MSSO Open Session 30 June 2020 - Meddra
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MSSO Open Session 30 June 2020
Agenda
• Future Open Session start time(s)
• FDA Field Alert Report (FAR) and MedDRA
• SMQ Update
• MSSO IT Survey
• Questions submitted by the user community
• Any additional questions from participants
9
Future Open Session start time(s) Anna Zhao-Wong, MD, PhD Deputy Director of the MSSO
Question
• Would future Open Session start time(s)
accommodate global time zones?
11
MSSO Open Session
• First session held on 7 May 2020
• Over 140 connections
• Feedback were positive
• Attendees appreciated the opportunity to “see”
the MSSO staff and interact with them directly
• MSSO will continue to offer the Open Session
• Some users did not or could not attend because
of inconvenient or forbidden start time in their
local time zone
12
MedDRA Global
Footprint
MedDRA has 6,000+ subscribing organizations in 126 countries
13
Current Open Session
Start Time
8:00AM
US EDT
14
Future Open Session
Start Times
Session 2:
9:00AM CEST
Session 1:
11:00AM US EDT
15
What’s New Webinars
Starting v23.1
• Multiple sessions in various time zones
• Multiple languages
Course Date Time Time Zone Language
26 Aug 2020 9:00‐10:00 AM US Eastern English
Daylight Time
27 Aug 2020 1:00 – 2:00PM
27 Aug 2020 8:30‐9:30 AM Central European English
Summer Time
What’s New in Xx Sep 2020 TBD China Standard Chinese
MedDRA 23.1 Time
Xx Sep 2020 TBD Korean Standard Korean
Time
17 Sep 2020 11:30 AM‐12:30 PM Argentina Spanish
Regional Time
16
FDA Field Alert Report (FAR) and MedDRA
and
SMQ Update
Judy Harrison, MD
Chief Medical Officer, MSSO
17New Field Alert Report Form
June 2020
18Product Quality Terms in
MedDRA
• MSSO received questions
from product quality
specialists about new
recommendation
• Help colleagues who may
be unfamiliar with
MedDRA
• MSSO is considering an
informational webinar
19SMQ Update
• Existing SMQs will be updated with COVID-19
related terms in MedDRA Version 23.1
– SMQ Infective pneumonia
– SMQ Opportunistic infections
– SMQ Sepsis
• A dedicated SMQ for COVID-19 is planned to go
into production in v23.1
• New SMQ Immune-mediated/autoimmune
disorders will also go into production in v23.1
20MSSO IT Survey
Brian O’Hare
Terminology Maintenance Manager
21MedDRA Information
Technology Survey
• Obtain feedback on MedDRA software tools and
services
• Survey now open
• Questions on the use of existing tools
• New technologies to consider for existing and future
tools
• Results will be discussed in a Blue Ribbon Panel
• 10 September 2020 – 10:00 – 11:30 U.S. EDT
• Registration now open
22Open Session
Question 1
• Is there a plan to put all of MedDRA into IMDRF? Do
companies need to report in both MedDRA and IMDRF?
000403 24Question 2
• Why are there duplicates at LLT level in the translated
versions of MedDRA?
• When coding in non-English MedDRA, which LLT should be
chosen among the LLTs with the same translation?
25Examples of Duplicated
translations
1
2
2
1. British‐American spellings
2. Synonyms
Lexical variants
26Duplicated translations at the LLT
Level
• Duplicated translations are permitted at and only
at the LLT level for various expressions of the
same concept
oBritish spelled LLT versus American spelled LLT:
Oedema Edema; Haemorrhage Hemorrhage
oLexical variants: Back pain Pain back; Allergic
eczema Eczema allergic
27Which Term to Choose?
1
2
2
For a report “牙龈出血”,
which term to choose?
For a report “过敏性湿疹”,
which term to choose?
28Question 3
• We have received a study coded in Spanish. How can we
use MedDRA to code these AEs?
