Questions From Power Points Flashcards
Abbreviations: Cp= Concentration (plasma); also Drug effect Vd= Volume of distribution Vd=dose/Cp MOA= mechanism of action MEC= minimal effective concentration Dose= potency
See front
Which of the following pharmacological data about hydrocodone will be of greatest value to my prescriber? A. Dose/frequency B. Cp plasma concentration C. Vd volume of distribution D. Major organ of elimination E. Half-life
A. Dose/freq
Matching:
- How much drug reaches target?
- How fast does drug reach target?
- What drug does for desired Cp?
- How long does drug remain at target?
A. Time to Peak
B. Volume of Distribution
C. Bioavailability
D. Half-life
- C Bioavailability
- A Time to peak
- B Volume of distribution
- D half life
The major organ of metabolism is the?
Liver
Major organ of excretion is the?
Kidney
Who controls what may be either prescribed or sold OTC?
FDA
Who decides the equivalency of brand name vs generic drug products?
FDA
Who determines who can prescribe?
The state governments and local governments (with the exception fo controlled substances, which you need a DEA DOJ license for)
Which of the following activities are regulated by the FDA?
A. Safety and efficacy of OTC meds
B. Physician’s use of a medication “off-label”
C. Efficacy of herbal meds
D. Therapeutic equivalence of generic drug formulations
A.Safety and efficacy of over-the-counter (OTC) meds
Not D because they don’t determine the therapeutic equivalence, just if it’s the same chemical compound
What three classes of drugs are limited to prescription use?
- Those limited to prescription under a New Drug Application (NDA)
- Those that are not safe without supervision of licensed practitioner (MD, NP, PA, DO)
- Habit-forming drugs (controlled substances)
Which of the following statements concerning the controlled substances act of 1970 is true?
A. Marijuana is recognized by the DEA as an approved agent for the management of PTSD
B. Prescriptions for schedule II drugs may be refilled one time in 3 months
C. Prescriptions for schedule III and IV drugs may be telephoned to a pharmacist
D. Use of schedule IV drugs has a greater potential for abuse than use of Schedule II drugs
E. Schedule V drugs can be obtained without a prescription in Colorado
(Hint, lower the schedule #, the more potential for abuse, ex: Hydrocodone= schedule I)
C. Prescriptions for schedule III and IV drugs may be telephoned to a pharmacist
A is wrong because marijuana is not recognized federally for any treatments
B is wrong because schedule II drugs cannot be refilled
D is wrong because schedule II has higher potential for abuse than IV
E is wrong because schedule V is treated like III and IV in Colorado
Schedule I-V drugs
I: high abuse potential, no medical use, not prescribed, ex: LSD, MDMA, peyote, mescaline, psilocybin, PCP
II: high abuse potential, accepted medical use, prescribed, ex: morphine, hydrocodone, methamphetamines, cocaine
III: moderate abuse potential, accepted medical use, prescribed, ex: testosterone, codeine, buprenorphine
IV: low potential for abuse, accepted medical use, prescribed, ex: tramadol, benzodiazepines
V: abuse potential even less than drugs in IV, accepted medical use, prescribed but can be OTC in some states (not Colorado), ex: codeine-antitussive, diphenoxylate-antidiarrheal
See front side
Requirements for prescribing controlled drugs:
- DEA number
- Schedule I may not be prescribed
- All II, III, IV require prescription (and V also in Colorado)
- Schedule II must be in ink in prescriber’s handwriting, CANNOT be phoned or refilled
- III, IV, and V may be phoned and refilled up to 5 Tim’s in 6 months
See front
Vicodin has been moved from a schedule III med to schedule II med. Which fo the following is a consequence of this action?
A. It now requires a written prescription in ink to be dispensed
B. It now allows the Rx to be telephoned in to the pharmacy
C. It now limits refills to 3 times in 3 months
D. It can no longer be used for tx of dental pain
A. It now requires a written Rx in ink to be dispensed (all schedule II must be in ink)
B. Is wrong because level II cannot be phone in, but III-V can be
Claims for Dietary supplements:
- Health claim:
- Structure/function claim:
- Health claim:
- Describes effect substance has on reducing risk of or preventing a disease
- requires FDA evaluation
- ex: calcium may reduce risk of osteoporosis - Structure/function claim:
- describes the role of a substance intended to maintain the structure or function of the body
- does not require preapproval by FDA
- ex: calcium may help maintain bone health
Dietary supplement structure/function claims on label must contain what disclaimer?
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Select the true statement regarding regulation of pharmacologically active chemicals in the US
A. Herbal medicines are required to undergo the same testing for safety and efficacy as prescription drugs
B. The drug must be tested in >= 10,000 patients prior to FDA approval, allowing detection of low incidence ADRs
C. Children and women of childbearing age are routinely included from phase I-III trials
D. Manufacturers of saw palmetto are allowed to claim their product will maintain healthy prostate function.
B. Is the correct answer, usually occurs in phase 4, post marketing surveillance
A is incorrect because herbs don’t have same standards as Rx pills
C is incorrect because children and women of childbearing age wouldn’t be involved in phase 1 where they see if the drug is safe
D is incorrect because dietary supplements can’t make those claims
Can the FDA regulate how a drug is actually used by a physician/dentist once it has been approved?
No, “off-label” use is permissible for non-approved indication (esp. if backed by evidence-based research)
Drug development and approval process: Phase 1: Phase 2: Phase 3: Phase 4:
Phase 1: males age 20-45, 20-100 patients, Is it safe?
Phase 2: 100-300 patients, does it work?
Phase 3: 1000-3000 patients, double blind study where neither the pt nor the experimenter know if the pt received the drug or placebo
After phase 3, New Drug Application is filed
Phase 4: post marketing surveillance
Patent expires 20 years after filing of application
Which of the following types of drug studies involve testing drug efficacy? A. phase 1 B. Phase 2 C. Phase 3 D. Phases 1 and 2 E. Phases 2 and 3 F. Phrases 1, 2, 3
E. Phases 2 and 3 are for efficacy
Phase 1 is for safety
Which of the following types of drug studies involve testing drug safety? A. Phase 1 B. Phase 2 C. Phase 3 D. Phase 1,2 E. Phase 2,3 F. Phase 1,2,3
F. Although phase 1 is specifically for safety, and 2/3 are for efficacy, all phases are for safety
Pharmaceutical equivalents: Same active ingredients Same dosage formulation (capsule, tablet, solution) Same route of admin Identical strength or concentration
Therapeutic equivalents:
Expensive and time consuming, not required by FDA for generic drugs
Assumed that bioequivalent drugs will be therapeutically equivalent
Bioequivalent drug products:
Note: product tested for bioequivalency, not drugs bioavailability
Generic drug is bioequivalent to brand if:
- Rate of drug absorption same
2. Extent (bioavailability) of drug absorption from generic formulation is within set limits of brand formulation
What types of drugs should you not switch from brand name to generic?
- Those with a narrow therapeutic index
- Those with zero order kinetics (constant amount of drug is eliminated per unit time, but the rate is independent of the concentration)
