adverse reaction terminology

1. WHO-ART & MEDDRA
Dr. Plessan Joy
GMC Kottayam

2. 2
WHO Adverse
Reaction Terminology
– WHO-ART

3. 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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4. Four-level hierarchical structure
System Organ Class (SOC)
└ High Level Term (HLT)
└ Preferred Term (PT)
└ Included Term (IT)
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5. 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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6. 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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7. 7
• Preferred terms
used to describe adverse drug reactions.
at the input side
• Included terms
terms closely related to Preferred terms.
used to assist in finding the corresponding PT

8. Record number system
• PTs
a 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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10. 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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13. 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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14. MEDDRA
(MEDICAL DICTIONARY
FOR REGULATORY ACTIVITIES)

15. What is MedDRA?
Med = Medical
D = Dictionary for
R = Regulatory
A = Activities
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16. 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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17. 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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18. Scope of MedDRA
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Medical conditions
Indications
Investigations (tests, results)
Medical and surgical procedures
Medical, social, family history
Medication errors
Product quality issues
Device-related issues
Pharmacogenetic terms
Toxicologic issues
Standardized queries
Not a drug
dictionary
Not an equipment, device,
diagnostic product dictionary
Clinical trial study
design terms
Patient
demographic
terms
Frequency
qualifiers
Numerical values
for
results
Severity descriptors
IN
OUT

19. MedDRA Definition
MedDRA is a clinically-validated international medical
terminology used by regulatory authorities and the
regulated biopharmaceutical industry.
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20. 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)

21. 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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23. 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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24. 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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25. A Multi-Axial Terminology
Multi-axial = the representation of a medical concept of a
PT in multiple SOCs
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26. A Multi-Axial Terminology (cont)
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SOC = Respiratory, thoracic and
mediastinal disorders
HLGT = Respiratory tract
infections
HLT =Viral upper respiratory
tract infections
HLT = Influenza viral
infections
HLGT = Viral infectious
disorders
SOC = Infections and
infestations
PT = Influenza

27. 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

28. 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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29. 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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30. 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.

31. 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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32. Regulatory Status (cont)
•European Union
• Mandatory
• EudraVigilance database
• Good pharmacovigilance practices (GVP) specifically
mention MedDRA
UMC
Using Meddra
MSSO-DI-6225-17.0.0
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