Product SPL

Product Brief - SPL

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Product Name

Structured Product Labeling (SPL)

Standard Category

Health Information Knowledge Representation Standards

Type

Normative, ANSI Standard

Releases

• ANSI/HL7 SPL, R1-2004
• ANSI/HL7 V3 SPL, R2-2005
• ANSI/HL7 V3 SPL, R3-2007
• ANSI/HL7 V3 SPL, R4-2009

Summary

The Structured Product Labeling (SPL) specification is a document markup standard that specifies the structure and semantics for the regulatory requirements and content of product labeling. Like most documents, an SPL document has sections and sections contain text (paragraphs, lists, tables); SPL documents can be rendered and published in these standard narrative presentations. At the same time, the SPL specification provides semantic markup that permits extraction of relevant data embedded in the narrative so that it can be used for other purposes. In other words, SPL markup of a product labeling document preserves both the human readability of the content and facilitates machine processing of that content.

Structured Product Labeling (SPL) defines the content of human prescription drug labeling in an XML format. This format is defined within the SPL schema and is displayed in a web browser using the SPL stylesheet. It is approved by Health Level Seven (HL7) and has been adopted by FDA as a mechanism for exchanging medication information. (from Wikipedia)

Description

SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (drug listing data elements). Drug listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

This specification includes a detailed description of an information model for structured product labeling documents as well as the XML representation of that model. The information model is based on the HL7 Reference Information Model (RIM) and uses the HL7 Version 3 Data Types. SPL is based on the HL7 Clinical Document Architecture (CDA), which specifies the structure and semantics of “clinical documents” for the purpose of exchange (see 3.1.1 Relationship of the SPL Specification to CDA). The SPL Schema is defined as an XML entity. An SPL document references the SPL Schema.

For this version of the specification, document analysis focused primarily on labeling for drug products. In the U.S. or internationally, drug product labeling may also be known variously as a package insert, prescribing information, product information, or summary of product characteristics, among others. The precise definition and content of product labeling may also vary depending on the country. (For example, in the U.S., all written, printed, or graphic matter accompanying a drug product is called “labeling”. For human prescription drugs, the “content of labeling” includes all text tables and figures in the labeling described in 21CFR 201.57.) Implementers of this standard should refer to applicable regulations and definitions in the realm in which the standard will be used.

THE PURPOSE OF THE SPL

The major purpose of the SPL specification is to facilitate the review, editing, storage, dissemination of, and access to, product labeling document content. It is intended to:

• Facilitate provision of the content of product labeling both electronically and in a human readable format. SPL documents can be exchanged across systems without the need for additional transformation steps.
• Improve dissemination of product labeling (both new product labeling and product labeling updates) to users of product labeling. The ability to provide the most up- to-date product labeling in a timely manner is considered to be critical to improving risk management of regulated products.
• Facilitate more efficient evaluation of labeling changes by allowing more effective use of computer technology to compare different versions of labeling on a section by section basis.
• Promote more coordinated data collection throughout the regulatory agency and improve processing, storage and archiving capabilities. Reduce or eliminate redundancies in data collection.
• Improve access to information and enhance the ability to query and report on the content of labeling, allowing better support for specific analyses such as sub-population assessments of differ- ences in products based on gender, race, age, and geographic location.
• Improve interoperability of the regulatory agency’s systems with other clinical information systems.
• Use standards to improve integration of clinical data.
• Enhance patient safety by helping to provide prescribers and consumers with improved access to information needed to make better risk management decisions in a format that will enhance integration with other technical and clinical applications.
• Support retention of legacy product labeling in databases.

In general, this specification shares the goals of the CDA, which are to:

• Give priority to delivery of patient care.
• Allow cost effective implementation across as wide a spectrum of systems as possible.
• Support exchange of human-readable documents between users, including those with different levels of technical sophistication.
• Promote longevity of all information encoded according to this architecture.
• Enable a wide range of post-exchange pro- cessing applications.
• Be compatible with a wide range of document creation applications.
• Promote exchange that is independent of the underlying transfer or storage mechanism.
• Prepare the design reasonably quickly.
• Enable policy-makers to control their own information requirements without extension to this specification.

Although SPL does not give priority to delivery of patient care in the same way as CDA documents, which are directly associated with patient encounters, the goal of providing timely information about medical products ultimately serves patient care.

Additional goals of the SPL specification include:

• Facilitate review, storage, and dissemination of product labeling.
• Maximize timeliness of availability of product labeling.

The most recent version, Release 4, received ANSI approval in March 2009 and extends the SPL standard to include medical devices, veterinary medicine, and additional listing information. It is available for purchase at the HL7 bookstore at www.HL7.org.

Benefits

The benefits that accrue to all stakeholders in the drug regulatory process by adoption of Structured Product Labeling (SPL) make the business case for implementation of SPL overwhelming. The benefits of SPL derive from use of standard, universally adopted information standards such as XML, from the specific aspects of the SPL model for describing prescription drug content, and from adoption of an open standard for SPL. (from FDA Publication, see Appendices)

Implementations/ Case Studies (Actual Users)

US FDA

Resources

• SPL Project Wiki
• SPL Work Group Wiki

Work Groups

• RCRIM WG

Education

• See more at http://hl7new.amg-hq.net/implement/training.cfm

Certification Available

• none