Advanced Pharmacology for
Prescribers 1st Edition Theodore
Kendris
, Advanced
Pharmacology
for Prescribers
1st EdAdvanced
Pharmacology for
Prescribers
,s of America.
3. PHARMACODYNAMICS 17
James Uchizono and Patrick Chan
Introduction 17
PART I: FOUNDATIONS OF PHARMACOLOGY
h h h h Linking Dose to Response 17
AND PRESCRIBING
h h
Linear Model 18
Emax Model 19
1. AN INTRODUCTION TO EVIDENCE-BASED Complex Pharmacodynamic Behaviors
and Limitations 20
CLINICAL PRACTICE GUIDELINES 3
Adebola Olarewaju and George W. Rodway
CASE EXEMPLAR: Patient With Syncope 21
CASE EXEMPLAR: Patient With Pulmonary
Introduction 3 Embolism 21
Background 3
Clinical Guidelines 3 4. PHARMACOGENETICS AND
Utilization of Clinical Guidelines 3 PHARMACOGENOMICS 23
Benefits and Limitations
Kevin C. O’Connor, Xiaodong Feng, and Brent Luu
of Clinical Guidelines 4
Clinical Guideline Development 4 Introduction: Pharmacogenetics Versus
Conclusion 6 Pharmacogenomics 23
Background 23
2. PHARMACOKINETICS 9 Genomic Databases 24
Patrick Chan and James Uchizono Variations of Enzymes in Drug Metabolism 25
Variations in Transporters 29
Introduction 9 Variations in Immune System Function 31
Background 10 Drug–Drug Interactions and Genetic Polymorphism 32
Pharmacokinetic Processes 10 Cost Effectiveness of Pharmacogenomics 32
Absorption 10 Future of Pharmacogenomics 33
Distribution 11 CASE EXEMPLAR: Patient With Post-Concussive Syndrome
Drug Metabolism 11 39
Excretion 12
Pharmacokinetic Parameters 12 CASE EXEMPLAR: Patient With Nephrolithiasis 40
Bioavailability 12
Clearance 13 5. PHARMACOLOGY ACROSS THE LIFE SPAN 47
Volume of Distribution 13 Cynthia S. Valle-Oseguera, Melanie A. Felmlee, and
Elimination Rate Constant 13 Carly A. Ranson
Half-Life 14
Conclusion 14 Introduction 47
Pediatric Population 47
CASE EXEMPLAR: Patient With New-Onset Seizures 15
Overview 47
CASE EXEMPLAR: Patient With COVID-19 15 CASE EXEMPLAR: Newly Diagnosed Asthma 50
Pregnant and Lactating Population 50
Overview 50
v
, vi Contents
CASE EXEMPLAR: Female With Suspected CASE EXEMPLAR: Patient With Urinary Retention 82
Pregnancy 53
Geriatric Population 54
CASE EXEMPLAR: Patient With Skin Rash 82
Overview 54
Conclusion 56
8. FOUNDATIONS OF PRESCRIPTION WRITING 87
Brent Luu, Laura Van Auker, and David Grega
CASE EXEMPLAR: Female With Recent Fall and
Dizziness 57 Introduction 87
Federal Drug Law and Regulations 88 The
6. PRESCRIBING IN Drug Enforcement Administration 88
SPECIAL POPULATIONS 61 Requirements of a Valid Prescription 91
Reamer Bushardt and Courtney J. Perry Patient Information 91
Drug Information 91
Introduction 61 Generic Substitution 91
Optimizing Drug Therapy for Renal Function 61 Ethical Aspects of Prescribing 94
Optimizing Drug Therapy for Liver Function 63 Standard of Care for Specialty Populations 95
Drug Therapy in Pediatrics 65 Prescribing for Self, Family, and Nonpatients 95
Drug Therapy in the Elderly 67 Conscience Clause: Personal Belief Versus Professional
Conclusion 70 Responsibility 95
CASE EXEMPLAR: Patient With Altered Mental Off-Label Drug Use 96
Status 70 CASE EXEMPLAR: Patient With Antibiotic Treatment Failure
CASE EXEMPLAR: Patient With Acute Renal Failure 71 96
CASE EXEMPLAR: Patient With Bronchitis 97
7. DRUG DEVELOPMENT AND APPROVAL 75
Hongbin Wang, Peter Tenerelli, Simeon O. Kotchoni, 9. RESPONSIBLE
Ahmed El-Shamy, Erika Young, Michael Casner, and PRESCRIBING 101
