Drug Shortage In The U.S. Approach All-time High

Drug Shortage In The USA

Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels, said a report by the New York Times.

The report — “Drug Shortages Approach an All-Time High, Leading to Rationing — said on May 17, 2023:

“Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.

“Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.

“The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90% of domestic prescriptions.”

The report said:

“The Biden administration has assembled a team to find long-term solutions for shoring up the pharmaceutical supply chain, at a time when the United States remains heavily reliant on medicines and drug ingredients from India and China. And in recent weeks, generic drugmakers, supply-chain experts and patient advocates have appeared before lawmakers to discuss the problems.

“The scarcity of generic forms of chemotherapy to treat lung, breast, bladder and ovarian cancers has only heightened concerns.”

The report cited Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and a president-elect of the Society of Gynecologic Oncology: “This is, in my opinion, a public health emergency, because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now.”

The New York Times report said:

“The American Cancer Society last week warned that delays caused by the shortages could result in worse outcomes for patients.”

The report cited example of a patied:

“Ryan Dwars beat pancreatic cancer in 2021, but late last year a scan showed cancerous spots on his liver. Dwars, 39 and a father of two young girls, had hoped to receive his final four doses of chemotherapy in April.

“Then his doctor delivered stunning news: He didn’t make the cut of those given priority for the treatment.

“‘The light at the end of the tunnel was within sight,’ Dwars, a special-education teacher in Iowa City, said. ‘It made it even worse to be so close — and now this.’”

It said:

“The White House team working on the broader issue of long-standing drug supply breakdowns includes national security, economic and health officials, according to James McKinney, a spokesperson for the Food and Drug Administration. Bloomberg reported earlier on the White House involvement.”

The FDA has said it is seeking authority from Congress to get additional information about the drug manufacturing and supply chain.

But the agency has also expressed its concerns to the White House about severe financial strain in the generic drug industry — an economic problem that FDA officials say they are not suited to address.

The report cited Dr. Robert Califf, the FDA commissioner, who highlighted the agency’s views during recent appearances before Congress, saying officials can only plug so many holes. “We have got to fix the core economics if we are going to get this situation fixed,” Califf told a House panel on Thursday.

David Gaugh, the interim CEO of the Association for Accessible Medicines, which represents generic drugmakers, recalled warning FDA officials in an April meeting that the recent bankruptcy and shutdown of Akorn Pharmaceuticals would likely be followed by others.

“Shortages are on the rise. We’ve all seen that,” Gaugh said in an interview. “And it is likely going to get worse, not better, very soon.”

The report said:

“The competition for the contracts with those intermediaries pits U.S. manufacturers against those in India, where labor costs are far lower. When a generic drug company can’t get a contract for a medication, it tends to stop making it and might see already slim profits shrink.”

The report said:

“During a House hearing on the shortages Thursday, Anthony Sardella, a business research adviser at Washington University in St. Louis, said generic drug prices had fallen by about 50% since 2016. ‘But there is a high cost to low prices,’ Sardella said, noting that they may lead to cost cutting that can result in quality problems.”

It said:

“A recent case in point was Intas Pharmaceuticals, a company in India that makes three key chemotherapy drugs that are difficult to find: methotrexate, carboplatin and cisplatin, the drug Dwars needed. Intas temporarily suspended manufacturing of the drugs after the FDA found serious quality-control violations.

“During an unannounced visit to the Intas plant, FDA inspectors discovered a “truck full” of hundreds of plastic bags filled with torn and shredded documents, according to a report issued in December. One quality-control worker poured acid on torn records and stuffed them in a garbage bag, the report said.

“FDA inspectors pieced papers together and found quality control records for products bound for the United States, the report said. The agency cited a raft of other problems as well.

“To ease the supply disruption, the U.S. distributor for Intas, Accord Pharmaceuticals, said a handful of lots were tested by a third party, certified and released to the U.S. market. The treatments arranged by Bray that reached patients in Iowa were among them.

