HM Medical Clinic

Draft hkctt editorial policy

Editorial Guide on Hong Kong Clinical
Terminology Table –
Drugs (Medication Terminology Table)
[Document Reference No. G52]
Version 1.1
January 2015
The Government of the Hong Kong Special Administrative Region Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Intellectual Property Rights Notice
2015 by the Government of the Hong Kong Special Administrative Region
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Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Document Summary
Document Item
Current Value
– Drugs (Medication Terminology Table) Date Last Modified Current Document Issue This document describes the editorial principles Document Description and rules regarding the content of medication terminologies. eHR Information Standards Office Contact Information Amendment History
Version No.
Summary of Changes
Original version Chapter 6.12 Multi-ingredient products with combined strength expression – added exception rules to allow combined strength expression for certain antimicrobial agents Chapter 6.13 Multi-component Products : updated expression rules on multiple-component products Updated product description rules to allow use of drug names enlisted in the Poisons List as preferred description where applicable. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 1.1.1 In July 2007, the Steering Committee on eHR Sharing was established to develop the electronic health record (eHR). The HKCTT has been being built to support the interoperability of eHR. In fact, standard terminology is the foundation for supporting the development of an interoperable electronic health record (eHR) and it ensures the shared health data can be accurately interpreted, and thus can be reused to improve care delivery and optimize workflow. Standard terminology also supports disease surveillance to improve population health; generates medical knowledge to facilitate decision support and health services planning. 1.1.2 Hong Kong Medication Terminology table (HKMTT) is part of the HKCTT, and is required for support of the management of medication information because inconsistent or incomplete information not only results in inefficiency and unnecessary expense, but can also have an adverse impact on clinical care. WHAT IS HONG KONG MEDICATION TERMINOLOGY 1.2.1 HKMTT is a compilation of identifying descriptions with coding of individual drugs registered under the Pharmacy and Poison Board, which contains information of pharmaceutical product and their components including dosage form and strength. 1.2.2 The specifications of HKMTT are as follows: robust and sustainable; data should support recording of prescription and dispensing from healthcare sector; The schema should be in the form of a logical and navigable hierarchies, allowing the submission of drug data at various levels of granularity; The core HKMTT tables are supported by supporting information tables (i.e. the Qualifier tables, see later notes) that must also be constructed in the same manner; The HKMTT table should be designed in such a way that it is interoperable with other international standards (i.e. SNOMED-CT, Australian NEHTA AMT) (what do you mean?) HKMTT DEVELOPMENT PROCESS [1][2][3][4] 1.3.1 The entire developmental approach has taken reference on previous works by the following organizations:  SNOMED CT User Guide (Current Version), International Health Terminology Standard Development Organization (IHTSDO); Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Compendium of Pharmaceutical Products, the Department of Health, HKSAR Government; The design of the data model has taken reference with modifications on the UK Dictionary of Medicines and Devices (dm+d) developed by the UK NHS Connecting for Health, Australian Medicines terminology developed by Australian National E-Health Transition Authority (nehta) 1.3.2 The HKMTT was developed and has undergone review and refinements by the eHR Information Standard Domain Group for Drug Records, with modifications in response to feedback from and consultation with members of the group, comprising of representatives from the Department of Health HKSAR, public hospitals, private hospitals, professional bodies and the eHealth Record Office. 1.3.3 The development of product and qualifier concepts in shall include the following 4-phase approach:-  Phase 1: the initial concept model design, formal definition of data set and the co-production of standardized essential data elements between the Department of Health and eHealth Record Office; Phase 2: preparation, verification and import of essential data of registered pharmaceutical product by the Department of Health and its processing by the eHealth Record Office; Phase 3: mapping of the initial standardization data to SNOMED-CT; Phase 4: Technical development of the DH-CPP to MTT Co-Production Interface and the eHR Information Architecture Management System PURPOSE OF THIS DOCUMENT
This document is developed by the eHealth Record Office HKSAR Government,
to describe the scope, use, technical structures, governance, and maintenance of
developing the HKMTT. This document specifies the Editorial Rules for MTT
which focuses on the naming conventions and specific representation rules
associated with all concept description types in the HKMTT data model and the
related auxiliary qualifier concepts.
GOVERANCE OF HKMTT 1.5.1 eHR Information Standard Coordinating Group (eHR IS CG) The eHR IS CG prioritizes the development of health information standards, and has the following functions:  Approve standards & subsequent updates as recommended by domain groups Initiate & coordinate activities required for the standards lifecycle, e.g. Need of standards for a particular domain area Establishment of domain groups Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Harmonize different standards Represent HKSAR in liaison with standards development organizations on areas relating to health information standards as appropriate 1.5.2 eHR Information Standard Domain Group on Drug Record (eHR IS DG on Drug Record) The eHR IS DG on Drug Record is accountable to the eHR IS CG. It is responsible for:  To develop information standards on drug record to facilitates the sharing of drug data to the eHR To develop and refine the standard dataset for drug orders / dispensing transactions To define & refine the standards on adverse drug reaction records, including the appropriate standard terminology sets To define the scope of drug terminology table To define requirements of the standard drug terminology To develop and refine standard drug terminology with reference to international terminology To provide oversight for management of the drug terminology To develop, endorse and maintain the editorial policy for drug terminology table To identify implementation issues and propose solutions To report to eHR IS CG 1.5.3 HKMTT Content Governance Committee The HKMTT Content Governance Committee defines the Editorial Policies / rules to ensure accurate and consistent building up and maintenance of medication terminology table to support its usage in eHealth Record contents. It is responsible for introducing and the implementation of any editorial changes with resultant changes in schema or table structure, to meet ongoing new requirements in MTT data maintenance; to identify issues and propose solutions to the eHR IS DG on Drug Record. ACKNOWLEDGEMENTS 1.6.1 The eHealth Record Office would like to acknowledge the continuing contributions and support by the following organizations:  Chairman and Members of the eHR Information Standard Domain Group (Drug Record) The Department of Health, HKSAR Government 1.6.2 Special thanks for the Department of Health Drug Office and representatives of the following three pharmaceutical industry associations (names in alphabetic Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) order) in November 2010, for their gracious support in providing information update to drug database, which were very much appreciated:  Hong Kong Association of the Pharmaceutical Industry Hong Kong Pharmaceutical Manufacturers Association Limited The Pharmaceutical Distributors Association of Hong Kong Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) HKMTT MODEL
THE HONG KONG MEDICATION TERMINOLOGY TABLE (HKMTT) 2.1.1 The HKMTT has 8 core concept tables, namely the: Virtual Therapeutic Moiety (VTM) Routed Virtual Therapeutic Moiety (VTM+Route) Virtual Therapeutic Moiety Routed Dose Form (VTM+Route+Form) Virtual Medicinal Product (VMP) Trade Names (TradeName) Routed Trade Name (TradeName+Route) Trade Name Routed Dose Form (TradeName+Route+Form) Actual Medicinal Product (AMP) 2.1.2 These concepts are illustrated in the diagram below: Medication Terminology TableModel (HK product concepts) Has active
ingredient
virtual medicinal actual medicinal Figure 1 – The HKMTT Concept Model

2.1.3 Each of these entries represents a concept level that carries with its distinct set of information. In addition to these 8 concept tables, the core MTT is supported by a series of Qualifier and Substance Concept Tables, which carry structured information as building blocks for MTT concepts. 2.1.4 The MTT allocates unique identifiers (ConceptIDs) for each entry of the 8 core concepts mentioned above, as well as the supporting qualifiers and substances Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) concepts. These are stored at the Hong Kong eHR's local namespace and cross-mapped to SNOMED-CT. 2.1.5 Some major principles: ConceptID never changes – only its contents may be updated; this will secure interoperability through it unique conceptID; Concepts are represented by a unique human-readable term (i.e. the Fully Specified Names, FSN); Concept's specificity is dependent on the amount of details it represents – and the more details a particular concept carries, the more "granular" it is said to be; Multiple levels of granularity enables coding of drug data at the appropriate levels of details that is relevant to clinical practice; Each concept level is designed and maintained for clinical relevancy; Each concept must have defined relationships with other concepts, creating a structured, well-defined hierarchy of drug-product concepts; Concepts may carry a set of other information that is relevant to that particular concept type; The MTT core concept hierarchy would allow machine-readable query and communications between drug systems of participant institutions, hence achieving interoperability. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) THE QUALIFIERS AND SUBSTANCE CONCEPT TABLES 2.2.1 In addition to the 8 core MTT concepts as specified above, there requires a comprehensive series of supporting qualifiers and substance tables, to allow "look-up" of structurally coded concepts be referenced within the core concept tables for various purposes. 2.2.2 Some major principles: All concepts within these qualifier or substance concept tables would be coded into unique identifiers; and within each respective concept tables, the concepts should not be tired to hierarchic position or other contexts; The unique codes should not be reused after a particular term has retired, become obsolete or is being superseded by another concept; All updates and modifications to these concept tables should be subjected to version control; At initial stage of the eHR project, cross-referencing with SNOMED-CT may not be necessary, but these tables should be designed and developed in such a way that it allows for modification and interfacing with SNOMED-CT. Referral to section 5 for requirements and rules on various qualifier and substance concept tables; Referring to the Appendices for qualifier concepts currently included. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) THE HKMTT COMPONENTS
HKMTT MODEL COMPONENTS In the context of this document, a product "concept" is a clinical meaning identified by a unique numeric identifier (ConceptID) that remains unchanged once created. Each concept is represented by a unique human-readable Fully Specified Name (FSN) and a Preferred Term (PT). The concepts are formally defined in terms of their relationships with other concepts. These "logical definitions" give explicit meaning which a computer can process and build query upon. Every concept also has its own set of other human-readable terms. 3.1.2 HKMTT Concepts The HKMTT includes the following concept types: 3.1.2.1 Product Concepts These concepts are used to identify products, including both proprietary and non-proprietary (generic) representations at various levels of granularity. These concepts form the two arms of the HKMTT, with relationships defined between their corresponding trade-generic concepts. Refer to Section 4.1 to 4.9 for full details of the concepts representation and population methods. 3.1.2.2 Substance Concepts These concepts represent the active ingredient(s) within a pharmaceutical product. Refer to Section 5.1 for details of the concepts representation and population methods. 3.1.2.3 Qualifier Concepts These are concepts used to represent the structural element data used to construct various part of product concepts. For instance, "Dose form" concepts are representations of pharmaceutical forms of a drug product; whereas "route" defines the list of route of administration concepts that a pharmaceutical product is approved for. Qualifier concepts also include other atomic data used to construct product concepts, such as qualifier concepts. Refer to Section 5.2 to 5.14 for details of the concepts representation and population methods. 3.1.2.4 HKMTT Relationship (Linkage) Concepts These are concepts defined to represent the relationships between concepts – e.g. these can be IS_A relationship between product concepts, or Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) has_active_ingredient relationship between a generic drug and a substance concept. i. Relationships The HKMTT will use SNOMED CT relationships, which link concepts within SNOMED CT, where the linkage concept is available. HKMTT concepts are linked via such linkage (or relationship) concepts as defined in section 5.14 "Linkage Concept: MTT Relationships". Each of the main eight level concept has at least one IS_A relationship to a supertype concept. IS_A relationship and defining attribute relationships are known as the "defining characteristics" of SNOMED CT concepts. They are considered defining because they are used to logically represent a concept by establishing its relationships with other concepts. This is accomplished by establishing IS_A relationships with one or more defining concepts and modeling the difference with those supertype concepts through defining attributes. ii. HKMTT relationships (Linkage) The HKMTT will include the following relationships to:  Define a relationship between concepts Add attributable information to a concept The HKMTT Relationship types include Has_active_ingredient Has_allergen_group Has_manufacturer Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Is_trade_equiv_of VTM Is_trade_equiv_of VTM+route Is_trade_equiv_of VTM+Route+Form Is_trade_equiv_of VMP 3.2.1 The HKMTT has a defined way to represent concept descriptions. A single concept may also be associated with multiple descriptions, similar to SNOMED CT concept descriptions that a HKMTT concept descriptions include a Fully Specified Names (FSN), a Preferred Term (PT) and an Alias name. 3.2.2 The HKMTT also has additional description types that allow more information of a particular drug product to be added to a concept, represented using relationships or attributes, from an qualifier concept to an HKMTT product concept. 3.2.3 HKMTT Description types All HKMTT concepts will have the following descriptions (as per SNOMED CT):  Fully Specified Name (FSN) Preferred Term (PT) In MTT these descriptions are to be constructed using the core and Qualifier concepts. Varying combination of such concepts will be utilized to make up the constituents of each concept, depending on the level of granularity. Refer to the following sections for full details on the representations and populating of these concepts: Virtual Therapeutic Moiety (VTM) Routed Virtual Therapeutic Moiety (VTM+Route) Form See section 4.4 (VTM+Route+Form) Virtual Medicinal Product (VMP) Trade Names (TradeName) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Routed Trade Name (TradeName+Route) Routed Trade Name Dose Form (TradeName+Route+Form) Actual Medicinal Product (AMP) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) THE HKMTT COMPONENTS
The HKMTT has conceptually been designed to encompass eight distinct "product"
concepts, each containing a set of attributes, and each involves in a defined
relationships (or associations, in technical point of view) with concepts (see section
5.14 for more information on MTT relationships). As described in section 3, the 8
levels product concepts are:

Virtual Therapeutic Moiety (VTM) Routed Virtual Therapeutic Moiety (VTM+Route) Virtual Therapeutic Moiety Routed Dose Form (VTM+Route+Form) Virtual Medicinal Product (VMP) Trade Names (TradeName) Routed Trade Name (TradeName+Route) Trade Name Routed Dose Form (TradeName+Route+Form) Actual Medicinal Product (AMP) PRODUCT TYPES Pharmaceutical products included in the initial set of HKMTT is defined as all medicinal preparations that is regulated and registered by the Department of Health, HKSAR Government, under the regulation of the Pharmacy and Poisons Ordinance (Cap. 138). These preparations will carry a defined set of attributes that confers varying level of granularities, including the following critical data:  HK Registration number Proposed trade name Route of administration Multiple component grouping information Ingredient substance(s) and their corresponding strength per unit of measure PRLS Certificate holder Manufacturer and address PRLS Legal classification The above data elements will be input into the concept table, via which the varying combination of these concepts will be used to create the 8-level concepts of different granularities. 4.1.1 Single ingredient products Single ingredient products refer to pharmaceutical products which contains only one active ingredient per each ingredient unit of measure. Examples (FSNs) of single ingredient products:  VMP: atentolol oral tablet 100 mg Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) AMP: Tenormin (atenolol) oral tablet 100 mg 4.1.2 Multi-ingredient products A multi-ingredient product contains two or more active ingredients compounded in a single unit of measure and cannot be separated. Examples (FSNs) of multi-ingredient products:  VTM: atenolol + chlorthalidone VMP: atenolol 100 mg + chlorthalidone 25 mg oral tablet AMP: Tenoretic (atenolol 100 mg + chlorthalidone 25 mg) oral tablet Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) VIRTUAL THERAPEUTIC MOIETY (VTM) 4.2.1 Virtual Therapeutic Moiety Definition A Virtual Therapeutic Moiety (VTM) is the abstract representation of the active ingredient(s) or substance(s), which when formulated as a single medicinal product, and is intended for use in the treatment or prevent disease in human. Virtual Therapeutic Moiety (VTM) is the abstract conceptual representation of the material defining the prescriber's therapeutic intent, without taking into the account of more product specific information such as the dose formulation, route of administration and strength. For example:  Multi-ingredient drugs (e.g.) would be populated by including all individual active ingredients. The full name of an ingredient (including its salt where clinical relevant or significant) will be used in all cases. The description of the multi-ingredient drug and the order by which they are expressed would be decided by the MTT editorial team on case-by-case basis. The Virtual Therapeutic Moiety name will derive from information on the contained active ingredient concepts, with the following knowledge or rules incorporated:  The precise active ingredient (with salt) will be specified, where this is clinical significant or relevant, unless otherwise specified as exception; The virtual therapeutic moiety defines a group of products, which contain ingredient substances with the same active entity. All virtual therapeutic moiety will have a "has_active_ingredient" relationship with their active ingredient 4.2.1.5 Associations Ascending association:
No ascending association
ii. Descending association:
Routed Virtual Therapeutic Moiety (VTM+Route) IS_A Virtual
Therapeutic Moiety (VTM)
(A single VTM may be associated with one or multiple entities of
VTM+Route)
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table)
iii. Attributable association:
Virtual Therapeutic Moiety (VTM) Has active ingredient
substance
Virtual Therapeutic Moiety (VTM) Is_equiv_to_SCT SNOMED
CT identifier (product)
Attributes
Attribute
Properties
Virtual Therapeutic Moiety (VTM) conceptID SNOMED CT ConceptID SNOMED CT Identifier Virtual Therapeutic Moiety (VTM) Fully String Virtual Therapeutic Moiety (VTM) preferred string Virtual Therapeutic Moiety (VTM) Alias String (multiple entries) Ingredient (multiple entries) MTT identifier : substance (multiple entries)
Ingredient substance PT from substance
Ingredient description concept (multiple entries) Allergy check flag [Y/N] MTT concept stage Last update date Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 4.2.2 Virtual Therapeutic Moiety Descriptions 4.2.2.1 Virtual Therapeutic Moiety "Fully Specified Name" Definition The Fully Specified Name of a Virtual Therapeutic Moiety follows the syntax: VTM FSN = "Ingredient_details" The components are described as: Ingredient_details is the alphabetical list of active ingredient's preferred term. For multi-ingredient products, the VTM should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VTM's FSN (see VTM-FSN-7). 4.2.2.2 Virtual Therapeutic Moiety "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in Appendix apply. The Virtual Therapeutic Moiety name will be derived from the International Non-proprietary Names (INN), followed by other approved or clinically intuitive names. In cases where the drug name enlisted in the Poisons List Regulations (Cap 138B) differs from the recommended INN, the name used in the Poisons List Regulations would be the preferred description. The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case The Virtual Medicinal Product Name will include all active ingredients for each multi-ingredient preparation or component of a multi-component product. The Virtual Medicinal Product name will include all "inert substance" where inactive/inert ingredients are part of the multi-component products or diluents provided for the preparation of the actual administrable form of a product. The identification of all active ingredients is available from the Virtual Medicinal Product (VTM) "has_active_ingredient" relationship with Ingredient (substance). Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.2.2.3 Virtual Therapeutic Moiety "Preferred Term" Definitions The Preferred Term of a Virtual Therapeutic Moiety follows the syntax: VTM PT = "Ingredient_details" The components are described as: Ingredient_details is the alphabetical list of active ingredient's preferred term. For multi-ingredient products, the VTM should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VTM's FSN (see VTM-PT-7). 4.2.2.4 Virtual Therapeutic Moiety "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in apply. The Virtual Medicinal Product preferred term will be derived from the International Non-proprietary Names (INN), followed by other approved or clinically intuitive names. In cases where the drug name enlisted in the Poisons List Regulations (Cap 138B) differs from the recommended INN, the name used in the Poisons List Regulations would be the preferred description. The Virtual Medicinal Product Preferred Term will include up to three active ingredients per product; for Virtual Medicinal Products with more than three active ingredients, the MTT editorial team would attempt to create a clinically intuitive description on an individual basis, with an exception: The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) The Virtual Medicinal Product Name will include all active ingredients for each multi-ingredient preparation or component of a multi-component product. The Virtual Medicinal Product name will include all "inert substance" where inactive/inert ingredients are part of the multi-component products or diluents provided for the preparation of the actual administrable form of a product. The identification of all active ingredients is available from the Virtual Medicinal Product (VTM) "has_active_ingredient" relationship with Ingredient (substance). The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.2.2.5 Virtual Therapeutic Moiety "Alias Name" Rules Description
All rules in "Alias name definition and Rules" apply Capitalisation rules as defined in Appendix apply. The entry of Alias names would be optional and only be populated when it is clinically relevant; it should be constructed in the way that it does not impact the product being safely identified. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) ROUTED VIRTUAL THERAPEUTIC MOIETY (VTM + ROUTE) 4.3.1 Routed Virtual Therapeutic Moiety Definition A Routed Virtual Therapeutic Moiety (VTM+Route) is the abstract concept representing the administrable route of administration form for a given virtual therapeutic moiety. An entry of VTM may be associated with zero to many entries of VTM+route concepts 4.3.1.2 Associations Ascending association:

