video case study safety polypharmacy

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• Volume 11, Issue 2
• ‘It's all about patient safety’: an ethnographic study of how pharmacy staff construct medicines safety in the context of polypharmacy
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• http://orcid.org/0000-0002-7161-4355 Nina Fudge ,
• http://orcid.org/0000-0003-1261-9268 Deborah Swinglehurst
• Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London , London , UK
• Correspondence to Professor Deborah Swinglehurst; d.swinglehurst{at}qmul.ac.uk

Objective As polypharmacy increases, so does the complexity of prescribing, dispensing and consuming medicines. Medication safety is typically framed as the avoidance of harm, achievable through adherence to policies, guidelines and operational standards. Automation, robotics and technologies are positioned as key players in the elimination of medication error in the face of escalating demand, despite limited research illuminating how these innovations are taken up, used and adapted in practice. We explore how ‘safety’ is constructed and accomplished in community pharmacies in the context of polypharmacy.

Design and setting In-depth ethnographic case study across four community pharmacies in England (December 2017–July 2019). Data collection entailed 140 hours participant observation and 19 in-depth interviews. Practice theory informed the analysis.

Participants 33 pharmacy staff (counter staff, technicians, dispensers, pharmacists).

Results In their working practices related to polypharmacy, staff used the term ‘safety’ in explanations of why and how they were doing things in particular ways. We present three interlinked analytic themes within an overarching narrative of care: caring for the technology; caring for each other; and caring for the patient. Our study revealed a paradox: polypharmacy was visible, pervasive and productive of numerous routines, but rarely discussed as a safety concern per se. Safety meant ensuring medicines were dispensed as prescribed, and correcting errors pertaining to individual drugs through the clinical check. Pharmacy staff did not actively challenge polypharmacy, even when the volume of medicines dispensed might indicate ‘high risk' polypharmacy, locating the responsibility for polypharmacy with prescribing clinicians.

Conclusion ‘Safety’ in the performance of practices relating to polypharmacy was not a fixed, defined notion, but an ongoing, collaborative accomplishment, emerging within an organisational narrative of ‘care’. Despite meticulous attention to ‘safety’, carefully guarded professional boundaries meant that addressing polypharmacy per se in the context of community pharmacy was beyond reach.

• primary care
• qualitative research
• quality in health care

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ .

https://doi.org/10.1136/bmjopen-2020-042504

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Strengths and limitations of this study

Adopts an ethnographic approach, observing the practices of pharmacy staff ‘doing safety’ in the particular context in which it happens, rather than relying on interview accounts.

Two researchers conducted observations, interviews and analysis, allowing different professional perspectives to inform the analysis, enhancing the study’s credibility.

Some aspects of the setting were inaccessible, for example, management decisions about ‘running the business’ of a community pharmacy.

Our findings may not translate readily outside the context of independent community pharmacies, but our interpretations offer useful ways of conceptualising safety across UK and international settings.

Introduction

Safety in prescribing, dispensing and administering medicines is a global public health priority. 1–5 WHO defines medicines safety as ‘protect(ing) patients from harm while maximising the benefits from medication’. 6 Efforts to address medicines safety have traditionally targeted secondary care. Attention is now turning to primary care settings where a growing population of older people with multimorbidity, escalating prescribing and polypharmacy drive a greater burden of iatrogenic harm. 6–10 Community pharmacies provide a key role within medicines management in primary care, integrating multiple tasks related to medication (including but not limited to dispensing and delivering prescriptions, dispensing medicines through multi-compartment compliance aids (MCCAs) and counselling patients through medication use reviews (MURs)) with the need to operate as viable commercial businesses. 11 This work has become increasingly challenging and complex due to polypharmacy, but how safety is enacted and produced in community pharmacy settings amidst this complexity remains poorly understood. 12 13

Polypharmacy is usually defined as the concurrent use of five or more medications. 6 14 Differences in the way polypharmacy is defined and medication data is collected make international comparisons challenging, but several international studies demonstrate increasing polypharmacy in older populations. 15 The risks of polypharmacy are well documented: medicine errors, adverse drug reactions, falls, frailty, hospital admission, increased hospital stay and death. 16 17 In recognition that in some cases people may need multiple item prescriptions to treat their conditions, a distinction has been made between ‘appropriate’ polypharmacy or ‘problematic’ polypharmacy. 18

Medication safety is typically framed as avoidance of error. Professional regulators and leadership bodies encourage reporting of errors, metrics for safe prescribing 5 and removal of inherent weaknesses in the system. 6 A more nuanced approach is now emerging, shifting the focus away from how errors are produced and avoided (which draws attention to a minority of incidents) towards what can be learnt from observing ordinary everyday performance, where—mostly—practice occurs error-free (a ‘Safety II’ approach). 19

Previous work on safety in community pharmacies has presented safety culture as a product of managing the complex relationship between medicines-related workloads and maintaining commercial viability. 20 While safety improvement may be enabled by managers and institutional policies, it is enacted by front-line staff and therefore evolves as a result of this enactment. 11 One study, based on interview data, has suggested that implementation of procedures is subject to an interplay between procedures-as-imagined and procedures-as-done. 21 22 Adopting the term ‘organisational resilience’, Thomas et al 21 call for further research to investigate how organisational culture contributes to decision making and action around implementation of standardised procedures.

We are adopting a safety II orientation to our study of polypharmacy, 23 24 conducting ethnographic and participatory research across primary care settings (patients’ homes, general practice, community pharmacy), seeking to generate ‘practice-based evidence’. 25 We address the research question: How is patient safety constructed in community pharmacy settings in the context of polypharmacy?

This study was part of an in-depth, multisite ethnographic study of polypharmacy in primary care (APOLLO-MM: Addressing the Polypharmacy Challenge in Older People with Multimorbidity - protocol previously published). 23 We conducted an organisational ethnography of routines and practices in four English community pharmacies, pseudonymised Willow, Foxglove (part of Woodland Independent Pharmacy Group), Poppy and Lilac (part of Meadow Independent Pharmacy Group) (see table 1 ). Pharmacies were recruited along with general practitioner (GP) practices to form contrasting research clusters. Each cluster (GP + pharmacies) provide medicine services to our patient participants in the wider APOLLO-MM study. 23

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Characteristics of study pharmacies

Two researchers (NF, a social anthropologist and DS, an academic GP, both experienced ethnographers) undertook data collection and analysis. Data included: ethnographic observations; shadowing staff, inviting them to ‘talk me through what you are doing’; formal interviews; documents (eg, standard operating procedures (SOPs), dosette checklists, to do lists, manufacturer’s guidance identified as relevant through our observations and interviews). We conducted 140 hours observation (December 2017–January 2018; December 2018–February 2019, March–July 2019), focusing on everyday routines and practices concerning polypharmacy and the management of patients with multimorbidity. This work occurred primarily in ‘backstage’ regions of the pharmacies, 26 such as dispensaries and areas designated for preparation of MCCAs—known as ‘dosettes’ at all sites.

We used one-to-one briefing sessions, posters and information leaflets to ensure informed consent from participants. We adopted a ‘processual consent’ approach, revisiting consent iteratively before each occasion of observation. 27

We conducted 19 formal interviews with 21 pharmacy staff identified through ethnographic observations as doing work relevant to polypharmacy and its safety (including one group interview) (see table 2 ). Interviewees signed consent forms in advance. We adopted a narrative approach, using a broad topic guide, inviting in-depth accounts of working practices ( online supplemental file 1 ). We asked participants to attend the interview prepared to share a story relating to polypharmacy. Interviews lasted 14–59 min, were audio-recorded and transcribed verbatim.