“The companies were working with the FDA to restart manufacturing for U.S. customers, a statement from Accord said.”

The report added:

“The Society of Gynecologic Oncology sent out a nationwide survey in recent weeks. In response, doctors in 35 states said they had little to no supply of key chemotherapy drugs, even at large cancer centers and teaching hospitals.

“Dr. Patrick Timmins, a partner of Women’s Cancer Care Associates in Albany, New York, said his practice ran out of some chemotherapy drugs last week, but still has 25 patients who need them. ‘Our patients are in a war, and what we’re doing is we’re taking their weapons away,’ Timmins said. “It is completely ridiculous that we can’t figure out a way, at least in the short run, to get our patients treated, and in the long run to solve these recurring problems.’”

The report added:

“Dr. Kevin Schulman, a professor at Stanford Medicine who has studied the generic drug industry, said he had urged the White House team to examine how much power the intermediary companies have in contracting with generic drugmakers. He said they demand rock-bottom prices, but unlike a customer-facing company like Apple that contracts with suppliers worldwide, the drug intermediaries face no accountability when shortages arise.

“Schulman said he had recommended expanded government contracting with the nonprofit Civica, which sells generic drugs at slightly inflated prices, which can help generic makers run a stable business. ‘The intermediaries are driving people out of the market,’ Schulman said. ‘I think it’s a market problem and we need market-level solutions.’”

CNN in a report — “Cancer drugs among top 5 most affected by shortages in the US” (https://edition.cnn.com/2023/05/11/health/chemo-drug-shortages/index.html) — said on May 11, 2023:

“As the US faces a near-record number of drug shortages, cancer treatments are among the hardest hit.

“There is an active shortage of about two dozen chemotherapy drugs, the fifth most of any drug category, according to data from the end of March from the University of Utah Drug Information Service.”

The report cited Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists: Unlike some other drugs that also rank among the top five categories for shortages, such as antimicrobials, there are not often alternatives for chemotherapy drugs. And the shortages are affecting treatment for a broad range of cancers. “One of the key predictors of how well a patient will respond to treatment is getting a full dose on the right schedule,” Ganio said. “So when we can’t give the drug because we just can’t get the drug, that’s heartbreaking.”

The CNN report said:

“Overall, data from the University of Utah shows that there were more than 300 drugs with an active shortage in the US at the end of March, including nearly 50 new shortages that accumulated in the first three months of the year.

“The last time active drug shortages – including both newly reported and ongoing – were this high was in 2014, the data shows.”

The CNN report said:

In a hearing Thursday of the Energy and Commerce Subcommittee on Health, FDA Commissioner Dr. Robert Califf said that the economic issues underlying drug shortages are “not in the purview of the FDA.” The FDA is “plugging holes in the dike,” he said, but it is difficult to motivate change when it is not profitable for drug companies.

“These drug shortages are becoming more prevalent due to a warped marketplace,” said Rep. Kathy Castor, D-Florida, ranking member on the subcommittee.

“The current haphazard approach of addressing crisis episode-by-episode is not working to give American families the certainty and the quality of care they need and deserve.”

“Each company does not know what the other company is doing because they are competing,” he said. “When there is a shortage in one company, we need to be able to coordinate across these people.”

Outside of the FDA, there is a small team of officials at the White House focused on bolstering drug supply chains and quality, a senior administration official confirmed to CNN. The team was first reported by Bloomberg News.

The report said:

“Blame aside, patients remain at the heart of the issue. ‘There is severe patient impact happening every day,’ said Laura Bray, founder of Angels for Change, an advocacy group focused on ending drug shortages. ‘We also cannot forget the emotional trauma that you’re putting on a family in medical crisis.’ She experienced it firsthand in 2019 when her 9-year-old daughter, Abby, could not get the drug needed to treat her leukemia because there was a shortage. Abby is doing well now, but 9 out of 10 oncologists say that drug shortages have led to patient harm, including death, said Bray, who was a witness at the Oversight hearing Thursday. ‘Patients deserve access to these medicines. The physicians and nurses and care team who are trying to solve these crises and save them deserve easy and equal access to these medicines.’”

