Deck 14: Prescription Drugs, Over-The-Counter Drugs, and Dietary Supplements

Question 1

4 Dietary supplements are the most regulated of the three major classes of OTC drugs.

Answer 1

False

Question 2

6 Compare and contrast aspirin (ASA)with acetaminophen in terms of their medical benefits and their adverse side effects.

Answer 2

no answer

Question 3

9 Until an amendment to the FDC Act in 1951,there was no clear distinction between prescription and OTC drugs.

Answer 3

True

Question 4

1 There is a greater quantity of available OTC drugs than prescription drugs.

Question 5

5 The Dietary Supplement Health and Education Act of 1994 requires the FDA to evaluate the effectiveness of dietary supplements.

Question 6

13 If a medication is eventually going to be marketed for a chronic condition,toxicity studies in animals must simulate a period of time that the consumer would use the drug.

Question 7

10 The result of the Kefauver-Harris Amendment of 1962 was that effectiveness as well as safety of new drugs must be proved before the drug is put on the market.

Question 8

6 Prior to 1906,drugs did not have to be honestly labeled with regard to their ingredients.

Question 9

4 What have been the effects of the Over-the-Counter Review (OTC Review)on the availability of nonprescription medicines?

Question 10

2 Describe the history of prescription drug regulations and why they are important.

Question 11

3 Prescription drugs have a higher margin of safety than do OTC drugs.

Question 12

1 Discuss the differences in safety level and the extent of medical supervision between prescription and over-the-counter (OTC)drugs.

Question 13

8 After the passage of the 1938 Food,Drug,and Cosmetic Act,all new drugs had to be certified as safe and effective when used.

Question 14

5 Prescription drugs are safe in their recommended use but toxic in misuse.Explain with examples.

Question 15

12 Prior to clinical trials,specific tests must be done on pregnant laboratory animals to determine whether a drug under development causes birth defects.

Question 16

7 The Pure Food and Drug Act of 1906 guaranteed that drugs were useful and safe as long as ingredients were clearly labeled.

Question 17

3 Describe Phases 1,2,3,and 4 clinical trials in the FDA approval process in terms of the goals of each and the population that is involved.

Question 18

2 The FDA is responsible for the safety and effectiveness of prescription drugs,but not for the safety or effectiveness of OTC drugs.

Question 19

11 Establishing an LD50 for a new drug is accomplished prior to clinical trials.

Question 20

7 Discuss two problems associated with the use of OTC cough and cold remedies.

Question 21

27 In recent years,screening out drugs that may be potentially harmful has been a higher priority than providing drugs in an expeditious manner.

Question 22

31 In 2008,the U.S.Pharmacopeia identified double the number of pairs of drug brand names that looked or sounded alike than it had identified in 2004.

Question 23

26 Without a doubt,FDA-approved drugs are safe.

Question 24

32 OTC drugs,by definition,do not have any side effects.

Question 25

19 The length of time that a patent is in effect starts when the drug is put on the market.

Question 26

16 An IND is submitted to the FDA following the successful completion of Phase 3 clinical trials.

Question 27

18 A drug patent has a fixed duration of twelve years.

Question 28

33 The FDA estimates that over a period of 20 years,the barcode-based medication administration system will have prevented 500,000 adverse drug events and achieved a 50 percent reduction in the likelihood of medication errors.

Question 29

21 The FDA approval process can be shortened for drugs designed to help seriously ill people.

Question 30

20 Bioequivalence refers to two drug compounds having identical chemical and pharmacological effects.

Question 31

23 As a result of the Kafauver-Harris Amendment of 1962,all OTC and prescription drugs must be determined to be GRAS,GRAE,and GRAHL.

Question 32

25 Monistat,Benadryl,and Pepcid AC are three examples of OTC drugs that were once only available on a prescription basis.

Question 33

17 Phase 4 trials occur after a drug is released to the public.

Question 34

15 Phase 2 trials utilize a double-blind placebo design.

Question 35

24 OTC antihistamines are stronger at the present time than they have been in the past.

Question 36

28 The FDA has recently been approving more drugs than in previous years.

Question 37

29 In 2009,the FDA approved only twenty-six new drugs with active ingredients that had never previously been marketed in the U.S.

Question 38

14 Phase 2 trials are typically conducted on healthy human volunteers.

Question 39

22 Bioavailability is the rate at which a drug enters the circulation and reaches its site of action.

Question 40

30 Handwritten prescriptions can be confusing to pharmacists,leading to an inappropriate medication being dispensed.

Question 41

45 Ibuprofen does not interfere with aspirin's ability to protect against recurring heart attacks.

Question 42

47 The only two FDA-approved active ingredients in sleep aids are both antihistamines.

Question 43

44 Acetaminophen is particularly suited for the treatment of inflammation of the joints.

Question 44

35 NSAIDs are only prescription drugs.

Question 45

48 Cough and cold remedies reduce the length of time a cold is in one's system.

Question 46

36 An antipyretic drug can bring your body temperature down.

Question 47

39 Aspirin is safe for pregnant women to take because it relieves the pain of childbirth.

Question 48

49 Cough and cold remedies can be safely combined with the intake of alcohol.

Question 49

46 The advantage of ibuprofen over naproxen is that ibuprofen has a substantially longer duration of action than does naproxen.

Question 50

3 In general,the margin of safety for OTC drugs __________.

A)is higher than for prescription drugs
B)is lower than for prescription drugs
C)needs to be,by law,equivalent to that of prescription drugs
D)may be higher or lower than for prescription drugs,depending upon the degree of access to the product

Question 51

40 Reye's syndrome is a dangerous disease marked by lethargy,nausea,vomiting,disorientation,and coma.

Question 52

37 "Genuine Bayer Aspirin" is the most effective form of aspirin.

