who drug dictionary north american user group meeting
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WHO Drug Dictionary North American User Group Meeting. Chicago (Deerfield), IL October 1, 2009. ATC Coding Revisited. George B. Stoms Vital Systems, Inc. [email protected] (847) 458-2900 x222. Presentation Overview. WHO Drug Dictionary – quick review - PowerPoint PPT PresentationTRANSCRIPT
WHO Drug DictionaryNorth American
User Group MeetingChicago (Deerfield), IL
October 1, 2009
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 2
ATC Coding Revisited
George B. Stoms
Vital Systems, Inc.
[email protected] (847) 458-2900 x222
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 4
Drug Record Number
Example: Advil (DRecNum=1092)
Ibuprofen Doloflam
Advil Haltran
Advil Liqui-gels Ibubufen
Actiprofen Ibuspray
Zofen Motrin
Nuprin Boots fever and pain reliever
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 Slide 5
Drug Code: DRecNum + Seq1 + Seq2• Seq1: Salt or Ester (Herbal: Plant part)
Seq2: Trade Name or Synonym (generics)
DRecNum Seq1 Seq2 Name
000005 01 001 Ampicillin
000005 01 002 Ampicin
000005 01 003 Binotal
000005 02 001 Ampicillin Sodium
000005 02 002 Binotal
000005 02 003 Polycillin-n
000005 03 001 Ampicillin Trihydrate
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 6
Drug Code: DRecNum + Seq1 + Seq2 Seq1: Salt or Ester• Seq2: Trade Name or Synonym (generics)
DRecNum Seq1 Seq2 Name
000005 01 001 Ampicillin
000005 01 002 Ampicin
000005 01 003 Binotal
000005 02 001 Ampicillin Sodium
000005 02 002 Binotal
000005 02 003 Polycillin-n
000005 03 001 Ampicillin Trihydrate
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 7
Medicinal Product IDThe MP ID: version “C” of the WHO dd.It is unique to each entry in the dictionary.
MP ID DRecNum Seq1 Seq2 Name
000143 000005 01 001 Ampicillin
083950 000005 01 002 Ampicin
083951 000005 01 003 Binotal
000225 000005 02 001 Ampicillin Sodium
084022 000005 02 002 Binotal
084023 000005 02 003 Polycillin-n
000251 000005 03 001 Ampicillin Trihydrate
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 9
ATC: 5 Class LevelsATC Level ATC Code ATC Text
1 Anatomical Main Group
A Alimentary tract and metabolism
2 Therapeutic Subgroup
A10 Drugs used in diabetes
3 Pharmacological Subgroup
A10B Oral blood glucose lowering drugs
4 Chemical Subgroup A10B A Biguanides
5 Chemical Substance A10B A02 Metformin(DRecNo: 827)
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 10
*New Herbal ATC: 5 Class LevelsATC Level ATC Code ATC Text
1 Anatomical Main Group
A Alimentary tract and metabolism
2 Therapeutic Subgroup
A06 Herbal laxatives
3 Pharmacological Subgroup
A06A Laxatives
4 Chemical Subgroup A06A B Contact laxatives
5 Chemical Substance A06A B5001 Aloe ferox extract(DRecNo: 16518)
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 11
Level 1 - Anatomical Groups (14)A ALIMENTARY TRACT AND METABOLISM
B BLOOD AND BLOOD FORMING ORGANS
C CARDIOVASCULAR SYSTEM
D DERMATOLOGICALS
G GENITO URINARY SYSTEM AND SEX HORMONES
H SYSTEMIC HORMONAL PREPARATIONS, EXCL.
J ANTIINFECTIVES FOR SYSTEMIC USE
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
M MUSCULO-SKELETAL SYSTEM
N NERVOUS SYSTEM
P ANTIPARASITIC PRODUCTS,INSECTICIDES AND REPELLENTS
R RESPIRATORY SYSTEM
S SENSORY ORGANS
V VARIOUS
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 12
Level 2 – Therapeutic GroupsATC2 Selected Examples
A10 DRUGS USED IN DIABETES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
C02 ANTIHYPERTENSIVES
C07 BETA BLOCKING AGENTS
H03 THYROID THERAPY
L04 IMMUNOSUPPRESSIVE AGENTS
M03 MUSCLE RELAXANTS
N01 ANESTHETICS
S01 OPHTHALMOLOGICALS
S02 OTOLOGICALS
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 13
Level 3 - Pharmacological GroupsATC3 Selected Examples
A02A ANTACIDS
A06A LAXATIVES
A10A INSULINS AND ANALOGUES
N05A ANTIPSYCHOTICS
N06A ANTIDEPRESSANTS
* S01 = OPHTHALMOLOGICALS (eye) ** S02 = OTOLOGICALS (ear)
S01A ANTIINFECTIVES*
S01C ANTIINFLAMMATORY AGENTS & ANTIINFECTIVES IN COMB*
S02A ANTIINFECTIVES**
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 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
Do we see clearly what is really needed?
