Law & Ethics - My Cards Flashcards
What is an ADULTERATED drug?
Drugs that contain unsanitary components, lack adequate manufacture controls, differ in strength from official compendium, or have been mixed with another substance.
AAFCO
Association of American Feed Control Officials
Oversees veterinary dietary supplements along with NASC, since animal dietary supplements are not FDA-approved.
ACA
2010
Affordable Care Act
Designed to expand access to health care insurance, decrease rising costs, and focus on prevention and wellness.
Accident Logs/Forms Required by OSHA & how many employees required to be enforced?
For businesses with 11 or more employees:
- Log of Work-Related Injuries and Illnesses (OSHA Form 300)
- Summary of Work-Related Injuries and Illnesses (OSHA Form 300A) - must be posted at end of year by Feb 1 and remain until April 30
- Incident & Injury Reports (OSHA Form 301) - required to be filled out within 7 calendar days of receiving notice that an incident has occurred.
Adverse Drug Event
Adverse drug event
Adverse event associated with the use of an animal drug. Also includes lack of efficacy, product defect, human exposure.
Should be reported to manufacturer first and then to FDA if desired.
Administrative Requirements Under OSHA
- Posters & Notices
- Notices of inspections (citations must be posted for 3 days or until violation is corrected, whichever is longer)
- Warning and identification signs
- Written plans (required for businesses with 10 or more employees)
AMDUCA
1994
Animal Medicinal Drug Use Clarification Act
Made ELDU legal for non food-producing animals. For food-producing animals, there are many more restrictions for ELDU.
Controlled substances - power of attorney rights
With power of attorney, vets who are agents of principal vet may order controlled substances under the registration of the principal vet.
Does not apply to prescribing.
Must still be agent of principal vet to administer/dispense.
Controlled substance losses equal to or greater than ____ must be reported to the DEA, police dept, and state board of pharmacy.
3% for the year
CSA
1970
Controlled Substance Act
Improved control over controlled substances by providing a “closed” system for legitimate handlers of these drugs. Deters illegal diversion.
Title II of the Comprehensive Drug Abuse Prevention and Control Act
DEA
1973
Drug Enforcement Administration
Enforces the CSA (Controlled Substance Act of 1970)
DEA Form 106
Used to report theft or loss of controlled drugs.
Drugs that require greater client discussion
- Anesthetics
- Psychotropics
- Chemotherapeutics
ELDU
Extra label drug use
Use of drug other than in accordance with FDA regulations
Emergency and Fire Plans should include:
- Escape procedures and route assignments
- Procedures to be followed by workers remaining to shut down or perform critical operations before they evacuate.
- Procedures to account for all employees after evacuation.
- Rescue and medical duties for those workers who are to perform them.
- Preferred means of reporting fires and other emergencies.
Employer’s Responsibilities Under OSHA
- Provide a workplace free from recognized and unnecessary hazards.
- Set, enforce, and communicate safety rules to staff members (Hospital Safety Manual)
- Provide PPE and directions for use.
- Provide training and instructions on job hazards and how to protect themselves.
Employer’s Rights Under OSHA
- Set and enforce safety rules
- Be present during an inspection/investigation
- Require a warrant before inspection
- Request inspection be postponed a reasonable time
- Expect that trade secrets will not be divulged after an inspection.
- Consult an attorney before, during, after an inspection and before responding to an inquiry
- See any complaint that’s been alleged
- Insist that staff members be interviewed at times convenient to the business
- Right to appeal findings/citations
EPA
1970
Environmental Protection Agency
Regulates topical parasiticides under FIFRA
Fair Credit Reporting Act
Federal law that regulates prescreening reports issued to employers by credit reporting agencies.
Employers must have consent of employee before any report/background check is obtained.
FDA (CVM)
Food and Drug Administration (Center for Veterinary Medicine)
Regulates prescription drugs
Regulates veterinary devices (syringes, needles, etc).
Regulation of prescription diets applies if food is considered a “drug”.
