中国医院用药评价与分析
中國醫院用藥評價與分析
중국의원용약평개여분석
EVALUATION AND ANAL YSIS OF DRUG-USE IN HOSPITALS OF CHINA
2014年
12期
1150-1152
,共3页
药品说明书%信息缺陷%分析
藥品說明書%信息缺陷%分析
약품설명서%신식결함%분석
Package insert%Information defect%Analysis
目的：探讨药品说明书存在的问题，为药品说明书的修订与完善提供参考。方法：采用随机直抽样法，抽取扬州市第二人民（以下简称“我院”）常用的药品说明书，分析其科学性、完整性和时效性。结果：85份药品说明书中，有6份与2010年版《中华人民共和国药典·临床用药须知》的要求不一致；有3份药品说明书适应证与《国家基本药物临床应用指南》的要求不一致；有5种药品的说明书为同一种药品各厂家之间批准的内容不一致；有3份说明书中药品规格与实际用量不适合；有4份药品说明书中药理作用与适应证不相符；另外，还存在药理作用、适应证、用法与用量等项信息滞后现象，已不能满足临床需要。结论：某些药品说明书质量有待提高，国家食品药品监督管理总局应指定相关部门定期进行药品说明书的修订工作，以保证药品说明书的科学性、完整性和时效性，减少临床在用药时的困惑，促进临床用药的规范与合理。
目的：探討藥品說明書存在的問題，為藥品說明書的脩訂與完善提供參攷。方法：採用隨機直抽樣法，抽取颺州市第二人民（以下簡稱“我院”）常用的藥品說明書，分析其科學性、完整性和時效性。結果：85份藥品說明書中，有6份與2010年版《中華人民共和國藥典·臨床用藥鬚知》的要求不一緻；有3份藥品說明書適應證與《國傢基本藥物臨床應用指南》的要求不一緻；有5種藥品的說明書為同一種藥品各廠傢之間批準的內容不一緻；有3份說明書中藥品規格與實際用量不適閤；有4份藥品說明書中藥理作用與適應證不相符；另外，還存在藥理作用、適應證、用法與用量等項信息滯後現象，已不能滿足臨床需要。結論：某些藥品說明書質量有待提高，國傢食品藥品鑑督管理總跼應指定相關部門定期進行藥品說明書的脩訂工作，以保證藥品說明書的科學性、完整性和時效性，減少臨床在用藥時的睏惑，促進臨床用藥的規範與閤理。
목적：탐토약품설명서존재적문제，위약품설명서적수정여완선제공삼고。방법：채용수궤직추양법，추취양주시제이인민（이하간칭“아원”）상용적약품설명서，분석기과학성、완정성화시효성。결과：85빈약품설명서중，유6빈여2010년판《중화인민공화국약전·림상용약수지》적요구불일치；유3빈약품설명서괄응증여《국가기본약물림상응용지남》적요구불일치；유5충약품적설명서위동일충약품각엄가지간비준적내용불일치；유3빈설명서중약품규격여실제용량불괄합；유4빈약품설명서중약리작용여괄응증불상부；령외，환존재약리작용、괄응증、용법여용량등항신식체후현상，이불능만족림상수요。결론：모사약품설명서질량유대제고，국가식품약품감독관리총국응지정상관부문정기진행약품설명서적수정공작，이보증약품설명서적과학성、완정성화시효성，감소림상재용약시적곤혹，촉진림상용약적규범여합리。
OBJECTIVE:To analyze the problems existing in drug package inserts for reference of revision of drug package inserts. METHODS:The common package inserts inYangzhou Municipal Second People?s Hospital( hereinafter referred to as “our hospital”) were randomly selected for analysis regarding their scientificity, scientific integrity and chronergy. RESULTS:Of the 85 package inserts, 6 failed to comply with “Pharmacopoeia of the People?s Republic of China?Clinical Medication Instruction”(2010 edition) , 3 failed to comply with“Clinical Application Guide of National Essential Drugs” in indications;the labeled contents in 5 package inserts approved by different manufacturers for the same drug were inconsistent; the drug specifications in 3 package inserts dismatch the actual dosage; the pharmacological actions labeled in 4 package inserts were inconformity with the indications; moreover, there was information lag in items such as pharmacological action, indications, dosage and administration etc, failing to meet the clinical requirement. CONCLUSIONS: The quality of some drug package inserts remains to be improved. China Food and Drug Administration( CFDA) should designate the relevant departments to revise drug package inserts regularly to ensure the scientificity, integrity and chronergy of package inserts of drugs, reduce confusion in clinical drug use and promote standard and rational use of drugs.
