Janine Marie Traulsen

Cost-Containment as Part of Pharmaceutical Policy

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.

Multimethod research into policy changes in the pharmacy sector—The Nordic case

This article aims to explain the nature of multimethod studies and to illustrate their role in pharmaceutical policy research. In the field of pharmaceutical policy research, methodological and theoretically sound evaluation is the main goal. Reflexive learning is required in order to address and resolve one of the important paradoxes of late modern societies, which is that while the increasing complexity of social systems progressively undermines notions of certainty in social knowledge, it simultaneously raises the stakes in relation to rational guidance of those systems. By reflecting over our own research processes, we identified the strengths and weaknesses of multimethod research. We present our research methods and the experiences of pharmaceutical policy changes from two separate evaluation studies, one from Iceland and the other from Denmark. In addition, examples from a third study in progress are included: a multimethod international comparison of recent changes in pharmaceutical policy in Iceland, Denmark and Norway. Based on our experiences and reflections, we identified four of the most important issues we encountered in carrying them out: The importance of doing research in context; Challenges of comparison and questions of compatibility of data--both qualitative and quantitative; The importance of doing these studies with a multidisciplinary team; Research in pharmaceutical policy is a fluid, ongoing process.

Opportunities and challenges in social pharmacy and pharmacy practice research.

Pharmacy practice and social pharmacy are two important research areas within pharmaceutical and health sciences. As the disciplines have undergone and are still undergoing changes, it is useful to reflect on the current state of their research as the basis for discussing further development. The two areas are currently beset by a lack of consensus and charged all too often with evaluating narrowly focused pharmacy services. With the added challenge of diminished funding for research and the pressures to publish results, these fields have to accommodate a much broader research framework than ever before. In this article, the challenges and opportunities in current research are reviewed, and suggestions provided on how to further research in these areas. A systematic content analysis is important to benchmark trends in the types of studies conducted, and to map the collaboration and funding within these areas.

Going to the doctor with enhancement in mind – An ethnographic study of university students’ use of prescription stimulants and their moral ambivalence

Abstract Aims: With this article, we aim to use students’ moral ambivalence towards prescription stimulants and the doctor’s who prescribe them to problematize the distinction between enhancement and treatment. We do this by investigating a case in which students obtain legitimate prescriptions for (covert) enhancement purposes. Methods: The study is based on ethnographic fieldwork and in-depth interviews with 20 university students from multiple universities in New York City, from which the case is drawn. Findings: Three main themes were identified in the analysis. “The doctor prescribed them” illustrates how these students use doctors as easy access to study drugs, and legitimize their use of stimulants because they were prescribed. The second theme, “A good cause”, shows that the purpose is what counts as a measure for whether stimulant use is considered morally acceptable or not. The third theme, “Being responsible” refers to how they regard themselves as responsible stimulant users, particularly when not following the doctor’s directions. Conclusions: Through an ethnographic approach, we gain a more nuanced understanding of non-medical stimulant use that takes into account the context in which it occurs. We suggest that students’ moral ambivalence reflects the increasingly blurred boundaries between what is considered treatment and enhancement in contemporary society.

'I'm Happy if I Can Help'. Public views on future medicines and gene-based therapy in Iceland

Objective: To explore lay perceptions about medicine and drug therapy (including gene-based therapy) in the present and in the future. Background: Following almost a year of national debate, the Icelandic parliament passed the Health Sector Database (HSD) Act in 1998. No single issue has been as much debated in Iceland as this database. Despite the explosion of popular and scientific literature in the field of bioethics, there is still a paucity of research concerning ‘lay’ contributions to the debates. Methods: The study was designed as a qualitative study. Focus groups (FGs) were conducted followed by one-on-one interviews with the FG moderator. Participants were asked to comment on a future scenario consisting of predictions concerning the consequence of the Human Genome Project over the next 40 years. Participants: Forty-two persons participated in eight FGs in Iceland. The Icelandic moderator was interviewed in English after each group. Conclusions: The lay public was relatively optimistic with regard to the future of drugs and gene-based therapy. Reasons for this optimism can be found in a basic trust and belief in the welfare state and the health system. These results are not consistent with studies carried out in other countries where the public appears to be focused on the negative effects of genetic research and the threats to privacy. Most participants expressed concern about potential problems with regard to social and equity issues, whereas the HSD controversy, a discourse based on the rhetoric of bioethics, was at variance with the issues focused on by the lay public.

Qualitative Methods in Pharmacy Practice Research

Qualitative research within pharmacy practice is concerned with understanding the behavior and underlying motives, perceptions, and ideas of actors such as pharmacy staff, pharmacy owners, patients, other health care professionals, and politicians to explore various types of existing practices and beliefs in order to improve them. As qualitative research attempts to answer the “why” questions, it is useful for describing, in rich detail, complex phenomena that are situated and embedded in local contexts. Typical methods include interviews, observation, documentary analysis, netnography, and visual methods. Qualitative research has to live up to a set of quality criteria of research conduct in order to provide trustworthy results that contribute to the further development of the area.

Risk-sharing agreements in the EU: A systematic review of major trends

ObjectiveOur objectives were to explore the changes in the level of interest in risk-sharing agreements (RSAs) in the EU during the last 15xa0years and the underlying reasons for these changes.MethodsA systematic literature review was conducted using PubMed, Scopus, Web of Science, and Embase. Articles identified were divided into ‘quantitative articles’ used to establish the level of interest and ‘qualitative articles’ used to identify the underlying trends in RSAs.ResultsThe literature search retrieved 2144 scientific articles. Data were extracted from 238 articles. Of these, 100 contained quantitative data and 138 contained qualitative data. The pace of articles being published about RSAs grew significantly in 2015, which related to the increase in interest in and knowledge about RSAs. The underlying reasons for the fluctuations were condensed into four overall themes: (1) push for value-based pricing, (2) economic crisis and further push to contain costs, (3) criticism of RSAs in the real world, and (4) diversification of RSAs to fit the purpose.ConclusionThe overall level of interest in RSAs in the EU has been increasing since 2000; therefore, articles reporting the number of RSAs implemented and case studies have been steadily growing as evidence is becoming more readily available. The number of qualitative articles reporting and discussing the underlying reasons for these changes in interest has largely fluctuated over the last 15xa0years. Despite these fluctuations, interest in RSAs remains high.

Falsified Medicines—Bridging the Gap between Business and Public Health

The pharmaceutical industry is one of the most regulated industries in the world. While legislation is necessary to protect patients, too much legislation is said to hamper innovation and increase medicine prices. Using qualitative methods such as interviews and document analysis, we investigated the role of private stakeholders in the EU policymakers’ decision to initiate legislation to combat falsified medicines in 2008. Our results show that the pharmaceutical industry, brand owners in particular, were strong proponents of legislation to combat falsified medicines. Their support was not fueled by fear that falsified medicines would harm patients or their own business, but rather because legislative action in this area would advance policies that benefit their businesses objectives. The brand owners framed the issue to policymakers as best to support their business objectives. In general, supply chain actors lobbied for stricter requirements in order to challenge competitors. In the end, the Falsified Medicines Directive may have suffered from company influence not by addressing the primary problem of falsified medicines, but rather by creating additional legislation that benefits the supply chain actors.

Fighting falsified medicines with paperwork – a historic review of Danish legislation governing distribution of medicines

BackgroundMany areas of pharmaceutical legislation in the European Union (EU) are harmonised in order to promote the internal market and protect public health. Ideally, harmonisation leads to less fragmented regulation and cross-border complexities. This study, however, focuses on an increasingly harmonised legislative area that is subject to increases in requirements and complexities: the distribution of medicines. This study compared Danish legislation governing the distribution of medicines before and after Denmark joined the EU in order to assess the impact of EU harmonisation, as well as to evaluate whether the drastic increases in requirements mandated by the Falsified Medicines Directive of 2011 correspond to a new approach to governing the pharmaceutical supply chain.MethodsA review was conducted of 115 applicable Danish laws, executive orders and guidelines from 1913 to 2014. Legal requirements were organised according to the year they were published and the companies they affected. Greater changes in legislative requirements were developed through inductive content analysis.ResultsEarly legislation positioned pharmacies as gatekeepers, requiring them to identify and stop medicines of substandard quality. Legislation to regulate the supply chain was slow to materialise. After Denmark joined the EU, the scope of legislation widened to include all actors in the supply chain, and the quantity of legislation increased dramatically. Simultaneously, requirements became more specific, thereby promoting a formalistic interpretation and focusing the attention of companies and authorities on predefined areas with little room to implement innovative solutions. Over time, documentation became the focus of legislation, requiring companies to provide documentary evidence for their compliance with legislation. The Falsified Medicines Directive continues these trends by increasing requirements for documentation and promoting a formalistic interpretation.ConclusionThe legislative approach adopted since Denmark joined the EU gives companies and medicine inspectors little room to interpret legislation. The Falsified Medicines Directive does not depart from this approach. Legislation seems more focused on enforcing similar requirements than on benefiting public health. Legislation may benefit from allowing room for local interpretation of requirements.

Human resource development in supply chain management- what do the UN agencies say?

Background Efficient and well trained health workers are required for successful functioning of a supply chain that ensures equitable access to health commodities and universal coverage. Various UN organizations have identified this need as referenced to in a variety of online UN resources. This research aims to collect and analyse this extensive literature systematically and provide evidence for core strengthening parameters of human resources.