8/3/2020

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MSSO Open Session04 Aug 2020

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8/3/2020

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MSSO Open Session

• Up to 90 minutes– Brief MSSO MedDRA Updates

– Open Session• Answer questions submitted in advance

• Address questions submitted through the Question Panel

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• We might not be able to answer all questions in the time allotted for this session.

• We are unable to address specific coding requests.

** This session is not being recorded**

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MSSO Open Session

• The submitted question will be shown on the screen and read to the group

• An MSSO panelist will respond to the question

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Clarification requests

• If you submitted the question being discussed, please use the Raise Your Handfunction to join the discussion.

• All other attendees, if you have additional follow up or clarification request, please use the GoToWebinar Question function

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GoToWebinar panel

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Panelists 4-AUG-2020

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• Dr. Judy Harrison, Chief Medical Officer

• Dr. Anna Zhao-Wong, Deputy Director of the MSSO

• Dr. David Richardson, Medical Officer

• Dr. Amanda Saunders, Medical Officer

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Panelists 5-AUG-2020

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• Dr. Carol-Ann Wilson, Medical Officer

• Ms. Jane Knight, Clinical Associate

• Dr. Anamika Dutta, Medical Officer

• Dr. François Peterlongo, Medical Officer

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Agenda

• Update of the Points to Consider Companion Document

• Finding the recording of the webinar of your interest

• Questions submitted by the user community

• Any additional questions from participants

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Update on Points to Consider (PtC)

DocumentsDr. Dave Richardson, MD

MSSO Open Session

4 August 2020

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Translation of PtC

Documents

• Full PtC documents are being translated into selected languages to support uptake of MedDRA in new regions

– Chinese, Korean, Spanish

• Based on v23.0 release of PtC documents

• Available by October 2020

• Updated annually in March

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PtC Companion Document

• Release 1.1 made available in July 2020

– Revisions and new examples in medication errors section

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PTC Companion

Document Release 1.1

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Medication Error (ME) Updates in PTC

Companion Document Release 1.1

• Distinguishing device malfunction issues from human factor issues (such as device use errors or wrong technique) when coding MEs involving devices

• Dose omission– Unintentional/error (e.g., forgot to take dose)

– Intentional (e.g., drug held prior to surgery)

– Unspecified/cause unknown

– Therapy interruption (due to non-clinical or external factors such as supply, insurance issues, etc.)

• Several coding examples were added, deleted or clarified

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PtC Companion Document

(cont)

• New section on product quality in final draft stage

– Expected to be available in last quarter of 2020

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Finding the Recording of the

Webinar of Your InterestAnna Zhao-Wong, MD, PhD

MSSO Open Session

4 August 2020

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Frequently Asked

Questions

• Where do I find the recording of the webinar that I attended on xxx?

• Is this webinar available to rewatch?

• How will the recording be shared to the participants?

• I registered the Advanced MedDRA Coding webinar on xxx but I cannot attend due to a schedule conflict, where will the webinar recording be posted?

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Webinar Recordings on

YouTube

• All webinar recordings of past two years are stored in the MSSO YouTube channel

– https://www.youtube.com/c/MedDRAMSSO/featured

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Webinar Recordings on

YouTube (cont)

• “Videos” Tab – all recordings

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Webinar Recordings on

YouTube (cont)

• “Playlists” Tab – recent recordings by trainer

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Webinar Recordings on

YouTube (cont)

• “Discussion” Tab – leave your comments and questions

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Open Session

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How to check other companies’

subscription status if they don’t want to tell

us their MedDRA ID?

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Question 1 –Subscription Verification

MedDRA Data Sharing

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Subscription grants access to MedDRA for one

year

Subscriber cannot grant any

sublicense, publish or otherwise distribute

MedDRA to a third party

Data may be freely exchanged between current

MedDRA subscribers

and with all regulators

Sharing MedDRA with a non-subscribing

organization is a violation of the MedDRA license

Access 3rd Party Distribution Free Exchange Violation

• Why check partner’s subscription?

