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SPL V2b Subgroup, Feb 2005

Brief Overview of the Current Draft SPL V2b Specification: Clinical Product Information Module and Related Features. SPL V2b Subgroup, Feb 2005.

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SPL V2b Subgroup, Feb 2005

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  1. Brief Overview of the Current Draft SPL V2b Specification: Clinical Product Information Module and Related Features • SPL V2b Subgroup, Feb 2005

  2. Much of the following is significantly simplified and designed to create a good visual representation of principles rather than a technically correct representation of the details of the SPL standard. • SPL V2b Subgroup, Feb 2005

  3. What this is about … 754-7239-54 344---239-54 995-7239-62 344---239-54 344---239-54 35412358745 37636745 15145358745 3541231119 3541256666 • Contraindications • Ajqwh thqwht qkt qktrh trh qk kh kht kqwhklhj h wjth lkqwht kthhkt thj lkthqljkht qlthjsekthqw ekwhhkht jkth qkltjh qlkht qkh kl • Tju gktrh qwkth qkjg trg t k atrqhtqhtr ht wlh tglfhgkafhgkahl gkhg g ajgh aj gajkgf kajgf akjgh ajgjahgf ajgh ajg fkj gfjgfjkhgf akjdgh fajkgagf a gfasjg asjkgh asjgf ajkgf ajkg jh a • Asgf ajksdg fkjag adgf jakgf jkasdgf ajgf jagf ajgf ajk kajgf ajgf kajfhjg ajs asgf ajkgf jasgh jkghfkjasghf jkaghf agsd asjgh ashf asf aksgf jas asgf jkasgd fjkasgh ajsg jsdf jksg jasghf • hf ajsdg fjasg jksgsg j - gh dkasfjh gskah gkasdfh fkla - mhcg ag ,amcv ,ZXCV axkjcvax h ah akhjklahakh ka • Ijzhgfgfjagh jhgfjk gf jasghl asjgf jla as[dtuqs][tu[qiort t fg jkfdg kdfajagh ak;hg adfhg afkdgh kladfg ngf a,ga jhgas lahg asglas lajkhg asgh jkgfoiaghfialh gkqwjsgh kjsdfh gjklsdfhg jkdfhgkldfha lgjkfh gsdjkfh gjkdhasfgkjsdfgjkldfhg jdfgh ljkdfgh kldfjsgh ksdfljh gklsdjfhg kdfjsh ghdsfkljgh klsdfjgh ksdfjgh kldsfh gksdfjghsdkfjgh kdfgh kdsfhgkjdfh lsdkfjh gkdjsfg sdfh gjksldgsjkldfhgksdjlf g • Asf asjkdfjksfjasjdgfjgasdjklf galgfjkasdfgaskjdghasdhgfdasjgf jasdgf hjag jaj ajsd jgf jasdfgdjksag jgfaj CRL Computer Readable Labeling HRL Human Readable Labeling How to get from HRL to CRL ? • SPL V2b Subgroup, Feb 2005

  4. Before we answer this question … … let’s have a look at how computers (clinical decision support systems) use CRL. • SPL V2b Subgroup, Feb 2005

  5. Use of C-Labeling by Computers How Clinical Decision Support Systems use Computer-Readable Labeling • SPL V2b Subgroup, Feb 2005

  6. Use of C-Labeling by Computers 344---239-54 995-7239-62 344---239-54 344---239-54 754-7239-54 3541231119 35412358745 3541256666 37636745 15145358745 333-5656--1 344444--744 155---239-34 2228936745 155---239-66 7559931119 155---239-47 3541256666 CRL(e.g. Contraindications) E-Patient Record (e.g. Diagnoses) • SPL V2b Subgroup, Feb 2005

  7. Use of C-Labeling by Computers 754-7239-54 344---239-54 344---239-54 995-7239-62 344---239-54 35412358745 37636745 15145358745 3541231119 3541256666 333-5656--1 344444--744 155---239-34 2228936745 155---239-66 7559931119 155---239-47 3541256666 CRL(e.g. Contraindications) E-Patient Record (e.g. Diagnoses) • SPL V2b Subgroup, Feb 2005

