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O'Donnell's Drug Injury, Fourth Edition - Lawyers & Judges Publishing Company, Inc.

O'Donnell's Drug Injury, Fourth Edition

$ 250.00

  • Editors: James T. O’Donnell and James J. O’Donnell III
  • ISBN 10: 1-936360-44-6
  • ISBN 13: 978-1-936360-44-4
  • Copyright Date Ed:  August 2, 2016
  • Pages: 1,024 pages
  • Binding Information: Hardcover:
  • Size: 8.5 ✕ 11 Inches (US)

If you are involved with the healthcare system as a practitioner or attorney, you know that cases involving drug-induced injury are as complex as they are common. While the injury to the patient might seem obvious, in reality that has very little effect on the course that the litigation will take. This makes it especially important to accurately evaluate the case.

Whether prosecuting or defending, you will want to be sure that the case has merit or can be successfully defended. To accomplish this, you need the knowledge of the drug development, regulation, pharmacists practice, and which drugs cause the most injuries. This is all carefully detailed in this new fourth edition by a medley of well-accomplished authors.

Easy for the non-medical professional to follow, the book is divided into four useful sections. Part I deals with the pharmaceutical process, covering the liability of pharmaceutical companies, warning labels and clinical trials. Part II examines high-risk drug therapies that result in pharmaceutical litigation. You’ll read about important litigation regarding drugs like opiates and pain medications, anticoagulants, steroids, insulin and oral diabetic drugs, as well as allergic reactions, and liver/kidney injuries caused by drugs. Whether or not your case involves the drug cited you’ll find that the theories applicable to one pharmaceutical case are often applicable to another. Part III looks at the professional pharmacist and malpractice claims. Finally, Part IV covers forensic and toxicological issues, particularly recreational drugs, drug testing, and pain equipotency.

You’ll find this text indispensable for the comprehensive information it provides for all those affiliated with the use of drugs in healthcare, in the community, and in the pharmaceutical industry.

This fourth edition includes brand new chapters on:

  • The Regulation of Drug Product Information to Consumers
  • The Role of Investigative Journalism in Improving Drug Safety
  • Consequences of Violations of DEA Controlled Substance Laws
  • Addiction as Mitigation
  • Drug-Induced Aggression and Violence
  • Drug-Induced Falls
  • Geriatric Medication Misadventures
  • Ketorolac Abuse and Injury in College Athletics
  • Pharmacogenomics: Using Precision Medicine to Decrease Adverse Drug
  • The Pharmacist’s Utilization of the National Patient Safety Goals to Contribute to Safe and Effective Medication Use
  • Forensic Criminal Analysis of Insulin and Sulfonylureas
  • Alcohol
  • Cocaine
  • Marijuana: Pharmacology and Medical-Legal Issues
  • Marijuana-Impaired or Just Cannabinoid Positive?

Table of Contents

Preface to Fourth Edition

Preface to Third Edition

Preface to Second Edition

About the Editors

About the Contributors

Part I: The Pharmaceutical Process

Chapter 1: The FDA and the Drug-Approval Process
Mary E. Kremzner, Pharm.D., MPH, CAPT, USPHS and Justina A. Molzon, M.S. Pharm., J.D.
1.1 Introduction
1.2 Clinical Studies (Overview)
1.3 Phases of Clinical Studies
A. Phase 1 Clinical Studies
B. Phase 2 Clinical Studies
C. Phase 3 Clinical Studies
1.4 Investigational New Drug (IND) Application
1.5 Expedited Development and Review Programs
A. Accelerated Approval, Subpart H
B. Expanded Access Programs
C. Treating Life-threatening and Severely-debilitating Illnesses, Subpart E
D. Priority Review
E. Fast Track
F. Breakthrough Therapy
1.6 New Drug Application and Biologic Drug Applications (NDA and BLA)
1.7 Prescription Drug User Fee Act
1.8 Fundamentals of NDA and BLA Submissions
1.9 NDA Classifications
1.10 Labeling Review
A. Pregnancy and Lactation Labeling Rule
1.11 Additional FDA-Approved Patient Labeling
1.12 Stakeholder Engagement
A. Advisory Committee Meetings
1.13 The Generic-Drug-Approval Process
A. Abbreviated New Drug Applications (ANDAs)
B. Bioequivalence Review
C. Chemistry or Microbiology Review
D. Labeling Review
E. ANDA Approval
1.14 Biosimilar Approval Pathway
1.15 Over-the-Counter Drug Products
1.16 Postmarketing Surveillance
A. Adverse Event Reporting
B. The FDA’s Adverse Event Reporting System (FAERS)
C. Post Marketing Requirements and Commitments
D. Sentinel Network
1.17 Drug Safety—Surveillance and Epidemiology
A. Office of Pharmacovigilance and Epidemiology
B. Office of Medication Error Prevention and Risk Management
C. Drug Safety and Risk Management Advisory Committee
1.18 Risk Evaluation and Mitigation Strategies (REMS)
1.19 Drug Safety Oversight Board
1.20 Recent FDA Initiatives Related to Drug Safety
A. Professional Affairs and Stakeholder Engagement (PASE)
B. FDASIA Supply Chain
C. The Drug Supply Chain Security Act
1.21 Applicable Statutes and Implementing Regulations
A. Food and Drug Acts of 1906
B. Food, Drug and Cosmetic Act (1938)
C. Durham-Humphrey Amendment (1951)
D. Kefauver-harris Amendments (1962)
E. Orphan Drug Act (1983)
F. Drug Price and Competition and Patent Term Restoration Act (1984)
1. Revision of New Drug Application Regulations (1985)
2. Revision of Investigational New Drug Application Regulations (1987)
3. Treatment Use of Investigational New Drugs (1987)
G. Prescription Drug User Fee Act (1992)
H. FDA Modernization Act (1997)
I. FDA Amendments Act (2007)
J. Food and Drug Administration Safety and Innovation Act (2012)
K. Drug Quality and Security Act (2013)
1.22 Controlling Statute
1.23 Classification as Food or Drug?
1.24 Conclusion

Chapter 2: The Dietary Supplement and Health Education Act of 1994 (DSHEA) and Related FDA Activities
Justina A. Molzon, M.S. Pharm., J.D. and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.
2.1 Definition of a Dietary Supplement
2.2 Overview of DSHEA
2.3 The FDA’s Role in Implementation of DSHEA
A. Elements of the Dietary Supplement Program
Scope of Responsibility
1. Good Manufacturing Practices
2. Labeling
3. Structure/function Statements
4. Authoritative Statement Health Claims
B. Boundaries of Regulatory Classification
C. Labeling of a Dietary Supplement
1. The New Requirements for Dietary Supplement Labels
2. “Supplement Facts” Panel
2.4 Claims Permitted under DSHEA
A. Structure/Function Claims
B. The FDA’s Dietary Supplement Proposal
C. Advertising
2.5 Monitoring the Safety of Dietary Supplements
A. MedWatch
B. Good Manufacturing Practices (GMPs) to Assure Quality
C. Literature Guidelines under DSHEA
D. Commission on Dietary Supplements
E. Office of Dietary Supplements
2.6 Growth of Dietary Supplement Industry
2.7 Future FDA Activities Related to DSHEA
A. Guidelines for Evaluating Herbal Medicines
B. Combination Drug Rule
C. FDA Research Efforts
2.8 Violations of DSHEA -More Aggressive Enforcement
A. Adulteration
B. Missing Ingredients - The NY AG Attack
C. False Claims
D. Toxicity and public health risks associated with dietary supplements
2.9 Conclusion (JTOD Opinion)

Chapter 3: Nonscientific Uses and Illegal Marketing of Drugs and Dietary Supplements
Stephen Barrett, M.D. and Robert S. Baratz, M.D., DDS, Ph.D.
3.1 Overview
3.2 Prescription Drugs
3.3 Irrational Use of Legal Drugs
A. Unwarranted Chelation Therapy
B. Excessive Antibiotic Usage for Alleged “Chronic Lyme Disease”
C. Hormones for “Anti-Aging” Purposes
3.4 “Bioidentical” Hormones
3.5 OTC Drugs
3.6 Vitamins, Minerals, and Other Dietary Supplements
3.7 “Nutritional Support” Statements
3.8 Herbal Problems
3.9 Homeopathic Products
3.10 Deceptive “Informed Consent” and Illicit Research
3.11 Government Jurisdiction
3.12 Recommended Reforms
3.13 Recommended Information Sources

