ISO IDMP: Practical considerations from XEVMPD experience
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The document outlines the Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) which serves as a central database for adverse reaction reports in the EU. It discusses the importance of data consistency, accuracy, and the challenges faced in pharmacovigilance due to discrepancies in data across products and regions. Key conclusions emphasize the necessity for alignment between databases and standardized terminology to improve the effectiveness of signal detection in drug safety.
ISO IDMP: Practical considerations from XEVMPD experience
- 1. IDMP: Practical considerations from XEVMPD experience Michiel Stam Manager Regulatory Operations Qdossier B.V.
- 2. 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 12/5/2013 Copyright Qdossier B.V. 2
- 3. XEVMPD information Authorized products Pharmaceutical products Pharmaceutical form, Route of administration Active substances, excipients, adjuvant Substances English 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 12/5/2013 Copyright Qdossier B.V. 3
- 4. 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 12/5/2013 Copyright Qdossier B.V. 4
- 5. (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 12/5/2013 Copyright Qdossier B.V. 5
- 6. Patient benefit/risk ratio Patient benefit/risk ratio PhVg System Master File by GVP RMP Interface ICSRs by E2B ICSRs Manufacturing License through DIA GMP 12/5/2013 WW MA status www.diahome.org Marketing License through CTD Building a link between eCTD and XEVMPD - Qdossier B.V. Copyright Qdossier B.V. 6 6
- 7. 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) 12/5/2013 Copyright Qdossier B.V. 7
- 8. 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 12/5/2013 Copyright Qdossier B.V. 8
- 9. 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 12/5/2013 Copyright Qdossier B.V. 9
- 10. Different vocabularies across disciplines Saline NaCl Sodium Chloride Salt 12/5/2013 Copyright Qdossier B.V. 10
- 11. Broader and narrower terms L-Arginine Arginine glutamate Arginine Arginine monoglutamate 12/5/2013 Copyright Qdossier B.V. 11
- 13. Substance EV SUB12639MIG CITRIC ACID SUB12482MIG CITRIC ACID MONOHYDRATE 12/5/2013 Copyright Qdossier B.V. 13
- 14. 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 12/5/2013 Copyright Qdossier B.V. 14
- 15. Concentration details (2) 12/5/2013 Copyright Qdossier B.V. 15
- 16. Examples substance concentrations Omit decimal “.” dot or “,” comma in IDMP 12/5/2013 Copyright Qdossier B.V. 16
- 17. Limitations in XEVMPD Concentration details 2-chamber bags Single 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 12/5/2013 Copyright Qdossier B.V. 17
- 18. Inconsistencies RIM versus SmPC 12/5/2013 Copyright Qdossier B.V. 18
- 19. 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 12/5/2013 Copyright Qdossier B.V. 19
- 20. Data standards 12/5/2013 Copyright Qdossier B.V. 20
- 21. 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 12/5/2013 Copyright Qdossier B.V. 21
- 22. Leverage from standards; do not copy method 12/5/2013 Copyright Qdossier B.V. 22
- 23. 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 form What is to be administered Pharmaceutical form What is the content on the shelf 12/5/2013 Copyright Qdossier B.V. 23
- 24. Sufficient details in XEVMPD? = XEVMPD = SSI (XEVMPD) = DIA IDMP only 12/5/2013 www.diahome.org Copyright Qdossier B.V. 24 24
- 25. Significant details missing.. Manufacture and batch information Shelf-life and storage conditions Clinical particulars, population specifics and contraindications Medical device information Should distinguish between (ISO IDMP 11615 & 11616) Medicinal Product (taken by patient) Pharmaceutical Product (on the shelf) Authorised vs. Marketed products 12/5/2013 Copyright Qdossier B.V. 25
- 26. 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 12/5/2013 Copyright Qdossier B.V. 26
- 27. Thank you ! Michiel Stam Manager Regulatory Operations www.qdossier.com