MedDRA® Training Medical Level 1

MedDRA® Training Medical Level 1
MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

Course Objectives To provide an understanding of: MedDRA background
MedDRA’s structure, scope, rules, and conventions MedDRA maintenance Tools and implementation issues Coding with MedDRA

MedDRA Background

What is MedDRA? Med = Medical D = Dictionary for R = Regulatory
A = Activities

MSSO M = Maintenance S = Support S = Services O = Organization

MedDRA and the MSSO International support and development of terminology Foster use of MedDRA through communications and educational offerings “Custodians”, not owners, of the terminology JMO (partner organization for Japanese-language MedDRA) Governed by a Management Board (industry, regulators, multi-national, other interested parties)

Maintenance Organization Structure
ICH Steering Committee User Group Management Board Board of Directors Staff Maintenance Organization Development Maintenance Implementation User Support Communication JMO User Communities Regulatory Authorities Regulated Industries WHO Others

Regulatory Status of Mandate
US FDA MedDRA used in FDA’s internal adverse event database (AERS) since 1997 Proposed Rule for Safety Reporting Requirements (2003): FDA proposes to use MedDRA for postmarketing safety reports Japanese Ministry of Health, Labour and Welfare Electronic reports mandatory from October 2003 MedDRA to be used in Periodic Infection and Safety Reports from April 2004 For medical devices with biological components, infections to be described with MedDRA terms

Regulatory Status of Mandate (cont)
European Union Clinical trial SUSARs (Suspected Unexpected Serious Adverse Reactions) and post-authorization Individual Case Safety Reports (ICSRs) reported to EudraVigilance database require MedDRA (LLT codes, current, or previous version) MedDRA required for adverse reaction terms in Periodic Safety Update Report EU Risk Management Plan: MedDRA to be used to code indications, and risks and interactions (potential and identified)

Regulatory Status of Mandate (cont)
European Union (cont) Summary of Product Characteristics Guideline (October 2005): MedDRA to be used in Undesirable Effects section Volume 9A: Standardised MedDRA Queries (SMQs) recommended for signal detection ICH M4E Guideline on Common Technical Document MedDRA recommended in adverse event summary tables

MedDRA Overview

MedDRA Definition MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation. e.g. in full regulatory process: Clinical studies - Reports of spontaneous adverse reactions and events - Regulatory submissions - Regulated product information

MedDRA Structure System Organ Class (SOC) (26)
High Level Group Term (HLGT) (332) High Level Term (HLT) (1,682) Preferred Term (PT) (17,867) Lowest Level Term (LLT) (65,605)

System Organ Class System Organ Class (SOC)
High Level Group Term (HLGT) High Level Term (HLT) Preferred Term (PT) Lowest Level Term (LLT)

System Organ Class (cont)
Highest level of the hierarchy SOCs identified by: Anatomical or physiological system Etiology Purpose

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

High Level Group Term Subordinate only to SOCs and superordinate descriptor for one or more HLTs SOC Cardiac disorders HLGT Coronary artery disorders HLGT Cardiac arrhythmias HLGT Cardiac valve disorders

High Level Term Subordinate to HLGTs and superordinate descriptor for the PTs linked to it SOC Cardiac disorders HLGT Cardiac arrhythmias HLT Cardiac conduction disorders HLT Rate and rhythm disorders NEC HLT Supraventricular arrhythmias

Preferred Term (cont) PT Characteristics
Represents a single medical concept No limit to the number of LLTs that can be associated with a single PT An identical LLT is created for every PT

Preferred Term (cont) Each PT represents a single medical concept
Terms with two or more concepts Are ONLY found at the LLT level Were “inherited” from other terminologies Are matched with the most clinically relevant PT e.g., “Nausea vomiting and diarrhea” from COSTART is an LLT linked to PT Vomiting in MedDRA

Preferred Term (cont) PT Characteristics (cont)
Each path to a SOC from a PT has exactly one HLT and HLGT (one route) PT  HLT  HLGT  SOC PTs can be represented in multiple SOCs

