In 2024, 323 US drugs were in short supply, affecting millions of patients.

Drug shortages persist, particularly affecting 32 chemotherapy and central nervous system stimulant drugs.

Half of treatment shortages last over two years, affecting around 500,000 patients, due to manufacturing, quality, and supply chain issues.

The FTC is probing middlemen over chemotherapy drug shortages affecting 2 million Americans with cancer annually.

In 2023, 93% of treatment centers reported a carboplatin shortage and 70% a cisplatin shortage, amid low wholesale prices that may have led drugmakers to reduce production.

The EU has been affected by drug shortages, with most countries reporting worsening shortages in 2022, relying on imported ingredients from China and India.

The EU plans to share medicines and start joint drug procurement in 2024 to address worsening shortages.

In the US, 111 drugs were out of stock as of 2021, with 80% of active ingredients manufactured overseas.

Production and quality issues, along with supply chain disruptions, contributed to US drug shortages in 2021.

Teva's reduced production led to shortages of generic drugs, including chemotherapy drugs, at over 1,100 hospitals.

US cancer centers reported shortages of carboplatin and cisplatin, affecting 72% and 59% of centers, respectively.

Hospital pharmacists report shortages of 309 drugs, with 99% of them experiencing shortages.

One-third of health systems delay care due to shortages, including a dozen cancer drugs like cisplatin, used by 10-20% of cancer patients.

The US medicine shortage increased by 30% in 2022, posing a national security threat, with an average duration of 18 months.

Economic factors and opaque supply chains contribute to shortages of cheap cancer drugs, often made in India and China, forcing hospitals to make difficult patient care choices.

The EU is facing a significant shortage of medicines, including antibiotics and pediatric drugs, with a 38% increase in Spain.

In 2024, 323 US drugs were in short supply, affecting millions of patients.

Title:

Content: General Supervision
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An Unexpected Catastrophe in the World ’ s Largest Country: The Complete Story of U.S. Drug Shortages
The deficit is at a record level.
According to data from the American Society of Health System Pharmacists and the University of Utah Drug Information Service, organizations began tracking drug shortages for the first time in 2001. Steady since 2021 – now reaching a record high of 323 drugs in the first three months of 2024.
Paul Abramowitz, CEO of the American Society of Health System Pharmacists, wrote in a blog post on Thursday: “It ’ s been a long time to end drug shortages, ” and wrote:“ All drug classes are vulnerable to shortages, some of the most worrisome shortages include sterile injectable generic drugs, including cancer chemotherapy drugs and emergency drugs stored in hospital vans and procedural areas. It is dangerous for doctors and patients. ”
In addition to the 32 chemotherapy drugs that are deficient, the five categories of drugs with the greatest deficiency include central nervous system stimulants, antimicrobials, hormonal agents, and intravenous fluids. [1] The Drug Deficiency Database maintained by the American Society of Health System Pharmacists and the University of Utah is based on voluntary reports from practitioners, patients, and others that have been confirmed by manufacturers. The U.S. drug is in short supply, because it captures broader effects on service providers and patients.
The crisis has lasted a year and a half.
More than half of the treatment shortages have lasted for more than two years, according to an analysis by health consultancy IQVIA, and the average shortage affects at least half a million patients, many of them elderly, according to the US Office of Health and Human Services under the Assistant Secretary for Planning and Evaluation, which shared its analysis with Congress in May.
Growing demand can play a role in drug shortages, as with the recent shortage of weight-loss drugs, but often manufacturing and quality problems, such as supply chain gaps and downtime, are the root cause. And varied.
But the American Society of Health System Pharmacists has “serious concerns ” about parts of this proposal, especially financial sanctions imposed on hospitals that lack the resources to comply with the recommendations, Abramowitz wrote:“ We all know that managing shortages is not enough and is not a sustainable solution to the worsening crisis, and there is still a lot of work to be done at the federal level to fix the root causes of drug shortages. ”
Why Shortage Occurs
Shortages can be caused by high demand, as with the recent shortage of weight-loss drugs, but this is not usually the main problem.
The FDA also blames manufacturing and quality problems, supply chain gaps, and downtime, and Dr. Emily Tucker, a drug shortage expert and an assistant professor of industrial engineering at Clemson University, says that when there is an indication of shortages, large health systems often also proactively place large orders, adding to the system ’ s stress.
“I don ’ t blame anyone.
“When I talk to all the stakeholders – whether it ’ s wholesalers, manufacturers, or the government – everyone wants this problem to end, ” she said.
Lack of transparency
Dr. Julie Grallo, chief medical officer and executive vice president of the American Society of Clinical Oncology, told the House Committee earlier that the shortage puts providers in a terrible position: “The drug shortage crisis is forcing providers to make impossible choices, and it is also hindering the development of new drugs. Health drugs are purchased only on a price basis, and manufacturers do not have to disclose the source of their acquisition of the ingredients.
The shortage of this generic chemical drug came due to the closure of one factory in India that manufactures the active ingredient after a surprise FDA inspection found “significant quality issues, ” says Jarallo:“ We didn ’ t know, and there was no transparency regarding the company ’ s supply of the majority of active pharmaceutical ingredients to all manufacturers across the board.
Knowing this in advance, we could have responded much faster, ” Dr. Steven Schundlemeyer, director of the PRIME Institute of the University of Minnesota School of Pharmacy, which focuses on economic and management issues, told the committee that as with defense contractors in the United States, New Zealand requires manufacturers to disclose their suppliers, and that information is required.
Easily accessible in the database.
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Drug shortages persist, particularly affecting 32 chemotherapy and central nervous system stimulant drugs.

