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Understanding the new drug regulations

Vet Advice with Dr. Ron Clarke

New regulations governing the purchase and use of antimicrobials (antibiotics) necessitate time spent between veterinarians and producers. Everyone has an opinion. Phrases like “prudent use,” “veterinary-client-patient-relationships,” “veterinary-pharmaceutical stewardship,” “veterinary oversight,” and “documented evidence” pepper the pages of government, academic and veterinary documents issued around antimicrobial use. There is a new vocabulary to be learned, the implications of which many producers and service providers in food-animal agriculture, including veterinarians, either misconstrue or interpret incorrectly.

  • Read more: Do you have a veterinary-client-patient relationship?

If the industry is going to be seen as doing the right thing, a common language is needed. There should be no question why antimicrobial resistance (AMR) is an issue and why agriculture needs to be part of answering questions when they use 80 per cent of the antimicrobials produced. It’s frightening when people die following surgery or after injury because bacterial infections resist any and all treatment. Questions do remain about the degree agriculture plays versus the role played by humans and the medical community. There are burning questions about environmental interaction when antimicrobials are used indiscriminately.

There is no point in thinking that change will come slowly because significant change is around the corner even though new regulations address issues that have been on federal government dockets for nearly two decades. The learning curve will be steep. Situations and circumstances exist for which answers are still missing — things like prevention of disease in feedlots and swine operations based on proper management of the immune system, and use of vaccines versus treatment using broad-spectrum antimicrobials. These and other important questions beg resolution. Almost assuredly, quick answers to important questions err on the side of safety and may need to be rethought.

2018 will be a grace period of sorts. Veterinarians and their clients must figure out how these new regulations fit with individual operations. There is no reason not to believe that revamping how we buy, sell and use antimicrobials will involve an additional financial burden, and be construed as an operational inconvenience based on old habits. Bitterness will work its way into the system as the freedom to use drugs in treating and preventing disease becomes more restrictive than we have come to know. Veterinarians, on one hand, will be targeted with petitioning control yet remain under the gun to issue prescriptions appropriately and maintain accurate records showing that clients have been properly instructed on antibiotic use and withdrawal times. In the event mistakes are made, veterinarians will be obligated to be front and centre in engineering solutions and developing protocols to prevent potential problems in the future. The legality of how business is conducted on a day-to-day basis is about to become more acute.

Understanding all aspects of change requires consideration of individual pieces first, then fitting them together. A critical aspect of compliance with new regulations is understanding the concept of a veterinarian-client-patient-relationship. A valid veterinarian-client-patient-relationship (VCPR) must exist before a veterinarian can prescribe or dispense medication. Two additional issues in Canada need to be discussed with a veterinarian: the import and use of active pharmaceutical ingredients (AIP) and the import of drugs for use by individual producers (OUI).

The following are excerpts from documents published by the Canadian Veterinary Medical Association and several provincial veterinary associations.

A legitimate VCPR is considered to exist only if medical records of the practice contain sufficient evidence of relevant and timely interaction between the veterinarian, animal owner and animal patients.

Interactions include, but are not limited to: farm or home visits, clinic appointments, consultations, direct animal examinations (individual or herd/flock), laboratory reports, production record reviews, etc.

The VCPR is supported by documented evidence that the veterinarian has undertaken steps necessary to establish medical needs, and consequently prescribes and subsequently dispenses pharmaceuticals.

The VCPR is not a signed contractual agreement but rather a working connection and interaction between veterinarian, client and specific animal patient or group of animals. The VCPR is not in and of itself an entitlement to prescribe and subsequently dispense.

Each provincial and territorial veterinary statutory body has its own definition of VCPR in provincial legislation. Veterinarians with clients in more than one province need to be aware of the differences and ensure clients are aware of them.

The CVMA’s Antimicrobial Prudent Use Guidelines (2008) states that a VCPR exists when the following conditions have been met:

1. The veterinarian has assumed the 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 for followup evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regimen.

Changes to federal policies and regulations in 2016 resulted in the removal of all production claims for antimicrobials in animal feed and water. The shift led to mandatory veterinary oversight of antimicrobial use in food-producing animals.

The website on Veterinary Oversight of Antimicrobial Use produced by the CVMA and provincial associations is mandatory reading for veterinarians and their clients.

The document outlines standards of antimicrobial use covering: active pharmaceutical ingredients (AIP), own use imports (OUI), veterinary stewardship, classification of medically important antimicrobials, prescription preparation and documentation, extra-label use of antimicrobials, information related to labelling and dispensing of antimicrobials, compounding, medical records, surveillance.

About the author

Columnist

Dr. Ron Clarke prepares this column on behalf of the Western Canadian Association of Bovine Practitioners. Suggestions for future articles can be sent to Canadian Cattlemen ([email protected]) or WCABP ([email protected]).

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