Exam 1 - Drug Formulations & Regulations: Lecture & Professional Skills Flashcards
what is pharmacodynamics?
body’s biological response to drugs
‘what the drug does to the body’
what is pharmaceutics?
dosage form design
which medication can safely be used as stated below?
a. an injection can be given in the eye
b. an ophthalmic can be given in the eye
c.
an oral medication can be crushed & put into a wound
d. an injection can be given by mouth
e. all of the above
e. all of the above
for the following drugs, list the other ways they can safely be given:
a. nitenpyram (capstar) tablet
b. diazepam injection
c. voriconazole injection
d. gentamicin sterile solution
e. midazolam injection
f. buprenorphine injectable
a. nitenpyram (capstar) tablet - rectally administered
b. diazepam injection - rectally administered
c. voriconazole injection - entitled in the eye
d. gentamicin sterile solution - injected (not FDA approved for injection, FDA approved for intrauterine flush)
e. midazolam injection - given nasally
f. buprenorphine injectable - given orally
what does sterility entail? what is included in it? what is not included?
‘free from bacteria or other living microorganisms, totally clean’
injections, fluids, ophthalmics
not oral meds or otics!!
what is stability? what is included in it?
‘not likely to change or fail, firmly established’
reconstitution, compounds, degradation
how long are fluid bags considered to be stable?
24-48 hours
T/F: there are no true studies for sterility
true
what does MDV mean?
**
what book can you find information on stability of a drug?
handbook of injectable drugs - trissel
what is pharmacokinetics?
movement of drugs within the body - how the drug is working
‘what the body does to the drug’
what does pharmacokinetics help decide?
therapeutic dose range - important to consider in food animals & antibiotic therapy
T/F: an extended release medication can be cut in half
false - coating on the tablet is what makes it extended release
T/F: an extended release medication can be cut in half only if it’s scored
true
T/F: an extended release medication should be given at the same dose less often
false - most extended release medications should be given at a larger dose less often
T/F: if medication should be taken with food, it’s always to prevent gi upset
false - food changes the bioavailability of many medications
what is the major difference between commercial & compounded products?
compounded products have no approval process & everyone compounds differently
commercial products have to go through the FDA approval process
what must be met to become an FDA approved product?
pure, safe, efficacious, entire label is approved, human food safety, environmental impact - hazards to personnel, & consistently reproducible batch to batch
T/F: the FDA is responsible for taking action against adulterated or misbranded products after it reaches the market
true
T/F: manufacturers & distributors are prohibited from marketing products that are adulterated or misbranded, & are responsible for evaluating the safety & labeling of their products prior to market to ensure all DSHEA & FDA requirements are met
true
what are nutriceuticals?
any substance that is a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease - don’t have to be what they say they are
what are the laws in texas for compounding medicine in veterinary medicine?
- compound only for a specific animal or herd with an established VCPR
- compound only to treat a disease or condition which threatens the animal’s health or causes suffering or death if left untreated
- don’t compound or order a compound if an FDA approved drug will appropriately treat the animal
- labeling requirements - date compounded, name & strength of ingredients, identity of animal, withdrawal times, condition to be treated, dispensed date, & expiration date not to exceed the length of prescribed treatment
- only compound or order a compound if an FDA approved product is the active ingredient
- don’t compound products similar to FDA approved products
- ensure safety & efficacy - use a pharmacist when necessary
- food animal - add withdrawal time, no food residue, use animal drugs first, & identify animal that received the treatment
- don’t use fanciful names or additives
- don’t promote or resell compounds
- don’t sell to other people - vets, pharmacists, etc
what are some examples of when compounding is necessary?
dose is too small or large, backorders, no available in USA, d/c meds, meds that don’t exist, toxic ingredients, & food allergies
what are the 3 compounding recommendations from the AVMA?
- nothing else will appropriately treat
- know the safety & stability of the compound in the species you are treating
- clinically monitor the patient to determine if the compound is working
what factors are involved when treating a patient?
age, breed, weight, & guidelines
