ISO 21549-7:2016 健康情報学—患者のヘルスカードデータ—パート7：投薬データ | ページ 6

3.1

attribute

characteristic of an object or entity

3.2

batch

amount of material which is uniform in character and quantity as shown by compliance with production and quality assurance test requirements and produced during a defined validated process of manufacture

[SOURCE: EN 375:1992 E, EN 376:1992 E]

3.3

coding scheme

collection of rules that maps the elements of one set onto the elements of a second set

[SOURCE: ISO 21089:2004, 3.25]

3.4

data object

information object

instance of some information object class (3.11) , being composed of a set of fields which conform to the field specifications of the class

[SOURCE: ISO/IEC 8824‑2:2015, 3.4.9]

3.5

dispenser

healthcare professional (3.9) which is a representation of an individual, professionally responsible for filling/dispensing the prescription (3.22)

Note 1 to entry: This is usually the pharmacist, but may be other individuals according to local jurisdiction.

3.6

healthcare

activities, services or supplies related to the health of an individual

Note 1 to entry: This includes more than performing procedures for subjects of care. It includes, for example, the management of information about patients, health status and relations within healthcare framework.

Note 2 to entry: In this document, the term “care” is to be understood as a synonym for “healthcare”.

[SOURCE: ISO 13940:2015, 3.1.1, modified]

3.7

healthcare data card

machine-readable card conformant to ISO/IEC 7810 intended for use within the healthcare domain

3.8

healthcare party

organization (3.16) or person involved in the direct or indirect provision of healthcare services to an individual or to a population

[SOURCE: ENV 13607]

3.9

healthcare professional

person entrusted with the direct or indirect provision of defined healthcare services to a subject of care (3.25) or a population of subjects of care

[SOURCE: ENV 1613]

3.10

immediate container

container that is in direct contact with the pharmaceutical product (3.19)

[SOURCE: ENV 12610]

3.11

information object class

set of fields, forming a template for the definition of a potentially unbounded collection of information objects, the instances of the class

[SOURCE: ISO/IEC 8824‑2:2015, 3.4.10]

3.12

ingredient

substance (3.26) included as a component in a product

Note 1 to entry: In this context, product refers to pharmaceutical product (3.19) .

[SOURCE: ENV 13607]

3.13

magistral medicinal product

extemporaneous medicinal product

medicinal product (3.14) manufactured in a pharmacy or pharmacy department, which is based on a recipe and intended to be used for one and only one subject of care (3.25)

Note 1 to entry: A magistral/extemporaneous medicinal product is also a pharmaceutical product (3.19) .

[SOURCE: ENV 12610, ENV 13607, modified]

3.14

medicinal product

substance (3.26) or combination of substances, which may be administered to human beings or animals for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions

Note 1 to entry: A medicinal product may contain one or more manufactured items and one or more pharmaceutical products (3.19) .

Note 2 to entry: In certain jurisdictions, a medicinal product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis.

[SOURCE: ENV 13607, ENV 12610]

3.15

medicinal product package

delivery unit of a medicinal product (3.14) in an outer container (3.17)

[SOURCE: ENV 12610]

3.16

organization

unique framework of authority within which a person or persons act, or are designated to act towards some purpose

Note 1 to entry: Groupings or subdivisions of an organization may also be considered as organizations where there is a need to identify them for information interchange.

3.17

outer container

container that serves as an external layer of a package

[SOURCE: ENV 12610]

3.18

payment guarantor

organization (3.16) responsible for the total or partial reimbursement or payment of the price of the medicinal product (3.14)

[SOURCE: ENV 13607]

3.19

pharmaceutical product

qualitative and quantitative composition of a medicinal product (3.14) in the dose form approved for administration in line with the regulated product information

Note 1 to entry: A medicinal product may contain one or more pharmaceutical products.

Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

[SOURCE: ISO 11616:2012, 3.1.20, modified]

3.20

prescriber

healthcare professional (3.9) authorized to issue prescriptions (3.22)

[SOURCE: ENV 13607]

3.21

prescribing

process of creating a prescription (3.22)

[SOURCE: ENV 13607]

3.22

prescription

direction created by an authorized healthcare professional (3.9) , to instruct a dispensing agent regarding the preparation and use of a medicinal product (3.14) or medicinal appliance to be taken or used by a subject of care (3.25)

[SOURCE: ENV 13607]

3.23

prescription item

specification created by an authorized healthcare professional (3.9) , to instruct a dispensing agent regarding the preparation and use of single medicinal product (3.14) /medicinal appliance or to inform other parties following dispensing regarding the preparation and use of a single dispensed medicinal product/medicinal appliance

Note 1 to entry: A prescription item may contain administrative details needed for dispensing or derived from dispensing, but does not contain information about the prescriber (3.20) or the subject of care (3.25) for whom the prescription item is prescribed or to whom it has been dispensed.

[SOURCE: ENV 13607]

3.24

prescription set

collection of one or more prescription item(s) (3.23) prescribed and/or dispensed as a unit

[SOURCE: ENV 13607]

3.25

subject of care

person or defined group of persons receiving or registered as eligible to receive healthcare services or having received healthcare services

[SOURCE: ENV 12443]

3.26

substance

matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical

Note 1 to entry: Substances can be either single substances mixture substances or one of a group of specified substances. Single substances shall be defined using a minimally sufficient set of data elements divided into five types: chemical, protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesized together. Pharmacopoeial terminology and defining characteristics will be used when available and appropriate. Defining elements are dependent on the type of substance.

Note 2 to entry: Discrete existence refers to the ability of a substance to exist independently of any other substance. Substances can either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric mixtures) or naturally-occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite molecular structures or materials derived from plants, animals, microorganisms or inorganic matrices for which the chemical structure may be unknown or difficult to define. Substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesised together.

[SOURCE: ISO 11238:2012, 2.1.58]