Drug Shortages and Patient Harms

Abstract

What Is the Issue? Drug shortages are a global issue with complex dynamics. Shortages can occur because of disruption at any point along the drug supply chain. Several strategies are used in Canada to prevent or alleviate the effects of drug shortages, including mandatory reporting by drug manufacturers. An understanding of the amount and types of real or potential harms caused to patients can inform policy decisions around drug shortage management and prevention. What Did We Do? We searched for literature providing evidence on patient outcomes associated with supply chain disruptions of pharmaceuticals and vaccines. An information specialist conducted a search of peer-reviewed literature sources published between January 1, 2003, and September 13, 2023. Documents were excluded if the objective was to investigate the potential effects of a drug shortage in the absence of an actual drug shortage or if the outcomes were not direct patient harms. What Did We Find? One scoping review and 33 nonrandomized studies were identified that evaluated patient outcomes associated with supply chain disruptions of pharmaceuticals and vaccines. We identified a wide variety of drug classes experiencing shortages. The most frequently reported shortages were anesthetics, oncology drugs, vaccines, drugs for the treatment of COVID-19, antimicrobials, and small-volume parenteral solutions. Most of the included primary studies concluded that the replacement drug or protocol was a safe or acceptable alternative to the shortage drug. The subset of primary studies that concluded that the replacement drug or protocol was not a safe or acceptable alternative to the shortage drug reported worse outcomes in health system use (including length of hospital stay), adverse events, disease progression, and mortality. What Does This Mean? Drug shortages have the potential to cause harm to patients and some drug shortages may have a greater impact on patients than others. The ability to predict which drugs could cause the greatest harm during a supply disruption would be a great benefit for future planning. The diversity of drugs experiencing shortages and their associated harms emphasizes that decision-makers may need to take a case-by-case approach when developing policies meant to lessen the impact of drug shortages.