4A Regulatory considerations for Veterinary Drug Use

FALSE

TRUE OR FALSE: the federal VCPR can be solely met through telemedicine

VCPR

This occurs when a veterinarian has assumed the responsibility for making medical judgements regarding the health of an animal and the need for medical treatment, and the client has agreed to follow the instruction of the veterinarian. PLUS the vet is there for followups and has sufficient knowledge of the animal's medical condition

a vcpr

Diagnosis, prescription of drugs, extralabel drug use, compounding, AND VFD all require WHAT

Only with an EXISTING VCPR

When can you conduct veterinary telemedicine?

1. vets can use approved animal and human drugs for extralabel as long as there is no public health threat

2. an approved human drug may be used for treatment as extralabel even when an identical approved animal drug exists

3. extralabel use of a drug approved for another species can be used if there is no approved appropriate drug labeled, or the approved drug is ineffective

4. extralabel without VCPR is illegal in all animals

Describe some of the things AMDUCA laid out for veterinarians:

ELDU

This describes the use of an approved drug in a manner that is not in accordance with the approved labeling

VFD

This outlines the process for use of medically important antimicrobials in feed when needed for specific animal health purposes the ensure judicious use of medically important antimicrobials

State boards of pharmacy

Who regulates how meds are dispensed to the public?

In the "PLAN" of the SOAP

Where do you document all medications dispensed or prescriptions written?

Cephalexin 250 mg - Give 1 capsule PO every 8 hr until gone (or for 7 days) #21 - no refills

How do you write a prescription

Opioids have limits in clinics, Schedule II-IV have limits, and if you dispense more than 7 days, you must report

What is included in the prescription monitoring program?

Schedule II narcotics

This drug has a 6 month federal time limit within which a prescription must be filled after being signed by a practicioner. There are NO refills but also no specific federal limits to quantities of drugs dispensed via a prescription

Schedule III and IV

This drug prescription may be communicated orally, in writing or electronically to the pharmacist and allows refills with limitations

The national provider identifier number

What number do veterinarians NOT have?

DEA

This agency is responsible for enforcing the controlled substances laws and regulations of the United States

DEA number

This is a unique number assigned to a healthcare provider to track controlled substances

Drug compounding

This is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual animal

1. there is no other method or route of a drug that is practical

2. safety, efficacy, and stability have been demonstrated in compounded form

3. disease conditions where you can monitor a quantifiable response to therapy

When do you compound drugs:

Federal Food, Drug, and Cosmetic Act

Which act permits compounding of animal drugs when the source of the active ingredient is a finished FDA approved drug, and not a bulk drug substance?

Bulk drug substance compounding

Which type of compounding has the FDA not approved and has not been reviewed for evidence that they are safe, effective, properly manufactured, accurately labeled, and packaged?

Bulk substance drug compounding

You can do this when FDA approved or idexed drugs are not medically appropriate to treat the animal

GFI #256

This act does not allow veterinarians to have office stock drugs to dispense from bulk drug sources due to safety concerns

a. patient is allergic to ingredient in approved product

d. the patient would required too many tablets of an approved product

e. patient cannot be safely pilled with approved capsule

Select the times where you can do drug compounding GFI #256:

a. patient is allergic to ingredient in approved product

b. compounded drug is less expensive

c. you needed the half strength of a drug

d. the patient would required too many tablets of an approved product

e. patient cannot be safely pilled with approved capsule

f. the owner preferred compounding