完善我国医疗机构药品质量监管立法的建议

Legislative Suggestions on Improving Drug Quality Supervision of Medical Institutions in China

目的:为加强医疗机构的药品质量监管提供参考和依据。方法:从立法角度分析医疗机构药品质量监管存在的问题,提出加强我国医疗机构药品质量监管的对策及完善我国医疗机构药品质量监管的修法建议。结果与结论:目前,医疗机构药品质量监管存在药房设置缺乏强制性标准、药品常规监管多为形式监管、对医疗机构涉药违法行为的处罚过轻等监管手段有限等问题。为加强我国医疗机构药品质量监管,建议相关部门应制定医疗机构药房设置的强制性标准及增设审核环节、制定适用于全国的《药品使用质量管理规范》。在完善我国医疗机构药品质量监管法律时,可在《中华人民共和国药品管理法》《药品管理法实施条例》中增加相应条款,修改并完善《医疗机构管理条例》等下位法律法规,以加强对医疗机构药品质量的监管。

OBJECTIVE： To provide reference and basis for strengthening the drug quality supervision of medical institutions. METHODS： The problems about the drug quality supervision of the medical institutions were analyzed from the angle of legislation. Countermeasures for strengthening drug quality supervision of medical institutions in China as well as legislative suggestions on improving drug quality supervision of medical institutions in China were put forward. RESULTS ＆ CONCLUSIONS： At present, the existing problems about drug quality supervision in medical institutions include that pharmacy setting lack mandatory stan- dards; routine drug quality supervision is mainly the formal regulation; the punishment of drug related illegal behavior in medical institutions is too light, etc. To strengthen drug quality supervision of medical institutions in China, it is suggested that the government should establish the mandatory standards for medical institution pharmacy setting, add administrative inspections, and formu- late Good Using Practice applicable to the whole country. When perfecting the law of drug quality supervision in medical institutions in China, relevant provisions may be added in The Drug Administration Law of the PRC, Regulations for the Implementation of Drug Administration Law, and the subordinate laws and regulations of Management Regulation of Medical Institutions so as to strengthen drug quality supervision of medical institutions.