Pharmacy Practice and the Law / Edition 5

Pharmacy Practice and the Law / Edition 5

by Richard R Abood
Pub. Date:
Jones & Bartlett Learning

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Pharmacy Practice and the Law / Edition 5

Pharmacy Practice and the Law, Fourth Edition is an easy-to-read law resource for pharmacy students and faculty. Extensively updated, this edition includes an overview of the law and legal system to provide a context to understand federal and state pharmacy regulation, as well as an analysis of such laws to stimulate critical thinking. The text highlights issues central to current pharmacy practice, including malpractice liability, risk management, and product liability; and includes end-of-chapter case studies. This edition of Pharmacy Practice and the Law also provides a current and accessible explanation of new federal and state pharmacy regulations that reflect the recent directives of the American Association of Colleges of Pharmacy. Supplemented by specific state and federal pharmacy laws and drug regulations, this text allows students to better understand the role of pharmacy and pharmacists in today's health care system.

Product Details

ISBN-13: 9780763749781
Publisher: Jones & Bartlett Learning
Publication date: 08/28/2007
Edition description: 5E
Pages: 440
Product dimensions: 6.80(w) x 9.90(h) x 0.90(d)

Table of Contents

Chapter 1The Law and The Legal System1
Chapter Objectives1
Nature and Role of Law2
Sources of U.S. Law5
The Legislative Process10
Distinguishing Criminal, Civil, and Administrative Law12
The Judicial Process12
Federal Verses State Law19
Case Studies21
Chapter 2Federal Regulation of Medications: Development, Production, and Marketing37
Chapter Objectives37
Historical Overview of the Federal Food, Drug, and Cosmetic Act38
Defining and Distinguishing Drugs from Foods, Devices, and Cosmetics42
Prohibited Acts, Penalties, and Enforcement51
Adulterated Drugs54
Misbranded Drugs56
New Drug Approval63
Generic Drugs as New Drugs68
Drugs Intended to Treat Serious and Life-Threatening Diseases71
Voluntary Reporting Programs72
Medical Device Act (Amendments) of 197673
Drug Advertising and Promotion75
Case Studies83
Chapter 3Federal Regulation of Medications: Dispensing101
Chapter Objectives101
Durham-Humphrey Amendment102
Approved Drugs for Unlabeled Indications111
Pharmacy Compounding Versus Manufacturing112
The Orange Book116
Prescription Drug Marketing Act of 1987119
Inspections under the Federal Food, Drug, and Cosmetic Act122
Use of Alcohol in Pharmacy Practice123
Poison Prevention Packaging Act123
Drug Advertising by Pharmacies126
Case Studies129
Chapter 4The Closed System of Controlled Substance Distribution145
Chapter Objectives145
State Versus Federal Authority146
Classification of Controlled Substances147
Authority for Scheduling149
Manufacturer Labeling and Packaging150
Security Requirements158
Pharmacy Inspections161
Opioid Treatment Programs166
Laws Related to the Controlled Substances Act168
Case Studies170
Chapter 5Dispensing Controlled Substances185
Chapter Objectives185
Drug Enforcement Administration Order Form 222206
Case Studies211
Chapter 6Federal Regulation of Pharmacy Practice227
Chapter Objectives227
The Omnibus Budget Reconciliation Act of 1990227
Health Insurance Portability and Accountability Act of 1996233
Medicare/Medicaid Fraud and Abuse Statute246
Federal Regulation of Long-Term Care248
Federal Antitrust Laws251
Case Studies261
Chapter 7State Regulation of Pharmacy Practice275
Chapter Objectives275
Self-Regulation in Pharmacy275
A Different World276
Approaches to Regulation277
State Board of Pharmacy278
Actions Against a License281
Actions Against a Pharmacy License284
Standards of Practice285
State Hospital Pharmacy Licensure Issues288
State Regulation of Long-Term Care289
State and Judicial Regulation of Third-Party Plans290
Regulation for Outcomes293
Case Studies295
Chapter 8Pharmacist Malpractice Liability and Risk Management Strategies313
Chapter Objectives313
Legal Procedure314
The Malpractice Action314
Liability for Failure to Perform Expanded Responsibilities323
Risk Management Strategies330
The Pharmacist as Risk Manager334
Malpractice Insurance337
Drug Product Liability337
Case Studies345
Table of Cases365

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