Pharmaceutical Labeling 2001 1

Exploring Electronic Medication Exploring Electronic Medication InformationInformation

A Plan for the Future A Plan for the Future Making It Happen for Making It Happen for

Everyone’s BenefitEveryone’s Benefit

Stephen A. WeitzmanStephen A. WeitzmanDataPharm FoundationDataPharm Foundation

EMIS PLAN2

OverviewOverview

• BackgroundBackground• Benefits Benefits • The Approaches to ProblemsThe Approaches to Problems• Technical Issues & ImpedimentsTechnical Issues & Impediments• Resolution – Universal Collaboration Resolution – Universal Collaboration

Thru DataPharmThru DataPharm

EMIS PLAN3

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 Approval On going development as part of Medicines Approval

Process across EuropeProcess across Europe

FDA - Steps for Preparation of FDA - Steps for Preparation of Labeling for Review and Labeling 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 single Tape 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 the Repeat for each example used in the

comparison and reviewcomparison and review

FDA - Processing and Review of FDA - Processing and Review of Labeling ChangesLabeling Changes

• Word for word comparison with previous Word 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

EMIS PLAN6

FDA-Processing Labeling ChangesFDA-Processing Labeling ChangesAn Efficient Label Management Iteration ProcessAn Efficient Label Management Iteration Process

FormatValid?

MedID

PriorApproval?

SignOff?

Accept?Company

Public

NoNo

No

Update

Yes

No

Edit

Yes Update

Export

FDA

New or Change Yes

CBE’s

EMIS PLAN7

EMIS=Making Current Information Available EMIS=Making Current Information Available – Through an Efficient Electronic Process– Through an Efficient Electronic Process

A Central

Clearing-house and

Repository

Paper Publishing

CompaniesPharmacies& Other Dispensers

Website

Free PublicWebsite

Labeling& Listing

FinalApprovedLabeling

FDALabelingReviewPI, PPI& Listing

Professional Systems

To Public

E-Health

Public

Medication InformationCoding

Minor changes

Healthcare

EMIS PLAN8

Gathering, Processing and DistributingGathering, Processing and DistributingElectronic Medications InformationElectronic Medications Information

FormatValid?

Repository &Archive

PriorApproval?

SignOff?

Accept-FDA?Company

NoNoNotNeeded

Yes

NoEdit

Change Yes

Any Company

1) Format –DTD - Tools2) Secure Interchange3) 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

EMIS PLAN9

PharmaceuticalCompanies

©PIs

©PPIsFDA/

FDA INTRANET

Other

Regulatory

FDA WORKFLOW PROCESSING SYSTEM

First DataBank etc.

Professional Systems Electronic PublishingeMC Website

Virtual Health Network PDR etc.

System Vendors ToGP, Hospital ,Pharmacy

Electronic PublishersCD Pubs, Internet Sites,Intranet

Digital Service Providers

Printed ProductsPrinting 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

DataPharmPartnerFDA-CDERFDA-CDER

MID-RepositoryMID-Repository

EMIS PLAN10

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

HDMAHEALTHCOM&

Others

PharmaciesDispensers

Managed Care

Other health related

organizations and experts

EMIS PLAN11

XML

Associated Files

SourceFile

�

Applicant EMEA

Human readable format

PIM - Current approach PIM - Current approach - the Phase 1 Model- the Phase 1 Model

XML

Associated Files

X Dossier X Dossier

Product Approval Process

EMIS PLAN12

Benefits from PIM Benefits 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 agencies Faster notification of changes proposed by agencies

or industryor industry• Capability to support administrative aspects of Capability to support administrative aspects of

Decision Making Process and reduce timeDecision Making Process and reduce time

EMIS PLAN13

Common ObjectivesCommon Objectives

• Improve Efficiency – Reduce Personnel Costs Improve Efficiency – Reduce Personnel Costs For Industry & GovernmentFor Industry & Government– Efficient Submission Process Efficient Submission Process

• FDA, PIMFDA, PIM

– Efficient Distribution Process Efficient Distribution Process • FDA, eMCFDA, eMC

– Improving Accessibility Improving Accessibility • FDA, PhRMA, eMC, PIMFDA, PhRMA, eMC, PIM

EMIS PLAN14

Electronic Labeling has been here Electronic 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 used We are really addressing is how Electronic Labeling will be used and whether paper will be displaced.and whether paper will be displaced.

