Class Notes for Pharmacology Connections to Nursing Practice, 2nd Edition
Class Notes for Pharmacology Connections to Nursing Practice, 2nd Edition simplifies complex topics with easy-to-understand notes.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
CHAPTER 1
INTRODUCTION TO PHARMACOLOGY: CONCEPTS AND CONNECTIONS
LEARNING OUTCOME 1
Identify key events in the history of pharmacology.
Concepts for Lecture
1. Over 3.6 billion prescriptions are dispensed each year in the United States, with the number rapidly
increasing.
2. Pharmacology has evolved over the centuries and is a key aspect of nursing care.
3. Pharmacology started with early man using plants and herbs to relieve disease symptoms.
4. One of the oldest forms of health care, herbal medicine has been practiced in virtually every culture
dating to antiquity.
5. Many early remedies were accidental discoveries.
6. First prescriptions written in the year 3,000 BC by the Babylonians. The Chinese have the first
recorded volume of plant remedies in the year 2,700 BC.
7. Pharmacology was probably reviewed as magic and superstition during the Dark Ages. There is very
little recorded data from the Dark Ages.
8. First began to be practiced as a science in the 17th century and the first text with the word
pharmacology was published in 1693.
9. In the 19th century, chemists were able to make remarkable progress in separating specific substances
and the first active agents such as morphine, colchicines, curare, cocaine, and other early drugs were
discovered from their natural plant products.
10. Early pharmacologists studied the effects on both animals as well as themselves.
11. First recognized as a discipline in Estonia in 1847. In the United States, the first pharmacology
department was at the University of Michigan in 1890.
12. The 20th century saw great progress and development of new drugs. We are now able to synthesize
drugs from “scratch” in the laboratory.
13. The current practice of pharmacology is complex, but the application has not changed. The goal of
pharmacology is to relieve human suffering.
LEARNING OUTCOME 2
Compare and contrast the terms drug, pharmacology, and pharmacotherapy.
Concepts for Lecture
1. The definition of a drug is difficult but important to the nurse.
CHAPTER 1
INTRODUCTION TO PHARMACOLOGY: CONCEPTS AND CONNECTIONS
LEARNING OUTCOME 1
Identify key events in the history of pharmacology.
Concepts for Lecture
1. Over 3.6 billion prescriptions are dispensed each year in the United States, with the number rapidly
increasing.
2. Pharmacology has evolved over the centuries and is a key aspect of nursing care.
3. Pharmacology started with early man using plants and herbs to relieve disease symptoms.
4. One of the oldest forms of health care, herbal medicine has been practiced in virtually every culture
dating to antiquity.
5. Many early remedies were accidental discoveries.
6. First prescriptions written in the year 3,000 BC by the Babylonians. The Chinese have the first
recorded volume of plant remedies in the year 2,700 BC.
7. Pharmacology was probably reviewed as magic and superstition during the Dark Ages. There is very
little recorded data from the Dark Ages.
8. First began to be practiced as a science in the 17th century and the first text with the word
pharmacology was published in 1693.
9. In the 19th century, chemists were able to make remarkable progress in separating specific substances
and the first active agents such as morphine, colchicines, curare, cocaine, and other early drugs were
discovered from their natural plant products.
10. Early pharmacologists studied the effects on both animals as well as themselves.
11. First recognized as a discipline in Estonia in 1847. In the United States, the first pharmacology
department was at the University of Michigan in 1890.
12. The 20th century saw great progress and development of new drugs. We are now able to synthesize
drugs from “scratch” in the laboratory.
13. The current practice of pharmacology is complex, but the application has not changed. The goal of
pharmacology is to relieve human suffering.
LEARNING OUTCOME 2
Compare and contrast the terms drug, pharmacology, and pharmacotherapy.
Concepts for Lecture
1. The definition of a drug is difficult but important to the nurse.
Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
CHAPTER 1
INTRODUCTION TO PHARMACOLOGY: CONCEPTS AND CONNECTIONS
LEARNING OUTCOME 1
Identify key events in the history of pharmacology.
Concepts for Lecture
1. Over 3.6 billion prescriptions are dispensed each year in the United States, with the number rapidly
increasing.
2. Pharmacology has evolved over the centuries and is a key aspect of nursing care.
3. Pharmacology started with early man using plants and herbs to relieve disease symptoms.
4. One of the oldest forms of health care, herbal medicine has been practiced in virtually every culture
dating to antiquity.
5. Many early remedies were accidental discoveries.
6. First prescriptions written in the year 3,000 BC by the Babylonians. The Chinese have the first
recorded volume of plant remedies in the year 2,700 BC.
7. Pharmacology was probably reviewed as magic and superstition during the Dark Ages. There is very
little recorded data from the Dark Ages.
8. First began to be practiced as a science in the 17th century and the first text with the word
pharmacology was published in 1693.
9. In the 19th century, chemists were able to make remarkable progress in separating specific substances
and the first active agents such as morphine, colchicines, curare, cocaine, and other early drugs were
discovered from their natural plant products.
10. Early pharmacologists studied the effects on both animals as well as themselves.
11. First recognized as a discipline in Estonia in 1847. In the United States, the first pharmacology
department was at the University of Michigan in 1890.
12. The 20th century saw great progress and development of new drugs. We are now able to synthesize
drugs from “scratch” in the laboratory.
13. The current practice of pharmacology is complex, but the application has not changed. The goal of
pharmacology is to relieve human suffering.
LEARNING OUTCOME 2
Compare and contrast the terms drug, pharmacology, and pharmacotherapy.
Concepts for Lecture
1. The definition of a drug is difficult but important to the nurse.
CHAPTER 1
INTRODUCTION TO PHARMACOLOGY: CONCEPTS AND CONNECTIONS
LEARNING OUTCOME 1
Identify key events in the history of pharmacology.
Concepts for Lecture
1. Over 3.6 billion prescriptions are dispensed each year in the United States, with the number rapidly
increasing.
2. Pharmacology has evolved over the centuries and is a key aspect of nursing care.
3. Pharmacology started with early man using plants and herbs to relieve disease symptoms.
4. One of the oldest forms of health care, herbal medicine has been practiced in virtually every culture
dating to antiquity.
5. Many early remedies were accidental discoveries.
6. First prescriptions written in the year 3,000 BC by the Babylonians. The Chinese have the first
recorded volume of plant remedies in the year 2,700 BC.
7. Pharmacology was probably reviewed as magic and superstition during the Dark Ages. There is very
little recorded data from the Dark Ages.
8. First began to be practiced as a science in the 17th century and the first text with the word
pharmacology was published in 1693.
9. In the 19th century, chemists were able to make remarkable progress in separating specific substances
and the first active agents such as morphine, colchicines, curare, cocaine, and other early drugs were
discovered from their natural plant products.
10. Early pharmacologists studied the effects on both animals as well as themselves.
11. First recognized as a discipline in Estonia in 1847. In the United States, the first pharmacology
department was at the University of Michigan in 1890.
12. The 20th century saw great progress and development of new drugs. We are now able to synthesize
drugs from “scratch” in the laboratory.
13. The current practice of pharmacology is complex, but the application has not changed. The goal of
pharmacology is to relieve human suffering.
LEARNING OUTCOME 2
Compare and contrast the terms drug, pharmacology, and pharmacotherapy.
Concepts for Lecture
1. The definition of a drug is difficult but important to the nurse.
Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
2. A drug is any substance that is taken to prevent, cure, or reduce symptoms of a medical condition.
3. Using examples discussed in text, discuss how water, vitamin C, cola, or natural hormones can be a
drug.
4. The word pharmacology came from the Greek pharmakon, which means “medicine” or “drugs” and
logos, which means “study.”
5. Pharmacotherapy or pharmacotherapeutics is the application of drugs for the purpose of disease
prevention and treatment.
6. The subject of pharmacology is an expansive subject that involves understanding what a drug is given
for, how it is administered, where it travels in the body, the actual response it produces, and how it is
eliminated.
7. Drugs are one form of medical intervention in which the nurse plays a major role.
a. The nurse designs interventions for desired health goals.
b. Pharmacotherapy is a critical intervention.
8. There are over 11,000 brand, generic, and combination agents, each with its own application,
interactions, side effects, and actions.
9. Many drugs have more than one use. They may be prescribed for more than one disease and many
produce multiple effects in the body.
10. Drug responses can differ in individual patients.
11. Patient factors that can cause drugs to elicit a different response are age, gender, race, body mass,
health status, and genetics.
12. New drugs are introduced each year.
13. Staying current and up-to-date with new drugs is critical for the patient and health care provider.
Proper application of a drug can improve quality of life while an improperly applied drug can cause
disability or even death.
LEARNING OUTCOME 3
Explain the importance of pharmacotherapy to clinical nursing practice.
Concepts for Lecture
1. Many people believe that there are perfect drugs and that the perfect drug should and can always be
selected for the patient.
2. Characteristics of the perfect or ideal drug:
a. Effective
b. Given at low doses
c. Works quickly
2. A drug is any substance that is taken to prevent, cure, or reduce symptoms of a medical condition.
3. Using examples discussed in text, discuss how water, vitamin C, cola, or natural hormones can be a
drug.
4. The word pharmacology came from the Greek pharmakon, which means “medicine” or “drugs” and
logos, which means “study.”
5. Pharmacotherapy or pharmacotherapeutics is the application of drugs for the purpose of disease
prevention and treatment.
6. The subject of pharmacology is an expansive subject that involves understanding what a drug is given
for, how it is administered, where it travels in the body, the actual response it produces, and how it is
eliminated.
7. Drugs are one form of medical intervention in which the nurse plays a major role.
a. The nurse designs interventions for desired health goals.
b. Pharmacotherapy is a critical intervention.
8. There are over 11,000 brand, generic, and combination agents, each with its own application,
interactions, side effects, and actions.
9. Many drugs have more than one use. They may be prescribed for more than one disease and many
produce multiple effects in the body.
10. Drug responses can differ in individual patients.
11. Patient factors that can cause drugs to elicit a different response are age, gender, race, body mass,
health status, and genetics.
12. New drugs are introduced each year.
13. Staying current and up-to-date with new drugs is critical for the patient and health care provider.
Proper application of a drug can improve quality of life while an improperly applied drug can cause
disability or even death.
LEARNING OUTCOME 3
Explain the importance of pharmacotherapy to clinical nursing practice.
Concepts for Lecture
1. Many people believe that there are perfect drugs and that the perfect drug should and can always be
selected for the patient.
2. Characteristics of the perfect or ideal drug:
a. Effective
b. Given at low doses
c. Works quickly
Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
d. No side effects
e. Convenient
f. Given once a day
g. Inexpensive
h. Easily eliminated
i. No interactions
3. There is no such thing as a perfect drug, but most prescription medications do have a degree of
effectiveness.
4. Conditions for which drugs are approved are called indications. All prescription drugs have at least
one indication and some have multiple indications.
5. Some drugs are used for conditions for which they do not have an approved indication; this is called
an unlabeled or off-label use.
6. Drugs that are used most often are ones that are close to the perfect drug profile. Drugs that have a
profile that strays furthest from the perfect drug profile are used infrequently.
7. Most drugs may be easily used at home by the patient, but some drugs may be only administered in
the clinical setting.
LEARNING OUTCOME 4
Using specific examples, explain the difference between the pharmacological and therapeutic methods of
classifying drugs.
Concepts for Lecture
1. Nurses need to understand how a drug works both therapeutically as well as pharmacologically.
2. Drug therapy is a large part of nursing care.
3. Understanding how patient variables affect drug therapy is a critical part of understanding drug
therapy.
