Extra Label Drug Use in Veterinary Behavioral Medicine

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Drugs that have been

approved by the U.S.

Food and Drug Ad-

ministration (FDA) for the treat-

ment of human psychiatric dis-

orders are increasingly being

used by veterinarians for thetreatment of animal behavior

problems. Such use, however,

is extralabel. Extralabel drug

use is the actual or intended

use of a new animal drug in a

manner that is not in accor-

dance with the drug labeling.1

Using a veterinary drug la-

beled for treatment of one vet-

erinary medical condition to

treat a different veterinary con-

dition (e.g., a behavior prob-lem) is one type of extralabel

use. Using a drug labeled for

treatment of a human condi-

tion, such as depression, to

treat an animal problem, such

as aggression, is another type

of extralabel use.

Regulatory GuidelinesExtralabel use of drugs is

common in veterinary medicine.

At referral centers, over 50%

of the prescriptions may be extra-

label.1 Until recently, veterin-

arians made extralabel drug

prescriptions under two FDA

Compliance Policy Guides

2

administered by the FDAs Cen-

ter for Veterinary Medicine.1

The Policy Guides exercised

regulatory discretion over the

Food, Drug and Cosmetic Act.

Compliance Policy Guide #7125.06

regulated extralabel use of vet-

erinary drugs in animals. Com-

pliance Policy Guide #7125.35

regulated the distribution and

veterinary use of drugs ap-

proved for use in humanmedicine. The latter guide stat-

ed that veterinary practitioners

may normally consider the use

of human-labeled drug prod-

ucts in nonfood-producing an-

imal practice without the threat

of FDA enforcement actions. In

rare circumstances (e.g., when

the health of the treated animal

is harmed), the FDA might con-

sider regulatory action or (more

likely) refer the matter to thestate veterinary licensing au-

thority for investigation.2

The regulations with regard

to extralabel drug use changed

according to the Animal Medic-

inal Drug Use Clarification Act

of 1994 (AMDUCA, Public Law

103-396). The new act, which

has been in effect since late

1996, supersedes the previous

Policy Guides and permits vet-

erinarians to prescribe (under

the guidance of the FDA) human

and animal drugs in an extrala-

bel manner for their patients.

Thus, responsible extralabel

drug use, which was previouslyregulated by Policy Guides, is

now regulated by law.3,4

The Compendium March 1997 Small Animal

establish the conditions for

the use or intended use of

the drug in animals.

At present, the details of these

regulations are under advise-ment by the FDAs Center for

Veterinary Medicine.

AMDUCA permits extralabel

use of FDA-approved human

drugs under the following con-

ditions3,5:

s The drug is used by or on

the lawful written or oral

order of a licensed veteri-narian.

s The drug is used within the

context of a veterinarian

clientpatient relationship.

s The use is in compliance

with regulations promulgat-

ed by the Secretary of Health

and Human Services and

adopted by the FDA Center

for Veterinary Medicine that

This permission to use FDA-

approved human drugs does

not mean that the veterinarian

can prescribe human psychi-

atric drugs with impunity. The

prescribing veterinarian is still

responsible for the safe use of

the drug, including adversedrug effects, and for determin-

ing that the efficacy of a drug

exceeds its risk.4,6

Safety and Efficacy DataObtaining scientific evidence

that a drug will be safe and ef-

fective is a particular problem

for veterinary behaviorists. Few

of the human psychotropic

drugs have been well studied

s The Animal Medicinal Drug Use ClarificationAct (AMDUCA) has now taken effect.

s The prescribing veterinarian is still responsiblefor the safe use of the drug, including adversedrug effects, and for determining that the effica-cy of a drug exceeds its risk.

s The establishment of a good veterinarian

clientpatient relationship is crucial for protect-ing the veterinarian against legal liability in vet-erinary behavior cases.

KEY

POINTS

Extralabel Drug Use inVeterinary Behavioral Medicine

THERAPEUTICS IN PRACTICE V

Barbara S. Simpson, PhD, DVMThe Veterinary Behavior ClinicSouthern Pines, North Carolina

Victoria L. Voith, DVM, PhDPet BehaviorDayton, Ohio


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for the treatment of behavior

problems in small animals. Be-

cause of the shortage of dou-

ble-blind, controlled studies, ar-

ticles in the veterinary literature

tend to repeat recommenda-

tions that were published in

other articlesrecommenda-

tions that often were based on

extrapolations from human for-

mularies or a few unpublished

cases. Thus, attempts to pro-

vide documented information

may tend to enhance consen-

sus based on few data.

Although the expanded inter-

est in behavior therapy has led

to increased access to infor-

mation, other sources of more

up-to-date information are rela-

tively inaccessible to the veterinar-

ian in general practice. These

Small Animal The Compendium March 1997

sources include specialty meet-

ings, specialty newsletters, or

network specialty groups (see

Sources of Information).

Minimizing Legal RiskThe uncertainty associatedwith the extralabel use of psy-

chotropic medications makes

the establishment of a good

veterinarianclientpatient

relationship crucial as protec-

tion from legal difficulties if ad-

verse effects arise.6 At the very

least, the veterinarian should do

the following:

s

Perform a complete medicaland behavioral assessment

of the patient before making

any extralabel prescription.

s Communicate well with the

client and document in the

medical record that the

client understands the risks

of the treatment.

s Be readily available to the

client if adverse reactions

arise or the treatment fails.

Documenting that the client un-

derstands the risk inherent in

any extralabel use of medica-

tion is particularly important

when human psychotropic

drugs are used in veterinary be-

havior medicine because there

has not been much clinical vet-

erinary experience with these

drugs. A signed written consent

form for the use of psychotrop-ic drugs is recommended.6,7

Veterinarians can take sever-

al steps to minimize the risk of

liability when using human psy-

chotropic medications for vet-

erinary behavior cases6 (see

Minimizing Risk of Liability). An

appropriate data base for as-

sessing the patients physical

condition should be obtained.

