OTC/Herbal Supplements (EXAM V) Flashcards
Prescription Drugs (Rx) vs Non-Prescription Drugs (OTC)
Rx is only available with a prescription view “more effective” by the public.
Rx misuse has higher potential for harm.
Rx regulated by FDA.
OTC is freely available to general public.
OTC is GRASE (Generally Recognized As Safe & Effective)
What is BTC?
Behind the counter.
Class requiring pharmacist consult (pseudoephedrine, insulin)
What drug was induced in the 1950s for morning sickness that caused tetratogenic effects on pregnant mothers?
What is it currently useful for?
Thalidomide
Currently useful for multiple myeloma.
What are the phases of clinical testing?
Investigation New Drug (IND) is filed with the FDA.
Phase 1 (20-100 healthy volunteers)
-Dosing, Safety, ADME
Phase 2 (100-200 patients)
-Double-blind, efficacy
Phase 3 (1000s patient)
-Market formulation, route
New Drug Application (NDA) 1-2 year for approval
Dietary supplements are controlled as __________.
What does this mean for regulation?
Food
Eliminates the need for proof of efficacy. FDA must prove the item is not safe.
What are the effects of Echinacea
Echinacea (E-ke-a-sha)- Stimulate immune system, anti-inflammatory
What herbal supplements will you take for memory, immune, analgesia?
Ginseng
What herbal supplement will you take for reduction in hepatotoxicity?
Milk Thistle
What herbal supplement will you take for BPH?
Saw Palmetto
What herbal supplement will you take anxiety, muscle relaxant, sedative?
Kava Kava
What herbal supplement will you take for BP, CA, GI Health?
Kombucha tea- yeast and bacteria
What herbal supplement will you take as a laxative and used for burns?
Aloe
What herbal supplement will you take for menstrual discomfort?
Black cohosh
What does GRASE stand for?
Generally Recognized As Safe & Effective
What are the effects of Garlic?
Garlic- HMG CoA Reductase Inhibitor- reduce cholesterol
