JIC projects IDMP

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ISO / JIC IDMP Projects

HL7 Project to Provide comments and suggestions on the clinical use of the IDMP terminologies.

• PI 501,
• Sponsoring Work Group: Pharmacy WG
• Contact: Garry Cruickshank (g.cruickshank@ sympatico.ca), coordinate with ISO TS215 WG6 Tim Buxton

IDMP Data Elements and Structures (Substances)

Information from Form4

• ISO Identification: NWIP 11238 IDMP 691: Health Informatics – Identification of Medicinal Products – Data elements and structures to uniquely identify and describe substances and specified substances
• Scope:

  This document will develop data elements, structures and relationships between the data elements required to uniquely define and identify substances and specified substances within medicinal products or used for medicinal purposes, dietary supplements, food and feed additives and cosmetics. The document will further provide references to other standards and external terminological resources as applicable to this standard.

  A supplementary technical report will specify the implementation of this standard including development of content and a reference standard.

• Purpose and justification:

  In the context of the regulation of medicinal products, it is necessary to put in place a mechanism whereby substances and specified substances can be identified uniquely and with certainty in any domain. Such an identification will enable regulatory, pharmacovigilance and healthcare activities, inter alia, to be undertaken with increased efficiency and certainty, thereby contributing to improved protection of public health.

  The scope of substances and specified substances goes beyond medicinal products, as patients also take substances for medicinal purposes and dietary supplements, which need to be uniquely identified. The same applies to food and cosmetics. For purpose of veterinary activities, it is also necessary to uniquley identify substances, to which animals are exposed.

  Substances will be defined by a set of elements necessary for their description and characterisation. Specified substances can include additional elements to further define a given material e.g. based on the physical form, grade, purity, essential processes, or manufacturer.

  Information enabling the identification of substances and specified substances can then be made available as between regulators, and to all other interested stakeholders.

• PI 503,
• Sponsoring Work Group: RCRIM WG, and Pharmacy WG
• Awaiting NWIP ballot TC 215/CEN in parallel, seedocuments,
• July 12-Aug 12 HL7 comments-only ballot - HL7 Unique Ballot Id: ISO_SPL_SUBSTID_R1_O1_2009AUG
• Contact: Garry Cruickshank (g.cruickshank@ sympatico.ca)

IDMP Data Elements and Structures (Dose/Unit/Route)

Information from Form4

• ISO Identification: NWIP 11239 IDMP 692: Health Informatics – Identification of Medicinal Products – Identification of Medicinal Products - Data elements and structures to uniquely identify pharmaceutical dose forms, units of presentation and routes of administration.
• Scope:

  This document will develop data elements, structures and relationships between the data elements required for the exchange of information that uniquely and with certainty identify Pharmaceutical Dose Forms, Units of Presentation and Routes of Administration that are related to medicinal products. The document will further provide references to other standards and external terminological resources as required.

  A supplementary technical report will specify the implementation of this standard including development of content and a reference standard.

• Purpose and justification:

  Currently there are several alternative approaches applied for expressing Pharmaceutical Dose Forms, Routes of Administration and Units of Presentations in medicinal products. Therefore, it is necessary to establish a standard that can be used as an international reference for terms, term definitions and term identifiers. The standard should provide data structures for mapping and translations of terms and definitions taking into consideration the various approaches that are currently being applied.

  This would help to ensure consistency of Pharmaceutical Dose Forms, Routes of Administration and Units of Presentation across the drug regulatory, pharmacovigilance and healthcare environments thus helping the adoption of the new standard without impacting on existing approaches.

  The standard is therefore required to ensuring data consistency and in evaluating and comparing medicinal product-related information across countries, which is of particular importance in the area of drug safety

• PI 504
• Sponsoring Work Group: RCRIM WG, and Pharmacy WG
• Awaiting NWIP ballot TC 215/CEN in parallel, seedocuments
• July 12-Aug 12 HL7 comments-only ballot - HL7 Unique Ballot Id: ISO_SPL_DOSEFORMS_R1_O1_2009AUG
• Contact: Garry Cruickshank (g.cruickshank@ sympatico.ca)

IDMP Data Elements and Structures (UOM)

Information from Form4

• ISO Identification: NWIP 11240 IDMP 693: Health Informatics – Identification of Medicinal Products – Identification of Medicinal Products - Data elements and structures to uniquely identify Units of Measurement.
• Scope:

  This document specifies information structures that can be used to communicate Units of Measurement in the context of medicinal products including data elements for terms and term identifiers from existing code systems and terminologies. This standard applies to medicinal products, pharmacovigilance ICSR reporting, healthcare and other areas as applicable.

  This document will relate to existing relevant and available standards and terminology resources and establish a single standardized subset of unit concepts and codes.

  A supplementary technical report will specify the implementation of this standard including development of content and a reference standard.

