Towards an everyday ethics for medicines use: About people, medicines and multiplicity

Taking medicines is a natural part of everyday life for many people. Despite this, most ethical theories on medicines are about research and clinical use and do not include aspects of everyday life. In this article we sketch a new starting point for an ethical theory about medicines; an everyday ethics for medicines use. In the everyday, medicines use does not adhere to standardized practices or guidelines. Rather, what seems ethical about medicines use emerges in subtle everyday practices and the imaginaries we have about what medici- nes are and how they add to our daily lives. With empirical examples from ethnographic field studies about medicines use in everyday life we focus on the pharmaceutical health work that it requires to (re)establish the good everyday life with medicines, and in particular the ethical tensions that emerge in this work. To guide the empirical analysis, we take on Annemarie Mol’s notion of ontonorms to observe and describe the fundamental differen- ces that condition our experience and practices with medicines. From this post-humanist vantage point medicines are not merely material artefacts. Rather, they actively shape and transform the relations that we rely on when caring about others and ourselves. Thus, it becomes clear that taking medicines is also an ethical practice, and as an embedded ethics, it shapes the ways in which we care for others and ourselves in everyday life.For mange mennesker er det at tage medicin en naturlig del af hverdagen. Alligevel er langt det meste etik på lægemiddelområdet fokuseret på forskning og klinisk anvendelse og ikke på dagligdagen med medicin. I denne artikel tegner vi konturerne af et nyt udgangspunkt for etik om lægemidler; en hverdagsetik for lægemiddelbrug. Hverdagslivet med medicin lader sig ofte ikke beskrive og organisere i henhold til procedurer, guidelines og kvalitetsstandar- der. I stedet fremkommer det etiske igennem de ofte mere subtile forestillinger, vi gør os om, hvad lægemidlerne er og kan bidrage med i vores daglige liv. Gennem empiriske eksempler fra etnografiske feltstudier om medicinbrug i hverdagslivet zoomer vi ind på det medicinske sundhedsarbejde, som det kræver at (gen)skabe det gode hverdagsliv med medicin, og sær- ligt de etiske skisma, der ofte følger med. Til at guide den empiriske analyse tager vi afsæt i Annemarie Mols begreb ontonormer til at få øje på de grundlæggende forskelle, der betin- ger vores syn på og dermed vores praktiske handlinger med lægemidler. Lægemidler i denne post-humanistiske tankegang er ikke kun materielle objekter. De er aktivt med til at forme og forandre de relationer, hvorfra omsorg for os selv og hinanden udspringer. Herigennem bliver det tydeligt, at det at tage medicin også er en etisk praksis, og at den indlejrede etik påvirker måden, vi i hverdagslivet drager omsorg for os selv og hinanden på

Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts

OBJECTIVE: Improving synergy among regulation, health technology assessment (HTA) and clinical guideline development is relevant as these independent processes are building on shared evidence-based grounds. The two objectives were first to assess how convergence of evidentiary needs among stakeholders may be achieved, and second, to determine to what extent convergence can be achieved. DESIGN: Qualitative study using eight online dual-moderator focus groups. SETTING: Discussions had a European focus and were contextualised in four case studies on head and neck cancer, diabetes mellitus, multiple sclerosis and myelodysplastic syndromes. PARTICIPANTS: Forty-two experienced (over 10 years) European regulators, HTA representatives and clinicians participated in the discussion. INTERVENTIONS: Participants received information on the case study and research topic in advance. An introductory background presentation and interview guide for the moderators were used to steer the discussion. RESULTS: Convergence may be achieved through improved communication institutionalised in multistakeholder early dialogues, shared definitions and shared methods. Required data sets should be inclusive rather than aligned. Deliberation and decision-making should remain independent. Alignment could be sought for pragmatic clinical trial designs and patient registries. Smaller and lower-income countries should be included in these efforts. CONCLUSION: Actors in the field expressed that improving synergy among stakeholders always involves trade-offs. A balance needs to be found between the convergence of processes and the institutional remits or geographical independence. A similar tension exists between the involvement of more actors, for example, patients or additional countries, and the level of collaboration that may be achieved. Communication is key to establishing this balance

Are Drug Safety Advisories Compatible with Physicians’ Information Behaviour? Semi-Structured Interviews with General Practitioners about Direct to Healthcare Professional Communication

