Pillbox - Restructuring Structured Product Data

PillboxRestructuringStructured Product Data
David Hale, Project Manager
National Library of Medicine
National Institutes of Health
david.hale@nih.gov
301.496.3042
U.S. Pharmacopoeia Nomenclature Expert Committee
January 12, 2010

Objectives
Enhance compliance
System for comparative review
Technology for validation of physical characteristics data
Reduce Adverse Drug Events (ADEs)
Solid dose form (SDF) identification system
Support Open Government Directive/US CIO
Place all data in public domain
Provide 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 validate
Frequently 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 – Pillbox
Structured Product Label (SPL)
1:many
one label, many dosage forms
Pillbox lookup table
1:1
each dosage form has single record
Derived from SPL + RxNorm
RxNorm
standardized nomenclature, innovator/generic
Eventually SPL-only

Metadata
Based on SPL
Benefit – standardized
Liability – limited OTCs, supplements
Fields
imprint, shape, color, size, score
ingredients, excipients
innovator/generic, author, DEA schedule
NDC product code, SETID

Imaging
NLM/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 Workflow
Sponsors 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 Consultants
Pharmaceutical informatics based on SPL
CEO
Surgeon
CTO
Video game designer
Photographer
Recently in the Amazon, shooting close-up images of reptiles and insects

Access – Pillbox
Research and development
Biomedical informatics
Ethnographic persona development
Information architecture
User experience
Functions
Rapid identification
Comparative review
Promotion/awareness
Health literacy
Visualization of data highlights errors
Searches for rectangle, oval, 1mm, purple

Access – Pillbox beta
Why beta?
Images have not been asserted by sponsors
Images are added to Pillbox beta once validated by NLM
Some data is from NLM
2,000 grandfathered meds, OTCs missing from SPL
NLM must generate data for missing records
Pillbox (non-beta)
All data and images derived from SPL

Access – API
API = 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 literacy
Solitaire 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 partners
Expertise
Support
Promotion
Partnership in creating a community of innovation

PillboxRestructuringStructured Product Data
David Hale, Project Manager
National Library of Medicine
National Institutes of Health
david.hale@nih.gov
301.496.3042
U.S. Pharmacopoeia Nomenclature Expert Committee
January 12, 2010

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Pillbox - Restructuring Structured Product Data

by U.S. National Library of Medicine on Jan 12, 2010

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