MedDRA Coding Basics

MedDRA Coding Basics
MedDRA® trademark is owned by IFPMA on behalf of ICH
MedDRA was developed under the auspices of the
International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The activities
of the MedDRA Maintenance and Support Services
Organization (MSSO) are overseen by an ICH MedDRA
Management Board
Board, which is composed of the six ICH
parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the
Medicines and Healthcare products Regulatory Agency
(MHRA) of the UK, Health Canada, and the WHO (as
Observer).
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3
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Course Objectives/Overview
• Learn the reasons we “code” data
MedDRA s
• Gain knowledge of MedDRA’s
structure, scope, and characteristics
• Learn about the MedDRA Term
Selection: Points to Consider
document
• Learn some basic coding approaches,
including some coding “pearls”
pearls
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Wh Do
Why
D W
We C
Code?
d ?
What Is “Coding”?
Code
1 : a systematic statement of a body of law; especially
one given statutory force
2 : a system of principles or rules <moral code>
3 a : a system of signals or symbols for communication
b : a system of symbols (as letters or numbers) used
t representt assigned
to
i
d and
d often
ft secrett meanings
i
4 : genetic code
5 : a set of instructions for a computer
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Why Do We Code?
• Retrieve
• Present
• Analyze
• Communicate
7
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Role of a Terminology
• Provides a TOOL to represent data/
concepts using “place
place-holder
holder” terms
• Assists in retrieval, analysis, and
comprehension
h
i off data
d t
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What Does MedDRA Offer?
• Size and specificity (“granularity”)
• Hierarchy/grouping terms
• “Support” SOCs widen data
collection/analysis options
• Up-to-date and medically rigorous
• User-responsive
• STANDARDIZATION
9
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M dDRA O
MedDRA
Overview
i
MedDRA Definition
MedDRA is a clinically-validated
international medical terminology used by
regulatory authorities and the regulated
biopharmaceutical industry. The
terminology is used through the entire
regulatory process, from pre-marketing to
post-marketing,
post
marketing, and for data entry,
retrieval, evaluation, and presentation.
11
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Scope of MedDRA
Not a drug
dictionary
Patient demographic
terms
Clinical trial study
design terms
OUT
IN
Frequency
qualifiers
Medical conditions
Indications
Investigations (tests, results)
Medical and surgical procedures
Medical,, social,, familyy historyy
Medication errors
Product quality issues
Device-related issues
Pharmacogenetic terms
Toxicologic issues
Standardized queries
Numerical values for
results
Severity descriptors
Not an equipment, device,
diagnostic product dictionary
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MedDRA Structure
System Organ Class (SOC) (26)
High Level Group Term (HLGT) (334)
High Level Term (HLT) (1,717)
P f
Preferred
dT
Term (PT) (20,057)
(20 057)
Lowest Level Term (LLT) (71,326)
(71 326)
MedDRA Version 16.0
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MedDRA Term Level Definitions
• SOC - Highest level of the terminology, and
representing an anatomical or physiological system,
etiology,
ti l
or purpose
• HLGT - Subordinate to SOC, superordinate grouping
for one or more HLTs
• HLT - Subordinate to HLGT, superordinate grouping
for one or more PTs
• PT - Represents a single medical concept
• LLT - Lowest level of the terminology, related to a
single PT as a synonym, lexical variant, or quasis non m (Note:
synonym
(Note All PTs have
ha e an identical LLT)
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System Organ Classes
