Who art & med dra

WHO-ART & MEDDRADr. Plessan Joy

GMC Kottayam

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WHO Adverse Reaction Terminology

– WHO-ART

Features

• Four-level hierarchical structure• About 6000 terms• Developed in English with French, Chinese, Spanish and Portuguese translations

• Used by drug regulatory agencies and pharmaceutical manufacturers in many countries

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Four-level hierarchical structure

System Organ Class (SOC)

└ High Level Term (HLT)

└ Preferred Term (PT)

└ Included Term (IT)

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Structure – 2015Q1• 23 SOCs – body organ groups• 339 HLTs – for grouping preferred terms• 2123 PTs – principal terms for describing ADR• 3925 ITs – synonyms to preferred terms

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Definitions and uses• System-organ classes High level terms same organ system at the output side• High level terms PTs qualitatively similar at the output side, e.g. Thrombophlebitis and Thrombophlebitis superficial

represent two different preferred terms but are grouped under Thrombophlebitis as a high level term.

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• Preferred termsused to describe adverse drug reactions. at the input side• Included termsterms closely related to Preferred terms. used to assist in finding the corresponding PT

Record number system

• PTsa record number (Arecno) – eg: 0363 sequence number (Seq) - eg: 001.

• Included terms get • the same record number as their corresponding Preferred

terms, • but with a higher sequence number.

• High level term link (HL LINK)

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Critical Terms• indicated by asterisk. • serious disease states, • particularly important to follow up.

• If a PT is indicated as a Critical Term, its linked ITs are also regarded as Critical Terms.

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Future of WHO-ART• UMC collaboration with terminology MedDRA towards

having one global terminology solution.• the final version, 2015Q1 would continue to fulfil its

purpose until a new terminology solution is available.

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MEDDRA(MEDICAL DICTIONARYFOR REGULATORY ACTIVITIES)

What is MedDRA?

Med = Medical

D = Dictionary for

R = Regulatory

A = Activities

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Key Features of MedDRA• Standardized terminology• International scope – currently available in 11

languages including English, Spanish, French, Chinese, and Japanese

• Developed by International Conference on Harmonization (ICH)

• Managed by Maintenance and Support Services Organization (MSSO) and updated bi-annually with input from users

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Key Features of MedDRA (cont)• Structure facilitates data entry, analysis, reporting, and

electronic communication• Large terminology with > 72,000 terms at lowest level -

allows greater specificity• Approx. 20,000 Preferred Terms, each representing a

unique medical concept

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Scope of MedDRA

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Medical conditionsIndications

Investigations (tests, results)Medical and surgical

proceduresMedical, social, family

historyMedication errors

Product quality issuesDevice-related issues

Pharmacogenetic termsToxicologic issues

Standardized queries

Not a drug dictionary

Not an equipment, device,diagnostic product dictionary

Clinical trial study design terms

Patient demographicterms

Frequency qualifiers

Numerical values forresults

Severity descriptors

INOUT

MedDRA Definition

MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry.

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MedDRA Hierarchy

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System Organ Class (SOC)

High Level Group Term (HLGT)

High Level Term (HLT)

Preferred Term (PT)

Lowest Level Term (LLT)

System Organ Classes

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• 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

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Non-Current Terms

• at the LLT level• very vague, ambiguous, out-dated, truncated, or

misspelled• Terms derived from other terminologies that do not fit

MedDRA rules• Not recommended for continued use• Retained within the terminology to preserve historical

data for retrieval and analysis

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MedDRA Codes• Each MedDRA term assigned an 8-digit numeric code• New terms• Renaming

• When terms are renamed, the code number is reused for the renamed term

• for spelling errors, hyphenation, and parenthesis changes

• When HLT or HLGT terms are removed from the terminology, they are deleted

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A Multi-Axial Terminology

Multi-axial = the representation of a medical concept of a PT in multiple SOCs

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A Multi-Axial Terminology (cont)

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SOC = Respiratory, thoracic and mediastinal disorders

HLGT = Respiratory tract infections

HLT =Viral upper respiratorytract infections

HLT = Influenza viral infections

HLGT = Viral infectious disorders

SOC = Infections and infestations

PT = Influenza

A Multi-Axial Terminology (cont)

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PT = Diabetes mellitus

HLT = Diabetes mellitus (incl subtypes)

HLGT = Glucose metabolism disorders (incl diabetes mellitus)

SOC = Metabolism and nutrition disorders

SOC = Endocrine disorders

Multi-Axial Terminology (cont)• Allows terms to be grouped by different classifications

• Allows retrieval and presentation via different data sets

• Allows an automatic assignment of predefined term groupings

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Primary SOC allocation• PTs are assigned to a prime manifestation site SOC• Eg: Congenital anomalies have SOC Congenital,familial

and genetic disorders

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What is new in MedDRA?• New MedDRA versions are released in March and

September each year.

• The Current version of MedDRA is version 18.0.

Regulatory Status

• US FDA• Used in several databases including FAERS (drugs and biologics),

VAERS (vaccines), and CAERS (foods, dietary supplements, cosmetics)

• Recommended terminology for adverse event reporting in several Proposed Rules

• Not mandatory

• Japanese Ministry of Health, Labour and Welfare• Mandatory use in electronic reporting

MSSO-DI-6225-17.0.0

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Regulatory Status (cont)

•European Union

• Mandatory • EudraVigilance database• Good pharmacovigilance practices (GVP) specifically mention MedDRA

UMCUsing Meddra

MSSO-DI-6225-17.0.0

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