Desenvolvimento e validação de um instrumento para avaliação de conformidade em serviços de gerenciamento da Terapia Medicamentosa

Abstract

The Comprehensive Medication Management (CMM) is a clinical service based on the theoretical and philosophical framework of pharmaceutical care with purpose to optimize the use of drugs. This service has shown the potential to positively affect the damage caused by the use of drugs in society. However, the difficulties faced by pharmacists and managers to deploy and maintain innovative services such as CMM, following standards that ensure the quality of its offer, may not allow for consolidation of service in the health system. In this context, a potentially useful tool is the accreditation models, which has established itself as strategy able to ensure the quality and safety of health services. In Brazil, accreditation, through conformity assessment, was proposed by the Ministry of Health in 2001 and is regulated by the National Accreditation Organization (ONA). Indicates the criteria to which the services must meet to ensure the minimum of reproducibility, quality and safety. This study aimed to develop and validate by experts a compliance assessment tool based on the model ONA and adapted for CMM services. To achieve these objectives a literature review was performed in order to list the minimum criteria which should make the CMM service. The second time the proposed instrument was validated by content evaluation by experts, called judges, using the Delphi technique. Collaborated as 20 pharmaceutical judges with a minimum one-year experience with CMM and researchers in the area of various parts of Brazil. The judges evaluated the instrument in sequential rounds using Likert scale. They also made arguments on the instrument suggesting alteration, removal or addition of items. Each round was carried out statistical analysis of the opinions through the Content Validity Index (CVI) and interrater-agreement (IRA) and qualitative evaluation of arguments. The rounds are closed when all the obtained minimum consensus criteria of 85% and IRA 61%. During two rounds of reviews 19 items have been modified and 4 new items were added to the instrument. After approval of all items the redesigned instrument was considered finalized.