Prescription Inserts became Project 2000 when veterinary medicine became "big business" and many vets became corporate managers, dispensing drugs without advising owners of potential side effects. Good for business but NOT an easy pill to swallow!
Vets Ignore FDA's CIS Guidelines
Too many veterinarians refuse or fail to provide CSI (Client Information Sheets) to animal owners who don't know prescription inserts are available as in human prescription medicine.
re: Draft 16A-5721 - Professional Conduct
October 18, 2005
To: Pennsylvania State Board of Veterinary Medicine
Board Administrator - Bob Kline
2601 North Third Street - P.O. Box 2649
Harrisburg, PA 17105-2649
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 applaud 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 in Pennsylvania 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.
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.
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.
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:
Given these findings, we have the following reminders for practitioners:
The Attorney's name has since retired and we've removed his name but this appeal was and is backed by this site (see below) and is no less significant today.
The bottom line in veterinary practice and human medicine is simple... You are legally entitled to a copy of the Client Information Sheet - YOU are the client.
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