Tuesday, September 18, 2012

Louisiana Board of Veterinary Medicine Rules and Regulations Relating to Prescriptions


Louisiana's Principles of Veterinary Medical Ethics of the American Veterinary Medical Association (AVMA)

III.     THE VETERINARIAN - CLIENT – PATIENT RELATIONSHIP

A.     The veterinarian - client - patient relationship (VCPR) is the basis for interaction among veterinarians, their clients, and their patients.  A VCPR exists when all of the following conditions have been met:

(1)   The veterinarian has assumed responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions.

(2)   The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s).  This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s), or by medically appropriate and timely visits to the premises where the animal(s) are kept.


(3)   The veterinarian is readily available, or has arranged for emergency coverage, for follow-up evaluation in the event of adverse reactions or the failure of the treatment regimen.

B.     When a VCPR exists, veterinarians must maintain medical records (See section VII).

C.     Dispensing or prescribing a prescription product requires a VCPR.

(1)   Veterinarians should honor a client’s request for a prescription in lieu of dispensing.

(2)   Without a valid VCPR, veterinarians’ merchandising or use of veterinary prescription drugs or their extra-label use of any pharmaceutical is unethical and is illegal under federal law.

VI.      THERAPIES

A.     Attending veterinarians are responsible for choosing the treatment regimens for their patients.  It is the attending veterinarian’s responsibility to inform the client of the expected results and costs, and the related risks of each treatment regimen.

B.     It is unethical for veterinarians to prescribe or dispense prescription products in the absence of a VCPR.

C.     It is unethical for veterinarians to promote, sell, prescribe, dispense, or use secret remedies or any other product for which they do not know the ingredient formula.

D.    It is unethical for veterinarians to use or permit the use of their names, signatures, or professional status in connection with the resale of ethical products in a manner which violates those directions or conditions specified by the manufacturer to ensure the safe and efficacious use of the product.

XI.      GLOSSARY

A.     PHARMACEUTICAL PRODUCTS
Several of the following terms are used to describe veterinary pharmaceutical products.  Some have legal status, others do not.  Although not all of the terms are used in the Principles, we have listed them here for clarification of meaning and to avoid confusion.

(1)   Ethical Product:  A product for which the manufacturer has voluntarily limited the sale to veterinarians as a marketing decision.  Such products are often given a different product name and are packaged differently than products that are sold directly to consumers. “Ethical products” are sold only to veterinarians as a condition of sale that is specified in a sales agreement or on the product label.

(2)   Legend Drug:  A synonymous term for a veterinary prescription drug.  The name refers to the statement (legend) that is required on the label (see veterinary prescription drug below).

(3)   Over the Counter (OTC) Drug:  Any drug that can be labeled with adequate direction to enable it to be used safely and properly by a consumer who is not a medical professional.

(4)   Prescription Drug:  A drug that cannot be labeled with adequate direction to enable its safe and proper use by non-professionals.

(5)   Veterinary Prescription Drug:  A drug that is restricted by federal law to use by or on the order of a licensed veterinarian, according to section 503(f) of the federal Food, Drug, and Cosmetic Act.  The law requires that such drugs be labeled with the statement:  “Caution, federal law restricts this drug to use by or on the order of a licensed veterinarian.”

B.     DISPENSING, PRESCRIBING, MARKETING AND MERCHANDISING

(1)   Dispensing  is the direct distribution of products by veterinarians to clients for use on their animals.

(2)   Prescribing is the transmitting of an order authorizing a licensed pharmacist or equivalent to prepare and dispense specified pharmaceuticals to be used in or on animals in the dosage and in the manner directed by a veterinarian.

(3)   Marketing  is promoting and encouraging animal owners to improve animal health and welfare by using veterinary care, services, and products.

(4)   Merchandising is the buying and selling of products or services.


Prescribe, Prescribing or Prescription—an order for any drug, medicine, chemical or controlled substance provided by a veterinarian licensed by the board, stemming from the veterinarian-client-patient relationship, that is patient specific, which is either:
1.    dispensed or administered by the prescribing veterinarian;
2.    dispensed by a veterinarian licensed by the board other than the prescribing veterinarian; or
3.    written, electronically communicated or given orally to a registered pharmacist to be filled, compounded or dispensed by the pharmacist in a registered pharmacy.


