taken on the standardized label as well as fill out additional instructions needed.

The standardized prescriptions could then be translated readily onto a standard label on the prescription bottle. Patients, pharmacists, and physicians would all use the same schedule. Variability in prescription writing and transcribing would be reduced substantially, and patients’ understanding improved. It is important to note, however, that studies have not been conducted on whether patients’ adherence or outcomes would be improved with the UMS.

Additionally, if such a system were adopted, clinical trials of drugs could use UMSs in pivotal clinical trials for FDA approval. Currently, different trials may have different times when drugs are administered as long as the studies adhere to a defined schedule for administration.

A potential objection to use of the UMS is that such a schedule would cause drug concentrations in the body to vary more than would be the case if the patient took the medication at equal intervals—exactly every 8 hours, for example, or exactly every 12 hours. Wood observed that there is greater variation between approved generic drugs and their brand name counterparts than would be the case with administering drugs using the UMS since the FDA requirement for brand/generic equivalence requires only that the 90 percent confidence intervals for peak and average concentrations (AUC) must lie within 80 percent to 125 percent of those of the branded product. Furthermore, concentrations vary enormously among individuals because of biological variability and metabolizing activity. Concentrations can also vary within the same individual because of dietary intake.

In response to questions from the audience, Wood emphasized that the UMS does not remove the need to provide warnings such as can be found on auxiliary labels. It is a system for standardizing the times at which one takes medicine. There are some instances when, for example, taking the medication with certain foods or juices can vastly change the effect of the medication. For those medications, additional instructions should specify which foods to avoid.

Wood concluded that, as data presented in this workshop show, the current situation of drug labeling is unsatisfactory. Prescriptions are unclear. Transcription of a prescription to the label is imperfect. Patients frequently misunderstand the drug label. Finally, variability and complexity of labels are excessive. The potential advantages of the UMS include a simplified dosing schedule with no loss of efficiency, improved patient understanding and patient adherence, reduced errors, reduced variability, and improved therapeutic outcomes.



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