Question 53

2 When taking OTC drugs,there are restrictions with regard to __________.

A)the disorder for which the drugs are taken
B)the dosage level that can be taken
C)the number of refills that can be purchased
D)none of the above

Question 54

41 Acetaminophen should not be given to anyone under the age of twenty because of a risk of developing Reye's syndrome.

Question 55

50 Cough and cold medications,particularly those containing the nasal decongestant pseudoephedrine,do not present health risks in young children.

Question 56

1 The FDA refers to the __________.

A)Federal Drug Association
B)Food and Drug Administration
C)Federal District Agency
D)Fair Drug Act

Question 57

43 Acetaminophen is a better analgesic drug than acetylsalicylic acid (ASA)for patients with stomach ulcers.

Question 58

42 It is advisable not to administer aspirin to individuals under the age of twenty.

Question 59

34 Aspirin is a common name for the drug acetaminophen.

Question 60

38 Aspirin erodes the stomach wall.

Question 61

23 Clinical testing of a new compound that has promise as a new prescription drug cannot begin until a(n)______ is submitted to the FDA.

A)IND
B)LD50
C)Phase 2 trial
D)none of the above

Question 62

20 Who is responsible for enforcing established policies and legislation regarding drugs?

A)FDA
B)CIA
C)FBI
D)state legislators

Question 63

13 The landmark federal legislation enacted in 1906 regarding medicinal produces was __________.

A)the Federal Food,Drug,and Cosmetic Act of 1906
B)the Pure Food and Drug Act of 1906
C)the Harrison Act of 1906
D)the Prescription Drug Regulation Act of 1906

Question 64

17 Research studies proving the safety of new drugs are required under which legislation?

A)the Pure Food and Drug Act
B)the Federal Food,Drug,and Cosmetic Act
C)the Kefauver-Harris Amendment
D)Hazardous Substance Labeling Act

Question 65

24 Prior to Phase 1 trials,a new drug must be tested in animals for possible __________.

A)impurities in its active ingredients
B)toxic effects
C)adverse effects during pregnancy
D)all of the above

Question 66

19 As a direct result of the Kefauver-Harris Amendment of 1962,new drugs now are required to be certified as __________.

A)pure and unadulterated
B)safe
C)honestly labeled
D)effective

Question 67

7 Which of the following is a dietary supplement?

A)an analgesic
B)a weight-loss aid
C)an herbal preparation
D)a cough and cold remedy

Question 68

5 The FDA has the responsibility for regulating prescription drugs __________.

A)while the FTC (Federal Trade Commission)has the responsibility for regulating OTC drugs
B)while few if any regulations exist for OTC drugs
C)as well as the responsibility for regulating OTC drugs
D)and it shares responsibility for regulating OTC drugs with several other agencies

Question 69

16 _________is the basis for all present-day U.S.food and drug laws.

A)The Pure Food and Drug Act of 1906
B)The Dietary Health and Education Act of 1994
C)The Federal Food,Drug,and Cosmetic Act of 1938
D)The Kefauver-Harris Amendment of 1962

Question 70

6 Which of the following does NOT belong to a drug category that is FDA-regulated?

A)analgesics
B)sleep aids
C)weight-loss aids
D)dietary supplements

Question 71

14 Until ____,drugs could still be useless and/or dangerous as long as the label listed the ingredients in a correct manner.

A)1906
B)1928
C)1938
D)1962

Question 72

22 One of the requirements of an IND application is __________.

A)the determination of an LD50
B)clinical trials for a specific population
C)the preparation of an honestly written label
D)an understanding of the proper dosage level

Question 73

9 As of 2010,manufacturers of dietary supplements must __________.

A)provide information to consumers about the risks and side effects of dietary supplements
B)show that the purity,strength,and composition of these products have been tested and that the labels are accurate descriptions of the contents
C)claim benefits with respect to the diagnosis,treatment,cure,or prevention of uncommon conditions or diseases
D)state that dietary supplements can be taken with or without a physician's recommendation

Question 74

4 OTC drugs __________.

A)are available by prescription only
B)are free of toxic effects
C)have a high potential for misuse
D)have a lower margin of safety than prescription drugs

Question 75

10 Prior to 1906,the only guarantee when purchasing a medicinal product was __________.

A)that it was unadulterated and pure
B)that it was honestly labeled
C)both A and B
D)neither A nor B

Question 76

21 If a drug needs to be marketed for a chronic disorder,__________.

A)toxicity studies must be extended over a longer period of time
B)an LD75 must be established
C)laboratory testing must be done in more than five different locations
D)laboratory testing must include human participants

Question 77

11 The legislation that required all foods and drugs in the United States be clearly and accurately identified on the label is __________.

A)the Pure Food and Drug Act of 1906
B)the Dietary Supplement Health and Education Act
C)the Federal Food,Drug,and Cosmetic Act
D)the Kefauver-Harris Amendment

Question 78

8 According to the Dietary Supplement Health and Education Act of 1994,__________.

A)dietary supplements should not be taken without a physician's recommendation
B)manufacturers are able to claim the product's benefits to treat uncommon conditions
C)manufacturers must provide information to consumers about the risks and side effects of dietary supplements
D)dietary supplements do not have to be proved safe and effective

Question 79

18 An amendment to the FDC Act,enacted in 1951,made the distinction for the first time between __________.

A)prescription versus OTC drugs
B)safe versus unsafe drugs
C)drugs versus cosmetics
D)effectiveness versus ineffectiveness

Question 80

12 Following the enactment of federal legislation in 1906,all drugs in the U.S.had to be __________.

A)pure and unadulterated
B)safe when used as directed
C)effective for the disorders described
D)safe and reasonably priced