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders and administration site
conditions
Hepatobiliary disorders
I
Immune
system
t
di
disorders
d
Infections and infestations
Injury, poisoning and procedural
complications
p
Investigations
Metabolism and nutrition disorders
•
•
•
•
•
•
•
•
•
•
•
•
Musculoskeletal and connective tissue
disorders
Neoplasms benign, malignant and unspecified
((incl cysts
y
and polyps)
p yp )
Nervous system disorders
Pregnancy, puerperium and perinatal
conditions
P hi t i disorders
Psychiatric
di d
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders
15
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Examples of LLTs
SOC = Cardiac
C di di
disorders
d
HLGT = Cardiac arrhythmias
HLT = Rate and rhythm disorders NEC
PT = Arrhythmia
LLT
Arrhythmia
NOS
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LLT
A h th i
Arrhythmia
LLT
Dysrhythmias
LLT (N
(Non-current))
Other specified cardiac
dysrhythmias
16
Non-Current Terms
•N
Non-currentt tterms are fl
flagged
d att th
the
LLT level within MedDRA
• Not recommended for continued use
• Retained within the terminology to
preserve
p
ese e historical
sto ca data for
o retrieval
et e a a
and
d
analysis
• Terms that are vague, ambiguous, outd t d truncated,
dated,
t
t d or misspelled
i
ll d
• Terms derived from other terminologies
that do not fit MedDRA rules
17
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MedDRA Codes
• Each MedDRA term assigned an 8
8-digit
digit
numeric code
• The code is non-expressive
• Codes can fulfill a data field in various
electronic submission types (e
(e.g.,
g E2B)
• Initially assigned alphabetically by term
starting with 10000001
– New terms are assigned sequentially
• Supplemental terms are assigned codes
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A Multi-Axial Terminology
•M
Multi-axial
lti i l = the
th representation
t ti off a
medical concept in multiple SOCs
– Allows
All
grouping
i by
b different
diff
t classifications
l ifi ti
– Allows retrieval and presentation via different
data sets
• Purpose of Primary SOC
– Determines which SOC will represent a PT
during cumulative data outputs
– Is used to support consistent data
presentation for reporting to regulators
19
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A Multi-Axial Terminology (cont)
SOC = Respiratory, thoracic and
mediastinal disorders
HLGT = Respiratory tract
infections
HLT = Viral upper respiratory
tract infections
SOC = Infections and
infestations
HLGT = Viral infectious
disorders
HLT = Influenza viral
infections
PT = Influenza
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A Multi-Axial Terminology (cont)
PTs in the following SOCs only appear in
that p
particular SOC and not in others,,
i.e., they are not multi-axial
• Investigations
• Surgical and medical procedures
• Social circumstances
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Rules for Primary SOC Allocation
• PTs for diseases
diseases, signs and symptoms are assigned to
prime manifestation site SOC
• Congenital and hereditary anomalies terms have SOC
C
Congenital,
l familial
f
l l and
d genetic disorders
d d
as Primary SOC
• Neoplasms terms have SOC Neoplasms benign,
malignant
g
and unspecified
p
(incl
(
cysts
y and p
polyps)
yp ) as
Primary SOC
– Exception: Cysts and polyps have prime manifestation site SOC
as Primary SOC
• Infections and infestations terms have SOC Infections
and infestations as Primary SOC
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Primary SOC Priority
If a PT links to more than one of the exceptions,
the following priority will be used to determine
primary SOC:
1st: Congenital, familial and genetic disorders
2nd: Neoplasms benign, malignant and
unspecified (incl cysts and polyps)
3rd: Infections and infestations
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MedDRA Term Selection:
Points to Consider Document
Why Do We Need Coding
Conventions?
