湖北省农村地区药物销售量监测系统应用研究
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摘要
一、研究目的
1、了解湖北省农村地区居民自我药疗行为的基本情况、药店的基线信息、药物销售管理的现状及药店相关工作人员参与药物销售量监测的意愿性，探索在农村地区建立药物销售量监测系统的可行性；
2、构建药物销售量监测系统框架，并开发药物销售量监测电子信息系统；建立农村地区药物销售量监测系统，提高农村地区传染病早期预警的能力；
3、探索不同预警模型在药物销售量监测系统早期预警中的应用，挑选出药物销售量监测系统的最优模型，并确定模型的预警参数和预警界值；比较药物销售量监测与门诊病人监测的及时性，以评价药物销售量监测系统的早期预警能力。
二、研究方法
1、采用目的性抽样和分层随机抽样相结合的方法，开展居民自我药疗行为调查、药店基本情况调查和药店工作人员意愿性调查。采用自行设计调查表，由研究人员统一培训调查员后开展调查。
2、通过广泛的查阅文献和召开专家咨询会的方法，确定拟开展监测的对象、监测范围、监测时间、监测内容。采用专家咨询和历史数据回顾分析法，挑选居民常用药物为监测目标药物。根据构建的药物销售量监测系统框架，与瑞典FPX公司和复旦大学共同合作开发包含了药物销售量监测电子信息系统在内的综合监测系统(Intergrated Surveillance System, ISS系统)，并在湖北省潜江市、沙洋县2个县市开展监测研究。对2012年4月1日-2012年12月31日药物销售量监测系统中上报的数据质量和药物销售量变化趋势进行分析。
3、利用ISS系统收集的2012年4月1日-12月31日潜江市所有监测药店呼吸系统类药物的销售数据和监测医疗机构门诊病人中流感样病例的病例数，结合模拟数据的方法，评价移动平均模型、指数加权移动平均模型、累积和控制图法三种预警模型在药物销售量监测早期预警中的应用并优选最佳的预警模型和模型参数。利用相关性分析，计算不同延迟天数下呼吸系统类药物日销售量和流感样病例数的相关系数，比较药物销售量监测与门诊病人监测的及时性。
三、研究结果
1、超过60%的农村居民在患有较轻的症状时会首先选择自我药疗。100%的城区药店有电脑，网络普及率为82.35%。71.79%的镇级药店配备有电脑，网络普及率为48.72%。94.12%的城区药店和51.28%的镇级药店有电子药物销售管理系统。16.67%的药店工作人员表示电脑操作水平熟练，能运用各种办公软件，62.50%的调查对象能掌握基本的电脑操作。79.17%的调查对象认为开展药物销售量监测对传染病疫情监测和控制有意义，其中41.67%的认为很有意义。87.50%的调查对象表示愿意参与药物销售量监测的研究。调查对象不愿意参与项目的原因包括：担心药店的商业信息被泄露、参与项目研究工作量大、无相应技术设备、担心不能胜任项目工作、无奖励机制提高工作积极性及无相关政策支持等。
2、2012年4月1日至2012年12月31日期间，23家药店共上报103,780条记录，其中县级药店共上报59,855条记录。药店数据上报的总缺报率为1.69%，总零报率为1.94%，总实报率为96.38%，总及时上报率为86.18%。第一次一致性检查时，药店药物种类上报的一致率为63.19%，药物销售量上报的一致率为59.72%。第二次一致性检查时，药店药物种类上报的一致率为85.96%，药物销售量上报的一致率为79.21%。23家药店共报告药物销售量288,835.5个包装单位，平均每家药店每天销售药物51.5个包装单位。上报的药物主要以复方感冒药、止咳药和抗生素为主，其中复方感冒药占总药物销售量的比例超过40%。药物销售量趋势可见比较明显的季节波动。应用加权移动平均法对药物销售量数据进行调整，可以有效的消除周末、假日效应对销售数据的影响，降低药物销售量数据间的变异。
3、指数加权移动平均模型和累积和控制图C3方法应用于药物销售量监测早期预警效果更好。在最佳预警参数设置下，指数加权移动平均模型预警的灵敏度为100%，特异度为93.60%，约登指数为0.94。累积和控制图C3方法预警的灵敏度为100%，特异度为93.60%，约登指数最高为0.94。药物销售数据提前2天时与流感样病例数据相关性最好，提示药物销售量监测数据可以更早发出预警信号。
四、研究结论
1、农村地区已经基本具备了开展药物销售量监测的基础硬件设施，药店工作人员参与药物销售量监测意愿性较好，且具有一定的电脑操作水平，在农村地区开展药物销售量监测是可行的。
2、本研究在湖北省农村地区成功构建并实施了药物销售量监测系统，监测数据上报的完整性、及时性、准确率和一致率均较高，数据质量真实可靠，监测结果显示了药物销售量具有明显的季节波动，可应用于传染病暴发早期探测。
3、指数加权移动平均模型和累计和控制图C3方法更适用于药物销售量监测早期预警。药物销售量监测系统具有较高的及时性，可以比医疗机构门诊病人监测系统更早探测到异常信号。
五、创新点
1、首次在农村地区开展药物销售量监测系统的应用研究，探讨了在农村地区开展药物销售量监测的可行性，并成功构建和实施了农村地区药物销售量监测系统。
2、采用模拟数据的方法，评价了移动平均模型、指数加权移动平均模型、累积和控制图法等预警模型在药物销售量监测系统中的预警功效。
3、首次探讨了农村地区药物销售量监测系统早期预警的能力。
Objectives
1. To understand the status of self-medication behavior and attitude of people in rural areasof Hubei province, investigate the baseline information of pharmacies, the status of thedrug sales management and willingness of staffs in pharmacies for drug salessurveillance in rural areas of Hubei province, to explore the feasibility of theestablishment of drug sales surveillance system in rural areas.
2. To establish framework for drug sales surveillance system, develop an electronic drugsales surveillance system for infectious disease, establish a drug sales surveillancesystem in rural areas, and improve the early warning capacity of infectious diseases inthe rural areas.
