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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.
Manufacturers are exempt from this requirement in circumstances where they are unable to provide advanced notification of a shortage, such as unexpected contamination of their production line. When there is no advanced notification to the FDA or the supply chain, health systems are forced to respond reactively.
"Over the past decade, the number of active and ongoing shortages that require management by health systems has increased"
While drug inventory management software programs are available, their focus is to support quick analysis of the supply chain in order to rapidly identify clinical alternatives for medications in short supply. One example of this technology is OrbitalRx, which collects data from disparate sources and aggregates it into a centralized platform.
It provides insight into inventory levels and historical utilization. Once aggregated, the pharmacy team can streamline communication, decision making, and alternative medication procurement.
Additionally, this platform has the potential to inform consumers if a shortage is unique to an institution or region. Although the available technology solutions support shortage management workflow, there is not yet a solution focused on predictive modeling of drug shortages.
As predictive modeling has become more prevalent in sectors within and beyond healthcare, the UNC Health Department of Pharmacy has undertaken a project to develop a validated proactive drug inventory management model. At the onset of the COVID-19 pandemic, our team developed and validated a model to predict patient volumes and utilization of medications that were pertinent to COVID-19, as well as those with the highest odds of going on shortage.
While still in the early stages, we are applying a similar methodology in the development of a model intended to support proactive management of drug inventory in anticipation of drug shortages. This model will employ application of concepts such as odds ratio, medication utilization trends, and predicted patient volumes from the previous models outlined. The objective of this model is to utilize predictive analytics to proactively identify medications at high risk for supply disruption and subsequently mitigate risk to patient care, decrease waste, improve inventory management efficiency, and enhance our institution’s financial performance. We hope to establish a new precedence of drug shortage management through this project that can be expanded and shared with pharmacy departments throughout the nation.