pharmacy and the us healthcare system fourth edition smith michael ira

Pharmacy and the US Health Care System Fourth Edition Free Pharmaceutical Press e-alerts Our latest product news straight to your inbox register@ www.pharmpress.com/alerts Pharmaceutical Press is the publishing division of the Royal Pharmaceutical Society Pharmacy and the US Health Care System FOURTH EDITION Editors Michael Ira Smith PhD President MIS Pharmaceutical Consultants, Scottsdale, AZ, USA Albert I Wertheimer PhD, MBA Professor of Pharmacy Department of Pharmacy Practice Temple University School of Pharmacy, Philadelphia, PA, USA Jack E Fincham PhD, RPh Professor Division of Pharmacy Practice and Administration The University of Missouri Kansas City School of Pharmacy, Kansas City, MO, USA Published by Pharmaceutical Press Lambeth High Street, London SE1 7JN, UK c Royal Pharmaceutical Society of Great Britain 2013 is a trade mark of Pharmaceutical Press Pharmaceutical Press is the publishing division of the Royal Pharmaceutical Society Typeset by River Valley Technologies, India Printed in Great Britain by TJ International, Padstow, Cornwall ISBN 978 85711 022 All rights reserved No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the prior written permission of the copyright holder The publisher makes no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made A catalogue record for this book is available from the British Library Dedication MIS: To Rita, Neil, Bethany, Mason and Aiden AIW: To Joaquima, Lia, Debbie and Andrew JEF: To Melinda, Derek and Joni, and Kelcie for making it all possible Contents Foreword Contributors Health and health care in the United States David M Scott, MPH, PhD xiii xvii Health and disease Historical evolution of health services The private health care sector The public health care system Health care: right or privilege? Conclusion References and further reading 12 17 19 19 Financing US health care Leanne Lai, PhD 21 Health care financing Funding sources of health care financing Challenges for US health care financing Conclusions References and further reading 21 21 31 33 33 Managed care pharmacy Judith A Cahill, CBES 35 What is managed care? Managed care pharmacy tools Roles pharmacists play in managed care settings References and further reading Bibliography 35 38 48 52 52 The health professions Albert I Wertheimer, Jr., PhD, MBA 53 Prescribing authority Health manpower Physicians 54 57 59 viii Contents Pharmacy personnel and practice site Pharmacy issues and trends Appendix 4.1 Appendix 4.2 Appendix 4.3 Appendix 4.4 References and further reading Bibliography 60 64 66 68 72 73 73 74 Pharmacists and US health care Yifei Liu, BSPharm, PhD 75 The workforce of pharmacists in the United States Conclusions References and further reading 76 90 91 Pharmacy organizations Joseph Thomas III, PhD 95 Role of pharmacy organizations Historical development of pharmacy organizations Specific pharmacy organizations Current issues for pharmacy organizations Individual decisions regarding organizations References and further reading Web sites for organizations discussed in this chapter National practitioner organizations Fraternal, leadership and honorary societies National trade organizations Education, regulatory, and foundation organizations 95 99 99 110 111 112 112 112 113 113 113 Emerging roles Richard J Bertin, PhD, RPh 115 Advanced practice credentialing Collaborative drug therapy management Other emerging practice models Conclusion Bibliography 116 122 124 125 126 Political realities of pharmacy Robert I Field, MPH, JD, PhD 127 Growth of pharmaceutical use and spending: prelude to intensifying political conflict 128 Contents ix Regulation, patents and politics Insurance for prescriptions Pharmaceutical industry research and marketing Medicare coverage The role of pharmacists The next political realities: genetics and personalized medicine Looking ahead References and further reading 130 135 138 141 143 144 146 147 Hospital and health care institutions Sherilyn J VanOsdol, PharmD, BCPS, and Charles E Daniels, BSPharm, PhD 153 History of hospitals in the United States Scope of the US health care system Focus on patient safety Future challenges facing hospitals Conclusion References and further reading Bibliography 153 156 173 175 176 176 178 10 Pharmacist role in long-term care Richard G Stefanacci, DO, MPH, and Thomas R Clark, RPh, MHS, CGP 179 The growing population of older adults Demand for health care services Medicare Parts A, B, C, and D in long-term care Health care reform Special considerations in the provision of health care to older adults Long-term care Nursing facilities The role of the geriatric pharmacist in other long-term care settings Conclusion References and further reading Online resources 11 The research manufacturing pharmaceutical industry Jean Paul Gagnon, BS, PhD Economic impact US pharmaceutical industry state of affairs Future outlook for the US pharmaceutical industry References and further reading 179 181 182 183 184 189 190 199 207 208 214 215 215 217 221 225 448 Index expansion 115–16 first established pharmacy college future directions 435–6 in geriatric pharmacy 189 in managed care