Pharmacy Law Desk Reference

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ISBN: 9780789018229 | 0789018225
Cover: Nonspecific Binding
Copyright: 11/29/2006

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Today's practicing pharmacist is faced with legal, ethical, and moral concerns in making the transition from traditional pharmacy practice to an ever-expanding role in clinical pharmacy practice and patient medication therapy management. Pharmacy Law Desk Reference is a primer on the legal aspects of pharmacy practice, providing background on foundation legal concepts, and guidance on the Federal Food, Drug, and Cosmetic Act (FFDCA), the Controlled Substances Act (CSA), and the Federal Trade Commission (FTC). This unique book examines the major topics that impact pharmaceutical care, including professional liability insurance; the need for supportive personnel in pharmacy practice; patent law, trademarks, and copyrights; law and ethics; business low, labor and employment law; HIPAA privacy in the pharmacy; electronic prescribing, and medication error reporting. Book jacket.

About the Editor

xiii

Contributors

Foreword

xvii

Joseph G. Valentino

Preface

xix

Delbert D. Konnor

The Function, Evolution, and Historical Development of the Law

(16)

Martha M. Rumore

Government Organization and Function

(1)

Agency Organization and Function

(2)

The Court System

(3)

Order of Precedence of Authority

(1)

Enactment of Legislation

(2)

Code of Federal Regulations

(5)

Secondary Sources of the Law

(1)

Appendix: Electronic Resources

(3)

Forms of Business Organization

(8)

Francis B. Palumbo

George E. Rippel Jr.

Introduction

(1)

Forms of Organization

(6)

Piercing the Corporate Veil

(1)

Conclusion

(1)

Federal Food, Drug, and Cosmetic Act

(16)

Larry R. Pilot

Introduction

(2)

History

(2)

Food and Drug Administration

(5)

Surveillance, Enforcement, and Resolution

(1)

Department of Justice, Civil Division

(1)

Provisions of FFDCA Directly Applicable to Pharmacists and Pharmacies

(3)

Summary

(3)

The Pharmacist's Responsibility Under the Controlled Substances Act and Related Matters

(60)

Delbert D. Konnor

Background

(1)

Schedules of Controlled Substances

(2)

Registration Requirements

(4)

Disposal of Controlled Substances

(5)

Security Requirements

(4)

Record-Keeping Requirements

(2)

Change of Business Address

(1)

Affidavit for Renewal of Retail Chain Pharmacy Registration

(1)

Prescription Order Requirements

(6)

Prescription Monitoring Programs

(1)

Prescription Records

(1)

Inventory Requirements

(2)

Ordering Controlled Substances

(4)

Dispensing Requirements

(7)

Long Term Care Facilities

(1)

Controlled Substance Distribution by a Pharmacy

(1)

Narcotics for Patients with Terminal Illnesses of Intractable Pain

(1)

Narcotic Treatment Programs

(1)

U.S. Postal Service Mailing Requirements for Controlled Substances

(1)

Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations

(1)

Chemical Requirements: Comprehensive Methamphetamine Control Act of 1996

(4)

Pharmacists' Guide to Forged, Altered, and Stolen Prescription Blanks

(3)

Appendix: DEA Field Offices with Diversion Program Managers

(8)

Principles of Professional Liability Insurance for Pharmacists

101

(24)

Kenneth R. Baker

Overview

101

(4)

Underwriting

105

(3)

Professional Pharmacy Liability Coverage

108

(1)

Reading a Professional Liability and Commercial Policy

109

(11)

Conclusion

120

(5)

Patent Law, Trademarks, and Copyrights

125

(26)

Martha M. Rumore

Trade Dress

125

(1)

Patents

126

(13)

Trademarks

139

(3)

Nonpatent Protection

142

(1)

143

(8)

Pharmacy Trade Regulation

151

(22)

Richard A. Feinstein

Daniel A. Kotchen

Antitrust Laws

151

(7)

Antitrust Law Enforcement Mechanisms and Penalties

158

(3)

Antitrust Enforcement in the Pharmaceutical Industry

161

(5)

Minimizing Antitrust Risk

166

(2)

Consumer Protection Laws

168

(5)

Administrative Law

173

(32)

Sharon Horn Roddan

Introduction

173

(1)

The Need for Administrative Tribunals

173

(1)

Separation of Powers

174

(1)

Delegation of Legislative Power

175

(1)

Due Process Hearing Requirement

175

(2)

The Right To and Adequacy of Notice

177

(3)

The Process of Administrative Adjudication

180

(25)

Professional Practice Acts

205

(14)

Norman A. Campbell

Establishing the Practice Parameters

205

(1)

General Provisions of a Pharmacy Practice Act

206

(1)

The Board of Pharmacy

207

(1)

Additional Provisions of the Act

208

(1)

Pharmacist Licensing Requirements

209

(2)

License Renewal

211

(1)

Pharmacy Technicians

212

(1)

Licensing Entities

213

(3)

Board Sanctions Against Licenses

216

(3)

Labor and Employment Law

219

(22)

Roger N. Morris

Sandra J. Creta

Introduction

219

(1)

Employment Contracts

219

(2)

Duties Owed to the Employer

221

(2)

Civil Rights Laws

223

(5)

The Hiring Process

228

(2)

Wage and Hour Laws

230

(3)

Employee Rights

233

(3)

Termination of Employment

236

(5)

Taxation

241

(10)

Jacqueline A. Henson

Introduction

241

(1)

General Theories of and Types of Taxation

241

(1)

Constitutional Considerations

242

(1)

U.S. Taxation Overview

243

(1)

Federal Income Tax

243

(5)

Social Security Tax

248

(1)

Other Federal Taxes

248

(1)

State Income Tax

249

(1)

