By Katie Thomas, New York Times. Above photo: George Vander Linde checked for morphine from a dispenser at Norwegian American. CreditAlyssa Schukar for The New York Times
NOTE: I have heard the United States’ healthcare system described as third world. Some of our health outcomes such as infant mortality and life expectancy, particularly in poor black and brown communities, are comparable to developing nation status. Canadian medical residents who do medical rotations in hospitals in the US describe seeing disease progression that they don’t see in Canada. People in the US experience serious disease progression because they can’t afford their medications or treatment or they postpone seeking care out of fear of the cost.
For the past few years, hospitals in the US have started experiencing drug shortages. Imagine having a serious car accident or even a simple fracture or serious wound, going to Emergency Room and not being able to get pain medication because they have run out.
What we are experiencing is the result of a for-profit model. Pharmaceutical corporations are making less of drugs that are not profitable or are not maintaining facilities for drugs that are not profitable. The availability of medications should not depend on whether they are profitable or not. If the drugs are needed by patients, then we need to produce them and make sure that health facilities have them.
We can try to rein in the pharmaceutical corporations through regulations, etc, but as long as they are focused on maximizing profits, we will not fully solve the problem. We need a health system that is focused on health, not profits.
A national single payer healthcare system will have the purchasing power to keep pharmaceutical prices down. And, if pharmaceutical corporations are not producing the drugs we need, we ought to create public entities to produce them. In fact, given that most bench research to produce new drugs is done in public institutions, perhaps all of our pharmaceutical production ought to be nationalized. It’s something to consider. – Margaret Flowers
CHICAGO — George Vander Linde tapped a code into the emergency room’s automated medicine cabinet. A drawer slid open and he flipped the lid, but found nothing inside.
Mr. Vander Linde, a nurse, tried three other compartments that would normally contain vials of morphine or another painkiller, hydromorphone. Empty. Empty. Empty.
The staff was bracing for a busy weekend. Temperatures were forecast for the 90s and summer is a busy time for hospital emergency departments — the time of year when injuries rise from bike accidents, car crashes, broken bottles and gunshots.
At Norwegian American Hospital and other emergency departments around the country, doctors and nurses have been struggling for months without crucial drugs like morphine, which is used to ease the pain of injuries like broken bones, or diltiazem, a heart drug. Norwegian has been out of morphine since March, and the shortages are part of a nagging problem that has intensified this year as a rash of decades-old staples became scarce.
Hospitals small and large have been scrambling to come up with alternatives to these standbys, with doctors and nurses dismayed to find that some patients must suffer through pain, or risk unusual reactions to alternative drugs that aren’t the best option.
“So many substances are short, and we’re dancing every shift,” said Dr. James Augustine, a doctor in Cincinnati who works for US Acute Care Solutions, a company that employs doctors who work in emergency departments for hospitals around the country.
One of the main companies that makes the drugs, Pfizer, has warned that manufacturing problems at some of its plants will lower supplies of many of its products — like morphine — until next year.
For years, drug shortages have created a behind-the-scenes scramble as pharmacists, doctors and nurses cobble together fixes that are often invisible to patients. But doctors around the country say the latest shortages are more directly affecting patient care.
A survey in May of emergency doctors by their professional association, the American College of Emergency Physicians, found that 9 of 10 said they didn’t have access to critical medicines, and nearly 4 in 10 said that patients had been negatively affected.
“The lack of pain medications is a huge issue,” said Dr. Benjamin Savitch, who oversees the emergency room at Norwegian American for US Acute Care Solutions. He said that it can be difficult to explain to patients what is happening. “They are often disappointed and frustrated that the system is not functioning at the level it should,” he said.
Like so much in health care, the roots of the drug shortage are complex and seemingly without a simple fix. The vast majority of the products in question are sterile injectable drugs, hospital workhorses that are cheaply priced even though they can be difficult to make. These low margins have led some companies to stop making the drugs, while others have failed to invest in older facilities, leading to a host of quality problems, recalls and plant shutdowns.
The periodic problems were compounded last fall when Hurricane Maria hit Puerto Rico, a major center of pharmaceutical manufacturing, causing a shortage of small saline bags that are a mainstay in hospitals and worsening a yearslong problem with keeping intravenous fluids in stock.
But even as that crisis subsided, hospitals began grappling with the aftermath of another industry cataclysm — serious manufacturing problems at Pfizer, the nation’s largest maker of generic injectable drugs.
In February of last year, the Food and Drug Administration issued a warning letter to the company for problems at its plant in McPherson, Kan., one of several factories Pfizer took over after it acquired the injectable maker Hospira in 2015. The agency described the plant’s manufacturing process as “out of control” and, among other problems, said Pfizer had not properly investigated complaints about vials that contained particles later identified as bits of cardboard. If injected, the agency said the contaminated vials could pose a “significant risk” to patients.
In September, the agency sent Pfizer another warning letter, that time for problems at its plant in a suburb of St. Louis, where the EpiPen is made.
