Drug shortages pose a serious and growing challenge to clinical practice and patient care. Over the past decade, the number of active and ongoing shortages that require management by health systems has increased. The inability to procure medications results in pharmacy departments having to identify alternative drug therapies, potentially resulting in delayed treatment and scenarios where front-line physicians are tasked with ordering unfamiliar medications, increasing the risk of medication errors. Moreover, in some care settings, like oncology, modifying a treatment regimen can negatively impact patient outcomes or treatment success.
There are a variety of contributing factors that can result in drug shortages. Common causes include quality issues with manufacturing plants, shortage of raw materials, supply and demand problems, or discontinuation of a product by a manufacturer, which is often driven by business decisions. Additionally, a lack of transparency in the supply chain can cause shortages regionally, which can cascade to a nationwide shortage. With any of these reasons, drug manufacturers are required to notify the FDA at least 6 months prior to discontinuing manufacturing of their drug product.