Supplemental material

Pharmacy interviews

Data analysis

The dataset comprised 280 pages of typed fieldnotes, 279 pages of transcribed interviews and 46 documents. Fieldnotes were typed after observations/interviews (usually within 24 hours), incorporating reflections and theoretical insights, then shared between NF and DS to prompt further critical reflection guided by our different fieldwork experiences and disciplinary orientations. This informed subsequent fieldwork, and ensured a coherent approach to data gathering. We kept a digital, reflective journal using Evernote, sharing memos, observations and theoretical insights relevant to the wider polypharmacy project. We used QSR NVivo V.12 qualitative data analysis software for data management. 28 The data we present are anonymised; names for pharmacies, interviewees and staff are pseudonyms.

The analysis was inductive, with ‘safety’ emerging early in our analysis as an organising frame for the work of repeat dispensing for patients experiencing polypharmacy. We directed our analysis to the tasks and routines staff undertook, how these constituted notions of patient safety, and how staff accomplished safety-in-practice. 19 Informed by practice theory, we focused on interconnections between people, artefacts, spaces and technologies. Under this lens, organisations are conceptualised as ‘bundles of practices’ and management is an activity aimed at ensuring that social and material activities work more-or-less in alignment. 29 30

Patient and public involvement

We have a project advisory group of 11 members (academics, health professionals, representation from Age UK, two patient members, lay chair). An online patient panel of five members were involved in: proposal development, design of participant materials and project website ( www.polypharmacy.org.uk ), application for ethical approval, project launch event, piloting of interviews, study design and conduct.

‘Safety’ was a collective concern in all pharmacies. Staff used the term ‘safety’ in explanations of how and why they did certain things: picking medicines from shelves in a particular order; asking patients for names and addresses; switching tasks regularly. In naturalistic talk, staff did not articulate what constitutes ‘safety’, but in interviews they referred to safety as ‘the right drug, the right patient, the right time’.

The pharmacies used various technologies (eg, robots, MCCAs, spreadsheets, computers, telephones, printouts, labels, post-it notes) in the process of dispensing (see table 3 ). Willow has two robots which automate in-house dispensing and MCCA production, acting as a ‘dosette production hub’ for all the Woodland pharmacies. Poppy and Lilac had considered automating dosette production but reported it was not financially viable.

Detailed ethnographic description, (known as ‘thick description’) of the four community pharmacies 47

Preparation, storage and delivery of dosettes to support medicines-taking was a prominent working routine across both pharmacy groups, with demand growing despite reports questioning their safety. 31 32 Meadow Group’s manager reported ‘ we are taking on extra work ’ since larger, chain pharmacies were reducing this service. A handwritten poster at Willow showed dosette production increasing 10% from 252 to 278 patients over 7 months. All pharmacies used electronic prescribing systems (EPS) to receive prescriptions from GPs and order prescriptions from GPs on patients’ behalf.

We present three interlinked themes which show how staff accomplish safety within an organisational narrative of care: caring for the technology; caring for each other; caring for the patient.

Caring for the technology

Two technologies, dosette robots and EPS, illustrate how new routines and discourses emerge when technologies are introduced, and how ‘traditional’ technologies such as paper charts, post-it notes and whiteboards remain critical to the safety of medicines routines.

Staff at Woodland pharmacies regularly described the dosette robot, and their work with it, as contributing to patient safety: ‘ Number one reason is patient safety ’; ‘ Everything is for patient safety ’; ‘ We got the robot for patient safety ’. This well-rehearsed collective narrative appealed to staff and drove the implementation and ongoing use of the robot, although staff were never explicit about what constitutes ‘ safety ’ nor how the robot contributed to it. We interpret staffs’ statements about safety as resonating with the robot manufacturer’s such as ‘ increased accuracy ’ compared with the ‘ manual preparation method ’ enabling ‘ the pharmacy to greatly increase safety ’ (Document: robot manufacturer’s website). The website also boasts that dosettes are ‘ proven to boost adherence rates from 61% to 97% ’, and that the robot offers ‘competitive advantage’ through ‘ lower production costs ’, ‘ increase in production speed ’, and a ‘ significant decrease in labour costs ’ (Document: robot manufacturer’s website). The presumed economic benefits were invisible to us; staff did not express any connection between robot and revenue.

Automation of dosette production has not eliminated the need for human care. The robot is never left alone when ‘ in production’ (ie, filling dosettes). It has generated new scope for errors and new working routines to address errors. For example, staff must constantly ‘replenish’ the robot’s 400 translucent blue containers; drugs in underfilled containers are beyond the reach of the robot’s suction arm which lifts drugs one-by-one into the programmed dosette cells. This requires technical knowledge about a drug’s stability and sophisticated local knowledge about how fast the lines are—‘ slow lines ’ demand less frequent attention than ‘ fast lines ’. The ‘ replenishing’ process involves staff ‘ deblistering ’ tablets or capsules from their packaging by feeding blister packs through a deblistering machine, depositing tablets into shallow plastic trays for labelling by drug name, batch number, description and number of tablets. A coworker pours the tablets into the matched robot container, first selecting the correct container lid—with holes just big enough to enable the suction mechanism to pick out a single tablet for each cell. After filling, staff do manual checks to ensure the dosette contains the right number of items per cell and that pills have not accidently ‘ jumped ’ from cell to cell as sometimes happens. Certain medicines (‘ externals ’) are not kept in the robot; they may have limited shelf life after deblistering or be ‘ slow lines’ . Staff add these manually once the robot has completed a patient’s 4-week set.

The pharmacy has protocols and standard operating procedures but when we enquire of their whereabouts the manager says they are ‘locked in a cupboard in the staff room.’ Probing further we discover that although the robot was installed over 2 years ago they are ‘still working’ on their protocol for dosette production which ‘ changes all the time’ . The pharmacy manager continues ‘ we are so busy and demand is increasing. When we reach the pinnacle we will write something. I usually just ask the staff and they tell me what’s the best way ’ (Fieldnote, Willow, 09/01/2018, DS). His quote illustrates the importance of local knowledge, grounded in practice, and how this becomes constructed through informal communication rather than formal protocol.

EPS is central to dispensing routines, but pharmacy staff adopted a range of workarounds to ensure safety that developers of the EPS system may not have envisaged. It was striking that across all pharmacies all prescriptions sent electronically by GPs (via the National Health Service (NHS) ‘spine’) were printed. The working day was punctuated at c.15 minute intervals by staff ‘refreshing’ the EPS screen to view and print new scripts, a routine they considered essential to safe working practice. Only paper had sufficient ‘ecological flexibility’ 33 to enable swift movement of the prescription around different physical spaces in ways which supported their collaborative working—the same paper prescription passed from person-to-person moving in and out of different working routines. Its materiality was important, serving as a handy checklist for picking medicines off the shelves, checking medicines before ‘ bagging up’ , and handing the ‘ right medicines to the right patients ’ (see table 4 ). Jimi, Woodland’s manager, explained that portable electronic devices would not do the job; they have no access to a secure wireless internet connection. Given his innovation with robot technologies, we interpret this not as resistance to technology per se, rather an expression that the technology is insufficiently flexible for tasks required. 33 34

Electronic prescribing routines

Caring for each other

Caring for each other encompasses a number of practices to ensure safe working as a team. Members of staff were always alert, always listening and ready to take initiative. Staff were able to report errors without fear of negative consequences and we experienced a strong commitment to social cohesion.

