CODING MANAGEMENT

(Part II)

Recap

• Coding• What are Coding Dictionaries• Structure of Dictionaries• Different Forms of Coding• How Organizations Handle Coding?• Challenges• Dictionary Types• Process of Coding

Dictionary Types

COSTART --Coding Symbols for a Thesaurus of Adverse Reaction Terms

MedDRA--Medical Dictionary for Regulatory Activities

WHODRL -- World Health OrganizationDrug Reference List

WHOART-- World Health Organization Adverse Reactions Terminology

ICD-9-CM-- International Classificationof Diseases, Ninth Revision, Clinical Modification

MedDRA

– Medical Dictionary for Regulatory Activities

– Replaces WHO-ART, ICD-CM, CoSTART

WHO Drug

– Replaces BNF dictionary

What Does The Future Hold For What Does The Future Hold For Dictionaries?Dictionaries?

What is the impact of MedDRA and WHO-Drug?– No misspelled verbatim terms– Industry standards– Outside governance w/ periodic

updates

What Does The Future Hold For What Does The Future Hold For Dictionaries?Dictionaries?

ICD-9-CMICD-9-CM________________________________________

InternationalInternationalClassification ofClassification ofDiseases - 9th EditionDiseases - 9th EditionClinically ModifiedClinically Modified________________________________

- Cause of Death - Cause of Death - Medical History- Medical History- Concomitant Illness- Concomitant Illness- Primary Diagnosis- Primary Diagnosis- Secondary - Secondary DiagnosisDiagnosis- Subject Drug - Subject Drug IndicationsIndications-Non Drug Non Drug TreatmentTreatment

WHO - ARTWHO - ART__________________________________________

World HealthWorld Health Organization - Organization - Adverse Reaction Adverse Reaction TerminologyTerminology

________________________- - Adverse EventsAdverse Events

• SeriousSerious• Non-SeriousNon-Serious-Maps to COSTART -Maps to COSTART for for reporting purposesreporting purposes

BNFBNF______________________________________

British British National National FormularyFormulary

______________________________

- Study Drugs- Study Drugs- Concomitant - Concomitant Drugs Drugs -Previous DrugsPrevious Drugs

A Sample of Encoding level terms from this category shows:

M = Terms accepted as misspellings

Q = Terms that no longer encode

Terms that no longer encode (Q’d terms) are terms that were acceptable at

one time, but due to convention changes are no longer acceptable. Or they can be

terms which were accepted in error and need to be “shut off”.

Central & Periph. Nerv. Central & Periph. Nerv.

HeadacheHeadache

Head discomfortHead discomfort

Head painHead pain

Head pressureHead pressure

AutoencodingAutoencoding

–Once data from the case report form has Once data from the case report form has been entered and verified, the Data been entered and verified, the Data Manager begins an electronic autoencoding Manager begins an electronic autoencoding process which compares the text of the process which compares the text of the investigator term in the clinical trial investigator term in the clinical trial database to the text strings stored in the database to the text strings stored in the dictionary databases. When an dictionary databases. When an exactexact match occurs, the code from the term in the match occurs, the code from the term in the dictionary database is automatically entered dictionary database is automatically entered into the clinical trial database. The term is into the clinical trial database. The term is considered “autoencodedconsidered “autoencoded”.”.

How Does The Dictionary Process How Does The Dictionary Process work?work?

Three potential dispensations can be Three potential dispensations can be assigned:assigned:

• AcceptedAccepted: the term is added to the central dictionaries : the term is added to the central dictionaries and will be available for autoencoding the next time and will be available for autoencoding the next time that that exactexact term exists in a database. term exists in a database.

• Accepted as a Misspelled TermAccepted as a Misspelled Term: the term is added to : the term is added to the central dictionaries with a flag of “M” indicating it the central dictionaries with a flag of “M” indicating it is an unambiguous misspelled term. These terms will is an unambiguous misspelled term. These terms will autoencode. autoencode.

• RejectedRejected: as is, term cannot be accepted into the : as is, term cannot be accepted into the central dictionaries. More information is neededcentral dictionaries. More information is needed..

What Happens When A Term What Happens When A Term Doesn’t Autoencode?Doesn’t Autoencode?

Query Writing• Respell – Please correct the spelling of _ to _. Thank

you.

