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Bias is an ambiguous term, defined in different ways. In conventional usage, it indicates unwarranted prejudice. However, in health research, the notion that bias is invariably bad is biased. Although research bias is an error that is always harmful, researcher bias is a tendency to think in a particular way that may obscure or illuminate attempts to address research questions. Researcher bias begins with pre-judgements whose continuing evaluation infuses the subjectivity of researchers as persons who are socially situated in health sciences focusing on human subjects. Two sets of conditions can make this bias in health researchers useful. The first is volume control. Researchers can vary the loudness of their own and other voices in different research environments. The second condition is smart working. It balances researcher bias against analytic thinking to work creatively with irregularity and uncertainty. Thus, health researchers need to bring their biases to consciousness. A dialectical approach can then engage the biases as conversational partners to innovate health policy that is informed by principles including transparency, good faith and tolerance. Less critical than whether researchers are biased is whose interests their bias serves given their positionality and role.

Objective: This study investigated whether previously identified modifiable risk factors for dementia were associated with cognitive change in Māori (indigenous people of New Zealand) and non-Māori octogenarians of LiLACS NZ (Life and Living in Advanced Age; a Cohort Study in New Zealand), a longitudinal study. Method: Multivariable repeated-measure mixed effect regression models were used to assess the association between modifiable risk factors and sociodemographic variables at baseline, and cognitive change over 6 years, with p values of Results: Modifiable factors associated with cognitive change differed between ethnic groups. Depression was a negative factor in Māori only, secondary education in non-Māori was protective, and obesity predicted better cognition over time for Māori. Diabetes was associated with decreased cognition for both Māori and non-Māori. Conclusion: Our results begin to address gaps in the literature and increase understanding of disparities in dementia risk by ethnicity. These findings have implications for evaluating the type and application of culturally appropriate methods to improve cognition.

Stable, healthy families are the loto or heart of strong Pacific communities. This paper addresses the problem of a decline in the strength of Pacific families. It introduces and discusses the Tongan concept of O’ofaki, as the way in which shared, core relational commitments can bring Pasifika peoples together to support one another for health and community development. This process is based on a reciprocal sharing of social capital to promote cultural solidarity and social justice. We describe two studies by the lead author, through which the concept of O’ofaki emerged. The first study utilized an action research model while the second study focused on two Pasifika-centric research approaches: talanga, which is a Tongan word for interactive talking for a purpose, and the kakala (Tongan garland) research approach. The latter approach is incorporated within a general inductive methodology as well as luva—the dissemination of the results. Finally, the paper focuses on the components of O’ofaki and its application to Pasifika communities.

Body image research focuses almost exclusively on women or overweight and obesity or both. Yet, body image concerns among thin men are common and can result, at least in part, from mixed messages in society around how men qua men should dress and behave in order to look good and feel good. Stand-alone interventions to meet these different messages tend to provide men with little therapeutic relief. This conceptual paper draws on literature from the medical humanities; gender and body image studies; the social psychology of clothing; and the author's own lived experience to address this contemporary problem. The paper embraces visual culture as a resource that can frame discussion of how two sets of 'performativity' might reduce male anxiety about thinness. First, thin men could choose repeatedly to wear masculine-looking clothing, which could create their masculinity as a personal aesthetic that strengthens the confidence to harness masculine traits in healthy ways. Secondly, health and allied health service providers could promote and reinforce such dress behavior by offering advice that integrates aesthetic and functional aspects of clothing. Empirical studies are needed to test this dual model of performativity.

When investigating the etiology of diseases, epidemiological observational studies traditionally deemphasize psychosomatic associations. Exploring cognitive behavior provides an insight into how psychosomatic associations affect disease. Yoga philosophy identifies the kleshas (mental afflictions) of ignorance, ego, desire, hatred, and fear of death with disease. This is because individuals' perceptions and beliefs generate and reflect streams of thought that may shape their behavior and manifest as, or predispose them to, particular disease(s). The present study takes a yogic philosophical perspective to help elucidate unexplored associations between thinking about different aspects of life and the severity of Parkinson's disease (PD). The study involved a cross-sectional sample survey. Parkinson's New Zealand selected a random sample of 990 of its members. A self-completed questionnaire was sent to them. It asked questions about how often, over the previous 4 weeks, they had thought about 18 aspects of life commonly associated with the kleshas. A completed questionnaire was returned by 319 people (32%). Respondents thought most about family (87%), health (64%), rest and sleep (57%), food (53%), and the future (52%). They reported thinking least about work (48%), sex (45%), death (42%), and being virtuous (39%). A weak, but hypothesized positive, association (r = 0.2, p < 0.000) was detected between PD severity and thinking about death. The study could not determine whether thinking about death was (1) a cause or consequence of PD severity, and (2) a premorbid behavior. However, the possibility that stress associated with thinking about death accelerates PD progression is consistent with yoga philosophy and with neurophysiological mechanisms associated with the psychosomatic connections. The findings are worthy of future testing. A retrospective cohort study and qualitative research could deepen understanding about the role of kleshas in PD.

