U.S. drug shortages reached 323 in Q1 2024; over half lasted more than two years, affected at least 500,000 patients, and included sterile injectables, CNS stimulants, antimicrobials, hormonal agents, IV fluids, and 32 chemotherapy drugs.

In 2023–2024, cisplatin/carboplatin shortages affected care; FDA allowed imports, and hospitals used alternatives, rationed doses, and changed vial sizes.

The U.S. had a nationwide Adderall shortage driven by manufacturing delays and high demand.

Liquid amoxicillin had a national shortage as major manufacturers reported constrained supplies, mostly affecting oral liquids for children and adults.

The White House proposed $3.26–5.11 billion to address shortages of drugs like Ozempic and amoxicillin, alongside calls for more transparency, FDA authority, investment, and mandatory manufacturer disclosures.

A COVID-19 shutdown at a GE Healthcare plant caused a global iohexol shortage, forcing hospitals to postpone cancer treatments, delay or modify CT exams, and consider expanding U.S. manufacturing capacity.

The EU proposed a solidarity mechanism, joint procurement, stockpiles, a Critical Medicines Alliance, and enabled shelf-life extensions and domestic production to smooth distribution.

France logged 4,925 drug shortages in 2023, affecting 44% of the population in 2024; health groups sought transparency as EU reforms aimed to boost responsiveness with safety stocks and streamlined timelines.

The war in Ukraine disrupted pharmacy supplies and complicated cross-border shipments, affecting treatment continuity for patients.

Russia’s pharmacies faced shortages from failed tenders, procurement delays, and reliance on foreign substances, exacerbated by sanctions and price hikes.

In Egypt, patients suffered and died amid shortages of critical drugs like insulin and chemotherapy, worsened by raw-material and pricing issues.

Egyptian authorities sought to ensure availability through a hotline, imports, and inspections.

U.S. drug shortages reached 323 in Q1 2024; over half lasted more than two years, affected at least 500,000 patients, and included sterile injectables, CNS stimulants, antimicrobials, hormonal agents, IV fluids, and 32 chemotherapy drugs.

Title:

Content: General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
General Supervision
Elham Aboul Fath
Editor-in-Chief
Thank you for your patience.
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.
Related Topics

In 2023–2024, cisplatin/carboplatin shortages affected care; FDA allowed imports, and hospitals used alternatives, rationed doses, and changed vial sizes.

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

The U.S. had a nationwide Adderall shortage driven by manufacturing delays and high demand.

Title:

Content: Clara Pitts has always strived for perfection.

The 17-year-old Utah native has been named a 2023 National Merit Scholarship finalist. And she heads to Brigham Young University as a freshman this fall.

But despite all of her achievements, Clara has one thing weighing on her mind: What if she fails?

Clara was diagnosed with attention-deficit/hyperactivity disorder (ADHD) in 10th grade, during the summer of 2020, after months of digital schooling had started to take its toll.

"For the first time, I started struggling with getting my homework done [and] having a set schedule that I had to do myself," Clara said. "It was because of online school."

So along with her mother, Rebekah, she made the decision to try medication.

"I didn't realize just how much my ADHD was inhibiting me from acting the same way as all of my friends until I had that experience of leveling the playing field," Clara said.

By December 2020, Clara was prescribed 10 milligrams of Adderall, a formulation of amphetamine mixed salts, to be taken twice a day. Immediately, she noticed a difference.

"It seemed like the logical course of action, like something that shouldn't have been happening in my brain was being fixed," Clara said. "Naturally, my brain goes really, really fast, and I don't even notice it because it's what I've grown up with, and it's the only mind I've ever experienced. But once I started having a different experience mentally, I felt a lot calmer."

For the two years that followed, Clara was finally able to lead what she called a normal life, managing school, extracurricular activities and social life -- all with the help of Adderall.

But in October 2022, Clara's sense of calm was stripped away when the US Food and Drug Administration announced a shortage of Adderall and its generic counterparts.

"I hadn't heard anything about a shortage," she said. "I didn't really take it seriously at first until later that week -- maybe three or four days later -- when I started to hear news about the shortage, and it really started to sink in."

CNN first spoke with Clara and her mother, Rebekah, about a month after the FDA's announcement. At the time, Clara had eight Adderall pills left in her prescription bottle -- enough to last her four days.

"Initially, I was just very surprised when I tried to refill the prescription and they would not [refill it]," Rebekah says. "Very quickly, I went from surprised to afraid."

On October 24, Rebekah texted Clara the bad news. The shortage had finally affected them, and their pharmacy could not refill Clara's medication due to the shortage.

"They wouldn't put you on a waiting list," Rebekah texted her daughter. "I'm just sitting here crying because I can't get you these meds."

Rebekah says she called eight local pharmacies, and each one turned up empty.

"I felt really emotional about it in that first week or two ... like I had failed my child, even though it wasn't my fault," Rebekah said. "I felt scared for what that would mean for her as a senior."