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MedDRA Data Sharing

Document

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• Download a copy from meddra.org

Subscription Verification

• If you have your partner’s MedDRA ID,

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https://apps.meddra.org/selfservice/

https://www.meddra.org/training-materials

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Subscription Verification

• If you don’t have your partner’s MedDRA ID, email mssohelp@meddra.org.

• Help Desk staff will check the status for you.

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What does LLT Documented hypersensitivity to

administered drug mean and how is it used?

Question 2

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Guidance on the LLT

This medication error refers to the situation when a patient is administered a drug that is documented in the patient's medical file to cause a hypersensitivity reaction in the patient.

– Example: Despite the fact that the patient's medical record indicated "sulfa allergy," the physician prescribed a sulfa antibiotic. Subsequently, the patient took the antibiotic and experienced hives.

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Term hierarchy

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Additional information

• Guidance

– MedDRA® Term Selection: Points to Consider document

– Concept Description in Appendix B of the MedDRA Introductory Guide

– Concept descriptions in the MedDRA browser

• A related term, PT Documented hypersensitivity to administered product, applies to similar situations involving known hypersensitivity to other types of products, not specifically drugs.

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MedDRA Browser

Demonstration

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Question 3

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• How do we code autoimmune events?

• How can we find autoimmune events in our

database more easily?

Coding Autoimmune and

Immune-mediated Events

• Coded like any other event - select the most specific, current LLT from MedDRA

• If immune-mediated/autoimmune sign or symptom is associated with definitive diagnosis, preferred option is to code diagnosis only (MTS:PTC 3.1)

• If greater specificity is desired, user may “split code” when needed. Examples:

- can code “immune-mediated dyspnea” as LLT Immune-mediated adverse reaction and LLT Dyspnea

- can code “autoimmune alopecia” as LLT Autoimmune disorder and LLT Alopecia

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Hierarchy Analysis Tool Exercise

How Many Cases of

Autoimmune Diseases?

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Adverse Event (MedDRA v23.0) No. of cases

SOC Blood and lymphatic system disorders

PT Anaemia 5

PT Autoimmune neutropenia 5

PT Evans syndrome 1

PT Platelet anisocytosis 1

PT Platelet toxicity 2

SOC Cardiac disorders

PT Autoimmune myocarditis 4

PT Myocardial infarction 1

PT Myocarditis 2

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How Many Cases of

Autoimmune Diseases? (cont)

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Adverse Event (MedDRA v23.0) No. of cases

SOC Endocrine disorders

PT Polyglandular autoimmune syndrome type I 2

PT Thyroid disorder 1

SOC Eye disorders

PT Birdshot chorioretinopathy 2

PT Autoimmune uveitis 3

SOC Hepatobiliary disorders

PT Primary biliary cholangitis 3

PT Hepatitis toxic 1

PT Hepatocellular injury 1

How Many Cases of

Autoimmune Diseases? (cont)

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Adverse Event (MedDRA v23.0) No. of cases

SOC Immune system disorders

PT Autoimmune disorder 4

SOC Musculoskeletal and connective tissue disorders

PT Arthritis 1

PT Muscular weakness 2

PT Polymyalgia rheumatica 1

PT Rheumatoid arthritis 3

SOC Skin and subcutaneous tissue disorders

PT Alopecia 1

PT Skin haemorrhage 1

PT Vitiligo 2

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Secondary SOC Analysis

Example

• In my dataset, which terms are autoimmune disorders?

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Primary SOC

Blood and lymphatic system disorders

Cardiac disorders

Endocrine disorders

Eye disorders

Hepatobiliary disorders

Immune system disorders

Musculoskeletal and connective tissue disorders

Skin and subcutaneoustissue disorders

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Your Current Dilemma

• My system only shows the primary SOC hierarchy. How do I view secondary SOC links for a set of terms?

