医院门诊处方超说明书用药的调查分析

The survey and analysis of off-label drug use of outpatient prescriptions in one hospital

目的调查分析广州医科大学附属第四医院门诊处方超说明书用药情况。方法分层随机抽取该院2012年门诊处方，参照药品说明书的内容，采用频数、构成比、发生率等参数指标及X^2检验对超说明书用药情况进行统计分析。结果共抽取该医院门诊处方3000张，含用药记录8208条。按处方和用药记录统计，超说明书用药发生率分别为10．37％和4．33％。超说明书用药类型主要包括给药剂量（36．60％）、给药频次（24．14％）、年龄（18．57％）和适应证（15．92％）4种。超说明书用药记录发生率居前3位的门诊科室为消化内科（11．18％）、妇产科（7．95％）和儿科（5．36％）。超说明书用药记录构成比居前3位的药品依次为泮托拉唑钠肠溶片（18．59％）、戊酸雌二醇片（12．11％）、地氯雷他定分散片（8．45％）。儿童（2-〈12岁）和女性患者可能存在更高的超说明书用药风险（P〈0．05）；副高级、中级和初级职称医师处方的超说明书用药发生率和风险都明显高于正高级职称医师（P〈0．05）。结论该医院门诊处方的超说明书用药情况较普遍，这部分用药可能存在一定安全风险，建立健全超说明书用药规制十分必要且紧迫。

Objective To survey and analyze the situation of off-label drug use of outpatient prescriptions in the Fourth Affiliated Hospital of Guangzhou Medical University. Methods The outpatient prescriptions of the hospital in 2012 were investigated by stratified random sampling, and compared with the drug instructions, the parameter indexes including frequency, component ratio, incidence rate and X2 test were adopted to statistically analyze the situation of off-label drug use. Results A total of 3000 prescriptions with 8208 medication administration records were sampled, and the in- cidence rates of off-label drug use of prescriptions and records were 10.37% and 4.33% respectively. Administration dosage （36.60%）, administration frequency （24.14%）, age （18.57%） and indications （15.92%） were the top 4 types of off-label drug use. The top 3 departments with highest incidence rates of off-label drug use in outpatient were Deparm- tent of Gastroenterology （11.18%）, Deparmtent of Obstetrics and Gynecology （7.95%） and Deparmtent of Pediatrics （5.36%）. Pantoprazole Sodium Enteric-Coated Tablets （18.59%）, Estradiol Valerate Tabletes （12.11%）, Desloratadine Dispersible Tablets （8.45%） were the top 3 drugs with highest component ratios of the total off-label drug use. The chil- dren （2-〈12 years old ） and female patients might have higher risk factors of off -label drug use （P 〈 0.05）, and the in- cidence rate and risk of off-label drug use of the prescriptions prescribed by doctors with vice senior, intermediate and primary professional titles were significantly higher than those with senior professional title （P 〈 0.05）. Conclusion The off-label drug use of outpatient prescriptions is common in the hospital and there may exist some safety risks. It is vei＇y necessary and urgent for us to establish and improve its related regulations.