3. To explore the most suitable early outbreak detection algorithms and its optimumthreshold for drug sales surveillance, compare the timeliness of drug sales data sourceand outpatient volume datasource in health centers, and evaluate the early warningcapacity of drug sales surveillance system for infectious diseases.
Methods
1. Purposively sample strategy and stratified sample strategy method was used in the study.Self-designed questionnaire was used to investigate the status of self-medication behavior and attitude of rural residents, basic information of pharmacies and pharmacystaffs’ willingness to participate the drug sales surveillance project.
2. Establishing the framework for durg sales surveillance system based on literature reviewand experts consulting meetings. Selecting the most common used drugs as surveillancedrugs by analyzing the historical sales data, and then developing the IntergartedSurveillance System (ISS system) which contains an electronic drug sales surveillancesystem cooperated with Fudan University and the FPX Company. Conducting drug salessurveillance in Qianjiang and Shayang county in Hubei province with the establishedsystem. Analyzed drug sales data reported in the ISS system from April1, to December31,2012.
3. Sales data of respiratory related drugs and influenza-like illness cases in Qianjiang wascollected by ISS system from April1, to December31,2012. Comparing the movingaverage method, exponentially weighted moving average method, and cumulative sumcontrol chart method with simulated data. Correlations between the daily sales data ofrespiratory related drug and daily outpatient volume of influenza-like illness casesvisited the health center was calculated in different time lags to compare the timelinessand evaluate the early warning capability of drug sales surveillance system.
Results
1. More than60%rural residents who suffered less severe symptoms would chooseself-medication immediately or after1-3days if there were no alleviation of symptoms.100%county pharmacies has computer, and82.35%of them have access to the internet.71.79%township pharmacies equipped with computers, the internet penetration ratewas48.72%.94.12%county pharmacies and51.28%township pharmacies hadelectronic drug sales management system.16.67%pharmacy staffs were skilled oncomputer operation and use a variety of office software,62.50%of them were on thegeneral level of computer operation.79.17%of them thought that carring out the drugsales surveillance was meaningful,41.67%of them thought it was very meaningful for infectious diseases surveillance and control.87.50%of them would like to participate inthe drug sales surveillance project. Reasons for dislike to participate in the projectincludes: worring about the leak of business information, involving heavy workload,lacking of technical equipment, difficulty to perform, fear of failing in the project work,lacking of bonus to support enthusiasm for work and related policies support.