Why is there a shortage?

The FDA announced a shortage of Adderall on October 12. The agency noted that it was in communication with all manufacturers of amphetamine mixed salts and that one of those companies, Teva, was "experiencing ongoing intermittent manufacturing delays." Although other manufacturers continued to produce the drug, the agency said, "there is not sufficient supply to continue to meet U.S. market demand through those producers."

Jim McKinney, a spokesperson for the agency, told CNN that the manufacturing delay has been resolved and that the shortage is now "demand-driven."

Data from the analytics and research company IQVIA shows that the demand for Adderall has risen nearly 27% in recent years, with prescriptions jumping from 35.5 million in 2019 to 45 million last year.

On its website, the FDA lists eight manufacturers that have reported Adderall shortages to the agency. The website lists the shortage reason for some versions of the drug, such as "demand increase" or "shortage of active ingredient," but for other versions, it just says "other" or lists no reason at all.

Each year, the Drug Enforcement Administration tracks and sets a limit on production of amphetamine, one of the key ingredients in Adderall. It says that for the past three years, manufacturers didn't expend all of the ingredients that were available for their use.

"DEA is committed to ensuring that all Americans can readily access needed medications," an agency spokesperson told CNN in a statement. "We are aware that the pharmaceutical industry is claiming that there is a quota shortage for the active ingredients in ADHD drugs. Based on DEA's information -- which is provided by drug manufacturers -- this is not true."

CNN reached out to the eight manufacturers that reported shortages to the FDA.

Teva Pharmaceuticals, Epic Pharma and Rhodes Pharmaceuticals did not respond. Alvogen, SpecGX and Sunrise Pharmaceutical declined to comment.

Sandoz said it had enough product to meet current customer orders. Lannett also said it had enough to meet current customer orders but added that it did not have enough to fulfill increased demand.

McKinney, the FDA spokesperson, said supply is increasing.

"The FDA recognizes the potential impact that reduced availability of certain products may have on health care providers and patients and is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products," he said.

McKinney clarified that although the FDA is working with manufacturers, the agency does not make drugs and "cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug."

Dr. Yoram Unguru, a pediatric hematologist and oncologist with joint faculty appointments at the Herman & Walter Samuelson Children's Hospital at Sinai and the Johns Hopkins Berman Institute of Bioethics, studies drug shortages.

He says a lack of transparency about details -- how big the shortage is and how much drug each company is making -- is hindering solutions.

"Pharmaceutical manufacturers are not required to disclose the reason for disrupted supply. Knowing the exact reason for a given shortage is always challenging," Unguru said. "It's really difficult to be able to anticipate and let alone come up with meaningful solutions if you don't know what the problem is."

The search for alternatives

Clara ultimately went without Adderall for two and half months as she coped with the stresses of senior year. She began taking a different ADHD medication, Vyvanse, in mid-January.

Rebekah says she hopes Adderall will be an option for Clara again one day, adding that she doesn't have the emotional stamina to keep searching for the medication.

"I would like her to have medication as an option and for it to be reliable, because college will probably be the hardest journey for her with ADHD."

Clara says that life without Adderall is like trying to see the world vividly while wearing smudged glasses.

"You go around with dirty glasses. You get used to it, and you don't realize that they're dirty. But when you clean them off, having that extra bit of clarity makes a world of difference."

The-CNN-Wire

™ & © 2023 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.

CNN's Raenu Charles and Janelle Chavez contributed to this report.

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Liquid amoxicillin had a national shortage as major manufacturers reported constrained supplies, mostly affecting oral liquids for children and adults.

Title:

Content: US low on amoxicillin

The infection antibiotic amoxicillin is in short supply among at least three drugmakers, according to the American Society of Health-System Pharmacists and Bloomberg

As of Oct. 20, 14 of London-based Hikma Pharmaceuticals' amoxicillin products and nine of Israel-based Teva Pharmaceuticals' supply are part of the national shortage, according to the ASHP's drug shortage website.

Amoxicillin comes in many forms — including capsules, powders and chewable tablets — but the most common type children take is the liquid form, which makes up at least 19 products that are part of the dearth.

Hikma's oral amoxicillin drugs are on allocation, meaning the drugmaker is curbing new orders to ensure it can meet current contracts. Teva told ASHP it expects its back-ordered products to return to normal supply levels between late October and early December.

Novartis' Sandoz business also has a lack of the antibiotic because of "significant" demand, a company spokesperson told Bloomberg

Hikma, Teva and Sandoz account for three of four top manufacturers of the drug, according to Bloomberg. There are other antibiotics available, but the CDC recommends amoxicillin as a "first-line therapy" for multiple common pediatric infections.

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The White House proposed $3.26–5.11 billion to address shortages of drugs like Ozempic and amoxicillin, alongside calls for more transparency, FDA authority, investment, and mandatory manufacturer disclosures.

