1. Labeling Prescription Drugs for Physicians and Consumers 48 th Annual Conference Preparing for the Next Century of Food and Drug Regulation Food and Drug Law Institute April 8, 2005 Washington, DC

2. Labeling Prescription Drugs for Health Professionals and Consumers Susan C. Winckler, BS Pharm, JD Vice President, Policy and Communications Staff Counsel The American Pharmacists Association 202-429-7533SWinckler@APhAnet.org

3. Goal of Prescription Drug Labeling and Private Sector Initiatives? Improve medication use –Requires clear, consistent information for prescribers –Requires clear, consistent information for pharmacists –Requires clear, consistent information for consumers Meeting the needs of health care professionals and consumers requires different approaches

4. The Pharmacists Role Clinical consultation with prescribers –Monitor for drug interactions, allergies, concomitant conditions, etc. Working with consumers to make drugs work –The technology in the bottle doesnt help anyone if its not used well

5. Current Drug Labeling/Private Sector Information Helps… Drug label is good resource Patient information, FDA-approved or private-sector generated, is good resource –Paper alone doesnt solve the problem All resources require interpretation and application –When the metric is distribution and relative usefulness of just one component, do we actually help prescribers or consumers?

6. Recognize Limits of Drug Labeling in Practice Excludes off-label information –Gap for health care professionals Use other resources –Gap for patients Relevance of information decreases dramatically when medication used for off-label purpose Mandated information can miss the mark –Medication Guide for antidepressants re: pediatric suicidality Consumer Medicine Information can help –Still face limitations to personalization

7. Recognize Limits of Drug Labeling in Practice Language issues –English version may not be helpful to consumers –Font size may not be appropriate –Health literacy challenges –One size fits all Consumer Medicine Information can help, but faces challenges as well –Print in different languages –Limits of equipment…like printer toner/ribbons

8. Recognize Limits of Drug Labeling in Practice Delivery Methods –Paper and glue? Tear-off pads? Information outdated with one change –Celecoxib labeling immediately outdated once revisions are settled; arguably outdated today because we know changes are coming –Paperless labeling initiative will help with package inserts How many is enough? Consumer Medicine Information better because generated at the pharmacy –Still face limitations of equipment

9. One other limitation… Myriad formats require myriad approaches –Navigate which medications have PPIs or Medication Guides If you have a general Medication Guide, would patient benefit from specific CMI as well? –Unit-of-use packaging essential to efficient distribution of PPIs and Medication Guides –Explore incorporating mandated information into CMI systems

10. Information is helpful, strive for improvements Focus on end-user of information –Health care professional or consumer Focus on reality of that end-use –How is information used in the doctors office/pharmacy/consumers home? Focus on integration –Drug by drug approach perpetuates challenges

11. Remember the role of the paper… Its a resource, not the answer.