2001 future of drug labeling
DESCRIPTION
Onward to Electronic Drug Labeling Information repositoryTRANSCRIPT
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