G.   Providing Prescriptions

1.    A client is not obligated to purchase a prescription medication from the prescribing veterinarian. Therefore, when a veterinarian-client-patient relationship exists and a veterinarian has determined that a prescription medication will be used in a patient's treatment or preventive health plan, it shall be considered a violation of the rules of professional conduct, within the meaning of R.S. 37:1526(14), for a veterinarian to refuse to provide a written prescription to the client so long as the following conditions exist:
a.     the veterinarian has determined that the patient's life is not endangered without the immediate administration of the prescription medication; and
b.    in the veterinarian's medical opinion, the prescribed substance is medically safe for in-home administration by the client.
2.    A veterinarian shall not be required under §705 to write a prescription for controlled substances or a prescription for any medication that, in the veterinarian's medical judgment, is not appropriate for the patient's medical care.
3.    A veterinarian may refuse to write a prescription under §705 if it is not directly requested by a client with whom a veterinarian-patient-client relationship exists.
4.    A written prescription can be construed to include any manner of authorization for filling a prescription, including verbal or electronic communication.
H.   It shall be a violation of the rules of professional conduct under R.S. 37:1526(14) for a veterinarian in the course of his veterinary practice to use or dispense any products, including drugs, which are expired.
I.     It shall be a violation of the rules of professional conduct under R.S. 37:1526(14) for a veterinarian to be in possession of drugs or other medical products which are over six months past their expiration date unless the materials are obviously removed from use and it can be documented that said drugs are in the process of being returned or otherwise disposed of.
J.     Only a veterinarian licensed by the board may prescribe any drug, medicine, chemical or controlled substance for a patient after the establishment of the veterinarian/client/patient relationship, with the exception of the delegation of such authority pursuant to Subsection M below.
K.   The veterinarian is responsible for and shall maintain accurate medical records when prescribing any drug, medicine, chemical or controlled substance which includes the following:
1.    client's name;
2.    patient's name;
3.    date of prescription;
4.    name of drug;
5.    usage dosage including the route of administration;
6.    quantity dispensed and number of refills;
7.    name of veterinarian prescribing the drug, medicine, chemical or controlled substance;
8.    telephone calls changing the prescription or dosages must be recorded in the medical record of the patient; and
9.    refill information must be recorded on the prescription and in the medical record of the patient.
L.    The initial prescription of a legend drug shall be communicated personally or by telephone to the pharmacy by the veterinarian. The initial prescription and any refills of a controlled drug shall be communicated personally or by telephone to the pharmacy by the veterinarian. A written prescription for a controlled drug shall be personally prepared by the prescribing veterinarian. A written prescription for a controlled drug shall be handwritten or typed, and shall contain the specific client/patient’s names (or identifying information if herd, etc.) and the drug(s) prescribed with usage directions, appropriate government registration numbers, dated, and signed by the prescribing veterinarian, affixed with his signature stamp, or electronic signature thereon if transmitted electronically to a pharmacy. However, the use of a signature stamp or electronic signature will have the presumption the prescribing veterinarian knows of, and has personally provided, the prescription for the use of the patient.
M.   The veterinarian may delegate to an office employee the authority to communicate a refill of a legend drug to the pharmacy on behalf of the veterinarian pursuant to written protocol established prior to the delegation of such authority.
N.   The written protocol required in Subsection M above shall be maintained on the premises as part of the prescribing veterinarian's facility procedure and shall include, but not be limited to, the following:
1.    an authorization dated and signed by the veterinarian delegating specific authority to the office employee;
2.    the authorization shall be for a stated limited period;
3.    the authorization shall specify the exact nature and extent of the delegation of authority;
4.    the medical record of the patient shall be documented to show the exercise of the delegated authority at the time the office employee communicates to the pharmacy the order to refill;
5.    the office employee who has the delegated authority and the veterinarian shall sign the written protocol; and
6.    the written protocol shall be made available to the pharmacy at issue on request.
O.   A veterinarian licensed by the board may lawfully prescribe and/or dispense Rompun (legend drug), Telazol (controlled substance), and/or Ketamine (controlled substance), or a mix of these drugs, to a deer farmer licensed by, and in good standing with, the Department of Agriculture and Forestry only under the following terms and conditions.
