The Legal Handbook for Pharmacy Technicians

by Diane L. Darvey

Overview

The pharmacy profession is extensively regulated at both the Federal and State level. Legal requirements and regulations underpin all of the functional areas in which pharmacy technicians perform their duties.

In a simple, straightforward style, the Legal Handbook for Pharmacy Technicians teaches pharmacy technicians the essentials on how pharmacy is regulated.  Issues such as the role of laws and regulations; regulation of prescription and non-prescription drugs; FDA drug labeling, package inserts, and warnings; state registration and licensing of technicians; and confidentiality and privacy issues are covered in a concise, understandable way.

Inside you’ll find detailed information on:

• Legal and regulatory systems for pharmacy in the U.S.
• Federal and state laws and regulations for drugs
• Controlled substance laws and regulations
• Confidentiality and privacy of patient records and information

This guide also includes chapter learning objectives, key points, and chapter review questions and answers to prepare pharmacy technicians for the PTCB exam as well as their daily professional activities.

Product Details

ISBN-13:	9781585282807
Publisher:	ASHP
Publication date:	03/07/2008
Sold by:	Barnes & Noble
Format:	eBook
Pages:	160
File size:	826 KB

About the Author

Diane Darvey is Director of Public Policy  in the Government Affairs and Public Policy Division of the National Association of Chain Drug Stores in Alexandria, Virginia

Table of Contents

Dedication     iii
Preface     v
Disclaimer     vi
U.S. Legal and Regulatory System     1
Learning Objectives
Introduction
Role of Laws and Regulations
Role of Pharmacy Professional Practice Standards and Ethical Principles
Violations of Pharmacy Laws and Regulations
Summary
Self-Assessment Questions
Code of Ethics: Pharmacy Associations
Code of Ethics for Pharmacy Technicians: American Association of Pharmacy Technicians (AAPT)
Development of Laws and Rules or Regulations     15
Learning Objectives
Introduction
Federal Laws and Rules or Regulations
State Laws and Rules or Regulations
Role of State Boards of Pharmacy
Summary
References
Self-Assessment Questions
Federal Laws and Regulations for Drugs     27
Learning Objectives
Introduction
Food, Drug, and Cosmetic Act: Purpose, History, and Enforcement
Poison Prevention Packaging Act
Omnibus Budget Reconciliation Act of 1990
Medicare Modernization Act of 2003
Summary
References
Self-Assessment Questions
Food and Drug Administration     39
Learning Objectives
Introduction
The Organization
Federal Approval of Drugs
Brand Name Drugs and Generic Drugs
Generic Drug Substitution
Prescription Drug Labeling and Package Inserts
Over-the-Counter Drug Labeling
Expiration Dates, Beyond-Use Dates, and Lot Numbers
Summary
References
Self-Assessment Questions
Controlled Substances Laws     53
LearningObjectives
Introduction
Controlled Substances Laws
Drug Enforcement Administration
State Prescription Monitoring Programs
Restrictions on Sales of Products Containing Ephedrine, Pseudoephedrine, and Phenylpropanolamine
Summary
References
Self-Assessment Questions
State Laws and Regulations for Pharmacy Practice     69
Learning Objectives
Practice of Pharmacy
Pharmacies and Pharmacists
Pharmacy Technicians
Quality Improvement Programs
Patient Counseling
Summary
References
Self-Assessment Questions
NABP Model Act Article IV-Discipline
State Boards of Pharmacy
Privacy of Patient Health Information     127
Learning Objectives
Introduction
Federal Protections for Patient Health Information
State Laws Protecting Patient Health Information
Summary
Self-Assessment Questions
Self-Assessment Answers     137
Index     141

Editorial Reviews

Reviewer: Adrienne L Au, Pharm.D(Temple University School of Pharmacy)
Description: This is the first handbook of pharmacy laws and regulations geared towards pharmacy technicians.
Purpose: Pharmacy technicians play an important role in the daily operations of any pharmacy and it is important for them to be knowledgeable about pharmacy laws and regulations. The author uses a simple, easy-to-follow format to outline these guidelines. The key points and self-assessment tools enhance the book's objectives.
Audience: The book is targeted at pharmacy technicians working in both inpatient and outpatient settings. With both a PharmD and a JD, the author is a credible authority.
Features: The strength of this book lies in its discussion of pharmacy ethics, rules, and regulations. It also outlines what pharmacy technicians can and cannot do, such as patient counseling or using their professional judgment. Features such as key points and self-assessment tools reinforce its main concepts. The book covers the topic of pharmacy laws in great detail, although it may be too in-depth for its target audience.
Assessment: While there are several books on the market covering the topic of pharmacy laws and regulations, this appears to be the first specifically targeting pharmacy technicians.

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