Recently, 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. It may be occurred due to contaminations with other ingredients or the presence of adverse effects associated with medicine administration [1,2,3,4,5,6,7,8,9,10,11,12]. 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 (total no. cases, 80 with no deaths) caused by P. fluorescens contaminated heparinized saline intravenous flush syringes [13].
In 2017, the World Health Organization (WHO) agreed on definitions proposed to specify what may be classified as defective medicinal products. 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].
Although all these definitions may not incarcerate the wide range of substandard medicinal products including those that were expired, inactive, or improperly stored/transported [2]. These arguments in definitions further obscure global management and local regulation of counterfeits and point to the need for an internationally accepted definition of what constitutes a “counterfeit” medicine [2, 15,16,17].
In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) is the responsible firm of protecting the public health from the danger of medicinal product defects. The drug sector at SFDA is the department responsible for receiving and evaluating complaints about medicinal products. The SFDA was founded under the Council of Ministers in 2003 and launched in 2009, as an independent body corporate. The main objective for the SFDA is to ensure the safety of food and drug for humans and animals, as well as electronic medical instruments [18, 19].
The SFDA defines a drug with a quality defect “any drug with faulty manufacture, product deterioration, detection of falsification, non-compliance with the marketing authorization or product specification file, or any other serious quality problem” [20].
Drug alerts are released by the SDFA to the manufacturer, distributor, healthcare professional, and public, when a defective medicine is reported to threat patients’ safety. SFDA has several tools for delivering drug alerts to the public and to healthcare providers. All recalls are made available to the public via Saudi Drug Bulletin on SFDA’s website or posted on drug alerts and news page on SFDA website. Since 2017, there is an integrated site for drug recall, which opened an important communication tool with the public, healthcare providers, pharmacies, drug manufacturers, and distributors [19, 21,22,23,24]. When drug recalls are announced, public notification occurred to stop using this product and discard any unused amount and additionally, counseling the public what to do and the best alternative choice to maintain patient safety with an efficient safe drug.
In February 2019, SFDA inaugurated the electronic tracking system for pharmaceutical monitoring. Through this system, the authority aims to track pharmaceutical products electronically at all stages of production and consumption ensuring the availability of medicines and their safety, in cooperation with government and private hospitals, clinics and health centers, government and commercial warehouses dedicated to the import and storage of medicines, community pharmacies, and the final consumer of the drug. This monitoring system contributes to the reduction of the circulation of products with quality defect, the provision of medicines, and their location, in addition to achieving drug safety by stopping the circulation of withdrawn or suspended drugs [24].
This is the first review to study the drug recall in SA and initiate a collection of recall medication letters from the SFDA website. The aims of this study were to analyze and characterize drug alerts reported by the SFDA from Jan 2010 to Jan 2019, excluding herbal and/or cosmetic drugs. It also discusses the number of the drug recall per year, the major therapeutic drug recall class, the most pharmaceutical dosage form recalls, and the reasons for recalls.