PHARMACY What It Is and HowItWorks Third Edition

WILLIAM N. KELLY

~ CRC Press V Taylor & Francis Group Boca Raton London NewYork

CRC Press is an imprint of the Taylor & Francis Group, an Informa business

Contents Foreword ............................................................................................................... xxix Preface ................................................................................................................... xxxi Acknowledgments .............................................................................................. xxxiii About the Author ................................................................................................. xxxv

Chapter 1 What Is Pharmacy? .............................................................................. 1

Introduction .......................................................................................... 1 Learning Objectives ............................................................................. 1 Pharmacy .............................................................................................. 1 What Is a Profession? ........................................................................... 2

Study and Training .......................................................................... 2 Measure of Success .................. , ...................................................... 3 Associations ..................................................................................... 3 The Business of Pharmacy .............................................................. 3

ABrief History of Pharmacy ............................................................... 3 Early Development .......................................................................... 3 Community Pharmacy in Early America ....................................... .4 Hospital Pharmacy in Early America .............................................. 6

What Is the Purpose of Pharmacy? ...................................................... 8 What Controls Pharmacy? ................................................................... 8

Pharmacy Licensure ........................................................................ 8 State Pharmacy Laws ...................................................................... 8 State Pharmacy Rules and Regulations ........................................... 9 Federal Laws ................................................................................... 9

What Shapes Pharmacy? ...................................................................... 9 Scope of Practice ............................................................................. 9 Organizations .................................................................................. 9 House of Delegates ........................................................................ 10 Standards of Practice ..................................................................... 10 Consensus Conferences ................................................................. 10 Conference Proceedings and White Papers .................................. 10 Study Commissions ....................................................................... 12 Leadership ..................................................................................... 12 Peer Review ................................................................................... 14 Pharmacy Ethics ............................................................................ 14

The Value of Pharmacy ...................................................................... 16 Summary ............................................................................................ 16 Discussion Questions and Exercises .................................................. 17 Challenges .......................................................................................... 17 Web Sites of Interest. .......................................................................... 17 References .......................................................................................... 18

vii

viii Contents

Chapter 2 The Pharmacist... ................................................................................ 21

Introduction ........................................................................................ 21 Learning Objectives ........................................................................... 21 Who Are Pharmacists? ....................................................................... 21 Education and Training ...................................................................... 22

Formal Education .......................................................................... 22 Internship ....................................................................................... 23 Licensure ....................................................................................... 23 Postgraduate Training .................... '" ............................................. 24 Fellowships .................................................................................... 25 Specialty Certification ................................................................... 26 Continuing Education .................................................................... 27 Postgraduate Education ................................................................. 28

Characteristics of Pharmacists ........................................................... 28 Skills and Traits ............................................................................. 28 Character and Virtues .................................................................... 29 Habits ............................................................................................. 30 Professionalism .............................................................................. 31

What Pharmacists Da ......................................................................... 32 Quality Controller ......................................................................... 32 Caregiver ....................................................................................... 33 Clinician ........................................................................................ 33 Problem Solver .............................................................................. 33 Advisor .......................................................................................... 34 Teacher ........................................................................................... 34 Manager, Supervisor, and Leader .................................. '" ............. 34 Owner ............................................................................................ 35 Researcher ..................................................................................... 35 Sales Representative ...................................................................... 35 Quality Reviewer ........................................................................... 36

Titles and Career Paths ....................................................................... 36 Job Titles ........................................................................................ 36 Career Paths ................................................................................... 36

Expectations of Pharmacists .............................................................. 36 Supply and Oemand for Pharmacists ................................................. 37 The Rewards of Being a Pharmacist .................................................. 38

Intrinsic Factors ............................................................................. 38 Extrinsic Factars ............................................................................ 38 Job Satisfaction .............................................................................. 40 Job Stress ....................................................................................... 40

Lifelong Learning and Career Planning ............................................ 41 Job Outlook ........................................................................................ 42 Summary ............................................................................................ 42 Discussion Questions and Exercises ................................................. .42

Contents ix

Challenges .......................................................................................... 43 Web Sites of Interest. .......................................................................... 43 References .......................................................................................... 44

Chapter 3 Pharmacists and the Health Care System ......................................... .47

Introduction ........................................................................................ 47 Learning Objectives ........................................................................... 47 Disease Burden ................................................................................... 48 Overview of the Health Care System in the United States ................ 48

Access to Care ............................................................................... 49 Quality of Care .............................................................................. 49 Cost ................................................................................................ 50 Financing ....................................................................................... 52

Private-Sector Funding ............................................................. 52 Public-Sector Funding .............................................................. 53

Paying Providers ............................................................................ 55 Affordable Health Care Act ............................................................... 55 The Delivery of Care .......................................................................... 56

Patient-Centered Care .................................................................... 56 The Health Care Team .................................................................. 57 Prescribing Authority .................................................................... 57 Patient Confidentiality ................................................................... 57

The Place of Drugs in the Health Care System .................................. 58 The Role of Pharmacists in the U.S. Health Care System ................. 59

Societal Purpose of Pharmacy ...................................................... 60 Pharmacy's Destiny ....................................................................... 60

Accountable Care Organizations and the Medical Home .................. 60 Opportunity ................................................. '" ............................... 60

Summary ............................................................................................ 61 Discussion Questions and Exercises ........... '" .................................... 61 Challenges .......................................................................................... 61 Web Sites of Interest ............................................................... '" ......... 62 References .......................................................................................... 62

Chapter 4 The Drug Use Process ........................................................................ 65