EMIS PLAN15

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 all Because it has Substantial Benefits to all Stakeholders which can be achieved in the short Stakeholders which can be achieved in the short term and long term. term and long term.

EMIS PLAN16

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 Professionals Healthcare, Healthcare Professionals – Prescribers, Dispensers – incl. HMO’s & Ins.Prescribers, Dispensers – incl. HMO’s & Ins.

• Information ProvidersInformation Providers– Publishers and e-HealthPublishers and e-Health

EMIS PLAN17

Common Benefits to the Public Common 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 of authoritative and comprehensive database of information.information.

Current systems for drug labeling collection and dissemination to Current systems for drug labeling collection and dissemination to professionals and patients is flawed: information disseminated may be professionals and patients is flawed: information disseminated may be out-of-date, sources are questionable, and therefore we have a out-of-date, sources are questionable, and therefore we have a potentially dangerous situation resulting in medical errors and injury potentially dangerous situation resulting in medical errors and injury due to:due to:

providers = incorrect prescriptionsproviders = incorrect prescriptionsdispensers = incorrect prescriptionsdispensers = incorrect prescriptions

consumers = non-compliance and insufficient vigilanceconsumers = non-compliance and insufficient vigilance

EMIS PLAN18

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 are websites 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 2001 Susan 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 common list of common

medication errors: unavailable drug information (such as lack of up-to-date medication errors: unavailable drug information (such as lack of up-to-date warnings). FDA Consumer, August 2000.warnings). FDA Consumer, August 2000.

EMIS PLAN19

The Current SituationThe Current Situation• There is no up-to-date, comprehensive, and accurate There 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 same FDA 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 drug U.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

EMIS PLAN20

The SolutionThe Solution

Establish a continuously-updated resource of labeling that Establish 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 healthcare and distributes that information further throughout healthcare

through publishers, health, and healthcare systems for through publishers, health, and healthcare systems for

prescribers and dispensers.prescribers and dispensers. A Principal Purpose of DataPharmA Principal Purpose of DataPharm

EMIS PLAN21

Benefits for GovernmentBenefits for Government

• Improve the efficiency of the label preparation and Improve 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 Changes Speeding 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

EMIS PLAN22

Benefits to Industry Benefits to Industry • Public is better served – [Short Term]Public is better served – [Short Term]• An automated system may make the FDA review process more An 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 through Consolidated distribution of label data by manufacturers through a single outlet to all publishers and e-health sites a single outlet to all publishers and e-health sites

• Stimulate better value added products from multiple information Stimulate better value added products from multiple information vendorsvendors

• Products liability argumentProducts liability argument• Eventual discontinuation of paper labelingEventual discontinuation of paper labeling

EMIS PLAN23

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

EMIS PLAN24

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

EMIS PLAN25

ObstaclesObstacles• Industry – Short term restructuring processIndustry – Short term restructuring process• Medical Professionals Medical Professionals

– Not integrated in their workflow process at decision making Not integrated in their workflow process at decision making points points

• Pharmacy Pharmacy – Absence of universal access Absence of universal access – Not integrated in their systems so that it is a distraction to Not 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

EMIS PLAN26

The Approaches In DetailThe Approaches In DetailTo 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 2000See EMEA WebsiteSee EMEA Website

– DataPharm FoundationDataPharm Foundation

EMIS PLAN27

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 Format New FDA Professional Information Format http://www.fda.gov/oc/health/physlabel.htmlhttp://www.fda.gov/oc/health/physlabel.html

– Amending Regulatory Requirements For Data Amending Regulatory Requirements For Data Submission Submission

EMIS PLAN28

Resolution:Resolution:Universal CollaborationUniversal Collaboration

• Reduce funding requirements by adoption of Reduce funding requirements by adoption of existing workable systemsexisting workable systems

• Close collaboration of Stakeholders in Close collaboration of Stakeholders in technical development of systemstechnical development of systems