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    Home > Active Ingredient News > Drugs Articles > Implement the main responsibility! Pharmaceutical companies, do not ignore the adverse drug reaction report!

    Implement the main responsibility! Pharmaceutical companies, do not ignore the adverse drug reaction report!

    • Last Update: 2018-03-27
    • Source: Internet
    • Author: User
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    [China Pharmaceutical network industry trends] a drug manual usually describes the adverse reactions or side effects of drugs, because when the drug effect is related to the body, in addition to the therapeutic effect, there will be some reactions that are not related to the therapeutic purpose of drugs, and will damage the human body Therefore, in order to ensure the drug safety of the people and manage the whole life cycle of products, pharmaceutical enterprises need to provide adverse drug reaction reports and implement the main responsibility of enterprises However, a recent data report has made the industry call on pharmaceutical enterprises to implement the main responsibility of enterprises and conduct risk monitoring and re evaluation of drug safety The author understands that Hubei Province has released the 2017 annual report on adverse drug reaction monitoring in Hubei Province The number of adverse drug reaction reports provided by drug manufacturers is rare, accounting for more than 400, only 0.7% of the total Not only in Hubei Province, but also in many provinces For example, Zhenjiang ADR monitoring center reviewed 3498 ADR reports in 2017, but drug manufacturers reported 9 ADR reports, accounting for only 0.26% of the total reported in the city In addition, in 2016, 1.43 million adverse drug reactions were reported nationwide, while about 20000 reports from pharmaceutical companies accounted for only 1.4% of the total Why is the proportion of adverse reactions reported by pharmaceutical companies so small? What problem does this reflect? In view of the small reporting rate of pharmaceutical companies, some experts say that, on the one hand, pharmaceutical companies do not pay attention subjectively and have concerns ideologically; on the other hand, the information collection of adverse reactions is a short board As the main person in charge, drug manufacturing enterprises monitor and report adverse reactions, which is not only the responsibility but also the need to strengthen drug safety management However, in reality, the situation is not satisfactory Some experts also say that there is a deeper reason why many pharmaceutical companies are reluctant to report adverse reactions They are worried that people will mistakenly think it is a drug quality problem due to the lack of relevant knowledge What's more, some media will also distort the adverse reactions and mislead the audience, which makes pharmaceutical companies dare not submit adverse reactions reports On the contrary, foreign ADR reports are mostly submitted by drug companies It is reported that 95% of adverse reactions or events in the United States are reported by multinational pharmaceutical companies Tang yuan, director of the drug production supervision department of Suzhou food and drug administration, said: "if drug manufacturers can actively participate in the adverse reaction report, not only can they actively monitor drug risks in time, avoid the expansion of adverse effects, but also take better responsibility for public health." In view of the adverse drug reaction report submitted by pharmaceutical enterprises, the industry calls on pharmaceutical enterprises to break the silence, actively implement the main responsibility, and further promote the adverse drug reaction report and monitoring work of the whole pharmaceutical industry in combination with the requirements of the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical medical devices In addition, the state and the government should also strengthen the legal management of adverse drug reactions The author has learned that China is in the process of revising relevant laws and regulations to improve the punishment for the concealment of adverse drug reactions At the same time, relevant departments will also increase the content of adverse reaction report in the inspection of drug manufacturers and link it with product re registration According to the expert: "before, it was mainly to check the quality of drugs, but now it is necessary to check whether there is any omission or concealment of adverse drug reactions If there is no report, it cannot be registered." In addition, some pharmaceutical companies are also taking practical actions Yichang humanwell Pharmaceutical Co., Ltd has revised the directions of analgin and other drugs to add adverse reactions It is reported that Yichang humanwell also established a drug safety committee in 2016, under which a drug safety monitoring office is set up to be responsible for the monitoring and reporting of adverse drug reactions For the problem of low reporting rate of adverse drug reactions submitted by pharmaceutical enterprises, pharmaceutical enterprises should strengthen the sense of responsibility of the main body, change the concept, improve the pharmaceutical environment, and effectively ensure the safety of drug use by the people; Relevant departments should also actively strengthen the awareness of adverse reaction reporting and monitoring of enterprises, promote enterprises to standardize the work of adverse reaction reporting and monitoring from the perspective of law, and reduce the quality and safety risks of source drugs.
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