• Differences in medical aptitude of coders
• Consistency concerns (many more
“choices” to manuallyy code terms in
MedDRA compared to older
g )
terminologies)
• Even with an autoencoder, may still need
manual coding
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MedDRA Term Selection:
Points to Consider (MTS:PTC)
• An ICH-endorsed guide for MedDRA users
• Provides term selection advice for industry
and regulatory purposes
• Objective is to promote accurate and
consistent term selection to facilitate a
common understanding
d t di off shared
h d data
d t
• Recommended to be used as the basis for
i di id l organizations’
individual
i ti
’ coding
di
conventions
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MedDRA Term Selection: PTC (cont)
• Developed by a working group of the ICH Steering
Committee
– Regulators and industry representatives
– EU, Japan, USA
– Canadian observer, MSSO, JMO
• U
Updated
d t d twice
t i yearly
l with
ith each
h MedDRA
M dDRA release
l
• Available on MSSO, JMO, and ICH Web sites
– English and Japanese
– Variety of file formats for ease of viewing and editing
– Summary of Changes document
27
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General Term Selection Principles
•
•
•
•
•
•
•
•
•
•
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Quality of Source Data
Quality Assurance
Do Not Alter MedDRA
Always Select a Lowest Level Term
Select Only Current Lowest Level Terms
When to Request a Term
Use of Medical Judgment in Term Selection
Selecting More than One Term
Check the Hierarchy
Select Terms for All Reported Information, Do Not
Add Information
28
Quality
Q
lit off Source
S
D t
Data
Quality Assurance
• Quality of original information impacts quality of
output
• Obtain clarification of data
• Can be optimized by careful design of data
collection
ll ti forms
f
and
d proper training
t i i off staff
t ff
• Organizations’ coding guidelines should be
consistent with MTS:PTC
• Review of term selection by qualified individuals
g of automated coding
g results
• Human oversight
29
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Do Not Alter MedDRA
• MedDRA is a standardized terminology
with a pre-defined
pre defined term hierarchy
• Users must not make ad hoc structural
alterations, including changing the
primary SOC allocation
• If terms are incorrectly placed, submit a
change request to the MSSO
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Always Select a Lowest Level Term
Select Only Current LLTs
• Lowest Level Term that most accurately
reflects
fl t th
the reported
t d verbatim
b ti information
i f
ti
should be selected
• Degree of specificity may be challenging
– Example: “Abscess on face” Æ select “Facial
abscess,” not simply “Abscess”
• Select current LLTs only
– Non-current terms for legacy conversion/historical
purposes
31
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When tto Request
Wh
R
t a Term
T
Use of Medical Judgment
• Avoid company-specific “work-arounds” for
MedDRA deficiencies
deficiencies. If concept not
adequately represented in MedDRA, submit
Change
g Request
q
to MSSO.
• If no exact match in MedDRA, use medical
judgment to match to an existing term that
adequately
d
t l represents
t th
the conceptt
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Selecting
S
l ti M
More th
than O
One Term
T
Check the Hierarchy
• Can select more than one LLT to represent
reported information
information. Document procedures
procedures.
– Selecting one term may lead to loss of specificity
– Selecting more than one term may lead to
redundant counts
• Check the hierarchy above a selected LLT
(PT HLT
(PT,
HLT, HLGT,
HLGT SOC) to ensure
ens e placement
accurately reflects meaning of reported term
33
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S l t Terms
Select
T
for
f All Reported
R
t d
Information
• Select terms for every AR/AE reported,
regardless of causal association
• Select terms for device-related events,
product quality issues,
issues medication errors,
errors
medical and social history, investigations
and indications as appropriate
• If diagnosis reported with characteristic
signs and symptoms, preferred option is to
select term for diagnosis only
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Do Not Add Information
• Do not make diagnosis if only
signs/symptoms reported
Reported
LLT Selected
Comment
Abdominal pain
Abdominal pain,
increased serum
amylase, and increased
serum lipase
Serum amylase
i
increased
d
It is inappropriate
to assign
g an LLT for
diagnosis of
“pancreatitis”
Lipase increased
35
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Pitfalls and Solutions
• In selecting an LLT for a result of an
investigation, parent PT of the selected LLT should
contain a qualifier/adjective
– E.g., “present/absent”, “increased/decreased”, etc.
