mid term

Question 0

Federal Food, Drug, and Cosmetic Act (FD&C)

Answer 0

•Authorized the FDA to demand evidence ofsafety for new drugs, issue standards for food, and conduct factory inspections

Question 1

Pure Food and Drug Act

Answer 1

•First attempt to protect consumers

• minimal standards of strength, purity, and quality
• dangerous ingredients

Question 2

FD&C Durham-Humphrey Amendment

Answer 2

Defined drugs that could only be purchased if thepatient had a prescription from a licensed practitioner

Question 3

FD&C Food Additives Amendment

Answer 3

Approval of new food additives was required & safety determined

Question 4

FD&C Color Additives Amendment

Answer 4

All colors (natural or synthetic) must be approved

Question 5

FD&C Kefauver-Harris Amendment

Answer 5

• Required drug manufacturers to use standard
labeling, listing adverse reactions and
contraindications
• Also required drug companies to prove their drugs’safety and effectiveness

Question 6

Comprehensive Drug AbusePrevent and Control Act

Answer 6

• Commonly referred to as Controlled
Substances Act
• Designed to regulate the dispensing of drugs that have the potential for abuse (controlled substances)

Question 7

schedule I

Answer 7

drugs with no currently accepted medical use and a high potential for abuse

Question 8

schedule II

Answer 8

drugs with a high potential for abuse, less abuse potential than Schedule I drugs, accepted medical treatment

Question 9

schedule III

Answer 9

drugs with a moderate potential for physical and psychological dependence, acceptable for medical use

Question 10

schedule IV

Answer 10

drugs with a low potential for abuse and low risk of dependence, accepted for medical use

Question 11

schedule V

Answer 11

drugs with a limited potential for abuse and low risk of dependence, accepted for medical use

Question 12

schedule I drugs

Answer 12

heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote

Question 13

schedule II drugs

Answer 13

cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin

Question 14

schedule III drugs

Answer 14

Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone

Question 15

schedule IV drugs

Answer 15

Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien

Question 16

schedule V drugs

Answer 16

cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin

Question 17

Dietary Supplements Health & Education Act

Answer 17

FDA is responsible for taking action

against any unsafe dietary supplement

Question 18

Food Quality ProtectionAct

Answer 18

• Reinvestigated pesticide tolerance levels

* Developed stricter pesticide safety standards, especially for children

Question 19

Therapeutic effect

Answer 19

Intended physiological effect of the drug

Question 20

Indication

Answer 20

Medical conditions or diseases for whichthe drug is meant to be used

Question 21

Contraindication

Answer 21

Conditions/circumstances for which thedrug should NOT be used

Question 22

Caution

Answer 22

Conditions or types of patients that

warrant closer observation for specificside effects

Question 23

Side effect

Answer 23

Unintended effects other than therapeutic effect

• May or may not be negative

Question 24

Adverseeffect

Answer 24

side effect that is negative

Question 25

Toxic effect/Toxicity

Answer 25

Adverse effect of a drug resulting in drugpoisoning, can be life-threatening

Question 26

Interaction

Answer 26

Drugs, supplements, or foods that may alter the | effect of the drug, and usually should not be givenduring the same course of therapy

Question 27

Agonists

Answer 27

drugsthat bind to a specific receptor & produce an action

Question 28

Antagonists

Answer 28

drugs that bind to specific receptors,prohibiting an | effect

Question 29

Competitive Antagonism

Answer 29

when both agonist and antagonist drugs bind to the same receptor and areadministered together

Question 30

MinimumDose

Answer 30

Smallest amount of a | drug that will produce atherapeutic effect

Question 31

MaximumDose

Answer 31

Largest amount of a | drug that will produce a desired effect WITHOUT producing symptoms of toxicity

Question 32

Loading Dose

Answer 32

Initial high dose used to quickly elevate blood | levels of the drug

Question 33

MaintenanceDose

Answer 33

Dose required to keepthe drug blood levels steady in order to maintain the desired effect

Question 34

TherapeuticDose

Answer 34

Dose that is customarily given to produce a | desired effect

Question 35

Toxic Dose

Answer 35

Amount of a drug that will produce harmful side effects or symptoms of poisoning

Question 36

(ED50)

Answer 36

Dose necessary toproduce half of the maximum response

Question 37

(LD50)

Answer 37

Dose that will kill 50% of animals tested

Question 38

Therapeutic Index (TI)

Answer 38

TI = LD50/ED50

Question 39

Hypersensitivity:

Answer 39

milder response, | usually rash, hives, itching, runny nose

Question 40

Anaphylaxis:

Answer 40

Severe, possibly fatal reaction - urticaria, vascular collapse, low BP, shock, cyanosis, laryngeal edema, bronchoconstriction, dyspnea

Question 41

Idiosyncrasy

Answer 41

* Unique, unusual, or unexpected response | * Genetic variations in enzymes, alters drug metabolism

Question 42

Paradoxical

Answer 42

Opposite effect from what isexpected

Question 43

Tolerance

Answer 43

Decreased response thatdevelops after repeated | doses are given

Question 44

Dependence

Answer 44

Acquired need for a drug, may produce psychologicalor physical symptoms of withdrawal when discontinued