Title:

Content: Meitu
The first quarter of the United States serious drug shortage 323 drugs urgent cancer patients also have to be diverted and rationed!
CHU HENG NETWORK NEWS CENTER 2024-04-16 10: 42
According to the latest data from the American Society of Health System Pharmacists (ASHP) and the Utah Center for Drug Information Services, a total of 323 drugs in the United States were in severe shortages in the first quarter of this year, surpassing the record of 320 in 2014.
Among the drugs affected are the widely used diabetes drugs Ozempic and Mounjaro, the allergy treatment drug adrenaline, the common antibiotic amoxicillin for children, chemotherapy drugs and injections commonly used in hospitals in intensive care.
ASHP CEO Paul Abramowitz said in a statement that almost all categories of drugs are facing shortages, with non-patented sterile injectable drugs, including cancer chemotherapy drugs, and emergency drugs stored in hospital emergency vans and operating areas, the shortage of such drugs is the most worrying.
According to the American Cancer Society, chemotherapy is one of the top five drugs most affected by the shortage, which threatens to have a devastating impact on patients, and some hospitals and clinics say doctors have had to divert patients to ration their medications because of a shortage of some chemotherapy drugs.
In addition, ASHP noted that the continued nationwide shortage of ADHD drugs is “a problem for clinicians and patients. ”
The shortage of popular drugs is even more acute, with Mounjaro, the diabetes drug known as the “slimming pill ”, already in dire straits.
In response, Lilly said that the “unprecedented surge in demand ” for Mounjaro and its similar drug Zepbound has led to a shortage in the market, which the company is struggling to cope with.
Lilly is ramping up investments to boost production at Mounjaro and Zepbound in the second half of 2024.
The company said it expects intermittent supply disruptions in the near term due to unprecedented demand.
How to cure the drug shortage
The last major “drug shortage ” in U.S. history occurred in 2014, and it has only been alleviated in the years since.
Since 2021, the drug shortage situation seems to be increasing, and scholars in the field of medical health and economics in the United States believe that the reason for most drug shortages in the United States is the fragmentation of the drug supply chain.
The White House this month proposed spending between $3.26 billion and $5.11 billion over the next decade to help address the nation ’ s drug shortage.
The bill requires approval and funding from the U.S. Congress.
U.S. researchers and policymakers believe that a complete solution to the “drug shortage ” may require changes to the business model of the U.S. pharmaceutical industry, including measures to increase the price of generic drugs to attract more drug manufacturers.
Policymakers recommend giving the FDA more power to access more information about drug shortages and impending shortages.
Currently, the FDA relies primarily on phone calls to manufacturers asking if they can increase their supply to understand the situation.
The American Society of Health System Pharmacists said it is working with the federal government to advise the government on measures to address the drug shortage, including that Congress should require manufacturers to be more transparent on any supply chain issues and encourage more diversity in supply chains.
According to Abramowitz, “The federal government still has a lot of work to do to fundamentally address drug shortages, and the American Society of Health System Pharmacists will continue to engage regularly with policymakers to guide them in drafting and passing new legislation to address drug shortages and continue to advocate vigorously for proven solutions on behalf of our members. ”

A COVID-19 shutdown at a GE Healthcare plant caused a global iohexol shortage, forcing hospitals to postpone cancer treatments, delay or modify CT exams, and consider expanding U.S. manufacturing capacity.

Title:

Content: Newswise — OAK BROOK, Ill. (May 19, 2022) – Recent disruptions in a pharmaceutical supply chain have impacted the global availability of GE Healthcare Omnipaque™ iohexol iodinated contrast media (ICM) for radiologic examinations. A new Special Report published in the journal Radiology provides consensus recommendations for dealing with the shortage of ICM in the near term and discusses long-term issues and potential solutions to supply chain problems.

“We are facing issues similar to those we faced in the early days of the COVID-19 pandemic, caused by a limited supply of an important pharmaceutical, critical to our ability to care for our patients,” said Thomas M. Grist, M.D., chair of the Department of Radiology at the University of Wisconsin School of Medicine and Public Health in Madison and lead author of the Radiology Special Report. “One important difference, however, is that our hospitals and health systems are more adept at establishing incident command centers to implement rapid responses to the challenges we face and communicating those changes to our patients and referring physicians.”

Iohexol is a common agent used in a multitude of CT and X-ray exams. The iohexol shortage has created a national challenge to radiology’s collective ability to provide health care to patients needing these exams and will have short- and potentially long-term impact on quality medical care.

Although four companies supply ICM to the U.S., other manufacturers are unable to rapidly scale up ICM production to meet the demand created by the reduction in iohexol.

The shortage traces its origins to the recent COVID-19-related shutdown of a manufacturing facility in Shanghai, China. In an April 19 letter to consumers, GE Healthcare announced it would be limiting orders of iohexol. The facility has since reopened with production output currently at 50% and expected to increase. GE Healthcare has also expanded production capacity at its manufacturing site in Cork, Ireland.

