Pharmaceutical Systems

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.

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