FD&C Act
Food, Drug, and Cosmetic Act
Veterinary drugs
Medicated animal feeds
Pet foods
NO grooming products
Requires drug manufacturers to establish and maintain records for ADEs. Required to report ADEs to FDA within specific timeline, depending on type of report.
FIFRA
Federal Insecticide, Fungicide, and Rodenticide Act
Controlled substances - prescriptions
CII - 30 day supply, no refills - must be written with full name and address of patient + name, address, and DEA number of practitioner.
All other classes - 30 day supply, 5 refills within 6 months - can be written or oral
Five areas of management of controlled substances
Registration
Security & protection
Record keeping
Loss reporting
Substance disposal
“Five rights” of medication administration
- Right patient
- Right drug
- Right dose
- Right route
- Right time
Fair Labor Standards Act
Regulates minimum wage, OT pay, hourly vs salary, employment of minors, and many other employment-related issues.
Enforced by Department of Labor
Applies to all employers.
For every ____workers, OSHA requires at least one toilet and one handwashing sink.
15
“General Duty Clause” in OSH Act
Employers must not allow any worker to do unnecessarily dangerous tasks.
How are controlled substances to be disposed of?
Reverse distribution
How long do you have to retain medical waste shipment records?
3 years
How long must a business keep records related to injuries/illnesses ( including OSHA forms 300, 300A, and 301)?
5 years
How long must completed I-9s be kept?
The longer of:
3 years after the date the employee begins work or
1 year after the employee’s departure
How long must controlled substance records and logs be kept?
2 years minimum after date of use
Americans with Disabilities Act
Businesses may not discriminate against a qualified person with a disability, on the basis of the disability, provided the essential components of the job can be performed. Mandates that the employer makes “reasonable accommodations” if possible, provided that the person would have been hired without the disability.
15+ employees for at least 20 weeks of the year
Ideally, how often should a controlled substance inventory be done?
Monthly
Every 2 years - required by DEA
Immigrant Reform & Control Act
1986
Made it against the law for any US business to hire illegal immigrants
Injury and Illness Prevention Plan
Aka HSM (Hospital Safety Manual)
Label Requirements for Dispensed Drugs
- Name of prescriber
- Name & address of dispenser
- Name of patient
- Date dispensed
- Name of the drug
- Unit strength of the product
- Volume or qty dispensed
- Clear directions for use
- Expiration date
Label Requirements for Rx Drugs
- “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- Recommended dosage
- ROA if not PO
- Quantity/proportion of active ingredient
- List of inactive ingredients if not PO
- Lot or control number
Which Licenses, Permits, and Registrations do vet clinics need?
- General business license (County Clerk +/- City)
- Premise permit (State Dept of Business and Professional Regulation or State Board of Vet Med Examiners)
- EIN (Federal DOL and State DES)
- DEA registration (DEA)
- Radiology & Laser Machine Registration (State Dept of Health)
Medical factors that influence the need for consent
- Age/physical condition of patient
- Likelihood of undesired side effect
- Seriousness of side effect
- Potential for fatality
- Pregnancy
NADA
New Animal Drug Approval
New animal drugs must have a NADA number, otherwise they are in violation of FD&C Act.
Name the 3 sections that many HR professionals recommend that personnel records are separated into.
- Compensation & Benefits
- Key Events
- Confidential
NASC
National Animal Supplement Council
Nonprofit industry that provides guidelines for QA, ADE reporting, and labeling standards for animal supplements.
NIOSH
National Institutes of Occupational Safety and Health
Non-DVM staff can administer CS under which 4 conditions?
- Must be employee of registered DVM
- Must perform task in the usual course of business.
- Must be under direction of licensed DVM
- Must be under direct supervision of licensed DVM.
OSHA
Occupational Safety & Health Administration
OSHA Standards Requiring Training
- General duty clause - Worker’s rights and responsibilities under the OSH Act
- Emergency and fire prevention plans
- Occupational noise exposure
- Ionizing radiation
- PPE
- Signs & tags
- Medical services and first aid
- Portable fire extinguishers
- Ethylene oxide
- Formaldehyde
- Hazard communication (chemicals)
OTC Drugs
Directions for use can be readily understood and followed by lay people.
