phm 321 exam 1 ACTUAL UPDATED
QUESTIONS AND CORRECT ANSWERS
what is the scientific definition of a drug? what is the FDA's definition of a drug? how do
these two definitions differ? - CORRECT ANSWERS✅✅scientific: any exogenous
substance that alters the biochemistry or physiology of a living organism to produce an effect
(effect can be positive - therapeutic - or negative - toxic)
FDA: "A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease."
how can one distinguish between a drug and a food or cosmetic product? - CORRECT
ANSWERS✅✅depends on intent of manufacturer
- drug: intended for use in diagnosis, treatment, or prevention of disease and as articles to
affect the structure or function of the body
- cosmetics: intended to be rubbed, poured, sprinkled, sprayed on, introduced into or
otherwise applied to the body for cleansing, beautifying, promoting attractiveness, or altering
appearance
- both: used for both purposes
ex. capsaicin: ingredient in hot peppers, sold as topical product for pain relief
botulinum toxin: used to treat a variety of conditions (e.g. muscle spasms/spasticity,
migraine), botox used to minimize wrinkles
what are the different purposes of drug therapy? what is the most common reason for taking
OTC drugs? - CORRECT ANSWERS✅✅manage symptoms of disease, cure disease, and
prevent disease
(treat symptoms of disease or condition, eliminate or control disease causing agent, replace
loss of intrinsic substance, correct abnormality in physiology or biochemistry, disease
prevention, cosmetic and hygiene)
- treat symptoms of common diseases and conditions that aren't considered serious
what are the two main mechanisms that underlie adverse drug effects? what are some of the
most common adverse effects of OTC drugs when consumes take the product as directed?
can improper use of OTC drugs cause serious adverse effects? - CORRECT
ANSWERS✅✅- two main mechanisms: extension of therapeutic effect (too much of desired
effect - usually related to dose), "off target" effect (unrelated to therapeutic effect)
- adverse effects: GI (nausea, vomiting, diarrhea), skin rash, drowsiness, dependence
,- improper use of OTC drugs can cause effects ranging from annoying to life-threatening
what are the differences between prescription drugs and OTC drugs in terms of availability,
use, risk, regulation, etc.? - CORRECT ANSWERS✅✅prescription:
- prescribed by health care professional
- dispensed by pharmacists
- intended for use only by individual
- use associated with greater risk
- approval by FDA required (new drug application - NDA - process)
otc:
- purchased by anyone, various sources
- intended for use by multiple people
- safe and effective
- simple directions
- self-diagnosis and treatment by patient
- low abuse potential
- approval by FDA required (otc drug monographs)
what factors does the FDA consider when evaluating a drug for sale without a prescription
(OTC)? - CORRECT ANSWERS✅✅- usually approved as prescription drug first
- application by manufacturer to FDA for OTC status
- depends on: efficacy and safety, ability to self diagnose and self treat, compliance with
directions
- OTC monograph published
besides prescription and OTC drugs, what are some other common sources of drugs? -
CORRECT ANSWERS✅✅- components of foods and beverages (caffeine and alcohol)
- nicotine containing product (tobacco, e-cigarettes)
- some supplements, natural products, etc.
what are some of the most common health conditions for which consumers use OTC drugs? -
CORRECT ANSWERS✅✅pain, cold, flu symptoms, allergy symptoms, upper GI
, conditions (heartburn, acid reflux), lower GI conditions (constipation, diarrhea), minor
injuries, skin conditions
what are the variables that determine appropriate use of therapeutic drugs? how do these
variables relate to patient compliance? - CORRECT ANSWERS✅✅efficacy and safety,
ability to self diagnose and self treat, compliance with directions
compliance = generally recognized as safe and effective
how are prescription drugs regulated by the FDA? how are OTC drugs regulated by the
FDA? - CORRECT ANSWERS✅✅prescription: safety and efficacy must be demonstrated,
NDA approval process
otc: considered safe and effective, drug monograph
what is a monograph in terms of OTC drug regulation? - CORRECT ANSWERS✅✅"rule
book" listing acceptable: ingredients, indications, doses, formulations, labeling
- compliance translates into "generally recognized as safe and effective" (GRASE)
what are the required components of the label for an OTC product? how do the labels of OTC
and prescription drugs differ? - CORRECT ANSWERS✅✅- requirements of OTC labels:
active ingredient (drug), purpose/how drug works, uses (symptoms), warnings (other health
conditions or drugs, pregnancy, breastfeeding, overdose), directions for use, inactive
ingredients
- the label on prescription drugs is usually a package insert instead of on the outside of the
package on the OTC drugs
a drug sold OTC has multiple names. how many (minimum) names does a drug have, and
what are they? - CORRECT ANSWERS✅✅1. chemical name: unique to compound,
describes molecular structure
2. generic name: not capitalized, unique to compound (a few exceptions), simpler than
chemical name
3. trade or brand name: always capitalized, active ingredient can change, multiple brands
contain same drug
ex.