Drug Shortage, A National Security Threat

Another report by the New York Times — “Rising Rate of Drug Shortages Is Framed as a National Security Threat” (https://www.nytimes.com/2023/03/22/health/drug-shortages.html) — said on March 22, 2023:

“An increase in shortages of inexpensive yet critical medications is forcing hospitals to make “horrible” choices and is amounting to a national security threat, according to a report and testimony at a Senate homeland security hearing on Wednesday.

“A report prepared for the hearing found that drug shortages increased by nearly 30 percent last year compared with 2021, with an average shortage lasting 18 months and some spanning 15 years. They include common antibiotics, anesthetics and sterile fluids used to keep intravenous drug tubes clean.

“The problems were pegged to economic drivers, an opaque supply chain and the fact that as much as 80 to 90 percent of certain products are made overseas, said Senator Gary Peters, a Democrat of Michigan and chairman of the Senate Committee on Homeland Security and Government Affairs. ‘Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security threats,’ Mr. Peters said. Dr. Andrew Shuman, a cancer surgeon in Michigan, told senators at the hearing that shortages in his field have come to “represent a tragedy that is happening in slow motion.”

The report said:

“A federal appeals court temporarily blocked a lower court decision that overturned the Affordable Care Act’s requirement that all health plans fully cover certain preventive health services.

“Patients are increasingly being offered special financing to cover medical treatments that, consumer advocates say, can turn out to be more costly than using conventional credit cards.

“Multibillion-dollar corporations, particularly giant health insurers, are buying up primary care practices at a rapid pace.”

The report cited Dr. Shuman, who holds leadership roles at the University of Michigan hospital system and the Veterans Affairs Ann Arbor Healthcare System, said one cheap and established cancer drug called etoposide was recently in scarce supply. He had to weigh which patients, young and old, with lung, brain and testicular cancer, should receive the limited number of doses. “As a doctor who has devoted my life to fighting cancer, it is hard to express how horrible that is,” Dr. Shuman said. The hospital pharmacist managed to stretch the supply on hand, but “our pharmacists should not be desperately trying to squeeze out a few last drops when a life may be on the line,” Dr. Shuman said.

The report said:

“One expert outlined the efforts of the U.S. Pharmacopeia, a nonprofit focused on a safe drug supply, to map the dynamics and causes of shortages. That group found that there is a higher risk of shortages for drugs with a low price, complex manufacturing process or quality problems marked by a history of recalls, said Vimala Raghavendran, vice president of informatics product development for the U.S.P.” Policymakers are “flying blind” when it comes to the sources of critical ingredients, often referred to as A.P.I., or active pharmaceutical ingredients, Ms. Raghavendran said.

The report added:

“While the Food and Drug Administration gets some data on those active ingredients, the agency acknowledged to Senate staff that the data was not kept in a usable format, but rather “buried in PDFs within individual drug applications,” the Senate report says.

“Erin Fox, an expert at the University of Utah who tracks drug shortages, said another gap in information was critical, as well: There is no data on drugmaker quality. Such information might be used to reward the most scrupulous suppliers and help them expand production. Yet while the F.D.A. “sees really clear quality differences between products and manufacturing sites,” the information is confidential and not available to drug buyers. “There’s really no incentive for one company to do a better job,” Dr. Fox said. “If one company did do a better job, we have no way of knowing that.” The matter deserves attention, she said: “Unlike other products, people’s lives are at stake.”

The report added:

“Dr. Shuman, the cancer surgeon, cited other troubling shortages, including of eye drops that “literally keep people from going blind that cost a few dollars a month.” He said patients with glaucoma who do not get the drops could be faced with surgery instead. Those critical but cheap treatments in short supply point to a need for incentives or subsidies to companies that make them, Dr. Shuman said, given that ‘drug pricing structures are not always reflective of their value to patients.’”

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