Introduction ........................................................................................ 65 Learning Objectives ........................................................................... 65 What Is the Drug Use Process? .......................................................... 65 Part I-Drug Products and Distribution ............................................ 65

The Drugs ...................................................................................... 66 Distribution of Drugs from Pharmaceutical Manufacturers ......... 68 Distribution from Drug Wholesalers ............................................. 68 Distribution from Distribution Centers and Repackagers ............. 69 Counterfeit Drugs .......................................................................... 69

x Contents

Self-Care and the Role of OTC Medication ....................................... 70 Self-Care ........................................................................................ 70 Over-the-Counter Medication ....................................................... 70 Complementary and Alternative Medications ............................... 71 Dietary Supplements ..................................................................... 72 Tips for Consumers ........................................................................ 72

Prescribing Drugs ............................................................................... 72 The Prescription ............................................................................ 73 Parts of aPrescription ................................................................... 73 Types of Prescriptions ................................................................... 75 Writing the Prescription ................................................................ 75 Drug Orders ................................................................................. ·· 75 Drug Sampies ................................................................................ 75

Dispensing .......................................................................................... 76 Types of Retail Pharmacies ........................................................... 76

Independent Community Pharmacies ....................................... 77 Chain Store Pharmacies ............................................................ 77 Mass Merchandiser Pharmacies ............................................... 77 Food Store Pharmacies ............................................................. 77 Mail-Order Pharmacies ............................................................ 77 Outpatient Pharmacies in Hospitals ......................................... 78 Internet Pharmacies .................................................................. 78

The Dispensing Process ................................................................ 78 Drug Distribution in Organized Health Care Settings ....................... 78 Drug Sales .......................................................................................... 79

Drugs Are Big Business ................................................................ 79 Why Costs for Drug Prescriptions Are Rising .............................. 80

Part II-Medication Use .................................................................... 81 Medication Use in the United States ............................................. 81

Drug Pricing ....................................................................................... 82 Manufacturers ................................................................................ 82

Multitier Pricing ....................................................................... 82 Prices for US.-Made Drugs in Other Countries ....................... 83

Buyers and SeIlers of Prescription Drugs .......................................... 83 Drug Wholesalers .......................................................................... 83 Community Pharmacy ................................................................... 83

Buying ....................................................................................... 83 SeIling ....................................................................................... 84

Third-Party Contracts .................................................................... 84 Medicaid Patients .......................................................................... 84 Medicare Patients .......................................................................... 85 Gross Margin, Reimbursement, and Making a Profit ................... 85 Hospitals ........................................................................................ 85

Buying ....................................................................................... 86 Formularies ............................................................................... 86

Contents XI

Projeeting Drug Costs ............................................................... 86 Selling ....................................................................................... 86 Reimbursement ......................................................................... 87

Managed Care ............................................................................... 87 Buying ....................................................................................... 87 Selling ....................................................................................... 88

Part III-Patients ............................................................................... 88 Eeonomie Value of Pharmaeeutieals .................................................. 88 Medieation Administration ................................................................ 88

Complianee with Taking the Medieation as Preseribed ................ 89 The Problem .............................................................................. 89 Cost ........................................................................................... 90

Solutions ........................................................................................ 90 Quality Drug Therapy ........................................................................ 91 How Drug Therapy Is Monitored and Reviewed ............................... 92 Patient Outeomes ................................................................................ 93 Medieation Safety ............................................................................... 93

Side Effeets .................................................................................... 93 Adverse Drug Reaetions ................................................................ 93 Allergie Drug Reaetions ................................................................ 94 Drug-Drug Interaetions ................................................................ 94 Medieation Errors .......................................................................... 94

Horne Medieation ............................................................................... 94 Control of the Drug Use Proeess ........................................................ 94 Current Issues in the Drug Use Proeess ............................................. 95

Nutrieeutieals and HerbaI Medieines ............................................ 95 Direet-to-Consumer Advertising of Preseription-Only Drugs ........ 95 Importing of Drugs from Other Countries .................................... 95 Rising Number of Preseriptions and Not Enough Pharmaeists ....... 96

Summary ............................................................................................ 96 Diseussion Questions and Exereises .................................................. 96 Challenges .......................................................................................... 97 Web Sites of Interest. .......................................................................... 97 Referenees .......................................................................................... 97

Chapter 5 Pharmaey Supportive Personnel ...................................................... 101

Introduetion ...................................................................................... 101 Learning Objeetives ......................................................................... 101 The Pharmaey Teehnieian ................................................................ 102 Employment ..................................................................................... 102 Why Pharmacy Teehnicians Are Important .................................... 102 What Pharmaey Teehnieians Do ...................................................... 103

Funetions of Pharmaey Supportive Personnel... .......................... 103 What Pharmaey Teehnieians Need to Know ................................... 105 How Pharmaey Supportive Personnel Are Trained ......................... 105

xii Contents

Technician Certification and Competency ....................................... 107 Certification ................................................................................. 107 Competency ................................................................................. 108

Pharmacy Technician Organizations ............................................... 108 Supervision of Pharmacy Technicians ............................................. 109 Being a Professional Pharmacy Technician ..................................... 110

Earnings ....................................................................................... 111 Working Conditions ..................................................................... 111 Satisfaction .................................................................................. 111 Advancement and Expanded Roles ............................................. 111

Job Outlook ...................................................................................... 112 White Paper on Needed Changes ..................................................... 112 Summary .......................................................................................... 112 Discussion Questions and Exercises ................................................ 113 Challenges ........................................................................................ 113 Web Sites of Interest ......................................................................... 114 Additional Pharmacy Technician Texts and Resources ................... 114 Acknowledgment. ............................................................................. 114 References ........................................................................................ 114

