Coding

• Process of converting verbatim terms (text as written on CRF) to a standard

terminology.

• Data that are coded include ‘Concomitant Medication’, ‘Adverse Events’,

Medical History etc.

• Coding Examples

– Synonymous terms are coded to one term

• ‘Stomach Ache’, ‘Stomach Pain’, ‘Pain Abdominal’ are all coded to

‘Abdominal Pain’

• ‘Low blood pressure coming off bypass’, ‘Drop in blood pressure’,

‘Decreased blood pressure’, are all coded to ‘Hypotension’
– Descriptions that do not alter the meaning of
the medical concept are ignored

• ‘Patient developed a single episode of

spike in temperature’ is coded to ‘Pyrexia’
(fever)

• ‘Patient had a sudden myocardial

infarction’ is coded to ‘Myocardial
infraction’
 Coding Methods
Auto encoding:

 A computer program searches the coding dictionary for a

match between a verbatim term and the dictionary terms.

 In most cases only verbatim terms that are ‘direct

matches’ of those in the coding dictionary are auto coded.

E.g.: The verbatim term “Headache” will get auto coded

to “Headache”
Manual Coding:

 Also called “Interactive coding”

 The coder searches the coding dictionary for a match

between a verbatim term and the dictionary terms.

 Usually for terms that are not ‘direct matches’ of

dictionary terms.

 E.g.: The verbatim term “Patient had headache” will

be manually coded to “Headache”
 Coding Dictionary

• A coding dictionary is a standardized tool

containing standard terms for coding as
per regulatory requirements.
Different Coding Dictionaries:

WHOART- World Health Organization Adverse Reaction

Terminology

COSTART- FDA’s Coding Symbols for a Thesaurus of

Adverse Reaction Terms

MedDRA -Medical Dictionary for Regulatory Activities

Terminology

ICD-International Classification of Diseases

WHODD -World Health Organization Drug Dictionary

 MedDRA

Def: Medical Dictionary for Regulatory

Activities.

• How Large?
– 26 System Organ Classes
– 56 000 terms arranged in a 5-level hierarchy
• Five-Level Hierarchy

– Lowest Level Term (LLT)

– Preferred Term (PT)

– High Level Term (HLT)

– High Level Group Term (HLGT)

– System Organ Class (SOC)

• Constitutes the lowest level of terminology.
• Each LLT is linked to one PT.
• The most specific description.
• LLTs relationship to their parent PT are :
– Synonyms
– Lexical varients (different word forms of the same
expression Ex : full name Vs Abbrev.
– Quasi synonym (includes site description)
 System Organ Class
P S YC H IA TR IC D IS O R D E R S

High Level Group Term

M ood D isorders and D isturbances N E C

High Level Term

E m otional or M ood D isturbances N E C

Preferred Term
E uphoric M ood

Low est Level Term Low est Level Term Low est Level Term
E xcitem ent E xcessive E lation Inappropriately Feeling H appy Inappropriately
 The hierarchy of a Verbatim
• LLT-Migraine
• PT-Migraine
• HLT-Migraine headaches
• HLGT-Headaches
• SOC-Nervous system disorders
 WHO-DD
• World Health Organization Drug Dictionary
• International Classification of Drugs
– Proprietary drug names, active ingredients and
chemical substances are provided with unique
reference numbers
• Drugs are classified and grouped together
– according to active ingredients.
– Anatomical-Therapeutical-Chemical Classification
(ATC -Classification)
• Drugs containing the same active ingredients are
assigned a ‘Preferred Name’

• Usually the active ingredient is the ‘Preferred name’

– Example:
• The ‘Preferred Name’ for Disprin and Aspirin is
‘Acetylsalicylic Acid’
• Crocin and Dolo is Paracetamol
• Multiple-ingredient drug
– The first reported drug name, with a specific
ingredient combination, is chosen as the ‘Preferred
Name’.
– Example:
• the first reported drug to WHODD with the
combination paracetamol and codeine was
‘PANADEINE CO’
• PANADEINE CO is the ‘Preferred Name’ for
paracetamol and codeine combination preparations.
 WHO-DD: ATC Code

• ATC Code = Anatomical-Therapeutic-

Chemical Classification System.

• Drugs can have more than one ATC

Code.
 5-level hierarchy

Level 1……………Anatomical Main Group

Level 2…………Therapeutical Main Group
Level 3……Pharmacological Therapeutical SubGroup
Level 4…………Chemical-Therapeutical Sub Group
Level 5………………Chemical Defined Substance
 Example
• PT-ATC4-ATC3-ATC2-ATC1
• PT- Paracetamol
• ATC4-Anilides
• ATC3-Other Analgesics and Antipyretics
• ATC2-Analgesics
• ATC1-Nervous System
CODING OF MEDICATIONS

• Coding of medication will not include routes

frequency and dosage.

• Eg: Rantac PO 50 mg once daily will be treated as

“Rantac”
• Medication will be coded for trade/brand names.

• If appropriate codes are not found then it will be

coded to its active ingredient/generic equivalent.

• If suitable code is not found, then code to broad

category.

• Ex. Neulasta :Ingre : Filpilgrastim will be coded to

antineoplastic agents.
• No spelling correction will be made unless
these are typing errors.

• If the meaning is ambiguous, code will be

assigned only after strong evidence from
literatures and different search engines.