Chapter 4: The Pharmaceutical Revolution: Drug Discovery and Development
John Somberg, M.D.
4.1 Introduction
4.2 Drugs from Plants
4.3 Synthetic Drug Discovery
4.4 Biotechnology, Genomics and Proteomics
4.5 Gene Therapy
4.6 Cell Therapy and Regenerative Therapies
4.7 The Developers
4.8 Small Development Companies
4.9 Academicians and Entrepreneurs
4.10 Government, Regulation and Drug Development
4.11 Government Research
4.12 The FDA Regulators
4.13 Protecting the Domestic Drug Supply
4.14 Conclusion

Chapter 5: Clinical Research: Testing Treatments in Humans
Lori Nesbitt, Pharm.D., MBA
5.1 Introduction
5.2 Testing Drugs in Humans
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
E. Translational Research
F. Health Outcomes Research
G. Comparative/Clinical Effectiveness Research
5.3 Clinical Research: Not an Exact Science
5.4 Study Design
A. Control Groups
B. Random Assignment
C. Double-Blind
D. Crossover Design
E. Historical Control
5.5 Elements of the Clinical-Trial Protocol
A. Background and Significance
B. Specific Aims or Endpoints
C. Inclusion and Exclusion Criteria
D. Study Procedures
E. Statistical Design
5.6 Medical Research and Discovery Overview
A. The Role of Public Versus Private Sector in Research and Development
B. Current Life Cycle Costs for Research and Development of New Drugs
5.7 Clinical-Trial Service Providers
A. The Food and Drug Administration
B. Clinical-Trial Sponsor
C. Contract Research Organizations
D. Study Monitors
E. Clinical-Trial Site
F. Site-Management Organizations
G. Institutional Review Board
H. Research Participants
5.8 Clinical Research Billing, Coding, and Documentation of Research Items and Services
A. Medicare’s NCD for Routine Costs in Clinical Trials
B. Requirements for Medicare Coverage For Routine Costs (Conditions for Qualifying Clinical Trials)
C. Qualification Process for Clinical Trials
D. Routine/Conventional Care Versus Customarily Provided Care
E. Methodology to Determine Coverage of a Clinical Trial: Coverage Analysis
F. Clinical Research Coding and Billing Adjudication
5.9 Industry Trade Organizations and Support Services
Recommended Reading

Chapter 6: Institutional Review Boards and Protection of Subjects in Clinical Research
Lori Nesbitt, Pharm.D., MBA
6.1 The Safety Net: The Web of Responsibilities That Minimizes Human Subjects’ Risks
6.2 The Beginning of Evolution of Ethical Principles of Clinical Research
6.3 Other Violations of the Rights of Human Subjects and the Ethical Principles Brought Forth
A. Tuskegee Syphilis Study: 1932–1972
B. Radiation Experiments: 1940s–1950s
6.4 Violations of the Rights of Human Subjects: Drug Studies
A. Thalidomide Use: 1956–1961
B. Willowbrook State School Study: 1960s
C. Hexamethonium: 2001
D. Gene Therapy: 1999
E. Dangers of Off-Label Therapy
6.5 Property Rights and the Human Body
A. Moore v. Regents of the University of California
B. Washington University v. Catalona
C. Henrietta Lacks
D. Genetic Property Rights and US Policy
6.6 Preventive Measures: Protecting Human Subjects
A. Why Do We Need Research Oversight?
B. Federal Agencies
C. Institutional Review Board
D. Informed Consent
E. Investigators’ Responsibilities
F. Serious and Unexpected Adverse Events
G. Subjects’ Responsibilities
H. Sponsors’ Responsibilities
I. Institutional Responsibilities
J. Ethical Dilemmas in Clinical Research and Subjects’ Safety
Appendix 6.1: Resources for Further Reading
Appendix 6.2: Examples of the Types of Questions That a Subject Should Ask the Investigator or Research Coordinator

Chapter 7: The Regulation of Drug Product Information to Consumers
Frank J. Ascione, Pharm.D., MPH, Ph.D. and Nithima Sumpradit, B.S.Pharm., M.A., Ph.D.
7.1 The Historical Development of FDA’s Regulatory Role
A. Early Phase (prior to 1906): No Significant Government Intervention
B. Early Regulatory Phase (1906–1938): Minimal Government Control
C. Greater Government Control (1938–1961)
D. Debating Increased Consumer Access to Drug Product Information (1962–1983)
E. Expanding Information Available to Consumers (1983–present)
7.2 Current State of Product-Related Information Provided to Consumers
7.3 Evolution of Drug Advertising to U.S. Consumers (DTCA)
7.4 Emergence of DTCA (1981–1982)
7.5 Voluntary Moratorium Period of DTCA (1983–1985)
7.6 Establishment of DTCA Regulations (1985–1999)
7.7 Current State of Direct to Consumer Advertising
7.8 Advantages and Disadvantages of DTCA
7.9 Conclusion

Chapter 8: Important Code of Federal Regulations Applicable to Drug Product Liability Suits
Compiled by S. Albert Edwards, Pharm.D., RAC, FRAPS.

Chapter 9: Counterfeit Drugs
Kimberly O’Donnell, BSME, MBA, PMP
9.1 Introduction and Definition
A. Scope of the Problem
B. Greatest Problems in the Poorest Parts of the World
9.2 Problem Increases in Industrialized Countries
9.3 Global and U.S. Pharmaceutical Market Sizes
9.4 Types of Drugs Most Likely to be Counterfeited
9.5 The Role of the Internet in the Growth of the Counterfeit Drug Business
9.6 Shutting Down Illegal Websites
9.7 Preventing Drug Counterfeiting
9.8 Legislative Measures in the U.S.
9.9 Enforcement Action for Counterfeiting
9.10 Understanding the Pharmaceutical Market Distribution Process
A. Step 1: API Creation
B. Step 2: Customs
C. Step 3: Repackaging
D. Step 4: Sale to Distributors
E. Step 5: Retail Pharmacy Dispense
9.11 Anti-Counterfeit Packaging
A. Overt Anti-Counterfeit Packaging
B. Covert Anti-Counterfeit Packaging
C. Forensic Anti-Counterfeit Packaging
D. Serialization/Track-and-Trace Anti-Counterfeit Packaging
E. 2010 Anti-Counterfeiting Measure Utilizing Cell Phones
9.12 Track-and-Trace Laws to Authenticate Drug Sources and Transactions
9.13 Shutting Down Illegal Websites
9.14 When FDA Approval is Required
9.15 Nanotechnology
9.16 E-Pedigree and RFID
A. Florida and California
B. Supply Chain Benefits
9.17 Conclusion
Recommended Reading
Appendix 9.1

Chapter 10: General Principles of Pharmacology
James J. O’Donnell III, M.S., Ph.D., James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., and Vanessa Juettner, M.S.
10.1 Introduction
10.2 Basic Principles
A. Absorption
B. Lipid Diffusion
C. Determinants of Absorption
1. Lipid/aqueous partition coefficient and pH
2. Bioavailability
3. First pass effect
10.3 Routes of Administration
10.4 Extravascular Administration
A. Oral Administration
B. Rectal Administration
C. Other Routes of Administration
10.5 Intravascular Administration
10.6 Distribution
A. Diffusion
B. Volume of Distribution
C. Binding to Plasma Proteins and Cellular Constituents
D. Re-Distribution
E. Blood-Brain Barrier (BBB)
F. Placental Barrier
G. Therapeutic Range
H. Bioequivalence vs. Bioinequivalence
10.7 Drug Metabolism (Biotransformation)
A. Phase I Reactions
1. The families of human P450s
2. Induction of P450 enzymes
3. P450 inhibition
B. Phase II Reactions
1. Metabolism of drugs to toxic products
10.8 Factors Affecting Drug Metabolism
A. Disease
B. Age
C. Gender
D. Genetic Factors
10.9 Drug Excretion
A. Urinary Excretion
1. Glomerular filtration
2. Tubular secretion (active secretion)
3. Tubular reabsorption
4. Effects of pH on urinary excretion of ionizable drugs
10.10 Pharmacokinetics
A. Introduction
B. Therapeutic Window and Therapeutic Index
C. Blood Levels for Narrow Therapeutic Index (NDI) Drugs
D. Kinetic Modeling
E. Drug Absorption and Elimination
1. Absorption rate
2. Elimination rate
3. Clearance (CL)
4. Area Under the Curve (AUC)
5. Elimination (k)
6. Elimination half-life
7. Steady state
F. Dosing
1. Loading dose
2. Maintenance Doses (MD)
3. Example: Dosage adjustment in renal impairment
G. Therapeutic Drug Monitoring (TDM)
H. Pharmacokinetics Summary
10.11 Drug Receptor and Pharmacodynamics
A. Agonists and Antagonists
B. Drug-Receptor Interactions
10.12 Dose Responses
A. Potency
B. Agonism and Antagonism
1. Partial agonists
10.13 Competitive Antagonism
10.14 Non-Competitive Antagonism
10.15 Conclusion

