Leguelinel-Blache Géraldine, Bouvet Sophie, Bedouch Pierrick, Bachelet Bérengère, Chenailler Catherine, Dantin Thomas, Geneletti Laure, Janes Alexia, Scher Florence, Cireașă Bogdan, Kinowski Jean-Marie, Castelli Christel, Roux-Marson Clarisse
Pharmacy Department, Nîmes University Hospital, University of Montpellier, Nîmes, France.
Institute Desbrest of Epidemiology and Public Health, University of Montpellier, INSERM, Montpellier, France.
BMC Geriatr. 2025 Jul 11;25(1):516. doi: 10.1186/s12877-025-06122-1.
Improving medication safety implies patient-centred multidisciplinary cooperation. During the hospital stay for an acute care episode, the patient needs a comprehensive management to guarantee the best possible outcome.
The study was designed as a non-blinded, multicentre stepped-wedge cluster randomised clinical trial, taking place in six French University Hospitals. Each cluster began with the control period in which standard care did not include pharmaceutical intervention. Every 14-day period, one hospital unit was electronically randomised to switch to the intervention period until all cluster groups received the intervention, which consisted of collaborative pharmaceutical care (CPC) associating medication reconciliation at hospital admission, pharmaceutical analysis of the medication order, medication review and collaborative meeting. The primary outcome was assessing the intervention through the rate of patients with at least one medication error (ME) on the admission medication order (such as omission, wrong dose or wrong route of administration), comparing the two periods.
CPC decreased the rate of patients with at least one ME from 88.9% (n = 243) to 29.2% (n = 267) (p < 0.0001). A total of 1817 MEs were discovered, of which 1121 (61.7%) were in the control period and 696 (38.3%) in the intervention period before resolution by the CPC. After resolving 567 of them, 129 medication errors still remained after CPC. So, a median of 3 MEs [IQR = 1;6] per patient were detected in the control period vs 0 [IQR = 0;1] after CPC in the intervention period (p < 0.0001). Patients were 21-times more likely to avoid a ME with CPC (OR: 20.8 [8.3;52.2], p < 0.0001). The rate of patients with a 2-3 critical ME level decreased from 70.8% to 12.0% in the control vs intervention periods respectively (OR: 18.4 [7.7;43.9], p < 0.0001).
CPC can prevent the occurrence of MEs and thus can improve inpatients' medication management and safety. Pharmacists play a key role in combating medication-related harm in healthcare settings.
This study is registered on ClinicalTrials.gov with the reference number NCT02598115 (2015-11-04).
提高用药安全性意味着以患者为中心的多学科合作。在急性病住院期间，患者需要全面管理以确保获得最佳治疗效果。
本研究设计为一项非盲、多中心阶梯式楔形整群随机临床试验，在六家法国大学医院进行。每个整群开始时为对照期，在此期间标准护理不包括药物干预。每14天为一个周期，一个医院科室通过电子随机方式转换到干预期，直到所有整群组都接受干预，干预措施包括协作药学服务（CPC），即在入院时进行用药核对、医嘱药学分析、用药审查和协作会议。主要结局是通过比较两个时期入院医嘱上至少有一个用药错误（如遗漏、剂量错误或给药途径错误）的患者比例来评估干预效果。
CPC使至少有一个用药错误的患者比例从88.9%（n = 243）降至29.2%（n = 267）（p < 0.0001）。共发现1817个用药错误，其中1121个（61.7%）在对照期，696个（38.3%）在干预期，这些错误在CPC解决之前存在。在解决了其中567个错误后，CPC实施后仍有129个用药错误。因此，对照期每位患者检测到的用药错误中位数为3个[四分位间距 = 1；6]，而干预期CPC实施后为0个[四分位间距 = 0；1]（p < 0.0001）。患者通过CPC避免用药错误的可能性高21倍（比值比：20.8 [8.3；52.2]，p < 0.0001）。对照期与干预期相比，2 - 3级严重用药错误的患者比例分别从70.8%降至12.0%（比值比：18.4 [7.7；43.9]，p < 0.0001）。
CPC可预防用药错误的发生，从而改善住院患者的用药管理和安全性。药剂师在医疗环境中对抗与用药相关的危害方面发挥着关键作用。
本研究已在ClinicalTrials.gov上注册，注册号为NCT02598115（2015 - 11 - 04）。
