一份以患者为中心的处方药标签，以促进合理用药和依从性。
A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence.
作者信息
Wolf Michael S, Davis Terry C, Curtis Laura M, Bailey Stacy Cooper, Knox JoAnn Pearson, Bergeron Ashley, Abbet Mercedes, Shrank William H, Parker Ruth M, Wood Alastair J J
机构信息
Health Literacy and Learning Program, Division of General Internal Medicine, Feinberg School of Medicine at Northwestern University, 750 N. Lake Shore Drive, 10th Floor, Chicago, IL, 60611, USA.
Department of Learning Sciences, School of Education and Social Policy, Northwestern University, Evanston, IL, USA.
出版信息
J Gen Intern Med. 2016 Dec;31(12):1482-1489. doi: 10.1007/s11606-016-3816-x. Epub 2016 Aug 19.
BACKGROUND
Patient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk.
OBJECTIVE
To test the effectiveness of a patient-centered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard.
DESIGN
Two-arm, multi-site patient-randomized pragmatic trial.
PARTICIPANTS
English- and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) ≥30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking ≥2 oral medications.
INTERVENTION
A patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime).
MAIN MEASURES
Demonstrated proper use of a multi-drug regimen; medication adherence measured by self-report and pill count at 3 and 9 months.
KEY RESULTS
A total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13-4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63-2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08, 95 % CI 1.15-22.37) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17-6.53).
CONCLUSIONS
A simple modification to pharmacy-generated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens. Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849.
背景
患者对处方药标签说明的误解是药物无意误用和不良健康后果的常见原因。识字能力有限和英语水平较低的人面临的风险更大。
目的
与现行标准相比，测试以患者为中心的药物标签策略（包括通用用药时间表[UMS]）在改善正确用药方案使用和依从性方面的有效性。
设计
双臂、多中心患者随机实用试验。
参与者
来自弗吉尼亚州北部八个社区健康中心的讲英语和西班牙语的患者，他们从中央配药药房获得处方，且满足以下条件：1）年龄≥30岁；2）被诊断患有2型糖尿病和/或高血压；3）服用≥2种口服药物。
干预措施
一种以患者为中心的标签（PCL）策略，该策略纳入了基于证据的格式和内容做法，包括优先信息、更大的字体大小和增加的空白空间。最值得注意的是，使用UMS传达说明，UMS使用标准时间间隔来表示何时服药（早晨、中午、晚上、就寝时间）。
主要测量指标
证明正确使用多药方案；通过自我报告和3个月及9个月时的药丸计数来衡量药物依从性。
关键结果
共有845名患者参与了该研究（合作率为85.6%）。接受PCL的患者在首次接触时（76.9%对70.1%，p = 0.06）和9个月时（85.9%对77.4%，p = 0.03）对其药物方案的正确使用情况略好。PCL对讲英语的患者有显著效果（比值比[OR]为2.21，95%置信区间[CI]为1.13 - 4.31），但对讲西班牙语的患者没有效果（OR为1.19，95% CI为0.63 - 2.24）。总体而言，该干预措施并未改善药物依从性。然而，在识字能力有限的患者中（OR为5.08，95% CI为1.15 - 22.37）以及对于每天需要服用≥2次药物的患者（OR为2.77，95% CI为1.17 - 6.53），发现PCL有显著益处。
结论
对药房生成的标签进行简单修改，所需投资极少，可在一定程度上改善用药方案的使用和依从性，主要针对识字能力有限和用药方案更复杂的患者。试验注册（ClinicalTrials.gov）：NCT00973180，NCT01200849。
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