“It is too easy for us to take for granted the readily available supply of something that is so important to our patients and our radiologic practices until it’s gone,” Dr. Grist said. “We need to commit to changing the supply chain so that a single event in a faraway country does not put us in this predicament again. We owe it to our patients who trust us with their lives and well-being every day of the year.”

The shortage has already had an effect on patient care. Across the U.S., hospitals dependent on iohexol are postponing treatment-monitoring imaging for cancer patients, as they attempt to preserve the contrast material for the most urgent cases.

The Special Report offers strategies for mitigating the impact of the shortage. Short-term strategies include establishing an incident command center to direct and monitor ICM usage, delaying elective contrast-enhanced CT exams, converting exams to non-contrast when possible, reducing contrast dose, and substituting other types of exams, such as MRI, ultrasound or non-contrast PET-CT.

Strategies for the coming months include contrast repackaging, multi-use, and multi-access tactics, negotiation with payers on billing and reimbursement, and consistent communication with ordering providers to ensure compliance.

Long-term strategies include advocating for legislation to facilitate contrast manufacturing plants in the U.S., improving institutional inventory of contrast supplies, and supporting the vendors to expand manufacturing.

“RSNA and its journals are committed to providing critical guidance to help our members navigate challenging times,” said RSNA President, Bruce G. Haffty, M.D. “This Radiology Special Report provides helpful strategies for managing the iodinated contrast shortage and offers practical recommendations for mitigating the impact of future shortages of this type on the radiology community and our patients.”

The authors hope that the radiology and hospital communities will take this lesson as a wake-up call to adapt the radiology supply chain to prevent similar emergencies in the future.

“We need to endeavor to ensure that companies with significant market share have diverse production locations and capacity,” Dr. Grist said. “We should also look at the ancillary components for ICM administration and make certain we have adequate supplies in stock. Any and all supplies we use may be the next subject of shortages over the next few months or years.”

See also: Iodinated Contrast Shortage Challenges Radiologists.

###

Short-, Mid-, and Long-Term Strategies to Manage the Shortage of Iohexol.” Collaborating with Dr. Grist were Cheri L. Canon, M.D., Elliot K. Fishman, M.D., Maureen P. Kohi, M.D., and Mahmud Mossa-Basha, M.D.

Radiology is edited by David A. Bluemke, M.D., Ph.D., University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, and owned and published by the Radiological Society of North America, Inc. (RSNA) (https://pubs.rsna.org/journal/radiology)

RSNA is an association of radiologists, radiation oncologists, medical physicists and related scientists promoting excellence in patient care and health care delivery through education, research and technologic innovation. The Society is based in Oak Brook, Illinois. (RSNA.org)

For patient-friendly information on contrast materials, visit RadiologyInfo.org.

SEE ORIGINAL STUDY

The EU proposed a solidarity mechanism, joint procurement, stockpiles, a Critical Medicines Alliance, and enabled shelf-life extensions and domestic production to smooth distribution.

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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France logged 4,925 drug shortages in 2023, affecting 44% of the population in 2024; health groups sought transparency as EU reforms aimed to boost responsiveness with safety stocks and streamlined timelines.

Title:

Content: French health groups put forward proposals to limit the damage of worsening drug shortages

Medicines such as cough syrup, lozenges and ointment are seen on a table in an apartment in Berlin, Tuesday, December 20, 2022. Copyright Stephanie Pilick/dpa via AP
Copyright Stephanie Pilick/dpa via AP
By Lauren Chadwick
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Pharmaceutical companies’ lack of transparency leads to rising drug prices and less control over public resources, the group of health organisations say.

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A group of French organisations have called for more transparency from pharmaceutical companies as drug shortages increase.

In a joint report, 14 civil society organisations outlined their recommendations to solve a “situation that has only worsened” since 2018.

The French medicines regulator signalled 4,925 drug shortages in 2023, compared to 3,761 in 2022 and 2,160 in 2021.

A 2024 survey from France Assos Santé, which represents patients, found that 44 per cent of people in France said they had faced a drug shortage this year.

One of the pharmacy unions in France has even planned a strike at the end of the month over drug shortages and what they say is worsening access to care.

Each health organisation contributed an article with recommendations for dealing with the drug shortages.

The League Against Cancer urged complete transparency on drug shortages and potential substitutions for health professionals.

They also called for monitoring of medicine stocks and their location in the country to guarantee equal access.

The organisation found in a survey published in February that 78 per cent of health professionals in oncology had been faced with a drug shortage.

Drug shortages or delays have led to anxiety among cancer patients, lost time, and worsening symptoms, the organisation said.

France Assos Santé, meanwhile, wrote that an urgent response should not be to support “the industrial sector which bears serious responsibilities” for abandoning the production of less profitable drugs, relocating drug production, and keeping insufficient medicine stocks.

They would like any cost increases justified by production costs or the risk of withdrawing a drug from the market due to it being unprofitable. They called for cost evaluations to be made public.

Their concerns also range from the use of public money to bring drug production to Europe to new government plans to prevent shortages.

