Medical Coding

MEDICAL CODING – (MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES- MedDRA)

The Medical Dictionary for Regulatory Activities (MedDRA) Terminology is the international medical terminology developed under the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In clinical trials, adverse events, medical histories, and concomitant medications (drug names) are usually entered as the free text fields (verbatim terms) in the case report forms. Data in free text format cannot be systematically summarized and analyzed, medical coding becomes necessary to convert the free text fields into categories. Adverse events and medical histories are coded using MedDRA (Medical Dictionary for Regulatory Activities). Drug names (generic or brand names) are coded using WHO-DD (World Health Organization – Drug Dictionary). In early dates, there are different dictionaries available for performing the medical coding. Nowadays, the coding dictionaries are fixed on MedDRA and WHO-DD.
          Both MedDRA and WHO-DD dictionaries are updated periodically - specifically, MedDRA is updated twice a year and WHO-DD is updated four times a year. 

The use of multiple terminologies raised several problems. Using different terminologies at various stages in a product's life complicates data retrieval and analysis, making it difficult to cross-reference data.

In October 1994, the ICH Steering Committee introduced multi-disciplinary regulatory communication initiatives to complement the ongoing safety, quality, and efficacy harmonization topics. These initiatives focused on a medical terminology for regulatory purposes (M1) and electronic standards for the transfer of regulatory information (ESTRI, M2). The ICH adopted these initiatives to recognize the increasing importance of electronic communication of regulatory data and the need for internationally agreed standards. MedDRA Version 2.0 was signed off as the implementable version of the terminology at the ICH-4 conference in July 1997. A change in name and modified acronym were agreed upon at this meeting. Hence, MEDDRA is used for versions up to Version 1.5, while the implementable version (Version 2.0) and future versions are known as the MedDRA terminology.

The current version of MedDRA is version 14.1, which was released in September 2011. MedDRA version updates are released twice a year (March and September). The MSSO serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators.

MedDRA was classified into five categories from the broadest grouping found in System Organ Classes (SOCs) to the maximum specificity found in Lower Level Term (LLTs). The hierarchy of MedDRA is represented as follows:

MedDRA hierarchy


CONCLUSION

The MedDRA is integrated with the clinical trial management software to enhance the auto-encoding of the medical terminology within the system. Auto encoding systems typically use verbatim matching methods whereby a computer program attempts to assign a dictionary term (code) to the raw adverse event term based on matched spellings.
MSSO offers a desktop version of MedDRA for medical terminology coding. It is a beta version and can be downloaded from the MSSO website.

REFERENCES



Student Name: Annem Suhasini

Qualification: MSC

Student ID: 205/1222



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