Exam 1 - Drug Formulations & Regulations: Lecture & Professional Skills

Question 1

what is pharmacodynamics?

Answer 1

body’s biological response to drugs

‘what the drug does to the body’

Question 2

what is pharmaceutics?

Answer 2

dosage form design

Question 3

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

Answer 3

e. all of the above

Question 4

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

Answer 4

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

Question 5

what does sterility entail? what is included in it? what is not included?

Answer 5

‘free from bacteria or other living microorganisms, totally clean’

injections, fluids, ophthalmics

not oral meds or otics!!

Question 6

what is stability? what is included in it?

Answer 6

‘not likely to change or fail, firmly established’

reconstitution, compounds, degradation

Question 7

how long are fluid bags considered to be stable?

Answer 7

24-48 hours

Question 8

T/F: there are no true studies for sterility

Answer 8

true

Question 9

what does MDV mean?

Answer 9

**

Question 10

what book can you find information on stability of a drug?

Answer 10

handbook of injectable drugs - trissel

Question 11

what is pharmacokinetics?

Answer 11

movement of drugs within the body - how the drug is working

‘what the body does to the drug’

Question 12

what does pharmacokinetics help decide?

Answer 12

therapeutic dose range - important to consider in food animals & antibiotic therapy

Question 13

T/F: an extended release medication can be cut in half

Answer 13

false - coating on the tablet is what makes it extended release

Question 14

T/F: an extended release medication can be cut in half only if it’s scored

Answer 14

true

Question 15

T/F: an extended release medication should be given at the same dose less often

Answer 15

false - most extended release medications should be given at a larger dose less often

Question 16

T/F: if medication should be taken with food, it’s always to prevent gi upset

Answer 16

false - food changes the bioavailability of many medications

Question 17

what is the major difference between commercial & compounded products?

Answer 17

compounded products have no approval process & everyone compounds differently

commercial products have to go through the FDA approval process

Question 18

what must be met to become an FDA approved product?

Answer 18

pure, safe, efficacious, entire label is approved, human food safety, environmental impact - hazards to personnel, & consistently reproducible batch to batch

Question 19

T/F: the FDA is responsible for taking action against adulterated or misbranded products after it reaches the market

Answer 19

true

Question 20

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

Answer 20

true

Question 21

what are nutriceuticals?

Answer 21

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

Question 22

what are the laws in texas for compounding medicine in veterinary medicine?

Answer 22

1. compound only for a specific animal or herd with an established VCPR
2. compound only to treat a disease or condition which threatens the animal’s health or causes suffering or death if left untreated
3. don’t compound or order a compound if an FDA approved drug will appropriately treat the animal
4. 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
5. only compound or order a compound if an FDA approved product is the active ingredient
6. don’t compound products similar to FDA approved products
7. ensure safety & efficacy - use a pharmacist when necessary
8. food animal - add withdrawal time, no food residue, use animal drugs first, & identify animal that received the treatment
9. don’t use fanciful names or additives
10. don’t promote or resell compounds
11. don’t sell to other people - vets, pharmacists, etc

Question 23

what are some examples of when compounding is necessary?

Answer 23

dose is too small or large, backorders, no available in USA, d/c meds, meds that don’t exist, toxic ingredients, & food allergies

Question 24

what are the 3 compounding recommendations from the AVMA?

Answer 24

1. nothing else will appropriately treat
2. know the safety & stability of the compound in the species you are treating
3. clinically monitor the patient to determine if the compound is working

Question 25

what factors are involved when treating a patient?

Answer 25

age, breed, weight, & guidelines