Assessment And Control Of Risk Factors In Drug Circulation In Shenzhen

Research purposesThe purpose of this research is to understand the status of the risk of drug circulation in Shenzhen. Using risk factor assessment as the tool, we investigate the risk factors for drug circulation in Shenzhen. And assess risk factors for drug circulation status by risk matrix evaluation method. Finally, we try to give some advice to reduce the drug circulation risks.Subjects and Methods1.Subject of this Study:the risk of drug circulation in Shenzhen. In May 2014, we choose 73 people working in the Shenzhen pharmaceutical sector to proceed site investigation.2. Methods of this Study(1)Operational definitionInjuries:refers to the damage to health, including the damage caused by the loss of product quality (safety, efficacy, quality) or availability problems.Risk:a collection usually means the likelihood of injuries and its severity. Parameter to evaluate of the risks include the seriousness, possibility and predictability.Drugs circulation is the process between the factory to the hands of drug users. The circulation include pharmaceutical wholesale enterprises and drug retailers.The risk of Drugs circulation:The system of Quality Management has some defect, and it may cause Quality accident including management risk and hardware risk.(2)ToolsOn the basis of literature analysis and the latest version of the "pharmaceutical quality management specification" (GSP),we made the inquiry form" index system for assessment of safety risk factor in drug circulation safety risk factor".through expert evaluation and supervision of medicines in Shenzhen after research management system, to be perfect.(3)Quality ControlThis study was funded by the Shenzhen Municipal Drug Administration, consulting table design to statistical analyzes were carried out in accordance with the design issues. On the basis of literature survey, we can extensively collect the possible risk in drug circulation. After discussion and revision by experts from Drug Administration, we made inquiry form to rate risk level of drug production. Then we did the survey in drug regulatory system, and collect different views and suggestions.Finally we ensure the "Assessment index system of Shenzhen drug circulation safety risk factors" inquiry form.(4)Data Management and Analysis MethodsRecycling inquiry form unified number, using Epidata3.02 to establish a database, and verify the correct data into SPSS 15.0 statistical software for processing. Using descriptive statistical analysis and risk analysis matrix for data analysis and processing.Results1.Object of this survey is 73 people who working in the drug regulatory system in Shenzhen. We took 68 questionnaires back, the recovery rate was 93.15%, and the effectively copies ware 62, accounting for 91.18%.2.After gathering the questionnaires,we use risk assessment and quantitative classification matrix method to risk factors in the survey. We found that high level risk factors are mainly distributed in the following aspects:Among the pharmaceutical wholesale business, the high level risk factors are:I15,114,117,I20,E34,P46,P90,P78,P87,P89,P45.In the pharmaceutical retail enterprise, the high level risk factors are:Q95,Q93,I98,I97,E110,P130, P120,P113, P118,P131.3.According to the above survey findings, we can take the following measures to deal with the risk factors found in drug circulation. For the indicators of drug safety risk assessment system, we should change the traditional drug safety management, introduce risk management procedures and improve drug safety management. Various sectors including government, pharmaceutical sector, pharmaceutical distribution companies need to identify risks, take a variety of risk management techniques, improve the regulations and policies to control possible risk factors. Then establish the appropriate management system, set up a department in charge of drug safety risk management at the level of regulatory agencies, which responsible for coordinating drug safety risk management.Conclusion1."Assessment index system of Shenzhen drug circulation safety risk factors " inquiry form are accurate and complete. The inquiry form depart the circulation of drugs into pharmaceutical wholesale and retail business, which in line with the actual situation in Shenzhen.Risk factors were divided into four parts:quality management system; personnel and document managements; storage equipment; circulation process, it’s more complete and accurate.2.After an initial consultation by experts, and based on the GSP, we summarized 131 risk factors for drug circulation. Through using risk evaluation matrix to assess the risk of Shenzhen pharmaceutical distribution, we found 22 higher level risk factors, which should be focused on. While there are 9 risks that have low probability but great influence should be paid more attention.3.According to the assessment result, we gave 9 advises for the Drug management to invent and reduce the risk of drug circulation in Shenzhen.