Week 1: Veterinary Drug Development Use & Prescribing Flashcards
What does NADA stand for and what does it consist of
New animal drug application
Four steps of drug approval
Is the drug working? Is it safe?
What does AMDUCA stand for and what does it do?
Animal medicinal drug use clarification act
Clears use for “extra label” applications
Important given small size of animal health market
What are the four steps of drug approval?
Preliminary studies Pre clinical studies Clinical trials (FDA approval) Post approval monitoring and reporting
What does the state boards of pharmacy do?
Most relevant for us
Makes sure rules are being followed, care about cleanliness, paperwork, inventory control, involved with monitoring prescriptions and frequency
What does the FDA do?
Food and Drug Administration
regulate feed animal drugs
What does the DEA do?
Drug Enforcement Administration
Regulates controlled drugs, based on addictive potential
What does the EPA do?
Environmental protection administration
Pesticides (like flea and tick drugs)
What does the USDA do?
United States Department of Agriculture
Biologics
Regulates substances made from a living source
vaccines and serums
What does APHIS stand for?
Animal plant health inspection service
What are some places you can get information about drugs?
Manufacturer’s package inserts
Veterinary Red Book Veterinary Physicians Desk Reference
VPB Veterinary Pharmaceuticals and Biological
What is the chemical name of a drug
the molecule
What is the generic name of a drug
Common name for the molecule
What are some characteristics of the patent holders trade name?
Patents run 17 years before expiration
Exclusive marketing rights may be less than 17 years
What does Rx mean?
Prescription
What does a “C” with Roman numerals indicate about a drug?
It is a controlled substance
What is a composition statement?
Describes the physical and chemical properties of the active drug
What is clinical pharmacology?
Modes and mechanisms of actions
What is ADME stand for when dealing with pharmacokinetics?
Administration
Distribution
Metabolism and bio transformation
Excretions pathways and rates
What is LD50?
Lethal dose of 50% of patients
What is ED50?
Effective dose in 50% of patients
What do low numbers mean in a therapeutic index?
What do high numbers mean?
Low: unsafe drug
High: safer drug
How do you calculate the therapeutic index?
LD50/ED50
What is a contraindication?
Reason a drug should not be used
What are precautions?
Situations in which the drug should be used with caution
What are warnings?
Situations for known serious problems
Doesn’t make sense.. It was in the notes
What are adverse reactions or side effects?
undesirable reactions
What is dispensing?
Providing go-home or leave-behind Rx meds
What is a prescription?
An order to a pharmacist to provide a non OTC medication to a patient
What are some examples of schedule I controlled substances
Heroin LSD Marijuana Peyote Methaqualone Ecstasy
Describe schedule I controlled substances
No medical purpose , high potential for abuse
Describe schedule II controlled substances
medical purpose , high potential for abuse
What group of controlled substances needs paperwork to retrieve?
CII
What are some examples of opiate drugs in schedule CII
Hydromorphone (dilaudid) Methadone (dolophine) Meperidine (Demerol) Oxycodone (OxyContin) Oxycodone+acetaminophen (Percocet) Morphine Cocaine Opium Codeine
What are some examples of non opiates in schedule CII
Amphetamine (Dexedrine, Adderall)
Methamphetamine (desoxyn)
Methylphenidate (Ritalin)
What are some examples of CII for sedation?
Amobarbital (Amytal) (“Truth serum”)
Glutethimide (Doriden)
Pentobarbital (Nembutal)
Describe schedule CIII drugs?
medical purpose , low potential for abuse
What does “-V” mean on a drug label?
Veterinary use
Describe schedule CIV drugs?
Low potential for abuse
Describe schedule V drugs
Low potential for abuse and consist primarily of preparations containing limited quantities of certain narcotics
What should a prescriptions label show?
- Name and address of dispenser
- Clients name
- Animals name and species
- Drug name, strength, and quantity
- Date of order
- Directions for use
- Any refill information
- Warning stickers appropriate to the class of drug
Do both the ointment tubes and their containers need labels on them?
Yes
Can CVT’s refill a prescription without the approval of a vet?
Only if the drug is “refill as prn”
What are some examples of CIII drugs? (non-narcotics)
Benzphetamine (Didrex)
Ketamine (Vetalar, Ketaset,Ketaject)
What are some examples of CIV drugs?
Alprazolam (Xanax) Carisoprodol (soma) Midazolam (Versed H) Diazepam (Valium) Clonazepam (Klonopin) Triazolam (Halcion) Butorphanol (Torbugesic)
What are some examples of schedule V drugs?
Cough preparations containing <200 mg codeine/100 mL
Robitussin AC
Phenergan with codeine
