|Ji'nan: take measures to pay close attention to the work of|
Since 2015, Shandong Province Jinan City adverse drug reactions and medical device adverse event monitoring center to take three measures to grasp the Yaoxie safety monitoring work, steadily enhance the quantity and quality of the report and to ensure the safety of the use of consumer pharmaceuticals, medical devices and cosmetics.
One is to improve the system, the management of the. The monitoring work as the protection of public administration with safe and effective mechanical an event to catch, to develop and improve the "Jinan City adverse drug reaction / medical device adverse event report quality evaluation system", the sudden mass of serious case report, death case report duty system "," adverse drug reactions monitoring and evaluation system "a series of system, to regulate the four monitoring work, the operation process and working standard of refinement, and continuously optimize the monitoring mechanism to ensure the successful completion of the tasks of the city monitoring target.
Two is a clear responsibility, grasp the implementation. To quantify the four monitoring, clear the specific responsibilities of each area, requiring all levels of monitoring agencies to monitor the work of the unit is responsible for monitoring. Downtown of adverse reaction monitoring system and monitoring post point of daily technical guidance and training on a regular basis, organize serious adverse reaction / incident investigation, collection, feedback and report ADR reporting and monitoring data, the maintenance and management of adverse reaction monitoring information network, and continuously improve the timeliness and the accuracy of the report.
Three is the quantitative indicators, focus. With the basic medicine, traditional Chinese medicine injections and high risk drugs as the monitoring focus, and actively carry out the monitoring of key varieties. Issued decomposition of monitoring targets as the basis, to carry out Yaoxie safety monitoring knowledge and the legal laws and regulations publicity activities, strengthen the daily supervision of the adverse drug reaction monitoring, the monitoring work included in of drug production and operation, using units daily supervision and management work, combined with the daily supervision and inspection. Joint counties (city) District Bureau regularly carry out inspection, supervision, informed each unit two goods a mechanical monitoring work carried out, to supervise the work of measures to implement, to ensure high quality completion of tasks.
Up to now, the city reported a total of 11401 cases of adverse reactions / events. Among them, reported adverse drug reactions reported 7833 cases, 3085 cases of medical device adverse event report; reported 136 cases of adverse reactions reported. Establish and improve the risk signal mining and early warning mechanisms, a total of 13 ADR (adverse drug reactions), MDR (medical device adverse events) serious cases and 3 aggregation signals were investigated and verified.