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MSSO’s MedDRA

Browsers• MedDRA Desktop Browser (MDB)

– Download MDB and release files from MedDRA website

• MedDRA Web-Based Browser (WBB)

– https://tools.meddra.org/wbb/

• Mobile MedDRA Browser (MMB)

– https://mmb.meddra.org

• Features

– Each require MedDRA ID and password

– View/search MedDRA and SMQs

– Support for all MedDRA languages

– Language specific interface

– Ability to export search results and Research Bin to local file system (MDB and WBB only)

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MDB and WBB Special

Features

• Preview upcoming (supplemental) changes in next release*

• View primary and secondary link information

• Upload terms to run against SMQs

• Advanced search options (e.g., NOT, OR)

*Supplemental view not available on MDB

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Hierarchy Analysis Tool –

Browser Demonstration

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Secondary SOC Information

• Hierarchy Analysis feature

– Upload terms in spreadsheet

– Export with primary and secondary SOC hierarchies

– No need for programming

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Hierarchy Analysis feature

Secondary SOC Information

(cont)

• Create a properly formatted spreadsheet of your data to upload into the Hierarchy Analysis tool

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Secondary SOC Information

(cont)

• Hierarchy Analysis feature

– Upload terms in spreadsheet

– Export with primary and secondary SOC hierarchies

– No need for programming

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Use “Import Data” option

Secondary SOC Analysis

Example (cont)

• Output sorted by HLGT – there are 11 autoimmune disorders

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Row ID Term Code LevelHLT HLGT SOC Primary

SOC

1 Anaemia 10002034 PT Anaemias NEC Anaemias nonhaemolytic and marrow depressionBlood and lymphatic system disorders Y

7 Myocardial infarction 10028596 PT Coronary necrosis and vascular insufficiencyArteriosclerosis, stenosis, vascular insufficiency and necrosisVascular disorders N

2 Autoimmune neutropenia 10055128 PT Blood autoimmune disorders Autoimmune disorders Immune system disorders N

3 Evans syndrome 10053873 PT Blood autoimmune disorders Autoimmune disorders Immune system disorders N

6 Autoimmune myocarditis 10064539 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders N

9 Polyglandular autoimmune syndrome type I10036072 PT Endocrine autoimmune disorders Autoimmune disorders Immune system disorders N

11 Birdshot chorioretinopathy 10072959 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders N

12 Autoimmune uveitis 10075690 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders N

13 Primary biliary cholangitis 10080429 PT Hepatic autoimmune disorders Autoimmune disorders Immune system disorders N

16 Autoimmune disorder 10061664 PT Autoimmune disorders NEC Autoimmune disorders Immune system disorders Y

19 Polymyalgia rheumatica 10036099 PT Muscular autoimmune disorders Autoimmune disorders Immune system disorders N

20 Rheumatoid arthritis 10039073 PT Rheumatoid arthritis and associated conditionsAutoimmune disorders Immune system disorders N

23 Vitiligo 10047642 PT Skin autoimmune disorders NEC Autoimmune disorders Immune system disorders N

19 Polymyalgia rheumatica 10036099 PT Connective tissue disorders NEC Connective tissue disorders (excl congenital)Musculoskeletal and connective tissue disordersY

7 Myocardial infarction 10028596 PT Ischaemic coronary artery disordersCoronary artery disorders Cardiac disorders Y

9 Polyglandular autoimmune syndrome type I10036072 PT Polyglandular endocrine disordersEndocrine and glandular disorders NECEndocrine disorders Y

5 Platelet toxicity 10059440 PT Poisoning and toxicity Exposures, chemical injuries and poisoningInjury, poisoning and procedural complicationsN

14 Hepatitis toxic 10019795 PT Poisoning and toxicity Exposures, chemical injuries and poisoningInjury, poisoning and procedural complicationsN

3 Evans syndrome 10053873 PT Anaemias haemolytic immune Haemolyses and related conditionsBlood and lymphatic system disorders Y

13 Primary biliary cholangitis 10080429 PT Hepatic fibrosis and cirrhosis Hepatic and hepatobiliary disordersHepatobiliary disorders Y

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How Many Cases of

Autoimmune Diseases?

