中华医院管理杂志
中華醫院管理雜誌
중화의원관리잡지
CHINESE JOURNAL OF HOSPITAL ADMINISTRATION
2013年
10期
775-779
,共5页
朱静辉%刘桂林%朱贤克%朱巧燕
硃靜輝%劉桂林%硃賢剋%硃巧燕
주정휘%류계림%주현극%주교연
药品不良反应%基层监测机构%医疗机构%药品生产经营企业
藥品不良反應%基層鑑測機構%醫療機構%藥品生產經營企業
약품불량반응%기층감측궤구%의료궤구%약품생산경영기업
Adverse drug reaction%Primary monitoring units%Medical institution%Drug makers and sellers
相对于美国、欧盟等发达国家和地区成熟的监测上报体系而言,我国基层药品不良反应报告和监测过于注重医疗机构的把关,地方基层药品不良反应监测体系应该逐步扩大监测上报的范围,在药品制造企业、药品连锁店、零售企业中形成完善的药品不良反应监测体系.此外,基层药品不良反应监测还存在经费和人员不足、城乡不平衡、报表缺陷等多种问题.建议采取的措施包括:注重药品制造企业、药品连锁店、零售企业的监测,提高基层药品不良反应的上报率;加大宣传力度,建立相应的监督和惩罚机制;完善各个上报主体的组织平台.
相對于美國、歐盟等髮達國傢和地區成熟的鑑測上報體繫而言,我國基層藥品不良反應報告和鑑測過于註重醫療機構的把關,地方基層藥品不良反應鑑測體繫應該逐步擴大鑑測上報的範圍,在藥品製造企業、藥品連鎖店、零售企業中形成完善的藥品不良反應鑑測體繫.此外,基層藥品不良反應鑑測還存在經費和人員不足、城鄉不平衡、報錶缺陷等多種問題.建議採取的措施包括:註重藥品製造企業、藥品連鎖店、零售企業的鑑測,提高基層藥品不良反應的上報率;加大宣傳力度,建立相應的鑑督和懲罰機製;完善各箇上報主體的組織平檯.
상대우미국、구맹등발체국가화지구성숙적감측상보체계이언,아국기층약품불량반응보고화감측과우주중의료궤구적파관,지방기층약품불량반응감측체계응해축보확대감측상보적범위,재약품제조기업、약품련쇄점、령수기업중형성완선적약품불량반응감측체계.차외,기층약품불량반응감측환존재경비화인원불족、성향불평형、보표결함등다충문제.건의채취적조시포괄:주중약품제조기업、약품련쇄점、령수기업적감측,제고기층약품불량반응적상보솔;가대선전력도,건립상응적감독화징벌궤제;완선각개상보주체적조직평태.
Compared to the mature monitoring and reporting system of ADRs in developed countries such as the USA and EU,medical institutions in China have played too much a role.Instead,local primary monitoring and reporting system of ADRs should expand their scope of monitoring and reporting,as drug makers,chain drugstores and retailers should develop an effective ADR monitor/report system as well.At present,such a primary system is plagued by insufficient budget and staff,imbalanced urban/rural layout and defective statements.Recommended measures include enhanced surveillance for drug makers,chain drugstores and retailers,for higher reporting ratio of ADRs at primary level; greater publicity and better monitoring and penalty mechanism; better platform for various organizations.