Clinical Coding

Clinical Coding
Agenda
 What is coding
 Types of coding
 To know about coding dictionaries
 Introduction of MedDRA
 Introduction of WHODD
What is Medical coding
 It is a process of converting terms( text as written on

CRF) to a standard terminology
 In Medical coding, diagnosis and procedures are

assigned to categories in their respective taxonomies
Why do we do coding ?
 Reduce the variety of the data in the database
 For the efficient and accurate retrieval of data for

medically meaningful review, summation and analysis
 Clean Medical text in DB
 Automatic classification of medical text data for

summary in tables.
How do we do Coding ?
 It is done making use of coding dictionaries
 Types of the data that are coded making use of coding

dictionaries are :
Adverse events
Medical history
Concomitant medication Concomitant indication
Procedures/surgeries/Events
Investigations, Indications
Social circumstances
What is Coding Dictionary ?
A dictionary is standardized tool containing

standard terms of coding are per regulatory
requirements
Different types of coding dictionaries
 MedDRA: Medical dictionary for regulatory activities

 ICD9CM: International classification of Diseases 9th
revision Clinical Modification
 WHOART: World Health Organization Adverse
Reaction Terminology
 COSTART: FDA’s Coding Symbols to Treasures of
Adverse Reaction Terms
 WHODD/DRL: World health organization Drug
Dictionary/ Drug reference list
Types of Data
 Adverse Events - MedDRA, WHOART & COSTART
 Medical History - ICD9CM, MedDRA
 Indications - MedDRA
 Medication - WHODD/DRL
Coding Methods
 Two Types of Coding
Auto coding
Manual Coding
Coding Methods…..Cont
Auto Coding
 Autocoder programs take a reported term and look for

an exact match in the terms column of dictionary table
 Verbatims which are direct matches are only
autododed.
 Ex Verbatim paracetamol will get autocoded to paracetamol.

Coding Methods…cont
Manual coding
 Also called as Interactive coding, where a coder will

manually assign a suitable code to the verbatim term
making use of the dictionary
 Ex. VT Paracetamol 500 mg will be coded to paracetamol

When do we do Manual coding..?
 Misspelled
 Ambiguous or has more than one medical concept
 Foreign terms not recognized by the dictionary
or irrelevant details /modifiers Acronyms or
abbreviations
 Extraneous attached to the terms
 Drug terms with dosage or formulation attached
 Drug proprietary names that are not yet in the market
 Drug with multiple ingredients but not recognized by
the dictionary
Dictionary Structure
 Each Dictionary has its unique structure
 Each dictionary has a different hierarchical structure

MedDRA….Objectives
 What is MedDRA
 Subscribers
 MSSO
 Uses
 Structure
 Coding
MedDRA
MedDRA = Medical dictionary for regulatory activities
Definition:
MedDRA is a clinically validated international medical

terminology used by regulatory authorities and
regulated biopharmaceutical industry.
MedDRA
 It is developed by International Conference of

Hormonization (ICH)
 It is owned by International federation of

Pharmaceutical Manufactures and Association (IFPM)
Who can subscribe MedDRA..?
 CRO’s
 Pharmaceutical Companies
 Biotechnology companies
 Device Manufactures
 Other support service organizations
 Regulatory authorities
MSSO
 MSSO = Maintenance and support Services

Organization
 MSSO serves as the repository, maintainer, and
distributor of information regarding MedDRA and its
application within the biopharmaceutical industry and
regulators.
 MedDRA is updated by annually with input from
subscribers
http//www.meddramsso.com/MSSOweb/index.htm
MedDRA..Uses
 Coding of Adverse events, Medical histories, surgical histories,

procedures, indications, social circumstances, investigations
 To aggregate reported terms in meaningful grouping for the
purpose of reviewing and/or analyzing safety fo data.
 To facilitate consistent retrieval of specific cases of medical
conditions form a database.
 To include ADR/AE’s in tables, analyses, and line listing for
reports
 Regulatory reporting
 To identify frequency of medically similar events
MedDRA Structure
Five level Hierarchy
 Lowest level term

 Preferred term
 High level term
 High level group term
 System organ class
MedDRA Structure…Cont
LLT
 Low level Term

 Each LLT is linked to one PT
 Used as a basis for Auto coding
 The most specific description
PT
 Super ordinate to LLT and Subordinate to HLT
 Distinct description of single medical concept
 It is preferred for use in regulatory environment
 No prescribed limit to the number of LLT’s that can be
linked to PT
 PT must be linked to as many SOC’s as is
appropriate, but it can be linked to each SOC via one
HLT,HGLT,SOC route
 Each PT should have at least one LLT below it.
HLT
 Super ordinate of PT and subordinate of HGLT

 Links PT’s related to it by anatomy, pathology,
physiology, etiology or function
 HLT must be linked to at least one SOC via HGLT
HGLT
Super ordinate of one or more HLTs
 Related to HLT by anatomy, pathology, physiology,
etiology or function
 Used for only data retrieval presentation
 Groups HLTs to help data retrieval by boarder
concepts
 Must be linked to one SOC’s
 No prescribed limit to the number of SOC’s that can be
linked to HGLT
SOC
 Highest level of hierarchy which provides the

broadest concept of data retrieval
 SOC’s comprise grouping
 Etiology (ex. Infections and infestations)

