Pharmaceutical Systems
Global Perspectives
Published on 21. April 2008
Book
Paperback/Softback
356 pages
978-0-470-72567-2 (ISBN)
Description
Offers a social view of the activities leading to the timely patient access to medicines including: drug research, drug production, drug distribution, drug prescribing, drug information and drug control
Provides theoretical models to enable pharmacists to understand the organization of drug systems in their particular global territory
Written specifically with the needs of pharmacy students taking Master's degrees in mind
Provides theoretical models to enable pharmacists to understand the organization of drug systems in their particular global territory
Written specifically with the needs of pharmacy students taking Master's degrees in mind
More details
Language
English
Place of publication
New York
United States
Target group
Professional and scholarly
Dimensions
Height: 243 mm
Width: 168 mm
Thickness: 20 mm
Weight
608 gr
ISBN-13
978-0-470-72567-2 (9780470725672)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
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E-Book
08/2008
Wiley
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04/2008
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Persons
Professor John Lilja, Department of Social Pharmacy, Finland.
Professor Sam Salek, Reader in Pharmacoepidemiology; Director - WSP Centre for Socioeconomic Research; Director - Postgraduate Course in Pharmaceutical Medicine Cardiff University, UK.
Dr Aldo Alvarez, San Marcos University, Lima, Peru,
Dr David Hamilton, Widening Participation Service, Glasgow University, Glasgow.
Professor Sam Salek, Reader in Pharmacoepidemiology; Director - WSP Centre for Socioeconomic Research; Director - Postgraduate Course in Pharmaceutical Medicine Cardiff University, UK.
Dr Aldo Alvarez, San Marcos University, Lima, Peru,
Dr David Hamilton, Widening Participation Service, Glasgow University, Glasgow.
Content
Preface ix
About the authors xi
1 Introduction 1
1.1 Economic development 1
1.2 Systems analysis 3
1.3 Actors in the pharmaceutical systems 8
1.4 Evaluations 17
1.5 Data collection 20
1.6 Summary of results and formulation of conclusions 20
1.7 Social constructionism and social representation theory 21
1.8 The actor-spectator paradox 25
1.9 Decision-making processes in the drug system 26
1.10 How attitudes and beliefs change - the balance model 29
1.11 Summary 32
References 33
2 A historical perspective of drug research and diffusion 39
2.1 The period of folk medicine 39
2.2 The merchant period (1500 AD to the end of the eighteenth century) 39
2.3 The chemical period (the nineteenth century) 44
2.4 The animal testing period (from 1900 to the end of the 1930s) 47
2.5 The drug innovation period (from 1940 to 1964) 49
2.6 The post-Thalidomide period (1965 to present) 51
2.7 Future perspectives 56
2.8 Summary 56
References 57
3 National drug policies 61
3.1 Efficient organization of drug support 62
3.2 Efficient organization of drug research 63
3.3 Efficient organization of drug production 65
3.4 Efficient organization of drug distribution 66
3.5 An efficient system for drug consumption 68
3.6 A satisfactory system of drug information 69
3.7 Choice of drugs with high therapeutic powers 70
3.8 Choice of drugs with few side effects 75
3.9 Low drug costs 77
3.10 How to develop and implement a national policy 77
3.11 Summary 78
References 78
4 Planning the drug support 81
4.1 Patent and exclusivity policies 81
4.2 Trade name policy vs. generic name policy 84
4.3 Generic and therapeutic substitution 85
4.4 Generic prescribing 87
4.5 Drug registration 88
4.6 Drug reimbursement policies/national health insurance systems 90
4.7 The public and private drug sectors of developing countries 93
4.8 The primary health care policy 95
4.9 The essential drugs (ED) policy 99
4.10 Summary 102
References 103
5 Drug research 109
5.1 Drug company strategies 110
5.2 Factors which determine the resources a drug company spends on R&D 112
5.3 The selection of research areas by a drug company 115
5.4 The research process 116
5.5 The project decision 118
5.6 The research administration after a project has been accepted 120
5.7 Research productivity 122
5.8 Ethical concerns in drug research 124
5.9 Summary 125
References 126
6 Drug production 129
6.1 Background 129
6.2 Variations between countries 133
6.3 The decision regarding which drug(s) to produce 134
6.4 The organization of production lines 139
6.5 Production of drug raw materials 141
6.6 Drug quality 142
6.7 Principles of technical assistance support 144
6.8 The decision where to locate the plant 145
