ISO/TS 22703:2021 健康情報学—投薬安全警告の要件 | ページ 6

3.1

administration

(self-) administering a (prescribed) medicinal product to the patient, using a specified method, and via a defined route, and recording that the act has actually happened at a particular date and time

[SOURCE:ISO/TS 19256:2016, 3.1, modified]

3.2

clinical decision support

CDS

software system that assists healthcare providers in making medical decisions

Note 1 to entry: These types of systems typically require input of patient-specific clinical variables and as a result provide patient-specific recommendations.

[SOURCE:ISO/TR 14639-2:2014, 2.8, modified]

3.3

clinical decision support system

CDSS

software that is designed to be a direct aid to clinical decision-making, in which the characteristics of an individual patient are matched to a computerized clinical knowledge base

Note 1 to entry: Patient-specific assessments or recommendations are then presented to the clinician or the patient to aid in the process of making evidence-based clinical decisions

[SOURCE:ISO/TS 22756:2020, 3.2, modified]

3.4

dispensing

process by which an individual healthcare provider takes in a prescription, assesses that prescription, selects the prescribed medicinal product and delivers that medicinal product to the subject of care or their representative

Note 1 to entry: In most cases, but not necessarily always, the individual healthcare provider concerned will be a Pharmacist.

[SOURCE:ISO/TS 19256:2016, 3.9]

3.5

dispenser

specialization of a healthcare professional which is a representation of an individual professionally responsible for filling/dispensing the prescription

Note 1 to entry: The dispenser is usually a pharmacist but can be other individuals according to local jurisdiction.

[SOURCE:ISO 21549-7:2016, 3.5, modified]

3.6

drug (pharmacy) and therapeutics committee

DTC

forum to bring together all stakeholders involved in decisions about drug use

Note 1 to entry: The described forum can exist at any level within the health-care system – at district level (overseeing primary health-care facilities), in hospitals, or at the national level.

[SOURCE:Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]

3.7

drug utilization review

DUR

authorized, structured, ongoing review of healthcare provider prescribing, pharmacist dispensing and patient use of medication

[SOURCE:Academy of Managed Care Pharmacy – Managed Care Glossary]

3.8

electronic health record

EHR

logical representation of information regarding or relevant to the health of a subject of care

[SOURCE:ISO/TS 13972:2015, 2.24]

3.9

formulary list

list of medicines approved for use in a specific health-care setting

[SOURCE:Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]

3.10

formulary system

principles, criteria, procedures and resources for developing, updating and promoting the formulary (essential medicines) list

[SOURCE:Drug and Therapeutics Committee – A Practical Guide. World Health Organization, 2003]

3.11

knowledge database

system in which knowledge on a specific topic is specified as a set of declarative statements, hierarchical organization of such statements, and relationships between declarative statements, which serves as the underpinning of decision support systems

[SOURCE:ISO/TS 19256:2016, 3.19]

3.12

medication history

record keeping of the specificities of the prescribed/dispensed/OTC medicinal product (e.g. identification, brand, type, form, quantity, dosage)

Note 1 to entry: this record contains the medication still in use as well as the medication no longer in use.

[SOURCE:ISO/TS 19256:2016, 3.23, modified]

3.13

medication safety

freedom from preventable harm with medication use

[SOURCE:ISMP Canada, 2007, available at https://www.ismp-canada.org/definitions.htm#:~:text=Medication%20Safety%3A,did%20not%20reach%20the%20patient ]

3.14

medication use evaluation

performance improvement method that focuses on evaluating and improving medication use processes with the goal of optimal patient outcomes

Note 1 to entry: medication use evaluation may be applied to a medication or therapeutic class, disease state or condition, a medication-use process (prescribing, preparing and dispensing, administering and monitoring) or specific outcomes.

[SOURCE:ASHP Guidelines on Medication-Use Evaluation, available at https://www.ashp.org/-/media/assets/pharmacy-informaticist/docs/sopit-formulary-guideline-medication-use-evalutation.ashx?la=en ]

3.15

medicinal product

substance or combination of substances that 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

[SOURCE:ISO 11615:2017, 3.1.50, modified]

3.16

monograph

<medicinal products> written, unbiased evaluation of a specific medication

Note 1 to entry: Such a document includes the drug name, therapeutic class, pharmacology, indications for use, summary of clinical trials, pharmacokinetics/dynamics, adverse effects, drug interactions, dosage regimens and cost.

[SOURCE:ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System, available at https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/gdl-pharmacy-therapeutics-committee-formulary-system.ashx ]

3.17

overutilization

use of a drug in a quantity, strength or duration that is greater than necessary to achieve a desired therapeutic goal or that puts the recipient at risk of a clinically significant undesirable effect, or both

[SOURCE:US CFR 42§456.702, available at https://www.govinfo.gov/content/pkg/CFR-2011-title42-vol4/pdf/CFR-2011-title42-vol4-sec456-702.pdf ]

3.18

pharmacy electronic health record

PEHR

logical representation of information regarding or relevant to the health of a subject of care in pharmacies in community or organized healthcare organizations

[SOURCE:Pharmacy Health Information Technology Collaborative HL7 EHR-System for a Pharmacist/Pharmacy Electronic Health Record Implementation Guide for Community Practice, available at https://www.hl7.org/documentcenter/public/standards/informative/13-294_HITSbook_HL7_Web.pdf ]

3.19

predetermined standard

criteria and standard that has been established in accordance with the requirements of a drug use review programme

[SOURCE:US CFR 42§456.702, available at https://www.govinfo.gov/content/pkg/CFR-2011-title42-vol4/pdf/CFR-2011-title42-vol4-sec456-702.pdf ]

3.20

prescribing

creating a prescription

[SOURCE:ISO/TS 19256:2016, 3.33]

3.21

prescription

direction created by an authorized healthcare person to instruct a dispensing agent regarding the preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

Note 1 to entry: The term “prescription” alone should be avoided as it is colloquially used at random for the following terms: new prescription message, prescription set and prescription item. Further, it is also used to describe a prescription form. The use of the terms prescription set, prescription item and new prescription message where appropriate is recommended.

[SOURCE:ISO/TS 19256:2016, 3.34]

3.22

screening

process of inspecting data for errors and correcting them prior to doing data analysis

Note 1 to entry: The screening can involve checking raw data, identifying outliers and dealing with missing data.

[SOURCE:Business Dictionary, WebFinance Inc.]

3.23

substance

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

[SOURCE:ISO 11238:2018, 3.84, modified]

3.24

underutilization

use of a drug by a beneficiary [recipient] in insufficient quantity, strength or duration to achieve a desired therapeutic goal or that puts the recipient at risk of a clinically significant undesired effect, or both

[SOURCE:US CFR 42§456.702, available at https://www.govinfo.gov/content/pkg/CFR-2011-title42-vol4/pdf/CFR-2011-title42-vol4-sec456-702.pdf ]