Pharmacy Practice and the Law

by Abood, Richard R.; Brushwood, David B.

• ISBN13: 9780834218802
• ISBN10: 0834218801
• Edition: 3rd
• Format: Paperback
• Copyright: 2000-08-01
• Publisher: Jones & Bartlett Pub

Summary

Univ. of the Pacific, Stockton, CA. Second author, David B. Brushwood, is with Univ. of Florida, Gainesville. Textbook, for pharmacy students, features key case studies, updated material covering new regulations and changes in practice, and revised content to correspond with recent directives launched by the American Association of Colleges of Pharmacy. Prev. ed: c1997. Softcover.

Table of Contents

Preface	ix
The Law and the Legal System	1	(36)
Chapter Objectives	1	(1)
Nature and Role of Law	2	(3)
Sources of United States Law	5	(6)
The Legislative Process	11	(2)
Distinguishing Criminal, Civil, and Administrative Law	13	(1)
The Judicial Process	13	(7)
Case Studies	20	(17)
Federal Regulation of Medications: Development, Production, and Marketing	37	(65)
Chapter Objectives	37	(1)
Historical Overview of the Federal Food, Drug and Cosmetic Act	37	(6)
Defining and Distinguishing Drugs from Foods, Devices, and Cosmetics	43	(8)
Prohibited Acts, Penalties, and Enforcement	51	(3)
Adulterated Drugs	54	(2)
Misbranded Drugs	56	(7)
New Drug Approval	63	(5)
Generic Drugs as New Drugs	68	(3)
Drugs Intended To Treat Serious and Life-Threatening Diseases	71	(1)
Voluntary Reporting Programs	72	(1)
Medical Device Act (Amendments) of 1976	73	(1)
Cosmetics	74	(1)
Drug Advertising and Promotion	75	(8)
Case Studies	83	(19)
Federal Regulation of Medications: Dispensing	102	(47)
Chapter Objectives	102	(1)
Durham-Humphrey Amendment	103	(9)
Approved Drugs for Unlabeled Indications	112	(1)
Pharmacy Compounding versus Manufacturing	113	(5)
The ``Orange Book''	118	(2)
Prescription Drug Marketing Act of 1987	120	(3)
Inspections under the Federal Food, Drug and Cosmetic Act	123	(1)
Federal Alcohol Taxation	123	(1)
Poison Prevention Packaging Act	124	(2)
Drug Advertising by Pharmacies	126	(4)
Case Studies	130	(19)
The Closed System of Controlled Substance Distribution	149	(39)
Chapter Objectives	149	(1)
State versus Federal Authority	150	(1)
Classification of Controlled Substances	151	(2)
Authority for Scheduling	153	(1)
Manufacturer Labeling and Packaging	154	(1)
Registration	154	(8)
Security Requirements	162	(1)
Penalties	163	(2)
Inspections under the Controlled Substances Act	165	(4)
Narcotic Treatment Programs	169	(1)
Laws Related to the Controlled Substances Act	170	(2)
Case Studies	172	(16)
Dispensing Controlled Substances	188	(50)
Chapter Objectives	188	(1)
Prescriptions	188	(15)
Recordkeeping	203	(11)
Drug Enforcement Administration Order Form 222	214	(5)
Case Studies	219	(19)
Federal Regulation of Pharmacy Practice	238	(42)
Chapter Objectives	238	(1)
The Omnibus Budget Reconciliation Act of 1990	239	(6)
Medicare	245	(3)
Medicaid	248	(3)
Federal Regulation of Long-Term Care	251	(3)
Federal Antitrust Laws	254	(10)
Medicare/Medicaid Fraud and Abuse Statute	264	(1)
Safe Harbor Regulations	264	(1)
Case Studies	265	(15)
State Regulation of Pharmacy Practice	280	(39)
Chapter Objectives	280	(1)
Self-Regulation in Pharmacy	280	(1)
A Different World	281	(1)
Approaches to Regulation	281	(2)
State Board of Pharmacy	283	(1)
Licensing	284	(2)
Actions against a License	286	(4)
Standards of Practice	290	(3)
State Hospital Pharmacy Licensure Issues	293	(2)
State Regulation of Long-Term Care	295	(1)
State Legislative Efforts To Regulate Third-Party Plans	296	(2)
Regulation for Outcomes	298	(2)
Case Studies	300	(19)
Pharmacist Malpractice Liability and Risk Management Strategies	319	(48)
Chapter Objectives	319	(1)
Legal Procedure	320	(1)
The Malpractice Action	320	(8)
Liability for Failure To Perform Expanded Responsibilities	328	(8)
Risk Management Strategies	336	(5)
The Pharmacist as Risk Manager	341	(3)
Malpractice Insurance	344	(1)
Case Studies	345	(22)
Table of Cases	367	(4)
Index	371