6253-1501 Whats New-Webinar Feb2012

7/31/2019 6253-1501 Whats New-Webinar Feb2012

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What’s New with

MedDRA Version 15.0and the MSSO

MedDRA ® is a registered trademark of the International Federation

of Pharmaceutical Manufacturers and Associations (IFPMA)



MSSO-DI-6253-15.0.1 ©2012 Northrop Grumman Corporation. All Rights Reserved. 2

MedDRA was developed under the auspices of the International

Conference on Harmonisation of Technical Requirements forRegistration of Pharmaceuticals for Human Use (ICH). Theactivities of the MedDRA Maintenance and Support ServicesOrganization (MSSO) are overseen by an ICH MedDRA Manage-

ment Board, which is composed of the six ICH parties, theMedicines and Healthcare products Regulatory Agency (MHRA)of the UK, Health Canada, and The World Health Organization,and is chaired by the IFPMA.




Topics• What's New with MedDRA Version 15.0

– Summary of changes (including SMQs) – Translation corrections summary

• Pregnancy exposure terms• Pharmacogenetic terms

• Bleeding and haemorrhage terms

• Removal of codes from earlierterminologies

• MVAT update



MSSO-DI-6253-15.0.1 ©2012 Northrop Grumman Corporation. All Rights Reserved.

What's New with

MedDRA Version 15.0




Summary of v15.0 Changes• Change request summary:

– A complex release

– To be released on 1 March 2012

– MSSO considered 1470 change requests,including 195 SMQ requests

• Approved: 1251

• Rejected: 183

• Suspended: 36


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Changes per SOC

22966

-14

73

23

58

55

43 68

118

26

103

7

153

191

39

111

19

150

110

50

23

6

57

27

34

Vascular disordersSurgical and medical procedures

Social circumstances

Skin and subcutaneous tissue disorders

Respiratory, thoracic and mediastinal

Reproductive system and breast disorders

Renal and urinary disorders

Psychiatric disorders

Pregnancy, puerperium and perinatal

Nervous system disorders

Neoplasms benign, malignant and

Musculoskeletal and connective tissue

Metabolism and nutrition disorders

Investigations

Injury, poisoning and procedural

Infections and infestations

Immune system disorders

Hepatobiliary disorders

General disorders and administration site

Gastrointestinal disorders

Eye disorders

Endocrine disorders

Ear and labyrinth disorders

Congenital, familial and genetic disorders

Cardiac disorders

Blood and lymphatic system disorders



Version Report• All changes are listed in the Version Report



Summary of Simple Changes• 38 PTs changed primary SOC assignment

(examples)

PT MedDRA v14.1 Primary SOC MedDRA v15.0 Primary SOC

Vomiting in pregnancy Gastrointestinal disordersPregnancy, puerperium and perinatal

conditionsGenetic polymorphism Metabolism and nutrition disorders

General disorders and administrationsite conditions

Diabetic foot Metabolism and nutrition disorders Skin and subcutaneous tissue disorders

Hypoglycaemic seizure Metabolism and nutrition disorders Nervous system disorders

Dental alveolar anomaly Musculoskeletal and connectivetissue disorders

Gastrointestinal disorders

Imperforate hymenReproductive system and breast

disordersCongenital, familial and genetic

disordersIntra-abdominalhaemorrhage

Vascular disorders Gastrointestinal disorders



Summary of Simple Changes (cont)• 143 LLTs changed primary SOC assignment

– Parent PT changed primary SOC – LLT was moved to a PT with a different primary

SOC from its previous PT (move or demotion)

LLT Name MedDRA v14.1 PT MedDRA v14.1Prim ary SOC

MedDRA v14.1 PT MedDRA v15.0Prim ary SOC

Alveolar maxillaryhypoplasia

Dental alveolaranomaly

Musculoskeletal andconnective tissue

disorders

Dental alveolaranomaly

Gastrointestinaldisorders

Hypoglycemicseizure

Hypoglycaemicseizure

Metabolism andnutrition disorders

Hypoglycaemicseizure

Nervous systemdisorders

Blistering of mouthOropharyngeal

blistering

Respiratory, thoracicand mediastinal

disorders

Oral mucosalblistering

Gastrointestinaldisorders

Orbital tendonitis TendonitisMusculoskeletal and

connective tissuedisorders

Extraocular muscledisorder

Eye disorders



Summary of Simple Changes (cont)• 5 LLTs changed currency (all changed current

non-current)LLT Rat ionale for Currency Change

Bleeding DU Ambiguous abbreviation (DU = duodenal ulcer,

decubitus ulcer, etc.)

