Pillbox at US Pharmacopeia's Annual Scientific Meeting

PillboxPharmaceutical Imaging, Identification, and Reference

National Library of MedicineNational Institutes of HealthU.S. Dept. of Health and Human Services

David Hale, Project [email protected]

301.496.3042

http://pillbox.nlm.nih.gov

Overview

• Connecting high-quality images of solid-dosage forms with the SPL (SPLIMAGE)

• Initiating a pilot project to create a library of images of Rx, solid-dosage forms (U.S. market)

• Creating a system for comparative review/rapid identification

Origins

• National Library of Medicine/NIH

• Center for Drug Evaluation and Research/FDA

• Poison Control Centers

• Department of Veterans Affairs

• Working with imaging experts• Set standards for consistent high-quality images

• Hosting images at NLM• SPL already being hosted through DailyMed

• Prototype images shot at VA CMOP• Pilot project (Fall 2009)• Public domain resource• Scalable/portable framework

NLM/FDAReference/Patient Safety Initiative

Acquisition Analysis ApplicationFDA Structured Product Label (SPL)

SPLCOLORSPLIMPRINTSPLSHAPESPLSIZESPLSCOREDEA_SCHEDULEINGREDIENTSEXCIPIENTSSPONSORSETID, NDC…

RxNorm

Standardized ingredient listingProduct CodeNDC9RXCUIRXTTYRXSTRING

NLM Image Acquisition and Analysis

SegmentationFrame registrationSub-mm measurementsLAB color spaceK-means clustering

NLM-generated metadata

User Interface designSearch experienceRelevancy rankingFuzzy logic

Information Provision

Drug Information PortalDailyMedPubMedMedlinePlus

Rapid Identification of Unknowns

Pillbox lookup table v1

Dialogue with Manufacturers

• Sponsor submission of images to SPL for reference and enhancing patient safety

• Logistics/sustainability• Acquiring samples and imaging• Manufacturers verifying images and submitting

image for inclusion with SPL• Incorporate digital imaging currently performed

by sponsors

• Enhance accuracy of SPL

Pilot Project (Fall 2009)

• NLM imaging at FDA facility, Rockville, MD• FDA call for voluntary submission of

samples• 6 samples of each solid dosage form

• NLM will provide SPL-ready images AND master high-resolution images

• Sponsor submission of SPLIMAGE• HHS/ASPR disposal of samples

Pillboxhttp://pillbox.nlm.nih.gov

David Hale, Project [email protected]

National Library of MedicineNational Institutes of HealthU.S. Department of Health and Human Services