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.

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.

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.

The ambiguity of ethnicity as risk factor of vitamin D deficiency--a case study of Danish vitamin D policy documents.

OBJECTIVES: To explore how ethnic minorities at risk of vitamin D deficiency are constructed in Danish policy documents (current as of April 2009), regarding vitamin D supplementation. METHODS: Ten policy documents were analysed through content analysis, focusing on definitions and explanations of ethnic minorities being at risk of vitamin D deficiency. This formed the basis for an analysis of constructions of ethnic minorities at risk which was undertaken using the Social Construction of Technology (SCOT) theory as an organising framework. RESULTS: The analysis showed a high degree of interpretative flexibility regarding how ethnic minorities are constructed as a risk group for vitamin D deficiency. The ten documents analysed revealed eight different constructions of the ethnic minorities groups at risk. A low degree of interpretative flexibility was found regarding the importance of skin colour and skin covering. Major disagreements were found regarding the importance attributed to the Islamic religion, other traditions, immigration, gender and age, and use of an evolutionary explanation for the increased risk. CONCLUSIONS: Ethnic minorities at risk of vitamin D deficiency are constructed very differently in Danish policies current as of April 2009. A more precise definition of ethnic minorities in policies and research may be helpful in seeking to identify which ethnic minorities are and are not at risk of vitamin D deficiency.

The relationship between leadership style and provision of the first Danish publicly reimbursed cognitive pharmaceutical service--a qualitative multicase study.

BACKGROUND: Evidence suggests that leadership style is important to the sustainability of cognitive pharmaceutical services, yet only scarce literature on the relationship exists. OBJECTIVES: Support of the sustainability of the first publicly reimbursed cognitive service in Denmark, the Inhaler Technique Assessment Service (ITAS), was ascertained through a qualitative study to explore how leadership style shapes the implementation process of the service. Sustainability in this project was defined as the state where those asthma patients whose symptom status is negatively clinically affected (as defined by Global Initiative for Asthma guidelines) by inappropriate inhalation technique are identified and offered the service by pharmacy staff. METHODS: The study was an exploratory qualitative multicase study that used triangulation of both data sources and methods. A theoretical framework of Bolman and Deal inspired the analysis of how leadership style influenced the local process of implementation of the ITAS. Four pharmacies were selected for the analysis because they differed in terms of leadership actions in their implementation process and achievement of ITAS sustainability. The analysis was inductive and linked factors that influence ITAS provision as perceived by employees with the interpreted leadership style of the owner. RESULTS: Three main themes emerged: (1) the alignment of the owner and staff values, (2) whether owners perceived ITAS development as being under their own control, and (3) whether owners explicated the responsibilities of employees in the implementation process. The themes were interrelated. CONCLUSIONS: Pharmacy owner's leadership style was significant to sustainability of the ITAS. A strong wish by the owner to have ITAS implemented was important, followed by aligning the owner's values and visions with those of the employees. The widespread perception by owners that experienced users are not interested in the ITAS needs to be addressed to achieve sustainability.

Sustaining delivery of the first publicly reimbursed cognitive service in Denmark: a cross-case analysis.

OBJECTIVES: The aim was to identify local organisational factors that affect sustained delivery of the first Danish publicly reimbursed cognitive service, the Inhaler Technique Assessment Service (ITAS). The ITAS is a 10-min interactive counselling session during which pharmacy staff assess the inhalation technique of individual asthma patients at the pharmacy counter, and correct any errors. Knowledge of how the organisation of a local pharmacy influences ITAS provision will be used to develop quality indicators as part of a targeted quality-assurance system to support the sustainability of the service in all Danish community pharmacies. METHODS: Qualitative methods included field observations, semi-structured interviews, group interviews and the collecting of documentary material. Data-source and method triangulation were applied. Seven pharmacies were included in the study. A cross-case analysis compared pharmacies with sustained and reduced numbers of services based on three selected themes: administration of the ITAS, leadership interventions and professional values of pharmacy owner and staff. KEY FINDINGS: Pharmacies with sustained delivery had introduced systematic evaluations of the local delivery of the ITAS and made ongoing efforts to improve staff competencies. They dealt with individual barriers such as lack of knowledge of rarely distributed inhalation devices and communication techniques. Pharmacy staff in general rarely assessed patients' clinical needs before offering the service and rarely provided follow-up. Thus, pharmacy staff failed to utilise the full clinical potential of the ITAS. CONCLUSIONS: In order to achieve and support further ITAS sustainability, the knowledge, skills and professional values of pharmacy staff must be developed. Human resource leadership techniques would be useful in achieving this aim, as would focusing on the service by providing systematic evaluations.