Throughout our fieldwork we observed staff diligently pursuing their individual tasks but always poised and available to help a colleague, for example, find a drug, check/sign-off a prescription, move to the dispensary to serve a growing queue of patients, replenish the robot:

Caleb, a technician, arrived at work and mumbled something. Rohima turned to him and said ‘ she’s gonna have to call back in half an hour for dosette box issues ’. I realised I had no idea which question she was responding to, or where it had come from. There is such a strong sense in this workplace of people being on the alert to subtle cues from colleagues around the site and I realise I am not always ‘tuned in’ and wonder at what seems like an ‘extra sense’ operating between its members to keep things flowing. (Fieldnote, Willow, 03/01/2018, DS)

We often witnessed staff huddled together to solve a problem, with junior staff encouraged to offer solutions, define processes or suggest procedural changes:

Caleb who has been in ‘ production ’ appears and strikes up a conversation with Jimi, the pharmacy owner—a discussion about Epilim [sodium valproate] 100 and 200 and stability issues. Caleb suggests that as they use so much of these items in one production run he wonders if they could change its status from ‘external’ to ‘ production ’. Jimi considers it and answers back ‘ if we only filled it once at production, turnover is high. ’ Mo, the pharmacist comes over and joins in, suggesting they ask someone. Jimi suggests that Caleb phone Sanofi, the drug company, to ask how long the tablets can remain out of the packets. (Fieldnote 09/01/2018, Willow pharmacy, DS)

‘Externals’ add considerable extra work to dosette production as they are dealt with manually, but this exchange also highlights how notions of ‘safety’ incorporate understandings of supply and demand, drug-related storage and stability, alongside a welcoming of ideas by senior staff.

We also observed open discussion as challenges arise, with junior members of staff taking the initiative to come up with solutions or refine working routines based on their knowledge and expertise:

Jimi addressed a small group of staff, reflecting on a recent ‘ deblistering problem ’ when more than one brand of pill ended up in the same container. He told them to ‘ be alert ’ and made some suggestions for avoiding this in future, acknowledging how difficult it is amidst a ‘ sea of gliclazide ’. A few days later, Laila (dispenser responsible for dosettes) spends her lunch break creating a ‘ deblistering SOP ’. With three steps typed up, she asks Saleem, a pharmacist, what step four should be, adding ‘ I can’t believe this—it is like the easiest thing we do ’ By the end of the lunch break she has five steps: ‘ I will show it to Sameer and Caleb…this is what we do ’. I was struck by the bottom-up, collaborative nature of this exercise. Safety was being worked out on the hoof with everyone included, acknowledgement of its complexity and overall, a sense of commitment and fun. But the formalisation of this into a document seemed at odds with their usual approach of just asking each other. I learn a few days later that the SOP is now an A4 sheet with 12 bullet points stuck on the wall of which Laila is clearly proud. Nina watched Laila stage a quiz in which she tested Linda’s knowledge, with Naihra joking from the sidelines. It is imperfect in its detail, and appears incomplete. Nina asked ‘ Why did you have to do a SOP…have you devised a new routine? ’ Laila ‘ No, it was in our heads. Everyone knew, but it wasn’t written down ’ Everyone was happy. The equilibrium was restored. The SOP is not so much an instruction of what to do but a reflection of what they now do, a product of teamwork and a consolidation of their collective knowledge. (Fieldnotes, Willow, 23/01/2018, DS)

This care for one another created an environment which allowed staff to work collaboratively and openly resolve errors. At Willow and Foxglove in particular, staff were encouraged to identify and discuss errors which were regarded as an inevitable aspect of best practice:

if you haven’t spotted any today, are you doing your job properly or are you asleep on the job, just letting things through? Errors keep you on your toes. (Interview, Pharmacist, Foxglove, 04/02/2019)

In Woodland pharmacies, the category of ‘error’ was noticeably broad and included: discrepancies arising when patient’s medication changed on hospital discharge; robot errors (eg, broken tablets; tablets ‘jumping’ between cells). One consequence of this broad description that incorporated both ‘human’ and ‘technological’ error was that it made talk about errors commonplace, easy, collegiate and—importantly—actionable:

Aiza has grabbed one set of prescriptions belonging to one patient, or so it would seem. Quickly she has spotted an error and tells me ‘ this is something you should see. There’s a mix up on names. Two patients with same surname but different addresses—someone has put both prescriptions together. ’ Aiza lays out the four prescriptions on the island worktop for me to see that indeed two belong to a ‘D’ and two belong to a ‘S’ but they have the same surname. She shows Raheem the error—‘ I almost made up one prescription for two people! ’ She does this in a matter of fact, upbeat way. There’s no blame that it was someone else who put the prescriptions together initially. It’s as if she’s taken responsibility for almost making the error herself, had she not checked the names on the top of the prescription so carefully. (Fieldnote, Foxglove, 16/01/19, NF)

Caring for the patient

Finally, safety emerges out a shared concern to care for patients; automation has not diminished relationships between staff and patients (‘ we know our dosette patients’ ). There are sticky notes and ‘handover sheets’ on the dispensary walls acting as reminders of: ‘ dosette patients ’ holidays/extra dosettes needed; hospital admissions; medication changes. Staff often made themselves available for dosette queries on their days off.

At Poppy, Marie, a dispenser, explained how she used her initiative to adapt their routine for labelling dosettes to accommodate a patient with too many medicines for one dosette (22 morning; 17 midday; 6 teatime; 18 bedtime). Usually one inlay is placed in each dosette listing the medication it contains, its appearance and dose instructions. Marie explained ‘ we actually make two dosette boxes for her, because it doesn’t all fit into [one] box. So she has her pain medications in one box, and in the other box she has the rest. ’ When Marie imagined how the dosette might be used beyond the pharmacy, she placed two inlays within each dosette, so each box listed the patient’s full regimen:

So if she ever went into hospital, say if she only grabbed one dosette box and she only took the pain one and they thought, oh, she’s only on painkillers, and she didn’t take the others (…) It will still have the whole list, so then they’ll say to her, ‘Oh, where’s your other medication because it’s on this?’ (…) Yeah, it dawned on me and she has to go back into hospital, and I don’t know what it’s like, if she’s elderly and she’s rushing, she might only pick up one dosette, and then what? The hospital aren’t going to know what she’s on. (Interview, Dispenser, Poppy, 29/09/2019)

The following extract expresses the reciprocity and strength of staff-patient relationships which endure and surpass the role of automation:

Laila and Saleem are back from their surgery visits to pick up the daily prescriptions. Laila is full of chatter and excitement and has a story to tell. She says that she went into the surgery and it was so full, people everywhere and a really long queue. As she waited, a man, ‘ whose dosette we make up ’ came up to her and ‘ touched her feet, thanked her and said pray for me. ’ The three of us talk about what this might mean. I asked Laila ‘ is he grateful because you make up his dosettes? ’ ‘ I don’t know ’ she replied, ‘ but I was so embarrassed. Everyone was watching me. ’ Saleem asked if she was ‘ anything to him, like an aunty? ’ ‘I’m nothing to him!’ exclaimed Laila, ‘ I’m just the girl in the pharmacy .’ (Fieldnote, Willow, 08/01/2018, NF)

