Transcript recommendations - National Council on Patient Information and

Drug Information for Consumers
and Healthcare Professionals
Food and Drug Law Institute Annual Meeting
Alan Goldhammer, PhD
Associate VP Regulatory Affairs
Pharmaceutical Research and Manufacturers
of America
Importance of Communication
• An Educated Patient must be Goal #1
• Improved Health Outcomes from
Maximizing the Benefit and Minimizing
the Risk is the Desired Result
Basis of all Communication
FDA-Approved Drug Label is the
synthesis of all the information
acquired from the drug development
program. It provides the important
information that physicians need to
treat their patients.
Useful Consumer Information
• Comes in Many Forms
• Increases Patient Knowledge and
Awareness about Disease States and
Treatment Options
• Leads to Improved Health Outcomes
Role of Integrated Consumer Education
Campaigns
Awareness
Depth of Education
Physician / Patient
discussions
Compliance
Mass-reach advertising
(TV/Print/PR)
Websites, toll-free numbers,
patient education
Physician visit / Write Rx
Patient education on
use of product
Each media has different strengths and purpose
in comprehensive communication campaign
Information Available at
Dispensing
• Medication Guides
• Patient Package Inserts
• Consumer Medication Information
Paperless Labeling
Industry Initiative to Move Beyond Paper
Prescribing Information to Deliver a
Fully Implemented Electronic System
at Every US Dispensing Site
The Current Regulation
• 21 CFR § 201.100 Prescription drugs
for human use
– A drug subject to the requirements of
section 503(b)(1) of the act shall be
exempt from section 502(f)(1) if all the
following conditions are met:
– (c)(1) Labeling on or within the package
from which the drug is to be dispensed
bears adequate information for its use,
including . . .
The Current Product
• “Less than User-Friendly”
• Current???
• Bizarre sizes
– the scroll
– the newspaper
– the wallpaper
• Mouse-size print
• Not always retained in pharmacies
• New FDA Rule to Require Longer Labels is
Pending
The Paperless Labeling
Task Force Proposal
• The current labeling for all marketed
prescription products to be available
electronically at no cost to all
dispensing locations.
• “PDF” versions, using free software,
available for viewing or printing.
• “Bar-coded” labels would allow direct
access to product-specific labeling
Advantages to Proposal
• Pharmacists will have access to the
most recent labeling
– Public Health Benefit
• Labeling would be readable on screen
• Pharmacist can quickly scan to section
of interest
• No possible product misbranding due
to package insert mix ups
User Requirements
• Readily Accessible
• Timely – label updates will be provided daily
• Comprehensive
• User Friendly
• Standardized
• Printable
• Rapid access codes (“bar-coded”)
User Requirements (cont’d.)
• Text cannot be changed
• Virus protected
• Cost-neutral to dispensing site
• Available at all dispensing sites
Status and Next Steps
• Proof of Concept Test (summer ’03)
• Large Scale Field Test ( Nov ’04-Feb
’05)
• Work with FDA and other stakeholders
on full scale implementation
• Commercial Rollout in 2006????
Priority Goals
• Talk to your doctor, pharmacist, or
other health care professionals.
• Know your medicines.
• Read the label and follow
directions.
• Avoid interactions.
• Monitor the medicine’s effects.