Mindful organizing in patients' contributions to primary care medication safety

Abstract Background There is a need to ensure that the risks associated with medication usage in primary health care are controlled. To maintain an understanding of the risks, health‐care organizations may engage in a process known as “mindful organizing.” While this is typically conceived of as involving organizational members, it may in the health‐care context also include patients. Our study aimed to examine ways in which patients might contribute to mindful organizing with respect to primary care medication safety. Method Qualitative focus groups and interviews were carried out with 126 members of the public in North West England and the East Midlands. Participants were taking medicines for a long‐term health condition, were taking several medicines, had previously encountered problems with their medication or were caring for another person in any of these categories. Participants described their experiences of dealing with medication‐related concerns. The transcripts were analysed using a thematic method. Results We identified 4 themes to explain patient behaviour associated with mindful organizing: knowledge about clinical or system issues; artefacts that facilitate control of medication risks; communication with health‐care professionals; and the relationship between patients and the health‐care system (in particular, mutual trust). Conclusions Mindful organizing is potentially useful for framing patient involvement in safety, although there are some conceptual and practical issues to be addressed before it can be fully exploited in this setting. We have identified factors that influence (and are strengthened by) patients’ engagement in mindful organizing, and as such would be a useful focus of efforts to support patient involvement.


| Mindful organizing and patient safety
High-reliability theory 10,11 attempts to characterize what organizations that avoid failure in high-risk activities do to maintain reliability.
According to Weick & Sutcliffe,11 so-called high-reliability organizations (HROs) demonstrate particular characteristics in the way they operate: anticipating problems (being aware of what is happening in the work system; being alert to ways in which an incident could occur; looking beyond simplistic explanations for incidents); and containing problems (being prepared to deal with contingencies; using relevant expertise regardless of where it is situated within the organizational hierarchy). Vogus & Sutcliffe 12 proposed "mindful organizing" as a collective mental orientation in which the organization continually engages with its environment, reorganizing its structures and activities as necessary, rather than mindlessly executing plans in ignorance of the prevailing circumstances. This is a dynamic social process, consisting of specific actions and interactions between those engaged in frontline organizational work. It creates the context for thought and behaviour across the organization, but is relatively transient and so needs to be actively maintained. 11 The extent to which high-reliability theory applies to organizational safety in general, and patient safety in particular, has been the subject of some debate. 13, 14 Leveson et al 15 noted that high-reliability theory was based on a specific type of organization-one in which the work system is relatively stable and its characteristics well understood-and argue that it is not generalizable to others. They further argue that reliability and safety are not necessarily equivalent or even compatible properties of a work system; therefore, highreliability theory is less applicable to safety than has been assumed.
However, Hollnagel 16,17 and Sujan et al 18 conceive of safety in terms of resilience-an organization's capacity to maintain successful work in the face of varying conditions. Hollnagel attributes resilience to an organization's mindfulness (in Weick's sense of the term), thus implying a link between high-reliability theory and organizational safety. Similarly, Hopkins 19 argues that the characteristics of a HRO and the components of safety culture suggested by Reason 20  While there appears to be convergence between the various concepts described here (i.e. high-reliability organizing, resilience and safety culture), a particular insight offered by the literature on mindful organizing is to emphasize its grounding in social relations. [23][24][25] In other words, the collective capacity to understand, anticipate and respond to problems both depends on and subsequently provides a structure for social interactions such as collaboration and negotiation. 23,26 The potential relevance of this insight to patient safety is demonstrated by examining the issue of patient involvement.

| Patients' contributions to medication safety
Previous research suggests that patients could be involved in the prevention of safety issues. [27][28][29][30] Roles for patients include reporting adverse events, notifying or questioning health-care professionals in the case of any concerns, and providing relevant information about their medicines or health conditions. [31][32][33][34][35] Yet, involving patients in safety is not necessarily a straightforward matter. First, involvement occurs in the context of a relationship between patients and healthcare professionals, such that patients feel more inclined to involve themselves when they perceive that they will be treated with respect and their contributions heard and taken seriously. [36][37][38] Indeed, a study of patients' perceptions about threats to safety 39 found that a breakdown in the relationship between patient and clinician was a more prevalent concern than was a technical error such as an adverse drug event, despite the latter typically being the main concern of health-care professionals. A second issue is that patients' involvement is informed by their understanding of the problem at hand.
Patients vary in their belief that safety is a priority in their care, or even a distinct issue (as opposed to being an assumed part of their care); they also draw upon accumulated knowledge and experience about their care in deciding whether and how to act. 37,40,41 Third, patients will be more inclined to become involved in safety activities if they perceive that they have the capacity and means to do so and that doing so will have a positive effect. 8,37,41 From a mindful organizing perspective, patient involvement might be conceptualized as a set of interactions between patients and health-care professionals that maintain collective "mindfulness" about safety issues, that is an awareness of potential or impending patient safety hazards and a capacity for acting on such insights. 14 Through these interactions, patients and their families or carers can contribute to mindfulness by amplifying otherwise weak signals of patient safety problems, questioning issues that would otherwise be taken for granted, and raising concerns that would otherwise be missed. Table 1 describes some examples of potential contributions that follow from the elements of mindful organizing listed by Weick et al. 11,42 Given its apparent relevance to patient safety, our study aimed to examine ways in which patients might contribute to mindful organizing. To do so, we drew from primary care patients' experiences of dealing with medication safety issues.