Several participants emphasised the importance of getting the right drug to the right patient at the right time as their top safety priority. Staff speculated on imaginary patients and future imagined scenarios by way of performing safety here-and-now, maintaining a rhetorically persuasive account of their high risk environment and embedding these future abstractions into material structures and systems in-house 35 :

You have to be accurate on what you do. Be prepared, because obviously you have to always double check what you do. It doesn’t matter whichever job you do, and especially if you work in a pharmacy with medication, it’s got to do with someone’s life. As I said, if you give them something wrong, they could end up in hospital, they don’t know where they’re going to end up; they might die, or whatever! (Interview, Dispenser, Foxglove, 04/02/2019) Yes, my main worry is a mistake being made, so I have that at the top of my brain all the time. I’m constantly checking that everything is right, that it is the right meds, it’s the right strength, you know the right tablet, every step. (…) Because I’d hate it. (…) like if it was my nan’s meds or something like that and she said, “Oh, a mistake has been made and I’ve taken the wrong meds!” I wouldn’t be very happy, I’d think, well, I think the whole point of the dosette box is to make sure that vulnerable people, like elderly or those who can’t handle their meds, it’s done for them in the correct way. (…) It is a constant worry, it’s a lot of pressure. (Interview, Dispenser, Lilac, 13/01/2020)

Polypharmacy as a safety issue: whose responsibility?

Our study revealed an important paradox. On the one hand, polypharmacy was visible, pervasive and productive of numerous working routines. On the other, polypharmacy per se was rarely discussed as a safety concern, either between pharmacy staff or between pharmacist and GP. Safety meant close attention to practices ensuring medicines were dispensed as prescribed, and correcting errors pertaining to individual drugs through the clinical check. It did not mean actively challenging polypharmacy per se, even in situations where the volume of prescribing (10+ or 15+ items) might indicate ‘high risk’.

Table 5 illustrates the tension pharmacy staff articulate between dispensing ‘safely’ in the context of inherently risky lists of multiple medicines, from a professional position which distances them from the act of prescribing, the responsibility for which is firmly with the prescriber, usually the GP.

Polypharmacy and safety

Our analysis illuminates the ongoing, collaborative work that constitutes safety across four community pharmacies. The end towards which this work is focused is ‘safe’ dispensing of medicines, broadly understood as ‘right drug, right patient, right time’. The means by which this is achieved is a highly nuanced, ongoing process of organising and reorganising, negotiation and renegotiation. Safety is not fixed or inflexible—as might be assumed in a system standardised by protocols—but is in constant flux and open for adaptation by staff at all levels. From this perspective safety is a verb, not a noun.

Patient safety was not assured because of the implementation of technologies such as dispensing and dosette robots, dosettes or electronic prescribing, but emerged out of a shared concern by pharmacy staff to ‘care’. SOPs did not drive action, but emerged out of collective action; the most useful ones were unfinished ‘work-in-progress’, flexible scripts that remained open to further adaptation (eg, the deblistering SOP, the robot ‘protocol’). In addition to learning from errors, staff shared stories of caring for a collective imaginary—imagined scenarios of what might happen if medicines are not dispensed carefully and safely. The collective imaginary is rhetorically powerful, effective in sustaining staff orientation towards safety practices in an inherently risky context. Care is the glue that ensures patient safety and encompasses care for relevant technologies, care for each other and care for the patient. Following a Safety II approach, we have shown how pharmacy staff continuously adapt their routines to ensure ‘as many things as possible go right’ and that medicine safety can be assured ‘to succeed under varying conditions’. 19 Sophisticated understandings of how the everyday actions of healthcare staff produce safety are essential as the organisational contexts within which healthcare is delivered become increasingly complex.

The absence of explicit talk about polypharmacy, or the relationships between polypharmacy and safety—even though we became known as the ‘polypharmacy researchers’—surprised us. This was not unique to the pharmacies in our study; we did not observe naturally occurring talk about polypharmacy in the GP practices taking part in our wider APOLLO-MM study either (not yet published). While the pharmacists, technicians and dispensers worked hard to ensure ‘safety’ for their patients affected by polypharmacy, they did not consider they had any legitimate warrant to challenge it, and located the responsibility for the prevalence of polypharmacy with different parts of the health system, usually GPs. The MUR—as the name suggests—was framed by participants as an exploration of ‘use’ of drugs, not an opportunity to question polypharmacy per se. Patients affected by polypharmacy did not constitute a target group for MURs. 36

Strengths and weaknesses of this study

To our knowledge, this is the first ethnographic study conducted in community pharmacy that has focused on polypharmacy and its intersection with safety practices. A key strength of our ethnographic approach was the opportunity to spend many hours observing the detailed practices of staff ‘doing safety’ in dispensing medicines in the particular context in which it happens, rather than relying on abstracted interview accounts alone. Although our pharmacies varied in terms of the populations they served, all belonged to independent pharmacy groups (3–5 pharmacies in each group). Our findings may not translate readily to larger chain pharmacies, but our interpretations may offer useful ways of conceptualising safety across UK and international settings.

Not everything was easily visible to us as ethnographers. We did not have access to some aspects of pharmacy work, such as management decisions about ‘running the business’ of a community pharmacy, or the relationship between the financial and clinical dimensions of pharmacy work. This may have special relevance in polypharmacy in a health system such as the NHS where dispensing fees are paid to pharmacies on a ‘per item’ basis. Our study contributes to a body of qualitative research by foregrounding ‘hidden work’ and illuminating the creative ‘tinkering’, practical judgements and situated knowledge that is often missing from professional accounts and policy documents, but which is essential to ensuring technology assisted routines are safely implemented. 13 37–40 In contrast to previous work conducted in pharmacy settings our observations show that staff are adept at maintaining safe practices and resolving errors despite constraints such as limited space and interrupted work flows. 41 42

The meaning of the study

Our study sheds light on the often hidden work that pharmacy staff undertake in increasingly complex, high-risk settings fueled by escalating prescribing. While some policy literature acknowledges a need to help ‘practitioners manage workload related to polypharmacy in order to improve medication safety’, 6 we argue that policy-makers could take greater account of practice ‘on the ground’ to inform guidelines by acknowledging how pharmacy professionals are currently working to ensure medication safety in high risk situations, such as those presented by polypharmacy. Furthermore, the policy literature focuses on distinguishing between appropriate and problematic polypharmacy. 18 43 44 However, these are terms that we did not hear used in the pharmacy settings we were given access to. This suggests that policy level pronouncements have not found their way to those on the ground or that the terms used by policy makers and academics do not resonate with those working on the front line of polypharmacy.

Future research

There have been calls for a greater role of pharmacists in managing high risk and problematic polypharmacy, 6 45 including the integration of clinical pharmacists within primary care to deliver Structured Medication Reviews under the new 2020/21 GP Contract to patients affected by complex problematic polypharmacy. 46 Community pharmacists in our study did not feel it was within their remit to challenge prescribing regimens initiated by other healthcare professionals in the healthcare system. Further research is needed to understand how these different professionals (community pharmacists; clinical pharmacists within general practice settings; prescribing doctors and nurses) and new professional arrangements work together to negotiate and address complex polypharmacy and with what consequences for patients. We will consider the role of GPs and other health professionals in supporting or challenging polypharmacy in our wider research.

