This document discusses plans for an electronic medication information system (EMIS) to improve the process of creating, reviewing, and distributing drug labeling information. It outlines current inefficient paper-based systems used by the FDA and drug companies, and proposes a collaborative electronic approach through DataPharm that would standardize formats, securely share information, and make approved labeling instantly available to healthcare providers and the public through various electronic channels. This system aims to increase efficiency, accessibility of up-to-date information, and benefit all stakeholders including patients.

1. Pharmaceutical Labeling 2001 1
Exploring Electronic MedicationExploring Electronic Medication
InformationInformation
A Plan for the FutureA Plan for the Future
Making It Happen forMaking It Happen for
Everyone’s BenefitEveryone’s Benefit
Stephen A. WeitzmanStephen A. Weitzman
DataPharm FoundationDataPharm Foundation

2. EMIS PLAN
2
OverviewOverview
• BackgroundBackground
• BenefitsBenefits
• The Approaches to ProblemsThe Approaches to Problems
• Technical Issues & ImpedimentsTechnical Issues & Impediments
• Resolution – Universal CollaborationResolution – Universal Collaboration
Thru DataPharmThru DataPharm

3. EMIS PLAN
3
BackgroundBackground
• Four Overlapping ProjectsFour Overlapping Projects
– FDA Electronic Submissions – 1999FDA Electronic Submissions – 1999
• On going developmentOn going development
– PhRMA Paperless Labeling (10/1998)PhRMA Paperless Labeling (10/1998)
• On going developmentOn going development
– Electronic Medicines Compendium U.K. -1997Electronic Medicines Compendium U.K. -1997
• Launched in 1999 and in second (XML) versionLaunched in 1999 and in second (XML) version
• U.S. Version in progressU.S. Version in progress
– Product Information Management (EMEA) 1998Product Information Management (EMEA) 1998
• On going development as part of Medicines ApprovalOn going development as part of Medicines Approval
Process across EuropeProcess across Europe

4. FDA - Steps for Preparation ofFDA - Steps for Preparation of
Labeling for Review andLabeling for Review and
ComparisonComparison
• Photocopy parts of package insertPhotocopy parts of package insert
• Cut copy of package insert into partsCut copy of package insert into parts
• Photocopy again to enlarge each partPhotocopy again to enlarge each part
• Tape each part together so it will fit on a singleTape each part together so it will fit on a single
sheet of papersheet of paper
• Photocopy taped paperPhotocopy taped paper
• Repeat for each example used in theRepeat for each example used in the
comparison and reviewcomparison and review

5. FDA - Processing and Review ofFDA - Processing and Review of
Labeling ChangesLabeling Changes
• Word for word comparison with previousWord for word comparison with previous
examples of labelingexamples of labeling
• Identify all changesIdentify all changes
• Review changesReview changes
• Negotiate changes with applicantNegotiate changes with applicant
• Distribute new labeling internallyDistribute new labeling internally

6. EMIS PLAN
6
FDA-Processing Labeling ChangesFDA-Processing Labeling Changes
An Efficient Label Management Iteration ProcessAn Efficient Label Management Iteration Process
Format
Valid?
MedID
Prior
Approval?
Sign
Off?
Accept?Company
Public
NoNo
No
Update
Yes
No
Edit
Yes Update
Export
FDA
New or
Change Yes
CBE’s

7. EMIS PLAN
7
EMIS=Making Current Information AvailableEMIS=Making Current Information Available
– Through an Efficient Electronic Process– Through an Efficient Electronic Process
A
Central
Clearing-
house
and
Repository
Paper Publishing
Companies
Pharmacies
& Other Dispensers
Website
Free Public
Website
Labeling
& Listing
Final
Approved
Labeling
FDA
Labeling
Review
PI, PPI
& Listing
Professional Systems
To Public
E-Health
Public
Medication Information
Coding
Minor changes
Healthcare

8. EMIS PLAN
8
Gathering, Processing and DistributingGathering, Processing and Distributing
Electronic Medications InformationElectronic Medications Information
Format
Valid?
Repository &
Archive
Prior
Approval?
Sign
Off?
Accept
-FDA?Company
NoNo
Not
Needed
Yes
No
Edit
Change Yes
Any
Company
1) Format –DTD - Tools
2) Secure Interchange
3) Multiple Formats:
Word, PDF, Paper ..
P1 SubmissionsP1 Submissions P2 FDA WorkflowP2 FDA Workflow
Coding
Paper Publishing
Pharmacies
& Other Dispensers
Professional
Systems
E-Health
Public
Healthcare
P3 CodingP3 Coding
Yes
P4P4
P5P5

