Pillbox at US Pharmacopeia's Annual Scientific Meeting
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Transcript of Pillbox at US Pharmacopeia's Annual Scientific Meeting
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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
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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
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Origins
• National Library of Medicine/NIH
• Center for Drug Evaluation and Research/FDA
• Poison Control Centers
• Department of Veterans Affairs
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• 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
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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
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Pillbox lookup table v1
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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
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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
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Pillboxhttp://pillbox.nlm.nih.gov
David Hale, Project [email protected]
National Library of MedicineNational Institutes of HealthU.S. Department of Health and Human Services