Chapter 6 Pharmacy Informatics ...................................................................... 117

Introduction ...................................................................................... 117 Learning Objectives ......................................................................... 117 Information Technology, Automation, and Informatics ................... 117 Improved Safety ............................................................................... 118 Improved Patient Care ...................................................................... 119 Improved Efficiency ......................................................................... 119 Improved Documentation of Care .................................................... 119 Pharmacy Informatics in the Drug Use Process .............................. 119

Prescribing ................................................................................... 119 E-Prescribing ............................................................................... 120 Computerized Prescriber Order Entry ........................................ 120 Perfeetion ., ................................................................................... 120 Dispensing ................................................................................... 121 Administration ............................................................................. 122 Monitoring ................................................................................... 122 Education ..................................................................................... 122 Telepharmacy .............................................................................. 123 Summary ..................................................................................... 124

Automation ....................................................................................... 124 ABrief History ............................................................................ 124 Benefits of Pharmacy Automation ............................................... 124 Challenges of Pharmacy Automation .......................................... 125 Selecting Pharmacy Automation ................................................. 126

Contents xiii

The Market for Pharmacy Automation ............................................ 126 Types of Pharmacy Automation .................................................. 126

Tablet Counters ....................................................................... 126 Intravenous Compounders ...................................................... 126 Dispensing Machines .............................................................. 127

Safety of Automated Devices ...................................................... 128 Automating the Pharmacy ................................................................ 129 Freeing Pharmacists for Pharmaceutical Care ................................. 130 The Future ........................................................................................ 130 Summary .......................................................................................... 130 Discussion Questions and Exercises ................................................ 131 Challenges ........................................................................................ 131 Web Sites of Interest ......................................................................... 131 Blog Sites of Interest ........................................................................ 132 Twitter Addresses ............................................................................. 133

Informatic Pharmacists ............................................................... 133 Medical Informatics .................................................................... 133

References ........................................................................................ 133

Chapter 7 Pharmaceutical Care ........................................................................ 137

Introduction ...................................................................................... 137 Learning Objectives ......................................................................... 137 Theory of Practice ............................................................................ 137 ABrief History of Pharmacy Practice in the United States ............. 138

The Apothecary ........................................................................... 138 Drug Dispensing and Distribution ............................................... 138 Clinical Pharmacy ....................................................................... 139

From Clinical Pharmacy to Pharmaceutical Care ........................... 140 What Is Pharmaceutical Care? ......................................................... 141

Elements of Pharmaceutical Care ............................................... 141 Responsible Provision of Care ................................................ 141 Direct Provision of Care ......................................................... 142 Caring ..................................................................................... 143 Achieving Positive Outcomes ................................................. 143 Improving the Patient's Quality of Life .................................. 144 Resolution of Medication-Related Problems .......................... 144

Pharmaceutical Care versus Clinical Pharmacy .............................. 146 Learning about Pharmaceutical Care ............................................... 146 Providing Pharmaceutical Care ....................................................... 149

Standard Process ......................................................................... 149 Selecting Patients to Monitor ...................................................... 150 Identifying, Resolving, and Preventing Medication-Related Problems ...................................................................................... 150

Identifying Medication-Related Problems .............................. 150

xiv Contents

Resolving Medication-Related Problems ............................... 150 Preventing Medication-Related Problems .............................. 151

Patient Problem List .................................................................... 151 Pharmaceutical Care Plan ........................................................... 152 Making Cents of Pharmaceutical Care ....................................... 153

Why Perform Pharmaceutical Care? ................................................ 154 The Patient ............................................................................ ······· 154 Problems in the Drug Use Process .............................................. 155 Drug-Related Morbidity and Mortality ....................................... 155

Pharmaceutical Care Works ............................................................. 156 Patients Are Spared Medication-Related Morbidity and Mortality ...................................................................................... 156 Pharmaceutical Care Is Cost -Effective ....................................... 157 Patients Love Pharmaceutical Care ............................................. 157 Other Health Care Practitioners Love Pharmaceutical Care ...... 157 Pharmacy May Become a True and Recognized Clinical Profession .................................................................................... 157

When Will All Pharmacists Practice Pharmaceutical Care? ........... 158 Barriers and Challenges .............................................................. 158

The Enemy Within .................................................................. 158 Resource-Related Constraints ................................................ 158 Lack of Support ...................................................................... 159 Legal Barriers ......................................................................... 159 Studies Documenting the Value of Pharmaceutical Care ...... 159 Lack of Payment ..................................................................... 159

Enablers to Pharmaceutical Care ................................................ 160 Changes in Pharmacy Education ............................................ 160 Certified Pharmacy Technicians ............................................. 160 Function Analysis and Workftow Redesign ............................ 160 Collaborative Practice Agreements ........................................ 160 Pharmacy Automation and Information Technology ............. 160 Medication Errors ................................................................... 161

Health Care Reform ......................................................................... 161 Implementing Pharmaceutical Care ................................................. 161

Changes the Profession Needs to Make Happen ......................... 161 Freeing Pharmacist's Time to Provide Pharmaceutical Care ......................................................... 161 Leadership and Teamwork in Implementing Pharmaceutical Care ............................................................... 162

Pharmaceutical Care in the Community and Hospital Environments ............................................................................... 162

Documenting Pharmaceutical Care ................................................. 162 Progress in Establishing Pharmaceutical Care ................................ 163 Emerging Concepts .......................................................................... 164 Summary .......................................................................................... 164

