iso idmp: practical considerations from xevmpd experience
DESCRIPTION
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabulariesTRANSCRIPT
IDMP: Practical considerations from XEVMPD experience
Michiel Stam
Manager Regulatory Operations
Qdossier B.V.
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What is XEVMPD?
(eXtended) Eudravigilance Medicinal Product Dictionary (Database)
Eudravigilance is a central database containing adverse reaction reports to medicines licensed across the EU.
Medicinal Product concerns all approx. 500.000 product licences by any authority following any procedure in EU
Dictionary relational database for unique identification of data structured according to controlled syntaxes and vocabulary
Optional since 2005 as EVMPD
Mandated as XEVMPD since 2nd of July 2012
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XEVMPD information
Authorized products
Pharmaceutical products Pharmaceutical form, Route of administration
Active substances, excipients, adjuvant
SubstancesEnglish name, aliases, translations, reference source name, substance class
ATC codes
Indications (MedDRA codes)
Market authorisation and procedural information
Sponsor/MAH and QPPV information and contacts
PV information
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Drug Safety
Medicines save lives and relieve suffering, but….
Can also cause side effects
5% of all hospital admissions
Nearly 200,000 deaths per year in the EU
Promote and protect public health by Reducing burden of side effects
Optimizing the use of medicines
(X)EVMPD Context
New EU Pharmacovigilance legislation 2012
From Safety assessment towards Risk/benefit analyses
Tool to support improved signal detection
More specifically attribute adverse events to medicines
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Patient benefit/risk ratio
DIA www.diahome.org 6
Building a link between eCTD and XEVMPD - Qdossier B.V.
Marketing License through CTD
PSUR
ICSRsby
E2B
Clinical
studiesNo link yet between ICSRs
and quality of the product
RMP
Literature
XEVMPD / IDMP
Educa-tional program
PhVgSystemMasterFile byGVP
ICSRs
Summary of PSMF
Quality
docu-
ments
Product
infor-
mation
Manu-facturing License through GMP
WW MA
status
RMP Interface
Cover
letter
Appli-cation form
Enve-lope Portal
Patient benefit/risk ratio
XEVMPD reference information
Data elements for medicinal products based on:
Summary of Product Characteristics (SmPC), which serves the purpose of validation of the information provided in the structured data elements *
Medicinal product authorisation information
Pharmacovigilance information
* or Product Information Leaflet (PIL)
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Key for successful signal detection
Consistency across comparable data (format, granularity)
Sufficient details to specifically attribute AEs to a certain batch, manufacturer, substance
Complete and accurate information
Ability to maintain product life cycle
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Practical challenges
Responsibility? PV vs. RA (central vs. local)
Different data across products, regions and disciplines (incl. local and central RA)
Incorrect, incomplete and inconsistent data
Leading to discussions about:Inconsistency between databases
Semantics
Formats and values
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Different vocabularies across disciplines
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Saline
Sodium Chloride
Salt
NaCl
Broader and narrower terms
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Arginine glutamate
Arginine
L-Arginine
Arginine monoglutamate
Personal preferences
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Substance EV
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SUB12639MIG CITRIC ACID
SUB12482MIG CITRIC ACID MONOHYDRATE
Concentration details
Substance listed as Excipient in country A and as Active in country B
Strength expressed 0,5 mg/ml
0.5 mg
2,5 mg/ 5ml
5%
Decimal comma or dot
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Concentration details (2)
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Examples substance concentrations
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Omit decimal “.” dot or “,” comma in IDMP
Limitations in XEVMPD
Concentration details 2-chamber bagsSingle concentration value (or range) can be provided
Concentration of the administered product to be provided
Administered product expressed as electrolytes in SmPC
Electrolytes not present in EMA Substance list
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Inconsistencies RIM versus SmPC
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Conclusions (so far..)
Requirements go beyond “Do we have this information available?”:
Alignment between SmPC and database(s) Which database(s) contain the data?
What is the primary source of information?
Format and granularity used
Accuracy and completeness
Internal preferences
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Data standards
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Standardization or calibration?
Do we have global established standards?
No
Do we have a globally recommended terminology?
No
Can we calibrate or tune towards local or regional standards instead?
Yes
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Leverage from standards; do not copy
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method
Administration and pharmaceutical form
Mix-up of values for Administration route and Pharmaceutical form:
Concentrate for cutaneous injection
Eye drops, powder and solvent for suspension
Solution for intravenous injection vs. intravenous infusion
What if it is for both?
Medicinal form or Dosage formWhat is to be administered
Pharmaceutical formWhat is the content on the shelf
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Sufficient details in XEVMPD?
DIA www.diahome.org 24
= XEVMPD
= SSI (XEVMPD)= IDMP only
Significant details missing..
Manufacture and batch information
Shelf-life and storage conditions
Clinical particulars, population specifics and contra-indications
Medical device information
Should distinguish between (ISO IDMP 11615 & 11616)Medicinal Product (taken by patient)
Pharmaceutical Product (on the shelf)
Authorised vs.
Marketed products
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Lessons Learned
Inconsistencies across products and countries become visible
Inconsistencies across systems and SmPCs become visible
Gaps and inconsistencies due to decentralised approach (shared responsibilities)
Same contents, different format leads to multiple records
Definition of metadata elements and values must be implemented within all disciples to achieve consistent records (e.g. substance list versus SmPC)
Always consider what is the primary data source
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Thank you !
Michiel Stam
Manager Regulatory Operations
www.qdossier.com