Thank you Dr. Bob, for granting permission to cross post.

Jean Townsend - Johns Island, SC
(Always for George - Always for the Rimadyl Dogs)

In a message dated 8/11/2006 10:47:38 A.M. Eastern Daylight Time,
drbob@... writes:

A Veterinary Twist on the “He Said/She Said” Scenario: What Doctors Say
Versus What Clients Hear and Understand
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 CVM's
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_ (http://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_ (http://www.cvmbs.colostate.edu/ivapm/) (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.

W_hen adverse reactions are noted_
(http://www.dogsadversereactions.com/FDAVeterinarian.html) , 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_
(http://www.fda.gov/cvm/adereporting.htm) .

“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_
(http://www.fda.gov/cvm/FdaVetFirst2006.htm#6058) . 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._ (http://www.lifelearn.com/c3/3000a.html) , 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_ (http://www.aahanet.org/members_only/practice/Standardshomepage.cfm) .
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.





[Non-text portions of this message have been removed]