Acknowledgments

We would like to thank staff from the four community pharmacies who agreed to participate in this study, colleagues at QMUL who commented on an early draft of the manuscript, and our Expert Advisory Group and Patient Panel for their support of our research.

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• National Health Service

Twitter @ninafudge

Contributors Both authors meet the ICMJE criteria for authorship. The study was conceived by DS. Data gathering and data analysis were jointly undertaken by DS and NF. NF wrote the first draft of the paper. Both authors revised and finalised the manuscript.

Funding This work was supported by the National Institute for Health Research (NIHR) Clinician Scientist Award number CS-2015-15-004. Additionally, this work was supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames.

Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Competing interests None declared.

Patient consent for publication Not required.

Ethics approval The project has ethics approval from Leeds West Research Ethics Committee (IRAS project ID: 205517; REC reference 16/YH/0462).

Provenance and peer review Not commissioned; externally peer reviewed.

Data availability statement No data are available. Our ethics approval and consent procedures were based on the anonymity of the individuals who participated, hence further access to the full data set cannot be granted.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Polypharmacy: putting the framework into practice

This article describes how to apply the polypharmacy framework at individual patient level through the use of a case study.

UrbanImages / Alamy Stock Photo

In ‘ Polypharmacy: a framework for theory and practice ’, a broad framework was suggested to be considered when undertaking polypharmacy reviews (see Box 1). This article will illustrate the application of these principles in a case study, which involved undertaking a comprehensive review. Tackling a smaller number of prioritised care issues in practice is equally valid. 

The patient, Linda, consented to her case being used in this article.

Box 1: Framework to consider when undertaking polypharmacy reviews

• Aims  — clarify what the patient is taking, whether they can manage their current medicines and any current support systems they have in place. Establish the patient’s wishes and priorities for their medicines, including others who are involved in their care, as appropriate.
• Need  — review the need for each prescription by considering whether it is essential and has an ongoing valid indication.
• Effectiveness  — ensure ongoing benefit of all agents in context of the patient’s frailty, life expectancy and wishes, the best available evidence and numbers needed to treat (NNTs). Consider quality (symptomatic treatment) versus quantity (preventative treatment) of life and outcomes important to the person.
• Safety  — review current and future risks.
• Efficiency — consider whether medicine could be given in a cost-efficient, simpler manner.
• Acceptability  — agree a plan for change with the patient and family/carers, as appropriate. Provide options, including maintaining status quo. Check the patient’s understanding.
• Document  — ensure your plan is clearly documented and shared with others involved in the patient’s care.
• Monitor — follow-up with the patient and adjust as appropriate.

This framework should be viewed as a guide. Pharmacists may use existing national polypharmacy frameworks and resources to develop their own systematic approach to medication review.

A patient on multiple medicines who is struggling with symptoms and adherence

Linda is aged 64 years and has multiple health problems, struggling daily with mobility and pain. She lives at home with her husband, who assists her with daily tasks, and enjoys looking after her grandchildren.

Linda is attending the pharmacist-led polypharmacy clinic at her GP surgery in Fife for the first time and the systematic approach outlined in Box 1 is used during the consultation with her.

Presuming that she is taking her medicines as listed on the patient medical history should be avoided. In advance, ask her to bring her medicines to her appointment. Before the consultation, you could also post her a copy of the ‘Me and my Medicines’ charter — a way of encouraging conversation around medicines between the patient and healthcare professional — to support shared discussions [1] .

Table 1 summarises the patient’s medical and drug history, and baseline laboratory values.

First, ask Linda what matters to her in terms of her medicines; explore how she is currently using them and how they fit into her typical day. From the GP computer system, you know she is rarely collecting her co-codamol and fluticasone propionate nasal spray. You understand that adherence decreases as medicine burden rises and would like to explore this further in a non-judgemental way by asking Linda some questions [2] .

Linda is not sure what all her medicines are for and is keen to take fewer, if it is safe. Specifically, she wants to know if her venlafaxine is still needed, because she has been taking this for some time.

She stopped taking her co-codamol and fluticasone proprionate nasal spray (Flixonase; GlaxoSmithKline UK) a while ago because she felt these were ineffective. However, she indicates she is still experiencing chronic pain and her priority is to improve control of this pain. She perceives nefopam as her “best” medicine and would “like to take more” if she could. Her tramadol intake is erratic and she reports taking them at 08:00, 16:00 and before bed. She says she is often busy during the day with her grandchildren and does not always have time to take all her analgesia.

Patient priorities

Linda wants to have better symptom control of her back and knee pain, and to take less medicine because she worries that “the tablets are taking over my life”.

Together, you agree that the aims of today’s appointment are to:

• Focus on improving her pain control;
• Identify opportunities to simplify her medication regimen and focus on venlafaxine at her request.

Although Linda is prescribed a range of medicines, it is important to establish whether there is still an indication for these.

Consider original indications and treatment duration

By systematically matching Linda’s medicines to her coded patient medical history, you find no clear indication for:

• Aspirin — no personal history of vascular disease;
• Bumetanide — an unusual choice for hypertension, her only coded cardiovascular diagnosis;
• Fluticasone propionate nasal spray — a medicine she has stopped anyway.

Her medical history shows that aspirin was started during a hypertension review ten years ago and bumetanide was started for ankle oedema around three years ago. There are no cardiology letters on Linda’s file nor any references to heart failure, and an electrocardiogram during her most recent hypertension review showed normal sinus rhythm. Fluticasone propionate nasal spray was prescribed a few years ago during summer for allergic rhinitis.

Although Linda has a coded history of depression and acne rosacea, she has been taking venlafaxine and lymecycline continuously for eight and four years, respectively. This indicates the need to ask Linda about her mood and current rosacea symptom control.

Group by clinical indication

Grouping medicines together by indication is useful to identify tablet burden and potential therapeutic duplication. For Linda, this applies to her:

• Analgesia — co-codamol, tramadol and nefopam;
• Cardiovascular medicines — doxazosin, ramipril and bumetanide.

Consider the available evidence

Evidence suggests that aspirin should not be prescribed for patients such as Linda without overt cardiovascular disease, because certain risks (e.g. bleeding risk) outweigh benefits [3] , [4] . For patients aged over 55 years, the National Institute for Health and Care Excellence hypertension guidelines favour a calcium-channel blocker as the antihypertensive of choice [5] . In Linda’s case, as she has ongoing ankle oedema, it is reasonable not to favour this as a first-line agent.

In terms of venlafaxine, questioning its ongoing need is appropriate because Linda has been treated beyond standard treatment durations. According to national guidelines, patients should start treatment for six months initially, but anyone at risk of relapse should be treated for up to two years [6] . This was Linda’s first course of antidepressants and they were started by her GP at the time of her daughter’s illness, which is now resolved. Linda reports her current mood as “good” and, following discussion with the initiating prescriber, gradual withdrawal seems appropriate.

Regarding Linda’s prescription for the antibiotic lymecycline, topical agents are recommended as first-line treatment [7] . Both local and national guidelines advocate restricting oral antibiotic treatment to 12 weeks when they are deemed appropriate [7] , [8] . Thereafter, intermittent use, or periodic breaks in treatment — known as ‘drug holidays’ — should be considered. Linda describes her rosacea as “mild” and is willing to try a topical preparation to allow her to “cut out one more pill”.

