Transcript Structured Product Labeling

Structured Product Labeling
A View from the Working Group
June 4, 2004
“Change has a considerable psychological impact on the
human mind. To the fearful it is threatening because it
means that things may get worse. To the hopeful it is
encouraging because things may get better. To the
confident it is inspiring because the challenge exists
to make things better.”
– King Whitney Jr.
A Brief History of SPL
 Motivated by internal government recommendations, initiatives and
legal mandates, the FDA sought a more sophisticated means for
the exchange of the content of labeling
 SPL Standard initially developed by a small group within the HL7
Regulated Clinical Research Information Management Technical
Committee
 Although originally based upon the Clinical Document Architecture
standard, it has come to be known as more of a “sibling” than a
“child” of CDA
 PhRMA HL7 Task Group formed the SPL Working Group in
January to further the work of the initial development team
 In May 2004, SPL passed the HL7 Committee Ballot process and
is now eligible to be an ANSI standard
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The SPL Working Group
48 active members, including representatives from
HL7, Sponsors, FDA and Vendors
 Health Level 7:
 Sandy Boyer, Gunther Schadow
 FDA:
 Steve Gitterman, Lisa Stockbridge,
Donavan Duggan
 Vendors:
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Arbortext
Data Conversion Laboratory
I4i
Intrasphere
Liquent
Thomson
 Sponsors:
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Abbott
Astrazeneca
Aventis
Bayer
Boehringer-Ingelheim
Bristol-Myers Squibb
DEY
Ipsen
Johnson & Johnson
Lilly
Merck
Pfizer
Proctor & Gamble
Novartis
Roche
Wyeth
Team Objectives / Accomplishments
 Raise industry awareness concerning SPL
 Sponsor industry webcasts and meetings, as appropriate
 Detailed review of HL7 model (completed)
 Sandy Boyer has led the team through a detailed review of HL7 SPL
standard, and in discussions during team meetings
 Develop a generic XSL Style Sheet (completed)
 Robert Wallace led a team in the development of a common presentation
of SPL labeling content (IntraSphere hosting)
 Author an Implementation Guide (in-process)
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Chief Editor: Sandy Boyer (HL7)
Assistant Editor: Robert Wallace (Lilly)
Process Section Lead: Glenda Casper (Wyeth)
Technical Section Lead: Keith Thomas (i4i)
 Pilot test the SPL exchange with FDA (3Q)
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Goals of SPL
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Human-readable labeling content compatible across systems
Faster dissemination of labeling to improve risk management
More efficient evaluation of labeling changes
More coordinated data collection and storage
Better support for analysis of data
Improved interoperability with other systems
Improved integration of clinical data
Improved access by prescribers and consumers
Support for retention of legacy product labeling
The Best Things About SPL…
 SPL markup maintains human readability while providing
machine processability
 SPL allows scalable implementation of document markup
 SPL is flexible – e.g., doesn’t impose naming or nesting of
sections
 SPL markup facilitates exchange of product labeling
documents
 Local tag names can be mapped to SPL
 “One transformation away from exchange”
 SPL facilitates modular handling of document sections
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Benefits to Sponsors
 Efficiency of exchange – submit only those sections or data
elements that have changed
 Eliminate redundant data collection by use in other
submissions (such as drug listing)
 Increased efficiency in the internal label management process
 Catalyst towards the development of XML-based authoring
 Allows for the potential for more re-usable product content
across the enterprise
 Separates the format of a label from its content
 Defines a consistent, predictable means of exchanging
labeling content
 Utilizes a flexible, open standard
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Challenges to Sponsors
 Implementation period for conversion to SPL
 Pilot testing, validation effort, lack of facilitating software, ability to
budget for the implementation
 Transition to SPL raises questions
 Only labels after cut-over date, conversion of legacy labeling, use
during on-going label negotiations
 New standard and new technology
 Synchronization of data and narrative, learning curve with new
technology
 SPL and the eCTD
 Global Harmonization of Product Information / Labeling
standards
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Prescription for Success
 Project Manager / Coordinator
 Follow the Defined Process
 Schedule and Coordinate Conference Calls or Face-to-Face
Meetings
 Reports Back to RCRIM
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Industry Subject Matter Experts (Bus. and IT)
Vendor Representation (Assist with Tools)
FDA Representation
HL7 Developer with Subject Matter Knowledge
International Health Authority participation
HL7 RCRIM: Organizational Diagram
HL7 - RCRIM TC
Data Council
R. Levin (FDA)
B. Tardiff (Regeneron)
L. Quade (Lilly)
RCRIM Working Teams (Open Industry Participation)
ECG
Waveform
(Completed)
Animal Tox
(SEND Team
Working)
CDISC Members
Software
Protocol Rep.
(CDISC Team
Working)
Stability
(PhRMATeam
Working)
Product Label
(PhRMA Team
Working)
Additional
Teams (as
required)
HL7 Members
PhRMA HL7
Task Group
Healthcare
(Clinics, Hosp.)
CROs
Software
Consultants
Pharmaceutical
Companies
Consultants
HHS
A Model for the Future…
 Work together to ensure the development of standards that
will work for all sides within our industry
 Involvement from the beginning in standard development
 Collaborate on industry priorities with the FDA Data Council
 Promote open RFI / RFP process to involve appropriate
vendors
 Pilot new standards
 Leverage open SDO forums as a mechanism for global
harmonization
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“What we need to do is learn to work in the system, by
which I mean that everybody, every team, every
platform, every division, every component is there not
for individual competitive profit or recognition, but for
contribution to the system as a whole on a win-win
basis.”
W. Edwards Deming (1900 - 1993)
End of Presentation