4. Stay up-to-date on changes in drug indications as well as new drugs is part of ongoing nursing
education.
LEARNING OUTCOME 5
Identify the advantages of using prototype drugs to study pharmacology.
Concepts for Lecture
1. The Food and Drug Administration (FDA) publishes a document called the “Approved Therapeutic
Equivalence Evaluation,” which is also called the “Orange Book.” This document currently lists over
11,000 approved drugs. The list includes both prescription and nonprescription drugs.
d. No side effects
e. Convenient
f. Given once a day
g. Inexpensive
h. Easily eliminated
i. No interactions
3. There is no such thing as a perfect drug, but most prescription medications do have a degree of
effectiveness.
4. Conditions for which drugs are approved are called indications. All prescription drugs have at least
one indication and some have multiple indications.
5. Some drugs are used for conditions for which they do not have an approved indication; this is called
an unlabeled or off-label use.
6. Drugs that are used most often are ones that are close to the perfect drug profile. Drugs that have a
profile that strays furthest from the perfect drug profile are used infrequently.
7. Most drugs may be easily used at home by the patient, but some drugs may be only administered in
the clinical setting.
LEARNING OUTCOME 4
Using specific examples, explain the difference between the pharmacological and therapeutic methods of
classifying drugs.
Concepts for Lecture
1. Nurses need to understand how a drug works both therapeutically as well as pharmacologically.
2. Drug therapy is a large part of nursing care.
3. Understanding how patient variables affect drug therapy is a critical part of understanding drug
therapy.
4. Stay up-to-date on changes in drug indications as well as new drugs is part of ongoing nursing
education.
LEARNING OUTCOME 5
Identify the advantages of using prototype drugs to study pharmacology.
Concepts for Lecture
1. The Food and Drug Administration (FDA) publishes a document called the “Approved Therapeutic
Equivalence Evaluation,” which is also called the “Orange Book.” This document currently lists over
11,000 approved drugs. The list includes both prescription and nonprescription drugs.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
2. Drugs are categorized two ways: a therapeutic classification and a pharmacologic classification.
3. The therapeutic classification is how the drug is used in treating a specific disease; many drugs have
different types of therapeutic classes. The key to therapeutic classifications is which condition the
particular drug is treating. For example, one drug may lower blood pressure and also relieve chest
pain.
4. The pharmacological classification is the mechanism of drug action or how the drug produces its
effects in the body. Different drugs can all treat the same condition but they may do it differently.
This classification is considered more specific than the therapeutic classification. Again, many drugs
have multiple pharmacological classifications. The pharmacological classification may use the drug’s
chemical name.
5. Drugs may also have multiple therapeutic and pharmacological classifications that are dependent on
the clinical use of the drug; the student must understand all of these classifications.
LEARNING OUTCOME 6
Classify drugs by their chemical, generic, and trade names.
Concepts for Lecture
1. The prototype drug is usually the first and best understood drug in its class.
2. Sometimes the prototype may be a new or clinically more useful drug.
3. By learning the prototype drug, nurses can understand the depth, actions, and adverse effects of other
drugs in the same class.
4. Studying by prototype helps the nurse to understand a classification of drug therapy by studying a
single drug.
5. Prototypes are easily identified in the textbook, which gives the therapeutic effects, mechanism of
action, adverse effects, and nursing responsibilities for each prototype.
LEARNING OUTCOME 7
Compare the advantages and disadvantages of a pharmaceutical company being granted exclusivity for the
development of a new drug.
Concepts for Lecture
1. Drugs are identified by multiple names, which can be confusing to both the patient and health care
provider.
2. Chemical names are assigned by using standard nomenclature established by the International Union
of Pure and Applied Chemistry (IUPAC). Each drug has only one chemical name.
3. Drugs can be named and classified by a portion of their chemical structure, known as the chemical
group name.
4. Generic names are assigned by the U.S. Adopted Name Council. Generic names are usually less
complicated and are easier to remember than chemical names. Each drug has only one generic name.
2. Drugs are categorized two ways: a therapeutic classification and a pharmacologic classification.
3. The therapeutic classification is how the drug is used in treating a specific disease; many drugs have
different types of therapeutic classes. The key to therapeutic classifications is which condition the
particular drug is treating. For example, one drug may lower blood pressure and also relieve chest
pain.
4. The pharmacological classification is the mechanism of drug action or how the drug produces its
effects in the body. Different drugs can all treat the same condition but they may do it differently.
This classification is considered more specific than the therapeutic classification. Again, many drugs
have multiple pharmacological classifications. The pharmacological classification may use the drug’s
chemical name.
5. Drugs may also have multiple therapeutic and pharmacological classifications that are dependent on
the clinical use of the drug; the student must understand all of these classifications.
LEARNING OUTCOME 6
Classify drugs by their chemical, generic, and trade names.
Concepts for Lecture
1. The prototype drug is usually the first and best understood drug in its class.
2. Sometimes the prototype may be a new or clinically more useful drug.
3. By learning the prototype drug, nurses can understand the depth, actions, and adverse effects of other
drugs in the same class.
4. Studying by prototype helps the nurse to understand a classification of drug therapy by studying a
single drug.
5. Prototypes are easily identified in the textbook, which gives the therapeutic effects, mechanism of
action, adverse effects, and nursing responsibilities for each prototype.
LEARNING OUTCOME 7
Compare the advantages and disadvantages of a pharmaceutical company being granted exclusivity for the
development of a new drug.
Concepts for Lecture
1. Drugs are identified by multiple names, which can be confusing to both the patient and health care
provider.
2. Chemical names are assigned by using standard nomenclature established by the International Union
of Pure and Applied Chemistry (IUPAC). Each drug has only one chemical name.
3. Drugs can be named and classified by a portion of their chemical structure, known as the chemical
group name.
4. Generic names are assigned by the U.S. Adopted Name Council. Generic names are usually less
complicated and are easier to remember than chemical names. Each drug has only one generic name.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
5. Trade names are also called proprietary, product, or brand names. The trade name is assigned by the
pharmaceutical company.
6. Trades names are usually short and easy to remember.
7. The term proprietary suggests ownership and in the United States, the FDA grants the pharmaceutical
companies exclusive rights for naming and marketing a drug for a fixed number of years after the new
drug application is approved.
8. This process allows the drug company to recoup the cost of research and development of the drug.
9. When this patent expires, competing companies may sell a generic equivalent drug. They may give it
a different trade name, which the FDA must approve.
10. Trade names may be difficult to learn, because many products with different names may contain the
same drug.
11. Combination drugs are drugs with more than one active generic ingredient.
12. Because of the potential confusion with trade names, it is important that the nurse identifies drugs by
their trade names.
LEARNING OUTCOME 8
Analyze possible differences between generic drugs and their brand-name equivalents.
Concepts for Lecture
1. Pharmaceutical companies market their brand of drug. The exclusivity for marketing and selling the
drug under its trade name is limited for a certain period of time.
2. When this period of time or patent expires other companies may market the drug under its generic
name or create a new brand name for the drug.
3. Pharmaceutical companies often lobby aggressively against laws that might restrict the routine use of
certain brand name drugs. They claim that there is a difference between a trade name drug and its
generic equivalent and that switching to a generic may be harmful to the patient.
4. Consumer advocates argue that generic substitutions should always be permitted because they provide
cost savings to the patient.
5. Some states in the United States allow the pharmacist to routinely substitute a generic drug when the
prescription calls for a brand name drug. In other states, pharmacists must dispense as written or
obtain approval before providing a generic substitution. Many pharmacies provide lists of generic
drugs.
LEARNING OUTCOME 9
Assess the responsibilities of the nurse in drug administration.
Concepts for Lecture
1. Generic drugs may have identical doses, but their formulations or inert ingredients may differ.
5. Trade names are also called proprietary, product, or brand names. The trade name is assigned by the
pharmaceutical company.
6. Trades names are usually short and easy to remember.
7. The term proprietary suggests ownership and in the United States, the FDA grants the pharmaceutical
companies exclusive rights for naming and marketing a drug for a fixed number of years after the new
drug application is approved.
8. This process allows the drug company to recoup the cost of research and development of the drug.
9. When this patent expires, competing companies may sell a generic equivalent drug. They may give it
a different trade name, which the FDA must approve.
10. Trade names may be difficult to learn, because many products with different names may contain the
same drug.
11. Combination drugs are drugs with more than one active generic ingredient.
12. Because of the potential confusion with trade names, it is important that the nurse identifies drugs by
their trade names.
LEARNING OUTCOME 8
Analyze possible differences between generic drugs and their brand-name equivalents.
Concepts for Lecture
1. Pharmaceutical companies market their brand of drug. The exclusivity for marketing and selling the
drug under its trade name is limited for a certain period of time.
2. When this period of time or patent expires other companies may market the drug under its generic
name or create a new brand name for the drug.
3. Pharmaceutical companies often lobby aggressively against laws that might restrict the routine use of
certain brand name drugs. They claim that there is a difference between a trade name drug and its
generic equivalent and that switching to a generic may be harmful to the patient.
4. Consumer advocates argue that generic substitutions should always be permitted because they provide
cost savings to the patient.
5. Some states in the United States allow the pharmacist to routinely substitute a generic drug when the
prescription calls for a brand name drug. In other states, pharmacists must dispense as written or
obtain approval before providing a generic substitution. Many pharmacies provide lists of generic
drugs.
LEARNING OUTCOME 9
Assess the responsibilities of the nurse in drug administration.
Concepts for Lecture
1. Generic drugs may have identical doses, but their formulations or inert ingredients may differ.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
2. This difference may change the bioavailability of the drug.
3. Bioavailability is defined by the Federal Food, Drug, and Cosmetic Act (see Chapter 2), as the rate
and extent to which the active ingredient is absorbed from the drug product and then becomes
available at the site of the drug action to produce the desired effects.
4. Bioavailability may be affected by formulation, inert ingredients, and tablet compression. All of these
factors can affect the absorption and/or distribution of the drug.
5. Bioavailability is measured by the time it takes for the drug to exert its effect; it is also known as
onset time.
6. Bioavailability may differ between trade and generic drugs. This difference could be important with
drugs with critical care uses and those with a narrow safety margin. However, for most other drugs the
generic equivalent may be safely substituted.
7. Internet sites may allow patient to purchase drugs at substantial savings. However, the danger of this
is that the drugs may be sold from other countries and these countries may not have the same quality
control standards as the United States. These drugs may be harmful or not effective. The nurse must
help patients understand the differences and the potential dangers.
GENERAL CHAPTER CONSIDERATIONS
1. Have students study and learn key terms listed at beginning of chapter.
2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing
Student Resources website.
Marginal Notes
POWERPOINT SLIDES 5–12
SUGGESTION FOR CLASSROOM ACTIVITIES
• Make a time line with students to demonstrate how the science of pharmacology has had great progress
in the last two hundred years. Discuss what the future might hold.
REFERENCE
• The American Chemical Society website:
http://pubs.acs.org/subscribe/journals/mdd/v04/i05/html/05timeline.html
POWERPOINT SLIDES 13–18
Figure 1.1 Rationale for Pharmacotherapy
SUGGESTION FOR CLASSROOM ACTIVITIES
• Using the examples of water, vitamin C, and natural hormones, discuss how a patient may be confused
about the difference between a substance for everyday use or one that naturally occurs in the body, and
how these change when used in drug therapy.
POWERPOINT SLIDES 19–25
2. This difference may change the bioavailability of the drug.
3. Bioavailability is defined by the Federal Food, Drug, and Cosmetic Act (see Chapter 2), as the rate
and extent to which the active ingredient is absorbed from the drug product and then becomes
available at the site of the drug action to produce the desired effects.
