Evaluating Oncology Drug Shortages: Strengthening Active Pharmaceutical Ingredient Supply Chain Vulnerabilities in the United States

Abstract

Aims: This study seeks to identify the root causes of these shortages and evaluate the fragilities within the oncology supply chain that obstruct efforts to enhance drug availability. The United States is experiencing significant drug shortages that critically impact patient care, especially for oncology patients.    Study Design:  We utilized publicly accessible cross-sectional data on drug shortages documented by the US Food and Drug Administration between 2023 and 2024. Methodology: Descriptive statistics and bivariate correlational analysis were employed to examine drug availability and its associations across multiple influencing factors. These variables are the rationale behind shortages, current status, updates, and therapeutic classifications. Results: The most common reason for drug shortages is increased demand (12.1%), followed by a shortage of an active ingredient. While the proportion of drugs impacted by shortages is higher in non-oncology therapies, the estimated proportion of shortage remains significant in oncology medication (9.2%, p<0.001) The descriptive statistics indicate that complying with Good Manufacturing Practices (GMP) led to 92.3% of cases being unavailable. The shortage of an API contributed to 54.4% limited availability/supply and 39.2% unavailability. The oncology drugs are less likely to be with reported shortage causes. However, there is a moderate correlation to unresolved statuses(r = 0.358, p<0.001), as seen in the bivariate correlation. Conclusion: The persistent unavailability and limited supply of certain drug products underscore the systemic inefficiencies in the supply chain that necessitate targeted interventions. While oncology drugs comprise a smaller fraction of the overall drug shortages, their availability is crucial for promoting pharmaceutical care in cancer therapies. Shortage of active pharmaceutical ingredients and non-adherence to Good Manufacturing Practices significantly exacerbate the issue of drug unavailability. These demonstrated supply chain challenges persist, specifically for oncology therapies. Domesticated API productions and advanced technologies for routine inspection are potential strategies for overcoming the unavailability of oncology therapies.