Contents xv

Discussion Questions and Exercises ................................................ 164 Challenges ........................................................................................ 165 Web Sites of Interest. ........................................................................ 165 References ........................................................................................ 165

Chapter 8 Ambulatory (Community) Pharmacy ............................................... 169

Introduction ...................................................................................... 169 Learning Objectives ......................................................................... 169 Types of Community Pharmacies .................................................... 170

Independent Pharmacies .............................................................. 170 Chain Store Pharmacies .............................................................. 171 Supermarket Pharmacies ............................................................. 172 Mass Merchandiser Pharmacies .................................................. 172 Mail-Order Pharmacies ............................................................... 173

Pharmacy Demographics ................................................................. 173 Patient Service and Satisfaction ....................................................... 173 Pharmaceutical Care ........................................................................ 174

Extent and Growth ....................................................................... 174 Some Bright Spots ....................................................................... 175 Disappointments .......................................................................... 176 Challenges ................................................................................... 176 Catalysts ...................................................................................... 177

Dispensing Procedures to Advance Pharmaceutical Care ............... 177 Accept the Prescription and Establish the Pharmacist-Patient Relationship ................................................. 177 Review the Prescription and Patient Information ........................ 178 Data Entry and Review of the Patient's Medication Profile ........ 178 Review of Insurance Coverage .................................................... 178 Retrieve the Drug or Ingredients from Storage ........................... 179 Preparation or Compounding ...................................................... 179 Label the Prescription .................................................................. 180 Health Literacy ............................................................................ 180 Check for Proper Dispensing ....................................................... 181 Drug Use Review and Dispensing ............................................... 181 Medication Delivery and Patient Counseling .............................. 181

Whose Job Is It? ............................................................................... 183 Avoiding Errors in the Dispensing Process ...................................... 183

Dangerous Medication Errors ..................................................... 183 Reasons for Medication Errors .................................................... 184

Errors versus Mistakes ........................................................... 184 Not Enough Help .................................................................... 185

Community Pharmacy Services ....................................................... 186 Traditional Services ..................................................................... 186

xvi Contents

Prescription Services ........................................... ··················· 186 Over-the-Counter Drugs ......................................................... 186

Newer Services ............................................................................ 187 Types of New Services ........................................................... 187 Are Patients Using These New Pharmacy Services? ............. 188 Examp1es of How New Services Are Offered ........................ 188

Payment for Community Pharmacy Care ................................... 188 Mail-Order Pharmacies .................................................................... 189 Community Pharmacist Satisfaction ................................................ 190 Positions for Pharmacists in Community Pharmacy ........................ 190

Pharmacy Interns ......................................................................... 190 Community Pharmacy Residents ................................................ 191 Staff Pharmacists ......................................................................... 191 Store-Level and District Managers .............................................. 191 Corporate Management ............................................................... 191 Pharmacy Ownership .................................................................. 191

Future of Community Pharmacy Practice ........................................ 192 Implementing Change in Community Pharmacy Practice ............... 192 Summary .......................................................................................... \ 92 Discussion Questions and Exercises ................................................ 193 Challenges ........................................................................................ 193 Web Sites of Interest. ........................................................................ 194 References ........................................................................................ 194

Chapter 9 Health System Pharmacy ................................................................. 199

Introduction ...................................................................................... 199 Learning Objectives ......................................................................... 199 Health Systems ................................................................................. 199 Hospitals ........................................................................................... 200

How Hospitals Started ................................................................. 200 Modern Hospitals ........................................................................ 200 Types of Hospitals ....................................................................... 200

Hospital Ownership ................................................................ 201 Hospital Size ........................................................................... 201 Hospital Type .......................................................................... 201 Hospital Statistics ................................................................... 201

Hospital Accreditation ................................................................. 201 Interna! Organization .................................................................. 202

Medica! Staff Structure .......................................................... 202 Administrative Structure ........................................................ 202

Patients ............................................................................................. 203 Health Care Team ............................................................................. 203 Pharmacy Department. ..................................................................... 204

Mission of Pharmacy ................................................................... 204 Contro! of Drugs ..................................................................... 204

Contents xvii

Overseeing the Drug Use Process .......................................... 205 Ensuring Rational Drug Use ................................................... 208

Pharmaceutical Care ................................................................... 210 Clinical Pharmacy versus Pharmaceutical Care .............................. 212

Focusing on Patients Needing the Most Help ............................. 212 Avoiding Medication Misadventures ........................................... 213 Medication Errors ........................................................................ 213

Practice Models ................................................................................ 214 Education and Training .................................................................... 214 Pharmacy Staff ................................................................................. 215

Pharmacists .................................................................................. 215 Pharmacy Managers ............................................................... 215 Pharmacy Supervisors ............................................................ 216 Staff Pharmacists and C1inical Pharmacists .......................... 216 Pharmacy Supportive Personnel.. ........................................... 217

Accreditation .................................................................................... 217 2015 Initiative ................................................................................... 218 Checking on Progress ....................................................................... 218 Job Satisfaction ................................................................................. 218 Summary .......................................................................................... 219 Discussion Questions and Exercises ................................................ 219 Challenges ........................................................................................ 219 Web Sites of Interest. ........................................................................ 220 References ........................................................................................ 220

Chapter 10 Managed Care Pharmacy ................................................................. 223

Introduction ...................................................................................... 223 Learning Objectives ......................................................................... 223 What Is Managed Care? ................................................................... 224 Health Maintenance Organizations .................................................. 226 Preferred Provider Organizations .................................................... 228 Point-of-Service Plans ...................................................................... 228 Standards ............................................................................ '" ........... 229 Accreditation .................................................................................... 229 Impact of Managed Care .................................................................. 229

