Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester.
Department of Medicine, University of Massachusetts Medical School, Worcester.
JAMA Intern Med. 2021 May 1;181(5):610-618. doi: 10.1001/jamainternmed.2020.9285.
The National Action Plan for Adverse Drug Event (ADE) Prevention identified 3 high-priority, high-risk drug classes as targets for reducing the risk of drug-related injuries: anticoagulants, diabetes agents, and opioids.
To determine whether a multifaceted clinical pharmacist intervention improves medication safety for patients who are discharged from the hospital and prescribed medications within 1 or more of these high-risk drug classes.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted at a large multidisciplinary group practice in Massachusetts and included patients 50 years or older who were discharged from the hospital and prescribed at least 1 high-risk medication. Participants were enrolled into the trial from June 2016 through September 2018.
The pharmacist-directed intervention included an in-home assessment by a clinical pharmacist, evidence-based educational resources, communication with the primary care team, and telephone follow-up. Participants in the control group were provided educational materials via mail.
The study assessed 2 outcomes over a 45-day posthospital discharge period: (1) adverse drug-related incidents and (2) a subset defined as clinically important medication errors, which included preventable or ameliorable ADEs and potential ADEs (ie, medication-related errors that may not yet have caused injury to a patient, but have the potential to cause future harm if not addressed). Clinically important medication errors were the primary study outcome.
There were 361 participants (mean [SD] age, 68.7 [9.3] years; 177 women [49.0%]; 319 White [88.4%] and 8 Black individuals [2.2%]). Of these, 180 (49.9%) were randomly assigned to the intervention group and 181 (50.1%) to the control group. Among all participants, 100 (27.7%) experienced 1 or more adverse drug-related incidents, and 65 (18%) experienced 1 or more clinically important medication errors. There were 81 adverse drug-related incidents identified in the intervention group and 72 in the control group. There were 44 clinically important medication errors in the intervention group and 45 in the control group. The intervention did not significantly alter the per-patient rate of adverse drug-related incidents (unadjusted incidence rate ratio, 1.13; 95% CI, 0.83-1.56) or clinically important medication errors (unadjusted incidence rate ratio, 0.99; 95% CI, 0.65-1.49).
In this randomized clinical trial, there was not an observed lower rate of adverse drug-related incidents or clinically important medication errors during the posthospitalization period that was associated with a clinical pharmacist intervention. However, there were study recruitment challenges and lower than expected numbers of events among the study population.
ClinicalTrials.gov Identifier: NCT02781662.
《国家药物不良事件预防行动计划》确定了 3 种高优先级、高风险药物类别作为降低药物相关伤害风险的目标：抗凝剂、糖尿病药物和阿片类药物。
确定多方面临床药师干预是否能提高从医院出院并在出院后 1 天或以上服用这些高风险药物类别的患者的用药安全性。
设计、地点和参与者：这项随机临床试验在马萨诸塞州的一家大型多学科实践机构进行，纳入了 50 岁及以上的患者，他们从医院出院并至少服用了 1 种高风险药物。参与者于 2016 年 6 月至 2018 年 9 月期间入组该试验。
药师指导的干预措施包括临床药师的家庭评估、基于证据的教育资源、与初级保健团队的沟通以及电话随访。对照组的参与者通过邮件获得教育材料。
研究评估了出院后 45 天内的 2 个结果：（1）药物不良相关事件，（2）一个亚组定义为临床上重要的药物错误，包括可预防或可改善的药物不良事件和潜在药物不良事件（即可能尚未对患者造成伤害但如果不解决可能会对患者造成未来伤害的药物相关错误）。临床上重要的药物错误是主要的研究结果。
共有 361 名参与者（平均[SD]年龄，68.7[9.3]岁；177 名女性[49.0%]；319 名白人[88.4%]和 8 名黑人[2.2%]）。其中 180 名（49.9%）被随机分配到干预组，181 名（50.1%）分到对照组。所有参与者中，100 名（27.7%）发生了 1 次或多次药物不良相关事件，65 名（18%）发生了 1 次或多次临床上重要的药物错误。干预组发生 81 起药物不良相关事件，对照组发生 72 起。干预组发生 44 起临床上重要的药物错误，对照组发生 45 起。干预并没有显著降低药物不良相关事件的患者发生率（未调整的发生率比，1.13；95%CI，0.83-1.56）或临床上重要的药物错误发生率（未调整的发生率比，0.99；95%CI，0.65-1.49）。
在这项随机临床试验中，与临床药师干预相关的，在出院后期间并没有观察到药物不良相关事件或临床上重要的药物错误发生率较低。然而，研究招募存在挑战，并且研究人群中的事件数量低于预期。
ClinicalTrials.gov 标识符：NCT02781662。
