Deck 14: Prescription Drugs, Over-The-Counter Drugs, and Natural Health Products

Question 1

Phase 2 trials utilize a double-blind placebo design.

Answer 1

True

Question 2

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

Answer 2

True

Question 3

A CTA is submitted to Health Canada following the successful completion of Phase 3 clinical trials.

Answer 3

False

Question 4

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

Question 5

The Therapeutic Products Directorate (TPD) is responsible for the safety and effectiveness of prescription drugs, but not for the safety or effectiveness of OTC drugs.

Question 6

A drug patent has a fixed duration of 12 years.

Question 7

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

Question 8

OTC drugs do not have any toxic effects.

Question 9

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

Question 10

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

Question 11

Phase 2 trials are typically conducted on healthy human volunteers.

Question 12

Initial testing of the safety of a drug takes place during clinical trials in humans.

Question 13

The first stage of clinical drug testing that makes use of human subjects is Phase 2.

Question 14

Natural health products are the most regulated of the three major classes of drugs.

Question 15

Natural health products are regulated the same way in Canada as in the United States.

Question 16

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 17

Health Canada classifies physiologically active consumer products into three major categories: prescription drugs, OTC drugs, and dietary supplements.

Question 18

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

Question 19

The TPD classifies any substance that is used for disinfection in food manufacturing facilities as a drug.

Question 20

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

Question 21

An antipyretic drug can bring your body temperature down.

Question 22

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

Question 23

Handwritten prescriptions can sometimes lead to an inappropriate medication being dispensed, due to the similarity among some drug names.

Question 24

The large number of elderly people taking multiple medications increases the risk of unintentional drug misuse.

Question 25

A regular aspirin regimen has no effect on the risk of heart attacks.

Question 26

Canada consumes the highest per capita amount of prescription opioids in the world.

Question 27

NSAIDs are only prescription drugs.

Question 28

Natural health products that have not fully been evaluated by Health Canada will contain an exemption number on their product label.

Question 29

The use of natural analgesics, such as that derived from willow bark, dates back to 1898.

Question 30

Alcohol was involved in two-thirds of drug-related ED visits concerning prescription and OTC drugs.

Question 31

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

Question 32

Since 2004, there has not been an increase in the number of drug brand names that look or sound alike.

Question 33

Acetaminophen should not be given to anyone under the age of 20 because of a risk of developing Reye's syndrome.

Question 34

Unintentional drug misuse is an especially serious concern among the elderly.

Question 35

All generic drugs must demonstrate bioequivalence and equal bioavailability to that of the original brand name drug.

Question 36

Aspirin erodes the stomach wall.

Question 37

Aspirin is a common name for the drug acetaminophen.

Question 38

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

Question 39

All Health Canada approved drugs are completely safe.

Question 40

It is advisable not to administer aspirin to individuals under the age of 20.

Question 41

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 42

Cough-and-cold medications, particularly those containing the nasal decongestant pseudoephedrine, present health risks in young children.

Question 43

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

Question 44

What is the name of the national authority that regulates medicinal drugs in Canada?

A) Therapeutic Products Department
B) Treatment Product Designate
C) Therapeutic Products Directorate
D) Therapies and Prescriptions Declarant

Question 45

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

Question 46

The TPD follows which set of criteria for defining a drug?

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

Question 47

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

Question 48

As of 2010, manufacturers of dietary supplements in the United States 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

Which of the following would be classified as a drug by the TPD?

A) a sleep aid
B) a commercial kitchen sanitizer
C) a skin moisturizer with herbal ingredients
D) both A and B

Question 50

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

Question 51

When taking over-the-counter (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 52

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

Question 53

The Therapeutic Products Directorate (TPD) is responsible for regulating __________.

A) prescription drugs
B) prescription drugs and OTC drugs
C) prescription drugs, OTC drugs, and all natural health products
D) prescription drugs, OTC drugs, and some natural health products

Question 54

In Canada, products such as vitamins, minerals, or herbal preparations are classified as __________.

A) natural health products
B) dietary supplements
C) OTC drugs
D) both A and B

Question 55

Which of the following best describes the regulation of natural health products in Canada?

A) Natural health products are always regulated in the same way as drugs.
B) Whenever natural health products make a therapeutic claim, they are regulated the same way as drugs.
C) Natural health products are always regulated differently than drugs.
D) Natural health products undergo evaluation when they are first released on the market but are unregulated after that.

Question 56

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 57

The TPD regulates natural health products __________.

A) never
B) always
C) when they are first released on the commercial market
D) when they make therapeutic claims

Question 58

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

Question 59

Which of the following is an example of a natural health product?

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

Question 60

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

Question 61

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 62

Analogy: Canada is to the Unites States as __________.

A) natural health product is to dietary supplement
B) dietary supplement is to natural health product
C) OTC drug is to natural health product
D) dietary supplement is to OTC drug

Question 63

The abbreviation CTA (as in the application concerning a new drug) stands for __________.

A) Clinical Trial Application
B) Canadian Testing Authority
C) Clinical Testing Authorization
D) Clinical Testing Advancement

Question 64

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 65

Double-blind studies are particularly important in __________.

A) animal studies
B) Phase 2 trials
C) Phase 1 trials
D) both A and B

Question 66

Approval of a CTA in Canada essentially grants permission to __________.

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

Question 67

Preliminary studies about the toxicity of a new drug must include the determination of the __________.

A) LD50
B) ED50
C) LD5
D) ED5

Question 68

A double-blind study means __________.

A) the patient is unaware whether he or she is taking a placebo or the actual drug, though the doctor is aware of which drug was taken
B) the doctor is unaware whether the patient is taking a placebo or the actual drug, though the patient is aware of which drug was taken
C) both the doctor and the patient are unaware of whether a placebo or the actual drug was taken
D) only a limited number of staff know what the patient is taking

Question 69

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 70

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 71

Analogy: Phase 1 trials are to Phase 2 trials as __________.

A) animals are to humans
B) toxicity is to dosage level
C) healthy volunteers are to human patients
D) prison inmates are to medical students

Question 72

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

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

Question 73

Which of the following must be completed before an application for drug approval can be started with Health Canada?

A) Purification of the drug's active ingredients
B) Market research regarding the need for the drug
C) Extensive toxicity tests in three species of laboratory animals
D) all of the above

Question 74

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 75

It is important to make sure that the participants in Phase 2 drug trials are __________.

A) healthy volunteers
B) laboratory animals
C) terminally ill
D) free of health problems, except for the condition the drug is intended to treat

Question 76

Preliminary studies on new drugs must be conducted on __________ before an application for drug approval can even be started with Health Canada.

A) animals
B) university students
C) pregnant women
D) all of the above

Question 77

Phase 2 clinical trials differ from Phase 1 clinical trials in that Phase 2 trials involve __________.

A) testing the new drug on 100 to 500 patients with the medical condition or disorder
B) normal, healthy volunteers
C) single-blind methods
D) several thousand patients all having a particular disorder

Question 78

During the testing of a new drug, human studies begin in __________.

A) the preliminary studies
B) Phase 1
C) Phase 2
D) Phase 3

Question 79

Prior to clinical trials, a drug company must receive approval of their application from __________.

A) Health Canada
B) a research ethics board
C) both A and B
D) neither A nor B

Question 80

A very large population of clinical patients (between 1000 to 3000) is involved at which stage of the Health Canada approval process for new drugs?

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