Good Things/Bad Things ............................................................ 229 Criticisms of Managed Care ........................................................ 230

Pharmacy Benefits Managers ........................................................... 231 Impact of Managed Care on Pharmacy ............................................ 232

Impact on Community Pharmacy ............................................... 232 Impact on Pharmacy in Organized Health Care Settings ........... 232 Pharmacy and Therapeutics Committee and the MCO Formulary .................................................................................... 233

Medication Therapy Management ................................................... 234

xviii Contents

Quality Assessment and Assurance ................................................. 234 Selecting a Target ........................................................................ 235 Developing Measurement Criteria ............................................... 235 Monitoring Drug Use .................................................................. 235 Comparing the Actual Drug Use versus the Ideal.. ..................... 236 Reporting Results ........................................................................ 236 Communicating Results .............................................................. 236 Adjusting Criteria and Performing the Review Again ................ 236

Education of Providers and Members .............................................. 237 Member Education ...................................................................... 237 Provider Education ...................................................................... 237 Ambulatory Clinics ..................................................................... 238

Health Outcomes .............................................................................. 238 Pharmacoeconomic Studies ........................................................ 239 Patient Satisfaction ...................................................................... 240 Quality of Life ............................................................................. 241

Delivering Pharmaceutical Service and Care .................................. 241 Information Systems .................................................................... 241 Prescription Networks ................................................................. 242 Prescription Benefit Design ......................................................... 242 Partnerships ................................................................................. 243 Continuity of Care ....................................................................... 243 Disease State Management.. ........................................................ 244 Reducing Medication Errors ....................................................... 245

Being a Pharmacist in Managed Care .............................................. 245 Ethics ................................................................................................ 245 Opportunities .................................................................................... 246 Summary .......................................................................................... 246 Discussion Questions and Exercises ................................................ 246 Challenges ........................................................................................ 247 Web Sites of Interest ......................................................................... 247 References ................................................................................. , ...... 247

Chapter 11 Horne Health and Hospice Care Pharmacy ...................................... 251

Introduction ...................................................................................... 251 Learning Objectives ......................................................................... 251 Background ...................................................................................... 251 Statistics ........................................................................................... 252 Horne Care Agencies ........................................................................ 252

Horne Infusions ........................................................................... 253 Providing Horne Care ....................................................................... 253

Patient Eligibility ......................................................................... 254 Standard Treatment ..................................................................... 254 Horne Care Patients ..................................................................... 254 Accreditation ............................................................................... 254

Contents xix

Horne Health Care Pharmacy Services ............................................ 255 Total Parenteral and Enteral Nutrition ........................................ 255 Pharmaceutical Care ................................................................... 255 Horne Medical Equipment ........................................................... 256 Opportunities ............................................................................... 256

The Pharmacist's Role in Horne Health Care .................................. 256 Pharmacist Functions .................................................................. 256 Competency in Horne Care ......................................................... 257

The Pharmacist's Role in Hospice Care ........................................... 257 Career Opportunities ........................................................................ 257 Rewards and Satisfaction ................................................................. 258

Success Stories ............................................................................ 258 Summary .......................................................................................... 258 Discussion Questions and Exercises ................................................ 259 Challenges ........................................................................................ 259 Web Sites of Interest. ........................................................................ 260 References ........................................................................................ 260

Chapter 12 Long-Term Care Pharmacy .............................................................. 263

Introduction ...................................................................................... 263 Learning Objectives ......................................................................... 263 The Aging Population ...................................................................... 263

The Elderly .................................................................................. 264 Goals of Long-Term Care ............................................................ 264 Diseases ....................................................................................... 264 Drug Therapy in the Elderly ........................................................ 264 Comorbidity ................................................................................. 265 Physiological Changes ................................................................. 265 Enhanced Effects ......................................................................... 266 Medication-Related Problems ..................................................... 266 Polypharmacy .............................................................................. 266

Long-Term Care Facilities ................................................................ 267 Nursing Hornes ............................................................................ 267 Assisted Living ............................................................................ 267 Continuing Care Retirement Community ................................... 267 Statistics ....................................................................................... 268 Quality of Care ............................................................................ 268 Financing Long-Term Care ......................................................... 269

Consultant Pharmacy Practice ......................................................... 269 Settings ........................................................................................ 269 Federal Laws ............................................................................... 269 Managed Care ............................................................................. 270 Standards of Practice ................................................................... 270 Accreditation ............................................................................... 270

Contents xx

Services ....................................................................................... 270 Provider Services .................................................................... 270 Consultant Services ................................................................ 271

Drug Safety .................................................................................. 277 Growth in Long-Term Care .............................................................. 277 Growth in Consultant Pharmacy Practice ........................................ 277 Certification ...................................................................................... 278 Rewards and Satisfaction ................................................................. 278 Future of Consultant Pharmacy Practice ......................................... 278 Summary .......................................................................................... 278 Discussion Questions and Exercises ................................................ 279 Challenges ........................................................................................ 279 Web Sites of Interest.. ....................................................................... 279 References ........................................................................................ 280

Cbapter 13 Government Pharmacy ..................................................................... 283

Introduction ...................................................................................... 283 Learning Objectives ......................................................................... 283 U.S. Public Health Service ............................................................... 283 Centers for Disease Control and Prevention .................................... 284