Examples of PTs SOC = Cardiac disorders HLGT = Cardiac arrhythmias
HLT = Rate and rhythm disorders NEC PT Arrhythmia PT Bradycardia PT Tachyarrhythmia

Lowest Level Term (cont)
LLT Characteristics An LLT has one or more of the following relationships to a PT: Synonym Lexical variant Sub-element Many terms from included terminologies are represented at the LLT level

Lowest Level Term (cont)
LLT Characteristics (cont) Constitutes the entry level of the terminology and is linked to a single PT Can have current or non-current status Culturally unique terms are found at this level

Examples of LLTs SOC = Cardiac disorders HLGT = Cardiac arrhythmias
HLT = Rate and rhythm disorders NEC PT = Arrhythmia LLT Dysrhythmias LLT Arrhythmia NOS LLT Arrhythmia LLT (Non-current) Other specified cardiac dysrhythmias

Non-Current Terms Non-current terms are flagged at the LLT level within MedDRA Not recommended for continued use Retained within the terminology to preserve historical data for retrieval and analysis Terms very vague, ambiguous, out-dated, truncated, or misspelled Terms derived from other terminologies that do not fit MedDRA rules

MedDRA Codes 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 sequentially Supplemental terms are assigned codes

A Multi-Axial Terminology
Multi-axial = the representation of a medical concept in multiple SOCs Allows grouping by different classifications Allows retrieval and presentation via different data sets 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

A Multi-Axial Terminology (cont)
A PT can be associated with one or more SOCs One of the associations is primary; all others are secondary A PT will have one and only one path to any particular SOC MedDRA can express multi-axiality at the PT, HLT, or HLGT level

SOC = Respiratory, thoracic and mediastinal disorders SOC = Infections and infestations HLGT = Respiratory tract infections HLGT = Viral infectious disorders HLT = Viral upper respiratory tract infections HLT = Influenza viral infections PT = Influenza

SOC = Skin and subcutaneous tissue disorders SOC = Immune system disorders HLGT = Allergic conditions HLGT = Angioedema and urticaria HLT = Angioedemas PT = Angioedema

SOC = Endocrine disorders SOC = Metabolism and nutrition disorders HLGT = Glucose metabolism disorders (incl diabetes mellitus) HLT = Diabetes mellitus (incl subtypes) PT = Diabetes mellitus

PTs in the following SOCs only appear in that particular SOC and not in others, i.e., they are not multi-axial Investigations Surgical and medical procedures Social circumstances

Primary SOC Allocation
Every PT is assigned to a Primary SOC Purpose of Primary SOC: Determines which SOC will represent a PT during cumulative data outputs Is used to support consistent data presentation for reporting Secondary SOCs are used for additional scientific analysis

Rule for Primary SOC Allocation
PTs relating to diseases or signs and symptoms are assigned to the SOC that best represents the primary manifestation site Which SOC is the primary? PT: Dry skin PT: Eye pain PT: Nausea

Exceptions for Primary SOC Allocation
Congenital and hereditary anomalies are placed in the SOC Congenital, familial and genetic disorders as their Primary SOC

Exceptions for Primary SOC Allocation (cont)
Infections and infestations are placed in the SOC Infections and infestations as their Primary SOC

Neoplasms are placed in the SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) as their Primary SOC

Cysts and polyps are placed in the prime manifestation site as their Primary SOC

Primary SOC Rule Priority
Priority of the exceptions: 1st: Congenital, familial and genetic disorders 2nd: Neoplasms benign, malignant and unspecified (incl cysts and polyps) 3rd: Infections and infestations

Primary SOC Rule Priority (cont)
Which SOC is the primary? Secondary SOCs? PT Cleft palate PT Hepatitis C PT Encephalitis herpes PT Benign neoplasm of skin PT Nasal polyps PT Congenital rubella infection PT Congenital teratoma