City and County Tax

249

(2)

Contracts

251

(20)

Jacqueline E. Artinger

Requirements of a Contract

252

(1)

Anatomy of a Sample Contract

253

(17)

Summary

270

(1)

Crimes and Torts

271

(10)

Norman A. Campbell

Crimes

271

(1)

Torts

272

(2)

Negligence

274

(1)

Issues for Consideration

275

(2)

Some Defenses

277

(4)

Agency

281

(8)

Norman A. Campbell

Parties to an Agency Relationship

281

(2)

Appointment Process

283

(1)

Duties of the Parties

284

(1)

Agency Termination

285

(4)

The Interface Between Law and Ethics in Pharmacy Practice

289

(20)

Margaret L. Eaton

Introduction

289

(1)

The Limitations of Law As an Ethical Guide

289

(6)

Sources of Ethics Codes and Guidelines

295

(4)

Basics of Ethical Reasoning

299

(7)

Conclusion

306

(3)

HIPAA Privacy in the Pharmacy

309

(30)

Brian A. Gallagher

What Is HIPAA?

309

(3)

What Information Does HIPAA protect?

312

(1)

Other Privacy Laws

312

(1)

Notice of Privacy Practices

313

(3)

Treatment versus Marketing

316

(2)

Minimum Necessary

318

(1)

Additional Patient Rights

319

(4)

Responsibilities of Covered Entities

323

(1)

Educating the Public About HIPAA

324

(1)

Recognized Entities Under HIPAA

325

(1)

State Privacy Laws versus HIPAA

326

(1)

When PHI May Be Disclosed

327

(4)

Limited Exceptions to the HIPAA Privacy Rule

331

(4)

Complying with HIPAA in Pharmacy Transactions

335

(1)

Consequences of Noncompliance

336

(3)

Medicare and Medicaid

339

(14)

Susan C. Winckler

Medicare

339

(5)

Medicaid

344

(4)

Impact of Medicare and Medicaid Payor Policy

348

(1)

Conclusion

349

(4)

Certification in Pharmacy: Advanced-Level Credentials, Including Specialty Certification

353

(28)

Richard J. Bertin

Introduction

353

(1)

Council on Credentialing in Pharmacy

354

(1)

Six Essential Definitions

355

(1)

Importance of Credentials in Pharmacy

356

(1)

Overview of Credentialing in Pharmacy

357

(1)

Advanced Practice Credentials for Pharmacists

357

(8)

Pharmacy Supportive Personnel (Technicians)

365

(2)

Certification---The Future

367

(1)

Appendix A: Glossary

367

(3)

Appendix B: Referenced Pharmacy Organizations and Certification Bodies

370

(3)

Appendix C: Specialties Recognized by the Board of Pharmaceutical Specialties

373

(3)

Appendix D: Council on Credentialing in Pharmacy---Guiding Principles for Pharmacy Credentialing Activities

376

(5)

Collaborative Drug Therapy Management

381

(22)

Marla J. Campbell

History of Pharmacist Prescribing and Collaborative Drug Therapy Management in the United States

381

(4)

Definitions of CDTM by Different Pharmacy Organizations

385

(4)

Requirements for Collaborative Drug Therapy Management

389

(14)

Supportive Personnel in Pharmacy Practice

403

(20)

Thomas George

Historical Perspective

403

(2)

Scope of Practice

405

(6)

Regulation

411

(2)

Training

413

(2)

Liability Issues

415

(1)

Exclusionary Activities

415

(1)

Malpractice and Other Liabilities

416

(1)

Malpractice Actions

417

(3)

Conclusion

420

(3)

Quality Improvement Initiatives for Pharmaceutical Care

423

(22)

Garry Carneal

Introduction

423

(1)

Measuring Quality Improvement Is an Ongoing Challenge

423

(2)

The Accreditation Movement

425

(7)

The Role of Regulatory Oversight

432

(3)

Pharmaceutical-Based Accreditation/Certification Programs

435

(6)

Conclusions

441

(4)

Electronic Prescribing

445

(22)

F. Nicholas Willard

Introduction

445

(1)

Electronic Prescribing: Benefits and Operational Characteristics

446

(4)

Electronic Commerce Law

450

(3)

Impact on Pharmacy Law: Electronic Prescription Orders and Electronic Signatures

453

(2)

State Law Requirements of Prescription Orders

455

(7)

Electronic Prescription Orders for Controlled Substances

462

(2)

Conclusion

464

(3)

Telepharmacy: Identifying Legal Issues for Pharmacists

467

(24)

Edward D. Rickert

Melissa A. Madigan

Introduction

467

(2)

Licensure

469

(6)

Conflicts of Law

475

(4)

Electronic Transmission of Prescription Information

479

(3)

The Validity of the Prescription Order and the Physician-Patient Relationship

482

(2)

Health Information Privacy and Security

484

(1)

Other Legal Issues

485

(3)

Conclusion

488

(3)

Medication Error Reporting

491

(16)

Jennifer Devine

Introduction

491

(1)

Medication Error Reporting Programs

492

(2)

Legal Liability for Medication Error Reporting

494

(4)

The Institute of Medicine

498

(2)

Patient Safety Legislation

500

(3)

Conclusion

503

(4)

VIPPS™: Creating a New Regulatory Model for the Internet Age

507

(14)

Carmen A. Catizone

Moira Gibbons

Historical Background

507

(3)

The VIPPS™ Program

510

(1)

VIPPS™ Certification Process

511

(2)

New Regulatory Strategy

513

(1)

Conclusion

514

(1)

Appendix A: Abbreviated List of Rogue Online Pharmacies with Notes

515

(1)

Appendix B: VIPPS™ Criteria

516

(5)

Index

521

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Pharmacy Law Desk Reference

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