• If parent PT of selected LLT does not contain a
qualifier/adjective,
lifi / dj ti
you may have
h
inadvertently
i d t tl
selected an LLT for the test name, not a result
– E.g.,
E g “Blood
Blood found in urine
urine”, select LLT Blood in
urine (PT Blood urine present). Do not select LLT
Blood urine (PT Blood urine has no qualifier/
adjective
dj ti and
d thus
th represents
t the
th test
t t name only)
l )
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Pitf ll and
Pitfalls
d Solutions
S l ti
((cont)
t)
• Inappropriate terms may be selected by
autocoder
• Review all autocoding carefully
– “Allergic to CAT scan” autocoded as
LLT Allergic to cats
– “Myocardial infarction in the fall of 2000”
autocoded as LLT Myocardial infarction and
LLT Fall
F ll
37
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FDA-Defined Coding Errors
• Missed Concepts
– All medical concepts described after the product is
taken should be coded
– Example: “The patient took drug X and developed
alopecia, increased LFTs and pancreatitis”.
p
and increased
Manufacturer onlyy codes alopecia
LFTs (missed concept of pancreatitis)
– Example: “The patient took drug X and developed
interstitial nephritis which later deteriorated into
renal failure”. Manufacturer only codes interstitial
nephritis (missed renal failure concept)
Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance
and Epidemiology, CDER
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FDA-Defined Coding Errors (cont)
• “Soft Coding”
– Selecting a term which is both less specific and less
severe than
th another
th M
MedDRA
dDRA term
t
is
i “soft
“ ft coding”
di ”
– Example: “Liver failure” coded as hepatotoxicity or
increased LFTs
– Example: “Aplastic anemia” coded as unspecified
anemia
– Example: “Rash subsequently diagnosed as Stevens
Johnson syndrome” coded as rash
Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance
and Epidemiology, CDER
39
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Term Selection Points
• Diagnoses
g
and Provisional Diagnoses
g
with or without Signs
g and
Symptoms
• Death and Other Patient Outcomes
• Suicide and Self-Harm
• Conflicting/Ambiguous/Vague Information
• Combination Terms
• Age vs. Event Specificity
• Body Site vs.
vs Event Specificity
• Location Specific vs. Microorganism Specific Information
• Modification of Pre-existing Conditions
• Exposures During Pregnancy and Breast Feeding
• Congenital Terms
• Neoplasms
• Medical and Surgical Procedures
• Investigations
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T
Term
Selection
S l ti Points
P i t (cont)
(
t)
• Medication/Administration Errors, Accidental Exposures and
Occupational Exposures
• Misuse, Abuse and Addiction
• Transmission of Infectious Agent via Product
• Overdose,
Overdose Toxicity and Poisoning
• Device-related Terms
• Drug Interactions
• No
N Adverse
Ad
Effect
Eff t and
d “Normal”
“N
l” T
Terms
• Unexpected Therapeutic Effect
• Modification of Effect
• Sociall Circumstances
• Medical and Social History
• Indication for Product Use
• Off Label Use
• Product Quality Issues
41
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Diagnoses and Provisional Diagnoses
SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS
Single diagnosis without signs
and
d symptoms
t
PROVISIONAL DIAGNOSIS
Single provisional diagnosis
without
ith t signs
i
and
d symptoms
t
•Diagnosis (only possible option) •Provisional diagnosis (only
possible option)
Example: “Myocardial
infarction” Æ select
“Myocardial infarction”
Example: “Possible myocardial
infarction” Æ select
“Myocardial infarction” (select
term as if definitive diagnosis)
Similar principles apply for multiple diagnoses
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Diagnoses and Provisional Diagnoses (cont)
SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS
PROVISIONAL DIAGNOSIS
Single diagnosis with signs/
symptoms
Single provisional diagnosis with
signs/symptoms
•Preferred: Diagnosis only
•Preferred: Provisional
diagnosis and signs/symptoms
Example: “Anaphylactic
Example: “Possible myocardial
reaction with rash, dyspnea,
hypotension, and laryngospasm”
hypotension
Æ select “Anaphylactic
reaction”
infarction with chest pain,
dyspnea, diaphoresis” Æ select
dyspnea
