Pharmacy Practice and the Law

by Richard R. Abood, Kimberly A. Burns, Frederick Frankhauser

Overview

Pharmacy Practice and the Law, Tenth Edition not only helps students prepare for their upcoming board exam, but also urges them to understand and critically analyze the law that governs both the profession and the products they distribute. With the most up-to-date federal, legal, regulatory, and policy developments, as well as new developments to various medical and pharmaceutical programs, the Tenth Edition provides a comprehensive overview with an accessible, student-friendly writing style.

Product Details

ISBN-13:	9781284280135
Publisher:	Jones & Bartlett Learning
Publication date:	11/02/2023
Edition description:	10th ed.
Pages:	400
Sales rank:	630,871
Product dimensions:	8.53(w) x 10.88(h) x 0.74(d)

About the Author

Richard Abood received a B.S. in Pharmacy from the University of Nebraska in Lincoln and a Juris Doctorate degree from the same institution. He has worked in both community and hospital pharmacy practice. He holds the title of Professor Emeritus in Pharmacy Practice at the University of the Pacific where he was Professor of Pharmacy Practice for 23 years. Previously he was Professor of Pharmacy Administration at the University of Wyoming and concurrently served for several years as the Executive Director and legal counsel for the Wyoming Pharmaceutical Association. Professor Abood has given numerous presentations and authored several publications in the areas of pharmacy and health care law.In 2000 the American Society for Pharmacy Law presented him the President’s Award for his cumulative achievements in pharmacy law. In 2002 the University of the Pacific awarded him the Eberhardt Teacher/Scholar Award, Pacific’s highest honor for excellence in combined teaching and scholarship. In 2013 Pacific presented him the Order of the Pacific, its highest honor for a career of distinguished teaching, scholarship, and service. Professor Abood has been active in several state and national pharmacy organizations. He has served as president and board member of the San Joaquin Pharmacists Association; and as president and board member of the American Society for Pharmacy Law. Professor Abood has regularly served as a consultant on pharmacy law issues to law firms, state and federal governments, and pharmacy organizations.

Kimberly Burns is a Professor at the Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy, located in Erie, PA.She received her B.S. in Pharmacy from the University of Pittsburgh School of Pharmacy (cum laude) and her Juris Doctor degree from Duquesne University Law School (cum laude).She is both a licensed pharmacist and attorney in Pennsylvania. Kim has been a professor at the LECOM School of Pharmacy since 2002.Her teaching responsibilities include Pharmacy Law and Ethics and an elective advanced practice rotation site at the Erie County Department of Health, where she primarily contributes to local prescription drug abuse efforts.In addition to her academic career, she practiced community pharmacy for over 15 years and has consulted on various legal cases regarding pharmacy law issues. She has also written a number of papers and commentaries, and has made presentations at the local, state, and national level on a variety of pharmacy law topics. Professor Burns has been active in several state and national pharmacy organizations, including the American Society of Pharmacy Law where she served as board member and president.Professor Burns has also been recognized with various awards for her leadership and contributions to community service, research, and teaching.

Table of Contents

	Preface	ix
Chapter 1	The Law and The Legal System	1
	Chapter Objectives	1
	Nature and Role of Law	2
	Sources of U.S. Law	5
	The Legislative Process	10
	Distinguishing Criminal, Civil, and Administrative Law	12
	The Judicial Process	12
	Federal Verses State Law	19
	Case Studies	21
Chapter 2	Federal Regulation of Medications: Development, Production, and Marketing	37
	Chapter Objectives	37
	Historical Overview of the Federal Food, Drug, and Cosmetic Act	38
	Defining and Distinguishing Drugs from Foods, Devices, and Cosmetics	42
	Prohibited Acts, Penalties, and Enforcement	51
	Adulterated Drugs	54
	Misbranded Drugs	56
	New Drug Approval	63
	Generic Drugs as New Drugs	68
	Drugs Intended to Treat Serious and Life-Threatening Diseases	71
	Voluntary Reporting Programs	72
	Medical Device Act (Amendments) of 1976	73
	Cosmetics	74
	Drug Advertising and Promotion	75
	Case Studies	83
Chapter 3	Federal Regulation of Medications: Dispensing	101
	Chapter Objectives	101
	Durham-Humphrey Amendment	102
	Approved Drugs for Unlabeled Indications	111
	Pharmacy Compounding Versus Manufacturing	112
	The Orange Book	116
	Prescription Drug Marketing Act of 1987	119
	Inspections under the Federal Food, Drug, and Cosmetic Act	122
	Use of Alcohol in Pharmacy Practice	123
	Poison Prevention Packaging Act	123
	Drug Advertising by Pharmacies	126
	Case Studies	129
Chapter 4	The Closed System of Controlled Substance Distribution	145
	Chapter Objectives	145
	State Versus Federal Authority	146
	Classification of Controlled Substances	147
	Authority for Scheduling	149
	Manufacturer Labeling and Packaging	150
	Registration	150
	Security Requirements	158
	Penalties	159
	Pharmacy Inspections	161
	Opioid Treatment Programs	166
	Laws Related to the Controlled Substances Act	168
	Case Studies	170
Chapter 5	Dispensing Controlled Substances	185
	Chapter Objectives	185
	Prescriptions	185
	Recordkeeping	200
	Drug Enforcement Administration Order Form 222	206
	Case Studies	211
Chapter 6	Federal Regulation of Pharmacy Practice	227
	Chapter Objectives	227
	The Omnibus Budget Reconciliation Act of 1990	227
	Health Insurance Portability and Accountability Act of 1996	233
	Medicare	240
	Medicaid	243
	Medicare/Medicaid Fraud and Abuse Statute	246
	Federal Regulation of Long-Term Care	248
	Federal Antitrust Laws	251
	Case Studies	261
Chapter 7	State Regulation of Pharmacy Practice	275
	Chapter Objectives	275
	Self-Regulation in Pharmacy	275
	A Different World	276
	Approaches to Regulation	277
	State Board of Pharmacy	278
	Licensing	279
	Actions Against a License	281
	Actions Against a Pharmacy License	284
	Standards of Practice	285
	State Hospital Pharmacy Licensure Issues	288
	State Regulation of Long-Term Care	289
	State and Judicial Regulation of Third-Party Plans	290
	Regulation for Outcomes	293
	Case Studies	295
Chapter 8	Pharmacist Malpractice Liability and Risk Management Strategies	313
	Chapter Objectives	313
	Legal Procedure	314
	The Malpractice Action	314
	Liability for Failure to Perform Expanded Responsibilities	323
	Risk Management Strategies	330
	The Pharmacist as Risk Manager	334
	Malpractice Insurance	337
	Drug Product Liability	337
	Case Studies	345
	Table of Cases	365
	Index	371

