Managing on-farm drug usage (OTC, LDU, ELDU) (Proceedings)

Supervision of the drug usage on the dairy is a foundation stone for achieving the VCPR and is referenced frequently in the regulatory documents that we are obligated to comply with. In 1996 the Animal Medical Drug Usage Clarification Act (AMDUCA) became the law that regulates extra-label drug usage (ELDU). In Wisconsin a guide was developed to help our dairy veterinarians incorporate this law into their daily practice. Early in 2000 Wisconsin developed a software program as a tool to aid in organizing basic information about reconciling past drug usage, organizing the drug protocols used in treatment plans, and a software for preparing the prescriptions for the drugs used on the dairy based on past usage and expected future needs.

Two requirements from AMDUCA; by or under the supervision of a veterinarian and in the presence of a valid VCPR; served as the emphasis in the development of this program. The objective was to develop four parts; reconciliation of drug usage on a dairy, a template for a written treatment plan for the dairy employees responsible for health care delivery (seen in written protocol section), prescriptions of drugs for the dairy in responsible quantities, and a records plan that enables the holder of the VCPR to efficiently supervise all treated animals and assume the responsibility for treatment failures. Best practices Wisconsin achieved 3 of the 4 (reconciliation, protocol writing, and prescriptions) with interactive software to the drug list for a practice.

The records portion is still under development. Organizing individual cow recordings has been and will be the thread that runs through the levels of cow and personnel supervision and our consulting on production medicine decisions for the dairy.

As we were developing the treatment protocols we initiated a 1 defined condition / 1 treatment / 1 recording plan. To keep the recording simple we included only information at the cow side recording that had value for the management either by the cow side personnel or by management for the care of the cow. Our effort to keep the recording simple does improve record keeping compliance which does meet the intent of the law, but as proposed it does not meet the letter of law using the AMDUCA records requirement as our yard sick. The AMDUCA records requirement is ID, species, number treated, condition, drug name, dosage, duration, and withdrawals. Obviously we need to meet the letter of the law while we are keeping the recording system simple and seamless cow side.

As we were writing treatment protocols we developed two layers of protocols, the simple top down protocol for cow side workers that serves for the simple easily defined cases and then an in depth protocol for the responsible person that gives additional instructions and can incorporate the information that meets the letter of the law into either the written treatment instructions or the drug protocol while we keep cow side recording simple and limit it to information that has value in managing the cow.

Figure 1 Spectramast treatment protocol from Best Practices Wisconsin

Figure 1 Spectramast treatment protocol from Best Practices Wisconsin

Notice the last line of the drug protocol added the exit recording entry that potentially has a lot of value for the management of the economic aspects of the treatment protocol as our method of meeting the letter of the AMDUCA records requirement about doses. This addition to the recording plan, which we needed to meet the letter of the law, is likely to be met with resistance unless we can include some information that has true value to the dairy such as also including days out of the tank.

The writing of treatment protocols was initiated by a questionnaire of conditions the dairy treated, drugs used on the dairy and desired outcomes.

Figure 2 – questionnaire to prepare for written protocol preparation

Accounting for the mild cases for each condition was the critical step for supervision of drug usage, especially label usage. Next we need to plan the drug protocols for moderate and severe cases. These are a fact of life that will need to have either a drug protocol plan or instructions to seek professional care. The questionnaire gives us information about what is currently. If treatments are not currently medically appropriate we need to replace the therapies with a new plan and then prove the changed treatment plan is superior.

Superior could be:

         Equal but with improved food safety

         Improved as defined by judicious drug usage

         Improved clinical effectiveness

         Improved economic effectiveness

The drug protocol for moderate and severe may well reach ELDU. AMDUCA is written to regulate extra label drug the use and its algorithm gives us the sound template for drug choices when ELDU is a consideration.

AMDUCA withdrawal times are our responsibility to determine through FARAD or scientific information.

Demonstrating clinical effectiveness is the mission since it is the measure that the AMDUCA algorithm uses as our justification to progress through the layers of drug choices in to establish a clinically effective therapy for the cows.

