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2 ND U.S. WHO Drug Dictionary User Group Meeting

2 ND U.S. WHO Drug Dictionary User Group Meeting. Boston, MA April 20, 2006. ATC Codes: Strategies for Adding Value Instead of Confusion. George B. Stoms Vital Systems, Inc. George.Stoms@VTLsys.com (847) 458-2900 x222. Presentation Overview. ATC classifications – quick primer

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2 ND U.S. WHO Drug Dictionary User Group Meeting

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  1. 2ND U.S. WHO Drug DictionaryUser Group Meeting Boston, MAApril 20, 2006

  2. ATC Codes: Strategies for Adding Value Instead of Confusion George B. Stoms Vital Systems, Inc. George.Stoms@VTLsys.com (847) 458-2900 x222 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  3. Presentation Overview • ATC classifications – quick primer • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Strategies for using the WHO Drug Dictionary to enhance value 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  4. ATC System - History • 1969: Olso symposium “The Consumption of Drugs” • Drug Utilization Research Group (DURG) established. • European Pharmaceutical Market Research Association (EPhMRA) classification system modified = ATC classification • 1975: Nordic Council on Medicines (NLN) published ATC/DDD • 1981: WHO Regional Office for Europe recommends ATC for drug utilization studies. • 1982: WHO Collaborating Centre for Drug Statistics Methodology established • 1996: Oversight moved to WHO Headquarters in Geneva for international integration 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  5. ATC System - Currently • Published annually by the WHO Collaborating Centre for Drug Statistics Methodologyhttp://www.whocc.no/atcddd • Becoming more commonly used in Canada, currently managed by Health Canadahttp://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_drugs_dpd_e.html 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  6. 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 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  7. ATC: 5 Class Levels 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  8. *New Herbal ATC: 5 Class Levels 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  9. Level 1 - Anatomical Groups (14) 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  10. Level 2 – Therapeutic Groups 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  11. Level 3 - Pharmacological Groups * S01 = OPHTHALMOLOGICALS (eye) ** S02 = OTOLOGICALS (ear) 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  12. Presentation Overview • ATC classifications – quick primer • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Strategies for using the WHO Drug Dictionary to enhance value 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  13. Clinical Trial Databases • What should we capture in the CTDB? • Options: • Drug Record Number • Drug Code (DRecNum + Seq1 + Seq2) • Medicinal Product ID • ATC code • Verbatim Text 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  14. Drug Record Number DRecNum allows for grouping of all “synonyms” for the drug, including various companies, brands, generics, countries, preparations, etc. 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  15. Drug Code: DRecNum + Seq1 + Seq2 • Seq1: Salt or Ester (Herbal: Plant part) • Seq2: Trade Name or Synonym (generics) 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  16. Drug Code: DRecNum + Seq1 + Seq2 • Seq1: Salt or Ester • Seq2: Trade Name or Synonym (generics) 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  17. Medicinal Product ID The MP ID is new to version “C” of the WHO dd.It is unique to each entry in the dictionary. 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  18. 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. • The drug code and MP ID are mapped to all ATCs in the dictionary hierarchy. • ATC classifications can change over time with dictionary updates. 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  19. Verbatim Text • From source (CRF, progress notes, DCF) • Drug name • as reported by investigator or subject • as clarified by data management (strength, etc.) • Start/Stop dates and times • Dosage, Route • Indication • Taken for an Adverse Event (AE / SAE / ADR) • Taken as a concomitant medication or supplement • Previously ongoing therapy 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  20. Caution: Don’t lose sight of the purpose!

  21. So, what should we capture in the CTDB? • See discussion in “Guide” • Determine needs/goals of: • Statisticians / Programmers • Medical Writers (for CSR) • Drug Safety Group / Surveillance Team • DSMB • Future Licensing Partners (ISS, ISE, etc.) • Weigh benefits versus effort at data mgt level • Plan for versioning through regulatory life cycle • Capture the dictionary version in the CTDB! 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  22. Presentation Overview • ATC classifications – quick primer • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Strategies for using the WHO Drug Dictionary to enhance value 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  23. Data Presentations: Listings • Verbatim reported name • “Preferred” name • Seq1 = 01 • Seq2 = 001 • ATC Level (possibly) 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  24. 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  25. Data Presentations: Tables Choose ATC level to group by: • ATC1: Anatomical • ATC2: Therapeutic • Other 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  26. 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  27. 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 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  28. Presentation Overview • ATC classifications – quick primer • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Strategies for using the WHO Drug Dictionary to enhance value 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  29. Analysis Techniques • “Bottom Up” • Prohibited Med; Over-represented in ATC • “Top Down” • eg: ATC group; multi-ingredients; responder analysis • “Co-medication Profiles” • AE profiles within ATC levels, or • ATC profiles within AE groupings • “Guide” discussion and example • Precautions • Demographics (age/sex), Disease/Treatment, Population 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  30. Analysis: ATC Co-Med Profile 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  31. Analysis: AE vs ATC Profile A02AG = ANTACIDS WITH ANTISPASMODICS 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  32. Presentation Overview • ATC classifications – quick primer • What should we capture in a Clinical Trial Database? • Data Reduction / Presentation Techniques • Analysis Techniques • Strategies for using the WHO Drug Dictionary to enhance value 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  33. WHOdd: Value Enhancement Strategies • Co-medication Investigations • Safety Profiles (risks / protections) • Efficacy (synergism / suppression) • Economics (drug sparing) • DSMB / Surveillance / Vigilance • Development Partnerships / Licenses • Secondary Indications • Residual Subject Recruitment 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  34. ATC Codes: Strategies for Adding Value Instead of Confusion George B. Stoms Vital Systems, Inc. George.Stoms@VTLsys.com (847) 458-2900 x222 2nd U.S. WHO Drug Dictionary User Group Meeting - Boston, MA - Apr 20, 2006

  35. 2ND U.S. WHO Drug DictionaryUser Group Meeting Boston, MAApril 20, 2006

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