Poison Prevention Packaging Act
1970
Rx drugs and certain non-Rx drugs be dispensed in containers with safety caps.
Requirements to ADMINISTER/DISPENSE controlled substances
Must be agent or employee of DEA registrant or be registered at facility
Requirements to PRESCRIBE controlled substances
Must have DEA registration at some principal place of business
“Right to Know” Law
AKA Hazard Chemical Standard (HCS)
Ensures workers who are exposed to chemicals are informed of the dangers of their jobs and what precautions they must take to protect themselves.
Staff Member’s Responsibilities Under OSHA
- Follow the rules of the business.
- Read the OSHA poster
- Comply with applicable standards
- Wear PPE while working.
- Report hazards to employer.
- Report any job-related illness or injury to employer and seek treatment promptly.
- Cooperate with OSHA Compliance Officer during inspection.
Staff Member’s Rights Under OSHA
- Workplace free from recognized hazards.
- Be informed of rights under OSH Act (OSHA Workplace Rights poster)
- Be informed of known hazards in the workplace and be trained to safely perform job duties.
- Be provided with PPE and instructions to properly use it.
- View and receive copies of all applicable OSHA standards.
- Access to medical and exposure records that are maintained as part of the business.
- Be present in the workplace when safety testing or monitoring is performed.
- Present complaints to employer or OSHA when hazard requires attention.
- Speak with OSHA Compliance Officer privately during inspection.
USDA
US Department of Agriculture
Regulates animal vaccines under Federal Virus, Serum, and Toxin Act of 1913
USP
1820
United States Pharmacopeia
Nongovernmental organization that sets quality standards for medicines, food ingredients, and dietary supplements.
VCPR
Veterinarian-Client-Patient Relationship
AVMA definition:
- Vet has assumed responsibility for making medical judgements re health of animal, and client has agreed to follow his/her instruction.
- Sufficient knowledge of the animal by the vet to initiate a diagnosis.
- Vet is readily available for follow-up.
Veterinary specific topics that require training
- WAG exposure
- Animal handling
- Zoonotic disease prevention
- Medical waste and sharps
- Personal safety/violence prevention
- General workplace guidelines (lifting, proper dress, reporting problems, etc)
- Handling chemo drugs
- Electrical safety
What are the 3 most probable scenarios for staff in terms of exposure to cytotoxic drugs (CDs)?
- Inhalation of dust or droplets during handling or prep
- Dermal absorption during the administration of drug, patient care, or because of a spill.
- Ingestion through contact with contaminated food or cigarettes.
What are the 3 “parts” of workplace violence by employees?
- Risk factor for violence
- Stimulus to prompt the action
- Exhibition of early warning signs
What are the 4 steps to manage compassion fatigue?
- Recognize triggers and stressors.
- Reduce triggers and stressors.
- Restore work/life balance.
- Repeat steps.
What are the 5 components of a DFW (drug free workplace) policy?
- a written DFW policy
- supervisor training
- staff education
- employee assistance
- drug testing
What are the 5 features that make a business more attractive to robbers?
- Exchange of money with the public
- Employees working alone or in small numbers.
- Late night or early morning hours
- High crime location
- On-duty employees guarding valuables
What are the 5 options for the disposal of expired or no-longer-used chemical products?
- Donate
- Recycle
- Transform
- Contain and discard
- Contract
What are the 5 requirements of a chemical safety program, according to the HCS?
- Program must be in WRITING.
- A COMPLETE LIST of all hazardous chemicals must be maintained.
- A library of SDS sheets for every chemical on this list must be maintained.
- All containers of hazardous chemicals must be PROPERLY LABELED.
- Staff must be TRAINED on the dangers and safety aspects of the chemicals.
What are the 5 types of waste generated at a vet clinic?
- Animal waste
- General waste
- Biohazardous waste
- Sharps
- Hazardous chemical waste
What are the most common reasons for violence at a business?
- Robbery or intentional assault (stalking)
- Clients under extreme duress who “lash out”
- Workers who have a dispute with supervisor or coworker.
- Unhealthy personal relationships
What are the most common RMDs (repetitive motion disorders) for vet workers?