Some changes at the EU level criticised

Last year, the European Commission announced several measures to reform the pharmaceutical industry and address critical drug shortages.

The European Parliament went on to adopt a position on pharmaceutical reform last month, that included “incentives for innovation” and an effort to limit overuse of antibiotics.

The non-profit organisation Prescrire, which focuses on information about medicine, wrote in a chapter they contributed to the report that while some of the European Commission’s measures were welcome, others were concerning.

One of the many measures they rejected included the Commission’s proposal to reduce the number of days of scientific evaluation of drugs from 210 to 180, which they said was necessary time rather than an “administrative obstacle”.

While the NGO welcomed some measures such as government drug shortage prevention plans, it said the Commission should allow EU states to require pharmaceutical companies to have safety stocks of medicine and sanction those that do not respect them.

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French consumer organisation UFC-Que Choisir and the European Consumer Organisation (BEUC) said that they had hoped MEPs would shorten the length of time for “data protection” to allow generic medicines to be marketed more quickly.

Instead, MEPs approved shortening the period to 7.5 years, “which is almost the same duration as the current 8 years [yet] within the framework of the text adopted by Parliament, companies can gain additional months of protection under certain conditions to reach a total of 8.5 years,” UFC-Que Choisir said.

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The war in Ukraine disrupted pharmacy supplies and complicated cross-border shipments, affecting treatment continuity for patients.

Title:

Content: There are problems, but there will be no shortage: pharmacies explained why there are not always the necessary drugs on sale
The ongoing war, unjustified growth in demand and problems with production lead to a short-term absence of certain drugs in pharmacies.
Martial law imposes additional difficulties on the import of medicines, but Ukrainian pharmaceutical companies have practically solved this problem: they produce 61% of medicines from the National List of Medicines.
About this Delo.ua told pharmacists and manufacturers.
In the pharmacy holding ANC explain that they fix several main reasons why some positions may disappear in the network:
1.
Due to the martial law in the country, the supply of goods from abroad is irregular, because not every carrier is ready to transport the goods to a country where hostilities continue;
2.
In such cases, insurance companies do not cover the transportation of goods due to high risks;
3.
Completion of the registration period of the goods;
4.
The company producing the goods decided to leave the Ukrainian market.
While data on foreign trade are available only in the context of 4 digits of the code UKTVED, more detailed statistics are not published in the conditions of martial law.
But these data also indicate a reduction in the supply of drugs from abroad, which was confirmed in Goslikluzhba.
Pharmacists note that they do not affect suppliers or the supply of goods.
If the drug is absent from the main distributors, the pharmacist can only recommend analogues to the client in the positions that he can offer.
“At the same time, unfortunately, there is no alternative for unique imported drugs.
Probably, if the state provided manufacturers and suppliers with additional guarantees, this could change the situation, ” adds Maria Semenova.
At the same time, as noted in the pharmaceutical company "Darnitsa", with temporary problems with the presence of a foreign medicine, Ukrainian manufacturers can offer generics of similar quality.
Pharmacists agree that manufacturers are successfully closing the gap in the market, but note that they do not produce innovative new drugs of the latest generations and original drugs, as well as drugs necessary for the treatment of rare diseases.
At the same time, the reduction of imports of medicines to Ukraine has a positive effect - it contributes to the growth of the production of domestic medicines.
Because, as noted in "Darnitsa", an increase in the production of domestic drugs leads to GDP growth, the number of jobs and tax revenues to the country's budget.

Russia’s pharmacies faced shortages from failed tenders, procurement delays, and reliance on foreign substances, exacerbated by sanctions and price hikes.

