Labeling Prescription Drugs for
Physicians and Consumers
48th Annual Conference
Preparing for the Next Century
of Food and Drug Regulation
Food and Drug Law Institute
April 8, 2005
Washington, DC
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
Goal of Prescription Drug Labeling and
Private Sector Initiatives?
 Improve medication use
– Requires clear, consistent information for
– Requires clear, consistent information for
– Requires clear, consistent information for
 Meeting the needs of health care
professionals and consumers requires
different approaches
The Pharmacist’s Role
 Clinical consultation with prescribers
– Monitor for drug interactions, allergies,
concomitant conditions, etc.
 Working with consumers to ‘make drugs
– The technology in the bottle doesn’t help
anyone if it’s not used well
Current Drug Labeling/Private Sector
Information Helps…
 Drug label is good resource
 Patient information, FDA-approved or
private-sector generated, is good
– Paper alone doesn’t solve the problem
 All resources require interpretation and
– When the ‘metric’ is distribution and relative
usefulness of just one component, do we
actually help prescribers or consumers?
Recognize Limits of Drug Labeling in
 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
 Consumer Medicine Information can help
– Still face limitations to ‘personalization’
Recognize Limits of Drug Labeling in
 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
Recognize Limits of Drug Labeling in
 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 Information outdated with one change
– Celecoxib labeling immediately outdated once
revisions are settled; arguably outdated today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
 How many is enough?
 Consumer Medicine Information better because
generated at the pharmacy
– Still face limitations of equipment
One other limitation…
 Myriad formats require myriad
– 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
Information is helpful, strive for
 Focus on end-user of information
– Health care professional or consumer
 Focus on reality of that ‘end-use’
– How is information used in the doctor’s
office/pharmacy/consumer’s home?
 Focus on integration
– Drug by drug approach perpetuates
Remember the role of the paper…
It’s a resource, not ‘the’ answer.

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