DAB CH 14
As of 1999, clinical trials of new drugs are required to consider the special metabolic processes of which population? 1 A. children B. men in their 20s C. men in their 30s D. men in their 40s
1 A. children
Which of the following is NOT a brand name for ibuprofen? A. Midol 1 B. Tylenol C. Advil D. Motrin
1 B. Tylenol
The generic name for Tylenol is A. ASA 1 B. acetaminophen C. aspirin D. ibuprofen
1 B. acetaminophen
Who would benefit the most from "enteric-coated" aspirin? A. healthy elderly people 1 B. people with stomach ulcers C. women in their final month of pregnancy D. obese people
1 B. people with stomach ulcers
To help ensure the correct medication is given to the correct patient at the correct time the FDA plans in the future to use 2 A. a bar-coded identification system B. a smaller patient to hospital staff ratio C. a card similar to a credit card used to track medical history D. a joint computer system between hospitals and pharmacies
2 A. a bar-coded identification system
Bioequivalence refers to the absolute chemical and pharmacological identity of Ingredients 2 A. between generic and brand-name versions B. among separate batches of a prescription drug C. over the life of a drug patent D. being clearly stated to the consumer
2 A. between generic and brand-name versions
Dr. Frances Kelsey was able to prevent distribution of thalidomide in the United States in her role as a 2 A. medical officer at the FDA B. U.S. congresswoman C. prominent journalist whose writings influenced public opinion D. drug-safety activist
2 A. medical officer at the FDA
When a new drug is approved for prescription use, it is likely that several years have passed since 2 A. the drug was first synthesized and testing begun B. the drug began Phase 1 clinical trials C. the drug began Phase 2 clinical trials D. the drug began Phase 3 clinical trials
2 A. the drug was first synthesized and testing begun
Ginkgo biloba has been shown to produce modest improvements among A. clinical depressive patients 2 B. Alzheimer's disease patients C. heroin abusers D. bodybuilders
2 B. Alzheimer's disease patients
Sleep-aids fall into which drug category? A. CNS stimulants 2 B. CNS depressants C. opiates D. none of the above
2 B. CNS depressants
Relatively speaking, which of the following people is the best candidate for aspirin? A. a 60 year old patient going into open heart surgery 2 B. a 50 year old woman who has no history of stomach ulcers C. a 15 year old healthy boy D. a 40 year old man with a history of intestinal bleeding
2 B. a 50 year old woman who has no history of stomach ulcers
Which of the following does NOT have an association with kidney damage? A. acetaminophen 2 B. aspirin C. ibuprofen D. all of the above
2 B. aspirin
Aspirin produces its analgesic effects as a result of A. stimulating prostaglandins 2 B. blocking prostaglandins C. stimulated morphine-sensitive receptors D. blocking morphine-sensitive receptors
2 B. blocking prostaglandins
Aspirin intake carries an increased risk of A. headache pain 2 B. gastric bleeding C. vaginal bleeding D. increased blood clotting
2 B. gastric bleeding
According to the DAWN reports, most of ED visits associated with prescription drugs A. occur from prescription drugs alone 2 B. involve the combination of multiple drugs C. involve the combination with the antianxiety drug, Valium D. involve children under the age of 5
2 B. involve the combination of multiple drugs
The main disadvantage of salicylic acid is that A. too many ED mentions result from its ingestion 2 B. it is very irritating to the stomach C. moderate doses produce hallucinations D. it is more expensive than acetaminophen
2 B. it is very irritating to the stomach
In Phase 1 clinical trials, A. absorption rates are already known 2 B. no clinical populations are involved C. dosage levels have already been determined D. all of the above
2 B. no clinical populations are involved
The net effect of a "treatment IND" is to A. establish bioequivalent generic versions of a drug 2 B. speed up the FDA approval process C. widen the population involved in Phase 2 and 3 clinical trials D. limit the number of new drugs being evaluated by the FDA
2 B. speed up the FDA approval process
The landmark federal legislation enacted in 1906 regarding medicinal produces was A. the Federal Food, Drug, and Cosmetic Act of 1906 2 B. the Pure Food and Drug Act of 1906 C. the Harrison Act of 1906 D. the Prescription Drug Regulation Act of 1906
2 B. the Pure Food and Drug Act of 1906
The DESI process has been set up to evaluate A. the effectiveness of existing OTC drugs 2 B. the effectiveness of existing prescription drugs C. the safety of existing OTC drugs D. the safety of existing prescription drugs
2 B. the effectiveness of existing prescription drugs