Cardiac disorders vs. Vascular disorders
PT HLT HLGT SOC Arteritis coronary Coronary artery disorders NEC Coronary artery disorders Cardiac disorders (P) Arterial inflammations Vascular inflammations Vascular disorders

Cardiac disorders vs. Vascular disorders (cont)
PT HLT HLGT SOC Haemoptysis Coughing and associated symptoms Respiratory disorders NEC Respiratory, thoracic and mediastinal disorders (P) Cardiac signs and symptoms NEC Cardiac disorder signs and symptoms Cardiac disorders Haemorrhages NEC Vascular haemorrhagic disorders Vascular disorders

Endocrine disorders vs. Metabolism and nutrition disorders
PT HLT HLGT SOC Hyperthyroidism Thyroid hyperfunction disorders Thyroid gland disorders Endocrine disorders Metabolic disorders NEC Metabolism disorders NEC Metabolism and nutrition disorders (P)

Endocrine disorders vs. Metabolism and nutrition disorders (cont)
PT HLT HLGT SOC Diabetes mellitus Diabetes mellitus (incl subtypes) Glucose metabolism disorders (incl diabetes mellitus) Metabolism and nutrition disorders Endocrine disorders (P)

Psychiatric disorders vs. Nervous system disorders
PT HLT HLGT SOC Dementia Dementia (excl Alzheimer's type) Mental impairment disorders Nervous system disorders Dementia NEC Dementia and amnestic conditions Psychiatric disorders (P)

Psychiatric disorders vs. Nervous system disorders (cont)
PT HLT HLGT SOC Trisomy 21 Autosomal chromosomal abnormalities Chromsomal abnormalities and abnormal gene carriers Congenital, familial and genetic disorders (P) Congenital cardiovascular disorders NEC Congenital cardiac disorders Cardiac disorders Mental retardations Cognitive and attention disorders and disturbances Psychiatric disorders Mental impairment disorders Nervous system disorders

Congenital, familial and genetic disorders Example
PT HLT HLGT SOC Cerebral palsy Cerebral disorders congenital Neurological disorders congenital Congenital, familial and genetic disorders (P) Neonatal neurological system disorders NEC Neonatal and perinatal conditions Pregnancy, puerperium and perinatal conditions Congenital and peripartum cerebral disorders Congenital and peripartum neurological conditions Nervous system disorders

Congenital, familial and genetic disorders Example (cont)
PT HLT HLGT SOC Congenital HIV infection Viral infections congenital Infections and infestations congenital Congenital, familial and genetic disorders (P) Congenital neonatal infections Neonatal and perinatal conditions Pregnancy, puerperium and perinatal conditions Retroviral infections Viral infectious disorders Infections and infestations Acquired immunodeficiency syndromes Immunodeficiency syndromes Immune system disorders

Conditions vs. Investigations
PT HLT HLGT SOC Pregnancy test positive Reproductive hormone analyses Endocrine investigations (incl sex hormones) Investigations Pregnancy Normal pregnancy, labour and delivery Pregnancy, labour, delivery and postpartum conditions Pregnancy, puerperium and perinatal conditions Be careful to distinguish between a condition and an investigation or a result of an investigation

General disorders and administration site conditions Example
PT HLT HLGT SOC Application site infection Application and instillation site reactions Administration site reactions Injury, poisoning and procedural complications General disorders and administration site conditions Infections NEC Infections-pathogen class unspecified Infections and infestations (P)

Standardised MedDRA Queries (SMQs)

Definition of SMQ Result of cooperative effort between CIOMS and ICH (MSSO) Groupings of terms from one or more MedDRA System Organ Classes (SOCs) related to defined medical condition or area of interest Included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc., related to medical condition or area of interest Intended to aid in case identification

