Antibiotic Stewardship and Veterinary Medicine

Alternate Title

Regimen Rage from a Clinical Pharmacologist

The carconnection.com

The Basics of Clinical Pharmacology (in one slide)

•Can I do some good?

•Can I do any harm?

•Can I get it in the animal(s)?

•What is the cost?

Stewardship includes...• Judicious use

• Treatment protocols

• Case definitions

• Regimen• Drug

• Dose

• Route

• Duration

• Frequency

• Success/failure definitions• Post-treatment intervals

• Post-mortems• Treatment failures

• Treatment records

Stewardship includes...• Judicious use

• Treatment protocols

• Case definitions

• Regimen• Drug

• Dose

• Route

• Duration

• Frequency

• Success/failure definitions• Post-treatment intervals

• Post-mortems• Treatment failures

• Treatment records

Withdrawal time

Stewardship includes...• Judicious use

• Treatment protocols

• Case definitions

• Regimen• Drug

• Dose

• Route

•Duration• Frequency

• Success/failure definitions• Post-treatment intervals

• Post-mortems• Treatment failures

• Treatment records

Withdrawal time

Stewardship includes...• Judicious use

• Treatment protocols• Case definitions• Regimen

• Drug• Dose • Route

•Duration• Frequency

• Success/failure definitions

• Post-treatment intervals• Post-mortems

• Treatment failures• Treatment records

Withdrawal time

But stewardship starts with…

• Prevention of infectious disease• Have I taken every step possible to eliminate the need

for prevention, control, or therapy?

• Is it really needed?• Is there a disease present or imminent which requires

an antibiotic for prevention, control, or therapy?

• Is this a disease that will respond to antibiotics?

But stewardship starts with…

• Does the antibiotic I am considering have a chance?• Spectrum

• System and industry-wide monitoring of antibiotic susceptibility for key pathogens

• This assumes we have breakpoints which apply to the pathogen/disease/animal/regimen in question…

• Are other’s doing the same thing? More? Less?• Metrics

Speaking of metrics

• In my opinion, antimicrobial use monitoring should be actual use, tied to reason for use• Total kg as a metric only serves as a stick to drive “cut

the use” as a goal

• Animal Daily Doses (ADD) and Animal Regimens (AR) provide a look into drug exposure as well as number of animals receiving the regimen.

• There may be different regimens for the same drug in a species.

Antimicrobial Use Monitoring• Sales data do not drive accurate estimates of

indications for use, or even actual use

Antimicrobial Use Monitoring

• The only way to drive the needed granularity in the data is to …• Give agriculture the steering wheel for data collection

• Government audit of the sampling strategy and data handling

• Absolute guarantee of anonymity for participants

• Sampling structure must balance a view of the industry with utility for individual participants

Fundamentals

• Denominators really, really matter

• Numerators are relatively easy• And this has driven an interactive environment for this

issue in which some engage based only on numerators

Antimicrobial Use Monitoring

• Only actual use tied to reason for use will allow us to drive antimicrobial stewardship in food animals• Participants must be able to anonymously compare

themselves to peers in a private venue, and…

• investigate reasons for differences from peers

Is it as simple as…

• Label use?• See previous slides

• Could I have avoided the disease challenge?

• Is an antibiotic actually needed?

• is the disease challenge actually present or imminent?

• Is there a chance for efficacy?

• And, label use has nothing to do with magnitude of selection for resistance

Labeled use doesn’t necessarily mean…• Judicious use, or

• Compatible with stewardship, or

• The regimen most likely to minimize selection for resistant organisms

Is it as simple as…

• 100 mg in one animal = one resistance factory…. 1 mg in each of 100 animals = 100 resistance factories• Who decided that the exposure dynamics for growth

promotion (low and long) are the most likely to select for resistant organisms?

• Don’t confuse a policy decision to reduce total kg of drug with proof that this exposure is the worst exposure to select for resistant organisms

Time to wake up…

• The PK/PD parameters for efficacy don’t necessarily match with optimal exposure for minimizing the selection for resistant organisms.• Maybe the marketing guys aren’t the ones who

understand what the best PK exposure is?

• We have focused on dose comparisons for the same duration in veterinary and human medicine• Take your antibiotic for as long as your doctor

prescribes so that you don’t get a relapse with a resistant infection

Time to wake up…

•Narrow spectrum…what is “narrow spectrum”• Does a definition based on therapeutic effect

apply to avoiding selection for resistant organisms?

What is “Stewardship”?

Is there a non-antibiotic alternative which will appropriately prevent, control, or treat this disease challenge?

Selection of an antibiotic which has been demonstrated to be safe and effective for this purpose

Assuring use of the antibiotic as shown to be safe and effective

While…

Education without systems change will not work

Unthinkable

Radical

Acceptable

Sensible

Popular

Policy Prohibition of growth promotion uses of medically important antimicrobials

Prohibition of prevention and control uses of medically important antimicrobials

Prohibition of therapeutic uses of medically important antimicrobials

Rushworth Kidder told us…

• Right vs. wrong is easy, it’s right vs. right that is hard

• He outlines 4 basic components of ethical dilemmas

• Short term vs. Long Term

• Individual vs. Community

• Truth vs. Loyalty

• Justice vs. Mercy

This is Stewardship

The veterinary profession is not only going to be responsible for all medically-important antimicrobial uses in food animals…

we are going to be accountable

…from here

• The days of verbal treatment protocols are gone

• The days of unacceptable treatment records are gone

• The days of nontransparent use of antimicrobials in food animals are coming to an end

• Neither veterinarians or producers can be passive in these efforts.