New Trends in European Pharmacy

Publication Date January 2001
ISBN 1859784798
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This report analyses the development of pharmacy systems in Europe; in the 15 member states of the European Union (EU), the EU-applicant countries of central and eastern Europe and some others.

This report analyses the development of pharmacy systems in Europe; in the 15 member states of the European Union (EU), the EU-applicant countries of central and eastern Europe and some others.

The pharmacist of 50 years ago was held in some awe by members of the public. They took the medicines they were dispensed knowing nothing of what they contained. In the twenty-first century this is a thing of the past. People have a good understanding of their illness. They have a greater understanding of pharmacists and respect them as health professionals. However, they do not yet appreciate the much greater influence that will come to pharmacists in the next 10 years.
Contents

Executive Summary

Chapter 1: The Development of Pharmacy in Europe

Origins of pharmacy
History
Mediaeval history
The apothecary and the physician
Twentieth century trends
Development of national health services and health insurance schemes
Evolution of drug companies
Massive evolution of science and technology
Healthcare reorganisation
New specialisations for the pharmacist
Standards and regulation
Changing roles of doctor and pharmacist
Empowerment of patients
Empowerment of pharmacists

Chapter 2: The Role and Function of Pharmacy and The Pharmacist

Procurement, storage, handling, distribution and disposal of medicines
Wholesale supply
Parallel imports
Pharmacist prescribing
Advice to patients
Use of medicines
Choice of OTC medicines
Health promotion
Medical advice lines
Advice to other healthcare professionals
Part of an integrated team
Influence on prescribing and dispensing
Compounding and dispensing of medicines
Compounding
Generic prescribing, generic substitution and therapeutic substitution
OTC substitution
Conclusion

Chapter 3: Pharmacy and Changing Health-Care Priorities

European healthcare - rising to many challenges
Many reasons for change
Increasing age of the population
Decreasing size of the working population
Increasing incidence of infectious diseases and of chronic medical conditions
World economic situation
Better informed patients
New medical technologies
New medicines and regulatory requirements
National healthcare systems and their economic health
Government- or state-appointed health insurance
National health services based on taxation
Cooperative systems
EU applicants, first round
EU applicants, second round
Other countries
Healthcare reforms conclusion - many reasons; similar outcomes
Cost containment
Medicines as a part of healthcare spending
The pharmacist's position
Many factors; limited influence
The pharmacist and generics
The pharmacist and OTCs
The growing importance of payers
Efficiency as well as cost saving
A more palatable exercise
Efficiency in pharmacy: medicines management
Changes in the pharmaceutical industry
A tiring giant
Problems for EU R&D
Generics and OTCs are gaining strength
Disease management and managed care

Chapter 4: New Mechanisms for Medicines Distribution

Distribution and wholesaling
Wholesaler-pharmacy chains
Boots
Alliance Unichem
Gehe
The pharmacy monopoly
Pharmacy specialisation
Advertising
Legislation
Industry advertising codes
Advertising the pharmacist
e-pharmacy
A cause for concern
WHO advice on buying medicines online - key points
Benefits of e-pharmacy
The EU gathers information
Views of the other sectors
Automation and electronic links
Mail order pharmacy

Chapter 5: Pharmacy's Industry and Professional Relations

Changing one affects all
Health professionals
Rivalry and territoriality, beginning to soften
Pharmacists' cooperation with doctors, selected countries, 2000
EU applicants
Others
Benefits of doctor-pharmacist cooperation
Pharmaceutical industry
Wholesalers
Consumers
Pharmacists' services for patients in selected countries
EU applicants
Others
Conclusion

Chapter 6: Pharmacy Economics

The economic value of pharmacy
Pharmaceutical sales and prices
Remuneration and profit margins
National pricing and pharmacist remuneration arrangements
EU member states
Other countries
The influence of generics and parallel imports on cost-saving
Pharmacoeconomics, outcomes research and health promotion
The bottom line

Chapter 7: The Influence of the EU

Actions on many levels
The EU, its institutions and law-making
EU legislation relating to medicines and other pharmacy products
Market authorisation
Classification
Labelling
Pharmacovigilance
Supplementary patent protection
Advertising
Wholesale distribution
Homeopathic medicines
Other specific types of medicines
European Pharmacopoeia
Medical devices
Cosmetics and animal testing
Employment and recognition of professional qualifications
Consolidating the legislation
The single market in pharmaceuticals
Key judgments of the ECJ
Centrafarm
Eurim-Pharm
Merck v. Primecrown
Judgments relating to repackaging
Decker and Kohll
Recent attempts to unify the market
Impact of the euro
e-commerce
The changing shape of Europe: Implications of enlargement of the EU
Public health initiatives
Research initiatives
In conclusion

Chapter 8: Hospital Pharmacy

A well-established place in the hospital system
Issues facing hospital pharmacy
Shortage of hospital pharmacists
Economic pressures
Organisational pressures
Role of pharmacists in relation to doctors and nurses
Role of pharmacy technicians
Medicines management
New technologies
Accountability, clinical governance and benchmarking
Professional recognition
Increased specialisation
Drug-related problems
The impact of change
New types of practitioners
Extending into the community
Lifelong learning