Purpose: Rehabilitation is commonly portrayed as care that seeks to enable persons who are disabled to recover as normal a state of well-being as their personal and social circumstances allow. In c...

Introduction We assessed the sensitivity and specificity of the Modified Mini–Mental State Examination (3MS) in predicting dementia and cognitive impairment in Māori (indigenous people of New Zealand) and non-Māori octogenarians. Methods A subsample of participants from Life and Living in Advanced Age: a Cohort Study in New Zealand were recruited to determine the 3MS diagnostic accuracy compared with the reference standard. Results Seventy-three participants (44% Māori) completed the 3MS and reference standard assessments. The 3MS demonstrated strong diagnostic accuracy to detect dementia with areas under the curve of 0.87 for Māori and 0.9 for non-Māori. Our cutoffs displayed ethnic variability and are approximately 5 points greater than those commonly applied. Cognitive impairment yielded low accuracy, and discriminatory power was not established. Discussion Cutoffs that are not age or ethnically appropriate may compromise the accuracy of cognitive screens. Consequently, older age and indigeneity increase the risk of mislabeled cognitive status., Highlights • The cutoffs between Māori and non-Māori octogenarians differed. • Dementia versus no dementia had good discriminant validity. • Applying the typical cutoff would likely lead to misclassification of cognitive function.

Emergency responders (police, fire, ambulance and defence force personnel) risk exposure to dangerous and traumatic events, and the possible subsequent development of post-traumatic stress disorder. Consequently, partners of these emergency responders risk developing secondary traumatic stress (STS) from vicarious exposure to the trauma through communication and engagement with their responders. A mixed-methods study of the partners of emergency responders in New Zealand examined the extent of such partner-associated STS. This article focuses on two research questions: to what extent were risk factors for STS identified within that population, and what did the participants believe may help them to mitigate the impact of STS. An online anonymous survey was developed and eligible participants completed a 17-item STS scale, a social support measure, and answered several open-ended questions. Of the 646 participants, twenty percent appear to be experiencing intrusion, arousal, and avoidance symptoms related to the trauma experienced by their responder. Almost half stated they have little or no emotional/informational support related to their responder&rsquo, s work. Thematic analysis of free-text responses identified the need for additional support and more direct communication/engagement from the organisations for partners to navigate their experiences of STS and the level of social support received and required. The authors conclude with recommendations to emergency responder organisations.

Background Austria has high health resource use compared to similar countries. Reclassifying (switching) medicines from prescription to non-prescription can reduce pressure on health resources and aid timely access to medicines. Since Austria is less progressive in this area than many other countries, this research aimed to elucidate enablers and barriers to it reclassifying medicines and make recommendations for change in the context of similar research conducted elsewhere. Methods Qualitative research using a heuristic approach was conducted in Austria in 2018. Informed by their own “insider” and “outsider” knowledge, the authors identified themes from personal interviews with 24 participants, including reclassification committee members, government officials and stakeholders, before comparing these themes with earlier research findings. Results Significant barriers to reclassification included committee conservatism, minimal political support, medical negativity and few company applications. Insufficient transparency about committee decisions, expectations of adverse committee decisions and a limited market discouraged company applications. Austria’s ‘social partnership’ arrangement and consensus decision making aided a conservative approach, but the regulator and an alternative non-committee switch process were enabling. Pharmacy showed mixed interest in reclassification. Suggested improvements include increasing transparency, committee composition changes, encouraging a more evidence-based approach by the committee, more pharmacy undergraduate clinical training, and companies using scientific advisory meetings and submitting high quality applications. Conclusion Removing barriers to reclassification would facilitate non-prescription availability of medicines and encourage self-care, and could reduce pressure on healthcare resources.

