Pharmacy Practice and the Law by Richard Abood (Kainat Fatima)

Pharmacy Practice and the Law by Richard Abood (Kainat Fatima)

In this edition, we have continued the effort of previous editions: to provide a resource that is useful for teaching the facts of pharmacy law, providing a degree of depth to support those facts, and stimulating critical thinking about issues in the field. The Ninth Edition retains the format of the Eighth Edition while incorporating several of the relevant changes that have recently occurred in pharmacy law. Please refer to “New to the Ninth Edition” for a more detailed description of the changes between the previous edition and this updated Ninth Edition.

Some of the changes and updates are the result of suggestions from faculty who use this book as an assigned text in their pharmacy law courses. We appreciate the valuable feedback from those using this book and we hope that we continue to receive this feedback. Our thanks to Professor Rajul Patel, PharmD, PhD, for reviewing and editing the Medicare Part D section in Chapter 6. Although we acknowledge with gratitude the input from many trusted colleagues, we accept full responsibility for any omissions or deficiencies anyone might find in this Ninth Edition.

This text generally appeals to faculty who believe that a pharmacy law course should be much more than preparation for the board examination. The book reflects our position that a pharmacy law course should not be just about memorizing laws and regulations and learning the “rules of the game.” Rather, the course should prepare students to understand and critically analyze the law that governs both the profession and the products they distribute. Understanding requires that students know some history behind the laws, why they exist, how they affect pharmacy practice, and subsequently how to apply the law and how to analyze whether there is a better approach. Understanding pharmacy law is critical to understanding the profession. Pharmacy law reflects the history, social policy, and standards of practice that have created and shaped the profession into its current form. Our hope is that this book helps students to understand pharmacy law and, in the process, to develop an awareness and appreciation of the profession they otherwise might not have.

This book contains a great deal of information. Faculty should use their judgment as to how much they expect students to learn. Some might even wish to supplement this text with current articles or additional cases on the various legal topics. The text contains several cites to the Federal Register, Code of Federal Regulations, statutes, public laws, and websites for those wishing to delve deeper into the many topics presented.

Case Studies

Cases are included at the end of each chapter because they lead to challenging discussions, stimulate critical thinking, help students learn legal rules better and in greater depth, and kindle student interest. Each case starts with an overview designed to provide a brief explanation of the case and to generally cue the students as to what issues to think about as they read the case. As much as possible, the court’s own language has been retained. By doing so, students learn that law is seldom “black and white,” but rather requires a considerable measure of reasoning and analysis to reach a decision. Faculty should recognize that the questions raised in the overview are designed to stimulate discussion. A specific correct answer might not always exist; rather, there could be several answers to some of the questions. The notes following each case serve to address the questions arising from the case and to clarify certain points about the case.

The structure of all eight chapters remains essentially the same as that of the previous edition except, of course, for the updates. The take-away points, study scenarios, and study questions after most major chapter sections have been enhanced in this edition. The instructor can use these study scenarios and questions to lead class discussions.


Chapter 1 provides an overview of law and the legal system.

Chapters 2 and 3 cover the federal regulation of medications, with Chapter 2 describing the basic regulatory framework of food and drug law and Chapter 3 applying that framework to pharmacy practice.

Chapters 4 and 5 discuss relevant provisions of the federal Controlled Substances Act (CSA). Chapter 4 provides an overview of the framework of the CSA, while Chapter 5 applies that framework more specifically to pharmacy practice.

The main focus of Chapter 6 is the significant influence of the federal government on the state-regulated practice of pharmacy and on business and financial issues related to the profession. From the standards established in the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) to the Medicare and Medicaid laws and the federal antitrust laws, federal requirements for drugs have a profound effect on the professionals who dispense and monitor drugs. This chapter also discusses some very important recent developments involving privacy, electronic records, and pharmacy reimbursement.

Chapter 7 describes some of the basic principles of state regulation of pharmacy practice, including licensure and standards setting. Chapter 7 is intended to provide only a general overview of state law issues and contains a discussion of some important recent regulatory trends occurring among the states and discussions of the similarities and differences among state pharmacy practice acts.

Finally, Chapter 8 provides an overview of malpractice and product liability for order processing and pharmaceutical care activities, with specific tips on liability avoidance through risk management programs. Chapter 8 is important not just to understand legal risk, but also to understand the conflicting judicial opinions of the societal expectations of pharmacists, why those expectations exist, and whether they are changing. Courts mirror societal values and sometimes provide us with both flattering and unflattering perspectives of our profession.


Because the overall structure of the text remains the same, faculty who have used this text in the past should not have to make major adjustments in the way they use this new edition.

