Pharmacy Law Desk Reference
By:Â Albert I Wertheimer, Delbert Konnor
Paperback | 29 November 2006 | Edition Number 1
At a Glance
576 Pages
21.0 x 14.8 x 3.81
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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.
About the Editor | p. xiii |
Contributors | p. xv |
Foreword | p. xvii |
Preface | p. xix |
The Function, Evolution, and Historical Development of the Law | p. 1 |
Government Organization and Function | p. 1 |
Agency Organization and Function | p. 1 |
The Court System | p. 3 |
Order of Precedence of Authority | p. 6 |
Enactment of Legislation | p. 7 |
Code of Federal Regulations | p. 9 |
Secondary Sources of the Law | p. 14 |
Electronic Resources | p. 14 |
Forms of Business Organization | p. 17 |
Introduction | p. 17 |
Forms of Organization | p. 18 |
Piercing the Corporate Veil | p. 24 |
Conclusion | p. 24 |
Federal Food, Drug, and Cosmetic Act | p. 25 |
Introduction | p. 25 |
History | p. 27 |
Food and Drug Administration | p. 29 |
Surveillance, Enforcement, and Resolution | p. 34 |
Department of Justice, Civil Division | p. 35 |
Provisions of FFDCA Directly Applicable to Pharmacists and Pharmacies | p. 35 |
Summary | p. 38 |
The Pharmacist's Responsibility Under the Controlled Substances Act and Related Matters | p. 41 |
Background | p. 42 |
Schedules of Controlled Substances | p. 43 |
Registration Requirements | p. 45 |
Disposal of Controlled Substances | p. 49 |
Security Requirements | p. 54 |
Record-Keeping Requirements | p. 58 |
Change of Business Address | p. 60 |
Affidavit for Renewal of Retail Chain Pharmacy Registration | p. 60 |
Prescription Order Requirements | p. 61 |
Prescription Monitoring Programs | p. 67 |
Prescription Records | p. 68 |
Inventory Requirements | p. 68 |
Ordering Controlled Substances | p. 70 |
Dispensing Requirements | p. 74 |
Long Term Care Facilities | p. 81 |
Controlled Substance Distribution by a Pharmacy | p. 82 |
Narcotics for Patients with Terminal Illnesses of Intractable Pain | p. 83 |
Narcotic Treatment Programs | p. 84 |
U.S. Postal Service Mailing Requirements for Controlled Substances | p. 85 |
Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations | p. 85 |
Chemical Requiremtents: Comprehensive Methamphetamine Control Act of 1996 | p. 86 |
Pharmacists' Guide to Forged, Altered, and Stolen Prescription Blanks | p. 90 |
DEA Field Offices with Diversion Program Managers | p. 93 |
Principles of Professional Liability Insurance for Pharmacists | p. 101 |
Overview | p. 101 |
Underwriting | p. 105 |
Professional Pharmacy Liability Coverage | p. 108 |
Reading a Professional Liability and Commercial Policy | p. 109 |
Conclusion | p. 120 |
Patent Law, Trademarks, and Copyrights | p. 125 |
Trade Dress | p. 125 |
Patents | p. 126 |
Trademarks | p. 139 |
Nonpatent Protection | p. 142 |
Copyright | p. 143 |
Pharmacy Trade Regulation | p. 151 |
Antitrust Laws | p. 151 |
Antitrust Law Enforcement Mechanisms and Penalties | p. 158 |
Antitrust Enforcement in the Pharmaceutical Industry | p. 161 |
Minimizing Antitrust Risk | p. 166 |
Consumer Protection Laws | p. 168 |
Administrative Law | p. 173 |
Introduction | p. 173 |
The Need for Administrative Tribunals | p. 173 |
Separation of Powers | p. 174 |
Delegation of Legislative Power | p. 175 |
Due Process Hearing Requirement | p. 175 |
The Right To and Adequacy of Notice | p. 177 |
The Process of Administrative Adjudication | p. 180 |
Professional Practice Acts | p. 205 |
Establishing the Practice Parameters | p. 205 |
General Provisions of a Pharmacy Practice Act | p. 206 |
The Board of Pharmacy | p. 207 |
Additional Provisions of the Act | p. 208 |
Pharmacist Licensing Requirements | p. 209 |
License Renewal | p. 211 |
Pharmacy Technicians | p. 212 |
Licensing Entities | p. 213 |
Board Sanctions Against Licenses | p. 216 |
Labor and Employment Law | p. 219 |
Introduction | p. 219 |
Employment Contracts | p. 219 |
Duties Owed to the Employer | p. 221 |
Civil Rights Laws | p. 223 |
The Hiring Process | p. 228 |
Wage and Hour Laws | p. 230 |
Employee Rights | p. 233 |
Termination of Employment | p. 236 |
Taxation | p. 241 |
Introduction | p. 241 |
General Theories of and Types of Taxation | p. 241 |
Constitutional Considerations | p. 242 |
U.S. Taxation Overview | p. 243 |
Federal Income Tax | p. 243 |
Social Security Tax | p. 248 |
Other Federal Taxes | p. 248 |
State Income Tax | p. 249 |
City and County Tax | p. 249 |
Contracts | p. 251 |
Requirements of a Contract | p. 252 |
Anatomy of a Sample Contract | p. 253 |
Summary | p. 270 |
Crimes and Torts | p. 271 |
Crimes | p. 271 |
Torts | p. 272 |
Negligence | p. 274 |
Issues for Consideration | p. 275 |
Some Defenses | p. 277 |
Agency | p. 281 |
Parties to an Agency Relationship | p. 281 |
Appointment Process | p. 283 |
Duties of the Parties | p. 284 |
Agency Termination | p. 285 |