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Health Crisis 2024 expert From pharmacies continue to disappear important drugs.
Why Russia has not yet established their production
Important medicines continue to disappear from pharmacies.
Why Russia has not yet established their production
Roszdravnadzor claims that everything is enough with the stock.
However, this is not visible on the shelves.
Recently, important drugs are regularly missing from pharmacies throughout Russia.
In the first days of April, diabetics could not find ultrafast insulin Fiasp on the shelves.
Following him, the vital drug from oncology "Uromitexan" disappeared.
At the same time, Roszdravnadzor assures: medicines continue to be produced in the country, and they are even with a reserve.
But why are they not in pharmacies and what will happen to the assortment next?
These and other questions about the "Schrödinger drugs" MSK1.RU asked experts in the field of pharmaceuticals.
And this is how they explained the disappearance of the drugs.
Failed to collect the needs
Most drugs for the treatment of cancer, diabetes, HIV and similar serious diseases are supplied to pharmacies through government channels.
To do this, the authorities must collect requests from the regions, form a tender purchase and deliver the received medicines to pharmacies.
However, as the expert of the pharmaceutical market Nikola Milevchich told MSK1.RU, in these processes there are often failures.
— If there was no such tender, this procedure does not start.
There have been no tender purchases for a long time, the remains of medicines have been bought out in pharmacies, and we see a shortage of these products in the retail chain, ” he explained.
According to the expert, delays in procurement occur for various reasons.
For example, if the Ministry of Health has not yet collected applications from the regions or they themselves did not have time to provide the necessary information.
In addition, drugs may not be purchased, because pharmacies have stocks from last year, and they are not necessary.
— The first quarter is always quite difficult, because the money is allocated for a year, and while the state will distribute the money, issue a tender, deliver goods — it ’ s a few months, — explained Milevčić in an interview with MSK1.RU. — It happens that the supplies of the fourth quarter are loaded in the first quarter in the account of the previous year.
Moreover, priority areas, products, the list of vital drugs are constantly changing.
They want to raise the price, but they can ’ t.
There are other reasons for the lack of medicines in pharmacies.
One of them is sanctions.
In 2022, many foreign pharmaceutical companies made statements about changes in their work in Russia.
Some have stopped investing, others have suspended clinical research.
Most of them stopped providing medicines.
In some places you can still find the remains of foreign drugs, but they are not endless.
And the production of analogues takes time.
And although the government has already formed a list of priority molecules that are now being actively introduced for production at Russian plants, most of the components for the production of equivalent replacements need to be brought from abroad.
Currently, Russia is 90% dependent on the supply of pharmaceutical substances from abroad.
And logistics in the last couple of years has noticeably become more complicated and, as a result, has risen in price.
Further simple mathematics.
In order not only to recapture costs, but also to earn, it is desirable for manufacturers to raise prices for their product.
But they can't do that.
Especially when it comes to those drugs that are included in the list of vital and essential (VED).
By law, they must be sold at a fixed registered price.
And there's practically no Navara here.
- Manufacturers often refuse to register and leave the market due to the fact that they do not get the opportunity to re-register their price, - said MSK1.RU Nikola Milevchich.
There are no analogues
At the same time, according to one of the sources of MSK1.RU in the field of pharmaceuticals, analogues of some drugs in Russia have not yet learned to produce.
And the original has to be transported from abroad, but through neutral intermediary countries.
- Some production facilities, of course, are localized, however, there is a wide range of drugs included in the list of VED, the production of which, for one reason or another, is impossible within the country, - said our source. - Because of this, we have to reorient the logistics chains and add neutral countries that did not exist before.
If earlier drugs could be directly brought to Russia from Switzerland or France, now neutral countries are added to this chain, which include, for example, India, China and some Asian states.
And this directly affects both the delivery time and the cost of drugs on the market.
Due to the increase in transport costs, those drugs that disappear from pharmacies are returned at much higher prices.
One of the brightest examples is the drug "Zepatir" for the treatment of hepatitis C. Until 2022, it cost up to 10 thousand rubles, and now it is 90 thousand, "the source told MSK1.RU.
Zepatir is manufactured by the American pharmaceutical company MSD.
She notified the Russian Ministry of Health of the termination of deliveries in 2023.
According to pharmacists, there are no analogues of the drug.
By this principle, drugs for ASIT therapy (allergen-specific immunotherapy, when the allergy is injected with small doses of the allergen that is the cause of the disease) - "Staloral birch", "Staloral mites", "Oralair meadow herbs" have soared in price.
Prices for it go up to 9 thousand rubles.
What About Essential Medicines
If the drug included in the list of VED disappears from pharmacies, the Ministry of Health should solve the problem of its shortage as soon as possible.
It can offer an analogue or contact the manufacturer and demand an acceleration of deliveries.
— There are funds, social groups that, with the support and consent of the Ministry of Health, make urgent purchases and supplies for certain patients with a threat to life due to the fact that there is no necessary drug.
This is a kind of force majeure, a way out of the situation, where, of course, the state must find a solution for these patients, ” said Milevcic.
When the Ministry of Health finds an analogue of the missing drug, it adds it to the list of VED.
However, even an analogue must undergo certain research and registration, so it will not work in a short time.
How long it will take, our experts have not been able to clarify.
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In Egypt, patients suffered and died amid shortages of critical drugs like insulin and chemotherapy, worsened by raw-material and pricing issues.

Title:

Content: Crowding citizens in front of the ambulance pharmacy reveals the extent of suffering …
6.
The suffering of poor patients is due to the lack of medicines.
Where the pharmaceutical market has been suffering for several consecutive months from a severe shortage in many varieties.. Which prompted citizens to crowd in front of the ambulance pharmacy in long queues to buy those shortcomings after they disappeared from all pharmacies..
Hustle...
Chaos...
Hundreds of men and women crowded in long queues that extend for several hours.. This is the scene in front of the ambulance pharmacy in the center of the country. People with chronic diseases of sugar, pressure, heart, nerves and colon became their only hope to find essential drugs for them in the pharmacy.. The absence of these drugs does not only expose them to more pain but may expose them to death.. They can not do without them..
The drug shortage crisis.
It is not a new crisis, but it has been repeated many times during the previous term of Minister “Khaled Abdel Ghaffar ”.. Instead of trying to solve the crisis, the government is going against the trend, where the Deputy Prime Minister and Minister of Health Dr.“ Khaled Abdel Ghaffar ” in statements after the government statement to parliament to the need to increase the prices of medicine in Egypt because it is the cheapest in the world and sold abroad by 50 times. According to the data of the Medbelle global platform for health care and funded by the European Fund for Regional Development in 2021, Egypt is ranked ninth in the list of cheapest countries in the world in the sale of medicine, and did not come in the first place as mentioned by the minister
Despite the repeated statements of the Prime Minister and the Minister of Health to resolve the crisis and provide the missing medicines, and despite the government ’ s repeated talk about the localization of the pharmaceutical industry in Egypt, the reality is quite the opposite.
There are a number of terrible complaints about the lack of medicine in public hospitals and pharmacies, including a collective complaint from the patients of the university hospitals in Assiut Governorate of the lack of availability of drugs and the absence of dye injections, which puts their lives at risk. Although the patients filed a complaint to the governor two weeks ago, but to no avail. The long queue of two or three hours to win a box of insulin Maxtard despite the increase in the price from 60 pounds to 93 pounds confirms the extent of suffering experienced by patients. Also, the disappearance of Indoxan injections used in chemotherapy sessions threatens oncology patients, where thousands of patients in oncology institutes and hospitals suffer from delayed chemotherapy sessions for lack and disappearance of Indoxan injection. The right to medicine, but the crisis still exists.
There is also a shortage of many drugs, including blood thinners and clots solvents, drugs for the treatment of cancerous tumors, multiple sclerosis drugs, drugs for the treatment of liver diseases, drugs for stomach ulcers and blood pressure, drugs for sinuses, heart and thyroid diseases, dozens of types of analgesics, antibiotics and vitamins, as well as anesthetics used in anesthesia and solutions in public hospitals. Subsidized children, which was exploited by the mafia of the black market to raise prices to double the original price of milk can up to 500 pounds..
All types of treatments for epilepsy, depression, obsessive-compulsive disorder, phobias and hyperactivity disease are still unavailable due to the lack of import of raw materials.
Health Insurance Patients
The crisis is not limited to hospitals and pharmacies only, but the branches of health insurance suffer from a large shortage of medicine and also medical supplies, which led to the closure of the operating rooms in the branches of insurance in the province of Beni Suef..
In the health insurance clinics in Cairo and Giza, many of those who frequent these clinics complained that they come from 7 am to reserve their roles in order to dispense their medicines and end up sitting in the pharmacy waiting for the pharmacist who dispenses them some of them, and the rest of their medicines are separated in new prescriptions to be dispensed from the insurance pharmacies, if any. Blood thinners and thrombotic solvents, some pressure medications, multiple sclerosis medications, stomach ulcer and thyroid medications, sugar, antibiotics, vitamins, Parkinson ’ s medications, and hyperactivity protocol.
Many cases complained of the lack of their medicines, which they have been dispensing for years.. And they were dispensed periodically every two months for a year after the approval of the Drug Committee to dispense those medicines, including a special medicine liquidity imported medicines, and patients with diabetes and blood diseases were their complaint that any imported medicine and its price expensive requires the highest approval of a committee in the Council of Ministers..
Although patients have been dispensing the same medication for several years, this complaint is frequent from universal health insurance patients.
Detention of raw materials
Dr. Ali Auf, head of the pharmaceutical division of the Federation of Chambers of Commerce, said that the reason for the worsening of the shortage of medicines is the detention of raw materials in ports, pointing out that there are about 1000 items that are not available.
Exchange rate
Mahmoud Fouad, Executive Director of the Right to Medicine Association, said that the aggravation of the crisis is due to the companies stockpiling medicines in anticipation of higher prices, explaining that the crisis began about two years ago due to the shortage of raw materials as a result of the high exchange rate and the inability of companies to provide dollar materials to import raw materials.
Fouad stressed that there are more than 1000 drugs whose prices rose during the past year by rates ranging from 25% to 60%, pointing out that the increase reached during the current days to 60% for the local and 80% for the importer.
Fouad described the statements of the Minister of Health about the price of Egyptian medicine as being 50 times lower than abroad as shocking, pointing out that there was a successive movement of prices from the Drug Pricing Committee of the Egyptian Drug Authority starting in 2023, which resulted in the movement of about 1,000 varieties.
He explained that Egypt suffered during the last two years from the phenomenon of medicine shortage due to the shortage of imported raw materials as a result of the economic crisis and the fluctuation of the exchange rate … and the crisis affected items considered life-saving.
Fouad stressed that drug sales in Egypt reached about $3 billion a year in 2023 without the sales of the armed forces and the interior and tenders of the Ministry of Health, which means that Egypt is considered the largest market in the region.
Unfair pricing system
He explained that Egypt had been subject to the pricing of medicines for 10 years according to the decision of the Minister of Health under the system of "lower pricing for neighboring countries" and then the pricing was according to the decision 413 of 1991, which is "calculating the cost and profit margin for companies and distribution and then pharmacies" according to the compulsory pricing that began in 1988.
He explained that the pricing is according to the cheapest price in the reference countries identified by the World Health Organization (WHO) in 36 countries to guide their prices and the minister to take them or not, pointing out that these countries are the major industrial countries and have comprehensive health insurance laws, which Egypt lacks.
Fouad added that this system in pricing is unfair as medicine has become subject to market mechanisms, supply and demand and suspicions of monopoly, the price is controlled by the policy of supply and demand, which makes medicine a commodity sold to those who can, especially since there are more than millions of Egyptian people not participating in the health insurance system, which only 63% of citizens participate.
Fouad pointed out that Egypt has about 17 officially registered medicines, 90% of which are manufactured, 176 companies that own factories, 7 business sector companies, 22 branches of foreign companies and 1,200 commercial companies that do not own a factory.
He stressed that the crisis of medicine shortage and successive rises will make the Egyptian citizen groaning and unable to bear it.
Fouad warned of the danger of the expected increases in drug prices during the coming period.

