On October 2, the U.S. Food and Drug Administration (FDA) Drug shortage database indicated that the shortage of tirzepatide injection (Zepbound, Mounjaro/Lilly) is now “resolved.” The agency wrote: Instructions for formulators Lilly said the company is able to meet “current and projected national demand” and that formulators are limited in manufacturing the product.
Nevertheless, patients and prescribers may still experience “intermittent local supply disruptions as the product moves through the supply chain,” the FDA noted.
Alliance of Compounding Pharmacies (APC) responded quicklyalerted its members and the public that the shortage was resolving and said compounders “must immediately cease preparing and dispensing compounded copies” of the two drugs.
However, APC CEO Scott Brunner added that it often takes a long time for an FDA-approved version of the drug to be widely available to wholesalers, hospitals and clinics. Even after Lilly announced increased availability of the drug, including new vial formats for lower doses, “most pharmacies are lucky to get two to three boxes of Zepbound a day from wholesalers.” Because of the waiting list of patients, the number is in the hundreds.”
“We have already heard from APC members this morning that they are unable to fulfill patient orders,” he said.
He added: “I think a lot of patients who are taking combination tirzepatide are going to be worse off by this. They’ll be cut off and they won’t be able to get their prescriptions anymore. They’ll have to go to the hospital and be seen.” There will be,” he argued. Although it takes time for health care providers to receive new prescriptions, a significant number of patients may be currently taking complex GLP-1. [glucagon-like peptide 1] Eventually, they will switch to the FDA-approved version — if they can afford it, of course — and the tirzepatide shot will once again be in short supply. ”
Commenting on addressing the shortage, endocrinologist Beverly Chan, MD, DABOM, assistant professor of clinical medicine at Weill Cornell Medical College in New York City, said: Medscape Medical News“While the shortage has not yet been eliminated, we hope this will eliminate at least one barrier to patient access.”
“I don’t think there will be any confusion,” she said. “For better or worse, both patients and clinicians are now adept at transitioning treatments, because each time insurance discontinues coverage, shortages recur, or coupons expire, Because we’ve been forced to move toward treatment, which is clearly not ideal, but where the patient is motivated, the clinician is not.
Medscape Medical News previously reported on how endocrinologists and obesity medicine experts responded to the shortage, given its impact and concerns about compounding pharmacies that may or may not be well-founded.
Chan declared himself an advisor to Novo Nordisk.
Marilyn Larkin, MA, is an award-winning medical writer and editor whose work has appeared in numerous publications, including Medscape Medical News and its sister publications MDedge, The Lancet (where she was a contributing editor), and Reuters Health. Featured in publications.