Half of treatment shortages last over two years, affecting around 500,000 patients, due to manufacturing, quality, and supply chain issues.

The FTC is probing middlemen over chemotherapy drug shortages affecting 2 million Americans with cancer annually.

Title:

Content: |

FTC, US Health Dept Launch Probe Over Chemo Drug Shortages

The investigation is targeting so-called middlemen that broker deals between hospitals and pharmaceutical companies.

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Each year, roughly 2 million Americans are diagnosed with cancer, and for some, getting the proper treatment has become a very serious waiting game.

This week, the Federal Trade Commission and the US Department of Health jointly launched a probe seeking information on how middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be contributing to a lack of chemotherapies and other generic drugs.

The Cost of Cheap Drugs

While various cancer treatments have gone in and out of short supply for years, the problem became particularly acute in 2023. In May, a survey from the National Comprehensive Cancer Network found that 93% of treatment centers reported they were short on carboplatin and 70% reported they were short on cisplatin. Those two drugs are used together and are prescribed to 10% to 20% of cancer patients. Those shortage rates dropped in the fall, but still sat at uncomfortably high levels, with many patients experiencing longer wait times between chemo sessions.

Access to raw materials for making drugs and an increase in patients play a part in the shortages, but the FTC and the Health Department suspect the middlemen buying and selling the medications might be at the heart of the issue:

  • Hospital transactions for medications are controlled almost entirely by three GPOs — Vizient, Premier, and HealthTrust — that purchase drugs on behalf of health centers, and three wholesalers — AmerisourceBergen, Cardinal Health and McKesson — that supply 90% of the pharmaceuticals, The Wall Street Journal reported.
  • Doctors, drugmakers, and patient advocate groups have argued that because the three GPOs represent so many hospitals, they’re able to win extremely low prices from wholesalers. But the prices may be so low that some drugmakers slash production or stop making the drugs entirely if they feel they can no longer turn a profit.

“For years Americans have faced acute shortages of critical drugs, from chemotherapy to antibiotics, endangering patients,” said FTC Chair Lina Khan. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen.”

A Growing Concern: A short supply of cancer treatments isn’t a great development, especially with new evidence that the disease is on the rise among younger generations. Most cancer patients are 65 and older, but one study published in JAMA last summer found cancer rates among people 50 and younger are going up, mostly driven by women and people in their 30s.

In 2023, 93% of treatment centers reported a carboplatin shortage and 70% a cisplatin shortage, amid low wholesale prices that may have led drugmakers to reduce production.

The EU has been affected by drug shortages, with most countries reporting worsening shortages in 2022, relying on imported ingredients from China and India.