- Trigger finger
- Raynaud’s Syndrome
- Back disorders
What are the sequential steps to solving a safety problem, according to OSHA?
- Engineering controls
- Procedural controls
- PPE
What are the three common methods of WAG scavenging?
- Active scavenging
- Passive exhaust
- Adsorpton
What are the two most common causes of fires in vet clinics?
- Overloaded, improper, or faulty wiring
- Storage of flammable materials too close to heat sources
What does the ADA require from every business, in terms of their facilities?
Every business must be accessible to the handicapped (must be able to access the facility and use its features and equipment)
What is the FMLA?
Which businesses does it apply to?
What are the eligibility requirements for employees?
Family & Medical Leave Act
Allows eligible staff members to take leave for up to a total of 12 work weeks in any 12 months for specific reasons (birth of a child, adoption/foster of a child, care of a family member with serious health issue, employee’s own serious health issue.
Businesses who employ 50 or more employees for each working day during at least 20 work weeks in the current or preceding calendar year.
- Employed for at least 12 months
- Has worked at least 1250 hours during the 12 month period preceding the start of the leave
- Works at a worksite where 50 or more employees are employed by the employer within 75 miles of that worksite
What is the most common injury of vet workers?
Animal connected accidents
What is the most effective barrier to disease transmission?
Regular handwashing
What is the most frequent injury in vet med?
Bites/scratches, followed by back injuries.
What is the preferred method of control to protect employees from adverse effects of WAGS?
Engineering controls (proper scavenging system + efficient room ventilation)
What three common chemical substances in vet med require specific safety plans to be written for each chemical?
- Formalin/formaldehyde
- Ethylene oxide
- Nitrous oxide
When does OSHA require a hearing conservation program to be put into place?
When staff are exposed to noise levels above 85 dB based on an 8 hour TWA (time weighted average).
When is it required to inform staff members of their radiation exposure measurements?
At least annually or anytime there is any exposure above 25 rems in any reporting period.
When is the most vulnerable time for an assault in vet practice?
When a staff member must go outside for something but isn’t really leaving the premises.
Where does OSHA require that the dilution, drawing up, and mixing of cytotoxic drugs occur?
In a Biological Safety Cabinet (BSC) in a special purpose room.
Which logs are required by law?
Controlled substance logs (in all states)
Surgical/anesthesia logs (in some states)
Which types of questions are prohibited from being asked in an interview?
Marriage
Age
Gender
Religion
Military status
DEA Form 222
For ordering and receiving Schedule II drugs
Copy 3 is retained by registrant
Copy 1 and 2 sent to supplier
Copy 2 sent to DEA by supplier
Procedure for lending/receving CS from another practitioner?
III, IV, and V - receipt signed by receiving registrant kept by both parties. Same procedure when drug is returned.
II - Form DEA 222
Inventory of CS at existing practice
Initial inventory must be taken
Transferor prepares dated and signed invoice for all drugs to be transferred to new owner. Must indicate if transferred at beginning or close of day.
Exact count of all Schedule II drugs.
Approx count of all other drugs, unless container has more than 1000 caps/tabs, then exact count is required.
Inventory count required every 2 years. Records must be kept at location for at least 2 years.
What is a MISBRANDED drug?
Drug whose label is false/misleading, in a package without a label that contains name and place of business of manufacturer/packer/distributor, does not have accurate statement of quantity, or does not include adequate directions for use.
COMPOUNDING OF DRUGS - Which 4 conditions must be met for a veterinarian to be allowed by the FDA to compound a drug?
- The veterinarian believes there is a need to alter the approved drug to adequately medicate a non-food animal with a diagnosed medical condition.
- Established VCPR
- The individual patient has a medical condition for which a prescribed medication is needed.
- The veterinarian determines that a compounded drug is needed for the animal.
4 branches of veterinary ethics
- Descriptive - what is right and wrong
- Official - ethics adopted by professional organizations
- Administrative - actions by government to regulate vet med
- Normative - search to determine what is right and wrong
4 types of moral problems in veterinary medicine
- Peers
- Clients
- Animals
- Society
Complete informed consent involves what elements?
