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VHMA CVPM Additional > Session 4 Law and Ethics Part 1 > Flashcards

Session 4 Law and Ethics Part 1 Flashcards

1
Q

DEA 1973

A

Main function to combat abuse of controlled substances.

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2
Q

Controlled substance act

A

Defines schedule of the drug based on likelihood of abuse

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3
Q

Handling of individual schedules of drugs are handled and enforced by

A

The DEA

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4
Q

Prescribe

A

Write a prescription to be dispensed by a pharmacy

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5
Q

Dispense

A

Includes all steps necessary to translate a rx into an individualized medication supply.

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6
Q

Administer

A

Give drug to patient according to label/instructions

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7
Q

State practice act allows non-vet staff to administer controlled drugs at the direction and under the supervision of the vet if:

A

They are agents/employees of the registered practitioner

They are performing the task in the usual course of business

They are acting under the direction of a licensed vet

They are under supervision of a licensed vet

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8
Q

Non vet staff are allowed to administer controlled drugs under which law

A

State practice acts

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9
Q

Direct supervision

A

Can mean simply that a licensed veterinarian is on premise

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10
Q

Relief veterinarians can administer controlled drugs if

A

They maintain a separate DEA registration.

This allows for compliance with the controlled substance act.

Supports contractor status to tax authorities

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11
Q

What needs to happen if there is a termination of DEA registration (registrant dies, stops practicing, no longer is licensed, etc)?

A

Notify DEA immediately

Turn in any unused drug forms

Contact DEA to determine how to best dispose of unused controlled substances left.

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12
Q

What schedule of drugs warrants a 222 form?

A

Schedule 2 drugs

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13
Q

What drug classes do not need a special form to order?

A

Schedules 3, 4, 5

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14
Q

What to do if 222 forms are missing?

A

Contact the DEA - give registrant information and serial numbers of missing forms - if numbers are not known ask how to best proceed

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15
Q

How do you use 222 forms

A

Copies 1&2 of the form are submitted to the supplier

Copy 3 of the form is retained by the registrant

Supplier retains copy 1 and sends copy 2 to the DEA

Once the drugs arrive to practice the date of receipt and qty of each drug needs to be recorded on copy 3 of the original 222 form

Must be stored separately from medical records

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16
Q

How do you lend scheduled drugs to another veterinarian?

A

For schedule 3,4,5 -
Transfer qty of drug to another registrant and obtain a receipt signed by the registered veterinarian who received the drug. Store the invoice in drug log. If receiving drugs keep the receipt showing drugs are not from a distributor.

Schedule 2 - use 222 forms

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17
Q

How do controlled drugs work in a new practice?

A

Upon acquisition an initial inventory must be taken

Practitioner transferring drugs must prepare an invoice of all drugs being delivered dated and signed by both themself and the receiver. The invoice must specify if count was done at close or beginning of day.

An exact count of scheduled 2 drugs is required

Every 2 years following the initial inventory date the registrant must take new counts and maintain those records for 2 years.

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18
Q

When can you estimate inventory counts of scheduled drugs?

A

For schedules 3,4,5 unless the container holds more than a qty of 1000.

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19
Q

How do you store controlled drugs?

A

Securely locked in a substantially constructed cabinet/safe

Drug stocks kept to a minimum

Access to storage should be restricted to only the absolute minimum amount of employees

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20
Q

Do all scheduled drugs need to be stored together?

A

No

Schedules 3,4,5 can be stored with non controlled drugs as long as still stored in a substantially constructed and securely locked cabinet.

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21
Q

What do you do if there is loss of theft of controlled drugs?

A

Registrants are required to notify the regional office of the DEA using a DEA form 106

Notify local police

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22
Q

What do you do for significant breakage or spillage of a controlled substance?

A

Use form 106 to notify the DEA.

May also want to notify local police

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23
Q

What is form 106 used for?