9. EMIS PLAN
9
Pharmaceutical
Companies
©PIs
©PPIs
FDA/
FDA
INTRANET
Other
Regulatory
FDA WORKFLOW PROCESSING SYSTEM
First DataBank etc.
Professional Systems Electronic Publishing
eMC Website
Virtual Health Network PDR etc.
System Vendors To
GP, Hospital ,Pharmacy
Electronic Publishers
CD Pubs, Internet Sites,Intranet
Digital Service Providers
Printed Products
Printing on demand,Compendia
End Users
GP’s Hospitals Pharmacists
PIs & PPIs Origination,
Approval & Repository
End Users
Healthcare professionals & Public
End Users
Healthcare professionals & Public
Paper Publishing
Electronic Medication Information
Systems
Information Collection, Review, Distribution
Access to Medicines Information
DataPharm
Partner
FDA-CDERFDA-CDER
MID-RepositoryMID-Repository

10. EMIS PLAN
10
Structure
DataPharm U.S.
Executive
Board
Steering C.
Members
FDA
Datapharm U.K.
Advisory
Groups
MID
Input
Public
WebsiteStakeholders
FDA –Info.
Output
Development & Maintenance
DataPharm Others
NLM
ALL
3rd
Party Sites
HDMA
HEALTHCOM&
Others
Pharmacies
Dispensers
Managed Care
Other
health
related
organizations
and experts

11. EMIS PLAN
11
XML
Associated
Files
Source
File
Applicant EMEA
Human readable
format
PIM - Current approachPIM - Current approach
- the Phase 1 Model- the Phase 1 Model
XML
Associated
Files
X Dossier X Dossier
Product Approval Process

12. EMIS PLAN
12
Benefits from PIMBenefits from PIM
• Removes duplication of work across a productRemoves duplication of work across a product
– Creation of documents by applicantCreation of documents by applicant
– Review of documents by agencyReview of documents by agency
• Brings resource efficienciesBrings resource efficiencies
• Faster notification of changes proposed by agenciesFaster notification of changes proposed by agencies
or industryor industry
• Capability to support administrative aspects ofCapability to support administrative aspects of
Decision Making Process and reduce timeDecision Making Process and reduce time

13. EMIS PLAN
13
Common ObjectivesCommon Objectives
• Improve Efficiency – Reduce Personnel CostsImprove Efficiency – Reduce Personnel Costs
For Industry & GovernmentFor Industry & Government
– Efficient Submission ProcessEfficient Submission Process
• FDA, PIMFDA, PIM
– Efficient Distribution ProcessEfficient Distribution Process
• FDA, eMCFDA, eMC
– Improving AccessibilityImproving Accessibility
• FDA, PhRMA, eMC, PIMFDA, PhRMA, eMC, PIM

14. EMIS PLAN
14
Electronic Labeling has been hereElectronic Labeling has been here
for 25 years or more..for 25 years or more..
• History of Electronic Labeling:History of Electronic Labeling:
– 197? – A text file in an Online System197? – A text file in an Online System
– 198? - A text file for use in a publishing system for printing–198? - A text file for use in a publishing system for printing–
– 199? - A PageMaker or PDF file – Formatted for Paper Publishing199? - A PageMaker or PDF file – Formatted for Paper Publishing
– 199? - An HTML/and or PDF file presented on the W.W.W.199? - An HTML/and or PDF file presented on the W.W.W.
– 1999 - Accepted by FDA for NDA submissions - 21 CFR Part 11.1999 - Accepted by FDA for NDA submissions - 21 CFR Part 11.
– 1999 eMC launched in U.K.1999 eMC launched in U.K.
• We are really addressing is how Electronic Labeling will be usedWe are really addressing is how Electronic Labeling will be used
and whether paper will be displaced.and whether paper will be displaced.

15. EMIS PLAN
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And The Answer Please -And The Answer Please -
Q.Q. Is it the Future of Labeling?Is it the Future of Labeling?
A.A. ABSOLUTELY - YES.ABSOLUTELY - YES.
Q.Q. Will it Replace Paper Labeling?Will it Replace Paper Labeling?
A.A. There is a Long Row To Hoe.There is a Long Row To Hoe.
Q.Q. Why is it the Future of Labeling?Why is it the Future of Labeling?
A.A. Because it has Substantial Benefits to allBecause it has Substantial Benefits to all
Stakeholders which can be achieved in the shortStakeholders which can be achieved in the short
term and long term.term and long term.