systems 47 medical education 54–5 role of federal hospitals 169 pharmacy organizations 109–10 websites 113 preparation for clinical practice 419–20 role of managed care pharmacists 50–1 role of pharmacy organizations 96–7 eHealth Initiative (eHI) 400 elderly population see older population electronic commerce (EC) 240 electronic data interchange (EDI) 240 electronic health records (EHRs) 225, 386–7, 388–9 certification 393–4 cost savings 433–4 facilitation of adoption 394 future developments 405 interoperability 396–7 meaningful use 391–3 Pharmacist/Pharmacy Provider Electronic Health Record 399 electronic medical records (EMRs) 385, 386, 406 electronic prescribing 385–6, 388 associated legislation 390–1 elements to assure safe use (ETASUs) 306 emergency contraception, pharmacist prescription 57 emerging roles 56, 78, 115–16, 124–6, 247, 420–1, 426–9 advanced practice credentialing 116–22 advocacy 430–1 collaborative drug therapy management 122–4 demonstration of value 429–30 political aspects 143–4 reimbursement 431–2 see also consultant pharmacists employment trends, pharmacy 64–5 end-of-life care, ethical issues 371 engineering model, patient–practitioner relationship 255–6 environmental factors in disease epidemiology, ethnic variations 344 epoetin alfa, APPRISE program 306 errors see medical errors esteem needs 261 ethical decision-making 361–2, 374–5 ethical dilemmas 359 case studies 375–7 ethical interactions 362 ethical practice 249 ethical principles 369–73 ethical theories 368–9 ethical versus legal continuum 359–61, 360 ethics 380 definition 359 pharmacy code of ethics 363–4 history of 362 purpose 364–5 professional behavior 365–8 relationship to professionalism 365 virtues, values, morals and rights 373–4 ethnic minorities 272, 353–4 access to care 344–5 African-Americans and blacks 276–7 Asian-American population 274–5, 276 attainment of First Professional degree 332–4 compliance 352–3 Cultural and Linguistically Appropriate Services (CLAS), National Standards 341–4 cultural differences 341 definitions 328 differences in health care service use 346–51 drug responses 274 Eastern European population 275 employment in health care industry 325 enrollment into health professional schools 329, 330–1, 335–6 epidemiological variations 344 health care cultures 273–4 infant mortality Index Latino population 275–6, 319 life expectancy models of disease causation 272–3 as percentage of physicians 336, 338 as percentage of US population 318, 320–1, 323 trends 318 pharmacy graduation, trends 338–40 population growth 324, 325 population projections by race and age 326–7 preference for ethnic minority physicians 338 treatment outcome variations 345–6 workforce diversity, advantages 341–4 evidence-based care 156 expanded roles, pharmacists 56, 78 expenditure on health care 166 extensible markup language (XML) system 240 eye contact, cultural differences 341 failure mode and effects analysis (FMEA) 312 fatal illness, disclosure to patients 273 Federal Employees Health Benefit Plan (FEHBP), funding sources 27–8 federal government-provided care Community Health Centers 13–14 Indian Health Service 12–13 military medical care 12 federal hospitals 168–9 fee-for-service plans 29, 35 fellowships 118 female pharmacists, increasing numbers 77–8 feminist ethics 368 fidelity 370, 372 fiduciary relationship model, patient–practitioner relationship 256–8 financial management, role of consultant pharmacists 198–9 financing of health care 21 challenges 449 health care spending 31–2 international context 32–3 conclusions 33 see also funding sources Fleetwood Project 198 Flexner Report, 1910 follow-on biologics 134–5 Food and Drug Administration (FDA) 17, 130–1, 146, 298–9 Adverse Event Reporting System 300–1, 302 definition of important drug safety issues 302 Drug Safety Communications 303 and herbal remedies 131–2 and off-label promotion of drugs 140–1 requirements for premarket assessment 299–300 RiskMAPs 304 Task Force on Risk Management 303–4 Food and Drug Administrative Amendment Acts (FDAAA), 2007 301–2, 305 Food, Drug and Cosmetic Act, 1906 formularies 39–42, 135 aids to formulary decision-making 42–3 responsibilities of managed care pharmacists 49 formulary access rebates 47 formulary information, inclusion in meaningful use criteria 393 formulary management tools 43–4, 49 for-profit hospitals 167–8 Fostering Independence Through Technology (FITT) act 2011 402 fragmentation, pharmaceutical industry 222 frailty 184 fraternal organizations 103–4 websites 113 functional profiles, EHRs 398, 399 funding sources 21–2 private health insurance 28–9 fee-for-service plans 29 managed care systems 29–31 public financing 22–3 Children’s Health Insurance Program 28 450 Index Federal Employees Health Benefit Plan 27–8 Indian Health Service 27 Medicaid 26 Medicare 24–6 TRICARE 27 Veterans Administration (VA) system 26–7 see also financing of healthcare future directions 425–6, 436–7 education 435–6 population dynamics 432–3 providing, demonstrating, and paying for value 426–32 technology 433–5 gatekeepers 245 gender differences ethnic minorities 274 in health care consumption 277–8 in life expectancy generic drugs availability and distribution 238–9 