4. Bioavailability may be affected by formulation, inert ingredients, and tablet compression. All of these
factors can affect the absorption and/or distribution of the drug.
5. Bioavailability is measured by the time it takes for the drug to exert its effect; it is also known as
onset time.
6. Bioavailability may differ between trade and generic drugs. This difference could be important with
drugs with critical care uses and those with a narrow safety margin. However, for most other drugs the
generic equivalent may be safely substituted.
7. Internet sites may allow patient to purchase drugs at substantial savings. However, the danger of this
is that the drugs may be sold from other countries and these countries may not have the same quality
control standards as the United States. These drugs may be harmful or not effective. The nurse must
help patients understand the differences and the potential dangers.
GENERAL CHAPTER CONSIDERATIONS
1. Have students study and learn key terms listed at beginning of chapter.
2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing
Student Resources website.
Marginal Notes
POWERPOINT SLIDES 5–12
SUGGESTION FOR CLASSROOM ACTIVITIES
• Make a time line with students to demonstrate how the science of pharmacology has had great progress
in the last two hundred years. Discuss what the future might hold.
REFERENCE
• The American Chemical Society website:
http://pubs.acs.org/subscribe/journals/mdd/v04/i05/html/05timeline.html
POWERPOINT SLIDES 13–18
Figure 1.1 Rationale for Pharmacotherapy
SUGGESTION FOR CLASSROOM ACTIVITIES
• Using the examples of water, vitamin C, and natural hormones, discuss how a patient may be confused
about the difference between a substance for everyday use or one that naturally occurs in the body, and
how these change when used in drug therapy.
POWERPOINT SLIDES 19–25
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students look at current media marketing for prescription drugs—television, print, and radio are
suggestions. Discuss what parts of the ad attempt to make the drug appear to be the “perfect” drug for
that condition.
POWERPOINT SLIDE 26
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Have students discuss various ways of finding up-to-date drug therapy information. Suggestions
include reference books, evidence-based Internet sites, ongoing clinical education, and pharmacists.
• Suggested sources include the drug information handbook assigned for the course, plus the following
websites:
www.ptcommunity.com
www.nlm.nih.gov/medlineplus/druginformation.html
www.drugs.com
POWERPOINT SLIDES 26–33
Table 1.1 Therapeutic Classifications
Table 1.2 Pharmacologic Classification
SUGGESTION FOR CLASSROOM ACTIVITIES
• Go to the FDA Orange Book website: http://www.fda.gov/cder/ob/. Engage students in using the
website to search for various drugs. Use the FAQ link to demonstrate how to stay updated on new
drugs.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the students compare and contrast medication therapy used for patients who have the same
disease state, but are being treated with different drugs. Compare the drug’s pharmacological and
therapeutic classifications.
POWERPOINT SLIDES 34–35
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have the students use the textbook to locate a prototype drug. Discuss how it is easily identifiable and
what important nursing considerations are listed for each prototype.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students look at a medication administration record for an assigned patient. Compare which drugs
are prototypes and which are not. Students could also discuss how different or similar the drug is to the
prototype.
POWERPOINT SLIDES 36–42
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students look at current media marketing for prescription drugs—television, print, and radio are
suggestions. Discuss what parts of the ad attempt to make the drug appear to be the “perfect” drug for
that condition.
POWERPOINT SLIDE 26
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Have students discuss various ways of finding up-to-date drug therapy information. Suggestions
include reference books, evidence-based Internet sites, ongoing clinical education, and pharmacists.
• Suggested sources include the drug information handbook assigned for the course, plus the following
websites:
www.ptcommunity.com
www.nlm.nih.gov/medlineplus/druginformation.html
www.drugs.com
POWERPOINT SLIDES 26–33
Table 1.1 Therapeutic Classifications
Table 1.2 Pharmacologic Classification
SUGGESTION FOR CLASSROOM ACTIVITIES
• Go to the FDA Orange Book website: http://www.fda.gov/cder/ob/. Engage students in using the
website to search for various drugs. Use the FAQ link to demonstrate how to stay updated on new
drugs.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the students compare and contrast medication therapy used for patients who have the same
disease state, but are being treated with different drugs. Compare the drug’s pharmacological and
therapeutic classifications.
POWERPOINT SLIDES 34–35
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have the students use the textbook to locate a prototype drug. Discuss how it is easily identifiable and
what important nursing considerations are listed for each prototype.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students look at a medication administration record for an assigned patient. Compare which drugs
are prototypes and which are not. Students could also discuss how different or similar the drug is to the
prototype.
POWERPOINT SLIDES 36–42
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
Table 1.3 Brand Names
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students look at popular generics such as acetaminophen, aspirin, or ibuprofen. Have them
identify possible trade names that are popular for these drugs. Then look at which products may
represent a combination of drugs.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students take a drug history from a patient. Discuss if the patients identify their medications by
generic or trade names. Have students discuss how this could lead to possible medication errors.
SUGGESTION FOR CLASSROOM ACTIVITIES
• Using Internet pharmacy sites, compare and contrast the differences between prices for trade and
generic drugs. Example sites include: http://www.pharmacychecker.com/
http://www.drugstore.com
http://drx.com
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the students interview a hospital or neighbor pharmacist to find out what the law in their state is
regarding substitution of generic drugs.
POWERPOINT SLIDES 43-48
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Give examples of drugs that may be available to the patient in both trade and generic names.
Suggestions could be ibuprofen, loratadine, and pseudoephedrine. Discuss what could change the
bioavailability of the drug.
• Have the student role-play a scene where a patient asks the nurse if generic substitutions are safe, and
how the nurse would respond. Role-play another scene where the patient asks the nurse about using an
overseas Internet pharmacy.
POWERPOINT SLIDES 49–52
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• The students should take the core responsibilities for safe drug administration and discuss how each
concept can prevent medication errors.
• Have the students work in small groups and interview each other. Have them identify differences in
their own demographics that would influence safe drug therapy.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the student shadow a nurse in the hospital or clinic setting who is assigned to administer
medications. Have the student observe how the nurse checks to make sure the medications are correct
for that patient, if the drugs are dispensed in trade or generic names, what checks the nurse completes
Table 1.3 Brand Names
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students look at popular generics such as acetaminophen, aspirin, or ibuprofen. Have them
identify possible trade names that are popular for these drugs. Then look at which products may
represent a combination of drugs.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students take a drug history from a patient. Discuss if the patients identify their medications by
generic or trade names. Have students discuss how this could lead to possible medication errors.
SUGGESTION FOR CLASSROOM ACTIVITIES
• Using Internet pharmacy sites, compare and contrast the differences between prices for trade and
generic drugs. Example sites include: http://www.pharmacychecker.com/
http://www.drugstore.com
http://drx.com
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the students interview a hospital or neighbor pharmacist to find out what the law in their state is
regarding substitution of generic drugs.
POWERPOINT SLIDES 43-48
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Give examples of drugs that may be available to the patient in both trade and generic names.
Suggestions could be ibuprofen, loratadine, and pseudoephedrine. Discuss what could change the
bioavailability of the drug.
• Have the student role-play a scene where a patient asks the nurse if generic substitutions are safe, and
how the nurse would respond. Role-play another scene where the patient asks the nurse about using an
overseas Internet pharmacy.
POWERPOINT SLIDES 49–52
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• The students should take the core responsibilities for safe drug administration and discuss how each
concept can prevent medication errors.
• Have the students work in small groups and interview each other. Have them identify differences in
their own demographics that would influence safe drug therapy.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the student shadow a nurse in the hospital or clinic setting who is assigned to administer
medications. Have the student observe how the nurse checks to make sure the medications are correct
for that patient, if the drugs are dispensed in trade or generic names, what checks the nurse completes
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
before dispensing the medication, and what teaching the nurse offers the patient about the medication.
PEARSON NURSING STUDENT RESOURCES (WWW.NURSING.PEARSONHIGHERED.COM)
• WebLinks
• NCLEX®-style review questions
• Case studies
• Making the Patient Connection
• Mechanism of Action Animations
MYNURSINGLAB (WWW.MYNURSINGLAB.COM)
• Knowledge Quick Check
• Pre/Posttests
• Customized study plans
• Separate purchase
PRENTICE HALL NURSE’S DRUG GUIDE
• Separate purchase
PEARSON E TEXT
• Students can search, highlight, take notes, and more all in electronic format.
• Separate purchase
MYTEST
before dispensing the medication, and what teaching the nurse offers the patient about the medication.
PEARSON NURSING STUDENT RESOURCES (WWW.NURSING.PEARSONHIGHERED.COM)
• WebLinks
• NCLEX®-style review questions
• Case studies
• Making the Patient Connection
• Mechanism of Action Animations
MYNURSINGLAB (WWW.MYNURSINGLAB.COM)
• Knowledge Quick Check
• Pre/Posttests
• Customized study plans
• Separate purchase
PRENTICE HALL NURSE’S DRUG GUIDE
• Separate purchase
PEARSON E TEXT
• Students can search, highlight, take notes, and more all in electronic format.
• Separate purchase
MYTEST
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
CHAPTER2
DRUG REGULATIONS
LEARNING OUTCOME 1
Explain the role of patent medicines in the history of pharmacology and the legislation of drugs.
Concepts for Lecture
1. In the United States and Canada laws govern all aspects of drug approval, labelling, manufacturing,
marketing, and distribution.
2. Consumers expect that the drug they are taking is effective and that the label is clear and accurate.
3. Consumers expect that the drug they are taking is safe.
4. It is only since the 20th century that standards and regulations exist to protect the consumer.
5. In early America, patent medicine was widely used and available.
6. There were no laws to regulate these medicines and products could make any claim to health or cure.
7. Many patent medicines contain addictive and at times dangerous additives, such as morphine and
cocaine. Such addictive additives guaranteed repeat sales.
8. Several early patent medicines have gone through drug regulation and change and are still available
today.
LEARNING OUTCOME 2
Outline the key U.S. drug regulations and explain how each has contributed to the safety and effectiveness
of the medications.
Concepts for Lecture
1. Drug legislation began in the 1900s to make drugs safer and more effective.
2. The first national law was the Drug Importation Act passed in 1848.
3. This was spurred on deaths of children in 1901 who were given a contaminated antitoxin.
4. The Biologics Control Act was passed in 1902 to regulate era, antitoxins, and blood-related products.
5. The Pure Food and Drug Act (PFDA) was passed in 1906 to control labelling of medicines.
6. The PFDA required accuracy in drug labeling.
7. In 1912 the Sherley Amendment to the PFDA addresses false therapeutic claims on drug labels.
8. The Sherley Amendment did not address the issue of proving that the drug company knew that their
false claim was intentional.
9. The Harrison Narcotic Act of 1914 required prescriptions for higher doses of narcotic drugs.
CHAPTER2
DRUG REGULATIONS
LEARNING OUTCOME 1
Explain the role of patent medicines in the history of pharmacology and the legislation of drugs.
Concepts for Lecture
1. In the United States and Canada laws govern all aspects of drug approval, labelling, manufacturing,
marketing, and distribution.
2. Consumers expect that the drug they are taking is effective and that the label is clear and accurate.
3. Consumers expect that the drug they are taking is safe.
4. It is only since the 20th century that standards and regulations exist to protect the consumer.
5. In early America, patent medicine was widely used and available.
6. There were no laws to regulate these medicines and products could make any claim to health or cure.
7. Many patent medicines contain addictive and at times dangerous additives, such as morphine and
cocaine. Such addictive additives guaranteed repeat sales.
