FDA Emerging issues regarding informed consent

Electronic medical records (EMRs) hold great promise for improving the practice of evidence based medicine by facilitating communication between members of the health care team. The most profound influence of EMRs may lie in their ability to encourage clients' involvement in their own pets care.

FDA Emerging issues regarding informed consent

Postby malernee » Tue Aug 03, 2004 11:34 am

January 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.
malernee
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fda Reports Lead to Label Changes avma article

Postby malernee » Tue Aug 03, 2004 2:59 pm

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
malernee
Site Admin
 
Posts: 462
Joined: Wed Aug 13, 2003 5:56 pm

Informed Consent Doctrine

Postby malernee » Fri Nov 05, 2004 12:55 pm

The Informed Consent Doctrine: What Veterinarians Should Tell Their Clients
J Am Vet Med Assoc 224[9]:1436-1439 May 1'04 Veterinary Medicine and the Law 0 Refs

* D. Duane Flemming, DVM, JD, DACVO and John F Scott, DVM, JD
* Contra Costa Animal Eye Clinic, 2100 Monument Blvd, Ste 7, Pleasant Hill, CA 94523-3440
In many veterinary practices today, obtaining informed consent consists of the receptionist placing a consent form in front of the client and telling the client that he or she needs to sign the form so the doctor can perform the surgery or treat the animal. Properly obtaining informed consent, however, involves more than simply obtaining the client's signature on a consent form. In particular, ensuring that the client is properly informed is a vital part of obtaining informed consent.
malernee
Site Admin
 
Posts: 462
Joined: Wed Aug 13, 2003 5:56 pm


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