branded 222–3, 223–4 competition for biotechnology drugs 134–5 Hatch–Waxman Act 133 over-the-counter products 287 use in managed care 39, 48–9 Generic Pharmaceutical Association (GPhA) 106 genetic factors in disease genomics 42, 130, 434 political issues 144–6 geodemographic segmentation 84 geriatric pharmacy certification 188 Commission for Certification in Geriatric Pharmacy 121 employment opportunities 188 role in error reduction 187–8 role in long-term care 189–90, 199–200 role in nursing homes 193 drug regimen review 193–5 quality assurance 196–7 see also consultant pharmacists; older population goal setting, role of pharmacy organizations 98 governing bodies, hospitals 158 government drug price negotiations 142–3 group purchasing organizations alliances with hospitals 236 alliances with pharmacies 236–7 interaction with pharmaceutical manufacturers 229 guidance–cooperation model, patient–practitioner relationship 257 guidelines see protocols Hatch–Waxman Act 133 health, definitions 1, 245 health behavior 265, 266–7 health belief models 266–7, 352–3 explanation of illness behavior 268 explanation of sick-role behavior 268 health care reforms 17–18, 33, 430 impact on drug use process 293–4 impact on older population 183 legislation 390–6 health care services historical evolution 8–9 1850–1900 5–6 1900–1945 6–7 1945–2010 7–8 2010 and beyond use, cultural differences 346–51 health care system, web of providers 156–7 health education see education health habits 4–5 health information exchanges (HIEs) 396–7, 405, 406, 407–8 health information technology (HIT) 385–6, 433–5 computerized physician (provider) order entry systems 387–8 drivers of implementation 388–90 electronic health records and electronic medical records 386–7 electronic prescribing 388 future developments 405 implications for pharmacists automated dispensing 401–2 telemedicine 402–3 interoperability 396–7 key events and legislation 390–6 organizations 399–401 Index personal health records 387 Pharmacy e-Health Information Technology Collaborative 404–5 questions for study 405–9 research roles 403–4 standards 397–9 Health Information Technology for Economic and Clinical Health Act (HITECH) 389–90, 391 health insurance benefit control vs cost 36 coverage 9–11 older population 185–6 see also private prescription insurance Health Insurance Portability and Accountability Act 1996 373, 389, 390 Health Level Seven (HL7) 398 health levels, improvements since 1900 health literacy problems 291 Health Maintenance Organization (HMO) Act, 1973 health maintenance organizations (HMOs) 10, 30, 36, 37, 249 health professionals 53 accreditation 58 certification and registration 58–9 employment percentages by industry sector 71 employment percentages by occupation 71–2 licenses and permits 59 numbers and distributions 57–8 numbers by specialty 68–70 pharmacists personnel and practice sites 60, 62–3 specialization 63–4 physicians, specialization 59–60, 61 prescribing authority 54–6 controlled drugs 66–8 pharmacists 56–7 Health Professions Education: A Bridge to Quality, IOM 435 health promotion 1, 451 Health Resources and Services Administration (HRSA) 17 Healthcare Distribution Management Association (HDMA) 106–7, 232 Healthcare Facilities Accreditation Program (HFAP) 172–3 Healthcare Information and Management Systems Society (HIMSS) 399–400 “Healthy People 2020” (DHHS) 1–3 objective areas hepatotoxicity 300 herbal remedies regulations 131–2 use by ethnic minorities 348 use by older population 185 high-tech care, limited benefits 18 Hill-Burton Act, 1946 7, 154 hip fractures, increasing incidence 181 Hispanic population see Latino population holistic approach 247 home health care drug distribution 242 role of consultant pharmacists 205–6 honorary societies 104–5 websites 113 hospice care, role of consultant pharmacists 206–7 hospital acquired preventable conditions 174 hospital services 161–2 hospital types 165 community hospitals 168 federal hospitals 168–9 investor-owned hospitals 167–8 not-for-profit hospitals 166–7 rural hospitals 169–70 specialty hospitals 170 hospitals accreditation 172–3 drug distribution channels 236 future challenges 174, 176–7 growth period health care staffing medical staff 162–3 nurses 163–4 pharmacists 164–5 history of 153–6 organizational structure 157–61, 160 452 Index ownership 162, 165–6, 167 patient safety issues 173–4 pharmacy services, expectations of accreditation groups 173 private sector regulatory environment 171–2 hot–cold disease explanatory model 273, 276 human relations (HR) department, hospitals 161 humanistic outcomes analysis 43, 84 hypercompliance 288 hypertension ethnic variations 344 in treatment response 346 noncompliance 289 illness attitudes towards 271–2 defining factors 269 ethnic models of disease causation 272–3 illness behavior 265–6, 267, 269 cultural differences 352 health belief model 268 immunizations Medicare coverage 182 pharmacist prescription and administration 56–7, 72, 124 implication questions 85–6, 89 important drug safety issues 302 indemnity (fee-for-service) plans 29 independent pharmacies 78 competition 88 work activities 80 Indian Health Service (IHS) 12–13 funding sources 27 individual consumer