Pharmacy Law Desk Reference

Pharmacy Law Desk Reference

ISBN-10:
0789018225
ISBN-13:
9780789018229
Pub. Date:
11/28/2006
Publisher:
Taylor & Francis
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Overview

Pharmacy Law Desk Reference

Your primary source for information on the legal issues of pharmaceutical practice, care, and activity

Today’s pharmacist is faced with legal, ethical, and moral concerns in making the transition from traditional pharmacy practice to an expanded role in clinical pharmacy and patient drug management services. Pharmacy Law Desk Reference is a primer on the legal aspects of pharmaceutical practice, providing background on foundational legal concepts, and guidance on the Food, Drug, and Cosmetic Act (FDCA), the Controlled Substances Act (CSA), and the Federal Trade Commission. 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 law; HIPAA privacy in the pharmacy; electronic prescribing; and medication error reporting. Handy tables, figures, and exhibits make complex information easy to access and understand.

The better pharmacists understand the regulatory and legislative framework that shapes their practice, the better they will be able to carry out their responsibilities to patients. Pharmacy Law Desk Reference offers a broad scope on established legal subjects, the current direction of the profession, and important contemporary topics that affect the clinical role of the practicing pharmacist. Each chapter is authored by a nationally recognized authority on one or more aspect of pharmacy law and many of the contributors are active in the American Society of Pharmacy Law.

Topics addressed in Pharmacy Law Desk Reference include:

  • telepharmacy
  • collaborative drug therapy management
  • trade secrets and trade secret protection
  • anti-competitive practices
  • the threat of civil and criminal liability
  • the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
  • FDA inspections
  • consumer protection laws
  • credentialing
  • pharmacy compounding
  • accreditation
  • employment contracts
  • Medicaid and Medicare
  • controlled substance registration and prescription orders
  • forged prescription orders
  • and many more
Pharmacy Law Desk Reference is a comprehensive resource on the professional, legal, and contemporary issues in pharmacy practice. It is a primary reference guidebook for pharmacy practitioners, leaders of state and national pharmacists associations, members of state boards of pharmacy, educators and students, and an essential addition to all pharmacy libraries.

Product Details

ISBN-13: 9780789018229
Publisher: Taylor & Francis
Publication date: 11/28/2006
Edition description: New Edition
Pages: 582
Product dimensions: 5.90(w) x 8.20(h) x 1.40(d)

Table of Contents

About the Editor
Contributors
Foreword (Joseph G. Valentino)
Preface (Delbert D. Konnor)

Chapter 1. The Function, Evolution, and Historical Development of the Law (Martha M. Rumore)
Government Organization and Function
Agency Organization and Function
The Court System
Order of Precedence of Authority
Enactment of Legislation
Code of Federal Regulations
Secondary Sources of the Law
Appendix: Electronic Resources

Chapter 2. Forms of Business Organization (Francis B. Palumbo and George Rippel, Jr.)
Introduction
Forms of Organization
Piercing the Corporate Veil
Conclusion

Chapter 3. Federal Food, Drug, and Cosmetic Act (Larry R. Pilot)
Introduction
History
Food and Drug Administration
Surveillance, Enforcement, and Resolution
Department of Justice, Civil Division
Provisions of FFDCA Directly Applicable to Pharmacists and Pharmacies
Summary

Chapter 4. The Pharmacist's Responsibility Under the Controlled Substances Act and Related Matters (Delbert D. Konnor)
Background
Schedules of Controlled Substances
Registration Requirements
Disposal of Controlled Substances
Security Requirements
Record-Keeping Requirements
Change of Business Address
Affidavit for Renewal of Retail Chain Pharmacy Registration
Prescription Order Requirements
Prescription Monitoring Programs
Prescription Records
Inventory Requirements
Ordering Controlled Substances
Dispensing Requirements
Long Term Care Facilities
Controlled Substance Distribution by a Pharmacy
Narcotics for Patients with Terminal Illnesses of Intractable Pain
Narcotic Treatment Programs
U.S. Postal Service Mailing Requirements for Controlled Substances
Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations
Chemical Requirements: Comprehensive Methamphetamine Control Act of 1996
Pharmacists' Guide to Forged, Altered, and Stolen Prescription Blanks
Appendix: DEA Field Offices with Diversion Program Managers

Chapter 5. Principles of Professional Liability Insurance for Pharmacists (Kenneth R. Baker)
Overview
Underwriting
Professional Pharmacy Liability Coverage
Reading a Professional Liability and Commercial Policy
Conclusion

Chapter 6. Patent Law, Trademarks, and Copyrights (Martha M. Rumore)
Trade Dress
Patents
Trademarks
Nonpatent Protection
Copyright

Chapter 7. Pharmacy Trade Regulation (Richard A. Feinstein and Daniel A. Kotchen)
Antitrust Laws
Antitrust Law Enforcement Mechanisms and Penalties
Antitrust Enforcement in the Pharmaceutical Industry
Minimizing Antitrust Risk
Consumer Protection Laws

Chapter 8. Administrative Law (Sharon Horn Roddan)
Introduction
The Need for Administrative Tribunals
Separation of Powers
Delegation of Legislative Powers
Due Process Hearing Requirement
The Right To and Adequacy of Notice
The Process of Administrative Adjudication