SMQs in Production - Examples
As of Version 10.1, a total of 55 in production (Many other SMQs in development) Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) Agranulocytosis Anaphylactic reaction Cerebrovascular disorders Convulsions Depression and suicide/self-injury Hepatic disorders Ischaemic heart disease Lack of efficacy/effect Peripheral neuropathy Pseudomembranous colitis Rhabdomyolysis/myopathy Severe cutaneous adverse reactions Systemic lupus erythematosus

SMQ Resources Refer to MSSO Web site for information on SMQs

MedDRA Maintenance

MedDRA Maintenance MedDRA is a user responsive terminology
Subscribers may submit change requests to the MSSO for consideration Per core subscriber: 100 simple change requests per month Changes at the PT level and below in the MedDRA terminology structure Routine: Notified of supplemental change within 7-10 working days Weekly supplemental changes Complex changes above PT level are received all year round. Only implemented in March release.

MedDRA Maintenance (cont)
Twice yearly official updates 1 September X.1 release (Simple changes only) 1 March X.0 release (Complex and simple changes) Current version 10.1 Next version 11.0 in March 2008

MedDRA Rules and Conventions

MedDRA Rules and Conventions
Spelling Capitalization Abbreviations Word order Punctuation NEC NOS MedDRA codes

MedDRA Rules and Conventions (cont)
Preferred Term Lowest Level Term Oedema Edema Anaemia Anemia Haematuria Hematuria Rhinorrhoea Rhinorrhea Rule #1: Spelling is British English at PT level and above NOTE: American spellings are found at the LLT level

Capitalization is done for the first letter of each term, proper names, and abbreviations EXAMPLES: Coughing Adam-Stokes syndrome ECG

Abbreviations of terms that are universally accepted are generally found at the LLT level and are not punctuated EXAMPLES: LVH COPD MRI

Rule #3 (cont): Abbreviations of terms that are universally accepted are generally found at the LLT level and are not punctuated NOT INCLUDED: MVA (Motor vehicle accident) H/H (Hemoglobin/Hematocrit) BRBPR (Bright red blood per rectum)

Natural word order is maintained at the PT level and above EXAMPLES: Chest pain Drug toxicity Myocardial infarction Nasal congestion

Rule #4 (cont): Natural word order is maintained at the PT level and above EXCEPTIONS: Rhinitis atrophic Rhinitis seasonal Rhinitis ulcerative EXCEPTION: Word order exceptions in PTs allow similar terms to be grouped together for display in alphabetical tables

Punctuation is only used in the following instances: Apostrophes are used in proper names Hyphens are included in some terms EXAMPLES: Parkinson’s disease Mallory-Weiss syndrome Guillain-Barre syndrome NOTE: Diacritical marks have been excluded from the English version

NEC (Not Elsewhere Classified) is used to denote groupings of miscellaneous terms that do not readily fit into other hierarchical classifications within a particular SOC HLT Bladder disorders NEC Preferred Terms Bladder stenosis Bladder granuloma Bladder telangiectasia

NOS (Not Otherwise Specified) is used (at the LLT level only) when the reported verbatim is not specific EXAMPLES: Biopsy NOS Ear infection NOS Laryngitis NOS Vision abnormal NOS

MedDRA codes are assigned to each term within the terminology Unique Non-expressive 8 digit numeric value Never reused EXAMPLES: Back ache Back pain Musculoskeletal and connective tissue signs and symptoms NEC Musculoskeletal and connective tissue disorders NEC Musculoskeletal and connective tissue disorders

Body site Abdominal wall is gastrointestinal structure E.g., PT Abdominal wall disorder Chest wall is musculoskeletal structure E.g., PT Chest wall necrosis

Body site (cont) Eyelid terms – in general, linked primarily to SOC Eye disorders and secondarily to SOC Skin and subcutaneous tissue disorders E.g., PT Eyelid oedema Pharynx and diaphragm are respiratory structures E.g., PT Pharyngeal erythema, PT Diaphragmatic hernia

General word usage In general, “cervical” terms = neck; “cervix” terms = uterine cervix Except if “cervical” could only refer to uterine cervix For “cervical” term related to uterine cervix, term may be qualified with the word ‘uterine’ “Dilation” = procedure; “dilatation” = disorder E.g., LLT Vasodilation (PT Vasodilation procedure)

