1 Grupo Promoción y Prevención Farmacéutica, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia UdeA, Medellín, Colombia.
2 Grupo Promoción y Prevención Farmacéutica, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia UdeA, Medellín, Colombia, and Humax Pharmaceutical, La Estrella, Antioquia, Colombia.
J Manag Care Spec Pharm. 2017 Jan;23(1):74-84. doi: 10.18553/jmcp.2017.23.1.74.
Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I.
To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up.
This study is based on the EMDADER-TAB trial, which was an RCT designed to compare pharmaceutical care with the usual care given to outpatients with BD-I in a psychiatric clinic. The main outcome was the use of health care services, using Kaplan-Meier methods and Cox regression. The trial protocol was registered in ClinicalTrials.gov (Identifier NCT01750255).
92 patients were included in the EMDADER-TAB study: 43 pharmaceutical care patients (intervention group) and 49 usual care patients (control group). At baseline, no significant differences in demographic and clinical characteristics were found across the 2 groups. After 1 year of follow-up, the risk of hospitalizations and emergencies was higher for the control group than for the intervention group (HR = 9.03, P = 0.042; HR = 3.38, P = 0.034, respectively); however, the risk of unscheduled outpatient visits was higher for the intervention group (HR = 4.18, P = 0.028). There was no "placebo" treatment, and patients in the control group might have produced positive outcomes and reduced the magnitude of differences compared with the intervention group.
Compared with usual care, pharmaceutical care significantly reduced hospitalizations and emergency service consultations by outpatients with BD-I.
This study received funding from the Universidad de Antioquia, Committee for Development Research and Sustainability Program, CODI, (2013-2014 and 2014-2015). Humax Pharmaceutical provided support for the initial development of the EMDADER-TAB trial without commercial interest in the outcomes derived from the trial. Salazar-Ospina reports grants from Credito Beca Francisco José de Caldas Scholarship for Doctoral Programs (528), which also contributed to the support of this study. González-Avendaño is an employee of Humax Pharmaceutical. The other authors have nothing to disclose. Study concept and design were contributed by Benjumea, Faus, and Rodriguez, along with Salazar-Ospina and Amariles. Salazar-Ospina took the lead in data collection, assisted by González-Avendaño, and data interpretation was performed by Salazar-Ospina, Hincapié-García, and González-Avendaño. The manuscript was written primarily by Salazar-Ospina, with assistance from Amariles and González-Avendaño, and revised by all the authors.
双相情感障碍 I 型（BD-I）是一种慢性病，其特征是反复发作，伴有缓解期。药剂师可以通过与多学科医疗团队合作提供药物护理，为这些患者改善健康结果；然而，需要更多来自随机对照试验（RCT）的证据来证明药物护理对 BD-I 患者的影响。
通过比较患者在基线至 1 年随访期间住院、急诊就诊和非计划门诊就诊次数的减少，评估使用 Dader 方法的药物干预对 BD-I 患者的效果。
本研究基于 EMDADER-TAB 试验，该试验是一项 RCT，旨在比较精神科诊所中 BD-I 门诊患者的药物护理与常规护理。主要结局是使用卫生保健服务，使用 Kaplan-Meier 方法和 Cox 回归。试验方案在 ClinicalTrials.gov 注册（标识符 NCT01750255）。
92 名患者被纳入 EMDADER-TAB 研究：43 名药物护理患者（干预组）和 49 名常规护理患者（对照组）。在基线时，两组在人口统计学和临床特征方面没有显著差异。经过 1 年的随访，对照组的住院和急诊风险高于干预组（HR = 9.03，P = 0.042；HR = 3.38，P = 0.034）；然而，干预组的非计划门诊就诊风险更高（HR = 4.18，P = 0.028）。没有“安慰剂”治疗，对照组的患者可能会产生积极的结果，并与干预组相比，减少差异的幅度。
与常规护理相比，药物护理显著降低了 BD-I 门诊患者的住院和急诊就诊率。
这项研究得到了 Universidad de Antioquia、委员会发展研究和可持续性计划（CODI）的资助（2013-2014 年和 2014-2015 年）。Humax 制药公司为 EMDADER-TAB 试验的初步开发提供了支持，但对试验结果没有商业利益。Salazar-Ospina 报告说，他获得了 Credito Beca Francisco José de Caldas 奖学金博士项目（528）的资助，这也为这项研究提供了支持。González-Avendaño 是 Humax 制药公司的员工。其他作者没有什么可披露的。Benjumea、Faus 和 Rodriguez 提出了研究的概念和设计，Salazar-Ospina、Amariles 和 Hincapié-García 参与了数据收集，Salazar-Ospina 主要负责数据解释，Hincapié-García 和 González-Avendaño 协助，Amariles 和 González-Avendaño 参与了论文的撰写和修订。