| Design and sampling
The study used a qualitative design. The sampling frame was members of the public in North West England and the East Midlands who either had a long-term health condition requiring medicines usage, were taking several medicines, had previous experience of problems with their medicines or were carers of people in any of these groups.
This frame was chosen on the basis of evidence that patients with long-term conditions or on multiple medications are at increased risk of medication-related problems. 43

| Data collection
Data were collected primarily through focus groups. The size of each group ranged from 3 to 11 participants, depending on participant availability. One-to-one interviews were conducted with participants who were unable to attend a focus group. Each focus group or interview was led by one member of the research team (DLP, SG, PJL, KM or NS), with another member of the research team, or a layperson from our research group's public and patient involvement panel, acting as a cofacilitator. Three focus groups were conducted for participants who did not speak English as a first language: 1 in Urdu; 1 in Hindi; and 1 in British Sign Language (BSL). For the Urdu and Hindi groups, a researcher who was fluent in the respective language acted as the lead facilitator, with a member of the research team as cofacilitator. The third group was facilitated by DLP with a BSL interpreter external to the research team acting as cofacilitator.
A semi-structured topic guide was used to guide each discussion. This included the following topics: problems that participants had experienced with medicines; their interactions with doctors and pharmacists; their own contribution to safe medication use; their knowledge of medication reviews; and adverse event reporting.
Each session lasted for between 75 and 120 minutes and, with the consent of all participants, was audio-recorded and transcribed.

| Data analysis
The transcripts were analysed using an inductive thematic approach. 44 Initially, the focus of the analysis was on instances of patients being involved, or attempting to be involved, in patient safety activities. Four members of the research team (DLP, SG and PJL and KM) separately reviewed the same 3 transcripts within the data set to identify emerging themes related to patient involvement. The research team members then discussed and agreed on a set of themes that appeared to distinguish between the successful and unsuccessful attempts at involvement described by participants. These themes were subsequently applied across the whole data set by 3 of the researchers (DLP, SG and PJL). When comparing the participants' accounts, the first author, who was familiar with safety science research, noted that the accounts varied in the extent to which they demonstrated the elements of mindful organizing listed in Table 1.
Therefore, literature on this topic was used to inform interpreta-

| FINDING S
A total of 126 participants took part in a focus group or interview.

| Knowledge
Participants' accounts referred to their assimilating and using knowledge, either about the clinical indication for their medication use or about the system within which their medicines were supplied. Some participants-typically those with long-term or complex medica-

| Communication
The experience of the mental health patient highlights the interactive nature of mindful organizing; in that instance, the patient's work in preventing an adverse event assumed that the health-care professionals recognized and informed her about relevant sources of risk.
In our study, communication between patients and health-care professionals was often mentioned in relation to patients' involvement in medication safety activities.

| Artefacts
The physical artefacts involved in medicines management provide further ways to support mindful organizing. As suggested in the previous example, medication labels and information leaflets provided a standardized source of knowledge about medicines, which alerted several of the participants to potential medication risks. In doing so, they facilitated a preoccupation with failure and a reluctance to simplify operations.