Catherine F. Yang Vasco Deon Kidd, Andrew Lowe, Brent Luu, and Gerald Kayingo
Introduction 75 Introduction 101
The Process of New Drug Development and U.S. Food Background 101
and Drug Administration Approval 76
Target Identification 76 Opioid Prescribing: Acute Pain Management 102
Target Validation 76 Opioids Prescribing: Chronic Pain Management 102
Assay Development 76 Controlled-Substance Prescribing: Safety
Lead Generation 76 Improvement 103
Lead Optimization 77 Strategies to Mitigate Controlled-Substance
New Chemicals Entity Sources 77 Misuse 103
Clinical Trials 78 Improving Pain Management Through Effective
Phase 1 Clinical Trials 78 Communication 103
Phase 2 Clinical Trials 78 Conclusion 104
Phase 3 Clinical Trials 78 CASE EXEMPLAR: Patient With Traumatic Injury 105
Phase 4 Clinical Trials 78
GenericVersus Brand-Name Drugs 79
CASE EXEMPLAR: Patient With Osteoarthritis 106
The U.S. Food and Drug Administration Approval of
Generic Drugs 79 10. ANTIBIOTIC STEWARDSHIP 109
Bioequivalence Study of Generic Medications 79 Lucy W. Kibe
The Impact of Switching to Generic Drugs 79
Conversion of Drugs From Legend to Over-the- Introduction 109
Counter 80 The Burden of Antimicrobial Resistance 110
History of Prescription Versus Nonprescription Antibiotic Stewardship 113
Medications 80 Tenets of Multidisciplinary Antibiotic Stewardship 113
The Conversion Process of Prescription to Over-the- Conclusion 115
Counter 81
Labeling of Over-the-Counter Products 81 CASE EXEMPLAR: Patient With Earache 115
Benefits of the Prescription-to-Over-the-Counter CASE EXEMPLAR: Implementation of New Antibiotic
Switch 81 Guidelines 116
Risks Associated With Over-the-Counter
Medications 81
Conclusion 81
Prescribers 1st Edition Theodore
Kendris
, Advanced
Pharmacology
for Prescribers
1st EdAdvanced
Pharmacology for
Prescribers
,s of America.
3. PHARMACODYNAMICS 17
James Uchizono and Patrick Chan
Introduction 17
PART I: FOUNDATIONS OF PHARMACOLOGY
h h h h Linking Dose to Response 17
AND PRESCRIBING
h h
Linear Model 18
Emax Model 19
1. AN INTRODUCTION TO EVIDENCE-BASED Complex Pharmacodynamic Behaviors
and Limitations 20
CLINICAL PRACTICE GUIDELINES 3
Adebola Olarewaju and George W. Rodway
CASE EXEMPLAR: Patient With Syncope 21
CASE EXEMPLAR: Patient With Pulmonary
Introduction 3 Embolism 21
Background 3
Clinical Guidelines 3 4. PHARMACOGENETICS AND
Utilization of Clinical Guidelines 3 PHARMACOGENOMICS 23
Benefits and Limitations
Kevin C. O’Connor, Xiaodong Feng, and Brent Luu
of Clinical Guidelines 4
Clinical Guideline Development 4 Introduction: Pharmacogenetics Versus
Conclusion 6 Pharmacogenomics 23
Background 23
2. PHARMACOKINETICS 9 Genomic Databases 24
Patrick Chan and James Uchizono Variations of Enzymes in Drug Metabolism 25
Variations in Transporters 29
Introduction 9 Variations in Immune System Function 31
Background 10 Drug–Drug Interactions and Genetic Polymorphism 32
Pharmacokinetic Processes 10 Cost Effectiveness of Pharmacogenomics 32
Absorption 10 Future of Pharmacogenomics 33
Distribution 11 CASE EXEMPLAR: Patient With Post-Concussive Syndrome
Drug Metabolism 11 39
Excretion 12
Pharmacokinetic Parameters 12 CASE EXEMPLAR: Patient With Nephrolithiasis 40
Bioavailability 12
Clearance 13 5. PHARMACOLOGY ACROSS THE LIFE SPAN 47
Volume of Distribution 13 Cynthia S. Valle-Oseguera, Melanie A. Felmlee, and
Elimination Rate Constant 13 Carly A. Ranson
