COMMENTS
REGARDING
(Ed's
note: date has been changed to 12/8/05)
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 .
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 provided 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.
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:
·
Drugs that come with client information sheets are
intended to be dispensed in the manufacturer's container,
with the sheets accompanying the prescription. [emphasis
added]
Adverse
drug event reports at the United States Food and Drug Administration
Center for Veterinary Medicine
Victoria
A. Hampshire, Frederick M. Doddy, Lynn O. Post, Teresa L.
Koogler,
Tina M. Burgess, Priscilla O. Batten, Roderick Hudson, Dorothy
R. McAdams,
and Margarita A. Brown
Journal
of the American Veterinary Medical Association, August 15,
2004
(Volume 225, Number 4), pp. 533-536
FDA
VETERINARIAN
MARCH/APRIL 2004
Adverse
Drug Experience Reports Lead to Label Changes, Other Actions
for Safer Animal Drugs
OPPOSITION TO CIS
Through
various members of the state legislature who are supporting
our efforts, we understand that the Board’s opposition
to a written rule on this matter stems from the following
mistaken views of this issue:
1.
The requirement is not feasible because veterinarians repackage
veterinary drugs and do not have access to Client Information
Sheets.
2. Regulation is deemed unnecessary because current standards
of practice require that veterinarians provide safety information.
3. The board believes that Client Information Sheets cannot
be read intelligently by owners.
4. NSAIDs and similar drugs are safe because they have not
been withdrawn from the market by the FDA.
5. This issue should be dealt with in the context of broad
regulatory action on informed consent.
The Board notes that 49 Pa. Code s. 31.21, Principle 8 (related
to drugs) provides for very specific prescribing, packaging
and labeling requirements related to drugs, specifically:
Paragraph
(d) This regulation also provides that the labeling provided
by the veterinarian shall include "any cautionary statement
specified by the veterinarian or required by
law." [emphasis added]
Addressing
the issues raised by the Board:
1. Repackaging
Every veterinary drug manufacturer has told the FDA that
they have in place a system for providing veterinarians
with all the Client Information Sheets they need. If that
is not true, as the Board is asserting, then the solution
is for the FDA to withdraw approval of bulk packaged drugs
and only allow shipment of drugs in unit-of-use containers
with the Client Information Sheet included in the manufacturer’s
packaging.
Owners
across the country are planning a Citizen’s Petition
to the FDA asking that the agency withdraw approval of bulk
packaging of any veterinary drugs which require a CIS on
the basis that veterinarians claim, as the Board is doing
here, that they do not have access to Client Information
Sheets.
2.
Current Standards
It is completely disingenuous to state that current practice
standards require that veterinarians fully inform owners
of potential side effects of drugs. The FDA has studied
this issue and published an article on this in the August
15, 2004 issue of the Journal of the AVMA stating that veterinarians
are NOT providing owners with vital safety information and
this is a major factor in the adverse reactions reported
to the agency. Day after sad day, animals are dying as a
result of the failure of veterinarians to fully inform owners
of potential problems with a select group of drugs.
If
this is in fact already required, then there should be no
objection to specifying that this requirement should be
fulfilled by veterinarians ensuring that every drug which
has a CIS is dispensed with a CIS. It makes no sense to
leave this up to the whim of the individual veterinarian
given that the nation’s experts in veterinary drug
safety understand fully what information is required and
how to present that information in a way that makes it understandable
by owners of companion animals.
3. Owners are not intelligent enough to read a Client
Information Sheet
Quite apart from the incredible hubris of a statement like
this, the Client Information sheets are specifically designed
by the FDA to provide owners with information that is vital
to the safe use of the drug involved and written in a way
that this information is generally intelligible by owners.
The FDA's experts have deemed that certain drugs can only
be used safely if owners are provided with critical information
about their safe use. They go to great lengths to develop
and approve the Client Information Sheets so that they can
be read by ordinary owners in light of the experience of
the Center for Veterinary Medicine in their constant review
of problems with these drugs.
Here are the FDA's own words describing a Client Information
Sheet, in this case for the veterinary NSAID, EtoGesic:
Similar
to Patient Prescribing Information (PPI), which is commonly
distributed with human pharmacy prescriptions, the Client
Information Sheet is written in "consumer-friendly"
language and provides information in easily understood
terms about the benefits and side effects associated with
the use of NSAIDs and EtoGesic. This Client Information
Sheet will supplement the information provided in the
Package Insert. The Client Information Sheet will be printed
on the reverse side of the Package Insert so that it is
easy for pet owners to locate and read.
It should be noted that the Client Information Sheet is
an integral part of the legal product label and removing
a Client Information Sheet causes the drug to be adulterated
and unsafe.
4.
NSAIDs and similar drugs are safe because they have not
been withdrawn from the market by the FDA
The FDA has specifically stated that these drugs are safe
only when owners are being given safety information:
The Center for Veterinary Medicine considers the approved
veterinary nonsteroidal anti-inflammatory drugs (NSAIDS),
including drugs classified as Cox 2 inhibitors, to be safe
and effective when used according to the label and
when dog owners are informed about common
NSAID side effects. [emphasis added]
Since
it is well known that owners are not being given vital safety
information about the drugs being dispensed by their veterinarians,
the FDA should in fact withdraw approval of these drugs.
5. Need for broader consideration
Having specifically said that Client Information Sheets
should not be provided to owners because they are not intelligent
enough to read them, the board says that if they were to
deal with this issue, it should be in the broader context
of regulation of informed consent.
To date, the FDA has received reports indicating that as
many as 3,500 dogs may have died because of the side effects
of NSAIDs alone. These reports generally represent less
than 1% of actual events which means that as many as 350,000
dogs may have already died as a result of these drugs.
The
solution to this problem is to simply make it clear that
the Board expects veterinarians to provide owners with Client
Information Sheets if the drug they are dispensing for home
administration requires that this information be provided.
If the Board chooses to do more, that is great. But the
key issues in improving the safety of these drugs is ensuring
that owners are given vital information that the FDA says
is required for these drugs to be used safely.
SUMMARY
The
issue is very simple:
The FDA has determined that the safe use of certain drugs
requires that owners be given vital safety information in
a form that the FDA approves that makes this information
accessible to owners. Veterinarians must be required to
provide this FDA-mandated, manufacturer-provided information
to owners.
Signed:
Demitry
Herman of Allentown, PA
Denise
Dost of Philadelphia, PA