*Consent must be given freely.
*Treatment and diagnosis must be given in understandable terms.
*The risks, benefits and the prognosis of the defined procedure must be stated.
*The prognosis if no treatment is selected must be stated.
*Practice must provide alternative treatments, including risks, benefits and costs.
*The client must be given an opportunity to ask questions and have them answered.
Unjust Enrichment - what considerations are there in deciding if this law applies to a situation?
1.The more valuable the animal is, the greater the chances for financial recovery.
2.The more emergent the animal’s needs are the more leeway exists to provide the emergency medical care.
3.The veterinarian attempted to reach the owner prior to medical care.
4.The extent of the emergency care required to stabilize the patient was reasonable.
Moral Distress
1.You know the ethically appropriate action to take, but you are unable to act on it.
2.You act in a manner contrary to your personal and professional values, which undermines your integrity and authenticity.
4 As to rise above moral distress
- Ask
- Affirm
- Assess
- Act
Ethics exhaustion
Fatigue, emotional distress, and the lack of will to continue to act in a way that is consistent with what you believe is the right thing to do.
3 (or 4) Elements of a Contract
- Offer
- Acceptance
- Consideration
- Intent to Contract
Promissory Estoppel
In the absence of a contract, requires the enforcement of one’s promise when another party has justifiably relied on that promise, changed its position, and incurred substantial detriment.
What 3 situations require questioning of one’s capacity to contract?
- Minority
- Mental disability
- Intoxication/substance abuse
Statute of Frauds
Situations that require written contracts in order to be enforced (as opposed to oral)
Parol Evidence
When two parties have made and signed a written contract and included in the agreement a clause stating that the writing represents the entirety of the contract, oral testimony aimed at altering or contradicting the terms of the writing will not be permitted.
Equal Employment Opportunity Commission (EEOC)
Enforces Federal laws prohibiting employment discrimination.
15+ employees who worked for the employer for at least twenty calendar weeks in the current or prior year.
Immigration Reform and Control Act
Preserves jobs for American citizens and immigrants who are authorized to work in the United States.
I-9 form
Applies to most employers (specific employee count is unclear)
Laws governing employment of minors
Must be at least 16 to work in non-farm related jobs.
For 14-15:
Need a permit
Can work 3 hours per day during school days/8 hours a day non-school.
Work cannot begin before 7am or end after 7pm or 9pm during summer break.
Civil Rights Act
Unlawful to discriminate based on individual’s race, color, religion, sex or national origin.
Pregnancy Discrimination- applies to employers with how many employees?
15+ employees
Age Discrimination - applies to employers with how many employees?
20+ employees
Applies to employees 40+ years old.
Federal Unemployment Tax Act (FUTA)
Applies to almost all employees
What is the Employee Retirement Income Security Act (ERISA)? Who enforces it?
Provides safeguards for employee interests in any employer-sponsored plan.
Enforced by Department of Labor, IRS, and Pension Benefit Guaranty Corporation
Consolidated Omnibus Budget Reconciliation Act (COBRA)- how many employees does an employer have to have?
20+ employees
Health Insurance Portability and Accountability Act (HIPAA)
Protects employees’ health-insurance coverage when they change jobs, limits exclusions for preexisting conditions, and prohibits discrimination against employees and dependents based on their health status
Mental Health Parity Act
Provides for fairness and consistency between medical and surgical benefits and mental health benefits
Employee Polygraph Protection Act
Prohibits most private-sector employers from directly or indirectly requiring an employee or prospective employee to take any lie-detector test.
Some exceptions based on type of company.
What are the required Department of Labor posters?
Fair Labor Standards Act and Minimum Wage
Equal opportunity provisions of the law
The Family and Medical Leave Act
OSHA Job Safety and Health Protection requirements
The Employee Polygraph Protection Act
The Uniformed Services Employment and Reemployment Rights Act
Right to join/form unions and associations
Who can an employee discuss client confidences or patient information with?
The client.
The client’s agent.
The treating veterinarian.
Other employees involved in the patient’s care.