16. EMIS PLAN
16
The Stakeholders in the EvolutionThe Stakeholders in the Evolution
• The PublicThe Public
• GovernmentGovernment
• The Product Supply ChainThe Product Supply Chain
– Manufacturers, Distributors, RetailersManufacturers, Distributors, Retailers
• Healthcare, Healthcare ProfessionalsHealthcare, Healthcare Professionals
– Prescribers, Dispensers – incl. HMO’s & Ins.Prescribers, Dispensers – incl. HMO’s & Ins.
• Information ProvidersInformation Providers
– Publishers and e-HealthPublishers and e-Health

17. EMIS PLAN
17
Common Benefits to the PublicCommon Benefits to the Public
& All Stakeholders& All Stakeholders
• Facilitates the creation of a real-time up-to-date,Facilitates the creation of a real-time up-to-date,
authoritative and comprehensive database ofauthoritative and comprehensive database of
information.information.
Current systems for drug labeling collection and dissemination toCurrent systems for drug labeling collection and dissemination to
professionals and patients is flawed: information disseminated may beprofessionals and patients is flawed: information disseminated may be
out-of-date, sources are questionable, and therefore we have aout-of-date, sources are questionable, and therefore we have a
potentially dangerous situation resulting in medical errors and injurypotentially dangerous situation resulting in medical errors and injury
due to:due to:
providers = incorrect prescriptionsproviders = incorrect prescriptions
dispensers = incorrect prescriptionsdispensers = incorrect prescriptions
consumers = non-compliance and insufficient vigilanceconsumers = non-compliance and insufficient vigilance

18. EMIS PLAN
18
Who Says There Are Problems?Who Says There Are Problems?
• IOM Medical Errors –IOM Medical Errors – “More commonly, errors are caused by“More commonly, errors are caused by
faulty systems … that lead people to make mistakes.”faulty systems … that lead people to make mistakes.”
• Detwiler -Detwiler - “ Health information consumers rely on prominent health“ Health information consumers rely on prominent health
websites for up-to-date information on diseases and drugs, but the sites arewebsites for up-to-date information on diseases and drugs, but the sites are
not upholding their side of the bargain.”not upholding their side of the bargain.”
““The Medium Doesn’t Get the Message:The Medium Doesn’t Get the Message:
When does breaking health news become permanent information?”When does breaking health news become permanent information?”
A report on the currency of drug databases associated with health and medical websitesA report on the currency of drug databases associated with health and medical websites ––
Susan Detwiler January 2001Susan Detwiler January 2001 www.detwiler.comwww.detwiler.com
• Rand Study–Rand Study– California HealthCare FoundationCalifornia HealthCare Foundation
• American Hospital Association –American Hospital Association – list of commonlist of common
medication errors: unavailable drug information (such as lack of up-to-datemedication errors: unavailable drug information (such as lack of up-to-date
warnings). FDA Consumer, August 2000.warnings). FDA Consumer, August 2000.

19. EMIS PLAN
19
The Current SituationThe Current Situation
• There is no up-to-date, comprehensive, and accurateThere is no up-to-date, comprehensive, and accurate
drug database of labeling:drug database of labeling:
– FDA posts about 250 “professional” drug labels in the sameFDA posts about 250 “professional” drug labels in the same
version as at the time approved out of 10,000 drugsversion as at the time approved out of 10,000 drugs
– FDA also has about 60 “consumer” labels of its own creationFDA also has about 60 “consumer” labels of its own creation
– There are thousands of label changes each yearThere are thousands of label changes each year
– U.S. health sites have been found dependent on drugU.S. health sites have been found dependent on drug
databases that are not up-to-datedatabases that are not up-to-date
– Traditional search engines are deficientTraditional search engines are deficient

20. EMIS PLAN
20
The SolutionThe Solution
Establish a continuously-updated resource of labeling thatEstablish a continuously-updated resource of labeling that
provides a mechanism in “real time” for submission of accurate,provides a mechanism in “real time” for submission of accurate,
comprehensive and usable drug information for all audiences.comprehensive and usable drug information for all audiences.
Provide free of charge access to that information on the Web,Provide free of charge access to that information on the Web,
and distributes that information further throughout healthcareand distributes that information further throughout healthcare
through publishers, health, and healthcare systems forthrough publishers, health, and healthcare systems for
prescribers and dispensers.prescribers and dispensers.
A Principal Purpose of DataPharmA Principal Purpose of DataPharm