The legislation that required all foods and drugs in the United States be clearly and accurately identified on the label is 3 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
3 A. the Pure Food and Drug Act of 1906
______ is a recognized medical antidote for acetaminophen overdose. A. Tylenol 3 B. Acetylcysteine (Mucosil) C. Ibuprofen D. Naproxen
3 B. Acetylcysteine (Mucosil)
Kidney damage has been linked to heavy use or moderate cumulative use of A. acetylsalicylic acid 3 B. acetaminophen C. both acetaminophen and acetylsalicylic acid D. acetic acid
3 B. acetaminophen
The only FDA-approved active ingredient(s) in OTC sleep aids is (are) the following: A. diphenhydramine 3 B. diphenhydramine and doxylamine succinate C. diphenhydramine and opium D. any drug as long as it is an antihistamine
3 B. diphenhydramine and doxylamine succinate
In the year 2000, "thalidomide" babies were A. teenagers 3 B. in their late 30s or early 40s C. in their 80s D. around 65 years old
3 B. in their late 30s or early 40s
Research studies proving the safety of new drugs are required under which legislation? A. the Pure Food and Drug Act 3 B. the Federal Food, Drug, and Cosmetic Act C. the Kefauver-Harris Amendment D. Hazardous Substance Labeling Act
3 B. the Federal Food, Drug, and Cosmetic Act
With regard to the duration of a patent, the "clock" starts upon submission of A. the NDA 3 B. the original IND C. the beginning of human clinical trials D. the beginning of Phase 3 trials
3 B. the original IND
Aspirin is synonymous with A. ASA 1 B. ACTH C. ACh D. ACS
A. ASA
Who is responsible for enforcing established policies and legislation regarding drugs? A. FDA 1 B. CIA C. FBI D. state legislators
A. FDA
The drug thalidomide is currently used to treat A. Hansen's disease (formerly known as leprosy) 2 B. neurological tremors C. morning sickness in pregnant women D. insomnia
A. Hansen's disease (formerly known as leprosy)
Clinical testing of a new compound that has promise as a new prescription drug cannot begin until a(n) ______ is submitted to the FDA. 3 A. IND B. LD50 C. Phase 2 trial D. none of the above
A. IND
After successful completion of Phase 3 clinical trials, the pharmaceutical company submits a(n) A. NDA B. IND C. CPO D. FDA
A. NDA
The decision to make the prescription drug called naproxen available as an OTC drug called Aleve has been a direct result of the A. OTC Review B. DESI C. Kefauver-Harris Amendment D. Truth in Prescribing Act of 1994
A. OTC Review
Healthy volunteers are used during _______ of clinical prescription drug studies. A. Phase 1 trials 1 B. Phase 2 trials C. Phase 3 trials D. Phase 4 trials
A. Phase 1 trials
The leading OTC pain-relieving drug in the United States is A. acetaminophen 1 B. ASA C. aspirin D. ibuprofen
A. acetaminophen
Genuine Bayer's Aspirin" is the same as A. acetylsalicylic acid (ASA) 2 B. acetaminophen C. ibuprofen D. naproxen
A. acetylsalicylic acid (ASA)
The Anti-tampering Act of 1983 requires A. all OTC drugs have tamper-resistant packaging 1 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
A. all OTC drugs have tamper-resistant packaging
Andy has a persistent cough. Which property of cough-and-cold remedies would help? A. antitussive 1 B. sedative C. decongestant D. antipyretic
A. antitussive
Including an antipyretic drug in a cough-and-cold remedy would serve to A. bring down a fever 1 B. reduce the headache C. reduce the thickness of mucus in the throat D. suppress the cough
A. bring down a fever
Reye's syndrome is a serious condition that can accompany the following disease: A. chicken pox or the flu 1 B. bacterial meningitis C. congestive heart disease D. liver cancer
A. chicken pox or the flu
Once a drug "goes off patent," A. generic versions can be marketed 2 B. generic versions must be marketed under the former brand-name C. the original drug company is forbidden to sell its prescription drug any longer D. bioequivalency requirements are suspended for one year
A. generic versions can be marketed
As a direct result of the Kefauver-Harris Amendment of 1962, new drugs A. had to be effective for specific disorders 3 B. had to be evaluated in animals for ten years before they could proceed to evaluation in clinical trials with human patients C. had to be labeled in plain English D. had to be sold at a significant discount to elderly patients
A. had to be effective for specific disorders
Phase 2 clinical trials differ from Phase 1 clinical trials in that Phase 2 trials now involve A. human patients as subjects 1 B. normal, healthy volunteers C. questions of dosage and purity D. several thousand patients all having a particular disorder
A. human patients as subjects
Ginkgo biloba A. improves blood circulation 2 B. improves cognitive functioning in healthy adults C. helps alleviate muscle aches D. functions as an antihistamine
A. improves blood circulation