Title:

Content: Brussels is planning for EU countries to share vital medicines and take emergency measures to avoid a repeat of shortages that hit the bloc a year ago.

The European Commission is proposing a “voluntary solidarity mechanism” requested by France and Germany and an early warning system flagging when drugs become scarce, according to draft proposals seen by the Financial Times. If insufficient donors come forward, EU capitals will be allowed to tap into an EU-funded stockpile set up during the Covid-19 pandemic and take other emergency measures.

In December and January western countries suffered a shortage of antibiotics including penicillin and amoxicillin, and painkillers such as paracetamol, especially in medicines used by children.

Among the emergency measures floated to prevent a repeat of that crisis, the commission could allow the extension of a drug’s shelf life, fast track approvals of alternative suppliers and support production increases.

Brussels will also encourage joint procurement of drugs from 2024 and medicine swaps with countries in the southern hemisphere, where peak winter demand happens at a different time.

The commission will draw up guidance for national stockpiles in 2024 and establish a Critical Medicines Alliance bringing governments, industry and civil society together. The commission declined to comment.

Three-quarters of countries reported a worsening of drug shortages in 2022, according to an industry survey. EU manufacturing is heavily reliant on imported active pharmaceutical ingredients from China and India.

Rising demand and disruption to supply chains have been compounded by inflation hitting the production of generic drugs, which typically sell at much lower prices than branded versions.

France has been actively encouraging the reshoring of basic medicine supply, with a giant paracetamol factory set to open in the country next year.

The EU is discussing whether to provide more funding for domestic production.

The commission’s proposal is scheduled to be approved on October 25 and could still change. Initially non-binding, it could lead to a Critical Medicines Act, with Brussels drawing up a list of vital medicines by year-end.

The commission also urges member states and the European parliament to approve its overhaul of pharmaceutical legislation, put forward in April. It includes plans to take control of drug production in the event of a public health emergency, a requirement for stockholders to inform Brussels of supply levels and for manufacturers to give early warnings of shortages.

An analysis by the European Medicines Agency and the commission found that unless there is unexpected demand the EU should avoid an antibiotics shortage this year.

“The information available today suggests that — if demand in the coming winter season does not differ significantly from the demand of recent years — the supply to the EU of key antibiotics seems to generally match demand,” the analysis said.

“However, this depends strongly on the compliance of industry with their legal obligations to ensure supply and their ability to adapt.”

Copyright The Financial Times Limited 2023. All rights reserved.
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The EU plans to share medicines and start joint drug procurement in 2024 to address worsening shortages.

In the US, 111 drugs were out of stock as of 2021, with 80% of active ingredients manufactured overseas.

Title:

Content: US supply chain crisis continues, FDA points to 111 drug shortages
Global Social Hotspot 16: 35 2021 / 12 / 05
Share:
The supply chain crisis in the United States continues, and many goods are facing shortages.
The US media said that the US pharmacies have a number of critical prescription drugs in stock. The US Food and Drug Administration (FDA) pointed out that about 111 drugs are out of stock in the United States. The FDA stressed that it will continue to take measures to monitor the supply chain.
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The Federal Reserve warned on Wednesday that large parts of the United States had begun to be affected by supply chain disruptions and labor shortages last month.
According to the FDA website, 111 drugs are out of stock in the United States, including the heart disease drug digoxin injection, the chemical drug Dacarbazine and some antibiotics.
The authorities say there are many reasons for the shortage, including production problems, quality problems, drugs and even the suspension of production.
According to the FDA, about 80% of the manufacturers of active pharmaceutical ingredients are located overseas, and the manufacturers have provided the FDA with most of the drug shortage information.
The Administration will also work closely with these manufacturers to address the drug shortage.
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Long Island Newspaper Newsday quoted Tom D'Angelo, president of the New York State Association of Pharmacists, as saying the shipping of a large number of medicines, including those for common blood pressure and for the treatment of colds and flu, was blocked.
Because of supply chain problems, the owner of a New York drugstore said there were fewer brands for some drugs, including Ibuprofen.
The National Association of Community Pharmacists (NCPA) released a survey last month that found that most non-chain pharmacies are struggling to fill employee vacancies and cope with supply chain disruptions.
Sixty percent of pharmacies surveyed said they were dealing with supply chain disruptions, and nearly 70 percent said it was difficult to fill staff vacancies.
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Production and quality issues, along with supply chain disruptions, contributed to US drug shortages in 2021.