The Interface Between Law and Ethics in Pharmacy Practice | p. 289 |
Introduction | p. 289 |
The Limitations of Law As an Ethical Guide | p. 289 |
Sources of Ethics Codes and Guidelines | p. 295 |
Basics of Ethical Reasoning | p. 299 |
Conclusion | p. 306 |
HIPAA Privacy in the Pharmacy | p. 309 |
What Is HIPAA? | p. 309 |
What Information Does HIPAA protect? | p. 312 |
Other Privacy Laws | p. 312 |
Notice of Privacy Practices | p. 313 |
Treatment versus Marketing | p. 316 |
Minimum Necessary | p. 318 |
Additional Patient Rights | p. 319 |
Responsibilities of Covered Entities | p. 323 |
Educating the Public About HIPAA | p. 324 |
Recognized Entities Under HIPAA | p. 325 |
State Privacy Laws versus HIPAA | p. 326 |
When PHI May Be Disclosed | p. 327 |
Limited Exceptions to the HIPAA Privacy Rule | p. 331 |
Complying with HIPAA in Pharmacy Transactions | p. 335 |
Consequences of Noncompliance | p. 336 |
Medicare and Medicaid | p. 339 |
Medicare | p. 339 |
Medicaid | p. 344 |
Impact of Medicare and Medicaid Payor Policy | p. 348 |
Conclusion | p. 349 |
Certification in Pharmacy: Advanced-Level Credentials, Including Specialty Certification | p. 353 |
Introduction | p. 353 |
Council on Credentialing in Pharmacy | p. 354 |
Six Essential Definitions | p. 355 |
Importance of Credentials in Pharmacy | p. 356 |
Overview of Credentialing in Pharmacy | p. 357 |
Advanced Practice Credentials for Pharmacists | p. 357 |
Pharmacy Supportive Personnel (Technicians) | p. 365 |
Certification-The Future | p. 367 |
Glossary | p. 367 |
Referenced Pharmacy Organizations and Certification Bodies | p. 370 |
Specialties Recognized by the Board of Pharmaceutical Specialties | p. 373 |
Council on Credentialing in Pharmacy-Guiding Principles for Pharmacy Credentialing Activities | p. 376 |
Collaborative Drug Therapy Management | p. 381 |
History of Pharmacist Prescribing and Collaborative Drug Therapy Management in the United States | p. 381 |
Definitions of CDTM by Different Pharmacy Organizations | p. 385 |
Requirements for Collaborative Drug Therapy Management | p. 389 |
Supportive Personnel in Pharmacy Practice | p. 403 |
Historical Perspective | p. 403 |
Scope of Practice | p. 405 |
Regulation | p. 411 |
Training | p. 413 |
Liability Issues | p. 415 |
Exclusionary Activities | p. 415 |
Malpractice and Other Liabilities | p. 416 |
Malpractice Actions | p. 417 |
Conclusion | p. 420 |
Quality Improvement Initiatives for Pharmaceutical Care | p. 423 |
Introduction | p. 423 |
Measuring Quality Improvement Is an Ongoing Challenge | p. 423 |
The Accreditation Movement | p. 425 |
The Role of Regulatory Oversight | p. 432 |
Pharmaceutical-Based Accreditation/Certification Programs | p. 435 |
Conclusions | p. 441 |
Electronic Prescribing | p. 445 |
Introduction | p. 445 |
Electronic Prescribing: Benefits and Operational Characteristics | p. 446 |
Electronic Commerce Law | p. 450 |
Impact on Pharmacy Law: Electronic Prescription Orders and Electronic Signatures | p. 453 |
State Law Requirements of Prescription Orders | p. 455 |
Electronic Prescription Orders for Controlled Substances | p. 462 |
Conclusion | p. 464 |
Telepharmacy: Identifying Legal Issues for Pharmacists | p. 467 |
Introduction | p. 467 |
Licensure | p. 469 |
Conflicts of Law | p. 475 |
Electronic Transmission of Prescription Information | p. 479 |
The Validity of the Prescription Order and the Physician-Patient Relationship | p. 482 |
Health Information Privacy and Security | p. 484 |
Other Legal Issues | p. 485 |
Conclusion | p. 488 |
Medication Error Reporting | p. 491 |
Introduction | p. 491 |
Medication Error Reporting Programs | p. 492 |
Legal Liability for Medication Error Reporting | p. 494 |
The Institute of Medicine | p. 498 |
Patient Safety Legislation | p. 500 |
Conclusion | p. 503 |
VIPPS: Creating a New Regulatory Model for the Internet Age | p. 507 |
Historical Background | p. 507 |
The VIPPS Program | p. 510 |
VIPPS Certification Process | p. 511 |
New Regulatory Strategy | p. 513 |
Conclusion | p. 514 |
Abbreviated List of Rogue Online Pharmacies with Notes | p. 515 |
VIPPS Criteria | p. 516 |
Index | p. 521 |
Table of Contents provided by Ingram. All Rights Reserved. |
ISBN: 9780789018229
ISBN-10: 0789018225
Published: 29th November 2006
Format: Paperback
Language: English
Number of Pages: 576
Audience: Professional and Scholarly
Publisher: Taylor & Francis Inc
Country of Publication: US
Edition Number: 1
Dimensions (cm): 21.0 x 14.8 x 3.81
Weight (kg): 1.07
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- Non-FictionMedicineMedicine in GeneralMedicolegal Issues
- Non-FictionLawLaws of Specific JurisdictionsSocial LawMedical & Healthcare Law
- Non-FictionLawJurisprudence & General Issues
- Non-FictionMedicineNursing & Ancillary ServicesPharmacy & Dispensing
- Non-FictionLawLaws of Specific JurisdictionsConstitutional & Administrative Law