Antioxidants A. inhibit platelets in the blood from sticking together 1 B. help the lungs to filter oxygen C. decrease white blood cells D. decreases blood flow to the brain
A. inhibit platelets in the blood from sticking together
In general, the margin of safety for OTC drugs A. is higher than for prescription drugs 2 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
A. is higher than for prescription drugs
A "downside" to using enteric-coated aspirin is that A. it takes longer to reduce pain 1 B. it erodes stomach walls leading to ulcers C. it cannot be taken if the patient has fever D. it reduces histamines in the blood
A. it takes longer to reduce pain
Naproxen is different from all the other OTC pain relievers in that A. its effects last from 8 to 12 hours 2 B. it is effective in reducing inflammation C. it does not cause gastrointestinal irritation D. it is available on a nonprescription basis
A. its effects last from 8 to 12 hours
A pharmaceutical company that distributes aspirin A. might market acetaminophen as well 2 B. might also market ibuprofen but be forbidden to market acetaminophen C. is forbidden by law to market other analgesics D. might market acetaminophen but be forbidden to market iboprofen
A. might market acetaminophen as well
The Drug Efficacy Study Investigation (DESI) examined A. prescription drugs only 2 B. OTC drugs only C. illicit drugs D. both A and B
A. prescription drugs only
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
A. prescription versus OTC drugs
Following the enactment of federal legislation in 1906, all drugs in the U.S. had to be A. pure and unadulterated 2 B. safe when used as directed C. effective for the disorders described D. all of the above
A. pure and unadulterated
A possible sensory side effect of aspirin is A. ringing in the ears and deafness 2 B. reduction in tear flow to the eyes C. increased sensitivity to the skin D. disruption in color vision and burning in the eyes
A. ringing in the ears and deafness
One of the requirements of an IND application is A. the determination of an LD50 2 B. clinical trials for a specific population C. the preparation of an honestly written label D. an understanding of the proper dosage level
A. the determination of an LD50
According to the text, the phrase "the other drug war" refers to A. the high cost of prescription drugs 2 B. the fight against prescription drug misuse C. the problem of adulterated prescription drugs D. the battle between Genuine Bayer Aspirin and Tylenol for market share
A. the high cost of prescription drugs
The main goal of the Kefauver-Harris Amendment of 1962 was: A. to require all drugs to be safe and effective 2 B. to have pharmacists place stickers on prescription bottles warning patients of special instructions C. to allow doctors to call in prescriptions to pharmacists rather than write paper prescriptions D. to establish a minimum age for purchasing OTC drugs
A. to require all drugs to be safe and effective
If a drug needs to be marketed for a chronic disorder, A. toxicity studies must be extended over a longer period of time 2 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
A. toxicity studies must be extended over a longer period of time
One of the adverse side effects of ginseng is A. uterine bleeding in post-menopausal women 2 B. drowsiness C. dependence D. an increased tendency to abuse alcohol
A. uterine bleeding in post-menopausal women
The Physician's Desk Reference for prescription drugs is frequently used to A. warn physicians of the adverse effects of different drugs 3 B. help to diagnose various health problems C. monitor patients taking new drugs D. none of the above
A. warn physicians of the adverse effects of different drugs
As a direct result of the Kefauver-Harris Amendment of 1962, new drugs now were required to be certified as 3 A. pure and unadulterated B. safe C. honestly labeled D. effective
Ans:D
The FDA refers to the A. Federal Drug Association 1 B. Food and Drug Administration C. Federal District Agency D. Fair Drug Act
B. Food and Drug Administration
The Federal Food, Drug, and Cosmetic (FDC) Act was enacted under the administration of President 1 A. Richard Nixon B. Franklin D. Roosevelt C. Harry Truman D. Lyndon B. Johnson
B. Franklin D. Roosevelt
Double blind studies are particularly important in A. animal studies B. Phase 2 trials C. Phase 1 trials D. both A and B
B. Phase 2 trials
Since 1993, the following change in the clinical testing of new drugs has been made: A. No woman can serve as a subject on the grounds that she might be pregnant 3 during testing. B. The ban on women participating in clinical trials has been lifted. C. It is illegal to consider racial or ethnic information in the testing of new drugs. D. Elderly patients are specifically barred from participating, on the grounds that unknown factors might produce adverse side effects.