“Myocardial infarction” “Chest
pain”, “Dyspnea”, and
“Diaphoresis”
Similar principles apply for multiple diagnoses
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Diagnoses and Provisional Diagnoses (cont)
SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS
PROVISIONAL DIAGNOSIS
Single diagnosis with signs/
symptoms
ymp m
Single provisional diagnosis with
signs/symptoms
g / ymp m
•Alternate: Diagnosis and
signs/symptoms
•Alternate: Signs/symptoms
only (as provisional diagnosis
may change
Example: “Anaphylactic reaction Example: “Possible myocardial
with rash,, dyspnea,
y p , hypotension,
yp
, infarction with chest p
pain,,
and laryngospasm” Æ select
dyspnea, diaphoresis” Æ select
“Anaphylactic reaction”, “Rash”, “Chest pain”, “Dyspnea”, and
“Dyspnea”, Hypotension”, and
“Diaphoresis”
“Laryngospasm”
Similar principles apply for multiple diagnoses
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Conflicting/Ambiguous Information
• First, try to obtain more specific information
Reported
Hyperkalemia with a
serum potassium of 1.6
mEq/L
GU pain
LLT Selected
Serum potassium
abnormal
Pain
Comment
LLT Serum
S
potassium
t i
abnormal covers both of
the reported concepts
(note: serum potassium of
1 6 mEq/L
1.6
E /L is
i a low
l
result,
lt
not high)
“GU” could be either
“genito-urinary” or “gastric
ulcer”. If additional
information is not available,
then select a term to
reflect the information
that is known, i.e., LLT Pain
45
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Vague Information
• First, try to obtain more specific information
Reported
Turned green
Patient had a medical
problem of unclear type
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LLT Selected
Comment
Unevaluable event
“Turned green” reported
alone is vague; this could
refer to a patient condition
or even
n to
t a product
p d t (e.g.,
(
pills)
Ill-defined disorder
Since it is known that there
is some
s m form
f m of
f a medical
m dic l
disorder, LLT Ill-defined
disorder can be selected
46
Investigations
• Medical condition vs. investigation result
Reported
LLT Selected
Comment
Hypoglycemia
Hypoglycemia
yp g y
LLT Hypoglycemia
links to SOC
Decreased glucose
Glucose decreased
Metabolism and
nutrition disorders
LLT Glucose
decreased links to
SOC Investigations
47
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Investigations (cont)
• Unambiguous investigation result
Reported
LLT Selected
Comment
Glucose 40 mg/dL
Glucose low
Glucose is clearly
below the reference
range
• Ambiguous investigation result
Reported
His g
glucose was 40
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LLT Selected
Comment
Glucose abnormal
No units have been
reported. Select LLT
Glucose abnormal iff
clarification cannot
be obtained.
48
Investigations (cont)
• Investigation results consistent with diagnosis
Reported
Elevated potassium,
potassium K
7.0 mmol/L, and
hyperkalemia
LLT Selected
Comment
Hyperkalemia
It is not necessary to
select LLT Potassium
increased
• Grouped investigation result terms
Reported
LLT Selected
Increased alkaline
phosphatase,
increased SGPT,
increased SGOT and
elevated LDH
Alkaline phosphatase
increased
SGPT increased
SGOT increased
LDH increased
Comment
Select four individual
terms. A single term
such as LLT Liver
function tests
abnormal should not
be selected.
49
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MSSO’s MedDRA Browsers
• MedDRA
M dDRA Desktop
D kt Browser
B
– Download from MSSO Web site
– View/search MedDRA and SMQs
– Export functionality
• MedDRA Web-Based Browser
– https://www.meddrabrowser.org/dsnavigator/
– Requires specific user ID and password
– Access
A
to
t allll MedDRA
M dDRA versions
i
in
i English
E li h and
d
available EU languages (and Chinese, if subscribed)
– View/search MedDRA and SMQs
– Export functionality
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Browser Demonstration/
A
Approaches
h tto Finding
Fi di
the Best LLT
Assessing the Reported Information
• Consider what is being reported. Is it a:
–
–
–
–
–
–
–
–
–
–
Clinical condition - Diagnosis, sign or symptom?
Indication?
Test result?
Injury?
Procedure?
The type of report will
M di ti error??
Medication
influence the way you
search for a suitable LLT.
Product quality issue?
