| The surveillance of post-marketing safety of drugs is directly related to the safety of citizens, and it is also a priority which plays an important role in drug administration. Since the surveillance of post-marketing safety of drugs in china started relatively late and its mechanisms are far from perfect, there is much to be desired. Under such circumstances, in order to ensure the safety of our people, we must continue to learn from some advanced experiences of surveillance system of post-marketing safety of drugs from abroad, to carry out comparative studies and to provide scientific basis for the further improvement of surveillance system of post-marketing safety of drugs. The main purpose of this study is to compare the surveillance system of post-marketing safety of drugs at home with some main foreign countries and propose recommendations on it.Several research methods such as intelligence research, qualitative analysis of the document, systematic analysis, typical case analysis are integratively used in this article. The key contents of this study include:1. To introduce and define the concepts related to surveillance of drug safety, which include adverse drug reactions, adverse events, pharmacovigilance and drug safety. To compare these concepts in different countries and organizations, and to gain a deep insight into drug safety from its life cycle.2. To discuss the construction of surveillance system of post-marketing safety of drugs, according to some major drug injury incidents and carry out a generic summary on the research process of ADRs surveillance.3. In this study, the United States, the European Union and the United Kingdom are selected. In terms of the organizational system, surveillance process, regulations, the surveillance system of post-marketing safety of drugs in those countries are discussed according to the surveillance status quo of post-marketing safety of drugs while the current surveillance situation in our country and army is summarized.4. To make a comparative study on surveillance system of post-marketing safety of drugs at home and abroad by summing up the common surveillance system both in China and foreign countries and then comparing these surveillance system according to specific characteristics in various countries. The purpose is to discuss its internal regularity of development and to provide a basis for further researches of surveillance system of post-marketing safety of drugs in China.5. To discuss several important issues, such as the organizational system, laws and regulations, surveillance implementation, scientific research, information utilization, surveillance of traditional Chinese medicine, information communication and fund, which impact the development of surveillance system of post-marketing safety of drugs in our country and proposed relative countermeasures.The main conclusions of the study are:1. The building of surveillance system of post-marketing safety of drug is a complex, long-term and arduous process. The surveillance system in various countries was mostly built up after some major drug injury incidents. Then the consummation of such system is also a long-term process, which is followed by the emergency and settlement of safety issues.2. A centralized surveillance system supported by regional centres has been adopted by the U.S. the E.U, the U.K. and China. But they each have their own characteristics. In the U.S. surveillance system of drug safety, all the relevant administrative and professional work is completed by FDA. Field offices, district offices and workstations are set up in the U.S., and which are under the direct jurisdiction of FDA. But the field offices, district offices, as well as the workstations have no rights to execute administration and surveillance independently, and their function is to assist OSE monitoring drug safety. The organizational system in China is closer to the U.S. in the formation, but there are great differences in functions.3. The surveillance system of post-marketing safety of drugs are comparatively perfect in U.S., but there are also serious problems with the function of organization. Since the surveillance system of drug safety is a centralized system and all the relevant administrative and professional work are completed by FDA, the current situation will inevitably creates the dense distribution of institutions and staffs. In FDA, the post-marketing safety of drugs has always not been sufficiently supported yet. The decision-making process of post-marketing safety of drugs is complicated, overlapping and lacking in effectiveness and definite standards. The role of OSE is not clear and the commissioners are frequently replaced. In addition, there are deficiencies in communications during the decision-making process of surveillance of post-marketing safety of drugs.4. The construction of safety information database is a focal point of surveillance of post-marketing safety of drugs. The E.U. has stepped up the construction of EudraVigilance(a safety information database) since 2001. And presently, this database has become an indispensable data source of surveillance of post-marketing safety of drugs in the world. The U.K.'s Yellow Card System and GPRD database were set up earlier and it was a more advanced database of post-marketing safety of drugs that adopted a model of commercial management. The AERS database has also made a great improvement in 2003 after several years of multi-condemnations especially in data-digging. This improvement has perfected its function of analysis and arrangement of the database. In China, the ADRs surveillance network database has also experienced two large improvements in 2003 and 2008. And now, it has basically reached the advanced level in the world.5. The process surveillance of post-marketing safety of drugs in various countries is basically the same, but there are also some specific differences. The common process is firstly to build up an information database (AERS, EudraVigilance, Yellow Card System, etc.) of post-marketing of drug safety. Once safety issues occurred, some relevant departments collected, collated and analyzed relevant information, carried out epidemiological research and took appropriated surveillance measures after confirming these safety issues. The U.S., E.U. and the U.K. have basically adopted this surveillance process, while the surveillance process in China remains in the stage of collecting safety information data yet, so a further surveillance research is still needed.6. The surveillance system of post-marketing safety of drugs in China require a series of improvements in various aspects. The surveillance organizational system is a linear functional structure. In order to administer more effectively, the SFDA has to think over the scope of administration. In view of such a problem, a comprehensive vertical administration system is proposed to be adopted. The drug administration authorities in provinces, autonomous regions, municipalities and country-level cities should be directly under the administration of SFDA. In the area of the construction of surveillance laws system of post-marketing safety of drugs, the framework of surveillance laws in China are not perfect yet and most of the laws exist only theorectically, which should be further developed in detailed rules and regulations in order to guide the surveillance of post-marketing safety of drugs and achieved unity, standard and laws to go by in the end. With regard to the problem of indemnity in drug safety, corresponding levels of compensation should also be considered. In addition, poor enforcement of surveillance is an extremely complicated problem that needs to be solved immediately. At the same time, a series of scientific research on post-marketing safety of drugs should be strengthened in China, the utilization of safety information should be paid more attention to. The exchange and communication of safety information should be enhanced, and corresponding laws and regulations on safety surveillance of traditional Chinese medicines should be formulated. |
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