A

Informing DEA of Theft, loss, spillage or breakage of controlled drugs

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24
Q

Employee prohibition required - controlled drugs

A

A practice cannot employ someone who has had their DEA application revoked or denied if they will have access to controlled drugs while on duty

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25
Q

Employee responsibility to report

A

Employees are responsible to report drug diversions from any fellow employee. The info will be confidential.

Failure to report will be a determining factor in the feasibility of the employee continuing to work in a drug secure area

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26
Q

What is the DEA authorized to do without consent?

A

Enter controlled premises and conduct inspections for the purpose of copying and verifying accuracy of records, reports and other docs related to controlled substances

27
Q

What does the DEA need permission from the owner to inspect?

A

Financial, sales and pricing data

28
Q

What do DEA officials need in order to inspect?

A

ID, state their purpose, present creds, provide written notice of authority to inspect with informed consent of owner, or an administrative warrant.

29
Q

Does a DEA inspection need to be at a reasonable time and/or conducted in a reasonable manner?

A

Yeah

30
Q

When interviewing new hires can you do controlled drugs screening?

A

Yes. And be rejected by reasons described by the DEA

31
Q

Questions allowed during pre-employment screening regarding working in a controlled drugs environment

A

Within the past 5 years have you been convicted of a felony, or a misdemeanor in the last 2 years, or are you presently charged?

In the past 3 years have you ever knowingly used any narcotics, amphetamines, or barbiturates, other than those rxed to you by a physician?

32
Q

What is the CSA?

A

Controlled Substance act of 1970

Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970

33
Q

What does the CSA do?

A

Regulates persons involved in legit chain of manufacture, distribution, or dispensing of drugs.

Provides “closed system” for legit handlers of controlled drugs and reduces opportunities for controlled drugs entering the illicit drug scene

34
Q

What do state laws mean?

A

They take precedent if they are more stringent than federal.

35
Q

Schedule 1

A

Highest potential for addiction and abuse

Heroin

LSD

36
Q

Schedule 2

A

High potential for abuse and addiction

Highest accepted medicinal use

Morphine

Hydro

Fentanyl

37
Q

Schedule 3

A

Abuse leads to low/moderate addiction

Compounds with limited quantities of narcotics

Tylenol with Codeine and Nalline

38
Q

Schedule 4

A

Low potential for abuse and addiction
May lead to limited dependence

Diazepam

Tramadol

39
Q

Schedule 5

A

Lowest potential for abuse and may lead to limited dependency

Robitussin A-C

Lomotil

40
Q

Who can remove controls on a drug, bring an unscheduled drug under control, or reschedule a drug?

A

DEA and the Attorney General

41
Q

What is the CVM?

A

Center for Vet Med
With the FDA is responsible for regulating animal foods and feeds and most animal health products

42
Q

What are adulterated drugs?

A

Unsanitary components
Lack of adequate control in manufacture
Different in strength from official compendium
Mixed with another substance

2 FDA drugs mixed do not make a super FDA drug

43
Q

What are Misbranded Drugs?

A

Label is false or misleading
Does not include directions for use by lay person
Does not have the name/place of business of the manufacturer/packer/distributor, nor an accurate statement of quantity

44
Q

What are legend drugs?

A

Also prescription drugs
Used only by or under supervision of a vet
Is in the possession of a person who is regularly and lawfully engaged in the manufacture,transport, storage, or sale of a veterinary drug - or on the Rx or order of a licensed vet
Is in the possession of a licensed vet for use in lawful business

45
Q

What are the label requirements for prescription drugs

A

The statement: “Caution: Federal law restricts this drug to use by or on the order of a licensed vet.”

Recommended dose and route of administration

Quantity or proportion of each active ingredient

Names of all inactive ingredients if drug is for non oral use

Lot or control number from which it is possible to determine the complete manufacturing history of the drug

46
Q

What are the four conditions for FDA regulations to allow compounding for animal use?