Person-centered care offers a promising way to manage clinicians' conscientious objection to providing services they consider morally wrong. Health care centered on persons, rather than patients, recognizes clinicians and patients on the same stratum. The moral interests of clinicians, as persons, thus warrant as much consideration as those of other persons, including patients. Interconnected moral interests of clinicians, patients, and society construct the clinician as a socially embedded and integrated self, transcending the simplistic duality of private conscience versus public role expectations. In this milieu of blurred boundaries, person-centered care offers a constructive way to accommodate conscientious objection by clinicians. The constitutionally social nature of clinicians commits and enables them, through care mechanisms such as self-care, to optimize the quality of health care and protect the welfare of patients. To advance these conditions, it is recommended that the medical profession develop a person-centered culture of care, along with clinician virtues and skills for person-centered communication.

Current rehabilitation models emphasize therapy that attempts to return to "normal" the lives of persons who are disabled. An opportunity is available to scrutinize whether this recovery orientation of rehabilitation is necessarily optimal.This conceptual article uses reasoning, informed by experience and a nonsystematic review of literature across diverse disciplines.For some persons with disability, optimizing recovery might be unwanted or insufficient. To expand rehabilitation, we append the Latin "ultra", beyond, to "habilitare", make fit. The resulting term, "ultrabilitate", commits to human flourishing that moves persons toward, around or beyond recovery of particular functioning.By expanding the scope of disability management, ultrabilitation could inform therapy selection and facilitate human flourishing. Empirical research is needed to test our ideas. Implications for rehabilitation Despite significant progress, rehabilitation limits some people with disabilities. Modern health systems still benchmark therapy for rehabilitation against "normal" or species-typical standards to aid recovery. "Ultrabilitation", meaning "beyond fitness", promotes flourishing, either without an interest in recovery or in moving toward, beyond or around recovery. Biological, social and technological conditions are needed to support ultrabilitation. Ultrabilitation complements rehabilitation when rehabilitation is not sufficient to optimize functioning and personal growth.

Background In 2012, New Zealand reclassified trimethoprim to allow specially trained pharmacists to supply it without a prescription to women with symptoms suggesting uncomplicated cystitis, under strict criteria for supply. Objective To assess how this policy change allowing pharmacist supply of trimethoprim affected overall antibiotic supply. Setting Randomly selected community pharmacies throughout New Zealand. Methods Data were collected in pharmacies before the implementation ('baseline') and 1 year later ('post-implementation'). Pharmacy staff recorded prescription and nonprescription supplies for treatment or prevention of suspected urinary tract infections. Women with a prescription for treatment or prevention of presumed urinary tract infection or purchasing a non-prescription medicine for this purpose were invited to self-complete a questionnaire. National prescribing data were extracted for trimethoprim, nitrofurantoin and norfloxacin. Main outcome measure Antibiotic use in women with UTIs from dispensed prescriptions (baseline and post-implementation) and pharmacist-supplied trimethoprim (post-implementation), particularly focusing on women aged 16-65 years with an antibiotic for presumed cystitis without complicating features. Results Baseline data were provided by 139 pharmacies, 120 of which provided post-implementation data. In women with presumed cystitis without complicating features, prescriptions before and after the implementation were primarily for trimethoprim. Overall antibiotic use, and use of second-line agents did not increase post-implementation. Pharmacist-supplies of trimethoprim were modest nearly 1 year after the service started. Conclusion Supply of trimethoprim by specially trained pharmacists working within strict criteria for supply appeared to have little overall effect on antibiotic use. Further research on patient outcomes, resistance and changes over time is recommended.

There is now broad agreement that ideas like person-centred care, patient expertise and shared decision-making are no longer peripheral to health discourse, fine ideals or merely desirable additions to sound, scientific clinical practice. Rather, their incorporation into our thinking and planning of health and social care is essential if we are to respond adequately to the problems that confront us: they need to be seen not as “ethical add-ons” but core components of any genuinely integrated, realistic and conceptually sound account of healthcare practice. This, the tenth philosophy thematic edition of the journal, presents papers conducting urgent research into the social context of scientific knowledge and the significance of viewing clinical knowledge not as something that “sits within the minds” of researchers and practitioners, but as a relational concept, the product of social interactions. It includes papers on the nature of reasoning and evidence, the on-going problems of how to ‘integrate’ different forms of scientific knowledge with broader, humanistic understandings of reasoning and judgement, patient and community perspectives. Discussions of the epistemological contribution of patient perspectives to the nature of care, and the crucial and still under-developed role of phenomenology in medical epistemology, are followed by a broad range of papers focussing on shared decision-making, analysing its proper meaning, its role in policy, methods for realising it and its limitations in real-world contexts.