behavior, five stage model 260–4 infant mortality rate (IMR) 33 improvement since 1900 infectious disease mortality, influencing factors 5, informatics 125 information, importance for health-related decision-making 265 information gathering, individual consumer behavior model 260, 261–3 information sources, health care consumers direct-to-consumer advertising 250 Internet 250–1 informed consent 370, 372–3 initial noncompliance 288 innovations, diffusion of 415–18, 428–9 in-patient care expenditure 166 Institute for Healthcare Improvement (IHI) 176, 312 Institute of Medicine (IOM) 312 recommendations on reduction of medical errors 173 Institute for Safe Medication Practice (ISMP) 175, 312 institutional accreditation 58 institutional pharmacies 191 insulin, discovery integrated delivery systems (IDSs) 37–8 integrity 380 intellectual property 147, 221 impact of genomics 146 regulations 132–3 biotechnology drugs 134–5 Hatch–Waxman Act 133 intermediate care facilities 202 International Classification of Disease (ICD) codes 403–4, 409 Internet, impact on health care 247, 250–1 internet pharmacies 237–8 interoperability, health information technology 396–7, 405 interpreter services, CLAS Standards 342–3 interprofessional education 435 Interprofessional Education Collaborative (IPEC) group 435–6 investor-owned hospitals 167–8 Iowa Medicaid pharmaceutical case management program 82–3 iPLEDGE program, isotretinoin 306 Joint Commission of Pharmacy Practitioners (JCPP) 111 journals 97 state pharmacy organizations 105 judgmental acts 367 just culture strategy, adverse drug events 298 justice 370, 373 Index Kappa Epsilon 104 Kappa Psi 104 karma 274 knowledge, role in professionalism 380, 381 Lambda Kappa Sigma 104 Language Access Services, CLAS Standards 342–3 Latino population 272, 275–6, 319, 323 access to care 345 attainment of First Professional degree 332–4 enrollment into health professional schools 329, 330–1, 335, 336 growth 324 projections 326–7 health care culture 273 as percentage of registered nurse population 336, 337 pharmacy graduation, trends 338–40 lay-referral system 269–70, 349 cultural issues 352 Leapfrog Group 312 learning model of decision-making 262 legal dilemmas 359 legal versus ethical continuum 359–61, 360 legislation application to hospitals 171–2 Food and Drug Administration 130–1 of health-related behavior 265 herbal remedies 131–2 HIT-associated 389–96 intellectual property 132–3 biotechnology drugs 134–5 Hatch–Waxman Act 133 off-label promotion of drugs 140–1 pharmacovigilance 308–9 license to practice 59, 116–17 licensing examination 109 life care communities (CCRCs) 202 life events, interaction with symptoms 269 life expectancy 33 453 improvement since 1900 lifestyle practices 4–5, Lipitor cost 132 sales 224 local government-provided care 14–16 local pharmacy organizations 105–6 long-term care 10 adult day services 201–2 assisted living facilities (ALFs) 200–1 continuing care retirement communities 202 definition 189 intermediate care facilities 202 nursing facilities 190–1 Program for All-Inclusive Care for the Elderly (PACE) 203–5 role of consultant pharmacists 179, 189–90 settings 189 mail-order pharmacy 79 managed care pharmacists 64–5 Academy of Managed Care Pharmacy 103 corporate functions 51–2 operational functions contract negotiations 50 drug utilization review (DUR) 50 formularies 49 provider and member education 50–1 quality measurement 51 use of generics 48–9 managed care pharmacy tools 38–9 aids to formulary decision-making 42–3 contract negotiations 45–7 drug utilization review 44–5 formularies 39–42 formulary management tools 43–4 provider and member education 47 quality measurement 48 use of generics 39 managed care systems 8, 10–11, 29–31, 35–6 drug distribution 237 health maintenance organizations 37 integrated delivery systems 37–8 454 Index interaction with pharmaceutical manufacturers 229 Medicare Advantage program 182 pharmacy benefit management companies 38 point-of-service (POS) plans 37 preferred provider organizations 37 public health care sector 15 TRICARE 12 market segmentation 84–5, 87 market share rebate arrangements 46 marketing 76 pharmaceutical companies 139 off-label promotion 140–1 physician inducements 139–40 marketing mix 228 mass merchandiser pharmacies 78–9 distribution of drugs 235 meaningful use, health information technology 391–3 medex (MX), prescribing authority 55 Medicaid 7, 14–16 drug costs 128, 136–7 foundation 155 funding sources 26 payment for nursing facility services 191 prospective payment system waiver programs 201 medical education 54–5 role of federal hospitals 169 medical errors 156, 173–4, 297 patient safety organizations 175–6 reduction strategies 169 bar coding 240 health information technology 388, 389 see also medication errors medical staff, hospitals 162–3 Medicare 7, 16 distribution of spending 183 drug costs 128 coverage of 182–3 foundation 155 funding sources 24–6 growing expenditure 22, 23 MTM services 125 payment for nursing facility services 191 payment for skilled nursing facilities 192 Prescription Drug Plans 141–3 prospective payment system waiver programs 201 Medicare Drug Improvement and Modernization Act (MMA) 2003 389, 390–1, 