Albabtain Basmah, Bawazeer Ghada, Paudyal Vibhu, Cheema Ejaz, Alqahtani Abdulaziz, Bahatheq Ahmed, Price Malcolm J, Hadi Muhammad Abdul
Department of Pharmacy Practice, College of Pharmacy, Princess Nourah Bint Abdulrahaman University, Riyadh, Saudi Arabia.
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Sci Rep. 2024 Aug 1;14(1):17818. doi: 10.1038/s41598-024-65759-x.
This study was aimed to evaluate the impact of community pharmacy (CP)-based medication therapy management (MTM) program on clinical and humanistic outcomes in patients with uncontrolled diabetes. An open label, parallel-group randomised controlled trial was undertaken at a community pharmacy in Riyadh city, Kingdom of Saudi Arabia. Patients with a diagnosis of uncontrolled diabetes (HbA1c of ≥ 8%) meeting the eligibility criteria were randomised to receive either the MTM programme provided by pharmacists or standard care. The primary outcome was change in HbA1c over 6 months. Secondary outcomes included: changes in clinical parameters (blood pressure (BP), lipid profile, serum creatinine (SCr) and albumin-to- creatinine ratio (ACR)), types of drug-related problems (DRPs), health service utilization (HSU), adherence, diabetes distress and overall patient satisfaction with the service at 6-month. A sufficiently powered sample of 160 participants with a mean age was 50 years (SD ± 11.9) was recruited. The majority of the patients (68.1%) were male and had diabetes for more than eight years [IQR 3, 14]. After adjusting for baseline HbA1c, compared to the control group, the mean HbA1c level was 0.02% (p = 0.929) and 0.2% (p = 0.47) lower in the intervention arm at 3-month and 6-month respectively. However, these differences were not statistically significant. Nonetheless, within each arm, there was a significant improvement in HbA1c from baseline. Furthermore, the intervention arm demonstrated improvement in BP control (SBP lowered by 3.2 mmHg (p = 0.05) and DBP lowered by 3.8 mmHg (p = 0.008)). During the study period, none of the participants in the intervention group reported hospitalization or ER visits compared to 14 patients in the control group [OR 0.069 (95% CI 0.004, 1.3)]. Patient satisfaction as measured by Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0) was significantly higher among MTM program participants compared to standard care (p = 0.00001). Patients in the MTM program were eight times more likely to be adherent compared to the patients in the standard care [OR 7.89 (95% CI 3.6, 17.4)]. MTM program metrics showed that per patient, the pharmacists spent a median of 35 [IQR 30, 44.5] minutes at the initial visit and 20 [IQR 10, 25] minutes during the 6-month visit. The number of DRPs had significantly dropped in the intervention arm at 3 and 6-month (p = 0.0001). In conclusion, CP-based MTM program can improve health outcomes and prevent hospitalisations in patients with diabetes. These findings support the implementation of CP-based MTM services for patients with diabetes in the Kingdom of Saudi Arabia.
本研究旨在评估基于社区药房(CP)的药物治疗管理(MTM)项目对糖尿病控制不佳患者的临床和人文结局的影响。在沙特阿拉伯王国利雅得市的一家社区药房进行了一项开放标签、平行组随机对照试验。符合入选标准的糖尿病控制不佳(糖化血红蛋白[HbA1c]≥8%)患者被随机分为两组,分别接受药剂师提供的MTM项目或标准护理。主要结局是6个月内HbA1c的变化。次要结局包括:临床参数(血压[BP]、血脂谱、血清肌酐[SCr]和白蛋白与肌酐比值[ACR])的变化、药物相关问题(DRP)的类型、卫生服务利用(HSU)、依从性、糖尿病困扰以及患者在6个月时对服务的总体满意度。招募了160名平均年龄为50岁(标准差±11.9)的样本量充足的参与者。大多数患者(68.1%)为男性,患糖尿病超过8年[四分位间距3,14]。在调整基线HbA1c后,与对照组相比,干预组在3个月和6个月时的平均HbA1c水平分别低0.02%(p = 0.929)和0.2%(p = 0.47)。然而,这些差异无统计学意义。尽管如此,每组内HbA1c较基线均有显著改善。此外,干预组在血压控制方面有改善(收缩压降低3.2 mmHg[p = 0.05],舒张压降低3.8 mmHg[p = 0.008])。在研究期间,干预组没有参与者报告住院或急诊就诊,而对照组有14名患者[比值比0.069(95%置信区间0.004,1.3)]。通过药剂师服务患者满意度问卷2.0(PSPSQ 2.0)测量的患者满意度在MTM项目参与者中显著高于标准护理(p = 0.00001)。与标准护理组患者相比,MTM项目组患者的依从性高出8倍[比值比7.89(95%置信区间3.6,17.4)]。MTM项目指标显示,每位患者在初次就诊时药剂师平均花费35[四分位间距30,44.5]分钟,在6个月随访时花费20[四分位间距10,25]分钟。干预组在3个月和6个月时DRP的数量显著下降(p = 0.0001)。总之,基于CP的MTM项目可以改善糖尿病患者的健康结局并预防住院。这些研究结果支持在沙特阿拉伯王国为糖尿病患者实施基于CP的MTM服务。