B. The ban on women participating in clinical trials has been lifted.
Serious problems can occur when cough-and-cold remedies include _______ in their formulation. 2 A. acetaminophen B. alcohol C. codeine D. ibuprofen
B. alcohol
Relief of itching, sneezing and teary eyes would be produced by an OTC drug having the following property: 1 A. antitussive B. antihistamine C. antipyretic D. anti-inflammatory
B. antihistamine
The likelihood of a medical emergency increases dramatically when prescription and OTC drugs 1 A. are taken in times of stress and anxiety B. are combined with alcohol C. are taken in the evening hours D. are ingested by teenagers
B. are combined with alcohol
The major adverse side effect of thalidomide when taken by pregnant women is the development of 2 A. premature contractions B. birth defects in the newborn C. brain tumors D. miscarriage or spontaneous abortions
B. birth defects in the newborn
An increased risk of Reye's syndrome is the reason why there is the recommendation that aspirin should not be taken 2 A. by elderly individuals B. by individuals under the age of twenty C. by individuals undergoing surgery D. by individuals trying to prevent heart attacks
B. by individuals under the age of twenty
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
B. conduct human testing
The risk of liver damage due to acetaminophen is increased when_________ is taken along with it. 2 A. any quantity of alcohol B. more than two alcoholic drinks per day C. any quantity of aspirin D. any quantity of Tylenol
B. more than two alcoholic drinks per day
In the 1950s, thalidomide was a new drug marketed to A. young children for sore throats 2 B. pregnant women for morning sickness C. elderly individuals for depression D. insomnia
B. pregnant women for morning sickness
As of 2010, manufacturers of dietary supplements must p.335 A. provide information to consumers about the risks and side effects of dietary 2 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
B. show that the purity, strength, and composition of these products have been
Paradoxically, many antihistamines may produce ______ in young children. A. drowsiness B. stimulation C. an increase in cold symptoms D. clogged sinuses
B. stimulation
The public should be cautious when purchasing medications via the Internet because A. medications available online are overpriced 1 B. the dispenser may not have the proper licensing credentials C. health insurance is required for all purchases D. purchasing medication online is a federal offense
B. the dispenser may not have the proper licensing credentials
A prescription drug patent has a fixed duration of A. 5 years 2 B. 10 years C. 20 years D. 30 years
C. 20 years
The completion of Phase 1, Phase 2, and Phase 3 drug trials is usually a process that takes about _______ or more to complete. 2 A. six months B. 1 year C. 3 years D. 12 years
C. 3 years
A very large population of clinical patients (between 1,000 to 3,000) are involved in the p.338 following stage of the FDA approval process for new drugs: 2 A. Phase 1 B. Phase 2 C. Phase 3 D. Phase 4
C. Phase 3
Possible side effects of a new drug within a very large clinical population are evaluated in 1 A. Phase 1 trials B. Phase 2 trials C. Phase 3 trials D. animal studies
C. Phase 3 trials
__________is known as the basis for all present-day U.S. food and drug laws. A. The Pure Food and Drug Act of 1906 2 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
C. The Federal Food, Drug, and Cosmetic Act of 1938
Acetaminophen would NOT be recommended for A. headache relief 2 B. fever reduction C. a reduction in arthritic inflammation D. all of the above
C. a reduction in arthritic inflammation
Which of the following is NOT one of the nonsteroidal anti-inflammatory drugs (NSAIDs) A. aspirin 2 B. ibuprofen C. acetaminophen D. naproxen
C. acetaminophen
ASA is an abbreviation for A. acetaminophen sodium amylate 3 B. acetaldehyde salitic acid C. acetylsalicylic acid D. acetostrombic acetate
C. acetylsalicylic acid
Cough and cold remedies can A. cure the common cold 1 B. reduce the length of time the common cold is in one's system C. alleviate the symptoms experienced with the common cold D. both B and C
C. alleviate the symptoms experienced with the common cold
MedWatch is a federal program that p.339 A. monitors licit drug use among health professionals 1 B. physicians use to decide which drug to prescribe patients C. allows physicians to report adverse effects of prescription drugs D. withdraws unsafe drugs from the market