A

A need to alter the approved drug to adequately medicate

Established vet-client-patient-relationship

Patient has a medical condition that needs a prescribed medication

The vet determined a compounded drug is needed

47
Q

How can vets distribute compounded drugs?

A

Compound the drug themself

Pharmacy can sell the compounded drug to the client directly via Rx

Vet canNOT purchase compounded drugs from a pharmacy to resell.

48
Q

What is the CVP

A

Compendium of Veterinary products

49
Q

Should you report an adverse reaction if you don’t think it is related to the product

A

Yes
Example: giving a dog LRS and the dog immediately vomits. The vet does not believe this to be from the LRS, but should still report it as an adverse reaction

50
Q

Is there mandatory reporting for non FDA approved products

A

No, but should still be reported to the manufacturer or distributor.

51
Q

Where to report pet food and dietary supplements adverse reactions or complaints?

A

FDA via it’s Safety Reporting Portal

52
Q

What is the USDA’s Center for Veterinary Biologics protocol for reporting?

A

An event as any undesirable occurrence after the use of an immuno biological product whether or not the event was caused by the product.

Should be reported to the manufacturer or the CVB

53
Q

Where to report pesticides and topical paraciticides

A

National Pesticide Info Center (NPIC) and the EPA

54
Q

What is the Hazzard Communication?

A

The right to know law.

All team members that may come in contact with a potentially hazardous substance need to be aware of it and how to protect themselves

55
Q

What do you need to be compliant with the Hazzard communication?

A

Designated safety officer

Annual hazard analysis inspection

Safety plans for all identified hazards

Chemical list and safety plans for immediately dangerous to life and health chemicals

Safety data sheet on all chemicals and components

Secondary labeling as needed with explanation and training on labeling system

Protocol for emergency evacuation

A training program focusing on PPE, monitoring devices and hazards of the practice

56
Q

What is a Hazzard assessment

A

Formal assessment of workplace to determine the nature of present hazards. Based on assessment practice must determine what tasks require additional protection and select appropriate PPE.

57
Q

Multi-employer Workplaces Hazzard assessment

A

All entities must make an assessment for entire area even other departments and share the SDS for each department in a central location

58
Q

What posters need to be posted

A

It’s the law poster
Notice of pending inspections until complete
Inspection citations posted for 3 days or until corrected, whichever is longer
Appropriate warning signs (exit, radiation, etc)
Written plans for preventing fire, handling hazardous chemicals, preventing injury with PPE and informing workers of dangers in the workplace.

59
Q

What are employers right in regard to OSHA

A

Set and enforce safety rules and conduct for the work place

Be present or designate rep during inspection/investigation

Require a warrant

Postpone to a reasonable time

Expect trade secrets to be confidential. Consult with an attorney before,during or after and before responding to inquiries

See any alleged complaint

Insist staff members be interviewed at a time that does not interfere with duties

Right to appeal findings

60
Q

Staff member rights re: OSHA

A

View and receive copies of all applicable OSHA standards

Access to all medical and exposure records

Be present when safety testing or monitoring is performed

Present complaints to employer and OSHA when hazard needs attention or correction

Speak with the compliance officer privately during inspection

61
Q

Will OSHA cite employees for violations of their responsibilities?

A

No. OSHA expects the employer to have a written disciplinary act the staff is aware of to enforce safety standards and rules

62
Q

What is form 300?

A

Log of work related injury and illness. This is for things beyond self first aid. These are things that would fall under workman’s comp

Running tally of all individuals with a workplace accident

63
Q

What is form 301?

A

Illness and injury incident report. Must be filled out within 7 days of a recordable work related injury

Single person incident report

64
Q

What is form 300A?

A

Summary of work related injury and illness. Must be posted from Feb 1 to April 30 of the following year. Must be recorded and displayed even if there were no injuries or illness. All forms must be kept for 5 years

VHMA CVPM Additional (10 decks)

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