8. Several early patent medicines have gone through drug regulation and change and are still available
today.
LEARNING OUTCOME 2
Outline the key U.S. drug regulations and explain how each has contributed to the safety and effectiveness
of the medications.
Concepts for Lecture
1. Drug legislation began in the 1900s to make drugs safer and more effective.
2. The first national law was the Drug Importation Act passed in 1848.
3. This was spurred on deaths of children in 1901 who were given a contaminated antitoxin.
4. The Biologics Control Act was passed in 1902 to regulate era, antitoxins, and blood-related products.
5. The Pure Food and Drug Act (PFDA) was passed in 1906 to control labelling of medicines.
6. The PFDA required accuracy in drug labeling.
7. In 1912 the Sherley Amendment to the PFDA addresses false therapeutic claims on drug labels.
8. The Sherley Amendment did not address the issue of proving that the drug company knew that their
false claim was intentional.
9. The Harrison Narcotic Act of 1914 required prescriptions for higher doses of narcotic drugs.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
10. States and the federal government have passed additional laws regulating drugs of abuse. This is
covered in Chapter 8.
11. Two issues with early regulations were that the drug companies did not have to prove that the drug
was effective and did not require testing before marketing.
12. After deaths in 1937 due to a contaminated drug, the Food, Drug, and Cosmetic Act (FDCA) was
passed by Congress in 1938.
13. The FDCA required that drugs be tested for safety before marketing and drug labels to contain
instructions for use.
14. The FDCA did not define what was considered a prescription drug.
15. In 1951 the Durham-Humphrey Amendment to the FDCA defined the difference between prescription
drugs and over-the-counter (OTC) drugs.
16. In the late 1950s, there was a high number of birth defects from the drug thalidomide, which was
prescribed to pregnant women by their physicians. Because these physicians received the drug from
the manufacturer with FDA approval, the Kefauver-Harris Amendment to the FDCA was passed in
1962.
17. The Kefauver-Harris Amendment required that manufacturers prove their drugs safe and effective by
conduction of adequate and controlled studies.
18. The Kefauver-Harris Amendment also required adverse effects be reported to the FDA and included
in literature given to health care providers.
19. The Kefauver-Harris Amendment also required informed consent of those patients participating in
drug research.
20. In 1966, the FDA began evaluating the effectiveness of previously approved drugs.
21. In, 1972 the FDA began reviewing over-the-counter drugs for safety and effectiveness.
22. In 1983, the Orphan Drug Act became law to assist with development of drugs for serious, but rare,
diseases.
23. The Prescription Drug User Fee Act (PDUFA) of 1992 assessed fees from manufacturers to reduce
drug review time.
24. The 1997 passage of the Food and Drug Administration Modernization Act reviewed medical devices
and health claims for food.
25. The Dietary Supplement Health and Education Act of 1994 aimed to control claims of dietary
supplements.
26. The Medicare Prescription Drug Improvement and Modernization Act of 2003 aimed to assist
patients with prescription drug costs.
LEARNING OUTCOME 3
Describe how the United States Pharmacopeia-National Formulary (USP-NF) controls drug purity and
standards.
10. States and the federal government have passed additional laws regulating drugs of abuse. This is
covered in Chapter 8.
11. Two issues with early regulations were that the drug companies did not have to prove that the drug
was effective and did not require testing before marketing.
12. After deaths in 1937 due to a contaminated drug, the Food, Drug, and Cosmetic Act (FDCA) was
passed by Congress in 1938.
13. The FDCA required that drugs be tested for safety before marketing and drug labels to contain
instructions for use.
14. The FDCA did not define what was considered a prescription drug.
15. In 1951 the Durham-Humphrey Amendment to the FDCA defined the difference between prescription
drugs and over-the-counter (OTC) drugs.
16. In the late 1950s, there was a high number of birth defects from the drug thalidomide, which was
prescribed to pregnant women by their physicians. Because these physicians received the drug from
the manufacturer with FDA approval, the Kefauver-Harris Amendment to the FDCA was passed in
1962.
17. The Kefauver-Harris Amendment required that manufacturers prove their drugs safe and effective by
conduction of adequate and controlled studies.
18. The Kefauver-Harris Amendment also required adverse effects be reported to the FDA and included
in literature given to health care providers.
19. The Kefauver-Harris Amendment also required informed consent of those patients participating in
drug research.
20. In 1966, the FDA began evaluating the effectiveness of previously approved drugs.
21. In, 1972 the FDA began reviewing over-the-counter drugs for safety and effectiveness.
22. In 1983, the Orphan Drug Act became law to assist with development of drugs for serious, but rare,
diseases.
23. The Prescription Drug User Fee Act (PDUFA) of 1992 assessed fees from manufacturers to reduce
drug review time.
24. The 1997 passage of the Food and Drug Administration Modernization Act reviewed medical devices
and health claims for food.
25. The Dietary Supplement Health and Education Act of 1994 aimed to control claims of dietary
supplements.
26. The Medicare Prescription Drug Improvement and Modernization Act of 2003 aimed to assist
patients with prescription drug costs.
LEARNING OUTCOME 3
Describe how the United States Pharmacopeia-National Formulary (USP-NF) controls drug purity and
standards.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
Concepts for Lecture
1. When drugs were prepared from plants, purity and strength varied due to the ingredients and preparer.
2. Pharmacists began using formularies to list products and recipes.
3. In 1820 the U.S. Pharmacopeia (USP) was established.
4. For over 100 years, the USP and the National Formulary (NF) maintained drug standards in the
United States by setting standards for drug purity and strength.
5. The USP covered drug products and the NF covered nondrug ingredients.
6. In 1975 they were merged into the USP-NF, which is published annually.
7. The USP label is found on many medications.
8. Drugs marketed in the United States must conform to USP-NF standards.
LEARNING OUTCOME 4
Evaluate the role of the U.S. Food and Drug Administration in the drug approval process.
Concepts for Lecture
1. The Food and Drug Administration (FDA) is responsible for ensuring the safety of drugs and medical
devices.
2. The FDA started in 1906, making it the oldest drug regulatory agency in the world. It has eight
branches.
3. The Center for Drug Evaluation and Research (CDER) covers drug safety.
4. The Center for Biologics Evaluation and Research (CBER) regulates biologic safety.
5. The Center for Food Safety and Applied Nutrition (CFSAN) over sees herbal products, dietary
supplements, and cosmetics, but does not require testing of herbals and dietary supplements before
marketing.
6. CFSAN regulates cosmetics that are not considered drugs.
LEARNING OUTCOME 5
Categorize the four stages of new drug approval.
Concepts for Lecture
1. The drug approval process in the United States was established by the FDA.
2. The drug approval process ensures drugs sold in the United States are safe and effective.
3. There are four stages to new drug approval.
4. The first stage is preclinical investigational. This is laboratory research by the pharmaceutical
Concepts for Lecture
1. When drugs were prepared from plants, purity and strength varied due to the ingredients and preparer.
2. Pharmacists began using formularies to list products and recipes.
3. In 1820 the U.S. Pharmacopeia (USP) was established.
4. For over 100 years, the USP and the National Formulary (NF) maintained drug standards in the
United States by setting standards for drug purity and strength.
5. The USP covered drug products and the NF covered nondrug ingredients.
6. In 1975 they were merged into the USP-NF, which is published annually.
7. The USP label is found on many medications.
8. Drugs marketed in the United States must conform to USP-NF standards.
LEARNING OUTCOME 4
Evaluate the role of the U.S. Food and Drug Administration in the drug approval process.
Concepts for Lecture
1. The Food and Drug Administration (FDA) is responsible for ensuring the safety of drugs and medical
devices.
2. The FDA started in 1906, making it the oldest drug regulatory agency in the world. It has eight
branches.
3. The Center for Drug Evaluation and Research (CDER) covers drug safety.
4. The Center for Biologics Evaluation and Research (CBER) regulates biologic safety.
5. The Center for Food Safety and Applied Nutrition (CFSAN) over sees herbal products, dietary
supplements, and cosmetics, but does not require testing of herbals and dietary supplements before
marketing.
6. CFSAN regulates cosmetics that are not considered drugs.
LEARNING OUTCOME 5
Categorize the four stages of new drug approval.
Concepts for Lecture
1. The drug approval process in the United States was established by the FDA.
2. The drug approval process ensures drugs sold in the United States are safe and effective.
3. There are four stages to new drug approval.
4. The first stage is preclinical investigational. This is laboratory research by the pharmaceutical
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
company.
5. The FDA does not regulate the preclinical investigation.
6. If the preclinical investigation is positive, the company may submit an Investigational New Drug
(IND) application to the FDA.
7. Once approved by the FDA, the drug can start clinical phase trials.
8. Phase 1 involves testing on 20 to 80 healthy volunteers.
9. Phase 2 involves testing several hundred patients with the particular disease for the drug.
10. Phase 3 involves a large number of patients with the disease for patient variability.
11. If the clinical phase trials are positive, the company will submit a New Drug Application (NDA) to
the FDA.
12. The FDA will then approve or not approve a drug.
13. If approved, the drug can begin post marketing surveillance, which is stage 4.
14. Stage 4 looks for harmful drug effects in a large population.
15. Post marketing surveillance helps the FDA discover any serious problems. The Adverse Event
Reporting System and FDA public meetings allow patients and health care providers to report
problems.
16. Although more diverse populations are used to test drugs, most drugs are not tested in children and
pregnant women, as these populations are not used in drug testing.
17. Off-label use is when a drug is discovered to be useful for an indication that was not approved by the
FDA.
18. The FDA does not regulate off-label use. About 20% of prescription drugs are used off-label.
LEARNING OUTCOME 6
Explain the role of a placebo in new drug testing.
Concepts for Lecture
1. A placebo or inert substance is used in phase 2 of clinical drug trials.
2. The placebo serves as a control or nontreatment group.
LEARNING OUTCOME 7
Discuss how recent changes to the approval process have increased the speed at which new drugs reach
consumers.
Concepts for Lecture
1. The process of developing and testing a new drug can take many years.
company.
5. The FDA does not regulate the preclinical investigation.
6. If the preclinical investigation is positive, the company may submit an Investigational New Drug
(IND) application to the FDA.
7. Once approved by the FDA, the drug can start clinical phase trials.
8. Phase 1 involves testing on 20 to 80 healthy volunteers.
9. Phase 2 involves testing several hundred patients with the particular disease for the drug.
10. Phase 3 involves a large number of patients with the disease for patient variability.
11. If the clinical phase trials are positive, the company will submit a New Drug Application (NDA) to
the FDA.
12. The FDA will then approve or not approve a drug.
13. If approved, the drug can begin post marketing surveillance, which is stage 4.
14. Stage 4 looks for harmful drug effects in a large population.
15. Post marketing surveillance helps the FDA discover any serious problems. The Adverse Event
Reporting System and FDA public meetings allow patients and health care providers to report
problems.
16. Although more diverse populations are used to test drugs, most drugs are not tested in children and
pregnant women, as these populations are not used in drug testing.
17. Off-label use is when a drug is discovered to be useful for an indication that was not approved by the
FDA.
18. The FDA does not regulate off-label use. About 20% of prescription drugs are used off-label.
LEARNING OUTCOME 6
Explain the role of a placebo in new drug testing.
Concepts for Lecture
1. A placebo or inert substance is used in phase 2 of clinical drug trials.
2. The placebo serves as a control or nontreatment group.
LEARNING OUTCOME 7
Discuss how recent changes to the approval process have increased the speed at which new drugs reach
consumers.
