Structured Product Label (SPL)
We have designed the Structured Product Label (SPL) specification, an HL7 standard for medicinal product knowledge in both human readable and computer-interpretable format. SPL is the first comprehensive standard of medicinal products and is implemented by the U.S. FDA and all U.S. pharmaceutical industry.
Figure 1: The SPL model is a realist
ontology of medical products, therefore it can represent the contents of the
NDF-RT itself (Right). This project will focus on detailing the Mechanism of
Action (MoA) annotation.
standard is one of many applications of the HL7 RIM. It is a knowledge
representation standard for drug products. Prior to SPL there was no data
standard for medication knowledge (outside of proprietary products) able to
express even the basic realities of medicines, ingredients and packaging in a
computable way. All pharmaceutical manufacturers in the U.S. submit
drug information to the FDA using SPL and the NLM publishes them online. The SPL knowledge base presently contains
over 3200 descriptions of currently marketed drugs. SPL, which includes data
relevant for clinical decision support such as adverse effects,
contraindication, interactions, and monitoring requirements, serves as
preliminary evidence that it is indeed possible to integrate medical knowledge
into a standard which was driven by practical health information systems. Within
the SPL structure all the terminologies of the U.S. federated medication
terminology system come together: the NDC product code, Unique Ingredient
Identifier (UNII), SNOMED CT disease / finding concepts, the VA NDF-RT system’s
ChemicalStructure classes (originating in the NLM MeSH system), physiologic
effect and the mechanism of action terms (described in detail below). SPL also
combines several smaller vocabularies from the NCI Thesaurus and the Unified
Code for Units of Measure.