  8. Use of C-Labeling by Computers 344---239-54 995-7239-62 344---239-54 754-7239-54 344---239-54 37636745 35412358745 15145358745 3541231119 3541256666 333-5656--1 344444--744 155---239-34 2228936745 155---239-66 7559931119 155---239-47 3541256666 CRL(e.g. Contraindications) Match E-Patient Record (e.g. Diagnoses) • SPL V2b Subgroup, Feb 2005

  9. Use of C-Labeling by Computers 344---239-54 754-7239-54 344---239-54 995-7239-62 344---239-54 3541256666 3541231119 37636745 35412358745 15145358745 333-5656--1 344444--744 155---239-34 2228936745 155---239-66 7559931119 155---239-47 3541256666 “Doctor, I found a contraindication. DO NOT PRESCRIBE THIS DRUG !” CRL (e.g. Contraindications) Match E-Patient Record (e.g. Diagnoses) • SPL V2b Subgroup, Feb 2005

  10. Use of C-Labeling by Computers 344---239-54 995-7239-62 344---239-54 754-7239-54 344---239-54 37636745 35412358745 15145358745 3541231119 3541256666 333-5656--1 344444--744 155---239-34 2228936745 155---239-66 7559931119 155---239-47 3541256666 CRL(e.g. Contraindications) Need totalk thesame language(code) E-Patient Record (e.g. Diagnoses) • SPL V2b Subgroup, Feb 2005

  11. Use of C-Labeling by Computers 754-7239-54 344---239-54 995-7239-62 344---239-54 344---239-54 35412358745 37636745 15145358745 3541231119 3541256666 CRL(e.g. Contraindications) Structuring and coding should be limited to what is necessary for a computer to generate meaningful alerts. It’s not l’art pour l’art • SPL V2b Subgroup, Feb 2005

  12. Now back to our original question: How do we get from human readable labeling to computer readable labeling? • SPL V2b Subgroup, Feb 2005

  13. Now back to our original question: How do we get from human readable labeling to computer readable labeling without losing human readability? • SPL V2b Subgroup, Feb 2005

  14. General Principles The Principles of Making Labeling Computer Readable • SPL V2b Subgroup, Feb 2005

  15. General Principles It’s not that difficult. XML technology helps us do the trick: The electronic document contains both the human readable text and the computer readable structured content with codes. • SPL V2b Subgroup, Feb 2005

  16. General Principles It’s not that difficult. XML technology helps us do the trick: The electronic document contains both the human readable text and the computer readable structured content with codes. Humans will see/print a neatly formatted text. Computers can find the codes and interpret them correctly. • SPL V2b Subgroup, Feb 2005

  17. General Principles • XML technology and encoding allows us to “translate” the meaning and the logical structure of labeling content into a corresponding structured set of codes. This is achieved by • flagging (“tagging”) individual concepts (such a dizziness, hypotension, 40 mg) • assigning an information type to these concepts (e.g.: Is hypertension the indication, a contraindication, or an ADR?) • defining the “formal” and “logical” relationship between elements (Is common the frequency of rash or nausea? Is dizziness the cause of something or the consequence?), • and encoding the medical concepts (e.g. dizziness becomes 1234567890) • SPL V2b Subgroup, Feb 2005

  18. General Principles • The SPL V2b Clinical Product Information Module provides the rules and tools for • tagging and assigning an information type to clinical concepts in a product label, • defining the formal and logical relationship between tagged elements, and • capturing the codes for the medical concepts. • It also allows us to define “wording elements” for the Highlights section, “connected to the corresponding full text paragraphs” and auto-displayed in the Highlights section. • SPL V2b Subgroup, Feb 2005

  19. General Principles • The SPL V2b Clinical Product Information Module provides the rules and tools for • tagging and assigning an information type to clinical concepts in a product label, • defining the formal and logical relationship between tagged elements, and • capturing the codes for the medical concepts. • It also allows us to define “wording elements” for the Highlights section, “connected to the corresponding full text paragraphs” and auto-displayed in the Highlights section. We are asked to review and helpimprove these rules and tools,as necessary. • SPL V2b Subgroup, Feb 2005