General word usage “Drainage” = procedure; “discharge” = disorder E.g., PT Biliary drainage is a procedure; PT Urethral discharge is a disorder Some exceptions made for “drainage” terms that fall outside the realm of procedures. E.g., PT Hydrocele drainage test is in SOC Investigations. “Failure” and “insufficiency” are synonyms in MedDRA E.g., LLT Ventricular insufficiency linked to PT Ventricular failure

General word usage (cont) “Tumo(u)r” = neoplastic; “mass” and “lump” = non-neoplastic Congenital and acquired conditions More common form of a disease/condition is at PT level without qualifier (e.g., PT Hypothyroidism) Less common form also at PT level but with qualifier (e.g., PT Congenital hypothyroidism)

General word usage (cont) Polyp terms Existing unqualified “polyp” terms are classified as benign (e.g., PT Gallbladder polyp) Newly added “polyp” terms will not have qualifier and will be classified as benign No longer adding “malignant polyp” terms to MedDRA; use “malignant neoplasm” term for coding

Issues for Consideration

Tools to Support Use of MedDRA
Formats Electronic Browser Good facilitation Ability to view the terminology Typically, does not support coding for large batches of data A MedDRA subscription will provide a flat ASCII file.

Impact of MedDRA Implementation
Evolving terminology issues Training Who? When? Where? What type of training? Different versions How often do you update? Legacy data?

Impact of MedDRA Implementation (cont)
Evolving terminology issues Internal synonym lists Do you maintain a company specific/project specific synonym list? How often will you update your synonym list? Tools Do you have an autoencoder or browser? Can you run multiple versions of MedDRA at one time?

MedDRA Browser Demonstration and Instruction

Coding Exercises

Scope of MedDRA OUT IN Drug product terms Frequency qualifiers
Diseases Diagnoses Signs Symptoms Therapeutic indications Investigation names & qualitative results Medical & surgical procedures Medical, social, family history Numerical values for results Patient demographic terms Terms from: COSTART© WHO-ART© HARTS© J-ART© Severity descriptors Clinical trial study design terms Equipment, device, diagnostic product terms

Included in MedDRA Symptoms
The patient states she has been experiencing headaches, dizziness and vertigo. _______________ LLT  _______________ PT

Included in MedDRA Symptoms
A 24 year old was admitted to the hospital for abdominal pain, nausea, vomiting, and diarrhea (gastroenteritis). _______________ LLT  _______________ PT OR

Included in MedDRA Signs
Lab results indicate an increase in erythrocytes. _______________ LLT  _______________ PT

Included in MedDRA Diagnoses
A teenager was admitted to the hospital and later diagnosed with appendicitis. _______________ LLT  _______________ PT

Included in MedDRA Diseases
A 65 year old male who has been on diabetic medication for two years was diagnosed with Alzheimer’s disease. _______________ LLT  _______________ PT

Included in MedDRA Therapeutic indications
PC, a 44 year old diabetic, was started on an oral diabetic medication for non insulin-dependent diabetes mellitus. _______________ LLT  _______________ PT

Included in MedDRA Medical/surgical procedures
A 40 year old male had a colon polypectomy performed last week. _______________ LLT  _______________ PT

Included in MedDRA Medical/surgical procedures
As part of his new health maintenance lifestyle, the 50 year old male had his first colonoscopy. _______________ LLT  _______________ PT

Included in MedDRA Medical/social/family history
LJ, a 55 year old female, is a heavy smoker and suffers from alcohol abuse. _______________ LLT  _______________ PT

Included in MedDRA Investigation names/qualitative results
Lab results indicate the patient has increased SGOT and increased SGPT. _______________ LLT  _______________ PT _______________ LLT  _______________ PT

