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开发和用户测试新的药房标签格式——一项为标签标准提供信息的研究。

Developing and user testing new pharmacy label formats-A study to inform labelling standards.

机构信息

The University of Sydney School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.

School of Healthcare, University of Leeds, Leeds, UK.

出版信息

Health Expect. 2021 Aug;24(4):1125-1136. doi: 10.1111/hex.13203. Epub 2021 Jun 2.

DOI:10.1111/hex.13203
PMID:34076940
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8369108/
Abstract

BACKGROUND

Dispensed prescription medicine labels (prescription labels) are important information sources supporting safe and appropriate medicines use.

OBJECTIVE

To develop and user test patient-centred prescription label formats.

METHODS

Five stages: developing 12 labels for four fictitious medicines of varying dosage forms; diagnostic user testing of labels (Round 1) with 40 consumers (each testing three labels); iterative label revision, and development of Round 2 labels (n = 7); user testing of labels (Round 2) with 20 consumers (each testing four labels); labelling recommendations. Evaluated labels stated the active ingredient and brand name, using various design features (eg upper case and bold). Dosing was expressed differently across labels: frequency of doses/day, approximate times of day (eg morning), explicit times (eg 7 to 9 AM), and/or explicit dosing interval. Participants' ability to find and understand medicines information and plan a dosing schedule were assessed.

RESULTS

Participants demonstrated satisfactory ability to find and understand the dosage for all label formats. Excluding active ingredient and dosing schedule, 14/19 labels (8/12 in Round 1; 6/7 in Round 2) met industry standard on performance. Participants' ability to correctly identify the active ingredient varied, with clear medicine name sign-posting enabling all participants evaluating these labels to find and understand the active ingredient. When planning a dosing schedule, doses were correctly spaced if the label stated a dosing interval, or frequency of doses/day. Two-thirds planned appropriate dosing schedules using a dosing table.

CONCLUSIONS

Effective prescription label formatting and sign-posting of active ingredient improved communication of information on labels, potentially supporting safe medicines use.

PATIENT AND PUBLIC INVOLVEMENT

Consumers actively contributed to the development of dispensed prescription medicine labels. Feedback from consumers following the first round was incorporated in revisions of the labels for the next round. Patient and public involvement in this study was critical to the development of readable and understandable dispensed prescription medicine labels.

摘要

背景

配药处方标签(处方标签)是支持安全合理用药的重要信息来源。

目的

制定并测试以患者为中心的处方标签格式。

方法

五个阶段:为四种不同剂型的虚构药物开发 12 个标签;对标签进行诊断性用户测试(第 1 轮),共有 40 名消费者(每人测试三个标签);标签修订和第 2 轮标签开发(n=7);对 20 名消费者(每人测试四个标签)进行标签用户测试;标签建议。评估标签陈述了活性成分和品牌名称,使用了各种设计特征(例如大写和粗体)。剂量在标签上的表示方式不同:每天的剂量频率、一天中的大致时间(例如早上)、明确的时间(例如 7 至 9 点)和/或明确的给药间隔。评估了参与者查找和理解药物信息以及制定给药计划的能力。

结果

参与者在查找和理解所有标签格式的剂量方面表现出令人满意的能力。不包括活性成分和给药方案,19 个标签中有 14 个(第 1 轮 12 个中的 8 个;第 2 轮 7 个中的 6 个)符合行业标准。参与者正确识别活性成分的能力各不相同,通过明确的药物名称路标,所有评估这些标签的参与者都能够找到并理解活性成分。在计划给药方案时,如果标签中注明了给药间隔或每天的剂量次数,则剂量可以正确间隔。三分之二的人使用给药表计划了适当的给药方案。

结论

有效的处方标签格式和活性成分的路标显著提高了标签信息的沟通,可能有助于安全用药。

患者和公众的参与

消费者积极参与了配药处方标签的制定。在第一轮之后收到的消费者反馈意见被纳入下一轮标签的修订。患者和公众在本研究中的参与对开发可读和可理解的配药处方标签至关重要。

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本文引用的文献

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Comparative User Testing of Australian and UK Over-the-Counter Labels and Leaflets for Diclofenac.双氯芬酸澳大利亚和英国非处方标签及说明书的用户对比测试
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Best-practices for the design and development of prescription medication information: A systematic review.
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BMJ Open. 2021 Nov 18;11(11):e053969. doi: 10.1136/bmjopen-2021-053969.
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Pharmacol Res Perspect. 2018 Mar 2;6(2):e00387. doi: 10.1002/prp2.387. eCollection 2018 Apr.
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Patients' understanding of prescription drug label instructions in developing nations: The case of Saudi Arabia.发展中国家患者对处方药标签说明的理解:以沙特阿拉伯为例。
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