2.103,780records had been reported by23pharmacies from April1st to December31st,2012.59,855of which were reported by county pharmacies. The total missing reportrate was1.69%, zero report rate was1.94%, incidence report rate was96.38%, timelyreport rate was86.18%. The consistency rates of categories and sales volume reportedin the first consistency check was63.19%and59.72%respectively. In the secondconsistency check, the rate was85.96%and79.21%respectively.288,835.5packingunits were reported,51.5packing units were reported per pharmacy per day on average.Compound cold medicines, cough suppressants and antibiotics were main categoriesreported in the system; compound cold medicines accounted more than40%of totaldrug sales volume.
3. The weighted moving average method and cumlative sum control chart-C3method ismore suitable for early warning applicated on drug sales surveillance system. With themost suitable parameters and thresholds, the sensitivity of moving average method was100%, the specificity was93.60%, and the Youden’s index was0.94, the sensitivity ofC3was100%, the specificity was93.60%, and the Youden’s index was0.94. The drugsales surveillance system could detect outbreak2days earlier than outpatientsurveillance in health centers.
Conclusions
1. The rural areas have the basic hardware facilities to carry out the drug sales surveillance,pharmacy staffs would like to participate in drug sales surveillance. Also they are able tooperate the computer. So, it is possible to carry out drug sales surveillance in rural areas.
2. The study successfully constructed and implemented a drug sales surveillance system in the rural areas of Hubei Province. The completeness, timeliness, accuracy andconsistency of reported data was higher, and the quality of data was reliable. It wasindicated that there were seasonal fluctuations on the trend of daily drug sales volume,the drug sales surveillance could be used for early detection of infectious diseaseoutbreaks.
3. The exponentially weighted moving average method and cumlative sum control chart-C3method is more suitable for early warning in drug sales surveillance system. Drug salessurveillance system has higher timeliness than outpatient surveillance in health centers.
Innovations
1. We firstly applied the drug sales surveillance system in rural area, study the feasibility ofdrug sales surveillance in rural areas, and established a drug sales surveillance system inrural Hubei successfully.
2. Assessed the moving average model, exponentially weighted moving average model andCUSUM control chart method in drug sales surveillance with simulated data.
3. Evaluate the early warning capacity of drug sales surveillance system in rural areas for thefirst time.
1、了解湖北省农村地区居民自我药疗行为的基本情况、药店的基线信息、药物销售管理的现状及药店相关工作人员参与药物销售量监测的意愿性，探索在农村地区建立药物销售量监测系统的可行性；
2、构建药物销售量监测系统框架，并开发药物销售量监测电子信息系统；建立农村地区药物销售量监测系统，提高农村地区传染病早期预警的能力；
3、探索不同预警模型在药物销售量监测系统早期预警中的应用，挑选出药物销售量监测系统的最优模型，并确定模型的预警参数和预警界值；比较药物销售量监测与门诊病人监测的及时性，以评价药物销售量监测系统的早期预警能力。