Concepts for Lecture
1. The process of developing and testing a new drug can take many years.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
2. The FDA review process can take several years.
3. The estimated cost to bring a new drug to market can be over $802 million U.S. dollars.
4. Pharmaceutical companies are anxious to recoup the high expenses.
5. The public is also anxious for new medications, especially for diseases with a high mortality rate.
6. In 1992 the PDUFA was passed, which provided yearly product user fees.
7. This income allowed the FDA to restructure and hire more employees.
8. This restructuring decreased their view process by half.
9. Priority drugs now receive accelerated approval.
10. These priority drugs are for serious and life-threatening conditions.
LEARNING OUTCOME 8
Compare and contrast prescription and over-the-counter drugs.
Concepts for Lecture
1. The Durham-Humphrey Amendment of 1951 established the difference between prescriptions and
over-the-counter (OTC) drugs.
2. A patient must have authorization, a “prescription” to receive a prescription drug.
3. Prescription drugs are considered to be potentially addictive or too harmful for self-administration.
Prescription drugs require skill to administer correctly.
4. Prescription drugs allow the patient to be examined and properly diagnosed.
5. Prescription drugs allow for patient teaching and disease monitoring. Prescription drugs treat complex
conditions.
6. OTC drugs do not require a prescription for a health care provider.
7. OTC drugs are safe if the patient carefully follows the instructions.
8. OTC drugs are easier to obtain.
9. Choosing the correct OTC drug can be a problem for the patient.
10. Patients may not be aware of food, drug, and herbal interactions with OTC drugs.
11. Self-treatment with OTC drugs can be ineffective.
12. Prescription drugs can undergo a review process by the FDA which can reclassify a prescription drug
to be an OTC drug. In order for a prescription drug to be reclassified as an OTC drug, a high margin
of safety must exist.
13. Herbal and dietary supplements are available over the counter.
2. The FDA review process can take several years.
3. The estimated cost to bring a new drug to market can be over $802 million U.S. dollars.
4. Pharmaceutical companies are anxious to recoup the high expenses.
5. The public is also anxious for new medications, especially for diseases with a high mortality rate.
6. In 1992 the PDUFA was passed, which provided yearly product user fees.
7. This income allowed the FDA to restructure and hire more employees.
8. This restructuring decreased their view process by half.
9. Priority drugs now receive accelerated approval.
10. These priority drugs are for serious and life-threatening conditions.
LEARNING OUTCOME 8
Compare and contrast prescription and over-the-counter drugs.
Concepts for Lecture
1. The Durham-Humphrey Amendment of 1951 established the difference between prescriptions and
over-the-counter (OTC) drugs.
2. A patient must have authorization, a “prescription” to receive a prescription drug.
3. Prescription drugs are considered to be potentially addictive or too harmful for self-administration.
Prescription drugs require skill to administer correctly.
4. Prescription drugs allow the patient to be examined and properly diagnosed.
5. Prescription drugs allow for patient teaching and disease monitoring. Prescription drugs treat complex
conditions.
6. OTC drugs do not require a prescription for a health care provider.
7. OTC drugs are safe if the patient carefully follows the instructions.
8. OTC drugs are easier to obtain.
9. Choosing the correct OTC drug can be a problem for the patient.
10. Patients may not be aware of food, drug, and herbal interactions with OTC drugs.
11. Self-treatment with OTC drugs can be ineffective.
12. Prescription drugs can undergo a review process by the FDA which can reclassify a prescription drug
to be an OTC drug. In order for a prescription drug to be reclassified as an OTC drug, a high margin
of safety must exist.
13. Herbal and dietary supplements are available over the counter.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
14. Herbal and dietary supplements are not considered drugs. They are not subjected to the same
regulatory process as prescription drugs.
15. The FDA does not test herbal and dietary supplements for safety. These products can cause side
effects and interact with medications.
LEARNING OUTCOME 9
Explain how scheduled drugs are classified and regulated.
Concepts for Lecture
1. Some drugs have a high potential for dependence.
2. Some drugs are frequently abused.
3. The sale and distribution of these drugs are highly restricted.
4. Drugs with a high potential for abuse are called scheduled drugs.
5. These drugs are placed into one of five categories called schedules.
6. Dependencies and drug schedules are discussed in Chapter 8.
7. The Comprehensive Drug Abuse Prevention and Control Act of 1970 restricts these controlled
substances.
8. The Drug Enforcement Administration (DEA) requires hospitals and pharmacies to use registration
numbers to purchase these drugs.
9. Complete records must be maintained of qualities purchased and sold.
10. Drugs with the highest abuse potential have additional restrictions.
11. These restrictions may include special order forms, no telephone orders, and no refills.
12. There are strict penalties for not following the laws.
LEARNING OUTCOME 10
Describe the Canadian drug approval process and identify similarities to the drug approval process in the
United States.
Concepts for Lecture
1. There are many similarities between U.S. and Canadian regulations for drugs.
2. Health Canada is the federal department and the Health Products and Food Branch (HPFB) of Health
Canada is the regulatory body for health products and food safety.
3. The HPFB regulates the use of therapeutic products by directorates.
4. The Therapeutic Products Directorate (TPD) authorizes marketing of drugs and medical devices.
5. The Biologics and Genetic Therapies Directorate (BGTD) regulate biological drugs and radio
14. Herbal and dietary supplements are not considered drugs. They are not subjected to the same
regulatory process as prescription drugs.
15. The FDA does not test herbal and dietary supplements for safety. These products can cause side
effects and interact with medications.
LEARNING OUTCOME 9
Explain how scheduled drugs are classified and regulated.
Concepts for Lecture
1. Some drugs have a high potential for dependence.
2. Some drugs are frequently abused.
3. The sale and distribution of these drugs are highly restricted.
4. Drugs with a high potential for abuse are called scheduled drugs.
5. These drugs are placed into one of five categories called schedules.
6. Dependencies and drug schedules are discussed in Chapter 8.
7. The Comprehensive Drug Abuse Prevention and Control Act of 1970 restricts these controlled
substances.
8. The Drug Enforcement Administration (DEA) requires hospitals and pharmacies to use registration
numbers to purchase these drugs.
9. Complete records must be maintained of qualities purchased and sold.
10. Drugs with the highest abuse potential have additional restrictions.
11. These restrictions may include special order forms, no telephone orders, and no refills.
12. There are strict penalties for not following the laws.
LEARNING OUTCOME 10
Describe the Canadian drug approval process and identify similarities to the drug approval process in the
United States.
Concepts for Lecture
1. There are many similarities between U.S. and Canadian regulations for drugs.
2. Health Canada is the federal department and the Health Products and Food Branch (HPFB) of Health
Canada is the regulatory body for health products and food safety.
3. The HPFB regulates the use of therapeutic products by directorates.
4. The Therapeutic Products Directorate (TPD) authorizes marketing of drugs and medical devices.
5. The Biologics and Genetic Therapies Directorate (BGTD) regulate biological drugs and radio
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
pharmaceuticals.
6. The Natural Health Products Directorate (NHPD) regulates natural products.
7. The Canadian Food and Drugs Acts is a regulatory document that specifies that drugs cannot be
marketed without a Notice of Compliance (NOC) and Drug Identification Number (DIN) from Health
Canada.
8. If a drug does not comply with standards set in the United States, Europe, Britain, or France, they
cannot be sold, labeled, packaged, or sold in Canada.
GENERAL CHAPTER CONSIDERATIONS
1. Have students study and learn key terms listed at beginning of chapter.
2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing
Student Resources website.
Marginal Notes
POWER POINT SLIDES 6–11
Figure 2.1 Patent Medicines Contained a Name Brand That Clearly Identified the Product and Claimed to
Cure Just about Any Symptom or Disease
Figure 2.1 Patent Medicines
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss with students how patent medicines have “survived” over along period of time. Use examples
given in the textbook such as Smith Cough Drops, Fletcher’s Castoria, Doan’s Pills, Vick’s Vapo Rub,
and Phillip’s Milk of Magnesia. Why are these products still popular and widely used? What could be
some of the reasons that they survived regulations?
POWERPOINT SLIDES 12–18
Table 2.1 Historical Time Line of Regulatory Acts, Standards, and Organization
Figure 2.2 USP Labels
SUGGESTION FOR CLASSROOM ACTIVITIES
• Using the time line in Table 2.1, have the students add any future regulations they believe are needed
or forthcoming.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students teach assigned patients in the clinical setting what U.S. regulations ensure the safety and
effectiveness of their drug therapy.
POWERPOINT SLIDES 19-20
SUGGESTION FOR CLASSROOM ACTIVITIES
pharmaceuticals.
6. The Natural Health Products Directorate (NHPD) regulates natural products.
7. The Canadian Food and Drugs Acts is a regulatory document that specifies that drugs cannot be
marketed without a Notice of Compliance (NOC) and Drug Identification Number (DIN) from Health
Canada.
8. If a drug does not comply with standards set in the United States, Europe, Britain, or France, they
cannot be sold, labeled, packaged, or sold in Canada.
GENERAL CHAPTER CONSIDERATIONS
1. Have students study and learn key terms listed at beginning of chapter.
2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing
Student Resources website.
Marginal Notes
POWER POINT SLIDES 6–11
Figure 2.1 Patent Medicines Contained a Name Brand That Clearly Identified the Product and Claimed to
Cure Just about Any Symptom or Disease
Figure 2.1 Patent Medicines
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss with students how patent medicines have “survived” over along period of time. Use examples
given in the textbook such as Smith Cough Drops, Fletcher’s Castoria, Doan’s Pills, Vick’s Vapo Rub,
and Phillip’s Milk of Magnesia. Why are these products still popular and widely used? What could be
some of the reasons that they survived regulations?
POWERPOINT SLIDES 12–18
Table 2.1 Historical Time Line of Regulatory Acts, Standards, and Organization
Figure 2.2 USP Labels
SUGGESTION FOR CLASSROOM ACTIVITIES
• Using the time line in Table 2.1, have the students add any future regulations they believe are needed
or forthcoming.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students teach assigned patients in the clinical setting what U.S. regulations ensure the safety and
effectiveness of their drug therapy.
POWERPOINT SLIDES 19-20
SUGGESTION FOR CLASSROOM ACTIVITIES
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
• Have the students explore the USP website (www.usp.org). Have the students look at what type of
information is available such as reference standards, healthcare quality and information, seminars,
workshops, and drug safety review. Discuss how they could use this information in clinical practice.
POWERPOINT SLIDES 21–23
Figure 2.3 U.S. Food and Drug Administration
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Have the students log onto the FDA website (http://fda.com). Then, have the students explore the
consumer links and resources. Assign a different link or resource to each student; have them give a
brief summary if they thought there source would be helpful to the general patient population.
Students can choose an FDA industry link to explore. Break students into groups and assign one of the
following to each group: CDER, CBER, CFSAN, MedWatch, Health Care Professional, Food Nutrition
Industry, and Cosmetic Industry. Have the students report back to the group what information is available.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the students explain to their assigned patients how the FDA oversees drug products in the United
States. If Internet access is available, the student can demonstrate the consumer links on the FDA
website (http://fda.com).
POWER POINT SLIDES 24–29
Figure 2.4 Drug Development Time Line
SUGGESTION FOR CLASSROOM ACTIVITIES
• Break the students into groups, give each group one of the three phases of the clinical drug trial, have
them develop a patient teaching tool to provide teaching to the patient involved in that phase of the
trial. How would they explain safety, adverse effects, and patient variables?
