Akorn HQ ... now defunct
Screenshot from video on Akorn.com
Akorn, a pharmaceutical company based in Illinois, filed for bankruptcy in February and has ceased all U.S. operations.
To any medical professional wanting to avoid waste by continuing to use Akorn pharmaceutical products that are recalled due to the company's bankruptcy, Lauren Forsythe has a quick piece of advice:
Although there are no known problems with products on Akorn's human and veterinary drug recall lists, they should not be used because the business is closed and "will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product," according to an Akorn announcement dated May 2.
FDA spokesperson Siobhan DeLancey indicated that the recall is a precaution. "To date, the FDA is not aware of any adverse events that are directly related to product quality issues associated with drugs manufactured by Akorn since January 2022," she told the VIN News Service.
The trouble is that any future problems could go undetected, said Forsythe, a veterinary pharmacist and faculty member at the University of Illinois at Urbana-Champaign College of Veterinary Medicine. "The concern with using [the recalled drugs] is the fact that if something were to go wrong, there's no way to find out from anybody else," she said.
Having filed for Chapter 7 bankruptcy on Feb. 23 and now closed, Akorn is not calling for a return of their products, nor is it offering refunds, presumably because financial difficulty is what led it to go belly up.
According to Forsythe, most health care practitioners have means of safely disposing expired or otherwise unusable medications. For drugs that are classified as controlled substances, they must fill out a U.S. Drug Enforcement Agency Form 41 and render the products "non-retrievable," she said.
Drugs that are not controlled substances can be discarded in whatever way practices normally handle such products. "We don't want to put them in water or trash," advised Forsythe, who also is a clinical pharmacology consultant at the Veterinary Information Network, an online community for the profession and parent of VIN News.
The number of veterinary-specific drugs on Akorn's recall list is small: nine. Its list of drugs labeled for human use is much more extensive: 75. All are generic.
Forsythe doesn't anticipate that losing the veterinary drugs will pose much of a problem for clinicians, there being ample substitute products available, but the loss of some of the human products that are used in veterinary medicine could cause a short-term hitch, she said.
Specifically, injectable methadone, used in-clinic to manage pain, especially in cats, is on backorder now, she said, noting that Akorn "had 51% of the market share."
Forsythe said clinicians may choose hydromorphone instead, but it's not ideal, as it can cause vomiting.
And although methadone is made by other companies, because it's a Schedule II controlled substance, manufacturer production quotas will have to be adjusted by the DEA, and manufacturers will need to increase their production capacity, both of which take time, she said.
Another product that may be temporarily short is sufentanil, a potent opioid painkiller, as well as some ophthalmic drugs, Forsythe said.
In the grand scheme of things, the Akorn recall, extensive as it is, shouldn't have a profound effect on veterinary practice, Forsythe said.
That's been the experience of Dr. Alison Gussack, a house call veterinarian in Tennessee. Her practice used some Akorn eye drops and an injectable sedative. The impact of losing them is "very inconvenient" but "a small financial loss for us," she said, amounting to less than $500, including the cost of replacements.
"Those hospitals with larger inventory will be losing quite a bit more," Gussack noted.
The main issue is that "replacement products quickly become unavailable or in very low quantities when something unexpected like this happens," she said, adding that available substitutes are sometimes, but not always, more costly.
If replacement products are on backorder, Forsythe advises placing orders anyway because vendors "generally fulfill backorders first."
The situation "will correct itself eventually," she said. "It's just going to take time for the supply to shift."