Consider essential and non-essential items

Prior to any change to Linda’s bumetanide, the presence of heart failure (left ventricular systolic dysfunction) must be excluded through review of her records and enquiry around clinical symptoms. Case note review shows:

• Bumetanide was started for ankle oedema;
• There are no cardiology letters on file;
• There are no references to heart failure in records of Linda’s GP consultations;
• There is no echocardiogram on file;
• A recent electrocardiogram (ECG) showed normal sinus rhythm.

Linda is short of breath on mild exertion, but is notably obese. She is not short of breath at rest, nor does it wake her from sleep. National guidance is clear that diuretics are usually essential for symptom control in heart failure, but are not indicated for dependent ankle oedema (i.e. oedema which appears to be influenced by gravity) [9] .

Effectiveness

Although Linda has a documented indication for several of her medicines, it is important to establish whether she is getting meaningful therapeutic benefit and to set realistic treatment goals for her.

Though Linda is only aged 64 years, frailty is a stronger predictor of her vulnerability to medicine-related harm than age alone [10] . She rises with effort from her chair in the waiting room and walks to the consulting room using a walking stick at a slow pace. When first asked about her general health, she describes day-to-day fatigue, limited physical activity and says she requires help from her husband for transportation, housework and in managing her medicines.

Using the Rockwood Clinical Frailty Scale (see ‘ Polypharmacy: a framework for theory and practice ’), you categorise Linda as ‘vulnerable’ or ‘mildly frail’ [11] .

Blood pressure

When agreeing realistic treatment goals for Linda’s blood pressure (BP) medicine, her comorbidities and frailty are relevant. Linda has no personal history of vascular disease, diabetes or other compelling indications for her cardiovascular medicine. It could therefore be argued that Linda’s BP control is tighter than required and could be relaxed, aiming for a target of <140/90mmHg.

Assessing benefit in relation to painkillers is important as they contribute significantly to Linda’s treatment burden. Multiple analgesics may be required to control Linda’s pain, but if she is taking them without benefit, she is at increased risk of adverse drug reactions (ADRs) without clear clinical gain.

Use of the SOCRATES mnemonic for pain assessment helps you establish relevant information about Linda’s pain:

• S ite — located primarily in her back and her knees;
• O nset — has been present for several years and is relatively stable;
• C haracter — presents as a dull ache;
• R adiate — does not radiate or travel to other parts of her body;
• A ssociation — is associated with constipation;
• T ime course — is worse in the middle of the day and when she is in bed;
• E xacerbating/Relieving factors — is exacerbated when she walks long distances and relieved by rest and heat;
• S everity — Linda reports remaining “very sore” despite her analgesics, rating her current pain as 7 out of 10 on a numerical rating scale (where 0 = no pain; and 10 = worst possible pain) [12] .

Linda has been co-prescribed tramadol and co-codamol for several years, although has stopped co-codamol owing to lack of effectiveness. There is limited evidence to support long-term opioid use in chronic non-malignant pain and the co-prescribing of different strength opioids (e.g. tramadol and co-codamol) is not endorsed [13] , [14] , [15] . In addition, opioids such as tramadol are best used in conjunction with non-opioid analgesic medicine (e.g. paracetamol), to minimise opioid dose and side effects [14] . By discontinuing Linda’s co-codamol, Linda may not longer be benefiting from combining a step-1 analgesic (i.e paracetamol) with her other analgesics.

Although Linda believes nefopam to be her most effective painkiller, there is limited evidence of its effectiveness [16] , [17] . However, it is important to listen to Linda’s views. You may therefore choose not to prioritise changing nefopam at this point.

Linda’s obesity is relevant, but her pain currently limits her functional ability. Therefore, analgesia optimisation is required before Linda can be supported to increase her physical activity. Medicine administration timing is also important for effective analgesia with regular dosing preferred. This is relevant to Linda, whose current analgesia use involves large gaps between doses [16] , [18] , [19] .

Overall, Linda agrees that her current painkiller regimen is cumbersome and not particularly effective, she is willing to consider different options for managing her pain.

In relation to Linda’s bumetanide, clinical examination reveals she is still troubled by swollen ankles and is unsure whether she has benefited from this ‘water pill’. Computer records show the dose was escalated six months ago from 1mg to 2mg daily, but nothing in the consultation indicates this resulted in increased clinical benefit. Linda confirms limited improvement in her fluid retention from the higher dose, but has “persevered”.

During the consultation, Linda confirms she has no personal history of stroke, coronary or peripheral vascular disease. To support an informed decision about stopping, you decide to use numbers needed to treat (NNT) data and published evidence [20] .

When prescribed for primary prevention, NNT data show that aspirin has a very high annualised NNT (1,428) to prevent one serious vascular event. This, in combination with a discussion around recent evidence, shows that bleeding risk outweighs vascular benefits in patients without a personal history of vascular disease [3] , [4] . Following this, Linda is happy to stop her aspirin.

Potentially inappropriate prescriptions

Applying the ‘screening tool of older people’s potentially inappropriate prescriptions’ (STOPP) and Beers criteria tools to Linda’s medicines highlights the following:

• Loop diuretics are not indicated for dependent ankle oedema, nor first line for hypertension;
• Aspirin in patients with no history of coronary, cerebral or peripheral arterial events is not indicated;
• Alpha-blockers (e.g doxazosin) carry high risks of orthostatic hypotension, syncope and falls, and are not routinely recommended for hypertension [21] , [22] , [23] :

Medstopper is an online deprescribing resource that references STOPP/START and STOPPFrail criteria, as well as Beers criteria, and assists risk prioritisation through assigning ‘medicine stopping priorities’ [19] , [20] , [21] . Medstopper ranks Linda’s aspirin and venlafaxine as the highest priority for stopping.

Risk of hospital admission

Linda takes five medicines that are considered high risk:

• Aspirin (antiplatelet medicine);
• Bumetanide (diuretic);
• Ramipril (an angiotensin-converting-enzyme inhibitor);
• Co-codamol and tramadol (opioid analgesic medicines);
• Venlafaxine (antidepressant medicine) [24] , [25] , [26] .

Using the Anticholinergic Cognitive Burden Scale, Linda’s prescriptions for doxazosin, ramipril, codeine, tramadol and venlafaxine are all classed as high risk for falls, and bumetanide is classed as moderate risk for falls [27] .

Cumulative toxicity

When considering drug–drug combinations and drug–disease interactions that increase Linda’s risk of ADRs, two medicines that increase risk of renal injury — ramipril and bumetanide — are noted. This is magnified by her pre-existing renal impairment. In the context of Linda’s most recent estimated glomerular filtration rate (eGFR), the  BNF indicates the current dose of ramipril may require reduction (maximum daily dose of 5mg if eGFR 30–60mL/min/1.73m 2 ) [28] .

The concurrent prescription of tramadol and venlafaxine increases Linda’s risks of serotonin syndrome, and while she remains on both aspirin and venlafaxine, is at increased risk of gastrointestinal (GI) bleeding. Linda’s  anticholinergic cognitive burden (ACB) score reveals that Linda has a total ACB score of 4 (high risk), with nefopam having the highest individual drug score of 2 (see Figure).

