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Medicine recalls in Saudi Arabia: a retrospective review of drug alerts (January 2010–January 2019)
Future Journal of Pharmaceutical Sciences ( IF 3.4 ) Pub Date : 2020-11-20 , DOI: 10.1186/s43094-020-00112-3
Bushra T. AlQuadeib , Iman M. Alfagih , Ameera H. Alnahdi , Shadia M. Alharbi , Rawan A. Al-ahmari

A new incidence of a substandard medicinal product is discovered weekly as stated by the World Health Organization (WHO) around the world. After discovering an incidence of a substandard medicinal product, a drug recall announced to remove the affected medicinal product from the market. Drug recalls in SaudiArabia (SA) are made by the Saudi Food and Drug Authority (SFDA) or the distributors of the drug when certain criteria are met. A retrospective study of drug recalls in SA was carried out. Data were collected through a website search of the SFDA for drug recalls since January 2010–January 2019. SFDA recalled 84 substandard medicinal products which related to 47 alert letters and 52 drugs. The number of drug recall reported by SFDA increased six-folds in 2018 than in 2010. The major frequent therapeutic class of drug recall was the antihypertensive drugs followed by the antibiotic drugs (27.7% and 10.8%, respectively). The majority of the recalls were tablets followed by parenteral dosage forms (58% and 25%, respectively). The major reasons for the drug recalls were due to contamination (32.14%) followed by non-compliance with manufacturer’s specifications (20.48%). Two manufacturers were accounted for 34.52% of all recalled drugs. Substandard medicinal products are considered as a serious problem in SA. Contamination was the main cause of drug recalls, which requires root investigation of causes and for strict protective tools to be applied by drug manufacturers.

中文翻译:

沙特阿拉伯的药品召回:毒品警示的回顾性回顾(2010年1月至2019年1月)

根据世界卫生组织(WHO)的报告,每周发现不合格药品的新发病率。在发现不合格药品的发病率后,召回药品,宣布将受影响的药品从市场上撤出。符合特定标准时,沙特阿拉伯食品药品管理局(SFDA)或该药品的分销商会在沙特阿拉伯(SA)召回药品。进行了对SA中药物召回的回顾性研究。自2010年1月至2019年1月,通过SFDA的网站搜索收集了有关药物召回的数据。SFDA召回了84种不合格药品,涉及47封警告信和52种药物。SFDA报告的药品召回数量在2018年比2010年增加了六倍。召回药物的主要常见治疗类别是降压药,其次是抗生素药(分别为27.7%和10.8%)。召回的大多数产品是片剂,其次是肠胃外剂型(分别为58%和25%)。召回毒品的主要原因是污染(32.14%),其次是不符合制造商的规范(20.48%)。两家制造商占所有召回药品的34.52%。在SA中,不合格的药品被认为是一个严重的问题。污染是药品召回的主要原因,这需要对原因进行根本调查,并要求药品制造商使用严格的保护工具。召回的大多数产品是片剂,其次是肠胃外剂型(分别为58%和25%)。召回毒品的主要原因是污染(32.14%),其次是不符合制造商的规范(20.48%)。两家制造商占所有召回药品的34.52%。在SA中,不合格的药品被认为是一个严重的问题。污染是药品召回的主要原因,这需要对原因进行根本调查,并要求药品制造商使用严格的保护工具。召回的大多数产品是片剂,其次是肠胃外剂型(分别为58%和25%)。召回毒品的主要原因是污染(32.14%),其次是不符合制造商的规范(20.48%)。两家制造商占所有召回药品的34.52%。在SA中,不合格的药品被认为是一个严重的问题。污染是药品召回的主要原因,这需要对原因进行根本调查,并要求药品制造商使用严格的保护工具。在SA中,不合格的药品被认为是一个严重的问题。污染是药品召回的主要原因,这需要对原因进行根本调查,并要求药品制造商使用严格的保护工具。在SA中,不合格的药品被认为是一个严重的问题。污染是药品召回的主要原因,这需要对原因进行根本调查,并要求药品制造商使用严格的保护工具。
更新日期:2020-11-21
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