This blog covers:
- What IDMP is?
- Why IDMP is important?
- The rules and standards of IDMP.
Table of Contents:
- Exploring Identifications
- Standardization’s Overview
- Advantages of Combining ICSR and IDMP
- Thoughts
- References
Introduction
IDMP – Identification of the Medicinal Product
IDMP is a new addition in the latest updates to E2b, known as E2B(R3). The improvements were discussed in 2005. This element plays a crucial role in identifying medicinal products associated with adverse events.
This method of identification enhances accuracy in analysis and contributes to better quality and communication globally.
Overview
In cooperation with ICH, ISO has formulated a series of standards aimed at improving the exchange of information concerning medicinal products.
One notable guideline is the Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data Elements and Message Specification (E2B(R3) IG).
Within E2B(R3) messages, ISO IDMP standards are recommended for utilization, particularly when referring to global controlled vocabularies and global IDs for ISO IDMP.
Exploring Identifications
Through the IDMP data element, numerous details about medicinal products can be identified across various categories.
The following ten categories primarily focus on medicinal products. These aspects are crucial for capturing detailed dosage information.
Drug information
- Characterisation of Drug Role
- MPID (Medicinal Product Identifier) and PhPID (Pharmaceutical Product Identifier) versions complete details
- Authorisation / Application Number (Holder and Authorisation / Application Number of Drug)
- Dosage and Relevant Information (repeat as necessary)
- Cumulative Dose to First Reaction (number and Unit)
- Indication for Use in Case (repeat as necessary)
- Drug-reaction(s) / Event(s) Matrix (repeat as necessary)
- Additional Information on Drug (repeat as necessary)
- Gestation Period at Time of Exposure (number/Unit)
- Action(s) Taken with Drug
- Drug-reaction(s) / Event(s) Matrix (repeat as necessary)
“International standards are the silent architects of a connected world, fostering collaboration, innovation, and progress across borders. They provide a universal language for excellence, ensuring that ideas, products, and systems meet the highest benchmarks of quality, safety, and efficiency on a global scale.”
Standardization’s Overview
ISO ICSR Standards:
Presenting Two Draft International Standards:
- ISO/DIS 27953-1: Health Informatics – Pharmacovigilance – Individual Case Safety Report – Part 1: Framework for Adverse Event Reporting
- ISO/DIS 27953-2: Health Informatics – Pharmacovigilance – Individual Case Safety Report – Part 2: Reporting Requirements for Human Pharmaceutical ICSR.
ISO IDMP Standards:
IDMP, an ISO standard, mandates the provision of the Medicinal Product Identifier (MPID) or Pharmaceutical Product Identifier (PhPID) based on the reported product name. If unavailable, leave these elements blank.
In collaboration with the ICH M5 EWG, ISO developed a set of standards to enhance exchange of information for medicinal products.
Key ISO IDMP standards comprise:
- ISO 11238: Health Informatics – Identification of Medicinal Products – Data Elements and Structures for Unique Identification and Exchange of Regulated Information on Substances
- ISO 11239: Health Informatics – Identification of Medicinal Products – Data Elements and Structures for Unique Identification and Exchange of Regulated Information on Pharmaceutical Dose Forms, Units of Presentation, Routes of Administration, and Packaging
- ISO 11240: Health Informatics – Identification of Medicinal Products – Data Elements and Structures for Unique Identification and Exchange of Units of Measurement
- ISO 11615: Health Informatics – Identification of Medicinal Products – Data Elements and Structures for Unique Identification and Exchange of Regulated Medicinal Product Information
- ISO 11616: Health Informatics – Identification of Medicinal Products – Data Elements and Structures for Unique Identification and Exchange of Regulated Pharmaceutical Product Information.
Advantages of Combining ICSR and IDMP
- Including MPID in ICSR ensures clear definition of the involved product.
- MPIDs are directly linked to PhPIDs for clarity.
- Enhances the value of pharmacovigilance reports shared across regions.
- Promotes clear and understandable data.
- Standardizes the identification of medicinal products.
Wrap up
Feel free to share your insights and thoughts on the significance of integrating IDMP within pharmacovigilance, as discussed in this awareness blog.
The seamless integration with E2B(R3) transmission is a crucial aspect to monitor, and we eagerly anticipate updates in the fourth revision of E2B transmission.
Leave your comments below to engage in a meaningful discussion on this informative piece.
Abbreviations:
- MPID: Medicinal Product Identifier
- PhPID: Pharmaceutical Product Identifier
- UCUM: Unified Code for Units of Measure
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