Regulatory Capture in Pharmaceutical Policy Making: The Case of National Medicine Agencies Related to the EU Falsified Medicines Directive.

BACKGROUND: Regulatory capture describes the phenomenon in which regulators (e.g. medical agencies) protect the interest of the companies they regulate rather than the interest of the public. Not much is known about the mechanisms of this potential threat within the area of pharmaceutical regulation. OBJECTIVES: Through a comparison of two EU member states, the Netherlands and Denmark, this study aimed to investigate how regulatory capture could exist in pharmaceutical regulation. The EU Falsified Medicines Directive was used as the case, as it provided an opportunity for national medicine agencies to interact with various stakeholders. METHODS: The processes of negotiation and implementation of the directive were mapped by interviewing 23 stakeholder representatives and triangulated with relevant documents. A meaning condensation method was applied to show how stakeholders were involved with authorities, and the theory of regulatory capture was used to interpret how the two countries were susceptible to capture. RESULTS: The Danish Medical Agency was central in all relevant processes, whereas in the Netherlands, the Ministry of Health initiated the processes during the negotiation phase and, subsequently, three medical agencies shared responsibilities in the implementation phase. During the negotiation phase, the Dutch process was more focused on consensus among stakeholders while the Danish process focused on preparing the subsequent implementation. Neither member state prioritised transparency during implementation, but rather focused on timely implementation. CONCLUSIONS: The processes of EU negotiations and implementation of the Falsified Medicines Directive were handled quite differently in Denmark and the Netherlands. It is possible that regulatory capture could be prevalent in both member states as policy makers were only in limited dialogue with patients. EU countries must decide whether this technocratic approach is acceptable, or whether they should make a more concerted effort to include the public.

Mandatory medication content in the curricula of six health care personnel types with patient contact in Denmark.

Medication use is a complex process involving different types of health care personnel. This study investigated and compared mandatory medication content in the curricula of six types of health care personnel with patient contact. Using content analysis, three independent raters analysed the mandatory medication content for physicians, pharmacists, pharmaconomists, nurses, health care assistants and support workers in the Capital Region of Denmark. Three dimensions were analysed as follows: communication with patients about medication, medication use or pharmacology and medication formulation and production. ECTS credits were totalled for courses analysed to have high or medium content, and inter-rater reliability was tested with Fleiss' kappa. The total mandatory medication content for pharmacists was 197.0 ECTS, physicians 136.0 ECTS, pharmaconomists 123.3 ECTS, nurses 52.0 ECTS, health care assistants 17.8 ECTS and support workers 0.0 ECTS. Communication with patients about medication was included to the greatest extent in the educations of pharmaconomists (112.0 ECTS), pharmacists (37.5 ECTS) and physicians (25.0 ECTS). Knowledge about medication use and pharmacology was taught primarily to pharmacists (146.5 ECTS), physicians (123.6 ECTS) and pharmaconomists (89.8 ECTS) and to a lesser extent nurses (52.0 ECTS), health care assistants (17.8 ECTS) and support workers (0.0 ECTS). Medication formulation and production were taught only to pharmacists (93.0 ECTS) and pharmaconomists (25.1 ECTS). Mapping the basic competencies about medication taught to each of the six health care personnel types can lead to a better understanding of how they can complement each other in patient care. The study points to weaknesses in medication curriculum content for health care personnel with the most patient contact.

Risk-Sharing Agreements in the EU: A Systematic Review of Major Trends.

OBJECTIVE: Our objectives were to explore the changes in the level of interest in risk-sharing agreements (RSAs) in the EU during the last 15 years and the underlying reasons for these changes. METHODS: A 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. RESULTS: The 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. CONCLUSION: The 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 15 years. Despite these fluctuations, interest in RSAs remains high.

Shifting perspectives - Planning for the future of the pharmacy profession taking current labor market trends into consideration.

The future of the pharmacy profession and concerns about professional identity have been popular and recurring themes in professional journals and at international pharmacy conferences for more than 30 years. The aim of this paper is to contribute to realistic and viable visions for the future of the pharmacy profession via insights through labor market and work organization theories. These insights provide an understanding of contemporary work patterns and what they mean for the future role of community pharmacists. It appears that an important and influential contemporary trend in work organization today is precarious work, i.e. non-standard employment that promotes and relies on a flexible and fluid work force. Contrary to permanent employment, precarious work is often poorly paid, insecure, unprotected, and in many cases cannot support a household. The growth of precarious work among professionals, including pharmacists has been documented in many countries. In the early 21st century a major concern in the UK was the growth in the number of pharmacists who choose to be self-employed "locums" as opposed to seeking permanent employment. With the spread of precarious work a new, involuntary form of employment appeared a decade later with the spread of "zero-hour contracts" and "exclusivity agreements". Particularly affected by these flexible, precarious work conditions are the highly-educated young health professionals such as pharmacists. The profession needs to be proactive in order to stay abreast of economic/workforce and organizational trends. The way forward is a commitment to a dynamic, knowledge-based vision that includes an ongoing analysis of the outside world. The core role of pharmacists in the future includes: 1. engagement in interprofessional education with other healthcare professionals; 2. an acceptance of the contribution that lay knowledge provides to the understanding of health and medicines, and 3.keeping ajour with new and revolutionary treatments, both pharmaceutical and non-pharmacological.

Pharmacy Interns' Perception of Their Professional Role.

Objective. To determine pharmacy interns' perceptions of the roles of the pharmacist and pharmacy prior to and during the pharmacy internship and to compare their perceptions with those of their supervisors and the pharmacy customers. Methods. Questionnaires were completed and submitted by 395 interns prior to and during their internships. Interns interviewed their supervisors and two to four local customers. Results. Ninety-six supervisors and 285 customers were interviewed. Interns' perceptions were aligned with those of their supervisors in that both groups indicated that a pharmacist's most important role is that of a clinical leader. Furthermore, interns' perception of customers' expectations regarding the pharmacy were well aligned with customers' actual expectations with regard to service. Conclusion. The study illustrates that interns became more aligned in their perceptions due to the pharmacy internship. The study findings imply that the pharmacy internship influences interns' perception of the pharmacy and pharmacist's roles in society through complex individual and social learning processes.

Drawing on healthcare professionals' ethnicity: lessons learned from a Danish community pharmacy intervention for ethnic minorities.

AIMS: To present and discuss implementation experiences regarding the involvement of community pharmacists with ethnic minority backgrounds in a medication review intervention for ethnic minority poly-pharmacy patients in Denmark. METHODS: Data sources include 1) reflection notes from an introductory seminar with pharmacists and the cross-disciplinary research team and 2) five individual interviews and one focus group interview with pharmacists. Data were thematically coded and synthesised to identify underlying rationales and challenges encountered when involving professionals with ethnic minority backgrounds in interventions for ethnic minorities. RESULTS: Informants perceived the need for interventions targeted at ethnic minority poly-pharmacy patients, and highlighted the potential of involving professionals with diverse ethnic backgrounds in such interventions. However, implementation created challenges, because the professional identity of the pharmacists reduced their options for serving as peers with the same ethnic background. Furthermore, issues related to organisational difficulties and overcoming language barriers in the intervention impacted on the potential of involving professionals with ethnic minority backgrounds. CONCLUSIONS: Involving healthcare professionals with ethnic minority backgrounds in encounters with ethnic minorities holds potential for the adaptation of services to ethnically diverse populations, thus improving access to and quality of care. However, it is important to ensure sufficient personal and organisational support and to acknowledge the delicate balance between simultaneously serving as a peer and as a professional.

Are we ready to accept the challenge? Addressing the shortcomings of contemporary qualitative health research.

BACKGROUND: Qualitative approaches represent an important contributor to health care research. However, several researchers argue that contemporary qualitative research does not live up to its full potential. By presenting a snapshot of contemporary qualitative research in the field of social and administrative pharmacy, this study challenges contributors to the field by asking: Are we ready to accept the challenge and take qualitative research one step further? PURPOSE: The purpose of this study was to initiate a constructive dialogue on the need for increased transparency in qualitative data analysis, including explicitly reflecting upon theoretical perspectives affecting the research process. METHODS: Content analysis was used to evaluate levels of theoretical visibility and analysis transparency in selected qualitative research articles published in Research in Social and Administrative Pharmacy between January 2014 and January 2015. MAIN FINDINGS: In 14 out of 21 assessed papers, the use of theory was found to be Seemingly Absent (lowest level of theory use), and the data analyses did not include any interpretive endeavors. Only two papers consistently applied theory throughout the entire study and clearly took the data analyses from a descriptive to an interpretive level. It was found that the aim of the majority of assessed papers was to change or modify a given practice, which however, resulted in a lack of both theoretical underpinnings and analysis transparency. CONCLUSION: This study takes the standpoint that theory and high-quality analysis go hand-in-hand. Based on the content analysis, articles that were deemed to be high in quality were explicit about the theoretical framework of their study and transparent in how they analyzed their data. It was found that theory contributed to the transparency of how the data were analyzed and interpreted. Two ways of improving contemporary qualitative research in the field of social and administrative pharmacy are discussed: engaging with social theory and establishing close collaboration with social scientists.

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

BACKGROUND: Many 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. METHODS: A 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. RESULTS: Early 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. CONCLUSION: The 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.

Developing and sustaining human resources in the health supply chain in Ethiopia: barriers and enablers.

INTRODUCTION: The health supply chain is often the weakest link in achieving the health-related Millennium Development Goals and universal health coverage, requiring trained professionals who are often unavailable. In Ethiopia there have been recent developments in the area of health supply chain management. The aim of this study was to explore the current status of the development of human resources in health supply chain management in Ethiopia and to identify important factors affecting this development. METHODS: A series of face-to-face interviews with key stakeholders was carried out in 2014. The interviews were conducted using a semi-structured interview guide. The interview guide comprised 51 questions. A qualitative analysis of transcripts was made. RESULTS: A total of 25 interviews were conducted. Three themes were identified: General changes: recognition, commitment and resources, Education and training, and Barriers and enablers. Results confirm the development of human resources in health supply chain management in many areas. However, several problems were identified including lack of coordination, partly due to the large number of stakeholders; reported high staff mobility; and a lack of overall strategy regarding the job/career structures necessary for maintaining human resources. Rural areas have a particular set of problems, including in transportation of goods and personnel, attracting and keeping personnel, and in communication and access to information. CONCLUSIONS: Ethiopia is on the way to developing a nationwide viable system for health supply chain management. However, there are still challenges. Short-term challenges include the importance of highlighting strategies and programs for human resources in health supply chain management. In the long term, commitments to financial support must be obtained. A strategy is needed for the further development and sustainability of human resources in the health supply chain in Ethiopia.

Experiences from a pilot study on how to conduct a qualitative multi-country research project regarding use of antibiotics in Southeast Europe.

BACKGROUND: In 2014, a qualitative multi-country research project was launched to study the reasons behind the high use of antibiotics in regions of Southeast Europe by using previously untrained national interviewers (who were engaged in other antibiotic microbial resistance-related investigations) to conduct qualitative interviews with local patients, physicians and pharmacists. Little knowledge exists about how to implement qualitative multi-country research collaborations involving previously untrained local data collectors. The aim of this paper was therefore to contribute to the knowledge regarding how to conduct these types of research projects by evaluating a pilot study of the project. METHODS: Local data collectors conducted the study according to a developed protocol and evaluated the study with the responsible researcher-team from University of Copenhagen. The pilot study focused on 'local ownership', 'research quality' and 'feasibility' with regard to successful implementation and evaluation. The evaluation was achieved by interpreting 'Skype' and 'face to face' meetings and email correspondence by applying 'critical common sense'. RESULTS: Local data collectors achieved a sense of joint ownership. Overall, the protocol worked well. Several minor challenges pertaining to research quality and feasibility were identified, in particular obtaining narratives when conducting interviews and recruiting patients for the study. Furthermore, local data collectors found it difficult to allocate sufficient time to the project. Solutions were discussed and added to the protocol. CONCLUSIONS: Despite the challenges, it was possible to achieve an acceptable scientific level of research when conducting qualitative multi-country research collaboration under the given circumstances. Specific recommendations to achieve this are provided by the authors.

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.

Pursuing Pleasures of Productivity: University Students' Use of Prescription Stimulants for Enhancement and the Moral Uncertainty of Making Work Fun.

This article presents ethnographic data on the use of prescription stimulants for enhancement purposes by university students in New York City. The study shows that students find stimulants a helpful tool in preventing procrastination, particularly in relation to feeling disinterested, overloaded, or insecure. Using stimulants, students seek pleasure in the study situation, for example, to get rid of unpleasant states of mind or intensify an already existing excitement. The article illustrates the notion that enhancement strategies do not only concern productivity in the quantitative sense of bettering results, performances, and opportunities. Students also measure their own success in terms of the qualitative experience of working hard. The article further argues that taking an ethnographic approach facilitates the study of norms in the making, as students experience moral uncertainty-not because they improve study skills and results-but because they enhance the study experience, making work fun. The article thereby seeks to nuance simplistic neoliberal ideas of personhood.

A culturally competent education program to increase understanding about medicines among ethnic minorities.

BACKGROUND: It has been previously suggested that the risk of medicine-related problems-i.e., negative clinical outcomes, adverse drug reactions or adverse drug events resulting from the use (or lack of use) of medicines, and human error including that caused by healthcare personnel-is higher among specific ethnic minority groups compared to the majority population. OBJECTIVE: The focus of this study was on reducing medicine-related problems among Arabic-speaking ethnic minorities living in Denmark. The aim was twofold: (1) to explore the perceptions, barriers and needs of Arabic-speaking ethnic minorities regarding medicine use, and (2) to use an education program to enhance the knowledge and competencies of the ethnic minorities about the appropriate use of medicines. SETTINGS: Healthcare in Denmark is a tax-financed public service that provides free access to hospitals and general practitioners. In contrast to the USA or the UK, serving ethnically diverse populations is still a relatively new phenomenon for the Danish healthcare system. Ethnic minorities with a non-Western background comprised a total of 6.9 % of the Danish population. METHODS: Data were collected through qualitative research. Four focus group interviews were conducted before and four after the education program. Thirty Arabic-speaking participants were recruited from language and job centers in Copenhagen. Participants received teaching sessions in Arabic on appropriate medicine use. The education program was evaluated by two methods: a written quiz for knowledge evaluation and focus group interviews for process evaluation. It took place during the first semenester of 2012. Results The majority of the participants were dissatisfied with the knowledge about medicines inherited from their parents. They also expressed their frustrations due to communication problems with Danish doctors. According to the impressions and quiz results of participants, the program was relevant, rich in information and effective. The program helped bridge the gap between participants and doctors. The commonality of the culture, language and gender shared by the researcher pharmacist and participants enhanced the success of the program. CONCLUSION: The education program may potentially reduce medicine-related problems by providing participants with knowledge and competencies about appropriate medicine use. We recommend implementing education programs for ethnic minorities using the cultural competence approach to the appropriate use of medicines. Ideally, programs should be implemented in places that are frequented by ethnic minorities, and taught by health professionals with the same ethnic background as participants.

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.

Customer interest in and experience with various types of pharmacy counselling - a qualitative study.

BACKGROUND: Despite pharmacists' extensive knowledge in the optimization of patients' medical treatments, community pharmacies are still fighting to earn patients' trust with respect to medicinal counselling at the counter. OBJECTIVE: The aim was to investigate how patients perceive pharmacy counselling at the present time, in order to develop the patient-pharmacy relationship for the benefit of both patients and pharmacies. DESIGN: Short semi-structured interviews were carried out with pharmacy customers by pharmacy internship students. SETTING AND PARTICIPANTS: One hundred and eight customers in 35 independent pharmacies across Denmark were interviewed during the spring of 2011. MAIN VARIABLES STUDIED: Customers were interviewed about their expectations of pharmacies in general and their experiences with medical counselling in particular. RESULTS: Customers perceive community pharmacies very differently in terms of both expectations of and positive experiences with counselling. They appear to be in favour of pharmacy counselling with respect to over-the-counter medicine and first-time prescription medicine in contrast to refills. Customers find it difficult to express the health-care role of pharmacies even when experiencing and appreciating it. DISCUSSION: Lack of appreciation of pharmacy counselling for refill prescription medicine and the difficulty in defining the role of pharmacies might stem from the difficulties that customers have in understanding medicine and thus the role of counselling services with respect to medicine. The pharmacy staff does not seem to realize these barriers. CONCLUSIONS: For pharmacies to encourage customer interest in pharmacy counselling, the staff should start taking the identified barriers into account when planning communication strategies.

Encounters with immigrant customers: perspectives of Danish community pharmacy staff on challenges and solutions.

OBJECTIVES: To explore the challenges that Danish community pharmacy staff encounter when serving non-Western immigrant customers. Special attention was paid to similarities and differences between the perceptions of pharmacists and pharmacy assistants. METHODS: A questionnaire was distributed to one pharmacist and one pharmacy assistant employed at each of the 55 community pharmacies located in the five local councils in Denmark with the highest number of immigrant inhabitants. KEY FINDINGS: The total response rate was 76% (84/110). Most respondents found that the needs of immigrant customers were not sufficiently assessed at the counter (n = 55, 65%), and that their latest encounter with an immigrant customer was less satisfactory than a similar encounter with an ethnic Danish customer (n = 48, 57%) (significantly more pharmacists than assistants: odds ratio, OR, 3.19; 95% confidence interval, CI, 1.27-8.04). Forty-two per cent (n = 35) perceived that immigrant customers put pressure on pharmacy staff resources, while 27% (n = 23) found that the immigrant customer group make work more interesting. More pharmacists than assistants agreed on the latter (OR, 3.43; 95% CI, 1.04-11.33). Within the past 14 days, 86% (n = 72) experienced that their advice and counselling were not understood by immigrant customers, whereas 49% (n = 41) experienced lack of understanding by ethnic Danes; and 30% (n = 25) had consciously refrained from counselling an immigrant, whereas 19% (n = 16) had done so with an ethnic Dane. Use of under-aged children as interpreters during the past month was reported by 79% of respondents. Regarding suggestions on how to improve encounters with immigrant customers, most respondents listed interventions aimed at patients, general practitioners and pharmaceutical companies. CONCLUSIONS: Community pharmacy staff report poorer quality in their encounters with immigrant customers, including sub-optimal counselling and frequent use of under-aged children as interpreters. Our study also reveals certain differences across personnel groups, which may be explained by differences in level of education.

Challenges to counseling customers at the pharmacy counter--why do they exist?

Challenges to engage pharmacy customers in medicine dialogues at the counter have been identified comprising a new and extended clinical role for pharmacists in the health care system. This article seeks to expand understanding of factors involved in successful interaction at the pharmacy counter between customers and pharmacy staff to develop their relationship further. Practical challenges to customer encounters experienced by community pharmacists are discussed using theory from the field of mainly inter-relational communication and particular studies on pharmacy communication. Preconceived expectation of customers, the type of question asked by pharmacy staff, and differences in perception of illness and medicines between staff and customers are discussed. Both staff and customer influence the outcome of attempts by pharmacy staff to engage customers in dialogue about their medicine use through a complex mechanism of interaction. It is recommended that practitioners and researchers begin to distinguish, both theoretically and practically, between the content of a conversation and the underlying relationship when exploring and further developing the therapeutic relationship between pharmacy personnel and customers.