Acetaminophen
- chemical name: N-acetyl-para-aminophenol
QUESTIONS AND CORRECT ANSWERS
what is the scientific definition of a drug? what is the FDA's definition of a drug? how do
these two definitions differ? - CORRECT ANSWERS✅✅scientific: any exogenous
substance that alters the biochemistry or physiology of a living organism to produce an effect
(effect can be positive - therapeutic - or negative - toxic)
FDA: "A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease."
how can one distinguish between a drug and a food or cosmetic product? - CORRECT
ANSWERS✅✅depends on intent of manufacturer
- drug: intended for use in diagnosis, treatment, or prevention of disease and as articles to
affect the structure or function of the body
- cosmetics: intended to be rubbed, poured, sprinkled, sprayed on, introduced into or
otherwise applied to the body for cleansing, beautifying, promoting attractiveness, or altering
appearance
- both: used for both purposes
ex. capsaicin: ingredient in hot peppers, sold as topical product for pain relief
botulinum toxin: used to treat a variety of conditions (e.g. muscle spasms/spasticity,
migraine), botox used to minimize wrinkles
what are the different purposes of drug therapy? what is the most common reason for taking
OTC drugs? - CORRECT ANSWERS✅✅manage symptoms of disease, cure disease, and
prevent disease
(treat symptoms of disease or condition, eliminate or control disease causing agent, replace
loss of intrinsic substance, correct abnormality in physiology or biochemistry, disease
prevention, cosmetic and hygiene)
- treat symptoms of common diseases and conditions that aren't considered serious
what are the two main mechanisms that underlie adverse drug effects? what are some of the
most common adverse effects of OTC drugs when consumes take the product as directed?
can improper use of OTC drugs cause serious adverse effects? - CORRECT
ANSWERS✅✅- two main mechanisms: extension of therapeutic effect (too much of desired
effect - usually related to dose), "off target" effect (unrelated to therapeutic effect)
- adverse effects: GI (nausea, vomiting, diarrhea), skin rash, drowsiness, dependence
,- improper use of OTC drugs can cause effects ranging from annoying to life-threatening
what are the differences between prescription drugs and OTC drugs in terms of availability,
use, risk, regulation, etc.? - CORRECT ANSWERS✅✅prescription:
- prescribed by health care professional
- dispensed by pharmacists
- intended for use only by individual
- use associated with greater risk
- approval by FDA required (new drug application - NDA - process)
otc:
- purchased by anyone, various sources
- intended for use by multiple people
- safe and effective
- simple directions
- self-diagnosis and treatment by patient
- low abuse potential
- approval by FDA required (otc drug monographs)
what factors does the FDA consider when evaluating a drug for sale without a prescription
(OTC)? - CORRECT ANSWERS✅✅- usually approved as prescription drug first
- application by manufacturer to FDA for OTC status
- depends on: efficacy and safety, ability to self diagnose and self treat, compliance with
directions
- OTC monograph published
besides prescription and OTC drugs, what are some other common sources of drugs? -
CORRECT ANSWERS✅✅- components of foods and beverages (caffeine and alcohol)
- nicotine containing product (tobacco, e-cigarettes)
- some supplements, natural products, etc.
what are some of the most common health conditions for which consumers use OTC drugs? -
CORRECT ANSWERS✅✅pain, cold, flu symptoms, allergy symptoms, upper GI
, conditions (heartburn, acid reflux), lower GI conditions (constipation, diarrhea), minor
injuries, skin conditions
what are the variables that determine appropriate use of therapeutic drugs? how do these
variables relate to patient compliance? - CORRECT ANSWERS✅✅efficacy and safety,
ability to self diagnose and self treat, compliance with directions
compliance = generally recognized as safe and effective
how are prescription drugs regulated by the FDA? how are OTC drugs regulated by the
FDA? - CORRECT ANSWERS✅✅prescription: safety and efficacy must be demonstrated,
NDA approval process
otc: considered safe and effective, drug monograph
what is a monograph in terms of OTC drug regulation? - CORRECT ANSWERS✅✅"rule
book" listing acceptable: ingredients, indications, doses, formulations, labeling
- compliance translates into "generally recognized as safe and effective" (GRASE)
what are the required components of the label for an OTC product? how do the labels of OTC
and prescription drugs differ? - CORRECT ANSWERS✅✅- requirements of OTC labels:
active ingredient (drug), purpose/how drug works, uses (symptoms), warnings (other health
conditions or drugs, pregnancy, breastfeeding, overdose), directions for use, inactive
ingredients
- the label on prescription drugs is usually a package insert instead of on the outside of the
package on the OTC drugs
a drug sold OTC has multiple names. how many (minimum) names does a drug have, and
what are they? - CORRECT ANSWERS✅✅1. chemical name: unique to compound,
describes molecular structure
2. generic name: not capitalized, unique to compound (a few exceptions), simpler than
chemical name
3. trade or brand name: always capitalized, active ingredient can change, multiple brands
contain same drug
ex.
Acetaminophen
- chemical name: N-acetyl-para-aminophenol
