Ch.35b: DEA Controlled Drugs and FL Drug Laws (Vickroy)

Question 1

how many CE hrs. required for learning about 1) dispensing legend drugs and 2) laws governing the practice of vet med

Answer 1

1) 1
2) 2
(every 2 yrs)

Question 2

over the counter drug

Answer 2

drug sold directly to consumers w/o a prescription

-assumes drug will be safe and effective when used according to label directions by a lay person

Question 3

legend drug

Answer 3

drug that can be dispensed only with a properly written order (prescription) from a licensed vet

Question 4

Rx to OTC switch requires:

Answer 4

• strong evidence for adequate safety profile

- development of labeling for safe and effective use

Question 5

3 main federal agencies that regulate animal health products and main responsibilities of each with regards to vet med

Answer 5

EPA (pesticides)
USDA (veterinary biologics - vaccines, antisera, diagnostic kits, GM organisms)
FDA (animal drugs and devices, GM organisms, pet foods)

Question 6

GM organisms contolled by which 2 agencies?

Answer 6

FDA, USDA

Question 7

What is the process for placing drugs under DEA control?

Answer 7

the inclusion of a drug on a DEA schedule or the transfer of a drug b/w schedules is overseen by the US Attorney General in consultation with the US Secretary of Health and Human services. Classification of drug depends on its potential for abuse

Question 8

DEA =

Answer 8

drug enforcement agency (branch of Dept. of Justice)

Question 9

What does DEA do?

Answer 9

ENFORCE controlled substance laws

1ary concern = limit/mitigate diversion of drugs into non-medical/illicit uses

Question 10

How does the FDA-CVM influence you?

Answer 10

• it regulates all animal drugs, vet devices and animal feeds
• establishes the dispensing status of approved drugs
• establishes regulatory controls for food animal drugs

Question 11

“Major” species

Answer 11

cattle
chicken
swine
turkeys

Question 12

VCPR =

Answer 12

veterinarian-client patient relationship (valid VCPR usually includes having seen pet w/n last 18-24 mo.)

Question 13

general requirements of vet. drug prescribing

Answer 13

1) must have valid VCPR
2) must provide written prescription if asked
3) may give Rx over the phone but must talk to licensed pharmacist for any NEW prescription*

Question 14

can you call/fax prescriptions for schedule II drugs?**

Answer 14

NO

Question 15

controlled drug

Answer 15

drug product that can be purchased, prescribed, or dispensed only by individuals who have or are working under a valid license from the DEA

• have abuse potential
• may be addictive

Question 16

decisions to change a drug’s class is made by

Answer 16

Attorney General

Question 17

Name 4 class II drugs***

Answer 17

(opiates)
morphine
fentanyl
pentobarbital
dexedrine

Question 18

Name 2 Class III drugs

Answer 18

ketamine

buprenorphine

Question 19

T/F: Class I drugs have NO approved medical uses

Answer 19

T

Question 20

what do you have to do to prescribe, administer or dispense controlled substances?

Answer 20

register with and be licensed by DEA

Question 21

veterinarians that act as “agents” of a DEA license holder are allowed to:

Answer 21

administer or dispense controlled drugs, but NOT prescribe or purchase them

Question 22

How do you order Schedule III, IV, and V agents?

Answer 22

provide copy of current DEA number to supplier (not pharmacy)

Question 23

How do you order Schedule II agents?

Answer 23

only via a Federal Triplicate DEA Form 222

Question 24

rules regarding prescribing class II agent

Answer 24

• must be for a SPECIFIC patient
• can’t be refilled
• multiple CII drugs can be on a single script
• can’t be filled prior to written date

Question 25

security and storage recommendations

Answer 25

• maintain stocks to a practical minimum
• limit access
• use lock-box

Question 26

How should CII records be kept?

Answer 26

SEPARATE from all others (including purchase, use, dispense, inventory,etc.)

Question 27

How do controlled substance transfers work?

Answer 27

you CAN transfer limited amt. of controlled substance to/from another DEA registered practitioner
-must not exceed 5% of the total # of dosage units used/dispensed/prescribed**

Question 28

loss or theft of records:

Answer 28

must be reported to DEA. Drugs should be recorded on both patient’s medical record and readily retrievable log or controlled substance record.

Question 29

more Americans currently abuse prescription drugs than the number of those using cocaine, hallucinogens, and heroin combined

Answer 29

:)