Medical Coding is assigning codes to Drugs, Diseases, ADR, diagnoses and procedures which help to maintain uniformity during the data management process.
Drug Regulatory agencies and pharmaceutical manufacturers currently use a variety of medical terminologies. This is also called as Thesaurus management system
TMS is a flexible system to store commercial and customized dictionary structure, which enables user to look up and code data from external sources.
Coding helps you to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle to code clinical information. ●Process of classifying the reported terms by using a large list of possibilities is known as coding
List of possibilities or standard terms is known as a dictionary or thesaurus.
Coding Importance
●Pharmaceutical companies that develop new drugs are required to produce reports that document the effects of the drug.
● The data used to produce these reports, including information on health conditions and medications, can be hard to analyze because the terminology is inconsistent.
Benefits of Coding
● Standard Terminology through out the process
● Improve regulatory communications between all involved parties
● Facilitate consistent coding and decrease information loss, thereby enhancing quality review
● Decrease time spent by reviewers on data normalization
● Decrease submission time for PSUR
● Improve product labeling(Cautions).
● Facilitate shift to electronic submissions - pre & post
● Improve epidemiological study on global scale
Common coding dictionaries
● MEDdra -Medical Dictionary for Regulatory Activities
● ICD-9-CM -International Classification of Diseases, Ninth Revision, Clinical Modification
● WHODRUG.
● WHO-ART –WHO Adverse Reaction Terminology
● COSTART - Coding Symbols for a Thesaurus of Adverse Reaction Terms
MEdDra
● Medical Dictionary for Regulatory Activities (MedDRA)
● MedDRA goes beyond simply adverse reactions in that it includes terms that describe diseases; diagnoses; signs; symptoms; therapeutic indications; names and qualitative results of investigations
ICD-9-CM
● ICD-9-CM means International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)
● Collected in areas such as relevant history, concomitant diseases, cause of death, indications, and so on. ICD-9-CM codes are numeric; the code is associated with a preferred term text description of the disease.
● Online dictionary
WHODRUG
● World Health Organization Drug Reference List
● dictionary that enables users to group drugs or compounds typically reported under concomitant or suspect medications
● Has a wide variety of drug names equivalent to the preferred term.
Using auto coders
● Autocoder programs take a reported term and look for an exact match in the terms column of a dictionary table
● work well with drug and disease dictionaries where the reported terms tend to have little variation
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