• Purpose and justification:

  The target is to unambiguously express Units of Measurement for:

  • Description of quantitative composition of medicinal products and packaging;
  • Any Units of Measurement required for adverse drug reaction reporting in the frame of Individual Case Safety Reports (ICSRs).

  This standard applies to medicinal products, pharmacovigilance ICSR reporting, healthcare and other areas as applicable.

  Currently there are several alternative approaches applied for expressing Units of Measurements. Therefore, it is necessary to establish a standard that can be used as an international reference for terms, term definitions and term identifiers. The standard should provide data structures for mapping and translations, taking into consideration the various approaches currently being applied.

  This would help to ensure consistency of units of measurements across the drug regulatory, pharmacovigilance and healthcare environments thus helping the adoption of the new standard without impacting on Units of Measurements used in existing catalogues. A consistent description of commonly encountered arbitrary units is proposed, e.g. WHO international units for biological activities.

  The purpose is to facilitate unambiguous electronic communication of quantities together with their Units. The focus is on electronic communication, as opposed to communication between humans.

• PI 505
• Sponsoring Work Group: RCRIM WG, and Pharmacy WG
• Awaiting NWIP ballot TC 215/CEN in parallel, seedocuments
• July 12-Aug 12 HL7 comments-only ballot - HL7 Unique Ballot Id: ISO_SPL_UNITSMEASURE_R1_O1_2009AUG
• Contact: Garry Cruickshank (g.cruickshank@ sympatico.ca)

IDMP Data Elements and Structures (MPIDs)

Information from Form4

• ISO Identification: NWIP 11240 IDMP 693: Health Informatics – Identification of Medicinal Products – Identification of Medicinal Products - Data elements and structures to uniquely identify medicinal products (MPIDs) for the exchange of regulated medicinal product information.
• Scope:

  This document will develop data elements, structures and relationships between the data elements required for the exchange of information that uniquely and with certainty identifies a medicinal product. The document will further provide references to other standards and external terminological resources as required.

  A supplementary technical report will specify the implementation of this standard including development of content and a reference standard.

• Purpose and justification:

  In the context of the regulation of medicinal products, it is necessary to put in place a mechanism whereby a medicinal product can be identified uniquely and with certainty in any domain. Such an identification will enable regulatory, pharmacovigilance and healthcare activities, inter alia, to be undertaken with increased efficiency and certainty, thereby contributing to improved protection of public health. The proposed standard will provide a mechanism to enable the management and exchange of information uniquely identifying a medicinal product, regardless of where the medicinal product is developed, manufactured or authorised, to be exchanged between stakeholders. Information enabling the identification of a medicinal product can then be made available as between regulators, and to all other interested stakeholders.

• PI 506
• Sponsoring Work Group: RCRIM WG, and Pharmacy WG
• Awaiting NWIP ballot TC 215/CEN in parallel, seedocuments
• July 12-Aug 12 HL7 comments-only ballot - HL7 Unique Ballot Id: ISO_SPL_MPID_R1_O1_2009AUG
• Contact: Garry Cruickshank (g.cruickshank@ sympatico.ca)

IDMP Data Elements and Structures (PhPIDs)

Information from

Form4

• ISO Identification: NWIP 11240 IDMP 693: Health Informatics – Identification of Medicinal Products – Identification of Medicinal Products - Data elements and structures to uniquely identify and exchange pharmaceutical products (PhPIDs).
• Scope:

  This document will develop data elements, structures and relationships between the data elements required for the exchange of information that uniquely and certainly identifies a pharmaceutical product. The document will further provide references to other standards and external terminological resources as required.

  A supplementary technical report will specify the implementation of this standard including development of content and a reference standard.

• Purpose and justification:

  In the context of the regulation of medicinal products, it is necessary to put in place a mechanism whereby a pharmaceutical product can be identified uniquely and with certainty in any domain. Such an identification will enable regulatory, pharmacovigilance and healthcare activities, inter alia, to be undertaken with increased efficiency and certainty, thereby contributing to improved protection of public health. The proposed standard will provide a mechanism to enable the management and exchange of information to uniquely identifying a pharmaceutical product to be exchanged between stakeholders. Information enabling the identification of pharmaceutical products can then be made available as between regulators, and to all other interested stakeholders.

  A medicinal product can consist of one or several pharmaceutical products, given to (or taken by) a patient with a therapeutic or diagnostic intent. PHPIDs will enable to identify medicinal products, which share the same pharmaceutical product(s).

• PI 502
• Sponsoring Work Group: RCRIM WG, and Pharmacy WG
• Awaiting NWIP ballot TC 215/CEN in parallel, seedocuments
• July 12-Aug 12 HL7 comments-only ballot - HL7 Unique Ballot Id: ISO_SPL_PHPID_R1_O1_2009AUG
• Contact: Garry Cruickshank (g.cruickshank@ sympatico.ca)