Coding is the translation
of medical information relating to a patient's encounter with a health care
provider into alphanumeric code.
Coding plays a very
important role in establishing and converting the clinical and medical
information into a code which helps us to save time and space.
Different Types of Coding
System are:-
- MedDRA-Medical
Dictionary for regulatory activities.
- WHODRL-
WHO Drug Reference List .
- COSTART-
Coding Symbols for the Thesaurus of Adverse Reaction Terminology.
- WHO-ART-
WHO Adverse Reaction Terminology.
- HARTS-
Hoechst Adverse Reaction Terminology System.
- ICD-
International Classification of Diseases.
- ICD-9-CM
International Classification of Diseases, 9th Revision, Clinical
Modification.
The Medical Dictionary for
Regulatory Activities (MedDRA) Terminology is the international medical
terminology developed under the sponsorship of the International Conference on
Harmonisation (ICH) of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
The MedDRA terminology applies to all phases of drug development, excluding animal
toxicology. It also applies to the health effects and malfunction of
devices.
The Categories of terms Classified as medical for these purposes are as
follows:
• Signs.
• Symptoms.
• Diseases.
• Diagnoses.
• Therapeutic Indications.
• Names and Qualitative Results of Investigations.
• Surgical and Medical Procedures.
• Medical / Social/ Family History.
The five-level structure of this terminology provides options for
retrieving data by specific or broad groupings, according to the level of
specificity required.
Structural
Elements of the Terminology
Coding Process:
1.
Auto coding:-The term recorded by
investigator gets coded automatically.
2.
Manual Coding:-When autocoder fails to
code the term. All terms has to be coded manually.
Computer supported step
Uses Autocoders to try
and match at least some codes automatically :
1.
Autocoder provides
minimal support and company does not update dictionary tables when making a
manual assignment.
2.
Autocoder makes all the
updates to the data record and the company updates dictionary tables when
making a new assignment of a code to a term.
Coding Process Steps:
A .Coding process with minimal Autocoder support:
- Collect and store the reported term.
- Run Autocoder.
- If a code is found, Autocoder stores the result.
- If a code is not found, Autocoder flags the term for manual coding.
- Manual review of uncoded terms either assigns a code by updating the record.
- Registers a discrepancy on the reported terms.
B. Coding process with
heavy reliance on Autocoder:
- Collect and store the reported term.
- Run Autocoder.
- If a code is found, Autocoder stores the result.
- If a code is not found, Autocoder stores the term for manual coding.
- Manual review of uncoded terms assigns a code in a separate table.
- Registers a discrepancy on the reported term.
- Rerunning the Autocoder, then finds a match.
Advantages
- Saves Time.
- Saves Money.
- Fastens the approval process.
- Standardize the reported term.
- Multilingual Terminology.
- Facilitates communication between Industry and Regulators.
Challenges:-
- Illegible verbatim.
- Spelling errors.
- Use of abbreviation.
- Multiple medications recorded.
- Non-contributing words which would require common text transformation.
The More Common text
Transformations are:
- Capitalization.
- Removal of selected punctuation, symbols, and extra spaces.
- Removal of numbers and numeric words.
- Removal of dates and date words.
- Removal of noncontributing words.
- Replacement of words with standard terms.
- Alphabetizing the phrase.
Reference:
MedDRA
Introductory Guide.