Health informatics — Identification of medicinal products (IDMP): Data Elements and Structures 

DESCRIPTION

The HL7/ANSI standards related to the ISO Identification of Medicinal Products (IDMP) have been retired. The “retired” status only applies to the HL7 publication. The ISO IDMP standards are still active and managed by ISO TC 215.

The prior HL7/ANSI approved versions of the ISO IDMP standards were an “extra layer” of approval, the ISO IDMP standards were not altered in the HL7/ANSI approval process. Since HL7/ANSI approval and publication of these standards in 2014, ISO has revised 7 and withdrawn 2 standards in the IDMP family. While considering updating the HL7/ANSI IDMP standards to the ISO IDMP changes, it was noted that the IDMP standards are at a more detailed level than is applicable to the clinical/administrative focus of HL7. As such, it was decided to retire the HL7/ANSI IDMP standards, and to point interested parties to the current ISO IDMP standards.

ISO IDMP standards

as of February 2020.  The linked sites will indicate if there is a newer revision.

ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order 

• ISO/TS 19844:2018 Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances
  • https://www.iso.org/contents/data/standard/07/19/71965.html
  • This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e . what they are) rather than on their use or method of production. ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. 
• ISO/TR 14872:2019 Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms
  • https://www.iso.org/contents/data/standard/06/57/65714.html
  • The purpose of this document is to describe the core principles and proposed service delivery model for supporting implementation and ongoing maintenance of IDMP terminologies. The information provided in this document can be used as evaluation and/or design criteria when considering current or future operations and service level agreements for systems and terminology support services in conformity with IDMP.
• ISO/TS 20443:2017 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
  • https://www.iso.org/contents/data/standard/06/80/68041.html
  • ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
  • Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.
  • Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.
• ISO/TS 20451:2017 Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
  • https://www.iso.org/contents/data/standard/06/80/68086.html
  • ISO/TS 20451:2017 defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
  • Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of ISO/TS 20451:2017.
  • Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of ISO/TS 20451:2017.
• ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
  • https://www.iso.org/contents/data/standard/07/01/70150.html
  • ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.
  • Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable.
  • Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.
• ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
  • https://www.iso.org/contents/data/standard/07/00/70044.html
  • ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient.

ALTERNATIVE NAMES

Health informatics — Identification of medicinal products (IDMP): Data Elements and Structures  may also go by the following names or acronyms:

RELATED DOCUMENTS

Health informatics — Identification of medicinal products (IDMP): Data Elements and Structures

TOPIC

• Pharmacy

BALLOT TYPE

• Normative

STATUS DATE

RESPONSIBLE WORK GROUP

Pharmacy

FAMILY

• V3

CURRENT STATE

• Retired

REALM

• Universal