Clin Pharm Exam I - Learning Objectives Flashcards
(46 cards)
What is the FDA responsible for in terms of drugs?
What types of medications does this NOT cover?
- Drug safety in animals, people, the environment, and the food supply
- Safety and efficacy (the product will consistently and uniformly perform as the label claims it will
DOES NOT COVER
- Neutraceuticals, compounded drugs, or FDA-approved drugs used extra-label
What government agency is responsible for regulating veterinary drug use?
FDA
Where do you report an adverse drug interaction?
FDA website
What is the definition of prescription drugs?
They can only be dispensed by a licensed DVM or on the written order of one.
Must be labeled with “Federal law restricts these drugs to use by or on the order of a licensed veterinarian”
What are the components of the veterinary-patient-client-relationship (VPCR)?
- Responsible for clinical judgement about the health of patient and need for treatment
- Client agrees to follow your directions
- You have knowledge about the patient (recently had a PE, personally acquainted with the care and keep of patient)
- Available for follow ups
What is the minimum information required to be a on the label of a dispensed veterinary drug?
- Name/address of dispenser
- Date of order/when filled
- Name/address of veterinarian who prescribed the drug
- Directions for use
- Any necessary warning/precautionary statements including withdrawal times
Under AMDUCA, what does the FDA have the right to prohibit in food animals?
Extra-label drug use of certain drugs
What drugs are specifically prohibited for use in food animals?
1) Chloramphenicol
2) Clenbuterol
3) Diethylstilbestrol (DES)
4) Dimetridazole/nitromidazoles
5) Furazolidine/nitrofurazone
6) ELDU of fluoroquinolones
7) Glycopeptides
8) Sulfonamide drugs (lactating dairy cattle)
9) Phenylbutazone (Female dairy cattle >20 mo)
10) Cephalosporins
11) Adamantane/neurimidase inhibitors (ELDU in poultry)
What is the definition of extra-label drug use?
Actual or intedned use of a drug in an animal in a manner that is not in accordance with the FDA approved labeling
- Use in different species
- Different dosage
- Frequency
- Route of administration
- Deviation from labeled withdrawal time
When is extra-label drug use (ELDU) permitted by the FDA?
- Within the scope of a VCPR
- When health of animal is threatened, or suffering/death may result from non-treatment
- No animal drug approved for use
- Animal drug is approved, but doesn’t have needed active ingredient, not required dosage/concentration, or is clinically ineffective when used as labeled
What are the absolute requirements for ELDU in food animals?
- Diagnose and evaluate the condition for which you are prescribing
- Ensure client maintains ID of treated animals
- Establish an extended withdrawal time
- Ensure no illegal drug residues will occur
- Have thorough record keeping
- ELDU can never be used for enhanced production
What is the definition of a compounded drug?
- Any manipulation of an FDA approved drug
- Drug formulated from bulk chemical that is not approved by the FDA
Includes
- Mixing formulation
- Crushing/breaking tablets
- Adding flavoring to a commercially available oral solution
- Not following label indications for prep of formulation, using different dilution factor/diluent, mixing different drug proportions
When does the FDA allow the use of compounded drugs?
- Valid VCPR
- Health of animal is threatened or suffering
- No FDA commercial animal or human drug available
- Product is made from an FDA approved human or animal drug
- Compounded drug must be safe and effective
- Amount of product is made on an individual basis
- Food animals MUST be provided with an extended withdrawal time
What are the advantages of compounded drugs?
- Discontinued FDA approved formulation
- Patient is allergic to agents in FDA approved products
- Tailored dosage strengths
- Palatability/dosage form changes
- Drug shortages
What are some disadvantages of compounded drugs?
- No monitoring of manufacturing process
- No inspected facilities
- Drug stability is unknown
- No assessment of purity or potency
What are some possible consequences on drug effect that are inherent with compounded drugs?
- Suboptimal effect
- Toxicity
- Time of onset
- Intensity/duration
- Residue elimination/withdrawal time
How do you recognize if a drug is FDA approved?
NADA number listed on label
What is a controlled substance?
A prescription drug that is placed into a schedule based on:
- Current accepted medical use
- Relative abuse potential
- Liklihood of causing dependence when abused
What qualifies a Schedule I drug?
Give examples.
- No currently accepted medical use in the US
- Lack of accepted safety for use
- High potential for abuse
Heroin, LSD
What qualifies a Schedule II drug?
Give examples.
- High potential for abuse
- Severe psychological or physical dependence
Hydromorphone, methadone, fentanyl
What qualifies a Schedule III drug?
Give examples.
- Potential for abuse less than II
- Abuse may lead to moderate or low physical dependence, OR high psychological dependence
Buprenorphine, products with less than 90 mg of codeine
What qualifies a schedule V drug?
Give examples.
- Low potential for abuse
Alprazolam, diazepam, lorazepam, midazolam
What qualifies a Schedule V drug?
Give examples.
- Very low potential for abuse
Preparations with limited quantities of certain narcotics
- Cough medications with no more than 200 mg codeine per 100 ml/G - Robitussin AC, ezogabine
What are special considerations with controlled substances?
- Requirements for schedules can change
- Registration with DEA and state BOP
- Thorough recordkeeping
- Special Ordering requirements
- Special prescribing requirements
- Special security measures