Terminologies Included
The following terminologies are included in MedDRA COSTART (Fifth Edition) WHO-ART (98:3) J-ART (1996) HARTS (Release 2.2)

Issues of Inclusion within MedDRA
Terms may not be at the same level in MedDRA as they are in previous terminologies WHO-ART & COSTART: Fever (PT) MedDRA: Fever (LLT)

Excluded from MedDRA Frequency qualifiers
Patient discontinued her study medication because she was experiencing frequent nose bleeds. _______________ LLT  _______________ PT

Excluded from MedDRA Frequency qualifiers - Exception
Patient experienced frequent bowel movements after eating chili. _______________ LLT  _______________ PT

Excluded from MedDRA Numerical values for results
Blood tests of a 32 year old patient showed hemoglobin of 9.0 g/dl and hematocrit of 28.1%. _______________ LLT  _______________ PT

Excluded from MedDRA Numerical values for results - Perceived Exception Diagnostic tests reveal the patient has lung cancer stage I. _______________ LLT  _______________ PT

Excluded from MedDRA Severity descriptors
The patient states she has been experiencing severe abdominal cramps for the past two days. _______________ LLT  _______________ PT

Excluded from MedDRA Severity descriptors - Exception
During a recent trip to the Alps, a 78 year old with an extensive medical history noticed increased shortness of breath. _______________ LLT  _______________ PT

Excluded from MedDRA Drug product terms
A three year old boy was admitted for loratadine toxicity after accidentally ingesting the remaining tablets in the bottle. _______________ LLT  _______________ PT

Excluded from MedDRA Drug product terms - Exception
An elderly man on digoxin was brought to the hospital and was diagnosed with digoxin toxicity. _______________ LLT  _______________ PT

A 15 year old girl’s acetaminophen blood levels were noted to be two times the normal. _______________ LLT  _______________ PT

Excluded from MedDRA Drug product terms
A patient with a history of codeine abuse was excluded from the study. _______________ LLT  _______________ PT

ABC admitted herself to a drug rehabilitation facility due to her cocaine abuse. _______________ LLT  _____________ PT

Excluded from MedDRA Equipment, device, diagnostic product terms
A 32 year old female had a contraceptive implant in her left arm. On a follow-up visit, the insertion site was noted to be infected. _______________ LLT  _______________ PT

Excluded from MedDRA Device failure terms
A diabetic patient attempting to inject himself with insulin broke the syringe. _______________ LLT  _______________ PT

Excluded from MedDRA Device failure terms - Exception
An 80 year old male experienced a cardiac pacemaker malfunction. _______________ LLT  _______________ PT

Excluded from MedDRA Patient demographic terms
A 39 year old male patient states he has noticed a decrease in libido. _______________ LLT  _______________ PT

Excluded from MedDRA Patient demographic terms - Exception
A 45 year old female patient was diagnosed with breast cancer. _______________ LLT  _______________ PT

Excluded from MedDRA Clinical trial study design terms
In a double blind study, the patient complained of persistent sneezing. _______________ LLT  _______________ PT

QUESTIONS ?

MSSO Contacts Mail Telephone Fax Products and Services VAR1/MSSO
12011 Sunset Hills Road Reston, VA, USA Telephone Toll-free Worldwide (AT&T) Fax Products and Services

MSSO Contacts (cont) To Subscribe by Help desk E-mail Web site Phone
Web site click on “Subscribe to MedDRA” Help desk Phone International AT&T Toll Free: Direct Dial (USA):

Acknowledgements MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) COSTART Thesaurus Fifth Edition Copyright 1995 US Food and Drug Administration (FDA) Hoechst Adverse Reaction Terminology System (HARTS)© 1992 Aventis Pharma ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification, Copyright© 1998 Medicode, Inc. Japanese Adverse Reaction Terminology (J-ART), is a product of the Japanese Ministry of Health, Labour and Welfare (MHLW) WHO Adverse Reaction Terminology (WHO-ART), Copyright World Health Organization Collaborating Centre for International Drug Monitoring

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