SUGGESTION FOR CLINICAL ACTIVITIES
• If possible in your clinical setting, have the students interview either a healthcare professional or
patient involved in a clinical drug trial. They should ask questions about stages and phases of the trial,
preclinical investigation, goal of the trial, possible adverse effects, and patient consents and
compensations. Have them report back to their clinical group what they learned in their interview. Did
it change their thoughts about clinical drug trials? Why or why not?
SUGGESTION FOR CLASSROOM ACTIVITIES
• Build off the activity for Learning Outcome 5 and continue to discuss clinical drug trials. Why do some
patients receive the placebo? Is there a risk with placebos? How would the patient feel about getting
the placebo if the drug was very effective? Discuss the moral issues regarding controlled drug trials.
POWERPOINT SLIDES 30–32
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss with the class which disease states could require priority drug approval. Make a list on the
classroom blackboard. Ask the students then to prioritize their list. Discuss how difficult it is to decide
• Have the students explore the USP website (www.usp.org). Have the students look at what type of
information is available such as reference standards, healthcare quality and information, seminars,
workshops, and drug safety review. Discuss how they could use this information in clinical practice.
POWERPOINT SLIDES 21–23
Figure 2.3 U.S. Food and Drug Administration
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Have the students log onto the FDA website (http://fda.com). Then, have the students explore the
consumer links and resources. Assign a different link or resource to each student; have them give a
brief summary if they thought there source would be helpful to the general patient population.
Students can choose an FDA industry link to explore. Break students into groups and assign one of the
following to each group: CDER, CBER, CFSAN, MedWatch, Health Care Professional, Food Nutrition
Industry, and Cosmetic Industry. Have the students report back to the group what information is available.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have the students explain to their assigned patients how the FDA oversees drug products in the United
States. If Internet access is available, the student can demonstrate the consumer links on the FDA
website (http://fda.com).
POWER POINT SLIDES 24–29
Figure 2.4 Drug Development Time Line
SUGGESTION FOR CLASSROOM ACTIVITIES
• Break the students into groups, give each group one of the three phases of the clinical drug trial, have
them develop a patient teaching tool to provide teaching to the patient involved in that phase of the
trial. How would they explain safety, adverse effects, and patient variables?
SUGGESTION FOR CLINICAL ACTIVITIES
• If possible in your clinical setting, have the students interview either a healthcare professional or
patient involved in a clinical drug trial. They should ask questions about stages and phases of the trial,
preclinical investigation, goal of the trial, possible adverse effects, and patient consents and
compensations. Have them report back to their clinical group what they learned in their interview. Did
it change their thoughts about clinical drug trials? Why or why not?
SUGGESTION FOR CLASSROOM ACTIVITIES
• Build off the activity for Learning Outcome 5 and continue to discuss clinical drug trials. Why do some
patients receive the placebo? Is there a risk with placebos? How would the patient feel about getting
the placebo if the drug was very effective? Discuss the moral issues regarding controlled drug trials.
POWERPOINT SLIDES 30–32
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss with the class which disease states could require priority drug approval. Make a list on the
classroom blackboard. Ask the students then to prioritize their list. Discuss how difficult it is to decide
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
which disease is “more important.” Discuss if the list would be different in another part of the country
or world.
POWERPOINT SLIDES 19–39
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss some of the recent drugs that have been reclassified from prescription to over the counter, such
as loratadine (Claritin), cetirizine (Zyrtec), Omeprazole (Prilosec), famotidine (Pepcid), naproxen
sodium (Aleve), and cromolyn sodium nasal spray (Nasalcrom). Discuss the potential for use and
misuse by the consumer. Why are these drugs safer than other drugs in the same category that are still
prescription drugs? Does their classification help or harm the consumer?
SUGGESTION FOR CLINICAL ACTIVITIES
• Assign the students to a patient who is prescribed a drug that is available over the counter. Have the
students develop a patient teaching plan that will teach the patient how to use the drug safely and how
to follow the guidelines.
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Provide the students with a list of some controlled substance medications. Have the student pick one
drug and investigate its use and safety. Have them report back to the class if they think the assigned
schedule is appropriate or not. Discuss the arguments presented in class.
• Refer to the DEA website for a list of controlled substances:
http://www.usdoj.gov/dea/pubs/scheduling.html
SUGGESTIONS FOR CLINICAL ACTIVITIES
• Have the students shadow a nurse or pharmacist who prepares controlled substance medications. Have
the student note the regulations in that clinical setting for recording and dispensing the drugs. Have the
students report if they think the regulations are appropriate or not. What would they change, if
anything?
• Refer to the DEA website about the controlled substance act:
http://www.usdoj.gov/dea/pubs/scheduling.html
POWERPOINT SLIDES 40–46
Table 2.2 Steps for Approval for Drugs Marketed Within Canada
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Explore the Health Canada website with the students: http://www.hc-sc.gc.ca/index-eng.php
• Compare and contrast information found on that site against U.S. sites, such as the FDA (www.fda.gov)
or the Centers for Disease Control (www.cdc.gov).
• What information is provided on the websites for healthcare professionals? What information is
provided for the consumer?
• Discuss if information is easy to find and to understand. Focus on drug standards and safety.
which disease is “more important.” Discuss if the list would be different in another part of the country
or world.
POWERPOINT SLIDES 19–39
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss some of the recent drugs that have been reclassified from prescription to over the counter, such
as loratadine (Claritin), cetirizine (Zyrtec), Omeprazole (Prilosec), famotidine (Pepcid), naproxen
sodium (Aleve), and cromolyn sodium nasal spray (Nasalcrom). Discuss the potential for use and
misuse by the consumer. Why are these drugs safer than other drugs in the same category that are still
prescription drugs? Does their classification help or harm the consumer?
SUGGESTION FOR CLINICAL ACTIVITIES
• Assign the students to a patient who is prescribed a drug that is available over the counter. Have the
students develop a patient teaching plan that will teach the patient how to use the drug safely and how
to follow the guidelines.
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Provide the students with a list of some controlled substance medications. Have the student pick one
drug and investigate its use and safety. Have them report back to the class if they think the assigned
schedule is appropriate or not. Discuss the arguments presented in class.
• Refer to the DEA website for a list of controlled substances:
http://www.usdoj.gov/dea/pubs/scheduling.html
SUGGESTIONS FOR CLINICAL ACTIVITIES
• Have the students shadow a nurse or pharmacist who prepares controlled substance medications. Have
the student note the regulations in that clinical setting for recording and dispensing the drugs. Have the
students report if they think the regulations are appropriate or not. What would they change, if
anything?
• Refer to the DEA website about the controlled substance act:
http://www.usdoj.gov/dea/pubs/scheduling.html
POWERPOINT SLIDES 40–46
Table 2.2 Steps for Approval for Drugs Marketed Within Canada
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Explore the Health Canada website with the students: http://www.hc-sc.gc.ca/index-eng.php
• Compare and contrast information found on that site against U.S. sites, such as the FDA (www.fda.gov)
or the Centers for Disease Control (www.cdc.gov).
• What information is provided on the websites for healthcare professionals? What information is
provided for the consumer?
• Discuss if information is easy to find and to understand. Focus on drug standards and safety.
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PEARSON NURSING STUDENT RESOURCES (WWW.NURSING.PEARSONHIGHERED.COM)
• WEBLINKS
• NCLEX®-STYLE REVIEW QUESTIONS
• CASE STUDIES
• MAKING THE PATIENT CONNECTION
• MECHANISM OF ACTION ANIMATIONS
MY NURSING LAB (WWW.MYNURSINGLAB.COM)
• Knowledge Quick Check
• Pre/Post tests
• Customized study plans
• Separate purchase
PRENTICE HALL NURSE’S DRUG GUIDE
• Separate purchase
PEARSON ETEXT
• Students can search, highlight, take notes, and more all in electronic format
• Separate purchase
MYTEST
PEARSON NURSING STUDENT RESOURCES (WWW.NURSING.PEARSONHIGHERED.COM)
• WEBLINKS
• NCLEX®-STYLE REVIEW QUESTIONS
• CASE STUDIES
• MAKING THE PATIENT CONNECTION
• MECHANISM OF ACTION ANIMATIONS
MY NURSING LAB (WWW.MYNURSINGLAB.COM)
• Knowledge Quick Check
• Pre/Post tests
• Customized study plans
• Separate purchase
PRENTICE HALL NURSE’S DRUG GUIDE
• Separate purchase
PEARSON ETEXT
• Students can search, highlight, take notes, and more all in electronic format
• Separate purchase
MYTEST
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
CHAPTER 3
PRINCIPLES OF DRUG ADMINISTRATION
LEARNING OUTCOME 1
Outline a plan for improving patient adherence to the medical regimen.
Concepts for Lecture
1. Medication adherence involves determining whether the patient is taking the medication correctly.
2. Patient nonadherence to medication use is a major problem causing significant problems and even
death. Factors influencing nonadherence include:
a. Forgetting doses of drugs
b. Expense
c. Side effects
d. Self-adjustment of dosages
e. Discontinues use when feeling better
3. The nurse plays a significant role in determining patient adherence to drug use, including:
a. All medication is taken
b. Medication is taken at correct time
c. Correct dose of medication is taken
4. The nurse needs to formulate a care plan which involves the patient, and is designed to improve
adherence with medication use. Elements of the personalized plan of care include such essential
information as:
a. Name of medication
b. Reason for use
c. Expected drug action
d. Side effects
e. Significant interactions with medications, food, and herbal supplements
f. Assess ability for self-administration
LEARNING OUTCOME 2
Describe how the storage of drugs can affect their effectiveness.
Concepts for Lecture
CHAPTER 3
PRINCIPLES OF DRUG ADMINISTRATION
LEARNING OUTCOME 1
Outline a plan for improving patient adherence to the medical regimen.
Concepts for Lecture
1. Medication adherence involves determining whether the patient is taking the medication correctly.
2. Patient nonadherence to medication use is a major problem causing significant problems and even
death. Factors influencing nonadherence include:
a. Forgetting doses of drugs
b. Expense
c. Side effects
d. Self-adjustment of dosages
e. Discontinues use when feeling better
3. The nurse plays a significant role in determining patient adherence to drug use, including:
a. All medication is taken
b. Medication is taken at correct time
c. Correct dose of medication is taken
4. The nurse needs to formulate a care plan which involves the patient, and is designed to improve
adherence with medication use. Elements of the personalized plan of care include such essential
information as:
a. Name of medication
b. Reason for use
c. Expected drug action
d. Side effects
e. Significant interactions with medications, food, and herbal supplements
f. Assess ability for self-administration
LEARNING OUTCOME 2
Describe how the storage of drugs can affect their effectiveness.
Concepts for Lecture
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
1. Proper storage of medications is needed to protect medications from deterioration.
2. Nurses need to check that medications are properly stored and check for expiration dates before
administering.
3. Do not use any medications that are past expiration date; dispose of them properly.
4. Exposure to light and moisture can be damaging to some drugs.
5. Medication storage principles include:
a. Store at recommended temperature
b. High humidity enhances deterioration
c. Schedule drugs have restricted access
d. Check drugs for unusual color or textures
6. Access to scheduled drugs is restricted and requires adherence to institution policy.
LEARNING OUTCOME 3
Describe the components of a legal prescription and the abbreviations associated with drug orders.
Concepts for Lecture
1. Prescriptions may be written in different formats, but all must include the three elements of heading,
body, and closing.
