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英国的警示对爱尔兰综合医疗服务中避孕药具使用的影响。

Effect of the British warning on contraceptive use in the General Medical Service in Ireland.

作者信息

Williams D, Kelly A, Carvalho M, Feely J

机构信息

Department of Pharmacology and Therapeutics, Health, Trinity College, Dublin.

出版信息

Ir Med J. 1998 Dec;91(6):202-3.

Abstract

In October 1995 the UK Committee of Safety of Medicine (CSM) issued a warning about the safety (thromboembolic disease) of the third generation oral contraceptive steroids (OCS) recommending a switch to older agents except where women were intolerant of first and second generation OCS. Advice by the Irish regulatory authority (Irish Medicines Board) did not recommend such a switch. This pill scare lead to some UK users stopping OCS mid-cycle and a rise subsequently in abortions and pregnancies was noted. To determine whether local or UK advice was followed we obtained data from the General Medical Service (GMS) Scheme on the use of contraceptive steroids prescribed before and after the CSM's warning. The results show a clear shift from usage of the third generation OCS to the second generation OCS and norgestimate-containing OCS. We have also noted a marked fall in the overall use of the combined OCS, a trend that was noted in the U.K. It is clear that prescribers and pill users were influenced more by advice from the UK than by Irish regulatory authority. There is now a centralised European mechanism to licence drugs in the European Union (EU). We need to develop an EU perspective to issues of drug safety, as constituent nations are no longer isolated islands.

摘要

1995年10月,英国药品安全委员会(CSM)发布了关于第三代口服避孕药类固醇(OCS)安全性(血栓栓塞性疾病)的警告,建议改用旧剂型,除非女性对第一代和第二代OCS不耐受。爱尔兰监管机构(爱尔兰药品管理局)的建议并不推荐这种转换。这场药丸恐慌导致一些英国使用者在月经周期中期停用OCS,随后堕胎和怀孕的人数有所上升。为了确定人们遵循的是本地还是英国的建议,我们从综合医疗服务(GMS)计划中获取了CSM发出警告前后所开避孕类固醇药物使用情况的数据。结果显示,使用情况明显从第三代OCS转向第二代OCS以及含去氧孕烯的OCS。我们还注意到复方OCS的总体使用量显著下降,这一趋势在英国也有体现。显然,开处方者和药丸使用者受英国建议的影响比受爱尔兰监管机构的影响更大。目前在欧盟有一个集中的药品许可机制。由于成员国不再是孤立的岛屿,我们需要从欧盟的角度来审视药品安全问题。

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