Australian Medicines Terminology Editorial Rules
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Australian Medicines Terminology Editorial Rules 30 April 2021 v2.9 Approved for external information Document ID: DH-3447:2021 Australian Digital Health Agency ABN 84 425 496 912, Level 25, 175 Liverpool St, Sydney, NSW 2000 Telephone 1300 901 001 or email [email protected] www.digitalhealth.gov.au Acknowledgements Council of Australian Governments The Australian Digital Health Agency is jointly funded by the Australian Government and all state and territory governments. IHTSDO (SNOMED CT) This material includes SNOMED Clinical TermsTM (SNOMED CT®) which is used by permission of the International Health Terminology Standards Development Organisation (IHTSDO). All rights reserved. SNOMED CT® was originally created by The College of American Pathologists. “SNOMED” and “SNOMED CT” are registered trademarks of the IHTSDO. 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OFFICIAL Australian Medicines Terminology Editorial Rules v2.9 Document information Key information Owner Director, Clinical Terminology and Tooling Date of next review 31 October 2021 Contact for enquiries Australian Digital Health Agency Help Centre Phone 1300 901 001 Email [email protected] Product or document version history Product or Date Release comments document version 2.0 8 July 2014 Update from v2 model to AMT v3. 2.1 21 Oct 2016 This update features the following revisions: • rule changes made as a result of discussion and review by the AMT Support Group; • routine review and clarification to existing rules, in particular updates to those rules pertaining to descriptions for multi-component and multipack products; • implementation of the Agency Clinical Interface Descriptions project work; and • substance name changes related to the TGA International Harmonisation of Ingredient Names project work. Technical information provided in other documents has been removed, along with the majority of examples which can be viewed within the terminology browser. 2.2 30 Nov 2017 This update features updates and additions to: • Sections 4.7 Trade Product Unit of Use (TPUU), 4.8 Trade Product Pack (TPP) and 4.9 Containered Trade Product Pack (CTPP) in relation to products where two different formulations exist with the same Trade Product name. • Section 4.8.2.1, TPP Fully Specified Name definition • Appendix E.1, Continuous semi-solid preparations • Appendix E.2, Dual strength representation • Appendix K.1, Vaccines, has had a major update with new rules applied 2.3 31 May 2018 This update features updates and additions to: • Section 4.6.2 in relation to the strength representation of Trade Products. • 4.6.3.2 TP Fully Specified Names rules examples • Appendix E, Strength formats and Appendix E2.2 for Acceptable synonyms • Appendix G, Form • Appendix J, Container Types • Appendix K.1, Vaccines – examples 30 April 2021 Approved for external information 3 of 130 DH-3447:2021 Australian Digital Health Agency Product or Date Release comments document version 2.4 31 October 2018 This update features updates and additions to: • Substance name changes related to the TGA International Harmonisation of Ingredient Names project work • 4.2.5.2 Combination packs • 6.1 Australian Qualifier definition • Appendix E – General strength formats • Appendix G – Form and Appendix H, Proprietary descriptions and equivalents • Appendix J – Container Types 2.5 30 April 2019 This update features updates and additions to: • 4.6.2 TP details • 4.7.2 TPUU descriptions • 4.8 Trade Product Pack (TPP) • 4.9.2.4 CTPP Preferred Term rules • Appendix B.1 Discernible therapeutic differences to the base (clinically significant modifications) • Appendix G – Form • Appendix E.1 Strength expression rules for specific medication forms • Appendix E.3 Strength expression rules for specific substances • Appendix K.8 Herbal preparations 2.6 31 October 2019 This update features updates and additions to: • 4.2.4 Multi-component • 4.5.2.1 MPP Fully Specified Name definition • 4.5.2.3 MPP Preferred Term definition • 4.7.1.2 Exceptions for products with “inert substance” ingredients • 4.8.2.2.2 TPP Preferred Term brief definition – multi-component TPP • 4.9.2 CTPP descriptions • Appendix E – General strength formats • Appendix G – Form • Appendix J – Container types • Appendix K.8 Herbal preparations 2.7 30 April 2020 This update features updates and additions to: • Appendix E – General strength formats • Appendix F – Units of measure • Appendix J – Container types 2.8 31 October 2020 This update features updates and additions to: • 4.5.2.3 MPP Preferred Term definition • 4.6.2 TP details for specific population • Appendix E – Acceptable synonyms • Appendix F – Units of measure 4 of 130 Approved for external information 30 April 2021 DH-3447:2021 Australian Medicines Terminology Editorial Rules v2.9 Product or Date Release comments document version 2.9 30 April 2021 This update features updates and additions to: • Appendix F – Units of measure • Appendix F – Proportions 30 April 2021 Approved for external information 5 of 130 DH-3447:2021 Australian Digital Health Agency Table of contents 1 Introduction ........................................................................................... 8 Purpose ................................................................................................. 8 Intended audience ................................................................................ 8 Scope ..................................................................................................... 8 Background ........................................................................................... 8 2 Notation ................................................................................................. 9 Extended Backus-Naur Form................................................................. 9 Tables ..................................................................................................10 3 AMT model overview .............................................................................11 Identifiers ............................................................................................11 Descriptions ........................................................................................11 Fully Specified Name ...........................................................11 Synonyms - Preferred Term .................................................12 Synonyms - acceptable synonym(s) ....................................12 Concepts..............................................................................................12 Relationships .......................................................................................12 IS A relationships .................................................................12 HAS A relationships .............................................................12 Reference sets .....................................................................................13 The AMT model ...................................................................................13 4 Product concepts ...................................................................................15 Syntax ..................................................................................................15 Product types ......................................................................................15 Single ingredient ..................................................................16 Multi-ingredient ..................................................................16 Single component ................................................................16 Multi-component ................................................................17 Packs ....................................................................................18 Medicinal Product (MP) ......................................................................19 Medicinal Product definition ...............................................19 MP descriptions ...................................................................21 Medicinal Product Unit of Use (MPUU) ..............................................24 Medicinal Product Unit of Use definition ............................24 MPUU descriptions ..............................................................25 Medicinal Product Pack (MPP) ............................................................30