# Presentation: 120639

## SPL –An Overview of the StandardJune 2004 Sandy BoyerCo-editor, SPLCo-editor, CDACo-chair, HL7 Structured Documents TCslboyer@attglobal.net

## Who I Am

- Pharmacist
- Drug information specialist
- HL7 modeler

## What Does SPL Mean?

- SPL stands for Structured Product Labeling
- “Labeling”
- vs Label
- aka Package Insert
- aka Prescribing Information
- aka Product Information
- aka Summary of Product Characteristics

## What is SPL?

- SPL is an HL7 standard
- SPL is a document markup standard that specifies the structure and semantics for the regulatory requirements and content of product labeling
- Not just for drugs
- An SPL document can include text, images, sounds, and other multimedia content
- SPL is “based on” CDA
- SPL is intended to be used as the basis for regulatory guidance documents and tooling applications for exchange of product labeling documents

## Purpose of SPL

- Facilitate provision of product labeling content both electronically and in human readable format
- Improve dissemination of product labeling
- Timeliness is critical re risk management
- Facilitate more efficient evaluation of labeling changes, section-by-section
- Promote more coordinated data collection throughout regulatory agency
- Improve processing, storage, and archiving capabilities
- Reduce or eliminate redundancies

## Purpose of SPL (cont.)

- Improve access to information and enhance ability to query and report on content of labeling
- e.g., for sub-population analysis
- Improve interoperability of regulatory agency systems with other clinical info systems
- Use standards to improve integration of data
- Enhance patient safety by improving provider access to information
- Support retention of legacy labeling

## Scope of SPL

- 	**Standardization of the markup of the content of product labeling documents for the purpose of review, editing, storage, dissemination, analysis, decision-support, and other re-use**
- SPL does not specify the creation of management of documents
- Although document management is critically interdependent, the specification of document management is outside the scope

## The Problem We’re Trying to Solve

- Authoring, updating and storage at manufacturer, regulatory agency
- Dissemination
- Re-use of labeling content; data analysis

## What is Gained By Adding Markup to Labeling Documents

- Allows us to get at the rich data that are buried in the narrative for the purpose of:
- Re-use
- Analysis (e.g., sub-population analysis)
- Clinical guidelines
- Access/portability/exchange
- query/locate by drug name, manufacturer
- Integration
- multiple products or manufacturers
- with decision support

## Why XML?

- Application independent
- Preserves human readability of documents
- Semantic markup of documents facilitates machine processability, e.g.:
- Extraction
- Storage in a database
- Re-use (including combination from multiple sources)
- Interchange
- Automation
- Re-ordering

## Adding XML markup is easy – why use information standards?

_**Interoperability**_

## Why HL7 and V3?

- Focus on healthcare
- Information model
- International open standard
- Significant international participation
- Widespread support by users, policy makers and suppliers
- Proven, consensus-based approach to development

## What is HL7?

**HL7 is a volunteer, ANSI-accredited Standards Developing Organization (SDO) that focuses on clinical and administrative healthcare data.**
**Mission:**
**"*****To provide standards for the exchange, management and integration of data that support clinical patient care and the management, delivery and evaluation of healthcare services. Specifically, to create flexible, cost effective approaches, standards, guidelines, methodologies, and related services for ******interoperability****** between healthcare information systems.*****“**
**“****Health Level Seven develops specifications, the most widely used being a messaging standard that enables disparate healthcare applications to exchange keys sets of clinical and administrative data.”**
**Website: **_[www.hl7.org](http://www.hl7.org/)_
**Phone: 734-677-7777**

## HL7 Organization

**Board of Directors – **Creates Policy
**Technical Steering Committee -- **Manages the Technical Committees
**Technical Committees (TC)**
- 		Responsible for Standards
- 		Domain TC – Creates/Sponsors Domain-Specific Standards
- 			Examples:	Orders/Observations (OO)
- 				  Financial Management (FM)
- 				  Regulated Clinical Research Information
-                                Management (RCRIM)
- 		Process TC – Provides Standards Development Environment
- 			Examples:	Modeling & Methodology
- 				  Publishing
- 				  Process Improvement
**Special Interest Groups (SIG)**
- 		Addresses Special Issues within a Domain
- 			Example:	Patient Safety SIG within RCRIM

## RCRIM (Regulated Clinical Research Information Management)

**   ****Mission **
- “The work of this committee will facilitate the development of common standards for clinical research information management across a variety of organizations -- including government agencies (FDA, CDC, NIH), private research efforts, and sponsored research -- and thus the availability of safe and effective therapies by improving the processes and efficiencies associated with regulated clinical research.”
-    **Goal**
- Develop standards for interchange of regulated data that are interoperable with general healthcare standards.

