An introduction to the Linked Structured Product Label (LinkedSPL) resource for the W3C Health Care and Life Sciences Linking Open Drug Data task force. LinkeSPLs (purl.org/net/nlprepository/linkedSPLs) publishes selected sections of FDA-approved drug package inserts from DailyMed for use by NLP and Semantic Web researchers. Currently, only data from the product labels of prescription drugs is provided. This site's SPL data is updated weekly and all SPLs retain DailyMed versioning data so that researchers can record the provenance of the text and sections they work with. LinkedSPLs is provided as a service as part of the Drug Interaction Knowledge Base (DIKB) project

1. Linked Structured
Product Labels
(LinkedSPLs) -
Towards a reference
linked data source for
drug product labeling
Richard Boyce, University of Pittsburgh
1 Biomedical Informatics
Department of Biomedical Informatics

2. Overview
• About product labels
• What are Structured Product Labels
• Some use cases
• Linked DailyMed was a great start
• How LinkedSPLs is an improvement
• Some best practices used and needed
• Discussion
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3. Why are product labels important?
• Product labels are intended to be a reference for
prescribing clinicians [1]
1. Marroum PJ, Gobburu J. The product label: how pharmacokinetics and
pharmacodynamics reach the prescriber. Clin Pharmacokinet. 2002;41(3):161-169.
2. Ko, Y. et al. Prescribers’ knowledge of and sources of information for potential drug-
drug interactions: a postal survey of US prescribers. Drug Saf. 31, 525-536 (2008).
3. Boyce RD, Collins C, Clayton M, Kloke J, Horn J. Inhibitory Metabolic Drug
Interactions with Newer Psychotropic Drugs: Inclusion in Package Inserts and
Influences of Concurrence in Drug Interaction Screening Software. Annals of
Pharmacotherapy. (In Press).
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4. Why is the product label apparently
so influential?
• Authoritative
• Simple (for a drug expert) to follow
• Often the only source of information besides
FDA approval documentation for new drugs
• No standard for searching the scientific
literature
• No standard for judging the quality of
published studies
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5. Structured Product Labels (SPL)
• All package inserts for currently marketed drugs
are available in this format [1-3]
1. http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2005-N-0464-gdl.pdf
2. http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
3. http://dailymed.nlm.nih.gov/dailymed/downloadLabels.cfm
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6. Want to see one?
• Perphenazine and Amitriptyline HCL:
– http://tinyurl.com/d93ttm5
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7. FDA dictates the kinds of claims that
should be present in each section [1]
1. FDA. Code of Federal Regulations 21 Part 201.56, chapter Requirements on content and format of labeling for human prescription drug and biological
products. Washington, DC: US Government Printing Office, 2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.57
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8. DailyMed – the public source of
SPLs
• dailymed.nlm.nih.gov/
• Provides an HTML view of SPLs using XSLT
• Current statistics:
– Human prescription products: ~17K
– Human OTC: ~16K
– Homeopathic: ~3K
– Animal: 1k
– Other: ~500
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9. DailyMed uses Permanent URLs
"SPL IDs are not static, so a label's URL may change if
the label is updated. However, we provide permanent
URLs to view or download the latest version of an SPL”
• a permanent URL to view a label.
– http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid={setId}
• a permanent URL to download a label as a ZIP file.
– http://dailymed.nlm.nih.gov/dailymed/downloadzipfile.cfm?setI
d={setid}
• Try it for setid ‘ca5598e4-4226-45ab-abd1-e961707ae457’
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10. SPLs on the Semantic Web 1/2
• The DailyMed node:
– http://www4.wiwiss.fu-berlin.de/dailymed/
– 164,276 triples; 4,039 drugs (http://tinyurl.com/6qzd2lo)
• A great start but…
– does not appear to handle drug products with more
than one active ingredient correctly
– clearly incomplete
– incorrect encoding (Latin instead of Unicode)
– how often is it updated and where is the versioning
information?
– where are the HTML tables and Image tags?
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11. SPLs on the Semantic Web 2/2
• The LinkedSPL node:
– http://purl.org/net/nlprepository/linkedSPLs
– 527K triples; 17K drugs
– Active ingredients linked to ChEBI (via dc:subject)
• Also, links to DrugBank (706) and bio2rdf (1412) via dailymed:subjectXref
• Some improvements now implemented
– correctly handles drug products with more than one active
ingredient
– Complete for prescription drugs
– correct encoding
– updated weekly and versioning information present
– HTML tables and Image tags retained in raw form
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12. Goals for LinkedSPLs
• I want this the resource to:
1. be a model of best practices for publishing
linked open drug data in terms of
provenance, data quality, and timeliness
2. Become the reference linked data source
for drug product labels for the NLP and
Semantic Web communities
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13. Use Case 1
1. An NLP researcher developing an
algorithm for extracting entities or
knowledge from the product label
– May require only a particular section or set of
sections
– Would like to stratify sampling of the product
labels by product and drug features
• E.g., drug class, drug targets, pharmacokinetic
properties, manufacturer, date of first release
– The training data represents knowledge that
is most useful if linked back to the SPL
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14. Use Case 2
1. A Semantic Web researcher wants to link
to product labeling
– May require only a particular section or set of
sections
– Wants to enable querying of the product
labels by product and drug features
• E.g., drug class, drug targets, pharmacokinetic
properties, manufacturer, date of first release
– Data quality and provenance important
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15. Some best practices used and
needed
• PURLs not yet fully implemented
– Makes for long URIs and server dependance
• Some initial use of provenance meta-data
– See next slide
• Revision history not yet implemented
– Can be derived from DailyMed RSS feed
• Not sure of all of the NLP and SW community
requirements
• Looking for collaborators
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16. My initial effort at provenance
d2r:documentMetadata [
foaf:primaryTopic <http://purl.org/net/nlprepository/linkedSPLs>;
meta:d2rUser "Richard D. Boyce";
meta:d2rUserHomepage <http://www.linkedin.com/in/boycer>;
meta:d2rOperator "Richard D. Boyce";
meta:license <http://creativecommons.org/licenses/by-nc-sa/3.0/>
;
meta:dataset <http://thedatahub.org/dataset/linked-structured-
product-labels>;
prv:performedAt "2012-04-10T12:00:00Z"^^xsd:dateTime;
prv:performedBy <http://www.linkedin.com/in/boycer>;
rdfs:comment "Please note that DailyMed updates
(http://dailymed.nlm.nih.gov/dailymed/rss.cfm) are brought into the
LinkedSPL resources once per week.";
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17. Discussion/questions
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18. Acknowledgements
• The Drug Interaction Knowledge Base team
– John Horn Pharm.D, Carol Collins MD, Greg
Gardner, Rob Guzman
• W3C LODD and Scientific Discourse Task
Force
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