Chapter 9. Professional Practice Acts (Norman A. Campbell)
Establishing the Practice Parameters
General Provisions of a Pharmacy Practice Act
The Board of Pharmacy
Additional Provisions of the Act
Pharmacist Licensing Requirements
License Renewal
Pharmacy Technicians
Licensing Entities
Board Sanctions Against Licenses

Chapter 10. Labor and Employment Law (Roger N. Morris and Sandra J. Creta)
Introduction
Employment Contracts
Duties Owed to the Employer
Civil Rights Laws
The Hiring Process
Wage and Hour Laws
Employee Rights
Termination of Employment

Chapter 11. Taxation (Jacqueline A. Henson)
Introduction
General Theories of and Types of Taxation
Constitutional Considerations
U.S. Taxation Overview
Federal Income Tax
Social Security Tax
Other Federal Taxes
State Income Tax
City and County Tax

Chapter 12. Contracts (Jacqueline E. Artinger)
Requirements of a Contract
Anatomy of a Sample Contract
Summary

Chapter 13. Crimes and Torts (Norman A. Campbell)
Crimes
Torts
Negligence
Issues for Consideration
Some Defenses

Chapter 14. Agency (Norman A. Campbell)
Parties to an Agency Relationship
Appointment Process
Duties of the Parties
Agency Termination

Chapter 15. The Interface Between Law and Ethics in Pharmacy Practice (Margaret L. Eaton)
Introduction
The Limitations of Law As an Ethical Guide
Sources of Ethics Codes and Guidelines
Basics of Ethical Reasoning
Conclusion

Chapter 16. HIPAA Privacy in the Pharmacy (Brian A. Gallagher)
What Is HIPAA?
What Information Does HIPAA Protect?
Other Privacy Laws
Notice of Privacy Practices
Treatment versus Marketing
Minimum Necessary
Additional Patient Rights
Responsibilities of Covered Entities
Educating the Public About HIPAA
Recognized Entities Under HIPAA
State Privacy Laws versus HIPAA
When PHI May Be Disclosed
Limited Exceptions to the HIPAA Privacy Rule
Complying with HIPAA in Pharmacy Transactions
Consequences of Noncompliance

Chapter 17. Medicare and Medicaid (Susan C. Winckler)
Medicare
Medicaid
Impact of Medicare and Medicaid Payor Policy
Conclusion

Chapter 18. Certification in Pharmacy: Advanced-Level Credentials, Including Specialty Certification (Richard J. Bertin)
Introduction
Council on Credentialing in Pharmacy
Six Essential Definitions
Importance of Credentials in Pharmacy
Overview of Credentialing in Pharmacy
Advanced Practice Credentials for Pharmacists
Pharmacy Supportive Personnel (Technicians)
Certification—The Future
Appendix A: Glossary
Appendix B: Referenced Pharmacy Organizations and Certification Bodies
Appendix C: Specialties Recognized by the Board of Pharmaceutical Specialties
Appendix D: Council on Credentialing in Pharmacy—Guiding Principles for Pharmacy Credentialing Activities

Chapter 19. Collaborative Drug Therapy Management (Marla J. Campbell)
History of Pharmacist Prescribing and Collaborative Drug Therapy Management in the United States
Definitions of CDTM by Different Pharmacy Organizations
Requirements for Collaborative Drug Therapy Management

Chapter 20. Supportive Personnel in Pharmacy Practice (Thomas George)
Historical Perspective
Scope of Practice
Regulation
Training
Liability Issues
Exclusionary Activities
Malpractice and Other Liabilities
Malpractice Actions
Conclusion

Chapter 21. Quality Improvement Initiatives for Pharmaceutical Care (Garry Carneal)
Introduction
Measuring Quality Improvement Is an Ongoing Challenge
The Accreditation Movement
The Role of Regulatory Oversight
Pharmaceutical-Based Accreditation/Certification Programs
Conclusions

Chapter 22. Electronic Prescribing (F. Nicholas Willard)
Introduction
Electronic Prescribing: Benefits and Operational Characteristics
Electronic Commerce Law
Impact on Pharmacy Law: Electronic Prescription Orders and Electronic Signatures
State Law Requirements of Prescription Orders
Electronic Prescription Orders for Controlled Substances
Conclusion

Chapter 23. Telepharmacy: Identifying Legal Issues for Pharmacists (Edward D. Rickert and Melissa A. Madigan)
Introduction
Licensure
Conflicts of Law
Electronic Transmission of Prescription Information
The Validity of the Prescription Order and the Physician-Patient Relationship
Health Information Privacy and Security
Other Legal Issues
Conclusion

Chapter 24. Medication Error Reporting (Jennifer Devine)
Introduction
Medication Error Reporting Programs
Legal Liability for Medication Error Reporting
The Institute of Medicine
Patient Safety Legislation
Conclusion

Chapter 25. VIPPS™: Creating a New Regulatory Model for the Internet Age (Carmen A. Catizone and Moira Gibbons)
Historical Background
The VIPPS™ Program
VIPPS™ Certification Process
New Regulatory Strategy
Conclusion
Appendix A: Abbreviated List of Rogue Online Pharmacies with Notes
Appendix B: VIPPS™ Criteria
Index
Reference Notes Included

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