Physicians critically depend on up-to-date risk information when prescribing drugs, but they typically have little time to navigate the vast information. In the European Union, Direct to Healthcare Professional Communications (DHPC) letters are distributed to physicians to mitigate drug risks that emerge after market approval, but the letters show low impact. This study characterises general practitioners’ (GPs) information behaviour regarding drug safety and assesses the compatibility of DHPCs with the identified information behaviour. We conducted 17 semi-structured interviews and four follow-up interviews with Danish GPs about safety concerns and analysed them using Wilson’s model of information behaviour. We found that GPs primarily use an online drug monograph for point-of-care information needs and a newsletter from the authorities for clinical management strategies. They generally did not consider DHPCs a useful source of information. GPs argued that numerous sources contained the same information as the DHPC and believed these to be superior in terms of convenience, clinical relevance, and quality of evidence. A new digital mode of DHPC delivery from a public authority may improve the general adoption but also generated new problems. Overall, this suggests that DHPCs in their current form are not very compatible with information behaviour of GPs

The effectiveness of direct to healthcare professional communication : A systematic review of communication factor studies

BACKGROUND: Direct to healthcare professional communication (DHPC) is the prevalent regulatory measure to inform about and potentially mitigate newly identified drug risks in EU and USA. According to multiple studies and reviews, however, the effectiveness of DHPC to reduce risk is less than optimal. Prior systematic reviews have indicated that contextual, qualitative knowledge of communication factors related to the clinical setting is needed to further explain and supplement findings in quantitative effectiveness studies. OBJECTIVES: This article systematically reviews studies of DHPC and, on that basis, describes the communication factors that influence the effectiveness of DHPC in order to discuss future research trajectories. METHODS: PubMed, Scopus (including Embase) and Web of Science databases were searched for studies on communication about emergent drug risk to healthcare professionals, excluding studies limited to the quantifiable effect of communication. The search results were deductively categorized using the Communication Sequence Model. Then, prevalent themes within categories were identified and described using thematic analysis. RESULTS: A total of 16 studies published between 1993 and 2017 were included; 12 based on surveys, 2 on document analysis, and 2 primarily on interviews. The prevalent themes included "Health Care Professionals (HCPs) have less trust in communication from industry than authorities and medical associations", "HCPs have diverse preferences for how to receive drug risk information" and "Clinical usability of the presented information is less than optimal." CONCLUSION: Communication factors in DHPCs are multiple, multi-facetted and are examined primarily by surveys. Future research would benefit from identifying nationally dependent factors and employing methods that better provide knowledge on the qualitative reception and handling of drug risk communication

The effectiveness of direct to healthcare professional communication : A systematic review of communication factor studies

BACKGROUND: Direct to healthcare professional communication (DHPC) is the prevalent regulatory measure to inform about and potentially mitigate newly identified drug risks in EU and USA. According to multiple studies and reviews, however, the effectiveness of DHPC to reduce risk is less than optimal. Prior systematic reviews have indicated that contextual, qualitative knowledge of communication factors related to the clinical setting is needed to further explain and supplement findings in quantitative effectiveness studies. OBJECTIVES: This article systematically reviews studies of DHPC and, on that basis, describes the communication factors that influence the effectiveness of DHPC in order to discuss future research trajectories. METHODS: PubMed, Scopus (including Embase) and Web of Science databases were searched for studies on communication about emergent drug risk to healthcare professionals, excluding studies limited to the quantifiable effect of communication. The search results were deductively categorized using the Communication Sequence Model. Then, prevalent themes within categories were identified and described using thematic analysis. RESULTS: A total of 16 studies published between 1993 and 2017 were included; 12 based on surveys, 2 on document analysis, and 2 primarily on interviews. The prevalent themes included "Health Care Professionals (HCPs) have less trust in communication from industry than authorities and medical associations", "HCPs have diverse preferences for how to receive drug risk information" and "Clinical usability of the presented information is less than optimal." CONCLUSION: Communication factors in DHPCs are multiple, multi-facetted and are examined primarily by surveys. Future research would benefit from identifying nationally dependent factors and employing methods that better provide knowledge on the qualitative reception and handling of drug risk communication