Chapter 1-6: Basic Pharmacology for Nurses exam with
full solution 100% correct
Terms in this set (72)
Which use does the MedWatch form serve? 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 A drug may have multiple proprietary names.
is correct?
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 United States Pharmacopeia. Generic names are not
trademarked. Prescriptions can be written using generic or
trade names.
Which stage of new drug development Developmental stage—Phase 3
involves giving the medication to large
numbers of individuals with the disorder If phase 1 trials are successful, the drug is moved to phase
that the medication intends to treat? 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 description best defines a Drug used for a therapeutic effect to treat or prevent an
medication? 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.
, Which definition is accurate for the trade The proprietary name of the drug given by a manufacturer.
name of a drug?
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.
Which statement correctly describes the Schedule II drugs are more likely to cause dependence.
difference between Schedule II drugs and
Schedule V drugs? 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 The Federal Food, Drug, and Cosmetic Act of 1938
companies to determine the safety of
medications before marketing? 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.
full solution 100% correct
Terms in this set (72)
Which use does the MedWatch form serve? 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 A drug may have multiple proprietary names.
is correct?
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 United States Pharmacopeia. Generic names are not
trademarked. Prescriptions can be written using generic or
trade names.
Which stage of new drug development Developmental stage—Phase 3
involves giving the medication to large
numbers of individuals with the disorder If phase 1 trials are successful, the drug is moved to phase
that the medication intends to treat? 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 description best defines a Drug used for a therapeutic effect to treat or prevent an
medication? 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.
, Which definition is accurate for the trade The proprietary name of the drug given by a manufacturer.
name of a drug?
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.
Which statement correctly describes the Schedule II drugs are more likely to cause dependence.
difference between Schedule II drugs and
Schedule V drugs? 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 The Federal Food, Drug, and Cosmetic Act of 1938
companies to determine the safety of
medications before marketing? 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.
