which is a highly collaborative effort involving teams of physicians, pharmacists, nurses, diabetes educators, and patients. Such research will help identify best practices, which are to be preferred over a regulatory approach.

While regulation is not favored as the primary approach to solve drug labeling problems, there may be some role for regulation. For example, the NABP plays an important role in developing model regulations for review and use by the 50 state boards of pharmacy. In moving forward to address the kinds of issues raised here, thought could be given to a national collaboration that would examine how to implement some of the best practices we know exist. There are numerous stakeholders that should participate in such an effort, many of whom have already been identified. Although it is important to hold discussions of how to proceed, action is also necessary.

DISCUSSION

One participant asked, since those on the panel appear to favor moving forward with standardization and the recommendations in the ACP Foundation white paper, who should lead that effort? Goldhammer responded that the leader should come from the field of pharmacy. Townzen suggested that the NCPDP would be an appropriate leader. That organization has been identified by the Consolidated Health Initiative as an appropriate group for establishing standards. Furthermore, the NCPDP has devised a standardized prescription card to address some of the variation in state requirements. McEvoy agreed that the NCPDP is a key participant and reiterated what he stated during his presentation, that is, that the other groups that should be involved include the AMIA, USP, the Joint Commission, HL7, and the IOM. McEvoy also suggested that one might wish to have a neutral convener for this effort, perhaps a new consortium of groups. Ellis responded that medicine and pharmacy practitioner organizations should begin the process but that other stakeholders should be involved.

Panelists were asked whether there are business or competitive issues (other than costs of implementation) to consider that might create barriers to implementation if efforts to standardize labels resulted in minimizing pharmacy logos. Ellis and Townzen agreed that the effect of minimizing the pharmacy logo is probably minimal and should not impede implementation.

Another questioner asked whether clinical trials could be designed around a standard medication administration schedule and, if so, whether pharmaceutical manufacturers could take the lead on that restructuring. Goldhammer responded that it seems possible to structure clinical trials to include standardized administration and that it would be appropriate for the pharmaceutical industry to investigate this.



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