二、研究方法
1、采用目的性抽样和分层随机抽样相结合的方法，开展居民自我药疗行为调查、药店基本情况调查和药店工作人员意愿性调查。采用自行设计调查表，由研究人员统一培训调查员后开展调查。
2、通过广泛的查阅文献和召开专家咨询会的方法，确定拟开展监测的对象、监测范围、监测时间、监测内容。采用专家咨询和历史数据回顾分析法，挑选居民常用药物为监测目标药物。根据构建的药物销售量监测系统框架，与瑞典FPX公司和复旦大学共同合作开发包含了药物销售量监测电子信息系统在内的综合监测系统(Intergrated Surveillance System, ISS系统)，并在湖北省潜江市、沙洋县2个县市开展监测研究。对2012年4月1日-2012年12月31日药物销售量监测系统中上报的数据质量和药物销售量变化趋势进行分析。
3、利用ISS系统收集的2012年4月1日-12月31日潜江市所有监测药店呼吸系统类药物的销售数据和监测医疗机构门诊病人中流感样病例的病例数，结合模拟数据的方法，评价移动平均模型、指数加权移动平均模型、累积和控制图法三种预警模型在药物销售量监测早期预警中的应用并优选最佳的预警模型和模型参数。利用相关性分析，计算不同延迟天数下呼吸系统类药物日销售量和流感样病例数的相关系数，比较药物销售量监测与门诊病人监测的及时性。
三、研究结果
1、超过60%的农村居民在患有较轻的症状时会首先选择自我药疗。100%的城区药店有电脑，网络普及率为82.35%。71.79%的镇级药店配备有电脑，网络普及率为48.72%。94.12%的城区药店和51.28%的镇级药店有电子药物销售管理系统。16.67%的药店工作人员表示电脑操作水平熟练，能运用各种办公软件，62.50%的调查对象能掌握基本的电脑操作。79.17%的调查对象认为开展药物销售量监测对传染病疫情监测和控制有意义，其中41.67%的认为很有意义。87.50%的调查对象表示愿意参与药物销售量监测的研究。调查对象不愿意参与项目的原因包括：担心药店的商业信息被泄露、参与项目研究工作量大、无相应技术设备、担心不能胜任项目工作、无奖励机制提高工作积极性及无相关政策支持等。
2、2012年4月1日至2012年12月31日期间，23家药店共上报103,780条记录，其中县级药店共上报59,855条记录。药店数据上报的总缺报率为1.69%，总零报率为1.94%，总实报率为96.38%，总及时上报率为86.18%。第一次一致性检查时，药店药物种类上报的一致率为63.19%，药物销售量上报的一致率为59.72%。第二次一致性检查时，药店药物种类上报的一致率为85.96%，药物销售量上报的一致率为79.21%。23家药店共报告药物销售量288,835.5个包装单位，平均每家药店每天销售药物51.5个包装单位。上报的药物主要以复方感冒药、止咳药和抗生素为主，其中复方感冒药占总药物销售量的比例超过40%。药物销售量趋势可见比较明显的季节波动。应用加权移动平均法对药物销售量数据进行调整，可以有效的消除周末、假日效应对销售数据的影响，降低药物销售量数据间的变异。
3、指数加权移动平均模型和累积和控制图C3方法应用于药物销售量监测早期预警效果更好。在最佳预警参数设置下，指数加权移动平均模型预警的灵敏度为100%，特异度为93.60%，约登指数为0.94。累积和控制图C3方法预警的灵敏度为100%，特异度为93.60%，约登指数最高为0.94。药物销售数据提前2天时与流感样病例数据相关性最好，提示药物销售量监测数据可以更早发出预警信号。
四、研究结论
1、农村地区已经基本具备了开展药物销售量监测的基础硬件设施，药店工作人员参与药物销售量监测意愿性较好，且具有一定的电脑操作水平，在农村地区开展药物销售量监测是可行的。
2、本研究在湖北省农村地区成功构建并实施了药物销售量监测系统，监测数据上报的完整性、及时性、准确率和一致率均较高，数据质量真实可靠，监测结果显示了药物销售量具有明显的季节波动，可应用于传染病暴发早期探测。
3、指数加权移动平均模型和累计和控制图C3方法更适用于药物销售量监测早期预警。药物销售量监测系统具有较高的及时性，可以比医疗机构门诊病人监测系统更早探测到异常信号。
五、创新点
1、首次在农村地区开展药物销售量监测系统的应用研究，探讨了在农村地区开展药物销售量监测的可行性，并成功构建和实施了农村地区药物销售量监测系统。
2、采用模拟数据的方法，评价了移动平均模型、指数加权移动平均模型、累积和控制图法等预警模型在药物销售量监测系统中的预警功效。
3、首次探讨了农村地区药物销售量监测系统早期预警的能力。
Objectives
1. To understand the status of self-medication behavior and attitude of people in rural areasof Hubei province, investigate the baseline information of pharmacies, the status of thedrug sales management and willingness of staffs in pharmacies for drug salessurveillance in rural areas of Hubei province, to explore the feasibility of theestablishment of drug sales surveillance system in rural areas.
2. To establish framework for drug sales surveillance system, develop an electronic drugsales surveillance system for infectious disease, establish a drug sales surveillancesystem in rural areas, and improve the early warning capacity of infectious diseases inthe rural areas.
3. To explore the most suitable early outbreak detection algorithms and its optimumthreshold for drug sales surveillance, compare the timeliness of drug sales data sourceand outpatient volume datasource in health centers, and evaluate the early warningcapacity of drug sales surveillance system for infectious diseases.
