Veterinarians find themselves in an awkward position when they can’t obtain a drug a patient needs. But that’s the reality today for some practitioners, who have noticed an apparent uptick in the number of drugs reported as unavailable.
Pet owners have noticed, too, and have posted complaints at VeterinaryPractice News.com, particularly in regard to Oncept, a canine melanoma vaccine made by Merial Ltd. of Duluth, Ga.
“I had several canine cancer patients scheduled to Oncept receive Oncept and I couldn’t provide their therapy because I didn’t have access to the drug,” says Zachary Wright, DVM, Dipl. ACVIM (oncology), of VCA Veterinary Care Animal Hospital and Referral Center in Albuquerque, N.M.
“I was told a shipment of the drug was held up by the Food and Drug Administration. I can’t say if this delay affected my patients’ therapy end results. It was very uncomfortable telling clients I couldn’t help their pet right in the middle of treatment.”
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For an up-to-date list of recalled drugs and products with delayed manufacturing, check the U.S. Food and Drug Administration website.
• Here were some drugs on back order at press time:
Most drug manufacturers contacted by Veterinary Practice News declined to comment either on why shortages of their products have occurred or their protocol when it happens. They referred questions to Ron Phillips, vice president of public and legislative affairs at the Animal Health Institute, which represents about 13 companies with an interest in animal health.
“Companies have animal health at the core of their being and usually make recommendations to veterinarians as to what actions they should take when a shortage happens,” Phillips says. “These companies have a lot at stake, too, and while shortages happen for a variety of reasons, manufacturers always want to have their products be safe, effective and available to veterinarians.”
Phillips notes that animal health product sales totaled
$6.7 billion in 2008 and U.S. companies spent about 10 percent of sales revenue on research and development. Manufacturers invested some $670 million back into their products for 2008, he said.
A representative of Merial, which makes Oncept, said the company’s goal is to keep all products in full supply by projecting the need, maintaining efficient manufacturing processes and keeping adequate supplies of all products in inventory.
“There are a variety of reasons shortages might occur,” says Natasha J. Mahanes, a Merial spokeswoman. “Some reasons include interruptions in manufacturing processes, regulatory issues and supply chain disruptions. Merial handles communication of shortages on a case-by-case basis, depending on the product in question, the market need for the product and expected shortage timeframe.
“In general, customers are notified promptly and offered guidance on interim treatment options if necessary and appropriate. When experiencing a product shortfall, Merial works with the appropriate parties to return to full supply as soon as possible.”
Some veterinarians say drug companies keep them in the loop as to why the drug isn’t available and when to expect the product back in stock. Others say manufacturers’ responses are completely void.
“We get vague answers as to why drugs aren’t available,” Dr. Wright says. “We call the company and get timelines that come and go without any communication, and still no drug availability. For someone who relies on these drugs in everyday practice, not knowing how or when you will have access to them again is very scary. We go through doxorubicin like water. We’re a cancer specialty practice, so, yes I am very frustrated.”
No law specifies a manufacturer’s responsibility to notify customers about an expected drug shortage. This means no explanation is required and consumers and veterinarians are at the manufacturers’ mercy.
The agency monitors only FDA-approved drugs and in the case of veterinary medicine, treats drugs deemed medically necessary as a priority. The agency’s policy is to attempt to prevent or alleviate shortages of medically necessary veterinary products, or MNVPs.
The FDA asks to be notified of shortages, including an assessment of the causes and potential solutions. But manufacturers are slow to reach out to the FDA.
“We work with manufacturers to say what they need to do to fix manufacturing issues,” says Martine Hartogensis, DVM, deputy director of the FDA’s Office of Surveillance and Compliance. “The more proactive the company is in involving the FDA and preparedness to prevent shortages, the less likely that company will experience a shortage. However, that rarely happens and I can only guess as to why they don’t contact us sooner.”
Dr. Hartogensis speculates that companies fear the FDA instead of viewing the agency as a means to an end of a manufacturing issue.
“More recently, drug shortages have almost always been caused by a manufacturing issue,” Hartogensis says.
“This could be because of a failed FDA inspection, or using only one supplier for the drug’s main ingredient. If this supplier has a problem, the manufacturer can’t produce the drug. It’s a mystery as to why companies don’t have backup suppliers.”
Hartogensis says the FDA in some cases allows manufacturers to produce drugs under “enforcement discretion.” This means manufacturers can do something they wouldn’t normally be allowed to do. When this action is taken, veterinarians using this non-FDA standard drug must inform clients and obtain a signed informed consent. This occurs most frequently in critical-needs programs.
“The FDA mandates that users must be aware there is an issue with the drug and decide if they still want to use it,” Hartogensis says.
Hartogensis says drug manufacturing issues seem to be more common now than in days past, but says other factors play a role in shortages: discontinued manufacture of a drug as a business decision, new products replacing old ones, limited manufacturing capability and market concentration.
“The quantities of a given product manufactured and maintained in inventory are based on careful analyses of market needs and conditions,” Merial’s Mahanes says. “The analyses take into account historical use patterns, market growth, seasonality, promotional program timing, emerging competition, product expiry and other factors.
“The goal is to make certain that we manufacture and stock sufficient product to meet expected demand. Additionally, extra inventory beyond that required to meet projected need is held to take care of unexpected demand or supply interruptions.”
Sometimes products are manufactured in another country, which adds transportation delays, Hartogensis says.
“Most delays are simply because companies don’t have a Plan B when something goes wrong,” Hartogensis says.
What Practitioners Think
A September 2010 survey of more than 1,800 health care practitioners by the non-profit Institute for Safe Medication Practices showed a lack of information about a shortage’s duration, with 85 percent of respondents saying this was frequently a problem during the past year.
About one in three respondents said their facility experienced an error that could have led to patient harm during the past year because of a drug shortage.
Other difficulties cited were:
• Little or no information available about the duration of a drug shortage
• Lack of advanced warning from manufacturers and suggested alternatives
• Little or no information about the cause of the drug shortage
• Substantial resources spent investigating the shortage and developing a plan of action
• Difficulty obtaining a suitable alternative product or lack of one
• Financial loss
For the full report, click here.
Veterinarians say few generics are being produced even when the product is eligible. More generic options would reduce stress on veterinarians when their first choice isn’t available. Compounding pharmacies can fill the void, but laws and guidelines prevent them from manufacturing every out-of-stock drug.
“If we get an order from a veterinarian, we make sure the product isn’t commercially available,” says Paul Franck, RPH, FAVP, owner and CEO of Franck’s Pharmacy, a compounding facility in Ocala, Fla. “We obtain the bulk chemical through legal means and we stop compounding the product when it’s back on the market.”
FDA regulations limit what compounders can replicate, sometimes contending that a product is a new drug, Franck says. Compounders are disputing this argument in court.
“We can make a drug that is on back order as long as it isn’t patented,” Franck says. “We can service veterinary practices nationally and have a drug mailed out the same day if necessary.”
Tommy Ho, PharmD, of Allstar Pharmacy, a fledgling Houston compounder, says the company has received requests from veterinarians to compound drugs that are on back order, and he is often able to help.
“We get our ingredients from the Professional Compounding Centers of America if we don’t already have it in stock,” Ho says. “We’re able to manufacturer capsules, sterile injections, suppositories, suspensions and more.”
Hartogensis notes that manufacturers experience a financial loss when they can’t produce drugs, but animal drug production often is a much smaller part of a company whose focus is on providing drugs for human use.
“On the other hand, when shortages are discussed, rumors start to fly,” Hartogensis says. “Be leery about where you find your information.”