Difficulty in walking involving joint,site unspecified

Multi-concept "due to“ term: condition (difficulty inwalking), etiology (joint disorder ) and unqualified

anatomical descriptor (joint, site unspecified)

Difficulty in walking involving lower

leg joint

Multi-concept "due to“ term: condition

(difficulty in walking) and anatomical descriptor(lower leg joint)

Grand multiparity, with currentpregnancy

Two concepts (multiparity and pregnancy)

Supine hypotension Ambiguous; may be a synonym of LLT Supine hypotension

syndrome , or a description of low blood pressure in asupine patient



Summary of SMQ Changes

• No new SMQs added

– Total remains at 86

• 170 approved changes to existing SMQs – One is a modified note for SMQ Hypotonic-

hyporesponsive episode • Minor changes made to SMQ Introductory

Guide



Summary of SMQ Changes (cont)• PT changes to SMQs

– 157 PTs were added to some SMQs• Newly added PTs

• Promoted LLTs

• Criteria: inclusion and exclusion criteria documentedwith each SMQ

– 1 category change (PT Cyanosis in SMQ Anaphylactic reaction )

SMQ PT

Malignancy related conditions Carcinoid crisis

Hepatitis, non-infectious Non-alcoholic steatohepatitis

Psychosis and psychotic disorders Substance-induced psychotic disorder



Summary of SMQ Changes (cont)• PT changes to SMQs (cont):

– 10 PTs were flagged inactive; 1 PT changedfrom inactive to active (examples below)

SMQ PT Old

Status

New

Status

Congenital, familial and genetic disordersGastrointestinalangiodysplasia

Active Inactive

Gastrointestinal obstruction Gastrointestinal hypomotility

Active Inactive

Gastrointestinal perforation, ulcer,haemorrhage, obstruction non-specific

findings/proceduresMechanical ileus

Active Inactive

Gastrointestinal perforation Peritonitis Inactive Active




Translation Corrections• 224 changes to replace misspelled or

mistranslated terms – 40 Chinese

– 103 Dutch

– 70 French

– 10 German

– 1 Portuguese• Dutch changes – user noted inconsistencies

• French changes – efforts by MSSO and HealthCanada to identify and correct issues



Pregnancy Exposure Terms




Pregnancy Exposure Terms• MedDRA v14.1:

– New pregnancy exposure terms added andexisting terms reorganized

– Based on suggestions from Points ToConsider Working Group

– To refer to transmission of various agents

through intimate contact (mother to fetusor newborn, between partners, etc.)

16




Pregnancy Exposure Terms (cont)• MedDRA v15.0:

– Changes to pregnancy exposure termsmade at HLT and HLGT levels

17




Pregnancy Exposure Terms (cont)• MedDRA v15.0 (cont):

– Existing HLGT Chemical injury and poisoning and its HLTs merged to new

HLGT Exposures, chemical injuries and poisoning

– Existing HLT Pregnancy related accidental

exposures and injuries and its PTs mergedto new HLT Exposures associated with pregnancy, delivery and lactation

18




Pregnancy Exposure Terms (cont)• Five PTs were to move from HLT Medication

errors due to accidental exposures to new HLTExposures NEC (excl medication errors due to

accidental exposures) – PT Exposure via blood

– PT Exposure via direct contact

– PT Exposure via partner – PT Exposure via semen

– PT Exposure via vaginal fluid

20




Pregnancy Exposure Terms (cont)• Significant concerns expressed by a MedDRA

user about these moves

• For now, the five terms will remain under HLT

Medication errors due to accidental exposures • Discussion with key parties on placement of

exposure terms to follow

21



Pharmacogenetic Terms




Pharmacogenetic (PG) Terms• Initial group of PG terms added to MedDRA

v14.1

• Criteria for new terms focused on genetic

concepts and factors with potential impact ondrug therapy

• In MedDRA v15.0, changes to PG concepts

were made at HLT level – Also 41 PTs, 8 LLTs added

23




PG Terms – Complex Changes

24

New HLT To HLGT

Acquired gene mutations and otheralterations General system disorders NEC

Gene analyses Cytogenetic investigations




PG Terms – Complex Changes (cont)

25




PG Terms – Complex Changes (cont)

26




PG Terms – Complex Changes(cont)

• Additional changes

– Existing HLT Cell marker procedures moved

from HLGT Immunology and allergy investigations to HLGT Cytogenetic investigations

