|
Vets Ignore FDA's CIS Guidelines
This appeal reveals that
many veterinarians refuse to provide CSI (Client
Information Sheets) to animal owners. Known in
human medicine as "prescription inserts" or side effects warnings. You must ask
"Why?"
Draft
16A-5721
Professional Conduct
October 18, 2005
To: Pennsylvania State Board of
Veterinary Medicine
Board Administrator - Bob Kline
2601 North Third Street
P.O. Box 2649
Harrisburg, PA 17105-2649
Dear Mr. Kline:
I greatly appreciate the opportunity to
submit the following comments on the above
referenced proposed rulemaking and am
especially grateful for the Board’s
extension of the comment deadline.
First, I want to laud the Board for seeking
to improve the quality of veterinary medical
practice in Pennsylvania by spelling out in
detail key issues with respect to practice
standards. By doing so, the Board is making
it very clear to the veterinary profession
what standards of practice are expected of
them and as such should serve to improve the
quality of veterinary medical practice in
Pennsylvania.
However, there is one area of direct
personal concern to me that I wish to bring
to the Board’s attention because I feel it
is vital that this issue be addressed in a
written standard by the Board, namely, a
mandatory rule that veterinarians be
required to provide owners with copies of
the “Client Information Sheet” (CIS) for all
drugs which they dispense for
administration in the home.
To do otherwise is to say to owners of
companion animals in Pennsylvania that their
veterinarians and the Pennsylvania State
Board of Veterinary Medicine consider
themselves to be more expert in these
matters than the veterinarians of the FDA’s
Center for Veterinary Medicine, the nation’s
experts in drug safety.
BACKGROUND
As the nation’s experts in drug safety, the
Food and Drug Administration is charged with
approving all drugs and setting rules for
their use. The FDA has determined that a
select group of drugs pose serious health
risks and are only safe when they are
accompanied by carefully developed and
approved information that is given to
patients and caregivers.
On the human side of the FDA, this
information is provided in a document known
as the Medication Guide. Regulations
governing these Guides are spelled out in
detail in 21 CFR 208 promulgated under the
authority of Public Law 104-180.
The FDA’s Center for Veterinary Medicine has
similarly determined that under authority of
21 CFR 201.105 (c)(1) ["adequate directions
for use"], that they have an obligation to
require Client Information Sheets for
certain veterinary drug products that pose
serious health risks to companion animals.
There is one major difference between these
two documents: While pharmacists are almost
religious in ensuring that patients and
caregivers receive Medication Guides,
veterinarians, with utter disregard to the
welfare of their patients, almost never
provide this life-saving information to
their clients.
Pharmacists consider it their ethical,
professional and statutory duty to ensure
that patients and caregivers receive
Medication Guides, while veterinarians
appear to be uniformly opposed to providing
clients with information that the nation’s
experts in veterinary drug safety have
determined is critical to the safe use of a
select group of drugs.
I have myself lost my beloved companion,
Jetta, under circumstances in which I
believe she would be alive today had I been
give the Client Information Sheet for a drug
she took. Since her loss, I have involved
myself in this issue and see this happening
day after day. Nevertheless, I make my case
on the basis of studies of this issue by the
FDA, not my personal experiences.
Below I am listing for your reference
studies and articles on the problem of
owners not being provided Client Information
Sheets written by FDA staff over the past
few years.
JAVMA News
April 15, 2004
Minimizing the risk factors
associated with veterinary NSAIDs
Drug risk information is communicated to
veterinary practitioners and to the public
through the product labeling. Labeling
includes the package insert, the vial or
bottle label, the carton label, the client
information sheet, and some types of
promotional materials. Drugs that
come with client information sheets are
intended to be dispensed to clients with the
client information sheet accompanying the
prescription. [emphasis added]
In many cases of adverse drug experiences,
pet owners report they never
received the client information sheet from
their veterinarian. [emphasis
added] In the Jan. 15, 2004, JAVMA, staff at
the CVM published an article titled
"Emerging issues regarding informed
consent." That article reported evidence
that pet owners are increasingly concerned
about risks and benefits of commonly
prescribed veterinary drugs. The article
stated that most of the CVM concerning
adverse drug experiences now come from
consumers rather than veterinarians.
http://www.fda.gov/cvm/index/fdavet/2004/Mar-Apr04.pdf
JAVMA News
Jan 15, 2004
Emerging issues regarding informed
consent
The staff at the Food and Drug
Administration's Center for Veterinary
Medicine has conducted a two-year review of
consumer messages to our adverse drug
experience hotline. The review indicates
increasing concern by consumers about risk
and benefit of commonly prescribed, approved
animal drugs.
Frequent comments from pet owners who
contact the CVM hotline include these:
-
They did not receive a
client information sheet when one was
available for a drug that was prescribed
for their pet. [emphasis
added]
-
The medication they received from
their veterinarian was not dispensed in
the CVM-approved container but was
broken into aliquots that were taken
home without the client
information sheet or approved label.
[emphasis added]
-
The veterinarian did not conduct or
recommend blood testing before and after
prescribing the drug, even though
baseline testing and/or periodic
monitoring was recommended on the label.
Common examples include heartworm
products and nonsteroidal,
anti-inflammatory drugs.
-
After reading client
information sheets and labels on the
Internet about a drug prescribed for
their pet, they discovered that their
pet may have fallen into a category of
animal for which a precaution or
contraindication existed.
[emphasis added]
Given these findings, we have the following
reminders for practitioners:
|
