HL7 Version 3 Standard: Structured Product Labeling, Release 5

DESCRIPTION

SPL release 5 (normative) is an extension of the previous releases of SPL, that all received extensive use in production, especially the releases 1, 3, 4, and 5 (DSTU). In addition to labeling submissions, SPL has been used since 2009 for registering and listing of all drug products legally marketed in the US. Beginning in 2014, Medical Device Labelers will be required to submit device identification information for medical devices commercially distributed in the US. These requirements can be met using submissions that have been formatted in the SPL standard.

ALTERNATIVE NAMES

HL7 Version 3 Standard: Structured Product Labeling, Release 5 may also go by the following names or acronyms:

TARGETS

• Regulatory Agency
• EHR, PHR Vendors
• Health Care IT Vendors
• Pharmaceutical Companies
• Veterinary Drug Product Companies
• Biologic Drug Companies
• Producers of Bulk Drug Products

BENEFITS

• Enables manufacturers of regulated products to electronically exchange information with regulators
• 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

• Implementers include the FDA Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiologic Health (CDRH)
• 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.

RELATED DOCUMENTS

	HL7 Version 3 Standard: Structured Product Labeling, Release 5		(Download) (241.41 MB)
	HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 1	(View Brief)	(Download) (895 KB)
	HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 3: FDA Content of Labeling	(View Brief)	(Download) (232 KB)
	HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 4	(View Brief)	(Download) (235 KB)
	HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 5	(View Brief)	(Download) (262 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	(View Brief)	(Download) (3.78 MB)
	HL7 Version 3 Standard: Structured Product Labeling, Release 3	(View Brief)	(Download) (2.25 MB)
	HL7 Version 3 Standard: Structured Product Labeling, Release 4	(View Brief)	(Download) (3.66 MB)
	Structured Product Labeling (SPL) in the Clinical Environment - Presentation (2010)	(View Brief)	(Download) (3.85 MB)

ADDITIONAL DETAILS

SPL release 5 is an extension of the SPL release 4 content to cover more details of medical devices.

Most importantly, however, SPL R5 is the first release to rely on the Common Product Model (CPM) for its product data elements content.

TOPICS

• Regulated Products
• SPL

BALLOT TYPE

• Normative

STATUS DATE

RESPONSIBLE WORK GROUPS

STAKEHOLDERS

• EHR, PHR Vendors
• Health Care IT Vendors
• Regulatory Agency

FAMILY

• V3

CURRENT STATE

• Retired

REALM

• Universal