– Existing HLT Acquired mutations NEC andits PTs merged under new HLT Acquired gene mutations and other alterations

27



Bleeding and Haemorrhage Terms




Bleeding and Haemorrhage Terms• Based on a proactivity request

• “Bleeding” LLTs added under existing “haemorrhage” PTs

– Total 149 LLTs

• In MedDRA, “bleeding” and “h(a)emorrhage” are synonyms

• Examples: – LLT Ear bleeding added to existing PT Ear

haemorrhage

– LLT Eye bleeding added to existing PT Eye haemorrhage

29



Removal of Codes ofOlder Terminologies




Removal of Older Codes

• MedDRA v2.1 included numeric or symbolcodes from earlier terminologies (e.g.,

COSTART, WHO-ART)• Codes linked terms from other terminologies

to similar or identical ones in MedDRA

31




Removal of Older Codes (cont)

32





• Original intent of the codes was for transitionfrom older terminology to MedDRA

• Most organizations have long since migratedto MedDRA

• Older terminology codes in MedDRA have not

been maintained or updated since MedDRA v2.1

33




Removal of Older Codes (cont)• No terms have been removed from

MedDRA – Only codes, symbols of earlier terminologies

• The following have not changed: – MedDRA code assigned to each term

– Structure of the distributed extended ASCIIfiles

• Entries in the distribution files for these earliercodes are empty (i.e., null fields)

34




Removal of Older Codes (cont)• List of MedDRA

terms with thelegacy codes isavailable on MSSO

Web site(meddramsso.com)

35

On r ight hand side of“ Current Subscriber”page





36



MedDRA Version Analysis Tool(MVAT)




MVAT• Released on 10 February 2012

• Tangible result of recommendation from BlueRibbon Panel 6 on versioning (May 2009)

– To help users assess impact of a new MedDRA version on their data

– To facilitate upversioning

• Allows comparison between any two MedDRA versions (including non-consecutive versions)

– E.g., MedDRA v10.1 and MedDRA v15.0

38




MVAT Basics

• How much does MVAT cost?

– Access to MVAT is free to subscribers

• Subscription ID and either subscription

password or Change Request ID (CR ID) areneeded

• Will the Version Report spreadsheet

continue to be produced? – Yes; this will continue to be made available

with each new MedDRA release39




Access to MVAT• Via “Downloads” page on MSSO Web site, or

at https://mssotools.com/mvat/

40




MVAT (cont)

• Tool has three modules:

– Version Report Generator

– Data Impact Report

– Search Term Change

41

Access Version Repor tGenerator f rom home

page




Version Report Generator• New LLTs (including

new PTs)• New PTs

• Promoted LLTs

• Demoted PTs

• LLTs under differentPTs

• LLT (excl PTs) PrimarySOC Changes

• PT Primary SOC

Changes

• MedDRA LLT and PT

Text Changes• MedDRA Code Switches

• Currency Changes

• Complex Changes: new,merged, and renamedHLTs, HLGT, and SOCs

• SMQ Changes• PT Changes in SMQs

42

Result s can be exported t ospreadsheet




Version Report Generator (cont)

43

Click on “ Det ails” …




Version Report Generator (cont)

44




Search Term Change

• Allows user to search individual terms or

MedDRA codes for changes that occurredbetween any two MedDRA releases

45




Search Term Change (cont)

46




Search Term Change (cont)

47




Data Impact Report

• Promoted LLTs

• Demoted PTs

• LLTs under differentPTs

• LLT (excl PTs) PrimarySOC Changes

• PT Primary SOCChanges

• MedDRA LLT and PT

Text Changes• MedDRA Code Switches

• Currency Changes

• Hierarchy Changes

48

Upload PT or LLT terms and/or codes;

generates a set of reports specific to theinput




Data Impact Report (cont)

49





50





51

Click on “ I mpact Det ails” …





52




MVAT Resources• MVAT videocast

– Recorded streaming videocast, in Windows MediaFormat (.wmv):http://www.meddramsso.com/public_videos.asp

– Videocast can also be downloaded• MSSO Help Desk for general and technical

questions: [email protected]

• MVAT FAQs:http://www.meddramsso.com/public_faq_mvat.asp

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MVAT FAQs

54

Find t hese FAQs on t heMSSO Web page:

ht t p:/ / w w w .meddramsso.com/ public_faq_mvat .asp



Thank You

Q&A

6253-1501 Whats New-Webinar Feb2012

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