Shortages persisted due to complex structural problems. For example, a pandemic show for a short time: the fact that many American drugs are manufactured elsewhere, as of late long supply chain. In some cases, the raw materials, known as active pharmaceutical ingredients, or APIs, come from abroad, mainly India and China. Elsewhere, the entire drug—the raw material is mixed with other ingredients into a finished product—is manufactured abroad by a contract manufacturing organization. “It is possible that although there are three products on the market with three brands, they all come from the same place,” said Michael Ganio, clinical pharmacist and senior director of quality and pharmaceutical practice at ASHP. a base. “It is also possible that three manufacturers are all sourcing from the same API manufacturer. Transparency is nonexistent.”
Transparency can start to solve the problem. More information is a necessary first step to forecasting shortages and building a resilient system that can reduce their impact. This is especially important because most shortages are not among new blockbuster drugs, but in older ones that sell at low margins. The supply of such drugs is most likely to be disrupted by contamination, mechanical failure, or other manufacturing problems—because although the FDA requires manufacturers to keep production lines secure, they do not require them to reinvest in equipment on any particular schedule to keep the lines running. The business case for investing in a legacy product is far less compelling than a high-yielding breakout product.
Forewarning that a production line is about to shut down, due to material supply or production problems, can help regulators balance the market. But that kind of disclosure would require companies to disclose proprietary information. “It is difficult to legislate the free market, and most of the problems need to be solved,” said Erin Fox, senior director of drug information at the University of Utah Health Care College and leader of a research team. All decisions have some elements of the free market. provide information about shortages to ASHP.
Fox was also a member of a committee at the National Academy of Sciences, Engineering, and Medicine that proposed reform in a reported last year. It gives a series of reminders for federal actions, such as the expansion of the National Strategic Reserve, currently holding Anti-Biological Terrorism drugs and create international trade agreements to maintain an uninterrupted flow of raw materials. It also proposes developing a federal rating system to score companies on resilience planning and disclosure. (A quality rating system has been validated by an FDA report also.)
For companies, the National Academies report recommends carrots rather than sticks, acknowledging that companies cannot be forced to disclose personal information, and suggesting incentives to do so. persuade them to be more open-minded. Those federal ratings, for example, could be used by healthcare organizations to justify paying slightly higher drug prices’ as a reward for transparency.
Adoption will be a challenge. “We are constantly struggling with rising drug prices,” says Ganio. “So it’s not easy going to the hospital CFO or the director of pharmacy and saying, ‘Hey, we’re going to buy a product that’s a bit more expensive, but we think it’s a good investment.‘”
However, he pointed out that shortages have forced healthcare organizations to pay more, directly in labor costs and indirectly affecting patient safety. A 2019 study by consulting firm Vizient estimated that US hospitals spend an extra $359 million per year on staff time and overtime to deal with shortages. That same year, Australian researchers identified 38 studies found that shortages harm patients due to longer treatment wait times, longer hospitalizations, adverse reactions to alternative medicine, surgical complications, and in some cases preventable deaths Okay.
Healthcare workers think it’s worth it to tackle the challenge, to avoid the chaos that pervades their systems every time there’s a shortage. “Every time, we have to come up with a process for what we’re going to use,” says Melissa Johnson, professor of medicine at Duke University and president of the Society of Infectious Diseases Pharmacists. “We have nothing this week? Can we identify alternative sources? Do we have to pair our own?
Maintaining the status quo means not solving the problem and letting the burden of drug shortages fall on exhausted pharmacists—and sick children and panicked parents who can’t do anything else besides waiting.
