Transcript New technical requirements for Labeling

The Technology of
Structured Product Labeling
Presented by Robert H. Wallace
06 June 2004
SPL Technology Presentation
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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
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Creating an SPL Package Insert
To create an SPL-compliant package insert, you
need the following:
Code system IDs and vocabularies
HL7
FDA
LOINC
Any additional codes
Your company’s object identifier (OID)
SPL schema
Implementation guide (to put it all together)
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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 kind
2.16.840.1.113883.6.1 = 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 document
See the HL7 Data Types specification for detailed
information about use of OIDs in HL7 standards
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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)
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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
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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
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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>
SPL Technology Presentation
Identifying the
package insert
source company
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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)
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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 graphic
Drug product code – Such as NDC code
Package type, quantity – Controlled vocabulary
Controlled substance classification – Like DEA number
Active ingredient
Active moiety
Inactive ingredient
Labeled route of administration
Proprietary name – Trade name
Generic name – Nonproprietary name
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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>
...
SPL Technology Presentation
Identifying the
package insert
compound
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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
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Narrative Block Markup
Narrative block markup for the SPL includes:
Content – High-level “wrapper” for narrative text
Link – Similar to a hypertext link on the Web
Delete and insert – Indicates change from previous
version
Subscript and superscript
Line break – Line control (soft break), not a paragraph
mark
renderMultiMedia – Place for graphic to appear in
narrative
Paragraph
List – Ordered (numbered) or unordered (bulleted) lists
Table – Modified XHTML table model (similar to Web
pages)
Caption – Can label any other block structure
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SPL Technology Presentation
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&#174; (gemcitabine HCl) is
a nucleoside analogue that exhibits antitumor activity. <content
emphasis="bold">Gemcitabine HCl </content> is
2'-deoxy-2',2'-difluorocytidine monohydrochloride (&#223;-isomer). . . .
</paragraph>
</text>
</section>
</component>
SPL Technology Presentation
Identifying the
Description Section
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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
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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
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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
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Add and Delete
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Tables
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Headings
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Headings
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Font Effects
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Lists
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Lists
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Graphics
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Graphics
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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?)
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SPL - terminology
XML
A markup language used to define elements of information that can be shared among applications
and organizations.
HL7
Health Level 7: An ANSI-accredited standards developing organization
LOINC
Logical 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 Labeling
An HL7 standard that addresses drug product labeling markup
SPL body
Also 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 header
Also 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) 28
SPL Technology Presentation