Egyptian authorities sought to ensure availability through a hotline, imports, and inspections.

Title:

Content: President of the Drug Authority reviews the efforts of the State to follow up the availability of medicines and control the
Wednesday ، 24 July 2024 09: 53 PM
Chairman of the Pharmaceutical Authority and Prime Minister
Written by Hind Mokhtar - Photo by Sulaiman Al-Atefi
Leave a comment and read the comments of the readers.
Dr. Ali Al-Ghamrawi, President of the Egyptian Pharmaceutical Authority, held a press conference today at the headquarters of the Council of Ministers in New Alamein City, in the presence of Dr. Mostafa Madbouly, Prime Minister, during which he reviewed the efforts exerted by the State to face all challenges facing the Egyptian pharmaceutical market, as well as the stability of the availability of medicines.
During his speech, the Chairman of the Authority stressed that the availability of medicine has been gradually affected during the past months, which was linked to the challenges in obtaining foreign currency necessary to import raw materials, despite the fact that the Egyptian state has placed the pharmaceutical industry in the priorities of management, but it has gradually affected the volume of strategic stocks of a number of raw materials with high consumption rates. Market availability rates, as well as some recently observed practices related to the purchase and storage of supplied products in excess of actual need, creating an increasing and unreal demand for a number of pharmaceuticals in circulation.
He pointed out that all previous challenges to the availability of these products have been met by measures taken by the state and urgent decisions on all parties in the pharmaceutical market, which began to reconsider the pricing of some important medicines after liberalizing the exchange rate, taking into account the social aspect of citizens to raise production rates to full capacity and ensure a fair price in accordance with the government ’ s commitment to the economic dimension of the pharmaceutical industry.
He added that these measures included directing importers to increase the import quantities of a number of vital medicines, reducing the import period by converting various shipping methods to urgent air freight and direct communication with suppliers of effective and ineffective pharmaceutical raw materials to increase the import rates of all raw materials in production at local factories. Her crown.
On the scope of distribution operations, Dr. Ali Al-Ghamrawi, President of the Egyptian Drug Authority, said that the Authority has carefully followed up all distributors and major stores to review the distribution operations to pharmacies, ensure the continuous supply of items that are monitored for availability, and follow a distribution methodology based on horizontal distribution of medicines to ensure that the medicine reaches all pharmacies in all governorates. Distribution in drug stores and distribution companies through a monitoring system developed by the Authority to follow up the pumping of drugs in pharmacies.
He pointed out that the Authority continues to launch intensive inspection campaigns on all pharmacies to follow up the availability of various items and ensure that no drug item is sold, in addition to taking immediate action in case of violations, pointing out that the number of inspection visits amounted to about 55 thousand inspection visits during the first half of 2024. Supply of pharmaceutical products from distributors to pharmacies.
He pointed out that the increasing demand on some brand names for a number of traded items contributed to creating an unreal need, pointing out that the Authority pays great attention to the follow-up of the provision of all types of drugs and alternative preparations in different therapeutic groups.
He added that the Authority provides many direct communication platforms that allow the patient and pharmacist to inquire about the availability of medicines, such as the hotline 15301, the "violation" service, and the "availability" service, where the Authority receives all inquiries and complaints about the availability of any drug 24 hours a day. He explained that the Authority monitored the lack of availability of a number of these items in 19 governorates after receiving a number of reports from more than one pharmacy stating that some distributors refrained from supplying medicines to them, so the expanded inspection campaigns were able to control the market in these governorates for the monitored items.
At the end of the press conference, Dr. Ali Al-Ghamrawi stressed that the Egyptian state has developed a plan to support industry partners and other government institutions concerned with the pharmaceutical issue by taking immediate measures to provide a future strategic reserve of all medicines and important preparations with high consumption rates up to six months to meet any future challenges.