1 / 15

Overview of DailyMed: Structured Product Labeling and Data Workflow

This presentation by John Kilbourne, MD, highlights DailyMed as a key resource for structured product labeling (SPL). DailyMed serves as an authoritative source of drug data, showcasing the collaborative workflow between the FDA and the National Library of Medicine (NLM). It details the data flow process, including validation checks and publishing formats for SPLs. The service also provides various web services for accessing SPLs based on NDC and drug names. Future enhancements include patient-level information and integration of MedWatch data.

denver
Télécharger la présentation

Overview of DailyMed: Structured Product Labeling and Data Workflow

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Overview of DailyMed John Kilbourne MD National Library of Medicine kilbourj@mail.nlm.nih.gov

  2. Structured Product Label (SPL) • Significant and authoritative source of data • Practical demonstration of FDA-NLM workflow cooperation • Primary data source for RxNorm

  3. http://dailymed.nlm.nih.gov/

  4. Diazepam Label on DailyMed

  5. Data Flow: Path of data for SPL

  6. DailyMed File Processing

  7. DRN File

  8. DRN Validation Checks ZIP file exists ZIP file name follows correct format ZIP file contains only one XML file XML file passes SPL schema validation SPL has valid version number All images referenced by SPL exist

  9. Files Published Online • HTML • PDF • XML • ZIP

  10. Unique Ingredient Identifier (UNII)

  11. Drug Class Indexing

  12. Drug Classes Displayed

  13. Current Web Services • Returns a list of all SPLs with the given NDC. • Returns imprint data associated with the given NDC. • Returns a list of all SPLs with the given drug name. Much broader set of web services planned for late 2013 / early 2014.

  14. Other Facts • Drug data published ‘as is’ • Archived labels, billing unit data • Medwatch data being incorporated • Substance indexing files (mol files) • Patient level information may be forthcoming

  15. Thank you John Kilbourne MD kilbourj@mail.nlm.nih.gov

More Related