Laboratory of Teaching and Research in Social Pharmacy (LEPFS), Department of Pharmacy, Federal University of Sergipe, São Cristóvão, Brazil.
J Clin Pharm Ther. 2019 Jun;44(3):430-439. doi: 10.1111/jcpt.12803. Epub 2019 Jan 30.
Qualified dispensing is fundamental for the promotion of the rational use of medicines. Documentation is an indicator of quality and one of the essential steps in the care process. However, in Brazil, there are no models of clinical documentation applicable to dispensing practices. Thus, the objective of this study was to develop and validate an instrument to document the dispensing process of prescribed medicines.
A methodological development study was carried out from February 2017 to October 2017 in two stages, which were (i) the development of the instrument and (ii) content validation of the proposed instrument. The development phase comprised three stages, which were (i) the elaboration of the prototype based on a previously performed systematic review, (ii) academic brainstorming and (iii) a pre-Delphi consensus. The content validation process was performed using the Delphi technique. The instrument was sent to 40 experts with experience in dispensing, and the consensus among them was calculated using the content validity index (CVI). The study was approved by the Ethics Committee, and all participants signed an informed consent document detailing the terms of the study.
In the development stage, three versions of the instrument were generated, which were the prototype, version 1 (changed after academic brainstorming) and version 2 (changed after the pre-Delphi). In the content validation process of version 2 of the instrument, 23 experts returned their evaluation in the first round of the Delphi process and 17 in the second. All the items obtained a CVI >0.83, which resulted in the validation of the instrument. The final instrument comprised the following sections: general information, the identification of technical and legal problems of prescriptions, the conduct for the resolution of the technical and legal problems of prescriptions, medication dispensed, suspected drug-related problems, verbal guidance, written guidance, referral and the referral result.
The developed and validated instrument presents the main variables that should be documented during the dispensing process.
合格的配药对于促进合理用药至关重要。文件记录是质量的一个指标，也是护理过程的基本步骤之一。然而，在巴西，没有适用于配药实践的临床文件记录模式。因此，本研究的目的是开发和验证一种记录处方药品配药过程的工具。
一项方法学开发研究于 2017 年 2 月至 10 月进行，分两个阶段进行，即（i）工具的开发和（ii）拟议工具的内容验证。开发阶段包括三个阶段，即（i）基于先前进行的系统评价制定原型，（ii）学术头脑风暴和（iii）预 Delphi 共识。内容验证过程使用 Delphi 技术进行。该工具被发送给 40 名具有配药经验的专家，他们之间的共识使用内容有效性指数（CVI）进行计算。该研究获得了伦理委员会的批准，所有参与者都签署了一份知情同意书，详细说明了研究的条款。
在开发阶段，生成了三个版本的工具，即原型、版本 1（学术头脑风暴后更改）和版本 2（预 Delphi 后更改）。在工具版本 2 的内容验证过程中，23 名专家在 Delphi 过程的第一轮中返回了他们的评估，17 名专家在第二轮中返回了他们的评估。所有项目的 CVI>0.83，从而验证了工具的有效性。最终的工具包括以下部分：一般信息、处方技术和法律问题的识别、解决处方技术和法律问题的行为、配发的药物、疑似与药物相关的问题、口头指导、书面指导、转诊和转诊结果。
开发和验证的工具具有在配药过程中应记录的主要变量。
