UNITEK Pharmacology | Quiz 1 | Chapters 1,
2, 3. Questions and Correct Answers, With
Complete Solution. 100% Correct, 2024/5.
Which description best defines a medication?
A) Chemical substance that requires a prescription by a health professional
B) Drug used for a therapeutic effect to treat or prevent an illness
C) Pharmacologic preparation used to reverse disease
D) Plant, animal, or mineral substance that prevents disease
B) Drug used for a therapeutic effect to treat or prevent an illness
Medications are drugs used for their therapeutic effects. A therapeutic effect can be the prevention or
treatment of disease. All medications do not require a prescription. Specifying a certain action is not the
best definition of a medication because it is incomplete.
What is the trade name of a drug?
A) The proprietary name of the drug given by a manufacturer.
B) The chemical name of the drug given by its developer.
C) The name given to the drug by the U.S. Food and Drug Administration (FDA).
D) The name under which the drug is listed in the U.S. Pharmacopeia.
A) The proprietary name of the drug given by a manufacturer.
The trade or brand name is the proprietary name given to the drug by its manufacturer. The same drug
produced by different companies has one generic name but may have many trade names. The trade
name is trademark protected and can be used only by its manufacturer. The drug may be listed under
more than one name in the Pharmacopeia. The book is used to provide standards for identity, quality,
strength, and purity of substances used in healthcare practice. The trade name is not given to a drug by
the FDA. The chemical name is the exact chemical constitution of the drug and the exact placing of its
atoms or molecular groupings.
What is the MedWatch form used for?
A) Tracking numbers of prescriptions written for a specific drug
B) Assessing the acceptability of the drug to individual patients
C) Determining the therapeutic effectiveness of the drug
D) Identifying adverse effects of a drug in the general population
D) Identifying adverse effects of a drug in the general population
Healthcare practitioners make a significant contribution to the knowledge of drug safety by reporting
adverse effects to the FDA using the MedWatch program for the voluntary reporting of adverse events
and product problems. This method of identifying adverse effects of a drug in the general population is
part of the postmarketing surveillance phase of drug development. More than 200,000 MedWatch forms
are filed with the FDA annually. MedWatch is not designed to track the numbers of prescriptions written
for a specific drug; is not a program involved in determining the therapeutic effectiveness of a drug; and
is not involved in assessing the acceptability of a drug to individual patients.
,Which statement about drug names is correct?
A) Drugs are listed by their chemical names in the U.S. Pharmacopeia.
B) A drug may have multiple proprietary names.
C) The generic name is a trademarked name.
D) The official name must be used on all prescriptions.
B) A drug may have multiple proprietary names.
The proprietary name of a drug is a trade or brand name and is followed by the symbol ®. Each
manufacturer of a drug can register a proprietary name that can be used only by that company. Thus a
drug produced by more than one manufacturer can have multiple proprietary names but only one
generic name. Drugs are listed by their official names in the U.S. Pharmacopeia. Generic names are not
trademarked. Prescriptions can be written using generic or trade names.
How do Schedule II drugs differ from Schedule V drugs?
A) Schedule V drugs have greater risk for toxicity.
B) Schedule II drugs have less potential for abuse.
C) Schedule V drugs lack accepted safety measures for use.
D) Schedule II drugs are more likely to cause dependence.
D) Schedule II drugs are more likely to cause dependence.
Schedule II drugs have a high potential for abuse that may lead to severe psychological or physical
dependence. Schedule II drugs have more, not less, potential for abuse than Schedule V drugs. Schedule
II and Schedule V drugs have accepted guidelines for safe use. Drugs in both schedules are not
differentiated based on toxicity. There may be drugs in each schedule that have high or low toxicity.
Which legislation was written to require companies to determine the safety of medications before
marketing?
A) The Federal Food, Drug, and Cosmetic Act of 1938
B) Durham Humphrey Amendment of 1952
C) The Kefauver Harris Drug Amendment of 1962
D) Controlled Substance Act of 1970
A) The Federal Food, Drug, and Cosmetic Act of 1938
The Federal Food, Drug, and Cosmetic Act of 1938 (passed on June 25, 1938, and amended in 1952 and
1962) requires the FDA to determine the safety of drugs before marketing and to ensure that certain
labeling specifications and standards in advertising are met in the marketing of products. Manufacturers
are required to submit new drug applications to the FDA for review of safety studies before products can
be released. The Durham Humphrey Amendment of 1952 was passed to tighten control over
prescription drugs by restricting the refilling of prescriptions. The Kefauver Harris Drug Amendment of
1962 was brought about by the thalidomide tragedy. The amendment provides greater control and
surveillance of the distribution and clinical testing of investigational drugs, and requires that a product
be proven safe and effective before release for sale. The Controlled Substance Act of 1970 was passed by
Congress to improve the administration and regulation of manufacturing, distributing, and dispensing of
drugs that have been found necessary to be controlled.
Which legislation was enacted to stimulate development and availability of drugs to treat rare
diseases?
, A) The Orphan Drug Act
B) The Fast Tracking rules
C) The Controlled Drugs and Substance Act of 1997
D) The Food and Drug Act of 1979
A) The Orphan Drug Act
The medicines that are developed for rare conditions are known as orphan drugs, because the
manufacturers have been unable to recover the costs of the research due to the very limited use of the
final product. Because no companies were willing to "adopt" the disease to complete extensive research
to develop products for treatment, the diseases became known as health orphans. In 1983, Congress
passed the Orphan Drug Act to stimulate the development and market availability of products that are
used for the treatment of rare diseases. The Orphan Drug Act provides research grants, protocol
development assistance by the FDA, special tax credits for the cost of clinical trials, and 7 years of
exclusive marketing rights after the product has been approved. The Food and Drug Act of 1979
empowered Health Canada to protect the public from foreseeable risks relating to the manufacture and
sale of drugs. The Fast Tracking rules allow investigational drugs to receive highest priority for review
with the FDA. The Controlled Drugs and Substance Act of 1997 established the requirements for control
and sale of narcotics and substances of abuse in Canada.
Which stage of new drug development involves giving the medication to large numbers of individuals
with the disorder that the medication intends to treat?
A) Developmental stage—Phase 2
B) Postmarketing surveillance stage
C) Developmental stage—Phase 1
D) Developmental stage—Phase 3
D) Developmental stage—Phase 3
If phase 1 trials are successful, the drug is moved to phase 2, which involves a smaller population of
patients who have the condition that the drug is designed to treat. Studies at various dosages are
conducted to determine the success rate and safety of a drug for its intended use. If successful, the drug
is advanced to phase 3 trials, in which larger patient populations are used to ensure the statistical
significance of the results. Studies in this phase also provide additional information on proper dosing and
safety. Phase 1 studies are done to determine an experimental drug's pharmacologic properties, safe
dosage range, potential for toxicity at a certain dosage, and safe routes of administration. The study
population consists of either normal volunteers or the intended treatment population, such as those
patients who have failed standard treatments of certain cancers or dysrhythmias. Phase 2 studies usually
require 20 to 100 subjects, who are treated for 4 to 6 weeks. Studies in this phase are done to determine
the success rate of a drug for its intended use. After the manufacturer decides to market the medication,
there is ongoing review of adverse effects of the new drug, as well as periodic inspections of the
manufacturing facilities and products.
Which governmental body was organized to gather intelligence, train, conduct research in the area of
dangerous drugs and drug abuse, and enforce the Controlled Substances Act?
A) Central Intelligence Agency (CIA)
B) FDA
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