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If you’ve been following health headlines in recent months, you may have heard that many prescription drugs are in short supply. Yesterday, the New York Times ran a piece about the scarcity of ADHD medicines. Certain steroids have also been hard to find. But many of the headlines that caught my eye have focused on the lack of common chemotherapy drugs. For cancer patients, shortages could mean the difference between life and death.
Last week, the American Society of Health-System Pharmacists (ASHP) released the results of a member survey to assess the severity of these shortages. Drug shortages are nothing new, but results from more than 1,000 pharmacists suggest that the current crisis is particularly concerning. More than 99% of respondents, nearly all of them pharmacists who work for hospitals or health systems, reported that they were facing drug shortages. In some cases, shortages are annoying but manageable.
“We're talking about things that we can easily substitute for something else. Or we can provide a different dosage or a different route of administration,” says Michael Ganio, senior director of Pharmacy Practice and Quality at ASHP. But in this latest survey, nearly a third of respondents said that current shortages had forced their hospital to ration, delay, or cancel treatments or procedures. “That's significant,” he adds.
The current cancer drug crisis stems from an incident last fall. Many of the pharmaceuticals sold in the US are manufactured overseas. In November, the Food and Drug Administration toured one of those plants in India, a facility owned by Intas Pharmaceuticals. Inspectors observed numerous violations related to quality control and data integrity. As a result, the plant halted production. It was the first domino to fall in a chain that would lead to a nationwide shortage of cancer therapy drugs..
Before the shutdown, Intas produced about 50% of US’s supply of cisplatin, a common cancer drug used to treat testicular, ovarian, bladder, head and neck, lung, and cervical cancers. When the plant halted production, other manufacturers weren’t able to ramp up enough to avoid a shortfall. Manufacturers don’t have that kind of surge capacity. If a company consistently produces 10% of the market share, “what is their incentive to have capacity to produce 30 or 40%?” says Mariana Socal, a health policy researcher at the Johns Hopkins Bloomberg School of Public Health.
As cisplatin became scarce, oncologists switched to carboplatin, another common cancer therapy, which Intas also produced. With Intas no longer producing carboplatin and increasing demand, that medicine is now also in short supply. It was “like a ripple effect in the supply chain,” Socal says.
A survey of US cancer centers in May revealed that a whopping 93% were experiencing shortages of carboplatin.
The impact on patients has been profound. Some have gotten smaller doses. Others have had to skip or delay treatments. Some medical organizations are advising doctors to reserve cisplatin and carboplatin for patients who have a chance at a cure.
“This shortage will lead to people dying,” Ravi Rao, an oncologist at a cancer center in Fresno, California, told the New York Times. “There’s just no way around it. You cannot remove these lifesaving drugs and not have bad outcomes.”
Even if Intas comes back on line and the shortage eases, the system will still be vulnerable. Socal likens the drug manufacturing system to a person with a chronic illness. Flare-ups may come and go, but we “still have that chronic condition underlying all of our supply chain.”
Generic drugs are especially vulnerable to shortages because profits are so slim. Cisplatin and carboplatin both cost less than $25 a vial. “The free market is pushing for this race to the bottom,” Socal says. When prices—and therefore profits—are so low, manufacturers don’t have any incentive to invest in improving manufacturing practices for these drugs, which might include upgrading equipment, expanding capacity, and creating redundancies.
The same typically isn’t true for name-brand medications, which are still under patent and thus produced by a single company. “There's a lot of economic incentive to keep those production lines up and running.” Ganio says.
There are ways to blunt the impact of shortages. Better planning could help. Currently, drug shortages happen with very little warning and the market is forced to react. But AI could provide an early warning system for drug shortages to help manufacturers and pharmacies plan ahead. One supply chain management company, TraceLink, has developed a product designed to do just that. The tool uses real-time data from the supply chain to predict drug shortages and their duration. According to TraceLink, the system can provide predictions up to 90 days in advance with greater than 80% accuracy. Things like the Intas shutdown, however, might be difficult to predict. When FDA inspectors record violations, the agency doesn’t always make the findings publicly available in a timely manner, Ganio says. “An FDA inspection report or warning letter often lags by several months.”
Advanced manufacturing tech could also help curb shortages. That might include things like 3D printing of drugs, automated monitoring to identify equipment that might not be working properly, and continuous manufacturing rather than batch production, which is more efficient, but expensive to implement, Ganio says.
But these tech fixes won’t address the root of the problem. Generic manufacturers need more incentives to focus on quality, not just cost. “The only information that is [currently] available to anyone in the supply chain is the price,” Socal says. If drug purchasers had a metric related to quality—for example, higher grades for manufacturers that have never had quality issues, and lower grades for plants that have had manufacturing violations—they could incorporate that into their purchasing decisions. That might be something the FDA could help implement. The agency has been trying for years, in fact. Or purchasers themselves could require that companies disclose their ratings in their contracts.
None of the proposed fixes will be easy or simple, but they’re urgently needed. “Lives are at stake,” Socal says. “Public health in America is really depending on a working and dependable drug supply chain.”
Read more from Tech Review’s archive
Portable manufacturing systems could provide on demand meds in the event of a shortage, like a backup generator for the pharmaceutical industry, Mike Orcutt reported in 2016.
Back in 2013, Karen Weintraub wrote about the race between two Biotech giants to invent new ways to manufacture biological drugs.
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