Objective. A systematic review with a meta-analysis explored effects of cognitively loaded physical activity interventions on global cognition in community-dwelling older adults (≥65 years of age) experiencing mild cognitive impairment (MCI), compared to any control. Methods. A literature search was conducted in 4 databases (MEDLINE [OvidSP], PubMed, CINAHL, and the Cochrane Central Register of Controlled Trials [Wiley]) from inception until January 30, 2018. The meta-analysis was conducted with Review Manager 5.3. Results. Six randomized controlled trials (RCTs) with 547 participants were identified. The interventions ranged from 4 to 52 weeks. Baseline and initial follow-up assessments were used. The primary pooled analysis of all RCTs demonstrated a nonsignificant trivial effect (standardized mean difference [SMD] 0.07, 95% confidence interval [CI] −0.44 to 0.58) favoring the intervention. In pooled subanalysis of 4 RCTs (n = 405) using the same global cognition measure (Mini-Mental State Examination) and duration of intervention >12 weeks, the intervention group achieved a small but significant improvement for global cognition (SMD 0.45, 95% CI 0.14 to 0.75). Conclusion. When all the RCTs were pooled, the effect of cognitively loaded physical activity intervention on global cognitive function in older adults with MCI remained unclear. The subgroup analysis provides translation evidence for future RCT study designs.

Introduction: To estimate the cognitive-load of self-reported physical and cognitive activities by New Zealand’s (NZ) indigenous population (Māori) and non‑Māori from the Life and Living in Advanced Age‑Cohort Study New Zealand (LiLACS NZ). Methods: Three-round panel Delphi exercise in NZ involving six panellists across an expert rater group and a peer-rater agroup of Māori and non‑Māori respectively, via web-based and face‑to‑face discussion. Results: In Round i (pre-Delphi exercise) the investigator group, gathered and categorised data from LiLACS NZ and developed a 9-point Likert-scale to rate the cognitive-load. Round ii panellists each rated the cognitive‑load of each activity. If a priori specified criteria were not met, then round iii involved a face‑to‑face meeting to discuss and re-rate activities on which consensus was lacking. Conclusions: Māori reached consensus in round ii while non‑Māori did so in round iii. Panellists provided a formal consensus-based cognitive-load rating for 181 activities separately for Māori and non‑Māori. Keywords: three to five keywords: Delphi Technique, physical activity, ageing, cognitive activity

The University of Auckland, like many tertiary educational institutions, expects undergraduates and postgraduates to leave the institution equipped not only with specialist knowledge, but with a set of intellectual skills, capacities and personal attributes. Included in this suite of transferable skills is academic and information literacy (AIL). This case study reports on the collaborative process, content development and outcomes of integrating AIL into the curricula of two Population Health research methods courses, one at postgraduate level and another at undergraduate level. The study shows how experiences gained from designing an online assessment for the postgraduate course, provided evidence to develop scaffolded activities and online summative and formative assessment design for the undergraduate course. The analysis of the quality of completed student coursework showed that interventions assisted students to think more critically and develop understanding of the key elements of the research process and methodology.

Kava drinking in kava clubs has become an intrinsic part of Tongan Pasifika culture. Perceived effects and reasons for kava consumption are not fully understood. This study explored these issues using the culturally safe, Pasifika qualitative research approaches of Kakala and Talanga. Group interviews were held with a convenience sample of 104 Tongan men across 10 kava clubs in Tonga and New Zealand. A general inductive approach was used to analyse the interviews. Participants in both countries reported that kava use is socially sanctioned and easily accessible. Kava clubs provide an opportunity to learn about Tongan culture, socialise and are a safe way to relieve stress and boredom. However, kava consumption could reduce members’ productivity, contribute to ill-health and increase stress on family relationships. It is vital that kava use amongst Tongans is addressed in a way that deals with the negative impacts but protects its benefits. There is an opportunity to educate men about the health effects of kava. To enact this opportunity and solve this widespread issue, partnership between kava clubs, the church and the Tongan community is needed. A multi-agency engagement with kava club members and Tongan society may therefore be the best approach to minimize risks and optimize benefits of kava use.