1.    For the purpose of this Section, deer, deer farmer, and deer farm operation shall apply to cervids only which are further exclusively defined as imported exotic deer and antelope, elk and farm raised white tail deer as defined in R.S. 3:3101 et seq.
2.    The veterinary-client-patient relationship must first be established, and thereafter maintained, as defined in §700 and §705.A.2.
3.    The veterinarian shall be familiar with the deer farm operation at issue and have general knowledge of the species and numbers of animals on the premises.
4.    The licensed deer farmer shall personally maintain a perpetual written inventory of the drugs referenced in this Section, including the following information:
a.     name of drug and date purchased;
b.    name and address of veterinarian the drug was purchased from and a written receipt;
c.     amount purchased;
d.    date of each use;
e.     amount used for each administration;
f.     reason for each administration;
g.     the identity of each animal by electronic device, tattoo and/or tag upon capture; and
h.    the date and amount of drug wasted, spilled or lost.
5.    The licensed deer farmer shall comply with all state and federal laws regarding the storage of the drugs, and the perpetual written inventory, in a double locked container when not in use.
6.    The licensed deer farmer who obtains the drugs from the veterinarian shall be the only person allowed to use or administer the drugs on his deer and for capture purposes only.
7.    Prior to obtaining the referenced drugs, the licensed deer farmer must successfully complete a board approved chemical capture course. The veterinarian prescribing and/or dispensing the drugs must initially obtain and maintain in his records a copy of the deer farmer's current license issued by the Department of Agriculture and Forestry and a copy of the licensed deer farmer's current certificate verifying successful completion of the chemical capture course approved by the board. The licensed deer farmer must successfully complete a board approved chemical capture course every three consecutive calendar years.
8.    The veterinarian may only lawfully prescribe and/or dispense the drugs referenced herein in minimal quantities based on the size of the herd at issue and the history of prior use, if applicable, of the drug or drugs requested by the licensed deer farmer.
9.    Upon requesting a refill of, or an additional permissible amount of a drug, the licensed deer farmer shall provide to the prescribing and/or dispensing veterinarian a copy of the deer farmer's current license issued by the Department of Agriculture and Forestry, a copy of the current certificate verifying successful completion within the last three consecutive calendar years of the chemical capture course approved by the board, and a copy of the perpetual written inventory, as well as return all empty or sealed containers of the drugs in the case of a refill. The copy of the deer farmer's current license, the copy of the current certificate verifying successful completion within the last three consecutive calendar years of the board approved chemical capture course, the copy of the perpetual written inventory, and all empty or sealed containers shall be kept by the veterinarian for his record keeping purposes as required in §701.
10.  Any prescribing and/or dispensing veterinarian who has reason to believe that a licensed deer farmer is not in compliance with the items and conditions of this Section, or is otherwise abusing the privileges established by this Section, shall notify, in writing, the board and the Department of Agriculture and Forestry immediately.
11.  The prescribing and/or dispensing veterinarian shall comply with all state and federal laws and/or regulations regarding the prescribing and/or dispensing of Rompun (legend drug), Telazol (controlled substance), Ketamine (controlled substance), or a mix of these drugs, to a deer farmer licensed by, and in good standing with, the Department of Agriculture and Forestry.
12.  Any prescribing and/or dispensing veterinarian who violates, or otherwise fails to comply with this Section, or any part thereof, including all state and federal laws and/or regulations, shall be guilty of unprofessional conduct within the meaning of R.S. 37:1526(14).
AUTHORITY NOTE:    Promulgated in accordance with R.S. 37:1518.
HISTORICAL NOTE:   Promulgated by the Department of Health and Human Resources, Board of Veterinary Medicine, LR 6:71 (February 1980), amended by the Department of Health and Hospitals, Board of Veterinary Medicine, LR 16:225 (March 1990), LR 19:1329 (October 1993) LR 20:1381 (December 1994), LR 23:1686 (December 1997), LR 24:1932 (October 1998), LR 25:1249 (July 1999), LR 25:1627 (September 1999), LR 27:51 (January 2001), LR 30:797 (April 2004), LR 37:1571 (June 2011).
A.   It is the responsibility of the veterinarian to label all medications and/or other veterinary products as dispensed. This label must include the following:
1.    name, address and telephone number of clinic;
2.    name of veterinarian dispensing medications;
3.    patient name and client name;
4.    name of medication and/or other veterinary product dispensed;
5.    quantity and strength of product;
6.    directions for administration;
7.    date dispensed; and
8.    precautionary statements as required by law, i.e., not for human consumption, poisonous, etc.
AUTHORITY NOTE:    Promulgated in accordance with R.S. 37:1518.
HISTORICAL NOTE:   Promulgated by the Department of Health and Hospitals, Board of Veterinary Medicine, LR 16:226 (March 1990), LR 19:1329 (October 1993).

Entire statutes and rules can be found here





No comments: