2. What is Medical coding
1) Medical coding is
classifying terms like
medications, adverse
events, medical history,
disease conditions,
diagnosis with reference to
known standard terms.
2)Assigning a numerical
code to clinical data using
standard , approved
dictionarist and guidelines.
3. Primary Objective of Medical coding
To understand what is coding and why it is required
To understand to be adhered to guidilines
To understand methods of coding and coding process.
To understand different types of dictionaries used in clinical research
To understand about MedDRA and WHO-DD dictionaries
To understand the common problems encountered while coding
4. Need for medical coding in general and
Pharmacovigilance
To classify similar verbatim text into predefined categories
representing medical concepts for generation of statistical
reports
To ensure consistent data classification across all protocols
globally across all projects
To aggregate reported terms in medically meaningful groupings
for the purpose of reviewing and summarizing safety data
To report adverse event terms via individual case safety reports
5. Terms for which medical coding is done
Following text items are coded
l Adverse events(AE) e.g. Headache, Blurred vision
l Concomitant medications e.g. Acetaminophen
l Medical history e.g. Hypertension, Diabetes.
l Surgical and investigational procedures: e.g.
Angioplasty.
6. Minimum standards for medical coding
To Select dictionaries that meets project and regulatory requirements
To understand to be adhered to
To understand methods of coding and coding process.
To understand different types of dictionaries used in clinical research
To understand about MedDRA and WHO-DD dictionaries
To understand the common problems encountered while coding
7. Methods of medical coding
1)Auto encoding: Auto encoding is an electronic process which compares the text of
the investigator term in the clinical trial database to the text strings stored in the
dictionary databases
2) Manual Coding: Terms that are not coded by the auto encoder are coded manually
by the medical coders using standard dictionaries
8. Dictionary category
l Dictionaries are hierarchical code files
l Dictionaries are of two types
1) Standardized dictionaries
2) Published classification systems
9. Standardized dictionaries
1) MedDRA(Medical dictionary for regulatory activities)
2) WHO(World health organization-Drug Dictionary)
MedDRA: The terms that used to code from MedDRA
are as follows:
a) Signs and symptoms
b) Diseases
c) Diagnosis and therapeutic indication
d) Surgical and medical procedures
e) Medical history
WHO DD: Study drugs, concomitant drugs are used to code
10. Published classification system
1) ICD-10-CM(International classification of diseases, ninth revision
clinical modification)
2) WHO-ART(World health organization-Adverse Reactions
terminology)
3) BNF(British National formulary)
ICD-9-CM : The terms that used to code from MedDRA are as follows:
a) Cause of death
b) Medical History
c) Concomitant illness
d) Primary diagnosis
e) Secondary diagnosis
WHO-ART: Adverse events and serious adverse events
BNF: Study drugs, concomitant drugs, previous drugs
12. WHODD HEIRARCHY
Anatomical Main group(Alimentary tract and metabolism)
Therapeutic sub group(Drugs used in diabeties)
Pharmacological sub group(Blood glucose lowering drugs e.g. insulin
Chemical subgroup( Bigaunides)
Chemical substance (Metformin)