Routed Virtual Therapeutic Moiety (VTM+Route) IS_A Virtual
Therapeutic Moiety (VTM)

ii. Descending association:
Virtual Therapeutic Moiety Routed Dose Form (VTM+Route+Form)
IS_A Routed Virtual Therapeutic Moiety (VTM+Route)

iii. Attributable association:
Routed Virtual Therapeutic Moiety (VTM+Route) Has route route
of administration
Therapeutic (VTM+Route) Is_equiv_to_SCT SNOMED CT identifier (product)
Attributes
Attribute
Properties
Moiety MTT identifier (VTM+Route) conceptID SNOMED CT ConceptID SNOMED CT Identifier Routed Virtual Therapeutic Moiety Fully String Routed Virtual Therapeutic Moiety Preferred String Virtual Therapeutic Moiety (VTM) preferred Copy VTM preferred term from AMP Virtual Therapeutic Moiety (VTM) shortname Copy VTM shortname from AMP Copy VTM aliasname from AMP (multiple Virtual Therapeutic Moiety (VTM) Alias name MTT Identifier : Route
Route description Route preferred term from Route concept
Ingredient (multiple entries) MTT identifier : substance (multiple entries)
Ingredient substance PT from substance concept
Ingredient description (multiple entries) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Allergy check flag [Y/N] MTT concept stage Last update date 4.3.2 Routed Virtual Therapeutic Moiety Descriptions 4.3.2.1 Routed Virtual Therapeutic Moiety "Fully Specified Name" Definition The Fully Specified Name of a Routed Virtual Therapeutic Moiety follows the syntax: i. Single ingredient VTM+R: VTM+R FSN = "Ingredient_details" + "route" ii. Multi-ingredient VMP: VTM+R FSN = "Ingredient_details" + "Ingredient_strength" + "ingredient_details_2" + "ingredient strength" + "route" The components are described as: Ingredient_details is the alphabetical list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). 4.3.2.2 Routed Virtual Therapeutic Moiety "Fully Specified Name" Description
All rules in "Fully Specified Name definition and Rules" apply Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Capitalisation rules as defined in Appendix apply. MTT- VTMR -FSN-2
The Routed Virtual Therapeutic Moiety name will be derived from the base or salt of the active ingredients, as defined in VTM FSN and PT. MTT- VTMR -FSN-3
The Routed Virtual Therapeutic Moiety name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case MTT- VTMR -FSN-4
Route The route of administration will include information on how the product should be used, as specified in the product's insert. MTT- VTMR -FSN-5
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.3.2.3 Routed Virtual Therapeutic Moiety "Preferred Term" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Specified Name of a Routed Virtual Therapeutic Moiety follows the syntax: i. Single ingredient VMP: VTM+R PT = "Ingredient_details" + "route" ii. Multi-ingredient VMP: VTM+R PT = "Ingredient_details_1" + "ingredient_details_2" + "route" The components are described as: Description
Definition
Component
Ingredient_Details
Ingredient_details is the alphabetical list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). 4.3.2.4 Routed Virtual Therapeutic Moiety "Preferred Term" Rules Description
MTT- VTMR -PT-1
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix A apply. MTT- VTMR -PT-2
The Routed Virtual Therapeutic Moiety preferred term will be derived from the base or salt of the active ingredients, as defined in VTM PT. MTT- VTMR -PT-3
The Routed Virtual Therapeutic Moiety preferred term will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case MTT- VTMR -PT-4
Route: The route of administration will include information on how the product should be used, as specified in the product's insert. MTT- VTMR -PT-5
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) VIRTUAL THERAPEUTIC MOIETY ROUTED DOSE FORM (VTM + ROUTE + FORM) 4.4.1 Virtual Therapeutic Moiety Route Dose Form Definition A Virtual Therapeutic Moiety Routed Dose Form (VTM+Route+Form) is the abstract concept representing the available dose form for a given virtual therapeutic moiety that is intended to be given via a route as specified. 4.4.1.2 Assocications Ascending association:

Virtual Therapeutic Moiety Routed Dose Form (VTM+Route+Form)
IS_A Routed Virtual Therapeutic Moiety (VTM+Route)

ii. Descending association:
Virtual Medicinal Product (VMP) IS_A Virtual Therapeutic
Moiety Routed Dose Form (VTM+Route+Form)
iii. Attributable association:
Virtual Therapeutic Moiety Routed Dose Form (VTM+Route+Form)
Is_equiv_to_SCT SNOMED CT identifier
Virtual Therapeutic Moiety Routed Dose Form (VTM+Route+Form)
Has dose form dose form
Attributes
Attribute
Properties
Virtual Therapeutic Moiety (VTM) Routed Dose MTT identifier SNOMED CT ConceptID SNOMED CT Identifier Virtual Therapeutic Moiety Routed Dose Form String Fully Specified Name Virtual Therapeutic Moiety Routed Dose Form String Virtual Therapeutic Moiety (VTM) preferred term Copy VTM preferred term from AMP Copy VTM alias name from AMP (multiple Virtual Therapeutic Moiety (VTM) Alias name MTT Identifier : Route
Route description Route preferred term from Route concept
MTT identifier : Dose form
Dose Form description Dose form description from Dose form concept Copy "Dose form level extra information" from Dose form level extra information AMP concept
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Attribute
Properties
MTT identifier : Ingredient substance
Ingredient (multiple entries) (multiple entries)
Ingredient
Ingredient description substance concept (multiple entries)
Allergy check flag [Y/N] MTT identifier : VTM+Route
VTM+Route description from VTM+Route
VTM+Route description [TBC] MTT concept stage Last update date 4.4.2 Virtual Therapeutic Moiety Route Dose Form Descriptions Depending on whether the product concept is a single or multiple ingredient product, the Fully Specified Name of a Virtual Therapeutic Moiety Routed Dose Form follows the syntax: i. Single ingredient VTM+R+F: VTM+R+F FSN = "Ingredient_details" + "route" + "Dose Form" ii. Multi-ingredient VTM+R+F: VTM+R+F FSN = "Ingredient_details_1" + "ingredient_details_2" + "route" + "Dose Form" The components are described as: Ingredient_details is the alphabetical list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). 4.4.2.1 Virtual Therapeutic Moiety Routed Dose Form "Fully Specified Description
MTT-VTMF -FSN-1
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in Appendix apply. MTT- VTMF -FSN-2
The VMP name will be derived from the base or salt of the active ingredients, as defined in VTM FSN and PT. MTT- VTMF -FSN-3
The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case MTT- VTMF -FSN-4
Route The route of administration will include information on how the product should be used, as specified in the product's insert. MTT- VTMF -FSN-5
The dose form is derived from the Qualifier Table. The form expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) MTT- VTMF -FSN-6
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.4.2.2 Virtual Therapeutic Moiety Routed Dose Form "Preferred Term" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Specified Name of a Virtual Therapeutic Moiety Routed Dose Form follows the syntax: i. Single ingredient VTM+R+F: VTM+R+F PT = "Ingredient_details" + "route" + "Dose Form" ii. Multi-ingredient VTM+R+F: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) VTM+R+F PT = "Ingredient_details_1" + "ingredient_details_2" + "route" + "Dose Form" The components are described as: Description
Definition
Ingredient_details is the alphabetical list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Ingredient strength*
The amount of the active ingredient in each dose form; for multi-ingredient products, ingredient strength value and unit should follow their respective ingredient details, such that the description tells the amount of each active ingredient per the unit dose form. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). 4.4.2.3 Virtual Therapeutic Moiety Routed Dose Form "Preferred Term" Description
MTT- VTMF -PT-1
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. MTT- VTMF -PT-2
The VMP PT will be derived from the base or salt of the active ingredients, as defined in VTM PT. MTT- VTMF -PT-3
The Virtual Medicinal Product PT will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case MTT- VTMF -PT-4
Route: The route of administration will include information on how the product should be used, as specified in the product's insert. MTT- VTMF -PT-5
Dose Form: The dose form is derived from the Qualifier Table. The form Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) MTT- VTMF -PT-6
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) VIRTUAL MEDICINAL PRODUCT (VMP) 4.5.1 Virtual Medicinal Product Definition A Virtual Medicinal Product (VMP) is the abstract concept representing the properties of one or more clinical equivalent Trade Products (Actual Medicinal Products (AMP)). The VMP describes a generic product without supplier or trade name information. Equivalent AMPs are defined as those product with the same base active ingredient (with our without the salt, whichever is therapeutically significant), same strength, dose form, and administrable unit type (i.e. same combination of dose unit concepts associated), and being quantitatively bioequivalent. A new VMP will be created for each different strength of a registered pharmaceutical product. If an existing generic product has a change of ingredient, such that it does not conform to the ingredients of the original VMP, then a new VMP will be created for the new product. The existing VMP may have its status changed if no bioequivalent AMP exists. In addition, all VMP concepts will have relationships to all of their active ingredients, as identified by the "has_active_ingredient" relationship. Drug VMPs will usually follow the format of Drug Name + Route + Dose Form + Strength. Examples of VMP concepts FSNs and PTs: Fully Specified Name
Preferred Term
cefalexin oral capsule 250 mg
cefalexin oral capsule 250 mg calcium carbonate oral chewable calcium carbonate oral chewable tablet 1 g
tablet 1 g
betamethasone
valerate) betamethasone (as valerate) topical cream 0.1 %
topical cream 0.1 %
venlafaxine (as hydrochloride) venlafaxine (as hydrochloride) oral modified-
oral modified-release capsule 150 release capsule 150 mg
mg
prednisolone
sodium prednisolone (as sodium metasulfobenzoate)
metasulfobenzoate) rectal foam rectal foam 20 mg / 1 application
20 mg / 1 application
povidone iodine topical solution povidone iodine topical solution 10 %
10 %
dimenhydrinate oral syrup 15 mg dimenhydrinate oral syrup 15 mg / 5 mL
acyclovir oral tablet 200 mg
acyclovir oral tablet 200 mg Other additional information will be maintained as either at dose form level extra information, or strength level extra information (see below). Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 4.5.1.5 Dose Form Level Extra Information These include the "free-ness" information (such as sugar-free, preservative-free or alcohol-free products) and other related property that is conferred by the dose form. Dose form level extra information may also include the supplied physical form of certain products, as a supplementary information to dose form. specific examples include insulin products, for which additional information on the actual supplied form can be included as dose form level extra information (refer to Chapter 6.2.4 on exception details for insulin products.) Examples of preferred terms for products with such properties: Dose form level extra Preferred term
information
CFC-free
salbutamol (as sulfate) inhalation pressurised inhalation (CFC-free) 100 microgram / actuation beclomethasone dipropionate inhalation pressurised inhalation (CFC-free) 250 microgram / actuation beclomethasone dipropionate inhalation pressurised inhalation (CFC-free) 50 microgram / actuation beclomethasone dipropionate inhalation pressurised inhalation (CFC-free) 100 microgram / actuation beclomethasone dipropionate inhalation pressurised inhalation (CFC-free) 250 microgram / actuation ipratropium bromide inhalation pressurised inhalation (CFC-free) 20 microgram / actuation adrenaline (as acid tartrate) pareneteral injection (preservative-free) 1:1000 adrenaline (as acid tartrate) pareneteral injection (preservative-free) 1:1000 Sugar-free
acetylcysteine oral granules (sugar-free) 100 mg / sachet acetylcysteine oral granules (sugar-free) 200 mg / sachet benzydamine hydrochloride buccal lozenge (sugar-free) 3mg colestyramine oral granules (sugar-free) 4 g / sachet polacrilex
nicotine buccal chewing gum (polacrilex) 2 mg nicotine buccal chewing gum (polacrilex) 4 mg nicotine buccal chewing gum (polacrilex) 2 mg nicotine buccal chewing gum (polacrilex) 2 mg nicotine buccal chewing gum (polacrilex) 2 mg cartridge
insulin aspart subcutaneous solution for injection (cartridge) 100 international unit / mL (3 mL) insulin detemir subcutaneous solution for injection (pen) 100 international unit / mL (3 mL) insulin isophane human subcutaneous suspension for injection (vial) 100 international unit / mL (10 mL) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 4.5.1.6 Strength Level Extra Information Some products are available in a range of flavours or colours – these will be maintained as strength level extra information. The default method for expressing strength of parenteral product is the express the total quantity of drug in the total volume; in exceptional cases where injectable product strength expressed without the total volume, this information may be maintained as strength level extra information (a specific example is insulin products - refer to Appendix K section 6.12.3 on exception details for insulin products.) Strength
level Preferred Term
extra information
nicotine buccal chewing gum (polacrilex) 2 mg (fruit) psyllium hydrophilic mucilloid fiber oral granules 3.4 g / dose Flavours
(orange) nicotine buccal chewing gum (polacrilex) 2 mg (freshmint) nicotine buccal chewing gum (polacrilex) 2 mg (mint) aspirin oral tablet 80 mg (orange) chlorhexidine acetate topical irrigation solution 0.02 % (blue) 4.5.1.7 Combination Products For VMPs which contains multiple ingredients, the VTM will be maintained in a manner where each active ingredients (within the same VTM component) ""ingredient_name_1" "ingredient_name_2" + {"Ingredient_name_n""; in VMP, products of varying amount of these active substances will have the ingredient strengths added adjacent to the corresponding ingredient names (see below for details). 4.5.1.8 Associations Ascending association:

Virtual Medicinal Product (VMP) IS_A Virtual Therapeutic
Moiety Routed Dose Form (VTM+Route+Form) concept
ii. Descending association:
No descending association iii. Attributable association:
Virtual Medicinal Product (VMP) Is equiv to SCT SNOMED CT
identifier
Virtual Medicinal Product (VMP) Has active ingredient
substance
Virtual Medicinal Product (VMP) Has BoSS substance
Virtual Medicinal Product (VMP) Has ingredient unit of measure
unit of measure
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Virtual Medicinal Product (VMP) Has base unit base unit
Virtual Medicinal Product (VMP) Has dispensing dose unit
dispensing dose unit
Virtual Medicinal Product (VMP) Has prescribing dose unit
prescribing dose unit concept
Virtual Medicinal Product (VMP) Has therapeutic classification
therapeutic classification concept
Attributes
Attribute
Properties
Virtual Medicinal Product (VMP) conceptID SNOMED CT ConceptID SNOMED CT Identifier "VTM preferred term" "Route" "DoseForm" VMP Fully specified name "Strength" "VTM preferred term" "Route" "DoseForm" VMP Preferred term "Strength" "DoseForm" "Strength" Virtual Therapeutic Moiety (VTM) preferred String Virtual Therapeutic Moiety (VTM) shortname Virtual Therapeutic Moiety (VTM) Alias name String (multiple entries) MTT Identifier : Route
Route description Route preferred term from Route concept
MTT identifier : Dose form
Dose form description Doseform_PT from Dose form
Copy "Dose form level extra information" from Dose form level extra information AMP concept
Copy "strength" from AMP concept
Copy "Strength level extra information" from Strength level Extra Information AMP concept
Ingredient
substance
(multiple entries)
Ingredient substance PT from Ingredient
Ingredient description substance concept (multiple entries)
Allergy check flag [Y/N] Ingredient
substance
Dose unit group (per BoSS) (multiple entries)
Ingredient strength value (per BoSS) numerical (multiple entries) MTT identifier : Ingredient strength unit
Ingredient strength unit (per Boss) (multiple entries)
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Attribute
Properties
Ingredient unit of measure value Ingredient unit of measure unit MTT identifier : Ingredient Unit of measure
Ingredient unit of measure description from
Ingredient unit of measure description Ingredient unit of measure concept
MTT identifier : Base Unit
Base Unit PT description from Base unit
Base unit description Prescribing dose unit MTT Identifier : Prescribing dose unit
Prescribing dose unit preferred term from Prescribing dose unit description Prescribing dose unit concept
Dispensing dose unit MTT Identifier : Dispensing dose unit
Dispensing dose unit preferred term from Dispensing dose unit description Prescribing dose unit concept
Therapeutic Classification MTT Identifier : Therapeutic classifications
Therapeutic classifications preferred term from Therapeutic Classification Description Therapeutic Classification concept
IS_A VTM+Route+Form MTT identifier : VTM+Route+Form
VTM+Route+Form description VTM+Route+Form concept
Supporting documents (Product insert / master formula) [TBC] MTT concept stage Last update date 4.5.2 Virtual Medicinal Product Descriptions 4.5.2.1 Virtual Medicinal Product "Fully Specified Name" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Specified Name of a Virtual Medicinal Product follows the syntax: i. Single ingredient VMP: VMP FSN = "Ingredient_details" + "route" + "Dose Form" + "strength" ii. Multi-ingredient VMP: VMP FSN = "Ingredient_details_1" + "Ingredient_strength_1" + "ingredient_details_2" + "ingredient strength_2" + "route" + "Dose Form" Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) The components are described as: Description
Definition
Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Ingredient strength*
The amount of the active ingredient in each dose form; for multi-ingredient products, ingredient strength value and unit should follow their respective ingredient details, such that the description tells the amount of each active ingredient per the unit dose form. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). strength*
The expression of strength of the unit dose form (not individual component. For multiple ingredient products, each ingredient_details will have their own corresponding strength next to the ingredient name; for single ingredient products, the strength will follow the dose form. 4.5.2.2 Virtual Medicinal Product "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalization" apply. The VMP name will be derived from the base or salt of the active ingredients, as defined in VTM FSN and PT. The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Route The route of administration will include information on how the product should be used, as specified in the product's insert. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Dose Form The dose form is derived from the Qualifier Table. The form expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) Strength expression The VMP FSN will include strength expression (if available). The strength expression general rules and strength expression for specific dose form rules is outlined in section 3.2 The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.5.2.3 Virtual Medicinal Product "Preferred Term" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Specified Name of a Virtual Medicinal Product follows the syntax: i. Single ingredient VMP: VMP PT= "Ingredient_details" + "route" + "Dose Form" + "strength" ii. Multi-ingredient VMP: VMP PT = "Ingredient_details_1" + "Ingredient_strength_1" + "ingredient_details_2" + "ingredient strength_2" + "route" + "Dose Form" The components are described as: Description
Definition
Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Ingredient strength*
The amount of the active ingredient in each dose form; for multi-ingredient products, ingredient strength value and unit should follow their respective ingredient details, such that the description tells the amount of each active ingredient per the unit dose form. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). strength*
The expression of strength of the unit dose form (not individual component. For multiple ingredient products, each ingredient_details will have their own corresponding strength next to the ingredient name; for single ingredient products, the strength will follow the dose form. 4.5.2.4 Virtual Medicinal Product "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. The VMP PT will be derived from the base or salt of the active ingredients, as defined in VTM PT. The Virtual Medicinal Product PT will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Route: The route of administration will include information on how the product should be used, as specified in the product's insert. Dose Form: The dose form is derived from the Qualifier Table. The form expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) Strength expression: The VMP PT will include strength expression (if available). The strength expression general rules and strength expression for specific dose form rules is outlined in section 3.2 The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Trade Name (TradeName) 4.6.1 Trade Name Definition A Trade Name represents the product brand name or the grouping of products into a "family" of trade products with the same description, for either single ingredient products that contain the same base of an active ingredient or components of multi-ingredient products which contain the same combination of bases of the active substances. 4.6.1.2 Associations Ascending association:

No ascending association ii. Descending association: Routed Trade Name (TradeName+Route) IS_A Trade Name
(TradeName)
(A single Trade Name may be associated with one or multiple
entities of Routed Trade Names)
iii. Attributable association: Trade Name (TradeName) is trade equiv of Virtual Therapeutic
Moiety (VTM)
Attributes
Attribute
Properties
TradeName concept ID TradeName preferred term "TradeName" "("VTM preferred term")" TradeName fully specified name "TradeName" "("VTM preferred term")" Virtual Therapeutic Moiety (VTM) preferred term Copy VTM preferred term from AMP Virtual Therapeutic Moiety (VTM) Alias name Copy VTM alias name from AMP Virtual Therapeutic Moiety (VTM) shortname Copy VTM preferred term from AMP Generic product indicator [Y/N] Ingredient (multiple entries) MTT identifier : substance (multiple entries)
substance PT from substance concept (multiple
Ingredient description Allergy check flag [Y/N] Is_trade_equiv_of VTM conceptID MTT Identifier : VTM
VTM+Route preferred term from VTM concept
MTT concept stage Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Last update date 4.6.2 Trade Name Descriptions 4.6.2.1 Trade Name "Fully Specified Name" Definition Depending on (i) whether the product concept is a single or multiple ingredient product; and (ii) proprietary or non-proprietary (generic), the Fully Specified Name of a Trade Name follows the syntax: i. Single ingredient TN, Proprietary product: TN FSN = "TradeName" + "(""Ingredient_details"")" ii. Single ingredient TN, Non-proprietary product: TN FSN = "TradeName" iii. Multi-ingredient TN, Proprietary product: iv. Multi- ingredient TN, Non-proprietary product: TN FSN = "TradeName" The components are described as: Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. 4.6.2.2 Trade Name "Fully Specified Name" Rules Description
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalization" apply. The VMP name will be derived from the base or salt of the active ingredients, as defined in VTM FSN and PT. The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.6.2.3 Trade Name "Preferred Term" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Preferred Term of a Trade Name follows the syntax: i. Single ingredient TN, Proprietary product: TN PT = "TradeName" + "(""Ingredient_details"")" ii. Single ingredient TN, Non-proprietary product: TN PT = "TradeName" iii. Multi-ingredient TN, Proprietary product: TN PT = "TradeName" + "(""Ingredient_details_1" + "ingredient_details_2"")" iv. Multi- ingredient TN, Non-proprietary product: TN PT = "TradeName" The components are described as: Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. 4.6.2.4 Trade Name "Preferred Term" Rules Description
MTT-TN-PT-1
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. MTT-TN-PT-2
The AMP PT will be derived from the base or salt of the active ingredients, as defined in VTM PT. MTT-TN-PT-3
The Virtual Medicinal Product PT will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case MTT- TN -PT-5
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) ROUTED TRADE NAME (TRADE NAME + ROUTE) 4.7.1 Routed Trade Name Definition A Routed Trade Name (TradeName+Route) is the abstract concept representing the administrable route of administration form for a given TradeName concept. 4.7.2 Associations Ascending association:
Routed Trade Name (TradeName+Route) IS_A Trade Name
(TradeName)

Descending association:
Routed Trade Name Dose Form (TradeName+Route+Form) IS_A
Routed Trade Name (TradeName+Route)

iii. Attributable association:
Routed Trade Name (TradeName+Route) Is trade equiv of Routed
Virtual Therapeutic Moiety (VTM+Route)
Attributes
Attribute
Properties
Routed TradeName conceptID Routed TradeName fully specified name "TradeName" "("VTM preferred term")" "Route" Routed TradeName preferred term "TradeName" "("VTM preferred term")" "Route" Virtual Therapeutic Moiety (VTM) preferred term Copy VTM preferred term from AMP Virtual Therapeutic Moiety (VTM) shortname Copy VTM shortname from AMP Copy VTM alias name from AMP (multiple Virtual Therapeutic Moiety (VTM) Alias name Ingredient (multiple entries) MTT identifier : substance (multiple entries)
Ingredient substance PT from substance concept
Ingredient description (multiple entries) Allergy check flag [Y/N] Is_trade_equiv_of VTM+Route conceptID MTT Identifier : VTM+Route
VTM+Route preferred term from VTM+Route
VTM+Route description MTT Identifier : Route
Route description Route preferred term from Route concept
MTT identifier : TradeName
TradeName preferred term from TradeName
TradeName description Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Generic product indicator [Y/N] MTT concept stage Last update date 4.7.3 Routed Trade Name Descriptions 4.7.3.1 Routed Trade Name "Fully Specified Name" Definition Depending on (i) whether the product concept is a single or multiple ingredient product; and (ii) proprietary or non-proprietary (generic), the Fully Specified Name of a Routed Trade Name follows the syntax: Single ingredient TN+R, Proprietary product: TN+R FSN = "TradeName" + "(""Ingredient_details"")" + "route" ii. Single ingredient TN+R, Non-proprietary product: TN+R FSN = "TradeName" + "route" iii. Multi-ingredient TN+R, Proprietary product: TN+R FSN = "TradeName" + "(""Ingredient_details_1" + "ingredient_details_2"")" + "route" iv. Multi- ingredient TN+R, Non-proprietary product: TN+R FSN = "TradeName" + "route" The components are described as: Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). 4.7.3.2 Routed Trade Name "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalization" apply. The VMP name will be derived from the base or salt of the active ingredients, as defined in VTM FSN and PT. MTT-TNR -FSN-3
The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case MTT-TNR -FSN-4
Route The route of administration will include information on how the product should be used, as specified in the product's insert. MTT-TNR -FSN-5
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.7.3.3 Routed Trade Name "Preferred Term" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Preferred Term of a Routed Trade Name follows the syntax: i. Single ingredient TN+R, Proprietary product: TN+R PT = "TradeName" + "(""Ingredient_details"")" + "route" ii. Single ingredient TN+R, Non-proprietary product: TN+R PT = "TradeName" + "route" Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) iii. Multi-ingredient TN+R, Proprietary product: = "TradeName" + "(""Ingredient_details_1" + "ingredient_details_2"")" + "route" iv. Multi- ingredient TN+R, Non-proprietary product: TN+R PT = "TradeName" + "route" The components are described as: Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). 4.7.3.4 Routed Trade Name "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. MTT-TNR -PT-2
The AMP PT will be derived from the base or salt of the active ingredients, as defined in VTM PT. The Virtual Medicinal Product PT will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Route: The route of administration will include information on how the product should be used, as specified in the product's insert. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) MTT- TNR -PT-5
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) ROUTED TRADE NAME DOSE FORM (TRADENAME + ROUTE + FORM) 4.8.1 Routed Trade Name Dose Form Definition A Routed Trade Name Dose Form (TradeName+Route+Form) is the abstract concept representing the available dose form for a given trade name, that is intended to be given via a route as specified. 4.8.2 Associations Ascending association:

Routed Trade Name Dose Form (TradeName+Route+Form) IS_A
Routed Trade Name (TradeName+Route)

ii. Descending association:
Actual Medicinal Product (AMP) IS_A Routed Trade Name Dose
Form (TradeName+Route+Form)
iii. Attributable association:
Routed Trade Name Dose Form (TradeName+Route+Form) Is trade
equiv of Virtual Therapeutic Moiety Routed Dose Form
(VTM+Route+Form)
Attributes
Attribute
Properties
Form MTT identifier (TradeName+Route+Form) conceptID TradeName Routed Dose Form Fully specified "TradeName" "("VTM")" "Route" "DoseForm" TradeName Routed Dose Form Preferred term "TradeName" "("VTM")" "Route" "DoseForm" "TradeName" "("VTM shortname")" "Route" TradeName Routed Dose Form Shortname "DoseForm" Virtual Therapeutic Moiety (VTM) preferred term Copy VTM preferred term from AMP Virtual Therapeutic Moiety (VTM) shortname Copy VTM shortname from AMP Copy VTM alias name from AMP (multiple Virtual Therapeutic Moiety (VTM) Alias name MTT identifier : Ingredient substance (multiple
Ingredient (multiple entries) entries)
Ingredient
Ingredient description substance concept (multiple entries)
Allergy check flag [Y/N] Generic product indicator [Y/N] is_trade_equiv_of VTM+Route+Form conceptID MTT identifier : VTM+Route+Form
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Attribute
Properties
is_trade_equiv_of VTM+Route+Form description VTM+Route+Form concept
MTT Identifier : Route
Route description Route description from Route concept
MTT identifier : Dose form
Dose Form description Dose form description from Dose form concept Copy "Dose form level extra information" from Dose form level extra information AMP concept
IS_A TradeName+Route MTT identifier : TradeName+Route
TradeName+Route description TradeName+Route concept
[TBC] MTT concept stage Last update date 4.8.3 Routed Trade Name Dose Form Descriptions 4.8.3.1 Routed Trade Name Dose Form "Fully Specified Name" Definition Depending on (i) whether the product concept is a single or multiple ingredient product; and (ii) proprietary or non-proprietary (generic), the Fully Specified Name of a Routed Trade Name Dose Form follows the syntax: i. Single ingredient TN+R+F, Proprietary product: TN+R+F FSN = "TradeName" + "(""Ingredient_details"")" + "route" + "Dose Form" + "strength" ii. Single ingredient TN+R+F, Non-proprietary product: TN+R+F FSN = "TradeName" + "route" + "Dose Form" + "strength" iii. Multi-ingredient TN+R+F, Proprietary product: TN+R+F FSN = "TradeName" + "(""Ingredient_details_1" + "Ingredient_strength_1" + "ingredient_details_2" + "ingredient strength_2"")" + "route" + "Dose Form" iv. Multi- ingredient TN+R+F, Non-proprietary product: TN+R+F FSN = "TradeName" + + "route" + "Dose Form" + "strength" The components are described as: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Ingredient strength*
The amount of the active ingredient in each dose form; for multi-ingredient products, ingredient strength value and unit should follow their respective ingredient details, such that the description tells the amount of each active ingredient per the unit dose form. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). 4.8.3.2 Routed Trade Name Dose Form "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalization" apply. The VMP name will be derived from the base or salt of the active ingredients, as defined in VTM FSN and PT. The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Route The route of administration will include information on how the product should be used, as specified in the product's insert. Dose Form The dose form is derived from the Qualifier Table. The form expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.8.3.3 Routed Trade Name Dose Form "Preferred Term" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Preferred Term of a Routed Trade Name Dose Form follows the syntax: i. Single ingredient TN+R+F, Proprietary product: TN+R+F PT = "TradeName" + "(""Ingredient_details"")" + "route" + "Dose Form" + "strength" ii. Single ingredient TN+R+F, Non-proprietary product: TN+R+F PT = "TradeName" + "route" + "Dose Form" + "strength" iii. Multi-ingredient TN+R+F, Proprietary product: PT= "TradeName" + "(""Ingredient_details_1" + "Ingredient_strength_1" + "ingredient_details_2" + "ingredient strength_2"")" + "route" + "Dose Form" iv. Multi- ingredient TN+R+F, Non-proprietary product: TN+R+F PT = "TradeName" + "route" + "Dose Form" +"strength" The components are described as: Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Ingredient strength*
The amount of the active ingredient in each dose form; for multi-ingredient products, ingredient strength value and unit should follow their respective ingredient details, such that the description tells the amount of each active ingredient per the unit dose form. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). 4.8.3.4 Routed Trade Name Dose Form "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. The AMP PT will be derived from the base or salt of the active ingredients, as defined in VTM PT. The Virtual Medicinal Product PT will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Route: The route of administration will include information on how the product should be used, as specified in the product's insert. MTT- TNRF -PT-5
Dose Form: The dose form is derived from the Qualifier Table. The form expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) MTT- TNRF -PT-6
The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) ACTUAL MEDICINAL PRODUCT (AMP) 4.9.1 Actual Medicinal Product Definition An Actual Medicinal Product (AMP) represents a single dose unit of a finished dose form (unless the product is presented as a continuous dosage form such as liquid or cream), and which contains a specified amount of an ingredient substance, and is grouped under a particular TradeName concept. 4.9.2 Associations Ascending association:

Actual Medicinal Product (AMP) IS_A Routed Trade Name Dose Form
(TradeName+Route+Form)
ii. Descending association:
No descending association iii. Attributable association:
Actual Medicinal Product (AMP) Is trade equiv of Virtual Medicinal
Product (VMP)
Actual Medicinal Product (AMP) Has manufacturer manufacturer
Actual Medicinal Product (AMP) Has legal classification legal
classification
Attributes
Attribute
Properties
Actual Medicinal Product (AMP) conceptID "TradeName" "("VTM")" "Route" "DoseForm" AMP Fully specified name "Strength" "TradeName" "("VTM")" "Route" "DoseForm" AMP Preferred term "Strength" "TradeName" "("VTM shortname")" "Route" "DoseForm" "Strength" Virtual Therapeutic Moiety (VTM) preferred term String Virtual Therapeutic Moiety (VTM) shortname Virtual Therapeutic Moiety (VTM) Aliasname String (multiple entries) MTT Identifier : Route
Route description Route preferred term from Route concept
MTT identifier : Dose form
Dose form description Doseform_PT from Dose form
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Attribute
Properties
Ingredient
substance
(multiple entries)
Ingredient
Ingredient description substance concept (multiple entries)
Dose unit group (per BoSS) numerical (multiple entries) Ingredient strength value (per BoSS) numerical (multiple entries) MTT identifier : Ingredient strength unit
Ingredient strength unit (per Boss) (multiple entries)
Ingredient unit of measure value Ingredient unit of measure unit MTT identifier : Ingredient Unit of measure
Ingredient unit of measure description from
Ingredient unit of measure description Ingredient unit of measure concept
MTT identifier : Base Unit
Base unit description Base Unit preferred term from Base unit concept
Prescribing dose unit MTT Identifier : Prescribing dose unit
Prescribing dose unit preferred term from Prescribing dose unit description Prescribing dose unit concept
Dispensing dose unit MTT Identifier : Dispensing dose unit
Dispensing dose unit preferred term from Dispensing dose unit description Prescribing dose unit concept
Therapeutic Classification MTT Identifier : Therapeutic classifications
Therapeutic classifications preferred term from Therapeutic Classification Description Therapeutic Classification concept
Strength level Extra Information Dose form level extra information IS_A TradeName+Route+Form MTT identifier : TradeName+Route+Form
TradeName+Route+Form preferred term from TradeName+Route+Form description TradeName+Route+Form concept
is_trade_equiv_of VMP MTT identifier : VMP
HK Registration no Legal classification MTT identifier : Legal Classification MTT identifier : Manufacturer
Manufacturer description from Manufacturer
Manufacturer description Certificate holder Certificate holder description Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Attribute
Properties
[TBC] MTT concept stage Last update date Supporting documents (Product insert / master Multi-format file type Generic product indicator [Y/N] Allergy check flag [Y/N] 4.9.3 Actual Medicinal Product Descriptions 4.9.3.1 Actual Medicinal Product "Fully Specified Name" Definition Depending on (i) whether the product concept is a single or multiple ingredient product; and (ii) proprietary or non-proprietary (generic), the Fully Specified Name of an Actual Medicinal Product follows the syntax: i. Single ingredient AMP, Proprietary product: AMP FSN = "TradeName" + "(""Ingredient_details"")" + "route" + "Dose Form" + "strength" ii. Single ingredient AMP, Non-proprietary product: AMP FSN = "TradeName" + "route" + "Dose Form" + "strength" iii. Multi-ingredient AMP, Proprietary product: AMP FSN = "TradeName" + "(""Ingredient_details_1" + "Ingredient_strength_1" + "ingredient_details_2" + "ingredient strength_2"")" + "route" + "Dose Form" iv. Multi- ingredient AMP, Non-proprietary product: AMP FSN = "TradeName" + + "route" + "Dose Form" + "strength" The components are described as: Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Ingredient strength*
The amount of the active ingredient in each dose form; for multi-ingredient products, ingredient strength value and unit should follow their respective ingredient details, such that the description tells the amount of each active ingredient per the unit dose form. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). strength*
The expression of strength of the unit dose form (not individual component. For multiple ingredient products, each ingredient_details will have their own corresponding strength next to the ingredient name; for single ingredient products, the strength will follow the dose form. 4.9.3.2 Actual Medicinal Product "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. The VMP name will be derived from the base or salt of the active ingredients, as defined in VTM FSN and PT. The Virtual Medicinal Product name will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Route The route of administration will include information on how the product should be used, as specified in the product's insert. Dose Form The dose form is derived from the Qualifier Table. The form expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Strength expression The VMP FSN will include strength expression (if available). The strength expression general rules and strength expression for specific dose form rules is outlined in section 3.2 The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. 4.9.3.3 Actual Medicinal Product "Preferred Term" Definition Depending on whether the product concept is a single or multiple ingredient product, the Fully Preferred Term of an Actual Medicinal Product follows the syntax: i. Single ingredient AMP, Proprietary product: AMP PT = "TradeName" + "(""Ingredient_details"")" + "route" + "Dose Form" + "strength" ii. Single ingredient AMP, Non-proprietary product: AMP PT = "TradeName" + "route" + "Dose Form" + "strength" iii. Multi-ingredient AMP, Proprietary product: "Ingredient_strength_1" + "ingredient_details_2" + "ingredient strength_2"")" + "route" + "Dose Form" iv. Multi- ingredient AMP, Non-proprietary product: AMP PT = "TradeName" + "route" + "Dose Form" +"strength" The components are described as: Description
Definition
Component
TradeName
TradeName is a product brand name shared by product concepts containing the same active ingredients or components of multi-component products. In the case of generic drug products, the tradename Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) will be populated by including the VTM (single ingredients) or set of VTMs with their corresponding strength, followed by the manufacturer's name in bracket. In which case since such product's generic name has already been expressed in the "tradename", there need not to include the VTM as part of the AMP's full description. Ingredient_details is the list of active ingredient's preferred term. For multi-ingredient products, the VMP should be made up of the Preferred Terms of each listed ingredients, separated by a "+" sign and grouped together to form the "Ingredient_Details", which will subsequently be included as part of the VMP's FSN. Ingredient strength*
The amount of the active ingredient in each dose form; for multi-ingredient products, ingredient strength value and unit should follow their respective ingredient details, such that the description tells the amount of each active ingredient per the unit dose form. The preferred term of the route of administration a generic product. The Route (i.e. route of administration) is a concept pre-defined in the Qualifier concept table; it is the representation of the place or on the body where a medicinal product is introduced in order to achieve desired therapeutic effect (see Qualifier Concept – Appendix 5.2 Route of administration). dose form
The dose form is a concept in the qualifier table used to represent the orderable pharmaceutical form of a VMP or AMP from which the concept derives (see Qualifier Concept – Appendix 5.3 - Dose Form). strength*
The expression of strength of the unit dose form (not individual component. For multiple ingredient products, each ingredient_details will have their own corresponding strength next to the ingredient name; for single ingredient products, the strength will follow the dose form. 4.9.3.4 Actual Medicinal Product "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. The AMP PT will be derived from the base or salt of the active ingredients, as defined in VTM PT. The Virtual Medicinal Product PT will be derived from the actual active ingredients. The full name of an ingredient (including the salt) will be used in all case Route: The route of administration will include information on how the Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) product should be used, as specified in the product's insert. Dose Form: The dose form is derived from the Qualifier Table. The form expressed is the parent form. The dose form will be expressed as a singular form (tablet, capsule, cream) Strength expression: The VMP PT will include strength expression (if available). The strength expression general rules and strength expression for specific dose form rules is outlined in section 3.2 The sequence of active ingredients should be arranged on a case-by-case basis with considerations on: - clinical significance of the ingredient in the medicinal compound; - when one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; This rule applies to all naming of all concepts within MTT where ingredients should be listed in the generic drug name. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFER CONCEPTS
SUBSTANCE CONCEPT: ACTIVE INGREDIENT 5.1.1 Ingredient Substance Definition These are concepts that represent the chemical entities that may act as ingredients of medicinal products:  Complete substances that act as actual active ingredients of medicinal products Basis of strength substance (BoSS) relationship that may or may not exist for a given virtual medicinal product Only active ingredients are listed in HKMTT as ingredients; excipients are not included. 5.1.2 Associations Ascending associations
Active ingredient Is a base ingredient base ingredient
Active ingredient Has allergen group Allergen group
ii. Descending associations
Virtual Therapeutic Moiety has active ingredient active ingredient
Attributes
Attribute
Properties
Ingredient substance concept ID Ingredient substance preferred term Ingredient substance fully specified name "Ingredient substance preferred term" MTT identifier : Base Ingredient
Base ingredient descriptions [multiple Base Ingredient preferred term from Base
Ingredient concept
Allergen group (multiple entries) MTT identifier : Allergen group
Allergen group descriptions (multiple Allergen group preferred term from Allergen Group concept
[TBC] MTT concept stage Last update date Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 5.1.3 Active Ingredient Descriptions 5.1.3.1 Active Ingredient "Fully Specified Name" Definition The Fully Specified Name of an Active Ingredient concept follows the syntax: i. Active Ingredient FSN = "Substance" The components are described as: Description
Definition
Component
The term used to describe the "ingredient substance" 5.1.3.2 Active Ingredient "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.1.3.3 Active Ingredient "Preferred Term" Definition The Preferred Term of a Substance concept follows the syntax: i. Ingredient Substance PT = "Substance" The components are described as: Description
Definition
Component
Substance
The term used to describe the "ingredient substance" 5.1.3.4 Active Ingredient "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: ROUTE 5.2.1 Route Definition i.e. Route of administration. This concept allows for trade products (AMPs) sharing a common set of routes of administration to be grouped together. AMPs grouped under this concept may not necessarily share the set of active ingredient (and strength); hence this concept allows grouping of therapeutically non-identical products, which could be administered via the same method, under the same "trade family". 5.2.2 Associations Ascending association:

No ascending association ii. Descending association:
Routed Virtual Therapeutic Moiety (VTM+Route) has route Route
Routed Trade Name (TradeName+Route) has route Route
Attributes
Attribute
Properties
Route concept ID Route preferred term Route fully specified name "Route preferred term" "("Route")" [TBC] MTT concept stage Last update date 5.2.3 Route of administration Descriptions See Section 6.4 "Appendix D – Route" for list of defined route of administration that are currently maintained and used as structural data for product concepts. 5.2.3.1 Route of administration "Fully Specified Name" Definition The Fully Specified Name of a Route of Administration concept follows the syntax: i. Route FSN = "Route" The components are described as: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
Definition
Component
The term used to describe the "Route of administration" 5.2.3.2 Route of administration "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.2.3.3 Route of administration "Preferred Term" Definition The Preferred Term of a Route concept follows the syntax: i. Route PT = "Route" The components are described as: Description
Definition
Component
The term used to describe the "Route of administration" 5.2.3.4 Route of administration "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply MTT-RT-PT-1
Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: DOSE FORMS 5.3.1 Dose Form Definition This qualifier concepts describes the dose formulation, such as capsules, tablets, injections. The dose form is referred to as the manufactured dose form in which the product is manufactured and transported. 5.3.2 Associations Ascending association:

No ascending association ii. Descending association:
Routed Dose Form Virtual Therapeutic Moiety (VTM+Route+Form)
has dose form Dose form
Routed Dose Form TradeName (TradeName+Route+Form) has dose
form Dose form
Attributes
Attribute
Properties
Dose form concept ID Dose form preferred term "Dose form preferred term" "("Dose Dose form fully specified name [TBC] MTT concept stage Last update date 5.3.3 Dose Form Descriptions See Section 6.5 "Appendix E – Dose Form" for list of defined Dose Forms that are currently maintained and used as structural data for product concepts. 5.3.3.1 Dose Form "Fully Specified Name" Definition The Fully Specified Name of a Dose Form concept follows the syntax: i. Dose Form FSN = "Dose Form" The components are described as: Description
Definition
Component
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Dose Form
The term used to describe the "Dose Form" 5.3.3.2 Dose Form "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.3.3.3 Dose Form "Preferred Term" Definition The Preferred Term of a Dose Form concept follows the syntax: i. Dose Form PT = "Dose Form" The components are described as: Description
Definition
Component
Dose Form
The term used to describe the "Dose Form" 5.3.3.4 Dose Form "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply MTT-DF-PT-1
Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: INGREDIENT STRENGTH UNITS 5.4.1 Ingredient Strength Units Definition Strength units are one of the unit of measures used to describe or measure quantities within the HKMTT. Strength unit represents amount of active drugs, in terms of the basis of substance strength of a particular ingredient substance, contained in a VMP. 5.4.2 Associations Ascending association:

No ascending association ii. Descending association:
Virtual Medicinal Product (VMP) has ingredient strength unit
ingredient strength unit
Actual Medicinal Product (AMP) has ingredient strength unit
ingredient strength unit
Attributes
Attribute
Properties
Ingredient strength unit concept ID Ingredient strength unit preferred term Ingredient strength unit fully specified "ingredient strength unit" "("ingredient strength unit")" [TBC] MTT concept stage Last update date 5.4.3 Ingredient Strength Units Description See Section 6.6 "Appendix F – Strength Unit" for list of defined strength units that are currently maintained and used as structural data for product concepts. 5.4.3.1 Ingredient Strength Units "Fully Specified Name" Definition The Fully Specified Name of a Ingredient Strength Unit concept follows the syntax: i. Ingredient Strength Unit FSN = "Ingredient Strength Unit" The components are described as: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
Definition
Component
Ingredient
Strength The term used to describe the "Ingredient Strength Unit".
5.4.3.2 Ingredient Strength Units "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.4.3.3 Ingredient Strength Units "Preferred Term" Definition The Preferred Term of an Ingredient Strength Unit concept follows the syntax: i. Ingredient Strength Unit PT = "Ingredient Strength Unit" The components are described as: Description
Definition
Component
Ingredient
Strength The term used to describe the "Ingredient Strength Unit"
5.4.3.4 Ingredient Strength Units "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: INGREDIENT UNIT OF MEASURE 5.5.1 Ingredient Unit of Measure Definition Ingredient unit of measures are used to describe or measure quantities within the HKMTT. Dose units describe the quantitative amount of unit that is available in a single "unit of use". For example, an injection with unit of use in terms of a vial containing 5mL of a injectable fluid would be described to having 5 millilitres of dose unit. 5.5.2 Associations Ascending association:

No ascending association ii. Descending association:
Virtual Medicinal Product (VMP) has ingredient unit of measure
ingredient unit of measure
Actual Medicinal Product (AMP) has ingredient unit of measure
ingredient unit of measure
Attributes
Attribute
Properties
Ingredient unit of measure concept ID Ingredient unit of measure preferred term Ingredient unit of measure fully specified "ingredient unit of measure preferred term" "("ingredient unit of measure")" [TBC] MTT concept stage Last update date 5.5.3 Ingredient Unit of Measure Description See Section 6.7 "Appendix G – Units of Measure" for list of defined UOMs that are currently maintained and used as structural data for product concepts. 5.5.3.1 Ingredient Unit of Measure "Fully Specified Name" Definition The Fully Specified Name of Ingredient Unit of Measure concept follows the syntax: i. Ingredient Unit of Measure FSN = "Ingredient Unit of Measure" The components are described as: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
Definition
Component
Ingredient unit of The term used to describe the "Ingredient unit of measure".
5.5.3.2 Ingredient Unit of Measure "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.5.3.3 Ingredient Unit of Measure "Preferred Term" Definition The Preferred Term of an Ingredient Strength Unit concept follows the syntax: i. Ingredient unit of measure PT = "Ingredient unit of measure" The components are described as: Description
Definition
Component
Ingredient
Strength The term used to describe the "Ingredient Unit of Measure"
5.5.3.4 Ingredient Unit of Measure "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: BASE UNIT 5.6.1 Base Unit Definition Base unit describes the actual administrable unit(s) for a particular drug. For
example, a 20mg tablet will have an administrable unit of a single "1 tablet",
whereas in the case of an injectable vial, each 5mL vial will have a unit of use as
a single "1 vial".
5.6.2 Associations Ascending association:

No ascending association ii. Descending association:
Virtual Medicinal Product (VMP) has base unit Base unit
Actual Medicinal Product (AMP) has base unit Base unit
Attributes
Attribute
Properties
Base Unit Concept ID "Base Unit preferred term" "("Base Base Unit Fully Specified Name Base Unit preferred term [TBC] MTT concept stage Last update date 5.6.3 Base Unit Description See Section 6.8 "Appendix H – Base Unit" for list of defined base units that are currently maintained and used as structural data for product concepts. 5.6.3.1 Base Unit "Fully Specified Name" Definition The Fully Specified Name of Base Unit concept follows the syntax: i. Base Unit FSN = "base unit" The components are described as: Description
Definition
Component
Ingredient unit of The term used to describe the "Base Unit"
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 5.6.3.2 Base Unit "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.6.3.3 Base Unit "Preferred Term" Definition The Preferred Term of a base Unit concept follows the syntax: i. Base Unit PT = "Base Unit" The components are described as: Description
Definition
Component
Ingredient
Strength The term used to describe the "Base Unit"
5.6.3.4 Base Unit "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply MTT-BU-PT-1
Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: PRESCRIBING DOSE UNIT 5.7.1 Prescribing Dose Unit Definition A Prescribing dose unit describes the actual prescribable unit(s) for a particular
drug. For example, a 20mg tablet will have a prescribable unit of a "mg"
5.7.2 Associations Ascending association:

No ascending association ii. Descending association:
Virtual Medicinal Product (VMP) has prescribing dose unit
Prescribing dose unit
Actual Medicinal Product (AMP) has prescribing dose unit
Prescribing dose unit
Attributes
Attribute
Properties
Prescribing dose unit concept ID Prescribing dose unit preferred fully "prescribing dose unit preferred term" "("prescribing dose unit")" [TBC] MTT concept stage Last update date 5.7.3 Prescribing Dose Unit Description See Section 6.9 "Appendix I – Prescribing Dose Unit" for list of defined prescribing units that are currently maintained and used as structural data for product concepts. 5.7.3.1 Prescribing Dose Unit "Fully Specified Name" Definition The Fully Specified Name of Base Unit concept follows the syntax: i. Prescribing Dose Unit FSN = "Prescribing Dose Unit" The components are described as: Description
Definition
Component
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Prescribing Dose Unit The term used to describe the "Prescribing Dose Unit"
5.7.3.2 Prescribing Dose Unit "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.7.3.3 Prescribing Dose Unit "Preferred Term" Definition The Preferred Term of a Prescribing Dose Unit concept follows the syntax: i. Prescribing Dose Unit PT = "Prescribing Dose Unit" The components are described as: Description
Definition
Component
Ingredient
Strength The term used to describe the "Prescribing Unit"
5.7.3.4 Prescribing Dose Unit "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: DISPENSING DOSE UNIT 5.8.1 Dispensing Dose Unit Definition Dispensing dose unit describes the actual unit(s) that could physically be
dispensed for a particular drug. For example, a 20mg tablet will have a
dispensing unit of a single "1 tablet", whereas in the case of an injectable vial,
each 5mL vial will have a unit of use as a single "1 vial".
5.8.2 Associations Ascending association:

No ascending association ii. Descending association:
Virtual Medicinal Product (VMP) has dispensing dose unit
Dispensing dose unit
Actual Medicinal Product (AMP) has dispensing dose unit
Dispensing dose unit
Attributes
Attribute
Properties
Dispensing dose unit concept ID Dispensing dose unit preferred term "dispensing dose unit preferred term" Dispensing dose unit fully specified name "("dispensing dose unit")" [TBC] MTT concept stage Last update date 5.8.3 Dispensing Dose Unit Description See Section 6.10 "Appendix J – Dispensing Dose Unit" for list of defined dispensing units that are currently maintained and used as structural data for product concepts. 5.8.3.1 Dispensing Dose Unit "Fully Specified Name" Definition The Fully Specified Name of Dispensing Unit concept follows the syntax: i. Dispensing Dose Unit FSN = "Dispensing Dose Unit" The components are described as: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
Definition
Component
Dispensing Dose Unit
The term used to describe the "Dispensing Dose Unit" 5.8.3.2 Dispensing Dose Unit "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.8.3.3 Dispensing Dose Unit "Preferred Term" Definition The Preferred Term of a Prescribing Dose Unit concept follows the syntax: i. Dispensing Dose Unit PT = "Dispensing Dose Unit" The components are described as: Description
Definition
Component
Dispensing Dose Unit
The term used to describe the "Dispensing Dose Unit" 5.8.3.4 Dispensing Dose Unit "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) QUALIFIER CONCEPT: MANUFACTURER 5.9.1 Manufacturer Definition Manufacturers are pharmaceutical manufacturers that are included as part of the
product information for a given Actual Medicinal Product.
The short description of the manufacturer may be populated as part of the trade
name for generic manufacturers, where the product may not necessary carry a
trade name (e.g. the short name "(DBL)" for "adrenaline (as acid tartrate) (DBL)
parenteral injection 1:1000"
5.9.2 Associations Ascending association:

No ascending association ii. Descending association:
Actual Medicinal Product (AMP) has manufacturer Manufacturer
Attributes
Attribute
Properties
Manufacturer concept ID Manufacturer preferred term "Manufacturer Manufacturer fully specified name [TBC] MTT concept stage Last update date 5.9.3 Manufacturer Description 5.9.3.1 Manufacturer "Fully Specified Name" Definition The Fully Specified Name of Manufacturer the syntax: i. Manufacturer FSN = "Manufacturer" The components are described as: Description
Definition
Component
The term used to describe the "manufacturer" 5.9.3.2 Manufacturer "Fully Specified Name" Rules Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.9.3.3 Manufacturer "Preferred Term" Definition The Preferred Term of a manufacturer concept follows the syntax: i. Manufacturer PT = "manufacturer" The components are described as: Description
Definition
Component
The term used to describe the "Manufacturer" 5.9.3.4 Manufacturer "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 5.10 QUALIFIER CONCEPT: LEGAL CLASSIFICATIONS 5.10.1 Legal Classification Definition Legal Classification is the legal classification of a pharmaceutical product,
assigned by the Department of Health.
5.10.2 Associations Ascending association:

No ascending association Descending association:
Actual Medicinal Product (AMP) has legal classification legal
classification
Attributes
Attribute
Properties
Legal classification Concept ID " Legal classification preferred term" "(" Legal classification Fully Specified Name Legal classification ")" Legal classification preferred term [TBC] MTT concept stage Last update date 5.10.3 Legal Classification Description See Section 6.12 "Appendix L – Legal Classification" for list of defined legal classes that are currently maintained and used as structural data for product concepts. 5.10.3.1 Legal Classification "Fully Specified Name" Definition The Fully Specified Name of Legal Classification the syntax: Legal Classification FSN = "Legal Classification" The components are described as: Description
Definition
Component
Legal classification
The term used to describe the "legal classification." 5.10.3.2 Legal Classification "Fully Specified Name" Rules Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.10.3.3 Legal Classification "Preferred Term" Definition The Preferred Term of a legal classification concept follows the syntax: i. Legal classification PT = "Legal classification" The components are described as: Description
Definition
Component
Legal classification
The term used to describe the "legal classification" 5.10.3.4 Legal Classification "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply MTT-LC-PT-1
Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 5.11 SUBSTANCE CONCEPT: ALLERGEN GROUP 5.11.1 Allergen Group Definition Allergen group represents a patient's allergy to a group of chemically-
related ingredients. It is either a group of chemically similar drugs known to
have similar allergenic potential or to a single drug entity.
For example, the allergen group concept ID for Penicillin, Amoxicillin, and
Piperacillin is the same, combining chemically similar drugs into one group. If
a patient is allergic to penicillin, the potential exists for the patient to be allergic
to all drugs with the same allergen group concept ID as penicillin. The allergen
group can also be used for a single drug ingredient documented to have
allergenic potential.
5.11.2 Associations Ascending association:

No ascending association ii. Descending association:
Active Ingredient has allergen group Allergen group; or
Base Ingredient has allergen group Allergen group
Attributes
Attribute
Properties
Allergen group concept ID Allergen group preferred term Allergen group fully specified name "(Allergen group")" Cross-sensitivity Group (multiple entries) MTT identifier : Cross-sensitivity Group Cross-sensitivity description Cross-sensitivity group preferred term (multiple entries) from Cross-sensitivity group concept
Display in allergen list [Y/N] [TBC] MTT concept stage Last update date 5.11.3 Allergen Group Description 5.11.3.1 Allergen Group "Fully Specified Name" Definition The Fully Specified Name of an Allergen Group follows the syntax: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Allergen Group FSN = "Allergen Group " The components are described as: Description
Definition
Component
Allergen group
The term used to describe the "allergen group" 5.11.3.2 Allergen Group "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.11.3.3 Allergen Group "Preferred Term" Definition The Preferred Term of an Allergen Group concept follows the syntax: Allergen Group PT = "Allergen Group" The components are described as: Description
Definition
Component
Allergen Group
The term used to describe the "Allergen Group" 5.11.3.4 Allergen Group "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 5.12 SUBSTANCE CONCEPT: CROSS SENSITIVITY GROUP 5.12.1 Cross-sensitivity Group Definition: Cross-sensitivity group represents a group of ingredients that exhibit a risk of
cross-sensitive allergic reactions. Patients who are allergic to an ingredient that
belongs to one specific allergen group might suffer a cross-sensitive allergic
reaction to an ingredient that belongs to a different specific allergen group. The
cross-sensitive allergen groups catch cases like this and provide a second layer
of allergy screening. Drugs in cross- sensitivity group have shown some degree
of cross-allergenicity, and are chemically related or structurally related to the
primary allergen.
5.12.2 Associations Ascending association:

No ascending association ii. Descending association:
Allergen group has cross-sensitivity group Cross-sensitivity group
Attributes
Attribute
Properties
Cross-sensitivity group concept ID Cross-sensitivity group preferred term Cross-sensitivity group fully specified "Cross-sensitivity group preferred term" [TBC] MTT concept stage Last update date 5.12.3 Cross-sensitivity Description 5.12.3.1 Cross-sensitivity Group "Fully Specified Name" Definition The Fully Specified Name of a Cross-sensitivity Group follows the syntax: Cross-sensitivity Group FSN = "Cross-sensitivity Group" The components are described as: Description
Definition
Component
Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) The term used to describe the "cross-sensitivity group" 5.12.3.2 Cross-sensitivity Group "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.12.3.3 Cross-sensitivity Group "Preferred Term" Definition The Preferred Term of a Cross-sensitivity Group concept follows the syntax: Cross-sensitivity Group PT = "Cross-sensitivity Group" The components are described as: Description
Definition
Component
The term used to describe the "cross-sensitivity group" 5.12.3.4 Cross-sensitivity Group "Preferred Term" Rules Description
All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 5.13 LINKAGE CONCEPT: RELATIONSHIP (LINKAGE) CONCEPTS 5.13.1 Qualifier concept: MTT Relationships Definition Definition: Relationship (Linkage) concepts are used to identify the type of
relationship being using within the MTT. The MTT will include SNOMED CT
relationships and HKMTT relationships which are used to:

Define relationship between concepts Add qualifier or substance information to a concept
AMT relationships include:
MTT Relationships
Relationship source
SNOMED CT
has active ingredient
SNOMED CT
route of administration
SNOMED CT
Is equiv to sct
Is trade equiv of
Has allergen group
Has base ingredient
Has base unit
Has cross sensitivity group
Has dispensing dose unit
Has dose form
Has ingredient strength unit
Has ingredient unit of measure
Has manufacturer
Has prescribing dose unit
Has therapeutic classification
Has legal classification
5.13.2 Linkage concept: MTT Relationships Descriptions 5.13.2.1 Relationship Type "Fully Specified Name" Definition The Fully Specified Name of a Relationship Type follows the syntax: Relationship type FSN = "Relationship type" The components are described as: Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Description
Definition
Component
Relationship type
The term used to describe the "relationship type" 5.13.2.2 Relationship Type "Fully Specified Name" Rules Description
All rules in "Fully Specified Name definition and Rules" apply Capitalisation rules as defined in "Appendix A – Capitalisation" apply. 5.13.2.3 Relationship Type "Preferred Term" Definition The Preferred Term of a Relationship Type concept follows the syntax: Relationship type PT = "Relationship type Group" The components are described as: Relationship type The term used to describe the "relationship type" 5.13.2.4 Relationship Type "Preferred Term" Rules All rules in "Preferred Term definition and Rules" apply Capitalisation rules as defined in Appendix apply. Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) 5.13.3 MTT Relationship List Defining
Ref Source concept
System-assigned relationships
Target concept
Inferred
Hong Kong Pharmaceutical Product SNOMED CT Identifier Has_active_ingredient Property : allergy check flag SNOMED CT Identifier Has_active_ingredient Property : allergy check flag SNOMED CT Identifier Property : Dose form level extra Has_active_ingredient Property : allergy check flag SNOMED CT Identifier Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) per each has_active_ingredient numerical (multiple entries) has_BoSS MTT identifier : Ingredient strength unit (multiple entries) Has_ingredient_unit_of_measure value numerical (multiple entries) MTT identifier : Ingredient Unit of Prescribing dose unit Dispensing dose unit Has_active_ingredient Property : allergy check flag Property : Dose form level extra Hong Kong Pharmaceutical Product is_trade_equiv_of Has_active_ingredient Property : Generic product indicator Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Has_active_ingredient Property : allergy check flag is_trade_equiv_of Has_active_ingredient Property : allergy check flag Property : Generic product indicator TradeName+Route+Form is_trade_equiv_of TradeName+Route+Form TradeName+Route+Form MTT identifier : TradeName+Route Property : Dose form level extra TradeName+Route+Form TradeName+Route+Form Has_active_ingredient TradeName+Route+Form Property : allergy check flag TradeName+Route+Form Property : Generic product indicator TradeName+Route+Form Prescribing dose unit Dispensing dose unit Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Has_Manufacturer Legal classification Has_place_of_origin Therapeutic classification Has_certificate_holder Certificate holder TradeName+Route+Form is_trade_equiv_of Property : Hong Kong registration Has_active_ingredient Property : allergy check flag Property : Generic product indicator Property : Dose form level extra (subcategory="base IS_A Base Ingredient ingredient"] ingredient") Editorial Guide on Hong Kong Clinical Terminology Table – Drugs (Medication Terminology Table) Has_Allergen_group ingredient" or "base ingredient"] Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDICES
Data tables contained in these Appendices may not be definitive. New entries may be
added when required.
Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX A – CAPITALISATION 6.1.1 Capitalisation Rules Description
The first character of a description should be in lower case or an integer, applicable to all concept types including the Fully Specified Names, Preferred Terms, Synonyms or other descriptions, unless otherwise specified in as exceptions. Trade Names and where trade name appears in other descendent trade concepts will have each word in the name expressed as title case, including the dose form, where it appears as part of the trade name or its suffix. Each word in a hyphenated name will be expressed as title case (e.g. Enervon-C Plus) unique brand specific casing will be preserved as of that given by the manufacturers Articles and conjunctions such as "the", "and", and "with" will be in lower case Certain words, such as "plus" may be either in upper case or lower, depending on their use Full proper nouns will be expressed (e.g. Bacillus Calmette and Guerin) Abbreviated descriptions such as "BCG" would be maintained as the alias name, where applicable. Roman numerals will always be expressed in upper case (e.g. factor VIII, antithrombin III) Chemical elements will be expressed in upper case (e.g. for carbon - "C"), or mixture of upper and lower case (e.g. sodium - "Na") as it is specified by the International Union of Pure and Applied Chemistry (IUPAC) convention. Single letters following a substance name will be expressed in upper case (e.g. vitamin C, amphotericin B, hepatitis B) Scientific names used to describe an organism will be expressed in full names and upper or lower case according to convention (e.g. Haemophilus influenzae, Streptococcus aureus) Organic substance names Each name will be expressed in lower case and will have any digits or single letters preceded and followed immediately by a hyphen (e.g. methyl-2-methoxy-3-pyrazine) Chemical ring position will always be expressed in lower case (e.g. para-dicholorobenzene) Isomeric prefixes D, L, S, R, E or Z will be indicated using a capital letter followed by a hyphen. The name entity itself will be entirely in lower case (see above) (e.g. N-acetylcysteine, D-alpha tocopherol). The isomeric planar rotation (chirality) should be indicated in capital letters. Greek symbols will be expressed as the English spelling of the word, rather than using traditional Greek symbol (e.g. alpha for "α", beta for "β", Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) gamma for "γ") Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX B – INGREDIENT NAMING CONVENTIONS 6.2.1 The Ingredient Naming Conventions Description
As described in previous sections, the FSN and PT of a Virtual Therapeutic Moiety (VTM) will be composed of the preferred terms of its active ingredient(s), including the salt. It is considered that despite the physiological salt (or the modified form) does not materially affect the use of a compound, the name will however be represented with the salt regardless but in two different ways: In VTMs where a product's strength is expressed in terms of the whole compound (i.e. including the salt), the ingredient should be have the entire compound name as the preferred term (e.g. "lithium carbonate") If the product strength is expressed in terms of the base ingredient (i.e. excluding the salt), then the ingredient description should be expressed such that the base ingredient is expressed with its salt or ester contained within a bracket (e.g. "amoxicillin (as trihydrate)") The active ingredient names will be derived from the International Non-proprietary Names (INN), followed by other approved or clinically intuitive names. In cases where the drug name enlisted in the Poisons List Regulations (Cap 138B) differs from the recommended INN, the name used in the Poisons List Regulations would be the preferred description. Ingredients Ending in "-ate": Ingredients that end in "-ate" when available as a salt, shall be changed so that the base is represented by ending in "-ic acid" where appropriate. The current edition of Martindale : The Complete Drug Reference will be the reference source. Clinically Significant Portion of Ingredient Name: Ingredients shall have the order of their name changed where necessary, so that the clinically significant part of the salt name is represented first (e.g. Ingredient name "calcium folinate" renamed to "folinate calcium". Ingredient Minus Base Name: Sometimes "IngredientMinusBase" has been changed in order for the expression to make more sense in the context in which it is used. In these cases, IngredientMinusBase does not equal the salt component of the name minus the base component of the name, and is represented by a more intuitive name. This is often the case with modified salts, or salts where the base ingredient name has been modified as in: Ingredient name " Insulins : ??? Name for insulin will be modified to show the type of insulin as follows: Insulin Aspart / Insulin aspart protamine / insulin detemir / insulin glargine / insulin lispro / insulin lispro protamine / insulin isophane bovine / insulin isophane human / insulin neutral bovine / insulin neutral human Virtual Medicinal Product Preferred Term Sequence of Active Ingredients: <this is a list of products where the sequence of ingredients is not alphabetical. These are exceptions based on: Clinical practice, one or more of the ingredients has no inherent action in its own right, or local Page 100 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) anaesthetic agents in all topical preparations, including those for oral/buccal use, followed by all other ingredients in alphabetical order.> For vaccine products, the organisms names should start with lower cases, and for multi-ingredient vaccines, the names be separated by a "+" sign. The names need not be sorted by any orders, but subject to editorial decision based on its clinical significance and its common use in current practice. note: the product strength of such items, which have the order of the active ingredients rearranged by this exception rule, should also be rearranged in the same order, so that the strengths are in the same order of the active ingredients. Special properties of a substance, or in the case of vaccine products the organism, this information should follow the organism/substance name, separated by a <Space>. In cases where there is more than one special properties, each of these would be separated by an unbreakable space between them. (e.g. diphtheria + tetanus + pertussis acelluar). Special property of a group of ingredients should be expressed after a comma (","). If a property that is a characteristic of the entire vaccine formulation, then such information should be added before the word vaccine. (e.g. where the special properties (e.g. conjugated, adsorbed) were used to describe the physical pharmaceutical formulation, these information need not be included as part of the VTM's preferred term. Information that is related to individual component's properties (such as split virion, attenuated, inactivated) should be included as part of the VMT's PT; taking reference to the names given by the manufacturer, and only clinical significant information would be added. Products with more than 2 ingredients: All the ingredients should be listed EXCEPTION: influenza virus vaccines – the fully specified names will be maintained as specified above; the preferred term will be in expressed as "influenza virus vaccine". Please refer to chapter 6.12.5 for details Referring to rule -APP-ING-8 above, VMP and AMP for which the sequence of their active ingredients should not be alphabetical in the naming - clinical significance of the ingredient in the medicinal compound; - one or more ingredients has no inherent action in its own right; - local anaesthetic agents are listed in all topical preparations, including those for oral/buccal use, followed by all other ingredients in a logical order based on editorial team's discretion, based on the above editorial principles; - this rule applies to all naming of all concepts within where ingredients Page 101 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) should be listed in the generic drug name. For compound preparations that have product strength expressed in terms of the total amount of therapeutic activity (e.g. elemental iron, elemental calcium), the ingredient(s) listed should preferably be expressed in terms of the amount of the whole compound (i.e. the salt) where available 6.2.2 Clinically Significant Portion of Ingredient Name [5]
Ingredients will have the order of their name changed where necessary, so that the clinically significant part of the salt name is expressed first. The table below shows some of the example where the ingredient name is arranged to display the clinically significant portion: Ingredient name
HK ingredient name
calcium folinate
folinate calcium disodium etidronate
etidronate disodium disodium pamidronate
pamidronate disodium sodium cromoglycate
cromoglycate sodium sodium fusidate
sodium valproate
valproate sodium sodium alendronate
alendronate sodium sodium citrate
dipotassium clorazepate
clorazepate dipotassium disodium clodronate
clodronate disodium sodium docusate
silver sulfadiazine
sulfadiazine silver activated charcoal
charcoal-activated 6.2.3 Waters of Hydration Waters of hydration shall be expressed for each ingredient where hydration is present. Where an ingredient is found to be anhydrous, this shall not be expressed. Lack of an expression of hydration assumes the ingredient to be anhydrous. Where a salt is deemed to be clinically significant or clinically relevant, then any associated waters of hydration are also deemed to be significant or relevant. Examples (FSNs): VTM: ondansetron (as hydrochloride dihydrate) Page 102 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) VTM: ibandronic acid (as ibandronate sodium monohydrate) Page 103 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Insulin products shall be represented in a way that the word "insulin" should appear first in the VTMs. The source of origin of insulin should be specified in the VTM descriptions and concepts (e.g. human, porcine, and bovine) except for those insulin produced as human analogs by recombinant DNA technology. (refer to Appendix 6.2.13 for detailed information on the expression rules of insulin products). Examples of human insulin analog products include (FSNs): Insulin aspart Insulin lispro Insulin detemir Insulin glargine For other insulin preparations the sources of origin will have to be included, examples are (FSNs): Insulin neutral human Insulin isophane human Insulin zinc suspension (soluble) bovine Insulin protamine zinc bovine Page 104 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX C – STRENGTH EXPRESSIONS [9] 6.3.1 General Strength Expression Rules Description
The strength units will be consistent with the unit of measure reference set The strength of an active ingredient should be expressed by a number between 1 and 999 metric units For power for injections, the strength would be expressed in terms of the total amount of the active drug. Where there may be information provided as to the final volume after reconstitution in accordance to the product literature, the volume should be documented (currently in the remarks box) but this information would not be taken into the creation of the VMP's preferred term. VMP and AMP for products where the product contains a single ingredient, the strength of such products should follow the dose form of the description, hence the following syntax should apply: "ingredient name" "route" "doseform" "strength" e.g. paracetamol oral tablet 500 mg For naming the FSN and PT of VMP and AMP for multi-ingredient
products, the strength of each of the component should be appended after
each of the individual ingredient component, hence the following syntax
should apply:
"ingredient1" "strength1" + "ingredient2" "strength2" + "ingredient3"
"strength3" "route "doseform"
e.g. amlodipine (as besilate) 5 mg + valsartan 80 mg oral tablet
This rule is also applicable to vaccine products where the same virus name
may be used repeatedly in the VTM (but of different strains)
e.g. for the vaccine with VTM:
"diphtheria toxoid vaccine + tetanus toxoid vaccine + Bordetella pertussis,
acellular pertussis toxoid vaccine + Bordetella pertussis, filamentous
haemagglutinin vaccine + poliomyelitis virus type 1 inactivated vaccine +
poliomyelitis virus type 2 inactivated vaccine + poliomyelitis virus type 3
inactivated vaccine"
Each component should have their strength expressed immediately after
the component description, i.e.:
"diphtheria toxoid vaccine minimum 30 international unit / 0.5 mL +
tetanus toxoid vaccine minimum 40 international unit / 0.5 mL +
Bordetella pertussis, acellular pertussis toxoid vaccine minimum 25
microgram / 0.5 mL + Bordetella pertussis, filamentous haemagglutinin
vaccine minimum 25 microgram / 0.5 mL + poliomyelitis virus type 1
inactivated vaccine minimum 40 D antigen unit / 0.5 mL + poliomyelitis
virus type 2 inactivated vaccine minimum 8 D antigen unit / 0.5 mL +
poliomyelitis virus type 3 inactivated vaccine minimum 32 D antigen unit
/ 0.5 mL intramuscular prefilled syringe"
Page 105 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Description
For naming the shortname descriptions of VMP and AMP for multi-
ingredient products, the strength of each component should be appended
after each of the individual component, hence the following syntax should
apply:
"shortname1" "strength1" + "shortname2" "strength2" "route" "doseform"
In cases where the ingredient components are combined into a single
description but with a varying amount, the strength should again but
expressed by the shortname description, and each strength value should be
separated by a comma (","), then followed by a common strength unit, i.e.:
"shortname" "strengthvalue1 , strengthvalue2 , strengthvalue3" "strength
unit" "route" "doseform", for example:
diphtheria toxoid 30 international unit / 0.5 mL + tetanus toxoid 40
international unit / 0.5 mL + pertussis acellular 8 , 25 , 25 microgram / 0.5
mL vaccine intramuscular prefilled syringe
For liquid dosage form, the strength would be expressed as the amount of active ingredients per unit volume. i.e. 100 mg / 5 mL In multi-ingredient products, as each of the ingredient component would be followed by its strength, hence: "ingredient1" "strengthvalue1 strength unit1" / "volumevalue1 volumeunit1" + "ingredient2" "strengthvalue2 strength unit2" / "volumevalue2 volumeunit2" "route" "doseform" For example: codeine phosphate 9 mg / 5 mL + ephedrine hydrochloride 6 mg / 5 mL + promethazine hydrochloride 3.6 mg / 5 mL oral syrup Exception to the strength expression rules for multiple ingredient products: Multi- ingredient product with combined-strength expression In normal circumstances for naming the FSN and PT of VMP and AMP for multi-ingredient products, the strength of each of the component should be appended after each of the individual ingredient component; hence the following syntax should apply: "ingredient1" "strength1" + "ingredient2" "strength2" + "ingredient3" "strength3" "route "dose form" e.g. VMP: amlodipine (as besilate) 5 mg + valsartan 80 mg oral tablet However in some exceptions the combined strength of all ingredients is of more clinically significant values because the combined strength is used during prescribing, with the fact that the strengths and strength ratios of the ingredients are standardized for these items. Hence for these multi-ingredient products the combined strength is used as strength and appended as below (similar to single-ingredient products): "ingredient1" + "ingredient2" + "ingredient3" "route" "dose form" "strength" e.g. VTM: amoxicillin (as trihydrate) + clavulanic acid (as potassium clavulanate) VMP: amoxicillin (as trihydrate) + clavulanic acid (as potassium clavulanate) oral tablet 375 mg Page 106 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Description
AMP: Augmentin (amoxicillin (as trihydrate) + clavulanic acid (as potassium clavulanate)) oral tablet 375 mg where the ingredients for this product are amoxicillin (as trihydrate) 250 mg and clavulanic acid (as potassium clavulanate) 125 mg If the number of units is less than 1, the next lower unit level should be used (e.g. 500 micrograms should be used in preference to 0.5 mg); If the number of units is equal to or greater than 1000, the next higher unit level should be used (e.g. 2 g should be used in preference to 2000 mg). Therefore the units of strength may vary within a single products. e.g. Ceftriaxone may have powder for injection strengths of 500mg, 1 g and 2 g. exception: non-metric units such as CCID50 or TCID50 where it is practically not possible convert. Where the trade name or suffix of a product implies a strength unit, this should be disregarded in the strength expression of the product, and the above rule applies. Exceptions of the above: safety considerations will be taken into account when converting units. If dose titration is likely to occur across a range of products, then strength units for the product group will be reviewed on an individual basis, especially if titration involves the use of more than one strength unit, with the following exceptions: ??? Strengths of ingredients less than 1 microgram will be reviewed on an individual basis to ensure the represented strength reflects its use in clinical practice (e.g. alfacalcidol is expressed in 0.25 micrograms not 250 nanograms) Large volume liquids such as oral solutions, parenteral infusions, irrigation fluids, haemodialysis solutions, peritoneal solutions will not be converted to "Litres" and will always be shown in millilitres ("mL") Where the volume is less than 1 millilitre it will not be converted (as current clinical practice these values will not be expressed as microlitres) Where the molar value is less than 1 micromole it will not be converted (as current clinical clinical practice these values will not be expressed as nanomoles) Where the unit of measure in an index of reactivity (IR) with a value less than 1, it will not be converted (as in current clinical practice these values cannot be converted) A space should be inserted between the strength value and strength unit. This space must be a non-breaking space to ensure that the strength value and strength unit expressions are always kept together Strength units should always be expressed as singular regardless of the strength value. The percentage strength will not be qualified with the appropriate w/w or w/v A strength expression is mandatory unless otherwise defined as an exception (e.g. Aqueous cream) Page 107 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Description
If the strength value or volume of a product is expressed in a range, the lower numerical value should be stated, followed by the word "to" and then the upper numerical value and the unit that is common to express the two values. If the strength value or volume of a product is expressed with a lower limit only (i.e. no less than, contains equal to or greater than, more than) the strength or volume should be expressed with the word "minimum" followed by the strength or volume (e.g. rubella live vaccine attenuated vaccine minimum 1000 unit injection For vaccine products, if the product is supplied as multi-dose vial and there exists more than one pack sizes (i.e. differing number of doses contained in the multi-dose vial), the strength should be expressed in "dose value" / "dose unit volume", e.g. 0.25 mg / 0.5 mL An unbreakable <space> should be inserted before and after a separator
symbol.
Strength expression for a liquid dosage form: 400 mg / 5 mL
Expression of special properties that should be applied to multi-ingredients
in a product with multi-component:
If the strength unit is international unit, the full expression "international unit" should be used. All rules in Appendix "Strength Expression Rules for Specific Dose Forms" apply. In order to maintain VTM for those fluids and electrolytes without the strength (e.g. for the VMP "sodium chloride 5 % parenteral solution for infusion", its upstream parent VTM should be "sodium chloride" (NOT sodium chloride 5 %); therefore for entering the "VTM" value, "sodium chloride" should be entered, strength should be maintained as "5 %"; since under our current rule for single ingredient products, the strength will only be appended at the end of the product (VMP and AMP) description - for "IV fluids and eye/ear/nasal drops which contains electrolytes or salts, the strength needs to be appended after the "VTM" such that "sodium chloride 5 % parenteral solution for infusion" or "sodium chloride 0.9 % eye drops" can be more accurately expressed. The same principle should be applied to trade names of generic products where the trade name would be expressed as "sodium chloride (B Braun)" (HK-28240) and the resulting AMP should be expressed as "sodium chloride 5 % (B Braun) parenteral solution for infusion". Page 108 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 6.3.2 Strength Expression Rules for Specific Dosage Forms [6][7][8]
The following table summarises the editorial rules and exceptions for displaying strengths in various pharmaceutical dosage forms. Dose forms
Solid unit dose forms
The strength will be expressed as the amount per unit dose form. For example: Examples:
Tablet, buccal tablet, chewable tablet,
amoxicillin (as trihydrate) oral capsule 500 mg dispersible tablet, effervescent tablet,
allopurinol oral tablet 100 mg modified-release tablet, soluble tablet,
Baclofen oral tablet 10 mg sublingual tablet, capsule, modified-release
azithromycin (as dehydrate) oral tablet 250 mg capsule, pessary, suppository, lozenge, pastille,
chewing gum, oral lyophilisate, etc.
Liquid unit dose forms –
The strength will be expressed as the total injections and intravenous infusions
amount of active drug present, in terms of the following in the unit dose volume, for example: Examples:
gentamcin sulfate parenteral injection 80 mg / 2 ampoule, vial, pre-filled syringe, cartridge,
bottle, bag, etc
Exception: For dose forms that do not have an associated specific strength. water for injection will not have a specified strength, therefore should be expressed as: water for injection ampoules 10 mL Liquid unit dose forms –
The strength will be expressed as the amount of active drug per mL This method will be used for insulins and other multi-dose injections
identified multi-dose injection dose forms where the intention is that only a proportion of the total dispensed quantity will be administered at any one time, for example: insulin aspart subcutaneous injection 100 international unit / mL Liquid unit dose forms –
The strength will be expressed as a percentage, large volume injections for large volume
infusion fluids such as electrolyte
sodium chloride 0.9 % intravenous infusion bag replacement, nutritional therapy, plasma
substitutes, etc.
Liquid unit dose forms –
The strength will be expressed as percentage. Depending upon the product this can be % w/w, Multi-dose or single –dose eye / ear / nasal
% w/v, % v/w, or % v/v. Occasional the strength may be expressed as the amount per mL where it is more clinical relevant. Mass per mL – mg / mL, microgram / mL Activity – unit / mL Exception: Page 109 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Dose forms
Rules
Some products such as physiological saline may
have their strength expressed as part of the VTM
(i.e. sodium chloride 0.9 % (product)); therefore
do not require to express the strength.
Examples:
ofloxacin eye drops 3 mg / 1 mL
diclofenac sodium eye drops 0.1 %
prednisolone sodium phosphate eye drops
(minims) 0.5 %
Tarivid (ofloxacin) ear drops 3 mg / 1 mL
Garamycin (gentamicin) eye and ear drops 0.3 %
codeine hydrochloride eye and nasal drops 5 %
Otrivin (xylometazoline hydrochloride) nasal
drops 0.1 %
Restasis (ciclosporin) ophthalmic emulsion 0.05
%
Liquid unit dose forms –
The strength will be expressed as the total amount of active drug per total volume in a single dose unit; the amount may be expressed as sachets of liquids, nebulizer liquid unit dose
weight or units of the active drug, for example: Weight: mg, microgram, g, nanogram, or Number of units – international units, units, million units budesonide inhalation nebulising solution 1 mg / 2 mL dornase alfa inhalation solution 1 mg / 1 mL diazepam rectal solution 10 mg / 2.5 mL Continuous solid unit dose forms
The strength will be expressed as the weight of the active drug per container. In some cases, the Examples:
strength may be expressed as a percentage, in granules, powder
which case the weight of the active drug will be expressed together with the percentage. For example: testosterone base oral powder 25 g / sachet biotin oral powder 10 mg / sachet Biosorb (maize starch sterilisable) oral powder 1.5 g / packet sterculia granules 7 g / sachet Continuous semi-solid preparations
The strength will be expressed as percentage. Depending upon the product this can be % w/w, Examples:
% w/v, % v/w, or % v/v. Occasional the strength cream, gel, ointment
may be expressed as the amount per gram where it is more clinical relevant. Mass per gram – mg / g, microgram / g Activity – unit / g Page 110 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Dose forms
Exception: Products such as aqueous cream do not require strength to be expressed. Examples: acyclovir topical cream 5 % 2 g acyclovir ophthalmic ointment 3 % 4.5 g diclofenac sodium topical gel 1 % 20 g betamethasone (as dipropionate) topical cream 0.05 % 15 g nystatin topical cream 100,000 unit / g tacrolimus topical ointment 0.1 % 30 g Continuous liquid preparations –
The strength will be expressed as the amount of For oral use
active drug per a stated unit volume, as it is represented on the product package / product Example:
solutions, suspensions, emulsions, liquids
Examples: amoxicillin oral suspension 125 mg / 5 mL azithromycin oral suspension 200 mg / 5 mL erythromycin (as ethylsuccinate) oral syrup 125 mg / 5 mL where a powder for oral suspension is labeled in terms of the reconstituted form, the strength will be represented as the amount of active drug in the reconstituted dose volume, for example: amoxicillin oral powder for suspension 250 mg / 5 mL Continuous solid preparations (non-unit dose
The strength will be expressed as a percentage form) –
but may be expressed as a weight per weight or granules, powder
weight per volume, for example: silver nitrate caustic pencil 95 % Metamucil (psyllium hydrophilic mucilloid fiber) oral powder 538 mg / g Page 111 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Dose forms
The strength will be expressed as the amount of (transdermal patches)
active drug released over a stated period of time. The amount will usually be a weight (mg, microgram) and the time will depend on the clinical use of the product as specified on the product information. In general, a patch used for pain relief will often express the strength as the amount of drug released per hour, whereas a HRT patch is usually over 24 hours. Some nicotine patches are designed to be worn during day-time and for these preparations, express the strength over 16 hour period. For example: estradiol transdermal patch 25 microgram / 24 hr estradiol transdermal patch 100 microgram / 100 hr fentanyl transderaml patch 50 microgram / hr glyceryl trinitrate transdermal sustained-release patch 10 mg / 24 hr hyoscine hydrobromide transdermal patch 1 mg / 72 hr nicotine transdermal patch 10 mg / 16 hr rotigotine transdermal patch 4 mg / 24 hr Inhalers and sprays
The strength will be expressed as the amount of drug per actuation. The amount will usually be Example:
expressed as the weight of active drug, for metered-dose inhalers, sprays, dry powder
inhalers, nasal spray, sublingual spray
beclomethasone dipropionate inhaler (CFC-free) 50 microgram / actuation beclomethasone diproionate breath actuated inhaler (CFC-free) 250 microgram / actuation Pre-filled syringes / implants / vaginal rings /
The strength will be expressed as the amount of intra-uterine devices
active drug per device or as the amount released over a stated period of time (i.e. mass / x hr), for example: goserelin (as acetate) implant pre-filled syringe 10.8 mg Mirena (levonorgestrel) intra-uterine system 20 microgram / 24 hr Dry powder injections
The strength will be expressed as the amount of (For products with unknown dilution volume) active drug per vial. This will usually be a weight
but may be expressed as a number of units Example: Amoxicillin parenteral powder for solution for injection 500 mg / vial Page 112 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Dose forms
Dry powder injections
The strength will be expressed as the amount of (For products with final diluted volume as
active drug per final reconstituted volume. This recommended by manufacturer)
is the volume after reconstitution of the powder as recommended by the manufacturer; this does not include any further dilution or manipulation of the volume. This will usually be a weight but may be expressed as a number of units. Example: Oxaliplatin parenteral powder for solution for injection 100 mg / 16.7 mL Page 113 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 6.3.3 Dual Representation Dual representation of strength will be considered where clinical relevant. For example:  Insulin products – o For multiple ingredient preparations, the combined overall strength (units per mL) of the multi-ingredient insulin preparations remain clinically significant as the ratios of the different insulin ingredients are standardized and the drugs are prescribed in terms of the combined strength; whereas the ratio of the ingredients remains a clinically important information. Therefore the strength expression for these multi-ingredient insulin preparations is modified to suit both purposes. (Refer to Chapter 6.12.3 for detailed strength expression rule on insulin products.) parenteral solutions containing electrolytes – the number of mmol of electrolytes will be stated as well as the amount of the salt (where possible); eye drops, creams and ointments – the percentage of active ingredient may be stated as well as the amount of active ingredient per unit measure. Page 114 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX D – ROUTE OF ADMINSTRATION [9][10][11][12] 6.4.1 The HKMTT routes will be referencing, and with their definitions extracted from the following standard terminologies:  The Compendium of Pharmaceutical Products, Department of Health, HKSAR. UK NHS dm+d "Virtual Medicinal Product Route (List D) – the VMP route consists of European Directorate for the Quality of Medicines & Healthcare (EDQM) Standard terms. Australian TGA Approved Terminology for Medicines – Chapter 2 : Australian Approved Terms for Use in the Completion of Applications for the Registration or listing of Therapeutic Goods, section 6 – Routes of Administration US Food and Drug Administration (FDA) Centre for Drug Evaluation and Research (CDER) Data Standard Manual (Data Element #C-DRG-00301 Route of Administration) Table - MTT Route List
Route of Administration
Definition
Buccal pertaining to the cheek cavity Dental Pertaining to the teeth or a tooth Administered into the ear ear, eye and nasal
Administered into the eye or ear or in or within the nose Administered via an endotracheal tube epidural
Administered to the outside, upon, or over the dura mater epidural and infiltration
Administered to the outside, upon, or over the dura mater epidural and infiltration Administered to the outside, upon, or over the dura mater, or
and intrathecal
introduced in the inside of, or into, the trachea epilesional
Introduced directly to a lesion external
Administration or use for outside of the body. Administered into the eye eye and ear
Administered into the eye or ear eye and ear and nasal
Administered into the eye, ear or in or within the nose eye and nasal
Administered into the eye or in or within the nose Administration of a medicinal product to the stomach Clearance of the blood by means of a semi-permeable membrane Clearance of the blood by the use of positive pressure across a semi permeable membrane and the use of replacement fluid Infiltration is the diffusion or accumulation of medicinal substances in a tissue or skin. Page 115 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Route of Administration
Definition
Taking into the lungs by breathing through the nasal or oral inhalation
respiratory route for local or systemic effect Dropping of a liquid on or into a body part. Within an artery or arteries Within a joint or inside the cavity of a joint Administered into or via an indwelling catheter Within the tissues of the corpus cavernosum penis, but not including urethral administration or application to the skin Administration of a medicinal product into the cervix uteri Within or into a cistern intradermal
Within the dermis Into or within the fibrocartilage plates separating the articulating intradiscal
surfaces of bone Administration within the epidermis Introduced directly into a localised lesion Within or into the substance of a muscle intranasal
Administered into the nose intraocular
Within the eyeball Within the cavity of the peritoneum Within the pleura or the cavity of the pleura Administered through the theca of the spinal cord into the intrathecal
subarachnoid space, or within the spinal meninges Introduced in the inside of, or into, the trachea Within or inside the uterus Administered into the blood vessels intravenous
Within or into a vein Within the urinary bladder, or within any other bladder Within the vitreous cavity of the eye Applied to a mucous membrane Administered into or within the nose ophthalmic
Administered into the eye Taken through the mouth into the gastrointestinal system Page 116 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Route of Administration
Definition
Taken through the mouth into the gastrointestinal system, or oral and intravenous
administered into a vein Taken through the mouth into the gastrointestinal system, or oral and parenteral
administered parenterally Taken through the mouth into the gastrointestinal system, or inserted oral and rectal
into the rectum Applied in or within the mouth cavity for a local effect. Not meant to oral application
be swallowed. e.g. Mouth lotion/gel or mouth gargles, etc. Administration of a medicinal product to the oral cavity to obtain a oromucosal
local or systemic effect. Oral use is excluded. Administration by means other than the gastrointestinal tract; usually parenteral
involves piercing of skin or mucous membrane. Administration by means other than the gastrointestinal tract; usually involves piercing of skin or mucous membrane, or by taking into the parenteral and inhalation
lungs by breathing through the nasal or oral respiratory route for local or systemic effect Administered in the cellular and fibrous tissues surrounding a joint peritoneal
Within the cavity of the peritoneum Materials used for manufacturing, processing or repacking. Not for raw materials
Through the rectum Administered beneath the conjunctiva of the eye Administered beneath the skin sublingual
Administered beneath the tongue for a systemic effect submucosal
Administered or introduced beneath a mucous membrane Applied to a certain area of the skin for a localised effect Applied to the skin for a systemic effect by the diffusion or transdermal
continuous absorption of the active ingredient through the skin urethral
Administered through the urethra Applied into the vagina Buccal pertaining to the cheek cavity Dental Pertaining to the teeth or a tooth Administered into the ear ear, eye and nasal
Administered into the eye or ear or in or within the nose Administered via an endotracheal tube epidural
Administered to the outside, upon, or over the dura mater epidural and infiltration
Administered to the outside, upon, or over the dura mater Page 117 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Route of Administration
Definition
epidural and infiltration Administered to the outside, upon, or over the dura mater, or
and intrathecal
introduced in the inside of, or into, the trachea epilesional
Introduced directly to a lesion external
Administration or use for outside of the body. Administered into the eye eye and ear
Administered into the eye or ear eye and ear and nasal
Administered into the eye, ear or in or within the nose eye and nasal
Administered into the eye or in or within the nose Administration of a medicinal product to the stomach Clearance of the blood by means of a semi-permeable membrane Clearance of the blood by the use of positive pressure across a semi permeable membrane and the use of replacement fluid Infiltration is the diffusion or accumulation of medicinal substances in a tissue or skin. Taking into the lungs by breathing through the nasal or oral inhalation
respiratory route for local or systemic effect Dropping of a liquid on or into a body part. Within an artery or arteries Within a joint or inside the cavity of a joint Administered into or via an indwelling catheter Within the tissues of the corpus cavernosum penis, but not including urethral administration or application to the skin Administration of a medicinal product into the cervix uteri Within or into a cistern intradermal
Within the dermis Into or within the fibrocartilage plates separating the articulating intradiscal
surfaces of bone Administration within the epidermis Introduced directly into a localised lesion Within or into the substance of a muscle intranasal
Administered into the nose intraocular
Within the eyeball Within the cavity of the peritoneum Within the pleura or the cavity of the pleura Page 118 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Route of Administration
Definition
Administered through the theca of the spinal cord into the intrathecal
subarachnoid space, or within the spinal meninges Introduced in the inside of, or into, the trachea Within or inside the uterus Administered into the blood vessels intravenous
Within or into a vein Within the urinary bladder, or within any other bladder Within the vitreous cavity of the eye Applied to a mucous membrane Administered into or within the nose ophthalmic
Administered into the eye Taken through the mouth into the gastrointestinal system Taken through the mouth into the gastrointestinal system, or oral and intravenous
administered into a vein Taken through the mouth into the gastrointestinal system, or oral and parenteral
administered parenterally Taken through the mouth into the gastrointestinal system, or inserted oral and rectal
into the rectum Applied in or within the mouth cavity for a local effect. Not meant to oral application
be swallowed. e.g. Mouth lotion/gel or mouth gargles, etc. Administration of a medicinal product to the oral cavity to obtain a oromucosal
local or systemic effect. Oral use is excluded. Administration by means other than the gastrointestinal tract; usually parenteral
involves piercing of skin or mucous membrane. Administration by means other than the gastrointestinal tract; usually involves piercing of skin or mucous membrane, or by taking into the parenteral and inhalation
lungs by breathing through the nasal or oral respiratory route for local or systemic effect Administered in the cellular and fibrous tissues surrounding a joint peritoneal
Within the cavity of the peritoneum Materials used for manufacturing, processing or repacking. Not for raw materials
Through the rectum Administered beneath the conjunctiva of the eye Administered beneath the skin Page 119 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Route of Administration
Definition
sublingual
Administered beneath the tongue for a systemic effect submucosal
Administered or introduced beneath a mucous membrane Applied to a certain area of the skin for a localised effect Applied to the skin for a systemic effect by the diffusion or transdermal
continuous absorption of the active ingredient through the skin urethral
Administered through the urethra Applied into the vagina *parenteral includes intra-arterial, intra-articular, intracavernosal, intracervical, intracisternal, intradermal, intradiscal, intraepidermal, intralesional, intramuscular, intrapleural, intrathecal, intratracheal, intravenous, intravesical, intravitreal. Page 120 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX E – DOSE FORM [13][14][15][16] 6.5.1 The HKMTT dose forms will be referencing, and with their definitions extracted from the following standard terminologies:  The Compendium of Pharmaceutical Products, Department of Health, HKSAR UK NHS dm+d "Virtual Medicinal Product Form (List C) – the VMP form consists of European Directorate for the Quality of Medicines & Healthcare (EDQM) Standard terms. dm+d has made amendments to minimize multiplicity of terms or excluded terms where the pharmaceutical forms do not reflect the prescribed form. Australian NEHTA AMT Appendix VII – Form (section 10.7) – originally derived from the TGA Approved Dosage Forms, with additional forms added to allow specification of subtypes. US Food and Drug Administration (FDA) Centre for Drug Evaluation and Research (CDER) Data Standard Manual (Data Element #C-DRG-00201 Dosage Form) 6.5.2 The HKMTT Dose Forms are listed in the table below. In most cases a dose form requires the combined use of a specified route to allow the true pharmaceutical form be defined. For example, a tablet dosage form can be used via the buccal or oral route but the true prescribable pharmaceutical form would be "buccal tablet" and "oral tablet" respectively. In HKMTT, a route will be assigned to the AMPs, VMPs, VTM+R+F and TN+R+F, hence there need not be a route specified in the dosage form – MTT will assign dose forms according to the route specified. 6.5.3 For example, in the case of a tablet formulation that is intended to be ingested, the route will be "oral" and dose form will be "tablet", hence the route-dose form
combination will become "oral tablet" (e.g. paracetamol oral tablet 500 mg).
Table - MTT Dose Form List
Dose Form
Definition
CAPSULES
A preparation containing one or more active ingredients dispersible tablet in a gum base, to be chewed or dispersed to produce a solution for oral administration. A solid preparation with hard or soft shells of various shapes and capacities, usually containing a single dose of active ingredient(s). The capsule shells are made of gelatin or other substance. The contents of capsules may be solid, liquid or of a paste-like consistency. For oral administration, the shell is attacked by the digestive fluids and the contents are released. Capsules can also be formulated for use via a variety of administration Page 121 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) routes (e.g. oromucosal, rectal, vaginal) to obtain a systemic or local effect for protective, therapeutic or prophylactic purposes. gastro-resistant Gastro-resistant (enteric coated) capsules are prepared in such a manner that the shell, or the pelletised contents are intended to resist the gastric fluid and to release their active ingredient(s) in the intestinal fluid. modified-release Modified-release capsules are prepared in such a manner that the contents or the shell or both contain special excipients or are prepared by a special process designed to modify the rate or the place at which the active ingredient(s) are released. A solid preparation containing one or more active ingredients, usually a measured quantity, with or without suitable diluents in a wide variety of sizes, shapes and surface markings prepared by moulding or compression for oral, sublingual or other use. A tablet with a palatable formulation designed to be chewed rather than swallowed whole. dispersible tablet A tablet which rapidly produces a uniform dispersion in water and is intended to be dispersed prior to administration. effervescent tablet A tablet generally containing acid substances and carbonates or bicarbonates which react rapidly in the presence of water to release carbon dioxide. It is intended to be dissolved or dispersed in water before administration. gastro-resistant Gastro-resistant tablets are delayed-release tablets that are intended to resist the gastric fluid and to release their active substance(s) in the intestinal fluid. Usually they are prepared from granules or particles already covered with a gastro-resistant coating or in certain cases by covering tablets with a gastro-resistant coating. modified-release A coated or uncoated tablet in which the rate or place of release of the active ingredients in the gastrointestinal tract has been modified. orodispersible tablet Tablet to be placed in the mouth where it disperses rapidly before swallowing. An uncoated tablet that is intended to be dissolved in water prior to administration. The solution produced may be slightly opalescent due to excipients used in the Page 122 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) manufacture of the tablet. GRANULES