Chapter 11: The Role of Investigative Journalism in Improving Drug Safety
Martha Rosenberg
11.1 Introduction
11.2 Follow the Money
A. Doctor Largesse
B. Drug Reps and Off-Label Marketing
11.3 Questionable Marketing Tactics
A. Direct-to-Consumer Advertising: Selling diseases and symptoms
B. “Early intervention” to Sell Childhood Drugs
C. Ghostwriting—the Hidden Hand of Medical Communication Companies
D. CMEs Funded by Drug Companies
11.4 Conflicts of Interest (COIs) in Government
A. COIs in the Military
B. COIs in the FDA
11.5 COIs in Medical Groups and Associations
A. COIs at the AMA
C. COIs at the American Academy of Pediatrics
11.6 COIs in Published Research
A. A Decade of Questions over a Paxil Study
11.7 Clinical Trial Irregularities
11.8 Reimbursement Schemes
11.9 Drug Company Funded Patient Groups
11.10 Drug Case Studies
A. Bisphosphonates
B. Hormone Replacement
C. Vytorin
D. Statins
E. SSRIs and SNRIs
F. Lyrica
G. Seroquel
H. TNF Blockers
11.11 Conclusion

Chapter 12: Search and Analysis of the Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS)
Paul N. Danese, Ph.D.
12.1 Introduction
12.2 Background
A. Small Clinical Trial Populations
B. Narrow Patient Demographics
C. Tightly Regulated Co-Administration of Concomitant Medications
12.3 History of the FDA’s Drug Safety Surveillance Systems
12.4 Submission of Adverse Event Reports to the FDA
A. Mandatory Reports
B. Voluntary Reports
12.5 Adverse Drug Reaction Information Captured by the FAERS
12.6 Searching FAERS Data to Identify Possible Safety Problems
A. Statistical Methods to Identify Drug Safety Signals
B. Dechallenge and Rechallenge Data
C. Identifying Drug-Drug Interactions
D. Timelines and Deadlines of Adverse Event Reporting
12.7 The Food and Drug Administration’s Use of the FAERS in Regulatory Decisions
A. Boxed Warnings
B. Other Changes to a Medication’s Prescribing Information
C. Determinations that No Action is Needed and Continuing Investigations
12.8 Limitations of the FAERS
A. Lack of Demonstration of Causality for Individual Reports
B. Reporting Bias
C. Extensive Under-reporting
D. Lack of Comparator Populations (Lack of a Denominator)
12.9 Forthcoming Changes to the Adverse Event Reporting System
FDA’s Transparency Initiative
12.10 Search and Retrieval of Adverse Event Reports from the FDA’s FAERS
A. Raw Data Files
B. Open FDA Application Programming Interface
C. FOIA Request
D. Commercial Vendors
12.11 Other FDA Adverse Event Reporting Systems
C. Sentinel Initiative
12.12 Summary

Chapter 13: Consequences of Violations of DEA Controlled Substance Laws
Joseph J. Bogdan, Pharm.D., R.Ph., J.D.
13.1 Abstract
13.2 History and Mission of Drug Enforcement Admininstration
A. Health Care Providers
B. DEA Inspections
C. Legal Authority
13.3 Manufacturing and Distribution Controls on Controlled Substances
A. Chemical Control Program
13.4 DEA Definitions—Schedules
13.5 DEA Monitoring
A. ARCOS—Automation of Reports and Consolidates Orders System
B. PMP—Prescription Monitoring Program
C. DEA Targets
13.6 DEA Enforcement Actions
A. Pharmacy—PharMerica
B. Cases Against Physicians
1. Lawrence Adams, M.D.—Pittsburgh
2. Pankaj Agrawal, M.D.—Sicklerville, NJ
3. Edward J. Alexander, M.D.—Philadelphia
C. Manufacturers, Distributors, and Wholesalers
13.7 Conclusion

Part II: High Risk Drug Therapies Resulting in Injury and Litigation

Chapter 14: Allergic Drug Reactions
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph. and James J. O’Donnell III, M.S., Ph.D.
14.1 Adverse Drug Reactions (ADRs): How Large is the Problem? What Drugs are Involved? What are the Injuries?
A. Historical Perspective
B. ADR Incidence
C. FDA Reporting Requirements
D. The “Seven Deadly Sins”: Why Doctors Fail to Report ADRs
E. Attitudes Toward ADRs
F. Investigator Fraud
14.2 Classification of ADRs
A. Categories of ADRs
1. Type A reactions: Augmentation of the pharmacological response
2. Type B reactions: Bizarre (idiosyncratic)
14.3 Types of Drug Allergy and Hypersensitivity
A. The Nature of Drug Allergy
B. Dangerous Drug-Allergy Reactions
C. Drug Sensitivities Mimic Allergy Symptoms
D. Definitions of Allergic Reactions (Hypersensitivity)
E. Idiosyncratic Reactions
F. Intolerance
G. Toxicity
H. Hypersensitivity Vasculitis
I. Predominantly Organ-Specific Reactions
1. Dermatologic Manifestations
J. Urticaria
K. Fixed Drug Eruptions
L. Photosensitivity Reactions
M. Generalized Exfoliative Dermatitis
N. Thrombocytopenia
O. Hemolytic Anemia
P. Agranulocytosis
Q. Treatment: Withdrawal of the Suspected Drug
R. Symptomatic Treatment
S. Prevention of Allergic Drug Reactions
T. Pseudoallergy
U. Angioedema
V. Hypersensitivity Reactions
14.4 Risk Factors, Drugs and Patients
A. Hypersensitivity Risk Factors
B. Identification of a Drug Allergy
C. Penicillins and Cephalosporins
1. Sulfonamide allergic reactions and cross-sensitivity
D. Case Report: Cross-Allergencity
14.5 Erythema Multiforme, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis
A. Fixed Drug Eruptions
B. Erythema Multiforme-Like Eruptions
C. Fluoroquinolones
E. NSAIDs Cross Reactivity Case Report
F. Radiographic Contrast Media (RCM)
G. Local Anesthetics
H. Anticonvulsants
14.6 Conclusion

Chapter 15: Evaluation of Medical Causation
Donald H. Marks, M.D., Ph.D.
15.1 What is Causation?
15.2 Importance of Establishing Causation
15.3 Definitions
15.4 Degree of Adverse Effects Relate to Intervention
15.5 Methodology to Investigate Causation
15.6 Structured Algorithms for Determination of Causation
A. Hill Criteria—Expanded Discussion
1. Strength of association
2. Consistency of results
3. Specificity
4. Temporal relationship
5. Dose response
6. Biological plausibility
7. Biological coherence
8. Experimentation
9. Analogy
15.7 Comments on the Individual Riddell Criteria for Causation
15.8 Daubert and the Evolution of Causation
15.9 Does Causation Need to be Established Before a Warning is Given?
15.10 What are the Qualifications Needed to Give Causation Opinions?
15.11 Summary

Chapter 16: Addiction as Mitigation
Barry D. Hargan, M.S., MHA
16.1 Introduction
16.2 Clinical Variables which Contribute to the Onset of Addiction
A. Genetic Predispostion
B. Learned Behavior
C. Psychopathological Exposure
16.3 Substance- or Medication-Induced Mental Disorder
16.4 The Simplified Version of Neurobiology and the Addicted Brain
16.5 Cocaine
16.6 Expert Testimony Concerning Addictive Disorders
A. Role of the Addictions Expert
B. Some Testimony Experiences and the Limits of Opinions
C. Preparation
16.7 Additional Considerations Concerning Addiction Mitigation
A. Alcoholic Dementia or Delirium
B. Neuropsychological Evaluation
C. Substance Withdrawal
16.8 Summary and Conclusion

