Adverse Drug Experience Reports Lead to Label Changes, Other Actions for
Safer Animal Drugs
http://www.fda.gov/cvm/index/fdavet/2004/Mar-Apr04.pdf
Emerging Issues Regarding Informed Consent
http://www.avma.org/onlnews/javma/jan04/040115f.asp
AVMA Home | AVMA Journals Home | JAVMA online | Current JAVMA
NewsJanuary 15, 2004 Emerging issues regarding informed consent
Consumers calling hotline with concerns
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.
The CVM established the hotline, (888) FDA-VETS, in 1996 to receive
calls about adverse experiences to approved animal drugs. We expected
many of these reports to come from practicing veterinarians, but our
review indicates that a majority of the calls in the past few years have
come from consumers, particularly dog owners who find our link on the
Internet.
The CVM considers the drug label the first source of important facts for
veterinarians. The label is the result of considerable scientific
regulatory review before CVM approves the drug. It represents known
safety and efficacy for any one drug. The label also gives veterinarians
important information about whether the drug is suitable for the
individual or subgroup within a species of animal. Additionally,
whenever manufacturers distribute a client information sheet, this means
that either the manufacturer or the CVM wishes to convey more facts
about safety or efficacy in lay terms to pet owners.
The staff at CVM monitors and evaluates adverse drug experience reports
and complaints of inefficacy for approved and unapproved, marketed
products. For approved products, this evaluation of postmarket safety
and efficacy incorporates knowledge gained from the premarket studies as
well as from scrutiny of peer-reviewed studies related to the drug, or
the disease that the drug is intended to cure or prevent.
From the hotline, we have learned that pet owners increasingly rely on
Internet sources for information when their pets have problems. They
have told us that, during their Internet searches, they often find label
information and client information sheets.
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.
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.
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.
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.
Product precautions, contraindications, safety information, and warnings
should help identify animal patients that are not good candidates for
the medication.
Labels change—if you have a large inventory of a product with a
long shelf life, you may want to contact the manufacturer or CVM to
obtain the most recent label. A long shelf life makes it likely that
some of the product won't be dispensed in the near future. Often, this
information is also posted on pharmaceutical companies' official Web
sites.
If you have comments or questions about this issue, contact Dr. Victoria
Hampshire at (301) 827-0158, or
VHampshi@CVM.FDA.GOV.
—Dr. Victoria Hampshire, Adverse Drug Events Coordinator, Office
of Surveillance and Compliance, FDA Center for Veterinary Medicine
Return to top
AVMA Journals | JAVMA News | Discussion Groups | Veterinary Career
Center
Professional Resources | Member Center | Care for Animals | AVMA Home
American Veterinary Medical Association
Copyright © 2004
AVMA Home | AVMA Journals Home | JAVMA online | Current JAVMA
NewsJanuary 15, 2004 Emerging issues regarding informed consent
Consumers calling hotline with concerns
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.
The CVM established the hotline, (888) FDA-VETS, in 1996 to receive
calls about adverse experiences to approved animal drugs. We expected
many of these reports to come from practicing veterinarians, but our
review indicates that a majority of the calls in the past few years have
come from consumers, particularly dog owners who find our link on the
Internet.
The CVM considers the drug label the first source of important facts for
veterinarians. The label is the result of considerable scientific
regulatory review before CVM approves the drug. It represents known
safety and efficacy for any one drug. The label also gives veterinarians
important information about whether the drug is suitable for the
individual or subgroup within a species of animal. Additionally,
whenever manufacturers distribute a client information sheet, this means
that either the manufacturer or the CVM wishes to convey more facts
about safety or efficacy in lay terms to pet owners.
The staff at CVM monitors and evaluates adverse drug experience reports
and complaints of inefficacy for approved and unapproved, marketed
products. For approved products, this evaluation of postmarket safety
and efficacy incorporates knowledge gained from the premarket studies as
well as from scrutiny of peer-reviewed studies related to the drug, or
the disease that the drug is intended to cure or prevent.
From the hotline, we have learned that pet owners increasingly rely on
Internet sources for information when their pets have problems. They
have told us that, during their Internet searches, they often find label
information and client information sheets.
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.
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.
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.
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.
Product precautions, contraindications, safety information, and warnings
should help identify animal patients that are not good candidates for
the medication.
Labels change—if you have a large inventory of a product with a
long shelf life, you may want to contact the manufacturer or CVM to
obtain the most recent label. A long shelf life makes it likely that
some of the product won't be dispensed in the near future. Often, this
information is also posted on pharmaceutical companies' official Web
sites.
If you have comments or questions about this issue, contact Dr. Victoria
Hampshire at (301) 827-0158, or
VHampshi@CVM.FDA.GOV.
—Dr. Victoria Hampshire, Adverse Drug Events Coordinator, Office
of Surveillance and Compliance, FDA Center for Veterinary Medicine
Return to top
AVMA Journals | JAVMA News | Discussion Groups | Veterinary Career
Center
Professional Resources | Member Center | Care for Animals | AVMA Home
American Veterinary Medical Association
Copyright © 2004