Pfizer names hundreds of products on its list of back-ordered items as it works to fix its plants — the status of many of the drugs is described simply as “depleted,” with an “estimated recovery” date of 2019. The problems have led to shortfalls of other products, including some that Pfizer makes for other companies. In May, the F.D.A. placed the EpiPen on its shortage list, as well as a competing product, Adrenaclick, which is also made by Pfizer. EpiPen is sold by Mylan, while Adrenaclick is sold by Impax Laboratories.
As Pfizer’s supplies have run short, competitors have struggled to keep up with demand, depleting their own stock. The shortage of opioids like morphine has been aggravated by federal quotas that restrict the amount of narcotics any one company can manufacture; this spring, Pfizer relinquished part of its federal quota, which was then reallocated to other manufacturers.
Some of the shortages have become severe enough that the F.D.A. has allowed Pfizer to sell products that normally would have been recalled: In May, Pfizer released morphine and other drugs in cracked syringes, with instructions to health care providers to filter the drugs before injecting them.
Philip J. Trapskin, the program director of Medication Use Strategy and Innovation at UW Health, the University of Wisconsin-Madison’s health system, said such actions pose a risk to patients and said he had instructed his staff to find other suppliers. Otherwise, he said, with about 2,500 nurses in his health care system who might need to use the syringes, “We’re kind of setting them up to fail if we give them something that is cracked and compromised.”
In an interview, Pfizer executives said that while the company regretted the effect the shortages were having on patients, it was investing significant resources in getting the plants up to par after taking them over from Hospira. The company plans to spend $800 million by the end of this year, and has pledged to invest at least $1.3 billion over the next five years. “We are completely aware of the essential nature of our portfolio,” said Navin Katyal, the general manager for the Pfizer Injectables unit in the United States. “The patient is truly our North Star. It’s driving our urgency to recover.”
Mr. Katyal also said that while many supplies won’t return to normal until next year, Pfizer is continuing its manufacturing — albeit at a slower pace — while the plants are being fixed and some of the most critical shortages are expected to be eased by the end of the year.
The current state of drug shortages doesn’t look that bad by the numbers. According to a recent report by the F.D.A., the agency said it had tracked just 39 new product shortages in 2017, compared with a peak of 251 in 2011. And while the F.D.A. described 2017 as a “challenging year,” it also said it had successfully prevented shortages of 145 products by taking actions such as allowing imports of certain products.
But Erin Fox, who tracks drug shortages at the University of Utah, said the figures don’t reflect the intensity of the gaps in supplies. “We’ve had all of these shortages before at different times, but what’s harder about it right now is that it’s all at once,” she said.
Dr. Scott Gottlieb, the F.D.A. commissioner, acknowledged in an interview that while the agency has made progress, it has not solved the underlying problem, where manufacturers earn a slim margin on products that are difficult to produce. “We are still in the position of trying to put a Band-Aid on a market that fundamentally hasn’t changed,” he said.
Dr. Gottlieb said he planned to act shortly on a recent request by members of Congress to look more broadly at the issue. One action, he said, could involve imposing more requirements on manufacturers, while at the same time working with programs like Medicare to increase reimbursement for certain drugs, as when they are used in outpatient clinics.
“Today it’s one drug, tomorrow is going to be another drug,” Dr. Gottlieb said. “We’ve got to think of something more holistic and comprehensive.”
On a recent weekday at Norwegian American, the emergency room had been relatively quiet. But two patients in the intensive care unit were suffering because the emergency room staff did not have the right drugs to give them.
One man, Edwin Alsina, 72, had arrived the night before complaining of a racing heart. The staff normally would have administered diltiazem, also known as Cardizem, that is used to steady an abnormal heart rate. But diltiazem was out of stock, and when two other drugs — adenosine and metoprolol — didn’t work, Mr. Alsina was admitted overnight. By Thursday, he was receiving a steady drip of another drug, esmolol, but his heart rate was still 140 beats per minute.
Another man, Barbaro Gonzalez, 62, had shown up at the hospital earlier in the day with chest pains. Mr. Gonzalez said he has frequently visited the hospital to treat his pain and morphine usually does the trick. But this time, doctors had to give him another opioid, fentanyl, which Mr. Gonzalez said didn’t work as well. He seemed resigned to his fate. With a nurse translating his Spanish, he said, “If they don’t have the medication, you’ve got to live with it.”
Drug shortages are often unpredictable and regional in nature. While Dr. Savitch and his staff have struggled with a lack of morphine and diltiazem, Dr. Augustine in Ohio was out of the anti-nausea drug ondansetron. An alternative medication, promethazine, treats nausea but can cause a severe and uncomfortable reaction in some patients, where the face and other muscles spasm involuntarily.
Ondansetron, also known as Zofran, has been a standard nausea treatmentfor so long, Dr. Augustine said, that many younger doctors have never seen the muscle spasms sometimes caused by promethazine, an older drug.
Dr. Augustine said he meets regularly with emergency physicians from overseas, and his foreign colleagues are stumped by his stories of struggles with drug shortages.
“Our compatriots are just wondering, how can this happen in America?” he said.
Katie Thomas covers the business of health care, with a focus on the drug industry. She started at The Times in 2008 as a sports reporter. @katie_thomas