Half-Life 14
Conclusion 14 Introduction 47
Pediatric Population 47
CASE EXEMPLAR: Patient With New-Onset Seizures 15
Overview 47
CASE EXEMPLAR: Patient With COVID-19 15 CASE EXEMPLAR: Newly Diagnosed Asthma 50
Pregnant and Lactating Population 50
Overview 50
v
, vi Contents
CASE EXEMPLAR: Female With Suspected CASE EXEMPLAR: Patient With Urinary Retention 82
Pregnancy 53
Geriatric Population 54
CASE EXEMPLAR: Patient With Skin Rash 82
Overview 54
Conclusion 56
8. FOUNDATIONS OF PRESCRIPTION WRITING 87
Brent Luu, Laura Van Auker, and David Grega
CASE EXEMPLAR: Female With Recent Fall and
Dizziness 57 Introduction 87
Federal Drug Law and Regulations 88 The
6. PRESCRIBING IN Drug Enforcement Administration 88
SPECIAL POPULATIONS 61 Requirements of a Valid Prescription 91
Reamer Bushardt and Courtney J. Perry Patient Information 91
Drug Information 91
Introduction 61 Generic Substitution 91
Optimizing Drug Therapy for Renal Function 61 Ethical Aspects of Prescribing 94
Optimizing Drug Therapy for Liver Function 63 Standard of Care for Specialty Populations 95
Drug Therapy in Pediatrics 65 Prescribing for Self, Family, and Nonpatients 95
Drug Therapy in the Elderly 67 Conscience Clause: Personal Belief Versus Professional
Conclusion 70 Responsibility 95
CASE EXEMPLAR: Patient With Altered Mental Off-Label Drug Use 96
Status 70 CASE EXEMPLAR: Patient With Antibiotic Treatment Failure
CASE EXEMPLAR: Patient With Acute Renal Failure 71 96
CASE EXEMPLAR: Patient With Bronchitis 97
7. DRUG DEVELOPMENT AND APPROVAL 75
Hongbin Wang, Peter Tenerelli, Simeon O. Kotchoni, 9. RESPONSIBLE
Ahmed El-Shamy, Erika Young, Michael Casner, and PRESCRIBING 101
Catherine F. Yang Vasco Deon Kidd, Andrew Lowe, Brent Luu, and Gerald Kayingo
Introduction 75 Introduction 101
The Process of New Drug Development and U.S. Food Background 101
and Drug Administration Approval 76
Target Identification 76 Opioid Prescribing: Acute Pain Management 102
Target Validation 76 Opioids Prescribing: Chronic Pain Management 102
Assay Development 76 Controlled-Substance Prescribing: Safety
Lead Generation 76 Improvement 103
Lead Optimization 77 Strategies to Mitigate Controlled-Substance
New Chemicals Entity Sources 77 Misuse 103
Clinical Trials 78 Improving Pain Management Through Effective
Phase 1 Clinical Trials 78 Communication 103
Phase 2 Clinical Trials 78 Conclusion 104
Phase 3 Clinical Trials 78 CASE EXEMPLAR: Patient With Traumatic Injury 105
Phase 4 Clinical Trials 78
GenericVersus Brand-Name Drugs 79
CASE EXEMPLAR: Patient With Osteoarthritis 106
The U.S. Food and Drug Administration Approval of
Generic Drugs 79 10. ANTIBIOTIC STEWARDSHIP 109
Bioequivalence Study of Generic Medications 79 Lucy W. Kibe
The Impact of Switching to Generic Drugs 79
Conversion of Drugs From Legend to Over-the- Introduction 109
Counter 80 The Burden of Antimicrobial Resistance 110
History of Prescription Versus Nonprescription Antibiotic Stewardship 113
Medications 80 Tenets of Multidisciplinary Antibiotic Stewardship 113
The Conversion Process of Prescription to Over-the- Conclusion 115
Counter 81
Labeling of Over-the-Counter Products 81 CASE EXEMPLAR: Patient With Earache 115
Benefits of the Prescription-to-Over-the-Counter CASE EXEMPLAR: Implementation of New Antibiotic
Switch 81 Guidelines 116
Risks Associated With Over-the-Counter
Medications 81
Conclusion 81