Something important is happening in applied, interdisciplinary research, particularly in the field of applied health research. The vast array of papers in this edition are evidence of a broad change in thinking across an impressive range of practice and academic areas. The problems of complexity, the rise of chronic conditions, overdiagnosis, co-morbidity, and multi-morbidity are serious and challenging, but we are rising to that challenge. Key conceptions regarding science, evidence, disease, clinical judgement, and health and social care are being revised and their relationships reconsidered: Boundaries are indeed being redrawn; reasoning is being made "fit for practice." Ideas like "person-centred care" are no longer phrases with potential to be helpful in some yet-to-be-clarified way: Theorists and practitioners are working in collaboration to give them substantive import and application.

Nurses routinely engage in pattern recognition and interpretation in qualitative research and clinical practice. However, they risk spontaneously perceiving patterns among things that are not meaningfully related. Although all people are prone to this cognitive bias of "apophenia", nurses may be at increased risk because they commonly produce or at least use qualitative research that can be highly interpretive. Qualitative researchers have been silent on the risk of apophenia and hence on exploring how attention to apophenia could help to indicate and manage such unconscious biases. Therefore this conceptual paper suggests how, in disciplines like nursing, researchers could attend to and use reflexivity on signs of possible apophenia to help bring unconscious biases to awareness. Within safe communities of professional practice, the researchers could cooperate with trusted peers to reflect on how and why they may each perceive patterned phenomena from different perspectives. If one reason is that the researchers, for example, appear to exhibit particular unconscious biases, then dialogue could help them to become aware of, and reflect on the biases. This expansion of researchers' consciousness of bias could inform the management of apophenia and enhance the quality of qualitative research and modern nursing practice.

INTRODUCTION Nutrition care refers to practices conducted by health professionals to support patients to improve their dietary intake. General practitioners (GPs) are expected to provide nutrition care to patients for prevention and management of chronic disease. AIM This study explores GPs’ opinions regarding nutrition care provision to patients with chronic disease. METHODS An interpretive descriptive approach to qualitative research using seven semi-structured focus groups with 48 GPs in Auckland was used. Focus groups investigated how GPs felt about providing nutrition care; the perceived barriers to and support required for this care; the development of further nutrition knowledge and skills; and possible roles for Practice Nurses. Recorded interviews were transcribed verbatim and analysed using a thematic approach. RESULTS GPs indicated routine provision of basic nutrition care to patients with chronic disease, but perceived their limited consultation time and nutrition competence constrained their capacity to provide nutrition care. GPs felt they needed further information to provide culturally, socially and economically sensitive nutrition care. GPs displayed variable opinions on the benefits of developing their nutrition knowledge and skills, and the idea of Practice Nurses providing nutrition care. CONCLUSIONS Despite perceiving that nutrition care is important for patients with chronic disease and facing barriers to providing nutrition care, GPs appear reluctant to further develop their knowledge and skills and for Practice Nurses to provide this care. Strategies to enhance GPs’ nutrition-related self-efficacy, nutrition cultural competence and attitudes towards further training care may be warranted.

Modern technologies sanction a new plasticity of physical form. However, the increasing global popularity of aesthetic procedures (re)produces normative beauty ideals in terms of perfection and symmetry. These conditions limit the semblance of freedom by people to control their own bodies. Cultural emancipation may come from principles in Eastern philosophy. These reveal beauty in authenticity, including imperfection. Wabi-sabi acclaims beauty in common irregularity, while kintsugi celebrates beauty in visible signs of repair, like scars. These principles resist pressure to medicalize dissatisfaction with healthy bodies and invite multi-sited interventions to educate taste and aesthetic choices.

Objective To identify factors associated with differences between developed countries in reclassifying (switching) medicines from prescription to non-prescription availability. Methods Cross-national qualitative research using a heuristic approach in the US, UK, Japan, Australia and New Zealand, supplemented by data from Canada, Denmark, the Netherlands and Singapore. In-depth interviews with 80 key informants (65 interviews) explored and compared factors in terms of barriers and enablers to reclassification of medicines in each country. Document analysis supplemented interview data. Results Each country had a unique mix of enablers and barriers to reclassification. Enablers included government policy (particularly in UK), pharmacist-only scheduling (particularly in Australia and New Zealand) and large market size (particularly in the US and Europe). Local barriers included limited market potential in small countries, the cost of a reclassification (particularly in the US), competition from distributors of generic medicines, committee inconsistency and consumer behavior. UK had more enablers than barriers, whereas in Australia the opposite was true. Conclusions Different factors limit or enable reclassification, affecting consumer access to medicines in different countries. For countries attempting to reduce barriers to reclassification, solutions may include garnering government support for reclassification, support and flexibility from the medicines regulator, having a pharmacy-only and/or pharmacist-only category, providing market exclusivity, ensuring best practice in pharmacy, and minimizing the cost and delays of reclassification.

