One of the more vexing and troubling public health policy issue that has plagued the US pharma industry, yet receiving less deserving public news coverage than other industry stories, has been the existence of chronic drug shortages since the turn of the 21st century. A drug shortage is defined in which the “total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.” While the annual number has dropped since the peak year of 2011, the issue of chronic drug shortages still persists, despite attempts by the FDA and federal legislation to remedy the problem. Drug shortages continue to be severe enough to potentially cause adverse effects on patients, changes in treatment that result in suboptimal care, and higher costs to the healthcare system.
This white paper will briefly address the following two questions related to chronic drug shortages in the US:
- What are the key reasons for and solutions to the existence of chronic drug shortages in the US?
- Is there a role for the application of pharmaceutical decision science analytics to help mitigate the problem of chronic drug shortages?
Dr. George A. Chressanthis is currently Principal Scientist at Axtria. He brings a unique combination of professional experiences into the analysis of strategic and operational issues affecting the biopharmaceutical industry.
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