Development of a qualitative exploratory case study research method to explore sustained delivery of cognitive services.

OBJECTIVE: To develop, apply and evaluate a new research method to establish relationships between structural and process elements of the provision of cognitive services. In-depth knowledge about how local organisational structural elements of community pharmacies shape the implementation process of cognitive services is needed to develop targeted quality assurance systems to ensure that the services are continuously provided to the patients who need them. The first publicly reimbursed cognitive service in Denmark, the Inhaler Technique Assessment Service (ITAS) is used as the case. SETTING: The research method was developed at the Faculty of Pharmaceutical Sciences at the University of Copenhagen and later applied to seven community pharmacies geographically spread around Denmark. METHODS: A pilot study as well as a subsequent literature review was conducted to determine which structure-process elements to focus on in the research method as well as to select appropriate theories and methods. RESULTS: The developed research method was a qualitative exploratory multi-case study, that was based on method triangulation of field observations, semi-structured interviews, group interviews as well as collection of documentary material. The three main themes of the research method were: the administration of tasks, leadership style and professional values. We integrated the organisational theories of Mintzberg, Bolman and Deal as well as Sørensen to support and clarify the data collection process and analyses. A cross-case analysis and an exploratory contextual analysis relating the leadership style of the pharmacy owner to the ITAS provision were applied to the collected data. CONCLUSION: The developed qualitative exploratory multi-case study research method was satisfactory with regard to achieving nuanced and in-depth results of some relationships between structural and process elements of provision of cognitive services. The research method can be considered an important supplement to the existing literature on the sustainability of cognitive services.

The relevance of political prestudies for implementation studies of cognitive services in community pharmacies.

BACKGROUND: Studies of cognitive services implementation in the pharmacy sector traditionally focus on individual and/or organizational factors to explain why some pharmacies are successful and others are not. The social and political context of the origins of these services is rarely part of the analysis. Researchers and practitioners in the field of pharmacy practice research are increasingly being encouraged to take into account the specific political and societal climate which often plays a defining role in the success or failure of cognitive services implementation in community pharmacies. OBJECTIVE: The aim of this article is to argue for the inclusion of political pre-studies as part of the study design for implementation studies on reimbursed services in community pharmacy. METHODS: A political pre-study of the Inhaler Technique Assessment Service (ITAS) introduced in Denmark in 2004 serves as an example of this approach and is described in detail. Documentary analysis was used in order to gain knowledge of the political background of the ITAS. RESULTS: Political pre-studies provide a more precise understanding of the background of the cognitive services and the way they are being performed, thereby supporting more valid results for subsequent implementation studies. CONCLUSION: Political pre-studies were shown to be a useful prerequisite when designing implementation studies of cognitive services in community pharmacies and can provide valuable insight into the ultimate success or failure of these services.

The lay public's explicit and implicit definitions of drugs.

BACKGROUND: The research project: Public Beliefs about Medicine was initiated in 2001, aiming at exploring people's views, hopes, and fears with respect to drugs/medicines, now and in the future. OBJECTIVES: A part of the research project mapping public beliefs about medicines aimed at getting the public to discuss definitions of drugs/medicines to grasp their explicit and implicit definitions and understand their point of reference when using the term(s). METHODS: Eight focus groups were conducted in urban and rural Iceland, with 42 participants of both genders and varying age, a fifty-fifty mix of lay and educated groups. The interviews were transcribed verbatim and excerpts translated into English. RESULTS: The direct question about definition of drugs generally resulted in a consensus among the informants about drugs/medicines being used to combat diseases and/or symptoms. Some included only prescribed or physician-recommended drugs in their definitions, others also over-the-counter products. Inclusion/exclusion of vitamins, food supplements, herbal remedies, functional foods, and illicit drugs was discussed without consensus and defining drugs in chemical terms or as interfering with bodily functions also occurred. New nuances emerged spontaneously later in the discussions, like viewing drugs as profit-making products, preferably prudently marketed, wishing information about "new release" drugs for the informants' diseases, and being concerned about side effects, overuse, misuse, and abuse. Other implicit definitions included viewing drugs as a product-service package, or as a necessary evil and/or as products with increasing potency and associated future problems or considering drugs to exert unreliable minor influence. CONCLUSION: Professionals should be aware of the variety of lay people's drug definitions when discussing drugs/medicines with them to avoid misunderstandings caused by definition discrepancies.

