Session 5 Quiz

Question 1

1) When lending a controlled drug to another practitioner, what step is unnecessary for schedule III, IV and V drugs, that is necessary for schedule II drugs?
d. Using the DEA 222 form. Copy 3 of the form stays with the veterinarian who received the drug. Copy 1 stays with the registered practitioner supplying the drug. Copy 2 is sent to the DEA.
e. It is illegal to lend a schedule II drug.
f. Using the DEA 222 form, although both the receiving DVM and supplying DVM should log copies, no copy needs to be sent to the DEA.

Answer 1

Using the DEA 222 form. Copy 3 of the form stays with the veterinarian who received the drug. Copy 1 stays with the registered practitioner supplying the drug. Copy 2 is sent to the DEA.

Question 2

2) Regarding veterinarians who work at more than one location; they may administer, dispense, and prescribe controlled drugs providing they have a current DEA registration at central place of business.
c. False -May prescribe controlled drugs if they are registered at some principle place of business.
d. To administer or dispense they must be classified as an employee of a registrant, or they must register at each facility where they are employed.

Answer 2

False -May prescribe controlled drugs if they are registered at some principle place of business.

Question 3

3) Under what circumstances can a DVM dispense an adulterated drug?
a. When all ingredients are FDA/CVM approved.
b. Under no circumstances.
c. As long as there are no more than two drugs combined and both are FDA/CVM approved.

Answer 3

b. Under no circumstances.

Question 4

4) In regards to a DEA inspection, what can the inspector copy without the consent of the practice owner or representative?
a. All records and reports involving controlled drugs.
b. All records, reports, and financial information regarding controlled drugs.
c. They cannot copy any documents without consent.

Answer 4

a. All records and reports involving controlled drugs.

Question 5

5) What is the basic rationale regarding the record keeping required by the DEA for maintaining drugs received from suppliers and drugs dispensed to patients?
a. To help mitigate internal theft/abuse.
b. To complete a closed system.
c. To have a paperwork trail in the event of loss/theft.
d. To complete the DEA’s requirement for a “Trace Policy”.

Answer 5

b. To complete a closed system.

Question 6

6) The definition of Extra Label drug use is the use of any drug for other than the purpose for which it was intended.
a. True
b. False – it is the use of an APPROVED drug in a manner that isn’t in accordance with the labeling. (Example – a species not on the label). So not just any drug but a drug the FDA has already approved.

Answer 6

b. False – it is the use of an APPROVED drug in a manner that isn’t in accordance with the labeling. (Example – a species not on the label). So not just any drug but a drug the FDA has already approved.

Question 7

7) Which details below apply to a schedule V (5) drug? (multiple Choice)
a. It has no current accepted medical use.
b. It has a low potential for abuse.
c. It has a high potential for abuse.
d. It does have a current accepted medical use.

Answer 7

b. It has a low potential for abuse.
d. It does have a current accepted medical use.

Question 8

8) Generally Recognized As Safe (GRAS) substances do not have to be approved by the FDA prior to being marketed to the public. True or False?

Answer 8

a. True.

Question 9

Can a DVM administer and dispense controlled drugs if they are not registered at a principle location?

Answer 9

No, they cannot administer or dispense controlled drugs if they are not registered at a principle location but CAN PRESCRIBE controlled drugs

Question 10

Can non veterinary staff administer controlled drugs?

Answer 10

Yes if,
1. They are agents or employees of the registered practitioner
2. They are performing the task in the usual course of business
3. They are actin under the direction of a licensed veterinarian
4. They are under the direct supervision of a licensed veterinarian

Question 11

What happens if a DEA registration is terminated?

Answer 11

1. The DEA must be notified
2. Any unused forms and medications must be returned to the DEA
3. The DEA will instruct on the disposal of medication

Question 12

Are DEA-222 required to order schedule III, IV, V controlled substances?

Answer 12

No, DEA-222 forms are only required for ordering schedule I and II drugs

Question 13

What happens if blank DEA-222 forms are lost or stolen?

Answer 13

The DEA should be notified immediately and the practice should give the DEA the serial numbers for the missing forms.

Question 14

What has to be done when filling out the DEA-222 form?

Answer 14

Copies 1 & 2 are submitted to the DEA, the supplier retains copy 1, DEA retains copy 2, and the registrant retains copy 3.

