Client Information Sheet for a FDA drug

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` PA: Client Information Sheet



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COMMENTS REGARDING

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 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 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.

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 provided 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]


http://www.avma.org/onlnews/javma/jan04/040115f.asp


Adverse drug event reports at the United States Food and Drug Administration Center for Veterinary Medicine

Victoria A. Hampshire, Frederick M. Doddy, Lynn O. Post, Teresa L. Koogler,
Tina M. Burgess, Priscilla O. Batten, Roderick Hudson, Dorothy R. McAdams,
and Margarita A. Brown

Journal of the American Veterinary Medical Association, August 15, 2004
(Volume 225, Number 4), pp. 533-536


FDA VETERINARIAN
MARCH/APRIL 2004

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


OPPOSITION TO CIS

Through various members of the state legislature who are supporting our efforts, we understand that the Board’s opposition to a written rule on this matter stems from the following mistaken views of this issue:

1. The requirement is not feasible because veterinarians repackage veterinary drugs and do not have access to Client Information Sheets.
2. Regulation is deemed unnecessary because current standards of practice require that veterinarians provide safety information.
3. The board believes that Client Information Sheets cannot be read intelligently by owners.
4. NSAIDs and similar drugs are safe because they have not been withdrawn from the market by the FDA.
5. This issue should be dealt with in the context of broad regulatory action on informed consent.

The Board notes that 49 Pa. Code s. 31.21, Principle 8 (related to drugs) provides for very specific prescribing, packaging and labeling requirements related to drugs, specifically:

Paragraph (d) This regulation also provides that the labeling provided by the veterinarian shall include "any cautionary statement specified by the veterinarian or required by law." [emphasis added]

Addressing the issues raised by the Board:

1. Repackaging
Every veterinary drug manufacturer has told the FDA that they have in place a system for providing veterinarians with all the Client Information Sheets they need. If that is not true, as the Board is asserting, then the solution is for the FDA to withdraw approval of bulk packaged drugs and only allow shipment of drugs in unit-of-use containers with the Client Information Sheet included in the manufacturer’s packaging.

Owners across the country are planning a Citizen’s Petition to the FDA asking that the agency withdraw approval of bulk packaging of any veterinary drugs which require a CIS on the basis that veterinarians claim, as the Board is doing here, that they do not have access to Client Information Sheets.

2. Current Standards
It is completely disingenuous to state that current practice standards require that veterinarians fully inform owners of potential side effects of drugs. The FDA has studied this issue and published an article on this in the August 15, 2004 issue of the Journal of the AVMA stating that veterinarians are NOT providing owners with vital safety information and this is a major factor in the adverse reactions reported to the agency. Day after sad day, animals are dying as a result of the failure of veterinarians to fully inform owners of potential problems with a select group of drugs.

If this is in fact already required, then there should be no objection to specifying that this requirement should be fulfilled by veterinarians ensuring that every drug which has a CIS is dispensed with a CIS. It makes no sense to leave this up to the whim of the individual veterinarian given that the nation’s experts in veterinary drug safety understand fully what information is required and how to present that information in a way that makes it understandable by owners of companion animals.

3. Owners are not intelligent enough to read a Client Information Sheet
Quite apart from the incredible hubris of a statement like this, the Client Information sheets are specifically designed by the FDA to provide owners with information that is vital to the safe use of the drug involved and written in a way that this information is generally intelligible by owners.

The FDA's experts have deemed that certain drugs can only be used safely if owners are provided with critical information about their safe use. They go to great lengths to develop and approve the Client Information Sheets so that they can be read by ordinary owners in light of the experience of the Center for Veterinary Medicine in their constant review of problems with these drugs.

Here are the FDA's own words describing a Client Information Sheet, in this case for the veterinary NSAID, EtoGesic:

Similar to Patient Prescribing Information (PPI), which is commonly distributed with human pharmacy prescriptions, the Client Information Sheet is written in "consumer-friendly" language and provides information in easily understood terms about the benefits and side effects associated with the use of NSAIDs and EtoGesic. This Client Information Sheet will supplement the information provided in the Package Insert. The Client Information Sheet will be printed on the reverse side of the Package Insert so that it is easy for pet owners to locate and read.
http://www.fda.gov/cvm/etogesicDDL.htm

It should be noted that the Client Information Sheet is an integral part of the legal product label and removing a Client Information Sheet causes the drug to be adulterated and unsafe.

4. NSAIDs and similar drugs are safe because they have not been withdrawn from the market by the FDA
The FDA has specifically stated that these drugs are safe only when owners are being given safety information:

The Center for Veterinary Medicine considers the approved veterinary nonsteroidal anti-inflammatory drugs (NSAIDS), including drugs classified as Cox 2 inhibitors, to be safe and effective when used according to the label and when dog owners are informed about common NSAID side effects. [emphasis added]
http://www.fda.gov/cvm/November2004.htm#5074

Since it is well known that owners are not being given vital safety information about the drugs being dispensed by their veterinarians, the FDA should in fact withdraw approval of these drugs.

5. Need for broader consideration
Having specifically said that Client Information Sheets should not be provided to owners because they are not intelligent enough to read them, the board says that if they were to deal with this issue, it should be in the broader context of regulation of informed consent.

To date, the FDA has received reports indicating that as many as 3,500 dogs may have died because of the side effects of NSAIDs alone. These reports generally represent less than 1% of actual events which means that as many as 350,000 dogs may have already died as a result of these drugs.

The solution to this problem is to simply make it clear that the Board expects veterinarians to provide owners with Client Information Sheets if the drug they are dispensing for home administration requires that this information be provided. If the Board chooses to do more, that is great. But the key issues in improving the safety of these drugs is ensuring that owners are given vital information that the FDA says is required for these drugs to be used safely.


SUMMARY

The issue is very simple:

The FDA has determined that the safe use of certain drugs requires that owners be given vital safety information in a form that the FDA approves that makes this information accessible to owners. Veterinarians must be required to provide this FDA-mandated, manufacturer-provided information to owners.

Signed:

Demitry Herman of Allentown, PA

Denise Dost of Philadelphia, PA




(Ed's note: The deadline for mailing in is 10/21/05 - - Hearing is 10/27/05)

May be emailed to: Teresa Lazo-Miller, Esq
General Counsel
tlazomille@state.pa.us



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