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Adverse Event (MedDRA v23.0) No. of cases

SOC Blood and lymphatic system disorders

PT Anaemia 5

PT Autoimmune neutropenia 5

PT Evans syndrome 1

PT Platelet anisocytosis 1

PT Platelet toxicity 2

SOC Cardiac disorders

PT Autoimmune myocarditis 4

PT Myocardial infarction 1

PT Myocarditis 2

How Many Cases of

Autoimmune Diseases? (cont)

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Adverse Event (MedDRA v23.0) No. of cases

SOC Endocrine disorders

PT Polyglandular autoimmune syndrome type I 2

PT Thyroid disorder 1

SOC Eye disorders

PT Birdshot chorioretinopathy 2

PT Autoimmune uveitis 3

SOC Hepatobiliary disorders

PT Primary biliary cholangitis 3

PT Hepatitis toxic 1

PT Hepatocellular injury 1

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How Many Cases of

Autoimmune Diseases? (cont)

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Adverse Event (MedDRA v23.0) No. of cases

SOC Immune system disorders

PT Autoimmune disorder 4

SOC Musculoskeletal and connective tissue disorders

PT Arthritis 1

PT Muscular weakness 2

PT Polymyalgia rheumatica 1

PT Rheumatoid arthritis 3

SOC Skin and subcutaneous tissue disorders

PT Alopecia 1

PT Skin haemorrhage 1

PT Vitiligo 2

Secondary SOC Analysis and

Use of a Grouping Term

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Adverse Event (MedDRA v23.0) No. of cases

SOC Immune system disorders

HLGT Autoimmune disorders 30PT Autoimmune disorder 4

PT Autoimmune myocarditis 4

PT Autoimmune neutropenia 5

PT Primary biliary cholangitis 3

PT Birdshot chorioretinopathy 2

PT Evans syndrome 1

PT Polyglandular autoimmune syndrome type I 2

PT Polymyalgia rheumatica 1

PT Rheumatoid arthritis 3

PT Autoimmune uveitis 3

PT Vitiligo 2

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New Standardised MedDRA Query

(SMQ)

Immune-mediated/autoimmune

disorders (SMQ)

• Production release September 2020, Version 23.1

• Aid in identification of potential cases associated with immunotherapeutic agents or vaccines

• Large SMQ with over 500 PTs (narrow and broad)

• SMQ excludes sign/symptom terms (too noisy), post-infection, and hypersensitivity conditions

• See MedDRA Version 23.1 SMQ Introductory Guide for detailed information

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Open Session - Additional QuestionsPlease type any additional questions in the Questions pane

Help Desk Function

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• Online contact form• Direct email• Telephone• Social Media• Instant ‘chat’ function

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MSSO Contacts

• Website

www.meddra.org

• Email

mssohelp@meddra.org

• Frequently Asked Questions

www.meddra.org/faq

• MedDRA Browsers

https://www.meddra.org/meddra-desktop-browsers (Desktop Browser)

https://tools.meddra.org/wbb/ (Web-Based Browser)

https://mmb.meddra.org (Mobile Browser)

MSSO Contacts

• Self-Service Application

https://www.meddra.org/meddra-self-service-application

• Training Schedule

https://www.meddra.org/training/schedule

• Change Request Submission

https://www.meddra.org/how-to-use/change-requests

• MedDRA Support Documentation

https://www.meddra.org/how-to-use/support-documentation

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Survey

• It is live now and will only take a moment of your time

• Your feedback is vital to the MSSO to ensure that we provide you with the support that you and your company needs

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