| 王丽,张红.眼科超说明书用药现状及其影响因素分析[J].中国药事,2018,32(11):1562-1570 |
| 眼科超说明书用药现状及其影响因素分析 |
| Analysis of the Status of Off-label Prescription of Ophthalmology Department and the Influencing Factors |
| 投稿时间：2017-02-27 |
| DOI：10.16153/j.1002-7777.2018.11.017 |
| 中文关键词: 超说明书用药 眼科 合理用药 |
| 英文关键词: off-label prescription ophthalmology department rational drug use |
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| 中文摘要: |
| 目的：对我院2015年眼科住院患者超说明书用药现状及其影响因素进行回顾性调查，促进眼科临床合理用药。方法：从我院9个临床科室随机抽取2015年住院病历各100份，共计900份，抽查用药医嘱14324条，涉及药品152种。对病历中的用药医嘱逐条进行分析，判断是否超说明书及超说明书用药的类型，分析各年龄组、各类药品、各科室超说明书用药情况以及与患者年龄、性别、科室、医师级别的关系，采用Micromedex的Thomson分级系统进行超说明书用药的证据查询。结果：按患者、用药医嘱与药品品种计，超说明书用药发生率分别为78.67%、14.45%和17.11%。χ2检验结果表明，超说明书用药发生率最高的科室为白内障科（21.2%）和玻璃体视网膜科（20.59%），抗肿瘤药及免疫调节剂超说明书发生率最高（100%）。经查证，所抽查的2070项超说明书用药医嘱均有证据支持，其中证据构成比排名前两位的是专家共识（41.45%）和国际指南（37.39%）。超说明书用药的logistic多因素分析结果表明，患者科室和年龄的OR（95% CI）分别为0.96（0.941~0.980）和1.182（1.128~1.239）。结论：眼科超说明书用药的药物种类相对较少，相关影响因素为住院患者所在科室和年龄。为规避医师职业风险并为患者提供更多的治疗机会，超说明书用药需要提供循证医学证据，同时建议将合理的超说明书用药及时载入药品说明书。 |
| 英文摘要: |
| Objective: To conduct a retrospective investigation of the status of off-label prescription of ophthalmology department inpatients in 2015 in Shanxi Eye Hospital and analyze the influencing factors in order to promote the rational use of ophthalmic drugs. Methods: 900 inpatient medical records were randomly selected from 9 clinical departments (100 per department). 14324 prescriptions including 152 different drugs from the 900 medical records were analyzed one by one to determine whether or not the prescriptions were off-label and the categories of off-label. All different age groups, all kinds of drugs, all departments, as well as the relationship between off-label prescription and age, gender, department and the rank of doctors were analyzed. The evidence of off-label prescription was searched by using the Thomson grading system of Micromedex. Results: The rate of the off-label prescription was 78.67%, 14.45% and 17.11% respectively according to patients, prescriptions and drug categories. Chi-square test results showed that the highest incidence of off-label prescription occurred in Cataract department (21.2%) and Vitreous-retinopathy department (20.59%); the drugs with highest incidence of off-label prescription (100%) were anti-tumor drugs and immunomodulators. All 2070 randomly selected offlabel prescriptions were confirmed by evidence, of which the top two evidence were experts consensus (41.45%) and international guidelines (37.39%). Logistic multivariate analysis indicated the OR (95%CI) of department and age were 0.96 (0.941-0.980) and 1.182 (1.128-1.239) respectively. Conclusion: The categories of off-label prescription were relatively few in ophthalmology department and the relative factors were departments and age of patients. In order to avoid occupational risks of physicians and provide patients with more treatment opportunities, off-label prescriptions require evidence-based medical evidence and it is recommended that reasonable off-label prescriptions be timely added to the drug instruction. |
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