Pillbox - Restructuring Structured Product Data

Pillbox

RestructuringStructured Product Data

David Hale, Project ManagerNational Library of MedicineNational Institutes of Health

[email protected]

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

[email protected]

U.S. Pharmacopoeia Nomenclature Expert CommitteeJanuary 12, 2010

Pillbox - Restructuring Structured Product Data

Health & Medicine

Transcript of Pillbox - Restructuring Structured Product Data