Vets Ignore FDA's CIS Warning Guidelines

re: Draft 16A-5721 Professional Conduct

October 18, 2005

To:  Pennsylvania State Board of Veterinary Medicine

(State Director and address redacted)

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 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 provide 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.

http://www.fda.gov/cvm/index/fdavet/2004/Mar-Apr04.pdf

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]

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