21. EMIS PLAN
21
Benefits for GovernmentBenefits for Government
• Improve the efficiency of the label preparation andImprove the efficiency of the label preparation and
review processreview process
• Enhancing public health by:Enhancing public health by:
Speeding Information about New Products and Label ChangesSpeeding Information about New Products and Label Changes
& Alerts to the public& Alerts to the public
– Assurance that changes in product data are complete,Assurance that changes in product data are complete,
accurate, and promptly disseminatedaccurate, and promptly disseminated
– Posted as health related label changes are made or requiredPosted as health related label changes are made or required
• Harmonization in a global environmentHarmonization in a global environment

22. EMIS PLAN
22
Benefits to IndustryBenefits to Industry
• Public is better served – [Short Term]Public is better served – [Short Term]
• An automated system may make the FDA review process moreAn automated system may make the FDA review process more
efficientefficient
– Reduce proofreading [Short Term]Reduce proofreading [Short Term]
– Shorten review times [Short Term]Shorten review times [Short Term]
• Consolidated distribution of label data by manufacturers throughConsolidated distribution of label data by manufacturers through
a single outlet to all publishers and e-health sitesa single outlet to all publishers and e-health sites
• Stimulate better value added products from multiple informationStimulate better value added products from multiple information
vendorsvendors
• Products liability argumentProducts liability argument
• Eventual discontinuation of paper labelingEventual discontinuation of paper labeling

23. EMIS PLAN
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Benefits for Prescribers &Benefits for Prescribers &
Healthcare GiversHealthcare Givers
• Access to the most current informationAccess to the most current information
– For prescribingFor prescribing
– For administeringFor administering
– In training at medical and nursing institutionsIn training at medical and nursing institutions
• Evolving ImprovementsEvolving Improvements

24. EMIS PLAN
24
Benefits to PharmacyBenefits to Pharmacy
• Access to the most current informationAccess to the most current information
– For drug utilization reviewFor drug utilization review
– For Training in Pharmacy SchoolsFor Training in Pharmacy Schools
• Further Standardization of Information CodesFurther Standardization of Information Codes

25. EMIS PLAN
25
ObstaclesObstacles
• Industry – Short term restructuring processIndustry – Short term restructuring process
• Medical ProfessionalsMedical Professionals
– Not integrated in their workflow process at decision makingNot integrated in their workflow process at decision making
pointspoints
• PharmacyPharmacy
– Absence of universal accessAbsence of universal access
– Not integrated in their systems so that it is a distraction toNot integrated in their systems so that it is a distraction to
workflow and therefore potentially costlyworkflow and therefore potentially costly
– There is a shortage of PharmacistsThere is a shortage of Pharmacists

26. EMIS PLAN
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The Approaches In DetailThe Approaches In Detail
To be presented at the sessionTo be presented at the session
• Comparisons, Overlap, AdvantagesComparisons, Overlap, Advantages
– eMC – Up and RunningeMC – Up and Running
• eMC.vhn.neteMC.vhn.net
– FDA – Presentation of July 2001FDA – Presentation of July 2001
http://www.fda.gov/cder/regulatory/ersr/labeling2/IM4167/tsld001.htmhttp://www.fda.gov/cder/regulatory/ersr/labeling2/IM4167/tsld001.htm
– PIM – Presentation of October 2000PIM – Presentation of October 2000
See EMEA WebsiteSee EMEA Website
– DataPharm FoundationDataPharm Foundation

27. EMIS PLAN
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Technical Issues & ImpedimentsTechnical Issues & Impediments
• FundingFunding
• Acceptance by Users (Critical to PhRMA)Acceptance by Users (Critical to PhRMA)
• Regulatory Changes In ProcessRegulatory Changes In Process
– New FDA Professional Information FormatNew FDA Professional Information Format
http://www.fda.gov/oc/health/physlabel.htmlhttp://www.fda.gov/oc/health/physlabel.html
– Amending Regulatory Requirements For DataAmending Regulatory Requirements For Data
SubmissionSubmission

28. EMIS PLAN
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Resolution:Resolution:
Universal CollaborationUniversal Collaboration
• Reduce funding requirements by adoption ofReduce funding requirements by adoption of
existing workable systemsexisting workable systems
• Close collaboration of Stakeholders inClose collaboration of Stakeholders in
technical development of systemstechnical development of systems