 Manifestation site (GI disorders)
 Purpose (surgical and medical procedures)
SOC’s
There are 26 SOC’s
1. Blood and lymphatic system disorders
2. Congenital, familial and genetic disorders
3. Cardiac disorders
4. Eye disorders
5. Ear and labyrinth disorders
6. Endocrine disorders
7. Gastrointestinal disorders
8. General disorders and administration site conditions…etc
Cardiac disorders (SOC)
Cardiac and vascular investigations (HGLT)
Cardiac auscultatory investigations (HLT)
Cardiac Murmur (PT)
Cardiac Murmur NOS (LLT)
Cardiac sound abnormality (VT)

 Each MedDRA term has been assigned to 8 digit

numeric code
 The code is non expressive
 Initially assigned alphabetically by term starting with
10000001
 New term are assigned sequentially
 Codes are never reused
MedDRA Multi-Axiality
MedDRA …Pitfalls
 MedDRA is huge, with complex relationships among

terms on the same different levels
 Requires substantial clinical decision making

WHODD
 What is WHODD
 Subscribers
 Who Updates?
 Uses
 Structure
 Coding, ATC
WHODD
Definition
 World health Organization Drug Dictionary (WHODD)
 Also Known as World Health Organization Drug

Reference list (WHODRL)
WHODD…Updates
 Updates are done by

UPPSALA Monitoring Center
 It is located in Uppsala city, Sweden
 It is run by WHO
 Every quarterly a new version is released.
WHODD…Structure
Drugs are classified and grouped together
 According to active ingredients
 Anatomical – Therapeutical – Chemical classification

WHODD…Structure
 Drugs containing the same active ingredients are

assigned a preferred Name
 Usually the active ingredients is the Preferred Name
 Ex. The preferred name for Aspro and Disprin is

Acetyl Salicylic acid.
WHODD…Structure
 It has got the 11 digit code
 The 11 digit code consist of
 Drug Record No – First 6 digits

 Sequence No - Digit 7 & 8
 Sequence No – Digit 9,10 & 11
The 11 digit code is all that is needed to establish links to other

levels.
WHODD…Structure
Code 000001 01 002
 First 6 digit - Record number

- Unique 6 digit code is assigned to the preferred name
- Drugs with same preferred name have same record name
 7 & 8 digit - Sequence No 1

- Differentiates between sat/ester form of the same compound
 9,10, & 11 digit –Sequence No 2

- Differentiates between trade name with the active ingredients
WHODD…Structure
Ex. Ibuprofen
Ibuprofen 001092 01 001
Ibuprofen sodium 001092 05 001
Sadrion N 001092 01 012
001092 is the record number of all preparations

containing Ibuprofen
Seq.1, 05 identifies Ibuprofen sodium as salt form
Seq.2, 012 identifies Soridon N as name of Ibuprofen.
What does Coding Mean to You?
Understanding the concept and principle of coding

means the ability to manage data meaningfully
(accurately and consistently) that contributes to the
building a high-quality database, ultimately resulting in
high-quality data for submission.

Clinical Coding

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Clinical Coding

 To know about coding dictionaries

 It is a process of converting terms( text as written on

 In Medical coding, diagnosis and procedures are

 Reduce the variety of the data in the database

 For the efficient and accurate retrieval of data for

 Clean Medical text in DB

 Automatic classification of medical text data for

 It is done making use of coding dictionaries

 Types of the data that are coded making use of coding

A dictionary is standardized tool containing

 MedDRA: Medical dictionary for regulatory activities

 Adverse Events - MedDRA, WHOART & COSTART

 Medical History - ICD9CM, MedDRA

 Two Types of Coding

 Autocoder programs take a reported term and look for

 Ex Verbatim paracetamol will get autocoded to paracetamol.

 Also called as Interactive coding, where a coder will

 Ex. VT Paracetamol 500 mg will be coded to paracetamol

 Each Dictionary has its unique structure

 Each dictionary has a different hierarchical structure

MedDRA = Medical dictionary for regulatory activities

MedDRA is a clinically validated international medical

 It is developed by International Conference of

 It is owned by International federation of

 MSSO = Maintenance and support Services

 Coding of Adverse events, Medical histories, surgical histories,

Five level Hierarchy

 Lowest level term

 Low level Term

 Super ordinate of PT and subordinate of HGLT

 Highest level of hierarchy which provides the

 SOC’s comprise grouping

 Etiology (ex. Infections and infestations)

Cardiac disorders (SOC)

Cardiac and vascular investigations (HGLT)

Cardiac auscultatory investigations (HLT)

Cardiac Murmur (PT)

Cardiac Murmur NOS (LLT)

Cardiac sound abnormality (VT)

 Each MedDRA term has been assigned to 8 digit

 MedDRA is huge, with complex relationships among

 Requires substantial clinical decision making

 World health Organization Drug Dictionary (WHODD)

 Also Known as World Health Organization Drug

 Updates are done by

Drugs are classified and grouped together

 According to active ingredients

 Anatomical – Therapeutical – Chemical classification

 Drugs containing the same active ingredients are

 Usually the active ingredients is the Preferred Name

 Ex. The preferred name for Aspro and Disprin is

 It has got the 11 digit code

 The 11 digit code consist of

 Drug Record No – First 6 digits

The 11 digit code is all that is needed to establish links to other

Code 000001 01 002

 First 6 digit - Record number

 7 & 8 digit - Sequence No 1