MedDRA Basic Concept

Transcription

1 MedDRA Basic Concept Pansie Zhang MSD R&D (China) Co., Ltd 23Apr2015

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Communities (formerly known as SIACs) or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

3 Part A, MedDRA Overview Part B, MedDRA Scope and Structure Part C, Introduction to the Points to Consider Documents 3

4 What is MedDRA? Part A, MedDRA Overview Med = Medical D = Dictionary for R = Regulatory A = Activities MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. 4

5 MedDRA s Purpose Part A, MedDRA Overview * MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). * MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to postmarketing surveillance). 5

6 History Part A, MedDRA Overview No standard international medical terminology Working party of EU regulatory authorities and industry representatives reviewed and amended the UK terminology then called MEDDRA. October ICH adopted MEDDRA Version 1.0 as basis for international terminology. An ICH M1 Expert Working Group was formed to further develop the terminology. February Version 1.0 was released for alpha testing by pharmaceutical companies and regulatory authorities. July ICH agreed to the Version 2.0 and renamed the terminology MedDRA for Medical Dictionary for Regulatory Activities. May ICH Steering Committee established the ICH MedDRA Management Board. November MedDRA Maintenance and Support Services Organization (MSSO) was contracted to maintain and support MedDRA by IFPMA as a trustee of ICH. January Japanese Maintenance Organization (JMO) was established. March Initial version of MedDRA (Version 2.1) was available from the MedDRA MSSO and the Japanese version from the JMO 6

7 MedDRA Maintenance Part A, MedDRA Overview * MedDRA is a user-responsive terminology * Users may submit change requests (CRs) to the MSSO for consideration Each organization: up to 100 CRs per month For simple changes (PT and LLT levels), notification of final disposition within 7-10 working days Complex changes above PT level received all year round. Posted for users comments mid-year. * Twice yearly official updates March September 7

8 advantages Part A, MedDRA Overview The adoption of a dedicated single standardised terminology offers a number of clear advantages for regulators, industry and other stakeholders including healthcare professionals, patients and research organisations: * Removal of the need to convert data from one terminology to another preventing the loss and/or distortion of data and allowing savings in resources; * Improvements in the ease, quality and timeliness of data available for effective analysis, exchange and decision making; * Consistency of the terminology throughout the different stages of the development of a medicinal product allowing effective cross-references and analysis of data; * Facilitation of the electronic exchange of data relating to medicinal products. 8

9 Multilingual MedDRA Part A, MedDRA Overview 9

10 SCOPE Part B, MedDRA Scope and Structure drug OUT Route of administration Patient demographic terms Clinical trial study design terms Numerical value for results Unit of administration Severity descriptions An equipment, device and diagnostic product 10

11 MedDRA Hierarchy Part B, MedDRA Scope and Structure o 26 o 335 o 1721 o o V

12 Lowest Level Term (LLT) LLTs constitute the lowest level of the terminology. Each LLT is linked to only one PT. LLTs have any of the following relationships to their parent PT: Synonyms, Lexical variants, Quasi-synonyms, Subelement, Identical LLT LLT: Worsening of stroke LLT: Cerebrovascular accident LLT: Apoplectic fit LLT: Stroke PT: Cerebrovascular accident LLT: Apoplexy LLT: Late effects of cerebral stroke LLT: Middle cerebral artery stroke 12

13 Preferred Term (PT) A PT is a distinct descriptor for a symptom, sign, disease, diagnosis, therapeutic indication, investigation, surgical, or medical procedure, and medical, social, or family history characteristic. The PT is the level used for AE Summary tables in the CSR PT: Basal ganglia haemorrhage PT: Cerebrovascular accident PT: Embolic stroke PT: Brain stem embolism PT: Basilar artery occlusion HLT: Central nervous system haemorrhages and cerebrovascular accidents PT: Cerebellar ischaemia PT: Cerebral infarction PT: Spinal haematoma PT: Pituitary infarction PT: Middle cerebral artery stroke 13

14 High Level Terms (HLT) An HLT is a superordinate descriptor for the PTs linked to it. The terminology is not a taxonomy, so the specificity of HLTs is not uniform. Intended for data retrieval and presentation purposes. HLTs are subordinate to HLGTs HLT: Central nervous system aneurysms and dissections HLT: Central nervous system haemorrhages and cerebrovascular accidents HLT: Central nervous system vascular disorders NEC HLGT: Central nervous system vascular disorders HLT: Cerebrovascular venous and sinus thrombosis HLT: Transient cerebrovascular events HLT: Traumatic central nervous system haemorrhages 14

15 High Level Group Terms (HLGT) An HLGT is a superordinate descriptor for one or more HLTs related by anatomy, pathology, physiology, etiology, or function. Intended for data retrieval and presentation Subordinate to SOCs No limit to the number of SOCs they can be linked too HLGT: Demyelinating disorders HLGT: Structural brain disorders HLGT: Encephalopathies SOC: Nervous system disorders HLGT: Seizures (incl subtypes) 15 HLGT: Headaches HLGT: Peripheral neuropathies HLGT: Mental impairment disorders HLGT: Neuromuscular disorders HLGT: Neurological disorders NEC HLGT: Nervous system neoplasms benign

