Aug
9
2006

While veterinary professionals believe they tell clients about risks associated with non-steroidal anti-inflammatory drugs (NSAIDs), clients tell the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA) a different story.

In the last three years the number of NSAID-related complaints to the CVMs Adverse Drug Experience telephone hotline has steadily increased, which may reflect more drug use or failure to effectively communicate risks and identify warning signs of adverse reactions, according to industry professionals. The most common consumer complaint to the FDA is that veterinarians did not mention risks associated with NSAIDs. Such miscommunication – either perceived or real – undermines client trust and jeopardizes pet health, say veterinary professionals who are trying to rectify the communication gap.

AAHA’s efforts to educate veterinary professionals about NSAIDs
include
NEWStat stories and a Trends special section on NSAIDs that will run in the November/December issue. Future educational initiatives will be featured on the website at www.aahanet.org so please visit regularly for updates.

 

In conversations with pet owners, Pfizer representative Kristina Wahlstrom, VMD, MS, heard clients say they had not been told about the risks associated with NSAIDS. “When side effects occurred they felt blind-sighted, and lost trust in their veterinarian,” she said. Despite that data, Wahlstrom said it is difficult to convince some doctors that they can do more to educate clients.

“They don’t see the consequences of their styles of communication or what they choose to communicate. When asked they say that they communicate well but they don’t follow-up with the owners to gauge comprehension,” Wahlstrom said.

As one of at least five NSAID manufacturers, Pfizer launched a communication effort known as the FRANK initiative early this year to improve client communication. It will entail a redesign of client information sheets as well as a series of educational sessions that focus on learning styles and ways to interact more effectively with clients.

“It doesn’t matter what we say to clients, it only matters what clients hear,” said Robin Downing, DVM, president of the International Veterinary Academy for Pain Management (IVAPM).

Judging from the growing number of complaints received by the CVM, many clients do not understand NSAID risks and are not watching for and reacting quickly to adverse reactions like vomiting, diarrhea, and inappetance if they occur. Veterinary professionals are also guilty of overlooking those early warning signs, which are common ailments in many pets, said FDA professionals.

“We are so close and so familiar with some of the [early signs] that we don’t really stop” to consider what a pet on NSAIDs could be trying to tell us, said Michelle Sharkey, DVM, veterinary medical officer with the FDA Office of New Drug Evaluation.

When adverse reactions are noted, the FDA encourages veterinarians to report their findings to the drug manufacturer since companies are required by law to submit adverse drug experience (ADE) reports to FDA. In addition, the FDA welcomes veterinarians to report ADEs to the agency online.

“We encourage veterinarians to give out client information sheets, discuss risks versus benefits, reevaluate patients [quickly] and change doses or drugs if appropriate.” The bottom line, say FDA professionals, is “We want to remind veterinarians to empower clients to ask questions.”

Toward that end, Sharkey wrote an article titled “What Veterinarians Should Tell Clients about Pain Control and Their Pets” for the FDA Veterinarian. The article, published July 28, 2006, has detailed information about NSAIDs, when they should be prescribed, potential side effects, and the message: “Veterinarians are in the best position to inform their clients about these side effects, so the clients can take better care of their pets. And, pet owners expect veterinarians to explain all potential risks of medications.”


How do you talk about NSAID risks?

In practice, however, professionals admit that communication about NSAID risk versus benefit is as inconsistent as the protocol for reporting problems. Some doctors use software programs to issue warnings when NSAIDs are prescribed; some verbally warn clients about the possibility of side effects, and some use client information sheets. One veterinary professional said she tries to scare clients with stories about pets that have developed perforated ulcers while on NSAIDs, but does not use NSAID client information sheets for fear that “the client will decide not to use the drug. What the doctor decides is the best course of action,” she added.

Reporting adverse reactions is even spottier, according to veterinary professionals. Some report adverse reactions to manufacturers, others send information to the FDA, and a few said they were unaware of any reporting structure at their clinics.

When in doubt about which resources to use, FDA representatives urge veterinary professionals to utilize every avenue to communicate risk versus benefit information. They believe that better client education will result in increased visits and better medicine overall.

This month the IVAPM plans to publish all known NSAID client information sheets on its website for client and professional use, Downing said. She also referred to Lifelearn, Inc., a company that produces customizable client handouts for identification of pain, and said that pharmaceutical companies provide safety data on every product distributed. AAHA members can also access the pain management protocol for guidance. Standard PM8 through PM9 provide a written pain management protocol with specific information about side effects, complications and concurrent drug interactions.

“We want to take advantage of every venue in our outreach to veterinarians to make their lives easier,” said Bernadette Dunham, DVM, PhD, deputy director of the Office of New Animal Drug Evaluation. Referring to the collaboration between AAHA, FDA, and drug manufacturers she added, “Everybody is on the same page.”

Dunham and other FDA representatives emphasized the importance of doctors pairing the right medication to the right pet, and said that signs of a mismatch include vomiting, diarrhea, and inappetance. Those signs should be immediately flagged by owners and veterinary professionals to avoid serious, long-term side effects, she said.

Downing concurred. She runs extensive tests before prescribing NSAIDs to ensure that patients do not have underlying organ issues and can safely take the drugs. A pain consultant and owner of Windsor Veterinary Clinic, Downing said she rarely sees such test results in patient files from other clinics.
“I routinely see patients placed on these medications without any metabolic assessments; without any idea of renal or liver status, bone marrow and thyroid [function,]” she added. Depending on the pet, Downing assesses CBC and renal panels, hepatic function, blood sugar, albumin and – for seniors – a urinalysis. Although it does not happen frequently, Downing has disqualified patients for NSAID use because of the test results. “It doesn’t happen often but it’s often enough to realize that this [testing] is an essential part of the process,” she explained.

If a patient is an appropriate candidate, Downing prescribes an NSAID and schedules a check-up visit one week later to weigh the pet and assess overall response to the drug.


Educational Focus

Although NSAIDs have gotten significant media coverage recently, these drugs share the news spotlight with questions about vaccine frequency, vaccine-induced sarcomas, non-economic damages and the increasing emphasis on legal issues in veterinary medicine. Therefore, it is no surprise that the CVM has requested AAHA’s help in ensuring that veterinarians educate clients about all risks associated with pet care, said professionals.

“We are not focusing exclusively on benefit/risk information,” said Bob Fauteux, public relations director for Pfizer Animal Health. “To be successful, [we need to] shift conversations from one-sided – with doctors telling clients what they think they should hear – to a collaborative approach,” he explained.

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