2. The heading must include:
a. Date
b. Patient’s name
c. Prescriber’s name, address, phone number
3. The closing must include:
a. Prescriber’s signature
b. Refill amount, if applicable
c. Generic equivalent substitution
4. States differ on the specific requirements to be included in a prescription.
5. Certain abbreviations can lead to errors and must be avoided.
6. Prescriptions for controlled substances require a Drug Enforcement Administration (DEA) number.
LEARNING OUTCOME 4
Relate the importance of dosing schedules to successful pharmacotherapeutic outcomes.
1. Proper storage of medications is needed to protect medications from deterioration.
2. Nurses need to check that medications are properly stored and check for expiration dates before
administering.
3. Do not use any medications that are past expiration date; dispose of them properly.
4. Exposure to light and moisture can be damaging to some drugs.
5. Medication storage principles include:
a. Store at recommended temperature
b. High humidity enhances deterioration
c. Schedule drugs have restricted access
d. Check drugs for unusual color or textures
6. Access to scheduled drugs is restricted and requires adherence to institution policy.
LEARNING OUTCOME 3
Describe the components of a legal prescription and the abbreviations associated with drug orders.
Concepts for Lecture
1. Prescriptions may be written in different formats, but all must include the three elements of heading,
body, and closing.
2. The heading must include:
a. Date
b. Patient’s name
c. Prescriber’s name, address, phone number
3. The closing must include:
a. Prescriber’s signature
b. Refill amount, if applicable
c. Generic equivalent substitution
4. States differ on the specific requirements to be included in a prescription.
5. Certain abbreviations can lead to errors and must be avoided.
6. Prescriptions for controlled substances require a Drug Enforcement Administration (DEA) number.
LEARNING OUTCOME 4
Relate the importance of dosing schedules to successful pharmacotherapeutic outcomes.
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Concepts for Lecture
1. Dosage scheduling and intervals are determined by the health care provider based on the chemical
characteristics of a drug, purpose and action of the drug, and frequency with which it should be taken.
2. The usual dosing is 1–4 times/day. Many drug dosing schedules are determined by agency protocol.
3. The administration time should enhance therapeutic effectiveness. Patients must avoid skipping doses
or double dosing.
4. Some drugs have an irregular schedule, such as drugs ordered to be given STAT and prn.
LEARNING OUTCOME 5
Compare and contrast the three systems of measurement used in pharmacology.
Concepts for Lecture
1. Dosages are labeled by weight and volume.
2. Measuring systems used in pharmacology include metric, apothecary, and household.
3. The metric system is the most common.
4. Metric volume = liter (L) or milliliter (mL).
5. Metric weights are as follows:
a. Kilogram
b. Milligram
c. Microgram
6. In the household system, the tablespoon, teaspoon, and cup are the most common measurements.
7. Conversions between household and metric are as follows:
a. 240 mL = 8 ounces
b. 5 mL = 1 tsp
8. The apothecary system is the most infrequently used system:
a. Basic unit is the grain (gr)
b. Unit dosing is common
c. Knowledge of dosage calculation important
9. Although many drugs are dispensed in unit doses from the pharmacy, it is still important for the nurse
to have a working knowledge of dosage calculations.
10. The volume of a drug is expressed differently in each of the measuring systems.
Concepts for Lecture
1. Dosage scheduling and intervals are determined by the health care provider based on the chemical
characteristics of a drug, purpose and action of the drug, and frequency with which it should be taken.
2. The usual dosing is 1–4 times/day. Many drug dosing schedules are determined by agency protocol.
3. The administration time should enhance therapeutic effectiveness. Patients must avoid skipping doses
or double dosing.
4. Some drugs have an irregular schedule, such as drugs ordered to be given STAT and prn.
LEARNING OUTCOME 5
Compare and contrast the three systems of measurement used in pharmacology.
Concepts for Lecture
1. Dosages are labeled by weight and volume.
2. Measuring systems used in pharmacology include metric, apothecary, and household.
3. The metric system is the most common.
4. Metric volume = liter (L) or milliliter (mL).
5. Metric weights are as follows:
a. Kilogram
b. Milligram
c. Microgram
6. In the household system, the tablespoon, teaspoon, and cup are the most common measurements.
7. Conversions between household and metric are as follows:
a. 240 mL = 8 ounces
b. 5 mL = 1 tsp
8. The apothecary system is the most infrequently used system:
a. Basic unit is the grain (gr)
b. Unit dosing is common
c. Knowledge of dosage calculation important
9. Although many drugs are dispensed in unit doses from the pharmacy, it is still important for the nurse
to have a working knowledge of dosage calculations.
10. The volume of a drug is expressed differently in each of the measuring systems.
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LEARNING OUTCOME 6
Explain the importance of properly documenting medication administration.
Concepts for Lecture
1. Proper documentation of drug administration by the nurse is essential. This includes recording
initials/signature after the medication is given.
2. Documentation of a drug is done on the medication administration record (MAR).
3. Documentation of medication administration is done after the drug is given to the patient.
4. Documentation also includes patient refusals, concerns, and any adverse effects.
LEARNING OUTCOME 7
Compare and contrast enteral, topical, and parenteral drug administration.
Concepts for Lecture
1. Drugs are administered via different routes: parenteral, topical, and enteral.
2. Oral drugs are often enteric coated and designed for absorption in the small intestine.
3. Extended release tablets provide a longer duration of action and allow for the convenience of once- or
twice-daily dosing.
a. Most are absorbed in small intestine
b. Common endings: XR, X., LA, SR, -dur
c. Allow for longer duration of action
d. Do not crush, open, or chew
e. Exposure to stomach acid destroys medication
f. Some coated to mask a taste or prevent staining
4. Sublingual and buccal medications:
a. Extensive capillaries provide excellent absorption
b. Prevents exposure to stomach acids
c. Do not undergo hepatic first-pass metabolism
d. Sublingual provides rapid onset:
i. Administer after other medications
ii. Avoid eating or drinking until drug is dissolved
5. Nasogastric (NG) and gastrostomy medication administration:
LEARNING OUTCOME 6
Explain the importance of properly documenting medication administration.
Concepts for Lecture
1. Proper documentation of drug administration by the nurse is essential. This includes recording
initials/signature after the medication is given.
2. Documentation of a drug is done on the medication administration record (MAR).
3. Documentation of medication administration is done after the drug is given to the patient.
4. Documentation also includes patient refusals, concerns, and any adverse effects.
LEARNING OUTCOME 7
Compare and contrast enteral, topical, and parenteral drug administration.
Concepts for Lecture
1. Drugs are administered via different routes: parenteral, topical, and enteral.
2. Oral drugs are often enteric coated and designed for absorption in the small intestine.
3. Extended release tablets provide a longer duration of action and allow for the convenience of once- or
twice-daily dosing.
a. Most are absorbed in small intestine
b. Common endings: XR, X., LA, SR, -dur
c. Allow for longer duration of action
d. Do not crush, open, or chew
e. Exposure to stomach acid destroys medication
f. Some coated to mask a taste or prevent staining
4. Sublingual and buccal medications:
a. Extensive capillaries provide excellent absorption
b. Prevents exposure to stomach acids
c. Do not undergo hepatic first-pass metabolism
d. Sublingual provides rapid onset:
i. Administer after other medications
ii. Avoid eating or drinking until drug is dissolved
5. Nasogastric (NG) and gastrostomy medication administration:
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a. Used for long-term treatment
b. NG route used for short-term treatment
c. Liquid drug formulation is best to use
d. Avoid crushing slow release (SR) tablets
e. Flush tubes to maintain patency
f. May crush and dissolve some tablets
6. Topical medications can be applied for local and systemic effects.
7. Topical medications include transdermal patches and creams/lotions, and ophthalmic, otic, vaginal,
and rectal routes.
8. Topical routes:
a. Dermatological topical medications are applied to skin
b. Instillations and irrigations are placed in body cavities and orifices
c. Inhalations are applied to respiratory tract:
i. Inhalations
ii. Nebulizers
iii. Positive pressure breathing machine
9. Topical drugs:
a. Can produce a local or systemic effect
b. Examples:
i. Local effects: nasal steroids
ii. Systemic effects: nitroglycerin patch
c. Identify desired effect of drug
d. Avoid application to abraded or open skin
10. Transdermal delivery systems:
a. Deliver specific amount of drug through skin
b. Rotate site of application
c. Check that previous patch is removed
d. Dispose of used patches properly
11. Other topical routes:
a. Used for long-term treatment
b. NG route used for short-term treatment
c. Liquid drug formulation is best to use
d. Avoid crushing slow release (SR) tablets
e. Flush tubes to maintain patency
f. May crush and dissolve some tablets
6. Topical medications can be applied for local and systemic effects.
7. Topical medications include transdermal patches and creams/lotions, and ophthalmic, otic, vaginal,
and rectal routes.
8. Topical routes:
a. Dermatological topical medications are applied to skin
b. Instillations and irrigations are placed in body cavities and orifices
c. Inhalations are applied to respiratory tract:
i. Inhalations
ii. Nebulizers
iii. Positive pressure breathing machine
9. Topical drugs:
a. Can produce a local or systemic effect
b. Examples:
i. Local effects: nasal steroids
ii. Systemic effects: nitroglycerin patch
c. Identify desired effect of drug
d. Avoid application to abraded or open skin
10. Transdermal delivery systems:
a. Deliver specific amount of drug through skin
b. Rotate site of application
c. Check that previous patch is removed
d. Dispose of used patches properly
11. Other topical routes:
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
a. Ophthalmic
b. Otic
c. Nasal
d. Vaginal
e. Rectal
12. Enteral route:
a. Drug given through the GI tract
b. The safest route
c. Consider patients’ ability to swallow
d. Oral drug forms:
i. Tablet
ii. Capsule
iii. Enteric coated tablets
13. Parenteral administration requires the use of a needle to inject medications into the intradermal,
subcutaneous, intramuscular, or intravenous site.
14. Parenteral routes:
a. Administers drug into skin layers:
i. Intradermal
ii. Subcutaneous
iii. Intramuscular
iv. Intravenous
b. More invasive
c. Specialized equipment and techniques needed
d. Avoids digestive enzymes and first-pass effect
15. Intradermal and subcutaneous routes:
a. Dermis may contain blood vessels
b. Intradermal route mostly used for allergy testing
i. Injection contains only 0.1 to 0.2 mL
c. Subcutaneous site is easily accessible:
a. Ophthalmic
b. Otic
c. Nasal
d. Vaginal
e. Rectal
12. Enteral route:
a. Drug given through the GI tract
b. The safest route
c. Consider patients’ ability to swallow
d. Oral drug forms:
i. Tablet
ii. Capsule
iii. Enteric coated tablets
13. Parenteral administration requires the use of a needle to inject medications into the intradermal,
subcutaneous, intramuscular, or intravenous site.
14. Parenteral routes:
a. Administers drug into skin layers:
i. Intradermal
ii. Subcutaneous
iii. Intramuscular
iv. Intravenous
b. More invasive
c. Specialized equipment and techniques needed
d. Avoids digestive enzymes and first-pass effect
15. Intradermal and subcutaneous routes:
a. Dermis may contain blood vessels
b. Intradermal route mostly used for allergy testing
i. Injection contains only 0.1 to 0.2 mL
c. Subcutaneous site is easily accessible:
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i. Delivers drug to deepest skin layer
ii. Injection volumes range from 0.5 to 1.0 mL
16. Intramuscular route:
a. Drug is delivered into muscle
b. More rapid response than oral or subcutaneous
c. Select site away from bone, nerves, and large blood vessels
d. Injection volume should not exceed 3 mL:
i. Deltoid site is limited to 1 mL
17. Intravenous route:
a. Drug is delivered directly into bloodstream
b. Rapid onset of drug action
c. Most dangerous route
d. Three basic types:
i. Large volume infusion
ii. Intermittent infusion
iii. Bolus administration
GENERAL CHAPTER CONSIDERATIONS
1. Have students study and learn key terms listed at beginning of chapter.
2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing
Student Resources website.
