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7 key questions about worsening drug shortages, answered

A Walgreens seen at night
Most drugs in short supply are older generic medicines that are relatively inexpensive to purchase but complex to manufacture — acetaminophen, for example.
(Marcio Jose Sanchez / Associated Press)
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More Americans are queuing up at pharmacies and discovering they can’t get the critical medicines they’ve been prescribed.

It’s not the fault of the pharmacies. Drug shortages reached a peak in late December when almost 300 medicines were in short supply, at times having “devastating consequences” for patients, according to a new U.S. Senate report.

Among the drugs difficult to obtain are Adderall for attention-deficit hyperactivity disorder; albuterol, which can ease asthma attacks; and a myriad of essential cancer medicines, including those for children.

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Even basic over-the-counter medicines — such as children’s cold and flu drugs — were hard to find last fall when influenza-like illnesses peaked earlier than usual.

With COVID-19, flu and RSV cases rising, drugmakers and retailers say soaring demand is leading to empty shelves.

Dec. 9, 2022

What’s causing the shortages? Is anything being done to alleviate them?

Here are answers to some of the most pressing questions about the situation, according to available information.

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Which drugs are especially at risk?

Most drugs in short supply are older generic medicines that are relatively inexpensive to purchase but complex to manufacture: the pain reliever acetaminophen, the antibiotic amoxicillin, and IV saline solution, for example. Injectable drugs such as the sedative propofol are more than twice as likely to be out of supply than oral tablets.

At the same time, some expensive new medications are also hard to find. Demand for diabetes drugs Ozempic and Wegovy soared after doctors began to prescribe them as an aid to losing weight, a use that federal regulators have not approved. Celebrities and internet influencers fueled demand for the diabetes drugs by sharing their weight loss experiences on social media after starting the injections.

TikTok has helped fuel a trend of doctors prescribing the drug off label to people for weight loss, leading to a medication shortage for diabetic patients.

Dec. 23, 2022

In another example of America’s rising use of medications, demand for Adderall, Ritalin and other ADHD drugs has skyrocketed in the last three years after telemedicine websites eased the way to a prescription, leading to shortfalls for those prescriptions as well.

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You can check to see whether your meds are experiencing shortages on the U.S. Food and Drug Administration’s searchable drug database.

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How bad are the shortfalls?

Medication shortages have been a problem for decades but are getting worse. Between 2021 and 2022, the number of new shortages increased by almost 30%, according to the March report by the Senate Committee on Homeland Security and Governmental Affairs.

The shortages are also lasting longer. More than 15 critical drugs, including the antibiotic ceftazidime, have been difficult to obtain for more than a decade.

The shortfalls, in some cases, have caused delays in treatment and led to an increased risk of medical errors as doctors prescribe substitute medications they are not as familiar with, according to the report. Doctors have had to ration lifesaving medicines and use less effective alternatives.

Yoram Unguru, a doctor who treats children with cancer, told the Senate committee, “Pediatric chemotherapy agents work in concert with one another, and if you are missing one drug, we don’t know what the outcome will be.”

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Why is this happening?

Drugmakers lack financial incentives to make older generic medicines, which have far lower profit margins than expensive new drugs that are protected from competition by patents.

To save money, generic drug manufacturers have moved production to China, India and other countries where labor costs are lower and government regulations are less stringent. About 80% of manufacturers producing active pharmaceutical ingredients — the crucial materials that give drugs their intended effect — are located outside the U.S.

This overreliance on foreign sources for the medications taken by Americans, the Senate report said, poses a national security risk.

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Why can’t the FDA prevent or limit the shortages?

The agency does not have the data it needs to predict which medicines may soon be in short supply. FDA officials were unable to tell Senate staffers the percentage of life-sustaining drugs that had fewer than three manufacturers. The regulators explained they had some information on the manufacturing of crucial pharmaceutical ingredients but that the data were unusable because they were “buried in PDFs” that companies had filed with the agency.

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Can’t the manufacturers do more to disclose when key pharmaceutical ingredients are becoming hard to find?

There can be as many as 20 key starting materials in each pharmaceutical, the report said. And even the drugmaker may not know where those raw materials come from or whether their availability could soon be limited, the Assn. for Accessible Medicines, which represents generic drug manufacturers, told Senate staff.

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For patients, that means there is little information available on the many ingredients in their meds or where those materials come from.

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What is the government doing to address the shortages?

The Senate report recommended that the U.S. invest in increasing the nation’s ability to manufacture the most critical drugs often in short supply. It also recommended that drugmakers be required to report spikes in demand for their products. And this week, Republican leaders of the House Energy and Commerce Committee sent the FDA a letter, questioning why the agency lacked data on the shortages and asking for key details behind the shortfalls of certain crucial drugs, including those for cancer.

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What can patients do?

Until the broader problems contributing to the drug shortages are addressed, gathering information is your best strategy. If your local pharmacy does not have your medicine, look further afield to see whether others in different parts of the city or county have it in stock. Pharmacists can be a font of information. Ask them what they know about the shortage, when it might end and their advice on where the drug could be available. If you still can’t find the medicine, ask your doctor if there is an alternative. Make sure to find out how the substitute drug is different in terms of effectiveness and adverse effects.

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