Session 4 Law and Ethics Part 1 Flashcards
DEA 1973 function
Main function to combat abuse of controlled substances.
Controlled substance act
Defines schedule of the drug based on likelihood of abuse
Handling of individual schedules of drugs are handled and enforced by
The DEA
Prescribe
Write a prescription to be dispensed by a pharmacy
Dispense
Includes all steps necessary to translate a rx into an individualized medication supply.
Administer
Give drug to patient according to label/instructions
State practice act allows non-vet staff to administer controlled drugs at the direction and under the supervision of the vet if:
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
Non vet staff are allowed to administer controlled drugs under which law
State practice acts
Direct supervision
Can mean simply that a licensed veterinarian is on premise
Relief veterinarians can administer controlled drugs if
They maintain a separate DEA registration.
This allows for compliance with the controlled substance act.
Supports contractor status to tax authorities
What needs to happen if there is a termination of DEA registration (registrant dies, stops practicing, no longer is licensed, etc)?
Notify DEA immediately
Turn in any unused drug forms
Contact DEA to determine how to best dispose of unused controlled substances left.
What schedule of drugs warrants a 222 form?
Schedule 2 drugs
What drug classes do not need a special form to order?
Schedules 3, 4, 5
What to do if 222 forms are missing?
Contact the DEA - give registrant information and serial numbers of missing forms - if numbers are not known ask how to best proceed
How do you use 222 forms
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
How do you lend scheduled drugs to another veterinarian?
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
How do controlled drugs work in a new practice?
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.
When can you estimate inventory counts of scheduled drugs?
For schedules 3,4,5 unless the container holds more than a qty of 1000.
How do you store controlled drugs?
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
Do all scheduled drugs need to be stored together?
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.
What do you do if there is loss of theft of controlled drugs?
Registrants are required to notify the regional office of the DEA using a DEA form 106
Notify local police
What do you do for significant breakage or spillage of a controlled substance?
Use form 106 to notify the DEA.
May also want to notify local police
What is form 106 used for?
Informing DEA of Theft, loss, spillage or breakage of controlled drugs
Employee prohibition required - controlled drugs
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
Employee responsibility to report
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
What is the DEA authorized to do without consent?
Enter controlled premises and conduct inspections for the purpose of copying and verifying accuracy of records, reports and other docs related to controlled substances
What does the DEA need permission from the owner to inspect?
Financial, sales and pricing data
What do DEA officials need in order to inspect?
ID, state their purpose, present creds, provide written notice of authority to inspect with informed consent of owner, or an administrative warrant.
Does a DEA inspection need to be at a reasonable time and/or conducted in a reasonable manner?
Yeah
When interviewing new hires can you do controlled drugs screening?
Yes. And be rejected by reasons described by the DEA
Questions allowed during pre-employment screening regarding working in a controlled drugs environment
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?
What is the CSA?
Controlled Substance act of 1970
Title 2 of the Comprehensive Drug Abuse Prevention and Control Act of 1970
What does the CSA do?
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
What do state laws mean?
They take precedent if they are more stringent than federal.
Schedule 1
Highest potential for addiction and abuse
Heroin
LSD
Schedule 2
High potential for abuse and addiction
Highest accepted medicinal use
Morphine
Hydro
Fentanyl
Schedule 3
Abuse leads to low/moderate addiction
Compounds with limited quantities of narcotics
Tylenol with Codeine and Nalline
Schedule 4
Low potential for abuse and addiction
May lead to limited dependence
Diazepam
Tramadol
Schedule 5
Lowest potential for abuse and may lead to limited dependency
Robitussin A-C
Lomotil
Who can remove controls on a drug, bring an unscheduled drug under control, or reschedule a drug?
DEA and the Attorney General
What is the CVM?
Center for Vet Med
With the FDA is responsible for regulating animal foods and feeds and most animal health products
What are adulterated drugs?
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
What are Misbranded Drugs?
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
What are legend drugs?
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
What are the label requirements for prescription drugs
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
What are the four conditions for FDA regulations to allow compounding for animal use?
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
How can vets distribute compounded drugs?
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.
What is the CVP
Compendium of Veterinary products
Should you report an adverse reaction if you don’t think it is related to the product
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
Is there mandatory reporting for non FDA approved products
No, but should still be reported to the manufacturer or distributor.
Where to report pet food and dietary supplements adverse reactions or complaints?
FDA via it’s Safety Reporting Portal
What is the USDA’s Center for Veterinary Biologics protocol for reporting?
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
Where to report pesticides and topical paraciticides
National Pesticide Info Center (NPIC) and the EPA
What is the Hazzard Communication?
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
What do you need to be compliant with the Hazzard communication? 8 things
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
What is a Hazzard assessment
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.
Multi-employer Workplaces Hazzard assessment
All entities must make an assessment for entire area even other departments and share the SDS for each department in a central location
What posters need to be posted (5)
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.
What are employers right in regard to OSHA -8
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
Staff member rights re: OSHA
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
Will OSHA cite employees for violations of their responsibilities?
No. OSHA expects the employer to have a written disciplinary act the staff is aware of to enforce safety standards and rules
What is form 300?
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
What is form 301?
Illness and injury incident report. Must be filled out within 7 days of a recordable work related injury
Single person incident report
What is form 300A?
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
