Use Case 45: Formatting on structured product labels
From Demand-Driven Open Data for HHS
Use case summary
- Title: Formatting on structured product labels
- Work item: https://github.com/demand-driven-open-data/ddod-intake/issues/45
- This use case is a split off from use case #25
|[Go to Use Case #25 History for Structed Product Labels page] ➡|
- OpenFDA API response is missing HTML formatting markers, such as line breaks
- OpenFDA API response sometimes merges together versions of the "Indications and Usage" section from the "Highlights of Prescribing Information" and the "Full Prescribing Information" sections
- Value to customer: HTML formatting markers would increase readability of openFDA API response
- Value to industry/public: ___
Current data and limitation
- Data source: openFDA Label API
- How it's used: ___
- Limitations: ___
Current status of Open FDA
Human readable formatting
- Human readable HTML formatting on labels is embedded in the XML files available for download.
- The SPL Implementation Guide describes the formatting included as...
- "The human readable text content of SPL documents is contained within the <text> element. The actual content is contained within a <paragraph>, <table>, and/or <list>. If a section consists only of nested sections, the <text> tag is not included. Elements that can be used within the <text> element to capture the human readable content of SPL include paragraphs (<paragraph>), lists (<list>), tables (<table>) and images (<renderMultimedia>). Elements permitted as children of the <text> element, used as children of the <paragraph> element or within <table> and <list> include superscripts (<sup>), subscripts (<sub>), links (<linkHtml>), line breaks (<br>), footnotes (<footnote>), footnote references (<footnoteRef>). Images may be included in the content of labeling using the <renderMultiMedia> tag. This tag may be used as a direct child of <text> for ‘block’ images or as a child of <paragraph> for inline images."
- Fields: _______
- Update frequency: _______
- Joins between datasets: _______
- Lag time: _______
- History: _______
- Delivery mechanism: _______
Short term workaround
- openFDA may be accurately presenting the the "Indications and Usage" data and that the original formatting is the issue per Information for Healthcare Professionals on FDA's New Prescribing Information for Drugs "New Look"
Long term implementation
Human readable formatting
Human readable HTML formatting on labels:
- As of 6/25/2015, there's not estimated commitment date yet.