Patient health may be at risk as drug shortages become more widespread, research finds

Persistent drug shortages over the past decade may hamper Americans’ ability to access the medications they need, when they need them. The average drug shortage now lasts for three years, up from two years in 2020, according to a new report form U.S. Pharmacopeia.

“As we navigate the complex landscape of drug shortages, it is paramount to shift the market into a stable state,” said Anthony Lakavage, senior vice president for global external affairs for the independent organization. “Economic pressures, especially the very low prices that generics manufacturers recover for many medicines, along with contracts that are frequently broken, have left our generic medicine supply chain fragile. Unexpected shocks can break the system and disrupt the supply of quality medicines.”

Researchers used artificial intelligence and predictive analytics to identify four factors that can make drugs more vulnerable to shortages:

• Low prices. Drug products, commonly older generics, with low prices have a higher risk of shortage. Product discontinuation increased by 40% in one year, from 100 drug products in 2022 to 140 in 2023, suggesting that tightening margins forced manufacturers to leave the market.
• Manufacturing complexity. Drugs with higher manufacturing complexity, such as sterile injectables, are more vulnerable to shortage. Manufacturing complexity also can be seen in certain therapeutic classes, such as some antibiotics that require dedicated facilities and in certain active ingredients that require complex chemical synthesis.
• Geographic concentration. Drugs in which the active pharmaceutical ingredient and/or finished dose are made in a single or a few locations are more susceptible to shortage.
• Quality concerns. Quality-related issues that surface in regulatory agency inspection outcomes and manufacturer recalls also influence drug shortage risk, but these issues must be used along with other information to be meaningful.

Related: Senate drug shortage bill zeroes in on supply chain, would pay hospitals to ‘stockpile’

U.S. Pharmacopeia calls for market and policy solutions that address both short- and long-term needs and include risk-mitigation strategies; public and private investment and partnerships; payment reform to reward reliability; and manufacturing quality, coordination and accountability

“Quality comes at a price,” said Vimala Raghavendran, the organization’s vice president for informatics product development. “The economics of generic drugs often leave manufacturers with razor-thin margins, making it challenging to prioritize investment in modern machinery or to elevate standards of quality. Without sufficient profitability, the cycle of innovation and improvement becomes difficult to sustain.”