Development and content validation of an instrument to document the dispensing of prescribed medicines

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.