C. allows physicians to report adverse effects of prescription drugs
Which of the following is a dietary supplement? A. an analgesic 2 B. a weight-loss aid C. an herbal preparation D. a cough and cold remedy
C. an herbal preparation
The FDA has the responsibility for regulating prescription drugs A. while the FTC (Federal Trade Commission) has the responsibility for 2 regulating OTC drugs B. while few if any regulations exist for OTC drugs C. and it also has the responsibility for regulating OTC drugs as well D. and it shares responsibility for regulating OTC drugs with several other agencies
C. and it also has the responsibility for regulating OTC drugs as well
The fever-reducing aspect of aspirin is referred to as its ________ property. A. anti-inflammatory 1 B. analgesic C. antipyretic D. none of the above
C. antipyretic
Aspirin reduces fever by A. enhancing the effect of endorphins 3 B. stimulating morphine-sensitive receptors C. blocking the effect of prostaglandins in the hypothalamus D. blocking the effect of prostaglandins in the medulla
C. blocking the effect of prostaglandins in the hypothalamus
Surgical patients should not take aspirin prior to their surgery because A. the gastric irritation might complicate their recovery 1 B. the likelihood of contracting Reye's syndrome is increased C. blood clotting time is increased D. prostaglandin secretion will be increased
C. blood clotting time is increased
It is dangerous to take gingko biloba if the user is also taking A. diabetic medication 2 B. allergy medication C. blood thinning medication D. high blood pressure medication
C. blood thinning medication
A drug patent grants to the pharmaceutical company the following privilege(s): A. exclusive marketing rights 2 B. exclusive use of the drug's brand name C. both A and B D. neither A nor B
C. both A and B
Normally, an injury to the body will result in A. an elevation of prostaglandins 2 B. a tendency toward inflammation C. both A and B D. none of the above
C. both A and B
The OTC Review process has resulted in p.342 A. an increase in the acceptable dosage levels for selected OTC drugs 3 B. a transfer of some drugs from prescription to OTC status C. both A and B D. neither A nor B
C. both A and B
A double-blind study means A. the patient is unaware whether he or she is taking a placebo or the actual 1 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. none of the above
C. both the doctor and the patient are unaware of whether a placebo or the
Which of the following is more of a priority in recent years with regard to distributing drugs? 2 A. speed B. empathy C. caution D. personality
C. caution
If an OTC drug has antitussive properties, then it would be recommended for \ A. headache pain 2 B. reducing a fever C. controlling a cough D. opening up your clogged sinuses
C. controlling a cough
Monistat, Benadryl, and Actifed are some examples of OTC drugs that A. have been officially approved by the OTC Review 3 B. have been recently under criminal investigation by the FDA C. formerly have been prescription drugs D. were developed under the new "treatment IND" procedure
C. formerly have been prescription drugs
Two dietary supplements that are promoted to improve cognitive functioning are A. creatine and androstenedione B. St. John's wort and creatine C. gingko biloba and ginseng D. opium and cocaine
C. gingko biloba and ginseng
When a drug goes "off-patent" the manufacturing drug company A. can be issued an exclusive patent of its own for an additional 10 years 2 B. will be required to manufacture generic versions of the drug C. has the option to apply for FDA-approval for the drug to be marked as an OTC drug D. must prove bioequivalency between the original drug and the generic form
C. has the option to apply for FDA-approval for the drug to be marked as an
OTC drugs A. are available by prescription only 2 B. are free of toxic effects C. have a high potential for misuse D. have a lower margin of safety than prescription drugs
C. have a high potential for misuse
In 1976, the FDA became responsible for the sale of A. orphan drugs 3 B. drugs with color additives C. health-care or medical devices D. all of the above
C. health-care or medical devices