406 Medicare Improvements for Patients and Providers Act (MIPPA) 2008 389, 391 Medication Appropriateness Index (MAI) 187 medication counseling 47 medication errors 292–3, 294 reduction strategies 310 premarket revisions 299 role of consultant pharmacists 187–8 reporting of 298 see also adverse drug events; medical errors medication guide distribution 306 enforcement discretion 307 medication management standards 308–9 medication passes, “wrong-time” errors 187–8 medication response, ethnic variations 345–6 medication safety 174, 310 medication therapy management (MTM) 75, 80–1, 124–5, 427–8 professional activities 81 suitability for older population 199–200 medication therapy review (MTR) 75, 81–3, 82 application of marketing concepts 84 market segmentation 84–5 personal selling 85–6 relationship marketing 86–7 case analysis 87–90 outcomes 83–4 medication use evaluation/ management see drug utilization review (DUR) Medicine Equity and Drug Safety Act, 2000 137 Index MediGap plans 16 MedWatch 300–1 meetings, sponsorship by pharmacy organizations 96–7 member education, managed care systems 47 mental health services 10 mentally challenged, intermediate care facilities 202 mergers and acquisitions, pharmaceutical industry 221–2 metabolism, ethnic variations 274, 345–6 Mexican population 275–6 midwives, prescribing authority 54, 56 military medical care system 12, 168–9 Minimum Data Set (MDS) 195–6 monographs 97 morals 374 mortality rates, decreasing 180 multidisciplinary approach, interprofessional education 435 multidisciplinary certification programs 121–2 multihospital systems, rural hospitals 170 mutual participation model 257–8 National Association of Boards of Pharmacy (NABP) 109 National Association of Chain Drug Stores (NACDS) 107 National Center for Advancing Translational Sciences (NCATS) 145 National Commission for Health Certifying Agencies 59 National Committee on Vital and Health Statistics (NCVHS) 401 National Community Pharmacists Association (NCPA) 100–1 National Council for Prescription Drug Programs (NCPDP) 398 national health information network (NHIN) 397, 405, 406 National Patient Safety Foundation (NPSF) 175 National Pharmaceutical Association (NPhA) 102 455 National Pharmaceutical Council (NPC) 107 national practitioner pharmacy organizations 100–3 websites 112–13 National Quality Forum 312 national trade organizations 106, 106–8 websites 113 Native Hawaiian and Pacific Islander population growth, projections 326–7 as percentage of registered nurse population 336, 337 pharmacy graduation, trends 338–40 natural law 369 need arousal, individual consumer behavior model 260–1 need–payoff questions 86, 89 needs hierarchical model 261 of patients 265 Neighborhood Health Centers (NHCs) 13 network pharmacies, contract negotiations 45–6 networking 96, 380 local pharmacy organizations 105 new drug applications advisory committees 131 review times 130–1 niche areas, pharmaceutical industry 224 noncompliance see compliance nonmaleficence 370, 371 not-for-profit hospitals 166–7 nuclear pharmacy 63 nurse practitioners (NPs) 163 prescribing authority 54, 55, 56 nurses employment in hospitals 163–4 training 164 nursing facilities (NFs) 190–1 medication finances 198–9 Minimum Data Set (MDS) 195–6 quality indicators 196 quality measures 196–7 role of geriatric pharmacists 193, 197 drug regimen review 193–5 skilled 192 456 Index Nursing Home Reform Act, 1987 195 nursing homes, medication errors 187–8 nutrition support pharmacy 63 obesity rate 33 Office of the National Coordinator for Health Information Technology (ONCHIT) 401, 406 off-label use of drugs in nursing facilities 199 promotion by manufacturers 140–1 “old-old” 180 medication usage 185 older population 207–8 barriers to health care 185–6 Commission for Certification in Geriatric Pharmacy 121 drug costs, Medicare coverage 182–3 drug errors 292–3 drug-related problems 186–7 health care usage 181–2, 184 medication usage 184–5, 291–2 impact of health care reform 183 increasing size 77, 179–81 Medicare 16 medication appropriateness 187–8 packaging issues 234 see also geriatric pharmacy; long-term care Omnibus Budget Reconciliation Act (OBRA), 1987 195 oncology pharmacy 63 online pharmacies 237–8 Online Survey, Certification, and Reporting System (OSCAR) 195–6 open formularies 40 optometrists (OD), prescribing authority 54, 55 optometry training attainment of First Professional degree by ethnic category 333 enrollment of ethnic minorities 329, 330, 335 Organizational Supports for Cultural Competence, CLAS Standards 343–4 orphan drugs 229 osteopathic medicine training 54–5 attainment of First Professional degree by ethnic category 332 enrollment of ethnic minorities 329, 330, 335 outcomes research 42–3 outpatient care choices 247 expenditure 166 over-the-counter (OTC) drug market 222 over-the-counter (OTC) drug usage 283, 284, 286–7 decision-making process 348–51, 350 influence of pharmacists 348 older population 184, 185 ownership of work 380 packaging of drugs 233–5 impact on compliance 290 for older population 252 pain management, in hospice setting 207 pain relievers, abuse of 293 pain response, cultural differences 347 Pap smears, cultural issues 276 paradigm