[2001年至2010年科特迪瓦药用警报汇总]

[Summarizing of medicinal alerts in Ivory Coast from 2001 till 2010].

作者信息

N'Guessan-Irié Amenan Geneviève, Yavo Jean-Claude, Guillaume Amari Antoine Serge, Yapi Ange Désiré

机构信息

Direction de la Pharmacie et du Médicament, Abidjan, Côte d'Ivoire.

出版信息

Therapie. 2012 May-Jun;67(3):251-6. doi: 10.2515/therapie/2012029. Epub 2012 Aug 9.

DOI:10.2515/therapie/2012029

PMID:22874492

Abstract

UNLABELLED

STUDY'S AIM: This study aims a more efficient follow-up of the safety of medicines with human usage on the Ivory Coast territory.

METHOD

The structure responsible for pharmacovigilance in Ivory Coast i.e. DPM listed the medicinal alerts from 2001 till 2010.

RESULTS

It emerges 237 medicinal alerts among which 145 stops of marketing, 55 withdrawals of lots, 33 information notes and 4 levying of suspension of medicines. These alerts result mainly from pharmaceutical companies (49%) and the French Drug Agency or ANSM (ex-Afssaps) (43%). They mainly concern drugs of infectious target (22%) and pneumology (18%) and their motivations are so much industrial with mainly commercial reasons (27%) as of pharmacovigilance dominated by unfavorable profit/risk connections.

CONCLUSION

These results constitute an important database for the survey of the medicines market in Ivory Coast and an additional motivation to accelerate the implementation of a real national center of pharmacovigilance.

摘要

未标注

研究目的：本研究旨在更有效地跟踪在科特迪瓦领土上用于人类的药品安全性。

方法

科特迪瓦负责药物警戒的机构即药品和药品安全司（DPM）列出了2001年至2010年的药品警报。

结果

共出现237起药品警报，其中145起停止销售、55起批次召回、33份信息通知以及4起药品暂停征收。这些警报主要来自制药公司（49%）和法国药品管理局或法国国家药品与健康产品安全局（前身为法国药物安全局）（43%）。它们主要涉及抗感染药物（22%）和肺病药物（18%），其动机既有主要出于商业原因的行业因素（27%），也有以不良效益/风险关联为主导的药物警戒因素。