Analogy: Phase 1 trials are to Phase 2 trials as A. animals are to humans 3 B. toxicity is to dosage level C. healthy volunteers are to human patients D. prison inmates are to medical students
C. healthy volunteers are to human patients
In order to raise body temperature, prostaglandins act on which area of the brain? A. medulla 3 B. hippocampus C. hypothalamus D. hindbrain
C. hypothalamus
Acetaminophen has similar effects to ASA EXCEPT that it does not reduce A. fever 2 B. moderate headache pain C. inflammation D. none of the above
C. inflammation
If an OTC drug has expectorant properties, then it would A. be expected to cure a cold 1 B. stop your coughing C. make it easier to cough up mucus and phlegm D. make you drowsy
C. make it easier to cough up mucus and phlegm
Norflex and NorflocaxinIn are p.345 A. both medications to treat muscle spasms 3 B. both medications to treat bacterial infections100 to 300 C. medications to treat muscle spasms and bacterial infections, respectively D. actually two brand names for the same drug
C. medications to treat muscle spasms and bacterial infections, respectively
The letters IND (as in IND application) stand for A. the Initial application for a New Drug 3 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
C. notice of claimed Investigational exemption for a New Drug
Which of the following people would benefit most from acetaminophen? A. someone needing to reduce inflammation of the joints 1 B. someone who is drinking alcohol C. someone who has muscle aches D. someone on anticlotting medication
C. someone who has muscle aches
The Kefauver-Harris Amendment of 1962 was a response to the crisis (or near-crisis) p.336 regarding 2 A. Elixir Sulfanilamide B. the presence of bacteria in beef C. thalidomide D. the range of unsafe drugs that were available
C. thalidomide
In the case of the Elixir Sulfanilamide tragedy in 1937, the U.S. government intervened because 3 A. the drug was unsafe when used as directed B. the drug was ineffective for the disorders listed on the label C. the product has been mislabeled with regard to its ingredients D. the drug was far more effective than anything else on the market, and the profits of the manufacturer had been excessive
C. the product has been mislabeled with regard to its ingredients
Research and development costs to pharmaceutical companies now exceed _______ p.339 each year. 3 A. $500,000 B. $5 million C. $30 million D. $30 billion
D. $30 billion
Physicians' reports become a large part of the data in the following phase of clinical trials: 1 A. Phase 1 B. Phase 2 C. Phase 3 D. Phase 4
D. Phase 4
According to the Dietary Supplement Health and Education Act of 1994 A. dietary supplements should not be taken without a physician's 2 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. all dietary supplement products must be labeled as not having been evaluated by the FDA
D. all dietary supplement products must be labeled as not having been evaluated by the FDA
According to the DAWN reports, A. more ED visits involve cocaine, marijuana, and heroin than prescription drugs 2 B. prescription drugs are often involved in suicide attempts C. most prescription drug-related ED visits involve a combination of several drugs D. all of the above
D. all of the above
Acetaminophen is frequently preferred over aspirin because A. it does not reduce clotting 2 B. it does not produce gastric distress C. it is not linked to Reye syndrome D. all of the above
D. all of the above
Ibuprofen has the following properties: A. analgesic 2 B. antipyretic C. anti-inflammatory D. all of the above
D. all of the above
In Phase 1 clinical trials, A. certain pharmacological questions are answered 2 B. no clinical populations are involved C. safe dosage levels are determined D. all of the above
D. all of the above
Many people who do not have health insurance choose to A. order medications online 1 B. purchase medications from other countries C. order medications through mail-order catalogs D. all of the above
D. all of the above
People suffering from which of the following conditions should NOT take cough-and-cold remedies? 2 A. diabetes B. high blood pressure C. thyroid disease D. all of the above
D. all of the above
Prior to Phase 1 trials, a new drug must be tested in animals for possible A. impurities in its active ingredients 2 B. toxic effects C. adverse effects during pregnancy D. all of the above
D. all of the above
Prostaglandin blocking explains the following effect(s) of aspirin: A. analgesic 2 B. antipyretic C. anti-inflammatory D. all of the above