Food and Drug Administration ................................................... 284 Indian Health Service .................................................................. 285 National Institutes of Health ........................................................ 285 Federal Bureau of Prisons ........................................................... 286 Environmental Protection Agency (EPA) ................................... 286 Agency for Toxic Substances and Disease Registry (ATSDR) ................................................................ 286 Agency for Healthcare Research and Quality (AHRQ) .............. 287 Centers for Medicare and Medicaid Services (CMS) .................. 287 Substance Abuse and Mental Health Services Administration (SAMHSA) ......................................................... 287 Other Areas ................................................................................. 287 Commissioned Corps .................................................................. 287

Department of Defense .................................................................... 288 U.S. Army .......................................................................... , ......... 289 U.S. Navy ..................................................................................... 289 U.S. Air Force .............................................................................. 290 Opportunities with the DOD ....................................................... 290

Department of Veterans Affairs ....................................................... 290 Consolidated Mail Outpatient Pharmacy System ....................... 291 Ambulatory Pharmaceutical Care ............................................... 291

Independent Prescribing Privileges ........................................ 292 A Focus on Patient Outcomes ..................................................... 292 Pharmacist Career Ladder Program ............................................ 293 Satisfaction .................................................................................. 293

Contents XXI

Federal Hospitals .............................................................................. 293 Drug Enforcement Administration (DEA) ....................................... 293 Working for State Government ........................................................ 294 Rewards and Satisfaction ................................................................. 294 Summary .......................................................................................... 294 Discussion Questions and Exercises ................................................ 295 Challenges ........................................................................................ 295 Web Sites of Interest. ........................................................................ 296 References ........................................................................................ 296

Chapter 14 Drug Information and Poison Control... ........................................... 299

Introduction ...................................................................................... 299 Learning Objectives ......................................................................... 299 Drug Information ............................................................................. 300

Brief History ................................................................................ 300 Drug Information Centers ........................................................... 300

Functions ................................... '" ........................................... 301 Answering Drug Information Questions ................................ 301 Drug Evaluations .................................................................... 303 Education ................................................................................ 303

Key Resources ............................................................................. 304 Drug Information in the Pharmaceutical Industry ...................... 304 Marketing .................................................................................... 304 Value ............................................................................................ 304 Drug Information Pharmacists .................................................... 305 Rewards and Satisfaction ............................................................. 305 Future of Drug Information ......................................................... 305

Poison Information ........................................................................... 306 Brief History ................................................................................ 306 Poison Control Centers Today ..................................................... 306 Statistics ....................................................................................... 307 Resources ..................................................................................... 307 Cost-Effectiveness ....................................................................... 307 Answering Poison Questions ....................................................... 307 Staffing ........................................................................................ 308 Disaster Planning and Terrorism ................................................. 308 The Poison Information Pharmacist.. .......................................... 308 Rewards and Satisfaction ............................................................. 309 Future of Poison Information ...................................................... 309

Summary .......................................................................................... 309 Discussion Questions and Exercises ................................................ 309 Challenges ........................................................................................ 310 Web Sites of Interest. ........................................................................ 310 References ........................................................................................ 310

XXII Contents

Chapter 15 Pharmacy Academia ........................................................................ 313

Introduction ...................................................................................... 313 Learning Objectives ......................................................................... 313 ABrief History ................................................................................. 314 Schools and Colleges of Pharmacy .................................................. 315

Statistics ....................................................................................... 315 Accreditation ............................................................................... 315 Structure ...................................................................................... 315

Pharmacy Students ..................................................................... ······ 316 Supply of Pharmacists ...................................................................... 316 Pharmacy Faculty ............................................................................. 318

Rank ............................................................................................ 318 Tenure .......................................................................................... 318 Faculty Responsibil ities ............................................................... 319 Scholarship of Teaching .............................................................. 320 Undergraduate Teaching .............................................................. 321 External Doctor of Pharmacy Degree ......................................... 324 Graduate Education ..................................................................... 324 Delivery Strategies ...................................................................... 325 Assessment and Evaluation ......................................................... 326 The Scholarship of Research ....................................................... 327 Service ......................................................................................... 328

Faculty Evaluation ............................................................................ 328 Job Satisfaction ................................................................................. 329 Preparation for an Academic Career.. .............................................. 329 Summary .......................................................................................... 329 Discussion Questions and Exercises ................................................ 329 Challenges ........................................................................................ 330 Web Sites of Interest. ........................................................................ 330 References ........................................................................................ 331

Chapter 16 Pharmacy Organizations .................................................................. 333

Introduction ...................................................................................... 333 Learning Objectives ......................................................................... 333 ABrief History ................................................................................. 333 The Role of Pharmacy Organizations .............................................. 335 The Importance of Membership ....................................................... 335 Pharmacy Organizations .................................................................. 335

Pharmacy Practitioner Organizations ......................................... 336 American College of Apothecaries (ACA) ............................. 336 American College of Clinical Pharmacy (ACCP) .................. 336 Academy of Managed Care Pharmacy (AMCP) .................... 336 American Pharmacists Association (APhA) .......................... 337 American Society of Consultant Pharmacists (ASCP) ........... 337

Contents xxiii

American Society of Health-System Pharmacists (ASHP) .... 337 International Academy of Compounding Pharmacists (IACP) ................................................................ 337 National Community Pharmacists Association (NCPA) ........ 338 National Pharmaceutical Association (NPhA) ....................... 338 Joint Commission of Pharmacy Practitioners (JCPP) ............ 338 National Alliance of State Pharmacy Associations (NASPA) ..................................................... 339

