Development and validation of a pharmacoeconomic tool for decision-making in the implementation of pharmaceutical care for hypertensive patients in the public health system

Author(s)

Maurilio de Souza Cazarim

• Document type: Doctoral Thesis
• Press: Ribeirão Preto.
• Institution: Universidade de São Paulo (USP). Faculdade de Ciências Farmacêuticas de Ribeirão Preto (PCARP/BC)
• Defense date: 2019-07-15

Examining board members

Leonardo Régis Leira Pereira; Alexander Itria; Emília Vitória da Silva; Fabiana Rossi Varallo

• Advisor: Leonardo Régis Leira Pereira

Abstract

Introduction and Objective: Systemic arterial hypertension (SAH) is a risk factor for 9.4 million deaths worldwide. In Brazil, SAH has attributed an annual cost of approximately one and a half billion to the Brazilian Public Health System (BPHS). Pharmaceutical Care (PC) is able to avoid complications of SAH and reducing health costs. In the long-term analysis of PC was showed that the net return on investment in this pharmaceutical practice may reach R$ 3,791,111.13 over ten years. Alongside the methodology developed for this analysis was possible to elaborate a pharmacoeconomic tool for the implementation of PC in BPHS. However, for this tool becomes applicable in society there is a need for programming and validate it. In addition, it is possible to improve itself by adding the measurement of the monetary return when evaluating the morbidities associated with the complications of SAH. Then, this study aims to programme and validates the pharmacoeconomic tool to assist the decision-making process in the implementation of the PC in the BPHS incorporating Human Network Disease to predict the epidemiological impact and return of investment of this pharmaceutical practice. Methods: It is a pharmacoeconomic study with application of modeling, nested to a systematic review. The results of the systematic review were tabulated and applied in the restructuring and development of the pharmacoeconomic tool. In addition, the Markov model was restructured to measure the effect of CF treatment in ten years and its impact on cardiovascular diseases (CVDs) and chronic kidney disease (CKD) and morbidities associated with them, by studies of proteomics that address Human Netwok Disease. In addition, the tool was programmed with the data from this study and then validated in two steps: content\'s validation of a questionnaire for validation of software and double validation of the tool\'s feasibility for analysis of the construct. Results: 41 studies were retrieved in the systematic review. The most prevalent PC model was the development by the author himself, 27 studies (65.9%). The quality of studies that showed worsening in blood pressure values was worse than the others, w = 7.00 [p = 0.036]. The mean reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP) in the intervention group compared to the control group was -7.71 (95% CI, -10.93 to -4.48) and -3, 66 (95% CI, -5.51 to -1.80), [p <0.001]. Regarding cardiovascular risk, the PC functioned as a protection factor RR = RR = 0.570 (95% CI 0.431 - 0.750). The Plot funnel showed that there was no asymmetry to support a bias p = 0.4949. When compared to conventional care, PC was a cost-effective strategy in 78.0% of the simulations for the life-years gained (LYGs) and 69.0% for quality-adjusted life years (QALYs). It is worth noting that there was a 64.3% and 59.5% chance of PC being more cost-effective than conventional care for LYGs and QALYs, respectively. There was a return on investment for PC of R$ 268.53, which represented a reduction to R$ 251.47 in the cost of the hypertensive patient per year for the SUS. The number needed to treat in 10 years means that PC must treat four and eight patients to avoid death due to CVD and CKD, respectively. The reduction in morbidities associated with complications was measured in the RR of 0.92 (0.90 - 0.93, 95% CI) [p <0.05]. After being programmed, the tool was registered as Pharmatool®. The programming of the tool made possible the planning for the investment in PC programs and, thus, it would be possible to plan goals, in ten years, for population followed-up by PC, indicators as blood pressure control, SAH complications to be avoided and financial return of monetary application carried out in the structuring of the CF. The validation questionnaire for Pharmatool® was satisfactory for content validity. It presented reliable interpretability, more than 50% of the answers considered satisfactory in all the questions. The internal consistency analysis showed the Cronbach\'s alpha equal to 0.819. The satisfaction of Pharmatool® users was greater than 75%.Conclusion: The systematic review and meta-analysis data incorporated in the Markov model showed more robust results for the projection of costs and outcomes, which evidenced that the FC was a cost-effective strategy to SUS regarding life expectancy and quality of life and, able to have a return on investment reducing the cost of hypertensive patients to SUS. In addition, the validation tool for the pharmacoeconomic tool was considered validated and the feasibility of Pharmatool® was measured by the satisfaction of most users. (AU)

• FAPESP's process: 16/03584-1 - DEVELOPMENT AND VALIDATION OF A PHARMACOECONOMIC TOOL FOR THE IMPLEMENTATION OF PHARMACEUTICAL CARE FOR HYPERTENSIVE PATIENTS IN THE PUBLIC HEALTH SYSTEM OF BRAZIL
• Grantee: Maurilio de Souza Cazarim
• Support Opportunities: Scholarships in Brazil - Doctorate