16 System Organ Class (SOC) A SOC is the highest level of the hierarchy that provides the broadest concept. Comprise groupings by: Etiology Manifestation site Purpose The exception from the above categories is the Social circumstances SOC which contains information about the person A SOC is related directly to at least one HLGT with no restriction on the number of links to HLGTs. 16

17 Multiaxiality Part B, MedDRA Scope and Structure SOC Infections and infestations HLGT Viral infectious disorders SOC Respiratory thoracic and mediastinal disorders HLGT Respiratory tract infections * Multi-axial = the representation of a medical concept in multiple SOCs Allows grouping by different classifications Allows retrieval and presentation via different data sets HLT Influenza viral infections PT Influenza HLT Viral upper respirratory infections LLT LLT LLT 17 * Purpose of Primary SOC Determines which SOC will represent a PT during cumulative data outputs Is used to support consistent data presentation for reporting to regulators

18 Part B, MedDRA Scope and Structure Rules for Primary SOC Allocation PTs for diseases, signs and symptoms are assigned to prime manifestation site SOC -- Congenital and hereditary anomalies terms have SOC Congenital, familial and genetic disorders as Primary SOC -- Neoplasms terms have SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) as Primary SOC (Exception: Cysts and polyps have prime manifestation site SOC as Primary SOC) Infections and infestations terms have SOC

19 Primary SOC Priority Part B, MedDRA Scope and Structure If a PT links to more than one of the exceptions, the following priority will be used to determine primary SOC: * 1st: Congenital, familial and genetic disorders * 2nd: Neoplasms benign, malignant and unspecified (incl cysts and polyps) * 3rd: Infections and infestations 19

20 System Organ Classes Part B, MedDRA Scope and Structure Blood and lymphatic system disorders Musculoskeletal and connective Cardiac disorders tissue Congenital, familial and genetic disorders disorders Neoplasms benign, malignant and Ear and labyrinth disorders unspecified Endocrine disorders (incl cysts and polyps) Eye disorders Nervous system disorders Gastrointestinal disorders Pregnancy, puerperium and perinatal General disorders and administration conditions site Psychiatric disorders conditions Renal and urinary disorders Hepatobiliary disorders Reproductive system and breast Immune system disorders disorders Infections and infestations Respiratory, thoracic and mediastinal Injury, poisoning and procedural disorders complications Skin and subcutaneous tissue Investigations disorders Metabolism and nutrition disorders Social circumstances 20 Surgical and medical procedures

21 MedDRA Codes Part B, MedDRA Scope and Structure * Each MedDRA term assigned an 8-digit numeric code * The code is non-expressive * Codes can fulfill a data field in various electronic submission types (e.g., E2B) * Initially assigned alphabetically by term starting with New terms are assigned Example: sequentially Gout

22 Overview of MedDRA Term Selection: Points to Consider Document Part C, Introduction to the PtC An ICH-endorsed guide for MedDRA users. Updated in step with new MedDRA versions and is a companion document to MedDRA. Available on MSSO, JMO, and ICH Web sites 22

23 Objectives of this Document Part C, Introduction to the PtC * Objective is to promote accurate and consistent term selection to facilitate a common understanding of shared data * Provides general term selection principles along with tips and examples * Recommended to be used as basis for individual organization s own coding conventions 23

24 Uses of the document Part C, Introduction to the PtC Term selection for adverse reactions/adverse events (ARs/AEs), device-related events, product quality issues, medication errors, exposures, medical history, social history, investigations, misuse and abuse, off label use, and indications is addressed in this MTS: PTC document. The MTS: PTC document does not address every potential term selection situation. 24

25 General Term Selection Principles Part C, Introduction to the PtC Quality of Source Data Quality Assurance Do Not Alter MedDRA Always Select a Lowest Level Term Select Only Current Lowest Level Terms When to Request a Term Use of Medical Judgment in Term Selection Selecting More than One Term Check the Hierarchy Select Terms for All Reported Information, Do Not Add Information 25

26 Term Selection Points Part C, Introduction to the PtC Definitive and Provisional Diagnoses with or without Signs and Symptoms Death and Other Patient Outcomes Suicide and Self-Harm Conflicting/Ambiguous/Vague Information Combination Terms Age vs. Event Specificity Body Site vs. Event Specificity Modification of Pre-existing Conditions Exposures during Pregnancy and 26 Breast Feeding Congenital Terms Neoplasms Medical and Surgical Procedures Investigations Medication Errors, Accidental Exposures and Occupational Exposures Misuse, Abuse and Addiction Transmission of Infectious Agent via Product Location-Specific vs. Microorganism-Specific Infection

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28 MedDRA Training Free Face-to-Face training for users Coding with MedDRA MedDRA: Safety Data Analysis and SMQs Free webinars for users Introduction to MedDRA Coding Basics Introduction to MedDRA Data Analysis and SMQs for Physicians What s New with MedDRA Free videocasts on MedDRA website and YouTube 28

29 Links and Reference The following documents and tools can be found on the MedDRA website: ( MedDRA Introductory Guide MedDRA Change Request Information document MedDRA Web-Based Browser MedDRA Desktop Browser MedDRA Version Report (lists all changes in new version) MedDRA Version Analysis Tool (compares any two versions) MSSO s Recommendations for Single Case Reporting MSSO s Recommendations for Clinical Trial Versioning Transition Date for the Next MedDRA Version 29

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