6.9 Determination of production quantities 146
6.10 Export decisions 146
6.11 Summary 147
References 148
7 Drug prices, cost controls and profits in the drug industry 151
7.1 Price setting of raw drug materials 151
7.2 Price setting of ready-made drugs 154
7.3 Price setting of patented drugs 156
7.4 Price setting of non-patented drugs (generic drugs) 157
7.5 Price Competition 158
7.6 Cost controls 160
7.7 The prices a patient has to pay in the public sector in countries which have a public distribution system 163
7.8 Drug prices at private pharmacies in developing countries 164
7.9 The profits of drug companies 164
7.10 Summary 166
References 167
8 Drug wholesaling and procurement 171
8.1 Importation 172
8.2 Different types of wholesale systems 173
8.3 How to evaluate a wholesaling system 174
8.4 Procurement 176
8.5 Summary 178
References 178
9 Drug retail distribution 181
9.1 Pharmaceutical care 182
9.2 The degree of formal government control of outpatient pharmacies 184
9.3 Drug distribution aims 188
9.4 Summary 200
References 200
10 Drug consumption 205
10.1 Historical perspective 205
10.2 Measurement of drug consumption 206
10.3 Factors which determine the volume of a drug consumed in a country 209
10.4 Factors found to be related to the volume of drug consumption 211
10.5 Factors which influence drug consumption at the individual level 213
10.6 Qualitative studies of drug consumption 215
10.7 Summary 216
References 217
11 Marketing of drugs 219
11.1 Historical background 219
11.2 The contextual factors which affect the diffusion of a drug 221
11.3 The marketing goals of drug companies 222
11.4 Factors determining what a drug company spends on the marketing of a new drug 223
11.5 The relative effects of different media and messages in commercial drug information to prescribers 228
11.6 Commercial media directed at the general public 230
11.7 A national perspective on commercial drug information 230
11.8 Summary 233
References 233
12 The market structure 237
12.1 The existing international market structure 237
12.2 The market structure in a specific country 239
12.3 Summary 240
References 241
13 Drug control 243
13.1 Definition of drug control 243
13.2 Process model of the drug control system in a country 244
13.3 The processes to ensure that each aspect of drug control complies with the necessary norms or standards 247
13.4 Control measures 248
13.5 Clinical trials 251
13.6 Summary 251
References 252
14 Drug prescribing 255
14.1 Normative studies 255
14.2 Sociological studies 258
14.3 Information process studies of drug prescribing 260
14.4 Prescription studies based on a cognitive perspective 262
14.5 How standard selections change 267
14.6 Making a diagnosis 268
14.7 Placebo prescribing 269
14.8 Summary 270
References 271
15 Patients' attitudes and behaviour 277
15.1 Background 277
15.2 Explanatory models 278
15.3 A process model: how a layperson deals with medical symptoms 280
15.4 OTC drugs 288
15.5 Patient compliance 289
15.6 Summary 294
References 294
16 Drug information 301
16.1 Background 301
16.2 The role of mass media 303
16.3 Drug information sources used 305
16.4 Drug information from a sender's perspective 308
16.5 Mass media campaigns 313
16.6 The value problem 314
16.7 Summary 315
References 316
Index 319
About the authors xi
1 Introduction 1
1.1 Economic development 1
1.2 Systems analysis 3
1.3 Actors in the pharmaceutical systems 8
1.4 Evaluations 17
1.5 Data collection 20
1.6 Summary of results and formulation of conclusions 20
1.7 Social constructionism and social representation theory 21
1.8 The actor-spectator paradox 25
1.9 Decision-making processes in the drug system 26
1.10 How attitudes and beliefs change - the balance model 29
1.11 Summary 32
References 33
2 A historical perspective of drug research and diffusion 39
2.1 The period of folk medicine 39
2.2 The merchant period (1500 AD to the end of the eighteenth century) 39
2.3 The chemical period (the nineteenth century) 44
2.4 The animal testing period (from 1900 to the end of the 1930s) 47
2.5 The drug innovation period (from 1940 to 1964) 49
2.6 The post-Thalidomide period (1965 to present) 51
2.7 Future perspectives 56
2.8 Summary 56
References 57
3 National drug policies 61
3.1 Efficient organization of drug support 62
3.2 Efficient organization of drug research 63
3.3 Efficient organization of drug production 65
3.4 Efficient organization of drug distribution 66
3.5 An efficient system for drug consumption 68
3.6 A satisfactory system of drug information 69
3.7 Choice of drugs with high therapeutic powers 70
3.8 Choice of drugs with few side effects 75