There is one problem with this algorithm which is not actually a problem of the algorithm; the problem is the perception that all treatment failure should be labeled drug failure. Before we try to apply this algorithm we need to first define clinically effective for the various condition definitions that have drug protocols and establish a satisfactory success level. Second we need to have investigated and eliminated the other factors that affect treatment response such as failure to detect mild cases, etc.

This doesn't mean there isn't a plan B for some cows; it means that plan A may be satisfactory for some defined subsets and our accountability of early detection of mild cases and establishing a medically appropriate treatment protocol becomes the real objective of drug usage on the dairy. This makes our detection and involvement with problem cows a more significant protocol than an ELDU protocol for cows that didn't need it.

The VCPR tenant that "The veterinarian ....is personally acquainted with the keeping and care of the animal" should really direct us to first consider factors that impact clinical effectiveness that have nothing to do with the drug selection first. It is eye opening to see how many condition definitions are treatable with label treatments when unrealistic expectations are replaced with realism and the detection and examination portion of the SOP that leads to a treatment decision eliminates treatments of untreatable animals that would be held up as drug failures.

There are scenarios where the labels on the drugs don't meet the needs of a cow, but ELDU can be the exception not the rule. A word of caution, we said we wanted to present a superior drug protocol and prove it. At the farm level we are not "proving" anything. We are utilizing the records to see if we are satisfied. We are not comparing treatment protocols, which would require a carefully structured field study. We are satisfying ourselves that the protocol satisfies our goal for the welfare of the cow and the food safety for the consumer. Odds are this will also make it economically sound for the dairy.

In managing the drug usage it seems the most important diagnostic process is watching for protocol drift. Drift is not bad unless we fail to detect it by supervising cows under treatment. It signifies dissatisfaction with the current treatment protocol. Resolving it means someone is going to learn something. It may be the workers, or the owners, or a team member, or us. No matter what, it is the time to get everyone on the same page.

Annual drug reconciliation is an invaluable check and balance for the drugs that we used, planning the prescriptions for next year and considering the business aspect to the recommendations we make. The Best Practices software has been a useful tool for accomplishing this.

The prescription tool allows us to use the information about the amounts used in the past with our assessment of what we plan for the future to create a prescription of each drug that contains the required drug information, the label instructions, and any extra label uses sanctioned for that drug.

Accomplishment of accountability of judicious use of drugs has been the ultimate goal. This accountability has to be developed into the records plan for the dairy. The accomplishment is actually by the use of the records to be able to supervise treatments while they are occurring so that we have assurance that we are achieving drug usage on:

         Right cow – accountable by recording of all severities especially mild cases

         Right time – demonstration of early detection of conditions

         Right drug- demonstration of clinical effectiveness of treatments

         As short as we can – use of assessment of clinical signs to determine duration of treatment

         As long as we should – use of medical history and identification of problem cow to extend duration on an as needed basis

In summary, the development of a herd health plan that utilizes the SOP, the written treatment plan, and the record system to establish timely supervision of both routine treatments and the recognition and supervision of problem cow care is the heart of drug usage supervision. Reconciliation of drug usage is a key check and balance for accountability of our previous actions and allows the economics of treatments to remain relevant.

Conclusion

• Our simple cow side recording plan did not meet the letter of the law for Complying with AMDUCA record requirement, but we can incorporate the missing recordings into the comprehensive treatment plan and drug protocol.

• The AMDUCA algorithm will help make medically appropriate drug choices possible for extra label drug usage based on satisfaction of the clinical effectiveness of the plan

        o However the algorithm assumes the drug choice is the reason for clinically ineffective treatments. The other reasons need to be eliminated before ELDU.

        o The conditions treatable with label treatments need to be differentiated from the untreatable conditions when making label versus extra label drug choices

• Protocol drift is an indication of protocol dissatisfaction and needs to be investigated.

• Annual drug reconciliation is an invaluable check and balance for supervising drug usage.