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. 1. Introduction. 1.1 Economic development. 1.2 Systems analysis. Contextual Factors Which Influence a National Pharmaceutical System. 1.3 The actors in the pharmaceutical systems. Health care professional groups. Drug producers. Drug control. Patients and their organizations. 1.4 Evaluations. Deciding about the aim of the evaluation. The identification of the system and its goals. The identification of the evaluation dimensions and the decision on how to measure these dimensions. 1.5 The collection of data. 1.6 The summary of the results and the formulation of conclusions. 1.7 Social constructionism and social representation theory. 1.8 The actor-spectator paradox. 1.9 The decision-making processes in the drug system. 1.10 How attitudes and beliefs change - the balance model. 1.11 Summary of the chapter. References. 2. A historical perspective of drug research and diffusion. 2.1 The period of folk medicine. 2.2 The merchant period (1500 AD to the end of the eighteenth century). 2.3 The chemical period (the nineteenth century). 2.4 The animal testing period (from 1900 to the end of the 1930s). 2.5 The drug innovation period (from 1940 to 1964). 2.6 The post-Thalidomide period (1965 to present). 2.7 Future perspectives. 2.8 Summary of the chapter. References. 3. National drug policies. 3.1 Efficient organization of drug support. 3.2 Efficient organization of drug research. 3.3 Efficient organization of drug production. 3.4 Efficient organization of drug distribution. 3.5 An efficient system for drug consumption. 3.6 An efficient system of drug information. 3.7 Choice of drugs with high therapeutic powers. 3.8 Choice of drugs with few side effects. 3.9 Low drug costs. 3.10 How to develop and implement a national policy. 3.11 Summary of the chapter. References. 4. Planning the drug support. 4.1 Patent and exclusivity policies. 4.2 Trade name policy vs. generic name policy. 4.3 Generic and therapeutic substitution. 4.4 Generic prescribing. 4.5 Drug registration. 4.6 Drug reimbursement policies/national health insurance systems. 4.7 The public and private drug sectors of developing countries. 4.8 The primary health care policy. 4.9 The essential drugs policy. 4.10 Summary of the chapter. References. 5. Drug research. 5.1 Drug company strategies. Drug companies focusing on research to find new chemical substances intended for the international market . Drug companies concentrating on efficient drug chemical production (bulk production). Companies concentrating on the marketing of non-patented ready-made drugs (generic production). Drug companies concentrating on the marketing of drugs for self-medication. Drug companies concentrating on the sales of herbal medicines. 5.2 Factors which determine the resources a drug company spends on R&D. 5.3 The selection of research areas by a drug company. 5.4 The research process. 5.5 The project decision. 5.6 The research administration after a project has been accepted . 5.7 Research productivity. 5.8 Ethical concerns in drug research. 5.9 Summary of the chapter. References. 6. Drug production. 6.1 Background. 6.2 Variations between countries. 6.3 The decision regarding which drug(s) to produce . Production considerations. Marketing considerations. 6.4 The organization of production lines. 6.5 Production of drug raw materials. 6.6 Drug quality. 6.7 The principles of technical assistance support. 6.8 The decision where to locate the plant. 6.9 The determination of production quantities. 6.10 Export decisions. 6.11 Summary of the chapter. References. 7. Drug prices, cost controls and profits in the drug industry. 7.1 The price setting of raw materials. 7.2 The price setting of ready-made drugs. 7.3 The price setting of patented drugs. 7.4 The price setting of non-patented drugs (generic drugs). 7.5 Price Competition. 7.6 Cost controls. Cost control agencies which do not negotiate on drug prices. Agencies which negotiate with drug companies about drug prices and accept 'reasonable' quotations. Agencies which negotiate about drug prices and only accept the cheapest (or a number of the cheapest) drug(s) fulfilling a specific medical need. 7.7 The prices a patient has to pay in the public sector in countries which have a public distribution system. 7.8 Drug prices at private pharmacies in developing countries. 7.9 Drug prices at private pharmacies in developing countries. 7.10 Summary of the chapter. References. 8. Drug wholesaling and procurement. 8.1 Importation. 8.2 Different types of wholesale systems. 8.3 How to evaluate a wholesaling system. 8.4 Procurement. 8.5 Summary of the chapter. References. 9. Drug retail distribution. 9.1Pharmaceutical care. 9.2 The degree of formal government control of outpatient pharmacies. State owned systems. Private systems with government control of drug prices and of the locations of pharmacies . Private systems with state control of drug prices without location control. Private systems without state control of drug prices and of the locations of new pharmacies. 