000403 29000403 30
Web-Based Browser 000403 31
WBB: Hierarchy Analysis Function
• Step 1:
– Import list of coded data in original language in Excel format
– Export results with codes (with hierarchy if required)
• Step 2:
– Re-import the spreadsheet with only the numeric codes (delete
MedDRA terms)
– Change language to desired translation
– Export results in translated language with terms, codes and
hierarchy as required
• Step 3:
– Match up original spreadsheet with second language export using
MedDRA codes
000403 32Web-Based Browser – Hierarchy Analysis
Demonstration
000403 33Question 4
In a case of drug prescribed via unapproved administration route, the
patient calls medical information after reading the leaflet. We
confirm that the route of administration was unapproved but the
patient will take the drug via unapproved administration route.
There is a medication error from the prescriber as the prescription by
unapproved administration route was non‐intentional. However, the
patient intentionally took the medication by the unapproved route of
administration.
Should we code both special situations: medication error (Drug route
prescribing error) and misuse (Intentional use by incorrect route)?
34
000403Question 4
MTS:PTC section 3.16
35Question 4
36Question 5
• If a lack of drug effect is not clearly mentioned can we code
the lack of efficacy?
• For example, if a drug is indicated for sleep disorder and the
AE report form mentioned that the patient is tired at
awakening, can we code lack of efficacy or do we code
tiredness as adverse reaction?
37Question 5
Example:
To better support retrieval of cases of
pregnancies under oral contraception,
code LODE or Medication error in addition
to LLT Pregnancy on oral contraceptive, for
better distinction of the respective
medical background
39Question 5
• If a lack of drug effect is not clearly mentioned can we code
the lack of efficacy?
• For example, if a drug is indicated for sleep disorder and the
AE report form mentioned that the patient is tired at
awakening, can we code lack of efficacy or do we code
tiredness as adverse reaction?
40Question 5
41Question 5
42Question 5
Tiredness may also be caused by
e.g. a prolonged drug effect
Don’t make a diagnosis out of
the reported symptom
Select LLT Tiredness
43Question 6
• When is it acceptable to use product specific
coding conventions e.g. for product use issues,
medication errors, specific known reactions
etc? We have a number of these; some are very
old. How should we evaluate them and maintain
them going forward?
• Not generally recommended
• Advise forming a group to review and update
• Ensure consistency with MTS:PTC and PtC
Companion Document
44Question 7
• How should we handle modification of
underlying conditions, in several circumstances
e.g. clinical trials, following a medication
error/product use issue, or following
interruption or stopping of medication?
• For example: LLT Drug withdrawal syndrome -
should this be captured for all class of drug?
– Therapy with ophthalmic product was interrupted
due to a supply issue and the patient experienced a
worsening in the visual acuity accuracy. Is this the
right LLT or should another one be selected?
45• Modification of
pre-existing
conditions
4647
48
Modification of Conditions
• Code all the events reported
– Therapy cessation, Therapy interruption
– Underdose, Overdose, Misuse, Missed dose etc…
• Do not infer or assume worsening unless
explicitly reported
• Follow any corporate coding conventions,
e.g. relating to disease progression, or where
a pre-existing condition continues unchanged
49Example
Therapy with ophthalmic product was interrupted due
to a supply issue and the patient experienced a
worsening in the visual acuity accuracy
Question: Is Drug withdrawal syndrome the right LLT or
should another one be selected?
• Select LLTs to capture:
– Therapy interruption
– Product supply issue
– Visual acuity decreased
50Drug withdrawal syndrome
A specific medical syndrome,
referring to a cluster of symptoms
in the context of drug dependence
Dorland’s Medical Dictionary
Coding – Must not diagnose
52Question 8
• I’m trying to enter a new Change Request
but when I enter it there is only an option
for translation requests. Why is this?
53WebCR Passwords
MedDRA password:
• Translation updates only
• CR search, view submitted requests available
999999
Change Request ID:
• All MedDRA change request types
• All WebCR functions (e.g., CR search)
54Additional Questions
Please type any additional questions in the Question pane
55Help Desk Function
Contact our Help Desk
• Online contact form
• Direct email
• Telephone
• Social Media
• Instant ‘chat’ function
56MSSO Contacts
Website
• www.meddra.org
Email
• mssohelp@meddra.org
Frequently Asked Questions
• www.meddra.org/faq
59MSSO Contacts (cont)
• 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)
60MSSO Contacts (cont)
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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