Rx Writing & Drug Eval

Question 1

Describe the role of federal, state, and local governments in regulating the prescription writing process

Answer 1

Feds decide WHAT can be prescribed
- FDA says what’s safe and categorizes.
State decides WHO can prescribe (exception: controlled substances governed by DEA)
Local gov makes laws specific to jurisdiction (ex. MMJ)

Question 2

Summarize the preclinical and clinical phases (1-4) of the new drug approval process of the FDA with respect to types of subjects, number of subjects, approximate time involved, and limitations in pronouncing a new drug as “safe”

Answer 2

Pre-clinical: 5-8 years. Find a lead compound (chem synth or bio product) then test in animals. Determine safe dosage range in humans, file NDA for specific use
Phase I: IS IT SAFE, pharmoacokinetics? 2-10 years. Use NORMAL volunteers (usually

Question 3

Compare and contrast FDA regulation of prescription drugs vs dietary supplements (DSHEA 1994).

Answer 3

Supplements are not required to be reviewed by the FDA for safety before they are marketed (presumed to be safe based on their history of use by humans)
Manufacturer must provide reasonable evidence that the product is safe for human use BUT DOES NOT have to provide the FDA with evidence that the product is safe and effective
HOWEVER, the burden of proof is entirely on the FDA to show that the product is not safe before it can restrict its use or remove it from the market.
BOTTOM LINE: FDA has minimal regulatory control over its sale and distribution.

Question 4

Distinguish health claim vs. structure/function claim

Answer 4

Health claim: effects on reducing the risk of or preventing a disease, e.g., “calcium may reduce the risk of osteoporosis.” REQUIRES FDA evaluation and authorization
Structure/function: role in maintaining the structure or function of the body, e.g., calcium may help maintain bone health”. DO NOT require preapproval by FDA.
Health claims must be accompanied by: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Question 5

Distinguish the different categories of drug equivalency (pharmaceutical, biologic, and therapeutic) and the relevance to generic vs brand name products.

Answer 5

Pharmaceutical: Identical in every way (ingredient, dosage, form, ROA, strength)
Bio: pharm equivalent w/ same bioavailability (same amount in blood - suff. for FDA)
Therapeutic: Pharm equivalent that, when administered to the same individual in the same dosage regimen, provide the same efficacy and safety (NOT required to prove, bio equiv assumed to be thera equiv)
Generic is identical in every way! Exception: levothyroxine & anti-epileptic. Cheaper b/c no cost of development & marketing. In some states pharmacist can sub, but overall prescriber has ultimate control

Question 6

1 grain = ___ mg

Answer 6

60 or 65mg (technically 64.8)

Consequently 1 gram = 1,000mg = (1,000/65) grains = 15.4 grains

Question 7

1 ounce = __ g

Answer 7

30g (technically 28.35)

So 1lb = 16 ounces = 16 * 28 g = 454g

Question 8

1 kg = __ lbs

Answer 8

2.2

Question 9

1 drop = ___ mL

Answer 9

0.05 mL

So, 1 mL = 20 drops

Question 10

1 tsp = ___ mL

Answer 10

5 mL

Question 11

1 tbsp = __ mL

Answer 11

15 mL

Question 12

1 fl oz = __ mL

Answer 12

30 mL (technically 29.56mL)

Question 13

Latin abbrev. for timing

Answer 13

qod = every other day
qd = every day
bid, tid, qid, = 2x, 3x, 4x daily
qam = every morning
hs = at bedtime
ac / pc = before/after meals
prn = when needed

Question 14

Latin abbrev for ROA

Answer 14

ad, as/al, au = right ear, left ear, both ears
od, os/ol, ou = right eye, left eye, both eyes
IA, IM, IV, IVPB = Intra art, musc, vein, vein + piggyback
po, pr = by mouth, by rectum
sc/sq = subcutaneous
vag = vag - ha!

Question 15

Distinctions between prescription drugs and controlled substances

Answer 15

Compared to normal rx drugs, CS have abuse potential, divided into 5 cats for
Medical usefulness
Abuse potential
Dependence (degree to which they may lead to physical / psychological dependence if they are abused)

Question 16

Explain the special requirements for prescribing controlled substances and their schedules I-V

Answer 16

All rx require DEA #
Schedule I drugs may not be prescribed.
Schedule II prescriptions must be in ink in prescriber’s handwriting; CANNOT PHONE IN
III, IV, (+V in CO) may be phoned in but more than 5x in 6 months

Question 17

Explain how prescribing controlled substances in Colorado differs from other states

Answer 17

Feds say Schedule V doesn’t need rx; they’re OTC (sometimes behind pharm counter, still no rx). In CO: V is treated like III, IV so you need a rx.

Question 18

Suggestions for improved prescription writing

Answer 18

Mostly common sense:
Seek pharmacist advice if unsure
Write legibly
Use metric system
Always lead, never trail with 0
Avoid abbrv.
Beware of lookalikes (Celebrex vs. Cerebryx)