Teva's reduced production led to shortages of generic drugs, including chemotherapy drugs, at over 1,100 hospitals.

Title:

Content: International
International News
Dependent on foreign raw materials fluctuate, big pharmaceutical companies chase short-term profit loss production
The shortage of ADHD drugs is just the tip of the iceberg of the current drug shortage in the United States. According to the FDA, more than 135 drugs are in short supply, including chemotherapy drugs for cancer.
A survey released by the American Society of Health System Pharmacists (ASHP) in early August showed that one-third of the 1,100 hospitals surveyed had no prescription, delayed or reduced prescriptions due to drug shortages to meet the supply window.
Expert analysis, pharmaceutical companies to pursue short-term profit first business model, so that the production of life-saving drugs and demand out of line, drug shortage problem is difficult to improve.
Experts urge pharmaceutical companies to face social responsibility
Rita Numerof, a medical industry consultant, wrote in Forbes magazine that in order to reduce costs, US pharmaceutical companies have long relied on foreign suppliers such as China, India and Italy to import raw materials for the production of drugs, which is prone to fluctuations in supply. They are looking to develop drugs that are more likely to be used for long-term diseases.
Teva, a manufacturer of ADHD drugs and the world ’ s largest generic drug manufacturer, announced earlier that it would reduce the production of some generic drugs and focus on more profitable products. Rumelove warned that if pharmaceutical companies are unwilling to address their social responsibilities and strengthen supply risk management, public trust in the pharmaceutical industry will continue to weaken, and ultimately public health and safety will pay a heavy price.
Focus on the organization to accelerate the use of new generic drugs to increase production incentives
The American Association for Access to Medicines (AAM) released a report last month, saying that because of restrictions on the supply of generic drugs, the supply price of generic drugs is limited, and the return of investment in new drugs is not high. The situation.
(Forbes / DrugTopics)
(Global Hot Talk)
Related Words: Adderall Drug Shortage Attention Deficit and Hyperactivity Disorder (ADHD)
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US cancer centers reported shortages of carboplatin and cisplatin, affecting 72% and 59% of centers, respectively.

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Content: Advertisement

U.S. cancer centers report ongoing shortage of chemotherapy drugs

By Cara Murez, HealthDay News
In all, 72% of cancer centers surveyed reported a continued shortage of carboplatin. And 59% were still seeing a shortage of cisplatin. Photo by klbz/Pixabay

U.S. cancer centers continue to have shortages of commonly used chemotherapy drugs, a new survey shows, though the medications are not as scarce as they were last June.

The National Comprehensive Cancer Network (NCCN), a nonprofit alliance of leading cancer centers, surveyed its network in September.

In all, 72% of cancer centers surveyed reported a continued shortage of carboplatin. And 59% were still seeing a shortage of cisplatin.

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These two platinum-based generic chemotherapy medications are recommended for treating many different cancers. Overall, 86% of centers surveyed said they were short on at least one type of anti-cancer drug. A survey in June showed that 93% of cancer centers had a shortage of carboplatin, and 70% of cisplatin.

"Everyone with cancer should have access to the best possible treatment according to the latest evidence and expert consensus guidelines," said Dr. Robert Carlson, chief executive officer for NCCN.

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"Drug shortages aren't new, but the widespread impact makes this one particularly alarming. It is extremely concerning that this situation continues despite significant attention and effort over the past few months. We need enduring solutions in order to safeguard people with cancer and address any disparities in care," Carlson said in a NCCN news release. Twenty-nine of the NCCN's member institutions responded to the September survey. They include leading academic centers across the United States. The findings may not reflect additional challenges that smaller community practices serving rural and marginalized patients are experiencing. The centers surveyed were using strict waste management strategies, so nearly all were still able to provide the medications to all patients who needed them. Other medications in short supply included methotrexate, with 66% of centers reporting a shortage; 5-fluorouracil, with 55% falling short; fludarabine at 45%; and hydrocortisone at 41%.

