Objective  To develop and validate a medication safety literacy scale for elderly patients with chronic diseases, and to provide evaluation criteria for the safe use of medication.

Methods  The initial 42-item scale was developed based on semi-structured interviews, preliminary research, and expert evaluation. Using a quota sampling approach, elderly patients with chronic diseases from selected counties (districts) in Gansu Province were recruited as study participants. They were randomly assigned to Sample 1 and Sample 2 in a ratio of 2∶5. Sample 1 was used for exploratory factor analysis (EFA) to refine the scale. Sample 2 was used for confirmatory factor analysis (CFA) and to assess the scale's reliability and validity.

Results  A total of 975 patients were included in the study, with 282 assigned to Sample  1. A total of 838 questionnaires of Sample 2 were distributed, and 693 valid questionnaires were collected (effectiveness rate of 82.7%). The EFA results from Sample 1 supported a 3-dimensional structure consisting of 7 factors: cognition (theory, practice; 9 items), beliefs (concerns, necessity; 10 items), and behavior (medication selection, use, and storage; 13 items), yielding a final 32-item formal scale. Based on Sample 2, the CFA indicated satisfactory model fit for each dimension: χ²/ df ratios were 3.027, 4.830, and 4.597; RMSEA values were 0.054, 0.074, and 0.072, respectively; AGFI values were 0.957, 0.925, and 0.912, respectively. The scale exhibited good average variance extracted (AVE) and composite reliability (CompR) (AVE>0.5, CompR>0.7), with each dimension being highly correlated with the overall scale, the correlation coefficients were 0.46–0.68, where the correlation coefficient for concern beliefs was -0.46 (P<0.01). The absolute values of the correlation coefficients between each item and its corresponding domain (0.52–0.78) (P<0.05), indicating good scale content validity index (I-CVI). The Cronbach's α coefficients for factors and dimensions range from 0.71 to 0.87, and the split-half reliability ranges from 0.73 to 0.89, indicating good scale reliability.

Conclusion  The developed medication safety literacy scale for elderly patients with chronic diseases is a valid instrument to assess medication safety literacy in this population and can be promoted to use.

1.徐世英, 李京洮. 我国少数民族人口数量及分布的新态势——基于第七次全国人口普查数据的解析[J]. 人口与经济, 2023, (3): 1-19. [Xu SY, Li JT. The new situation of the number and distribution for ethnic minority population in china: analysis based on the seventh national census bulletin[J]. Population & Economics, 2023, (3): 1-19.] DOI: 10.3969/j.issn.1000-4149.2023.00.019.

2.李佳俊妮. 新时期药品安全治理体系下的居民药品安全素养评价体系构建及实证研究[D]. 南昌: 南昌大学, 2022. DOI: 10.27232/d.cnki.gnchu.2022.001150.

3.Plaza-Zamora J, Legaz I, Osuna E, et al. Age and education as factors associated with medication literacy: a community pharmacy perspective[J]. BMC Geriatr, 2020, 20(1): 501. DOI: 10.1186/s12877-020-01881-5.

4.Yeh YC, Lin HW, Chang EH, et al. Development and validation of a Chinese medication literacy measure[J]. Health Expect, 2017, 20(6): 1296-1301. DOI: 10.1111/hex.12569.

5.Gentizon J, Hirt J, Jaques C, et al. Instruments assessing medication literacy in adult recipients of care: a systematic review of measurement properties[J]. Int J Nurs Stud, 2021, 113: 103785. DOI: 10.1016/j.ijnurstu.2020.103785.

6.郑凤, 钟竹青, 丁四清, 等. 药物素养评估量表的编译与评价[J]. 中南大学学报（医学版）, 2016, 41(11): 1226-1231. [Zheng F, Zhong ZQ, Ding SQ, et al. Modification and evaluation of assessment of medication literacy[J]. Journal of Central South University (Medical Science), 2016, 41(11): 1226-1231.] DOI: 10.11817/j.issn.1672-7347.2016.11.019.

7.中国药学会科技开发中心. 关于开展全国医药经济信息网科技传播创新工程2017年重点项目的通知（国药会科〔 2017〕14号）[EB/OL]. (2017-04-10) [2021-06-12]. http://www.sinopharmacy.com.cn/uploads/file1/20170411/14918968469 369.pdf.

8.Zhong Z, Shi S, Duan Y, et al. The development and psychometric assessment of Chinese medication literacy scale for hypertensive patients (C-MLSHP)[J]. Front Pharmacol, 2020, 11: 490. DOI: 10.3389/fphar.2020.00490.

9.Ma G, Luo A, Shen Z, et al. The status of medication literacy and associated factors of hypertensive patients in China: a cross-sectional study[J]. Intern Emerg Med, 2020, 15(3): 409-419. DOI: 10.1007/s11739-019-02187-0.

10.Shi S, Shen Z, Duan Y, et al. Association between medication literacy and medication adherence among patients with hypertension[J]. Front Pharmacol, 2019, 10: 822. DOI: 10.3389/fphar.2019.00822.

