Standardized and MedDRA Queries

MedDRA

1. MedDRA and Standardized Queries Name : R ajat Garg Project submitted in the partial fulfilment for the award of the degree of Bachelor of Pharmacy (2018-2022)

2. What is MedDRA MedDRA ( Medical Dictionary for Regulatory Activities) is a clinically validated international medical terminology dictionary thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing to post-marketing and for safety information data entry, retrieval, evaluation, and presentation.

3. APPROVAL Clinical Trials of Drug under Development

4. Time saving Number of medication error terms in MedDRA has significantly increased MSSO is working Incorporate product quality MedDRA continues to gain momentum in the ICH regions . Characterstics of MedDRA

5. History of MedDRA As late as the early 1990s, there was no single international standard for reporting adverse events. In the USA, the coding symbols for thesaurus of adverse reaction terms COSTART had been widely used. In Europe and other places in the world, the World Health organization adverse reaction terminology WHO-ART was frequently used. The Japanese Ministry of Health, labour and Welfare (MHLW) had developed the Japanese adverse reaction terminology(J-ART). Before MedDRA, there was a general lack of specificity in most of these older terminologies, which limited their usage for other purposes besides encoding adverse events . In the Mid-1990s, an ICH working group was formed M1 EWG to address the need for a standard terminology for regulatory purposes. The EWG worked on an existing terminology used by the British regulatory agency, refining and testing its capabilities in representing reported adverse events. By near the end of the 20 th century, they achieved their goal, and 1 st version of MedDRA was released in 1999 .

6. Scope of MedDRA OUT

7. Implementation of MedDRA All regulatory members of ICH are expected to implement MedDRA within 5 years. As of 2020, the following ICH Regulatory Members have implemented MedDRA; EC, Europe; FDA, United states; HSA, Singapore; Health Canada, Canada; MHLW/PMDA, Japan; Swiss medic, Switzerland. Information about the implementation status of MedDRA by ICH Regulatory Members is updated by ICH on its website ( https://www.meddra.org/ )

8. Organization of MedDRA

9. LLT PT Primary SOC Eye irritation Eye irritation Eye disorders Product appearance cloudy Liquid product physical issue Product issues Product contamination foreign material Product contamination physical Product Issues Continue….

10. Maintenance of MedDRA MedDRA is hierarchical multi-axial, multilingual, regularly-updated, and strictly maintained by the Maintenance and Support Services Organization ( MSSO

11. Development Of MedDRA

12. Application of MedDRA MedDRA’s granularity is helpful for accurate representation of individual events and relative easy matching of verbatim information, there is a flip-side to its specificity, with over 18000 PTs - the concept or analysis level of the terminology – it can be challenging to identify and aggregate related terms. For example, MedDRA has four separate PTs relating to myocardial infarction: PT Acute myocardial infarction, PT myocardial infarction, PT Post procedural myocardial infarction, and PT Silent myocardial infarction .

13. Another characteristic of MedDRA that can present challenges in data retrieval is the multi-axial nature of the terminology. Multi-axiality means that a PT may be assigned to more than one SOC, and its purpose is to allow terms to be grouped by different classifications (e.g. by etiology or site of effect), allowing retrieval and presentation by different datasets. For example. PT Pneumonia is linked to two different SOCs: its primary linkage is to SOC infection and infestations and its secondary is SOC Respiratory thoracic & Mediastinal disorders.   CONTINUE….

14. Multiaxial Structure

15. Signal Detection

16. MedDRA Coding and codes MedDRA coding was developed in the late 1990 s by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). MedDRA coding facilitates the exchange of clinical information through Standardization. MedDRA codes refer to the eight-digit number assigned to each term. A code is assigned to all terms across all categories. Example 10019211(Headache)

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18. Challenges to using MedDRA

19. Future prospective of MedDRA MedDRA will be a great place to start because the definition of similar terms often differ only slightly. As MedDRA continues to be refined by the biopharmaceutical users, other parties have expresses an interest using and refining MedDRA for related users. Recently, the number of medication error terms in MedDRA has significantly increased as Regulatory Authorities focus attention on these issues companies that manufacture medical device.

20. Discussion MedDRA is a rich and highly specific standardized medical terminology developed by ICH to facilitate of sharing of regulatory information internationally for medical products .

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22. Conclusion Of MedDRA MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multi-axial hierarchy or through the special feature of SMQ. The MedDRA is a multi-axial, five-tiered hierarchical terminology used by Regulatory Authorities and the Biopharmaceutical industry for the coding of clinical data in adverse event/adverse drug reaction reports.

23. List of Abbreviations Sr no. Abbreviation Description 1 MedDRA . Medical Dictionary for Regulatory Activities 2 COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms 3 WHO-ART World Health Organization`s Adverse Reaction Terminology 4 MHLW Ministry of Health , Labour and Welfare 5 J-ART Japanese Adverse Reaction Terminology 6 ICH International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human use 7 EWG Expert Working Group 8 SOC System Organ Class 9 HLGT High-Level Group Terms

24. Thank You