shift in pharmacy practice 413–15 see also clinical pharmacy Pareto principle 181–2 partial compliance 288 part-time working, role in pharmacist shortage 77–8 passive informed consent 372 patent laws 130, 132–3, 147, 221 biotechnology drugs 134–5 Hatch–Waxman Act 133 impact of genomics 146 impact on pharmaceutical industry 219 perennial concerns 135 paternalism 255, 370, 371 patient-centered care 176, 246 patient-centered integrated model, hospital pharmacy practice 164 patient-centered medical homes (PCMHs) 395, 428, 431–2 interprofessional education 435–6 Patient Centered Outcomes Research Institute (PCORI) 220 Index patient counseling information, USP Dispensing Information 108 patient medication profiling, limitations 284 patient–practitioner relationship 255–6 causes of problems 258, 265 continuum of decision-making responsibility 255 fiduciary relationship model 256–8 individual consumer behavior model 260–4 pharmacy code of ethics 363–4 sick role behavioral model 258–9 patient safety 173–4, 297 pharmacist’s role 309–11 pharmacovigilance 298 post-marketing surveillance 300–3 premarket assessment of drugs 299–300 regulatory requirements 308–9 resources 311–12 risk management 303–8 role of health information technology 388, 389 see also medical errors; medication errors patient safety organizations 175–6 pay-for performance methodology, CMS 309 pediatric hospitals 170 penicillin, discovery permits to practice 59 personal health records (PHRs) 387, 389, 406, 408–9 personal selling 76, 84, 85–6 case analysis 89–90 personalized medicine 42, 434 political issues 144–6 pharmaceutical care 11, 75 role expansion 78 see also emerging roles Pharmaceutical Care Management Association 107–8 pharmaceutical case management (PCM) program 82–3, 87 pharmaceutical industry 215 benefits to society 230 clustering 218–19 457 consolidation 218, 221–2, 224 criticisms of 217–18 developing markets 223 distribution of drugs 229 economic impact 215–17 future prospects 224–5 generic drug manufacturing 222–3, 223–4 global partnerships 223 “high-tech recycling” 224 impact of pricing regulations 219 marketing 139 off-label promotion 140–1 physician inducements 139–40 over-the-counter drug market 222 pressure on drug prices 223 public attitudes towards 219 rebate agreements 46–7 research and development 219–21 conflicts of interest 138–9 costs 129 segments 218 Pharmaceutical Research and Manufacturers of America (PhRMA) 107 pharmaceutical sales, trends 228–9 pharmacist prescribing 56–7 vaccines and drugs for adverse reactions 72 pharmacist shortage contributing factors 76–8 impact 78 responses to 78 Pharmacist/Pharmacy Provider Electronic Health Record 399 pharmacist–physician collaboration 86–7 case analysis 90 collaborative drug therapy management (CDTM) 122–4 pharmacists employment in hospitals 164–5 personnel and practice sites 60, 62–3 practice settings 78–80 specialization 63–4 see also consultant pharmacists pharmacists’ role, political aspects 143–4 pharmacoeconomics 43, 65 458 Index pharmacotherapy 63 pharmacovigilance 297–8 pharmacist’s role 309–11 post-marketing surveillance 300–3 premarket assessment of drugs 299–300 regulatory requirements 308–9 resources 311–12 risk management 303–8 Pharmacovigilance Planning, E2E 304 pharmacy and therapeutic (P&T) committees 41 pharmacy benefit managers (PBMs) 11, 38 interaction with pharmaceutical manufacturers 229 role and politics 135–6 pharmacy code of ethics 363–4 history of 362 purpose 364–5 Pharmacy e-Health Information Technology Collaborative 404–5 pharmacy graduates, ethnic minorities, trends 338–40 pharmacy informatics 65 pharmacy issues and trends auxiliary personnel 65–6 employment 64–5 impact of technology 66 political and economic impacts 66 Pharmacy Manpower Project Inc 60 Aggregate Demand Index (ADI) 76–7 pharmacy organizations 99–100 education, regulatory, and foundation organizations 108–10 historical development 99 individual participations decisions 111–12 local organizations 105–6 multiplicity of organizations 110–11 national practitioner organizations 100–5 national trade organizations 106–8 role 95 for the profession and individual practitioners 96–8 for society 98 state organizations 105 Pharmacy Quality Alliance (PQA) 48 pharmacy selection, influencing factors 349–51 pharmacy services, Community Health Centers 14 pharmacy technicians 65–6, 165 responsibilities 422 pharmacy training see education PharmD degree 117 PharmD programs, expansion 78 PhD studies 117 Phi Delta Chi 104 Phi Lambda Sigma 104 Philadelphia College of Pharmacy 99 physical fitness, Healthy People 2020 objectives 2–3 physician assistants (PAs) 163 prescribing authority 54, 55, 56 physician–hospital organizations see integrated delivery systems (IDSs) Physician Quality Reporting Initiative (PQRI) 391 physician training, Flexner Report, 1910 physicians employment in hospitals 163 gatekeeper role 245 inducements from pharmaceutical companies 139–40 medical education 54–5 percentage in ethnic minorities 336, 338 specialization 59–60 physiological needs 261 podiatric medicine training attainment of First Professional degree by ethnic category 334 enrollment of ethnic minorities 329, 330, 335 podiatrists, prescribing