New to the Ninth Edition

There have been several legal/regulatory developments that have occurred since the publication of the Eighth Edition. This Ninth Edition includes those developments most relevant to the pharmacy profession. A brief chapter by chapter description of substantive changes includes:

Chapter 1

Chapter 1 remains essentially unchanged

Chapter 2

Changes in Chapter 2 from the previous edition include new or updated discussions of:

The Historical Overview section, including the Medical Device User Fee and Modernization Act of 2002; FDA’s 2017 Orphan Drug Modernization Plan and link to the orphan drug database; the 21st Century Cures Act of 2016; and the FDA Reauthorization Act of 2017

The Food and Drug Administration, including its organizational structure Tobacco Act, including the FDA final regulation from 2016

Drug versus cosmetic

FDA draft guidance regarding homeopathic drug products

Corporate Officer Liability under the FDCA

Product recalls, including postings of “not classified yet” recalls

Black box warnings

National Drug Code Number

Informed consent under an NDA

Prescription Drug User Fee Act’s effect on NDA review time

21st Century Cures Act and New Drug Approval

FDA’s REMS program

Drug Manufacturer Controversial Practices under the PTRA

Generic drug labeling controversies created by the courts

Drug Competition Action Plan

FDA’s Expanded Access Program

Right to Try Laws

Biologics

FDA regulation of medical devices, including the Expedited Access Pathway

FDA’s Bad Ad Program

Prescription Drug Advertising: Manufacturer to Consumer

Promoting Prescription Drugs and Devices for Off-Label Uses

Chapter 3

Changes in Chapter 3 from the previous edition include new or updated discussions of:

Labeling requirements under the FDCA

Expiration or beyond-use dating, including USP and FDA guidelines Switch of Prescription Drugs to Over-the-Counter Drugs

Emergency contraception (Plan B and other morning after pills) Conscientious Objection

Medication Guides

Approved Drugs for Off-Label (Unlabeled) Indications

The pharmacy compounding provisions under Section 503A

The Drug Quality and Security Act of 2013, including FDA compliance and draft compliance guides and updates specific to 503A and 503B pharmacies

The effect of NECC and DQSA on state compounding laws Repackaging prescription drug products

Compounding drug products that are essentially copies

Mixing, diluting, or repackaging biologicals

Hospital and health system compounding

Insanitary conditions at compounding facilities

Compounding using bulk drug substances

Radiopharmaceuticals

Memorandum of Understanding (MOU) for compounders

Prescription requirements for §503A pharmacies

Safe handling of hazardous drugs, including USP 800 Substitution of biosimilar biologics

Drug supply chain security

Pedigrees

Importation of prescription drugs for personal use

Chapter 4

Changes in Chapter 4 include new or updated discussions of the following items:

The CSA subchapters and the renaming of DEA’s Diversion Control Division

Medical and recreational use of marijuana

Distribution under the CSA

Recent DEA enforcement actions and settlements with distributors and manufacturers

Concerns over DEA enforcement actions and limiting patient access to controlled substances

Distributing versus dispensing (constructive delivery)

Applications for DEA registration and reregistration

Penalties under the CSA

Inspections under the CSA, including an increase by the DEA regarding compliance inspections of applicants and preregistration and cyclic inspections of pharmacies

Opioid Treatment Programs

Expansion of the treatment of addicts outside of OTPs (DATA)

Chapter 5

Changes in Chapter 5 include new or updated discussions of the following items:

Correcting a written controlled substance prescription

Recent DEA enforcement actions against pharmacies

Recent DEA clarification of the “knowingly” standard and what constitutes “red flags” under the CSA and corresponding responsibility doctrine Federal and state efforts to balance pain treatment with the Opioid Epidemic

State accountability for controlled substance prescriptions

Partial filling of schedule II prescriptions under CARA

Electronic transmission or controlled substance prescriptions, including DEA clarification of transferring unfilled electronic CII prescriptions to a different pharmacy

Return of controlled substances to pharmacy for disposal

Internet pharmacy prescriptions

State electronic Prescription Drug Monitoring Programs (PDMPs)

Long-term care (LTC) pharmacy

Recent DEA settlements regarding recordkeeping violations

Disposal or destruction of controlled substances

Recent DEA enforcement action for failing to report thefts or significant losses to the DEA

Chapter 6

Changes in Chapter 6 include new or updated discussions of the following items:

Liability concerns over noncompliance with OBRA ’90

Update on the status of the accounting for disclosure rules under HIPAA Recent example of improper disposal of PHI under HIPAA

Aligning HIPAA with FTC and FCC regulations

Medicare Part D beneficiary costs and enrollment updates

Medicare Part D covered drugs and plan formularies

Medicare Part D pharmacy access

MTM updates

Medicare and provider status for pharmacists

Medicaid updates

Elimination of EAC and relationship to AWP

Medicaid reimbursement for other drugs

Medicare/Medicaid fraud and abuse laws

The False Claims Act (FCA)

The Anti-Kickback Statute (AKS)

Long-term care facility updates under CMS Mega-Rule

340B drugs

Chapter 7

Changes in Chapter 7 include new or updated discussions of the following items:

The ACPE Monitor Service

Licensing of pharmacies

The new pharmacy domain (pharmacy) and VIPPS accreditation Actions against a license for incompetence or negligence Collaborative practice agreements

Regulation of managed care plan formularies and drug pricing.

Chapter 8

Changes in Chapter 8 include new or updated discussions of the following items:

Expanded responsibilities related to prior authorizations when special circumstances are found

Whether FDA-approved labeling preempts state product liability actions



  


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1 comment:

  1. Please Upload 8th edition of Lipponcot Pharmacology in original format

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