Melbourne's Digital Harbour Port 1010, Australian Customs Service (2006)
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 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 Slide 19
CDISC: CDASHCDASH (Clinical Data Acquisition Standards Harmonization) Section 5.5
CMTRTMedication Name
CMINDCIndication for taking this medication
CMAENOIdentifier for the Adverse Event that is the
indication CMMHNO
Identifier for the Medical History that is the indication
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 20
Difficulties using ATC for consolidation
CRFCM WHO Drug
(version) CMDECOD
DrugCode
CMCLAS
ATC #2?
ATC #1?
ATC #3?
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 21
Instead: WHOdrug + MedDRA
CRFCM
CRFMH
CRFAE
MedDRA(version)
WHO Drug(version)
CMMHNO
CMAENO
CMDECOD
DrugCode
CMCLAS
PT
SOC
LLT
MeaningfulGrouping
Medications taken for…
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 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 Slide 24
Listing 16.2.4.6: Concomitant Medications During Treatment Period
Subj Tx ----------------------- Medication Name -------------------- Start Stop For
ID cohort Age Sex Reported Preferred* date date AE
2103 5 mg 37 M XYLOCAIN LIDOCAINE 07 JUL 2004 07 JUL 2004 NO
ULTRACAIN ARTICAINE 07 JUL 2004 07 JUL 2004 NO
RIZATRIPTAN RIZATRIPTAN 13 JUL 2004 13 JUL 2004 YES
2104 5 mg 35 M CITALOPRAM 20MG CITALOPRAM 01 JAN 2004 ONGOING NO
BISOPROLOL 5MG O/D BISOPROLOL 01 JUN 2004 28 JUL 2004
TYLENOL EXTRA STR PARACETAMOL 06 JUL 2004 06 JUL 2004 YES
ACETAMINOPHEN PARACETAMOL 12 JUL 2004 12 JUL 2004 YES
PARACETAMOL 750 MG PARACETAMOL 12 JUL 2004 19 JUL 2004 YES
PARACETAMOL 1G PARACETAMOL 14 JUL 2004 14 JUL 2004 YES
2107 5 mg 46 M VALERON TILIDINE 01 MAR 2002 ONGOING NO
VALORON 150/12MG TILIDINE 01 MAR 2002 ONGOING
NEURONTIN GABAPENTIN 01 MAR 2002 ONGOING NO
METOCLOPRAMID METOCLOPRAMIDE 12 JUL 2004 ONGOING YES
NEURONTIN 600MG GABAPENTIN 01 MAR 2002 ONGOING
(continues…)
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 26
Tables – if grouping by ATC…Choose an ATC strategy
1. Select a “primary ATC” based on the indication for each individual report
2. Select a “primary ATC” once per drug within the study or program
3. Select a “primary ATC” once per drugwithin the company
4. “Let the dictionary do the walking…”
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 27
Table 14.1.4.4: Concomitant Medications During Treatment Period by Treatment Cohort
Safety Evaluable Population
5 mg 10 mg 20 mg All
Drug Class (ATC) (N = 8) (N = 8) (N = 8) (N = 24)
Preferred Name n (%) n (%) n (%) n (%)
SUBJECTS WHO TOOK CONCOMITANT MEDS 4 (50.0) 4 (50.0) 5 (62.5) 13 (54.2)
ANALGESICS 4 (50.0) 2 (25.0) 1 (12.5) 7 (29.2)
ANTIGRIPPINE 0 (0.0) 1 (12.5) 0 (0.0) 1 (4.2)
DOLORIN 0 (0.0) 0 (0.0) 1 (12.5) 1 (4.2)
GABAPENTIN 1 (12.5) 0 (0.0) 0 (0.0) 1 (4.2)
PARACETAMOL 2 (25.0) 1 (12.5) 1 (12.5) 4 (16.7)
RIZATRIPTAN 1 (12.5) 0 (0.0) 0 (0.0) 1 (4.2)
SUMATRIPTAN 0 (0.0) 1 (12.5) 0 (0.0) 1 (4.2)
TILIDINE 1 (12.5) 0 (0.0) 0 (0.0) 1 (4.2)
ANESTHETICS 1 (12.5) 0 (0.0) 0 (0.0) 1 (4.2)
ARTICAINE 1 (12.5) 0 (0.0) 0 (0.0) 1 (4.2)
LIDOCAINE 1 (12.5) 0 (0.0) 0 (0.0) 1 (4.2)
(continues…)
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 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 Slide 30
Analysis Techniques• Prohibited Meds
• Eligibility Criteria
• Efficacy Suppression
• Efficacy Synergism
• Drug Sparing
• Comparative Effectiveness
• Safety Signals / Pharmacovigilance
• “Co-medication Profiles”
AE profiles within ATC
• Secondary Indications
• Residual Subject Recruitment
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009 Slide 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 Slide 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 Slide 33
ATC Coding Revisited
George B. Stoms
Vital Systems, Inc.
[email protected] (847) 458-2900 x222
WHO Drug DictionaryNorth American
User Group MeetingChicago (Deerfield), IL
October 1, 2009