[Renal conditions group]
However, it was evident from the data that medication labels and leaflets were used inconsistently across the sample. One barrier that affected some of the participants was a lack of accessibility, due to either the format (in the case of the visually impaired group) or language difficulties (in the case of the hearing-impaired and Asian elder groups).
From a mindful organizing perspective, these problems highlight the value of sensitivity to operations, which would facilitate patients and health-care professionals to collaborate in addressing the communication needs of the former. Both accounts illustrate how a commitment to resilience may be present in, or absent from, the design and supply of medicinal products. Furthermore in the second example, the mindlessness that is represented in the medication's colour-coding is compounded by an apparent lack of compensatory mindfulness on the part of the patient, who might otherwise demonstrate a sensitivity to operations by raising the problem with those involved in medication supply.

| Relationships and trust
Implicit to all of the participants' accounts is a common theme: their trust in the health-care system. There are a number of ways in which trust appears to operate. In some cases, the participants suggested a relatively high level of trust in the system to work as they expected (eg when assuming that health-care professionals would detect and communicate all prescribing hazards). In others, the participants suggested a relatively low level of trust (eg when doubting how seriously one's concerns about medication are being taken by the GP).
The participant's trust could be appropriately placed (eg if medicines information sought from a GP or pharmacist is correct) or inappropriately placed (eg if medication is misidentified). Some participants referred to the use of "trusted" collaborators or aids, which varied in terms of their formality and their degree of improvisation.

| D ISCUSS I ON
Our findings illustrate that patients could potentially contribute to the "mindfulness" of medicines management. This potential is realized through 4 interacting processes: assimilating and applying knowledge about medication risks; communicating with health-care professionals; using artefacts; and recognizing the level of trust that can be placed in each of the parties involved. Conversely, a weakness or absence of these processes will limit the contribution that a patient can make. Also, while these processes contribute to mindful organizing, they are in turn informed and shaped by the mindful organizing that occurs.
Given that mindful organizing is considered to be grounded in social interactions and serves to improve understanding of on-going risks, it would appear to lend itself to the examination of patient involvement in safety. However, some conceptual issues arise in relation to our study findings. First, as described in the previous section, trust can operate in various ways. In general terms-at least, with regard to health-care professionals and their own managers-there appears to be a positive relationship between trust and mindful organizing, 22 and a high level of trust has been found to enhance the relationship between mindful organizing and medication error rates. 45 A further consideration, though, is the argument by Entwistle  argue that it does, then a question arises as to what was intended by the patient behaviours described in the current study. It would seem that many of the behaviours were intended to help ensure safe medication usage; possibly they were knowingly motivated by particular aspects of mindful organizing (eg a concern about potential failures).
Whether they were explicitly intended to achieve mindful organizing However, we also note the argument made previously 47 that while mindful organizing needs conscious effort, its role may be to interact with, rather than completely replace, less mindful routinized behaviour that presumably can be sustained with less effort on a day-to-day basis. In fact, if mindful organizing is held to be effortful, excessive reliance on health-care professionals to provide it may be undesirable or even counterproductive given the burdens already imposed by their work. 49 Our findings provide additional insight into the circumstances under which patient involvement occurs. Applying the notion of mindful organizing highlights the importance of considering how patients' actions interact with other parts (human or artefact) of the medicines management system. In other words, the extent to which patient action or inaction contributes to medication safety depends on the extent to which it complements other risk controls present in the system. Mindful organizing on the part of patients can compensate to a degree for a lack of mindful organizing on the part of health-care providers and therefore is beneficial in its own right. However, a lack of reciprocation of, or support for, a patient's efforts in mindful organizing could lead to them being undermined or thwarted, possibly without either party realizing this is the case.
Alternatively, these efforts may be successful in mitigating risks but, if the patient's work is unseen, the risks themselves may remain obscured too; hence, the system is assumed to be safer than it actually is. Therefore, patient involvement should not be treated simply as an independent safety intervention, and nor should it be assumed or expected to occur of its own accord; rather, it should be treated as a deliberate strategy to be integrated with other safety-related activities within the medicines management system, as well as depending on the interest and ability of individual patients. 34,50 A mindful organizing approach to involving patients in safety might, though, raise some issues in implementation. As mindful organizing serves to amplify signals of potential risks, one issue concerns the need for a way to distinguish those signals that accurately point to risks from those that are irrelevant. 23 Another issue concerns the foundation of mindful organizing on tight social coupling around a set of core values. 42 Previous studies have noted that patient safety is not objective but contingent and negotiable between the different parties involved. 37,40 In which case, how are the core values regarding patient safety agreed between patients and health-care professionals? It is difficult to provide any definitive answers to these issues on the basis of our current data. We surmise that they might be resolved between patients and health-care professionals-at least in part-on the basis of the factors identified in this study (eg as they develop mutual knowledge about risks and trust in each other's judgement).
At a broader level, a mindful organizing approach may be supported