Due to complex structural problems, shortages continue. Take, for example, what the pandemic has made temporarily visible. The reality is that many American medicines are manufactured elsewhere at the end of long supply chains. In some cases, raw materials called Active Pharmaceutical Ingredients (APIs) are sourced offshore, mainly from India and China. In other countries, the entire drug product (raw materials mixed with other ingredients into the final product) is manufactured overseas by contract manufacturing organizations. said Michael Ganio, Clinical Pharmacist and Senior Director of Pharmacy Operations and Quality at ASHP. “Also, he could have three manufacturers all sourcing from the same API manufacturer. There is no transparency.”
Transparency could start to solve the problem. Anticipating shortages and building resilient systems that can mitigate their impact is a first step that requires more information. This is especially important because most of the shortages occur not among new blockbuster drugs, but among older drugs that are sold at a pittance. The supply of these medicines is most likely interrupted by contamination, machine failure, or other production problems. Because the FDA requires manufacturers to keep their production lines safe, but not to reinvest in equipment on a specific schedule to keep them going. Those lines are running. The business case for investing in legacy products is less attractive than for investing in high-return breakthrough products.
Advance warning of production line shutdowns due to material supply or manufacturing problems could help regulators balance the market. However, such disclosures would require companies to disclose proprietary information. “The free market is difficult to legislate, and most of the problems that need to be solved involve some element of the free market,” said his senior director of drug information at the University of Utah Health Care. , said Erin Fox, who leads the research team. Provide ASHP with information about the shortage.
Fox is also on a committee at the National Academy of Sciences, Engineering, and Medicine that recommended reform in a report last year. It calls for a series of actions by the federal government, including cutting out international trade agreements to keep the momentum going. He also proposes developing a federal rating system to score companies on their resilience plans and disclosures. (The quality rating system is also approved by the FDA report.)
For businesses, the National Academies report acknowledges that businesses should not be forced to disclose personal information and recommends incentives to persuade businesses to disclose information more aggressively, noting that sticks do not. We recommend candy instead. For example, these federal ratings can be used by healthcare organizations to justify paying slightly higher drug prices in return for transparency.
Hiring will be difficult. “We are constantly fighting drug prices,” he said. “So it’s not easy to go to his CFO or pharmacy director at the hospital and say, ‘I’m going to buy a product that costs a little more, but I think it’s a good investment.’”
But he notes that the labor shortage is already costing hospitals directly and indirectly hurting patient safety. His 2019 study by consulting firm Vizient estimated that U.S. hospitals spend an additional $359 million annually in staff time and overtime to deal with staffing shortages. That same year, Australian researchers found that the shortage harmed patients by longer waiting times for treatment, longer hospital stays, poorer response to alternative drugs, surgical complications, and in some cases, preventable death. We identified 38 studies that found that
Health professionals believe it’s worth addressing this challenge to avoid the chaos that dominates the system each time a shortage occurs. One Melissa Johnson said, “Each time we have to come up with a protocol for what to use instead.” What’s missing this week? Can you identify another source? Should I?
Maintaining the status quo means not tackling the problem and shifting the burden of drug shortages onto beleaguered pharmacists, sick children and panicked parents who have no choice but to wait.