Chapter 9: The Changing Influence Of Academia

Pharmacy training
Historical background
The EU input
The WHO too
Changes in content of pharmacy training
Trends in pharmacy training
Popularity of pharmacy training
Women in pharmacy
Continuing professional development
Mobility and recognition of qualifications
Qualified pharmacists
Students
The influence of pharmacy schools and other professional bodies
Key pharmacy education networks
Research: challenges facing academic pharmacy
Conclusion

Chapter 10: Pharmacy into the Twenty-First Century

Trends and challenges
Pharmaceutical care
Clinical governance
Opportunities of science and technology
Genomics
Information and communication - the e-words
Balance in the workforce
Pharmacists and technicians
Doctors and nurses
Economics
Expensive new drugs
Distribution
Full-line versus short-line
Mail order and e-pharmacy
Pharmacy monopoly - a fading hope
Hospitals
New roles
Consumers
Information and empowerment
Patient benefit as much as cost savings
Where is pharmacy going?
How far will pharmacists take over advisory functions from doctors?
How far will pharmacists retain a supply function in view of e-pharmacy?
Will prescription medicines be restricted to medical
centres while pharmacies become retail outlets?
Conclusion

Appendix A: Good Pharmacy Practice

Guidelines adopted by the Pharmaceutical Group of the European Union, October 1996
1 Introduction
1.1 The underlying philosophy
1.2 Good pharmacy practice (GPP) requirements
1.3 The requirements in practice
1.4 Achieving GPP in practice
2 Guidelines
2.1 General guidelines on patient information
2.2 Facilities
2.3 General guidelines on the pharmacist and support personnel
2.4 Specific guidelines on supply and use of prescribed medicines and other healthcare products
2.5 Specific guidelines on encouraging rational prescribing and the correct use of medicines
2.6 Specific guidelines on self care
2.7 Specific guidelines on health promotion and ill- health prevention
References

Appendix B: Good Pharmacy Education Practice

Guidelines adopted by the International Pharmaceutical
Federation, August 2000
Background
Introduction
Recommendations
Conclusion
Annex

Appendix C: Good Distribution Practice (Gdp)
EU Guidelines on Good Distribution Practice of
Medicinal Products for Human Use
GDP-Guidelines
Introduction
Principle
Personnel
Documentation
Orders
Procedures
Records
Premises and equipment
Receipt
Storage
Deliveries to customers
Returns
Emergency plan and recalls
Counterfeit medicinal products
Special provisions concerning products classified as not for sale
Self-inspections
Provision of information to Member States in relation to wholesale activities

Appendix D: International, European and National Pharmacy and Pharmacy-Related Organisations
International organisations
European organisations
National organisations (member associations of PGEU)
National organisations (observer members of PGEU)
Glossary And Abbreviations
Bibliography
Order/Information Request Form

List of Tables

Table 2.1: Generic market share of total retail pharmaceutical market
Table 3.1: Overall health system performance of selected countries, 1997
Table 3.2: Public expenditure on health as % GDP
Table 3.3: Public expenditure on pharmaceutical goods as a % of public health expenditure
Table 3.4: Examples of pharmaceutical trade control mechanisms used in the EU
Table 3.5: National pharmaceutical markets, 1998 (ex-factory prices)
Table 3.6: Investment in pharmaceutical R&D, 1998
Table 4.1: Differing national status of pharmacy chains
Table 4.2: Uptake of electronic communications between wholesaler and pharmacy in selected countries, 1999
Table 6.1: Number of pharmaceutical companies operating in Europe and pharmaceutical production, 1998
Table 6.2: European market in community and hospital pharmacies and other outlets, 1998 (Euro m, at ex-factory prices)
Table 6.3: European medicines market per head of population (1998)
Table 6.4: Payment for medicines by compulsory health insurance systems and national health services (1998)
Table 6.5: European medicines market, 1998
Table 8.1: Sales of generic medicines, 1997
Table 9.1: National pharmacy qualifications and length of study
Table 9.2: Proportion of teaching time given to individual subject areas in the EU member states (1995)
Table 9.3: The Netherlands: number of pharmacists by gender, 1999
Table 9.4: Number of Apoteket employees by gender, Sweden 1999
Table 9.5: Research priorities reported by national pharmacy associations
Table 10.1: Numbers of pharmacies, pharmacists and support staff 1997-2000

List of Figures

Figure 2.1: Expenditure per capita on self-medication in EU member countries, 1996
Figure 2.2: Expenditure per capita on self-medication in selected countries 1993-96
Figure 3.1: Self-medication market as percentage of total pharmaceuticals market, 1998
Figure 4.1: Percentage of products distributed to public pharmacies
Figure 4.2: Sales of prescription products as percentage of total wholesaler turnover, 1997
Figure 5.1: The pharmacist combines two chains of flow
Figure 6.1: State spending on medicines per head, 1998
Figure 6.2: Average retail price of medicinal products, 2000
Figure 10.1: Population per pharmacy, selected countries, 1999