Transcript ATC Coding Revisited

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
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
Slide 2
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 3
Drug Record Number
DRecNum allows for grouping of all “synonyms”
for the drug, including various companies,
brands, generics, countries, preparations, etc.
Example: Advil (DRecNum=1092)
Ibuprofen
Doloflam
Advil
Haltran
Advil Liqui-gels
Ibubufen
Actiprofen
Ibuspray
Zofen
Motrin
Nuprin
Boots fever and pain reliever
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
Slide 4
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 5
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 6
Medicinal Product ID
The 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 7
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 8
ATC: 5 Class Levels
ATC 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 9
*New Herbal ATC: 5 Class Levels
ATC 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 10
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 11
Level 2 – Therapeutic Groups
ATC2
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 12
Level 3 - Pharmacological Groups
ATC3
Selected Examples
A02A
ANTACIDS
A06A
LAXATIVES
A10A
INSULINS AND ANALOGUES
N05A ANTIPSYCHOTICS
N06A ANTIDEPRESSANTS
S01A
ANTIINFECTIVES*
S01C ANTIINFLAMMATORY AGENTS & ANTIINFECTIVES IN COMB*
S02A
ANTIINFECTIVES**
* S01 = OPHTHALMOLOGICALS (eye)
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
** S02 = OTOLOGICALS (ear)
Slide 13
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 14
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 15
Do we see clearly what is really needed?
Melbourne's Digital Harbour Port 1010, Australian Customs Service (2006)
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 17
CDISC: SDTM
- SDTM 3.1 Implementation Guide, Section 4.1.3.5
…fill CMDECOD with the drug’s generic name
and 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 18
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
 CMMHNO
Identifier for the Medical History that is the indication
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
Slide 19
Difficulties using ATC for consolidation
CRF
CM
DrugCode
WHO Drug
(version)
CMDECOD
CMCLAS
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
Slide 20
Instead: WHOdrug + MedDRA
DrugCode
CRF
CM
WHO Drug
(version)
CMDECOD
CMCLAS
CMMHNO
CRF
MH
MedDRA
(version)
CMAENO
CRF
AE
SOC
PT
Meaningful
Grouping
LLT
Medications
taken for…
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
Slide 21
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 22
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 23
Listing 16.2.4.6: Concomitant Medications During Treatment Period
Subj
Tx
ID
cohort
Age
Sex
2103
5 mg
37
M
2104
2107
5 mg
5 mg
----------------------- Medication Name --------------------
35
46
M
M
Start
Stop
For
date
date
AE
Reported
Preferred*
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
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
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 24
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 25
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 drug
within the company
4. “Let the dictionary do the walking…”
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
Slide 26
Table 14.1.4.4: Concomitant Medications During Treatment Period by Treatment Cohort
Safety Evaluable Population
Drug Class (ATC)
5 mg
10 mg
20 mg
All
(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 27
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 28
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 29
Analysis Techniques
• Prohibited Meds
• Eligibility Criteria
• Efficacy Suppression
• Safety Signals /
Pharmacovigilance
• “Co-medication Profiles”
AE profiles within ATC
• Efficacy Synergism
• Drug Sparing
• Comparative
Effectiveness
• Secondary Indications
• Residual Subject
Recruitment
WHO Drug Dictionary User Group Meeting - Chicago/Deerfield, IL - Oct 1, 2009
Slide 30
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 31
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 32
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 33
WHO Drug Dictionary
North American
User Group Meeting
Chicago (Deerfield), IL
October 1, 2009