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IMPORTANT ANTIMICROBIALS TRANSITION TO PRESCRIPTION STATUS

Starts June 11th, 2023 – FDA GFI #263

WHY IS FDA ISSUING THIS GUIDANCE?

Guidance for industry (GFI) #263 is part of a broader effort by FDA to combat antimicrobial resistance (AMR), a serious threat to animal and public health. Antimicrobial use in humans, animals, and horticulture can contribute to the development of AMR. Using antimicrobials judiciously, in all settings, can help slow the rate at which AMR develops.

WHY DO I NEED TO CONSULT A VETERINARIAN TO OBTAIN THE SAMES DRUGS I’VE ALWAYS USED?

When animal drug sponsors make the voluntary labeling changes recommended in GFI #263, the relatively small number of medically important antimicrobial drugs that are currently available over the counter (OTC) would then require a veterinarian’s prescription (Rx). Obtaining these drugs under a veterinarian’s supervision can help guide the judicious use of antimicrobials and slow the development of AMR because veterinarians have specialized training and experience. Sometimes antimicrobial drugs may not be necessary for proper treatment or a different antimicrobial may be a better tool than the one you’re used to using. Providing animals with the most appropriate antimicrobial is more likely to effectively resolve the infection and reduce the need for repeated or extended courses of antimicrobial therapy. This will not only help to reduce AMR risks but will help to ensure better health outcomes for animals and can also save time and money.

IS YOUR VETERINARY-CLIENT-PATIENT RELATIONSHIP (VCPR) CURRENT?

What is a Veterinary-Client-Patient Relationship (VCPR)?

Utah law states that a licensed veterinarian must have a valid Veterinary-Client-Patient Relationship (VCPR) with you and your animal(s) in order to provide veterinary services. A valid VCPR cannot be established online, via e-mail, or over the phone. It can only be established by a veterinarian performing a physical examination of your animal.

A Veterinary-Client-Patient Relationship (VCPR) is valid when the following conditions exist:

  1. The licensed veterinarian must have sufficient knowledge of the animal to initiate at least a general or preliminary diagnosis of the medical condition of the animal.
  2. The licensed veterinarian has assumed the responsibility for making medical judgments regarding the health of the patient(s), the need for medical therapy and has instructed the client on a course of appropriate therapy.
  3. The client has agreed to follow the veterinarian’s recommendations.
  4. This means that the veterinarian has seen the animal within the last year and is personally acquainted with the care of the animal by virtue of a physical examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept (farm call).
  5. The veterinarian is readily available for follow-up evaluation, or has arranged for emergency or urgent care coverage, or has designated continuing care and treatment to another licensed veterinarian who has access to the patient’s medical records and/or can provide reasonable and appropriate medical care.
  6. The veterinarian provides oversight of treatment.
  1. Patient records are maintained.

The Utah Division of Provisional licensing oversees these requirements as the licensing agency for veterinarians and certified veterinary technicians in Utah.

Utah Administrative Code Sec. 58-28-102 (19); 58-28-604; R156-28-502(3)

 Useful links:

FDA GFI #263: Frequently Asked Questions for Farmers and Ranchers – Click Here!

AVMA News: Medically Important Antimicrobials Transitioning to RX Status Click Here!

FDA List of Approved New Animal Drug Applications Affected by GFI #263 Click Here!

 

Veterinary-Client-Patient Relationship (VCPR) – IT IS THE LAW

Kanab Veterinary Hospital occasionally receives calls from pet and animal owners asking for clarification as to why their animal is required to have a health exam prior to a prescription being filled, a vaccine being administered, or other health services being performed.  The VETERINARIAN-CLIENT-PATIENT RELATIONSHIP (VCPR) are the rules we follow and form the basis for veterinary care which is critical to the health of your animal.

What is a Veterinary-Client-Patient Relationship (VCPR)?

Utah law states that a licensed veterinarian must have a valid Veterinary-Client-Patient Relationship (VCPR) with you and your animal(s) in order to provide veterinary services. A valid VCPR cannot be established online, via e-mail, or over the phone. It can only be established by a veterinarian performing a physical examination of your animal.

A Veterinary-Client-Patient Relationship (VCPR) is valid when the following conditions exist:

  1. The licensed veterinarian must have sufficient knowledge of the animal to initiate at least a general or preliminary diagnosis of the medical condition of the animal.
  2. The licensed veterinarian has assumed the responsibility for making medical judgments regarding the health of the patient(s), the need for medical therapy and has instructed the client on a course of appropriate therapy.
  3. The client has agreed to follow the veterinarian’s recommendations.
  4. This means that the veterinarian has seen the animal within the last year and is personally acquainted with the care of the animal by virtue of a physical examination of the animal or by medically appropriate and timely visits to the premises where the animal is kept (farm call).
  5. The veterinarian is readily available for follow-up evaluation, or has arranged for emergency or urgent care coverage, or has designated continuing care and treatment to another licensed veterinarian who has access to the patient’s medical records and/or can provide reasonable and appropriate medical care.
  6. The veterinarian provides oversight of treatment.
  1. Patient records are maintained.

The Utah Division of Provisional licensing oversees these requirements as the licensing agency for veterinarians and certified veterinary technicians in Utah.

Utah Administrative Code Sec. 58-28-102 (19); 58-28-604; R156-28-502(3)

Why is an exam needed before vaccines are administered?

Since animals age far faster than humans, a yearly exam can detect health issues that are not readily apparent to the owner. Vaccinating an unhealthy animal may exacerbate the animal’s ill-health or the vaccine may be ineffective. To make an analogy to human health; patients are often asked how they are feeling to ensure that they are in good health before receiving a vaccination. For instance, human patients may not be given a flu shot while they have an active fever. Because animals cannot tell us how they are feeling, an exam is important prior to administering vaccinations.