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, almost never provide this life-saving
information to their clients for their companions.
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. Pet owners
commonly are not warned about potential risks and how to identify
the symptoms so they can react properly and in a timely manner
Below
are listed 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]
"DID YOUR VET GIVE YOU AN
INFORMATION SHEET FOR YOUR PET’S Rx?
It could mean the difference between life and death!"