A preparation of one or more active ingredients usually in the form of irregular particles 2mm to 4mm in diameter. Some granules are intended to be dissolved or dispersed in water before issuing or before taking; others are chewed or placed on the tongue and swallowed with a draught of water. Granules which evolve carbon dioxide when added to water. They are intended to be dissolved or dispersed in water before administration. gastro-resistant Gastro-resistant granules are delayed-release granules that are intended to resist the gastric fluid and to release the active substance(s) in the intestinal fluid. These properties are achieved by covering the granules with a gastro-resistant material (enteric-coated granules) or by other suitable means. modified-release Granules in which the rate or place of release of active ingredients in the gastrointestinal tract has been modified. effervescent powder Effervescent powders are presented as single-dose or multidose powders and generally contain acid substances and carbonates or hydrogen carbonates which react rapidly in the presence of water to release carbon dioxide. They are intended to be dissolved or dispersed in water before administration. Freeze dried, fast releasing preparation to be placed on the tongue, or alternatively to be dissolved in water before administration. A finely divided powder composed of, or containing one or more active ingredients for oral or nasogastric administration, generally with water. The dose is obtained either by measuring a volume of the powder or from an individual container e.g. sachet, paper tube or vial. BUCCAL AND THROAT
Tablet to be applied to the buccal cavity or to be sucked. Capsule to be applied to the buccal cavity or to be sucked. A preparation containing one or more active ingredients in a gum base, to be chewed and subsequently discarded. Page 123 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Gargle is an aqueous solution used for gargling. The process of gargling is intended to bring the liquid into intimate contact with membranous lining of the throat. The term also covers solid and liquid preparations which have to be dissolved or reconstituted or diluted using a suitable liquid diluent before use. irrigation solution buccal irrigation solution is a liquid intended for external application to the buccal cavity. A solid preparation, containing one or more active ingredients, usually in a flavoured base, which is intended to dissolve or disintegrate slowly in the mouth to effect a local action. An aqueous solution of one or more active ingredients intended, usually after dilution with warm water, for use in contact with the mucous membranes of the oral cavity, in some cases including gargling. A solid preparation containing one or more active ingredients incorporated in a mass of sweetened gum, glycerol, and gelatin base which is intended to be sucked. A compound containing one or more active ingredients used with a toothbrush for cleaning and polishing the teeth. A semi-solid preparation consisting of liquids gelled by means of suitable gelling agents. It is intended for use within the oral cavity. A solution of one or more active ingredients which has been extracted into an alcoholic base for use in the oral cavity. A preparation usually consisting of a solution, a suspension or an emulsion of one or more active ingredients in a suitable vehicle. Dental liquids are intended to be used within the oral cavity. A preparation usually consisting of a solution, a suspension or an emulsion of one or more active ingredients in a suitable vehicle. Oral drops are intended to be swallowed either undiluted or after dilution. multiple component [To be completed]
An oral paste is a semi-solid preparation that is much stiffer than ointments for application to the oral mucosa. It usually consists of finely ground insoluble powders dispersed in hydrocarbon or water-miscible bases. Page 124 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) A finely divided powder composed of, or containing, one or more active ingredients to be reconstituted in the oral cavity. A liquid preparation composed of or containing one or more active ingredients dissolved in a suitable vehicle. Dental strips are impregnated with an active substance intended for application inside the oral cavity. They are usually individually wrapped and sterile. A liquid preparation for application after dispersion with a spraying device, intended for administration within the oral cavity. sublingual
A liquid preparation for application after dispersion with a spraying device, intended for administration under the tongue. sublingual
An uncoated tablet designed to be placed under the tongue, where it is rapidly absorbed. It should not be swallowed whole. Ear drops are liquid single-dose or multidose preparations consisting of an aqueous or oily solution, suspension or emulsion intended for application to the external auditory meatus. A preparation intended to cleanse the skin or certain mucosal membranes or body cavities or canals. It is usually an aqueous solution with a pH within physiological limits. The term also covers solid and liquid preparations which have to be dissolved or reconstituted or diluted using a suitable liquid diluent before use. Spray is solution, emulsion or suspension of one or more active substances in liquids intended for spraying into body cavities or canals. The preparation is supplied in containers with atomising devices or in pressurised containers fitted with a suitable adapter and with or without a metering dose valve. A sterile solution, suspension or emulsion of one or more active ingredients intended for instillation into the conjunctival sac. ophthalmic
A semi-solid preparation usually consisting of a solution or dispersion in a suitable base, prepared with the aid of a suitable gelling agent, intended for application to the conjunctiva. irrigation solution Eye irrigation solution is a liquid intended for external application to the eye. Page 125 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) A sterile aqueous solution intended for use in washing or bathing the eye or for impregnating eye dressings. The term also covers solid and liquid preparations which have to be reconstituted or diluted using a suitable liquid diluent before use. A sterile semi-solid preparation of homogeneous appearance intended for application to the conjunctiva. It may contain one or more active ingredients dissolved or dispersed in a suitable base. intraocular
Intraocular injection is a liquid intended to be injection into the eye. intraocular
irrigation solution Intraocular irrigation solution is a liquid intended for external application to the eyeball. intraocular
powder and solvent A powder preparation composed of, or containing, active for solution for ingredients which when dispersed in a suitable manner, is intended to be administered as Intraocular irrigation solution. Ophthalmic
An ophthalmic emulsion is a sterile dispersion of an oily liquid in an aqueous liquid for instillation to the conjunctiva. Ophthalmic
Ophthalmic insert is a sterile, solid or semi-solid preparation of suitable size and shape, designed to be inserted in the conjunctival sac, to produce an ocular effect. It generally consists of a reservoir of active substance embedded in a matrix or bounded by a rate-controlling membrane. ophthalmic
Ophthalmic strips are impregnated with an active substance intended for local application. They are usually individually wrapped and sterile. An eye emulsion is a sterile dispersion of an oily liquid in an aqueous liquid for instillation to the conjunctiva. An eye suspension is a sterile suspension of active substance in an aqueous liquid for instillation to the conjunctiva. A liquid preparation for instillation into the nostrils by means of a dropper. Nasal ointment is a semi-solid preparation intended for nasal use, usually consisting of a solution or dispersion of one or more active ingredients in low proportions in a suitable base, usually non-aqueous. A powder preparation composed of, or containing, active ingredients which when dispersed in a suitable manner is intended to be self-administered by inhalation via the nasal route for local or systemic effect. It is usually inhaled in controlled amounts. Page 126 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) A liquid preparation composed of or containing one or more active ingredients dissolved in a suitable vehicle, intended for application to the nostrils. A liquid preparation for application after dispersion with a spraying device, intended for use via the nostrils. INTERNAL LIQUID
A preparation usually consisting of a solution, a suspension or an emulsion of one or more active ingredients in a suitable vehicle. Oral drops are intended to be swallowed either undiluted or after dilution. A clear, pleasantly flavoured, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use. A dispersion of an oily liquid in an aqueous liquid either of which may contain dissolved solids, in which the aqueous liquid forms the continuous phase. Solids may be suspended in the emulsion. Granules for oral suspensions are granules that may be dispersed to prepare oral liquids containing one or more active ingredients suspended in a suitable vehicle. Suspended solids may slowly separate on standing but are easily redispersed. gastroenteral liquid Gastroenteral liquids are administered via the enteral route (oral, nasogastric, PEG, jejenostomy etc.) used either to provide sole nutrition or to supplement other food intake. The term covers emulsions, suspensions, and solutions provided for this use case. A solution of one or more active ingredients which has been extracted into an alcoholic base. A preparation usually consisting of a solution, a suspension or an emulsion of one or more active ingredients in a suitable vehicle. Oral liquids are intended to be swallowed either undiluted or after dilution. A liquid preparation composed of a syrup base in which may be dispersed one or more active ingredients; intended for oral use. powder for solution A finely divided powder composed of, or containing, one or more active ingredients to be reconstituted in a suitable liquid for use as a liquid for oral administration. A finely divided powder composed of, or containing, one or more active ingredients to be reconstituted in a suitable liquid for use as a suspension for oral administration. A liquid preparation composed of or containing one or more active ingredients dissolved in a suitable vehicle. A concentrated solution of sugar in water to which one or more active ingredients may be added. Page 127 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Oral suspensions are oral liquids containing one or more active ingredients suspended in a suitable vehicle. Suspended solids may slowly separate on standing but are easily redispersed. INJECTIONS
parenteral*
A sterile solution which must be diluted with another sterile parenteral liquid in order to prepare an injection. concentrate for solution for injection and infusion parenteral*
A concentrate and solvent for suspension for injection is solvent for solution a sterile solution containing the active substances to be distributed in its final container with a specified volume of a specific sterile solvent. parenteral*
A sterile dispersion of an oily liquid in an aqueous liquid either of which may contain dissolved solids, in which the aqueous liquid forms the continuous phase. Solids may be suspended in the emulsion. parenteral*
Radiopharmaceutical is any medicinal product which, radiopharmaceutical when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose. A kit usually consists of a sterile injection and solvent in lyophilized and sterile form. parenteral*
powder for injection A sterile, solid substance to be reconstituted in an appropriate sterile liquid before injection. parenteral*
A powder for suspension for injection is a solid, sterile substance distributed in its final container and which, when shaken with the prescribed volume of a prescribed sterile liquid rapidly forms a uniform suspension. After suspension it conforms to the requirements for injections. Freeze-dried products for parenteral use are considered as powders for suspension for injection parenteral*
A sterile, clear liquid preparation containing one or more active ingredients dissolved in one or more suitable solvents. solution for injection and infusion parenteral*
A sterile liquid preparation containing one or more active ingredients dispersed as solid particles throughout a liquid phase in which the particles are not soluble. It may also contain dissolved active ingredients. parenteral*
powder and solvent A powder and solvent for suspension for injection is a for suspension for solid, sterile substance distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a suspension. After dissolution it complies with the Page 128 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) requirements for injections. Freeze-dried products for parenteral use are considered as powder and solvent for suspension for injection parenteral*
powder and solvent A powder and solvent for solution for injection is a solid, for solution for sterile substance distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a clear solution. After dissolution it complies with the requirements for injections. Freeze-dried products for parenteral use are considered as powder and solvent for solution for injection parenteral*
powder for solution A powder for solution for injection is a solid, sterile substance distributed in its final container and which, when shaken with the prescribed volume of a prescribed sterile liquid rapidly forms a clear solution. After dissolution it complies with the requirements for injections. parenteral*
powder and solvent A powder and solvent for concentrate for injection is a for concentrate for solid, sterile substance distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a suspension. After dissolution it must be further diluted with suitable diluents to prepare for an infusion fluid before injection. parenteral*
parenteral*
pre-filled syringe A prefilled syringe contains the exact dose for injection which allows the required dose to be delivered precisely. INFUSION
parenteral*
A sterile solution which must be diluted with another solution for infusion sterile parenteral liquid in order to prepare an infusion. parenteral*
A concentrate and solvent for solution for infusion is a solvent for solution sterile liquid distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a clear solution. After dissolution it complies with the requirements for infusions. parenteral*
A sterile solution which must be diluted with another sterile parenteral liquid in order to prepare an injection or parenteral*
solution for infusion A sterile injection designed to be infused parenterally into the body. parenteral*
A sterile solution to be injected or infused parenterally Page 129 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) parenteral*
A sterile suspension designed to be infused parenterally parenteral*
A sterile emulsion designed to be infused parenterally parenteral*
powder for solution A powder for solution for infusion is a solid, sterile substance distributed in its final container and which, when shaken with the prescribed volume of a prescribed sterile liquid rapidly forms a clear solution. After dissolution it complies with the requirements for infusions. parenteral*
A powder for suspension for infusion is a solid, sterile substance distributed in its final container and which, when shaken with the prescribed volume of a prescribed sterile liquid rapidly forms a suspension. After dissolution it complies with the requirements for infusions. parenteral*
powder and solvent A powder and solvent for solution for infusion is a solid, for solution for sterile substance distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a clear solution. After dissolution it complies with the requirements for infusions. parenteral*
powder and solvent A powder and solvent for suspension for infusion is a for suspension for solid, sterile substance distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a suspension. After dissolution it complies with the requirements for infusions. Powder and solvent A powder and solvent for concentrate for infusion is a for concentrate for solid, sterile substance distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a suspension. After dissolution it must be further diluted with suitable diluents to prepare for an infusion fluid before infusion. EXTERNAL
external
A strip or roll of cloth or other material that may be wound around a part of the body in a variety of ways to secure a dressing, maintain pressure over a compress, or immobilise a limb or other part of the body. external
Barrier contraceptive method that blocks the route of
sperm from fertilizing the eye.
external
[To be completed]
external
Sterile fabric material used to cover or protect wounds. Page 130 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) external
Irrigation solution A solution, usually sterile, of one or more active ingredients intended for flushing or instilling followed by drainage (including peritoneal dialysis) of wounds, operation cavities, the vagina, the urinary system, or serous cavities such as abdominal and pleural cavities. external
A packaged collection of related material. external
Liquid preparations are usually solutions, emulsions or suspensions containing one or more active substances in a suitable vehicle. They may, however, consist of liquid active substances used as such. The term also includes concentrates which have to be diluted with a suitable liquid before use. external
medicated plaster Medicated plasters are flexible preparations containing one or more active substances. They are intended to be applied to the skin. They are designed to maintain the active substance(s) in close contact with the skin such that these may be absorbed slowly or act as protective or keratolytic agents. external
Paste is a semi-solid preparation that is much stiffer than ointments. It usually consists of finely ground insoluble powders (at concentrations of 20% to 60%) dispersed in hydrocarbon or water-miscible bases. external
[To be completed]
external
A liquid preparation containing one or more active substances in a suitable vehicle. They may, however, consist of liquid active substances used as such. The term also includes concentrates which have to be diluted with a suitable liquid before use. external
solution for skin Solution for skin prick test is allergen product for cutaneous and transdermal diagnostic use. external
A solid preparation containing one or more active ingredients in stick form. external
A long narrow piece of solid material intended for use in testing, screening or assaying a biological substance. external
A liquid that is intended to be used as a cleansing agent for skin (include body wash, soap, bath oil, bath liquid etc.). A liquid or semi-solid application preparation containing one or more active ingredients intended for application to the skin. A solid dosage form in the shape of a small ball, intended for topical use Colloidion is a liquid usually containing pyroxylin in a mixture of ether and ethanol. It forms a flexible film at the site of application. Page 131 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) A homogeneous, viscous or semisolid preparation, usually an emulsion, consisting of a solution or dispersion of one or more active ingredients in low proportions in a suitable base. A piece or strip of gauze or other suitable fabric, impregnated with a liquid or a semi-solid preparation. A semi-solid preparation containing one or more active ingredients to be applied to skin in order to increase hydration. A dispersion of gas in a liquid or solid creating a semi-solid substance A gel that contains a high proportion of water, in combination with a drug substance and a thickening agent. [To be completed]
irrigation solution A solution, usually sterile, of one or more active ingredients intended for flushing or instilling followed by drainage (including peritoneal dialysis) of wounds, operation cavities, the vagina, the urinary system, or serous cavities such as abdominal and pleural cavities. A semi-solid preparation usually consisting of a solution or dispersion in a suitable base, prepared with the aid of a suitable gelling agent, intended for application to the skin. [To be completed]
[To be completed]
A liquid or semi-solid preparation composed of or containing one or more active ingredients usually intended to be applied to the unbroken skin without friction. [To be completed]
Medicated liquid preparations of a variety of viscosities intended to be applied to the nails in order to obtain a local action. multiple component [To be completed]
Medicated liquid preparations of a variety of viscosities intended to be applied to the nails in order to obtain a local action. A semi-solid preparation intended for topical use, usually consisting of a solution or dispersion of one or more active ingredients in low proportions in a suitable base, usually nonaqueous. [To be completed]
[To be completed]
A liquid preparation containing one or more active ingredients for application to broken skin or mucous Page 132 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) A solid formulation intended for direct application to the skin. [To be completed]
A viscous liquid that is generally applied to wet hair, head and/or scalp areas. It is massaged in to form lather before being rinsed out. A liquid preparation containing one or more active ingredients; it is applied to the skin. A liquid preparation containing one or more active ingredients; it is applied to the scalp areas. A liquid preparation for application after dispersion with a spraying device, intended for use on the skin. [To be completed]
[To be completed]
[To be completed]
transdermal
preparations of varying sizes, containing one or more active substances. They are intended to be applied to the unbroken skin in order to deliver the active substance(s) to the systemic circulation after passing through the skin barrier. INHALATION
inhalation
Capsule for inhalation is a solid preparation with hard shells of various shapes and capacities, usually containing a single dose of active ingredient(s). The content is intended to be inhaled. inhalation
[To be completed]
inhalation
nebulising solution Liquid preparations for inhalation intended to be converted into aerosols by continuously operating nebulisers or metered-dose nebulisers are solutions, suspensions or emulsions. Liquid preparations for nebulisation in concentrated form for use in continuously operating nebulisers are diluted to be prescribed volume with the prescribed liquid before use. Liquids for nebulisation may also be prepared from powders or other forms of solids. inhalation
A powder preparation composed of, or containing, active ingredients which when dispersed in a suitable manner is intended to be self-administered by inhalation via the oral route for local or systemic effect. It is usually inhaled in controlled amounts. Page 133 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) inhalation
A metered dose preparation usually consisting of a solution, suspension or emulsion of one or more active ingredients held under pressure with a suitable propellant or a suitable mixture of propellants. They are intended to be inhaled in controlled amounts and are delivered by the actuation of an appropriate metering valve. inhalation