"These drug shortages are the result of decades of systemic challenges," said Alyssa Schatz, NCCN's senior director of policy and advocacy. "We recognize that comprehensive solutions take time."

Schatz said the network appreciates those who have put forth proposals to improve investment in generics.

"At the same time, we have to acknowledge that the cancer drug shortage has been ongoing for months, which is unacceptable for anyone impacted by cancer today," Schatz said. "These new survey results remind us that we are still in an ongoing crisis and must respond with appropriate urgency."

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The organization is continuing to advocate for more supplies.

CNN recently reported that two other drugs used for cancer, vinblastine and dacarbazine, went into shortage in September.

"These drugs are particularly used to treat patients with Hodgkin's lymphoma. Hodgkin's lymphoma is probably one of the most curable types of cancers out there," Dr. Doug Hawkins of the Children's Oncology Group, a research organization, told CNN.

"The problem is never-ending. It is horrible," he added. "I mean, to say to a patient, 'we know how to treat your child, but we can't get the drugs,' and this is America, and it's 2023 -- it's crazy."

More information

The White House has more on strengthening the supply chain for cancer drugs.

Copyright © 2023 HealthDay. All rights reserved.

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Hospital pharmacists report shortages of 309 drugs, with 99% of them experiencing shortages.

Title:

Content: As drug shortage list grows, many hospitals face tough decisions on rationing care

More than half of hospital pharmacists are reporting a critical shortage of chemotherapy drugs and nearly all are reporting overall medicine supply gaps as prescription drug shortages near an all time high, according to a new survey.

Hospital pharmacists said drug shortages have forced 1 in 3 health systems to delay, cancel or ration care or switch to alternate drugs to continue to treat patients. And 99% are reporting some drug supply shortages, an American Society of Health-System Pharmacists survey of more than 1,000 pharmacists released Thursday found.

The organization reported shortages of 309 drugs, near the all-time high of 320 shortages in 2014. The scarcity of key drugs is prompting hospitals to find or substitute drugs and change treatment plans as needed.

“In some cases, there are no alternatives to the affected drugs, which puts patients at risk," ASHP Chief Executive Officer Paul W. Abramowitz said in a statement. "This issue requires quick action from Congress to address the underlying causes of shortages and ensure patients have the medications they need.”

Cancer drug shortages

In June, the Food and Drug Administration said it will temporarily allow overseas drug manufacturers to import some chemotherapy drugs.

The FDA allowed Qilu Pharmaceutical, a drug manufacturer in China, to import the injectable chemotherapy drug cisplatin in 50-milligram vials. Toronto pharmaceutical company Apotex Corp. will distribute the medication in the United States.

More than a dozen cancer drugs have been in shortage in recent months, including cisplatin and carboplatin, used to treat lung, breast, prostate and gynecologic cancers. The National Cancer Institute said cisplatin and similar drugs are prescribed for 10% to 20% of all cancer patients.

In June, the National Comprehensive Cancer Network released a survey of 27 academic cancer centers that found 93% reported shortages of carboplatin and 70% faced shortages of cisplatin.

When cancer hospitals face such shortages, they attempt to make sure there's enough medication for patients to finish the course of treatment, said Mike Ganio, ASHP's senior director of pharmacy practice and quality.

Cancer hospitals facing such shortages might change medications for new patients starting on chemotherapy, said Ganio, a former pharmacy manager at an academic cancer center.

"You try to keep that patient on the same regimen as much as you can, unless they're failing it for some reason, and then you would switch," Ganio said.

Steroids, hormonal drugs also in short supply

More than 1 in 5 hospital pharmacists also reported shortages for steroids, hormonal drugs and oral liquids such as lidocaine, ibuprofen and amoxicillin.

A smaller number of pharmacists said heart medications, emergency prefilled syringes and drugs used for intensive care unit patients were in short supply. Others reported shortages of attention deficit hyperactivity disorder medicines, antimicrobial drugs and injectable opioids.

In all, about two-thirds of pharmacists said the shortages were "moderately impactful," which means they are managing shortages but patients are affected.

Pharmacists are managing the shortages by offering therapeutic alternatives, buying different vial sizes or concentrations and rationing medicines.

