Abstract
BackgroundA 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.ResultsSFDA 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.ConclusionSubstandard 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.
Highlights
A new incidence of a substandard medicinal product is discovered weekly as stated by the World Health Organization (WHO) around the world
Drug alerts about recalled drugs were collected from the official Saudi Food and Drug Authority (SFDA) website through the section assigned for drug news and alerts, and the section assigned for drug recall which was launched in 2017
The following information was extracted from drug alerts: the name of the medicinal product, the name of the active ingredient(s), dosage form, strength, manufacturer; batch number affected; the date and recall reason; and the subsequent action taken by SFDA
Summary
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. An increase in records of medicinal recalls (prescribed and/or over the counter drugs) was reported worldwide. When a medicinal product is removed from the market, it is called drug recall. A drug recall is a significant tool that can decrease the morbidity and mortality due to problems in medicinal product manufacturing and distribution. This was evident in 2005 in the outbreak of bloodstream infections WHO indicates that medicinal products are to be denoted as substandard medical products “these are authorized medical products that fail to meet either their quality standards or specifications, or both,” whereas falsified medical products are “medicinal products that deliberately/ fraudulently misrepresent their identity, composition or source” [14]
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