Heymans Institute of Pharmacology, Ghent University, Belgium.
Int J Med Inform. 2014 Jan;83(1):47-56. doi: 10.1016/j.ijmedinf.2013.09.004. Epub 2013 Oct 5.
The aim is to describe the process, principles and results of the International Nonproprietary Name (INN) prescribing project in Belgium. The purpose of this project was to operationalize electronic INN prescribing for outpatient care in daily medical practice and to develop a factual database which can be used in electronic INN prescribing applications.
The operationalization process consisted of three phases: (1) expert consultation, (2) review by regulatory authorities and (3) test phase with stakeholders and end-users.
The INN prescribing project resulted into (1) operational rules for electronic INN prescribing and (2) a reference database to be implemented in commercial medical software. The operational rules for electronic INN prescribing define valid INN groups as sets of equivalent medicinal products, described by three elements: the therapeutic moiety (the active part of the therapeutic ingredient) or combination of therapeutic moieties, the strength (with standardized denominators), and the method of administration (with simplified but standardized options). The operational rules also define two categories of exemptions for INN prescribing: INN groups where the first choice of treatment should be continued throughout the therapy period (NO SWITCH) and medicinal product groups not suitable for INN prescribing (NO INN). The reference database is the result of the virtual classification of the Belgian therapeutic arsenal into INN groups, according to the operational rules.
Defining the operational rules for INN prescribing for and with different stakeholders was a difficult yet feasible assignment. The INN prescribing project resulted into explicit operational rules and a reference database. The Belgian experience may provide important information for other countries planning to operationalize or refine electronic INN prescribing. It can also be used for a thorough evaluation of the impact of the new concept of INN prescribing on daily practice and on medical education.
描述比利时国际非专利名称(INN)处方项目的过程、原则和结果。该项目的目的是将门诊医疗中电子 INN 处方化,并开发一个可用于电子 INN 处方应用的事实数据库。
实施过程包括三个阶段:(1)专家咨询,(2)监管机构审查,(3)利益相关者和最终用户测试阶段。
INN 处方项目产生了(1)电子 INN 处方的操作规则,(2)商业医疗软件中实施的参考数据库。电子 INN 处方的操作规则将有效的 INN 组定义为等效药物的集合,由三个元素描述:治疗部分(治疗成分的活性部分)或治疗部分的组合、强度(具有标准化的分母)和给药方法(具有简化但标准化的选择)。操作规则还定义了 INN 处方的两种豁免类别:治疗期间应继续选择的 INN 组(NO SWITCH)和不适合 INN 处方的药物组(NO INN)。参考数据库是根据操作规则,将比利时治疗武器库虚拟分类为 INN 组的结果。
为不同利益相关者定义 INN 处方的操作规则是一项困难但可行的任务。INN 处方项目产生了明确的操作规则和参考数据库。比利时的经验可能为其他计划将电子 INN 处方化或完善的国家提供重要信息。它还可用于彻底评估新的 INN 处方概念对日常实践和医学教育的影响。