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Wednesday, December 06, 2023

Opinion | Why We’re Stuck in a Constant Cycle of Drug Shortages - The New York Times

America Is Having Yet Another Drug Shortage. Here’s Why It Keeps Happening.

Carl Godfrey

By Emily Tucker

"Dr. Tucker is an assistant professor of industrial engineering at Clemson University.

There’s been a bombardment of bad news for drug supplies. The American Society of Health-System Pharmacists found this summer that nearly all of the members it surveyed were experiencing drug shortages, which generally affect half a million Americans. Cancer patients have scrambled as supplies of chemotherapy drugs dwindle. Other shortages include antibiotics for treatable diseases, such as the only drug recommended for use during pregnancy to prevent congenital syphilis (a disease that is 11 times more common today than a decade ago), and A.D.H.D. medications, without which people struggle to function in their day-to-day lives. The toll on Americans is heavy.

Over half of the shortages documented this summer by health consulting firm IQVIA had persisted for more than two years. But even though drug shortages affect millions of Americans, policymakers and industry leaders have provided little to no long-term relief for people in need.

Shortages have occurred regularly since at least the early 2000s, when national tracking began. Hundreds of drugs, in every major therapeutic category, have been unavailable for some period. The average drug shortage lasts about 1.5 years. Even when substitute medications are available, they may be suboptimal (for example, deaths by septic shock rose by 10 percent during a 2011 shortage of the first-line medication, norepinephrine) or have spillover effects (such as possibly increasing the risk of antimicrobial resistance). In addition to harming patients, shortages have cost health systems billions of dollars in increased labor and substitute medications.

It is frustrating that this crisis has lasted decades despite a veritable mountain of research, including hundreds of scholarly investigations; 10 years of annual Food and Drug Administration reports; and several congressional hearings, including one as recently as this week. Many Americans are still forced to deal with drug shortages because our generic drug supply chains remain vulnerable to crashing. Any given manufacturing problem, mismatch in supply and demand, discontinuation or natural disaster can lead to a major shortage.

When there is the potential for a shortage, drug manufacturers are required to notify the F.D.A. at least six months in advance or as soon as possible if less lead time is available. Upon being notified, the F.D.A. is supposed to identify and push for alternative sources of drug production, or it may temporarily lower standards on quality so drugs can be made available faster. But crucially, the F.D.A. cannot require manufacturers to produce drugs.

Large hospital chains can readily monitor shortage risks and preemptively place large orders. This panic buying can wipe out inventory, and leave hospitals with fewer resources strapped since they may get notice of a drug shortage only when it’s too late. There is little penalty for over-ordering because unused drugs can often be returned. Some patients in dire need have to rely on nonprofits such as Angels for Change to coordinate with manufacturers, wholesalers and hospitals to secure small orders of emergency supply.

The combination of quality issues and panic buying is precisely what has produced shortages of two major chemotherapy drugs, carboplatin and cisplatin. An F.D.A. inspection last year revealed poor manufacturing practices at a plant that produced these cancer drugs. The manufacturer, Intas Pharmaceuticals, quickly stopped production at the plant. Though there are other manufacturers, panic buying by health providers led to hugely inflated orders, intensifying the supply problem.

The problem is that the generic drug system is built to be fragile. Manufacturers compete against one another for orders from price-conscious health care providers, cutting costs where they can to offer the lowest prices. This leads to a race to the bottom of minimum accepted standards, including a lack of investment in quality systems and limited redundancy.

The F.D.A. has stringent quality standards but has limited reach and is pressured to allow for flexibility whenever there is a risk of shortage. Based on my own conversations in the industry, I find that health care providers and the group purchasing organizations that negotiate contracts on their behalf are generally unwilling to pay more for drugs made on higher quality manufacturing lines or spend money to hold adequate inventory buffers.

Addressing the underlying fragility of our essential drug supply will take structural change and investments. While all industries must grapple with how to build resilient supply chains, the pharmaceutical industry is unique. The people who are most affected by supply chain vulnerabilities — patients — are also those with least say in the choice to buy from reliable manufacturers. When people buy cars, they may pay more based on company reputation, ratings by outside testers and reviews from other customers. In contrast, patients bear the harm of drug shortages, yet they cannot choose the manufacturers of their essential drugs nor evaluate their reliability.

Legislative action is the only real way to ensure the availability of essential medications. After 20 years of drug shortages, it seems clear that markets alone are not the solution. And there are a few specific ways Congress should address drug shortages.

The first is to ensure better quality drug manufacturing. Modernizing manufacturing facilities would make them more reliable and prevent shortages.

The second is to improve the adaptability of drug manufacturing itself. Manufacturers should be able to switch quickly to alternative facilities or to increase production when demand unexpectedly increases.

The last is to maintain buffer inventory of essential medications within our health care system. Having inventory available to allocate to those most in need during shortages would buy time for the system to adapt to supply disruptions or surges in demand.

Policies that address all three areas simultaneously, not just individually, are necessary to truly stem drug shortages. They could be enforced via mandates on essential drug manufacturers or by providing incentives for health systems to purchase from more resilient manufacturers. Increasing domestic manufacturing, part of what the Biden administration is pushing, is not a panacea; the plants must be high quality and have backup capacity in other locations. Increased transparency about the quality of drug facilities could also help stakeholders identify potential supply chain problems faster.

There is support on both sides of the aisle and from the White House for making changes that will address the drug shortage crisis, though there are disagreements on how to do so. Regardless of the mechanism, it will be important that policies seek to improve Americans’ access to medications. We have accepted the cheap deal of unreliable essential drug supply chains for too long, leaving patients in the lurch when shortages strike.

Patients should not have to settle for continued inaction. Prescribing a change to our essential drug supply chains could make all the difference for Americans in their hardest times.

Emily Tucker is an assistant professor of industrial engineering at Clemson University who researches drug shortages and supply chain resilience.

Source photograph by Kamal Iklil/Getty Images.

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Opinion | Why We’re Stuck in a Constant Cycle of Drug Shortages - The New York Times

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