Methods
1. Purposively sample strategy and stratified sample strategy method was used in the study.Self-designed questionnaire was used to investigate the status of self-medication behavior and attitude of rural residents, basic information of pharmacies and pharmacystaffs’ willingness to participate the drug sales surveillance project.
2. Establishing the framework for durg sales surveillance system based on literature reviewand experts consulting meetings. Selecting the most common used drugs as surveillancedrugs by analyzing the historical sales data, and then developing the IntergartedSurveillance System (ISS system) which contains an electronic drug sales surveillancesystem cooperated with Fudan University and the FPX Company. Conducting drug salessurveillance in Qianjiang and Shayang county in Hubei province with the establishedsystem. Analyzed drug sales data reported in the ISS system from April1, to December31,2012.
3. Sales data of respiratory related drugs and influenza-like illness cases in Qianjiang wascollected by ISS system from April1, to December31,2012. Comparing the movingaverage method, exponentially weighted moving average method, and cumulative sumcontrol chart method with simulated data. Correlations between the daily sales data ofrespiratory related drug and daily outpatient volume of influenza-like illness casesvisited the health center was calculated in different time lags to compare the timelinessand evaluate the early warning capability of drug sales surveillance system.
Results
1. More than60%rural residents who suffered less severe symptoms would chooseself-medication immediately or after1-3days if there were no alleviation of symptoms.100%county pharmacies has computer, and82.35%of them have access to the internet.71.79%township pharmacies equipped with computers, the internet penetration ratewas48.72%.94.12%county pharmacies and51.28%township pharmacies hadelectronic drug sales management system.16.67%pharmacy staffs were skilled oncomputer operation and use a variety of office software,62.50%of them were on thegeneral level of computer operation.79.17%of them thought that carring out the drugsales surveillance was meaningful,41.67%of them thought it was very meaningful for infectious diseases surveillance and control.87.50%of them would like to participate inthe drug sales surveillance project. Reasons for dislike to participate in the projectincludes: worring about the leak of business information, involving heavy workload,lacking of technical equipment, difficulty to perform, fear of failing in the project work,lacking of bonus to support enthusiasm for work and related policies support.
2.103,780records had been reported by23pharmacies from April1st to December31st,2012.59,855of which were reported by county pharmacies. The total missing reportrate was1.69%, zero report rate was1.94%, incidence report rate was96.38%, timelyreport rate was86.18%. The consistency rates of categories and sales volume reportedin the first consistency check was63.19%and59.72%respectively. In the secondconsistency check, the rate was85.96%and79.21%respectively.288,835.5packingunits were reported,51.5packing units were reported per pharmacy per day on average.Compound cold medicines, cough suppressants and antibiotics were main categoriesreported in the system; compound cold medicines accounted more than40%of totaldrug sales volume.
3. The weighted moving average method and cumlative sum control chart-C3method ismore suitable for early warning applicated on drug sales surveillance system. With themost suitable parameters and thresholds, the sensitivity of moving average method was100%, the specificity was93.60%, and the Youden’s index was0.94, the sensitivity ofC3was100%, the specificity was93.60%, and the Youden’s index was0.94. The drugsales surveillance system could detect outbreak2days earlier than outpatientsurveillance in health centers.
Conclusions
1. The rural areas have the basic hardware facilities to carry out the drug sales surveillance,pharmacy staffs would like to participate in drug sales surveillance. Also they are able tooperate the computer. So, it is possible to carry out drug sales surveillance in rural areas.
2. The study successfully constructed and implemented a drug sales surveillance system in the rural areas of Hubei Province. The completeness, timeliness, accuracy andconsistency of reported data was higher, and the quality of data was reliable. It wasindicated that there were seasonal fluctuations on the trend of daily drug sales volume,the drug sales surveillance could be used for early detection of infectious diseaseoutbreaks.
3. The exponentially weighted moving average method and cumlative sum control chart-C3method is more suitable for early warning in drug sales surveillance system. Drug salessurveillance system has higher timeliness than outpatient surveillance in health centers.
Innovations
1. We firstly applied the drug sales surveillance system in rural area, study the feasibility ofdrug sales surveillance in rural areas, and established a drug sales surveillance system inrural Hubei successfully.
2. Assessed the moving average model, exponentially weighted moving average model andCUSUM control chart method in drug sales surveillance with simulated data.
3. Evaluate the early warning capacity of drug sales surveillance system in rural areas for thefirst time.
引文
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