For any medical professional looking to avoid waste by continuing to use Akorn pharmaceuticals recalled due to company bankruptcy, Lauren Forsythe has a quick piece of advice:
While there are no known issues with the products on Akorn’s human and veterinary drug recall lists, they are not expected to be used because the business is closed and “will not be able to support or guarantee that the products will meet all specifications anticipated through the shelf life indicated on the product label”, according to the art Announcement by Akorn dated May 2.
FDA spokeswoman Siobhan DeLancey indicated the recall is a precaution. “To date, the FDA is not aware of adverse events directly related to product quality issues associated with Akorn-manufactured drugs since January 2022,” she told VIN News Service.
Trouble is, any future problems could go unnoticed, said Forsythe, a veterinary pharmacist and faculty member at the University of Illinois at Urbana-Champaign College of Veterinary Medicine. “Concern about usage [the recalled drugs] it’s the fact that if something goes wrong, there’s no way to find out from anyone else,” he said.
After filing for Chapter 7 bankruptcy on Feb. 23 and now closed, Akorn is not seeking the return of its products, nor is it offering refunds, presumably because financial hardship is what drove it into bankruptcy.
According to Forsythe, most healthcare professionals have means to safely dispose of expired or otherwise unusable medications. For drugs classified as controlled substances, they must file a US Drug Enforcement Agency Form 41 and make the products “non-recoverable,” he said.
Drugs that are not controlled substances can be disposed of in any way practices normally handle such products. “We don’t want to put them in water or trash,” advised Forsythe, who is also a clinical pharmacology consultant at the Veterinary Information Network, an online community for the profession and parent of VIN News.
The number of specific veterinary drugs on Akorn’s recall list it is small: nine. His list of drugs labeled for human use is much larger: 75. All are generic.
Forsythe doesn’t expect the loss of veterinary drugs to be a major problem for physicians with ample substitute products available, but the loss of some of the human products used in veterinary medicine could cause a short-term snag, she said.
Notably, injectable methadone, used in the clinic to manage pain, especially in cats, is now in a backlog, he said, noting that Akorn “had 51 percent of the market share.”
Forsythe said doctors may choose hydromorphone instead, but it’s not ideal, as it can cause vomiting.
And although methadone is made by other companies, because it is a Schedule II controlled substance, manufacturers’ production quotas will have to be adjusted by the DEA and manufacturers will have to increase their production capacity, both of which take time, he said.
Another product that may be temporarily short is sufentanil, a powerful opioid pain reliever, as well as some ophthalmic medications, Forsythe said.
In the grand scheme of things, Akorn’s recall, however extensive, isn’t expected to have a profound effect on veterinary practice, Forsythe said.
That was the experience of Dr. Alison Gussack, a home veterinarian in Tennessee. Her practice used some Akorn eye drops and an injectable sedative. The impact of their loss is “very inconvenient” but “a small financial loss for us,” she said, amounting to less than $500, including the cost of replacements.
“Hospitals with larger inventories will lose quite a bit more,” Gussack noted.
The main problem is that “rsubstitute products quickly become unavailable or in very low quantities when something unexpected like this happens,” he said, adding that available substitutes are sometimes, but not always, more expensive.
If replacement products are backordered, Forsythe recommends placing orders anyway because suppliers “generally fill backorders first.”
The situation “will resolve itself eventually,” he said. “It will take some time for the supply to move.”
#Due #failure #Akorn #drugs #discarded