  20. Clinical Product Information Module • The crux of the module is the excerpt, which “abstracts” or “elevates” content from the narrative and provides metadata about that content: • Electronically enables “Highlights” from the US Proposed New Labeling Rule – Federal Register, December 22, 2000; CFR 65(247):81082-81131 • Provides a machine-readable “flag” to product use content found in the narrative • Code systems ensure consistency in excerpt content and interoperability with other clinical decision-support systems (CDSS) • Defining this information (coding it unambiguously) in a consistent and machine-readable way enables controlled information management in CDSS • SPL V2b Subgroup, Feb 2005

  21. Macro-Anatomy Macro-Anatomyof the Clinical Product Information Module • SPL V2b Subgroup, Feb 2005

  22. Macro-Anatomy 754-7239-54 111-31111 1211-76664 1211-76664 1211-76664 1211-76664 7555553756 7856983756 7856983756 2424243111 7452314577 1223344332 H Human Readable 1 INDICATIONS AND USAGE PRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis. 1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus. 1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]). *MDRSP, Multi-drug resistant Streptococcus pneumoniae includes …. To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Computer ReadableLabeling • SPL V2b Subgroup, Feb 2005

  23. Macro-Anatomy 754-7239-54 111-31111 1211-76664 1211-76664 1211-76664 1211-76664 2424243111 1223344332 7856983756 7856983756 7555553756 7452314577 H Human Readable 1 INDICATIONS AND USAGE PRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis. 1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus. 1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]). *MDRSP, Multi-drug resistant Streptococcus pneumoniae includes …. To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. This is not how itlooks in reality. It’s just avisualization of the principle. Computer ReadableLabeling • SPL V2b Subgroup, Feb 2005

  24. Macro-Anatomy 1211-76664 754-7239-54 1211-76664 111-31111 1211-76664 1211-76664 2424243111 1223344332 7856983756 7452314577 7856983756 7555553756 Corresponding wording for Highlights section: “Acute bacterial exacerbation of chronic bursitis …” Computer ReadableLabeling H Human Readable 1 INDICATIONS AND USAGE PRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis. 1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus. 1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]). *MDRSP, Multi-drug resistant Streptococcus pneumoniae includes …. To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. • SPL V2b Subgroup, Feb 2005 • SPL V2b Subgroup, Feb 2005

  25. CRL and Highlights wording are “parallel elements”. • CRL can cover more content than Highlights wording. • CRL can exist without Highlights wording. Macro-Anatomy 1211-76664 754-7239-54 1211-76664 111-31111 1211-76664 1211-76664 1223344332 2424243111 7856983756 7856983756 7555553756 7452314577 Corresponding wording for Highlights section: “Acute bacterial exacerbation of chronic bursitis …” Computer ReadableLabeling H Human Readable 1 INDICATIONS AND USAGE PRODUCT is indicated for the treatment of infections caused by susceptible strains of the microorganisms in the conditions listed below for patients 40 years old and above). 1.1 Acute bacterial exacerbation of chronic bursitis due to Haemophilus influenzae,Streptococcus pneumoniae, bursiticus or nasalis, or Moraxella catarrhalis. 1.2 Acute bacterial phlebitis due to Staphylococcus aureus or albus. 1.3 Community-acquired bronchitis (of mild to moderate severity) due to Haemophilus influenzae, or Streptococcus or Mycoplasma pneumoniae (including multi-drug resistant Streptococcus pneumoniae isolates [MDRSP*]). *MDRSP, Multi-drug resistant Streptococcus pneumoniae includes …. To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRODUCT and other antibacterial drugs, PRODUCT should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. • SPL V2b Subgroup, Feb 2005 • SPL V2b Subgroup, Feb 2005

  26. Macro-Anatomy CRL Highlights element “Excerpt” • SPL V2b Subgroup, Feb 2005

  27. Macro-Anatomy CRL Highlights element “Excerpt” Not every subsection needs to have an Excerpt. • SPL V2b Subgroup, Feb 2005

  28. Macro-Anatomy CRL Highlights element “Excerpt” Not every Excerpt needs to have Highlights wording. • SPL V2b Subgroup, Feb 2005

  29. Macro-Anatomy In SPL, excerpts can sit underneath each subsection. They are invisible ina regular browserview or printout … • SPL V2b Subgroup, Feb 2005

  30. Macro-Anatomy Highlights … except for Highlights wording, which is auto-displayed in the Highlights section • SPL V2b Subgroup, Feb 2005

  31. Let us now look at the rules and tools forassigning an information type to clinical concepts and maintaining the “logical relationship” between them. • SPL V2b Subgroup, Feb 2005