It may indicate in which
Social circumstance?
SOC you expect to find the
Device issue?
closest match.
Procedural complication?
– Is it a combination of these?
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Coding Example 1
Specificity
The patient suffered from an allergic
reaction to an antibiotic
53
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Coding Example 2
Symptoms
The patient states she has been
experiencing cold sweats
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Coding Example 3
Investigations
Lab results indicate the patient has
increased troponin and increased CPK-MB
55
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Coding Example 4
Medication errors
Patient took drug Y instead of drug X
and became short of breath
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Coding Example 5
Patient demographics
A 2 day old baby was noted to have a
mild fever
57
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Coding Example 6
Indications
A 35 year old woman was taking Drug X
to prevent relapses of multiple sclerosis
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Coding Example 7
Narrative
N
ti vignette
i
tt
A 75-year-old male receiving Drug X for
rheumatoid arthritis developed
symptomatic aortic valve stenosis. The
patient’s medical history is significant for
colon cancer and cigarette smoking. He
underwent an aortic valve replacement
and developed a sternal wound infection
three days post-surgery.
59
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Coding Example 8
Liver failure secondary to Hep B liver
cirrhosis and sepsis leading to shock
(from possible spontaneous bacterial
peritonitis or bowel perforation)
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Assessing the Reported Information
• Liver failure = complication of liver
cirrhosis and Hep B
• Hep
H B = underlying
d l i cause off cirrhosis
i h i
• Liver cirrhosis = complication of Hep B
• Possible spontaneous bacterial
peritonitis or bowel perforation
p
p
=
provisional diagnoses, likely cause of:
• Sepsis
• Shock = complication of sepsis
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Term Selection
• Liver failure
– LLT Liver failure
• Hep
H B liliver cirrhosis
i h i
– No combination term available, select both:
– LLT Liver
Li
cirrhosis
i h i
– LLT Hepatitis B
• Do not use non
non-current
current LLT Hep B
• Query if abbreviation is unacceptable
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Term Selection (cont)
• Sepsis leading to shock
– Combination term available, select:
– LLT Septic shock
• Preserves relationship between the conditions
• Better choice than LLT Sepsis
p and LLT Shock
• Possible spontaneous bacterial
peritonitis or bowel perforation
p
p
– Select both provisional diagnoses:
– LLT Spontaneous bacterial peritonitis
– LLT Bowel perforation
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MSSO-DI-6275-16.0.0
MedDRA Coding “Pearls”
• Fi
First,
t ttry using
i reporter’s
t ’ actual
t l words
d
• Be aware of MedDRA’s specificity
• Exploit MedDRA’s hierarchy – if an LLT
is close to what yyou need,, look at its
“siblings” and “parent”
• Check where the LLT lies in MedDRA
(i.e., check the hierarchy above to be
sure it represents the verbatim term
accurately)
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M dDRA Coding
MedDRA
C di “P
“Pearls”
l ” ((cont)
t)
• Use “top
top-down
down” and “bottom
bottom-up
up” navigation
• Try synonyms Æ if it’s not “renal” try
“kid
“kidney”,
” etc.
t
• Use word stems, e.g., “Pancrea”
• Search different word orders, “and”, “or”
• Use available resources for difficult
verbatim terms (web search, medical
dictionaries, colleagues)
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MedDRA Coding “Pearls” (cont)
• And most important of all… get more
g training!
g
coding
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Summary
IIn thi
this course, we:
• Learned the reasons we “code” data and the
role of a coding terminology
• Reviewed the structure, scope, and
characteristics of MedDRA
• Were introduced to the MedDRA Term
Selection: Points to Consider document and
some off it
its specific
ifi principles
i i l
• Learned basic approaches to coding, including
some coding “pearls”
pearls
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MSSO Contacts
• Web site
– www.meddramsso.com
• E-mail
E
il
– [email protected]
• Telephone
– International AT&T Toll Free: 877.258.8280
– Direct Dial (USA): +1 571.313.2574
• Fax (USA)
– +1 571.313.2345
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