Editorial Reviews

4 Stars! from Doody

This reference book on pharmacy law is designed for use by faculty teaching pharmacy law courses as a textbook to guide the students through the various aspects and applications of law. The purpose is to provide an overview of pharmacy law in the U.S. This book is intended for use primarily by students and faculty involved in pharmacy law coursework. It is of some value to the practicing pharmacist who would like to review specific applications of the law. This edition has been condensed from 16 chapters into eight. The first five are an introduction to the law, the Food Drug and Cosmetic Act, and the Controlled Substance Act. In the next chapter the authors focus on the federal influences that impact the practice of pharmacy (e.g. OBRA, Medicare, Medicaid). In the seventh chapter they describe the state responsibilities in regulating pharmacy and in the final chapter they discuss malpractice issues. There are summary cases at the end of each chapter, designed to promote lively discussion in the classroom. They are particularly helpful in illustrating various interpretations of the law. This reference is well written and extremely valuable to faculty teaching students pharmacy law. The authors clearly have a great depth and breadth of experience in this area and have incorporated many changes based on feedback from those using this reference in coursework. The cases have been added to this edition to stimulate critical thinking by the students and embrace the educational philosophy of the American Association of Colleges of Pharmacy. Using the cases in a classroom setting, students can learn to understand that pharmacy law is not always black-and-white.

Mary Lynn Moody

This book attempts to describe all the legal and ethical issues a pharmacy student needs to know. The purpose is to provide a framework for learning the federal and some state laws and rules pertaining to pharmacy and its special area. This book is needed and the author's objectives are met. This book is intended for students in colleges of pharmacy and clearly meets the needs of the intended audiences. The coauthors are very credible authorities on the subjects. Very few tables, graphs, charts, or illustrations appear in the book, and more could be added. The references and the ethics section are of great value. The table of cases and the table of contents are very good. The chapter objectives serve as a valuable tool to the classroom instructor. This would be a great addition to the libraries of the pharmacy law student and faculty member. The overall outline and subsequent flow make the text useful in the classroom. The case index and ethics section are highly useful to advanced students and continuing education programs.

Toby G. Clark

Overviews criminal, civil, and administrative law as it applies to pharmacy practice. This third edition includes new case studies and discussion questions, and contains updated material on new regulations and changes in pharmacy law and practice. Content has been revised to correspond with recent directives launched by the American Association of Colleges of Pharmacy. Abood teaches pharmacy practice at the University of the Pacific's School of Pharmacy. Brushwood teaches pharmacy health care administration at the College of Pharmacy at the University of Florida. Annotation c. Book News, Inc., Portland, OR (booknews.com)

Booknews

Reviewer: Patrick J. McDonnell, PharmD (Temple University School of Pharmacy)
Description: Now in its ninth edition, this is a comprehensive overview of the laws that govern pharmacy presented in a useful format. This edition comes with a code for an accompanying online resource with an ebook version with activities to practice, assess, and analyze the material covered in the book.
Purpose: The purpose is to provide a resource to teach pharmacy students and, in my opinion, practicing pharmacists, about pharmacy laws as well as how to analyze them in assessments. When I refer to practicing pharmacists, I mean those who are licensed in one state but may need to transfer their license to another state, which at times means having to take another law exam (which often incorporates more than just a state's specific legal practice). Presenting the material in print and online gives students options for what works best for them.
Audience: As noted, the book is written primarily for pharmacy students, but it could also serve as a reference for practicing pharmacists seeking a user-friendly, comprehensive resource on pharmacy law. The authors are both pharmacists and lawyers who combine their backgrounds to produce a reference without legal jargon.
Features: The book presents a broad overview of how law permeates the practice of pharmacy. An introduction to legal basics segues into the history of the federal regulation of medications with very detailed chapters on controlled substances. It also covers other legal aspects of how the federal government has an influence on state regulation of practice. One chapter that was nicely written was the final one on medical practice and how it intertwines with pharmaceutical care activity and the practice of pharmacy. The book is free of legal jargon and uses case examples and summaries of key points to help readers understand and apply the information. As a pharmacy educator, I can certainly see how the case studies could stimulate a robust in-class discussion or be used as an assignment to assess a student's ability to comprehend and apply the material.
Assessment: Other pharmacy law books I've reviewed have either been simple practice questions with very little explanation and certainly not as in depth as this one, or just more of a list of the laws without case study examples and key point summaries. Having an accompanying website is fairly unique for a book on pharmacy law.

Doody's Review Service