Pharmacy Law Desk Reference

by Wertheimer; Albert I

• ISBN13: 9780789018229
• ISBN10: 0789018225
• Edition: 1st
• Format: Nonspecific Binding
• Copyright: 2006-11-29
• Publisher: Routledge

Summary

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.

Table of Contents

About the Editor	xiii
Contributors	xv
Foreword	xvii
Joseph G. Valentino
Preface	xix
Delbert D. Konnor
The Function, Evolution, and Historical Development of the Law	1	(16)
Martha M. Rumore
Government Organization and Function	1	(1)
Agency Organization and Function	1	(2)
The Court System	3	(3)
Order of Precedence of Authority	6	(1)
Enactment of Legislation	7	(2)
Code of Federal Regulations	9	(5)
Secondary Sources of the Law	14	(1)
Appendix: Electronic Resources	14	(3)
Forms of Business Organization	17	(8)
Francis B. Palumbo
George E. Rippel Jr.
Introduction	17	(1)
Forms of Organization	18	(6)
Piercing the Corporate Veil	24	(1)
Conclusion	24	(1)
Federal Food, Drug, and Cosmetic Act	25	(16)
Larry R. Pilot
Introduction	25	(2)
History	27	(2)
Food and Drug Administration	29	(5)
Surveillance, Enforcement, and Resolution	34	(1)
Department of Justice, Civil Division	35	(1)
Provisions of FFDCA Directly Applicable to Pharmacists and Pharmacies	35	(3)
Summary	38	(3)
The Pharmacist's Responsibility Under the Controlled Substances Act and Related Matters	41	(60)
Delbert D. Konnor
Background	42	(1)
Schedules of Controlled Substances	43	(2)
Registration Requirements	45	(4)
Disposal of Controlled Substances	49	(5)
Security Requirements	54	(4)
Record-Keeping Requirements	58	(2)
Change of Business Address	60	(1)
Affidavit for Renewal of Retail Chain Pharmacy Registration	60	(1)
Prescription Order Requirements	61	(6)
Prescription Monitoring Programs	67	(1)
Prescription Records	68	(1)
Inventory Requirements	68	(2)
Ordering Controlled Substances	70	(4)
Dispensing Requirements	74	(7)
Long Term Care Facilities	81	(1)
Controlled Substance Distribution by a Pharmacy	82	(1)
Narcotics for Patients with Terminal Illnesses of Intractable Pain	83	(1)
Narcotic Treatment Programs	84	(1)
U.S. Postal Service Mailing Requirements for Controlled Substances	85	(1)
Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations	85	(1)
Chemical Requirements: Comprehensive Methamphetamine Control Act of 1996	86	(4)
Pharmacists' Guide to Forged, Altered, and Stolen Prescription Blanks	90	(3)
Appendix: DEA Field Offices with Diversion Program Managers	93	(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)
Copyright	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