pillbox - restructuring structured product data
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executive overview of NLM Pillbox for U.S. Pharmacopoeia's Nomenclature Expert CommitteeTRANSCRIPT
Pillbox
RestructuringStructured Product Data
David Hale, Project ManagerNational Library of MedicineNational Institutes of Health
U.S. Pharmacopoeia Nomenclature Expert CommitteeJanuary 12, 2010
ObjectivesEnhance compliance
System for comparative reviewTechnology for validation of physical
characteristics data
Reduce Adverse Drug Events (ADEs)Solid dose form (SDF) identification system
Support Open Government Directive/US CIOPlace all data in public domainProvide direct access for Health IT developers Promote innovation
Partners in Development VA
HHS/ASPR
FDA/Forensic Chemistry Center
USP
Manufacturers
Poison Control Centers
Emergency Medical Services
Emergency Doctors
Primary Care Providers
Smithsonian photographers
Industry/trade orgs
Standards orgs
Health insurers
Computer scientists
Research scientists
Informatics specialists
Medical librarians
Information architects
Graphic designers
Patient advocates
Medical consultants
Non-profits orgs
Health community managers
Startups
Bloggers
Physical characteristics data of solid dose forms in the SPL
Difficult to validateFrequently incorrect
Unusable by those who need it most“Trapped” inside the SPL
Missing images Image libraries currently available are of poor
quality or proprietary
Solution – PillboxStructured Product Label (SPL)
1:manyone label, many dosage forms
Pillbox lookup table1:1
each dosage form has single recordDerived from SPL + RxNormRxNorm
standardized nomenclature, innovator/genericEventually SPL-only
MetadataBased on SPL
Benefit – standardized
Liability – limited OTCs, supplements
Fields imprint, shape, color, size, score ingredients, excipients innovator/generic, author, DEA scheduleNDC product code, SETID
ImagingNLM/FDA cooperative project
Developing standards, methodology for high-res imaging of SDFs Will become SPLIMAGE guidance
FDA providing Funding Strategy/operations Physical space Pharmacists
Pillbox photography lab (Rockville, MD) NLM contractors FDA pharmacists
Imaging WorkflowSponsors provide samples
NLM has purchased certain generic samples (~1,000)
Perform imaging
Creation of SPL-ready image
Images provided to sponsors
Sponsors submit images to FDA for inclusion in label
Images become part of the Structured Product Label
Medicos ConsultantsPharmaceutical informatics based on SPL
CEOSurgeon
CTOVideo game designer
PhotographerRecently in the Amazon, shooting close-up images
of reptiles and insects
Access – PillboxResearch and development
Biomedical informaticsEthnographic persona development Information architectureUser experience
FunctionsRapid identificationComparative reviewPromotion/awarenessHealth literacy
Visualization of data highlights errorsSearches for rectangle, oval, 1mm, purple
Access – Pillbox betaWhy beta?
Images have not been asserted by sponsorsImages are added to Pillbox beta once validated by
NLMSome data is from NLM2,000 grandfathered meds, OTCs missing from SPL
NLM must generate data for missing records
Pillbox (non-beta)All data and images derived from SPL
Access – APIAPI = Application Programming Interface
API allows software developers to create applications which query Pillbox
Drive traffic to data Driving traffic to NLM website will not save lives
Functions Pill identification, medication information, public
safety, increase health literacySolitaire for Windows designed to teach use of mouse
Websites, mobile devices (iPhone, Andriod, BlackBerry), Facebook, other (NDA)
Promote innovation
Next Steps Call to sponsors for samples
Imaging Sponsor submission of images to FDA for inclusion in SPL
OTCs
EMEA
Promotion of API
Automated validation of images
Automated validation of physical characteristics data based on images
Enhancement of search experience through image processing
Automated identification of unknowns
NLM & USP as partnersExpertise
Support
Promotion
Partnership in creating a community of innovation
Pillbox
RestructuringStructured Product Data
David Hale, Project ManagerNational Library of MedicineNational Institutes of Health
U.S. Pharmacopoeia Nomenclature Expert CommitteeJanuary 12, 2010