Educational Organizations .......................................................... 339 Accreditation Council for Pharmaceutical Education (ACPE) .................................................................................... 339 American Association of Colleges of Pharmacy (AACP) ...... 339 American Foundation for Pharmaceutical Education (AFPE) ....... , ........... '" ......................................... 339

Special Interest Organizations ..................................................... 340 American Association of Homeopathic Pharmacists (AAHP) ................................................................................... 340 American Association of Pharmaceutical Scientists (AAPS) ................................................................ 340 American College of Veterinary Pharmacists (ACVP) .......... 340 American Institute of the History of Pharmacy (AIHP) ........ 340 American Society for Automation on Pharmacy (ASAP) ...... 341 American Society of Pharmacognosy (ASP) .......................... 341 American Society for Clinical Pharmacology and Therapeutics (ASCPT) ........................................................... 341 American Society for Parenteral and Enteral Nutrition (ASPEN) ................................................................................. 341 American Society for Pharmacy Law (ASPL) ........................ 342 Association of Clinical Research Professionals (ACRP) ........ 342 Christian Pharmacists Fellowship International (CPFI) ........ 342 Food and Drug Law Institute (FDLI) ..................................... 342 International Society for Pharmaceutical Engineering (ISPE) ...................................................................................... 342 International Society for Pharmacoepidemiology (ISPE) ...... 343 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) .................................................. 343 Parenteral Drug Association (PDA) ......... , ............................. 343 Pediatric Pharmacy Advocacy Group (PPAG) ....................... 343 Society of Veterinary Hospital Pharmacists (SVHP) " ........... 344

Pharmacy Technician Organizations ........................................... 344 American Association of Pharmacy Technicians (AAPT) .... 344 National Pharmacy Technician Association (NPTA) ............. 344 Pharmacy Technician Certification Board (PTCB) ................ 344 Pharmacy Technician Educators Council (PTEC) '" .............. 345

Pharmacy Trade Organizations ................................................... 345 Chain Drug Marketing Association (CDMA) ........................ 345

xxiv Contents

Food Marketing Institute (FMI) ............................................. 345 Generic Pharmaceutical Association (GPhA) ........................ 345 Healthcare Distribution Management Association (HDMA). 346 National Pharmaceutical Council (NPC) ............................... 346 National Association of Chain Drug Stores (NACDS ) .. , ....... 346 Pharmaceutical Care Management Association (PCMA) ...... 346 Pharmaceutical Research and Manufacturers of America (PhRMA) ................................................................................ 347

Other Organizations .................................................................... 347 Board of Pharmacy Specialties (BPS) .................................... 347 Commission for Certification in Geriatrie Pharmacy (CCGP) .................................................................................... 347 International Pharmaceutical Federation (PIP) ...................... 347 National Association of Boards of Pharmacy (NABP) .......... 348 United States Pharmacopeia (USP) ........................................ 348

Should Pharmacy Organizations Change? ....................................... 348 Summary .......................................................................................... 349 Discussion Questions and Exercises ................................................ 349 Challenges ........................................................................................ 350 Web Sites of Interest. ........................................................................ 350 References ........................................................................................ 350

Chapter 17 How Drugs Are Discovered, Tested, and Approved ........................ 351

Introduction ...................................................................................... 351 Learning Objectives ........................................................................ , 351 ABrief History of Drug Discovery and Development... .................. 352 How New Drugs Are Discovered ..................................................... 352 Drug Discovery ................................................................................ 353

Plant Poisons ................................................................................ 353 Inorganic Chemieals .................................................................... 353 Drugs from Animal Sources (Biologics) ..................................... 354 Drugs from the Seas .................................................................... 354 Screening for New Natural Drug Products ................................. 354 Synthetic Substitutes .................................................................... 354 Biotechnology .............................................................................. 355

New Methods of Drug Design ......................................................... 355 The Drug Researcher ....................................................................... 355

Pharmaceutical Chemistry .......................................................... 355 Clinical Pharmacology 355 Biopharmaceutics and cii~i~~i·Ph·~;~~~·~k·i~~~i~·~:::::::::::::::::::::: 356 Clinical Toxicology ........................ , ............................................ 356 Pharmaceutics 356

Drug Testing ....... :::: ::::: :::: ::::: ::::: ::: :::::::::::::::: :::::::::::::: :::::: :::::::::::::::: 356 Animal Testing ............................................................................ 356 Testing in Humans ....................................................................... 357

Contents xxv

Phase 1 Clinical Trials ............................................................ 358 Phase 2 Clinical Trials ............................................................ 358 Phase 3 Clinical Testing ......................................................... 358

Who Oversees Research on Investigational Drugs? ......................... 359 Drug Standards ................................................................................. 360 How Drugs Are Approved for Use ................................................... 360

Classification of New Drugs by the FDA .................................... 361 Chemical Type ........................................................................ 361 Potential Benefit. ..................................................................... 361

Time and Cost of Drug Development ............ , ................................. 361 Drug Manufacturing ........................................................................ 363 Generic Drugs .................................................................................. 363 Drug Efficacy Study Implementation Drugs .................................... 363 Homeopathic Drugs ......................................................................... 364 Nonprescription Drugs ..................................................................... 364 Postmarketing Surveillance of New Drugs ...................................... 364 Current Issues in Drug Development ............................................... 365

The FDA under Fire .................................................................... 366 Future of Drug Discovery ................................................................ 366 Summary .......................................................................................... 366 Discussion Questions and Exercises ................................................ 367 Challenges ........................................................................................ 367 Web Sites of Interest. ........................................................................ 368 References ........................................................................................ 368

Chapter 18 The Pharmaceutical and Biotechno1ogy Industry ............................ 371

