improve patient care. For example, Synthroid (the major brand of thyroid hormone) cleverly colored each dose differently (see figure). Instead of remembering the size of the pill, patients could relate the color to confirm their dose. Exploring a couple of web sites reveals that generics also color code their doses to roughly the same shade as the Abbott product, but shapes vary.
The authors also cite an effort in the United Kingdom to standardize color of asthma inhalers. All bronchodilators became blue, while steroids were colored brown, orange, or burgundy. Patients could then be told to use the blue unit for acute attacks, and to take the other colors on a regular schedule.
Since the 1970's federal law has provided regulation of generic drug production and assurance, for the most part, of bio-equivalence with brand name pharmaceuticals. Some degree of standardization of appearance may help patients adhere to treatment plans, especially as chronic diseases requiring long-term use of multiple medications dominate the practice of medicine.
The article addresses an important but overlooked issue in the care of patients. Click on over and read the whole thing. The authors make a strong argument for legislation to promote standardization of drug appearance as well as activity.