authority 54, 55 point-of-service (POS) plans 30–1, 37 policy-making, role of pharmacy organizations 98 political issues 127–8, 144–6 cost control 129–30 effect of direct-to-consumer advertising 138 Medicaid drug costs 136–7 reimportation and international pricing 137–8 Index genetics and personalized medicine 144–6 legislation Food and Drug Administration 130–1 herbal remedies 131–2 intellectual property 132–5 looking ahead 146–7 Medicare coverage, Prescription Drug Plans 141–3 pharmaceutical industry research 138–9 pharmaceutical company marketing 139–41 private prescription insurance 135 pharmacy benefit managers 135–6 role of pharmacists 143–4 polypharmacy adverse drug events 186 nursing home residents 190 older population 77, 184 population demographics 319–21, 432–3 population growth 325, 328 projections by race and age 326–7 proportion of ethnic minorities 318, 323 trends 318 by region and state 322–3 positioning strategies 85, 86 case analysis 88 post-decision assessment, individual consumer behavior model 260, 264 postgraduate education and training 117 postmarketing commitment (PMC) 301 postmarketing surveillance 300–3, 308 practice-based continuing pharmacy education 118–19 practice management systems (PMSs) 385 practice settings, pharmacists 78–80 practitioner utilization audits 47 preferred provider organizations (PPOs) 10–11, 30, 37 premarket assessment of drugs 299–300 “premium-priced packages” 250 459 prepackaging 233–4 prescribing authority 54–6 controlled drugs 66–8 pharmacists 56–7 prescription benefit programs 11 Prescription Drug Plans (PDPs) 141–3 Prescription Drug User Fee Act, 1992 130 prescription insurance coverage 128–9, 284, 285 Medicare Part D 183 prescription medicines, expenditure 166 prevention 246–7 health belief model 266–7 preventive services impact of health care reform 183 participation levels 264–5 pricing regulations European countries 223 impact on pharmaceutical industry 219, 221 pricing strategies 228 primary care physicians (PCPs) 30 prior authorization programs, managed care systems 44 private health care sector long-term care 10 managed care 10–11 mental health services 10 pharmaceutical care 11 prescription benefit programs 11 private health insurance 28–9 fee-for-service plans 29 managed care systems 29–31 private prescription insurance 135 pharmacy benefit managers 135–6 Probability of Repeated Admission (PRA) 182 probing questions 86, 89 problem questions 86 processing-resource theory 253 professional fidelity 372 professional identity 96 professional status 53 professionalism 365, 367–8 behavioral characteristics 380–2 caring 382 definition and traits 377–80 relationship to ethics 365 unprofessional conduct 366–7 460 Index prognosis, patients’ perceptions of 269 program (specialized) accreditation 58 Program for All-Inclusive Care for the Elderly (PACE) 203–5 Promacta 346 promotion of pharmacy, role of pharmacy organizations 97–8 promotion of products 228 prospective DUR 45, 50 prospective payment systems skilled nursing facilities 192 protocols 35–6 Provenge, cost 132 provider education, managed care systems 47 psychiatric pharmacy 63 psychological aging 253–4 psychologists, prescribing authority 56 psychotherapeutic drug abuse 293 psychotropic medications drug regimen review 194 ethnic variations in response 346 public financing 22–3 Children’s Health Insurance Program 28 distribution of government health funds 23 Federal Employees Health Benefit Plan 27–8 Indian Health Service 27 Medicaid 26 Medicare 24–6 TRICARE 27 Veterans Administration (VA) system 26–7 public health care sector federal government agencies 17 federal government-provided care Community Health Centers 13–14 Indian Health Service 12–13 military medical care 12 local government-provided care 14 Medicaid 14–16 Medicare 16 Public Health training, enrollment of ethnic minorities 329 public service 379 publications 97 Puerto Rican population 275 reducing numbers 323 quality indicators (QIs), nursing facilities 196 quality measurement 48 role of managed care pharmacists 51 quality measures (QMs), nursing facilities 196–7 quantity limits 44 racial minorities see ethnic minorities regional extension centers (RECs) 394 registered nurses, percentage of ethnic minorities 336, 337 registered nursing training, enrollment of ethnic minorities 329, 330 registration of individuals 58–9 regulation of pharmaceuticals, origins 127 regulations see legislation reimbursement of pharmacists, compensation for extended role 144, 421, 431–2 reimportation 137, 221 relationship marketing 84, 86–7 repackaging 233–4 research and development 219–20, 436 conflicts of interest 138–9 impact of reimportation 221 intellectual property rights 221 use of health information technology 403–4 research pharmacists 65 residency programs 117–18, 165 Resident Assessment Instrument (RAI) 195 resource distribution, justice 373 resource utilization groups (RUGs), skilled nursing facilities 192 responsibilities, professional 378–9, 380, 381 restricted drug distribution systems 240–1 retrospective DUR 45, 50 return on investment (ROI), compliance interventions 290–1 Rho Chi 104–5 right to health care 17–18 rights 374 risk assessment tools 