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SPLIMAGE Portal

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The SPLIMAGE portal can help the pharmaceutical industry obtain files of images of their prescription pills that meet recommended SPL image guidelines. The guidelines were developed in collaboration with the U.S. Food and Drug Administration (FDA). The portal was developed in consultation with the FDA.

In broad outline, using the portal is a two-part process (details are at the instructions for using the SPLIMAGE portal):

  • After initial correspondence between the participant – defined below – and NLM, the participant sends pills to NLM’s imaging facility.
  • NLM takes digital photographs of those pills, creates files of images of those pills that meet the guidelines, and adds those files to the SPLIMAGE database, from which the participant can retrieve them.

TERMINOLOGY USED IN THIS DOCUMENTATION

  • OSDFs are oral solid dose formulations, also known as pills, and are “capsules, tablets, or similar drug products intended for oral use”[1].
  • Participants are pharmaceutical manufacturers, private-label distributors, re-packagers, wholesalers, and retail and institutional pharmacies that have completed their response to Federal Register Notice 79 FR 56381 entitled “Call for Participation for Computational Photography Project for Pill Identification (C3PI)”. Only participants can use the SPLIMAGE portal.
  • SPL stands for Structured Product Labeling, “a document markup standard approved by Health Level 7 (HL7) and adopted by FDA as a mechanism for exchanging product and facility information”[2].

HOW PARTICIPANTS CAN USE THE SPLIMAGE PORTAL AND ITS IMAGE FILES

  • Participants can include image files from the SPLIMAGE portal along with SPL documents that they submit to the FDA for approval.
  • Participants can generate both printed patient inserts that come with prescription drugs and on-line prescription drug descriptions from SPL documents and images from the SPLIMAGE portal.
  • Participants can search for images in the SPLIMAGE database.
  • Participants can use the portal and access the SPLIMAGE database free of charge.
  • Participants are not required to use the SPLIMAGE portal, but rather can create files of images of their OSDFs on their own.

DIFFERENCES BETWEEN IMAGES IN THE SPLIMAGE DATABASE AND IMAGES IN THE RxIMAGE DATABASE

The RxIMAGE database is a curated, increasingly comprehensive database of OSDF images and associated data. The “views” of the fronts and the backs of pills are the same in the RxIMAGE database and the SPLIMAGE database. However, in images in the RxIMAGE database, the background includes an NLM watermark, and other characteristics are different from images in the SPLIMAGE database. Consequently, images in the RxIMAGE database do not meet the guidelines.

The RxIMAGE API is an Application Programming Interface for searching for and retrieving images and data from the RxIMAGE database. The RxIMAGE API is freely accessible. The images and data that the API retrieves are freely available.

THE PARENT PROJECT: C3PI (COMPUTATIONAL PHOTOGRAPHY PROJECT FOR PILL IDENTIFICATION)

The SPLIMAGE portal, SPLIMAGE database, and SPL image guidelines, and the RxIMAGE API and RxIMAGE database, are part of the Computational Photography Project for Pill Identification. C3PI is a research and development project in NLM/LHNCBC’s Office of High Performance Computing and Communications (OHPCC). OHPCC appreciates the high quality RxIMAGE and SPLIMAGE imaging and database work being done by Medicos Consultants LLC under contract to OHPCC.

The objectives of the portal, guidelines, API, and databases together are to (1) improve the prescription drug information made available to health care providers and consumers, and (2) build a freely accessible database of freely available images and associated data for all prescription OSDFs marketed in the United States.

COMMENTS

Comments and suggestions are welcome at splimage@nlm.nih.gov.

[1] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=206.3

[2] http://www.fda.gov/forindustry/datastandards/structuredproductlabeling/default.htm