This article originally appeared on USA TODAY: Survey: Drug shortages are widespread, hospitals ration care

One-third of health systems delay care due to shortages, including a dozen cancer drugs like cisplatin, used by 10-20% of cancer patients.

The US medicine shortage increased by 30% in 2022, posing a national security threat, with an average duration of 18 months.

Title:

Content: The New York Times Original
Continue reading Growing drug shortage in the United States has become a threat to national security
The shortage of medicines in the United States last year increased compared to 2021 by 30%, according to The New York Times.
However, the article notes that the growing shortage of inexpensive but critical drugs poses a national security threat to the United States.
The growing shortage of inexpensive but critical drugs poses a threat to U.S. national security and forces hospitals to make “terrible ” choices, writes The New York Times, citing a report prepared for hearings in the U.S. Senate.
According to this report, the shortage of medicines last year increased by almost 30% compared to 2021, with an average shortage of medicines observed for 18 months, and for some drugs – 15 years.
Among the drugs in short supply are conventional antibiotics and anesthetics, the article said.
Senator Gary Peters, a Democrat from Michigan and chairman of the Senate Committee on Homeland Security and Government Affairs, said that these problems are related to economic factors, an opaque supply chain and the fact that 80% to 90% of some products are made abroad.
“Taken together, these underlying causes not only raise serious concerns about ensuring proper patient care, but also pose a serious threat to national security, ” Peters said.
Dr. Andrew Schumann, an oncology surgeon from Michigan, told senators at the hearing that the shortage of drugs in his field is "a tragedy occurring in slow motion."
As Schumann noted, recently due to the shortage of one cheap, but well-proven cancer drug, he had to choose which patients will receive this drug.
The article notes that many of the cheapest drugs tend to be made in countries such as India and China, where they are inexpensive to manufacture.
However, this concentration of production capacity creates an additional level of vulnerability to problems such as natural disasters and political unrest, emphasizes The New York Times.
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Economic factors and opaque supply chains contribute to shortages of cheap cancer drugs, often made in India and China, forcing hospitals to make difficult patient care choices.

The EU is facing a significant shortage of medicines, including antibiotics and pediatric drugs, with a 38% increase in Spain.

Title:

Content: There is not enough medicine in the EU
19 January 2023, 05: 20
ASTANA.
KAZINFORM - The European Union is suffering from a shortage of medicines.
Deficiency of antibiotics, such as amoxicillin, drugs against colds, flu and other respiratory infections, as well as some drugs for children, reports MIA "Kazinform" with reference to euronews.com.
In most countries, the situation is considered critical, but since such goods from pharmacies do not disappear at all, citizens are not advised to make stocks.
Doctors note a weakening in the population of natural immunity due to protection against coronavirus such as social distancing.
The main reasons for the sharp increase in demand, which have been identified, is the high prevalence of respiratory diseases with a lack of production capacity.
As pharmaceutical issues are being addressed at the national level, Governments are already taking steps to overcome the shortage
These measures include the sale of generics and the replacement of requested medicines with similar ones.
In some countries, some formulations have been changed, for example, drugs are offered in the form of syrups instead of tablets, so that children are more willing to take them.
"Pediatric drugs are generally now less available in the form of conventional tablets," said Steffen Tierstrup, chief medical officer of the European Medicines Agency. "Therefore, where children are more ill, the need for pediatric drugs is higher than for adult drugs."
A recent study showed that the shortage of drugs in Spain increased by 38% over the year.
The decline in their production was affected by inflation, high energy prices, shortages of raw materials and the effects of the pandemic.
“We need diversification, ” said Ilaria Passarani, head of the EU Pharmaceutical Group.“ Of course, it would be useful to return to Europe the production of some critical materials, such as active ingredients.
But we can't return all the production of all the materials we use for drugs.
This entails problems such as the increase in pharmacy prices associated with the implementation of environmental laws, labor laws, which are not necessarily enforced in other regions. ”
In March, the European Commission will present a revised version of the EU pharmaceutical legislation, which will include stricter supply obligations, earlier notification of shortages and seizures of medicines, and better informing the public about available stocks.
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