  32. Capturing Information Types and Relationships Assigning an Information Type to Individual Clinical Concepts and Maintaining their Relationship • SPL V2b Subgroup, Feb 2005

  33. Capturing Information Types and Relationships • For humans, we use three mechanisms to tell physicians what to do and/or how to interpret information. • Calling certain conditions “names”, such as indication, contraindication, non-indication, ADR, interaction. • Providing explicit advice, e.g. “do monitor patients with XYZ for …”, “… carefully weigh the benefits and risks in patients with …” • Implying actions (not being explicit). It is usually not necessary to tell a physician to carefully weigh the benefits and risks in the presence of serious risks. They know to do that anyway. • SPL V2b Subgroup, Feb 2005

  34. Capturing Information Types and Relationships • For humans, we use three mechanisms to tell physicians what to do and/or how to interpret information. • Calling certain conditions “names”, such as indication, contraindication, non-indication, ADR, interaction. • Providing explicit advice, e.g. “do monitor patients with XYZ for …”, “… carefully weigh the benefits and risks in patients with …” • Implying actions (non being explicit). It is usually not necessary to tell a physician to carefully weigh the benefits and risks in the presence of serious risks. They do that anyway. • Computer readable labeling has totell computers how to “interpret”labeling content so that they can act. Possible actions include: • Preventing a prescription unless overruled, or at least • Displaying information to physicians so that these can act. • SPL V2b Subgroup, Feb 2005

  35. Capturing Information Types and Relationships As an important means of telling computers how to interpret labeling content, the SPL spec defines “classes” of information. These classes (sort of) tell a computer how to interpret content and, possibly, act. Clinical information needs to be put in those classes to become computer interpretable and actable. • SPL V2b Subgroup, Feb 2005

  36. Capturing Information Types and Relationships STRANGENAMESXING As an important means of telling computers how to interpret labeling content, the SPL spec defines “classes” of information. These classes (sort of) tell a computer how to interpret content and, possibly, act. Clinical information needs to be put in those classes to become computer interpretable and actable. • SPL V2b Subgroup, Feb 2005

  37. Capturing Information Types and Relationships IndicationObservationCriterion ClinicalSituationCriterion TreatmentClass MonitoringObservationSteps Issue Reason for substance administration Limits indication to special population/situation(e.g. age group) – is a precondition Describes the intent of treatment, e.g. for ß-blocker“antihypertensive” or “antiarrhytmic” Tests to be performed, and their frequency Adverse reaction, interaction, … Here are some examples of classes: CLASS • SPL V2b Subgroup, Feb 2005

  38. Capturing Information Types and Relationships It is very important that SPL has all the classes necessary to capture important clinical information. • SPL V2b Subgroup, Feb 2005

  39. Let us now gofrom 35,000 ftdown to 10,000 ft. • SPL V2b Subgroup, Feb 2005

  40. SPL r2 Overview (10000 ft) Document, Section, Product Description and Listing Information Prescribing Information: Indication,Dosage & AdministrationContraindications,Interactions,Adverse Effects, Cautions,Monitoring • SPL V2b Subgroup, Feb 2005

  41. SPL r2 Document and Product Description • SPL V2b Subgroup, Feb 2005

  42. SPL r2 Document, Section, Highlight (Excerpt) • SPL V2b Subgroup, Feb 2005

  43. SPL r2 Document and Product Description • SPL V2b Subgroup, Feb 2005

  44. SPL r2 Product Description (Listing Information) • SPL V2b Subgroup, Feb 2005

  45. SPL r2 Document and Listing Information • SPL V2b Subgroup, Feb 2005

  46. SPL r2 Overview (10000 ft) Prescribing Information: Indication,Dosage & AdministrationContraindications,Interactions,Adverse Effects, Cautions,Monitoring • SPL V2b Subgroup, Feb 2005

  47. SPL r2 Clinical Product Information • SPL V2b Subgroup, Feb 2005

  48. SPL r2 Indication and Dosage • SPL V2b Subgroup, Feb 2005

  49. SPL r2 Clinical Product Information • SPL V2b Subgroup, Feb 2005

  50. SPL r2 Contraindication, Interaction, Caution • SPL V2b Subgroup, Feb 2005

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