3rd Quarter 2007

Managing Risk and Patient Safety with FDA Medication Guides

By Edgar H. Adams

In the second quarter edition of Insights, we noted that Covance participated in the Food and Drug Administration's (FDA) Medication Guide Meeting, held on June 12-13, 2007 in Washington, DC. Active participation in these meetings is part of our commitment to contribute to the development of US and EU guidelines and the ongoing discussions and policy forums on risk management and patient safety.

The FDA was urged to make Medication Guides easier to read and understand and to consider combining the information included in the guides with other patient information. Currently patients may receive information from the consumer medical information (CMI), medication guide, patient product insert, and a patient information sheet.

The following is a summary of the recommendations made to the FDA:

1. Increase awareness of the Medication Guide program among consumers and health care professionals. For example, include a symbol on the prescription label indicating that a Medication Guide is available.
   
2. Provide both benefit and risk information on the guides.
   
3. Increase cooperation among all stakeholders, including the state and national boards of pharmacy and other professional associations that share responsibility for producing and distributing Medication Guides, to ensure that the obligations for proper patient education are met.
   
4. Start using Medication Guides, currently only distributed at the pharmacy, as the basis for a discussion between physician and patient regarding the medication. Improve distribution of the guides through Web sites and email.
5. Base FDA communication methods on scientific research of the utility, balance, and comprehension of the communication tools in order to reach the broadest audience.
   
6. Combine the Medication Guides with CMI, write the combined publication at the 6th to 8th grade level, and include both benefit and risk information. This is consistent with the Covance recommendation that a truly informed benefit risk decision can be made only if both benefit and risk are discussed in context.

A meeting summary and full transcripts are available here: www.fda.gov/cder/meeting/SummaryPublicHearingMedicationGuides.htm and http://www.fda.gov/cder/meeting/medication_guides/0612FDA.pdf and http://www.fda.gov/cder/meeting/medication_guides/0613FDA.pdf

For further information on Medication Guides and risk management tools, please contact Covance.