Question 15

Where should Schedule II dispensing records be kept?

Answer 15

They should be kept separate from the patient medical record

Question 16

Where should Schedule III, IV, and V dispensing records be kept?

Answer 16

They may be stored in the medical record but easily accessible at all times. The common belief is they should be also kept the same way Schedule II drugs are kept.

Question 17

Can schedule III, IV, and V drugs be lent to another practitioner? If so, what is the process?

Answer 17

Schedule III, IV, and V drugs can be lent to another practitioner. Copies of the receipt of transfer must be kept by the lending practitioner and the receiving practitioner. The same process is followed when the receiving practitioner returns the drug to the lending doctor.

Question 18

Can schedule II drugs be lent to another practitioner? If so, what is the process?

Answer 18

Yes, schedule II drugs can be lent to another practitioner and a DEA 222 form must be filled out. Copy 1 must stay with the lending veterinarian, copy 2 with the DEA, and copy 3 with the receiving veterinarian.

Question 19

How should schedule II controlled substances be stored?

Answer 19

Schedule II should be stored in a locked and substantially constructed cabinet away from other non controlled drugs. Access should be kept to a minimum number of people.

Question 20

How should schedule III, IV, and V controlled substances be stored?

Answer 20

Schedule III, IV, and V substances can be stored with other non controlled substances but should still be locked in a substantially constructed cabinet.

Question 21

What should a practice do if there is theft or loss of controlled substances?

Answer 21

Registrants must contact their regional DEA office with a form 106
The police should be called if there is theft.

Question 22

Employee Prohibition Required

Answer 22

A practice cannot employ an individual who has had their DEA application revoked or denied if as a result of their employment, they will have access to controlled drugs.

Question 23

What are the employee responsibilities to report drug diversion?

Answer 23

Employees are responsible for reporting drug diversions of any fellow employees. The employer will treat all such information confidential. Failure by the employee to report drug diversions by fellow employees will be considered a determining factor in the feasibility of the employee continuing to work in a drug secure area.

Question 24

When a DEA inspector comes for an inspection, what are they allowed to do?

Answer 24

They are authorized to enter the controlled premises and inspect, copy, and verify controlled drug records and invoices. They are not allowed access to practice, financial, sales, and pricing data.

Question 25

What is the FDA (Food and Drug Administration) Center for Veterinary Medicine (CVM) responsible for?

Answer 25

regulating animal foods/feeds and most animal health products

Question 26

What are Adulterated Drugs?

Answer 26

Drugs that contain unsanitary components, lack of adequate control in manufacturing, differ in strength from official compendium, or that are mixed with another substance. Example, a practitioner takes tow or more FDA-Approved drugs and mixes them in one syringe or one bottle. In doing so the drugs have been adulterated and administering such a drug is a violation of the FD & C Act

Question 27

What is a misbranded drug?

Answer 27

Included drugs in which the labeling is false or misleading, including any drug in a package form that does not bear a label that contains the name and place of business of the manufacturer/packer/distributor, and an accurate statement on quantity. Most importantly a drug is misbranded if the label does not include adequate directions for use (defined as directions, by which, a lay person can use a drug safely and for the purpose for which it is intended

Question 28

What are the 5 requirements for a prescription drug label?

Answer 28

1. The Statement “Caution: Federal Law restricts this drug to use by or on the order of a licensed veterinarian”
2. Recommended dose and route of administration
3. Quantity or proportion of each active ingredient
4. Names of all inactive ingredients if drug is for non oral use
5. Identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug

Question 29

Define Over the Counter drugs (OTC)

Answer 29

Directions for use can be readily understood and followed by the ordinary individuals. (essential fatty acid products or joint supplements)

Question 30

Define Extra Label Use

Answer 30

The use of FDA Approved drugs in a manner other than what is approved on the label. (ie human drugs used in animals)

Question 31

Generic Drugs

Answer 31

FDA Approved, which requires a demonstration of bioequivalence of safety and efficacy with the original pioneer drug products.

Question 32

Under what 4 circumstances do most state laws and FDA regulation allow the compounding of drugs for use in animals?