3.9 Low drug costs 77
3.10 How to develop and implement a national policy 77
3.11 Summary 78
References 78
4 Planning the drug support 81
4.1 Patent and exclusivity policies 81
4.2 Trade name policy vs. generic name policy 84
4.3 Generic and therapeutic substitution 85
4.4 Generic prescribing 87
4.5 Drug registration 88
4.6 Drug reimbursement policies/national health insurance systems 90
4.7 The public and private drug sectors of developing countries 93
4.8 The primary health care policy 95
4.9 The essential drugs (ED) policy 99
4.10 Summary 102
References 103
5 Drug research 109
5.1 Drug company strategies 110
5.2 Factors which determine the resources a drug company spends on R&D 112
5.3 The selection of research areas by a drug company 115
5.4 The research process 116
5.5 The project decision 118
5.6 The research administration after a project has been accepted 120
5.7 Research productivity 122
5.8 Ethical concerns in drug research 124
5.9 Summary 125
References 126
6 Drug production 129
6.1 Background 129
6.2 Variations between countries 133
6.3 The decision regarding which drug(s) to produce 134
6.4 The organization of production lines 139
6.5 Production of drug raw materials 141
6.6 Drug quality 142
6.7 Principles of technical assistance support 144
6.8 The decision where to locate the plant 145
6.9 Determination of production quantities 146
6.10 Export decisions 146
6.11 Summary 147
References 148
7 Drug prices, cost controls and profits in the drug industry 151
7.1 Price setting of raw drug materials 151
7.2 Price setting of ready-made drugs 154
7.3 Price setting of patented drugs 156
7.4 Price setting of non-patented drugs (generic drugs) 157
7.5 Price Competition 158
7.6 Cost controls 160
7.7 The prices a patient has to pay in the public sector in countries which have a public distribution system 163
7.8 Drug prices at private pharmacies in developing countries 164
7.9 The profits of drug companies 164
7.10 Summary 166
References 167
8 Drug wholesaling and procurement 171
8.1 Importation 172
8.2 Different types of wholesale systems 173
8.3 How to evaluate a wholesaling system 174
8.4 Procurement 176
8.5 Summary 178
References 178
9 Drug retail distribution 181
9.1 Pharmaceutical care 182
9.2 The degree of formal government control of outpatient pharmacies 184
9.3 Drug distribution aims 188
9.4 Summary 200
References 200
10 Drug consumption 205
10.1 Historical perspective 205
10.2 Measurement of drug consumption 206
10.3 Factors which determine the volume of a drug consumed in a country 209
10.4 Factors found to be related to the volume of drug consumption 211
10.5 Factors which influence drug consumption at the individual level 213
10.6 Qualitative studies of drug consumption 215
10.7 Summary 216
References 217
11 Marketing of drugs 219
11.1 Historical background 219
11.2 The contextual factors which affect the diffusion of a drug 221
11.3 The marketing goals of drug companies 222
11.4 Factors determining what a drug company spends on the marketing of a new drug 223
11.5 The relative effects of different media and messages in commercial drug information to prescribers 228
11.6 Commercial media directed at the general public 230
11.7 A national perspective on commercial drug information 230
11.8 Summary 233
References 233
12 The market structure 237
12.1 The existing international market structure 237
12.2 The market structure in a specific country 239
12.3 Summary 240
References 241
13 Drug control 243
13.1 Definition of drug control 243
13.2 Process model of the drug control system in a country 244
13.3 The processes to ensure that each aspect of drug control complies with the necessary norms or standards 247
13.4 Control measures 248
13.5 Clinical trials 251
13.6 Summary 251
References 252
14 Drug prescribing 255
14.1 Normative studies 255
14.2 Sociological studies 258
14.3 Information process studies of drug prescribing 260
14.4 Prescription studies based on a cognitive perspective 262
14.5 How standard selections change 267
14.6 Making a diagnosis 268
14.7 Placebo prescribing 269
14.8 Summary 270
References 271
15 Patients' attitudes and behaviour 277
15.1 Background 277
15.2 Explanatory models 278
15.3 A process model: how a layperson deals with medical symptoms 280
15.4 OTC drugs 288
15.5 Patient compliance 289
15.6 Summary 294
References 294
16 Drug information 301
16.1 Background 301
16.2 The role of mass media 303
16.3 Drug information sources used 305
16.4 Drug information from a sender's perspective 308
16.5 Mass media campaigns 313
16.6 The value problem 314
16.7 Summary 315
References 316
Index 319