Introduction ...................................................................................... 371 Learning Objectives ......................................................................... 371 Pharmaceutical Companies .............................................................. 371

Organizational ................................................................ '" ., ........ 372 Research and Development... .................................................. 373 Regulatory Affairs .................................................................. 373 Manufacturing, Production, and Quality Control .................. 373 Medical Affairs ....................................................................... 374 Sales and Marketing ............................................................... 374 Trade and Professional Relations ............................................ 374 Management and Administration ........................................... 374

Pharmacists in the Pharmaceutica1 Industry .................................... 374 Working in Sales ......................................................................... 375 Working in Marketing ................................................................. 376 Working in Advertising ............................................................... 376 Working in Management and Administration ............................. 376 Working in Research and Development ...................................... 377 Working in Medical Affairs ........................................................ 377

Working as a Medical Science Liaison .................................. 377

xxvi Contents

Working in Orug Information ................................................ 377 Working in Medical Writing .................................................. 378 Working in Outcomes Research ............................................. 378 Working in Orug Safety .......................................................... 378

Working in Manufacturing, Production, and Quality Control .... 379 Working in Trade and Professional Affairs ................................. 379 Working in Regulatory Affairs ................................................... 379 Moving from Practice to the Industry ......................................... 379 Female Pharmacists in the Pharmaceutical Industry .................. 380

Satisfaction and Career Advancement ............................................. 380 Case Studies ..................................................................................... 381 Criticisms of the Industry ................................................................. 381 Summary .......................................................................................... 381 Oiscussion Questions and Exercises ................................................ 382 Challenges ........................................................................................ 382 Web Sites of Interest. ........................................................................ 383 References ........................................................................................ 383

Chapter 19 Other Opportunities for Pharmacists ............................................... 385

Introduction ...................................................................................... 385 Learning Objectives ......................................................................... 385 Alternative Medicine ........................................................................ 385

HerbaI Medicines ........................................................................ 385 Folk Remedies ............................................................................. 386 Megavitamins .............................................................................. 386 Homeopathy ................................................................................. 386 Use of Alternative Medicines ...................................................... 386 Pharmacists and Alternative Medicines ...................................... 386

Association Management ................................................................. 387 Why Consider This Opportunity? ............................................... 387 What 00 Association Pharmacists Oo? ....................................... 387 Getting Started ............................................................................ 388

Consulting ........................................................................................ 388 Services and Clients .................................................................... 388

Education ................................................................................ 388 Public Speaking ...................................................................... 389 Professional Writing and Editing ............................................ 389 Consultant to the Pharmaceutical Industry ............................ 389 Patient Self-Care ..................................................................... 389 Setting Up Services and Providing Staffing ........................... 390 Home Health Services ............................................................ 390

Proposals ..................................................................................... 390 Fees .............................................................................................. 390 Contracts ...................................................................................... 390 Incorporation ............................................................................... 390

Contents xxvii

Hire a Good Accountant... ........................................................... 391 Risks ............................................................................................ 391 Rewards ....................................................................................... 391

Compounding Pharmacy .................................................................. 391 Forensic Pharmacy ........................................................................... 392 Information Technology ................................................................... 392 Medical Education and Communications ........................................ 392 Mail-Order Pharmacy ...................................................................... 393

Value of Mail-Order Pharmacies ................................................ 393 Wh at It Is Like Inside a Mail-Order Pharmacy .................. , ....... 393 Largest Mail-Order Pharmacy Provider ...................................... 393 Commercial Mail-Order Pharmacies .......................................... 394 Mail-Order Practice ..................................................................... 394

NucIear Pharmacy ............................................................................ 395 Pharmacy Benefit Management ....................................................... 396 Pharmacy Law .................................................................................. 396 Pharmacoeconomics and Outcomes Research ................................. 396 Pharmacoepidemiology .................................................................... 396 Pharmacy Management .................................................................... 397 Veterinary Pharmacy .......................................................... , ............ 397 Summary .......................................................................................... 397 Discussion Questions and Exercises ................................................ 398 Challenges ........................................................................................ 398 Web Sites of Interest ......................................................................... 399 References ........................................................................................ 399

Chapter 20 Career Development ......................................................................... 403

Introduction ...................................................................................... 403 Learning Objectives ......................................................................... 403 A Career ........................................................................................... 403 Career Planning ................................................................................ 404

Common Mistakes Students Make ............................................. .404 Avoiding Common Pitfalls .......................................................... 404

Finding Your Job as a Pharmacist.. ................................................. .405 More Education ........................................................................... 405 More Training ..................................... ··· ... ···· ............................... 405 Gaining Employment. .................................................................. 405

Planning .................................................................................. 406 Assessment. ............................................................................. 406 SeI f-Assessment ............................ ··································· .. · .... 406

Finding Opportunities on Your Own ......................................... .407 Developing Your Curriculum Vitae ........................................... .407

Putting It Together .................................................................. 407 Assessing the Opportunities ........................................................ 409

The Letter of Application .......................................... · ...................... 410

xxviii Contents

The Interview ................................................................................... 411 Changing Jobs .................................................................................. 413

Differentiation ............................................................................. 413 Changing from One Job to a Simi1ar Job? .................................. 414 Finding a New Job ....................................................................... 414

Changing Careers ............................................................................. 414 For More Information ....................................................................... 414 Summary .......................................................................................... 415 Discussion Questions and Exercises ................................................ 415 Challenges ........................................................................................ 416 Web Sites of Interest. ........................................................................ 416 References ........................................................................................ 416

Index ...................................................................................................................... 419