Chapter 17: Medication Errors
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., Patricia Iyer, MSN, RN, LNCC, and David M. Benjamin, Ph.D., FCLM, FCP
17.1 History and Overview
17.2 Medication Errors in Epidemic Proportions
17.3 Types of Medication Errors
17.4 Medication Use Process
17.5 System Errors
17.6 Which Drugs are Most Often Involved in Medication Errors
17.7 Vaccine Errors
17.8 How Has Modern Research Improved Therapeutics and Reduced Drug-Related Morbidity?
17.9 Systems for Medical Error Prevention
A. Electronic Prescribing
B. When Electronic Prescribing is Unavailable
C. Effective Drug Monitoring Systems
D. The Importance of Continuing Education
E. Reporting ALL Adverse Drug Events
17.10 Conclusion

Chapter 18: Fetal Drug Exposure
Damani Parran, Ph.D., DABT
18.1 Introduction
18.2 Critical Periods of Human Development and Susceptibility
18.3 Special Considerations of Drug Exposure During Pregnancy
18.4 Historical Human Developmental Toxicants
A. Thalidomide
B. Ethanol
C. Diethylstilbestrol
D. Retinoids
E. Cocaine
18.5 Developmental Toxicity of Prescription Drugs
A. Serotonin Reuptake Inhibitors and Serotonin-Noradrenalin Reuptake Inhibitors
B. Valproic Acid
C. Phenytoin
D. Warfarin
E. Benzodiazepines
18.6 Additional Prenatal Environmental Influences
A. Malnutrition
B. Poverty
C. Emotional State
D. Mother’s Age
E. Infections and Diseases
18.7 FDA Pregnancy Categories for Prescription Drug Labeling; Final Rule

Chapter 19: Acute Adverse Drug Events in Critical Care: Emergency Department and Intensive Care Units
Gourang Patel, Pharm.D., M.Sc., BCCCP, BCPS
19.1 Background
A. Epidemiology
B. Environment
19.2 High-Risk Medication-Related Events
A. Hypersensitivity Reactions
B. Cardiovascular Reactions
1. Blood pressure (BP)
2. Heart rate (HR)
3. Arrhythmias
C. Nephrotoxicity
1. Aminoglycosides
2. Amphotericin B
3. Intravenous contrast
D. Hypoglycemic Events
E. Infusion-Related Reactions
1. Extravasations
2. Propofol-related infusion syndrome (PRIS)
3. Intravenous N-acetylcysteine (NAC)
F. Reversal Agents
1. Protamine
2. Vitamin K
3. Naloxone
4. Flumazenil
19.3 Summary

Chapter 20: Antidepressants: Clinical Use and Litigation
Henry Cohen, B.S., M.S., Pharm.D., FCCM, BCPP, CGP and Marian James, Pharm.D., BCPS, CGP, FASCP
20.1 Major Depressive Disorders
20.2 Antidepressant Pharmacology
20.3 Antidepressant Overdose
20.4 Antidepressants and the Patient with Suicidal Ideation
A. Prozac and Suicidal Ideation
1. Woulfe v. Eli Lilly & Co.
2. Espinoza v. Eli Lilly & Co.
3. Cassidy v. Eli Lilly & Co.
B. Antidepressant and Increased Suicidality in Pediatrics
1. Schilf v. Eli Lilly & Co.
20.5 Broken Heart Syndrome: Tako Tsubo Cardiomyopathy Associated with Use of Antidepressants
20.6 The Adverse Effects of Antidepressants and the Duty to Warn
A. Docken v. Ciba-Geigy
B. Stebbins v. Concord Wrigley Drugs, Inc. et al.
C. Morgan et al. v. Wal-Mart Stores, Inc.
D. Kampmann v. Mason
E. Cottam v. CVS
20.7 Antidepressants and Alcohol
A. Kirk v. Michael Reese Hospital
B. Hand v. Krakowski
20.8 Selective Serotonin Reuptake Inhibitors and the Serotonin Syndrome
20.9 Hepatic Cytochrome P450 Drug Interactions and Cyclic Antidepressants
20.10 Antidepressants and Herbal Agents Drug Interactions
20.11 Serzone and Liver Disease
20.12 High Blood Pressure Associated with Venlafaxine Use
20.13 SSRI Use and Birth Defects
20.14 The Pharmacist’s Role
20.15 The Omnibus Budget Reconciliation Act
20.16 How Safe is it to Buy Prescription Medications Over the Internet?
20.17 In a Perfect World
20.18 Conclusion

Chapter 21: HIV Pharmacotherapy and Its Complications
Vincent Idemyor, Pharm.D.
21.1 Epidemic Overview
21.2 Use of Antiretroviral Therapy
C. PIs—Protease Inhibitors
D. Fusion Inhibitor
E. CCR5 Antagonist
F. Integrase Inhibitors
21.3 Complications of Anti-Retroviral Therapy
21.4 Conclusion

Chapter 22: Adverse Effects of Diabetic Drugs: Focus on Hypoglycemia
Gourang Patel, Pharm.D., M.Sc., BCCCP, BCPS, James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., and Vincent Marks, M.A., DM(Oxon), FRCP, FRCPath, MAE
22.1 Diabetes Demographics and Epidemiology
22.2 Insulin
22.3 Insulin Preparations
22.4 Clinical Use of Insulin
A. Dosing
22.5 Hypoglycemia (Low Blood Sugar)
A. Etiologies of hypoglycemia
B. Insulin-induced hypoglycemia
22.6 Pathophysiology and Clinical Symptoms of Hypoglycemia
22.7 Incidence
22.8 Pathophysiology and Biochemistry of Hypoglycemia
22.9 Adverse Reactions Involving Hypoglycemia
A. Case report: Insulin-related malpractice-sliding scale and urine sugars result in cardiac arrest
B. Insulin damages baby’s brain, pharmacist error suggested
C. Another interloper?
22.10 End Product Testing Recommended
22.11 Insulin Murders
22.12 Hypoglycemia from the Sulfonylurea Derivatives
22.13 Adverse Effects of the Sulfonylureas
22.14 Drug Interactions with Sulfonylureas
22.15 The Gliptin Class—New drugs for Diabetes Treatment Type 2 Diabetes
22.16 Thiazolidinediones
A. Hepatic Failure
B. Bladder Cancer
Takeda and Lilly Still Fighting
22.18 Summary and Conclusions

Chapter 23: Nephrotoxic Drugs
Domenic A. Sica, M.D. and Todd W. B. Gehr, M.D.
23.1 Introduction
23.2 Framework of the Problem
23.3 Basis for the Kidney Being Susceptible to Damage
23.4 Patient Groups Most Susceptible to Nephrotoxicity
23.5 Demographics of Chronic Kidney Disease
23.6 Methods to Assess Renal Function and Damage
23.7 Level of Renal Function at Which Drug Accumulation Occurs
23.8 Nephrotoxic Drugs
A. What Constitutes Prompt Clinical Action in the Face of Nephrotoxicity?
23.9 Nephrotoxicity Scenarios
A. Lithium Toxicity
B. Gentamicin
C. Dialysis-Related Issues
D. Drug Clearance in Relationship to Renal Failure
E. Angioedema With an Ace Inhibitor
F. Fatal Hyperkalemia With Medications
G. Statin Therapy and the Development of Myopathy
23.10 Conclusions

Chapter 24: Drug‑Induced Liver Disease
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., Donald H. Marks, M.D., Ph.D., Paul N. Danese, Ph.D., and James J. O’Donnell III, M.S., Ph.D.
24.1 Introduction: The Problem of Drug-Induced Liver Disease (DILD)
24.2 Adverse Drug Reactions Involving Hepatotoxicity
24.3 Overview of DILD: Epidemiology Risk Factors, Histopathology, and Diagnoses
A. Epidemiology of Drug Hepatotoxicity
B. Risk Factors
C. Histopathology
D. Diagnosis
24.4 Hepatic Drug Metabolism
24.5 FDA and DILD
24.6 Types of Liver Injury
A. Hepatitis
B. Massive Hepatic Necrosis (Fulminant Hepatitis)
C. Drug-induced Vanishing Bile Duct Syndrome
24.7 Specific DILD Product Areas and Case Discussions
A. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Use and Hepatoxicity
B. Isoniazid-Induced Hepatotoxicity
C. Acetaminophen
1. Acetaminophen toxicity assessment nomograms
2. FDA report: Acetaminophen induced liver disease
3. Acetaminophen legal cases
D. Macrolide Hepatotoxicity
E. Methotrexate (MTX)
F. Estrogens and Oral Contraceptive Steroids
G. Statins
H. Ticlopidine
I. ACE Inhibitors and AT II Receptor Antagonists
J. Fluoroquinolones
K. Terbinafine
L. Ketoconazole
M. Selective Serotonin Reuptake Inhibitors—Serzone Liver Toxicity
N. Herbal and Environmental Hepatotoxicity
24.7 Summary and Conclusions
Conclusions and Future Perspectives

