VT PowerPoint Template...Title VT PowerPoint Template Author David Stanley Created Date 9/8/2010...
Transcript of VT PowerPoint Template...Title VT PowerPoint Template Author David Stanley Created Date 9/8/2010...
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September 8, 2010
The Electronic Drug Label –Coming to an Information System Near You
Suzanne L. Santamaria, DVM
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“Information is care”
Dr. Donald Berwick,
President of the
Institute for
Healthcare
Improvement
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SPL – Structured Product Label
• An electronic document to relate product
regulatory information in a standardized,
structured way
• Accurate, timely, and enhanced
• FDA
• Caregivers
• Researchers, drug companies, etc.
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SPL: Standards within standards within
standards within…
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Standards enhance communication
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GUID
Local:
model, lot,
serial
OID
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XML facilitates information
transformation
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XML
Web
Spreadsheet
Database
PrintAny or all information in
the XML document can
be transformed (as
needed)
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Sty
lesheets
+ b
usin
ess ru
les
Drug listingDaily Med Web Display
Data transformation(stylesheet)
Web display transformation(stylesheet)
Veterinary Labels(XML Documents)
SPLSchema
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SPL transforms provide rules for
transforming software• Appropriate stylesheets for viewing can be
prepared for intended users
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Document meta-data enables
identification
Identifier
Effective time
Title
Version
Label
type code
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SPL divided into label sections
Identifiers
Effective
time
Title
Text
Subsections
Highlights
Video
Image
Section
type code
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WARNING: XML CODE!
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SPL label section computer-
readable info
human-
readable info
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Label sections rendered with
FDA stylesheet
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SPL increases utility of
traditional content of labeling• Links
• Color images
• Videos
• Reader assistance
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SPL improves
results/outcomes when used
for primary purpose of
prescribing a drug
http://www.technooutlet.com/cafi176.html?source=GGAN
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SPL improves information flow
Printed labels
Approved SPL FDA data
systems
Patient info.
systems
Drug Info
systems
Drug listing
Drug
“indexing”
Est.
registration
Out of business
notification
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SPL contains detailed drug info
Product namePackaging
Dosage form
Strength
Inactive
ingredients
Active
ingredients
Quantity
DEA
Schedule
Route of
administration
Solid oral: color, shape,
size, scoring, imprint
Image
Marketing
status
Approval
www.ricespharmacy.com/1648644.html
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Indexing increases label utility
Pharmacologic
class
Indication
Maximum dose
Condition of use
Limitation of use
Adverse reaction
Interactions
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Are we all going to fit?
May work well….
Content of labeling
Terminologies
Schema?
May need help…
Stylesheet
Terminology subsets
Animals
Indexing by animal
Indications
Adverse
reactions
Interactions
Withdrawal times
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Indexing section rendered with
FDA’s current stylesheet
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Benefits of SPL will grow over
time
www.thechefalliance.com/cms/33
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Rome wasn’t built in a day
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SPL implementation in phases
Summer2009
Drug Listing & Establishment Registration mandatory
Content of labeling mandatory
Indexing mandatory
?? ??
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SPL involves many parties
FDA
Software
vendors
Drug
companies
HL7 Working
Group
Veterinarians
Animal
caregivers
SPL
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25http://www.fda.gov/ForIndustry/DataStandards/StructuredProdu
ctLabeling/default.htm
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http://spl-work-
group.wikispaces.com/
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The more vets ask for SPLs
the more likely the FDA, drug
companies and vendors will
provide them
http://go635254.s3.amazonaws.com/cleantechnica/fi
les/2010/06/Demand.jpg
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Questions?
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http://imgs.sfgate.com/c/pictures/2010/07/29/ba-
Germany_Zoo_A_0502023731.jpg
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Acknowledgements
• Appreciation for funding support:
• FDA Center for Veterinary Medicine
• Appreciation for assistance:
• Dr. Jeff Wilcke
• Dr. Julie Green
• Maureen Fallon
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