LAW AND ETHICS for Pharmacy Technicians This page intentionally left blank LAW AND ETHICS for Pharmacy Technicians Jahangir Moini, MD, MPH, CPhT Professor and Former Director Allied Health Sciences Pharmacy Technician Program Everest University Melbourne, Florida Australia • Brazil • Japan • Korea • Mexico • Singapore • Spain • United Kingdom • United States Law and Ethics for Pharmacy Technicians © 2010Delmar, Cengage Learning Jahangir Moini, MD, MPH, CPhT ALL RIGHTS RESERVED. No part of this work covered by the copyright herein may be reproduced, transmitted, stored, or used in any form or by Vice President, Career and Professional Editorial: David Garza any means graphic, electronic, or mechanical, including but not limited to photocopying, recording, scanning, digitizing, taping, Web distribution, Director of Learning Solutions: information networks, or information storage and retrieval systems, except Matthew Kane as permitted under Section 107 or 108 of the 1976 United States Copyright Acquisitions Editor: Tari Broderick Act, without the prior written permission of the publisher. Managing Editor: Marah Bellegarde For product information and technology assistance, contact us at Senior Product Manager: Darcy M. Scelsi Cengage Learning Customer & Sales Support, 1-800-354-9706 Editorial Assistant: Anthony Souza For permission to use material from this text or product, Vice President, Career and Professional submit all requests online at www.cengage.com/permissions Marketing: Jennifer McAvey Further permissions questions can be e-mailed to [email protected] Marketing Manager: Kristin McNary Marketing Coordinator: Erica Ropitzky Library of Congress Control Number: 2009925008 Production Director: Carolyn Miller Content Project Management: ISBN-13: 978-1-4283-1102-2 Pre-Press PMG ISBN-10: 1-4283-1102-5 Senior Art Director: Jack Pendleton Delmar Cengage Learning 5 Maxwell Drive Clifton Park, NY 12065-2919 USA Cengage Learning is a leading provider of customized learning solutions with offi ce locations around the globe, including Singapore, the United Kingdom, Australia, Mexico, Brazil, and Japan. Locate your local offi ce at: international.cengage.com/region Cengage Learning products are represented in Canada by Nelson Education, Ltd. To learn more about Delmar, visit www.cengage.com/delmar Purchase any of our products at your local college store or at our preferred online store www.ichapters.com Notice to the Reader Publisher does not warrant or guarantee any of the products described herein or perform any independent analysis in connection with any of the product information contained herein. Publisher does not assume, and expressly disclaims, any obligation to obtain and include information other than that provided to it by the manufacturer. The reader is expressly warned to consider and adopt all safety precautions that might be indicated by the activities described herein and to avoid all potential hazards. By following the instructions contained herein, the reader willingly assumes all risks in connection with such instructions. The publisher makes no representations or warranties of any kind, including but not limited to, the warranties of fi tness for particular purpose or merchantability, nor are any such representations implied with respect to the material set forth herein, and the publisher takes no responsibility with respect to such material. The publisher shall not be liable for any special, consequential, or exemplary damages resulting, in whole or part, from the readers’ use of, or reliance upon, this material. Printed in the United States of America 1 2 3 4 5 6 7 13 12 11 10 09 Dedication This book is dedicated to My wife Hengameh, and daughters Mahkameh and Morvarid. This page intentionally left blank Contents Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxiii Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxv About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xxvii Section I The Foundation of Law and Ethics . . . . . . . . . . . . . . . . . . . . . .1 Chapter 1: Introduction to Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Setting the Scene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Role of Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Sources of Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Constitutional Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Statutory or Legislative Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Administrative Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Common or Case Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Divisions of Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Criminal Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Civil Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Contract Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Th e U.S. Court System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Th e Diff erences between Federal Law and State Law . . . . . . . . . . .11 Statute of Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Negligence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 Malpractice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Contents vii Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Setting the Scene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Case Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 Related Internet Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 Chapter 2: Ethics in the Pharmacy Practice . . . . . . . . . . . . . . . . . 20 Setting the Scene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 Ethics, Morals, and Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 Th e Relationship between Ethics and the Law . . . . . . . . . . . . . . . . .22 Professional Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Code of Ethics for Pharmacists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Th e Patient-Pharmacist Relationship . . . . . . . . . . . . . . . . . . . . . . . 24 Patient Advocacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Respect for Patient Autonomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Professional Competence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Respect for Other Colleagues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Serving the Community . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Equitable Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Code of Ethics for Pharmacy Technicians . . . . . . . . . . . . . . . . . . . . .27 Maintain Health and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Honesty and Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Assist and Support the Pharmacist . . . . . . . . . . . . . . . . . . . . . . . . . 29 viii Contents Respect for Other Health-Care Professionals . . . . . . . . . . . . . . . . . 29 Professional Competence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Respect for Patient Autonomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Maintaining Confi dentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Observing Quality and Legal Standards . . . . . . . . . . . . . . . . . . . . . 30 Maintenance of Professional Standards . . . . . . . . . . . . . . . . . . . . . 31 Loyalty to the Employer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Making Ethical Decisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Identifying the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Gathering Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Analyzing the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Forming an Action Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Evaluating the Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Ethical Issues in the Pharmaceutical Industry . . . . . . . . . . . . . . . . . .33 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33 Setting the Scene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 Review Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 Case Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37 Related Internet Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38 Section II Federal Laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39 Chapter 3: Federal Regulation of Drug Products . . . . . . . . . . . . . 41 Setting the Scene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42 Contents ix