A liquid preparation composed of, or containing active ingredient(s) which when vaporised or dispersed in a suitable manner (e.g. hand-actuated pump) is intended to release the constituents for inhalation. inhalation
powder for solution A powder formulation intended to be dispersed in suitable diluents before its administration as an inhalation solution. inhalation
Inhalation vapour is solutions, dispersions or solid preparations intended to be converted into vapour. They are usually added to hot water and the vapour generated is inhaled, but may include products that are available as a vapour ready for inhalation. A liquid preparation composed of, or containing, one or more active ingredients for rectal administration. A solid preparation containing one or more active ingredients intended for rectal administration, usually as a single dose. Cream is a multiphase preparation consisting of lipophilic phase and an aqueous phase. Rectal cream is intended to be applied to the ano-rectal region. Ointment is a semi-solid preparation consisting of a single-phase basis in which solids or liquids may be dispensed. Rectal ointment is intended to be applied to the ano-rectal region. [To be completed]
Foam consists of large volumes of gas dispersed in a liquid and generally contains one or more active substances. It is usually formed at the time of administration from a liquid preparation in a pressurised container. Rectal foam is intended to be applied to the ano-rectal region. A liquid preparation containing one or more active ingredients intended for rectal administrations. Rectal suspensions are liquids containing one or more active ingredients suspended in a suitable vehicle intended for rectal administrations. Suspended solids may slowly separate on standing but are easily redispersed. VAGINAL & URETHRAL
Page 134 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) A device designed to be inserted into the uterus. It may contain an active medicament that is slowly released over a period of time. urethral
[To be completed]
urethral
[To be completed]
urethral
irrigation solution [To be completed]
A homogeneous, viscous or semi-solid preparation, usually an emulsion, consisting of a solution or dispersion of one or more active ingredients in low proportions in a suitable base. Vaginal cream is intended to be applied to the skin or mucous membranes of the vagina for protective, therapeutic or prophylactic purposes. [To be completed]
effervescent tablet Effervescent vaginal tablet is a solid preparation intended for vaginal use. Upon insertion, the active ingredient(s) is released by an effervescent-like reaction between the product and the vaginal fluids Foam consists of large volumes of gas dispersed in a liquid and generally contains one or more active substances. It is usually formed at the time of administration from a liquid preparation in a pressurised container. Vaginal foam is intended to be applied to the vaginal area. Gel is a semi-solid preparation usually consisting of a solution or dispersion in a suitable base, prepared with the aid of a suitable gelling agent. Vaginal gel is intended to be applied to the vaginal area. [To be completed]
multiple component [To be completed]
Ointment is a semi-solid preparation consisting of a single-phase basis in which solids or liquids may be dispensed. Vaginal ointment is intended to be applied to the vaginal area. A solid preparation containing one or more active ingredients intended for vaginal administration. epilesional
[To be completed]
solvent for fibrin sealant A solution for use in haemofiltration. A solution for use in dialysis by means of a dialyser. A solution for use in haemofiltration. A solution for use in dialysis by means of a dialyser. Page 135 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) parenteral
A sterile solid preparation containing one or more active ingredients for introduction or grafting into body tissue. Powder for reconstitution for instillation reconstitution for instillation A powder and solvent for instillation is a solid, sterile substance distributed in its final container with a specified volume of a specific sterile liquid or solvent. When shaken together it rapidly forms a clear solution. After dissolution it complies with the requirements for instillation. A thin flat solid preparation containing one or more active ingredients. It is usually intended to disintegrate or dissolve rapidly in contact with the wound. raw materials
Materials used for manufacturing, processing or repacking. Not for retail use. [To be completed]
*parenteral includes intra-arterial, intra-articular, intracavernosal, intracervical, intracisternal, intradermal, intradiscal, intraepidermal, intralesional, intramuscular, intrapleural, intrathecal, intratracheal, intravenous, intravesical, intravitreal. Page 136 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX F – STRENGTH UNIT [17[[18] 6.6.1 The HKMTT strength units will be referencing, and with their definitions extracted from the following standard terminologies:  UK NHS dm+d "Units of Measure (List E) NEHTA AMT Editorial Rules V3.0 - appendix VI – units of measure Table - MTT Strength Unit List
Description
centimetre
millimetre
square centimetre
Biological Units
allergy unit
anti-Xa international unit
anti-Xa international unit Antigenic Herpes simplex unit
D antigen unit
Enzyme-Linked ImmunoSorbent Assay
kallikrein inactivator unit
kallikrein inactivator unit kallikrein inactivator unit/millilitre
kallikrein inactivator unit / mL Kyowa unit
Kyowa unit/vial
Kyowa unit / vial million unit
million unit/milligram
million unit / mg million unit/millilitre
million unit / mL pressor unit
unit / actuation unit/dose
unit/gram
unit / microgram unit/square centimetre
unit/vial
Page 137 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Description
kilocalorie
kilocalorie / mL Expression of proportions
parts per million
International units
British Pharmacopoeia unit
international unit
international unit international unit/gram
international unit / g international unit/milligram
international unit / mg international / mL kilo international unit
kilo international unit kilo international unit/millilitre
kilo international unit / mL kilo international unit/vial
kilo international unit / vial million international unit
million international unit million international unit/millilitre
million international unit / mL Pharmacopoeia Europe unit
United States Pharmacopoeia unit
gram/dose
gram/gram
gram/litre
gram/pack
gram/sachet
gram/vial
kilogram
milligram
Page 138 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Description
milligram iodine
milligram/16 hours
milligram/24 hours
milligram/72 hours
mg / application milligram/square centimetre
microgram
microgram haemagglutinin
microgram/24 hour
microgram / 24 hr microgram / actuation microgram / dose microgram / spray nanogram
Microbiological cultures
billion organisms unit
billion organisms unit billion vibrios
cell culture infectious dose 50% unit
colony forming unit
colony forming unit fluorescent focus unit
fluorescent focus unit Page 139 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Description
international opacity unit
international opacity unit lethal dose 50% unit
million cell culture infectious dose 50% unit
million CCID50 unit million colony forming unit
million colony forming unit million organisms unit
million organisms unit mouse lethal dose 50% unit
organisms unit
plaque forming unit
plaque forming unit thousand organisms unit
thousand organisms unit tissue culture infectious dose 50% unit
tuberculin unit
tuberculin unit/milliliter
Molecular equivalents
micromole
milliosmol
millimole
mole/litre
nanomole
Physical Form
gigabecquerel / mL kilobecquerel / mL Page 140 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Description
megabecquerel / mL millicurie
microcurie
litre/litre
microlitre
millilitre
nanolitre
Page 141 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX G – UNITS OF MEASURE 6.7.1 The HKMTT Units of Measure will be referencing, and with their definitions extracted from the following standard terminologies:  UK NHS dm+d "Units of Measure (List E) NEHTA AMT Editorial Rules V3.0 - appendix VII – units of measure Table – MTT Units of Measure List
Concept Full Description
Short Description
actuation
application
applicator
billion organisms unit
billion organisms unit billion vibrios
British Pharmacopoeial unit
cartridge
centimetre
component
cubic metre
cylinder
D antigen unit
dressing
fluorescent focus unit
fluorescent focus unit gram/pack
gram/sachet
Page 142 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) kyowa unit/vial
kyowa unit / vial litre/litre
microgram / actuation nanolitre
organisms unit
parts per million
pastille
plaque forming unit
plaque forming unit pre-filled injection device
pre-filled injection device pre-filled syringe
pre-filled syringe pressor unit
square metre
unit dose
unit / actuation Page 143 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX H – BASE UNIT 6.8.1 The HKMTT Base units will be referencing, and with their definitions extracted from the following standard terminologies:  HKHA-PHS Base Unit Table Table - MTT Base Unit List
Short Description
Concept Full Description
applicator
billion organisms unit
billion organisms unit billion vibrios
British Pharmacopoeial unit colony forming unit
colony forming unit cubic metre
cylinder
D antigen unit
international unit / g
international unit/gram kilobecquerel / mL
kilocalorie / mL
kilocalorie/millilitre kyowa unit / vial
micromole / L
nanogram
nanogram / mL
nanogram/millilitre Page 144 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) nanolitre
nanolitre / mL
nanolitre/millilitre organisms unit
parts per million pastille
Ph Eur unit
Pharmacopoeia Europe unit pre-filled injection device
pre-filled injection device pre-filled syringe
pre-filled syringe pressor unit
unit dose
unit / microgram
Page 145 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) APPENDIX I – PRESCRIBING DOSE UNIT 6.9.1 The HKMTT Prescribing Dose Units will be referencing, and with their definitions extracted from the following standard terminologies:  HKHA Form Prescribing Dosage Units Table – MTT Prescribing Dose Unit List
Short Description
Concept Full Description
5 mL spoonful
actuation
antigenic Herpes simplex unit
antigenic Herpes simplex unit anti-Xa international unit
anti-Xa international unit application
applicator
billion organisms unit
billion organisms unit billion vibrios
British Pharmacopoeial unit cartridge
colony forming unit
colony forming unit cylinder
D antigen unit
dressing
fluorescent focus unit
fluorescent focus unit kilobecquerel / mL
kyowa unit / vial
LD50 unit
lethal dose 50% unit Page 146 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) megabecquerel / mL
microgram / actuation
microgram/actuation microlitre / g
microlitre / L
microlitre/litre micromole / L
millimole/millilitre million unit / mL
million unit/millilitre nanogram
nanogram / g
nanogram / mL
nanogram/millilitre nanolitre
nanolitre / mL
nanolitre/millilitre organisms unit
parts per million Ph Eur unit
Pharmacopoeia Europe unit plaque forming unit
plaque forming unit pre-filled injection device
pre-filled injection device pre-filled syringe
pre-filled syringe pressor unit
unit dose
unit / dose
Page 147 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 6.10 APPENDIX J – DISPENSING DOSE UNIT 6.10.1 The HKMTT Dispensing Dose Units will be referencing, and with their definitions extracted from the following standard terminologies:  HKHA PHS Form Dispensing Dose Units Table – MTT Dispensing Dose Unit List
Short Description
Concept Full Description
5 mL spoonful
actuation
antigenic Herpes simplex unit
antigenic Herpes simplex unit anti-Xa international unit
anti-Xa international unit application
applicator
billion organisms unit
billion organisms unit billion vibrios
British Pharmacopoeial unit cartridge
colony forming unit
colony forming unit cylinder
D antigen unit
dressing
fluorescent focus unit
fluorescent focus unit kilobecquerel / mL
kyowa unit / vial
LD50 unit
lethal dose 50% unit megabecquerel / mL
Page 148 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) microgram / actuation
microgram/actuation microlitre / g
microlitre / L
microlitre/litre micromole / L
millimole/millilitre nanogram
nanogram / g
nanogram / mL
nanogram/millilitre nanolitre
organisms unit
parts per million Ph Eur unit
Pharmacopoeia Europe unit plaque forming unit
plaque forming unit pre-filled injection device
pre-filled injection device pressor unit
unit dose
unit / dose
Page 149 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 6.11 APPENDIX K – LEGAL CLASSIFICATION [19] 6.11.1 The HKMTT Legal Classifications will be referencing, and with their definitions extracted from the following terminologies:  Compendium of Pharmaceutical Products, Department of Health of HKSAR Table – MTT Legal Classifications for Actual Medicinal Products
Legal Classification
Full Description
Part I Dangerous Drug Part I Poison & Antibiotic Part I Poison & Part I Dangerous Drug PI & DDII&III
Part I Poison & Part II and Part III Dangerous Drug Part I & First Schedule Poison Part I First Schedule Poison & Antibiotic PIS1 & DDI
Part I First Schedule Poison & Part I Dangerous Drug PIS1 & DDII&III
Part I First Schedule Poison & Part II and Part III Dangerous Drug Part I, First and Third Schedule Poison PIS1S3 & A
Part I, First and Third Schedule Poison & Antibiotic PIS1S3 & DDI
Part I, First and Third Schedule Poison & Part I Dangerous Drug Part I, First and Third Schedule Poison & Part II and Part III Dangerous PIS1S3 & DDII&III
Part I & Third Schedule Poison Page 150 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 6.12 ALTERNATIVE EXPRESSION RULES 6.12.1 Multi-ingredient products with combined strength expression In normal circumstances for naming the FSN and PT of VMP and AMP for multi-ingredient products, the strength of each of the component should be appended after each of the individual ingredient component; hence the following syntax should apply: "ingredient1" "strength1" + "ingredient2" "strength2" + "ingredient3" "strength3" "route "dose form" e.g. VMP: amlodipine (as besilate) 5 mg + valsartan 80 mg oral tablet However in some exceptions the combined strength of all ingredients is of more clinically significant values because the combined strength is used during prescribing, with the fact that the strengths and strength ratios of the ingredients are standardized for these items. Hence for these multi-ingredient products the combined strength is used as strength and appended as below (similar to single-ingredient products): "ingredient1" + "ingredient2" + "ingredient3" "route" "dose form" "strength" e.g. for HK-16677 Augmentin tab 375mg where the ingredients for this product includes 250 mg of amoxicillin (as trihydrate) and 125 mg of clavulanate (as potassium), its related product concepts will be expressed as follows: VTM: amoxicillin (as trihydrate) + clavulanate (as potassium) VMP: amoxicillin (as trihydrate) + clavulanate (as potassium) oral tablet 375 mg AMP: Augmentin (amoxicillin (as trihydrate) + clavulanate acid (as potassium)) oral tablet 375 mg Page 151 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) Several groups of clinically relevant information have to be structurally included in the nomenclature of insulin preparations. 6.12.2.2 VTM: The VTM should starts with the word "insulin". ii. The source of origin of insulin should be specified in the VTM descriptions and concepts (e.g. human, porcine, and bovine) except for that insulin produced as human analogs by recombinant DNA technology. iii. Examples of human insulin analog products include: Insulin glargine iv. For other insulin preparations the sources of origin will have to be included, examples are:  Insulin neutral human Insulin isophane human Insulin zinc suspension (soluble) bovine Insulin protamine zinc bovine 6.12.2.3 Dosage form and dosage form level extra information Dosage form field will include information on the dosage form as listed in the appendix (e.g. solution for injection, suspension of injection) while the application design (e.g. cartridge, pen, vial) will be included in the dosage form level extra information. For single ingredient preparations:  The strength should be expressed in terms of international units per mL of the insulin injection as this piece of information is clinically significant for prescribing. For multiple ingredient preparations:  The combined overall strength (units per mL) of the multi-ingredient insulin preparations remain clinically significant as the ratios of the different insulin ingredients are standardized and the drugs are prescribed in terms of the combined strength; whereas Page 152 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) the ratio of the ingredients remains a clinically important information. Therefore the strength expression for these multiple ingredient insulin preparations is modified to suit both purposes. iii. First, the ratio of the insulin ingredients is expressed in terms of percentage, with respective to the ingredient sequence of VTM and is bracketed. Then the combined overall strength of the insulin ingredients follows the ratio information. iv. Strength level extra information The total volume of the preparation (e.g. 3 mL, 10 mL) will be expressed in the Strength level extra information field so as to represent the total amount / units of insulin available in the respective preparations. VTM: insulin isophane human + insulin neutral human VMP: insulin isophane human + insulin neutral human subcutaneous suspension for injection (cartridge) (70%/30%) 100 international unit / mL (3 mL) AMP: Mixtard 30 HM (insulin isophane human + insulin neutral human) subcutaneous suspension for injection (cartridge) (70%/30%) 100 international unit / mL (3 mL) Page 153 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 6.12.3 MULTI-component Products Multi-component products refer to products that comprise of more than one Virtual Medicinal Products within a single pack and registered under a single registration number. The virtual concepts may itself be a single or multiple ingredient products by its own right as a component of the whole product. For the representation of a multi-component product, each component contained should be represented as a virtual medicinal product as described in previous chapters, and to be divided by a semi-colon separator (";") to indicate that each of these VMPs are of a single pharmaceutical form within a single multi-component product code. Each of the components of a multi-component product will have their VTM, VTM+R, VTM+R+F and VMP descriptions expressed as described in previous chapters. Example of multi-component products with two single ingredient components:  Component 1 : varenicline (as tartrate) oral tablet 500 microgram Component 2 : varenicline (as tartrate) oral tablet 1 mg The virtual product concepts will be expressed as:  VTM : varenicline (as tartrate) VTM+R : varenicline (as tartrate) oral VTM+R+F : varenicline (as tartrate) oral tablet VMP : varenicline (as tartrate) oral tablet 500 microgram ; varenicline (as tartrate) oral tablet 1 mg The actual product concept will be expressed as:  TN : Champix (varenicline (as tartrate) TN+R : Champix (varenicline (as tartrate) oral TN+R+F : Champix (varenicline (as tartrate) oral tablet AMP : Champix (varenicline (as tartrate) oral tablet 500 microgram; varenicline (as tartrate) oral tablet 1 mg) Page 154 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 6.12.4.1 Vaccine products often have long and extremely complex names; due to the extraordinary nature of this category of products, MTT product concept expression have been handled in exception to the usual MTT editorial rules. 6.12.4.2 FSNs of such products will be constructed as specified in previous chapters with the detailed ingredient information; in general the PTs will also follow such editorial rules and include the following additional information:  The name of the organisms the vaccine is directed at; Specific information of the vaccines where available (e.g. live attenuated, inactivated, conjugated, split virion, surface antigen); All vaccine product concepts should contain the word "vaccine" as part of the concept description. Example of vaccine product concepts fully specified names:  VTM : hepatitis A virus antigen (inactivated) vaccine) VTM+R : hepatitis A virus antigen (inactivated) vaccine intramuscular VTM+R+F : hepatitis A virus antigen (inactivated) vaccine intramuscular suspension for injection VMP : hepatitis A virus antigen (inactivated) vaccine intramuscular suspension for injection 25 unit / 0.5 mL TN : Vaqta Paediatric (hepatitis A virus antigen (inactivated) vaccine) TN+R : Vaqta Paediatric (hepatitis A virus antigen (inactivated) vaccine) intramuscular TN+R+F : Vaqta Paediatric (hepatitis A virus antigen (inactivated) vaccine) intramuscular suspension for injection AMP : Vaqta Paediatric (hepatitis A virus antigen (inactivated) vaccine) intramuscular suspension for injection 25 unit / 0.5 mL 6.12.4.3 Preferred terms of selected vaccines with excessively long and complicated ingredient details will be constructed in a simplified way such that a more concise and clinically-intuitive description would be expressed: Example of simplified concept preferred term:  VMP Fully Specified Name : diphtheria toxoid adsorbed not less than 30 international unit / 0.5 mL + tetanus toxoid adsorbed not less than 40 international unit / 0.5 mL vaccine parenteral suspension for injection VMP Preferred Term would be simplified to: diphtheria toxoid + tetanus toxoid, adsorbed vaccine parenteral suspension for injection 0.5 mL Page 155 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) This product would contain the following ingredient information:  Ingredient: influenza virus (split virion inactivated) Strength value: 15 Strength unit: microgram Ingredient unit of measure value: 0.5 Ingredient unit of measure: mL Ingredient additional information: A/CALIFORNIA/7/2009 (H1N1)- DERIVED STRAIN USED NYMC X-179A, A/PERTH/6/2009 (H3N2)- LIKE STRAIN USED NYMC X-187 DERIVED FROM A/VICTORIA/210/2009, B/BRISBANE/60/2008 REFERENCE
International Health Terminology Standards Development Organization (IHTSDO). SNOMED CT@ User Guide: July 2011 International Release (US English). Drug Office. Search Drug Database. Department of Health, The Government of the HKSAR. National E-Health Transition Authority (nehta). The NHS Dictionary of Medicines and Devices (dm+d). National E-Health Transition Authority (nehta). Australia Medicines Terminology Editorial Rules Version 3.0. 2009. National E-Health Transition Authority (nehta). Australia Medicines Terminology Editorial Rules Version 3.0. 2009. The NHS Dictionary of Medicines and Devices (dm+d). Editorial Policy Release 2 Version 2.0 2005. The NHS Dictionary of Medicines and Devices (dm+d). Editorial Policy Release 2 Version 2.0 2005. Drug Office. Search Drug Database. Department of Health, The Government of the HKSAR. 10 The NHS Dictionary of Medicines and Devices (dm+d). Virtual Medicinal Product Page 156 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) 11 Department of Health and Ageing. Amendments to TGA approved Terminology for Medicines – July 1999. Australia Government. 2001; 29. 12 Centre for Drug Evaluation and Research (CDER). Data Standard Manual. U.S. Food and Drug Administration. 13 Department of Health. The Compendium of Pharmaceutical Products. The Government 14 The NHS Dictionary of Medicines and Devices (dm+d). Virtual Medicinal Product 15 National E-Health Transition Authority (nehta). Australia Medicines Terminology. 16 Centre for Drug Evaluation and Research (CDER). Data Standard Manual. U.S. Food and Drug Administration. 17 The NHS Dictionary of Medicines and Devices (dm+d). Units of Measure (List E). 18 National E-Health Transition Authority (nehta). Australia Medicines Terminology Editorial Rules Version 3.0. (2009). 19 Department of Health. The Compendium of Pharmaceutical Products. The Government Page 157 of 158 Editorial Guide on Hong Kong Clinical Terminology Table - Drugs (Medication Terminology Table) [Blank Page]
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