HL7 Standards Product Brief – HL7 Version 3 Standard: Structured Product Labeling, Release 4





Section 3: Clinical and Administrative Domains







DESCRIPTION


The HL7 Version 3 Structured Product Labeling (SPL) specification is a document markup standard that specifies the structure and semantics of the content of authorized published information that accompanies any medicine licensed by a medicines licensing authority. An SPL document is created by an organization that is required by law to submit product information document because it is responsible for the creation or marketing of a product, or any other person or organization compelled by other motives to submit information about products, whether originally created or not. This includes original manufacturers, repackagers, relabelers, and public agencies or private information publishers that submit product information documents. Recipients of product label documents are any person or organization, including the public at large, or an agent of the public (such as a regulatory authority).


ALTERNATIVE NAMES

HL7 Version 3 Standard: Structured Product Labeling, Release 4 may also go by the following names or acronyms:


“Structured Product Labeling, R4”, SPL


TARGETS


  • Pharmaceutical Companies

  • Veterinary Drug Product Companies

  • Biologic Drug Companies

  • Producers of Bulk Drug Products

BENEFITS


  • Facilitates 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.

  • Improves 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.

  • Facilitates 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.

  • Promotes more coordinated data collection throughout the regulatory agency and improve processing, storage and archiving capabilities. Reduce or eliminate redundancies in data collection.

  • Improves 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 differences in products based on gender, race, age, and geographic location.

  • Improves interoperability of the regulatory agency’s systems with other clinical information systems

  • Uses standards to improve integration of clinical data

  • Enhances 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.

  • Supports retention of legacy product labeling in databases

IMPLEMENTATIONS/CASE STUDIES


See the Implementation Guide for this Standard.


  • More than 22,000 FDA approved labels (package inserts)

DEVELOPMENT BACKGROUND


  • The need to create SPL documents is typically governed by legal statutes which set points such as the completion of a new drug application (NDA), the change of product information or annual reports as requiring submission of an SPL document. This Implementation Guide provides technical conformance criteria for SPL files based on the drug establishment registration and drug listing process at the United States Food and Drug Administration (FDA). Information on electronic submission may be found in guidance entitled Providing Regulatory Submissions in Electronic Format – Establishment Registration and Drug Listing.



SPL documents are known as “product label,” “package insert,” “prescribing information,” “product information,” “medicines information,” and many other names. SPL is mandated in the US for;


(a) submitting content of labeling with marketing applications and supplements thereto for human prescription drugs and some biological products, and

(b) for electronic Establishment Registration and Product Listing for all listed human prescription drugs (including compressed medical gasses), over the counter human drugs (including some cosmetics containing drug substances), biological products and animal health products.



SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (including drug listing data elements and clinical data elements). Drug listing data elements include coded information about the product (including product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type). Clinical data elements include coded information about the clinical use of the product (including indications and use, contraindications, drug interactions, warning and precautions and use in special populations).



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.

RESPONSIBLE WORK GROUP




RELATED DOCUMENTS
















HL7 Version 3 Standard: Structured Product Labeling, Release 4







(Download)

(3.66 MB)




HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 1


(View Brief)






(Download)

(895 KB)




HL7 Version 3 Standard: Structured Product Labeling, Release 1


(View Brief)






(Download)

(2.72 MB)




HL7 Version 3 Standard: Structured Product Labeling, Release 2


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(3.78 MB)




HL7 Version 3 Standard: Structured Product Labeling, Release 3


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Structured Product Labeling (SPL) in the Clinical Environment – Presentation (2010)


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(3.85 MB)






IMPLEMENTATION GUIDES




ADDITIONAL DETAILS


For specifications and information about workgroups, training, projects and more, visit the

HL7 Wiki page for this product at:


http://wiki.hl7.org/index.php?title=Structured_Product_Labeling



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