a “no food” symbol on a prescription bottle looks like. What will cause the situation to change?

Ostrove responded that these are issues of implementation and raise the overall question of whether the introduction of standards should be a grassroots approach or whether it should be through legislation and regulation. Even if one were to implement regulations, it does not mean that practice will conform, as seen from research that shows mandated medication guides are not distributed. Brach responded that from the perspective of a non-regulatory federal agency, there are options short of regulation, such as working with relevant associations and organizations. If there is sufficient evidence to support standardization, then one could bring relevant groups together to develop an implementation strategy. Such groups might include the Department of Health and Human Services, private-sector partners from relevant associations (e.g., from pharmacy and medicine), and the IOM Roundtable on Health Literacy.

The panel was then asked whether the expanding use of electronic medical records presents any additional regulatory or legislative possibilities or issues. Brach responded that, to her knowledge, there are no prohibitions to such legislation or regulation. Currently there are a number of systems operating. The Department of Health and Human Services is engaged in trying to reach a consensus about interoperability among the many vendors of the systems that do exist, but it is not pursuing regulation in this area. Torrise agreed that there is probably nothing that would prevent such regulation, but there are disincentives.

Panelists were then asked if each would state who should take leadership on moving forward on the issue of drug label standardization. Torrise stated that since the VA is, in effect, its own state board of pharmacy, it can write the necessary policies for its system. Furthermore, the VA will be closely examining the issue of standardization to determine how to move forward in this area. Brach suggested that the implementation issues are beyond the purview of one federal agency and, instead, require the cooperation of all those involved. From the AHRQ perspective, Brach stated, one needs to determine how drug label standardization would be integrated into the overall strategies of improving other pieces of the system, such as patient counseling, since merely standardizing drug labeling would not fix the problems of medication safety and adherence.

Ostrove agreed with Brach and further pointed out that there is as yet no information on the impact of such standardization on patient adherence. Until that is available, the best that can be done is to develop a theoretical marketing plan for the idea. Groups that could be instrumental in moving forward with this include the IOM, working very closely with the pharmacy industry and the NABP.



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