Finance Network News April 15th (Editor Xiaoxiang) The United States seems to be facing an unprecedented large-scale "drug shortage"...

According to the data from the American Society of Health-System Pharmacists (ASHP) and the Utah Drug Information Service Center, in the first three months of 2024, a total of 323 drugs in the United States were in short supply. This is the highest level tracked by ASHP since 2001, exceeding the 320 drug shortage in 2014.

According to the above statistics, from emergency injection to diabetes drugs, the supply of all drugs is very tight.

Affected drugs include widely used diabetes drugs such as Ozempic and Mounjaro, allergy treatment drug adrenaline, common antibiotics for children such as amoxicillin, chemotherapy drugs, and injectables commonly used in hospital intensive care.

ASHP CEO Paul Abramowitz stated in a statement, "Almost all categories of drugs are facing shortages. Some of the most worrisome shortages involve non-patent sterile injectable drugs, including cancer chemotherapy drugs and emergency drugs stored in hospital ambulances and operating rooms."

Last year, the American Cancer Society issued a warning that chemotherapy drugs had returned to the list of the top five most affected drug shortages, warning that this could have a devastating impact on patients.

Some hospitals and clinics have reported that they have completely run out of some chemotherapy drugs. Doctors have to ration cancer drugs or triage patients.

Abramowitz also stated that attention deficit/hyperactivity disorder (ADHD) medications are continuously in short supply nationwide in the USA, which remains 'a problem for clinicians and patients'.

This includes the prescription drug Adderall for treating ADHD. The shortage of this medication started at the end of 2022, initially due to a delay in shipments from a manufacturer. According to the US Food and Drug Administration, as of early 2024, the current shortage is now being driven by demand.

Due to being labeled as a miracle weight-loss drug, eli lilly and co's diabetes medication Mounjaro is also facing a severe shortage. American patient Stan Brady usually needs to take Mounjaro to avoid complications that may arise from uncontrolled blood sugar levels. However, due to the shortage, his doctor had to switch him to another diabetes medication.

However, Brady mentioned that so far, the new medication does not control blood sugar as effectively as Mounjaro. Brady said, 'I just find it incredible that you can't find this medication, and it seems like no one is taking any action about it.'

Eli Lilly and Co responded that the 'unprecedented surge in demand' for Mounjaro and their similar medication Zepbound has limited their supply. The company also found an interruption in the supply of an older diabetes medication, Trulicity. The company stated, 'We realize that this situation may disrupt people's treatment plans, so we are purposefully and urgently working to address this issue.'

Eli Lilly and Co is investing in production and supply capabilities to increase the output of Mounjaro and Zepbound in the second half of 2024. The company mentioned that due to the unprecedented demand, intermittent supply interruptions are expected in the near future.

According to individuals in the local medical industry in the USA, many of the currently scarce medications are actually generic drugs. Drug shortages mean that some patients have to visit multiple pharmacies to find medications, wait longer for critical treatment, or be forced to accept alternative medications. If generic drugs cannot be found, patients may need to pay more to purchase brand-name drugs. Drug shortages are also increasing the risk of medication errors for patients, as hospitals have to adjust dosages.

Where does the 'drug shortage' in the USA come from?

In fact, in recent years, the shortage of pharmaceuticals in the USA has become an ongoing and increasingly serious issue. While some brand-name drugs (such as Ozempic and Mounjaro) are only in short supply because their manufacturers have not kept up with demand, many scholars in the medical, health, and economic sectors still attribute the majority of drug shortages to the disruption of the pharmaceutical supply chain, making it difficult for generic drug manufacturers to make a profit and sustain their operations.

Many generic drug manufacturers have exited the industry in the past few years or outsourced production to countries with lower labor costs such as India. If a factory halts production, it leads to shortages that persist—there are almost no suppliers to fill the gap, and initiating the production of a certain drug is not easy, especially for sterile injectables commonly used in hospitals, as the production process is very intricate.

In March last year, due to a severe shortage of the anticancer drug cisplatin, the FDA had to seek help from china meheco group's Qilu Pharmaceutical.

Erin Fox, a pharmacist at the University of Utah responsible for collecting data on drug shortages, said, "We haven't seen how many shortage issues have been resolved. For many drugs, there may be only one or two suppliers, so when you lose capacity there, there is no additional redundant production capacity."

Joel Zivot, an anesthesiologist and critical care physician at Emory University Hospital, often has to substitute one drug for another due to drug shortages. He pointed out, "This substitution practice is extremely frustrating. But this situation is happening every day."

Historically, the last sustained drug shortage in the USA peaked in a similar way in 2014, and it was not until several years later that the situation began to improve. Since 2021, shortages have been increasingly severe again. Researchers and policymakers believe that to completely solve this problem, it may be necessary to change the commercial model of the pharmaceutical industry in the USA, including taking measures to raise the prices of generic drugs so that sales can support manufacturers and attract more companies.

Earlier this month, the White House proposed spending $3.26 billion to $5.11 billion over ten years to help address drug shortages. The plan will include linking Medicare payments to hospitals with their ability to purchase drugs from companies that can prove the quality of the drugs long-term, rather than just based on the cheapest price. The proposal requires approval and funding from Congress.

Policymakers also suggest giving the Food and Drug Administration (FDA) more power to access more information about drug shortages and impending shortages—information currently scarce at the agency. Currently, the FDA mainly relies on making phone calls to manufacturers to ask if they can increase supply to understand the situation.

Robert Califf, Director of the Food and Drug Administration, FDA, told the House Oversight Committee last Thursday, "Right now, the information we get from manufacturers is very fragmented. We have spent a lot of time on phone calls in vain."

The American Society of Health-System Pharmacists pointed out that it is collaborating with the federal government to provide recommendations on addressing drug shortages, including urging Congress to require manufacturers to be more transparent on any supply chain issues and encouraging more diversification in the supply chain.

Abramowitz stated, "To fundamentally solve the problem of pharmaceutical shortages, there is still a lot of work to be done at the federal level. The American Society of Health-System Pharmacists will continue to regularly engage with policymakers, guiding them to draft and pass new legislation to address drug shortages, and continue to strongly advocate for effective solutions on behalf of our members."