311–12 Index risk evaluation and mitigation strategies (REMS) 301–2, 305–6 impact on pharmacists 306–7 risk factors 1, 4, 4–5 risk management 303–8 risk minimization action plans (RiskMAPs) 301, 304 comparison with REMs 305 risk sharing (risk pooling) 22 “Roadmap for Pharmacy Health Information Technology Integration in U.S Health Care” 404–5 robotics, impact on health care 66 role of pharmacists political aspects 143–4 see also emerging roles root cause analysis (RCA) 311–12 rural hospitals 169–70 safety concerns internet pharmacies 237–8 see also patient safety; patient safety organizations safety needs 261 safety net hospitals 155 salaries 421 screening, Probability of Repeated Admission (PRA) tool 182 sedatives, abuse of 293 segmentation see market segmentation self-actualization needs 261 self-care 123, 270–1, 286 older population 185 self-consistency motive 253 self-diagnosis 264 self-medication 286–7 decision-making process 348–51, 350 influence of pharmacists 348 self-regulation, pharmacy profession 379–80 senior citizens see older population Sentinel Initiative 302 service organization, hospitals 161 sick, care of 271–2 sickness career 267, 269 sick-role behavior 258–9, 266, 267, 269 health belief model 268 461 situation questions 85, 89 skilled nursing facilities (SNFs) 192 social aging 254, 255 social contract model, patient–practitioner relationship 256 social needs 261 social welfare, role of pharmacy organizations 98 Soliris, cost 132 special needs plans (SNPs) 203 specialization pharmacists 63–4 physicians 59–60, 61 specialized (program) accreditation 58 specialty hospitals 168, 170 specialty pharmaceuticals, distribution 240–2 standards, professional 381 standards development organizations (SDOs) 397–8 state pharmacy organizations 105 step therapy 43–4 stimulants, abuse of 293 sulfanilamide, elixir of 127 supermarket pharmacies 79 supply chain 227 symptoms, patients’ perceptions of 269 target market selection 85 Task Force on Risk Management 303–4 Tax Relief and Health Care Act 2006 391 teams, comparison with working groups 436 technology 433–5 application in hospitals 155, 156 automation 239–40 electronic health records (EHRs) 225 impact on health care 66, 248 reduction of drug errors 292, 294 role in pharmacy practice 125, 239 as source of ethical dilemmas 361, 365 see also health information technology telemedicine 251, 402–3, 434 thalidomide 127 The Joint Commission (TJC) 172 The Joint Commission (TJC) Accreditation Manual for Hospitals 157 462 Index therapeutic guidelines see protocols tiered copayments 40–1, 47, 136 advisory role of pharmacists 49 “To Err Is Human,” Institute of Medicine, 1999 173, 297 tolerance, individual variations 269 total compliance 288 traineeships 119 training of pharmacists see education tranquilizers, abuse of 293 transformation of pharmacy practice 413–15 see also clinical pharmacy; future directions treatment outcome variations, ethnic minorities 345–6 TRICARE 12 funding sources 27 tuberculosis, reduced mortality 5, uninsured health care provision 14 Medicaid 14–16 prescription costs 128–9 United States Pharmacopoeia-National Formulary 108 Unites States Pharmacopeial Convention (UPS) 108 unit-of-use packaging 233–4 universal coverage 17 unprofessional conduct 365–8 reporting of 380 utilitarianism 369 vaccinations Medicare coverage 182 pharmacist prescription and administration 56–7, 72, 124 Vaccine Adverse Event Reporting System (VAERS) 300 value chain 227, 228 value in health care 426 demonstration of 429–31 paying for 431–2 provision of 426–9 values 373–4 veracity 371, 372 Verified Internet Pharmacy Practice Site (VIPPS) program 238 Veterans Administration (VA) system 12 VA hospitals 168–9 Veterans Affairs Health Care System (VA) system, funding sources 26–7 veterinarians (DVM), prescribing authority 54, 55 veterinary training attainment of First Professional degree by ethnic category 334 enrollment of ethnic minorities 330 Vioxx 127 virtue theory of ethics 369 virtues 373 vitamin supplements, usage by older population 185 wage rates, relationship to practice setting 80 wants, distinction from needs 261 wellness 267 wholesalers, role in drug distribution 230–2 willingness-to-pay (WTP) 432 withdrawal of products 300, 301, 303 women, older population 179 women’s health concept 277 women’s interests, Kappa Epsilon 104 work activities, relationship to practice setting 80 workforce diversity 317, 325, 353 advantages 340–1 in pharmacy practices 347 working groups, comparison with teams 436 “wrong-time” errors 187–8 Zyprexa, cost 132–3 UPLOADED BY [STORMRG] ... www.pharmpress.com/alerts Pharmaceutical Press is the publishing division of the Royal Pharmaceutical Society Pharmacy and the US Health Care System FOURTH EDITION Editors Michael Ira Smith PhD President MIS Pharmaceutical... medication therapy management (MTM) and disease state management 12 Pharmacy and the US Health Care System Summary The distinctive feature of the private health care system is that the consumer has the. .. afford them, and the disparity in life expectancy between Caucasians and other racial groups in the United States Our US system is characterized by the overlapping, unplanned, and wasteful use of