Last fall, Jody Dushay, MD, an endocrinologist at Beth Israel Deaconess Medical Center in Boston, got a message from her patient with type 2 diabetes. His pharmacy had one semaglutide (Ozempic) pen left, and they could only hold it for five minutes.
Dushay would have to call in a refill right away, or the patient would lose a week's worth of medicine, as Ozempic is a once-weekly injection.
Demand for GLP-1 agonists like semaglutide has risen as their reputation for helping patients drop pounds has taken off. Just like patients with obesity, patients who were prescribed these drugs for type 2 diabetes are struggling to access their medications.
Patients are crossing state lines and ordering from abroad to keep up with their regimens. Doctors are jumping through hoops for their patients. Pharmacies are weathering unpredictable supply.
"It's like gold," Dushay told ľֱ. "This is the reality. It's crazy."
It's not uncommon for her patients to run out of their medication, Dushay said. They may have to check multiple pharmacies, or else be stuck waiting. She also tells patients to look up Canadian pharmacies that can mail their meds.
Gitanjali Srivastava, MD, an internist and director of the obesity medicine program at Vanderbilt University Medical Center in Nashville, Tennessee, said her patients have also resorted to using Canadian pharmacies, and they sometimes pay for their medications in cash.
"Our clinic has been inundated with messages and phone calls," Srivastava told ľֱ.
Ethan Melillo, PharmD, an ambulatory care diabetes pharmacist who works with primary care practices in Rhode Island, said his patients are feeling a significant impact, and sometimes calling different pharmacies or substituting one medication for another isn't enough.
For example, when a pharmacy runs out of 3-mg doses of dulaglutide (Trulicity) but has 1.5-mg doses in stock, insurers might not authorize a patient to double up on the lower-dose injections.
"So they're pretty much allowing the patient just to go without," he said, adding that he's had patients call him after being off a GLP-1 agonist for weeks and "their sugars are in the four-hundreds."
"I really want this to end," Melillo said. "But it's like a couple of times a week, we'll have a patient who says, 'I need help.'"
Robert Gabbay, MD, PhD, the chief science and medical officer of the American Diabetes Association (ADA), said in an email to ľֱ that the ADA "feels strongly that people who have a medical condition should have access to treatment. We're very much concerned about anything that limits access to effective treatments for diabetes and for those at risk of being diagnosed with diabetes."
All three of the most popular GLP-1 agonists are listed as "currently in shortage" on the : semaglutide, dulaglutide, and tirzepatide (Mounjaro), the latter of which is a dual GLP-1/GIP agonist that's shown even more dramatic effects on weight loss and is expected to win an approval for that indication later this year.
Since , Novo Nordisk has struggled to produce enough semaglutide to keep up with demand for its obesity indication. Problems with the manufacturing of the syringes used in their pens prompted mass shortages, and the company at the end of 2022 that all doses were again available.
Novo Nordisk wrote in an email to ľֱ, that Ozempic .25-mg and .5-mg pens were still having supply disruptions, "due to the combination of incredible demand coupled with overall global supply constraints. While product continues to be manufactured and shipped, patients in some areas of the country will experience delays with these doses. Anyone concerned with continuity of treatment should contact their healthcare provider."
Eli Lilly wrote in an emailed statement to ľֱ that "strong demand for Trulicity and Mounjaro, amplified by global competitor incretin shortages, is resulting in potential short-term delayed delivery and restocking of supply at some pharmacies and wholesalers."
The company said it is continuing "to invest and add manufacturing and supply capacity around the world. With the addition of our manufacturing facility in North Carolina, coupled with additional actions and expansions at other sites, we expect to double Lilly's incretin capacity by the end of 2023."
As for the risks to patients, going off of a GLP-1 agonist for type 2 diabetes can certainly lead to increases in blood sugar and "this turns out over time to a greater risk for complications of diabetes," Gabbay said.
Srivastava said generally, patients who stop taking a GLP-1 agonist "can pick up from where they left off, because the medicine does last for a while in their system, so I think that's important for patients to understand," she said, noting that it can last for "several weeks."
"Whereas prompt discontinuation of insulin therapy can be disastrous for a patient, [this] is not necessarily the case with this specific class of medications," she noted.
Experts say that though it may be tempting to blame shortages on , people who don't meet clinical guidelines getting the drugs off-label and out-of pocket at , or even on patients with obesity and their providers for turning to diabetes medications, the reality is more complex than any one of those factors. (Click here for a sidebar exploring the reasons behind the shortages.)
"I think it started out with the semaglutide because of the interchangeability and because of the efficacy of these medications," Srivastava said, "and it has trickled to pretty much all of the GLP-1 agonists."
Disclosures
Stanford disclosed consulting and other financial relationships with Novo Nordisk, Currax, Eli Lilly, Boehringer Ingelheim, and Rhythm.
Srivastava has reported consulting and other financial relationships with Novo Nordisk, Eli Lilly, and Rhythm.