健康信息学 电子处方的要求

[中文适用范围]： 本文件的适用范围仅限于电子处方（ePrescription）本身，即由开方医疗专业人员发出并由发药医疗专业人员接收的数字文档。所开药品应由授权医疗专业人员发放，以便用于人类患者。本文件不涵盖电子处方在报销行政流程中的应用。本文件规定了适用于电子处方的要求，描述了对所有电子处方均重要的通用原则。本文件适用于人类用药的电子处方。虽然其他类型的产品（如医疗器械、伤口护理产品）也可以通过电子处方订购，但本文件的要求旨在针对具有市场授权的药品以及在药店配制的制剂。本文件不限制适用场景（社区或机构），由国家机构决定适用场景。本文件列出了一些可被视为电子处方中关键数据元素的清单，具体取决于司法辖区或临床环境（如初级医疗、医院等）。确保这些数据元素的真实性属于本文件的适用范围，并将对信息系统的要求产生影响。其他消息、角色和场景（如处方验证、给药、用药记录、患者电子健康记录、护理和发放产品的报销等）不在本文件范围内，因为它们因文化和医疗立法的差异而具有国家或地区特性。然而，在司法辖区范围内，电子处方的要求和内容与这些场景之间存在关联。本文件也不涵盖电子处方的提供或交换方式，以及开方过程本身。开方的物流过程不属于本文件的适用范围。处方既可以发送（推送）给发药人，也可以由发药人自行获取（拉取）。然而，本文件对处方的要求是确保其在两种环境中均能正常运作。 [外文原描述]： The scope of this document is constrained to the content of the electronic prescription (ePrescription) itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. The ePrescription in the administrative workflow of reimbursement is not covered in this document. This document specifies the requirements that apply to ePrescriptions. It describes generic principles that are considered important for all ePrescriptions. This document is applicable to ePrescriptions of medicinal products for human use. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an ePrescription, the requirements in this document are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. This document does not limit the scope to any setting (community, institutional) and leaves it to the national bodies to decide on this matter. This document specifies a list of data elements that can be considered as essential for ePrescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.). Ensuring the authenticity of these data elements is in scope and will have impact on the requirements of information systems. Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are not covered in this document, because they are country-specific or region-specific, due to differences in culture and in legislation of healthcare. However, requirements and content of ePrescriptions within the context of jurisdictions have a relationship with these scenarios. This document also does not cover the way in which ePrescriptions are made available or exchanged, and the process of prescribing itself. The logistic process of prescribing itself is not part of the scope. A prescription can either be sent (pushed) to a dispenser or either be retrieved (pulled) at the dispenser. However, the requirement for the prescription is described, that it will be able to function in both environments.