Answer 32

1. The veterinarian believes there is a need to alter the approved drug to adequately medicate a non-food animal with a diagnosed medical condition
2. There is an established Veterinary Client Patient Relationship
3. The individual patient has a medical condition for which a prescribed medication is needed.
4. The veterinarian determines that compounded drug is needed for the animal

Question 33

Wholesale distribution of compounded drugs?

Answer 33

veterinarians cannot purchase compounded drugs from a pharmacy and then resell that compounded drug to a client. Veterinarians may either compound the drug themselves, or the pharmacy can sell the compounded drug directly to the client via a prescription from the veterinarian.

Question 34

What is OSHA and why was it created?

Answer 34

OSHA stands for Occupational Safety and Health Administration and was created to enact and enforce safety rules (standards) for the American workplace

Question 35

Who do OSHA standards apply to?

Answer 35

OSHA applies to all workplaces in the United States and Territories

Question 36

What does Hazard Communication (Right to know) require??

Answer 36

It requires that all team members who come into contact with potentially hazardous materials in the workplace are aware of those hazards and be instructed on how to protect themselves.

Question 37

What components of Hazard Communication do practices have to have?

Answer 37

1. A designated Safety Manager
2. An annual hazard analysis inspection
3. Safety plans in place for all identified hazards
4. A chemical list and safety plans for immediately Dangerous to Life and Health chemicals
5. Safety Data Sheets on all chemicals and components
6. Secondary labeling
7. A protocol in place for emergency evacuation
8. A training program focusing on PPE, monitoring devices, and hazards of the practice (required for 11 or more people)

Question 38

Hazard Assessment

Answer 38

Regulation requires a formal assessment of every workplace to determine the nature of the hazards that are present. Based on the assessment of the possible hazards in the workplace, the leadership of the practice must determine exactly what tasks require additional protection and select the appropriate PPE for the situation

Question 39

Multi-employer workplaces

Answer 39

All separate businesses within a shared space must create a hazard assessment for the entire area. For example: Each separate entity within the hospital will need to provide the other entity with their Safety Data Sheets or the store the safety information in a central location.

Question 40

Employer Responsibilities under OSHA’s Rights and Responsibilities

Answer 40

1. Provide a workplace, in so far as possible, free from recognized or unnecessary hazards.
2. Set and enforce safety rules in the workplace and to communicate those rules in a clear and concise manner.
3. Provide PPE and proper instruction for its use
4. Provide training and instruction for staff members to understand the hazards associated with their jobs and the steps necessary to protect themselves

Question 41

Staff Member Rights under OSHA’s Rights and Responsibilities

Answer 41

1. A workplace free from recognized hazards.
2. Be informed of their rights under the OSHA Act
3. Be informed of known hazards in the workplace and trained to safely perform their duties
4. Be provided with and instructed in the use of PPE
   5.View and receive copies of all applicable OSHA standards
5. Access to all medical and exposure records that may be maintained as part of the business
6. Be present in the workplace when safety testing or monitoring is performed
7. Present complaints to employer or OSHA when hazard or suspected hazard requires attention or correction
8. Speak with compliance officer privately during an inspection of the workplace

Question 42

Staff Member Responsibilities under OSHA’s Rights and Responsibilities

Answer 42

1. Read the OSHA poster
2. Comply with all applicable standards
3. Follow all lawful employer safety and health rules and regulations
4. Wear or use prescribed PPE while working
5. Report hazardous conditions to their supervisor
6. Report any job related injury or illness to the employer and seek treatment promptly
7. Cooperate with the OSHA Compliance Officer during an inspection or investigation

Question 43

Form 300-Log of Work Related Injuries and Illness

Answer 43

Record every work related death, or injury/illness that involves loss of consciousness restricted work activity or job transfer, days away from work, or medical treatment beyond first aid. You must also record significant work-related injuries and illnesses that are diagnosed by a physician or licensed health care professional.

Question 44

Form 301 Illness and Injury Incident Report

Answer 44

Within 7 calendar days after you receive information that a recordable work related injury or illness has occurred, you must fill out this form or equivalent.

Question 45

Form 300A-Summary of Work Related illness and Injury

Answer 45

Post this summary page from February 1-April 30 of the year following the year covered by the form. This form must be completed and displayed even if there were no recordable injuries or illnesses within the time frame