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41 Cards in this Set
- Front
- Back
Who governs the use of drugs in animals in the US?
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Center for Veterinary Medicine a subsidiary of the FDA
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What regulations deal with Rx drugs?
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The federal Food, Drug and Cosmetics Act
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What are the three main requirements of the food, drug, cosmetics act with regards to Rx drugs?
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1. Possession - lawfully able to manufacture, transport, storage or distribution of veterinary drugs
2. Sale - To vet or prescribed by vets for use in their practice 3. Statement - "Federal law restricts this drug to use by or on the order of a licensed veterinarian" |
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What are 5 important suggestions from the FDA when prescribing drugs?
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1. Read - tell owners to follow instructions
2. Sign - proper withdrawal instructions 3. First hand knowledge - refuse prescription w/o seeing patient 4. Misuse - can refuse if suspected 5. Refuse - if not following instructions |
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What are the two parts of the Animal Medicinal Drug Use Clarification Act?
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1. ELDU under certain conditions
2. Prohibition of certain drugs in food animals |
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Name the criteria for ELDU
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1. Approved drugs only
2. Valid client-patient relationship 3. Therapeutic only 4. No production use 5. No public health risk 6. No drugs prohibited by FDA |
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What constitutes ELDU/
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1. Different species
2. Different route 3. Higher dose 4. Longer duration of treatment 5. Shorter frequency 6. Different disease |
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How long do you need to keep client records?
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2 years
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What information is necessary for records?
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1. Species
2. Number of animals 3. Condition 4. Drug name and active ingredient 5. Dosage 6. Duration 7. Withdrawal, withholding, discard time |
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What information is required on the prescription label?
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1. Name and address of DVM/pharmacy
2. Name of drug 3. Specific direction 4. Cautionary statements 5. Specified withdrawal, withholding, discard times |
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What animals is phenylbutazone approved for?
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Dogs and horses
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What animals is phenylbutazone prohibited? Why?
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No food producing livestock
Induces blood dycrasias, idiosyncratic serum sickness, carcinogenic |
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What Fluoroquinolone is approved for use in cattle?
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Baytril
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What are three restrictions for Baytril use?
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1. Not approved for use in sheep, goats, deer
2. No ELDU 3. Cannot be stored in dairy farm drug cabinets |
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What is the restriction for Nitrofuran use? Why?
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No ELDU in food producing animals
Carcinogens to animals and humans |
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What are the restrictions for Clenbuterol? Why?
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Only used in horses NOT for food
Humans - tachycardia, muscle tremors, headaches, nausea, fever, chills, malaise |
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What are the restrictions for Vancomycin use? Why?
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Drugs of last resort in humans for MRSA
Increases risk of antibiotic resistance |
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What is the Grade-A Pasteurized Milk Ordinance?
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Cannot use or store unapproved or improperly labeled drugs in milk house, milking barn, stable or parlor
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What drugs are prohibited in lactating dairy cattle rations?
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Ionophores - monesin, lasalocid
DMSO Colloidal silver |
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Are Aminoglycosides banned?
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No but ELDU is discouraged - should refrain from use
18 month withdrawal time |
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What is the definition of withdrawal time?
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Time required for a drug or chemical concentration to fall below tolerance level established in a specific target animal tissue
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What is the major determining factor of withdrawal time? What are other factors?
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Therapeutic level vs. elimination
Others - drug, dose, formulation, route of administration, species, target tissue, disease, management |
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How do you determine withdrawal time (Formula you would use)?
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WDT = T1/2 x 10
takes 10 half-lives for 99.9% to be eliminated |
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Who regulates prescription medication?
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FDA
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Who monitors veterinary products?
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CVM
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Who monitors use/misuse of products which are deemed to have a high abuse schedule?
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DEA
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What information is required on a prescription? (10 things)
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1. Name, address, phone number of practioner
2. Name of patient (species) 3. Name, address of owner 4. Date written 5. Name and strength of medication 6 Quantity 7. Directions for use - amount, route, frequency 8. Refill information 9. DEA registration number if controlled substance 10. Signature of prescriber |
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Why would your patient receive a generic drug instead of a name brand?
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Because most states have interchange laws that allow generic subsitution unless you write NO substitution
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What is the purpose of the controlled substance act?
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Federal law to prevent the diversion of certain legitimate drug products
Classifies drugs into 5 categories based on abuse potential |
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What schedule describes... No accepted medical use and high abuse potential (i.e. heroin, LSA, mescaline, PCP)
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Schedule I
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What is schedule II?
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Accepted medical use w/ high abuse potential (Fentanyl, hydromorphone, oxymorphone, pentobarbital)
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What schedule is.... Accepted medical use, moderate abuse potential (Beuthanasia, thiopental, anabolic steroids, buprenorphine, ketamine)?
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Schedule III
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What is Schedule IV?
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Accepted medical use, lower abuse potential (phenobarbital, diazepam, midazolam)
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What schedule is .... Lower abuse potential but contains certain narcotics?
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Schedule V
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How are the controlled substance categories arranged?
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Schedule I have most abuse potential
Schedule V have least abuse potential |
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In Mass. what is schedule VI?
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Everything not federally controlled (antibiotics, GI products, eye products etc)
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In order to use administer and dispense controlled substances what requirements do you need to meet?
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1. Register with DEA
2. Store substances securely 3. Record amounts purchased, administered and dispensed |
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What are three regulations for Schedule II drug prescriptions?
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1. Must be a written prescription
2. Cannot have refills 3. Can only be a 30 day supply |
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What are two regulations for Schedule III, IV, V drug prescriptions?
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1. May be an oral prescription but need written prescription in 7 days
2. Can have up to 5 refills w/in 6 months of when prescription was written |
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What are four FDA requirements for compounding?
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1. Valid Veterinarian-client relationship
2. No commercially available animal or human products in correct dosage, form or concentration 3. Safe and effective 4. Prepared according to all federal and state guidelines pertaining to veterinary medicine and pharmacy practices |
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Can compounded substances be mass produced?
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No
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