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WHO Drug Dictionary North American User Group Meeting

WHO Drug Dictionary North American User Group Meeting. Chicago (Deerfield), IL October 1, 2009. ATC Coding Revisited. George B. Stoms Vital Systems, Inc. George.Stoms@VTLsys.com (847) 458-2900 x222. Presentation Overview. WHO Drug Dictionary – quick review

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WHO Drug Dictionary North American User Group Meeting

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  1. WHO Drug DictionaryNorth AmericanUser Group Meeting Chicago (Deerfield), ILOctober 1, 2009

  2. ATC Coding Revisited George B. Stoms Vital Systems, Inc. George.Stoms@VTLsys.com (847) 458-2900 x222 WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  3. Presentation Overview • WHO Drug Dictionary – quick review • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Change Management WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  4. Drug Record Number DRecNum allows for grouping of all “synonyms” for the drug, including various companies, brands, generics, countries, preparations, etc. WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  5. Drug Code: DRecNum + Seq1 + Seq2 • Seq1: Salt or Ester (Herbal: Plant part) • Seq2: Trade Name or Synonym (generics) WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  6. Drug Code: DRecNum + Seq1 + Seq2 • Seq1: Salt or Ester • Seq2: Trade Name or Synonym (generics) WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  7. Medicinal Product ID The MP ID: version “C” of the WHO dd.It is unique to each entry in the dictionary. WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  8. ATC classification • Anatomical • The organ or system on which a drug acts • Therapeutic (& Pharmacological) • Indication for typical use(s) • Pharmacological Form • Chemical • Compound structure and properties WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  9. ATC: 5 Class Levels WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  10. *New Herbal ATC: 5 Class Levels WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  11. Level 1 - Anatomical Groups (14) WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  12. Level 2 – Therapeutic Groups WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  13. Level 3 - Pharmacological Groups * S01 = OPHTHALMOLOGICALS (eye) ** S02 = OTOLOGICALS (ear) WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  14. ATC codes: comments • Each product has at least one ATC code. • The same product may have more than one ATC code, because it could be used for different indications, formulations, etc. • The drug code and MP ID are mapped to all ATCs in the dictionary hierarchy. • ATC classifications can change over time with dictionary updates. WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  15. Presentation Overview • WHO Drug Dictionary – quick review • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Change Management WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  16. Do we see clearly what is really needed? Melbourne's Digital Harbour Port 1010, Australian Customs Service (2006)

  17. Clinical Trial Databases • What should we capture in the CTDB? • Options: • Verbatim Text + CRF fields • Drug Record Number • Drug Code (DRecNum + Seq1 + Seq2) • Medicinal Product ID • Generic (Preferred) Name / Decode • ATC code ??? WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  18. CDISC: SDTM - SDTM 3.1 Implementation Guide, Section 4.1.3.5 …fill CMDECOD with the drug’s generic nameand fill CMCLAS with the drug class only if the dictionary used codes drugs to a single class. When using WHODRUG, for example, CMCLAS would not be filled since a drug may have multiple classes. … No other intermediate levels or relationships should be stored in the dataset. By knowing the dictionary and version used, the reviewer will be able to obtain intermediate levels ... a drug’s ATC codes (as in WHO Drug). WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  19. CDISC: CDASH CDASH (Clinical Data Acquisition Standards Harmonization)Section 5.5 • CMTRT Medication Name • CMINDC Indication for taking this medication • CMAENO Identifier for the Adverse Event that is the indication • CMMHNOIdentifier for the Medical History that is the indication WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  20. Difficulties using ATC for consolidation CRFCM WHO Drug(version) DrugCode CMDECOD CMCLAS ATC #1? ATC #2? ATC #3? WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  21. Instead: WHOdrug + MedDRA CRFCM WHO Drug(version) DrugCode CMDECOD CMCLAS CRFMH CMMHNO MeaningfulGrouping MedDRA(version) SOC CRFAE PT CMAENO LLT Medications taken for… WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  22. Presentation Overview • WHO Drug Dictionary – quick review • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Change Management WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  23. Data Presentations: Listings • Verbatim reported name • “Preferred” name • Seq1 = 01 • Seq2 = 001 • ATC Level(s) ? • CRF fields (dose, route, dates, etc) WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  24. WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  25. Tables – if grouping by ATC… Choose ATC level to group by: • ATC1: Anatomical • ATC2: Therapeutic • Other WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  26. Tables – if grouping by ATC… Choose an ATC strategy • Select a “primary ATC” based on the indication for each individual report • Select a “primary ATC” once per drug within the study or program • Select a “primary ATC” once per drugwithin the company • “Let the dictionary do the walking…” WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  27. WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  28. Challenges when using ATC for grouping • What about “double counting” ATCs?Since a drug may have more than one ATC, it will could show up in multiple sections of a table. The totals won’t sum correctly. Isn’t this a problem? • Only if it is not understood and explained (footnote) • The table’s purpose is to show how many subjects dosed with a med of a certain “type”. • Even if the med was taken for a different reason (indication/ATC) is still belongs to each “type”. • Only the totals across “types” become irrelevant WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  29. Presentation Overview • WHO Drug Dictionary – quick review • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Change Management WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  30. Analysis Techniques • Safety Signals / Pharmacovigilance • “Co-medication Profiles” AE profiles within ATC • Secondary Indications • Residual Subject Recruitment • Prohibited Meds • Eligibility Criteria • Efficacy Suppression • Efficacy Synergism • Drug Sparing • Comparative Effectiveness WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  31. Presentation Overview • WHO Drug Dictionary – quick review • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Change Management WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  32. Change Management • Highlighting the problem / “Feel the Pain” • Budget, Staffing, Timelines • Identify stakeholders • CDM, Statistics, Safety, Regulatory, Licensing • Early preparation / meetings • Anticipate resistance / Bring solutions • Pilot (concurrent study) • Plan for implementation • Feedback Loop  ROI WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  33. ATC Coding Revisited George B. Stoms Vital Systems, Inc. George.Stoms@VTLsys.com (847) 458-2900 x222 WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009

  34. WHO Drug DictionaryNorth AmericanUser Group Meeting Chicago (Deerfield), ILOctober 1, 2009

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