Marginal Notes
POWERPOINT SLIDES 4–10
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss the necessary elements to include when developing an individualized teaching plan and ways
to include the patient and family.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students develop a personalized medication teaching plan for a patient they have had in clinical.
REAL NURSING SKILLS
Medication Administration Videos.
i. Delivers drug to deepest skin layer
ii. Injection volumes range from 0.5 to 1.0 mL
16. Intramuscular route:
a. Drug is delivered into muscle
b. More rapid response than oral or subcutaneous
c. Select site away from bone, nerves, and large blood vessels
d. Injection volume should not exceed 3 mL:
i. Deltoid site is limited to 1 mL
17. Intravenous route:
a. Drug is delivered directly into bloodstream
b. Rapid onset of drug action
c. Most dangerous route
d. Three basic types:
i. Large volume infusion
ii. Intermittent infusion
iii. Bolus administration
GENERAL CHAPTER CONSIDERATIONS
1. Have students study and learn key terms listed at beginning of chapter.
2. Have students complete end of chapter exercises either in their book or on the Pearson Nursing
Student Resources website.
Marginal Notes
POWERPOINT SLIDES 4–10
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss the necessary elements to include when developing an individualized teaching plan and ways
to include the patient and family.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students develop a personalized medication teaching plan for a patient they have had in clinical.
REAL NURSING SKILLS
Medication Administration Videos.
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Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
POWERPOINT SLIDES 11–12
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Discuss the effect that heat and humidity have on the storage of medications.
• Relate the effect of medication storage to shelf life.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students check where different medications are stored at the clinical site.
REFERENCE
• Proper Disposal of Prescription Drugs: Federal Guidelines. (n.d.). Drug Facts: Office of National Drug
Control Policy Guidelines. Retrieved April 18, 2008 from www.whitehouse.gov/ondcp
POWERPOINT SLIDES 13–16
Figure 3.1 Sample Prescription
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students practice writing a sample prescription with all the required components.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students choose a recently written prescription on a patient chart; identify and determine if all the
required components are present. If any component is missing or incorrect, discuss what action should
be taken by the nurse.
REAL NURSING SKILLS
Medication Administration Videos.
REFERENCE
• The ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations. (2006). Retrieved
April 18, 2008 from www.ismp.org/tools/errorproneabbreviations.pdf
POWERPOINT SLIDES 17–19
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss the nurse’s responsibility when a patient in apparent pain refuses to take a prn pain medication.
Another scenario could involve a patient who has an elevated temperature and refuses to take the prn
acetaminophen. Discuss how the nurse can best handle these types of situations.
SUGGESTION FOR CLINICAL ACTIVITIES
• Choose a patient assigned to one of the students and examine the rationale for the dosing schedule of
their prescribed medications.
POWERPOINT SLIDES 20–24
POWERPOINT SLIDES 11–12
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Discuss the effect that heat and humidity have on the storage of medications.
• Relate the effect of medication storage to shelf life.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students check where different medications are stored at the clinical site.
REFERENCE
• Proper Disposal of Prescription Drugs: Federal Guidelines. (n.d.). Drug Facts: Office of National Drug
Control Policy Guidelines. Retrieved April 18, 2008 from www.whitehouse.gov/ondcp
POWERPOINT SLIDES 13–16
Figure 3.1 Sample Prescription
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students practice writing a sample prescription with all the required components.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students choose a recently written prescription on a patient chart; identify and determine if all the
required components are present. If any component is missing or incorrect, discuss what action should
be taken by the nurse.
REAL NURSING SKILLS
Medication Administration Videos.
REFERENCE
• The ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations. (2006). Retrieved
April 18, 2008 from www.ismp.org/tools/errorproneabbreviations.pdf
POWERPOINT SLIDES 17–19
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss the nurse’s responsibility when a patient in apparent pain refuses to take a prn pain medication.
Another scenario could involve a patient who has an elevated temperature and refuses to take the prn
acetaminophen. Discuss how the nurse can best handle these types of situations.
SUGGESTION FOR CLINICAL ACTIVITIES
• Choose a patient assigned to one of the students and examine the rationale for the dosing schedule of
their prescribed medications.
POWERPOINT SLIDES 20–24
Loading page 28...
Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students practice converting some common drugs from one system to another, such as metric to
household or metric to apothecary.
SUGGESTION FOR CLINICAL ACTIVITIES
• Look for examples of drugs that may come packaged in a different system of measurement than was
ordered by the health care provider, such as levothyroxine or nitroglycerin, and illustrate these
examples.
POWERPOINT SLIDES 25–26
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss some of the possible consequences that can occur when medications are not properly charted,
such as a patient receiving a double dose of medication.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students identify what is most important to document following a medication that they have just
administered. Discuss any significant information or assessment data that needs to be included, such as
vital signs or a patient complaint.
POWERPOINT SLIDES 27–43
Figure 3.2 Sublingual Medication Administration
Figure 3.3 Transdermal Patch Administration
Figure 3.4 Ophthalmic Administration
Figure 3.5 Vaginal Medication Administration
Figure 3.6 Intradermal Drug Administration
Figure 3.7 Subcutaneous Drug Administration
Figure 3.8 Intramuscular Drug Administration
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Give an example of a drug, such as morphine, that can be administered by the subcutaneous,
intramuscular, and intravenous routes. Discuss when each site would be the more appropriate choice.
• Discuss the differences in sublingual and buccal medications. Demonstrate proper placement using
OTC lozenges or candy.
SUGGESTION FOR CLINICAL ACTIVITIES
• Assign each student a parenteral medication, checking that it is prepared in the correct size syringe
with correct needle length and gauge. Discuss why the size and gauge of the needle is appropriate for
the particular medication and the specific patient.
SUGGESTION FOR CLASSROOM ACTIVITIES
• Have students practice converting some common drugs from one system to another, such as metric to
household or metric to apothecary.
SUGGESTION FOR CLINICAL ACTIVITIES
• Look for examples of drugs that may come packaged in a different system of measurement than was
ordered by the health care provider, such as levothyroxine or nitroglycerin, and illustrate these
examples.
POWERPOINT SLIDES 25–26
SUGGESTION FOR CLASSROOM ACTIVITIES
• Discuss some of the possible consequences that can occur when medications are not properly charted,
such as a patient receiving a double dose of medication.
SUGGESTION FOR CLINICAL ACTIVITIES
• Have students identify what is most important to document following a medication that they have just
administered. Discuss any significant information or assessment data that needs to be included, such as
vital signs or a patient complaint.
POWERPOINT SLIDES 27–43
Figure 3.2 Sublingual Medication Administration
Figure 3.3 Transdermal Patch Administration
Figure 3.4 Ophthalmic Administration
Figure 3.5 Vaginal Medication Administration
Figure 3.6 Intradermal Drug Administration
Figure 3.7 Subcutaneous Drug Administration
Figure 3.8 Intramuscular Drug Administration
SUGGESTIONS FOR CLASSROOM ACTIVITIES
• Give an example of a drug, such as morphine, that can be administered by the subcutaneous,
intramuscular, and intravenous routes. Discuss when each site would be the more appropriate choice.
• Discuss the differences in sublingual and buccal medications. Demonstrate proper placement using
OTC lozenges or candy.
SUGGESTION FOR CLINICAL ACTIVITIES
• Assign each student a parenteral medication, checking that it is prepared in the correct size syringe
with correct needle length and gauge. Discuss why the size and gauge of the needle is appropriate for
the particular medication and the specific patient.
Loading page 29...
Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
PEARSON NURSING STUDENT RESOURCES (WWW.NURSING.PEARSONHIGHERED.COM)
• WebLinks
• NCLEX®-style review questions
• Case studies
• Making the Patient Connection
• Mechanism of Action Animations
MYNURSINGLAB (WWW.MYNURSINGLAB.COM)
• Knowledge Quick Check
• Pre/Posttests
• Customized study plans
• Separate purchase
PRENTICE HALL NURSE’S DRUG GUIDE
• Separate purchase
PEARSON ETEXT
• Students can search, highlight, take notes, and more all in electronic format
• Separate purchase
MYTEST
PEARSON NURSING STUDENT RESOURCES (WWW.NURSING.PEARSONHIGHERED.COM)
• WebLinks
• NCLEX®-style review questions
• Case studies
• Making the Patient Connection
• Mechanism of Action Animations
MYNURSINGLAB (WWW.MYNURSINGLAB.COM)
• Knowledge Quick Check
• Pre/Posttests
• Customized study plans
• Separate purchase
PRENTICE HALL NURSE’S DRUG GUIDE
• Separate purchase
PEARSON ETEXT
• Students can search, highlight, take notes, and more all in electronic format
• Separate purchase
MYTEST
Loading page 30...
Adams/Urban, Instructor’s Resource Manual for Pharmacology: Connections to Nursing Practice, 2nd Edition
CHAPTER 4
PHARMACOKINETICS
LEARNING OUTCOME 1
Identify the four primary processes of pharmacokinetics.
Concepts for Lecture
1. Pharmacokinetics is what the body does to drugs. Pharmaco means “medicines,” and kinetics means
“movement.”
2. The four phases of pharmacokinetics are: absorption, distribution, metabolism, and excretion.
3. A drug must go through all phases before being eliminated by the body.
LEARNING OUTCOME 2
Explain mechanisms by which drugs cross plasma membranes.
Concepts for Lecture
1. Various mechanisms are used by drugs to reach target tissues. These can involve passive diffusion,
active transport, and facilitated diffusion.
2. Passive diffusion involves movement from an area of high concentration to one of low concentration.
3. Facilitated diffusion involves utilization of a carrier protein.
4. Active transport involves movement against a concentration gradient, which requires energy.
LEARNING OUTCOME 3
Discuss factors affecting drug absorption.
Concepts for Lecture
1. The first phase of pharmacokinetics, absorption, is affected by many different factors.
2. Factors affecting absorption:
a. Oral meds must undergo dissolution
b. Topical drugs can have slow or rapid absorption
c. Drug concentration/dose
d. Physical and chemical condition of GI tract:
i. Motility
ii. Presence of food/fat in stomach
CHAPTER 4
PHARMACOKINETICS
LEARNING OUTCOME 1
Identify the four primary processes of pharmacokinetics.
Concepts for Lecture
1. Pharmacokinetics is what the body does to drugs. Pharmaco means “medicines,” and kinetics means
“movement.”
2. The four phases of pharmacokinetics are: absorption, distribution, metabolism, and excretion.
3. A drug must go through all phases before being eliminated by the body.
LEARNING OUTCOME 2
Explain mechanisms by which drugs cross plasma membranes.
Concepts for Lecture
1. Various mechanisms are used by drugs to reach target tissues. These can involve passive diffusion,
active transport, and facilitated diffusion.
2. Passive diffusion involves movement from an area of high concentration to one of low concentration.
3. Facilitated diffusion involves utilization of a carrier protein.
4. Active transport involves movement against a concentration gradient, which requires energy.
LEARNING OUTCOME 3
Discuss factors affecting drug absorption.
Concepts for Lecture
1. The first phase of pharmacokinetics, absorption, is affected by many different factors.
2. Factors affecting absorption:
a. Oral meds must undergo dissolution
b. Topical drugs can have slow or rapid absorption
c. Drug concentration/dose
d. Physical and chemical condition of GI tract:
i. Motility
ii. Presence of food/fat in stomach
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