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In this last article in the series the authors focus on the issue of researching and evaluating pharmaceutical policy. The past five articles made an argument for why pharmaceutical policy is important and why it is different from health policy. The evidence base needed for pharmaceutical policymaking is also somewhat specialized in relation to health policy. Taking these differences into consideration the authors provide their definition of pharmaceutical policy. The knowledge base for good pharmaceutical policymaking needs to be broad and include approaches and methodologies ranging from the highly quantitative and experimental to the purely qualitative. Other policy questions such as those concerned with rational use of medicines and economics illustrate that pharmaceutical policy needs more varied approaches than randomized clinical trials alone can provide. The importance of gaining a thorough overview and understanding of the available design and methodological options for policy analysis is emphasized. Research into pharmaceutical policy has many commonalities with evaluation and policy analysis. Some of the main pitfalls that policymakers, researchers and analysts can fall into when formulating and evaluating pharmaceutical policy are discussed and include: using too narrow evaluation questions; choosing inappropriate methods/designs; and the problem of bias and self-censorship. The authors conclude this series by advocating a strong focus on research and an international evaluation culture around pharmaceutical policy. They emphasize the importance of pharmaceutical specialists' (i.e., pharmacists') involvement in pharmaceutical policy analysis and the policy consultative process.

In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy as a health care profession, as well as what it means when we view pharmaceutical policy in the context of the health sector labour market, is discussed. The authors also discuss how factors external to the profession are affecting its purpose and realm of practice, including the current trend in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental in developing new and expanding roles for the profession, sometimes inspired by external events, but often as a result of their own prerogative. The pharmacy profession is encouraged to take a leading role in forming and contributing to policy, in this way making visible its contribution to society in general and public health in particular. If not, the profession will forever be reacting to policy and will remain at the mercy of policymakers and other strong actors in society.

Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry. The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation; patients and professionals have different rationalities with regard to their views on medicine. Because the lay public and medicine users are not one entity, one of the many challenges facing policy makers today is to identify, incorporate and prioritise the many diverse needs. The authors recommend research which includes studies that look at: lay attitudes towards pharmaceutical policy; lay experiences of drug therapy and how it affects their daily lives; the problem of identifying lay representatives; the relationship between industry and the consumers; the effect of the media on medicine users and on pharmaceutical policy itself. The authors acknowledge that although lay involvement in policy is still in its infancy, some patient organisations have been successful and there are developments towards increased lay involvement in pharmaceutical policymaking.

In this article the authors provide insight into the basis for price setting of medicines, the increasing pharmaceutical budgets in the past decades, and the measures governments and insures have taken to curb rising pharmaceutical costs. Four reasons are out lined for the fact that medicines are by some considered expensivey: 1) there are fundamental differences between medicines and other consumer products; 2) medicines are technology requiring an inordinate amount of research and development; 3) medicines are developed, manufactured, and distributed according to strict regulatory requirements; 4) medicines are most often selected by a physician for a specific patient and reimbursed in whole or in party by a third-party insurer or the state. Pharmaceuticals mean share of GDP has been 1.2% in OECD countries in recent decades. Pharmaceuticals accounted for 15.4% of total health expenditure, with public spending about half of this amount. Since 1970, the average share of GDP for pharmaceuticals in most countries has increased 1.5% more per year than GDP growth. Four types of strategies to curb rising Pharmaceuticals costs are described and a taxonomy of strategies provided These are:1)price and profit controls; 2) reimbursement system charges; 3) other fiscal measures; 4) quality measures. Pharmaceuticals policy has suffered from the pervasive misunderstanding that drugs are like any other commodity; resulting in policy makers viewing pharmaceuticals expenditures without thinking about drugs in their proper content of health care. The authors conclude by advocating a balanced approach to policymaking in a environment of rising pharmaceuticals costs.

In this article the authors deal with issues of drug utilisation from a clinical and policy perspective. They address the difficulties of managing drug therapy on a population level, which is known among professionals, as the problem of rational use of medicines. Various definitions and interpretations are presented and compared. This is followed by a presentation of the concerns associated with pharmaceutical marketing from a policy perspective, including the fear that the dominance of information produced by industry may lead to irrational drug use. Next, the authors review the tools for policy making including educational, managerial, and regulatory interventions. The (often overlapping) concepts of medicines management, clinical pharmacy and pharmaceutical care are then discussed to show how professionals, sometimes in collaboration with policymakers, have tackled the problem of nonrational use of medicines. The authors address the question as to whether the rational use of medicines a universal concept, whether it can be and whether it should be? They argue that, as with most concepts, the rational use of medicines must always be viewed in context. They conclude that pharmacy needs to adapt its way of thinking to include the issue of context. They point out that clinical pharmacists today already adapt their decisons to each patient and patient group. Policy-makers are encouraged to adopt a similar approach because populations as well as particular market situations vary and therefore policy solutions cannot be considered universal.

Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

Background: This article presents the results of a study on quality of pharmacy services and perceived risk of pharmaceuticals. The results presented here are part of a multi-study evaluation of major changes in drug distribution in Iceland., Objectives: This sub-study addressed the question: what is the lay user perspective on pharmaceuticals and pharmacy services, including their perception of risk?, Methods: To answer this question, seven focus group discussions were conducted with pharmacy customers in different locations in Iceland following new drug distribution legislation in 1996., Results: The lay perspective emphasizes a definite split between lay and expert views on the value and quality of pharmaceuticals, drug therapy and pharmacy services, as well as in their assessment of risk. Participants voiced spontaneous criticism of the roles of both physicians and pharmacists in drug therapy; and expressed concern about the quality and safety of pharmaceuticals. Some scope for shared values was noted between the legislative goals and the lay user perspective, despite the fact that the public was in no way involved in the drafting of the new legislation., Conclusion: The results of this study raise questions about the nature and extent of the perceived gap between the medical and pharmacy professions on the one side and the lay public and health policy decision-makers on the other side in their views on the quality and safety of pharmaceuticals and pharmacy services.