Chapter 25: Anticoagulants: Therapeutics, Risks, and Toxicities
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.
25.1 Introduction
25.2 Summary of Anticoagulant Therapy
A. Definition
B. Use
1. Treatment of coronary heart disease
2. Warfarin and dabigatran
3. Treatment of thrombogenesis
25.3 Limitations of Current Therapy
A. Heparin
B. Low Molecular Weight Heparin (LMWH)
C. Heparin-Induced Thrombocytopenia (HIT)
1. Pathogenesis of the autoimmune response
2. Pathogenesis of the prothrombotic state
3. Clinical presentation of HIT
4. Diagnosis
5. Treatment of HIT
6. Conclusion
D. Warfarin
25.4 Monitoring Oral Anticoagulation
25.5 Alternatives to Warfarin—NOACs
A. Pradaxa (Dabigatran) vs. Warfarin
B. Antiplatelet Therapy
1. ASA
2. ADP inhibitors
25.6 Conclusion

Chapter 26: Drug-Induced Movement Disorders
Jadwiga Najib, B.S.,Pharm.D. and Meagan Bailey, M.D.
26.1 Introduction
26.2 Presentation
26.3 Agents Associated with Drug-Induced Movement Disorders
26.4 Risk Factors
26.5 Sequelae of Drug-Induced Movement Disorders
26.6 Theories of Causation
26.7 Drug-Induced Movement Disorders in Children and Adolescents
26.8 Drug-Induced Movement Disorders in the Elderly
26.9 Acute/Intermediate Drug-Induced Movement Disorders
A. Dystonia
1. Presentation
2. Implicated agents
3. Risks
4. Management
B. Ataxia
C. Bruxism
D. Neuroleptic Malignant Syndrome
E. Serotonin Syndrome
26.10 Chronic Drug-Induced Movement Disorders
A. Akathisia
1. Presentation
2. Implicated agents
3. Other drugs
4. Risks
5. Management
B. Parkinsonism
1. Presentation
2. Implicated agents
3. Other drugs
4. Risks
5. Management
C. Myoclonus, Tremor, Tics, Asterixis
26.11 Persistent/Tardive Drug-Induced Movement Disorders
A. Tardive Dyskinesia
1. Presentation
2. Implicated agents
3. Risks
4. Management
B. Tardive Akathisia
C. Tardive Dystonia
D. Other Tardive Variants
26.12 Drugs Used for Movement Disorders
26.13 Monitoring
26.14 Clinical and Legal Issues in Psychiatry
26.15 Conclusion

Chapter 27: Dangers of Opiates
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph. and James J. O’Donnell III, M.S., Ph.D.
27.1 Introduction
A. Definition
B. History
C. Cultivation
27.2 Pharmacology of Opioids
A. Effects
B. Opioid Neural Receptors
1. Central nervous system (CNS) receptors
2. Peripheral nervous system (PNS) receptors
C. Routes of Administration
1. Oral
2. Intramuscular
3. Subcutaneous
4. Intravenous
5. Transdermal
6. Sublingual and buccal
7. Neuroaxial
D. Excretion
27.3 Toxicity of Opioids
A. Respiratory Depression
B. Symptoms of Overdose
C. Epidemiology of Opioid Abuse
27.4 Case Reports: Opioid Pharmacology and Toxicity Causing Respiratory Arrest, Brain Damage, and Death
A. Case Report: Respiratory Arrest and Brain Damage Following Morphine Overdose in the Hospital
B. Case Report: Fentanyl Epidural Respiratory Arrest
C. Case Report: Duragesic (Fentanyl) Death in Discharged Patient
D. Case Report: High Dose Fentanyl Patch Prescribed in Opiate-Naïve Patient—Death
E. Case Report: Heroin and Other Opiates
F. Case Report: Dilaudid Respiratory Arrest
27.5 Methadone Special Kinetics and Case Report
A. Methadone Use and Treating Chronic Pain
B. Adverse Effects of Methadone
C. Respiratory Depression
D. Equianalgesia
E. Drug Interactions
F. Cardiovascular Effects
G. Consequences of Ignorance for Proper Dosing of Methadone
H. Methadone Legal Case Examples Involving Patient Demise
I. Summary: Applying Lessons Learned and Action for Institutional Committees
27.6 Conclusion

Chapter 28: Drug-Induced Aggression and Violence
Peter D. Anderson, Pharm.D., BCPP, CMI-IV
28.1 Classification of Aggression
28.2 Causes of Aggression
A. Neurobiology of Aggression
B. Medical and Psychiatric Causes of Aggression
28.3 The Role of Drugs as a Cause of Violence
A. History of Drug Defenses
B. Problems with the Literature
C. Epidemiological Studies
28.4 Specific Drugs or Drug Classes that Cause Aggression
A. Ethanol (Alcohol)
B. Lysergic Acid Diethylamide (LSD)
C. Phencyclidien and Ketamine
D. Anabolic Steroids
E. Insulin and Hypoglycemia
F. Psychostimulants
G. Benzodiazepines
H. Selective Serotonin Reuptake Inhibitors
I. Varenicline
28.5 The Drug-Induced Insanity Defense
28.6 Conclusion

Chapter 29: Drug-Induced Falls
James J. O’Donnell III, M.S., Ph.D. and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.
29.1 Introduction
29.2 The Definition of Fall
29.3 Epidemiology
29.4 Causes and Risk Factors
A. Physiological Risk Factors for Falls in the Elderly
B. Psychological Risk Factors
C. Medications
29.5 Medication-Related Fall
29.6 Types of Medications Which Increase the Risk of Fall
A. Centrally Active Medications
B. Benzodiazepines
C. Antipsychotics
D. Antihypertensives
1. Orthostatic hypertension and risk of falls
E. Opioids
29.7 Marijuana
29.8 Alcohol
29.9 Hip Fractures
29.10 Polypharmacy
29.11 Fall Risk Assessment
29.12 Types of Assessments
29.13 Strategies for Fall Prevention in Institutionalized Settings
A. Screening
B. Address the Risk Factors
1. Monitoring patients
2. Environmental interventions
3. Educational programs
4. Reducing fall injury
C. Discharge planning
D. Dissemination of Evidence in Reducing Injuries from Falls: Awareness and Intervention Works!
29.14 Conclusion

Chapter 30: Geriatric Medication Misadventures
Rodney G. Richmond, R.Ph., M.S., CGP, FASCP and James C. Norris, Ph.D., D.A.B.T., ERT
30.1 Introduction
A. Outpatient Medication Use
B. Hospital Medication Use
C. Long-Term Care Medication Use
30.2 Altered Clinical Response to Drugs
A. Pharmacokinetics
B. Pharmacodynamics
C. Multiple Comorbidities
D. Drug Interactions
30.3 Preventable Drug-Related Problems
A. Polypharmacy
B. Transitions of Care
C. Inadequate Monitoring
D. Potentially Inappropriate Medication Use
30.4 Legal Cases Application
30.5 Conclusion

Chapter 31: Ketorolac Abuse and Injury in College Athletics
Laura M. Plunkett, Ph.D., DABT
31.1 Synopsis
31.2 Introduction
31.3 Pharmacology of NSAIDs Including Ketorolac
A. What is Ketorolac?
B. Overview of Eicosanoid Biology
C. Ketorolac Mechanism of Action
31.4 What Are the Benefits of Using Ketorolac?
31.5 What Are the Risks of Using Ketorolac?
A. Cardiovascular Risks of Ketorolac
B. Gastrointestinal Toxicity and Bleeding Risks of Ketorolac
31.6 Regulatory Actions Related to NSAID Cardiovascular Events
31.7 Ketorolac Risks and Use in College Athletics
31.8 Ketorolac in College Sports and Informed Consent