## HL7 has a number of standards to choose from – why choose CDA?

## What is CDA?

- HL7 document markup standard for **clinical documents**
**Exchange** standard (“one transformation away from exchange”)
- Permits migration to more granular markup as needed and as **technology** and **expertise** permits
- Supports **patient care**
- Ensures both **human readability** and **machine processability**
- Facilitates **integration** with other healthcare documents
- Extensive **international** acceptance

## Why is SPL Based on CDA?

- Facilitates exchange of labeling documents
- Preserves human readability while adding semantic markup and coding to facilitate machine processability of content
- Flexible structure
- Extensible to additional document types

## Labeling Requirements

- Authoring and storage
- Dissemination
- Standard format – regulations, sample package insert
- Document sections
- Coded elements
- Standard elements and figures within narrative text
- Metadata
- Modular updating, version tracking

## The Best Things About SPL

- SPL markup maintains _human readability_ while providing _machine_** **_processability_
- SPL allows scalable implementation of document markup
- SPL is flexible – e.g., doesn’t impose naming or nesting of sections
- SPL markup facilitates _exchange_ of product labeling documents
- Local tag names can be mapped to SPL
- “One transformation away from exchange”
- SPL facilitates _modular_ handling of document sections

## Using SPL allows us to bite off what we can chew

Over time, more structured data will be modeled and added (“start simple and build on that”)

There is no need to start over every time the markup gets more granular

- Over time, more structured data will be modeled and added (“start simple and build on that”)
- There is no need to start over every time the markup gets more granular

## The SPL Document

- An SPL **document** is comprisedof a **header** and a **body**

## The SPL Document

- SPL Header identifies and classifies the document and may provide information on the owner of the marketing authority, the author, legal authenticator, and reviewers
- CDA Body contains the product labeling content itself

## SPL Header – Purpose

**	****The SPL Header is constant across all SPL documents. Its purpose is to:**
- Enable product labeling storage and exchange across and within institutions
- Facilitate document management
- Set context for the rest of the document

## Structured (XML) Body

- Contains one or more sections
- Sections contain the human readable content (called the narrative block)
- Sections can contain body structures that encode content for computer processing
- Sections can contain multimedia

## The Basic Structure of SPL

**Structured Data**
**(incl. codes, references**

- The structure is flexible
- The human-readable document is preserved
- The semantics of markup come from the RIM

- Header

**Links**

**Related docs**

## Relationship Between SPL Data Elements and Narrative Block

- SPL data elements sit outside the narrative
- SPL elements can point into the narrative to which they apply

## SPL Release One Requirements

- Metadata
- Sections, e.g.:
- Boxed warning
- Indications and Usage
- Dosage and Administration
- How Supplied
- Contraindications
- Warnings
- Precautions
- Drug Interactions
- Laboratory Tests
- Pregnancy
- Nursing Mothers
- Pediatrics
- Geriatrics
- Adverse Reactions
- Overdosage
- Clinical Pharmacology
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- Coded data elements
- Descriptive information about ingredients, dosage form and packaging

## There has been unusually broad input into development of SPL and supporting materials:

- Content and technical experts within HL7 (U.S. and international)
- Industry
- Vendors
- FDA

## Development of SPL

- Involved content and technical experts
- Document analysis
- e.g., Sample PIs, Proposed Rule
- Requirements analysis
- e.g., Modular updating
- Model construction, starting with HL7 RIM
**The ballot package**
- Schemas (including data types, vocabulary, narrative block, sample)
- Specification
- Balloting
- Harmonization

## HL7 Ballot Process

- BALLOT (VOTING) PERIODS 3 TIMES PER YEAR
- BALLOT RECONCILIATION
- 	**All negatives addressed**
- NORMAL BALLOT PROGRESSION
- 	Each Standard is first balloted at “Committee Level”
- Reballoted at committee level until passed with no substantive changes
- 	Each Standard then balloted at “Membership Level”
- 		Higher hurdle for passage
- Reballoted at membership level until passed with no substantive changes
- 	Standard submitted to ANSI as an HL7 Standard

## Status

- HL7
- SPL has completed HL7 membership level ballot
- Stylesheet development
- Implementation Guide development
- Regulatory
- Final rule re submission of labeling in electronic format – Federal Register, December 11, 2003
- Draft guidance re use of SPL for content of labeling – Federal Register, February 5, 2004

## What’s Next?

**Structured Data**
**(incl. codes, references**

- Header

**Links**

**Related**** ****docs**

**Related Documents**

**What’s Next?**

**Highlights Section and . . **

## Over time, more structured data will be modeled and added (“start simple and build on that”)

There is no need to start over every time the markup gets more granular

- There is no need to start over every time the markup gets more granular

## For More Details

- Latest working draft of CDA; minutes of meetings; other documents
- Structured Documents Technical Committee page on HL7 web site (_[www.hl7.org](http://www.hl7.org/)_)
- SPL and CDA ballots and other HL7 V3 ballots
- _[www.hl7.org](http://www.hl7.org/)_

## An Invitation

- How to get involved:
- SPL:
- PhRMA working group (Kris Spahr)
- Contact editor (Sandy Boyer)
- HL7 RCRIM Technical Committee listserv
- CDA teleconferences
- HL7 listservs and meetings (see _[www.hl7.org](http://www.hl7.org/)_)

## <?Q &amp; A?>

**...thank you**
**for your**
**time**
**(and your interest)**