This may include a complete

blood count and chemistry pro-

file. Other data may be indicat-

ed for specific conditions. For

example, a urinalysis is often

indicated for urine elimination

disorders. An electrocardiogram

may be indicated when tricyclic

antidepressants are used. If rec-

ommended services are de-

clined, this should be docu-

mented in the medical record.

Aggressive AnimalsBecause of the risk of injury

to humans, the management of

aggressive animals requires

special consideration.6,8 The

veterinarian must assess whe-ther the animals owner is re-

sponsible and evaluate the risk

for serious injury. A veterinarian

treating an aggression problem

is expected to have sufficient

training and experience to make

these assessments. These

assessments are particularly

important when aggressive ani-

mals are being treated pharma-

cologically.6 If, during treat-

ment, a dog bite seriouslyinjures a person, it may be diffi-

cult to determine whether the

incident occurred because of

or despitethe medication.8

Other legal considerations

may complicate treatment. For

example, there are some theo-

retical reasons9 and some re-

ported clinical data1012 for con-

sidering the use of the selective

serotonin-reuptake inhibitor flu-

oxetine (Prozac

Dista) forthe treatment of some types of

canine aggression. However,

the widespread public miscon-

ception associating the human

use of this drug with violent be-

havior13 increases the potential

legal risk associated with pre-

scribing such treatment and

increases the necessity for

careful case selection and man-

agement.

MINIMIZING RISK OF LIABILITYIN VETERINARY BEHAVIORAL

PHARMACOTHERAPY

s Establish a good veterinarianclientpatientrelationship.

s Assess the health of the patient with a physicalexamination and appropriate screening tests.

s Assess the client for drug-abuse potential.s Know the drug being prescribed, including its side

effects, drug interactions, and the available literaturedocumenting its veterinary use.

s Discuss potential risks, including side effects andtreatment failure, with the client before therapy.

s Document the conversation by requiring the owner tosign a combined consent form and waiver.

s Recommend specific precautions to prevent humaninjury from aggressive animals.

SOURCES OF INFORMATION ONVETERINARY BEHAVIORAL MEDICINE

American Veterinary Society of Animal BehaviorDr. Laurie Martin, Secretary-Treasurer201 CedarbrookNaperville, IL 60565

Animal Behavior Consultant NewsletterDepartment of PsychologyMercer University1400 Coleman Ave.Macon, GA 31207-0001

For more information, visit the homepage of the FDAsCenter for Veterinary Medicine: http://www.cvm.fda.gov


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The Compendium March 1997 Small Animal

SummaryIn combination with tradi-

tional therapies, the extralabel

use of human psychotropic

medications offers an exciting

new option for the treatment of

animal behavior problems.

However, the veterinary practi-

tioner must be aware of current

regulations for extralabel drug

use and use good judgment in

case selection. Because of the

intricacies of selection and use

of psychotropic drugs, the vet-

erinarian should consider refer-

ring complex cases to a veteri-

nary behavior specialist.

AcknowledgmentsWe thank Dr. James F. Wil-

son and Dr. Charles Farho for

their comments.

References1. Papich MG, Davidson G: Unap-

proved use of drugs in small

animals, in Bonagura JD (ed):

Kirks Current Veterinary Thera-

py. XII. Small Animal Practice.

Philadelphia, WB Saunders Co,1995, pp 4853.

2. Food and Drug Administration:

Veterinary Drugs. Chapter 25.

Compliance Policy Guide

7125.06 and 7125.35. Rock-

ville, MD, U.S. Food and Drug

Administration, 1992.

3. Pub L No. 103-396, 340.

4. Curry-Galvin E: Extralabel rules:

The final outcome. JAVMA

210:1012, 1997.

5. Chadwell J: The extralabel drug

use law: Business as usual or

real change? Vet Prod News7:2425, 1995.

6. Wilson J: Law and Ethics of the

Veterinary Profession. Yardley,

PA, Priority Press, 1993, pp

243247.

7. Get your client to sign on the

dotted line (editorial). Vet Ec

Aug 1996.

8. Gannon DE: Clients aggressive

dogs can mean headaches for

some practitioners. Vet ProdNews:39, February 1995.

9. Yudofsky SC, Silver JM,

Schneider SE: Pharmacologic

treatment of aggression. Psy-

chiatric Ann17:397406, 1987.

10. Dodman NH, Donnelly R, Shus-

ter L, Mertens PA, et al: Fluoxe-

tine to treat dominance-related

aggression in dogs. JAVMA

209:15851587, 1996.

11. Overall KL: Animal behavior

case of the month. JAVMA

206:629632, 1995.

12. Salzman C, Wolfson AN,Schatzberg A, et al: Effect of flu-

oxetine on anger in symptomat-

ic volunteers with borderline

personality disorder. J Clin

Psychopharmacol 15:2329,

1995.

13. Thomas P: Sad attack: Prozac

and violent behavior. Harvard

Health Letter16:1, 4, 1991.

BibliographyAmerican Hospital Formulary Ser-

vice: Drug Information. Bethes-

da, MD, American Society of

Hospital Pharmacists, 1996.

American Veterinary Medical As-

sociation: Guidelines for veteri-

nary prescription drugs, in

AVMA Directory. Schaumburg,

IL, American Veterinary Medical

Association, 1997.

Drug Facts and Comparisons. St.

Louis, Wolters Kluwer Co,1996.

Physicians Desk Reference, ed 51.

Montvale, NJ, Medical Eco-

nomics, 1997.

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Extra Label Drug Use in Veterinary Behavioral Medicine