Discrepancies between numerical ACB scores assigned to different medicines exist in the literature and among available scoring tools. Pharmacists should consider the pros and cons of available scoring systems and be able to justify their use of a certain system. For example, the ACB Calculator tool states that to avoid the under-estimation of risk, where discrepancies exist, they have chosen to use the highest available score for a medicine.

Figure: the ACB calculator tool

Source: Reproduced with permission from Rebecca King and Steve Rabino

Side effects

Linda does not immediately make the connection between any of her medicines and ADRs. However, specific questioning around anticholinergic side effects, such as dry mouth and falls, reveals that although Linda has not fallen recently, she does have a fear of falling. She describes her balance as “poor” and says she can be light-headed on rising. In addition, she feels sleepy and sluggish during the day and says she often has a dry mouth and always feels thirsty. Urinary symptoms resulting from the larger dose of her diuretic trouble her, as she stated “I always need to know where the next toilet is”.

You decide to proactively check lying and standing BP based on:

• Linda’s self-reported dizziness on rising;
• Knowledge that one in five older adults living at home experience postural hypotension [29] ;
• Linda’s multiple anti-hypertensive medicines;

Postural hypotension is defined as systolic drop of greater than 20mmHg and diastolic drop of greater than 10mmHg within three minutes of standing compared with sitting or supine position [30] , [31] . Linda’s BP of 116/76mmHg (lying) and 120/74mmHg (standing) do not meet the criteria for postural hypotension. However, both readings are low in the context of her frailty and lack of vascular history.

The potential impact of venlafaxine on Linda’s BP control is worth considering, as this serotonin-norepinephrine reuptake inhibitor is not recommended in patients with uncontrolled hypertension [32] . However, Linda currently has low BP (venlafaxine is more commonly associated with hypertension) and the core issue for her is the review and de-escalation of her anti-hypertensive medicine.

Cost-effectiveness

Linda already takes the most cost-effective formulations of many of her medicines, for example: ramipril (capsules as opposed to tablets); co-codamol (tablets as opposed to capsules or effervescent formulations); and doxazosin (standard as opposed to modified release [MR] tablets). However, the following points need to be considered:

• Venlafaxine has a higher acquisition cost than other recommended first-line antidepressant drugs, such as fluoxetine;
• Fluticasone proprionate nasal spray is more expensive than other first-line generic agents e.g. beclomethasone nasal spray;
• Lymecycline costs more than oral oxytetracycline or topical metronidazole, which are recommended first-line treatments for acne rosacea;
• Nefopam is a non-formulary analgesic in NHS Fife and has been identified as not cost effective by the PrescQIPP bulletin [16] .

Importantly, medicines are only cost effective if:

• They have clear ongoing indications;
• Patients are willing and able to take them as prescribed;
• They provide clinical benefit.

For venlafaxine and aspirin, evidence of ongoing need is lacking, and savings can be achieved by reducing or stopping these high-risk drugs. Linda already admits non-adherence with fluticasone propionate and co-codamol and therefore, both can be removed from her repeat list to avoid accidental re-ordering.

Linda is on an unusual dose of doxazosin, requiring her to take two different strengths (4mg and 2mg). You aim to tackle this as part of your plan to pull back on Linda’s antihypertensive medicine intake.

If venlafaxine was still required, a once-daily MR formulation may have reduced the complexity of Linda’s regimen, albeit at a higher cost.

Tramadol (as standard capsules) is the most cost-effective formulation, but may not offer value for money as Linda struggles to fit four-to-six hourly dosing into her day and, therefore, benefit may be limited. If MR formulations of tramadol were selected, then PrescQIPP recommends generic MR capsules, as tablets are not currently listed in part VII of the Drug Tariff [16] . If this is locally endorsed as a cost-saving approach, there is an option to prescribe branded generics [16] .

Moving from an oral to a topical antibiotic for Linda’s rosacea offers another chance to reduce her tablet burden.

Acceptability

Agree a plan for change.

Reviewing the information gathered from the previous sections, you are clear that Linda is:

• Taking several high-risk medicines;
• Potentially lacking a valid ongoing clinical indication for aspirin, lymecycline, venlafaxine and bumetanide;
• Is experiencing medicine-related side effects (e.g. urinary frequency, daytime fatigue and poor balance).

There are many opportunities for change, but it remains crucial to discuss and agree a prioritised plan for change that is acceptable to Linda. It is important to discuss benefits and risks of each of Linda’s medicines in a way she understands, and to decide jointly on either to continue the current regimen or to make changes and how this will be managed.

The Tasmanian Primary Health Network provides online guidance on the appropriateness of abrupt and tailored stops for individual medicines [33] . For example, an immediate stop of aspirin and lymecycline is appropriate, whereas venlafaxine and bumetanide require more gradual reductions. There are also several helpful websites supporting shared decision making with patients (see Useful resources).

Venlafaxine

Linda says she is particularly keen to review her ongoing need for an antidepressant. Targeting venlafaxine for change is reasonable because you have previously identified it as a high-risk falls medicine (ACB score of 1). It also increases GI risk in combination with aspirin. Dizziness and sedation are common side effects, both of which Linda has been experiencing and would be keen to reduce.

Antidepressants are a class of specialist drugs where discussion with the original prescriber is advised to plan whether and how to discontinue [8] . In Linda’s case, her venlafaxine was initiated by her regular GP, who agrees to a planned withdrawal when you approach them for advice.

Following tapering advice from Medstopper, you agree to reduce venlafaxine slowly from 37.5mg twice daily to 37.5mg once at night, dropping the morning dose in view of Linda’s daytime fatigue [34] .

Pain medicines

For Linda’s analgesia, you agree to remove co-codamol from her repeat list because she has not been taking it, nor is it recommended in combination with her tramadol. You both agree to focus on the regularity of Linda’s other analgesics by suggesting to change her tramadol from two 50mg capsules three times per day (at 08:00, 16:00 and before bed), to a slightly lower overall daily dose of one 50mg capsule four times per day. Although this requires Linda to take her tramadol more frequently, it reduces the overall number of capsules from six to four daily, and may improve the fatigue and dizziness that she has been experiencing.

You discuss the possibility of MR tramadol if Linda struggles with four times per day dosing, but currently, Linda is happy to try the short-acting formulation and to link her dosage to breakfast, lunch, dinner and bedtime to support regular dosing.

You would like to discuss her nefopam further, because it is a high-risk drug, but owing to Linda’s perceived views that this is her most effective painkiller, you agree not to change this now. It is something to be reviewed in the future.

Although Linda wishes to reduce the number of tablets, you explain you would like to try reintroducing regular paracetamol because this may allow further future reductions in her stronger painkillers, tramadol and nefopam. As a result, it will reduce her risk of falls, sedation and dizziness. You ask Linda to report any benefits to her pain, day-to-day function or if she experiences better quality sleep following a four-week trial of paracetamol, using your baseline numerical pain score of 7 out of 10. You agree to stop this if there is no obvious benefit.

It is important also to discuss with Linda that medicine is only part of the available treatment for her pain and to encourage her to consider additional non-pharmacological approaches, such as exercise, pacing (process of balancing activities and rest) and the application of heat.

Cumulative risk

You agree to stop Linda’s aspirin explaining this also avoids the need for an extra pill for gastro-protective effects had she continued in combination with venlafaxine.

Linda’s BP and the use of three antihypertensives, ramipril, bumetanide and doxazosin, is another clinical priority. However, there has been a sufficient amount of clinical changes in this consultation.