Part III: Pharmacists, Pharmacy and Pharmacy Practice

Chapter 32: Pharmacy Practice and Manufacturers in a Post-ACA, Managed Care Environment
F. Randy Vogenberg, R.Ph., Ph.D. and Rita Marcoux, R.Ph., MBA
32.1 Managed Care
32.2 Specialty Pharmacy and Payor Changes
32.3 Certification
32.4 Credentialing and Accreditation for Pharmacies or Pharmacists
32.5 Current and Near Future Issues in Pharmacy Practice
32.6 Landscape of Pharmacy Practice: The Changing Marketplace
32.7 College of Pharmacy, Life Long Learning, and Certification
32.8 Pharmacy Support Personnel, and Certification or Registration
32.9 Continuing Professional Education Pharmacist and Support Personnel
32.10 Professional Practice Settings
32.11 The Pharmacist Professional versus Pharmacy Business
32.12 Issues for Pharmacy in the Near Future
32.13 Pharmaceutical Wholesaler
32.14 The Pharmaceutical Industry: Marketplace Description and Changes
32.15 Manufacturers: Research-Intensive, Biotechnology, and Generic Segments
32.16 Pharmaceutical Manufacturer Customers: Contracting Beyond the Prescriber
A. Organization and Operations
B. Other Targeted Customer and Class of Trade Segments
32.17 Contracting and Change in the Pharmaceutical Industry
32.18 Health Care Industry Changes in the Near Future
32.19 Summary

Chapter 33: Pharmacogenomics: Using Precision Medicine to Decrease Adverse Drug Reactions
Vincent Idemyor, Pharm.D.
33.1 Introduction
33.2 Pharmacogenomics as a Translational Science
A. Oncology
B. Infectious Diseases
C. Cardiovascular Diseases
D. Severe Cutaneous Adverse Drug Reactions
E. Mental Health
33.3 Genomic Medicine—Future Expectations

Chapter 34: Regulation of Pharmacy Practice
Ned Milenkovich, Pharm.D., J.D.
33.1 Introduction
A. Pharmacy as a Self-Governing Profession
33.2 Licensure of Professional Activities
A. Boards of Pharmacy—A Closer Look
B. National Association of Boards of Pharmacy
33.3 Practice Standards
A. Legally Circumscribing Pharmacy Practice
33.4 Licensure Process To Practice Pharmacy
A. Licensing
B. Licensing of Pharmacists
33.5 The Different Types of Pharmacy Licenses
A. Disciplinary Actions
B. Causes of Disciplinary Action
C. Practice Focus on Licensure
D. Ongoing Professional Education
E. Support Personnel
33.6 Federal Drug Laws
A. OBRA ‘90
B. Medicare
C. Medicare Part D
D. Medicaid
E. Prescription Drug Coverage
F. Fraud, Waste and Abuse
G. 340B Drugs
H. Pharmacy Compounding
33.7 Pharmacy Practice: Putting It All Together
A. Pharmacy Practice: An Ongoing Progression
B. Collaborative Practice Agreements
C. Drug Utilization Review (DUR)
D. Other Mandates Impacting Pharmacy Practice Quality Assurance Regulations
E. Health Insurance Portability and Accountability Act of 1996, as amended

Chapter 35: Pharmacist Malpractice and Liability
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph. and David M. Benjamin, Ph.D., FCLM, FCP
35.1 Introduction
35.2 The Science of Risk Management
35.3 The Pharmacists Mutual Claims Study
A. Most Common Error: Wrong Drug
1. The “sound-alike” and look alike problem (S_A_L_A_D)
2. Physician’s handwriting
B. Wrong Drug Strength: Another Common Error
C. Third in Line: Wrong Directions
D. Lack of Drug Review
E. Counseling: A Powerful Weapon Against Liability
1. California lawsuits against CVS and Walgreens
2. Rite Aid settles patient consultation lawsuit
F. Non-Bodily Injury
1. Judge rules pharmacists comments to patient privileged, and therefore a defense for a slander suit
G. Miscellaneous Errors
1. Compounding Errors
2. Home Health Care Pharmacist Monitoring
3. NECC: Pharmacy compounding explodes into the news
35.3 The CNA Claims Study (CNA/HPSO)
A. CNA Database and Methodology
B. Most Common Categories of Errors
C. Analysis of Claims by Insurance Source and Licensure Type
D. Factors Affecting Wrong Drug Dispensing Errors
E. Wrong Dose
F. Wrong Directions
G. Lack of Drug Review
H. Drugs Involved in Errors
I. Discussion – CAN Claims Study
35.4 Avoiding Errors and Malpractice
35.5 Specific Pharmacist Malpractice Reports and Topics
A. Duty to Warn?
B. 18 Year Old Boy Brain Damaged by Over Prescribing: Prescribers and Pharmacist Sued
C. Mail-Order Pharmacies
D. Quotas and Metrics: Contributing to the Problem?
E. Pharmacist’s Responsibility Regarding Recalls
F. Methotrexate (MTX) Errors
G. Criminal Charges Against Pharmacies
35.6 Steps Toward a Better Outcome
35.7 Conclusion

Chapter 36: Pharmacy Case Law Review
Roger N. Morris, R.Ph., J.D. and William J. Stilling, R.Ph., M.S., J.D.
36.1 Administrative Law
A. Due Process–Pharmacist Licensure
1. Berjikian, et al. v. Franchise Tax Board et al., No. CV 13–06301 DDP, 2015 WL 1185472 (C.D. Cal. March 12, 2015)
36.2 Antitrust
A. State Regulatory Boards Immunity
1. North Carolina Bd. of Dental Examiners. v. Federal Trade Commission, 135 S. Ct. 1101 (Feb. 25, 2015)
36.3 Civil Procedure
A. Spoliation of evidence–Pharmacy’s Duty to Maintain Evidence of Misfill
1. Burton v. Walgreen Co., 2015 WL 4228854 (D. Nev. July 10, 2015)
36.4 Conscientious Objection
A. Emergency Contraception
1. Stormans, Inc. v. Wiesman, 794 F.3d 1064 (9th Cir. 2015)
36.5 Controlled Substances
A. Duty to Verify DEA Registration
1. Farmacia, Yani, 80 Fed. Reg. 29,053 (May 20, 2015)
2. JM Pharmacy Group Inc., d/b/a/ Farmacia Nueva and Best Pharma Corp., 80 Fed. Reg. 28,667 (May 19, 2015)
B. Constitutionality
1. McFadden v. United States, 135 S. Ct. 2298 (June 18, 2015)
36.6 Criminal
A. Violations of Pharmacy Law Applied to Non-pharmacists
1. Moore v. State of Florida, NO. 1D14-3527, 2015 WL 4464689 (Fla. Dist. Ct. App. July 21, 2015), reh’g denied (Sept. 1, 2015)
B. PMP Records
1. Lundy v. State, 26 N.E.3d 656 (Ind. Ct. App. Feb. 20, 2015)
C. Second Degree Murder
1. U.S. v. Barry J. Cadden, et al., 2014 WL 7151586 (D. Mass. Dec. 16, 2014)
36.7 Defamation
A. Physician against Pharmacist
1. LeFrock v. Walgreen Co., 77 F. Supp.3d 1199 (M.D. Fla. Jan. 16, 2015)
B. Duty to Fill
1. Kadambi v. Express Scripts, 2015 WL 475373 (N.D. Ind. February 5, 2015)
36.8 Employment
A. Discrimination (Pregnancy)
1. Torres-Skair v. Medco Health Solutions, Inc., 595 F.App’x 847 (11th Cir. Dec., 4, 2014)
B. Employment at Will
1. Hoven v. Walgreen Co., 751 F.3d 778 (6th Cir. June 2, 2014)
C. Americans with Disability Act
1. Stevens v. Rite Aid Corp., et al., 6:13-cv-00783 (N.D.N.Y., September 23, 2015)
D. Overtime Class Action
1. Baugh v. CVS Health, et al., 2:15-cv-00014 (E.D. Penn., July 27, 2015)
E. Medical Marijuana
1. Coats v. Dish Network, 350 P. 3d, 849 (Colo. June 15, 2015)
36.9 Fraud and Abuse
A. False Claims
1. United States v. Express Scripts, Inc., 602 F. App’x 880 (3rd. Cir. Feb. 20, 2015)
B. False Claims–Generic Substitutions
1. Doe v. Houchens Indus., Inc., No. 1:13-CV-00196-RLY, 2015 WL 133706 (S.D. Ind. Jan. 9, 2015)
C. False Claims & Anti-Kickback Statute
1. U.S. ex rel. Kester v. Novartis Pharm. Corp., No. 11 CIV. 8196 CM, 2015WL 1650767 (S.D.N.Y. Apr. 10, 2015)
D. Consumer Fraud
1. City of Chicago v. Purdue Pharma L.P., 2015 WL 2208423 (N.D. Ill. May 8, 2015)
36.10 Negligence
A. Duty to Provide Medication
1. Davies v. Virginia CVS Pharmacy, LLC, et al., 7:14-CV-00175, 2014 WL 6460787 (W.D. Va. Nov. 17, 2014)
B. Duty Not to Dispense
1. Oleckna v. Daytona Disc. Pharmacy, 162 So. 3d 178 (Fla. Dist. Ct. App. 2015)
36.11 Privacy
A. Patient Privacy–Vicarious Liability
1. Walgreen Co. v. Hinchy, 25 N.E.3d 748 (Ind. Ct. App. Jn. 15, 2015) reh’g of, 21 N.E.3d 99 (Ind. Ct. App. Nov. 14, 2014)
B. Text Messages
1. Thompson v. CVS Pharmacy, Inc., 6:204-cv-02081 (M.D. Fla. Dec. 19, 2014)
C. Robocalls
1. Kolinek v. Walgreen Co., 2014 WL 3056813, (N.D. Ill. July 7, 2014)
36.12 Product Liability
A. Learned Intermediary Doctrine
1. Watts v. Medicis Pharm. Corp., 342 P.3d 847 (Ct. App. 2015), review granted in part (Sept. 22, 2015)
B. Product Liability (applicability to pharmacists)
1. Randol Mill Pharmacy v. Miller, 465 S.W.3d 612 (Tex. 2015), reh’g denied (Sept. 11, 2015)