• Abbreviations will not be corrected

 World Health Organization Adverse Reaction
Terminology (WHOART)

This terminology is widely used by regulatory authorities and

available as paper or electronic versions

It is available in English, French, Spanish, German, Portuguese

and Japanese.

Features:
Four-level hierarchical structure

Open-ended - new terms added as necessary

WHO-ART is updated with MedDRA terms

Computer suitable record number system

WHO-ART is organized according to 32 System Organ
Classes, 180 high level terms for grouping Preferred
Terms ,1930 Preferred Terms for describing adverse reactions,
2758 included terms as synonyms to Preferred Terms.

Each System Organ Class is represented by a four-digit code.

Additional four-digit codes are used to represent Preferred
Terms.
 Definitions
Preferred terms

These are the principal terms used for describing drug

adverse reactions. They are the main terms used at the
input side, but may also be used for output purposes.

High level terms

These are group terms of related or similar conditions,

which are used for easy retrieval of information. All
Preferred terms may not have been assigned a high level
term.
E.g. thrombophlebitis leg and thrombophlebitis arm
represent two different preferred terms but are both
grouped under thrombophlebitis as a high level term.
System-organ classes:

These are groups of adverse reaction Preferred terms

pertaining to the same system-organ, and are for some
purposes used at the output side.

A Preferred term can be allocated to a maximum of three

different system-organ classes, e.g. respiratory depression is
coded both under Respiratory disorders and Central nervous
system disorders.

The allocation of a preferred term to system-organ classes is

fixed and does not change with specific reports. The first
System Organ class listed for each preferred term is
considered the most important one.
Included terms

These are terms closely related to preferred terms.

They are used to assist in finding the Corresponding
Preferred term for proper coding of the adverse
reaction reported.

The complete list of system-organ classes and codes:

Skin and appendages disorders 0100

Musculo-skeletal system disorders 0200
Collagen disorders 0300
Central & peripheral nervous system disorders 0410
Autonomic nervous system disorders 0420
Vision disorders 0431
Hearing and vestibular disorders 0432
Special senses other, disorders 0433
Psychiatric disorders 0500
Gastro-intestinal system disorders 0600
Liver and biliary system disorders 0700
Metabolic and nutritional disorders 0800
Endocrine disorders 0900
Cardiovascular disorders, general 1010
Myo-, endo-, pericardial & valve disorders 1020
Heart rate and rhythm disorders 1030
Vascular (extra cardiac) disorders 1040
Respiratory system disorders 1100
Red blood cell disorders 1210
White cell and RES* disorders 1220
Platelet, bleeding & clotting disorders 1230
 Coding System for a Thesaurus of Adverse Reaction
Terms (COSTART)

This terminology is maintained and distributed by the US Food

and Drug Administration (FDA) and was used by them for drug
safety surveillance prior to the advent of MedDRA.

COSTART—‘Glossary terms’—are represented by long

alphabetic coding symbols.

The expanded coding symbol is called the ‘printed as’ term.

For example: ADENOMA THYR for thyroid adenoma.

Several Glossary terms are typically associated with one Coding

Symbol
Examples of COSTART Glossary terms with
associated COSTART coding symbols

Glossary term Coding symbol

Jaundice hemolytic Anemia hemol
Jaundice hepatocellular Hepatitis
Jaundice neonatal Jaundice neonate
Jaw malformation Anomaly congen MS
Jaw pain Pain
Jitteriness Nervousness
Joint ache Arthralgia
 International Classification of Diseases

This system is a hierarchical classification for statistical

purposes

there is currently extensive use of ICD-9, ICD-9-CM and

ICD-10 in the pharmaceutical regulatory environment

In ICD-9, there are 17 chapters plus two supplementary

classifications

(1)External causes of injury and poisoning

(2)Factors influencing health status and contact with health

services.
The chapter headings are similar to System Organ Classes
example ‘I. Infectious and Parasitic Diseases’,
‘VIII. Diseases of the Respiratory System’, and so on.

Each chapter is divided up into subgroups represented by discrete

three digit codes.

Infectious Diseases are covered by the codes 001–139

, Mental Disorders by codes 290–319.

Within the Infectious and Parasitic Diseases chapter, Cholera is 001,

Typhoid and paratyphoid fevers 002, Other Salmonella infections
003, and so on.

Additional digits are used to represent more specific diseases, so that

001.1 is Cholera due to Vibrio cholerae. The four-digit codes
ending .8 refer to ‘other’ related conditions and .9 refer to conditions
which are ‘unspecified’
ICD-9-CM provides additional specificity by
having five digit codes,

so that Mastoiditis and related conditions are coded

as 383, Acute mastoiditis is 383.0, Acute
mastoiditis without complications is 383.00,
whereas subperiosteal abscess of mastoid is
383.01.
ICD-10 released in 1993, has an alphanumeric hierarchical
coding scheme. ICD-10 comprises three volumes.

The first provides a tabular list including the classification

at three- and four-character levels.

A second volume includes an instruction manual

Alphabetical index is provided in the third volume.

The contents of the chapters are designated by a letter of

the alphabet.
For example, Chapter IV includes Endocrine, nutritional
and metabolic diseases (E00–E90). These cover Disorders of
thyroid gland (E00–E07), Diabetes mellitus (E10–E14).