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8 Closing Remarks Ruth Parker, M.D. Emory University School of Medicine Picking up a pill bottle and following the instructions for use is a patient-centered activity. It is what patients need to do; it is at the inter- section of understanding and adherence. Being patient centered is one of the hallmarks of quality. However, medication labels are complex. The whole area of provid- ing drug information is complex. Health literacy is a cross-cutting issue in drug labeling that can impact quality. Health literacy research can help figure out what needs to be done to change the labels so that the patients understand medication instructions. It would be great to see a time when patients look at their pill bottles, look at the instructions on those bottles, understand what they are supposed to do, and safely and effectively take their medications. Simplifying drug labels sounds like a simple thing, but the devil is in the details. This workshop has discussed the layers of complexity in solv- ing the problems of poor patient understanding of medication instruc- tions, but if one thinks about it, it would be pretty hard to do a worse job than we are doing today. Each person who spoke today acknowledged that there is a problem in drug labeling. Most agreed that standardiza- tion would be an improvement. As for regulation, there were some who favored that approach and others who did not. 49
50 Standardizing medication labels Courageous leadership is needed to solve the problem. Putting the patient at the center and figuring out what is best for the patient should be the unifying theme. The problems of drug labeling and patient under- standing need to be the priorityânot just putting these problems on a list, but devoting money and time to solving them. Funding is needed to collect evidence on what needs to be done. Wood showed us a system for standardizing drug labelsâthe universal medication schedule, or UMS. That was courageous leadership. Many at this conference said it would be good to obtain evidence about this approach. Obtaining evidence requires funding, but we need to be careful to identify what evidence we need. Do we really need evidence of improved adherence to move forward with a standardized drug label? That is hard to get. On the other hand, we are good at measuring comprehension. It is logical that if one cannot com- prehend the instructions on a drug label, one is most likely not to adhere to those instructions. Therefore, a good first step is evidence of improved comprehension, which we hope will then lead to improved adherence. Someone spoke today about the idea that clinical trials could use a standardized schedule for administration of medications. That is an exciting idea, and Goldhammer said it was something worth looking at. Another exciting idea is for the Department of Veterans Affairs to intro- duce a standardized label and look at the effects. Several people raised the issue of the cost of introducing a standard- ized label. We are currently spending a great deal on treating adverse drug events (ADEs), and we are going to be spending more if we do not address the current problems. Treating ADEs costs a lot, perhaps more than trying to fix the problem of drug labeling. Many today said that drug labeling is only one issue in the complexity surrounding patient understanding and use of medications. That is true. Certainly counseling, better written information, and effective transla- tions are also important. But change must start somewhere. The drug label is the primary source patients turn to for instructions on how to take their medications, so start with that. Improve the drug label. Stopping once the drug label is changed is not an option. What is done with the drug label can be used to address such issues as transla- tion into other languages. Physician and pharmacist counseling are also important components. But with a standardized label, a standard way of taking medication, patient counseling may benefit. It is time to do a better job for our patients.