Chapter 37: The Pharmacist’s Utilization of the National Patient Safety Goals to Contribute to Safe and Effective Medication Use
Jennifer Splawski, Pharm.D., BCPS and Heather Minger, Pharm.D., BCPS
37.1 Introduction
A. Overview of ‘The Goals’
37.2 Goal 3 and the Pharmacist’s Role
A. NPSG.03.05.01 Relating to Anticoagulation
1. Introduction
2. Warfarin overview
3. Patient monitoring
4. Patient education
5. Medical home
6. Novel oral anticoagulants
B. NPSG.03.06.01 Relating to Reconciling Medication Information
1. Introduction
2. The process of medication reconciliation
3. Improved accuracy
4. Decreased mortality
5. Allergy identification
6. Discharge medication reconciliation
37.3 Goal 7 and the Pharmacist’s Role
A. NPSG.07.03.01 Relating to Hospital Born Health-Care Associated Infections
1. Introduction
2. Pharmacy personnel training
3. Pharmacist role in antimicrobial stewardship
B. NPSG.07.05.01 Relating to the Prevention of Surgical Site Infections
1. Introduction
2. Surgical Care Improvement Project (SCIP)
37.4 Summary

Chapter 38: Pharmacy Compounding Regulations
Loyd V. Allen, Jr., B.S., M.S., Ph.D.
38.1 Introduction
38.2 Food and Drug Administration
38.3 1997–2013 Food and Drug Modernization Act of 1997 (FDAMA)
38.4 2013–Onward: Events Leading up to HR3204
38.5 Background Related to H.R. 3204 Drug Quality and Security Act
38.6 H.R. 3204, 503A Pharmacies
38.7 H.R. 3204, 503B Outsourcing Facilities
38.8 The “Triad”
38.9 Licensed Pharmacist or Physician
38.10 Anticipatory Compounding
38.11 Substances that May be Used in Compounding
38.12 Substances that May Not be Used in Compounding
38.13 Memorandum of Understanding (MOU)
38.14 Definitions of Compounding
38.15 Implementation of H.R. 3204—Draft Guidances
38.16 Implementation of H.R. 3204—Organization and Lists
A. Organization
B. Lists to Develop
38.17 U.S. Pharmacopeia
A. Chapter <795>: “Pharmaceutical Compounding—Nonsterile Preparations”
B. Chapter <797>: “Pharmaceutical Compounding—Sterile Preparations”
C. Chapter <1160>: “Pharmaceutical Calculations in Prescription Compounding”
D. Chapter <1163>: “Quality Assurance in Pharmaceutical Compounding”
E. Chapter <800>: Hazardous Drugs— Handling in Healthcare Settings (Proposed)
F. USP Compounding Compendium
38.18 Individual Drug Monographs
38.19 National Association of Boards of Pharmacy (NABP)
38.20 Pharmacists’ Responsibilities
38.21 Marketed But Not FDA-Approved Drugs
Appendix 38.1 List of Drugs that were Withdrawn or Removed from the Market for Safety Reasons

Chapter 39: The Imperative for After Hours Pharmacy Services in U.S. Hospitals
Christopher A. Keeys, B.S., Pharm.D., BCPS, RPh
39.1 Introduction
39.2 Twenty-Four/Seven Healthcare: The After-Hours Pharmacy Gap
39.3 Scope of Pharmacy Services in U.S. Hospitals
39.4 Select Trends in Medication Use and Pharmacy Services
39.5 After-Hours Pharmacy Service Models
39.6 Service Models for After-Hours Pharmacy in U.S. Hospitals
39.7 Nighttime Medication Errors
39.8 Medication Reconciliation and Afterhours Care
39.9 Pharmacy Technology and After-Hours Services
39.10 Standards Setting and After-Hours Pharmacy Services
39.11 Medication Use and Interdisciplinary Roles
39.12 Changing Roles of the Pharmacy Technician
39.13 Research and Education Needs

Part IV: Forensic and Toxicology Issues: Recreational Drugs, Drug Testing, and Pain Equipotency

Chapter 40: Forensic Criminal Analysis of Insulin and Sulfonylureas
Vincent Marks, M.A., DM(Oxon), FRCP, FRCPath, MAE
40.1 Introduction
40.2 Criminal Behavioral Changes Resulting from Hypoglycemia
Case 1
40.3 Non-Hypoglycemia
40.4 Hypoglycemia versus Neuroglycopenia
40.5 Was it Neuroglycopenia?
Case 2
40.6 Neuroglycopenic (Hypoglycemic) Automatism and Driving
40.7 Driving and Neuroglycopenia
40.8 Negligence
Case 3
Case 4
Case 5
40.9 Factitious Hypoglycemia
40.10 Malicious Insulin Administration
Case 6
40.11 Non-Selective Malicious Insulin Usage
Case 7
40.12 Use of Anti-Diabetic Drugs as Targeted Murder Weapons
40.13 Victim Alive When Found
Case 8
Case 9
40.14 Estimation of Nature, Dose and Time of Administration of Hypoglycemic Agent
40.16 Victim Found Dead
40.15 Was it Insulin?
40.17 Suspicion of Malicious Insulin or Sulfonylurea Use
40.18 Other Forensic Applications of Anti-Diabetic Drugs
40.19 Conclusion

Chapter 41: The Forensic Pharmacist
Peter D. Anderson, Pharm.D., BCPP, CMI-IV and James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.
41.1 Introduction
41.2 Consultant and Expert Witness
41.3 Pharmacist Malpractice
41.4 Interpreting Drug Levels
41.5 Malpractice Cases of Other Professionals
41.6 Criminal Cases
41.7 Utilization Review for Insurance Claims
41.8 Workers’ Compensation
41.9 Alcohol Cases
41.10 Drug-Induced Violence and Aggression
41.11 Pain Assessment
41.12 Experience, Background, and Skills of the Forensic Pharmacist
41.13 Sample Forensic Pharmacist’s Reports
A. Affidavit: May 2010—Morphine and Miranda
B. Affidavit: November 2003
C. Affidavit: June 2010
D. Affidavit: April 15, 2005
41.14 Conclusion

Chapter 42: Forensic Drug Testing
James J. O’Donnell III, M.S., Ph.D., James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., and Anne D. ImObersteg, M.S., J.D., MBA, B.A.
42.1 Introduction
42.2 The Screening Test
A. Immunoassays
B. Thin Layer Chromatography (TLC)
C. Case Report: False Positive Opiate from Pastry Poppy Seed Consumption
D. Case Report: Positive Cocaine Urine Drug Test—Cause of Accident
42.3 Extraction of the Drug from the Biological Matrix
42.4 The Instruments
B. Quantifying a Drug Using the GC/MS
D. The LC/MS
42.5 Sources of Instrumental Error
42.6 Prevention Against and Detection of Drug Test Cheating
42.7 Types of Errors
42.8 Discovery
A. Sample Collection
B. Standard Operating Procedure
1. Testing and certification
2. Screening test
3. Confirmation
42.9 Summary
Recommended Reading

