Linked-spls-initial-hcls-presentation-06082012
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Transcript of Linked-spls-initial-hcls-presentation-06082012
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Biomedical Informatics1
Linked Structured Product Labels (LinkedSPLs) -Towards a reference linked data source for drug product labeling
Richard Boyce, University of Pittsburgh
Department of Biomedical Informatics
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Biomedical Informatics2
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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Biomedical Informatics3
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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Biomedical Informatics4
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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Biomedical Informatics5
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.pdf2. http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm3. http://dailymed.nlm.nih.gov/dailymed/downloadLabels.cfm
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Biomedical Informatics6
Want to see one?• Perphenazine and Amitriptyline HCL:
– http://tinyurl.com/d93ttm5
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Biomedical Informatics7
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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Biomedical Informatics8
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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Biomedical Informatics9
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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Biomedical Informatics10
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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Biomedical Informatics11
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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Biomedical Informatics12
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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Biomedical Informatics13
Use Case 11. 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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Biomedical Informatics14
Use Case 21. 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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Biomedical Informatics15
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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My initial effort at provenanced2r: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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Biomedical Informatics17
Discussion/questions
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Biomedical Informatics18
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