D. all of the above
The DESI and OTC Review processes required that all drugs be evaluated so they could p.341 be certified as 3 A. GRAE B. GRAS C. GRAHL D. all of the above
D. all of the above
The effects of sleep aids can be dangerously enhanced if used in conjunction with A. alcohol 1 B. antihistamines C. cough and cold remedies D. all of the above
D. all of the above
Actifed, Benadryl, and Dimetane are all A. prescription drugs 1 B. Schedule II drugs C. presently unavailable to the consumer D. antihistamines
D. antihistamines
Which of the following characteristic does NOT involve a medical application of aspirin? A. anti-inflammatory 1 B. antipyretic C. analgesic D. antihistaminic
D. antihistaminic
Both gingko biloba and ginseng contain A. dependence-producing ingredients 1 B. snake oil (serpentidic acid) C. opiates D. antioxidants
D. antioxidants
According to the text, what potential effect does aspirin have on pregnant women? A. increased risk of prolonged labor 2 B. increased risk of birth defects of the fetus C. increased risk of excessive bleeding during delivery D. both A and C
D. both A and C
When taking an antihistamine, the user should avoid A. driving a car 1 B. standing in the sun C. drinking alcohol D. both A and C
D. both A and C
A serious problem with acetaminophen is its potential to produce p.348 A. recurrent heart attacks 3 B. liver damage C. kidney damage D. both B and C
D. both B and C
Which of the following does NOT belong to a drug category that is FDA-regulated? A. analgesics 2 B. sleep-aids C. weight-loss aids D. dietary supplements
D. dietary supplements
It is important to make sure that the participants in Phase 2 drug trials are A. healthy volunteers 2 B. laboratory animals C. terminally ill D. free of health problems except for the condition the drug is intended to treat
D. free of health problems except for the condition the drug is intended to treat
Drugs designed for all but one of the following conditions have been approved using a streamlined FDA approval procedure? 3 A. Alzheimer's disease B. Parkinson's disease C. AIDS D. influenza
D. influenza
Drugs designed for all but one of the following conditions have been approved using a p.341 streamlined FDA approval procedure? 3 A. Alzheimer's disease B. Parkinson's disease C. AIDS D. influenza
D. influenza
From 2004 to 2008, the number of drugs that are very difficult to distinguish from each other _______ 2 A. reduced by 50 percent B. increased by 1000 percent C. increased by about 10 percent D. nearly doubled
D. nearly doubled
Prior to 1906, the only guarantee when purchasing a medicinal product was A. that it was unadulterated and pure 2 B. that it was honestly labeled C. both A and B D. neither A nor B
D. neither A nor B
As a result of the near-crisis regarding thalidomide, the federal government was given regulatory powers over the ________ of a new drug. 3 A. safety B. honest labeling C. number of refill prescriptions D. none of the above
D. none of the above
When taking OTC drugs, there are restrictions with regard to A. the disorder for which the drugs are taken 1 B. the dosage level that can be taken C. the number of refills that can be purchased D. none of the above
D. none of the above
The anticlotting effect of aspirin can be useful in the following circumstance: A. abdominal surgery 2 B. labor and childbirth C. hemophilia condition (inability for blood to clot) D. small clots in the brain or in coronary arteries
D. small clots in the brain or in coronary arteries
The association of acetaminophen and liver disease is increased when it is combined with A. acetylsalicylic acid 1 B. acetic acid C. alcohol D. aspirin
alcohol
The therapeutic applications of naproxen are similar to A. aspirin 2 B. acetaminophen C. Tylenol D. all of the above
aspirin
To widen blocked nasal passages and sinuses, one should choose an OTC drug with ________ properties. 1 A. antitussive B. expectorant C. decongestant D. antiopyretic
decongestant
Milk or food is advised to be taken with___________ to minimize gastric irritation. A. any prescription drug 2 B. ibuprofen C. alcohol D. acetaminophen
ibuprofen
Aleve is a brand name for A. acetaminophen 1 B. aspirin C. ibuprofen D. naproxen
naproxen
An example of the newest class of OTC analgesic drugs, discussed in the text, is A. acetaminophen 2 B. aspirin C. ibuprofen D. naproxen
naproxen