Last year saw the 20th anniversary edition of JECP, and in the introduction to the philosophy section of that landmark edition, we posed the question: apart from ethics, what is the role of philosophy ‘at the bedside'? The purpose of this question was not to downplay the significance of ethics to clinical practice. Rather, we raised it as part of a broader argument to the effect that ethical questions – about what we should do in any given situation – are embedded within whole understandings of the situation, inseparable from our beliefs about what is the case (metaphysics), what it is that we feel we can claim to know (epistemology), as well as the meaning we ascribe to different aspects of the situation or to our perception of it. Philosophy concerns fundamental questions: it is a discipline requiring us to examine the underlying assumptions we bring with us to our thinking about practical problems. Traditional academic philosophers divide their discipline into distinct areas that typically include logic: questions about meaning, truth and validity; ontology: questions about the nature of reality, what exists; epistemology: concerning knowledge; and ethics: how we should live and practice, the nature of value. Any credible attempt to analyse clinical reasoning will require us to think carefully about these types of question and the relationships between them, as they influence our thinking about specific situations and problems. So, the answers to the question we posed, about the role of philosophy at the bedside, are numerous and diverse, and that diversity is illustrated in the contributions to this thematic edition.

Professor of Applied Philosophy, Department of Interdisciplinary Studies, MMU Cheshire, Crewe, UK Associate Professor, Department of Philosophy and Religious Studies, Old Dominion University, Norfolk, VA, USA PhD student, Faculty of Medicine, University of Toronto, Toronto, ON, Canada Associate Professor, Department of General Practice, University of Auckland, Auckland, New Zealand Director, Department of Family and Community Medicine, University of Toronto Joint Centre for Bioethics, Toronto, ON, Canada Assistant Professor, Department of Philosophy, Dalhousie University, Halifax, NS, Canada Assistant Professor, Department of Philosophy, University of Guelph, Guelph, Ontario, Canada Senior Lecturer, Department of Philosophy, University of Southampton, Southampton, UK Socrates Professor in Philosophy and Technology, Technical University, Eindhoven, The Netherlands

Background Widening access to medicines through reclassification (‘switching’) of medicines from prescription to non-prescription is an international trend generally welcomed by community pharmacists. Research has focused on scheduling and committee deliberations affecting reclassification, rather than industry aspects, despite industry's role in driving reclassifications. The research aimed to identify how pharmaceutical industry and product-related factors influence reclassification, and to explore stakeholder acceptability of government or third-party driven reclassifications. Methods Sixty-five in-depth, semi-structured interviews were conducted with 80 key informants (including representatives from regulatory bodies, industry, pharmacy and medicine) in developed countries including the United States, the United Kingdom, Japan, Australia, and New Zealand. The questions explored barriers and enablers to reclassification at the local (micro-), regional (meso-) and global (macro-) levels. Analysis of transcribed interviews entailed descriptive and thematic approaches. Results Pharmaceutical industry decisions to drive medicine reclassification reflect characteristics of the company, product, and external environment at all levels. For the company, financial factors, company focus (e.g. on prescription business versus non-prescription business), and capability in non-prescription medicines and reclassification were common influences. Products with significant non-prescription market potential and a well-known prescription medicine brand name most suited reclassification, usually near patent expiry. Barriers included immediate generic entry post-reclassification, and a short-term profitability and/or prescription business focus. Some countries allow government or a third-party (including pharmacy) to drive reclassifications, with examples of successful reclassifications ensuing. Some industry and other participants held concerns about this practice, particularly in the United States. Concerns included insufficient resourcing, and the pharmaceutical company's business, potentially encouraging product withdrawal or legal challenge. Conclusions This study is the first to explore both pharmaceutical industry factors affecting reclassification and acceptability of alternate drivers of reclassification. Factors beyond clinical safety and efficacy and the local reclassification environment can influence reclassification. Pharmacy-driven reclassification might be one alternative.