9.3 Drug distribution aims. Short travel times to the pharmacy service. A satisfactory range of drug preparations. Convenient opening hours. Safety. Short waiting times for customers. Drug information and customer-pharmacy staff interactions. Suitable working conditions. Ethical considerations. Cooperation with other sectors of the health care system. Low drug prices in the pharmacy. An efficient organization. 9.4 Summary of the chapter. References. 10. Drug consumption. 10.1 A historical perspective. 10.2 Measurement of drug consumption. Sales value in monetary terms. The weight of the drugs consumed. Number of packages sold. Number of prescriptions. Number of dosages (or the number of tablets, litres of infusion solutions etc.). Defined daily dose (DDD). Prescribed daily dosage (PDD). The percentage of the population using a drug. 10.3 Factors which determine the volume of a drug consumed in a country. 10.4 Factors found to be related to the volume of drug consumption. Time. The level of industrialization and income. Cultural and organizational factors. 10.5 Factors which influence drug consumption at the individual level. Skewed distribution. Morbidity factors. Age. Sex. Civil status. Income and level of education. Role of Media. Other factors. 10.6 Qualitative studies of drug consumption. 10.7 Summary of the chapter. References. 11. Marketing of drugs. 11.1 Historical background. The transfer of production of raw drug materials from pharmacies to the drug industry (in Europe from the mid-nineteenth century to about the 1880s). The selling of quasi-drug products outside the pharmacy system (in Europe from about 1880 to 1920). The transfer of ready-made drug production from pharmacies to the drug industry (in Europe from about 1920 to 1950). The introduction of new marketing activities (in Europe from about 1950 to 1980). Marketing of drugs from the 1980s. 11.2 The contextual factors which affect the diffusion of a drug. 11.3 The marketing goals of drug companies. 11.4 Factors determining what a drug company spends on the marketing of a new drug. The competitive situation. The age of the drug. The drug class. The expected effects of more commercial information. Rules of thumb. The size of the drug company. The company image. Historical factors, national culture and economy. 11.5 The relative effects of different media and messages in commercial drug information to prescribers. 11.6 Commercial media directed at the general public. 11.7 A national perspective on commercial drug information. 11.8 Summary of the chapter. References. 12. The market structure. 12.1 The international market structure. 12.2 The market structure in a specific country. 12.3 Summary of the chapter. References. 13. Drug control. 13.1 The definition of drug control. 13.2 A process model of the drug control system in a country. 13.3 The processes to ensure that each aspect of drug control complies with the necessary norms or standards. 13.4 The control measures. 13.5 Clinical trials. 13.6 Summary of the chapter. References. 14. Drug prescribing. 14.1 Normative studies. 14.2 Sociological studies. 14.3 Information process studies of drug prescribing. 14.4 Prescription studies based on a cognitive perspective. The non-habitual prescribing process. Therapeutic effect. Low incidence of side effects. Low drug costs. Patient convenience. Taste, smell and appearance of the drug. Documentation. The preparations available in the most frequently used dosage forms and strengths. The country of origin. The prescriber's company preferences. Drug availability. 14.5 How standard selections change. 14.6 Making a diagnosis. 14.7 Placebo prescribing. 14.8 Summary of the chapter. References. 15. Patients' attitudes and behaviour. 15.1 Background. 15.2 Explanatory models. 15.3 A process model: how a layperson deals with medical symptoms. Detection of symptoms. Symptom judgement stage. The stage of selecting courses of action. Treatment with traditional medicine and herbal medicines. 15.4 OTC drugs. 15.5 Patient compliance. How to measure compliance. A cognitive model of the factors which determine the degree of compliance. How to improve compliance. 15.6 Summary of the chapter. References. 16. Drug information. 16.1 Background. 16.2 The role of mass media. 16.3 The drug information sources used. Research methods. Information about prescription drugs. Information about non-prescription drugs. 16.4 Drug information from a sender's perspective. The receiver's satisfaction with the information. Message understanding. Proper use of the product. Emotional support. Attitudinal changes. Changes in knowledge. Behavioural changes. Health effects. Reduction in adverse drug effects. Satisfactory information costs. 16.5 Mass media campaigns. 16.6 The value problem. 16.7 Summary of the chapter. References.