1 SPL Technology Presentation The Technology of Structured Product Labeling Presented by Robert H. Wallace 06 June 2004

1SPL Technology Presentation

The Technology of Structured Product Labeling

Presented by Robert H. Wallace

06 June 2004


Goals of SPL

Human-readable labeling content compatible across systems

Faster dissemination of labeling to improve risk mgmt

More efficient evaluation of labeling changes

More coordinated data collection and storage

Better support for analysis of data

Improved interoperability with other systems

Improved integration of clinical data

Improved access by prescribers and consumers

Support for retention of legacy product labeling


Creating an SPL Package Insert

To create an SPL-compliant package insert, you need the following:

Code system IDs and vocabulariesHL7FDALOINCAny additional codes

Your company’s object identifier (OID)SPL schemaImplementation guide (to put it all together)


Code Systems and OIDs

Vocabularies for SPL sections, etc. are controlled by code systems

Source organization for a code system is specified in SPL by ITU-T or ISO object identifiers (OIDs)OIDS are informative:

2 = ISO/ITU-T jointly assigned OID 2.16.840 = a US entity of some kind2.16.840.1.113883.6.1 = root identifier for LOINC

Source organizations establish code systems and vocabularies for specific domains – LOINC codes are for lab and clinical info (i.e., 34092-7 is the Clinical Studies section for an FDA Package Insert)SPL also expects the pharma’s OID on the documentSee the HL7 Data Types specification for detailed information about use of OIDs in HL7 standards


SPL Schema

Making an SPL requires the XML schema

Schema = a file defining structure, content, and organization of an XML document

SPL schema has three intermingling parts – document attributes (SPL header), structured content (SPL body structures), and narrative block (SPL body)


Document Attributes

Discrete information about the document

Identifies the type of document and its origin for storage, document management, exchange between institutions, etc.

Does not identify the product

Usually not intended for “human readability”

Each discrete piece usually consists of the content and possibly a code from a predefined code system


Document Attribute Categories

Document attribute categories for the SPL are: Document classification – All SPLs are DOCs in HL7-ese (LOINC codes)

Document identification – IDs, setIDs, version #s, type

Document time stamps – Creation date, approval date, etc.

Document confidentiality – HL7 controlled vocabulary

Document language – IETF controlled vocabulary

Author – Document author or originator (optional, but…)

Owner of Marketing Authority – Such as Lilly

Legal Authenticator – Guarantor of accuracy

Reviewer – Agency reviewer


Document Attribute Example

<author>

<time value="20030106"/>

<assignedEntity>

<id extension="PH00017" root="2.16.840.1.113883.3.933"/>

<representedOrganization>

<name>Midwestern Pharmaceuticals</name>

<addr>Metropolis, IN 46285, USA</addr>

</representedOrganization>

</assignedEntity>

</author>Identifying the package insert

source company


Structured Content

Discrete information about the product

Product information uniquely identifies the drug or biologic described in the package insert

Coded elements may stand alone or may point to text in the narrative block (in XML)

Also not intended for “human readability”

Each discrete piece usually consists of the content and a code from a predefined code system (commonly HL7, FDA, LOINC)


Structured Content Categories

Structured content categories for the SPL are: Observation – Important descriptive information about the product, like imprint code (usually controlled vocabulary)ObservationMedia – Multimedia pointer, i.e., to molecular structure graphicDrug product code – Such as NDC codePackage type, quantity – Controlled vocabularyControlled substance classification – Like DEA numberActive ingredient Active moietyInactive ingredient Labeled route of administrationProprietary name – Trade nameGeneric name – Nonproprietary name


Structured Content Example

<subject>

<manufacturedProduct>

<manufacturedLabeledDrug>

<name>Gemzar</name>

<activeIngredient>

<activeIngredientIngredientEntity>

<code code="122111-03-9" codeSystem="2.16.840.1.113883.6.61" codeSystemName=“Chemical Abstract Service"/>

<name>gemcitabine HCl</name>

</activeIngredientIngredientEntity>

</activeIngredient>

. . .

Identifying the package insert

compound


Narrative Block

Contains the actual content – text, tabular data, and graphics – that comprises a package insert

The human-readable package insert

Intended for rendering (displaying or printing) of the package insert

HL7 doesn’t require the narrative block to be in XML … but agencies can (and FDA will)

Although it’s not called structured, the narrative block still has complex mark-up


Narrative Block Markup

Narrative block markup for the SPL includes: Content – High-level “wrapper” for narrative textLink – Similar to a hypertext link on the WebDelete and insert – Indicates change from previous versionSubscript and superscriptLine break – Line control (soft break), not a paragraph markrenderMultiMedia – Place for graphic to appear in narrativeParagraphList – Ordered (numbered) or unordered (bulleted) listsTable – Modified XHTML table model (similar to Web pages)Caption – Can label any other block structure


Narrative Block Example

<component>

<section>

<id extension="a123" root="2.16.840.1.113883.3.933"/>

<code code="34089-3" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Description"/>

<title>DESCRIPTION</title>

<text>

<paragraph>Gemzar® (gemcitabine HCl) is

a nucleoside analogue that exhibits antitumor activity. <content emphasis="bold">Gemcitabine HCl </content> is

2'-deoxy-2',2'-difluorocytidine monohydrochloride (ß-isomer). . . . </paragraph>

</text>

</section>

</component>

Identifying the Description Section


Rendering

Rendering of an SPL-compliant file usually presents only the narrative block

Narrative block contains all the text we think of as “labeling”

SPL has an associated Web browser-compatible rendering as the “standard” view

SPL will have an separate browser-compatible rendering for the structured content as well


Rendering Requirements

Rendering an SPL-compliant package insert in a Web browser requires:

The SPL file itself – drugapil.xml

Files for any graphic that appears in the SPL file

The SPL stylesheet files – currently called SPL.xsl and SPL.css


Rendering Examples

Examples of labels as viewed in Microsoft Internet Explorer v. 6.0x and the draft SPL stylesheet:

Add/delete

Tables

Headings

Font effects

Lists

Graphics


Add and Delete


Tables


Headings


Headings


Font Effects


Lists


Lists


Graphics


Graphics


Addressing Issues

Modeling, Stylesheets – contact HL7 RCRIM

Can’t model a label correctly in SPL

Label as rendered in stylesheet changes the meaning of the content

HL7 Implementation Guide is inaccurate

Implementation – contact FDA

FDA-specific implementation questions (i.e., how do I send my SPL to the FDA?)


SPL - terminology

XMLA markup language used to define elements of information that can be shared among applications and organizations.

HL7Health Level 7: An ANSI-accredited standards developing organization

LOINCLogical Observation Identifiers Names and Codes: A code system managed by the Regenstrief Institute; LOINC codes serve as universal identifiers for clinical observations, including FDA package insert sections Structured Product LabelingAn HL7 standard that addresses drug product labeling markup

SPL bodyAlso called SPL narrative block, the SPL body is labeling content that visually makes up the bulk of the package insert but is not “structured” per se

SPL headerAlso called SPL document attributes, the SPL header is the “metadata” for the SPL document, denoting information about the origin of the SPL instance, such as its sender

SPL structured content Text organized according to a predefined set of rules (schema) and in which each discrete piece of content is identified according to previously established definitions (schema and code systems)

Documents

1 SPL Technology Presentation The Technology of Structured Product Labeling Presented by Robert H. Wallace 06 June 2004