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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

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