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Tuesday, March 3, 2015

Check the validity of your VCPR for future needs

by Kerry Halladay, Editor

— Impending standards for antibiotic use requires vets

Quick; what is a VCPR and do you have a valid one?

If you didn’t mentally rattle off “veterinary-client-patient-relationship” as you read that, you might want to give your vet a call. If you don’t have a vet, it would behoove you to find one soon.

Why? Because a good portion of medicated feeds will soon require a veterinary feed directive (VFD) to be created or used. And you can’t get a VFD without a good relationship with your herd vet.

As of January 2017, medicated feeds including “medically important antimicrobials” will require a VFD to be created or sold to producers.

H.B. Green, with Elanco Animal Health, speaking at the 30th Annual Southwest Nutrition and Management Conference held recently in Tempe, AZ, explained VFDs to the audience of producers and livestock veterinarians.

“So what is a VFD? A VFD is a Veterinary Feed Directive. It’s used under the current regulatory guidelines.

The program was actually started in 1996. They put it into the law and then in early 2000s they said ‘OK, we now have funding, so we’re going to start to look at that and start to implement that.’” VFDs are part of the implementation of the Food and Drug Administration’s (FDA’s) efforts at curbing the spread and intensity of antimicrobial resistance in the population. As such, the focus is on so-called medically important antibiotics, namely, where human medicine and animal medicine overlap.

“Basically all antibiotics that are shared class—so they’re used in human medicines like your tetracyclines and your cephalosporins that are also used in animals— will require a VFD,” Green summed up.

The VFD process started out as a voluntary compliance, then moved to make it mandatory when there was little voluntary activity. This elicited the participation of all of the 25 animal pharmaceutical companies.

“Now, until the final implementation, the 25 companies have to get their products in, have to get them relabeled, and certified for the VFD process,” Green said.

“The big thing about that is it keeps the food producers having access to feed-grade antibiotics. It’s just the way that they are used and the key phrase of “medically important” that are the key differences there on how and when you can use a particular therapeutic.”

Buildup and implementation

The VFD process has been outlined in a pair of industry guidances; Guidance for Industry #209 and Guidance for Industry #213. These two outline the “what” and “how” elements of the process. But the process that is to be implemented in 2017 needs some tinkering and that is where 21 CFR 558 comes in.

“[21 CFR 558] aims to modernize the VFD process,” read Green’s conference paper. “It is an effort to streamline procedures while providing greater oversight. While the VFDs have been used for over 10 years for certain products, with this great increase in the number of antibiotics moving to VFD status, this modernization will be critical for practicality and to lessen the possibility that needed antibiotics will be denied due to the paperwork mechanics.”

During his presentation, Green gave some examples of where some of this improvement will likely come.

For example, as it stands currently, any product that is VFD would become a “category 2” product, which would require a medicated feed license to make. Green noted that there are less than 1,000 medicated feed mills in the country and such a sudden shift in the demand volume would result in chaotic situations. The 21 CRF 558 will likely change that current requirement in light of the difficulties it would cause.

Another example of a current requirement for the 2017 implementation that will likely be streamlined away is the need to retain VFD copies for two years. Green said it is likely that requirement will return to current VFD procedures which only require one year retention.

But at the core the function will remain the same.

“The VFD requires a written form that is filled out by the veterinarian. The veterinarian just can’t sign a page and give it to you and say ‘hey, you fill it out at the mill.’ They are responsible to make sure that it is complete. If it’s not complete, the distributor or the manufacturer cannot make the feed and the client can’t use it. And you can’t call up and say ‘fill out the VFD for me and I’ll sign it later.’ That’s not the way the rules are written. But that VFD does authorize the feed mill operator or distributor to give that feed to the client containing the drug, used only for its intended purposes and its intended label.”

What is covered?

There are three general classes of antibiotics: animal only; human only; and both animal and human. The VFD requirement will only impact this latter class. Animal-only antibiotics—these include ionophores, polypeptides, carbadox, bambermycins, and pleuromutilin—are not included. Green also pointed out that shared-class antibiotics where the human use is restricted to topical products only are also not included.

Drugs that will now be covered include penicillins, cephalosporins, quinolones, fluoroquinolones, tetracyclines, and sulfas. Additionally, the use of these drugs are to be restricted to therapeutic use only, namely treating sick animals diagnosed with an illness, controlling the spread of an illness in the herd, and/or preventing illness in healthy animals. These uses, via the VFD, must be under the supervision of a veterinarian.

According to Green’s paper, for a VFD, a veterinarian must:

• Have a valid veterinary license in the state where the animals being fed the medicated feed are located;

• Have a valid VCPR with the herd being fed the VFD feed. The requirements of a VCPR may vary from state to state;

• Completely and accurately fill out and sign the VFD orders. Vets may electronically sign if using an electronic VFD (eVFD) process. A eVFD must be sent using a computer system that is compliant with Title 21, Part 11 of the Code of Federal Regulations (21 CFR 11). Telephone orders are not allowed;

• Provide the feed mill or distributor with the original VFD order. Vets can fax or scan and email a signed order to the feed mill but then must provide the original signed VFD order within five working days. An eVFD has an authorized electronic signature and therefore no follow-up paper copy is required;

• Provide the producer with a copy of the VFD or eVFD order;

• Keep a copy of the VFD order for a minimum of two years (likely to change to one year); and

• Have the VFD orders available for an FDA inspection.

This returns the issue back to the VCPR issue and why it’s so important. Without a VCPR, there can be no VFDs. With no VFDs, there will be no access to certain antibiotics by 2017. So it is in producers’ best interest to brush up on their VCPRs and make sure they are valid.

According to the American Veterinary Medical Association Principles of Veterinary Medical Ethics, it is unethical for a vet to write a prescription without a valid VCPR. What counts as valid differs from state to state.

“It’s all about the relationship: the ‘R’ determines the VCPR validity,” explains Sandy Stuttgen, DVM, and a member of the University of Wisconsin’s Extension beef team, in a recent Extension fact sheet.

“Do your cattle have access to a veterinarian who: knows them, their owner, and their facility; has assumed the responsibility for their health care; has experience with local issues that may impact them; develops disease prevention protocols and a treatment protocol book specific to their needs as well as helping make considerate end-oflife decisions; and is available for follow-up care?” Your answer should be “yes.” If not, take the steps now to make sure the answer is “yes” so January 2017 doesn’t come as a nasty shock. — Kerry Halladay, WLJ Editor

 
 


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