Actual and perceived provision of pharmaceutical care in Danish community pharmacies: the pharmacists' opinions.

OBJECTIVE: The study explores characteristics of community pharmacies with respect to implementing pharmaceutical care activities. The article addresses the provision of pharmaceutical care at reality level, perceived level and policy level. METHOD: A cross-sectional questionnaire was sent to all Danish community pharmacies to investigate the provision of pharmaceutical care (n=288). The respondents were pharmacists. Pharmaceutical care activities were operationalised by detecting and identifying medicine-related problems, setting goals to solve medicine-related problems, and documenting efforts to solve them. A non-respondent analysis was also performed. MAIN OUTCOME MEASURE: The identification of medicine-related problems (from self-report) was used as a proxy measure of pharmaceutical care activities and compared to pharmacies' self-reported provision of pharmaceutical care. RESULTS: The survey response rate was 75.7. The characteristics of pharmacies that detected medicine-related problems differed from those of pharmacies with only a perceived provision of pharmaceutical care. Pharmacies that actually detected medicine-related problems focused on external cooperation regarding their pharmacy activities. CONCLUSION: The profiles of the perceived providers of pharmaceutical care and the respondents that detected medicine- related problems were distinct, thus indicating two separate groups of pharmacies. Pharmaceutical care has only been implemented in Denmark to a limited extent. This may be explained in part by the top-down implementation strategy conceived by the proprietor organisation.

The argument for pharmaceutical policy.

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.

A lay prescription for tailor-made drugs--focus group reflections on pharmacogenomics.

This study explores the lay view of pharmaceutical research and development--specifically pharmacogenomics. Forty-two persons participated in eight focus groups in Iceland. Participants were asked to comment on a future scenario consisting of predictions made by researchers concerning the consequences of the Human Genome Project over the next 40 years, and asked to give advice to politicians and the pharmaceutical industry. A dominating theme in the focus groups was the expectation that drugs developed based on pharmacogenomics will be more expensive than conventional mass produced drugs and concerns were voiced that this new technology would lead to inequalities locally and globally.

Interviewing the moderator: an ancillary method to focus groups.

There has been an upsurge of academic interest in using focus groups (FGs) as a main or stand-alone qualitative method. In this article, the authors introduce a recently developed ancillary method to FGs called interviewing the moderator. The method is employed immediately after an FG and consists of a one-on-one interview with the FG moderator by another member of the research team. The authors argue, with reference to a specific study, that interviewing the moderator adds a new and valuable dimension to group interviews used in research. They describe how this method came about and provide a concrete example of its use in a recently completed research project. They discuss several advantages of the interview, among them that it provides information about group interaction and participant behavior, and furnishes additional data on what is discussed when the tape recorder is turned off.

Using health technology assessment to put pharmaceutical care on the political agenda.

Pharmaceutical care is a widely accepted strategy in the world of pharmacy, as well as a topic of interest in pharmacy practice research. Most people in the field would agree that it is unfortunate that so little is known about pharmaceutical care outside the world of pharmacy. There is also wide agreement that the further development of pharmaceutical care requires that policymakers become aware of, accept and ultimately support it. Although attempts have been made, we have not yet managed to capture the attention and support of policymakers, including politicians. In this article we argue that the way to get the attention of policymakers/politicians is by changing the way we communicate with them, as a means of overcoming some of the barriers we normally meet when introducing pharmaceutical care. We suggest that one possible way of getting their attention and subsequent support is by gaining a better understanding of the way policymakers work in general and then adjusting our argumentation for pharmaceutical care to better fit into their rationality and work habits. In this article, we elaborate on this idea and discuss how proponents of pharmaceutical care can use 'health technology assessment' to argue their case.

The lay user perspective on the quality of pharmaceuticals, drug therapy and pharmacy services--results of focus group discussions.

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.

Changes in self-concept while using SSRI antidepressants.

In this study, the authors analyze how younger women see themselves within the context of using the antidepressants selective serotonin re-uptake inhibitors (SSRIs). Twelve in-depth interviews and 6 reinterviews were conducted with a community-based sample of women who had been taking SSRIs between 1 and 4 years. The empirical analysis revealed that SSRI users passed through stages in their careers as medicine users, these stages corresponding to how the users thought and felt about themselves. Four major changes in self-concept emerged: distressed and needing help, conflicts about taking the medicine, improvements in condition, and problems discontinuing the medicine. Users evaluated themselves from what they believed was the perspective of society, and the way they saw themselves was closely related to how they felt they functioned in everyday life.