PillboxPharmaceutical Imaging, Identification, and Referencehttp://pillbox.nlm.nih.govNational Library of MedicineNational Institutes of HealthU.S. Dept. of Health and Human ServicesDavid Hale, Project Managerdavid.hale@nih.gov301.496.3042

OverviewConnecting 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

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

OriginsNational Library of Medicine/NIHCenter for Drug Evaluation and Research/FDAPoison Control CentersDepartment of Veterans Affairs

National Library of Medicine/NIH

Center for Drug Evaluation and Research/FDA

Poison Control Centers

Department of Veterans Affairs

NLM/FDAReference/PatientSafetyInitiativeWorking with imaging expertsSet standards for consistent high-quality images Hosting images at NLMSPL already being hosted through DailyMedPrototype images shot at VA CMOPPilot project (Fall 2009)Public domain resourceScalable/portable framework

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

Acquisition AnalysisApplicationFDA Structured Product Label (SPL)SPLCOLORSPLIMPRINTSPLSHAPESPLSIZESPLSCOREDEA_SCHEDULEINGREDIENTSEXCIPIENTSSPONSORSETID, NDC…RxNormStandardized ingredient listingProduct CodeNDC9RXCUIRXTTYRXSTRINGRapid Identification of UnknownsInformation ProvisionDrug Information PortalDailyMedPubMedMedlinePlusNLM-generated metadataUser Interface designSearch experienceRelevancy rankingFuzzy logicNLM Image Acquisition and AnalysisSegmentationFrame registrationSub-mm measurementsLAB color spaceK-means clustering

Pillbox lookup table v1

Dialogue with ManufacturersSponsor submission of images to SPL for reference and enhancing patient safetyLogistics/sustainabilityAcquiring samples and imagingManufacturers verifying images and submitting image for inclusion with SPLIncorporate digital imaging currently performed by sponsorsEnhance accuracy of SPL

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, MDFDA call for voluntary submission of samples6 samples of each solid dosage formNLM will provide SPL-ready images AND master high-resolution imagesSponsor submission of SPLIMAGEHHS/ASPR disposal of samples

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.govDavid Hale, Project Managerdavid.hale@nih.gov301.496.3042National Library of MedicineNational Institutes of HealthU.S. Department of Health and Human Services