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欧盟药品的可及性:EURO - Medicines项目的成果

Availability of medicines in the European Union: results from the EURO-Medicines project.

作者信息

Folino-Gallo P, Walley T, Frolich J C, Carvajal A, Edwards I R

机构信息

EURO-Medicines project, Institute of Hygiene, Rome, Italy.

出版信息

Eur J Clin Pharmacol. 2001 Sep;57(6-7):441-6. doi: 10.1007/s002280100345.

DOI:10.1007/s002280100345
PMID:11699607
Abstract

OBJECTIVE

There is at present no comprehensive directory of medicines available in European countries. Such a directory would be valuable to policy analysts, clinicians, regulatory agencies, pharmaceutical companies and consumer groups. The aim of this project was to compile such a directory of all medicines marketed in each of the European Union member countries.

METHODS

Lists of medicines for each country, compiled from several national sources, classified by Anatomical-Chemical-Therapeutic (ATC) code. Census date was late 1998.

RESULTS

A comprehensive directory was created using data from 14 of the 15 European Union countries. Numbers of trade names and of active ingredients varied widely, from Germany with 18,554 and 1,973, respectively, to Denmark with 1,915 and 1,016, respectively. In individual therapeutic areas, there were variations in the numbers of active ingredients available: the least variation between countries was in antineoplastic medicines (ATC code L, maximum number available in any country 101, minimum 60) and wider variation in alimentary (ATC code A, maximum 256. minimum 103) or cardiovascular (ATC code C, maximum 269, minimum 112). Only 7% of all the active ingredients were available in all the countries studied. The Scandinavian countries had the greatest proportion of active ingredients (60%) available in all other countries. Each country had a number of active ingredients available only in that country Italy had the largest number of these.

CONCLUSIONS

The directory illustrates the wide variations in the availability of medicines across the European Union. The range of drugs available in each country represents differences in regulatory and market policies, as well as cultural and historic differences. This directory lends itself to many further analyses.

摘要

目的

目前尚无欧洲各国可用药品的综合目录。这样的目录对于政策分析师、临床医生、监管机构、制药公司和消费者团体都很有价值。本项目的目的是编制一份欧盟每个成员国市场上销售的所有药品的目录。

方法

从多个国家来源汇编每个国家的药品清单,并按解剖学 - 化学 - 治疗(ATC)代码分类。普查日期为1998年末。

结果

利用欧盟15个国家中14个国家的数据创建了一份综合目录。商品名和活性成分的数量差异很大,德国分别有18554个商品名和1973种活性成分,而丹麦分别为1915个商品名和1016种活性成分。在各个治疗领域,可用活性成分的数量存在差异:各国之间差异最小的是抗肿瘤药物(ATC代码L,任何国家的最大可用数量为101,最小为60),而在消化系统药物(ATC代码A,最大为256,最小为103)或心血管系统药物(ATC代码C,最大为269,最小为112)方面差异较大。在所研究的所有国家中,只有7%的活性成分在所有国家都有。斯堪的纳维亚国家在所有其他国家中可用活性成分的比例最高(60%)。每个国家都有一些仅在该国可用的活性成分,意大利的此类成分数量最多。

结论

该目录说明了欧盟各国药品供应情况的巨大差异。每个国家可用的药物范围代表了监管和市场政策的差异,以及文化和历史差异。该目录有助于进行许多进一步的分析。

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