• Clarify as follows_. If reporting _ then please edit or provide a ref/copy of the label. Thank you. (QC:Ref…)

• Clarify as follows _. Are you reporting _? Or _? Or other? If so then please edit or provide a ref / copy of the label. Thank you.(QC: Ref ….)

• Clarify as follows_. Can’t find. Please edit to include accurate trade / ingredient name or provide a ref / copy of the label. Thank you.(QC: Ref ….)

Clarify as follows_. Multiple formulations available. Are you reporting….

Clarify as follows_. Please spell out the abbreviation XYZ . Thank you. (QC: Ref….)

Clarify as follows_. Please edit out symbols/characters from the term and edit as_. Thank you.

Multiple concepts for _. Please split the term ___ into ___ and ___. Thank you

Query Writing

WHO Drug Conventions

• Abbreviations - In general, abbreviations must be completely unambiguous to be coded. If a verbatim term consists only of an abbreviation, the abbreviation is acceptable only if it has one interpretation.

• Misspelled & References to Age/Dates/Years – Not Accepted.

• Foreign Drug spelling are accepted in Who Drug

• Symbols – ® , * , $, -- , @ Not Accepted (*context)

Drug vs. Non Drug - A Drug is swallowed, injected, infused, inhaled, inserted, applied, chewed,A Non

Drug is procedures, non-drug treatment, or devices, Radiotherapy. However, if a drug is named along

with a procedure, then code to the drug named.

Wound dressing/Bandage + Drug = Drug Wound dressing/Bandage - Drug = ALL OTHER

NON- THERAPEUTIC PRODUCTS

(promote healing through absorption) Wound

Dressing/Bandage(support, pressure, compression) = non-drug treatment

WHO Drug Conventions

Generic/Generic—Non-synonyms 1) Verbatim term: “Hydrochlorothiazide and

triamterene” Coding decision:

HYDROCHLOROTHIAZIDE/TRIAMTERENE2) Verbatim term:“Naproxen and misoprostol” Coding decision: Napratec3) Verbatim term:“Codeine and phenytoin” Coding decision:Split the term (There is not a multi-

ingredient entry for this verbatim term and the term cannot be referenced as a marketed combination.)

Generic/Generic----Synonyms 1) Verbatim term: “Paracetamol/Acetaminophen”

Coding decision: PARACETAMOL

Trade/Generic----Synonyms

1) Verbatim term: “Cephalexin—Keflex” Coding decision: KEFLEX

Trade/Generic----Non-synonyms 1) Verbatim term: “Advil - Metronidazole”

Coding decision: Split Trade/Trade----Non-synonyms

1) Verbatim term: “Advil/Tylenol” Coding decision:Split the term

Trade/Trade---synonyms 1) Verbatim term:“Datril/Tylenol” Coding decision:Split the term

18

MedDRA browser

Introduction to MedDRASystem Organ Class (SOC) Organization

The MedDRA Browser

Vertical & Horizontal Hierarchy Mode – Display Features

Includes 16,559 PT

“Repeats”*

Preferred Term (PT) 16,559

System Organ Class (SOC) 26

High Level Term (HLT) 1,681

High Level Group Term (HLGT) 332

Verbatim Term (VT) / (VTB)

Lower Level Term (LLT) / (LLTNC) 61,704*

MedDRA Hierarchy V 8.0

No of concepts (Terms)

Includes 16,559 PT “Repeats”*

Vertical Hierarchy Mode -Horizontal

Display Term Level Details

Horizontal Hierarchy Mode – Display Features

EXAMPLE: LLT SWELLING OF FEET

Searching

• Quick Search

• Search Results may be saved to Microsoft EXCEL

• Advanced Search

Search Types

Quick Search Types:-• Equal• Equal/Contains• Contains/AND• Contains/OR• Contains/Similar• Wild

Quick Search Example Retrieves No Results

• Enter diabete in the Term field• Select the Equal Search Type• Click on Quick Search

– Search retrieves no results– A message is displayed in the MedDRA Search Results window

Quick Search Example Retrieves Results

Example:• Enter typhoid fever in the Quick Search Term

field

• Select the Equal Search Type

• Click on Quick Search button– The results are displayed in the MedDRA

Search Results pop-up window

MedDRA Search Results Window

• View Horizontal Hierarchy of term

• Search results may be saved to Microsoft Excel

Search Results Displayed In Excel

To Save Search Results in EXCEL:• Click on File, Save As• Select the Save in drive• Enter a File name• Select Save as type Microsoft Excel Workbook• Click on Save