Chapter 43: Drug Testing in the Workplace
James J. O’Donnell III, M.S., Ph.D., James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., and Anne D. ImObersteg, M.S., J.D., MBA, B.A.
43.1 Introduction
43.2 Non-Regulated Testing
43.3 Regulated Testing
43.4 Voluntary Programs
43.5 Establishment of a Workplace Program
A. Written Policy
B. Employee Assistance Programs
C. Employee Awareness Training
D. Supervisor Training
E. Drug Testing
43.6 The Drug-Testing Process
A. Collection
B. Accessioning
C. Drugs to Be Tested
D. Initial Test-Immunoassay Testing
E. Confirmation Tests
F. Reporting and Storage of Samples
43.7 Additional Program Aspects
A. The Medical Review Officer (MRO)
B. Public Interest Exclusions (PIE)
C. Blind Performance Testing
D. Alcohol Testing
43.8 Special Drug-Testing Issues
A. Type of Matrix
1. Hair testing
2. Saliva testing
3. Sweat testing
4. Blood
5. Urine
B. Alternate Sources of Drug Exposure
C. Amphetamine Testing Issues
D. Medical Use of Drugs
43.9 Legal Aspects of Workplace Drug-Testing
A. Constitutional Issues
B. State and Federal Mandates
43.10 Discovery: The “Litigation Package”
43.11 Conclusions

Chapter 44: The Emergency Department Pharmacist
Victor Cohen, B.S., PharmD, BCPS, CGP, RPhI, Samantha P. Jellinek-Cohen, Pharm.D., BCPS, CGP, and Megan Musselman, Pharm.D., M.S., BCPS, BCCCP
44.1 Introduction
44.2 Epidemiology of Drug Injury and Contributing Risk Factors
A. Contributing Risk Factors
44.3. Etiology and Sources of Drug Injury in the ED
44.4 Clinical Pharmacy in the ED: A Historical Perspective
44.5 The ED Pharmacist Plays a Dual Role at Maimonides Medical Center
44.6 The ED Pharmacist: A Sub-Specialist in Emergency Medicine
A. Training and Education
B. Certification
44.7 The ED Pharmacist as a Generalist
44.8 The ED Pharmacist Ensuring Optimal Continuum of Care
A. The ED and Infectious Diseases
B. The ED Pharmacist and the Ambulatory Care Interphase
C. The ED Pharmacist and Transitions of Care (TOC)
1. Medication admission notes in the ED
D. The ED Pharmacist as a Clinical Toxicology Consultant
E. The ED Pharmacist and the Cardiology Interface
F. The ED Pharmacist and Neurological Emergencies
G. The ED Pharmacist and Pulmonary Emergencies
H. The ED Pharmacist and Public Health Services in the ED
44.9 Building Layers of Defense Against Drug Injury
A. Detecting and Preventing Drug Injury in the ED
B. The ED Pharmacist and Community Surveillance for Adverse Drug Reactions
44.10 Pharmacy Practice in the ED: Pharmacotherapy Specialty
44.11 Conclusion

Chapter 45: Pain Equipotency
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph.
45.1 Treatment of Chronic Nonmalignant Pain
A. Diagnostic Evaluation of Pain
B. Evaluation of Chronic Pain
C. Neuropathic Pain
D. Suffering and Pain Behavior
45.2 Pain Equipotency
A. Introduction
B. Experimental and Clinical Pain
C. Clinical Pain
D. Pain Studies
E. Therapeutic Trials
F. Treatment of Pain
G. Goodman and Gilman Discussion of Morphine
H. Analgesia
I. Types of Pain
1. Myocardial infarction (heart attack) crushing pain of chest and arm
2. Labor pain
J. Oral Analgesic Medication Studies
K. Conclusion

Chapter 46: Postmortem Redistribution and Interpretation of Drug Levels
Gourang Patel, Pharm.D., M.Sc., BCCCP, BCPS
46.1 Abstract
46.2 Introduction
46.3 Review of a Case File
46.4 Postmortem Considerations
A. Physiologic Changes in the Body After Death
B. Drug Characteristics
46.5 Analysis of Drug Level Information
46.6 Summary

Chapter 47: Alcohol
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph. and James J. O’Donnell III, M.S., Ph.D.
47.1 Introduction
47.2 Alcohol Injury Epidemiology
47.3 Alcohol Intoxication Effects in Litigation
47.4 Differences Between Civil Litigation Involving Alcohol and Criminal Litigation (DUI)
47.5 Settings for Alcohol Related Litigation
A. Employment
47.6 Police Activities
A. Police Pursuit
B. Excessive Police Force
47.7 Motor Vehicle Collisions
A. Vehicle-Vehicle
B. Motorcycle Cases
C. Boating
D. Vehicle-Pedestrian
47.8 Alcohol and Fall Risk
A. No Alcohol Test—Fall on Bar Stairs
B. Residential Stairs Fall
C. Tripped on Threshold—Sued Condominium Association
47.9 Family Law—Custody Use of Alcohol Biomarkers (EtG)
A. Family Law—Restrictions on Child Visitation Based on Alleged Continued Alcohol Abuse
47.10 Conclusion

Chapter 48: Cocaine
James C. Norris, Ph.D., D.A.B.T., ERT and Rodney G. Richmond, R.Ph., M.S., CGP, FASCP
48.1 Historical Background
48.2 Medical Usages of Cocaine
48.3 Illegal Usages of Cocaine
48.4 Routes of Administration
48.5 Effects of Cocaine
48.6 Psychotic Disorders Induced by Cocaine
48.7 Tolerance
48.8 Withdrawal or Abstinence Effects
48.9 Mechanisms of Action
48.10 Metabolism
48.11 Blood Levels
48.12 Urine Levels
48.13 Impairment
48.14 Associated Deaths with Cocaine Usage
48.15 Conclusion

Chapter 49: Marijuana: Pharmacology and Medical-Legal Issues
James T. O’Donnell, Pharm.D., M.S., FCP, ABCP, FACN, R.Ph., James J. O’Donnell III, M.S., Ph.D., and David M. Benjamin, Ph.D., FCLM, FCP
49.1 Introduction
49.2 Federal Law vs. State Law
A. Harrison Narcotics Tax Act
B. Comprehensive Drug Abuse Prevention and Control Act
C. Marijuana Drug Laws at State Level
1. Legalization
2. Decriminalization
3. Controlled prescription and distribution of medical marijuana
4. Variability in regulation and content uniformity
49.3 The Pharmacology and Toxicology of Δ9-tetrahydrocannabinol (THC)
A. Source, Active Compounds
B. Kinetics—How THC is Absorbed Into the Body
C. Pharmacodynamics—Where THC Works in the Body—Site of Action
D. Cannabidiol
C. Routes of Administration for Marijuana
49.4 Marijuana Safety
A. Serious Adverse Effects
B. Risk of Addiction
C. Effect on Brain Development
D. Long Term Behavioral Effects
1. Age of onset of use
2. Relationship of intoxication and route of administration—smoking or edible
49.5 Conclusion
Appendix 49.1

Chapter 50: Marijuana-Impaired or Just Cannabinoid Positive?
John P. Bederka, Jr., Ph.D.
12.1 Cannabinoid positive: After Smoking
A. Introductory Summary
B. Key Questions
C. Scientific Data Relating to THC
1. Blood THC v. brain THC: any relationships?
2. Relationships between percent plant-THC and plasma-THC
3. Relation between degree of “High” and plasma THC
4. Occasional marijuana users v. practiced users
5. Is THC the only psycho-active cannabinoid?
6. Urine testing for cannabinoids: clinical or evidentiary value?
7. Impairment & marijuana: laboratory and on-road data
D. Conclusions
12.2 Under the Influence: After Ingestion
A. Introductory Summary
B. Some Comparative Data on Smoking and Ingesting Cannabis
1. How do bioavailability measures relate to ingestion?
2. Is Dronabinol administration a good model for cannabis Ingestion?
3. Any overall advantages of the oromucosal route?
4. Can the effects after ingestion of cannabis be made more objective?
C. Conclusions


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