11.Shen Z, Shi S, Ding S, et al. Mediating effect of self-efficacy on the relationship between medication literacy and medication adherence among patients with hypertension[J]. Front Pharmacol, 2020, 11: 569092. DOI: 10.3389/fphar.2020.569092.

12.金晨阳, 杜莉, 张雨格, 等. 中老年女性骨健康素养问卷研制及信效度检验[J]. 复旦学报（医学版）, 2023, 50(4): 575-581, 599. [Jin CY, Du L, Zhang YG, et al. Reliability and validity of the bone health literacy questionnaire for middle-aged and elderly women[J]. Fudan University Journal of Medical Sciences, 2023, 50(4): 575-581, 599.] DOI: 10.3969/j.issn.1672-8467. 2023.04.014.

13.彭一航. 智能药物管理系统在养老机构老年人中的应用效果研究[D]. 重庆, 重庆医科大学, 2020. DOI: 10.27674/d.cnki.gcyku.2020.000291.

14.林彦君. 基于数据挖掘的老年人安全用药知信行研究[D]. 广州: 广东药科大学, 2018.

15.Kim SB, Kim KO, Jang BI, et al. Patients' beliefs and attitudes about their treatment for inflammatory bowel disease in Korea[J]. J Gastroenterol Hepatol, 2016, 31(3): 575-580. DOI: 10.1111/jgh.13155.

16.Cecil RL Handbook of psychological assessment, 4th ed[M]// Gerald G. How to develop an empirically based psychological test. India: Academic Press, 2019: 36-48. DOI: 10.1080/00273171.2019.1614898.

17.孙羽健, 周越, 戴雨, 等. 基于COSMIN指南对中国慢性疼痛患者恐动症评估工具的系统评价[J]. 数理医药学杂志, 2024, 37(6): 431-438. [Sun YJ, Zhou Y, Dai Y, et al. The assessment tools for kinesiophobia in Chinese patients with chronic pain based on the COSMIN guidelines: a systematic review[J]. Journal of Mathematical Medicine, 2024, 37(6): 431-438.] DOI: 10.12173/j.issn.1004-4337.202404077.

18.马向芹. 我国老年慢性病患者患病及用药状况研究[D]. 河南大学, 2015.

19.刘梅珠, 高慧源, 蔡太生, 等. 合成毒品成瘾者多维度健康量表的编制[J].中国心理卫生杂志, 2023, 37(8): 723-728. [Liu MZ, Gao HY, Cai TS, et al. Development of the multi-dimensional synthetic drug abuser scale[J]. Chinese Mental Health Journal, 2023, 37(8): 723-728.] DOI: 10.3969/j.issn.1000-6729.2023. 08.012.

20.张欣, 都丽萍, 李时雨, 等. 2011年版美国用药安全自评量表汉化及应用初测[J]. 中国医院药学杂志, 2017, 37(21): 2109-2112. [Zhang X, Du LP, Li SY, et al. Reliability and validity of the Chinese version of 2011 ISMP medication safety self assessment(R) for hospitals[J]. Chinese Journal of Hospital Pharmacy, 2017, 37(21): 2109-2112.] DOI: 10.13286/j.cnki.chinhosppharmacyj.2017.21.01.

21.中国共产党中央委员会. 中国共产党第十九届中央委员会第五次全体会议公报[EB/OL]. (2020-10-29) [2025-01-30]. https://www.mem.gov.cn/xw/ztzl/xxzl/202010/t20201030_371114.shtml.

22.余田健, 张静, 余雄杰, 等. 基于信息化的心血管慢病患者个体化用药指导构建与实践[J]. 药学前沿, 2025, 29(7): 1209-1214. [Yu TJ, Zhang J, Yu XJ, et al. Construction and practice of individualized medication guidance for cardiovascular chronic disease patients based on informatization[J]. Frontiers in Pharmaceutical Sciences, 2025, 29(7): 1209-1214.] DOI: 10.12173/j.issn.2097-4922.202503030.

23.林艳伟, 王婷仙, 倪进东. 老年人社会支持评价量表的汉化及信效度检验[J]. 中华疾病控制杂志, 2022, 26(7): 834-838, 861. [Lin YW, Wang TX, Ni JD. Reliability and validity of Chinese version of the social support appraisals scale for older people[J]. Chinese Journal of Disease Control & Prevention, 2022, 26(7): 834-838, 861.] DOI: 10.16462/j.cnki.zhjbkz.2022.07.015.

24.李妍, 敬丽君, 钟丽婷, 等. 农村留守老年人用药安全及医疗保障状况调研——以辽宁省建昌县为例[J]. 中国社会医学杂志, 2023, 40(1): 81-84. [Li Y, Jing LJ, Zhong LT, et al. Investigation and promotion path of medical security for rural left-behind old people: a case study on medication safety of rural left-behind elderly in Jianchang county, Liaoning province[J]. Chinese Journal of Social Medicine, 2023, 40(1): 81-84.] DOI: 10.3969/j.issn.1672-5625.2023.01.019.