Drug shortages: The new norm for veterinary medicine? - DVM
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Drug shortages: The new norm for veterinary medicine?


Reasons for shortages

Why shortages occur is a difficult question to answer, but one that has many theories. Sometimes, not even pharma watchdogs can get answers.

In regard to shortages of fentanyl injections, ASHP says the shortage began Oct. 5. Some formulations of the analgesic have been discontinued, but West-Ward, which acquired Baxter's fentanyl injection products in May 2011 could not provide a reason for the shortage. Hospira reports its shortage is due to increased demand, according to ASHP. In the case of norepinephrine injections, ASHP cites a shortage date of Oct. 6, with reasons for the shortage ranging from manufacturer delays (Bedford), discontinuation (Teva) and increased demand (Hospira). FDA allowed a temporary importation from Canada to mitigate the shortage, ASHP says.

For MNVPs, the answers are similar. FDA says animal-drug shortages can result from unavailable raw materials, unavailable packing materials, marketing decisions by manufacturers and FDA enforcement issues. MNVPs are defined by FDA as drugs used to treat or prevent a serious animal disease or condition; drugs needed to assure the availability of safe food products originating from animals; or drugs that are available from only one source or for which no adequate substitutes are available.

Arnel B. Peralta, DVM, drug-shortage coordinator at FDA's Center for Veterinary Medicine, says the agency monitors possible drug shortages through interactions with veterinarians, pet owners and professional organizations, and through direct contact with drug manufacturers. Once a shortage is verified, FDA works with drug manufacturers in the United States and, when necessary, abroad, to find ways to resolve the shortages. But FDA can't require any company to make a product, Peralta adds.

Recent examples of FDA interventions in shortages of MNVPs include Vetsulin and Immiticide.

FDA announced in May 2010 that it would allow Intervet/Schering-Plough Animal Health to offer a limited supply of Vetsulin through a critical-need program. Only dogs and cats whose diabetes could not be managed on other insulin products would qualify for the program, FDA says. The shortage resulted from FDA's concern over the stability of the drug in November 2009. The product was ultimately discontinued in early 2011.

In the case of Immiticide, FDA announced it would allow Merial to import limited amounts of the European version of the drug, which is used to treat heartworm in dogs. The solution is temporary while Merial works out technical issues in the plant where Immiticide is manufactured, FDA says. However, the amount of imported Immiticide will not be enough to satisfy the domestic need for the drug, FDA cautions, and there is no word on when the shortage will be resolved.

The shortage of Levimasol HCI is attributed to a manufacturing site delay, and epinephrine shortages are due to discontinued distribution, according to FDA.

Many times, drug makers find themselves in shortage of raw materials because their suppliers are mostly, if not all, overseas, Jordan says. FDA must approve those suppliers, and sometimes there are issues there, she says.

"I think there are several things causing (drug shortages)," adds Hohenhaus. "There are fewer companies making generic drugs. If there are fewer companies maybe making as not a wide variety of drugs and their plant goes offline, there's a problem."

"And I think that there are very few veterinary drugs. We really depend on off-label. As more human drugs are shortaged, it affects us," she adds.

Many of the shortages in human-medicine products used by veterinarians are with older injectable drugs, Jordan explains. In those cases, manufacturers will often divert their supply lines to newer, more profitable drugs.

Profit plays a role in another theory as to why shortages occur. Sometimes, drugs fall off patent and become generic, and are no longer profitable for drug companies to produce, says Sabino.

"It's not cost-effective for them to produce them, and there's a lot of government regulations they don't want to put up with," Sabino says.

In those cases, opportunities to obtain the drugs may sometimes arise in alternate markets that drive the price up. People are willing to pay anything for the medications at that point. Hohenhaus says drugs will often go up drastically in price following a shortage.

"Sometimes, I think to myself that this might be one of the reasons we are having these shortages, so they can get the right pricing to make it cost-effective to produce," Sabino says.


Source: DVM360 MAGAZINE,
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