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目的:分析我国药品生产企业药品不良反应(ADR)报告存在的突出问题并探讨相关对策,进一步健全我国ADR报告监测体系。方法:统计2009-2013年国家药品不良反应监测年度总结相关数据,并检索中文期刊全文数据库中关于药品生产企业ADR报告的相关文献资料,提取相关信息。结果:我国药品生产企业ADR报告的数量虽有提升,但报告的质量仍需提高;药品生产企业上报的主观能动性差,上报意识更是薄弱。结论:普及药品不良反应及其报告的重要意义,提高我国药品不良反应报告的质量,增强药品生产企业ADR报告主观能动性工作的开展仍需加强。
OBJECTIVE: To analyze the outstanding problems existing in the reports of adverse drug reaction (ADR) in Chinese pharmaceutical manufacturers and to explore relevant countermeasures so as to further improve the monitoring system of ADR in our country. Methods: The data of 2009-2013 National Adverse Drug Reaction Monitoring Summary were collected, and relevant literature data of ADR Report of Chinese Medicine Periodicals were retrieved from the Chinese Journal Full-text Database to extract relevant information. Results: Although the number of ADR reports in Chinese drug manufacturers increased, the quality of the reports still needed to be improved. The subjective initiative of drug manufacturers and the awareness of reporting were weaker. Conclusion: The importance of popularizing adverse drug reactions and their reports, improving the quality of adverse drug reactions reports in our country, and enhancing the subjective initiative of drug manufacturers in ADR should be further strengthened.