New technical requirements for Labeling by mikesanye


									            The Technology of
            Structured Product Labeling

                          Presented by Robert H. Wallace

                          06 June 2004

SPL Technology Presentation
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

   SPL Technology Presentation
Creating an SPL Package Insert

             To create an SPL-compliant package insert, you
             need the following:
                 Code system IDs and vocabularies
                    Any additional codes
                 Your company’s object identifier (OID)
                 SPL schema
                 Implementation guide (to put it all together)
   SPL Technology Presentation
Code Systems and OIDs

               Vocabularies for SPL sections, etc. are controlled by code
                    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
   SPL Technology Presentation
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)

   SPL Technology Presentation
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

   SPL Technology Presentation
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
   SPL Technology Presentation
Document Attribute Example

                                 <time value="20030106"/>
                                            <id extension="PH00017" root="2.16.840.1.113883.3.933"/>
                                                      <name>Midwestern Pharmaceuticals</name>
                                                      <addr>Metropolis, IN 46285, USA</addr>
                                                                          Identifying the
                                                                          package insert
                                                                         source company
   SPL Technology Presentation
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)

   SPL Technology Presentation
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
   SPL Technology Presentation
Structured Content Example

                         <code code="122111-03-9" codeSystem="2.16.840.1.113883.6.61"
                codeSystemName=“Chemical Abstract Service"/>
                                 <name>gemcitabine HCl</name>
                                                                  Identifying the
                                                                  package insert
   SPL Technology Presentation
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
    SPL Technology Presentation
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
                           Subscript and superscript
                           Line break – Line control (soft break), not a paragraph
                           renderMultiMedia – Place for graphic to appear in
                           List – Ordered (numbered) or unordered (bulleted) lists
                           Table – Modified XHTML table model (similar to Web
                           Caption – Can label any other block structure           13
   SPL Technology Presentation
Narrative Block Example

                                   <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"/>
                                     <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). . . .
                                                                      Identifying the
                                                                    Description Section
   SPL Technology Presentation

           Rendering of an SPL-compliant file usually presents
           only the narrative block
               Narrative block contains all the text we think of as
               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

   SPL Technology Presentation
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

   SPL Technology Presentation
Rendering Examples

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

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Add and Delete

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Font Effects

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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?)

   SPL Technology Presentation
SPL - terminology

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

                        Health Level 7: An ANSI-accredited standards developing organization

                        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

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