You spend some time discussing the Scottish patient safety programme ‘sick day rules’ advice , which applies to Linda’s ramipril and bumetanide [35] . Both of these medicines increase the risk of acute kidney injury if they are continued during an episode of acute dehydrating illness, for example, diarrhoea, vomiting or fever. You also arrange a phlebotomist appointment to recheck Linda’s renal function, which was most recently checked nine months ago.

You mention that you would like to tackle doxazosin first because its dosing is cumbersome (two different tablet strengths) and it is strongly associated with falls and dizziness. The review of Linda’s antihypertensives is an example of clinical decision making where there is more than one option. It would be equally reasonable to argue for an initial trial reduction in bumetanide, another potentially high-risk agent that is causing side effects (e.g. urinary frequency), which reduce Linda’s quality of life, or a reduction in ramipril in line with Linda’s current renal function.

Acne rosacea

You agree not to change Linda’s acne treatment today, but document in the future that Linda is keen to move from tablets to a topical preparation to reduce her tablet burden further.

The following changes to Linda’s prescriptions have been made: 

• Reduction in venlafaxine to 37.5mg once daily at night;
• Removal of co-codamol and fluticasone propionate from her repeat list as she is no longer taking them;
• Stop aspirin 75mg once daily;
• Change in tramadol dosing from 100mg three times daily to 50mg four times daily;
• Addition of regular paracetamol.

It is important to check that Linda has understood this plan. ‘Teach-back’ is a useful tool for this — ask her to explain her understanding of what has been agreed and what will happen next [36] .

Consider providing Linda with a written summary of the agreed changes to take away and, with her permission, share with her husband who provides support in relation to managing her medicines.

After the consultation, using your notes, you document your agreed changes, rationale, how you will monitor these and your plan for follow-up. Table 2 shows how Linda’s initial pharmaceutical care plan was documented within the GP system.

To improve joined-up care and allow broader support for Linda in managing these changes, seek Linda’s permission to share your plan with the local community pharmacy. Linda does not regularly see any hospital consultants or practitioners outside of your practice team. However, if she did, it might have been useful to share a summary of the plan with them. ‘ My medication passport ’ is one method of supporting transfer of medicine-related information across the interface [37] .

To ensure your plan is both safe and effective, ongoing monitoring of Linda’s pain, mood and anxiety is required. See ‘ Polypharmacy: a framework for theory and practice ’ for suggested validated tools to assist in objectively monitoring change, such as visual analogue pain scores, anxiety and depression scoring tools. If Linda’s doxazosin and bumetanide are subsequently reviewed, then changes to clinical symptoms, such as shortness of breath and leg oedema, should be assessed. Clinical parameters, such as BP and renal function, must also be monitored.

In relation to her immediate changes, agree to contact Linda by phone in two weeks to see how she is managing. Make a follow-up, face-to-face appointment for four weeks time and emphasise her husband would be very welcome to attend this. For safety purposes, advise that she contacts you, the practice team or her community pharmacist if she encounters problems between now and when you next speak, specifically around any worsening of her pain, mood or anxiety.

Over the next few months, you and Linda meet a further three times and, eventually, Linda’s medicines reach stability (see Table 3).

Venlafaxine has now been stopped completely and Linda’s mood remains good. Linda was also able to fully discontinue her nefopam, initially moving to ‘as required’ use in combination with regular tramadol and paracetamol, which had greatly improved her pain. Linda’s BP control allowed her to reduce her doxazosin from 6mg to 4mg once daily. This was followed by a reduction in her diuretic dose from bumetanide 2mg to 1mg daily and an improvement in Linda’s dry mouth and urinary symptoms. Overall, Linda felt less sleepy and dizzy, and her mobility improved.

It is important when reviewing patients to know when further deprescribing is inappropriate. For Linda, complete discontinuation of her bumetanide was not an option she wished to consider, but she is aware she could revisit the issue in the future if improvements in mobility and weight loss reduce her oedema further.

Polypharmacy reviews should not be one-off interactions and pharmacists must be mindful that best outcomes are achieved through careful follow-up and by adopting a partnership approach with patients and other professionals involved in their care.

Main outcomes at patient level

Linda’s overall number of medicines reduced from ten to six in line with her desire to reduce medicines complexity. More importantly, Linda’s pain has improved, she feels better (less drowsy and constipated) and is managing her medicines well. Linda’s falls risk is reduced (ACB score reduced from 4 to 0 through discontinuing venlafaxine, co-codamol and nefopam), her GI risk is lowered by discontinuing her aspirin and venlafaxine, and her risk of renal injury is lowered by reducing her diuretic.

The direct cost savings associated with Linda’s drug changes were calculated as approximately £400/annum.

Main outcomes at health board level

On a wider scale, an evaluation of face-to-face polypharmacy reviews undertaken in a larger cohort of 180 patients within NHS Fife show that:

• Medicine change, particularly around high-risk medicines, can be achieved, with 55% of interventions related to medicine reductions/discontinuations; and 60% of reduced and 49% of stopped medicines were ‘high risk’;
• Changes showed high levels of sustainability, with 86% maintenance at six months follow up;
• Reviews were well received by patients, with 88% of patients willing to attend a pharmacist-led clinic again; and 88% happy with appointment outcomes;
• Annualised drug savings of approximately £200/patient were achieved [38] . 

Useful resources

Deprescribing guides

• Primary Health Network Tasmania. Deprescribing resources. 2019. Available at:  https://www.primaryhealthtas.com.au/resources/deprescribing-resources
• Deprescribing.org. Deprescribing information pamphlets. 2019. Available at:  https://deprescribing.org/resources/deprescribing-information-pamphlets

Shared decision making

• NHS Scotland. Polypharmacy Guidance. Shared decision making. Available at:  http://www.polypharmacy.scot.nhs.uk/polypharmacy-guidance-medicines-review/shared-decision-making
• University of Ottawa. Patient decision aids. 2019. Available at:  https://decisionaid.ohri.ca/index.html
• National Institute for Health and Care Excellence. Search results for ’patient decision aids’. Available at:  https://www.evidence.nhs.uk/search?q=patient+decision+aids

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Polypharmacy in Older Adults: A Case Study

Affiliations.

• 1 Robert J. Dole VA, Wichita, Kansas.
• 2 Avera Behavioral Health Hospital, Sioux Falls, South Dakota.
• 3 Department of Psychiatry, University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.
• 4 Child and Adolescent Psychiatry Fellowship Program, Department of Child and Adolescent Psychiatry, University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota.
• PMID: 36898199

Polypharmacy is defined as concurrent use of multiple drugs for one or more conditions. The occurrence of polypharmacy in vulnerable populations, particularly the elderly, is frequent. Increased incidents of adverse drug reactions and drug-drug interactions plus high costs are not offset by a noticeable improvement in outcome. The practice of polypharmacy persists despite frequent adverse outcomes and reduced effectiveness. We present a case in which an elderly woman presented with falls and delirium. She was taking multiple medications for anxiety and depression in addition to several psychoactive medications for pain, restless leg syndrome, muscle spasms, blood pressure and many nonpsychoactive medications for other conditions. In total, she was taking 24 medications, many of which were likely contributing to her presenting problems.

Copyright© South Dakota State Medical Association.

Publication types

• Case Reports
• Drug Interactions
• Drug-Related Side Effects and Adverse Reactions*
• Polypharmacy*