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

Question 1

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

Answer 1

False

Question 2

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

Answer 2

False

Question 3

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

Answer 3

True

Question 4

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 5

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

Question 6

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

Question 7

Phase 2 trials utilize a double-blind placebo design.

Question 8

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

Question 9

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

Question 10

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

Question 11

A drug patent has a fixed duration of twelve years.

Question 12

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

Question 13

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

Question 14

Phase 2 trials are typically conducted on healthy human volunteers.

Question 15

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

Question 16

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

Question 17

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

Question 18

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

Question 19

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

Question 20

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

Question 21

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

Question 22

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

Question 23

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

Question 24

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

Question 25

Aspirin erodes the stomach wall.

Question 26

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

Question 27

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 28

Aspirin is a common name for the drug acetaminophen.

Question 29

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 30

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

Question 31

Without a doubt,FDA-approved drugs are safe.

Question 32

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

Question 33

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

Question 34

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

Question 35

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

Question 36

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

Question 37

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

Question 38

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 39

NSAIDs are only prescription drugs.

Question 40

An antipyretic drug can bring your body temperature down.

Question 41

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

Question 42

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 43

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

Question 44

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

Question 45

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)and it also has the responsibility for regulating OTC drugs
D)and it shares responsibility for regulating OTC drugs with several other agencies

Question 46

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

Question 47

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 48

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 49

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 50

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

Question 51

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

Question 52

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

Question 53

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 54

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 55

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 56

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

Question 57

The FDA refers to the __________.

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

Question 58

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

Question 59

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

Question 60

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 61

In Phase 1 Clinical trials,__________.

A)absorption rates are already known
B)no clinical populations are involved
C)dosage levels have already been determined
D)all of the above

Question 62

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 63

FDA approval of an IND application essentially grants permission to __________.

A)conduct animal testing
B)conduct human testing
C)begin distribution as a new prescription drug
D)begin Phase 2 trials

Question 64

The Anti-Tampering Act of 1983 requires __________.

A)all OTC drugs have tamper-resistant packaging
B)pharmacists must inspect prescription drugs to ensure they were not tampered with before distribution
C)child safety caps be present on all prescription bottles
D)all of the above

Question 65

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 66

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 67

In Phase 1 clinical trials,__________.

A)certain pharmacological questions are answered
B)no clinical populations are involved
C)safe dosage levels are determined
D)all of the above

Question 68

Healthy volunteers are used during _______ of clinical prescription drug studies.

A)Phase 1 trials
B)Phase 2 trials
C)Phase 3 trials
D)Phase 4 trials

Question 69

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 70

_________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 71

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 72

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 73

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 74

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 75

The letters IND (as in IND application)stand for __________.

A)the Initial Application for a New Drug
B)the Introduction of a New Drug Petition
C)Notice of Claimed Investigational Exemption for a New Drug
D)Initial Notification to Begin Drug Testing

Question 76

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

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

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

Question 78

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 79

In 1976,the FDA became responsible for the sale of __________.

A)orphan drugs
B)drugs with color additives
C)healthcare or medical devices
D)all of the above

Question 80

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)all of the above